CN115979335A

CN115979335A - Special equipment and method for detecting magnetic field and temperature of transcranial magnetic stimulation therapeutic apparatus

Info

Publication number: CN115979335A
Application number: CN202211535585.8A
Authority: CN
Inventors: 李成伟; 洪宝玉; 刘文丽; 陆舒洁; 张璞; 李姣; 张鹏; 孙劼
Original assignee: National Institute of Metrology
Current assignee: National Institute of Metrology
Priority date: 2022-11-30
Filing date: 2022-11-30
Publication date: 2023-04-18

Abstract

The invention relates to a special device and a method for detecting magnetic field and temperature of a transcranial magnetic stimulation therapeutic apparatus, wherein the special device comprises: the bionic head model comprises a bionic head model body, a special bracket, a magnetic field measuring probe, a temperature measuring module, a device host, a control computer and a data line. The bionic head die body is arranged at the bottom of the special support, the magnetic field measuring probe is arranged at the top of the special support, and the device host is respectively connected with the magnetic field measuring probe, the temperature measuring module and the control computer through data wires. Designing a bionic head die body equivalent to the head electromagnetic characteristic, and measuring the magnetic field in the space where the die body is located and the temperature of the surface of the coil; and calculating and analyzing the magnetic field measurement result to obtain the measurement results of the maximum magnetic induction intensity, the spatial magnetic field distribution, the output frequency, the stimulation pulse width and the coil surface temperature. The method is suitable for the research and development of the transcranial magnetic stimulation therapeutic apparatus and the detection and calibration of the core parameters in clinical use, and ensures the use safety and effectiveness of the transcranial magnetic stimulation therapeutic apparatus.

Description

Special equipment and method for detecting magnetic field and temperature of transcranial magnetic stimulation therapeutic apparatus

Technical Field

The invention relates to special equipment and a method for detecting magnetic field and temperature in the field of medical detectors, in particular to special equipment and a method for detecting the magnetic field and the temperature of a transcranial magnetic stimulation therapeutic apparatus.

Background

The discovery and experimental verification of the phenomenon of magnetic flashing (Magnetophosphoprene) at the end of the nineteenth century opened the beginning of the regulation of human neural activity by magnetic fields. Thereafter, many research teams have conducted stimulation experiments on tissues such as muscles, peripheral nerves and cerebral cortex of the human body by using magnetic fields, and have accumulated abundant experimental data. In 1985, the first Transcranial Magnetic Stimulation (TMS) treatment instrument was developed successfully by Barker et al, royal Harbourshire hospital, university of Sheffield, UK. The equipment stimulates the nerve cells in the target area by using a pulsed magnetic field to generate an induced electric field, so that the membrane potential of the nerve cells is changed, and the activity of the nerve cells is regulated. The TMS therapeutic apparatus has the advantages of no wound, no damage, simple operation and the like, and is widely applied to the fields of diagnosis and treatment of neurological diseases, treatment of mental diseases, rehabilitation physiotherapy, brain function detection and the like. Especially has obvious curative effect on TMS treatment aiming at mental diseases such as drug-refractory depression and the like.

With the increase of working pressure and the acceleration of life rhythm, the number of patients suffering from various mental diseases is continuously increased, only one item of depression is needed, and the number of adult patients exceeds 6000 million. TMS therapy apparatuses are rapidly spreading as psychiatric treatment devices proven to be effective in more than two hospitals. The TMS therapeutic apparatus is divided into a single-pulse transcranial magnetic stimulation therapeutic apparatus, a paired-pulse transcranial magnetic stimulation therapeutic apparatus, a repeated transcranial stimulation therapeutic apparatus and a burst-pulse transcranial magnetic stimulation therapeutic apparatus according to different stimulation sequence design modes. Among them, the repeated Transcranial Magnetic Stimulation (rTMS) therapeutic apparatus has the widest clinical application range and the highest popularity, and thus becomes a key focus of the medical instrument monitoring and control organization.

In order to standardize the production and use of TMS therapeutic instruments, different organizations at home and abroad issue a plurality of technical standards aiming at the equipment. The European Union promulgated a new edition of Medical Device Regulation (MDR; regulation (EU) 2017/745) in 2017, in which TMS devices are classified as class B Medical devices and manufacturers are required to register as required; the Food and Drug Administration (FDA) divides TMS devices into two types of medical devices, and requires technical data of parameters such as Magnetic field characteristics (waveform, timing, pulse width, intensity, etc.), output waveform, magnetic field spatial distribution, magnetic field gradient, etc. when the rTMS device is registered in the "Class II Special Controls Guidance decision (rTMS) Systems" issued by the FDA; in China, only the medical industry standard YY/T0994-2015 magnetic stimulation equipment for TMS therapeutic instrument registration inspection is available, and the standard only specifies the accuracy of parameters such as magnetic induction intensity, output frequency, stimulation pulse width and timing, but does not specify a specific detection method.

By combining the domestic and foreign standards, the domestic standard pays more attention to the quality control of equipment production and registration inspection links, and the clinical use safety and stimulation accuracy of TMS therapeutic instruments, particularly the rTMS therapeutic instruments, lack available detection equipment and special methods. When the TMS therapeutic apparatus is used clinically, the TMS therapeutic apparatus generates a strong magnetic field (more than 1T) by using extremely high current, and the strong magnetic field directly acts on the human brain to generate an induction electric field. Transient cerebral dysfunction such as epilepsy may be induced by excessive stimulation intensity; and the stimulation intensity is too low, the treatment effect cannot be achieved, and the ineffective electromagnetic exposure of the patient is increased. Therefore, the stimulation safety and accuracy of the TMS therapeutic apparatus in the clinical use link need to be detected and evaluated, so that the TMS therapy can be ensured to be safe and reliable.

According to the Faraday's law of electromagnetic induction, a changing current generates an alternating magnetic field that induces an electric field inside a substance. Therefore, when the TMS therapeutic apparatus is used, a magnetic field and an electric field are generated at a target area of a human brain target in sequence. The characteristic parameters of the electric field are closely related to the characteristic parameters of the brain tissue, the electric fields induced by different individuals after TMS are different, and the measurement of the electric field intensity in the tissue needs to be received by a special antenna, so that the cost is high and the measurement is difficult to realize. The characteristic parameters of the alternating magnetic field generated by the TMS therapeutic apparatus are mainly determined by the performance of the equipment, the magnetic field transmission process is only influenced by the structure and the propagation distance of an object, the magnetic field intensity measurement technology is mature, and the realization cost is low. Therefore, by combining the existing domestic and foreign standards and published academic papers, the evaluation of the clinical use safety and stimulation accuracy of the TMS therapeutic apparatus is mainly developed around the generated magnetic field characteristic parameters and the change of the coil surface temperature during magnetic stimulation. At present, the main detection method for the magnetic field generated by the TMS therapeutic apparatus is to establish a numerical model of a stimulation coil of the TMS therapeutic apparatus by using an analog simulation technology, perform current parameter assignment, and then obtain the spatial distribution of the magnetic field generated by the stimulation coil by using methods such as finite element analysis and the like; and measuring by using a teslameter to obtain a magnetic induction intensity numerical value of the surface of the stimulating coil, comparing and verifying with an analog simulation result, and verifying the accuracy of the analog simulation result. The magnetic field detection method mainly adopts analog simulation and assists actual measurement verification, and has two obvious defects.

First, the necessary detection motifs are missing. The magnetic field generated by the TMS therapeutic apparatus directly acts on the human brain, although theoretically, the magnetic field does not generate loss when passing through different substances in the space transmission process, in order to ensure that the magnetic field is as close to the actual stimulation result as possible in simulation, a bionic head model numerical model is established at the same time, and the electromagnetic field distribution in the model is acquired; in addition, the detection method mainly uses the measured data and assists the simulation, and evaluates the characteristic parameters of the magnetic field generated by the TMS therapeutic apparatus by researching and developing a bionic head die body with the equivalence of the head of the human body and actually measuring the magnetic field intensity of the typical position in the simulated head die body. The equivalence of the bionic head mold body mainly inspects structural equivalence and electromagnetic characteristic parameter equivalence, but no mature product suitable for TMS therapeutic instrument detection exists in the current commercial mold body.

Second, there is a lack of available magnetic field measurement probes. The TMS therapeutic apparatus generates a damping current in the stimulating coil, the pulse width of the damping current is about 400 mus, and the frequency of an alternating magnetic field excited by the damping current is about 2.8kHz. According to the Nyquist sampling theorem, the sampling frequency of the magnetic field measuring probe is at least 6kHz to ensure that the magnetic field signals acquired are not distorted. Meanwhile, according to the simulation result, the instantaneous value of the alternating magnetic field intensity generated by the surfaces of the stimulation coils of different TMS therapeutic instruments can reach 4T, in order to measure the magnetic field intensity on the surfaces of the coils, the measuring range of the magnetic field measuring probe at least needs to cover 0-4T, and three-dimensional orthogonal magnetic field intensity data acquisition and analysis can be realized. At present, almost no commercial Tesla meters capable of simultaneously meeting triaxial measurement, 6kHz sampling frequency and 0-4T measurement range exist, limited products need to be customized and developed according to detection requirements, and cost is high.

In view of the above-mentioned drawbacks of the prior art, the present inventors have made extensive studies and design, and have conducted trial and improvement repeatedly, thereby finally creating the present invention having practical value.

Disclosure of Invention

The invention mainly aims to provide novel special equipment and a novel special method for detecting magnetic field and temperature of a transcranial magnetic stimulation therapeutic apparatus, and aims to solve the technical problems of researching and developing a bionic head model with human head equivalence, researching and developing a high-sampling-frequency and wide-range triaxial magnetic field measuring probe, realizing detection of characteristic parameters such as maximum magnetic induction intensity, spatial magnetic field distribution, output frequency, stimulation pulse width, coil surface temperature and the like of an alternating magnetic field generated by a TMS therapeutic apparatus, improving and ensuring accuracy and feasibility degree of a detection result through uncertainty evaluation of the detection result, and ensuring safety and effectiveness of the TMS therapeutic apparatus.

The purpose of the invention and the technical problem to be solved are realized by adopting the following technical scheme. The special equipment for detecting the magnetic field and the temperature of the transcranial magnetic stimulation therapeutic apparatus comprises a bionic head die body, a special bracket, a magnetic field measuring probe, a temperature measuring module, a device host, a control computer, a data line and measuring software.

The bionic head die body is composed of a thin spherical shell located on the upper layer and a thick spherical shell located on the lower layer, the thin spherical shell and the thick spherical shell are of an integrated structure which is made of cylindrical acrylic base materials through cutting, the bionic head die body is arranged on the base, the magnetic field measuring probe is arranged at the top of the sliding block of the special support, the device host is connected with the magnetic field measuring probe, the temperature measuring module and the control computer through data lines, and the measuring software is installed in the control computer.

Further, the thin spherical shell is composed of a thin spherical shell main body and a thin spherical shell edge, wherein the thin spherical shell main body is a hemisphere with the wall thickness not more than 3mm and the inner diameter of 140-150 mm, a first thin spherical shell liquid guide hole, a second thin spherical shell liquid guide hole, a third thin spherical shell liquid guide hole and a fourth thin spherical shell liquid guide hole are symmetrically etched at the positions of 0 degrees, 90 degrees, 180 degrees and 270 degrees on the lower edge of the thin spherical shell edge respectively, and an annular groove is etched at the position, close to the thin spherical shell main body, of the lower edge of the thin spherical shell edge; the thick spherical shell is composed of a thick spherical shell main body and a thick spherical shell edge, wherein the thick spherical shell main body is a hemispherical shell with the wall thickness not exceeding 12mm and the inner diameter of 150-165 mm, a first annular bulge is arranged above the thick spherical shell edge and along the inner edge of the thick spherical shell main body, a first thick spherical shell liquid guide hole, a second thick spherical shell liquid guide hole, a third thick spherical shell liquid guide hole and a fourth thick spherical shell liquid guide hole are symmetrically etched at the positions of 0 degree, 90 degree, 180 degree and 270 degree of the first annular bulge respectively, a positioning line is etched at the central positions of the side surface of the thick spherical shell edge, which are opposite to the first thick spherical shell liquid guide hole, the second thick spherical shell liquid guide hole, the third thick spherical shell liquid guide hole and the fourth thick spherical shell liquid guide hole respectively, the first annular bulge is embedded into an annular groove, the first thick spherical shell liquid guide hole, the second thick spherical shell liquid guide hole, the third thick spherical shell liquid guide hole and the fourth thick spherical shell liquid guide hole are the same as the first thick spherical shell liquid guide hole, the second thick spherical shell liquid guide hole, the third thick spherical shell liquid guide hole and the fourth thick spherical shell liquid guide hole, the fourth thick spherical shell liquid guide hole and the fourth thick spherical shell liquid guide hole have the same diameters as the first thick spherical shell hole and the fourth thick spherical shell hole.

Further, the special bracket is made of a nylon base material through cutting, and consists of a base, a cross rod, a threaded rod and a sliding block;

the upper surface of the base is etched inwards to form a cylindrical through hole, the inner diameter of the cylindrical through hole is larger than the outer diameter of the thick spherical shell main body, the depth of the cylindrical through hole is larger than the radius of the thick spherical shell main body, an annular liquid retaining groove is etched on the upper surface of the base, a second annular bulge is formed between the annular liquid retaining groove and the cylindrical through hole, and a positioning line is symmetrically etched on the outer side surface of the second annular bulge at the positions of 0 degree, 90 degrees, 180 degrees and 270 degrees; respectively and symmetrically etching four groups of first round hole arrays, second round hole arrays, third round hole arrays and fourth round hole arrays with the same inner diameter at 0 degree, 90 degrees, 180 degrees and 270 degrees on the upper surface of the base, wherein the four groups of the first round hole arrays, the second round hole arrays, the third round hole arrays and the fourth round hole arrays are close to the outer side area, each group of the round hole arrays comprises 3 round holes with the same inner diameter and threads inside, and the circle center connecting line distances of adjacent round holes in each group of the round hole arrays are the same; a first rectangular through hole is formed in the side face of the lower portion of the base, a communicating structure is formed by the first rectangular through hole and the cylindrical through hole, the width of the first rectangular through hole is not smaller than 200mm, the height of the first rectangular through hole is not smaller than 50mm, and the distance from the lower edge of the first rectangular through hole to the bottom face of the base is not smaller than 20mm; the first circular through hole and the second circular through hole are symmetrically etched on two sides of the cross rod, the first side circular through hole and the second side circular through hole are vertically etched on the side surface of the cross rod, the first circular through hole is communicated with the first side circular through hole, and the second circular through hole is communicated with the second side circular through hole; threads are arranged inside the first side circular through hole and the second side circular through hole, and screws are used for penetrating through the first side circular through hole and the second side circular through hole and screwing, so that the cross rod is kept at a fixed height on the threaded rod; etching a second rectangular through hole in the middle of the cross rod;

the threaded rods comprise two identical first threaded rods and two identical second threaded rods, threads are arranged at the bottom of each threaded rod and can be screwed into any one of the first round hole array, the second round hole array, the third round hole array and the fourth round hole array, and the diameters of the tops of the first threaded rods and the second threaded rods are smaller than the inner diameters of the first round through holes and the second round through holes;

the sliding block consists of a left sliding block and a right sliding block which have the same structure and are symmetrical to each other, a first symmetrical through hole and a second symmetrical through hole are drilled on a rectangular block at the upper half part of the left sliding block, and a first through hole is drilled on a square block at the lower half part of the left sliding block; a third symmetrical through hole and a fourth symmetrical through hole are arranged at the positions, corresponding to the first symmetrical through hole and the second symmetrical through hole, on the rectangular block at the upper half part of the right sliding block, a second through hole corresponding to the first through hole is arranged on the rectangular block at the lower half part of the right sliding block, and threads are arranged on the inner walls of all the four symmetrical through holes and the first through holes and the second through holes;

a top through hole is formed in the upper surface of the left sliding block and the right sliding block which are assembled into a whole;

the lower half part of the sliding block is provided with a T-shaped through hole, and the cross rod can be embedded into the upper half part of the T-shaped through hole;

the upper end of the first threaded rod and the upper end of the second threaded rod respectively penetrate through the first round through hole and the second round through hole, and then plastic screws are used for respectively penetrating through the first side round through hole and the second side round through hole and screwing, so that the relative positions of the cross rod and the first threaded rod and the second threaded rod are fixed; the lower end of the first threaded rod is in threaded connection with any round hole in the first round hole array, the lower end of the second threaded rod is in threaded connection with a round hole in a third round hole array in which the round holes connected with the first threaded rod are symmetrical, and the circle center connecting line between the round hole connected with the first threaded rod and the round hole connected with the second threaded rod is parallel to the circle center connecting lines of all round holes in the second round hole array and the circle center connecting lines of all round holes in the fourth round hole array; or the lower end of the first threaded rod is in threaded connection with any round hole in the second round hole array, the lower end of the second threaded rod is in threaded connection with a round hole in a fourth round hole array which is symmetrical to the round hole connected with the lower end of the first threaded rod, and the circle center connecting line between the round hole connected with the first threaded rod and the round hole connected with the second threaded rod is parallel to the circle center connecting lines of all round holes in the first round hole array and the circle center connecting lines of all round holes in the third round hole array.

Furthermore, the magnetic field measuring probe comprises a probe main body and a protective shell, three high-precision Hall elements are arranged in the probe main body, the three Hall elements are distributed in a three-dimensional orthogonal manner in space and are fixed in the rectangular probe main body, the Hall elements generate voltage signals after being stimulated by an alternating magnetic field, and the voltage signals are calculated by a control computer to obtain magnetic field signals; the data line of the three-dimensional orthogonal Hall element penetrates out of the upper part of the probe main body, and then penetrates through the protective shell to be connected with the device host; after the probe main body is assembled, resin rubber is used for filling the probe main body to realize waterproof sealing of the Hall element and the circuit board thereof, and meanwhile, the protective shell is vertically fixed on the upper surface of the probe main body; the diameter of the probe main body is smaller than that of the second rectangular through hole, the outer diameter of the protective shell is the same as the inner diameter of the top through hole, and a positioning line is etched at the upper position of the protective shell and used for positioning when the special bracket is assembled;

the magnetic field measuring probe is arranged in the second rectangular through hole, the left sliding block and the right sliding block clamp the protective shell and enable a positioning line on the protective shell to be aligned with the lower surface of the T-shaped through hole, and the cross rod is embedded in the upper half part of the T-shaped through hole;

the plastic screws respectively penetrate through the first symmetrical through hole, the third symmetrical through hole, the second symmetrical through hole and the fourth symmetrical through hole and are fixed through nuts; the plastic screw is in threaded connection with the first through hole and is screwed tightly, so that the sliding block is fixed on the cross rod.

Further, the temperature measuring module comprises a platinum resistance temperature sensor, and signals generated by the sensor are transmitted to the device host through a data line; a virtual oscilloscope module is arranged in the device host to realize the processing and storage of voltage signals generated by the Hall element in the probe main body and voltage signals generated by the temperature measurement module; the control computer controls the data acquisition process and realizes the display, processing and storage of data.

The method of the special equipment for detecting the magnetic field and the temperature of the transcranial magnetic stimulation therapeutic apparatus comprises the following steps:

step 1: designing and processing a bionic head die body, wherein the structure and the geometric dimension of the bionic head die body are close to the data of the head of a real human body; the bionic head mould body is used for forming a physiological structure similar to the head of a real human body;

step 2: preparing cerebrospinal fluid equivalent solution and brain gray matter equivalent solution according to the conductivity and relative dielectric constant of the cerebrospinal fluid and the brain gray matter of the human body; the cerebrospinal fluid equivalent solution and the brain gray matter equivalent solution are used for forming a detection environment similar to the electromagnetic characteristics of real human brain tissue;

and step 3: assembling a bionic head die body, injecting cerebrospinal fluid equivalent solution and brain gray matter equivalent solution, putting a thick spherical shell into the base, and rotating the thick spherical shell to enable the positioning lines on the edge of the thick spherical shell to correspond to the positioning lines of the second annular bulge one by one; injecting the equivalent cerebrospinal fluid solution into the thick spherical shell until the liquid level reaches one third of the internal height of the thick spherical shell, slowly placing the thin spherical shell into the thick spherical shell, and enabling the equivalent cerebrospinal fluid solution to flow upwards along the outer wall of the thin spherical shell due to extrusion of the thin spherical shell;

rotating the thin spherical shell to enable the first annular bulge to be embedded into the annular groove, and enabling the first thin spherical shell liquid guide hole, the second thin spherical shell liquid guide hole, the third thin spherical shell liquid guide hole and the fourth thin spherical shell liquid guide hole to be respectively aligned with the first thick spherical shell liquid guide hole, the second thick spherical shell liquid guide hole, the third thick spherical shell liquid guide hole and the fourth thick spherical shell liquid guide hole; cerebrospinal fluid equivalent solution exceeding the volume of the gap between the thin spherical shell and the thick spherical shell is discharged through the first thin spherical shell liquid guide hole, the second thin spherical shell liquid guide hole, the third thin spherical shell liquid guide hole, the fourth thin spherical shell liquid guide hole, the first thick spherical shell liquid guide hole, the second thick spherical shell liquid guide hole, the third thick spherical shell liquid guide hole and the fourth thick spherical shell liquid guide hole and then accumulated in an annular liquid retaining groove; finally, the gray matter equivalent solution was injected into the thin spherical shell until the liquid level reached four-fifths of the height inside the thin spherical shell.

And 4, step 4: assembling a special bracket, a magnetic field measuring probe and a temperature measuring module, screwing the lower end of a first threaded rod into any round hole of a first round hole array and connecting the round holes in a threaded manner, screwing the lower end of a second threaded rod into a round hole of a third round hole array symmetrical to the screwed round hole of the lower end of the first threaded rod and connecting the round holes in a threaded manner, wherein the circle center connecting line between the round hole connected with the first threaded rod and the round hole connected with the second threaded rod is parallel to the circle center connecting lines of all round holes in the second round hole array and the circle center connecting lines of all round holes in the fourth round hole array; or the lower end of the first threaded rod is screwed into any round hole in the second round hole array and is in threaded connection, the lower end of the second threaded rod is screwed into a round hole in a fourth round hole array which is symmetrical to the screwed round hole at the lower end of the first threaded rod and is in threaded connection, and the circle center connecting line between the round hole connected with the first threaded rod and the round hole connected with the second threaded rod is parallel to the circle center connecting line of all round holes in the first round hole array and the circle center connecting line of all round holes in the third round hole array;

then, the magnetic field measuring probe penetrates through the second rectangular through hole, the protective shell is clamped by the left sliding block and the right sliding block, a positioning line on the protective shell is aligned with the lower surface of the T-shaped through hole, and the cross rod is embedded into the upper half part of the T-shaped through hole; respectively penetrating plastic screws through the first symmetrical through hole, the third symmetrical through hole, the second symmetrical through hole and the fourth symmetrical through hole, and fixing by using nuts; meanwhile, a plastic screw penetrates through the first through hole and the second through hole and is screwed tightly, and the relative position of the sliding block and the cross rod is fixed;

integrally inserting the fixed cross rod, the fixed slide block and the magnetic field measurement probe into the brain gray matter equivalent solution in the thin spherical shell, and enabling the first threaded rod and the second threaded rod to respectively penetrate through the first round through hole and the second round through hole; adjusting the relative position of the sliding block on the cross rod, then adjusting the relative height of the cross rod and the threaded rod to enable the probe body to reach a measuring position, and finally fixing the cross rod on the first threaded rod and the second threaded rod by respectively penetrating through the first side circular through hole and the second side circular through hole by using plastic screws; sticking the temperature measuring module on the surface of a stimulating coil of the transcranial magnetic stimulation therapeutic apparatus;

and 5: setting a stimulation sequence of the transcranial magnetic stimulation therapeutic apparatus, starting magnetic field and temperature detection, inserting a stimulation coil of the transcranial magnetic stimulation therapeutic apparatus into a first rectangular through hole, enabling the center of the stimulation coil to be tightly attached but not extruding a thick-shell thin spherical shell main body, and if the stimulation coil cannot be tightly attached, inserting an acrylic plate into the first rectangular through hole to lift the stimulation coil; and (3) using a repeated pulse stimulation mode, measuring the maximum magnetic induction intensity, the spatial magnetic field distribution, the output frequency, the stimulation pulse width and the coil surface temperature after the probe main body reaches the measurement position, and carrying out data analysis and uncertainty evaluation on the measurement result.

Further, the method for preparing equivalent cerebrospinal fluid solution and equivalent brain gray solution is to use primary pure water as a basic substance, and adjust the conductivity and relative dielectric constant of the equivalent tissue solution by adding salts and saccharides, so that the conductivity and relative dielectric constant of the two equivalent solutions are respectively equivalent to the real human cerebrospinal fluid and the brain gray, wherein the conductivity of the real human cerebrospinal fluid is 1.00-2.51S/m, the relative dielectric constant is 109 +/-30, the conductivity of the real human brain gray is 0.06-2.47S/m, and the relative dielectric constant is 85600 +/-25000. The relative dielectric constants were measured and calibrated at a frequency of 2.8kHz.

Further, the method for selecting the measuring position of the probe body in the step 4 of the method comprises the following steps: introducing numerical models corresponding to the thin spherical shell and the thick spherical shell into analog simulation software, assigning the electric conductivity and the relative dielectric constant of the thin spherical shell and the thick spherical shell to values corresponding to human skull, assigning the space between the thin spherical shell and the thick spherical shell to the electric conductivity and the relative dielectric constant of cerebrospinal fluid, and assigning the space inside the thin spherical shell to the electric conductivity and the relative dielectric constant of cerebral gray matter; then, the commonly used circular stimulating coil and 8-shaped stimulating coil of the transcranial magnetic stimulation therapeutic apparatus are abstractly established into numerical models with geometrical structural characteristics of respective coil radius, turn number and the like, and parameters such as current intensity, current frequency and the like in the numerical models of the stimulating coils are assigned as corresponding numerical values of the stimulating sequence in the step 5;

calculating and obtaining the magnetic field distribution of the inner space of the thin spherical shell when different stimulating coils are used based on a finite element method; selecting a proper measuring position according to the distribution characteristics of the magnetic field aiming at different stimulating coils, and particularly, when the maximum magnetic induction intensity, the output frequency and the stimulating pulse width of all stimulating coils are measured, placing the probe main body at the lowest position of the inner side of the thin spherical shell; when the magnetic field distribution in the thin spherical shell is measured, proper spatial position coordinates, namely x coordinates, y coordinates and z coordinates, are selected according to the structures of the first round hole array, the second round hole array, the third round hole array and the fourth round hole array and the magnetic field distribution characteristics of different stimulation coils.

Further, in the space position x coordinate, the y coordinate and the z coordinate, the x coordinate is determined by the structures and the positions of the first round hole array, the second round hole array, the third round hole array and the fourth round hole array, the y coordinate is determined by the relative position of the sliding block and the cross rod, and the z coordinate is determined by the depth of the probe main body inserted into the thin spherical shell.

Further, the method for positioning the measurement position of the probe body in the step 4 of the method comprises the following steps: before the measuring position is positioned each time, firstly adjusting the relative position of the sliding block on the cross bar, using a steel ruler to measure the distance between each of the two side surfaces of the sliding block and the tail end of the cross bar at the same side until the sliding block is positioned at the central position of the cross bar, and secondly adjusting the relative height of the cross bar and the threaded rod to ensure that the surface of the tail end of the protective shell is superposed with the plane of the upper surface of the edge of the thin spherical shell;

during positioning, screwing the first threaded rod and the second threaded rod into the symmetrical round hole arrays corresponding to the base according to the selected measuring position, and determining an x coordinate; then moving the slide block and measuring the distance between each of the two side surfaces of the slide block and the tail end of the transverse rod on the same side by using a straight steel ruler until a target y coordinate is reached; and changing the insertion depth of the probe main body, and measuring the distance between the positioning line on the protective shell and the lower surface of the T-shaped through hole by using the steel ruler until the target z coordinate is reached.

Further, it is characterized in that: the method comprises the following specific steps of detecting the magnetic field and the temperature in step 4: for any parameter and any measurement position, at least more than 6 times of results are obtained through continuous measurement, and the average value is taken as a final measurement result.

Further wherein the data analysis and uncertainty assessment in step 5 of the method comprises the steps of:

step 5-1: tracing the straight steel ruler to a national length standard, tracing the magnetic field measuring probe to a national electromagnetic standard, tracing the temperature measuring module to a national temperature standard, and obtaining the accuracy grade, resolution or uncertainty of the equipment;

step 5-2: for the obtained magnetic field intensity measurement result or temperature measurement result, rejecting outliers according to a Dickson criterion, and calculating the standard deviation of the evaluated parameters according to the measurement times;

step 5-3: and (3) evaluating uncertainty of the magnetic field strength measurement result or the temperature measurement result, analyzing the A-type standard uncertainty and the B-type standard uncertainty introduced by the straightedge, the magnetic field measurement probe, the temperature measurement module and the like according to the accuracy grade, the resolution or the uncertainty obtained in the step 5-1, analyzing the correlation of the several types of uncertainty, synthesizing the expanded uncertainty, and evaluating the degree of the measurement result.

Compared with the prior art, the invention has obvious advantages and beneficial effects. It has at least the following advantages:

1. the bionic head die body developed by the invention is of a double-layer spherical shell structure, a thick spherical shell is used for simulating a human skull, a thin spherical shell is used for separating cerebrospinal fluid equivalent solution and cerebral gray matter equivalent solution, the sum of the thicknesses of the thick spherical shell and the thin spherical shell is similar to the thickness of the human skull, the width of a gap between the thick spherical shell and the thin spherical shell is similar to the thickness of the cerebrospinal fluid layer of the human body, and the inner diameter of the thin spherical shell is similar to the size of the cerebral gray matter of the human body; the bionic head die body formed by the thick spherical shell and the thin spherical shell has a structure similar to that of the head of a human body, and the die body can approximate the real situation of the head of the human body from the structural form.

2. The bionic head mold body developed by the invention is made of acrylic materials, and the bioelectromagnetic characteristics of the bionic head mold body are similar to those of human bones; the conductivity and dielectric constant of cerebrospinal fluid equivalent solution and brain gray matter equivalent solution poured into the bionic head die body are equivalent to those of corresponding human tissues; since the dielectric constant measurements are related to the frequency of the electromagnetic field environment applied to the tissue equivalent solution, the solution dielectric constant measurements were performed at the frequency of 2.8kHz, the alternating magnetic field frequency commonly used for TMS devices.

3. The magnetic field measuring probe developed by the invention develops a three-axis orthogonal measuring probe from a component level (Hall element), and can realize the measurement of the intensity of alternating magnetic field; because the frequency of an alternating magnetic field commonly used by the TMS therapeutic apparatus is 2.8kHz, according to the Nyquist sampling theorem, the sampling frequency of the magnetic field measuring probe researched and developed by the invention reaches 10kHz, the measuring range covers (0-4) T, and the measuring resolution is 25mT, so that the waveform of a stimulation sequence acquired by collection can be ensured not to be distorted.

4. The invention adopts an analog simulation method to determine the measuring position, introduces numerical models of a bionic head die body and a stimulating coil into analog simulation software, assigns the bionic head die body, the inner space of the die body and the stimulating coil as corresponding electromagnetic characteristic parameters or current parameters, then adopts a finite element method to calculate and obtain the magnetic field distribution of the inner space of the bionic head die body, and selects and determines the measuring position according to the magnetic field distribution; the measuring position selecting method selects the measuring position according to the distribution of the magnetic field in the bionic head die body, can select the proper measuring position according to different measuring purposes, and can guide the positioning of the measuring probe and ensure that the measuring probe is placed at the target position by the measuring position coordinate.

5. The method comprises the steps of tracing the length measurement result of the straight steel ruler to the national length standard, tracing the magnetic field measurement result of the magnetic field measurement probe to the national electromagnetic standard, tracing the temperature measurement module to the national temperature standard, and obtaining the uncertainty corresponding to the 3 types of measurement results; and carrying out uncertainty evaluation on the magnetic field intensity measurement result and the temperature measurement result, analyzing the A-type standard uncertainty and the B-type standard uncertainty, and finally synthesizing and expanding the uncertainty so as to evaluate the feasibility degree of the measurement result.

The foregoing description is only an overview of the technical solutions of the present invention, and in order to make the technical solutions of the present invention more clearly understood and to implement them in accordance with the contents of the description, the following detailed description is given with reference to the preferred embodiments of the present invention and the accompanying drawings.

Drawings

FIG. 1: the invention relates to a structural schematic diagram of special equipment for detecting a magnetic field and temperature of a transcranial magnetic stimulation therapeutic apparatus.

Wherein:

1: thin spherical shell 2: thick spherical shell

3: base 4: cross bar

5: threaded rod 6: sliding block

7: magnetic field measurement probe 8: temperature measuring module

9: the device host 10: control computer

11: data line

FIG. 2A: the invention discloses a structural schematic diagram of a bionic head mold body.

FIG. 2B: the invention discloses a thin spherical shell structure schematic diagram of a bionic head die body.

Wherein:

1: thin spherical shell

1-1: first thin spherical shell drain hole 1-2: second thin spherical shell liquid guide hole

1-3: and a third thin spherical shell drain hole 1-4: fourth thin spherical shell drain hole

1-5: thin spherical shell main body 1-6: edge of thin spherical shell

1-7: annular groove

FIG. 2C: the invention discloses a thick spherical shell structure schematic diagram of a bionic head die body.

Wherein:

2: thick spherical shell

2-1: the first thick spherical shell drain hole 2-2: second thick spherical shell drain hole

2-3: and a third thick spherical shell drain hole 2-4: fourth thick spherical shell drain hole

2-5: thick spherical shell main body 2-6: thick spherical shell edge

2-7: a first annular bulge

FIG. 3A: the special bracket structure of the invention is schematically shown.

FIG. 3B: the invention discloses a base structure schematic diagram of a special bracket.

Wherein:

3: base seat

3-1: first circular hole array 3-2: second circular hole array

3-3: third circular hole array 3-4: fourth circular hole array

3-5: annular liquid retention tanks 3-6: second annular bulge

3-7: cylindrical through hole 3-8: a first rectangular through hole

FIG. 3C: the structure of the cross bar of the special bracket of the invention is schematically shown

Wherein:

4: cross bar

4-1: first circular through hole 4-2: second round through hole

4-3: first side round through hole 4-4: second side round through hole

4-5: second rectangular through hole

FIG. 3D: the invention discloses a threaded rod structure schematic diagram of a special bracket.

5: threaded rod

5-1: first threaded rod 5-2: second threaded rod

FIG. 3E: the left side view of the slide block structure of the special bracket is schematic.

FIG. 3F: the right side view of the slide block structure of the special bracket is schematic.

Wherein:

6: sliding block

6-1: 6-2 of left slide block: right slide block

6-3: first symmetric via 6-4: second symmetrical through hole

6-5: third symmetrical through holes 6-6: fourth symmetrical via

6-7: first through-hole 6-8: second through hole

6-9: top through hole 6-10: t-shaped through hole

FIG. 4A: the invention discloses a structure schematic diagram of a magnetic field measuring probe.

Wherein:

7: magnetic field measuring probe

7-1: probe body 7-2: protective casing

FIG. 4B: the invention discloses a schematic diagram of the internal structure of a probe body of a magnetic field measuring probe.

FIG. 5: the invention is a schematic diagram of measurement software.

Wherein:

12: measurement software

12-1: magnetic field measurement window 12-2: temperature measuring window

FIG. 6: the invention discloses a schematic diagram of the measurement positions of the maximum magnetic induction intensity and the surface temperature of a coil.

Wherein:

13: stimulating coil

13-1: measurement positions 1-2: measuring position 2

13-3: measurement positions 3-4: measuring position 4

FIG. 7: the invention discloses a space magnetic field distribution measuring point schematic diagram.

Detailed Description

To further illustrate the technical means and effects of the present invention adopted to achieve the predetermined objects, the following detailed description will be given of specific embodiments, methods, steps, features and effects of a special device and method for detecting magnetic field and temperature of transcranial magnetic stimulation therapeutic apparatus according to the present invention with reference to the accompanying drawings and preferred embodiments.

Referring to fig. 1, the special device for detecting the magnetic field and temperature of the transcranial magnetic stimulation therapeutic apparatus according to the preferred embodiment of the present invention comprises a bionic head mold, a special bracket, a magnetic field measuring probe 7, a temperature measuring module 8, a device host 9, a control computer 10, a data line 11 and a measuring software 12; the bionic head die body is arranged on the base 3 of the special support, the magnetic field measuring probe 7 is arranged on the top of the sliding block 6 of the special support, and the device host 9 is respectively connected with the magnetic field measuring probe 7, the temperature measuring module 8 and the control computer 10 through data lines 11; the temperature measuring module 8 comprises a platinum resistance temperature sensor, signals generated by the temperature sensor are transmitted to the device host 9 through a data line 11, a virtual oscilloscope module is arranged in the device host 9, processing and storage of voltage signals generated by the Hall element in the probe main body 7-1 and voltage signals generated by the temperature measuring module 9 are realized, and a control computer 10 controls a data acquisition process and realizes display, processing and storage of data. The measurement software 12 is installed in the control computer 10, and the measurement software 12 is provided with a magnetic field measurement window 12-1 and a temperature measurement window 12-2, as shown in fig. 5.

Referring to fig. 2A, the bionic head mold body is composed of a thin spherical shell 1 and a thick spherical shell 2, and the thin spherical shell 1 and the thick spherical shell 2 are an integral structure formed by cutting a cylindrical acrylic substrate.

Referring to fig. 2B, the thin spherical shell 1 is composed of a thin spherical shell main body 1-5 and a thin spherical shell edge 1-6, wherein the thin spherical shell main body 1-5 is a hemisphere with a wall thickness of not more than 3mm and an inner diameter of 140-150 mm, a first thin spherical shell liquid guide hole 1-1, a second thin spherical shell liquid guide hole 1-2, a third thin spherical shell liquid guide hole 1-3 and a fourth thin spherical shell liquid guide hole 1-4 are symmetrically etched at 0 °, 90 °, 180 ° and 270 ° on the lower edge of the thin spherical shell edge 1-6, and an annular groove 1-7 is etched at a position close to the thin spherical shell main body 1-5 on the lower edge of the thin spherical shell edge 1-6.

Referring to FIG. 2C, the thick spherical shell 2 comprises a thick spherical shell main body 2-5 and a thick spherical shell edge 2-6, wherein the thick spherical shell main body 2-5 is a hemisphere with a wall thickness not more than 12mm and an inner diameter of 150-165 mm, a first annular protrusion 2-7 is arranged above the thick spherical shell edge 2-6 and along the inner edge of the thick spherical shell main body 2-5, a first thick spherical shell liquid guide hole 2-1, a second thick spherical shell liquid guide hole 2-2, a third thick spherical shell liquid guide hole 2-3 and a fourth thick spherical shell liquid guide hole 2-4 are respectively and symmetrically etched at 0 degree, 90 degree, 180 degree and 270 degree positions of the first annular protrusion 2-7, and a positioning line is respectively etched on the side face of the edge 2-6 of the thick spherical shell and opposite to the central positions of the first thick spherical shell liquid guide hole 2-1, the second thick spherical shell liquid guide hole 2-2, the third thick spherical shell liquid guide hole 2-3 and the fourth thick spherical shell liquid guide hole 2-4, the first annular bulge 2-7 is embedded into the annular groove 1-7, and the first thick spherical shell liquid guide hole 2-1, the second thick spherical shell liquid guide hole 2-2, the third thick spherical shell liquid guide hole 2-3 and the fourth thick spherical shell liquid guide hole 2-4 correspond to the first thin spherical shell liquid guide hole 1-1, the second thin spherical shell liquid guide hole 1-2, the third thin spherical shell liquid guide hole 1-3 and the fourth thin spherical shell liquid guide hole 1-4 one by one and have the same diameter.

Referring to fig. 3A and 3B, the special bracket is made of nylon base material by cutting, and the special bracket is composed of a base 3, a cross bar 4, a threaded rod 5 and a sliding block 6. The upper surface of a base 3 is etched inwards to form a cylindrical through hole 3-7, the inner diameter of the cylindrical through hole 3-7 is larger than the outer diameter of a thick spherical shell main body 2-5, the depth of the cylindrical through hole 3-7 is larger than the radius of the thick spherical shell main body 2-5, an annular liquid retaining groove 3-5 is etched on the upper surface of the base 3, the rest part between the annular liquid retaining groove 3-5 and the cylindrical through hole 3-7 forms a second annular bulge 3-6, 0 degrees, 90 degrees, 180 degrees and 270 degrees of positions on the outer side surface of the second annular bulge 3-6 are respectively and symmetrically etched with one positioning line, 0 degrees, 90 degrees, 180 degrees and 270 degrees of positions on the upper surface of the base 3 close to an outer side area are respectively and symmetrically etched with four groups of a first round hole array 3-1, a second round hole array 3-2, a third round hole array 3-3 and a fourth round hole array 3-4 which are the same in inner diameter, each group of round hole array comprises 3 round holes which are the same in inner diameter and are internally provided with threads, and the connecting lines of adjacent round holes in each group of round hole array are the same distance; the side face of the lower portion of the base 3 is provided with a first rectangular through hole 3-8, the first rectangular through hole 3-8 and the cylindrical through hole 3-7 form a communicating structure, the width of the first rectangular through hole 3-8 is not less than 200mm, the height of the first rectangular through hole 3-8 is not less than 50mm, and the distance from the lower edge of the first rectangular through hole 3-8 to the bottom face of the base 3 is not less than 20mm.

Referring to fig. 3C, a first circular through hole 4-1 and a second circular through hole 4-2 are symmetrically etched on both sides of a cross bar 4, a first side circular through hole 4-3 and a second side circular through hole 4-4 are vertically etched on the side surface of the cross bar 4, the first circular through hole 4-1 is communicated with the first side circular through hole 4-3, the second circular through hole 4-2 is communicated with the second side circular through hole 4-4, threads are arranged inside the first side circular through hole 4-3 and the second side circular through hole 4-4, and screws are used to pass through the first side circular through hole 4-3 and the second side circular through hole 4-4 and screwed, so that the cross bar 4 is maintained at a fixed height on a threaded rod 5; and etching a second rectangular through hole 4-5 in the middle of the cross rod 4.

Referring to fig. 3A, 3B, 3C and 3D, the threaded rod 5 includes two identical first threaded rods 5-1 and second threaded rods 5-2, each threaded rod is provided with threads at the bottom and can be screwed into any one of the first circular hole array 3-1, the second circular hole array 3-2, the third circular hole array 3-3 and the fourth circular hole array 3-4, and the diameters of the tops of the first threaded rod 5-1 and the second threaded rod 5-2 are slightly smaller than the inner diameters of the first circular through hole 4-1 and the second circular through hole 4-2. The upper end of the first threaded rod 5-1 and the upper end of the second threaded rod 5-2 respectively penetrate through the first round through hole 4-1 and the second round through hole 4-2, and then plastic screws respectively penetrate through the first side round through hole 4-3 and the second side round through hole 4-4 and are screwed tightly, so that the relative positions of the cross rod 4 and the first threaded rod 5-1 and the second threaded rod 5-2 are fixed; the lower end of a first threaded rod 5-1 is in threaded connection with any round hole in a first round hole array 3-1, the lower end of a second threaded rod 5-2 is in threaded connection with a round hole in a third round hole array 3-3, wherein the round holes connected with the first threaded rod 5-1 are symmetrical, and the circle center connecting line between the round hole connected with the first threaded rod 5-1 and the round hole connected with the second threaded rod 5-2 is parallel to the circle center connecting lines of all round holes in the second round hole array 3-2 and the circle center connecting lines of all round holes in a fourth round hole array 3-4; or the lower end of the first threaded rod 5-1 is in threaded connection with any round hole in the second round hole array 3-2, the lower end of the second threaded rod 5-2 is in threaded connection with a round hole in a fourth round hole array 3-4 which is symmetrical to the round hole connected with the lower end of the first threaded rod 5-1, and the circle center connecting line between the round hole connected with the first threaded rod 5-1 and the round hole connected with the second threaded rod 5-2 is parallel to the circle center connecting lines of all round holes in the first round hole array 3-1 and the circle center connecting lines of all round holes in the third round hole array 3-3.

Referring to fig. 3E and 3F, the slider 6 is composed of a left slider 6-1 and a right slider 6-2 which have the same structure and are symmetrical to each other, a first symmetrical through hole 6-3 and a second symmetrical through hole 6-4 are drilled on a rectangular block at the upper half part of the left slider 6-1, and a first through hole 6-7 is drilled on a rectangular block at the lower half part of the left slider 6-1; a third symmetrical through hole 6-5 and a fourth symmetrical through hole 6-6 are arranged at the positions, corresponding to the first symmetrical through hole 6-3 and the second symmetrical through hole 6-4, on the rectangular block at the upper half part of the right sliding block 6-2, a second through hole 6-8 corresponding to the first through hole 6-7 is arranged on the square block at the lower half part of the right sliding block 6-2, and threads are arranged on the inner walls of all the four symmetrical through holes, the first through hole 6-7 and the second through hole 6-8; after the left sliding block 6-1 and the right sliding block 6-2 are assembled together, a top through hole 6-9 is drilled on the upper surface of the left sliding block 6-1 and the right sliding block 6-2 which are assembled into a whole; the lower half part of the sliding block 6 is provided with T-shaped through holes 6-10, and the cross rod 4 can be embedded into the upper half parts of the T-shaped through holes 6-10.

Referring to fig. 4A and 4B, the magnetic field measurement probe 7 includes a probe main body 7-1 and a protective casing 7-2, three high-precision hall elements are built in the probe main body 7-1, the three hall elements are spatially distributed in a three-dimensional orthogonal manner and fixed in the rectangular probe main body 7-1, and voltage signals generated by the hall elements after being stimulated by an alternating magnetic field are calculated by a control computer 10 to obtain magnetic field signals; a data line of the three-dimensional orthogonal Hall element penetrates out of the upper part of the probe main body 7-1, then penetrates through the protective shell 7-2 and is connected with the device host 9; after the probe main body 7-1 is assembled, the probe main body 7-1 is filled with resin rubber to realize waterproof sealing of the Hall element and a circuit board thereof, and meanwhile, the protective shell 7-2 is vertically fixed on the upper surface of the probe main body 7-1; the diameter of the probe main body 7-1 is smaller than that of the second rectangular through hole 4-5, and the outer diameter of the protective shell 7-2 is the same as the inner diameter of the top through hole 6-9; and a positioning line is etched at the upper position of the protective shell 7-2 and used for positioning when the special bracket is assembled.

Referring to fig. 1, 3, 4A and 4B, the magnetic field measuring probe 7 is installed in the second rectangular through hole 4-5, the left slider 6-1 and the right slider 6-2 clamp the protective casing 7-2 and make the positioning line on the protective casing 7-2 aligned with the lower surface of the T-shaped through hole 6-10, and the cross bar 4 is embedded in the upper half of the T-shaped through hole 6-10; the plastic screws respectively penetrate through the first symmetrical through hole 6-3, the third symmetrical through hole 6-5, the second symmetrical through hole 6-4 and the fourth symmetrical through hole 6-6 and are fixed through nuts; the plastic screw is in threaded connection with the first through hole 6-7 and the first through hole 6-8 and is screwed tightly, so that the sliding block 6 is fixed on the cross rod 4.

The method adopting the special equipment for detecting the magnetic field and the temperature of the transcranial magnetic stimulation therapeutic apparatus comprises the following steps:

step 1: designing and processing a bionic head die body, wherein the structure and the geometric dimension of the bionic head die body are close to the data of the head of a real human body; the bionic head mold body is used for forming a physiological structure similar to the head of a real human body;

and 2, step: preparing a cerebrospinal fluid equivalent solution and a brain gray matter equivalent solution according to the conductivity and the relative dielectric constant of the cerebrospinal fluid and the brain gray matter of the human body; the cerebrospinal fluid equivalent solution and the brain gray matter equivalent solution are used for forming a detection environment similar to the electromagnetic characteristics of real human brain tissue;

the method for preparing the equivalent cerebrospinal fluid solution and the equivalent brain gray solution is characterized in that primary pure water is used as a basic substance, and the electrical conductivity and the relative dielectric constant of the equivalent tissue solution are adjusted by adding salts and saccharides, so that the electrical conductivity and the relative dielectric constant of the two equivalent tissue solutions are respectively equivalent to the actual human cerebrospinal fluid and the brain gray, wherein the electrical conductivity of the actual human cerebrospinal fluid is 1.00-2.51S/m, the relative dielectric constant is 109 +/-30, the electrical conductivity of the actual human brain gray is 0.06-2.47S/m, and the relative dielectric constant is 85600 +/-25000. The relative dielectric constants were measured and calibrated at a frequency of 2.8kHz.

And step 3: assembling a bionic head die body, injecting cerebrospinal fluid equivalent solution and brain gray matter equivalent solution, placing the thick spherical shell 2 into the base 3, and rotating the thick spherical shell 2 to enable the positioning lines of the edges 2-6 of the thick spherical shell to correspond to the positioning lines of the second annular bulges 3-6 one by one; injecting the equivalent cerebrospinal fluid solution into the thick spherical shell 2 until the liquid level reaches one third of the internal height of the thick spherical shell 2, then slowly placing the thin spherical shell 1 into the thick spherical shell 2, and enabling the equivalent cerebrospinal fluid solution to flow upwards along the outer wall of the thin spherical shell 1 due to extrusion of the thin spherical shell;

rotating the thin spherical shell 1 to enable the first annular bulge 2-7 to be embedded into the annular groove 1-7, and enabling the first thin spherical shell liquid guide hole 1-1, the second thin spherical shell liquid guide hole 1-2, the third thin spherical shell liquid guide hole 1-3 and the fourth thin spherical shell liquid guide hole 1-4 to be respectively aligned with the first thick spherical shell liquid guide hole 2-1, the second thick spherical shell liquid guide hole 2-2, the third thick spherical shell liquid guide hole 2-3 and the fourth thick spherical shell liquid guide hole 2-4;

cerebrospinal fluid equivalent solution exceeding the volume of the gap between the thin spherical shell 1 and the thick spherical shell 2 is discharged through a first thin spherical shell liquid guide hole 1-1, a second thin spherical shell liquid guide hole 1-2, a third thin spherical shell liquid guide hole 1-3, a fourth thin spherical shell liquid guide hole 1-4, a first thick spherical shell liquid guide hole 2-1, a second thick spherical shell liquid guide hole 2-2, a third thick spherical shell liquid guide hole 2-3 and a fourth thick spherical shell liquid guide hole 2-4 and then accumulated in an annular liquid retaining groove 3-5; finally, the gray matter equivalent solution was injected into the thin spherical shell 1 until the liquid level reached four fifths of the height inside the thin spherical shell 1.

And 4, step 4: assembling a special bracket, a magnetic field measuring probe 7 and a temperature measuring module 8, screwing the lower end of a first threaded rod 5-1 into any one round hole of a first round hole array 3-1 and connecting the round holes in a threaded manner, screwing the lower end of a second threaded rod 5-2 into a round hole of a third round hole array 3-3 symmetrical to the screwed round hole of the lower end of the first threaded rod 5-1 and connecting the round holes in the third round hole array in a threaded manner, wherein the circle center connecting line between the round hole connected with the first threaded rod 5-1 and the round hole connected with the second threaded rod 5-2 is parallel to the circle center connecting lines of all round holes in the second round hole array 3-2 and the circle center connecting lines of all round holes in a fourth round hole array 3-4; or the lower end of the first threaded rod 5-1 is screwed into any round hole of the second round hole array 3-2 and is in threaded connection, the lower end of the second threaded rod 5-2 is screwed into a round hole of the fourth round hole array 3-4 which is symmetrical to the screwed round hole of the lower end of the first threaded rod 5-1 and is in threaded connection, and the circle center connecting line between the round hole connected with the first threaded rod 5-1 and the round hole connected with the second threaded rod 5-2 is parallel to the circle center connecting line of all round holes in the first round hole array 3-1 and the circle center connecting line of all round holes in the third round hole array 3-3;

then, the magnetic field measuring probe 7 penetrates through the second rectangular through hole 4-5, the protective shell 7-2 is clamped by the left sliding block 6-1 and the right sliding block 6-2, a positioning line on the protective shell 7-2 is aligned with the lower surface of the T-shaped through hole 6-10, and the cross rod 4 is embedded into the upper half part of the T-shaped through hole 6-10; respectively penetrating plastic screws through the first symmetrical through hole 6-3, the third symmetrical through hole 6-5, the second symmetrical through hole 6-4 and the fourth symmetrical through hole 6-6, and fixing by using nuts; meanwhile, plastic screws are used to penetrate through the first through holes 6-7 and the first through holes 6-8 and are screwed tightly, and the relative positions of the sliding block 6 and the cross rod 4 are fixed;

integrally inserting the fixed cross rod 4, the fixed slide block 6 and the fixed magnetic field measuring probe 7 into the cerebral gray matter equivalent solution in the thin spherical shell 1, and enabling the first threaded rod 5-1 and the second threaded rod 5-2 to respectively penetrate through the first round through hole 4-1 and the second round through hole 4-2; adjusting the relative position of the sliding block 6 on the cross rod 4, then adjusting the relative height of the cross rod 4 and the threaded rod 5 to enable the probe main body 7-1 to reach a measuring position, and finally fixing the cross rod 4 on the first threaded rod 5-1 and the second threaded rod 5-2 by respectively penetrating through the first side circular through hole 4-3 and the second side circular through hole 4-4 by using plastic screws; sticking the temperature measuring module 8 on the surface of a stimulating coil of the transcranial magnetic stimulation therapeutic apparatus;

the selection method of the measuring position of the probe body 7-1 comprises the following steps: introducing numerical models corresponding to the thin spherical shell 1 and the thick spherical shell 2 into analog simulation software, assigning the conductivities and the relative dielectric constants of the thin spherical shell 1 and the thick spherical shell 2 to numerical values corresponding to human skull, assigning the space between the thin spherical shell 1 and the thick spherical shell 2 to the conductivity and the relative dielectric constant of cerebrospinal fluid, and assigning the space inside the thin spherical shell 1 to the conductivity and the relative dielectric constant of cerebral gray matter; then, the commonly used circular stimulating coil and 8-shaped stimulating coil of the transcranial magnetic stimulation therapeutic apparatus are abstractly established into numerical models with geometrical structural characteristics of respective coil radius, turn number and the like, and current intensity and current frequency characteristic parameters in the numerical models of the stimulating coils are assigned to corresponding numerical values of the stimulating sequence in the step 5;

calculating and obtaining the magnetic field distribution of the inner space of the thin spherical shell 1 when different stimulating coils are used based on a finite element method; selecting a proper measuring position according to the distribution characteristics of the magnetic field aiming at different stimulating coils, and particularly, when the maximum magnetic induction intensity, the output frequency and the stimulating pulse width of all stimulating coils are measured, placing the probe main body 7-1 at the lowest position of the inner side of the thin spherical shell 1; when the magnetic field distribution in the space inside the thin spherical shell 1 is measured, appropriate space position coordinates, namely x coordinates, y coordinates and z coordinates, are selected according to the structures of the first round hole array 3-1, the second round hole array 3-2, the third round hole array 3-3 and the fourth round hole array 3-4 and the magnetic field distribution characteristics of different stimulation coils. In the space position x coordinate, the y coordinate and the z coordinate, the x coordinate is determined by the structures and the positions of the first circular hole array 3-1, the second circular hole array 3-2, the third circular hole array 3-3 and the fourth circular hole array 3-4, the y coordinate is determined by the relative position of the sliding block 6 and the cross rod 4, and the z coordinate is determined by the depth of the probe main body 7-1 inserted into the thin spherical shell 1.

The positioning method of the measuring position of the probe main body 7-1 comprises the following steps: before the measuring position is positioned each time, firstly adjusting the relative position of the sliding block 6 on the cross bar 4, using a steel ruler to measure the distance between each of the two side surfaces of the sliding block 6 and the tail end of the cross bar 4 on the same side until the sliding block 6 is positioned at the central position of the cross bar 4, and secondly adjusting the relative height between the cross bar 4 and the threaded rod 5 to ensure that the tail end surface of the protective shell 7-2 is superposed with the plane of the upper surface of the edge 1-6 of the thin spherical shell;

when in positioning, the first threaded rod 5-1 and the second threaded rod 5-2 are screwed into the symmetrical circular hole array corresponding to the base 3 according to the selected measuring position, and the x coordinate is determined; then moving the slide block 6 and measuring the distance between each of the two side surfaces of the slide block and the tail end of the transverse rod 4 on the same side by using a steel ruler until a target y coordinate is reached; the insertion depth of the probe main body 7-1 is changed, and the distance between the positioning line on the protective shell 7-2 and the lower surface of the T-shaped through hole 6-10 is measured by using a straight steel ruler until the target z coordinate is reached.

The magnetic field and temperature detection method specifically comprises the following steps: for any parameter and any measurement position, at least more than 6 times of results are obtained through continuous measurement, and the average value is taken as a final measurement result.

And 5: setting a stimulation sequence of the transcranial magnetic stimulation therapeutic apparatus, starting magnetic field and temperature detection, inserting a stimulation coil of the transcranial magnetic stimulation therapeutic apparatus into the first rectangular through hole 3-8, enabling the center of the stimulation coil to be tightly attached but not extruding the thick-shell thin spherical shell main body 2-5, and if the stimulation coil cannot be tightly attached, inserting an acrylic plate into the first rectangular through hole 3-8 to lift the stimulation coil; and (3) using a repeated pulse stimulation mode, measuring the maximum magnetic induction intensity, the spatial magnetic field distribution, the output frequency, the stimulation pulse width and the coil surface temperature after the probe main body 7-1 reaches a measurement position, and analyzing data and evaluating uncertainty of a measurement result. Wherein the data analysis and uncertainty assessment comprises the steps of:

step 5-1: tracing the straight steel ruler to the national length reference, tracing the magnetic field measuring probe 7 to the national electromagnetic standard, tracing the temperature measuring module 8 to the national temperature reference, and obtaining the self accuracy grade, resolution or uncertainty of the equipment;

step 5-3: and (3) evaluating uncertainty of the magnetic field strength measurement result or the temperature measurement result, analyzing the A-type standard uncertainty and the B-type standard uncertainty introduced by the straightedge, the magnetic field measurement probe 7, the temperature measurement module 8 and the like according to the accuracy grade, the resolution or the uncertainty obtained in the step 5-1, analyzing the correlation of the uncertainties and synthesizing the expanded uncertainty, thereby evaluating the degree of measurement result.

Referring to fig. 1-7, a method for detecting magnetic field and temperature of a transcranial magnetic stimulation therapeutic apparatus according to a preferred embodiment of the present invention mainly includes the following steps:

firstly, designing and processing a bionic head mould body, wherein the size of the bionic head mould body is approximate to the size of a real human head structure, and the tissue electromagnetic property is equivalent under a transcranial magnetic stimulation coverage frequency band.

Fig. 2A-2C show the design of a bionic head mold body. The bionic head die body is similar to the structure size of the head of a real human body, the tissue electromagnetic characteristics are equivalent under the transcranial magnetic stimulation coverage frequency band, the die body structure is light and handy, and the assembly and the transportation are convenient.

Referring to fig. 2B, the thin spherical shell 1, which serves as a barrier between gray matter and cerebrospinal fluid, should maintain high rigidity and high stability, and is composed of a thin spherical shell body 1-5 having a wall thickness of 3mm and an inner diameter of 148mm and a thin spherical shell rim 1-6 having a width of 26mm (including the wall thickness of the thin spherical shell body 1-5). Wherein, the positions of 0 degree, 90 degree, 180 degree and 270 degree on the lower edge of the edge 1-6 of the thin spherical shell are symmetrically etched with a first thin spherical shell edge liquid guide hole 1-1, a second thin spherical shell edge liquid guide hole 1-2, a third thin spherical shell edge liquid guide hole 1-3 and a fourth thin spherical shell edge liquid guide hole 1-4 which are 10mm wide, 5mm deep and 5mm long, and the position of the edge 1-6 of the thin spherical shell close to the thin spherical shell main body 1-5 is etched with an annular groove 1-7 which is 10mm wide and 10mm deep.

Referring to fig. 2C, the thick spherical shell 2 is used to simulate the scalp-skull layer and is composed of a thick spherical shell body 2-5 having a wall thickness of 12mm and an inner diameter of 160mm and a thick spherical shell rim 2-6 having a width of 20mm (including the wall thickness of the thick spherical shell body 2-5). A first annular bulge 2-7 with the width of 7mm and the height of 5mm is arranged above the inner edge of the thick spherical shell main body 2-5. And symmetrically etching a first thick spherical shell liquid guide hole 2-1, a second thick spherical shell liquid guide hole 2-2, a third thick spherical shell liquid guide hole 2-3 and a fourth thick spherical shell liquid guide hole 2-4 with the diameters of 10mm at the positions of 0 degree, 90 degrees, 180 degrees and 270 degrees of the first annular bulge 2-7. Four positioning lines are etched on the side face of the edge 2-6 of the thick spherical shell, the center positions of the first thick spherical shell liquid guide hole 2-1, the second thick spherical shell liquid guide hole 2-2, the third thick spherical shell liquid guide hole 2-3 and the fourth thick spherical shell liquid guide hole 2-4. The outer diameter of the thin spherical shell main body 1-5 is slightly smaller than the inner diameter of the thick spherical shell main body 2-5, the outer diameter of the thin spherical shell edge 1-6 is the same as the outer diameter of the thick spherical shell edge 2-6 in size, the width of the annular bulge 2-7 is smaller than the width of the thick spherical shell edge 2-6, the first annular bulge 2-7 can be embedded into the annular groove 1-7, and the first thick spherical shell liquid guide hole 2-1, the second thick spherical shell liquid guide hole 2-2, the third thick spherical shell liquid guide hole 2-3 and the fourth thick spherical shell liquid guide hole 2-4 are the same as the first thin spherical shell edge liquid guide hole 1-1, the second thin spherical shell edge liquid guide hole 1-2, the third thin spherical shell edge liquid guide hole 1-3 and the fourth thin spherical shell edge liquid guide hole 1-4 in size. After the equivalent cerebrospinal fluid solution overflows, the equivalent cerebrospinal fluid solution can be respectively guided to the first thin spherical shell fluid guide hole 1-1, the second thin spherical shell fluid guide hole 1-2, the third thin spherical shell fluid guide hole 1-3 and the fourth thin spherical shell fluid guide hole 1-4 through the first thick spherical shell fluid guide hole 2-1, the second thick spherical shell fluid guide hole 2-2, the third thick spherical shell fluid guide hole 2-3 and the fourth thick spherical shell fluid guide hole 2-4.

Fig. 3A-3F show the design of the special bracket, which is made of nylon material. The special support comprises a base 3, a cross rod 4, a threaded rod 5 and a sliding block 6, and can be used for accurately positioning a bionic head die body, a magnetic field measuring probe and a transcranial magnetic stimulation therapeutic apparatus coil by matching with a high-precision steel ruler.

Referring to fig. 3B, the base 3 is an integral structure formed by cutting a cylindrical acrylic nylon substrate with a diameter of 300mm and a height of 170mm, and has no influence on the measurement of the magnetic field signal. A cylindrical through hole 3-7 with the diameter of 184mm is etched from the center of the upper surface of the base 3. The depth of the cylindrical through hole 3-7 is larger than the radius of the thick spherical shell main body 2-5, and the thick spherical shell main body 2-5 can be accommodated. An annular liquid retaining groove 3-5 with the depth of 10mm and the width of 20mm is etched on the upper surface of the base 3 and is used for containing overflowed cerebrospinal fluid. The annular liquid retention groove 3-5 and the edge of the upper surface of the base 3 form a second annular bulge 3-6 with the width of 20mm. And a positioning line is symmetrically etched at the positions of 0 degree, 90 degrees, 180 degrees and 270 degrees on the side surface of the second annular bulge 3-6. The first round hole array 3-1, the second round hole array 3-2, the third round hole array 3-3 and the fourth round hole array 3-4 are symmetrically etched at 0 degree, 90 degrees, 180 degrees and 270 degrees on the upper surface of the base 3, threads are arranged inside all round holes in each group of round hole arrays, the inner diameters of the round holes are 15mm, and the depths of the round holes are not less than 20mm. The side face of the lower part of the base 3 is provided with a first rectangular through hole 3-8 with the width of 200mm and the height of 50mm, and the first rectangular through hole 3-8 and the cylindrical through hole 3-7 form a communicating structure. The lower edge of the first rectangular through hole 3-8 is 20mm away from the bottom surface of the base 3.

Referring to fig. 3C, a first circular through hole 4-1 and a second circular through hole 4-2 are symmetrically etched on both sides of the cross bar 4, a first side circular through hole 4-3 and a second side circular through hole 4-4 are vertically etched on the side surface of the cross bar 4, the first circular through hole 4-1 is communicated with the first side circular through hole 4-3, and the second circular through hole 4-2 is communicated with the second side circular through hole 4-4. Threads are arranged inside the first side circular through hole 4-3 and the second side circular through hole 4-4. A second rectangular through hole 4-5 with the length of 160mm and the width of 16mm is etched in the middle of the cross rod 4, and the second rectangular through hole 4-5 is used for passing through the magnetic field measuring probe 7. The height of the cross rod 4 can be fixed through the first side circular through hole 4-3 and the first side circular through hole 4-4 by screwing screws.

Referring to FIG. 3D, the threaded shaft 5 comprises two identical first threaded shafts 5-1 and second threaded shafts 5-2, each having a height of 200mm. The bottom of each threaded rod is provided with threads and can be screwed into any one of the first round hole array 3-1, the second round hole array 3-2, the third round hole array 3-3 and the fourth round hole array 3-4; the diameters of the first threaded rod 5-1 and the second threaded rod 5-2 are slightly smaller than the inner diameters of the first round through hole 4-1 and the second round through hole 4-2 on the base.

Referring to fig. 3E and 3F, the slide block 6 is made of a square nylon material, and includes a left slide block 6-1 and a right slide block 6-2 which have the same structure and are symmetrical to each other, and the left slide block 6-1 and the right slide block 6-2 are used for fixing the horizontal position of the measuring probe on the cross bar 4. A first symmetrical through hole 6-3 and a second symmetrical through hole 6-4 are drilled on the rectangular square block at the upper half part of the left sliding block 6-1, and a first through hole 6-7 is drilled on the square block at the lower half part of the left sliding block 6-1; third symmetrical through holes 6-5 and fourth symmetrical through holes 6-6 are drilled at positions, corresponding to the first symmetrical through holes 6-3 and the second symmetrical through holes 6-4, of the rectangular block at the upper half portion of the right sliding block 6-2, second through holes 6-8 are drilled at the lower half portion of the right sliding block 6-2 and are provided with internal threads, and threads are arranged on the inner walls of the first symmetrical through holes 6-3, the second symmetrical through holes 6-4, the third symmetrical through holes 6-6 and the fourth symmetrical through holes 6-7. The left slide block 6-1 and the right slide block 6-2 are assembled together to form a slide block 6, and a top through hole 6-9 is drilled at the top of the slide block 6. The lower half part of the sliding block 6 is provided with a T-shaped through hole 6-10, and the nested cross rod 4 can move on the sliding block 6.

As shown in FIGS. 4A and 4B, the magnetic field measuring probe 7 includes a probe body 7-1 and a protective case7-2, the external diameter of the probe main body 7-1 is 14mm in length, 12mm in width, 50mm in height and 2mm in shell thickness. Three high-precision Hall elements with approximate response speed are arranged in the probe main body 7-1 and comprise two patch type Hall elements H ₁ And H ₂ And a Hall element H ₃ . The 3 Hall elements are distributed in a three-dimensional orthogonal manner in space and are precisely fixed on the probe main body 7-1, wherein the surface mounted Hall element H ₁ Is 8mm away from the inner bottom surface of the probe main body 7-1, and is provided with a chip Hall element H ₂ Is 3mm away from the inner bottom surface of the probe body 7-1, and is directly inserted with a Hall element H ₃ Is 15mm away from the bottom surface of the inner side of the probe body 7-1. A data line of the three-dimensional orthogonal Hall element penetrates out of the upper part of the probe main body 7-1, then penetrates through the protective shell 7-2 and is connected with the device host 9; after the probe body 7-1 is assembled, the probe body 7-1 is filled with resin rubber to realize waterproof sealing of the Hall element and a circuit board thereof, and meanwhile, the protective shell 7-2 is vertically fixed on the upper surface of the probe body 7-1. The width of the probe main body 7-1 is slightly smaller than the second rectangular through hole 4-5, and the outer diameter of the protective shell 7-2 is the same as the inner diameter of the top through hole 6-9 of the sliding block 6.

In addition, a cerebrospinal fluid equivalent solution and a brain gray matter equivalent solution were prepared, sodium chloride, potassium chloride and glucose were added to primary pure water, and the conductivity and the relative permittivity thereof were measured at 2.8kHz, respectively. Wherein the conductivity of the cerebrospinal fluid equivalent solution is 2.01S/m, and the relative dielectric constant is 130; the conductivity of the equivalent solution of the brain gray matter is 0.11S/m, and the relative dielectric constant is 80500.

And secondly, after the bionic head die body and the special support are assembled, the device host 9 is respectively connected with the magnetic field measuring probe 7, the temperature measuring module 8 and the control computer 10 through the data lines 11, and the power supply of each device is started. A stimulating coil of the transcranial magnetic stimulation therapeutic apparatus is inserted into the first rectangular through hole 3-8 on the base 3, and the center of the coil is tightly attached without extruding the thick spherical shell main body 2-5. If not, the stimulation coil can be raised in the first rectangular through hole 3-8 using an acrylic plate of appropriate size.

And thirdly, setting a stimulation sequence of the transcranial magnetic stimulation therapeutic apparatus, operating special equipment for detecting the magnetic field and the temperature of the transcranial magnetic stimulation therapeutic apparatus to acquire and analyze magnetic field signals and temperature signals, and evaluating uncertainty of a measurement result.

In order to better reproduce the content of the present invention, the principles, procedures and results of the magnetic field and temperature measurement described above are briefly described as follows.

The hall effect means that when a current I is introduced into the hall element, an external magnetic field perpendicular to the current direction causes electrons and holes in the semiconductor, which are driven by a voltage to move directionally, to gather in different directions and generate an electric field. When the electric field force applied to the directionally moving particles balances the lorentz force, the electrons and holes are no longer deflected, and the resulting built-in voltage is referred to as the hall voltage U _H It can be expressed as:

wherein d is the thickness of the Hall element, I is the current intensity applied in the conductor, B is the magnetic field intensity, R is _H Is a hall resistor.

According to the formula (1), the magnetic induction B and the Hall voltage U _H The magnetic induction intensity can be calculated through Hall voltage.

The thermoelectric effect refers to a phenomenon in which an electric current or charge is accumulated when electrons (holes) in a heated object migrate from a high temperature region to a low temperature region with a temperature gradient. The magnitude of this effect is embodied in thermal energy (Q), defined as:

where E is the electric field generated by charge accumulation and dT represents the temperature gradient.

According to the formula (2), the temperature gradient generated on both sides of the sensor is linearly related to the potential, and the temperature gradient can be calculated through the potential.

The maximum magnetic induction intensity measurement in the invention means that the output frequency of a stimulation sequence of the transcranial magnetic stimulation therapeutic apparatus is set to be 10Hz, the output intensity is 100%, the stimulation duration is 1s, and the interval time of stimulation clusters is 2s, a magnetic field measuring probe 7 is vertically attached to the surface of a stimulation coil 13 according to the graph 6, the magnetic induction intensities are measured at measuring positions 13-1, 13-2, 13-3 and 13-4 respectively, and each measuring point is repeatedly measured for 6 times.

The measurement of the magnetic induction intensity of the space point in the invention means that the output frequency of a stimulation sequence of the transcranial magnetic stimulation therapeutic apparatus is set to be 10Hz, the output intensity is set to be 100%, the stimulation duration is 1s, and the stimulation cluster interval time is set to be 2s. Measuring points are selected according to the graph 7, the probe body 7-1 is placed at each measuring point in sequence, each measuring point is guaranteed to be 10mm away from the lower surface of the probe body, and the measurement is repeated for 6 times at each measuring point. The measuring points are 19 spatial measuring points of 3 layers in the thin spherical shell main body 1-5, wherein O 'to II' are serial numbers of the layer where the measuring points are located. The layer 0' only contains 1 measuring point, is positioned at the center of the bottom surface in the thin spherical shell main body 1-5, and specifically, the lowest point in the thin spherical shell main body 1-5 is 10mm; the distance between the O 'layer and the I' layer and the height difference between the I 'layer and the II' layer are both 15mm. The layer I 'and the layer II' both contain 9 measuring points, and the plane formed by each layer of measuring points is parallel to the upper surface of the thin spherical shell main body 1-5. Referring to the coordinate axes of fig. 7, the distance difference between the measurement points in each row (y-axis direction) of the i 'layer and the ii' layer is 20mm, and the distance difference between the measurement points in each column (x-axis direction) is 15mm.

Measuring the output frequency means that the output frequency of a stimulation sequence of the transcranial magnetic stimulation therapeutic apparatus is set to be 5Hz and 10Hz, the output intensity is 80%, the stimulation duration is 1s, and the stimulation cluster interval time is 2s; the output frequency of the stimulation sequence is set to be 25Hz, the output intensity is set to be 50%, the stimulation duration is set to be 1s, and the stimulation cluster interval is set to be 2s. Under the above 3 output frequencies, the magnetic field signal at each output frequency was measured at the O' point shown in fig. 7 and calculated to obtain the output frequency measurement result, and the measurement was repeated 6 times at each output frequency.

Measuring the stimulation pulse width refers to setting the output frequency of a stimulation sequence of the transcranial magnetic stimulation therapeutic apparatus to be 5Hz and 10Hz, the output intensity to be 80 percent, the stimulation duration to be 1s and the stimulation cluster interval to be 2s; the output frequency of the stimulation sequence is set to be 25Hz, the output intensity is set to be 50%, the stimulation duration is set to be 1s, and the stimulation cluster interval is set to be 2s. Under the above 3 output frequencies, the magnetic field signal at each output frequency was measured at the O' point shown in fig. 7 and calculated to obtain the stimulation pulse width measurement result, and the measurement was repeated 6 times at each output frequency.

Measuring the surface temperature of the coil refers to setting the output frequency of a stimulation sequence of the transcranial magnetic stimulation therapeutic apparatus to be 10Hz, the output intensity to be 100 percent, the stimulation duration to be 1s and the stimulation cluster interval to be 2s. The temperature measuring module 8 is attached to the measuring positions 13-1, 13-2, 13-3 and 13-4 in a plurality of times according to fig. 6 to measure the coil surface temperature at the positions. Each measurement site consecutively measured 6 stimulation sequences and recorded data.

Through the steps, the measurement results of the maximum magnetic induction intensity, the spatial magnetic field distribution, the output magnetic field frequency, the output magnetic field stimulation pulse width and the coil surface temperature of the transcranial magnetic stimulation therapeutic apparatus are shown in tables 1-6.

TABLE 1 maximum magnetic induction measurements (unit: T) after rejection of outliers

TABLE 2 simulation results of maximum magnetic induction (unit: T)

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As can be seen from tables 1 and 2, the maximum magnetic induction intensity that can be achieved by the surface of the stimulating coil is 2.227T, which is slightly higher than 2.122T obtained by simulation, the deviation between simulation and actual measurement is about 4.71%, the simulation and actual measurement data are well matched, and the detection device can complete the function of measuring the magnetic induction intensity in the space.

TABLE 3 comparison of simulation and measured values of magnetic induction intensity in thin spherical shell main body

According to table 3, the simulation result is similar to the actual measurement result, and the detection device can complete the function of measuring the magnetic induction intensity in the solution.

TABLE 4 output frequency measurement (unit: hz)

According to the table 4, the relative deviation between the measured result of the output frequency of the TMS therapeutic apparatus and the set value is within 0.60%, and the output frequency of the equipment is stable.

TABLE 5 stimulation pulse Width measurement (unit: mus)

According to Table 5, the actual stimulation pulse width of the TMS therapeutic apparatus is unstable, and the stimulation pulse width has no fixed variation trend along with the change of the output frequency. Referring to the technical manual of the transcranial magnetic stimulation treatment instrument, the set value of the stimulation pulse width is 404.56 μ s, and the maximum relative deviation of the measured value of the stimulation pulse width of the device from the set value is 3.32%. The detection device can complete the function of measuring the width of the stimulation pulse.

TABLE 6 measurement results of coil surface temperature (unit:. Degree. C.)

According to table 6, the temperature measuring module can work normally and stably, and the detecting device can realize the function of measuring the surface temperature of the coil in real time.

Further, the uncertainty evaluation method of the measurement results will be described by taking a set of data 2.166t,2.206t,2.186t,2.218t,2.184t and 2.194T in measuring the maximum magnetic induction on the coil surface as an example. Each measurement is an average of 6 measurements.

Step 1: culling outliers

When the magnetic field measurement probe is operated, an outlier is mixed in a measurement result under the influence of mechanical and electrical noise. According to the Dixon rule, the magnetic induction intensity is arranged in an ascending order as B ₁ ,B ₂ ,B ₃ ,…,B ₆ I.e., 2.166T,2.206T,2.186T,2.218T,2.184T, and 2.194T. And calculating a statistic r according to equation (3) ₁₁ And r' ₁₁ 。

Get the solution of r ₁₁ ＝0.2308，r' ₁₁ ＝0.3462。

Empirically, outliers of magnetic induction intensity appear on both sides, and a table lookup yields the threshold value D (α, n) = D (0.025, 6) =0.623 for the dixon criterion. r is a radical of hydrogen ₁₁ ＜r' ₁₁ < D (0.025, 6), this measurement was abnormal-free.

Step 2, measuring standard deviation of magnetic induction intensity

For the magnetic induction intensity value corresponding to each space point, the optimal estimation is the average value of multiple measurements, and is expressed as:

wherein n is the number of independent measurements.

In this measurement, n =6,

measurement of Standard deviation μ (B) _k )＝0.0182T＝18.2mT。

And 3, step 3: uncertainty assessment

Factors that introduce measurement uncertainty during measurement at the reference temperature of 20 ℃ include readings of the magnetic field measuring probe, readings of the straightedge used for length measurement, readings of the temperature sensor, and human operation. The measurement model of magnetic induction can be expressed as:

B＝B _S +δB+B _P +B _T (6)

in the formula: b is _S -a probe-converted magnetic induction measurement;

δ B-Probe resolution;

B _P -magnetic induction bias introduced by positioning accuracy;

B _T -temperature drift induced magnetic induction bias.

According to the measurement model, the influence quantity of the magnetic induction intensity is as follows:

(a) Magnetic induction measurement, B _S

The uncertainty introduced by the repeated measurements (class a uncertainty) is the standard uncertainty: u (B) _S )＝0.0182T＝18.2mT

(b) Resolution of the probe, δ B

The magnetic field measuring probe consists of three-axis Hall elements, the response characteristics of the Hall elements can be obtained by adopting the relation between voltage and a standard magnetic field, and the magnetic field measuring probe is sent to an electromagnetic institute of China metrological scientific research institute for calibration. After the probe collects signals, the voltage at two ends of the Hall element is displayed through the virtual oscilloscope, so that the resolution of the probe is limited by the voltage resolution of the virtual oscilloscope, each channel of the oscilloscope uses an ADC with 8 bits to generate 0-255 bytes, and each unit byte corresponds to 25mT. Assuming it is a rectangular distribution, the standard uncertainty introduced by probe resolution (class B uncertainty) is:

(c) The positioning accuracy introduces magnetic induction deviation, B _p The positioning error is derived from the indication error of the steel ruler, the subjective reading error of human eyes and the coil vibration error caused by alternating current.

Measurement expansion uncertainty U =0.01mm +3 × 10 of 300mm primary precision steel ruler for length measurement in this measurement ^-6 L (k = 2), and the standard uncertainty of the measured length of the straightedge according to the calculation of the extended uncertainty is:

the subjective reading error is 0.5mm and is larger than the indication error of the straight steel ruler, and the positioning error of the probe caused by manual operation is 1mm and is far larger than the subjective reading error and the indication error of the straight steel ruler. According to empirical values, the maximum variation in magnetic induction caused by a 1mm displacement is 257mT. According to experience, the uncertainty of the human operation can be considered to follow a rectangular distribution, and the standard uncertainty (class a uncertainty) introduced by the positioning accuracy is:

(d) Deviation of magnetic induction caused by temperature drift, B _T

From the Hall element performance, the change in magnetic induction intensity due to a temperature change at room temperature (20. + -. 2). Degree.C.was determined. The maximum temperature drift coefficient of a Hall element arranged in the probe is-0.06 thousandth DEG C ^-1 In the range of (0 to 4) T, the maximum magnetic induction drift is 0.96mT. Assuming a rectangular distribution, the standard uncertainty introduced by temperature drift (class B uncertainty) is:

and 4, step 4: correlation determination

Measured by a probeThe uncertainty of multiple measurements and the uncertainty of the converted magnetic induction intensity of the probe have certain correlation with the uncertainty introduced by the resolution of the probe, and a larger value u (B) is taken _S )。

And 5: summary of standard uncertainty

TABLE 7 summary of uncertainty components of magnetic field measurements

Step 6: uncertainty of synthetic standard

By substituting each component into formula (11), the synthetic standard uncertainty can be found as:

and 7: extended uncertainty

The degree of freedom k =2 is chosen, and the extended uncertainty U of this maximum magnetic induction measurement result is then:

compared with the maximum magnetic induction intensity measurement mean value of 2.192T, the expanded uncertainty of 0.300T of the measurement result is only 13 percent of the maximum magnetic induction intensity measurement result. In the field of electromagnetic measurement, the uncertainty of the measurement result is small, and the measurement result is credible.

Although the present invention has been described with reference to a preferred embodiment, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. A special device for detecting the magnetic field and the temperature of a transcranial magnetic stimulation therapeutic apparatus is characterized in that: comprises a bionic head die body, a special bracket, a magnetic field measuring probe (7), a temperature measuring module (8), a device host (9), a control computer (10), a data line (11) and measuring software (12);

the bionic head die body is composed of a thin spherical shell (1) located on the upper layer and a thick spherical shell (2) located on the lower layer, the thin spherical shell (1) and the thick spherical shell (2) are of an integrated structure which is made of a cylindrical acrylic base material through cutting, the bionic head die body is arranged on a base (3), a magnetic field measuring probe (7) is arranged at the top of a sliding block (6) of a special support, a device host (9) is connected with the magnetic field measuring probe (7), a temperature measuring module (8) and a control computer (10) through data lines (11), and measuring software (12) is installed in the control computer (10).

2. The special device for the detection of the magnetic field and the temperature of the transcranial magnetic stimulation treatment instrument according to claim 1, wherein the special device comprises: the thin spherical shell (1) consists of a thin spherical shell main body (1-5) and a thin spherical shell edge (1-6), wherein the thin spherical shell main body (1-5) is a hemisphere with the wall thickness not more than 3mm and the inner diameter of 140-150 mm, a first thin spherical shell liquid guide hole (1-1), a second thin spherical shell liquid guide hole (1-2), a third thin spherical shell liquid guide hole (1-3) and a fourth thin spherical shell liquid guide hole (1-4) are symmetrically etched at the positions of 0 degrees, 90 degrees, 180 degrees and 270 degrees on the lower edge of the thin spherical shell edge (1-6), and an annular groove (1-7) is etched at the position, close to the thin spherical shell main body (1-5), of the lower edge of the thin spherical shell edge (1-6); the thick spherical shell (2) consists of a thick spherical shell main body (2-5) and a thick spherical shell edge (2-6), wherein the thick spherical shell main body (2-5) is a hemispherical shell with the wall thickness not more than 12mm and the inner diameter of 150-165 mm, a first annular bulge (2-7) is arranged above the thick spherical shell edge (2-6) and along the inner edge of the thick spherical shell main body (2-5), a first thick spherical shell liquid guide hole (2-1), a second thick spherical shell liquid guide hole (2-2), a third thick spherical shell liquid guide hole (2-3) and a fourth thick spherical shell liquid guide hole (2-4) are symmetrically etched at the positions of 0 degree, 90 degree, 180 degree and 270 degree of the first annular bulge (2-7) respectively, a positioning line is respectively etched on the side surface of the edge (2-6) of the thick spherical shell and the central positions of the side surface which is opposite to the first thick spherical shell liquid guide hole (2-1), the second thick spherical shell liquid guide hole (2-2), the third thick spherical shell liquid guide hole (2-3) and the fourth thick spherical shell liquid guide hole (2-4), the first annular bulge (2-7) is embedded into the annular groove (1-7), and the first thick spherical shell liquid guide hole (2-1), the second thick spherical shell liquid guide hole (2-2), the third thick spherical shell liquid guide hole (2-3) and the fourth thick spherical shell liquid guide hole (2-4) are connected with the first thin spherical shell liquid guide hole (1-1), the second thin spherical shell liquid guide holes (1-2), the third thin spherical shell liquid guide holes (1-3) and the fourth thin spherical shell liquid guide holes (1-4) are in one-to-one correspondence and have the same diameter.

3. The special device for detecting the magnetic field and the temperature of the transcranial magnetic stimulation treatment instrument according to claim 1, wherein the special device comprises: the special support is made of a nylon base material through cutting, and consists of a base (3), a cross rod (4), a threaded rod (5) and a sliding block (6);

the upper surface of the base (3) is etched inwards to form a cylindrical through hole (3-7), the inner diameter of the cylindrical through hole (3-7) is larger than the outer diameter of the thick spherical shell main body (2-5), the depth of the cylindrical through hole (3-7) is larger than the radius of the thick spherical shell main body (2-5), an annular liquid retaining groove (3-5) is etched on the upper surface of the base (3), a second annular bulge (3-6) is formed between the annular liquid retaining groove (3-5) and the cylindrical through hole (3-7), and a positioning line is symmetrically etched at the positions of 0 degree, 90 degrees, 180 degrees and 270 degrees on the outer side surface of the second annular bulge (3-6) respectively; respectively and symmetrically etching four groups of first round hole arrays (3-1), second round hole arrays (3-2), third round hole arrays (3-3) and fourth round hole arrays (3-4) with the same inner diameter at 0 degrees, 90 degrees, 180 degrees and 270 degrees of the upper surface of the base (3) close to the outer side area, wherein each group of round hole arrays comprises 3 round holes with the same inner diameter and threads inside, and the connecting line distances of the centers of adjacent round holes in each group of round hole arrays are the same; a first rectangular through hole (3-8) is formed in the side face of the lower portion of the base (3), the first rectangular through hole (3-8) and the cylindrical through hole (3-7) form a communicating structure, the width of the first rectangular through hole (3-8) is not smaller than 200mm, the height of the first rectangular through hole (3-8) is not smaller than 50mm, and the distance from the lower edge of the first rectangular through hole (3-8) to the bottom face of the base (3) is not smaller than 20mm; a first circular through hole (4-1) and a second circular through hole (4-2) are symmetrically etched on two sides of the cross rod (4), a first side circular through hole (4-3) and a second side circular through hole (4-4) are vertically etched on the side surface of the cross rod (4), the first circular through hole (4-1) is communicated with the first side circular through hole (4-3), and the second circular through hole (4-2) is communicated with the second side circular through hole (4-4); threads are arranged inside the first side circular through hole (4-3) and the second side circular through hole (4-4), and screws are used for penetrating through the first side circular through hole (4-3) and the second side circular through hole (4-4) and screwing, so that the cross rod (4) is kept at a fixed height on the threaded rod (5); etching a second rectangular through hole (4-5) in the middle of the cross rod (4);

the threaded rod (5) comprises two identical first threaded rods (5-1) and second threaded rods (5-2), the bottom of each threaded rod is provided with threads and can be screwed into any one of the first round hole array (3-1), the second round hole array (3-2), the third round hole array (3-3) and the fourth round hole array (3-4), and the diameters of the tops of the first threaded rods (5-1) and the second threaded rods (5-2) are smaller than the inner diameters of the first round through holes (4-1) and the second round through holes (4-2);

the sliding block (6) consists of a left sliding block (6-1) and a right sliding block (6-2) which have the same structure and are symmetrical to each other, a first symmetrical through hole (6-3) and a second symmetrical through hole (6-4) are drilled on a rectangular block at the upper half part of the left sliding block (6-1), and a first through hole (6-7) is drilled on a rectangular block at the lower half part of the left sliding block (6-1); a third symmetrical through hole (6-5) and a fourth symmetrical through hole (6-6) are arranged at the positions, corresponding to the first symmetrical through hole (6-3) and the second symmetrical through hole (6-4), on the rectangular block at the upper half part of the right sliding block (6-2), a second through hole (6-8) corresponding to the first through hole (6-7) is arranged on the rectangular block at the lower half part of the right sliding block (6-2), and threads are arranged on the inner walls of all four symmetrical through holes, the first through hole (6-7) and the second through hole (6-8);

a top through hole (6-9) is arranged on the upper surface of the left sliding block (6-1) and the right sliding block (6-2) which are assembled into a whole;

the lower half part of the sliding block (6) is provided with a T-shaped through hole (6-10), and the cross rod (4) can be embedded into the upper half part of the T-shaped through hole (6-10);

the upper end of the first threaded rod (5-1) and the upper end of the second threaded rod (5-2) respectively penetrate through the first circular through hole (4-1) and the second circular through hole (4-2), and then plastic screws respectively penetrate through the first side circular through hole (4-3) and the second side circular through hole (4-4) and are screwed tightly, so that the relative positions of the cross rod (4) and the first threaded rod (5-1) as well as the second threaded rod (5-2) are fixed; the lower end of the first threaded rod (5-1) is in threaded connection with any round hole in the first round hole array (3-1), the lower end of the second threaded rod (5-2) is in threaded connection with a round hole in the third round hole array (3-3) in which the round holes connected with the first threaded rod (5-1) are symmetrical, and the circle center connecting line between the round hole connected with the first threaded rod (5-1) and the round hole connected with the second threaded rod (5-2) is parallel to all circle center connecting lines in the second round hole array (3-2) and all circle center connecting lines in the fourth round hole array (3-4); or the lower end of the first threaded rod (5-1) is in threaded connection with any round hole in the second round hole array (3-2), the lower end of the second threaded rod (5-2) is in threaded connection with a round hole in the fourth round hole array (3-4) in a symmetrical manner with the round hole connected with the lower end of the first threaded rod (5-1), and the circle center connecting line between the round hole connected with the first threaded rod (5-1) and the round hole connected with the second threaded rod (5-2) is parallel to all the circle center connecting lines of the round holes in the first round hole array (3-1) and all the circle center connecting lines of the round holes in the third round hole array (3-3).

4. The special device for detecting the magnetic field and the temperature of the transcranial magnetic stimulation treatment instrument according to claim 1 or 3, wherein the special device comprises: the magnetic field measuring probe (7) comprises a probe main body (7-1) and a protective shell (7-2), three high-precision Hall elements are arranged in the probe main body (7-1), the three Hall elements are distributed in a three-dimensional orthogonal manner in space and fixed in the probe main body (7-1) in a cuboid shape, and the Hall elements generate voltage signals after being stimulated by an alternating magnetic field and are calculated by a control computer (10) to obtain magnetic field signals; a data line of the three-dimensional orthogonal Hall element penetrates out of the upper part of the probe main body (7-1), then penetrates through the protective shell (7-2) and is connected with a device host (9); after the probe main body (7-1) is assembled, resin rubber is used for filling the probe main body (7-1) to realize waterproof sealing of the Hall element and a circuit board thereof, and meanwhile, the protective shell (7-2) is vertically fixed on the upper surface of the probe main body (7-1); the diameter of the probe main body (7-1) is smaller than that of the second rectangular through hole (4-5), the outer diameter of the protective shell (7-2) is the same as the inner diameter of the top through hole (6-9), and a positioning line is etched at the upper position of the protective shell (7-2) and used for positioning during assembly of the special support;

the magnetic field measuring probe (7) is arranged in the second rectangular through hole (4-5), the left sliding block (6-1) and the right sliding block (6-2) clamp the protective shell (7-2) and enable a positioning line on the protective shell (7-2) to be aligned with the lower surface of the T-shaped through hole (6-10), and the cross rod (4) is embedded into the upper half part of the T-shaped through hole (6-10);

the plastic screws respectively penetrate through the first symmetrical through hole (6-3), the third symmetrical through hole (6-5), the second symmetrical through hole (6-4) and the fourth symmetrical through hole (6-6) and are fixed through nuts; the plastic screw is in threaded connection with the first through hole (6-7) and the second through hole (6-8) and is screwed tightly, so that the sliding block (6) is fixed on the cross rod (4).

5. The special device for detecting the magnetic field and the temperature of the transcranial magnetic stimulation treatment instrument according to claim 1, wherein the special device comprises: wherein the temperature measuring module (8) comprises a platinum resistance temperature sensor, and signals generated by the sensor are transmitted to the device host (9) through a data line (11); a virtual oscilloscope module is arranged in the device host (9) to realize the processing and storage of voltage signals generated by the Hall element in the probe main body (7-1) and voltage signals generated by the temperature measurement module (9); the control computer (10) controls the data acquisition process and realizes the display, processing and storage of data.

6. Method for using the special device for the detection of the magnetic field and temperature of a transcranial magnetic stimulation treatment instrument according to claims 1-5, wherein: the method comprises the following steps:

step 2: preparing a cerebrospinal fluid equivalent solution and a brain gray matter equivalent solution according to the conductivity and the relative dielectric constant of the cerebrospinal fluid and the brain gray matter of the human body; the cerebrospinal fluid equivalent solution and the brain gray matter equivalent solution are used for forming a detection environment similar to the electromagnetic characteristics of real human brain tissue;

and step 3: assembling a bionic head die body, injecting cerebrospinal fluid equivalent solution and brain gray matter equivalent solution, putting the thick spherical shell (2) into the base (3), and rotating the thick spherical shell (2) to enable the positioning lines of the edges (2-6) of the thick spherical shell to correspond to the positioning lines of the second annular bulges (3-6) one by one; injecting the equivalent cerebrospinal fluid solution into the thick spherical shell (2) until the liquid level reaches one third of the internal height of the thick spherical shell (2), slowly placing the thin spherical shell (1) into the thick spherical shell (2), and enabling the equivalent cerebrospinal fluid solution to flow upwards along the outer wall of the thin spherical shell (1) due to extrusion of the thin spherical shell;

rotating the thin spherical shell (1) to enable a first annular bulge (2-7) to be embedded into the annular groove (1-7), and enabling a first thin spherical shell liquid guide hole (1-1), a second thin spherical shell liquid guide hole (1-2), a third thin spherical shell liquid guide hole (1-3) and a fourth thin spherical shell liquid guide hole (1-4) to be respectively aligned with a first thick spherical shell liquid guide hole (2-1), a second thick spherical shell liquid guide hole (2-2), a third thick spherical shell liquid guide hole (2-3) and a fourth thick spherical shell liquid guide hole (2-4); cerebrospinal fluid equivalent solution exceeding the volume of a gap between the thin spherical shell (1) and the thick spherical shell (2) is discharged through a first thin spherical shell liquid guide hole (1-1), a second thin spherical shell liquid guide hole (1-2), a third thin spherical shell liquid guide hole (1-3), a fourth thin spherical shell liquid guide hole (1-4), a first thick spherical shell liquid guide hole (2-1), a second thick spherical shell liquid guide hole (2-2), a third thick spherical shell liquid guide hole (2-3) and a fourth thick spherical shell liquid guide hole (2-4) and then accumulated in an annular liquid retaining groove (3-5); finally, the equivalent solution of brain gray matter is injected into the shell (1) until the liquid level reaches four fifths of the height inside the shell (1).

And 4, step 4: assembling a special bracket, a magnetic field measuring probe (7) and a temperature measuring module (8), screwing the lower end of a first threaded rod (5-1) into any one round hole of a first round hole array (3-1) and connecting the round holes in a threaded manner, screwing the lower end of a second threaded rod (5-2) into a round hole in a third round hole array (3-3) which is symmetrical to the screwing round hole of the lower end of the first threaded rod (5-1) and connecting the round holes in a threaded manner, wherein circle center connecting lines between the round holes connected with the first threaded rod (5-1) and the round holes connected with the second threaded rod (5-2) are parallel to circle center connecting lines of all round holes in the second round hole array (3-2) and circle center connecting lines of all round holes in a fourth round hole array (3-4); or the lower end of the first threaded rod (5-1) is screwed into any round hole of the second round hole array (3-2) and is in threaded connection, the lower end of the second threaded rod (5-2) is screwed into a round hole of the fourth round hole array (3-4) which is symmetrical to the screwed round hole of the lower end of the first threaded rod (5-1) and is in threaded connection, and at the moment, a circle center connecting line between the round hole connected with the first threaded rod (5-1) and the round hole connected with the second threaded rod (5-2) is parallel to circle center connecting lines of all round holes in the first round hole array (3-1) and circle center connecting lines of all round holes in the third round hole array (3-3);

then, a magnetic field measuring probe (7) penetrates through a second rectangular through hole (4-5), a left sliding block (6-1) and a right sliding block (6-2) are used for clamping a protective shell (7-2) and enabling a positioning line on the protective shell (7-2) to be aligned with the lower surface of a T-shaped through hole (6-10), and meanwhile, a cross rod (4) is embedded into the upper half part of the T-shaped through hole (6-10); respectively penetrating plastic screws through the first symmetrical through hole (6-3), the third symmetrical through hole (6-5), the second symmetrical through hole (6-4) and the fourth symmetrical through hole (6-6), and fixing by using nuts; meanwhile, plastic screws are used to penetrate through the first through holes (6-7) and the first through holes (6-8) and are screwed tightly, and the relative positions of the sliding block (6) and the cross rod (4) are fixed;

integrally inserting the fixed cross rod (4), the fixed slide block (6) and the fixed magnetic field measuring probe (7) into the cerebral gray matter equivalent solution in the thin-sphere shell (1), and enabling the first threaded rod (5-1) and the second threaded rod (5-2) to respectively penetrate through the first round through hole (4-1) and the second round through hole (4-2); adjusting the relative position of a sliding block (6) on a cross rod (4), then adjusting the relative height of the cross rod (4) and a threaded rod (5) to enable a probe main body (7-1) to reach a measuring position, and finally fixing the cross rod (4) on a first threaded rod (5-1) and a second threaded rod (5-2) by respectively penetrating through a first side circular through hole (4-3) and a second side circular through hole (4-4) by using plastic screws; sticking a temperature measuring module (8) on the surface of a stimulating coil of the transcranial magnetic stimulation therapeutic apparatus;

and 5: setting a stimulation sequence of the transcranial magnetic stimulation therapeutic apparatus, starting magnetic field and temperature detection, inserting a stimulation coil of the transcranial magnetic stimulation therapeutic apparatus into the first rectangular through hole (3-8), enabling the center of the stimulation coil to be tightly attached but not extruding the thick-shell thin spherical shell main body (2-5), and if the stimulation coil cannot be tightly attached, inserting an acrylic plate into the first rectangular through hole (3-8) to lift the stimulation coil; and (3) using a repeated pulse stimulation mode, measuring the maximum magnetic induction intensity, the spatial magnetic field distribution, the output frequency, the stimulation pulse width and the coil surface temperature after the probe main body (7-1) reaches the measurement position, and carrying out data analysis and uncertainty evaluation on the measurement result.

7. The method for magnetic field and temperature detection of a transcranial magnetic stimulation treatment instrument according to claim 6, wherein the method comprises the following steps: the method for preparing the cerebrospinal fluid equivalent solution and the brain gray matter equivalent solution is characterized in that primary pure water is used as a basic substance, and the electrical conductivity and the relative dielectric constant of the tissue equivalent solution are adjusted by adding salts and saccharides, so that the electrical conductivity and the relative dielectric constant of the two equivalent solutions are respectively equivalent to real human cerebrospinal fluid and brain gray matter, wherein the electrical conductivity of the real human cerebrospinal fluid is 1.00-2.51S/m, the relative dielectric constant is 109 +/-30, the electrical conductivity of the real human brain gray matter is 0.06-2.47S/m, and the relative dielectric constant is 85600 +/-25000. The relative dielectric constants were measured and calibrated at a frequency of 2.8kHz.

8. The method for magnetic field and temperature detection of a transcranial magnetic stimulation treatment instrument according to claim 6, wherein the method comprises the following steps: the method for selecting the measuring position of the probe body (7-1) in the method step 4 comprises the following steps: introducing numerical models corresponding to the thin spherical shell (1) and the thick spherical shell (2) into analog simulation software, assigning the conductivities and the relative dielectric constants of the thin spherical shell (1) and the thick spherical shell (2) to values corresponding to human skull, assigning the space between the thin spherical shell (1) and the thick spherical shell (2) to the conductivity and the relative dielectric constant of cerebrospinal fluid, and assigning the internal space of the thin spherical shell (1) to the conductivity and the relative dielectric constant of cerebral gray matter; then, the commonly used round stimulating coil and 8-shaped stimulating coil of the transcranial magnetic stimulation therapeutic apparatus are abstractly established into numerical models with geometrical structural characteristics of respective coil radius, turn number and the like, and parameters such as current intensity, current frequency and the like in the numerical model of the stimulating coil are assigned to corresponding numerical values of the stimulating sequence in the step 5 of the claim 6;

calculating and obtaining the magnetic field distribution of the inner space of the thin spherical shell (1) when different stimulating coils are used based on a finite element method; selecting proper measuring positions according to the distribution characteristics of the magnetic field aiming at different stimulating coils, and particularly, when the maximum magnetic induction intensity, the output frequency and the stimulating pulse width of all stimulating coils are measured, placing a probe main body (7-1) at the lowest position of the inner side of a thin spherical shell (1); when the magnetic field distribution in the inner space of the thin spherical shell (1) is measured, proper space position coordinates, namely x coordinates, y coordinates and z coordinates, are selected according to the structures of the first round hole array (3-1), the second round hole array (3-2), the third round hole array (3-3) and the fourth round hole array (3-4) and different magnetic field distribution characteristics of the stimulating coil.

9. The method for magnetic field and temperature sensing of a transcranial magnetic stimulation treatment instrument according to claim 8, wherein the method comprises the steps of: in the space position x coordinate, the y coordinate and the z coordinate, the x coordinate is determined by the structures and the positions of the first circular hole array (3-1), the second circular hole array (3-2), the third circular hole array (3-3) and the fourth circular hole array (3-4), the y coordinate is determined by the relative position of the sliding block (6) and the cross bar (4), and the z coordinate is determined by the depth of the probe main body (7-1) inserted into the thin spherical shell (1).

10. The method for magnetic field and temperature sensing of a transcranial magnetic stimulation treatment instrument according to claim 6, wherein the method comprises the following steps: the method for positioning the measuring position of the probe main body (7-1) in the method step 4 comprises the following steps: before the measuring position is positioned each time, firstly adjusting the relative position of the sliding block (6) on the cross rod (4), using a steel ruler to measure the distance between each of the two side surfaces of the sliding block (6) and the tail end of the cross rod (4) on the same side until the sliding block (6) is positioned at the central position of the cross rod (4), and secondly adjusting the relative height of the cross rod (4) and the threaded rod (5) to ensure that the tail end surface of the protective shell (7-2) is superposed with the plane of the upper surface of the edge (1-6) of the thin spherical shell;

when in positioning, the first threaded rod (5-1) and the second threaded rod (5-2) are screwed into the symmetrical circular hole array corresponding to the base (3) according to the selected measuring position, and the x coordinate is determined; then moving the slide block (6) and measuring the distance between each of the two side surfaces of the slide block and the tail end of the transverse rod (4) on the same side by using a steel ruler until a target y coordinate is reached; and changing the insertion depth of the probe main body (7-1), and measuring the distance between the positioning line on the protective shell (7-2) and the lower surface of the T-shaped through hole (6-10) by using a straight steel ruler until a target z coordinate is reached.

11. The method for magnetic field and temperature sensing of a transcranial magnetic stimulation treatment instrument according to claim 6, wherein the method comprises the following steps: the method comprises the following specific steps of detecting the magnetic field and the temperature in step 4: for any parameter and any measurement position, at least more than 6 times of results are obtained through continuous measurement, and the average value is taken as a final measurement result.

12. The method for magnetic field and temperature sensing of a transcranial magnetic stimulation treatment instrument according to claim 6, wherein the method comprises the following steps: wherein the data analysis and uncertainty assessment in step 5 of the method comprises the steps of:

step 5-1: tracing the straight steel ruler to a national length reference, tracing the magnetic field measuring probe (7) to a national electromagnetic standard, tracing the temperature measuring module (8) to a national temperature reference, and obtaining the accuracy grade, resolution or uncertainty of the equipment;

step 5-3: and (3) evaluating uncertainty of the magnetic field strength measurement result or the temperature measurement result, analyzing the A-type standard uncertainty and the B-type standard uncertainty introduced by the straightedge, the magnetic field measurement probe (7) and the temperature measurement module (8) according to the accuracy grade, the resolution or the uncertainty obtained in the step (5-1), and then analyzing the correlation of the uncertainties and synthesizing the expanded uncertainty so as to evaluate the feasibility degree of the measurement result.