Intervertebral disc annulus repair system and method

• US 8,460,319 B2
• Filed: 08/10/2010
• Issued: 06/11/2013
• Est. Priority Date: 01/11/2010
• Status: Active Grant

• Current Assignee: KRT Investors, Inc.
• Original Assignee: Anulex Technologies, Inc.
• Inventors: Wales, Lawrence W., Bentley, Ishmael, Daley, Emily, Lancial, Michael
• Primary Examiner(s): Bui, Vy Q
• Application Number:
  US12/853,843
• Publication Number:
  US 20110172701A1
• Time in Patent Office: 1,036 Days
• Field of Search: 606/86.R, 606/144, 606/151, 606/213, 606/232, 128/898
• US Class Current: 606/144
• 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 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06185 hollow or tubular hollow suture needles A61B2017/061

Abstract

A device for at least partially closing an aperture in an annulus fibrosus of an intervertebral disc of a patient comprises an implant delivery tool and an implant releasably coupled to the implant delivery tool. The implant delivery tool includes a substantially rigid outer tube having a sharpened distal tip, a body a body coupled to the proximal section of the outer tube, and a plunger assembly movable axially relative to the body and including a plunger member and a pusher tube coupled thereto and disposed within the outer tube. The implant includes first and second tissue anchors serially disposed within the distal section of the outer tube, and a flexible connecting element coupling the first and second tissue anchors including a knotless braided suture structure for adjusting the length of the flexible coupling element.

Claims

1. A device for at least partially closing an aperture in an annulus fibrosus of an intervertebral disc of a patient, the device comprising:

an implant delivery tool including

a substantially rigid outer tube having a proximal section and a sharpened distal tip;

a body coupled to the proximal section of the outer tube;

a plunger assembly movable axially relative to the body and including a plunger member and a pusher tube coupled thereto and disposed within the outer tube; and

an implant releasably coupled to the implant delivery tool including;

first and second tissue anchors serially disposed within the distal section of the outer tube; and

a flexible connecting element coupling the first and second tissue anchors, the connecting element at least partially formed from a braided tubular suture material and including;

a distal segment of the braided suture material attached to the first tissue anchor;

an intermediate segment of the braided suture material extending proximally from the distal segment and including a locking element and an adjustable loop, wherein a portion of the intermediate segment extends internally within the braided suture material of the locking element, and wherein the second tissue anchor is slidably coupled to the braided suture material of the adjustable loop; and

a proximal segment of the braided suture material extending proximally from the intermediate segment and releasably coupled to the implant delivery tool.

2. The device of claim 1 wherein the pusher tube is displaceable within the outer tube from a first position to a second position to eject the first tissue anchor from the outer tube.

3. The device of claim 2 wherein the pusher tube is further displaceable within the outer tube from the second position to a third position to eject the second tissue anchor from the outer tube.

4. The device of claim 1 wherein the implant delivery tool includes a releasable tab releasably coupled to the plunger assembly.

5. The device of claim 4 wherein the connecting element is partially disposed within the outer tube and the proximal segment of the flexible connecting element is coupled to the releasable tab of the implant delivery tool.

6. A device for at least partially closing an aperture in an annulus fibrosus of an intervertebral disc of a patient, the device comprising:

an implant delivery tool including;

a substantially rigid outer tube having a proximal section, an intermediate section, and a distal section terminating in a sharpened tissue-piercing distal tip having an open end, the intermediate section having a first length, wherein the proximal and distal sections are laterally offset from one another by the intermediate section;

a body coupled to the proximal section of the outer tube;

a plunger assembly including a plunger member slidably disposed within the body, and a pusher tube slidably disposed within the body and the outer tube and coupled to the plunger member, the pusher tube including a distal end and a flexible segment proximal to the distal end axially coincident with the intermediate portion of the outer tube, the flexible segment having a second length greater than the first length of the intermediate portion of the outer tube; and

an implant releasably coupled to the implant delivery tool including a pair of tissue anchors serially disposed within the distal section of the outer tube, and an adjustable flexible connecting element connecting the tissue anchors,

wherein the plunger assembly is operable by a user to selectively displace the pusher tube distally within the outer tube so as to serially eject the first tissue anchor and then the second tissue anchor from the open end of the outer tube.

7. The device of claim 6 wherein the pusher tube is displaceable within the outer tube from a first position to a second position to eject the first tissue anchor from the outer tube.

8. The device of claim 7 wherein the pusher tube is further displaceable within the outer tube from the second position to a third position to eject the second tissue anchor from the outer tube.

9. The device of claim 8 wherein the intermediate section of the outer tube is axially coincident with at least a portion of the flexible segment of the pusher tube when the pusher tube is in the first, the second and the third positions.

10. The device of claim 6 wherein the implant delivery tool includes a releasable tab coupled to the plunger assembly.

11. The device of claim 10 wherein a first portion of the connecting element is disposed within the outer tube and a second portion of the flexible connecting element is coupled to the releasable tab of the implant delivery tool.

12. The device of claim 6 wherein the flexible connecting element has an adjustable length so as to allow separation between the tissue anchors to be reduced after deployment.

13. The device of claim 12 wherein the flexible connecting element is a knotless suture arrangement including a locking element substantially preventing elongation of the flexible connecting element between the tissue anchors after deployment.

14. The device of claim 6 wherein the flexible segment of the pusher tube includes a series of slots extending circumferentially about the pusher tube in a helical pattern, the slots imparting lateral flexibility to the flexible segment.

15. The device of claim 14 wherein the slots have an undulating shape.

16. The device of claim 6 wherein the flexible segment of the pusher tube is heat treated to impart lateral flexibility to the flexible segment.

17. The device of claim 6 wherein the flexible segment of the pusher tube is in the form of a helical spring.

18. The device of claim 6 wherein the proximal and distal sections of the outer tube are substantially parallel to one another.

19. The device of claim 6 wherein the intermediate section of the outer tube has a first curved portion extending from the proximal section and a second curved portion extending proximally from the distal section having an opposite curvature to that of the first curved portion.

20. A device for at least partially closing an aperture in an annulus fibrosus of an intervertebral disc of a patient, the device comprising:

an implant delivery tool including

a substantially rigid outer tube having a proximal section, a distal section, and an intermediate section having a non-linear shape laterally offsetting the proximal and distal sections from one another;

a body coupled to the proximal section of the outer tube;

a plunger assembly movable axially relative to the body and including a plunger member and a pusher tube coupled thereto and disposed within the outer tube, the pusher tube having a substantially rigid proximal segment, a substantially rigid distal segment including a distal end, and a flexible segment between the proximal and distal segments, wherein the pusher tube is slidably displaceable within the outer tube to assume a plurality of positions, and wherein the flexible segment is configured to conform to the nonlinear shape of the intermediate section of the outer tube in each of the plurality of positions of the pusher tube; and

an implant releasably coupled to the implant delivery tool including a pair of tissue anchors serially disposed within the distal section of the outer tube, and an adjustable flexible connecting element connecting the tissue anchors.

21. The device of claim 20 wherein the flexible segment of the pusher tube is dimensioned such that the intermediate section of the outer tube is axially coincident with at least a portion of the flexible segment in each of the plurality of positions of the pusher tube.

22. The device of claim 21 wherein the proximal and distal sections of the outer tube are substantially parallel to one another.

23. The device of claim 21 wherein the adjustable flexible connecting element is a knotless suture arrangement including a locking element substantially preventing elongation of the flexible connecting element between the tissue anchors after deployment.

24. The device of claim 21 wherein the flexible segment of the pusher tube includes a series of slots extending circumferentially about the pusher tube in a helical pattern, the slots imparting lateral flexibility to the flexible segment.

25. A system for at least partially closing an aperture in an annulus fibrosus of an intervertebral disc of a patient, the system comprising:

first and second repair devices each including;

an implant delivery tool including

a substantially rigid outer tube having a proximal section and a distal section terminating in a sharpened distal tip;

a body coupled to the proximal section of the outer tube;

a plunger assembly movable axially relative to the body and including a pusher tube disposed within the outer tube, wherein the pusher tube is slidably displaceable within the outer tube to assume a plurality of positions; and

an implant releasably coupled to the implant delivery tool including;

first and second tissue anchors serially disposed within the distal section of the outer tube; and

a flexible connecting element coupling the first and second tissue anchors, the connecting element at least partially formed from a braided tubular suture material and including;

a distal segment of the braided suture material attached to the first tissue anchor;

an intermediate segment of the braided suture material extending proximally from the distal segment and including a locking element and an adjustable loop, wherein a portion of the intermediate segment extends internally within the braided suture material of the locking element, and wherein the second tissue anchor is slidably coupled to the braided suture material of the adjustable loop; and

a proximal segment of the braided suture material extending proximally from the intermediate segment and releasably coupled to the implant delivery tool.