Reticulated elastomeric matrices, their manufacture and use in implantable devices

• US 7,803,395 B2
• Filed: 05/17/2004
• Issued: 09/28/2010
• Est. Priority Date: 05/15/2003
• Status: Active Grant

• Current Assignee: DSM IP Assets BV (DSM-Firmenich AG)
• Original Assignee: Biomerix Corp.
• Inventors: Friedman, Craig, Klempner, Daniel, Datta, Arindam, Sendijarevic, Aisa
• Primary Examiner(s): BARHAM, BETHANY P
• Application Number:
  US10/848,624
• Publication Number:
  US 20050043816A1
• Time in Patent Office: 2,325 Days
• Field of Search: 424/426, 428/114, 428/116, 428/118, 428/160, 428/423.1
• US Class Current: 424/426
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: C08L 89/06 derived from leather or skin , e.g. gelatin
• CPC Class Codes: Y10T 428/24512 Polyurethane
• CPC Class Codes: Y10T 428/31551 Of polyamidoester [polyurethane, polyisocyanate, polycarbamate, etc.]

Abstract

This invention relates to biodurable, reticulated elastomeric matrices that are resiliently-compressible, their manufacture and uses including uses for implantable devices into or for topical treatment of patients, such as humans and other animals, for therapeutic, nutritional, or other useful purposes.

Claims

1. An implantable device for promoting tissue ingrowth therein comprising:

a reticulated, resiliently-compressible, elastomeric matrix comprising a continuous network of solid structures defining a void space therein, wherein said void space comprises a plurality of interconnected pores forming a continuous network of intercommunicating passageways extending from an interior portion to an exterior surface of said matrix,

wherein said matrix comprises a biocompatible, cross-linked polycarbonate polyurethane-urea formed by a reaction of a mixture comprising;

(i) a polycarbonate polyol, and

(ii) an isocyanate component comprising at least about 5% by weight of said isocyanate component of 2,4′

-diphenylmethane diisocyanate, and

wherein said matrix is substantially free of isocyanurate linkages.

2. The device according to claim 1, wherein said mixture further comprises glycerol.

3. The device according to claim 2, wherein said polycarbonate polyurethane-urea comprises crosslinks by said glycerol.

4. The implantable device of claim 1, wherein an average number of isocyanate groups per molecule in said isocyanate component is greater than 2.

5. The implantable device of claim 4, wherein said average number of isocyanate groups per molecule in said isocyanate component is about 2.33 or greater.

6. The device according to claim 1, wherein said plurality of pores have an average diameter or other largest transverse dimension of at least about 20 μ

m.

7. The device according to claim 6, wherein said plurality of pores have an average diameter or other largest transverse dimension of at least about 50 μ

m.

8. The device according to claim 7, wherein said plurality of pores have an average diameter or other largest transverse dimension of at least about 150 μ

m.

9. The device according to claim 8, wherein said plurality of pores have an average diameter or other largest transverse dimension of at least about 250 μ

m.

10. The device according to claim 1, wherein said isocyanate component comprises from about 5% to about 50% by weight of said isocyanate component of 2,4′

-diphenylmethane diisocyanate.

11. The device according to claim 10, wherein said isocyanate component comprises from about 5% to about 40% by weight of said isocyanate component of 2,4′

-diphenylmethane diisocyanate.

12. The device according to claim 11, wherein said isocyanate component comprises from about 5% to about 35% by weight of said isocyanate component of 2,4′

-diphenylmethane diisocyanate.

13. The device according to claim 1, wherein said isocyanate component further comprises 4,4′

-diphenylmethane diisocyanate.

14. The device according to claim 1, wherein said isocyanate component consists of:

(a) at least about 5% by weight of said isocyanate component of 2,4′

-diphenylmethane diisocyanate, and (b) 4,4′

-diphenylmethane diisocyanate.

15. The device according to claim 1, wherein said matrix is free of isocyanurate linkages.

16. The device according to claim 1, wherein said matrix is substantially free of allophanate and biuret linkages.

17. The device according to claim 16, wherein said matrix is free of allophanate and biuret linkages.

18. The device according to claim 1, wherein said polycarbonate polyol comprises a polycarbonate diol.

19. The device according to claim 1, wherein said void space comprises from about 70% to about 99% of the volume of said matrix.

20. The device according to claim 19 wherein said void space comprises from about 80% to about 98% of the volume of said matrix.

21. The device according to claim 20, wherein said void space comprises from about 90% to about 98% of the volume of said matrix.

22. The device according to claim 1, wherein said isocyanate component has an isocyanate index from about 0.9 to about 1.02.

23. The device according to claim 22, wherein said isocyanate component has an isocyanate index from about 0.9 to about 1.0.

24. The device according to claim 1, wherein said matrix is stable for at least 29 days in a biological environment.

25. The device according to claim 1, wherein said matrix is stable for at least six months in a biological environment.

26. The device according to claim 1, wherein said mixture comprises from about 10 to about 90 parts by weight of said isocyanate component per 100 parts by weight of said polycarbonate polyol.