Patent Abstract:
A method of implanting a penile prosthetic in a patient includes providing an implantable cylinder with a resorbable component attached to an exterior surface of the implantable cylinder and a tow line engaged with the resorbable component. The method includes inserting the tow line into a corpora cavernosum of a penis, directing the tow line through a glans of the penis, and pulling on the tow line and moving the implantable cylinder into the corpora cavernosum of the penis. The method includes locating a distal end of the implantable cylinder in a distal location in the corpora cavernosum of the penis, and disengaging the tow line from the resorbable component.

Full Description:
BACKGROUND 
       [0001]    An implanted penile prosthetic is effective in relieving erectile dysfunction in men. 
         [0002]    An inflatable penile prosthetic typically includes a cylinder that is implanted in each corpora cavernosum of the penis, a fluid reservoir, and a pump with valve mechanisms to move fluid from the reservoir to the cylinder to create an erection in the penis. Other penile prosthetics include a malleable cylinder without inflation fluid. 
         [0003]    Placement of a cylinder in the corpora cavernosum in a typical surgical procedure includes dilating the corpora cavernosum with a dilation tool to form an implant space sized to receive the cylinder. The cylinder is introduced into the implant space with a needle and a suture. One end of the suture is attached to the leading end of the cylinder and an opposite end of the suture is attached to a Keith needle. The Keith needle is directed through the glans penis and the cylinder is pulled distally towards the glans penis inside the corpora cavernosum. 
         [0004]    The above-described penile prosthetics have proven effective in relieving erectile dysfunction in men. However, improvements to penile prostheses would be welcomed by surgeons and patients alike. 
       SUMMARY 
       [0005]    One aspect provides a penile prosthetic including a cylinder that is implantable into a corpora cavernosum of a penis. A resorbable suture-engagement component is attached to an exterior surface of the cylinder. 
         [0006]    One aspect provides an implantable penile prosthetic system including a pump attachable between a reservoir and an inflatable cylinder. The cylinder is configured to be placed in a corpora cavernosum of a penis. A resorbable suture-engagement component is attached to an exterior surface of the cylinder. 
         [0007]    One aspect provides a penile prosthetic including a cylinder that is implantable into a corpora cavernosum of a penis, the cylinder having a wall that forms an exterior surface of the penile prosthetic. The wall extends from a proximal end portion to a distal end portion of the penile prosthetic. A suture-engaging component is attached to the exterior surface of the penile prosthetic. The suture-engaging component is resorbable into the tissue of the penis. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]    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. 
           [0009]      FIG. 1A  is a perspective view of one embodiment of a distal portion of a penile prosthetic including a resorbable suture-engaging component. 
           [0010]      FIG. 1B  is a perspective view of one embodiment of a penile prosthetic cylinder including a resorbable suture-engaging component. 
           [0011]      FIG. 1C  is another perspective view of the embodiment of  FIG. 1B  in which the resorbable suture-engaging component is engaged by a suture. 
           [0012]      FIG. 2A  is an enlarged part cross-sectional view of a distal end portion of the penile prosthetic illustrated in  FIG. 1A . 
           [0013]      FIG. 2B  is an enlarged end view of a distal end portion of the embodiment of  FIG. 2A . 
           [0014]      FIG. 3A  is perspective view of a distal end portion of one embodiment of the suture-engaging component having a strand of tow suture attached to a ring. 
           [0015]      FIG. 3B  is an enlarged part cross-sectional view of a ring attached to a distal end portion of one embodiment of a penile prosthetic. 
           [0016]      FIG. 3C  is perspective view of a distal end portion of one embodiment of the suture-engaging component in the form of a ring with two individual strands of tow suture attached to it. 
           [0017]      FIG. 3D  is an enlarged part cross-sectional view of a ring attached to a distal end portion of one embodiment of a penile prosthetic. 
           [0018]      FIG. 3E  is an enlarged part cross-sectional view of a distal end portion of one embodiment of a penile prosthetic. 
           [0019]      FIG. 4A  is an enlarged part cross-sectional view of a distal end portion of one embodiment of a penile prosthetic engaged by a suture. 
           [0020]      FIG. 4B  is an enlarged perspective view of one embodiment of a suture-engaging component. 
           [0021]      FIG. 5  is a perspective view of one embodiment of a penile prosthetic including a resorbable suture-engaging component and a tip component. 
           [0022]      FIG. 6  is an enlarged part cross-sectional view of a distal end portion of one embodiment of a penile prosthetic also showing a tip component and a suture. 
           [0023]      FIG. 7  is a perspective view of one embodiment of a penile prosthetic wherein the cylinder is malleable. 
           [0024]      FIG. 8  is a perspective view of one embodiment of a penile prosthetic system including a pump connected between a reservoir and a cylinder, the cylinder including a resorbable suture-engaging component. 
       
    
    
     DETAILED DESCRIPTION 
       [0025]    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. 
         [0026]    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. 
         [0027]    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. 
         [0028]    In this specification, “end” means endmost and “end portion” means that segment of a thing that is adjacent to and extends from the end. 
         [0029]    In this specification, “substantially constant” in relation to a wall thickness means that the wall is configured to have equal thickness over a given area or portion except for production tolerances or acceptable variations in dimensions. 
         [0030]    In this specification, “resorbable” characterizes a component or material that dissolves in body tissue of a patient over time. By “dissolves” is to be understood that the component or material is configured to lose its initial structural integrity and ceases to have significant coherence. In other words, once dissolved the component or material no longer provides a structural contribution to the penile prosthetic. The amount of time it takes for the component or material to dissolve is in dependency of the type of component or material and the dimensions thereof. It is useful if the component or material is dissolved at the end of a healing period after the implantation of the penile prosthetic. This will vary from patient to patient with different anatomies, but typically within 4-8 weeks post-surgery. 
         [0031]    Experience has shown that higher satisfaction with penile prosthetics including one or two cylinders is obtained if the characteristics of the cylinder do not alter noticeably over the extent of the cylinder. This is likely because any alteration in such characteristics changes the “feel” of the erection that may be sensed by the patient or his partner during sexual activity. Improvements to penile prosthetic cylinders are possible if an end portion of the cylinder located in the distal-most part of the corpora cavernosum, adjacent the glans penis, is “filled” as much as possible to optimally expand that part of the corpora cavernosum (the front of the penis is expanded to the widest girth possible). Patient feedback indicates that optimized filling of the distal part of the corpora cavernosum provides a more natural feel of the erection. Sometimes a tip-piece or similar is utilized to optimize filling of the distal-most part of the corpora cavernosum. 
         [0032]    Embodiments provide a penile prosthetic that is implantable into the corpora cavernosum of a penis. The penile prosthetic includes a cylinder and a resorbable suture-engaging component (RSEC). The RSEC attaches to an exterior surface of the cylinder. The RSEC is attachable to suture or a like material to assist the surgeon in implanting and adjusting the position of the cylinder in the corpora cavernosum. The RSEC is capable of subsequent biodegradation and absorption into the body of the patient, leaving the distal end portion of the cylinder unconstrained or unfettered by any form of a tip-piece. In embodiments wherein the cylinder in inflatable the unconstrained tip-piece of the cylinder expands as fully and naturally as the other portions of the cylinder to provide the user with a full and maximally expanded cylinder tip for improved girth and fullness in the area of the glans penis. 
         [0033]    The RSEC allows the surgeon to place the cylinder in the penis with a familiar surgical approach. For example, the surgeon checks that one end of a suture (a tow suture) is engaged with the RSEC. The tow suture is led in the distal direction through the penis glans so that it is possible for the surgeon to pull the tow suture externally of the penis and move the cylinder in the distal direction, i.e. towards the distal-most part of the corpora cavernosum. The tow suture is pullable to move the cylinder in the distal direction and adjust it to optimally locate in, and fill, the distal-most part of the corpora cavernosum. The RSEC ensures that it is possible to engage the tow suture with the cylinder without providing a permanent attachment feature that undesirably changes the characteristics of the prosthetic. 
         [0034]    Embodiments provide a penile prosthetic including a cylinder having a wall that forms an exterior surface of the penile prosthetic and extends from a proximal to a distal end of the penile prosthetic with an RSEC attached to the exterior surface. 
         [0035]    Embodiments provide a penile prosthetic including an RSEC, which will dissolve inside the corpora cavernosum during the post-surgery healing time. 
         [0036]    Embodiments provide a penile prosthetic that is easy to implant and adjust to optimally locate in and fill a distal-most part of the corpora cavernosum which provides an improved “feel” of the erection. 
         [0037]    Embodiments provide an implantable penile prosthetic system including a pump attachable between a reservoir and an inflatable cylinder configured to be placed in a corpora cavernosum of a penis. An RSEC is attached to an exterior surface of the cylinder. The inflatable cylinder of the system is configured to be easily located in and fill a distal-most part of the corpora cavernosum to provide an improved “feel” of the erection. 
         [0038]      FIG. 1A  is a perspective view of one embodiment of a penile prosthetic  20 . The penile prosthetic  20  includes a cylinder  22  and a resorbable suture-engaging component (RSEC)  24  is attached to an exterior surface  26  of the cylinder  22 . In one embodiment, the RSEC  24  attaches to a distal end portion  28  of the cylinder  22 . In one embodiment, the distal end portion  28  is located between an annular shoulder  30  and a distal end  32  of the cylinder  22 . In one embodiment, the penile prosthetic  20  includes a rear tip  21  attached to the cylinder  22  and tubing  27  extending from a tubing junction  25  in the rear tip  21 , as illustrated in  FIG. 1B .  FIG. 1C  shows another perspective view of a cylinder as in  FIG. 1B  in which a suture  42  is engaged with the RSEC  24 . 
         [0039]      FIG. 2A  is an enlarged partial cross-sectional view of a distal portion  23  of one embodiment of the penile prosthetic  20  having a maximum diameter D 1  of a main body portion  38  of the cylinder. In one embodiment, the RSEC includes a ring  34  attached annularly around the exterior surface  26  of the cylinder  22  and having a maximum outer diameter D 2 . In one embodiment, the ring  34  is offset a distance away from the distal end  32  of the cylinder  22 . The distance is at most three times the measurement of a maximum outer diameter D 3  of the distal end portion  28  of the cylinder  22 . In one embodiment, the distal end portion  28  tapers distally from the annular shoulder  30  in a direction towards distal end  32 , in which embodiment maximum diameter D 3  is measured where the distal end portion  28  meets annular shoulder  30 . In one embodiment, distal end portion  28  does not taper. In one embodiment, the ring  34  is attached to the exterior surface  26  at, or adjacent to, the annular shoulder  30 . In one embodiment, the ring  34  is attached to the exterior surface  26  in a location proximal to the annular shoulder  30 . In one embodiment, the ring  34  is attached to the exterior surface  26  distal to the annular shoulder  30 , i.e. on the distal end portion  28  of the cylinder  22 . 
         [0040]      FIG. 2B  is an enlarged end view of one embodiment of the distal portion  23  of the cylinder  22  as illustrated in  FIG. 2A . The RSEC includes a ring  34  attached annularly around the distal end portion  28  of the cylinder  22  adjacent annular shoulder  30 . For illustration purposes, in  FIG. 2B  a distance or space is visible between the ring  34  and the annular shoulder  30  indicating the ring  34  being in a location proximal to the annular shoulder  30 . However, as presented above the ring  34  may also be located distal to the annular shoulder  30  in which case no distance/space would be visible between the ring  34  and the annular shoulder  30 . In one embodiment, the distal end portion  28  of the cylinder  22  has a substantially constant thickness t. 
         [0041]      FIG. 3A  is a perspective view of a distal portion  23  of one embodiment of the penile prosthetic including a ring  34  attached to the cylinder  22  proximal to a distal end portion  28  of the cylinder. In one embodiment the ring  34  is engaged with a suture strand  42  extending through a pair of slots  50  provided in the ring with approximately 180 degrees of the ring between them. In one embodiment the ring  34  has a width and a thickness and defines and inner and an outer annular surface, the inner surface engaging with the cylinder  22 . 
         [0042]      FIG. 3B  is an enlarged part cross-sectional view of a distal portion of one embodiment of the penile prosthetic  20 . In one embodiment, distal portion  23  of the cylinder  22  includes a tapering segment  36  between an annular shoulder  30  and a main body portion  38  of the cylinder  22 . In one embodiment, a proximal-most end  40  of the tapering segment  36  is located at a distance L of no more than three times the measurement of a maximum outer diameter D 3  of the distal end portion  28  of the cylinder  22  (L≦3*D 3 ). In the embodiment of  FIG. 3B , the ring  34  is attached to the exterior surface  26  on tapering segment  36  within the distance L. Also shown is a suture  42  engaged with the RSEC  24 . In one embodiment, the suture  42  includes a bifurcated portion  44  and a line portion  46  that may be connected in a knot  48 . The bifurcated portion  44  includes arms  44 a, 44 b that each engage with the RSEC  24 . In one embodiment, the RSEC  24  is configured for bonding with one end of the length of suture  42 . In one embodiment, the bond may be releasable. In one embodiment, the bond may be removable. In one embodiment, one end of the length of suture  42  is molded into engagement with the RSEC  24 . In one embodiment, the RSEC  24  includes a slot  50  that receives and engages with a suture  42 . In one embodiment, the slot  50  extends through the RSEC  24 . In the embodiment shown, the suture  42  extends through one slot  50  and through another slot  50 . One advantage is that this allows for use of a single strand of tow suture. 
         [0043]    In one embodiment, shown in the perspective view of the distal portion  23  in  FIG. 3C , one end of the length of suture  42  goes through the slot  50  and is tied on one side of the slot in a knot or ball  51  that is large enough not to slip through the slot  50 . In one embodiment, the slot  50  in the resorbable material is configured to resorb quickly enough to allow for the knot or ball  51  to be pulled through the slot  50  for removal during the surgical procedure. In one embodiment, the length of suture  42  is engaged with the RSEC  24  during manufacture of the prosthetic. In one embodiment, the RSEC  24  is configured to be engaged with a suture by the surgeon or an assistant. 
         [0044]      FIG. 3D  is an enlarged partial cross-sectional view of a distal portion of one embodiment of the penile prosthetic  20 , in which the cylinder  22  does not include an annular shoulder such that tapering segment  36  transitions smoothly into distal end portion  28 . 
         [0045]      FIG. 3E  is an enlarged part cross-sectional view of a distal portion of one embodiment of the penile prosthetic  20 . The distal end portion  28  is attached directly to the main body portion  38  and has the same diameter as the main body portion  38  at the location of attachment. 
         [0046]      FIG. 4A  is an enlarged part cross-sectional view of a distal portion  23  of one embodiment of the penile prosthetic  20 . In one embodiment, the RSEC  24  includes a tip member  52  attached to the distal end portion  28  of the cylinder  22  (indicated in phantom line). The tip member  52  is resorbable. In one embodiment, the tip member  52  is attached to the distal end portion  28  by an adhesive. In one embodiment, the exterior surface  26  of the cylinder  22  is primed with a primer coating for adhesive attachment of the RSEC  24  to the cylinder  22 . In one embodiment, a proximal end  53  of the tip member  52  abuts the annular shoulder  30 . A suture  42  is shown engaging with the tip member  52  through a slot  50 . 
         [0047]      FIG. 4B  is an enlarged perspective view of one embodiment of RSEC wherein the tip member  52  is configured as a thimble-like structure having an interior surface  54  configured to attach annularly around the distal end portion  28  of the cylinder  22 . In one embodiment, the tip member  52  attaches to the cylinder  22  around less than an entirety of an exterior surface of the distal end portion  28 . In one embodiment, the tip member  52  includes a slot  50  to receive suture  42 . Other structures for receiving the suture and attaching it to the tip member  52  are acceptable including, but not limited to, an eye or a loop protruding from an exterior surface  56  of the tip member  52 . A wall thickness of the resorbable material of the tip member  52  is one parameter for determining the time it takes before the resorbable tip member  52  loses structural integrity and eventually dissolves in the patient&#39;s body. A thicker wall will take longer time to dissolve than a thinner wall. In one embodiment, a portion of the wall of the tip member  52  adjacent to an apex  58  of the tip member has an increased material thickness to accommodate the slot  50 . 
         [0048]    In one embodiment, the RSEC  24  is bonded to the exterior surface  26  of the cylinder  22 . In one embodiment, the RSEC is releasably bonded to the exterior surface  26  of the cylinder  22 . In one embodiment, the RSEC is removably bonded to the exterior surface  26  of the cylinder  22 . 
         [0049]      FIG. 5  is a perspective view of one embodiment of a penile prosthetic  20  including a cylinder  22  suitable for implantation into a corpora cavernosum of a penis. An RSEC  24  configured as a ring  34  is attached to an exterior surface  26  of the cylinder  22 . In one embodiment, the penile prosthetic  20  includes a tip component  60 . In one embodiment, the tip component  60  is manufactured from a silicone material. In one embodiment, the ring  34  is attached to the cylinder  22  proximal to the tip component  60 . The tip component  60  is useful for providing additional filling of the distal-most part of the corpora cavernosum. By using a silicone material for the tip component  60 , the gain in erection “feel” due to the additional filling is achieved with a soft material. This provides a penile prosthetic with no sudden change in characteristics and with a desirable softness of the penile prosthetic in the distal part of the corpora cavernosum adjacent or contacting the glans penis to the benefit of the erection feel for both the patient and his sexual partner. In one embodiment, the cylinder  22  has a uniform wall thickness T, i.e. the cylinder wall has the same thickness over its entirety. 
         [0050]      FIG. 6  is an enlarged part cross-sectional view of a distal portion  23  of one embodiment of a penile prosthesis  20 . In one embodiment, an RSEC including a ring  34  is attached to the cylinder  22  at the annular shoulder  30 . In one embodiment, a tip component  60  is attached to a distal end portion  28  of the cylinder  22  distal to the ring  34 . In one embodiment, a proximal end  62  of the tip component abuts the ring  34 . A suture  42  engaged with the ring  34  is shown extending in a distal direction from the ring  34 . 
         [0051]      FIG. 7  is a perspective view of one embodiment wherein the cylinder  22  is a malleable cylinder including a silicone elastomer shaft  70  and a silver wire coil  72  configured to be placed around a silver wire core  74  with a portion of the core and coil wrapped in a polymer  76  such as urethane and at least one other portion wrapped in a polymer such as a polyester or a polyethylene terephthalate. Both segments are over-molded with a silicone rubber. It is useful to apply a hydrophilic coating to the exterior surface of the silicone rubber. Suitable malleable cylinders are available from Coloplast Corp., Minneapolis, Minn. 
         [0052]      FIG. 8  is a perspective view of one embodiment of a penile prosthetic system  120  including a pump  180  connected between a liquid reservoir  182  and an inflatable cylinder  22 , the cylinder  22  including a resorbable suture-engaging component (RSEC)  24 . Tubing  184 , 186  connects the pump and the cylinders, and the pump and the reservoir, respectively. In one embodiment, the tubing  184  communicates with the inflatable cylinder  22  through a rear tip  21 . In one embodiment, the system  120  includes two individual inflatable cylinders  22 . Pressure on the pump  180  causes flow of liquid from the reservoir  182  to the cylinders  22  to create an erection in the penis. The pump  180  can include a valve activatable to release the liquid from the cylinders  22  to flow back to the reservoir  182 . 
         [0053]    In one embodiment, the cylinder of the penile prosthetic is inflatable. Suitable materials for fabricating the inflatable cylinder include silicone, polymers such as urethanes, blends of polymers with urethane, copolymers of urethane, or the like. Suitable inflatable cylinders are available from Coloplast Corp., Minneapolis, Minn. In one embodiment, the pump and the reservoir are fabricated from material suitable for body implantation, such as silicone or the urethane-based materials described above for the cylinder. 
         [0054]    In embodiments wherein the cylinder  22  is inflatable, using the RSEC  24  for the implantation procedure provides an additional advantage in the subsequent post healing time use of the prosthetic. The advantage includes that the distal end portion  28  is capable of the same level of expansion as the remaining part of the cylinder  22  because no permanent suture attachment feature is necessary near or at the distal end portion  28 . As the inflatable cylinder  22  is capable of expanding equally throughout its extent, the “feel” of the erection is more natural. Also, the part of the prosthetic located in the distal most part of the corpora cavernosum has the same characteristics as the rest of the prosthetic while better filling the space of the corpora cavernosum at, or adjacent to, the glans penis. 
         [0055]    Suitable materials for the resorbable suture-engaging component include polyester urethane (PEU), polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLLA), polydioxanone (PDO) and various copolymers of these. 
         [0056]    Attachment of the RSEC  24  to the cylinder  22  may be achieved in different ways, including adhesively bond the RSEC  24  onto the cylinder by a solvent bond or using a PU adhesive in embodiments wherein the cylinder too is manufactured from a PU. In one embodiment, the RSEC  24  is directly built up from resorbable PEU liquid precursors on the PU surface of the cylinder instead of the RSEC  24  being separately provided and attached. In one embodiment, the RSEC  24  is provided as a ring  34  that is mechanically adhered by making an inner diameter of the ring  34  slightly smaller than an outer diameter of the cylinder  22  (at the desired location of attachment). By application of a solvent to the ring, the ring swells which allows it to be placed around the cylinder surface. When the solvent vaporizes the ring shrinks back down and adheres through mechanical and Van der Waals forces. 
         [0057]    Embodiments have been described in which a penile prosthetic includes a resorbable component for engagement with a suture used to tow the penile prosthetic distally into the corpora cavernosum of a penis. The resorbable component dissolves over the post-surgery heal time and provides for the penile prosthetic to be easily locatable and adjustable without necessitating permanent suture attachment features on the prosthetic to enable the surgeon to pull the prosthetic distally. This in turn ensures a penile prosthetic with little or no influence on the characteristics over the longitudinal extent of the surface of the penile prosthetic. 
         [0058]    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.

Technology Classification (CPC): 0