WO2008132735A1

WO2008132735A1 - A urethral implant and method

Info

Publication number: WO2008132735A1
Application number: PCT/IL2008/000559
Authority: WO
Inventors: Hamid Sharim; Shmuel Beck
Original assignee: Mediflow Medical Solutions Ltd.
Priority date: 2007-04-25
Filing date: 2008-04-27
Publication date: 2008-11-06

Abstract

There is provided an implant (300) for use in the treatment, amelioration and/or prevention of urethral stenosis. The implant is adapted to be inserted into a urethra, particularly into at least a portion of the prostatic part of the urethra (the part of the urethra which passes through the prostate), and apply pressure, for example, peripheral pressure, against the prostate, while allowing urine flow. The pressure applied by the implant against the prostate 'pushes' the part that is in direct contact with and/or in proximity to the implant, away from the prostatic part of the urethra.

Description

A URETHRAL IMPLANT AND METHOD

FIELD OF THE INVENTION

The invention relates to methods and apparatus for facilitating urination.

BACKGROUND OF THE INVENTION

The male urethra is a tube which connects the urinary bladder to the outside of the body. The male urethra passes urine and sperm to the outside. In the human male, the urethra is typically about 20 cm long and opens at the end of the penis. The urethra is divided into three parts in men, named after their location:

The prostatic urethra, the widest and most dilatable part of the canal, is about 3 cm (centimeter) long. It runs almost vertically through the prostate from its base to its apex, lying nearer its anterior than its posterior surface; the form of the canal is spindle- shaped, being wider in the middle than at either extremity, and narrowest below, where it joins the membranous portion.

The membranous part of the urethra (the intermediate part of the urethra) is the shortest, least dilatable, and, with the exception of the external orifice, the narrowest part of the canal.

The penile urethra (cavernous portion of urethra, spongy urethra) runs along the length of the penis and is the longest part of the urethra (about 15 cm long) and extends from the termination of the membranous portion to the external urethral orifice.

The prostate is a compound tubuloalveolar exocrine gland of the male mammalian reproductive system. The main function of the prostate is to store and secrete a clear, slightly alkaline (basic) fluid that constitutes up to one-third of the volume of semen. In a healthy man the prostate is slightly larger than a walnut. It surrounds the urethra just below the urinary bladder and can be felt during a rectal exam. Thus, in a healthy man, urination is not interrupted by the prostate. Prostate related disorders, however, offten affect the urethra, for example, by applying pressure on the urethra which causes a urithral stenosis and as a result inhibit or even prevent urination.

Among the common prostate related conditions and/or disorders that may cause urethral stenosis are the following:

Prostatitis - an inflammation of the prostate gland. The inflammation is often accompanied with swelling of the prostate and as a result an increased pressure is applied to the urethra resulting in inhibition of urination. There are different forms of prostatitis, each with different causes, outcomes and treatments. Acute prostatitis and chronic bacterial prostatitis are generally treated with antibiotics; chronic non-bacterial prostatitis or male chronic pelvic pain syndrome, which comprises about 95% of prostatitis diagnoses, is generally treated by a large variety of modalities including phytotherapy, alpha blockers, physical therapy, trigger point therapy, psychotherapy, antihistamines, anxiolytics, nerve modulators and more. The medications have only limited success rates and in order to achieve any noticable effect, for example, pressure relief from the urethra and thus improved urin flow, a long and tedious treatment is required.Benign prostatic hyperplasia (BPH) - generally occurs in older men. The prostate often enlarges to the point where urination becomes difficult. If the prostate grows too large it may constrict the urethra and impede the flow of urine, making urination difficult and painful and in extreme cases completely impossible. BPH is currently being treated with medication (having, as mentioned above, a limited success and require a lengthy treatment) or with surgery that removes part of the prostate that is pressing against the upper part of the urethra and restricting the flow of urine. Surgeries include open surgeries and transurethral resection of the prostate (TURP or TUR). In TURP, an instrument is inserted through the urethra to remove prostate tissue that is pressing against the urethra and restricting the flow of urine. These surgeries, IL2008/000559

particularly open surgeries, require a lengthy recovery time of the patient and may induce multiple complications such as infections.

Prostate cancer — among the most common cancer types elderly men in developed countries and a major cause of death. Prostate cancer can be treated with surgery, radiation therapy, hormone therapy, occasionally chemotherapy, proton therapy, or some combination of these. Since prostate cancer is a disease of older men, many will die of other causes before a slowly advancing prostate cancer can spread or cause symptoms. Therefore, in many cases due to the complexity, the complications and the side effects of the common treatments, the doctors often make a decision not to treat localized prostate cancer (a tumor that is contained within the prostate). Among the various consequences of such decision remains the urination problem that dramatically affects quality of life.

US Patent 5588965 to Burton discloses a device for dilating an obstructed portion of the urethra by positioning a pressure source within the bladder in fluid communication with the inflatable dilation balloon. The pressure source, which is also used as a positioning balloon within the bladder sequentially contracts under pressure and causes the inflatable dilation balloon to dilate thereby somewhat relieving the obstruction in the urethra. However, this device is merely capable of temporarily widening the narrowed urethra due to the low pressures provided by the device. The device functions as a catheter, and the patient is not in control of his urine flow.

There is thus a need in the art for new and improved apparatus and methods for efficiently widening a stenotic urethra in the prostatic region and facilitating urination with minimal invasiveness, complications, side effects and healing time.

There is also a long felt unmet need for a device for dilating a stenotic urethra with lumens that do not protrude from the penis and disturb the patient. The term "stenosis" refers to an abnormal narrowing in a blood vessel or other tubular organ or structure, such as but not limited to, a urethra.

More information about the structure, function, disorders and treatments related to the male urinary system and prostate may be found at http://www.chronicprostatitis.com/meds.html, http://en.wikipedia.org/wiki/Prostate#_note-cpcom, http://en.wikipedia.org/wiki/Prostate_cancer and http://en.wikipedia.org/wiki/Urinary_system, which are incorporated herein by reference in their entirety.

SUMMARY OF THE INVENTION

An aspect of some embodiments of the invention relates to improving urine flow in a male.

An aspect of some embodiments of the invention relates to reducing the pressure applied by the prostate against a urethra.

An aspect of some embodiments of the invention relates to re-shaping a part of the prostate, which surrounds the urethra.

An aspect of some embodiments of the invention relates to reducing the pressure applied by the prostate against the urethra and thus to ameliorate stenosis of the urethra particularly in cases wherein the urethral stenosis is at least partially caused by an increased prostate pressure.

According to an aspect of some embodiment of the invention, the reduction of pressure applied by the prostate against the urethra improves urine flow. An aspect of some embodiments of the invention relates to providing an implant for use in the treatment, amelioration and/or prevention of urethral stenosis. The implant is adapted to be inserted into a urethra, particularly into at least a portion of the prostatic part of the urethra (the part of the urethra which passes through the prostate), and apply pressure, for example, peripheral pressure, against the prostate, while allowing urine flow. The pressure applied by the implant against the prostate "pushes" the part that is in direct contact with and/or in proximity to the implant, away from the prostatic part of the urethra.

According to an aspect of some embodiment of the invention, the pressure applied by the implant against the prostate induces the formation of a scar tissue and/or connective tissue, such as fibrous connective tissue (fibrosis), in a part of the prostate which is in direct contact with and/or in proximity to the implant. The scar tissue and/or connective tissue in the prostate area surrounding the urethra substantially assumes a shape determined by the shape of implant.

According to an aspect of some embodiment of the invention, the implant is a temporary implant. The implant may be removed from the urethra after a certain period of time, for example, upon achieving a certain result, such as sufficient stabilization of the scar tissue and/or connective tissue in the prostate in a shape that would allow, upon removal of the implant, a substantially uninterrupted urine flow through the prostatic part of the urethra.

In an embodiment of the invention, the implant may include a tube and an expandable element, such as a balloon, adapted to be inserted into a prostatic part of the urethra and to be expanded (for example inflated with fluid) after insertion. The expanded element (for example an inflated balloon) is adapted to assume a shape that would apply pressure (for example, peripheral pressure) against the prostate and induces the formation of a scar tissue and/or connective tissue, such as fibrous connective tissue (fibrosis), in a part of the prostate which is in direct contact with and/or in proximity to the implant. After a certain period of time the scar tissue and/or connective tissue in the prostate area surrounding the urethra substantially assumes a shape determined by the shape of implant. At this time or after any other period of time, such as upon achieving a desired medical result (for example, formation of a scar and/or connective tissue), the expanded element may be reduced (for example, the fluid may be extracted from a balloon) and optionally, the implant may be removed from the urethra. After the removal of the implant the scar tissue and/or connective tissue formed in the prostate area surrounding the urethra substantially maintain its acquired shape (induced by the expanded implant) and thus prevents the prostate from applying pressure and narrowing the urethra.

Hence, a major core principle of the invention is herein disclosed; the lumens and tubes which communicate between balloons or expandable or inflatable members are all highly stretchable and elongatable and variable in length. When not in use for inflating or deflating the aforementioned balloons or inflatable members, they may be accommodated within the penis in their relaxed state or conformation, and .the distal ends may be pulled out of the penis end for coupling to a pressurized fluid supply when this is required.

According to an aspect of some embodiments of the invention, the implant, for example, the implant's surface, may include a medicament, diagnostic agents and/or nutrient(s) adapted to treat, ameliorate and/or prevent a prostate and/or urethral related condition or disorder. Such substances may include NSAIDs (Non-Steroidal Antiinflammatory Drugs), steroid agents, antibiotics, chemotherapeutics, radio-therapeutics, antiviral drugs, a diagnostic agent or any other medicine and/or diagnostic agent. The substances may be adapted for immediate release or sustained release, for example, embedded within a matrix, such as a polymeric matrix.

In another embodiment of the invention, the implant may at least partially undergo degradation or dissolve in the body. Optionally, the implant may further be held and/or stabilized and/or anchored within the urethra to minimize undesired migration, for example, by a balloon that is adapted to be located in the bladder and upon inflation with fluid to hold and stabilize the implant.

According to an aspect of some embodiments the invention, there is provided a method of improving urine flow, the method includes inserting an implant which includes an expandable element (such as a balloon and/or extending arms and/or wings) in a male urethra. The method may further include shaping and/or inflating the expandable element, for example by inserting fluid to a balloon in the implant. The method may further include shaping, expanding and/or inflating the implant, for example, in order to apply pressure against the prostate and/or to induce the formation of a scar tissue and/or connective tissue in the prostate area, which surrounds the implant. The method may further include reducing and/or deflating the implant, for example, by extracting the fluid from the implant after a certain period of time. The method may further include removing the implant from the urethra reducing and/or deflating the implant, for example, by extracting the fluid from the implant after a certain period of time. After the removal of the implant the scar tissue and/or connective tissue formed in the prostate area surrounding the urethra substantially maintain its acquired shape (induced by the expanded implant) and thus prevents the prostate from applying pressure and narrowing the urethra.

According to an aspect of some embodiments the invention, the procedure of inserting the implant to the urethra may be performed under local or general anesthesia According to an aspect of some embodiments the invention, the procedure may be performed either in a hospital or a medical facility and even at a doctors clinic.

In an embodiment of the tube of the implant, may include a rigid or flexible material like rigid plastic that is commonly used, and/or a silicone tube. The expandable element of the implant, such as the balloon, may include a silicone shell. The balloon may be inflated with a gel-like material, such as silicone gel. The balloon may be inflated with fluid, which may include a low viscosity fluid, such as water, saline, air or any other appropriate fluid.

BRIEF DESCRIPTION OF FIGURES

Examples illustrative of embodiments of the invention are described below with reference to figures attached hereto. In the figures, identical structures, elements or parts that appear in more than one figure are generally labeled with a same numeral in all the figures in which they appear. Dimensions of components and features shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. The figures are listed below.

Fig. 1 schematically shows a partial view of a male anatomy and a urethral path;

Fig. 2 schematically shows a partial view of a male urethral path;

Figs. 3 A schematically shows a longitudinal cross section of a deflated implant, in accordance with an embodiment of the invention;

Figs. 3B schematically shows a cross section of the deflated implant of Fig. 3 A, taken along the line a-a, in accordance with an embodiment of the invention;

Figs. 3 C schematically shows a longitudinal cross section of an inflated implant, in accordance with an embodiment of the invention;

Figs. 3D schematically shows a cross section of the inflated implant of Fig. 3 C, taken along the line b-b, in accordance with an embodiment of the invention;

Fig. 4 schematically shows a longitudinal cross section of an implant, in accordance with another embodiment of the invention;

Fig. 5 schematically shows a longitudinal cross section of a urethra, receiving an implant, in accordance with an embodiment of the invention; and Fig. 6 schematically shows optional implants (longitudinal cross section), in accordance with embodiments of the invention.

Fig. 7 schematically shows a side view of a preferred embodiment of the invention.

Fig 8 schematically shows an isometric view of a preferred embodiment of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

US Patent 5588965 to Burton discloses a device for dilating an obstructed portion of the urethra by positioning a pressure source within the bladder in fluid communication with the inflatable dilation balloon. The pressure source, which is also used as a positioning balloon within the bladder sequentially contracts under pressure and causes the inflatable dilation balloon to dilate thereby somewhat relieving the obstruction in the urethra. However, this device is merely capable of temporarily widening the narrowed urethra due to the low pressures provided by the device. The device functions as a catheter, and the patient is not in control of his urine flow. The balloons are all connected, limiting independent operation of each.

It is a purpose of the invention that the device herein provided is comfortable for the patient and that he is in control of his urination as much as possible, and that the penis will be as unencumbered as possible. Hence, it is a major core principle of the invention that the lumens and tubes which communicate between balloons or inflatable members are all highly stretchable and elongatable and variable in length so that they may be accommodated within the penis when not in use for inflating or deflating the aforementioned balloons or inflatable members. Furthermore, even when the aforementioned lumens and tubes are fully stretched and or elongated, they are adapted to maintain a bore sufficiently wide as to enable the inflation or deflation of the said balloons and inflatable members. In other words, the bores of any of the stretchable lumens, though they may vary in diameter between the relaxed unstretched state and the stretched elongated state, is at all times sufficiently wide as to allow fluid communication. It is herein acknowledged that a particularly suitable material for use in the preferred embodiments of the invention is medical grade LSR silicon rubber with an elongation of about 400%. Hereinafter the terms "stretchable" , and "elongatable" are used interchangeably .Hereinafter the terms "lumen" may refer to the space within a tube, or the tube itself.

The present invention discloses a device and method which exerts a high pressure (between about 0.5 ATM to about 2.0 ATM) in the stenotic portion of a urethra which has been narrowed due to hypertrophy of the prostate gland. The present device and method provides surprisingly high pressure exerted against the prostate, which induces necrosis and scar tissue formation in the surrounding connecting tissue and deep into the glandular prostatic tissue. The protracted high pressure exerted by the device causes the gradual formation of substantially deep necrosis of the surrounding tissue, thereby opening the formerly restricted pathway. Previous prior art methods using acutely applied high pressure have failed because the extreme pain caused was intolerable to the patients. The invented method and device is specifically adapted to allow the pressure in the stenotic urethra to be increased gradually in step-wise increments. At least three elements, each of which can, in some preferred embodiments, be independently expandable elements such as balloons, are used. The balloon responsible for expanding the within the prostatic region of the urethra is filled with fluid under high pressure, independent of the pressure filling the bladder anchoring balloon or the urethral anchoring element or balloon. The pathway thus formed is wide and permanent because of the profound depth of the necrosis formed in the prostatic area. The prostate area through which the urethra passes, is thereby permanently fixed in an expanded shape, restoring normal urinary function to the patient. The method of dilating a stenotic. male urethra herein disclosed comprises steps of inserting the device under a local anesthetic. Fluid is injected to inflate each of the balloons schematically illustrated in figs.3, 4, 5, 6, 7, and 8. The adjustable distal bladder anchoring means balloon (730), an adjustable proximal anchoring means balloon (710) are injected to the predetermined pressure necessary for their respective anchoring functions. The radially adjustable urethral dilating balloon (720) is injected with the predetermined high pressure necessary for the urethral dilating and necrotic process to begin. Since, in contrast to prior art, the aforementioned balloons are fluidly connected each to its own lumen, each fluid injections is, in preferred disclosures of the method, seperately performed. In some preferred methods, the pressure is maintained for about one week, and then released. The pressurizing fluid injections are repeated one, two or more times with increasing pressure for the duration of the treatment. It is acknowledged herein that the aforesaid method may have many predetermined physician controlled variations according to the depth of necrosis achieved and the gradually widening of the initially stenotic urethra.

A partial view of a male anatomy 100 is schematically illustrated in Fig. 1. The urethra 102 extends from the bladder 104 to the external urethral orifice 106. The urethra 102 extending from the bladder 104, passes through the prostate gland 108 and through the penis 110 and allows urination. Also schematically depicted are the testicles 112 and the rectum 114.

A more detailed view of the urethral path 220 is schematically illustrated in Fig. 2. The urethra 222 extends from the bladder 224 to the external urethral orifice 226 of the penis 228. The urethra 222 is divided into three main parts: the prostatic part 230, the membranous part 232 and the penile part 234. The prostatic part 230 of the urethra 222 extends from the bladder 224 through the prostate 236 to the membranous part 232 of the urethra 222. The prostatic part 230 of the urethra 222 is the widest and most dilatable part of the urethra 222 (typically about 3 cm long). The form of the prostatic part 230 of the urethra 222 is spindle-shaped, being wider in the middle than at either extremity, and narrowest below, where it joins membranous part 232 of the urethra 222.

The membranous part 232 of the urethra 222, is the shortest and the least dilatable and, with the exception of the external orifice 226, the narrowest part of the part of the urethra 222. The membranous part 232 of the urethra 222 extends between the prostatic part 230 and the penile part 234 of the urethra 222.

The penile part 234 of the urethra 222 being the longest part of the urethra (typically about 15 cm long) runs along the length of the penis 228 and and extends from the termination of the membranous part 232 of the urethra 222 to the external urethral orifice 226.

Figs. 3A schematically shows a longitudinal cross section of a deflated implant, in accordance with an embodiment of the invention. Implant 300 includes a urine tube 302 adapted to allow urine flow while the implant is in the urethra. Implant 300 further includes an expandable element; in this case a (deflated) balloon 304 and an inflation tube 306. Figs. 3B schematically shows a cross section of the deflated implant 300 of Fig. 3 A, taken along the line a-a, in accordance with an embodiment of the invention. Implant 300, as shown in Fig. 3 C represents the same implant (or any other implant) in an expanded configuration, in this case, in an inflated configuration. Implant 300 as described in Fig. C, in accordance with embodiments of the invention, includes the tube 302 and an expanded element, in this case an inflated balloon 304', and the inflation tube 306. Figs. 3D schematically show a cross section of the inflated implant of Fig. 3C, taken along the line b-b, in accordance with an embodiment of the invention. In function, the implant 300 is adapted to be inserted into the urethra, particularly to the prostatic part of the urethra, when the expandable element is in a reduced form, such as the deflated balloon 304. After placement of the implant in the appropriate position within the urethra, the expandable element, such as the deflated balloon 304, is being expanded, for example inflated, resulting in an inflated balloon 304'. The expandable element, such as the inflated balloon 304', applies pressure against the prostate and induces the formation of a scar tissue and/or connective tissue, which "fixes" the prostate area through which the urethra passes, in an expanded shape. The inflation of the deflated balloon 304, can be performed by inserting fluid (such as water, saline, a polymeric compound, such as silicone, air, or any other appropriate fluid or any combination of fluids) to the deflated balloon 304, for example through inflation tube 306. The deflated balloon 304 may be filled until a desired pressure is applied to the prostate. At any point of time, while the implant 300 is positioned within the urethra, additional fluid may be inserted into the balloon, which may be in a deflated form (such as deflated balloon 304) or in an inflated form (such as inflated balloon 304'). In addition, at any point of time, while the implant 300 is positioned within the urethra, fluid (for example excess of fluid) may be extracted from the balloon (such as the inflated balloon 304'). It is important to note that, in contrast to the prior art, each balloon is independently attached and communicates with, it's own independent lumen. Thus each balloon may be adjusted and controlled separately.

Reference is now made to Fig. 4 schematically shows a longitudinal cross section of an implant, in accordance with another embodiment of the invention. Implant 400 includes a urine tube 402 adapted to allow urine flow while the implant is in the urethra. Implant 400 further includes an expandable element; in this case a balloon 404 (balloon 404 is shown here in a deflated form but may also be in an inflated form, as shown in dotted line 404') and an inflation tube 406. In addition, implant 400 includes a stopper 408, which is adapted to be located in the bladder and, in its inflated form (inflated stopper 408' - dotted line), to stabilize the implant 400 in its location within the urethra and prevent it from sliding out. The stopper 408 is a flexible member, for example, as shown here, a balloon, that is capable of maintaining fluid. The fluid may be filled in the stopper 408 by a secondary inflation tube 410, which is connected on one end to the balloon 404 and on the other end to the stopper 408. The balloon 404 may be comprised of the same or different material(s) as the stopper 408. The material(s) may include silicon, rubber, plastic (or any other polymer) or any combination thereof. The balloon 404 may have the same flexibility or may be less flexible than the stopper 408. In function, the implant 400 is adapted to be inserted into the urethra, particularly to the prostatic part of the urethra, when the expandable element is in a reduced form, such as a deflated balloon 404 and when the stopper 408 is in reduced form. As mentioned above, the stopper 408 is adapted to be located in the bladder. After placement of the implant in the appropriate position within the urethra, the expandable element, such as the deflated balloon 404, is being expanded, for example inflated, resulting in an inflated balloon 404 (as shown in dotted line 404')- The expandable element, such as the inflated balloon 404', is adapted to apply pressure against the prostate and induces the formation of a scar tissue and/or connective tissue, which "fixes" the prostate area through which the urethra passes, in an expanded shape. The inflation of the balloon 404 can be performed by inserting fluid (such as water, saline, a polymeric compound, such as silicone, air, or any other appropriate fluid or any combination of fluids) to the balloon 404, for example through inflation tube 406. The balloon 404 may be filled until a desired pressure is applied to the prostate. Upon inflation of the balloon 404, fluid may pass through the secondary inflation tube 410 to the stopper 408 resulting in an inflated stopper 408' (dotted line). The inflated stopper 408', when located in the bladder may prevent the implant from migrating within the urethra and/or from sliding out.

The stopper 408 may also serve as a pressure relief unit. When the balloon 404 is being filled with fluid and its internal pressure increases above a desired value, the fluid flows through the secondary inflation tube 410 to the stopper 408 and the pressure in balloon 404 is relieved.

In another embodiment, fluid can be filled in the stopper 408 through a separate tube (not shown), which is not directly connected to the balloon 404. At any point of time, while the implant 400 is positioned within the urethra, additional fluid may be inserted into the balloon, which may be in a deflated form (such as deflated balloon 404) or in an inflated form (such as inflated balloon 404'). In addition, at any point of time, while the implant 400 is positioned within the urethra, fluid may be extracted from the balloon (such as the inflated balloon 404').

It is noted that the term "inflated balloon" may include any degree of inflation, partially inflated through fully inflated. The addition and extraction of fluid to and from the implant (such as implant 300 and/or implant 400) may be performed in order to accomplish the desired degree of pressure against the prostate. The degree of expansion of the implant (such as the amount of fluid within the inflated balloon 304' and/or inflated balloon 404' of implant 300 and/or 400, respectively) may vary in time and/or depending on the condition of the subject undergoing the implantation. The implant may be expanded gradually (within a period of minutes, hours, days or even weeks) to induce the desired effect on the prostate.

After a period of time, such as 1-12 weeks or more particularly 6-8 weeks, the implant (such as implant 300 and/or 400) can be removed from the urethra. The temporary implant may also be removed from the urethra after a certain result (such as sufficient broadening of the urethral path within the prostate and/or fixation and/or stabilization of a connective tissue within the prostate that may allow substantially uninterrupted urine flow within the prostatic part of the urethra upon removal of the implant) was obtained or whenever the physician finds it appropriate.

Reference is now made to Fig. 5, which schematically shows a longitudinal cross section of a urethra, receiving an implant, in accordance with an embodiment of the invention. The urethral path 500 extends from the bladder 512 to the external urethral orifice 514. An implant 501 is located within the part of the urethral path 500 that passes through the prostate 503 (as described above, the part of the urethra that passes through the prostate is also called the prostatic part of the urethra). According to some embodiments, the implant 501 may be similar to implant 400 described herein, therefore the discription provided to implant 400 mat apply to implant 500. The implant 501 includes a tube 502 located along the length of the implant 501 and is adapted to allow urine flow from the bladder to the external urethral orifice 514. Implant 500 further includes an expandable element; in this case a balloon 504 (balloon 504 is shown here in an inflated form) and inflation tube 506. In addition, implant 500 includes a stopper 508, which is located in the bladder 512 and, in its inflated form is adapted to stabilize the implant 500 in its location within the urethra and prevent it from sliding out. The expandable element, such as the inflated balloon 504, is adapted to apply pressure against the prostate 503 and induces the formation of a scar tissue and/or connective tissue 516, which "fixes" the prostate area through which the urethra passes, in an expanded shape. The inflation of the balloon 504 can be performed by inserting fluid (such as water, saline, a polymeric compound, such as silicone, air, or any other appropriate fluid or any combination of fluids) to the balloon 504, for example through inflation tube 506. The balloon 504 may be filled until a desired pressure is applied to the prostate. Upon inflation of the balloon 504, fluid may pass through the secondary inflation tube 510 to the stopper 508. The inflated stopper 508, when located in the bladder 512 may prevent the implant from migrating within the urethral path 500 and/or from sliding out.

The stopper 508 may also serve as a pressure relief unit. When the balloon 504 is being filled with fluid and its internal pressure increases above a desired value, the fluid flows through the secondary inflation tube 510 to the stopper 508 and the pressure in balloon 504 is relieved.

In another embodiment, fluid can be filled in the stopper 508 through a separate tube (not shown), which is not directly connected to the balloon 504.

At any point of time, while the implant 500 is positioned within the urethra, additional fluid may be inserted into the balloon 504. In addition, at any point of time, while the implant 500 is positioned within the urethral path 500, fluid may be extracted from the balloon 504 to relief the pressure or to remove the implant.

After a period of time, such as 1-12 weeks or more particularly 6-8 weeks, the implant 500 can be removed from the urethra. The implant 500 may also be removed from the urethra after a certain result (such as sufficient broadening of the urethral path within the prostate and/or fixation and/or stabilization of a connective tissue 516 within the prostate that may allow substantially uninterrupted urine flow within the prostatic part of the urethra upon removal of the implant) was obtained or whenever the physician finds it appropriate. In order to remove implant 500 fluid should be extracted from the balloon 504 and from the stopper 508.

Figs. 6 and 7 show different aspects of balloon type implants 600 and 700 respectively, in accordance with an embodiment of the invention. It is herein acknowledged that the balloons may be of various shapes, and other functionally analogous members may be used in some embodiments of the invention instead of balloons. Implants 600 and 700 include urine tubes 602 and 702 respectively adapted to allow urine flow while the implant is in the urethra. Implants 600 and 700 further comprise expandable elements; in this case inflated balloons 604,704, 605,705 and606,

706 and their corresponding inflation tubes 607 and 707 respectively. Note that 607 and

707 only show one tube or lumen, but of course each inflatable member or balloon has its own lumen. In addition, implants 600 and 700 respectively may include stoppers (not shown).

Reference is now made to fig. 6 presenting a side view of a preferred embodiment of the device for dilating a stenotic urethra. The device comprises the following elements: A flexible urinary catheter (602), an adjustable distal bladder anchoring means (704), an adjustable proximal anchoring means (606) and a radially adjustable urethral dilating balloon (605). Each of the aforementioned is fluidly connected via its own flexible inflating / deflating lumen with the proximal portion of the urethra. In a preferred embodiment of the invention the lumens are so designed as to be elongateable by a few hundred percent from their original length, and are still able to inflate and deflate the balloons. This feature allows inflation, deflation and the maintenance and adjustment of the balloons to be carried out via the lumen lengths using tubes that extend from the penis. When the process of inflation and /or deflation has been concluded the lumen tubes can be released to be re-accomodated within the penis, thereby not disturbing the patient. For example, in some embodiments of the invention the relaxed unstretched lumens or tubes are about 5 cms to about 10 cms. in length. They can be stretched or elongated to about two to three times their length whilst still maintaining a bore sufficient for injecting and/or withdrawing fluid. Some embodiments of the invention are provided with lumens which are stretchable to a maximum of about 10 cms.to 15 cms, and other embodiments have lumens with a maximum stretchable length of about 20 cms. In any case, the lumens are designed to stretch such that their respective taps or ports are exterior to the penis head for ease of access during fluid filling, inflating, and deflating. The aforementioned stretchable and elongatable lumens are proximally terminated with inflating and deflating flexible fluid taps or ports (708) of fig 7). The taps or ports are accommodated within the urethral meatus (bulbous urethra). The taps or ports can be withdrawn by the physician, using a standard instrument and coupled to a pressurized fluid supply or a fluid pump. Some preferred embodiments of the device include tapes or strings or the like attached to the proximal ends of the lumens accommodated within the urethral meatus which can be easily manually withdrawn by the physician or patient when required. Some preferred embodiments of the device include at least one lumen enclosed within a flexible lumen sheath (Fig 8, 801) for preserving the integrity of the lumen arrangement.

Fig. 8 also schematically illustrates the ports or taps of the stretchable elongatable inflating and deflating lumens or tubes which are connected to their respective adjustable distal bladder anchoring means, adjustable proximal anchoring means and radially adjustable urethral dilating balloon. Like the aforementioned lumens, the sheath is stretchable, elongatable and variable in length in some embodiments. Locations for reversibly providing abutments for an insertion instrument can be accommodated within the flexible lumen sheath.

Reference is now made to an embodiment of the invention provided with the aforementioned dilating means tap is adapted to be reversibly coupled to an external fluid pump. It is acknowledged herein that in some embodiments, valves are provided instead of taps or ports.

In a preferred embodiment of the invention, the dilating balloon is adapted to maintain a pressure of between about 0.5 ATM and about 2.0 ATM during the duration of treatment.

In another embodiment of the invention taps or ports are provided with means for withdrawal and reinsertion from the interior of the urethral meatus.

In some embodiments of the device the taps or ports are further provided with means for coupling with an external fluid pump or other inflating means.

In some embodiments of the device the lumens are adapted to be inflated independently via the taps.

In some embodiments of the device the urethral dilating balloon is adapted to accommodate a diagnostic sensor or probe.

In some embodiments of the device at least one of the lumens is adapted to accommodate diagnostic sensors or probes.

Some embodiments of the device comprise lumens adapted to accommodate therapeutic means. The aforementioned therapeutic means are selected from a group consisting of cryogenic, thermal, radiofrequency, microwave, fibre optic, cauterization, laser or any combination thereof.

It is herein acknowledged that all or some of the lumens and portions of the device are adapted for injecting or removing fluids, especially medicaments.

It is further acknowledged that some embodiments of the device are provided with a multiplicity of lumens, each lumen adapted for mediating specific functions selected from a group consisting of power supply, illumination, inner pressure control and adjustment, administration of medicaments, replenishing of medicaments, drainage of a portion of the implanted device, external video monitoring, administration of therapies, and withdrawal of biopsy samples.

It is further acknowledged herein that an inner portion of the device, especially the inflatable dilating balloon is provided with an internal NIRS sensor unit for monitoring and diagnosing processes within the prostatic urethra, prostate and surrounding and associated tissues.

It is further acknowledged herein that the inflatable dilating balloon is adapted to allow the aforementioned NIRS sensor unit to be withdrawn from the inflatable dilating balloon via the lumen so that data recorded can be studied after withdrawal.

It is further acknowledged herein that in some embodiments, a Wireless NIRS sensor unit is provided with means for wirelessly transmitting data concerning the prostatic urethra, prostate and surrounding and associated tissues to an external monitor.

It is further acknowledged herein that in some embodiments of the invention an inner portion of the device is provided with means for providing therapeutic vibrations. These vibrations are preferably ultrasonic.

It is further acknowledged herein that in some embodiments of the invention an inner portion of the device, preferably the inflatable dilation balloon is provided with heating means.

It is further acknowledged herein that in some embodiments of the invention the inner portion is provided with cooling means.

It is yet further acknowledged that in some embodiments, the cooling means is a peltier device or a saline circulation system.

In some embodiments of the device the urethral dilating balloon is provided with sustained drug release means and is further adapted to be semi permeable such that predetermined therapeutic doses of drugs may be released from the interior of the urethral dilating balloon into contact with prostatic or urethral tissue. In some embodiments of the device at least one of the lumens are, for at least a portion of their length, accommodated within a lumen sheath.

A method of dilating a stenotic male urethra is disclosed. The preferred method comprises the following steps. Firstly the following is obtained; a. a flexible urinary catheter b. an adjustable distal bladder anchoring means, c. a first flexible inflating/deflating lumen.

Connecting and fluidly communicating the anchoring means via the first lumen with the proximal portion of the urethra.

Further steps of the disclosed method comprise obtaining; d. an adjustable proximal anchoring means e. a second flexible inflating/deflating lumen

Connecting and fluidly communicating the adjustable proximal anchoring means via the second lumen with the proximal portion of the urethra.

Yet further steps of the disclosed method comprise further obtaining a radially adjustable urethral dilating balloon, a third flexible inflating/deflating lumen, and connecting and fluidly communicating the dilating balloon via the third lumen with the proximal portion of said urethra.

Further steps of the method comprise optionally deploying the distal bladder anchoring means within the bladder and optionally deploying said proximal anchoring means , wherein the method further comprises steps of deploying the urinary catheter within the urethra, terminating proximal ends of said lumens with inflating and deflating fluid taps, and accommodating the taps or portswithin the urethral meatus, withdrawing at least the fluid tap connected to the third lumen, coupling the fluid tap to an external fluid pump or pressurized fluid supply and inflating said dilating balloon therewith. The method further comprises steps of reversibly coupling the distal bladder anchoring means tap to an external fluid pump or pressurized fluid supply and inflating the bladder anchoring means therewith.

The method additionally comprises steps of reversibly coupling the proximal anchoring means tap to an external fluid pump or pressurized fluid supply and inflating the anchoring means therewith.

The method further comprises steps of inflating the dilating balloon to a pressure of between about 0.5 ATM and about 2.0 ATM during the duration of treatment.

The method further comprises steps of withdrawing and reinserting the taps or ports from the interior of the urethral meatus.

The method further comprises steps of coupling the taps or portswith an external fluid pump or other inflating means.

The method further comprises steps of adapting the catheter such that the proximal end of the catheter extends only up to distal side of the penile sphincter.

The method further comprises steps of independently inflating the lumens via the taps.

That is to say, the bladder anchoring means, the dilating balloon and the distal anchoring means can be inflated independently of each other via the tap and connecting lumen of each .

The method further comprises steps of accommodating a diagnostic sensor or probe in the urethral dilating balloon.

The method further comprises steps of accommodating diagnostic sensors or probes within the lumens.

The method further comprises adapting lumens to accommodate therapeutic means.

The method further comprises steps of selecting therapeutic means from a group consisting of cryogenic, thermal, radiofrequency, microwave, fibre optic, cauterization, laser or any combination thereof.

The method further comprises steps of providing the urethral dilating balloon with a permeable wall and sustained drug release means such that predetermined therapeutic doses of drugs may be released from the interior of the urethral dilating balloon into contact with prostatic or urethral tissue.

Lastly, the method comprises steps of accommodating within a lumen sheath at least one of the lumens for at least a portion of their length.

The figures disclosed herein describe implants wherein the expandable member is a balloon, only as an example. However, it is noted that according to other embodiments of the invention, implants having other expandable members, such as stents (which may optionally be covered), expanding arms, wings, or any other appropriate element, may be used.

It is herein further acknowledged that a core aspect of the current invention is to disclose a device provided with means for coating the interior walls of an internal organ with a medicinal substance introduced via any of the lumens. Any of the anchoring means or dilating balloons are adapted to essentially fill and contact a substantial portion of the said internal organ's interior walls to be treated. Thus, a medicinal substance, drug, medicament, can be coated , spread or smeared on the inner wall of , for example , the bladder by first introducing the substance into the bladder, and then manipulating, maneuvering, dilating and extending the anchoring means or dilating balloon to fill the bladder and to come into contact with the inner wall. The interior of the bladder wall can be coated in this way with a biodegradable therapeutic gel. In embodiments of the invention, the gel is introduced via the distal bladder anchoring means lumen, and the distal bladder anchoring means is adapted to essentially fill and contact the entire volume of said bladder to be treated.

Some embodiments of the invention are adapted for introducing the device into any region of the Gastro intestinal tract via the mouth or rectum. Some embodiments of the device are adapted for widening a stenotic bile duct. Some embodiments of the device are provided with means for coating at least part of the interior portion of the gastro intestinal tract. Coated regions can be the lower intestine, any part of the stomach, or the anal-rectal region. Of course, other shapes or forms of implants are also possible are not limited by any of the drawings.

In the description and claims of the application, each of the words "comprise" "include" and "have", and forms thereof, are not necessarily limited to members in a list with which the words may be associated.

The invention has been described using various detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the invention. The described embodiments may comprise different features, not all of which are required in all embodiments of the invention. Some embodiments of the invention utilize only some of the features or possible combinations of the features. Variations of embodiments of the invention that are described and embodiments of the invention comprising different combinations of features noted in the described embodiments will occur to persons with skill in the art. It is intended that the scope of the invention be limited only by the claims and that the claims be interpreted to include all such variations and combinations.

Claims

1 A device for dilating a stenotic urethra, said device comprising a. flexible urinary catheter b. an adjustable distal bladder anchoring means fluidly communicating with the proximal portion of said urethra via an elongatable stretchable inflating/deflating lumen c. an adjustable proximal anchoring means fluidly communicating with the proximal portion of said urethra via an elongatable stretchable inflating/deflating lumen d. a radially adjustable urethral dilating balloon fluidly communicating with the proximal portion of said urethra via an elongatable stretchable inflating/deflating lumen wherein said stretchable lumens are proximally terminated with inflating and deflating fluid taps or ports, said lumens accommodated within said urethra whilst said lumens are in their unstretched state, further wherein the bores of said lumens are in fluid communication with their respective anchoring means and dilating balloons when said lumens are in a stretched state, further wherein said taps or ports are accommodated within the urethral meatus and are adapted to be withdrawn therefrom during treatment sessions.

2. The device according to claim 1 wherein said lumens are preferably elongatable up to about 2 to 3 times their length in a relaxed state whilst remaining in a state of fluid communication during and after elongation.

3. The device according to claim 2 wherein said lumens are adapted to be stretched from about 5 cms. to between about 10 cms up to about 15 cms.

4. The device according to claim 2 wherein said lumens are adapted to be stretched from about 10 cms. to between about 20 cms up to about 30 cms.

5. The device according to claim 1 wherein the dilating means tap or port is adapted to be reversibly coupled to an external fluid pump.

6. The device according to claim 1 wherein said dilating balloon is adapted to maintain a pressure of between about 0.5 ATM and about 2.0 ATM during the duration of treatment.

7. The device according to claim 1 wherein said taps or ports are provided with means for withdrawal and reinsertion from said urethral meatus interior.

8. The device according to claim 1 wherein said taps or ports are further provided with means for coupling with an external fluid pump or other inflating means.

9. The device according to claim 1 wherein proximal end of said catheter extends only up to the distal side of the penile sphincter.

10. The device according to claim 1 wherein each of said lumens is adapted to be inflated independently or contemporaneously via said taps or ports

11. The device according to claim 1 wherein said urethral dilating balloon is adapted to accommodate a diagnostic sensor or probe.

12. The device according to claim 1 wherein said lumens are adapted to accommodate diagnostic sensors or probes.

13. The device according to claim 1 wherein said lumens are adapted to accommodate therapeutic means.

14. The device according to claim 1 wherein said therapeutic means are selected from a group consisting of cryogenic, thermal, radiofrequency, microwave, fibre optic, cauterization, laser or any combination thereof.

15. The device according to claim 1 wherein said urethral dilating balloon is provided with sustained drug release means and is further adapted to be semi permeable such that predetermined therapeutic doses of drugs may be released from the interior of the urethral dilating balloon into contact with prostatic or urethral tissue.

16. The device according claim 15 wherein said drugs are selected from a group consisting of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), steroid agents, antibiotics, chemotherapeutics, radio-therapeutics, antiviral drugs, a diagnostic agent or any other medicine and/or diagnostic agent.

17. The device according to claim 1 wherein at least one of said lumens are for at least a portion of their length, accommodated within a stretchable lumen sheath.

18. The device according to claim 1 wherein said device is provided with means for coating the interior walls of an internal organ with a medicinal substance introduced via any of said lumens, further wherein any of said anchoring means or dilating balloons are adapted to essentially fill and contact a substantial portion of the said internal organ's interior walls to be treated.

19. The device according to claim 15 wherein said medicinal substance is selected from a group consisting of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), steroid agents, antibiotics, chemotherapeutics, radio-therapeutics, antiviral drugs, a diagnostic agent or any other medicine and/or diagnostic agent.

20. The device according to claim 1 wherein said device is provided with means for coating the interior of said bladder wall with a biodegradable therapeutic gel when said gel is introduced via said distal bladder anchoring means lumen, further wherein said distal bladder anchoring means is adapted to essentially fill and contact the entire volume of said bladder to be treated.

21. The device according to claim 1 wherein said device is adapted for introducing into any region of the Gastro intestinal tract via the mouth or rectum

22. The device according to claim 20 wherein said device is adapted for widening a stenotic bile duct

23. The device according to claim 20 wherein said device is provided with means for coating at least part of the interior portion of the gastro intestinal tract.

24. The device according to claim 21 wherein said interior portion of the gastro intestinal tract is the upper portion.

25. The device according to claim 21 wherein said interior portion of the gastro intestinal tract is the lower intestine.

26. The device according to claim 21 wherein said interior portion of the gastro intestinal tract is any part of the stomach.

27. The device according to claim 21 wherein said interior portion of the gastro intestinal tract is the anal - rectal region.

28. A method of dilating a stenotic male urethra, said method comprising steps of obtaining a. a flexible urinary catheter b. an adjustable distal bladder anchoring means, c. a first flexible elongeatable inflating/deflating lumen d. connecting and fluidly communicating said anchoring means via said first lumen with the proximal portion of said urethra, further obtaining e. an adjustable proximal anchoring means f. a second flexible elongeatable inflating/deflating lumen g. connecting and fluidly communicating said adjustable proximal anchoring means via said second lumen with the proximal portion of said urethra further obtaining a radially adjustable urethral dilating balloon h. a third flexible elongeatable inflating/deflating lumen i. connecting and fluidly communicating said dilating balloon via said third lumen with the proximal portion of said urethra j. optionally deploying said distal bladder anchoring means within said bladder k. optionally deploying said proximal anchoring means wherein said method further comprises steps of deploying said urinary catheter within said urethra, terminating proximal ends of said lumens with inflating and deflating fluid taps, and accommodating said taps or ports within the urethral meatus, withdrawing at least said fluid tap connected to said third lumen, thereby elongating said third lumen along the whole length of the penis and coupling said fluid tap to an external fluid pump or pressurized fluid supply and inflating said dilating balloon therewith.

29. The method according to claim 28 wherein said method comprises steps of reversibly coupling the distal bladder anchoring means tap to an external fluid pump or pressurized fluid supply and inflating said bladder anchoring means therewith.

30. The method according to claim 28 wherein said method comprises steps of reversibly coupling the proximal anchoring means tap to an external fluid pump or pressurized fluid supply and inflating said anchoring means therewith.

31. The method according to claim 28 wherein said method comprises steps of inflating said dilating balloon to a pressure of between about 0.5 ATM and about 2.0 ATM during the duration of treatment.

32. The method according to claim 28 wherein said method comprises steps of withdrawing and reinserting said taps or ports from said urethral meatus interior.

33. The method according to claim 28 wherein said method comprises steps of coupling said taps or ports with an external fluid pump or other inflating means.

34. The method according to claim 28 wherein said method comprises steps of inflating lumens via said taps or ports independently.

35. The method according to claim 28 wherein said method comprises steps of accommodating a diagnostic sensor or probe in said urethral dilating balloon.

36. The method according to claim 28 wherein said method comprises steps of accommodating said diagnostic sensors or probes within said lumens.

37. The method according to claim 28 wherein said lumens are adapted to accommodate therapeutic means.

38. The method according to claim 28 wherein said method comprises steps of selecting said therapeutic means from a group consisting of cryogenic, thermal, radiofrequency, microwave, fibre optic, cauterization, laser or any combination therof.

39. The method according to claim 28 wherein said method comprises steps of providing said urethral dilating balloon with a permeable wall and sustained drug release means such that predetermined therapeutic doses of drugs may be released from the interior of the urethral dilating balloon into contact with prostatic or urethral tissue.

40. The method according to claim 28 wherein said method comprises steps of accommodating within a lumen sheath at least one of said lumens for at least a portion of their length.

41. A method for delivering a therapeutic substance to an internal organ wherein said method comprises steps of i. providing means for coating or smearing the interior walls of an internal organ with a medicinal substance ii. introducing said substance via any of said lumens, said method further characterized by inflating any of said anchoring means or dilating balloons to essentially fill and contact a substantial portion of the said internal organ's interior walls to be treated iii. delivering said substance to said interior walls of said organ and inflating and otherwise manipulating said anchoring means, thereby coating or smearing said interior walls .

42. The method according to claim 41 wherein said method comprises steps of introducing a biodegradable therapeutic gel said distal bladder - anchoring means lumen, further wherein said method comprises steps of inflating or extending said distal bladder anchoring means to essentially fill and contact the entire volume of said bladder to be treated.

43. The method according to claim 41 wherein said method comprises steps of adapting said device for introducing into any region of the Gastro intestinal tract via the mouth or rectum.

44. The method according to claim 28 wherein said method comprises steps of adapting said device for widening a stenotic bile duct

45. The method according to claim 41 wherein said device is provided with means for coating at least part of the interior portion of the gastro intestinal tract.

46. The method according to claim 45 wherein said interior portion of the gastro intestinal tract is the upper portion.

47. The method according to claim 45 wherein said interior portion of the gastro intestinal tract is the lower intestine.

48. The method according to claim 45 wherein said interior portion of the gastro intestinal tract is any part of the stomach.

49. The method according to claim 45 wherein said interior portion of the gastro intestinal tract is the anal - rectal region.