Implanted lead analysis system and method

• US 9,764,144 B2
• Filed: 07/29/2015
• Issued: 09/19/2017
• Est. Priority Date: 07/29/2014
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Mahajan, Deepa, Perschbacher, David L., Sharma, Arjun D.
• Primary Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US14/811,901
• Publication Number:
  US 20160030752A1
• Time in Patent Office: 783 Days
• Field of Search: 607 27, 607 5, 607 9, 607 28, 600508
• CPC Class Codes: A61B 5/276 Protection against electrode failure
• CPC Class Codes: A61B 5/29 for permanent or long-term implantation
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/37 Monitoring; Protecting

Abstract

Implanted medical device data is received, where the data was sensed by a first lead portion and a sensor over a time period. The number of detected noise events sensed by the first lead portion is counted based on applying first noise detection criteria to the data sensed by the first lead portion. The number of detected noise events over the sensor is counted based on applying second noise detection criteria to the data sensed by the sensor. The mean number of detected noise events is calculated for the first lead portion and sensor based on the number of noise events sensed by the first lead portion and the number of noise events sensed by the sensor. Potential lead failure in the first lead is recorded if the number of detected noise events over the first lead is greater than the mean number of noise events by at least 5%.

Claims

1. A method comprising:

receiving, via a first lead portion and a sensor, implanted medical device data, sensed over a period of time of one day;

applying, via a processor, first noise detection criteria to the medical device data sensed by the first lead portion;

counting, via the processor, the number of detected noise events sensed by the first lead portion over the time period based on the first noise detection criteria;

applying, via the processor, second noise detection criteria to the medical device data sensed by the sensor;

counting, via the processor, the number of detected noise events over the sensor over the time period based on the second noise detection criteria;

calculating, via the processor, the mean number of detected noise events over the time period, wherein at least the number of detected noise events sensed by the first lead portion and the number of detected noise events sensed by the sensor are included in the mean calculation;

recording, via the processor, a determination of potential lead failure in the first lead if the number of detected noise events over the first lead over the time period is greater than the mean number of noise events by at least 5%; and

displaying, on a user interface, an alert representing the determination of potential lead failure of the first lead.

2. The method of claim 1, further comprising recording a determination of potential electro-magnetic interference when the number of detected noise events over the first lead is within a margin of the mean number of noise events and the mean number of noise events is above a threshold.

3. The method of claim 1, wherein the first lead portion and the sensor are different locations along a single lead.

4. The method of claim 1, wherein the first lead portion and the sensor are different leads.

5. The method of claim 1, wherein the first noise detection criteria defines a first threshold number of beats that are faster than a first fast beat threshold and the second noise detection criteria defines a second threshold number of beats that are faster than second fast beat threshold, wherein the second fast beat threshold is different than the first fast beat threshold.

6. The method of claim 5, wherein the sensor is a right ventricular lead and the second fast beat threshold is 160 milliseconds.

7. The method of claim 5, wherein the sensor is a left ventricular lead and the second fast beat threshold is 275 milliseconds.

8. The method of claim 5, wherein the sensor is a right atrial lead and the second fast beat threshold is 110 milliseconds.

9. The method of claim 5, wherein the first threshold number of beats is four beats within an episode.

10. The method of claim 1, wherein the time period is at between 2 days and 30 days.

11. The method of claim 1, further comprising recording a determination representing potential lead failure in the sensor if the number of detected noise events over the sensor over the time period is greater than the mean number of noise events.

12. A system comprising:

an implantable medical device having a plurality of sensors configured to sense patient physiological data, wherein the plurality of sensors comprise at least one lead;

processing circuitry configured to;

receive the patient physiological data from the plurality of sensors over a period of time of one day,

apply noise detection criteria to patient physiological data sensed by each of the plurality sensors to count the number of noise events over each sensor,

calculate the mean number of noise events from all of the sensors over the period of time, and

compare the number of noise events from each of the at least one lead to the mean number of noise events over the period of time; and

a user interface in communication with the processing circuitry configured to display an alert representing potential lead failure for each of the at least one lead that had a total number of noise events greater than the mean number of noise events over the period of time.

13. The system of claim 12, wherein the processing circuitry is disposed within the implantable medical device.

14. The system of claim 12, wherein a portion of the processing circuitry is disposed within the implantable medical device and another portion of the processing circuitry is disposed in a communicator that is configured for communication with the implantable medical device.

15. The system of claim 12, wherein the processing circuitry is configured to apply different noise detection criteria to each of the sensors.

16. The system of claim 12, wherein the processing circuitry is configured to receive the patient physiological data that was sensed over a time period between 2 days and 30 days.

17. The system of claim 12, wherein the user interface is configured to display an alert of potential electro-magnetic interference when the number of detected noise events over the at least one lead is within a margin of the mean number of noise events and the mean number of noise events is above a threshold.

18. The system of claim 15, wherein the at least one lead comprises a first lead that is a right atrial lead and the processing circuitry is configured to apply a first noise detection criteria to the first lead that comprises sensing a plurality of sensed beats within an episode that are faster than 110 milliseconds.

19. The system of claim 18, wherein the at least one lead comprises a second lead that is a left ventricular lead and the processing circuitry is configured to apply a second noise detection criteria to the second sensor that comprises sensing a plurality of sensed beats within an episode that are faster than 275 milliseconds.

20. The system of claim 12, wherein the noise detection criteria requires at least four beats within an episode to be faster than a threshold.