Non-invasive detection of phrenic nerve stimulation

• US 9,776,009 B2
• Filed: 03/20/2014
• Issued: 10/03/2017
• Est. Priority Date: 03/20/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ghosh, Subham, Splett, Vincent
• Primary Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US14/220,733
• Publication Number:
  US 20150265840A1
• Time in Patent Office: 1,293 Days
• Field of Search: 607 27, 607 28
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/7235 Details of waveform analysis A61B5/349 takes precedence
• CPC Class Codes: A61B 5/7267 involving training the classification device
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

Systems, methods, and graphical user interfaces are described herein for non-invasively detecting phrenic nerve stimulation during cardiac pacing therapy. Phrenic nerve stimulation information may be generated for one or more electrical pacing vectors at one or more power configurations. The phrenic nerve stimulation information may be displayed to a user for use in configuring and/or evaluating cardiac pacing therapy.

Claims

1. A non-invasive system for detecting phrenic nerve stimulation during pacing therapy comprising:

external electrode apparatus comprising a plurality of external electrodes configured to be located proximate tissue of a patient; and

computing apparatus coupled to the external electrode apparatus and configured to;

monitor electrical activity using two or more external electrodes of the plurality of external electrodes during delivery of pacing therapy, wherein such monitoring results in two or more electrical signals measured using the two or more external electrodes indicative of whether or not phrenic nerve stimulation occurred as a result of the pacing therapy delivered, and

determine whether the patient'"'"'s phrenic nerve is stimulated by the pacing therapy based on the monitored electrical activity, wherein determination of whether the patient'"'"'s phrenic nerve is stimulated comprises comparison of each of the electrical signals measured using the two or more external electrodes or a value determined from the electrical signals measured using the two or more external electrodes to a phrenic nerve stimulation threshold.

2. The system of claim 1, wherein the two or more external electrodes of the plurality of external electrodes are configured to be located on the anterior torso of the patient.

3. The system of claim 1, wherein the external electrode apparatus comprises one of a band and a vest configured to be worn about the torso of the patient, wherein the plurality of external electrodes are coupled to the band or vest.

4. The system of claim 1, wherein monitoring electrical activity using two or more external electrodes of the plurality of external electrodes during delivery of pacing therapy comprises monitoring electrical activity using two or more external electrodes of the plurality of external electrodes for a selected time period after delivery of a pacing pulse.

5. The system of claim 1, wherein determining whether the patient'"'"'s phrenic nerve is stimulated by the pacing therapy comprises comparing a maximum peak-to-peak amplitude of the monitored electrical activity to a threshold value.

6. The system of claim 5, wherein the threshold value is based on baseline measurements monitored using one or more external electrodes of the plurality of external electrodes during one of intrinsic rhythm and atrial pacing, wherein the threshold value is greater than or equal to 3 times a baseline value based on the baseline measurements.

7. The system of claim 1, wherein determining whether the patient'"'"'s phrenic nerve is stimulated by the pacing therapy comprises determining that the patient'"'"'s phrenic nerve is stimulated if the monitored electrical activity from a selected percentage of the two or more external electrodes used to monitor electrical activity during delivery of pacing therapy is indicative of phrenic nerve stimulation.

8. A non-invasive method for detecting phrenic nerve stimulation during pacing therapy comprising:

monitoring electrical activity using two or more external electrodes of a plurality of external electrodes during delivery of pacing therapy, wherein the plurality of external electrodes located proximate tissue of the patient, and further wherein such monitoring results in two or more electrical signals measured using the two or more external electrodes indicative of whether or not phrenic nerve stimulation occurred as a result of the pacing therapy delivered; and

determining whether the patient'"'"'s phrenic nerve is stimulated by the pacing therapy based on the monitored electrical activity, wherein determining whether the patient'"'"'s phrenic nerve is stimulated by the pacing therapy based on the monitored electrical activity comprises comparing each of the electrical signals measured using the two or more external electrodes or a value determined from the electrical signals measured using the two or more external electrodes to a phrenic nerve stimulation threshold.

9. The method of claim 8, wherein the two or more external electrodes of the plurality of external electrodes are configured to be located on the anterior torso of the patient.

10. The method of claim 8, wherein monitoring electrical activity using two or more external electrodes of the plurality of external electrodes during delivery of pacing therapy comprises monitoring electrical activity using two or more external electrodes of the plurality of external electrodes for a selected time period after delivery of a pacing pulse.

11. The method of claim 8, wherein determining whether the patient'"'"'s phrenic nerve is stimulated by the pacing therapy comprises comparing a maximum peak-to-peak amplitude of the monitored electrical activity to a threshold value.

12. The method of claim 11, wherein the threshold value is based on baseline measurements monitored using one or more external electrodes of the plurality of external electrodes during one of intrinsic rhythm and atrial pacing, wherein the threshold value is greater than or equal to 3 times a baseline value based on the baseline measurements.

13. The method of claim 8, wherein determining whether the patient'"'"'s phrenic nerve is stimulated by the pacing therapy comprises determining that the patient'"'"'s phrenic nerve is stimulated if the monitored electrical activity from a selected percentage of the two or more external electrodes used to monitor electrical activity during delivery of pacing therapy is indicative of phrenic nerve stimulation.

14. A non-invasive system for detecting phrenic nerve stimulation during pacing therapy comprising:

electrode means for monitoring electrical activity of a patient during delivery of pacing therapy, wherein the electrode means comprises two or more external electrodes configured to be located on the anterior torso of the patient; and

computing means for determining whether the patient'"'"'s phrenic nerve is stimulated by the pacing therapy based on monitored electrical activity, wherein the electrode means for monitoring electrical activity using the two or more external electrodes results in two or more electrical signals measured using the two or more external electrodes indicative of whether or not phrenic nerve stimulation occurred as a result of the pacing therapy delivered, and wherein the computing means comprises means for determining whether the patient'"'"'s phrenic nerve is stimulated by the pacing therapy based on the monitored electrical activity, wherein the means for determining whether the patient'"'"'s phrenic nerve is stimulated comprises means for comparing each of the electrical signals measured using the two or more external electrodes or a value determined from the electrical signals measured using the two or more external electrodes to a phrenic nerve stimulation threshold.

15. A non-invasive system for use in detecting phrenic nerve stimulation during pacing therapy using one or more pacing electrodes of a plurality of pacing electrodes defining one or more of electrical pacing vectors, the system comprising:

external electrode apparatus comprising a plurality of external electrodes configured to be located proximate tissue of a patient;

display apparatus comprising a graphical user interface, wherein the graphical user interface is configured to present information for use in assisting a user in at least one of evaluating pacing therapy and configuring pacing therapy; and

computing apparatus coupled to the external electrode apparatus and display apparatus and configured to;

monitor electrical activity using two or more external electrodes of the plurality of external electrodes during delivery of pacing therapy using each electrical pacing vector of one or more electrical pacing vectors, wherein such monitoring results in two or more electrical signals measured using the two or more external electrodes indicative of whether or not phrenic nerve stimulation occurred as a result of the pacing therapy delivered,

determine whether the patient'"'"'s phrenic nerve is stimulated by the pacing therapy delivered using each electrical pacing vector of the one or more electrical pacing vectors based on the monitored electrical activity, wherein determination of whether the patient'"'"'s phrenic nerve is stimulated comprises comparison of each of the electrical signals measured using the two or more external electrodes or a value determined from the electrical signals measured using the two or more external electrodes to a phrenic nerve stimulation threshold, and

display, on the graphical user interface, phrenic nerve stimulation information for the one or more electrical pacing vectors for use in assisting a user in at least one of evaluating pacing therapy and configuring pacing therapy.

16. The system of claim 15, wherein the two or more electrodes of the plurality of external electrodes are configured to be located on the anterior torso of the patient.

17. The system of claim 15, wherein the external electrode apparatus comprises one of a band and a vest configured to be worn about the torso of the patient, wherein the plurality of external electrodes are coupled to the band or vest.

18. The system of claim 15, wherein monitoring electrical activity using two or more external electrodes of the plurality of external electrodes during delivery of pacing therapy comprises monitoring electrical activity using two or more external electrodes of the plurality of external electrodes for a selected time period after delivery of a pacing pulse.

19. The system of claim 15, wherein determining whether the patient'"'"'s phrenic nerve is stimulated by the pacing therapy comprises comparing a maximum peak-to-peak amplitude of the monitored electrical activity to a threshold value.

20. The system of claim 15, wherein determining whether the patient'"'"'s phrenic nerve is stimulated by the pacing therapy comprises determining that the patient'"'"'s phrenic nerve is stimulated if the monitored electrical activity from a selected percentage of the two or more external electrodes used to monitor electrical activity during delivery of pacing therapy is indicative of phrenic nerve stimulation.

21. The system of claim 15, wherein the computing apparatus is further configured to display, on the graphical user interface, phrenic nerve stimulation information for the one or more electrical pacing vectors proximate a graphical depiction of at least a portion of anatomy of the patient'"'"'s heart.

22. The system of claim 15, wherein the delivery of pacing therapy using each electrical pacing vector of one or more electrical pacing vectors comprises delivery of pacing therapy using each electrical pacing vector configured in each power configuration of a plurality of different power configurations, wherein the computing apparatus is further configured to display, on the graphical user interface, power configuration information for at least each electrical pacing vector of the one or more electrical pacing vectors that is determined to stimulate the patient'"'"'s phrenic nerve.

23. A non-invasive system for detecting phrenic nerve stimulation during pacing therapy comprising:

at least one implantable electrode;

external electrode apparatus comprising a plurality of external electrodes configured to be located proximate tissue of a patient; and

computing apparatus coupled to the external electrode apparatus and configured to;

control delivery of pacing therapy using the at least one implantable electrode,

monitor electrical activity using two or more external electrodes of the plurality of external electrodes during delivery of pacing therapy using the at least one implantable electrode, wherein such monitoring results in two or more electrical signals measured using the two or more external electrodes indicative of whether or not phrenic nerve stimulation occurred as a result of the pacing therapy delivered, and

determine whether the patient'"'"'s phrenic nerve is stimulated by the delivered pacing therapy based on the two or more electrical signals measured using the two or more external electrodes, wherein the determination of whether the patient'"'"'s phrenic nerve is stimulated comprises comparing the two or more electrical signals measured using the two or more external electrodes or a value determined from the two or more electrical signals measured using the two or more external electrodes to a phrenic nerve stimulation threshold.

24. The system of claim 23, wherein determining whether the patient'"'"'s phrenic nerve is stimulated by the delivered pacing therapy comprises comparing a maximum peak-to-peak amplitude of the monitored electrical activity to a threshold value.

25. The system of claim 24, wherein determining whether the patient'"'"'s phrenic nerve is stimulated by the delivered pacing therapy comprises determining that the patient'"'"'s phrenic nerve is stimulated if the monitored electrical activity from a selected percentage of the two or more external electrodes used to monitor electrical activity during delivery of pacing therapy is indicative of phrenic nerve stimulation.