Ankle and foot bone growth compositions and methods

• US 9,155,629 B2
• Filed: 11/29/2011
• Issued: 10/13/2015
• Est. Priority Date: 06/13/2002
• Status: Expired due to Fees

• Current Assignee: Neuropro Technologies Inc.
• Original Assignee: Benjamin J. Remington
• Inventors: Remington, Benjamin J., Bearss, David J., Shahi, Kavian
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US13/306,830
• Publication Number:
  US 20120276204A1
• Time in Patent Office: 1,414 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/4405 for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes devices implanted between spinous or transverse processes A61B17/7062
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2310/00359 Bone or bony tissue
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61F 2310/00796 Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: A61K 31/22 of acyclic acids, e.g. pravastatin
• CPC Class Codes: A61K 31/366 having six-membered rings, e.g. delta-lactones
• CPC Class Codes: A61K 31/401 Proline; Derivatives thereof, e.g. captopril
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/434 of enzymes
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders

Abstract

The present invention provides an improved technique for spinal fusion involving the administration of an HMG-CoA reductase inhibitor to a fusion. The HMG-CoA reductase inhibitor is preferably delivered to the site by a carrier. More preferably, the HMG-CoA reductase inhibitor is delivered to the site by a non-compressible delivery vehicle. The invention is suitable for promoting non-anatomic or heterotopic bone growth between any bony surfaces where bone growth is desired but does not naturally occur.

Claims

1. A method for enhancing non-anatomic bone formation of a foot or ankle bone, the method comprising the steps of administering an HMG-CoA reductase inhibitor to the foot or ankle bone.

2. The method of claim 1 wherein the HMG-CoA reductase inhibitor is lovastatin, pravastatin, simvastatin, atorvastatin, dalvastatin, fluindostatin, cerivastatin, mevastatinor velostatin.

3. The method of claim 1 wherein the HMG-CoA reductase inhibitor is administered using a carrier.

4. The method of claim 3 wherein the carrier is a non-compressible carrier.

5. The method of claim 3, wherein the non-compressible carrier is coated with the HMG-CoA reductase inhibitor.

6. The method of claim 3 wherein the carrier is a compressible carrier.

7. The method of claim 6 wherein the compressible carrier is a hydrogel.

8. The method of claim 3 wherein the carrier is an open cell matrix.

9. The method of claim 8 wherein the open cell matrix is formed from collagen fibers.

10. The method of claim 9 wherein the collagen fibers are coated with resorbable hydroxyapatite.

11. The method of claim 10 wherein the hydroxyapatite further comprises calcium.

12. The method of claim 3 wherein the carrier further comprises an antibiotic, an antioxidant, an anti-inflammatory, a growth factor, an immunosuppressant or an analgesic.

13. The method of claim 4 wherein the non-compressible carrier comprises at least one implantation stick for application to the foot or ankle bone.

14. The method of claim 1 wherein the step of administering the HMG-CoA reductase inhibitor includes the step of applying the HMG-CoA reductase inhibitor with a time release drug delivery system.

15. The method of claim 14 wherein the time release drug delivery system comprises a hydrogel.

16. The method of claim 1 wherein the step of administering the HMG-CoA reductase inhibitor includes administering 0.1-1 gram of the HMG-CoA reductase inhibitor to the site per treatment.

17. The method of claim 16 wherein administering is repeated 3-5 times.

18. The method of claim 1 wherein the HMG-CoA reductase inhibitor is administered directly or locally.