Method for treating joint pain and associated instruments

• US 8,821,504 B2
• Filed: 11/19/2010
• Issued: 09/02/2014
• Est. Priority Date: 11/20/2009
• Status: Active Grant

• Current Assignee: Zimmer Knee Creations, Inc. (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Knee Creations, Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Sharkey, Peter F., Leinberry, Charles F., Cohen, Steven B., Bagga, Charanpreet S., Erbe, Erik M.
• Primary Examiner(s): Yang, Andrew
• Application Number:
  US12/950,097
• Publication Number:
  US 20110125156A1
• Time in Patent Office: 1,383 Days
• Field of Search: 606 92- 94, 606 96- 98
• US Class Current: 606/92
• CPC Class Codes: A61B 17/17 Guides or aligning means for drills , mills, pins or wires
• CPC Class Codes: A61B 17/1703 using imaging means, e.g. by X-rays
• 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 17/90 Guides therefor
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30 Joints
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2002/30001 Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof

Abstract

The embodiments provide provides devices, instruments, and associated methods for treating joint pain. A joint is evaluated using magnetic resonance imaging to detect any defects in the subchondral bone. For example, using T2-weighted MRI images, bone marrow lesions or edemas can be identified, and using T1-weighted MRI images, associated regions of sclerotic bone adjacent to the bone marrow lesion can be identified. The treatment method may involve introducing a bone void filler material at the site to address the bone marrow lesion or edema, and/or drilling and inserting an implant to address the sclerotic bone, bone marrow lesion or edema, and insufficiency or stress fractures. An access path is mapped to a location in the subchondral region where the insufficiency fracture resides. The access path attempts to preserve an articular surface of the joint. A reinforcing member that stabilizes the insufficiency fracture is then implanted via the access path.

Claims

1. A method for treating joint pain comprising:

identifying a source of the pain of the joint based on an image of the joint, the image indicating the presence of a defect in the subchondral region of a bone of the joint;

locating an insufficiency fracture in the subchondral region of the joint, wherein a subchondral defect is further present near the insufficiency fracture, the subchondral defect comprising a bone marrow lesion;

evaluating the bone marrow lesion based on a location of the bone marrow lesion and a size of the bone marrow lesion from the image of the joint;

mapping an access path to a location in the subchondral region where the insufficiency fracture resides, wherein the access path preserves an articular surface of the joint; and

implanting in the bone, via the access path, a reinforcing member that stabilizes the insufficiency fracture.

2. The method of claim 1, wherein implanting the reinforcing member comprises injecting a flowable material.

3. The method of claim 1, wherein the flowable material comprises a bone void filler, bone substitute material, or a bone cement.

4. The method of claim 1, wherein the flowable material stimulates bone growth.

5. The method of claim 4, wherein the flowable material includes calcium phosphate.

6. The method of claim 2, wherein the flowable material integrates the insufficiency fracture with surrounding bone tissue.

7. The method of claim 1, wherein the subchondral defect further includes sclerotic bone.

8. The method of claim 1, wherein the insufficiency fracture is a result of the subchondral defect.

9. The method of claim 1, wherein evaluating the bone marrow lesion comprises assessing the bone marrow lesion based on its proximity to a periphery of the bone.

10. The method of claim 1, wherein mapping the access path further includes creating access to the location of the bone marrow lesion.

11. The method of claim 10, wherein creating access comprises measuring a location of the bone marrow lesion based on a coordinate system that originates from an anatomic landmark on the bone.

12. The method of claim 1, wherein mapping the access further includes creating access by drilling.

13. The method of claim 11, wherein the coordinate system corresponds to predetermined settings of an instrument guide.

14. The method of claim 7, further including removing bone tissue and at least a portion of the sclerotic bone from the bone prior to implanting the reinforcing member.

15. The method of claim 1, wherein the reinforcing member is an implantable device.

16. The method of claim 15, wherein the implantable device is a bone plug.

17. The method of claim 1, wherein the access path comprises an inferior approach into the bone towards the insufficiency fracture.

18. The method of claim 17, wherein the inferior approach comprises an approach at an angle of about 30 to about 45 degrees.

19. The method of claim 1, further comprising resurfacing the articular surface of the joint.

20. The method of claim 19, further including removing the reinforcing member prior to resurfacing.

21. The method of claim 19, further including assessing an effectiveness of the reinforcing member prior to resurfacing.

22. The method of claim 1, wherein identifying the source of the pain of the joint based on an image of the joint comprises evaluating a magnetic resonance image of the joint.

23. The method of claim 7, wherein identifying the source of the pain of the joint comprises identifying the bone marrow lesion based on a T2-weighted magnetic resonance image joint and identifying the sclerotic bone based on a T1-weighted magnetic resonance image of the joint.

24. An instrument for guiding a tool to a target location in a bone adjacent to a joint, comprising:

a first portion having a first guide section including a plurality of portals, each portal being configured to guide the tool therethrough 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 the tool to the target location, the second guide section having a plurality of portals, each portal being configured to guide the tool therethrough at an acute angle with respect to the reference probe;

wherein the handle portion comprises an adjustable arm configured with a radius of curvature that provides an adjustable set of acute angles of approach to the target location.

25. The instrument of claim 24, wherein the tool is a drill, pin, implantable device delivery tool, guidewire, bone portal, rongeur, or hammer.

26. The instrument of claim 24, wherein the reference probe is configured to rest against an anatomical landmark on the bone adjacent to the joint.

27. The instrument of claim 24, wherein the openings are configured to guide the tool into a subchondral region of the bone.

28. The instrument of claim 24, wherein the instrument is a unitary body.

29. The instrument of claim 24, wherein the handle portion is configured to be detachable from the instrument.

40. The instrument of claim 24, wherein the first guide section is configured to guide the tool at an angle substantially parallel to the reference probe.

30. A method for treating joint pain comprising:

identifying a source of the pain of the joint based on an image of the joint, the image indicating the presence of a defect in the subchondral region of a bone of the joint;

locating an insufficiency fracture in the subchondral region of the joint, wherein a subchondral defect is further present near the insufficiency fracture, the subchondral defect comprising a bone marrow lesion;

evaluating the bone marrow lesion based on a location of the bone marrow lesion and a size of the bone marrow lesion from the image of the joint;

mapping an access path to a location in the subchondral region where the insufficiency fracture resides, wherein the access path preserves an articular surface of the joint; and

implanting in the bone, via the access path, a reinforcing member that stabilizes the insufficiency fracture;

wherein evaluating the bone marrow lesion comprises assessing the bone marrow lesion based on its proximity to a periphery of the bone.

31. A method for treating joint pain comprising:

identifying a source of the pain of the joint based on an image of the joint, the image indicating the presence of a defect in the subchondral region of a bone of the joint;

locating an insufficiency fracture in the subchondral region of the joint, wherein a subchondral defect is further present near the insufficiency fracture, the subchondral defect comprising a bone marrow lesion;

mapping an access path to a location in the subchondral region where the insufficiency fracture resides, wherein the access path preserves an articular surface of the joint; and

implanting in the bone, via the access path, a reinforcing member that stabilizes the insufficiency fracture;

wherein mapping the access path further includes creating access to the location of the bone marrow lesion.

32. A method for treating joint pain comprising:

identifying a source of the pain of the joint based on an image of the joint, the image indicating the presence of a defect in the subchondral region of a bone of the joint;

locating an insufficiency fracture in the subchondral region of the joint, wherein a subchondral defect is further present near the insufficiency fracture, the subchondral defect comprising a bone marrow lesion;

mapping an access path to a location in the subchondral region where the insufficiency fracture resides, wherein the access path preserves an articular surface of the joint; and

implanting in the bone, via the access path, a reinforcing member that stabilizes the insufficiency fracture;

wherein mapping the access path further includes creating access to the location of the bone marrow lesion; and

further wherein creating access comprises measuring a location of the bone marrow lesion based on a coordinate system that originates from an anatomic landmark on the bone.

33. A method for treating joint pain comprising:

identifying a source of the pain of the joint based on an image of the joint, the image indicating the presence of a defect in the subchondral region of a bone of the joint;

locating an insufficiency fracture in the subchondral region of the joint, wherein a subchondral defect is further present near the insufficiency fracture, the subchondral defect comprising a bone marrow lesion;

mapping an access path to a location in the subchondral region where the insufficiency fracture resides, wherein the access path preserves an articular surface of the joint; and

implanting in the bone, via the access path, a reinforcing member that stabilizes the insufficiency fracture;

wherein mapping the access path further includes creating access to the location of the bone marrow lesion; and

further wherein creating access comprises measuring a location of the bone marrow lesion based on a coordinate system that originates from an anatomic landmark on the bone, the coordinate system corresponding to predetermined settings of an instrument guide.

34. A method for treating joint pain comprising:

identifying a source of the pain of the joint based on an image of the joint, the image indicating the presence of a defect in the subchondral region of a bone of the joint;

locating an insufficiency fracture in the subchondral region of the joint, wherein the subchondral defect further includes sclerotic bone;

mapping an access path to a location in the subchondral region where the insufficiency fracture resides, wherein the access path preserves an articular surface of the joint;

implanting in the bone, via the access path, a reinforcing member that stabilizes the insufficiency fracture; and

further including removing bone tissue and at least a portion of the sclerotic bone from the bone prior to implanting the reinforcing member.

35. A method for treating joint pain comprising:

identifying a source of the pain of the joint based on an image of the joint, the image indicating the presence of a defect in the subchondral region of a bone of the joint;

locating an insufficiency fracture in the subchondral region of the joint;

mapping an access path to a location in the subchondral region where the insufficiency fracture resides, wherein the access path preserves an articular surface of the joint;

implanting in the bone, via the access path, a reinforcing member that stabilizes the insufficiency fracture; and

further comprising resurfacing the articular surface of the joint.

36. A method for treating joint pain comprising:

identifying a source of the pain of the joint based on an image of the joint, the image indicating the presence of a defect in the subchondral region of a bone of the joint;

locating an insufficiency fracture in the subchondral region of the joint;

mapping an access path to a location in the subchondral region where the insufficiency fracture resides, wherein the access path preserves an articular surface of the joint;

implanting in the bone, via the access path, a reinforcing member that stabilizes the insufficiency fracture; and

further comprising resurfacing the articular surface of the joint, wherein the reinforcing member is removed prior to resurfacing.

37. A method for treating joint pain comprising:

identifying a source of the pain of the joint based on an image of the joint, the image indicating the presence of a defect in the subchondral region of a bone of the joint;

locating an insufficiency fracture in the subchondral region of the joint;

mapping an access path to a location in the subchondral region where the insufficiency fracture resides, wherein the access path preserves an articular surface of the joint;

implanting in the bone, via the access path, a reinforcing member that stabilizes the insufficiency fracture;

assessing an effectiveness of the reinforcing member; and

resurfacing the articular surface of the joint.

38. A method for treating joint pain comprising:

identifying a source of the pain of the joint based on an image of the joint, the image indicating the presence of a defect in the subchondral region of a bone of the joint;

locating an insufficiency fracture in the subchondral region of the joint, wherein a subchondral defect is further present near the insufficiency fracture, the subchondral defect including sclerotic bone;

mapping an access path to a location in the subchondral region where the insufficiency fracture resides, wherein the access path preserves an articular surface of the joint; and

implanting in the bone, via the access path, a reinforcing member that stabilizes the insufficiency fracture;

wherein identifying the source of the pain of the joint comprises identifying the bone marrow lesion based on a T2-weighted magnetic resonance image joint and identifying the sclerotic bone based on a T1-weighted magnetic resonance image of the joint.

39. An instrument for guiding a tool to a target location in a bone adjacent to a joint, comprising:

a first portion having a first guide section including a plurality of portals, each portal being configured to guide the tool therethrough 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 the tool to the target location, the second guide section having a plurality of portals, each portal being configured to guide the tool therethrough at an acute angle with respect to the reference probe;

wherein the handle portion comprises an adjustable arm that provides an adjustable set of angles of approach to the target location.

41. The instrument of claim 39, wherein the first guide section is configured to guide the tool at an angle substantially parallel to the reference probe.