Implantable electrode device and electric field therapy system

Abstract

The application provides an implantable electrode device and an electric field treatment system for intracranial tumor treatment. The implantable electrode device comprises a spherical support, a flexible electrode sheet arranged on the outer surface of the spherical support, and a wing-shaped sheet connected with the spherical support. The spherical support supports the flexible electrode sheet for implanting into a tumor cavity, and the wing-shaped sheet is arranged above the tumor cavity and is clamped on the surface of brain tissue outside the tumor cavity at both ends, so that the whole electrode device is kept stable in position and has small damage to the tissue. In addition, the application discloses an electric field treatment system, which comprises an electric field generator and the implantable electrode device electrically connected with the electric field generator. Since the implantable electrode device is arranged in the tumor cavity and kept stable in position, the electric field treatment system has more stable electric field effect on the tumor area, more accurate treatment targeting, and better treatment effect.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to an implantable electrode device and an electric field therapy system. 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 core component of tumor electric field therapy devices used in clinical practice is the external electrode, and its main structure is shown in the attached figure. 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 drawbacks of the external electrode approach: First, it generates significant heat, which can cause scalp inflammation, allergies, and other adverse reactions; second, the effect is unstable, requiring frequent replacement and reattachment of the electrode during treatment, and the placement cannot be strictly consistent each time, leading to varying electric field effects applied to the tumor area; third, patient compliance is poor because attaching the external electrode requires shaving the hair, which can easily cause scalp inflammation, allergies, and other issues during wear, reducing the time patients spend wearing the device, while the treatment effect is directly and positively correlated with the wearing time.

[0005] Current implantable research, by embedding electrodes within the tumor resection cavity, largely solves the problems associated with external electrodes. However, after implantation, existing implantable electrodes are often led out via leads, which are then fixed outside the cavity using screws, adhesives, or sutures. Firstly, this method easily leads to instability in the electrode's position within the tumor resection cavity, thus affecting the electric field effect. Secondly, using adhesives raises biocompatibility issues, posing a risk of chronic adverse reactions such as inflammation and allergies; while using screws or sutures often further increases the risk of intracranial injury.

[0006] To address these issues, existing technologies focus on implanting electrodes into intracranial tumor sites. For example, some studies have placed electrode contacts on malleable electrode frames. After implantation in the target area, the electrode device can adapt its shape to fit the inner wall of the target area, improving electric field coverage. However, these electrode devices typically use screws, threaded wires, or sutures to fix the electrode fixation part to the skull or dura mater. The entire device is then secured by a guide mechanism connected to the electrode fixation part. This results in a complex structure, the fixation method is prone to causing secondary damage, and the electrode frame's direct contact with the inner wall of the tumor resection cavity can easily cause injury. Furthermore, the procedure requires a high level of skill from the surgeon. Summary of the Invention

[0007] To address the aforementioned problems, the present invention aims to provide an implantable electrode device, comprising a spherical support, wherein the spherical support is formed by multiple support strips to create a hollow spherical structure; a flexible electrode sheet disposed on the outer surface of the spherical support; and an airfoil, wherein the airfoil is elongated and the non-ends of the airfoil are connected to the spherical support.

[0008] In at least one embodiment, the support strips of the spherical bracket are warp lines, with the leading ends of multiple warp lines fixed at a point to form the top of the spherical bracket, and the trailing ends of multiple warp lines fixed at a point to form the bottom of the spherical bracket. The airfoil is assembled onto the top of the spherical bracket. Preferably, the multiple warp lines are evenly distributed around the axis of the spherical bracket. More preferably, the number of warp lines is even.

[0009] In at least one embodiment, a fixing hole is provided at the top center of the spherical bracket, and an mounting hole is provided in the middle of the airfoil. The mounting hole of the airfoil can be installed in correspondence with the fixing hole at the top of the spherical bracket.

[0010] In at least one embodiment, the flexible electrode sheet includes at least two electrode units, and the flexible electrode sheet is disposed on the outer surface of the warp line.

[0011] In at least one embodiment, the number of warp lines is twice the number of flexible electrode sheets, the flexible electrode sheets are bent around the outer surfaces of two symmetrical warp lines, and the two electrode units of the flexible electrode sheets are arranged opposite each other at intervals.

[0012] In at least one embodiment, the flexible electrode sheet has fixing holes at both ends, and the flexible electrode sheet is assembled with the top of the spherical bracket and the middle part of the airfoil through its fixing holes.

[0013] In at least one embodiment, the width of the flexible electrode sheet is greater than the width of the warp line, such that the flexible electrode sheet covers the warp line.

[0014] In at least one embodiment, the number of flexible electrode sheets is at least two, and a gap is formed between two adjacent flexible electrode sheets that can communicate with the interior of the spherical support.

[0015] In at least one embodiment, a sensor is suspended inside the spherical support for measuring the viscosity and / or density of cerebrospinal fluid.

[0016] In at least one embodiment, the number of airfoils is at least two, and the two or more airfoils are arranged in an intersecting manner, with the spherical support connected to the intersecting portion of the two or more airfoils. Preferably, the two or more airfoils share the intersecting portion.

[0017] In at least one embodiment, the spherical support supports the flexible electrode sheet for placement in the tumor cavity formed after tumor resection, and the two ends of the wing-shaped sheet are used to extend and be secured to the surface of brain tissue outside the tumor cavity.

[0018] In at least one embodiment, the flexible electrode sheet further includes a flexible substrate layer, and 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.

[0019] 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 silicone; the conductive layer is made of at least one of carbon nanotubes, graphene, polythiophene, polyaniline, polypyrrole, gold, silver, or platinum-iridium alloy; and the encapsulation layer is made of at least one of polydimethylsiloxane, polyethylene terephthalate, polyimide, and a composite high dielectric constant material containing inorganic nanoparticles as fillers.

[0020] In at least one embodiment, the material of the spherical scaffold includes at least one of medical polyurethane, polylactic acid, polyimide, or polyethylene; and the material of the wing-shaped sheet is at least one of polydimethylsiloxane, polyethylene terephthalate, polyimide, or polyethylene.

[0021] In at least one embodiment, the airfoil is an elongated membrane, and the two ends of the airfoil are provided with a plurality of through holes penetrating the airfoil.

[0022] Another object of the present invention is to provide an electric field therapy system, including an electric field generator and the above-described implantable electrode device, wherein the implantable electrode device is electrically connected to the electric field generator and is used to generate an alternating electric field by the flexible electrode sheet.

[0023] In at least one embodiment, the electric field therapy system further includes at least one extratumoral electrode, which is electrically connected to the electric field generator and is used for implantation outside the tumor cavity. The electric field generator is configured to generate an alternating electric field between the flexible electrode sheet and the extratumoral electrode. Preferably, the extratumoral electrode is used for implantation at a location below the skull and above the dura mater.

[0024] Compared with existing technologies, the implantable electrode device of the present invention has the following advantages:

[0025] (1) Compared with existing external electrodes, the implantable electrode device provided by this invention is directly implanted into the tumor cavity after tumor resection, avoiding the obstruction of high-resistance tissues such as the skull and scalp. It is more precise in targeting and can apply the best treatment intensity to the residual tumor area and its surrounding tissues, producing a considerable therapeutic effect with a relatively low energy input. Moreover, it has few adverse reactions, does not cause obvious fever, and is less likely to cause scalp inflammation or allergies.

[0026] (2) Compared with existing implantable electrodes, by setting a spherical scaffold and a flexible electrode sheet set on the outer surface of the spherical scaffold, and a wing-shaped sheet connected to the spherical scaffold, the spherical scaffold supports the flexible electrode sheet for placement in the tumor cavity formed after tumor resection, and the wing-shaped sheet spans above the tumor cavity with its two ends locked onto the surface of brain tissue outside the tumor cavity, the position of the entire electrode device in the tumor cavity is very stable, thus the electric field effect on the tumor treatment area is more stable and the treatment effect is better; in addition, the sheet-like flexible electrode sheet set on the outer surface of the spherical scaffold is less likely to cause secondary damage to the tissue in the tumor cavity, and the patient compliance is high; in addition, the structure of the wing-shaped sheet assembled on the spherical scaffold facilitates the implantation and removal of the entire device in the tumor cavity.

[0027] (3) Furthermore, the implantable electrode device of the present invention can measure the density and / or viscosity of cerebrospinal fluid at regular intervals by setting sensors, thereby monitoring whether there is intracranial infection and tumor growth characteristics, etc. Based on the measurement feedback data, timely and reasonable treatment measures can be taken for each patient, or the electric field parameters can be adjusted to the optimal electric field conditions to achieve closed-loop automatic adjustment.

[0028] (4) In addition, in the electric field therapy system provided by the present invention, since the relative position of the implanted electrode device in the tumor cavity is stable and the surface friction with the brain tissue is small, the targeting of tumor electric field therapy can be significantly improved, the electric field stability of the relevant area can be improved, and the patient's compliance can be improved, and adverse reactions can be reduced, thereby improving the overall treatment effect. Attached Figure Description

[0029] 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.

[0030] Figure 1 This is a schematic diagram illustrating the usage state of one embodiment of the adhesive electrode in the prior art;

[0031] Figure 2 This is a schematic diagram of the usage state of one embodiment of the electric field therapy system of the present invention;

[0032] Figure 3 This is a schematic diagram of one embodiment of the implantable electrode device of the present invention;

[0033] Figure 4 yes Figure 3 A plan view of one embodiment of the flexible electrode sheet in the diagram;

[0034] Figure 5 yes Figure 4 A schematic diagram of a composite structure of an electrode unit of a flexible electrode sheet in one embodiment;

[0035] Figure 6 yes Figure 5 Shape contour diagram of the conductive layer of the flexible electrode sheet;

[0036] Figure 6 (a) is a shape outline diagram of the conductive layer of the flexible electrode sheet in the first embodiment;

[0037] Figure 6 (b) is a shape outline diagram of the conductive layer of the flexible electrode sheet in the second embodiment;

[0038] Figure 6 (c) is a shape outline diagram of the conductive layer of the flexible electrode sheet in the third embodiment;

[0039] Figure 6 (d) is a shape outline diagram of the conductive layer of the flexible electrode sheet in the fourth embodiment;

[0040] Figure 6 (e) is a shape outline diagram of the conductive layer of the flexible electrode sheet in the fifth embodiment;

[0041] Figure 6 (f) is a shape outline diagram of the conductive layer of the flexible electrode sheet in the sixth embodiment;

[0042] Figure 7 yes Figure 3 A schematic diagram of the spherical scaffold for an implantable electrode device;

[0043] Figure 8 It is Figure 4 A schematic diagram showing the relative positions of the flexible electrode sheets assembled on the spherical support.

[0044] Figure 9 It is Figure 4 A schematic diagram showing the relative positions of the flexible electrode sheets after they are assembled onto the spherical support.

[0045] Figure 10 It combines sensors, airfoils and Figure 9 A schematic diagram showing the relative positions of the spherical support before assembly;

[0046] Figure 11 This is a schematic diagram of the usage state of one embodiment of the electric field therapy system of the present invention;

[0047] Figure 12 This is a shape outline diagram of the conductive layer of the external electrode of the tumor cavity in this invention;

[0048] Figure 12(a) is a shape outline diagram of the conductive layer of the external electrode of the tumor cavity in the first embodiment;

[0049] Figure 12 (b) is a shape outline diagram of the conductive layer of the external electrode of the tumor cavity in the second embodiment;

[0050] Figure 12 (c) is a shape outline diagram of the conductive layer of the external electrode of the tumor cavity in the third embodiment;

[0051] Figure 12 (d) is a shape outline diagram of the conductive layer of the external electrode of the tumor cavity in the fourth embodiment;

[0052] Figure 12 (e) is a shape outline diagram of the conductive layer of the external electrode of the tumor cavity in the fifth embodiment.

[0053] Explanation of reference numerals in the attached figures

[0054] 101-Attached electrode; 102-Brain tissue; 103-Tumor; 104-Scalp; 105-Skull; 20-Implantable electrode device; 21-Flexible electrode sheet; 211-Flexible substrate layer; 212-Electrode unit; 2121-Flexible substrate layer; 2122-First conductive layer; 21221-Main trunk; 21222-Branch; 21223-Conductive sheet; 2123-Encapsulation layer; 213-Flexible wire; 214 - First mounting hole; 215 - Gap; 22 - Spherical bracket; 221 - Meridian line; 223 - Second mounting hole; 225 - Hollow cavity; 23 - Airfoil; 231 - Third mounting hole; 24 - Sensor; 241 - Forked bar; 242 - Threaded hole; 25 - Screw; 30 - External electrode of the cavity; 31 - Second conductive layer; 311 - Fixing hole; 312 - Radial bar; 313 - Circular bar; 314 - Swirl bar; R - Cavity. Detailed Implementation

[0055] The present invention will be further described in detail below with reference to specific embodiments.

[0056] Example 1

[0057] Please see Figure 2 This embodiment provides an electric field therapy system, including a control module and an implantable electrode device 20. The implantable electrode device 20 is electrically connected to the control module (not shown) for use in intracranial tumor electric field therapy.

[0058] Please see Figure 3 , Figure 4 , Figure 7 and Figure 11The implantable electrode device 20 includes a flexible electrode sheet 21, a spherical support 22, and an wing-shaped sheet 23. The spherical support 22 is a hollow spherical structure formed by multiple support strips. The spherical structure described in this invention includes spherical, near-spherical, ellipsoidal, or other similar spherical structures (e.g., polygons with rounded corners). This facilitates the stable retention of the implantable electrode device within the tumor cavity (R) after tumor resection during use, and avoids sharp edges that could easily cause tissue damage. The flexible electrode sheet 21 is disposed on the outer surface of the spherical support 22. Due to its good flexibility and deformability, the flexible electrode sheet 21, disposed on the outer surface of the spherical support, reduces or even eliminates direct contact between the support strips of the spherical support and the tissue, thereby reducing friction between the implantable electrode device and the tissue, reducing the risk of tissue damage, and enhancing the safety of the implantable electrode device. The non-end portion, preferably the middle portion, of the wing-shaped sheet 23 is connected to the spherical support 22. The wing-shaped plate 23 is positioned across the tumor cavity (R) and its two ends are engaged with the surface of the brain tissue (102) outside the tumor cavity (R). This further secures the implantable electrode device and increases its stability. It also facilitates the implantation and removal of the entire device within the tumor cavity.

[0059] In this embodiment, the support strip of the spherical bracket 22 is a warp strip 221. The head ends of multiple warp strips 221 are fixed at a point to form the top of the spherical bracket 22, and the tail ends of multiple warp strips 221 are fixed at a point to form the bottom of the spherical bracket 22. The flexible electrode sheet 21 is attached to the outside of the warp strip 221, and the airfoil 23 is assembled on the top of the spherical bracket 22.

[0060] The flexible electrode sheet 21 includes a flexible substrate layer 211, at least two electrode units 212 disposed on the flexible substrate layer 211, and at least two flexible wires 213. One end of each flexible wire 213 is electrically connected to the electrode unit 212, and the other end extends out of the flexible substrate layer 211 to be electrically connected to the control module.

[0061] The spherical support 22 supports the flexible electrode sheet 21 and is placed within the tumor cavity R to generate an alternating electric field between the two electrode units 212. The wing-shaped sheet 23 is elongated, with its central region assembled with the spherical support 22 or the flexible electrode sheet 21. Both ends of the wing-shaped sheet 23 extend out of the tumor cavity R to be secured to the surface of the brain tissue 102 outside the tumor cavity R. Preferably, there are at least two wing-shaped sheets, with the non-end portions of two or more wing-shaped sheets intersecting at a point. The spherical support is connected to the intersecting portion of the two or more wing-shaped sheets. The two or more wing-shaped sheets share the intersecting portion. In this embodiment, there are two wing-shaped sheets 23, which are arranged crosswise, with their ends extending in different directions.

[0062] The number of warp lines 221 is twice the number of flexible electrode sheets 21. Each flexible electrode sheet 21 is bent and attached to two opposing warp lines 221, and the two electrode units 212 are spaced apart and opposite to each other to generate an alternating electric field. In a preferred embodiment, the directions in which the two flexible electrode sheets 21 are wrapped around the spherical support 22 are perpendicular to each other, so that the directions of the electric fields generated by the two flexible electrode sheets 21 are perpendicular to each other. The number of warp lines 221 is at least 4, and preferably 4, 6, or 8.

[0063] The width of the meridian line 221 is no greater than the width of the flexible electrode sheet 21, allowing the flexible electrode sheet 21 to completely cover the meridian line 221, thus ensuring that the meridian line 221 does not directly contact the brain tissue and cause damage. The flexible electrode sheet 21 has an extremely thin sheet-like structure, specifically a square, rectangular, or other arbitrary irregular shape. The flexible electrode sheet 21 has good flexibility and deformability, and its thickness can be 50μm to 1mm, thus it can adhere to the spherical scaffold 22 and the inner wall of the tumor cavity R by surface adhesion. In this embodiment, the flexible electrode sheet 21 is a long rectangular strip with first mounting holes 214 at both ends. The center distance between the two first mounting holes 214 is approximately equal to the perimeter of the outer wall of the spherical scaffold 22. This allows the flexible electrode sheet 21 to be easily mounted around the two symmetrical meridian lines 221 of the spherical scaffold 22.

[0064] Please see Figure 4 and Figure 5The electrode unit 212 of the flexible electrode sheet 21 includes a flexible substrate layer 2121, a first conductive layer 2122, and an encapsulation layer 2123 covering the flexible substrate layer 2121 and the first conductive layer 2122, which are sequentially stacked on the surface of the flexible substrate layer 211. The flexible substrate layer 211 can be made of materials such as polydimethylsiloxane (PDMS), polyethylene terephthalate (PET), polyimide (PI), or polyethylene (PE). The flexible substrate layer 2121 has good deformability during application, does not break when bent, and is beneficial for electrodeposition. Common deformation types include bending, shaping, uniaxial tension, biaxial tension, and radial tension. Common materials include thermoplastic polyurethane (TPU) and medical silicone. The first conductive layer 2122 must possess good conductivity. Experimental studies have shown that suitable materials include 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 encapsulation layer 2123 can be made of one or more of the following: polydimethylsiloxane (PDMS), polyimide (PI), polyethylene terephthalate (PET), and composite high-dielectric-constant materials containing inorganic nanoparticles as fillers. These inorganic nanoparticles can be titanium dioxide, ferroelectric nanoparticles, barium titanate (BaTiO3), etc.

[0065] Examples of selectable shapes for the first conductive layer 2122 include: Figure 6 As shown, Figure 6 As shown in (a), the first conductive layer 2122 can be a basic rectangle. The shape of the first conductive layer 2122 can also consist of a long, narrow main trunk 21221 and branches 21222, with several spaced branches 21222 integrally connected to one side of the same main trunk 21221. Several conductive sheets 21223, which expand the width of the branches 21222, can also be arranged at intervals on the branches 21222. The shape of the conductive sheets 21223 can be one or more of the following: circular, rectangular, rhomboid, and hexagonal. Figure 6 As shown in (b), the trunk 21221 and branches 21222 are each rectangular strips in shape. Figure 6 As shown in (c), the conductive sheet 21223 has a circular outline. Figure 6 As shown in (d), the conductive sheet 21223 has a rectangular outline. Figure 6 As shown in (e), the conductive sheet 2223 itself has a rhomboid outline. Figure 6As shown in (f), the conductive sheet 21223 has a hexagonal outline. By setting the main trunk 21221, branches 21222 and conductive sheet 21223 in the first conductive layer 2122, the electrode unit 212 can generate an electric field of the required intensity and direction, while increasing the flexibility of the flexible electrode sheet 21, thereby making the adhesion to the spherical support 22 and the inner wall of the aneurysm cavity R more firm.

[0066] In this embodiment, the spherical support 22 is as follows: Figure 7 As shown, the structure resembles a lantern frame, with a second assembly hole 223 at the top center. The material can be medical-grade polyurethane, polylactic acid, polyimide, polyethylene, etc. The wing-shaped sheet 23 is a long strip-shaped film made of a polymer material, such as polydimethylsiloxane (PDMS), polyethylene terephthalate (PET), polyimide (PI), polyethylene (PE), etc.

[0067] When assembling the implantable electrode device 20 provided in this embodiment, please refer to [link / reference]. Figures 7 to 10 After the flexible electrode sheet 21 is bent around the outside of the line 221, its two first mounting holes 214 correspond to the second mounting holes 223 of the spherical bracket 22 for assembly. Similarly, one or more other flexible electrode sheets 21 can be provided. Then, the airfoil 23 is assembled on the top of the spherical bracket 22. At this time, the first mounting holes 214, the second mounting holes 223, and the third mounting holes 231 correspond, and screws 25 are used to pass through the first mounting holes 214, the second mounting holes 223, and the third mounting holes 231 in sequence to achieve fixation. In other embodiments, other methods (such as adhesive) can also be used to fix the flexible electrode sheet 21, the spherical bracket 22, and the airfoil 23.

[0068] Compared to existing external electrodes, the implantable electrode device 20 of this embodiment is directly implanted into the tumor cavity R after tumor resection, resulting in more precise targeting. Optimal treatment intensity can be applied to nearby residual tumor areas. Adverse reactions are minimal; there is no significant fever, and it is less likely to cause scalp inflammation or allergies because the internal electrode of this invention avoids obstruction from high-resistance tissues such as the skull and scalp. Please refer to [link / reference]. Figure 11In practical application, the flexible electrode pads 21 of this implantable electrode device 20 are attached to the outside of the spherical support 22 to prevent compression of brain tissue and to be stably placed within the tumor cavity R. The surface of the flexible electrode pads 21 can be attached to the inner wall of the tumor cavity R. Compared with directly setting electrodes on the spherical support 22, this reduces the difficulty of processing. The flexible sheet-like structure of the flexible electrode pads 21 can also reduce pressure on the brain tissue 102, with less friction on the surface of the brain tissue, thus reducing additional damage. Furthermore, the electric field direction of the entire device during treatment can be controlled by adjusting the number and extension direction of the meridian lines 221, the number of flexible electrode pads 21, and the number and layout of the electrode units 212, thereby improving the electric field therapy effect. In addition, by setting wing-shaped plates 23 to be assembled on the flexible electrode pads 21 or the spherical support 22, the two ends of the wing-shaped plates 23 can extend out of the tumor cavity R and be secured to the surface of the brain tissue 102, making the entire device easy to install and remove, and ensuring the stability of the entire device.

[0069] Example 2

[0070] This embodiment provides an electric field therapy system, including a control module and an implantable electrode device 20. The implantable electrode device 20 has a basically the same structure as that in Embodiment 1, except that:

[0071] Please see Figure 3 and Figure 11 The spherical scaffold 22 has multiple warp lines 221 forming a hollow cavity 225, and a flexible base layer 211 is attached to the outside of the warp lines 221 relative to the hollow cavity 225. A gap 215 is formed between two adjacent flexible electrode pads 21, which connects to the hollow cavity 225, allowing cerebrospinal fluid in the aneurysm cavity R to enter the interior of the spherical scaffold 22, i.e., the hollow cavity 225, thereby making the relative position of the implanted electrode device 20 within the aneurysm cavity R more stable.

[0072] Understandably, in order to clearly and unobstructed display the relative positions of all components, Figure 3 It contains only one flexible electrode sheet 21 and one airfoil sheet 23.

[0073] In practical applications, an alternating electric field can be generated between the electrode units 212 of two adjacent flexible electrode sheets 21, thereby producing an electric field direction along the sidewall of the tumor cavity R. Similarly, multiple electrode units 212 can be arranged side by side along the width direction of a flexible electrode sheet 21. In this embodiment, the spherical support 22, in conjunction with the flexible electrode sheet 21, can maximize the widening of the electric field direction within the tumor cavity R, thereby enhancing the tumor treatment effect. Furthermore, the spherical structure allows the entire device to be more stably placed within the tumor cavity R.

[0074] In some embodiments, each wing-shaped piece 23 may have multiple through holes (not shown) at both ends, and the through holes can be arranged arbitrarily. Preferably, the through holes are arranged with a certain distribution density. By providing through holes at both ends of the wing-shaped piece 23, it is easier for brain tissue to migrate and grow on its surface, and it is also more helpful for the fixation of the entire device.

[0075] Example 3

[0076] This embodiment provides an electric field therapy system, including a control module (not shown) and an implantable electrode device 20. The implantable electrode device 20 has a basically the same structure as that in Embodiment 2, except that:

[0077] Please see Figure 3 and Figure 11 The implantable electrode device 20 also includes a sensor 24, which is suspended within the hollow cavity 225 and used to measure the viscosity and density of cerebrospinal fluid. Cerebrospinal fluid within the tumor cavity R can enter the hollow cavity 225 through the gap 215 between the flexible electrode pieces 21, thereby providing a liquid-filled microenvironment for the internal sensor 24, facilitating measurement.

[0078] In this embodiment, the sensor 24 is a piezoelectric resonant sensor, whose core component is a resonator. The resonator consists of a crystal such as quartz or lithium niobate in the center, with positive and negative electrodes connected to both sides. When an AC voltage is applied to the positive and negative electrodes, the quartz crystal undergoes mechanical deformation due to its inverse piezoelectric properties, causing the entire device to resonate. The resonant frequency of the sensor 24, immersed in the liquid to be measured, changes with the liquid. Based on this characteristic, the viscosity and density of the liquid can be detected.

[0079] In this embodiment, the sensor 24 includes a forked bar 241 and a threaded hole 242 located at the top of the forked bar 241. The difference between this implantable electrode device 20 and that in Embodiment 1 lies in the following during assembly:

[0080] Please see Figure 10 and Figure 11 The sensor 24 is placed in the hollow cavity 225 of the spherical bracket 22. The threaded hole 242 at the top of the sensor corresponds to the first assembly hole 214, the second assembly hole 223 and the third assembly hole 231. The assembly can be completed by passing the screw 25 through the third assembly hole 231, the first assembly hole 214, the second assembly hole 223 and the threaded hole 242 in sequence.

[0081] The implantable electrode device 20 provided in this embodiment has closed-loop operation characteristics. The sensor 24 can periodically measure the density and viscosity of cerebrospinal fluid to reflect intracranial infection and tumor growth characteristics. Based on the measurement feedback data, timely and appropriate treatment measures are taken for each patient, or the electric field parameters are adjusted to the optimal electric field conditions to achieve closed-loop regulation and treatment.

[0082] Example 4

[0083] Please see Figure 2 and Figure 11 This embodiment provides an electric field therapy system, which has a structure that is generally the same as that of Embodiment 1, Embodiment 2 or Embodiment 3. The difference is that the electric field therapy device further includes at least one external electrode 30 of the tumor cavity. The external electrode 30 of the tumor cavity 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 sheet 21 and the external electrode 30 of the tumor cavity, thereby widening the direction of the electric field, reducing the treatment blind zone of the electric field effect, and enhancing the tumor treatment effect.

[0084] Specifically, the extratumoral electrode 30 can be implanted below the skull 105 and above the dura mater. The overall structure and material composition of the extratumoral electrode 30 are roughly the same as those of the flexible electrode pad 21. Understandably, in practical applications, one or more extratumoral electrodes 30 can be placed in all peritumoral areas, and the electric field direction can be periodically changed between the extratumoral electrode 30 and multiple flexible electrode pads 21 to optimize the electric field therapy effect.

[0085] In this embodiment, the electrode unit of the external electrode 30 of the tumor cavity has a second conductive layer 31, the material of which can be selected to be similar to the first conductive layer 2122, and the shape can be selected as follows: Figure 12 As shown. Figure 12 (a) to Figure 12 As shown in (e), the second conductive layer 31 in the external electrode 30 of the tumor cavity includes two or more fixing holes 311, allowing the external electrode 30 of the tumor cavity to be fixed to the inner surface of the skull 105 via titanium screws. The shape and outline of the second conductive layer 31 can be rectangular, circular, or annular, or as shown in (e). Figure 12 As shown in (d), there are several concentric annular bars 313, which are integrally connected in the shape of radial bars 312, or as shown in (d). Figure 12 The shape of the vortex bar 314 is shown in (e); the fixing holes 311 are arranged at intervals along the vortex trajectory of the vortex bar 314. The various shapes of the second conductive layer 31 facilitate installation and fixation in practical applications and generate an electric field of the required direction and intensity as needed.

[0086] Example 5

[0087] This embodiment provides an electric field therapy system, which has a structure that is largely the same as that of Embodiment 1, Embodiment 2, Embodiment 3, or Embodiment 4, except that:

[0088] Please see Figure 7 The spherical support 22 gradually widens from its middle towards its top or bottom along the line 221.

[0089] This embodiment refines the specific shape of the spherical bracket 22. First, the top of the spherical bracket 22 has sufficient area to set the second mounting hole 223. Second, each warp line 221 is an arch bridge shape that is thick at both ends and thin in the middle, so the warp line 221 has strong shape stability and can maintain its own arch bridge shape.

[0090] Example 6

[0091] This embodiment provides an electric field therapy system, 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:

[0092] Please see Figure 4 The flexible electrode sheet 21 in its unfolded planar state has electrode units 212 located on the same side of the flexible substrate layer 211. Flexible wires 213 extending from both ends of the electrode units 212 are connected to each electrode unit 212. Each flexible electrode sheet 21 has two electrode units 212, and the two electrode units 212 with flexible wires 213 on the same flexible substrate layer 211 are arranged in a centrally symmetrical manner. The two first mounting holes 214 on the same flexible substrate layer 211 are arranged in a mirror-symmetrical manner.

[0093] In this embodiment, the two flexible wires 213 are arranged in a centrally symmetrical manner. This is to avoid the first mounting hole 214 on the flexible base layer 211, and also to ensure that when the first mounting hole 214 is in a closed loop state, the two wires 213 can avoid each other and be connected to the external wires respectively.

[0094] Example 7

[0095] This embodiment provides an electric field therapy system, which has a structure largely the same as that of Embodiments 1, 2, 3, 4, 5, or 6, with the difference being:

[0096] Please see Figure 3 The length of the airfoil 23 is greater than the diameter of the outer wall of the flexible electrode 21 in its annular state. Meanwhile, the length of the sensor 24 is less than the diameter of the inner wall of the spherical support 22.

[0097] The length of the wing-shaped flap 23 in this embodiment is limited to ensure that it has sufficient length to extend beyond the tumor cavity R and be secured to the surface of the brain tissue 102 outside the tumor cavity R. The diameter of the spherical support 22 in this embodiment is limited to ensure that the sensor 24 is suspended and that the bottom of the sensor 24 does not directly contact the spherical support 22 or the flexible electrode sheet 21, thereby ensuring that the sensor 24 accurately participates in the measurement without being bumped.

[0098] Please see Figure 3For example, the screw 25 in this embodiment has an exposed head, the diameter of which is equal to the width of the airfoil 23.

[0099] First, the exposed head of the screw 25 provided in this embodiment ensures sufficient surface contact with the airfoil 23, thereby guaranteeing the stability of the assembly of the flexible electrode 21, the spherical support 22, the airfoil 23, and the sensor 24. Furthermore, the exposed head of the screw 25 has a circular outline, making tangential contact with both sides of the airfoil 23. This also helps to maintain the straightness of the airfoil 23 to some extent, reducing the probability of warping.

[0100] Example 8

[0101] This embodiment provides an electric field therapy system, which is substantially the same in structure as Embodiments 1, 2, 3, 4, 5, 6, or 7, except that:

[0102] When there is more than one flexible electrode sheet 21, the inner wall of one flexible electrode sheet 21 and the outer wall of another flexible electrode sheet 21 are in surface contact and fixed together. Also, please refer to... Figure 11 When there is more than one flexible electrode sheet 21 and one airfoil sheet 23, for example, when the number of flexible electrode sheets 21 and airfoil sheets 23 is equal, the projection of each airfoil sheet 23 along the direction perpendicular to its own plane can completely accommodate one flexible electrode sheet 21. That is, let the centerline of each airfoil sheet 23 be the centerline of a line segment, and the centerline of each flexible electrode sheet 21 be the centerline of a circular arc, and each line segment centerline can coincide with a circular arc centerline in the same spatial plane.

[0103] This embodiment emphasizes the vertical correspondence between each airfoil 23 and each flexible electrode sheet 21. This serves two purposes: firstly, it reduces the obstruction of the gap 215 by the airfoil 23, ensuring the effective area of ​​the gap 215; secondly, it facilitates control of the electric field lines, ensuring the effectiveness of the electric field.

[0104] 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 device, characterized in that, The implantable electrode device includes: A spherical support, wherein the spherical support is formed by multiple support strips arranged into a hollow spherical structure; A flexible electrode sheet is disposed on the outer surface of the spherical bracket; An airfoil, the airfoil being elongated and strip-shaped, with its non-end portions connected to the spherical support; The spherical support supports the flexible electrode pad for placement in the tumor cavity formed after tumor resection, and the two ends of the wing-shaped plate are used to extend and be secured to the surface of the brain tissue outside the tumor cavity.

2. The implantable electrode device according to claim 1, characterized in that: The support strips of the spherical bracket are warp lines. The head ends of multiple warp lines are fixed at one point to form the top of the spherical bracket, and the tail ends of multiple warp lines are fixed at one point to form the bottom of the spherical bracket. One side of the airfoil is connected to the top of the spherical bracket.

3. The implantable electrode device according to claim 2, characterized in that: The flexible electrode sheet includes at least two electrode units, and the flexible electrode sheet is disposed on the outer surface of the warp line.

4. The implantable electrode device according to claim 3, characterized in that: The number of warp lines is twice the number of flexible electrode sheets. The flexible electrode sheets are bent and wrapped around the outer surfaces of two symmetrical warp lines. The two electrode units of the flexible electrode sheets are arranged opposite each other at intervals.

5. The implantable electrode device according to claim 3 or 4, characterized in that: The width of the flexible electrode sheet is greater than the width of the warp line, so that the flexible electrode sheet covers the warp line.

6. The implantable electrode device according to claim 1, characterized in that: The number of flexible electrode sheets is at least two, and a gap is formed between two adjacent flexible electrode sheets that can communicate with the interior of the spherical support.

7. The implantable electrode device according to claim 6, characterized in that: Sensors are suspended inside the spherical support to measure the viscosity and / or density of cerebrospinal fluid.

8. The implantable electrode device according to claim 1, characterized in that: The number of airfoils is at least two, and the two or more airfoils are arranged in an intersecting manner. The spherical bracket is connected to the intersecting part of the two or more airfoils.

9. The implantable electrode device according to claim 3, characterized in that: The flexible electrode sheet includes a flexible substrate layer, and 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.

10. The implantable electrode device according to claim 9, characterized in that: 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 silicone; the conductive layer is made of at least one of carbon nanotubes, graphene, polythiophene, polyaniline, polypyrrole, gold, silver, or platinum-iridium alloy; and the encapsulation layer is made of at least one of polydimethylsiloxane, polyethylene terephthalate, polyimide, and a composite high dielectric constant material containing inorganic nanoparticles as fillers.

11. The implantable electrode device according to claim 1, characterized in that: The spherical scaffold is made of at least one of medical polyurethane, polylactic acid, polyimide, or polyethylene; the wing-shaped sheet is made of at least one of polydimethylsiloxane, polyethylene terephthalate, polyimide, or polyethylene.

12. The implantable electrode device according to claim 1, characterized in that: The airfoil is a long strip-shaped membrane, and multiple through holes are provided at both ends of the airfoil.

13. An electric field therapy system, characterized in that: include: Electric field generator; and The implantable electrode device according to any one of claims 1 to 12, wherein the implantable electrode device is electrically connected to the electric field generator for generating an alternating electric field by the flexible electrode sheet.

14. The electric field therapy system according to claim 13, characterized in that: The electric field therapy system further includes at least one extratumoral electrode, which is electrically connected to the electric field generator and is used for implantation outside the tumor cavity. The electric field generator is configured to generate an alternating electric field between the flexible electrode sheet and the extratumoral electrode. Preferably, the extratumoral electrode is used for implantation at a location below the skull and above the dura mater.

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