WO2006114004A2

WO2006114004A2 - A remote controlled tubular implant device and implanting apparatus

Info

Publication number: WO2006114004A2
Application number: PCT/CA2006/000737
Authority: WO
Inventors: Mohammad Nadeem Qadir; Ehtisham Qadir Sheikh; Sheikh Hafeez Ullah; Saeeda Baigum; Soban Qadir; Zargham Qadir Sheikh; Saeeda Seemien; Waseem Qadir Sheikh; Saeeda Sadaf
Original assignee: Hafeez, Naila
Priority date: 2005-04-25
Filing date: 2006-04-24
Publication date: 2006-11-02
Also published as: EP2083698A2; CA2507142A1; KR20080034093A; AU2006239700A1; CN101232848A; WO2006114004A3

Abstract

The 'Novel' tubular implant device is placed in male and/or female's tubes, ducts, vessels, urethras, ureters and/or any conduits etc. as an alternative to and/or substitute for the lumen path for blocking, regulating, dilating, and/or constricting partly, completely, or regulatory for continuous and/or for a specific time or for repetitive cycles to control lumen paths of tubes, ducts, vessels, urethras, ureters and/or any conduits etc. The control of blocking, regulating, dilating, and/or constricting fluid flow path and/or lumen of tubes, ducts, vessels, urethras, ureters and/or any conduits etc. can be exercised by using remotely, locally, and/or automatically the said Novel tubular implant device which may also be activated as a result of changes in values of specimens, parameters where it is implanted, or driven by software program selection remotely or locally when meeting, exceeding, or lowering specific condition(s) or predicting specific analysis of current and historical measurements criteria

Description

TITLE: A Remote Controlled Tubular Implant Device and Implanting Apparatus

Description

BACKGROUND OF THE INVENTION:

The world population of 6 billion is expected to reach 10.7MIlion^~by 2050. Given the strain on global resources and the environment today, it is clear that an environmental disaster is "waiting to happen, as the population time bomb ticks away. While reproduction, as part of family life, is a fundamental human right, we must also consider that right come with responsibilities. We have a responsibility to future generations, and population control is one method of ensuring that there will still be some natural resources left for our descendants.

Apart from these general consensus, one of the tantamount disturbing issue however is the "children having children". One in every 10 births worldwide is to a mother who is herself still a child. Complications from pregnancy and childbirth are the leading killers of teenage girls in the developing world. Each year, 1 million children born to teenage mothers die before Hieir first birthday, and girls in their teens are twice as likely to die from pregnancy and childbirth-related causes compared with older women. Research suggests that very young mothers - aged 10 to 14 - have maternal mortality rates five times higher than women aged 20 to 24. Educated girls tend to marry later, have fewer children, and raise healthier, better-nourished children. They also are more likely to send their children - including girls - to school. An estimated 115 million primary school-aged children worldwide are not now in school; 60 percent of them are girls. Birth rates for teenage giris in the United States have declined in recent years, but they remain much higher than in any other industrialized country. Nearly 900,000 teenage girls become pregnant in the United States alone each year. Throughout the developing world, alarming numbers of children are having children, with tragic consequences in more than 50 developing countries. Even if they survive, young mothers and their babies face enormous health risks. When a young woman's body is not physically mature enough to deliver a baby safely, obstructed labor is common, and can result in painful disabilities. Babies born to teen mothers are more likely to be premature and low birth weight. And young girls are at greater risk of contracting HIV/AIDS than boys their own age, which puts their babies at risk of being born with the disease. Although abortion could solve the problem but there is big price to pay that is postabortion health complications and future health and emotional risks.

Therefore, if not acted fast, problems will multiply manifolds!

Worldwide, 61 per cent of all women of reproductive age who are married or in a consensual union are using contraception. This percentage amounts to 635 million of the more than 1 billion women aged 15-49 who are married or in union. In the more developed regions, 69 per cent of those women use a method of contraception, while in the less developed regions 59 per cent do. In Africa, the corresponding percentage is a low 27 per cent, whereas in Asia and Latin America and the Caribbean the equivalent proportions are much higher, at 64 per cent and 71 per cent, respectively. In cases where contraception measures fails or unplanned, unwanted and un-welcomed forced pregnancy is aborted which carries serious risks. Sometimes women will bleed heavily during an abortion or a few days afterwards. Occasionally it is necessary to give a transfusion to replace the lost blood. Sometimes it is necessary to do a second curettage procedure or hysterectomy to stop the bleeding.

A uterus is susceptible to infection right after an abortion. Infections are even more of a risk if person have Chlamydia or Gonorrhea. Symptoms are pain and fever. This is generally treated with antibiotics but sometimes another curettage procedure must be used. If untreated, a very serious infection can develop and could result in infertility. Sometimes the tools of abortion are accidentally pushed through the wall of the uterus during an abortion. If the instrument damages one of internal organs, it may be necessary to do major surgery to repair the damage.

Severe injury to the cervix may occur «nd may result in the early loss of a later wanted pregnancy. The risk of miscarriage in later pregnancies is higher if a woman has had two or more abortions. The fetus may be growing in your fallopian tube rather than in your uterus. An abortion procedure would miss this and the continued growth of the fetus in your tube is dangerous.

When abortion is done after the first three months of pregnancy, the risk of death is increases. The cause of death by abortion is usually from heavy bleeding or from complications with anesthesia (the drugs used to help relieve pain).

Many women have an abortion out of fear and desperation. The woman considering her decision. "I let other people take charge of my life because I felt out of control". That abortion .is Ά woman's "choice" is in many cases questionable. .Many who come for help afterwards, express the sense they ultimately felt they had little or no choice, when weighing up the stresses and anticipated losses for them in their relationships and life.

Many women have developed a self-identity that simply does not include being a mother, and some hold to their right to regulate reproduction so strongly that the sudden intrusion of motherhood is often perceived as a complete loss of control over their present and future selves, and this can paralyze their ability to think more rationally and realistically. Abortion then becomes a matter of self-preservation.

The terrible miscalculation of women is that abortion can make them "un-j>regnant", that it will restore them to who they were before the crisis. But a woman is never the same once she is pregnant, whether the child is kept, adopted or aborted. Abortion may be a kind of resolution, but it is usually not the one -the woman most deeply longs for, nor will it even preserve her sense of self.

Studies point out that the -risk of an ectopic or tubal (not in the uterus but ill the tubes that lead to the uterus) pregnancy is 30% higher for women who have had one abortion, and up to four times higher for women with two or more abortions.

When a woman has an Ectopic pregnancy she has a 12% risk of dying in a future pregnancy. 5% of women suffer PID (Pelvic Inflammation Disease) following induced {or surgical) abortion. PID can lead to fever and infertility (not being able to get pregnant again). There is a 23% higher risk of infection if you have an STD (Sexually Transmitted Reputable studies suggest that women who abort face a 50% increase in breast cancer. If the woman .has a .family history of breast cancer, this rate doubles with each successive abortion. Placenta previa is a condition in pregnancy where the sac holding the baby (the placenta) tears away from the uterine lining. This can result in extreme and severe life- threatening bleeding. Women who have experienced abortion have a 600% increase in their risk for placenta previa in future pregnancies.

Infertility and sterility mean that a woman cannot get pregnant. Abortion causes sterility in 2-5% of the women who have an abortion. 50% of women who have had abortions report experiencing emotional and psychological problems lasting for months or years. These emotions include, but aren't limited to: acute feeling of grief, depression, anger, fear of disclosure, preoccupation with babies or getting pregnant again, nightmares, sexual dysfunction, termination of relationships, emotional coldness, increased alcohol and drug abuse, eating disorders and anxiety.

Many of these women go on to report that they regret their choice and would do anything to go back and undo the decision that resulted in so much pain. Therefore, it is better to use contraception to avoid unwanted pregnancy in the first place and also to avoid any risk of abortion and its related complications.

Choosing the appropriate contraceptive varies from individual to individual. Contraceptive options for women in developed countries include: hormonal contraceptives (oral contraceptives, implants, and injections); the intrauterine device (IUD); barrier devices with or without spermicides (diaphragm, cervical cap, female condom); natural family planning methods; and female sterilization (tubal ligation). Hormonal contraceptives use either a combination of estrogen (usually in the form of the compound estradiol) and progestin, or progestin alone. They are used in many forms: pill form; progestin-releasing IUDs; injections (e.g., Depo-Provera, a progestin injection; or

Lunelle, a combination of progestin and estrogen); implants (e.g., Norplant system etc.); skin patches (e.g., Ortho Evra); and vaginal Tings (NuvaRing).

Oral contraception, or the Pill, is used today by over 80 million women in the world, making it the third most popular method of family planning after female sterilization (210 million users) and intrauterine devices (156 million). The Pill is a tablet containing synthetic hormones and taken on a daily basis. When absorbed into a woman's bloodstream it prevents the release of the egg from the ovary, thickens cervical mucous, which hinders the passage of sperm, and thins the lining of the uterus which minimizes the chances of fertilization. The freedom the Pill gives has been of enormous psychological benefit to women since the 1960's. The pill is available in most countries throughout the world, and can be purchased on-line using Internet. Even without understating of its lethal side-effects.

The combined Pill contains synthetic forms of the hormones estrogen and progestogen which interfere with the woman's regular 28 day menstrual cycle. When the Pill keeps the hormone level artificially constant, the signal to ovulate is canceled out. Between them, the two hormones stop from getting pregnant. The main way in which they do this is by stopping ovaries from releasing an egg (ovulating) each month. Oral contraceptives should be taken each day at approximately the same time for maximum effectiveness. If the pill is forgotten one day it should be taken as soon as remembered and the normal routine resumed. For two days in a row take two the day remembered and two the next. If the pill is taken more than 12 hours late at any point during the cycle another form of contraception must be used or intercourse avoided for the remainder of the cycle.

Contraceptive pills carry serious side-effects. For those women who starting the pill before 20-yrs old, the risk of developing breast cancer was 820% higher than for healthy non-users of the same age. For women who starting pill between 20-25 years, relative risk was 180% higher than healthy non-users. Other researchers cite the risk of breast cancer for young womerifless than 20 yrs old) is 200-480% higher than for non-pill users. Even 3 months use of the pill has been reported to be associated with 100% increase in breast cancer and for more than ten years use, breast cancer risk increased by 310%.

Women with breast cancer, who at an early age have used oral contraceptives, have larger breast tumors and a worst prognosis compared with later (pill users) and never uses. Death rate from breast cancer in Australia is 20.4/100,000, in USA it is 20.7/100,000 and in Japan it is 7.1/100,000.

With the use of Depo-Provera contraceptive injection (DMPA) for two years or longer before age 25 was associated with a significantly increased risk of breast cancer for ovef 360%.

One research study concluded that contraceptive pill use in women less than 20-years old means 280% higher risk of cervical cancer and in women of 20-24 years of age, its 70 % higher and in women 25-29 years its 40% higher. Another study cites increased risk of 250% for cervical cancer amongst pill users. However, one of these studies showed women who used the pill for only 1-6 months had a 190% increase in cervical cancer than non- users. Clinical evidence cites the pill's role in activation of and enhancing HPV (Human Papillomavirus) in initiation of cervical cancer.

Risk of Deep Vein Thrombosis DVT increased by 600-900% (5-8 fold) compared to non- users in users of 3rd generation progestagen pills (eg containing gestodene eg Femodene, Minulet, Tri-minulet, or containing desogestrel eg Marvelon). Across all age groups, use of the 3rd generation pill brands had a 770% greater DVT risk than non-pill users. Second generation progestagens such as levonorgestrel and norethisterone liave 120-280% increase risk of DVT.

For teenagers aged 15-19yrs risk of DVT for the desogestrel-containing oral contraceptive was 7-fold higher than that of the levo-norgestrel containing products; among women aged 20-24 the risk was 4-fold higher". A 5ϋ fold increased risk of DVT for users carrying a blood clotting factor. This occurs in 5-15% of European women. Because gestodene causes to decrease oestrogen metabolism in liver leading to accumulation in body leading to increased DVT risk.

Another serious side-effect however is where women may not conceive for up to 48 months or longer depending on age. This is due to atrophy of the mucus secreting glands thus preventing sperm transport. Birth defects/chromosomal abnormalities in children conceived right after pill cessation.

Methotrexate - (given prior to 8 weeks) Doctors don't like to prescribe this chemical because of its high toxicity and unpredictable side effects. Those side effects include but are not limited to: nausea, pain, diarrhea, bone marrow depression, anemia, liver damage, lung disease, heavy bleeding for as long as 40 days and abortion may occur anywhere. In case if this chemical does not work, a surgical abortion may still be .required.

In addition to the risks stated above, women having chemical abortions (pill) often see the complete tiny bodies of their unborn -child and are even able to see the child's developing hands, eyes, etc. So traumatic is this for some women that it is recommended that women unprepared for the experience not to take the drugs.

Family planning reduces maternal mortality and improves women's health by preventing unwanted and high-risk pregnancies and reducing the need for unsafe abortions. Female sterilization, also called tubal occlusion or ligation, is a permanent contraceptive method for women who do not want more children. The concentration on female sterilization raises troubling concerns, since it is a more complicated and riskier operation. While arguments rage over the ethics of sterilization method, this does not prevent their widespread use by women all over the world.

Risks of female Sterilization has been well reported which include, mortality, bowel injury, vascular injury, Sterilization failures, pain, infection/hemorrhage and visceral (bowel, bladder, uterus) injuries. Many of the symptoms of PTS are associated with having an estrogen/progesterone imbalance. Other symptoms, such has heavy painful periods may be caused by a hormonal imbalance, could be caused by adenomyosis (bought on by uterus mussel and tissue being damaged, effected by the Tubal Ligation surgery impairing the blood supply to areas of that organ/mussel) or a combination of both. Other theories of PST and the hormonal imbalance that results after a Tubal Ligation is that "target" or "receptor" cells that are important in the relay of hormonal messages are damaged, destroyed, and or removed during the Tubal Ligation surgery. It is derivable that these target or receptor cells are located within the fallopian tube. Although there is quite a long list of sterilization side- effects, some of serious side-effects include:

Eptopic pregnancy (welll known risk of tubals); Hot flashes, flushes, night sweats and/or cold flashes, clammy feeling, chills; Bouts of rapid heart beat; Mood swings, sudden tears;

Irregular periods; shorter, lighter periods; heavier periods, flooding; phantom periods, shorter cycles, longer cycles; Loss of libido; Anxiety; Feelings of dread, apprehension;

Decrease in breast mass; Hair loss or thinning, head, pubic, or whole body; increase in facial hair etc. These side effects have been proven through clinical research and studies, and have been reported by health professionals and victims who have witnessed and experienced side effects first hand.

Similar to women sterilization, many men also chooses vasectomy for permanent non-drag contraception. A vasectomy involves cutting and tying the cord (the vas deferens) that carries the sperm to achieve permanent contraception. There are several procedures used to carry out a vasectomy. These involve either cutting or tying, electro-cautery (buring with an electrical current), or both. After the surgery, a blow out may occur if the severed cord swells and reopens under pressure from the sperm. Cutting the cord which carries sperm has an obvious danger. The sperm, which must go some where, may leak into the body cavities. The body will react to the out-of-place sperm with an immune response, thus opening the door for many complications. After a vasectomy, sperm production remains the same: about 50,000 spermatozoa each minute. Having "no way out" these cells are either consumed by the body's degenerate producing antigens or "foreign substances". These antigens infiltrate the bloodstream and cause the body to manufacture antibodies to defend itself against them. The disorders that are linked with auto-immune reaction after vasectomy include unexplained thrombophlebitis, prolonged fever generalized lymph node enlargment, recurrent infection, skin eruption, multiple sclerosis, liver dysfunction, and rheumatoid arthritis. In addition to these health problems, several studies have revealed a statistically significant association between the risk of prostate cancer and a history of vasectomy. The risk of prostate cancer in men who have had a vasectomy is more than that three times that of those who were not vasectomiezed.

Psychological disturbances occur immediately or many years after vasectomy. One study which tested patients before and one year after surgery indicated that over 40 percent of vasectomized men experienced personality problems as a result of the vasectomy. These psychological consequences may include the following, feeling of "stripped masculinity," marital difficulties, attitude of rejecting children, and envy of other people's children and the ability to have them. Aside from the side-effects caused from altering bodies from God- given functions, what is truly wrong with these procedures is that permanent damage is purposely done to bodies! Bodies that rightfully belong to God. Surgical methods of birth control should always be considered permanent. Even though reversals can be performed, they are very, very costly (up to 10 to 20 times the cost of having the surgery done in the first place), and the results are not guaranteed, especially if it has been more than 5 years since the surgery.

According to UNDP/UNFPAAVHOAVorld Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), all the evidence that has accumulated over the 30-40 years that contraceptive implants have been in existence indicates that they constitute better forms of contraception compare to other avaiable forms that exist. Once in place, women can forget about contraception for anything up to five years or more, depending on the type of device they use. But, no contraceptive is perfect and safe, inevitably, even with implants there is a price to pay — two prices, in fact: vaginal bleeding problems and various side-effects and substantial limitations. These drawbacks notwithstanding, the popularity of implants is rising rapidly: to date more than 11 million women around the world have used them and the number is expected to grow not because of they are good instead as of today no better alternative exist today which could address and solve the issues in taltality across all age-group females and yet acceptable across all relegion and socio-economic group.

As stated, vaginal bleeding are almost inevitable in users of hormonal or drug contraceptive implants. They are more common in the first months of use and tend to diminish over time. Many women experience prolonged or irregular bleeding or both during the first year of Norplant and Jadelle use. Although in subsequent years, bleeding patterns tend to improve, but prolonged amenorrhoea is infrequent. With Implanon, more than half of users experience amenorrhoea and infrequent bleeding, whereas prolonged bleeding is less common.

Headache is experienced by 10-30% of implant users. Comparative studies of contraceptive implant and non-hormonal methods of contraception have found two-to-three- fold higher rates of headache among contraceptive implant users. Less than 5% of women discontinue implant use because of this complaint, irrespective of the type of implant. Between 4% and 22% of implant users report a weight gain of 0.4-1.5 kg per year, but discontinuation rates are less than 4% for this problem. Acne has also been reported by 3— 22 % of users of any implantable contraceptive, while hair loss and hirsutism are less frequent complaints. The data suggest an association between skin and hair problems and the use of progestogen implants.

Between 4% and 11% of users of any implantable contraceptive complain at some time of dizziness but removal rates are low (0-2.3%) for this complaint. Mood changes, including nervousness and depression, are commonly mentioned side-effects of implants (in 1-9% of users). They account for less than 2% of removals, whatever the implant. Persistent follicles

Continuous low-dose progestogens, as delivered through implants, do not completely suppress ovarian function. Dominant follicles may sometimes develop, but the normal ovulatory process is frequently disrupted and follicle rupture does not occur. These follicular structures can persist and become enlarged (to over 30 mm).

Men represent half the world's population, but account for less than one-third of contraceptive use because they are not satisfied with current methods of male Contraception. The goal of practicing contraception varies from postponing childbearing, spacing births and limiting family size to absolute freedom from childbearing. Contraceptive needs of couples vary according to their type of relationship, purpose of contraception and age. Currently available methods of fertility regulation for men and women do not adequately meet the varied and changing personal needs of couples in their reproductive lives and in the widely different geographical, cultural, religious and service delivery settings around the world. While increasing the choice available to either partner will ensure the wider availability of safe and effective means for fertility regulation, the shortcomings of currently available male methods are a major barrier to the greater involvement of men in family planning. The availability and use of acceptable male contraceptive methods would reduce the burden traditionally placed almost exclusively on the female partner. Both men and women need the highly-effective Contraception without any side-effect to prevent unintended pregnancies and achieve healthy, intended births. A study found that 65% of women surveyed want men to play a greater role in choosing a method of contraception, and 75% want men to play a greater role in ensuring contraception is always used.

The majority of birth control methods tend to focus on the female body. But contraceptive choices available to men as of today is very limited and currently confined to only three contraceptive methods for male which include - withdrawal, the condom, and vasectomy (male sterilization). Although male-pill, male Vaccines, male-injection and male-spermicide contraceptives are still in the lab and testing, however, their side-effects could be even more dangerous as in the case of similar female contraceptive choices, where side-effects has been widely reported and documented. Drug-based contraceptive methods also cause infertility and sometime difficult to reverse or take long time to reverse fertility. Men are waiting for something more convenient than condoms, abstinence or a vasectomy or even those drugs in the lab test.

A World Health Organization study found that 45 to 75 percent of men would welcome a safe, reversible, convenient non-surgical male contraceptive which could be used separately from intercourse (World Health Organization). Clearly, such changes would have an enormous impact on worldwide male contraceptive patterns. New Research Data proves that men are significantly less satisfied with the male condom and withdrawal. AU types of single use temporary contraception methods have Highest Failure rate. Although using condoms can protect against STIs; however, condom use declines with men's increased age, largely because older men are more likely than younger men to be in an established relationship; in either case, men don't like them.

It is therefore there is an acute need to develop drug-free implant, which not only address problems of currently all available contraceptive drugs and implants but also to address all contraceptive related problems of other contraceptive alternative options and yet reversible at any time and can be used by men and women across all age-groups specially teen-age girls and breast-feeding mothers.

Human reproduction hinges on female ovulation. Whereas the male produces sperm on a daily basis, women ovulate only once during a particular ovulation cycle. It is only during this relatively short time period (the ovulated egg must be fertilized within 12 hours or at most 24 hours or it will die) that successful conception may occur. The ensuing two weeks are spent waiting and wondering whether implantation has or has not been successful. It is for this reason that pregnancy success rates according to the probability that conception will occur during any one "cycle". Therefore accurately predicting, controlling and managing ovulation time will be the bottom line achieving both contraception and conception goals.

According to the World Health Organisation (WHO), about 15% of couples of childbearing age seek medical help for infertility, usually after about two years of failing to conceive and the rate of infertility is increasing with the growing trend for couples to delay starting a family (using drug-based contraception) until their mid-30s. In approximately 40% of infertility, the failure to conceive is attributable to a problem affecting the woman. In 25% of couples the problem lies with the man, while in a further 25% of couples factors in both partners contribute to the problem and 10% are unexplained. Consequently, the treatment of both partners must be coordinated and good communication between the urologist and the gynecologist is paramount.

WHO believes that there are around 80 to 100 million infertile couples in the world. Now, whilst this may come as no real consolation (but may help put the situation in some context) - becoming pregnant and going to be a father is not that easy, even for people who do not have fertility problems! It's a little known fact that humans are one of the least fertile creatures on earth. There is only a fairly short time within the menstrual cycle when conception is possible, making the chances of conception only 25% each month. It is estimated that 10% of normally fertile couples fail to conceive within their first year of attempt and 5% after two years. Between 2 and 10% of couples worldwide are unable to conceive a child and a further 10 - 25% experience secondary infertility, in other words, they are unable to conceive a second or subsequent child.

In vitro fertilization and embryo transfer involves the harvesting of several oocytes (eggs) from the stimulated ovaries. This process allows the direct fertilization of the oocytes with sperm. The pre-embryo(s) thus formed can then be transferred into the womb at the right time. The IVF (in- vitro fertilization) procedure is considered by some, to be one of the most stressful infertility treatments. This is because only 1 of 10 embryos will become a baby. With such a high failure of treatment can result in emotional strain, psychological stress and depression. Some couples may require psychological counseling. In addition, couples may encounter physiological difficulties when multiple pregnancy and birth defects occurs.

There is no drug that is absolutely safe and completely free of side effects. The fertility drugs that stimulate ovulation are rarely associated with complications. There are potential problems, which may occur and include: side effects of fertility drugs, ovarian hyperstimulation syndrome (OHSS), multiple pregnancy, adnexal torsion (ovarian twisting) and the risk of ovarian cancer. As with any surgical procedure, there are potential risks associated with egg collection. Egg retrievel surgical procedure may causes injuries to internal organs such as bowels, bladder or blood vessels during the procedure. This is an extremely rare complication. Ectopic pregnancy is a potentially life threatening condition. Ectopic pregnancy is a well-known complication of assisted IVF related conception treatments. A relatively new but now common technique called ICSI₅ in which a single sperm is injected directly into an egg, virtually any man can now become a biological father, no matter how weak or slow or scarce or chromosomally problematic his sperm. Increasingly, doctors suspect that ICSI may interfere with imprinting — the switching on and off of genes in the early days of embryonic development — possibly leading to genetic syndromes like Beckwith- Wiedemann. If nothing else, ICSI clearly is enabling infertile men to produce infertile sons. "We're creating a whole new generation of patients," acknowledged one doctor.

One of the major problems with IVF today is the low pregnancy rate after successful embryo transfer. The reason why such few embryos implant successfully (only 1 of 10 embryos will become a baby) is one of the things we really do not understand today. Probably the ingredients and procedure could be very wrong. It is further believes that this is because the surrounding shell of the embryo (called the zona pellucida) hardens when it is cultured in the laboratory. They therefore use "embryo surgery" called zona drilling or assisted hatching to "soften" the shell of the embryo, and they believe this helps to increase pregnancy rates by improving implantation rates, since embryo hatching is facilitated. This can be done using an acid (acid Tyrode's) or with a laser. A group of Swedish scientists published one of the most comprehensive study on neurological disorders in IVF children. The Swedish group identified 138 distinct disorders and grouped them in 20 categories. These include mental retardation, infantile autism, behavioral disorders, speech disorders, suspected developmental delay, cerebral palsy, congenital malformations, chromosomal aberrations, neuromuscular disorders, torticollis, brachial plexus injury, disorder of the joints, disorders of the eye, hearing loss, hydrocephalus, habitual tip-toeing, accidents, seizures, other neurological disorders, and other disorders Among the most common diagnoses were cerebral palsy, suspected developmental delay, congenital malformation, mental retardation, chromosomal aberration, and behavioral disorders. IVF children face a risk of cerebral palsy that is almost four times higher and a risk of congenital malformations that is almost twice as larger than in children conceived naturally.

These rather disturbing results can partly be explained by the large incidence of twins and higher order pregnancies and associated problems, in particular low gestational age and low birth weight. For IVF singletons, the risk of cerebral palsy is nearly three times higher and the risk of congenital malformations remains twice that of the control population. Because of this, a number of European countries have mandated a one-embryo-transfer policy.

Instead of reversing fallopian tubes defects or problems, an artificial fertilization in the lab brings more serious disorders and challenges than it does little good. It is therefore important to find ways to not only overcome and reverse the fallopian tubes problems and defects but also to provide assistance for natural fertilization within fallopian tube. The menstrual cycle is the periodic change in a woman's body that occurs every month between puberty and menopause and that relates to reproduction. The average human menstrual cycle, regulated by hormones, takes 28 days, but it can range from 21 to 35 days.

Menstruation, commonly called a woman's period, is the approximately monthly shedding of the lining of the uterus; the blood and tissues that have built up throughout the month preparing for fertilization leave the body through the vagina. This bleeding, which can last from 2 to 7 days, usually indicates that conception has not taken place and that the menstruating woman has not become pregnant. The discharged material variously bears the name of menses or (rarely) of menstruum (plural: menstrua). Menstruation forms a normal part of a natural cyclic process occurring in all healthy adult women between puberty and menopause. Regular menstruation normally begins (menarche) between the ages of 8 and

18; menopause normally occurs between the ages of 40 and 60.

By convention, the onset of menstrual bleeding (menstruation or menses) marks the beginning of the cycle. (Actually, menstruation marks the end of the cycle and ovulation or ripening of an egg the beginning). Menstruation lasts for several days and involves the loss of the lining of the uterus. The uterus prior to menstruation had prepared to accept a fertilized egg (ovum), but if none arrived, and so the uterus expels its lining (called endometrium). Therefore, if menstrual bleeding occurs, a woman knows that she is not pregnant.

Then a new egg matures in the ovaries, and about at the middle of the cycle, ovulation occurs, meaning that the ovary releases an egg, which enters the fallopian tube. In some women, ovulation features a characteristic pain called Mittelschmerz which lasts for several hours. A characteristic clear and stringy mucus develops at the cervix, ready to accept sperm. The egg (with a diameter of about 0.1 to 0.5 mm) travels through the fallopian tube to the uterus, pushed along by movements of the lining of the tube.

Sperm can survive for 2 to 3 days inside a woman, so the most fertile period (the time with the highest likelihood of sexual intercourse leading to pregnancy) covers the time from some 5 days before ovulation until 1 to 2 days after ovulation.

After passing the uterus, sperm cells enter the fallopian tubes. Once inside a tube, they attach themselves to the tube's wall and pause for "storage," during which they go through a maturation process that prepares them for penetrating the egg. A sperm cell that has completed this maturation process detaches itself from the wall and leaves the storage site. If ovulation had taken place in the preceding 24 hours, releasing an egg ready to be fertilized, the mature sperm would embark on a long, complicated journey through the tube to the site of potential fertilization.

In the meantime, the endometrium has started to grow again. If fertilization occurs, the egg implants itself in the wall of the uterus and the major changes of pregnancy commence, including the suspension of the menstrual cycle for the duration of the pregnancy. If, on the other hand, no fertilization occurs, the endometrium is lost with bleeding, and the cycle starts again.

Menstruation involves the loss of about 50 millilitres of blood. An enzyme called plasmin - - contained in the endometrium — inhibits the blood from clotting. Because of the blood loss of menstruation, women have higher dietary requirements for iron than males in order to In most women, various unpleasant symptoms caused by the involved hormones and by cramping of the uterus precede or accompany menstruation, Such symptoms include abdominal pain, migraine headaches, depression and irritability. All of a woman's ova exist in the ovaries at the time of her birth; an estimated 250,000 to 400,000 immature eggs reside in each ovary. On average 450 of them develop into mature reproductive cells during a lifetime.

In a normal four-week cycle, this corresponds to the second and the beginning of the third week of the cycle. Various natural family planning methods of birth control attempt to determine the precise time of ovulation are flaws in order to find the relatively fertile and the relatively infertile days in the cycle. In the past, it is discovered that the egg "calls upon" the mature sperm by releasing a chemical substance. However, the chemical signal can attract the sperm only across a short range: since the tube normally moves in a wavelike fashion, the chemical apparently cannot not spread effectively through the entire tube, and therefore cannot dispatch a signal to the sperm over longer distances. Therefore, the chemical attraction, known as "chemotaxis," cannot account for the sperm's entire journey.

People who have heard about the menstrual cycle and ovulation may commonly and mistakenly assume, for contraceptive purposes, that mentrual cycles always take a regular

28 days, and that ovulation always occurs 14 days after beginning of the menses. This assumption may lead to unintended pregnancies and prooven failed as contraceptive measure.

The importance of predicting human ovulation for either optimizing conception or avoiding conception has been considered from an endocrine, morphological and clinical view point. Of the biochemical markers in peripheral blood, the knowledge of the LH hormone peak is the most clearly defined, with a two to four fold increase above baseline levels for a relatively short 24-30 hour preovulatory period. Ovulation is considered to occur 28-36 hours after the beginning of the LH rise or 8-20 hours after the LH peak. Daily assessment of the rise in preovular estrogen reflects Graafian follicle development but the rise is less distinct and spread over 3-4 days with marked day to day fluctuations. LH hormone induces a marked reduction in estrogen production some 12 hours prior to ovulation and at the same time induces a two to three fold increase in progesterone production above baseline levels. While these changes in themselves are not great enough for day to day discrimination, instead they should be taken or noted 2 to 3 times per day with multiple factors (specimens).

The preovular rise in FSH hormone is relatively small compared to LH hormone and the radioimmunoassay technique has not generally been refined to be as rapid and reliable. Monitoring the day to day growth of the preovular follicle ultrasonically is both linear and potentially predictable but there is a wide range of its final diameter (17-26 mm) prior to ovulation making prediction inaccurate. Percutaniously, the knowledge of menstrual cycle length in association with verious electrolytes, enzymes and body temperature changes which herald ovulation and conception are useful and may forewarn that ovulation in terms of days or hours is approaching. The knowledge of the basal body temperature is not a prospective guide to ovulation and also a serious flaw because it has to be taken in an "extreme" precise way, but once the thermal shift is established in association with loss of periovular mucus symptoms, the fertile period can be considered to have passed.

Sperm use heat sensors to find the egg in fallopian tube much like guided missiles that sense the heat of a plane's engine similarly sperms are also guided to the fertilization site by temperature sensation. To test this theory, the scientists built a lab installation simulating the storage site, the fertilization site, and the tube in between. They tested the behavior of sperm in this system and found that the sperm were indeed sensitive to heat: they were attracted from the relatively cool area, with the temperature of 37° C (98.6° F), to the relatively warm area, with the temperature of 39° C (102.2° F). When the scientists gradually reduced the difference in temperature, they found that even a half a degree difference was enough to attract the sperm. Moreover, the researchers found that only the mature sperm, the ones likely to penetrate the egg, acted as heat-guided missiles and were affected by the temperature difference. Therefore, if one is stating that "Temperature" changes only after egg fertilization or passed-away, is wrong.

Therefore it is very important to measure the specimen/s right at the place where very important events are being taking place as in the case of the present invention.

Because there is no easy, precise and simple marker of human ovulation, it is necessary that the most suitable marker of pre- or post-ovulation is chosen for the particular need in a given individual. Therefore it is very important to measure correct ovulation time in advance and to determine the successful conception and the health of ongoing pregnancy. The reason to determine or monitoring the health of pregnancy is that if anything goes wrong during the course of conception and ongoing pregnancy, it could be life threatening specially due to rupture of fallopian tube. Therefore it is also important to monitor pregnancy before it is too late.

Ectopic pregnancy occurs at a rate of 19.7 cases per 1,000 pregnancies in North America and is a leading cause of maternal mortality in the first trimester. Greater awareness and measuring important parameters of risk factors and improved technology can help ectopic pregnancy to be identified before the development of life-threatening events. After a careful history and physical examination, studies may include a urine pregnancy test and determination of the serum progesterone level, electrolytes, temperatures and serum quantitative β-hCG levels. However, these tests require to be tested multiple times and consecutively spanning over few days and weeks otherwise difficult to determine on the spot if it is in early stage of pregnancy except to take an invasive or ultrasonic examination. Therefore it is also important to monitor pregancy on a continuos bases than merely on monthly or biomonhly basis before it is too late.

Contraception, conception and on going health of pregnancy requires clear understanding of two main hormones that have involvements: estrogen (estradiol) and progesterone along with various temperature rise and fall, electrolytes, enzymes, protiens and Chorionic gonadtrophin. At the beginning of the menstrual cycle, the pituitary gland releases follicle stimulating hormone (FSH), signaling to the immature follicles to grow in the ovaries. (The follicle consists of a sac containing the egg.) Normally a woman's body will produce only one egg per period. Which gonad ovulates is essentially random; there is no left/right coordination involved. The first follicle to develop secretes inhibin, which shuts off the FSH, preventing more follicles from developing. Oestrogen levels rise as the developing follicle secretes that hormone. During ovulation, the follicle and the ovary's wall burst, releasing the egg; oestrogen levels peak at this time.

After ovulation the corpus luteum — which develops from the burst follicle and remains in the ovary — secretes both oestrogen and progesterone. Progesterone has the function of preparing the body for the possible pregnancy. If no pregnacy occurs, the corpus luteum dies and hormone levels fall, which causes the ejection of the endometrium with menstruation.

If pregnancy occurs, the placenta produces hormones to suspend the menstrual cycle — Chorionic gonadtrophin to maintain the corpus luteum, and Inhibin to prevent further ovulation — in addition to oestrogen and progesterone.

This is the reason oestrogen and progesterone are also the main ingredients of most birth control pills. Therefore, in order to predict pre, post and ongoing pregancy, it is important to measure them either directly or indirectly with associated changes in fluids, temperature and other means of electrical changes of the body.

Most consider "estrogen" as if it were a single hormone. The fact is, estrogen consist of three different hormones - estrone, estradiol and estriol. These hormones are produces by the ovaries and to some extent by the adrenal glands. The levels of these hormones in a healthy menstruating woman are as follows: Estrone 5 to 10%; Estradiol 5 to 10%; and Estriol 80 to 90%.

The exact ratio varies depending on the time of the menstrual cycle, but the level of estriol is always 8 to 9 times higher than that of either estrone or estradiol.

Out of the 3 estrogens, the estradiol is by far the most potent. It is primarily responsible for the "estrogenic" effects, both positive and negative. Estriol is a weak estrogen. Its main function appears to be to counteract the effects of estradiol. It is considered "protective" and "anti-cancerogenic", which is the reason why its level is so high. The The main function of estrogen is to prepare the body for pregnancy. As a result, estrogen leads to increased proliferation of endometrium (lining of the uterus); stimulation of breast growth; increased fat production and reduced metabolism; salt and fluid retention; reduced activity of thyroid hormone; depression and headaches; increased blood clotting; decreases libido; impaired blood sugar control; reduced oxygen levels in all cells; increased risk of endometrial cancer and increased risk of breast cancer. Therefore any contraceptive attempt to suppress or modify Estrogen (Estradial) hormone is a not only a serious rather a fatal attempt.

Estradiol is the most potent estrogen of a group of endogenous estrogen steroids which includes estrone and estriol. In women estradiol is responsible for growth of the breast and reproductive epithelia, maturation of long bones and development of the secondary sexual characteristics. Estradiol is produced mainly by the ovaries with secondary production by the adrenal glands and conversion of steroid precursors into estrogens in fat tissue.

During the early part of the menstrual cycle, estradiol levels remain nearly constant. This is followed by a rapid increase reaching a peak the day before or the day of the Leutinizing Hormone (LH) surge (ovulation). It is generally believed that the rise in estradiol is the factor which triggers LH release instead of estrogen in the whole. Following ovulation there is a drop in estradiol followed by a second rise which corresponds with the formation of the corpus luteum.

At menopause, estrogen concentrations in the body fall to low levels. This decrease is often accompanied by vascular instability (hot flashes and night sweats), a rise in incidence of heart disease, and an increasing rate of bone loss (osteoporosis). Estrogen replacement for alleviation of menopausal symptoms or to prophylax against heart disease and osteoporosis has become very common.

Estradiol levels are used to assess fertility, amenorrhea and precocious puberty in girls. Measurement of estrogen levels is also useful to monitor and titrate replacement therapy especially when the endpoints are long term health (reduction in heart disease and osteoporosis) rather than the immediate relief of symptoms.

These discussions clear various misunderstandings. However, despite acute need for contraception and conception (pregnancy), one who is taking today's contraception alternatives carries serious health risks which can be fatal over a long period of time. This paves the way to find new solution in the present invention which does not alter natural cycle of female and male reproductive system. It has been further proved that any attempt to permanently disable one's fertility also carries long-term health risks including psychological, social and married life. However, on the other hand, complete abstention from healthy sexual life is also bad for the stable and healthier female and male life-cycle.

In short, preventing an unwanted pregnancy is the best course instead of taking any kind of abortion treatment which not only adds cost but carries serious health risks. And if no unplanned and unwanted pregnancy (fertilization) takes place, abortion is out of question. Similarly, if no medication is used to prevent pregnancy, risk of side effects including infertility will also vanish. Likewise, if no surgery is performed for sterilization, vasectomy and or abortion, the probability to become pregnant and fertile again is there without going through flawed process of artificial fertilization and its consequences and serious risks. And if the ovulation time and various hormonal and electrophysiological parameters are measured and predicted, there is clear probability to manage it well. In addition, if pregnancy is monitored continuously right at the beginning, the risk of life threatening fallopian tube rupture, miscarriage and other related complications can also be minimized and or even avoided.

Discussions on these just few inter-related subjects, like contraception, sterilization, vasectomy, infertility, pregnancy, ectopic pregnancy, abortion, miscarriage, ovulation, pre and post ovulation hormonal prediction and other specimens measurements etc., present Pandora of problems, shortcomings, limitations and wrong treatments in current methods, solutions and or treatment practices. Many of these challenges clearly demonstrate that if lumen path of male and or female's tubes, ducts, vessels , urethras, ureters and or conduits etc. is blocked, regulated, dilated, and or constricted partly, completely, or regulatory for continuous and or for a specific time or for repetitive cycles to alternate and or substitute lumen paths remotely, locally, and or automatically by using tubular implant of the present invention, all these problems can be solved and treated. Similarly, in situations where these lumen paths are blocked, cut, injured, scarred, plaqued, enlarged and or narrowed, the present invention would assist in reversing these conditions. When an implant carries such functionalities and designs, it can supplement many uncountable applications, benefits and treatments — erectile dysfunction, urinary incontinence, Benign Prostatic Hyperplasia (BPH) and bladder outlet obstruction (BOO) etc. are a just few to mention in addition to what has been stated above. FIELD OF THE INVENTION

This invention generally relates to methods and tubular implant device to act as an alternative to and or substitute for the lumen path for blocking, regulating, dilating, and or constricting partly, completely, or regulatory for continuous and or for a specific time or for repetitive cycles of male and or female's tubes, ducts, vessels, urethras, ureters and or any conduits etc. The control can be exercised by using remotely, locally, and or automatically the said Novel tubular implant device which may also be activated as a result of changes in values of specimens and or parameters where it is implanted and or driven by software program selection remotely or locally when meeting, exceeding, or lowering one or more specific conditions) and or predicting specific analysis of current and historical measurements criteria and or even on demand. The present invention also provides an alternative and or substitutive lumen path of tubes, ducts, vessels, urethras, ureters and or any conduits etc, for blocked, cut, injured, scarred, plaqued, enlarged and or narrowed tubes, ducts, vessels, urethras, ureters or any conduits etc. of male and or female for opening or grafting of various such lumens and or any fluid circulation paths including controlling and regulating their flow paths based on various measuring parameters thereof.

DESCRIPTION OF THE PRIOR ART

Although the background of the present invention as stated above underlines clear reasons for the present invention but more importantly describes beneath why prior art inventions are not that effective to address all problems and concerns. If one prior art invention solve one or more problems it also caused to initiate one or more other associated problems and limitations.

However, following paragraphs will explain some of just few prior art inventions and their limitations, shortcomings and problems specifically, while the other related prior arts will be negated and disassociated by itself from objectives and description of the present invention even without being discussed here.

U.S. Patent Application Publication No. 6,742,520, Wildemeersch; Dirk discloses the invention concerns an intrauterine device comprising a support 41, and constituents 42, 43 releasing an active ingredient. In accordance with the invention, the active ingredient is constituted by copper with a surface area of 100 to 250 mm.sup.2 and by a steroid from the progesterone family with a release rate in the range 10% to 70% of the minimum release rate employed for the steroid concerned when it is used as a contraceptive active ingredient. With the device of the invention, contraceptive efficacy is very high and side effects are substantially reduced.

U.S. Patent Application Publication No. 6,742,520, Wildemeersch; Dirk discloses himself that this patent carries side effects to some degree and it is also a continuous contraception and releasing active ingredient all the times. Earlier discussions and research finding (in the background of present invention) has proven that these active ingredients cause serious side effects particularly heavy menstrual bleeding and so on. Therefore lacks the effectiveness for good and safe contraception besides other limitations and shortcomings including not being able to be right for conception and at the same time does not have pre and post- ovulation, ovulation, conception and pregnancy monitoring health related predictions. Above all, it carries no possibility of user selection to choose contraception and conception, directly, automatically or even remotely.

U.S. Patent Application Publication No. 6,726,682, Harrington, et al. discloses the invention a device for sterilizing females by occluding the uterotubal junction. The device includes a catheter with a releasable heat generating plug which is used to thermally damage the uterotubal junction and cause it to constrict around the plug, after which the plug is released from the catheter and left in place in the uterotubal junction.

U.S. Patent Application Publication No. 6,726,682, Harrington, et al. discloses themselves that this patent carries seriously damage to the uterotubal junction thermally to achieve permanent and irreversible contraception. Without going in to the further detail of this invention it is not suitable for human use, which carries serious repercussions as stated and discussed earlier. While lacks the effectiveness for being a good and safe reversible contraception besides other limitations and shortcomings including not being able to be right for conception and at the same time does not have pre and post-ovulation, ovulation, conception and pregnancy monitoring health related predictions. Above all, it carries no possibility of user selection to choose contraception and conception, directly, automatically or even remotely. Therefore it can not be considered as a good solution. U.S. Patent Application Publication No. 6,709,667, Lowe, et al. discloses the invention for contraceptive methods, systems, and mechanical device generally improve the ease, speed, and reliability with which a contraceptive device can be deployed transcervically into an ostium of a fallopian tube. The contraceptive device may remain in a small profile configuration while a sheath is withdrawn proximally, and is thereafter expanded to a large profile configuration engaging the surrounding tissues, by manipulating one or more actuators of a proximal handle with a single hand. This leaves the other hand free to manipulate a hysteroscope, minimizing the number of health care professional required to deploy the contraceptive device. The described devices promote a tissue in-growth network to provide long term conception for permanent sterilization without the need for surgical procedures, and should avoid the risks of increased bleeding, pain, and infection associated with intrauterine devices.

U.S. Patent Application Publication No. 6,709,667, Lowe, et al. discloses themselves that this invention is a permanent method of contraception for a long term once tissue in-growth is complete. Although it is easier method compare to surgical procedure to laigate fallopian tubes and does not carry side-effects compare to those which releases some form of active or non-active ingredients or medications. However carries no benefit in terms of reversible procedure, because both surgical tubal laigation and this invention require extensive and risky surgical procedures. Above all, it carries no possibility of user selection to choose contraception and conception, directly, automatically or even remotely without the need of any surgical procedure. Invention also lacks in function to inform user of pre and post- ovulation, ovulation, conception and pregnancy monitoring health related predictions. Besides any removal, cut or damage or all causes to the human body internally or externally without a life threatening risk is seriously against almost all religions. Therefore it can not be considered as a good solution.

U.S. Patent Application Publication No. 6,357,443, Loy; Randall A. discloses the invention a removable fallopian tube mechanical plug includes an elongated shaft member that has a diameter dimensioned for insertion into a human fallopian tube. The shaft has an image-able portion located at each of a distal end and a proximal end. A plurality of flexible fingerlike protrusions are affixed to at least a portion of the shaft, and are movable between a first position generally adjacent the shaft and a second position extending radially outward therefrom. The protrusions are biased to the second position and are adapted for closely engaging the fallopian tube when in the second position, and they are further arrayed radially and axially so as to form a barrier sufficient to prevent a passage of an ovum or a spermatozoa in an axial direction. It further discloses that in order to reveres this continuous in nature contraception requires doctors or surgeon consultant to perform the removal of said invention device.

U.S. Patent Application Publication No. 6,357,443, Loy; Randall A. discloses himself that this invention is a continuous or permanent contraceptive device as long as it resides in the fallopian tubes. Although the invention (device) could be removed without surgery however require doctor or surgeon consultant to perform the removal which adds additional cost, discomfort and could be risky in a situation where procedure could accidentally damage fallopian tubes or uterus. This invention clearly lacks liberty and ease of choice where user could reverse the contraception by herself or himself automatically or even remotely without the need of expert help and intervention and could avoid all associated risks and complications and even without the need of removal of device (invention) itself. Invention also lacks in function to inform user of pre and post-ovulation, ovulation, conception and pregnancy monitoring health related predictions. Last but not least, once the device is removed there is no protection unless new device is implanted again which add additional cost, pain and risks. Therefore it can not be considered as a good solution. On the other hand, permanent blockage of fallopian tubes for several months unreasonably blocked fluid and secretion flow within the fallopian tube lumen which helps to maintain good lumen health of its lumen path and surrounding wall, and because of such permanent blockage damage the fallopian tube's lumen and wall which ultimately leads to infertility.

U.S. Patent Application Publication No. 6,145,505, Nikolchev, et al. discloses the invention is an electrically affixed transcervical fallopian tube occlusion device which provides intrafallopian occlusion using non-surgical methods for their placement to prevent conception. The efficacy of the device is enhanced by forming the structure at least in part from copper or a copper alloy. The device is anchored within the fallopian tube by imposing a secondary shape on a resilient structure, the secondary shape having a larger cross-section than the fallopian tube. The resilient structure is restrained in a straight configuration and transcervically inserted within the fallopian tube, where it is released. The resilient structure is then restrained by the walls of the fallopian tube, imposing anchoring forces as it tries to resume the secondary shape. The invention further claims and asserted that it permanently damage the surrounding tissues of fallopian tubes hence not reversible.

U.S. Patent Application Publication No 6,145,505, Nikolchev, et al. discloses themselves that this invention causes permanent damage to the surrounding tissues of fallopian tubes' lumen wall for fixing contraceptive device, hence contraception is permanent and irreversible rather more importantly causes damage to the living organs permanently therefore not suitable for human use. Without going in to the further detail, this invention also stands in line with previously stated inventions or invented anywhere in the world which are not well suited hence hold similar disadvantages as stated earlier and lacks several features and functions which are the prime principles and reasons of the present invention as described in objectives and description of the present invention. Besides any removal, cut or damage or all that causes to the human body internally or externally with or without a life threat risk is serious act against almost all religions. Therefore it can not be considered as a good solution.

U.S. Patent Application Publication No. 6,468,223, Kaga; Kamal discloses the invention an apparatus and method for monitoring, predicting and detecting ovulation during the menstrual cycle of a female subject is based upon daily changes in frequency of an oscillator circuit when a capacitive oral sensor is placed in contact with the subject's saliva.

An oral sensor that forms a component in the oscillator circuit contained in a hand-held, portable device includes a pre-programmed integrated circuit device with data processing and control capacities, data storage and display means for measuring, recording and processing historical baseline data and relative frequency changes within the subject's current menstrual cycle.

U.S. Patent Application Publication No. 6,468,223, Kaga; Kamal discloses that in-order to estimate the ovulation prediction user must do the specimen test in a very specific manner which means any mistake or if not following specific way of testing the accuracy of the ovulating prediction could be a flaw. Although the invention is good for its individual function but if considering the fact that only educated users could be benefit to it while the dire need of contraception are those who are either have no education or lacks the understanding to use the apparatus. While on the other hand, even if user know how to predict the ovulation is good, there is no guaranty of contraception or unwanted pregnancy because it is not the purpose of said invention to do the contraceptive measures. In order to get meaningful ovulating prediction, user has to make several attempts to do the testing manually in just a single day spanning throughout the prediction cycles over several days and may give feelings of being sick and un-comfort ness and even crazy. This explains itself, how difficult it is to do the just one single prediction of the menstrual ovulation. Furthermore, sensor could attract the harmful contamination or other forms of viruses and when inserted could be risky to user's health. This invention is dependent on non-invasive methods to do the ovulation prediction where as it is the objective of the present invention to do the invasive ovulation prediction and more importantly measures the specimens right at the place where changes are being taking place, instead of external (non-invasive) sliva, vaginal mucous or eccrine sweat etc. which are prone to be flawed because there are many factors that affects salvia and ecrin sweat reading for example, food intake, weather, physical activities, inappropriate sleep, anxiety and many such likes. Once the ovulation is predicted, it is also required to calculate the luteal phase to mark as safe-window without being pregnant. Almost all ovulation tests predict the earlier phase of the ovulation or the ovulation but do not determine the latter phase of the ovulation to mark the safety to avoid the fertilization and pregnancy. On the other hand, there is no automatic measurement of ovulation prediction (without manual measurements of saliva, ecrine, urine and or blood) by just a simple pressing of the button as in the present invention. Furthermore, this invention does not provide any prediction and monitoring to watch pregnancy. Therefore U.S. Patent Application Publication No. 6,468,223, by Kaga; Kamal lacks the integral part of total solution as proposed, presented and invented in the present invention. In addition, to our knowledge there is no such implant which monitors entire course of healthy and abnormal pregnancy to avoid serious life threatening risks. This is where present invention also stands high in its inventiveness.

U.S. Patent Application Publication No. 6,592,529, Marett; Douglas M. discloses the invention as a method and device to predict ovulation in a female human by measuring changes in the concentration of a number of ions in eccrine sweat is disclosed. The concentration or changes in concentration, of one or more ions are determined throughout the day and analyzed against predetermined patterns in order to predict ovulation one to five days in advance. This permits the user to more accurately determine commencement of the fertile phase, which for female humans is generally considered to be about four days prior to ovulation to one day after ovulation. The concentration of the ions measured include sodium (Na+), potassium (K+), ammonium (NH.sub.4 +), calcium (Ca.sub.2 +), chloride (Cl-) and nitrate (NO.sub.3 -). To further increase the accuracy of the reading, a large number of readings can be obtained throughout a day and statistically analyzed to determine the change over time. In addition, the concentration of two or more ions can be obtained to increase accuracy. Ratiometric measurements between two or more ions can be determined to increase accuracy and account for ion accumulation on the skin. Ratiometric measurements between ammonium (NH.sub.4 +) and calcium (Ca.sub.2 +) have been found to provide more distinct patterns because the concentrations of these two ions change in opposite directions during the relevant period preceding ovulation.

U.S. Patent Application Publication No. 6,592,529, Marett; Douglas M. discloses that in- order to estimate the ovulation prediction, the user must do the specimen test in a very specific manner which means any mistake or if not following specific way of testing the accuracy of the ovulating prediction could be a flaw. It is also noted that in colder climates where the user may excrete less eccrine sweat and therefore change in ionic properties of eccrine is unavoidable which ultimately affects the accuracy of the invention significantly. Although, the invention is good for its individual function but if considering the fact that only educated users could be benefit to it while the dire need of contraception are those who are either have no education or lacks the understanding to use the apparatus. While on the other hand, even if user know how to predict the ovulation, there is no guaranty of contraception or unwanted pregnancy because it is not the purpose of this invention to do the contraceptive measures. In order to get meaningful ovulating prediction, the user has to make several attempts to do the testing in just a single day spanning throughout the prediction cycle over several days. This explains itself, how difficult it is to do the just one single prediction of the menstrual ovulation. Furthermore, sensor could attract the harmful contamination or other forms of viruses and when contacted with the subject body could be risky to user's health. On the other hand, there is no automatic measurement of ovulation prediction (without manual measurements of ecrine) by just a simple pressing of the button as in the present invention. This invention is dependent on non-invasive methods to do the ovulation prediction where as it is the objective of the present invention to do the invasive ovulation prediction and more importantly measures the specimens right at the place where changes are being taking place instead of external (non-invasive) eccrine sweat etc. which are prone to be flawed because there are many factors that affects ecrin sweat reading for example, food intake, weather, physical activities, inappropriate sleep, anxiety and many such likes because there are hundreds of reasons which causes and presents changes to the external body. Once the ovulation is predicted, it is also required to calculate the luteal phase to mark as safe-window without being pregnant. Almost all ovulation tests predict the earlier phase of the ovulation but do not determine the latter phase of the ovulation to mark the safety to avoid the fertilization and pregnancy. Furthermore, this invention does not provide any prediction and monitoring to watch pregnancy. Therefore U.S. Patent Application Publication No. 6,592,529, Marett; Douglas M. lacks the integral part of total solution as proposed, presented and invented by the present invention. Furthermore, to our knowledge there is no such implant which monitors entire course of healthy and abnormal pregnancy to avoid serious life threatening risks. This is where present invention also stands high in its inventiveness.

In conclusion, the present invention is not only a "Novel" but it is also a "Superior" invention which takes holistic approach to solve all associated problems of contraception, conception and pregnancy, compare to all currently available methodologies, procedures, devices and therapies. And above all, it also monitors entire pregnancy to avoid life threatening risks.

OBJECTIVES OF THE PRESENT INVENTION

The principal objective of the present invention as tubular implant device is to provide an alternative to and or substitute for the lumen paths of male and or female's tubes, ducts, vessels, urethras, ureters and or any conduits etc. for blocking, regulating, dilating, and or constricting partly, completely, or regulatory for continuous and or for a specific time or for repetitive cycles to control lumen paths of male and or female's tubes, ducts, vessels, urethras, ureters and or any conduits etc.

It is also the objective of the present invention that the control and operation of the present invention (tubular implant) when blocking, regulating, dilating, and or constricting flow path and or lumen of tubes, ducts, vessels, urethras, ureters, and or any conduits etc. depending upon application and use, is carried out by using remotely, locally, and or automatically the said novel tubular implant device which may also be activated as a result of changes in values of specimens and or parameters where it is implanted and or driven by software program selection remotely or locally when meeting, exceeding, or lowering one or more specific condition(s) and or predicting specific analysis of current and historical measurements criteria and or even on demand.

It is yet related objective of the present invention as tubular implant device to provide an alternative and or substitute lumen path of tubes, ducts, vessels , urethras, ureters and or any conduits etc. for blocked, cut, injured, scarred, plaqued, enlarged and or narrowed tubes, ducts, vessels, urethras, ureters or any conduits etc. of male and or female for opening or grafting of various vessels, ducts, tubes, urethras, ureters and or any fluid circulation paths including controlling and regulating their flow paths based on various measuring parameters thereof.

It is related objective of the present invention to provide direct and or indirect treatments and or solutions for one or more problems which may include male and or female's contraception, sterilization, vasectomy, infertility, pregnancy, ectopic pregnancy, abortion, miscarriage,ovulation, pre and post ovulation hormonal prediction , fertilization monitoring and measurement problems etc. It is also the objective of the present invention to assist in reversing the situation where lumen path of mail and or female (such as tubes, ducts, vessels, urethras, ureters and or conduits and flowing paths etc.) is blocked, cut, injured, scarred, plaqued, enlarged, and or narrowed.

It is further related objective of the present invention to provide direct and or indirect treatments and or solutions for one or more problems and diseases in various conditions which may include erectile dysfunction (ED), urinary incontinence, benign prostatic hyperplasia (BPH) and or bladder outlet obstruction (BOO), etc.

It is also the objective of the present invention of the tubular implant to provide direct and or indirect treatments and or solutions for one or more problems and diseases in various conditions which are known in male and female as well as those conditions which may be known in future where the present invention can be utilized. SUMMARY OF THE INVENTION

The present invention consists of "Novel" tubular implant device and implant delivering apparatus (the implant device is placed in male and or female's tubes, ducts, vessels, urethras, ureters and or any conduits etc.) and methods which acts as an alternative to and or substitute for the lumen path for blocking, regulating, dilating, and or constricting partly, completely, or regulatory for continuous and or for a specific time or for repetitive cycles to control lumen paths of tubes, ducts, vessels, urethras, ureters and or any conduits etc. The control of such blocking, regulating, dilating, and or constricting fluid flow path and or lumen of male and or female's tubes, ducts, vessels, urethras, ureters and or any conduits etc. can be exercised by using remotely, locally, and or automatically the said Novel tubular implant device which may also be activated as a result of changes in values of specimens and or parameters where it is implanted and or driven by software program selection remotely or locally when meeting, exceeding, or lowering one or more specific conditions) and or predicting specific analysis of current and historical measurements criteria and or even on demand.

The Novel tubular implant device also provides an alternative and or substitute lumen path of tubes, ducts, vessels, urethras, ureters and or any conduits etc. for blocked, cut, injured, scarred, plaqued, enlarged and or narrowed tubes, ducts, vessels, urethras, ureters or any conduits etc. of male and or female for opening or grafting of various vessels, ducts, tubes, urethras, ureters and or any fluid circulation paths including controlling and regulating their flow paths based on various measuring parameters thereof. The present invention assists in treating and solving male and or female's contraception, sterilization, vasectomy, infertility, pregnancy, ectopic pregnancy, abortion, miscarriage, ovulation,pre and post ovulation hormonal prediction , measurement problems and fertilization monitoring. Similarly, in situations where lumen path of male and or female [such as tubes, ducts, vessels , urethras, ureters and or conduits and flowing paths etc.] is blocked, cut, injured, scarred, plaqued, enlarged and or narrowed, the present invention also assists in reversing these conditions.

The Novel tubular implant device may also be used directly or indirectly for treating, managing and controlling incontinence , benign prostatic hyperplasia (BPH), bladder outlet obstruction (BOO), erectile dysfunction (ED), vital systemic circulatory routes, fetal circulation, , vessels, etc. are just a few to mention.

The invention reveals following detailed description and drawings which illustrate the invention and the preferred embodiments of the invention in limited fashion and words and therefore not meant to limit the widest scope of the present invention.

DESCRIPTION OF THE DRAWINGS:

For a complete understanding and design detail of the present invention, and the advantages thereof, following drawings are taken in conjunction, where in:

FIG. 1 is a diagram which schematically illustrates an overview of the deployment of the tubular implant device in the fallopian tube and the operational application of the present invention as an application example.

FIG. 2 illustrates the operation and methods of the implant delivery apparatus for an exemplary tubular implant device deployment and removal.

FIG. 3 illustrates the operation and methods of the implant delivery apparatus in schematic of smooth bends in left, right, up and down or any X-Y 4-DOF direction of distal-end of delivery catheter.

FIG. 4 expresses the operation and methods of the implant delivery apparatus in schematic of screwing and unscrewing of the implant carrier tube for deployment and de-installation of the tubular implant device,

FIG. 5 illustrates multiple mechanisms for attachment and removal of the tubular implant device with the implant delivery tube. FIG. 6 is a diagram that illustrates steps in connecting the implant delivery catheter with implant delivery apparatus.

FIG. 7 expresses the internal lumen of the tubular implant device and electrodes configuration and external layers of the tubular Implant device with flexible soft edges.

FIG. 8 illustrates the internal structure, components and assembly of the tubular implant device.

FIG. 9 expresses the diagram of Remote-Controlled Implantable Un-Obstructed In-Line- With-Flowing-Path Tubular-Diagonal-Bendable-Knife-Gate intravascular tubular micro- actuator-valve.

FIG. 10 illustrates the internal structure and components of Implantable Un-Obstructed Ln- Line-With-Flowing-Path Tubular-Diagonal-Bendable-Knife-Gate micro-valve.

FIG. 11 illustrates additional examples of Implantable Un-Obstructed In-Line-With- Flowing-Path Tubular micro- valves.

FIG. 12 expresses tubular pressure, flow sensors and an XYZ accelerometer and motion sensors as additional embodiments of the Novel tubular implant device of the present invention.

FIG. 13 illustrates the multiple implanted locations of the fallopian tube and implanted view of the tubular Implant device. FIG. 14 illustrates example of alternating and or substitute of lumen for grafting of cut, scarred, blocked, narrowed, enlarged or defective fallopian tube.

FIG. 15 presents further central part and primary embodiment of the present invention to illustrate the prediction mechanism of menstrual cycle in contraception.

FIG. 16 illustrates the prediction mechanism plotted with tubular implant device electrodes and presented with flow-chart indicating how they interacts corresponding predictions in FIG. 15.

FIG. 17 illustrates the prediction mechanism of menstrual cycles in conception (pregnancy) and in continuation of the pregnancy.

FIG. 18 illustrates further the prediction mechanism of menstrual cycles in post conception and abnormalities of the pregnancy.

FIG. 19 illustrates the schematic of the preferred embodiment of the present invention to deploy the tubular implant in the fallopian tube with additional battery.

FIG. 20 illustrates the smart remote control device and alternative peripheral interface device.

FIG. 21 is a block diagram of electronic circuit blocks as part of the Novel smart remote- control device and alternative smart remote peripheral adapter. FIG. 22 is a block diagram of electronic circuit blocks as part of the Novel tubular implant device.

Fig. 23 illustrates another application usage example in which the Tubular Implant Device is implanted in Male to achieve Male Contraception.

FIG. 24 illustrates yet another application usage example in which the Tubular Implant Device is implanted in Male for the treatment, control and or managing Benign Prostatic Hyperplasia (BPH) and bladder outlet obstruction (BOO) conditions.

FIG. 25 illustrates demonstrate example of application usage in which the Tubular Implant Device is implanted in female for the treatment, control and or managing urinary incontinence.

FIG. 26-A and FIG.26-B illustrate the "Novel" application example of the Novel tubular implant device of the present invention to treat, and mange erectile dysfunction.

FIG 26-B illustrates the application example of novel tubular implant in treating and managing erectile dysfunction in relation to fig. 26-A.

FIG. 27 illustrates yet another application example of the tubular implant device of the present invention to provide "Novel" Implant- Assisted-Fertilization method and process.

The drawings illustrated above, are examples of preferred embodiments of the present invention and therefore not to be considered as a limiting factor of their widest scopes. DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention consists of "Novel" tubular implant device and implant delivering apparatus (the implant device is placed in male and or female's tubes, ducts, vessels, urethras, ureters and or any conduits etc.) and methods which acts as an alternative to and or substitute for the lumen path for blocking, regulating, dilating, and or constricting partly, completely, or regulatory for continuous and or for a specific time or for repetitive cycles to control lumen paths of tubes, ducts, vessels, urethras, ureters and or any conduits etc. The control of such blocking, regulating, dilating, and or constricting fluid flow path and or lumen of male and or female's tubes, ducts, vessels, urethras, ureters and or any conduits etc. can be exercised by using remotely, locally, and or automatically the said Novel tubular implant device which may also be activated as a result of changes in values of specimens and or parameters where it is implanted and or driven by software program selection remotely or locally when meeting, exceeding, or lowering one or more specific condition(s) and or predicting specific analysis of current and historical measurements criteria and or even on demand.

The Novel tubular implant device also provides an alternative and or substitute lumen path of tubes, ducts, vessels, urethras, ureters and or any conduits etc. for blocked, cut, injured, scarred, plaqued, enlarged and or narrowed tubes, ducts, vessels, urethras, ureters or any conduits etc. of male and or female for opening or grafting of various vessels, ducts, tubes, urethras, ureters and or any fluid circulation paths including controlling and regulating their flow paths based on various measuring parameters thereof.

The present invention assists in treating and solving male and or female's contraception, sterilization, vasectomy, infertility, pregnancy, ectopic pregnancy, abortion, miscarriage, ovulation, pre and post ovulation hormonal prediction, measurement problems and fertilization monitoring. Similarly, in situations where lumen path of male and or female [such as tubes, ducts, vessels , urethras, ureters and or conduits and flowing paths etc.] is blocked, cut, injured, scarred, plaqued, enlarged and or narrowed, the present invention also assists in reversing these conditions.

Referring now to the drawings, and initially to FIG. 1, it is to be noted that figures or drawings are not intended to be to scale as they actually exist in the assembled embodiments and are purely for the sake of greater clarity in the drawings of the present invention.

FIG. 1 is a diagram which schematically illustrates an overview of the deployment of the tubular implant device in the fallopian tube and the operational application of the present invention as an application example. Reference point 001 is a drawing of fallopian tube implant delivering device which works in conjunction with hystroscope device 005.

Hysteroscope is a standard medical apparatus used in Obstetrics and Gynaecology for examining uterus, fallopian tubes and so on. Hysteroscope is accompanied with standard display monitor 006. In order to provide source of light in the hystroscope, halogen light

007 is connected with it. A Multi-lumen fiber-optic probe is then passed in the implant delivery device 001 through implant delivery tube 041 which provides visual guidance to medical professional 008 throughout the procedure. Reference points 039 and 040 are the "U" shaped sockets providing physical support and placement of Hysteroscope 005 to be attached over implant delivery device 001. Both the devices inter se augment their best use and application . In some prior art procedures, hysteroscope is held with one hand and the invention device is held with the other hand thereby making it difficult and challenging to perform the procedure with accuracy and ease. In the present invention, it is combining them into one so that entire procedure can be performed with ease thereby significantly reducing or eliminating possible hand vibes and or jerks. In preferred embodiment, the present invention is also suitable and user friendly for both left-handed and right-handed professionals by adding similar controls and windows to both sides (left and right) of the implant delivery device as it is shown in one side of the view.

Implant delivery device consists of two pieces, the implant delivery device 001 and implant delivery catheter 026 which actually carries implant and deploys it in the fallopian tube. The implant delivery catheter 026 is joined and screwed at union 049 with implant delivery device 001. The purpose of making them in two pieces is that after the procedure the implant delivery catheter can be removed and proceeded for sterilization for re-use. And even after several procedures and re-uses of catheter, simply replacing the catheter with new one without replacing the implant delivery device, therefore adds several economical benefits along with other environment friendly practices. The implant delivery catheter 026 can be constructed with some modification in order to reach some other types of lumens for implantation where tubular implant device provides suitable application, however the implant delivery device 001 may still be able to provide sufficient novel mechanism to carry and implant (install) or remove the tubular implant device 002. The central piece of the present invention resides in the tubular implant device 002. The tubular implant device 002 in preferred embodiment is a self-contained tubular implant device which acts upon: (i) its saved program action automatically driven by cyclical hormonal changes of the female mammalian's menstrual-cycle determined by either directly or indirectly through various liquid (or fluid) ion-select electrolytes, proteins, enzymes, pH and or simply electrophysiology of cell membrane potential, current, capacitance and or conductivity along with temperature changes and or measuring flow of fluid passing inside the lumen of the tubular implant device 002, pressure and XYZ accelerometer position and acceleration of the tubular implant device; and (ii) also acts upon commands received from smart remote device wirelessly. The tubular implant device 002 has an internal "unobstructed" tubular lumen which starts from the first edge/entrance 042 of the tubular implant device to the second edge/entrance 045 of the tubular implant device. The tubular implant device 002 takes-over the entire internal lumen (intra-lumen) of fallopian tubes cylindrically within the length of the tubular implant device 002 thereby alternating to provide similar lumen path so that the tubular implant device 002 can control the lumen path by closing or regulating the actuating gate valve of the tubular implant device thereby making and acting it as a complete or partial closure of fallopian tubes to provide contraception by eliminating and isolating sperms and egg to meet if the tubular implant device 002 is set or programmed to do contraception. And if it is programmed or set to be good for pregnancy, the tubular implant device acts as an alternative clear unobstructed path for sperm and egg to meet for fertilization without the removal of the tubular implant device 002.

As stated, the tubular implant device 002 has implantable electrodes which measure continuously, periodically or pre-programmed set timing intervals, or on demand and or during specific pre-programmed event changes of pre-ovulation, ovulation, fertilization, post-ovulation and throughout during pregnancy right inside of the fallopian tubes where actual events of conception and contraception take place, and monitors entire course of pregnancy to avoid various life and health threatening risks. Electrode 052 is a common or reference electrode. The first set of implantable electrode group 050 consists of electrodes between 032 and 052 for determining and recording direct or indirect changes from fallopian tube fluid and its wall in at least one or more electrolytes' ions ( Na+, K+, Cl-, Ca2+, Mg2+ and or pH) using any kind or type of organic or inorganic, hybrid or monolithic, thin-film or non thin film (for example; liquid (or fluid) Ion-Select, ISFET type, CHEMFET, Organic or inorganic electrode or sensor, Plasma type, Hydrogel type, Electro- osmotic type, Polymeric type and or Solid State type Electrode/s or some other such types which may include chemomechanical, and or optical, and or electrochemical, and or chemical sensitive temperature type etc.) of single or multiple ion-select potentiometric, amperometric, conductometric and or capacitance electrodes and or simply electrophysiology potentials of cell membrane for conductive and or capacitive, and or voltage, and or current measuring electrodes to measure the value of specimen or specimens in the fallopian tube or vascular or other tubular flowing objects etc. For the construction of the implant it can choose any type of single or multiple electrodes from the group or from those available for the purpose specific to the single or multiple electrolytes. And similarly it can also be configured to have one or more bio-chemical sensors and or electrodes ( Na+, K+, Cl-, Ca2+, Mg2+ and or pH) and one or more of electrophysiology electrodes (voltage potential, and or impedance and or current, and or capacitance).

The second set of electrodes group 051 consists of electrodes between 046 and 047 for determining and recording direct or indirect changes from fallopian tube fluid and its wall in at least one or more electrolytes' ions ( Na+, K+, Cl-, Ca2+, Mg2+ and or pH) any kind or type of organic or inorganic, hybrid or monolithic, thin-film or non thin film (for example; liquid (or fluid) Ion-Select, ISFET type, CHEMFET, Organic or inorganic electrode or sensor, Plasma type, Hydrogel type, Electro-osmotic type, Polymeric type and or Solid State type Electrode/s or some other such types which may include chemomechanical, and or optical, and or electrochemical, and or chemical sensitive temperature type etc.) of single or multiple ion-select potentiometric, amperometric, conductometric, and or capacitance electrodes or simply electrophysiology potentials of cell membrane for conductive and or capacitive, and or voltage, and or current measuring electrodes to measure the value of specimen or specimens in the fallopian tube or vascular or other tubular flowing objects etc. For the construction of the implant it can choose any type of single or multiple electrodes from the group or from those available for the purpose specific to the single or multiple electrolytes. And similarly it can also be configured to have one or more bio-chemical sensors and or electrodes ( Na+, K+, Cl-, Ca2+, Mg2+ and or pH) and one or more of electrophysiology electrodes (voltage potential, and or impedance and or current, and or capacitance).

The values of group electrodes 050 and 051 are measured along with temperature value which is determined through electrode 048 which is in contact with fallopian tube wall on the outer side. The electrode 048 can be of any type which may include P-N junction silicone diode, thermistor, thermo-couple junction and or thermo-flux. As stated in the background of the present invention, Temperature is a very important parameter for conception, contraception and pregnancy and its changing values. And it has already been known that temperature in the fallopian tube is very important for fertilization and storage of sperms and it is clearly different from Basal Body Temperature (BBT) and it is difficult to rely on basal body temperature because temperature always differs in different internal organs and it continuously changes based on their autonomous activities in particular. However, outer body temperature is an external presentation to some extent of internal temperature changes and this change is always and most of times not immediate, instead could take a couple of days, hours or minutes before appearing to the external body. For this reason, any reliance on basal-body temperature is erroneous. Sperm uses heat sensors to find the egg in the fallopian tube much like guided missiles that sense the heat of a plane's engine similarly sperms are also guided to the fertilization site by temperature sensation which is usually in the ampulla region of the fallopian tube. Therefore, temperature is monitored right in the fallopian tube as in the preferred embodiment of the present invention.

Surface area 035 of the tubular implant device is an optional area where tissue bonding glue can be applied for the tubular implant device 002 to firmly join with fallopian tube wall for long-term implantation to avoid any leakage and dislocation of implant. The outer diameter of the tubular implant device 002 is bigger than the inner diameter of the fallopian tube lumen in order to firmly hold the implant and completely block sperms to pass from the outer layer of the tubular implant device 002, added for additional function and precaution. The tissue bio-adhesive glue can be applied by direct coating over the surface area 035 or through micro pours or holes of outer layer of the tubular implant device 002 or simply a tissue adhesive stripe or tape can be rolled around the implant at the surface area 035. The example of the tissue adhesive could be Cy anoacry late-based tissue glue or some other such type which can be removed easily. If the removal of tubular implant device is required, tissue bonding glue can be dissolved with its dissolvent solution. In preferred embodiment of the present invention, the surface area 035 can be larger and has expandable (or inflatable) outer diameter so as to firmly fix in the lumen path of tube, intravascular or other flowing path. Such expansion of middle outer diameter is stayed in low profile (meaning in smaller deflated) during installation or implantation of device 002 and or removal of the tubular implant device 002 and once it reaches its target location it is inflated to become thicker so that it could stay firmly in its position and does not get dislocated over time. Furthermore, such expansion or inflated outer diameter does not cause edema, inflammation or injury to the outer wall of the luminal path where the tubular implant device 002 is intended to be implanted. This is presented in FIG. 11 at 596 in 980 and 981.

The tubular implant device 002 also provides means of alternative to intra-luminal grafting for any types of blocked, scarred, injured, cut, plaqued and or narrowed tubes, vessels, artery, veins and or such tubular or vascular likes. For example, the tubular implant device 002 can also be used to reopen blocked fallopian tubes as described in FIG. 14 in more detail. In preferred embodiment of the present invention, the tubular implant device can be placed anywhere between uterus and ovary that is from intrauteral ostium to the infundibulum of the fallopian as described in Fig. 13 with more detail. Because lumen size is different at different length location of the fallopian tube, therefore, preferred embodiment of the tubular implant device 002's length, internal and outer diameter of the implant size can be varied according to its application and the specific size of the lumen where it will be implanted together with the consideration of the size of the individual person. Thus, it not only provides means of contraception and conception, but also helps to treat infertility and various other possible applications and treatments. The tubular implant device 002 with additional preferred embodiment assists Obstetrics and Gynecologist professionals, Pharmaceuticals and Researchers to enhance their work effectively and make precise and effective findings, tests and treatments for infertility and during IVF (In Vitro Fertilization) and related procedures in cases where tubular implant device 002 is implanted in the fallopian tube, and if it is installed in other locations of body, its relevant disease and complications can also have similar assistive role to the medical professionals, Pharmaceuticals and Researchers to enhance their work effectively and make precise and effective findings, tests and treatments in their respective area and field of applications.

The fallopian tubes are the channels between the uterus and the ovaries. Sometimes these tubes are found to be blocked or at least one is blocked or there is scaring or other types of damage to the tube. This damage can lead to infertility. Around 20 to 30% of infertility is caused due to these factors. Tubal infertility can be caused due to Pelvic Inflamatory Diseases (PED). As an infection begins, the body gets ready to attack. White blood cells and other fluids fill the tubes to fight the infection. If the body resistance is good it wins but in the bargain the fragile walls of the fallopian tubes get scarred. These circumstances can affect the functions of the ovaries and the blocked or scarred fallopian tubes that lead to infertility.

The incidence of ectopic pregnancy has significantly increased during the past two decades — more than four-fold from 4.8 to 20.9 per 1000 live births. Ectopic pregnancy remains the second leading cause of maternal mortality in the United States. Ectopic pregnancy results from a delay in the passage of the fertilized ovum through fallopian tube. This delay can result from anatomical abnormalities of tubes, such as constriction and false passage formation (e.g. diverticulum), or from tubal dysfunction as altered contractility or abnormal ciliary activity. Tubal anatomy and function can both be altered by either tubal surgery or prior PDD. These are often present together in the same individual. Approximately 95% of ectopic pregnancy occur in the tubes, in which most of them are located in its distal parts, particularly the ampulla. The other 5% of cases occur in the ovaries , rudimentary horn of bicornuate uterus, broad ligaments, peritoneum, and cervix

However, any discussion of ectopic pregnancy would be incomplete without mentioning of heterotopic pregnancy (coexistence of intrauterine and ectopic pregnancies). In Europe and the United States, this condition occurs in one of 2,600 pregnancies. With fertility treatments, the incidence of heterotopic pregnancy increases to as high as 3 percent. Heterotopic pregnancy is extremely difficult to diagnose, and 50 percent of cases are identified only after tubal rupture. If retention of the intrauterine gestation is desired, the ectopic pregnancy must be treated surgically. The surgical procedures predisposed to ectopic pregnancy include salpingolysis and ovariolysis, fimbrioplasty, neosalpingostomy, and tubal anastomosis. Although using micro-surgery technique (procedure) it can join and repair fallopian tube but the rate of success after surgery is less than 20%.

The preferred embodiment of the tubular implant device 002 in the present invention is used to treat infertility caused due to blocked, scarred or prior segmental resection of the fallopian tube due to ectopic pregnancy or tubal liagation or sterilization and other abnormalities. The tubular implant device 002 of the present invention, acts as a grafting path and device and allows broken or cut ends of fallopian tubes to re-join successfully along with other several added advantages of the present invention. This makes stitching or surgery area, or blocked or scarred area to be hidden longitudinally by the tubular implant device 002 where the tubular implant device is implanted in the affected fallopian tube as shown and presented in FIG. 14 in more detail. Re-joining of the tubal ends can be done using traditional and micro surgery or advanced procedure using tissue joining glue or laser stitching.

Pregnancy is generally divided into three trimesters. Each trimester consists of three menstrual cycles. It has been well established among obstetricians and gynaecologists that risk of pregnancy related complications and even death rate are greatest in the first trimester. If it passes perfectly and healthy, there are very high rate of successful delivery except in situational emergencies which are far less. According to WHO (World Health Organization), 15 to 20 percent of all pregnancies end in miscarriage which accounts for about 30 to 46 million. Most of them occur in the first 13 weeks, or first trimester. For women in their 20s and early 30s, the chance of miscarriage is about 15 percent. At 35 the chance of miscarrying rises to one in four, and at 40 the miscarriage rate is close to one in three.

Among other reasons of miscarriage, when body produces too much or too little of certain hormones, the risk of miscarriage may increase. Some researchers believe that low levels of the hormone progesterone, which is crucial to support in early pregnancy, cause between 25 and 40 percent of early miscarriages. If detected earlier and treated before it is too late, it can save human life and miscarriages can be avoided as well.

Furthermore, it was previously known that high bleeding rate during first trimester indicates that pregnancy will not survive. This has been proven wrong but only in developed countries where these women were given best advice for care and medical treatments. But in less developed countries, mortality rate is very high not only because easy access to medical treatment is not available or accessible but also more importantly because of lack of understanding and education to cope with the situation and therefore the patient falls victim of miscarriage or even dies due to post miscarriage complications. On the other hand, those women in developed countries who consume alcohol, drugs and smoking suffer serious complications during first trimester of the pregnancy. To prevent the pregnancy related complications, it is best to watch the pregnancy on a daily basis.

It is the preferred embodiment of the present invention not only to assist women (user) in contraception and conception but also to watch entire course of pregnancy 24-hour, daily or periodically. This is achieved in the present invention through its measuring electrodes and sensors sitting right inside the fallopian tubes and near the uterus and records (store or save) measured data in its (tubular implant device 002) memory and when smart remote device retrieves data it quickly computes data and examines for possible risk of early warning. This preferred embodiment allows girls/women in advance to avoid any unwanted life- threatening risks. For example, along with other pregnancy related predictions and detections, if embryo gets implanted and grows within the fallopian tube instead of uterus, it can detect in the present invention through its electrodes and sensors and it can give early warning before it could burst the fallopian tube permanently which may lead to death besides loosing fallopian tube permanently. This is described in detailed preferred embodiments of the present invention in FIG. 15, 16, 17 and 18 in more details.

Furthermore, changes recorded by the tubular implant device 002 and data computed by smart remote device 004 plus manually entered data of personal health signs, symptoms and conditions, as they appear from time to time, and when all this information is (both current and historical data from the tubular implant device 002 and data entered manually) computed using medical and statistical analytical algorithms and diagnostic software, it predicts the health of pregnancy in advance which can assist to avoid miscarriages, ectopic pregnancies and or other pregnancy related complications.

During the time of menstrual periods, fluid secretion from oviducts or fallopian tubes increases which ultimately passes through uterus and finally ejectes through vagina. This process performs self or natural cleaning of fallopian tubes especially after the death of an egg in the previous menstrual cycle. Therefore, any method that blocks fallopian tubes permanently is causing damage to the health of internal linings of fallopian tubes. In the preferred embodiment of the present invention, the tubular implant device 002 opens its lumen 100% and makes it obstruction-free once it is confirmed that ovulation cycle has passed and there is no chance of ovulation of an egg or at the end of menstrual cycle, it closes the lumen during pre-ovulation four to five days before the possible confirmed indication ovulation thereby eliminating the chance of fertilization and acts as a means of contraception either through its built-in battery power automatically (without any user effort or help) or through remote inductive power manually and continues its similar functions for the next cycles for many years during the life-cycle of the tubular implant device 002. This preferred embodiment of the present invention equips teen-aged girls who may not be in their good control of mind, especially those girls and women in less developed countries where women have no education or better conditions to manage and control their lives. This will help and ease millions of girls/women population around the world and also completely avoid death rows of more than million girls each year of the world who die during early age pregnancy and even after the birth their life becomes miserable for both mother and child. Another important gadget of the present invention is a smart remote device 004. Smart remote device 004 provides means of complete control and management of contraception and conception hence gives user power and independence without the need of professional help. A thick diameter inductive power antenna 027 delivers magnetic energy to tubular implant device whereas a smaller antenna 030 is a transceiver antenna for intercommunication between smart remote device and the tubular implant device 002. Reference point 028 is a visual text and graphics display giving full details of implant operation and contraception and conception management organizer(software). The text of display can be produced in several different languages as required by specific country, for example English, French, Spanish, German, Chinese, Japanese, Arabic, Urdu, Hindi, Malaysian, African, Thai, and Vietnamese etc.

Implant delivery catheter 026 has several parts which will be discussed later in greater detail. However, it is mentioned here briefly to some extent as a means of introduction. The catheter has four radio-opaque and ultrasonic markers 022, 023, 024 and 025 respectively to watch it over x-ray and or ultrasonic scanner while it is inserted in the reproductive organs. At the far distal end, 021 is an illumination representing halogen light coming out from the tubular implant device lumen through multi-lumen fiber-optic catheter from hysteroscope 005. The tubular implant device 018 is screwed inside of implant delivery catheter 026 by implant delivery tube. Implant delivery catheter 026 has two other very important components which include angular direction manoeuvring or bent spring 020 and additional battery carrier belly 019.

The implant delivering device 001 carrying the tubular implant device 018 at the implant delivery catheter is inserted in the vagina 009 all the way up to the uterus 010 where it is bent angularly towards fallopian tube Oi l. The diagram shows pre-installed implant 016 at the right fallopian tube 015. The tubular implant device 002 can be placed anywhere in the fallopian tube, as shown and present in FIG. 13 in detail. At the distal end of fallopian tubes are Ampulla 013 and 031 which holds egg for fertilization from either one of ovary from 012 or 014. Smart remote device 004 energy generator antenna 027 causing magnetic field 029 inhibiting magnetic current flow in the installed tubular implant device 016 of 017 for additional power.

FIG. 2 illustrates the operation and methods of the implant delivery apparatus for an exemplary tubular implant device deployment and removal. The implant delivery device 082 is used in combination of hystroscope 081. Multi-lumen fiber-optic cable 091 passes inside of implant delivery tube 090 at 151 and it is shown in bigger view at 154 for clarity. Two glass windows 089 and 088 are shown in implant delivery device 082 for visual forward and reverse movements of implant delivery tube 090 along with rotating gears which will be discussed in more details. Between two windows, a forward and reverse gear selection knob 087 causes shift in gear selection. And below gear shifting knob 087 is a main implant carrier knob 085 which operates in both forward and reverse directions exerting force to the gears which causes implant delivery tube to move forward or reverse. At the back-lips of implant delivery device 082 is a partial rotating knob 084 with angular scale in positive and minus angle ranges causing the distal edge of implant delivery catheter to bend in left or right directions. At the bottom of implant delivery device 082 is a flexible handle 083 which can be rotated or shifted up or down wards with geared steps to comfort the holding of entire device during procedure. At the proximal end of pipe of the implant delivery device 082 is a Castle- Arch 092 which has two nuts to cause implant delivery tube 090 to constrict thereby to rotate implant delivery tube 090 along with nuts clock-wise or anti-clockwise for screwing or unscrewing of the tubular implant device. 093 is a union which joins implant delivery catheter 152 with implant delivery device.

Implant delivery catheter 152 is hi conical shape towards distal end, where it holds the tubular implant device at 095. The distal end of the catheter has radio-opaque and ultrasound coating bands to be detected during procedure to assist professional not only to guide but also to give overall view of the entire insertion of the implant delivery catheter. The second such mark 100 (with two bands or stripes) is placed at the beginning of tactile spring 098 and third mark 101 (with three bands or stripes) is placed at the beginning of battery carrier belly 096. The fourth such mark 102 (with four bands or stripes) is placed a few centimeters away, which is approximately near the internal lumen of the cervix.

An enlarged view of distal end of implant delivery catheter 108 is redrawn for clarity. The delivery catheter consists of five stages in which first stage marked at 103 shows lumen of the catheter which is further elaborated in 112 and 113. The 103 end is not fully open instead, it is rounded down to reduce the sharpness of the edges to avoid any injury and to provide soft and easy contact with organ walls. This will decrease the lumen size on the outer edge. However, when the tubular implant device comes out from the edge its flexible area of 105 expands outwards to increase internal lumen. The second stage is an implant housing 105 of catheter where the tubular implant device is rested and delivered out through opening of 103. Therefore material of first and second stages is soft, flexible and stretchable. Second stage 105 is not fully tubal or pipe shape. It is sliced longitudinally as shown in 104 in the center to provide dual functions. One is to allow easy stretch out and second is to allow cables of additional battery of the tubular implant device to pass through for implant delivery which is shown in more detail at FIG. 19. It is further enhanced in 112 and 113 where sliced area 111 and 114 is stretched out thereby increasing lumen size thus allowing easy exit and entrance of the tubular implant device. The third stage is an angular bent spring 106 which is controlled by knob 084. It is described in more detail in Fig. 3. The fourth stage carries stretchable belly 107 to carry additional battery. Finally, the fifth stage or remaining part of delivery catheter is in a conical shape, which joins with delivery device at union 093. It is described in more detail at Fig. 6.

Knob 133 shows enlarged side view of 085 whereas 134 is a scale representing the distance measurement with knob 133 or 085. The scale shows in millimeters and centimeters to precisely measure the location of tubular implant device in the fallopian tube where it will likely be installed or implanted. Forward and reverse delivery of implant is achieved through knob 133 or 085. Gear shift knob 087 controls the gear directions. When it is set at directionl21, the gears 130 and 132 are forced and constrict with implant delivery tube 131 in such a way that when knob 133 rotates in forward direction, it exerts force over gears 130 and 132 to rotate and push tube 131 in forward direction. And gears 126 and 128 are released and set away from tube 127. The gears are further shown in bigger view at 115 and 117. In forward direction, gear 115 rotates anti-clockwise whereas gear 117 clockwise and pushes tube 116 forward (from left to right). When gear shift knob 129 is shifted downwards or in reverse direction, it causes gears 118 and 120 to get released from tube 119 and set away from tube, whereas gears 122 and 125 are constricted with tube 124 to exert pressure in such a way that when knob 133 rotates in reverse direction it pulls tube 124 from right to the left. This is shown in bigger view at gears 115 and 117, where 115 rotate in clockwise and 1 17 in anticlockwise to pull back tube 116.

Above description is shown diagrammatically from implant delivery catheter A, B, C and D at the bottom of Fig. 2. During A position, the distal opening of catheter 135 is in resting or least lumen size. As it approaches B position, the distal opening of catheter 139 is expanded or stretched out to let the tubular implant device come out. This difference has been explained in 111 and 114, it is however further elaborated here by two differential circles to be noted at 136 and 141. Delivery catheter at position C shows complete exit of the tubular implant device 146 when it reaches 148, the delivery tube 147 causes the tubular implant device 148 unscrewed and get released as shown in position D. At this point, delivery tube 150 along with fiber-optic cable 149 is withdrawn and returned back into the delivery catheter as shown in position D. The de-installation or removal of the tubular implant device can also be performed by taking position and methods in reverse order from position D to C, B and all the way up to position A, except that delivery tube 148, when it reaches the tubular implant device, it screws the implant so as to hold implant firmly to pull back from the fallopian tube. Before proceeding for removing of implant, dilator solution is to be applied to soften and enlarge the easy opening of reproductive organs which include vagina, cervix, uterus and fallopian tubes. It is further noted that, if adhesive glue was applied during implanting of the device, a glue dissolvent is to be applied prior to the procedure for easy and smooth removal of the tubular implant device. As described in FIG. 11 at 596 in 980 and 981, in order to implant or fix the implant, the outer diameter of the tubular implant device is inflated as shown in FIG. 11 in 981 at 988 to increase thicker diameter so as that the tubular implant device gets fixed and tightened in the luminal wall through local or remote control command. And when it is required to remove the implant, screw the tubular implant device first and then deflate the outer diameter of the tubular implant device as shown in FIG. 11 in 980 at 985, and then proceed from "C" to "A" backward as shown in FIG. 2.

FIG. 3 illustrates the operation and methods of the implant delivery apparatus in schematic of smooth bends in left, right, up and down or any X-Y 4-DOF direction of distal-end of delivery catheter. Fig. 3 shows how the implant delivery device 182 is used in conjunction with hystroscope 181, for visual guidance. 185 is the handle of the implant delivery device 182, which can be moved upwards as shown in 186 in smaller tethers-gear steps. At the back lips of the implant delivery device is a catheter bent knob 184 along with angular scale 183 in positive and negative angles. The functions and operations are drawn diagrammatically for clarity of the present invention. 211 and 212 are the larger views of the angular bent knob and the scale. These views show the direct impact on the distal end of delivery catheter 208 to show degree of left and right bend as shown in 209 and 207 respectively, while the tubular implant device 206 and 210, position of the implant and implant housing stays steady and unchanged but continues to bend along with spring 209 and 207 thereby controlled with the angular direction knob 211. Spring 190 at catheter 187 is shown below in greater detail.

The spring 193 is connected with plates 192 and 197 at both ends while keeping maximum internal lumen for implant delivery tube to pass through. 192, 193 and 197 are covered with a flexible and stretchable shield 194, which is directly joined with the delivery catheter. Top spring holding plate 192 is connected with two hard wires ,first 195 and second 196, from outside of the spring 193. The right angular bend of the catheter is achieved by rolling first hard wire 195 while unrolling second hard wire 196 at the same time. The left angular bend of the catheter is achieved by rolling second hard wire 196 while unrolling first hard wire 195 at the same time. This is achieved through two pulleys 200 and 202 respectively which are joined with axle 203 as shown in block 214. Axle 203 is ended and connected with two bushes 199 and 204. At the center of axle is an angular bend knob 201. In preferred embodiment, at least one of the hard wire is rolled in a forward or clockwise direction over pulley 202 as indicated in 205, whereas the second hard wire is rolled in a reverse or anticlockwise direction over pulley 200 as indicated in 198. In this scheme, when knob 201 rotates upward, it rotates the axle 203 in a clockwise direction which causes pulley 202 to roll the hard wire 196 while simultaneously the axle 203 causes pulley in clockwise but hard wire is placed in the opposite direction which will cause hard wire 195 to unroll, thus, bending the spring assembly to the left. Similarly, when knob 201 rotates downwards, it rotates axle 203 in anti-clockwise direction which causes pulley 200 to roll hard wire 195 and at the same time the axle 203 causes pulley 202 in anti-clockwise but hardwire 196 is placed in the opposite direction from 195 which will cause hard wire 196 to unroll, thus, bending the spring assembly to the right. This makes the implant delivery catheter to bend in two directions. However, another preferred embodiment of the present invention is that the delivery catheter can also bend in up and down directions when implemented with four hard wires. This is shown in 218 where block 216 and 215 function similarly as it is shown and described in 214. Knob 183 drives 215 for left and right bend directions whereas knob 217 drives 216 for up and down directions.

FIG. 4 expresses the operation and methods of the implant delivery apparatus in schematic of screwing and unscrewing of the implant carrier tube for deployment and de-installation of the tubular implant device. Fig. 4 shows the implant delivering device 242 in implant delivering or implant removing where its catheter reaches the location inside fallopian tube 248. The mechanism to deliver (leave) or remove the tubular implant device in the present invention resides in two major components: (i) The Castle Arch 243 and two nuts 241 and 244;& (ii) Specific type and construction of implant delivery tube 276 and inner threads 253 at the distal end of the delivery tube 254.

The Castle Arch 243 is further elaborated below in a detailed description. Hollow castle nut 244 is drawn in more clarity at 266 and 263. Top view of hollow castle nut is shown at 266. It is hex shaped from the outside but conical tapered castle at the inside as shown in the lumen 265. The hollow castle is further presented at 263 with side view where 264 is the hollow tapered castle with threads. The second nut 241 is a hollow castle nut with threads on the outer skirt as shown in 261 of 259. Castle nut 259 is a hex shaped at the outer side. The preferred embodiment of the present invention is that tapered castle nut 259 of 261 threads is screwed inside of a hollow castle nut at 264 of 263. As the two nuts threads in each other, tapered castle portion 261 constricts the implant delivery tube 262 so tightly as shown in 258 that when combined nut 258 rotates together it actually rotates the implant delivery tube 257 in clockwise and anti-clockwise directions, in such a way that the tube 254(shown at the top) if rotated in a clockwise direction it screwed the implant 251 as shown in 250 and 249. And if it rotated in anti-clockwise direction, it unscrewed the implant 251 as shown in 254.

The second embodiment resides in the implant delivery tube 268. The said tube consists of four parts which include area 271, 272, 273 and 274 respectively. The entire tube from the inside is round in shape and lumen, shown at 269 and 278 at the both ends of the tube. Area 271 has threads 270 at the inside of the tube lumen towards the distal edge of the said tube (the implant delivery tube) which actually screws the tubular implant device at 270. The second part is area 272, a simple tube; round, very smooth, soft and flexible at the inside and out side. This is the area which actually comes out from the catheter as shown in Fig. 2, so that it does not cause any injury or friction to the fallopian tube wall.

The third embodiment of the implant delivery tube is area 273 which is relatively more complex. The inner lumen is smooth and round-shaped but the outer surface has gear-type teeth 275 which is actually driven by gears as shown in Fig. 2. Another embodiment of the said part is that, it is not completely in round shape from the out-side, instead both left and right edges are trimmed to be flat in such a way that castle nuts 258 constrict the tube with the least possible friction thereby rotating it clockwise or anticlockwise as the nut 258 rotates without friction. The fourth part of the said tube is again flat and simple and round from both inside and outside as shown in 277. At this end fiber-optic cable 279 enters the tube (it is also shown in Fig. 2 at 154) all the way and reaches the area 271 and even goes inside the lumen of the tubular implant device as shown in Fig. 2 of A through C. A cross- section of the fiber-optic cable 267 is coming from earlier described hystroscope in Fig.l, of which 263 is a camera lens that takes the visual picture of the inside of the uterus or fallopian tube etc. whereas 237 and 239 are two lumens which actually send additional lights for the camera lens 263 for better visual capture.

FIG. 5 illustrates multiple mechanisms for attachment and removal of the tubular implant device with the implant delivery tube. As shown and described in FIG. 4, distal end of implant delivery tube 254 has threads in the internal lumen as shown in 253, whereas partial and enlarged view of the tubular implant device 251 has similar threads at the outer edges of both sides. This makes the tubular implant device 249 to be screwed with implant delivery tube firmly until it is to be unscrewed after implanting the device as shown and explained in FIG. 4. The tubular implant device 311 also has 2 or more semi "U" shaped holes at both edges as shown in 312 which have through-holes bend in the lumen 313. In addition to threads at distal end of the tubular implant device and implant delivery tube, an umbrella cap is designed to be attached and screwed with implant delivery tube as shown in 323 where it is screwed with 321 at 322 which can grasp the tubular implant device 320 as shown in 328. Hard spring bend 315 or 327 are inserted in the 326 of "U" shape holes of the tubular implant device from all such holes thereby grasping implant firmly where it can be pushed forward and pulled back.

FIG. 6 is a diagram that illustrates steps in connecting the implant delivery catheter with implant delivery apparatus. 304 is the Castle- Arch and at the distal end is a union 303 which has a union hex nut 302 and nut threads 301. Burndy cable splicers 299 and 300 interconnect hard wires 296 and 297 respectively. Hard wire 296 and 297 ends are welded with round ball 298. Burndy cable splicer is shown in bigger scale at 291, where two cables

290 and 293 whose balls ends are placed under the screw of Burndy cable splicer left and right respectively as shown in 293. Once both wires are connected as shown in 282, the hex nut 302 is screwed to both ends of union 303 and catheter 294 over 302 and 295 threads as shown in 281.

FIG. 7 expresses the internal lumen of the tubular implant device, electrodes and their configurations, and external layers of the tubular implant device with flexible soft edges depending on the type of material used in construction (as it is listed out later within this paragraph). Internal lumen pipe 365, in preferred embodiment of the present invention consists of three segments. First, distal segment 368 is extra smooth tapered and conical shape inwards to the middle of lumen pipe 365, thereby giving larger cylindrical opening space and second segment 369 is a flexible lumen segment of the pipe 365. The middle lumen diameter 365 is dependent on the diameter of lumen of fallopian tube or vessels or artery/vein for which it will replace to alternate the lumen path which can be in any shape either straight, curved, conical or i.e. any geometrical (like round, oval, octal, hex, square, rectangular, triangular etc.) or non geometrical shape to mimic the replacement of the object shape. The third segment 370 is a reverse conical segment which is bigger in proximal end but smaller at the middle or second segment to provide smooth flow path exit. Both ends of lumen pipe 365 are open (clear) and hollow as shown in 366 and 367. The internal lumen pipe can be made with any implantable material from one or combinations of one or more materials, with or without making an alloy, which include Elgiloy, Phynox, MP35N, Titanium, Titanium Alloy, Nitinol, Tantalum, Silver, and or Gold etc., and or one or more combination of materials such as Silicon, Ceramics, Polyurethane, combinations of silicone with polyurethane, Elast-Eon, AV Fistula, Dacron, ePTFE, and or Procol etc. with or without tissue-engineering and are coated with bio-compatible materials and may also be coated with drug eluting if required. The type of drug eluting material can be selected based on its specific application, location and environment.

The tubular Implant device 341 presents another preferred embodiment in which the outer shape of the tubular implant device is very specific and divided in three segments. At the distal segment 356 the implant is tapered downwards conically and it can be made in any shape either straight, curved, conical or any geometrical (like round, oval, square, octal, hex, rectangular, triangular etc.) or non geometrical shape to mimic the replacement of the object shape where it will be implanted. At the proximal edge of segment 356 are threads 348 and lumen 346 which replaces or alternates the lumen of fallopian tube or vascular etc. "U" shaped through-holes hooks 350 with bends are placed and have one or more electrodes 351 which can be placed anywhere in the first or second segment. The second segment 357 in preferred embodiment is bigger and thicker in outer diameter to fix firmly within the replacing lumen. Similarly, it can also be in any shape either straight, curved, conical or any geometrical (like round, oval, square, octal, hex, rectangular, triangular etc.) or non geometrical shape to mimic the replacement of the object shape where it will be implanted. This is the center area where most of internal components of the tubular implant device are assembled. Tissue adhesive glue, coating or tape 342 is placed at 355. In this segment most of electrodes and or sensors can be placed. Electrodes 352 and 351 as shown will be illustrated in detail shortly. Third outer segment 358 is reversely tapered and conical towards the proximal end. It can be in any shape either straight, curved, conical or any geometrical (like round, oval, square, octal, hex, rectangular, triangular etc.) or non geometrical shape to mimic the replacement of the object shape where it will be implanted. At the proximal end it has threads 349 to be used by implant delivery device, whereas 347 is an open lumen for entry and or exit lumen. The electrode 354 can also be placed either in the third segment or in the second segment depending on the application and requirements.

All electrodes 361, 372, 362, 363, and 364 are open from the internal lumen as shown in 360 thereby giving maximal space for other internal components assembly to be installed and electrical connections from or towards the electrodes and their control circuit assembly. In preferred embodiment, these electrodes can also be placed in the internal lumen of the internal lumen tube as shown in 375. Furthermore, in another preferred embodiment, these electrodes can also be installed; some in the internal lumen tube and some in the outer diameter or some internally and externally interconnected for both internal and external measurement readings. In still further embodiment of the present invention, the electrodes and or sensors can be constructed in any geometrical and or non geometrical shape, size, diameter and thickness and it may also be in thin-film layer as hard, soft and or flexible form and or coated material and or otherwise in any hard or soft form (two examples are shown for reference: one is in ring shape as 361, 372, 362, 363, and 364 wherein each ring shape can have one electrode or sensor for one specimen select or one ring can have multiple electrodes and or sensors for multiple specimens selects; and the second is in vertical bars as shown in 376 and 377 wherein each vertical bar can be a single measuring electrode or sensor hence making a group of multiple electrodes and sensors for multiple specimen selects or all vertical bars together representing one measuring electrode and sensor for one specimen select). The first group of electrodes or sensors consists of 361 and 372 which determine the direct or indirect changes in fallopian tube or vascular fluid and its wall in at least one or more electrolytes' ions ( Na+, K+, Cl-, Ca2+, Mg2+ and or pH) any kind or type of organic or inorganic, hybrid or monolithic, thin-film or non thin film (for example; liquid (or fluid) Ion-Select, ISFET type, CHEMFET, Organic or inorganic electrode or sensor, Plasma type, Hydrogel type, Electro-osmotic type, Polymeric type and or Solid State type Electrode/s or some other such types which may include chemomechanical, and or optical, and or electrochemical, and or chemical sensitive temperature type etc.) of single or multiple ion-select in potentiometric, amperometric or conductometric electrodes or sensors to measure the value of specimen or specimens in the fallopian tube or vascular or intravascular fluids and or simply electrophysiology electrodes to measure the value change in cell membrane wall of fallopian tube or vascular or intravascular for conductance, voltage potential and or capacitance. For the construction of the implant it can choose any type of single or multiple electrodes and or sensors from the group or from those available for the purpose specific to the single or multiple electrolytes and or conductivity and or voltage potential and or capacitance. The electrode 372 is a reference electrode and augments the first electrode 361. The type and material of electrode 372 is directly dependent on the electrode 361 combination. Electrode 362 is a temperature sensing electrode at the outer layer. The second group of electrodes consists of 363 and 364 which determine the direct or indirect changes from fallopian tube or vascular or intravascular fluid and its wall in at least one or more electrolytes' ions ( Na+, K+, Cl-, Ca2+, Mg2+ and or pH) any kind or type of organic or inorganic, hybrid or monolithic, thin-film or non thin film (for example; liquid (or fluid) Ion-Select, ISFET type, CHEMFET, Organic or inorganic electrode or sensor, Plasma type, Hydrogel type, Electro- osmotic type, Polymeric type and or Solid State type Electrode/s or some other such types which may include chemomechanical, and or optical, and or electrochemical, and or chemical sensitive temperature type etc.) of single or multiple ion-select potentiometric, amperometric or conductometric electrodes or simply electrophysiology electrodes to measure the value change in cell membrane wall of fallopian tube or intravascular for conductance, voltage potential and or capacitance, electrophysiology a conductive and or capacitive electrode to measure the value of specimen or specimens in the fallopian tube. For the construction of the implant it can choose any type of single or multiple electrodes and or sensors from the group or from those available for the purpose specific to the single or multiple electrolytes and or conductivity, potential and or capacitance. In preferred embodiment of the present invention, type of fourth electrode and or sensor in terms of ion selection and either conductivity, voltage potential and or capacitance measurement is different from the first electrode type and type of ion selection thereby having more in quantity of each individual specimen.

The outer layer or encapsulation 359 of the tubular implant device 341 can be made with any implantable material from one alone or combination of materials, with or without making an alloy, which include Elgiloy, Phynox, MP35N, Titanium, Titanium Alloy, Nitinol, Tantalum, Silver, and or Gold, and or Silicon, (where electrical conductive material is used for outer encapsulation, it will add insulation surroundings for electrodes placement in such a way as to leave outer surface of electrodes to be in contact with tissues and fluids) Ceramics, Polyurethane, combinations of silicone with polyurethane, Elast-Eon, AV Fistula, Dacron, ePTFE, and or Procol etc. with or without tissue-engineering and are coated with bio-compatible materials and may also be coated with drug eluting if required. The type of drug eluting material can be selected based on its specific application, location and environment. The outer layer 359 can also have two encapsulations, in which first inner layer is encapsulated with hard material whereas second layer can be softer layer so as to be soft and gentle with implant and tissue contact.

Another preferred embodiment of the present invention is the tubular implant device which can have additional flexible and to some degree stretchable first and third internal and outer segments to best suit the ever moving vessel, lumen or body movements and bends in any direction as it bend itself. This is shown in 374. The tubular implant device is relatively longer in size and carries all internal components assembled within the second segment 383 and leaving both first and third segments 381 and 383 respectively to extra soft, flexible, bendable and to some degree stretchable. This is shown figuratively in 386 and 400 where 385 and 389 are the second or central segments. First and third segments 384, 387 and 388, 399 respectively demonstrate bend on left and right directions in any 360-degree. However, it can also be bent in the opposite direction for example first in the left and the third in the right direction or vice versa in any 360-degree.

FIG. 8 illustrates the internal structure, components and assembly of the tubular implant device 421. The tubular implant device 422 shows major components. Inductive coupling coil 423 is wound around the implant 424 (which can be wound with wire and or coil is made using flexible polyimide circuit with printed layers in coil form) which transfers electromagnetic energy to control circuit 425 which converts electromagnetic energy in regulated DC voltage to initialize and charge internal battery and perform various intended functions and operations of the tubular implant device. The tubular implant device 421, when assembled with nano bio-thermal battery (a battery which converts body heat into electrical potential), the inductive coupling coil is removed. All semiconductor components are surface mounted over multi-layer polyimide circuit 426 which can be rolled, bent, flattened or in any form best suited to the internal available space. All micro and nano scale semiconductor wafers and components are placed over flexible polyimide circuit 426. However, detailed description of the circuit 426 is described in FIG. 22 along with FIG. 21. The tubular implant device 427 further illustrates the internal components assembly. The tubular implant device 427 can be installed with one or more types of nano batteries. The first nano battery could be from any implantable battery or from Bion, mPhase or other such type, and second type of battery is a nano Thermal Battery which converts internal body heat into the electrical energy and continues to work for several years without replacing it as it continues to charge with body heat. Micro actuator 428 and gate valve 430 hold the preferred embodiments of the present invention. A "Remote-Control Un-Obstructed In- Line-With-Flowing-Path Tubular-Diagonal-Knife-Gate Intravascular (or free-flow dual- Pinch Symmetrical Tubular Valve, Tubular Cone Valve, Tubular Knife-gate Valve or Diagonal-angular Knife-Gate Valve, or Micro-Balloon Valve type etc.) tubular actuator valve" triggered or initiated or regulated through pre-programmed and or initiated or regulated based on internal physiological changes either direct or remote controlled action can be made from any multilayer Piezo material or X-Actuator type (which is made from new magnetic material Ni2MnGa) or any type from other micro or micro-miniature actuator type which include electrostatic, electromagnetic, thermomechanical, phase-change, piezoelectric, shape-memory, electroheologicical, electrohydrodynamic, magnetostrictive and or diamagnetism or any other micro-miniature or MEMS based micro-miniature actuator thereby alternating and controlling vascular and or intravascular lumen, artery, vein, vessel and or fallopian tubes in particular for contraception, conception and pregnancy and various other applications. The tubular implant device 431 is further disassembled to show internal lumen tube 432 where it is dismantled from the body as shown in 433, & wherein 431 is an outer encapsulation layer, 432 is an internal lumen tube in such a way to create housing space for implant's components as shown in 436. In preferred embodiment of the present invention, an example of cross-section layers is shown at 434 for reference and understanding, however, the implant assembly can be constructed in various ways as long as all basic components can be placed according to the space of application and its specific environment. All layers are self-explanatory from their name references. 1100 shows electrodes/sensors at the internal lumen, 1101 is internal lumen of the tube with bio- compatible coating and or drug-eluting layer. 1102 shows actuator/motor and valve, 1111 is electronic circuit and battery assembly, 1103 is an outer surface shell and concealment with bio-compatible and or drug-eluting layer. 1104 shows electrodes/sensors at the outer layer, bonding glue strip 1105 is an optional choice, 1106 is an outer inflateable balloon layer, 1107 is a second heat insulation, 1108 is an inductive coupling coil, 1109 is first heat insulation, and 1110 is a gate valve.

FIG. 9 expresses the diagram of Remote-Controlled Implantable Un-Obstructed In-Line- With-Flowing-Path Tubular-Diagonal-Bendable-Knife-Gate intravascular tubular micro- actuator-valve. The tubular implant device 434 shows tubular micro-actuator and its gated valve assembly using Piezo material for example to describe invention, however, as described in earlier paragraph of FIG. 8, it can be constructed differently as stated according to the type of material and its operational principle. Tn preferred embodiment of the present invention 437 is a tubular inner stator electrode of Piezo actuator placed over internal luminal tube 435. Outer tubular actuating electrode 436 is placed over inner electrode 437. When Piezo electrodes are energized in one direction, it actuates from left to right (meaning from one position to the other) as shown in 436 and 437 and when energized in opposite charge, it actuates from right to left as shown in 453 and 452. Both inner and outer tubular Piezo electrodes have contact switches at their edges from 438, 439, 440 and 441 and 450, 451, 455 and 454 respectively indicating control circuit to its maximum physical actuation limits, where contact switch 438 makes electrical connection with 439 while contact switch 440 is separated from its maximum actuating distance from switch 441. In preferred embodiment, internal luminal tube 435 is cut at 442 in diagonal at the distal half of 445 making it in two pieces where 443 and 444 are internal lumen of cut tubes 445 and 435 respectively. Contact switch can be built in several ways. Two examples are shown for clarity in which 448 is a micro-miniature spring contact switch whereas 556 is a microminiature tensile L-shape lever switch using micro-machined tooling. Contact pad 446 is attached at the first end of spring 447 and second end of the spring is attached with contact leg 448. In other example, contact pad 557 and 558 are attached at the first end of L-shape lever 556 and 559 respectively and second ends of the L-shape tensile levers are connected in the shell of tubular Piezo electrodes. In addition to micro-miniature switches, tubular micro-actuator is coupled with variable potentiometer (Resister) 561 between stator and actuator electrode shell as shown in 564 and 565. As 563 moves along with actuator towards 562 it causes change in resistor which directly reflects the percentage of actuator movements as well as percentage of the gate valve open or close. FIG. 10 illustrates internal structure and components of Implantable Un-Obstructed In-Line- With-Flowing-Path Tubular-Diagonal-Bendable-Knife-Gate micro-valve. Internal luminal tube 615 is being shown as enlarged view for clarity in which diagonal luminal tube cut 614 is further shown valve assembly at 583 and 584 respectively. Two half pieces diagonal tubular channel sockets 582 and 585 are placed at internal luminal tube 581 and 586 to secure and air-tight luminal tube edges 583 and 584 each respectively. Diagonal tubular channel sockets 582 and 585 are made using micro-machined molding and or tooling with one or more single or mixing of materials which may include PET, Nylons, PE (polyolefins), Polyurethanes, PVC (flexible or non flexible), Silicon, Ceramics, Polyurethane, combinations of silicone with polyurethane, Elast-Eon, AV Fistula, Dacron, ePTFE, and or Procol and from metals it may include Elgiloy, Phynox, MP35N, Titanium, Titanium Alloy, Nitinol, Tantalum, Silver, and or Gold. Diagonal tubular channel socket provides insulated and concealed channel for diagonal bendable knife gate slider as shown in 589 and onwards in FIG. 10 where it moves freely and when it is in open valve position, the said channel socket does not obstruct the flowing path not even inner surface or luminal wall of internal luminal tube. Diagonal bendable knife gate slider 589 shows the central circle boundary 590, where 588 and 591 tube edges of 587 and 592 respectively are met on both sides each respectively during close valve position thereby making closure while creating air-tight vacuum-like isolation not to allow any smallest and thinnest sperm to cross the gate through outer wall. Both socket and gate-knife are coated with bio-compatible materials and may also be coated with drug eluting if required. The type of drug eluting material can be selected based on its specific application, location and environment. Knife gate has lever 380 which is extended out to be connected with actuating shell of the actuator as shown in 606 and 612 respectively. The bend of knife gate is elaborated in reference point 599. Lever 618 has connecting hole 597 which interconnects with actuator. Lever 618 is encapsulated with flexible and stretchable jacket 598 to air-tight and conceal knife gate between channel socket and internal luminal tube 587 and 592. Flexible and stretchable jacket 598 can be made of any material which may include PET, Nylons, PE (polyolefins), Polyurethanes, PVC (flexible) etc. and coated with bio-compatible materials and may also be coated with drug eluting if required. The type of drug eluting material can be selected based on its specific application, location and environment. Each piece of channel socket 582 and 585 is bonded with either or both bonding glue and laser welding with internal luminal tube 581 and 586 at their edges 583 and 584 respectively. Once knife gate assembly 599 is placed inside the channel socket, both ends of channel socket are bonded permanently with bonding glue, heat and or laser and finally become one piece as shown in 603 and 610. Reference point 603 is illustrating valve closure whereas 610 is illustrating valve opening. Channel sockets 605 and 608 housing diagonal bendable knife gate levers 608 and 612 respectively are connected with tubular actuators 602 and 607. When valve is closed, all types of fluids, air, gas, material or objects, hot or cold (depending on the type of material used in construction of valve, tube and actuator as stated above) are stopped as shown in 604 and when valve is open, it allows any type of fluid, air, gas, material or object, hot or cold {depending on the type of material used in construction of valve, tube and actuator as stated above) to pass or flow freely (un-obstructed) at 609.

FIG. 11 illustrates additional examples of Implantable Un-Obstructed In-Line-With- Flowing-Path Tubular micro-valves. The first additional example of Implantable Unobstructed In-Line-With-Flowing-Path Tubular U-Channel-Bendable-Knife gate micro- valve is shown at 594. The construction principle, process and materials are similar to as described in FIG. 9 and 10, except that gate lever 479 is bent in U shape channel socket and it blocks flowing path straight vertically without making valve diameter or length large hence it is m-line-with-flowing-path. Internal luminal tube 475 is cut vertically straight at 476 where it will be bonded with U-channei socket as shown in 477 and it is further connected with intravascular tubular micro-actuator 593. U-channel socket is shown in bigger scale at 480, bendable gate-knife 479 is in valve closing position and its lever is pajtly in the u-channel. The function and operation is similar to the ones stated in FIGs. 9 and 10. As actuator shell physically moves from right to left (here and earlier stated left- right or right-left meaning from one position or location to the other position or location) it pushes knife gate inside u-channel thereby closing luminal path of the internal luminal tube. And when it moves from left to right it pulls out knife gate from the u-channel thereby opening internal luminal tube path and making it unobstructed.

The second additional example of Implantable Un-Obstructed In-Line-With-Flowing-Path Tubular Double-Symmetrical Pinching gate micro-valve is shown at 595. This is relatively easy to construct but with limited application and material selection. Internal luminal tube 468 is bonded with soft and flexible tube 467 which can be constructed with one or more materials from PET, Nylons, PE (poly olefins), Polyurethanes, PVC (flexible or non flexible), Silicon, Ceramics, Polyurethane, combinations of silicone with polyurethane, Elast-Eon, AV Fistula, Dacron, ePTFE, and or Procol with or without tissue-engineering, and are coated with bio-compatible materials and may also be coated with drug eluting if required. The type of drug eluting material can be selected based on its specific application, location and environment. Two hard long flat plate levers 462 and 466 are directly soldered or laser welded with actuating shell of actuator 461. Hard plates' central tensile bend force is focused at 463. At distal end of the hard plates 462 and 466 are two pinching pads 464 and 465 respectively. As actuator physically moves from left to right, it pushes hard plates 462 and 466 where its tensile bends get released and start pinching tube 467 until it is fully closed as shown in 474. Hard plates 470 and 471 push each other to opposite sides and consequently it pinches the tube 474 thereby blocking flowing path 475 and 473. In preferred embodiment another additional feature and function of this valve is that, it is added with pressure and flow sensors 600 at 468 of internal lumen of tube. When a non- fertilized egg (oocyte) or fertilized egg (zygote) or morula or blastocyste passes through the pressure and flow sensors 600 and reaches its desired location, the flexible tube 467 is pinched by hard plates 470 and 471(as shown at 474) and destroys, breaks or kills the egg or morula in order to achieve contraception. It is an embodiment of the present invention, in which non-fertilized egg (oocyte) or fertilized egg (zygote) or morula or blastocyste is sensed by means of any sensor and once it reaches its desired location, it is crushed to destroy or kill to achieve contraception. In this scheme, it will not block fallopian tube fluids ever.

The third additional example of Un-Obstructed In-Line-With-Flowing-Path Tubular balloon gate valve is shown at 596. Balloon gate valve can be constructed using several different types of balloon shape which may include, Conical Balloon, Square Balloon, Spherical Balloon, Conical/Square Balloon, Conical/Square Long Balloon, Conical/Spherical Balloon, Long Spherical Balloon, Tapered Balloon, Dog Bone Balloon, Stepped Balloon, Offset Balloon, Conical/Offset Balloon or any other geometrical or non-geometrical shape which can be produced with one or more of materials from PET, Nylons, PE (Polyolefiπs), Polyurethanes, and or PVC (flexible) or some other such materials and can be with or without tissue-engineering and are coated with bio-compatible materials and may also be coated with drugs if required. The type of drug material can be selected based on its specific application, location and environment. However, in the example, it is shown with an off-set balloon gate valve as shown in 484. Balloon gate valve consists of three components which include: (i) any type of balloon as stated above, (ii) air, gas, or fluid interconnect pipe, (iii) and pinching reservoir. Pinching reservoir 482 is bonded over stator shell 483 of the actuator. The pinching reservoir is filled with air, gas or fluid and it is connected with 485 interconnect pipe at proximal end and distal end of interconnect pipe 485 is connected with an off-set balloon 484. As actuator shell 489 physically moves (actuates) from right to left, it pinches reservoir 487 and consequently air, gas, or fluid from reservoir flow through interconnect pipe towards the off-set balloon 488 and causes it to inflate thereby blocking the lumen path 486 of internal luminal tube and acts as valve. When actuator shell physically moves (actuates) from left to right (meaning from one location to the other) it releases reservoir thereby balloon deflates and goes back to its resting position and in this way it clears the flowing path un-obstructively as shown in 481. As presented and shown in example 595, example 596 may also be added with flow and pressure sensors in order to provide similar means to achieve contraception by killing or destroying an egg(oocyte), fertilized egg (zygote), morula or blastocyste. In this scheme of preferred embodiment, the gate will remain open most of the time and let fallopian tube fluid pass through without any blocking.

FIG. 11 illustrates another additional preferred embodiment at 596 in 980 and 981 for expanding (inflating) external or outer wall or layer remotely so as to be fixed in the lumen. This part of invention mechanism can be combined in all examples of the tubular implant device with implantable micro-actuator-valve and in the tubular implant device assembly as described in FIG. 8, 9, 10, 11, and 12. The preferred embodiment of the present invention in which middle outer diameter stays small so that it could also pass through narrowed lumen comfortably and as it reaches its target location, the tubular implant device can be inflated to expand its outer diameter to be fixed tightly in the lumen path remotely or locally. In preferred embodiment, the tubular implant device 980 has two actuators 986 and 982 with single or double stator 983 as one combined actuator or two separate actuators. Tn un-installed position of the tubular implant device, when the housing tank (reservoir) 984 (which can be filled with any liquid, gas, or air whose atoms or molecules are bigger than reservoir's wall so that it can stay for a long period without any leakage and without any change in its volume) is in inflated position as shown in 980, the outer balloon 985 is in deflated position as shown in 980 thereby keeping low profile with less outer diameter thickness and holding tightly with lumen wall. As the actuator actuates (982 or 987), it moves from left to right (meaning from first position to the other), it pinches housing tank (reservoir) 989 to cause inflation (expand) balloon 988. The actuator can be triggered locally or remotely and also can be energized locally or remotely.

FIG. 12 expresses tubular lumen pressure, flow sensors and an XYZ accelerometer and motion sensors as additional embodiments of the Novel tubular implant device of the present invention. The tubular implant device 490 shows external look whereas the tubular implant device 493 shows some of internal components of the tubular implant device 490. In the preferred embodiment of the present invention, the tubular implant device 490 is installed with pressure, flow and XYZ accelerometer and motion sensors at the proximal end before gate valve at 492. Pressure and flow sensors provide tubular fluid flow and pressure information on the one hand &on the other hand, give confirmation of the egg (oocyte), fertilized egg (zygote), morula or blastocyste 495 that it has arrived and either being blocked or passed through the gate valve. When fertilized egg grows within fallopian tube, the pressure in fallopian tube exceeds and it is detected by the pressure sensor of the tubular implant device in the present invention. In a situation, for example, where the tubular implant device 490 is set for conception and pregnancy but due to some reasons fertilized egg does not pass through the tubular implant device gate during flow and pressure measurement, and where fertilized egg grows in the fallopian tube, it exerts higher pressure, hence it also gives very early warning signal and confirmation along with measurements of other specimens for possible ectopic and abnormal pregnancy that it is growing. This very important message can be taken for immediate treatment to avoid serious health and life-threatening risks. In preferred embodiment of the present invention, the tubular implant device 493 is also installed (fabricated) with micro-miniature XYZ accelerometer and motion sensor 494. Accelerometer and motion sensor 494 gives additional directional positions of the implant itself whereby fluid, gas and or material flow can be controlled due to reverse and or over-pressure caused by implant's position along with physiological measurement changes in the tube and or vessels when human body change its positions and directions (like standing, lying, walking and running etc.).

FIG. 13 illustrates the multiple implanted locations of the fallopian tube and implanted view of the tubular implant device. The 521 diagram shows female reproductive organs where two fallopian tubes 527 and 528 interconnect ovaries at first end and where their second ends interconnect with uterus. The cross-section of the fallopian tube is shown at 500. The fallopian tube wall consists of three layers: the internal mucosa (endosalpinx) at 502, the intermediate muscular layer (myosalpinx) at 501, and the outer serosa at 500, which is continuous with the peritoneum of the broad ligament and uterus, the upper margin of which is the mesosalpinx. The internal linings of the fallopian tube are shown in 503.

The fallopian tubes are paired, tubular, sero-muscular organs whose course runs medially from the cornua of the uterus toward the ovary laterally. Each tube is about 10 cm long with variations in length from 7 to 14 cm. The abdominal ostium is situated at the base of a funnel-shaped expansion of the tube, the infundibulum 1125, the circumference of which is enhanced by irregular processes called fimbriae 1 124. The ovarian 1123 fimbria is longer and more deeply grooved than the others and is closely applied to the tubal pole of the ovary. Passing medially, the infundibulum 1125 opens into the thin-walled ampulla 1126 forming more than half the length of the tube and 1 or 2 cm in outer diameter; it is succeeded by the isthmus, a round and cord-like structure constituting the medial one-third of the tube and 0.5-1 cm in outer diameter. The interstitial or conual portion of the tube continues from the isthmus through the uterine wall to empty into the uterine cavity. This segment of the tube is about 1 cm in length and 1 mm in inner diameter.

In preferred embodiment of the present invention, the tubular implant device can be placed anywhere between uterus and ovary that is from intrauteral ostium 1120 to the infundibulum 1125 of the fallopian tube and the internal luminal diameter, outer diameter and the length of the tubular implant device can vary not only because it has to match each individual female size but also because internal lumen size of the fallopian tube itself varies from beginning till end and the tubular implant device can also have bends and curves to match the physical anatomy based on the specific organ location and structure where it will be implanted. The diagram shows some examples of location of implantation at intrauteral 522, ostium of isthmus 523, between isthmus and ampulla or the beginning of ampulla 524, ampulla 525 and infundibulum 526.

A partial segment (or piece) of fallopian tube is shown at 516 without implant whereas 507 shows a partial segment (or piece) of fallopian tube with the tubular implant device 505 of the present invention. As the diagram illustrates, the internal luminal of tube before and after implant 509 and 506, the tubular implant device provides smooth and obstruction-free lumen in preferred embodiment. As can be seen from the cross-section of the tube at 501, it has much thicker muscular body and can bear the stretch-out of the tubular implant device as can be seen from the internal lumen wall 508 or 517 of the fallopian tube 507 which is stretched out both internally and externally 508 and 504 respectively which can be differentiated from fallopian tube 516 where internal lumen 517 and outer wall 508 are in resting positions.

FlG. 14 illustrates alternating luminal grafting of cut, scarred, blocked, or defective fallopian tube. Two cut or broken pieces of fallopian tube are shown at 510 and 511 for reference in 513 where the tubular implant device 514 is placed between two pieces of fallopian tube 510 and 511 and joined them using normal surgery, micro surgery, laser stitches or with surgical glue at 512. The preferred embodiment of the present invention makes an easy surgery of fallopian tube on one hand & on the other hand, stitches that caused scar on tubular wall & made lumen uneven are hidden in the outer wall of the tubular implant device, which consequently provides smooth and clear lumen to the fallopian tube and therefore provides an assistive means to infertility treatment.

Another example of the preferred embodiment of the present invention is presented at 537 where previously scarred, narrowed, plaqued, or blocked fallopian tube or vascular or intravascular can be re-claimed without risky surgery or other less successful procedures. The length of the tubular implant device 538 can be varied to substitute the length of the defected fallopian tube 536 (or vascular or intravascular) and reclaim the smooth luminal path of the fallopian tube as shown in from 539 to 540 and the cross-section of tube is shown at 534 and 535 respectively. The defected area of fallopian tube 536 is shown with cross-section at 530 where 531 is filled with scarred tissues and 533 is blocked lumen which makes the remaining lumen 532 as narrowed and after implantation of implant is reclaimed.

FIG. 15 presents further central part and primary embodiment of the present invention to illustrate prediction mechanism of menstrual cycle in contraception. In the preferred embodiment of the present invention, the tubular implant device in the first place takes over fallopian tube or vascular or intravascular lumen path; secondly, gathers key elements of internal body changes; thirdly, derives a mechanism to determine various intended and bodily natural events to make action oriented decision; fourthly, controls fallopian tube or vascular or intravascular lumen path (without any medication); and, fifthly, provides pre and post information of internal bodily changes for further possible computations and actions. In further addition, to augment and perform several other assistive or stand-alone functions and operations as described in previous and coming diagrams, descriptions, objectives, background and analysis in this entire document of the present invention, hence not limited in its application.

Fertilization is a matter of life or death. Sexual reproduction, the appropriate communication between mature and competent male and female gametes determines the generation of a new individual. This fundamental process and reproduction requires mature and competent sperm and egg so that they may fuse. Hoπnones, ion channels and temperature are key elements in the dialogue between sperm, its environment, and the egg. However, fertilization is essential for sexual reproduction and for the generation of a new individual. The hall marks of prediction mechanisms of the present invention consist in FIGs. 15, 16, 17 and 18 which are the outcomes of thorough, hectic and repeated research and experiments. The exact value and changes in human body is differr from person to person and for this very reason historical data and approximations in measurement values are considered for determining the relative each specific prediction in the present invention as preferred embodiment. However, predictions can be excluded for many other reasons which may include if a person is taking or was taking medications or drugs which directly or indirectly affect the normal menstrual cycle or in a situation where a person is having injury, neurological problems or disorder or other health problems which affect directly or indirectly normal menstrual cycle.

FIG. 15 illustrates various conclusive hormonal and temperature changes in menstruation cycle in text at 820, 821 and 822 where it is further refined in formula equations at 861 and 862 and this is presented in a simple approximation form in prediction graph 854. At the top, it shows various hormonal endomaterial histolog and temperature variations day by day of normal non-fertilized typical menstruation cycles of three months 864.

The menstruation cycle consists of three phases mainly: follicular-phase 845, ovulation 848 and luteal-phase. The beginning of menstruation cycle starts from the day it starts menstruation bleeding (often called periods meaning no sexual intercourse). This makes endomaterial histology to exit the material from the uterus lining through vagina which was prepared during previous luteal-phase for possible pregnancy to grow in the uterus. Edomaterial 863 when reaches the bottom, it finishes periods which can be determined from the day it stops menstrual bleeding. And from this point, endomaterial 847 starts rising to prepare uterus in this menstrual cycle for possible pregnancy until it reaches its peak before the end of current menstrual cycle and similarly if no pregnancy takes place, periods will be started with bleeding to mark a new cycle of the following menstruation cycle. For better clarity and understanding FIG. 15 shows consecutive three months cycles.

At hormone graph charts 838, one of the important pre-ovulatory hormone Estradiol 840 starts rising to prepare Luteinizing hormone (LH) 843 for ovulation. Once Estradiol 840 finishes its function, it starts dropping and luteinizing hormone continues to increase for ovulation to stimulate an ovulation to occur. Finally at its (LH) peak, it finishes follicular phase 845 and enteres in ovulation phase 848 and therefore causes Follicle stimulation 841 to begin which results in delivering an egg. Here, the point to be noted is that both ovaries prepare to deliver egg, but only one delivers at random in one cycle. During this time the temperature 851 in ovary and infundibulum of the fallopian tube increases significantly above isthmus section of the fallopian tube and reaches the ampulla region of the fallopian tube where egg and sperms meet for fertilization. During ovulation cycle, the second most important hormone Progesterone 844 starts to rise to prepare for fertilization and possible pregnancy. If no fertilization (sperm-egg meeting) takes place, temperature will drop slowly but will remain mid-high only due to rise in progesterone hormone 844 throughout the luteal-phase 849 and slowly drops both progesterone and temperature at the end, marking the end of menstruation cycle. This entire process will continue to repeat in second 852 and third menstrual cycle 853 and so on.

In the findings of the preferred embodiment of the present invention the prediction of Estradiol is determined based on 820, that is; as Estradiol level increases, it increases compositions of fallopian tube fluid and its cell-membrane wall secretion of Chloride Cl- and Sodium Na+ in the beginning and as it reaches peak Calcium Ca2+ and Potassium K+ increases to small degree, indicating pre-ovulation prediction until Estradiol starts decreasing after which ovulation cycle LH initiated. pH is inversely proportionate to the Estradial. As Estradiol level increases, pH starts decreasing and as Estradiol starts decreasing, pH starts rising and at LH peak it increases significantly indicating an ovulation. Estradial also causes changes in electrophysiological membrane potential, conductivity and capacitance to increase. Decrease in Estradiol affects Cl- and Na+ but it does not cause decrease in conductivity and capacitance because other hormones are initiated to remain at higher concentration. Ovulation can be determined from sharp fall of Cl- and Na+ whereas it can also be determined from sharp rise of capacitance and conductance along with changes in temperature .

In the findings of the preferred embodiment of the present invention the prediction of Progesterone is determined based on 822, that is; as ovulation takes place for fertilization, Progesterone starts increasing which causes to increase Potassium K+ and Calcium Ca2+ compositions in fallopian tube fluid and its cell-membrane wall secretion. If no fertilization took place, Potassium K+ and pH decline sharply along with capacitance indicating death of an egg. As Progesterone rises, it increases K+, pH and Ca2+ and capacitance again indicating post-ovulation. Since no fertilization happened, after which electrolytes, Temperature, capacitance and conductance decreases indicating an end of a menstrual cycle followed by periods which will start to undertake next menstrual cycle.

In the findings of the preferred embodiment of the present invention in which the measurement of the Temperature changes helps to determine various events based on 821, that is; both Estradiol and Progesterone measurements require measurement of Temperature together. During ovulation, temperature and Potassium K+ in Fallopian Tube rises which indicate ovulation to occur. When sperms are present in the fallopian tubes, it causes changes in fallopian tube temperature for the storage of sperms. Mature Sperms use heat sensors to find an egg for fertilization. The place where egg resides has higher temperature. Both sperms' and egg's presence can be detected using change in fallopian tube temperature along with other electrolytes. If fertilization took place, it further rises Temperature, Potassium, Calcium, and pH. If no fertilization happened, Temperature, and Potassium K+, decline, indicating death of an egg, but it rises again as progesterone rises.

The preferred embodiment of the present invention brings these findings in two equations: 861 and 862 to measuring delta change in hormones level of Estradial and Progesterone respectively and therefore integral part of the present invention that is;

In the preferred embodiment of the present invention, the delta change in estradiol 861 is such that change in estradiol induces change in chloride Cl- and Sodium Na+ ion channels to higher degree where as pH is inversely proportionate to the Estradiol, as Estradiol level increases, pH starts decreasing and as Estradiol starts decreasing, pH starts rising and at LH peak it increases significantly indicating an ovulation, however, estradiol cause less in Ca2+ and Potassium K+ changes, which can also be determined further by simply measuring delta change in overall cell membrane conductance and capacitance potentials while taking in consideration, the follicular specific menstrual phase. In the preferred embodiment of the present invention, the delta change in progesterone 862 is such that change in progesterone induces change in potassium K+ Calcium Ca2+ and pH ion channels to higher degree but less in Cl- and Na+ which can be determined further by simply measuring delta change in temperature, overall cell membrane voltage and capacitance potentials while taking in consideration luteal specific menstrual phase and during pregnancy and abnormalities.

In the preferred embodiment of the present invention, the ovulation is derived from Temperature, ion channels, conductance, capacitance, voltage potentials and in considerations of estradiol and progesterone hormones.

Findings and derivations of 820, 821, 822 and 861 and 862 of the preferred embodiment of the present invention are drawn in graphical chart 854. The vertical axis of the chart represented in low, medium, medium high and high values whereas horizontal axis is marked with each day of the menstrual cycle. The first reference prediction of the menstrual cycle is determined at 856 by measuring estradiol or changes in above stated ions and or changes in cell membrane potential values where the values start rising consecutively above average mean value of previous days, thus indicating pre-ovulation marker before 4 to 5 days of ovulation. The second reference prediction of the menstrual cycle is determined at 857 by measuring estradiol value from its peak and then fall after which temperature takes immediate rise along with other measuring values confirming the ovulation. The third prediction 858 relates to determine the fertilization (conception) or contraception by sharp fall of the derived graph chart measuring temperature, ions and cell membrane potential as stated above in 820, 821, and 822. The fourth prediction of the menstrual cycle is determined at 589 where values of ions, temperature and cell membrane potential rises as stated in 821, and 822 while in consideration that 820 has already taken place indicating progesterone level that safe (no chance of becoming pregnant during sexual intercourse) window is beginning and that marked as post-ovulation. The fifth prediction of the menstrual cycle is determined at 560 where all values from hormones, ions and cell membrane potentials approach its base line at the beginning of the current cycle followed be a beginning of periods or bleeding indicating the end of current menstruation cycle and the beginning of the next menstruation cycle.

FIG. 16 presents further central part and primary preferred embodiment of the present invention to illustrate prediction mechanism plotted with the tubular implant device electrodes and presented with flow-chart algorithms indicating how they interact with corresponding predictions in FIG. 15. As illustrated in FIG. 12, the tubular implant device is installed with flow and pressure sensors which enhance the activity measurements and added more precise prediction and control. In preferred embodiment of the present invention, uncountable (just for the sake of saying), in fact hundreds of such algorithms can be derived from the novel tubular implant device based on its place where it will be implanted and in environment it will measure the specimens and in place or object where it will be implanted and required to do specific task and expected results out of the tubular implant device. Therefore the application of the novel tubular implant device is not limited in fallopian tube application for contraception, conception, pregnancy and so on.

For the sake of clarity, the tubular implant device 885 is presented with two groups of electrodes where each group consists of three electrodes. In FIG. 1, the tubular implant device 002 is presented with two groups of electrodes and each group consists of two electrodes. In the preferred embodiment of the present invention, the tubular implant device can be configured with one, two or more electrode groups and each group can consist of one, two or more electrodes depending on determination of required specimen/s and or measuring variable/s.

Two electrodes 827 and 828 are measuring electrodes whose reference electrode is 829. These electrodes can be configured with both single or multiple ions select measuring electrode or one ion-select and one cell membrane electrophysiology potential measuring or both electrodes for cell membrane electrophysiology potential measurement for conductance, voltage potential, and or capacitance where they are connected with electronic interface 834 to measure specimen/s 884. Similarly, the second electrode group consists of 833 and 832 with its reference electrode 831. These electrodes can be configured similarly as presented in group one (or first), except that they configured for different specimen/s other than first thereby adding more measurement variables for intended applications. Electrodes 832 and 833 are connected with electronic interface to measure specimen/s 889. Both first and second groups of electrodes measurements are considered along with temperature and it is through electrode 830 measuring specimens 891, from its outer layer whereas temperature measurement in the present invention is a primary measuring variable. In addition, the tubular implant device 885 is instrumented with lumen flow and pressure sensor 836 increasing accuracy in computing measurement in the present invention whereas pressure and flow sensor adds its own physical measurement of moving object through the internal lumen of the tubular implant device 885.

In the preferred embodiment of the present invention, first group of electrodes is preferred to record estradiol specific specimens whereas second group of electrodes is preferred to record progesterone specific specimens in current application example which fallopian tube implant for contraception, conception, pregnancy and so on.

In the preferred embodiment of the present invention, the first flow chart algorithm mechanism starts from pre-ovulating prediction 930 which from the very beginning takes into account that it is a new menstruation cycle and the previous cycle has ended which takes the feedback from watch-dog algorithm 887. Specimen values from 884 and 891 are gathered and computed in accordance with reference from 856 and compares new determined values in consideration of data from last menstruation cycles so that it could be adjusted according to individual person. In case where data from previous menstruation cycle is not available or current cycle is the first measuring cycle, then simply make a manual data entry that it's a first menstruation cycle and that today was the first day of menstruation cycle so that algorithm measure at least once daily or multiple times or as per pre-program to establish individual's personal data peaks. Considering first menstruation cycle, it takes the reading from 884 and 891 specimens and computes in accordance with 856 as how daily changes on specimens and how they are rising their values marking the pre-ovulation prediction once it matches sequence as 820, 821, and 822 references. The application of this prediction is that if user is on the contraception desire, the tubular implant device will close its internal lumen path thereby isolating sperms and egg meeting to avoid conception or fertilization. And if the user is on the conception or desires pregnancy, she can start preparing for this to happen and make sure that she had intercourse prior and during ovulation for maximum success.

In the preferred embodiment of the present invention, the second flow chart algorithm mechanism is to determine the presence of sperms 824, whether during intercourse ejaculation or insemination sperms have reached the fallopian tube for storage. This determination begins with manual data entry followed by measuring changes in ions, electrophysiology of cell membrane, temperature and flow sensor. When sperms pass through the tubular implant device lumen, at first flow sensor record changes in its flow sensor (if the tubular implant device is implanted near the uterus), secondly when sperms enter into the fallopian tube the temperature falls so that sperms can store and survive for long, indicating the presence of sperms and if sperm dies, the temperature goes back in its average value where it was before the presence of sperms, and thirdly when sperms are present in the fallopian tube electrolytes rise to small degree above compare to the values from 884 and 889 specimens and when sperms die, values of specimens can be compared again with historical value at the point where they were without the presence of sperms.

In the preferred embodiment of the present invention, the third flow chart algorithm mechanism is to determine confirmation of ovulation 892 ready to be fertilized. This is determined during the on-going course of menstruation cycle's data recording and with clear specimen measurement values from 884, 891 and 889 respectively. The measured values are compared with previous data if available and then measure according to the changes in 820, 821 and 822 and then compare with graphical chart reference values at 857.

In the preferred embodiment of the present invention, the fourth flow chart algorithm mechanism is to determine confirmation of fertilization (conception) or the death of an egg (contraception) 890. This is determined first by considering whether the sperms are present in the fallopian tube as in case of 824, secondly consideration from 892 that egg has been delivered in the fallopian tube, and thirdly by measuring specimens from 891 and 889. The measured values are analyzed in accordance with 820, 821 and 822, along with 880_? 881 and 882 after which it compares with reference value 827 from graphical chart 924 and finally derived the confirmation for either fertilization (conception) has taken place or the confirmation of a death of an egg (contraception).

In the preferred embodiment of the present invention, the fifth flow chart algorithm mechanism is to determine the confirmation of fertilized egg implantation or simply a post- ovulation marker at 886. This is determined first by considering the result values from algorithm 890 whether the menstruation cycle is in conception state or in contraception, secondly specimens values from 884, 891 and 889 are measured and analyzed according to 820, 821, 822, 880, 881 and 882 and further compare values in both 859 and 928 respectively. If it was in contraceptive state, it compares values with 859 to confirm the post-ovulation marker without pregnancy and if the egg was fertilized in 890, it compare the specimens with reference to chart 928 and then measures the pressure and flow sensors 836 values if fertilized egg has passed through the tubular implant device 885's lumen or it is still within the fallopian tube.

In the preferred embodiment of the present invention, the sixth flow chart algorithm mechanism is to continuously watch the entire menstruation cycle in every possible detectable condition as a watch-dog 887 which are derived from above algorithms and all those possible conditions which can also be derived based on several measurable variables from the tubular implant device's electrodes and sensors and conditions from existing algorithms and entering manual key conditions and inputs are not therefore limiting the application of the present invention. One way or the other, the female would know at the end of the menstruation cycle, if she is having periods or missing periods out of sexual intercourse and or likely to proceed for a pregnancy. In preferred embodiment of the present invention, most critical factors to watch are not just the answer of yes or no about pregnancy but the state and health of menstruation cycle and health of pregnancy, continuously in time before it is too late. FIG. 18 covers some of the abnormalities which can be watched and determined very easily when comparing measured specimens and sensor values with FIG. 15, FIG. 17, and FIG. 18, however, given the facts through manual data entry along with, several related conditions, they can also be monitored. This minimizes drastically the rate of miscarriages, fallopian tube ruptures due to ectopic pregnancy, abnormalities of pregnancy and possible course of self or natural abortion where early treatment can reverse these conditions and or more importantly minimizes the risks of serious health risks. Furthermore, if a person knows within first 48 hours or few days of egg fertilization where egg is still dividing and in the morula stage, she can proceed with very early stage of abortion which is acceptable in many religions and, above all, carries very little and manageable complications and risks.

FIG. 16 illustrates yet further central piece of the invention to express prediction mechanism of menstrual cycles in conception (pregnancy) and continuation of pregnancy. The graph chart 934 presents a first trimester's normal and healthy pregnancy with day-by-day hormonal, temperature and endomaterial histology changes of pregnancy. The first follicular phase 900 of the first menstruation cycle 894 is similar with FIG.15's first follicular phase 845 and changes in histology, hormones and temperature take place in accordance with a normal healthy cycle. However, ovulation 902 and luteal-leutinizing hormone 904 peak causing rising follicle stimulation which releases an egg from ovary and it is caught by infundibulum of fallopian tube and finally rolled-over at ampulla, the likely place where it meets with sperm for fertilization. When ovary delivers an egg (or oocyte), the temperature takes a sharp rise as it can be seen at 905 and it takes little drop afterwards but remains high till the life of an egg and waiting to be fertilized. When egg is present in the ampulla, the temperature is in higher state in the ampulla region of fallopian tube to keep warm and cozy place for fertilization. Sperms are stored in isthmus region of the fallopian tube waiting for an egg for fertilization. Sperms use heat sensors to sense if the egg has arrived in the ampulla, and if they sense that egg has arrived in the ampulla of the fallopian tube because of temperature difference, they march towards ampulla to meet with an egg. Only the successful mature sperms which arrive at ampulla will have possibilities to enter or penetrate into the egg. The egg carries a negative charge and sperm carries a positive charge. A positive charge moves or is attracted towards negative charge. Before egg is fertilized, sperms encircle around the egg (oocyte) in an anti-clockwise few rounds and try to penetrate into the egg (oocyte). When one sperm is able to penetrate into the egg successfully, (where both negative and positive charge carriers meet), a fertilization process takes place. This meeting of sperm with egg causes egg to become positive charge from negative, therefore it immediately starts pushing and repelling away other positive charge carrier sperms, which slowly die because of higher temperature in ampulla region of the fallopian tube.

There are some conflicting theories which manually measure and record several bodily changes after being pregnant to estimate whether the pregnancy is because of an "X" chromosome carrier sperm (a baby girl) or a "Y" chromosome carrier sperm (a baby boy). And measuring manually these complex parameters is very difficult to note and maintain. The preferred embodiment of the present invention is to derive X and Y chromosome specific predictions using Temperature, hormonal changes, ions and cell membrane electrophysiology along with manual data entry of key symptoms and condition and to inform female whether the newcomer is a baby girl or a baby boy in the present invention using tubular implant device and smart remote control with least possible manual interaction.

When egg is fertilized (becomes 2ygote), the temperature takes small rise again which is also contributed with the rise of progesterone as it can be seen in 906 and 912. The estradiol 909 after taking small rise, continues to drop in luteal-phase 899 until it reaches its low base level indicating normal and healthy estradiol hormone. As the egg (zygote) continues to divide, temperature stays at higher level and when it reaches early blastocyst stage, it slowly takes the route towards the uterus cavity for implantation. At this stage progesterone continues to rise whereas temperature takes slowly small drop, but on average stays mid- high with some small ups and downs and considered stable. As the pregnancy approaches the next menstruation cycle 895, both endometrial and progesterone continue to rise whereas temperature stays at stable mid-high. Because pregnancy is continuously growing from blastocyst to embryo stage, it misses the cyclical periods which is the presentation of external symptom where it enters in the second month of pregnancy. Since the pregnancy is growing therefore it skips menstruation bleeding periods and also estradiol level stays lower and no follicular cycle will take place for an ovulation which is actually suspended till the end of the pregnancy. Endometrial 921 and progesterone 914 continue to rise as embryo is growing to become fetus in coming weeks whereas temperature continues to stay mid-high. These changes would continue even in the third menstruation cycle or third month of pregnancy, as shown in 896. At the end of the third month, both endometrial and progesterone continue to grow as shown in 922 and 915 respectively and temperature 908 also stays steady at mid-high, whereas progesterone and Leutinizing hormone stay low indicating a healthy pregnancy and pregnancy continues towards trimester, as shown in 920 the size of the uterus is traditionally described via comparison with its size at different stages of pregnancy. The size of the uterus can be ascertained via bimanual palpation a known-pregnant uterus is described as plum-sized; 6 week pregnant uterus as egg-sized; 8 week uterus as the size of a small orange; a 10 week uterus is the size of a large orange. After 12 weeks of pregnancy the fundus of the uterus is palpable above the symphysis pubis. It reaches the umbilicus by the 20-22 weeks, and finally ceases to ascend at 36-38¹¹¹ week (uterine fundus at about the level of the xiphisternum).

The above described chart 934 is expressed in text equation in regard to estradiol, progesterone and temperature changes in 880, 882 and 881 respectively.

In the findings of the preferred embodiment of the present invention, as Estradiol level increases, it increases compositions of Fallopian Tube fluid and its cell-membrane wall secretion of Chloride Cl- and Sodium Na+ in the beginning and as it reaches peak Calcium Ca2+ and Potassium K+ it increases to small degree, indicating pre-ovulation prediction until Estradiol starts decreasing after which Ovulation cycle LH is initiated. pH is inversely proportionate to the Estradiol. As Estradiol level increases, pH starts decreasing and as Estradiol starts decreasing, pH starts rising and at LH peak it increases significantly indicating an ovulation. Estradiol also causes changes in electrophysiological membrane potential, conductivity and capacitance to increase. Decrease in Estradiol causes Cl- and Na+ but it does not cause decrease in conductivity and capacitance because other hormones are initiated to remain at higher concentration. Ovulation can be measured to determine with the sharp fall of Cl- and Na+ whereas it can also be measured with sharp rise of capacitance and conductance along with changes in temperature . In the findings of another preferred embodiment of the present invention, as ovulation takes place for fertilization, Progesterone starts increasing which causes increase in Temperature, Potassium K+ and Calcium Ca2+ compositions in Fallopian Tube Fluid and its cell- membrane wall secretion. If egg fertilizes successfully, it can be measured to determine the value of Potassium K+, Ca2+ (to some degree), and pH which continue to increase without any sharp fall and capacitance stays high without any sharp fall. As fertilized ovum/cell continue to divide, Progesterone continues to rise and causes to increase K+, Ca2+ and pH which consequently cause capacitance and conductance to stay high to some more degree, indicating growing pregnancy with success.

In the findings of yet further embodiment of the present invention, both Estradiol and Progesterone measurements require primary measurement of Temperature together. During ovulation, temperature and Potassium K+ in Fallopian Tube rises which indicates ovulation to occur. When sperms are present in the fallopian tubes, it causes changes in fallopian tube temperature for the storage of sperms. Mature sperms use heat sensors to find an egg for fertilization. The place where egg resides has higher temperature. Both sperm's and egg's presence can be detected using change in fallopian tube temperature along with other electrolytes. If fertilization takes place, it further rises Temperature and Potassium, and to some degree Ca2+ and pH. As the cell continue to divide Temperature, Potassium, Ca2+, and pH stay high and Capacitance and potential also stay high indicating pregnancy continues growing. Here monthly menstrual cycle misses. And pregnancy continues in the next month.

These findings, predictions and measurement techniques of the preferred embodiment of the present invention are drawn in the graphical chart at 924. The first prediction is marked and determined at 925 when estradiol level rises above average low indicating a pre-ovulation prediction. The second prediction is marked and determined at 926, when temperature, potassium and some degree of calcium and pH ions and electrophysiology measurements rise indicating an ovulation has occurred. The third prediction is marked and determined at 927 when temperature continues at high and mid-high stage and potassium, calcium and pH are also in high state and there is no sudden fall whereas capacitance also continues to stay high thus indicating a fertilization has taken place. The fourth prediction is marked and determined at 928 where it maintains measurement values of 927 with small drop but continues to stay mid-high indicating pregnancy continues in the post ovulation. The fifth prediction is marked and determined at 929 at the close of the cycle and gives similar findings as in 928 indicating continuation of the pregnancy as well as health of the pregnancy. Individual measurement of temperature, ions, and electrophysiology can give more specific understanding and prediction of the health of the pregnancy in which any thing abnormal can be identified quickly in time before it is too late.

FIG. 17 illustrates another further central piece of the invention to express prediction mechanism of menstrual cycles in post conception and abnormalities of the pregnancy. This prediction mechanism is more complex than a measuring and predicting normal contraception and conception cycle of the menstruation. As presented in FIG. 16 at pregnancy watch-dog algorithm 887, it not only takes the current measurements of the specimens but also cross-checks every variables from preceding values and historical data, events and its trends based on point of time where the pregnancy is situated. The chart graph 936 is not a typical chart but it is presented as a theological clarity, however, actual events and measuring values can be quite drastic or may be less drastic as shown in the chart graph 936. However, in any case of abnormalities, and fluctuation, the tubular implant device with smart remote control device, is designed to predict the most of abnormalities if not all. Because all invasive measurements right at the place (fallopian tube) and near the place (uterus) where all events of conception, implantation and pregnancy are taking place, are taken into consideration with historical changes as they occur and manual data entry of ongoing symptoms and conditions of the person whose pregnancy cycle is being watched (monitored).

The menstruation cycle of first month of the trimester 937 is very similar to 894 of a normal healthy pregnancy except that measurement values in the later part of first luteal-phase 899 does not show higher values of endometrial and progesterone as it is supposed to be which can give some question mark of the health of current pregnancy, however, it may be very early to make decision. If blastocyst did not implant in the uterus cavity which can be measured in the present invention for a possible stage of early ectopic pregnancy while considering other manual data about the health and age factors etc. In ectopic pregnancy, progesterone could not rise as it is supposed to be whereas temperature starts taking rise and up, and pressure in the fallopian tube builds up abnormally indicating fallopian tube is in discomfort and oedamatous. Nevertheless, if blastocyst did manage to implant in the uterus cavity but due to cell or chromosome or other defects and or abnormalities that hinder the healthy growth of pregnancy, the hormones, ions, electrophysiology of cell membrane and temperature immediately reflect such abnormalities and therefore can be measured, derived and predicted along with manual data entry of related symptoms and conditions of the female. This can be seen clearly where such abnormal values presented in the second month of pregnancy cycle 938 in terms of fluctuations or abnormal rise and fall of temperature 944, progesterone 952 and endometrial at 958 are showing such abnormal behavior which can be clearly identified with historical values, trends and added symptoms and conditions. Any miscarriage resulting from other factors which include physical injury or trauma, side- effect of drug, direct reaction of food intake, or sudden neurological change, where all these parameters cannot be predicted. Therefore impact on pregnancy is very sudden which may lead to sudden miscarriage. However, other internal slowly approaching such abnormalities can be detected and predicted before they become fate of the intended pregnancy which can be reversed if treated in early stage. This helps in avoiding miscarriages and serves one of the prime objectives of the present invention. If ectopic pregnancy is growing in the isthmus region of fallopian tube, changes shown in 944, 952 and 958 with symptoms and conditions, could be in higher fluctuations than they presented in the second month of pregnancy and quickly get worse because isthmus region of the fallopian tube is narrowed and in smaller diameter and cannot sustain or handle embryo growth and very likely to burst in 6 to 8 weeks or shows abnormal signs as early as six weeks of pregnancy if no immediate medical assistance is taken; whereas ampulla region of the fallopian tube is bigger and thicker in diameter and can sustain and handle even longer period and begins to show signs and symptoms in the later part of the second month of pregnancy which gets worst in the third month 939 as presented in 945, 953, 949 and 959. In case it did not proceed for miscarriage, ectopic rupture in the first half of the third month cycle, it can be worst in the second half of the third month which can be evident at 945 and 946.

The above described graphical chart is derived with text algorithm for specific specimen/s measurements which include 920, 921, and 922 as follows.

In the findings of prediction measurements of the preferred embodiments of the present invention, as Estradiol level increases, it increases compositions of Fallopian Tube fluid and its cell-membrane wall secretion of Chloride Cl- and Sodium Na+ in the beginning and as it reaches peak Calcium Ca+2 and Potassium K+ increase to small degree indicating pre- ovulation prediction until Estradiol starts decreasing after which ovulation cycle is initiated. pH is inversely proportionate to the Estradiol. As Estradiol level increases, pH starts decreasing and as Estradiol starts decreasing, pH starts rising and at LH peak it increases significantly indicating an ovulation. Estradiol also causes changes in electrophysiological membrane potential, conductivity and capacitance to increase. But it does not cause decrease in conductivity and capacitance because other hormones are initiated to increase. Decrease in Estradiol effects Cl- and Na+ but it does not cause decrease in conductivity and capacitance because other hormones initiated to remain at higher concentration. Ovulation can be determined with the sharp fall of Cl- and Na+ whereas it can also be determined from sharp rise of capacitance and conductance along with changes in temperature. After fertilization, Estradiol stays stable at low level. But if pregnancy is abnormal or ectopic, it starts rising or fluctuate at a very slow pace, although its change is not significant. However, during abnormal or ectopic pregnancy, electrolytes in tubal fluid, temperature and consequently conductivity and capacitance also fluctuate therefore give early warning. In this situation, extreme dehydration, repetitive nausea, repetitive heavy bleeding, pain and fever take place repeatedly.

In the findings of prediction measurements of the preferred embodiments of the present invention, as ovulation takes place for fertilization, Progesterone starts increasing which causes to increase Potassium K+ and Calcium Ca2+ compositions in Fallopian Tube Fluid and its cell-membrane wall secretion. If egg fertilizes successfully, it can be measured to determine the value of Potassium K+, and Ca2+ (to some degree) which continue to increase without any sharp fall and capacitance stays high without any sharp fall. As fertilized ovum/cell continues to divide, Progesterone continues to rise and causes K+ capacitance and conductance to stay high to some more degree. But, if pregnancy is abnormal or ectopic, Progesterone either does not increase or decline which can be noticed clearly. Consequently, electrolytes K+, Ca2+, pH, Na+, Cl- in tubal fluid and temperature fluctuate which also causes fluctuation in potentials, conductivity and capacitance to indicate early warning. In this situation, extreme dehydration, nausea, bleeding, pain and fever take place repeatedly.

In the findings of prediction measurements of the preferred embodiments of the present invention, both Estradiol and Progesterone measurements require primary measurement of temperature together. During ovulation, temperature and Potassium K+ in the fallopian tube rises which indicates ovulation to occur. Sperm uses heat sensor to find an egg for fertilization. If fertilization takes place, it further rises temperature and Potassium. As cell continues to divide and finally implant in the uterus, Temperature, Potassium, Calcium, pH and Capacitance stays high indicating pregnancy continues and growing. Here menstrual cycle also misses periods. If pregnancy is abnormal or ectopic or miscarriage is to take place, temperature fluctuates and even causes occasional fever. In this situation, extreme dehydration, nausea, bleeding, pain and fever take place repeatedly.

FIG. 19 illustrates the schematic of the preferred embodiment of the present invention to deploy the fallopian tube implant with additional battery. The preferred embodiment of the present invention is that teen-aged girls in developing and less developed or third world countries have no education, their mind-set not mature to handle puberty and they may not be able to control their menstruation cycle, do not understand or not capable to handle and manage the complications and responsibility to become pregnant and mother, and may not even have command and rights towards their own life or those early aged teen girls in A2006/000737

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developed countries who do not have any plan to become pregnant and do not want to bother with smart remote control are the candidates of this additional embodiment of the invention which is added with additional re-chargeable battery with the tubular implant device and the tubular implant device is implanted at intrauterine ostium of the uterus where additional battery can be placed in the uterus as shown in 664. This eliminates the need of any un-needed medication, abortion, medicated implant, or permanently loosing reproductive organs. The preferred embodiment of the present invention assists to deal with teen-aged post-pregnancy and post-delivery risks, issues and complications.

The implant delivery device 641 is equipped with hystroscope 642 and implant delivery catheter 644 is attached with implant delivery device with union at 643. Distal end of the implant delivery catheter 645 is shown in larger view at 646, where the tubular implant device 650 is housed in the distal end of the catheter 649. The battery carrier belly 657 is connected with implant delivery catheter and it is closed at the bottom but has opening 654 for battery. The battery carrier belly can be made with one or more materials from PET, Nylons, PE (poly olefins), Polyurethanes, PVC (flexible), Silicon, Polyurethane, combinations of silicone with polyurethane, and or Elast-Eon and coated with biocompatible materials. The Battery 655 is concealed with soft, stretchable and flexible material from one or more of PET, Nylons, PE (poly olefins), Polyurethanes, PVC (flexible), Silicon, Polyurethane, combinations of silicone with polyurethane, and or Elast-Eon and coated with bio-compatible materials. It may also be coated with drugs. This soft, stretchable and flexible cap is covered around battery 655, battery cable 653 and up to the cable-implant device connector 651. The longitudinal gap 650 allows battery cable 653 to freely get delivered in the intrauterine ostium during implantation and as implant is coming out of implant delivery catheter by implant delivery tube, the battery cable 653 also acts like a tiny rope which lifts (or pull) the battery to come out from battery carrier belly. After the implantation of the tubular implant devices, both tubular implant devices are in the fallopian tube while their additional batteries are hanging in the uterus as shown in larger view at 658 for clarity.

FIG. 20 illustrates the smart remote control device and alternative peripheral interface device. The preferred embodiment of the present invention provide additional hand tool for female not only to see and read several menstruation changes but also to control tubular implant devices implanted in her fallopian tubes, take full charge of their choices and manage any abnormalities or warnings before they become serious or even life threatening and even able to run more updated programs with more features, functions, predictions and evaluations as they become available time to time. The smart remote control device can be built in several different combinations from merely simple remote control gadget without display screen to sophisticated device with operating systems and several personal management organizer programs may be added with primary functions of the present invention. So that users from less developed countries should be able to use the present invention even if they have no educational background but at least be able to use TV remote control. Simple on/off, contraception and conception control buttons with LED lights and graphics representation about each button and pregnancy status warning lights in green, yellow and red to help them to seek immediate medical consultation. Furthermore it has battery charger button, user can charge implants battery and check the status of battery power or charge with light indications. Through its gender prediction algorithm, the remote control can also give signal of baby girl or baby boy. The preferred embodiment of the present invention in which smart remote device can also be as sophisticated as Personal Digital Assistance (PDA) and can run with off-the-shelf operating system along with its primary communication hardware. This sophistication is not only in hardware, but also in various powerful and advanced diagnostic and analysis software to give more user control to manage tubular implant devices and also compute and determine several other female health and medical problems. The smart remote device is built with dual password protection, one for husband and one for wife to choose between contraception and conception so that both husband and wife make agreeable decision in any selection thus fulfills not only some religion and cultural obligations and traditions but also give mutual respect, understanding for bearing very important responsibility.

Smart mobile phones are replacing PDAs with PDA like features and powers or it should instead of be saying that PDAs are having built-in mobile phone with wireless internet, camera, blue-tooth, multimedia and other new exciting hardware and software functionalities. In order to compliment use of these new PDA, smart phones or other such devices, the present invention's preferred embodiment provide Smart Peripheral Adapter which can be interfaced with any PDA, smart phone, smart terminal, personal computer or notebooks etc. The smart peripheral adapter runs with its software over these general purpose digital consumer products and provides similar or better functions and operations as it provides with its smart remote control device. As stated in FIG. 1 and FIG. 16, in the preferred embodiment of the present invention, the tubular implant device augment and assist researchers, pharmaceuticals, In-Vitro-Fertilization professionals, obstetricians, gynaecologists and practitioners to manage and treat their patients with more effective findings, and impact of treatments and behavior of specific medications and its impact. These gadgets when connected with wireless internet or have personal computer interface where their daily or periodic data can be downloaded for easy and simple statistical data analysis enhance the much broader applications and preferred embodiments of the present invention.

Smart remote control device 681 in FIG. 20 having inductive power antenna 682 and human implantable wireless communication transceiver antenna 683 together energizes inductive power to initialize and charge the tubular implant devices and to intercommunicate with the tubular implant device to retrieve various measured data and to give command for intended operation from and to the tubular implant device. Two additional inductive power charging coils 700 and 701 for right and left tubular implant devices respectively to charge its corresponding implant batteries. In preferred embodiment of the present invention, these charging coils can be placed just below or near the underwear or just next to their each corresponding fallopian tube place where implants are implanted while remote control can be place in the pocket or wear in the neck like a necklace so that batteries of tubular implant devices get charge while user may continue its other activities. Smart remote device is a battery power, whose power can be recharged as most of such gadgets provide such feature along with power save management features. Smart remote device 681 can upload or down load data and software and therefore can also be able to communicate using infrared communication as most hand gadgets are built with infrared communication without being physical connection through cable. Display screen 685 can be of any type as rapid change in display technology adds new features, flexibility and functionalities. The display screen may also be with screen touch grid, where a stylus pen or handwrite tools can simplify write over the display screen without using keyboard. The text message 686 is merely a simple example to present most simple information, however, the smart remote device gives full detail and graphical presentation of data and control mechanism of not only measured data after computation but also it shows various graphical analysis and charts etc. LED sign lights 687 are for user who cannot ready text they can be well informed through these lights. Mini joy stick 689 add information control mouse which allows user to just use this mouse along with its control keys 688 which functions with its mini joy sticks. Regular keyboard 690 with decimal and alphabetic digits can be marked with several different languages with display screen as just shown in 686. USB, serial interface, or Bluetooth interface 691makes physical interconnection with other digital devices.

Smart peripheral adapter 692 adds additional embodiments of the present invention and not only minimizes cost but also give user comfort and ease of operation. This gives user to carry one device along with PDA, smart phone or such hand gadget devices, which has almost all personal devices, features, and functionalities of pocket computer including, USB, serial and Bluetooth device interface is shown at 693. Inductive power coil at 695 provide similar feature and functionalities as shown and discussed in 682. Implantable medical wireless transceiver is shown in 694 and smart peripheral adapter can also interconnect with inductive charging coil as presented the FIG. 20. Hardware interface connector 693 can be placed at any of its compatible digital consumer PDAs or gadget's interface port and its operations software can be loaded in it for function and operations. PDA device 696 with its styles pen 697 and consumer wireless communication antenna is at 699 is shown to present an example in which smart peripheral is interfaced at 698 and perform similar and added features functions and operations.

FIG. 21 is a block diagram of electronic control blocks as part of the Novel smart remote- control device and alternative smart remote peripheral adapter for Novel tubular implant device. As presented and described in FIG. 20, smart remote control device can be built as independent device from very simple to very sophisticated form where it shows its internal electronics block diagram in 787; and a small and sleek smart remote peripheral adapter as a slave which can be connected with any master digital computing device PDA, PC, Notebook or other such digital devices where it can be used with software running in master computing devices. The internal electronic block diagram is shown in 778.

Electronic block diagram 787 of independent smart remote control device can be built with any simple to sophisticated microcontroller or all in one microprocessor which not only has built-in analog and digital signal processing but also carries most of peripheral, communication, display, clock, power, keyboard and other data interface components and also has large sufficient ROM, Flash, and RAM memory for specific application. However capacity of ROM, Flash, and RAM memory size can also be expanded as required in specific application.

The block diagram shows that at the center is a micro controller 761 which takes full control of entire internal data processing control and program flow. The display device 762 gives single or multiple language text and graphics in low to high resolution from black and white to color display with or without touch screen grid which allows easy human interface. The internal electronic device has medical implantable grade wireless transceiver 746 and receive and broadcast antenna 763 ranging within medical grade implant device regulation. An inductive power antenna or transducer 777 causes magnetic induction in the coil of the tubular implant device to induce magnetic power to operate and charge the tubular implant device. Wireless antenna 763 can be built as a separate antenna in device or it can be built with inductive power coil 777. Inductive power coil is driven by a power amplifier 776. The function generator 775 controlled by micro controller, generates oscillation frequency for inductive power antenna. Power amplifier also interfaces with inductive power charging coil pads 789 and 790 respectively to charge battery of the tubular implant devices for a longer period. The heart of a smart remote control device is run and governed by its BIOS (basic input output system/software), which is stored in ROM 768 and application program software in Flash memory 767. Flash memory 767 also saves historical menstruation data information, user's personal ID data and other health conditions, signs and symptoms details. Application software of the smart remote control device can be from simple control and data analysis to complex diagnostic software and data analysis. As new technology of memory keeps upgrading and inventing, therefore memory in the present remote control device is not limited and can be built with any type of memories to enhance its function and operation. The device is provided with sufficient RAM memory 769 where it saves temporary data which is required to be used by micro controller and its program application to perform various computing and controlling tasks. The electronic board of smart remote control device has LED or other light emitting devices for indication purpose, where display device is not built for reasons simplicity or cost, or for the specific type of user in order to keep simplicity.

Similarly keyboard 771 can be with a few numeric keys along with some straight forward control keys or a full blown keyboard specific to the hand-held devices can be implemented for advanced and sophisticated user and applications. The smart remote control device can be directly interfaced with cable or through infrared transceiver interface 773 with external computing and data processing devices or medical equipments 772 where data and software applications can be up and downloaded. Smart remote control device is also built with 3-D joystick for easy data and screen display scrolling and roll-over pointing device manoeuvring for easy program selection across display screen. As with most hand-held devices, the smart remote control device is built with blue-tooth or other emerging transceiver device 765 and its antenna 766 for wireless data communication where device can up and download data and application programs.

FIG. 21 also presents a small and sleek smart remote peripheral adapter as a slave which can be connected with any master digital computing device. The internal electronic block diagram is shown in 778 which can be built with ultra small foot print micro controller 779 with built-in ROM, RAM and Flash memory along with other peripheral and data interface components. Function generator 784 generates oscillation as instructed by micro controller 779 through its master digital device's commands and instructions. Power amplifier 783 amplifies oscillation frequency to drive inductive power transmitter coil 782 to cause inductive power coupling for the tubular implant device. Implantable medical grade implant wireless transceiver controller 780, interfaced with micro controller 779, receives and transmits data from and to the tubular implant device through antenna 781 which can be built either separately or with inductive coil 782. Power amplifier 783 also interconnects with inductive power charging coil pads 791 and 792 respectively. Micro controller 779 is interfaced with peripheral data interface USB or Bluetooth controller 785 which physically interconnects smart peripheral remote control adapter with master device. As new peripheral data interfaces are being developed and enhanced, the smart peripheral remote adapter can be interfaced with any available interface device and not limited to just USB and or Bluetooth.

FIG. 22 is a block diagram of electronic control circuits of the Novel fallopian tube and or vascular and or intravascular tubular implant device. In the preferred embodiment of the present invention, the heart of the tubular implant device's control and operation lies in its semiconductor electronic control blocks (chip/s) along with electrodes as presented in FIG. 22, whereas one of the important considerations lies in its construction in semiconductor process technology to build it in ultra small miniaturized longitudinal packaging using nano-scale gate processing technology. All or most of building blocks can also be built in System-on-Chip (SoC) methodology in longer rectangular shape to be installed longitudinally in the tubular implant device of the present invention and which may also be used in many other catheter probes, tubes or other related implantable applications. In preferred embodiment, it can also be built in small blocks of hybrid wafers where small wafer blocks and or chips are placed over flexible polyimide multi-layer circuit board to be rolled over the implant's internal tube for easy packaging thereby occupying limited space from the outer diameter and leaving maximum area for internal luminal pipe. The preferred embodiment of the present invention uses the most advanced and latest semiconductor process technology. Therefore it operates at a very low voltage thereby consumes extremely small power and dissipates negligible heat and is able to operate longer wjth small battery. The preferred embodiment of the present invention uses larger capacity memory area in all three types of memory (ROM, RAM, and Flash etc.) than any existing ultra-small scale implantable chips and controller. In other preferred embodiments, these memory blocks are divided in three groups where first group uses small capacity during least function operation and remaining memory blocks (second and third) remain disabled and are empowered only when they are required. The preferred embodiment of the present invention uses two methods of battery power: one with chargeable nano battery 730; and the other with nano bio-thermal battery power 748 which takes body heat to convert it into electricity and drives the implant for intended operation. However, additional larger implantable battery 731 can also be connected for user specific applications as described and presented in FIG. 19. In preferred embodiment of the present invention, the other most important semiconductor controller chip construction block is a multi-sensor chip in Single or multiple Ions-Selects, and Electro-physiology Membrane Potential, Capacitance and Conductance Measurements Controller in Potentiometric, Amperometric and or Conductometric measurement of fallopian tube fluids and its cell membrane wall and or vascular or intravascular fluids and its cell membrane specimens measurements. In preferred embodiment of the present invention, the tubular implant device's multi-sensors chip circuit controller can be built with various ions-select type controllers depending on its sensor type as described in FIG. 1 and onwards, in ultra small scale longitudinally to fit in tube or catheter like space. The preferred embodiment of the present invention in which all chips, controllers, and sensors are built "Novel" longitudinally round tubular or half-round tubular and or in flexible bend shape tubular form to fit in the catheter or tube and to leave maximum intra-lumen space for flowing path of the internal lumen and to be fixed or installed longitudinally over the outer wall of the inner lumen flow path as shown and presented in FIG. 8 at 425 and 426. Nevertheless, preferred embodiment of the present invention is in its control function actually opens, closes or regulates the lumen flow path using various types of micro miniature actuators and or motorized gate valve which not only operates on its own based on prediction mechanism as described in FIG. 15, 16, 17, and 18 respectively, but is also controlled wirelessly through program application decision or action or through user intervention wirelessly at any point.

Hie multi-sensor chip controller 735 is interfaced with electrodes and sensors for electrophysiology voltage, impedance (conductance) and capacitance measurements and with electrodes and sensors for ions-select multi-sensor chip (Chloride, Sodium, Potassium, Calcium, and pH, or combination of one or more such ions-selects) sensors or ion-selects and electrophysiology measurement controller in one chip. Controller 735 amplifies selected specimens from their corresponding electrodes or sensor groups 736 and 737 along with their reference electrodes 742 and 752. Amplified data is passed through signal condition controller 751 to remove noise from amplified signal sensed from its sensor electrodes. Temperature controller chip 733 and flow and pressure sensor controller 744 are also interconnected with signal condition controller 751. Flow, pressure and accelerometer controller 744 reads flow signals from flow sensor 746, pressure measurement from pressure sensor 745, and determines XYZ direction and acceleration (motions or movements) from its sensor 754 and amplifies them to be more readable where these sensor signals are treated at controller 751. The said controller's (751) multiplexer treat signal conditioner one-by-one orders not only to simplify circuit but also to take less chip area space and its analog signal is also converted into digital format with the same controller and it sends digital sensor data to micro controller for further processing or simply sends out wirelessly to smart remote control. In another preferred embodiment, electronic circuit blocks can be built with single or multiple System-on-Chips packaging methodology. First System-on-Chip can be built with combination of all sensor controllers 735, 733 and 744, signal condition controller 751, wireless controller 738 and time and date clock controller 747 in stand-alone function as well as integrated blocks with second System-on-Chip which includes micro controller 721, all three memory groups 725, 726 and 727 respectively, high voltage converter 724 and actuator or motor controller 723 and power supply controller 730. In preferred embodiment, blocks 660 and 662 can be built in one group with control functionality along with inductive power controller 730 and 732 for simple and straight function, whereas block 661 can be built as tiny ultra small scale footprint System-on-Chip and perform integrated and more sophisticated functions of 661 and operation of the present invention with least user intervention. with date and time stamp by its controller 747 and also saved in Flash and or RAM according to date and time stamp so that prediction and watch-dog algorithm could analyze data based on historical and current readings.

Tn preferred embodiment of the present invention sensor data can be sent out straight to smart remote control device with or without data saved in Flash memory, while in signal processing operation mode sensor data is processed by DSP and micro controller 721 and saved in the Flash memory and may also be analyzed and, after making it's finding, can control actuating valve accordingly as per its configuration saved in Flash memory and set by user.

As required in strict regulation, each implantable device is hardwired with its implantable ID (identification number) chip 729 which is used in all communications as a means of valid communication ID with external devices. The implant device is inducted with control switch 665. The type of control switch 665 can be of any kind which may include magnetic switch, or electromechanical switch, relay switch, reed-switch and or simply a mechanical push button switch, where control switch can be turned on or off for opening or closing actuator valve and or turning on or off the implant device and or such on and off works in a Morris-key code system for making several uncountable possibilities of control thereby.

In preferred embodiment of the present invention, when due time is up for taking measurement sample data from each sensor and electrode as per program, the power of supply controller, charger and power management controller 730 turns-on on all required system blocks chips which record the sensor value after signal conditioning and or with data 37

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remote control device communicates wirelessly with the tubular implant device, it will download all sensor measurement data for processing. This frees-up users not to bother by taking samples in precise time of the day every day or multiple times in just one day. And after taking sensor measurement, implantable chips go back in turn-off state except clock and power management controllers.

In preferred embodiment of the present invention, when smart remote control device's inductive power antenna's magnetic field crosses the implantable inductive coupling coil 732, it energizes the power to the implantable electronic chips blocks and first it shakes hand with chip ID security check and once it is recognized as a valid known device communication, it accepts commands from smart remote control device and acts and functions according to the instructions received. Analog and digital signal processor and micro controller 721 is a general purpose controller to perform all intended operations and functions as described in the entire document.

In preferred embodiment of the present invention, the implantable block diagram of chips together with its built-in software program performs all the functions and operations which have been described in this entire document from the beginning till the end. Additionally, it performs and executes even more functions and operations according to its building blocks and invention which are not mentioned here because it is not feasible to write each and every possible function and operation here, as it is not limited in its applications and operations in its widest possible scope. In preferred embodiment of the present invention, actuator or motor driver controller /ZJ can be designed according to the type of actuation or type of motor it uses. Tn addition to this, the driver controller low to high voltage booster controller 724 is used because entire semiconductor electronic chips are designed with low power nano scale semiconductor chip technology devices and, for this and other reasons, batteries used in the preferred design are also low-voltage. Therefore, if required by specific type of principle and types of material used in actuator or motor, can deliver higher potential voltages can be delivered for actuation and or motion. Left and right switches 734 and 728 are mechanical switches which are attached with mechanical assembly of actuator or motor for extreme position markers when actuator or motor cannot be energized in the same direction when it reaches maximum displacement, as shown and described in FIG. 9 of the present invention. Similarly, in the preferred embodiment of the present invention, actuator or motor is also mechanically fitted with variable resistance 750, giving it mechanical dispositions between both extremes from contact switches left and right, as shown and described in FIG. 9 as well.

Another preferred embodiment of the present invention is that the electronic circuit block may also have tissues, cells or nerves stimulating electrodes 667 and their stimulating controller 666 where it is necessary, the said implant device also sends stimulation pulses to its external encapsulation layer through electrodes. Electrodes can be placed in addition to the earlier sensing electrodes or they can be simply used in switching by means of multiplexing to use sensing electrodes as stimulating electrodes. This is enabled in preferred embodiment of the present invention wherein said tubular implant device stimulates external wall of the tube, duct, vascular or flowing path based on specific changes or to achieve specific results when meeting or exceeding measuring specimen(s) in one or more physiological, biochemical, electrophysiological, physical conditions or through software control locally within implant or through wirelessly.

Fig. 23 illustrates another application usage example in which the Tubular Implant Device is implanted in Male to achieve Male Contraception. In fig. 23, 1200 is an implant delivery device whose description has been described in detail in Fig.l and on wards. However, the implant delivery device 1200 is connected with implant delivery catheter 1202 whose size length and diameter is much smaller in order to lumen diameter and conduit paths from urethra, through ejaculatory duct, to vas deferens to epididymis. 1203 is glan tip of the penis where catheter 1202 is inserted through urethra 1206 and passing through ejaculatory duct within prostate 1212 to the ampula of vas deferens where tubular implant device 1209 is implanted as it is also shown in 1210. 1204 and 1205 are the larger view of tubular implant device implanted in the ampula of vas deferens. 1211 is a bladder whose neck is joined with prostate. 1201 is a smart PDA with cell phone as described earlier in Fig. 20. Function and operation in this application example is straight forward. A simple command from wireless device 1201 is transmitted wirelessly (remotely) to both implant devices 1209 and 1210. When selected for contraception mode, both implant devices completely block its lumen path where it is implanted thereby stopping sperms to pass through its lumen during ejaculation phase of sexual intercourse. Similarly, during normal course of the day, these implant devices remained open its lumen paths, like they don't exits in there. This is a non- contraceptive mode. This has been shown at 1215. The implant 1214 when in contraceptive mode the sperms are blocked as shown in 1213 and if it is set as non-contraceptive mode, the sperms 1216 are free to pass through the implant. FIG. 24 illustrates yet another application usage example in which the Tubular Implant Device is implanted in Male for the treatment, control and or managing Benign Prostatic Hyperplasia (BPH) and bladder outlet obstruction (BOO) conditions. 1251 is an implant deliver device as stated in Fig. 23 at 1200. The catheter 1252 is inserted at external urethral orifice 1253 towards lumen of prostate 1255. Depending on specific condition of each male, the tubular implant delivery catheter would install implant where the lumen path between bladder neck and urethral oriffice. In fig. 24, the implant device is implanted at bladder neck at 1257. Additional battery is connected with implant device 1258 whose battery is comfortably housed in bladder 1259. Implant device and battery is shown in large scale at 1261. The function and operation is also straight forward. The implant device 1258 as it is described in detail earlier is also imbued with pressure and flow sensors. The PDA or smart cell phone 1268 can communicate with implant device to give the internal filling of bladder. When necessary, simply open the implant device's lumen path, would let comfortably empty bladder and when it is empty, the lumen of implant device can be closed again. Two examples shown for clarity in which bladder 1265 has implant device and bladder 1262 is not. Implant device 1266 demonstrate full control of urinary flow where is bladder 1262 demonstrate leakage of urinary drops 1263 and 1264. The lumen path of the implanted device can be opened or closed in various ways as it is described earlier description of the present invention.

FIG. 25 illustrates demonstrate example of application usage in which the Tubular Implant Device is implanted in female for the treatment, control and or managing urinary incontinence. 1300 is an implant delivery device as stated in Fig. 23 at 1200. The catheter 1301 is inserted at external urethral orifice 1302 of the female 1305. The tubular implant device of the present invention 1303 is also attached with additional battery 1306 which is housed in the bladder 1304 comfortably. 1307 shows larger view of tubular implant device and battery. Two examples shown for further clarity in which bladder neck of 1313 is shown with implant device of the present invention whereas bladder 1308 is without implant. The implant 1312 fully assists to treat, control and or manage urinary incontinence without the need for medications and surgery. Wireless device 1314 also gives detail of bladder pressure and flow which not only simplify the operation but also sophisticate the control and manage the condition. The lumen path of the implanted device can be opened or closed in various ways as it is described earlier description of the present invention.

FIG. 26-A and FIG.26-B illustrate the "Novel" application example of the Novel tubular implant device of the present invention to treat, and mange erectile dysfunction. Fig, 26-A demonstrate implanting procedure of the implant devices in blood vessels. Implant delivery devices 1351, 1363, and 1370 are similar to what it is described in FIG. 23 except that these implant delivery devices are not equipped with hystrofiberscopes instead it is connected with OCT (Optical Coherence Tomography) probes where 1352, 1362, and 1369 are further connected with OCT image devices. The implant delivery device may also be connected with intravascular ultrasound probes to give image guidance in blood flow vessels or where visual image camera is unable to provide guided images. As shown in 1363, the implant delivery device's catheter 1354 is inserted through branula 1365. The catheter 1354 is exit from branula's distal needle 1366 where the distal end of the catheter is shown at 1367. The tubular implant device of the present invention is implanted in the male 1360's blood vessels as shown in 1360. The catheter 1353 of implant delivery device 1351 is inserted in the branula 1354 through femoral artery 1358. The catheter passes through abdominal aorta to the opposite side of the common iliac artery and from there it enters into internal pudendal artery and placed implants 1359 and 1357. 1357 is a deep dorsal vein of the penis. 1356 is a glans of penis. Implant devices 1359 and 1357 are installed in both left and right internal pudendal artery when it is activated, these tubular implant devices cause dilation of artery through initiating stimulating current to its outer electrodes causes endothelial wall to dilate (expand its lumen path) to increase arterial blood flow to the penis.

Implant delivery device 1370 is also passes through branula 1370 to the deep dorsal vein of the penis 1380 and implanted tubular implant 1381 of the present invention of the male 1368. When activated, the novel tubular implant device not only narrowed its lumen path to blocked the veinus blood out from the deep dorsal vein but also send stimulating charge to its outer electrodes to cause endothelial of wall of the vein to constrict its lumen path. Combinations of hese implants (1359, 1357 and 1381) in such scheme resultantly increase arterial blood flow and then to trap arterial blood flow out from the deep dorsal vein to cause erection whenever it is needed and for how long it is required without any medication. Similarly, during normal course of the day, these implants remain inactive and keeping its lumen open and free so as they do not present in the vessels.

FIG 26-B illustrates the application example of novel tubular implant in treating and managing erectile dysfunction in relation to fig. 26-A. 1418 is a male in which implant devices are inactive. The penis 1417 is showing in flaccid shape. The blood vessel 1415 is neither dilating nor constricting thereby no changes in blood flow as shown in 1416. The male 1400 is shown in rigid erection mode in which wireless PDA, or smart phone 1424 sending activating command wirelessly to cause erection as explained in fig. 26-A. Artery 1414 is dilating 1413 increasing arterial blood flow 1412. Vein 1427 is constricting 1426 decreasing arterial blood flow 1425. FIG. 27 illustrates yet another application example of the tubular implant device of the present invention to provide "Novel" Implant-Assisted-Fertilization method and process. Implant-Assisted-Fertilization (IAF) is a state-of-the-art fertilization technique, which assist natural fertilization for couple whose infertility factors are because of tubal mechanical (fallopian tubes) and ovulatory and pregnancy related hormones. IAF assist in creating favorable environment so that both egg and sperms could fertilized naturally. IAF is not just limited to fertilization of oocyte as oppose to IVF but it is a closed-loop procedure which monitors pregnancy and assist in treating pregnancy related complications before it could end up in miscarriage or abortion. Implant-Assisted-Fertilization procedure does not cover neurological and physical abnormality of organs. However, it fully cover mechanical path of fallopian tube in cases where tubes are blocked, narrowed, scared, liagated and broken or burst. IAF is free from all problems of IVF.

1450 is a startup of Implant-assisted fertilization process. 1451 is a phase-1 of the implant assisted fertilization phase which is also called an Evaluation and Preparation Phase: This involves couple's medical evaluation if qualify for IAF. Qualified Patient gets induction of IAF Implants. IAF Patient get continuous recording of Menstruation Cycles for ovulation and hormonal patterns. 1452 is a phase-2 of the implant assisted fertilization which is also called Pre-Fertilization Phase. Based on historical data in Phase-1, customized strategy for IAF is developed. To begin with IAF, Micro-manipulation of reproductive hormones using medications is conducted till the successful peak of ovulation where couple is proceeded for natural intercourse. If required, sperms can be injected in the fallopian tubes. Sperms that are injected are collected during natural intercourse ONLY. 1453 is a phase-3 of the implant-assisted fertilization and is called Post Fertilization Phase. On successful IAF fertilization, TAF Patient is continuously monitored pregnancy related hormones. If required, micro-manipulation of pregnancy hormones is conducted using medications to maintain pregnancy. IAF monitors for early Ectopic pregnancy till Morula or Blastocyst is passed to Uterus.

1454 is the phase-4 of the implant-assisted fertilization method and it is called Pregnancy Follow-up Phase. On successful Blastocyst in uterus, IAF Patient is continuously monitored for pregnancy related hormones and early signs of miscarriages. If required, Micro - manipulation of pregnancy related hormones, symptoms and conditions are regulated and corrected using medications to keep the pregnancy on its growth pattern. Follow-up Phase-4 till the delivery of birth or termination of pregnancy.

1457 and 1460 are two right and left fallopian tubes of the female which are having implanted with the Novel tubular implant devices of the present invention where PDA or smart phone device 1456 works in conjunction with various prediction mechanisms and flow charts as shown and discussed in the present invention to achieve implant-assisted fertilization.

Various descriptions of the present invention have been described above and it should be understood that the various features can be used singularly or in any combination thereof, therefore, this invention is not limited to only the specifically preferred embodiments depicted herein. The Novel tubular implant device also provides an alternative and or substitute lumen path of tubes, ducts, vessels, urethras, ureters and or any conduits etc. for blocked, cut, injured, scarred, plaqued, enlarged and or narrowed tubes, ducts, vessels, urethras, ureters or any conduits etc. of male and or female for opening or grafting of various vessels, ducts, tubes, urethras, ureters and or any fluid circulation paths including controlling and regulating their flow paths based on various measuring parameters thereof.

The present invention assists in treating and solving male and or female's contraception, sterilization, vasectomy, infertility, pregnancy, ectopic pregnancy, abortion, miscarriage, ovulation,pre and post ovulation hormonal prediction , measurement problems and fertilization monitoring. Similarly, in situations where lumen path of male and or female

[such as tubes, ducts, vessels , urethras, ureters and or conduits and flowing paths etc.] is blocked, cut, injured, scarred, plaqued, enlarged and or narrowed, the present invention also assists in reversing these conditions.

The Novel tubular implant device may also be used directly or indirectly for treating, managing and controlling incontinence , benign prostatic hyperplasia (BPKf), bladder outlet obstruction (BOO), erectile dysfunction (ED), vital systemic circulatory routes, fetal circulation, , vessels, etc. are just a few to mention.

It is however further pointed out that, while a certain illustrative method and apparatus embodying the present invention has been shown in the drawings and described above in considerable detail, it should be understood however that there is no intention to limit the invention to the specific forms and embodiments disclosed. On the contrary, the intention is to cover all modifications, alternative constructions, equivalents, methods and uses falling within the spirit and scope of the invention as expressed in the claims, back ground, objectives, drawings and descriptions.

Claims

Claims r patenting the present invention, we claim:

1. An implant device for placement in a male and or female vessel, tube or duct to

regulate fluid flow through the vessel, tube or duct, the implant device comprising:

an elongate tubular housing dimensioned for placement coaxially within the

lumen of the vessel, tube or duct;

a tubular conduit mounted within the housing, each end of which is sealed to

a respective end of the housing to define a fluid passageway through the housing

that is in fluid communication with the lumen of the vessel, tube or duct, and to

define a hermetically or otherwise sealed circumferential space between the conduit

and the housing;

a valve mounted inline with the conduit and being operable for regulating the

fluid flow through the passageway;

a source of mechanical energy mounted within the circumferential space and

coupled to the valve for moving the valve in response to a control signal from

controller; where source of mechanical energy means an actuator and or a motor,

and controller means for providing a control signal to the source of mechanical

energy in response to a stimulus that originates externally of the implant device.

2. The device as claimed in claim 1, further including a first source of electrical energy

located within the circumferential space and being connected to the source of

mechanical energy, and wherein the source of mechanical energy is an actuator or

motor for converting electrical energy from the first source of electrical energy into

mechanical energy to drive the valve.

3. The device as claimed in claim 2, wherein the first source of electrical energy

comprises an inductive coil that translates an external electromagnetic energy into

electrical energy for the actuator or motor.

4. The device as claimed in claim 2, wherein the first source of electrical energy

comprises a nano-battery.

5. The device as claimed in claim 1, wherein the first source of electrical energy

comprises a nano biothermal battery.

6. The device as claimed in any one of claims 3 to 5, further including a transceiver

antenna for receiving and transmitting wireless data signals, and wherein the

controller means comprises a control circuit connected to the antenna for receiving the data of the wireless signal and translating the data into a control signal to the

actuator or motor for controlling the action of the actuator or motor to drive the

valve.

7. The device as claimed in claim 6, wherein the actuator or motor is a tubular actuator

or motor.

8. The device as claimed in any one of claims 6 and 7, wherein the control circuit is a

flexible longitudinal electronic control circuit that is bendable to conform to the

available space in the circumferential space in the housing.

9. The device as claimed in any one of claims 7 and 8, further including one or more

sensors connected to the electronic control circuit for sensing environmental

information within the vessel, tube or duct, and wherein the electronic control circuit

includes preprogrammed instructions to measure and evaluate the environmental

information and send a control signal to the actuator or motor based on the

evaluation of the environmental information and or to transmit out.

10. The device as claimed in claim 9, wherein the sensors comprise, in various

combinations, one or more sensors electrodes from the group consisting of

biochemical sensors, electrophysiological sensors, physical sensors, Electrodes and

physiological sensors.

11. The device as claimed in claim 10, wherein at least one of said sensors is mounted

on the conduit within the fluid passageway.

12. The device as claimed in claim 11, wherein the sensors on the conduit are recessed

into the conduit wall so as to not obstruct any of the fluid passageway.

13. The device as claimed in claim 9, wherein at least one of said sensor electrode is

mounted on an outer surface of the housing which, in situ, contacts a portion of the

wall of the vessel, tube or duct within which the device is implanted.

14. The device as claimed in claim 13, wherein the sensors on the surface of the housing

are recessed into the wall of the housing so as not to interfere with the wall of the

vessel, tube or duct within which the device is implanted.

15. A self-controlled implant device for placement in a mammalian vessel, tube or duct

to regulate fluid flow through the vessel, tube or duct, the implant device

comprising:

an elongate tubular housing dimensioned for placement coaxially within the

lumen of the vessel, tube or duct;

a tubular conduit mounted within the housing, each end of which is sealed to

a respective end of the housing to define a fluid passageway through the housing that is in fluid communication with the lumen of the vessel, tube or duct, and to

and the housing;

a valve mounted inline with the conduit and being operable for regulating the

fluid flow through the passageway;

an actuator or motor mounted within the circumferential space for providing

mechanical energy to operate the said valve in response to a control signal;

one or more sensors on the housing or on the conduit for sensing

environmental information within the vessel, tube or duct;

a electronic control circuit within the circumferential space connected to the

sensors for receiving the environmental information, wherein the electronic control

circuit includes preprogrammed instructions to evaluate the environmental

information and send a control signal to the actuator or motor based on the

evaluation of the environmental information; and

a nano-battery mounted within the circumferential space for providing

electrical energy to the electronic control circuit and actuator or motor.

16. The device as claimed in claim 15, wherein the control circuit is a flexible

longitudinal electronic control circuit that is bendable to conform to the available

space in the circumferential space in the housing.

17- The device as claimed in claim 16, wherein the actuator or motor comprises a

tubular actuator or motor.

18. The device as claimed in claim 17, wherein the valve comprises a tubular diagonal

bendable knife gate valve.

19. The device as claimed in claim 17, wherein the valve comprises a tubular U-channei

bendable knife gate valve.

20. The device as claimed in claim 17, wherein the valve comprises a tubular double-

symmetrical pinching gate valve.

21. The device as claimed in claim 17, wherein the valve comprises a tubular balloon

gate valve.

22. The device as claimed in any one of claims 18 - 21, wherein the sensors comprise,

in various combinations, one or more sensors from the group consisting of

biochemical sensors, electrophysiological sensors, physical sensors and

physiological sensors.

23. An electromagnetically controlled implant device for placement in a mammalian

vessel, tube or duct to regulate fluid flow through the vessel, tube or duct, the

implant device comprising:

an elongate tubular housing dimensioned for placement coaxially within the

lumen of the vessel, tube or duct;

a tubular conduit mounted within the housing, each end of which is sealed to

and the housing;

a valve mounted inline with the conduit and being operable for regulating the

fluid flow through the passageway;

an electronic actuator or motor mounted within the circumferential space for

providing mechanical energy to operate the valve in response to a control signal;

an inductive coil that translates an external electromagnetic energy into

electrical energy for the actuator or motor; and controller means for providing a control signal to the actuator or motor in

response to a stimulus that originates externally of the implant device.

24. The device as claimed in claim 23, further including a transceiver antenna for

receiving and transmitting wireless data signals, and wherein the controller means

comprises a control circuit connected to the antenna for receiving the data of the

wireless signal and translating the data into a control signal to the actuator or motor

for controlling the action of the actuator or motor.

25. The deviee as claimed in claim 24, wherein the actuator or motor comprises a

tubular actuator or motor.

26. The device as claimed in claim 25, wherein the electronic control circuit is a flexible

space in the circumferential space in the housing.

27. The device as claimed in claim 26, wherein the valve comprises a tubular diagonal

bendable knife gate valve.

28. The device as claimed in claim 26, wherein the valve comprises a tubular U-channel

bendable knife gate valve.

29. The device as claimed in claim 26, wherein the valve comprises a tubular double-

symmetrical pinching gate valve.

30. The device as claimed in claim 26, wherein the valve comprises a tubular balloon

gate valve.

31. The device as claimed in any one of claims 27 - 30, further including one or more

sensors connected to the electronic control circuit for sensing environmental

information vessel, tube or duct and transmitting the environmental information to

the electronic control circuit, and wherein the electronic control circuit includes

preprogrammed instructions to evaluate the environmental information and send a

control signal to the actuator or motor based on the evaluation of the environmental

information.

32. The device as claimed in claim 31, wherein the sensors comprise, in various

combinations, one or more sensors from the group consisting of biochemical sensors,

electrophysiological sensors, physical sensors and physiological sensors.

33. The device as claimed in claim 32, wherein at least one of said sensors is mounted

on the conduit within the fluid passageway.

34. The device as claimed in claim 33, wherein the sensors on the conduit are recessed

into the conduit wall so as to not obstruct any of the fluid passageway.

35. The device as claimed in claim 32, wherein at least one of said sensors is mounted

on a surface of the housing which, in situ, contacts a portion of the wall of the vessel,

tube or duct within which the device is implanted.

36. The device as claimed in claim 35, wherein the sensors on the surface of the housing

vessel, tube or duct within which the device is implanted.

37. A contraceptive implant for placement in the fallopian tubes of a mammal, the

implant comprising:

an elongate tubular housing dimensioned for placement coaxially within the

lumen of the fallopian tube;

a tubular conduit mounted within the housing, each end of which is sealed to

that is in fluid communication with the lumen of the fallopian tube, and to define a

hermetically or otherwise sealed circumferential space between the conduit and the

housing; a valve mounted inline with the conduit and being operable for regulating the

fluid flow through the passageway;

a source of mechanical energy mounted within the circumferential space and

coupled to the valve for moving the valve in response to a control signal; and

controller means for providing a control signal to the source of mechanical

38. The device as claimed in claim 37, further including a first source of electrical

energy located within the circumferential space and being connected to the source of

mechanical energy, and wherein the source of mechanical energy is an electronic

actuator or motor for converting electrical energy from the first source of electrical

energy into mechanical energy to drive the valve.

39. The device as claimed in claim 38, wherein the first source of electrical energy

comprises and inductive coil that translates an external wireless signal into electrical

energy for the actuator.

40. The device as claimed in claim 38, wherein the first source of electrical energy

comprises a nano-battery.

41. The device as claimed in claim 38, wherein the first source of electrical energy

comprises a nano biothermal battery.

42. The device as claimed in any one of claims 39 to 41, further including a transceiver

antenna for receiving and transmitting wireless data signals, and wherein the

controller means comprises a control circuit connected to the antenna for receiving

the data of the wireless signal and translating the data into a control signal to the

actuator or motor for controlling the action of the actuator or motor.

43. The device as claimed in claim 42, wherein the actuator or motor comprises a

tubular actuator or motor.

44. The device as claimed in any one of claims 42 and 43, wherein the control circuit is

a flexible longitudinal electronic control circuit that is bendable to conform to the

available space in the circumferential space in the housing.

45. The device as claimed in any one of claims 43 and 44, further including one or more

sensors connected to the electronic control circuit for sensing environmental

information within the fallopian tube and wherein the electronic control circuit

includes preprogrammed instructions to evaluate the environmental information and

send a control signal to the actuator or motor based on the measurement and

evaluation of the environmental information.

46. The device as claimed in claim 45, wherein the sensors comprise, in various

electrophysiological sensors, physical sensors and physiological sensors.

47. The device as claimed in claim 46, wherein at least one of said sensors is mounted

on the conduit within the fluid passageway.

48. The device as claimed in claim 47, wherein the sensors on the conduit are recessed

into the conduit wall so as to not obstruct any of the fluid passageway.

49. The device as claimed in claim 46, wherein at least one of said sensors is mounted

on a surface of the housing which, in situ, contacts a portion of the wall of the

fallopian tube within which the device is implanted.

50. The device as claimed in claim 49, wherein the sensors on the surface of the housing

vessel, tube or duct within which the device is implanted.

51. A implant for placement in the urethra of a male and or female to control the flow of

urine out of the bladder, the implant comprising:

an elongate tubular housing dimensioned for placement coaxially within the

lumen of the urethra; a tubular conduit mounted within the housing, each end of which is sealed to

that is in fluid communication with the lumen of the urethra, and to define a

housing;

a valve mounted inline with the conduit and being operable for regulating the

urine flow through the passageway;

a source of mechanical energy mounted within the circumferential space and

coupled to the valve for moving the valve in response to a control signal; and

controller means for providing a control signal to the source of mechanical

52. The device as claimed in claim 51, further including a first source of electrical

mechanical energy, and wherein the source of mechanical energy is an electronic

energy into mechanical energy to drive the valve.

53. The device as claimed in claim 52, wherein the first source of electrical energy

energy for the actuator or motor.

54 The device as claimed in claim 52, wherein the first source of electrical energy

comprises a nano-battery.

55. The device as claimed in claim 52, wherein the first source of electrical energy

comprises a nano biothermal battery.

56. The device as claimed in any one of claims 53 to 55, further including a transceiver

antenna for receiving and transmitting wireless data signals, and wherein the

actuator or motor for controlling the action of the actuator or motor.

57. The device as claimed in claim 56, wherein the actuator or motor comprises a

tubular actuator or motor.

58. The device as claimed in any one of claims 56 and 57, wherein the control circuit is

available space in the circumferential space in the housing.

59. The device as claimed in any one of claims 57 and 58, further including one or more

pressure sensors connected to the electronic control circuit for sensing the pressure

of the urine in the bladder and transmitting the pressure information to the electronic

control circuit, and wherein the electronic control circuit includes preprogrammed

instructions to evaluate the pressure information and send a control signal to the

actuator based on the evaluation of the pressure information.

60. The device as claimed in claim 59, further including one or more flow sensors

connected to the electronic control circuit for sensing the flow of urine in the urethra

and transmitting the flow information to the electronic control circuit, and wherein

the electronic control circuit includes preprogrammed instructions to evaluate the

flow information and send a control signal to the actuator based on the evaluation of

the flow information.

61. The device as claimed in claim 60, further including one or more pH sensors

connected to the electronic control circuit for sensing the pH of urine in the urethra

and transmitting the pH information to the electronic control circuit, and wherein the

electronic control circuit includes preprogrammed instructions to evaluate the pH

information and send a control signal to the actuator based on the evaluation of the

pH information.

62. A remote controlled contraceptive implant for placement anywhere between tail of

epididymis and ductus deferens of a male mammal to control the flow of

spermatozoa out of Hie testes, the implant comprising:

an elongate tubular housing dimensioned for placement coaxially within the

lumen of the tail of epididymis and ductus deferens;

a tubular conduit mounted within the housing, each end of which is sealed to

that is in fluid communication with the lumen of the urethra, and to define a

housing;

a valve mounted inline with the conduit and being operable for regulating the

sperm flow through the passageway;

a source of mechanical energy mounted within the circumferential space and

coupled to the valve for moving the valve in response to a control signal; and

controller means for providing a control signal to the source of mechanical

63. The device as claimed in claim 62, further including a first source of electrical

mechanical energy, and wherein the source of mechanical energy is an electronic

energy into mechanical energy to drive the valve.

64. The device as claimed in claim 63, wherein the first source of electrical energy

energy for the actuator or motor.

65. The device as claimed in claim 63, wherein the first source of electrical energy

comprises a nano-battery.

66. The device as claimed in claim 63, wherein the first source of electrical energy

comprises a nano biothermal battery.

67. The device as claimed in any one of claims 63 to 66, further including a transceiver

antenna for receiving and transmitting wireless data signals, and wherein the

actuator or motor for controlling the action of the actuator or motor.

68. The device as claimed in claim 67, wherein the actuator or motor comprises a

tubular actuator or motor.

69. The device as claimed in any one of claims 67 and 68, wherein the control circuit is

available space in the circumferential space in the housing.

70. A valve for use in an implant device for placement in a mammalian vessel, tube or

duct to regulate fluid flow therethrough, the valve comprising:

a first tubular conduit having a first end;

a second tubular conduit axially aligned with the first tubular conduit and

having a second end located near the first end;

a housing between the conduits and sealed to the first and second ends, and

defining an internal chamber that is in fluid communication with the first and second

conduits such that the conduits and the chamber define a fluid flow path, and

wherein the internal chamber defines a pathway that intersects the fluid flow path;

an elongate planar bendable blade movably mounted within the pathway and

being slidable between a closed position in which the blade interferes with the fluid flow path, and an open position in which the blade does not interfere with the fluid

flow path; and

an actuator or motor connected to the blade to move the blade between the

open and closed positions in response to a control signal.

71. The device as claimed in claim 70 wherein a portion of the pathway diagonally

intersects the fluid flow path.

72. The device as claimed in claim 71 wherein the chamber in the housing comprises a

first planar portion that diagonally intersects the conduit, and a second planar

portion that is generally parallel with the conduit, wherein the blade in the closed

position is located within the first and second planar portions, and in the open

position is located within the second planar portion, and wherein the blade is capable

of bending as it is moved through the first and second planar portions.

73. The device as claimed in claim 72, wherein a portion of the pathway perpendicularly

intersects the fluid flow path.

74. The device as claimed in claim 73 wherein the chamber in the housing comprises:

a first planar portion that is generally parallel to the conduit; a second planar portion that is perpendicular to the first planar portion and

which perpendicularly intersects the conduit; and

a third planar portion that is perpendicular to the second planar portion and is

generally parallel with the conduit, wherein the blade in the open position is located

within the first planar portion, and in the closed position is located within the first,

second and third planar portions, and wherein the blade is capable of bending as it is

moved through the first, second and third planar portions.

75. The device as claimed in any one of claims 70 - 74, wherein the actuator or motor is

a tubular actuator or motor mounted around the second conduit.

76. The device as claimed in claim 75, wherein the actuator comprises:

a stationary inner tubular stator mounted around the second conduit; and

an outer tubular actuating electrode movably mounted around the inner

tubular stator and being connected to the blade, wherein the outer tubular actuating

electrode moves in relation to the tubular stator in response to electrical energy

provided to the actuator. J.3 J.

77. The device as claimed in claim 76, wherein the inner tubular stator and outer tubular

actuating electrode are comprised of piezoelectric material that responds to the

charge of the electrical energy being provided to cause the outer tubular actuating

electrode to selectively move in direction (left or right depending on the polarity of

said electrical energy) along the inner tubular stator.

78. The device as claimed in claim 77, further including a plurality of contact switches

positioned longitudinally between the inner tubular stator and the outer tubular

actuating electrode for controlling the distance of motion of the outer tubular

actuating electrode in relation to the inner tubular stator.

79. A valve for use in an implant device for placement in a mammalian vessel, tube or

duetto regulate fluid flow therethrough, the valve comprising:

a first tubular conduit, defining a fluid flow path, and having a deformable

flexible tubular portion;

a plurality of pinching arms connected to the conduit and positioned adjacent

the flexible tubular portion, the arms being movable between a closed position in

which the arms pinch the flexible tubular portion to interfere with the fluid flow path,

and an open position in which the arms do not pinch the flexible tubular portion to

allow unimpeded fluid flow; and an actuator connected to the arms to move the arms between the open and

closed positions in response to a control signal.

80. A valve for use in an implant device for placement in a mammalian vessel, tube or

duct to regulate fluid flow therethrough, the valve comprising:

a first tubular conduit defining a fluid flow path;

a balloon connected to the conduit and being in physical communication

with the fluid flow path, wherein the balloon in its deflated state does not interfere

with the fluid flow path, and wherein the balloon is inflatable such that it is capable

of blocking the fluid flow path in its inflated state;

an inflation fluid conduit connected to the balloon for supplying an inflation

fluid for inflating the balloon;

a compressible and expandable inflation fluid reservoir connected to the

inflation fluid conduit for storing the inflation fluid;

an actuator connected to the inflation fluid reservoir for selectively

compressing or expanding the inflation fluid reservoir in response to a control signal,

thereby selectively inflating or deflating the balloon to regulate the fluid flow

through the conduit.

81. The device as claimed in any one of claims 80, wherein the actuator is a tubular

actuator mounted around the conduit adjacent the inflation fluid reservoir.

82. The device as claimed in claim 81, wherein the actuator comprises:

a stationary inner tubular stator mounted around the conduit; and

an outer tubular actuating electrode movably mounted around the inner

tubular stator and being connected to the inflation fluid reservoir, wherein the outer

tubular actuating electrode moves in relation to the tubular stator in response to

electrical energy provided to the actuator to selectively compress or expand the

inflation fluid reservoir.

83. The device as claimed in claim 82, wherein the inner tubular stator and outer tubular

actuating electrodes are comprised of piezoelectric material that responds to the

electrode to selectively move in one direction along the inner tubular stator.

84. The device as claimed in claim 83, further including a plurality of contact switches

positioned longitudinally between the inner tubular stator and the outer tubular actuating electrode for controlling the distance of motion of the outer tubular

actuating electrode in relation to the inner tubular stator.

85. A method of predicting pre-ovulation in a female human subject, which subject has experienced the onset of menstruation in her menstrual cycle, the method comprising the steps of: a) sensing invasively one or more of the properties selected from the group consisting of: i) concentration of estradiol or Estrogen in the fluid; ii) concentration of sodium (Na⁺) and chloride (Cl^") ions in the fluid; iii) concentration of calcium (Ca²⁺) and potassium (K⁺) ions in the fluid; iv) pH in the fluid; v) membrane potential in the cells or tissues; vi) conductivity in the cells or tissues; and vii) capacitance in the cells or tissues of a Fallopian tube of the female subject at least on a daily basis; b) generating output signals indicative of the levels of the properties sensed in step (a); and c) monitoring the output signals from the onset of menstruation to identify: i) in the case of concentration of estradiol or estrogen, a steady increase in concentration of estradiol or estrogen; ii) in the case of concentration of sodium (Na⁺) and chloride (Cl^") ions, a steady increase in concentration of sodium (Na⁺) and chloride (Cl^") ions; iii) in the case of concentration of calcium (Ca^-+) and potassium (K⁺) ions, a slight rise in concentration of calcium (Ca²⁺) and potassium (K⁺) ions; T/CA2006/000737

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iv) in the case of pH, a steady decrease in pH; v) in the case of membrane potential, an increase in membrane potential; vi) in the case of conductivity, an increase in conductivity; and vii) in the case of capacitance, an increase in capacitance; wherein the properties identified, either alone or in combination, indicate that the female human is approaching the ovulation phase of a menstrual cycle.

86. The method as in claim 85, further comprising the step of comparing the levels indicated in step (b) with mean values of corresponding properties obtained in at least one previous menstrual cycle of the female human in identifying the changes listed in (c).

87. The method as in claim 86 wherein the levels indicated in step (c) occur after the tenth day from menstruation.

88. A method of predicting ovulation in a female human subject, which subject has experienced the onset of menstruation in her menstrual cycle, the method comprising the steps of: a. sensing invasively one or more of the properties selected from the group consisting of: i. temperature; ii. concentration of estradiol or estrogen in the fluid; iii. concentration of luteinizing hormone in the fluid; iv. concentration of sodium (Na⁺) and chloride (Cl^") ions in the fluid; v. concentration of calcium (Ca²⁺) and potassium (K⁺) ions in the fluid; vi. pH in the fluid; vii. membrane potential in the cells or tissues; viii. conductivity in the cells or tissues; and ix. capacitance in the cells or tissues of a Fallopian tube of the female subject at least on a daily basis; b. generating output signals indicative of the levels of the properties sensed in step (a); and c. monitoring the output signals to identify: i. in the case of temperature, a rise in temperature from the levels at pre-ovulation ii. in the case of concentration of estradiol or estrogen, a steady decrease in concentration of estradiol or estrogen; iii. in the case of concentration of luteinizing hormone, a peak in concentration of luteinizing hormone; iv. in the case of concentration of sodium (Na⁺) and chloride (CY) ions, a sharp decline in concentration of sodium (Na⁺) and chloride (Cl^') ions from the levels at pre-ovulation; v. in the case of concentration of calcium (Ca²⁺) and potassium (K⁺) ions, an increase in concentration of calcium (Ca *) and potassium (K⁺) ions from the levels at pre-ovulation; vi. in the case of pH, a significant rise in pH from the levels at pre- ovulation; vii. in the case of membrane potential, a sharp rise in membrane potential from the levels at pre-ovulation; viii. in the case of conductivity, a sharp rise in conductivity from the levels at pre-ovulation; and ix. in the case of capacitance, a sharp rise in capacitance from the levels at pre-ovulation; wherein the properties identified, either alone or in combination, indicate that the female human is in the ovulation phase of a menstrual cycle.

89. The method as in claim 88, further comprising the step of comparing the levels indicated in step (b) with mean values of corresponding properties obtained in at least one previous menstrual cycle of the female human in identifying the changes listed in (c).

90. A method of predicting if no fertilization of an egg occurred post-ovulation in a female human subject, which subject has experienced the onset of menstruation in her menstrual cycle, the method comprising the steps of: a. sensing invasively one or more of the properties selected from the group consisting of: i. temperature; ii. concentration of progesterone in the fluid; iii. concentration of calcium (Ca²⁺) and potassium (K⁺) ions in the fluid; iv. pH in the fluid; v. membrane potential in the cells or tissues; vi. conductivity in the cells or tissues; and vii. capacitance in the cells or tissues of a Fallopian tube of the female subject at least on a daily basis; b. generating output signals indicative of the levels of the properties sensed in step (a); c. determining the levels of the properties sensed in step (a) at ovulation; and d. monitoring the output signals after ovulation to identify: i. in the case of temperature, a decline in temperature from the levels at ovulation; ii. in the case of concentration of progesterone, an increase., then a peak, followed by a steady decline in concentration of progesterone from the levels at ovulation; iii. in the case of concentration of calcium (Ca²⁺) and potassium (K⁺) ions, a decline in concentration of calcium (Ca²⁺) and potassium (K⁺) ions from the levels at ovulation; iv. in the case of pH, a decline in pH from the levels at ovulation; v. in the case of membrane potential, a decline in membrane potential from the levels at ovulation; vi. in the case of conductivity, a decline in conductivity from the levels at ovulation; and vii. in the case of capacitance, a decline in capacitance from the levels at ovulation; wherein the properties identified, either alone or in combination, indicate that fertilization has not occurred in the female human.

91. The method as in claim 90, further comprising the step of comparing the levels indicated in step (b) with mean values of corresponding properties obtained in at least one previous menstrual cycle of the female human in identifying the changes listed in (c).

92. A method of predicting if fertilization of an egg occurred after ovulation in a female human subject, which subject has experienced the onset of menstruation in her menstrual cycle, the method comprising the steps of: a. sensing invasively one or more of the properties selected from the group consisting of: i. temperature; ii. concentration of progesterone in the fluid; iii, concentration of calcium (Ca²⁺) and potassium (K⁺) ions in the fluid; iv. pH in the fluid; v. conductivity in the cells or tissues; and vi. capacitance in the cells or tissues of a Fallopian tube of the female subject at least on a daily basis; b. generating output signals indicative of the levels of the properties sensed in step (a); c. determining the levels of the properties sensed in step (a) at ovulation; and d. monitoring the output signals after ovulation to identify: L in the case of temperature, an increase in temperature from the levels at ovulation; ii. in the case of concentration of progesterone, a steady increase in concentration of progesterone from the levels at ovulation; iii. in the case of concentration of calcium (Ca²⁺) and potassium (K⁺) ions, an increase in concentration of calcium (Ca²⁺) and potassium (K⁺) ions from the levels at ovulation; iv. in the case of pH, an increase in pH from the levels at ovulation; v. in the case of conductivity, an increase in conductivity; and vi. in the case of capacitance, an increase in capacitance from the levels at ovulation; wherein the properties identified, either alone or in combination, are indicative that fertilization has occurred in the female human,

93. The method as in claim 92, further comprising the step of determining the presence of sperm in the Fallopian tube wherein the presence of sperm in conjunction with the levels identified in (d) supports the indication that fertilization has occurred, and the absence of sperm indicates that no fertilization has occurred.

94. A method of predicting if a normal pregnancy is taking place after fertilization of an egg in a female human subject, the method comprising the steps of: a. sensing invasively one or more of the properties selected from the group consisting of: i. temperature; ii. concentration of progesterone in the fluid; iii. concentration of calcium (Ca²⁺) and potassium (K⁺) ions in the fluid; iv. pH in the fluid; v. conductivity in the cells or tissues; and vi. capacitance in the cells or tissues of a Fallopian tube of the female subject at least on a daily basis; b. generating output signals indicative of the levels of the properties sensed in step (a); c. determining the levels of the properties sensed in step (a) at fertilization; and d. monitoring the output signals after fertilization to identify: i. in the case of temperature, a stabilization in temperature near the levels at fertilization; ii. in the case of concentration of progesterone, a steady increase in concentration of progesterone from the levels at fertilization; Hi. in the case of concentration of calcium (Ca²⁺) and potassium (K⁺) ions, a stabilization in concentration of calcium (Ca *) and potassium (K⁺) ions near the levels at fertilization; iv. in the case of pH, a stabilization in pH near the levels at fertilization; v. in the case of conductivity, a stabilization in conductivity near the levels at fertilization; and vi. in the case of capacitance, a stabilization in capacitance near the levels at fertilization; wherein the properties identified, either alone or in combination, indicate mat a normal pregnancy is taking place in the female human.

95. A method of predicting if an abnormal pregnancy is taking place after fertilization of an egg in a female human subject, the method comprising the steps of: a. sensing one or more of the properties selected from the group consisting of: i. temperature; iϊ. concentration of progesterone in the fluid; iii, concentration of sodium (Na⁺) and chloride (Cl^") ions in the fluid; iv. concentration of calcium (Ca²⁺) and potassium (K⁺) ions in the fluid; v. membrane potential in the cells or tissues; vi. conductivity in the cells or tissues; and vii. capacitance in the cells or tissues of a Fallopian tube of the female subject at least on a daily basis; b. generating output signals indicative of the levels of the properties sensed in step (a); c. determining the levels of the properties sensed in step (a) at fertilization; and d. monitoring the output signals after fertilization to identify: i. in the case of temperature, a fluctuation in temperature from the levels at fertilization; ii. in the case of concentration of progesterone, a fluctuation in concentration of progesterone from the levels at fertilization; iii. in the case of concentration of sodium (Na⁺) and chloride (Cl^") ions, a fluctuation in concentration of sodium (Na⁺) and chloride (Cl^") ions from the levels at fertilization; iv. in the case of concentration of calcium (Ca²⁺) and potassium (K⁺) ions, a fluctuation in concentration of potassium (K⁺) ions and calcium (Ca²⁺) ions from the levels at fertilization; v. in the case of membrane potential, a fluctuation in membrane potential from the levels at fertilization; vi. in the case of conductivity, a fluctuation in conductivity from the levels at fertilization; and vii. in the case of capacitance, a fluctuation in capacitance from the levels at fertilization; wherein the properties identified, either alone or in combination, indicate that an abnormal pregnancy is possibly taking place in the female human.

96. The method as claimed in any one of claims 85 - 95 wherein the step of sensing is carried out by one or more sensors and electrodes on a device that is implanted in a Fallopian tube of the female human subject.

97. The method as claimed in claim 96 wherein said device comprises a device as claimed in any one of the preceding claims.

98. A method of predicting pre-ovulation in a female human subject, which subject has experienced the onset of menstruation in her menstrual cycle, the method comprising the steps of: d) sensing invasively one or more of the properties selected from the group consisting of: i) concentration of estradiol or estrogen in the fluid; ii) concentration of SOdIUm (Na⁺) and chloride (Cl^") ions in a fluid; iii) concentration of calcium (Ca²⁴) and potassium (K⁺) ions in the fluid; iv) pH in the fluid; v) membrane potential in the cells or tissues; vi) conductivity in the cells or tissues; and vii) capacitance in the cells or tissues of a reproductive organ of the female subject at least on a daily basis; e) generating output signals indicative of the levels of the properties sensed in step (a); and f) monitoring the output signals from the onset of menstruation to identify: i) the case of concentration of estradiol or estrogen, a steady increase in concentration of estradiol or estrogen; ii) in the case of concentration of sodium CNa⁺) and chloride (CX) ions, a steady increase in concentration of sodium (Na⁺) and chloride (Cl^") ions; Hi) in the case of concentration of calcium (Ca²⁺) and potassium (K⁺) ions, a slight rise in concentration of calcium (Ca²⁺) and potassium (K⁺) ions; iv) in the case of pH, a steady decrease in pH; v) in the case of membrane potential, an increase in membrane potential; vi) in the case of conductivity, an increase in conductivity; and vii) in the case of capacitance, an increase in capacitance; wherein the properties identified, either alone or in combination, indicate that the female human is approaching the ovulation phase of a menstrual cycle.

99. The method as in claim 98, further comprising the step of comparing the levels indicated in step (b) with mean values of corresponding properties obtained in at least one previous menstrual cycle of the female human in identifying the changes listed in (c).

100. The method as in claim 99 wherein the levels indicated in step (c) occur after the tenth or more days from menstruation.

101. A method of predicting ovulation in a female human subject, which subject has experienced the onset of menstruation in her menstrual cycle, the method comprising the steps of: a. sensing invasively one or more of the properties selected from the group consisting of: i. temperature; ii. concentration of estradiol or estrogen in the fluid; iii. concentration of luteinizing hormone in the fluid; iv. concentration of sodium (Na⁺) and chloride (Cl^") ions in a fluid; v. concentration of calcium (Ca²⁺) and potassium (K⁺) ions in the fluid; vi. pH in the fluid; vii. membrane potential in the cells or tissues; viii. conductivity in the cells or tissues; and ix. capacitance in the cells or tissues of a reproductive organ of the female subject at least on a daily basis; b. generating output signals indicative of the levels of the properties sensed in step (a); and c. monitoring the output signals to identify: i. in the case of temperature, a rise in temperature from the levels at pre-ovulation; ii. in the case of concentration of estradiol or estrogen, a steady decrease in concentration of estradiol or estrogen; iii. in the case of concentration of luteinizing hormone, a peak in concentration of luteinizing hormone; 00737

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iv. in the case of concentration of sodium (Na⁺) and chloride (Cl^") ions, a sharp decline in concentration of sodium (Na⁺) and chloride (Cl^") ions from the levels at pre-ovulation; v. in the case of concentration of calcium (Ca²⁺) and potassium (K⁺) ions, an increase in concentration of calcium (Ca²⁺) and potassium

(K⁺) ions from the levels at pre-ovulation; vi. in the case of pH, a significant rise in pH from the levels at pre- ovulation; vii. in the case of membrane potential, a sharp rise in membrane potential from the levels at pre-ovulation; viii. in the case of conductivity, a sharp rise in conductivity from the levels at pre-ovulation; and ix. in the case of capacitance, a sharp rise in capacitance from the levels at pre-ovulation; wherein the properties identified, either alone or in combination, indicate that the female human is in the ovulation phase of a menstrual cycle.

102. The method as in claim 101, further comprising the step of comparing the levels indicated in step (b) with mean values of corresponding properties obtained in at least one previous menstrual cycle of the female human in identifying the changes listed in (c).

103. A method of predicting if no fertilization of an egg occurred post-ovulation in a female human subject, which subject has experienced the onset of menstruation in her menstrual cycle, the method comprising the steps of: a. sensing invasively one or more of the properties selected from the group consisting of: i. temperature; ii. concentration of progesterone in the fluid; iii. concentration of calcium (Ca²⁺) and potassium (K⁺) ions in a fluid; iv. pH in the fluid; v. membrane potential in the cells or tissues; vi. conductivity in the cells or tissues; and vii. capacitance in the cells or tissues of a reproductive organ of the female subject at least on a daily basis; b. generating output signals indicative of the levels of the properties sensed in step (a); c. determining the levels of the properties sensed in step (a) at ovulation; and d. monitoring the output signals after ovulation to identify: i. in the case of temperature, a decline in temperature from the levels at ovulation; ii. in the case of concentration of progesterone, an increase, then a peak, followed by a steady decline in concentration of progesterone from the levels at ovulation; iii. in the case of concentration of calcium (Ca²⁺) and potassium (K⁺) ions, a decline in concentration of calcium (Ca²⁺) and potassium (K⁺) ions from the levels at ovulation; iv. in the case of pH, a decline in pH from the levels at ovulation; v. in the case of membrane potential, a decline in membrane potential from the levels at ovulation; vi. in the case of conductivity, a decline in conductivity from the levels at ovulation; and vii. in the case of capacitance, a decline in capacitance from the levels at ovulation; wherein the properties identified, either alone or in combination, indicate that fertilization has not occurred in the female human.

104. The method as in claim 103, further comprising the step of comparing the levels indicated in step (b) with mean values of corresponding properties obtained in at least one previous menstrual cycle of the female human in identifying the changes listed in (c).

105. A method of predicting if fertilization of an egg occurred after ovulation in a female human subject, which subject has experienced the onset of menstruation in her menstrual cycle, the method comprising the steps of: a. sensing invasively one or more of the properties selected from the group consisting of: i. temperature; ii. concentration of progesterone in the fluid; iii. concentration of calcium (Ca²⁺) and potassium (K⁺) ions in a fluid; iv. pH in the fluid; v. conductivity in the cells or tissues; and vi. capacitance in the cells or tissues of a reproductive organ of the female subject at least on a daily basis; b. generating output signals indicative of the levels of the properties sensed in step (a); c. determining the levels of the properties sensed in step (a) at ovulation; and d. monitoring the output signals after ovulation to identify: i. in the case of temperature, an increase in temperature from the levels at ovulation; ii. in the case of concentration of progesterone, a steady increase in concentration of progesterone from the levels at ovulation; iii. in the case of concentration of calcium (Ca²⁺) and potassium (K⁺) ions, an increase in concentration of calcium (Ca²⁺) and potassium

(K⁺) ions from the levels at ovulation; iv. in the case of pH, an increase in pH from the levels at ovulation; v. in the case of conductivity, an increase in conductivity; and vi. in the case of capacitance, an increase in capacitance from the levels at ovulation; wherein the properties identified, either alone or in combination, indicate that fertilization has occurred in the female human.

106. The method as in claim 105 further comprising the step of determining the presence of sperm in the Fallopian tube wherein the presence of sperm in conjunction with the levels identified in (d) supports the indication that fertilization has occurred, and the absence of sperm indicates that no fertilization has occurred.

107. A method of predicting if a normal pregnancy is taking place after fertilization of an egg in a female human subject, the method comprising the steps of: a. sensing invasively one or more of the properties selected from the group consisting of: i. temperature; ii. concentration of progesterone in the fluid; iii. concentration of calcium (Ca²⁴) and potassium (K⁺) ions in a fluid; iv. pH in the fluid; v. conductivity in the cells or tissues; and vi. capacitance in the cells or tissues of a reproductive organ of the female subject at least on a daily basis; b. generating output signals indicative of the levels of the properties sensed in step (a); c. determining the levels of the properties sensed in step (a) at fertilization; and d. monitoring the output signals after fertilization to identify: i, in the case of temperature, a stabilization in temperature near the levels at fertilization; ii. in the case of concentration of progesterone, an steady increase in concentration of progesterone from the levels at fertilization; iii. in the case of concentration of calcium (Ca²⁺) and potassium (K⁺) ions, a stabilization in concentration of calcium (Ca²⁺) and potassium (K⁺) ions near the levels at fertilization; iv. in the case of pH, a stabilization in pH near the levels at fertilization; v. in the case of conductivity, a stabilization in conductivity near the levels at fertilization; and vi. in the case of capacitance, a stabilization in capacitance near the levels at fertilization; wherein the properties identified, either alone or in combination, indicate that a normal pregnancy is taking place in the female human.

108. A method of predicting if an abnormal pregnancy is taking place after fertilization of an egg in a female human subject, the method comprising the steps of: a. sensing invasively one or more of the properties selected from the group consisting of: i. temperature; ii. concentration of progesterone in the fluid; iii. concentration of sodium (Na⁺) and chloride (Cl^") ions in a fluid; iv. concentration of calcium (Ca²⁺) and potassium (K⁺) ions in the fluid; v. membrane potential in the cells or tissues; vi. conductivity in the cells or tissues; and vii. capacitance in the cells or tissues of a reproductive organ of the female subject at least on a daily basis; b. generating output signals indicative of the levels of the properties sensed in step (a); c. determining the levels of the properties sensed in step (a) at fertilization; and d. monitoring the output signals after fertilization to identify: i. in the case of temperature, a fluctuation in temperature from the levels at fertilization; ii. in the case of concentration of progesterone, a fluctuation in concentration of progesterone from the levels at fertilization; iii. in the case of concentration of sodium (Na⁺) and chloride (Cl^") ions, a fluctuation in concentration of sodium (Na⁺) and chloride (CY) ions from the levels at fertilization; iv. in the case of concentration of calcium (Ca²⁴) and potassium (K⁺) ions, a fluctuation in concentration of potassium (K⁺) ions and calcium (Ca²⁺) ions from the levels at fertilization; v. in the case of membrane potential, a fluctuation in membrane potential; vi. in the case of conductivity, a fluctuation in conductivity from the levels at fertilization; and vii. in the case of capacitance, a fluctuation in capacitance from the levels at fertilization; wherein the properties identified, either alone or in combination, indicate that an abnormal pregnancy is possibly taking place in the female human.

109. The method as claimed in any one of claims 98 - 108 wherein the step of sensing is carried out by one or more sensors and electrodes on a device that is implanted in a vessel, tube, duct or cavity of the female human subject.

110. The method as claimed in claim 109 wherein said device comprises a device as claimed in any one of the preceding claims.

111. An implant device for placement in a mammalian vessel to regulate fluid flow and

pressure through the vessel, the implant device comprising: 6 000737

173

an elongate tubular housing dimensioned for placement coaxially within the

lumen of the vessel;

a tubular conduit mounted within the housing, each end of which is sealed to

that is in fluid communication with the lumen of the vessel, and to define a

housing;

a valve mounted inline with the conduit and being operable for regulating the

fluid flow and pressure through the passageway;

one or more sensors on the housing or on the conduit for sensing

environmental information within the vessel;

one or more electrodes on the outer housing surface for stimulating contacted

vessel's luminal wall or endothelial cells within the vessel;

a source of mechanical energy mounted within the circumferential space and

coupled to the valve for moving the valve in response to a control signal from

controller; where source of mechanical energy means an actuator and or a motor,

and T/CA2006/000737

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controller means for providing a control signal to the source of mechanical

energy in response to a stimulus that originates externally of the implant device; and

controller further means for sensing and measuring environmental

information and sending stimulating voltage and current to electrodes at the outer

wall of the implant device.

112. The device as claimed in claim 111, further including a first source of electrical

mechanical energy to drive the valve.

113. The device as claimed in claim 112, wherein the first source of electrical energy

electrical energy for the actuator or motor.

114. The device as claimed in claim 112, wherein the first source of electrical energy

comprises a nano-battery .

115. The device as claimed in claim 112, wherein the first source of electrical energy

comprises a nano biothermal battery.

116. The device as claimed in any one of claims 113 to 115, further including a

transceiver antenna for receiving and transmitting wireless data signals, and wherein

the controller means comprises a control circuit connected to the antenna for

receiving the data of the wireless signal and translating the data into a control signal

to the actuator or motor for controlling the action of the actuator or motor to drive

the valve and for sensing and measuring environmental information and sending

stimulating voltage and current to electrodes at the outer wall of the implant device;

wherein intensity of stimulating voltage and current controlled by either internal

environmental information and in response to a stimulus that originates externally of

the implants device.

117. The device as claimed in claim 6, wherein the actuator or motor is a tubular

actuator or motor.

118. The device as claimed in any one of claims 6 and 7, wherein the control circuit is a

available space in the circumferential space in the housing.

119. The device as claimed in any one of claims 117 and 118, further including one or

more sensors and electrodes connected to the electronic control circuit for sensing

environmental information within the vessel and wherein the electronic control circuit includes preprogrammed instructions to measure and evaluate the

environmental information and send a control signal to the actuator or motor based

on the evaluation of the environmental information and or to transmit out and

sending stimulating voltage and current to said electrodes at the outer wall of the

implant device; wherein device sends stimulating voltage and current to electrodes

at the outer wall of the implant device and intensity of stimulating voltage and

current controlled by said control circuit based on either internal environmental

information and in response to a stimulus that originates externally of the implants

device

120. The device as claimed in claim 119, wherein the sensors comprise, in various

electrophysiological sensors, physical sensors and physiological sensors.

121. The device as claimed in claim 120, wherein at least one of said sensors is mounted

on the conduit within the fluid passageway.

122. The device as claimed in claim 121, wherein the sensors on the conduit are

recessed into the conduit wall so as to not obstruct any of the fluid passageway.

123. The device as claimed in claim 119, wherein at least one of said sensors is mounted

on a surface of the housing which, in situ, contacts a portion of the wall of the vessel.

124. The device as claimed in claim 119, wherein at least one or more electrodes are

mounted on the outer wall of the implant device so as to make physical

interconnection with implant device wall and internal luminal wall of the vessel.

1.25. An implant device for placement in a mammalian vessel, duct or tube to regulate

fluid flow and pressure through the vessel, duct or tube dilation and constriction, the

implant device comprising:

an elongate tubular housing dimensioned for placement coaxially within the

lumen of the vessel;

a tubular conduit mounted within the housing, each end of which is sealed to

that is in fluid communication with the lumen of the vessel, duct or tube and to

and the housing;

one or more sensors on me housing or on the conduit for sensing

environmental information within the vessel;

one or more electrodes on the outer housing surface for stimulating contacted

vessel's, duct's or tube's luminal wall or endothelial cells; 37

178

controller means for sensing and measuring environmental information and

sending stimulating voltage and current to electrodes at the outer wall of the implant

device.

126. The device as claimed in claim 125, further including a first source of electrical

energy located within the circumferential space and being connected to the control

circuit.

127. The device as claimed in claim 126, wherein the first source of electrical energy

electrical energy for the actuator or motor.

128. The device as claimed in claim 127, wherein the first source of electrical energy

comprises a nano-battery.

129. The device as claimed in claim 126, wherein the first source of electrical energy

comprises a nano biothermal battery.

130. The device as claimed in any one of claims 126 to 129, further including a

the controller means comprises a control circuit connected to the antenna for

receiving the data of the wireless signal and translating the data into a control signal 37

179

to stimulating electrodes and for sensing and measuring environmental information

and sending stimulating voltage and current to electrodes at the outer wall of the

implant device; wherein intensity of stimulating voltage and current controlled by

internal environmental information and in response to a stimulus that originates

externally of the implants device.

131. The device as claimed in any one of claims 125 and 126, wherein the control

circuit is a flexible longitudinal electronic control circuit that is bendable to conform

to the available space in the circumferential space in the housing.

132. The device as claimed in any one of claims 125 and 126, further including one or

environmental information within the vessel, duct or tube and wherein the electronic

control circuit includes preprogrammed instructions to measure and evaluate the

environmental information and sending stimulating voltage and current to said

electrodes at the outer wall of the implant device; wherein device sends stimulating

voltage and current to electrodes at the outer wall of the implant device and intensity

of stimulating voltage and current controlled by said control circuit based on either

externally of the implants device

133. The device as claimed in claim 132, wherein the sensors comprise, in various

electrophysiological sensors, electrodes, physical sensors and physiological sensors.

134. The device as claimed in claim 133, wherein at least one of said sensors is mounted

on the conduit within the fluid passageway.

135. The device as claimed in claim 134, wherein the sensors on the conduit are

136. The device as claimed in claim 119, wherein at least one of said sensors is mounted

137. The device as claimed in claim 119, wherein at least one or more electrodes are

mounted on the outer wall of the implant device so as to make physical

interconnection with implant device wall and internal luminal wall of the vessel-

duct or tube.

138. The device as claimed in claim 132 and 125, wherein stimulating voltage and

current is in Direct Current.

139. The device as claimed in claim 132 and 125, wherein stimulating voltage and

current is in any form of Alternating Current.

140. The device as claimed in claim 132 and 125, wherein stimulating voltage and

current is in any form of Pulsating Current.

141. The device as claimed in claim 125, wherein a valve mounted inline with the

conduit and being operable as secondary assisting for regulating the fluid flow

through the passageway along with stimulating dilation and or constriction of vessel,

duct or tube.