EXTERNAL CARDIAC STIMULATION PATCH

• US 20100249860A1
• Filed: 03/09/2010
• Published: 09/30/2010
• Est. Priority Date: 03/24/2009
• Status: Abandoned Application

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Esler, James A., Mokelke, Eric A., Shuros, Allan C.
• Application Number:
  US12/720,246
• Publication Number:
  US 20100249860A1
• Time in Patent Office: Days
• US Class Current: 607/4
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• 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

An external cardiac stimulation patch integrates a transcutaneous cardiac stimulation device and body-surface electrodes with a skin patch. The skin patch is to be attached onto a patient to provide for electrical contacts between the body-surface electrodes and a patient. The transcutaneous cardiac stimulation device delivers pacing pulses to the heart of the patient through pacing electrodes selected from the body-surface electrodes.

Claims

1. A system for pacing a heart having a myocardium in a living body having a skin, the system comprising:

a transcutaneous cardiac stimulation device including;

a pacing output circuit configured to produce pacing pulses suitable for capturing the heart by transcutaneous delivery; and

a pacing control circuit coupled to the pacing output circuit and configured to control the transcutaneous delivery of the pacing pulses;

a plurality of body-surface electrodes including a pacing electrode set electrically wired to the pacing output circuit, the pacing electrode set including at least two electrodes through which the pacing pulses are transcutaneously delivered to the heart; and

a skin patch integrated with the transcutaneous cardiac stimulation device and the plurality of body-surface electrodes, the skin patch configured to be attached onto the skin such that electrical contacts between the pacing electrode set and the body allow for effective transcutaneous delivery of the pacing pulses to the heart.

2. The system of claim 1, wherein the skin patch comprises an attachment surface and an adhesive layer on the attachment surface, the attachment surface configured to be in contact with the skin through the adhesive layer during the transcutaneous delivery of the pacing pulses.

3. The system of claim 1, wherein the skin patch comprises means for pressing the body-surface electrodes against the skin to ensure that the electrical contacts between the pacing electrode set and the body allow for the effective transcutaneous delivery of the pacing pulses to the heart.

4. The system of claim 1, wherein the pacing control circuit is configured to control the transcutaneous delivery of the pacing pulses by automatically executing a pacing protocol, the pacing control circuit including a pacing protocol module and the pacing protocol stored in the pacing protocol module, the pacing protocol including a cardioprotective pacing protocol adapted to augment mechanical stress on the myocardium to a level effecting cardioprotection against myocardial injury using the pacing pulses.

5. The system of claim 4, wherein the pacing protocol comprises a cardioprotective pacing protocol specifying a pacing sequence including a specified number of cycles of alternating pacing and non-pacing periods, the pacing periods each specified as a pacing duration during which pacing pulses are programmed to be delivered, the non-pacing periods each specified as a non-pacing duration during which none of the pacing pulses is programmed to be delivered.

6. The system of claim 4, wherein the transcutaneous cardiac stimulation device comprises a monitoring circuit including a hemodynamic sensing circuit configured to sense an impedance signal indicative of hemodynamic performance using electrodes selected from the plurality of body-surface electrodes, and the pacing control circuit is configured to adjust the transcutaneous delivery of the pacing pulses using the sensed impedance signal.

7. The system of claim 4, wherein the transcutaneous cardiac stimulation device comprises a monitoring circuit including an electrocardiogram (ECG) amplifier circuit configured to sense one or more ECG signals using electrodes selected from the plurality of body-surface electrodes.

8. The system of claim 7, wherein the monitoring circuit comprises a capture verification circuit configured to determine whether each of the pacing pulses results in a cardiac depolarization and produce a capture verification signal indicative of a percentage of the pacing pulses resulting in the cardiac depolarizations.

9. The system of claim 8, wherein the pacing control circuit comprises one or more of:

a pacing energy adjustment module configured to adjust a pacing energy associated with the pacing pulses using the capture verification signal; and

an electrode selection module configured to select the pacing electrode set from the plurality of body-surface electrodes and adjust the selection of the pacing electrode set using the capture verification signal.

10. The system of claim 8, comprising an accelerometer integrated with the skin patch and configured to sense an acceleration signal indicative of a level of skeletal muscle contractions resulting from the pacing pulses delivered through the pacing electrode set, and wherein the pacing control circuit is configured to adjust the transcutaneous delivery of the pacing pulses using the capture verification signal and the acceleration signal.

11. The system of claim 7, wherein the monitoring circuit comprises an ischemia detection circuit configured to detect an ischemia event using the one or more ECG signals and produce an ischemia signal indicative of a detection of the ischemia event, and the pacing control circuit is configured to control the transcutaneous delivery of the pacing pulses using the ischemia signal.

12. The system of claim 11, wherein the ischemia detection circuit is configured to locate an ischemic region in the heart using a plurality of ECG signals sensed through a plurality of electrode pairs selected from the plurality of body-surface electrodes and produce an ischemia signal indicative of an approximate location of the ischemic region, and the pacing control circuit is configured to select the pacing electrode set from the plurality of body-surface electrodes based on the approximate location of the ischemic region.

13. The system of claim 4, wherein the pacing control circuit is configured to start executing the cardioprotective pacing protocol in response to a cardioprotective pacing command, and the transcutaneous cardiac stimulation device comprises a user interface configured to allow for starting, stopping, and adjusting the transcutaneous delivery of the pacing pulses, the user interface including a cardioprotective pacing button configured to receive the cardioprotective pacing command.

14. The system of claim 13, wherein the transcutaneous cardiac stimulation device comprises:

a defibrillation output circuit configured to deliver defibrillation pulses suitable for defibrillating the heart by transcutaneous delivery through a defibrillation electrode set including at least two electrodes selected from the plurality of body-surface electrodes; and

a defibrillation control circuit configured to control the delivery of the defibrillation pulses in response to a defibrillation command,

and wherein the user interface comprises a defibrillation button configured to receive the defibrillation command.

15. The system of claim 14, wherein the transcutaneous cardiac stimulation device comprises a tachyarrhythmia detection circuit configured to detect a specified type tachyarrhythmia and generate a tachyarrhythmia detection signal indicative of a detection of the specified type tachyarrhythmia, and wherein the defibrillation control circuit is configured to control the delivery of the defibrillation pulses in response to one of the defibrillation command and the tachyarrhythmia detection signal, and the pacing control circuit is configured to stop executing the pacing protocol in response to the one of the defibrillation command and the tachyarrhythmia detection signal.

16. A method for pacing a heart having a myocardium in a living body having a skin, the method comprising:

delivering pacing pulses transcutaneously to the heart from a transcutaneous cardiac stimulation device integrated with a skin patch through a pacing electrode set including two or more electrodes selected from a plurality of body-surface electrodes integrated with the skin patch, wherein the skin patch is attached onto the skin such that electrical contacts between the pacing electrode set and the body allow for effective transcutaneous delivery of the pacing pulses to the heart.

17. The method of claim 16, comprising attaching the skin patch onto the skin using an adhesive.

18. The method of claim 16, comprising attaching the skin patch onto the skin using one or more belts or straps.

19. The method of claim 16, comprising controlling the delivery of the pacing pulses by executing a cardioprotective pacing protocol adapted to augment mechanical stress on the myocardium to a level effecting cardioprotection against myocardial injury using the pacing pulses.

20. The method of claim 19, comprising:

sensing one or more electrocardiogram (ECG) signals using a monitoring electrode set including two or more electrodes selected from the plurality of body-surface electrodes;

determining whether each of the pacing pulses delivered through the pacing electrode set results in a cardiac depolarization using the one or more ECG signals;

producing a capture verification signal indicative of whether the each of the pacing pulses delivered through the pacing electrode set results in the cardiac depolarization; and

adjusting the delivery of the pacing pulses using the capture verification signal.

21. The method of claim 20, comprising receiving a muscular stimulation signal indicative of skeletal muscular contractions resulting from the pacing pulses, and adjusting the delivery of the pacing pulses using the capture verification signal and the muscular stimulation signal.

22. The method of claim 20, comprising:

detecting a specified type tachyarrhythmia using the one or more ECG signals;

stopping the execution of the cardioprotective pacing protocol in response to a detection of the specified type tachyarrhythmia; and

delivering a defibrillation pulse to the heart using a defibrillation electrode set including at least two defibrillation electrodes selected from the plurality of body-surface electrodes in response to the detection of the specified type tachyarrhythmia.

23. The method of claim 19, comprising:

locating an ischemic region in the heart;

producing an ischemia signal indicative of an approximate location of the ischemic region; and

controlling the delivery of the pacing pulses using the ischemia signal.

24. The method of claim 23, comprising selecting the pacing electrode set from the plurality of body-surface electrodes using the ischemic signal.

25. The method of claim 19, wherein executing the cardioprotective pacing protocol comprises delivering the pacing pulses according to a pacing sequence including a specified number of cycles of alternating pacing and non-pacing periods, the pacing periods each specified as a pacing duration during which pacing pulses are programmed to be delivered, the non-pacing periods each specified as a non-pacing duration during which none of the pacing pulses is programmed to be delivered.