Foam composite for the repair or regeneration of tissue

• US 7,112,417 B2
• Filed: 08/24/2001
• Issued: 09/26/2006
• 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., Gorky, David V., Bazilio, Clairene A., Melican, Mora C., Chun, Iksoo, Roller, Mark B., Scopelianos, Angelo George, Zimmerman, Mark C.
• Primary Examiner(s): Acquah, Samuel A.
• Application Number:
  US09/938,364
• Publication Number:
  US 20030077311A1
• Time in Patent Office: 1,859 Days
• Field of Search: 428/114, 428/116, 428/118, 428/137, 428/304.4, 428/306.6, 428/308.4, 428/317.9, 428/480, 424/93.1, 424/422, 424/424, 424/425, 424/426, 424/428, 424/443, 424/444, 424/446, 424/447, 424/486, 514/772.3, 514/945, 521/50, 521/134, 521/182, 435/40.5, 435/41, 435/440
• US Class Current: 435/41
• 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 27/3843 : Connective tissue
• CPC Class Codes: A61L 27/3852 : Cartilage, e.g. meniscus
• 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: Y10T 428/24132 : including grain, strips, or filamentary elements in different layers or components parallel
• CPC Class Codes: Y10T 428/24149 : Honeycomb-like
• CPC Class Codes: Y10T 428/24165 : Hexagonally shaped cavities
• CPC Class Codes: Y10T 428/24322 : Composite web or sheet
• CPC Class Codes: Y10T 428/24793 : Comprising discontinuous or differential impregnation or bond
• CPC Class Codes: Y10T 428/249953 : Composite having voids in a component [e.g., porous, cellular, etc.]
• CPC Class Codes: Y10T 428/249955 : Void-containing component partially impregnated with adjacent component
• CPC Class Codes: Y10T 428/249958 : Void-containing component is synthetic resin or natural rubbers
• CPC Class Codes: Y10T 428/249986 : Void-containing component contains also a solid fiber or solid particle
• CPC Class Codes: Y10T 428/268 : Monolayer with structurally defined element
• CPC Class Codes: Y10T 428/31786 : Of polyester [e.g., alkyd, etc.]

Abstract

The present patent describes a biocompatible composite made of a first fibrous layer attached to a three-dimensional inter-connected open cell porous foams that have a gradient in composition and/or microstructure through one or more directions. These composites can be made from blends of absorbable and biocompatible polymers. These biocompatible composites 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 composite comprising a first biocompatible filamentous layer attached to a second biocompatible foam layer wherein the biocompatible foam is selected from the group consisting of gradient foams and channeled foams;

wherein the biocompatible gradient foam has 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 and the channeled foam has a first surface and a second surface with channels therein.

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

3. The method of claim 1 wherein the biocompatible composite 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 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 method of claim 5 wherein the aliphatic polyester is an elastomer.

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

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

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

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

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

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

13. The method of claim 1 wherein the cells are selected from the group consisting of pluripotent cells, stem cells, precursor cells and combinations thereof.

14. The method of claim 1 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 1 wherein the biocompatible composite 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.

16. A method of claim 1 wherein the biocompatible composite is formed from a composition containing in the range of from about 30 weight percent to about 99 weight percent ε

-caprolactone repeating units.

17. The method foam of claim 16 wherein the ε

-caprolactone repeating units are polymerized with a comonomer selected from the group consisting of homopolymers and copolymers of lactide, lactic acid, glycolide, glycolic acid), 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.

18. The method of claim 16 wherein cells are seeded onto the biocompatible composite.

19. The method of claim 16 wherein the biocompatible foam is implanted in an animal and contacted with cells.

20. The method of claim 16 wherein the biocompatible composite is seeded with cells and the biocompatible composite and cells are placed in a cell culturing device and the cells are allowed to multiply on the biocompatible composite.

21. The method of claim 20 wherein the cells are selected from the group consisting of pluripotent cells, stem cells, precursor cells and combinations thereof.

22. The method of claim 20 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.