Methods for the in situ treatment of bone cancer
The present invention relates to methods for in situ treatment of malignant cells from a cancer associated with bone. In one method, the treatment is for a primary cancer and entails positioning an implant containing and/or coated with at least one active agent for treating malignant cells directly in/on or indirectly among/near (e.g., by placing the implant in an area immediately proximal to) a site containing the malignant cells. In another method, the treatment includes positioning an implant containing and/or coated with at least one active agent for treating malignant cells directly in/on or indirectly among/near (e.g., by placing the implant in an area immediately proximal to) a surgical site from which malignant cells were previously removed/excised.
1. A medical device for the in situ treatment of malignant cells from a cancer associated with bone, comprising:
a sterile, coated implant comprising
an implant defining an outer surface, the implant associated with a bone injury, and the outer surface of the implant being non-porous, non-absorbent in water or an organic liquid, or non-swellable in water or an organic liquid;
a polymer coating layer at least partially covering the outer surface having an average thickness of at least about 250 microns to about 1000 microns; and
an active agent suitable for the treatment of the malignant cells, wherein the active agent associates with the polymer coating layer.
2. The medical device of claim 1 , wherein the implant outer surface comprises a metal or metal alloy.
3. The medical device of claim 2 , wherein the implant is a screw, tack, nail, pin, plate, or rod.
4. The medical device of claim 1 , wherein the polymer coating layer is biodegradable.
5. The medical device of claim 1 , wherein the polymer coating layer has an average thickness from about 500 microns to about 1 mm.
6. The medical device of claim 5 , wherein the thickness of the polymer coating layer is non-uniform across the sterile coated implant.
7. The medical device of claim 1 wherein the polymer coating layer is porous.
8. The medical device of claim 1 , wherein the active agent at least partially chemically associates with the polymer coating layer.
9. The medical device of claim 1 , wherein the active agent at least partially physically associates with the polymer coating layer.
10. The medical device of claim 8 , wherein the active agent at least partially physically associates with the polymer coating layer.
11. The medical device of claim 1 , wherein the active agent includes an antibacterial agent, an antiviral agent, an osseointegrative agent, an osteoinductive agent, an osteoconductive agent, or a combination thereof.
12. A medical device kit for the in situ treatment of bone cancer comprising:
(a) a sterile coated implant having an outer surface wherein a polymer coating layer at least partially covers the outer surface the coating having an average thickness of at least about 250 microns to about 1000 microns, the implant associated with a bone injury;
wherein the outer surface of the implant is non-porous, non-absorbent in water or an organic liquid, or non-swellable in water or an organic liquid,
wherein the sterile coated implant is free of active agent; and
(b) a sterile carrier comprising an active agent suitable for the treatment of bone cancer, wherein the sterile carrier is adapted to facilitate at least a partial chemical or physical association, or both, between the active agent and the polymer coating layer.
13. The medical device kit of claim 12 , wherein the implant outer surface comprises a metal or metal alloy.
14. The medical device kit of claim 13 , wherein the implant is a screw, tack, nail, pin, plate, or rod.
15. The medical device kit of claim 12 , wherein the polymer coating layer is biodegradable.
16. The medical device kit of claim 12 , wherein the polymer coating layer has a thickness from about 10 nm to about 1 mm.
17. The medical device kit of claim 16 , wherein the thickness of the polymer coating layer is non-uniform across the sterile coated implant.
18. The medical device kit of claim 12 , wherein the polymer coating layer is porous.
19. The medical device kit of claim 12 , wherein the active agent includes an antibacterial agent, an antiviral agent, an osseointegrative agent, an osteoinductive agent, an osteoconductive agent, or a combination thereof.
20. The medical device kit of claim 12 , wherein the sterile carrier is adapted to facilitate at least a partial chemical association between the active agent and the polymer coating layer.