Medium voltage therapy applications in treating cardiac arrest

• US 8,401,637 B2
• Filed: 11/22/2005
• Issued: 03/19/2013
• Est. Priority Date: 11/24/2004
• Status: Active Grant

• Current Assignee: Galvani, Ltd.
• Original Assignee: Galvani, Ltd.
• Inventors: Kroll, Kai, Kroll, Mark, Bugliosi, Tom
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): EL-KAISSI, HIBA CARINE
• Application Number:
  US11/285,756
• Publication Number:
  US 20060142809A1
• Time in Patent Office: 2,674 Days
• Field of Search: 607/8, 607/28
• US Class Current: 607/5
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/39044 in combination with cardiopulmonary resuscitation [CPR] therapy
• CPC Class Codes: A61N 1/39046 User protection from shock
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3993 User interfaces for automatic external defibrillators

Abstract

A method and system for treating an individual experiencing cardiac arrest using an automatic external defibrillator (AED) includes placing a first and a second electrode of the AED in electrical communication with an exterior surface of the individual. A need to apply a high voltage defibrillation signal to the individual is automatically determined. The method also includes automatically causing the AED to apply a medium voltage therapy (MVT) signal through the first and the second electrodes to the individual. The MVT signal is applied to induce a hemodynamic effect in the individual. Alternatively, or additionally, the MVT signal is applied to induce a respiratory effect in the individual. Optionally, the MVT signal is applied before determining the need to apply the defibrillation signal.

Claims

1. An improved automated external defibrillator (AED), the AED including a set of electrodes that are adapted to interface with an exterior surface of a patient, defibrillation circuitry that is adapted to generate and deliver a defibrillation shock to the patient via the set of electrodes, patient monitoring circuitry that is adapted to sense a patient condition based on cardiac activity of the patient, and at least one controller interfaced with the patient monitoring circuitry and the defibrillation circuitry, the at least one controller including logic configured to determine if the patient condition is treatable by administration of the defibrillation shock and, if so, to control generation and delivery of the defibrillation shock, the improvement comprising:

additional logic in the at least one controller configured to recognize whether the patient condition is treatable by cardio-pulmonary resuscitation (CPR); and

electrical CPR circuitry interfaced with the at least one controller, and adapted to generate and deliver medium voltage therapy (MVT) via the set of electrodes in response to a recognition, by the at least one controller, that the patient condition t-hat-is treatable by CPR, the MVT being continuous for a duration on the order of minutes, and having amplitude and waveform characteristics to (a) electrically force mechanical pumping action of the patient'"'"'s heart via electrical stimulation of cardiac muscle cells, and (b) mechanically force pumping action of the patient'"'"'s heart via electrical stimulation of non-cardiac muscle cells resulting in compression of the heart, during that duration;

wherein the electrical CPR circuitry is adapted to produce the MVT having amplitude and waveform characteristics such that, in the electrically forced mechanical pumping action in (a), diastolic cardiac muscle cells are forced to contract during each of a plurality of intervals and systolic cardiac muscle cells are prevented from relaxing during those intervals, and between successive ones of the plurality of intervals the cardiac muscle cells are not forced.

2. The improved AED of claim 1, wherein the electrical CPR circuitry generates MVT having a waveform for electrically forcing mechanical pumping action in (a) that includes a plurality of packets of pulses, wherein each packet causes the diastolic cardiac muscle cells to contract and causes the systolic cardiac muscle cells to remain contracted for a duration longer than they would otherwise remain contracted in an absence of the MVT.

3. The improved AED of claim 1, wherein the MVT includes a waveform that is adapted to cause sympathetic nerve stimulation facilitating cardiac myocyte contractility and excitability in the patient.

4. The improved AED of claim 1, wherein the additional logic in the at least one controller is configured to selectively adjust at least one MVT control parameter controlling the generating and delivery of the MVT that affects at least one characteristic of the MVT selected from the group consisting of:

a time duration between successive pulses, a pulse duration, a time duration between the first packet and the second packet, or any combination thereof.

5. The improved AED of claim 1, wherein the MVT includes at least one pulse having a time constant that is short enough to stimulate skeletal muscle tissue in the patient.

6. The improved AED of claim 1, wherein the improvement further comprises:

monitoring equipment operably interfaced with the at least one controller to automatically monitor an additional physiologic condition of the patient.

7. The improved AED of claim 6, wherein the monitoring equipment is configured to facilitate at least one type of automatic monitoring selected from the group consisting of:

monitoring of a patient'"'"'s fingertip pulse oximetry, monitoring of a patient'"'"'s respiration, and monitoring of an arterial pulse of the patient.

8. The improved AED of claim 1, wherein the electrical CPR circuitry is adapted to produce the MVT having amplitude and waveform characteristics such that, in the mechanically forced pumping action in (b), a combination of physiologic effects is produced in the patient by the MVT to cause the mechanically forced pumping action of the patient'"'"'s heart, the combination including a plurality of muscular contraction events in the patient'"'"'s chest region, a plurality of muscular contraction events in the patient'"'"'s abdominal region, and stimulation of the patient'"'"'s phrenic nerve.

9. The improved AED of claim 1, wherein the AED further includes an operator interface that includes a graphical display interfaced with the at least one controller and wherein the improvement further comprises:

a display on the graphical display that includes a plot of an electrocardiogram (ECG) curve obtained from the patient, and an MVT application indicator plotted together with the ECG curve, the MVT indicator indicating at least one instance of MVT application relative in time to events represented by the ECG curve.

10. The improved AED of claim 1, wherein the same electrodes of the set of electrodes through which the defibrillation shock is delivered are used to deliver the MVT.

11. The improved AED of claim 1, wherein the at least one controller is configured to deliver the MVT while the defibrillation circuitry is charging up to deliver the defibrillation shock.

12. The improved AED of claim 1, wherein the MVT includes at least one waveform portion that has an amplitude of greater than 100 volts.

13. The improved AED of claim 1, wherein the MVT has amplitude and waveform characteristics to electrically force ventilation in the patient via the electrical stimulation of the non-cardiac muscle cells.

14. The improved AED of claim 1, wherein the duration during which the electrical CPR circuitry is configured to produce the MVT is at least two seconds.

15. The improved AED of claim 2, wherein within each packet of pulses, the intra-packet pulse duration is at most 10 milliseconds.

16. A hand-portable automated external defibrillator (AED) system comprising:

a set of electrodes that are adapted to interface with an exterior surface of a patient;

a patient monitoring sub-system that is operatively coupled to the set of electrodes and adapted to sense a patient condition based at least partly on cardiac activity of the patient;

defibrillation circuitry that is operatively coupled to the set of electrodes and adapted to generate and deliver a defibrillation shock to the patient via the set of electrodes in response to the patient condition sensed by the patient monitoring sub-system that is determined to be treatable by defibrillation;

electrical CPR circuitry that is operatively coupled to the set of electrodes and adapted to generate and deliver medium voltage therapy (MVT), via the same set of electrodes as those used for delivery of the defibrillation shock, in response to a patient condition sensed by the patient monitoring sub-system that is determined to be treatable by CPR;

at least one controller interfaced with the patient monitoring sub-system, the defibrillation circuitry and the electrical CPR circuitry, the at least one controller being configured to;

determine whether the patient condition sensed by the patient monitoring sub-system is treatable by either or both of the defibrillation or the CPR;

control generation and delivery of the defibrillation shock in response to a determination of the patient condition being treatable by defibrillation, and control generation and delivery of the MVT in response to a determination of the patient condition being treatable by CPR;

wherein the electrical CPR circuitry is configured to produce the MVT that is continuous for a duration on the order of minutes, and sufficient to cause both a hemodynamic effect and a respiratory effect in the patient during that duration, wherein the hemodynamic effect is achieved via;

targeted stimulation of cardiac muscle cells to electrically stimulate relaxed cells to contract and to electrically stimulate contracted cells to extend their contraction duration, and

targeted stimulation of non-cardiac chest muscle cells to electrically force chest compressions causing a mechanical pumping effect of the heart; and

wherein the respiratory effect is achieved via the targeted stimulation of the non-cardiac muscle cells to force some amount of ventilation;

wherein the electrical CPR circuitry is adapted to produce an MVT waveform targeting stimulation of the cardiac muscle cells having a pulsed packet output with intra-packet pulse widths of between 2 ms and 10 ms; and

wherein the electrical CPR circuitry is adapted to produce an MVT waveform targeting stimulation of the non-cardiac muscle cells having a pulsed packet output with intra-packet pulse widths of between 0.05 ms and 0.2 ms; and

wherein the electrical CPR circuitry is adapted to deliver the MVT having a pulsed output voltage of 75-1000 V, a pulsed output current of between 0.05-10.00 A, a pulsed packet rate of between 20-180 packets/minute, a pulsed packet duration of between 10-3000 ms, and an intra-packet pulse rate of between 20-500 Hz.

17. The AED system of claim 16 wherein the MVT waveform is targeted for generating a coronary perfused pulse and has a pulsed output with a voltage of between 75-300 V, a pulsed output current of between 0.5-6.0 A, a pulsed packet rate of between 70-100 packets/minute, a pulsed packet duration of between 80-120 ms, an intra-packet pulse duration of between 2.0-6.0 ms, and an intra-packet pulse rate of between 30-75 Hz.

18. The AED system of claim 16 wherein the pulsed output of the MVT is delivered multiple times by the at least one controller with varied parameter values and an initial parameter value of the pulsed output has a pulsed output voltage of about 250 V, a pulsed output current of between 1.0-5.0 A, a pulsed packet rate of about 90 packets/minute, a pulsed packet duration of about 100 ms, an intra-packet pulse duration of about 4.0 ms, and an intra-packet pulse rate of about 100 Hz.

19. The AED system of claim 16 wherein the MVT waveform that is targeted for generating a respiration effect and has a pulsed output voltage of between 75-300 V, a pulsed output current of between 50-500 mA, a pulsed packet rate of between 20-30 packets/minute, a pulsed packet duration of between 0.5-3.0 second, an intra-packet pulse duration of between 0.05 and 0.2 ms, and an intra-packet pulse rate of between 25-150 Hz.

20. The AED system of claim 16 wherein the patient monitoring sub-system further includes at least one component to monitor a measured effectiveness of the MVT and wherein the controller selectively adjusts at least one variable parameter of the pulsed output in response to the measured effectiveness.

21. The AED system of claim 20, wherein the at least one variable parameter of the pulsed output is selected from the group consisting of:

the pulsed output voltage, the pulsed packet rate, the pulsed packet duration, the intra-packet pulse duration, and the intra-packet pulse rate.

22. The improved AED of claim 16, wherein the duration during which the electrical CPR circuitry is configured to produce the MVT is at least two seconds.

23. The AED system of claim 16 wherein the electrical CPR circuitry is configured to produce an MVT that is sufficient to stimulate the patient'"'"'s phrenic nerve to cause a contraction in the diaphragm of the patient and thereby expand the chest, wherein the stimulation to contract the diaphragm is timed to alternate with MVT that stimulates the cardiac and non-cardiac muscles to thereby alternately draw blood into the heart while the heart is un-compressed, and pump blood out of the heart while the diaphragm is un-contracted.