Subchondral treatment of joint pain

• US 9,717,544 B2
• Filed: 02/09/2015
• Issued: 08/01/2017
• 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: Cohen, Steven B., Erbe, Erik M., Sharkey, Peter F., Leinberry, Charles F., Bagga, Charanpreet S.
• Primary Examiner(s): SEVILLA, CHRISTIAN ANTHONY
• Application Number:
  US14/617,058
• Publication Number:
  US 20150150616A1
• Time in Patent Office: 904 Days
• 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 system 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 injector tool, the instrument comprising a guide portion including a plurality of portals configured to guide the injector tool toward the subchondral region for treating the subchondral defect, the guide portion having a reference tip.

2. The system of claim 1, further comprising a cavity creation device for creating an access channel into the subchondral region of the bone.

3. The system of claim 2, wherein the cavity creation device is a drilling tool.

4. The system of claim 1, wherein the injectable material is a bone cement, a bone void filler, or a bone substitute material.

5. The system of claim 4, wherein the injectable material further includes a bone growth stimulating factor.

6. The system of claim 1, wherein the instrument further comprises a handle portion coupled to the guide portion.

7. The system of claim 6, wherein the handle portion includes one or more portals configured to guide the injector tool to the subchondral region of the bone.

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

9. The system of claim 1, wherein the reference tip is configured for placement on the bone without breaching an outer surface of the bone.

10. The system of claim 1, further comprising:

a K-wire configured for insertion into one of the portals in the guide portion of the instrument, the K-wire configured to form an access path to the subchondral region of the bone containing the subchondral defect; and

a cannulated boring device configured to form an enlarged access channel to the subchondral region of the bone containing the subchondral defect, the boring device sized to receive the K-wire such that the K-wire can guide the boring device toward the subchondral region of the bone.

11. The system of claim 1, wherein a proximal end of the guide portion, opposite the reference tip, includes a depth stop.

12. The system of claim 11, further comprising a K-wire configured for insertion into one of the portals in the guide portion of the instrument and including a depth stop, wherein contact between the depth stop of the guide portion and the depth stop of the K-wire can position a distal end of the K-wire at a desired depth within the subchondral region of the bone.

13. The system of claim 11, wherein the depth stop on the guide portion is adjustable.

14. The system of claim 1, wherein:

the portals of the guide portion include a portal axis configured to extend toward the subchondral defect in the subchondral region of the bone, the system further comprising a cavity creation device insertable into one of the portals and configured to create an access channel extending from an outer surface of the bone to the subchondral region of the bone, the injector tool configured for delivery of the material through the access channel for treatment of the subchondral defect.

15. The system of claim 14, wherein the injectable material is a bone cement, a bone void filler, or a bone substitute material.

16. The system of claim 15, wherein the injectable material further includes a bone growth stimulating factor.

17. The system of claim 14, wherein the subchondral defect is a bone marrow lesion or a bone marrow edema.

18. The system of claim 14, wherein the instrument includes at least one marker for identification under imaging.

19. A system 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, wherein the injectable material is a bone cement, a bone void filler, or a bone substitute material, and wherein the subchondral defect is a bone marrow lesion or a bone marrow edema;

an injector tool for delivery of the material; and

an instrument for guiding the injector tool, the instrument comprising a guide portion including a plurality of portals configured to guide the injector tool toward the subchondral region for treating the subchondral defect, the guide portion having a reference tip.

20. The system of claim 19, wherein the reference tip is configured for placement on the bone without breaching an outer surface of the bone.