Implantable prosthetic devices containing timed release therapeutic agents

• US 20050260247A1
• Filed: 05/23/2005
• Published: 11/24/2005
• Est. Priority Date: 07/22/2002
• Status: Active Grant

• Current Assignee: New Amsterdam LLC
• Original Assignee: Biodynamics LLC (GreenGro Technologies, Inc.)
• Inventors: Ralph, James D., Tatar, Stephen L.
• Granted Patent: US 7,824,699 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• 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 2300/604 Biodegradation
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

Bioabsorbable drug delivery devices including modular drug delivery devices having shapes and sizes adapted to be inserted within a recess on the surface of an implantable prosthesis are disclosed. The devices may be attached to one another to create custom drug delivery devices having controllable drug release characteristics that depend on the composition of individual modules comprising the device. The modules may be cylinders, disks, tiles or tubes comprised of a bioabsorbable polymer and a therapeutic agent. The therapeutic agent(s) may be homogeneously distributed throughout the polymeric body of the device or contained within a cavity within a module comprising the device, or both. The device(s) may be threaded or attached to a prosthesis by a biodegradable adhesive. The modular devices may also be formed into tapered plugs for insertion into a mating receptacle. In another embodiment, the drug delivery device may be inserted within a mesh bag that may be attached to a soft tissue as, for example, by sutures, for localized controlled dispensation of a therapeutic agent.

Claims

1. An implantable prosthetic device comprising an implantable prosthesis and a drug delivery device installed in the prosthesis, the implantable prosthesis having an outer surface contour and the installed drug delivery device having a solid outer surface and an outer surface contour, the drug delivery device being installed within a recess in the outer surface contour of the implantable prosthesis whereby the outer surface contour of the installed drug delivery device generally follows the outer surface contour of the implantable prosthesis, the drug delivery device being operable for releasing a therapeutic agent into the body of an animal following implantation of the prosthetic device within the body of the animal, the drug delivery device comprising a biodegradable polymer and a therapeutic agent, the therapeutic agent being released into the body of the animal during biodegradation of the biodegradable polymer over a predefined dosing period.

2. The implantable prosthetic device of claim 1 further comprising a radiopaque material.

3. The implantable prosthetic device of claim 1 further comprising a tissue augmentation material.

4. The implantable prosthetic device of claims 1, 2 or 3 wherein the therapeutic agent is selected from the group consisting of antiseptics, antibiotics, analgesics and lactoferrin.

5. The implantable prosthetic device of claim 1 having at least two therapeutic agents, each agent having at least one predefined dosing period.

6. The implantable prosthetic device of claim 1 wherein the therapeutic agent is encapsulated in the biodegradable polymer.

7. The implantable prosthetic device of claim 1 wherein the therapeutic agent is disposed within a modular plug containing more than one bioabsorbable polymer.

8. The implantable prosthetic device of claim 1 wherein the drug delivery device is a rigid, preshaped polymeric plug.

9. The implantable prosthetic device of claim 7 wherein the modular plug has a shape selected from the group consisting of a cylinder, disc, rod, capsule, plurality of stacked discs, O-ring, plurality of stacked O-rings, rectangular plaque, capped tube, tapered conical plug and threaded cylindrical plug.

10. The implantable prosthetic device of claim 1 wherein the drug delivery device comprises a plurality of stacked annular modules affixed to one another.

11. The implantable prosthetic device of claim 1 wherein the drug delivery device comprises a plurality of stacked tubular modules affixed to one another end to end.

12. The implantable prosthetic device of claim 1 wherein the drug delivery device comprises a sealable capsule.

13. The implantable prosthetic device of claim 1 wherein the drug delivery device comprises a capsular drug delivery module disposed within an implantable mesh bag.

14. The implantable prosthetic device of claim 1 wherein the outer surface of the drug delivery device comprises a disc affixed over the recess to the outer surface of the prosthesis.

15. The implantable prosthetic device of claim 1 wherein the recess comprises a hole or opening in the prosthesis, said hole or opening being disposed at or near a break in a bone of the animal.

16. A method for controlled release of a therapeutic agent into an orthopaedic surgical site over a predefined dosing period comprising providing an implantable prosthetic device of claim 1 and implanting the prosthetic device in the body of an animal.