Abstract:
A surgical method of treating erectile dysfunction includes implanting a penile prosthetic in a patient. The penile prosthetic includes an inflatable portion implantable into a penis that is attachable to a liquid reservoir, a pump, and a deflation assembly. The method includes implanting the deflation assembly in contact with an exterior surface of a pelvis of the patient, and positioning an activation surface of the deflation assembly away from the exterior surface of the pelvis. The method thus allows the patient to palpate the activation surface through skin.

Description:
BACKGROUND 
       [0001]    An implanted penile prosthetic is effective in relieving erectile dysfunction in men. 
         [0002]    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). 
         [0003]    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. 
         [0004]    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 
       [0005]    One aspect provides a penile prosthetic that includes a cylinder, a reservoir, a pump, and a deflation assembly. The cylinder is implantable in a corpora cavernosum. The pump is attachable between the cylinder and the reservoir and is operable to move fluid from the reservoir to inflate the cylinder. The deflation assembly is attachable between the pump and the reservoir and includes a valve that selectively restricts movement of the fluid from the cylinder to the reservoir, a base and an activation surface opposite the base, where 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 cylinder to the 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. 
         [0006]    One aspect provides a method of implanting a medical device that includes implanting an inflatable penile prosthetic into a penis of a patient, coupling the penile prosthetic to a reservoir, a pump, and a deflation assembly, where the deflation assembly is separate from the reservoir and separate from the pump. The method additionally includes implanting the deflation assembly between transversalis fascia and an exterior surface of a pelvis of the patient. The deflation assembly includes a palpatable activation surface. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]    The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts. 
           [0008]      FIG. 1  is a perspective view of one embodiment of a penile prosthetic including a reservoir, a pump, and a deflation assembly separate from the reservoir and the pump. 
           [0009]      FIG. 2  is a perspective view of one embodiment of the deflation assembly illustrated in  FIG. 1 . 
           [0010]      FIG. 3  is a side view of the deflation assembly illustrated in  FIG. 2 . 
           [0011]      FIG. 4  is an end view of the deflation assembly illustrated in  FIG. 2 . 
           [0012]      FIG. 5  is a cross-sectional view of one embodiment of the deflation assembly illustrated in  FIG. 3 . 
           [0013]      FIG. 6  is a schematic view of one embodiment of the penile prosthetic illustrated in  FIG. 1  implanted in a man. 
           [0014]      FIG. 7  is a front view of a pelvis showing the deflation assembly illustrated in  FIG. 1  implanted against an iliac fossa of the pelvis. 
           [0015]      FIG. 8  is a side view of a pelvis showing the deflation assembly illustrated in  FIG. 1  implanted against an iliac crest of the pelvis. 
           [0016]      FIG. 9  is a top view of a pelvis showing the deflation assembly illustrated in  FIG. 1  implanted between transversalis fascia and an exterior surface of the pelvis. 
           [0017]      FIG. 10A  is a cross-sectional view of one embodiment of a penile prosthetic deflation assembly. 
           [0018]      FIG. 10B  is a cross-sectional view of one embodiment of a valve assembly of the deflation assembly illustrated in  FIG. 10A . 
       
    
    
     DETAILED DESCRIPTION 
       [0019]    In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims. 
         [0020]    It is to be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically noted otherwise. 
         [0021]    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. 
         [0022]    “Fluid” means a non-solid substance that flows and includes gases and liquids, or a combination of a gas and a liquid. 
         [0023]    “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. 
         [0024]    “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. 
         [0025]    “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. 
         [0026]    Ectopic refers to the placement of a penile prosthetic deflation assembly between fascia and an exterior surface of a pelvis of the patient. 
         [0027]    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. 
         [0028]    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. 
         [0029]    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. 
         [0030]      FIG. 1  is a perspective view of one embodiment of an assembled penile prosthetic  20 . The penile prosthetic  20  includes a penile implant  22 , a reservoir  24 , a pump  26 , and a deflation assembly  28 . Each of the two illustrated penile implants  22  provides a “cylinder” that is implanted in a corpora cavernosum within the shaft of the penis. The reservoir  24  retains a fluid that is employed to inflate the penile implant  22 . The pump  26  is connected between the penile implant  22  and the reservoir  24  and operates to move the fluid from the reservoir  24  to the penile implant  22  to inflate the penile implant  22  to an erect state. The deflation assembly  28  functions to selectively restrict movement of the fluid from the penile implant  22  to the reservoir  24  to ensure that the penile implant  22  remains erect when inflated. In addition, the deflation assembly  28  functions to selectively move the fluid from the penile implant  22  back to the reservoir  24  to deflate the penile implant  22  to a flaccid state. The deflation assembly  28  provides a prominent activation surface (described below) that is easily palpated by the user. 
         [0031]    In one embodiment, the penile implant  22  includes a pair of inflatable cylinders  32  that are sized to be implanted into the penis, and each of the cylinders  32  is connected to the pump  26  by tubes  34 . The tubes  34  are preferably kink-resistant. Each of the cylinders  32  includes a proximal end  36  opposite a distal end  38 . During implantation, the proximal end  36  (also called a rear tip) is implanted toward the crus of the penis and the distal end  38  is implanted within the glans penis. The cylinders  32  are fabricated from material configured to collapse and be flexible when the cylinders  32  are deflated to provide the penis with a comfortable flaccid state and expand when the cylinders  32  are inflated with liquid to provide the penis with an erection. Suitable material for fabricating the cylinders  32  includes 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. 
         [0032]    The reservoir  24  is sized to hold a volume of liquid between about 50-350 ml and is connected to the deflation assembly  28  by a tube  44 . The tube  44  is preferably kink-resistant. In one embodiment, the reservoir  24  is 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 reservoir  24  is provided as a “cloverleaf” style of reservoir having multiple leaves that may be folded one against the other to compactly fold the reservoir  24  for implantation into the abdomen of the user. The reservoir  24  is fabricated from material suitable for body implantation, such as silicone or the urethane-based materials described above for the cylinders  32 . One suitable reservoir  24  is sized to contain approximately 130 ml of liquid and is available from Coloplast Corp., Minneapolis, Minn. 
         [0033]    The pump  26  generally includes a bulb or other mechanism provided to move the fluid in the reservoir  24  to the penile implant  22 . The pump  26  is provided with a pair of inflation ports  44  that connect with the cylinders  32  via the tubes  34  and can include one or more suitable valve assemblies configured to check or limit the flow of the fluid to the cylinders  32 . The pump  26  is fabricated from material suitable for body implantation, such as silicone or the urethane-based materials described above for the cylinders  32 . 
         [0034]    The deflation assembly  28  is separate from the reservoir  24  and separate from the pump  26  and is connected between the pump  26  and the reservoir  24  by a tube  54 . The tube  54  is preferably kink-resistant. 
         [0035]      FIG. 2  is a perspective view,  FIG. 3  is a side view, and  FIG. 4  is an end view of one embodiment of the deflation assembly  28 . The deflation assembly  28  includes a side surface  60  extending between a base  62  and activation surface  64 . In one embodiment, the side surface  60  includes an inlet port  66  that communicates with the reservoir  24  and an outlet port  68  that communicates the penile implant  22  ( FIG. 1 ). The activation surface  64  includes an outer peripheral rim  70  surrounding an activation area  72 . The activation area  72  is recessed in a concave configuration relative to the outer peripheral rim  70  such that the outer peripheral rim  70  defines a maxima of the activation surface  64  (best illustrated in  FIGS. 3 and 4 ). The activation area  72  provides a pad  72  that is central to the activation surface  64 . In one embodiment, the activation area  72  (or pad  72 ) is entirely located between the outer peripheral rim  70  and the base  62 . 
         [0036]    The rim  70  protects the activation area  72  from unintended activation. The rim  70  is configured to be hard or immovable and easily identifiable even through skin and tissue. The rim  70  provides a landmark that once located directs the user to the location of the pad  72 . The rim  70  is thus easily palpatable, but pushing on the rim  70  will not activate the deflation mechanism of the assembly  28 . The pad  72  is movable and protected by the rim  70 , but the pad  72  is easy to push once the rim  70  is located. 
         [0037]    The activation area  72  is movable, and in one embodiment is fabricated from a polymer that is configured to be more flexible than the outer peripheral rim  70 . In one embodiment, the outer peripheral rim  70  is harder (i.e., has a higher durometer) than the activation area  72 . In one embodiment, the activation area  72  is movable and the outer peripheral rim  70  is immovable. 
         [0038]    The deflation assembly  28  generally encloses a valve or some sort of valve assembly ( FIG. 5 ) that is located between the inlet port  66  and the outlet port  68 . The valve is provided to selectively restrict movement of the fluid from the penile implant  22  to the reservoir  24  when the penile implant  22  is erect. The activation surface  64 , and in particular the activation area  72 , is operable to displace the valve to allow movement of the fluid from the penile implant  22  back to the reservoir  24  to return the penile implant  22  to a flaccid state. 
         [0039]    In one embodiment, the activation area  72  is movable toward the base  62  to move a position of the valve. In one embodiment, the outer peripheral rim  70  is substantially immovable and provides a hard, easily palpatable surface for access by the user. 
         [0040]    In one embodiment, the base  62  is a lower surface and the activation surface  64  is an upper surface of the deflation assembly  28 . The activation surface  64  provides a length L and a width W, and the side surface  60  provides a height H. In one embodiment, the length L of the activation surface  64  is larger than the height H of the side surface  60 . In one embodiment, the width W of the activation surface  64  is larger than the height H of the side surface  60 . In one embodiment, the length L and the width W of the activation surface  64  are each larger than the height H a side surface  60 . 
         [0041]      FIG. 5  is a cross-sectional view of the deflation assembly  28 . The deflation assembly  28  encloses a valve  80  that is disposed within a flow path  82 . The flow path  82  extends between the inlet port  66  and the outlet port  68 . In one embodiment, the valve  80  is a ball valve that is biased to seat against a valve seat  84  by a spring  86 . 
         [0042]    With reference to  FIG. 1 , when the pump  26  is repeatedly squeezed it draws fluid from the reservoir  24 . The fluid drawn out of the reservoir  24  displaces the valve  80  off of the valve seat  84  to allow the fluid to flow through the flow path  82  and out of the outlet port  68  to the penile implant  22 . When the suction provided by the pump  26  is reduced, for example between squeezes of the pump or when the penile implant  22  is inflated, the spring  86  forces the valve  80  against the valve seat  84  and restricts movement of the fluid from the penile implant  22  back to the reservoir  24 . In one embodiment, the activation area  72  is movable and when pressed operates to displace the valve  80  off of the valve seat  84  to allow the fluid in the penile implant  22  to return to the reservoir  24 , which deflates penile implant  22 . 
         [0043]    In one embodiment, the deflation assembly  28  is fabricated from polymer and integrally surrounds the valve  80 , the spring  86 , and the flow path  82 . In one embodiment, the deflation assembly  28  is molded from silicone as a monolithic and integral unit that encloses the valve  80 . 
         [0044]    In one embodiment, the activation area  72  is provided as a diaphragm flap that extends from the rim  70 , and the diaphragm flap is movable to displace the valve  80  away from the seat  84  to allow fluid to pass through the flow path  82 . 
         [0045]      FIG. 6  is a schematic view of one embodiment of the penile prosthetic  20  implanted in a man. 
         [0046]    The cylinders  32  are each implanted into one of adjacent corpora cavernosum of the penis with the proximal end  36  implanted into the crus of the penis and the distal end  38  implanted into the glans penis. The reservoir  24  is implanted in the abdomen, either in front of or behind the pubic bone based on the surgeon&#39;s preference. The pump  26  is implanted in the scrotum. The deflation assembly  28  is connected between the reservoir  24  and the pump  26  and is implanted under the skin in front of (i.e., exterior to) the pelvis. Suitable locations for implantation of the deflation assembly  28  include 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 assembly  28  include placing the base  62  of the deflation assembly  28  against 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. 
         [0047]    During use, the pump  26  is repeatedly squeezed to draw fluid from the reservoir  24  through the deflation assembly  28  and into the cylinders  32  implanted in the penis to move the penis from a flaccid state (solid lines) to an erect state (dotted lines). The valve  80  ( FIG. 5 ) prevents the fluid from leaving the cylinders  32  and moving back into the reservoir  24 . The user presses on the activation area  72  of the deflation assembly  28  to selectively transfer the fluid in the cylinders  32  back to the reservoir  24  to move the penis from the erect state to the flaccid state. In this regard, the deflation assembly  28  is placed between transversalis fascia and an exterior surface of a pelvis of the patient and the outer peripheral rim  70  is configured to allow the patient to easily feel and locate the activation area  72 . 
         [0048]    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 rim  70  is configured to allow a user to palpate through the skin and fatty tissues to locate the activation area. 
         [0049]    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. 
         [0050]      FIG. 7  is a front view of a pelvis showing the deflation assembly  28  implanted against an iliac fossa of the pelvis. The base  62  of the deflation assembly  28  is placed against the iliac fossa with the tube  44  extending to the reservoir  24  and the tube  54  extending to the pump  26 . In this location, the deflation assembly  28  is located between the transversalis fascia and an exterior surface of the pelvis. The base  62  is thus placed against the hard surface of the iliac fossa and the outer peripheral rim  70  is easy to locate, which makes the activation area  72  easily palpatable. 
         [0051]      FIG. 8  is a side view of a pelvis showing the deflation assembly  28  implanted against an iliac crest of the pelvis. The base  62  of the deflation assembly  28  is located against the iliac crest with the tube  44  extending to the reservoir  24  and the tube  54  extending to the pump  26 . In one embodiment, the base  62  of the deflation assembly  28  is placed against the pelvis between an anterior gluteal line and an iliac crest of the pelvis as illustrated. The base  62  is thus placed against the hard surface of the iliac crest and the outer peripheral rim  70  is easy to locate, which makes the activation area  72  easily palpatable. 
         [0052]      FIG. 9  is a top view of a pelvis showing the deflation assembly  28  implanted between transversalis fascia and an exterior surface of the pelvis. In particular, the deflation assembly  28  is located against the iliac crest of the pelvis and behind the transversalis fascia. 
         [0053]    In one embodiment, the deflation assembly  28  is implanted behind a puborectalis muscle of the patient. 
         [0054]    Embodiments thus provide implantation of a deflation assembly such that the outer peripheral rim  70  is distal the pelvis. 
         [0055]      FIG. 10A  is a cross-sectional view of one embodiment of a penile prosthetic deflation assembly  100  and  FIG. 10B  is a cross-sectional view of a valve assembly  102  of the deflation assembly  100 . The deflation assembly  100  is operable with the kind of prosthetic described above, and is for example connected between the reservoir  24  and the pump  26  ( FIGS. 1 and 6 ) to operate the penile implant  22 . 
         [0056]    The deflation assembly  100  includes a side surface  110  extending between a base  112  and activation surface  114 . In one embodiment, the side surface  110  includes an inlet port  116  that communicates with the reservoir  24  and an outlet port  118  that communicates the penile implant  22  ( FIG. 1 ). The activation surface  114  includes an outer peripheral rim  120  surrounding an activation area  122 . The activation area  122  is recessed in a concave configuration relative to the outer peripheral rim  120  such that the outer peripheral rim  120  defines a maxima of the activation surface  114 . 
         [0057]    In one embodiment, the deflation assembly  100  encloses a stem valve  130  of the valve assembly  102  that is located between the inlet port  116  and the outlet port  118 . The stem valve  130  is provided to selectively restrict movement of the fluid from the penile implant  22  to the reservoir  24  ( FIG. 1 ) when the penile implant  22  is erect. The activation surface  114 , and in particular the activation area  122 , is operable to displace the valve  130  to allow movement of the fluid from the penile implant  22  back to the reservoir  24  to return the penile implant  22  to a flaccid state. 
         [0058]    In one embodiment, the activation area  122  is movable toward the base  112  to move a position of the valve  130 . In one embodiment, the outer peripheral rim  120  is substantially immovable and provides a hard, easily palpatable surface accessible by the user. 
         [0059]      FIG. 10B  illustrates one embodiment in which the stem valve  130  is shaped as a prong that extends from the activation area  122  toward the base  112  and is movable and so configured to displace an interface  140  between the valve  130  and a flow path  142  in which the valve  130  is seated. In one embodiment, the stem valve  130  includes a spring  150  that biases a check valve  152  into engagement with the interface  140 . 
         [0060]    With additional reference to  FIG. 1 , repeated squeezing of the pump  26  causes fluid to be drawn from the reservoir  24  through the inlet port  116  ( FIG. 10A ), which displaces the check valve  152  and compresses the spring  150 , to move the check valve  152  off of the interface  140  to allow the fluid to flow through the flow path  142 , out of the outlet port  118 , and into to the implant  22 . 
         [0061]    Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of medical devices as discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.