Wearable medical treatment device with motion/position detection

• US 10,582,858 B2
• Filed: 12/21/2017
• Issued: 03/10/2020
• 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 W.
• Primary Examiner(s): Voorhees, Catherine M
• Application Number:
  US15/850,435
• Publication Number:
  US 20180110419A1
• Time in Patent Office: 810 Days
• 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 cardiac monitoring system includes cardiac sensing electrodes for external placement proximate to the patient to sense ECG signals of the patient; one or more accelerometers configured to generate patient activity data based on signals corresponding to changes in the patient'"'"'s body position and movement; and a monitoring computer configured to correlate the ECG signals of the patient with the patient activity data generated from the one or more accelerometers to determine ECG signal contamination, analyze the ECG signals of the patient to extract at least heart rate data of the patient and detect a cardiac arrhythmia based at least in part on the heart rate data, and change a confidence in the detected cardiac arrhythmia based on the determined ECG signal contamination; wherein at least the patient activity data and the heart rate data are analyzed to determine a change in a physiological condition of the patient over time.

Claims

1. A cardiac monitoring system comprising:

cardiac sensing electrodes configured for external placement proximate to a patient and to sense ECG signals of the patient;

one or more accelerometers configured to generate patient activity data based on signals corresponding to changes in the patient'"'"'s body position and movement; and

a monitoring computer disposed in the cardiac monitoring system and operationally coupled to the cardiac sensing electrodes and the one or more accelerometers, the monitoring computer configured to

correlate the ECG signals of the patient with the patient activity data generated from the one or more accelerometers to determine ECG signal contamination,

analyze the ECG signals of the patient to extract at least heart rate data of the patient and detect a cardiac arrhythmia based at least in part on the heart rate data,

change a confidence in the detected cardiac arrhythmia based on the determined ECG signal contamination by evaluating the patient activity data for a change in body state during the detection of the cardiac arrhythmia, wherein changing a confidence in the detected cardiac arrhythmia comprises

determining that the patient is unconscious if there has been no change in patient body state during the detection of the cardiac arrhythmia,

determining that the patient is conscious if there has been a change in patient body state during the detection of the cardiac arrhythmia,

increasing the confidence in the detected cardiac arrhythmia based on determining that the patient is unconscious, and

decreasing the confidence in the detected cardiac arrhythmia based on determining that the patient is conscious,

wherein at least the patient activity data and the heart rate data are analyzed to determine a change in a physiological condition of the patient over a period of time.

2. The cardiac monitoring system of claim 1, wherein the patient activity data is measured and stored in the monitoring computer over time and provided as feedback to a doctor about the physiological condition of the patient.

3. The cardiac monitoring system of claim 1, wherein the patient activity data is communicated to at least one of a doctor and a data evaluation system to analyze the patient activity data.

4. The cardiac monitoring system of claim 3, wherein the patient activity data is analyzed to determine patient deterioration in a congestive heart failure patient based at least on the patient'"'"'s body position at rest.

5. The cardiac monitoring system of claim 3, wherein the patient activity data is analyzed to determine whether the patient activity data is indicative of a reduction in patient activity over the period of time.

6. The cardiac monitoring system of claim 3, wherein the patient activity data is analyzed to determine whether the patient activity data is indicative of worsening congestive heart failure.

7. The cardiac monitoring system of claim 1, wherein the one or more accelerometers includes at least two three-axis accelerometers.

8. The cardiac monitoring system of claim 7, wherein one of the at least two three-axis accelerometers is mounted on a patient vest portion of the cardiac monitoring system.

9. The cardiac monitoring system of claim 3, further comprising

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

and

wherein the monitoring computer is operationally coupled to the treatment elements, the monitoring computer configured to

detect the cardiac arrhythmia of the patient based on at least one of the patient activity data and the ECG signals of the patient, and

provide a treatment directed to the cardiac arrhythmia via the treatment elements.

10. A wearable defibrillation device comprising:

cardiac sensing electrodes configured for external placement proximate to a patient and to sense ECG signals of the patient;

one or more therapy pads disposed on the patient;

one or more accelerometers configured to generate patient activity data based on signals corresponding to changes in the patient'"'"'s body position and movement; and

a monitoring computer disposed in the wearable defibrillation device, the monitoring computer configured to

correlate the ECG signals of the patient with the patient activity data generated from the one or more accelerometers to determine ECG signal contamination,

analyze the ECG signals of the patient to extract at least heart rate data of the patient,

determine from at least the heart rate data and the patient activity data that a treatable arrhythmia condition exists,

increase or decrease a confidence in a determined treatable arrhythmia condition based on the determined ECG signal contamination by evaluating the patient activity data for a change in body state during detection of the treatable arrhythmia condition, wherein increasing or decreasing a confidence in the detected treatable arrhythmia condition comprises

determining that the patient is unconscious if there has been no change in patient body state during the detection of the treatable arrhythmia condition,

decreasing the confidence in the detected treatable arrhythmia condition based on determining that the patient is conscious, and

increasing the confidence in the detected treatable arrhythmia condition based on determining that the patient is unconscious, and

responsive to an increase in the confidence in the determined treatable arrhythmia condition, deliver a therapeutic shock to the patient through the one or more therapy pads;

wherein at least the patient activity data and the heart rate data are further analyzed to determine a change in a physiological condition of the patient over a period of time.

11. The wearable defibrillation device of claim 10, wherein the patient activity data is measured and stored in the monitoring computer over time and provided as feedback to a doctor about the physiological condition of the patient.

12. The wearable defibrillation device of claim 10, wherein the patient activity data is communicated to at least one of a doctor and a data evaluation system to determine whether proper patient activity levels are met.

13. The wearable defibrillation device of claim 12, wherein the patient is a congestive heart failure patient, and wherein the patient activity data is analyzed to determine patient deterioration based at least on the patient'"'"'s body position at rest.

14. The wearable defibrillation device of claim 12, wherein the patient activity data is analyzed to determine whether the patient activity data is indicative of worsening congestive heart failure.

15. The wearable defibrillation device of claim 10, wherein the one or more accelerometers includes at least two three-axis accelerometers.

16. The wearable defibrillation device of claim 15, wherein one of the at least two three-axis accelerometers is mounted on a patient vest portion of the wearable defibrillation device.

17. A method of monitoring a patient, the method comprising:

sensing ECG signals of the patient;

generating patient activity data based on signals from one or more accelerometers, the signals corresponding to changes in the patient'"'"'s body position and movement;

correlating the ECG signals of the patient with the patient activity data to determine ECG signal contamination;

analyzing the ECG signals of the patient to extract at least heart rate data of the patient and detect a cardiac arrhythmia based at least in part on the heart rate data;

changing a confidence in the detected cardiac arrhythmia based on the determined ECG signal contamination by evaluating the patient activity data for a change in body state during the detection of the cardiac arrhythmia, wherein changing a confidence in the detected cardiac arrhythmia comprises

determining that the patient is unconscious if there has been no change in patient body state during the detection of the cardiac arrhythmia, and increasing the confidence in the detected cardiac arrhythmia based on determining that the patient is unconscious, and

determining that the patient is conscious if there has been a change in patient body state during the detection of the cardiac arrhythmia, and decreasing the confidence in the detected cardiac arrhythmia based on determining that the patient is conscious; and

analyzing at least the patient activity data and the heart rate data to determine a change in a physiological condition of the patient over a period of time.

18. The method of monitoring a patient of claim 17, further comprising measuring and storing the patient activity data over the period of time and providing the stored patient activity data to a doctor as feedback about the physiological condition of the patient.

19. The method of monitoring a patient of claim 18, further comprising providing a treatment directed to the physiological condition.