Adaptive medium voltage therapy for cardiac arrhythmias

• US 8,483,822 B1
• Filed: 07/02/2010
• Issued: 07/09/2013
• Est. Priority Date: 07/02/2009
• Status: Active Grant

• Current Assignee: Galvani, Ltd.
• Original Assignee: Galvani, Ltd.
• Inventors: Kroll, Mark W., Gilman, Byron L., Brewer, James E.
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US12/830,251
• Time in Patent Office: 1,103 Days
• Field of Search: 607/2, 607/5, 607/18, 607/119
• US Class Current: 607/5
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/3904 External heart defibrillators [EHD]
• CPC Class Codes: A61N 1/39044 in combination with cardiopulmonary resuscitation [CPR] therapy
• 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 1/3968 Constructional arrangements, e.g. casings A61N1/375 takes precedence
• CPC Class Codes: A61N 1/3993 User interfaces for automatic external defibrillators

Abstract

Aspects of the invention are directed to advanced monitoring and control of medium voltage therapy (MVT) in implantable and external devices. Apparatus and methods are disclosed that facilitate dynamic adjustment of MVT parameter values in response to new and changing circumstances such as the patient'"'"'s condition before, during, and after administration of MVT. Administration of MVT is automatically and dynamically adjusted to achieve specific treatment or life-support objectives, such as prolongation of the body'"'"'s ability to endure and respond to MVT, specifically addressing the type of arrhythmia or other pathologic state of the patient with targeted treatment, a tiered-intensity MVT treatment strategy, and supporting patients in non life-critical conditions where the heart may nevertheless benefit from a certain level of assistance.

Claims

1. An electrotherapy device for treating arrhythmia in a patient, the device comprising:

a patient interface including;

a plurality of electrodes adapted to be placed in electrical contact with the patient; and

at least one hemodynamic sensor;

electrotherapy circuitry operatively coupled to the patient interface and including a medium voltage therapy (MVT) pulse generator adapted to supply the MVT via the patient interface as a configurable waveform having a set of adjustable waveform parameters, wherein the waveform is defined by series of pulse trains having an adjustable train repetition rate, the pulse trains being composed of pulses having an adjustable pulse width, an adjustable pulse period, and an adjustable pulse amplitude, the MVT being of an energy level insufficient to shock the heart into a reset state;

patient monitoring circuitry including;

arrhythmia monitoring circuitry operatively coupled to at least a pair of the plurality of electrodes; and

cardiac output monitoring circuitry operatively coupled to the at least one hemodynamic sensor;

a controller operatively coupled to the patient monitoring circuitry and the electrotherapy circuitry, and configured to;

based on an output of the arrhythmia monitoring circuitry and on the cardiac output monitoring circuitry, ascertain a patient condition that is treatable by the MVT;

based on a treatment or life-support objective corresponding to the patient condition treatable by the MVT, cause the electrotherapy circuitry to initiate application of the MVT to the musculature of the patient via the plurality of electrodes to target a selected muscle group, wherein the selected muscle group is repeatedly (a) forced into a contracted state, (b) maintained in the contracted state for a time sufficient to achieve myocardial perfusion, and (c) thereafter allowed to relax, thereby achieving a forced hemodynamic effect sufficient to reduce a rate of degradation of the condition of the patient;

based on continued monitoring by the cardiac output monitoring circuitry during application of the MVT, adjust the waveform parameters in furtherance of the treatment or life-support objective such that;

in response to a measured level of cardiac output during application of the MVT targeting a selected first muscle group exceeding a minimal level adequate for the treatment or life-support objective, reduce an intensity of MVT stimulation targeting the first muscle group;

in response to a measured reduction of level of cardiac output during application of the MVT targeting a selected first muscle group, cause the electrotherapy circuitry to target a selected second muscle group distinct from the first muscle group with the MVT.

2. The electrotherapy device of claim 1, wherein the controller is configured such that the reduction in MVT intensity and targeting of the second muscle group are performed to reduce muscle fatigue in the first muscle group caused by the MVT.

3. The electrotherapy device of claim 1, wherein the first muscle group consists of primarily myocardial musculature and the second muscle group consists of primarily skeletal musculature.

4. The electrotherapy device of claim 1, wherein the first muscle group consists of primarily myocardial musculature and the second muscle group consists of primarily musculature of the diaphragm.

5. The electrotherapy device of claim 1, wherein the controller is configured to cause the electrotherapy circuitry to target the second muscle group by applying the MVT with a set of adjusted waveform parameters adapted to more efficiently stimulate to the second muscle group.

6. The electrotherapy device of claim 1, wherein the plurality of electrodes includes electrodes positioned at various regions of the torso of the patient, and wherein the electrotherapy circuitry is adapted to selectively apply the MVT to specific one or more regions via selected groupings of the plurality of electrodes such that various different muscle groups of skeletal musculature are selectively targeted, and wherein the first muscle group and the second muscle group respectively correspond to different regions of the torso of the patient.

7. The electrotherapy device of claim 6, wherein the controller maintains at least one more data structure that relates each of the different muscle groups to amplitude and waveform parameter information corresponding to that muscle group, wherein different muscle groups correspond to different waveform and amplitude characteristics.

8. The electrotherapy device of claim 6, wherein one of the muscle groups consists of skeletal muscles on the left side of the patient, and another one of the muscle groups consists of skeletal muscles on the right side of the patient.

9. The electrotherapy device of claim 6, wherein one of the muscle groups consists of abdominal muscles, and another one of the muscle groups consists of intercostals muscles.

10. The electrotherapy device of claim 1, wherein the electrotherapy circuitry further comprises:

a high voltage therapy (HVT) pulse generator operatively coupled to the patient interface and adapted to supply the HVT via the patient interface, wherein the HVT is of an energy level sufficient to shock the heart into a reset state; and

wherein the controller is further configured to;

based on a treatment or life-support objective corresponding to the patient condition treatable by the HVT, cause the electrotherapy circuitry to apply the MVT targeting primarily myocardial musculature at a progressively reducing intensity as a time at which the HVT is to be applied approaches;

cause the electrotherapy circuitry to target skeletal musculature at high intensity as the time at which the HVT is to be applied approaches; and

thereafter, cause electrotherapy circuitry to apply the HVT to the patient via the patient interface.

11. The electrotherapy device of claim 1, wherein the hemodynamic sensor is configured to measure at least one hemodynamic condition selected from the group consisting of:

blood flow, blood pressure, blood oxygenation, or any combination thereof.

12. The electrotherapy device of claim 1, wherein the hemodynamic sensor includes at least one sensor selected from the group consisting of:

a pulse oximeter, a sonic arterial pulse sensor, a gas sensor, a blood pressure sensor, a impedance measuring arrangement, or any combination thereof.

13. The electrotherapy device of claim 1, wherein cardiac output monitoring circuitry is configured to distinguish between hemodynamic conditions of forced pulse output and return, and wherein the controller is configured to adjust the MVT parameters in response to detected differences in the hemodynamic conditions of forced pulse output and return.

14. The electrotherapy device of claim 13, wherein the controller is configured to such that:

in response to an indication of weak return but adequately high pulse pressure to meet the treatment or life-support objective, the MVT is adjusted to enhance and prolong the targeting of muscles that tend to expand the chest cavity, thereby lowering pressure around the heart to help draw in more blood; and

in response to a strong return but weak pulse the MVT is adjusted to extend the pulse train duration to force the heart to stay contracted for a longer period of time.

15. The electrotherapy device of claim 1, wherein the device is configured to modulate the pulse period of the MVT.

16. The electrotherapy device of claim 1, wherein the patient monitoring circuitry is configured to detect pulseless electrical activity (PEA) in the patient, and wherein the controller is configured to respond to detection of PEA by causing the electrotherapy circuit to apply MVT synchronized with a measured electrocardiogram (ECG) signal.

17. The electrotherapy device of claim 1, wherein the MVT pulse generator is constructed such that the train repetition rate is adjustable within the range of 30 and 120 per minute, the pulse width is adjustable within the range of 0.15 and 10 milliseconds and an the pulse period is adjustable within the range of 5 and 70 milliseconds.

18. The electrotherapy device of claim 1, wherein the MVT pulse generator is constructed such that a pulse current of the MVT delivered to the patient falls within the range of 0.25 and 5 amperes.

19. The electrotherapy device of claim 1, wherein the controller is configured to cause the electrotherapy circuitry to apply a first MVT waveform targeting the first muscle group and, immediately thereafter, apply a second MVT waveform targeting the second muscle group such that the musculature of the first muscle group and the second muscle group continuously maintain compression of the heart.