MEDICAL DEVICE CONFIGURED TO TEST FOR USER RESPONSIVENESS

• US 20160317826A1
• Filed: 07/08/2016
• Published: 11/03/2016
• 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.
• Granted Patent: US 10,434,321 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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:

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 based on the sensed electrocardiogram signal;

a single response button configured to be actuated in a predetermined sequence to generate a signal comprising an indication that the single response button has been actuated;

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

receive the signal comprising an indication that the single response button has been actuated, and

at least one of delay and withhold the treatment to the patient wearing the wearable defibrillator.

2. The wearable defibrillator of claim 1, wherein the predetermined sequence comprises the single response button being actuated at least twice within a predetermined time interval.

3. The wearable defibrillator of claim 2, wherein the predetermined sequence comprises a first movement of the single response button from a first position to a second position and a second movement of the single response button from the second position to the first position, the first movement and the second movement being within the predetermined time interval.

4. The wearable defibrillator of claim 2, wherein the single response button is configured to be actuated by at least two separate patient actions in the predetermined sequence.

5. The wearable defibrillator of claim 4, wherein the at least one controller is further configured to cause the at least one treatment electrode to provide treatment to the patient wearing the wearable defibrillator responsive to not receiving the signal.

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

7. The wearable defibrillator of claim 6, 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 causing the at least one treatment electrode to provide treatment to the patient wearing the wearable defibrillator.

8. The wearable defibrillator of claim 7, wherein the at least one of the audible instructions and the visual instructions include instructions that at least one of:

indicate that the 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.

9. 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 a housing of the at least one controller and located in another device.

10. The wearable defibrillator of claim 9, wherein the single response button is wirelessly connected to the at least one controller.

11. The wearable defibrillator of claim 1, wherein the single response button is located in a hidden location.

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

13. The wearable defibrillator of claim 1, wherein the at least one controller is further configured to cause the at least one treatment electrode to provide treatment to the patient wearing the wearable defibrillator responsive to not receiving the signal.

14. The wearable defibrillator of claim 13, further comprising at least one of an audio speaker and a display that is at least one of located on or in a housing of the at least one controller and located in another device.

15. The wearable defibrillator of claim 14, 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 causing the at least one treatment electrode to provide treatment to the patient wearing the wearable defibrillator.

16. 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.

17. The wearable defibrillator of claim 1, wherein the wearable defibrillator is configured to prevent rendering 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 during actuation of the single response button.

18. A method of determining responsiveness of a patient wearing a wearable defibrillator configured to deliver therapy to the patient, the method comprising:

sensing an electrocardiogram signal of a patient wearing the wearable defibrillator;

determining, based on the sensed electrocardiogram signal of the patient, whether treatment should be provided to the patient via at least one treatment electrode;

providing a prompt from the wearable defibrillator that is directed to the patient responsive to determining that treatment should be provided to the patient;

determining whether a single response button has been actuated in a predetermined sequence responsive to providing the prompt; and

at least one of delaying and withholding the treatment to the patient via the at least one treatment electrode in response to a determination that the single response button has been actuated in the predetermined sequence.

19. The method of claim 18, wherein the predetermined sequence comprises actuating the single response button at least twice within a predetermined time interval.

20. The method of claim 18, wherein the single response button is configured to be actuated by at least two separate patient actions in the predetermined sequence.

21. The method of claim 18, further comprising:

providing treatment to the patient via the at least one treatment electrode in response to a determination that the single response button has not been actuated in the predetermined sequence.

22. A wearable defibrillator configured to deliver therapy to a patient wearing the wearable defibrillator, the wearable defibrillator including a memory connected to at least one controller, the memory including a treatment algorithm stored therein that when executed causes the at least one controller to:

sense an electrocardiogram signal of the patient;

determine, based on the sensed electrocardiogram signal of the patient, whether treatment should be provided to the patient via at least one treatment electrode;

provide a prompt from the wearable defibrillator that is directed to the patient responsive to determining that treatment should be provided to the patient;

determine whether a single response button has been actuated in a predetermined sequence responsive to providing the prompt; and

at least one of delay and withhold the treatment to the patient via the at least one treatment electrode in response to a determination that the single response button has been actuated in the predetermined sequence.

23. The wearable defibrillator of claim 22, wherein the predetermined sequence comprises the patient actuating the single response button at least twice within a predetermined time interval.

24. The wearable defibrillator of claim 22, wherein the single response button is configured to be actuated by at least two separate patient actions in the predetermined sequence.