Patent Publication Number: US-2016220341-A1

Title: Hydraulic urethral occlusive device

Description:
This invention was made with government support under SBIR Grant Number R43 DK092007-01 awarded by the National Institutes of Health. The government has certain rights in the invention. 
    
    
     FIELD 
     The disclosure herein relates to embodiments of hydraulic urethral occlusive devices (HUOD) that are entirely inserted or surgically implanted within the body for controlling the lack of urinary or bowel restraint. These devices are commonly referred to as “artificial sphincters” which are installed within the body to aid or replace the body&#39;s natural sphincter. 
     BACKGROUND 
     One such device by American Medical Systems, Inc. is the AUS 800, which is a totally implantable hydraulic sphincter implanted in both males and females experiencing urinary incontinence and has been on the market for over 35 years. The AUS 800 and its predecessors are described in U.S. Pat. Nos. 3,863,622; 4,222,377; 4,412,530; and 4,878,889. The AUS 800 consists of a silicone pressure regulating balloon implanted in the prevesical space, a silicone control pump implanted in the scrotum or labia, and a silicone urethral occlusive cuff wrapped around the bulbous urethra in males or bladder neck in females. Each component is filled with saline or radiopaque contrast media. Tubing, emanating from each component, is routed between incisions and appropriate connections are made. The device is deactivated for a period of approximately 6 weeks to allow tissue healing to proceed and urethral edema to subside. At activation, the control pump is squeezed sharply to unseat a poppet and open operational fluid flow paths. The patient is taught to operate the device by squeezing the control pump through the scrotal or labial skin. This action transfers fluid from the cuff to the pressure regulating balloon. The balloon forces the fluid through a fluid restrictor and back into the cuff to reestablish an occlusive urethral pressure within 3-5 minutes. The AUS 800 is complicated to implant, is prone to fluid leakage, and causes urethral atrophy and erosion. Despite these draw backs, the AMS 800 remains a limited commercially available option for artificial urinary sphincters. 
     Another such type of mechanical artificial urinary sphincter, the Timm-AUS, is described in U.S. Pat. Nos. 5,704,893 and 6,074,341, both of which are entitled VESSEL OCCLUSIVE APPARATUS AND METHOD. The Timm-AUS is a one piece device not requiring saline filling or intra-operative assembly. Depression of a deactivation button through the scrotal skin causes a urethral occlusive sheath to expand and remove occlusive pressure from the urethra to allow normal urination. Depression of an activation button allows the occlusive sheath to contract and reapply urethral pressure to prevent urethral leakage. Human implantation experience with the Timm-AUS was hindered by formation of a tough, fibrous capsule surrounding the device which prevented expansion of the occlusive sheath. 
     Another mechanical method of occluding the urethra is demonstrated by U.S. Pat. No. 8,007,429 A1 entitled VESSEL OCCLUSIVE DEVICE AND METHOD FOR OCCLUDING A VESSEL. In this patent, depression of an activation button allows a constant force spring to apply tension to a compressible tape wrapped circumferentially about the urethra. In so doing, urinary leakage is prevented. Depressing a deactivation button removes spring tension and urethral compression to allow unobstructed urinary voiding. 
     A hybrid mechanical/hydraulic artificial urethral sphincter is described in US patent application publication 2010/0211175 A1 SURGICAL IMPLANT, IN PARTICULAR ARTIFICIAL SPHINCTER WITH ADJUSTED PRESSURE. This patent application publication describes a helical spring biased piston which maintains hydraulic pressure within an inflatable cuff circumferentially disposed about the urethral circumference. Depression of a secondary hydraulic bladder forces fluid from the piston into a third holding bladder to remove hydraulic pressure from the urethra. The pressurized fluid within this third bladder is then slowly discharged back into the piston through a fluid restrictor to re-establish hydraulic pressure about the urethra. Pressurized fluid may be locked out of the hydraulic cuff to remove pressure for a prolonged period as might be required immediately following implantation and during sleep when urinary leakage is not as problematic. Lockout is accomplished by depressing a lockout button. Returning the device to its normal function is accomplished by depressing the lockout button on its opposite side. 
     As evidenced by clinical experience with the above devices, it is difficult to teach the patient to identify and then operate the small lockout valve which is encased within and masked by scrotal tissues. Additionally, cuff refilling through the fluid restrictor takes 3 to 5 minutes. This allows ample time for the patient to believe that his bladder is empty and leave the commode. Residual urine within the bladder may then leak through the uncompressed urethra to wet the patient&#39;s clothing. 
     SUMMARY 
     A hydraulic urethral occlusive device (HUOD) is described herein that is an implantable artificial urinary sphincter intended to provide the incontinent patient protection against urine leakage and “at will” control over his/her voiding function. The HUOD is intended to address the drawbacks of the state of the art by providing several features described herein and illustrated in the drawings. 
    
    
     
       DRAWINGS 
       These and other features, aspects, and advantages of the hydraulic urethral occlusive device will become better understood when the following detailed description is read with reference to the accompanying drawing, wherein: 
         FIG. 1  is a perspective view of a hydraulic urethral occlusive device according to one embodiment, and shown with one embodiment of an occlusive cuff not encircling a urethra. 
         FIG. 2  is a perspective view of the occlusive cuff alone from the hydraulic urethral occlusive device of  FIG. 1 , shown in a flat condition. 
         FIG. 3  is perspective view of the occlusive cuff alone from the hydraulic urethral occlusive device of  FIG. 1 , shown encircling a urethra. 
         FIG. 4A  is a side view of the occlusive cuff alone from the hydraulic urethral occlusive device of  FIG. 1 , shown sized around a relatively smaller urethra.  FIG. 4B  is a side view of the occlusive cuff alone from the hydraulic urethral occlusive device of  FIG. 1 , shown sized around a relatively larger urethra. 
         FIG. 5A  is a frontal sectional view of a pressure compensator of the hydraulic urethral occlusive device of  FIG. 1 , according to one embodiment, and shown in a state when the hydraulic urethral occlusive device is off, unpressurized.  FIG. 5B  is a lateral sectional view of the pressure compensator of  FIG. 5A  in the state when the hydraulic urethral occlusive device is off, unpressurized.  FIG. 5C  is a frontal sectional view of the pressure compensator of  FIG. 5A , and shown in a state when the device is on, pressurized.  FIG. 5D  is a lateral sectional view of the pressure compensator of  FIG. 5A  in the state when the hydraulic urethral occlusive device is on, pressurized. 
         FIG. 6A  is a side view of a control mechanism of the hydraulic urethral occlusive device of  FIG. 1 , according to one embodiment, and shown in a state when the hydraulic urethral occlusive device is activated.  FIG. 6B  is another side view of the control mechanism of the hydraulic urethral occlusive device of  FIG. 6A , and shown in a state when the hydraulic urethral occlusive device is deactivated. 
         FIG. 7A  is a side sectional view of the control mechanism of  FIG. 6A , shown in the activated state.  FIG. 7B  is a side sectional view of the control mechanism of  FIG. 6A , shown moving to the deactivated state.  FIG. 7C  is a side sectional view of the control mechanism of  FIG. 6A , shown in the deactivated state. 
         FIG. 8  is diagrammatic view of a hydraulic urethral occlusive device, according to another embodiment, in which the control mechanism is an electro-mechanical control mechanism. 
         FIG. 9  is a perspective view of another embodiment of an occlusive cuff not encircling a urethra and shown in a flat condition. 
         FIG. 10A  is a partial view showing the occlusive cuff of  FIG. 9  shown encircling a urethra but not in the fully clipped position. 
         FIG. 10B  is a partial view showing the occlusive cuff of  FIG. 9  shown encircling a urethra in the fully clipped position. 
         FIG. 11  is a schematic view of one embodiment of a hydraulic urethral occlusive device implanted in a human male subject. 
         FIGS. 12A to 12D  show views of another embodiment of a pressure compensator with a hollow shell, which may be flexible and which may be resilient.  FIG. 12A  is a frontal sectional view of the pressure compensator shown in a state when the hydraulic urethral occlusive device is off, unpressurized.  FIG. 12B  is a lateral sectional view of the pressure compensator of  FIG. 12A  in the state when the hydraulic urethral occlusive device is off, unpressurized.  FIG. 12C  is a frontal sectional view of the pressure compensator of  FIG. 12A , and shown in a state when the device is on, pressurized.  FIG. 12D  is a lateral sectional view of the pressure compensator of  FIG. 12A  in the state when the hydraulic urethral occlusive device is on, pressurized. 
         FIGS. 13A and 13B  show embodiments of a hydraulic urethral occlusive device implanted in a human male subject, and which may implement the pressure compensator of  FIGS. 12A to 12D .  FIG. 13A  shows the pressure compensator placed in a subcutaneous location, such as in the abdominal subcutaneous tissue.  FIG. 13B  shows the pressure compensator placed in a pre-vesical space, such as between the bladder and the pubic bone. 
         FIG. 14  shows one embodiment of post-implantation adjustment, such as by retrograde perfusion, to for example increase or decrease occlusive pressure. 
         FIG. 15A  shows one embodiment of a re-pressurization device, which may be used during a post-implant adjustment and shown with a hydraulic urethral occlusive device. 
         FIG. 15B  shows one embodiment of a pressure transducer of the re-pressurization device of  FIG. 15A . 
     
    
    
     While the above-identified figures set forth particular embodiments of the hydraulic urethral occlusive device, other embodiments are also contemplated, as noted in the discussion. In all cases, this disclosure presents illustrated embodiments of the hydraulic urethral occlusive device by way of representation but not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of the systems and methods described herein. 
     DETAILED DESCRIPTION 
     A hydraulic urethral occlusive device (HUOD)  1 , as depicted for implantation in males is illustrated in  FIG. 1 . The hydraulic urethral occlusive device is a one-piece device implanted through a single perineal or peno-scrotal incision. An inflatable hydraulic occlusive cuff  2  encircles the urethra and is permanently attached via a flexible tube to the control mechanism  3  implanted in the scrotum. A pressure compensator  4  is likewise permanently attached to the control mechanism  3  via a flexible conduit  10  to allow placement in the subcutaneous tissues of the abdomen, thigh or alternately in the pre-vesical space. The occlusive cuff  2  is implanted in an uninflated, deactivated condition for approximately 6 weeks post-operatively to facilitate healing and allow pain and edema to subside. Following this deactivation period, the urologist activates the device by depressing an activation button  5  through the intact scrotal skin. In so doing, the occlusive cuff  2  inflates to apply a preset occlusive pressure within the range of 60-80 cm H 2 O to the urethra. The patient is then free to depress a deactivation button  6  to evacuate hydraulic fluid from the occlusive cuff  2  and allow unobstructed voiding. To re-establish urethral occlusive pressure and continence, the patient pushes the activation button  5 . 
     The control mechanism  3  is encapsulated by a silicone boot  7  which incorporates a needle port or septum  8 . All other HUOD components likewise can be encapsulated by silicone rubber coverings to prevent hydraulic solution leakage and the incursion of bodily fluids. The control mechanism  3  is in fluid communication with the occlusive cuff  2  and the inner portion of the pressure compensator  4 . The inner portion of the pressure compensator  4  is further surrounded by an outer pressure capacitor chamber containing a second and separate fluid volume. This chamber also incorporates a needle puncture port or septum  9 . Each separate fluid volume defined by the above-mentioned structures may be filled by accessing each septum  8  and  9  with a hypodermic needle and infusing appropriate filling solutions. The pressure compensator  4  and control mechanism  3  are joined by the flexible conduit  10 . 
     The first fluid volume contained within the control mechanism  3 , occlusive cuff  2 , and the inner portion of the pressure compensator  4  is filled with normal saline or radiopaque solutions intended to allow visualization of these otherwise, non-radiopaque structures. The outer pressure capacitor chamber is filled with normal saline only, so as not to obscure radiographic visualization of the inner portion of the pressure compensator  4 . 
     The occlusive cuff  2  may be adjusted to accommodate varying urethral circumferences as might be found in the human population. The urethral circumference may first be measured with a flexible measuring tape. The cuff  2  is then wrapped around the urethra and locked into a detent corresponding to the measured urethral circumference. 
     The hydraulic urethral occlusive device is also configurable for female implantation through a transvaginal or abdominal incision. In this case, the occlusive cuff  2  would encircle the bladder neck or mid-urethra. The control mechanism  3  for female implantation would be miniaturized for implantation in the labia or abdominal skin where it could be operated by manual depression activation and deactivation buttons  5 ,  6 , through the labial or abdominal tissue. The pressure compensator  4  may be implanted in similar locations described for male implantation. The control mechanism  3  may also be replaced with a motor driven servo which would alternately apply or remove tension from the pressure compensator causing it to apply or remove pressure from the cuff  2  (see e.g. embodiment of  FIG. 8  further described below). The addition of implantable pressure transducing elements and a closed-loop control system would allow this device to respond in real-time to increases in bladder and, or intra-abdominal pressures which may cause the patient to leak urine (see e.g. embodiment of  FIG. 8  further described below). 
     Advantages over the current state of the art can include, for example: 
     no intra-operative assembly required; 
     no tubing connectors which are prone to disconnection; 
     allows post-implantation re-pressurization to allow degree of continence to be incrementally improved; 
     single incision implantation with reduced surgical morbidity; 
     a “one size fits all” cuff design which eliminates the need for a hospital to stock devices in a multitude of sizes which are then selected at the time of surgery; 
     greatly reduced operative time as evidenced by human implants with predecessor device; 
     large buttons which are easily identifiable and operable by both physician and patient without the need for a separate deactivation button; and 
     no time delay when changed from the deactivated to activated conditions to reduce unexpected urinary leakage. 
     The hydraulic urethral occlusive device also has applications in the areas of fecal incontinence, gastro-esophageal reflux disease (GERD), and gastric banding for weight loss. Other disease states which may be served by occlusion or support of tubular body passages may lend further usage to the HUOD concept. 
     As described above, the hydraulic urethral occlusive device is a totally implantable artificial urinary sphincter intended to prevent urinary leakage in both males and females. Men frequently become incontinent of urine following surgeries to remove cancerous prostates. Women are often rendered incontinent due to the pelvic trauma caused during childbirth and due to a laxity of the pelvic muscles occurring due to aging. To a lesser degree, men and women are rendered incontinent due to trauma, infection and birth defects. The American Medical Systems, Inc. AUS 800 is a limited but commercially available, totally implantable artificial urinary sphincter. The complexity of its implantation is due to the requirement to intra-operatively fill and assemble its three components. The AUS 800 often fails due to wear in its componentry which leads to fluid leakage and post-operative infections. Urethral atrophy and erosion sometimes occur and are suspected to be due to the crenate shape of its occlusive cuff. The AUS 800 is available with a number of occlusive pressure ranges with 61-70 cm H 2 O being the pressure most frequently selected. 
     Referring back to  FIG. 1 , the hydraulic urethral occlusive device  1  is a one-pieced device not requiring assembly. The hydraulic urethral occlusive device  1  may be filled with saline solution, or a combination of saline solution and radiopaque dyes intended to aid in visualization of anatomical placement and functionality. The hydraulic urethral occlusive device has the occlusive cuff  2  to surround the urethra or bladder neck and has the control mechanism  3 , which is implanted in the scrotum in males and the labia or abdominal wall in females. The pressure compensator  4  is joined to the control mechanism  3  by the conduit  10  through which tensioning cables pass (see e.g.  FIGS. 5A through 5D ). The conduit  10  is flexible to accommodate bodily movement by the human implant subject. 
     Occlusive Cuff 
     Further details of the occlusive cuff  2  are shown in  FIGS. 2-4 .  FIG. 2  shows the occlusive cuff  2  in its flat condition prior to implantation and in its condition when it could encircle a urethra  13  in  FIGS. 3 and 4 . The occlusive cuff has a thin-walled, expandable pouch  11  to which is affixed a semi-flexible cuff backing strip  12  as shown in  FIG. 2 . When encircling the urethra  13  (see e.g.  FIGS. 4A and 4B ), the fluid-tight expandable pouch  11  may be alternately expanded or deflated by infusion of a suitable filling media such as isotonic saline or radiopaque contrast media. Inflation occurs through a flexible input tube  14 , such as indicated in  FIG. 3 . The occlusive cuff  2  with the expandable pouch  11  inflated is also shown in  FIG. 3 . When the expandable pouch  11  is inflated, the pressure exerted on the urethra  13  is sufficient to prevent or minimize urinary leakage. Historical clinical evidence suggests that this pressure should be in the range of 60-80 cm H 2 O to provide adequate leak resistance without causing undue urethral atrophy or tissue erosion. When the expandable pouch  11  is deflated, pressure is removed from the urethra  13  to allow normal, unobstructed urinary drainage. The cuff backing strip  12  is positioned on the expandable pouch  11  surface away from the urethral surface and acts to maximize urethral occlusion efficiency by minimizing radial expansion of the expandable pouch  11  away from the urethra  13 . Sizing detents  15  are positioned on the cuff backing strip  12  to allow the occlusive cuff  2  to be sized to accommodate anatomical variations in urethral circumferences as may occur in the human population as shown in  FIGS. 4B and 4B . Clinical experience indicates that the range of urethral circumferences in the human male population ranges from 3.5 cm to 5.0 cm. Sizing indicators  16  may be associated with the detents  15  to provide the surgeon with urethral circumference information. When the occlusive cuff  2  is surgically wrapped around the urethra  13 , the free end of the occlusive cuff  2  is inserted through a locking clip  17  and advanced to the detent  15  to provide a close fit between the occlusive cuff  2  and urethra  13 . 
       FIGS. 9 and 10A to 10B  show another embodiment of retaining and/or locking the occlusive cuff in place, which is further described below. 
     The expandable pouch  11  may be constructed using an inner substrate of expanded polytetrafluoroethylene (ePTFE). The substrate may be in tubular form, sealed at either end to form a leak-proof pouch. The flat width of the tubular expandable pouch  11  may be within the range of 1 cm to 3 cm and ePTFE materials with a wall thickness of 0.003″-0.005″ and an internodal distance (porosity) of 30μ-50μ have been shown to have an appropriate flexibility. The substrate is rendered leak-proof by application of a thin coat of silicone rubber applied by a dispersion dip molding process. The ePTFE porosity range indicated above, allows deposition of silicone dispersion into the porous interstices to create a bond between the silicone outer layer and the ePTFE substrate. Wear and subsequent filling media leakage is minimized by applying low coefficient of friction coatings to the opposing outer silicone surfaces. These coatings include polytetrafluoroethylene (PTFE) particulate over-sprays or NuSil MED 6670 or NuSil MED 6671 silicone dispersions. Wear created by relative movement of opposing surfaces on the inner of the expandable pouch  11  surfaces is minimized by the low coefficient of friction nature of the ePTFE substrate. 
     Alternately, the expandable pouch  11  may be entirely manufactured from silicone using a dispersion casting or molding method. To reduce the tendency of wear induced holes in the expandable pouch  11 , polytetrafluoroethylene (PTFE) particulate over-sprays or NuSil MED 6670 or NuSil MED 6671 silicone dispersions may be used as coatings on the inner and outer surfaces of the expandable pouch  11 . 
     Pressure Compensator 
     In  FIGS. 5A to 5D , the pressure compensator  4  is a structure attached to the control mechanism  3  via a flexible conduit tube  18 ,  10 . A tension cord  19  travels from the control mechanism  3  through the conduit tube  18  to the apex of the pressure compensator diaphragm  20 . The pressure compensator diaphragm  20  is a thin-walled, bullet-shaped diaphragm which operates between an expanded and collapsed condition. Tension applied to the tension cord  19  by the control mechanism  3  collapses the pressure compensator diaphragm  20 , and pressurizes the filling media contained within it (see e.g.  FIGS. 5B and 5C ). This filling media volume is then transferred to the occlusive cuff  2  which inflates to occlude the urethra. The pressure generated within the pressure compensator diaphragm  20  is determined by its cross-sectional area and the force applied to the tension cord  19  according to the equation: 
       Pressure=Force/Cross-sectional Area 
     When tension is released from the tension cord  19 , the resilience of the compressed urethral tissue forces filling media out of the occlusive cuff  2  and re-expands the pressure compensator diaphragm  20  to the position shown in  FIGS. 5A and 5B . 
     The pressure compensator diaphragm  20  is contained within a semi-rigid compensator shell  21  which prevents surrounding bodily tissue from collapsing around and applying unintended pressure to the pressure compensator diaphragm  20 . A fluid volume  22  contained within the compensator shell  21  surrounds and is separated from the filling media volume  23  contained within the pressure compensator diaphragm  20 . As the pressure compensator diaphragm  20  collapses and filling media is transferred to the occlusive cuff  2 , an equal volume of fluid is transferred into the compensator shell  21 . This fluid transfer prevents a vacuum from forming within the compensator shell  21  which might prevent proper collapse of the pressure compensator diaphragm  20 . Fluid transfer to the compensator shell  21  is facilitated by the collapse of a flexible compensator dome  24  on the outer surface of the compensator shell  21  as shown in  FIGS. 5C and 5D . Expansion of the pressure compensator diaphragm  20  causes fluid transfer from the compensator shell  21  and re-expansion of the compensator dome  24  as shown in  FIGS. 5A and 5B . At the time of surgical implantation, the compensator shell  21  is filled with an isotonic filling solution such as normal saline via a needle inserted into the septum  9 . 
     The pressure compensator  4  components may all be manufactured from silicone rubber. Wear between opposing surfaces of the pressure compensator diaphragm  20  may be minimized using the low-coefficient of friction surface treatment described above for the occlusive cuff  2 . 
     Control Mechanism 
     Tension applied to the pressure compensator diaphragm  20  is supplied by a control mechanism  3  implanted in the scrotum of the male or in the abdominal wall of the female or in a miniaturized version within the labia of the female. See e.g.  FIGS. 6A to 7C . Depression of an activation button  25  (e.g.  5 ) on the control mechanism  3  through the intact skin causes a spring force to retract the pressure compensator diaphragm  20  and apply a constant pressure to the urethra  13  which it encircles. Depression of a deactivation button  26  (e.g.  6 ) also located on the control mechanism  3 , releases the spring force from the pressure compensator diaphragm  20  and removes pressure from the urethra  13 . 
     Embodiments of various control mechanisms are described in great detail in U.S. Pat. No. 8,007,429 B2 VESSEL OCCLUSIVE DEVICE AND METHOD FOR OCCLUDING A VESSEL. One of these embodiments is further described in below. 
     Pulley  27  counter-rotation is accomplished when the user depresses the deactivation button  26  exiting the control mechanism  3 . A cable  28  wraps around the small pulley  29  at one end and the radiused base of the deactivation button  26  at its other end as shown in  FIGS. 6A and 6B . As the deactivation button  26  advances, the distance the cable  28  is pulled, is magnified relative to the distance the deactivation button  26  is depressed. 
     When the deactivation button  26  is depressed to its full extent, a détente pin  30  contained within the deactivation button  26  engages a lever  31 , which prevents the deactivation button  26  from returning to its original extended position as shown in  FIG. 7A-7C . The lever  31  is biased by a spring  32  captured between the lever  31  and a silicone rubber boot  7  (see e.g.  FIG. 1 ) surrounding the control mechanism  3 . As the deactivation button  26  is depressed, the deactivation button dome  33  of the flexible silicone boot  7  deforms with the force applied to it, but rebounds to its original shape when the force is removed. In this way, the occlusive cuff  2  is held in a condition which does not compress the urethra. Rebounding of the deactivation button dome  33  prevents tissue capsule formation, which normally forms around implanted devices over time, restricting movement of the deactivation button  26 . 
     When the patient desires to return to a continent state with the urethra  13  compressed, the silicone boot  7  is depressed over the lever  31  as shown in  FIG. 7C . See e.g. arrow, activation button  25  in  FIG. 7C . This disengages the lever  31  from the détente pin  30 , allowing the deactivation button  26  to return to an extended position under the bias of a constant force spring  34  nested within the pulley  27 . 
       FIG. 11  is a schematic view of one embodiment of a hydraulic urethral occlusive device implanted in a human male subject. In particular,  FIG. 11  shows the anatomical placement for example of the hydraulic urethral occlusive device  10  including the occlusive cuff  2 , the control mechanism  3 , and the pressure compensator  4 . It will be appreciated that any of the hydraulic urethral occlusive devices described herein, including their accompanying components such as the occlusive cuff, pressure compensator, control mechanism, and conduit tubes, may be similarly implanted as shown in  FIG. 11 . Placement of the pressure compensator  4  may be made in the abdominal subcutaneous tissue, tissue of the thigh or in the pre-vesical space between the urinary bladder and pubic bone.  FIG. 11  shows the pressure compensator  4  placed in the abdominal subcutaneous tissue. As described above, increases in intra-abdominal pressure can be transferred hydrostatically to the bladder and, when the bladder pressure exceeds the urethral closure pressure, urinary leakage occurs. Increases in intra-abdominal pressure may be caused by stressful events such as for example, sneezing, coughing, or laughing. Pressurization of the occlusive cuff  2  to occlude the urethra occurs when the diaphragm inside the pressure compensator  4  collapses under the influence of the tension cord, e.g.  19 , attached to the tensioning mechanism contained within the control mechanism  3 . The control mechanism  3  can establish for example about 60-80 cm H 2 O of urethral occlusive pressure when the control mechanism  3  is in the activated condition. The urethral occlusive pressure range can minimize urinary leakage in the situations where the natural urinary sphincter has been damaged by disease or trauma. 
       FIGS. 12A to 12D  show views of another embodiment of a pressure compensator  400  with a hollow shell  421 , which may be flexible and which may be resilient. It will be appreciated that the pressure compensator  400  may be implemented with any of the control mechanisms and occlusive cuffs described herein, and for purposes of discussion the pressure compensator  400  is described with respect to the control mechanism  3  and occlusive cuff  2  of  FIG. 1  or  FIG. 11 . 
     In  FIGS. 12A to 12D , the pressure compensator  400  is a structure that may be attached to control mechanism  3  via a flexible conduit tube  418 ,  10 . A tension cord  419  travels from the control mechanism  3  through the conduit tube  418  to the apex of the pressure compensator diaphragm  420 . The pressure compensator diaphragm  420  can be a thin-walled, bullet-shaped diaphragm which operates between an expanded and collapsed condition. Tension applied to the tension cord  419  by the control mechanism  3  collapses the pressure compensator diaphragm  420 , and pressurizes the filling media contained within the filling media volume  423  (see e.g.  FIGS. 12B to 12C ). The fluid in the filling media volume  423  is then transferred to the occlusive cuff  2  which inflates to occlude the urethra. As the diaphragm  420  collapses, the flexible wall of the shell  421  can also collapse some in response to vacuum created within the fluid volume  422 . 
     The pressure generated within the pressure compensator diaphragm  420  can be determined by its cross-sectional area and the force applied to the tension cord  19  according to the equation: 
       Pressure=Force/Cross-sectional Area 
     When tension is released from the tension cord  419 , the resilience of the compressed urethral tissue forces filling media out of the occlusive cuff  2  and re-expands the pressure compensator diaphragm  420  to the position shown in  FIGS. 12A and 12B . 
     The pressure compensator diaphragm  420  is contained within a compensator shell  421  which may be of a flexible material that is compatible for implantation, and which may be resilient. The fluid volume  422  is contained within the compensator shell  421 . The fluid volume  422  surrounds and is separated from the filling media volume  423  contained within the pressure compensator diaphragm  420 . The pressure compensator can also include infusion ports  426 ,  428  for the fluid volume  422  and filling media volume  423 , respectively. 
     In the embodiment of  FIGS. 12A to 12D , the compensator shell  421  surrounding the pressure compensator diaphragm  420  may also be externally compressed to provide a greater pressure within the pressure compensator diaphragm  420 , such as for example pressures higher than the 60-80 cm H 2 O as described above. In some embodiments, the increased pressure may be within the range of about 80-200 cm H 2 O. Such pressures may be useful and suitable to prevent urinary leakage during even more stressful events. In  FIGS. 12A to 12D , there are no obstructions in the hydraulic flow paths between the pressure compensator  400 , control mechanism  3  and occlusive cuff  2 . Pressure increases within the pressure compensator  400  can be directly transferred to the occlusive cuff. When external pressure is removed from the pressure compensator  4 , the occlusive pressure can return to its usual, e.g. resting, pressure for example at about 60 to 80 cm H 2 O. 
     In contrast to the semi-rigid pressure compensator  4  above, the pressure compensator  400  may be constructed as a hollow-shelled, flexible structure to sometimes facilitate additional hydraulic pressure transfer from the pressure compensator to the occlusive cuff. 
     In some embodiments, the compensator shell  421 , diaphragm  420 , diaphragm mount, control mechanism outer covering (e.g. boot), occlusive cuff components are silicone or a similar material. In some embodiments, the conduit tube  10 ,  418  (e.g. from the pressure compensator  400  to control mechanism  3 ) has an outer silicone layer, a central metal coil, and an inner expanded polytetrafluoroethylene (ePTFE) layer. In some embodiments, the conduit tube between the occlusive cuff and the control mechanism is silicone. In some embodiments, the tension cord  419  is a polytetrafluoroethylene material such as a Teflon® coated polyester. In some embodiments, inner components of the control mechanism  3  may be constructed using a mixture of titanium, stainless steel, and ultra-high molecular weight polyethylene. 
       FIGS. 13A and 13B  show embodiments of a hydraulic urethral occlusive device implanted in a human male subject, and which may implement the pressure compensator  400  (shown schematically) of  FIGS. 12A to 12D . It will be appreciated that any of the hydraulic urethral occlusive devices described herein, including their accompanying components such as the occlusive cuff, pressure compensator, control mechanism, and conduit tubes, may be similarly implanted as shown in  FIGS. 13A and 13B . 
       FIG. 13A  shows the pressure compensator  400  placed in a subcutaneous location, such as in the abdominal subcutaneous tissue. Pressure compensator placement in the abdominal subcutaneous tissue can allow the subject or patient to manually compress the pressure compensator  400  through the abdominal skin. In so doing, the urethral closure pressure can be increased above the baseline pressure of, for example 60-80 cm H 2 O, and can be increased such as for example in anticipation of particularly stressful events such as sneezing, coughing, or laughing. Removal of this manual compression allows a return to the normal resting urethral pressure, e.g. above the baseline pressure such as about 60-80 cm H 2 O. 
       FIG. 13B  shows the pressure compensator  400  placed in a pre-vesical space, such as between the pubic bone  402  and the bladder  404 . Pressure compensator placement in the pre-vesical space between the bladder  404  and pubic bone  402  can allow bladder pressure increases to be transmitted to the pressure compensator  400  in real-time. In so doing, the occlusive cuff  2  could respond automatically to increases in abdominal pressure without manual intervention, such as in  FIG. 13A . 
     The use of the pressure compensator  400  with a hollow flexible shell, e.g.  421 , can allow for transfer of hydraulic pressure directly to the cuff, where the filling volume  423  and fluid volume  422  can be constructed and arranged for example as a reservoir within a reservoir configuration. The placement for example in a pre-vesical space can allow for a real time response to increases in bladder pressure, such as for example above a baseline occlusive pressure. 
     Post-Implantation Refilling/Repressurization 
     From clinical history with other commercially available artificial urinary sphincters (AUS), it is noted that post-implantation pressures applied to the urethra are frequently inadequate to provide improved continence. In these cases, the only recourse is for the patient to use other means to manage their incontinence, or to have the implanted AUS removed and replaced with one of a higher pressure. Increased risk of surgical mortality and morbidity exists with any additional surgical intervention. 
     If patients implanted with the hydraulic urethral occlusive device continue to leak urine, the device may be re-pressurized to a higher pressure to reduce this degree of leakage. Re-pressurization is performed by accessing the needle port  8  with a needle to allow fluid communication between the hydraulic urethral occlusive device interior and a syringe attached to a pressure transducer. The pressure transducer is used to confirm the pressure infused into the hydraulic urethral occlusive device interior by the syringe. Alternately, the needle may be attached to a bag of saline which may then be elevated to provide a water column pressure equivalent to the pressure desired within the hydraulic urethral occlusive device interior. This procedure may be performed multiple times until the patient achieves the desired degree of continence. 
     The pressure maintained in the device may be defined as Pressure=Force/Cross-sectional Area as given above. The Cross-sectional Area is the fixed value established by the pressure compensator diaphragm  20 . However, the force generated by the constant force spring  34  is not perfectly constant and increases gradually with increased rotational displacement of the pulley  27  in which the constant force spring  34  is contained. The incremental fluid volume infused into the hydraulic urethral occlusive device interior during refilling/repressurization increases this rotational displacement to incrementally increase the interior pressure. 
       FIGS. 15A  and B show an embodiment of re-pressurization device  600  that can access the needle or injection port of the hydraulic urethral occlusive device (e.g. injection port  8  of device  1  in  FIG. 1 ) with a needle  602  to allow fluid communication between the hydraulic urethral occlusive device interior and a syringe  604  attached to a pressure transducer  606 . The pressure transducer  606  is used to confirm the pressure infused into the hydraulic urethral occlusive device interior by the syringe  604 . 
     As shown in  FIG. 15A , if following device implantation, a patient continues to leak urine unacceptably, then in some cases additional saline may be added to increase urethral occlusive pressure. In some embodiments, this is accomplished using the re-pressurization device  600 . In some embodiments, the re-pressurization device  600  includes a sterile pressure transducer  606 , a non-coring needle  602 , an infusion tube  610 , stopcock  608 , and an infusion syringe  604 . The infusion syringe  604  can be filled with sterile saline solution. 
     To add the saline solution in some embodiments the following steps may be performed: 
     Turn the HUOD (e.g. device  1  in  FIG. 1 ) and disinfect the scrotal skin over the control mechanism injection port (e.g. port  8  in  FIG. 1 ). Place sterile drapes around control mechanism needle insertion site to prevent infection. Activate and zero the display on the pressure transducer  606 , e.g. as shown in  FIG. 15B . It will be appreciated that the pressure transducer  606  shown may be replaced by a different pressure transducer calibrated with a certain intended pressure range. 
     Connect the pressure transducer  606  to infusion tube  610 , such as for example to a male luer side of the pressure transducer  606  (e.g. shown in  FIG. 15B ) and the stopcock  608  to a female luer end. Attach the needle  602  to the infusion tube  610  and the syringe  604  (filled with sterile normal saline to Stopcock). Flush the device  600  with saline to eliminate air bubbles. Close the stopcock  608 . The assembled device is shown in  FIG. 15A . 
     Insert the needle  602  through the scrotal tissue and into the HUOD injection port (e.g. port  8  of device  1  of  FIG. 1 ) such as for example until the needle  602  comes to a stop. 
     The pressure may then be displayed on the pressure transducer, such as shown in  FIGS. 15A  and B. 
     Open the stopcock  608  and slowly infuse saline from the syringe  604 . The saline can be added for example until the displayed pressure on the pressure transducer  606  is at least 80 cm H 2 O such as in certain examples. If the pressure is greater than 80 cm H 2 O, then saline can be infused to increase the pressure by 10 cm H 2 O. Close the stopcock  608 . 
     In some examples, the scrotal tissue is massaged directly over the implanted HUOD occlusive cuff to redistribute fluid within the occlusive cuff. The displayed pressure can then be read to determine if the pressure drops by more than 5 cm H 2 O. 
     If the pressure drops by more than 5 cm H 2 O, in some embodiments, the stopcock  608  is opened and saline infused until a pre-massage pressure is again reached. Close stopcock  608 . 
     Repeat scrotal massage as above, and infuse saline infusion as required until pre- and post-massage pressures are approximately the same, e.g. the pressure does not drop by more than 5 cm H 2 O. 
     Remove the needle  602  from injection port. In some embodiments any one or more of the infusion tube, needle, pressure transducer, stopcock, and syringe can be discarded. 
     Patients&#39; continence can be assessed by having the patient perform a provocative test intended to increase intra-abdominal pressure. If the patient continues to leak urine unacceptably, the re-pressurization procedure may be repeated until the desired degree of continence is achieved. 
     It will be appreciated that the pressure measured (e.g. is the pressure of the HUOD device measured by the pressure transducer  606 ) within the HUOD device (e.g. device  1  in  FIG. 1 ) has been demonstrated to provide acceptable continence within a range of about 80-130 cm H 2 O. The geometry and stiffness of the silicone occlusive cuff can limit the pressure exerted on the urethra and the pressure within the HUOD may be higher than that exerted on the urethra. If necessary, the actual intra-urethral pressure may be measured by passing a small diameter pressure measurement catheter through the urethra and past the point occluded by the cuff. This technique may artificially increase the measured urethral pressure due to the size and stiffness of the catheter itself. 
     Alternately, a Retrograde Perfusion Pressure (RPP) technique may be employed to measure the urethral closure pressure effected by the occlusive cuff. Using this technique, a small diameter tube is passed into the distal portion of the penile urethra. Clamping the penis against the catheter body to effect a fluid tight seal, infuse water through the catheter using an attached saline filled bag. Slowly elevate the bag to a height above the urethra at which flow through the catheter is demonstrated. This height is the urethral closure pressure. For intra-device pressures of 80-130 cm H 2 O, RPP measurements of 50-75 cm H 2 O are typically seen. 
       FIG. 14  shows an embodiment of post-implantation adjustment, for example to increase or decrease occlusive pressure, by way of using a retrograde perfusion technique. 
     Occlusive pressure may be increased by the incremental addition of volumes of hydraulic filling solution (e.g. normal saline), which may be known, fixed volumes of solution. Rather than measuring the achieved pressure as described above, a retrograde perfusion technique  500  may be employed to measure the urethral closure pressure directly. Retrograde perfusion can be performed using the following procedure and materials to determine a patient&#39;s urethral opening pressure (e.g. urethral occlusive pressure) once a satisfactory degree of continence is achieved. 
     As shown in  FIG. 14 , retrograde perfusion can be performed using a sterile saline intravenous (IV) bag  502 , a drip infusion set  504 , a urethral infusion catheter  506 , a measuring device  508  such as a measuring tape, and an IV stand  510 . 
     The retrograde perfusion materials, apparatus can be assembled as shown in  FIG. 14 . Once a patient has achieved a desired degree of continence, the hydraulic urethral occlusive device, e.g. as shown in  FIGS. 1, 8, 11, and 13 , can be activated. The scrotum and control mechanism  3  can be moved back and forth several times. The urethral infusion catheter can be inserted manually into the distal urethra and the penis grasped to affect a fluid tight seal between catheter and urethra. With infusion set clamps opened, the IV bag can be slowly elevated to the point at which dripping in the drip chamber is first seen. The column height H can be measured and then recorded as the urethral opening pressure. It will be appreciated that any of the hydraulic urethral occlusive devices described herein, including their accompanying components such as the occlusive cuff, pressure compensator, control mechanism, and conduit tubes, may be similarly used in a retrograde perfusion technique. 
     Alternative Electro-Mechanical Control Mechanism 
     The mechanical control mechanism  3 , described above, may be replaced by a closed loop, electro-mechanical, servo-control system. This system also has occlusive cuff  2  and pressure compensator diaphragm  20  as described above, a pulley  35 , rotary actuator such as a motor  36 , micro-processor based control mechanism  37 , power supply  38 , and separate urethral  39  and abdominal  40  pressure sensing elements. In this embodiment, the rotary actuator  36  turns the pulley  35  which, in turn, takes up and applies load to the tension sutures  41  to pressurize the pressure compensator diaphragm  20  and occlusive cuff  2  to occlude the urethra  13 . See e.g.  FIG. 8 . It is to be appreciated that a linear actuator such as a lead screw may be used in place of a rotary actuator. 
     In its resting state, the pulley  35  is biased so that the pressure compensator diaphragm  20  applies 0 to 20 cm H 2 O pressure to the urethra  13 . This pressure range is adequate to prevent urinary leakage during normal, unstressful activities. Urethral pressure is continuously or intermittently monitored by a urethral pressure sensing element  39  situated between the occlusive cuff  2  and the outer surface of the urethra  13 . Abdominal or bladder pressure is monitored continuously or intermittently by a pressure sensor  40  implanted within the abdominal cavity, within the abdominal wall, within the bladder or within the bladder wall. 
     As bladder filling occurs, bladder pressure increases within the range of 20-60. Sensing this pressure increase, the abdominal/bladder pressure sensor  40  signals the control mechanism  37  to turn the motor  36  on and cause the pulley  35  to rotate and affect a rise in urethral pressure. When the urethral pressure sensing element  39  detects that urethral pressure is 60-80 cm H 2 O, the motor  36  is turned off and the pulley  35  held in position to prevent any further pressure increase or decrease. Once the abdominal/bladder pressure reduces to 20 cm H 2 O or less, the control mechanism  37  is again signaled to allow the rotary actuator  36  to reverse direction and reduce tension on the traction sutures  41  until urethral pressures between 0 and 20 cm H 2 O are achieved. 
     Stressful events such as coughing, sneezing, laughing, etc. can often cause abdominal/bladder pressures spikes in excess of 60 cm H 2 O. Pressure rise times of 35 msec and elevated pressure durations of approximately 100 msec have been recorded. Sensing these pressure levels, the control mechanism  37  causes the rotary actuator  36  to turn on and rotate the pulley  35  to affect a rise in urethral pressure of as much as 120 cm H 2 O. When abdominal/bladder pressure declines to 20 cm H 2 O or less, the control mechanism  37  allows the rotary actuator  36  to reverse direction and reduce tension on the traction sutures  41  until urethral pressures between 0 and 20 cm H 2 O are achieved. 
     When the user wishes to void urine, a switch on the control mechanism  37  is manually activated through the skin. This action causes the pulley  35  to free-wheel, reducing traction suture  41  tension until a 0 cm H 2 O urethral pressure is achieved. The user then voids urine through the unobstructed urethra  13 . The user may then be required to manually depress the switch again to return the device to its resting mode or the device will be programmed to automatically return to its resting mode within 3-5 minutes. 
     Referring to  FIGS. 9, 10A, and 10B , another embodiment for closing or otherwise retaining and/or locking the occlusive cuff in place is shown.  FIG. 9  is a partial perspective view of another embodiment of an occlusive cuff  102  not encircling a urethra and shown in a flat condition.  FIG. 10A  is a partial view showing the occlusive cuff  102  of  FIG. 9  shown encircling a urethra but not in the fully clipped position.  FIG. 10B  is a partial view showing the occlusive cuff  102  of  FIG. 9  shown encircling a urethra in the fully clipped position. 
     As described with respect to the earlier Figures, the occlusive cuff  102  can have a thin-walled, expandable pouch  111  to which is affixed a semi-flexible cuff backing strip  112 . When encircling the urethra  113  (see e.g.  FIGS. 10A and 10B ), the fluid-tight expandable pouch  111  may be alternately expanded or deflated by infusion of a suitable filling media such as isotonic saline or radiopaque contrast media. Inflation occurs through a flexible input tube  114 . In one embodiment, the flexible input tube  114  can extend from connector end  119 , for example in a direction along the length of the expandable pouch  111  and backing strip  112 , which may help during manipulation and during implantation. The occlusive cuff  102  with the expandable pouch  111  may be inflated similar to that shown in  FIG. 3 . When the expandable pouch  111  is inflated, the pressure exerted on the urethra  113  is sufficient to prevent or minimize urinary leakage. Historical clinical evidence suggests that this pressure should be in the range of 60-80 cm H 2 O to provide adequate leak resistance without causing undue urethral atrophy or tissue erosion. When the expandable pouch  111  is deflated, pressure is removed from the urethra  113  to allow normal, unobstructed urinary drainage. The cuff backing strip  112  is positioned on the expandable pouch  111  surface away from the urethral surface and acts to maximize urethral occlusion efficiency by minimizing radial expansion of the expandable pouch  111  away from the urethra  113 . Sizing Detents  115  can also be positioned on the cuff backing strip  112  to allow the occlusive cuff  102  to be sized to accommodate anatomical variations in urethral circumferences as may occur in the human population. Clinical experience indicates that the range of urethral circumferences in the human male population ranges from about 3.5 cm to about 5.0 cm. Sizing indicators  116  may be associated with the detents  115  to provide the surgeon with urethral circumference information. 
     When the occlusive cuff  102  is surgically wrapped around the urethra  113 , the free end of the occlusive cuff  102  may retained by a retaining member  117 . The retaining member  117  in some embodiments can be a t-bar that may be inserted through any one of the openings  118  on the backing strip  112 . The openings  118  on the backing strip  112  can correspond to a size indicated by the indicators  116  and/or the sizing detents  115 . In some embodiments, the retaining member  117  can be a stainless steel t-bar, or may be a plastic material, or other suitably rigid material, and is also a material suitable for implant in a patient or subject. 
     It will be appreciated that any of the indicators  116  and/or sizing detents  115  may not be employed, and it will be appreciated that the specific t-bar configuration as shown in the figures is exemplary of the retaining member  117 , is not meant to be limiting, and may be suitably modified. 
     When the occlusive cuff  102  is surgically wrapped around the urethra  113 , the backing strip  112  can be advanced around the connecting end  119  and the retaining member  117  then secured through an opening  118  on the backing strip  112  to provide a close fit between the occlusive cuff  102  and urethra  113 . In one embodiment, the connecting end  119  can have a ramped side on which the retaining member  117  is disposed, and which may help during manipulation and during implantation and closure of the cuff  102 . 
     The structure shown in  FIGS. 9, 10A, and 10B  can also allow for adjustability and which provides a positive locking system to prevent the cuff from becoming accidentally disengaged. It will also be appreciated that the occlusive cuff closure shown in  FIGS. 9, 10A, and 10B  can incorporate a suitable retaining member, e.g.  117 , such as a stainless steel t-bar which engages openings in the occlusive cuff  102 , which may be an elastomeric, silicone occlusive cuff backing. In some embodiments, the openings  118  can be spaced to allow the occlusive cuff to accommodate urethras within a circumference range of about 3.0 cm to about 5.0 cm in about 0.5 cm increments. 
     It will be appreciated that the HUOD (e.g. device  1  of  FIG. 1 ) can be constructed and implemented as a totally implantable, one-piece artificial urinary sphincter for males who suffer from stress urinary incontinence (SUI). SUI is typically caused by urinary sphincter damage due to surgeries for the removal of cancerous prostates. An HUOD device herein includes an occlusive cuff encircling the urethra, a control mechanism implanted in the scrotum, and a pressure compensator implanted in the pre-pubic space. The occlusive cuff and pressure compensator are individually and permanently connected to the control mechanism by kink resistant conduit tubes (e.g. see  FIG. 1 ). 
     A user may control urine flow by activating or deactivating the silicone encased control mechanism located under the scrotal skin. When the control mechanism activation button is depressed, an increased hydraulic pressure is generated within the HUOD. A saline filling solution is then transferred through a conduit tube to inflate the occlusive cuff. Inflation causes the occlusive cuff to apply a radial occlusive pressure to the urethra sufficient to prevent urinary leakage. In some embodiments, depressing a separate deactivation button through the intact scrotal skin allows the occlusive cuff to deflate, and the patient is then free to void urine. 
     In anticipation of a stress event which may cause inadvertent urinary leakage, the user may manually press on the abdomen over the Pressure Compensator to temporarily increase the urethral occlusive pressure. Removing this manual pressure also reduces the increased urethral occlusive pressure. 
     At implantation, the occlusive cuff may be custom fit to the urethral circumference such as for example within the range of 3.5 to 5.0 cm. The custom fit for example can be in 0.25 cm increments. The occlusive cuff is then secured to this size with a device, such as a locking clip or the like. 
     If the occlusive pressure set at implantation does not provide the desired degree of continence, this pressure may be incrementally increased by percutaneous infusion of saline (e.g. re-pressurization) into the HUOD. 
     It will be appreciated that any of aspects 1 to 14 may be combined with any of aspects 15 to 22, and any of aspects 15 to 18, 21, and 22 may be combined with any of aspects 19 and 20. 
     Aspect 1. An implantable occlusive device, comprising: an occlusive cuff; a control mechanism; and a pressure compensator, the control mechanism is in fluid communication with the occlusive cuff, through attachment via a flexible tube, the control mechanism is in fluid communication with an inner portion of the pressure compensator, through attachment via a flexible conduit, the control mechanism including an activation button and a deactivation button, the activation button upon depression, hydraulically inflates with hydraulic fluid the occlusive cuff to apply a preset occlusive pressure on the tubular body, the deactivation button upon depression, hydraulically evacuates the hydraulic fluid from the occlusive cuff to remove the preset occlusive pressure on the tubular body. 
     Aspect 2. The device of aspect 1, wherein the occlusive cuff is adjustable to encircle a urethra. 
     Aspect 3. The device of aspect 1 or 2, wherein the occlusive cuff comprises an expandable pouch affixed to a cuff backing strip, the expandable pouch is inflatable when the hydraulic fluid enters the expandable pouch through the flexible tube so as to apply the preset urethral pressure, and the expandable pouch is deflatable when the hydraulic fluid evacuates from the expandable pouch through the flexible tube so as to remove the preset urethral pressure. 
     Aspect 4. The device of any of aspects 1 to 3, wherein the occlusive cuff comprises sizing detents, a free end, and a locking clip, the free end is insertable through the locking clip to lock the occlusive cuff to one of the sizing detents. 
     Aspect 5. The device of any of aspects 2 to 4, further comprising a retaining member at one end of the occlusive cuff, the retaining member is engageable with an opening through the cuff backing strip. 
     Aspect 6. The device of any of aspects 1 to 5, wherein the control mechanism is encapsulated by a silicone boot. 
     Aspect 7. The device of any of aspects 1 to 6, wherein the control mechanism comprises a septum. 
     Aspect 8. The device of any of aspects 1 to 7, further comprising a tension cord that travels from the control mechanism to a diaphragm defines a filling media volume inside the pressure compensator, the diaphragm is configured to operate between an expanded condition and a collapsed condition, the control mechanism configured to apply tension to the tension cord to collapse the diaphragm and the filling media volume into the collapsed condition, where the hydraulic fluid transfers to the occlusive cuff to inflate the occlusive cuff, and the control mechanism configured to release tension from the tension cord to evacuate the hydraulic fluid from the occlusive cuff, where the hydraulic fluid transfers to the pressure compensator to expand the diaphragm and the filling media volume to the expanded condition. 
     Aspect 9. The device of aspect 8, wherein the pressure compensator further comprises a shell, a fluid volume contained within the shell and that surrounds and is separated from the filling media volume, as the diaphragm is collapsed, fluid transfers into the fluid volume, and as the diaphragm expands, fluid transfers out of the fluid volume. 
     Aspect 10. The device of aspect 9, wherein the pressure compensator further comprises a dome, the dome is configured to allow fluid to transfer into the fluid volume when the diaphragm collapses and allow fluid to transfer out of the fluid volume when the diaphragm expands. 
     Aspect 11. The device of aspect 9 or 10, wherein the inner portion of the pressure compensator contains a fluid different from a fluid in the fluid volume. 
     Aspect 12. The device of any of aspects 1 to 11, wherein the pressure compensator comprises a septum. 
     Aspect 13. The device of any of aspects 1 to 12, wherein the control mechanism includes an electro mechanical control. 
     Aspect 14. The device of any of aspects 1 to 13, wherein the control mechanism is configured to incrementally increase occlusive pressure on the tubular body. 
     Aspect 15. A method of tubular body occlusion, comprising: collapsing a diaphragm inside a pressure compensator shell to transfer hydraulic fluid to an occlusive cuff, the transfer of hydraulic fluid being via conduits in fluid communication with a control mechanism; pressurizing the occlusive cuff as a result of the transfer of hydraulic fluid from the collapsing of the diaphragm inside the pressure compensator shell; occluding a tubular body surrounded by the occlusive cuff as a result of pressurizing of the occlusive cuff; and during a desired state of non-occlusion, depressurizing the occlusive cuff to transfer the hydraulic fluid from the occlusive cuff to the inside of the pressure compensator to thereby expand the diaphragm, and during a desired state of occlusion, repressurizing the occlusive cuff, by repeating the steps of collapsing, pressurizing, and occluding. 
     Aspect 16. The method of aspect 15, wherein the control mechanism is a mechanical control mechanism. 
     Aspect 17. The method of aspect 15 or 16, wherein the control mechanism is an electro mechanical control mechanism. 
     Aspect 18. The method of any of aspects 15 to 17, further comprising incrementally increasing pressure on the tubular body. 
     Aspect 19. The device of any of aspects 1 to 9 and 11, wherein the pressure compensator has a hollow flexible shell. 
     Aspect 20. The device of aspect 19, wherein the pressure compensator including its shell is configured for placement in one of a subcutaneous location or a pre-vesical location. 
     Aspect 21. The method of any of aspects 15 to 18, further comprising placing the pressure compensator in one of a subcutaneous location or a pre-vesical location. 
     Aspect 22. The method of any of aspects 15 to 18 and 21, further comprising repressurizing the device or determining the urethral occlusive pressure using a retrograde perfusion technique or re-pressurization device. 
     While the embodiments have been described in terms of various specific embodiments, those skilled in the art will recognize that the embodiments can be practiced with modification within the spirit and scope of the claims.