Method for monitoring phrenic nerve function

• US 9,724,018 B2
• Filed: 10/27/2011
• Issued: 08/08/2017
• Est. Priority Date: 10/27/2011
• Status: Active Grant

• Current Assignee: Medtronic CryoCath LP (Medtronic Plc)
• Original Assignee: Medtronic CryoCath LP (Medtronic Plc)
• Inventors: Ransom, Scott A., Cho, Yong K., Zhang, Xusheng
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): TRAN, THO Q
• Application Number:
  US13/282,713
• Publication Number:
  US 20130109994A1
• Time in Patent Office: 2,112 Days
• Field of Search: None
• CPC Class Codes: A61B 5/1104 induced by stimuli or drugs; A61B5/1102 takes precedence; investigating medicinal preparations G01N33/15
• CPC Class Codes: A61B 5/7217 of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker

Abstract

Systems and methods for monitoring phrenic nerve function of a patient are disclosed, including, including establishing a diaphragmatic movement value threshold; positioning a diaphragmatic movement sensor on an external surface of an abdomen of the patient; applying a treatment regimen to a tissue region in proximity to the phrenic nerve; measuring a diaphragmatic movement value with the diaphragmatic movement sensor; comparing the measured diaphragmatic movement value to the established diaphragmatic movement value threshold; and generating an alert in response to the comparison.

Claims

1. A method of monitoring phrenic nerve function of a patient during a treatment regimen, the method comprising:

positioning a motion sensor including an accelerometer on an external surface of the patient in proximity to a diaphragm of the patient;

delivering excitation energy to a phrenic nerve of the patient by a stimulation device;

measuring with the accelerometer a slope of amplitude over time of a pre-treatment diaphragm excursion in response to the delivery of excitation energy to the phrenic nerve and an amplitude of a pre-treatment diaphragm excursion in response to the delivery of excitation energy to the phrenic nerve;

establishing a pre-treatment slope of amplitude over time threshold and a pre-treatment amplitude threshold, the pre-treatment slope of amplitude over time threshold and the pre-treatment amplitude threshold being based on one of the pre-treatment slope of amplitude over time and the pre-treatment amplitude;

applying the treatment regimen to a tissue region in proximity to the phrenic nerve with a treatment device;

measuring with the accelerometer an in-treatment slope of amplitude over time and an in-treatment amplitude of an in-treatment diaphragm excursion;

comparing the measured in-treatment slope of amplitude over time and the measured in-treatment amplitude to the established pre-treatment slope of amplitude over time threshold and the established pre-treatment amplitude threshold, the comparison indicating phrenic nerve impairment when at least one of the in-treatment slope of amplitude over time and the in-treatment amplitude is less than the slope of amplitude over time threshold or the amplitude threshold; and

generating an alert when the comparison indicates phrenic nerve impairment.

2. The method of claim 1, further comprising:

establishing a diaphragm electromyogram threshold;

obtaining an electromyogram of the diaphragm;

comparing the obtained electromyogram to the established diaphragm electromyogram threshold; and

generating an alert based at least in part on the comparison.

3. The method of claim 1, wherein the treatment regimen includes ablating cardiac tissue.

4. A medical system for monitoring phrenic nerve function of a patient during a treatment regimen, the medical system comprising:

a motion sensor positionable on an exterior surface of a patient, the motion sensor including an accelerometer;

a stimulation device configured to deliver at least one of electric and magnetic impulses to the patient'"'"'s phrenic nerve;

a treatment device configured to deliver treatment energy to a target tissue site proximate the patient'"'"'s phrenic nerve; and

a controller in communication with the motion sensor and the stimulation device, the controller programmed to;

transmit at least one of electric and magnetic impulses to the stimulation device, the stimulation device delivering the at least one of electric and magnetic impulses to the patient'"'"'s phrenic nerve in a plurality of stimulation pulses to cause a plurality of diaphragm excursions, each of the diaphragm excursions having a peak amplitude;

determine a pacing rate based on the delivery of the plurality of stimulation pulses, the pacing rate being a time interval between peak amplitudes of a first diaphragm excursion and a second diaphragm excursion;

establish a measurement time interval for each of the plurality of stimulation pulses, the measurement time interval for each of the plurality of stimulation pulses being longer than the pacing rate;

determine whether a diaphragm excursion is produced during each measurement time interval as a result of delivery of each of the plurality of stimulation pulses;

generate a first alert when the controller determines an absence of a diaphragm excursion during the measurement time interval, an absence of a diaphragm excursion indicating phrenic nerve impairment;

calculate a threshold slope and a threshold amplitude of a pre-treatment diaphragm excursion based on a signal received from the accelerometer in response to the delivery of the plurality of stimulation pulses;

transmit treatment energy to the treatment device, the treatment device delivering the treatment energy to the target tissue site;

calculate an in-treatment slope and an in-treatment amplitude of a diaphragm excursion based on a signal received from the accelerometer;

compare the in-treatment slope and the in-treatment amplitude to the threshold slope and the threshold amplitude, the comparison indicating phrenic nerve impairment when at least one of the in-treatment slope and the in-treatment amplitude is less than the threshold slope or the threshold amplitude;

generate a second alert when the comparison indicates phrenic nerve impairment; and

modify delivery of treatment energy when the comparison indicates phrenic nerve impairment.

5. The medical system of claim 4, wherein the motion sensor includes a plurality of accelerometers.

6. The medical system of claim 4, wherein the each of the first alert and the second alert is at least one of an audible or visual alert.

7. The medical system of claim 4, further comprising a tissue treatment device in communication with the controller.

8. The medical system of claim 7, wherein the controller is programmed to modify operation of the tissue treatment device based at least in part on the comparison.