Method and apparatus for generating adaptive n-phasic defibrillation waveforms

• US 5,372,606 A
• Filed: 10/07/1993
• Issued: 12/13/1994
• Est. Priority Date: 10/07/1993
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Lang, Douglas J., Swanson, David K.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US08/132,947
• Time in Patent Office: 432 Days
• Field of Search: 607/5, 607/6, 607/7, 607/8
• US Class Current: 607/6
• CPC Class Codes: A61N 1/3937 Monitoring output parameters

Abstract

A method and apparatus for delivering an adaptive n-phasic waveform to the heart in either a fixed-tilt delivery mode or a fixed-duration delivery mode. A first phase of a first polarity is delivered to the heart. The first phase is set to terminate upon decaying to a preset level. If the first phase does not decay to the preset level within a predetermined maximum period of time, the first phase is terminated and the subsequent phases are delivered in a fixed-duration delivery mode. Because the first phase did not decay fast enough, it is determined that the patient has a relatively high system impedance. Therefore, subsequent phases will be delivered to the patient in a fixed-duration mode to insure the defibrillation is reversed. Otherwise, if the first phase decays to the preset level in less than the maximum predetermined period of time, it is determined that the patient has a relatively low system impedance and subsequent phases should be delivered in a fixed-tilt mode.

Claims

1. A method for delivering an adaptive n-phasic defibrillation waveform to the heart comprising the steps of:

monitoring the electrical activity of the heart;

setting a predetermined maximum amount of time for which a first phase of said n-phasic defibrillation waveform may last;

delivering said first phase of said n-phasic defibrillation waveform to the heart upon detecting an arrhythmia of the heart in a fixed-tilt delivery mode so that said first phase terminates upon the level of said first phase decreasing to a preset level;

monitoring the time duration of said first phase;

terminating said first phase and switching to a fixed-duration delivery mode if the time duration of said first phase is greater than or equal to said predetermined maximum amount of time;

delivering phases of said n-phasic defibrillation waveform, subsequent said first phase, in alternating polarities to the heart in a fixed-duration delivery mode if the time duration of said first phase is greater than or equal to said predetermined maximum amount of time whereby each of said subsequent phases terminates upon the duration of the phase meeting a preset value; and

delivering phases of said n-phasic defibrillation waveform, subsequent said first phase, and in alternating polarities to the heart in a fixed-tilt mode if the time duration of said first phase is not greater than or equal to said predetermined maximum amount of time whereby each of said subsequent phases terminates upon the level of the phase decreasing to a preset value.

2. The method of claim 1, and further comprising the steps of:

presetting the total duration of said n-phasic defibrillation waveform; and

presetting the waveshape of each of said phases of said n-phasic defibrillation waveform by setting the duration of each of said phases as a percentage of the total duration of said n-phasic defibrillation waveform.

3. The method of claim 1, further comprising the step of:

presetting the waveshape of each phase subsequent said first phase by setting the duration of said each phase as a percentage of the duration of the first phase.

4. The method of claim 3, wherein said percentage is determined by the preset value for said each phase divided by the predetermined maximum amount of time of the first phase.

5. The method of claim 1, and further comprising the steps of:

providing a defibrillation capacitor;

presetting the initial voltage level of said defibrillation capacitor, said initial voltage level being an initial voltage level of said first phase of said n-phasic defibrillation waveform; and

presetting the waveshape of each of said phases of said n-phasic defibrillation waveform by setting the voltage tilt of each of said phases as a percentage of the initial voltage level of said defibrillation capacitor.

6. An apparatus for delivering an adaptive n-phasic defibrillation waveform to the heart comprising:

monitoring means for monitoring the electrical activity of the heart;

defibrillation electrode means adapted to be mounted on or about the heart;

defibrillation capacitor means connected to said defibrillation electrode means;

charging means connected to said defibrillation capacitor means for charging said defibrillation capacitor means to an initial voltage level;

n-phasic output means connected to said defibrillation capacitor means for delivering the voltage charged on said defibrillation capacitor means to said defibrillation electrode means in a sequence of consecutive phases of controlled durations and amplitudes to form an n-phasic defibrillation waveform;

control means connected to said n-phasic output means, said monitoring means, and said charging means, said control means being operable for monitoring and controlling the duration and polarity of each of said phases of said n-phasic defibrillation waveform and triggering said charging means to charge said defibrillation capacitor means upon said monitoring means detecting an arrhythmia of the heart, said control means further controlling said n-phasic output means to deliver said n-phasic defibrillation waveform in either a fixed-tilt mode or a fixed-duration mode;

programming means for setting a predetermined maximum amount of time for which a first phase of said n-phasic defibrillation waveform may last;

said control means being further operable for controlling said n-phasic output means to deliver said first phase of said n-phasic defibrillation waveform in a fixed-tilt delivery mode to the heart upon said monitoring means detecting an arrhythmia of the heart so that said first phase terminates upon the amplitude of said first phase decreasing to a preset level, triggering said n-phasic output means to terminate said first phase and switching to a fixed-duration delivery mode if the time duration of said first phase meets or exceeds said predetermined maximum amount of time, controlling said n-phasic output means to deliver phases of said n-phasic defibrillation waveform, subsequent said first phase, to the heart and in alternating polarities in a fixed-duration delivery mode if the time duration of said first phase is at least equal to said predetermined maximum amount of time whereby each of said subsequent phases terminates upon the duration of the phase meeting a preset value, and triggering said n-phasic output means to deliver phases of said n-phasic defibrillation waveform, subsequent said first phase, to the heart and in alternating polarities in a fixed-tilt mode if the time duration of said first phase is at least equal to said predetermined maximum amount of time whereby each of said subsequent phases terminates upon the level of the phase decreasing to a preset value.

7. The apparatus of claim 6, wherein said programming means is operable for presetting the total duration of said n-phasic defibrillation waveform, and presetting the waveshape of each of said phases of said n-phasic defibrillation waveform by setting the duration of each of said phases as a percentage of the total duration of said n-phasic defibrillation waveform.

8. The apparatus of claim 6, wherein said programming means is operable for presetting the waveshape of each phase subsequent said first phase by setting the duration of said each phase as a percentage of the duration of the first phase.

9. The apparatus of claim 8, wherein said programming means is operable for presetting the waveshape of each phase subsequent said first phase by determining said percentage by dividing the preset value for said each phase by the predetermined maximum amount of time of the first phase.

10. The apparatus of claim 6, wherein said programming means is operable for presetting the initial voltage level of said defibrillation capacitor means, said initial voltage level being an initial voltage level of said first phase of said n-phasic defibrillation waveform, and for presetting the waveshape of each of said phases of said n-phasic defibrillation waveform by setting a maximum voltage of each of said phases as a percentage of the initial voltage level of said defibrillation capacitor.

11. A method for delivering an adaptive n-phasic defibrillation waveform to the heart in either a fixed-tilt mode or a fixed-duration mode, the method comprising the steps of:

monitoring the electrical activity of the heart;

setting a predetermined maximum amount of time for which a first phase of said n-phasic defibrillation waveform may last;

charging a defibrillation capacitor to an initial voltage level upon detecting an arrhythmia of the heart;

discharging said defibrillation capacitor for delivering said first phase of said n-phasic defibrillation waveform to the heart upon detecting an arrhythmia of the heart in a fixed-tilt delivery mode so that said first phase terminates upon the voltage level of said first phase decreasing to a preset level;

monitoring the time duration and voltage level of said first phase;

terminating said first phase and switching to a fixed-duration delivery mode if the time duration of said first phase is greater than or equal to said predetermined maximum amount of time before said voltage level of said first phase decreases to said preset level;

delivering phases of said n-phasic defibrillation waveform, subsequent said first phase, to the heart in a fixed-duration delivery mode if the time duration of said first phase is greater than or equal to said predetermined maximum amount of time; and

delivering phases of said n-phasic defibrillation waveform, subsequent said first phase, to the heart in a fixed-tilt mode if the time duration of said first phase does not meet or exceed said predetermined maximum amount of time before the voltage level of said first phase decreases to said preset level.

12. The method of claim 11, and further comprising the step of alternating the polarity of the voltage of consecutive phases of said n-phasic defibrillation waveform.

13. A method for delivering an adaptive n-phasic defibrillation waveform to the heart comprising the steps of:

monitoring the electrical activity of the heart;

setting a predetermined maximum amount of time for which a first phase of said n-phasic defibrillation waveform may last;

charging a defibrillation capacitor to an initial voltage level upon detecting an arrhythmia of the heart;

discharging said defibrillation capacitor for delivering said first phase in a first polarity to the heart in a fixed-tilt delivery mode upon detecting an arrhythmia of the heart so that said first phase terminates upon the voltage level of said first phase decreasing to a preset level;

monitoring the time duration and voltage level of said first phase;

terminating said first phase and switching to a fixed-duration delivery mode if the time duration of said first phase is greater than or equal to said predetermined maximum amount of time before said voltage level of said first phase decreases to said preset level;

delivering a second phase in a second polarity opposite to said first polarity if the time duration of said first phase is greater than or equal to said predetermined maximum amount of time before said voltage level of said first phase decreases to said preset level;

delivering phases of said n-phasic defibrillation waveform, subsequent said first phase, to the heart and in alternating polarities in a fixed-duration delivery mode if the time duration of said first phase is greater than or equal to said predetermined maximum amount of time; and

delivering phases of said n-phasic defibrillation waveform, subsequent said first phase, to the heart and in alternating polarities in a fixed-tilt mode if the time duration of said first phase does not meet or exceed said predetermined maximum amount of time before the voltage level of said first phase decreases to said preset level.

14. The method of claim 13, and further comprising the steps of:

presetting the number of phases of said n-phasic defibrillation waveform;

counting the number of phases before they are delivered to the heart; and

terminating shock delivery if said counted number of phases exceeds said preset number of phases.

15. A method for delivering an adaptive n-phasic defibrillation waveform to the heart comprising the steps of:

delivering a first phase to the heart in a first polarity;

monitoring the level and duration of said first phase;

declaring that the patient has a relatively low system impedance or capacitance if said first phase decays to a preset value within a maximum period of time and delivering phases subsequent to said first phase in alternating polarities and in a fixed-tilt delivery mode whereby each of said subsequent phases terminates upon the level of the phase decaying to a preset value; and

declaring that the patient has a relatively high system impedance or capacitance if said first phase does not decay to said preset value within said maximum period of time and delivering phases subsequent to said first phase in alternating polarities in a fixed-duration delivery mode whereby each of said subsequent phases terminates upon the duration of the phase meeting a preset value.