Method and apparatus for attaching tissue to bone, including the provision and use of a novel knotless suture anchor system, including a retractable sheath

• US 10,136,884 B2
• Filed: 10/13/2015
• Issued: 11/27/2018
• Est. Priority Date: 07/17/2009
• Status: Active Grant

• Current Assignee: Stryker Puerto Rico Holdings BV (Stryker Corporation)
• Original Assignee: Pivot Medical, Inc. (Stryker Corporation)
• Inventors: Graul, Jeremy, Burley, J. Brook
• Primary Examiner(s): LYNCH, ROBERT A
• Application Number:
  US14/881,259
• Publication Number:
  US 20160030034A1
• Time in Patent Office: 1,141 Days
• 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 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 2017/0403 Dowels other bone dowels A61B17/68; dowels for connecting prosthetic parts A61F2002/30433
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• 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 2017/0424 the separate member staying in the anchor after placement
• CPC Class Codes: A61B 2017/0448 Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/0451 Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0453 threaded elements, e.g. set screws
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot

Abstract

Apparatus for securing a suture to a bone, the apparatus including an anchor configured to have the suture connected thereto; and an inserter for manipulating the anchor, the inserter including a handle; a shaft mounted to the handle and configured to releasably hold the anchor thereto; a retractable sheath movably mounted to the handle, the retractable sheath having a first extended position and a second retracted position, wherein the retractable sheath is disposed coaxially over at least a portion of the anchor when the retractable sheath is in its first extended position, and the retractable sheath is withdrawn from the anchor when the retractable sheath is in its second retracted position; and an outer tube mounted to the handle, the outer tube being disposed coaxially over the retractable sheath.

Claims

1. Apparatus for securing a first object to a second object, the apparatus comprising:

an anchor, the anchor comprising;

an elongated body having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end, the lumen comprising a distal section and a proximal section, the distal section of the lumen having a wider diameter than the proximal section of the lumen;

a window extending through the side wall of the elongated body and communicating with the lumen, the window being disposed in the vicinity of an intersection between the distal section of the lumen and the proximal section of the lumen and being sized to receive a first object therein;

an elongated element extending through the lumen of the elongated body, the elongated element comprising a proximal end and a distal end; and

a locking element mounted to the distal end of the elongated element and disposed in the distal section of the lumen;

whereby, when the elongated body is disposed in a second object, and a first object extends through the window, and the locking element is thereafter moved proximally, proximal movement of the locking element causes the elongated body to capture the first object to the elongated body, whereby to secure the first object to the second object; and

an inserter, the inserter comprising;

a handle;

a shaft having a distal end and a proximal end, with a lumen extending therebetween, the proximal end of the shaft being mounted to the handle and the distal end of the shaft being configured to releasably engage the elongated body;

a retractable sheath disposed movably coaxially about the shaft; and

a movable tab mounted to the proximal end of the retractable sheath for moving the retractable sheath relative to the shaft.

2. Apparatus according to claim 1 wherein the retractable sheath is movable between a first extended position and a second retracted position, and further wherein the retractable sheath is disposed coaxially over at least a portion of the elongated body when the retractable sheath is in its first extended position, and the retractable sheath is withdrawn from the elongated body when the retractable sheath is in its second retracted position.

3. Apparatus according to claim 2 wherein the retractable sheath is spring-biased into its first extended position.

4. Apparatus according to claim 2 wherein the distal end of the elongated body protrudes from the retractable sheath when the retractable sheath is in its first extended position.

5. Apparatus according to claim 4 further comprising an overtube mounted to the handle and extending distally therefrom, the overtube being mounted coaxially about the retractable sheath and terminating proximal to the distal end of the retractable sheath when the retractable sheath is in its first extended position.

6. Apparatus according to claim 5 wherein the handle comprises an opening, and the movable tab is slidably disposed in the opening, such that by moving the movable tab proximally within the opening, the retractable sheath is retracted proximally, and such that by moving the movable tab distally within the opening, the retractable sheath is advanced distally.

7. Apparatus according to claim 6 wherein the opening comprises a T-shaped slot.

8. Apparatus according to claim 7 wherein the T-shaped slot comprises a longitudinally-extending section which extends parallel to the longitudinal axis of the shaft, and a laterally-extending section which extends at an oblique angle to the longitudinal axis of the shaft.

9. Apparatus according to claim 8 wherein the retractable sheath is movable relative to the shaft when the movable tab is disposed in the longitudinally-extending section of T-shaped slot and wherein the retractable sheath is not movable relative to the shaft when the movable tab is disposed in the laterally-extending section of T-shaped slot.

10. Apparatus according to claim 6 wherein the opening comprises an L-shaped slot.

11. Apparatus according to claim 6 wherein the handle further comprises a releasable locking mechanism, the releasable locking mechanism being configured to selectively lock the movable tab in a desired position within the opening.

12. Apparatus according to claim 11 wherein the releasable locking mechanism comprises at least one from the group consisting of a detent, a snap and a recess.

13. Apparatus according to claim 6 wherein the handle further comprises markings along the opening for indicating the position of the retractable sheath relative to the position of the movable tab.

14. Apparatus for securing a suture to a bone, the apparatus comprising:

an anchor configured to have the suture connected thereto; and

an inserter for manipulating the anchor, the inserter comprising;

a handle;

a shaft mounted to the handle and configured to releasably hold the anchor thereto;

a retractable sheath movably mounted to the handle, the retractable sheath having a first extended position and a second retracted position, wherein the retractable sheath is disposed coaxially over at least a portion of the anchor when the retractable sheath is in its first extended position, and the retractable sheath is withdrawn from the anchor when the retractable sheath is in its second retracted position; and

an outer tube fixedly mounted to the handle, the outer tube being disposed coaxially over the retractable sheath.

15. Apparatus according to claim 14 wherein the retractable sheath is spring-biased into its first extended position.

16. A method for securing a first object to a second object, the method comprising:

providing apparatus comprising;

an anchor, the anchor comprising;

an elongated body having a distal end, a proximal end, and a lumen extending between the distal end and the proximal end, the lumen comprising a distal section and a proximal section, the distal section of the lumen having a wider diameter than the proximal section of the lumen;

a window extending through the side wall of the elongated body and communicating with the lumen, the window being disposed in the vicinity of an intersection between the distal section of the lumen and the proximal section of the lumen and being sized to receive a first object therein;

an elongated element extending through the lumen of the elongated body, the elongated element comprising a proximal end and a distal end; and

a locking element mounted to the distal end of the elongated element and disposed in the distal section of the lumen; and

an inserter, the inserter comprising;

a handle;

a shaft having a distal end and a proximal end, with a lumen extending therebetween, the proximal end of the shaft being mounted to the handle and the distal end of the shaft being configured to releasably engage the elongated body;

a retractable sheath disposed movably coaxially about the shaft; and

a movable tab mounted to the proximal end of the retractable sheath for moving the retractable sheath relative to the shaft;

extending the first object through the window of the elongated body;

using the inserter to position the elongated body in the second object; and

moving the locking element proximally, such that proximal movement of the locking element causes the elongated body to capture the first object to the elongated body, whereby to secure the first object to the second object.

17. A method according to claim 16 wherein the retractable sheath covers a majority of the anchor as the anchor is advanced to the second object, and further wherein the retractable sheath is withdrawn proximally before the elongated body is seated in the second object.

18. A method according to claim 17 wherein the movable tab is used to withdraw the retractable sheath proximally before the elongated body is seated in the second object.

19. A method according to claim 17 wherein engagement of the retractable sheath with the second object causes the retractable sheath to be withdrawn proximally before the elongated body is seated in the second object.

20. A method according to claim 16 wherein the handle comprises an opening, and the movable tab is slidably disposed in the opening, such that by moving the movable tab proximally within the opening, the retractable sheath is retracted proximally, and such that by moving the movable tab distally within the opening, the retractable sheath is advanced distally.

21. A method according to claim 20 wherein the opening comprises a T-shaped slot.

22. A method according to claim 21 wherein the T-shaped slot comprises a longitudinally-extending section which extends parallel to the longitudinal axis of the shaft, and a laterally-extending section which extends at an oblique angle to the longitudinal axis of the shaft.

23. A method according to claim 22 wherein the retractable sheath is movable relative to the shaft when the movable tab is disposed in the longitudinally-extending section of T-shaped slot and wherein the retractable sheath is not movable relative to the shaft when the movable tab is disposed in the laterally-extending section of T-shaped slot.

24. A method for securing a suture to a bone, the method comprising:

providing apparatus comprising;

an anchor configured to have the suture connected thereto; and

an inserter for manipulating the anchor, the inserter comprising;

a handle;

a shaft mounted to the handle and configured to releasably hold the anchor thereto;

a retractable sheath movably mounted to the handle, the retractable sheath having a first extended position and a second retracted position, wherein the retractable sheath is disposed coaxially over at least a portion of the anchor when the retractable sheath is in its first extended position, and the retractable sheath is withdrawn from the anchor when the retractable sheath is in its second retracted position; and

an outer tube fixedly mounted to the handle, the outer tube being disposed coaxially over the retractable sheath;

connecting the suture to the anchor; and

using the inserter to position the anchor in the bone, whereby to secure the suture to the bone.

25. A method according to claim 24 wherein the inserter comprises a movable tab, and further wherein the movable tab is used to withdraw the retractable sheath proximally before the anchor is positioned in the bone.

26. A method according to claim 24 wherein engagement of the retractable sheath with the bone causes the retractable sheath to be withdrawn proximally before the anchor is positioned in the bone.

27. A method according to claim 24 wherein the retractable sheath is spring-biased into its first extended position.