Tissue fixation and repair systems and methods
A system and method for securing an implantable medical device to an anatomical feature, such as bony structures and/or soft tissues near the spine. The system includes a tissue fixation device and a tissue fixation device delivery tool. The tissue fixation device includes at least one bone or tissue anchor and a connecting element coupled thereto. The tissue fixation device optionally includes a flexible anchoring strap for engaging the implantable medical device. The bone or tissue anchor are configured to be deployed into the anatomical feature, and the connecting element is tightened to secure the implantable medical device to the anatomical feature.
1. A method of securing an implantable medical device to or adjacent to an anatomical feature in a patient, the method comprising:
providing a fixation device coupled to a delivery tool, the delivery tool including a needle cannula having a distal tip, the fixation device including at least one anchor member and a flexible suture assembly including a connecting segment and an adjustable suture loop, wherein the at least one anchor member comprises a first anchor member with a channel, wherein the connecting segment comprises a distal locking element and a proximal locking element disposed on opposite sides of the channel of the first anchor member, wherein each of the distal locking element and the proximal locking element comprises a knot, wherein the adjustable suture loop pierces through the connecting segment between the first anchor member and the proximal locking element;
inserting the distal tip of the needle cannula into the anatomical feature;
ejecting the at least one anchor member from the distal tip of the needle cannula into the anatomical feature;
inserting the implantable medical device within the adjustable suture loop, wherein the implantable medical device is a neurostnnulation lead; and
reducing a dimension of the adjustable suture loop to tighten the adjustable suture loop about the implantable medical device.
2. The method of claim 1 , wherein:
the implantable medical device includes a flexible member and a compressible anchoring sleeve disposed about the flexible member;
inserting the implantable medical device within the adjustable suture loop includes positioning the anchoring sleeve within the adjustable suture loop; and
reducing the dimension of the adjustable suture loop to tighten the adjustable suture loop about the implantable medical device includes tightening the adjustable suture loop about the anchoring sleeve.
3. The method of claim 2 , wherein the at least one anchor member includes a bone anchor and the anatomical feature includes a bony structure.
4. The method of claim 3 , wherein the bony structure is a vertebral body.
5. The method of claim 4 , wherein the fixation device further includes a soft tissue anchor slidably coupled to the adjustable suture loop, and wherein the anatomical feature further includes soft tissue proximate the vertebral body, and wherein the method further comprises removing the distal tip of the needle cannula from the vertebral body and subsequently inserting the distal tip of the needle cannula into the soft tissue and ejecting the soft tissue anchor into the soft tissue prior to reducing the dimension of the adjustable suture loop to tighten the adjustable suture loop about the anchoring sleeve.
6. The method of claim 1 , further comprising positioning a compressible anchoring sleeve over a portion of the implantable medical device.
7. The method of claim 6 , wherein the compressible anchoring sleeve comprises at least one circumferential groove.
8. The method of claim 7 , wherein reducing the dimension of the adjustable suture loop comprises tightening the adjustable suture loop about the anchoring sleeve so that a portion of the adjustable suture loop is positioned within at least one of the at least one circumferential groove.
9. The method of claim 6 , wherein positioning the compressible anchoring sleeve comprises slidably positioning the compressible anchoring sleeve over the portion of the implantable medical device.
10. The method of claim 1 , wherein the flexible suture assembly further includes a proximal tension line configured and arranged for tightening the adjustable suture loop.
11. The method of claim 1 , wherein the flexible suture assembly further includes a proximal tension line configured and arranged for tightening the adjustable suture loop and a safety line extending proximally from the proximal locking element.
12. The method of claim 11 , wherein providing the fixation device coupled to the delivery tool comprises providing the fixation device with the proximal tension line and safety line extending external to the needle cannula of the delivery tool.
13. The method of claim 12 , wherein the delivery tool further includes a handle coupled to the needle cannula and at least one releasable tab coupled to the handle.
14. The method of claim 13 , wherein providing the fixation device with the proximal tension line and the safety line extending external to the needle cannula of the delivery tool comprises providing the fixation device with the proximal tension line and safety line extending external to the needle cannula and connected to the at least one releasable tab.
15. The method of claim 14 , further comprising using the at least one tab to apply tension to the safety line to rotate or toggle the first anchor member.
16. The method of claim 14 , wherein reducing the dimension of the adjustable suture loop comprises using the at least one tab to pull on the proximal tension line to tighten the adjustable suture loop about the implantable medical device.
17. The method of claim 1 , wherein the flexible suture assembly further includes a proximal tension line configured and arranged for tightening the adjustable suture loop and a safety line coupled to the adjustable suture loop.
18. The method of claim 17 , wherein providing the fixation device coupled to the delivery tool comprises providing the fixation device with the proximal tension line and the safety line extending external to the needle cannula of the delivery tool.
19. The method of claim 18 , wherein the delivery tool further includes a handle coupled to the needle cannula and at least one releasable tab coupled to the handle.
20. The method of claim 19 , wherein providing the fixation device with the proximal tension line and safety line extending external to the needle cannula of the delivery tool comprises providing the fixation device with the proximal tension line and safety line extending external to the needle cannula and connected to the at least one releasable tab.
21. The method of claim 20 , further comprising using the at least one tab to apply tension to the safety line to rotate or toggle the at least one anchor member.
22. The method of claim 20 , wherein reducing the dimension of the adjustable suture loop comprises using the at least one tab to pull on the proximal tension line to tighten the adjustable suture loop about the implantable medical device.