Pre-sutured anchor for implantable leads

• US 8,437,846 B2
• Filed: 03/11/2011
• Issued: 05/07/2013
• Est. Priority Date: 03/11/2011
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Swoyer, John, Geroy, Jesse, Finley, James
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US13/046,182
• Publication Number:
  US 20120232627A1
• Time in Patent Office: 788 Days
• Field of Search: None
• US Class Current: 607/2
• 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: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 2001/0582 Suture sleeves

Abstract

A pre-sutured anchor including a deformable anchor sleeve with a lumen sized to receive the therapy delivery element. An outer surface of the anchor sleeve including one or more annular compression grooves oriented generally co-axial to the lumen. At least one compression member is located in a compression groove in an open configuration. The compression member includes at least one stop. A suture material pre-tied in a self-locking compression knot extends around each compression member. The suture material includes distal ends adapted to receive a tension force that is transmitted as a radial compression force to deform the compression members and substantially engage the stop in a compressed configuration. The anchor sleeve compressively engages the therapy delivery element in the compressed configuration.

Claims

1. An anchor for securing a therapy delivery element to a desired location within a living body, the anchor comprising:

a deformable anchor sleeve comprising a lumen sized to receive the therapy delivery element, and an outer surface with one or more annular compression grooves oriented generally co-axial to the lumen;

at least one compression member located in a compression groove in an open configuration, the compression member comprising at least one stop; and

a suture material pre-tied in a self-locking compression knot extending around each compression member, the suture material comprising distal ends adapted to receive a tension force that is transmitted as a radial compression force to deform the compression members to engage the stop in a compressed configuration, the anchor sleeve compressively engaging the therapy delivery element in the compressed configuration.

2. The anchor of claim 1 wherein each compression member comprises one of a one-piece, C-shaped structure with one stop or a multi-piece structure with two or more stops.

3. The anchor of claim 1 wherein the compression member is generally concentrically oriented around the therapy delivery element in the compressed configuration.

4. The anchor of claim 1 comprising an adhesive retaining the compression members in the compression grooves.

5. The anchor of claim 1 comprising edges at the compression member to engage in the compressed configuration to limit application of the radial compression force on the anchor sleeve and the therapy delivery element.

6. The anchor of claim 1 wherein the compression members plastically deform in response to the radial compression force.

7. The anchor of claim 1 wherein the compression member comprises one of a thermoplastic material, stainless steel, or Nitinol.

8. The anchor of claim 1 wherein the self-locking compression knot comprises a nail knot.

9. The anchor of claim 1 wherein the self-locking compression knot comprises at least three loops around the compression member.

10. The anchor of claim 1 comprising at least one break-away tab attached to the distal ends of the suture material, the break-away tab limiting the tension force applied the suture material.

11. A neurostimulation system comprising:

an implantable pulse generator;

a therapy delivery element comprising a proximal end adapted to electrically couple with the implantable pulse generator and a distal end with a plurality of electrodes electrically coupled to the implantable pulse generator;

an anchor for securing the therapy delivery element in a desired location within a living body, the anchor comprising;

a deformable anchor sleeve comprising a lumen sized to receive the therapy delivery element, and an outer surface with one or more annular compression grooves oriented generally co-axial to the lumen;

at least one compression member located in a compression groove in an open configuration, the compression member comprising at least one stop;

a suture material pre-tied in a self-locking compression knot extending around each compression member, the suture material comprising distal ends adapted to receive a tension force that is transmitted as a radial compression force to deform the compression members to engage the stop in a compressed configuration, the anchor sleeve compressively engaging the therapy delivery element in the compressed configuration; and

a suture material adapted to secure the anchor to the living body.

12. A method of securing a therapy delivery element at a desired location within a living body, the method comprising the steps of:

inserting the therapy delivery element through a lumen of an anchor, the anchor comprising an outer surface with one or more annular compression grooves oriented generally co-axial to the lumen, at least one compression member located in a compression groove in an open configuration, and a suture material pre-tied in a self-locking compression knot extending around each compression member;

sliding the anchor along the therapy delivery element to the desired location;

attaching the anchor to the desired location within the living body;

applying a tension force to distal ends of the suture material that is transmitted as a radial compression force to deform the compression members to engage a stop on the compression member in a compressed configuration; and

compressively engaging the anchor to the therapy delivery element in the compressed configuration.

13. The method of claim 12 comprising retaining the compression members in the compression grooves with an adhesive.

14. The method of claim 12 comprising engaging edges of the compression member in the compressed configuration to limit application of the radial compression force on the anchor and the therapy delivery element.

15. The method of claim 12 comprising plastically deforming the compression member in response to the radial compression force.

16. The method of claim 12 comprising orienting the compression member generally concentric with the therapy delivery element in the compressed configuration.

17. The method of claim 12 comprising delivering a medical adhesive to at least one fill portion in the anchor.

18. A method of implanting a neurostimulation system within a living body, the method comprising the steps of:

implanting an implantable pulse generator within the living body;

positioning electrodes at a distal end of a therapy delivery element at a target location within the living body;

inserting a proximal end of the therapy delivery element through a lumen of an anchor, the anchor comprising an outer surface with one or more annular compression grooves oriented generally co-axial to the lumen, at least one compression member located in a compression groove in an open configuration, the compression member comprising at least one stop, and a suture material pre-tied in a self-locking compression knot extending around each compression member;

sliding the anchor along the therapy delivery element to the desired location;

attached the anchor to the desired location within the living body;

applying a tension force to distal ends of the suture material that is transmitted as a radial compression force to deform the compression members and engage the stop in a compressed configuration;

compressively engaging the anchor to the therapy delivery element in the compressed configuration; and

electrically coupling the proximal end of the therapy delivery element to the implantable pulse generator.

19. An anchor for securing a therapy delivery element to a desired location within a living body, the anchor comprising:

a deformable anchor sleeve comprising a lumen sized to receive the therapy delivery element, and an outer surface with one or more annular compression grooves oriented generally co-axial to the lumen;

one or more compression members located in the deformable anchor sleeve and

a suture material pre-tied in a self-locking compression knot extending around each compression member, the suture material comprising distal ends adapted to receive a tension force that is transmitted as a radial compression force to deform the anchor sleeve in a compressed configuration, the anchor sleeve compressively engaging the therapy delivery element in the compressed configuration.

20. The anchor of claim 19 comprising at least one compression member located in a compression groove in an open configuration, the compression member comprising at least one stop.