Porous tissue scaffoldings for the repair or regeneration of tissue

• US 6,534,084 B1
• Filed: 12/19/2000
• Issued: 03/18/2003
• Est. Priority Date: 06/30/1999
• Status: Expired due to Term

• Current Assignee: Endo-Surgery, Inc.
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Vyakarnam, Murty N., Scopelianos, Angelo George, Zimmerman, Mark C., Gorky, David V., Roller, Mark B.
• Primary Examiner(s): Acquah, Samuel A.
• Application Number:
  US09/740,289
• Time in Patent Office: 819 Days
• Field of Search: 424/424, 424/425, 424/426, 424/443, 424/444, 424/446, 424/447, 424/93.1, 514/2, 514/772.3, 514/945
• US Class Current: 424/443
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2002/30004 the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30032 differing in absorbability or resorbability, i.e. in absorption or resorption time
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30766 Scaffolds for cartilage ingrowth and regeneration
• CPC Class Codes: A61F 2002/30784 Plurality of holes
• CPC Class Codes: A61F 2002/3092 having an open-celled or open-pored structure
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0014 having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0023 differing in porosity
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/003 differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/3817 : Cartilage-forming cells, e.g. pre-chondrocytes
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/06 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/146 : Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: Y10S 623/915 : Method or apparatus for preparing biological material

Abstract

The present patent describes a three-dimensional inter-connected open cell porous foams that have a gradient in composition and/or microstructure through one or more directions. These foams can be made from a blend of absorbable and biocompatible polymers that are formed into foams having a compositional gradient transitioning from predominately one polymeric material to predominately a second polymeric material. These gradient foams are particularly well suited to tissue engineering applications and can be designed to mimic tissue transition or interface zones.

Claims

1. A method for the repair or regeneration of tissue comprising contacting cells with a biocompatible gradient foam having a biocompatible gradient foam having a first location and a second location wherein the biocompatible gradient foam has a substantially continuous transition in at least one characteristic selected from the group consisting of composition, stiffness, flexibility, bioabsorption rate and pore architecture from the first location to the second location of said biocompatible gradient foam.

2. The method of claim 1 wherein the biocompatible gradient foam is bioabsorbable.

3. The method of claim 1 wherein the biocompatible gradient foam is made from a bioabsorbable polymer selected from the group consisting of aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyalkylenes oxalates, polyamides, poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups poly(anhydrides), polyphosphazenes, biopolymers and blends thereof.

4. The method foam of claim 3 wherein the bioabsorable polymer is an aliphatic polyester.

5. The method foam of claim 4 wherein the aliphatic polyester is selected from the group consisting of homopolymers and copolymers of lactide, lactic acid, glycolide, glycolic acid), ε

-caprolactone, p-dioxanone (1,4-dioxan-2-one), trimethylene carbonate (1,3-dioxan-2-one), alkyl derivatives of trimethylene carbonate, δ

-valerolactone, β

-butyrolactone, γ

-butyrolactone, ε

-decalactone, hydroxybutyrate, hydroxyvalerate, 1,4-dioxepan-2-one, 1,5,8,12-tetraoxacyclotetradecane-7,14-dione), 1,5-dioxepan-2-one, 6,6-dimethyl-1,4-dioxan-2-one and polymer blends thereof.

6. The biocompatible gradient foam of claim 5 wherein the aliphatic polyester is an elastomer.

7. The method of claim 1 wherein cells are seeded onto the biocompatible gradient foam.

8. The method of claim 5 wherein cells are seeded onto the biocompatible gradient foam.

9. The method of claim 1 wherein the biocompatible gradient foam is implanted in an animal and contacted with cells.

10. The method of claim 5 wherein the biocompatible gradient foam is implanted in an animal and contacted with cells.

11. The method of claim 1 wherein the biocompatible gradient foam is seeded with cells and the biocompatible gradient foam and cells are placed in a cell culturing device and the cells are allowed to multiply on the biocompatible gradient foam.

12. The method of claim 5 wherein the biocompatible gradient foam is seeded with cells and the biocompatible gradient foam and cells are placed in a cell culturing device and the cells are allowed to multiply on the biocompatible gradient foam.

13. The method of claim 5 wherein the cells are selected from the group consisting of pluripotent cells, stem cells, precursor cells and combinations thereof.

14. The method of claim 5 wherein the cells are selected from the group consisting of myocytes, adipocytes, fibromyoblasts, ectodermal cell, muscle cells, osteoblast, chondrocyte, endothelial cells, fibroblast, pancreatic cells, hepatocyte, bile duct cells, bone marrow cells, neural cells, genitourinary cells and combinations thereof.

15. The method of claim 7 wherein the cells are selected from the group consisting of pluripotent cells, stem cells, precursor cells and combinations thereof.

16. The method of claim 7 wherein the cells are selected from the group consisting of myocytes, adipocytes, fibromyoblasts, ectodermal cell, muscle cells, osteoblast, chondrocyte, endothelial cells, fibroblast, pancreatic cells, hepatocyte, bile duct cells, bone marrow cells, neural cells, genitourinary cells and combinations thereof.

17. The method of claim 1 wherein the biocompatible gradient foam contains an agent selected from the group consisting of antiinfectives, hormones, analgesics, anti-inflammatory agents, growth factors, chemotherapeutic agents, anti-rejection agents, prostaglandins, RDG peptides and combinations thereof.

35. The method of claim 11 wherein after the cells are allowed to multiply on the biocompatible foam, the biocompatible foam and the cells are implanted into an animal.

18. A method for the repair or regeneration of tissue comprising contacting cells with a biocompatible foam having a first surface and a second surface with interconnecting pores and channels.

19. The method of claim 18 wherein the biocompatible foam is bioabsorbable.

20. The method of claim 18 wherein the biocompatible foam is made from a bioabsorbable polymer selected from the group consisting of aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyalkylenes oxalates, polyamides, poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups poly(anhydrides), polyphosphazenes, biopolymers and blends thereof.

21. The method of claim 20 wherein the bioabsorable polymer is an aliphatic polyester.

22. The method of claim 21 wherein the aliphatic polyester is selected from the group consisting of homopolymers and copolymers of lactide, lactic acid, glycolide, glycolic acid), ε

-caprolactone, p-dioxanone (1,4-dioxan-2-one), trimethylene carbonate (1,3-dioxan-2-one), alkyl derivatives of trimethylene carbonate, δ

-valerolactone, β

-butyrolactone, γ

-butyrolactone, ε

-decalactone, hydroxybutyrate, hydroxyvalerate, 1,4-dioxepan-2-one, 1,5,8,12-tetraoxacyclotetradecane-7,14-dione), 1,5-dioxepan-2-one, 6,6-dimethyl-1,4-dioxan-2-one and polymer blends thereof.

23. The method of claim 22 wherein the aliphatic polyester is an elastomer.

24. The method of claim 18 wherein cells are seeded onto the biocompatible foam.

25. The method of claim 22 wherein cells are seeded onto the biocompatible foam.

26. The method of claim 18 wherein the biocompatible foam is implanted in an animal and contacted with cells.

27. The method of claim 22 wherein the biocompatible foam is implanted in an animal and contacted with cells.

28. The method of claim 18 wherein the biocompatible foam is seeded with cells and the biocompatible foam and cells are placed in a cell culturing device and the cells are allowed to multiply on the biocompatible foam.

29. The method of claim 22 wherein the biocompatible foam is seeded with cells and the biocompatible foam and cells are placed in a cell culturing device and the cells are allowed to multiply on the biocompatible foam.

30. The method of claim 22 wherein the cells are selected from the group consisting of pluripotent cells, stem cells, precursor cells and combinations thereof.

31. The method of claim 22 wherein the cells are selected from the group consisting of myocytes, adipocytes, fibromyoblasts, ectodermal cell, muscle cells, osteoblast, chondrocyte, endothelial cells, fibroblast, pancreatic cells, hepatocyte, bile duct cells, bone marrow cells, neural cells, genitourinary cells and combinations thereof.

32. The method of claim 24 wherein the cells are selected from the group consisting of pluripotent cells, stem cells, precursor cells and combinations thereof.

33. The method of claim 24 wherein the cells are selected from the group consisting of myocytes, adipocytes, fibromyoblasts, ectodermal cell, muscle cells, osteoblast, chondrocyte, endothelial cells, fibroblast, pancreatic cells, hepatocyte, bile duct cells, bone marrow cells, neural cells, genitourinary cells and combinations thereof.

34. The method of claim 18 wherein the biocompatible foam contains an agent selected from the group consisting of antiinfectives, hormones, analgesics, anti-inflammatory agents, growth factors, chemotherapeutic agents, anti-rejection agents, prostaglandins, RDG peptides and combinations thereof.

36. The method of claim 28 wherein after the cells are allowed to multiply on the biocompatible foam, the biocompatible foam and the cells are implanted into an animal.