IP Library Granted Patent US 8,062,364
Granted Patent B1
US 8,062,364 · App. 12/110,434 · Granted Nov 22, 2011

Osteoarthritis treatment and device

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Quick Facts
Patent No.
US 8,062,364
App. No.
12/110,434
Granted
Nov 22, 2011
Kind
B1
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 (48)

1. A method for subchondrally treating arthritis of a joint, wherein the method stabilizes the bone in order to prevent further biomechanical breakdown of the bone and of adjacent meniscal tissues, and alleviates pain in the joint, said method comprising:

identifying a bone marrow lesion in a subchondral portion of a bone adjacent to the joint based on a magnetic resonance imaging of the joint;

determining a grade for the bone marrow lesion based on the size of the bone marrow lesion identified in the magnetic resonance image;

determining, after identifying the bone lesion, an extent of treatment based on a size of the at least one bone marrow lesion;

selecting at least one reinforcing member in accordance with the grade for the bone marrow lesion;

creating, in said bone that contains the bone marrow lesion in its subchondral portion, subchondral access into an area in or adjacent to the bone marrow lesion, while preserving the articular surface of said bone, the articular surface being substantially over the subchondral portion of said bone that contains the bone marrow lesion; and

implanting in the subchondral portion of said bone the selected at least one reinforcing member in or adjacent to the bone marrow lesion via the subchondral access.

2. The method of claim 1 , wherein the joint is a knee of a human.

3. The method of claim 1 , wherein the bone marrow lesion is less than 1 cm from the joint.

4. The method of claim 1 , wherein the at least one reinforcing member is planar and comprises:

a proximal face facing the joint;

a distal face facing away from the joint; and

a wedge-shaped edge adapted to pierce the bone.

5. The method of claim 4 , wherein the at least one reinforcing member comprises a metal.

6. The method of claim 4 , wherein a maximum dimension of the proximal face exceeds a maximum dimension of the bone marrow lesion.

7. The method of claim 4 , wherein the proximal face is larger than the bone marrow lesion.

8. The method of claim 4 , wherein the proximal face and the distal face are rectangular, circular or triangular.

9. The method of claim 1 , wherein the implanting comprises positioning the at least one reinforcing member so as to be perpendicular to a longitudinal axis of the bone.

10. The method of claim 9 , wherein the at least one reinforcing member is implanted within the bone marrow lesion.

11. The method of claim 9 , wherein the at least one reinforcing member is implanted outside the bone marrow lesion and from 0 to 1 cm from a distal surface of the bone marrow lesion relative to the joint.

12. The method of claim 1 , wherein the implanting comprises injecting a fluid into the bone and curing the fluid to form the at least one reinforcing member in situ.

13. The method of claim 12 , wherein the at least one reinforcing member is a solid, a semi-solid or a gel.

14. The method of claim 12 , wherein the at least one reinforcing member is implanted within the bone marrow lesion.

15. The method of claim 12 , wherein the at least one reinforcing member is implanted outside the bone marrow lesion and from 0 to 1 cm from a distal surface of the bone marrow lesion relative to the joint.

16. The method of claim 1 , wherein: (a) the bone marrow lesion has a diameter less than 1 mm, and the at least one reinforcing member is a resorbable graft material; (b) the bone marrow lesion has a diameter of 1-3 mm and the at least one reinforcing member is a semi-structural graft material; (c) the bone marrow lesion has a diameter of 3-5 mm and the at least one reinforcing member is a non-resorbing support; or (d) the bone marrow lesion has a diameter greater than 5 mm and the at least one reinforcing member is a permanent structural implant.

17. The method of claim 1 , further comprising applying electrical stimulation to the bone to promote bone healing.

18. The method of claim 1 , further comprising selecting the at least one reinforcing member in accordance with a grading system that indicates an extent of treatment for the at least one reinforcing member, after the determining step.

19. The method of claim 1 , wherein preserving the articular surface of said bone comprises preserving a cartilage surface portion of said articular surface of said bone.

20. The method of claim 1 , wherein determining the grade for the bone marrow lesion comprises determining the grade based on a grading system that comprises respective grades corresponding to ranges of bone marrow lesion sizes.

21. The method of claim 20 , wherein the grading system comprises a grade corresponding to bone marrow lesions less than about 1 mm in size.

22. The method of claim 20 , wherein the grading system comprises a grade corresponding to bone marrow lesions that are about 1-3 mm in size.

23. The method of claim 20 , wherein the grading system comprises a grade corresponding to bone marrow lesions that are about 3-5 mm in size.

24. The method of claim 20 , wherein the grading system comprises a grade corresponding to bone marrow lesions that are greater than about 5 mm in size.

25. A method for subchondrally treating joint pain, where pain is associated with a presence of at least one bone marrow lesion in a subchondral region of a bone adjacent to a joint, and wherein the method stabilizes the bone in order to prevent further biomechanical breakdown of the bone and of adjacent meniscal tissues, and alleviates pain in the joint, said method comprising:

identifying the at least one bone marrow lesion in the subchondral region of the bone adjacent to the joint based on magnetic resonance imaging of the joint;

determining an extent of treatment in accordance with a grading system that is based on a size of the at least one of the bone marrow lesions identified in the magnetic resonance image of the joint;

selecting at least one reinforcing member based on the extent of treatment indicated by the grading system;

creating, in said bone that contains the at least one bone marrow lesion in its subchondral region, subchondral access into an area in or adjacent to the at least one bone marrow lesion, while preserving the articular surface of said bone, the articular surface being substantially over the subchondral portion of said bone that contains the at least one bone marrow lesion; and

implanting in the subchondral region of said bone at least one reinforcing member in or adjacent to the at least one bone marrow lesion via the subchondral access.

26. The method of claim 25 , wherein the implanting step comprises a use of real-time imaging.

27. The method of claim 25 , wherein the implanting step comprises injecting a fluid into the bone to form the at least one reinforcing member in situ.

28. The method of claim 25 , wherein the at least one reinforcing member is a solid or a non-fluid material.

29. The method of claim 25 , wherein preserving the articular surface of said bone comprises preserving a cartilage surface portion of said articular surface of said bone.

30. The method of claim 25 , wherein determining the extent of treatment in accordance with the grading system comprises determining the grade based on a grading system having grades corresponding to ranges of bone marrow lesion sizes.

31. The method of claim 30 , wherein the grading system comprises a grade corresponding to bone marrow lesions less than about 1 mm in size.

32. The method of claim 30 , wherein the grading system comprises a grade corresponding to bone marrow lesions that are about 1-3 mm in size.

33. The method of claim 30 , wherein the grading system comprises a grade corresponding to bone marrow lesions that are about 3-5 mm in size.

34. The method of claim 30 , wherein the grading system comprises a grade corresponding to bone marrow lesions that are greater than about 5 mm in size.

Assignments (11)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 28, 2014
From: SUBCHONDROPLASTY ORTHOPEDICS, LLC
To: ZIMMER GMBH
Reel/Frame 032977/0494 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 16, 2013
From: ZIMMER GMBH
To: ZIMMER KNEE CREATIONS, INC.
Reel/Frame 031788/0899 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE NAME PREVIOUSLY RECORDED ON REEL 030642 FRAME 0595. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNEE NAME SHOULD READ AS ZIMMER GMBH. Recorded Nov 27, 2013
From: KNEE CREATIONS, LLC
To: ZIMMER GMBH
Reel/Frame 031736/0479 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 19, 2013
From: KNEE CREATIONS, LLC
To: ZIMMER GMBH, INC.
Reel/Frame 030642/0595 →
SECURITY AGREEMENT Recorded May 14, 2013
From: DDLCOL, LLC
To: SUBCHONDROPLASTY ORTHOPEDICS, LLC FORMERLY KC ORTHOPEDIC TECHNOLOGIES, LLC
Reel/Frame 030409/0766 →
SECURITY AGREEMENT Recorded May 14, 2013
From: DDLCOL, LLC
To: KNEE CREATIONS, LLC
Reel/Frame 030409/0778 →
CHANGE OF NAME Recorded Nov 30, 2012
From: KC ORTHOPEDIC TECHNOLOGIES, LLC
To: SUBCHONDROPLASTY ORTHOPEDICS, LLC
Reel/Frame 029383/0940 →
SECURITY AGREEMENT Recorded May 22, 2012
From: KC ORTHOPEDIC TECHNOLOGIES, LLC
To: DDLCOL, LLC
Reel/Frame 028246/0635 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 24, 2012
From: KNEE CREATIONS, LLC
To: KC ORTHOPEDIC TECHNOLOGIES, LLC
Reel/Frame 028095/0312 →
SECURITY AGREEMENT Recorded Jul 19, 2011
From: KNEE CREATIONS, LLC
To: DDLCOL, LLC, AS COLLATERAL AGENT
Reel/Frame 026616/0765 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 29, 2009
From: SHARKEY, PETER F.; LEINBERRY, CHARLES F.
To: KNEE CREATIONS, LLC
Reel/Frame 023714/0030 →