Medium voltage therapy applied as a test of a physiologic state

• US 9,144,684 B2
• Filed: 07/22/2014
• Issued: 09/29/2015
• Est. Priority Date: 07/02/2009
• Status: Active Grant

• Current Assignee: Galvani, Ltd.
• Original Assignee: Galvani, Ltd.
• Inventors: Gilman, Byron L., Kroll, Mark W., Brewer, James E.
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US14/337,700
• Publication Number:
  US 20140336718A1
• Time in Patent Office: 434 Days
• Field of Search: 607/2, 607/5, 607/18
• US Class Current: 1/1
• 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;

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, and (c) thereafter allowed to relax, thereby achieving a forced hemodynamic output in the patient;

based on an output of the patient monitoring circuitry, and in response to application of the MVT, ascertain an initial hemodynamic state of the patient;

adjust the waveform parameters to establish a test hemodynamic condition in the patient as a response to the applied MVT, the test hemodynamic condition being associated with an expected hemodynamic state; and

ascertain a difference between the expected hemodynamic state and an actual physiologic state in the patient responsive to the hemodynamic condition, the difference being indicative of an ascertained patient condition.

2. The electrotherapy device of claim 1, wherein the controller is further configured to adjust the waveform parameters to achieve a treatment objective for treating the ascertained patient condition.

3. The electrotherapy device of claim 1, wherein the waveform parameters adjusted to establish the test hemodynamic condition include waveform parameters to apply a relatively higher-intensity MVT to a first muscle group, and a relatively lower-intensity MVT to a second muscle group, wherein the ascertained patient condition represents an endurance of the patient to MVT.

4. The electrotherapy device of claim 3, wherein the first muscle group and the second muscle group are on opposite sides of the patient.

5. The electrotherapy device of claim 1, wherein the patient monitoring circuitry includes blood oxygenation monitoring circuitry, wherein the test hemodynamic condition includes forced perfusion and forced ventilation, and wherein the ascertained patient condition includes a measure of respiration performance of the patient.

6. The electrotherapy device of claim 5, wherein the controller is further configured to adjust the waveform parameters to achieve an increase in forced ventilation in response to application of the MVT.

7. The electrotherapy device of claim 1, wherein the ascertained patient condition includes an indication of a relatively strong pulse and a relatively weak return.

8. The electrotherapy device of claim 7, wherein the controller is further configured to adjust the waveform parameters to prolong expansion of the chest cavity of the patient in response to the ascertained patient condition.

9. The electrotherapy device of claim 1, wherein the ascertained patient condition includes an indication of a relatively weak pulse and a relatively strong return.

10. The electrotherapy device of claim 9, wherein the controller is further configured to adjust the waveform parameters to prolong contraction of the heart of the patient in response to the ascertained patient condition.

11. The electrotherapy device of claim 10, wherein in response to the ascertained patient condition, the MVT is adjusted to deliver a first MVT waveform targeting a first muscle group immediately followed by a second MVT waveform targeting a second muscle group such that the musculature of the first muscle group and the second muscle group continuously maintain compression of the heart.

12. 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.

13. 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.

14. A method for treating arrhythmia in a patient using an electrotherapy device, the method comprising:

providing a patient interface, including a plurality of electrodes and at least one hemodynamic sensor, placed in electrical contact with the patient;

generating medium voltage therapy (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;

monitoring the patient via the patient interface for an occurrence of an arrhythmia;

in response to a detected occurrence of an arrhythmia, initiating application of the MVT to the musculature of the patient via the patient interface 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, and (c) thereafter allowed to relax, thereby achieving a forced hemodynamic output in the patient;

monitoring a hemodynamic condition of the patient via the patient interface;

computationally ascertaining an initial hemodynamic state of the patient based on the arrhythmia monitoring and the hemodynamic condition monitoring;

automatically adjusting the waveform parameters to establish a test hemodynamic condition in the patient as a response to the applied MVT, the test hemodynamic condition being associated with an expected hemodynamic state; and

computationally ascertaining a difference between the expected hemodynamic state and an actual physiologic state in the patient responsive to the hemodynamic condition, the difference being indicative of an ascertained patient condition.

15. The method of claim 14, further comprising:

automatically adjusting the waveform parameters to achieve a treatment objective for treating the ascertained patient condition.

16. The method of claim 14, wherein the waveform parameters adjusted to establish the test hemodynamic condition include waveform parameters to apply a relatively higher-intensity MVT to a first muscle group, and a relatively lower-intensity MVT to a second muscle group, wherein the ascertained patient condition represents an endurance of the patient to MVT.

17. The method of claim 14, wherein the test hemodynamic condition includes forced perfusion and forced ventilation, and wherein the ascertained patient condition includes a measure of respiration performance of the patient.

18. The method of claim 17, wherein in response to the ascertained patient condition, adjusting the increase in forced ventilation achieved by the MVT.

19. The method of claim 14, wherein the ascertained patient condition includes an indication of a relatively strong pulse and a relatively weak return, and wherein in response to the ascertained patient condition, the waveform parameters are adjusted to cause the MVT to prolong expansion of the chest cavity of the patient.

20. The method of claim 14, wherein in providing the plurality of electrodes, the plurality of electrodes includes electrodes positioned at various regions of the torso of the patient, and wherein initiation of the MVT includes selectively applying 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 a first muscle group and a second muscle group respectively correspond to different regions of the torso of the patient.

21. The method of claim 14, further comprising:

providing 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

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

targeting skeletal musculature at high intensity with the MVT as the time at which the HVT is to be applied approaches; and

thereafter, applying the HVT to the patient via the patient interface.

22. The method of claim 14, wherein monitoring the hemodynamic condition of the patient includes measuring at least one hemodynamic condition selected from the group consisting of:

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

23. The method of claim 14, wherein the ascertained patient condition includes an indication of a relatively weak pulse and a relatively strong return, and wherein in response to the ascertained patient condition, the waveform parameters are adjusted to cause the MVT to prolong contraction of the heart of the patient.

24. The method of claim 23, wherein adjustment of the waveform parameters includes delivering a first MVT waveform targeting a first muscle group immediately followed by a second MVT waveform targeting a second muscle group such that the musculature of the first muscle group and the second muscle group continuously maintain compression of the heart.