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 (100). The device comprises an electric field generator (1), a cap body (3), a plurality of electrode fasteners (4), and a plurality of conductive wires (2). The method comprises the following steps: step 1, determining, on the basis of image data associated with a target area and skin surface conditions of a subject, a plurality of preliminary position assembly schemes of the plurality of electrode fasteners (4) on the cap body (3) in three-dimensional space; step 2, determining, according to the position assembly schemes of the electrode fasteners (4) on the cap body (3), the optimal combination of shapes and sizes of the electrode fasteners (4) to form a plurality of overall layout schemes of the electrode fasteners (4); step 3, performing, according to each overall layout scheme of the electrode fasteners (4), electric field generation simulations to find out a plurality of overall layout schemes of the electrode fasteners (4) that comprehensively cover the target area, and selecting the overall layout scheme of the electrode fasteners (4) with the maximum electric field strength in the target area as the final overall layout scheme of the electrode fasteners (4); and step 4, generating, on the basis of the final overall layout scheme of the electrode fasteners (4) and the size and / or expansion direction of the target area, an optimal electric field application scheme.

Description

Electric field application method for head-mounted therapeutic device 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.

[0005] Summary of the Invention

[0006] The present application provides an electric field application method for a head-mounted treatment device that can accurately treat tumor sites.

[0007] Specifically, this application is implemented through the following technical solutions:

[0008] 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.

[0009] 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.

[0010] 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.

[0011] 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.

[0012] 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.

[0013] 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.

[0014] 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.

[0015] 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.

[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 and Y directions in each cycle according to the size ratios of the target area in the X and Y directions.

[0017] 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.

[0018] 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.

[0019] 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.

[0020] 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

[0021] FIG1 is a perspective view of a head-mounted therapeutic device according to one embodiment of the present application;

[0022] FIG2 is a schematic diagram showing the distribution of mounting holes on the cap body of the head-mounted therapeutic device shown in FIG1 ;

[0023] FIG3 is a schematic diagram showing the distribution of electrode interfaces of the electric field generating device of the head-mounted therapeutic device shown in FIG1 ;

[0024] FIG4 is a schematic diagram showing the distribution of the mounting holes on the cap body shown in FIG1 on the user's head;

[0025] FIG5 is a perspective view of the electrode buckle of the head-mounted therapeutic device shown in FIG1;

[0026] FIG6 is a schematic diagram of a fixing cover of the electrode buckle shown in FIG5 ;

[0027] FIG7 is a schematic diagram of an electrode seat of the electrode buckle shown in FIG5 ;

[0028] FIG8 is a cross-sectional view of the electrode seat of the electrode buckle shown in FIG7 ;

[0029] FIG9 is a cross-sectional view of the fixing cover of the electrode buckle shown in FIG6 ;

[0030] FIG10 is a partial cross-sectional view of the head-mounted therapeutic device shown in FIG1 ;

[0031] FIG11 is a plan view of the wire shown in FIG1 ;

[0032] FIG12 is a plan view of a guide wire of a head-mounted therapeutic device according to another embodiment of the present application;

[0033] FIG13 is a schematic flow chart of an electric field application method for the head-mounted therapeutic device of the present application;

[0034] FIG14 is a flow chart of the electric field application process of the head-mounted therapeutic device of the present application;

[0035] FIG15 is a diagram of a virtual head model after scanning the user's tumor location and marking the surgical location;

[0036] FIG16A is a schematic diagram of an electrode assembly array generated in accordance with the user situation in FIG15 and in combination with the cap mounting hole positions of the head-mounted therapeutic device of the present application;

[0037] FIG16B is an electrode holder assembly information table corresponding to the electrode buckle of the cap body mounting hole position of FIG16A;

[0038] FIG17 is a schematic diagram showing the preferred removal of tumor locations, marking of surgical incision locations, and integration of the cap mounting holes of the head-mounted therapeutic device of the present application;

[0039] FIG18 is a preliminary configuration of the first electrode assembly area corresponding to the user situation in FIG15 ;

[0040] FIG19 is a preliminary configuration of the second electrode assembly area corresponding to the user situation in FIG15 ;

[0041] FIG20 is a schematic diagram of the assembly area corresponding to the first electrode assembly area solution shown in FIG18;

[0042] FIG21 is a schematic diagram of the electric field region between a pair of electrodes;

[0043] FIG22 is a schematic diagram of two electric field regions corresponding to the first and second electrode assembly area schemes;

[0044] FIG23 is a schematic diagram of applying an electric field in the Y direction corresponding to the optimal electric field set for the user situation in FIG15 ;

[0045] FIG24 is a schematic diagram of applying an electric field in the X direction corresponding to the optimal electric field set for the user situation in FIG15 ;

[0046] FIG25 is similar to FIG15 , showing a virtual head model of a user after the tumor has spread;

[0047] FIG26A is a schematic diagram of an electrode assembly array corresponding to the tumor generated after diffusion in FIG25;

[0048] FIG26B is an electrode base assembly information table corresponding to the electrode buckle of the electrode assembly array of FIG26A;

[0049] FIG27 is a schematic diagram of applying an electric field in the Y direction corresponding to the optimal electric field set for the user situation in FIG25 ;

[0050] FIG28 is a schematic diagram of applying an electric field in the X direction corresponding to the optimal electric field set for the user situation in FIG25 ;

[0051] FIG29 is a schematic diagram of applying an electric field in the direction B corresponding to the optimal electric field set for the user situation in FIG25 ;

[0052] Figure 30 is a schematic diagram of the size and development direction of a user's tumor;

[0053] FIG31 is a block diagram of the internal circuit of the electric field generating device shown in FIG1 ;

[0054] FIG32 is a block diagram of a switch array circuit of the electric field generating device shown in FIG1 .

[0055] Description of the accompanying drawings: 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, slot 417, 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 position 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] As shown in reference figure 1, 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] 3 and 4 , and in combination with FIG. 1 , 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 one to one with the mounting hole 316 on the cap body 3. For ease of understanding, the electrode interface 13 and the mounting hole 316 are marked accordingly in Figures 4 and 5. 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 is electrically connected to the electrode buckle 4 located at the corresponding mounting hole 316 on the cap body 3 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] As shown in reference figure 2, 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 the comprehensive consideration of the head structure, brain position, comfort, etc., 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] 5 to 10 , the specific structure of the electrode buckle 4 will be 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] As shown in FIG10 , 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 inserted into the second limiting groove 428 of the fixing cover 42. The limiting walls 426 and the bottom wall 423 of the fixing cover 42 tightly clamp and fix the upper flange 411 of the electrode holder 41, 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 the 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] Referring to Figures 10 and 11, 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 disc-shaped and 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, the mounting hole 316 expands outward during the process of the electrode holder 41 being inserted into the mounting hole 316 from the inside of the cap body 31 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 card groove 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] With reference to FIG12 , the present application also provides another embodiment of a head-mounted therapeutic device, which is substantially 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 electrical 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 portion.

[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] Referring to Figure 13 and in combination with Figure 14, 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 multiple groups of electrode buckle overall layout schemes; Step 3. Perform electric field generation simulation based on 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 and 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 scan is input and the incision location is annotated, the computer simulation analysis software will display an image similar to Figure 15. The outer circle in Figure 15 represents the top-down outline of the brain, with the tumor location 001 identified through the image and the incision location 002 indicated by annotation within it. The computer simulation analysis software analyzes a series of information, including tumor location, size, depth, incision location, and area, to output an 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 shows an example of an electrode assembly array output by computer simulation analysis software. The marked tumor location 001 represents the location of the user's brain tumor, and the incision location 002 represents the location of the incision after the user's surgery has healed. If the user did not undergo surgery, there is no incision location. The quadrilateral ring surrounding tumor location 001 and incision location 002 represents the assembly area 003 for all electrode buckles 4 required for assembly, as calculated by the computer simulation analysis software. The outer frame of assembly area 003 is 003A, and the inner frame of assembly area 003 is 003B. After obtaining the assembly area 003 for the electrode buckle 4, the computer simulation analysis software calculates the configuration information for the electrode buckle 4 that should be adapted for each mounting hole 316 based on the different positions of the user's head and the maximum area of ​​electric field coverage of the tumor. Specifically, it calculates the shape and size of the electrode holder 41 that should be configured. This process will be described in detail below.

[0080] First, a preliminary assembly area for the electrode buckle 4 is formed. As shown in FIG17 , when determining the configuration area 003, the tumor location 001 and the incision location 002 are first excluded. For example, in FIG16A , the mounting holes 316 at locations A'0, A'+1, B'0, and B'+1 are excluded areas where the electrode buckle 4 is not required. This arrangement is primarily due to the fact that A'0 and B'0 are located within the area of ​​tumor location 001. Typically, prior to electric field therapy, the patient's tumor is surgically removed. After the tumor is removed, the resected area is often filled with cerebrospinal fluid, resulting in a depression at locations A'0 and B'0 on the patient's head. Therefore, it is difficult to ensure close contact between the electrode buckle 4 and the patient's skin when installing it at tumor location 001. Therefore, the assembly 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 to perform 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 by the electric field and the changeability of the direction. As shown in Figures 18 and 19, the examples of electric field lines are examples of 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, that is, complete the multiple preliminary position assembly plans for the electrode buckle 4 in step 1.

[0083] Next, the electrode buckle 4 configuration plan was determined. After completing the above steps, computer simulation analysis software obtained a preliminary positioning and assembly plan for multiple electrode buckles 4, as shown in Figures 18 and 19. For each electrode buckle 4 positioning and assembly plan, in addition to knowing the required mounting holes 316 to be covered, it was also necessary to determine the type of electrode holder 41 of the electrode buckle 4 that each mounting hole 316 required to be installed. Taking the mounting holes in FIG. 17 as an example, as shown in FIG. 20 , 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. The maximum size area of ​​the electrode holder 41 that can be assembled in the C'+2 mounting hole 316 in FIG. 20 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 area matching it from 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 in the calculation. This ensures that the preferred electrode buckle 4 covers as much of this area 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, as shown in FIG. 16A and FIG. 16B , 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 performed. The computer simulation analysis software performs further focus and coverage analysis and screening based on the previously calculated overall layout schemes of multiple groups of electrode buckles 4. The screening principles are focus and coverage, mainly to ensure that the selected overall layout scheme, after the electrode buckles 4 are installed, the electric field generated in all directions when the electric field is applied can fully focus and cover the tumor. As shown in Figure 21, two electrode buckles 4 have been installed in two mounting holes 316. A regional electric field can be generated between the two electrode buckles 4. The electric field lines E of this regional electric field must be able to fully cover the tumor 008; and due to the size limitations of the electrode base 41 of the electrode buckle 4, it also has a focusing function, which can ensure that the electric field covers as few areas as possible without tumors. Based on these two principles, the computer simulation analysis software will choose to prioritize and exclude the following overall layout schemes: 1. Layout schemes where the generated electric field cannot fully cover the tumor or is not focused enough, and 2. Overall layout schemes where the generated electric field covers too many non-tumor areas.

[0086] Next, a field strength optimization analysis is performed. After eliminating all possible solutions based on the above analysis, the final electrode buckle layout is determined. This involves performing a final field strength analysis on multiple electrode buckle layouts that meet the requirements of the above steps. Under the same applied voltage, the final layout is analyzed to determine which layout produces the highest field strength at the tumor location. For example, the field strengths generated at various locations by the two solutions shown in Figures 18 and 19 are compared, and the one with the highest field strength under the same applied voltage is selected as the optimal one. Referring to FIG. 22 , 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. First, it can be seen from FIG. 22 that the electric fields generated by these two areas can both cover the tumor 008, but From the analysis of the electrode distance, it is obvious that the distance from the mounting hole 316 marked as A'+2 to the mounting hole marked as A'-1 is smaller than the distance from the mounting hole 316 marked as A'+2 to the mounting hole 316 marked as A'-2. According to the basic physical field strength formula E=U / d, it can be seen that 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, the electrode assembly scheme in Figure 18 is obviously better than the electrode assembly scheme in Figure 19. Therefore, the system determines that the electrode assembly scheme in Figure 18 is the final overall layout scheme of the electrode buckle, and outputs the electrode assembly array.

[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 an analysis of the optimal electric field application scheme, that is, the optimal electric field application scheme finally calculated by the computer simulation analysis software according to Figure 15. Specifically, assuming that the time period for applying the electric field to the user is T, then within the period T, the electric field application is divided into two directions, namely the Y direction (see Figure 23) and the X direction (see Figure 24), wherein the electric field application period in the Y direction is 0.6T, and its implementation method is to connect the electrode buckles 4 at the mounting holes 316 positions marked as C'-1, C'0, C'+1, and C'+2 at time 0 to the L phase of the electric field generating device 1, and connect the electrode buckles 4 at the mounting holes 316 positions marked as G'-1, G'0, G'+1, and G'+2 to the N phase of the electric field generating device 1, and the electrode buckles 4 at the mounting holes 316 positions marked as G'-1, G'0, G'+1, and G'+2 are connected ... There is no electrical connection between the electrode buckle 4 at the hole 316 position and the electric field generating device 1. After the connection is completed, the electric field generating device 1 begins to apply AC voltage for a time of 0.6T. Then, at the time of 0.6T, all the electrode buckles 4 at the mounting holes 316 positions that have been connected are disconnected. Then, the electrode buckles 4 at the mounting holes 316 positions 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 positions marked as C'+2, B'+2, A'+2, and G'+2 are connected to the N phase of the electric field generating device 1, that is, the direction is switched to the X direction. Then, AC voltage is applied in this direction for a time of 0.4T, thus completing the electric field application within the entire T period. After that, the electric field is applied repeatedly in a control mode with a period of time of T. Given that the tumor's location is primarily concentrated in the Y direction and its volume is large in the Y direction, the computer simulation analysis software determined the optimal application plan based on information analysis such as the most likely direction of tumor spread. This is to apply an electric field with a period of 0.6T in the Y direction and a period of 0.4T in the X direction.

[0089] Table 1: Optimal electric field application scheme

[0090] If the user discovers that their tumor has spread from its original location during the next medical imaging examination, assuming that the computer simulation analysis software scans and annotates the virtual head model as shown in FIG. 25 , it can be clearly observed from tumor location 001′ in FIG. 25 that the tumor area has increased compared to tumor location 001 in FIG. 15 , and the computer simulation analysis software analyzes the possible spread direction as shown in FIG. 25 as tumor spread direction A (consistent with the X-axis direction) or tumor spread direction B (approximately 45° counterclockwise with the X-axis). The computer simulation analysis software then generates a new electrode assembly array and an optimal electric field application plan. The new electrode assembly array and electrode holder assembly information table are shown in FIG. 26A and FIG. 26B . Since the tumor has only slightly spread toward the mounting hole 316 location labeled B′+1, the optimal electrode assembly array in FIG. 26A is essentially the same as that in FIG. 16A , except that the corresponding optimal electric field application plan is different.

[0091] Table 2 is the optimal electric field application scheme of another embodiment. Specifically, assuming that the time period for applying the electric field to the user is T, then within the period T, the electric field application is divided into three directions, namely, the Y direction (see Figure 27), the X direction (see Figure 28), and the B direction (see Figure 29), where the electric field application period in the Y direction is 0.3T. The implementation method is that at time 0, the electrode buckles 4 at the mounting holes 316 positions marked as C'-1, C'0, C'+1, and C'+2 are connected to the L phase of the electric field generating device 1, and the electrode buckles 4 at the mounting holes 316 positions marked as G'-1, G'0, G'+1, and G'+2 are connected to the N phase of the electric field generating device 1. The electrode buckles 4 at the other irrelevant mounting holes 316 positions are not connected. 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 electric field application 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.

[0092] Table 2: Information and instructions for the optimal electric field application plan after tumor location spread

[0093] 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.

[0094] Among them, the computer simulation analysis software mainly analyzes the development direction of the tumor and the size of the tumor that has developed in each development direction to determine the direction of electric field application and the time period of electric field application in each electric field direction. Specifically, referring to Figure 30, with respect to the tumor position 001', there are two main development directions, namely tumor development direction 1 and tumor development direction 2. The computer simulation analysis software will prioritize determining that there are two directions of electric field application, namely tumor development direction 1 (i.e., the horizontal direction in the figure) and tumor development direction 2 (i.e., the vertical direction in the figure), and will confirm whether each mounting hole 316 is L phase or N phase based on the aforementioned determined electrode assembly array to ensure that the system can smoothly output the electric field in these two 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.

[0095] Figure 31 shows a block diagram of the internal circuitry of the electric field generating device 1. The internal circuitry primarily consists of a power supply system, an information exchange 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. Referring to Figure 32, the AC voltage generator generates the AC voltage required for application to the user's head. This is an AC signal. Since AC signals have no positive or negative polarity, the two AC voltage output lines are defined as L-phase and N-phase, respectively, for ease of distinction. Each external electrode interface is connected to the L-phase and N-phase outputs of the AC voltage generator via two switches, Switch 1 and Switch 2, respectively. This allows each external electrode interface to freely select between three states: connected to the N-phase, connected to the L-phase, or disconnected, through program control. Furthermore, since a single external electrode interface will be connected to a 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 no connection. Based on this switching function combined with the different positions of the electrode assembly, it is ultimately possible to achieve free switching of the electric field direction. Examples of generating different electric field directions can be seen in Figures 28, 29 and 30. The arrangement of the external electrode interface (i.e., the electrode interface 13) is shown in Figure 3, which corresponds one to one to each mounting hole 316 of the cap body 3. According to the electrode assembly array output by the computer simulation analysis software, the electric field generating device 1 is connected to the cap body 3 through the wire 2, which completes the "connecting electrodes to the electric field generating device" step in the electric field application process step block diagram in Figure 14. After completing this step, the electric field generating device 1 is turned on to perform electric field therapy.

[0096] 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.

[0097] 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 method for applying an electric field of a head-mounted therapeutic device, characterized in that: The head-mounted treatment device comprises an electric field generating device, a cap body having a plurality of mounting holes, a plurality of electrode buckles matched 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, and the electric field applying method comprises the following steps: Step 1. Determine multiple preliminary position 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 combination of electrode buckle shapes and sizes to form an overall layout scheme of multiple groups of electrode buckles; Step 3. Performing an 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 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. 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 electric field application method according to claim 1, characterized in that: The step 1 specifically includes: first inputting the user's brain image into the computer simulation analysis software for reconstruction to obtain a three-dimensional model of the user's brain; if the user has undergone surgery, then marking the user's surgery position on the virtual head model diagram of the computer simulation analysis software; then preferentially removing the position of the mounting hole corresponding to the incision position from the three-dimensional model of the user's brain containing the cap body, and determining the required electric field application area around the tumor position and the incision position, and forming multiple preliminary position assembly schemes for buckling multiple electrodes on the cap body based on the required electric field application area.

3. The electric field application method according to claim 2, characterized in that: The 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 electric field application method according to claim 2, characterized in that: The step 2 specifically includes: configuring the shape and size of the electrode buckle at each position based on a plurality of the preliminary position assembly schemes to form a plurality of overall layout schemes of the electrode buckle.

5. The electric field application method according to claim 4, characterized in that: 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 electric field application method according to claim 5, characterized in that: 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.

7. The electric field application method according to claim 1, characterized in that: The final electrode buckle overall layout plan described in step 3 is achieved by using computer simulation analysis software to perform field strength analysis and select the layout plan with the largest field strength after performing multiple schemes of 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.

8. The electric field application method according to claim 1, characterized in that: 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. The 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 electric field application method according to claim 2, characterized in that: 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 and the Y direction in each cycle according to the size ratio of the target area in the X direction and the Y direction.

10. The electric field application method according to claim 2, characterized in that: 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 proportion of the electric field application in the X direction, Y direction and B direction in each cycle according to the size proportion of the target area in the X direction, Y direction and the diffusion direction of B.

11. The electric field application method according to claim 2, characterized in that: 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.

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