Head-mounted treatment device

Abstract

This application provides a head-mounted therapeutic device, including an electric field generating device, a cap, several sets of electrode buckles disposed on the cap, and several wires electrically connecting the electrode buckles to the electric field generating device. The electric field generating device contains a final overall layout scheme for the electrode buckles, and the electrode buckles are assembled onto the cap according to the final electrode buckle layout scheme to accurately apply an electric field to the target area.

Description

[0001] This application is a divisional application of the applicant's patent application filed on October 31, 2023, with application number 202311438020.2 and invention title "Method for Applying Electric Field to Head-Mounted Treatment Device". Technical Field

[0002] This application relates to the field of medical technology, and in particular to a head-mounted treatment device. Background Technology

[0003] Currently, the main treatments for tumors include surgery, radiotherapy, and chemotherapy, but all have their drawbacks. For example, radiotherapy and chemotherapy can cause side effects and kill normal cells. Using electric fields to treat tumors is also at the forefront of research. Tumor electric field therapy uses a special electric field generator to produce a low-intensity, medium-to-high-frequency, alternating electric field that interferes with the mitotic process of tumor cells. Studies have shown that electric field therapy is effective in treating glioblastoma, non-small cell lung cancer, and malignant pleural mesothelioma. The applied electric field can affect the aggregation of microtubules, prevent spindle formation, inhibit mitosis, and induce apoptosis in cancer cells.

[0004] Chinese Invention Patent Publication No. 114099958A discloses a tumor electric field therapy device for treating tumors, including an electric field generating device and several electrode patches applied to the user's body surface. The electric field generating device generates alternating electrical signals and transmits these signals to the electrode patches, generating a therapeutic electric field between the electrode patches that is applied to the user's tumor. The electrode patches have multiple electrode units; most current electrode patches have 9, 13, or 20 electrode units, with a fixed structure and size that may not be suitable for all individuals. Furthermore, when the electrode patches are applied to the user's head, the resulting alternating electric field covers a wide area, potentially placing large non-tumor areas in unnecessary electric fields and affecting normal cells. Existing electrode patches need to be replaced every 2-3 days, and the replaced patches are discarded and cannot be reused. When applied to non-planar areas, such as the user's head, existing electrode patches may peel up or not adhere tightly, preventing the alternating electric field generated by the paired electrode patches from being applied to the target location, thus affecting the therapeutic effect on the tumor. In addition, because the existing electrode patches cover a large area, an electric field is applied to non-tumor areas as well.

[0005] Therefore, an improved head-mounted treatment device is needed. Summary of the Invention

[0006] This application provides a head-mounted treatment device capable of precisely applying an alternating electric field to a tumor site.

[0007] Specifically, this application is achieved through the following technical solution: a head-mounted treatment device suitable for applying an alternating electric field to a tumor region of the head, comprising: an electric field generating device, including an AC voltage generator for generating alternating current signals, a controller, a switch array, and a plurality of electrode interfaces, wherein the controller selectively transmits the alternating current signals to at least two of the plurality of electrode interfaces by configuring the state of the switch array; a cap having a plurality of mounting holes corresponding one-to-one with the plurality of electrode interfaces; and a plurality of electrode buckles detachably assembled to each of the mounting holes of the cap, wherein each of the electrode buckles is attached to the cap. The assembly layout scheme on the body is determined by the final overall layout scheme of the electrode buckles calculated based on the location and size of the user's brain tumor and stored in the electric field generating device. The assembly layout scheme of the electrode buckles includes the assembly position of each electrode buckle, the size of each electrode buckle, and the shape of each electrode buckle; and a number of wires configured to: electrically connect the corresponding electrode buckles to the corresponding electrode interfaces according to the determined assembly position of each electrode buckle, and transmit the alternating electrical signal transmitted to each electrode interface to the corresponding electrode buckle when the switch array electrically connected to each electrode interface is turned on.

[0008] Preferably, the final overall layout scheme of the electrode buckles is determined by actually measuring the current and voltage of the electric field generated by the paired electrode buckles; or the final overall layout scheme of the electrode buckles is determined by obtaining the optimal electric field application scheme by computer simulation analysis software based on the three-dimensional model reconstructed from the image data related to the user's target area and the skin surface condition, and by performing electric field generation simulation on the reconstructed three-dimensional model.

[0009] Preferably, the final overall layout scheme of the electrode buckle is determined based on whether each electric field in the electric field generation simulation fully covers the target area, whether it covers a lot of non-target areas, and whether the field strength generated in the simulation is the maximum.

[0010] Preferably, the optimal electric field application scheme is further determined based on the size of the target region and / or the expansion direction of the target region, wherein the expansion direction of the target region is determined based on medical image data of the user's target region at different stages.

[0011] Preferably, the optimal electric field application scheme includes each electric field application direction, the time for applying the electric field in each electric field direction, and the electric field switching period in each direction.

[0012] Preferably, the AC voltage generator has an L-phase output and an N-phase output, and the electrode interface has three connection states with the AC voltage generator: connected to the L-phase output, connected to the N-phase output, and not connected.

[0013] Preferably, the controller controls each electrode interface to freely switch between being connected to the L-phase output of the AC voltage generator, being connected to the N-phase output of the AC voltage generator, and not being connected to the AC voltage generator via the switch array.

[0014] Preferably, the cap has an arc-shaped covering area that covers the user's head from the root of the nose to the occipital protuberance, and the mounting holes are distributed in 80% of the upper side of the arc-shaped covering area.

[0015] Preferably, the cap body is also provided with several perforated holes for heat dissipation.

[0016] Preferably, the electrode buckle includes a fixed cover that fits together with an electrode base. The electrode base extends from the side of the cap body facing the user's head through the mounting hole and is detachably assembled onto the cap body by snapping its corresponding part against the edge of the cap body located around the mounting hole.

[0017] Preferably, the fixing cap is detachably fixed to the top of the electrode holder from the side of the cap body away from the user's head.

[0018] Preferably, the wire is plugged into the corresponding electrode interface through a plug at one end, and inserted into the opening of the fixing cover through a conductive piece at the other end, and contacts the top of the electrode holder.

[0019] Preferably, the conductive sheet has a contact portion, the top of the electrode holder has a recess corresponding to the contact portion, and the fixing cover has a pressing portion corresponding to the contact portion, the pressing portion pressing the contact portion against the recess.

[0020] The head-mounted treatment device of this application can accurately apply an electric field to the tumor site and reduce the electric field applied to non-tumor sites, and can freely switch the direction of the electric field.

[0021] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description

[0022] Figure 1 A perspective view of a head-mounted therapeutic device according to one embodiment of this application;

[0023] Figure 2 for Figure 1 A schematic diagram showing the distribution of mounting holes on the cap of the head-mounted treatment device;

[0024] Figure 3 for Figure 1 A schematic diagram showing the distribution of electrode interfaces of the electric field generator in the head-mounted therapeutic device.

[0025] Figure 4 for Figure 1 The diagram shows the distribution of the mounting holes on the cap body on the user's head.

[0026] Figure 5 for Figure 1 A three-dimensional diagram showing the electrode clips of the head-mounted treatment device;

[0027] Figure 6 for Figure 5 A schematic diagram of the fixing cover for the electrode buckle shown;

[0028] Figure 7 for Figure 5 A schematic diagram of the electrode holder for the electrode buckle shown;

[0029] Figure 8 for Figure 7 A cross-sectional view of the electrode holder of the electrode buckle shown;

[0030] Figure 9 for Figure 6 A cross-sectional view of the fixing cover of the electrode buckle shown;

[0031] Figure 10 for Figure 1 A partial cross-sectional view of the head-mounted treatment device shown;

[0032] Figure 11 for Figure 1 A plan view of the conductor shown;

[0033] Figure 12 This is a plan view of the wires of a head-mounted therapeutic device according to another embodiment of this application;

[0034] Figure 13 This is a schematic diagram of the electric field application method for the head-mounted therapeutic device of this application;

[0035] Figure 14 A flowchart illustrating the application of an electric field to the head-mounted therapeutic device of this application;

[0036] Figure 15 A virtual head model image after scanning the user's tumor location and marking the surgical site;

[0037] Figure 16A For the corresponding Figure 15 The schematic diagram of the electrode assembly array generated by the mounting holes of the head-mounted therapeutic device in this application is based on the user situation in the application.

[0038] Figure 16B For the corresponding Figure 16A Electrode holder assembly information sheet for electrode buckles at the cap mounting holes;

[0039] Figure 17 A schematic diagram showing the mounting holes of the cap of the head-mounted treatment device in this application, in order to prioritize the removal of tumor locations and mark surgical sites;

[0040] Figure 18 For the corresponding Figure 15 The initial design of the first electrode assembly area based on the user situation;

[0041] Figure 19 For the corresponding Figure 15 The initial design of the second electrode assembly area based on the user situation is as follows;

[0042] Figure 20 for Figure 18 A schematic diagram of the assembly area corresponding to the first electrode assembly area scheme shown;

[0043] Figure 21 This is a schematic diagram of the electric field region between a pair of electrodes;

[0044] Figure 22 This is a schematic diagram of the two electric field regions corresponding to the first and second electrode assembly area schemes;

[0045] Figure 23 For the corresponding Figure 15 A schematic diagram of the application of the optimal electric field in the Y direction for the user's situation.

[0046] Figure 24 For the corresponding Figure 15 A schematic diagram of the application of the electric field in the X direction to the optimal electric field set for the user situation;

[0047] Figure 25 and Figure 15 Similarly, the illustration shows a virtual head model of a user after their tumor has spread;

[0048] Figure 26A For the corresponding Figure 25 Schematic diagram of electrode assembly array for tumor formation after metastasis;

[0049] Figure 26B For the corresponding Figure 26A Electrode assembly information sheet for electrode holders of electrode assembly array;

[0050] Figure 27 For the corresponding Figure 25 A schematic diagram of the application of the optimal electric field in the Y direction for the user's situation.

[0051] Figure 28 For the corresponding Figure 25 A schematic diagram of the application of the electric field in the X direction to the optimal electric field set for the user situation;

[0052] Figure 29 For the corresponding Figure 25A schematic diagram of the application of the electric field in the B direction of the optimal electric field set for the user situation;

[0053] Figure 30 A schematic diagram showing the size and growth direction of the user's tumor;

[0054] Figure 31 for Figure 1 The diagram shows the internal circuit block diagram of the electric field generator.

[0055] Figure 32 for Figure 1 The diagram shows the circuit block diagram of the switch array of the electric field generating device.

[0056] Explanation of reference numerals in the attached figures:

[0057] Head-mounted therapeutic device 100, electric field generator 1, power interface 11, interactive interface 12, electrode interface 13, outer shell 14, wire 2, plug 21, conductive sheet 22, contact part 221, coil 22', cap body 3, cap main body 31, side part 311, clearance hole 312, hollow hole 313, warp band 314, weft band 315, mounting hole 316, adjustment band 32, electrode buckle 4, electrode seat 41, upper flange 411, middle flange 412, lower flange 413, connecting post 414, top 415, groove 416, slot 4 17. Recess 418. Fixing cover 42. Top wall 421. Side wall 422. Bottom wall 423. Through hole 4231. Rib 4232. Receiving cavity 424. Opening 425. Limiting wall 426. Through hole 4261. First limiting groove 427. Second limiting groove 428. Pressing part 429. Tumor position 001, 001'. Blade position 002. Assembly area 003. Outer frame line 003A. Inner frame line 003B. Assembly coverable area 004. Outer edge line 005. Inner edge line 006. Dividing line 007. Tumor 008. Detailed Implementation

[0058] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numbers in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this application. Rather, they are merely examples of apparatuses, systems, devices, and methods consistent with some aspects of this application.

[0059] refer to Figure 1As shown, the head-mounted treatment device 100 of this application includes an electric field generating device 1, several wires 2, a cap 3, and several electrode clips 4 dispersed on the cap 3. The electric field generating device 1 generates alternating electrical signals. The top side of the outer shell 14 of the electric field generating device 1 is provided with a power interface 11 and an interaction interface 12, and the side of the outer shell 14 is provided with several electrode interfaces 13. One end of the wires 2 is provided with a plug 21 that connects to the electrode interface 13, and the other end is provided with a conductive piece 22 that contacts and conducts electricity with the electrode clips 4 on the cap 3. The cap 3 is worn on the user's head, and the several wires 2 transmit the alternating electrical signals generated by the electric field generating device 1 to the electrode clips 4, so that an alternating electric field is generated between the several electrode clips 4, and electric field therapy is performed on the tumor on the user's head.

[0060] The hat body 3 includes a hat body 31 that covers the user's head and adjustable straps 32 connected to both sides of the bottom of the hat body 31. The adjustable straps 32 are adjustable in length to ensure a close fit between the hat body 31 and the user's head, thus adapting to different users. Preferably, the adjustable straps 32 are made of comfortable fabric. Each side of the hat body 31 has a side portion 311 extending downwards from its bottom edge. The side portion 311 has a clearance hole 312 to avoid the user's ears. The two ends of the adjustable straps 32 are connected to the bottom of the side portions 311 respectively. Alternatively, the side portions 311 can also be provided by the adjustable straps 32, which are directly connected to the bottom edge of the hat body 31.

[0061] The cap body 31 has several perforated holes 313 to improve its heat dissipation performance. The cap body 31 forms several crisscrossing warp bands 314 and weft bands 315, separated by the perforated holes 313. The cap body 31 has several mounting holes 316 for fixing the electrode buckle 4. These mounting holes 316 can be distributed on each weft band 315, on each warp band 314, or on both. In this application, the mounting holes 316 are distributed on both the weft bands 315 and the warp bands 314, and are located at the junctions of the weft bands 315 and the warp bands 314. The cap body 31 is made of an elastic material, such as silicone or elastic cloth. In this application, silicone is preferred to make the cap body 31 elastic, so that the electrode buckle 4 can make good and tight contact 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 alternating electrical signals and facilitate cleaning.

[0062] refer to Figure 3 and Figure 4 As shown, and in combination Figure 1 As shown, each electrode buckle 4 is independently connected to the corresponding electrode interface 13 of the electric field generator 1 using a single wire 2. All electrode buckles 4 are independently controlled in parallel. The electrode interface 13 on the electric field generator 1 corresponds one-to-one with 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 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 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 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 A'-5 on the cap body 3. This ensures 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. By controlling the current on and off of the relevant electrode interface 13, the application of alternating electrical signals to the electrode buckle 4 at the corresponding mounting hole 316 on the cap body 3 is controlled.

[0063] refer to Figure 2 As shown, the area that the cap body 3 can cover is an arc-shaped area from the "root of the nose" to the "occipital protuberance" of the user's head. Considering the head structure, brain position, comfort, etc., about 80% of the upper part of this arc-shaped area is defined as the area that can be covered by the mounting holes 316. This area is divided into 10 sub-areas, and each sub-area has mounting holes 316 closely arranged. Each mounting hole 316 is set at a different position on the head.

[0064] By determining the area where the alternating electric field is applied and selecting the electrode interface 13 that needs to be activated, the alternating electric signal generated by the electric field generator 1 is selectively transmitted to the electrode clips 4 at different positions on the cap 3. For example, if the user's tumor is located in the back of the head, only the relevant electrode clips 4 capable of applying an alternating electric field to the back of the head need to be installed. Based on the correspondence between the electrode interface 13 and the position of the electrode clip 4, the relevant electrode interface 13 is activated, while the relevant electrode interfaces 13 corresponding to the relevant electrode clips 4 covering other areas of the cap 3, such as the forehead, are deactivated. Compared to a whole-piece electrode patch, this application allows for flexible selection of the relevant electrode clips 4 that need to be activated, enabling more targeted treatment.

[0065] The operation steps of the head-mounted treatment device 100 for electric field therapy are as follows: 1. Generate an electrode assembly array. The computer acquires 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 electrode clips 4. According to the electrode assembly array output by the computer, multiple electrode clips 4 are installed on the mounting holes 316 of the cap body 3; 3. Set the wires 5. Insert the conductive piece 22 of the wire 2 into the electrode clip 4, and insert the plug 21 of the wire 2 into the corresponding electrode interface 13 of the electric field generator 1; 4. Put the cap body 3 with the electrode clips 4 installed and the wires 2 connected on the user's head, thus completing the connection environment setup of the entire system. The user can then turn on the head-mounted treatment device 100 to start tumor electric field therapy.

[0066] refer to Figures 5 to 10 As shown, the specific structure of electrode buckle 4 will be described below.

[0067] In this embodiment, the electrode clip 4 is generally cylindrical and includes a fixing cover 42 and an electrode base 41 that interlock. The electrode base 41 is made of dielectric material and serves as a dielectric element for blocking DC and passing AC. The electrode base 41 is made of integrally molded ceramic material, and the fixing cover 42 is made of elastic and insulating material. The fixing cover 42 is fixed on the electrode base 41 and cooperates with the electrode base 41 to fix the conductive sheet 22. The electrode base 41 has an upper flange 411, a middle flange 412, a lower flange 413, and a connecting post 414 connecting the three. The upper flange 411, the middle flange 412, and the lower flange 413 are all disc-shaped and arranged concentrically from top to bottom. The connecting post 414 is generally cylindrical, and the upper flange 411, the middle flange 412, and the lower flange 413 are arranged around the connecting post 414. The portion of the connecting post 414 that protrudes from the upper flange 411 forms a top 415. A groove 416 is formed between the upper flange 411 and the middle flange 412, surrounding the connecting post 414. A slot 417 is formed between the middle flange 412 and the lower flange 413, surrounding the connecting post 414. The conductive sheet 22 made of metal is inserted into the electrode holder 4 and does not contact the user's head. The electrode holder 41 made of ceramic material is in direct contact with the user's scalp. Therefore, there are no issues with metal toxicity or biocompatibility, and there is no need to install conductive gel.

[0068] The bottom surface of the lower flange 413 of the electrode holder 41 is in direct contact with the user's scalp. Considering the different curvatures of different parts of 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. Different parts of the user's head can be adapted to electrode holders 41 with lower flanges 413 of different shapes. In addition, electrode holders 41 with the same lower flange 413 shape can also be provided in various different sizes to meet the needs of users with different head shapes. For example, multiple electrode holders 41 can all have circular lower flanges 413, and can be provided with large, medium, and small diameter sizes for users to choose from. The design of different shapes and / or different sizes of the lower flange 413 of the electrode holder 41 can provide users with a wider range of choices to adapt to different parts of the user's head, thereby ensuring that the user's head can be in close contact with the lower flange 413 of the electrode holder 41 to ensure the stable application of alternating electrical signals.

[0069] The fixing cover 42 has a top wall 421, a side wall 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 wall 422, and bottom wall 423 together form a receiving cavity 424. The side wall 422 has a through opening 425 near the top wall 421. The fixing cover 42 also has a limiting wall 426 located inside the receiving cavity 424. The limiting wall 426 is an annular wall whose peripheral edge connects to the side wall 422. The top surface of the limiting wall 426 is flush with the bottom surface of the opening 425. A first limiting groove 427 communicating with the opening 425 is formed between the limiting wall 426 and the top wall 421, and a second limiting groove 428 is formed between the limiting wall 426 and the bottom wall 423. A through hole 4231 is provided at the center of the bottom wall 423. The diameter of the through hole 4231 is smaller than the diameter of the upper flange 411, and the diameter of the through hole 4231 is close to the diameter of the connecting post 414 of the electrode seat 41. A through hole 4261 is provided at the center of the limiting wall 426. The diameter of the through hole 4261 is smaller than the diameter of the upper flange 411, and the diameter of the through hole 4261 is close to the diameter of the connecting post 414.

[0070] Combination 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 down. Since the fixing cover 42 is made of elastic material, the through hole 4231 expands outward to allow the upper flange 411 of the electrode holder 41 to be engaged in the second limiting groove 428 of the fixing cover 42. The limiting wall 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 onto the electrode holder 41. The bottom wall 423 also has a rib 4232 located on its upper surface and surrounding the through hole 4231 to abut against the upper flange 411, which increases the clamping force of the limiting wall 426 and the bottom wall 423 on the upper flange 411. After assembly, the top 415 of the electrode holder 41 extends upward into the through hole 4261 of the fixing cover 42, and the top surface of the top 415 is coplanar with the top surface of the limiting wall 426. The bottom wall 423 of the fixing cover 42 is located in the groove 416 of the electrode holder 41, and the height of the groove 416 is greater than the thickness of the bottom wall 423 to avoid interference between the groove 416 and the bottom wall 423, which would affect the assembly of the electrode holder 41 and the fixing cover 42.

[0071] refer to Figure 10 and Figure 11 As shown, the conductive sheet 22 is electrically connected to the wire core (not shown) inside the wire 2 and is reliably fixed to one end of the wire 2. The conductive sheet 22 is approximately circular and fully exposed outside the wire 2. The opening 425 is larger than the diameter of the conductive sheet 22, allowing the conductive sheet 22 to be inserted into the first limiting groove 427 inside the fixing cover 42 through the opening 425. The limiting wall 426 of the fixing cover 42 and the top 415 of the electrode seat 41 support and guide the conductive sheet 22 for smooth insertion. When the front end of the conductive sheet 22 abuts against the side wall 422 of the fixing cover 42 located around the receiving cavity 424, it indicates that the conductive sheet 22 has been assembled in place. The conductive sheet 22 is connected to the electrode buckle 4 by a plug-in connection, making it easier to remove the wire 2 when the electrode buckle 4 needs to be replaced.

[0072] Since the contact between the conductive sheet 22 and the electrode base 41 generates contact resistance, the higher the fit and the smaller the gap between the conductive sheet 22 and the electrode base 41, the lower the contact resistance. In this embodiment, the center of the conductive sheet 22 is punched downward to form a downwardly protruding arc-shaped contact portion 221. The center of the top 415 of the electrode base 41 has a downwardly recessed arc-shaped recess 418 corresponding to the contact portion 221. The center of the top wall 421 of the fixing cover 42 has 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 recess 418, ensuring that the conductive sheet 22 and the electrode base 41 are tightly fitted, reducing contact resistance, and ensuring the application effect of the alternating electrical signal. In other embodiments, the center of the conductive sheet 22 can also be of other shapes; the key is to ensure tight contact to reduce contact resistance.

[0073] When assembling the electrode buckle 4, the electrode seat 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 post 414 of the electrode seat 41, and smaller than the diameter of the upper flange 411, the middle flange 412, and the lower flange 413. Since the cap body 31 is made of elastic material, as the electrode seat 41 is inserted into the mounting hole 316 from the inside of the cap body 31, the mounting hole 316 expands outward, causing the upper flange 411 and the middle flange 412 of the electrode seat 41 to pass through the mounting hole 316 in sequence. The edge of the warp belt 314 or weft belt 315 on the periphery of the mounting hole 316 of the cap body 3 is inserted into the slot 417 located between the middle flange 412 and the lower flange 413. The lower flange 413 remains on the inside of the cap body 31, thus reliably fixing the electrode seat 41 to the cap body 31. The height of the slot 417 is close to the thickness of the cap body 31 to prevent the electrode holder 41 from wobbling on the cap body 31. The diameter of the lower flange 413 is much larger than the diameter of the mounting hole 316, thus preventing the lower flange 413 from detaching from the mounting hole 316. After fixing the electrode holder 41, the fixing cover 42 is fixed to the electrode holder 41 by pressing. The conductive sheet 22 can be inserted into the electrode clip 4 after the fixing cover 42 is fixed to the electrode holder 41, or it can be inserted into the fixing cover 42 first and then fixed to the electrode holder 41 together with the fixing cover 42. When removing the electrode clip 4 from the cap body 31, first pull the fixing cover 42 upward to detach the fixing cover 42 from the electrode clip 4, and then pull the electrode holder 41 downward.

[0074] The cap body 3 and electrode clips 4 of the head-mounted treatment device 100 are washable. Since the electrode clips 4 are fixed to the cap body 3 by a snap-fit ​​assembly, they can be removed from the cap body 3 for separate cleaning. High-temperature steam sterilization is preferred for cleaning the electrode clips 4, allowing them to be reused and reducing usage costs. The cap body 31, made of silicone material, can be directly washed with water. Both of these operations can be performed by the user at home.

[0075] refer to Figure 12This application also provides another embodiment of the head-mounted treatment device, which is basically the same as the head-mounted treatment device 100 of the previous embodiment, except that the material of the electrode seat 41 of the electrode buckle 4 is replaced with a magnetic material, which has the function of focusing magnetism and enhancing magnetic field. The following materials are preferred: iron-silicon-aluminum, manganese-zinc, nickel-zinc, permalloy, etc. Correspondingly, the conductive piece 22 at one end of the wire 2 is replaced with a coil 22'. The wire 2 has two wire cores (not shown), which 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 the direction perpendicular to the plane where the electrode buckle 4 is located, ultimately realizing the treatment of tumors by the alternating electric field. In this application, the coil 22' and the conductive piece 22 can be collectively referred to as the conductive part.

[0076] The head-mounted therapeutic device 100 of this application includes a cap body 3 and several electrode clips 4 distributed on the cap body 3. The conductive sheet 22 or coil 22' that energizes the electrode clips 4 is connected to the electrode clips 4 by a plug-in method, which facilitates the removal of the wire 2 when replacing or cleaning the electrode clips 4. The electrode clips 4 are fixed to the cap body 3 by a snap-fit ​​assembly method, which can be easily disassembled, replaced and cleaned. It can flexibly set the position of each electrode clip 4 to meet the needs of different users and can be reused repeatedly, reducing the cost of use.

[0077] refer to Figure 13 and combined Figure 14 As shown, in order to achieve precise application of the electric field, free switching of direction, and elimination of unnecessary electrode clips 4, this 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 clips 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. Determine the optimal combination of electrode clip shape and size to form multiple sets of overall electrode clip layout schemes according to the respective position assembly schemes of the electrode clips on the cap body; Step 3. Perform electric field generation simulation according to each of the overall electrode clip layout schemes to screen out multiple sets of overall electrode clip layout schemes that can fully cover the target area, and select the set of overall electrode clip layout schemes with the largest field strength in the target area as the final overall electrode clip layout scheme; Step 4. Generate an optimal electric field application scheme based on the final overall electrode clip layout scheme, combined with the size and / or expansion direction of the target area, for applying a tumor treatment electric field.

[0078] Steps 1 to 3 above specifically involve first inputting the user's brain images, including but not limited to CT or MRI images, into the computer simulation analysis software via scanning. Simultaneously, the user's surgical site can be marked on the virtual head model in the computer simulation analysis software. If the user has not undergone surgery, this marking is unnecessary. The computer simulation analysis software combines information such as tumor location, size, depth, incision location, and area from the user's images to analyze the most suitable electrode assembly method. After the computer simulation analysis is complete, it outputs an electrode assembly array. This electrode assembly array is a drawing file that marks the mounting holes 316 on the cap 3 where electrode clips 4 need to be installed, and indicates the size and shape of the electrode clips 4 that need to be installed in the corresponding mounting holes 316. This electrode assembly array is the final overall layout scheme of the electrode clips in step 3 above. The user will correctly install the electrode clips 4 according to the information provided by the electrode assembly array. Then, the electrode clips 4 are also connected to the electric field generating device 1. Specifically, after the output electrode array is assembled, the computer simulation analysis software will output the optimal electric field application scheme. The electric field generator 1 is connected to the computer through a data transmission line, and the newly acquired optimal electric field application scheme is transmitted to the electric field generator 1 through data interaction software. Thereafter, the optimal electric field application scheme of the user is stored in the electric field generator 1. After that, as long as the user turns on the head-mounted treatment device 100 to perform electric field therapy, the applied electric field will be applied according to the optimal electric field application scheme.

[0079] After the user's brain scan and the location of the surgical incision are input, the computer simulation analysis software will display something similar to... Figure 15 The image shown, Figure 15 The outer circular ring represents the top-down outline of the brain, with the tumor location (001) identified through image processing and the incision location (002) indicated by annotations within. Computer simulation analysis software analyzes information such as tumor location, size, depth, incision location, and area to output the electrode assembly array and the optimal electric field application scheme. The electrode assembly array will be explained below.

[0080] The process of formulating the electrode assembly array (i.e., the final overall layout scheme of the electrode buckles) in step 3 above includes: first, finding the corresponding tumor position 001 and incision position 002 in the array; determining the required electric field application area around the tumor position 001 and incision position 002; forming a preliminary electrode buckle 4 assembly area (i.e., a preliminary position assembly scheme) for the required electric field application area; then determining the electrode buckle 4 configuration scheme 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 to select the optimal combination scheme for the electric field; determining the final overall layout scheme of the electrode buckles 4; and outputting the electrode assembly array with the optimal electrode buckle 4 configuration.

[0081] Figure 16A This example shows an electrode assembly array output by computer simulation analysis software. The tumor location 001 marked on it 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 has not undergone surgery, there is no incision location. The quadrilateral ring surrounding the tumor location 001 and the incision location 002 represents all the assembly areas 003 calculated by the computer simulation analysis software where electrode clips 4 need to be installed. The outer frame of assembly area 003 is 003A, and the inner frame is 003B. After obtaining the assembly areas 003 of the electrode clips 4, the computer simulation analysis software calculates the configuration information of the electrode clips 4 that should be fitted to each mounting hole 316, based on adapting to different positions of the user's head and the maximum area of ​​the electric field covering the tumor site. This involves determining the shape and size of the electrode holder 41 that should be installed. This process will be explained in detail below.

[0082] The first step is to form the initial assembly area for electrode clip 4: (Refer to...) Figure 17 As shown, when determining the configuration area 003, the tumor location 001 and the incision location 002 are first excluded. Figure 16A For example, the mounting holes 316 marked A'0, A'+1, B'0, and B'+1 are excluded and do not require the installation of electrode clips 4. The main reason for this setting is that A'0 and B'0 are exactly within the area of ​​tumor location 001. Usually, before performing electric field therapy, the user's tumor is surgically removed. After the tumor is removed, the removed part is usually filled with cerebrospinal fluid, so there is usually a depression at A'0 and B'0 on the user's head. Therefore, it is difficult to ensure close contact between the electrode clips 4 and the user's skin when installing them at tumor location 001. Thus, the mounting point at tumor location 001 is preferentially discarded in the computer simulation analysis software.

[0083] Similarly, incision location 002 was also discarded because electric field therapy requires prolonged wear. Users typically begin electric field therapy shortly after tumor removal surgery, and the wound may not be fully healed at the start of treatment. Therefore, if electrodes were installed at A'+1 or B'+1, they would interfere with incision location 002, potentially leading to wound failure or infection. Even if the wound heals, the resulting scar at incision location 002 would be uneven, making it difficult to ensure close contact between electrode clip 4 and the user's skin. Therefore, for these reasons, the computer simulation analysis software prioritizes excluding the installation of electrode clip 4 at tumor location 001 and incision location 002.

[0084] After removing tumor location 001 and incision location 002, the computer simulation analysis software begins the next step of calculation and analysis, selecting a suitable electrode assembly area to ensure that the final applied electric field can generate as many changeable electric field directions as possible within the 360-degree direction of the tumor, thus achieving full coverage of the tumor and directional changeability of the electric field. Figure 18 and Figure 19 As shown, the example of electric field lines illustrates the multiple directions of electric fields that this electrode assembly array can generate. Based on the above conditions, computer simulation analysis software can determine multiple assembly areas for the electrode buckle 4 required by the user, thus completing the multiple preliminary position assembly schemes for the electrode buckle 4 in step 1.

[0085] Next, the configuration scheme of electrode buckle 4 was determined. After completing the above steps, the computer simulation analysis software obtained several preliminary position assembly schemes for electrode buckle 4, such as... Figure 18 and Figure 19 As shown. For the assembly scheme of each electrode buckle 4, besides knowing the mounting holes 316 that need to be covered, it is also necessary to determine the type of electrode holder 41 for each mounting hole 316 that needs to be installed on the electrode buckle 4. Figure 17 Taking the mounting holes in the middle as an example for explanation, see... Figure 20 As shown, the computer simulation analysis software will analyze and calculate the maximum area of ​​the electrode clip 4 that can be fitted into each mounting hole 316. Figure 20 The maximum size area of ​​the electrode holder 41 that can be fitted by the C'+2 mounting hole 316 is the mounting coverage area 004. After determining the size of the mounting coverage area 004, the computer simulation analysis software will retrieve the electrode holder 41 with the largest matching area from the database. Of course, in the calculation, in addition to considering the maximum coverage of the mounting coverage area, it will also consider the position and curvature of the head where the mounting hole 316 is located, to ensure 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, a large, hexagonal electrode holder 41 can be used at the mounting hole 316 marked C'+2.

[0086] The assembly coverage area of ​​each mounting hole 316 is mainly divided by the outer boundary line 005, the inner boundary line 006, and the dividing line 007. The outer boundary line 005 is the maximum boundary line that the selected mounting hole area can extend to the next mounting hole 316; the inner boundary line 006 is the minimum inner boundary line within the selected mounting hole area; and the dividing line 007 is the area dividing line based on the principle of equal division. In this example, the electrode holder 41 of the electrode buckle 4 includes both circular and polygonal shapes to select the appropriate electrode holder 41 for different assembly areas. Electrode buckles 4 located at corner positions often use polygonal electrode holders 41, while those located in the center often use circular electrode holders 41. Based on this, the computer simulation analysis software matches the optimal electrode buckle 4 configuration scheme to each electrode buckle 4 position assembly scheme, forming multiple sets of overall electrode buckle 4 layout schemes, thus completing step 2.

[0087] Next, electric field optimization analysis was performed. Computer simulation analysis software was used to further analyze and screen multiple electrode buckle 4 overall layout schemes based on previous calculations. The screening principle was focusing and coverage, primarily ensuring that the selected overall layout scheme, after installing the electrode buckles 4, could comprehensively focus and cover the tumor in all directions when an electric field was applied. (See reference...) Figure 21 As shown, two electrode clips 4 are installed in the two mounting holes 316, generating a regional electric field between them. The electric field lines E of this regional electric field must be able to completely cover the tumor 008. Furthermore, due to the size limitations of the electrode holders 41 of the electrode clips 4, they also have a focusing function, ensuring that the electric field covers as little of the non-tumor areas as possible. The computer simulation analysis software will prioritize excluding the following overall layout schemes based on these two principles: 1. Layout schemes where the generated electric field cannot completely cover the tumor or is not sufficiently focused; 2. Overall layout schemes where the generated electric field covers too much of the non-tumor area.

[0088] Next, an electric field optimization analysis is performed. Based on the above analysis and elimination process, the final overall layout scheme of the electrode buckle is determined. This mainly involves performing a final electric field analysis on multiple overall layout schemes of the electrode buckle that meet the requirements of the above steps. Under the same applied voltage, the analysis confirms which overall layout scheme can generate a larger electric field at the tumor site. For example, for Figure 18 and Figure 19 The electric field strength generated by the two schemes at various locations is compared, and the scheme with the largest electric field strength under the same applied voltage is selected as the superior one. (See reference...) Figure 22As shown, at position 011 corresponding to mounting hole 316 labeled A'+2, position 012 corresponding to mounting hole 316 labeled A'-1, and position 013 corresponding to mounting hole 316 labeled A'-2, the electric field coverage area generated from mounting hole 316 labeled A'+2 to mounting hole 316 labeled A'-1 is defined as field region 1. Simultaneously, the electric field coverage area generated from mounting hole labeled A'+2 to mounting hole labeled A'-2 is defined as electric field region 2. First from... Figure 22 As can be seen, the electric fields generated by both regions can cover tumor 008. However, based on the electrode distance analysis, the distance from mounting hole 316 marked A'+2 to mounting hole 316 marked A'-1 is significantly smaller than the distance from mounting hole 316 marked A'+2 to mounting hole 316 marked A'-2. According to the basic physical formula for electric field strength, E=U / d, the smaller the distance between the electrodes, the greater the electric field strength generated under the same voltage. Therefore, from the perspective of maximizing the electric field strength under the same applied voltage, Figure 18 The electrode assembly scheme in this paper is significantly superior to that in the past. Figure 19 The electrode assembly scheme in the system was thus determined. Figure 18 The electrode assembly scheme in the diagram is the final overall layout scheme of the electrode buckle, which outputs the electrode assembly array.

[0089] Next, we will explain in detail another file output by the computer simulation analysis software: the optimal electric field application scheme. The optimal electric field application scheme is the optimal electric field control method calculated by the computer simulation analysis software. It is transmitted to the electric field generator 1 via a data line. After that, the optimal electric field control method is stored in the electric field generator 1. Subsequently, every time the user turns on the electric field, the electric field generator 1 will apply an electric field to the user according to the internally stored optimal electric field control method in order to achieve optimal and precise electric field control.

[0090] Referring to Table 1, which provides an analysis of the optimal electric field application scheme, the computer simulation analysis software uses... Figure 15 The final calculated optimal electric field application scheme, specifically, assuming the time period for applying the electric field to the user is T, then within the time period T, the electric field application is divided into two directions, namely the Y direction (see...). Figure 23 ) and X direction (refer to) Figure 24The electric field applied in the Y direction has a period of 0.6T. This is achieved by connecting the electrode clips 4 at mounting holes 316 marked C'-1, C'0, C'+1, and C'+2 to the L phase of the electric field generator 1 at time 0, and connecting the electrode clips 4 at mounting holes 316 marked G'-1, G'0, G'+1, and G'+2 to the N phase of the electric field generator 1. The electrode clips 4 at the other mounting holes 316 are not electrically connected to the electric field generator 1. After the connections are completed, the electric field generator 1 begins to apply an AC voltage for a period of 0 seconds. At 0.6T, all electrode clips 4 at the connected mounting holes 316 are disconnected. Then, the electrode clips 4 at mounting holes 316 marked C'-1, B'-1, A'-1, and G'-1 are connected to the L phase of the electric field generator 1, and the electrode clips 4 at mounting holes 316 marked C'+2, B'+2, A'+2, and G'+2 are connected to the N phase of the electric field generator 1, thus switching the direction to the X direction. An AC voltage of 0.4T is then applied in this direction, completing the electric field application for the entire T cycle. The electric field is then applied cyclically in a controlled manner with a period of T. The computer simulation analysis software, considering that the tumor location is mainly concentrated in the Y direction and that the tumor volume is large in the Y direction, derived the optimal application scheme based on information such as the most likely direction of tumor spread: applying an electric field of 0.6T in the Y direction and an electric field of 0.4T in the X direction.

[0091] Table 1: Optimal Electric Field Application Scheme

[0092]

[0093] If, during a subsequent medical imaging examination, it is discovered that the user's tumor has spread beyond its original location, assuming the virtual head model image after scanning and annotation by computer simulation analysis software is as follows... Figure 25 As shown, from Figure 25 The tumor area was clearly observed to be larger than that in the tumor location 001'. Figure 15 The tumor at location 001 has enlarged, and computer simulation analysis software analyzed its possible directions of spread, such as... Figure 25 The image shows either tumor spread direction A (aligned with the X-axis) or tumor spread direction B (approximately counterclockwise at a 45° angle to the X-axis). Based on this, the computer simulation software will generate a new electrode assembly array and an optimal electric field application scheme. The new electrode assembly array and electrode holder assembly information table is shown below. Figure 26A and Figure 26B As shown, since the tumor has only slightly spread towards the mounting hole 316 marked B'+1, therefore Figure 26A The optimal electrode assembly array in the basic and Figure 16AThe results are consistent, except for the corresponding optimal electric field application schemes.

[0094] Table 2 shows the optimal electric field application scheme for another implementation method. Specifically, assuming the time period for applying the electric field to the user is T, the electric field application is divided into three directions within the time period T, namely the Y direction (see...). Figure 27 ), X direction (refer to) Figure 28 ), direction B (refer to) Figure 29 The electric field applied in the Y direction has a period of 0.3T. This is achieved by connecting the electrode clips 4 at the mounting holes 316 marked C'-1, C'0, C'+1, and C'+2 to the L phase of the electric field generator 1 at time 0, and connecting the electrode clips 4 at the mounting holes 316 marked G'-1, G'0, G'+1, and G'+2 to the N phase of the electric field generator 1. The electrode clips 4 at the other unrelated mounting holes 316 are not connected. After the connection is completed, the AC voltage is applied for a period of 0.3T. Then, at 0.3T, all connected electrode clips 4 are disconnected. Then, the electrode clips at the mounting holes 316 marked C'-1, B'-1, A'-1, and G'-1 are connected to the L phase of the electric field generator 1, and the electrode clips 4 at the mounting holes 316 marked C'+2, B'+2, A'+2, and G'+2 are connected to the N phase of the electric field generator 1. This switches the direction to the X direction, and then an AC voltage of 0.3T is applied in this direction. Then, at 0.6T (0.6T = 0.3T + 0.3T), all connected electrode clips 4 are disconnected. Next, the electrode clips 4 at mounting holes 316 marked B'-1, A'-1, G'-1, G'0, and G'+1 are connected to the L phase of the electric field generator 1, and the electrode clips 4 at mounting holes 316 marked C'0, C'+1, C'+2, B'+2, and A'+2 are connected to the N phase of the electric field generator 1. This switches the direction to the B direction (approximately counterclockwise at a 45° angle to the X-axis). An AC voltage of 0.4T is then applied in this direction, completing the electric field application for the entire T-cycle. The electric field is then applied cyclically according to the T-cycle control method. The computer simulation analysis software, based on the current direction of tumor spread and the size of the tumor in related directions, arranged the application time as follows: an electric field with a period of 0.3T is applied in the Y direction, an electric field with a period of 0.3T is applied in the X direction, and an electric field with a period of 0.4T is applied in the B direction.

[0095] Table 2: Optimal Electric Field Application Scheme Instructions After Tumor Location Spread

[0096]

[0097] Thus, this application achieves precise application of the electric field and eliminates unnecessary electrodes. The aforementioned free switching of direction is mainly achieved by the internal circuitry of the electric field generating device 1, which adds an electric field in the same direction as the tumor growth trend, and determines the selection of the mounting hole 316 based on the newly added electric field application direction.

[0098] The computer simulation analysis software primarily analyzes the tumor's growth direction and its size along each direction to determine the direction of electric field application and the time period for applying the electric field in each direction. For details, refer to... Figure 30 Regarding the tumor location 001', it has two main development directions: tumor development direction 1 and tumor development direction 2. The computer simulation analysis software will prioritize determining the two directions of electric field application: 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). It will also confirm whether each mounting hole 316 is in the L phase or N phase based on the previously determined electrode assembly array to ensure the system can smoothly output electric fields in these two directions. Having determined the electric field application directions, it also needs to determine the application time for each direction. The system sets the application time period to T, which is typically preferred to be T = 1s. The system will calculate the maximum tumor size in tumor development direction 1 as b, and the maximum tumor size in tumor development direction 2 as a. Therefore, the system will calculate the electric field application time period in tumor development direction 1 as: The time period for applying the electric field in tumor development direction 2 is: Thus, the computer simulation analysis software completed the determination of the direction and time of electric field application, and the analysis and calculation of the optimal electric field application scheme were completed. The computer simulation analysis software has confirmed the optimal electric field application scheme.

[0099] Figure 31 The diagram shows the internal circuitry of the electric field generator 1. Its internal circuitry 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 generator 1. (See also...) Figure 32As shown, the AC voltage generator produces the required AC voltage applied to the user's head. This is an alternating current signal. Since AC signals have no positive or negative polarity, the two output lines are defined as L-phase and N-phase for distinction. Each external electrode interface is connected to the L-phase and N-phase output of the AC voltage generator via switches 1 and 2, respectively. This means that each external electrode interface can be freely selected between being connected to the N-phase, connected to the L-phase, or not connected via program control. Furthermore, since each external electrode interface is connected to wire 2 when needed, and wire 2 connects to electrode clip 4, which in turn is fixed to the mounting hole 316 on the cap body 3, the AC signal applied to the electrode clip 4 at the mounting hole 316 can freely switch between L-phase, N-phase, and not connected. Based on this switching function combined with different electrode assembly positions, the electric field direction can be freely switched. Examples of 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, each of the mounting holes 316 on the cap body 3 corresponds one-to-one. The electrode assembly array, as output by the computer simulation analysis software, is connected to the electric field generating device 1 and the cap body 3 via wires 2, thus completing the process. Figure 14 The "Connecting Electrode and Electric Field Generator" step in the flowchart of the electric field application process is completed. After this step is completed, the electric field generator 1 can be turned on to perform electric field therapy.

[0100] The generation of electrode buckle positions and the electric fields generated for various combinations of electrode buckle positions in the above-mentioned electric field application methods largely rely on computer simulation. This method requires high computer hardware performance and is time-consuming because it needs to simulate the electric fields generated at each electrode buckle position. Therefore, the inventors have invented another electric field application method. This method determines the final electrode buckle layout scheme by actually measuring the current and voltage of the electric field generated by the paired electrode buckle groups, so as to improve the accuracy and efficiency of electric field therapy, reduce hardware requirements, and reduce costs.

[0101] The above are merely preferred embodiments of this application and are not intended to limit this application. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. A head-mounted treatment device adapted to apply an alternating electric field to a head tumor region, characterized by, include: An electric field generating device includes an AC voltage generator for generating an alternating current signal, a controller, a switch array, and a plurality of electrode interfaces, wherein the controller selectively transmits the alternating current signal to at least two of the plurality of electrode interfaces by configuring the state of the switch array. The cap body has a plurality of mounting holes corresponding one-to-one with the plurality of electrode interfaces; A plurality of electrode buckles are detachably assembled to the mounting holes of the cap body, wherein the assembly layout of each electrode buckle on the cap body is determined by a final overall electrode buckle layout scheme calculated based on the location and size of the user's brain tumor and stored in the electric field generating device. The assembly layout scheme of the electrode buckles includes the assembly position of each electrode buckle, the size of each electrode buckle, and the shape of each electrode buckle; and A plurality of wires are configured to: electrically connect each of the electrode buckles to the corresponding electrode interfaces according to the determined assembly position of each of the electrode buckles, and transmit alternating electrical signals transmitted to each of the electrode interfaces to the corresponding electrode buckles when the switch array electrically connected to each of the electrode interfaces is turned on.

2. The head-mounted treatment device of claim 1, wherein, The final overall layout scheme of the electrode buckles is determined by actually measuring the current and voltage of the electric field generated by the paired electrode buckles; or the final overall layout scheme of the electrode buckles is determined by obtaining the optimal electric field application scheme by computer simulation analysis software based on the three-dimensional model reconstructed from the image data related to the user's target area and the skin surface condition, and by performing electric field generation simulation on the reconstructed three-dimensional model.

3. The head-mounted treatment device of claim 2, wherein, The final overall layout scheme of the electrode buckle is determined based on whether each electric field in the electric field generation simulation fully covers the target area, whether it covers a lot of non-target areas, and whether the field strength generated in the simulation is the maximum.

4. The head-mounted treatment device of claim 3, wherein, The optimal electric field application scheme is also determined based on the size of the target region and / or the expansion direction of the target region, wherein the expansion direction of the target region is determined based on medical image data of the user's target region at different stages.

5. The head-mounted treatment device according to claim 3, characterized in that, The optimal electric field application scheme includes the direction of electric field application, the time of electric field application in each direction, and the electric field switching period in each direction.

6. The head-mounted treatment device according to claim 1, characterized in that, The AC voltage generator has an L-phase output and an N-phase output, and the electrode interface has three connection states with the AC voltage generator: connected to the L-phase output, connected to the N-phase output, and not connected.

7. The head-mounted treatment device according to claim 6, characterized in that, The controller controls each electrode interface to freely switch between being connected to the L-phase output of the AC voltage generator, being connected to the N-phase output of the AC voltage generator, and not being connected to the AC voltage generator via the switch array.

8. The head-mounted treatment device according to claim 1, characterized in that, The cap has an arc-shaped coverage area that covers the user's head from the root of the nose to the occipital protuberance, and the mounting holes are distributed in the upper 80% area of ​​the arc-shaped coverage area.

9. The head-mounted treatment device according to claim 8, characterized in that, The cap body is also provided with several perforated holes for heat dissipation.

10. The head-mounted therapeutic device according to any one of claims 1 to 9, characterized in that, The electrode buckle includes a fixed cover that fits together with an electrode base. The electrode base extends through the mounting hole from the side of the cap body facing the user's head and is detachably assembled onto the cap body by snapping its corresponding part against the edge of the cap body located around the mounting hole.

11. The head-mounted therapeutic device according to claim 10, characterized in that, The fixing cap is detachably fixed to the top of the electrode holder from the side of the cap body away from the user's head.

12. The head-mounted therapeutic device according to claim 11, characterized in that, The wire is plugged into the corresponding electrode interface through a plug at one end, and inserted into the opening of the fixing cover through a conductive piece at the other end, making contact with the top of the electrode holder.

13. The head-mounted therapeutic device according to claim 12, characterized in that, The conductive sheet has a contact portion, the top of the electrode holder has a recess corresponding to the contact portion, and the fixing cover has a pressing portion corresponding to the contact portion, the pressing portion pressing the contact portion against the recess.

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