A special device and method for detecting magnetic field and temperature of transcranial magnetic stimulation therapeutic instrument

Abstract

The application relates to a special device and method for detecting the magnetic field and temperature of a transcranial magnetic stimulation therapeutic instrument, wherein the special device comprises a bionic head model, a special support, a magnetic field measuring probe, a temperature measuring module, a device host, a control computer and a data line; the bionic head model 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 connected with the magnetic field measuring probe, the temperature measuring module and the control computer through the data line. The method is characterized in that a bionic head model equivalent to the electromagnetic characteristics of the head is designed, the magnetic field in the space where the model is located and the temperature on the surface of the coil are measured, the magnetic field measurement results are calculated and analyzed, and 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 are obtained. The method is suitable for detecting and calibrating the core parameters in the research and development and clinical use of the transcranial magnetic stimulation therapeutic instrument, and ensures the safety and effectiveness of the transcranial magnetic stimulation therapeutic instrument.

Description

Technical Field

[0001] This invention relates to a special device and method for detecting magnetic fields and temperatures in the field of medical testing instruments, and particularly to a special device and method for detecting magnetic fields and temperatures in a transcranial magnetic stimulation therapy device. Background Technology

[0002] In the late 19th century, the discovery and experimental verification of the magnetophosphene phenomenon pioneered the use of magnetic fields to modulate human neural activity. Subsequently, numerous research teams utilized magnetic fields to conduct stimulation experiments on human muscles, peripheral nerves, and the cerebral cortex, accumulating a wealth of experimental data. In 1985, the first transcranial magnetic stimulation (TMS) device was successfully developed by Barker and colleagues at the Royal Harland Hospital, University of Sheffield, UK. This device uses pulsed magnetic fields to stimulate target nerve cells, generating an induced electric field, thereby altering the nerve cell membrane potential and regulating nerve cell activity. Due to its non-invasive, non-destructive, and easy-to-operate advantages, TMS therapy has been widely used in the diagnosis and treatment of neurological diseases, mental illnesses, rehabilitation therapy, and brain function testing. TMS treatment has shown significant efficacy, particularly for drug-resistant depression and other mental illnesses.

[0003] With increasing work pressure and a faster pace of life, the number of patients with various mental illnesses is constantly rising; for depression alone, the number of adult patients exceeds 60 million. Transcranial magnetic stimulation (rTMS) devices, as proven effective treatments for mental illnesses, are rapidly gaining popularity in hospitals at level two and above. Based on different stimulation sequence designs, rTMS devices are further categorized into single-pulse transcranial magnetic stimulation (STMS) devices, paired-pulse TTMS devices, repetitive transcranial stimulation (RTS) devices, and burst-pulse TTMS devices. Among these, repetitive transcranial magnetic stimulation (rTMS) devices have the widest clinical application and the highest degree of adoption, thus becoming a key focus of medical device regulatory agencies.

[0004] To regulate the production and use of TMS therapy devices, various domestic and international organizations have issued multiple technical standards for this equipment. The European Union issued a new version of the Medical Device Regulation (MDR;REGULATION (EU) 2017 / 745) in 2017, classifying TMS therapy devices as Class B medical devices and requiring manufacturers to register them according to regulations. The US Food and Drug Administration (FDA) classifies TMS therapy devices as Class II medical devices, and its "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems" requires rTMS therapy devices to provide technical data on parameters such as magnetic field characteristics (waveform, timing, pulse width, intensity, etc.), output waveform, magnetic field spatial distribution, and magnetic field intensity gradient during registration. In China, only the pharmaceutical industry standard YY / T 0994—2015 "Magnetic Stimulation Equipment" is used for registration testing of TMS therapy devices. This standard only specifies the accuracy of parameters such as magnetic induction intensity, output frequency, stimulation pulse width, and timing, but does not specify specific testing methods.

[0005] Based on the aforementioned domestic and international standards, domestic standards focus more on quality control during equipment manufacturing and registration inspection. However, there is a lack of available testing equipment and dedicated methods for assessing the clinical safety and stimulation accuracy of TMS therapeutic devices, especially rTMS therapeutic devices. In clinical use, TMS therapeutic devices use extremely high currents to generate strong magnetic fields (above 1T), which directly act on the human brain to produce an induced electric field. If the stimulation intensity is too high, it may induce transient brain dysfunction such as epilepsy; conversely, if the stimulation intensity is too low, it will not achieve the therapeutic effect and will increase the patient's ineffective electromagnetic exposure. Therefore, it is necessary to test and evaluate the stimulation safety and accuracy of TMS therapeutic devices during clinical use to ensure the safety and reliability of TMS therapy.

[0006] According to Faraday's law of electromagnetic induction, a changing electric current generates an alternating magnetic field, which induces an electric field within matter. Therefore, when a TMS (Transcranial Doppler) therapy device is used, it generates both a magnetic field and an electric field sequentially in the target area of ​​the human brain. The characteristics of the electric field are closely related to the characteristics of brain tissue; different individuals experience different electric fields after TMS stimulation. Furthermore, measuring the electric field intensity in tissue requires a dedicated antenna, which is costly and difficult to achieve. In contrast, the characteristics of the alternating magnetic field generated by a TMS therapy device are primarily determined by the device's performance. The magnetic field transmission is only affected by the object's structure and the propagation distance, and magnetic field strength measurement technology is mature and inexpensive. Therefore, based on existing domestic and international standards and published academic papers, the evaluation of the safety and accuracy of clinical use of TMS therapy devices mainly focuses on the characteristics of the generated magnetic field and the changes in coil surface temperature during magnetic stimulation. Currently, the main method for detecting the magnetic field generated by TMS therapy devices involves using simulation technology to establish a numerical model of the stimulation coil of the TMS therapy device and assign current parameters. Then, methods such as finite element analysis are used to obtain the spatial distribution of the magnetic field generated by the stimulation coil. A teslameter is used to measure the magnetic induction intensity on the surface of the stimulation coil, and the results are compared with the simulation results to verify the accuracy of the simulation. However, this method relies primarily on simulation with supplementary experimental verification, which has two significant drawbacks.

[0007] First, there is a lack of necessary testing phantoms. The magnetic field generated by the TMS therapy device directly affects the human brain. Although theoretically, the magnetic field does not suffer loss when passing through different substances during spatial transmission, to ensure that the simulation results are as close as possible to the actual stimulation, a numerical model of the bionic head phantom should be established, and the electromagnetic field distribution inside the phantom should be obtained. In addition, the testing method should primarily rely on measured data, supplemented by simulation. By developing a bionic head phantom with equivalence to the human head, the magnetic field characteristics of the TMS therapy device can be evaluated by actually measuring the magnetic field strength at typical locations in the simulated head phantom. The equivalence of the bionic head phantom mainly examines structural equivalence and electromagnetic characteristic parameter equivalence, but currently, there are no mature products in the commercial phantom market suitable for testing TMS therapy devices.

[0008] Second, there is a lack of usable magnetic field measurement probes. The pulse width of the damping current generated in the stimulation coil of the TMS therapy device is approximately 400 μs, and the frequency of the alternating magnetic field excited by the damping current is approximately 2.8 kHz. According to the Nyquist sampling theorem, to ensure that the acquired magnetic field signal is not distorted, the sampling frequency of the magnetic field measurement probe should be at least 6 kHz. Furthermore, according to simulation results, different TMS therapy devices...

[0009] The instantaneous value of the alternating magnetic field strength generated on the surface of the stimulation coil can reach 4T. In order to measure the magnetic field strength on the surface of the coil, the magnetic field measurement probe must have a range of at least 0~4T and be able to achieve three-dimensional orthogonal magnetic field strength data acquisition and analysis. At present, there are almost no commercially available teslameters that can simultaneously meet the requirements of triaxial measurement, 6kHz sampling frequency and 0~4T measurement range. The few available products also require customized development according to the detection requirements, which is costly.

[0010] In view of the shortcomings of the existing technology, the inventors, through continuous research, design, and repeated trials and improvements, have finally created this invention with practical value. Summary of the Invention

[0011] The main objective of this invention is to provide a new specialized device and method for detecting the magnetic field and temperature of a transcranial magnetic stimulation (TMS) therapy device. The technical problem to be solved is to develop a biomimetic head model with human head equivalence and to develop a triaxial magnetic field measurement probe with high sampling frequency and wide range. This enables the detection of characteristic parameters such as the maximum magnetic induction intensity, spatial magnetic field distribution, output frequency, stimulation pulse width, and coil surface temperature of the alternating magnetic field generated by the TMS therapy device. By evaluating the uncertainty of the detection results, the accuracy and reliability of the detection results are improved and guaranteed, thus ensuring the safety and effectiveness of the TMS therapy device.

[0012] The objective of this invention and the technical problem it solves are achieved by the following technical solution. According to this invention, a dedicated device for detecting the magnetic field and temperature of a transcranial magnetic stimulation therapy instrument includes a bionic head phantom, a dedicated support, a magnetic field measuring probe, a temperature measuring module, a main unit, a control computer, a data cable, and measurement software.

[0013] The bionic head model consists of a thin spherical shell on the upper layer and a thick spherical shell on the lower layer. The thin and thick spherical shells are integral structures made of cylindrical acrylic substrates and cut by cutting. The bionic head model is set on the base, and the magnetic field measuring probe is set on the top of the slider of the special bracket. The main unit of the device is connected to the magnetic field measuring probe, the temperature measuring module and the control computer through data cables. The measurement software is installed in the control computer.

[0014] Furthermore, the thin spherical shell is composed of a thin spherical shell body and a thin spherical shell edge. The thin spherical shell body is a hemisphere with a wall thickness not exceeding 3 mm and an inner diameter of 140-150 mm. A first, second, third, and fourth thin spherical shell liquid guiding hole are symmetrically etched at positions of 0°, 90°, 180°, and 270° on the lower edge of the thin spherical shell edge, respectively. An annular groove is etched on the lower edge of the thin spherical shell edge near the thin spherical shell body. The thick spherical shell is composed of a thick spherical shell body and a thick spherical shell edge. The thick spherical shell body is a hemispherical shell with a wall thickness not exceeding 12 mm and an inner diameter of 150-165 mm. A first annular protrusion is provided above the edge of the thick spherical shell body, along the inner edge of the body. First, second, third, and fourth thick spherical shell liquid guiding holes are symmetrically etched at 0°, 90°, 180°, and 270° positions on the first annular protrusion, respectively. The thick spherical shell is located on the side of its edge, directly opposite the first, second, third, and fourth thick spherical shell liquid guiding holes.

[0015] A positioning line is etched at each of the core positions. The first annular protrusion is embedded in the annular groove. The first thick spherical liquid guiding hole, the second thick spherical liquid guiding hole, the third thick spherical liquid guiding hole and the fourth thick spherical liquid guiding hole correspond one-to-one with the first thin spherical liquid guiding hole, the second thin spherical liquid guiding hole, the third thin spherical liquid guiding hole and the fourth thin spherical liquid guiding hole and have the same diameter.

[0016] Furthermore, the special bracket is made of nylon substrate and is formed by cutting. The special bracket consists of a base, a crossbar, a threaded rod and a slider.

[0017] The upper surface of the base is etched inward 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 body, and the depth of the cylindrical through hole is larger than the radius of the thick spherical shell body. An annular liquid retention groove is etched on the upper surface of the base. The remaining portion between the annular liquid retention groove and the cylindrical through hole forms a second annular protrusion. A positioning line is symmetrically etched at 0°, 90°, 180°, and 270° on the outer surface of the second annular protrusion. At 0°, 90°, 180°, and 270° on the upper surface of the base near the outer region, four sets of first, second, third, and fourth circular hole arrays with the same inner diameter are symmetrically etched. Each set of circular hole arrays contains three circular holes with the same inner diameter and internal threads. The distance between the centers of adjacent circular holes in each set of circular hole arrays is... The following are the characteristics of the crossbar: A first rectangular through-hole is formed on the lower side of the base, connecting with a cylindrical through-hole. The width of the first rectangular through-hole is not less than 200mm, and its height is not less than 50mm. The lower edge of the first rectangular through-hole is at least 20mm from the bottom surface of the base. A first circular through-hole and a second circular through-hole are symmetrically etched on both sides of the crossbar. A first side circular through-hole and a second side circular through-hole are vertically etched on the side of the crossbar. The first circular through-hole connects with the first side circular through-hole, and the second circular through-hole connects with the second side circular through-hole. The first and second side circular through-holes are threaded internally. A screw is passed through the first and second side circular through-holes and tightened to maintain the crossbar at a fixed height on the threaded rod. A second rectangular through-hole is etched in the middle of the crossbar.

[0018] The threaded rod includes two identical first threaded rods and second threaded rods. Each threaded rod has a thread at its bottom and can be screwed into any one of the first, second, third, and fourth circular hole arrays. The top diameter of the first and second threaded rods is smaller than the inner diameter of the first and second through holes.

[0019] The slider consists of a left slider and a right slider with the same structure and symmetrical to each other. A first symmetrical through hole and a second symmetrical through hole are drilled on the rectangular block of the upper half of the left slider, and a first through hole is drilled on the square block of the lower half of the left slider. A third symmetrical through hole and a fourth symmetrical through hole are provided on the rectangular block of the upper half of the right slider at positions corresponding to the first symmetrical through hole and the second symmetrical through hole. A second through hole corresponding to the first through hole is provided on the square block of the lower half of the right slider. The inner walls of all four symmetrical through holes and the first and second through holes are threaded.

[0020] A top through hole is provided on the upper surface where the left and right sliders are assembled as one piece;

[0021] The lower half of the slider is provided with a T-shaped through hole, and the crossbar can be inserted into the upper half of the T-shaped through hole;

[0022] The upper ends of the first threaded rod and the second threaded rod respectively pass through the first through hole and the second through hole.

[0023] Holes are drilled, and then plastic screws are passed through the first and second side through holes respectively and tightened to fix the relative positions of the crossbar and the first and second threaded rods. The lower end of the first threaded rod is threaded to any one of the holes in the first circular hole array, and the lower end of the second threaded rod is threaded to a hole in the third circular hole array that is symmetrical to the hole connected to the first threaded rod. At this time, the line connecting the centers of the holes connected to the first and second threaded rods is parallel to the line connecting the centers of all the holes in the second and fourth circular hole arrays. Alternatively, the lower end of the first threaded rod is threaded to any one of the holes in the second circular hole array, and the lower end of the second threaded rod is threaded to a hole in the fourth circular hole array that is symmetrical to the hole connected to the lower end of the first threaded rod. At this time, the line connecting the centers of the holes connected to the first and second threaded rods is parallel to the line connecting the centers of all the holes in the first and third circular hole arrays.

[0024] Furthermore, the magnetic field measurement probe includes a probe body and a protective shell. Three high-precision Hall elements are built into the probe body, arranged in a three-dimensional orthogonal pattern and fixed within the cuboid-shaped probe body. The Hall elements generate voltage signals after being stimulated by an alternating magnetic field, and the resulting magnetic field signals are calculated by a control computer. Data lines from the three-dimensional orthogonal Hall elements pass through the top of the probe body, then through the protective shell, and connect to the main unit of the device. After the probe body is assembled, resin rubber is used to infuse the probe body to achieve a waterproof seal for the Hall elements and their circuit boards. Simultaneously, the protective shell is vertically fixed to the upper surface of the probe body. The diameter of the probe body is smaller than the second rectangular through-hole, and the outer diameter of the protective shell is the same as the inner diameter of the top through-hole. Positioning lines are etched on the top of the protective shell for positioning during the assembly of the dedicated bracket.

[0025] The magnetic field measuring probe is installed in the second rectangular through hole. The left and right sliders clamp the protective shell and align the positioning line on the protective shell with the lower surface of the T-shaped through hole. The crossbar is embedded in the upper part of the T-shaped through hole.

[0026] The plastic screws pass through the first symmetrical through hole, the third symmetrical through hole, the second symmetrical through hole, and the fourth symmetrical through hole respectively, and are fixed by nuts; the plastic screws are threadedly connected to the first through hole and tightened to fix the slider to the crossbar.

[0027] Furthermore, the temperature measurement module includes a platinum resistance temperature sensor, and the signal generated by the sensor is transmitted to the device host via a data line; the device host has a built-in virtual oscilloscope module to process and store the voltage signal generated by the Hall element in the probe body and the voltage signal generated by the temperature measurement module; the control computer controls the data acquisition process and realizes the display, processing and storage of data.

[0028] A method for using a dedicated device for detecting the magnetic field and temperature of a transcranial magnetic stimulation (TMS) therapy instrument includes the following steps:

[0029] Step 1: Design and fabricate a bionic head phantom, whose structure and geometric dimensions are close to those of a real human head; the bionic head phantom is used to form a physiological structure similar to that of a real human head.

[0030] Step 2: Based on the conductivity and relative permittivity of human cerebrospinal fluid and cerebral gray matter, prepare equivalent solutions for cerebrospinal fluid and cerebral gray matter; these solutions are used to create a detection environment similar to the electromagnetic properties of real human brain tissue.

[0031] Step 3: Assemble the bionic head model and inject cerebrospinal fluid equivalent solution and cerebral gray matter equivalent solution. Place the thick spherical shell into the base and rotate the thick spherical shell so that the positioning lines on the edge of the thick spherical shell correspond one-to-one with the positioning lines of the second annular protrusion. Inject the cerebrospinal fluid equivalent solution into the thick spherical shell until the liquid level reaches one-third of the internal height of the thick spherical shell. Then, slowly place the thin spherical shell into the thick spherical shell. The cerebrospinal fluid equivalent solution flows upward along its outer wall due to the pressure of the thin spherical shell.

[0032] Rotating the thin spherical shell causes the first annular protrusion to embed into the annular groove, aligning the first, second, third, and fourth thin spherical shell liquid guiding holes with the first, second, third, and fourth thick spherical shell liquid guiding holes, respectively. Cerebrospinal fluid equivalent solution exceeding the volume of the gap between the thin and thick spherical shells is discharged through the first, second, third, and fourth thin spherical shell liquid guiding holes, as well as the first, second, third, and fourth thick spherical shell liquid guiding holes, and then accumulates in the annular retention tank. Finally, the equivalent solution of cerebral gray matter is injected into the thin spherical shell until the liquid level reaches four-fifths of the internal height of the thin spherical shell.

[0033] Step 4: Assemble the special bracket, magnetic field measuring probe, and temperature measuring module. Screw the lower end of the first threaded rod into any one of the holes in the first circular hole array and connect them threadedly. Screw the lower end of the second threaded rod into a hole in the third circular hole array that is symmetrical to the hole into which the lower end of the first threaded rod is screwed, and connect them threadedly. At this time, the line connecting the centers of the holes connected by the first and second threaded rods is parallel to the line connecting the centers of all the holes in the second and fourth circular hole arrays. Alternatively, screw the lower end of the first threaded rod into any one of the holes in the second circular hole array and connect them threadedly. Screw the lower end of the second threaded rod into a hole in the fourth circular hole array that is symmetrical to the hole into which the lower end of the first threaded rod is screwed, and connect them threadedly. At this time, the line connecting the centers of the holes connected by the first and second threaded rods is parallel to the line connecting the centers of all the holes in the first and third circular hole arrays.

[0034] Then, the magnetic field measuring probe is passed through the second rectangular through hole, and the left and right sliders are used to clamp the protective shell so that the positioning line on the protective shell is aligned with the lower surface of the T-shaped through hole, while the crossbar is inserted into the upper part of the T-shaped through hole; plastic screws are passed through the first symmetrical through hole, the third symmetrical through hole, the second symmetrical through hole, and the fourth symmetrical through hole respectively, and fixed with nuts; at the same time, plastic screws are passed through the first through hole and the second through hole and tightened to fix the relative position of the slider and the crossbar;

[0035] The fixed crossbar, slider, and magnetic field measuring probe are inserted as a whole into the brain gray matter equivalent solution in the thin spherical shell, so that the first threaded rod and the second threaded rod pass through the first and second through holes, respectively; the relative position of the slider on the crossbar is adjusted, and then the relative height of the crossbar and the threaded rod is adjusted so that the probe body reaches the measuring position; finally, plastic screws are used to fix the crossbar to the first and second threaded rods through the first and second side through holes, respectively; the temperature measuring module is attached to the surface of the stimulation coil of the transcranial magnetic stimulation therapy device.

[0036] Step 5: Set the stimulation sequence of the transcranial magnetic stimulation (TMS) device, start magnetic field and temperature detection, insert the stimulation coil of the TMS device into the first rectangular through hole and ensure the center of the stimulation coil is in close contact with the ground.

[0037] Without squeezing the thick spherical shell body, if it cannot fit tightly, insert an acrylic plate into the first rectangular through hole to raise the stimulation coil; using the repetitive pulse stimulation mode, after the probe body reaches the measurement position, measure the maximum magnetic induction intensity, spatial magnetic field distribution, output frequency, stimulation pulse width and coil surface temperature, and perform data analysis and uncertainty assessment on the measurement results.

[0038] Furthermore, the method for preparing the equivalent solutions of cerebrospinal fluid and cerebral gray matter uses pure water as the base material. Salts and sugars are added to adjust the conductivity and relative permittivity of the tissue equivalent solutions, making the conductivity and relative permittivity of the two equivalent solutions equivalent to those of real human cerebrospinal fluid and cerebral gray matter, respectively. Specifically, the conductivity of real human cerebrospinal fluid is 1.00–2.51 S / m, and the relative permittivity is 109 ± 30; the conductivity of real human cerebral gray matter is 0.06–2.47 S / m, and the relative permittivity is 85600 ± 25000. All relative permittivity values ​​were measured and calibrated at a frequency of 2.8 kHz.

[0039] Furthermore, the method for selecting the measurement position of the probe body in step 4 is as follows: the numerical models corresponding to the thin and thick spherical shells are imported into the simulation software, the conductivity and relative permittivity of the thin and thick spherical shells are assigned to the corresponding values ​​of the human skull, the space between the thin and thick spherical shells is assigned to the conductivity and relative permittivity of the cerebrospinal fluid, and the space inside the thin spherical shell is assigned to the conductivity and relative permittivity of the gray matter of the brain; then, the circular stimulation coil and figure-eight stimulation coil commonly used in transcranial magnetic stimulation therapy devices are abstracted into numerical models with their respective coil radius, number of turns and other geometric structural features, and the parameters such as current intensity and current frequency in the numerical model of the stimulation coil are assigned to the corresponding values ​​of the stimulation sequence in step 5;

[0040] The magnetic field distribution inside the thin spherical shell is calculated using the finite element method when using different stimulation coils. For different stimulation coils, it is necessary to select appropriate measurement positions according to the magnetic field distribution characteristics. Specifically, when measuring the maximum magnetic induction intensity, output frequency, and stimulation pulse width of all stimulation coils, the probe body should be placed at the lowest position inside the thin spherical shell. When measuring the magnetic field distribution inside the thin spherical shell, appropriate spatial coordinates, i.e., x-coordinate, y-coordinate, and z-coordinate, should be selected according to the structure of the first, second, third, and fourth circular hole arrays and the magnetic field distribution characteristics of different stimulation coils.

[0041] Furthermore, in the aforementioned spatial position x-coordinate, y-coordinate, and z-coordinate, the x-coordinate is determined by the structure and position of the first, second, third, and fourth circular hole arrays, the y-coordinate is determined by the relative position of the slider and the crossbar, and the z-coordinate is determined by the depth to which the probe body is inserted into the thin spherical shell.

[0042] Furthermore, the method for positioning the probe body measurement position in step 4 of the method is as follows: before each positioning of the measurement position, first adjust the relative position of the slider on the crossbar, use a steel ruler to measure the distance between each side of the slider and the end of the crossbar on the same side, until the slider is in the center position of the crossbar, then adjust the relative height of the crossbar and the threaded rod so that the end surface of the protective shell coincides with the plane of the upper surface of the thin spherical shell edge.

[0043] During positioning, screw the first and second threaded rods into the base according to the selected measurement position.

[0044] In the symmetrical array of circular holes, determine the x-coordinate; then move the slider and use a steel ruler to measure the distance between each of its two sides and the end of the crossbar on the same side until the target y-coordinate is reached; change the insertion depth of the probe body and use a steel ruler to measure the distance between the positioning line on the protective shell and the lower surface of the T-shaped through hole until the target z-coordinate is reached.

[0045] Furthermore, the method is characterized in that: the specific steps for detecting the magnetic field and temperature in step 4 include: for any parameter and any measurement position, at least 6 consecutive measurements should be taken to obtain the results, and the average value should be taken as the final measurement result.

[0046] Furthermore, the data analysis and uncertainty assessment in step 5 of the method includes the following steps:

[0047] Step 5-1: Trace the steel ruler to the national length standard, trace the magnetic field measuring probe to the national electromagnetic standard, and trace the temperature measuring module to the national temperature standard to obtain the accuracy class, resolution, or uncertainty of the above equipment.

[0048] Step 5-2: For the obtained magnetic field strength measurement results or temperature measurement results, outliers are removed according to the Dickson criterion, and the standard deviation of the evaluated parameter is calculated based on the number of measurements.

[0049] Step 5-3: Evaluate the uncertainty of the magnetic field strength measurement results or temperature measurement results. Based on the accuracy class, resolution or uncertainty obtained in Step 5-1, analyze the Type A standard uncertainty and Type B standard uncertainty introduced by the steel ruler, magnetic field measurement probe, temperature measurement module, etc. Then analyze the correlation of the above types of uncertainty and synthesize the expanded uncertainty to evaluate the reliability of the measurement results.

[0050] This invention has significant advantages and beneficial effects compared with the prior art. It has at least the following advantages:

[0051] 1. The bionic head phantom developed in this invention has a double-shell structure. The thick shell is used to simulate the human skull, and the thin shell is used to separate the equivalent solution of cerebrospinal fluid and the equivalent solution of cerebral gray matter. The sum of the thicknesses of the thick and thin shells is similar to the thickness of the human skull, the width of the gap between the thick and thin shells is similar to the thickness of the human cerebrospinal fluid layer, and the inner diameter of the thin shell is similar to the size of the human cerebral gray matter. The bionic head phantom structure formed by the thick and thin shells is similar to the structure of the human head. This phantom can approximate the real situation of the human head in terms of structural morphology.

[0052] 2. The bionic head phantom developed in this invention is made of acrylic material, and its bioelectromagnetic properties are similar to those of human bones. The conductivity and dielectric constant of the cerebrospinal fluid equivalent solution and the cerebral gray matter equivalent solution perfused in the bionic head phantom are equivalent to those of the corresponding human tissues. Since the dielectric constant measurement results are related to the frequency of the electromagnetic field environment in which the tissue equivalent solution is applied, the above-mentioned dielectric constant measurements of the solution were all performed at the alternating magnetic field frequency of 2.8 kHz commonly used in TMS therapy instruments.

[0053] 3. The magnetic field measurement probe developed in this invention is a triaxial orthogonal measurement probe developed at the component level (Hall element), capable of measuring alternating magnetic field strength. Since the alternating magnetic field frequency commonly used in TMS therapy devices is 2.8kHz, according to the Nyquist sampling theorem, the magnetic field measurement probe developed in this invention has a sampling frequency of 10kHz, a measurement range covering (0~4)T, and a measurement resolution of 25mT, ensuring...

[0054] The acquired stimulus sequence waveforms are not distorted.

[0055] 4. This invention uses a simulation method to determine the measurement position. The numerical models of the bionic head phantom and the stimulation coil are imported into the simulation software. The bionic head phantom, the internal space of the phantom, and the stimulation coil are assigned their corresponding electromagnetic characteristic parameters or current parameters. Then, the magnetic field distribution inside the bionic head phantom is calculated using the finite element method. The measurement position is selected and determined based on the magnetic field distribution. This measurement position selection method selects the measurement position based on the internal magnetic field distribution of the bionic head phantom, which can select a suitable measurement position according to different measurement purposes. At the same time, the coordinates of the measurement position can also guide the positioning of the measurement probe and ensure that the measurement probe is placed in the target position.

[0056] 5. This invention traces the length measurement results of the steel ruler to the national length standard, the magnetic field measurement results of the magnetic field measuring probe to the national electromagnetic standard, and the temperature measurement module to the national temperature standard, thereby obtaining the uncertainties corresponding to the above three types of measurement results; it evaluates the uncertainties of the magnetic field strength measurement results and temperature measurement results, analyzes the Type A standard uncertainty and Type B standard uncertainty, and finally synthesizes the expanded uncertainty to evaluate the reliability of the measurement results.

[0057] The above description is merely an overview of the technical solution of the present invention. In order to better understand the technical means of the present invention and to implement it in accordance with the contents of the specification, the preferred embodiments of the present invention are described in detail below with reference to the accompanying drawings. Attached Figure Description

[0058] Figure 1 : Schematic diagram of the structure of the special equipment for detecting magnetic field and temperature in the transcranial magnetic stimulation therapy device of the present invention.

[0059] Figure 2A : Schematic diagram of the bionic head phantom structure of this invention.

[0060] Figure 2B : Schematic diagram of the thin spherical shell structure of the bionic head phantom of this invention.

[0061] Figure 2C : Schematic diagram of the thick spherical shell structure of the bionic head model of the present invention.

[0062] Figure 3A : Schematic diagram of the special support structure of the present invention.

[0063] Figure 3B : Schematic diagram of the base structure of the special bracket of the present invention.

[0064] Figure 3C Schematic diagram of the crossbar structure of the special bracket of this invention

[0065] Figure 3D : Schematic diagram of the threaded rod structure of the special bracket of the present invention.

[0066] Figure 3E : A schematic diagram of the slider structure of the special bracket of the present invention from the left side.

[0067] Figure 3F : Right side view of the slider structure of the special bracket of the present invention.

[0068] Figure 4A : Schematic diagram of the magnetic field measurement probe structure of the present invention.

[0069] Figure 4B : Schematic diagram of the internal structure of the magnetic field measuring probe of the present invention.

[0070] Figure 5 : Schematic diagram of the measurement software of this invention.

[0071] Figure 6 : Schematic diagram of the measurement position of the maximum magnetic induction intensity and coil surface temperature in this invention.

[0072] Figure 7 : Schematic diagram of the spatial magnetic field distribution measurement points of this invention.

[0073] Explanation of icon numbers

[0074] 1: Thin spherical shell

[0075] 1-1: First thin spherical shell liquid guiding hole; 1-2: Second thin spherical shell liquid guiding hole

[0076] 1-3: Third thin-shell liquid guiding hole; 1-4: Fourth thin-shell liquid guiding hole

[0077] 1-5: Thin spherical shell body; 1-6: Thin spherical shell edge

[0078] 1-7: Annular groove

[0079] 2: Thick spherical shell

[0080] 2-1: First thick spherical shell liquid guiding hole; 2-2: Second thick spherical shell liquid guiding hole.

[0081] 2-3: Liquid guiding hole of the third thick spherical shell 2-4: Liquid guiding hole of the fourth thick spherical shell

[0082] 2-5: Thick spherical shell body; 2-6: Thick spherical shell edge

[0083] 2-7: First annular protrusion

[0084] 3: Base

[0085] 3-1: First circular hole array; 3-2: Second circular hole array

[0086] 3-3: Third circular hole array; 3-4: Fourth circular hole array

[0087] 3-5: Annular liquid retention groove; 3-6: Second annular protrusion

[0088] 3-7: Cylindrical through hole; 3-8: First rectangular through hole

[0089] 4: Crossbar

[0090] 4-1: First through hole; 4-2: Second through hole

[0091] 4-3: First side through hole; 4-4: Second side through hole

[0092] 4-5: Second rectangular through hole

[0093] 5: Threaded rod

[0094] 5-1: First threaded rod 5-2: Second threaded rod

[0095] 6: Slider

[0096] 6-1: Left slider 6-2: Right slider

[0097] 6-3: First symmetrical through hole; 6-4: Second symmetrical through hole

[0098] 6-5: Third symmetrical through hole; 6-6: Fourth symmetrical through hole

[0099] 6-7: First through hole; 6-8: Second through hole

[0100] 6-9: Top through hole; 6-10: T-shaped through hole

[0101] 7: Magnetic field measuring probe

[0102] 7-1: Probe body 7-2: Protective housing

[0103] 8: Temperature measurement module; 9: Main unit

[0104] 10: Control computer 11: Data cable

[0105] 12: Measurement software

[0106] 12-1: Magnetic field measurement window; 12-2: Temperature measurement window

[0107] 13: Stimulation coil

[0108] 13-1: Measurement position 1 13-2: Measurement position 2

[0109] 13-3: Measurement position 3 13-4: Measurement position 4 Detailed Implementation

[0110] To further illustrate the technical means and effects adopted by the present invention to achieve the intended purpose, the following, in conjunction with the accompanying drawings and preferred embodiments, details the specific implementation, methods, steps, features, and effects of a special device and method for detecting the magnetic field and temperature of a transcranial magnetic stimulation therapy device according to the present invention.

[0111] See Figure 1 As shown, a specialized device for detecting the magnetic field and temperature of a transcranial magnetic stimulation (TMS) therapy device according to a preferred embodiment of the present invention includes a bionic head phantom, a specialized support, a magnetic field measuring probe 7, a temperature measuring module 8, a device host 9, a control computer 10, a data cable 11, and measurement software 12. The bionic head phantom is mounted on the base 3 of the specialized support, and the magnetic field measuring probe 7 is mounted on the top of the slider 6 of the specialized support. The device host 9 is connected to the magnetic field measuring probe 7, the temperature measuring module 8, and the control computer 10 via the data cable 11. The temperature measuring module 8 includes a platinum resistance temperature sensor, and the signal generated by the temperature sensor is transmitted to the device host 9 via the data cable 11. The device host 9 has a built-in virtual oscilloscope module to process and store the voltage signals generated by the Hall element in the probe body 7-1 and the voltage signals generated by the temperature measuring module 8. The control computer 10 controls the data acquisition process and displays, processes, and saves the data. The measurement software 12 is installed in the control computer 10 and has a magnetic field measurement window 12-1 and a temperature measurement window 12-2, as shown below. Figure 5 As shown.

[0112] See Figure 2A As shown, the bionic head model consists of a thin spherical shell 1 and a thick spherical shell 2. The thin spherical shell 1 and the thick spherical shell 2 are integral structures made of cylindrical acrylic substrate and cut together.

[0113] See Figure 2B As shown, the thin spherical shell 1 is composed of a thin spherical shell body 1-5 and a thin spherical shell edge 1-6. The thin spherical shell body 1-5 is a hemisphere with a wall thickness of no more than 3 mm and an inner diameter of 140~150 mm. The first thin spherical shell liquid guiding hole 1-1, the second thin spherical shell liquid guiding hole 1-2, the third thin spherical shell liquid guiding hole 1-3 and the fourth thin spherical shell liquid guiding hole 1-4 are symmetrically etched at the 0°, 90°, 180° and 270° positions on the lower edge of the thin spherical shell edge 1-6. The annular groove 1-7 is etched on the lower edge of the thin spherical shell edge 1-6 near the thin spherical shell body 1-5.

[0114] See Figure 2C As shown, the thick spherical shell 2 is composed of a thick spherical shell body 2-5 and a thick spherical shell edge 2-6. The thick spherical shell body 2-5 is a hemisphere with a wall thickness not exceeding 12 mm and an inner diameter of 150-165 mm. Above the thick spherical shell edge 2-6, along the inner edge of the thick spherical shell body 2-5, a first annular protrusion 2-7 is provided. A first thick spherical shell liquid guiding hole 2-1, a second thick spherical shell liquid guiding hole 2-2, a third thick spherical shell liquid guiding hole 2-3, and a fourth thick spherical shell liquid guiding hole 2-4 are symmetrically etched at positions of 0°, 90°, 180°, and 270°, respectively. [The text abruptly ends here, likely due to an incomplete sentence or missing information.] On the side of edge 2-6, and directly opposite the center of the first thick spherical shell liquid guiding hole 2-1, the second thick spherical shell liquid guiding hole 2-2, the third thick spherical shell liquid guiding hole 2-3, and the fourth thick spherical shell liquid guiding hole 2-4, a positioning line is etched. The first annular protrusion 2-7 is embedded in the annular groove 1-7. The first thick spherical shell liquid guiding hole 2-1, the second thick spherical shell liquid guiding hole 2-2, the third thick spherical shell liquid guiding hole 2-3, and the fourth thick spherical shell liquid guiding hole 2-4 correspond one-to-one with the first thin spherical shell liquid guiding hole 1-1, the second thin spherical shell liquid guiding hole 1-2, the third thin spherical shell liquid guiding hole 1-3, and the fourth thin spherical shell liquid guiding hole 1-4, and have the same diameter.

[0115] See Figure 3A and Figure 3BAs shown, the special bracket is made of nylon substrate and machined. The special bracket consists of a base 3, a crossbar 4, a threaded rod 5, and a slider 6. A cylindrical through-hole 3-7 is etched inwards on the upper surface of the base 3. The inner diameter of the cylindrical through-hole 3-7 is larger than the outer diameter of the thick spherical shell body 2-5, and the depth of the cylindrical through-hole 3-7 is larger than the radius of the thick spherical shell body 2-5. An annular liquid retention groove 3-5 is etched on the upper surface of the base 3. The remaining portion between the annular liquid retention groove 3-5 and the cylindrical through-hole 3-7 forms a second annular protrusion 3-6. A positioning line is symmetrically etched at 0°, 90°, 180°, and 270° positions on the outer surface of the second annular protrusion 3-6, respectively. Positioning lines are also etched at 0°, 90°, 180°, and 270° positions on the upper surface of the base 3 near the outer region. Four sets of circular hole arrays 3-1, 3-2, 3-3 and 3-4 with the same inner diameter are symmetrically etched. Each set of circular hole arrays contains three circular holes with the same inner diameter and internal threads. The distance between the centers of adjacent circular holes in each set of circular hole arrays is the same. A first rectangular through hole 3-8 is opened on the side of the lower part of the base 3. The first rectangular through hole 3-8 forms a communication structure with the cylindrical through hole 3-7. The width of the first rectangular through hole 3-8 is not less than 200mm and the height is not less than 50mm. The lower edge of the first rectangular through hole 3-8 is not less than 20mm from the bottom surface of the base 3.

[0116] See Figure 3C As shown, the first round through hole 4-1 and the second round through hole 4-2 are symmetrically etched on both sides of the crossbar 4. The first side round through hole 4-3 and the second side round through hole 4-4 are vertically etched on the side of the crossbar 4. The first round through hole 4-1 is connected to the first side round through hole 4-3, and the second round through hole 4-2 is connected to the second side round through hole 4-4. The first side round through hole 4-3 and the second side round through hole 4-4 are provided with threads. A screw is passed through the first side round through hole 4-3 and the second side round through hole 4-4 and tightened, so that the crossbar 4 is kept at a fixed height on the threaded rod 5. The second rectangular through hole 4-5 is etched in the middle position of the crossbar 4.

[0117] See Figure 3A , Figure 3B , Figure 3C and Figure 3DAs shown, the threaded rod 5 includes two identical first threaded rods 5-1 and second threaded rods 5-2. Each threaded rod has threads at its bottom and can be screwed into any one of the round holes in 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 top diameter of the first threaded rod 5-1 and the second threaded rod 5-2 is slightly smaller than the inner diameter of the first round through hole 4-1 and the second round through hole 4-2. The upper ends of the first threaded rod 5-1 and the second threaded rod 5-2 pass through the first through hole 4-1 and the second through hole 4-2, respectively. Plastic screws are then passed through the first side through hole 4-3 and the second side through hole 4-4 and tightened, thus fixing the relative position of the crossbar 4 with the first threaded rod 5-1 and the second threaded rod 5-2. The lower end of the first threaded rod 5-1 is threadedly connected to any one of the holes in the first circular hole array 3-1. The lower end of the second threaded rod 5-2 is threadedly connected to a hole in the third circular hole array 3-3, symmetrical to the hole connected to the first threaded rod 5-1. At this time, the holes connected to the first threaded rod 5-1 and the second threaded rod 5-2... The center line connecting the connected circular holes is parallel to the center line connecting all the circular holes in the second circular hole array 3-2 and the center line connecting all the circular holes in the fourth circular hole array 3-4; or the lower end of the first threaded rod 5-1 is threaded to any one of the circular holes in the second circular hole array 3-2, and the lower end of the second threaded rod 5-2 is threaded to the circular hole in the fourth circular hole array 3-4 that is symmetrical to the circular hole connected to the lower end of the first threaded rod 5-1. In this case, the center line connecting the circular hole connected to the first threaded rod 5-1 and the circular hole connected to the second threaded rod 5-2 is parallel to the center line connecting all the circular holes in the first circular hole array 3-1 and the center line connecting all the circular holes in the third circular hole array 3-3.

[0118] See Figure 3E and Figure 3F As shown, slider 6 consists of a left slider 6-1 and a right slider 6-2 with identical and symmetrical structures. A first symmetrical through hole 6-3 and a second symmetrical through hole 6-4 are drilled in the rectangular block of the upper half of the left slider 6-1, and a first through hole 6-7 is drilled in the square block of the lower half of the left slider 6-1. A third symmetrical through hole 6-5 and a fourth symmetrical through hole 6-6 are provided in the rectangular block of the upper half of the right slider 6-2, corresponding to the positions of the first symmetrical through hole 6-3 and the second symmetrical through hole 6-4. The square block of the lower half of the right slider 6-2 is provided with a second through hole 6-8 corresponding to the first through hole 6-7. All four symmetrical through holes and the inner walls of the first through hole 6-7 and the second through hole 6-8 are provided with threads. After the left slider 6-1 and the right slider 6-2 are assembled together, the upper surface of the left slider 6-1 and the right slider 6-2 assembled as one body is drilled with a top through hole 6-9. The lower half of the slider 6 is provided with a T-shaped through hole 6-10, and the crossbar 4 can be inserted into the upper half of the T-shaped through hole 6-10.

[0119] See Figure 4A and Figure 4B As shown, the magnetic field measurement probe 7 includes a probe body 7-1 and a protective shell 7-2. Three high-precision Hall elements are built into the probe body 7-1. These three Hall elements are orthogonally distributed in three dimensions and fixed within the cuboid-shaped probe body 7-1. The voltage signal generated by the Hall elements after being stimulated by an alternating magnetic field is calculated by the control computer 10 to obtain the magnetic field signal. The data lines of the three-dimensional orthogonal Hall elements pass through the top of the probe body 7-1, then through the protective shell 7-2, and connect to the device host 9. After the probe body 7-1 is assembled, it is filled with resin rubber to achieve a waterproof seal for the Hall elements and their circuit boards. Simultaneously, the protective shell 7-2 is vertically fixed to the upper surface of the probe body 7-1. The diameter of the probe body 7-1 is 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. Positioning lines are etched on the upper surface of the protective shell 7-2 for positioning during the assembly of the dedicated bracket.

[0120] See Figure 1 Figure 3 and Figure 4A and Figure 4B As shown, 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 shell 7-2 and align the positioning line on the protective shell 7-2 with the lower surface of the T-shaped through hole 6-10. The crossbar 4 is embedded in the upper half of the T-shaped through hole 6-10. The plastic screws pass 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 respectively and are fixed by nuts. The plastic screws are threaded to the first through hole 6-7 and the second through hole 6-8 and tightened to fix the slider 6 to the crossbar 4.

[0121] The method using specialized equipment for detecting the magnetic field and temperature of a transcranial magnetic stimulation (TMS) therapy device includes the following steps:

[0122] Step 1: Design and fabricate a bionic head phantom, whose structure and geometric dimensions are close to those of a real human head; the bionic head phantom is used to form a physiological structure similar to that of a real human head.

[0123] Step 2: Based on the conductivity and relative permittivity of human cerebrospinal fluid and cerebral gray matter, prepare equivalent solutions for cerebrospinal fluid and cerebral gray matter; these solutions are used to create a detection environment similar to the electromagnetic properties of real human brain tissue.

[0124] The method for preparing equivalent solutions of cerebrospinal fluid and cerebral gray matter uses pure water as the base material. Salts and sugars are added to adjust the conductivity and relative permittivity of the tissue equivalent solutions, making the conductivity and relative permittivity of the two equivalent solutions equivalent to those of real human cerebrospinal fluid and cerebral gray matter, respectively. The conductivity of real human cerebrospinal fluid is 1.00–2.51 S / m, and the relative permittivity is 109 ± 30. The conductivity of real human cerebral gray matter is 0.06–2.47 S / m, and the relative permittivity is 85600 ± 25000. All relative permittivity values ​​were measured and calibrated at a frequency of 2.8 kHz.

[0125] Step 3: Assemble the bionic head model and inject cerebrospinal fluid equivalent solution and cerebral gray matter equivalent solution. Place the thick spherical shell 2 into the base 3 and rotate the thick spherical shell 2 so that the positioning lines of the thick spherical shell edge 2-6 correspond one-to-one with the positioning lines of the second annular protrusion 3-6. Inject the cerebrospinal fluid equivalent 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 put the thin spherical shell 1 into the thick spherical shell 2. The cerebrospinal fluid equivalent solution flows upward along its outer wall due to the pressure of the thin spherical shell 1.

[0126] Rotating the thin spherical shell 1 causes the first annular protrusion 2-7 to be embedded in the annular groove 1-7, and aligns the first thin spherical shell liquid guiding hole 1-1, the second thin spherical shell liquid guiding hole 1-2, the third thin spherical shell liquid guiding hole 1-3, and the fourth thin spherical shell liquid guiding hole 1-4 with the first thick spherical shell liquid guiding hole 2-1, the second thick spherical shell liquid guiding hole 2-2, the third thick spherical shell liquid guiding hole 2-3, and the fourth thick spherical shell liquid guiding hole 2-4 respectively.

[0127] The equivalent cerebrospinal fluid solution exceeding the volume of the gap between the thin spherical shell 1 and the thick spherical shell 2 is discharged through the first thin spherical shell drainage hole 1-1, the second thin spherical shell drainage hole 1-2, the third thin spherical shell drainage hole 1-3 and the fourth thin spherical shell drainage hole 1-4, and the first thick spherical shell drainage hole 2-1, the second thick spherical shell drainage hole 2-2, the third thick spherical shell drainage hole 2-3 and the fourth thick spherical shell drainage hole 2-4, and then accumulates in the annular retention tank 3-5; finally, the equivalent solution of cerebral gray matter is injected into the thin spherical shell 1 until the liquid level reaches four-fifths of the internal height of the thin spherical shell 1.

[0128] Step 4: Assemble the special bracket, magnetic field measuring probe 7, and temperature measuring module 8. Screw the lower end of the first threaded rod 5-1 into any one of the circular holes in the first circular hole array 3-1 and connect them threadedly. Screw the lower end of the second threaded rod 5-2 into a circular hole in the third circular hole array 3-3, which is symmetrical to the circular hole into which the lower end of the first threaded rod 5-1 is screwed, and connect them threadedly. At this time, the line connecting the centers of the circular holes connected to the first threaded rod 5-1 and the circular holes connected to the second threaded rod 5-2 is parallel to the line connecting the centers of all the circular holes in the second circular hole array 3-2 and the fourth circular hole array 3-3. -4 The line connecting the centers of all the holes in the array; or the lower end of the first threaded rod 5-1 is screwed into any one of the holes in the second hole array 3-2 and threaded, and the lower end of the second threaded rod 5-2 is screwed into a hole in the fourth hole array 3-4 that is symmetrical to the hole into which the lower end of the first threaded rod 5-1 is screwed and threaded. At this time, the line connecting the centers of the holes connected by the first threaded rod 5-1 and the holes connected by the second threaded rod 5-2 is parallel to the line connecting the centers of all the holes in the first hole array 3-1 and the line connecting the centers of all the holes in the third hole array 3-3.

[0129] Then, the magnetic field measuring probe 7 is passed through the second rectangular through hole 4-5, and the protective shell 7-2 is clamped by the left slider 6-1 and the right slider 6-2, so that the positioning line on the protective shell 7-2 is aligned with the lower surface of the T-shaped through hole 6-10, while the crossbar 4 is inserted into the upper part of the T-shaped through hole 6-10; plastic screws are passed through the first symmetrical through hole 6-3 and the third symmetrical through hole 6-5, the second symmetrical through hole 6-4 and the fourth symmetrical through hole 6-6 respectively, and fixed with nuts; at the same time, plastic screws are passed through the first through hole 6-7 and the second through hole 6-8 and tightened to fix the relative position of the slider 6 and the crossbar 4;

[0130] The fixed crossbar 4, slider 6, and magnetic field measuring probe 7 are inserted as a whole into the brain gray matter equivalent solution in the thin spherical shell 1, so that the first threaded rod 5-1 and the second threaded rod 5-2 pass through the first round hole 4-1 and the second round hole 4-2 respectively; adjust the relative position of slider 6 on crossbar 4, and then adjust the relative height of crossbar 4 and threaded rod 5 so that probe body 7-1 reaches the measuring position; finally, use plastic screws to pass through the first side round hole 4-3 and the second side round hole 4-4 respectively to fix crossbar 4 to the first threaded rod 5-1 and the second threaded rod 5-2; attach temperature measuring module 8 to the surface of stimulation coil of transcranial magnetic stimulation therapy device;

[0131] The method for selecting the measurement position of the probe body 7-1 is as follows: the numerical models corresponding to the thin spherical shell 1 and the thick spherical shell 2 are imported into the simulation software. The conductivity and relative permittivity of the thin spherical shell 1 and the thick spherical shell 2 are assigned to the values ​​corresponding to the human skull. The space between the thin spherical shell 1 and the thick spherical shell 2 is assigned to the conductivity and relative permittivity of the cerebrospinal fluid. The space inside the thin spherical shell 1 is assigned to the conductivity and relative permittivity of the gray matter of the brain. Then, the circular stimulation coil and the figure-eight stimulation coil commonly used in transcranial magnetic stimulation therapy are abstracted and established as numerical models with their respective coil radius, number of turns and other geometric structural features. The current intensity and current frequency characteristic parameters in the numerical model of the stimulation coil are assigned to the corresponding values ​​of the stimulation sequence in step 5.

[0132] The magnetic field distribution inside the thin spherical shell 1 was calculated using the finite element method when using different stimulation coils. For different stimulation coils, appropriate measurement positions needed to be selected based on the magnetic field distribution characteristics. Specifically, when measuring the maximum magnetic induction intensity, output frequency, and stimulation pulse width of all stimulation coils, the probe body 7-1 should be placed at the lowest position inside the thin spherical shell 1. When measuring the magnetic field distribution inside the thin spherical shell 1, appropriate spatial coordinates, i.e., x-coordinate, y-coordinate, and z-coordinate, should be selected based on the structure 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 magnetic field distribution characteristics of different stimulation coils. In the spatial x-coordinate, y-coordinate, and z-coordinate, the x-coordinate is determined by the structure and position 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 slider 6 and the crossbar 4; and the z-coordinate is determined by the depth to which the probe body 7-1 is inserted into the thin spherical shell 1.

[0133] The positioning method for the probe body 7-1 is as follows: Before each positioning of the measurement position, first adjust the relative position of the slider 6 on the crossbar 4, and use a steel ruler to measure the distance between each side of the slider 6 and the end of the crossbar 4 on the same side until the slider 6 is in the center position of the crossbar 4. Then adjust the relative height of the crossbar 4 and the threaded rod 5 so that the end surface of the protective shell 7-2 coincides with the plane of the upper surface of the thin spherical shell edge 1-6.

[0134] During 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 measurement position to determine the x-coordinate; then the slider 6 is moved and the distance between its two sides and the end of the crossbar 4 on the same side is measured with a steel ruler until the target y-coordinate is reached; the insertion depth of the probe 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 with a steel ruler until the target z-coordinate is reached.

[0135] The specific steps for magnetic field and temperature detection include: for any parameter and any measurement location, at least 6 consecutive measurements should be taken, and the average value should be taken as the final measurement result.

[0136] Step 5: Set the stimulation sequence of the transcranial magnetic stimulation (TMS) device, begin magnetic field and temperature detection, insert the stimulation coil of the TMS device into the first rectangular through-hole 3-8, ensuring the center of the coil is flush against but not pressing against the thick spherical shell body 2-5. If flush against, insert an acrylic plate into the first rectangular through-hole 3-8 to raise the stimulation coil. Using the repetitive pulse stimulation mode, after the probe body 7-1 reaches the measurement position, measure the maximum magnetic induction intensity, spatial magnetic field distribution, output frequency, stimulation pulse width, and coil surface temperature, and perform data analysis and uncertainty assessment on the measurement results. The data analysis and uncertainty assessment include the following steps:

[0137] Step 5-1: Trace the steel ruler to the national length standard, trace the magnetic field measuring probe 7 to the national electromagnetic standard, and trace the temperature measuring module 8 to the national temperature standard to obtain the accuracy class, resolution, or uncertainty of the above equipment.

[0138] Step 5-2: For the obtained magnetic field strength measurement results or temperature measurement results, outliers are removed according to the Dickson criterion, and the standard deviation of the evaluated parameter is calculated based on the number of measurements.

[0139] Step 5-3: Evaluate the uncertainty of the magnetic field strength measurement results or temperature measurement results. Based on the accuracy class, resolution or uncertainty obtained in Step 5-1, analyze the Type A standard uncertainty and Type B standard uncertainty introduced by the steel ruler, magnetic field measuring probe 7, temperature measuring module 8, etc. Then analyze the correlation of the above types of uncertainty and synthesize the expanded uncertainty to evaluate the reliability of the measurement results.

[0140] Please see Figures 1-7 As shown in the figure, a method for detecting the magnetic field and temperature of a transcranial magnetic stimulation therapy device according to a preferred embodiment of the present invention mainly includes the following steps:

[0141] The first step is to design and fabricate a biomimetic head phantom that is approximately the same size and structure as a real human head and whose tissue electromagnetic properties are equivalent in the frequency band covered by transcranial magnetic stimulation.

[0142] like Figures 2A-2C The image shows the design of a bionic head phantom. The bionic head phantom is similar in size and structure to a real human head, and its tissue electromagnetic properties are equivalent in the frequency band covered by transcranial magnetic stimulation. The phantom is lightweight and easy to assemble and transport.

[0143] See Figure 2BAs shown, the thin spherical shell 1 serves as a separator between the gray matter layer and the cerebrospinal fluid layer. It should maintain high hardness and high stability. It consists of a thin spherical shell body 1-5 with a wall thickness of 3 mm and an inner diameter of 148 mm, and a thin spherical shell edge 1-6 with a width of 26 mm (including the wall thickness of the thin spherical shell body 1-5). Among them, the lower edge of the thin spherical shell edge 1-6 is symmetrically etched with a width of 10 mm, a depth of 5 mm, and a length of 5 mm for the first thin spherical shell edge fluid guiding hole 1-1, the second thin spherical shell edge fluid guiding hole 1-2, the third thin spherical shell edge fluid guiding hole 1-3, and the fourth thin spherical shell fluid guiding hole 1-4 at 0°, 90°, 180°, and 270°. The edge of the thin spherical shell edge 1-6 is etched with an annular groove 1-7 with a width of 10 mm and a depth of 10 mm near the thin spherical shell body 1-5.

[0144] See Figure 2C As shown, the thick spherical shell 2 is used to simulate the scalp-skull layer, and consists of a thick spherical shell body 2-5 with a wall thickness of 12 mm and an inner diameter of 160 mm, and a thick spherical shell edge 2-6 with a width of 20 mm (including the wall thickness of the thick spherical shell body 2-5). A first annular protrusion 2-7 with a width of 7 mm and a height of 5 mm is provided above the inner edge of the thick spherical shell body 2-5. Symmetrically etched at 0°, 90°, 180°, and 270° positions are four thick spherical shell liquid guiding holes 2-1, 2-2, 2-3, and 2-4, each with a diameter of 10 mm. Four positioning lines are etched at the side of the thick spherical shell edge 2-6 and at the center of the first thick spherical shell liquid guiding holes 2-1, 2-2, 2-3, and 2-4. The outer diameter of the thin spherical shell body 1-5 is slightly smaller than the inner diameter of the thick spherical shell 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. The width of the annular protrusion 2-7 is smaller than the width of the thick spherical shell edge 2-6, and the first annular protrusion 2-7 can be embedded in the annular groove 1-7. The dimensions of the first thick spherical shell liquid guiding hole 2-1, the second thick spherical shell liquid guiding hole 2-2, the third thick spherical shell liquid guiding hole 2-3, and the fourth thick spherical shell liquid guiding hole 2-4 are the same as the dimensions of the first thin spherical shell edge liquid guiding hole 1-1, the second thin spherical shell edge liquid guiding hole 1-2, the third thin spherical shell edge liquid guiding hole 1-3, and the fourth thin spherical shell liquid guiding hole 1-4. After the cerebrospinal fluid equivalent solution overflows, it can be guided through the first thick spherical shell liquid guiding hole 2-1, the second thick spherical shell liquid guiding hole 2-2, the third thick spherical shell liquid guiding hole 2-3, and the fourth thick spherical shell liquid guiding hole 2-4 to the first thin spherical shell liquid guiding hole 1-1, the second thin spherical shell liquid guiding hole 1-2, the third thin spherical shell liquid guiding hole 1-3, and the fourth thin spherical shell liquid guiding hole 1-4, respectively.

[0145] like Figures 3A-3F It features a specially designed support structure made of nylon. The support structure includes a base 3, a crossbar 4, a threaded rod 5, and a slider 6. When used with a high-precision steel ruler, it can be used for the precise positioning of bionic head phantoms, magnetic field measurement probes, and transcranial magnetic stimulation therapy coils.

[0146] See Figure 3B As shown, the base 3 is an integral structure made from a cylindrical acrylic nylon substrate with a diameter of 300mm and a height of 170mm, which has no impact on the measurement of the magnetic field signal. A cylindrical through hole 3-7 with a 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 greater than the radius of the thick spherical shell body 2-5, which can accommodate the thick spherical shell body 2-5. An annular drainage groove 3-5 with a depth of 10mm and a width of 20mm is etched on the upper surface of the base 3 to collect overflowing cerebrospinal fluid. The annular drainage groove 3-5 and the edge of the upper surface of the base 3 form a second annular protrusion 3-6 with a width of 20mm. A positioning line is symmetrically etched at 0°, 90°, 180° and 270° positions on the side of the second annular protrusion 3-6. On the upper surface of the base 3, near the outer side, a first circular hole array 3-1, a second circular hole array 3-2, a third circular hole array 3-3, and a fourth circular hole array 3-4 are symmetrically etched at 0°, 90°, 180°, and 270° positions. All holes in each array have internal threads, an inner diameter of 15mm, and a depth of at least 20mm. A first rectangular through-hole 3-8, 200mm wide and 50mm high, is provided on the lower side of the base 3. This first rectangular through-hole 3-8 communicates with the cylindrical through-hole 3-7. The lower edge of the first rectangular through-hole 3-8 is 20mm from the bottom surface of the base 3.

[0147] See Figure 3C As shown, the crossbar 4 has symmetrically etched first circular through-holes 4-1 and 4-2 on both sides. The crossbar 4 also has vertically etched first side circular through-holes 4-3 and 4-4 on its sides. The first circular through-hole 4-1 and the first side circular through-hole 4-3 are connected, as are the second circular through-holes 4-2 and 4-4. The first side circular through-holes 4-3 and 4-4 have internal threads. A second rectangular through-hole 4-5, 160mm long and 16mm wide, is etched in the middle of the crossbar 4. This second rectangular through-hole 4-5 is used for the magnetic field measuring probe 7 to pass through. The crossbar 4 can be fixed in height by tightening screws through the first side circular through-holes 4-3 and 4-4.

[0148] See Figure 3D As shown, the threaded rod 5 includes two identical first threaded rods 5-1 and second threaded rods 5-2, each with a height of 200mm. Each threaded rod has threads at its bottom and can be screwed into any one of the circular holes in 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 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 through hole 4-1 and the second through hole 4-2 on the base.

[0149] See Figure 3E and Figure 3FAs shown, slider 6 is made of cuboid nylon material and includes a left slider 6-1 and a right slider 6-2 with identical and symmetrical structures. The left slider 6-1 and right slider 6-2 are used to fix the horizontal position of the measuring probe on the crossbar 4. The upper half of the rectangular block of the left slider 6-1 is drilled with a first symmetrical through hole 6-3 and a second symmetrical through hole 6-4, and the lower half of the square block of the left slider 6-1 is drilled with a first through hole 6-7. The upper half of the rectangular block of the right slider 6-2 is drilled with a third symmetrical through hole 6-5 and a fourth symmetrical through hole 6-6 at positions corresponding to the first symmetrical through hole 6-3 and the second symmetrical through hole 6-4, and the lower half of the square block of the right slider 6-2 is drilled with a second through hole 6-8 and has internal threads. The inner walls of the first symmetrical through hole 6-3, the second symmetrical through hole 6-4, the third symmetrical through hole 6-6, and the fourth symmetrical through hole 6-7 are all threaded. The left slider 6-1 and the right slider 6-2 are assembled together to form slider 6. A top through hole 6-9 is drilled on the top of slider 6. The lower half of slider 6 has a T-shaped through hole 6-10, and the nested crossbar 4 can move on slider 6.

[0150] like Figure 4A and Figure 4B As shown, the magnetic field measurement probe 7 includes a probe body 7-1 and a protective shell 7-2. The probe body 7-1 has an outer diameter of 14 mm, a width of 12 mm, a height of 50 mm, and a shell thickness of 2 mm. The probe body 7-1 houses three high-precision Hall elements with similar response speeds: two surface-mount Hall elements H1 and H2, and one through-hole Hall element H3. The three Hall elements are spatially orthogonally distributed in three dimensions and precisely fixed to the probe body 7-1. The center of the surface-mount Hall element H1 is 8 mm from the inner bottom surface of the probe body 7-1, the center of the surface-mount Hall element H2 is 3 mm from the inner bottom surface of the probe body 7-1, and the center of the through-hole Hall element H3 is 15 mm from the inner bottom surface of the probe body 7-1. The data cable of the three-dimensional orthogonal Hall element exits from the top of the probe body 7-1, then passes through the protective shell 7-2 and connects to the main unit 9. After the probe body 7-1 is assembled, it is filled with resin rubber to achieve a waterproof seal for the Hall element and its circuit board. At the same time, the protective shell 7-2 is vertically fixed to the upper surface of the probe body 7-1. The width of the probe 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 slider 6.

[0151] In addition, equivalent solutions of cerebrospinal fluid and cerebral gray matter were prepared by adding sodium chloride, potassium chloride, and glucose to primary pure water, and their conductivity and relative permittivity were measured at 2.8 kHz. The conductivity of the cerebrospinal fluid equivalent solution was 2.01 S / m, and the relative permittivity was 130; the conductivity of the cerebral gray matter equivalent solution was 0.11 S / m, and the relative permittivity was 80500.

[0152] The second step involves assembling the bionic head phantom and dedicated support. The main unit 9 is then connected to the magnetic field measuring probe 7, temperature measuring module 8, and control computer 10 via data cable 11, and the power is turned on for each device. The stimulation coil of the transcranial magnetic stimulation (TMS) device is inserted into the first rectangular through-hole 3-8 on the base 3, ensuring the coil's center is flush against the thick spherical shell body 2-5 without compressing it. If a flush fit is not possible, an appropriately sized acrylic plate can be placed in the first rectangular through-hole 3-8 to elevate the stimulation coil.

[0153] The third step involves setting up the stimulation sequence of the transcranial magnetic stimulation (TMS) device, running the dedicated equipment for detecting the magnetic field and temperature of the TMS device to collect and analyze the magnetic field and temperature signals, and evaluating the uncertainty of the measurement results.

[0154] In order to better reproduce the content of the present invention, the aforementioned magnetic field and temperature measurement principles, processes and results are briefly described below.

[0155] The Hall effect refers to the phenomenon where a current flows through a Hall element. I When an external magnetic field perpendicular to the current direction is applied, electrons and holes in the semiconductor, driven by voltage and moving in a directional manner, will gather in different directions and generate an electric field. When the electric force on the directionally moving particles is balanced with the Lorentz force, the electrons and holes no longer deflect, and the resulting built-in voltage is called the Hall voltage. U H , can be represented as:

[0156] (1)

[0157] in, d The thickness of the Hall element, I The current intensity applied inside the conductor. B The magnetic field strength, R H It is a Hall resistor.

[0158] According to equation (1), the magnetic induction intensity B With Hall voltage U H The two are linearly correlated, and the magnetic flux density can be calculated using the Hall voltage.

[0159] The thermoelectric effect refers to the phenomenon of electric current or charge accumulation that occurs when electrons (holes) in a heated object migrate from a high-temperature region to a low-temperature region along a temperature gradient. The magnitude of this effect is represented by thermal energy (Q), and is defined as:

[0160] (2)

[0161] in, E The electric field generated by the accumulation of charge. dT This represents the temperature gradient.

[0162] According to equation (2), the temperature gradient generated on both sides of the sensor is linearly related to the electric potential, and the temperature gradient can be calculated from the electric potential.

[0163] In this invention, measuring the maximum magnetic induction intensity refers to setting the output frequency of the transcranial magnetic stimulation (TMS) therapy device's stimulation sequence to 10Hz, the output intensity to 100%, the stimulation duration to 1s, and the stimulation cluster interval to 2s, according to... Figure 6 Place the magnetic field measuring probe 7 vertically against the surface of the stimulation coil 13, and measure the magnetic induction intensity at measurement positions 13-1, 13-2, 13-3 and 13-4 respectively. Repeat the measurement 6 times at each measurement point.

[0164] In this invention, the measurement of magnetic induction intensity at a spatial point refers to setting the output frequency of the transcranial magnetic stimulation therapy device's stimulation sequence to 10Hz, the output intensity to 100%, the stimulation duration to 1s, and the stimulation cluster interval to 2s. According to... Figure 7 Select measurement points and place the probe body 7-1 at each point sequentially, ensuring that each measurement point is 10mm from the lower surface of the probe body. Repeat the measurement 6 times at each point. The measurement points consist of 19 spatial measurement points in 3 layers inside the thin spherical shell body 1-5, where O' to Ⅱ' are the layer numbers of the measurement points. Layer 0' contains only one measurement point, located at the center of the bottom surface inside the thin spherical shell body 1-5, specifically 10mm from the lowest point inside the thin spherical shell body 1-5; the distance between layer O' and layer Ⅰ', and the height difference between layer Ⅰ' and layer Ⅱ', are both 15mm. Layers Ⅰ' and Ⅱ' each contain 9 measurement points, and the plane formed by the measurement points in each layer is parallel to the upper surface of the thin spherical shell body 1-5. (See reference...) Figure 7 The coordinate axes in the diagram show that the distance difference between the measurement points in each row (y-axis direction) of layer I' and layer II' is 20 mm, and the distance difference between the measurement points in each column (x-axis direction) is 15 mm.

[0165] The measurement of output frequency refers to setting the output frequency of the transcranial magnetic stimulation (TMS) therapy device stimulation sequence to 5Hz and 10Hz, with an output intensity of 80%, a stimulation duration of 1s, and a stimulation cluster interval of 2s; and setting the output frequency of the stimulation sequence to 25Hz, with an output intensity of 50%, a stimulation duration of 1s, and a stimulation cluster interval of 2s. Under these three output frequency conditions, the following measurements are taken: Figure 7 The magnetic field signal at each output frequency was measured at point O', and the output frequency measurement results were calculated. The measurement was repeated 6 times at each output frequency.

[0166] Measuring the pulse width of a transcranial magnetic stimulation (TMS) device involves setting the output frequency of the stimulation sequence to 5Hz and 10Hz, with an output intensity of 80%, a stimulation duration of 1s, and a cluster interval of 2s; and setting the output frequency of the stimulation sequence to 25Hz, with an output intensity of 50%, a stimulation duration of 1s, and a cluster interval of 2s. Under these three output frequency conditions, the pulse width is measured... Figure 7 The magnetic field signal at each output frequency was measured at point O', and the stimulation pulse width was calculated. The measurement was repeated 6 times at each output frequency.

[0167] Measuring the coil surface temperature refers to setting the output frequency of the transcranial magnetic stimulation (TMS) therapy device's stimulation sequence to 10Hz, output intensity to 100%, stimulation duration to 1s, and stimulation cluster interval to 2s. According to... Figure 6 The temperature measurement module was attached to measurement positions 13-1, 13-2, 13-3, and 13-4 in eight separate steps to measure the coil surface temperature at each position. Six stimulation sequences were measured continuously at each measurement position, and the data were recorded.

[0168] After the above steps, the measurement results of the maximum magnetic induction intensity, spatial magnetic field distribution, output magnetic field frequency, output magnetic field stimulation pulse width and coil surface temperature of the transcranial magnetic stimulation therapy device are shown in Tables 1 to 6.

[0169] Table 1. Measurement results of maximum magnetic flux density after removing outliers (unit: T)

[0170]

[0171] Table 2 Simulation results of maximum magnetic flux density (unit: T)

[0172]

[0173] As shown in Tables 1 and 2, the maximum magnetic induction intensity that can be achieved on the surface of the stimulation coil is 2.227T, which is slightly higher than the 2.122T obtained from the simulation. The deviation between the simulation and the actual measurement is about 4.71%. The simulation and actual data are in good agreement, and the detection device can complete the function of measuring magnetic induction intensity in space.

[0174] Table 3 Comparison of simulated and measured values ​​of magnetic induction intensity inside the thin spherical shell.

[0175]

[0176] According to Table 3, the simulation results are similar to the actual measurement results, indicating that the detection device can complete the function of measuring the magnetic induction intensity in the solution.

[0177] Table 4 Output frequency measurement results (unit: Hz)

[0178]

[0179] According to Table 4, the relative deviation between the measured output frequency of the TMS therapy device and the set value is within 0.60%, indicating that the output frequency of the device is relatively stable.

[0180] Table 5. Measurement results of stimulation pulse width (unit: μs)

[0181]

[0182] According to Table 5, the actual stimulation pulse width of the TMS therapy device is unstable, and there is no fixed trend in the stimulation pulse width as the output frequency changes. Referring to the technical manual of this transcranial magnetic stimulation therapy device, the set value for the stimulation pulse width is 404.56 μs. Therefore, the maximum relative deviation between the measured stimulation pulse width and the set value is 3.32%. The detection device can perform the function of measuring the stimulation pulse width.

[0183] Table 6. Coil surface temperature measurement results (unit: °C)

[0184]

[0185] According to Table 6, the temperature measurement module can work normally and stably, and the detection device can realize the function of measuring the surface temperature of the coil in real time.

[0186] Furthermore, taking a set of data (2.166T, 2.206T, 2.186T, 2.218T, 2.184T, and 2.194T) from the measurement of the maximum magnetic induction intensity on the coil surface as examples, the method for evaluating the uncertainty of the measurement results is introduced. Each measurement result is the average of six measurements.

[0187] Step 1: Remove outliers

[0188] When a magnetic field measurement probe is operating, mechanical and electronic noise can introduce outliers into the measurement results. According to the Dixon criterion, the magnetic flux density is arranged in ascending order as follows: That is, 2.166T, 2.206T, 2.186T, 2.218T, 2.184T, and 2.194T. The statistic is then calculated according to formula (3). and .

[0189] (3)

[0190] Solving , .

[0191] Based on experience, outliers in magnetic flux density can appear on both sides; by referring to a table, the critical value of the Dixon criterion can be obtained. . No outliers were found in this measurement.

[0192] Step 2: Standard deviation of magnetic induction intensity measurement

[0193] For the magnetic field strength value corresponding to each spatial point, the optimal estimate is the average of multiple measurements, expressed as:

[0194] (4)

[0195] (5)

[0196] Where n represents the number of independent measurements.

[0197] In this measurement, n = 6. Measurement standard deviation .

[0198] Step 3: Uncertainty Assessment

[0199] At a reference temperature of 20 ℃, factors introducing measurement uncertainty during the measurement process include the readings of the magnetic field measuring probe, the steel ruler used for length measurement, the temperature sensor readings, and human operation. The measurement model for magnetic induction intensity can be expressed as:

[0200] (6)

[0201] In the formula: —Measured magnetic flux density value converted by the probe;

[0202] —Probe resolution;

[0203] —Magnetic induction intensity deviation introduced by positioning accuracy;

[0204] —Magnetic induction intensity deviation introduced by temperature drift.

[0205] According to the measurement model, the influence quantities of magnetic induction intensity are:

[0206] (a) Magnetic flux density measurement,

[0207] The uncertainty introduced by repeated measurements (Type A uncertainty) is the standard uncertainty:

[0208] (b) Probe resolution,

[0209] The magnetic field measurement probe consists of three-axis Hall elements. The response characteristics of each Hall element can be obtained by using the relationship between voltage and a standard magnetic field. The probe was sent to the Electromagnetic Institute of the National Institute of Metrology, China for calibration. After the probe acquires the signal, the voltage across the Hall elements is displayed on a virtual oscilloscope. Therefore, the probe's resolution is limited by the voltage resolution of the virtual oscilloscope. Each channel of the oscilloscope uses an 8-bit ADC to generate 0~255 bytes, with each byte corresponding to 25mT. Assuming a rectangular distribution, the standard uncertainty (Type B uncertainty) introduced by the probe's resolution is:

[0210] (7)

[0211] (c) Positioning accuracy introduces deviation in magnetic induction intensity. The positioning error comes from the error of the steel ruler reading, the subjective reading error of the human eye, and the coil vibration error caused by the alternating current.

[0212] The expanded uncertainty of this measurement was determined using a 300mm first-precision steel ruler for length measurement. U =0.01mm+3×10 -6 L ( k =2), based on the calculation of expanded uncertainty, the standard uncertainty of the steel ruler measurement is:

[0213] (8)

[0214] The subjective reading error is 0.5 mm, which is greater than the indication error of the steel ruler. The probe positioning error caused by human operation is 1 mm, which is much greater than both the subjective reading error and the steel ruler's indication error. Based on experience, the maximum change in magnetic induction intensity caused by a 1 mm displacement is 257 mT. Based on experience, the uncertainty of human operation can be considered to follow a rectangular distribution. The standard uncertainty (Type A uncertainty) introduced by the positioning accuracy is:

[0215] (9)

[0216] (d) Magnetic flux density deviation caused by temperature drift

[0217] Based on the performance of the Hall element, the change in magnetic flux density caused by temperature variation at room temperature (20±2)℃ was determined. The maximum temperature drift coefficient of the Hall element built into the probe is -0.06‰ ℃. -1 Within the range of (0~4) T, the maximum magnetic flux density drift is 0.96 mT. Assuming a rectangular distribution, the standard uncertainty (Type B uncertainty) introduced by the temperature drift is:

[0218] (10)

[0219] Step 4: Correlation Determination

[0220] The uncertainties of multiple measurements taken by the probe and the uncertainties of the probe's converted magnetic flux density are somewhat correlated with the uncertainties introduced by the probe's resolution; therefore, a larger value should be taken. .

[0221] Step 5: Summary of Standard Uncertainty

[0222] Table 7 Summary of Uncertainty Components in Magnetic Field Measurement

[0223]

[0224] Step 6: Combine standard uncertainty

[0225] Substituting each component into equation (11), the combined standard uncertainty is obtained as follows:

[0226] (11)

[0227] Step 7: Expand Uncertainty

[0228] Choose degrees of freedom k =2, then the expanded uncertainty of this maximum magnetic flux density measurement result is U for:

[0229] U =2× =0.300T (12)

[0230] Compared to the average maximum magnetic flux density measurement result of 2.192T, the expanded uncertainty of this measurement result, 0.300T, is only 13% of that of the maximum magnetic flux density measurement result. In the field of electromagnetic measurement, this measurement result has a small uncertainty and is considered reliable.

[0231] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A dedicated device for detecting the magnetic field and temperature of a transcranial magnetic stimulation (TMS) therapy instrument, characterized in that: It includes a bionic head phantom, a special support, a magnetic field measuring probe (7), a temperature measuring module (8), a device host (9), a control computer (10), a data cable (11), and measuring software (12). The bionic head model consists of a thin spherical shell (1) on the upper layer and a thick spherical shell (2) on the lower layer. The thin spherical shell (1) and the thick spherical shell (2) are integral structures made of cylindrical acrylic substrate and cut. The bionic head model is set on the base (3). The magnetic field measuring probe (7) is set on the top of the slider (6) of the special bracket. The main unit (9) of the device is connected to the magnetic field measuring probe (7), the temperature measuring module (8) and the control computer (10) through the data cable (11). The measurement software (12) is installed in the control computer (10). The thin spherical shell (1) is composed of a thin spherical shell body (1-5) and a thin spherical shell edge (1-6). The thin spherical shell body (1-5) is a hemisphere with a wall thickness of no more than 3 mm and an inner diameter of 140-150 mm. The first thin spherical shell liquid guiding hole (1-1), the second thin spherical shell liquid guiding hole (1-2), the third thin spherical shell liquid guiding hole (1-3), and the fourth thin spherical shell edge (1-6) are symmetrically etched at positions of 0°, 90°, 180°, and 270° respectively. The shell has a liquid guiding hole (1-4), and an annular groove (1-7) is etched at the lower edge of the thin spherical shell edge (1-6) near the thin spherical shell body (1-5). The thick spherical shell (2) is composed of a thick spherical shell body (2-5) and a thick spherical shell edge (2-6). The thick spherical shell body (2-5) is a hemispherical shell with a wall thickness not exceeding 12 mm and an inner diameter of 150~165 mm. A first annular protrusion is provided above the thick spherical shell edge (2-6) and along the inner edge of the thick spherical shell body (2-5). Starting from (2-7), the first thick spherical shell liquid guiding hole (2-1), the second thick spherical shell liquid guiding hole (2-2), the third thick spherical shell liquid guiding hole (2-3), and the fourth thick spherical shell liquid guiding hole (2-4) are symmetrically etched at positions of 0°, 90°, 180°, and 270° respectively. On the side of the thick spherical shell edge (2-6) and directly opposite the first thick spherical shell liquid guiding hole (2-1), the second thick spherical shell liquid guiding hole (2-2), the third thick spherical shell liquid guiding hole (2-3), and the fourth thick spherical shell liquid guiding hole (2-4). A positioning line is etched at the center of each hole (2-4). The first annular protrusion (2-7) is embedded in the annular groove (1-7). The first thick spherical liquid guiding hole (2-1), the second thick spherical liquid guiding hole (2-2), the third thick spherical liquid guiding hole (2-3), and the fourth thick spherical liquid guiding hole (2-4) correspond one-to-one with the first thin spherical liquid guiding hole (1-1), the second thin spherical liquid guiding hole (1-2), the third thin spherical liquid guiding hole (1-3), and the fourth thin spherical liquid guiding hole (1-4) and have the same diameter.

2. The specialized device for detecting the magnetic field and temperature of a transcranial magnetic stimulation therapy instrument according to claim 1, characterized in that: The special bracket is made of nylon substrate and is cut to form a base (3), a crossbar (4), a threaded rod (5) and a slider (6). The upper surface of the base (3) is etched inward to form a cylindrical through hole (3-7). The inner diameter is larger than the outer diameter of the thick spherical shell body (2-5), and the depth of the cylindrical through hole (3-7) is larger than the radius of the thick spherical shell body (2-5). An annular liquid retention groove (3-5) is etched on the upper surface of the base (3). The remaining part between the annular liquid retention groove (3-5) and the cylindrical through hole (3-7) forms a second annular protrusion (3-6). A positioning line is symmetrically etched at 0°, 90°, 180° and 270° positions on the outer surface of the second annular protrusion (3-6). On the base (3) At positions of 0°, 90°, 180°, and 270° near the outer surface, four sets of circular hole arrays with the same inner diameter are symmetrically etched: a first circular hole array (3-1), a second circular hole array (3-2), a third circular hole array (3-3), and a fourth circular hole array (3-4). Each set of circular hole arrays contains three circular holes with the same inner diameter and internal threads. The distance between the centers of adjacent circular holes in each set of circular hole arrays is the same. A first rectangular through hole (3-8) is opened on the side of the lower part of the base (3). Hole (3-8) and cylindrical through hole (3-7) form a connected structure. The width of the first rectangular through hole (3-8) is not less than 200mm and the height is not less than 50mm. The lower edge of the first rectangular through hole (3-8) is not less than 20mm from the bottom surface of the base (3). The first round through hole (4-1) and the second round through hole (4-2) are symmetrically etched on both sides of the crossbar (4). The first side round through hole (4-3) and the second side round through hole (4-4) are vertically etched on the side of the crossbar (4). A circular through hole (4-1) is connected to a first side circular through hole (4-3), and a second circular through hole (4-2) is connected to a second side circular through hole (4-4). The first side circular through hole (4-3) and the second side circular through hole (4-4) are provided with threads. A screw is passed through the first side circular through hole (4-3) and the second side circular through hole (4-4) and tightened so that the crossbar (4) is kept at a fixed height on the threaded rod (5). A second rectangular through hole (4-5) is etched in the middle of the crossbar (4). The threaded rod (5) includes two identical first threaded rods (5-1) and second threaded rods (5-2). Each threaded rod has a thread at its bottom and can be screwed into any one of the round holes in 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 top diameter of the first threaded rod (5-1) and the second threaded rod (5-2) is smaller than the inner diameter of the first round through hole (4-1) and the second round through hole (4-2). The slider (6) consists of a left slider (6-1) and a right slider (6-2) with the same structure and symmetrical to each other. A first symmetrical through hole (6-3) and a second symmetrical through hole (6-4) are drilled on the rectangular block of the upper half of the left slider (6-1), and a first through hole (6-7) is drilled on the square block of the lower half of the left slider (6-1). A third symmetrical through hole (6-5) and a fourth symmetrical through hole (6-6) are provided on the rectangular block of the upper half of the right slider (6-2) at positions corresponding to the first symmetrical through hole (6-3) and the second symmetrical through hole (6-4). A second through hole (6-8) corresponding to the first through hole (6-7) is provided on the square block of the lower half of the right slider (6-2). All four symmetrical through holes and the inner walls of the first through hole (6-7) and the second through hole (6-8) are threaded. A top through hole (6-9) is provided on the upper surface of the left slider (6-1) and right slider (6-2) assembled as one piece. The lower half of the slider (6) is provided with a T-shaped through hole (6-10), and the crossbar (4) can be inserted into the upper half of the T-shaped through hole (6-10); The upper ends of the first threaded rod (5-1) and the second threaded rod (5-2) pass through the first through hole (4-1) and the second through hole (4-2) respectively. Then, plastic screws are passed through the first side through hole (4-3) and the second side through hole (4-4) respectively and tightened to fix the relative position of the crossbar (4) with the first threaded rod (5-1) and the second threaded rod (5-2). The lower end of the first threaded rod (5-1) is threaded to any one of the holes in the first hole array (3-1), and the lower end of the second threaded rod (5-2) is threaded to a hole in the third hole array (3-3) that is symmetrical to the hole connected to the first threaded rod (5-1). At this time, the hole connected to the first threaded rod (5-1) and the second threaded rod... (5-2) The line connecting the centers of the connected circular holes is parallel to the line connecting the centers of all the circular holes in the second circular hole array (3-2) and the line connecting the centers of all the circular holes in the fourth circular hole array (3-4); or the lower end of the first threaded rod (5-1) is threaded to any one of the circular holes in the second circular hole array (3-2), and the lower end of the second threaded rod (5-2) is threaded to the circular hole in the fourth circular hole array (3-4) that is symmetrical to the circular hole connected to the lower end of the first threaded rod (5-1). At this time, the line connecting the centers of the circular holes connected to the first threaded rod (5-1) and the circular holes connected to the second threaded rod (5-2) is parallel to the line connecting the centers of all the circular holes in the first circular hole array (3-1) and the line connecting the centers of all the circular holes in the third circular hole array (3-3).

3. A dedicated device for detecting the magnetic field and temperature of a transcranial magnetic stimulation therapy instrument according to claim 2, characterized in that: The magnetic field measuring probe (7) includes a probe body (7-1) and a protective shell (7-2). Three high-precision Hall elements are built into the probe body (7-1). These three Hall elements are orthogonally distributed in three dimensions and fixed within the cuboid-shaped probe body (7-1). The Hall elements generate voltage signals after being stimulated by an alternating magnetic field, and the magnetic field signal is calculated by a control computer (10). The data lines of the three-dimensional orthogonal Hall elements pass through the top of the probe body (7-1), then through the protective shell (7-2), and finally connect with… The device host (9) is connected; after the probe body (7-1) is assembled, resin rubber is used to inject the probe body (7-1) to achieve waterproof sealing of the Hall element and its circuit board, and the protective shell (7-2) is vertically fixed to the upper surface of the probe body (7-1); the diameter of the probe body (7-1) is smaller than 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 the positioning line is etched on the upper position of the protective shell (7-2) for positioning during the assembly of the special bracket; 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 shell (7-2) and make the positioning line on the protective shell (7-2) aligned with the lower surface of the T-shaped through hole (6-10). The crossbar (4) is embedded in the upper part of the T-shaped through hole (6-10). The plastic screws pass 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) respectively and are fixed by nuts; the plastic screws are threaded to the first through hole (6-7) and the second through hole (6-8) and tightened, so that the slider (6) is fixed to the crossbar (4).

4. A dedicated device for detecting the magnetic field and temperature of a transcranial magnetic stimulation therapy instrument according to claim 3, characterized in that: The temperature measurement module (8) mentioned therein includes a platinum resistance thermometer. The sensor generates a signal that is transmitted to the host device (9) via a data line (11). The host device (9) has a built-in virtual oscilloscope module to process and store the voltage signal generated by the Hall element in the probe body (7-1) and the voltage signal generated by the temperature measurement module (8). The control computer (10) controls the data acquisition process and displays, processes and saves the data.

5. A method using the specialized equipment for detecting the magnetic field and temperature of a transcranial magnetic stimulation therapy device as described in claim 3 or 4, characterized in that: The method includes the following steps: Step 1: Design and fabricate a bionic head phantom, whose structure and geometric dimensions are close to those of a real human head; the bionic head phantom is used to form a physiological structure similar to that of a real human head. Step 2: Based on the conductivity and relative permittivity of human cerebrospinal fluid and cerebral gray matter, prepare equivalent solutions for cerebrospinal fluid and cerebral gray matter; these solutions are used to create a detection environment similar to the electromagnetic properties of real human brain tissue. Step 3: Assemble the bionic head model and inject the equivalent solution of cerebrospinal fluid and the equivalent solution of cerebral gray matter. Place the thick spherical shell (2) into the base (3) and rotate the thick spherical shell (2) so that the positioning lines of the edge (2-6) of the thick spherical shell correspond one-to-one with the positioning lines of the second annular protrusion (3-6). Inject the equivalent solution of cerebrospinal fluid 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 put the thin spherical shell (1) into the thick spherical shell (2). The equivalent solution of cerebrospinal fluid flows upward along its outer wall due to the pressure of the thin spherical shell (1). Rotating the thin spherical shell (1) causes the first annular protrusion (2-7) to embed into the annular groove (1-7), and aligns 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) with 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) respectively; the cerebrospinal fluid exceeds the volume of the gap between the thin spherical shell (1) and the thick spherical shell (2). The equivalent solution, after being discharged through the first thin spherical shell liquid guiding hole (1-1), the second thin spherical shell liquid guiding hole (1-2), the third thin spherical shell liquid guiding hole (1-3), and the fourth thin spherical shell liquid guiding hole (1-4), and the first thick spherical shell liquid guiding hole (2-1), the second thick spherical shell liquid guiding hole (2-2), the third thick spherical shell liquid guiding hole (2-3), and the fourth thick spherical shell liquid guiding hole (2-4), is accumulated in the annular liquid retention tank (3-5); finally, the equivalent solution of cerebral gray matter is injected into the thin spherical shell (1) until the liquid level reaches four-fifths of the internal height of the thin spherical shell (1); Step 4: Assemble the special bracket, magnetic field measuring probe (7), and temperature measuring module (8). Screw the lower end of the first threaded rod (5-1) into any one of the holes in the first circular hole array (3-1) and connect them with threads. Screw the lower end of the second threaded rod (5-2) into a hole in the third circular hole array (3-3) that is symmetrical to the hole into which the lower end of the first threaded rod (5-1) is screwed, and connect them with threads. At this time, the line connecting the centers of the holes connected by the first threaded rod (5-1) and the holes connected by the second threaded rod (5-2) is parallel to the line connecting the centers of all the holes in the second circular hole array (3-2) and the line connecting the centers of all the holes in the fourth circular hole array (3-4). Alternatively, screw the lower end of the first threaded rod (5-1) into any one of the holes in the second circular hole array (3-2) and connect them with threads. Screw the lower end of the second threaded rod (5-2) into the hole connected to the hole in the first threaded rod (5-1). The lower end is screwed into the circular hole in the fourth circular hole array (3-4) with the circular hole being symmetrical and connected by threads. At this time, the line connecting the center of the circular hole connected by the first threaded rod (5-1) and the circular hole connected by the second threaded rod (5-2) is parallel to the line connecting the center of all the circular holes in the first circular hole array (3-1) and the line connecting the center of all the circular holes in the third circular hole array (3-3). Then, the magnetic field measuring probe (7) is passed through the second rectangular through hole (4-5), and the left slider (6-1) and right slider (6-2) are used to clamp the protective shell (7-2) so that the positioning line on the protective shell (7-2) is aligned with the lower surface of the T-shaped through hole (6-10), while the crossbar (4) is embedded in the upper part of the T-shaped through hole (6-10); plastic screws are passed 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) respectively, and fixed with nuts; at the same time, plastic screws are passed through the first through hole (6-7) and the second through hole (6-8) and tightened to fix the relative position of the slider (6) and the crossbar (4); Insert the fixed crossbar (4), slider (6), and magnetic field measuring probe (7) into the brain gray matter equivalent solution in the thin spherical shell (1), so that the first threaded rod (5-1) and the second threaded rod (5-2) pass through the first round hole (4-1) and the second round hole (4-2) respectively; adjust the relative position of the slider (6) on the crossbar (4), and then adjust the relative height of the crossbar (4) and the threaded rod (5) so that the probe body (7-1) reaches the measurement position; finally, use plastic screws to pass through the first side round hole (4-3) and the second side round hole (4-4) respectively to fix the crossbar (4) on the first threaded rod (5-1) and the second threaded rod (5-2); attach the temperature measuring module (8) to the surface of the stimulation coil of the transcranial magnetic stimulation therapy device; Step 5: Set the stimulation sequence of the transcranial magnetic stimulation (TMS) device, start magnetic field and temperature detection, insert the stimulation coil of the TMS device into the first rectangular through hole (3-8) and make the center of the stimulation coil close to but not squeeze the thick spherical shell body (2-5). If it cannot be close, insert an acrylic plate into the first rectangular through hole (3-8) to raise the stimulation coil. Use the repetitive pulse stimulation mode. After the probe body (7-1) reaches the measurement position, measure the maximum magnetic induction intensity, spatial magnetic field distribution, output frequency, stimulation pulse width and coil surface temperature, and perform data analysis and uncertainty assessment on the measurement results.

6. The method for detecting the magnetic field and temperature of a transcranial magnetic stimulation therapy device according to claim 5, characterized in that: The method for preparing equivalent solutions of cerebrospinal fluid and cerebral gray matter uses pure water as the base material. Salts and sugars are added to adjust the conductivity and relative permittivity of the tissue equivalent solutions, making the conductivity and relative permittivity of the two equivalent solutions equivalent to those of real human cerebrospinal fluid and cerebral gray matter, respectively. The conductivity of real human cerebrospinal fluid is 1.00~2.51 S / m, and the relative permittivity is 109±30. The conductivity of real human cerebral gray matter is 0.06~2.47 S / m, and the relative permittivity is 85600±25000. All relative permittivity values ​​were measured and calibrated at a frequency of 2.8 kHz.

7. The method for detecting the magnetic field and temperature of a transcranial magnetic stimulation therapy device according to claim 5, characterized in that: The method for selecting the measurement position of the probe body (7-1) in step 4 of the method is as follows: the numerical models corresponding to the thin spherical shell (1) and the thick spherical shell (2) are imported into the simulation software, the conductivity and relative permittivity of the thin spherical shell (1) and the thick spherical shell (2) are assigned to the corresponding values ​​of the human skull, the space between the thin spherical shell (1) and the thick spherical shell (2) is assigned to the conductivity and relative permittivity of the cerebrospinal fluid, and the internal space of the thin spherical shell (1) is assigned to the conductivity and relative permittivity of the gray matter of the brain; then the circular stimulation coil and the figure-eight stimulation coil commonly used in transcranial magnetic stimulation therapy are abstracted and established as numerical models with their respective coil radius, number of turns and other geometric structural features, and the current intensity and current frequency parameters in the numerical model of the stimulation coil are assigned to the corresponding values ​​of the stimulation sequence in step 5 of claim 5; The magnetic field distribution inside the thin spherical shell (1) is obtained by calculation based on the finite element method when using different stimulation coils. For different stimulation coils, it is necessary to select a suitable measurement position according to the magnetic field distribution characteristics. Specifically, when measuring the maximum magnetic induction intensity, output frequency and stimulation pulse width of all stimulation coils, the probe body (7-1) should be placed at the lowest position inside the thin spherical shell (1). When measuring the magnetic field distribution inside the thin spherical shell (1), the appropriate spatial position coordinates, namely x coordinate, y coordinate and z coordinate, should be selected according to the structure 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 magnetic field distribution characteristics of different stimulation coils.

8. The method for detecting the magnetic field and temperature of a transcranial magnetic stimulation therapy device according to claim 7, characterized in that: In the spatial position x coordinate, y coordinate and z coordinate, the x coordinate is determined by the structure and position 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 slider (6) and the crossbar (4), and the z coordinate is determined by the depth of the probe body (7-1) inserted into the thin spherical shell (1).

9. A method for detecting the magnetic field and temperature of a transcranial magnetic stimulation therapy device according to claim 5, characterized in that: The method for positioning the probe body (7-1) measurement position in step 4 of the method is as follows: Before each measurement position is positioned, first adjust the relative position of the slider (6) on the crossbar (4), use a steel ruler to measure the distance between each side of the slider (6) and the end of the crossbar (4) on the same side, until the slider (6) is in the center position of the crossbar (4), then adjust the relative height of the crossbar (4) and the threaded rod (5) so that the end surface of the protective shell (7-2) coincides with the plane of the upper surface of the thin spherical shell edge (1-6); During 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 measurement position to determine the x coordinate; then the slider (6) is moved and the distance between each of its two sides and the end of the crossbar (4) on the same side is measured with a steel ruler until the target y coordinate is reached; the insertion depth of the probe 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 with a steel ruler until the target z coordinate is reached.

10. A method for detecting the magnetic field and temperature of a transcranial magnetic stimulation therapy device according to claim 5, characterized in that: The specific steps of magnetic field and temperature detection in step 4 of the method are described below. This includes: for any parameter and any measurement location, at least 6 consecutive measurements should be taken, and the average value should be taken as the final measurement result.

11. A method for detecting the magnetic field and temperature of a transcranial magnetic stimulation therapy device according to claim 5, characterized in that: The data analysis and uncertainty assessment in step 5 of the method includes the following steps: Step 5-1: Trace the steel ruler to the national length standard, trace the magnetic field measuring probe (7) to the national electromagnetic standard, and trace the temperature measuring module (8) to the national temperature standard to obtain the accuracy class, resolution or uncertainty of the above equipment; Step 5-2: For the obtained magnetic field strength measurement results or temperature measurement results, outliers are removed according to the Dickson criterion, and the standard deviation of the evaluated parameter is calculated based on the number of measurements. Step 5-3: Evaluate the uncertainty of the magnetic field strength measurement results or temperature measurement results. Based on the accuracy level, resolution or uncertainty obtained in Step 5-1, analyze the Type A standard uncertainty and Type B standard uncertainty introduced by the steel ruler, magnetic field measurement probe (7) and temperature measurement module (8). Then analyze the correlation of the above types of uncertainty and synthesize the expanded uncertainty to evaluate the reliability of the measurement results.

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