Wearable cardiac defibrillator system long-term monitoring alternating patient parameters other than ECG

• US 10,016,613 B2
• Filed: 06/30/2015
• Issued: 07/10/2018
• Est. Priority Date: 04/02/2013
• Status: Active Grant

• Current Assignee: West Affum Holdings DAC
• Original Assignee: West Affum Holdings Corp
• Inventors: Kavounas, Gregory T.
• Primary Examiner(s): Carey, Michael
• Application Number:
  US14/788,614
• Publication Number:
  US 20150297904A1
• Time in Patent Office: 1,106 Days
• Field of Search: 607 7
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 7/00 Instruments for auscultation
• CPC Class Codes: A61N 1/046 Specially adapted for shock therapy, e.g. defibrillation
• CPC Class Codes: A61N 1/3904 External heart defibrillators [EHD]
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3968 Constructional arrangements, e.g. casings A61N1/375 takes precedence
• CPC Class Codes: A61N 1/3993 User interfaces for automatic external defibrillators

Abstract

A Wearable Cardiac Defibrillator system includes a support structure with one or more electrodes in an unbiased state. Different sensor modules may monitor, for the long-term, different patient parameters such as the patient'"'"'s motion, a physiological parameter, etc., other than the patient'"'"'s ECG. The sensor modules can be worn by the patient concurrently, or only one at a time as convenient, and may provide respective sensor signals. The system may determine from one or more of the available received signals whether a certain threshold has been reached, such as when the patient is having an actionable episode. If so, at least one electrode may become mechanically biased against the patient'"'"'s body, for making good electrical contact. Then, an ECG reading may be taken and/or electrical therapy may be administered. Since good electrical contact with the skin is not required, the patient'"'"'s discomfort may be reduced and compliance may be increased.

Claims

1. A Wearable Cardiac Defibrillator (WCD) system configured to be worn by a patient who may be moving, the WCD system further configured for use with a first sensor module configured to monitor a first parameter of the patient other than the patient'"'"'s ECG and to make available a first signal generated from the first parameter, the WCD system further configured for use with a second sensor module configured to monitor a second parameter of the patient other than the first parameter and other than the patient'"'"'s ECG and to make available a second signal generated from the second parameter, the WCD system comprising:

a support structure configured to be worn by the patient;

a defibrillator housing, the first sensor module and the second sensor module capable of being outside the defibrillator housing;

an energy storage module configured to store an electrical charge within the defibrillator housing;

a discharge circuit configured to discharge the stored electrical charge through the patient while the support structure is worn by the patient;

a sensor interface configured to receive the first signal and the second signal;

a processor configured to determine from the first signal or from the second signal whether or not a certain severity threshold has been reached;

first electrodes coupled to the support structure, the coupling such that, while the support structure is worn by the patient, at least a certain one of the first electrodes is at one of an unbiased state in which it is moveable with respect to the patient'"'"'s body responsive to the patient'"'"'s moving, and a biased state in which the certain electrode is biased by a biasing force towards the patient'"'"'s body against the support structure so as to be less moveable with respect to the patient'"'"'s body than when in the unbiased state; and

a first biasing mechanism configured to exert the biasing force so as to cause the certain electrode to transition from the unbiased state to the biased state responsive to the determination that the certain severity threshold has been reached.

2. The WCD system of claim 1, in which

the first electrodes are defibrillation electrodes, and

while the certain electrode is in the biased state, the stored electrical charge is configured to be discharged through the patient'"'"'s body via the defibrillation electrodes.

3. The WCD system of claim 1, in which

the first electrodes are ECG electrodes, and

while the certain electrode is in the biased state, an ECG reading of the patient is received via at least the certain electrode.

4. The WCD system of claim 3, further comprising:

defibrillation electrodes, and in which

the stored electrical charge is configured to be discharged through the patient'"'"'s body via the defibrillation electrodes.

5. The WCD system of claim 1, further comprising:

the first sensor module.

6. The WCD system of claim 5, further comprising:

the second sensor module.

7. The WCD system of claim 1, in which

the first sensor module includes a motion detector, and

the first parameter is a motion of the patient'"'"'s body.

8. The WCD system of claim 1, in which

the first sensor module includes a microphone.

9. The WCD system of claim 1, in which

the first sensor module includes a light source.

10. The WCD system of claim 1, in which

the first parameter is heart sounds of the patient, or a heart rate of the patient, or a breathing sound of the patient, or a pulsatile blood flow of the patient, or a blood perfusion of the patient, or a blood pressure of the patient, or a blood oxygen level of the patient, or a change in a light transmission property or a reflection property of perfused tissue of the patient.

11. The WCD system of claim 1, in which

the first sensor module includes a cuff.

12. The WCD system of claim 1, in which

the first sensor module includes a light source and is configured to detect a color of a skin of the patient.

13. The WCD system of claim 1, in which

the first sensor module includes an elastic band configured to be placed so as to be part of a loop around a chest of the patient.

14. The WCD system of claim 13, in which

the first sensor module further includes

a housing configured to be pressed on the chest of the patient by the elastic band, an end of the elastic band section reaching within the housing, and

a spring within the housing that is coupled to the end of the elastic band section.

15. The WCD system of claim 1, in which

the first sensor module includes a communication device configured to communicate the first signal.

16. The WCD system of claim 15, in which

the communication device is configured to communicate the first signal substantially periodically.

17. The WCD system of claim 15, in which

the communication device is configured to receive a polling signal, and to communicate the first signal responsive to receiving the polling signal.

18. The WCD system of claim 15, in further comprising:

an active visual indicator configured to indicate that the first signal is being communicated.

19. The WCD system of claim 1, in which

the first sensor module further includes an active visual indicator configured to indicate that the first signal is being made available.

20. The WCD system of claim 1, in which

the first sensor module includes:

a housing configured to be coupled to the patient'"'"'s body;

a sensor coupled to the housing and configured to monitor the first parameter while the housing is coupled to the patient'"'"'s body; and

a switch configured to place the first sensor module in one of an ON state and an OFF state,

in which the first sensor module is configured to not make available the first signal if the first sensor module is in the OFF state.

21. The WCD system of claim 20, in which

the first sensor module further includes an active visual indicator configured to indicate that the first signal is being made available.

22. The WCD system of claim 1, in which

the first sensor module includes:

a housing configured to be coupled to the patient'"'"'s body;

a sensor coupled to the housing and configured to monitor the first parameter while the housing is coupled to the patient'"'"'s body;

a communication device configured to communicate the first signal; and

a switch configured to place the first sensor module in one of an ON state and an OFF state,

in which the first signal is not communicated if the first sensor module is in the OFF state.

23. The WCD system of claim 22, in which

the first sensor module further includes an active visual indicator configured to indicate that the first signal is being communicated.

24. The WCD system of claim 1, in which

the first sensor module includes:

a housing configured to be coupled to the patient'"'"'s body;

a sensor coupled to the housing and configured to monitor the first parameter while the housing is coupled to the patient'"'"'s body; and

a status sensor configured to determine whether or not the monitored first parameter meets a validity criterion, and

in which the first sensor module is configured to not make available the first signal if it is determined that the first parameter does not meet the validity criterion.

25. The WCD system of claim 24, in which

the status sensor includes at least one of a temperature sensor, a time-keeping mechanism, a motion sensor, a light sensor, and a capacitance sensor.

26. The WCD system of claim 24, in which

the status sensor includes at least two of a temperature sensor, a time-keeping mechanism, a motion sensor, a light sensor, and a capacitance sensor.

27. The WCD system of claim 24, in which

the first sensor module further includes an active visual indicator configured to indicate that the first signal is being made available.

28. The WCD system of claim 1, in which

the first sensor module includes:

a housing configured to be coupled to the patient'"'"'s body;

a sensor coupled to the housing and configured to monitor the first parameter while the housing is coupled to the patient'"'"'s body;

a status sensor configured to determine whether or not the monitored first parameter meets a validity criterion; and

a communication device configured to communicate the first signal, and

in which the first signal is not communicated if it is determined that the first parameter does not meet the validity criterion.

29. The WCD system of claim 28, in which

the status sensor includes at least one of a temperature sensor, a time-keeping mechanism, a motion sensor, a light sensor, and a capacitance sensor.

30. The WCD system of claim 28, in which

the status sensor includes at least two of a temperature sensor, a time-keeping mechanism, a motion sensor, a light sensor, and a capacitance sensor.

31. The WCD system of claim 28, in which

the first sensor module further includes an active visual indicator configured to indicate that the first signal is being communicated.

32. The WCD system of claim 1, in which

the first sensor module is configured to be used with a charging station, and includes:

a housing configured to be coupled to the patient'"'"'s body or alternatively to be placed on the charging station;

a sensor coupled to the housing and configured to monitor the first parameter while the housing is coupled to the patient'"'"'s body; and

a rechargeable battery within the housing and configured to be charged while the housing is placed in the charging station.

33. The WCD system of claim 32, in which

the first sensor module is configured to not make available the first signal while the housing is placed in the charging station.

34. The WCD system of claim 33, in which

the first sensor module further includes an active visual indicator configured to indicate that the first signal is being made available.

35. The WCD system of claim 32, in which

the first sensor module further includes a communication device configured to communicate the first signal, and

in which the first signal is not communicated while the housing is placed in the charging station.

36. The WCD system of claim 1, in which

the first signal encodes a value of the first parameter.

37. The WCD system of claim 1, in which

the first signal encodes an alarm generated from a value of the first parameter.

38. The WCD system of claim 1, in which

the sensor interface is coupled to the defibrillator housing.

39. The WCD system of claim 1, in which

the first signal is received by the sensor interface wirelessly.

40. The WCD system of claim 1, in which

the first signal is received by the sensor interface via one or more wires.

41. The WCD system of claim 1, further comprising:

a first visual indicator configured to indicate that the first signal is being received.

42. The WCD system of claim 41, further comprising:

a second visual indicator configured to indicate that the second signal is being received.

43. The WCD system of claim 1, in which

the first signal is received substantially periodically.

44. The WCD system of claim 1, in which

the sensor interface is configured to transmit a polling signal, and

the first signal is received responsive to the first sensor module receiving the polling signal.

45. The WCD system of claim 44, in which

the polling signal is transmitted substantially periodically.

46. The WCD system of claim 44, in which

the polling signal is transmitted if the first signal meets an alert condition, but not if otherwise.

47. The WCD system of claim 44, in which

the polling signal is transmitted if the second signal meets an alert condition, but not if otherwise.

48. The WCD system of claim 44, in which

the certain severity threshold is reached if the first signal has not been received for a first deadline duration time after the polling signal has been transmitted.

49. The WCD system of claim 1, further comprising:

a user interface configured to issue a query to the patient, and

in which the certain electrode transitions to the biased state only if a preset acceptable input has not been received in response to the query within a preset time after the query has been issued.

50. The WCD system of claim 1, in which

the certain severity threshold is determined to have been reached if the first signal has not been received for a first deadline duration time.

51. The WCD system of claim 1, in which

if only one of the first signal and the second signal is received, the processor is configured to determine whether or not the certain severity threshold has been reached from the received one of the first signal and the second signal.

52. The WCD system of claim 1, in which

even if both the first signal and the second signal are received, the processor is configured to determine whether or not the certain severity threshold has been reached from only one of the first signal and the second signal.

53. The WCD system of claim 1, in which

the processor is configured to determine whether or not the certain severity threshold has been reached from both the first signal and from the second signal.

54. The WCD system of claim 1, in which

the WCD system is further configured for use with a third sensor module, the third sensor module configured to monitor a third parameter of the patient other than the first and the second parameters and other than the patient'"'"'s ECG, the third sensor module configured to make available a third signal generated from the third parameter,

the sensor interface is configured to further receive the third signal, and

the processor is configured to determine whether or not the certain severity threshold has been reached from the first signal or from the second signal or from the third signal.

55. The WCD system of claim 54, in which

if only one of the first signal, the second signal and the third signal is received, the processor is configured to determine whether or not the certain severity threshold has been reached from the received one of the first signal, the second signal, and the third signal.

56. The WCD system of claim 54, in which

even if all three of the first signal, the second signal and the third signal are received, the processor is configured to determine whether or not the certain severity threshold has been reached from only one of the first signal, the second signal and the third signal.

57. The WCD system of claim 54, in which

the processor is configured to determine whether or not the certain severity threshold has been reached from the first signal and from the second signal and from the third signal.