Systems and methods of delivering therapy using an ambulatory medical device

• US 9,987,497 B2
• Filed: 01/18/2017
• Issued: 06/05/2018
• Est. Priority Date: 06/28/2013
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Inventors: Kaib, Thomas E., Linder, Marshal W.
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US15/408,965
• Publication Number:
  US 20170251232A1
• Time in Patent Office: 503 Days
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/3931 Protecting, e.g. back-up systems
• 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

An ambulatory medical device capable of delivering therapy to a patient includes at least one response mechanism having a state capable of being activated by one response button; a controller operatively connected with the at least one response mechanism, the controller including at least one processor coupled with a memory; and a therapy manager component executable by the controller and configured to detect a physiological parameter having a value indicative of a health disorder of the patient, notify the patient of impending therapy delivery in response to the detection of the physiological parameter, monitor the state of each at least one response mechanism within at least one predetermined time period, and delay therapy delivery to the patient in response to detection of a change in the state in a single response mechanism of the at least one response mechanism within the at least one predetermined time period.

Claims

1. An ambulatory medical device capable of delivering therapy to a patient, the ambulatory medical device comprising:

a controller for controlling the delivery of the therapy to the patient, the controller including at least one processor coupled with a memory;

a user interface in wireless communication with the controller;

a response mechanism having a state that is activated by one response button disposed on the user interface; and

a therapy manager component executable by the controller and configured to;

detect a physiological parameter having a value indicative of a cardiac disorder of the patient;

notify the patient of impending therapy delivery in response to the detection of the physiological parameter;

request the patient to provide a first input to the ambulatory medical device via the response mechanism;

monitor the state of the response mechanism by detecting activation of the one response button within at least one predetermined time period;

delay therapy delivery to the patient in response to detecting a change in the state of the response mechanism by the activation of the one response button within the at least one predetermined time period;

monitor the state of the response mechanism for a second predetermined time period; and

request the patient to provide a second input to the ambulatory medical device via the response mechanism during the second predetermined time period.

2. The ambulatory medical device of claim 1, wherein the therapy manager component is further configured to:

either further delay the therapy delivery in response to detection of the second input during the second predetermined time period or prepare to deliver the therapy to the patient in response to not detecting the second input before expiration of the second predetermined time period.

3. The ambulatory medical device of claim 1, further comprising a touchscreen display disposed on the user interface.

4. The ambulatory medical device of claim 3, wherein the response mechanism comprises a button displayed on the touch screen and the state of the response mechanism is activated when the patient interacts with the button displayed on the touch screen.

5. The ambulatory medical device of claim 4, wherein at least one of the first input and the second input is provided via the button displayed on the touch screen.

6. The ambulatory medical device of claim 1, wherein the therapy manager component is configured to notify the patient via at least one of audible, visual, and tactile output.

7. The ambulatory medical device of claim 1, wherein the cardiac disorder comprises at least one of ventricular tachycardia, ventricular defibrillation, bradycardia, tachycardia, erratic heart rate, asystole, and pulseless electrical activity.

8. The ambulatory medical device of claim 1, wherein the therapy manager component is further configured to prepare to deliver the therapy to the patient by causing the ambulatory medical device to apply gel to the patient.

9. The ambulatory medical device of claim 1, wherein the therapy manager component is further configured to generate at least one of siren activity and vibration activity to accompany the request that the patient provide either or both the first input and the second input to the ambulatory medical device.

10. The ambulatory medical device of claim 1, wherein the user interface comprises two response buttons and the response mechanism comprises a state that is activated by either one of the two response buttons.

11. The ambulatory medical device of claim 1, further comprising at least one adhesive ECG sensing electrode coupled with the controller to monitor a cardiac function of the patient.

12. The ambulatory medical device of claim 1, further comprising a vest, and at least one adhesive ECG sensing electrode attached to the vest and disposed adjacent at least one location on a body of the patient.

13. The ambulatory medical device of claim 1, further comprising a first at least one ECG sensing electrode disposed on a front of a torso of the patient and a second at least one ECG sensing electrode disposed on a side of the torso of the patient.

14. The ambulatory medical device of claim 1, further comprising a plurality of physiological sensors including an ECG electrode and at least one of a body temperature sensor, a respiration monitor, and an acoustic sensor.

15. A method for delivering therapy to a patient using an ambulatory medical device comprising:

detecting, by a controller of the ambulatory medical device, a physiological parameter having a value indicative of a cardiac disorder of the patient;

notifying the patient of impending therapy delivery in response to the detection of the physiological parameter;

requesting the patient to provide a first input to the ambulatory medical device via a response mechanism having a state that is activated by one response button, the response mechanism being disposed on a user interface in wireless communication with the controller;

monitoring the state of the response mechanism by detecting the activation of the one response button within at least one predetermined time period;

delaying therapy delivery to the patient in response to detecting a change in the state of the response mechanism by the activation of the one response button within the at least one predetermined time period;

monitoring the state of the response mechanism for a second predetermined time period; and

requesting the patient to provide a second input to the ambulatory medical device via the response mechanism during the second predetermined time period.

16. The method of claim 15, further comprising either further delaying the delivery of the therapy in response to detection of the second input during the second predetermined time period or preparing to deliver the therapy to the patient in response to not detecting the second input before expiration of the second predetermined time period.

17. An ambulatory medical device capable of delivering therapy to a patient, the ambulatory medical device comprising:

a controller for controlling the delivery of the therapy to the patient, the controller including at least one processor coupled with a memory;

a garment configured to be worn on a torso of the patient;

a plurality of therapy electrodes disposed on the garment, coupled to the controller, and configured to deliver the therapy to the patient;

a plurality of ECG sensing electrodes disposed on the garment, coupled to the controller, and configured to monitor a cardiac function of the patient;

a user interface in wireless communication with the controller;

a response mechanism having a state that is activated by one response button disposed on the user interface; and

a therapy manager component executable by the controller and configured to;

detect a physiological parameter having a value indicative of a cardiac disorder of the patient;

notify the patient of impending therapy delivery in response to the detection of the physiological parameter;

request the patient to provide a first input to the ambulatory medical device via the response mechanism;

monitor the state of the response mechanism by detecting activation of the one response button within at least one predetermined time period;

delay therapy delivery to the patient in response to detecting a change in the state of the response mechanism by the activation of the one response button within the at least one predetermined time period;

monitor the state of the response mechanism for a second predetermined time period; and

request the patient to provide a second input to the ambulatory medical device via the response mechanism during the second predetermined time period.

18. The ambulatory medical device of claim 17, wherein the user interface comprises two response buttons and the response mechanism comprises a state that is activated by either one of the two response buttons.

19. The ambulatory medical device of claim 17, wherein a first at least one of the plurality of ECG sensing electrodes is disposed on a front of the torso of the patient, and a second at least one of the plurality of ECG sensing electrodes is disposed on a side of the torso of the patient.

20. The ambulatory medical device of claim 17, wherein the plurality of ECG sensing electrodes comprises a long term wear adhesive electrode.