Abstract:
A method of implanting a penile prosthetic in a man includes providing a reservoir having a first major surface separated from to a second major surface by a side wall, the first major surface and the second major surface are both concave and form opposed depressions in the reservoir when the reservoir is empty of liquid. The method additionally includes connecting the reservoir to a pump that is connected to a cylinder, implanting the pump in the scrotum, implanting the cylinder in a corpora cavernosum of the penis, and implanting the reservoir in the man.

Description:
BACKGROUND 
       [0001]    An implanted penile prosthetic is effective in relieving erectile dysfunction in men. 
         [0002]    A penile prosthetic typically includes a cylinder that is implanted in each corpora cavernosum of the penis, a reservoir implanted in the abdomen that communicates with the cylinders, and a pump, often located in the scrotum, that is employed to move liquid from the reservoir into the cylinders. 
         [0003]    In a typical application, the user squeezes a bulb of the pump multiple times to incrementally draw liquid out of the reservoir, into the bulb, and eventually 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 cylinders to eventually provide the user with an erect penis. The user may return the penis to its flaccid state by selectively transferring the liquid from the cylinders back into the reservoir. 
         [0004]    The above-described penile prosthetics have proven effective in relieving erectile dysfunction in men. However, there is a continued desire for more efficient, discreet, and effective penile prostheses. 
       SUMMARY 
       [0005]    One aspect provides an implantable penile prosthetic including a pump attachable between a reservoir and a cylinder that is implantable into a corpora cavernosum of a penis. The reservoir has a central longitudinal axis and includes a wall connected between a first edge of a first surface and a second edge of a second surface. The first surface is concave relative to the first edge and the second surface is concave relative to the second edge such that each of the first and second surfaces form a depression in the reservoir when the reservoir is empty of liquid. The reservoir expands to contain liquid such that the first surface and the second surface are both convex relative to the central longitudinal axis. 
         [0006]    One aspect provides a method of implanting a penile prosthetic in a man. The method includes providing a reservoir having a first major surface separated from to a second major surface by a side wall, the first major surface and the second major surface are both concave and form opposed depressions in the reservoir when the reservoir is empty of liquid. The method additionally includes connecting the reservoir to a pump that is connected to a cylinder, implanting the pump in the scrotum, implanting the cylinder in a corpora cavernosum of the penis, and implanting the reservoir in the man. 
     
    
     
       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 an implantable penile prosthetic including a reservoir. 
           [0009]      FIG. 2  is a side cross-sectional view of the reservoir illustrated in  FIG. 1 . 
           [0010]      FIG. 3  is an end cross-sectional view of the reservoir illustrated in  FIG. 1 . 
           [0011]      FIG. 4  is a top perspective view of the reservoir illustrated in  FIG. 1 . 
           [0012]      FIG. 5  is a bottom perspective view of the reservoir illustrated in  FIG. 1 . 
           [0013]      FIG. 5  is a cross-sectional view of the pump in a configuration suited to pressurize the pressure reservoir illustrated in  FIG. 1 . 
           [0014]      FIG. 6  is a side view of the reservoir illustrated in  FIG. 1  when filled with liquid. 
           [0015]      FIG. 7  is a schematic view of the implantable penile prosthetic illustrated in  FIG. 1  implanted in a man. 
       
    
    
     DETAILED DESCRIPTION 
       [0016]    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. 
         [0017]    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. 
         [0018]    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. 
         [0019]    “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. 
         [0020]    In this specification, a “major surface” is a surface of a three-dimensional object that provides the object with most of its surface area. As an example, a sheet of paper generally has a front side and a back side with a thin edge thickness between the front and back sides; the front side and the back side are both major surfaces. 
         [0021]    In this specification, a reservoir is “filled with liquid” when the reservoir contains some amount of liquid; that is, the reservoir is not empty of liquid. In this specification, a “reservoir expands to contain liquid” means that the reservoir flexes to contain some amount of liquid more than the reservoir contains in its empty state. 
         [0022]    Embodiments provide an implantable penile prosthetic having a reservoir that is provided with a low profile that is unobtrusive to the user. The reservoir includes opposing concave depressions formed in the major surfaces that configure the reservoir with a low profile when implanted. The opposing concave depressions of the reservoir allow the reservoir to expand comfortably and discreetly when implanted and filled with liquid. When implanted, the reservoir presents such a discreet profile as to be nearly imperceptible. Embodiments of the reservoir include differential concave surfaces that expand to different extents, which allows the reservoir to expand more inwardly into the body than outwardly, and this contributes to its discreet implanted profile. 
         [0023]      FIG. 1  is a perspective view of one embodiment of an implantable penile prosthetic  20 . The penile prosthetic  20  includes a pump  22  attachable to a penile implant  24  and a reservoir  26 . Generally, suitable connections are made as the pump  22  is implanted into the scrotum of the user, the penile implant  24  is implanted into corpora cavernosa of the penis, and the reservoir  26  is implanted within the abdomen of the user. The penile prosthetic  20  is illustrated in a configuration in which the components have been coupled together and the reservoir  26  is not filled with liquid. 
         [0024]    The pump  22  includes a bulb  27  that is operable (for example by squeezing of the bulb  27 ) to move liquid stored in the reservoir  26  into the penile implant  24 . In one embodiment, the penile prosthetic  20  includes a release mechanism  28  associated with the pump  22  that is operable to hold or “check” the liquid in the penile implant  24  after the liquid has been transferred into the penile implant  24 . The release mechanism  28  is configured to be manually operated by the user to selectively release the liquid in the penile implant  24  back to the reservoir  26  through the tube  30 , for example when pads  31  on the release mechanism  28  are pushed. The pump  22  is fabricated from material suitable for body implantation, such as silicone, polymers such as urethanes, blends of polymers with urethane, copolymers of urethane, or the like. 
         [0025]    The penile implant  24  includes a pair of inflatable cylinders  32 , each of which is sized to be implanted into a corpora cavernosum of the penis. Each of the cylinders  32  is connected to the pump  22  by a tube  34 . 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 flaccid state and expand when the cylinders  32  are inflated with liquid to provide the penis with an erect state. Suitable material for fabricating the cylinders  32  includes silicone, polymers such as urethanes, blends of polymers with urethane, copolymers of urethane, or the like. Suitable cylinders are available from Coloplast Corp., Minneapolis, Minn. 
         [0026]    The reservoir  26  includes a neck  40  that is attached to the tube  30 . The reservoir includes a central longitudinal axis CL that projects through a center of the neck  40 . The “top” and “bottom” surfaces are major surfaces, and each of the major surfaces of the reservoir  26  is concave when the reservoir  26  is empty of liquid (as it is first implanted prior to being filled with liquid), which provides the reservoir  26  with a low profile. In one embodiment, each of the major concave surfaces is uniformly concave (the major surfaces are equally concave or “bi-concave”). The concave configuration of the major surfaces of the reservoir  26  allows the reservoir  26  to expand a substantial amount when filled with liquid (when the cylinders  32  are flaccid). In one embodiment, the concave major surfaces expand to convex shapes when the reservoir  26  is filled with liquid, which translates the reservoir  26  into a nearly cylindrical shape. In one embodiment, the major concave surfaces are not uniformly concave. 
         [0027]      FIG. 2  is a side cross-sectional view of the reservoir  26 . The reservoir  26  includes an end wall  50  opposite the neck  40 . The end wall  50  extends between a first edge  52  of a first surface  54  and a second edge  62  of a second surface  64 . In one embodiment, the first surface  54  is concave relative to the first edge  52  and the second surface  64  is concave relative to the second edge  62  such that each of the first and second surfaces  54 ,  64  form a depression in the reservoir  26  when the reservoir is empty of liquid (as illustrated). In one embodiment, the first edge  52  and the second edge  62  are substantially planar when the reservoir  26  is empty of liquid and the first surface  54  is concave relative to the planar first edge  52  and the second surface  64  is concave relative to the planar second edge  62 . 
         [0028]    In one embodiment, the first surface  54  is equally concave with the second surface  64  (“bi-concave”) and the depth of the first surface  54  relative to the first edge  52  is substantially equal to the depth of the second surface  64  relative the second edge  62 . 
         [0029]    In one embodiment, the concavity of the first surface  54  is different from the concavity of the second surface  64 . In an exemplary embodiment, the first surface  54  has a depth D 1  and the second surface  64  has a depth D 2 , where the depth D 2  is greater than the depth D 1 . In one embodiment, a radius of curvature for the first surface  54  is less than a radius of curvature for the second surface  64  such that the reservoir  26  has major surfaces  54 ,  64  that have different concavity. 
         [0030]    In one embodiment, the first edge  52  and the first surface  54  combine to form a first major surface, and the second edge  62  and the second surface  64  combine to form a second major surface, where the major surfaces are distinguished over the other surfaces (the end wall  50  and the neck  40 , for example) in that they each have more area than other surfaces of the reservoir  26 . 
         [0031]    The side view of  FIG. 2  illustrates that the first surface  54  has a curvature that extends between the end wall  50  and the neck  40 , where the first surface  54  curves about a first transverse axis TA 1  that is not parallel to the central longitudinal axis CL. In a similar manner, the second surface  64  has a curvature that extends between the end wall  50  and the neck  40  that curves about a second transverse axis TA 2  that is not parallel to the central longitudinal axis CL. 
         [0032]    In one embodiment, the reservoir  26  is fabricated around a mold such that the thickness of the end wall  50 , the thickness of the neck  40 , and the thickness of the surfaces  54 ,  64  are substantially equal. The first surface  54  and the second surface  64  are configured to be flexible. With this in mind, one embodiment of the reservoir  26  provides for the thickness of the first and second major surfaces  54 ,  64  to be thinner than the neck  40  and the end wall  50 . Suitable material for fabricating the reservoir  26  includes silicone, polymers such as urethanes, blends of polymers with urethane, copolymers of urethane, or the like. In one exemplary fabrication process, one of the suitable materials identified above is coated over a mandrel, and when hardened, is peeled off of the mandrel to provide the reservoir  26  with the concave first and second major surfaces  54 ,  64 . 
         [0033]      FIG. 3  is an end cross-sectional view of the reservoir  26 . The reservoir  26  includes sidewalls  70  that extend between the first and second major surfaces  54 ,  64 . In one embodiment, the sidewalls  70  are generally straight sidewalls that are parallel with the central longitudinal axis CL. In one embodiment, the sidewalls  70  generally curve between the first edge  52  and the second edge  62 . 
         [0034]    In one embodiment, the first surface  54  is concave and curves about a first longitudinal axis A 1  that is parallel with the central longitudinal axis CL, and the second surface  64  is concave and curves about a second longitudinal axis A 2  that is parallel to both the central longitudinal axis CL and the first longitudinal axis A 1 . 
         [0035]    In one embodiment, the first surface  54  is a top surface and the second surface  62  is a bottom surface, and the top and bottom surfaces  54 ,  64  each generally curve about a different axis that is parallel to the central longitudinal axis CL. 
         [0036]    In one embodiment, both of the first and second major surfaces  54 ,  64  are concave and extend between the sidewalls  70  (i.e., laterally) at a first radius of curvature and extend between the neck  40  and the end wall  50  (i.e., longitudinally as in  FIG. 2 ) with a concavity having a second radius of curvature. That is to say, each of the first and second major surfaces  54 ,  64  have a complex concave curvature. 
         [0037]      FIG. 4  and  FIG. 5  are prospective views of the reservoir  26  empty of liquid and in a configuration as provided to a surgical facility prior to implantation of the reservoir  26 . 
         [0038]      FIG. 4  is a top perspective view of the reservoir  26  illustrating the complex concave curvature of the first surface  54 . The various axes are illustrated to orient the reader; the central longitudinal axis CL extends through a point in an opening of the neck  40 , the first longitudinal axis A 1  is imposed above the reservoir  26  in a longitudinal direction, the second longitudinal axis A 2  is imposed below the reservoir  26  in a longitudinal direction, the first transverse axis TA 1  is imposed above the reservoir  26  in a transverse direction, and the second transverse axis TA 2  is imposed below the reservoir  26  in a transverse direction. In one embodiment, when the reservoir  26  is empty, the central longitudinal axis CL extends through a center of the opening of the neck  40 . 
         [0039]    The first surface  54  includes a first curvature extending between the end wall  50  and the neck  40  that curves about the first transverse axis TA 1  and a second curvature extending between the sidewalls  70  that curves about the first longitudinal axis A 1 . In one embodiment, the complex curvature of the first surface  54  is contained within the first edge  52  when the reservoir  26  is empty of liquid. The first edge  52  provides a flat surface extending around the perimeter of the reservoir  26 . The sidewalls  70  and the first and second edges  52 ,  62  smoothly blend into the neck  40 . 
         [0040]      FIG. 5  is a bottom perspective view of the reservoir  26  illustrating the complex concave curvature of the second surface  64 . The second surface  64  includes a first curvature extending between the end wall  50  and the neck  40  that curves about the second transverse axis TA 2  and a second curvature extending between the sidewalls  70  that curves about the second longitudinal axis A 2 . 
         [0041]    Each of the first surface  54  and a second surface  64  has a concave curvature when the reservoir  26  is empty of liquid. Embodiments provide the reservoir  26  with substantially equal concave curvature on each of the first surface  54  and the second surface  64 . In one embodiment, the depth of the curvature of the second surface  64  is deeper than the depth of the curvature of the first surface  54  ( FIG. 4 ) as illustrated in  FIG. 2 . 
         [0042]    In one embodiment, the first surface  54  is a top surface, and the second surface  64  is a bottom surface that is spaced apart from the top surface  54  by a distance equal to a height of the side wall  70 , and the top and bottom surfaces  54 ,  64  each generally curve about a different axis A 1 , A 2 , respectively, that is parallel to the central longitudinal axis CL. 
         [0043]      FIG. 6  is a side view of the reservoir  26  connected to the pump  22  by the tube  30  and filled with liquid. When the reservoir  26  is filled with liquid, the reservoir expands away from the central longitudinal axis CL. The first surface  54  expands away from the central longitudinal axis CL by the distance H 1  and a second surface  64  expands away from the central longitudinal axis by the distance H 2 . In one embodiment, the distance H 1  is substantially equal to the distance H 2 . In one embodiment, the distance H 1  is less than the distance H 2  and the reservoir  26  expands with a first surface expansion that is different from the second surface expansion. For example, in one embodiment the first surface expansion is less than the second surface expansion to allow the reservoir  26  to preferentially expand more in one direction (inward into the patient) than another direction (outward from the patient). That is, when the reservoir  26  expands, the first surface is less convex than the second surface is convex, relative to the central longitudinal axis. 
         [0044]      FIG. 7  is a schematic view of the penile prosthetic  20  implanted in a man. The pump  22  is implanted in the scrotum, each of the cylinders  32  is implanted into one of the corpora cavernosa, and the reservoir  26  is implanted within the patient. The pump  22  is connected to the reservoir  26  by the tube  30 , and the pump  22  is connected to the cylinders  32  by the tubes  34 . After implantation of the prosthetic  20 , the surgeon will evaluate function by filling the reservoir  26  with an amount of liquid, for example between 50-350 mL. Thereafter, the function of the prosthetic  20  is evaluated for inflation and deflation of the cylinders  32  and for an absence of leaking from the reservoir connections. The surgeon confirms acceptable performance of the prosthetic  20  prior to closing the surgical site. 
         [0045]    In one embodiment, the reservoir  26  is implanted in the space of Retzius behind the symphysis pubis. Thus, one acceptable location for implantation of the reservoir  26  is behind the pubic bone. 
         [0046]    In one embodiment, the reservoir  26  is implanted in the abdomen between muscle and fascia. For example, in one embodiment the reservoir  26  is implanted in front of the puborectalis muscle and behind the transversalis fascia. The concave curvature of the first and second surfaces  54 ,  64  provides the reservoir  26  with a compact (or flat) profile configured for discreet implantation into the wall of the abdomen. 
         [0047]    In one embodiment, the reservoir  26  is implanted subcutaneously anterior the fascia, one example of which is anterior to the transversalis fascia. 
         [0048]    In one embodiment, the reservoir  26  is implanted subcutaneously anterior to the abdominal muscle, one example of which is anterior to the puborectalis muscle. 
         [0049]    In one embodiment, the reservoir  26  is configured to provide differential expansion such that one of the major surfaces  54 ,  64  expands outward from the central longitudinal axis CL to a greater extent than the other major surface. As illustrated in  FIG. 7 , the second major surface  64  ( FIG. 6 ) is configured to expand more than the first major surface  54 , and the second major surface  64  is oriented to face posterior the patient such that the first major surface is oriented to face anterior the patient. When the reservoir  26  expands, the second major surface  64  expands inward into the user to reduce perception of the implanted reservoir, thus allowing the implanted reservoir  26  to be discreet even if implanted near the surface of the skin. 
         [0050]    Embodiments provide a reservoir having opposing concave depressions formed in the major surfaces that configure the reservoir with a low profile when implanted. The opposing concave depressions of the reservoir allow the reservoir to expand comfortably and discreetly when implanted and filled with liquid. Embodiments of the reservoir include differential concave surfaces that expand different amounts that configure the reservoir to expand more inwardly into the body than outwardly, for example, and this contributes to its discreet implanted profile. 
         [0051]    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.