Method for treating joint pain and associated instruments

• US 9,119,721 B2
• Filed: 08/07/2014
• Issued: 09/01/2015
• 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:
  US14/454,298
• Publication Number:
  US 20140350683A1
• Time in Patent Office: 390 Days
• US Class Current: 1/1
• 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 of subchondrally accessing an area in or adjacent to a bone marrow lesion in a subchondral region of a proximal tibia, the method comprising:

identifying a bone marrow lesion in a subchondral region of a proximal tibia, the subchondral region occurring under an articular surface of the proximal tibia;

providing a guide instrument positioned adjacent the proximal tibia with a tip of a probe of the guide instrument contacting a location on the articular surface of the proximal tibia and with a first opening in the guide instrument being in receipt of an access tool that is advanceable through the first opening for entry into the proximal tibia, wherein the tip of the probe contacting said location establishes a targeted delivery site in the subchondral region of the proximal tibia, the targeted delivery site spaced a distance from the tip of the probe and located in an area of the subchondral region in or adjacent to the bone marrow lesion; and

advancing the access tool through the first opening and into the proximal tibia, wherein the first opening guides the access tool to the targeted delivery site in a first direction and in a manner that preserves an existing condition of the articular surface of the proximal tibia.

2. The method of claim 1, further comprising injecting an injectable material into the targeted delivery site, wherein the injectable fluid material is left in the targeted delivery site for becoming less fluid in the targeted delivery site for reinforcing bone located in the bone marrow lesion.

3. The method of claim 1, wherein the targeted delivery site is within 5 mm from the tip of the probe.

4. The method of claim 1, wherein said first direction is parallel to the articular surface of the proximal tibia.

5. The method of claim 1, wherein said first direction is parallel to a direction of travel of the reference probe.

6. The method of claim 1, wherein the guide instrument includes a second opening therein for guiding said access tool or a second access tool to the targeted delivery site in a second direction and in a manner that preserves the existing condition of the articular surface of the proximal tibia, said second direction angled acutely relative to said first direction.

7. The method of claim 6 further comprising advancing the access tool or the second access tool in said second direction through the second opening to the targeted delivery site in a manner that preserves the existing condition of the articular surface of the proximal tibia.

8. An instrument for guiding one or more tools to a subchondral region of a proximal tibia, the proximal tibia having an articular surface, the instrument comprising:

an upper instrument portion that incorporates a first guide section, the first guide section including a first opening that extends through the upper instrument portion for allowing passage of a first access tool through the upper instrument portion for guiding the first access tool, in a first direction and in a manner that preserves an existing condition of the articular surface of the proximal tibia, to an area in or adjacent to a bone marrow lesion in a subchondral region of a proximal tibia;

a reference probe that extends from the upper instrument portion and which includes a leading tip positionable on the articular surface of the proximal tibia; and

a lower instrument portion that incorporates a second guide section, the second guide section including a second opening that extends through the lower instrument portion for allowing passage of a second access tool through the lower instrument portion for guiding the second access tool, in a second direction and in a manner that preserves an existing condition of the articular surface of the proximal tibia, to the area in or adjacent to the bone marrow lesion in the subchondral region of the proximal tibia, wherein said second direction is angled acutely relative to said first direction.

9. The instrument of claim 8, wherein the reference probe, the upper instrument portion, and the lower instrument portion are part of a unitarily-formed instrument piece.

10. The instrument of claim 8 in combination with a first access tool received in said first opening.

11. The instrument of claim 8, wherein said reference probe is straight.

12. The instrument of claim 8, wherein said first guide section includes a plurality of first openings that each extend through the upper instrument portion.

13. The instrument of claim 8, wherein the reference probe includes a base portion that adjoins the upper instrument portion, and wherein a reference line drawn between said base portion and the leading tip of the reference probe is substantially parallel to said first direction.

14. The instrument of claim 8, wherein the first access tool and the second access tool are the same tool.

15. A method of subchondrally accessing a targeted delivery site in a subchondral region of a proximal tibia, the method comprising:

identifying a cartilage defect on an articular surface of the proximal tibia;

providing a guide instrument positioned adjacent the proximal tibia with a tip of a probe of the guide instrument contacting the cartilage defect and with a first opening in the guide instrument being in receipt of an access tool that is advanceable through the first opening for entry into the proximal tibia, wherein the tip of the probe contacting the cartilage defect establishes a targeted delivery site in a subchondral region of the proximal tibia, the targeted delivery site spaced a distance from the tip of the probe; and

advancing the access tool through the first opening and into the proximal tibia, wherein the first opening guides the access tool to the targeted delivery site in a first direction and in a manner that preserves an existing condition of the articular surface of the proximal tibia.

16. The method of claim 15, further comprising injecting an injectable material into the targeted delivery site, wherein the injectable fluid material is left in the targeted delivery site for becoming less fluid in the targeted delivery site for reinforcing bone in the subchondral region of the proximal tibia.

17. The method of claim 15, wherein the targeted delivery site is within 5 mm from the tip of the probe.

18. The method of claim 15, wherein said first direction is parallel to the articular surface of the proximal tibia.

19. The method of claim 15, wherein said first direction is parallel to a direction of travel of the reference probe.

20. The method of claim 15, wherein the guide instrument includes a second opening therein for guiding said access tool or a second access tool to the targeted delivery site in a second direction and in a manner that preserves the existing condition of the articular surface of the proximal tibia, said second direction angled acutely relative to said first direction.

21. The method of claim 16 further comprising advancing the access tool or the second access tool in said second direction through the second opening to the targeted delivery site in a manner that preserves the existing condition of the articular surface of the proximal tibia.