Implantable putty material

• US 8,497,236 B2
• Filed: 07/25/2008
• Issued: 07/30/2013
• Est. Priority Date: 02/13/1998
• Status: Expired due to Term

• Current Assignee: Zimmer Orthobiologics, Inc. (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Orthobiologics, Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Benedict, James J., Damien, Christopher J.
• Primary Examiner(s): Ariani, Kade
• Application Number:
  US12/180,035
• Publication Number:
  US 20080293617A1
• Time in Patent Office: 1,831 Days
• Field of Search: None
• US Class Current: 514/1.1
• CPC Class Codes: A61L 24/102 Collagen
• CPC Class Codes: A61L 27/24 Collagen

Abstract

The present invention provides compositions for an implantable putty material for delivery of active compounds to a patient. More specifically, the present invention provides a material having a pH of between about 3 and 6 and possessing putty-like physical properties, wherein the composition of the material includes collagen and water. The present invention also provides a method for using the implantable putty material.

Claims

1. An implantable moldable putty material for delivery of an active ingredient to a patient comprising collagen and a first acidic solution having a pH between about 3 and about 6, wherein the collagen has been combined with a sufficient amount of the first acidic solution and formed the moldable putty material, wherein the collagen was previously processed by combining the collagen with a second acidic solution and lyophilizing the combined collagen and second acidic solution;

wherein the first acidic solution includes an acid different from an acid included in the second acidic solution, wherein said putty material has at least one physical property selected from the group consisting of a peak resistance force of at least about 10 g and an extensibility of from about 2 mm to about 25 mm.

2. The implantable putty material of claim 1, wherein said collagen is selected from the group consisting of fibrillar collagen, atelopeptide collagen, telopeptide collagen and tropocollagen.

3. The implantable putty material of claim 1, wherein said collagen is bovine tendon Type I collagen.

4. The implantable putty material of claim 1, wherein said first acidic solution comprises from about 20 mM to about 100 mM of an acid selected from the group consisting of ascorbic acid, citric acid, lactic acid, and malic acid.

5. The implantable putty material of claim 4, wherein said acid is ascorbic acid.

6. The implantable putty material of claim 1, wherein said putty material further comprises an active ingredient.

7. The implantable putty material of claim 6, wherein said active ingredient is selected from the group consisting of osteoinductive materials, growth factors, cartilage inducing factors, angiogenic factors, hormones, antibiotics, and antiviral compounds.

8. The implantable putty material of claim 1, wherein the collagen is present in an amount from about 1% dry weight to about 10% dry weight.

9. The implantable putty material of claim 1, wherein the pH is between about 3.5 and about 5.

10. The implantable putty material of claim 7, wherein the growth factor is selected from the group consisting of basic fibroblast growth factor (bFGF) and transforming growth factor beta (TGF-β

).

11. The implantable putty material of claim 7, wherein the osteoinductive factor is selected from the group consisting of bone growth protein (BGP), bone morphogenetic protein-1 (BMP-1), BMP-2, BMP-3, and osteogenic protein 1 (OP-1).

12. The implantable putty material of claim 11, wherein the osteoinductive factor is natural, recombinant, or synthetic.

13. The implantable putty material of claim 12, wherein the osteoinductive factor is natural and derived from bovine long bones.

14. The implantable putty material of claim 1, further comprising demineralized bone material (DBM).

15. The implantable material of claim 14, wherein the collagen is present in an amount from about 1% dry weight to about 10% dry weight and the DBM is present in an amount from about 92% dry weight to about 96% dry weight.

16. The implantable putty material of claim 1, wherein the second acidic solution is acetic acid.

17. The implantable putty material of claim 6 wherein the active ingredient is an osteoinductive material.

18. The implantable putty material of claim 16, wherein said acetic acid is 50 mM acetic acid.