Medical lead anchoring

• US 9,764,127 B2
• Filed: 12/18/2015
• Issued: 09/19/2017
• Est. Priority Date: 12/19/2014
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Gordon, Jack, Foster, Arthur J.
• Primary Examiner(s): Lee, Erica
• Application Number:
  US14/975,678
• Publication Number:
  US 20160175581A1
• Time in Patent Office: 641 Days
• Field of Search: None
• 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
• CPC Class Codes: A61N 1/059 Anchoring means

Abstract

Various embodiments concern a lead system for anchoring a lead, the lead system comprising a lead and an anchor. The anchor can comprise a ring and a flange extending from the ring. The anchor can be mounted on the lead such that the lead extends through the ring and the flange extends over an electrode of the lead. The lead system can further comprise a tether having a proximal portion and a distal portion. The proximal portion of the tether can attached to the lead while the distal portion of the tether can be attached to a needle. During an implantation procedure, the tether can be cut to remove the needle. The tether can then be attached to the flange. The lead, the anchor, and the tether can form a loop around a section of tissue to anchor the lead to the tissue.

Claims

1. A lead system comprising:

an implantable lead, the lead comprising a proximal portion, a distal portion, a distal tip located on the distal portion, and at least one electrode located on the distal portion proximal of the distal tip;

an anchor, the anchor comprising a ring and a flange extending from the ring, the ring comprising a lumen, the anchor configured to be mounted on the lead such that the lead extends through the lumen while the ring is located proximally of the at least one electrode and the flange extends distally of the distal tip; and

a flexible tether having a proximal portion and a distal portion, the tether attached to the lead, the proximal portion of the tether extending from the distal tip of the lead, wherein the anchor is configured to anchor the lead to tissue when mounted on the lead and attached to the tether, wherein the lead, the anchor, and the tether are configured to form a loop that surrounds a section of tissue to anchor the lead to the tissue.

2. The lead system of claim 1, wherein the flange further comprises a hole, and wherein the anchor is configured to attach to the tether at least in part by the tether extending through the hole.

3. The lead system of claim 1, further comprising a needle, the needle comprising a proximal portion that is attached to the distal portion of the tether.

4. The lead system of claim 3, wherein the flange, the needle, and the electrode each have a length, the length of the flange being longer than the length of the needle, and the length of the needle being longer than the length of the at least one electrode along the lead.

5. The lead system of claim 1, wherein the ring is slidable over the proximal portion and the distal portion of the lead.

6. The lead system of claim 1, wherein the ring has a groove extending around the ring and the groove is configured to receive a suture to attach the ring to the lead.

7. The lead system of claim 1, wherein the at least one electrode comprises multiple electrodes.

8. The lead system of claim 1, wherein the flange and the lead each have a width, and the width of the flange is narrower than the width of the lead.

9. A lead system comprising:

an implantable lead, the lead comprising a proximal portion, a distal portion, and at least one electrode located on the distal portion;

an anchor, the anchor comprising a ring and a flange extending from the ring, the ring comprising a lumen, the anchor configured to be mounted on the lead such that the lead extends through the lumen while the ring is located proximally of the at least one electrode and the flange extends distal of the at least one electrode; and

a tether having a proximal portion and a distal portion, the proximal portion of the tether attached to the distal portion of the lead, the tether configured to attach to the flange, wherein the lead, the anchor, and the tether are configured to form a loop that surrounds a section of tissue to anchor the lead to the tissue.

10. A method of anchoring an implantable lead to tissue with an anchor, the lead comprising a distal portion, a distal tip located on the distal portion, at least one electrode located on the distal portion proximal of the distal tip, and a tether extending from the distal tip, the anchor comprising a ring and a flange extending from the ring, the method comprising:

embedding the at least one electrode in the tissue;

sliding the ring in the distal direction over the lead such that the ring is located proximally of the least one electrode and positioning the anchor such that the flange extends distally of the distal tip; and

attaching the tether to a distal portion of the flange, wherein a section of the tissue is surrounded by a loop formed by the lead, the anchor, and the tether to anchor the lead to the tissue.

11. The method of claim 10, wherein the lead further comprises a needle having a proximal portion, the proximal portion of the needle attached to a distal portion of the tether, and wherein embedding the at least one electrode in the tissue comprises:

forming a tunnel through the tissue with the needle;

pulling the needle out of the tunnel while stringing the tether along the tunnel;

pulling the tether through the tunnel while stringing the lead along the tunnel; and

cutting the tether while the at least one electrode is within the tunnel.

12. The method of claim 11, wherein cutting the tether further includes leaving a portion of the tether attached to the lead, and wherein attaching the tether to the distal portion of the flange comprises tying a knot in the portion of the tether.

13. The method of claim 10, wherein attaching the tether to the distal portion of the flange comprises extending the tether through a hole in the distal portion of the flange.

14. The method of claim 10, further comprising wrapping a suture around the ring to attach the ring to the tissue.

15. The method of claim 10, further comprising:

sensing at least one bioelectrical signal with the at least one electrode while the at least one electrode is within the tunnel; and

based on the at least one bioelectrical signal, moving the at least one electrode within the tunnel one or both of proximally by pulling on the lead and distally by pulling on the tether.

16. The method of claim 10, further comprising cutting away an excess portion of the flange based on a length of the tunnel.

17. The method of claim 10, wherein an interface between the ring and the lead inhibits distal movement of the at least one electrode within the tunnel, and wherein the attachment of the tether to the distal portion of the flange inhibits proximal movement of the at least one electrode within the tunnel.