Medical device configured to test for user responsiveness

• US 10,434,321 B2
• Filed: 07/08/2016
• Issued: 10/08/2019
• 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): D Abreu, Michael J
• Application Number:
  US15/205,542
• Publication Number:
  US 20160317826A1
• Time in Patent Office: 1,187 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 configured to deliver therapy to a patient, the wearable defibrillator comprising:

electrocardiogram sensing electrodes configured to sense an electrocardiogram signal of the patient wearing the wearable defibrillator;

therapy electrodes configured to provide a defibrillation treatment to the patient wearing the wearable defibrillator based on the sensed electrocardiogram signal;

a housing;

a response mechanism comprising a single response button or switch located on a portion of the housing and configured to be actuated by the patient in a predetermined sequence and within a certain time interval to generate a signal comprising an indication that the single response button or switch has been actuated in the predetermined sequence and within the certain time interval, the response mechanism comprising the single response button or switch are located on the housing so as to avoid accidental activation of the single response button or switch; and

at least one controller disposed within the housing and operatively connected to the electrocardiogram sensing electrodes, the therapy electrodes, and the single response button or switch, the at least one controller being configured to

detect a cardiac arrhythmia based on the electrocardiogram signal of the patient wearing the wearable defibrillator,

issue an alarm based on the detected cardiac arrhythmia,

activate the defibrillation treatment via the therapy electrodes to the patient wearing the wearable defibrillator in response to expiration of a first time interval following the issuance of the alarm,

receive the signal comprising the indication that the single response button or switch has been actuated in the predetermined sequence and within the certain time interval, and

at least one of delay and withhold the defibrillation treatment to the patient wearing the wearable defibrillator in response to receiving the signal comprising the indication that the single response button or switch has been actuated in the predetermined sequence and within the certain time interval;

wherein the predetermined sequence comprises

a first movement by the patient of the single response button or switch from a first position to a second position and

a second movement by the patient of the single response button or switch from the second position back to the first position within the certain time interval, the certain time interval being less than the first time interval.

2. The wearable defibrillator of claim 1, further comprising at least one of an audio speaker and a display that is at least one of located on or in the housing and located in another device.

3. The wearable defibrillator of claim 2, wherein the at least one controller is configured to provide at least one of audible instructions and visual instructions to at least one of the patient and any persons other than the patient that are located near the patient prior to activating the defibrillation treatment via the therapy electrodes to the patient wearing the wearable defibrillator.

4. The wearable defibrillator of claim 3, wherein the at least one of audible instructions and visual instructions include instructions that at least one of:

indicate that the defibrillation treatment is about to be provided to the patient wearing the wearable defibrillator; and

warn the any persons other than the patient that are located near the patient to move away from the patient.

5. The wearable defibrillator of claim 1, further comprising at least one of an audio speaker and a display that is at least one of located on or in the housing and located in another device.

6. The wearable defibrillator of claim 5, wherein the single response button or switch is wirelessly connected to the at least one controller.

7. The wearable defibrillator of claim 1, wherein the single response button or switch is wirelessly connected to the at least one controller.

8. The wearable defibrillator of claim 1, wherein the at least one controller is configured to provide at least one of audible instructions and visual instructions to at least one of the patient and any persons other than the patient that are located near the patient prior to activating the defibrillation treatment via the therapy electrodes to the patient wearing the wearable defibrillator.

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

10. The wearable defibrillator of claim 1, wherein the wearable defibrillator is configured to at least one of withhold and delay the defibrillation treatment to the patient wearing the wearable defibrillator in response to verifying that the patient wearing the wearable defibrillator had physical contact with the single response button or switch during actuation of the single response button or switch in the predetermined sequence and within the certain time interval.

11. The wearable defibrillator of claim 1, wherein the single response button or switch is located in a recessed portion of the housing.

12. The wearable defibrillator of claim 1, wherein the single response button or switch is located under a latch or cover that is moveably connected to the housing.