Temporary electrode connection for wireless pacing systems

• US 9,283,392 B2
• Filed: 09/24/2010
• Issued: 03/15/2016
• Est. Priority Date: 03/25/2008
• Status: Active Grant

• Current Assignee: EBR Systems, Inc.
• Original Assignee: EBR Systems, Inc.
• Inventors: Moore, David F., Cowan, Mark W., Willis, N. Parker
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US12/890,308
• Publication Number:
  US 20110237967A1
• Time in Patent Office: 1,999 Days
• Field of Search: 607/9, 607/17, 607/28, 607/2, 600/509, 600/471, 606/129, 606/101, 606/38
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/29 for permanent or long-term implantation
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Delivery of an implantable wireless receiver-stimulator (R-S) into the heart using delivery catheter is described. R-S comprises a cathode and an anode and wirelessly receives and converts energy, such as acoustic ultrasound energy, to electrical energy to stimulate the heart. Conductive wires routed through the delivery system temporarily connect R-S electrodes to external monitor and pacing controller. R-S comprises a first temporary electrical connection from the catheter to the cathode, and a second temporary electrical connection from the catheter to the anode. Temporary electrical connections allow external monitoring of heart'"'"'s electrical activity as sensed by R-S electrodes to determine tissue viability for excitation as well as to assess energy conversion efficiency.

Claims

1. A method for determining whether tissue is excitable, comprising:

positioning a delivery system with an implantable and detachable receiver-stimulator attached to a distal end of the delivery system at a location in a patient'"'"'s heart, wherein the receiver-stimulator comprises a cathode and an anode for stimulating the heart and a first detachable temporary electrical connection between the cathode and the distal end of the delivery system, wherein the first temporary electrical connection provides a first conductive path from the cathode to an external monitor via a first conductive wire routed through the delivery system;

transmitting acoustic energy from a controller-transmitter to the receiver-stimulator;

converting the acoustic energy to electrical energy by the receiver-stimulator;

stimulating the heart using the receiver-stimulator at the location in the patient'"'"'s heart by delivering electrical energy to the heart;

determining a likelihood of pacing based on the excitability of the heart tissue by monitoring the electrical activity using the external monitor;

quantifying the delivered electrical energy by using the external monitor;

determining an efficiency of conversion of acoustic energy to electrical stimulation energy at the location that is determined to be excitable by comparing a level of the delivered electrical energy against the acoustic energy transmitted by the controller-transmitter; and

correlating the efficiency of conversion with the likelihood of pacing of the heart issue;

wherein the controller-transmitter is separate from the receiver-stimulator and the external monitor.

2. The method of claim 1, wherein the stimulating the heart tissue comprises using electrical stimulation energy converted by the receive-stimulator from the acoustic energy.

3. The method of claim 2, further comprising:

detaching the receiver-stimulator from the delivery system; and

implanting the receiver-stimulator into the heart at the implantation site when the efficiency of acoustic energy conversion to electrical stimulation energy is determined to be acceptable.

4. The method of claim 3, wherein the detaching comprises:

activating a mechanism to disconnect at least the first temporary electrical connection.

5. The method of claim 1, wherein the delivery system is a catheter-based delivery system.

6. The method of claim 1, wherein the receiver-stimulator further comprises a second detachable temporary electrical connection between the anode and the distal end of the delivery system, wherein the second temporary electrical connection provides a second conductive path from the anode to the external monitor via a second conductive wire routed through the delivery system, and the monitoring is done with the first and second temporary electrical connections.

7. The method of claim 6, wherein the external monitor is an external pacing controller, the method further comprising:

stimulating the heart tissue using electrical stimulation energy from the external pacing controller delivered to the tissue through the cathode and the anode.

8. The method of claim 7, further comprising:

determining an acceptable pacing threshold at the location.

9. The method of claim 8, further comprising:

detaching the receiver-stimulator from the delivery system; and

implanting the receiver-stimulator into the heart at the location where the pacing threshold has been determined to be acceptable.

10. The method of claim 9, wherein the detaching further comprises:

activating a mechanism to disconnect at least the first temporary electrical connection.

11. The method of claim 1, wherein the monitoring is done with the first temporary electrical connection to the cathode and an indifferent electrode in electrical contact with the patient, wherein the indifferent electrode is remote from the receiver-stimulator.

12. The method of claim 11, wherein the indifferent electrode is disposed on the delivery system.

13. The method of claim 11, wherein the indifferent electrode is remote from the delivery system.

14. The method of claim 11, wherein the external monitor is an external pacing controller, the method further comprising:

stimulating the heart tissue using electrical stimulation energy from the external pacing controller delivered to the tissue through the cathode and the indifferent electrode.

15. The method of claim 14, wherein the indifferent electrode is disposed on the delivery system.

16. The method of claim 14, wherein the indifferent electrode is remote form the delivery system.