Implanted electrode and electric field therapy device for intracranial tumor treatment

Abstract

The application provides an implantable electrode and an electric field treatment device for intracranial tumor treatment. The implantable electrode for intracranial tumor treatment comprises a flexible electrode, the flexible electrode comprises a flexible base layer and at least one electrode unit arranged on the flexible base layer, at least one end of the flexible base layer is not covered by the electrode unit, and an extension section is formed at the part of the flexible base layer not covered by the electrode unit. The electric field treatment device comprises a control module and the implantable electrode, the control module and the flexible electrode of the implantable electrode are electrically connected to generate an alternating electric field. The flexible electrode can be attached to the surface of a tumor cavity by surface adhesion, and the extension section can extend out of the tumor cavity and be attached to the surface of brain tissue, so that the flexible electrode can be stably fixed in the body. Therefore, the targeting of tumor electric field treatment can be obviously improved, the stability of the electric field in the related area can be improved, the compliance of the patient can be improved, adverse reactions can be reduced, and the treatment effect can be improved as a whole.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to implantable electrodes and electric field therapy devices for the treatment of intracranial tumors. Background Technology

[0002] Gliomas are the most common malignant tumors of the brain, a collective term for tumors originating from glial cells and neurons in the nervous system, accounting for 40% to 50% of all intracranial tumors. The median survival for glioblastoma patients is between 14.6 and 17 months, making it a serious malignant disease that severely impacts human health and quality of life. Currently, surgical resection remains the primary treatment for gliomas. However, due to the diffuse growth of these tumors and the lack of a clear boundary between the tumor and normal tissue, complete resection is difficult in practice to preserve normal physiological function. Clinically, it has also been found that these tumors have a high recurrence rate and poor prognosis after surgery. Most importantly, the blood-brain barrier exists within the brain, making it difficult for most drugs to cross this barrier and exert their effects on the tumor.

[0003] Tumor-treating fields (TTFields) therapy uses low-intensity, mid-frequency alternating electric fields to act on the microtubules of proliferating cancer cells, interfering with tumor cell mitosis and thus inhibiting tumor growth and inducing apoptosis in affected cancer cells. Therefore, TTFields therapy has gained widespread attention and recognition among physicians as a novel treatment approach. An international phase III multicenter clinical trial in newly diagnosed glioblastoma patients showed that, compared with temozolomide (TMZ) chemotherapy alone, TTFields therapy combined with TMZ significantly improved progression-free survival (PFS) and overall survival (OS). The study confirmed that the combination of TTFields therapy and temozolomide in the treatment of newly diagnosed glioblastoma increased the five-year overall survival (OS) from 5% to 13%, and extended the median overall survival from 16 months to 20.9 months. The efficacy of TTFields therapy is closely related to adherence; patients with high adherence had significantly prolonged median survival.

[0004] Currently, the key component of tumor electric field therapy devices on the market, the electrode, is externally mounted. The main structure of the externally mounted electrode is as shown in the attached diagram. Figure 1As shown, when a tumor 103 is present in a patient's brain, a common treatment method in the prior art is to attach an external electrode 101 to the patient's scalp 104. Clinical results, physician and patient surveys, and comprehensive analysis have revealed the following shortcomings of the external electrode approach: First, it generates significant heat, which can cause inflammation and allergies on the scalp 104; second, the effect is unstable, as frequent replacement and reattachment of the electrode during treatment means the placement cannot be consistently consistent, leading to variations in the electric field applied to the tumor area; third, patient compliance is poor, as shaving the hair and scalp inflammation or allergies during use reduce the time patients spend wearing the device. Since treatment effectiveness is directly and positively correlated with wearing time, reducing wearing time negatively impacts treatment outcomes.

[0005] To address these issues, current technologies focus on implanting electrodes into intracranial tumor sites. However, existing implantable electrodes, after being inserted into the tumor resection cavity, are often led out using sutures, which are then fixed to the brain tissue or skull outside the tumor cavity using screws, adhesives, or sutures. This suture fixation method can easily lead to instability in the electrode's position within the tumor resection cavity, thus affecting the effectiveness of electric field therapy. Adhesive fixation presents biocompatibility issues, posing a risk of chronic adverse reactions such as inflammation and allergies. Furthermore, the use of screws and sutures often further increases the risk of intracranial injury. Summary of the Invention

[0006] The present invention is made in view of the defects and shortcomings of the prior art. The object of the present invention is to provide an implantable electrode for the treatment of intracranial tumors, comprising: a flexible electrode, the flexible electrode including a flexible base layer and at least one electrode unit disposed on the flexible base layer; at least one end of the flexible base layer is not covered by the electrode unit, and the portion of the flexible base layer not covered by the electrode unit has an extension segment.

[0007] In at least one embodiment, the electrode unit of the flexible electrode is used to be placed within the tumor cavity formed after tumor resection, and the extension of the flexible electrode is used to be attached to the surface of brain tissue outside the tumor cavity.

[0008] In at least one embodiment, in the length direction of the flexible substrate, the flexible electrode includes at least two electrode units spaced apart on the flexible substrate; the two electrode units are located at the non-ends of the flexible substrate.

[0009] In at least one embodiment, the flexible electrode is bent into a Z-shape in the implanted state, wherein at least two electrode units are located in the tumor cavity and are arranged opposite each other at intervals, and the two electrode units are arranged to generate an alternating electric field; the two ends of the flexible base layer itself are extension segments, and the two extension segments of the flexible base layer are used to extend out of the tumor cavity in opposite directions and attach to the surface of the brain tissue outside the tumor cavity.

[0010] In at least one embodiment, the electrode unit includes a flexible substrate layer, a conductive layer, and an encapsulation layer covering the flexible substrate layer and the conductive layer, which are sequentially stacked on the flexible substrate layer. The flexible substrate layer and the encapsulation layer are made of a biocompatible material.

[0011] In at least one embodiment, the flexible substrate layer is made of at least one of polydimethylsiloxane, polyethylene terephthalate, polyimide, or polyethylene; the flexible substrate layer is made of at least one of thermoplastic polyurethane or medical-grade silicone; the conductive layer is made of at least one of carbon nanotubes, graphene, polythiophene, polyaniline, polypyrrole, conductive hydrogel, gold, silver, or platinum-iridium alloy; and the encapsulation layer is made of at least one of polydimethylsiloxane, polyethylene terephthalate, polyimide, and composite high-dielectric-constant materials containing inorganic nanoparticles as fillers. The inorganic nanoparticles may be selected from titanium dioxide, ferroelectric nanoparticles, barium titanate (BaTiO3), etc. In application, the flexible substrate layer and flexible substrate layer exhibit good deformability, bending without breakage, and can adapt to common deformation types such as bending, shaping, uniaxial tension, biaxial tension, and radial tension.

[0012] In at least one embodiment, the conductive layer of the flexible electrode is rectangular in shape, or includes a long strip-shaped main trunk and several spaced branches, wherein the several spaced branches are integrally connected to one side of the same main trunk.

[0013] In at least one embodiment, the extension of the flexible electrode includes a plurality of through holes penetrating the flexible substrate.

[0014] The electric field therapy device included in the embodiments of the present invention includes: a control module; and an implantable electrode for treating intracranial tumors as described above, wherein the implantable electrode for treating intracranial tumors is electrically connected to the control module and is used to generate an alternating electric field; the implantable electrode for treating intracranial tumors is at least two, or the implantable electrode for treating intracranial tumors includes at least two electrode units.

[0015] In at least one embodiment, the flexible electrode is a first electrode, the control module is electrically connected to the flexible electrode, the electrode unit of the flexible electrode is used to be placed within the tumor cavity formed after tumor resection, and the extension section of the flexible electrode is used to extend out of the tumor cavity and attach to the surface of brain tissue outside the tumor cavity; the electric field therapy device further includes at least one second electrode, which is also electrically connected to the control module and is used to be disposed outside the tumor cavity, the control module being configured to generate an alternating electric field between the flexible electrode and at least one second electrode. Preferably, the second electrode is used for implantation in a position below the skull and above the dura mater.

[0016] In at least one embodiment, the electric field therapy device has two modes: an electric field therapy mode and an impedance measurement mode. Preferably, in the electric field therapy mode, the control module supplies alternating current of a certain frequency to the flexible electrode or to the flexible electrode and the second electrode to apply an electric field to the tumor cells in the target area; and / or, in the impedance measurement mode, the control module supplies alternating current of a certain frequency range to the flexible electrode or to the flexible electrode and the second electrode to measure the impedance value of the target area.

[0017] Compared with the prior art, the present invention has the following beneficial technical effects:

[0018] (1) Compared with existing external electrodes, the implantable electrode for intracranial tumor treatment of the present invention can be directly implanted into the tumor cavity after tumor resection, with more precise targeting and can directly apply the best treatment intensity to the nearby residual tumor area; moreover, there are few adverse reactions, no obvious fever, and it is not easy to cause scalp inflammation or allergies; and it avoids the obstruction of high-resistance tissues such as skull and scalp, and can produce considerable treatment effect based on low energy input.

[0019] (2) Compared to existing implantable electrodes, the implantable electrode for intracranial tumor treatment of the present invention can directly adhere to the surface of the tumor cavity after implantation by relying on the surface adhesion force of the flexible electrode. Further fixation is achieved by forming an extension segment in the flexible base layer, extending beyond the tumor cavity and attaching to the surface of the brain tissue. The flexible electrode of the present invention maintains a stable position within the tumor cavity, thereby ensuring a stable electric field applied to the target area without significant fluctuations. Furthermore, the implantation method is simple and less prone to causing intracranial damage. The flexible electrode can also adapt to changes in brain tissue displacement, allowing it to operate intracranially for extended periods, resulting in higher patient compliance and thus better treatment outcomes.

[0020] (3) The electric field therapy device of the present invention includes a first electrode implanted in the tumor cavity and a second electrode implanted outside the tumor cavity, which makes the targeting of tumor electric field therapy more precise, and the electric field can cover a larger area of ​​residual tumor, reducing the treatment blind zone of the electric field effect, thereby better preventing tumor recurrence. Moreover, both the first electrode and the second electrode can be well fixed in the body, and do not need to be frequently replaced during the treatment process like external electrodes. Their relative positions are more stable and the treatment effect is more stable.

[0021] (4) The electric field therapy device of the present invention has a closed-loop control function. The electrode can not only apply an electric field but also measure the impedance value of the tissue, sense the growth of the tumor in real time, and then adjust the application parameters of the electric field to find the best treatment parameters suitable for each patient and improve the treatment effect. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This is a schematic diagram illustrating the usage state of one embodiment of the prior art;

[0024] Figure 2 This is a schematic diagram of the usage state of one embodiment of the electric field therapy device of the present invention;

[0025] Figure 3 This is a perspective view of a planar unfolded state of one embodiment of the flexible electrode in this invention;

[0026] Figure 4 This is a schematic diagram of a composite structure of an embodiment of the electrode unit of the flexible electrode of the present invention;

[0027] Figure 5 This is a shape outline diagram of the conductive layer of the electrode unit of the flexible electrode in this invention.

[0028] Figure 5 (a) is a shape outline diagram of the conductive layer of the electrode unit of the flexible electrode in the present invention in the first embodiment.

[0029] Figure 5 (b) is a shape outline diagram of the conductive layer of the electrode unit of the flexible electrode in the second embodiment of the present invention.

[0030] Figure 5 (c) is a shape outline diagram of the conductive layer of the electrode unit of the flexible electrode in the third embodiment of the present invention.

[0031] Figure 5 (d) is a shape outline diagram of the conductive layer of the electrode unit of the flexible electrode in the fourth embodiment of the present invention.

[0032] Figure 5 (e) is a shape outline diagram of the conductive layer of the electrode unit of the flexible electrode in the fifth embodiment of the present invention.

[0033] Figure 5 (f) is a shape outline diagram of the conductive layer of the electrode unit of the flexible electrode in the sixth embodiment of the present invention.

[0034] Figure 6 This is a schematic diagram of the usage state of one embodiment of the electric field therapy device of the present invention;

[0035] Figure 7 This is a shape outline diagram of the conductive layer of the second electrode in this invention;

[0036] Figure 7 (a) is a shape outline diagram of the conductive layer of the second electrode in the first embodiment of the present invention;

[0037] Figure 7 (b) is a shape outline diagram of the conductive layer of the second electrode in the second embodiment of the present invention;

[0038] Figure 7 (c) is a shape outline diagram of the conductive layer of the second electrode in the third embodiment of the present invention;

[0039] Figure 7 (d) is a shape outline diagram of the conductive layer of the second electrode in the fourth embodiment of the present invention;

[0040] Figure 7 (e) is a shape outline diagram of the conductive layer of the second electrode in the fifth embodiment of the present invention.

[0041] Explanation of reference numerals in the attached figures

[0042] 101-Attached electrode; 102-Brain tissue; 103-Tumor; 104-Scalp; 105-Skull; 20-Flexible electrode; 21-Flexible substrate layer; 211-Extension segment; 212-Through hole; 22-Electrode unit; 221-Flexible substrate layer; 222-First conductive layer; 2221-Main trunk; 2222-Branch; 2223-Conductive sheet; 223-Encapsulation layer; 23-Flexible wire; 30-Second electrode; 322-Second conductive layer; 3221-Fixing hole; 3222-Radial strip; 3223-Circular strip; 3224-Swirl strip; R-Tumor cavity. Detailed Implementation

[0043] The present invention will be further described in detail below with reference to specific embodiments:

[0044] Example 1

[0045] Please see Figures 2 to 6 This embodiment provides an electric field therapy device, including a control module (not shown) and an implantable electrode for treating intracranial tumors. The implantable electrode for treating intracranial tumors is electrically connected to the control module to generate an alternating electric field. The implantable electrode for treating intracranial tumors includes a flexible electrode 20, which includes a flexible base layer 21, at least one electrode unit 22 disposed on the flexible base layer, and a flexible wire 23. The electrode unit 22 is used to be placed within the tumor cavity R formed after tumor resection. After implantation into the tumor cavity R, the flexible electrode 20 can be directly attached to the surface of the tumor cavity R by surface adhesion. At least one end of the flexible base layer 21 is not covered by the electrode unit 22. The portion of the flexible base layer 21 not covered by the electrode unit 22 forms an extension 211. The extension 211 extends out of the tumor cavity R and attaches to the surface of the brain tissue 102, which can further fix the flexible electrode 20 and make it more stable. Furthermore, the flexible electrode 20 of the present invention is very soft and can adapt to the displacement of the brain tissue 102, reducing patient discomfort and minimizing the risk of intracranial tissue damage. The flexible wire 23 is partially embedded in the flexible substrate 21, and one end of the flexible wire 23 is electrically connected to the electrode unit 22, while the other end extends out of the flexible substrate 21 to be electrically connected to the external control module.

[0046] The flexible electrode 20 has an extremely thin sheet-like structure, which can be square, rectangular, elongated, or other irregular shapes. The elongated shape may also include parts of a rectangle. An elongated shape mainly refers to a shape with a large length-to-width ratio and parallel edges. The flexible electrode 20 is preferably elongated, allowing it to bend and extend into the tumor cavity R more easily and to better conform to the wall of the tumor cavity R. The flexible electrode 20 of this invention has a thickness of 50 μm to 1 mm, a length of 8 to 25 mm, and an extension segment 211 extending outward from the tumor cavity R with a length of 2 to 5 mm to increase the reliability of fixation. In practical applications, the electrode can also be configured according to the size and shape of the tumor cavity R after tumor resection.

[0047] In this embodiment, by implanting the flexible electrode 20 into the tumor cavity R rather than attaching it to the scalp 104, the targeting of the electric field therapy can be improved. The optimal treatment intensity can be applied directly to the residual tumor area near the tumor cavity R, with fewer adverse reactions, no significant heating, and less likelihood of inflammation or allergies to the scalp 104. Furthermore, it avoids the obstruction of high-resistance tissues such as the skull 105 and scalp 104, allowing for a considerable therapeutic effect with relatively low energy input. Because the flexible electrode 20 is very thin and has good self-adhesion, it can be directly attached to the surface of the tumor cavity R by relying on surface adhesion. Furthermore, by forming an extension segment 211 on the flexible base layer 21 for attachment to the brain tissue 102 at the outer edge of the tumor cavity R, the relative position of the flexible electrode 20 is fixed, so that the electric field received by the target area is stable and does not change significantly, resulting in better treatment effect. In addition, the flexible electrode 20 can adapt to the displacement of the brain tissue 102, reducing patient discomfort. It can work in the cranium for a long time, resulting in higher patient compliance and thus better treatment effect.

[0048] In one embodiment, two or more flexible electrodes 20 can be simultaneously disposed within the tumor cavity R. Each flexible electrode 20 is generally bent into an L-shape within the tumor cavity R, with a portion of the electrode unit 22 located within the tumor cavity R and an extension 211 located outside the tumor cavity R and attached to the surface of the brain tissue 102. Multiple flexible electrodes 20 can be disposed adjacently or opposite to each other, thereby generating an alternating current electric field around the tumor cavity R's sidewalls between the multiple electrode units 22, acting more efficiently and comprehensively on the tissue surrounding the tumor cavity R, thus better inhibiting tumor 103 recurrence. In another embodiment, each flexible electrode 20 can also have two or more electrode units 22 disposed side-by-side in the width direction, thereby generating an alternating current electric field around the tumor cavity R's sidewalls between every two electrode units 22.

[0049] Please see Figure 3 The extension segment 211 of the flexible electrode 20 may further include multiple through holes 212 penetrating the flexible base layer 21, and the multiple through holes 212 can be arranged arbitrarily. Preferably, the through holes 212 are arranged with a certain distribution density. By providing through holes 212 in the extension segment 211, the adhesion between the extension segment 211 and the brain tissue 102 can be improved. Moreover, after the flexible electrode 20 is implanted into the tumor cavity R, during the treatment process, the brain tissue 102 can migrate and grow on the surface of the extension segment 211 and pass through the through holes 212, which further helps to fix the flexible electrode 20 during the treatment process, thereby improving the stability of electric field therapy.

[0050] See also: Figure 4The electrode unit 22 includes a flexible substrate layer 221, a first conductive layer 222, and an encapsulation layer 223, which are sequentially stacked on the surface of the flexible substrate layer 21. The flexible substrate layer 21 can be made of materials such as polydimethylsiloxane (PDMS), polyethylene terephthalate (PET), polyimide (PI), or polyethylene (PE). The flexible substrate layer 221 has good deformability during application, preventing breakage when bent, which is beneficial for electrodeposition. The flexible substrate layer 221 can be made of materials such as thermoplastic polyurethane (TPU) or medical silicone. The conductive layer 222 must have good conductivity, and its materials can be emerging materials such as carbon nanotubes and graphene, conductive polymers such as polythiophene (PTi), polyaniline (PANI), and polypyrrole (PPy), hydrogel materials, and metallic materials such as gold, silver, and platinum-iridium alloys. The material of the encapsulation layer 223 can be PDMS, PI, PET, etc., or it can be a composite high dielectric constant material containing inorganic nanoparticles as fillers, such as titanium dioxide, ferroelectric nanoparticles, barium titanate (BaTiO3), etc.

[0051] In this embodiment, the shape of the first conductive layer 222 in the flexible electrode 20 can be selected as an example such as... Figure 5 As shown, Figure 5 As shown in (a), the shape of the first conductive layer 222 in the flexible electrode 20 can be a basic rectangle. Alternatively, the shape of the first conductive layer 222 can also be composed of a long strip-shaped main trunk 2221 and multiple long strip-shaped branches 2222, with several spaced branches 2222 integrally connected to one side of the same main trunk 2221; several conductive sheets 2223, larger than the width of the long strip-shaped branches 2222 themselves, are also spaced on the branches 2222. The shape of the conductive sheets 2223 can be circular, rectangular, rhomboid, hexagonal, or a combination of one or more other shapes. Figure 5 As shown in (b), the main trunk 2221 and branches 2222 of the first conductive layer 222 each have a rectangular strip outline. Figure 5 As shown in (c), the conductive sheets 2223 of the first conductive layer 222 all have circular outlines. Figure 5 As shown in (d), the conductive sheets 2223 of the first conductive layer 222 all have rectangular outlines. Figure 5 As shown in (e), the conductive sheets 2223 of the first conductive layer 222 all have a rhomboid outline. Figure 5 As shown in (f), the conductive sheets 2223 of the first conductive layer 222 all have hexagonal outlines. By providing the main trunk 2221, branches 2222 and conductive sheets 2223 in the first conductive layer 222, the electrode unit 22 can generate an electric field of the required intensity and direction, while increasing the flexibility and conformability of the flexible electrode 20, thereby making the adhesion to the surface of the tumor cavity R more firm.

[0052] Example 2

[0053] This embodiment provides an electric field therapy device, whose structure is largely the same as that of Embodiment 1, except that:

[0054] Please see Figure 3 and 6 Along the length of the flexible substrate 21, the flexible electrode 20 includes at least two electrode units 22 spaced apart from each other in the flexible substrate 21. The electrode units 22 are all located at the non-ends of the flexible substrate 21, and an extension segment 211 is formed at each of the opposite ends of the flexible substrate 21.

[0055] After implantation into the tumor cavity R, the flexible electrode 20 can be bent into a roughly "V" shape. Two electrode units 22 are spaced apart and positioned opposite each other to generate an alternating electric field between the two electrode units 22. Two extension segments 211 extend outward from the tumor cavity R in opposite directions and adhere to the surface of the brain tissue 102. The two extension segments 211 and the "V" shaped structure enable the flexible electrode 20 to adhere more firmly to the surface of the tumor cavity R, maintain a more stable position during subsequent treatment, and thus improve the effect of electric field therapy.

[0056] Example 3

[0057] Please see Figure 6 This embodiment provides an electric field therapy device, which includes a control module (not shown) and one or more flexible electrodes 20, wherein the flexible electrodes 20 have a structure that is generally the same as that of Embodiment 1 or Embodiment 2, the difference being:

[0058] The flexible electrode 20 is defined as the first electrode. The electric field therapy device also includes at least one second electrode 30. The second electrode 30 is disposed outside the tumor cavity R and electrically connected to the control module. The control module can be configured to generate an alternating electric field between the flexible electrode 20 and the second electrode 30, thereby expanding the range of electric field direction and improving the electric field therapy effect.

[0059] Specifically, the second electrode 30 can be implanted under the skull 105 and above the dura mater. The overall structure and material composition of the second electrode 30 are substantially the same as those of the flexible electrode 20, and the control module is configured to generate an alternating electric field between the flexible electrode 20 and at least one electrode unit (not shown) of the second electrode 30.

[0060] Understandably, in practical applications, one or more second electrodes 30 can be set in the area surrounding all tumor cavities R, and the direction of the electric field can be changed periodically between the second electrode 30 and the flexible electrode 20 to optimize the electric field treatment effect.

[0061] In this embodiment, the electrode unit of the second electrode 30 has a second conductive layer 322 (not shown), the material of which can be selected to be similar to that of the first conductive layer 222, and the shape can be selected as follows: Figure 7 As shown. Figure 7 (a) to Figure 7 As shown in (e), the conductive layer 322 in the second electrode 30 includes two or more fixing holes 3221, allowing the second electrode 30 to be fixed to the inner surface of the skull 105 via titanium pins. The shape and outline of the second conductive layer 322 can be rectangular, circular, or annular, or as shown in (e). Figure 7 As shown in (d), it comprises several concentric annular bars 3223, which are integrally connected in the shape of radial bars 3222, or as... Figure 7 As shown in (e), the vortex bar 3224 has a shape with fixing holes 3221 spaced apart along the vortex trajectory. Various shapes of the second conductive layer 201 of the second electrode 30 facilitate installation and fixation in practical applications, and generate an electric field of the desired direction and intensity as needed.

[0062] Example 4

[0063] This embodiment provides an electric field therapy device, which has a similar structure to that of Embodiment 3, except that:

[0064] The electric field therapy device has two modes: electric field therapy mode and impedance measurement mode. In electric field therapy mode, the control module supplies alternating current of a certain frequency to the flexible electrode 20 or to the flexible electrode 20 and the second electrode 30 to apply an electric field to the tumor cells in the target area. In impedance measurement mode, the control module supplies alternating current of a certain frequency range to the flexible electrode 20 or to the flexible electrode 20 and the second electrode 30 to measure the impedance value of the target area. The target area may include the entire inner cavity and sidewalls of the tumor cavity R.

[0065] Because tumor tissue typically has a lower impedance value than normal tissue, its growth can be monitored in real time by measuring the impedance value. In this embodiment, the electric field therapy device has two modes: an electric field therapy mode and an impedance measurement mode. Switching between the two modes can be achieved by controlling their operation at different times. In practical use, for example, impedance measurement operates for 10 minutes every 48 hours, while the electric field therapy mode is used for the remaining time. In electric field therapy mode, the voltage is a set voltage, and the frequency is fixed at 200kHz. In impedance measurement mode, the voltage is fixed at 100Vpp, and measurements are taken within a frequency range of 1-150kHz. Each frequency corresponds to a measured impedance value, thus obtaining an impedance measurement curve. Comparing this curve with the impedance measurement curve of normal tissue reveals the growth status of the tumor area. Based on the growth status of the tumor area, the output voltage in the electric field therapy mode can be adjusted accordingly to apply the optimal electric field conditions to that area, achieving closed-loop automatic adjustment and thereby improving the overall treatment effect.

[0066] In the electric field therapy mode and the impedance measurement mode, the flexible electrode 20 and the second electrode 30 work together to generate an alternating electric field that can basically cover the entire tumor cavity R and its sidewalls, thereby improving the electric field therapy effect and accurately measuring the impedance value of the entire tumor cavity R.

[0067] The electric field therapy device has a closed-loop control function. The flexible electrode 20 and the second electrode 30 can not only be used to apply the electric field, but also to measure the impedance value of the tumor tissue. The impedance value is used as a reference for the growth of the tumor, and then the application parameters of the electric field are adjusted to find the best treatment parameters for each patient.

[0068] Example 5

[0069] This embodiment provides an electric field therapy device, which has a structure that is largely the same as that of Embodiment 1, Embodiment 2, Embodiment 3, or Embodiment 4, except that:

[0070] Please see Figure 6 The U-shaped flexible electrode 20 includes an insertion segment and an extension segment 211, which are at a certain angle to each other, for example, perpendicular to each other. This is mainly determined by the shape of the tumor cavity R and the surface curvature of the brain tissue surrounding the tumor cavity R. The insertion segment is located inside the tumor cavity R, and the two insertion segments are attached to the wall of the tumor cavity and positioned opposite each other. The bottoms of the two insertion segments are tangentially transitioned together by an arc segment, and the tops of the insertion segments are tangentially transitioned together with the extension segment 211 by another arc segment. That is, along the length direction of the flexible electrode 20, the flexible base layer 21 is composed of the extension segment 211, the arc segment, the insertion segment, the arc segment, the insertion segment, the arc segment, and the extension segment 211 in sequence.

[0071] This embodiment refines the Z-shaped design of the flexible electrode 20, ensuring a smooth transition at the bends of the flexible electrode 20. This not only avoids bending damage to the flexible electrode 20 but also improves the patient's physiological tolerance to the flexible electrode 20.

[0072] Example 6

[0073] This embodiment provides an electric field therapy device, which has a structure that is generally the same as that of Embodiment 1, Embodiment 2, Embodiment 3, Embodiment 4, or Embodiment 5, except that:

[0074] Please see Figure 3 or Figure 6 The extension direction of the flexible conductor 23 does not intersect with the through hole 212, and the through holes 212 are symmetrically arranged on both sides of the flexible conductor 23 according to the total number.

[0075] This embodiment refines the layout of the through hole 212. Without affecting the fixation of the through hole 212 and the brain tissue 102, the through hole 212 provides a connection path for the flexible wire 23, which facilitates the electrical connection between the flexible wire 23 and the electrode unit 22.

[0076] The above embodiments are only for illustrating the technical concept and features of the present invention, and are intended to enable those skilled in the art to understand the content of the present invention and implement it. They should not be used to limit the scope of protection of the present invention. All equivalent changes or modifications made in accordance with the spirit and essence of the present invention should be covered within the scope of protection of the present invention.

Claims

1. An implantable electrode for the treatment of intracranial tumors, characterized in that, include: The flexible electrode (20) includes a flexible substrate layer (21) and at least one electrode unit (22) disposed on the flexible substrate layer (21); at least one end of the flexible substrate layer (21) is not covered by the electrode unit (22), and the portion of the flexible substrate layer not covered by the electrode unit (22) has an extension segment (211). The electrode unit (22) of the flexible electrode (20) is used to be placed in the tumor cavity (R) formed after tumor resection, and the extension (211) is used to be attached to the surface of the brain tissue (102) outside the tumor cavity (R).

2. The implantable electrode for intracranial tumor treatment according to claim 1, characterized in that: Along the length of the flexible substrate (21), the flexible electrode (20) includes at least two electrode units (22) spaced apart on the flexible substrate (21), with the two electrode units (22) located at the non-ends of the flexible substrate (21).

3. The implantable electrode for intracranial tumor treatment according to claim 2, characterized in that: The flexible electrode (20) is bent into a Z-shape in the implanted state, wherein at least two electrode units (22) are located in the tumor cavity (R) and are arranged opposite each other at intervals, and the two electrode units (22) are arranged to generate an alternating electric field; The flexible base layer (21) has two extension segments (211) at its two ends. The two extension segments (211) of the flexible base layer (21) are used to extend out of the tumor cavity (R) in opposite directions and attach to the surface of the brain tissue (102) outside the tumor cavity (R).

4. The implantable electrode for intracranial tumor treatment according to claim 1, characterized in that: The electrode unit (22) includes a flexible substrate layer (221), a conductive layer (222), and an encapsulation layer (223) that are sequentially stacked on the flexible substrate layer (21).

5. The implantable electrode for intracranial tumor treatment according to claim 4, characterized in that: The flexible substrate layer (21) is made of at least one of polydimethylsiloxane, polyethylene terephthalate, polyimide, or polyethylene; the flexible substrate layer (221) is made of at least one of thermoplastic polyurethane or medical silicone; the conductive layer (222) is made of at least one of carbon nanotubes, graphene, polythiophene, polyaniline, polypyrrole, gold, silver, or platinum-iridium alloy; and the encapsulation layer (223) is made of at least one of polydimethylsiloxane, polyethylene terephthalate, polyimide, and a composite high dielectric constant material containing inorganic nanoparticles as fillers.

6. The implantable electrode for intracranial tumor treatment according to claim 4, characterized in that: The conductive layer (222) is rectangular in shape, or The conductive layer (222) includes a long strip-shaped main trunk (2221) and several spaced branches (2222), wherein the several spaced branches (2222) are integrally connected to one side of the same main trunk (2221).

7. The implantable electrode for intracranial tumor treatment according to any one of claims 1 to 6, characterized in that: The extension (211) of the flexible electrode (20) is provided with a plurality of through holes (212) penetrating the flexible substrate (21).

8. An electric field therapy device, characterized in that: include: Control module; and An implantable electrode for treating intracranial tumors according to any one of claims 1 to 7, wherein the implantable electrode for treating intracranial tumors is electrically connected to the control module for generating an alternating electric field by the implantable electrode; Wherein, the implantable electrode for intracranial tumor treatment comprises at least two electrodes, or the implantable electrode for intracranial tumor treatment comprises at least two electrode units (22).

9. The electric field therapy device according to claim 8, characterized in that: The flexible electrode (20) is the first electrode. The control module is electrically connected to the flexible electrode (20). The electrode unit (22) of the flexible electrode (20) is used to be placed in the tumor cavity (R) formed after tumor resection. The extension segment (211) of the flexible electrode (20) is used to extend out of the tumor cavity (R) and attach to the surface of the brain tissue (102) outside the tumor cavity (R). The electric field therapy device also includes at least one second electrode (30), which is also electrically connected to the control module and is used for implantation outside the tumor cavity (R). The control module is configured to enable an alternating electric field to be formed between the flexible electrode (20) and at least one second electrode (30).

10. The electric field therapy device according to claim 9, characterized in that: The second electrode (30) is used for implantation at a location below the skull (105) and above the dura mater.

11. The electric field therapy device according to claim 9, characterized in that: The electric field therapy device has an electric field therapy mode and an impedance measurement mode.

12. The electric field therapy device according to claim 11, characterized in that: In the electric field therapy mode, the control module delivers alternating current of a certain frequency to the flexible electrode (20) or to the flexible electrode (20) and the second electrode (30) to apply an electric field to the tumor cells in the target area; and / or, In the impedance measurement mode, the control module supplies alternating current of a certain frequency range to the flexible electrode (20) or to the flexible electrode (20) and the second electrode (30) to measure the impedance value of the target area.

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