Abstract:
A surgically implantable urethra pressure control valve is described. It comprises a clamp having a pair of spaced-apart clamping arms. A urethra passage is defined between the clamping arms. At least one of the clamping arms is a displaceable clamping arm movable towards the other clamping arm to a predetermined position spaced from the other clamping arm a distance sufficient to pinch and close an inner passage of the urethra when disposed in the urethra passage whereby to arrest the flow of urine. An actuator is provided to effect the displacement of the displaceable clamping arm. The actuator may be a remote control to operate the valve or an implanted sphincter to apply a closing pressure upon the urethra.

Description:
TECHNICAL FIELD 
       [0001]    The present invention relates to a surgically implantable urethra pressure control valve and particularly to improvements thereof wherein the valve may be remotely operated or include a sphincter for operation by the user urging urine pressure thereagainst. 
       BACKGROUND ART 
       [0002]    In my co-pending U.S. application Ser. No. 11/775,259, entitled “Urethra Pressure Control Valve to Control Incontinence”, filed on Jul. 10, 2007, is described a surgical implantable urethra pressure control sphincter valve wherein an inflated balloon is retained captive inside a circumferential clamp which is disposed about the urethra in a patient&#39;s body whereby to close the urethra by applying a predetermined pressure thereto. The present invention relates to improvements in such pressure control sphincter valves. 
         [0003]    Urinary incontinence is defined as the accidental leakage of urine through the urethra. Prostate problems and post radical prostatectomy urinary incontinence greatly affects a male&#39;s 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. 
         [0004]    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. 
         [0005]    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. 
         [0006]    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. 
         [0007]    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&#39;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. 
         [0008]    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. 
         [0009]    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&#39;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. 
         [0010]    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. 
         [0011]    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. 
       SUMMARY OF INVENTION 
       [0012]    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. 
         [0013]    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. 
         [0014]    Another feature of the present invention is to provide a surgically implantable urethra pressure control adjustable sphincter valve, the closing pressure of which is adjustable by injecting fluid into a balloon retained in the valve through a conduit provided with a port connector located in the scrotum or elsewhere. 
         [0015]    Another feature of the present invention is to provide a surgically implantable urethra pressure control valve which is remotely operated by the use of a remote control device. 
         [0016]    Another feature of the present invention is to provide a surgically implantable urethra pressure control sphincter valve and wherein the clamp of the valve is provided by spaced-apart clamping formations which are formed by rigid wire-like members adapted to pinch the urethra. 
         [0017]    Another feature of the present invention is to provide a surgically implantable urethra pressure control valve and wherein at least the operating parts of the sphincter valve are secured in a sealed implantable housing. 
         [0018]    According to the above features, from a broad aspect, the present invention provides a surgically implantable urethra pressure control valve comprising a clamp having a pair of spaced apart clamping arms, a urethra passage defined between said clamping arms, at least one of said clamping arms being a displaceable clamping arm movable towards the other clamping arm to a predetermined position spaced from said other clamping arm a distance sufficient to pinch and close an inner passage of said urethra when disposed in said urethra passage to arrest the flow of urine, and actuating means to effect the displacement of said displaceable clamping arm. 
         [0019]    According to a still further broad aspect of the present invention there is provided a surgically implantable urethra pressure control sphincter valve comprising a clamp having a pair of spaced-apart clamping formations, a urethra passage defined between said clamping formations, one of said clamping formations being adapted to receive and position an inflatable balloon section of an implantable sphincter on one side of said urethra passage, said implantable sphincter having a flexile hydraulic tubing adapted to conduct hydraulic fluid sealingly injectable therein to inflate said balloon, the other of said clamping formations forming an abutment on an opposed side of said urethra passage whereby said urethra, when positioned in said urethra passage, will be pinched and closed between said balloon section when inflated and said abutment, said balloon being inflated to exert a predetermined pressure on said urethra to prevent the flow of urine from the bladder below said predetermined pressure. 
     
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0020]    A preferred embodiment of the present invention will now be described with reference to the accompanying drawings in which: 
           [0021]      FIG. 1  is a partly fragmented side view of a first embodiment of a surgically implantable urethra pressure control valve constructed in accordance with the present invention; 
           [0022]      FIG. 2A  is a front view of  FIG. 1 ; 
           [0023]      FIG. 2B  is a side view similar to  FIG. 1  but non-fragmented; 
           [0024]      FIG. 2C  is a front view similar to  FIG. 2A  but showing a urethra being compressed by an actuable clamping arm; 
           [0025]      FIG. 2D  is a front view similar to  FIG. 2C , but showing the urethra completely compressed by the displaceable clamping arm; 
           [0026]      FIG. 3  is a front view of the remote controller; 
           [0027]      FIG. 4  is a front view of a further embodiment of the surgically implantable urethra pressure control sphincter valve of the present invention, partly fragmented to show the actuating motor; 
           [0028]      FIG. 5  is a front view showing a urethra being compressed by the displaceable clamping arm actuated by the motor; 
           [0029]      FIG. 6  is a perspective view of a still further embodiment of the surgically implantable urethra pressure control sphincter valve of the present invention by the use resilient wire-like clamping formations; 
           [0030]      FIG. 7A  is an enlarged view of the wire clamp of  FIG. 6 ; 
           [0031]      FIGS. 7B and 7C  are perspective views showing the clamp being closed by the expansion of a sphincter controlled balloon; 
           [0032]      FIGS. 8A ,  8 B and  8 C are perspective views showing a still further embodiment of the surgically implantable urethra pressure control sphincter valve using a wire-like clamp having a different construction than that of  FIG. 6  and utilizing a sphincter controlled balloon as the actuating means; 
           [0033]      FIG. 8D  is a top view of  FIG. 8C  showing the positioning of the urethra with respect to the balloon and the clamp; 
           [0034]      FIGS. 9A to 9C  are perspective views illustrating a still further embodiment of the surgically implantable urethra pressure control sphincter valve of the present invention formed by the use of a wire-like clamping member and a sphincter balloon to close the urethra; and 
           [0035]      FIG. 9D  is a perspective view of the wire-like clamp. 
       
    
    
     DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0036]    Referring now to the drawings, and more particularly to  FIGS. 1 to 3 , there will be described the construction and operation of a first embodiment of the surgically implantable urethra pressure control valve  10 . The valve  10  comprises a clamp  11  formed by a pair of spaced-apart clamping arms, namely a stationary arm  12  and a displaceable arm  13 . A urethra passage  14  is defined between the clamping arms  12  and  13 . The urethra passage is dimensioned whereby to position therein the urethra  15  of a person in which the valve  10  is surgically implanted. 
         [0037]    The displaceable arm  13  has a connecting arm  16  which extends within a sealed implantable housing  17  formed of material suitable for implanting into the body of a person and is actuable on a pivot connection  18  of a stationary member  19  by an actuable solenoid rod  20  of a battery-operated solenoid  12 . A dc power cell  22  or battery operates the solenoid through electrical connections  23  and through a switch  24 . 
         [0038]    As shown in  FIGS. 1 to 2B , the clamp is in a normally open condition. This clamp is remotely operated by a remote-controlled hand-held device  24 , as shown in  FIG. 3 , which controls the switch  24 . By depressing the switch button  25 , the displaceable arm  13  is moved to its open position as shown in  FIGS. 1 to 2B . When the closed button  26  is depressed by the wearer of the device, the solenoid is operated thereby displacing the displaceable arm  13  to move towards the stationary arm  12  thus pinching a urethra  15  positioned in the urethra passage  14  in a fashion as illustrated by  FIGS. 2C and 2D . Accordingly, when the wearer person has an urge to release urine from the bladder, he simply operates the remote controller to open the urethra and discharge the bladder. Although not shown in  FIG. 1 , a suitable receiver circuit  27 , details of which are not shown, is provided to receive the signal from the remote controller to operate the switch whereby to connect power to the solenoid. 
         [0039]    Referring now to  FIGS. 4 and 5 , there will be described a still further embodiment of the surgically implantable urethra pressure control valve  30  of the present invention. As hereinshown, the actuating means is a battery-operated electric motor  31  which is immovably secured within the housing  17 . The motor has an actuable shaft  32  which is coupled to the displaceable clamping arm  33  to displace the clamping arm from a urethra “open” position to a urethra “close” position, as previously described. A power cell or battery  34  operates the electric motor  31  through a switch  35 . Again, a suitable receiver circuit is provided to receive the command signal from the remote controller  24  as shown in  FIG. 3 . As shown in  FIG. 5 , the clamping arm  33  is coupled to the actuating shaft  32  of the electric motor and is displaced in a similar fashion as described with respect to the embodiment of  FIGS. 1 to 2D . 
         [0040]    Referring now to  FIGS. 6 to 7C , there will be described another embodiment of the surgically implantable urethra pressure control valve  40  of the present invention incorporating a control sphincter. As hereinshown, the valve is constructed by a wire-like formation formed of a rigid spring stainless steel wire or suitable clinically approved rigid plastics material having a memory capable of retaining its shape and defining a pair of spaced-apart clamping arms and  42 . The shaped wire member  43  further defines actuating formations  44  and  45  in a free end of the wire-like clamp  43 . These actuating formations are circular loops formed in the spaced free ends of the wire-like clamp formation  43 . 
         [0041]    A urethra passage  46  is defined between the clamping arms  41  and  42 . As shown more clearly in  FIG. 7A , the clamping arm  42  has an inner projecting pinching formation  47  which is hereinshown as a narrow projecting formation but it could be much wider than that as hereinshown. The urethra passage  46  is defined under this pinching formation  47 .  FIGS. 6 and 7A  show the clamp in a normal position. Although not shown, this clamp may be housed in a surgically implantable pouch having passages to receive the urethra  15  therethrough and a free end of an inflatable balloon section  48  of an implantable sphincter having an inflatable balloon  49  adjacent a free end  50  of section  48  with the balloon  49  being located between the loops of the actuating formations  44  and  45  and this is more clearly shown in  FIGS. 7B and 7C . The implantable sphincter has a flexible hydraulic tube  51  to conduct hydraulic fluid which is sealingly injectable therein by a syringe to inflate the balloon  49  to a controlled size as shown in  FIG. 7C . As shown in  FIGS. 7B and 7C , by inflating the balloon to a controlled size, the actuating formations  44  and  45  are caused to move away from one another thereby causing the clamping arms  41  and  42  to move closer to one another to effect the pinching and closing of the urethra  15  positioned in the urethra passage  46 . This pinching pressure is predetermined whereby the urethra can open upon pressure built-up by the urine accumulation in the bladder causing the user to exercise a need to evacuate urine. 
         [0042]    Referring now to  FIGS. 8A to 8D , there will be described a still further embodiment of the surgically implantable urethra pressure control sphincter valve  55  of the present invention. As hereinshown the clamp is constituted by a rigid wire-like member  56  constructed with suitable material as previously described, and shaped to define spaced-apart clamping formations. The wire-like member  56  defines a cage formed by opposed parallel rectangular restraining side formations  57  and  58  which define therebetween a restricted longitudinal open-ended passage  59  to receive and retain the free end section  48  of the sphincter as previously described with respect to  FIG. 6  and including the inflatable balloon. The opposed parallel rectangular restraining side formations  57  and  58  have an inwardly angled top and bottom wire section  57 ′ and  58 ′ to form top and bottom wire restraining formations  60  and  60 ′. The top wire restraining formation  60  constitutes an abutment against which the urethra  15  is pinched and it may have suitable cushioning members  61  secured to the wire-like members in the area of the inwardly angled portion  58 ′ to abut against the urethra. As shown in  FIG. 8A , the free end section  48  of the sphincter containing the balloon is in its operating position. 
         [0043]    Referring now to  FIGS. 8B and 8C , there is shown the operation of the valve. As previously described, when hydraulic fluid is sealingly injected into the sphincter tubing  51 , the balloon  49  inflates. Because the urethra  15  is disposed between the balloon and the abutment  60 , when the balloon increases in size, it closes the urethra by pinching the urethra between the cushions  61  and the balloon  49  effecting a closure. The pressure applied is a control pressure which is sufficient to cause the pressure of the fluid in the bladder to open the urethra when the user exercises a need to evacuate fluid thereby causing the clamp section of the spring to flex or causing the balloon to deform causing an opening of the urethra sufficient to evacuate urine. 
         [0044]    Referring now to  FIGS. 9A to 9D , there is described another embodiment of the surgically implantable urethra pressure control sphincter valve  70  of the present invention. As hereinshown the clamp  71  is also formed of either stainless steel wire or a wire-like member formed from a clinically certified synthetic material capable of being molded and having a memory to retain its shape. It is also shaped to define the spaced-apart clamping formations herein constituted by a straight wire end section  72  which defines one clamping formation, and a U-shaped right-angled formation which defines a balloon nesting section  73 . The balloon nesting section  73  is defined by the U-shaped wire end portion  74 . The clamp  71  is also shaped whereby to define a sphincter passage  75  between opposed transverse arms  76  of the U-shaped right-angle formation. The urethra passage  77 , as better shown in  FIG. 9D , extends between the balloon nesting section  73  and the straight wire end section  72  and extending transversely to the straight wire section. 
         [0045]    As shown in  FIG. 9D , the straight wire end section  72  may also have an upwardly extending free end section  78  as shown in stippled lines and projecting towards the nesting section  73  whereby to better restrain the urethra  15  in position in the urethra passage  77 . 
         [0046]    As shown in  FIGS. 9B and 9C , by inflating the balloon  49  of the sphincter, control pressure is applied against the urethra  15  to close the urethra. Evacuation of urine is effected in the same fashion as previously described with reference to  FIGS. 6 to 8D . 
         [0047]    It is also contemplated that the battery for the devices be accessible outside the skin of the wearer person and connected by an implanted wire. This permits for the recharging or replacement of the battery. The battery could be protected by a waterproof adhesive tape, a waste band, etc. 
         [0048]    It is within the ambit of the present invention to cover any obvious modifications of the preferred embodiments described herein, provided such modifications fall within the scope of the appended claims.