Surgical prosthesis having biodegradable and nonbiodegradable regions

• US 20060083767A1
• Filed: 08/12/2005
• Published: 04/20/2006
• Est. Priority Date: 02/27/2003
• Status: Abandoned Application

• Current Assignee: Mast Biosurgery AG, Inc.
• Original Assignee: Mast Biosurgery AG, Inc.
• Inventors: Calhoun, Christopher J., Mullins, Kenton R., Deusch, Kai
• Application Number:
  US11/203,660
• Publication Number:
  US 20060083767A1
• Time in Patent Office: Days
• US Class Current: 424/422
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A prosthesis for repairing a hernia includes an adhesion-resistant biodegradable region and an opposing tissue-ingrowth biodegradable region. When the prosthesis is implanted into the patient, the adhesion-resistant biodegradable region covers a fascial defect of the hernia, and the tissue-ingrowth biodegradable region is located above the adhesion-resistant biodegradable region while being exposed substantially only to the host'"'"'s subcutaneous tissue layer. This orientation allows the tissue-ingrowth biodegradable region to become firmly incorporated with the host'"'"'s body tissue. The adhesion-resistant biodegradable region faces the internal organs and decreases the incidence of adhesions and/or bowel obstruction.

Claims

1. A biodegradable surgical implant for implantation in a host, comprising a substantially planar barrier membrane of resorbable polymer base material having a tissue-ingrowth biodegradable side and an adhesion-resistant biodegradable side, the tissue-ingrowth biodegradable side and the adhesion-resistant biodegradable side differing in both surface appearance and surface function.

2. The biodegradable surgical implant as set forth in claim 1, wherein the tissue-ingrowth biodegradable side and the adhesion-resistant biodegradable side are formed of substantially the same material.

3. The biodegradable surgical implant as set forth in claim 2, wherein one of the tissue-ingrowth biodegradable side and the adhesion-resistant biodegradable side comprises an additive.

4. The biodegradable surgical implant as set forth in claim 3, wherein the additive enhances a rate of biodegradation of the adhesion-resistant biodegradable side relative to that of the tissue-ingrowth biodegradable side.

5. The biodegradable surgical implant as set forth in claim 3, wherein the additive reduces a rate of biodegradation of the tissue-ingrowth biodegradable side relative to that of the adhesion-resistant biodegradable side.

6. The biodegradable surgical implant as set forth in claim 2, wherein one of the tissue-ingrowth biodegradable side and the adhesion-resistant biodegradable side comprises a first composition affecting the side'"'"'s strength or structural integrity relative to a second composition of the other of the tissue-ingrowth biodegradable side and the adhesion-resistant biodegradable side.

7. The biodegradable surgical implant as set forth in claim 6, wherein the first composition comprises a first polymer composition and the second composition comprises a second polymer composition that is different from the first polymer composition.

8. The biodegradable surgical implant as set forth in claim 6, wherein the first composition provides the tissue-ingrowth biodegradable side with a greater strength than a strength that the tissue-ingrowth biodegradable side would have if it were formed of the second composition.

9. The biodegradable surgical implant as set forth in claim 8, wherein the first composition comprises strengthening and reinforcing fibers.

10. The biodegradable surgical implant as set forth in claim 8, wherein the first composition comprises a first polymer composition and the second composition comprises a second polymer composition that is different from the first polymer composition.

11. The biodegradable surgical implant as set forth in claim 2, wherein:

the tissue-ingrowth biodegradable side comprises a first composition;

the adhesion-resistant biodegradable side comprises a second composition; and

the adhesion-resistant biodegradable side comprises a resistance to adhesion that is greater than a resistance to adhesion that would be provided by the adhesion-resistance biodegradable side if formed of the first composition.

12. The biodegradable surgical implant as set forth in claim 11, wherein the first composition comprises a first polymer composition and the second composition comprises a second polymer composition that is different from the first polymer composition.

13. The biodegradable surgical implant as set forth in claim 2, wherein:

the tissue-ingrowth biodegradable side comprises a first composition;

the adhesion-resistant biodegradable side comprises a second composition; and

the adhesion-resistant biodegradable side comprises a resistance to adhesion that is greater than a resistance to adhesion that would be provided by the adhesion-resistance biodegradable side if formed of the first composition.

14. The biodegradable surgical implant as set forth in claim 13, wherein the first composition comprises a first polymer composition and the second composition comprises a second polymer composition that is different from the first polymer composition.

15. The biodegradable surgical implant as set forth in claim 1, wherein:

the biodegradable surgical implant contains a single layer of resorbable polymer base material having a substantially uniform composition; and

a thickness of the single layer of resorbable polymer base material is greater than about 500 microns,

16. The biodegradable surgical implant as set forth in claim 15, wherein the single layer of resorbable polymer base material is non-porous.

17. The biodegradable surgical implant as set forth in claim 15, wherein the single layer of resorbable polymer base material comprises a material selected from the group consisting of a poly-lactide polymer and a copolymer of two or more poly-lactides.

18. The biodegradable surgical implant as set forth in claim 15, wherein the resorbable polymer base material is poly (L-lactide-co-D,L-lactide).

19. The device as set forth in claim 15, wherein the single layer of resorbable polymer base material is not fluid permeable.

20. The biodegradable surgical implant as set forth in claim 1, wherein only one side of the biodegradable surgical implant is impregnated with at least one of an anti-bone agent, a chemotactic substance for influencing cell-migration, an inhibitory substance for influencing cell-migration, a mitogenic growth factor for influencing cell proliferation, a growth factor for influencing cell differentiation, and factors which promote angiogenesis.

21. The biodegradable surgical implant as set forth in claim 1, wherein the biodegradable surgical implant is sealed in a sterile packaging.

22. The biodegradable surgical implant as set forth in claim 1, wherein the biodegradable surgical implant prevents scar formation.

23. The biodegradable surgical implant as set forth in claim 1, wherein the biodegradable surgical implant prevents tissue adhesion.

24. The biodegradable surgical implant as set forth in claim 1, wherein the biodegradable surgical implant comprises a poly-lactide polymer and a copolymer of at least two poly-lactides.

25. The biodegradable surgical implant as set forth in claim 1, wherein the biodegradable surgical implant is impermeable to fluid.

26. The biodegradable surgical implant as set forth in claim 1, wherein the tissue-ingrowth biodegradable side and the adhesion-resistant biodegradable side are formed of the same material.

27. The biodegradable surgical implant as set forth in claim 1, wherein the biodegradable surgical implant contains a single layer of resorbable polymer that forms both the tissue-ingrowth biodegradable side and the adhesion-resistant biodegradable side.

28. The biodegradable surgical implant as set forth in claim 1, wherein:

the biodegradable surgical implant contains a single layer of resorbable polymer base material;

the tissue-ingrowth biodegradable side is integrally formed with the resorbable polymer base material; and

the adhesion-resistant biodegradable side is integrally formed with the resorbable polymer base material.

29. The biodegradable surgical implant as set forth in claim 1, wherein:

the adhesion-resistant biodegradable side comprises a first layer of biodegradable material; and

the tissue-ingrowth biodegradable side comprises a second layer of biodegradable material.

30. The biodegradable surgical implant as set forth in claim 29, wherein the first and second layers are nonporous.

31. The biodegradable surgical implant as set forth in claim 1, wherein the tissue-ingrowth biodegradable side is constructed with one or more of (a) a surface appearance in the form of a surface topography and (2) a surface function in the form of a surface composition, which differs from that of the anti-adhesion biodegradable side and which facilitates one or more of strength, longevity and a substantial fibroblastic reaction in tissue of the host relative to the adhesion-resistant biodegradable side.

32. The biodegradable surgical implant as set forth in claim 31, wherein the tissue-ingrowth biodegradable side is constructed with a surface topography, which differs from that of the anti-adhesion biodegradable side and which facilitates one or more of strength, longevity and a substantial fibroblastic reaction in tissue of the host relative to the adhesion-resistant biodegradable side.

33. The biodegradable surgical implant as set forth in claim 32, wherein the tissue-ingrowth biodegradable side and the adhesion-resistant biodegradable side are formed of substantially the same material.

34. The biodegradable surgical implant as set forth in claim 32, wherein the tissue-ingrowth biodegradable side and the adhesion-resistant biodegradable side are formed of the same material.

35. The biodegradable surgical implant as set forth in claim 32, wherein the biodegradable surgical implant contains a single layer of resorbable polymer that forms both the tissue-ingrowth biodegradable side and the adhesion-resistant biodegradable side.

36. The biodegradable surgical implant as set forth in claim 32, wherein:

the biodegradable surgical implant contains a single layer of resorbable polymer base material;

the tissue-ingrowth biodegradable side is integrally formed with the resorbable polymer base material; and

the adhesion-resistant biodegradable side is integrally formed with the resorbable polymer base material.

37. The biodegradable surgical implant as set forth in claim 32, wherein the tissue-ingrowth biodegradable side is formed to have an open, non-smooth and featured surface.

38. The biodegradable surgical implant as set forth in claim 37, wherein the tissue-ingrowth biodegradable side is formed to have one or more of alveoli and pores.

39. The biodegradable surgical implant as set forth in claim 38, wherein the tissue-ingrowth biodegradable side is formed to have one or more of alveoli and pores distributed irregularly on the tissue-ingrowth biodegradable side.

40. The biodegradable surgical implant as set forth in claim 38, wherein the tissue-ingrowth biodegradable side is formed to have pores, which are distributed in an irregular fashion and which are visible to the naked eye.

41. The biodegradable surgical implant as set forth in claim 37, wherein the tissue-ingrowth biodegradable side is formed to have one or more of a cracked, broken or flaked surface, which causes tissue turbulence and inflammation between tissues of the host and the tissue-ingrowth biodegradable side.

42. The biodegradable surgical implant as set forth in claim 1, wherein the adhesion-resistant biodegradable side is constructed with one or more of (a) a surface topography and (2) a surface composition, which differs from that of the tissue-ingrowth biodegradable side and which facilitates, relative to the tissue-ingrowth biodegradable side, an anti-adhesive effect between the biodegradable surgical implant and tissue of the host.

43. The biodegradable surgical implant as set forth in claim 42, wherein the adhesion-resistant biodegradable side is constructed with a surface topography, which differs from that of the tissue-ingrowth biodegradable side and which facilitates, relative to the tissue-ingrowth biodegradable side, an anti-adhesive effect between the biodegradable surgical implant and tissue of the host.

44. The biodegradable surgical implant as set forth in claim 42, wherein the adhesion-resistant biodegradable side comprises a substantially smooth surface.

45. The biodegradable surgical implant as set forth in claim 42, wherein:

the adhesion-resistant biodegradable side comprises a first layer of biodegradable material; and

the tissue-ingrowth biodegradable side comprises a second layer of biodegradable material.

46. The biodegradable surgical implant as set forth in claim 42, wherein the adhesion-resistant biodegradable side comprises a first layer of nonporous biodegradable material;

and

the tissue-ingrowth biodegradable side comprises a second layer of nonporous biodegradable material.