Microfracture apparatuses and methods

• US 9,918,721 B2
• Filed: 12/05/2016
• Issued: 03/20/2018
• 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): GIBSON, ERIC SHANE
• Application Number:
  US15/369,350
• Publication Number:
  US 20170303934A1
• Time in Patent Office: 470 Days
• Field of Search: 606 79, 606 80, 606 84
• 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

Microfracture apparatuses with a cannula and a penetrator. The cannula has a first end, a second end, and a channel extending between the first end and the second end through which a penetrator can move between a retracted and an extended position substantially without rotation of the penetrator. The cannula has a primary portion and a distal portion between the primary portion and the second end, with the distal portion configured such that the distal portion and/or the second end of the channel is disposed at a nonparallel angle relative to the primary portion, for example, with a curve between the primary portion and the distal portion. The penetrator is configured to flex around such a curve and/or to flex to align with the angle of the send end of the channel and/or the distal portion of the cannula.

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 a non-parallel angle relative to a first end of the channel;

a monolithic penetrator having a proximal end, a distal end, 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;

an enlarged head coupled to the proximal end of the monolithic penetrator such that the enlarged head is configured to contact the cannula to limit the 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 a portion of the penetrator is configured to flex to permit the distal end of the penetrator to align with the angle of the second end of the channel in the cannula as the penetrator moves between the retracted and extended positions.

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 penetrator.

4. 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, and a curve between the primary portion and the distal portion such that the distal portion is disposed at a nonparallel angle relative to the primary portion;

a monolithic penetrator having a proximal end, a distal end, and 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;

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 a portion of the penetrator is configured to flex around the curve in the cannula as the penetrator moves between the retracted and extended positions.

5. The apparatus of claim 4, 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.

6. The apparatus of claim 4, where the first transverse dimension of the penetrator is less than 1.1 millimeters (mm).

7. The apparatus of claim 4, where the penetrator is configured to be manually moved from the retracted position to the extended position.

8. The apparatus of claim 4, further comprising:

an enlarged head coupled to the proximal end of the monolithic penetrator;

where the penetration distance is limited by the enlarged head contacting the cannula.

9. The apparatus of claim 8, where the penetrator comprises an elongated body and the enlarged head is coupled to the elongated body.

10. 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.

11. The apparatus of claim 4, where a coating is disposed on at least the penetration portion of the penetrator.

12. The apparatus of claim 11, where the coating is hydrophilic.

13. The apparatus of claim 4, where the penetrator includes a primary portion and a penetration portion, the primary portion having a circular cross-section, the penetration portion disposed between the primary portion and the distal end, the penetration portion having a circular cross-section that is smaller than the circular cross-section of the primary portion.

14. The apparatus of claim 13, where the first transverse dimension is in the penetration portion, and a second transverse dimension smaller than the first dimension is between the first transverse dimension and the primary portion.

15. The apparatus of claim 4, where the penetration portion includes a narrow portion with at least one transverse dimension that is smaller 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.

16. The apparatus of claim 4, where the distal end includes a pointed tip with a cross-sectional shape defined by a tip angle of 60 degrees or greater.

17. The apparatus of claim 16, where the tip angle is greater than 90 degrees.

18. The apparatus of claim 4, further comprising:

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

19. The apparatus of claim 18, where:

the cannula includes a handle,

the penetrator includes a flange,

the penetrator removal tab includes an elongated body with a first end, a second end, a length between the first and second ends, and a protrusion extending laterally outward from the body at a point between the opening and the second end; and

the penetrator removal tab is configured to be disposed between the handle and the flange with the penetrator extending through the opening, and the protrusion contacting a portion of the handle between the penetrator and the second end of the penetrator removal tab to act as a fulcrum for pivoting the penetrator removal tab relative to the handle.