System and method for adapting alarms in a wearable medical device

• US 9,597,523 B2
• Filed: 02/10/2015
• Issued: 03/21/2017
• Est. Priority Date: 02/12/2014
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Inventors: Kaib, Thomas E., Freeman, Gary A., Tan, Qing
• Primary Examiner(s): Johnson, Nicole F
• Application Number:
  US14/618,588
• Publication Number:
  US 20150224330A1
• Time in Patent Office: 770 Days
• Field of Search: 607/7, 607/60
• US Class Current: 1/1
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/3904 External heart defibrillators [EHD]
• CPC Class Codes: A61N 1/3993 User interfaces for automatic external defibrillators
• CPC Class Codes: G08B 21/0453 worn on the body to detect health condition by physiological monitoring, e.g. electrocardiogram, temperature, breathing detecting, measuring or recording for diagnostic purposes A61B5/00

Abstract

In one example, an external medical device is provided. The external medical device includes a memory, at least one sensor to detect a cardiac condition in a patient monitored by the external medical device, and circuitry, in communication with the memory, to receive information indicative of the cardiac condition, detect whether the patient is asleep, and issue at least one alarm responsive to both receiving the information and detecting that the patient is asleep.

Claims

1. An external medical device comprising:

a memory;

at least one electrode to detect a cardiac arrhythmia treatable by a defibrillation shock in a patient monitored by the external medical device;

an interface to issue at least one mild shock to awaken the patient to enable the patient to respond to at least one alarm;

circuitry, in communication with the memory, to;

receive information indicative of the cardiac arrhythmia;

detect whether the patient is asleep;

issue the at least one alarm responsive to both receiving the information and detecting that the patient is asleep, the at least one alarm comprising the at least one mild shock to awaken the patient; and

issue the defibrillating shock in response to not receiving a response to the at least one alarm within a target response time.

2. The external medical device of claim 1, wherein the external medical device comprises a wearable defibrillator.

3. The external medical device of claim 1, wherein the information comprises data descriptive of at least one of patient physiological, time of day, patient motion, patient body position, proximity of the external medical device to other devices, and lack of patient responsiveness.

4. The external medical device of claim 1, wherein the at least one mild shock comprises a current in a range of 1 mA and 20 mA.

5. The external medical device of claim 1, wherein the interface comprises at least one electrode to issue the at least one alarm as the at least one mild shock, the at least one electrode comprising at least one of a sensing electrode, a defibrillation electrode, an alarm electrode, and an electrode of a transcutaneous electrical nerve stimulation unit.

6. The external medical device of claim 1, wherein the interface comprises at least two defibrillation electrodes to issue the at least one mild shock along a current path that traverses a portion of the patient other than a heart of the patient.

7. The external medical device of claim 1, wherein the at least one mild shock has a damped sinusoidal waveform to alert the patient.

8. The external medical device of claim 1, wherein the cardiac arrhythmia comprises bradycardia and the at least one mild shock comprises a plurality of pacing pulses sequenced according to a sub-threshold pacing process.

9. The external medical device of claim 1, wherein the cardiac arrhythmia comprises bradycardia and the at least one mild shock comprises a plurality of pacing pulses comprising progressively increasing current.

10. The external medical device of claim 1, wherein the at least one alarm comprises at least one vibration output followed by the at least one mild shock.

11. The external medical device of claim 1, wherein the at least one alarm comprises at least one audio output followed by the at least one mild shock.

12. The external medical device of claim 1, wherein the at least one alarm comprises at least one vibration output followed by at least one audio output followed by the at least one mild shock.

24. The external medical device of claim 1, wherein the interface comprises one or more electrodes to issue the at least one alarm as the at least one mild shock, the one or more electrodes comprising at least one of a sensing electrode, a defibrillation electrode, an alarm electrode, and an electrode of a transcutaneous electrical nerve stimulation unit.

25. The external medical device of claim 1, wherein at least one configurable parameter specifies at least one of an intensity of the at least one mild shock, a number of electrical pulses comprised within the at least one mild shock, a width of electrical pulses comprised within the at least one mild shock, and an amplitude of electrical pulses comprised within the at least one mild shock.

26. The external medical device of claim 1, wherein the at least one mild shock comprises a series of concatenated pulses.

27. The external medical device of claim 1, wherein the at least one mild shock comprises a plurality of shocks and one mild shock of the plurality of shocks has at least one characteristic that varies from at least one other characteristic of at least one other shock of the plurality of shocks.

28. The external medical device of claim 27, wherein the at least one characteristic comprises at least one of amplitude, width, and shape.

29. The external medical device of claim 27, wherein the at least one other characteristic increases from the at least one characteristic.

30. The external medical device of claim 6, wherein the at least two defibrillation electrodes are positioned near one another to form the current path.

31. The external medical device of claim 8, wherein the at least one mild shock comprises a shock issued via an electrode of a transcutaneous electrical nerve stimulation unit prior to the plurality of pacing pulses.

32. The external medical device of claim 1, wherein the interface comprises a plurality of electrodes disposed close to each other to form a current path that intersects planes other than a plane through a heart of the patient.

33. The external medical device of claim 1, wherein the at least one mild shock comprises at least one pulse having a width between 10 μ

s and 100 ms.

34. The external medical device of claim 1, wherein the at least one mild shock comprises a train of pulses.

35. The external medical device of claim 34, wherein at least two pulses of the train of pulses have different characteristics.

36. The external medical device of claim 34, wherein at least two pulses of the train of pulses are gradually varied to not stress the patient.

37. The external medical device of claim 1, wherein the at least one mild shock has a biphasic waveform.

13. A method of adapting alarms issued by an external medical device comprising circuitry and at least one electrode to detect a cardiac arrhythmia in a patient monitored by the external medical device, the method comprising:

receiving, by the circuitry, information indicative of the cardiac arrhythmia, the cardiac arrhythmia being treatable by a defibrillation shock;

detecting whether the patient is asleep;

issuing at least one alarm responsive to both receiving the information and detecting that the patient is asleep, the at least one alarm comprising at least one mild shock to awaken the patient; and

issuing the defibrillating shock in response to not receiving a response to the at least one alarm within a target response time.

14. The method of claim 13, wherein issuing the at least one alarm comprises issuing the at least one mild shock with a current in a range of 1 mA and 20 mA.

15. The method of claim 13, wherein the external medical device comprises at least one electrode comprising at least one of a sensing electrode, a defibrillation electrode, an alarm electrode, and an electrode of a transcutaneous electrical nerve stimulation unit and issuing the at least one alarm comprises issuing the at least one mild shock via the at least one electrode.

16. The method of claim 13, wherein the external medical device comprises at least two defibrillation electrodes disposed to form a current path that traverses a portion of the patient other than a heart of the patient and issuing the at least one alarm comprises issuing the at least one mild shock along the current path between the at least two defibrillation electrodes.

17. The method of claim 13, wherein issuing the at least one alarm comprises issuing the at least one mild shock with a damped sinusoidal waveform to alert the patient.

18. The method of claim 13, wherein the cardiac arrhythmia comprises bradycardia and issuing the at least one alarm comprises issuing the at least one mild shock as a plurality of pacing pulses sequenced according to a sub-threshold pacing process, the plurality of pacing pulses comprising progressively increasing current.

19. The method of claim 13, wherein issuing the at least one alarm comprises issuing at least one vibration output followed by at the least one mild shock.

20. The method of claim 13, wherein issuing the at least one alarm comprises issuing at least one audio output followed by at the least one mild shock.

21. The method of claim 13, wherein issuing the at least one alarm comprises issuing at least one vibration output followed by at least one audio output followed by the at least one mild shock.

22. A non-transitory computer readable medium storing computer executable sequences of instructions for adapting alarms issued by an external medical device, the sequences of instructions comprising instructions that instruct circuitry comprised within the external medical device to:

receive information indicative of a cardiac arrhythmia in a patent from at least one electrode of the external medical device, the cardiac arrhythmia being treatable by a defibrillation shock;

detect whether a patient monitored by the external medical device is asleep;

issue at least one alarm responsive to both receiving the information and detecting that the patient is asleep, the at least one alarm comprising at least one mild shock to awaken the patient; and

issue the defibrillating shock in response to not receiving a response to the at least one alarm within a target response time.

23. The computer readable medium of claim 22, wherein the instructions instruct the circuitry to issue the at least one alarm by issuing the at least one mild shock with a current in a range of 1 mA and 20 mA.