Systems and methods of delivering therapy using an ambulatory medical device

• US 10,806,940 B2
• Filed: 05/03/2018
• Issued: 10/20/2020
• 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:
  US15/970,125
• Publication Number:
  US 20180296847A1
• Time in Patent Office: 901 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 response mechanism comprising at least two buttons, wherein the response mechanism is configured to be activated by at least one of actuation of the at least two buttons and actuation of one of the at least two buttons;

a controller operatively connected with the 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 for activation of one of the at least two buttons of the response mechanism within at least one predetermined time period;

monitor for activation of two of the at least two buttons of the response mechanism within the at least one predetermined time period;

delay delivery of a therapy to the patient in response to detection of either

activation of the one of the at least two buttons of the response mechanism within the at least one predetermined time period, or

activation of the two of the at least two buttons of the response mechanism within the at least one predetermined time period; and

prepare to deliver the therapy to the patient in response to each of the at least two buttons of the response mechanism remaining in a deactivated state until expiration of the at least one predetermined time period.

2. The ambulatory medical device of claim 1, wherein the therapy manager component executable by the controller is configured to request an additional action be performed by the patient to verify patient responsiveness.

3. The ambulatory medical device of claim 2, wherein the requested additional action comprises releasing either the activated one of the at least two buttons or the activated two of the at least two buttons of the response mechanism.

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

monitor for activation of one of the at least two buttons of the response mechanism within a second predetermined time period;

monitor for activation of two of the at least two buttons of the response mechanism within the second predetermined time period;

request the patient release the one of the at least two buttons or release the two of the at least two buttons in response to detection of the activation of either the one of ef the at least two buttons or the activation of the two of the at least two buttons of the response mechanism remaining unchanged within the second predetermined time period; and

either further delay delivery of the therapy in response to detection of a release of the one of the at least two buttons or a release of the two of the at least two buttons of the response mechanism within the second predetermined time period or prepare to deliver the therapy to the patient in response to the activation of the one of the at least two buttons or the activation of the two of the at least two buttons of the response mechanism remaining unchanged until expiration of the second predetermined time period.

5. The ambulatory medical device of claim 4, wherein the second predetermined time period comprises a range of 25 seconds to 60 seconds.

6. The ambulatory medical device of claim 1, wherein the response mechanism is integrated with the controller.

7. The ambulatory medical device of claim 1, wherein the ambulatory medical device includes a touch screen integrated with the controller, and the response mechanism includes a button displayed on the touch screen.

8. The ambulatory medical device of claim 1, further comprising a garment worn about a torso of the patient.

9. The ambulatory medical device of claim 1, wherein the response mechanism is coupled with the controller.

10. 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.

11. The ambulatory medical device of claim 3, 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 release the one of the at least two buttons response buttons.

12. The ambulatory medical device of claim 1, further comprising at least one capacitor coupled to a power converter and wherein the therapy manager component is configured to prepare to deliver the therapy at least in part by directing the power converter to charge the at least one capacitor.

13. The ambulatory medical device of claim 1, further comprising at least one gel deployment device and wherein the therapy manager component is configured to prepare to deliver the therapy at least in part by directing the at least one gel deployment device to deploy gel.

14. The ambulatory medical device of claim 4, further comprising at least one therapy pad and wherein the therapy manager component is configured to provide at least one therapeutic shock to the patient via the at least one therapy pad in response to either the one of the at least two buttons or the two of the at least two buttons of the response mechanism remaining activated until expiration of the second predetermined time period.

15. The ambulatory medical device of claim 1, wherein the at least two buttons are on opposite sides of a housing of the ambulatory medical device.

16. The ambulatory medical device of claim 15, wherein the at least two buttons are recessed below a plane of an outer surface of the housing.

17. The ambulatory medical device of claim 1, wherein the at least two buttons are located adjacent each other on a housing of the ambulatory medical device.

18. The ambulatory medical device of claim 1, wherein the at least one processor is further configured to cause a speaker of the ambulatory medical device to communicate an audible alert to bystanders to not touch the patient prior to transmitting a defibrillating pulse of energy.

19. The ambulatory medical device of claim 1, further comprising a motion sensor or accelerometer through which patient activity may be monitored.

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

a response mechanism comprising at least two buttons, wherein the response mechanism is configured to be activated by at least one of actuation of the at least two buttons and actuation of one of the at least two buttons;

a controller operatively connected with the 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 for activation of one of the at least two buttons of the response mechanism within at least one predetermined time period;

monitor for activation of two of the at least two buttons of the response mechanism within the at least one predetermined time period;

delay delivery of a therapy to the patient in response to detection of either

activation of the one of the at least two buttons of the response mechanism within the at least one predetermined time period, or

activation of the two of the at least two buttons of the response mechanism within the at least one predetermined time period;

monitor for activation of one of the at least two buttons of the response mechanism within a second predetermined time period;

monitor for activation of two of the at least two buttons of the response mechanism within the second predetermined time period;

request the patient release the one of the at least two buttons or release the two of the at least two buttons in response to detection of the activation of either the one of the at least two buttons or the activation of the two of the at least two buttons of the response mechanism remaining unchanged within the second predetermined time period; and

either further delay delivery of the therapy in response to detection of a release of the one of the at least two buttons or a release of the two of the at least two buttons of the response mechanism within the second predetermined time period or prepare to deliver the therapy to the patient in response to the activation of the one of the at least two buttons or the activation of the two of the at least two buttons of the response mechanism remaining unchanged until expiration of the second predetermined time period.

21. The ambulatory medical device of claim 20, wherein the second predetermined time period comprises a range of 25 seconds to 60 seconds.

22. The ambulatory medical device of claim 20, wherein the therapy manager component is configured to notify the patient via at least one of audible, visual, and tactile output.

23. The ambulatory medical device of claim 20, 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 release the one of the at least two buttons or release the two of the at least two buttons.

24. The ambulatory medical device of claim 20, further comprising at least one capacitor coupled to a power converter and wherein the therapy manager component is configured to prepare to deliver the therapy at least in part by directing the power converter to charge the at least one capacitor.

25. The ambulatory medical device of claim 20, further comprising at least one gel deployment device and wherein the therapy manager component is configured to prepare to deliver the therapy at least in part by directing the at least one gel deployment device to deploy gel.

26. The ambulatory medical device of claim 20, wherein the at least two buttons are on opposite sides of a housing of the ambulatory medical device.

27. The ambulatory medical device of claim 20, wherein the at least two buttons are located adjacent each other on a housing of the ambulatory medical device.

28. The ambulatory medical device of claim 20, wherein the at least one processor is further configured to cause a speaker of the ambulatory medical device to communicate an audible alert to bystanders to not touch the patient prior to transmitting a defibrillating pulse of energy.