Biodegradable guide channels comprised of esters of hyaluronic acid for use in tissue repair as surgical aids

• US 5,879,359 A
• Filed: 05/13/1997
• Issued: 03/09/1999
• Est. Priority Date: 08/03/1992
• Status: Expired due to Term

• Current Assignee: Fidia S.P.A.
• Original Assignee: Fidia S.P.A.
• Inventors: Favaro, Giorgio, Callegaro, Lanfranco, Romeo, Aurelio, Dorigatti, Franco
• Primary Examiner(s): Clarke, Robert A.
• Application Number:
  US08/855,285
• Time in Patent Office: 665 Days
• Field of Search: 606/151-156, 623/1, 623/11
• US Class Current: 606/152
• 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: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2430/32 for nerve reconstruction
• CPC Class Codes: A61L 31/047 Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 5/08 Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof

Abstract

The present invention is drawn to medical devices comprising biodegradable guide channels for use in the repair and regeneration of nerve tissue. The guide channels of the present invention comprise interlaced threads imbedded in a matrix, wherein both the matrix and the threads comprise biocompatible and bioabsorbable esters of hyaluronic acid. The matrix of the present invention further optionally comprises biologically or pharmacologically active factors in association with the guide channels.

Claims

1. A medical device for use in the treatment of damaged nerve tissue, said device comprising a tubular, biocompatible and bioabsorbable composite, which comprises:

a matrix comprising a biocompatible, bioabsorbable, water-insoluble ester of hyaluronic acid;

a tubular reinforcement structure comprising interlaced threads comprising a biocompatible, bioabsorbable, water-insoluble ester of hyaluronic acid.

2. The medical device according to claim 1, wherein said ester of hyaluronic acid is a total or partial ester of hyaluronic acid with a pharmacologically inactive alcohol.

3. The medical device according to claim 2, wherein said alcohol is an aliphatic, araliphatic, cycloaliphatic, or heterocyclic alcohol.

4. The medical device according to claim 3, wherein said aliphatic alcohol is a C_1-12 aliphatic alcohol.

5. The medical device according to claim 3, wherein said aliphatic alcohol is benzyl alcohol.

6. The medical device according to claim 1, wherein said ester is a total ester of hyaluronic acid.

7. The medical device according to claim 1, wherein said ester is a partial ester of hyaluronic acid.

8. The medical device according to claim 1, wherein said ester of hyaluronic acid is an ester of hyaluronic acid 75% esterified with benzyl alcohol.

9. The medical device according to claim 1, wherein said interlaced threads have a denier in the range of from about 120 denier to about 600 denier, a tensile strength at break in the range of from about 0.6 gr/denier to about 3.5 gr/denier;

a minimum elongation in the range of from about 3% to about 10%, and a number of threads in the range of from about 8 to about 16.

10. The medical device according to claim 9, wherein said device has a length in the range of from about 5 to about 150 mm, an internal diameter in the range of from about 1 to about 15 mm, a thickness in the range of from about 50 μ

m to about 1,000 μ

m, and a weight in the range of from about 8 mg to about 80 mg, corresponding to 4 to 40 mg/cm.

11. The medical device according to claim 10, wherein said device has a length of 20 mm, an internal diameter of 1.5 to 3 mm, a thickness of 400 μ

m, and a weight of 20 mg, corresponding to 10 mg/cm.

12. The medical device of claim 1 further comprising at least one biologically or pharmacologically active molecule wherein said biologically or pharmacologically active molecule is a molecule that increases and/or stimulates the growth, regeneration, and/or repair of damaged tissues.

13. The medical device according to claim 12, wherein said biologically or pharmacologically active molecule is at least one member selected from the group consisting of nerve growth factor, basic fibroblast growth factor in its acid or basic forms, ciliary neuronotrophic factor, biologically active truncated ciliary neuronotrophic factor, brain-derived neurotrophic factor, neurotrophin-3, neurotrophin-4, a ganglioside, a ganglioside derivative, a ganglioside mixture, a mixture of ganglioside derivatives, and a mixture of any of the foregoing.

14. Use of the medical device according to claim 12 in surgery and microsurgery.

15. The use according to claim 14, wherein said medical device is employed at anatomical sites where conditions of discontinuity and/or loss of substance have occurred.

16. The use according to claim 15, wherein the anatomical site is a damaged peripheral nerve or a damaged tendon.

17. The use according to claim 16, wherein said medical device is used for nerve regeneration or as an adjuvant in neurorrphaphy.

18. The use according to claim 15, wherein said medical device is employed to prevent post-operative adherences and their recurrence.

19. The medical device according to claim 12, the preparation of which includes the co-extrusion of said at least one biologically or pharmacologically active molecule with said threads comprising said tubular reinforcing structure.

20. A process for preparing the medical device according to claim 1, comprising coating said tubular reinforcement structure comprising interlaced threads comprising a biocompatible, bioabsorbable, water-insoluble ester of hyaluronic acid with a solution of a biocompatible, bioabsorbable, water-insoluble ester of hyaluronic acid, using an electropolished steel cylinder holding the rotating tubular reinforcement structure rotating at a minimum of 100 rpm.

21. The process according to claim 20, wherein said coating is performed by spraying said solution.

22. The process of claim 20 wherein said solution further comprises at least one biologically or pharmacologically active molecule.