Medical device failure detection and warning system

• US 8,515,538 B1
• Filed: 06/13/2008
• Issued: 08/20/2013
• 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:
  US12/157,955
• Time in Patent Office: 1,894 Days
• Field of Search: 607/29, 607/28, 607/17, 607/18
• US Class Current: 607/29
• 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 5/4094 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 includes means 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 and warning system for monitoring a medical device, comprising one or more processors configured to passively or actively detect one or more faults occurring in the medical device being monitored, the failure detection and warning system being external to the medical device, wherein the one or more faults includes at least one of an unprogrammed shut off of the medical device being monitored or an unprogrammed shut-off of an output of the medical device being monitored by the failure detection and warning system, the one or more processors further configured to utilize a monitoring hierarchy structure, the monitoring hierarchy structure configured to include a first priority relating to the medical device being in an unprogrammed off state, the monitoring hierarchy structure further configured to include a second priority relating to an unprogrammed off state of the one or more outputs of the medical device, wherein the first priority is a higher priority than the second priority.

2. The failure detection and warning system as described in claim 1, wherein the failure detection and warning system is communicatively connected to the medical device.

3. The failure detection and warning system as described in claim 2, wherein the communicative connection is wireless.

4. The failure detection and warning system as described in claim 2, wherein the communicative connection includes at least one wire or fiber.

5. The failure detection and warning system as described in claim 1, wherein the failure detection and warning system includes electrical, electromagnetic, noise, temperature or acoustic sensors configured to sense one or more active states of the medical device.

6. The failure detection and warning system as described in claim 1, wherein the failure detection and warning system includes electrical, electromagnetic, noise, temperature or acoustic sensors configured to sense one or more outputs of the medical device.

7. The failure detection and warning system as described in claim 1, wherein the failure detection and warning system includes at least one circuit configured to detect a presence of activity in the medical device.

8. The failure detection and warning system as described in claim 1, wherein the failure detection and warning system includes components configured to operatively detect events occurring continuously in the medical device.

9. The failure detection and warning system as described in claim 1, wherein the failure detection and warning system includes components configured to operatively detect events occurring periodically in the medical device.

10. The failure detection and warning system as described in claim 1, wherein the failure detection and warning system includes components configured to operatively detect events occurring randomly in the medical device.

11. The failure detection and warning system as described in claim 1, wherein the failure detection and warning system monitors at least one medical device that is external to, portable, attached to, or implanted within a subject and wherein the medical device is used for the purpose of diagnosis, monitoring, or delivery of therapy to the subject or to detect, predict, treat, log, or quantify an occurrence of or probability of the occurrence of an event in an organ or in a body of the subject.

12. The failure detection and warning system as described in claim 1, wherein in response to a determination of the failure detection and warning system of an occurrence of an event, the failure detection and warning system is configured to operatively:

(a) initiate a sequence of activities to determine an occurrence of an action by the medical device; and

(b) activate an alarm, if such action by the medical device is not detected by the failure detection and warning system.

13. The failure detection and warning system as described in claim 12, wherein the event is an elapsed pre-specified period of time.

14. The failure detection and warning system as described in claim 12, wherein the action is a continuous, periodic, intermittent, randomly occurring, open-loop, or contingent action.

15. The failure detection and warning system as described in claim 1, wherein, in response to detection of an unprogrammed cessation of activity of the medical device, the failure detection and warning system is configured to operatively activate an alarm.

16. The failure detection and warning system as described in claim 15, wherein the alarm includes a beeper, a tickler stimulator, heating element, 911-calling mechanism or telemetry to a remote monitoring station.

17. The failure detection and warning system of claim 1, wherein the one or more processors is further configured to transmit a first warning associated with the first priority and a second warning associated with the second priority.

18. The failure detection and warning system of claim 17, wherein the first warning is different than a warning triggered by the medical device being in proximity to an interference source.

19. The failure detection and warning system of claim 18, wherein the second warning is different than the warning triggered by the medical device being in proximity to an interference source.

20. The failure detection and warning system of claim 17, wherein the second warning is different than a warning triggered by the medical device being in proximity to an interference source.

21. The failure detection and warning system of claim 1, wherein the failure detection and warning system is further configured to reset the medical device.

22. The failure detection and warning system of claim 1, wherein the failure detection and warning system is further configured to log one or more events associated with the medical device.

23. The failure detection and warning system as described in claim 1, wherein the failure detection and warning system further includes at least one of an electrical sensor, an electromagnetic sensor, a noise sensor, a temperature sensor, and an acoustic sensor configured to sense environmental interference.

24. A failure detection and warning system for monitoring a medical device, comprising one or more processors configured to passively or actively detect one or more faults occurring in the medical device being monitored, the failure detection and warning system being external to the medical device, wherein the one or more faults includes at least one of an unprogrammed shut off of the medical device being monitored or an unprogrammed shut-off of an output of the medical device being monitored by the failure detection and warning system, the one or more processors further configured to utilize a monitoring hierarchy structure, the monitoring hierarchy structure configured to include a first priority relating to the medical device being in an unprogrammed off state, the monitoring hierarchy structure further configured to include a second priority relating to an unprogrammed off state of the one or more outputs of the medical device, wherein the first priority is a higher priority than the second priority, the failure detection and warning system also comprising:

(a) a clock mechanism; and

(b) a memory configured to operatively log at least one detected failure of the medical device, the log including at least one of a time from the clock mechanism which is indicative of a time of a detected failure of the medical device, a type of detected failure of the medical device, a type of corrective action taken by the failure detection and warning system, a response of the medical device to the corrective action, and a time of the response of the medical device to the corrective action.

25. A failure detection and warning system for monitoring a medical device, comprising one or more processors configured to passively or actively detect one or more faults occurring in the medical device being monitored, the failure detection and warning system being external to the medical device, wherein the one or more faults includes at least one of an unprogrammed shut off of the medical device being monitored or an unprogrammed shut-off of an output of the medical device being monitored by the failure detection and warning system, the one or more processors further configured to utilize a monitoring hierarchy structure, the monitoring hierarchy structure configured to include a first priority relating to the medical device being in an unprogrammed off state, the monitoring hierarchy structure further configured to include a second priority relating to an unprogrammed off state of the one or more outputs of the medical device, wherein the first priority is a higher priority than the second priority, the failure detection and warning system also comprising an insulating element which is configured to insulate the failure detection and warning system from electromagnetic interference, or filters to protect the failure detection and warning system from electromagnetic interference.