Medical Devices Based On Poly(Vinyl Alcohol)

• US 20090171264A1
• Filed: 12/18/2008
• Published: 07/02/2009
• Est. Priority Date: 12/21/2007
• Status: Abandoned Application

• Current Assignee: Depuy Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Products Incorporated (Johnson & Johnson)
• Inventors: King, Richard, Hanes, Mark
• Application Number:
  US12/338,324
• Publication Number:
  US 20090171264A1
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61F 2002/30766 Scaffolds for cartilage ingrowth and regeneration
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61N 1/0448 Drug reservoir
• CPC Class Codes: B29C 2035/085 using gamma-ray
• CPC Class Codes: C08K 5/053 Polyhydroxylic alcohols
• CPC Class Codes: C08L 29/04 Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids

Abstract

Provided are orthopedic implants and scaffolds comprising poly(vinyl alcohol) which has a degree of hydrolysis of at least 90% and a weight average molecular weight of at least 50,000. Also provided are methods for making same.

Claims

1. A medical device comprising:

poly(vinyl alcohol), wherein said poly(vinyl alcohol) has a degree of hydrolysis of at least 90% and a weight average molecular weight of at least 50,000 Daltons, and

a therapeutic composition;

said device having 10-50 weight percent content of at least one of water and plasticizer.

2. The medical device of claim 1, wherein the poly(vinyl alcohol) is cross-linked.

3. The medical device of claim 1, wherein the poly(vinyl alcohol) is at least 98% hydrolysed.

4. The medical device of claim 1, further comprising a plasticizer.

5. The medical device of claim 4, wherein the plasticizer comprises glycerol.

6. The medical device of claim 1, further comprising water.

7. The medical device of claim 1, wherein said medical device is an orthopedic implant.

8. The medical device of claim 7 having an articulating surface that comprises said poly(vinyl alcohol).

9. The medical device of claim 7, further comprising a therapeutic composition.

10. The medical device of claim 7, further comprising water.

11. The medical device of claim 1, wherein said medical device is a scaffold for soft tissue repair and regeneration

12. The scaffold of claim 11, further comprising a therapeutic composition.

13. A method of forming an article comprising:

contacting poly(vinyl alcohol) having a weight average molecular weight of at least 50,000 Daltons and a degree of hydrolysis of at least 90% with an amount of one or more plasticizers that constitutes 10-50% of the weight percent of the poly(vinyl alcohol), thereby forming a plasticized material; and

molding the plasticized material to form a consolidated article.

18. The method of claim 13, wherein the poly(vinyl alcohol) is at least 98% hydrolysed.

19. The method of claim 13, further comprising altering the hardness of said article by

(a) subjecting said article to a temperature below 0°

C. and then subjecting said article to a pressure below atmospheric pressure;

or

(b) cross-linking the poly(vinyl alcohol) to form cross-linked PVA and subjecting said article comprising cross-linked PVA to an aqueous solution at a temperature above 70°

C.

24. The method of claim 13, wherein the cross-linked article is an orthopedic implant.

25. The method of claim 13, wherein the cross-linked article is a scaffold for soft tissue regeneration.

14. The method of clam 13, wherein the plasticizer comprises glycerol.

15. The method of claim 14, further comprising cross-linking the poly(vinyl alcohol) to form a cross-linked article.

16. The method of claim 15, wherein the cross-linking is accomplished by exposing the poly(vinyl alcohol) to high-energy ionization radiation.

17. The method of claim 15, further comprising contacting the cross-linked article with water for a time and under conditions that are effective to remove at least a portion of the glycerol.

20. The method of claim 14, wherein the compression moldable material further comprises sodium chloride.

21. The method of claim 20, further comprising contacting the cross-linked article with water for a time and under conditions that are effective to remove at least a portion of the glycerol and sodium chloride.

22. The method of claim 21, wherein at least 90% of the glycerol and at least 90% of the sodium chloride are removed by contacting the cross-linked article with water.

23. The method of claim 14, wherein the poly(vinyl alcohol) is in granular form when contacted with the glycerol.

26. An iontophoresis device comprising:

a chamber comprising poly(vinyl alcohol), wherein said poly(vinyl alcohol) has a degree of hydrolysis of at least 90% and a weight average molecular weight of at least 50,000 Daltons;

a therapeutic composition within said chamber; and

an electrical power source in communication with said chamber.

27. The iontophoresis device of claim 26, wherein the poly(vinly alcohol) is cross-linked.

28. The iontophoresis device of claim 26, wherein the poly(vinyl alcohol) is at least 98% hydrolysed.

29. The iontophoresis device of claim 26, wherein said therapeutic composition is delivered transdermally.

30. The iontophoresis device of claim 26, wherein said therapeutic agent has a positive or negative charge