Ratcheting inserter device and suture anchor arrangement

• US 10,702,258 B2
• Filed: 08/04/2016
• Issued: 07/07/2020
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Howmedica Osteonics Corp. (Stryker Corporation)
• Original Assignee: Howmedica Osteonics Corp. (Stryker Corporation)
• Inventors: Moore, Kurt Hamilton, Napolitano, Anthony Patrick
• Primary Examiner(s): Szpira, Julie A
• Application Number:
  US15/228,323
• Publication Number:
  US 20160338690A1
• Time in Patent Office: 1,433 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 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 2017/00407 Ratchet means
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• 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 2017/0425 the anchor or the separate member comprising threads, e.g. a set screw in the anchor
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/045 snug fit within the anchor
• CPC Class Codes: A61B 2017/0453 threaded elements, e.g. set screws

Abstract

A ratcheting inserter device for tensioning a knotless suture anchor includes an outer inserter shaft and an inner inserter shaft having a common longitudinal axis. A ratcheting mechanism provided between the inner inserter shaft and the outer inserter shaft permits rotation of the inner inserter shaft in one direction relative to the outer inserter shaft. The outer inserter shaft has a protrusion at a distal end that is received by an anchor outer sleeve of a suture anchor to prevent relative rotation thereof, and the inner inserter shaft has a projection at the distal end that is received by an inner core of the anchor for rotational movement therewith. The ratcheting inserter device rotates the inner core of the suture anchor to spool and tension suture thread. Thereafter, the ratcheting mechanism is disengaged and the inner inserter shaft is forced axially into the anchor outer sleeve.

Claims

1. A method for securing a suture anchor into a bone comprising:

providing a suture anchor comprising an anchor inner core and an anchor outer sleeve having an open bore hole at a proximal end for receiving and enclosing a first portion of the anchor inner core;

driving the suture anchor into bone with an inserter device to dispose the proximal end of the anchor outer sleeve adjacent a bone surface;

tensioning suture threads coacting with the suture anchor by moving an inner inserter shaft of the inserter device in a first direction to rotate the anchor inner core relative to the anchor outer sleeve; and

securing the anchor inner core to the anchor outer sleeve by moving the inner inserter shaft in a second direction different from the first direction.

2. The method of claim 1, wherein the anchor inner core includes core threads at the proximal end thereof, and wherein the anchor outer sleeve includes an inner threaded region in the open bore hole at the proximal end thereof, and further including driving the anchor inner core into the anchor outer sleeve comprising simultaneously applying an axial force and a rotating force for rotating the anchor inner core into the anchor outer sleeve.

3. The method of claim 1, wherein the anchor inner core includes at least one projection and the anchor inner core is formed of a first material and the anchor outer sleeve is formed of a second material, the first material being harder than the second material, wherein, during the securing step, the at least one projection of the anchor inner core cuts the anchor outer sleeve.

4. The method of claim 1, including the step of moving a portion of the inserter device away from the suture anchor to release tension of the suture threads.

5. The method of claim 1, wherein the inserter device comprises:

a hollow outer inserter shaft having an outer shaft distal end and an outer shaft proximal end;

a protrusion projecting from the outer shaft distal end of the outer inserter shaft;

a handle having a handle distal end and a handle proximal end, the handle distal end being connected to the outer shaft proximal end of the outer inserter shaft, with the outer inserter shaft extending from the handle;

the inner inserter shaft having an inner shaft distal end and an inner shaft proximal end, the inner inserter shaft extending at least partially through the outer inserter shaft and the handle;

an inner shaft control connected to the inner shaft proximal end of the inner inserter shaft at the handle proximal end;

a projection projecting from the inner shaft distal end of the inner inserter shaft; and

a ratcheting mechanism permitting rotation of the inner inserter shaft in one direction relative to the outer inserter shaft and preventing rotation of the inner inserter shaft in an opposing direction relative to the outer inserter shaft;

wherein the inner inserter shaft is rotatable relative to the outer inserter shaft in the one direction.

6. The method of claim 5, wherein the ratcheting mechanism comprises at least one stationary pawl formed in one of an outer surface of the inner inserter shaft and an inner surface of the outer inserter shaft.

7. The method of claim 6, wherein the ratcheting mechanism further comprises teeth formed in the other of the outer surface of the inner inserter shaft and the inner surface of the outer inserter shaft for engaging the at least one stationary pawl to prevent rotation of the inner inserter shaft in the opposing direction.

8. The method of claim 7, wherein the teeth and the at least one stationary pawl are aligned radially toward each other along a portion of the inner inserter shaft and the outer inserter shaft.

9. The method of claim 5, wherein the protrusion comprises a flange extending distally beyond the outer shaft distal end and the inner shaft distal end, and the inner shaft control comprises an inner shaft knob.

10. The method of claim 5, including a spacer axially disposed between the handle and the inner shaft control.

11. The method of claim 10, wherein removal of the spacer enables a force, applied to the inner shaft control toward a distal end of the ratcheting inserter device, to axially move the inner shaft distal end of the inner inserter shaft outwardly beyond the outer shaft distal end of the outer inserter shaft for driving the anchor inner core of the suture anchor into the anchor outer sleeve of the suture anchor.

12. The method of claim 11, wherein the inner shaft control includes a projecting screw shaft oriented along a common longitudinal axis of the outer inserter shaft and the inner inserter shaft, and the handle includes an open bore with matching screw threads for receiving the projecting screw shaft, and wherein axial movement of the inner inserter shaft disengages the ratcheting mechanism, whereby the inner shaft control is capable of rotating in the opposing direction.

13. The method of claim 5, further including a spacer axially disposed between the handle and the inner shaft control;

wherein removal of the spacer enables a force, applied to the inner shaft control toward a device distal end of the ratcheting inserter device, to axially move the inner shaft distal end of the inner inserter shaft outwardly beyond the outer shaft distal end of the outer inserter shaft for driving the anchor inner core into the anchor outer sleeve;

the inner shaft control includes a projecting screw shaft oriented along a common longitudinal axis of the outer inserter shaft and the inner inserter shaft, and the handle includes an open bore with matching screw threads for receiving the projecting screw shaft, and wherein axial movement of the inner inserter shaft disengages the ratcheting mechanism, whereby the inner shaft control is capable of rotating in the opposing direction; and

wherein the anchor outer sleeve includes an inner threaded region at an outer sleeve proximal end and the anchor inner core includes core threads at a core proximal end, and wherein during movement of the inner shaft control rotatably and axially into the handle and toward the suture anchor, the inner shaft distal end of the inner inserter shaft rotatably and axially drives the core threads of the anchor inner core into the inner threaded region of the anchor outer sleeve.

14. The method of claim 13, wherein the inner shaft control rotates in a range from about a one quarter rotation and about a three quarter rotation to axially advance the inner inserter shaft a distance that corresponds to a width of the spacer.

15. The method of claim 11, wherein the ratcheting mechanism comprises a first ratcheting mechanism and axial movement of the inner inserter shaft disengages the first ratcheting mechanism, and wherein a second ratcheting mechanism axially spaced from the first ratcheting mechanism engages the inner inserter shaft to limit rotation thereof.

16. The method of claim 5, wherein the projection is configured to fit into the open bore hole of the anchor inner core of the suture anchor and the projection is configured to rotate the anchor inner core of the suture anchor for tensioning the suture threads coacting with the suture anchor.

17. The method according to claim 5, wherein the inner shaft control is movable axially away from the handle to disengage the ratcheting mechanism and to enable rotation of the inner inserter shaft in each direction relative to the outer inserter shaft.

18. The method of claim 5, wherein movement of the inner inserter shaft relative to the outer inserter shaft drives the anchor inner core of the suture anchor into the anchor outer sleeve of the suture anchor.

19. The method of claim 5, wherein the ratcheting mechanism is located outside of the handle.

20. The method of claim 19, wherein the ratcheting mechanism is located in the outer inserter shaft.

21. The method of claim 5, wherein an outer shaft axial length of the outer inserter shaft is longer than a handle axial length of the handle.

22. The method of claim 21, wherein an inner shaft axial length of the inner inserter shaft is longer than the outer shaft axial length of the outer inserter shaft.

23. The method of claim 5, wherein the outer shaft distal end of the outer inserter shaft defines a substantially circular surface and the protrusion is cantilevered from the substantially circular surface.

24. The method of claim 5, wherein the inner inserter shaft is movable axially within the outer inserter shaft between an open position and a ratcheting position, and the ratcheting mechanism prevents rotation of the inner inserter shaft in the opposing direction relative to the outer inserter shaft when the inner inserter shaft is in the ratcheting position.

25. The method of claim 5, wherein an outer shaft outer diameter of the outer inserter shaft is smaller than a handle outer diameter of the handle.

26. The method of claim 1, wherein a second portion of the anchor inner core extends away from the proximal end of the anchor outer sleeve.

27. A method for securing a suture anchor into a bone comprising:

providing a suture anchor comprising an anchor inner core and an anchor outer sleeve having an open bore hole at a proximal end for receiving and enclosing a first portion of the anchor inner core with a second portion of the anchor inner core extending away from the proximal end of the anchor outer sleeve;

driving the suture anchor into bone with an inserter device to dispose the proximal end of the anchor outer sleeve adjacent a bone surface; and

tensioning suture threads coacting with the suture anchor;

driving the anchor inner core into the anchor outer sleeve;

wherein the inserter device comprises;

a hollow outer inserter shaft having an outer shaft distal end and an outer shaft proximal end;

a protrusion projecting from the outer shaft distal end of the outer inserter shaft;

a handle having a handle distal end and a handle proximal end, the handle distal end being connected to the outer shaft proximal end of the outer inserter shaft, with the outer inserter shaft extending from the handle;

an inner inserter shaft having an inner shaft distal end and an inner shaft proximal end, the inner inserter shaft extending at least partially through the outer inserter shaft and the handle;

an inner shaft control connected to the inner shaft proximal end of the inner inserter shaft at the handle proximal end;

a projection projecting from the inner shaft distal end of the inner inserter shaft; and

a ratcheting mechanism permitting rotation of the inner inserter shaft in one direction relative to the outer inserter shaft and preventing rotation of the inner inserter shaft in an opposing direction relative to the outer inserter shaft;

wherein the inner inserter shaft is rotatable relative to the outer inserter shaft in the one direction;

wherein movement of the inner inserter shaft relative to the outer inserter shaft drives the anchor inner core of the suture anchor into the anchor outer sleeve of the suture anchor; and

wherein the anchor outer sleeve defines a bore therein which opens proximally through an outer sleeve proximal end of the anchor outer sleeve and in which the anchor inner core is disposed.

28. The method of claim 27, wherein the anchor inner core has a bore opening proximally through an inner core proximal end of the anchor inner core, the projection of the inner inserter shaft being engaged within the bore of the anchor inner core and configured to rotate the anchor inner core relative to the anchor outer sleeve for tensioning sutures mounted on the suture anchor.

29. The method of claim 28, wherein the outer sleeve proximal end of the anchor outer sleeve includes an inner threaded region located within the bore thereof and the inner core proximal end of the anchor inner core includes an outer threaded region engaged with the inner threaded region of the anchor outer sleeve through movement of the inner shaft control.

30. The method of claim 27, wherein the anchor inner core has an inner core proximal end disposed adjacent the outer sleeve proximal end of the anchor outer sleeve, and the inner core proximal end and the outer sleeve proximal end include respective complementary mating structures which permit advancement of the anchor inner core into the bore of the anchor outer sleeve in a direction substantially parallel to a longitudinal axis of the suture anchor.

31. The method of claim 27, wherein the anchor inner core has a bore opening proximally through an inner core proximal end of the anchor inner core, the anchor inner core and the anchor outer sleeve each having an aperture oriented transversely to a longitudinal axis of the suture anchor for disposition of a suture, the anchor inner core being rotatably disposed within the bore of the anchor outer sleeve.

32. The method of claim 31, wherein the inner core proximal end of the anchor inner core and the outer sleeve proximal end of the anchor outer sleeve are threaded and engage one another to allow advancement of the anchor inner core relative to the anchor outer sleeve in a direction substantially parallel to a longitudinal axis of the suture anchor.

33. The method of claim 31, wherein the inner core proximal end of the anchor inner core includes a plurality of substantially axially extending flanges configured to cut into the anchor outer sleeve when the anchor inner core is advanced relative to the anchor outer sleeve in a direction substantially parallel to a longitudinal axis of the suture anchor.

34. A method for securing a suture anchor into a bone comprising:

providing a suture anchor comprising an anchor inner core and an anchor outer sleeve having an open bore hole at a proximal end for receiving and enclosing a first portion of the anchor inner core;

driving the suture anchor into bone with an inserter device to dispose the proximal end of the anchor outer sleeve adjacent a bone surface; and

tensioning suture threads coacting with the suture anchor;

wherein the inserter device comprises;

a hollow outer inserter shaft having an outer shaft distal end and an outer shaft proximal end;

a protrusion projecting from the outer shaft distal end of the outer inserter shaft;

a handle having a handle distal end and a handle proximal end, the handle distal end being connected to the outer shaft proximal end of the outer inserter shaft, with the outer inserter shaft extending from the handle;

an inner inserter shaft having an inner shaft distal end and an inner shaft proximal end, the inner inserter shaft extending at least partially through the outer inserter shaft and the handle;

an inner shaft control connected to the inner shaft proximal end of the inner inserter shaft at the handle proximal end;

a projection projecting from the inner shaft distal end of the inner inserter shaft; and

a ratcheting mechanism permitting rotation of the inner inserter shaft in one direction relative to the outer inserter shaft and preventing rotation of the inner inserter shaft in an opposing direction relative to the outer inserter shaft;

wherein the inner inserter shaft is rotatable relative to the outer inserter shaft in the one direction;

wherein movement of the inner inserter shaft relative to the outer inserter shaft drives the anchor inner core of the suture anchor into the anchor outer sleeve of the suture anchor; and

wherein the anchor outer sleeve defines a bore therein which opens proximally through an outer sleeve proximal end of the anchor outer sleeve and in which the anchor inner core is disposed.