Biopolymer foams for use in tissue repair and reconstruction

• US 6,153,292 A
• Filed: 03/30/1999
• Issued: 11/28/2000
• Est. Priority Date: 11/22/1994
• Status: Expired due to Fees

• Current Assignee: TEI Biosciences, Inc. (Integra LifeSciences Holdings Corporation)
• Original Assignee: Tissue Engineering, Inc. (Integra LifeSciences Holdings Corporation)
• Inventors: Bell, Eugene, Fofonoff, Timothy W., Sioussat, Tracy M.
• Primary Examiner(s): COPENHEAVER, BLAINE R
• Application Number:
  US09/282,088
• Time in Patent Office: 609 Days
• Field of Search: 442/370, 442/30, 442/221, 428/318.4, 428/323, 428/305.5, 428/317.9, 428/315.7, 428/321.7, 623/1, 623/13, 623/15
• US Class Current: 428/305.5
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 2430/06 for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 2430/10 for reconstruction of tendons or ligaments
• CPC Class Codes: A61L 2430/12 for dental implants or prostheses
• CPC Class Codes: A61L 2430/28 for liver reconstruction
• CPC Class Codes: A61L 27/12 Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/3817 Cartilage-forming cells, e.g. pre-chondrocytes
• CPC Class Codes: A61L 27/3826 Muscle cells, e.g. smooth muscle cells
• CPC Class Codes: A61L 27/46 with phosphorus-containing inorganic fillers
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/60 Materials for use in artificial skin
• CPC Class Codes: C08L 89/06 derived from leather or skin , e.g. gelatin
• CPC Class Codes: C12N 2533/54 Collagen; Gelatin
• CPC Class Codes: C12N 5/0068 : General culture methods using substrates for specific animal cell type C12N5/06
• CPC Class Codes: Y10S 623/924 : Material characteristic
• CPC Class Codes: Y10T 428/24992 : Density or compression of components
• CPC Class Codes: Y10T 428/249954 : With chemically effective material or specified gas other than air, N, or carbon dioxide in void-containing component
• CPC Class Codes: Y10T 428/249979 : Specified thickness of void-containing component [absolute or relative] or numerical cell dimension
• CPC Class Codes: Y10T 428/249981 : Plural void-containing components
• CPC Class Codes: Y10T 428/249986 : Void-containing component contains also a solid fiber or solid particle
• CPC Class Codes: Y10T 428/249999 : Differentially filled foam, filled plural layers, or filled layer with coat of filling material
• CPC Class Codes: Y10T 428/25 : Web or sheet containing structurally defined element or component and including a second component containing structurally defined particles
• CPC Class Codes: Y10T 442/15 : Including a foam layer
• CPC Class Codes: Y10T 442/3325 : Including a foamed layer or component
• CPC Class Codes: Y10T 442/647 : Including a foamed layer or component

Abstract

Single and double density biopolymer foams, composite biopolymer foams including both single and double density foams, and methods of preparing these foams and composite foams are described. Also described are biocompatible constructs which include single or double density biopolymer foams and extracellular matrix particulates and methods of preparing these constructs. The foams, composite foams, and biocompatible constructs of the invention can be used in tissue repair and reconstruction.

Claims

1. A bioabsorbable composite biopolymer foam comprising a single density biopolymer foam comprising a network of communicating microcompartments having biopolymer molecules and/or biopolymer filaments interspersed within the walls of the microcompartments, wherein the microcompartments have volume dimensions of x, y, and z, wherein x=length, y=width, and z=height, that are substantially equal, and range from about 1 μ

m to about 300 μ

m, and have an average wall thickness of less than about 10 μ

m and a second bioabsorbable biopolymer which is within the single density biopolymer foam.

2. The composite biopolymer foam of claim 1 wherein the biopolymer of the biopolymer foam or the second biopolymer is selected from the group consisting of collagen, alginic acid, polyvinyl alcohol, chondroitin sulfate, laminin, elastin, fibronectin, and fibrinogen.

3. The composite biopolymer foam of claim 2 wherein the biopolymer foam or the second biopolymer is collagen.

4. The composite biopolymer foam of claim 3 wherein the collagen is fetal porcine collagen.

5. The composite biopolymer foam of claim 3 wherein the collagen is polymerized.

6. The composite biopolymer foam of claim 3 wherein the collagen is crosslinked.

7. The composite biopolymer foam of claim 6 wherein the collagen is crosslinked by priming with lysyl oxidase.

8. The composite biopolymer foam of claim 1 further comprising extracellular matrix particulates.

9. The composite biopolymer foam of claim 1 wherein the biopolymer foam and/or the second biopolymer further comprises cells.

10. The composite biopolymer foam of claim 1 wherein the second biopolymer comprises a fiber or fibers.

11. A skin dressing comprising the composite biopolymer foam of claim 10.

12. A skin dressing of claim 11 further comprising extracellular matrix particulates.

13. The skin prosthesis of claim 10 wherein the biopolymer foam is conditioned with human dermal fibroblasts and human keratinocytes such that a stratum corneum is formed.

14. A vascular prosthesis comprising the composite biopolymer foam of claim 10, wherein the composite biopolymer foam is in the form of a tube having an internal surface, an external surface, and a luminal surface.

15. The vascular prosthesis of claim 14, wherein the tube is seeded internally with smooth muscle cells, externally with adventitial fibroblasts, and on its luminal surface with endothelial cells.

16. A periodontal prosthesis comprising the composite biopolymer foam of claim 10, wherein the biopolymer foam is seeded with periodontal ligament cells.

17. The periodontal prosthesis of claim 16, further comprising extracellular matrix particulates.

18. The composite biopolymer foam of claim 1 wherein the second biopolymer comprises a braid.

19. A ligament prosthesis comprising the composite biopolymer foam of claim 10 or 18.

20. The composite biopolymer foam of claim 1 wherein the second biopolymer comprises a fabric.

21. The composite biopolymer foam of claim 20 wherein the fabric is a nonwoven fabric.

22. The composite biopolymer foam of claim 1 wherein the second biopolymer comprises a mesh.