Fiber-reinforced, porous, biodegradable implant device

• US 6,511,511 B1
• Filed: 10/25/1999
• Issued: 01/28/2003
• Est. Priority Date: 05/30/1997
• Status: Expired due to Term

• Current Assignee: OsteoBiologics Inc. (Smith & Nephew PLC)
• Original Assignee: OsteoBiologics Inc. (Smith & Nephew PLC)
• Inventors: Slivka, Michael, Niederauer, Gabriele G., Kieswetter, Kristine, Leatherbury, Neil C.
• Primary Examiner(s): Isabella, David J
• Application Number:
  US09/426,686
• Time in Patent Office: 1,191 Days
• Field of Search: 623/11.11, 623/16.11, 623/23.34, 623/23.51, 623/23.56, 623/23.58, 623/23.61, 623/23.72, 623/23.75, 623/23.76
• US Class Current: 623/23.75
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2002/30535 Special structural features of bone or joint prostheses not otherwise provided for
• CPC Class Codes: A61F 2250/0058 Additional features; Implant or prostheses properties not otherwise provided for
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: B29C 44/3403 Foaming under special conditions, e.g. in sub-atmospheric pressure, in or on a liquid
• CPC Class Codes: B29C 70/14 oriented
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses

Abstract

A fiber-reinforced, polymeric implant material useful for tissue engineering, and method of making same are provided. The fibers are preferably aligned predominantly parallel to each other, but may also be aligned in a single plane. The implant material comprises a polymeric matrix, preferably a biodegradable matrix, having fibers substantially uniformly distributed therein. In preferred embodiments, porous tissue scaffolds are provided which facilitate regeneration of load-bearing tissues such as articular cartilage and bone. Non-porous fiber-reinforced implant materials are also provided herein useful as permanent implants for load-bearing sites.

Claims

1. A fiber-reinforced biodegradable implant material comprising a biodegradable polymeric matrix having biodegradable fibers of a length no geater than about 1 cm substantially uniformly distributed therein in predominantly parallel orientation, wherein the ratio of the volume of the fibers to the sum of the volume of the fibers and the volume of the polymeric material forming said polymeric matrix is between about 0.05 and about 0.5.

2. An implant made of the material of claim 1.

3. The implant of claim 2 wherein said implant is porous and is a three dimensional structure having an axis with which the fibers are aligned predominantly parallel, wherein the axis is aligned with the primary direction of loading of the implant after its placement in a defect in a load bearing tissue.

4. The implant material of claim 1 also comprising a bioactive agent.

5. The implant material of claim 1 also comprising cells.

6. A multi-phase implant consisting of multiple layers wherein at least one of said layers is made of the implant material of claim 1.

7. The implant material of claim 1 also comprising hollow fibers.

8. The implant material of claim 1 having a pore volume between about 50% and about 80%.

9. The implant material of claim 1 which is porous.

10. The implant material of claim 1 having uniform pore distribution.

11. The implant material of claim 1 which is non-porous.