Wearable medical treatment device with motion/position detection

• US 8,676,313 B2
• Filed: 07/21/2010
• Issued: 03/18/2014
• 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: Volpe, Shane S., Macho, John D., Braden, Wade, Kaib, Thomas E., Linder, Marshal
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): VOORHEES, CATHERINE M
• Application Number:
  US12/840,633
• Publication Number:
  US 20100312297A1
• Time in Patent Office: 1,336 Days
• Field of Search: 607 4- 7, 607/9, 607/27, 607/146, 600/301, 600/481, 600508-509
• 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. An externally wearable patient treatment device comprising:

cardiac sensing electrodes configured for external placement proximate to a patient to sense cardiac information of the patient;

treatment elements configured for external placement proximate to the patient;

at least one motion detector configured to generate a signal indicative of motion of the treatment device; and

at least one controller disposed in the treatment device and coupled to the at least one motion detector, the cardiac sensing electrodes, and the treatment elements and configured to receive the signal indicative of motion of the treatment device and determine whether the treatment device is subjected to a force greater than a predefined acceptable force based on the signal.

2. The treatment device of claim 1, wherein the at least one motion detector includes at least one accelerometer.

3. The treatment device of claim 1, wherein the at least one motion detector includes at least one multi-axis accelerometer.

4. The treatment device of claim 1, wherein the at least one motion detector includes at least two three-axis accelerometers, with one of the at least two three-axis accelerometers mounted on a patient vest portion of the treatment device, and another of the at least two three-axis accelerometers mounted on a display portion of the treatment device.

5. The treatment device of claim 1, further including a visual display portion, wherein an orientation of the visual display is based on the signal.

6. The treatment device of claim 1, wherein the at least one motion detector includes at least two accelerometers.

7. The treatment device of claim 1, further comprising an audio alarm coupled to the at least one controller and configured to provide an alert responsive to determining that the treatment device is subjected to the force greater than the predefined acceptable force.

8. The treatment device of claim 1, wherein the at least one controller is configured to provide an equipment service recommendation responsive to determining that the treatment device is subjected to the force greater than the predefined acceptable force.

9. The treatment device of claim 1, wherein the at least one controller is further configured to notify a patient of an abuse event in response to determining that the treatment device is subjected to the force greater than the predefined acceptable force.

10. The treatment device of claim 1, wherein the at least one controller is further configured to detect a date and time of a detected abuse event responsive to determining that the treatment device is subjected to the force greater than the predefined acceptable force.

11. The treatment device of claim 1, wherein the at least one controller is further configured to initiate internal self-diagnostics responsive to determining that the treatment device is subjected to the force greater than the predefined acceptable force.

12. The treatment device of claim 1, wherein the at least one controller is further configured to provide a request for service to a manufacturer of the treatment device responsive to determining that the treatment device is subjected to the force greater than the predefined acceptable force.

13. The treatment device of claim 4, further including a visual display on the display portion, wherein an orientation of the visual display is based on an output of the other of the at least two three-axis accelerometers mounted on the display portion.

14. The treatment device of claim 1, wherein the at least one controller is further configured to detect a mechanically noisy environment based on the signal.

15. The treatment device of claim 14, wherein the at least one controller is further configured to detect a cardiac arrhythmia of the patient based on the sensed cardiac information of the patient, and to decrease a confidence in the detected cardiac arrhythmia responsive to detecting the mechanically noisy environment.

16. The treatment device of claim 14, wherein the at least one controller is further configured to detect a cardiac arrhythmia of the patient based on the sensed cardiac information of the patient, to determine whether a high degree of correlation exists between the signal and the sensed cardiac information of the patient, and to decrease a confidence in the detected cardiac arrhythmia of the patient responsive to detecting that the high degree of correlation exists between the signal and the sensed cardiac information of the patient.

17. The treatment device of claim 1, wherein the at least one controller is further configured to increase an audio volume output of an audio message to the patient based on a determination that a body state of the patient is unchanged using the signal.

18. The treatment device of claim 1, wherein the at least one controller is further configured to determine a number of times that the treatment device is subjected to a force less than the predefined acceptable force based on the signal, and to provide an equipment service recommendation responsive to determining that the treatment device has been subjected to the force less than the predefined acceptable force at least a predetermined number of times.

19. A method of treatment of a patient including:

providing an externally wearable patient treatment device, the externally wearable patient treatment device including cardiac sensing electrodes configured for external placement proximate to the patient to sense cardiac information of the patient, treatment elements configured to be disposed adjacent the patient in proximity to the patient'"'"'s skin, at least one motion detector configured to detect motion of the treatment device, and at least one processor coupled to the at least one motion detector;

sensing motion of the treatment device with the at least one motion detector; and

evaluating the motion of the treatment device sensed by the at least one motion detector using the at least one processor to determine whether the treatment device is subjected to a force greater than a predefined acceptable force.

20. The method of claim 19, further including sensing an accelerating motion of the treatment device.

21. The method of claim 19, further including sensing acceleration of the treatment device in multiple axes.

22. The method of claim 19, further including displaying patient information on a visual display and orienting the visual display dependent upon the sensed motion of the treatment device.

23. The method of claim 19, further comprising performing a self diagnosis of the treatment device using the at least one processor based upon a determination that the treatment device is subjected to the force greater than the predefined acceptable force.

24. The method of claim 19, further comprising identifying a device abuse event responsive to a determination that the treatment device is subjected to the force greater than the predefined acceptable force and notifying the patient of the device abuse event.

25. The method of claim 19, further comprising identifying a device abuse event responsive to a determination that the treatment device is subjected to the force greater than the predefined acceptable force and triggering a remedial action in response to identifying the device abuse event.

26. The method of claim 19, further comprising identifying a device abuse event responsive to a determination that the treatment device is subjected to a force greater than the predefined acceptable force and recording a date and time of the device abuse event in response to identifying the device abuse event.

27. The method of claim 19, further comprising identifying a device abuse event, wherein the device abuse event comprises detection of a mechanical shock over a predetermined threshold.

28. The method of claim 19, further comprising:

detecting a mechanical shock over a predetermined threshold; and

providing a request for service to a manufacturer of the treatment device responsive to detecting the mechanical shock.

29. The method of claim 19, further comprising recording a date/time stamp responsive to a determination that the treatment device is subjected to the force greater than the predefined acceptable force.

30. The method of claim 29, further comprising correlating the date/time stamp and a location of the treatment device with a carrier tracking number to determine whether the force greater than the predetermined acceptable force occurred during shipping.