Load bearing biocompatible device

• US 7,910,124 B2
• Filed: 02/07/2005
• Issued: 03/22/2011
• Est. Priority Date: 02/06/2004
• Status: Active Grant

• Current Assignee: Georgia Tech Research Corporation (University System of Georgia)
• Original Assignee: Georgia Tech Research Corporation (University System of Georgia)
• Inventors: Schwartz, Zvi, Kennedy, Stephen J., Boyan, Barbara D., Ku, David N., Guldberg, Robert E.
• Primary Examiner(s): Azpuru; Carlos A
• Application Number:
  US11/053,409
• Publication Number:
  US 20050273178A1
• Time in Patent Office: 2,234 Days
• Field of Search: None
• US Class Current: 424/424
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• 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 2002/30784 Plurality of holes
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0023 differing in porosity
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis

Abstract

Implantable biomaterials, particularly hydrogel substrates with porous surfaces, and methods for enhancing the compatibility of biomaterials with living tissue, and for causing physical attachment between biomaterials and living tissues are provided. Also provided are implants suitable for load-bearing surfaces in hard tissue repair, replacement, or augmentation, and to methods of their use. One embodiment of the invention relates to an implantable spinal disc prosthesis.

Claims

1. A hydrogel having a surface, comprising:

a microarchitecture that determines cell response, said microarchitecture comprising superficial pores located on or near the surface of the hydrogel;

wherein said superficial pores do not extend throughout an entire depth of said hydrogel;

wherein said superficial pores enhance osteoblast differentiation and permit proliferation of osteoblasts;

wherein said hydrogel is load-bearing; and

wherein said hydrogel comprises at least one bioactive agent.

2. The hydrogel of claim 1, wherein the hydrogel is configured for implantation into at least one of a knee, shoulder or spine.

3. The hydrogel of claim 1, wherein the pores have an average cross-section of between about 1 to 100 micrometers.

4. The hydrogel of claim 1, wherein the pores have an average cross-section of between about 10 to 30 micrometers.

5. The hydrogel of claim 1, wherein the pores are within about 1 millimeter of the surface of the hydrogel.

6. The hydrogel of claim 1, wherein the pores are within about 200 micrometers of the surface of the hydrogel.

7. The hydrogel of claim 1, wherein the hydrogel comprises polyvinyl alcohol.

8. The hydrogel of claim 1, wherein the hydrogel has a moisture content of at least 5% w/w of the overall hydrogel.

9. The hydrogel of claim 1, wherein the hydrogel has a moisture content of at least 30% w/w of the overall hydrogel.

10. The hydrogel of claim 1, wherein said at least one bioactive factor-stimulates cellular growth or differentiation.

11. The hydrogel of claim 1, wherein the hydrogel comprises a chemically-modified or polar surface to promote cellular adhesion.

12. A hydrogel comprising:

a hydrogel surface having a plurality of superficial pores thereon;

wherein said superficial pores are located at or near said hydrogel surface;

wherein said superficial pores do not extend throughout said hydrogel;

wherein the hydrogel is configured for implantation into a joint;

wherein said hydrogel comprises at least one bioactive agent;

wherein the superficial pores have an average cross-section of between about 1 and 100 micrometers; and

wherein the pores are within about 1 millimeter of the hydrogel surface.

13. The hydrogel of claim 12, wherein the hydrogel comprises a plurality of regions having variable elasticity.

14. The hydrogel of claim 12, wherein the hydrogel comprises a surface region having a lower modulus of elasticity than an interior region of said hydrogel.