MEDICAL DEVICE CONFIGURED TO TEST FOR USER RESPONSIVENESS

• US 20130013014A1
• Filed: 09/12/2012
• Published: 01/10/2013
• 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
• Granted Patent: US 9,370,666 B2
• Time in Patent Office: Days
• US Class Current: 607/7
• 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 wearing the wearable defibrillator, the at least one response mechanism including a detector to detect a signal received from a body of the patient wearing the wearable defibrillator during actuation of the at least one response mechanism by the patient wearing the wearable defibrillator; and

at least one controller operatively connected to the at least one sensing electrode, the at least one treatment electrode, and the at least one response mechanism, the at least one controller being configured to receive the detected signal and verify that the patient wearing the wearable defibrillator actuated the at least one response mechanism based at least in part on the detected signal received by the detector during the actuation of the at least one response mechanism.

2. The wearable defibrillator of claim 1, further comprising:

a signal generator operatively connected to at the at least one controller and the at least one treatment electrode, the signal generator being configured to generate a marker signal that is transmitted into the body of the patient wearing the wearable defibrillator via the at least one treatment electrode;

wherein the at least one controller is configured to receive the marker signal detected by the detector and verify that the patient wearing the wearable defibrillator actuated the at least one response mechanism based at least in part on the detected marker signal received by the detector during the actuation of the at least one response mechanism.

3. The wearable defibrillator of claim 2, wherein the marker signal includes encoded information that is unique to at least one of the patient and the wearable defibrillator being worn by the patient.

4. The wearable defibrillator of claim 2, wherein the marker signal has electrical characteristics that do not interfere with the electrocardiogram signal of the patient.

5. The wearable defibrillator of claim 2, wherein the at least one sensing electrode includes a plurality of sensing electrodes configured to sense the electrocardiogram signal of the patient wearing the wearable defibrillator and further configured to sense the marker signal, and wherein the at least one controller is further configured to receive the marker signal sensed by each of the plurality of sensing electrodes and to determine that a respective sensing electrode of the plurality of sensing electrodes has become disconnected from the body of the patient in response to the marker signal not being sensed by the respective sensing electrode.

6. The wearable defibrillator of claim 1, wherein the detector is configured to detect a capacitance of a person during the actuation of the at least one response mechanism, and wherein the at least one controller is configured to receive the detected capacitance and verify that the patient wearing the wearable defibrillator is the person that actuated the at least one response mechanism based at least in part on the detected capacitance.

7. The wearable defibrillator of claim 6, wherein the at least one controller is configured to compare the detected capacitance to a range of capacitance values of the patient and to verify that the patient wearing the wearable defibrillator is the person that actuated the at least one response mechanism based at least in part on the comparison.

8. The wearable defibrillator of claim 1, wherein the detector is configured to detect an electrocardiogram signal of a person during the actuation of the at least one response mechanism and wherein the at least one controller is further configured to verify that the patient wearing the wearable defibrillator is the person that actuated the at least one response mechanism based at least in part on the electrocardiogram signal of the person.

9. The wearable defibrillator of claim 8, wherein the at least one controller is configured to compare the electrocardiogram signal of the patient wearing the wearable defibrillator with the electrocardiogram signal of the person during the actuation of the at least one response mechanism to verify that the patient wearing the wearable defibrillator is the person that actuated the at least one response mechanism based at least in part on the comparison.

10. The wearable defibrillator of claim 9, wherein the at least one controller is configured to compare the electrocardiogram signal of the patient wearing the wearable defibrillator with the electrocardiogram signal of the person during the actuation of the at least one response mechanism utilizing at least one of morphology comparisons, rate comparisons, and R-wave synchronizations.

11. The wearable defibrillator of claim 1, wherein the at least one controller is further configured to one of delay and withhold treatment to the patient wearing the wearable defibrillator responsive to verifying that the patient wearing the wearable defibrillator actuated the at least one response mechanism.

12. The wearable defibrillator of claim 11, wherein the at least one controller is further configured to issue at least one of visual and audible instructions to a person that actuated the at least one response mechanism in response to the detector not receiving the detected signal during the actuation of the at least one response mechanism.

13. The wearable defibrillator of claim 1, wherein the at least one controller is further configured to issue at least one of visual and audible instructions to a person that actuated the at least one response mechanism in response to the detector not receiving the detected signal during the actuation of the at least one response mechanism.

14. The wearable defibrillator of claim 1, further comprising at least one accessory item configured to be worn by the patient and to transmit an identification signal;

wherein the at least one controller is further configured to receive the identification signal from the at least one accessory item and verify that the patient wearing the wearable defibrillator actuated the at least one response mechanism based at least in part on the detected signal received by the detector during the actuation of the at least one response mechanism and the received identification signal.

15. The wearable defibrillator of claim 14, wherein the at least one accessory item includes at least one of a ring, a badge, and a bracelet.

16. The wearable defibrillator of claim 1, further comprising:

at least one accessory item configured to be worn by the patient;

wherein the at least one controller includes a magnetic proximity detector configured to detect whether the at least one accessory item is within a determined distance of the at least one controller and verify that the patient wearing the wearable defibrillator actuated the at least one response mechanism based at least in part on the detected signal received by the detector during the actuation of the at least one response mechanism and the at least one accessory item being within the determined distance.

17. A method of testing for responsiveness of a patient wearing a medical device, comprising:

sensing a medical condition of the patient using sensors on the medical device;

determining, in the medical device, whether the patient is in need of medical treatment based on the sensed medical condition;

issuing, responsive to a determination that the patient is in need of medical treatment, a prompt from the medical device that is directed to the patient to elicit a manual response; and

detecting, in the medical device, at least one signal received during the manual response to verify that the patient wearing the medical device provided the manual response.

18. The method of claim 17, further comprising:

transmitting a marker signal from the medical device into a body of the patient;

wherein detecting the at least one signal includes detecting, in the medical device, the marker signal received from the body of the patient during the manual response to verify that the patient wearing the medical device provided the manual response.

19. The method of claim 17, wherein detecting the at least one signal includes detecting, in the medical device, a capacitance of a person providing the manual response and comparing the capacitance of the person providing the manual response to a stored capacitance of the patient to verify that the patient wearing the medical device provided the manual response.

20. The method of claim 17, wherein sensing the medical condition of the patient includes sensing an electrocardiogram signal of the patient using electrocardiogram sensors on the medical device, and wherein detecting the at least one signal includes detecting, in the medical device, an electrocardiogram signal of a person providing the manual response and comparing the electrocardiogram signal of the person providing the manual response to the electrocardiogram signal of the patient to verify that the patient wearing the medical device provided the manual response.