SYSTEMS AND METHODS OF DELIVERING THERAPY USING AN AMBULATORY MEDICAL DEVICE

• US 20150039053A1
• Filed: 06/27/2014
• Published: 02/05/2015
• 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.
• Granted Patent: US 9,579,516 B2
• Time in Patent Office: Days
• US Class Current: 607/60
• 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;

a controller remotely coupled 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 within at least one predetermined time period; and

delay therapy delivery to the patient in response to detection of a change in the state within the at least one predetermined time period.

2. The ambulatory medical device according to claim 1, wherein the ambulatory medical device further comprises:

at least one therapy pad coupled with the controller; and

at least one ECG sensor coupled with the controller.

7. The ambulatory medical device according to claim 1, wherein the ambulatory medical device includes a display coupled with the controller, and wherein the therapy manager component is further configured to display, via the display, at least one notification requesting that the patient change the state of the at least one response mechanism.

9. The ambulatory medical device according to claim 1, wherein the ambulatory medical device includes an audible alert unit coupled with the controller, and wherein the therapy manager component is further configured generate at least one audible alert to the patient via the audible alert unit.

10. The ambulatory medical device according to claim 9, wherein the audible alert comprises requesting the patient to change the state of the at least one response mechanism.

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

13. The ambulatory medical device according to claim 11, wherein the therapy manager component is further configured to delay the therapy delivery in response to detection of targeted patient motion.

14. The ambulatory medical device according to claim 11, wherein the therapy manager component is further configured to deliver therapy to the patient in response to detection of a patient fall.

15. The ambulatory medical device according to claim 1, wherein the ambulatory medical device includes a tactile stimulator coupled with the controller, and wherein the therapy manager component is configured to notify patient of the impending therapy delivery by vibrating the ambulatory medical device controller via the tactile stimulator.

16. The ambulatory medical device according to claim 1, wherein the therapy manager component is configured to delay the of therapy delivery for an interval of time selected based on a severity of the health disorder.

17. The ambulatory medical device according to claim 1, wherein the at least one response mechanism includes at least one response button operable to change the state of the at least one response mechanism.

18. The ambulatory medical device according to claim 17, wherein the at least one response mechanism has a deactivated state and an activated state;

and wherein the at least one response button is operable to change the state between the deactivated state and the activated state.

77. The ambulatory medical device according to claim 1, wherein the at least one response mechanism communicates wirelessly with the controller.

78. The ambulatory medical device according to claim 1, wherein the therapy manager component is configured to notify the patient by sending a wireless communication to computer enabled glasses.

79. The ambulatory medical device according to 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.

80. The ambulatory medical device according to claim 1, wherein the ambulatory medical device includes a display and the at least one response mechanism includes a button displayed on the display.

81. The ambulatory medical device according to claim 1, wherein the therapy manager component is configured to notify the patient at least in part by requesting that the patient change the state.

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

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

84. The ambulatory medical device according to claim 1, wherein the at least one predetermined time period is based on the health disorder of the patient.

85. The ambulatory medical device according to claim 1, wherein the at least one predetermined time period includes a first predetermined time period and a second predetermined time period following the first time period, and wherein notification of impending therapy delivery in the second predetermined time period is the same as during the first predetermined time period.

86. The ambulatory medical device according to claim 1, wherein the at least one predetermined time period includes a first predetermined time period and a second predetermined time period following the first time period, and wherein notification of impending therapy delivery in the second predetermined time period is different than during the first predetermined time period.

87. The ambulatory medical device according to claim 1, wherein the at least one predetermined time period includes a first predetermined time period, a second predetermined time period following the first time period, and a third predetermined time period following the second time period.

3-6. -6. (canceled)

8. (canceled)

12. (canceled)

19. A method of delivering therapy to a patient using an ambulatory medical device, the ambulatory medical device including a controller remotely coupled with at least one response mechanism having a state, the method comprising:

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

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

monitoring the state within at least one predetermined time period; and

delaying of therapy delivery to the patient in response to detecting a change in the state within the at least one predetermined time period.

20. The method according to claim 19, wherein the ambulatory medical device includes at least one electrocardiogram (ECG) sensor coupled with the controller;

and wherein detecting, by the ambulatory medical device, the physiological parameter includes detecting an ECG signal.

24. The method according to claim 19, wherein the ambulatory medical device includes a display coupled with the controller and wherein notifying the patient of impending therapy delivery includes displaying at least one notification requesting the patient change the state of the at least one response mechanism via the display.

26. The method according to claim 19, wherein the ambulatory medical device includes an audible alert unit coupled with the controller, and wherein notifying the patient of impending therapy delivery includes generating at least one audible alert to the patient via the audible alert unit.

27. The method according to claim 26, wherein delaying the therapy delivery to the patient includes generating at least one audible alert to the patient via the audible alert unit indicating a delay in therapy delivery.

28. The method according to claim 19, wherein the method further comprises monitoring a state of consciousness of the patient.

30. The method according to claim 28, wherein monitoring the state of consciousness of the patient includes monitoring patient motion.

31. The method according to claim 28, wherein the method further comprises delivering therapy to the patient in response to detecting a patient fall.

32. The method according to claim 19, wherein the ambulatory medical device includes a tactile stimulator coupled with the controller and wherein notifying the patient of impending therapy delivery includes vibrating the ambulatory medical device controller via the tactile stimulator.

33. The method according to claim 19, wherein delaying therapy delivery to the patient in response to detecting a change in the state includes delaying therapy delivery for a time interval selected based on a severity of the health disorder.

72. The method according to claim 19, further comprising providing an alert to the patient by at least one of glasses and an earpiece, the at least one of the glasses and the earpiece being communicatively coupled to the ambulatory medical device.

96. The method of claim 19, wherein the at least one response mechanism includes a microphone, integrated with the controller, and wherein the delaying therapy delivery to the patient includes delaying therapy deliver to the patient in response to detection of a predetermined voice command within the at least one predetermined time period.

21-23. -23. (canceled)

25. (canceled)

29. (canceled)

34. (canceled)

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

two or more response mechanisms each having a state;

a memory storing an active operation mode parameter identifying an active operation mode from a plurality of operation modes;

a controller operatively connected with the two or more response mechanisms, the controller including at least one processor coupled with the memory; and

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

identify the active operation mode from the plurality of operation modes;

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

request the patient change the state of one of the two or more response mechanisms in response to detection of the physiological parameter;

monitor the state of each of the two or more response mechanisms within a predetermined period; and

delay administration of therapy to the patient in response to detection of a change in the state of one of the two or more response mechanisms within the predetermined period and identification of a first mode as the active operation mode.

36. The ambulatory medical device according to claim 35, wherein the therapy manager component is further configured to:

request, in response to the detection the change, that the patient again change the state of one of the two or more response mechanisms; and

monitor the state of each of the two or more response mechanisms within an additional predetermined period, wherein the therapy manager component is configured to delay the administration of therapy by delaying, in response to the detection of a further change in the state within the additional predetermined period, the administration of therapy to the patient.

37. The ambulatory medical device according to claim 35, wherein the ambulatory medical device further comprises:

at least one therapy pad coupled with the controller; and

at least one ECG sensor coupled with the controller.

42. The ambulatory medical device according to claim 35, wherein the ambulatory medical device includes a display coupled with the controller and wherein the therapy manager component is further configured to display, via the display, at least one notification requesting that the patient change the state.

44. The ambulatory medical device according to claim 35, wherein the ambulatory medical device includes an audible alert unit coupled with the controller and wherein the therapy manager component is configured to request the patient change the state in response to the detection of the physiological parameter by generating audible alerts to the patient via the audible alert unit.

45. The ambulatory medical device according to claim 44, wherein the therapy manager component is further configured to generate, via the audible alert unit, audible alerts to the patient indicating a delay in the administration of therapy to the patient.

50. The ambulatory medical device according to claim 35, wherein the ambulatory medical device includes a tactile stimulator coupled with the controller, and wherein the therapy manager component is configured to request the patient change the state in response to the detection of the physiological parameter by vibrating the ambulatory medical device controller via the tactile stimulator.

51. The ambulatory medical device according to claim 35, wherein the therapy manager component is configured to delay the administration of therapy to the patient in response to the detection of the change in the state within the predetermined period by delaying the administration for a time interval selected based on a severity of the health disorder.

52. The ambulatory medical device according to claim 35, wherein the therapy manager component is configured to request that the patient change the state of at least two of the two or more response mechanisms in response to the detection of the physiological parameter and the identification of a second mode of the plurality of operation modes as the active operation mode.

53. The ambulatory medical device according to claim 35, wherein the therapy manager component is further configured to administer therapy to the patient in response to detection of no change in the state of the two or more response mechanisms.

73. The ambulatory medical device according to claim 35, wherein the two or more response mechanisms are integrated with the controller.

74. The ambulatory medical device according to claim 35, wherein the two or more response mechanisms are remotely coupled to the controller.

75. The ambulatory medical device according to claim 35, wherein the two or more response mechanisms are electrically coupled to the controller.

76. The ambulatory medical device according to claim 35, wherein one response mechanism of the two or more response mechanisms includes a microphone, integrated with the controller, and wherein the therapy manager component is configured to delay the administration of therapy to the patient in response to detection of a predetermined voice command within the at least one predetermined time period.

38-41. -41. (canceled)

43. (canceled)

46-49. -49. (canceled)

54-71. -71. (canceled)

88. 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; 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.

89. The ambulatory medical device of claim 88, wherein the therapy manager component is further configured to:

monitor the state for a second predetermined period;

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

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

90. The ambulatory medical device of claim 88, wherein the at least one response mechanism is integrated with the controller.

91. The ambulatory medical device of claim 88, wherein the ambulatory medical device includes a display, integrated with the controller and the one response button includes a button displayed on the display.

92. The ambulatory medical device of claim 88, 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.

93. The ambulatory medical device of claim 88, wherein the at least one response mechanism is coupled with the controller.

94. The ambulatory medical device of claim 88, wherein the therapy manager component is configured to notify the patient via at least one of audible, visual, and tactile output.

95. The ambulatory medical device of claim 88, wherein the therapy manager component is configured to notify the patient via at least two of audible, visual, and tactile output.