Claims for Patent: 9,061,064

Summary for Patent: 9,061,064

Title:	Implantable devices for chemonucleolysis of intervertebral discs
Abstract:	Devices for the treatment of intervertebral discs are described. The devices, when implanted into the nucleus pulposus of an intervertebral disc, provide for the controlled release of active agents into the disc. The active agent can be a chemonucleolytic agent such as chymopapain. The device can also comprise one or more binders. The device can be an elongate solid body having a tapered or rounded insertion end. Alternatively, the device can include a plurality of particles.
Inventor(s):	Trieu; Hai H. (Cordova, TN)
Assignee:	Warsaw Orthopedic, Inc. (Warsaw, IN)
Application Number:	11/605,815
Patent Claims:	1. An intervertebral disc implant comprising a chemonucleolysis agent in solid powder form, a plurality of particles and a binder, wherein the implant has a solid body throughout the cross-section of the implant and when placed into the nucleus pulposus of an intervertebral disc, the implant having a sheath comprising the chemonucleolysis agent incorporated into the sheath, the implant sustainably releases the chemonucleolysis agent into the nuclear disc tissue surrounding the implant to proteolytically degrade the tissue, the chemonucleolysis agent comprises chymopapain and is incorporated into the particles. 2. The intervertebral disc implant of claim 1, wherein the particles have an average diameter of 0.1 to 500 .mu.m. 3. The intervertebral disc implant of claim 1, wherein the particles have an average diameter of 0.5 to 250 .mu.m. 4. The intervertebral disc implant of claim 1, wherein the particles have an average diameter of 1 to 100 .mu.m. 5. The intervertebral disc implant of claim 1, wherein the chemonucleolysis agent further comprises collagenase, chondroitinase-ABC and human proteolytic enzymes. 6. The intervertebral disc implant of claim 1, wherein the solid body is an elongate solid body. 7. The intervertebral disc implant of claim 1, wherein the solid body is an elongate solid body having a tapered or rounded end. 8. The intervertebral disc implant of claim 1, wherein the solid body is a microsphere. 9. The intervertebral disc implant of claim 1, wherein the solid body has a profile shape selected from the group consisting of the profile shapes depicted in FIGS. 16A, 16B, 16C, 16D, 16E, 16F, 16G, 16H, 16I, 16J, 16K, 16L, 16M, 16N and 16O. 10. The intervertebral disc implant of claim 1, wherein the solid body has a circular cross section. 11. The intervertebral disc implant of claim 1, wherein the implant comprises up to 90% by volume of the binder. 12. The intervertebral disc implant of claim 1, wherein the implant comprises from 25 to 75% by volume of the binder. 13. The intervertebral disc implant of claim 1, wherein the binder is a polymer. 14. The intervertebral disc implant of claim 1, wherein the binder is a non-resorbable polymer, a bioresorbable polymer, or a naturally occurring polymer. 15. The intervertebral disc implant of claim 1, wherein the binder is a non-resorbable polymer selected from the group consisting of polyurethanes, polysiloxanes, polymethyl methacrylate, polyethylene, polyvinyl alcohol, polyvinyl pyrrolidone, poly(2-hydroxy ethyl methacrylate), polyacrylic acid, poly(ethylene-co-vinyl acetate), polyethylene glycol, polymethacrylic acid, and polyacrylamide. 16. The intervertebral disc implant of claim 1, wherein the binder is a bioresorbable polymer selected from the group consisting of polylactides, polyglycolides, polylactide-co-glycolides, polyanhydrides, and polyorthoesters. 17. The intervertebral disc implant of claim 1, wherein the binder is a naturally occurring polymer selected from the group consisting of polysaccharides, collagens, silk, elastin, keratin, albumin, and fibrin. 18. The intervertebral disc implant of claim 1, wherein the implant further comprises a second active agent different than the chemonucleolysis agent. 19. The intervertebral disc implant of claim 18, wherein the second active agent is a pain medication or a growth factor. 20. The intervertebral disc implant of claim 18, wherein the second active agent is a pain medication selected from the group consisting of codeine, propoxyphene, hydrocodone, and oxycodone. 21. The intervertebral disc implant of claim 18, wherein the second active agent is a growth factor selected from the group consisting of a transforming growth factor-B protein, a bone morphogenetic protein, a fibroblast growth factor, a platelet-derived growth factor, and an insulin-like growth factor. 22. The implant of claim 1, wherein the solid body further comprises a hydrogel coating. 23. The implant of claim 1, further comprising an x-ray marker. 24. The implant of claim 23, wherein the x-ray marker is a bead or a thread. 25. The implant of claim 23, wherein the x-ray marker comprises barium sulfate, platinum or tantalum. 26. The implant of claim 6, wherein the elongate solid body has no cross-sectional area with a maximum dimension greater than 5 mm. 27. The implant of claim 6, wherein the elongate solid body has no cross-sectional area with a maximum dimension greater than 3 mm. 28. The implant of claim 6, wherein the elongate solid body has no cross-sectional area with a maximum dimension greater than 1 mm. 29. The implant of claim 1, wherein the implant erodes upon resorption.

Details for Patent 9,061,064

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Discure Medical, Llc	CHYMODIACTIN	chymopapain	For Injection	018663	11/10/1982		2023-08-06
Discure Medical, Llc	CHYMODIACTIN	chymopapain	For Injection	018663	08/21/1984		2023-08-06
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2023-08-06