DEVICE FOR REGENERATION OF ARTICULAR CARTILAGE AND OTHER TISSUE

• US 20110112655A1
• Filed: 11/29/2006
• Published: 05/12/2011
• Est. Priority Date: 05/13/1994
• Status: Active Grant

• Current Assignee: Gino Bradica, John H. Brekke, Scott M. Goldman
• Original Assignee: Gino Bradica, John H. Brekke, Scott M. Goldman
• Inventors: Goldman, Scott M., Bradica, Gino, Brekke, John H.
• Granted Patent: US 8,403,996 B2
• Time in Patent Office: Days
• US Class Current: 623/23.72
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 35/16 Blood plasma; Blood serum umbilical cord blood A61K35/51
• CPC Class Codes: A61K 35/28 Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
• CPC Class Codes: A61K 38/15 Depsipeptides; Derivatives thereof
• CPC Class Codes: A61L 27/38 containing added animal cells organs or tissue containing native cells A61L27/36
• CPC Class Codes: A61L 27/3839 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body

Abstract

An implantable device for facilitating the healing of voids in bone, cartilage and soft tissue is disclosed. A preferred embodiment includes a cartilage region comprising a polyelectrolytic complex joined with a subchondral bone region. The cartilage region, of this embodiment, enhances the environment for chondrocytes to grow articular cartilage; while the subchondral bone region enhances the environment for cells which migrate into that region'"'"'s macrostructure and which differentiate into osteoblasts. A hydrophobic barrier exists between the regions, of this embodiment. In one embodiment, the polyelectrolytic complex transforms to hydrogel, following the implant procedure.

Claims

1. An implant device that provides a biologically acceptable and mechanically stable surface structure for regeneration of tissue, said implant device comprising;

a. a first region comprising a regeneration complex comprising at least one resorbable polymer;

b. a second region comprising a regeneration complex comprising collagen; and

c. a zone comprising a hydrophobic barrier.

2. The implant device of claim 1, wherein the second region is arranged to accept the ingress of cells, and having mechanical or physical properties which affect cellular attachment, thereby affecting cell phenotype.

3. The implant device of claim 2, wherein said affecting cellular attachment is caused by interaction between said second region and endocellular fibrils of said cells.

4. The implant device of claim 1, wherein said hydrophobic barrier is arranged at an interface between said first and second regions.

5. The implant device of claim 4 wherein said hydrophobic barrier is arranged as interdigitations between the first and second regions.

6. The implant device of claim 1, wherein said first region is arranged as a subchondral bone region, and the second region is arranged as a cartilage region.

7. The implant device of claim 1, wherein said resorbable polymer regeneration complex comprises a first macrostructure, and said collagen regeneration complex comprises a porous fabric.

8. The implant device of claim 1, wherein at least one of said first region and said second region comprises complex internal architectures.

9. The implant device of claim 4, wherein said hydrophobic barrier comprises a fibrillar membrane arranged to prevent the passage of water-based fluids across the membrane.

10. The implant device of claim 9, wherein said membrane acts as a barrier to the passage of water based fluids at least temporarily.

11. The implant device of claim 9, wherein said hydrophobic membrane is arranged to allow the ingrowth of cells into and through said hydrophobic membrane.

12. The implant device of claim 9, wherein said hydrophobic barrier is arranged to 45 prevent the passage of blood therethrough thereby creating an avascularized region.

13. The implant device of claim 9, wherein said hydrophobic barrier is arranged to prevent the passage of blood across the membrane thereby creating, on one side of the barrier, an avascularized region, and, on the other side of the barrier, a vascularized region.

14. The implant device of claim 7, wherein said porous fabric comprises a second macrostructure comprising a biologically acceptable polymer arranged as a unitary porous body having enclosed pores that are random in size, position and shape, such pores forming interconnecting voids in communication with the exterior of said porous body.

16. The implant device of claim 14, wherein said interconnecting voids of said second macrostructure are arranged to influence forms of regenerated tissue.

17. The implant device of claim 14 herein said second macrostructure is arranged to mimic natural chondrocyte host environment and facilitate regenerative cascades to occur for replication of damaged tissue.

18. The implant device of claim 14, wherein said second macrostructure further comprise a microstructure arranged within the interconnecting voids of the pores of the second macrostructure.

19. The implant device of claim 18, wherein said microstructure is arranged to affect the degree of matrix matching.

20. The implant device of claim 1, wherein said regeneration complex further comprises at least one additive selected from the group consisting of:

composite elements, biologics, pharmaceuticals, or therapies.

21. The implant device of claim 20 wherein said additive is a composite element comprising ceramic.

22. The implant device of claim 21 wherein the ceramic is selected from at least one of the group consisting of calcium phosphate, calcium sulfate and tricalcium phosphate.

23. The implant device of claim 20 wherein the additive is selected from at least one of the group consisting of antiobiotics, anti-coagulants, anti-rejection agents, arteriogenesis agents, cells, chemotherapeutic agents, growth factors, hormones, morphogens or vitamins.

24. The implant device of claim 20, wherein said additive material is added to said second macrostructure.

15. The implant device of 14, with said porous fabric having physical properties arranged to influence interactions between said second macrostructure and endocellular fibrils associated with said second macrostructure.

25. A porous, multi-component device for repair of articular cartilage defects, comprising:

a. a first region comprising a first component in the form of a microstructure presenting a porous intercommunicating network for cellular attachment, and a second component in the form of a fibrous macrostructure supporting the first component and;

b. a second region comprising a third component of porous polymer attached to the first and second components.

26. The device of claim 25, wherein said first component comprises acid soluble collagen.

27. The device of claim 25, wherein said second component comprises insoluble collagen.

28. The device of claim 25, wherein said polymer of said third component comprises polymerized alpha-hydroxy acids.

29. The device of claim 25, wherein said third component further comprises at least one ceramic.

30. The device of claim 25, further comprising a fourth component arranged at an interface between said first and second regions.

31. The device of claim 30, wherein said fourth component comprises a film.

32. The device of claim 31, wherein said film is porous.

33. The device of claim 31, wherein said film is hydrophobic.

34. The device of claim 30, wherein said first region comprises a securement complex for the device, said second region comprises a regeneration complex, and said fourth component comprises interdigitations between the first and second regions.

35. The device of claim 25, wherein said device further comprises at least one additive selected from the group consisting of:

composite elements, biologics, pharmaceuticals, or therapies.

36. The device of claim 35 wherein said additive is a composite element comprising ceramic.

37. The device of claim 36 wherein the ceramic is selected from at least one of the group consisting of calcium phosphate, calcium sulfate and tricalcium phosphate.

38. The device of claim 35 wherein the additive is selected from at least one of the group consisting of antiobiotics, anti-coagulants, anti-rejection agents, arteriogenesis agents, cells, chemotherapeutic agents, growth factors, hormones, morphogens or vitamins.

39. An implantable regeneration complex for the healing of tissue, where such complex provides a network of voids wherein fluids absorbed into the voids allows the complex to take on properties that mimic host tissue in the region of the complex.

40. The implantable regeneration complex of claim 39, wherein said fluids are absorbed from a source comprising the adjacent host tissue.

41. The implantable regeneration complex of claim 39, wherein said properties are selected from at least one of the group consisting of mechanical, chemical or biological.

42. The implantable regeneration complex of claim 39, wherein said absorbed fluids further provide securement of said complex in said host tissue.

43. A porous regeneration complex for the healing of tissue, where such complex provides a network of voids wherein fluids absorbed into the voids alters the physical properties of the complex, such that the complex has properties similar to the host tissue.

44. The porous regeneration complex of claim 43, wherein said properties are selected from at least one of the group consisting of mechanical, chemical or biological.

45. A porous three-component regeneration complex for repair of articular cartilage defects comprising:

a. a first component of rapidly degrading polymer that swells as it imbibes water-based fluids;

b. a second component of polymer associated with the first component that entraps the water-based fluids and said swollen first component; and

c. a third component of polymer attached to said first and second components, said third component being in the form of a matrix matched complex;

wherein the fluids absorbed into the complex allows the complex to take on properties that mimic host tissue in the region of the implanted complex.

46. The regeneration complex of claim 45 wherein the first component is composed of acid soluble collagen.

47. The regeneration complex of claim 45 wherein the second component is composed of insoluble collagen fibers.

48. The regeneration complex of claim 45 wherein the third component is composed of a polymerized alpha-hydroxy acid.

49. The regeneration complex of claim 45 wherein the third component additionally contains a calcium mineral.