CN112826490A - IONM electrode contact effectiveness measuring device and measuring method - Google Patents
IONM electrode contact effectiveness measuring device and measuring method Download PDFInfo
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- CN112826490A CN112826490A CN202110007454.1A CN202110007454A CN112826490A CN 112826490 A CN112826490 A CN 112826490A CN 202110007454 A CN202110007454 A CN 202110007454A CN 112826490 A CN112826490 A CN 112826490A
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- 238000000034 method Methods 0.000 title claims abstract description 15
- 230000000638 stimulation Effects 0.000 claims abstract description 41
- 238000004364 calculation method Methods 0.000 claims abstract description 10
- 238000001514 detection method Methods 0.000 claims abstract description 10
- 230000003321 amplification Effects 0.000 claims description 13
- 238000003199 nucleic acid amplification method Methods 0.000 claims description 13
- 239000000523 sample Substances 0.000 claims description 11
- 238000005259 measurement Methods 0.000 claims description 10
- 230000007274 generation of a signal involved in cell-cell signaling Effects 0.000 claims description 6
- 238000003908 quality control method Methods 0.000 claims description 3
- 230000010354 integration Effects 0.000 abstract 1
- 230000035945 sensitivity Effects 0.000 abstract 1
- 238000010586 diagram Methods 0.000 description 4
- 238000006243 chemical reaction Methods 0.000 description 3
- 238000012544 monitoring process Methods 0.000 description 3
- 210000005036 nerve Anatomy 0.000 description 3
- 210000001685 thyroid gland Anatomy 0.000 description 3
- 210000000653 nervous system Anatomy 0.000 description 2
- 238000005070 sampling Methods 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 210000001260 vocal cord Anatomy 0.000 description 2
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000005468 ion implantation Methods 0.000 description 1
- 238000002955 isolation Methods 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000005728 strengthening Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 210000003437 trachea Anatomy 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
- A61B5/053—Measuring electrical impedance or conductance of a portion of the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6886—Monitoring or controlling distance between sensor and tissue
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Abstract
The invention discloses an IONM electrode contact effectiveness measuring device, which comprises a stimulation signal generating unit, an object to be measured, a data acquisition unit and a numerical value calculating unit, wherein the stimulation signal generating unit is used for generating a stimulation signal; the object to be tested is respectively connected with the stimulation signal generating unit and the data acquisition unit, and the numerical value calculation unit is connected with the data acquisition unit; the numerical calculation unit obtains an impedance value by adopting a fitting algorithm. The invention also discloses a detection method adopting the device for measuring the contact effectiveness of the IONM electrode. The method has the advantages of quickly and effectively obtaining the impedance value of the detection electrode contacting the human tissue, judging the effectiveness of the IONM electrode contacting the human tissue, along with simple operation, high sensitivity and convenient integration.
Description
Technical Field
The present invention relates to a measuring apparatus and a measuring method, and more particularly, to a measuring apparatus and a measuring method for an ion implantation nm electrode contact validity.
Background
The incidence of nervous system complications during the operation is gradually increased, and the disease death rate and disability rate are higher, and the life quality of a patient is seriously influenced, so that the strengthening of intraoperative nerve monitoring (IONM) and the reduction of the incidence of the nervous system complications have great significance.
Effective, stable and reliable intraoperative nerve monitoring requires that positive and negative detection electrodes used for monitoring signals effectively contact human tissues. In the initial stage of IONM, whether the detecting electrode is effectively contacted with human tissue is visually observed, for example, when thyroid operation is performed, a tracheal cannula is inserted into a trachea by using laryngoscope observation, and the detecting electrode is inserted into vocal cord tissue. The problem that the error is large and inconvenient exists in the judgment of the contact validity of the IONM electrode through visual observation.
Clinical research shows that after the detection electrode is inserted into human tissue and organs, different human bodies and instruments mounted on the human bodies have relatively large clutter interference, especially around 50 Hz. And the stimulation signal voltage directly contacting human tissue is small, often less than 5mV, which increases the difficulty for solving the detection electrode contact effectiveness measurement by using the electrical principle.
Disclosure of Invention
The purpose of the invention is as follows: the invention aims to solve the defects in the prior art, provides a device and a method for measuring the contact validity of an IONM electrode, and solves the problems of large error and inconvenience in measurement of the contact validity of the IONM electrode.
The technical scheme is as follows: the device for measuring the contact effectiveness of the IONM electrode comprises a stimulation signal generation unit, an object to be measured, a data acquisition unit and a numerical value calculation unit; the object to be measured is respectively connected with the stimulation signal generating unit and the data acquisition unit, and the numerical value calculating unit is connected with the data acquisition unit.
The object to be detected is connected with the stimulation signal generation unit through the detection electrode.
The stimulation signal generation unit comprises a sine stimulation generator and a stimulation signal amplifier, the output of the sine stimulation generator is connected with the input of the stimulation signal amplifier, and sine current signals sent by the stimulation signal generation unit pass through an object to be tested and then output sine voltage signals with the frequency of 150Hz-250Hz and the amplitude of 100 mu V-5 mV.
The object to be detected is human tissue or a quality control resistor.
The data acquisition unit comprises a probe electrode, an analog amplification circuit, an analog-to-digital converter and a digital filter; the probe electrode is connected with the input of the analog amplification circuit, the output of the analog amplification circuit is connected with the input of the analog-to-digital converter, and the output of the analog-to-digital converter is connected with the input of the digital filter.
The digital filter is an IIR digital band-pass filter with the passband frequency of 80 Hz-400 Hz.
The numerical calculation unit obtains an impedance value by adopting a fitting algorithm.
A measuring method of an IONM electrode contact effectiveness measuring device comprises the following steps:
(1) obtaining a fitting formula of the impedance value and the amplitude of the acquired sinusoidal signal;
(2) obtaining an impedance value of the object to be measured according to a fitting formula;
(3) and judging whether the object to be detected can enter an IONM stage or not according to the obtained impedance value.
The step (2) comprises the following steps:
(21) the probe electrode contacts the object to be detected;
(22) the stimulation signal generating unit outputs a stimulation current signal to flow through the object to be tested;
(23) the data acquisition unit amplifies sinusoidal voltage signals loaded at two ends of an object to be detected, converts the sinusoidal voltage signals into digital quantity by the analog-to-digital converter, and outputs the digital quantity through the digital filter;
(24) and the data calculation unit calculates to obtain the amplitude of the output signal of the digital filter and obtains the impedance value of the object to be measured according to a fitting formula.
Has the advantages that: compared with the prior art, the method has the obvious advantages that the contact effectiveness of the IONM detection electrode is judged by measuring the impedance value of the object to be detected, the device is simple to operate, low in cost and convenient to transplant.
Drawings
FIG. 1 is a schematic diagram of the apparatus of the present invention;
FIG. 2 is a circuit diagram of the apparatus of the present invention;
FIG. 3 is a graph of a linear fit of the impedance value to the amplitude of a sinusoidal signal according to the present invention.
Detailed Description
The technical scheme of the invention is further explained by combining the attached drawings.
The schematic diagram of the invention is shown in fig. 1, and the measuring device of the invention comprises a stimulation signal generating unit, an object to be measured, a data acquisition unit and a numerical value calculating unit; the object to be measured is respectively connected with the stimulation signal generating unit and the data acquisition unit, and the numerical value calculating unit is connected with the data acquisition unit. The object to be detected is connected with the stimulation signal generation unit through the detection electrode. The object to be measured is human tissue or a quality control resistor. The numerical calculation unit obtains the impedance value of the object to be measured by adopting a fitting algorithm.
The stimulation signal generating unit comprises a sine stimulation generator and a stimulation signal amplifier, the output of the sine stimulation generator is connected with the input of the stimulation signal amplifier, and sine current signals sent by the stimulation signal generating unit pass through an object to be tested and then output sine voltage signals with the frequency of 150Hz-250Hz and the amplitude of 100 MuV-5 mV.
The data acquisition system unit comprises a probe electrode, an analog amplification circuit, an analog-to-digital converter and a digital filter; the probe electrode is connected with an analog amplification circuit, the output of the analog amplification circuit is connected with an analog-to-digital converter, and the output of the analog-to-digital converter is connected with a digital filter; the analog amplification circuit amplifies the voltage signal collected by the probe electrode, then transmits the voltage signal to the analog-to-digital converter to be converted into a digital signal, and obtains the amplitude of the digital sinusoidal signal through the digital filter. The digital filter is an IIR digital band-pass filter with the passband frequency of 80 Hz-400 Hz. The data acquisition unit adopts a low-noise isolation power supply and a low-noise differential amplifier.
In this embodiment, a circuit diagram of the present invention is shown in fig. 2. The stimulation signal generating unit circuit consists of a DAC digital-to-analog conversion circuit and a voltage follower circuit designed by an operational amplifier, and generates sinusoidal current signals with adjustable frequency and amplitude. After the sinusoidal current signal passes through human tissues of an object to be detected, a sinusoidal voltage signal with the frequency of 150Hz-250Hz and the amplitude of 100 MuV-5 mV is generated and sent to a data acquisition unit. When the thyroid surgery is performed on a human body, one end of the stimulation signal is directly inserted into vocal cord tissues through the detection electrode, and the other end of the stimulation signal is in grounding contact with the skin of the human body.
The analog amplification circuit in the data acquisition unit adopts an instrument amplification circuit, and the instrument amplifier has the excellent characteristics of low noise, high gain controllability and the like. An instrument amplifier composed of an AD620 chip is adopted to amplify the original electrode differential signals passing through human tissues and output the signals to an analog-to-digital conversion circuit. The analog-to-digital conversion circuit adopts an ADC chip, in order to improve the effective accuracy of calculation, the AD7124 is adopted, the sampling accuracy is 24 bits, the maximum supporting 19200SPS sampling rate is far greater than the maximum passband frequency of 400Hz in a full-power mode, and programmable gain amplification can be carried out according to actual needs, so that the requirements of the system are completely met.
The CPU controller and the auxiliary circuit acquire signals acquired and amplified by the ADC chip, other noise signals are filtered through an IIR digital filter algorithm realized by software, pure 200Hz sinusoidal signals are left, the maximum difference value of the wave crest and the wave trough of a single sine is identified for the sinusoidal signals and is brought into a fitting formula, finally an electrical impedance value is calculated, and whether the electrode effectively contacts human tissues or not can enter an IONM stage is judged according to the acquired impedance value.
The invention relates to a measuring method of an IONM electrode contact effectiveness measuring device, which comprises the following steps:
the method comprises the following steps:
(1) obtaining a fitting formula of the impedance value and the amplitude of the acquired sinusoidal signal;
(2) obtaining an impedance value of the object to be measured according to a fitting formula;
(21) the probe electrode contacts the object to be detected;
(22) the stimulation signal generating unit outputs a stimulation current signal to flow through the object to be tested;
(23) the data acquisition unit amplifies sinusoidal voltage signals loaded at two ends of an object to be detected, converts the sinusoidal voltage signals into digital quantity by the analog-to-digital converter, and outputs the digital quantity through the digital filter;
(24) and the data calculation unit calculates to obtain the amplitude of the output signal of the digital filter and obtains the impedance value of the object to be measured according to a fitting formula.
(3) And judging whether the object to be detected can enter an IONM stage or not according to the obtained impedance value.
In this example, 4 sets of impedance values and amplitudes of sinusoidal signals were obtained by experiments, as shown in the following table.
| Amplitude value | Resistance (omega) |
| 461380 | 750 |
| 461640 | 1700 |
| 461838 | 2540 |
| 462015 | 3120 |
As can be seen from fig. 3, according to the 4 sets of data, the linear fitting equation of the impedance value | Z | and the amplitude X of the sinusoidal signal obtained by the least square method is:
|Z|＝3.7827*X-1.744*106
the biological impedance value which is stable and in a reasonable resistance value range can effectively judge whether the metal probe effectively contacts the human body. The evaluation criteria for touch or not were: the impedance value of a single electrode is less than 5k omega, good contact is achieved, abnormal contact is achieved when the impedance value is more than 5k omega, the electrode falls off or other reasons.
Data obtained by measuring the nerve test items in a certain thyroid surgery by using the measuring device of the present invention are shown in the following table. Wherein: the impedance values of the left electrode +, the left electrode and the right electrode are all 1.2k omega, and the left electrode, the left electrode and the right electrode are effective contacts; the right electrode-impedance value was 10.9k Ω, which was not in contact with the upper body tissue, and was caused by electrode detachment.
| Item | Amplitude value | Impedance value (k omega) |
| Left side electrode + | 461372 | 1.2 |
| Left side electrode- | 461358 | 1.2 |
| Right side electrode + | 461395 | 1.3 |
| Right side electrode- | 464075 | 10.9 |
Claims (9)
1. An ion electrode contact effectiveness measurement device, characterized by: the device comprises a stimulation signal generating unit, an object to be detected, a data acquisition unit and a numerical value calculating unit; the object to be measured is respectively connected with the stimulation signal generating unit and the data acquisition unit, and the numerical value calculating unit is connected with the data acquisition unit.
2. The IONM electrode contact effectiveness measurement device of claim 1, wherein: the object to be detected is connected with the stimulation signal generation unit through the detection electrode.
3. The IONM electrode contact effectiveness measurement device of claim 1, wherein: the stimulation signal generating unit comprises a sine stimulation generator and a stimulation signal amplifier, and the output of the sine stimulation generator is connected with the input of the stimulation signal amplifier; after the sinusoidal current signal sent by the stimulation signal generating unit passes through the object to be tested, a sinusoidal voltage signal with the frequency of 150Hz-250Hz and the amplitude of 100 muV-5 mV is output.
4. The IONM electrode contact effectiveness measurement device of claim 1, wherein: the object to be detected is human tissue or a quality control resistor.
5. The IONM electrode contact effectiveness measurement device of claim 1, wherein: the data acquisition unit comprises a probe electrode, an analog amplification circuit, an analog-to-digital converter and a digital filter; the probe electrode is connected with the input of the analog amplification circuit, the output of the analog amplification circuit is connected with the input of the analog-to-digital converter, and the output of the analog-to-digital converter is connected with the input of the digital filter.
6. An IONM electrode contact effectiveness measurement apparatus according to claim 5, characterized in that: the digital filter is an IIR digital band-pass filter with the passband frequency of 80 Hz-400 Hz.
7. The IONM electrode contact effectiveness measurement device of claim 1, wherein: the numerical calculation unit obtains an impedance value by adopting a fitting algorithm.
8. A measuring method of an IONM electrode contact effectiveness measuring device is characterized in that: the method comprises the following steps:
(1) obtaining a fitting formula of the impedance value and the amplitude of the acquired sinusoidal signal;
(2) obtaining an impedance value of the object to be measured according to a fitting formula;
(3) and judging whether the object to be detected can enter an IONM stage or not according to the obtained impedance value.
9. The method of claim 8, wherein the method of measuring the effectiveness of the IONM electrode contact measurement device comprises: the step (2) comprises the following steps:
(21) the probe electrode contacts the object to be detected;
(22) the stimulation signal generating unit outputs a stimulation current signal to flow through the object to be tested;
(23) the data acquisition unit amplifies sinusoidal voltage signals loaded at two ends of an object to be detected, converts the sinusoidal voltage signals into digital quantity by the analog-to-digital converter, and outputs the digital quantity through the digital filter;
(24) and the data calculation unit calculates to obtain the amplitude of the output signal of the digital filter and obtains the impedance value of the object to be measured according to a fitting formula.
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| CN110338793A (en) * | 2019-07-05 | 2019-10-18 | 北京师范大学 | Personalized human body impedance detection technology through cranium galvanic current stimulation |
| CN110772232A (en) * | 2019-12-31 | 2020-02-11 | 成都怡康科技有限公司 | Electrode falling detection circuit and detection method |
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2021
- 2021-01-05 CN CN202110007454.1A patent/CN112826490A/en active Pending
Patent Citations (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103142225A (en) * | 2013-03-27 | 2013-06-12 | 秦皇岛市康泰医学系统有限公司 | Electroencephalograph for determining contact status between electrode and scalp and method for determining same |
| US9174052B1 (en) * | 2014-07-10 | 2015-11-03 | Pacesetter, Inc. | Methods and systems for controlling stimulation in paddle lead based on local impedances |
| CN106139392A (en) * | 2016-01-15 | 2016-11-23 | 深圳市科瑞康实业有限公司 | Neuromuscular electric stimulation therapy instrument and electrode impedance measurement apparatus and method thereof |
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Application publication date: 20210525 |