Alarm testing and backup for implanted medical devices with vibration alerts

• US 8,301,231 B2
• Filed: 08/27/2009
• Issued: 10/30/2012
• Est. Priority Date: 08/27/2009
• Status: Active Grant

• Current Assignee: Angel Medical Systems, Inc.
• Original Assignee: Angel Medical Incorporated
• Inventors: Fischell, David R., Harwood, Jonathan, John, Michael Sasha
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US12/461,877
• Publication Number:
  US 20110054334A1
• Time in Patent Office: 1,160 Days
• Field of Search: 600509-528, 607/2, 607115-116
• US Class Current: 600/509
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/33 specially adapted for cooperation with other devices
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Alarm tests are disclosed which use alarm test signals to assess alarms provided by medical devices. Especially relevant are implanted devices that monitor cardiac activity and provide notification in response to medically relevant events. Alarm tests can occur periodically, or in response to a patient, doctor, or remote party initiating the alarm test. Alarm tests can also occur during the actual alarms issued to detected medical events. Alarm tests lead to pass or fail results, which in turn may cause operations to contingently occur. Alarm test failure in the auditory, visual, or tactile modality, may cause an alternatively defined alarm signal to be used as back-up. Alarm test logs can store alarm test results, including quantification of the measured alarm signal. Rapid alarm tests are described, as are various methods of accurately measuring characteristics of the test signal in ambulatory patients, which are especially relevant to a vibration alarm.

Claims

1. A cardiac monitoring system for a human patient including:

an implanted medical device including;

a primary patient alerting means having a vibrator which includes a drive circuit and motor;

an accelerometer, the accelerometer configured to sense movement of the implanted medical device in at least one direction;

at least one sensor for sensing signals from the heart;

a wireless communications system;

a processor, the processor configured to detect abnormalities in the signals from the heart, for actuating the vibrator following detection of abnormalities in the signals from the heart, and to perform an alarm test;

the alarm test including both actuation of the vibrator drive motor for at least one defined test interval and measurement by the processor of alarm-test data sensed by the accelerometer during the test interval, the alarm test further including operating the processor to detect sufficient or insufficient movement of the vibrator during the test interval; and

an external equipment having wireless communication designed to receive signals from the implanted medical device;

wherein when (a) sufficient movement is detected the patient is alerted by the primary patient alerting means and (b) when insufficient movement is detected an insufficient movement signal is generated for actuating a secondary patient alerting means.

2. The system of claim 1 wherein the detection of insufficient movement includes the secondary patient alerting means being designed to notify the patient when insufficient movement is detected.

3. The system of claim 1 wherein the external equipment is designed to alert the patient following the reception of a wireless communication indicating insufficient movement has been detected.

4. The system of claim 1 wherein the external equipment is designed to alert a remote party following the wireless communication indicating insufficient movement has been detected.

5. The system of claim 1 wherein the operation which occurs upon detection of insufficient movement includes wireless communication which notifies a remote party.

6. The system of claim 1, wherein the processor is further configured for transmission to the external equipment of alarm-test data.

7. The system of claim 1 wherein the operation which occurs upon detection of insufficient movement includes adjusting storage of data, including alarm-test data, in the device.

8. The system of claim 1 wherein the processor is further configured to perform an alarm test contingently upon the detection of abnormalities in the signals from the heart whereby the device can assess if an alert signal has successfully been transduced.

9. The system of claim 1 wherein the operation which occurs upon detection of insufficient movement includes implementing a sonic alarm on the implanted device, whereby the sonic alarm serves as a backup alarm that ensures the patient will still be alerted.

10. The system of claim 1 wherein the insufficiency is detected using an alarm test criterion derived using a calibration session, the criterion being stored in the memory of the device.

11. The system of claim 1, wherein the alarm test for detecting insufficiency uses at least one criterion that is set as a function of which of two or more alarm types is being tested, the alarm types including at least a SEE DOCTOR alarm and an EMERGENCY alarm, wherein the alarms have different vibration characteristics.

12. The system of claim 1, wherein at least one criterion is set as a function of which of two or more alarm levels are selected, the alarm levels including at least a low level alarm and a high level alarm.

13. The system of claim 1 wherein the operation which occurs upon detection of insufficient movement includes adjusting a drive voltage pattern that is received by the drive circuit, such adjusting occurring for at least one of the following parameters:

pulse-width modulation, pulse width, inter-pulse duration, duty-cycle of the “

on”

period within each pulse, pulse shape, and pulse frequency.

14. The system of claim 1 wherein the alarm test includes using a vibration alarm test signal with a duration of less than 20 ms.

15. The system of claim 1 wherein the alarm test includes using a vibration alarm test signal that is selected to occur when the patient is sleeping.

16. The system of claim 1 wherein the alarm test includes using a vibration alarm test signal that is selected to occur periodically at a selected time when the patient is normally awake.

17. The system of claim 1 wherein the alarm test detects movement insufficiency using an inter-axis criterion that compares alarm test data sensed from a first axis to data sensed from a second axis, and wherein the second axis is relatively orthogonal to the movement of the motor.

18. The system of claim 1 wherein the alarm test uses an intra-axis criterion that compares at least a portion of alarm test data sensed from a first axis oriented along said one direction to data sensed from the first axis during a period defined to serve as a baseline reference.

19. The system of claim 1 wherein the alarm test evaluates alarm test data using least one of the following measures:

vibration strength, vibration frequency, vibration rise, and vibration decay.

20. The system of claim 1 wherein the alarm test uses criteria designed to detect an increased risk of impending future vibration failure by measuring insufficiency in one of the following measures:

vibration frequency and vibration decay.

21. A cardiac monitoring system for a human patient including:

an implanted medical device including;

a primary patient alerting means having a vibrator which includes a drive circuit and motor;

a microphone which senses acoustic pressure measurements;

at least one sensor for sensing signals from the heart;

a wireless communications system;

a processor, the processor configured to detect abnormalities in the signals from the heart, for actuating the vibrator following detection of abnormalities in the signals from the heart, and to perform an alarm test;

the alarm test including both actuation of the vibrator drive motor for at least one defined test interval and measurement by the processor of alarm-test data sensed by the microphone during the test interval, the alarm test further including operating the processor to detect sufficient or insufficient movement of the vibrator during the test interval; and

an external equipment having wireless communication designed to receive signals from the implanted medical device;

wherein when (a) sufficient movement is detected the patient is alerted by the primary patient alerting means and (b) when insufficient movement is detected an insufficient movement signal is generated for actuating a secondary patient alerting means.