Soft tissue repair device and method

• US 9,504,460 B2
• Filed: 10/05/2012
• Issued: 11/29/2016
• Est. Priority Date: 11/05/2004
• Status: Active Grant

• Current Assignee: Biomet Sports Medicine LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Sports Medicine LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Stone, Kevin T., Sautter, Nathan M., Berelsman, Brian K., Arnett, Jeffery D., Butters, Joshua A., Hushka, Dylan M., Slater, Nicholas R.
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US13/645,964
• Publication Number:
  US 20130035698A1
• Time in Patent Office: 1,516 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/042 plastically deformed during insertion
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/2923 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument

Abstract

A soft tissue repair device can include a housing having a handle, a deployment system having an actuation member, and an insertion system having an inserter and a slider. The slider can be coupled to the actuation member and movable relative to the inserter between deployed and retracted positions. First and second anchors can be carried on an external surface of the slider such that the anchors are spaced apart and portions of the anchors are coaxial with the slider and each other. A flexible strand can couple the anchors. The insertion system can cooperate with the deployment system to move the slider to the deployed position to deploy the first anchor upon activating the actuation member a first time, and to move the slider to the deployed position from the retracted position to deploy the second anchor upon actuating the actuation member a second time after the first time.

Claims

1. A method for repairing a tear in soft tissue, comprising:

providing or obtaining first and second flexible anchors coupled to one another with a flexible strand;

providing or obtaining an insertion device having a housing with a pistol grip handle, an inserter and a slider carried in the inserter, wherein the inserter and the slider each have a distal end extending from the housing, wherein the first and second coupled anchors are loaded on an external surface of the slider with the slider extending through a portion of each of the first and second coupled anchors;

inserting, with the first and second coupled anchors situated in the inserter, the distal end of the inserter through the soft tissue from a first side of the tear through a second side of the tear and through an exterior surface of the soft tissue to a first location along the exterior surface of the soft tissue;

actuating an actuation member protruding from the pistol grip handle at a first time to translate the distal end of the slider beyond the distal end of the inserter;

deploying the first anchor from the slider to deliver the first anchor to the first location along the exterior surface of the soft tissue;

releasing the actuation member after deploying the first anchor;

removing the inserter from the soft tissue;

inserting the inserter through the soft tissue for a second time and to a second location along the exterior surface of the soft tissue;

actuating the actuation member a second time after the first time to extend the distal end of the slider beyond the distal end of the inserter;

deploying the second anchor from the slider to deliver the second anchor to the second location along the exterior surface of the soft tissue;

removing the inserter from the soft tissue for a second time; and

tensioning the flexible strand.

2. The method of claim 1, wherein the flexible strand comprises an adjustable knotless loop passing through a portion of each flexible anchor;

and

wherein an internal longitudinal bore of each of the first and second flexible anchors is positioned over the external surface of the slider such that at least a portion of the first and second anchors are coaxial with the slider and each other.

3. The method of claim 2, wherein the adjustable knotless loop includes a first end of the flexible strand passing through a longitudinal passage defined by a portion of the flexible strand.

4. The method of claim 2, wherein the first and second anchors are positioned on the slider such that the first anchor is on a distal side of an engagement portion of the slider, and the second anchor is on a proximal side of the engagement portion.

5. The method of claim 2, wherein tensioning the flexible strand comprises self-locking the adjustable knotless loop.

6. The method of claim 5, wherein the first and second flexible anchors are loaded in a substantially linear first shape on an external surface of the slider;

and

wherein tensioning the flexible strand comprises changing the shape of each flexible anchor from the first shape to a second deformed shape that is suitable for securing each flexible anchor to the external surface of the soft tissue.

7. The method of claim 2, wherein the first and second coupled anchors are loaded on the external surface of the slider with only a portion of the internal bores of the first and second coupled anchors positioned over the external surface of the slider such that a first portion of each anchor is coaxial with the slider and a second tail portion of each anchor extends at an angle relative to the slider, and

wherein the second tail portion is configured to engage the external surface of the soft tissue when the actuation member is released and the slider is retracted from being translated beyond the distal end of the inserter.

8. The method of claim 1, wherein providing or obtaining an insertion device further includes providing or obtaining an insertion device with an outer cannula having a distal end extending from the housing and a proximal end coupled to an adjustment mechanism, the slider and the inserter being positioned in a longitudinal passage extending through the outer cannula.

9. The method of claim 8, further comprising adjusting a distal end of the outer cannula relative to the distal end of the inserter such that the distal end of the inserter extends beyond the distal end of the outer cannula so as to establish an insertion depth of the inserter.

10. The method of claim 1, wherein actuating an actuation member at a first time comprises translating a positioning member disposed coaxially around the slider and inside the inserter to translate the second anchor forward towards the distal end of the inserter.

11. The method of claim 10, wherein releasing the actuation member comprises retracting the slider to a retracted position such that an engagement portion of the slider is positioned adjacent to or beyond the translated second anchor;

and

wherein actuating the actuation member a second time includes depressing the actuation member a second time after releasing the actuation member and translating the second anchor to the third position such that the engagement portion of the slider engages the second anchor and moves the second anchor beyond the distal end of the inserter.

12. The method of claim 1, wherein the first and second coupled anchors are longitudinally spaced from one another along the slider when deploying the first anchor from the slider.

13. A method for repairing a tear in soft tissue, comprising:

adjusting a position of a distal end of an outer cannula relative to a distal end of an inserter;

inserting the distal end of the inserter into soft tissue and through the soft tissue to a first location along an exterior surface of the soft tissue, wherein during said inserting a first anchor and a slider carrying the first anchor are situated in the inserter;

actuating an actuation member at a first time to translate a distal end of the slider beyond the distal end of the inserter, wherein, during said actuating, the slider is extending through a portion of the first anchor such that advancement of the slider through the inserter advances the first anchor through the inserter;

deploying the first anchor from the slider to deliver the first anchor to the first location along the exterior surface of the soft tissue; and

removing the inserter from the soft tissue.

14. The method of claim 13, further comprising:

releasing the actuation member after deploying the first anchor;

retracting the slider to a retracted position such that an engagement portion of the slider is positioned adjacent to a translated second anchor;

inserting the distal end of the inserter into the soft tissue for a second time and through the soft tissue to a second location along the exterior surface of the soft tissue; and

actuating the actuation member at a second time to deploy the second anchor upon the engagement portion of the slider engaging the second anchor and moving the second anchor beyond the distal end of the inserter to deliver the second anchor to the second location along the exterior surface of the soft tissue.

15. The method of claim 14, further comprising tensioning a flexible strand coupled to the first and second anchors to close the tear in the soft tissue.

16. The method of claim 14, wherein actuating the actuation member at a first time includes translating a positioning member disposed coaxially around the slider and inside the inserter to translate the second anchor forward toward the distal end of the inserter.

17. The method of claim 13, wherein only a portion of an internal bore of the first anchor is positioned over an external surface of the slider such that a first portion of the first anchor is coaxial with the slider and a second tail portion extends at an angle relative to the slider.

18. The method of claim 13, wherein said deploying the first anchor from the slider includes having the entire first anchor positioned along the exterior surface of the soft tissue.

19. The method of claim 13, wherein the first anchor has a leading end and a trailing end during said carrying, and wherein said deploying the first anchor from the slider includes the leading end and the trailing end passing through the soft tissue to the first location along the exterior surface of the soft tissue.

20. A method for repairing a tear in soft tissue, comprising:

inserting a distal end of an inserter into the soft tissue and through the soft tissue to a first location along an exterior surface of the soft tissue, wherein a first anchor and a second anchor and a slider carrying the first anchor and the second anchor are situated in the inserter during inserting the distal end of the inserter into the soft tissue and through the soft tissue to the first location along an exterior surface of the soft tissue, the slider extending through a portion of each of the first anchor and the second anchor;

actuating an actuation member of a pistol grip handle at a first time to translate a distal end of the slider beyond the distal end of the inserter;

deploying the first anchor from the slider to deliver the first anchor to the first location along the exterior surface of the soft tissue;

releasing the actuation member after deploying the first anchor;

removing the inserter from the soft tissue;

inserting the distal end of the inserter into the soft tissue and through the soft tissue to a second location along the exterior surface of the soft tissue;

actuating the actuation member at a second time to extend the distal end of the slider beyond the distal end of the inserter;

deploying the second anchor from the slider to deliver the second anchor to the second location along the exterior surface of the soft tissue; and

removing the inserter from the soft tissue for a second time.

21. The method of claim 20, further comprising:

tensioning a flexible strand coupled to the first anchor and the second anchor; and

changing a configuration of the first anchor and the second anchor from a first configuration to a second configuration upon tensioning.

22. The method of claim 20, wherein actuating an actuation member at a first time further includes translating a positioning member disposed coaxially around the slider and inside the inserter to translate the second anchor forward towards the distal end of the inserter.

23. The method of claim 20, wherein releasing the actuation member further includes retracting the slider to a retracted position such that an engagement portion of the slider is positioned adjacent to or beyond the translated second anchor;

and

wherein actuating the actuation member at a second time includes depressing the actuation member a second time after releasing the actuation member and translating the second anchor such that the engagement portion of the slider engages the second anchor and moves the second anchor beyond the distal end of the inserter.