Method and device for quantification of neuromuscular stimulations due to RF-currents

Patent metadata

Field	Value
Publication number	US-11052257-B2
Application number	US-202016883489-A
Country	US
Kind code	B2
Filing date	May 26, 2020
Priority date	May 27, 2019
Publication date	Jul 6, 2021
Grant date	Jul 6, 2021

Abstract

A two-part NMS-test bench is provided with which instruments, generator voltages, and surgery modes can be evaluated with regard to neuromuscular stimulations. By separating the NMS-test bench in a first part for application of the instrument and in the second part for evaluation of the physiological effect on nerves, a measurement free of artifacts is possible. The spatial and timely separation of the RF-application from the recording of the compound action potentials makes RF-disturbances ineffective. The electrical signals gained in the instrument test chamber can be pre-processed. The recorded electrical signals emitted from the instrument can be evaluated at the nerve model an arbitrary number of times. The variance involved with the recording of compound action potentials during direct use of the instrument can thus be minimized. The separated test of the signals at the nerve model avoids thermal damage of a prepared nerve and falsification of measurement results.

First claim

The invention claimed is:

1. A method for quantifying neuromuscular stimulations external from a living organism, the method comprising the following steps:
applying a radio frequency voltage to an instrument ( 16 ) located in an instrument test chamber ( 12 ) and positioning the instrument in a defined manner,
recording an electrical signal (S) in the instrument test chamber ( 12 ) via at least one electrode ( 22 ),
determining a stimulation signal (A) from the recorded electrical signal (S), and
stimulating a nerve model ( 30 ) with the stimulation signal and detecting compound action potentials (CAPs) output from the nerve model ( 30 ).

2. The method according to claim 1 , further comprising placing a section of a prepared nerve ( 34 ) for use as the nerve model ( 30 ) in a nerve test chamber ( 33 ) comprising at least one stimulation electrode pair ( 39 , 40 ) and at least one diverting electrode pair ( 41 , 42 ), such that the prepared nerve ( 34 ) contacts the at least one stimulation electrode pair ( 39 , 40 ) as well as the at least one diverting electrode pair ( 41 , 42 ), and applying the stimulation signal (A) to the stimulation electrode ( 39 , 40 ) and detecting a signal arriving at the diverting electrodes ( 41 , 42 ) as compound action potentials (CAPs).

3. The method according to claim 1 , further comprising storing the recorded electrical signal (S).

4. The method according to claim 1 , further comprising processing the recorded electrical signal (S) for determination of the stimulation signal (A).

5. The method according to claim 4 , further comprising low pass filtering the recorded electrical signal (S) for determination of the stimulation signal (A).

6. The method according to claim 1 , further comprising buffering the stimulation signal (A).

7. The method according to claim 6 , further comprising standardizing the stimulation signal (A) by referencing it with a reference stimulation voltage.

8. The method according to claim 7 , wherein standardizing the stimulation signal includes applying a reference stimulation signal to the stimulation electrode ( 39 , 40 ) and determining first the compound action potential (CAP) and subsequently increasing or decreasing the reference stimulation signal until the resulting compound action potential (CAP) is within predetermined limits.

9. The method according to claim 8 , further comprising amplifying or attenuating the stimulation signal (A) with an amplification factor determined by a quotient of an amplitude of a stimulation signal providing a predefined fraction (CAP 80 ) of the compound action potential (CAP) and an initial amplitude of the reference stimulation signal.

10. The method according to claim 1 , further comprising determining a stimulus artifact (ART) by applying the stimulation signal (A) to a non-functional nerve inserted in the nerve test chamber ( 33 ).

11. The method according to claim 10 , further comprising determining a difference signal by subtracting the stimulus artifact (ART) of the non-functional nerve from the compound action potentials (CAPs) of a functional nerve and evaluating at least one of the instrument ( 16 ), the radio frequency voltage, and the positioning of the instrument ( 16 ) in view of a potential for neuromuscular stimulations based on the difference signal.

12. A device for quantification of neuromuscular stimulations external from a living organism, the device comprising:
an instrument test chamber ( 12 ) that comprises a first compartment ( 13 ), a second compartment ( 14 ), and a wall ( 15 ) separating the first and second compartments, wherein each of the first and second compartments are configured to be at least partly filled with a liquid,
diverting electrodes ( 22 , 23 , 24 , 25 ) positioned in the first compartment ( 13 ); and wherein the second compartment ( 14 ) is configured to receive a device to be tested,
a pre-processing unit ( 36 ) to which signals (S) output from the diverting electrodes ( 22 , 23 , 24 , 25 ) are supplied, wherein a signal generator ( 37 ) is connected to the pre-processing unit ( 36 ), and a nerve test chamber ( 33 ) configured to receive a prepared nerve ( 34 ), wherein the signal generator ( 37 ) is connected to the nerve test chamber ( 33 ).

13. The device according to claim 12 , wherein the wall ( 15 ) is a current conducting membrane made of prepared biological material.

14. The device according to claim 12 , wherein the nerve test chamber ( 33 ) comprises two stimulation electrodes ( 39 , 40 ) and at least two diverting electrodes ( 41 , 42 ).

15. The device according to claim 14 , wherein the at least two diverting electrodes ( 41 , 42 ) are configured as sticks arranged in a common plane parallel to each other.

Assignees

• Erbe Elektromedizin

Inventors

• Enderle Markus
• Biber Ulrich
• Jurjut Ovidiu

Classifications

• A61B18/1233 Primary

  with circuits for assuring patient safety · CPC title

• A61N1/36192

  Amplitude modulation · CPC title

• A61B2018/126

  bipolar · CPC title

• A61B5/24

  Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof · CPC title

• A61N1/3787

  from an external energy source · CPC title