SUBCHONDRAL TREATMENT OF JOINT PAIN

• US 20110125157A1
• Filed: 11/19/2010
• Published: 05/26/2011
• Est. Priority Date: 11/20/2009
• Status: Active Grant

• Current Assignee: Zimmer Knee Creations, Inc. (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Knee Creations, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Cohen, Steven B., Erbe, Erik M., Bagga, Charanpreet S., Leinberry, Charles F., Sharkey, Peter F.
• Granted Patent: US 8,951,261 B2
• Time in Patent Office: Days
• US Class Current: 606/92
• CPC Class Codes: A61B 17/1637 Hollow drills or saws producing a curved cut, e.g. cylindrical A61B10/025, A61B17/1695 take precedence
• CPC Class Codes: A61B 17/1697 specially adapted for wire insertion
• CPC Class Codes: A61B 17/17 Guides or aligning means for drills , mills, pins or wires
• CPC Class Codes: A61B 17/1742 for the hip
• CPC Class Codes: A61B 17/1764 for the knee
• CPC Class Codes: A61B 17/1775 for the foot or ankle
• CPC Class Codes: A61B 17/1778 for the shoulder
• 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 17/8802 Equipment for handling bone cement or other fluid fillers
• 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 17/8872 Instruments for putting said fixation devices against or away from the bone A61B17/7074, A61B17/808 take precedence
• CPC Class Codes: A61B 17/8897 Guide wires or guide pins
• CPC Class Codes: A61B 17/90 Guides therefor
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

The embodiments provide devices and methods that both strengthen the bone and stimulate the bone. Bone fractures or non-unions are stabilized, integrated or healed, which results in reduction of a bone defect, such as a bone marrow lesion or edema. In addition, the distribution of forces in a joint are restored or altered to relieve pain. In general, a joint is evaluated by taking an image of the joint and one or more subchondral defects are detected. At least one of the subchondral defects may be diagnosed as the source of pain and an extent of treatment for the subchondral defect is determined. The disclosed devices and techniques are particularly suited for treating chronic defects or injuries, where the patient'"'"'s natural healing response has not resolved the defect. The present disclosure also provides several exemplary treatment modalities for the different extents of treatment needed.

Claims

1. A method for treating joint pain comprising:

identifying a subchondral defect in a subchondral region of a bone of the joint;

selecting a subchondral access path to a location near the subchondral defect; and

treating the subchondral defect, via the subchondral access, in a manner that restores normal force distribution and joint function while preserving the articular surface of the bone.

2. The method of claim 1, wherein the step of identifying comprises detection of the subchondral defect based on an image of the joint.

3. The method of claim 2, wherein the image is a magnetic resonance image or x-ray.

4. The method of claim 1, wherein the step of identifying comprises detection of the subchondral defect by manual palpation of the joint.

5. The method of claim 1, wherein the step of identifying comprises detection of the subchondral defect by chemical or biological assay.

6. The method of claim 1, wherein the subchondral defect is a bone marrow lesion or a bone marrow edema.

7. The method of claim 6, wherein the subchondral defect further includes sclerotic bone.

8. The method of claim 6, wherein the bone marrow lesion or bone marrow edema is identified based on a T2-weighted magnetic resonance image of the joint.

9. The method of claim 7, wherein the sclerotic bone is identified based on a T1-weighted magnetic resonance image of the joint.

10. The method of claim 6, wherein the subchondral defect further includes a fracture.

11. The method of claim 1, further including the step of determining that the subchondral defect is a result of a chronic structural defect in bone tissue of the joint that causes an abnormal force distribution in the joint or a chronic deficit of healing in the bone tissue, prior to treating the subchondral defect.

12. The method of claim 6, further including the step of determining that the bone marrow lesion or bone marrow edema is a result of a chronic, abnormal distribution of forces between sclerotic bone and cancellous bone tissue in the bone, prior to treating the subchondral defect.

13. The method of claim 1, wherein selecting a subchondral access path comprises identifying a location of the subchondral defect based on an anatomical reference of the bone.

14. The method of claim 13, wherein the subchondral access path is determined using a guide instrument that provides a set of tool guiding portals for targeting the location of the subchondral defect.

15. The method of claim 13, wherein the subchondral access path is determined using a mapping system that provides a set of coordinates for targeting the location of the subchondral defect.

16. The method of claim 13, wherein the subchondral access path is determined using a template for targeting the location of the subchondral defect.

17. The method of claim 1, wherein treating the subchondral defect comprises mechanically stabilizing the defect.

18. The method of claim 1, wherein treating the subchondral defect comprises stimulating a healing response to heal the defect.

19. The method of claim 17, wherein treating the subchondral defect comprises implanting in the bone, via the subchondral access, an implantable device that structurally supports the defect.

20. The method of claim 19, wherein the implantable device is configured to sufficiently alter forces applied on the subchondral defect.

21. The method of claim 17, wherein treating the subchondral defect comprises injecting in the bone, via the subchondral access, a bone hardening material.

22. The method of claim 21, wherein the bone hardening material comprises a bone cement, bone void filler, or bone substitute material.

23. The method of claim 21, wherein treating the subchondral defect comprises injecting a sufficient volume of the bone hardening material to envelope the subchondral defect.

24. The method of claim 21, wherein the bone hardening material further stimulates a healing response to heal the subchondral defect.

25. The method of claim 18, wherein stimulating a healing response comprises drilling.

26. The method of claim 18, wherein stimulating a healing response comprises electrical or heat stimulation.

27. The method of claim 18, wherein stimulating a healing response comprises biological or chemical stimulation.

28. The method of claim 1, further including treating the articular surface of the joint.

29. The method of claim 28, wherein treating the articular surface comprises resurfacing the articular surface.

30. The method of claim 28, wherein treating the articular surface comprises regenerating new tissue on the articular surface.

31. The method of claim 28, wherein treating the articular surface comprises plugging a void on the articular surface.

32. The method of claim 1, wherein treating the subchondral defect comprises compacting bone tissue to create a void in or adjacent to the subchondral defect.

33. A method for treating joint pain comprising:

identifying a subchondral defect in a subchondral region of a bone of the joint;

selecting a subchondral access path to a location near the subchondral defect; and

treating the subchondral defect, via the subchondral access, by mechanically stabilizing an area in or near the subchondral defect;

wherein treatment of the subchondral defect restores normal force distribution and joint function while preserving an articular surface of the bone.

34. The method of claim 33, wherein treating comprises implanting in the bone an implant to sufficiently alter forces applied on the subchondral defect.

35. The method of claim 34, further including the step of drilling prior to implanting.

36. The method of claim 34, further including the step of compacting bone tissue prior to implanting.

37. The method of claim 33, further including the step of stimulating a healing of the bone tissue in or adjacent to the subchondral defect.

38. The method of claim 33, wherein treating comprises injecting a bone hardening material via the subchondral access.

39. The method of claim 38, wherein the bone hardening material comprises bone cement, bone void filler, or bone substitute material.

40. A method for treating joint pain comprising:

identifying a subchondral defect in a subchondral region of a bone of the joint;

selecting a subchondral access path to a location near the subchondral defect; and

treating the subchondral defect, via the subchondral access, by stimulating healing of the bone tissue in or adjacent to the subchondral defect;

wherein treatment of the subchondral defect restores normal force distribution and joint function while preserving the articular surface of the bone.

41. The method of claim 40, wherein stimulating healing of the bone tissue comprises drilling into the bone tissue via the access path.

42. The method of claim 40, wherein stimulating healing of the bone tissue comprises applying electrical or heat stimulation.

43. The method of claim 40, wherein stimulating healing of the bone tissue comprises applying biological or chemical stimulation.

44. The method of claim 40, wherein stimulating healing of the bone tissue comprises injection of a bone growth inducing material.

45. A kit for treating joint pain comprising:

an implant for mechanical stabilization of a subchondral defect in a subchondral region of a bone adjacent to the joint;

a delivery tool for the implant; and

an instrument for guiding the tool to a target location in the bone, the instrument comprising;

a first portion having a first guide section configured to guide the tool to the target location;

a reference probe extending from the first portion having a tip that indicates a selected landmark on the bone; and

a handle portion coupled to the first portion and having a second guide section configured to guide a tool to the target location;

wherein the first guide section is configured to guide the tool at an angle substantially parallel to the reference probe, and the second guide section is configured to guide the tool at an angle acute to the reference probe.

46. The kit of claim 45, wherein the guide sections comprise one or more openings for insertion of the tool therethrough.

47. The kit of claim 45, wherein the reference probe is configured to rest against an anatomical landmark on the bone adjacent to the joint.

48. The kit of claim 45, wherein the openings are configured to guide the tool into the subchondral region of the bone.

49. The kit of claim 45, wherein the instrument is a unitary body.

50. The kit of claim 45, wherein the handle portion is configured to be detachable from the instrument.

51. The kit of claim 45, wherein the handle portion is configured with a radius of curvature that provides a plurality of acute angles of approach to the target location.

52. The kit of claim 45, wherein the handle portion comprises an adjustable arm that provides an adjustable set of angles of approach to the target location.

53. The kit of claim 45, further including an injector tool containing a volume of bone hardening material.

54. The kit of claim 53, wherein the bone hardening material is a bone cement, a bone void filler, or a bone substitute material.

55. A kit for treating joint pain comprising:

an injectable material for biological stimulation of a healing response to a subchondral defect in a subchondral region of a bone adjacent to the joint;

an injector tool for delivery of the material; and

an instrument for guiding the tool to a target location in the bone, the instrument comprising;

a first portion having a first guide section configured to guide the tool to the target location;

a reference probe extending from the first portion having a tip that indicates a selected landmark on the bone; and

a handle portion coupled to the first portion and having a second guide section configured to guide a tool to the target location;

wherein the first guide section is configured to guide the tool at an angle substantially parallel to the reference probe, and the second guide section is configured to guide the tool at an angle acute to the reference probe.

56. The kit of claim 55, wherein the guide sections comprise one or more openings for insertion of the tool therethrough.

57. The kit of claim 55, wherein the reference probe is configured to rest against an anatomical landmark on the bone adjacent to the joint.

58. The kit of claim 55, wherein the openings are configured to guide the tool into the subchondral region of the bone.

59. The kit of claim 55, wherein the instrument is a unitary body.

60. The kit of claim 55, wherein the handle portion is configured to be detachable from the instrument.

61. The kit of claim 55, wherein the handle portion is configured with a radius of curvature that provides a plurality of acute angles of approach to the target location.

62. The kit of claim 55, wherein the handle portion comprises an adjustable arm that provides an adjustable set of angles of approach to the target location.

63. The kit of claim 55, further including a drilling tool for drilling into the subchondral region.

64. The kit of claim 55, wherein the injectable material is a bone cement, a bone void filler, or a bone substitute material.

65. The kit of claim 64, wherein the injectable material further includes a bone growth stimulating factor.