Claims for Patent: 8,460,381

Summary for Patent: 8,460,381

Title:	Methods and devices for the treatment of intervertebral discs disorders
Abstract:	Devices for the treatment of intervertebral discs are described. The devices, when implanted into the nucleus pulposus of an intervertebral disc, are specifically configured with an inert outer layer and an inner layer containing at least one chemonucleolysis agent so as to provide a delayed and controlled release of the chemonucleolysis agent from the inner layer into the disc. The implant can be an elongated solid body having a tapered or rounded insertion end having at least one therapeutic agent in the inner layer of the implant surrounded by an outer layer of inert material.
Inventor(s):	Lee; Elaine (Santa Clara, CA)
Assignee:	Warsaw Orthopedic, Inc. (Warsaw, IN)
Application Number:	13/076,645
Patent Claims:	1. An intervertebral disc implant comprising an inner layer comprising at least one chemonucleolysis agent; and an inert outer layer disposed about the inner layer so as to fully encapsulate said inner layer, wherein said implant is configured so that release of said chemonucleolysis agent into tissue surrounding said implant is delayed until said inert outer layer bioerodes. 2. The intervertebral disc implant of claim 1, wherein the inert outer layer includes a plurality of binder particles. 3. The intervertebral disc implant of claim 2, wherein said plurality of binder particles of said inert outer layer degrades at different rates in order to prevent the release of said at least one chemonucleolysis agent from said inner layer for a predetermined amount of time. 4. The intervertebral disc implant of claim 1 further comprising a coating disposed on an outermost surface of said outer layer wherein said coating must dissolve or degrade prior to the dissolution or degradation of said inert outer layer thereby slowing down the rate of release of said at least one chemonucleolysis agent from said inner layer. 5. The intervertebral disc implant of claim 1, further comprising at least one therapeutic agent selected from the group consisting of anti-inflammatory agents, pain medication, growth factors, anti-bacterial agents and combinations thereof. 6. The intervertebral disc implant of claim 1, wherein said inner layer includes a plurality of particles and wherein at least some of the particles comprise said at least one chemonucleolysis agent. 7. The intervertebral disc implant of claim 6, wherein the particles comprising said at least one chemonucleolysis agent have an average diameter of about 0.5 to about 250 .mu.m. 8. The intervertebral disc implant of claim 1, wherein said at least one chemonucleolysis agent is selected from the group consisting of chymopapain, collagenase, chondroitinase-ABC, hyaluronidase, human proteolytic enzymes, and polycationic substances. 9. The intervertebral disc implant of claim 5, wherein said inner layer includes a plurality of particles and wherein at least some of the particles comprise said at least one therapeutic agent. 10. The intervertebral disc implant of claim 1, wherein said inner layer is a liquid, gel, hydrogel, emulsion, particulate or solid. 11. The intervertebral disc implant of claim 1, further comprising a marker for tracking the location of said intervertebral disc implant when placed into the nucleus pulposus of an intervertebral disc. 12. The intervertebral disc implant of claim 11, wherein said marker is an x-ray marker or radio-opaque marker. 13. The intervertebral disc implant of claim 5, wherein said pain medication is selected from the group consisting of codeine, propoxyphene, hydrocodone, oxycodone and combinations thereof. 14. The intervertebral disc implant of claim 5, wherein said growth factor is selected from the group consisting of a transforming growth factor-beta protein, a bone morphogenetic protein, a fibroblast growth factor, a platelet-derived growth factor, an insulin-like growth factor and combinations thereof. 15. The intervertebral disc implant of claim 12, wherein said x-ray marker comprises barium sulfate, platinum or tantalum. 16. A method for treating at least one condition of an intervertebral disc in a patient in need of such treatment, said method comprising: placing said intervertebral disc implant of claim 1 into the nucleus pulposus of an intervertebral space of said patient, wherein said placing releases said chemonucleolysis agent into the nucleus pulposus surrounding the implant after said inert outer layer bioerodes, thereby proteolytically degrading the nucleus pulposus. 17. The method of claim 16, wherein the placing of said implant into the intervertebral space comprises: inserting a needle/trocar assembly into the intervertebral space such that the inserted end of the trocar is inside the nucleus pulposus of an intervertebral disc; removing said needle; placing said implant into said trocar; pushing said implant into the nucleus pulposus of the intervertebral disc; and removing the trocar. 18. A method for treating at least one condition of an intervertebral disc in a patient in need of such treatment and tracking said implant for proper placement, said method comprising: (a) placing said intervertebral disc implant of claim 11 into an intervertebral space of said patient, (b) determining the position of said intervertebral disc implant by detecting a location of said x-ray marker or radio-opaque marker using an imaging device and determining whether said location of said implant is correct, if said implant is not in the correct location proceeding to step (c) and if said implant is in the correct location proceeding to step (d); (c) removing said implant from said intervertebral disc and reinserting said implant in a different location in said intervertebral disc from which said implant was removed and repeating step (b); and (d) allowing said outer layer of said implant to bioerode and release said chemonucleolysis agent in said inner layer to the nucleus pulposus surrounding said implant, thereby treating said condition of said patient. 19. The method of claim 18, wherein the placing of said implant into the intervertebral space of step (a) comprises inserting a needle/trocar assembly into the intervertebral space such that the inserted end of the trocar is inside the nucleus pulposus of an intervertebral disc; removing said needle; placing said implant into said trocar; pushing said implant into the nucleus pulposus of the intervertebral disc and determining the position of said intervertebral disc implant by detecting the position according to step (b); and removing the trocar upon the completion of step (d). 20. The method of claim 18 wherein said implant further comprises at least one therapeutic agent selected from the group consisting of anti-inflammatory agents, pain medication, growth factors, anti-bacterial agents and combinations thereof. 21. The intervertebral disc implant of claim 1, wherein said inner layer comprises a hydrogel.

Details for Patent 8,460,381

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Discure Medical, Llc	CHYMODIACTIN	chymopapain	For Injection	018663	11/10/1982		2039-02-26
Discure Medical, Llc	CHYMODIACTIN	chymopapain	For Injection	018663	08/21/1984		2039-02-26
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	05/05/2004		2039-02-26
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	12/02/2004		2039-02-26
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10/26/2004		2039-02-26
Akorn, Inc.	HYDASE	hyaluronidase	Injection	021716	10/25/2005		2039-02-26