Subcutaneous cardiac stimulation device providing anti-tachycardia pacing therapy and method

• US 8,121,680 B2
• Filed: 05/01/2008
• Issued: 02/21/2012
• Est. Priority Date: 09/08/2004
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Falkenberg, Eric, Kroll, Mark W., Bornzin, Gene A.
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US12/113,895
• Publication Number:
  US 20080234769A1
• Time in Patent Office: 1,391 Days
• Field of Search: 607/5, 607/7, 607/9, 607/46, 607/63, 607/72, 607/4
• US Class Current: 607/4
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data

Abstract

An implantable subcutaneous cardiac device includes at least two subcutaneous electrodes adapted for placement external to a heart beneath the skin of a patient. The device further includes an arrhythmia detector that detects a sustained tachyarrhythmia of the heart and a pulse generator that delivers anti-tachycardia pacing pulses to the subcutaneous electrodes in response to detection of a sustained tachyarrhythmia. The pacing pulses preferably have waveforms devoid of any exponential voltage decay and include rounded or substantially constant portions to minimize pain.

Claims

1. An implantable subcutaneous cardiac device comprising:

at least two subcutaneous electrodes adapted for placement near a heart but neither in nor on a heart and not in a vein associated with the heart; and

a pulse generator that delivers a pacing pulse to the subcutaneous electrodes, the pacing pulse having a waveform consisting of a positive phase devoid of any exponential voltage decay and a negative phase devoid of any exponential voltage decay, wherein the positive phase initiates at a baseline voltage and includes a first portion curving away from the baseline voltage toward a peak voltage and a second portion curving along its entire length away from the peak voltage back to the baseline voltage, wherein the baseline voltage is the voltage level at which the positive phase transitions to the negative phase;

wherein the positive phase and the negative phase are each defined by a rounded waveform having a width and a peak voltage, the peak voltage of the rounded waveform defining the positive phase is greater than the peak voltage of the rounded waveform defining the negative phase, and the width of the rounded waveform defining the positive phase is less than the width of the rounded waveform defining the negative phase.

2. The device of claim 1 wherein the pulse generator provides anti-tachycardia pacing pulses.

3. The device of claim 2 wherein the pulse generator provides electrical nerve stimulation pulses prior to providing the pacing pulses.

4. The device of claim 3 wherein the pulse generator provides the nerve stimulation pulses to the at least two subcutaneous electrodes.

5. The device of claim 2 further comprising an arrhythmia detector that detects a tachyarrhythmia of the heart and wherein the pulse generator delivers anti-tachycardia pacing pulses to the subcutaneous electrodes in response to detection of a tachyarrhythmia.

6. The device of claim 5 wherein the device causes a cardioversion shock to be delivered to the heart when the arrhythmia detector detects a tachyarrhythmia after delivery of the anti-tachycardia pacing pulses.

7. The device of claim 6 further comprising a telemetry circuit that enables a fully implanted stimulation device to provide the cardioversion shock.

8. The device of claim 6 further comprising a shocking circuit that provides the cardioversion shock.

9. The device of claim 2 further comprising a telemetry circuit that enables a fully implanted stimulation device to provide anti-tachycardia pacing pulses to the heart before the pulse generator delivers anti-tachycardia pacing pulses.

10. The device of claim 1 further comprising an evoked response detector that detects for evoked responses from the pacing pulses and wherein the pulse generator provides an increased pacing output responsive to a failure to detect the evoked responses.

11. The device of claim 1 wherein the peak voltage of the positive phase is about twice the peak voltage of the negative phase.

12. The device of claim 1 wherein the width of the positive phase is about half the width of the negative phase.

13. The device of claim 1 wherein the negative phase includes a first portion curving away from the baseline voltage toward a peak negative voltage and a second portion curving along its entire length away from the peak negative voltage to the baseline voltage.

14. A method comprising:

detecting a tachyarrhythmia of a heart with at least two subcutaneous electrodes near a heart but neither in nor on a heart and not in a vein associated with the heart; and

delivering anti-tachycardia pacing pulses to the subcutaneous electrodes, the pacing pulses having waveforms consisting of a positive phase devoid of any exponential voltage decay and a negative phase devoid of any exponential voltage decay, wherein the positive phase initiates at a baseline voltage and includes a first portion curving away from the baseline voltage toward a peak voltage and a second portion curving along its entire length away from the peak voltage back to the baseline voltage, wherein the baseline voltage is the voltage level at which the positive phase transitions to the negative phase, wherein the positive phase and the negative phase are each defined by a rounded waveform having a width and a peak voltage, the peak voltage of the rounded waveform defining the positive phase is greater than the peak voltage of the rounded waveform defining the negative phase, and the width of the rounded waveform defining the positive phase is less than the width of the rounded waveform defining the negative phase.

15. The method of claim 14 further comprising applying nerve stimulation pulses to the at least two subcutaneous electrodes prior to delivering the anti-tachycardia pacing pulses.

16. The method of claim 14 further comprising redetecting for a tachyarrhythmia following delivery of the anti-tachycardia pacing pulses and applying a cardioversion shock to the heart responsive to redetecting a tachyarrhythmia.

17. The method of claim 16 wherein applying comprises commanding a fully implanted cardiac stimulation device to apply the cardioversion shock.

18. The method of claim 14 further comprising detecting for evoked responses to the anti-tachycardia pacing pulses and increasing stimulation energy of the pacing pulses responsive to failing to detect evoked responses.

19. The method of claim 14 further comprising applying anti-tachycardia pacing pulses to the heart with intracardiac electrodes before delivering the anti-tachycardia pacing pulses to the subcutaneous electrodes.

20. The method of claim 14 wherein the negative phase includes a first portion curving away from the baseline voltage toward a peak negative voltage and a second portion curving along its entire length away from the peak negative voltage to the baseline voltage.

21. An implantable cardiac device comprising:

at least two electrodes adapted for placement in, on or near a heart; and

a pulse generator that delivers a pacing pulse to the electrodes, the pacing pulse having a waveform consisting of a positive phase devoid of any exponential voltage decay and any truncation, and a negative phase devoid of any exponential voltage decay and any truncation, the positive phase including a first portion curving away from a baseline voltage toward a peak voltage and a second portion curving along its entire length away from the peak voltage back to the baseline voltage;

wherein the positive phase and the negative phase are each defined by a rounded waveform having a width and a peak voltage, the peak voltage of the rounded waveform defining the positive phase is greater than the peak voltage of the rounded waveform defining the negative phase, and the width of the rounded waveform defining the positive phase is less than the width of the rounded waveform defining the negative phase.