Medical device failure detection and warning system

• US 9,095,314 B2
• Filed: 08/16/2013
• Issued: 08/04/2015
• Est. Priority Date: 11/07/2003
• Status: Active Grant

• Current Assignee: Flint Hills Scientific, LLC
• Original Assignee: Flint Hills Scientific, LLC
• Inventors: Osorio, Ivan, Frei, Mark G., Bhavaraju, Naresh C.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US13/968,813
• Publication Number:
  US 20130338450A1
• Time in Patent Office: 718 Days
• Field of Search: 607/45, 600/544
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/242 Detecting biomagnetic fields, e.g. magnetic fields produced by bioelectric currents
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 7/00 Instruments for auscultation
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A failure detection and warning system for monitoring a medical device wherein the system structured to passively or actively detect faults occurring in the medical device being monitored, and wherein the fault includes an unprogrammed and/or undesired shut off of the medical device being monitored or an unprogrammed and/or undesired shut-off of the output of the medical device being monitored by the system.

Claims

1. A failure detection system comprising:

a first medical device comprising;

one or more memory devices;

one or more sensors; and

one or more processors configured to;

receive one or more signals from a second medical device, the second medical device configured to detect an epileptic seizure characteristic;

determine a presence and a quality of the one or more signals;

determine that the second medical device is in a first condition based on the determined signal presence and the determined signal quality where the first condition is that one or more operations of the second medical device have been modified inadvertently; and

determine that the second medical device is in a second condition based on the determined signal presence and the determined signal quality where the second condition is that the second medical device is operating properly.

2. The failure detection system of claim 1, wherein the second medical device is configured to determine a patient condition.

3. The failure detection system of claim 2, wherein the patient condition is a seizure condition.

4. The failure detection system of claim 1, further comprising an implantable medical device where the implantable medical device is configured to detect an epileptic seizure characteristic, wherein the one or more processors of the first medical device are further configured to:

receive one or more signals from the implantable medical device;

determine a presence and a quality of the one or more implantable medical device signals;

determine that the implantable medical device is in a first implantable medical device condition based on the determined implantable medical device signal presence and the determined implantable medical device signal quality where the first implantable medical device condition is that one or more operations of the implantable medical device have been modified inadvertently;

determine that the implantable medical device is in a second implantable medical device condition based on the determined implantable medical device signal presence and the determined implantable medical device signal quality where the second implantable medical device condition is that the implantable medical device is operating properly; and

wherein the one or more signals from the implantable medical device are based on a non-invasively detected electromagnetic field.

5. The failure detection system of claim 1, further comprising an implantable medical device where the implantable medical device is configured to detect an epileptic seizure characteristic, wherein the one or more processors of the first medical device are further configured to:

receive one or more signals from the implantable medical device;

determine a presence and a quality of the one or more implantable medical device signals;

determine that the implantable medical device is in a first implantable medical device condition based on the determined implantable medical device signal presence and the determined implantable medical device signal quality where the first implantable medical device condition is that one or more operations of the implantable medical device have been modified inadvertently;

determine that the implantable medical device is in a second implantable medical device condition based on the determined implantable medical device signal presence and the determined implantable medical device signal quality where the second implantable medical device condition is that the implantable medical device is operating properly; and

wherein the one or more signals from the implantable medical device are based on one or more temperature changes.

6. The failure detection system of claim 1, further comprising an implantable medical device where the implantable medical device is configured to detect an epileptic seizure characteristic, wherein the one or more processors of the first medical device are further configured to:

receive one or more signals from the implantable medical device;

determine a presence and a quality of the one or more implantable medical device signals;

determine that the implantable medical device is in a first implantable medical device condition based on the determined implantable medical device signal presence and the determined implantable medical device signal quality where the first implantable medical device condition is that one or more operations of the implantable medical device have been modified inadvertently;

determine that the implantable medical device is in a second implantable medical device condition based on the determined implantable medical device signal presence and the determined implantable medical device signal quality where the second implantable medical device condition is that the implantable medical device is operating properly; and

wherein the one or more signals from the implantable medical device are based on one or more acoustic signals.

7. The failure detection system of claim 1, further comprising an implantable medical device where the implantable medical device is configured to detect an epileptic seizure characteristic, wherein the one or more processors of the first medical device are further configured to:

receive one or more signals from the implantable medical device;

determine a presence and a quality of the one or more implantable medical device signals;

determine that the implantable medical device is in a first implantable medical device condition based on the determined implantable medical device signal presence and the determined implantable medical device signal quality where the first implantable medical device condition is that one or more operations of the implantable medical device have been modified inadvertently;

determine that the implantable medical device is in a second implantable medical device condition based on the determined implantable medical device signal presence and the determined implantable medical device signal quality where the second implantable medical device condition is that the implantable medical device is operating properly; and

wherein the one or more signals from the implantable medical device are based on telemetry data.

8. The failure detection system of claim 1, wherein the one or more processors are further configured to provide a warning to a remote device based on at least one of the presence and the quality of the one or more signals.

9. The failure detection system of claim 8, wherein the remote device is a centralized monitoring center.

10. The failure detection system of claim 1, wherein the one or more processors are further configured to initiate a 911 call based on at least one of the presence and the quality of the one or more signals.

11. The failure detection system of claim 1, wherein the second medical device has been modified inadvertently by one or more outside interferences.

12. The failure detection system of claim 1, wherein the one or more processors are further configured to generate a warning based on the first condition.

13. The failure detection system of claim 1, wherein the determined signal quality is based on at least one of a decrease in one or more signals and an increase in one or more signals.

14. The failure detection system of claim 1, wherein the second medical device is monitoring one or more non-biological signals from an implantable medical device.

15. The failure detection system of claim 1, wherein the one or more processors are further configured to receive the one or more signals at prescribed times.

16. The failure detection system of claim 1, wherein the one or more processors are further configured to reset one or more second medical device parameters after the inadvertent change has been detected.

17. The failure detection system of claim 1, wherein the first condition is that one or more second medical device parameters have been modified inadvertently.

18. The failure detection system of claim 1, wherein the first condition is that one or more second medical device functions have been modified inadvertently.

19. The failure detection system of claim 1, wherein the second medical device is an implantable medical device.

20. A centralized monitoring system comprising:

a first monitoring device comprising;

one or more memory devices;

one or more sensors; and

one or more processors configured to;

receive one or more signals from at least one of an implantable medical device and a second monitoring device, the implantable medical device and the second monitoring device being configured to detect an epileptic seizure characteristic;

determine a presence and a quality of the one or more signals;

determine that the second monitoring device is in a first condition based on the determined second monitoring device signal presence and the determined second monitoring device signal quality where the first condition is that one or more operations of the second monitoring device have been modified inadvertently; and

determine that the second monitoring device is in a second condition based on the determined second monitoring device signal presence and the determined second monitoring device signal quality where the second condition is that the second monitoring device is operating properly.

21. The centralized monitoring system of claim 20, wherein the one or more signals are based on telemetry data.

22. The centralized monitoring system of claim 20, wherein the one or more processors are further configured to provide a warning to a remote device based on at least one of the presence and the quality of the one or more signals.

23. The centralized monitoring system of claim 20, wherein the one or more processors are further configured to initiate a 911 call based on at least one of the presence and the quality of the one or more signals.

24. The centralized monitoring system of claim 20, wherein the one or more processors are further configured to activate lights based on at least one of the presence and the quality of the one or more signals.

25. The centralized monitoring system of claim 20, wherein the one or more processors are further configured to activate speakers based on at least one of the presence and the quality of the one or more signals.

26. The centralized monitoring system of claim 20, wherein the one or more processors are further configured to transmit data to one or more external processors for additional analysis based on at least one of the presence and the quality of the one or more signals.

27. The centralized monitoring system of claim 20, wherein the one or more processors are further configured to store adverse event logging data based on at least one of the presence and the quality of the one or more signals.

28. The centralized monitoring system of claim 20, wherein the one or more processors are further configured to initiate one or more event buttons based on at least one of the presence and the quality of the one or more signals.

29. A monitoring system comprising:

an implantable medical device;

an external medical monitoring device including one or more memory units, one or more sensors, and one or more external medical monitoring device processors configured to;

receive one or more signals from the implantable medical device;

determine a presence and a quality of the one or more signals;

determine that the implantable medical device is in a first condition based on the determined implantable medical device signal presence and the determined implantable medical device signal quality where the first condition is that one or more operations of the implantable medical device have been modified inadvertently; and

determine that the implantable medical device is in a second condition based on the determined implantable medical device signal presence and the determined implantable medical device signal quality where the second condition is that the implantable medical device is operating properly; and

a centralized monitoring device including one or more memory modules, one or more sensors, and one or more centralized monitoring device processors configured to;

receive one or more signals from at least one of the implantable medical device and the external medical monitoring device;

determine the presence and the quality of the one or more signals;

determine that at least one of the implantable medical device and the external monitoring device is in a first condition based on the determined signal presence and the determined signal quality where the first condition is that one or more operations of at least one of the implantable medical device and the external monitoring device have been modified inadvertently; and

determine that at least one of the implantable medical device and the external monitoring device is in a second condition based on the determined signal presence and the determined signal quality where the second condition is that at least one of the implantable medical device and the external monitoring device is operating properly.

30. The monitoring system of claim 29, wherein the implantable medical device is configured to determine a patient condition.

31. The monitoring system of claim 30, wherein the patient condition is a seizure condition.

32. The monitoring system of claim 29, wherein the one or more centralized monitoring device processors are further configured to determine that the implantable medical device is operating within a parameter range.

33. The monitoring system of claim 32, wherein the parameter range is a range where the implantable medical device is operating in a proper state.

34. The monitoring system of claim 29, wherein the one or more external medical monitoring device processors are further configured to provide a warning to a remote device based on at least one of the presence and the quality of the one or more signals.

35. The monitoring system of claim 29, wherein the one or more centralized monitoring device processors are further configured to provide a warning to a remote device based on at least one of the presence and the quality of the one or more signals.