MXPA96005629A - Apparatus and procedure for transfertral therapy centrated in ultrasoni - Google Patents

Abstract

The present invention relates to an apparatus and method for the treatment of diseases of the prostate, including BPH and prostate cancer, using concentrated ultrasound energy applied transurethrally to produce hyperthermic and thermotherapeutic effects in diseased tissue; The preferred embodiment of the apparatus is based on visual control, and a second preferred embodiment of the apparatus incorporates an integrated ultrasonic therapy and imaging transducer, the apparatus and method presenting the proximal placement of the ultrasound transducer to the tissue Sick to treat, resulting in less beam attenuation and deposition of a larger fraction of the total ultrasound energy emitted in the selected portion of diseased tissue, the ultrasound energy es non-traumatically through the urethral wall and other non-focused tissue, at the focal point of the ultrasound, there is a considerable warming of the diseased tissue to produce hyperthermic effects in it, and even higher thermotherapeutic temperatures are reached to produce the coagulative necrosis of the diseased tissue

Description

APPARATUS AND PROCEDURE FOR TRANSFERTRAL THERAPY CENTRATED IN ULTRASOUND BACKGROUND OF THE INVENTION This invention relates to an apparatus and method for the treatment of benign prostatic hyperplasia (BPH), prostate cancer, and other diseases, by the application of concentrated ultrasonic energy through a probe placed in the vicinity of the site of the injury. BPH is a very common disease in men over 50 years of age, in whom dilatation of the prostate results in obstruction of the urethra and consequent inability or difficulty to urinate. In its earliest stages, it causes discomfort and inconvenience. If it is allowed to advance, it can result in severe pain and serious consequences. This has traditionally been treated by transurethral resection of the prostate (TURP), a surgical procedure of good effectiveness but an unfortunate level of pain, blood loss, morbidity, complications, expenses, loss of time and, in some cases, death. Other procedures, which use lasers or radiofrequency or microwave energy, have not been shown to approach the TURP in terms of effectiveness. A method that combines high effectiveness with less bad effects in the short term than with rURP is urgently needed.

Fl nancer pios'ata os the second cause of deaths related to cancer in men. In its early stages, I can be successfully treated with radical care, but this has all the disadvantages of TURP and also results in incontinence, impotence or both as a result. The prostate can be treated by means of radiation therapy, but similar serious side effects are usual if a sufficient dose is used to have a good chance of obtaining a favorable result. A total cure is needed with less initial trauma. 1-11 more advanced prostate cancer is also treated by radical pro teteotomy or radiation therapy, but this procedure does not usually result in healing, although its attenuation may be achieved. Since less is achieved in these cases, a less invasive method is even more necessary. Ultrasensives are well known to urologists for their ability to represent a volume of tissue, creating graphical partitions without the need for cutting. This can be done - because ultrasonic waves are transmitted through the tissue without being too strongly attenuated; however, since there is significant absorption by tissue delivery, intense ultrasound can produce a very considerable heating inside an organ. The objective of the promotion of this effect is to create a high intensity of ultrasound in the internal area to be treated while minimizing the intensity in the tissue that it must dispense with. previous use- the ability of concentrated ultrasound for the treatment of T1PH and cancer of the prostate .. A tentative use of extracorporeal asonidos concented from the outside of the body, ot a uses a probe ransrect t .. The Patent U.S. Patent No. 5,344,435 to Turner et al., Describes the transurethral application of concentrated ultrasound energy for the treatment of prostatic disease The described apparatus, however, does not take advantage of the ultrasonic capacity for ultrasound. to achieve a focus within the tissue, and therefore does not deliver a greater intensity at an internal point than that present in the urethral wall.As a consequence, and despite the use of urethral cooling, the ores do not recommend a temperature higher than 48 ° C. The use of these temperatures diffusely in the prostate may be of some clinical value, but the application of higher temperatures to an accurately defined tissue volume does not produce comparable effects., such as the present invention. The apparatus of the '435 document of Turnei et al., Works in what is generally known as hypertepanic. The transfer of the energy used in the document Turner et al. '435 is done by radiation, that is, the energy is transmitted from an internal source to the apparatus to a much higher volume of treatment than the energy. own? uonte. As a consequence of limiting the power of the i-radiap on luper t ^? my ua to a maximum do +. '! ° C, the diseased tissue should be irradiated for relatively long periods of time, often up to 60 minutes or more. This is a disadvantage because it requires the patient to be immobilized during such long treatment sessions. When a transverse probe is used, ultrasound must pass through 4 cm or more of healthy tissue before reaching the tissue to be used. If the probe is by force of the body, the ultrasounds must pass-even through a greater thickness of healthy tissue. In any case, the great distance between the probe and the tissue to be tethered is a disadvantage since it increases the difficulty of aiming the ultrasound accurately, since the healthy one is exposed to the potent effects. detrimental to the high intensity of ultrasound, and that a high initial power should be used to compensate for tissue attenuation between the probe and the target. A further drawback of the above systems is that they concentrate the ultrasound at the maximum intensity on each individual volume of tissue to be treated. This needs to be noted in an extremely exact manner, generally requiring an elaborate and expensive approach system such as diagnostic ultrasound. In addition, it requires the piovision of a precise relative movement between the probe and the patient. Because of the high power required to compensate for attenuation, and due to the required precise focus, the prior art systems are extremely} <;, rings, costing $ 100,000 and in some cases, many times more.

BRIEF DESCRIPTION OF THE INVENTION The broad main objects of the present invention are to provide a device capable of treating BPH, prostate cancer and other diseases by the application of high intensity ultrasound; allow the treatment to be minimally traumatic avoiding the incision of some tissue and entering only a single body cavity; minimize the damage to any tissue other than the one to be treated; minimize the necessary power output from the device so that unnecessary heating of nearby tissue is avoided; simplify the control procedure using direct endoscopic visualization as far as possible; minimize the cost of treatment; allow treatment without the requirement of anesthesia beyond topical agents such as lidocama, so that the procedure is no more painful or acutely traumatic than the examination with a flexible cystoscope; allow a treatment in which the urethra is not allowed to warm up, and the testation of the prostatic parenchyma is well controlled; and allow a treatment in which the subsequent catheterization is unnecessary - to the procedure, and such that the patients without features? ue < They are triaged in a facility that provides medical services such as a hospital, a clinic or even in a doctor's office, on an outpatient basis. A further specific object of the present invention consists in the provision of a compact, inter-cellular device, which produces a concentrated beam of ultrasound energy, and which uses a single ultrasound probe consisting of one or more piezoelectric elements. The device is capable of causing temperatures higher than the hyperthermic therapeutics in the selected areas of diseased tissue of a body organ in a particular area of the body, without causing the temperature surrounding the non-diseased tissue or of the anatomical areas adjacent to it increase to harmful levels, thereby allowing the device to be much simpler to be able to exempt from the need for means of cooling the organs and adjacent non-diseased tissue that is not being treated, to avoid the thermal damage of it. The device is also capable of performing a therapy process in a shorter period of time than is needed for a therapy process that uses ultrasound radiant energy not concentrated in a hypothetical operating mode that has a limit of maximum peratuia much lower, as necessary to avoid damaging the surrounding tissue not in eimo and other anatomical ai cas. Another additional specific object of the present invention consists in the provision of a conditional ultrasound device for the treatment of TJHP and other diseases of the implant, which possesses the above characteristics, and which due to the process of faster therapy, be of simpler design than a device for thermal hype treatment, and that this enabled to exempt from the need for a urinary drainage system due to the much shorter period of time that the device needs to be present in The prostrate urethra of the patient during the administration of a therapy process. The present device, in fact, when positioned operatively, does not need to extend beyond the prostatic urethra, either to the neck of the bladder or even into the bladder itself. The new aspect and the procedure of this invention are based on a therapeutic modality that has been called Transurethral Ultrasound Therapy (TUT). This treatment modality uses the application of concentrated energy of asons to the prostate from a probe in the prostatic urethra to perform hyperaneous heating or over the hypertext of the selected prostate tissue to be treated, causing the coagulative necrosis of the tissue in question, the great advantage of the apparatus according to the present invention using the IUT and the superiority of the geometrical aspects of the treatment.; the ultrasonic energy wave only has to move about 1 cm through the tissue. This is approximately the fourth delivery in relation to the rans-rectal application and represents an even greater advantage over the ext-racer-poral application. The geom eric factors resulting from the use of the present invention using the therapeutic modality TUT, allow the ultrasound energy to concentrate in a defined volume of tissue, directing from the source a minimum intensity to the most distant tissue. There is a much lower attenuation in this short path, so the probe does not need to emit a large excess of ultrasound energy to compensate for the attenuation. At the same time, the non-diseased tissue closest to the energy source is not affected, since the intensity of the ultrasound energy in those areas is low. Since the TUT probe resides in the urethra, direct cytoscopic observation is a great help in locating the probe, eliminating the need for more expensive control systems. Furthermore, while some transurethral devices may be uncomfortable, the improved geometry of the apparatus of the present invention allows a small non-traumatic probe to be used. Fl apar-ato TUT therefore combines the high effectiveness with the low mvasivity similar to the flexibLe cytoscopy, which is usually done only with topical lidoc gelatin. There are certain added advantages of the operation of the present apparatus, using a concentrated beam of ultrasound energy, of high intensity. An advantage is that higher therapeutic temperatures can be reached in defined areas more precisely in the interior of the prostate than those achieved with conventional hyperthermic treatment. Since these areas are separated from anatomical zones where higher temperatures can cause damage, there is no need for the device to provide cooling for these other anatomical areas. Therefore, the present apparition also offers the advantage of allowing the attainment of a high temperature where it is needed, while allowing the maintenance of lower, safer temperatures in the ci r-cunda t areas. Another advantage of the present apparatus is that at the highest therapeutic temperatures achievable with concentrated ultrasound in the limited area of the diseased tissue, the duration of the treatment is considerably shortened in relation to the time required for the typical hypertheric treatment process. conventional. An additional benefit of the shorter treatment time using the present apparatus is that a system of draining the urine into the bladder as part of the present apparatus is not required. On devices that use the LG conventional treatment, such conventional asthenia, drainage asthenia? The urinal is necessary to eliminate the accumulation of 01 which forms in the patient's bladder after a long treatment session. Therefore, the present apparatus still has the additional advantage of being of considerably simpler construction and of being easier to manufacture without requiring means of irrigation adjacent to the tissue or means for draining the urine, although in certain Cormas. In the embodiment of the apparatus, one or both of these characteristics may optionally be present. The use of a concentrated beam of ultrasound energy in the present apparatus also makes it possible for the apparatus to be constructed using a single ultrasonic transducer consisting of one or more rich piezoeleet elements, which is to the contrary that in devices of the type of ultrasonic radiation applicator requiring a plurality of transducers to produce an ultrasound energy field capable of being radiated simultaneously in many directions, usually omnidirectionally, to a volume considerably larger than the volume adjacent to the source. All of the above characteristics and advantages of the present invention are not found in the various apparatuses of the known prior art. Accordingly, it is considered that the apparatus of the present invention satisfies the need I 1 existing in the technique of * to the apparatus, and leale.a a new and innovative to the unique in this u000a BREVF nrSCRJPCION l) F THE DIBU10 * Fig. 1 shows a model of emission of asons from a circular aperture of an ultrasonic probe according to the present invention; Figure 2 shows a pre-drilled embodiment of the apparatus according to the present invention in an aerial perspective; Figure 3 shows a housing for ultrasonic transducer according to the present invention; Figure 4 shows a cross-sectional view through A-A of the housing of Figure 3; Figure shows a cross-sectional view of the birds of D-B of the housing of Figure 1; Figure 4 shows a detailed view of an embodiment of the ultrasound probe of the apparatus of Figure 2, including the transducer, the focusing means and the coupling means; Figures 6B-6D show alternative embodiments of the transducer, focusing means and / or coupling means of the ultrasound probe means of the present invention; Figure 7 shows a concentrated beam of ultrasound that is emitted from the ultrasound probe of the Fiura (> / Figure II shows a second preferred embodiment of the apparatus according to the present invention with a probe t r -surgery ral of ultrasound imaging.

DESCRIPTION DFTA1 LAPA DF THE PREFERRED EMBODIMENTS OF THE INVENTION The heating effect of ultrasound depends on the intensity, or power per unit area, of ultrasound. When the ultrasound is focused on a point whose area is small, the intensity is correspondingly high. If the same total power is spread over a larger area, the intensity is correspondingly lower. The amount of heat generated at a point in the tissue, and therefore the resulting increase in temperature, is generally proportional to the intensity of ultrasound at the point. The TUT apparatus of the present invention or a probe in the urethra very close to the tissue to be treated, the important advantage of being able to handle the diseased tissue from such proximity, is that a large relative opening can be used. The relative aperture, n, is defined as the focal length divided by the diameter of the aperture through which the ultrasound energy is emitted. If a small value of n is used, the i '! intensity of ultrasonic energy <-n the focus is much greater than the intensity most to the abertui or more to the focus area. As a result, the distal tissue of the focus is not affected. This is expressed quantitatively by the following formula, which considers the ultrasonic enunciation from the circular aperture 4 of the ultrasound probe 6, of Figure L. The aperture 4 has a diameter A and an area (? / 4) A2, and is in contact with the surface 8 of the tissue, the emitter probe is of a conformed configuration which causes the beam 10 of ultrasound energy to concentrate at a distance f from the focal plane 14 in the tissue. If the power emitted from the opening is U wat ios, the initial io intensity, or power per unit of area, is given by: In the plane 18 at a distance x from the opening, or f-x from the focaL plane, the volume of tissue exposed to ultrasound has a circular cross-section of area r (ir / 4) A21. C (f-x) / f] 2"Therefore, the intensity in x is given by1 :: L? = U / rc go / 4) G. (t -?) / fi2i in the absence of attenuation .. The ultrasound energy is actually cured, unwelcome, as it passes to the tissue, so that Ix: "U.expr-μxl / r (-? Í / 4) G (f - x) / f I21 [•> where u is the attenuation per unit length, and has a numerical value of approximately 0.16v crn-, if v is the frequency expressed in megahevs (MHz), FL area of the exposed tissue in the focal plane 14 does not fall to zero, as suggested by these equations, I igur-a 1 shows that the focus is not infinitely penetrating. In the focus, the diameter of the exposed tissue is given by diffraction theory as 1.2 n, where n is the relative aperture defined above, and is the length of wave of ultraso gone; In tissue, its approximate numerical value is l, S / v, if v is expressed in 111-lz "I to focal intensity If is given by; If -?. Ex C- uf) / r ('ir / 4) p, 2n 1 1 20 These equations show that the relation of intensity in the focus with respect to the intensity emitted by the luminance is given by-. if / io xp (-j f) / p,? n / H12 Similarly, the ratio of the intensity to a distance (f -x) ^ \ the focus with respect to the intensity in the focus lx / if = exp [-u (x-f) J. [L, 2n í / 0 (f x) 12 In this way, in order to minimize the intensity in the healthy tissue while it is being treated as a gift < As far as possible near the focus on the tissue to be treated, it is best to use a small relative aperture and a short focal length. The focal point should be in the tissue to be treated, so that the focal length is approximately equal to the distance from the probe to the tissue to be treated. In other countries, the probe should be as close as possible to the target. This configuration reduces the attenuation and eliminates the need for very high power from the probe. The small relative aperture causes the intensity to be substantially less at a distance from the focal point. Placing the probe in the urethra, about four times closer to the tissue to be treated than with the transrectal procedure, is the only way to satisfy these two requirements in the case of prostate therapy, the first embodiment Preferred described below, has a focal length of 12 rnin and an aperture of 0 rnm, for a relative aperture of 1.5. When operating at a frequency of 5 NHz and emitting an ultrasound power of Ib wat ios, -, e deliver more than 1600 wat i os / o? N2 ..? L focal point ,, With t, in order to entige this high power to the focus, a transducer that operates at 11Hz, at 40 min from the focal point, it would have to emit about 60 watts of power from ultrasound. At this level of power it could not be acted continuously for a long enough time to produce extensive coagulation without a system of irrigation that would not be practical for use on the inside of the body. For better results, the relative aperture should not be more than 1.7 and the focal length not more than 20 nm. A relative aperture, n, of 1.7 is often indicated with a f / 1.7 optic. An additional advantage of the invention is that it makes it possible to use a higher frequency of ultrasound. The length of the lesion, in a direction parallel to the direction of propagation of the ultrasound, is proportional to the depth of focus. But the depth of focus os, in turn, inversely proportional to the frequency of ultrasound. Therefore, the use of a low frequency tends to produce an elongated lesion, which is disadvantageous since the cold can be heated in critical areas, with danger of damage to the patient. The anatomical areas exposed to risks by a large depth of field, and therefore by a low frequency of ulcers, include the prostatic capsule, the anterior rectal wall, the external sphincter, and the neurovascular bundle. For this reason 1 ( it is desirable to use a frequency as high as possible. But since the attenuation, and increases with frequency, the treatment range is more strictly limited to higher frequencies, the appearance of the present invention allows the use of a higher frequency since the ultrasounds do not need to move. So far away from the tissue as is required with Ultrasounds t ransure to 1 es or ext raborporal. Since a higher frequency can be used, prostate disease is treated with less risk of damaging the critical structures of the patient's anatomy. For the typical distance of 1 cm used by the apparatus of the present invention, 20% of the ultrasound energy should be transmitted to the focal point even at a frequency as high as 10 MHz, while it should be transmitted! 87% at a frequency of L MHz. The typical distance of 4 cm required for transrectal treatment requires that a frequency no greater than 2.5 MHz be used in order that 20% of the emitted ultrasound energy reaches the focal point ., While a lower transmission may be tolerated, a more expensive high power transducer is needed, and as a result the deposition of considerable amounts of heat in the non-diseased tissue that is not intended to be affected. Therefore, the above systems are accommodated using a lower ultrasound frequency than would be desirable for maximum patient safety.

LB In the following two foci of embodiment of a device and a method for t ransurethral therapy are described, as defined by the present invention. The first form of leaLizacion is used with the visual r-ol, Its advantages include the effectiveness, ol low cost, and the lack of trauma, its most preferred use in the treatment of the BPH, although it is also useful. for the treatment of prostate cancer The second embodiment combines therapeutic ultrasound and image formation, allows the position of the focal point inside the tissue to be controlled to less than 1 mm, and allows it to be controlled the effect of omission in real time In addition to the BPH, this embodiment is particularly useful in the treatment of prostate cancer.

FIRST FORM OF PREFERRED EMBODIMENT The first preferred embodiment of a device according to the present invention consists of a therapeutic ultrasound system to which power is supplied by a simple, inexpensive generator. This system is based on visual conti ol and is used without simultaneous ultrasonic imaging. A flexible, flexible package of blood formation / uptake in the catheter miter is included. Referring to Figure 2, the catheter-20 is insert through the patient's 24th port until it reaches the prostatic ur-ethia in the interior of the prostate 110. the probe 29 of the last asons extends further to the catheter '20. the ducts 31, 12 and 33 of The probe is joined in the pack 34 that passes through the interior of the catheter 20. The conduits 31 and 32 carry cooling water between the supply 38 and the probe 9 of ultrasongs. The conduit 30 of the probe carries radio frequency electricity between the power unit 42 and the ultrasonic probe 29. The adapter network 35 minimizes the deficiencies in the coupling of the radio frequency electric power to the transducer. The flexible endoscope 44, which terminates in the eyepiece 46, also passes through the interior of the catheter 20 to provide a view of the prostatic urethra 26 and of the probe 29. The cable 48 carries illumination from the source 50 Luminous to the endoscope 44. The postoperative balloon 51 extends beyond the catheter 20 and is inflated with a fluid from the vessel 54, transported through a tube 52. FIG. 3 shows the housing 55. of transducer of ultrasonic probe 29, which extends from the proximal end 56 of the catheter 20. The conduits 31-33 will fit into the transducer housing. End 58 is far! of the flexible endoscope 44 extends slightly towards the strength of the catheter. The posi- tioning balloon 51 is adjacent to the transducer housing. When the balloon 51 is inflated, the front face 60 of the transducer housing 55 remains 2 (1 pressed iirmomente cent i to la? a? ed 62 of the urethra 26 prest ica, ensuring a good acoustic treatment of the ultrasound energy in the prostatic tissue. FIGURE 4 shows section AA of FIGURE 3"Wall 66 of catheter 20 defines Lumen 68, which houses pack 34, endoscope 44 and tube 52, which is used to inflate the balloon 51. of positioning. Figure 5 shows section BB of Figure 3. The conduit 32 of the probe carries a cooling fluid from the supply 38, which preferably includes a cooler for lowering the temperature of the cooling liquid below the ambient temperature, to the 55th housing of the transducer. The conduit 31 of the probe carries the return liquid from the transducer housing to the supply 38, allowing the continuous flow of flushing fluid. The conduit 33 of the probe provides power to the transducer and can carry other electrical serials. Figure 6A shows the ultrasonic probe 29 according to a further detail. The transducer 72, which includes a single ultrasonic transducer consisting of one or more piezoelectric elements made of piezoelectric material, such as hardened piezoelectric ceramic of zirconate of polymorphism, receives radiofrequency power through conduit 33, and it vibrates in response to the created ultrasound energy. Due to the concavity of the front surface 73 of the '72 transducer, is the ultrasound energy concentrated as shown in the Figure? . The ultrasonic enege is coupled by a quarter-wave plate 74, minimizing reflectance towards the transducer, and passing through the front face of the housing r >5 of the transducer. The transducer and the fourth wave plate are supported by the rear plate 78 and the periphery 00, which defi space 76, which dampens the propagation backwards of the "asleep" FL external housing comprises the face 60 front, the rear face 70 and the periphery (1 of the housing 55 of the transducer.) If necessary 10, the inlet fluid from the conduit 32 enters the housing through the inlet 82, moves through the passage 86, It goes through outlet 84 to duct 31, dragging out the heat generated inside the transducer housing, which could damage the transducer and the quarter-wave plate, and could causing unwanted heating of the urethral wall ls Figures 6B-6D show alternative techniques to achieve * the focus of the ultrasonic energy In Figure 6B, the transducer 72 is flat instead of concave as in the Figure 6A, and the plano-concave lens 73a, of suitable material tr-ansrní sor- of ultrasound, provides focus. In Figure 6C, the transducer 72 is concave but the quarter wave plane is flat, with the space 75 filled with a material that transmits the ultrasound. In Figure bD the transducer comprises a plurality of flat, ring-shaped elements 77. Electric energy is supplied to each ring with a phase that is advanced with respect to the phase of the electric energy supplied to the next inner ring, creating a bundle that concentrates the energy of the two atoms. During use, catheter 20 and probe 29 are advanced to the prosthetic urethra. The endoscope 44 is used to position the probe as desired. When the position is correct, the positioning ball is inflated to fix the position of the probe and to ensure good contact between the front face and the urethra. In this way, blood and other body fluids are excluded from the ar- ea between the transducer and the prosthetic tissue. When the position has been set, energy is applied from the power source 42 to the transducer '72 through the conduit 33 and the network 35 ada t ad a. As illustrated in Figure 7, the ultrasound energy of the transducer '72 passes through the quarter-wave plate 74, the cooling liquid of the passage 86, the front wall 60 of the transducer housing, and the wall 62 uret al, then entering the prosthetic parenchyma 81. The ultrasound energy is absorbed in the prostatic parenchyma, depositing an energy in the form of heat generally proportional to the intensity of the ultrasound. Due to the concentration effect, the external rays 84 converge so that the intensity is greater near the focal plane. When it is refilled, a considerable amount of heat is deposited in the central zone 08 while much less heat is deposited in the other interior parts to the prstate. In the areas above the focal plane, the attenuation and the scattering of Jos ul * i asoiu dos on a larger area ', to cause a more rapid descent of intensity. This has the desired effect of the tendency to not use the fabric beyond the point, including various critical structures.When the temperature of the central zone 88 has cremerated, a generally spherical surrounding volume is heated by Thermal conduction The isotherms 90 define spherical enclosures with a temperature that increases towards their center, the power of the ultrasounds, the frequency and the duration can be chosen so that an exposure to ultrasound between 30 seconds and 10 minutes provokes that a volume of several cubic centimeters is slowed down to a temperature of at least 60 ° C. It is known in the art that the tissue of the prostate heated to this temperature suffers coagulative necrosis and is subsequently reabsorbed. , the apparatus of the present invention causes the elimination of a clinically useful volume of tissue without frequent re-focusing of the ultrasound, and without needing ad of a complex system to produce - and control - the movement of the probe in relation to the tissue. According to a particularly preferred method, the concentration of heat generated in the tissue within the interior zone is further increased. Is it known? Very much the fact that the properties of propag-idon ul Masonic of the tissue are modified with the changes'-, < tissue such as coagulative necrosis., M.L. Bush, r. Rivens, G.R. ter Haai, and 3.C., Ba ber b have reported on the measures of this effect in the? ulo titled "Acoustic properties of injury with an ultiasound therapy systern" appeared in Ultrasoun < J m Medicine and Biol? Gy, Volume 19, Number 9, pages 70 ROI ,. They have found that the attenuation of acoustic waves is increased when the tissue has settled sufficiently for coagulative necrosis. The average increase in the values of its measures was 98%,. In the particularly preferred procedure, the ultrasound was applied with a high intensity intensity for a short time, so that the surface was denatured or left in the center zone. Other zones of the tissue, where the intensity of the ultiasons is lower, have not been heated so much and are not denaturalized. The power of the ultrasound is then lowered, preferably in a short time of 0 about 5 seconds or less to avoid unnecessary losses of heat, to a level where the tissue outside the focus does not warm significantly. . In the central zone 88, due to increased tissue attenuation <It has been denaturalized, continuing to deposit heat in a high proportion. The additional heat is then moved by thermal conduction to the tissue of the area surrounding the focus. In this way a large, objective volume of tissue is tied up without excessive fabric density, which is not the objective, the operator can convert the ultrasonic power after an interval of time. according to some or other criteria. This change «The power is preferably carried out by an automatic system in response to a tempor ad o The detection of some condition with means that are familiar to experts in the field. In one form of monitoring, the echo is "ultrasound is detected by the ultrasound transducer". This is done with sum Jares media to those of the second embodiment described below, but it can be 1e use a simpler system since there is no need to form an image of ultrasounds. In this way, it is necessary to measure the reflection of part or all of the ultrasound used to heat the tissue. The induced changes in the tissue near the focal point cause changes in the reflected asonsides including changes in the readiness, speed of sound, and others. In one embodiment, the change in intensity of the reflected ultrasound is detected. This change indicates that the tissue near the focal point has been denatured. The ultrasonic power is then lowered, either automatically or by the intervention of the oper-ary. It is also possible that the device responds automatically to the detection of a fault condition. For example, one can measure the temperature of the cooling fluid exiting from the L to the transducer with means such as a mop placed in the outlet duct 31. If this is too much, it indicates that the electrical energy supplied to the transducer is not converting effectively into ultrasound energy coupled to the interior of the prostate. The automatic circuit responds to this temperature. a can lower the level of electrical power, avoiding damage to the transducer. Alternatively, as is known in the art, a conventional ultrasonic imaging probe could be placed in the rectum to control the placement of the surgical device and / or the development of the lesion. Since the probe is very small and is supplied by a flexible system, and since the wall is not pierced or excessively heated, the discomfort during the procedure is not worse < That is in the iLexible cytoscopy, which is carried out ru inaria without other anesthesia «tho it is not the topical lidocama. The need for posterior catheterization-to the process is limited by the absence of trauma to the urethral wall, so < A patient without complications or cornorbilities can go home the same day he has been treated.

SECOND FORM OF PREFERRED EMBODIMENT A second preferred embodiment of an apparatus according to the present invention integrates the therapeutic mechanism of a 11-year-old with me, a transient wave of ul 11 training methods of? nag «an, such as < -, e shows in Figure 8. This system e > The invention is generally in the art, but in the apparition of this preferred embodiment of the present invention, it has been directed for use in a small duct such as the urethra. Its dimensions, endotomy and delivery method and endoscopic visualization are sinular to those of the apparatus of Figures 2-6. The power and control unit 92 provides electrical power to excite the L06 transducer for image formation and for therapeutic purposes. All these conducts are contained in the cable 105. The ultrasonic image 95 generates by means of mechanical movement or by means of an electric assembly, being both techniques known in the technique, and is presented in the screen 94. Par-a therapeutic use where Preference is given to a small numerical aperture, power is provided to every oliver- J06. For image formation, which requires a greater depth of field, power is provided only to the central portion 108 of the transducer 106. The combination system provides transurethral ultrasound in real time before, during and after therapy. The therapy can be interrupted briefly to acquire an updated sonogram, allowing the treatment to be monitored. Localization and positioning 20 del pai ato in Injury? a? in < The correctness of the integrity of the implant is precise, since the heating of the tissue to a temperature greater than 60 ° C results in a bright area in the ultrasonography. The symbol 97 internally generated in the ultrasound image specifies the focal point of the transducer-pair-to ultrasound therapy with a precision better than one millimeter. Deb? «Jo near the lesion, the rassuret ral imaging transducer shows the development of the echogenic zone 96 with great clarity. When the probe 106 is positioned "such a way" that the symbol 97 matches the image of the tissue to be treated, it is known that the therapeutic ultrasound is focused precisely on the tissue. The round trip attenuation of the diagnostic ultrasound and the return echo is less than 85 percent, for a frequency of 5 MHz and a distance of L2 m from the probe to the focus. This allows an excellent signal-to-noise ratio. The images of the treated areas can be stored in a memory and displayed even after "} that the immediate echogenicity has vanished. Multiple lesions, focused precisely and controlled in size, can occur in a minimum time. It is also possible to control therapeutic ultrasound therapy using a trans-ultrasonic ultrasound probe. Beyond its use in difficult BPH lesions, this system can offer the first minimally invasive effective system for the treatment of prostate cancer. Local injuries can be targeted for obliteration. Also, it can be heated as much as necessary and the paron < A prostat ico until tompcratuias «coagulation. In the case of a residual or recurrent tumor, the repeated procedure causes minimal morbidity. This system would approximate or surpass the effectiveness of the radical prestige while maintaining continence and sexual function in the majority of cases, due to its low trauma. According to an alternate relational use, the hypertext derived from the heating of the prostate with any of the devices of this invention can be used in combination with ionizing radiation therapy. It is known that the combination of hypertension and ionizing radiation is effective in the treatment of malignant tumors, the tissue temperatures used in this application are lower than those required for eoagulative necrosis., and preferably are less than 50 ° W. Although the invention has been described with particular reference to prostate diseases such as BPH and prostate cancer, there are many other organs, including but not limited to the heart, liver, urinary bladder, gall bladder, and the organs of the circulatory system, <They can be treated by devices within the scope of the invention. The two preferred embodiments of the apparatus of the present invention are illustrative. Other embodiments of the invention, within the scope of the invention, < What is established by the claims < That they continue to be recognized, they will be recognized1-, by experts in the field.,

Claims (22)

NOVELTY OF THE INVENTION CLAIMS

1. - An apparatus for treating frosty prostate of the prostate in the body of a mammal, said device comprising: (a) a generator of a radiofrequency electrical signal, which is a frequency within "JoL mteival? from «Jeode to e« Jedor of 1 MHz up to about LO MHz, capable of generating a constant level of power and capable of operating at said constant power level for a period of time of at least 30 seconds; (b) an ultrasonic probe means including a transducer housing that contlns a transducer with a "trans" unit made with one or more elements of a piezoelectric crystal and an exit opening having an area, and corresponding means of coupling and focusing means thereof, to convert at least a portion of said electrical signal into a beam of ultrasound energy, said beam having an area and a power sufficient to produce thermal effects in the prostatic tissue. and to cause coagulative necrosis in the selected portions of the diseased prostatic tissue, and to couple said ultrasound energy in the prostatic diseased tissue, and to focus said ultrasound energy in a focal plane, thereby < } that the aforementioned area of said ultrasound energy beam in said focal plane be smaller than the area of said aviation; (c) means of interception for transduction on the above-mentioned means of "ultrasound in the prostatic urethra" read the body of a mammal; and (d) positioning means for attaching said probe means to ultrasound in a desired position in said prostatic urethra; (e) at least one means of saturation to allow remote observation of at least one between the position of said ultrasound probe means, and the treatment of said diseased prostatic tissue, said means being selected from visualization of the group (m) consisting of: (i) an endoscopic means for viewing the position of said ultrasound probe means inside the urethra, and (ii) a diagnostic ultrasound means for generating a signal of imaging by ultrasound, to produce an ultrasound image of at least a portion of the prosthetic tissue to be treated.

2. The apparatus according to claim 1, wherein said means of ent r-ega is a tubular shaft housing having a proximal end and a distal end, an internal diameter, an external diameter, a length and at least one lumen extending therethrough, the aforementioned probe means being used for ultrasound with the aforementioned means of meshing and being positioned on said distal end of the aforementioned training medium.

3. The apparition according to claim 1, wherein said means of delivery includes a flexible catheter < Which has a pyoxune end, a distal end, > a longitudinal axis from said proximal end to said distal end, without < The maximum dimension of the catheter in the direction transverse to the aforesaid longitudinal axis is greater than 10 m, the. cited probe means of a second probe with the aforementioned catheter and being positioned in the aforementioned ex-oar «Jistal of dLho catheter.

4. The apparatus according to claim 1, wherein said means of coupling and said method of focusing constitute a pair of elements selected from group (i-iv) consisting of: (i) a concave transducer for focusing , in communication with a concave fourth plate «Je wave for coupling; (ii) a planar transducer with a planoconcave lens made of an ultrasound transmitter material for focusing, in communication with a quarter-wave concave plate for coupling; (n) a concave transducer in collaboration with a planar quarter-wave plate, with a space between both filled with a transmitting material "ultrasound, such that said transducer and said ultrasound transmitter material" said space provide the focus; and said quarter-wave plate provides the coupling; and (iv) a transducer or made of a plurality of flat, ring-shaped elements, which form a phased focusing assembly, and a quarter-wave planar plate for coupling.

5. The item according to claim 4, in which "said means of focus and said means" read coupling are (i).

6.- The apaiato according to the i e? Vm «J? drops i on 1, in the < The fact that the aforesaid energy of assonids is approached with a smaller relative aperture around "Jo 1.7.

7. The apparatus according to claim 1, wherein less than 80% of the emitted ultrasound energy is absorbed before it reaches said diseased prostatic tissue to be treated.

8. The apparatus according to claim J, which also includes cooling means for limiting at least one temperature selected from the group consisting of: (i) at a temperature reached by said sensor and the means "Jo coupling", and (n) the temperature reached by the surrounding prosthetic and non-prostatic tissue, closer to said transducer and to the c? ta < Jo coupling medium.

9. The apparatus according to claim (i), wherein said cooling means includes a source of cooling fluid external to said unit, a means for allowing said cooling liquid to flow in a manner that allows said cooling liquid to flow in such a manner. Continues from said source to the mentioned apparatus and very soon to said means "ultrasound probe, and a means to further allow" the said cooling liquid to flow, after being heated by the absorption of heat- "Jesde the aforementioned ultrasound probe means, towards the outside of said apparatus.

10. The apparatus according to claim I, in the < } The said posi-cientution means includes an inflatable balloon to hold said ultrasound probe means in a selected position in said prosthetic urethra.

11. The apparatus according to claim 1, wherein the ultrasound power output from the "ultrasound probe necessary to produce the neceo1" means! s coagulates * iva, does not exceed 10 wat ios.

12. The apparatus according to claim 1, in which when selecting said diagnostic ultrasound means, the total attenuation of said serial of ultrasound image formation and the return echo of the same does not exceed 90 percent.

13. The unit according to the embodiment 1, wherein said generator of the radio frequency electric signal includes a means to vary the power during the treatment according to a previously programmed regime.

14. The apparatus according to claim 1, wherein said generator of the radio frequency electric signal includes a pair means "to detect a fault condition and automatically reduce the power driven to said transducer- in response to the detection of the fault condition.

15.- The apparatus «Je agreement with claim i, 'ib «| Which also includes a var lador medium« Je-? ? ntens? "Jad to modify the intensity" of the energy of a person from a predetermined first level to a second predetermined level, low, within a term that does not exceed 5 levels. .

16.- F apa a or according to claim 15, in which said means "intensity" includes a means to vary the intensity of assorted ultons automatically in a preselected time interval after d? that irradiation with ultrasound energy has begun.

17. The apparatus according to claim 1, further including a means for detecting the echo return of the ultrasound from the tissue in the vicinity of the focal point. The ultrasonic energy.

18. The apparition according to claim 17, wherein "at least one characteristic of said echo" is the return of the ultrasound is used to define a point in the time in which to modify. intensity of the ultrasound energy from a predetermined first level to a second predetermined level.

19.- A procedure. for the treatment of diseases in a mammal, said method comprising: "a selected portion of the diseased tissue in the body of the vessel with ultrasound energy" which has a frequency comprised in the range; Je 1-10 MHz, using a device < which comprises: (a) a generator of an electrical signal} ? radio recuence, < What is the degree of coverage included in the interval from 1 MHz to about 1 MHz, capable of general a constant level of power? and capable < To operate at that constant level "The power for a period" of at least 30 seconds; (b) an ultrasonic probe means that includes a single transducer with one or more piezoelectric sensors and an exit opening < μ.? e possesses a product, and a co-responding coupling medium and means < And the approach itself, to convert at least a portion of said electrical signal into a beam of ultrasound energy, said beam having a sufficient area and power to produce thermal effects in the prosthetic tissue and for to cause coagulative necrosis in the selected portions of the diseased prostatic tissue, and to attach the said energy to ultrasound in the diseased prosthetic tissue, and to focus said ultrasound energy in a local plane such that the area of said beam of ultrasound energy in the said focal plane is smaller than the mentioned area of the aperture mentions; (< :) means of delivery to introduce transurethrally into the body of a ultrasound probe in the prostatic urethra of a mammalian body, and (d) positioning means to fix the cited medium of? they are "ultrasound" in a position of "that of the aforementioned prostatic urethra; fe) at least one display means for allowing remote observation of at least one between the posi tioning of the said ultrasonic probe means, and the treatment of this tissue prest tico e foimo, .. Otando selected the aforementioned means "would visualize" He L group (111) consisting of: (i) an ondoscopic medium to see the position "Je said medium" Je probe from ul < rasoni «Jos inside the urethra, and (??) a means« ultrasound of diagnosis to generate- a signal of image formation by ultrasound, pair-to produce an image of ultrasound of the wheels a portion dl tissue prost T ico to be treated, such that said ultrasound energy is coupled in the aforementioned tissue an * cause the «Jeposicion of heat near a focal point inside the aforementioned mammal's body; The intensity of the aforementioned ultrasound energy is initially high enough to cause the denaturing and change of the ultrasound attenuation properties in a small area of said diseased tissue near the said local point, in a time < It should be short enough to avoid coagulative necrosis in the non-diseased areas of the tissue surrounding said diseased tissue, and the aforementioned intensity of said ultrasound energy is then lowered so that the deposition occurs. It is preferable in the small area of diseased tissue where the attenuation properties have been changed.

20 »- A procedure« Treatment of cancer «The prostate that includes: using energy« Ultrasound to place the prosthetic tissue in rotation and produce effects h? In the same way, the aforementioned energy supply is provided by me or by an aparate; «| Which compiles« Je: () a generator of an electric signal «Je i adiof rec:? Enc? A,«? Ut > Does it have a frequency in the range "from around" to L MHz up to about 10 MHz, capable of generating a constant power level capable of operating at that constant level? of power for a period of time of at least 30 seconds; (b) a probe means of ult rassons < What does a single transaction include? with one or more piezoelectric elements and an exit opening < ? uo has an area, and a means < The corresponding coupling and focusing means will be used to convert at least a portion of said electrical signal into a power source of ultrasound, having dLch? Make a sufficient strength and ar- row to produce thermal effects in the prostatic tissue and to cause coagula necrosis. * The selected portions of the diseased prosthetic tissue, and couple, to couple the aforementioned tissue energy into the tissue. ill prosthetics, and focus said ultonal energy in a focal plane such that the said area of said energy beam of ult i sounds in the said focal plane is smaller < } that the area cited «Je The aforementioned opening; (c) Entity means for? nt ro < luc? r < The aforementioned ultrasound probe means in the urethra of the body of a mammal, and (< J) positioning means for attaching said means to the ultrasound probe in a desired position in said urethra 41) prostat ica; (e) at least one means and one view to allow remote observation of at least one between the position of said ultrasound probe means, and the treatment of said prostate tissue with the patient selected. The aforementioned means of visualization of the group (iii) consists of: (i) an endo-ocular medium to see the position of said means "the ultrasound probe inside" the urethra, and (ii) a means of diagnostic ultrasound to generate an imaging signal by ul t rasom «Jos, to produce an ultrasound image of at least a portion of the prostatic tissue to be treated; and applying ionizing radiation therapy to said prostatic tumor tissue in a selected manner from the group (lii-iv) consisting of: (iii) prior to the application of said aforementioned energy of ultons, and (iv) in a manner snnultile to the application of the mentioned ultrasonic energy.

21. The apparatus according to claim 1, further characterized by irradiating a selected portion of? diseased tissue in a body of a mammal with energy «Je ultrasound that has a frequency on the scale of 1-10 MHz; said ultrasound energy being coupled to said diseased tissue to produce heat deposition near a focal point in the interior of said mammalian body; the intensity of said ultrasound energy being initially sufficiently high to produce denaturation and change in the properties of the ultrasound attenuation in a small region of said stubborn tissue of the focal point, "Jentro" at a time. It is scientifically short to prevent coagulative necrosis in very diseased regions. and said intensity of ultrasound energy being "Jespues reduced from? way «? that the deposition In this heat, preference occurs in said small region of the diseased tissue in which the ultrasound attenuation properties have been changed.

22. The apparatus according to claim 1, further characterized by the use of ultrasound energy to heat a prostatic tissue and produce super-thermal effects thereon; and applying therapy to the aforementioned tuinoral prosthetic tissue in a selected mode of the group (m-iv) consisting of: (m) before applying said ultrasound energy, and (iv) simultaneous with the application of said ultrasound energy.