Anchor for implantable medical device

• US 8,483,845 B2
• Filed: 03/11/2011
• Issued: 07/09/2013
• Est. Priority Date: 03/11/2011
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Sage, Shahn S.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Sarcione, Jessica
• Application Number:
  US13/045,874
• Publication Number:
  US 20120232624A1
• Time in Patent Office: 851 Days
• Field of Search: 607115-117, 607/126, 607/132, 607/149, 606/232, 604174-175, 604/177
• US Class Current: 607/117
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system

Abstract

An anchor for an implantable medical device, anchor delivery tools, kits, and methods, all directed to securing a therapy delivery element at a target location in a patient. An anchor for a therapy delivery element having an outer surface about which the anchor is disposable. The anchor includes a body portion having elastomeric properties, a first opening, a second opening, and a non-linear lumen extending though the body portion from the first opening to the second opening in a relaxed state. The non-linear lumen becomes a linear lumen in a stretched state. The linear lumen of the body portion is adapted to receive the therapy delivery element and the non-linear lumen frictionally engages the outer surface of the therapy delivery element in the relaxed state.

Claims

1. An anchor for a therapy delivery element having an outer surface about which the anchor is disposable, the anchor comprising:

a body portion having elastomeric properties comprising a first opening, a second opening, and a non-linear lumen extending though the body portion from the first opening to the second opening in a relaxed state, and a linear lumen in a stretched state, wherein the linear lumen of the body portion is adapted to receive the therapy delivery element in the stretch state, and the non-linear lumen of the body portion frictionally engages the outer surface of the therapy delivery element in the relaxed state.

2. The anchor of claim 1 wherein the therapy delivery element generally assumes a shape of the non-linear lumen in the relaxed state.

3. The anchor of claim 1 wherein at least a portion of the therapy delivery element has a cross-sectional area greater than a cross-sectional area of the non-linear lumen in the relaxed state, such that the body portion compressively engages the therapy delivery element.

4. The anchor of claim 1 wherein the non-linear lumen comprises one of serpentine, tortuous, curved, non-straight, or curvilinear.

5. The anchor of claim 1 wherein the body portion comprises:

a first body portion having a first opening, a second opening, and a first lumen extending though the first body portion from the first opening to the second opening;

a second body portion having a first opening, a second opening, and a second lumen extending though the second body portion from the first opening to the second opening; and

a flexible tab attaching the first body portion to the second body portion such that the first and second lumens are non-aligned in the relaxed state.

6. The anchor of claim 5 wherein the first and second lumens are one of parallel or perpendicular with respect to each other in the relaxed state.

7. The anchor of claim 5 wherein the therapy delivery element generally assumes the alignment first and second lumens in the relaxed state.

8. The anchor system of claim 1 wherein the body portion comprises one or more annular ribs.

9. The anchor of claim 1 comprising at least one retention member with a suture hole attached to the anchor.

10. An anchor system comprising:

an anchor of claim 1; and

an anchor delivery tool comprising an anchor delivery tube with a delivery lumen adapted to receive the therapy delivery element, and an outer surface with a cross-sectional area greater than a cross-sectional area of the linear lumen of the body portion in the stretch state, such that the linear lumen of the body portion compressively engages the delivery tube.

11. The anchor system of claim 10 wherein the anchor delivery tube is adapted to retract into the anchor delivery tool to deploy the anchor onto the outer surface of the therapy delivery element.

12. A kit comprising:

a first anchor comprising a body portion having elastomeric properties, the body portion comprising a first opening, a second opening, and a first non-linear lumen extending though the body portion from the first opening to the second opening in a relaxed state, and a first linear lumen in a stretched state, wherein the first linear lumen of the body portion is adapted to receive a therapy delivery element and the first non-linear lumen of the body portion frictionally engages an outer surface of the therapy delivery in the relaxed state;

a second anchor comprising a body portion having elastomeric properties, the body portion comprising a first opening, a second opening, and a second non-linear lumen extending though the body portion from the first opening to the second opening in a relaxed state, and a second linear lumen in a stretched state, wherein the second linear lumen of the body portion is adapted to receive the therapy delivery element and the second non-linear lumen of the body portion frictionally engages the outer surface of the therapy delivery in the relaxed state, wherein the first non-linear lumen comprises a configuration different than the second non-linear lumen;

a therapy delivery element having an outer surface about which the body portion of the first or second anchors is disposable; and

an anchor delivery tool comprising an anchor delivery tube with a delivery lumen adapted to receive the therapy delivery element, and an outer surface with a cross-sectional area greater than a cross-sectional area of the first and second linear lumens of the body portions in the stretch state, such that the body portions compressively engage the delivery tube.

13. A method of delivering an anchor for an implantable medical device in a patient, the method comprising the steps of:

stretching an elastomeric body portion of an anchor to convert a relaxed non-linear lumen to a stretched linear lumen;

inserting an anchor delivery tube into the linear lumen, the linear lumen having a cross-sectional area less than a cross-sectional area of the delivery tube, such that the body portion compressively engages the delivery tube in a stretched state;

inserting a therapy delivery element into a lumen in the anchor delivery tube;

positioning the anchor delivery tube relative to the therapy delivery element where the anchor is to be located;

retracting the anchor delivery tube into an anchor delivery tool so that the anchor resumes a relaxed state and the non-linear lumen of the body portion frictionally engages the outer surface of the therapy delivery in the relaxed state;

suturing the anchor to the patient; and

removing the anchor delivery tube from the therapy delivery element.

14. The method of claim 13 comprising the therapy delivery element generally assuming a non-linear shape of the non-linear lumen when the body portion is in the relaxed state.

15. The method of claim 13 comprising the non-linear lumen compressively engaging the therapy delivery element in the relaxed state.

16. 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;

stretching a non-linear lumen extending through an elastomeric body portion of an anchor to insert an anchor delivery tube, the non-linear lumen having a cross-sectional area less than a cross-sectional area of the delivery tube, such that the body portion compressively engages the delivery tube in a stretched state;

inserting a therapy delivery element into a lumen in the anchor delivery tube;

positioning the anchor delivery tube relative to the therapy delivery element where the anchor is to be located;

retracting the anchor delivery tube into an anchor delivery tool so that the anchor resumes a relaxed state and the non-linear lumen of the body portion frictionally engages the outer surface of the therapy delivery in the relaxed state;

suturing the anchor to the patient; and

removing the anchor delivery tube from the therapy delivery element; and

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