HIS BUNDLE LEAD DELIVERY SYSTEM

• US 20140067036A1
• Filed: 08/29/2013
• Published: 03/06/2014
• 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
• Granted Patent: US 9,579,501 B2
• Time in Patent Office: Days
• US Class Current: 607/126
• 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 system for delivering a lead to a target site, the system comprising:

an outer guide catheter having a proximal end, a distal end having a distal tip, a lumen having an opening at the distal tip, and a preformed curve in the distal end of the outer guide catheter;

an inner guide catheter having a proximal end, a distal end having a distal tip, a lumen having an opening at the distal tip, at least one electrode, and at least one conductor in electrical connection with the electrode and extending to the proximal end, the inner guide catheter moveable within the lumen of the outer guide catheter and extendable from the opening of the lumen at the distal tip 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 moveable within the lumen of the inner guide catheter and extendable from the opening of the lumen at the distal tip of the inner guide catheter, the anchor wire flexible, the fixation element configured to penetrate tissue of the target site to anchor the anchor wire to the tissue of the target site; and

an implantable lead having a proximal end configured to interface with an implantable pulse generator, a distal end, at least one electrode on the distal end of the implantable lead, at least one conductor electrically connected to the at least one electrode and extending to the proximal end of the implantable lead, and a lumen sized to accommodate the anchor wire, the implantable lead flexible and configured to be advanced over the anchor wire to bring the at least one electrode of the implantable lead in contact with the target site while the anchor wire is anchored to the tissue of the target site and the anchor wire extends within the lumen of the implantable lead.

2. The system of claim 1, wherein the target site is the bundle of His, below the tricuspid valve, within the right ventricle.

3. The lead system of claim 1, wherein the curve in the distal end of the outer guide catheter is between 150 and 210 degrees.

4. The lead system of claim 1, wherein the inner guide catheter comprises a curve along a distal end.

5. The lead system of claim 4, wherein the curve of the outer guide catheter is rotatable about a first axis of the outer guide catheter and the curve of the inner guide catheter is rotatable relative to the outer guide catheter about a second axis when the curve of the inner guide catheter extends beyond the opening of the lumen at the distal tip of the outer guide catheter, the first axis not parallel with the second axis.

6. The lead system of claim 1, wherein the implantable lead further comprises a fixation element configured to penetrate the tissue of the target site and anchor the implantable lead to the tissue of the target site.

7. The lead system of claim 6, wherein:

the fixation element of the anchor wire is a first helix;

the fixation element of the implantable lead is a second helix with lumen; and

the first helix and the second helix are sized such that the first helix can be moved through the lumen of the second helix.

8. The lead system of claim 1, wherein the anchor wire comprises:

a conductor extending from the proximal end to the distal end of the anchor wire; and

an electrical insulator that insulates the conductor from the proximal end to the distal end of the anchor wire, the fixation element electrically connected to the conductor and exposed to one or both of receive electrical energy from, and deliver electrical energy to, the tissue of the target site.

9. The lead system of claim 1, wherein the outer guide catheter comprises an electrode on an exterior surface of the outer guide catheter along the curve of the outer guide catheter.

10. The lead system of claim 1, wherein the electrode of the inner guide catheter and the fixation element of the anchor wire are electrically connected to circuitry configured to sense a biomarker signal from the bundle of His with the electrode and the fixation element as a bipolar sensing pair.

11. 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; and

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 area immediately below the tricuspid valve in the right ventricle extending 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.

12. The lead delivery system of claim 11, 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.

13. The lead delivery system of claim 11, further comprising 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.

14. The lead delivery system of claim 13, 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 area.

15. The lead delivery system of claim 13, 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.

16. 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;

anchoring the anchor wire to target tissue within the right ventricle by engaging the fixation element with the tissue, the target tissue immediately below the tricuspid valve in the right ventricle and extending about 15 millimeters down the septal wall proximate the bundle of His; 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.

17. The method of claim 16, further comprising locating the target site by sensing a biomarker indicative of the bundle of His with an electrode on the distal tip of the inner guide catheter.

18. The method of claim 17, wherein locating the target site further comprises sensing the biomarker by receiving a signal indicative of the biomarker through the fixation element, the biomarker sensed by the fixation element of the anchor wire and the electrode of the inner guide catheter as a bipolar pair.

19. The method of claim 16, 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.

20. The method of claim 16, 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.

21-24. -24. (canceled)