Artificial urinary sphincter system deflation assembly

An artificial urinary sphincter system includes a cuff implantable around a portion of a urethra, an implantable pressure-regulating reservoir, and a deflation assembly attachable between the cuff and the implantable pressure-regulating reservoir. The deflation assembly includes a valve that selectively restricts movement of the fluid from the cuff to the pressure-regulating reservoir, a base and an activation surface opposite the base. The activation surface includes an outer peripheral rim surrounding a pad that is movable to displace the valve to allow the fluid to flow from the cuff to the pressure-regulating reservoir. An entirety of the pad is recessed relative to the outer peripheral rim such that the outer peripheral rim defines a maxima of the activation surface.

BACKGROUND

An implanted penile prosthetic is effective in relieving erectile dysfunction in men.

A penile prosthetic typically includes one or more cylinders that are implanted in the corpora cavernosa of the penis, a reservoir implanted in the abdomen that communicates with the cylinder(s), and a pump located in the scrotum that is employed to move liquid from the reservoir into the cylinder(s).

In a typical application, the user squeezes a bulb of the pump multiple times to draw liquid out of the reservoir, into the bulb, and move the liquid into the cylinders. The repeated squeezing of the bulb moves the liquid from the reservoir into the cylinders, which incrementally deflates the reservoir and incrementally inflates the cylinder(s) to eventually provide the user with an erect penis. The user may return the penis to its flaccid state by activating a release mechanism associated with the pump to selectively transfer the liquid from the cylinder(s) back into the reservoir.

The above-described penile prosthetics have proven effective in relieving erectile dysfunction in men. However, there is a desire for improved penile prosthetic devices.

SUMMARY

One aspect provides an artificial urinary sphincter system including a cuff, an implantable pressure-regulating reservoir, and a deflation assembly. The cuff is implantable around a portion of a urethra. The deflation assembly is attachable between the cuff and the implantable pressure-regulating reservoir. The deflation assembly includes a valve that selectively restricts movement of the fluid from the cuff to the pressure-regulating reservoir, a base, and an activation surface opposite the base. The activation surface includes an outer peripheral rim surrounding a pad that is movable to displace the valve to allow the fluid to flow from the cuff to the pressure-regulating reservoir. An entirety of the pad is recessed relative to the outer peripheral rim such that the outer peripheral rim defines a maxima of the activation surface.

DETAILED DESCRIPTION

The term “proximal” as employed in this application means that the referenced part is situated next to or near the point of attachment or origin or a central point: as located toward a center of the human body. The term “distal” as employed in this application means that the referenced part is situated away from the point of attachment or origin or the central point: as located away from the center of the human body. A distal end is the furthest endmost location of a distal portion of a thing being described, whereas a proximal end is the nearest endmost location of a proximal portion of the thing being described. For example, the glans penis is located distal, and of the crus of the penis is located proximal relative to the male body such that a distal end of a corpora cavernosum of the patient extends about midway into the glans penis.

“Fluid” means a non-solid substance that flows and includes gases and liquids, or a combination of a gas and a liquid.

“Gas” means a substance having molecules that disperse and are free to expand to occupy an entire volume of a container in which it is disposed. Air and methyl butane are two examples of gases.

“Liquid” means a substance having molecules that do not disperse such that the liquid resists compression and the molecules of the liquid will not disperse to fill all spaces of a container in which the liquid is disposed. Saline is an example of a liquid.

“Maxima” means the point that is a maximum distance away from a surface. In this specification, a deflation assembly provides an activation surface that includes an outer peripheral rim surrounding an activation area, and the activation area is recessed in a concave configuration relative to the outer peripheral rim such that the outer peripheral rim is a maxima of the activation surface.

Ectopic refers to the placement of a penile prosthetic deflation assembly between fascia and an exterior surface of a pelvis of the patient.

Embodiments provide a penile prosthetic having a deflation assembly that is easily identifiable to allow the patient to locate and activate (i.e., palpate) the deflation assembly. The deflation assembly is provided separately from the reservoir and separately from the pump to allow the functional aspects of the pump and the deflation assembly to be decoupled. This permits the pump to be manufactured in a smaller than usual and allows the deflation assembly to be customized based on patient anatomy.

A penile prosthetic deflation assembly is usually implanted in a scrotum of the patient, where the thin skin of the scrotum allows for easy palpation of the deflation assembly. However, some patients do not have the dexterity to operate a deflation assembly that is implanted in the scrotum.

Some penile prosthetic devices include a deflation assembly incorporated with the pump. The pump is typically implanted in the scrotum of the patient. It has been observed that the pump can rotate after it is implanted. It is difficult for the user to locate the deflation mechanism incorporated into the pump if the pump rotates. Embodiments provide a deflation mechanism that is separate from the pump where the deflation mechanism includes a prominent and easily identifiable activation surface that is even identifiable through the skin and fat tissue layers of clinically obese users.

FIG. 1is a perspective view of one embodiment of an assembled penile prosthetic20. The penile prosthetic20includes a penile implant22, a reservoir24, a pump26, and a deflation assembly28. Each of the two illustrated penile implants22provides a “cylinder” that is implanted in a corpora cavernosum within the shaft of the penis. The reservoir24retains a fluid that is employed to inflate the penile implant22. The pump26is connected between the penile implant22and the reservoir24and operates to move the fluid from the reservoir24to the penile implant22to inflate the penile implant22to an erect state. The deflation assembly28functions to selectively restrict movement of the fluid from the penile implant22to the reservoir24to ensure that the penile implant22remains erect when inflated. In addition, the deflation assembly28functions to selectively move the fluid from the penile implant22back to the reservoir24to deflate the penile implant22to a flaccid state. The deflation assembly28provides a prominent activation surface (described below) that is easily palpated by the user.

In one embodiment, the penile implant22includes a pair of inflatable cylinders32that are sized to be implanted into the penis, and each of the cylinders32is connected to the pump26by tubes34. The tubes34are preferably kink-resistant. Each of the cylinders32includes a proximal end36opposite a distal end38. During implantation, the proximal end36(also called a rear tip) is implanted toward the crus of the penis and the distal end38is implanted within the glans penis. The cylinders32are fabricated from material configured to collapse and be flexible when the cylinders32are deflated to provide the penis with a comfortable flaccid state and expand when the cylinders32are inflated with liquid to provide the penis with an erection. Suitable material for fabricating the cylinders32includes silicone, polymers such as urethanes, blends of polymers with urethane, or copolymers of urethane, or the like. Suitable cylinders are available from Coloplast Corp., Minneapolis, Minn.

The reservoir24is sized to hold a volume of liquid between about 50-350 ml and is connected to the deflation assembly28by a tube44. The tube44is preferably kink-resistant. In one embodiment, the reservoir24is provided as a cylindrical reservoir formed from an elastic, flexible polymer with a wall thickness of between 0.005-0.060 inches. In one embodiment, the reservoir24is provided as a “cloverleaf” style of reservoir having multiple leaves that may be folded one against the other to compactly fold the reservoir24for implantation into the abdomen of the user. The reservoir24is fabricated from material suitable for body implantation, such as silicone or the urethane-based materials described above for the cylinders32. One suitable reservoir24is sized to contain approximately 130 ml of liquid and is available from Coloplast Corp., Minneapolis, Minn.

The pump26generally includes a bulb or other mechanism provided to move the fluid in the reservoir24to the penile implant22. The pump26is provided with a pair of inflation ports44that connect with the cylinders32via the tubes34and can include one or more suitable valve assemblies configured to check or limit the flow of the fluid to the cylinders32. The pump26is fabricated from material suitable for body implantation, such as silicone or the urethane-based materials described above for the cylinders32.

The deflation assembly28is separate from the reservoir24and separate from the pump26and is connected between the pump26and the reservoir24by a tube54. The tube54is preferably kink-resistant.

FIG. 2is a perspective view,FIG. 3is a side view, andFIG. 4is an end view of one embodiment of the deflation assembly28. The deflation assembly28includes a side surface60extending between a base62and activation surface64. In one embodiment, the side surface60includes an inlet port66that communicates with the reservoir24and an outlet port68that communicates the penile implant22(FIG. 1). The activation surface64includes an outer peripheral rim70surrounding an activation area72. The activation area72is recessed in a concave configuration relative to the outer peripheral rim70such that the outer peripheral rim70defines a maxima of the activation surface64(best illustrated inFIGS. 3 and 4). The activation area72provides a pad72that is central to the activation surface64. In one embodiment, the activation area72(or pad72) is entirely located between the outer peripheral rim70and the base62.

The rim70protects the activation area72from unintended activation. The rim70is configured to be hard or immovable and easily identifiable even through skin and tissue. The rim70provides a landmark that once located directs the user to the location of the pad72. The rim70is thus easily palpatable, but pushing on the rim70will not activate the deflation mechanism of the assembly28. The pad72is movable and protected by the rim70, but the pad72is easy to push once the rim70is located.

The activation area72is movable, and in one embodiment is fabricated from a polymer that is configured to be more flexible than the outer peripheral rim70. In one embodiment, the outer peripheral rim70is harder (i.e., has a higher durometer) than the activation area72. In one embodiment, the activation area72is movable and the outer peripheral rim70is immovable.

The deflation assembly28generally encloses a valve or some sort of valve assembly (FIG. 5) that is located between the inlet port66and the outlet port68. The valve is provided to selectively restrict movement of the fluid from the penile implant22to the reservoir24when the penile implant22is erect. The activation surface64, and in particular the activation area72, is operable to displace the valve to allow movement of the fluid from the penile implant22back to the reservoir24to return the penile implant22to a flaccid state.

In one embodiment, the activation area72is movable toward the base62to move a position of the valve. In one embodiment, the outer peripheral rim70is substantially immovable and provides a hard, easily palpatable surface for access by the user.

In one embodiment, the base62is a lower surface and the activation surface64is an upper surface of the deflation assembly28. The activation surface64provides a length L and a width W, and the side surface60provides a height H. In one embodiment, the length L of the activation surface64is larger than the height H of the side surface60. In one embodiment, the width W of the activation surface64is larger than the height H of the side surface60. In one embodiment, the length L and the width W of the activation surface64are each larger than the height H a side surface60.

FIG. 5is a cross-sectional view of the deflation assembly28. The deflation assembly28encloses a valve80that is disposed within a flow path82. The flow path82extends between the inlet port66and the outlet port68. In one embodiment, the valve80is a ball valve that is biased to seat against a valve seat84by a spring86.

With reference toFIG. 1, when the pump26is repeatedly squeezed it draws fluid from the reservoir24. The fluid drawn out of the reservoir24displaces the valve80off of the valve seat84to allow the fluid to flow through the flow path82and out of the outlet port68to the penile implant22. When the suction provided by the pump26is reduced, for example between squeezes of the pump or when the penile implant22is inflated, the spring86forces the valve80against the valve seat84and restricts movement of the fluid from the penile implant22back to the reservoir24. In one embodiment, the activation area72is movable and when pressed operates to displace the valve80off of the valve seat84to allow the fluid in the penile implant22to return to the reservoir24, which deflates penile implant22.

In one embodiment, the deflation assembly28is fabricated from polymer and integrally surrounds the valve80, the spring86, and the flow path82. In one embodiment, the deflation assembly28is molded from silicone as a monolithic and integral unit that encloses the valve80.

In one embodiment, the activation area72is provided as a diaphragm flap that extends from the rim70, and the diaphragm flap is movable to displace the valve80away from the seat84to allow fluid to pass through the flow path82.

FIG. 6is a schematic view of one embodiment of the penile prosthetic20implanted in a man

The cylinders32are each implanted into one of adjacent corpora cavernosum of the penis with the proximal end36implanted into the crus of the penis and the distal end38implanted into the glans penis. The reservoir24is implanted in the abdomen, either in front of or behind the pubic bone based on the surgeon's preference. The pump26is implanted in the scrotum. The deflation assembly28is connected between the reservoir24and the pump26and is implanted under the skin in front of (i.e., exterior to) the pelvis. Suitable locations for implantation of the deflation assembly28include between the transversalis fascia and an exterior surface of the pelvis, or behind the puborectalis muscle of the patient. Other suitable locations for implantation of the deflation assembly28include placing the base62of the deflation assembly28against an iliac fossa of the pelvis, or against an iliac crest of the pelvis, or against the pelvis between an anterior gluteal line and an iliac crest of the pelvis.

During use, the pump26is repeatedly squeezed to draw fluid from the reservoir24through the deflation assembly28and into the cylinders32implanted in the penis to move the penis from a flaccid state (solid lines) to an erect state (dotted lines). The valve80(FIG. 5) prevents the fluid from leaving the cylinders32and moving back into the reservoir24. The user presses on the activation area72of the deflation assembly28to selectively transfer the fluid in the cylinders32back to the reservoir24to move the penis from the erect state to the flaccid state. In this regard, the deflation assembly28is placed between transversalis fascia and an exterior surface of a pelvis of the patient and the outer peripheral rim70is configured to allow the patient to easily feel and locate the activation area72.

Other existing penile prosthetic devices associate the deflation assembly with the pump that is implanted and accessible in the scrotum, or with the reservoir that is implanted and accessible in the abdomen. However, the pump implanted in the scrotum can rotate over time or through use, which can make locating the deflation assembly difficult. Likewise, the reservoir implanted in the abdomen can move or shift, which makes locating the deflation assembly difficult. In addition, some patients have additional skin folds or a layer of fatty tissue in the abdominal region, which can present challenges to the user in locating the deflation assembly. In contrast, the deflation assembly described herein provides an activation surface having an outer peripheral rim that defines a maxima of the activation surface, which makes the deflation assembly easy to palpate (locate) and use. Specifically, the outer peripheral rim70is configured to allow a user to palpate through the skin and fatty tissues to locate the activation area.

Some penile prosthetic devices have a “low profile” reservoir that is designed to provide a minimal depth to reduce or eliminate the visibility of the reservoir when it is implanted. For example, this style of low profile reservoir allows the reservoir to be implanted in front of the puborectalis muscle and behind the abdominal fascia in a location that is not noticeable from an external view of the patient. If such a reservoir would be modified to include a deflation assembly, the deflation assembly would likewise be hidden from view and likely difficult to locate/palpate/identify. In direct contrast, the deflation assembly described herein provides an activation surface having an outer peripheral rim that is easily identifiable when the deflation assembly is placed between transversalis fascia and an exterior surface of a pelvis of the patient.

FIG. 7is a front view of a pelvis showing the deflation assembly28implanted against an iliac fossa of the pelvis. The base62of the deflation assembly28is placed against the iliac fossa with the tube44extending to the reservoir24and the tube54extending to the pump26. In this location, the deflation assembly28is located between the transversalis fascia and an exterior surface of the pelvis. The base62is thus placed against the hard surface of the iliac fossa and the outer peripheral rim70is easy to locate, which makes the activation area72easily palpatable.

FIG. 8is a side view of a pelvis showing the deflation assembly28implanted against an iliac crest of the pelvis. The base62of the deflation assembly28is located against the iliac crest with the tube44extending to the reservoir24and the tube54extending to the pump26. In one embodiment, the base62of the deflation assembly28is placed against the pelvis between an anterior gluteal line and an iliac crest of the pelvis as illustrated. The base62is thus placed against the hard surface of the iliac crest and the outer peripheral rim70is easy to locate, which makes the activation area72easily palpatable.

FIG. 9is a top view of a pelvis showing the deflation assembly28implanted between transversalis fascia and an exterior surface of the pelvis. In particular, the deflation assembly28is located against the iliac crest of the pelvis and behind the transversalis fascia.

In one embodiment, the deflation assembly28is implanted behind a puborectalis muscle of the patient.

Embodiments thus provide implantation of a deflation assembly such that the outer peripheral rim70is distal the pelvis.

FIG. 10Ais a cross-sectional view of one embodiment of a penile prosthetic deflation assembly100andFIG. 10Bis a cross-sectional view of a valve assembly102of the deflation assembly100. The deflation assembly100is operable with the kind of prosthetic described above, and is for example connected between the reservoir24and the pump26(FIGS. 1 and 6) to operate the penile implant22.

The deflation assembly100includes a side surface110extending between a base112and activation surface114. In one embodiment, the side surface110includes an inlet port116that communicates with the reservoir24and an outlet port118that communicates the penile implant22(FIG. 1). The activation surface114includes an outer peripheral rim120surrounding an activation area122. The activation area122is recessed in a concave configuration relative to the outer peripheral rim120such that the outer peripheral rim120defines a maxima of the activation surface114.

In one embodiment, the deflation assembly100encloses a stem valve130of the valve assembly102that is located between the inlet port116and the outlet port118. The stem valve130is provided to selectively restrict movement of the fluid from the penile implant22to the reservoir24(FIG. 1) when the penile implant22is erect. The activation surface114, and in particular the activation area122, is operable to displace the valve130to allow movement of the fluid from the penile implant22back to the reservoir24to return the penile implant22to a flaccid state.

In one embodiment, the activation area122is movable toward the base112to move a position of the valve130. In one embodiment, the outer peripheral rim120is substantially immovable and provides a hard, easily palpatable surface accessible by the user.

FIG. 10Billustrates one embodiment in which the stem valve130is shaped as a prong that extends from the activation area122toward the base112and is movable and so configured to displace an interface140between the valve130and a flow path142in which the valve130is seated. In one embodiment, the stem valve130includes a spring150that biases a check valve152into engagement with the interface140.

With additional reference toFIG. 1, repeated squeezing of the pump26causes fluid to be drawn from the reservoir24through the inlet port116(FIG. 10A), which displaces the check valve152and compresses the spring150, to move the check valve152off of the interface140to allow the fluid to flow through the flow path142, out of the outlet port118, and into to the implant22.

Artificial Urinary Sphincters

Urinary incontinence affects about 200 million people worldwide and about 25 million people in the US. Urinary incontinence is generally more prevalent in women than in men.

Urinary incontinence in women can be associated with a prolapse of one or more pelvic organs, which can arise from a weakness in the tissues/muscle of the pelvic floor. Urinary incontinence in men can arise after surgical treatment of the prostate glade, which treatment can include removal or weakening of the prostatic sphincter associated with the urinary urethra.

One treatment for urinary incontinence includes placing an artificial sphincter around a portion of the urethra. The artificial sphincter has a closed position that selectively prevents the flow of urine through the urethra, thus providing the user with a comfortable, continent state. The artificial sphincter can be activated to an open position by the user, which opens the urethra and allows the user to selectively pass urine.

Surgeons and patients would welcome advances in the treatment of urinary incontinence.

One urinary control system that has found favor with the medical community includes three components cooperatively attached with kink-resistant tubing: an occlusive cuff, a control pump, and a pressure-regulating balloon reservoir. The cuff is implanted around the urethra. The control pump is implanted in the scrotum of a male user. The pressure-regulating balloon reservoir is implanted in the prevesical space, for example through a suprapubic incision followed by dissection of the rectus fascia and a spreading of the linea alba. The three components are filled with liquid (saline) to provide a liquid-filled closed system maintained at an equilibrium pressure that closes the cuff around the urethra. When the user wishes to void, he squeezes and releases the pump several times to move fluid from the cuff into the pressure-regulating balloon reservoir. The cuff “deflates” and opens, which allows the urethra to open and pass urine. The pressure-regulating balloon reservoir, having been pressurized to a pressure above the equilibrium pressure by action of the pump, eventually automatically re-pressurizes the cuff to the equilibrium pressure over the course of several minutes to again inflate the cuff and coapt the urethra.

Embodiments described in this application provide an artificial urinary sphincter system having a cuff implantable around a portion of a urethra, an implantable pressure-regulating reservoir, and a deflation assembly attachable between the cuff and the implantable pressure-regulating reservoir. The pressure-regulating reservoir is to be implanted against the hard surface of the exterior pelvis (i.e., the iliac crest or the iliac fossa) such that the outer peripheral rim70is easy to locate, which makes the activation area72easily palpatable even for those users who have increased body mass or diminished dexterity. Activation of the activation area72(by a simple pressing motion with the fingers) followed by pressure applied to the cuff will deflate the cuff and allow the user to pass urine. In other words, pressing the activation area72and applying pressure to the cuff will increase the pressure in the reservoir and deflate the cuff. A subsequent second activation of the activation area72will allow the pressure to equalize between the reservoir and the cuff, which re-pressurizes the cuff and coapts the urethra.

Thus, embodiments provide an improved artificial urinary sphincter system that does not have a pump mechanism, and an improved artificial urinary sphincter system that has a deflation assembly that is ectopically located between fascia and an exterior surface of a pelvis of the patient for ease of access by the user.

FIG. 11is a perspective view of one embodiment of an artificial urinary sphincter (AUS) system200useful in treating urinary incontinence. The system includes a cuff202that is implantable around a portion of a urethra, an implantable pressure-regulating reservoir204, and the deflation assembly28or100described above that is attachable between the cuff202and the implantable pressure-regulating reservoir204, for example by kink-resistant tubing206. The system200obviates the use of the usual pump that is employed with the usual AUS systems.

The cuff202is implanted around the urethra and the pressure-regulating reservoir204is provided to pressurize the closed system200to suitable pressures that will coapt the urethra (e.g., 50-80 cm H2O). The deflation assembly28is operable to selectively restrict movement of the fluid from the cuff202to the pressure-regulating reservoir204. In certain configurations the deflation assembly28configures the system200to have substantially equal pressure in the cuff202and the reservoir204, for example when the cuff202coapts the urethra. In another configuration, the deflation assembly28configures the system200to have a lower pressure in the cuff202and a higher pressure in the reservoir204, for example when the cuff202is deflated to open the urethra to allow the user to pass urine.

The cuff202is implanted around the bulbous urethra or around the portion of the urethra descending from the bladder neck. The cuff202is sized to allow placement as close to the bladder as possible (desired by some surgeons), or positioned distal the bladder neck as suitably determined by the surgeon. The cuff202is generally about2cm wide and have varying lengths suited to different anatomical sizes, where the lengths are provided in a range from 4-11 cm.

The pressure-regulating reservoir204is provided as a balloon or other suitable flexible container and is usually implanted in the abdomen or prevesical space. In one embodiment, the pressure-regulating reservoir204is fabricated from silicone elastomer and is pressurized in a range of 50-80 cm H2O when implanted and attached to the components of the system200.

FIG. 12is a side view andFIG. 13is a top view of one embodiment of the cuff202. The cuff202illustrated inFIG. 11is in its implanted configuration, whereas the cuff202illustrated inFIG. 12is in its pre-implantation state.

The cuff202includes an expanding bladder portion232attached to a base230. A connector234is provided on the base230for connection with the tube206(FIG. 11), and the connector234communicates with the bladder portion232. In one embodiment, the bladder portion232is provided as a series of segments or pillows232a,232b,232cthat are configured to expand and inflate as liquid is directed into the cuff202through the connector234. In one embodiment, three of the segments or pillows are provided to allow the base230to be bent/folded or directed around the circumference of the urethra such that when the pillows232expand, substantially uniform pressure is applied to the urethra. The bladder portion232may include more than three or fewer than two segments or pillows.

In one embodiment, the base230extends from a first end portion236provided with a tab238to a second opposing end portion240provided with a slot242. Inserting the tab238into the slot242forms the cuff202into a substantially circular configuration configured for encircling the urethra of the user. Movement of liquid through the connector234inflates the bladder portion232, which is useful in inflating the cuff202to coapt the urethra to provide the user with a continent state.

FIG. 14is an end view of the cuff202with the tab238inserted into the slot242to form the cuff202into a substantially circular shape. The cuff202may thus be manipulated for placement around the urethra. When the cuff202is deflated (as illustrated by the dotted lines), the bladder portion232is deflated to remove or diminish pressure applied to the urethra, which allows the urethra to open and pass urine. In contrast, when the cuff202is inflated (as illustrated by the solid lines), the bladder portion232is inflated to apply pressure against the urethra to coapt the urethra and provide the user with a comfortable, continent state. In one embodiment, the cuff202is inflated to a pressure in the range of 50-80 cm H2O to coapt the urethra.

The cuff202is generally fabricated from synthetic material that is suitable for implantation into the human body and configured to retain a volume of liquid (for example when the bladder portion32of the cuff202is inflated). Suitable materials for fabricating the cuff202include silicone, flexible block copolymers, polyolefin, polybutylene, polyurethane, or mixtures or suitable copolymers of the synthetic materials.

FIG. 15is a cross-sectional view of the deflation assembly28. The deflation assembly28is similar to the deflation assembly28described above (FIG. 5) and is connected between the cuff202and the reservoir204(FIG. 11). When implanted and the system200is pressurized, the inlet port66of the deflation assembly28is connected to the reservoir204and the outlet port68is connected to the cuff202. In one embodiment, the valve assembly81includes the valve80that is biased against the seat84by the spring86, where the valve assembly81is located in the flow path82. In one embodiment, the deflation assembly100described above (FIGS. 10A and 10B) is suitable as the AUS deflation assembly illustrated inFIG. 11.

The system200illustrated inFIG. 11has at least two states, a continent state and a urine discharge state. In the continent state, the cuff202and the reservoir204are maintained at an equilibrium pressure that causes the cuff202to coapt the urethra and provide the user with continence. In the urine discharge state, the user will palpate the outer peripheral rim70which assists in locating the pad72. Compression applied to the pad72deflects or moves the valve80off of the seat84. Pressure applied to the cuff202, for example by the hand of the user pressing against the skin in the perineal area, will increase the pressure in the cuff202and drive the fluid from the cuff202through the valve assembly81and increase the pressure in the reservoir204. The increased pressure in the reservoir204is maintained by the valve80when biased against the seat84by the spring86. As a consequence of the liquid moving from the cuff202into the reservoir204, the cuff202deflates which allows the user to pass urine. After the user passes urine, the user will again press the pad72, and the pressure applied to the pad72will move the valve80off of the seat84and allow the pressure to equalize between the reservoir204and the cuff202.

FIG. 16is a schematic view of the system200implanted into a male user. The implantation of the system200in accordance with the instructions for use will follow the approved surgical procedures as established by the hospital or medical facility. Typically, the patient is brought into an operating room and prepared for surgery by appropriately cleaning and preparing the surgical site (e.g., the perineal area).

For placement of the cuff202in the region of the bulbous urethra, a perineal approach is employed that includes placing the patient in a lithotomy position, prepping and draping the patient, and then forming a perineal incision. Tissue is dissected within the perineal incision to access the region around the bulbous urethra. The cuff202is primed with liquid and placed around a portion of the urethra downstream from the neck N of the bladder B. Some surgeons have a preference to place the cuff202at that location where the urethra U transitions from a vertical arrangement near the neck N of the bladder B to a horizontal arrangement adjacent the perineal area that is associated with substantial protective muscle M mass.

The reservoir204is prepared and primed with liquid and implanted in the abdominal region of the patient, for example in a prevesical space as selected by the surgeon.

The deflation assembly28is prepared for implantation and primed with liquid prior to having the inlet port66connected to the tubing extending to the reservoir204and the outlet port68connected to the tubing extending to the cuff202. The act of priming the cuff202, the reservoir204, and the deflation assembly28(i.e., “primed”) includes pressurizing the system200to an equilibrium pressure that is suitable for closing the cuff202around the urethra to provide the user with a continent state.

The deflation assembly28is connected between the cuff202and the reservoir204and is implanted under the skin in front of (i.e., exterior to) the pelvis. Suitable locations for implantation of the deflation assembly28include those described above related to the penile prosthetic, such as between the transversalis fascia and an exterior surface of the pelvis, or behind the puborectalis muscle of the patient. Other suitable locations for implantation of the deflation assembly28include placing the base of the deflation assembly28against an iliac fossa of the pelvis, or against an iliac crest of the pelvis, or against the pelvis between an anterior gluteal line and an iliac crest of the pelvis so that the pad72projects outward for easy access by the user. Some AUS users have limited dexterity, and still other users have a body mass index of greater than 30, both conditions of which can limit the user's ability to operate the cuff202for passing urine and for creating the continent state. The system200provides an ectopically placed deflation assembly28having a pad72that is easily palpatable and accessible for operation of the cuff202.

With the system200implanted, the user is provided with a continent state where the system has an equilibrium pressure (between 50-80 cm of water) where the pressure in the cuff202is substantially equal to the pressure in the reservoir204. The pressure in the cuff202is selected to be sufficient to coapt the urethra.

When the user desires to void urine, the user presses on the pad72to selectively allow liquid to flow from the cuff202into the reservoir204. The flow of the liquid from the cuff202is assisted by the user applying pressure to the perineal area to compress the cuff202and drive the liquid from the cuff202through the deflation assembly28and into the reservoir204. The cuff deflates. The deflation assembly28maintains the pressure reservoir204at a higher pressure than the cuff202. The user passes urine. Thereafter, to return to the continent state, the user presses on the pad72to allow the deflation assembly28to permit liquid to flow from the reservoir204back into the cuff202. The pressure is equalized between the cuff202and the reservoir204, which allows the cuff202to coapt the urethra.

Embodiments provide a method of treating urinary incontinence, where the method includes implanting a cuff around a portion of a urethra; coupling the cuff to a reservoir and a deflation assembly, where the deflation assembly is located between the reservoir and separate from the cuff; and implanting the deflation assembly between transversalis fascia and an exterior surface of a pelvis of the patient. One method includes implanting a base of the deflation assembly against a pubic bone of the pelvis. One method includes positioning a pad of an activation surface of the deflation assembly away from the pelvis and so positioned to allow the patient to palpate the pad through skin.