Mechanism, system, method for in vivo lead fixation

• US 9,919,150 B2
• Filed: 03/15/2013
• Issued: 03/20/2018
• Est. Priority Date: 03/15/2012
• Status: Active Grant

• Current Assignee: Subramaniam Chitoor Krishnan
• Original Assignee: Subramaniam Chitoor Krishnan
• Inventors: Krishnan, Subramaniam Chitoor, Patil, Nitin
• Primary Examiner(s): Tejani, Ankit D
• Application Number:
  US14/385,091
• Publication Number:
  US 20150045867A1
• Time in Patent Office: 1,831 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 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A lead for in vivo procedures for stimulation of a tissue is provided that has stimulating electrodes and a fixation mechanism disposed at a distal end of the lead. The fixation mechanism includes a fixation component disposed on an opposite side with respect to an active surface of the stimulation electrodes. The lead fixation mechanism when deployed disposes the active surface of stimulation electrodes onto a tissue region opposite to the fixation component. A system and a method for optimally positioning the lead for stimulation of the tissue are also provided.

Claims

1. A fixation mechanism for a pacing lead positioned at a distal end of the pacing lead, the pacing lead having one or more stimulation electrodes that stimulate cardiac tissue when the pacing lead is advanced into an epicardial coronary vein of a left ventricle and is configured to be surrounded by a parietal pericardium with an attached phrenic nerve on one side and a myocardium on an opposite side, the fixation mechanism comprising:

a fixation component that has an expandable portion, the expandable portion faces the parietal pericardium and is positioned on a side opposite an active surface of the one or more stimulation electrodes that faces the myocardium, wherein when the expandable portion of the fixation component expands, the expandable portion of the fixation component is configured to;

move the parietal pericardium and the attached phrenic nerve away from the one or more stimulation electrodes,

fix the active surface of the one or more stimulation electrodes onto a tissue region of the myocardium within the epicardial coronary vein; and

form an insulating barrier between the parietal pericardium and the active surface of the one or more stimulation electrodes that are fixed onto the tissue region of the myocardium within the epicardial coronary vein to insulate the attached phrenic nerve from the active surface of the one or more stimulation electrodes, the insulation barrier having an impedance that is based on a position of the fixation component within the epicardial coronary vein.

2. The fixation mechanism of claim 1, wherein the fixation component is disposed on a partial portion of a lead circumference at the distal end of the pacing lead.

3. The fixation mechanism of claim 1, wherein the fixation component is composed of at least one of a biocompatible sponge, polymer tines, self expanding nitinol structure, a hydrogel and combinations thereof.

4. The fixation mechanism of claim 1, wherein the fixation component is covered by a retractable polymer sheath, and wherein the fixation component is deployed by retracting the polymer sheath.

5. The fixation mechanism of claim 1, wherein the fixation component is coated with a bio adhesive material that creates one or more spines to provide adhesion of the pacing lead in a desired location.

6. The fixation mechanism of claim 5, wherein the bio adhesive material is at least one of starch, cellulose, talc, or combinations thereof.

7. The fixation mechanism of claim 3, wherein the biocompatible sponge is covered by a dissolvable film.

8. The fixation mechanism of claim 1, wherein the one or more stimulation electrodes are at least one of semi-circular ring, quadrant, or fully circular rings.

9. The fixation mechanism of claim 1, wherein the one or more stimulation electrodes are formed by selectively metalizing a polymer surface to provide the active surface of the one or more stimulation electrodes.

10. The fixation mechanism of claim 1, further comprising radio opaque markers positioned on the pacing lead to identify an orientation of the fixation component with respect to the tissue region.

11. The fixation mechanism of claim 1, further comprising a locking key mechanism to avoid rotation of the pacing lead.

12. The fixation mechanism of claim 1, wherein the fixation component expands at a fixing location to form the insulating barrier between the active surface of the one or more stimulation electrodes and the parietal pericardium.

13. The fixation mechanism of claim 1, wherein the fixation component expands and does not perforate a cardiac vessel wall to provide access for the pacing lead into a pericardial cavity in a region of the parietal pericardium.

14. The fixation mechanism of claim 1, wherein the one or more stimulation electrodes are only positioned on a side that faces the myocardium.

15. The fixation mechanism of claim 1, wherein the pacing lead is configured to control the impedance of the insulating barrier by rotating and positioning the active surface of the one or more stimulation electrodes to face the myocardium and positioning the fixation component to face the parietal pericardium with the attached phrenic nerve.

16. The fixation mechanism of claim 1, wherein the fixation component expands within a circumference of the epicardial coronary vein.

17. The fixation mechanism of claim 1, wherein the fixation component is made of a plastic or polyurethane lobe that is configured to be expandable and to fix the pacing lead in a particular position.