Temporary electrode connection for wireless pacing systems

• US 9,907,968 B2
• Filed: 02/12/2016
• Issued: 03/06/2018
• 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:
  US15/043,210
• Publication Number:
  US 20160158560A1
• Time in Patent Office: 753 Days
• Field of Search: 607 9
• 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 device, comprising:

a receiver-stimulator implantable in the heart of a patient using a delivery system and configured to receive controlled acoustic energy from a controller-transmitter and to convert the acoustic energy to electrical energy, the receiver-stimulator comprising;

at least two electrodes configured to deliver electrical energy;

one or more temporary electrical connection(s) between the electrode(s) and the delivery system; and

a disconnect mechanism to disconnect the temporary electrical connection;

wherein the temporary electrical connection(s) is configured to be connected to an external monitor to determine an efficiency of conversion of acoustic energy to electrical stimulation energy at the location by comparing a level of the delivered electrical energy against the acoustic energy transmitted by the controller-transmitter.

2. The device of claim 1, wherein the delivery system is a catheter-based assembly.

3. The device of claim 1 configured to stimulate the heart using the two electrodes, wherein the two electrodes are an anode and a cathode, and wherein the temporary electrical connection is between the cathode and the delivery system.

4. The device of claim 1 configured to stimulate the heart using the two electrodes, wherein the two electrodes are an anode and a cathode, and wherein the temporary electrical connection is between the anode and the delivery system.

5. The device of claim 1 configured to stimulate the heart using the two electrodes, wherein the two electrodes are an anode and a cathode, and wherein the temporary electrical connections are a first temporary electrical connection between the cathode and the delivery system and a second temporary electrical connection between the anode and the delivery system.

6. The device of claim 5, wherein the first temporary electrical connection is between a first electrical contact at a first proximal position of the receiver-stimulator and a first electrical contact at a first distal position of the delivery system assembly, and wherein the disconnect mechanism is further configured to insulate the first electrical contact at the first proximal position of the receiver-stimulator from a conductive path to the patient.

7. The device of claim 6, wherein the disconnect mechanism comprises a connector receptacle allowing a conductive wire to feed through from the delivery system assembly to the first electrical contact at the first proximal position of the receiver-stimulator, and wherein the connector receptacle is covered by a compressed seal configured to close when the conductive wire is withdrawn.

8. The device of claim 7, wherein the seal comprises silicone or rubber.

9. The device of claim 6, wherein the disconnect mechanism is further configured to electrically isolate the first electrical contact at the first proximal position of the receiver-stimulator from the cathode.

10. The device of claim 9, wherein the disconnect mechanism comprises a magnetically operated switch in the receiver-stimulator.

11. The device of claim 10, wherein the magnetically operated switch is held closed by a magnet on the distal end of the delivery system assembly, and wherein the switch is opened by one or more springs upon detaching the delivery system and disconnects the first temporary electrical connection.

12. The device of claim 10, wherein the magnetically operated switch is a reed switch held closed by a magnet on the distal end of the delivery system assembly, and wherein the reed switch opens upon detaching the delivery system and disconnects the first temporary electrical connection.

13. The device of claim 9, wherein the disconnect mechanism comprises a bellows that stretches when the delivery system is detached from the receiver-stimulator, thereby disconnecting the first temporary electrical connection.

14. The device of claim 13, wherein the bellows is held compressed while connected to the delivery system and springs open when released from the delivery system.

15. The device of claim 9, wherein the disconnect mechanism comprises a conductive dome structure that bulges outward when the delivery system is detached from the receiver-stimulator, thereby disconnecting the first temporary electrical connection.

16. The device of claim 1, wherein the disconnect mechanism comprises a fuse that is opened to disconnect the temporary electrical connection.

17. The device of claim 1, wherein the disconnect mechanism comprises an electronic switch which when activated disconnects the temporary electrical connection.

18. A catheter-based delivery system for implantation of a receiver-stimulator into the heart of a patient, comprising:

a catheter assembly having a proximal end and a distal end, the catheter assembly comprising;

a receiver-stimulator detachably attached at the distal end of the catheter assembly, the receiver-stimulator configured to convert received acoustic energy from a controller-transmitter to electrical energy, wherein said receiver-stimulator comprises a cathode and an anode, both configured to be in electrical contact with the patient for stimulating the heart;

a first temporary electrical connection between the cathode and the catheter assembly, the electrical connection extending through the catheter assembly;

a disconnect mechanism to disconnect the first temporary electrical connection; and

an indifferent electrode, the indifferent electrode in electrical contact with the patient;

wherein the cathode and the indifferent electrode are configured to monitor heart electrical activity and to stimulate the heart to determine 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.

19. The catheter-based delivery system of claim 18, wherein the system further comprises a second temporary electrical connection between the anode and the catheter assembly and the electrical connection extending through the catheter assembly, and further comprises a disconnect mechanism to disconnect the second temporary electrical connection wherein the cathode and the anode are configured to monitor heart electrical activity and to stimulate the heart.

20. The catheter-based delivery system of claim 18, wherein the indifferent electrode is disposed on the catheter assembly with an electrical connection extending through the catheter assembly.

21. The catheter-based delivery system of claim 18, wherein the indifferent electrode is remote from the delivery system.

22. A method for determining the efficiency of operation of a wireless tissue stimulation system, comprising:

transmitting energy from a controller-transmitter towards an implantable receiver-stimulator comprising a cathode stimulation electrode and an anode stimulation electrode, wherein the receiver-stimulator is configured to be mounted on a catheter assembly, and wherein the catheter assembly is configured to implant the receiver-stimulator; and

measuring electrical energy converted by the receiver-stimulator from the transmitted energy;

wherein the measuring comprises analyzing an electrogram between two temporary electrical connections connected to the two stimulation electrodes of the receiver stimulator;

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.

23. A method for determining the efficiency of operation of a wireless tissue stimulation system, comprising:

transmitting energy from a controller-transmitter towards an implantable receiver stimulator comprising a cathode stimulation electrode and an anode stimulation electrode, wherein the receiver-stimulator is configured to be mounted on a catheter assembly, and wherein the catheter assembly is configured to implant the receiver-stimulator; and

measuring electrical energy converted by the receiver-stimulator from the transmitted energy;

wherein the measuring comprises analyzing an electrogram between a temporary electrical connection connected to at least one of the two stimulation electrodes of the receiver stimulator and an indifferent electrode;

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.

24. The method of claim 23, wherein the indifferent electrode is mounted on the catheter assembly.

25. The method of claim 23, wherein the indifferent electrode is remote from the catheter assembly.