TEMPORARY ELECTRODE CONNECTION FOR WIRELESS PACING SYSTEMS

• US 20110237967A1
• Filed: 09/24/2010
• Published: 09/29/2011
• Est. Priority Date: 03/25/2008
• Status: Active Grant

• Current Assignee: EBR Systems, Inc.
• Original Assignee: EBR Systems, Inc.
• Inventors: Cowan, Mark W., Willis, N. Parker, Moore, David F.
• Granted Patent: US 9,283,392 B2
• Time in Patent Office: Days
• US Class Current: 600/509
• 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 energy from a controller-transmitter, the receiver-stimulator comprising;

at least two electrodes;

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.

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

3. The device of claim 1, wherein the receiver-stimulator is configured to receive controlled acoustic energy from a controller-transmitter.

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 cathode 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 connection is between the anode and the delivery system.

6. 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.

7. The device of claim 6, 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.

8. The device of claim 7, 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.

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

10. The device of claim 7, 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.

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

12. The device of claim 11, 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.

13. The device of claim 11, 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.

14. The device of claim 10, 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.

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

16. The device of claim 10, 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.

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

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

19. 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 comprising 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.

20. The catheter-based delivery system of claim 19, 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.

21. The catheter-based delivery system of claim 19, wherein the indifferent electrode is disposed on the catheter assembly with an electrical connection extending through the catheter assembly.

22. The catheter-based delivery system of claim 19, wherein the indifferent electrode is remote from the delivery system.

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

positioning a delivery system with a receiver-stimulator disposed at a distal end of the delivery system at a location in a patient'"'"'s heart, wherein the receiver-stimulator is implantable in the heart and configured to receive controlled energy from a controller-transmitter, the receiver-stimulator comprising a cathode and an anode for stimulating the heart and a first temporary electrical connection to the cathode routed through the delivery system to an external monitor;

monitoring the heart'"'"'s electrical activity using an external monitor; and

determining whether the location indicates excitable heart tissue.

24. The method of claim 23, wherein the receiver-stimulator further comprises a second temporary electrical connection to the anode routed through the delivery system to the external monitor, and the monitoring is done with the first and second temporary electrical connections.

25. The method of claim 23, wherein the monitoring is done with the first temporary electrical connection to the cathode and an indifferent electrode in electrical contact with the patient.

26. The method of claim 25, wherein indifferent electrode is disposed on the delivery system.

27. The method of claim 25, wherein indifferent electrode is remote form the delivery system.

28. The method of claim 23, wherein the delivery system is a catheter-based delivery system.

29. The method of claim 24, further comprising:

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

30. The method of claim 25, further comprising:

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

31. The method of claim 30, wherein the indifferent electrode is disposed on the delivery system.

32. The method of claim 30, wherein the indifferent electrode is remote form the delivery system.

33. The method of claim 29, further comprising:

determining an acceptable pacing threshold at the location.

34. The method of claim 33, further comprising:

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

35. The method of claim 34, wherein the implanting further comprises:

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

36. The method of claim 23, wherein the receiver-stimulator is configured to receive controlled acoustic energy from a controller-transmitter.

37. The method of claim 36, further comprising:

delivering acoustic energy from the controller-transmitter to the receiver-stimulator, wherein the stimulating the heart tissue comprises using electrical stimulation energy converted by the receiver-stimulator from the acoustic energy; and

determining the efficiency of conversion of acoustic energy to electrical stimulation energy at the location that is determined to be excitable.

38. The method of claim 37, further comprising:

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

39. The method of claim 38, wherein the implanting comprises:

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

40. 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.

41. The method of claim 40, wherein the transmitted energy is acoustic energy.

42. 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.

43. The method of claim 42, wherein the transmitted energy is acoustic energy.

44. The method of claim 42, wherein the indifferent electrode is mounted on the catheter assembly.

45. The method of claim 42, wherein the indifferent electrode is remote from the catheter assembly.