Medical device configured to test for user responsiveness

• US 10,328,275 B2
• Filed: 10/06/2015
• Issued: 06/25/2019
• Est. Priority Date: 06/07/2007
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Inventors: Donnelly, Edward J., Clark, John G., Szymkiewicz, Steven J., Kaib, Thomas E., Linder, Marshal W.
• Primary Examiner(s): Abreu, Michael J D
• Application Number:
  US14/876,322
• Publication Number:
  US 20160023014A1
• Time in Patent Office: 1,358 Days
• 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 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/3904 External heart defibrillators [EHD]
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock
• CPC Class Codes: A61N 1/3993 User interfaces for automatic external defibrillators

Abstract

A medical device is disclosed that includes one or more treatment electrodes, one or more sensors, and one or more controllers connected to the one or more treatment electrodes and one or more sensors. The medical device also includes one or more response mechanisms connected to the one or more controllers. The one or more controllers are configured to receive input from the one or more response mechanism and are also configured to determine whether a patient wearing the medical device actuated the one or more response mechanisms based, at least in part, on the input received from the one or more response mechanisms. In some disclosed embodiments, the medical device is a wearable defibrillator.

Claims

1. A wearable defibrillator comprising:

at least one sensing electrode configured to sense an electrocardiogram signal of a patient wearing the wearable defibrillator;

at least one treatment electrode configured to provide treatment to the patient wearing the wearable defibrillator;

at least one response mechanism configured to be actuated by the patient; and

at least one controller operatively connected to the at least one sensing electrode and the at least one treatment electrode and wirelessly connected to the at least one response mechanism, the at least one controller being configured to

receive the electrocardiogram signal of the patient,

determine, based on at least the electrocardiogram signal of the patient, whether the patient is experiencing a cardiac arrhythmia,

provide at least one prompt to elicit a response from the patient in response to determining that the patient is experiencing the cardiac arrhythmia,

provide treatment to the patient via the at least one treatment electrode in response to determining that the patient is experiencing the cardiac arrhythmia and the at least one response mechanism has not been actuated, and

withhold treatment to the patient via the at least one treatment electrode in response to the patient actuating the at least one response mechanism.

2. The wearable defibrillator of claim 1, wherein the wearable defibrillator is configured to be worn as at least one of a harness, belt, and vest.

3. The wearable defibrillator of claim 2, wherein the at least one response mechanism is configured to be disposed within a pocket of an article of clothing worn by the patient.

4. The wearable defibrillator of claim 3, wherein the at least one response mechanism includes at least one button.

5. The wearable defibrillator of claim 4, wherein the at least one button is sized and configured to avoid accidental activation by the patient.

6. The wearable defibrillator of claim 1, further comprising at least one of a display and a speaker operatively connected to the at least one controller.

7. The wearable defibrillator of claim 6, wherein the at least one prompt is at least one of an audible prompt and a visual prompt.

8. The wearable defibrillator of claim 6, wherein the at least one of the display and the speaker is located on or in a housing of the at least one controller.

9. The wearable defibrillator of claim 6, wherein the at least one of the display and the speaker is located in a device that is separate from the at least one controller.

10. The wearable defibrillator of claim 1, wherein the at least one sensing electrode is wirelessly connected to the at least one controller.

11. The wearable defibrillator of claim 10, wherein the at least one treatment electrode is wirelessly connected to the at least one controller.

12. The wearable defibrillator of claim 1, wherein the at least one prompt is a first prompt, and wherein the at least one controller is further configured to provide at least one additional prompt directed to at least one of the patient and a bystander in response to determining that the patient is experiencing the cardiac arrhythmia and the at least one response mechanism has not been actuated.

13. The wearable defibrillator of claim 12, wherein the at least one additional prompt indicates that treatment will soon be provided to the patient wearing the wearable defibrillator via the at least one treatment electrode.

14. The wearable defibrillator of claim 1, wherein the at least one response mechanism is configured to be disposed within a pocket of an article of clothing worn by the patient.

15. The wearable defibrillator of claim 1, wherein the at least one response mechanism includes a touch sensor.

16. The wearable defibrillator of claim 1, wherein the at least one prompt is at least one of an audible prompt and a visual prompt.

17. The wearable defibrillator of claim 1, further comprising at least one additional sensor operatively connected to the at least one controller, the at least one additional sensor including at least one of a motion detector, a position detector, and an oximetry detector.

18. The wearable defibrillator of claim 1, wherein the at least one response mechanism includes at least one button.

19. The wearable defibrillator of claim 18, wherein the at least one button is sized and configured to avoid accidental activation by the patient.

20. The wearable defibrillator of claim 19, wherein the at least one sensing electrode is wirelessly connected to the at least one controller.

21. The wearable defibrillator of claim 20, wherein the at least one treatment electrode is wirelessly connected to the at least one controller.

22. A wearable defibrillator system, comprising:

at least one of a harness, vest, and belt configured to be worn by a patient;

at least one sensing electrode configured to sense an electrocardiogram signal of the patient;

at least one treatment electrode disposed in the at least one of the harness, vest, and belt, the at least one treatment electrode configured to provide treatment to the patient;

at least one controller operatively connected to the at least one sensing electrode and the at least one treatment electrode, the at least one controller being configured

to receive the electrocardiogram signal of the patient,

to determine, based on at least the electrocardiogram signal of the patient, whether the patient is experiencing a cardiac arrhythmia, and

to provide at least one prompt to elicit a response from the patient in response to determining that the patient is experiencing the cardiac arrhythmia; and

a response device configured to wirelessly communicate with the at least one controller to cause the at least one controller to withhold treatment to the patient via the at least one treatment electrode in response to input from the patient.

23. The wearable defibrillator system of claim 22, further comprising at least one of a display and a speaker operatively connected to the at least one controller, and wherein the at least one prompt is at least one of an audible prompt and a visual prompt.

24. The wearable defibrillator system of claim 22, wherein the response device includes at least one button configured to receive the input from the patient, and the at least one button is sized and configured to avoid accidental activation by the patient.

25. The wearable defibrillator system of claim 22, wherein the at least one sensing electrode is wirelessly connected to the at least one controller.

26. A method of testing responsiveness of a patient wearing a defibrillator comprising:

sensing an electrocardiogram signal of the patient wearing the defibrillator;

determining whether the patient is experiencing a cardiac arrhythmia based on at least the electrocardiogram signal of the patient;

providing at least one prompt to elicit a response from the patient in response to determining that the patient is experiencing the cardiac arrhythmia;

providing treatment to the patient via at least one treatment electrode in response to determining that the patient is experiencing the cardiac arrhythmia and that no response is provided; and

wirelessly communicating the response to at least one controller of the defibrillator to cause the defibrillator to withhold treatment to the patient via the at least one treatment electrode in response to the patient providing the response.

27. The method of claim 26, wherein providing the at least one prompt includes providing at least one of an audible prompt and a visual prompt.