Penile prosthesis devices and methods

• US 20050075534A1
• Filed: 10/01/2004
• Published: 04/07/2005
• Est. Priority Date: 10/02/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Kuyava, Charles C.
• Granted Patent: US 7,407,482 B2
• Time in Patent Office: Days
• US Class Current: 600/38
• CPC Class Codes: A61F 2/26 Penis implants

Abstract

Penile implant devices and methods are disclosed. A penile implant device in accordance with the present invention includes an implantable penile prosthesis pre-connected to a needle by a suture. The needle and suture may also be at least partially enclosed in a sheath or the like. In accordance with the present invention, a penile prosthesis is connected to a needle by a suture during a pre-operative storage period of the penile implant device. For example, the penile prosthesis may be connected to the needle during manufacture of the penile implant device.

Claims

1. A penile implant device that can be implanted in a penis of a patient for the treatment of impotence, the penile implant device comprising:

a penile prosthesis that can be implanted in a corpus cavernosa of a penis;

a needle having a piercing end and a connecting end; and

a suture connected to a first end of the penile prosthesis and pre-connected to the connecting end of the needle during manufacture of the penile implant device.

2. The penile implant device of claim 1, wherein at least a portion of the suture is threaded through an eye at the connecting end of the needle and tied to the connecting end of the needle.

3. The penile implant device of claim 1, wherein the suture is threaded through an eye at the connecting end of the needle and comprises first and second suture portions tied together to form a knot.

4. The penile implant device of claim 3, wherein the knot is non-movably positioned adjacent to the eye of the needle.

8. The penile implant device of claim 1, wherein the needle comprises a non-straight portion between the piercing end and the connecting end of the needle.

9. The penile implant device of claim 8, wherein the non-straight portion of the needle comprises an engaging portion that can resistively engage with at least a surface portion of the sheath.

5. A penile implant device that can be implanted in a penis of a patient for the treatment of impotence, the penile implant device comprising:

a penile prosthesis that can be implanted in a corpus cavernosa of a penis;

a needle having a piercing end and a connecting end;

a suture connected to a first end of the penile prosthesis and connected to the connecting end of the needle; and

a sheath at least partially covering at least a portion of the needle and at least a portion of the suture.

6. The penile implant device of claim 5, wherein the sheath comprises at least a surface portion that resistively engages with at least a portion of the needle.

7. The penile implant device of claim 5, wherein the sheath comprises at least a surface portion that resistively engages with at least a portion of the suture.

10. The penile implant device of claim 5, wherein the suture comprises polyethylene.

11. A penile implant device kit that can be provided by a manufacturer to a surgeon, the penile implant device kit comprising:

a penile prosthesis that can be implanted in a corpus cavernosa of a penis;

a needle having a piercing end and a connecting end; and

a suture connected to a first end of the penile prosthesis and connected to the connecting end of the needle.

12. The penile implant device kit of claim 11, further comprising a second penile prosthesis connected to a needle by a suture.

13. The penile implant device kit of claim 12, further comprising a fluid reservoir operatively connected to the first and second penile prostheses.

14. The penile implant device kit of claim 11, further comprising a sheath covering at least a portion of the needle.

15. A method of making a penile implant device that can be implanted in a penis of a patient for the treatment of impotence, the method comprising the steps of:

providing a penile prosthesis having an end that can be implanted in a corpus cavernosa of a penis and a needle having a piercing end and a connecting end;

connecting a suture to the end of the penile prosthesis;

connecting the suture to the connecting end of the needle; and

maintaining the connection of the suture to the connecting end of the needle during at least a pre-operative storage period of the penile implant device.

16. The method of claim 15, wherein the step of connecting the suture to the end of the penile prosthesis comprises threading the suture through the end of the penile prosthesis so that first and second portions of the suture extend from the end of the penile prosthesis.

17. The method of claim 16, wherein the step of connecting the suture to the connecting end of the needle comprises threading at least one of the first and second suture portions through an eye at the connecting end of the needle.

18. The method of claim 17, wherein the step of connecting the suture to the connecting end of the needle comprises tying the first and second suture portions together to form a knot.

19. The method of claim 15, further comprising the step of positioning at least a portion of the needle inside a sheath.

20. The method of claim 19, wherein the step of positioning at least a portion of the needle inside a sheath comprises resistively engaging at least a portion of an inside surface of the sheath with at least a portion of the needle after connecting the suture to the connecting end of the needle.

21. The method of claim 15, further comprising the step of positioning at least a portion of the suture inside a sheath.

22. The method of claim 21, wherein the step of positioning at least a portion of the suture inside a sheath comprises resistively engaging at least a portion of an inside surface of the sheath with at least a portion of the suture after connecting the suture to the connecting end of the needle.

23. The method of claim 15, further comprising the step of packaging the penile prosthesis connected to the needle for storage during a pre-operative storage period of the penile implant device.

24. A method of implanting a penile prosthesis of a penile implant device in a penis of a patient for the treatment of impotence, the method comprising the steps of:

providing a penile implant device comprising a penile prosthesis that has been connected to a needle by a suture during a pre-operative storage period of the penile implant device;

positioning the needle and at least a portion of the suture in a corpus cavernosa of a penis, piercing the glans of the penis with the needle, and drawing at least a portion of the suture through the glans of the penis with the needle; and

positioning the penile prosthesis in the corpus cavernosa of the penis.

25. The method of claim 24, wherein the step of providing a penile implant device comprises removing the penile implant device from a package that the penile implant device has been stored in during the pre-operative storage period of the penile implant device.

26. The method of claim 24, wherein the step of providing a penile implant device comprises providing a penile prosthesis connected to a needle by a suture wherein at least a portion of the needle and suture are enclosed in a sheath.

27. The method of claim 26, further comprising the step of removing the sheath before implanting the penile prosthesis in the penis.