Abstract:
A subcutaneous prosthesis for a penis provides two sides of an elongated cylinder, the sides hinged along a top longitudinal edges of the sides. One end of the prosthesis has a gauze sheath providing a means to secure the prosthesis from moving relative to the corpora cavernosa around which it is placed. When the penis is erect it grows in girth thereby causing the two sides of the cylindrical prosthesis to spread divergently and forcing a press-rib against the deep dorsal vein of the penis, thereby restricting blood flow.

Description:
BACKGROUND OF THE INVENTION 
     Field of the Invention 
     This invention relates generally to surgical prostheses for the enhancement of appearance and operation of organs, and more particularly to a penile prosthesis enabling a damaged penis or poor penis function to be restored to a satisfactory sexual function. 
     Description of Related Art 
     A prosthesis for implantation into a penis to provide rigidity and improve dimensions is known in the art. Such a prosthesis may include an elongated, malleable rod portion which is housed within a generally tubular, physiologically inert plastic body. The malleable rod portion enables the prosthesis to conform to a variety of shapes by bending or twisting it. During intercourse the prosthesis will maintain the penis in an erect state, and afterwards the penis may be positioned and maintained in a more convenient and comfortable position. Finney, U.S. Pat. No. 4,204,530 describes a prosthesis with a sleeve for increasing the penile diameter, and which includes a flexible sheet of soft, physiologically acceptable material, the sheet being of sufficient length when formed in the general shape of a cylindrical sleeve to extend from the glans penis to the base of the penis and of a width which is insufficient to completely encircle the penis, but is sufficient to cover the corpora cavernosa. Improved rod-type penile prostheses may have a relatively stiff proximal portion for positioning inside the corpora cavernosa adjacent the pubis for supporting the prosthesis, a longer relatively stiff distal portion for positioning in the corpora cavernosa of the pendulous penis, and a hinge separating the distal and proximal portions. Masters, U.S. Pat. No. 4,669,456 describes a penile prosthesis which comprises an elastomeric rod and a metal wire coil coaxially imbedded within at least a portion of the rod. Subrini, U.S. Pat. No. 6,015,380 describes a prosthesis which can be used to increase penile volume. Moreira de Azeredo, WO 86/01398 describes a penile rigidity prosthesis for the treatment of erectile impotence in men including at least one penile prosthesis comprising an elongated malleable cylindrical body adapted to be surgically placed in the corpora cavernosa. 
     The prior art teaches the use of a subcutaneously placed prostheses to rigidize the penis, but does not teach the use of certain contours that provide structural advantages nor a means for restricting flow through the dorsal vein, or a means for preventing axial movement or sliding of the prosthesis relative to the penis&#39; long axis. The present invention fulfills these needs and provides further related advantages as described in the following summary. 
     SUMMARY OF THE INVENTION 
     The present invention teaches certain benefits in construction and use which give rise to the following objectives. A penile prosthesis may have a cylindrical, elongated body providing a wall thickness varying circumferentially from a maximum thickness at its top surface, to a minimum thickness along its bottom surface. The wall thickness may further vary longitudinally from a maximum thickness at a proximal end of the device to a minimum thickness at a distal end. The apparatus is preferably made of silicone rubber and has a length and size enabling subcutaneous implantation around the corpora cavernosa providing sufficient rigidity for enabling coitus while still being flexible enough to be conveniently positioned when the penis is flaccid. 
     An objective of the described and claimed prosthesis is to provide rigidity to the human penis so as to enable coitus. 
     A further objective is to provide an appropriate tapered appearance. 
     A still further objective is to enable surgical implantation without removal of existing organ portions or related tissues. 
     A yet further objective is to prevent the prosthesis from moving axially after being implanted. 
     A further objective is to provide a means for anchoring the distal end of the prosthesis. 
     An important objective is to stem the flow of blood out of the penis during coitus. 
     Other features and advantages of the present invention will become apparent from the following more detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings illustrate the present invention. In such drawings: 
         FIG. 1  is a perspective view of the described and illustrated prosthesis; 
         FIG. 2  is a perspective view of a left half thereof; 
         FIG. 3  is a perspective view of a gauze sheath thereof; 
         FIG. 4  is a side elevation view thereof; 
         FIG. 5  is a rear elevation view thereof; 
         FIG. 6  is a distal elevation view thereof; 
         FIG. 7  is a proximal elevation view thereof shown with a flaccid penis; 
         FIG. 8  is a further proximal elevation view thereof shown with engorged penis; and 
         FIG. 9  is a cross-sectional view of the human penis. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The above described drawing figures illustrate the invention in at least one of its preferred embodiments, which is further defined in detail in the following description. 
     The invention is a penile prosthesis, of silicone rubber or an equivalent material, which may be implanted subcutaneously in the human penis  5 .  FIG. 9  is a section illustrating the anatomy of penis  5  and showing in particular, the dorsal vein  6   a , the deep dorsal vein  6   b , the dorsal artery and nerve  6   c , the corpus cavernosum penis  6   d , the profunda artery  6   e , the corpus spongiosum and urethra  6   f , the tunica albuginea  6   g , the intercavernous septum of buck&#39;s fascia  6   h , the tunica albuginea of corpus caversosum penis  6   i , the buck&#39;s fascia  6   j , the dartos fascia  6   k , and the skin  6   l  which is the outer layer of penis  5 . 
     The prosthesis may have a cylindrical body  10  of a selected longitudinal length aligned with the long axis  4  of penis  5 , and may be open at both its proximal end  20  (nearest to the testacies), as well as at its opposite distal end  30  (nearest to the glans penis) as shown in  FIG. 1 . Body  10  may have an inside surface  50  and an outside surface  60  and may be formed as a single integral part with two joined halves  10 A,  10 B or alternately it may be formed as two separate halves  10 A,  10 B which may be later joined together as shown in  FIG. 1 . Halves  10 A,  10 B may be mirror images of each other as shown and may be joined prior to or during implantation into penis  5 . The prosthesis implantation process is taught in Finney, U.S. Pat. No. 4,202,530 which is hereby incorporated into the present application by reference. Thus, it is clear that the prosthesis can be formed to have a size and shape adapted for subcutaneous implantation below exterior skin  6   l  and adjacent to buck&#39;s fascia  6   h . The prosthesis may extend from the base of penis  5  at its proximal end  20  to the glans penis (not shown) at distal end  30 . Both inside surface  50  and outside surface  60  may have a silicon net sheeting  70  imbedded just under these surfaces as shown in  FIGS. 1 and 2 , wherein net sheeting  70  may extend continuously over and/or under both halves  10 A,  10 B and thus function as a hinge between the halves along joining line  100 . Halves  10 A and  10 B may therefore move between the two attitudes shown in  FIGS. 7 and 8 . The prosthesis, when in place around buck&#39;s fascia  6   j , may be anchored using sutures joining net sheeting  70  to buck&#39;s fascia  6   j  or to tunica albuginea  6   g , or both. 
     As shown in  FIGS. 1 and 2 , a press-rib  15 , of silicone rubber or equivalent material, may be joined to body  10  and, or to net sheeting  70 , or both, along joining line  100 . Press-rib  15  may extend only partially or fully over the length of body  10 . The hardness of the material of press-rib  15  is selected to be effective in the compressing action shown in  FIG. 8 . The function of press-rib  15  will be discussed below in conjunction with descriptions of  FIGS. 6-8 . 
     Body  10  may have a wall thickness that varies circumferentially from a maximum thickness along joining line  100  in  FIG. 1 , to a minimum thickness along bottom edges  90 . It should be clear that  FIG. 1  represents body  10  when the two halves  10 A,  10 B are joined along joining line  100 . The wall thickness of body  10  further may vary longitudinally from a maximum thickness at proximal end  20 , to a minimum thickness at distal end  30 . Edges  90  may be spaced apart as shown in  FIGS. 1 and 6-8  and this gap may extend the full length of body  10 . 
     The thicker wall at proximal end  20 , when placed adjacent to the base of the penis provides the advantage of improved rigidity of the prosthesis, and the thinner wall at distal end  30 , adjacent to the glans penis, allows for improved movement of the glans penis. The uniform taper from proximal end  20  to distal end  30  provides improved flexibility of the penis when flaccid. The thicker wall along joining line  100  provides greater structural strength where the highest compressive forces occur during coitus. The circumferential taper provides improved flexibility of the penis and a more natural penile conformation and appearance as well as improved blood flow in general since the prosthesis wall may be quite thin near the glans penis. The important overall result of the conformation of the prosthesis is that it uses a relatively small amount of material while achieving sufficient rigidity and blood flow. The use of net sheeting  70  provides a wide range of choices as to placement of sutures. The use of split halves  10 A, and  10 B facilitates implantation and provides the opportunity to use asymmetrical halves as may be necessary for repair of damaged or misshaped organs. The space between the bottom longitudinal edges  90  allows the penis to expand without restraint, see  FIG. 8 . 
     The interior space within body  10  is preferably oblate, as is the human penis  5  with height greater than width as shown in  FIGS. 6 and 7  with a preferred ratio of height to width of approximately 1.12. It has been found that this form enables improved blood flow as well as a more comfortable fit to the shape of the penis. 
     As shown in  FIG. 1 , body  10  may be fitted with a gauze sheath  110  at distal end  30  and it may be fixed thereto by sutures  112  as also shown.  FIGS. 3-5  show that gauze sheath  110  may have the same shape as the distal end  30  of body  10  so that gauze sheath  110  may be fitted up against the terminal edge of distal end  30  and may lay against both inner surface  50  as well as outer surface  60  of body  10  so that it does not produce a bulky area adjacent to the glans penis and provides an improved implantation. Gauze sheath  110  provides a functional means for suturing the distal end  30  of body  10  to the buck&#39;s fascia  6   h  so that body  10  is unable to move longitudinally. 
       FIG. 6  shows the prosthesis as viewed from the distal end  30  looking toward the proximal end  20  while  FIGS. 7 and 8  show the prosthesis as viewed from the proximal end  20  looking toward the distal end  30  and additionally show buck&#39;s fascia  6   h  in dashed outline. Skin  6   l  is not shown in  FIG. 6, 7 , or  8 . Deep dorsal vein  6   b  is shown located at the 12 o&#39;clock position (under joining line  100 ) in  FIGS. 7 and 8 , whereas  FIG. 7  represents a flaccid penis  5  while  FIG. 8  represents an erect or engorged penis  5 . It is shown that press-rib  15  compresses deep dorsal vein  6   b  to slow outward blood flow during the erection process and in order to maintain the erect condition. 
     While the invention has been described with reference to at least one preferred embodiment, it is to be clearly understood by those skilled in the art that the invention is not limited thereto. Rather, the scope of the invention is to be interpreted only in conjunction with the appended claims.