Biphasic implant device providing gradient

• US 9,744,123 B2
• Filed: 06/30/2009
• Issued: 08/29/2017
• Est. Priority Date: 06/30/2009
• Status: Active Grant

• Current Assignee: DSM IP Assets BV (DSM-Firmenich AG)
• Original Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Inventors: Castiglione-Dodd, Emme M., Bradioa, Gino, Ebrahiml, Ali, Ringeisen, Timothy A.
• Primary Examiner(s): ZISKA, SUZANNE E
• Application Number:
  US12/495,657
• Publication Number:
  US 20100330181A1
• Time in Patent Office: 2,982 Days
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L

Abstract

Tissue implants prepared for the repair of tissues, especially avascular tissues such as cartilage. One embodiment presents an electric potential capable of receiving and accumulating desirable factors or molecules from surrounding fluid when exposed to dynamic loading. In another embodiment the implant promotes tissue conduction by retarding, restricting and controlling cellular invasion through use of gradients until competent tissue forms. Further embodiments of the tissue implants may be formed into a multi-phasic device that provides deep tissue mechanical stimulus by conduction of mechanical and fluid forces experienced at the surface of the implant.

Claims

1. A method for treating and healing a cartilage defect, comprising applying a cell conductive biodegradable polymer matrix to a cartilage defect, wherein the matrix is in intimate contact with cartilage tissue and wherein the matrix comprises a circular gradient device comprising a core zone having a maximum radial dimension of 2.5 mm, and at least one annular outer zone having a maximum radial width dimension of 2.5 mm,

wherein the at least one outer zone comprises a means for promoting systematic tissue conduction and growth from the cartilage tissue inwardly toward the center of the matrix;

and

wherein said core zone comprises a tissue formation retarding means that retards tissue formation at the interior of the matrix that is not directly connected to the cartilage tissue, said retarding means comprising a property gradient of said cell conductive biodegradable matrix that provides enhanced resistance to degradation at said interior relative to an outer edge of said matrix.

2. The method as defined in claim 1 wherein said circular gradient retards tissue formation at the interior of the matrix by progressively decelerating migration of tissue forming cells.

3. The method as defined in claim 1 wherein the circular gradient forms the cell conductive matrix.

4. The method as defined in claim 1 wherein the circular gradient is independent of the cell conductive matrix.

5. The method as defined in claim 1 wherein said circular gradient retards tissue formation at the interior of the matrix by temporarily preventing tissue forming cells within the center of the matrix from producing an extracellular matrix.

6. The method as defined in claim 1 wherein the circular gradient is in the form of a gradual gradient.

7. The method as defined in claim 1 wherein the circular gradient is in the form of a bull'"'"'s-eye gradient.

8. The method as defined in claim 1 wherein the circular gradient further comprises a concentration gradient.

9. The method as defined in claim 8 wherein the concentration gradient is selected from the group consisting of biologically active agents, additives or combinations thereof.

10. The method as defined in claim 1 wherein the circular gradient is a physical gradient.

11. The method as defined in claim 10 wherein the physical gradient is selected from the group consisting of porosity, density, expansion, swelling, elasticity, hardness, compressibility and combinations thereof.

12. The method as defined in claim 1 wherein the circular gradient is a chemical gradient.

13. The method as defined in claim 12 where the chemical gradient includes molecular weight, cross-linking, hydrophobicity, hydrophilicity, polarity, crystallinity and combinations thereof.

14. The method as defined in claim 1 wherein the circular gradient is a material gradient.

15. The method as defined in claim 1 wherein the matrix also contains at least one biologically active agent.

16. The method as defined in claim 1 wherein the matrix also contains at least one additive.

17. The method as defined in claim 1 wherein the matrix is attached to a porous rigid base.

18. The method as defined in claim 1 wherein the matrix is attached to a rigid base material selected from the groups consisting of metals, polymers, ceramics or combinations thereof.

20. The method of claim 1, wherein said tissue formation retarding means comprises providing said core zone with a higher density than said outer annular zone of said matrix.

21. The method of claim 20, wherein said higher density comprises at least one of smaller pore density and higher molecular weight.

22. The method of claim 1, wherein said tissue formation retarding means comprises providing said core zone of said matrix with a higher percentage of cross-linked polymers than said annular outer zone of said matrix.

29. The method as defined in claim 1, wherein said property gradient comprises at least one of porosity, a materials property and a chemical property of said cell conductive biodegradable polymer matrix.

19. A cell conductive matrix for treating and healing cartilage tissue, said matrix comprising a circular gradient device comprising a core zone having a maximum radial dimension of 2.5 mm, and at least one annular outer zone having a maximum radial width dimension of 2.5 mm, and wherein said gradient comprises a means for promoting systematic tissue conduction originating from tissue with which the matrix is in contact, said gradient further comprising a means for retarding tissue formation within areas of the matrix not yet in contact with ingrowing tissue, said gradient comprising at least one of density, polymer composition and polymer degree of cross-linking.

23. A cell conductive matrix for treating and healing cartilage tissue, said matrix comprising (i) a circular gradient device comprising biodegradable polymer, and (ii) a core region having a maximum radial dimension of 2.5 mm, and (iii) at least one annular outer region, that is closer to a periphery of said matrix than said core region, said at least one annular outer region having a maximum radial width dimension of 2.5 mm, said core region exhibiting enhanced resistance to polymer degradation than said at least one annular outer regions.

24. The cell conductive matrix of claim 23, wherein said gradient comprises at least one of density, polymer composition and polymer degree of cross-linking.

25. The cell conductive matrix of claim 23, wherein said enhanced resistance to polymer degradation results from at least one of higher density, greater degree of polymer cross-linking, and differences in polymer composition relative to said one or more outer regions.

26. The cell-conductive matrix of claim 23, wherein said enhanced resistance to polymer degradation results from providing said core region of said matrix with smaller pores than said one or more outer regions.

27. The cell-conductive matrix of claim 25, wherein said higher density comprises at least one of smaller pore density and higher molecular weight.

28. The cell conductive matrix of claim 23, further comprising at least one biologically active agent.