Composite membranes for the guided regeneration of tissues

• US 5,622,707 A
• Filed: 12/18/1992
• Issued: 04/22/1997
• Est. Priority Date: 12/18/1991
• Status: Expired due to Term

• Current Assignee: Murst Italian Ministry For Universities and Scientific and Technological Research
• Original Assignee: Murst Italian Ministry For Universities and Scientific and Technological Research
• Inventors: Callegaro, Lanfranco, Dorigatti, Franco, Romeo, Aurelio
• Primary Examiner(s): Webman, Edward J.
• Application Number:
  US07/992,697
• Time in Patent Office: 1,586 Days
• Field of Search: 424/486, 424/488, 424/444, 428/113, 606/228, 606/230
• US Class Current: 424/402
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61F 2/105 Skin implants, e.g. artificial skin
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 31/041 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 31/042 Polysaccharides
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 5/00 Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
• CPC Class Codes: C08L 5/04 Alginic acid; Derivatives thereof
• CPC Class Codes: C08L 5/08 Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof
• CPC Class Codes: Y10T 428/24124 Fibers
• CPC Class Codes: Y10T 442/172 Coated or impregnated

Abstract

Biomaterials are disclosed comprised of biodegradable, biocompatible, and bioabsorbable composite membranes for use in surgery for the guided regeneration of tissues. The composite membranes are comprised of threads embedded in a matrix, wherein both the matrix and the threads can be comprised of esters of hyaluronic acid, used singly or in combination, or esters of hyaluronic acid in combination with esters of alginic acid or other polymers.

Claims

1. A composite membrane, comprising a reinforcing mesh embedded in and chemically linked to a polymeric matrix, wherein said mesh comprises fibers selected from the group consisting of fibers of a hyaluronic acid ester, and a combination of fibers of a hyaluronic acid ester and an alginic acid ester, and said polymeric matrix comprises a material selected from the group consisting of a hyaluronic acid ester, alginic acid, an alginic acid ester, and a gelled polysaccharide.

2. The composite membrane of claim 1, wherein the alcohol of said hyaluronic acid ester or said alginic acid ester is a pharmacologically inactive alcohol.

3. The composite membrane of claim 2, wherein said alcohol is an aliphatic, araliphatic, cycloaliphatic, or heterocyclic alcohol.

4. The composite membrane of claim 1, wherein said gelled polysaccharide is a member selected from the group consisting of chitin, an alginate, chitosan, gellan, a synthetic derivative of any one of the foregoing, a semisynthetic derivative of any one of the foregoing, and mixtures thereof.

5. The composite membrane of claim 1, wherein the alcohol of said hyaluronic acid ester or said alginic acid ester is a pharmacologically active alcohol.

6. The composite membrane of claim 1, wherein said reinforcing mesh comprises a multifilament mesh comprising multiple threads of about 70 strands, wherein the thread is about 150 denier, and wherein the multifilaments are twisted about 90 times per meter, and which is worked into a knitted fabric with a gauge of about 12.

7. The composite membrane of claim 1, wherein said reinforcing mesh comprises fibers of a single hyaluronic acid ester or fibers of a mixture of different hyaluronic acid esters.

8. The composite membrane of claim 1, wherein said reinforcing mesh comprises fibers of a single alginic acid ester or fibers of a mixture of different alginic acid esters.

9. The composite membrane of claim 1, wherein said reinforcing mesh comprises fibers of a mixture of a hyaluronic acid ester and an alginic acid ester.

10. The composite membrane of claim 1, wherein said reinforcing mesh comprises fibers of a mixture of hyaluronic acid esters and alginic acid esters.

11. The composite membrane of claim 1, wherein said reinforcing mesh comprises fibers of a mixture of hyaluronic acid esters, alginic acid esters, and a gelled polysaccharide selected from the group consisting of chitin, an alginate, chitosan, gellan, a synthetic derivative thereof, a semisynthetic derivative thereof, and mixtures thereof.

12. The composite membrane of claim 1, wherein both said fibers of said reinforcing mesh and said matrix comprise hyaluronic acid or a derivative thereof.

13. The composite membrane of claim 12, wherein said derivative is a hyaluronic acid ester.

14. The composite membrane of claim 13, wherein said reinforcing mesh comprises fibers of the ethyl ester of hyaluronic acid, and said matrix comprises the benzyl ester of hyaluronic acid.

15. The composite membrane of claim 13, wherein said reinforcing mesh comprises fibers of the benzyl ester of hyaluronic acid, and said matrix comprises a partial benzyl ester of hyaluronic acid.

16. The composite membrane of claim 15, wherein said partial benzyl ester of hyaluronic acid is a 75% benzyl ester of hyaluronic acid.

17. The composite membrane of claim 13, wherein said reinforcing mesh comprises fibers of the ethyl ester of hyaluronic acid, and said matrix comprises a partial benzyl ester of hyaluronic acid.

18. The composite membrane of claim 17, wherein said partial benzyl ester of hyaluronic acid is a 75% benzyl ester of hyaluronic acid.

19. The composite membrane of claim 1, wherein said mesh comprises a mixture of fibers of hyaluronic acid benzyl ester and fibers of alginic acid benzyl ester, and said matrix comprises a partial benzyl ester of hyaluronic acid.

20. The composite membrane of claim 19, wherein said fibers are present in equal amounts, and wherein said partial benzyl ester of hyaluronic acid is a 75% benzyl ester of hyaluronic acid.

21. The composite membrane of claim 1, having a basis weight between about 8 g/cm² and about 50 g/cm², a gauge of about 0.08 mm to about 0.5 mm, a minimum tensile strength at break when dry between about 100 Kg/cm² and about 500 Kg/cm², elongation when dry between about 3% and about 12%, a minimum tensile strength at break when wet between about 30 Kg/cm² and about 450 Kg/cm² and elongation when wet between about 20% and about 60%, and a tear strength when dry between about 40 Kg/cm² and about 200 Kg/cm² and tear strength when wet between about 20 Kg/cm² and about 160 Kg/cm².

22. The composite membrane of claim 1, having a basis weight of about 14 mg/cm², a gauge from about 0.25 mm, a minimum tensile strength at break when dry from about 400 Kg/cm², elongation when dry, about 7%, a minimum tensile strength at break when wet from about 50 Kg/cm² and elongation when wet, about 55%, with a tear strength when dry, about 90 Kg/cm² and tear strength when wet, about 50.

23. The composite membrane of claim 1, having a basis weight of about 10 mg/cm², a gauge from about 0.15 mm, a minimum tensile strength at break when dry from about 300 Kg/cm², elongation when dry, about 4%, a minimum tensile strength at break when wet from about 40 Kg/cm² and elongation when wet, about 45%, with a tear strength when dry, about 120 Kg/cm² and tear strength when wet, about 60.

24. The composite membrane of claim 1, wherein said reinforcing mesh comprises a multifilament mesh comprising multiple threads of between about 30 and about 120 strands between about 18 microns and about 35 microns in diameter, wherein the thread is between about 150 and about 400 denier, wherein the multifilaments are twisted between about 90 and about 200 times per meter, and which is worked into a knitted fabric with a gauge between about 10 and about 16.

25. The composite membrane of claim 1, wherein said reinforcing mesh comprises a multifilament mesh comprising multiple threads of at least 100 strands, wherein the thread is about 237 denier, and wherein the multifilaments are twisted about 135 times per meter, and which is worked into a knitted fabric with a gauge of about 14.

26. A composite membrane, comprising a reinforcing mesh embedded in and chemically linked to a polymeric matrix, wherein said reinforcing mesh comprises fibers of a partial hyaluronic acid ester, and said polymeric matrix comprises a partial hyaluronic acid ester.

27. The composite membrane of claim 26, wherein said reinforcing mesh comprises a partial benzyl ester of hyaluronic acid, and said polymeric matrix comprises a partial benzyl ester of hyaluronic acid.