Systems and methods of alarm validation and backup in implanted medical devices

• US 8,269,634 B2
• Filed: 08/27/2009
• Issued: 09/18/2012
• Est. Priority Date: 08/27/2009
• Status: Active Grant

• Current Assignee: Angel Medical Systems, Inc.
• Original Assignee: Angel Medical Systems, Inc.
• Inventors: Fischell, David R., John, Michael Sasha
• Primary Examiner(s): Lau, Hoi
• Application Number:
  US12/461,876
• Publication Number:
  US 20110054264A1
• Time in Patent Office: 1,118 Days
• Field of Search: 340/573.1, 340/514, 600/300, 600509-528, 607/30, 607/59, 607115-116, 607/2
• US Class Current: 340/573.1
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 monitoring system for a human patient including:

an implanted medical device including;

a first internal patient alerting sub-system capable of generating at least a first internal alarm signal;

a first sensor configured to sense actuation of the first internal patient alerting sub-system;

a second sensor for sensing data for calculating a medical condition of the human patient;

a wireless communications system;

a processor, the processor configured to detect abnormalities in the patient'"'"'s medical condition, the processor further configured to actuate the first internal patient alerting sub-system following detection of abnormalities in the patient'"'"'s medical condition, the processor also configured to perform an alarm test;

the alarm test including both actuation of the first internal patient alerting sub-system for at least one test interval and measurement by the processor of the first internal alarm signal generated by the first internal patient alerting sub-system during the test interval, the processor further configured to detect at least one of sufficiency and insufficiency in the first internal alarm signal during the test interval;

external equipment including wireless communication designed to receive signals from the implanted medical device; and

,

a secondary patient alerting sub-system capable of generating a second alarm signal, designed to notify the patient when insufficiency is detected in the first internal alarm signal.

2. The system of claim of 1, wherein the first internal alarm signal includes a vibration alarm signal and the alarm test is configured to test a vibration alarm.

3. The system of claim of 1, wherein the first internal alarm signal includes a sonic alarm signal and the alarm test is configured to test a sonic alarm.

4. The system of claim 1, wherein the first sensor is at least one of:

an accelerometer; and

, a microphone.

5. The system of claim 1, wherein a secondary patient alerting sub-system is implanted and the second alarm signal is internal.

6. The system of claim 1, wherein the second alarm signal comprises communication with a remote party and includes at least one of:

communication sent to the remote party from the external equipment; and

, communication sent from the remote party to the patient.

7. The system of claim 1, wherein the implanted device configured for relaying the alarm test results to a remote party using at least one of:

wireless communication; and

, communication using the external equipment.

8. The system of claim 1, wherein the external equipment including wireless communication designed to receive signals from the implanted medical device includes a physician programmer which is configured to receive signals related to the alarm test results.

9. The system of claim 1, wherein the external equipment including wireless communication designed to receive signals from the implanted medical device includes an External Patient Device (EXD) which is configured to receive signals related to the alarm test results.

10. The system of claim 1, wherein the implanted device is further configured with a wireless communications system configured to receive a perform alarm-test command from the external equipment and to operate the device processor to perform an alarm-test of the alarm signal.

11. The device of claim 1 wherein the sensed data is cardiac data and the medical condition is acute ischemia.

12. The device of claim 1 wherein the sensed data is cardiac data and the medical relevant event is arrhythmia.

13. The system of claim 1 wherein the system is further configured with a stimulation sub-system configured to provide electrical therapy of the patient'"'"'s heart.

14. The system of claim 1 wherein the alarm test is configured to test at least one of:

a SEE DOCTOR alarm; and

, an EMERGENCY alarm, and wherein each alarm has different characteristics.

15. The system of claim 1 wherein the alarm test is performed concurrently with an alert that is issued upon the detection of abnormalities in the signals from the heart.

16. The system of claim 1 wherein the system is further configured to perform an alarm test at a defined inter-test interval.

17. The device of claim of 1 wherein the second alarm signal is selected based upon the type of abnormalities detected in the patient'"'"'s medical condition.

18. The system of claim 1 wherein the second alarm signal is selected based upon the alarm test results.

19. The device of claim of 1 wherein the alarm test is programmable.

20. The implanted medical device of claim 1, wherein the external device is an external patient controller configured with an alarm test module designed to send and receive commands and data associated with at least one type of alarm test.

21. The implanted medical device of claim 1, wherein the external device is a physician programmer configured with an alarm test module designed to send and receive commands and data associated with at least one type of alarm test.