Intervertebral disc annulus repair system and bone anchor delivery tool

• US 8,652,153 B2
• Filed: 08/10/2010
• Issued: 02/18/2014
• Est. Priority Date: 01/11/2010
• Status: Active Grant

• Current Assignee: KRT Investors, Inc.
• Original Assignee: Anulex Technologies, Inc.
• Inventors: Brady, Dale, Wales, Lawrence W., Bentley, Ishmael
• Primary Examiner(s): Bui, Vy Q
• Application Number:
  US12/853,897
• Publication Number:
  US 20110172682A1
• Time in Patent Office: 1,288 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

An intervertebral disc repair system comprises an implant and a delivery tool configured to deploy the implant at least partially in a vertebral body of a patient. The implant includes an anchor member and an adjustable suture assembly coupled thereto. The delivery tool includes a proximal handle, an outer tubular member extending distally from the handle, a needle cannula slidably received within the outer tubular member having a sharpened tip for penetrating tissue (e.g., the vertebral body), an inner pusher member slidably received within the needle cannula, and an actuating mechanism coupled to the handle for selectively retracting the needle cannula relative to the outer tubular member and the inner pusher member. At least the anchor member of the implant is releasably received within the needle cannula.

Claims

1. An intervertebral disc repair system comprising:

an implant including an anchor member and an adjustable suture assembly coupled thereto, the adjustable suture assembly forming an adjustable loop and including a tension line having a proximal end, and a toggle line coupled to the anchor member for selectively rotating the anchor member during deployment thereof; and

a delivery tool including;

a proximal handle,

an outer tubular member extending distally from the handle and having an open distal end,

a needle cannula slidably received within the outer tubular member having a proximal portion with a proximal end, and an open distal end terminating with a sharpened tip for penetrating tissue,

an inner pusher member slidably received within the needle cannula and having a proximal end and a distal end, and

an actuating mechanism coupled to the handle for selectively retracting the needle cannula relative to the outer tubular member and the inner pusher member,

wherein the proximal end of the tension line of the implant is operable by the user to reduce at least one dimension of the loop,

wherein the anchor member and at least a portion of the adjustable suture assembly of the implant are releasably received within the needle cannula distal to the distal end of the inner pusher member,

wherein the delivery tool is configured such that actuation of the actuating mechanism proximally retracts the needle cannula relative to the outer tubular member and the inner pusher member to release the anchor member from the needle cannula, and

wherein the toggle line of the adjustable suture assembly of the implant is operable to cause rotation of the anchor member as the anchor member is released from the needle cannula.

2. The system of claim 1 wherein the delivery tool is configured such that the needle cannula and the inner pusher member can be axially advanced together relative to the outer tubular member.

3. The system of claim 2 wherein the delivery tool is configured such that the needle cannula is retractable relative to the inner pusher member upon actuation of the actuating member after axially advancing the needle cannula and the inner pusher member relative to the outer tubular member.

4. The system of claim 3 wherein the delivery tool is configured to prevent proximal movement of the inner pusher member upon retraction of the needle cannula relative to the inner pusher member and the outer tubular member.

5. The system of claim 3 wherein the adjustable suture assembly includes a knotless locking element configured to prevent elongation of the adjustable loop.

6. The system of claim 1 wherein the handle of the delivery tool includes a tubular upper portion having a proximal end, and a lower portion extending from the upper portion adapted to be gripped by the user, wherein the outer tubular member extends distally from the tubular upper portion of the handle such that the upper portion of the handle and the outer tubular member define a longitudinal axis of the delivery tool, and wherein the needle cannula and the inner pusher member of the delivery tool are aligned with the longitudinal axis.

7. The system of claim 6 wherein the proximal end of the inner pusher member further includes an end plate extending radially from the inner pusher member.

8. The system of claim 6 wherein the delivery tool includes a releasable tab coupled to the proximal end of the second implant tension line, the releasable tab operable by the user to apply tension to the tension line to reduce the at least one dimension of the loop, the releasable tab further releasably coupled to the inner pusher member between the end plate and the proximal end of the upper portion of the handle preventing axial movement of the inner pusher member.

9. The system of claim 1 wherein the proximal portion of the needle cannula further includes a flange having an aperture therein, and wherein the toggle line has a proximal end portion connected to the flange.

10. The system of claim 9 wherein the delivery tool is further configured such that actuation of the actuating mechanism proximally retracts the needle cannula thereby applying tension to the toggle line to rotate the anchor member as the anchor member is released from the needle cannula.

11. An intervertebral disc repair system for repairing a defect in an intervertebral disc of a patient, the system comprising:

a first implant including first and second tissue anchors, and an adjustable connecting element connecting the first and second tissue anchors, the adjustable connecting element having an adjustable length between the first and second tissue anchors;

a first delivery tool including a tissue penetrating tubular member, the first and second tissue anchors releasably received in the tubular member, the first delivery tool configured to deploy the first and second tissue anchors in the intervertebral disc;

a second implant including an anchor member and an adjustable suture assembly coupled thereto, the adjustable suture assembly forming an adjustable loop and including a tension line having a proximal end operable by a user to reduce at least one dimension of the adjustable loop, and a toggle line coupled to the anchor member for rotating the anchor member during deployment thereof; and

a second delivery tool including a proximal handle, an outer tubular member extending distally from the handle and having an open distal end, a needle cannula slidably received within the outer tubular member having a proximal portion with a proximal end and an open distal end terminating with a sharpened tip for penetrating tissue, an inner pusher member slidably received within the needle cannula and having a proximal end and a distal end, and an actuating mechanism coupled to the handle for selectively adjusting an axial position of the needle cannula relative to the outer tubular member and the inner pusher member,

wherein the anchor member and at least a portion of the adjustable suture assembly of the second implant are releasably received within the needle cannula of the second delivery tool,

wherein the toggle line of the adjustable suture assembly of the second implant is operable to cause rotation of the anchor member during deployment thereof upon actuation of the actuating mechanism by a user,

and wherein the adjustable suture assembly and the connecting element are configured to be interconnected and placed under tension after deployment of the anchor member and the first and second tissue anchors.

12. The system of claim 11 wherein the second delivery tool is configured such that the needle cannula and the inner pusher member can be axially advanced together relative to the outer tubular member.

13. The system of claim 12 wherein the second delivery tool is further configured such that the needle cannula is retractable relative to the inner pusher member upon actuation of the actuating member after axially advancing the needle cannula and the inner pusher member relative to the outer tubular member.

14. The system of claim 13 wherein the second delivery tool is configured to prevent proximal movement of the inner pusher member during retraction of the needle cannula relative to the inner pusher member and the outer tubular member so as to cause the anchor member to be released from the needle cannula.

15. The system of claim 11 wherein the second delivery tool includes a releasable tab coupled to the proximal end of the second implant tension line, the releasable tab operable by the user to apply tension to the tension line to reduce the at least one dimension of the loop.

16. The system of claim 11 wherein the second delivery tool is configured such that actuation of the actuating mechanism proximally retracts the needle cannula relative to the outer tubular member and the inner pusher member to release the anchor member from the needle cannula.

17. The system of claim 16 wherein the proximal portion of the needle cannula of the second delivery tool further includes a flange having an aperture therein, and wherein the toggle line has a proximal end portion connected to the flange.

18. The system of claim 16 wherein the second delivery tool is further configured such that actuation of the actuating mechanism proximally retracts the needle cannula thereby applying tension to the toggle line as the anchor member is released from the needle cannula.

19. The system of claim 11 wherein the handle of the second delivery tool includes a tubular upper portion having a proximal end and a lower portion extending from the upper portion adapted to be gripped by the user, wherein the outer tubular member extends distally from the tubular upper portion of the handle such that the upper portion of the handle and the outer tubular member define a longitudinal axis of the second delivery tool, and wherein the needle cannula and the inner pusher member of the second delivery tool are aligned with the longitudinal axis.

20. The system of claim 19 wherein the proximal end of the inner pusher member extends proximally from the upper portion of the second delivery tool handle.

21. The system of claim 20 wherein the proximal end of the inner pusher member further includes an end plate extending radially from the inner pusher member relative to the longitudinal axis.

22. The system of claim 19 wherein the releasable tab is releasably coupled to the inner pusher member between the end plate and the proximal end of the upper portion of the handle preventing axial movement of the inner pusher member.

23. The system of claim 11 further comprising a tension guide including:

a first end having a canted tip and a first slot therein sized to slidingly receive portions of the connecting element of the first implant and the suture assembly of the second implant; and

a second end having a tip with a second slot therein, and a recessed blade with a cutting edge exposed within the second slot, the second slot sized to slidingly receive portions of the connecting element of the first implant and the suture assembly of the second implant, the cutting edge configured to cut the connecting element and the suture assembly to remove excess portions thereof.

24. The system of claim 23 wherein the cutting edge of the tension guide blade is oriented toward the tip of the second end of the tension guide.

25. A tissue repair system comprising:

an implant including an anchor member and an adjustable suture assembly coupled thereto, the adjustable suture assembly forming an adjustable loop and including a tension line having a proximal end, and a toggle line coupled to the anchor member for selectively rotating the anchor member during deployment thereof; and

a delivery tool including;

a proximal handle,

an outer tubular member extending distally from the handle and having an open distal end,

a needle cannula slidably received within the outer tubular member having a proximal portion with a proximal end, and an open distal end terminating with a sharpened tip for penetrating tissue,

an inner pusher member slidably received within the needle cannula and having a proximal end and a distal end, and

an actuating mechanism coupled to the handle for selectively retracting the needle cannula relative to the outer tubular member and the inner pusher member,

wherein the proximal end of the tension line of the implant is operable by the user to reduce at least one dimension of the loop,

wherein the anchor member and at least a portion of the adjustable suture assembly of the implant are releasably received within the needle cannula distal to the distal end of the inner pusher member,

wherein the delivery tool is configured such that actuation of the actuating mechanism proximally retracts the needle cannula relative to the outer tubular member and the inner pusher member to release the anchor member from the needle cannula, and

wherein the toggle line of the adjustable suture assembly of the implant is operable to cause rotation of the anchor member as the anchor member is released from the needle cannula.