Electric field application method for head-mounted therapeutic device

Abstract

The present application provides an electric field application method for a head-mounted therapeutic device, the device including an electric field generating device, a cap body, a plurality of electrode buckles and a plurality of wires, the method including the following steps: Step 1. Determine a plurality of preliminary position assembly schemes of a plurality of electrode buckles on the cap body in three-dimensional space based on image data associated with a target area of ​​a subject and a skin surface condition; Step 2. Determine the optimal electrode buckle shape and size combination according to the various position assembly schemes of the electrode buckles on the cap body to form a plurality of groups of electrode buckle overall layout schemes; Step 3. Perform an electric field generation simulation according to each electrode buckle overall layout scheme to screen out a plurality of groups of electrode buckle overall layout schemes that can fully cover the target area, and select a group of electrode buckle overall layout schemes with the largest field strength in the target area as the final electrode buckle overall layout scheme; Step 4. Generate an optimal electric field application scheme based on the final electrode buckle overall layout scheme and in combination with the size and / or expansion direction of the target area.

Description

Technical Field

[0001] The present application relates to the field of medical technology, and in particular to a method for applying an electric field to a head-mounted therapeutic device. Background Art

[0002] Currently, the main treatments for tumors include surgery, radiotherapy, and chemotherapy, but all have corresponding disadvantages. For example, radiotherapy and chemotherapy can produce side effects and kill normal cells. Using electric fields to treat tumors is also one of the current research and development frontiers. Tumor electric field therapy uses a special electric field generator to generate a low-intensity, medium-high-frequency, alternating electric field to interfere with the mitotic process of tumor cells. Studies have shown that electric field therapy is effective in treating diseases such as glioblastoma, non-small cell lung cancer, and malignant pleural mesothelioma. The electric field applied by this treatment method can affect the aggregation of microtubules, prevent spindle formation, inhibit the mitotic process, and induce apoptosis in cancer cells.

[0003] Chinese Invention Patent Publication No. 114099958A discloses a tumor electric field therapy device for treating tumors. The device comprises an electric field generator and several electrode patches applied to the user's body surface. The electric field generator generates an alternating electrical signal and transmits it to the electrode patches, generating a therapeutic electric field between the electrode patches that is applied to the user's tumor. The electrode patch is equipped with multiple electrode units. Currently, most electrode patches have 9, 13, or 20 electrode units. Their structure is fixed and their size may not be suitable for all people. Moreover, when the electrode patch is applied to the user's head, the alternating electric field generated by the patch covers a wide area, easily exposing large areas of non-tumor areas to unnecessary electric fields, which can affect normal cells. Existing electrode patches need to be replaced after 2-3 days of use. Replaced electrode patches are discarded and cannot be reused. Existing electrode patches applied to non-planar surfaces, such as the user's head, can warp or become loosely adhered. This prevents the alternating electric field generated by the paired electrode patches from being applied to the target area, affecting the effectiveness of the electric field therapy for tumors. In addition, since the existing electrode patch is applied over a large area, the electric field will also be applied to the non-tumor area.

[0004] Therefore, there is a need to improve the electric field application method of the existing head-mounted therapeutic device. Summary of the Invention

[0005] The present application provides an electric field application method for a head-mounted treatment device that can accurately treat tumor sites.

[0006] Specifically, this application is implemented through the following technical solutions:

[0007] A method for applying an electric field to a head-mounted therapeutic device, the head-mounted therapeutic device comprising an electric field generating device, a cap body having a plurality of mounting holes, a plurality of electrode buckles cooperating with the mounting holes of the cap body, and a plurality of wires connecting the plurality of electrode buckles one by one to the electric field generating device, the electric field applying method comprising the following steps: Step 1. Determining a plurality of preliminary position assembly schemes of a plurality of electrode buckles on the cap body in three-dimensional space based on image data associated with a target area of ​​a subject and skin surface conditions; Step 2. Determining an optimal combination of electrode buckle shapes and sizes based on each of the position assembly schemes of the electrode buckles on the cap body to form a plurality of groups of electrode buckle overall layout schemes; Step 3. Performing an electric field generation simulation based on each of the electrode buckle overall layout schemes to screen out a plurality of groups of electrode buckle overall layout schemes that can fully cover the target area, and selecting a group of electrode buckle overall layout schemes with the largest field strength in the target area as the final electrode buckle overall layout scheme; Step 4. Generating an optimal electric field application scheme based on the final electrode buckle overall layout scheme and in combination with the size and / or expansion direction of the target area for applying a tumor treatment electric field.

[0008] According to one embodiment of the present invention, step 1 specifically includes: first inputting the user's brain image into computer simulation analysis software for reconstruction to obtain a three-dimensional model of the user's brain; if the user has undergone surgery, the user's surgery position is simultaneously marked on the virtual head model diagram of the computer simulation analysis software; then, the position of the mounting hole corresponding to the incision position is preferentially eliminated from the three-dimensional model of the user's brain containing the cap body, and the required electric field application area is determined around the tumor position and the incision position, and based on the required electric field application area, multiple preliminary position assembly schemes are formed for multiple electrodes buckled on the cap body.

[0009] According to an embodiment of the present invention, step 1 further includes: selecting a suitable position assembly scheme based on the electric field completely covering the tumor area and generating as many electric field transformation directions as possible.

[0010] According to one embodiment of the present invention, step 2 specifically includes: configuring the shape and size of the electrode buckles at each position based on a plurality of preliminary position assembly schemes to form a plurality of overall layout schemes of the electrode buckles.

[0011] According to one embodiment of the present invention, the electrode buckle also includes an electrode seat, and the optimal electrode buckle shape and size combination is achieved by selecting the shape and size of the electrode seat in combination with the head position of the mounting hole in the position assembly scheme and the curvature of the head position.

[0012] According to one embodiment of the present invention, the optimal combination of electrode buckle shape and size includes using the electrode buckle with a polygonal electrode seat at the corner position and using the electrode buckle with a circular electrode seat at the middle position.

[0013] According to one embodiment of the present invention, the final electrode buckle overall layout plan in step 3 is achieved by performing field strength analysis and selecting the layout plan with the largest field strength after using computer simulation analysis software to perform electric field generation simulation based on each of the electrode buckle overall layout plans, giving priority to excluding layout plans that generate electric fields but cannot fully cover the target area or are not focused enough, or layout plans that generate electric fields that cover too many non-tumor areas.

[0014] According to one embodiment of the present invention, step 4 specifically includes: the electric field generating device has an electrode interface corresponding one-to-one to the electrode buckle, and the electrode interface is electrically connected to the electrode buckle through the corresponding wire. Step 4 specifically includes: installing the electrode buckle in the corresponding mounting hole on the cap body according to the final electrode buckle overall layout plan, and connecting the electrode buckle with the corresponding electrode interface in the electric field generating device through the wire, and the electric field generating device applies the tumor treatment electric field to the target area according to the optimal electric field application plan.

[0015] According to one embodiment of the present invention, the generation of the optimal electric field application scheme in combination with the size and / or expansion direction of the target area in step 4 specifically involves allocating the duration of the electric field application in the X and Y directions in each cycle according to the size ratios of the target area in the X and Y directions.

[0016] According to one embodiment of the present invention, the generation of the optimal electric field application scheme in combination with the size and / or expansion direction of the target area in step 4 specifically involves allocating the duration of the electric field application in the X direction, Y direction, and B direction in each cycle based on the size ratios of the target area in the X direction, Y direction, and the diffusion direction of B.

[0017] According to one embodiment of the present invention, the electric field generating device includes a power supply system, an AC voltage generator, a switch array and an electrode interface. The AC voltage generator has L-phase and N-phase outputs, and each of the electrode interfaces is connected to the L-phase and the N-phase respectively through the switch array.

[0018] The electric field application method of the head-mounted treatment device of the present application can accurately apply the electric field to the tumor, reduce the electric field applied to non-tumor areas, and realize free switching of the direction of the electric field.

[0019] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is a perspective view of a head-mounted therapeutic device according to one embodiment of the present application;

[0021] Figure 2 for Figure 1 A schematic diagram of the distribution of mounting holes on the cap body of the head-mounted therapeutic device is shown;

[0022] Figure 3 for Figure 1 A schematic diagram of the distribution of electrode interfaces of an electric field generating device of a head-mounted therapeutic device is shown;

[0023] Figure 4 for Figure 1 The diagram shows the distribution of the mounting holes on the cap body on the user's head;

[0024] Figure 5 for Figure 1 A three-dimensional combined view of the electrode buckle of the head-mounted therapeutic device shown;

[0025] Figure 6 for Figure 5 Schematic diagram of the fixed cover of the electrode buckle shown;

[0026] Figure 7 for Figure 5 Schematic diagram of the electrode holder of the electrode buckle shown;

[0027] Figure 8 for Figure 7 A cross-sectional view of the electrode seat of the electrode buckle shown;

[0028] Figure 9 for Figure 6 A cross-sectional view of the fixed cover of the electrode buckle shown;

[0029] Figure 10 for Figure 1 A partial cross-sectional view of the head-mounted therapeutic device shown;

[0030] Figure 11 for Figure 1 a plan view of the conductor shown;

[0031] Figure 12 is a plan view of a guide wire of a head-mounted therapeutic device according to another embodiment of the present application;

[0032] Figure 13 This is a flow chart of the electric field application method of the head-mounted therapeutic device of the present application;

[0033] Figure 14 This is a flowchart of the electric field application process of the head-mounted therapeutic device of the present application;

[0034] Figure 15 A virtual head model image after scanning the user's tumor location and marking the surgical location;

[0035] Figure 16A To correspond Figure 15A schematic diagram of an electrode assembly array generated based on the user situation in the head-mounted therapeutic device of the present application and the cap mounting hole positions;

[0036] Figure 16B To correspond Figure 16A The electrode holder assembly information table of the electrode buckle with the cap body mounting hole;

[0037] Figure 17 A schematic diagram of the cap mounting holes for the head-mounted treatment device of this application is provided to prioritize the removal of tumor locations, mark the surgical locations, and integrate the cap mounting holes for the head-mounted treatment device of this application;

[0038] Figure 18 To correspond Figure 15 The first electrode assembly area plan is initially set according to the user situation in the;

[0039] Figure 19 To correspond Figure 15 The second electrode assembly area scheme is initially set according to the user situation in the;

[0040] Figure 20 for Figure 18 The schematic diagram of the assembly area corresponding to the first electrode assembly area scheme shown;

[0041] Figure 21 Schematic diagram of the electric field region between a pair of electrodes;

[0042] Figure 22 Schematic diagram of two electric field regions corresponding to the first and second electrode assembly area schemes;

[0043] Figure 23 To correspond Figure 15 Schematic diagram of the Y-direction electric field application of the optimal electric field set by the user in the embodiment;

[0044] Figure 24 To correspond Figure 15 Schematic diagram of the X-direction electric field application of the optimal electric field set by the user in the embodiment;

[0045] Figure 25 and Figure 15 Similarly, the diagram shows a virtual head model of the user after the tumor has spread;

[0046] Figure 26A To correspond Figure 25 Schematic diagram of the electrode assembly array generated by the tumor after diffusion;

[0047] Figure 26B To correspond Figure 26A Electrode assembly information table for the electrode holder of the electrode buckle of the electrode assembly array;

[0048] Figure 27 To correspond Figure 25Schematic diagram of the Y-direction electric field application of the optimal electric field set by the user in the embodiment;

[0049] Figure 28 To correspond Figure 25 Schematic diagram of the X-direction electric field application of the optimal electric field set by the user in the embodiment;

[0050] Figure 29 To correspond Figure 25 Schematic diagram of electric field application in direction B of the optimal electric field set by the user in the example;

[0051] Figure 30 A schematic diagram of the user's tumor size and development direction;

[0052] Figure 31 for Figure 1 The internal circuit block diagram of the electric field generating device shown;

[0053] Figure 32 for Figure 1 The switch array circuit block diagram of the electric field generating device shown.

[0054] Description of reference numerals:

[0055] Head-mounted therapeutic device 100, electric field generating device 1, power interface 11, interactive interface 12, electrode interface 13, housing 14, wire 2, plug 21, conductive sheet 22, contact portion 221, coil 22', cap body 3, cap body 31, side portion 311, avoidance hole 312, hollow hole 313, warp belt 314, weft belt 315, mounting hole 316, adjustment belt 32, electrode buckle 4, electrode seat 41, upper flange 411, middle flange 412, lower flange 413, connecting column 414, top 415, groove 416, card slot 4 17. Pit 418, fixing cover 42, top wall 421, side wall 422, bottom wall 423, through hole 4231, rib 4232, accommodating cavity 424, opening 425, limiting wall 426, through hole 4261, first limiting groove 427, second limiting groove 428, pressing portion 429, tumor positions 001, 001', blade position 002, assembly area 003, outer frame line 003A, inner frame line 003B, assembly coverable area 004, outer margin line 005, inner margin line 006, dividing line 007, tumor 008. DETAILED DESCRIPTION

[0056] Exemplary embodiments are described in detail herein, with examples illustrated in the accompanying drawings. When the following description refers to the drawings, identical numerals in different figures represent identical or similar elements unless otherwise indicated. The embodiments described in the following exemplary embodiments are not intended to represent all embodiments consistent with the present application. Rather, they are merely examples of devices, systems, apparatus, and methods consistent with certain aspects of the present application.

[0057] refer to Figure 1 As shown, the head-mounted treatment device 100 of the present application includes an electric field generating device 1, a plurality of wires 2, a cap body 3, and a plurality of electrode buckles 4 dispersedly arranged on the cap body 3. The electric field generating device 1 generates an alternating electric signal. The top side of the outer shell 14 of the electric field generating device 1 is provided with a power interface 11 and an interactive interface 12, and the side of the outer shell 14 is provided with a plurality of electrode interfaces 13. One end of the wire 2 is provided with a plug 21 that is plugged into the electrode interface 13, and the other end is provided with a conductive sheet 22 that is in contact with and conductive to the electrode buckle 4 on the cap body 3. The cap body 3 is worn on the user's head, and the plurality of wires 2 transmit the alternating electric signal generated by the electric field generating device 1 to the electrode buckle 4 through the wire 2, so that an alternating electric field is generated between the plurality of electrode buckles 4 and electric field treatment is performed on the tumor on the user's head.

[0058] The cap body 3 includes a cap body 31 that covers the user's head and an adjusting strap 32 connected to both sides of the bottom of the cap body 31. The length of the adjusting strap 32 is adjustable so that the cap body 31 can be in close contact with the user's head, thereby adapting to different users. Preferably, the adjusting strap 32 is made of comfortable fabric. The left and right sides of the cap body 31 are respectively provided with a side portion 311 extending downward from its bottom edge, and the side portion 311 is provided with a avoidance hole 312 for avoiding the user's ears, and the two ends of the adjusting strap 32 are respectively connected to the bottom of the two side portions 311. As a simple transformation, the side portion 311 can also be provided by the adjusting strap 32, and the adjusting strap 32 is directly connected to the bottom edge of the cap body 31.

[0059] The cap body 31 is provided with a plurality of hollow holes 313 to improve the heat dissipation performance of the cap body 31. The cap body 31 is divided by the plurality of hollow holes 313 to form a plurality of crisscrossing warp strips 314 and weft strips 315. The cap body 31 is provided with a plurality of mounting holes 316 for fixing the electrode buckle 4. The plurality of mounting holes 316 can be distributed on each weft strip 315, or on each warp strip 314, or on both the weft strip 315 and the warp strip 314. In the present application, the mounting holes 316 are distributed on both the weft strip 315 and the warp strip 314, and the mounting holes 316 are located at the connection between each weft strip 315 and each warp strip 314. The cap body 31 is made of elastic material, such as silicone, stretch cloth, etc. In this application, silicone material is preferred to make the cap body 31 elastic, so that the electrode buckle 4 can be smoothly and closely contacted with the user's head after being assembled into the mounting hole 316 of the cap body 31, so as to ensure the effective transmission of the alternating electrical signal and facilitate cleaning.

[0060] refer to Figure 3 and Figure 4 As shown, combined with Figure 1As shown, each electrode buckle 4 is independently connected to the corresponding electrode interface 13 of the electric field generating device 1 using a single wire 2, and all electrode buckles 4 are independently controlled in parallel. The electrode interface 13 on the electric field generating device 1 corresponds to the mounting hole 316 on the cap body 3. For ease of understanding, Figure 4 and Figure 5 The electrode interface 13 and the mounting hole 316 are marked accordingly. For example, if the plug 21 at one end of the wire 2 is inserted into the electrode interface 13 marked as A0, the conductive piece 22 at the other end of the wire 2 needs to be electrically connected to the electrode buckle 4 located at the mounting hole 316 marked as A'0 on the cap body 3; if the plug 21 at one end of the wire 2 is inserted into the electrode interface 13 marked as A-5, the conductive piece 22 at the other end of the wire 2 needs to be electrically connected to the electrode buckle 4 located at the mounting hole 316 marked as A'-5 on the cap body 3, so as to ensure that the electrode interface 13 and the electrode buckle 4 located at the corresponding mounting hole 316 on the cap body 3 are electrically connected through the wire 2, and by controlling the current on and off of the relevant electrode interface 13, the application of the alternating electrical signal to the electrode buckle 4 at the corresponding mounting hole 316 on the cap body 3 is controlled.

[0061] refer to Figure 2 As shown, the coverable area of ​​the cap body 3 is the arc-shaped area from the "root of the nose" to the "occipital protuberance" of the user's head. At the same time, in view of comprehensive considerations such as the head structure, brain position, and comfort, about 80% of the upper side of the arc-shaped area is defined as the coverable area that can be covered by the mounting hole 316, and the coverable area is equally divided into 10 sub-areas, and the mounting holes 316 are densely arranged in each sub-area, and each mounting hole 316 is respectively set at a different position on the head.

[0062] By determining the area where the alternating electric field is applied, the electrode interface 13 that needs to be turned on is selected, and the alternating electric signal generated by the electric field generating device 1 is selectively transmitted to the electrode buckles 4 at different positions of the cap body 3. For example, if the user's tumor is located at the back of the brain, it is only necessary to install the relevant electrode buckles 4 that can apply the alternating electric field to the back of the brain, and in combination with the correspondence between the electrode interface 13 and the position of the electrode buckle 4, the relevant electrode interface 13 is selected to be turned on, while the relevant electrode interface 13 corresponding to the relevant electrode buckle 4 on the area covering other areas on the cap body 3, such as the forehead, is selected not to be turned on. Compared with the whole-piece electrode patch, the present application can flexibly select the relevant electrode buckles 4 that need to work, and carry out more targeted treatment.

[0063] The operating steps of the head-mounted treatment device 100 for electric field therapy are as follows: 1. Generate an electrode assembly array, and the computer obtains CT or MRI images of the user's brain or other forms of brain image data, and then analyzes a series of factors such as the location and size of the tumor in the user's brain to provide the optimal electrode assembly array; 2. Install the electrode buckle 4, and according to the electrode assembly array output by the computer, install multiple electrode buckles 4 on the mounting holes 316 of the cap body 3; 3. Set the wire 5, insert the conductive piece 22 of the wire 2 into the electrode buckle 4, and insert the plug 21 of the wire 2 into the corresponding electrode interface 13 of the electric field generating device 1; 4. Wear the cap body 3 with the electrode buckle 4 installed and the wire 2 connected on the user's head, and the connection environment of the entire system is completed. The user can then turn on the head-mounted treatment device 100 to start tumor electric field therapy.

[0064] refer to Figures 5 to 10 As shown, the specific structure of the electrode buckle 4 is described below.

[0065] In this embodiment, the electrode buckle 4 is generally cylindrical and includes a fixed cover 42 and an electrode holder 41 that are buckled together. The electrode holder 41 is made of a dielectric material and is used as a dielectric element to isolate direct current from alternating current. The electrode holder 41 is an integrally formed ceramic material, and the fixed cover 42 is made of an elastic and insulating material. The fixed cover 42 is fixed on the electrode holder 41 and cooperates with the electrode holder 41 to fix the conductive sheet 22. The electrode holder 41 has an upper flange 411, a middle flange 412, a lower flange 413 and a connecting column 414 connecting the three. The upper flange 411, the middle flange 412 and the lower flange 413 are all disc-shaped and are arranged concentrically from top to bottom. The connecting column 414 is generally cylindrical, and the upper flange 411, the middle flange 412 and the lower flange 413 are arranged around the connecting column 414. The portion of the connecting column 414 exposed from the upper flange 411 forms a top 415. A groove 416 surrounding the connecting post 414 is formed between the upper flange 411 and the middle flange 412, while a slot 417 surrounding the connecting post 414 is formed between the middle flange 412 and the lower flange 413. The metal conductive sheet 22 is inserted into the electrode buckle 4 and does not contact the user's head. The ceramic electrode base 41 directly contacts the user's scalp, eliminating metal toxicity or biocompatibility issues and eliminating the need for conductive gel.

[0066] The bottom surface of the lower flange 413 of the electrode holder 41 directly contacts the user's scalp. Considering the varying curvatures of different locations on the user's head surface, the lower flange 413 can be of various shapes and sizes. In this embodiment, the lower flange 413 of the electrode holder 41 is circular. In other embodiments, the lower flange 413 of the electrode holder 41 can also be square, hexagonal, or other shapes. Electrode holders 41 with differently shaped lower flanges 413 can be adapted to different locations on the user's head. Furthermore, electrode holders 41 with the same lower flange 413 can also be provided in a variety of different sizes to accommodate users with different head sizes. For example, multiple electrode holders 41 can each have a circular lower flange 413, each with a large, medium, or small diameter size for user selection. Designing the lower flange 413 of the electrode holder 41 in different shapes and / or sizes provides users with a wider range of options to accommodate different parts of the user's head, ensuring close contact between the user's head and the lower flange 413 of the electrode holder 41, thereby ensuring stable application of the alternating electrical signal.

[0067] The fixed cover 42 includes a top wall 421, side walls 422 located around the top wall 421, and a bottom wall 423 located around the bottom of the side wall 422. The top wall 421, side walls 422, and bottom wall 423 collectively form a receiving cavity 424. An opening 425 is formed through the side wall 422 near the top wall 421. The fixed cover 42 also includes a retaining wall 426 located within the receiving cavity 424. The retaining wall 426 is an annular wall with a peripheral edge connected to the side wall 422. The top surface of the retaining wall 426 is flush with the bottom surface of the opening 425. A first retaining groove 427 communicating with the opening 425 is formed between the retaining wall 426 and the top wall 421, and a second retaining groove 428 is formed between the retaining wall 426 and the bottom wall 423. A through hole 4231 is provided at the center of the bottom wall 423. The diameter of through hole 4231 is smaller than the diameter of the upper flange 411 and is close to the diameter of the connecting post 414 of the electrode holder 41. A through hole 4261 is provided at the center of the limiting wall 426. The diameter of through hole 4261 is smaller than the diameter of the upper flange 411 and is close to the diameter of the connecting post 414.

[0068] Combine Figure 10As shown, when assembling the electrode holder 41 and the fixing cover 42, the top 415 of the electrode holder 41 is inserted into the through hole 4231 and the fixing cover 42 is pressed downward. Since the fixing cover 42 is made of an elastic material, the through hole 4231 expands outward to allow the upper flange 411 of the electrode holder 41 to be snapped into the second limiting groove 428 of the fixing cover 42. The limiting walls 426 and bottom wall 423 of the fixing cover 42 tightly clamp and fix the upper flange 411 of the electrode holder 41 from top to bottom, thereby fixing the fixing cover 42 to the electrode holder 41. The bottom wall 423 also has a rib 4232 located on its upper surface and arranged around the through hole 4231 to abut the upper flange 411, which is used to increase the clamping force of the limiting walls 426 and bottom wall 423 on the upper flange 411. After assembly, the top portion 415 of the electrode holder 41 extends upwardly through the through-hole 4261 of the fixed cover 42, and the top surface of the top portion 415 is coplanar with the top surface of the retaining wall 426. The bottom wall 423 of the fixed cover 42 is located within the groove 416 of the electrode holder 41. The height of the groove 416 is greater than the thickness of the bottom wall 423 to prevent interference between the groove 416 and the bottom wall 423, which could affect the assembly of the electrode holder 41 and the fixed cover 42.

[0069] refer to Figure 10 and Figure 11 As shown, the conductive sheet 22 is electrically connected to the wire core (not shown) in the wire 2 and is securely fixed to one end of the wire 2. The conductive sheet 22 is roughly in the shape of a disc and is completely exposed to the wire 2. The size of the opening 425 is larger than the diameter of the conductive sheet 22. The conductive sheet 22 can be inserted into the first limiting groove 427 inside the fixed cover 42 from the opening 425 of the fixed cover 42. The limiting wall 426 of the fixed cover 42 and the top 415 of the electrode seat 41 are used to support and guide the conductive sheet 22 to be inserted smoothly. When the front end of the conductive sheet 22 contacts the side wall 422 of the fixed cover 42 located on the side of the accommodating cavity 424, it means that the conductive sheet 22 has been assembled in place. The conductive sheet 22 is connected to the electrode buckle 4 in a plug-in manner to facilitate the removal of the wire 2 when the electrode buckle 4 needs to be replaced.

[0070] Since the mutual contact between the conductive sheet 22 and the electrode holder 41 will generate contact impedance, the higher the degree of fit between the conductive sheet 22 and the electrode holder 41 and the smaller the gap, the smaller the contact impedance will be. In this embodiment, the center of the conductive sheet 22 is punched downward to form a downwardly protruding arc-shaped contact portion 221, and the center of the top 415 of the electrode holder 41 is provided with a downwardly recessed arc-shaped pit 418 corresponding to the contact portion 221, and the center of the top wall 421 of the fixed cover 42 is provided with a downwardly protruding arc-shaped pressing portion 429 corresponding to the contact portion 221. The pressing portion 429 presses the contact portion 221 against the inner wall surface of the pit 418 to ensure that the conductive sheet 22 and the electrode holder 41 are tightly fitted, reducing the contact impedance and ensuring the application effect of the alternating electrical signal. In other embodiments, the center of the conductive sheet 22 can also be other shapes. The key point is to be in close contact to reduce the contact impedance.

[0071] When assembling the electrode buckle 4, the electrode holder 41 is inserted into the mounting hole 316 from the inside of the cap body 31. The diameter of the mounting hole 316 is slightly smaller than or equal to the diameter of the connecting column 414 of the electrode holder 41, and smaller than the diameters of the upper flange 411, the middle flange 412 and the lower flange 413. Since the cap body 31 is made of elastic material, during the process of the electrode holder 41 being inserted into the mounting hole 316 from the inside of the cap body 31, the mounting hole 316 expands outward so that the upper flange 411 and the middle flange 412 of the electrode holder 41 pass through the mounting hole 316 in turn. The edge of the warp band 314 or the weft band 315 of the cap body 3 located on the side of the mounting hole 316 is inserted into the slot 417 between the middle flange 412 and the lower flange 413, and the lower flange 413 remains on the inner side of the cap body 31, so that the electrode holder 41 can be reliably fixed on the cap body 31. Among them, the height of the card slot 417 is close to the thickness of the cap body 31, which prevents the electrode seat 41 from shaking on the cap body 31. The diameter of the lower flange 413 is much larger than the diameter of the mounting hole 316, thereby preventing the lower flange 413 from detaching from the mounting hole 316. After fixing the electrode seat 41, the fixing cover 42 is fixed to the electrode seat 41 by pressing. The conductive sheet 22 can be inserted into the electrode buckle 4 after the fixing cover 42 is fixed to the electrode seat 41, or it can be inserted into the fixing cover 42 first and then fixed to the electrode seat 41 together with the fixing cover 42. When removing the electrode buckle 4 from the cap body 31, first pull the fixing cover 42 upwards to separate the fixing cover 42 from the electrode buckle 4, and then pull the electrode seat 41 downwards.

[0072] The cap body 3 and electrode buckle 4 of the head-mounted therapeutic device 100 are washable. Because the electrode buckle 4 is secured to the cap body 3 using a snap-fit ​​assembly, it can be removed from the cap body 3 for separate cleaning. High-temperature steam sterilization is preferred, making the electrode buckle 4 reusable and reducing costs. The silicone cap body 31 can be washed directly with water. Both operations can be performed by the user at home.

[0073] refer to Figure 12The present application also provides another embodiment of a head-mounted therapeutic device, which is basically the same as the head-mounted therapeutic device 100 of the previous embodiment, with the only difference being that the material of the electrode holder 41 of the electrode buckle 4 is replaced with a magnetic conductor, which has the function of concentrating magnetism and enhancing the magnetic field. Preferably, the following materials are used: iron silicon aluminum, manganese-zinc, nickel-zinc, permalloy, etc. Correspondingly, the conductive sheet 22 at one end of the wire 2 is replaced with a coil 22', and two wire cores (not shown) are provided in the wire 2. The two wire cores (not shown) connect the coil 22' to the electric field generating device 1 and form a closed loop. The alternating electric signal of the electric field generating device 1 is transmitted to the electrode buckle 4 through the coil 22', forming an alternating magnetic field in the electrode buckle 4, and then forming an alternating electric field in a direction perpendicular to the plane where the electrode buckle 4 is located, ultimately achieving the treatment of the tumor by the alternating electric field. In the present application, the coil 22' and the conductive sheet 22 can be collectively referred to as the conductive part.

[0074] The head-mounted therapeutic device 100 of the present application comprises a cap body 3 and a plurality of electrode buckles 4 distributed on the cap body 3. The conductive sheet 22 or coil 22' that energizes the electrode buckles 4 is connected to the electrode buckles 4 by plugging, facilitating the removal of the wires 2 when replacing or cleaning the electrode buckles 4. The electrode buckles 4 are fixed to the cap body 3 by a snap-fit ​​assembly, allowing for easy removal, replacement, and cleaning. The positions of the electrode buckles 4 can be flexibly adjusted to suit the needs of different users and can be reused repeatedly, reducing usage costs.

[0075] refer to Figure 13 Combined with Figure 14 As shown, in order to achieve precise application of electric fields, free switching of directions, and cancellation of unnecessary electrode buckles 4, the present application provides the following electric field application method for the head-mounted treatment device 100, which includes the following steps: Step 1. Determine multiple preliminary position assembly schemes of multiple electrode buckles on the cap body in three-dimensional space based on the image data associated with the target area of ​​the subject and the skin surface condition; Step 2. According to each of the position assembly schemes of the electrode buckles on the cap body, determine the optimal electrode buckle shape and size combination to form a plurality of groups of electrode buckle overall layout schemes; Step 3. Perform electric field generation simulation according to each of the electrode buckle overall layout schemes to screen out multiple groups of electrode buckle overall layout schemes that can fully cover the target area, and select a group of electrode buckle overall layout schemes with the largest field strength in the target area as the final electrode buckle overall layout scheme; Step 4. Based on the final electrode buckle overall layout scheme, combined with the size and / or expansion direction of the target area, generate the optimal electric field application scheme for applying the tumor treatment electric field.

[0076] The aforementioned steps 1 to 3 specifically involve first inputting the user's brain images, including but not limited to CT or MRI images, into the computer simulation analysis software by scanning, and simultaneously marking the user's surgical location on the virtual head model diagram of the computer simulation analysis software. If the user has not undergone surgery, it can be omitted; the computer simulation analysis software will combine a series of information such as the tumor location, tumor area, tumor depth, incision location, incision area, etc. in the user's image to analyze the most appropriate electrode assembly method. After the computer simulation analysis is completed, it will output: the electrode assembly array. The electrode assembly array is a drawing document on which the mounting holes 316 where the electrode buckles 4 need to be installed are marked on the cap body 3, and the size and shape of the electrode buckles 4 required to be installed in the corresponding mounting holes 316 are marked. The electrode assembly array is the final electrode buckle overall layout plan in the above step 3. The user will correctly install the electrode buckle 4 according to the information provided by the electrode assembly array. The electrode buckle 4 is then connected to the electric field generating device 1. Specifically, the aforementioned step 4 is that after the output electrode assembly array is assembled, the computer simulation analysis software will also output the optimal electric field application plan, connect the electric field generating device 1 to the computer through a data transmission line, and transmit the optimal electric field application plan just obtained to the electric field generating device 1 through the data interaction software. After that, the optimal electric field application plan of the user is stored in the electric field generating device 1. Thereafter, as long as the user turns on the head-mounted treatment device 100 for electric field treatment, the electric field applied will be applied according to the optimal electric field application plan.

[0077] After the user's brain image scan is input and the user's incision position is marked, the computer simulation analysis software will display something like Figure 15 The image shown, Figure 15 The outer circle in the figure represents the outline of the brain from above, with the inner circle marking the tumor location 001, identified through imaging, and the incision location 002, indicated by annotation. Computer simulation software analyzes a series of information, including tumor location, size, depth, incision location, and area, to output the electrode assembly array and the optimal electric field application plan. The following describes the electrode assembly array.

[0078] The process of formulating the electrode assembly array (i.e., the final electrode buckle overall layout plan) in the aforementioned step 3 includes: first finding the corresponding tumor position 001 and blade position 002 in the array, determining the required electric field application area around the tumor position 001 and blade position 002, and forming a preliminary electrode buckle 4 assembly area (i.e., preliminary position assembly plan) for the required electric field application area, and then determining the electrode buckle 4 configuration plan based on the preliminary electrode buckle 4 assembly area, mainly the shape and size of the electrode seat 41; combining the assembly area and the electrode buckle 4 configuration selection to form the optimal electric field combination plan, determine the final electrode buckle 4 overall layout plan, and output the electrode assembly array with the optimal electrode buckle 4 configuration.

[0079] Figure 16A This is an example of an electrode assembly array output by computer simulation analysis software. The tumor location 001 marked on it is the location of the user's brain tumor, and the incision location 002 is the location of the incision after the user's surgery is completed and healed. If the user has not undergone surgery, there is no incision location. The quadrilateral ring frame surrounding the tumor location 001 and the incision location 002 is the assembly area 003 of all the electrode buckles 4 that need to be assembled, calculated by the computer simulation analysis software. The outer frame line of the assembly area 003 is 003A, and the inner frame line of the assembly area 003 is 003B. After obtaining the assembly area 003 of the electrode buckle 4, the computer simulation analysis software calculates the configuration information of the electrode buckle 4 that each mounting hole 316 should be adapted to, based on the different positions of the user's head and the maximum area of ​​the electric field covering the tumor site. That is, what shape and size of the electrode seat 41 should be configured. The process will be described in detail below.

[0080] The first step is to form the preliminary assembly area of ​​the electrode buckle 4: Figure 17 As shown, when determining the configuration area 003, the tumor position 001 and the incision position 002 are first eliminated. Figure 16A For example, the mounting holes 316 at locations marked A'0, A'+1, B'0, and B'+1 are excluded and do not require the installation of the electrode buckle 4. The main reason for this arrangement is that A'0 and B'0 are located within the area of ​​tumor location 001. Typically, before electric field therapy, the user's tumor is surgically removed. After the tumor is removed, the resected area is often filled with cerebrospinal fluid, resulting in a depression at A'0 and B'0 on the user's head. Therefore, it is difficult to ensure close contact between the electrode buckle 4 and the user's skin when installing it at tumor location 001. Therefore, the mounting point at tumor location 001 is preferentially discarded during computer simulation analysis software processing.

[0081] Similarly, incision position 002 was also discarded because electric field therapy requires prolonged wear. Typically, users begin electric field therapy shortly after tumor removal surgery, and the wound may not be fully healed at the start of treatment. Therefore, installing electrodes at positions A'+1 and B'+1 would interfere with incision position 002, potentially preventing wound healing or causing infection. Even if the wound heals, the healed scar at incision position 002 will be uneven, making it difficult to ensure close contact between electrode buckle 4 and the user's skin. For these reasons, the computer simulation analysis software prioritizes installing electrode buckle 4 at tumor position 001 and incision position 002.

[0082] After eliminating tumor location 001 and surgical location 002, the computer simulation analysis software begins the next step of measurement and analysis, selecting the appropriate electrode assembly area, and striving to ensure that the final applied electric field can generate as many electric field changeable directions as possible within the 360-degree direction of the tumor, so as to achieve full coverage of the tumor and changeable direction of the electric field. Figure 18 and Figure 19 The example of electric field lines shown in FIG. 1 is an example of the multiple directional electric fields that can be generated by the electrode assembly array. Based on the above conditions, the computer simulation analysis software can determine the various assembly areas of the electrode buckle 4 required by the user, thus completing the multiple preliminary position assembly plans for the electrode buckle 4 in step 1.

[0083] Next, determine the configuration scheme of the electrode buckle 4. After completing the above steps, the computer simulation analysis software obtains the preliminary position assembly scheme of multiple electrode buckles 4, such as Figure 18 and Figure 19 As shown. For each electrode buckle 4 position assembly scheme, in addition to knowing the mounting holes 316 that need to be covered, it is also necessary to determine the type of electrode holder 41 of the electrode buckle 4 that each mounting hole 316 needs to be installed. Figure 17 Take the installation hole in the example as an example to illustrate. Figure 20 As shown, the computer simulation analysis software will analyze and calculate the maximum area of ​​the electrode buckle 4 that can be assembled in each mounting hole 316. Figure 20 The maximum size area of ​​the electrode holder 41 that can be assembled with the C'+2 mounting hole 316 is the assembly coverage area 004. After determining the size of the assembly coverage area 004, the computer simulation analysis software will retrieve the electrode holder 41 with the largest matching area in the database. Of course, in addition to considering the maximum coverage of the assembly coverage area, the position and curvature of the head where the mounting hole 316 is located will also be considered during the calculation. This ensures that the preferred electrode buckle 4 covers this area as much as possible while also ensuring that the selected electrode buckle 4 can adapt to the curvature of the head corresponding to the mounting hole 316, so as to ensure that the electrode buckle 4 is tightly attached to the head. For example Figure 16A and Figure 16B As shown in FIG, a large, hexagonal electrode holder 41 can be used at the mounting hole 316 marked as C'+2.

[0084] The division of the assembly coverage area of ​​each mounting hole 316 is mainly carried out by dividing it by the outer margin line 005, the inner margin line 006, and the dividing line 007. Among them, the outer margin line 005 is the maximum margin line that the selected mounting hole area can expand to the next mounting hole 316, the inner margin line 006 is the smallest inner expansion margin line in the selected mounting hole area, and the dividing line 007 is the area dividing line divided by the equal division principle. In this example, the electrode seat 41 of the electrode buckle 4 includes a circle and a polygon, so as to select the electrode seat 41 that matches it for different assembly areas, among which the electrode buckle 4 located at the corner position mostly selects the polygonal electrode seat 41, and the electrode buckle 4 located in the middle position mostly selects the circular electrode seat 41. Based on the above, the computer simulation analysis software matches the optimal electrode buckle 4 configuration scheme for each electrode buckle 4 position assembly scheme, forming a multi-group electrode buckle 4 overall layout scheme, and the aforementioned step 2 is completed.

[0085] Next, the electric field optimization analysis is carried out. The computer simulation analysis software further performs focus and coverage analysis based on the previously calculated layout of multiple sets of electrode buckles 4. The screening principle is focus and coverage, which is mainly to ensure that the selected overall layout plan, after the electrode buckles 4 are installed, can fully focus and cover the tumor when the electric field is applied in all directions. Figure 21 As shown, two electrode clips 4, installed in two mounting holes 316, generate a regional electric field between them. The electric field lines E of this regional electric field must fully cover the tumor 008. Furthermore, due to the size limitations of the electrode base 41 of the electrode clips 4, they also provide a focusing function, ensuring that the electric field covers as few areas as possible without the tumor. Based on these two principles, the computer simulation analysis software prioritizes and excludes the following overall layout options: 1. Layout options that generate an electric field that does not fully cover the tumor or is insufficiently focused; 2. Layout options that generate an electric field that covers too much non-tumor area.

[0086] Next, the field strength optimization analysis is carried out. After eliminating the above analysis, the final electrode buckle overall layout scheme is determined. The main purpose is to conduct a final field strength analysis on multiple sets of electrode buckle overall layout schemes that meet the requirements of the above steps. Under the same voltage, analyze and confirm which overall layout scheme can produce a greater field strength at the tumor location. For example, for Figure 18 and Figure 19 The two schemes shown are compared in terms of the field strength generated at each position, and the one with the largest field strength under the same applied voltage is selected as the best. Figure 22As shown, the mounting hole 316 marked as A'+2 corresponds to position 011, the mounting hole 316 marked as A'-1 corresponds to position 012, and the mounting hole 316 marked as A'-2 corresponds to position 013. The electric field coverage area generated from the mounting hole 316 marked as A'+2 to the mounting hole 316 marked as A'-1 is defined as field area 1, and the electric field coverage area generated from the mounting hole marked as A'+2 to the mounting hole marked as A'-2 is defined as electric field area 2. Figure 22 It can be seen that the electric fields generated by these two areas can both cover the tumor 008. However, from the perspective of the distance between the electrodes, it is obvious that the distance between the mounting hole 316 marked as A'+2 and the mounting hole marked as A'-1 is smaller than the distance between the mounting hole 316 marked as A'+2 and the mounting hole 316 marked as A'-2. According to the basic physical field strength formula E=U / d, the smaller the distance between the electrodes, the greater the field strength generated under the same voltage. Therefore, from the perspective of maximizing the field strength under the same applied voltage, Figure 18 The electrode assembly scheme in Figure 19 The electrode assembly scheme in the system is determined Figure 18 The electrode assembly scheme in is the final overall layout scheme of the electrode buckle, and the electrode assembly array is output.

[0087] Next, we'll explain in detail another file output by the computer simulation analysis software: the optimal electric field application plan. This optimal electric field application plan is the optimal electric field control method calculated by the computer simulation analysis software. This method is transmitted to the electric field generating device 1 via a data cable. This optimal electric field control method is then stored within the electric field generating device 1. Each time the user activates the electric field, the electric field generating device 1 will apply the electric field to the user according to this stored optimal electric field control method, achieving optimal and precise electric field control.

[0088] Refer to Table 1, which is the analysis of the optimal electric field application scheme, that is, the computer simulation analysis software is based on Figure 15 The optimal electric field application scheme is finally calculated. Specifically, assuming that the time period of applying the electric field to the user is T, then during the period T, the electric field is applied in two directions, namely the Y direction (refer to Figure 23 ) and X direction (refer to Figure 24), wherein the electric field application period in the Y direction is 0.6T, which is achieved by connecting the electrode buckles 4 at the mounting holes 316 marked as C'-1, C'0, C'+1, and C'+2 to the L phase of the electric field generating device 1 at time 0, and connecting the electrode buckles 4 at the mounting holes 316 marked as G'-1, G'0, G'+1, and G'+2 to the N phase of the electric field generating device 1. There is no electrical connection between the electrode buckles 4 at the remaining mounting holes 316 and the electric field generating device 1. After the connection is completed, the electric field generating device 1 starts to apply AC voltage for a time of 0. 0.6T; then, at 0.6T, all connected electrode clips 4 at mounting holes 316 were disconnected. The electrode clips 4 at mounting holes 316 labeled C'-1, B'-1, A'-1, and G'-1 were then connected to the L phase of the electric field generator 1, and the electrode clips 4 at mounting holes 316 labeled C'+2, B'+2, A'+2, and G'+2 were connected to the N phase of the electric field generator 1. This switched the direction to the X direction. An AC voltage was then applied in this direction for 0.4T, completing the electric field application for the entire T cycle. The electric field was then applied repeatedly in a controlled manner with a duration of T. Given that the tumor was primarily concentrated in the Y direction and had a larger volume in that direction, the computer simulation analysis software determined the optimal application schedule based on information such as the most likely direction of tumor spread: a 0.6T electric field cycle in the Y direction and a 0.4T electric field cycle in the X direction.

[0089] Table 1: Optimal electric field application scheme

[0090]

[0091] If the user finds that his tumor has spread from its original location during the next medical imaging examination, assuming that the virtual head model after scanning and marking by computer simulation analysis software is as follows Figure 25 As shown, from Figure 25 It can be clearly observed that the tumor area is larger than that of the tumor position 001' Figure 15 The tumor location 001 in the image has expanded, and the computer simulation analysis software has analyzed its possible spread direction. Figure 25 The tumor diffusion direction A (consistent with the X-axis direction) or the tumor diffusion direction B (about 45° counterclockwise angle with the X-axis) shown in the figure is used. The computer simulation analysis software will generate a new electrode assembly array and the optimal electric field application scheme. The new electrode assembly array and electrode base assembly information table is as follows: Figure 26A and Figure 26B As shown, since the tumor has only slightly spread to the mounting hole 316 position marked as B'+1, Figure 26A The optimal electrode assembly array in the basic and Figure 16AThe results are consistent with those in the previous section, except that the corresponding optimal electric field application schemes are different.

[0092] Table 2 shows the optimal electric field application scheme of another embodiment. Specifically, assuming that the time period of applying the electric field to the user is T, then within the time period T, the electric field is applied in three directions, namely, the Y direction (refer to Figure 27 ), X direction (refer to Figure 28 ), B direction (refer to Figure 29 ), wherein the electric field application period in the Y direction is 0.3T, which is achieved by connecting the electrode buckles 4 at the mounting holes 316 marked as C'-1, C'0, C'+1, and C'+2 to the L phase of the electric field generating device 1 at time 0, and connecting the electrode buckles 4 at the mounting holes 316 marked as G'-1, G'0, G'+1, and G'+2 to the N phase of the electric field generating device 1, and not making any connection to the electrode buckles 4 at the other irrelevant mounting holes 316. After the connection is completed, the AC voltage is applied for a time of 0.3T. Then, at the 0.3T moment, all connected electrode buckles 4 are disconnected, and then the electrode buckles at the mounting holes 316 marked as C'-1, B'-1, A'-1, and G'-1 are connected to the L phase of the electric field generating device 1, and the electrode buckles 4 at the mounting holes 316 marked as C'+2, B'+2, A'+2, and G'+2 are connected to the N phase of the electric field generating device 1, thereby switching the direction to the X direction, and then applying an AC voltage for 0.3T in this direction. Then, at 0.6T (0.6T=0.3T+0.3T), all connected electrode buckles 4 are disconnected, and then the electrode buckles 4 at the mounting holes 316 marked as B'-1, A'-1, G'-1, G'0, and G'+1 are connected to the L phase of the electric field generating device 1, and the electrode buckles 4 at the mounting holes 316 marked as C'0, C'+1, C'+2, B'+2, and A'+2 are connected to the N phase of the electric field generating device 1. This switches the direction to the B direction (approximately 45° counterclockwise with the X-axis), and then applies an AC voltage for 0.4T in this direction, completing the application of the electric field within the entire T period. Thereafter, the electric field is applied repeatedly according to the control method of the T period. The computer simulation analysis software arranged the application time based on the current direction of tumor spread and the size of the tumor in the relevant directions, that is, an electric field with a period of 0.3T was applied in the Y direction, an electric field with a period of 0.3T was applied in the X direction, and an electric field with a period of 0.4T was applied in the B direction.

[0093] Table 2: Information and instructions for the optimal electric field application plan after tumor location spread

[0094]

[0095]

[0096] Thus, the present application achieves precise electric field application and eliminates unnecessary electrodes. The aforementioned free switching of directions is primarily achieved by the internal circuitry of the electric field generating device 1 , primarily by adding an electric field application in the same direction as the tumor growth trend, and determining the selection of the mounting hole 316 based on the newly added electric field application direction.

[0097] The computer simulation analysis software mainly analyzes the development direction of the tumor and the size of the tumor in each direction to determine the direction of electric field application and the time period of electric field application in each direction. Figure 30 Regarding tumor location 001', there are two primary directions of tumor development: tumor development direction 1 and tumor development direction 2. The computer simulation analysis software prioritizes the application of the electric field in two directions: tumor development direction 1 (i.e., the horizontal direction in the diagram) and tumor development direction 2 (i.e., the vertical direction in the diagram). Furthermore, the software determines whether each mounting hole 316 is in the L or N phase based on the previously determined electrode assembly array to ensure the system can smoothly output the electric field in both directions. After determining the direction of electric field application, it is also necessary to determine the time for applying the electric field in each direction of electric field application. The system sets the time period for applying the electric field to T, which is usually preferably T=1s, and the system will measure the maximum size of the tumor in tumor development direction 1 and define it as b, and will measure the maximum size of the tumor in tumor development direction 2 and define it as a. Then the system will calculate the time period for applying the electric field in tumor development direction 1 as: t1=(b / (a+b))*T, and the time period for applying the electric field in tumor development direction 2 as: t2=(a / (a+b))*T. Thus, the computer simulation analysis software completes the determination of the direction and time of electric field application. At this point, the analysis and measurement of the optimal field strength application plan are all completed, and the computer simulation analysis software has confirmed the optimal electric field application plan.

[0098] Figure 31 The figure shows the circuit block diagram of the electric field generating device 1. The internal circuit mainly consists of a power supply system, an information interaction interface, a controller, an AC voltage generator, a switch array, and an external electrode interface. The external electrode interface is the electrode interface 13 of the electric field generating device 1. Figure 32As shown, the AC voltage generator generates the AC voltage required to be applied to the user's head, which is an AC signal. Since the AC signal has no positive or negative distinction, the two lines of the AC voltage output are defined as L phase and N phase respectively for the purpose of distinction. Each external electrode interface is connected to the L phase and N phase output by the AC voltage generator through two switches, switch 1 and switch 2, respectively. This is equivalent to each external electrode interface being able to freely choose between the three states of connected to N phase, connected to L phase, and not connected through program control. Furthermore, since a single external electrode interface will be connected to the wire 2 when necessary, and then connected to the electrode buckle 4 through the wire 2, and then fixed to the mounting hole 316 of the cap body 3 through the electrode buckle 4, it is equivalent to saying that the AC signal applied to the electrode buckle 4 at the mounting hole 316 position can be freely switched between L phase, N phase, and not connected. Based on this switching function combined with the different positions of the electrode assembly, the electric field direction can finally be freely switched. Examples of generating different electric field directions can be reviewed. Figure 28 、 Figure 29 and Figure 30 The layout of the external electrode interface (i.e. electrode interface 13) is as follows: Figure 3 As shown, the electrodes 316 of the cap body 3 correspond to each other. The electrode assembly array output by the computer simulation analysis software is connected to the electric field generating device 1 and the cap body 3 through the wire 2, which completes the Figure 14 In the electric field application process flow chart, in the step of "connecting the electrodes to the electric field generating device", after completing this step, the electric field generating device 1 is turned on to perform electric field therapy.

[0099] The generation of electrode buckle positions in the above-mentioned electric field application method and the electric fields generated for various combinations of electrode buckle positions mostly rely on computer simulation. Since this method needs to simulate the electric field generated by each electrode buckle position, it has high requirements on computer hardware performance and is time-consuming. Therefore, the inventors invented another electric field application method. This method determines the final electrode buckle layout plan by actually measuring the current and voltage of the electric field generated by paired electrode buckle groups, so as to improve the accuracy and efficiency of electric field therapy, reduce hardware requirements, and reduce costs.

[0100] The above is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present application should be included in the scope of protection of the present application.

Claims

1. A head-mounted therapeutic device, characterized in that: The head-mounted therapeutic device includes an electric field generating device, a cap having a plurality of mounting holes, a plurality of electrode buckles that match the mounting holes of the cap, and a plurality of wires that connect the plurality of electrode buckles to the electric field generating device one by one. The method for using the head-mounted therapeutic device includes the following steps: Step 1. Determine multiple preliminary positional assembly schemes for multiple electrodes buckled on the cap body in three-dimensional space based on image data associated with the target area of ​​the subject and the skin surface condition; Step 2. According to the assembly scheme of the electrode buckles at each position on the cap body, determine the optimal electrode buckle shape and size combination to form an overall layout scheme of multiple groups of electrode buckles; Step 3. Perform an electric field generation simulation based on each of the electrode buckle overall layout schemes to screen out multiple sets of electrode buckle overall layout schemes that can fully cover the target area, and select the set of electrode buckle overall layout schemes with the largest field strength in the target area as the final electrode buckle overall layout scheme; Step 4. Generate an optimal electric field application plan based on the final electrode buckle overall layout plan and the size and / or expansion direction of the target area for applying the tumor treatment electric field.

2. The head-mounted therapeutic device according to claim 1, wherein: Step 1 specifically includes: first inputting the user's brain image into computer simulation analysis software for reconstruction to obtain a three-dimensional model of the user's brain. If the user has undergone surgery, the user's surgery position is simultaneously marked on the virtual head model diagram of the computer simulation analysis software; then, the position of the mounting hole corresponding to the incision position is preferentially removed from the three-dimensional model of the user's brain containing the cap body, and the required electric field application area is determined around the tumor position and the incision position, and based on the required electric field application area, multiple preliminary position assembly schemes are formed for multiple electrodes buckled on the cap body.

3. The head-mounted therapeutic device according to claim 2, wherein: Step 1 also includes: selecting a suitable position assembly scheme based on the electric field completely covering the tumor area and generating as many electric field transformation directions as possible.

4. The head-mounted therapeutic device according to claim 2, wherein: Step 2 specifically includes: configuring the shape and size of the electrode buckles at various positions based on a plurality of preliminary position assembly schemes to form a plurality of overall layout schemes of the electrode buckles.

5. The head-mounted therapeutic device according to claim 4, wherein: The electrode buckle also includes an electrode seat, and the optimal electrode buckle shape and size combination is achieved by selecting the shape and size of the electrode seat in combination with the head position of the mounting hole in the position assembly scheme and the curvature of the head position.

6. The head-mounted therapeutic device according to claim 5, wherein: The optimal electrode buckle shape and size combination includes using the electrode buckle with a polygonal electrode seat at the corner position and using the electrode buckle with a circular electrode seat at the middle position.

7. The head-mounted therapeutic device according to claim 1, wherein: The final electrode buckle overall layout plan described in step 3 is achieved by performing field strength analysis and selecting the layout plan with the largest field strength after using computer simulation analysis software to simulate the electric field generation based on each of the electrode buckle overall layout plans, giving priority to excluding layout plans that generate electric fields but cannot fully cover the target area or are not focused enough, or layout plans that generate electric fields that cover too many non-tumor areas.

8. The head-mounted therapeutic device according to claim 1, wherein: The electric field generating device has an electrode interface corresponding one-to-one to the electrode buckle, and the electrode interface is electrically connected to the electrode buckle through the corresponding wire. Step 4 specifically includes: installing the electrode buckle in the corresponding mounting hole on the cap body according to the final electrode buckle overall layout plan, and connecting the electrode buckle with the corresponding electrode interface in the electric field generating device through the wire. The electric field generating device applies a tumor treatment electric field to the target area according to the optimal electric field application plan.

9. The head-mounted therapeutic device according to claim 2, wherein: The generation of the optimal electric field application scheme in combination with the size and / or expansion direction of the target area in step 4 specifically involves allocating the duration of electric field application in the X and Y directions in each cycle according to the size ratios of the target area in the X and Y directions.

10. The head-mounted therapeutic device according to claim 2, wherein: The optimal electric field application scheme generated by combining the size and / or expansion direction of the target area in step 4 is specifically to allocate the duration ratio of the electric field application in the X direction, Y direction and B direction in each cycle according to the size ratio of the target area in the X direction, Y direction and the diffusion direction of B direction.

11. The head-mounted therapeutic device according to claim 2, wherein: The electric field generating device includes a power supply system, an AC voltage generator, a switch array and an electrode interface. The AC voltage generator has L-phase and N-phase outputs, and each electrode interface is connected to the L-phase and the N-phase respectively through the switch array.

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