Osteoarthritis treatment and device

• US 8,574,303 B2
• Filed: 10/14/2011
• Issued: 11/05/2013
• Est. Priority Date: 04/27/2007
• Status: Active Grant

• Current Assignee: Zimmer Knee Creations, Inc. (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer GmbH (Zimmer Biomet Holdings, Inc.)
• Inventors: Sharkey, Peter F., Leinberry, Charles F.
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): BLANCO, JAVIER G
• Application Number:
  US13/273,912
• Publication Number:
  US 20120035673A1
• Time in Patent Office: 753 Days
• Field of Search: None
• US Class Current: 623/20.14
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/8825 characterised by syringe details A61B17/8822, A61B17/8827 take precedence
• CPC Class Codes: A61B 2017/00933 bone or bone-like
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/4504 Bones A61B5/4547 takes precedence
• CPC Class Codes: A61B 5/4585 Evaluating the knee
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/2892 Tibia
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00131 Tantalum or Ta-based alloys
• CPC Class Codes: A61L 24/02 containing inorganic materials
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/12 Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: A61L 27/50 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: Y10S 623/908 : Bone

Abstract

A method for treating arthritis of a joint includes identifying a bone lesion in a bone adjacent to the joint; and implanting in the bone a reinforcing member in or adjacent to the bone lesion. A kit for conducting the method includes: (a) at least one reinforcing member having a proximal face adapted to face the joint, a distal face adapted to face away from the joint, and a wedge-shaped edge adapted to pierce bone, wherein the at least one reinforcing member is planar and sterile; and (b) a container adapted to maintain the at least one reinforcing member sterile. Another kit includes: (a) a sterile fluid; (b) a syringe for injecting the fluid into a bone; (c) a curing agent adapted to cure the fluid to polymerize and/or cross-link; and (d) a container adapted to maintain the sterility of contents of the container.

Claims

1. A method of subchondrally treating pain associated with a subchondral defect of a knee joint with arthritis, the defect being attributed to overstressed bone as a result of a biomechanical breakdown of the bone or adjacent meniscal tissues, said method comprising:

identifying a defect in a subchondral region of a bone of the joint based on capturing an image of said joint;

determining, after identifying the defect, an extent of treatment based on size and shape of the defect;

selecting at least one reinforcing member;

creating, in said bone that contains the defect in its subchondral region, subchondral access into an area in or adjacent to the defect, while preserving an existing condition of the articular surface residing substantially over the subchondral region of said bone that contains the subchondral defect;

implanting in the subchondral region of said bone the selected at least one reinforcing member in or adjacent to the subchondral defect via the subchondral access; and

surgically stabilizing the defect in a manner that enhances the strength of the overstressed bone, the surgery being conducted with the use of guidance consistent with the image of said joint;

wherein the stabilization alleviates corresponding pain in the joint.

2. The method of claim 1, further including the use of imaging labels.

3. The method of claim 2, wherein the imaging labels comprises radioactive labels.

4. The method of claim 1, further including the use of visual markers.

5. The method of claim 4, wherein the visual markers comprise fiducial markers.

6. The method of claim 1, wherein the step of identifying comprises magnetic resonance imaging.

7. The method of claim 1, wherein the step of identifying comprises a bone scan.

8. The method of claim 1, wherein the step of surgically stabilizing includes use of real-time imaging.

9. The method of claim 1, wherein the step of surgically stabilizing includes use of robotic devices.

10. The method of claim 1, wherein stabilizing the defect allows the overstressed bone to achieve more repair of bone tissue than damage under normal use.

11. The method of claim 1, wherein the step of surgically stabilizing includes use of mechanical braces.

12. The method of claim 1, wherein the defect comprises a bone marrow lesion.

13. The method of claim 1, wherein the overstressed bone comprises bone tissue that sustains more damage than repair under normal use.

14. The method of claim 1, wherein the at least one reinforcing member is selected in accordance with the size of the defect.

15. The method of claim 1, wherein stabilizing the defect reduces, reverses, or prevents deformation of the overstressed bone.

16. The method of claim 1, wherein stabilizing the defect slows the progression of arthritis.

17. The method of claim 1, wherein stabilizing the defect prevents further biomechanical breakdown of the bone or of adjacent meniscal tissues.

18. The method of claim 1, wherein the at least one reinforcing member is formed of a solid, a semi-solid or a gel material.

19. The method of claim 1, wherein the at least one reinforcing member is implanted by driving the member into the bone.

20. The method of claim 1, wherein the at least one reinforcing member is implanted within the defect.

21. The method of claim 1, wherein the at least one reinforcing member is formed in situ by injecting a fluid into the bone and curing the fluid.

22. The method of claim 1, wherein the at least one reinforcing member comprises a metallic, polymeric, autograft, allograft, artificial or synthetic bone substitute material.

23. The method of claim 1, wherein the at least one reinforcing member is osteogenic, osteoconductive or osteoinductive.

24. The method of claim 1, wherein the at least one reinforcing member is resorbable.

25. The method of claim 1, wherein preserving an existing condition of an articular surface of said bone comprises preserving an existing condition of a cartilage surface portion of said articular surface of said bone.

26. The method of claim 1, wherein the step of creating subchondral access comprises creating a channel in said bone.

27. The method of claim 26, wherein the step of creating a channel comprises use of tools for creating said channel in said bone.

28. The method of claim 1, wherein the at least one reinforcing member comprises a calcium phosphate.

29. A method of subchondrally treating pain associated with a subchondral defect of a knee joint with arthritis, the defect being attributed to overstressed bone as a result of a biomechanical breakdown of the bone or adjacent meniscal tissues, said method comprising:

identifying a defect in a subchondral region of a bone of the joint based on capturing an image of said joint;

determining, after identifying the defect, an extent of treatment based on size and shape of the defect;

selecting at least one reinforcing member;

creating, in said bone that contains the defect in its subchondral region, subchondral access into an area in or adjacent to the defect, while preserving an existing condition of the articular surface residing substantially over the subchondral region of said bone that contains the subchondral defect;

implanting in the subchondral region of said bone the selected at least one reinforcing member in or adjacent to the subchondral defect via the subchondral access; and

surgically stabilizing the defect in a manner that enhances the strength of the overstressed bone, the surgery being conducted with the use of real-time imaging of said joint;

wherein the stabilization alleviates corresponding pain in the joint.