Claims for Patent: 7,923,432

Summary for Patent: 7,923,432

Title:	Implant depots to deliver growth factors to treat avascular necrosis
Abstract:	The present invention relates to the design and composition of a depot implant for optimal delivery of growth factors to treat bone avascular necrosis, in that such depot implant is constructed to be in a cylinder (rod) or sphere shape and have a natural or synthetic polymer scaffold with or without impregnated calcium phosphate particles. The density of the depot is higher than a typical BMP sponge carrier to facilitate its implantation and slower release of the growth factor. The scaffold is such that it has adequate porosity and pore size to facilitate growth factor seeding and diffusion throughout the whole of the bone structure resulting in increased new blood vessel growth and density in the avascular necrotic bone. In addition, the shape of the depot implant allows for delivery through a cannula or large bore needle.
Inventor(s):	McKay; William F. (Memphis, TN)
Assignee:	Warsaw Orthopedic, Inc. (N/A)
Application Number:	11/595,087
Patent Claims:	1. A method for treating avascular necrosis of bone comprising: a) identifying a target site with an avascular necrosis area of bone; and b) administering to the site a therapeutic agent comprising an angiogenic substance comprising a growth factor, wherein the therapeutic agent is administered in a depot implant comprising a dense scaffold having a porosity of 2% to 40% and containing collagen and impregnated with calcium phosphate particles, the dense scaffold disposed throughout the entire depot implant and having adequate pore size and porosity to facilitate seeding and diffusion of the growth factor to slow its release from the depot implant to host bone, wherein the growth factor is in liquid form and completely fills a central hollow chamber of the depot implant. 2. The method according to claim 1, wherein the therapeutic agent further comprises an anti-inflammatory agent. 3. The method according to claim 2, wherein the anti-inflammatory agent comprises anti-cytokine agents selected from the group consisting of TNF-.alpha. inhibitors, IL-1 inhibitors, IL-6 inhibitors, IL-8 inhibitors, IL-12 inhibitors, IL-15 inhibitors, IL-10, NFkappaB inhibitors, and IFN-.gamma.. 4. The method according to claim 1, wherein the therapeutic agent further comprises an antibiotic agent. 5. The method according to claim 1, wherein the growth factor is at least one of: BMP-2, rhBMP-2, BMP-4, rhBMP-4, BMP-6, rhBMP-6, BMP-7(OP-1), rhBMP-7, GDF-5, rhGDF-5, LIM mineralization protein, platelet derived growth factor (PDGF), transforming growth factor-.beta.(TGF-.beta.), insulin-related growth factor-I (IGF-I), insulin-related growth factor-II (IGF-II), fibroblast growth factor (FGF), beta-2-microglobulin (BDGF II), parathyroid hormone (PTH), PGE2 agonist, granulocyte colony stimulating factor (G-CSF), vascular endothelial growth factor (VEGF), and matrix metalloproteinase (MMP). 6. The method according to claim 1, wherein the depot implant is biodegradable. 7. The method according to claim 1, wherein the depot implant allows for implantation and retention into the target site of the therapeutic agent. 8. The method according to claim 1, wherein the dense scaffold is constructed from a gel. 9. The method according to claim 1, wherein the depot implant comprises polylactic acid, polygylcolic acid, or polylacticglycolic acid (PLGA). 10. The method according to claim 1, wherein the depot implant has a physical structure generally in the shape of one of a cylinder or a sphere. 11. The method according to claim 10, wherein the cylinder shape is 5 to 20 mm in length. 12. The method according to claim 10, wherein the cylinder shape is 1 to 5 mm in diameter. 13. The method according to claim 10, wherein the cylinder shape is either straight or curved. 14. The method according to claim 1, wherein administering the therapeutic agent comprises utilizing a cannula or large bore needle to inject the depot into the target site.

Details for Patent 7,923,432

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2026-05-05