Parylene-coated components for inflatable penile prosthesis

• US 6,558,315 B1
• Filed: 03/15/2000
• Issued: 05/06/2003
• Est. Priority Date: 03/15/2000
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Kuyava, Charles C.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/526,051
• Time in Patent Office: 1,147 Days
• Field of Search: 600/38-41, 623/11-12, 623/901
• US Class Current: 600/40
• CPC Class Codes: A61F 2/26 Penis implants
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: C08L 65/04 Polyxylenes

Abstract

A penile prosthesis beneficially includes components coated with parylene in order to increase product life and reduce wear. In particular, components of the inflatable cylinder benefits from having been coated with parylene. The parylene-coated cylinder components are resistant to wear generated by pinching of the cylinder when the cylinder is in a flaccid state. The parylene-coated cylinder may be formed by masking a tube of silicone (or other appropriate material) and vapor coating the silicone tube with parylene. Further, where a double walled cylinder is used, each of two tubes making up the double wall cylinder can have their surfaces coated with parylene, thus increasing cylinder life and avoiding wear.

Claims

1. A multi-component penile prosthesis comprising one or more components having flexible expanding and contracting surfaces coated on at least one contacting surface with a parylene material adapted to a) expand and return to an original configuration, b) reduce the coefficient of friction of the contacting surface, and c) prevent or inhibit wear or degradation of the flexible expanding and contracting surface at bend corners or pinch points of crease lines associated with folding or bending of the one or more components.

2. The penile prosthesis of claim 1 comprising a flexible cylinder coated on both an inner surface and an outer surface with parylene.

3. The penile prosthesis of claim 1 wherein the entire inner and outer surfaces of the components arc coated with parylene material.

4. The penile prosthesis of claim 1 wherein a portion of the components are uncoated while the remainder of the inner and outer surfaces of the components are coated with parylene material.

5. The penile prosthesis of claim 1, further comprising:

a flexible fluid passageway coupling a pump and valve assembly to a flexible cylinder, wherein the fluid passageway is at least partially coated with parylene.

6. The penile prosthesis of claim 1, further comprising:

a flexible reservoir tube coupling a reservoir to a pump and valve assembly, wherein the reservoir tube is at least partially coated with parylene.

7. The penile prosthesis of claim 2 wherein the cylinder is made of silicone.

8. The penile prosthesis of claim 2 wherein the cylinder is made of polyurethane.

9. The penile prosthesis of claim 6 wherein the reservoir is at least partially coated with parylene.

10. The penile prosthesis of claim 5 wherein the pump and valve assembly is at least partially coated with parylene.

11. The penile prosthesis of claim 2 wherein the cylinder further comprises a front and rear end cap.

12. The penile prosthesis of claim 11 wherein the front and rear end cap are coated with parylene.

13. The penile prosthesis of claim 1, wherein the coating is parylene between 0.00004″

-0.000120″

thick.

14. The penile prosthesis of claim 1, wherein the coating is parylene between 0.00004″

-0.00008″

thick.

15. The penile prosthesis of claim 1, wherein the coating is parylene about 0.00006″

thick.

16. The penile prosthesis of claim 1 comprising a reservoir and at least one flexible cylinder formed as a single, integral assembly.

17. A penile prosthesis component comprising an inflatable, flexible expanding and contracting cylinder wherein the cylinder is coated on at least one contacting surface with a parylene material adapted to a) expand and return to an original configuration, b) reduce the coefficient of friction of the contacting surface, and c) prevent or inhibit wear or degradation of the flexible expanding and contracting cylinder at bend corners or pinch points of crease lines associated with folding or bending of the cylinder.

18. The penile prosthesis of claim 17 wherein the cylinder is coated on both an inner and outer surface.

19. The penile prosthesis of claim 17 wherein the entire inner and outer surface of the cylinder is coated.

20. The penile prosthesis of claim 17 wherein a portion of the cylinder is uncoated while the remainder of the inner and outer surfaces of the cylinder are coated.

21. The penile prosthesis of claim 17, further comprising:

a fluid passageway coupling a pump and valve assembly to the cylinder, wherein the fluid passageway is at least partially coated with the material.

22. The penile prosthesis of claim 17, further comprising:

a reservoir tube coupling a reservoir to a pump and valve assembly, wherein the reservoir tube is at least partially coated.

23. The penile prosthesis of claim 22 wherein the reservoir is at least partially coated with the material.

24. The penile prosthesis of claim 17 wherein the cylinder is made of silicone.

25. The penile prosthesis of claim 17 wherein the cylinder is made of polyurethane.

26. The penile prosthesis of claim 17 wherein the cylinder further includes a front and rear end cap.

27. The penile prosthesis of claim 23 wherein the front and rear end cap are coated with parylene.

28. A method of making a wear resistant cylinder for a penile prosthesis comprising i) providing a length of flexible expandable and contractible tubing, ii) coating at least a portion of a contacting surface of the tubing with a parylene material adapted to expand and return to an original configuration, to reduce the coefficient of friction of the contacting surface, and to prevent or inhibit wear or degradation of the flexible expandable and contractible tubing at bend corners or pinch points of crease lines associated with folding or bending of the tubing and iii) sealing the ends of the tubing.

29. The method of claim 28, wherein the tubing is silicone.

30. The method of claim 28, wherein the tubing is polyurethane.

31. The method of claim 28 wherein an inner and outer surface of the tubing is coated.

32. The method of claim 28 further comprising:

masking a portion of the tubing to prevent a masked portion of the tubing from being coated.

33. The method of claim 32 wherein the masking step comprises:

inserting an inner insert into at least a portion of the tubing and wrapping an outer member around at least a portion of the tubing.

34. The method of claim 33 wherein the outer member is shrinkable material which shrinks in diameter when heated.

35. The method of claim 33 wherein the outer member is synthetic latex.

36. The method of claim 28 wherein coating includes placing the tubing into a vapor deposition chamber and introducing a precursor of the parylene material as a vapor into the chamber.

37. The method of claim 28 where sealing the ends includes affixing a front and rear cap to the tubing.