Lead anchor for implantable devices and methods of manufacture and use

• US 9,320,891 B2
• Filed: 04/01/2009
• Issued: 04/26/2016
• Est. Priority Date: 04/02/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Anderson, Meredith L., Howard, Joshua D., Phillips, Matthew J.
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US12/416,801
• Publication Number:
  US 20090254151A1
• Time in Patent Office: 2,582 Days
• Field of Search: 607/116, 606/232
• US Class Current: 1/1
• 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 1/057 Anchoring means; Means for fixing the head inside the heart

Abstract

A lead anchor includes a body with opposing first and second major surfaces and at least one edge surface between the first and second major surfaces. The body defines a first channel, a second channel, and a notch. The first channel extends from the edge surface of the body and is open at the first major surface. The second channel extends from the edge surface of the body and is open at the second major surface. The notch extends from the edge surface of the body, defines an opening from the first major surface through the body to the second major surface, and intersects the first channel and the second channel. The first channel, the second channel, and a portion of the notch define a passage through the body so that a lead can be inserted into the notch and turned to dispose a portion of the lead within the passage. The lead anchor can be part of a kit or system that also includes a lead.

Claims

1. A lead anchor comprising:

a body having opposing first and second major surfaces and at least one edge surface between the first and second major surfaces, the body defining a first lead channel, a second lead channel, and a notch wherein

the first lead channel extends from the edge surface of the body and is open at the first major surface;

the second lead channel extends from the edge surface of the body and is open at the second major surface;

the notch extends from the edge surface of the body, defines an opening from the first major surface through the body to the second major surface, and intersects the first lead channel and the second lead channel; and

the first lead channel, the second lead channel, and a portion of the notch define a passage through the body wherein the body is configured and arranged so that a lead can be inserted into the notch and turned to dispose a portion of the lead within the passage with the lead extending along the first lead channel and along the second lead channel.

2. The lead anchor of claim 1, further comprising at least one retention feature disposed within the first lead channel, the second lead channel or both the first lead channel and the second lead channel.

3. The lead anchor of claim 2, wherein the at least one retention feature comprises a parallel retention feature with a ridge that is configured and arranged to run substantially parallel to the portion of the lead disposed in the first or second lead channel within which the parallel retention feature is disposed.

4. The lead anchor of claim 2, wherein the at least one retention feature comprises a perpendicular retention feature with a ridge that is configured and arranged to run substantially perpendicular to the portion of the lead disposed in the first or second lead channel within which the perpendicular retention feature is disposed.

5. The lead anchor of claim 2, wherein the at least one retention feature comprises a uni-directional retention feature with a peak that is configured and arranged to run substantially perpendicular to the portion of the lead disposed in the first or second lead channel within which the uni-directional retention feature is disposed, wherein the peak is oriented to prevent or reduce axial movement of the portion of the lead toward a center of the lead anchor.

6. The lead anchor of claim 2, wherein the at least one retention feature comprises a plurality of retention features with peaks that are configured and arranged to run substantially perpendicular to the portion of the lead disposed in the first or second lead channel within which the retention feature is disposed, wherein the peaks are oriented to provide bi-directional retention to prevent or reduce axial movement of the portion of the lead both toward and away from a center of the lead anchor.

7. The lead anchor of claim 2, wherein the at least one retention feature comprises a retention feature disposed within the second lead channel and a retention feature disposed within the first lead channel.

8. The lead anchor of claim 2, wherein the at least one retention feature comprises a first retention feature and a second retention feature, wherein the first retention feature is disposed within the first lead channel and has a peak oriented in an opposite direction to a peak of the second retention feature which is disposed within the second lead channel.

9. The lead anchor of claim 1, further comprising at least one suture opening.

10. The lead anchor of claim 1, wherein at least one end of the body is tapered.

11. The lead anchor of claim 1, wherein the body has a rounded edge at a lead insertion site.

12. The lead anchor of claim 1, further comprising a gate feature disposed in the notch, the gate feature extending away from a remainder of the lead anchor and into the notch and configured and arranged to prevent the lead from being released from the lead anchor.

13. The lead anchor of claim 9, further comprising an extension, wherein the at least one suture opening is disposed on the extension.

14. The lead anchor of claim 1, wherein the body comprises a radiopaque material.

15. The lead anchor of claim 1, wherein the passage through the body formed by the first lead channel, the second lead channel and a portion of the notch is non-linear.

16. A kit comprising:

a lead; and

the lead anchor of claim 1.

17. A system for stimulation comprising:

a control module;

a lead comprising an array of electrodes coupled to the control module; and

at least one lead anchor that may be disposed around a portion of the lead, wherein the lead anchor comprises

a body having opposing first and second major surfaces and at least one edge surface between the first and second major surfaces, the body defining a first lead channel, a second lead channel, and a notch wherein

the first lead channel extends from the edge surface of the body and is open at the first major surface;

the second lead channel extends from the edge surface of the body and is open at the second major surface;

the notch extends from the edge surface of the body, defines an opening from the first major surface through the body to the second major surface, and intersects the first lead channel and the second lead channel; and

the first lead channel, the second lead channel, and a portion of the notch define a passage through the body wherein the body is configured and arranged so that a lead can be inserted into the notch and turned to dispose a portion of the lead within the passage with the lead extending along the first lead channel and along the second lead channel.

18. A method of implanting a stimulation device, the method comprising:

inserting a lead in a notch in a body of a lead anchor; and

turning the lead to dispose a portion of the lead within a first lead channel and a second lead channel, wherein the first and second lead channels extend from the notch to an edge surface of the body;

the first lead channel is open from a first major surface of the body; and

the second lead channel is open from a second major surface of the body, the second major surface being opposite the first major surface.

19. The method of implanting a stimulation device of claim 18, further comprising sliding the lead anchor along the lead until it has been placed in the desired location after inserting the lead in the notch and before turning the lead to dispose a portion of the lead within the passage.

20. The method of implanting a stimulation device of claim 18, wherein inserting a lead in a notch in a body of a lead anchor comprises inserting a portion of the lead between a proximal end and a distal end of the lead in the notch.