Microfracture apparatuses and methods

• US 9,211,126 B2
• Filed: 03/07/2013
• Issued: 12/15/2015
• Est. Priority Date: 03/09/2012
• Status: Active Grant

• Current Assignee: Arthrosurface, Inc (Anika Therapeutics Incorporated)
• Original Assignee: Arthrosurface, Inc (Anika Therapeutics Incorporated)
• Inventors: Sikora, George J., Ek, Steven, Tallarida, Steven
• Primary Examiner(s): Sevilla, Christian
• Assistant Examiner(s): GIBSON, ERIC SHANE
• Application Number:
  US13/788,713
• Publication Number:
  US 20130317506A1
• Time in Patent Office: 1,013 Days
• Field of Search: 606/79, 606/80, 606/84
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1675 for the knee
• CPC Class Codes: A61B 17/17 Guides or aligning means for drills , mills, pins or wires
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: F04C 2270/041 Controlled or regulated

Abstract

Embodiments of apparatuses and 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 cannula having 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;

a penetrator having an enlarged head and a monolithic wire extending from the enlarged head to a pointed distal end, a first transverse dimension of less than 1.2 millimeters (mm), and a second transverse dimension that is larger than the first transverse dimension, the penetrator including a primary portion extending from the enlarged head toward the distal end, and a penetration portion extending from the primary portion to the distal end, where the first transverse dimension is in the penetration portion and the second transverse dimension is in the primary portion, 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 of at least 5 mm that is limited by the enlarged head contacting the cannula;

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 having a depth of at least 5 mm.

2. The apparatus of claim 1, where the distal portion of the cannula is angled relative to the primary portion of the cannula.

3. The apparatus of claim 1, where the enlarged head is unitary with the wire.

4. The apparatus of claim 1, where a third transverse dimension is disposed at a point between the first transverse dimension and the primary portion;

and the third transverse dimension is smaller than the first transverse dimension.

5. The apparatus of claim 4, where the penetration portion has a length, and the third transverse dimension is substantially constant along part of the length of the penetration portion.

6. The apparatus of claim 5, where the first transverse dimension is closer to the distal end than to the primary portion.

7. The apparatus of claim 1, where the cannula includes a handle, and the apparatus further comprises:

a penetrator removal tab including an opening with at least one transverse dimension that is smaller than a transverse dimension of the enlarged head of the penetrator, the penetrator removal tab configured to be disposed between the handle and the enlarged head with the penetrator extending through the opening and into the channel of the cannula such that a portion of the penetrator removal tab can be pressed toward the second end of the cannula to retract the penetrator relative to the cannula.

8. The apparatus of claim 7, where the enlarged head includes a flange, and the at least one transverse dimension of the opening in the penetrator removal tab is smaller than a transverse dimension of the flange.

9. The apparatus of claim 1, where a portion of the penetrator that extends beyond the second end of the cannula in the extended position has a substantially constant cross-section along a majority of its length.

10. An apparatus comprising:

a cannula having a first end, a second end, and a channel extending between the first end and the second end;

a penetrator including a primary portion extending from a proximal end toward a distal end, a penetration portion comprising a monolithic wire extending from the primary portion to the distal end, where a first transverse dimension is in the penetration portion and a second transverse dimension is in the primary portion and the first transverse dimension is less than 1.2 millimeters (mm), 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 of at least 5 mm;

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 having a depth of at least 5 mm;

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; and

where the enlarged head has a cylindrical shape with a longitudinal length and a transverse dimension that is smaller than the length.

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

12. The apparatus of claim 10, where the enlarged head has a transverse dimension that is at least 90% of a corresponding transverse dimension of the recessed portion.

13. An apparatus comprising:

a cannula having a first end, a second end, and a channel extending between the first end and the second end;

a penetrator having a primary portion and a penetration portion comprising a monolithic wire extending from the primary portion to a distal end, the penetration portion having a first transverse dimension of less than 1.2 millimeters (mm) and the primary portion having a second transverse dimension that is larger than the 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 of at least 5 mm;

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 having a depth of at least 5 mm;

where a coating is disposed on at least the penetration portion of the penetrator; and

where the coating is hydrophilic.

14. The apparatus of claim 13, where the coating comprises silver ions.

15. An apparatus comprising:

a cannula having a first end, a second end, and a channel extending between the first end and the second end;

a penetrator having a primary portion and a penetration portion comprising a monolithic wire extending from the primary portion to a distal end, the penetration portion having a first transverse dimension of less than 1.2 millimeters (mm), 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 of at least 5 mm;

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 having a depth of at least 5 mm;

where the penetration portion is disposed between the primary portion and the distal end and a second transverse dimension is between the first transverse dimension and the primary portion; and

where the second transverse dimension is smaller than the first transverse dimension.

16. The apparatus of claim 15, where the penetration portion has a length, and the second transverse dimension is substantially constant along part of the length of the penetration portion.

17. The apparatus of claim 16, where the first transverse dimension is closer to the distal end than to the primary portion.

18. The apparatus of claim 17, where the penetrator has a first cross-sectional area at the first transverse dimension, the penetrator has a second cross-sectional area at the second transverse dimension, and the first cross-sectional area is larger than the second cross-sectional area.

19. The apparatus of claim 18, where the penetrator has a first circular cross section at the first transverse dimension, and the penetrator has a second circular cross section at the second transverse dimension.

20. An apparatus comprising:

a cannula having a first end, a second end, and a channel extending between the first end and the second end;

a penetrator having a primary portion and a penetration portion comprising a monolithic wire extending from the primary portion to a distal end, the penetration portion having a first transverse dimension of less than 1.2 millimeters (mm) and the primary portion having a second transverse dimension that is larger than the 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 of at least 5 mm;

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

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 having a depth of at least 5 mm;

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.

21. The apparatus of claim 20, where the penetrator removal tab includes a protrusion configured to extend toward the second end of the cannula and contact the handle to act as a fulcrum for pivoting the penetrator removal tab.

22. The apparatus of claim 20, where the penetrator removal tab includes a protrusion configured to extend toward the second end of the cannula and contact the handle to act as a fulcrum for pivoting the penetrator removal tab.