MEDICAL MONITORING AND TREATMENT DEVICE WITH EXTERNAL PACING

• US 20170296826A1
• Filed: 05/04/2017
• Published: 10/19/2017
• 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: Whiting, Jason T., Kaib, Thomas E., Carlson, Rachel H., Frank, Gregory R.
• Granted Patent: US 10,384,066 B2
• Time in Patent Office: 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; and

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

identify, within the ECG information, at least one cardiac condition;

detect whether the at least one cardiac condition comprises at least one of a ventricular fibrillation condition and a ventricular tachycardia condition, and responsive to detecting that the at least one cardiac condition comprises at least one of the ventricular fibrillation condition and the ventricular tachycardia condition, to respond to the identified at least one cardiac condition by causing the non-invasive ambulatory medical monitoring and treatment device to initiate a treatment sequence culminating in a delivery of one or more defibrillating shocks to the body of the patient; and

responsive to detecting that the at least one cardiac condition comprises one of a plurality of cardiac conditions associated with a predetermined plurality of pacing routines, to respond to the at least one cardiac condition in part by causing execution of at least one of the predetermined plurality of pacing routines corresponding to the identified at least one cardiac condition.

2. The non-invasive ambulatory medical monitoring and treatment device of claim 1, wherein the at least one therapy electrode includes a first therapy electrode disposed in the garment on a front of the patient'"'"'s torso and at least one second therapy electrode disposed on a back of the patient'"'"'s torso.

3. The non-invasive ambulatory medical monitoring and treatment device of claim 1, wherein the at least one therapy electrode includes a first therapy electrode and a second therapy electrode disposed on a front of the patient'"'"'s torso.

4. The non-invasive ambulatory medical monitoring and treatment device of claim 1, further comprising at least one additional sensor disposed in contact with the patient, the at least one additional sensor including at least one of a blood pressure sensor, a heart sounds sensor, a thoracic impedance sensor, a pulse oxygen sensor, a respiration sensor, and an activity level sensor.

5. The non-invasive ambulatory medical monitoring and treatment device of claim 1, wherein the plurality of cardiac conditions associated with the predetermined plurality of pacing routines includes bradycardia, tachycardia, erratic heart rate, asystole, and pulseless electrical activity.

6. The non-invasive ambulatory medical monitoring and treatment device of claim 5, wherein the predetermined plurality of pacing routines includes fixed rate and fixed energy pacing, adjustable rate pacing, and capture management pacing.

7. The non-invasive ambulatory medical monitoring and treatment device of claim 1, wherein the predetermined plurality of pacing routines includes fixed rate and fixed energy pacing, adjustable rate pacing, and capture management pacing.

8. The non-invasive ambulatory medical monitoring and treatment device of claim 1, wherein the at least one processor is further configured to detect a discomfort of the patient during the at least one pacing routine and adjust at least one characteristic of the at least one pacing routine in response to the detected discomfort of the patient, the at least one characteristic including at least one of an energy level of pacing pulses, a width of the pacing pulses, and a rate of the pacing pulses.

9. The non-invasive ambulatory medical monitoring and treatment device of claim 1, further comprising one or more actionable user interface elements that can be actuated by the patient to indicate that the patient is conscious and withhold the delivery of the one or more defibrillating shocks.

10. The non-invasive ambulatory medical monitoring and treatment device of claim 1, further comprising a communication interface to wirelessly communicate the stored ECG information to a computer network.

11. The non-invasive ambulatory medical monitoring and treatment device of claim 1, wherein the at least one processor is further configured to alert the patient and any bystanders to the at least one cardiac condition prior to initiating the treatment sequence culminating in the delivery of the one or more defibrillating shocks to the body of the patient.

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

monitoring information indicative of a patient'"'"'s cardiac condition obtained from the plurality of ECG sensing electrodes;

identifying, within the information, at least one cardiac condition;

determining whether the at least one cardiac condition corresponds to at least one of a ventricular fibrillation condition and a ventricular tachycardia condition;

initiating a treatment sequence culminating in a delivery of one or more defibrillating shocks to the body of the patient responsive to a determination that the at least one cardiac condition corresponds to at least one of the ventricular fibrillation condition and the ventricular tachycardia condition; and

executing at least one pacing routine of a predetermined plurality of pacing routines to apply pacing pulses to the body of the patient responsive to a determination that the at least one cardiac condition corresponds to one of a plurality of cardiac conditions associated with at least one of the predetermined plurality of pacing routines.

13. The method of claim 12, wherein the plurality of cardiac conditions associated with at least one of the predetermined plurality of pacing routines includes bradycardia, tachycardia, erratic heart rate, asystole, and pulseless electrical activity.

14. The method of claim 12, wherein the predetermined plurality of pacing routines includes fixed rate and fixed energy pacing, adjustable rate pacing and capture management pacing.

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

at least one therapy electrode configured to be in contact with a patient'"'"'s skin;

a plurality of ECG sensing electrodes disposed 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; and

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

identify, within the ECG information, at least one cardiac condition;

detect whether the at least one cardiac condition comprises at least one of a ventricular fibrillation condition and a ventricular tachycardia condition, and responsive to detecting that the at least one cardiac condition comprises at least one of the ventricular fibrillation condition and the ventricular tachycardia condition, to respond to the identified at least one cardiac condition by causing the non-invasive ambulatory medical monitoring and treatment device to initiate a treatment sequence culminating in a delivery of one or more defibrillating shocks to the body of the patient; and

responsive to detecting that the at least one cardiac condition comprises one of a plurality of cardiac conditions associated with a predetermined plurality of pacing routines, to respond to the at least one cardiac condition in part by causing execution of at least one of the predetermined plurality of pacing routines corresponding to the identified at least one cardiac condition.

16. The non-invasive ambulatory medical monitoring and treatment device of claim 15, wherein the plurality of ECG sensing electrodes are adhesive ECG sensing electrodes.

17. The non-invasive ambulatory medical monitoring and treatment device of claim 16, wherein the plurality of ECG sensing electrodes are wireless ECG sensing electrodes.

18. The non-invasive ambulatory medical monitoring and treatment device of claim 16, wherein the plurality of ECG sensing electrodes are long term wear adhesive ECG sensing electrodes configured to be worn continuously by the patient for an extended period of three or more days.

19. The non-invasive ambulatory medical monitoring and treatment device of claim 15, wherein the at least one therapy electrode includes at least two therapy electrodes, a first of the at least two therapy electrodes being configured to be disposed on a front of the patient'"'"'s torso.

20. The non-invasive ambulatory medical monitoring and treatment device of claim 15, wherein the plurality of cardiac conditions associated with the predetermined plurality of pacing routines includes bradycardia, tachycardia, erratic heart rate, asystole, and pulseless electrical activity.

21. The non-invasive ambulatory medical monitoring and treatment device of claim 20, wherein the predetermined plurality of pacing routines includes fixed rate and fixed energy pacing, adjustable rate pacing, and capture management pacing.