Method of CMAP monitoring

• US 10,064,564 B2
• Filed: 08/23/2013
• Issued: 09/04/2018
• Est. Priority Date: 08/23/2013
• Status: Active Grant

• Current Assignee: Medtronic CryoCath LP (Medtronic Plc)
• Original Assignee: Medtronic CryoCath LP (Medtronic Plc)
• Inventors: Kowalski, Marcin, Ransom, Scott A., Coulombe, Nicolas
• Primary Examiner(s): McCrosky, David J
• Application Number:
  US13/974,639
• Publication Number:
  US 20150057563A1
• Time in Patent Office: 1,838 Days
• Field of Search: 600529, 600534, 600536, 600546, 600554, 606 21, 606 34, 607 42
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 2017/00044 Sensing electrocardiography, i.e. ECG
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00708 switching the power on or off
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence

Abstract

A method and system for monitoring phrenic nerve function and preventing phrenic nerve injury during cardiac ablation. The system includes a pacing device operable to transmit stimulation energy to the phrenic nerve through target tissue proximate the phrenic nerve, a plurality of assessment electrodes operable to make comparisons between baseline, real-time, and predetermined threshold values for CMAP signal amplitude and amplitude over time. The processing device may be connected to an ablation console, and the processing device may interrupt or adjust an ablation procedure controlled by the ablation console and/or generate a system alert in response to one of these comparisons, if the comparison indicates phrenic nerve injury. The method includes applying stimulation energy to the phrenic nerve, recording diaphragmatic CMAP signals in response to the stimulation energy, and adjusting an ablation procedure and/or automatically generating a system alert in response to comparisons performed by the processing device.

Claims

1. A system for monitoring phrenic nerve function in response to stimulation energy, the system comprising:

a stimulation energy source;

a pacing device including at least one pacing electrode in communication with the stimulation energy source, the at least one pacing electrode being operable to transmit the stimulation energy to the phrenic nerve through a target tissue proximate the phrenic nerve;

a console including a foot switch and at least one of an energy generator and a cryogenic fluid source in communication with the foot switch;

a plurality of assessment electrodes operable to detect diaphragmatic compound motor action potential (CMAP) signals in response to the stimulation energy; and

a processing device including a microcontroller, the microcontroller being in direct communication with the foot switch and programmed to determine, based on the CMAP signals detected by the plurality of assessment electrodes before a delivery of ablation energy, at least one of a baseline amplitude value for the diaphragmatic CMAP signals and a baseline amplitude over time value for the diaphragmatic CMAP signals, the microcontroller also being programmed to;

(a) assess in real time at least one of a treatment amplitude value for the diaphragmatic CMAP signals and a treatment amplitude over time value for the diaphragmatic CMAP;

(b) compare the baseline amplitude value for the diaphragmatic CMAP signals and the treatment amplitude value for the diaphragmatic CMAP signals;

(c) compare the treatment amplitude value for the diaphragmatic CMAP signals to a predetermined threshold amplitude value for the diaphragmatic CMAP signals;

(d) compare the baseline amplitude over time value for the diaphragmatic CMAP signals and the treatment amplitude over time value for the diaphragmatic CMAP;

(e) compare the treatment amplitude over time value for the diaphragmatic CMAP signals to a predetermined threshold amplitude over time value for the diaphragmatic CMAP; and

(f) automatically operate the foot switch in response to at least one of (a)-(e) to at least one of adjust an amount of energy delivered from the energy generator and adjust a flow of cryogenic fluid from the cryogenic fluid source.

2. The system of claim 1, wherein the microcontroller is programmed to average the diaphragmatic CMAP signals.

3. The system of claim 1, wherein the microcontroller is further programmed to automatically generate a system alert when at least one alert criterion occurs, the alert criterion being selected from the group consisting of:

the CMAP signals are out-of-phase between assessment electrodes;

the baseline CMAP signal amplitude is low relative to a running average of CMAP signal amplitudes; and

stimulation energy signals are not detected by the processing device.

4. The system of claim 1, wherein the microcontroller is further programmed to automatically generate a system alert when at least one alert criterion occurs, the alert criterion being selected from the group consisting of:

the treatment amplitude value is less than the threshold amplitude value; and

the treatment amplitude over time value is less than the threshold amplitude over time value.

5. The system of claim 4, wherein the microcontroller automatically generates a system alert when the treatment amplitude value is equal to the threshold amplitude value.

6. The system of claim 4, wherein microcontroller automatically generates a system alert when the treatment amplitude value is less than the baseline amplitude by between 30% to 35%.

7. The system of claim 4, wherein the microcontroller automatically generates a system alert when the treatment amplitude over time value is less than the threshold amplitude over time value.

8. The system of claim 1, wherein the system is in communication with a treatment system, the treatment system including the console.

9. The system of claim 8, wherein the treatment system further includes a treatment device coupled to the console, the treatment device having a treatment element operable to reach temperatures sufficient to ablate tissue.

10. The system of claim 9, wherein the treatment element is in communication with the at least one of the energy generator and the cryogenic fluid source in communication with the treatment element.

11. The system of claim 9, wherein the microcontroller is programmed to automatically adjust at least one of the application of ablation energy from the energy generator to the treatment element and the circulation of cryogenic fluid from the cryogenic fluid source through the treatment element in response to at least one alert criterion being met, the at least one criterion being established by the microcontroller.

12. The system of claim 11, wherein the at least one alert criterion is selected from the group consisting of:

the treatment amplitude value is less than the threshold amplitude value; and

the treatment amplitude over time value is less than the threshold amplitude over time value.

13. The system of claim 1, wherein the microcontroller is programmable to automatically turn off the foot switch in response to at least one alert criterion being met, the at least one alert criterion being established by the microcontroller.

14. The system of claim 13, wherein the at least one alert criterion is selected from the group consisting of:

the treatment amplitude value is less than the threshold amplitude value; and

the treatment amplitude over time value is less than the threshold amplitude over time value.

15. A system for monitoring phrenic nerve function in response to stimulation energy, the system comprising:

a stimulation energy source;

a pacing device including at least one pacing electrode in communication with the stimulation energy source, the at least one pacing electrode being operable to transmit stimulation energy to the phrenic nerve through a target tissue structure proximate the phrenic nerve;

a treatment system including;

a console having a foot switch and at least one of an energy generator and a cryogenic fluid source;

a treatment device coupled to the console, the treatment device having a treatment element operable to reach temperatures sufficient to ablate tissue, the at least one of the energy generator and the cryogenic fluid source being in communication with the treatment element;

a plurality of assessment electrodes operable to detect diaphragmatic compound motor action potential (CMAP) signals in response to the stimulation energy; and

a processing device including a microcontroller that is in direct communication with the foot switch, the microcontroller programmed to make comparisons during a delivery of ablation energy and to determine if phrenic nerve function is impaired based on the comparisons, the comparisons being based on the CMAP signals detected by the plurality of assessment electrodes before and during the delivery of ablation energy to a cardiac tissue, the comparisons being;

a comparison between a baseline amplitude value for the diaphragmatic CMAP signals detected before the delivery of ablation energy and a real-time treatment amplitude value for the diaphragmatic CMAP signals detected during the delivery of ablation energy to the cardiac tissue;

a comparison between a real-time treatment amplitude value for the diaphragmatic CMAP signals detected during the delivery of ablation energy to the cardiac tissue and a threshold amplitude value for the diaphragmatic CMAP signals determined before the delivery of ablation energy;

a comparison between a baseline amplitude over time value for the diaphragmatic CMAP signals detected before the delivery of ablation energy and a real-time treatment amplitude over time value for the diaphragmatic CMAP signals detected during the delivery of ablation energy to the cardiac tissue; and

a comparison between a real-time treatment amplitude over time value for the diaphragmatic CMAP signals detected during the delivery of ablation energy to the cardiac tissue and a threshold amplitude over time value for the diaphragmatic CMAP signals determined before the delivery of ablation energy,

the microcontroller being further programmed to automatically operate the foot switch to at least one of adjust an amount of energy delivered from the energy generator and adjust a flow of cryogenic fluid from the cryogenic fluid source when the microcontroller determines that phrenic nerve function is impaired.

16. The system of claim 15, wherein the microcontroller is further programmed to average the diaphragmatic CMAP signals.

17. A method for monitoring patient phrenic nerve function in response to the transmission of a stimulation energy to the phrenic nerve, the method consisting of:

applying a stimulation energy from a pacing device to the phrenic nerve;

recording diaphragmatic compound motor action potential (CMAP) signals using a plurality of assessment electrodes attached to the patient proximate the xiphoid process and the right costal margin of the patient'"'"'s ribcage;

transmitting the CMAP signals from the plurality of assessment electrodes to a processing device having a microcontroller, the microcontroller being programmed to;

average the CMAP signals;

determine, before performance of an ablation procedure a baseline CMAP signal amplitude and a baseline CMAP signal amplitude over time; and

receive from a user before the ablation procedure a threshold CMAP signal amplitude value and a threshold CMAP signal amplitude over time value;

performing the ablation procedure, the performing the ablation procedure including the processing device controlling a circulation of cryogenic fluid through a treatment element of an ablation device to remove an amount of heat from an area of tissue within the patient'"'"'s heart;

receiving with the microcontroller during the ablation procedure real-time CMAP signal amplitudes and CMAP signal amplitudes over time from the plurality of assessment electrodes;

during performance of the ablation procedure, making comparisons with the microcontroller, the microcontroller being programmed to;

compare the baseline CMAP signal amplitude and the real-time CMAP signal amplitudes received during the ablation procedure;

compare the baseline CMAP signal amplitude over time and the real-time CMAP signal amplitudes over time received during the ablation procedure;

compare the real-time CMAP signal amplitudes received during the ablation procedure and the predetermined threshold CMAP signal amplitude;

compare the real-time CMAP signal amplitudes over time received during the ablation procedure and the predetermined threshold CMAP signal amplitudes over time; and

determine if phrenic nerve function is impaired based on the comparisons; and

automatically operating a foot switch with the processing device to adjust a flow of cryogenic fluid through the treatment element of the ablation device to modify an amount of heat removed from the area of tissue by the ablation device during performance of the ablation procedure when the microcontroller determines that phrenic nerve function is impaired, the processing device being in direct communication with the foot switch.