Device and method for positioning an electrode in tissue

• US 9,844,663 B2
• Filed: 05/11/2015
• Issued: 12/19/2017
• Est. Priority Date: 09/28/2010
• Status: Active Grant

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Inventors: Swaminathan, Aravind, Garai, Ellis
• Primary Examiner(s): Yabut, Diane
• Assistant Examiner(s): TON, MARTIN TRUYEN
• Application Number:
  US14/708,792
• Publication Number:
  US 20150343201A1
• Time in Patent Office: 953 Days
• 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 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook

Abstract

A device for positioning an electrode in tissue includes: a lead body having a distal portion; an electrode array coupled to the lead distal portion; an anchoring element having an anchor tip and being operable in a first configuration in which the anchor tip is retracted within the lead and in a second configuration in which the anchor tip is extended outside the lead and configured to fixate within the tissue; and a displacement mechanism that is actuated to bias the electrode array or the anchoring element toward the tissue. A method for positioning an electrode in tissue includes: navigating, to the tissue, a lead with an electrode array, an anchoring element with a distal anchor tip, and a displacement mechanism; biasing the electrode array and anchoring element towards the tissue with the displacement mechanism; and deploying the anchoring element, and verifying fixation of the anchor tip within the tissue.

Claims

1. A method for positioning an electrode in a patient'"'"'s right ventricle, said method comprising:

navigating an elongate body having a distal portion and a proximal portion to position an electrode array and at least one anchoring element carried on a side of the distal portion of the elongate body adjacent to a target tissue within the right ventricle, wherein the distal portion of the elongate body has an atraumatic tip formed from a soft, compressible material to reduce or eliminate the likelihood of perforation of the tissue as the elongate body is being navigated;

after the distal portion of the elongate body has been positioned in the right ventricle, actuating a displacement mechanism attached to a side of the distal portion of the elongate body opposite to the side which carries the electrode array and the at least one anchoring element to engage the distal portion but not the proximal portion of the elongate body against the target tissue to contact the electrode array and the at least one anchoring element against the target tissue within the right ventricle;

after actuating the displacement mechanism to engage the distal portion of the elongate body against the target tissue, deploying the at least one anchoring element on the side of the distal portion of the elongate body to affix the at least one anchoring element to the target tissue; and

after deploying the at least one anchoring element, verifying fixation of the at least one anchoring element to the target tissue.

2. The method of claim 1, wherein actuating the displacement mechanism includes expanding the displacement mechanism in a direction substantially opposite to a direction of anchoring element deployment.

3. The method of claim 2, wherein the displacement mechanism pushes against a wall within the right ventricle which opposes the target tissue.

4. The method of claim 3, wherein the target tissue is on an interventricular septum and displacement mechanism pushes against a wall opposite to the interventricular septum.

5. The method of claim 2, wherein actuating the displacement mechanism includes inflating a balloon.

6. The method of claim 5, wherein the balloon is inflated against a heart wall opposite to an interventricular septum.

7. The method of claim 1, wherein the displacement mechanism applies suction to an interventricular septum.

8. The method of claim 1, wherein verifying fixation of the at least one anchoring element to the target tissue includes releasing contrast fluid and viewing the contrast fluid flow under fluoroscopy.

9. The method of claim, 1 wherein verifying fixation of the at least one anchoring element to the target tissue includes receiving an electrical signal that signifies when the anchoring element is in the second configuration and affixed to the tissue.

10. The method of claim 1, wherein verifying fixation of the at least one anchoring element to the target tissue includes measuring impedance across distal contact points intended to be in contact with the target tissue.

11. The method of claim 1, further comprising verifying a position of the electrode array relative to the target tissue.

12. The method of claim 11, further comprising deactivating the displacement mechanism after verifying the position of the electrode array, wherein the at least one anchoring element remains affixed to the target tissue after the displacement mechanism is actuated.

13. The method of claim 1, wherein the at least one anchoring element is deployed while the displacement mechanism remains actuated and the at least one anchoring element remains in contact with the target tissue.