Micro-charge ICD lead testing method and apparatus

• US 10,252,069 B1
• Filed: 11/21/2016
• Issued: 04/09/2019
• Est. Priority Date: 11/19/2015
• Status: Active Grant

• Current Assignee: Lambda Nu Technology LLC
• Original Assignee: Lambda Nu Technology LLC
• Inventors: Kroll, Mark W.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US15/356,962
• Time in Patent Office: 869 Days
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 2001/083 Monitoring integrity of contacts, e.g. by impedance measurement

Abstract

Systems and methods for detecting lead anomalies by detecting overcurrent conditions caused by the delivery of high voltage test pulses configured to minimize patient sensation. Patient sensation is minimized by limiting the total charge delivered in either a positive or negative test pulse by limiting duration, and/or by cancelling nerve activations by delivery of an opposite phase cancellation pulse as part of a biphasic test pulse. Embodiments include high-speed H-bridge switches, and micro-coulomb test capacitors to control total charge and duration. Embodiments detect anomalies when an overcurrent circuit detects a current above a threshold passing through an electrode that is not directly energized.

Claims

1. An implantable cardioverter defibrillator electrically connected to at least two defibrillation electrodes, at least one of the at least two defibrillation electrodes being located remotely from the defibrillator along a lead, the defibrillator comprising:

at least one high voltage transformer electrically connected between a battery and at least one high voltage capacitor, having a positive terminal and a negative terminal;

an H-bridge having an upper rail electrically connected to the positive terminal of the at least one high voltage capacitor, and a lower rail electrically connected to the negative terminal of the at least one high voltage capacitor, and at least two each legs,

each leg of the at least two legs being electrically connected to a separate one of the at least two defibrillation electrodes, and

each leg of the at least two legs further having an upper switch, electrically connected between the upper rail and the defibrillation electrode, and a lower switch, electrically connected between the defibrillation electrode and the lower rail;

a test capacitor connected in parallel with one of the upper switch or the lower switch of a leg of the H-bridge that is connected to a defibrillation electrode on the lead;

an overcurrent circuit, electrically connected in series between the lower rail of the H-bridge and the negative terminal of the at least one high voltage capacitor, the overcurrent circuit configured to detect current above a threshold;

a controller, operably connected to the at least one transformer, the upper switches and lower switches of the at least two legs of the H-bridge, and the overcurrent circuit, the controller configured to;

charge the at least one high voltage capacitor and the test capacitor,

deliver a short duration, high-voltage, biphasic test pulse between at least two of the defibrillation electrodes, and

produce a signal indicative of an anomaly in the lead when the overcurrent circuit detects a current above the threshold.

2. The implantable cardioverter defibrillator of claim 1, wherein the threshold is between 20 A and 40 A.

3. The implantable cardioverter defibrillator of claim 1, wherein the duration and voltage of the biphasic test pulse are chosen in order to minimize patient sensation.

4. The implantable cardioverter defibrillator of claim 1, wherein the defibrillation electrodes are chosen from the group consisting of:

a can electrode, a superior vena cava coil electrode, and a right ventricular coil electrode.

5. The implantable cardioverter defibrillator of claim 1, wherein the controller delivers a short duration, high-voltage, biphasic test pulse between at least two of the defibrillation electrodes by:

delivering a positive phase by closing the lower switch on a first leg and the upper on a second leg; and

delivering a negative phase by opening the lower switch on the leg and the upper switch on the second leg, and

closing the upper switch on the first leg and the lower switch on the second leg.

6. The implantable cardioverter defibrillator of claim 1, wherein the duration of the biphasic test pulse is one microsecond or less.

7. The implantable cardioverter defibrillator of claim 1, wherein the test capacitor has a capacitance between about 10 nF and 33.7 nF.

8. The implantable cardioverter defibrillator of claim 1,

wherein the controller delivers a short duration, high-voltage, biphasic test pulse between at least two of the defibrillation electrodes by:

delivering a positive phase by closing a first switch of a leg not including the test capacitor for a first duration;

waiting for a cool down interval of a second duration; and

,

delivering a negative phase by closing a second switch of the leg not including the test capacitor.

9. The implantable cardioverter defibrillator of claim 8, wherein the first and second switches of leg not including the test capacitor are silicon controlled rectifiers configured to open when current flow ceases.

10. The implantable cardioverter defibrillator of claim 8, wherein the first duration is between about 0.3 and 2 microseconds.

11. The implantable cardioverter defibrillator of claim 8, wherein the second duration is about 5 microseconds.

12. The implantable cardioverter defibrillator of claim 1, wherein each phase of the biphasic test pulse has a duration of less than about 300 nanoseconds.

13. The implantable cardioverter defibrillator of claim 1, wherein the voltage of the biphasic test pulse is between about 400V and about 700V.

14. The implantable cardioverter defibrillator of claim 1, wherein the controller is configured to deliver a plurality of test pulses at one or more increasing voltages.

15. A method for detecting an anomaly in a lead, the lead having at least one defibrillation electrode and operably coupled to an implantable cardioverter defibrillator, the implantable cardioverter defibrillator having a further defibrillation electrode, a test capacitor connected in parallel with one of an upper switch or a lower switch of a leg of an H-bridge connected to the defibrillation electrode, and an overcurrent circuit configured to detect current received through at least one of the defibrillation electrodes that is above a threshold, the method comprising:

delivering a short duration, high-voltage, biphasic test pulse between two of the defibrillation electrodes by;

delivering a positive phase test pulse of a first duration,

waiting for a cool down interval of a second duration, and

delivering a negative phase of a third duration; and

detecting an anomaly in the lead when the overcurrent circuit detects a current above the threshold.

16. The method of claim 15 wherein the first duration is about 300 ns.

17. The method of claim 16 wherein the second duration is about 5 ns.

18. The method of claim 17 wherein the third duration is about 300 ns.

19. A method for detecting an anomaly in a lead, the lead, having an right ventricular coil electrode and a superior vena cava coil electrode and operably coupled to an implantable cardioverter defibrillator, the implantable cardioverter defibrillator having a can electrode, a test capacitor connected in parallel with one of the upper switch or the lower switch of a leg of an H-bridge connected to the right ventricular coil electrode or the superior vena cava coil electrode, and an overcurrent circuit configured to detect current received through at least one of the defibrillation electrodes that is above a threshold, the right ventricular coil electrode, the superior vena cava coil electrode and the can electrode being electrically connected in parallel, the method comprising:

delivering short duration, high-voltage, positive test pulse between the right ventricular coil electrode and the can electrode and detecting a short between the can electrode and right ventricular coil electrode if the overcurrent circuit detects current above the threshold.

20. The method of claim 19, wherein the duration and voltage are chosen in order to deliver a total charge below about 4.25 μ

C.

21. The method of claim 20, wherein the duration is less than about 300 nanoseconds and the voltage is less than about 800V.

22. An implantable cardioverter defibrillator electrically connected to at least two defibrillation electrodes, at least one of the at least two defibrillation electrodes being located remotely from the defibrillator along a lead, the defibrillator comprising:

at least one high voltage transformer electrically connected between a battery and at least one high voltage capacitor, having a positive terminal and a negative terminal;

at least two circuit paths, each circuit path having a negative terminal and a positive terminal, the negative terminal of each circuit path electrically connected to the positive terminal of the at least one high voltage capacitor and the positive terminal of each circuit path electrically connected to the negative terminal of the at least one high voltage capacitor, such that each circuit path is connected in parallel to the at least one high voltage capacitor,

each circuit path further including a first switch connected in series to the negative terminal of the circuit path and to a defibrillation electrode and a second switch connected in series to the defibrillation electrode and the positive terminal of the circuit path, each defibrillation electrode isolated from the defibrillation electrodes of the one or more other circuit paths by patient tissue;

a test capacitor connected in parallel with one of the first switch or the second switch of the circuit path the is connected to a defibrillation electrode on the lead;

an overcurrent circuit, electrically connected in series between the positive terminals of each circuit path and the negative terminal of the at least one high voltage capacitor, the overcurrent circuit configured to detect current above a threshold; and

a controller, operably connected to the at least one transformer, the first and second switches of the at least two circuit paths and the overcurrent circuit, the controller configured to;

charge the at least one high voltage capacitor and the test capacitor,

deliver a short duration, high-voltage, biphasic test pulse between at least two of the defibrillation electrodes, and

produce a signal indicative of an anomaly in the lead when the overcurrent circuit detects a current above the threshold.