Implantable penile prosthesis

• US 5,263,981 A
• Filed: 04/24/1992
• Issued: 11/23/1993
• Est. Priority Date: 04/24/1992
• Status: Expired due to Term

• Current Assignee: Ams Research Corporation (Endo International PLC)
• Original Assignee: American Medical Systems Incorporated (Endo International PLC)
• Inventors: Pugh, Robert W. Jr., Polyak, Mark
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US07/873,473
• Time in Patent Office: 578 Days
• Field of Search: 128/79, 128/DIG. 25, 623/10, 623/11, 623/8
• US Class Current: 623/23.67
• CPC Class Codes: A61F 2/26 Penis implants

Abstract

A penile prosthesis for alleviating erectile impotency includes a generally tubular enclosure which is implantable within the corpus cavernosum. The tubular enclosure includes a generally non-distensible pressurizable chamber which when filled with fluid substantially to capacity will transform the prosthesis from the flaccid to an erect state, and a unique inflation valve assembly comprising two valves in longitudinally sequential relationship which will open or close under sequentially applied pressure differential conditions. The prosthesis includes a pump implantable in the body apart from the tubular enclosure, preferably in the scrotum, and a deflation valve.

Claims

1. A penile prosthesis having a generally tubular enclosure having a proximal portion and a distal portion implantable within a corpus cavernosum of the penis, said tubular enclosure comprising:

a generally tubular non-distensible pressurizable chamber having an interior volume defined substantially medially within said enclosure, said prosthesis being transformable from a flaccid to an erect state when the interior volume of said pressurizable chamber is filled with fluid substantially to capacity;

a fluid containing reservoir defined within the proximal portion of said enclosure;

an inflation assembly comprising two valves in longitudinally sequential relationship, said valves having means for opening and closing under sequentially applied pressure differential conditions, said assembly being disposed between the pressurizable chamber and the reservoir;

and a deflation valve defined within the distal portion of said enclosure, adjacent to the pressurizable chamber;

said prosthesis also including a pump bulb which is adapted to be implanted separate from said enclosure and in a part of the body apart from the penis, said pump bulb being in fluid communication with said inflation assembly through a passageway exiting into said inflation assembly at a location between said two inflation valves of said inflation assembly;

whereby to inflate the prosthesis the pump bulb is sequentially squeezed and released so that fluid will flow from the pump bulb to the pressurizable chamber, from the reservoir back to the pump bulb, and back again to the pressurizable chamber until the latter is filled to capacity causing the prosthesis to assume the erect state.

3. A penile prosthesis in accordance with claim 1, wherein the pump bulb is adapted to be implanted within the scrotum.

4. A penile prosthesis in accordance with claim 3, wherein the tubular enclosure comprises a proximal portion, a distal portion, and a medial portion, having an outer layer wherein the outer layer of said medial portion has a corrugated configuration.

5. A penile prosthesis in accordance with claim 4, wherein the corrugated configuration of the outer layer of the medial portion defines a series of passageways or channels permitting the flow fluid from the deflation valve to the reservoir.

6. A penile prosthesis in accordance with claim 4, wherein the distal portion is substantially rigid.

7. A penile prosthesis in accordance with claim 4, wherein the pressurizable chamber includes a substantially non-distensible tubular portion, and a tubular sleeve concentric with said tubular portion, and wherein said tubular sleeve contains channels which permit the flow of fluid during deflation from the pressurizable chamber back to the reservoir.

2. A penile prosthesis having a generally tubular enclosure having a proximal portion and a distal portion implantable within a corpus cavernosum of the penis, said tubular enclosure comprising:

a generally tubular non-distensible pressurizable chamber having an interior volume defined substantially medially within said enclosure, said chamber being transformable from a flaccid to an erect state when the interior volume of said chamber is filled with fluid substantially to capacity;

a fluid containing reservoir defined within the proximal portion of said enclosure;

an inflation assembly disposed between the pressurizable chamber and the reservoir and comprising two valves in longitudinally sequential relationship, said valves having means for opening and closing under sequentially applied pressure differential conditions, said means for each valve comprising a normally tightly fitting but distensible sleeve which in a closed mode will be compressed on a rigid portion of the inflation assembly, but in an open mode will enable fluid to pass around said portion from an adjacent chamber;

and a deflation valve defined within the distal portion of said enclosure, adjacent to the pressurizable chamber;

said prosthesis also including a pump bulb for implantation separate from the tubular enclosure, said pump bulb being in fluid communication with said inflation assembly through a passageway exiting into said inflation assembly at a location between said two inflation valves of said inflation assembly;

whereby when said pump bulb is sequentially squeezed and released fluid will flow from the pump bulb to the pressurizable chamber, from the reservoir back to the pump bulb, and back again to the pressurizable chamber until the latter is filled to capacity causing the prosthesis to assume the erect state.

8. A penile prosthesis having a generally tubular enclosure having a proximal portion and a distal portion implantable within a corpus cavernosum of the penis, said tubular enclosure comprising:

a generally tubular non-distensible pressurizable chamber having an interior volume defined substantially medially within said enclosure, said chamber being transferable from a flaccid to an erect state when the interior volume of said chamber is filled with fluid substantially to capacity;

a fluid containing reservoir defined within the proximal portion of said enclosure;

an inflation assembly between the pressurizable chamber and the reservoir comprising two valves in longitudinally sequential relationship adapted to open and close under sequentially applied pressure differential conditions, said assembly also including an inflation chamber circumferentially disposed about a stiffener, the stiffener extending throughout most of said proximal portion, the valves comprising a front check valve consisting of a sleeve normally tightly affixed to the stiffener which will distend and thereby open when the pressure of the inflation chamber exceeds that of the pressurizable chamber and will close when the pressure of the pressurizable chamber exceeds that of the inflation chamber, and a rear check valve which consists of a sleeve normally tightly affixed to the stiffener which will distend and thereby open when the fluid pressure in the reservoir exceeds that of the inflation chamber and will close when the pressure of the inflation chamber exceeds or is equal to that of the reservoir;

and a deflation valve defined within the distal portion of said enclosure, adjacent to the pressurizable chamber;

said prosthesis also including a pump bulb for implantation separate from the tubular enclosure, said pump bulb being in fluid communication with said inflation assembly through a passageway exiting into said inflation assembly at a location between said two inflation valves of said inflation assembly;

whereby when said pump bulb is sequentially squeezed and released fluid will flow from the pump bulb to the pressurizable chamber, from the reservoir back to the pump bulb, and back again to the pressurizable chamber until the latter is filled to capacity causing the prosthesis to assume the erect state.

9. A penile prosthesis having a generally tubular enclosure having a proximal portion and a distal portion implantable within a corpus cavernosum of the penis, said tubular enclosure comprising:

a generally tubular non-distensible pressurizable chamber having an interior volume defined substantially medially within said enclosure, said chamber being transferable from a flaccid to an erect state when the interior volume of said chamber is filled with fluid substantially to capacity;

a fluid containing reservoir defined within the proximal portion of said enclosure;

an inflation assembly between the pressurizable chamber and the reservoir comprising two valves in longitudinally sequential relationship adapted to open and close under sequentially applied pressure differential conditions, said assembly also including an inflation chamber circumferentially disposed about a stiffener, the stiffener extending throughout most of said proximal portion, the valves comprising a front check valve consisting of a sleeve normally tightly affixed to the stiffener which will distend and thereby open when the pressure of the inflation chamber exceeds that of the pressurizable chamber and will close when the pressure of the pressurizable chamber exceeds that of the inflation chamber, and a rear check valve which consists of a sleeve normally tightly affixed to the stiffener which will distend and thereby open when the fluid pressure in the reservoir exceeds that of the inflation chamber and will close when the pressure of the inflation chamber exceeds or is equal to that of the reservoir;

and a deflation valve for returning said pressurizable chamber from the erect to flaccid state, said valve being in fluid communication with said pressurizable chamber and said reservoir, said valve comprising closure means for normally keeping the valve in a closed mode, means for time-deferring the transfer of fluid within said valve thereby effecting a change in the internal pressure conditions within said valve, and a movable partition disposed within a distensible chamber within said valve capable of exerting sufficient force upon said closure means as a consequence of said change in internal pressure conditions, to place said valve in an open mode necessary to cause deflation;

said prosthesis also including a pump bulb for implantation separate from the tubular enclosure, said pump bulb being in fluid communication with said inflation assembly through a passageway exiting into said inflation assembly at a location between said two inflation valves of said inflation assembly;

whereby when said pump bulb is sequentially squeezed and released fluid will flow from the pump bulb to the pressurizable chamber, from the reservoir back to the pump bulb, and back again to the pressurizable chamber until the latter is filled to capacity causing the prosthesis to assume the erect state.

10. A penile prosthesis in accordance with claim 9, wherein said deflation valve for returning said chamber section from the erect to flaccid state comprises a housing having defined therewithin:

closure means comprising a poppet having a head and shaft, and including means for exerting a force upon said poppet head for normally keeping the sealing edge thereof in sealing contact with the inner surface of said housing;

said poppet head being disposed within a chamber containing fluid, said chamber being in fluid communication with said pressurizable chamber, the fluid pressure in said chamber and said means for exerting a force upon said poppet head normally keeping the closure means and thereby the valve mechanism in a closed mode;

a movable partition capable of impacting upon said poppet;

and a further distensible chamber adjacent to said partition, said chamber being in fluid communication with the chamber disposed about the poppet head through means which time-defer the transfer of fluid between said chambers;

whereby under precalibrated pressure conditions fluid pressure in said further chamber will distend said partition to exert sufficient force upon said poppet to break the sealing contact of said poppet head with said housing, thereby placing the valve mechanism in an open mode, whereby fluid from said tubular pressurizable chamber will flow into the chamber disposed about the poppet head and then into said fluid reservoir thereby deflating said tubular chamber section and returning said section to its flaccid state.

11. A penile prosthesis in accordance with claim 10, wherein to effect said precalibrated pressure differential conditions within the deflation valve the pressurizable chamber section is initially bent to a predetermined extent so that the fluid pressure in the chamber disposed about the poppet head is sharply increased, and is then quickly returned to its unbent position so that the fluid pressure in the chamber disposed about the poppet head is sharply decreased back to its original pressure, but wherein because of the time-delay occasioned by the means which transfers the flow of fluids to and from said latter chamber to the chamber disposed adjacent to the distensible partition, the pressure of the latter chamber is differentially higher than that of the chamber disposed about the poppet head, said higher pressure thereby distending the partition and causing it to impact upon the poppet thereby opening said deflation valve.

12. A penile prosthesis in accordance with claim 11, wherein the means which time-defer the transfer of fluid between the chamber disposed about the poppet head and the further chamber disposed adjacent to the distensible partition comprises fluid resistor means, and the distensible partition is a distensible diaphragm.

13. A penile prosthesis in accordance with claim 12, wherein the pump bulb is adapted to be implanted within the scrotum.