His bundle lead delivery system

• US 9,579,501 B2
• Filed: 08/29/2013
• Issued: 02/28/2017
• Est. Priority Date: 08/30/2012
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Shuros, Allan C., Tockman, Bruce A., Reddy, G. Shantanu
• Primary Examiner(s): Hankins, Lindsey G
• Application Number:
  US14/014,007
• Publication Number:
  US 20140067036A1
• Time in Patent Office: 1,279 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0565 Electrode heads
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators

Abstract

Various embodiments concern implanting a lead to directly stimulate the bundle of His. Various embodiments can include introducing a curve of an outer guide catheter into the right ventricle, extending a curve of an inner guide catheter from a lumen of the outer guide catheter, extending a fixation element on a distal tip of an anchor wire from a lumen the inner guide catheter, and anchoring the anchor wire to target tissue within the right ventricle, the target tissue along the septal wall and proximate the tricuspid valve and the bundle of His. A distal tip of an implantable lead with a lumen can then be advanced over the anchor wire to the target tissue as the anchor wire guides the distal tip of the lead to the target tissue.

Claims

1. A lead delivery system for delivering a lead to the bundle of His from below the tricuspid valve in the right ventricle, the delivery system comprising:

an outer guide catheter having a proximal end, a distal end, a distal tip, a lumen having an opening at the distal tip of the outer guide catheter, and a preformed curve in the distal end of the outer guide catheter, the curve in the distal end of the outer guide catheter approximately 180 degrees, the outer guide catheter configured to be introduced transvascularly and extend down the superior vena cava and position the curve of the outer guide catheter within the right ventricle;

an inner guide catheter having a proximal end, a distal end, a lumen having a opening on the distal end, at least one electrode on the distal end, at least one conductor extending from the electrode to the proximal end, and a curve in the distal end, the inner guide catheter moveable within the lumen of the outer guide catheter and extendable from the opening of the outer guide catheter, the curve in the distal end of the inner guide catheter dimensioned to point the opening of the lumen of the inner guide catheter at a target site in an area extending from immediately below the tricuspid valve in the right ventricle to about 15 millimeters down the septal wall proximate the bundle of His when the curve of the outer guide catheter is within the right ventricle and the curve of the inner guide catheter is extended out of the lumen of the outer guide catheter;

an anchor wire having a proximal end, a distal end, and a fixation element on the distal end of the anchor wire, the anchor wire flexible and moveable within the lumen of the inner guide catheter and extendable from the opening of the inner guide catheter, the fixation element configured to penetrate tissue of the target site to anchor the anchor wire to the tissue of the target site,

wherein the electrode of the inner guide catheter and the fixation element of the anchor wire are electrically connected to a circuit configured to sense a biomarker signal from the bundle of His with the electrode and the fixation element as a bipolar sensing pair.

2. The lead delivery system of claim 1, wherein:

the outer guide catheter can be rotated at the proximal end to rotate the curve in the distal end of the outer guide catheter about a central axis of the outer guide catheter; and

the inner guide catheter is rotatable relative to the outer guide catheter when the curve in the distal end of the inner guide catheter extends past the opening of the outer guide catheter, the curve of the inner guide catheter rotatable along an axis that is not parallel to the central axis of the outer guide catheter.

3. The lead delivery system of claim 1, further comprising an implantable lead having a lumen, the anchor wire and the lumen dimensioned such that the implantable lead can be advanced over the anchor wire to the target site.

4. A method of implanting a lead to stimulate the bundle of His, the method comprising:

introducing at least a curve of an outer guide catheter into a right ventricle, the outer guide catheter having a lumen with an opening at a distal tip of the outer guide catheter;

extending a curve of an inner guide catheter from the opening of the lumen at the distal tip of the outer guide catheter, the inner guide catheter moveable within the lumen of the outer guide catheter and having a lumen with an opening at a distal tip of the inner guide catheter;

extending a fixation element on a distal tip of an anchor wire from the opening on the distal tip of the inner guide catheter, the anchor wire flexible and moveable within the lumen of the inner guide catheter;

locating tissue of a target site by sensing a biomarker indicative of the bundle of His, the biomarker sensed by the fixation element of the anchor wire and an electrode on the distal tip of the inner guide catheter as a bipolar pair, the target tissue extending from immediately below the tricuspid valve in the right ventricle to about 15 millimeters down the septal wall proximate the bundle of His;

anchoring the anchor wire to target tissue within the right ventricle by engaging the fixation element with the tissue; and

advancing a distal tip of an implantable lead over the anchor wire to the target tissue, the implantable lead having a lumen, the anchor wire within the lumen of the implantable lead during the advancement of the implantable lead.

5. The method of claim 4, further comprising removing the outer guide catheter and the inner guide catheter from over the anchor wire while leaving the anchor wire attached to the target tissue before advancing the implantable lead over the anchor wire to the target tissue.

6. The method of claim 4, further comprising rotating the inner guide catheter relative to the outer guide catheter when the curve of the inner guide catheter extends from the opening of the lumen at the distal tip of the outer guide catheter to bring the distal tip of the inner guide catheter in contact with the target tissue.