Tumor electric field therapy device, treatment system, and method for manufacturing the treatment device

Abstract

This invention discloses a tumor electric field therapy device and system. The tumor electric field therapy device consists of a frame and electrode modules. The frame forms the skeleton structure of the therapy device, and the electrode modules are attached to the frame. Each electrode module has several electrode contacts, and each electrode contact can be either an active or passive contact. The active contacts can form a circuit with a radio frequency generation module. When the therapy device is implanted into the tumor resection site, all electrode contacts become active contacts, and each electrode contact forms a circuit with the radio frequency generation module, distinguishing between normal tissue and diseased tissue. After distinguishing between normal tissue and diseased tissue, the electrode contacts in the normal tissue area become passive contacts, and the electrode contacts in the diseased tissue area become active contacts, enabling targeted treatment of the diseased tissue and thus reducing the side effects of electric field therapy.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a tumor electric field therapy device, a treatment system, and a method for manufacturing the treatment device. Background Technology

[0002] Currently, malignant tumor treatments only involve removing the proliferating tissue through surgery and radiotherapy, which does not effectively alleviate the patient's condition. Tumor electric field therapy (TTF) devices, by applying an alternating electric field to the tumor site, can inhibit the proliferation of malignant tumors to a certain extent, greatly increasing the patient's survival time and providing a new approach to the treatment of malignant tumors.

[0003] Tumor electric field therapy (TTF), as an emerging treatment method, has shown positive effects in some tumor types, especially in the treatment of gliomas. For example, the tumor electric field therapy system disclosed in patent document CN216653129U involves an electric field generating module and an electrode patch assembly electrically connected to the module. The electrode patch is attached to the patient's body surface corresponding to the tumor site via a backing, and an alternating electric field is applied to the tumor site through the electrode functional components to interfere with or inhibit the mitosis of tumor cells, thereby achieving the purpose of treating the tumor.

[0004] Although existing tumor electric field therapy (TTF) has brought some positive effects to the treatment of tumors, TTF applies an electric field to the entire head by attaching large electrodes to the scalp to inhibit malignant tumors. It does not apply targeted, small-scale electric field treatment to the lesion area. When the human body is exposed to the electric field for a long time, it may cause a series of side effects, such as contact dermatitis and neurological dysfunction. Summary of the Invention

[0005] The purpose of this invention is to overcome the above-mentioned technical deficiencies and to propose a tumor electric field therapy device, a treatment system, and a method for manufacturing the treatment device, thereby solving the technical problem that tumor electric field therapy in the prior art is difficult to target the lesion area.

[0006] To achieve the above-mentioned technical objectives, the present invention adopts the following technical solution:

[0007] In a first aspect, the present invention provides a tumor electric field therapy device, comprising:

[0008] Frame, for implantation at the tumor resection site; and

[0009] An electrode module is attached to the frame. The electrode module is provided with a number of electrode contacts. Each electrode contact is connected to or not connected to the radio frequency generation module to form an active contact or a passive contact. The active contact is used to form a circuit with the radio frequency generation module and generate current at the tumor resection site.

[0010] In some embodiments, the frame is an expandable or contractible cystic structure, which can be implanted into the tumor resection site through the contraction of the cystic structure. The electrode module is a flexible electrode, which can be attached to the tumor resection site through the expansion of the cystic structure.

[0011] In some embodiments, the frame includes a plurality of elastic bodies, which are sequentially connected and enclosed to form the capsule structure. The frame can expand or contract the capsule structure by the deformation of each elastic body.

[0012] In some embodiments, a liquid accumulation cavity is formed on the inner side of the frame, and a liquid passage gap is formed between each of the elastomers, the liquid passage gap communicating with the liquid accumulation cavity.

[0013] In some embodiments, the electrode module includes a plurality of flexible electrodes connected in sequence, each flexible electrode being attached to each of the elastomers, and each electrode contact being disposed on each of the flexible electrodes.

[0014] Secondly, the present invention also provides a tumor electric field therapy system, comprising:

[0015] The aforementioned tumor electric field therapy device;

[0016] Circuit board, connected to the electrode module;

[0017] An electric field generating module is disposed on the circuit board and is used to energize the electrode module so that the electrode module generates an electric field through each electrode contact.

[0018] A radio frequency (RF) generator module, disposed on the circuit board, is used to energize the electrode module to generate current between the electrode contacts forming active contacts.

[0019] In some embodiments, the circuit board is provided with a CMOS semiconductor, which is connected to the connection portion via a microstrip line.

[0020] In some embodiments, the tumor electric field therapy system further includes a fluid aspiration microfluidic tube, which is fixed to the frame and extends to the effusion cavity for aspirating cerebrospinal fluid from the effusion cavity.

[0021] In some embodiments, the tumor electric field therapy system further includes a drug delivery microfluidic tube fixed to the frame and extending to the lesion area for administering drug to the lesion area.

[0022] Thirdly, the present invention also provides a method for manufacturing a tumor electric field therapy device, comprising the following steps:

[0023] S100: The frame is formed by machining;

[0024] S200: The electrode module is formed based on MEMS technology;

[0025] S300: Apply glue to the frame;

[0026] S400: Attach the electrode module to the frame;

[0027] S500: Release the frame from the mold.

[0028] Compared with existing technologies, the tumor electric field therapy device provided by this invention uses a frame and electrode modules. The frame forms the skeleton structure of the therapy device, enabling implantation into the tumor resection site and providing support. The electrode modules are attached to the frame and have several electrode contacts, each of which can be active or passive. The active contacts can form a circuit with the radio frequency generation module. After the therapy device is implanted into the tumor resection site, all electrode contacts become active contacts, and each electrode contact forms a circuit with the electric field generation module. Powered by the electric field generation module, an electric field is continuously provided to the tumor resection site to inhibit the growth of cancer cells at the tumor resection site. Since the impedance value of cancer cells in tumor tissue is usually greater than positive impedance, this invention provides a more effective solution. The impedance value of normal tissue cells results in a relatively small current value between the active contacts in the diseased tissue area, thus distinguishing between normal and diseased tissue. After distinguishing between normal and diseased tissue, the electrode contacts in the normal tissue area become passive contacts, while the electrode contacts in the diseased tissue area become active contacts. This allows for the separate generation of an alternating frequency current in the diseased tissue area, enabling targeted alternating frequency current treatment and ablation of cancer cells in the diseased tissue area. The tumor electric field therapy system uses a radio frequency generation module to separately energize the diseased tissue area, achieving targeted alternating frequency current treatment and thus targeted ablation of cancer cells in the diseased tissue, thereby reducing the side effects of electric field therapy. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of the structure of the tumor electric field therapy device provided in an embodiment of the present invention;

[0030] Figure 2 This is a schematic diagram of the frame of the tumor electric field therapy device provided in an embodiment of the present invention;

[0031] Figure 3 This is a schematic diagram of the electrode module of the tumor electric field therapy device provided in an embodiment of the present invention;

[0032] Figure 4 This is a schematic diagram of the electrode module of a tumor electric field therapy device provided in another embodiment of the present invention;

[0033] Figure 5 This is a distribution diagram of the electrode contacts of the flexible electrode in the tumor electric field therapy device provided in this embodiment of the invention;

[0034] Figure 6 This is a diagram of the electrode contacts of the flexible electrode of a tumor electric field therapy device provided in another embodiment of the present invention;

[0035] Figure 7 This is a schematic diagram of step (a) of the forming process of the electrode module of the tumor electric field therapy device provided in the embodiment of the present invention;

[0036] Figure 8 This is a schematic diagram of step (b) of the forming process of the electrode module of the tumor electric field therapy device provided in this embodiment of the invention;

[0037] Figure 9 This is a schematic diagram of step (c) of the forming process of the electrode module of the tumor electric field therapy device provided in the embodiment of the present invention;

[0038] Figure 10 This is a schematic diagram of step (d) of the forming process of the electrode module of the tumor electric field therapy device provided in the embodiment of the present invention;

[0039] Figure 11 This is a schematic diagram of step (e) of the forming process of the electrode module of the tumor electric field therapy device provided in the embodiment of the present invention;

[0040] Figure 12 This is a schematic diagram of step (f) of the forming process of the electrode module of the tumor electric field therapy device provided in the embodiment of the present invention;

[0041] Figure 13 This is a schematic diagram of step (g) of the forming process of the electrode module of the tumor electric field therapy device provided in the embodiment of the present invention;

[0042] Figure 14 This is a schematic diagram of the structure of the tumor electric field therapy system provided in an embodiment of the present invention;

[0043] Figure 15 This is a flowchart of the manufacturing method of the tumor electric field therapy device provided in the embodiments of the present invention. Detailed Implementation

[0044] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0045] Existing tumor electric field therapy (TTF) uses large electrodes attached to the scalp to apply an electric field to the entire head to inhibit malignant tumors. However, it does not apply targeted, small-scale electric field therapy to the lesion area, which easily leads to a series of side effects. In order to solve the technical problem that existing tumor electric field therapy is difficult to target the lesion area, this invention provides a tumor electric field therapy device. The tumor electric field therapy device can target the lesion tumor tissue area with electric field therapy, thereby reducing the side effects of tumor electric field therapy.

[0046] It should be noted that the tumor electric field therapy device described in this invention is used for, but not limited to, the treatment of brain tumor tissue. For ease of explanation, this invention will only use the application of the tumor electric field therapy device to the treatment of brain tumor tissue as an example. The principle of the tumor electric field therapy device applied to other types of devices is essentially the same as that applied to the treatment of brain tumor tissue, and will not be described in detail here.

[0047] The tumor electric field therapy device provided in the embodiments of the present invention, such as Figure 1 As shown, the device includes a frame 10 and an electrode module 20. The frame 10 is used for implantation at the tumor resection site. The electrode module 20 is attached to the frame 10 and is provided with a number of electrode contacts 21. Each electrode contact 21 forms an active contact 211 or a passive contact 212 by connecting or not connecting to the radio frequency generation module. The active contact 211 is used to form a circuit with the radio frequency generation module to generate current at the tumor resection site.

[0048] Specifically, the tumor electric field therapy device comprises a frame 10 and electrode modules 20. The frame 10 forms the skeleton structure of the therapy device, enabling implantation into the tumor resection site and providing support for the therapy device. The electrode modules 20 are attached to the frame 10 and are equipped with several electrode contacts 21, each of which can form an active contact 211 or a passive contact 212. The active contacts 211 can form a circuit with the radio frequency generation module. After the therapy device is implanted into the tumor resection site, each electrode contact 21 is connected to the radio frequency generation module, continuously generating an electric field under the power supply of the electric field generation module to inhibit the growth of cancer cells at the tumor resection site. Since the impedance value of cancer cells in tumor tissue is usually greater than that of normal tissue cells, the current value formed between the active contacts 211 in the lesion tissue area 10a is relatively small. Figure 5-6As shown, normal tissue areas and diseased tissue areas 10a can be distinguished; after distinguishing between normal tissue areas and diseased tissue areas 10a, the electrode contact 21 in the normal tissue area is made into a passive contact 212, as shown. Figure 5-6 As shown, the electrode contact 21 of the lesion tissue region 10a forms an active contact 211. The active contact 211 of the lesion tissue region 10a can form an alternating current through the circuit formed with the radio frequency generation module, while the passive contact 212 of the normal tissue region does not form a current or forms a low-voltage current as needed. Thus, an alternating current is separately applied to the lesion tissue region 10a, thereby ablation of the lesion tumor tissue cells, achieving targeted treatment of the lesion tumor tissue, effectively reducing the side effects of electric field therapy, and reducing the damage caused by electric field therapy to the human body.

[0049] In this embodiment, as Figure 5-6 As shown, the active contact 211 includes a positive contact and a negative contact. The positive contact is connected to the output terminal of the RF generator module to receive RF current, and the negative contact is connected to the ground terminal of the RF generator module to form a loop with the positive contact to generate a high-intensity alternating current.

[0050] When performing targeted treatment on the lesion area 10a, for the proliferating tumor tissue, the radiofrequency generation module adjusts the amplitude, phase, current and power of the radiofrequency signal according to the size, shape and distance between the positive and negative contacts of the lesion area, so that the lesion tissue moves and oscillates at a high speed at the same frequency as the radiofrequency current, generating frictional heat, which causes the internal temperature of the tumor tissue to rise and ablate the lesion tissue in the proliferating area.

[0051] For tissues without proliferation, the active contact 211 at the center can be grounded as a negative contact, while the other active contacts 211 around it can be grounded as positive contacts connected to the positive voltage of the electric field generating module, forming an electric field with an electric field strength of 1-3V / cm and an alternating frequency of 100K-300KHz. This can interfere with the mitotic process of cancer cells, thereby inhibiting the proliferation of tumor cells at the lesion site and inducing cancer cell death.

[0052] Understandably, the frame 10 can be any structure, such as a plate or rod, that can be implanted at the tumor resection site and for attaching the electrode module.

[0053] Understandably, the electrode module 20 can be an electrode structure of any material and shape, as long as it can adhere to the surface of the frame 10.

[0054] In one embodiment, such as Figure 1-2As shown in Figure 14, the frame 10 is an expandable or contractible cystic structure. The frame 10 can be implanted into the tumor resection site through the contraction of the cystic structure. The electrode module 20 is a flexible electrode 22. The electrode module 20 can be attached to the tumor resection site through the expansion of the cystic structure.

[0055] Specifically, by configuring the frame 10 as an expandable or contractible sac structure, when the treatment device is implanted, the frame 10 contracts to form a strip structure, thereby reducing its volume, facilitating implantation, and minimizing implantation trauma. After implantation, the treatment device can expand according to the size of the tumor resection site, allowing each electrode contact 21 to fit well with the tissue. During tissue recovery, the frame 10 can be compressed to contract, reducing its volume and avoiding obstruction to tissue growth and recovery. By configuring the electrode module 20 as a flexible electrode 22, it can adapt well to the expansion and contraction of the frame 10, ensuring stable contact with the frame 10 during expansion and contraction. This ensures that even when the frame 10 expands and contracts, the electrode contacts 21 at the lesion site on the electrode module 20 remain above the lesion site, preventing the expansion and contraction of the frame 10 from affecting the treatment of the lesion area.

[0056] Understandably, the frame 10 can be a sealed air bladder or liquid bladder structure, which expands by inflating the inside of the frame 10 with air or liquid and contracts by venting or draining the air or liquid.

[0057] In one embodiment, such as Figure 1-2 As shown in Figure 14, the frame 10 includes a plurality of elastic bodies 11, which are sequentially connected and enclosed to form the capsule structure. The frame 10 can expand or contract the capsule structure through the deformation of each elastic body 11.

[0058] Specifically, the scaffold 10 expands or contracts through the elasticity of each elastomer 11, thus adaptively expanding and contracting according to the size of the tumor resection site. This adaptively adjusts the adhesion between the electrode module 20 and the tissue site, facilitating tissue growth and the acquisition of the lesion area. Furthermore, the expansion and contraction of the scaffold 10 itself eliminates the need for a sealed cystic structure, making it easier for the scaffold 10 to form a non-sealed cystic structure. This non-sealed cystic structure allows interstitial fluids to pass through the scaffold 10 without hindering the flow and exchange of interstitial fluids.

[0059] In this embodiment, the frame 10 expands or contracts by the deformation of the middle part of each elastic body 11. Extreme contraction can form a strip structure, and extreme expansion can form a spherical capsule structure.

[0060] Understandably, elastomer 11 may include, but is not limited to, biocompatible elastic materials such as nickel-titanium alloys, cobalt alloys, and magnesium alloys.

[0061] In one embodiment, such as Figure 1-2 As shown in Figure 14, an effusion cavity 12 is formed on the inner side of the frame 10, and a fluid passage gap 13 is formed between each elastic body 11, which communicates with the effusion cavity 12. Specifically, by forming the effusion cavity 12 on the inner side of the frame 10 and the fluid passage gap 13 between each elastic body 11, cerebrospinal fluid formed by the diseased tissue can enter the effusion cavity 12 through the fluid passage gap 13, thereby facilitating the drainage of cerebrospinal fluid and accelerating the treatment of effusion in the diseased area.

[0062] In this embodiment, since the tissue part is attached to the frame 10, the cerebrospinal fluid in the effusion cavity 12 can be prevented from flowing out of the fluid passage gap 13 by the obstruction of the tissue part.

[0063] In one embodiment, to accommodate the deformation of each elastomer 11, such as Figure 1 , 3 As shown in Figures 4 and 14, the electrode module 20 includes a plurality of sequentially connected flexible electrodes 22, each flexible electrode 22 being attached to a respective elastic body 11, and each electrode contact 21 being disposed on a respective flexible electrode 22. Specifically, during the deformation of each elastic body 11, it will cause the attached flexible electrodes 22 to deform synchronously.

[0064] Understandably, the number of flexible electrodes 22 is matched with the number of elastomers 11, and their size can be adapted to the size of the tumor resection site. The number of electrode contacts 21 on each flexible electrode 22 can be 22, 44 or 86. Each electrode contact 21 is arranged in an array and distributed at both ends of the flexible electrode 22 to achieve functions such as precise acquisition and ablation of the lesion area.

[0065] Understandably, the active contacts 211 and passive contacts 212 of each electrode contact 21 can be formed by surgery or contact control module. The positive contact of the active contact 211 is formed by connecting to the output terminal of the radio frequency generation module, and the negative contact of the active contact 211 is formed by connecting to the ground terminal of the radio frequency generation module.

[0066] In one embodiment, such as Figure 1 , 3 As shown in Figures 4 and 14, the electrode module 20 is also provided with a connecting part 23, which connects each flexible electrode 22. Specifically, the connecting part 23 can realize the series connection of each flexible electrode 22, so that the circuit board only needs to be connected to the connecting part 23, which facilitates the connection between each flexible electrode 22 and the circuit board.

[0067] In this embodiment, the connection part 23 is provided with a microstrip line, which is flip-soldered to the CMOS (complementary metal-oxide-semiconductor) to realize the control of the high-channel electrode and signal acquisition.

[0068] like Figure 1 and 3 As shown in Figure 4, in this embodiment, the connecting part 23 is connected to the upper end or the middle of each flexible electrode 22, and is not limited to the upper end or the middle of the flexible electrode 22, but can also be any part of the flexible electrode 22.

[0069] This invention also provides a tumor electric field therapy system, including a circuit board 30, a radio frequency generation module, a radio frequency generation module, and the aforementioned tumor electric field therapy device. The circuit board 30 is connected to the electrode module 20 of the tumor electric field therapy device. The electric field generation module is disposed on the circuit board and is used to energize the electrode module so that the electrode module forms an electric field through each electrode contact. The radio frequency generation module is disposed on the circuit board 30 and is used to energize the electrode module 20 so that a current is formed between each electrode contact 21 forming an active contact 211.

[0070] Specifically, after the treatment device is implanted into the tumor resection site, all electrode contacts 21 form active contacts 211, and each electrode contact 21 forms a circuit with the electric field generating module. The electric field generating module supplies power to each electrode contact 21, causing an electric field to be formed between each electrode contact 21. Since the impedance value of cancer cells in tumor tissue is usually greater than that of normal tissue cells, the current value formed between the active contacts 211 in the lesion tissue area 10a is relatively small, thus distinguishing normal tissue from lesion tissue. After distinguishing normal tissue from lesion tissue, the electrode contacts 21 in the normal tissue area form passive contacts 212, and the electrode contacts 21 in the lesion tissue area 10a form active contacts 211. The active contacts 211 in the lesion tissue area 10a can generate current through the circuit formed with the radio frequency generating module, while the passive contacts 212 in the normal tissue area cannot generate current. This enables the lesion tissue area 10a to be energized independently, achieving targeted treatment of the lesion tumor tissue, effectively reducing the side effects of electric field therapy, and reducing the damage caused by electric field therapy to the human body.

[0071] In this embodiment, the circuit board 30 is also equipped with a charging circuit, a data processing circuit, a wireless communication circuit, a power management circuit, a pulse generation circuit, and a flip-solder contact array. The data processing module in the PCB circuit processes the electrode acquisition signals transmitted by the microstrip line 32. The wireless communication module enables real-time, rapid, and accurate extraction of nerve signals to minimize transmission loss and noise. The power management circuit controls the on / off state of each module according to the operating mode. The pulse generation circuit applies high-frequency pulse signals to the implanted electrode module to achieve tumor inhibition and ablation functions.

[0072] In this embodiment, a contact control module is also provided on the circuit board 30. The contact control module is used to control each electrode contact 21 to form an active contact 211 or a passive contact 212.

[0073] In one embodiment, the circuit board 30 is provided with a CMOS semiconductor 31, which is connected to the connection portion 23 via a microstrip line 32. Specifically, the electrode module, by connecting to the CMOS semiconductor 31, can realize the control and signal acquisition of the high-channel electrode module.

[0074] In this embodiment, the CMOS semiconductor 31 is fixed to the flip-chip contact array of the circuit board 30 by flip-chip bonding process.

[0075] In this embodiment, the tumor electric field therapy system also includes a power supply device 40, which is connected to the circuit board 30 and is used to supply power to the circuit board 30.

[0076] In one embodiment, the tumor electric field therapy system further includes a fluid aspiration microfluidic tube 50, which is fixed to the frame 10 and extends to the effusion cavity 12 for aspirating cerebrospinal fluid from the effusion cavity 12. Specifically, by aspirating cerebrospinal fluid from the effusion cavity 12, the fluid aspiration microfluidic tube 50 can prevent increased intracranial pressure caused by cerebrospinal fluid after tumor surgery, thereby reducing complications caused by increased intracranial pressure after tumor surgery.

[0077] In one embodiment, the tumor electric field therapy system further includes a drug delivery microfluidic tube 60, which is fixed to the frame 10 and extends to the lesion area for drug delivery to the lesion area. Specifically, the drug delivery microfluidic tube 60 enables precise drug delivery to the lesion area, thereby reducing the side effects caused by chemotherapy drugs.

[0078] In one embodiment, the tumor electric field therapy system further includes a pumping device 70, which is connected to a fluid extraction microfluidic tube and a drug delivery microfluidic tube 60 to realize the extraction of cerebrospinal fluid and drug delivery to the lesion area.

[0079] This invention also provides a method for manufacturing a tumor electric field therapy device, such as... Figure 15 As shown, it includes the following steps:

[0080] S100: The frame is formed by machining;

[0081] S200: The electrode module is formed based on MEMS technology;

[0082] S300: Apply glue to the frame;

[0083] S400: Attach the electrode module to the frame;

[0084] S500: Release the frame from the mold.

[0085] Specifically, through the above process steps, a treatment device capable of targeted treatment of tumor tissue areas can be formed, effectively reducing the damage caused to the human body by electric field therapy.

[0086] In this embodiment, during the process of forming the frame 10, the frame 10 can be prepared using tubes with diameters of 0.5cm, 1cm, 2cm, 3cm, etc., and made of materials such as nickel-titanium alloy, cobalt alloy, and magnesium alloy. During preparation, the surface of the tube is first cut using laser cutting technology to form a semi-finished frame 10 with a balloon structure. The semi-finished frame 10 is then post-processed, including but not limited to heat treatment, pickling, sandblasting, and polishing, to increase the surface smoothness of the balloon frame 10 and prevent friction and cutting damage caused by the rough surface of the balloon frame 10 after implantation.

[0087] In this embodiment, the electrode module 20 and the microstrip line are fabricated on the PI flexible electrode 22 using MEMS (Micro-Electro-Mechanical Systems) technology to realize functions such as detection, electric field suppression, and ablation of the treatment device. The specific MEMS process flow of the electrode module is as follows:

[0088] (a) such as Figure 7 As shown, a substrate 301 is prepared, and the substrate material includes, but is not limited to, silicon wafers, quartz wafers, silicon carbide, etc. An oxide layer 302 is prepared on the surface of the silicon wafer as a dielectric layer;

[0089] (b) such as Figure 8 As shown, a first flexible substrate material 303 is prepared on the surface of a wafer substrate 301. The substrate material 303 may include, but is not limited to, PI, PDMS, silicone resin, etc. The electrode module substrate shape is prepared by performing steps such as homogenization, photolithography, and development on the substrate material 303.

[0090] (c) such as Figure 9 As shown, metal electrodes and metal wiring 304 are fabricated by depositing metal on the surface of substrate material 303. The deposited metal can be any one or more combinations of gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, titanium alloy, graphite, and carbon nanotubes, and the deposited metal is patterned.

[0091] (d) such as Figure 10 As shown, a metal electrode surface is modified with a material 305, and the deposited material 305 is patterned. The material 305 includes, but is not limited to, one or more of platinum, titanium nitride, and iridium oxide.

[0092] (e) such as Figure 11As shown, an insulating layer 306 is spin-coated. The insulating layer 306 may include, but is not limited to, PI, PDMS, silicone resin, etc. The insulating layer is then homogenized, photolithographically etched, and developed, and the cavity is prepared by RIE etching.

[0093] (f) such as Figure 12 As shown, indium metal is deposited, and the metal surface is uniformly coated, photolithographically etched, and developed. The indium metal is patterned using a dry etching method to form a CMOS flip-chip array 307.

[0094] (g) such as Figure 13 As shown, the substrate material 303 is released from the substrate 301. The release process can be carried out by any one or a combination of mechanical, physical or chemical methods to complete the fabrication of the flexible electrode module 20.

[0095] Through the above manufacturing process, while realizing the fabrication of the flexible electrode module 20, the number of electrode contacts can be guaranteed.

[0096] In this embodiment, before the electrode module is pasted onto the frame, the finished frame 10 is flattened on the mold.

[0097] In this embodiment, in the step of pasting the electrode module 20, a biocompatible adhesive is evenly applied to the frame 10, and the prepared flexible electrode module 20 is pasted onto the frame 10 and cured. The biocompatible adhesive may include, but is not limited to, UV curing adhesive, biocompatible epoxy resin cyanoacrylate, etc. After curing, the balloon frame 10 is released from the mold by physical or chemical means, and the surface of the frame 10 is cleaned.

[0098] In this embodiment, after the tumor electric field therapy device is formed, the indium pillar solder joints of the wires of the flexible electrode 22 are soldered to the CMOS using a flip-chip bonding process. Then, the liquid extraction microfluidic tube 50 and the drug delivery microfluidic tube 60 are fixed to the frame 10, thus forming the tumor electric field therapy system of this embodiment.

[0099] To better understand this invention, the following is combined with... Figure 1-6Section 14 provides a detailed description of the technical solution of the present invention: In the treatment of tumor tissue, the tumor tissue is first removed through conventional tumor resection surgery. The contracted treatment device is then implanted into the tumor resection site through the surgical incision. The treatment device expands into a balloon shape, allowing the electrode module to attach to the tissue after tumor resection. Due to the unlimited proliferation and dense arrangement of cancer cells, tumor tissue requires a large amount of free water to promote division; therefore, its impedance value is usually greater than that of normal tissue. By powering the electric field generation module to each electrode contact, the impedance value of the tumor resection site at different frequencies is measured to distinguish between normal tissue and diseased tissue, and to determine the size, shape, and state of the proliferating tumor at the tumor resection site. The electrode contact 21 controlling the lesion tissue is an active contact 211, and the electrode contact 21 controlling the normal tissue is a passive contact 212. The positive contact of the active contact 211 is connected to the output terminal of the radio frequency generation module and receives the radio frequency ablation current from the radio frequency generation module. The negative contact is connected to the ground terminal of the radio frequency generation module and forms a circuit with the positive contact. The radio frequency generation module adjusts the amplitude, phase, current and power of the radio frequency signal according to the size and shape of the lesion area and the distance between the positive and negative contacts, so that the lesion tissue moves and oscillates at a high speed at the same frequency as the radio frequency current to generate frictional heat, so that the internal temperature of the tumor tissue rises and ablates the lesion tissue in the proliferating area.

[0100] The tumor electric field therapy system also uses a microfluidic tube 50 to aspirate cerebrospinal fluid from the tumor resection site, preventing increased intracranial pressure due to cerebrospinal fluid after tumor surgery and reducing complications caused by elevated intracranial pressure. Simultaneously, for non-proliferating postoperative tissue, while applying a tumor-suppressing electric field, a drug delivery microfluidic tube 60 precisely delivers medication to the postoperative lesion area, reducing systemic side effects caused by chemotherapy drugs.

[0101] The specific embodiments of the present invention described above do not constitute a limitation on the scope of protection of the present invention. Any other corresponding changes and modifications made in accordance with the technical concept of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. A tumor electric field therapy system, characterized in that, include: A tumor electric field therapy device includes a frame and an electrode module. The frame is used for implantation at the tumor resection site. The electrode module is attached to the frame and is provided with a plurality of electrode contacts. Each electrode contact is connected to or not connected to a radio frequency generation module to form an active contact or a passive contact. The active contact is used to form a circuit with the radio frequency generation module and generate a current at the tumor resection site. Circuit board, connected to the electrode module; An electric field generating module is disposed on the circuit board and is used to energize the electrode module so that the electrode module generates an electric field through each electrode contact. A radio frequency generation module, disposed on the circuit board, is used to power the electrode module so that current is formed between the electrode contacts that form active contacts; and A contact control module is used to control each electrode contact to form an active contact or a passive contact. When the tumor electric field therapy device is implanted into the tumor resection site, each electrode contact forms a circuit with the electric field generation module. The electric field generation module supplies power to each electrode contact to create an electric field between the electrode contacts, thereby inhibiting the growth of cancer cells in the tumor resection site. The impedance value of the tumor resection site at different frequencies is measured by supplying power to each electrode contact through the electric field generation module, thus distinguishing between normal tissue areas and diseased tissue areas. After distinguishing between normal tissue areas and diseased tissue areas, the electrode contacts in the normal tissue areas become passive contacts, while the electrode contacts in the diseased tissue areas become active contacts.

2. The tumor electric field therapy system according to claim 1, characterized in that, The frame is an expandable or contractible cystic structure. The frame can be implanted into the tumor resection site through the contraction of the cystic structure. The electrode module is a flexible electrode. The electrode module can be attached to the tumor resection site through the expansion of the cystic structure.

3. The tumor electric field therapy system according to claim 2, characterized in that, The frame includes a plurality of elastic bodies, which are sequentially connected and enclosed to form the capsule structure. The frame can expand or contract the capsule structure by deforming each of the elastic bodies.

4. The tumor electric field therapy system according to claim 3, characterized in that, A liquid accumulation cavity is formed on the inner side of the frame, and a liquid passage gap is formed between each of the elastic bodies, the liquid passage gap being in communication with the liquid accumulation cavity.

5. The tumor electric field therapy system according to claim 3, characterized in that, The electrode module includes a plurality of flexible electrodes connected in sequence, each of the flexible electrodes being attached to each of the elastic bodies, and each of the electrode contacts being disposed on each of the flexible electrodes.

6. The tumor electric field therapy system according to claim 5, characterized in that, The electrode module is also provided with a connection part, which connects to each flexible electrode. The connection part is provided with a microstrip line. The circuit board is provided with a CMOS semiconductor, which is connected to the connection part through the microstrip line.

7. The tumor electric field therapy system according to claim 1, characterized in that, The tumor electric field therapy system also includes a fluid aspiration microfluidic tube, which is fixed to the frame and extends to the effusion cavity for aspirating cerebrospinal fluid from the effusion cavity.

8. The tumor electric field therapy system according to claim 1, characterized in that, The tumor electric field therapy system also includes a drug delivery microfluidic tube, which is fixed to the frame and extends to the lesion area for drug delivery to the lesion area.

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