SURGICAL PROSTHESIS HAVING BIODEGRADABLE AND NONBIODEGRADABLE REGIONS

• US 20080091277A1
• Filed: 12/05/2007
• Published: 04/17/2008
• Est. Priority Date: 08/13/2004
• Status: Abandoned Application

• Current Assignee: MAST Biosurgery AG
• Original Assignee: MAST Biosurgery AG
• Inventors: Deusch, Kai, Mullins, Kenton, Calhoun, Christopher
• Application Number:
  US11/951,069
• Publication Number:
  US 20080091277A1
• Time in Patent Office: Days
• US Class Current: 623/23.74
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2090/0816 for preventing adhesion
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues
• CPC Class Codes: A61F 2002/009 for hindering or preventing attachment of biological tissue
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts

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

2. The surgical implant as set forth in claim 1, wherein the non-biodegradable component comprises a composition of the tissue-ingrowth region affecting one or more of a strength and a structural integrity of the tissue-ingrowth region.

3. The surgical implant as set forth in claim 1, wherein the non-biodegradable component forms the tissue-ingrowth region.

4. The surgical implant as set forth in claim 1, wherein the non-biodegradable component comprises a composition of the tissue-ingrowth region affecting one or more of a strength and a structural integrity of the tissue-ingrowth region.

5. The surgical implant as set forth in claim 4, wherein the composition comprises strengthening and reinforcing fibers.

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

the tissue-ingrowth region comprises a first composition;

the adhesion-resistant region comprises a second composition; and

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

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

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

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

8. The surgical implant as set forth in claim 1, wherein the surgical implant comprises a material selected from the group consisting of a poly-lactide polymer and a copolymer of two or more poly-lactides.

9. The device as set forth in claim 1, wherein the adhesion-resistant region is not fluid permeable.

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

11. The surgical implant as set forth in claim 1, wherein the tissue-ingrowth region 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 region and which facilitates one or more of strength, longevity and a substantial fibroblastic reaction in tissue of the host relative to the adhesion-resistant region.

12. The surgical implant as set forth in claim 1, wherein the tissue-ingrowth region is formed to have an open, non-smooth and featured surface.

13. The surgical implant as set forth in claim 12, wherein the tissue-ingrowth region is formed to have one or more of alveoli and pores.

14. The surgical implant as set forth in claim 13, wherein the tissue-ingrowth region is formed to have one or more of alveoli and pores distributed irregularly on the tissue-ingrowth region.

15. The surgical implant as set forth in claim 13, wherein the tissue-ingrowth region is formed to have pores, which are visible to the naked eye.

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

the tissue-ingrowth region forms a first side of the surgical implant; and

the adhesion-resistant region forms a second side of the surgical implant.

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

the tissue-ingrowth region comprises a first layer of the surgical implant; and

the adhesion-resistant region comprises a second layer of the surgical implant.

18. The surgical implant as set forth in claim 1, wherein the tissue-ingrowth region and the adhesion-resistant region are disposed adjacent to one another on one side of the surgical implant.

19. The surgical implant as set forth in claim 18, wherein the non-biodegradable component forms the tissue-ingrowth region.

20. The surgical implant as set forth in claim 1, wherein the non-biodegradable component is disposed on a surface of the tissue-ingrowth region.

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

the composition comprises strengthening and reinforcing fibers; and

the fibers comprise non-biodegradable polymers.

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

the composition comprises fibers; and

the fibers comprise one or more of (a) a thermoplastic resin, (b) polymethacrylate, (c) polymethylmethacrylate (PMMA), and (d) combinations thereof.

23. The surgical implant as set forth in claim 1, wherein the tissue-ingrowth region and the adhesion-resistant region are arranged on one layer.

24. The surgical implant as set forth in claim 1, wherein heat bonding is used to join the tissue-ingrowth biodegradable region and the adhesion-resistant region.

25. The surgical implant as set forth in claim 1, wherein the tissue-ingrowth region comprises a polymer or copolymer derived from one or more cyclic esters.

26. The surgical implant as set forth in claim 1, wherein the tissue-ingrowth region comprises a non-biodegradable polymer.

27. The surgical implant as set forth in claim 1, wherein

the tissue-ingrowth region comprises one or more of

(a) a thermoplastic resin, (b) polymethacrylate,

(c) polymethylmethacrylate (PMMA), and (d) a combination thereof.