Patent Application
20090018385
The present invention relates to a urethra pressure control adjustable valve which is implantable in a patient to cause the urethra to open and close to discharge liquid from the bladder by sphincter muscle control.
Urinary incontinence is defined as the accidental leakage of urine through the urethra. Prostate problems and post radical prostatectomy urinary incontinence greatly affects a matters quality of life. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has reported that urinary incontinence is a medical problem and that there are four forms of urinary incontinence. These are (1) temporary and reversible incontinence related to urinary track infection, constipation or delirium; (2) stress incontinence caused by weak pelvic and sphincter muscles; (3) urgent continence caused by damaged or iritatable nerves; and (4) overflow incontinence that results when an individual is unable to empty the bladder.
The urinary system, to do its job, muscles and nerves must work together to hold urine in the bladder and then release it at the right moment. A person develops the sphincter muscle control as a normal phenomenon associated with nerve signals. These muscles cause the bladder to squeeze and exude liquid therefrom.
The present invention is particularly concerned, but not exclusively, with a urethra pressure control adjustable valve which essentially replaces the prostate in men. The prostate is a male gland about the size and shape of a walnut that surrounds the urethra immediately below the bladder. To treat prostate cancer the prostate gland is usually surgically removed and this could cause problems to the muscles that control the bladder amongst other side effects. The loss of control by the bladder muscles will cause uncontrollable leakage. Various methods and devices have been developed to try and treat this problem. One such treatment is to insert a catheter through the urethra to drain the bladder. The catheter then leads to a bag in which the fluid from the bladder is collected. A major problem with these catheters is that they often develop infections and stone formation not to mention the discomfort of carrying and empting bag on a regular basis. They also require frequent disinfecting and cleaning. Cauterization is usually done by a doctor but a patient may be easily trained to effect the procedure himself. To do this, there is a need to learn sterile techniques to avoid urinary track infections.
A more recent technique is to use an artificial sphincter which is implanted adjacent the urethra below the bladder to keep the urethra closed until it is time to urinate. As reported in medical publications, this device can help people who have incontinence because of weak sphincter muscles or because of nerve damage that interferes with sphincter muscle function. It does not solve incontinence caused by uncontrolled bladder contraction. Artificial sphincters consist of a cup that fits around the urethra with a small balloon reservoir placed in the abdomen and a pump placed in the scrotum. The cup is filled with a liquid that makes it fit tightly around the urethra to squeeze the urethra to prevent urine from leaking. When it is time to urinate you squeeze the pump with the fingers to deflate the cup so that the liquid moves to the balloon reservoir from the cuff and urine can now flow through the urethra. When the bladder is emptied, the cup automatically refills within a time delay of about 2 to 5 minutes to keep the urethra tightly closed. This solution has not been found to work efficiently and requires interaction with the user to release the urine.
In recent years a new procedure has been developed to treat urinary incontinence. This new procedure comprises implanting a balloon which is connected to a conduit tube with the conduit tube remaining inside a person's body and the balloon is positioned adjacent the urethra whereby upon inflation of the balloon, through the scrotum, the urethra will be squeezed and hopefully close. The tube is provided with an inlet port positioned in the scrotum and through which a fluid is injected by a syringe, through the skin of the scrotum, whereby to inject a proper amount of fluid in the balloon to expand it to apply sufficient pressure against the urethra. This technique has also encountered various problems, and it has been reported that the success rate is no better than fifty percent (50%). A major problem with this technique is that the urethra is unstable and when pressure is applied against it the urethra will be displaced in an uncontrollable manner. The balloons are also unstable. This is why the efficiency rate has not been satisfactory. Usually there are two of these balloons that are implanted one on opposed sides of the urethra and sometimes offset from one another. Reference to U.S. Pat. Nos. 6,045,498 and 6,445,138 describes such implantable devices and their operation.
As reported in Medical News Today, Newsletter dated Oct. 24, 2006, these balloons are implanted beneath the bladder neck to increase its resistance. The novel difference with this device is the ability to adjust the tightness of the urethral occlusion by altering the amount to fluid in each balloon via a titanium port connector that can be accessed via a percutaneous injection in the scrotum. A study of this technique is also reported in the May 2006 issue of Urology. With this technique balloon adjustment is required to achieve continence and the average number of adjustments was 4.6, all of which were done in an out patient setting and in first six months after placement. A revision surgery was also required in four of twenty-three patients.
The above-mentioned technique appears to be on course to eventually resolve problems associated with balloon implants. However, there is still a need to resolve major problems with this technique such as the assurance that the implant will effectively engage the urethra and effect proper closure thereof by applying a pressure customized to the patient's needs depending on his degree of control to evacuate urine from the bladder. Another problem to be resolved is the implantation of the device itself about the urethra to effectively assure the proper function thereof prior to closing the incision.
It has also been reported by NIDDK that women experience incontinence twice as often as men. Pregnancy and childbirth, menopause, and the structure of the female urinary tract account for this difference. But both women and men can become incontinent from neurologic injury, birth defects, strokes, multiple sclerosis and physical problems associated with aging. Incontinence in women usually occurs because of problems with muscles that help to hold or release urine.
Many types of treatments are used to treat incontinence in women, depending in the severity of their problem, such as exercises, electrical stimulation, biofeedback timed voiding or bladder training, medications, pessaries, implants, surgery and catherization.
It is a feature of the present invention to provide a surgically implantable urethra pressure control adjustable valve which substantially overcomes the above-mentioned disadvantages of the prior art.
Another feature of the present invention is to provide a surgically implantable urethra pressure control adjustable valve which is easy to install and provides visibility to the surgeon when positioning the valve and its pressure control means against the urethra.
Another feature of the present invention is to provide a surgically implantable urethra pressure control adjustable valve, the closing pressure of which is adjustable through the scrotum or elsewhere by injecting fluid into a balloon retained in the valve through a conduit provided with a port connector located in the scrotum or elsewhere.
According to the above features, from a broad aspect, the present invention provides a surgically implantable urethra pressure control adjustable valve. The valve is comprised of a clamp positionable about a urethra in a patient's body. The clamp has a retention wall having a first and a second opening. The first and second openings are oppositely spaced-apart to provide for the passage of the urethra through the retention wall. Pressure abutment means is provided inside the circumferential wall and disposed adjacent opposed inner wall surfaces of the retention wall on opposed sides of the urethra. At least one of the pressure abutment means is actuable to expand to apply a contained controlled pressure against the urethra to close the urethra by pinching same between said pressure abutment means. The contained controlled pressure is adjustable and selected so that liquid pressure from a bladder associated with the urethra and under pressure by muscle control will cause the urethra to open against the contained controlled pressure to discharge liquid from the bladder and to automatically close once the pressure from the bladder is discontinued by muscle control.
A preferred embodiment of the present invention will now be described with reference to the accompanying drawings in which:
Referring now to the drawings and more particularly to
Pressure abutment means is provided in the form of a balloon 17 which is retained at a precise location inside the circumferential wall 14 by a locating through bore 9 through which the conduit of the balloon is retained. The balloon is disposed between an inner wall surface 18 of the circumferential wall 14 and the urethra 11 whereby to apply a contained control pressure against the urethra to cause the urethra to close by pinching same against a diametrically opposed abutment means, herein an immovable abutment shoulder or rib 19. This shoulder 19 is molded integral with the circumferential wall 14 and projects inwardly therein. The contained control pressure within the balloon 17 is provided by a fluid which is injected into the balloon 17 through the conduit 20. The conduit 20 is provided with a port connector 21 which is located within the scrotum against the inside surface of the outer skin 23 thereof for a male patient and under the skin at a convenient location for a female patient. A syringe 22 is used to inject the fluid through the skin 23. The port connector 21 is of a type well known in the art and prevents back leakage of the fluid. Accordingly, by controlling the amount of fluid injected in the balloon the pressure against the urethra can be controlled.
The advantages of the pressure control adjustable valve design of the present invention provides many advantages over the prior art. One such advantage is that the circumferential wall 14 defines opposed open sides 24 to provide visibility to the surgeon to the first and second openings 15 and 16, and to the position of the urethra between the immovable abutment shoulder 19 and the pressure abutment balloon 17, as clearly shown in
A still further important characteristic of the valve 10 of the present invention is that the first and second openings 15 and 16 are in the form of apertures in the circumferential wall 14 and are provided with a slot entrance opening in a side edge 14′ of the ring-shaped clamp. As shown more clearly in
Referring now to
The free ends 33 and 32 of the clamp 30 are designed to interconnect together by an adjustable connector 36 whereby to adjust the distance between the ends of the formations 34 and 35 to clamp the urethra 11 therebetween. It is pointed out that the circumferential wall 31 is very thin in its portions where it is free of the formations 34 and 35 whereby to provide for a contained control pressure of the formation 34 against the urethra.
As shown in
To adjust the proper pressure, to pinch the urethra closed with a selected pressure, the adjustable connector 36 is constituted by at least two or more transverse notches 46 formed in the curved end wall 41′ and with the free end of the side wall 40′ being provided with a straight engaging end formation 47 to engage under pressure within a selected one of the notches 46. Accordingly, when this valve is installed, the proper pressure notch is selected to suit the patient as this pressure cannot be controlled from the exterior after it has been implanted. Such clamp is therefore suitable for only certain patient incontinence disorders which are more easily controllable. The adjustable connector 36 is also designed to prevent accidental disconnection.
Referring now to
The clamp 70 is constructed of a flexible material suitable for implantation and wherein by flexing the wall portion 75 on either side of the slot opening, the slot opening 72 can be enlarged whereby to permit passage of the urethra therethrough. Thereafter the memory of the material forming the retention wall re-assumes its position thereby preventing the urethra from sliding out of the clamp. It is pointed out that the drawings as illustrated in
As shown in these drawings the ring-like shaped clamp 70 is an oval-shaped clamp having opposed elongated top and bottom walls 76 and 77, respectively and opposed curved side walls 78 and 78′. The slot opening 72 extends across the bottom wall 77 and substantially centrally therein.
The pressure abutment means is herein constituted by a pair of balloons 79 and 79′ retained against the inner surfaces 80 and 80′ of the curved side walls 78 and 78′, respectively, and this is accomplished by locating the conduits 81 and 81′, respectively, connected to these balloons through bores 82 and 82′ formed in these curved side walls. Connectors 83 and 83′ connect the conduits 81 and 81′, respectively, to these curved side walls. These balloons 79 and 79′ are assembled with the ring-like shaped clamps 70 during manufacture and as shown in
Referring now to
As shown in
It is within the ambit of the present invention to cover any obvious modifications of the examples of the preferred embodiment described herein provided such modifications fall within the scope of the appended claims.
