Medical monitoring and treatment device with external pacing

• US 9,675,804 B2
• Filed: 03/24/2016
• Issued: 06/13/2017
• Est. Priority Date: 05/31/2012
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Inventors: Kaib, Thomas E., Carlson, Rachel H., Frank, Gregory R., Whiting, Jason T.
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US15/079,294
• Publication Number:
  US 20160206886A1
• Time in Patent Office: 446 Days
• CPC Class Codes: A61B 2562/17 Comprising radiolucent components
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61N 1/046 Specially adapted for shock therapy, e.g. defibrillation
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

A non-invasive bodily-attached ambulatory medical monitoring and treatment device with pacing is provided. The device includes at least one therapy electrode; a memory storing information indicative of a patient'"'"'s cardiac activity; circuitry for implementing a plurality of pacing routines, each pacing routine of the plurality of pacing routines corresponding to at least one cardiac condition of a plurality of cardiac conditions; and at least one processor coupled to the circuitry and configured to identify, within the information, at least one cardiac condition of the plurality of cardiac conditions; and respond to the identified cardiac condition in part by causing execution of at least one pacing routine corresponding to the identified cardiac condition.

Claims

1. A non-invasive ambulatory medical monitoring and treatment device comprising:

a garment worn about a torso of a patient;

at least one therapy electrode disposed in the garment and configured to be in contact with the patient'"'"'s skin;

a plurality of ECG sensing electrodes disposed in the garment at a plurality of locations on the patient'"'"'s body;

a memory storing ECG information indicative of the patient'"'"'s cardiac activity, the ECG information obtained from the plurality of ECG sensing electrodes;

circuitry for implementing a plurality of pacing routines, each pacing routine of the plurality of pacing routines corresponding to at least one cardiac condition of a plurality of cardiac conditions; and

at least one processor coupled to the circuitry and configured to;

identify, within the ECG information, at least one cardiac condition of the plurality of cardiac conditions; and

respond to the identified cardiac condition in part by causing execution of at least one pacing routine corresponding to the identified cardiac condition.

2. The device of claim 1, wherein the identified cardiac condition includes bradycardia and the at least one pacing routine is configured to:

determine that a first interval has passed without detection of a heart beat; and

apply, responsive to determining that the first interval has passed, a pacing pulse via the at least one therapy electrode.

3. The device of claim 2, wherein the first interval is based on at least one of a base pacing rate and a hysteresis rate.

4. The device of claim 3, wherein the at least one pacing routine is further configured to:

detect an intrinsic heart beat prior to passage of a second interval;

determine a third interval based on the base pacing rate, the hysteresis rate, and a point where the intrinsic heart beat was detected; and

determine whether another intrinsic heart beat occurs within the third interval.

5. The device of claim 1, wherein the identified cardiac condition includes tachycardia and the at least one pacing routine comprises an anti-tachyarrhythmic pacing routine.

6. The device of claim 1, wherein the identified cardiac condition includes an erratic heart rate and the at least one pacing routine is configured to:

identify a first series of heart beats within the ECG information, the first series having a lower frequency;

identify a second series of heart beats within the ECG information, the second series having an upper frequency; and

apply, responsive to identifying the erratic heart rate, a series of pacing pulses via the at least one therapy electrode, the series of pacing pulses having a frequency above the lower frequency and below the upper frequency.

7. The device of claim 1, wherein the identified cardiac condition includes at least one of asystole and pulseless electrical activity and the at least one pacing routine is configured to:

determine that a first interval has passed without detection of a heart beat; and

apply, responsive to determining that the first interval has passed, a pacing pulse via the at least one therapy electrode.

8. The device of claim 7, wherein the at least one pacing routine is further configured to apply a defibrillating shock prior to applying the pacing pulse.

9. The device of claim 1, wherein the at least one pacing routine is further configured to:

determine whether the at least one pacing routine resulted in capture; and

adjust, responsive to determining that capture did not result, the characteristics of pacing pulses applied during subsequent executions of the at least one pacing routine.

10. The device of claim 1, wherein the at least one pacing routine is further configured to:

determine whether the at least one pacing routine resulted in capture; and

adjust, responsive to determining that capture did result, the characteristics of pacing pulses applied during subsequent executions of the at least one pacing routine.

11. The device according to claim 10, wherein the characteristics of the pacing pulses subject to adjustment include a pulse energy level, a pulse rate, and a pulse width.

12. A method of treating cardiac dysfunction using a non-invasive ambulatory medical monitoring and treatment device having at least one treatment electrode and implementing a plurality of pacing routines, the method comprising:

monitoring, by the non-invasive ambulatory medical monitoring and treatment device, information indicative of a patient'"'"'s cardiac condition;

identifying, by the non-invasive ambulatory medical monitoring and treatment device, within the information a cardiac condition from a plurality of cardiac conditions; and

responding to the identified cardiac condition at least in part by executing, by the non-invasive ambulatory medical monitoring and treatment device, at least one pacing routine of the plurality of pacing routines, the at least one pacing routine associated with the identified cardiac condition.

13. The method of claim 12, wherein the identified cardiac condition includes at least one of bradycardia and asystole.

14. A non-invasive ambulatory medical monitoring and treatment device comprising:

at least one therapy electrode;

at least one ECG sensing electrode;

a memory storing ECG information indicative of a patient'"'"'s cardiac activity, the ECG information obtained from the at least one ECG sensing electrode;

circuitry for implementing at least one pacing routine corresponding to a cardiac condition; and

at least one processor coupled to the circuitry and configured to;

identify, within the ECG information, the cardiac condition;

execute the at least one pacing routine corresponding to the identified cardiac condition, the at least one pacing routine including at least one pacing pulse to be applied via the at least one therapy electrode;

determine whether the at least one pacing routine resulted in capture at least in part based on the ECG information; and

adjust, responsive to determining that capture did not result, at least one characteristic of at least one pacing pulse applied during subsequent execution of the at least one pacing routine.

15. The device of claim 14, wherein the identified cardiac condition includes at least one of bradycardia, tachycardia, erratic heart rate, asystole, and pulseless electrical activity.

16. The device of claim 14, wherein the at least one processor is further configured to:

adjust, responsive to determining that capture did result, the characteristics of pacing pulses applied during subsequent executions of the at least one pacing routine to lessen a discomfort level experienced by a patient.

17. The device of claim 14, wherein the characteristics of the pacing pulses subject to adjustment include a pulse energy level, a pulse rate, and a pulse width.

18. The device of claim 14, wherein the at least one processor is further configured to process the ECG information to detect ventricular depolarization.

19. The device of claim 14, wherein determining whether the at least one pacing routine resulted in capture comprises causing the at least one processor to:

blank out ECG information signals being received via the ECG sensing electrode during a blanking interval in which at the least one pacing pulse is applied; and

detect cardiac activity immediately following the blanking interval.

20. The device of claim 19, wherein causing the at least one processor to detect cardiac activity comprises causing the at least one processor to detect intrinsic cardiac activity.

21. The device of claim 14, wherein determining whether the at least one pacing routine resulted in capture comprises causing the at least one processor to:

blank out ECG information signals being received via the ECG sensing electrode during a blanking interval in which at the least one pacing pulse is applied;

ignore ECG information signals being received via the ECG sensing electrode during a refractory interval following the blanking interval; and

detect cardiac activity immediately following the refractory interval.

22. The device of claim 21, wherein the blanking interval and the refractory interval are of substantially the same length.

23. The device of claim 21, wherein the at least one pacing pulse is a constant current pulse having a duration of 40 milliseconds, and wherein the blanking interval and the refractory interval have a combined duration of 45 milliseconds.

24. The device of claim 14, wherein the at least one processor is further configured to deliver another pacing pulse having an energy level higher than the at least one pacing pulse in response to determining that the at least one pacing pulse did not result in capture.

25. The device of claim 14, wherein the at least one processor is further configured to deliver another pacing pulse having an energy level lower than the at least one pacing pulse in response to determining that the at least one pacing pulse resulted in capture.

26. The device of claim 14, wherein the identified cardiac condition includes bradycardia and the at least one processor is configured to:

determine that a first interval has passed without detection of a heart beat; and

apply, responsive to determining that the first interval has passed, a pacing pulse via the at least one therapy electrode.

27. The device of claim 14, wherein the identified cardiac condition includes tachycardia and the at least one pacing routine comprises an anti-tachyarrhythmic pacing routine.

28. The device of claim 14, wherein the identified cardiac condition includes at least one of asystole and pulseless electrical activity and the at least one processor is configured to:

determine that a first interval has passed without detection of a heart beat; and

apply, responsive to determining that the first interval has passed, a pacing pulse via the at least one therapy electrode.