KR20010110556A - Artificial amnion device appropriate to organism - Google Patents

Abstract

The present invention relates to a biocompatible artificial amnion device. A balloon inserted into the amniotic cavity through the vagina and cervix and blocking between the permeation site of the amniotic membrane and the cervix; A first caterator inserted through the vagina and cervix and having an inner end located in the amniotic cavity and an outer end directed out of the vagina to inject amniotic fluid or drug into the amniotic cavity or to collect amniotic fluid; A second catheter inserted through the vagina and the cervix and having an inner end positioned in an inner cavity of the balloon and an outer end drawn out of the vagina to fill and take out fillers in the balloon; A cervical cap through which the first and second catheters are slidably moved in the longitudinal direction and inserted into and fixed to the boundary between the cervix and the vagina; And fixing means for fixing the cervical cap with respect to the first and second catheters, thereby preventing the birth of the amniotic fluid and preventing amniotic fluid by inserting a balloon into the amniotic cavity. Prevention of infection and cerebral palsy, and maternal and fetal mortality during perinatal period can be significantly reduced. In addition, complications such as antagonism and preterm labor can be excluded.

Description

Biocompatible Artificial Amniotic Device {ARTIFICIAL AMNION DEVICE APPROPRIATE TO ORGANISM}

The present invention relates to a biocompatible artificial amnion that can effectively reduce the complications and maternal and fetal mortality of newborns due to early amniotic membrane frequency.

In general, early amniotic membrane rupture refers to a symptom that the amniotic membrane surrounding the amniotic membrane ruptures before full-term birth and leaks amniotic fluid. Such early amniotic membrane rupture is reported to be about 3% of the total pregnancy, which causes the rupture of the amniotic membrane ( Cause is not yet clear, but so far known infection is the main factor.

ROMERO et al., A study on the mechanism of inflammation among the causative factors contributing to premature birth, suggest that endotoxin and acrophage of bacteria Cytokinin is secreted, and cytokinin and proteolytic enzymes dissolve the fetal membrane, prematurely causing amniotic membranes.

Premature analgesia is caused by bacterial infection caused by the same mechanism as early amniotic membrane rupture. It is known that infection accounts for more than 30% of the causes of early analgesia.

According to the research of the present inventors, more than about 40% of premature births are accompanied by early amniotic membrane frequency, and it was found that early amniotic membrane frequency is an important factor of premature birth.

Early amniotic membrane frequency is an important cause of premature birth. Complications of the newborn and maternal and fetal mortality due to premature birth are serious problems. According to the domestic study, the survival rate of premature infants at 28 weeks of pregnancy varies from 50% to 70%. .

Early amniotic membrane frequency may be due to bacterial infection, whereas early amniotic membrane frequency can have serious consequences for the fetus and mother by accompanying secondary intrauterine infection. In other words, early amniotic membrane frequency is caused by intravaginal invasion of intravaginal bacteria and is accompanied by amniotic chorionicitis or fetal sepsis, which increases maternal and neonatal mortality. Early amniotic membrane wave causes amniotic fluid leakage and is accompanied by amniotic amniotic fluid. Amniotic amniotic fluid causes fetal lung dysplasia or limb flexion. In addition, it is a flexible structure that connects the belly and fetus's navel with the placenta, and due to the compression of the umbilical artery and vein through the umbilical cord (臍帶) causes disorders of the placenta circulation and is accompanied by fetal distress.

The treatment of early amniotic membrane frequency up to now depends on the timing of the amniotic membrane frequency. In the case of full term, treatment is directed to lowering the chance of intrauterine infection by inducing immediate delivery. As a treatment method, there has been much controversy between expectant therapy for prolonging pregnancy for fetal lung maturation and active method for attempting to suppress intrauterine infection.

Most of the groups, including Parkland Hospital, insist on expectant therapy for prolonging pregnancy for premature amniotic membranes before 34 weeks of gestation. In this case, the treatment is administered by administering antibiotics while maintaining pregnancy until the 34th week of pregnancy. In other words, regardless of the premature rupture of the amniotic membrane during pregnancy, only antibiotics are administered until the 34th week of pregnancy. In Korea, since there is no such method for the prevention and treatment of early amniotic membrane frequency, expectation therapy is suggested as the main treatment method. In anticipation therapy, however, the use of antibiotics is a prophylactic antibiotic and controversy over its effectiveness.

Recently, amniotic fluid injection has been attempted for severe amniotic hyperplasia caused by premature amniotic membrane wave. However, amniotic fluid injected while the amniotic membrane is ruptured should be repeatedly injected because it is released through the cervix of uterus. Could not be a fundamental cure.

Recently, a method of artificially blocking the ruptured amniotic membrane area has been developed using the cervical Fibrin Ceal.

Fibril Ceal injections, called "Duproject", are currently on the market, but have been clinically analyzed to have many limitations in their effectiveness.

In addition, Oeguta Fence has been used to prevent the leakage of amniotic fluid by blocking the cervix.

This Oeguta Fence method inserts a double polycatheter into the uterus and prevents the cervix with two baluns. The cervix is open enough to cause) and premature labor.

As a result, as described above, the latest treatment trend for early amniotic membrane frequency is a conventional anti-expectatory treatment method centered on Parkland Hospital, and the most common treatment method is to stabilize the mother and improve fetal maturity until 34 weeks of pregnancy. ought.

Most of the major hospitals at home and abroad are treating early amniotic membrane rupture with this method, and whether or not antibiotics are used is a little controversial, but it is generally recommended to preventatively administer them.

The biggest problem of expectation therapy is that it can be accompanied by the occurrence of severe amniotic fluid hypoplasia and consequent fetal pulmonary insufficiency, limb flexion, and fetal death due to umbilical cord compression. In addition, the development of amniotic chorionicitis and fetal pulmonary disease due to intrauterine infection can be said to be a fundamental treatment limitation.

Amniotic fluid injection has been tried to prevent severe complications of amniotic fluid. However, as mentioned above, amniotic fluid injection in the state of ruptured amniotic membrane is not significant. Fibril Glue and Oeguta Fence, developed to prevent the leakage of amniotic fluid into the ruptured amniotic membrane, have significant significance in their effects, but problems such as infection and early analgesic complications and loss of effectiveness due to cervical dilation are not resolved. As a situation that is not widely used.

Recently, there have been reports of noncombustible infection caused by early amniotic membrane wave, which causes periventricular osteomalacia, and eventually cerebral palsy, and early diagnosis of intrauterine infection caused by early analgesia and early amniotic membrane wave has started to emerge as an important task. did.

Therefore, the object of the present invention is to prevent premature birth and amniotic fluid reduction, prevention of cerebral palsy following infection, continuous monitoring of intrauterine infection, and early analgesia and premature labor, which are the most common cause of maternal and fetal mortality in perinatal period. It is an object of the present invention to provide an early amniotic membrane therapy method and a biocompatible artificial amnion device for use in amniotic membrane therapy.

Another object of the present invention is to provide a biocompatible artificial amniotic membrane device which can prevent cervical hyperplasia and early analgesia by causing infection and stimulation of cervix and decidual membrane.

1 to 4B show a biocompatible artificial amniotic membrane device according to a first embodiment of the present invention,

1 is a partially disassembled exploded perspective view.

2 is a cross-sectional view of an installation state before the balloon is expanded.

3 is an enlarged view of part III of FIG. 2;

4 is an enlarged view of part IV of FIG. 2;

5 is an installation state sectional view of the balloon in an expanded state.

FIG. 6 is an enlarged view of part VI of FIG. 5;

FIG. 7 is an enlarged view of the upper part of FIG. 5; FIG.

8 is a partially cutaway exploded perspective view showing a biocompatible artificial amniotic membrane device according to a second embodiment of the present invention.

** Description of symbols for the main parts of the drawing **

10 balloon 11,12 inner and outer membrane

20: first caterer 21: entrance and exit

30: second catheter 31: entrance and exit

40: cervical cap 41: through hole

42: hydrogel layer 50: flexible tube

51: third catheter 52: entrance and exit

Balloon to be inserted into the amniotic cavity through the vagina and cervix to block between the membrane and the cervix of the amniotic membrane to achieve the object of the present invention; A first caterator inserted through the vagina and cervix, the inner end of which is located in the amniotic cavity and the outer end of which is drawn out to inject amniotic fluid or drug into the amniotic cavity or to collect amniotic fluid; A second catheter inserted through the vagina and the cervix and having an inner end positioned in an inner cavity of the balloon and an outer end drawn out of the vagina to fill and take out fillers in the balloon; A cervical cap through which the first and second catheters are slidably moved in the longitudinal direction and inserted into and fixed to the boundary between the cervix and the vagina; Provided is a biocompatible artificial amniotic membrane device comprising a; fixing means for fixing the cervical cap with respect to the first and second catheters.

The balloon has a cavity formed therebetween by inner and outer membranes, and the inner membrane has a thick central portion and gradually becomes thinner toward the edge.

The first catheters are formed thicker than the second catheters so that the second catheters are inserted into the first catheters so that the entrance holes at the tip of the second catheters are formed through the through holes formed in the circumferential wall of the first catheters. In communication with the interior.

The balloon is constructed by coating a hydrogel layer over the entire surface and the cervical cap at least in contact with the cervix.

The fastening means is fixedly coupled to the middle portion of the first catheters, and in the contracted state is loosely inserted into the through hole drilled in the central portion of the cervical cap, and in close contact with the inner circumferential surface of the through hole of the cervical cap. It consists of a flexible tube and a third caterator for injecting filler into the flexible tube.

The inner circumferential surface of the through hole of the cervical cap is formed with an uneven surface.

The third catheters are inserted into the first catheters and the entrance holes at the front end thereof communicate with the inside of the flexible tube through the main wall of the first caters.

Hereinafter, a method for treating amnion according to the present invention and a biocompatible artificial amniotic device used therein will be described as examples.

1 to 7 are views showing a biocompatible artificial amniotic membrane device according to a first embodiment of the present invention.

Before describing the device of the present invention, the biological structure will be described first.

In the figure, 1 is amnion cavity. The amniotic membrane cavity 1 is surrounded by the myometrial layer 2, and the amniotic membrane 3 is covered on the inner circumferential surface thereof. The outer side of the amniotic membrane (1) is connected to the cervix 4 and the vagina (5). The vagina 5 is surrounded by a vaginal wall 6.

The biocompatible artificial amnion device according to the present invention is a balloon inserted into the amnion cavity 1 as shown in FIGS. 1 and 2 to block a connection between the amnion cavity 1 and the cervix 4. 10, the first catheter 20 connecting the inside of the amniotic cavity 1 and the outside of the vagina 5, and the inside and the vagina of the balloon 10 through the cervix 4 A second catheter (30) connecting the outside of the 5) and a cervical cap (40) through which the first and second catheters (20, 30) are closed and the cervix (4) is closed; And fixing means for fixing the cervical cap 40 to the first catheter 20.

The balloon 10 is formed of, for example, a urethane material, and has a structure in which a cavity 13 is formed inside the outer peripheral portions of the inner and outer membranes 11 and 12.

Surfaces of the inner and outer membranes 11 and 12 of the balloon 10 are preferably coated with a hydrogel layer 15. In particular, the surface of the inner membrane 11 in direct contact with the amniotic fluid of the inner and outer membranes 11 and 12 may form a hydrogel layer.

The hydrogel is usually made of 95% water and 5% plastic and is used as an artificial organ.

The balloon 10 is larger than the cervix 4 when it is contracted to a size that can pass through the vagina 5 and the cervix 4 and is fully expanded in the state of being inserted into the amniotic cavity 1. It is formed to form a sphere.

For example, the balloon 10 is manufactured to have a diameter of about 7cm and a thickness of about 1cm when expanded by injecting physiological saline.

Through-holes 11a and 12a are formed in the central portion of the inner and outer membranes 11 and 12.

In addition, the inner membrane 11 of the balloon 10 has a thick central portion and is gradually thinner toward the edge. This is to ensure that the balloon 10 is generally dish-shaped without the bulging of the central portion of the inner membrane 11 when a filler such as physiological saline is injected into the balloon 10.

The first catheters 20 are for collecting and inspecting amniotic fluid in the amnion steel 1 or injecting a chemical solution into the amnion steel 1, and are formed of a flexible and flexible material such as silicone rubber. The stage is installed to penetrate through the through-holes (11a, 12a) of the balloon 10 in the amnion steel (1) and the outer end is located outside the vagina (5).

The first catheters 20 are inserted through the through holes 11a and 12a formed at the centers of the inner and outer membranes 11 and 12 of the balloon 10, and the outer circumferential surfaces thereof are the inner and outer membranes 11 and 12. Is fixed to the inner circumferential surfaces of the through holes 11a and 12a.

The inner end of the first catheter 20 is blocked and the entrance and exit hole 21 is formed in the peripheral wall thereof, the outer end is open and the connector 22 is provided to connect a syringe or the like.

The connector 22 may be integrally formed, or may be manufactured separately and fixed by bonding. The connector 22 is normally closed by a clip or a check valve (not shown), and is to be opened only when connecting a syringe or the like.

A through hole 23 communicating with the cavity 13 is formed at a portion of the circumferential wall of the first catheter 20 that is located inside the cavity 13 of the balloon 10.

A through hole 24 is formed in an approximately middle portion of the first catheter 20.

The second catheters 30 are catheters 30 for injecting physiological saline into the balloon 10, and are formed of a flexible and flexible material such as silicone rubber, and an inner end of the balloon 30. It is located in the cavity 13 of (10) and the outer end is provided so that it may be located outside of the vagina (5).

The inner end of the second catheter 30 has an entrance and exit hole 31 is formed to inject or discharge physiological saline into the cavity 13 of the balloon 10, the outer end of the vagina (5) Is drawn out to the outside end is connected to the connector 32 is formed so as to connect the syringe. The connector 32 is normally closed by a clip or a check valve (not shown), and is to be opened only when connecting a syringe or the like.

The second catheter 30 is coupled to the balloon 10 separately from the first catheter 20 so that the first catheter 20 and the second catheter 30 are two strands from the balloon 10. Although it may be installed in an extended state, as shown in the illustrated example, the first catheters 20 are formed relatively thick and the second catheters 30 are formed relatively thin, thereby forming the second catheters 30 as the first catheters 20. It is advantageous in handling that the first catheters 20 and the second catheters 30 extend in one strand from the balloon 10 by insertion into the.

That is, the second catheter 30 has a through hole 23 in which an inner end of the second catheter 30 is perforated in the circumferential wall of the first catheter 20 while being inserted into the first catheter 20. It is inserted in the airtight state so that the entrance / exit hole 31 is always located in the cavity 13 of the balloon 10.

The cervical cap 40 is formed of silicone rubber or urethane, and is formed in a substantially disc shape, and its edge is curved inwardly so that the cervical cap 40 is inserted into and fixed to the cervix 4. Maximize the resistance of the cervix 4 with the inner wall so that the cervical cap 40 is not drawn from the fixed position to the amniotic cavity 1 side, and the cervical cap 40 is removed from the cervix 4. When withdrawn, the resistance with the vaginal wall 6 is minimized so that the cervical cap 40 can be easily withdrawn.

A through hole 41 is formed in the center of the cervical cap 40 so that the first catheter 20 is slidably inserted through the through hole 41.

The fixing means is covered in an airtight state to the stop portion of the first catheter 20 and the flexible tube 50 is located in the through hole 41 of the cervical cap 40, the inner end is the elastic The entrance and exit hole 52 is formed in the interior of the tube 50 to communicate with the inside of the flexible tube 50, the outer end is located outside through the vagina (5) and the connector 53 so as to connect a syringe, etc. It is composed of a third catheter 51 provided with.

Since the distance from the boundary between the amniotic cavity (1) and the cervix (4) to the boundary between the cervix (4) and the vagina (5) varies from mother to mother, the position and length of the flexible tube (50) is statistically maternal. Set the position and length of the first catheter 20 to accommodate a range of distances from the boundary between the amniotic cavity 1 of the cervix and the cervix 4 to the boundary of the cervix 4 and the vagina 5 It is.

In the contracted state, the flexible tube 50 is loosened with respect to the through hole 41 of the cervical cap 40 so that the cervical cap 40 is positioned at the position of the elastic tube 50. The slide in the longitudinal direction of the, in the expanded state is in close contact with the inner circumferential surface of the through hole 41 of the cervical cap 40, the cervical cap 40 in the longitudinal direction of the first catter 20 It is formed in such a size that the slide cannot be moved.

On the other hand, the inner circumferential surface of the through hole 41 of the cervical cap 40 is formed as a concave-convex surface, when the flexible tube 50 is expanded, the flexible tube 50 is deformed into a concave-convex shape according to the concave-convex surface first The relative movement of the cervical cap 40 and the first catheter 20 in the longitudinal direction of the catheters 20 can be prevented more reliably.

The third catheter 51 may be connected to the flexible tube 50 through the vagina 5 separately from the first and second catheters 20 and 30. Inserted together with the second catheters 30, the front end portion thereof penetrates through the through hole 24 formed in the circumferential wall of the first catheter 20 so that the entry and exit hole 52 communicates with the inside of the flexible tube 50. It is advantageous in handling.

The connector 53 is normally closed by a clip or a check valve (not shown), and is to be opened only when connecting a syringe or the like.

Hereinafter, the operation of the biocompatible artificial amnion device according to the present embodiment will be described.

As shown in Figure 1, the cervix (4) and the vagina (5) at the boundary between the amnion cavity (1) and the cervix (4) of the mother to be performed in a state in which the balloon (10) and the flexible tube (50) contracted Fit the distance of the balloon 10 and the cervical cap 40 to the distance to the boundary of the) and secure the cervical cap 40 with a fixing means.

In fixing the cervical cap 40 to the first catheter 20 by fixing means, a syringe or the like is connected to the connector 53 of the third catheter 51 and a liquid such as physiological saline is injected. When the injected liquid such as physiological saline flows through the third catheter 51 and flows into the flexible tube 50 from the entrance hole 52 formed at the front end of the third catheter 51, the flexible tube 50 is provided. As shown in FIGS. 5 and 7, the flexible tube 50 is in close contact with the inner circumferential surface of the through hole 41 of the cervical cap 40, so that the cervical cap 40 is the flexible tube 50. It is fixed to the first catheters 20 through. When the injection of the filler, such as saline is completed, the connector 53 is closed by using a clip. In addition, when the check valve is installed in the connector 53, it is automatically closed by removing the syringe.

The balloon 10 and the cervical cap 40 are inserted through the vagina 5 and the cervix 4 so that the balloon 10 is placed in the amniotic cavity 1 and the cervical cap 40 is the cervix ( 4) and the vagina (5) at the boundary. At this time, the connector 22, 32, 53 of the first, second, third catheters (20, 30, 51) is located outside the vagina (5). The first, second and third catheters 20, 30 and 51 are closed by clips. Alternatively, when the check valves are installed in the connecting holes 22, 32, and 53 of the first, second, and third catheters 20, 30, and 51, they are always kept closed.

Here, since the first, second, and third catheters 20, 30, and 52 are formed of silicone rubber and are easily bent, they are difficult to be inserted into the uterus by themselves, so they are thin through the first catheters 20. A relatively rigid synthetic resin rod (not shown) is inserted to insert the first, second, and third catheters 20, 30, and 51 so that they are not easily bent.

In this state, when a syringe or the like is connected to the connector 32 of the second catheter 30 and the liquid such as physiological saline is injected into the balloon 10, the balloon 10 is injected into the liquid such as physiological saline. 5 and 6 to expand and unfold at the boundary between the amniotic cavity 1 and the cervix 4. When the injection of the filler, such as saline is completed, the connector 32 is closed by using a clip. In addition, when the check valve is installed in the connector 32, it is automatically closed by removing the syringe.

As such, when the balloon 10 is unfolded at the boundary between the amniotic cavity 1 and the cervix 4, the boundary between the amniotic cavity 1 and the cervix 4 is blocked to prevent the amniotic fluid from leaking from the perturbed amniotic membrane. You can do it.

At this time, since the inner membrane 11 of the balloon 10 is formed to become thicker and thinner toward the edge, the inner membrane 11 does not bulge inflated and the balloon 10 is generally maintained in a substantially plate shape. The amniotic membrane portion at the boundary between the amniotic cavity 1 and the cervix 4 can be reliably blocked.

On the other hand, since the inner end of the first catheter 20 is located inside the amnion cavity 1, insufficient amniotic fluid can be injected through the first catheter 20.

At this time, the injection of amniotic fluid prevents the pressure in the amniotic cavity 1 from increasing to 60 mmHg or more, and the pressure in the amniotic membrane may be continuously monitored through the first catheter 20. The monitoring of the pressure in the amnion steel (1) can promote the generalization of the product by connecting a separate pressure measuring device, but can be used exclusively for measuring the pressure in the amnion steel (1) in the future. (Portable Polygraph) will be developed.

In addition, in order to check whether the infection in the amniotic cavity (1), the amniotic fluid (1) can be collected in the amniotic cavity (1) through the first catheters (20) and culture and leukocyte test can be performed.

As such, the mother is able to perform normal activities for four weeks while the biocompatible artificial amniotic membrane device according to the present invention is installed.

In addition, in the conventional method of treating early amniotic membrane wave number, hospitalization treatment for 1 month to 2 months was required in many cases, but according to the biocompatible artificial amniotic membrane device according to the present invention, it is necessary to install and to inject physiological saline. The time is very short, about 10 minutes, and you will be able to stay home and stay in pregnancy as soon as the treatment is complete.

In addition, the conventional treatment of early amniotic membrane can be performed only in general hospitals, such as university hospitals, but according to the biocompatible artificial amniotic membrane device according to the present invention can be easily performed in individual obstetrics and gynecology hospitals can greatly reduce the economic and time burden of patients Will be.

In addition, the foreign body usually installed in the uterus inevitably causes an infection and inflammatory reactions. The balloon 10 and the cervical cap 40 are not only excellent in biocompatibility but also coated with a hydrogel that is a biodegradable material. Inflammation will not be induced, and in vitro experiments showed that bioactivity was possible for four weeks.

In addition, by inducing lateral secretion by a progesterone releasing system (Progestrone Releasing System) for administering progesterone through the first catheters (20) can increase the suppression of the intrauterine immune activity. The effectiveness of this progesterone releasing system has already been demonstrated by Th1 / Th2 studies and is at a level that requires quantitative study of future doses. In addition, progesterone inhibits the production of cytokinin and prostaglandine in the fetal membrane by lateral secretion in human fetal membrane and is known to act to inhibit the activation of Oxytocin Receptor.

In actual animal experiments, progesterone administered to the cervix significantly inhibited the maturation of the cervix (maturation of the cervix to become soft and thin to adapt to childbirth and progression from closed to open). It has been shown to inhibit the change of the composition ratio of cervical collagen / Hydronic Acid component by progesterone.

Therefore, it is analyzed that the biocompatible artificial amniotic membrane device according to the present invention is capable of sustaining pregnancy for about 8 weeks by exchanging the applicable time of the intrauterine device by immunosuppressive ability up to 4 weeks once.

In addition, the insertion of the balloon 10 into the amniotic cavity 1 alone can sufficiently suppress the leakage of amniotic fluid without changing the cervix for a certain period of time. And in order to minimize the amniotic fluid leak that may occur according to the activity can be improved by the use of the fibrin glue agent to the contact surface of the balloon 10 and the amnion (3) to supplement the amniotic fluid leakage.

If fibrin glue is used as an adjuvant, it maintains adhesive surface sealing ability for 3 ~ 4 weeks, but is gradually biodegraded and absorbed. After 4 weeks of use of artificial amniotic membrane, the artificial amnion can be exchanged to maintain the pharmacological action of progesterone.

Furthermore, by installing a balloon in the amniotic cavity without directly installing a balloon in the cervix, it is possible to directly block the ruptured amniotic membrane. It becomes possible.

Meanwhile, in removing the biocompatible artificial amnion device according to the present invention, a syringe is connected to the connector 32 of the second catheter 30 connected to the balloon 10, and the physiological saline injected into the balloon 10 is used. The filler 10 is taken out so that the balloon 10 contracts, and when the first catheter 10 is pulled out, the balloon 10 is coupled to the first catheter 20 and the cervical cap 40 is fixed to the fixing means. As a result of being fixed to the first catheter 20, both the balloon 10 and the cervical cap 40 can be withdrawn.

In addition, Figure 8 shows a second embodiment of the present invention, by coating the hydrogel layer 42 on the surface of the cervical cap 40 so as not to cause infection and inflammation, and other components Are the same as in the above-described first embodiment, the same reference numerals are assigned to the same parts, and detailed description thereof will be omitted.

As described above, according to the present invention, by inserting a balloon into the amniotic cavity, the amniotic fluid is prevented from leaking even during early amniotic membrane. Will be reduced. In addition, complications such as antagonism and preterm labor can be excluded.

Claims (7)

A balloon inserted into the amniotic cavity through the vagina and cervix and blocking between the permeation site of the amniotic membrane and the cervix; A first caterator inserted through the vagina and cervix and having an inner end located in the amniotic cavity and an outer end directed out of the vagina to inject amniotic fluid or drug into the amniotic cavity or to collect amniotic fluid; A second catheter inserted through the vagina and the cervix and having an inner end positioned in an inner cavity of the balloon and an outer end drawn out of the vagina to fill and take out fillers in the balloon; A cervical cap through which the first and second catheters are slidably moved in the longitudinal direction and inserted into and fixed to the boundary between the cervix and the vagina; And a fixing means for fixing the cervical cap with respect to the first and second catheters. The biocompatible artificial amnion apparatus according to claim 1, wherein the balloon is formed between the inner and outer membranes, and the inner membrane has a thick central portion and gradually becomes thinner toward the edge. The biocompatible artificial amnion apparatus according to claim 1, wherein the balloon is formed by coating a hydrogel layer on the entire surface and the cervical cap at least in contact with the cervix. According to claim 1, wherein the first catheters are formed thicker than the second catheters to insert the second catheters into the interior of the first catheters, so that the entrance hole of the tip of the second catheters formed in the circumferential wall of the first catheters The biocompatible artificial amnion device, characterized in that communicating with the interior of the balloon through the through-hole. The cervical cap of claim 1, wherein the fixing means is fixedly coupled to an intermediate portion of the first catheter and is loosely inserted into the through hole drilled in the central portion of the cervical cap in the contracted state and in the expanded state. A biocompatible artificial amnion device, characterized in that it comprises a flexible tube in close contact with the inner circumferential surface of the through hole and a third caterator for injecting a filler into the flexible tube. The biocompatible artificial amniotic membrane device according to claim 5, wherein the inner circumferential surface of the through hole of the cervical cap is formed of an uneven surface. The biocompatible artificial amnion according to claim 5, wherein the third catheters are inserted into the first catheters and the entrance holes of the third catheters communicate with the inside of the flexible tube through the circumferential wall of the first catheters. Device.