Lead integrity monitoring

Patent metadata

Field	Value
Publication number	US-2017296810-A1
Application number	US-201715486113-A
Country	US
Kind code	A1
Filing date	Apr 12, 2017
Priority date	Apr 13, 2016
Publication date	Oct 19, 2017
Grant date	—

Abstract

A system for lead integrity monitoring includes an implantable medical device (IMD) having a housing enclosing a control circuit; and a lead, having a first sensor. The lead is coupled to the housing and electrically coupled to the control circuit. The system also includes at least one processing device configured to identify a first lead failure alert based on a first set of information; obtain a second set of information generated by a second sensor; perform an evaluation of the first set of information in the context of the second set of information; and confirm or cancel the first lead failure alert based on the evaluation.

First claim

We claim:

1 . A system for monitoring lead integrity, comprising:
an implantable medical device (IMD) configured to be implanted within a patient's body, the IMD comprising:
a housing enclosing a control circuit; and
a lead, having a first sensor, wherein the lead is coupled to the housing and electrically coupled to the control circuit; and
at least one processing device configured to:
identify a first lead failure alert, the first lead failure alert comprising an indication of a potential lead failure based on a first set of information satisfying an alert criterion;
obtain a second set of information generated by a second sensor;
perform an evaluation of the first set of information in the context of the second set of information; and
confirm or cancel the first lead failure alert based on the evaluation.

2 . The system of claim 1 , the first set of information comprising at least one of a first set of impedance data associated with the lead, a set of user input associated with the lead, a set of sensed noise information, a set of pace capture information, a set of sensed intrinsic information, a set of non-sustained tachycardia episode information, and a set of phrenic nerve stimulation information.

3 . The system of claim 2 , the first set of information comprising at least one of a first set of impedance data associated with the lead, wherein the at least one processing device is configured to perform the evaluation by:
determining whether a subset of the first set of impedance data satisfies the alert criterion, wherein the subset of the first set of impedance data corresponds to at least one instance of a fixed value of the second set of information; wherein the processing device is configured to confirm the first lead failure alert if the subset of the first set of impedance data satisfies the alert criterion.

4 . The system of claim 2 , the first set of information comprising at least one of a first set of impedance data associated with the lead, wherein the at least one processing device is configured to perform the evaluation by:
determining a variability of a subset of the first set of impedance data, wherein the subset of the first set of impedance data corresponds to a plurality of instances of a fixed value of the second set of information; wherein the processing device is configured to confirm the first lead failure alert if the variability exceeds a variability threshold.

5 . The system of claim 2 , the first set of information comprising at least one of a first set of impedance data associated with the lead, wherein the first lead failure alert is generated in response to a determination that a first variability exceeds a variability threshold, the first variability comprising a variability of the first set of impedance data, wherein the at least one processing device is configured to perform the evaluation by:
determining a second variability, the second variability comprising a variability of a subset of the first set of impedance data, wherein the subset of the first set of impedance data corresponds to a plurality of instances of a fixed value of the second set of information; and determining a difference between the first variability and the second variability, wherein the processing device is configured to cancel the first lead failure alert if the difference exceeds a difference threshold.

6 . The system of claim 2 , the first set of information comprising at least one of a first set of impedance data associated with the lead, wherein the at least one processing device is configured to perform the evaluation by:
determining a variability of a subset of the first set of impedance data, wherein the subset of the first set of impedance data corresponds to a first extreme value of the second set of information and a second extreme value of the second set of information; wherein the processing device is configured to confirm the first lead failure alert if the variability exceeds a variability threshold.

7 . The system of claim 2 , the first set of information comprising at least one of a first set of impedance data associated with the lead, wherein the first set of impedance data is obtained using a first sampling frequency, and wherein, in response to receiving the first lead failure alert, the at least one processing device is configured to obtain a second set of impedance data using a second sampling frequency, wherein the second sampling frequency is higher than the first sampling frequency.

8 . The system of claim 2 , wherein the second set of information comprises at least one of posture data associated, respiratory data, cardiac cycle data, lead strain data, arm displacement data, and a second set of impedance data, wherein the second set of impedance data is associated with an additional lead.

9 . The system of claim 2 , wherein the at least one processing device is configured to confirm the first lead failure alert by generating a second lead failure alert, the second lead failure alert comprising an instruction configured to cause a display device to present an indication of failure of the lead.

10 . The system of claim 2 , wherein the at least one processing device is configured to:
determine a number of first lead failure alerts received within a specified time period; determine a number of the first lead failure alerts received within the specified time period that were canceled; determine that the number of the first lead failure alerts received within the specified time period that were canceled exceeds an alert threshold; and adjust the alert criterion in response to determining that the number of the first lead failure alerts received within the specified time period that were canceled exceeds the alert threshold.

11 . A system for monitoring lead integrity, comprising:
an implantable medical device (IMD) configured to be implanted within a patient's body, the IMD comprising:
a housing enclosing a control circuit;
a lead, having a first sensor, wherein the lead is coupled to the housing and electrically coupled to the control circuit, wherein the control circuit is configured to obtain a first set of impedance data associated with the lead; and
a first communication component configured to transmit the first set of impedance data; and
an external monitoring device (EMD) configured to be disposed outside of the patient's body, the EMD comprising:
a second communication component configured to receive, from the first communication component, the first set of impedance data; and
a processing device configured to (1) identify a first lead failure alert, the first lead failure alert comprising an indication of a potential lead failure based on a first set of information satisfying an alert criterion, the first set of information comprising the first set of impedance data associated with the lead; (2) obtain a second set of information generated by a second sensor; (3) perform an evaluation of the first set of information in the context of the second set of information; and (4) confirm or cancel the first lead failure alert based on the evaluation.

12 . The system of claim 11 , wherein the second sensor comprises at least one of an accelerometer, a sensor disposed on an additional lead coupled to the housing, a displacement sensor configured to detect arm movement, a strain sensor configured to detect tension in the lead, a respiration sensor, and a heart rate sensor.

13 . A method of monitoring a status of a lead of an implantable medical device (IMD), the method comprising:
identifying a first lead failure alert, the first lead failure alert comprising an indicatio

Assignees

• Cardiac Pacemakers Inc

Inventors

• Thakur Pramodsingh H
• Mahajan Deepa
• An Qi
• Maile Keith R
• Ternes David J
• Shen Zhe

Classifications

• A61N1/37258

  Alerting the patient · CPC title

• A61N1/371

  Capture, i.e. successful stimulation · CPC title

• A61N2001/083

  Monitoring integrity of contacts, e.g. by impedance measurement · CPC title

• A61N1/08 Primary

  Arrangements or circuits for monitoring, protecting, controlling or indicating {(for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925)} · CPC title

• A61N1/37223

  Circuits for electromagnetic coupling · CPC title