Bioabsorbable plugs containing drugs

• US 6,916,483 B2
• Filed: 07/22/2002
• Issued: 07/12/2005
• Est. Priority Date: 07/22/2002
• Status: Expired due to Term

• Current Assignee: New Amsterdam LLC
• Original Assignee: Biodynamics LLC (GreenGro Technologies, Inc.)
• Inventors: Tatar, Steve, Ralph, James
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Sheikh, Humera N.
• Application Number:
  US10/200,355
• Publication Number:
  US 20040013703A1
• Time in Patent Office: 1,086 Days
• Field of Search: 424/422, 424/426, 623/23.75, 623/23.76
• US Class Current: 424/422
• 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: 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 modular drug delivery devices having shapes and sizes adapted to be inserted within a mating receptacle 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 having a surface contour, and comprising a solid modular implantable drug delivery device within a shaped recess within the outer surface of an implantable prosthesis, said device being operable for releasing a therapeutic agent into the body of an animal following implantation of the prosthesis within the body of the animal, the device comprising:

(a) solid module comprising a biodegradable polymer dimensioned to fit snugly within the shaped recess in the prosthesis; and

(b) a therapeutic agent that is released into the body of the animal during biodegration of said biodegradable polymer over a predefined dosing period.

2. The device of claim 1 wherein when said solid module comprising a biodegradable polymer is received within the shaped recess of the implantable prosthesis, the contour of the outer surface of the prosthesis is not substantially altered.

3. The device of claim 1 wherein said solid module comprising a biodegradable polymer is affixed to said prosthesis.

4. The device of claim 2 wherein said solid module comprising a biodegradable polymer is affixed to said prosthesis.

5. The device of claim 1 wherein said therapeutic agent is contained within a cavity in said solid module.

6. The device of claim 2 wherein said therapeutic agent is contained within a cavity in said solid module.

7. The device of claim 1 comprising a plurality of solid modules.

8. The device of claim 7 wherein said plurality of solid modules are affixed to one another.

9. The implantable prosthetic device of claim 1 comprising:

(a) a mesh container;

and (b) at least one solid module comprising a biodegradable polymer and a therapeutic agent contained within, said mesh container.

10. The implantable prosthetic device of claim 1 wherein the prosthesis is a femoral pin.

11. The implantable prosthetic device of claim 1 wherein the prosthesis is a bone plate.

12. The implantable prosthetic device of claim 11, wherein the solid module is shaped like a rectangular tile, and the recess is a mating receptacle therefor.

13. The implantable prosthetic device of claim 1 wherein the recess is formed by drilling a hole in the prosthesis.

14. The implantable prosthetic device of claim 1, wherein the solid module is shaped like a rod, and is placed, within a cylindrical recess in the prosthesis.

15. The implantable prosthetic device of claim 7, wherein one of the solid modules is hollowed out to increase the surface area in contact with the body fluids, and increase the rate of release of a therapeutic agent therefrom.

16. The implantable prosthetic device of claim 1, wherein the solid module is shaped like a tapered conical plug.

17. The implantable prosthetic device of claim 1, wherein the solid module is shaped like a threaded cylindrical plug.

18. The implantable prosthetic device of claim 7, wherein the modules comprise a plurality of stacked disks.

19. The implantable prosthetic device of claim 1, wherein the solid module is shaped like a capped tub.

20. A method for controlled phased release of a therapeutic agent into an orthopedic surgical site, comprising providing an implantable prosthesis, forming at least one shaped solid modular drug delivery device comprising a biodegradable polymer and a therapeutic agent, forming a recess in the surface of the prosthesis shaped to receive the shaped solid modular drug delivery device, placing at least one shaped solid modular drug delivery device in the recess, and implanting the prosthesis in the body of an animal.