Microfracture apparatuses and methods

• US 10,238,401 B2
• Filed: 09/09/2014
• Issued: 03/26/2019
• Est. Priority Date: 09/23/2013
• Status: Active Grant

• Current Assignee: Arthrosurface, Inc (Anika Therapeutics Incorporated)
• Original Assignee: Arthrosurface, Inc (Anika Therapeutics Incorporated)
• Inventors: Sikora, George J., Ek, Steven
• Primary Examiner(s): Yang, Andrew
• Application Number:
  US14/916,242
• Publication Number:
  US 20160192947A1
• Time in Patent Office: 1,659 Days
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1657 Bone breaking devices
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/00942 hydrophilic
• CPC Class Codes: A61B 2050/3008 having multiple compartments
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 50/33 Trays

Abstract

Embodiments of apparatuses and examplary methods for microfracture (e.g. forming a plurality of microfractures in a bone to encourage cartilage regeneration).

Claims

1. An apparatus comprising:

a cannula having a first end, a second end, and a channel extending between the first end and the second end, the channel having a first transverse dimension between the first end and the second end and having a second transverse dimension at the second end that is smaller than the first transverse dimension, where the first transverse dimension is disposed at a point that is closer to the second end than to the first end; and

a penetrator having a distal end and a first transverse dimension, the penetrator configured to be disposed in the channel of the cannula such that the penetrator is movable between a retracted position and an extended position in which the distal end extends beyond the second end of the cannula by a penetration distance;

where the penetrator is configured to be moved from the retracted position to the extended position substantially without rotation of the penetrator to form in subchondral bone a microfracture; and

where the channel has a third transverse dimension that is larger than the second transverse dimension, and the channel is tapered from the third transverse dimension to the second end.

2. The apparatus of claim 1, where a majority of the length of the channel has a substantially constant transverse dimension that is associated with the first transverse dimension.

3. The apparatus of claim 1, where the cannula has a primary portion and a distal portion between the primary portion and the second end, the distal portion configured such that:

a second end of the channel is disposed at an angle relative to a first end of the channel; and

the channel has a third transverse dimension at a proximal end of the distal portion that is larger than the second transverse dimension.

4. The apparatus of claim 3, where the third transverse dimension is substantially equal to the first transverse dimension of the channel.

5. The apparatus of claim 1, where the penetration distance is at least 5 times greater than the first transverse dimension of the channel.

6. The apparatus of claim 5, where the first transverse dimension is less than 1.2 millimeters (mm).

7. The apparatus of claim 1, where the penetrator is configured to be manually moved from the retracted position to the extended position, where the first end comprises an opening configured to receive the distal end of the penetrator, and where a transverse dimension of the opening is a maximum transverse dimension of the channel.

8. The apparatus of claim 1, where the penetrator has an enlarged head, and the penetration distance is limited by the enlarged head contacting the cannula.

9. The apparatus of claim 8, where the cannula includes a recessed portion and a shelf, the recessed portion extending from the first end of the cannula toward the second end of the cannula, the shelf disposed between the recessed portion and the second end of the cannula such that the penetration distance is limited by the enlarged head contacting the shelf.

10. The apparatus of claim 9, where the recessed portion has a depth that is at least as large as the penetration distance.

11. The apparatus of claim 9, where the enlarged head has a cylindrical shape with a length and a transverse dimension that is smaller than the length.

12. The apparatus of claim 1, where a coating is disposed on at least the penetration portion of the penetrator.

13. The apparatus of claim 1, where the penetration portion includes a narrow portion with at least one transverse dimension that is less than an adjacent transverse dimension of the penetration portion, such that the narrow portion is configured to reduce contact between the penetrator and a bone if the penetration portion is inserted into bone.

14. The apparatus of claim 1, where the distal end includes a pointed tip with a cross-sectional shape defined by a tip angle of 90 degrees or greater.

15. The apparatus of claim 1, further comprising:

a penetrator removal tab coupled to the penetrator and configured to retract the penetrator relative to the cannula.

16. The apparatus of claim 15, where:

the cannula includes a handle,

the penetrator includes a flange,

the penetrator removal tab includes an opening that is has at least one transverse dimension that is smaller than a transverse dimension of the flange; and

the penetrator removal tab is configured to be disposed between the handle and the flange with the penetrator extending through the opening.

17. The apparatus of claim 1, where the cannula comprises a handle having an indicator indicative of the position of the distal portion of the cannula.

18. The apparatus of claim 1, further comprising:

an adapter having a first end configured to be coupled to the first end of the cannula, and a second end configured to be coupled to a syringe such that the syringe can be actuated to deliver solution to the channel of the cannula.

19. The apparatus of claim 18, where the first end of the adapter includes a tapered outer surface.

20. The apparatus of claim 18, where the second end of the adapter includes a luer lock.

21. The apparatus of claim 18, where the adapter has two or more protrusions configured for manipulation of the adapter.

22. The apparatus of claim 1, further comprising:

an adapter having a first end configured to be coupled to the first end of the cannula, and a second end configured to be coupled to a syringe such that the syringe can be actuated to deliver solution to the channel of the cannula.

23. A kit comprising:

an apparatus of claim 1, where the penetrator is a first penetrator; and

a second penetrator configured to be disposed in the channel of the cannula such that the second penetrator is movable between a retracted position and an extended position.

24. A method of forming a microfracture in subchondral bone of a patient, the method comprising:

disposing the microfracture apparatus of claim 1 adjacent to the subchondral bone; and

advancing the penetrator relative to the cannula, substantially without rotation of the penetrator, until the distal end of the penetrator extends into the subchondral bone to form a microfracture having a depth greater than 5 mm.

25. The method of claim 24, further comprising:

repeating the steps of disposing and advancing to form a plurality of microfractures in the subchondral bone.

26. The method of claim 25, where the apparatus further comprises a penetrator removal tab coupled to the penetrator and configured to retract the penetrator relative to the cannula, the method further comprising:

actuating the penetrator removal tab to retract the distal end of the penetrator from the bone.

27. The method of claim 24, further comprising:

removing the penetrator from the cannula; and

injecting a solution to the microfracture through the channel of the cannula.

28. The method of claim 27, where the solution is injected into the channel through an adapter having a first end configured to be coupled to the first end of the cannula, and a second end configured to be coupled to a syringe such that the syringe can be actuated to deliver solution to the channel of the cannula.