Tumor electric field treatment device, treatment system and manufacturing method of treatment device

Abstract

The invention discloses a tumor electric field treatment device and system, the tumor electric field treatment device is provided with a frame body and a pole piece module, the frame body forms a skeleton structure of the treatment device, the pole piece module is attached to the frame body, the pole piece module is provided with a plurality of electrode contacts, and each electrode contact can form an active electric contact or a passive electric contact. The active electric contact and the radio frequency generation module can form a loop; after the treatment device is implanted into a tumor excision part, all the electrode contacts form active electric contacts, and all the electrode contacts and the radio frequency generation module form a loop to distinguish normal tissues from pathological tissues; after the normal tissue and the lesion tissue are distinguished, the electrode contacts in the normal tissue area form passive electric contacts, and the electrode contacts in the lesion tissue area form active electric contacts, so that targeted treatment of the lesion tissue is realized, and side effects generated by electric field treatment are reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to a tumor electric field treatment device, a treatment system and a method for manufacturing the treatment device. Background Art

[0002] At present, the treatment of malignant tumors is only to remove the hyperplastic part through surgery, radiotherapy, etc., which does not effectively alleviate the patient's condition. Tumor Therapeutic Fields (TTF) equipment can inhibit the proliferation of malignant tumors to a certain extent by applying an alternating electric field to the tumor site, greatly increasing the survival time of patients, and providing a new way to treat malignant tumors.

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

[0004] Although the existing tumor therapeutic field (TTF) has brought certain positive effects on the treatment of tumors, TTF suppresses malignant tumors by attaching large electrodes to the scalp to apply electric fields to the entire head. It does not apply targeted, small-scale electric field treatment to the diseased area. When the human body is in the electric field for a long time, it may cause a series of side effects, such as contact dermatitis, neurological system dysfunction, etc. Summary of the invention

[0005] The purpose of the present invention is to overcome the above-mentioned technical deficiencies, propose a tumor electric field treatment device, a treatment system and a method for manufacturing the treatment device, and solve the technical problem in the prior art that tumor electric field treatment is difficult to carry out targeted treatment of the lesion area.

[0006] In order to achieve the above technical objectives, the present invention adopts the following technical solutions: In a first aspect, the present invention provides a tumor electric field treatment device, comprising: Scaffolds, which are implanted in the tumor resection site; and The pole piece module is attached to the frame, and the pole piece module is provided with a plurality of electrode contacts. Each of the electrode contacts forms an active contact or a passive contact by being connected or disconnected with the radio frequency generating module. The active electrical contact is used to form a loop with the radio frequency generating module and form an electric current at the tumor resection site.

[0007] In some embodiments, the frame is an expandable or contractible capsule structure, and the frame can be implanted into the tumor resection site through the contraction of the capsule structure. The electrode module is a flexible electrode, and the electrode module can be attached to the tumor resection site through the expansion of the capsule structure.

[0008] In some embodiments, the frame includes a plurality of elastic bodies, each of which is connected in sequence and enclosed to form the capsule structure. The frame can expand or contract the capsule structure through the deformation of each of the elastic bodies.

[0009] In some embodiments, a liquid accumulation cavity is formed on the inner side of the frame, and a liquid passing gap is formed between each of the elastic bodies, and the liquid passing gap is communicated with the liquid accumulation cavity.

[0010] In some embodiments, the electrode module includes a plurality of flexible electrodes connected in sequence, each of the flexible electrodes is respectively attached to each of the elastic bodies, and each of the electrode contacts is respectively disposed on each of the flexible electrodes.

[0011] In a second aspect, the present invention further provides a tumor electric field treatment system, comprising: The tumor electric field treatment device; A circuit board connected to the pole piece module; An electric field generating module, disposed on the circuit board, for supplying power to the pole piece module so that the pole piece module forms an electric field through each electrode contact; The radio frequency generating module is arranged on the circuit board and is used to energize the electrode module so as to form a current between the electrode contacts forming active electrical contacts.

[0012] In some embodiments, the circuit board is provided with a CMOS semiconductor, and the CMOS semiconductor is connected to the connection part through a microstrip line.

[0013] In some embodiments, the tumor electric field treatment system further comprises a fluid extraction microfluidic tube, which is fixed to the frame and extends to the fluid effusion cavity, and is used to extract cerebral fluid from the fluid effusion cavity.

[0014] In some embodiments, the tumor electric field treatment system further includes a drug delivery microfluidic tube, which is fixed to the frame and extends to the lesion area for delivering drugs to the lesion area.

[0015] In a third aspect, the present invention further provides a method for manufacturing a tumor electric field treatment device, comprising the following steps: S100: forming the frame based on machining; S200: forming the pole piece module based on MEMS technology; S300: Apply glue to the frame; S400: Pasting the electrode module to the frame; S500: releasing the frame from the mold.

[0016] Compared with the prior art, the tumor electric field treatment device provided by the present invention is provided with a frame and a pole piece module. The frame forms the skeleton structure of the treatment device, realizes implantation into the tumor resection site, and provides support for the treatment device. The pole piece module is attached to the frame. The pole piece module is provided with a plurality of electrode contacts, and each electrode contact can form an active electric contact or a passive electric contact. The active electric contact can form a loop with the radio frequency generating module. When the treatment device is implanted into the tumor resection site, all electrode contacts form active electric contacts, and each electrode contact forms a loop with the electric field generating module. Under the power supply of the electric field generating module, an electric field is continuously provided to the tumor resection site to inhibit the growth of cancer cells in the tumor resection site. Since the impedance value of cancer cells in tumor tissue is usually greater than the positive impedance value, the positive impedance value of cancer cells in tumor tissue is generally greater than the positive impedance value. The impedance value of normal tissue cells makes the current value formed between the active electrical contacts in the diseased tissue area relatively small, so that normal tissue and diseased tissue can be distinguished; after distinguishing normal tissue and diseased tissue, the electrode contacts in the normal tissue area form passive electrical contacts, and the electrode contacts in the diseased tissue area form active electrical contacts, and an alternating-frequency current can be separately formed in the diseased tissue area, so that targeted alternating-frequency current treatment can be carried out on the diseased tissue, and cancer cells in the diseased tissue area can be ablated. The tumor electric field treatment system energizes the diseased tissue area separately through the radio frequency generation module, realizes targeted alternating-frequency current treatment on the diseased tissue, and then can carry out targeted ablation of cancer cells in the diseased tissue, thereby reducing the side effects of electric field treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 is a schematic structural diagram of a tumor electric field treatment device provided by an embodiment of the present invention; Figure 2 is a schematic structural diagram of a frame of a tumor electric field treatment device provided by an embodiment of the present invention; Figure 3 is a schematic structural diagram of an electrode module of a tumor electric field treatment device provided by an embodiment of the present invention; Figure 4 is a schematic structural diagram of an electrode module of a tumor electric field treatment device provided by another embodiment of the present invention; Figure 5 is a distribution diagram of electrode contacts of a flexible electrode of a tumor electric field treatment device provided by an embodiment of the present invention; Figure 6 is a diagram of electrode contacts of a flexible electrode of a tumor electric field treatment device provided by another embodiment of the present invention; Figure 7 is a schematic diagram of step (a) of a forming process of an electrode module of a tumor electric field treatment device provided by an embodiment of the present invention; Figure 8 is a schematic diagram of step (b) of the forming process of the electrode module of the tumor electric field treatment device provided by an embodiment of the present invention; Fig. 9 is a schematic diagram of step (c) of the forming process of the electrode module of the tumor electric field treatment device provided by an embodiment of the present invention; Fig.10 is a schematic diagram of step (d) of the forming process of the electrode module of the tumor electric field treatment device provided by an embodiment of the present invention; Fig.11 is a schematic diagram of step (e) of the forming process of the electrode module of the tumor electric field treatment device provided by an embodiment of the present invention; Fig.12 is a schematic diagram of step (f) of the forming process of the electrode module of the tumor electric field treatment device provided by an embodiment of the present invention; Fig.13 is a schematic diagram of step (g) of the forming process of the electrode module of the tumor electric field treatment device provided by an embodiment of the present invention; Fig.14 is a schematic structural diagram of a tumor electric field treatment system provided by an embodiment of the present invention; Fig.15 It is a flow chart of a method for manufacturing a tumor electric field treatment device provided in an embodiment of the present invention. DETAILED DESCRIPTION

[0018] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0019] Existing tumor electric field therapy (TTF) suppresses malignant tumors by applying an electric field to the entire head by attaching large electrodes to the scalp, but does not apply targeted, small-scale electric field therapy to the diseased area, which makes it easy for tumor electric field therapy to cause a series of side effects. In order to solve the technical problem that it is difficult to perform targeted treatment on the diseased area in the existing tumor electric field therapy, an embodiment of the present invention provides a tumor electric field therapy device, which can perform targeted electric field therapy on the diseased tumor tissue area, thereby reducing the side effects of tumor electric field therapy.

[0020] It should be noted that the tumor electric field therapy device described in the present invention is used for but not limited to the treatment of brain tumor tissue. For the convenience of explanation, in the present invention, only the application of the tumor electric field therapy device to the treatment of brain tumor tissue is used as an example for explanation. The principle of applying the tumor electric field therapy device to other types of equipment is essentially the same as the principle applied to the treatment of brain tumor tissue, and will not be repeated here.

[0021] The tumor electric field treatment device provided by the embodiment of the present invention is as follows: Figure 1 As shown, it includes a frame 10 and a pole piece module 20, the frame 10 is used to be implanted in the tumor resection site; the pole piece module 20 is attached to the frame 10, and the pole piece module 20 is provided with a plurality of electrode contacts 21, each electrode contact 21 forms an active contact 211 or a passive contact 212 by being connected or disconnected with a radio frequency generating module, and the active electrical contact 211 is used to form a loop with the radio frequency generating module to form an electric current at the tumor resection site.

[0022] Specifically, the tumor electric field treatment device is provided with a frame 10 and a pole piece module 20. The frame 10 forms the skeleton structure of the treatment device, realizes implantation into the tumor resection site, and provides support for the treatment device. The pole piece module 20 is attached to the frame 10. The pole piece module 20 is provided with a plurality of electrode contacts 21, and each electrode contact 21 can form an active electric contact 211 or a passive electric contact 212. The active electric contact 211 can form a loop with the radio frequency generating module. When the treatment device is implanted into the tumor resection site, each electrode contact 21 is connected to the radio frequency generating module, and an electric field is continuously formed under the power supply of the electric field generating module to inhibit the growth of cancer cells in the tumor resection site. Since the impedance value of cancer cells in tumor tissue is usually greater than the impedance value of normal tissue cells, the current value formed between the active electric contacts 211 in the diseased tissue area 10a is relatively small, such as Figure 5-6 As shown, the normal tissue area and the diseased tissue area 10a can be distinguished; after the normal tissue area and the diseased tissue area 10a are distinguished, the electrode contact 21 in the normal tissue area forms a passive electrical contact 212, as shown in FIG. Figure 5-6 As shown, the electrode contact 21 of the diseased tissue area 10a forms an active electrical contact 211. The active electrical contact 211 of the diseased tissue area 10a can form an alternating current through a loop formed with the radio frequency generating module, while the passive electrical contact 212 of the normal tissue area does not form a current or forms a low-voltage current according to the needs of the disease. Thus, an alternating current is separately introduced into the diseased tissue area 10a, so that the diseased tumor tissue cells can be ablated, thereby achieving targeted treatment of the diseased tumor tissue, effectively reducing the side effects of the electric field therapy, and reducing the damage caused by the electric field therapy to the human body.

[0023] In this embodiment, Figure 5-6 As shown, the active electrical contact 211 includes a positive electrical contact and a negative electrical contact. The positive electrical contact is connected to the output terminal of the RF generating module to receive the RF current, and the negative electrical contact is connected to the ground terminal of the RF generating module to form a loop with the positive electrical contact to form a high-intensity alternating current.

[0024] When conducting targeted treatment of the diseased tissue area 10a, for the proliferative diseased tumor tissue, the RF generating module adjusts the RF signal amplitude, phase, current and power according to the size, shape, and distance between the positive and negative electrical contacts of the lesion area, so that the diseased tissue moves and oscillates at a high speed at the same rate as the RF current frequency to generate friction heat, thereby heating up the inside of the tumor tissue and ablating the diseased tissue in the proliferative area.

[0025] For tissue without hyperplasia, according to the needs of the disease, the active electrical contact 211 located in the center can be made into a negative electrical contact for grounding, and the other active electrical contacts 211 around it can be made into positive electrical contacts for connecting to the positive electricity of the electric field generating module, thereby forming an electric field with an electric field strength of 1-3V / cm and an alternating frequency of 100K-300KHz to interfere with the mitosis process of cancer cells, thereby achieving the effect of inhibiting the proliferation of tumor cells at the lesion site and inducing the death of cancer cells.

[0026] It can be understood that the frame 10 can be any structure such as a plate, a rod, etc. that can be implanted in the tumor resection site and for the electrode module to be attached.

[0027] It is understandable that the pole piece module 20 can be a pole piece structure of any material and shape, as long as it can be attached to the surface of the frame 10 .

[0028] In one embodiment, Figure 1-2 As shown in 14, the frame 10 is an expandable or contractible capsule structure, and the frame 10 can be implanted into the tumor resection site through the contraction of the capsule structure. The electrode module 20 is a flexible electrode 22, and the electrode module 20 can be attached to the tumor resection site through the expansion of the capsule structure.

[0029] Specifically, by setting the frame 10 as an expandable or contractible capsule structure, when the treatment device is implanted, the frame 10 contracts to form a strip structure, thereby reducing the volume, facilitating the implantation of the treatment device, and reducing the implantation trauma. After the treatment device is implanted, it can be expanded according to the size of the tumor resection site, so that each electrode contact 21 can be well fitted with the tissue site. During the tissue recovery process, the frame 10 can be squeezed to shrink the frame 10 and reduce its volume, thereby avoiding hindering the growth and recovery of the tissue. By setting the pole piece module 20 as a flexible electrode 22, it can adapt well to the expansion and contraction of the frame 10, so that the pole piece module 20 can maintain a stable fit with the frame 10 during the expansion and contraction of the frame 10, so that when the frame 10 expands and contracts, the electrode contacts 21 of the lesion site on the pole piece module 20 can also always be above the lesion site, thereby avoiding the expansion and contraction of the frame 10 affecting the treatment of the lesion area.

[0030] It can be understood that the frame 10 can be a closed air bag or liquid bag structure, which can be expanded by inflating air or filling liquid into the frame 10, and can be contracted by exhausting air or draining liquid.

[0031] In one embodiment, Figure 1-2 As shown in FIG. 14 , the frame 10 includes a plurality of elastic bodies 11 , and the elastic bodies 11 are sequentially connected and enclosed to form the capsule structure. The frame 10 can expand or contract the capsule structure through the deformation of the elastic bodies 11 .

[0032] Specifically, the frame 10 expands or contracts through the elastic action of each elastic body 11 itself, and can then expand and contract adaptively according to the size of the tumor resection site, thereby adaptively adjusting the fit between the electrode module 20 and the tissue site, facilitating the growth of the tissue and the acquisition of the lesion area. And through the elastic expansion and contraction of the frame 10 itself, it is possible to expand and contract without forming a closed capsule structure, and it is easy for the frame 10 to form a non-sealed capsule structure. By forming a non-sealed capsule structure, the body fluid between the tissues can pass through the frame 10, and thus will not hinder the flow and exchange of body fluid between the tissues.

[0033] In this embodiment, the frame 10 expands or contracts through the deformation of the middle part of each elastic body 11, and can form a strip structure through extreme contraction, and can form a spherical capsule structure through extreme expansion.

[0034] It can be understood that the elastomer 11 may include but is not limited to elastic materials with biocompatibility such as nickel-titanium alloy, cobalt alloy, and magnesium alloy.

[0035] In one embodiment, Figure 1-2 As shown in Figures 14 and 15, a fluid cavity 12 is formed on the inner side of the frame 10, and a fluid gap 13 is formed between each elastic body 11, and the fluid gap 13 is connected with the fluid cavity 12. Specifically, by forming the fluid cavity 12 on the inner side of the frame 10 and the fluid gap 13 between each elastic body 11, the cerebrospinal fluid formed by the diseased tissue can enter the fluid cavity 12 through the fluid gap 13, thereby facilitating the discharge from the brain and accelerating the treatment of the effusion in the diseased area.

[0036] 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 gap 13 through the obstruction of the tissue part.

[0037] In one embodiment, in order to adapt to the deformation of each elastic body 11, as Figure 1 , 3-4 and 14, the electrode module 20 includes a plurality of sequentially connected flexible electrodes 22, each flexible electrode 22 is attached to each elastic body 11, and each electrode contact 21 is disposed on each flexible electrode 22. Specifically, during the deformation of each elastic body 11, each attached flexible electrode 22 will be driven to deform synchronously. It can be understood that the number of flexible electrodes 22 matches the number of elastomers 11, and their size can be adaptively set according 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, and each electrode contact 21 is arranged in an array and distributed at both ends of the flexible electrode 22 to achieve functions such as accurate collection and ablation of the lesion area.

[0038] It can be understood that the active electrical contact 211 and the passive electrical contact 212 of each electrode contact 21 can be formed through surgery or a contact control module, the positive electrical contact of the active electrical contact 211 is formed by connecting to the output terminal of the radio frequency generating module, and the negative electrical contact of the active electrical contact 211 is formed by connecting to the ground terminal of the radio frequency generating module.

[0039] In one embodiment, Figure 1 , 3 As shown in Figures 4 and 14, the electrode module 20 is further provided with a connecting portion 23, which connects each flexible electrode 22. Specifically, the connecting portion 23 can realize the series connection of each flexible electrode 22, so that the circuit board only needs to be connected to the connecting portion 23, which facilitates the connection between each flexible electrode 22 and the circuit board.

[0040] In this embodiment, the connection portion 23 is provided with a microstrip line, and the microstrip line is reversely soldered to a CMOS (complementary metal oxide semiconductor) to achieve control of the high-channel electrode and signal collection.

[0041] like Figure 1 and 3 -4, in this embodiment, the connecting portion 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.

[0042] An embodiment of the present invention also provides a tumor electric field treatment system, including a circuit board 30, a radio frequency generating module, a radio frequency generating module and the tumor electric field treatment device, wherein the circuit board 30 is connected to the electrode module 20 of the tumor electric field treatment device; the radio frequency generating module is arranged 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, and the radio frequency generating module is arranged 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 that forms an active electrical contact 211.

[0043] Specifically, when the treatment device is implanted in the tumor resection site, all electrode contacts 21 form active electrical contacts 211, and each electrode contact 21 forms a loop with the radio frequency generation module. The radio frequency generation module supplies power to each electrode contact 21, so that an electric field is formed between each electrode contact 21. Since the impedance value of cancer cells in tumor tissue is usually greater than the impedance value of normal tissue cells, the current value formed between the active electrical contacts 211 in the diseased tissue area 10a is relatively small, so that normal tissue and diseased tissue can be distinguished; normal tissue and diseased tissue can be distinguished. After tissue treatment, the electrode contacts 21 in the normal tissue area form passive electrical contacts 212, and the electrode contacts 21 in the diseased tissue area 10a form active electrical contacts 211. The active electrical contacts 211 in the diseased tissue area 10a can form current through the loop formed with the radio frequency generating module, while the passive electrical contacts 212 in the normal tissue area cannot form current, thereby achieving separate electrification of the diseased tissue area 10a, achieving targeted treatment of the diseased tumor tissue, effectively reducing the side effects of electric field therapy, and reducing the damage caused to the human body by electric field therapy.

[0044] In this embodiment, the circuit board 30 is also provided with a charging circuit, a data processing circuit, a wireless communication circuit, a power management circuit, a pulse generating circuit, an inverted solder contact array, etc. The data processing module in the PCB circuit processes the electrode acquisition signal transmitted by the microstrip line 32, and the wireless communication module is used to realize the real-time, fast and accurate extraction of the neural signal to minimize the transmission loss and noise signal. The power management circuit can control the on and off of each module according to the working mode, and the pulse generating circuit realizes the application of high-frequency pulse signals to the implanted electrode module to realize the inhibition and ablation function of the tumor.

[0045] In this embodiment, a contact control module is further disposed on the circuit board 30 , and the contact control module is used to control each electrode contact 21 to form an active electrical contact 211 or a passive electrical contact 212 .

[0046] In one embodiment, the circuit board 30 is provided with a CMOS semiconductor 31, and the CMOS semiconductor 31 is connected to the connection part 23 via a microstrip line 32. Specifically, the electrode module can realize the control and signal collection of the high-channel electrode module by connecting the CMOS semiconductor 31.

[0047] In this embodiment, the CMOS semiconductor 31 is fixed to the flip-chip contact array of the circuit board 30 by a flip-chip bonding process.

[0048] In this embodiment, the tumor electric field therapy system further 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 .

[0049] In one embodiment, the tumor electric field treatment system further includes a fluid extraction microfluidic tube 50, which is fixed to the frame 10 and extends to the fluid collection cavity 12, and is used to extract cerebrospinal fluid from the fluid collection cavity 12. Specifically, the fluid extraction microfluidic tube 50 can prevent the increase of intracranial pressure caused by cerebrospinal fluid after tumor surgery by extracting cerebrospinal fluid from the fluid collection cavity 12, and reduce the complications caused by the increase of intracranial pressure after tumor surgery.

[0050] In one embodiment, the tumor electric field treatment system further includes a drug delivery microfluidic tube 60, which is fixed to the frame 10 and extends to the lesion area for delivering drugs to the lesion area. Specifically, the drug delivery microfluidic tube 60 can achieve precise drug delivery to the lesion area, and by precisely delivering drugs to the lesion area, the side effects caused by taking chemotherapy drugs can be reduced.

[0051] In one embodiment, the tumor electric field treatment system also includes a pumping device 70, which connects the liquid extraction microfluidic and drug delivery microfluidic tubes 60 to achieve the extraction of cerebrospinal fluid and the drug delivery to the lesion area.

[0052] The present invention also provides a method for manufacturing a tumor electric field treatment device. Fig.15 As shown, the following steps are included: S100: forming the frame based on machining; S200: forming the pole piece module based on MEMS technology; S300: Apply glue to the frame; S400: Pasting the electrode module to the frame; S500: releasing the frame from the mold.

[0053] Specifically, through the above process steps, a treatment device can be formed that can achieve targeted treatment of tumor tissue areas, effectively reducing the damage caused by electric field therapy to the human body.

[0054] In this embodiment, in the step of processing to form the frame 10, the frame 10 can be prepared by a tube body with a diameter of 0.5 cm, 1 cm, 2 cm, 3 cm, 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 by a laser cutting process to form a semi-finished frame 10 of a balloon structure. The semi-finished frame 10 is then post-processed, and the post-processing includes but is not limited to heat treatment, pickling, sandblasting, polishing and other processes 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.

[0055] In this embodiment, the electrode module 20 and the microstrip line are used to prepare high-channel electrodes on the PI flexible electrode 22 based on the MEMS (micro-electromechanical system) process, so as to realize the detection, electric field suppression and ablation functions of the treatment device. The specific MEMS process flow of the electrode module is as follows: (a) If Figure 7 As shown, a substrate 301 is prepared, and the substrate material includes but is not limited to: silicon wafer, quartz wafer, silicon carbide, etc. An oxide layer 302 is prepared on the surface of the silicon wafer as a dielectric layer; (b) If Figure 8 As shown, a first layer of flexible base material 303 is prepared on the surface of the wafer substrate 301. The base material 303 may include but is not limited to PI, PDMS, silicone resin, etc. The base material 303 is subjected to the steps of coating, photolithography, and development to prepare the base shape of the electrode module; (c) If Fig. 9 As shown, metal is deposited on the surface of the substrate material 303 to prepare metal electrodes and metal wiring 304. 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.

[0056] (d) If Fig.10 As shown, a metal electrode surface modification material 305 is deposited and the deposited modification material 305 is patterned. The modification material 305 includes but is not limited to one or more of platinum, titanium nitride, iridium oxide, etc.

[0057] (e) If Fig.11 As shown, an insulating layer 306 is spin-coated, and the insulating layer 306 may include but is not limited to PI, PDMS, silicone resin, etc., and the insulating layer is coated, photolithographically processed, and developed, and a cavity is prepared by RIE etching.

[0058] (f) If Fig.12 As shown, indium metal is deposited, and the metal surface is coated, photolithographically processed, and developed. The indium metal is patterned using a dry etching method to form a CMOS flip-flop array 307.

[0059] (g) If Fig.13 As shown, the base material 303 is released from the substrate 301 . The release process can be performed by any one or a combination of mechanical, physical or chemical methods to complete the preparation of the flexible electrode module 20 .

[0060] Through the above preparation process, the number of electrodes that can be electrically contacted can be guaranteed while the flexible electrode module 20 is prepared.

[0061] In this embodiment, before the step of pasting the electrode module to the frame, the finished frame 10 is flattened on a mold.

[0062] In this embodiment, in the step of pasting the electrode module 20, a biocompatible glue is evenly applied on the frame 10, and the prepared flexible electrode module 20 is pasted to the frame 10 and cured. The biocompatible glue may include but is not limited to UV curing glue, 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.

[0063] In this embodiment, after the tumor electric field therapy device is formed, the indium column solder joints of the wires of the flexible electrode 22 are soldered to the CMOS using a flip-chip soldering process, and then the liquid extraction microfluidic tube 50 and the drug delivery microfluidic tube 60 are fixed to the frame 10, thereby forming the tumor electric field therapy system of this embodiment.

[0064] In order to better understand the present invention, the following Figure 1-6 14 and 15 describe the technical scheme of the present invention in detail: in the process of treating tumor tissue, firstly, the tumor tissue is removed by conventional tumor resection surgery, and the shrunk treatment device is implanted into the tumor resection site through the surgical incision, and the treatment device expands into a balloon shape, so that the electrode module is attached to the tissue after tumor resection. Due to the unlimited reproduction and close arrangement of cancer cells, tumor tissue requires a large amount of free water to promote division, so its impedance value is usually greater than that of normal tissue. The impedance value of the tumor resection site at different frequencies is measured by supplying electricity to each electrode through the electric field generating module, distinguishing normal tissue from diseased tissue, and determining the size, shape and state of the proliferating tumor at the tumor resection site. The electrode contact 21 of the contact control module that controls the diseased tissue is an active electrical contact 211, and the electrode contact 21 that controls the normal tissue is a passive electrical contact 212. The positive electrical contact of the active electrical contact 211 is connected to the output terminal of the RF generating module and receives the RF ablation current of the RF generating module. The negative electrical contact is connected to the ground terminal of the RF generating module to form a loop with the positive electrical contact. The RF generating module device adjusts the RF signal amplitude, phase, current and power according to the size and shape of the lesion area and the distance between the positive electrical contact and the negative electrical contact, so that the diseased tissue moves and oscillates at a high speed at the same rate as the RF current frequency to generate friction heat, thereby heating up the inside of the tumor tissue and ablating the diseased tissue in the hyperplastic area.

[0065] The tumor electric field treatment system also extracts cerebrospinal fluid from the tumor resection site through the set extraction microfluidic tube 50 to prevent the increase of intracranial pressure caused by cerebrospinal fluid after tumor surgery and reduce the complications caused by the increase of intracranial pressure after tumor surgery. At the same time, for the postoperative tissue without hyperplasia, while applying the tumor suppression electric field, the drug delivery microfluidic tube 60 accurately delivers drugs to the postoperative lesion area to reduce the systemic side effects caused by taking chemotherapy drugs.

[0066] The specific implementation of the present invention described above does not constitute a limitation on the protection scope of the present invention. Any other corresponding changes and modifications made based on the technical concept of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. A tumor electric field treatment device, characterized in that: include: The frame is used to be implanted in the tumor resection site; and The pole piece module is attached to the frame, and the pole piece module is provided with a plurality of electrode contacts. Each of the electrode contacts forms an active contact or a passive contact by being connected or disconnected with the radio frequency generating module. The active electrical contact is used to form a loop with the radio frequency generating module and form an electric current at the tumor resection site.

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

3. The tumor electric field treatment device according to claim 2, characterized in that: The frame includes a plurality of elastic bodies, each of which is connected in sequence and enclosed to form the capsule structure. The frame can expand or contract the capsule structure through the deformation of each of the elastic bodies.

4. The tumor electric field treatment device according to claim 3, characterized in that: A liquid accumulation cavity is formed on the inner side of the frame, and a liquid passing gap is formed between the elastic bodies, and the liquid passing gap is communicated with the liquid accumulation cavity.

5. The tumor electric field treatment device according to claim 3, characterized in that: The electrode module includes a plurality of flexible electrodes connected in sequence, each of the flexible electrodes is respectively attached to each of the elastic bodies, and each of the electrode contacts is respectively arranged on each of the flexible electrodes.

6. A tumor electric field treatment system, characterized in that: include: The tumor electric field treatment device according to any one of claims 1 to 5; A circuit board connected to the pole piece module; An electric field generating module, disposed on the circuit board, for supplying power to the pole piece module so that the pole piece module forms an electric field through each electrode contact; The radio frequency generating module is arranged on the circuit board and is used to energize the electrode module so as to form a current between the electrode contacts forming active electrical contacts.

7. The tumor electric field treatment system according to claim 6, characterized in that: The circuit board is provided with a CMOS semiconductor, and the CMOS semiconductor is connected to the connection part through a microstrip line.

8. The tumor electric field treatment system according to claim 6, characterized in that: The tumor electric field treatment system also includes a liquid extraction microfluidic tube, which is fixed to the frame and extends to the fluid accumulation cavity, and is used to extract cerebral fluid in the fluid accumulation cavity.

9. The tumor electric field treatment system according to claim 6, characterized in that: The tumor electric field treatment system also includes a drug delivery microfluidic tube, which is fixed to the frame and extends to the lesion area for delivering drug to the lesion area.

10. A method for manufacturing a tumor electric field treatment device, characterized in that: The following steps are involved: S100: forming the frame based on machining; S200: forming the pole piece module based on MEMS technology; S300: Apply glue to the frame; S400: Pasting the electrode module to the frame; S500: releasing the frame from the mold.

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