Lead anchors and systems and methods employing the lead anchors

• US 9,517,334 B2
• Filed: 08/12/2014
• Issued: 12/13/2016
• Est. Priority Date: 08/19/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Barner, Paul Keith, Howard, Joshua Dale
• Primary Examiner(s): Lee, Erica
• Application Number:
  US14/457,602
• Publication Number:
  US 20150051674A1
• Time in Patent Office: 854 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 2001/0582 Suture sleeves

Abstract

A lead anchor including a body having a first end and a second end opposite to the first end is disclosed. The body defines a lead lumen extending from the first to the second end and can receive a lead. The lead anchor also includes a fastening mechanism disposed in the body and in communication with the lead lumen. The fastening mechanism can fasten the received lead to the lead anchor when actuated by a user. The lead anchor also includes tabs(s) extending from the body and tags. Each tag includes an anchor attachment element and a cylindrical implantation element coupled to the anchor attachment element. The anchor attachment element is affixed to one of the tabs. The cylindrical implantation element anchors the lead anchor into patient tissue by insertion of the implantation element into the patient tissue using a needle insertion tool.

Claims

1. A lead anchor comprising:

a body having a first end and a second end opposite to the first end, the body defining a lead lumen extending from the first end to the second end and configured and arranged to receive a lead;

a fastening mechanism disposed in the body and in communication with the lead lumen and actuable by a user, the fastening mechanism configured and arranged for fastening the received lead to the lead anchor when actuated by the user;

a plurality of tabs extending from the body; and

a plurality of anchoring tags, each anchoring tag comprising an anchor attachment element and a cylindrical implantation element coupled to the anchor attachment element, wherein the anchor attachment element is directly fixed to, with a portion molded within, one of the tabs of the lead anchor and the cylindrical implantation element is configured and arranged to anchor the lead anchor into patient tissue by insertion of the implantation element into the patient tissue using a needle insertion tool.

2. The lead anchor of claim 1, wherein the plurality of tabs comprises a first tab extending from the body in a first direction and a second tab extending from the body in a second direction opposite from the first direction and wherein the plurality of anchoring tags comprises a first tag affixed to the first tab and a second tag affixed to the second tab.

3. The lead anchor of claim 2, wherein the cylindrical implantation elements of the first and second tags are angled to permit sequential insertion using a same needle insertion tool.

4. The lead anchor of claim 1, wherein the plurality of tabs comprises a first tab and a second tab extending from the body opposite the first tab.

5. The lead anchor of claim 4, wherein the plurality of anchoring tags comprise a first anchoring tag and a second anchoring tag, wherein a portion of the anchor attachment element of the first anchoring tag extends into and through the first tab and a portion of the anchor attachment element of the second anchoring tag extends into and through the second tab.

6. The lead anchor of claim 1, wherein the anchor attachment element of each anchoring tab is made of metal.

7. The lead anchor of claim 1, wherein the body comprises a transverse lumen in communication with the lead lumen and the fastening mechanism comprises a fastener disposed in the transverse lumen and configured and arranged for engaging the lead directly or indirectly for fastening the lead to the lead anchor.

8. The lead anchor of claim 7, wherein the fastener is a set screw.

9. The lead anchor of claim 1, wherein each anchor attachment element comprises a U-shaped portion extending out of a one of the tabs.

10. The lead anchor of claim 9, wherein each anchor attachment element defines a suture opening through which a suture can pass, wherein the suture opening is disposed between the U-shaped portion and the one of the tabs to which the anchor attachment element is fixed.

11. The lead anchor of claim 1, wherein the lead anchor comprises a same number of tabs and anchoring tags.

12. A method of anchoring a lead, the method comprising:

inserting a portion of an electrical stimulation lead into the lead anchor claim 1;

fastening the lead anchor to the portion of the lead using the fastening mechanism of the lead anchor;

loading one or more of the cylindrical implantation elements into a needle insertion tool;

delivering the one or more the cylindrical implantation elements into patient tissue using the needle insertion tool; and

releasing the one or more of the cylindrical implantation elements within the patient tissue to anchor the lead anchor and lead to the patient tissue.

13. The method of claim 12, wherein each anchor attachment element defines a suture opening through which a suture can pass;

and

the method further comprises suturing the lead anchor to the patient tissue using a suture that passes through the suture opening of the anchor attachment element of at least one of the anchoring tags.

14. A kit, comprising:

the lead anchor of claim 1; and

an implantable electrical stimulation lead coupleable to the lead anchor.

15. The kit of claim 14, further comprising a needle insertion tool for implanting the cylindrical implantation elements of the lead anchor.

16. A lead anchor comprising:

a body having a first end and a second end opposite to the first end, the body defining a lead lumen extending from the first end to the second end and configured and arranged to receive a lead;

a fastening mechanism disposed in the body and in communication with the lead lumen and actuable by a user, the fastening mechanism configured and arranged for fastening the received lead to the lead anchor when actuated by the user;

a plurality of tabs extending from the body, wherein one of the tabs includes a first surface and an opposing second surface; and

a plurality of anchoring tags, each anchoring tag comprising an anchor attachment element and a cylindrical implantation element coupled to the anchor attachment element,

wherein the anchor attachment element includes a first portion, an intermediate portion, and a second portion, the first portion extending from the first surface and coupled to the cylindrical implantation element, the intermediate portion is directly fixed to and embedded within one of the tabs, and the second portion extending from the opposing second surface, the second portion defining a suture opening through which a suture can pass, and wherein the cylindrical implantation element is configured and arranged to anchor the lead anchor into patient tissue.

17. The lead anchor of claim 16, wherein the anchor attachment element is rigid.

18. The lead anchor of claim 16, wherein the anchor attachment element includes at least one leg portion embedded within the tab.

19. The lead anchor of claim 16, wherein the at least one leg portion is rigid.