WO2008132735A1 - Implant urétral et procédé associé - Google Patents

Implant urétral et procédé associé Download PDF

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Publication number
WO2008132735A1
WO2008132735A1 PCT/IL2008/000559 IL2008000559W WO2008132735A1 WO 2008132735 A1 WO2008132735 A1 WO 2008132735A1 IL 2008000559 W IL2008000559 W IL 2008000559W WO 2008132735 A1 WO2008132735 A1 WO 2008132735A1
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WO
WIPO (PCT)
Prior art keywords
urethra
lumens
inflating
lumen
balloon
Prior art date
Application number
PCT/IL2008/000559
Other languages
English (en)
Inventor
Hamid Sharim
Shmuel Beck
Original Assignee
Mediflow Medical Solutions Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mediflow Medical Solutions Ltd. filed Critical Mediflow Medical Solutions Ltd.
Publication of WO2008132735A1 publication Critical patent/WO2008132735A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0022—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed deep in the body opening
    • A61F2/0027—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed deep in the body opening inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
    • A61M27/008—Implant devices for drainage of body fluids from one part of the body to another pre-shaped, for use in the urethral or ureteral tract
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections

Definitions

  • the invention relates to methods and apparatus for facilitating urination.
  • 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.
  • 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.
  • the prostate 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.
  • urethral stenosis 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.
  • 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.
  • BPH prostatic hyperplasia
  • Surgeries include open surgeries and transurethral resection of the prostate (TURP or TUR).
  • TURP an instrument is inserted through the urethra to remove prostate tissue that is pressing against the urethra and restricting the flow of urine.
  • 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.
  • 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.
  • stenosis refers to an abnormal narrowing in a blood vessel or other tubular organ or structure, such as but not limited to, a urethra.
  • 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.
  • 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.
  • 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.
  • a scar tissue and/or connective tissue such as fibrous connective tissue (fibrosis)
  • the scar tissue and/or connective tissue in the prostate area surrounding the urethra substantially assumes a shape determined by the shape of implant.
  • 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.
  • 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
  • the expanded element 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.
  • a scar tissue and/or connective tissue in the prostate area surrounding the urethra substantially assumes a shape determined by the shape of implant.
  • 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.
  • 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.
  • the lumens and tubes which communicate between balloons or expandable or inflatable members are all highly stretchable and elongatable and variable in length.
  • the distal ends 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.
  • 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.
  • a medicament for example, the implant's surface
  • diagnostic agents and/or nutrient(s) adapted to treat, ameliorate and/or prevent a prostate and/or urethral related condition or disorder.
  • 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.
  • the implant may at least partially undergo degradation or dissolve in the body.
  • 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.
  • a method of improving urine flow 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.
  • 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.
  • 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.
  • 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
  • FIG. 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the bores of any of the stretchable lumens is at all times sufficiently wide as to allow fluid communication.
  • 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%.
  • stretchable and “elongatable” are used interchangeably .
  • 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 is thereby permanently fixed in an expanded shape, restoring normal urinary function to the patient.
  • 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.
  • 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.
  • FIG. 1 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.
  • 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.
  • 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.
  • 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.
  • the expandable element such as the deflated balloon 304
  • the expandable element 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.
  • 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').
  • fluid for example excess of fluid
  • each balloon is independently attached and communicates with, it's own independent lumen. Thus each balloon may be adjusted and controlled separately.
  • 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.
  • 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.
  • 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.
  • the stopper 408 is adapted to be located in the bladder.
  • the expandable element such as the deflated balloon 404
  • the expandable element 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'
  • 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.
  • the fluid flows through the secondary inflation tube 410 to the stopper 408 and the pressure in balloon 404 is relieved.
  • fluid can be filled in the stopper 408 through a separate tube (not shown), which is not directly connected to the balloon 404.
  • 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').
  • fluid may be extracted from the balloon (such as the inflated balloon 404').
  • inflated balloon may include any degree of inflation, partially inflated through fully inflated.
  • the addition and extraction of fluid to and from the implant 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.
  • 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.
  • Fig. 5 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).
  • 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.
  • 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.
  • 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.
  • the fluid flows through the secondary inflation tube 510 to the stopper 508 and the pressure in balloon 504 is relieved.
  • fluid can be filled in the stopper 508 through a separate tube (not shown), which is not directly connected to the balloon 504.
  • additional fluid may be inserted into the balloon 504.
  • fluid may be extracted from the balloon 504 to relief the pressure or to remove the implant.
  • 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.
  • 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
  • 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,
  • implants 600 and 700 respectively may include stoppers (not shown).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • taps or ports are provided with means for withdrawal and reinsertion from the interior of the urethral meatus.
  • the taps or ports are further provided with means for coupling with an external fluid pump or other inflating means.
  • the lumens are adapted to be inflated independently via the taps.
  • the urethral dilating balloon is adapted to accommodate a diagnostic sensor or probe.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • an inner portion of the device is provided with means for providing therapeutic vibrations. These vibrations are preferably ultrasonic.
  • an inner portion of the device preferably the inflatable dilation balloon is provided with heating means.
  • the inner portion is provided with cooling means.
  • the cooling means is a peltier device or a saline circulation system.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • the method comprises steps of accommodating within a lumen sheath at least one of the lumens for at least a portion of their length.
  • implants wherein the expandable member is a balloon, only as an example.
  • implants having other expandable members such as stents (which may optionally be covered), expanding arms, wings, or any other appropriate element, may be used.
  • 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.
  • 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.
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Urology & Nephrology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Otolaryngology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Cette invention se rapporte à un implant destiné à être utilisé dans le traitement, l'amélioration et/ou la prévention de la sténose de l'urètre. L'implant est adapté pour être inséré dans l'urètre, en particulier au moins dans une partie de la zone prostatique de l'urètre (la partie de l'urètre qui passe par la prostate), et pour exercer une pression, par exemple, une pression périphérique contre la prostate, tout en permettant l'écoulement de l'urine. La pression exercée par l'implant sur la prostate « pousse » la partie qui est en contact direct avec et/ou à proximité de l'implant, et l'écarte de la partie prostatique de l'urètre.
PCT/IL2008/000559 2007-04-25 2008-04-27 Implant urétral et procédé associé WO2008132735A1 (fr)

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US60/907,966 2007-04-25

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Cited By (17)

* Cited by examiner, † Cited by third party
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DE102011110778A1 (de) * 2011-07-21 2013-01-24 Ullrich Otto Katheter, insbesondere Verweilkatheter, zur Behandlung von Funktionsstörungen und/oder Erkrankungen der Blase und/oder der Prostata
CN104644217A (zh) * 2015-02-08 2015-05-27 沈兰辉 肾盂造影用膀胱充盈辅助器
US10105132B2 (en) 2005-05-20 2018-10-23 Neotract, Inc. Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
US10130353B2 (en) 2012-06-29 2018-11-20 Neotract, Inc. Flexible system for delivering an anchor
US10143461B2 (en) 2005-05-20 2018-12-04 Neotract, Inc. Devices, systems and methods for retracting, lifting, compressing, supporting or repositioning tissues or anatomical structures
US10195014B2 (en) 2005-05-20 2019-02-05 Neotract, Inc. Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
US10265061B2 (en) 2005-05-20 2019-04-23 Neotract, Inc. Latching anchor device
US10292801B2 (en) 2012-03-29 2019-05-21 Neotract, Inc. System for delivering anchors for treating incontinence
US10299780B2 (en) 2005-05-20 2019-05-28 Neotract, Inc. Apparatus and method for manipulating or retracting tissue and anatomical structure
US10426509B2 (en) 2005-05-20 2019-10-01 Neotract, Inc. Median lobe destruction apparatus and method
US10492792B2 (en) 2005-05-20 2019-12-03 Neotract, Inc. Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
CN112121288A (zh) * 2020-10-20 2020-12-25 常州市金坛区人民医院 一种持续性前列腺水囊扩张系统
US10925587B2 (en) 2005-05-20 2021-02-23 Neotract, Inc. Anchor delivery system
CN113274624A (zh) * 2021-07-06 2021-08-20 中南大学湘雅医院 一种可视化尿道扩张术后治疗仪
CN113633835A (zh) * 2021-08-12 2021-11-12 复旦大学附属中山医院 一种可扩张胆道狭窄部的引流管
CN113647907A (zh) * 2021-08-06 2021-11-16 温州市人民医院 一种实验鼠肠道敏感性测试设备
US11672520B2 (en) 2017-12-23 2023-06-13 Teleflex Life Sciences Limited Expandable tissue engagement apparatus and method

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US5527336A (en) * 1986-12-09 1996-06-18 Boston Scientific Corporation Flow obstruction treatment method
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Cited By (27)

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US10575844B2 (en) 2005-05-20 2020-03-03 Neotract, Inc. Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
US10299780B2 (en) 2005-05-20 2019-05-28 Neotract, Inc. Apparatus and method for manipulating or retracting tissue and anatomical structure
US11090036B2 (en) 2005-05-20 2021-08-17 Neotract, Inc. Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
US10105132B2 (en) 2005-05-20 2018-10-23 Neotract, Inc. Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
US10945719B2 (en) 2005-05-20 2021-03-16 Neotract, Inc. Devices, systems and methods for retracting, lifting, compressing, supporting or repositioning tissues or anatomical structures
US10143461B2 (en) 2005-05-20 2018-12-04 Neotract, Inc. Devices, systems and methods for retracting, lifting, compressing, supporting or repositioning tissues or anatomical structures
US10195014B2 (en) 2005-05-20 2019-02-05 Neotract, Inc. Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
US10265061B2 (en) 2005-05-20 2019-04-23 Neotract, Inc. Latching anchor device
US10925587B2 (en) 2005-05-20 2021-02-23 Neotract, Inc. Anchor delivery system
US11471148B2 (en) 2005-05-20 2022-10-18 Teleflex Life Sciences Limited Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
US10426509B2 (en) 2005-05-20 2019-10-01 Neotract, Inc. Median lobe destruction apparatus and method
US10492792B2 (en) 2005-05-20 2019-12-03 Neotract, Inc. Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
US11504149B2 (en) 2005-05-20 2022-11-22 Teleflex Life Sciences Limited Median lobe destruction apparatus and method
DE102011110778B4 (de) * 2011-07-21 2016-03-17 Ullrich Otto Katheter, insbesondere Verweilkatheter, zur Behandlung von Funktionsstörungen und/oder Erkrankungen der Blase und/oder der Prostata
DE102011110778A1 (de) * 2011-07-21 2013-01-24 Ullrich Otto Katheter, insbesondere Verweilkatheter, zur Behandlung von Funktionsstörungen und/oder Erkrankungen der Blase und/oder der Prostata
US10292801B2 (en) 2012-03-29 2019-05-21 Neotract, Inc. System for delivering anchors for treating incontinence
US11331093B2 (en) 2012-06-29 2022-05-17 Teleflex Life Sciences Limited Flexible system for delivering an anchor
US10130353B2 (en) 2012-06-29 2018-11-20 Neotract, Inc. Flexible system for delivering an anchor
US11850140B2 (en) 2013-03-14 2023-12-26 Teleflex Life Sciences Limited Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
US10912637B2 (en) 2013-03-14 2021-02-09 Neotract, Inc. Devices, systems and methods for treating benign prostatic hyperplasia and other conditions
CN104644217A (zh) * 2015-02-08 2015-05-27 沈兰辉 肾盂造影用膀胱充盈辅助器
US11672520B2 (en) 2017-12-23 2023-06-13 Teleflex Life Sciences Limited Expandable tissue engagement apparatus and method
CN112121288A (zh) * 2020-10-20 2020-12-25 常州市金坛区人民医院 一种持续性前列腺水囊扩张系统
CN113274624A (zh) * 2021-07-06 2021-08-20 中南大学湘雅医院 一种可视化尿道扩张术后治疗仪
CN113274624B (zh) * 2021-07-06 2023-05-12 中南大学湘雅医院 一种可视化尿道扩张术后治疗仪
CN113647907A (zh) * 2021-08-06 2021-11-16 温州市人民医院 一种实验鼠肠道敏感性测试设备
CN113633835A (zh) * 2021-08-12 2021-11-12 复旦大学附属中山医院 一种可扩张胆道狭窄部的引流管

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