Systems and methods of delivering therapy using an ambulatory medical device

• US 9,579,516 B2
• Filed: 06/27/2014
• Issued: 02/28/2017
• 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:
  US14/318,186
• Publication Number:
  US 20150039053A1
• Time in Patent Office: 977 Days
• US Class Current: 1/1
• 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 is provided. The ambulatory medical device comprises at least one controller operatively connected to at least one sensor configured to detect a health disorder of the patient, at least one treatment element configured to deliver therapy to the patient, and at least one response mechanism configured to be actuated by the patient, the at least one response mechanism having one of a first state and a second state. The at least one controller being configured to delay delivery of the therapy to patient for a first predetermined period of time responsive to detection of the health disorder and the at least one response mechanism having the first state, and to deliver the therapy to the patient in response to continued detection of the health disorder, the at least one response mechanism remaining in the first state.

Claims

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

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;

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;

monitor the state for a second predetermined time period;

request the patient change the state in response to detection of the state remaining unchanged during the second predetermined time period, the request comprising at least one of an audible and visual instruction to the patient to release the one response button; and

either further delay therapy delivery in response to detection of a change in the state during the second predetermined time period or prepare to deliver the therapy to the patient in response to the state remaining unchanged until expiration of the second predetermined time period.

2. The ambulatory medical device of claim 1, wherein the at least one response mechanism is integrated with the controller.

3. The ambulatory medical device of claim 1, wherein the ambulatory medical device includes a display integrated with the controller, and the one response button includes a button displayed on the display.

4. The ambulatory medical device of claim 1, wherein the at least one response mechanism includes a microphone, integrated with the controller, and wherein the therapy manager component is configured to delay therapy delivery to the patient in response to detection of a predetermined voice command within the at least one predetermined time period.

5. The ambulatory medical device of claim 1, wherein the at least one response mechanism is coupled with the controller.

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 health disorder includes 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 7, wherein the therapy manager component is further configured to further delay therapy delivery to the patient by further delaying therapy delivery for a duration that is greater for ventricular tachycardia than for ventricular defibrillation.

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

monitor a state of consciousness of the patient by monitoring patient motion; and

delay therapy delivery in response to detection of patient motion.

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

monitor patient motion to detect a patient fall event; and

prepare to deliver the therapy to the patient in response to detection of the patient fall event.

11. The ambulatory medical device of claim 1, wherein the therapy manager component is further configured to monitor the state of consciousness of the patient by monitoring respiration of the patient.

15. 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 turning on a converter to enable at least one capacitor to charge from a battery source in the ambulatory medical device.

16. 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.

17. The ambulatory medical device of claim 1, wherein the therapy manager component is further configured to deliver the therapy to the patient.

19. The ambulatory medical device of claim 1, wherein the single response mechanism is configured to be in at least one of an activated state and a deactivated state.

20. The ambulatory medical device of claim 19, wherein the therapy manager component is further configured to:

detect a cardiac arrhythmia event;

detect that the single response mechanism is in the activated state during the cardiac arrhythmia event;

request the patient change the state from the activated state to the deactivated state in response to detecting that the single response mechanism is in the activated state during the cardiac arrhythmia event; and

either further delay therapy delivery in response to detection of a change in the state of the single response mechanism or prepare to deliver the therapy to the patient in response to the state remaining unchanged during the at least one predetermined time period.

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

detect that the one response button is in a depressed state for longer than the at least one predetermined time period;

request that the patient release the one response button; and

prepare to deliver the therapy to the patient in response to the depressed state remaining unchanged until the expiration of the second predetermined time period.

22. The ambulatory medical device of claim 21, 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 response button.

23. The ambulatory medical device of claim 21, wherein the therapy manager component is further configured to detect that the one response button was in the depressed state at an onset of the health disorder of the patient.

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

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;

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;

monitor the state for a second predetermined time period;

request the patient change the state in response to detection of the state remaining unchanged during the second predetermined time period;

either further delay therapy delivery in response to detection of a change in the state during the second predetermined time period or prepare to deliver the therapy to the patient in response to the state remaining unchanged until expiration of the second predetermined time period;

detect that the one response button is in a depressed state for longer than the at least one predetermined time period;

request that the patient release the one response button; and

prepare to deliver the therapy to the patient in response to the depressed state remaining unchanged until expiration of the second predetermined time period.

13. The ambulatory medical device of claim 12, 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 response button.

14. The ambulatory medical device of claim 12, wherein the therapy manager component is further configured to detect that the one response button was in the depressed state at an onset of the health disorder of the patient.

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

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;

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;

monitor the state for a second predetermined time period;

request the patient change the state in response to detection of the state remaining unchanged during the second predetermined time period;

either further delay therapy delivery in response to detection of a change in the state during the second predetermined time period or prepare to deliver the therapy to the patient in response to the state remaining unchanged until expiration of the second predetermined time period;

monitor the state for a third predetermined time period following the expiration of the second predetermined time period;

request the patient change the state in response to detection of the state remaining unchanged during the third predetermined time period; and

either further delay therapy delivery in response to detection of a change in the state during the third predetermined time period or prepare to deliver the therapy to the patient in response to the state remaining unchanged until expiration of the third predetermined time period.