WEARABLE MEDICAL TREATMENT DEVICE WITH MOTION/POSITION DETECTION

• US 20100312297A1
• Filed: 07/21/2010
• Published: 12/09/2010
• Est. Priority Date: 06/13/2007
• 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, Braden, Wade, Volpe, Shane S., Macho, John D.
• Granted Patent: US 8,676,313 B2
• Time in Patent Office: Days
• US Class Current: 607/6
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• 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 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1117 Fall detection
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/1123 Discriminating type of movement, e.g. walking or running A61B5/1116, A61B5/112 take precedence
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/332 Portable devices specially adapted therefor
• CPC Class Codes: A61B 5/339 Displays specially adapted therefor
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6805 Vests
• CPC Class Codes: A61B 5/721 using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61N 1/046 Specially adapted for shock therapy, e.g. defibrillation
• CPC Class Codes: A61N 1/39 Heart defibrillators
• CPC Class Codes: A61N 1/3904 External heart defibrillators [EHD]
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

A wearable defibrillator consists of a vest (or belt) which is worn by the patient. The device monitors the patient'"'"'s ECG with sensing electrodes and can monitor other patient conditions and in appropriate cases can treat certain conditions. An accelerometer(s) in the wearable defibrillator can allow for the device to determine the position, movements, forces applied to the patient, and/or the device. The device can use a least one patient motion detector generating a signal indicative of patient activity. Analysis of the signal can be indicative of patient activity appropriate for treatment or indication of device condition.

Claims

1-22. -22. (canceled)

23. An externally wearable patient treatment device comprising:

cardiac sensing electrodes connected to the device, said cardiac sending electrodes adjacent said patient in proximity to said patient'"'"'s skin;

treatment elements connected to the device, said treatment elements adjacent said patient in proximity to said patient'"'"'s skin;

at least two patient motion detectors connected to the device, each generating a signal indicative of patient activity, wherein placement of the at least two patient motion detectors relative to one another ensures that the device is being worn properly; and

at least one control including a treatment algorithm receiving and evaluating signals from said at least two patient motion detectors and said cardiac sensing electrodes to determine if a treatment should be applied to the patient.

24. The treatment device of claim 23, wherein one of said at least two patient motion detectors is mounted on a patient vest portion, and another of said at least two patient motion detectors is mounted on a display portion.

25. The treatment device of claim 23, further comprising a display portion having a visual display, wherein orientation of the visual display is controlled by the output of said at least two patient motion detectors.

26. The treatment device of claim 23, wherein a body orientation of the patent is determined by the output of the at least two patient motion detectors.

27. The treatment device of claim 26, wherein said body orientation includes a vertical standing orientation and a prone reclining orientation.

28. The treatment device of claim 23, further comprising:

a patient response sensor which can delay treatment when operated by said patient; and

a stimulator alarm providing patient stimulus after a cardiac condition is sensed and before a treatment is initiated,

wherein said treatment algorithm initiates treatment when the output of said at least two patient motion detectors indicates a lack of patient activity and no input is received from said patient response sensor.

29. The treatment device of claim 23, further comprising storage of the output of said at least two patient motion detectors;

and detecting a patient condition based upon the level of activity of a patient over a period of time based upon said stored output of said at least two patient motion detectors.

30. The treatment device of claim 29, further comprising said condition including congestive heart failure.

31. The treatment device of claim 29, further comprising said condition including sleep disorder.

32. The treatment device of claim 29, further comprising providing a treatment directed toward the detected patient condition.

33. The treatment device of claim 23, further comprising a tactile stimulator connected to the device, wherein activation of the tactile stimulator is sensed by the at least two patient motion detectors for self diagnostics.

34. The treatment device of claim 23, further comprising an audio alarm to alert bystanders based upon post treatment detected patient activity.

35. The treatment device of claim 23, wherein an equipment service recommendation is provided to the patient based upon detected mechanical shock above a predetermined threshold level or a number of detected mechanical shocks above a predetermined number.

36. The treatment device of claim 23, wherein if the at least two patient motion detectors detect a mechanical shock over a predetermined threshold, a patient is notified of an abuse event.

37. The treatment device of claim 23, wherein if the at least two patient motion detectors detect a mechanical shock over a predetermined threshold, a date and time of a detected abuse event is recorded.

38. The treatment device of claim 23, wherein if the at least two patient motion detectors detect a mechanical shock over a predetermined threshold, the treatment device initiates internal self-diagnostics.

39. The treatment device of claim 23, wherein a fall-off event of a treatment element detaching from the device is sensed, and the patient body state during the fall-off event, as sensed by the at least two patient motion detectors, is recorded.

40. The treatment device of claim 39, wherein the recorded patient body state during the fall-off event is analyzed to improve device design.

41. The treatment device of claim 23, wherein patient activity information during a sensed cardiac condition is detected by the at least two patient motion detectors, and the patient is notified of a false detection based up the detected patient activity.

42. The treatment device of claim 23, wherein the output of said at least two patient motion detectors is evaluated to determine a patient activity and a patient body orientation, and wherein an audio volume of an audio message to the patient is increased upon detection of an unchanged body state for a period of time.

43. The treatment device of claim 23, wherein if the at least two patient motion detectors detect a mechanical shock over a predetermined threshold, a request for service is automatically downloaded to a manufacturer of the treatment device.

44. The treatment device of claim 23, wherein at least one of the at least two patient motion detectors comprises an accelerometer.

45. An externally wearable patient treatment device comprising:

cardiac sensing electrodes connected to the device, said cardiac sensing electrodes adjacent said patient in proximity to said patient'"'"'s skin;

treatment elements connected to the device, said treatment elements adjacent said patient in proximity to said patient'"'"'s skin;

at least one patient motion detector connected to the device and generating a signal indicative of patient activity; and

at least one control to evaluate signals from said at least one patient motion detector and said cardiac sensing electrodes to determine if said signals are indicative of patient activity appropriate for treatment.

46. The treatment device of claim 45, wherein said at least one patient motion detector includes at least one accelerometer.

47. The treatment device of claim 45, wherein said at least one patient motion detector includes at least one multi-axis accelerometer.

48. The treatment device of claim 45, wherein said at least one patient motion detector includes at least two three-axis accelerometers, with one of said accelerometers mounted on a patient vest portion, and another of said accelerometers mounted on a display portion.

49. The treatment device of claim 45, further including a visual display on said display portion, wherein the orientation of said visual display is controlled by the output of said at least one patient motion detector.

50. The treatment device of claim 45, wherein a body orientation of the patient is determined by the output of said at least one patient motion detector.

51. The treatment device of claim 50, wherein said body orientation includes a vertical standing orientation and a prone reclining orientation.

52. The treatment device of claim 45, further comprising storage of the output of said at least one patient motion detector;

and detecting a patient condition based upon the level of activity of a patient over a period of time based upon said stored output of said at least one patient motion detector.

53. The treatment device of claim 52, further comprising said condition including congestive heart failure.

54. The treatment device of claim 52, further comprising said condition including sleep disorder.

55. The treatment device of claim 52, further comprising providing a treatment directed toward the detected patient condition.

56. The treatment device of claim 45, further comprising storage of the output of said at least one patient motion detector;

and indicating a patient condition based upon sensed activity level and body position of said patient.

57. The treatment device of claim 45, wherein the at least one patient motion detector includes at least two accelerometers.

58. The treatment device of claim 57, where a determination is made on whether the device is being worn properly by a patient based upon detection of placement of the at least two accelerometers relative to one another.

59. The treatment device of claim 45, further comprising a tactile stimulator connected to the device, wherein activation of the tactile stimulator is sensed by the at least one patient motion detector for self diagnostics.

60. The treatment device of claim 45, further comprising an audio alarm to alert bystanders based upon post treatment detected patient activity.

61. The treatment device of claim 45, wherein an equipment service recommendation is provided to the patient based upon detected mechanical shock above a predetermined threshold level or a number of detected mechanical shocks above a predetermined number.

62. The treatment device of claim 45, further comprising a treatment algorithm receiving inputs from the at least one patient motion detector and/or and the cardiac sensing electrodes, said treatment algorithm analyzing said inputs to determine if the patient requires treatment.

63. The treatment device of claim 45, wherein if the at least one patient motion detector detects a mechanical shock over a predetermined threshold, a patient is notified of an abuse event.

64. The treatment device of claim 45, wherein if the at least one patient motion detector detects a mechanical shock over a predetermined threshold, a date and time of a detected abuse event is recorded.

65. The treatment device of claim 45, wherein if the at least one patient motion detector detects a mechanical shock over a predetermined threshold, the treatment device initiates internal self-diagnostics.

66. The treatment device of claim 45, wherein a fall-off event of a treatment element detaching from the device is sensed, and the patient body state during the fall-off event, as sensed by the at least one patient motion detector, is recorded.

67. The treatment device of claim 66, wherein the recorded patient body state during the fall-off event is analyzed to improve device design.

68. The treatment device of claim 45, wherein patient activity information during a sensed cardiac condition is detected by the at least one patient motion detector, and the patient is notified of a false detection based up the detected patient activity.

69. The treatment device of claim 45, wherein the output of the at least one patient motion detector is evaluated to determine a patient activity and a patient body orientation, and wherein an audio volume of an audio message to the patient is increased upon detection of an unchanged body state for a period of time.

70. The treatment device of claim 45, wherein if the at least one patient motion detector detects a mechanical shock over a predetermined threshold, a request for service is automatically downloaded to a manufacturer of the treatment device.

71. The treatment device of claim 45, further comprising a treatment algorithm receiving inputs from the at least one patient motion detector and/or and the cardiac sensing electrodes, wherein said treatment algorithm accelerates or delays a treatment to the patient based upon the output of said at least one patient motion detector and/or the cardiac sensing electrodes.

72. The treatment device of claim 71, further comprising:

a patient response sensor which can delay treatment when operated by a patient; and

a stimulator alarm providing stimulus after a cardiac condition is sensed and before a treatment is initiated,

wherein said treatment algorithm initiates treatment when the output of said at least one patient motion detector indicates a lack of patient activity and no input is received from said patient response sensor.

73. A method of cardiac treatment of a patient including:

providing an externally wearable patient treatment device including treatment elements adjacent said patient in proximity to said patient'"'"'s skin, and at least one patient motion detector connected to the device and generating a signal indicative of patient activity;

sensing a cardiac condition;

treating a cardiac condition with the treatment elements worn by said patient on the device adjacent said patient;

sensing patient activity with the at least one patient motion detector worn by said patient on the device; and

evaluating said sensed patient activity to determine treatment appropriate to said cardiac condition.

74. The method of claim 73, further including:

evaluating the output of said at least on patient motion detector to determine a patient activity and a patient body orientation.

75. The method of claim 73, further including sensing an accelerating motion of said patient.

76. The method of claim 73, further including sensing patient acceleration in multiple axes and at least two positions.

77. The method of claim 76, wherein said two positions includes a vertical position and a prone position.

78. The method of claim 73, further including displaying patient information on a visual display and orienting the visual display dependent upon patient body orientation.

79. The method of claim 73, further comprising determining patient body position from said detected patient activity.

80. The method of claim 73, further comprising accelerating or delaying treatment based upon detected patient activity.

81. The method of claim 73, further comprising providing patient stimulus upon a sensed cardiac condition;

and treating said condition while sensing patient activity if the patient fails to respond timely to said patient stimulus.

82. The method of claim 73, further comprising verifying a treatment application based upon detected patient activity.

83. The method of claim 82, wherein the detected patient activity includes muscle spasms.

84. The method of claim 73, further comprising storing information regarding patient activity;

and analyzing the stored information for improved device operation and/or comfort.

85. The method of claim 73, further comprising performing a self diagnosis based upon detection of a known device vibration by the at least one patient motion detector.

86. The method of claim 73, further comprising detecting patient activity information during a sensed cardiac condition;

and notifying the patient of a false detection based up the detected patient activity.

87. The method of claim 86, wherein the detected patient activity comprises vibration and/or acceleration.

88. The method of claim 73, further comprising sensing a fall-off event of a treatment element detaching from the device;

and recording the patient body state during the fall-off event.

89. The method of claim 88, further comprising analyzing the recorded patient body states during the fall-off event to improve device design.

90. The method of claim 73, further comprising identifying device abuse;

and

notifying the patient of the abuse event.

91. The method of claim 73, further comprising identifying device abuse;

and

triggering a remedial action upon detection of an abuse event.

92. The method of claim 73, further comprising identifying device abuse;

and

recording a date and time associated with detected abuse events.

93. The method of claim 73, further comprising identifying device abuse, wherein an abuse event comprises detection of a mechanical shock over a predetermined threshold.

94. The method of claim 73, wherein the at least one patient motion detector comprises at least two patient motion detectors, the method further comprising confirming the device is being worn correctly by the patient based upon placement of the at least two motion detectors relative to one another.

95. The method of claim 73, further comprising increasing an audio volume of an audio message to the patient upon detection of an unchanged body state for a period of time.

96. The method of claim 73, further comprising recording patent treatment events and patient activity;

and analyzing the recorded treatment and patient activity data to determine patient specific conditions.

97. The method of claim 96, further comprising said condition including congestive heart failure.

98. The method of claim 96, further comprising said condition including sleep disorder.

99. The method of claim 96, further comprising providing a treatment directed toward a determined patient specific condition.

100. The method of claim 73, further comprising recording patient treatment events and patient activity;

and comparing the recorded treatment and patient activity data for the patient with treatment and patient activity data for other patients.

101. The method of claim 73, further comprising:

providing a patient response sensor which can delay treatment when operated by said patient; and

providing a stimulator alarm providing patient stimulus after a cardiac condition is sensed and before a treatment is initiated,

wherein said treatment is initiated when the output of the at least one patient motion detector indicates a lack of patient activity and no input is received from said patient response sensor.

102. The method of claim 73, further comprising automatically downloading a request for service to a manufacturer of the treatment device if a mechanical shock over a predetermined threshold is detected.

103. The method of claim 73, further comprising:

sensing post treatment patient activity with the at least one patient motion detector worn by said patient on the device; and

providing an alarm to alert bystanders based upon post treatment patient activity before another treatment is initiated.