Electrode array for transmitting tumor treatment field and tumor treatment field-based medical device

Abstract

The embodiments of the present invention relate to the technical field of medical instruments, and disclosed is an electrode array for transmitting a tumor treatment field. The electrode array comprises an implantation main body, and the implantation main body comprises a driving assembly and an electrically insulated electrode support. A plurality of electrodes are arranged on the electrode support, the electrode support is provided with a space structure to be filled with or coat in-vivo target tissues, and the plurality of electrodes are spatially arranged to obtain a three-dimensional electric field. The electrode support is connected to a distal end of the driving assembly, and the driving assembly is configured to drive the electrode support to change the space structure and / or pose so as to change the electric field distribution around the in-vivo target tissues. Due to such arrangement, by changing the space structure and / or pose of the electrode support, a physical distance between sub-electrodes on the electrode support can be reduced, or a physical distance between one electrode and other electrodes can be reduced, and therefore the power required by a system is reduced. Further disclosed is a tumor treatment field-based medical device.

Description

Electrode array for delivering tumor treatment field and tumor treatment field medical device Cross-references

[0001] This invention is based on the Chinese patent application with application number "202311761052.6" and application date of December 19, 2023, and claims the priority of the above-mentioned Chinese patent application. The entire content of the above-mentioned Chinese patent application is hereby incorporated into the present invention by introduction. Technical Field

[0002] The embodiments of the present invention relate to the technical field of medical devices, and in particular to an electrode array for delivering a tumor treatment field and a tumor treatment field medical device. Background Art

[0003] Tumor Treating Fields (TTFields) is a technology that uses alternating electric fields to treat cancer. This technology uses an electrode array to generate a low-intensity, medium-frequency (100-300kHz) alternating electric field, which affects the mitosis of cancer cells to disrupt the rapid and uncontrolled cell division of cancer cells, thereby intervening in the proliferation of cancer cells. TTFields technology has been shown to have significant therapeutic effects on some malignant tumors, such as glioblastoma multiforme (GBM) and malignant pleural mesothelioma (MPM). Currently, some TTFields medical devices have been approved by the U.S. Food and Drug Administration (FDA) for newly diagnosed glioblastoma, recurrent glioblastoma and malignant pleural mesothelioma, and have shown promising efficacy and safety in clinical trials.

[0004] Currently used external electrode arrays are located far from the target tumor area, forcing the electric field to penetrate many organs and tissues that are not intended for electric field penetration. This results in significant energy loss and high overall system power. When applying electric field stimulation to tumors in certain anatomical structures, the large-scale electric field applied by the external electrode array may also negatively impact other normal tissues and cells. Furthermore, the placement of the external electrode array is complex, requiring consideration of numerous factors, including uniformity of electric field distribution, effective coverage of the target tissue, penetration depth and direction of the electric field, and the impedance and temperature of surrounding tissues. These factors can impact the effectiveness and safety of the TTFields device. Poor placement of the external electrode array can lead to treatment failure or ineffective results. Furthermore, external electrode arrays present challenges for patients, such as inconvenience in wearing, the need for frequent replacement, and the potential for skin irritation and infection. These issues can impact patient quality of life and lead to low patient compliance. To overcome the shortcomings of external electrode array treatments, implantable TTFields medical devices can be used to treat cancer.

[0005] Because all components of the implantable TTFields medical device are located within the patient's body, the risk of detachment of the external electrode arrays of traditional TTFields devices is avoided. Treatment also does not need to be paused for special occasions such as when the patient is bathing or sleeping, ensuring daily treatment time and improving treatment effectiveness. Furthermore, the implantable TTFields medical device offers better targeting, allowing TTFields to be delivered to anatomical structures that are inaccessible to the external electrode arrays, thus expanding the treatment range. The implantable electrode arrays in the implantable TTFields medical device can be positioned around target tissue in the patient's body (such as a tumor or tumor explantation cavity), further enhancing treatment effectiveness. The implantable electrode arrays reduce the physical distance between the electrode arrays and the target tissue, and can also bypass anatomical structures with high resistivity, such as the skull, significantly reducing the power required to deliver TTFields and reducing the size of the battery in the device. For patients, the implantable TTFields medical device can be hidden within the body, making it highly discreet. It can also avoid issues such as skin irritation, heating, and movement restrictions, thereby improving patient comfort.

[0006] Implantable TTFields medical devices are small and low-power. Generating sufficient field strength and duration of electric field stimulation in low-power medical devices is key to their development. However, the electric fields generated by the electrode arrays in existing implantable TTFields medical devices remain inefficient, hindering further reductions in the power of implantable TTFields medical devices. Therefore, a new electrode array for delivering TTFields is needed in the art to address these technical issues. Summary of the Invention

[0007] The purpose of the embodiments of the present invention is to provide an electrode array for delivering a tumor treatment field and a tumor treatment field medical device, which can reduce the power requirement of the system and improve the treatment effect.

[0008] To solve the above technical problems, the first aspect of the present invention provides an electrode array for delivering a tumor treatment field, comprising:

[0009] An implant body comprises a drive assembly and an electrically insulating electrode holder; a plurality of electrodes, wherein the plurality of electrodes are spaced apart and arranged on the electrode holder; the electrode holder has a spatial structure for filling or covering target tissue in the body, and the plurality of electrodes are spatially arranged to obtain a three-dimensional electric field; the electrode holder is connected to the distal end of the drive assembly, and the drive assembly is used to drive the electrode holder to change its spatial structure and / or posture to change the electric field distribution around the target tissue in the body.

[0010] Optionally, it also includes a fixing part for being set on the torso, and the fixing part is used to support the implant body; the drive assembly includes a central axis movably connected to the fixing part, and the central axis includes an implant segment located in the body; the distal end of the electrode holder is connected to the distal end of the implant segment, and the proximal end of the electrode holder is connected to the proximal end of the implant segment, or one end of the electrode holder is connected to the implant segment and the other end is a free end; the central axis is configured to be driven to move relative to the fixing part to adjust the position of the electrode holder relative to the target tissue in the body.

[0011] Optionally, the central axis also includes an extracorporeal segment located proximal to the implant segment; the drive assembly also includes a positioning member and a positioning groove provided on the fixing member, the positioning member being used to be embedded in the positioning groove and clamped to the extracorporeal segment to fix the position of the central axis.

[0012] Optionally, the fixing member is provided with a driving hole for passing the central axis; the positioning groove extends radially inward from the outer peripheral surface of the fixing member and is connected to the driving hole, and the extension direction of the positioning groove is arranged at an angle to the axial direction of the driving hole; the positioning member has a snap-fitting hole and a snap-fitting notch, and when the positioning member is embedded in the positioning groove, the external segment is accommodated in the snap-fitting hole through the snap-fitting notch, and then the positioning member is snap-fitted to the external segment to fix the external segment.

[0013] Optionally, a positioning portion is provided on the surface of the outer segment, and the positioning portion is used to abut against both axial sides of the positioning member to fix the positioning member and the central axis.

[0014] Optionally, the drive assembly further includes a stop pin, a first stop hole provided on the fixing member, and a second stop hole provided on the positioning member, wherein the first stop hole is used to align with the second stop hole when the central axis is rotated to a desired position, and the stop pin is used to be inserted into the first stop hole and the second stop hole when the first stop hole and the second stop hole are aligned.

[0015] Optionally, it also includes a fixing part fixed on the torso, which is used to support the implant body; the drive assembly includes a central axis movably connected to the fixing part, the central axis includes an implant segment for being set in the body, the distal end of the electrode holder is connected to the distal end of the implant segment, and the proximal end of the electrode holder is axially stationary relative to the fixing part; the central axis is configured to be driven to move axially relative to the fixing part to adjust the axial distance between the distal end of the electrode holder and the proximal end of the electrode holder, thereby adjusting the spatial structure of the electrode holder.

[0016] Optionally, the drive assembly further includes a control wire and a winding shaft, the winding shaft being rotatably disposed on the fixing member, a control through hole being provided in the middle portion of the implant segment at an angle to the axial direction of the central axis, one end of the control wire being relatively stationary relative to the axial direction of the fixing member or being fixed to the proximal end of the implant segment, and the other end extending toward the distal end and, after passing through the control through hole, extending toward the proximal end and winding around the winding shaft, the winding shaft being used to wind or release the control wire to allow the central axis to move axially relative to the fixing member.

[0017] Optionally, the drive assembly further includes an elastic member, a control wire and a winding shaft; the winding shaft is rotatably arranged on the fixing member, and a control through hole is provided in the middle part of the implant segment at an angle to the axial direction of the central axis; one end of the control wire is relatively stationary relative to the axial direction of the fixing member or is fixed to the proximal end of the implant segment, and the other end extends toward the distal end, and after passing through the control through hole, extends toward the proximal end and is wound on the winding shaft, and the winding shaft is used to wind or release the control wire to make the central axis move axially relative to the fixing member; the proximal end of the elastic member remains axially relatively fixed, and the distal end of the elastic member abuts or is fixed to the proximal end of the implant segment, and the elastic member rewinds the control wire on the winding shaft, and the implant segment is compressed when it moves proximally, and drives the implant segment to move distally when the winding shaft releases the control wire.

[0018] Optionally, the drive assembly further includes a moving part fixed to the proximal end of the implant segment, and a driving part rotatably arranged on the fixed part, the driving part is transmission-connected to the moving part, and the driving part is used to drive the moving part to move, thereby driving the central axis to move axially.

[0019] Optionally, a sleeve is fixed to the distal end of the fixing member, the proximal end of the implant segment and the movable member are accommodated in the sleeve, and the proximal end of the electrode holder is connected to the sleeve or the fixing member; the movable member and / or the proximal end of the implant segment are configured to be axially movable relative to the sleeve and circumferentially stationary; the driving member is configured to be circumferentially rotatable relative to the fixing member and axially stationary; the movable member and the driving member are threadedly connected.

[0020] Optionally, the central axis also includes an extracorporeal segment located proximal to the implant segment; the drive assembly also includes a positioning member and a positioning groove provided on the fixing member, the positioning member being used to be embedded in the positioning groove and clamped to the extracorporeal segment to fix the position of the central axis.

[0021] Optionally, the fixing member is provided with a driving hole for the central axis to pass through; the positioning groove extends radially inward from the outer peripheral surface of the fixing member and is connected to the driving hole, and the extension direction of the positioning groove is arranged at an angle to the axial direction of the driving hole; the positioning member has a snap-fit ​​hole and a snap-fit ​​notch, and when the positioning member is embedded in the positioning groove, the external segment is accommodated in the snap-fit ​​hole through the snap-fit ​​notch, and then the positioning member is snap-fitted to the external segment to fix the external segment.

[0022] Optionally, a positioning portion is provided on the surface of the outer segment, and the positioning portion is used to abut against both axial sides of the positioning member to fix the positioning member and the outer segment.

[0023] Optionally, it also includes a fixing part fixed on the torso, which is used to support the implant body; the drive assembly includes a remote control shaft and a proximal control shaft, both of which are axially movable relative to the fixing part, the remote control shaft includes a remote control implant segment for being set in the body, and the proximal control shaft includes a proximal control implant segment for being set in the body; the distal end of the electrode holder is connected to the distal end of the remote control implant segment, and the proximal end of the electrode holder is connected to the distal end of the proximal control implant segment; the electrode holder is configured to: adjust the position of the remote control implant segment and the proximal control implant segment to adjust the spatial structure and / or posture of the electrode holder.

[0024] Optionally, the distal control shaft also includes a distal control external segment located at the proximal end of the distal control implant segment, and the proximal control shaft also includes a proximal control external segment located at the proximal end of the proximal control implant segment; the drive assembly also includes a positioning member and a positioning groove provided on the fixing member; the positioning member is used to be embedded in the positioning groove and simultaneously clamp the distal control external segment and the proximal control external segment to fix the positions of the distal control shaft and the proximal control shaft.

[0025] Optionally, the outer segment of the remote control body is provided with a first sub-positioning portion, and the outer segment of the near control body is provided with a second sub-positioning portion, and the first sub-positioning portion and the second sub-positioning portion are used to simultaneously abut against the axial sides of the positioning member to fix the outer segment of the remote control body and the outer segment of the near control body.

[0026] Optionally, the drive assembly also includes a control wire and a winding shaft, the winding shaft is rotatably set on the fixing part, the remote control implant segment is provided with a control through hole at an angle to the axial direction of the remote control shaft, one end of the control wire is relatively stationary relative to the axial direction of the fixing part or is fixed to the proximal end of the remote control implant segment, the other end of the control wire extends toward the distal end, and after passing through the control through hole, extends toward the proximal end and is wound around the winding shaft; the drive assembly also includes a movable part fixed to the proximal end of the proximal control implant segment, and a driving part rotatably set on the fixing part, the driving part is transmission-connected to the movable part to drive the movable part to drive the proximal control shaft to move axially.

[0027] Optionally, the drive assembly also includes a first movable member fixed at the proximal end of the remote control implant segment, a second movable member fixed at the proximal end of the proximal control implant segment, and a first driving member and a second driving member rotatably arranged on the fixed member; the first driving member is transmission-connected to the first movable member, and the first driving member is used to drive the first movable member to drive the remote control shaft to move axially; the second driving member is transmission-connected to the second movable member, and the second driving member is used to drive the second movable member to drive the proximal control shaft to move axially.

[0028] Optionally, a sleeve is fixed to the distal end of the fixing member, and the remote control implant segment, the proximal end of the proximal control implant segment, the first movable member and the second movable member are accommodated in the sleeve; the first movable member and / or the proximal end of the remote control implant segment are configured to be axially movable relative to the sleeve and circumferentially stationary; the second movable member and / or the proximal end of the proximal control implant segment are configured to be axially movable relative to the sleeve and circumferentially stationary; the first driving member and the second driving member are configured to be circumferentially rotatable relative to the fixing member and axially stationary; the first driving member and the first movable member are threadedly connected; the second driving member and the second movable member are threadedly connected.

[0029] Optionally, the drive assembly includes a central axis, a remote control ring and a near control ring, the central axis includes an implantation segment located in the body, the remote control ring and the near control ring are movably arranged on the implantation segment, the distal end of the electrode holder is connected to the remote control ring, and the proximal end of the electrode holder is connected to the near control ring; the electrode holder is configured to: drive the remote control ring and / or the near control ring to move axially to adjust the position of the distal end of the electrode holder and / or the proximal end of the electrode holder, and change the spatial structure and / or posture of the electrode holder.

[0030] Optionally, the implant segment has a sliding hole passing through in a radial direction, and the sliding hole extends axially along the implant segment, the proximal control ring includes an external first ring, and a first cross bar radially arranged along the first ring, and the distal control ring includes an external second ring, and a second cross bar radially arranged along the second ring; the drive assembly includes a first control wire and a second control wire; the first ring and the second ring are respectively sleeved on the outside of the implant segment, the first cross bar and the second cross bar respectively pass through the sliding hole, the second control wire extends from the sliding hole and is connected to the first cross bar, so that the proximal control ring moves axially along the implant segment, and the first control wire extends from the sliding hole and is connected to the second cross bar, so that the distal control ring moves axially along the implant segment.

[0031] Optionally, the electrode bracket includes multiple segments, and at least some of the segments include a metal layer and an insulating layer arranged outside the metal layer in a radial direction, and at least some of the insulating layers are arranged discontinuously in the axial direction to form an insulating gap, and the metal layer exposed in the insulating gap serves as the electrode.

[0032] Optionally, an electrode sheet is further included, and the electrode sheet is electrically connected to the exposed metal layer to serve as the electrode.

[0033] Optionally, the electrode is provided on the central axis.

[0034] Optionally, the electrodes are provided on the distal control shaft and / or the proximal control shaft.

[0035] Optionally, the electrode support has a tetrahedral structure, a semi-ellipsoidal structure, a spiral cone structure or an octahedral structure.

[0036] Optionally, the electrode holder has an ellipsoidal structure, a spiral spindle structure or a bidirectional helical structure.

[0037] Optionally, two control channels are provided on the tube wall of the implant segment between the control through hole and the proximal end of the implant segment for the control wire to pass through.

[0038] The second aspect of the present invention provides a tumor treatment field medical device, comprising: a stimulator, an electrode wire and an electrode array of any of the above items, wherein the stimulator is electrically connected to the electrodes of the electrode array via the electrode wire, and the stimulator is used to provide electrical stimulation to the electrodes.

[0039] Optionally, a counter electrode is further included, which is arranged around the electrode array and is used to form a three-dimensional electric field with the electrodes on the electrode array.

[0040] Optionally, a conductive gel is provided in the space formed by the electrode support of the electrode array, or in the space between the electrode support of the electrode array and the pair of electrodes.

[0041] Compared with the related art, the embodiments of the present invention provide an electrically insulating electrode holder, on which a plurality of electrodes are provided; the electrode holder can fill the target tissue in the body (such as a tumor removal cavity) or cover the target tissue in the body (such as the tumor itself), and support the plurality of electrodes so that they are spatially distributed to obtain a three-dimensional electric field; the spatial structure and / or position of the electrode holder are driven to change by a driving component, thereby changing the electric field distribution around the target tissue in the body. With such a configuration, an electric field that can cover or fill the target tissue in the body can be formed by the spatial arrangement of the electrodes, thereby increasing the area of ​​action on the target tissue in the body and reducing the required power consumption; the spatial structure and / or position of the electrode holder can be changed to change the position of the electrode relative to the target tissue in the body, thereby reducing the power required by the system while maintaining the treatment effect. On the other hand, the electrode holder can be driven to change by a driving component to optimize the spatial arrangement of the electrodes, change the intensity and distribution of the electric field, and optimize the treatment effect of the tumor treatment field while keeping the power consumption of the medical device unchanged. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] One or more embodiments are exemplarily illustrated by pictures in the corresponding drawings. These exemplifications do not constitute limitations on the embodiments. Elements with the same reference numerals in the drawings are represented as similar elements. Unless otherwise stated, the figures in the drawings do not constitute proportional limitations.

[0043] FIG1 is a schematic diagram of the three-dimensional structure of an electrode array according to a first embodiment of the present invention;

[0044] FIG2 is a schematic diagram of the three-dimensional structure of another electrode array according to the first embodiment of the present invention;

[0045] FIG3 is a side view schematic diagram of another electrode array according to the first embodiment of the present invention;

[0046] FIG4 is a side view schematic diagram of another electrode array according to the first embodiment of the present invention;

[0047] FIG5 is a schematic diagram of the three-dimensional structure of another electrode array according to the first embodiment of the present invention;

[0048] FIG6 is a schematic diagram of the three-dimensional structure of another electrode array according to the first embodiment of the present invention;

[0049] FIG7 is a schematic diagram of the three-dimensional structure of another electrode array according to the first embodiment of the present invention;

[0050] FIG8 is a schematic diagram of the three-dimensional structure of another electrode array according to the first embodiment of the present invention;

[0051] FIG9 is a schematic diagram of the three-dimensional structure of the electrode holder in FIG8 after the spatial structure is changed;

[0052] FIG10 is an exploded schematic diagram of an electrode support array structure according to a second embodiment of the present invention;

[0053] FIG11 is an enlarged view of the S1 region in FIG10 ;

[0054] FIG12 is a schematic diagram of the three-dimensional structure of an electrode array according to the third embodiment of the present invention;

[0055] FIG13 is an enlarged schematic diagram of the S2 region in FIG12 ;

[0056] FIG14 is a cross-sectional schematic diagram of an electrode array according to a fourth embodiment of the present invention;

[0057] FIG15 is an enlarged schematic diagram of the S3 region in FIG14 ;

[0058] FIG16 is a cross-sectional schematic diagram of another electrode array according to the fourth embodiment of the present invention;

[0059] FIG17 is a schematic diagram of the three-dimensional structure of an electrode array according to a fifth embodiment of the present invention;

[0060] FIG18 is a schematic cross-sectional view of a portion of the proximal end of the electrode array shown in FIG17 ;

[0061] FIG19 is an enlarged schematic diagram of the S4 region in FIG18 ;

[0062] FIG20 is an exploded schematic diagram of the structure of the electrode array shown in FIG17;

[0063] FIG21 is a schematic diagram of the electrode array shown in FIG17 viewed from the proximal end to the distal end;

[0064] FIG22 is a cross-sectional schematic diagram of an electrode array according to a sixth embodiment of the present invention;

[0065] FIG23 is a partial enlarged schematic diagram of the proximal end of the electrode array in FIG22;

[0066] FIG24 is a cross-sectional schematic diagram of an electrode array according to a seventh embodiment of the present invention;

[0067] FIG25 is an enlarged schematic diagram of the S5 region in FIG24 ;

[0068] FIG26 is a schematic cross-sectional view taken along line AA' in FIG24;

[0069] FIG27 is a side view schematic diagram of an electrode array according to an eighth embodiment of the present invention;

[0070] FIG28 is a cross-sectional view of an alternative embodiment of the eighth embodiment of the present invention, in which a proximal control ring is sleeved on the central axis;

[0071] FIG29 is a schematic diagram of a tumor treatment field medical device according to the ninth embodiment of the present invention after being implanted into a human body. DETAILED DESCRIPTION

[0072] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more apparent, the embodiments of the present invention will be described in detail below with reference to the accompanying drawings. However, those skilled in the art will appreciate that many technical details are provided in the embodiments of the present invention to help readers better understand the present application. However, even without these technical details and the various variations and modifications based on the following embodiments, the technical solutions claimed in the present application can still be implemented.

[0073] In the embodiments of the present invention, terms such as "upper," "lower," "left," "right," "front," "back," "top," "bottom," "inner," "outer," "center," "vertical," "horizontal," "transverse," and "longitudinal" to indicate directions or positions are based on the directions or positions shown in the accompanying drawings. These terms are primarily intended to better describe the present invention and its embodiments and are not intended to limit the devices, elements, or components indicated to having a specific direction, or to being constructed or operated in a specific direction.

[0074] Furthermore, some of the above terms may be used to express other meanings besides indicating a position or location. For example, the term "on" may also be used to indicate a dependency or connection in certain circumstances. Those skilled in the art will understand the specific meanings of these terms in the present invention based on the specific circumstances.

[0075] Furthermore, the terms "installed," "set," "provided with," "opened," "connected," and "connected" should be interpreted broadly. For example, they can refer to fixed connections, removable connections, or integral structures; mechanical connections or electrical connections; direct connections or indirect connections through an intermediary; or internal communication between two devices, elements, or components. Those skilled in the art will understand the specific meanings of these terms in the present invention based on specific circumstances.

[0076] In addition, the terms "first," "second," etc., are primarily used to distinguish different devices, components, parts, parts, elements, or components (which may or may not be the same in type and configuration), and are not intended to indicate or imply the relative importance or quantity of the devices, components, or components indicated. Unless otherwise specified, "plurality" means two or more.

[0077] In the present invention, "proximal" and "proximal side" refer to the end of the electrode array and various components, parts, and parts of the medical device that is close to the operator and away from the patient, and "distal" and "distal side" refer to the end of the electrode array and various components, parts, and parts of the medical device that is away from the operator and close to the patient. "Axial" refers to the direction from the distal end to the proximal end or from the proximal end to the distal end, that is, the axial direction is not unidirectional. "Circumferential" refers to the direction of rotation with a straight line extending along the axial direction as the axis, and similarly, the circumferential direction is not unidirectional. Patients receiving this treatment can be any animal in need, including primates, especially humans, and other mammals such as cats, dogs, horses, cows, pigs, and sheep.

[0078] Tumor Treatment Fields (TTFields) technology is a method of treating cancer using alternating electric fields, and has been shown to have significant therapeutic effects on some malignant tumors. Traditional TTFields treatment devices use extracorporeal electrode arrays to achieve treatment, but extracorporeal electrode arrays have many defects such as inconvenience in use and poor treatment effects. In response to the defects of extracorporeal electrode arrays, some companies have proposed the use of implantable TTFields medical devices for treatment. For example, Chinese patent documents CN111263656B, CN113766949A and CN113727753A propose some medical devices for treating cancerous tumors. The electrode arrays disclosed in these patent documents are basically linear or planar, and the electric field formed by the positive and negative electrodes cannot effectively cover the entire tumor. The stimulator needs to provide a large current to increase the electric field strength, which is contrary to the low power consumption requirement of implantable medical devices. In addition, the shape of the electrode array disclosed in the patent literature is difficult to change after implantation. If the electric field shape is not set properly during the preoperative evaluation, or there are significant changes in the tissues in the body, or there is unexpected movement of the electrode array after implantation, these will greatly reduce the treatment effect and make effective adjustments impossible.

[0079] In order to solve one or more of the above technical problems, an embodiment of the present invention provides an electrode array for delivering tumor treatment fields, comprising: an implant body, including a drive component and an electrically insulating electrode holder; a plurality of electrodes, wherein the plurality of electrodes are arranged on the electrode holder; the electrode holder has a spatial structure to fill or cover the target tissue in the body, and the plurality of electrodes are spatially arranged to obtain a three-dimensional electric field; the distal end of the electrode holder is connected to the distal end of the drive component, and the drive component is used to drive the electrode holder to change the spatial structure and / or posture to change the electric field distribution around the target tissue in the body.

[0080] An embodiment of the present invention further provides a tumor treatment field medical device, comprising: a stimulator, an electrode wire and the above-mentioned electrode array, wherein the stimulator is electrically connected to the electrodes of the electrode array via the electrode wire, and the stimulator is used to provide electrical stimulation to the electrodes.

[0081] Compared with the related art, the electrode array for delivering tumor treatment fields provided by the embodiment of the present invention is provided with an electrically insulating electrode holder, on which a plurality of electrodes are provided; the electrode holder can fill the target tissue in the body (such as the tumor removal cavity) or cover the target tissue in the body (such as the tumor itself), and support the plurality of electrodes so that they are three-dimensionally distributed to obtain a three-dimensional electric field; the spatial structure and / or posture of the electrode holder are driven to change by the driving component, thereby changing the electric field distribution around the target tissue in the body. With such a configuration, an electric field that can cover or fill the target tissue in the body can be formed by the spatial arrangement of the electrodes, thereby increasing the area of ​​action on the target tissue in the body and reducing the required power consumption; by changing the spatial structure and / or posture of the electrode holder, the power required by the system can be reduced while maintaining the treatment effect. On the other hand, by driving the electrode holder to change by the driving component to optimize the spatial arrangement of the electrodes and change the intensity and distribution of the electric field, the treatment effect of the tumor treatment field can be optimized while the power consumption of the medical device remains unchanged.

[0082] The following is a detailed description of the implementation details of the electrode array according to the embodiment of the present invention. The following content is only provided for ease of understanding and is not necessary for implementing the present solution.

[0083] Referring to Figures 1 to 10 , a first embodiment of the present invention provides an electrode array 100 for delivering a tumor treatment field, comprising: an implant body 110 including a drive assembly and an electrically insulating electrode holder 112; a plurality of electrodes 120 disposed on the electrode holder 112; the electrode holder 112 having a spatial structure to fill or encapsulate target tissue within the body, and spatially arranging the plurality of electrodes 120 to generate a three-dimensional electric field; the electrode holder 112 being connected to the distal end of the drive assembly, which is configured to drive the electrode holder 112 to change its spatial structure and / or posture to alter the electric field distribution at the target tissue within the body. "Pose" here is short for position and posture.

[0084] With such a configuration, an electric field that can cover or fill the target tissue in the body can be formed through the spatial arrangement of the electrodes, thereby increasing the area of ​​action on the target tissue in the body and reducing the required power consumption; the spatial structure and / or posture of the electrode holder 112 can be changed, thereby reducing the power required by the medical system while maintaining the treatment effect; on the other hand, the electrode holder 112 can be driven by the driving component to change, so as to optimize the spatial arrangement of the electrodes and change the intensity and distribution of the electric field, thereby optimizing the treatment effect of the tumor treatment field while keeping the power consumption of the medical device unchanged.

[0085] It is understandable that the target tissue in the body in this embodiment can be the tumor itself or the tumor removal cavity formed after surgical removal of the tumor. If the target tissue in the body is the tumor itself, the electrode holder 112 with a three-dimensional spatial structure can be configured to cover the tumor. If the cancerous part of the body tissue is removed by surgical resection or the like, and a tumor removal cavity is formed, the electrode holder 112 with a three-dimensional spatial structure can be configured to fill the tumor removal cavity. The multiple electrodes 120 are arranged on the electrode holder 112 to form a spatial three-dimensional distribution, and the stimulator outputs electrical stimulation to the electrode array 100 to form a three-dimensional electric field that wraps or fills the target tissue in the body between the multiple electrodes 120, or to form a three-dimensional electric field between the electrodes 120 and the counter electrodes arranged on the inner or outer side of the electrode array 100 to interfere with the mitosis of cancer cells, thereby achieving the treatment of cancer.

[0086] In one example, a conductive gel can be injected into the space formed by the electrode holder 112 or the space between the electrode holder 112 and the counter electrode to increase the conductivity of the target action area, further reduce the impedance between the electrodes 120 and the electrodes 120 and / or between the electrodes 120 and the counter electrode, and reduce the power requirements of the medical device.

[0087] In one example, the electrode holder 112 includes a connecting end and a free end, the connecting end is used to connect to the drive assembly, and the change of posture is achieved through the drive assembly. In one example, the electrode holder 112 includes two connecting ends, at least one of which is used to connect to the drive assembly, and the change of posture and / or the change of spatial structure is achieved through the drive assembly. For example, the drive assembly includes a movable central axis 111, and the two connecting ends of the electrode holder 112 are both arranged on the central axis 111, and the posture change of the electrode holder 112 is achieved through the movement of the central axis 111. In particular, if the structure of the electrode holder 112 is stable and not prone to spatial structural deformation, the posture change of the electrode holder 112 can only be achieved through the movement of the central axis 111 (for example, axial movement and / or rotation around the axial direction). If the spatial structure of the electrode holder 112 is changeable, for example, the structure itself is easily changeable or the segment material is flexible, the distal connection end of the electrode holder 112 is disposed on the central axis 111, and the proximal connection end of the electrode holder 112 is configured to be fixed relative to the axial direction. The spatial structure of the electrode holder 112 can be changed by driving the drive assembly, such as the central axis 111. Furthermore, if the spatial structure of the electrode holder 112 is changeable, and the drive assembly includes a movable distal control shaft 1114 and a proximal control shaft 1115, the two connection ends of the electrode holder 112 are respectively disposed on the distal control shaft 1114 and the proximal control shaft 1115. The movement of the distal control shaft 1114 and the proximal control shaft 1115 can change the position and spatial structure of the electrode holder 112.

[0088] Referring to Figure 1 , the electrode holder 112 has an octahedral structure, comprising twelve rigid segments 1121. These twelve segments 1121 form an octahedral structure, with the two vertices of the octahedral structure forming the two connecting ends of the electrode holder 112. In this embodiment, the drive assembly includes a central axis 111, which includes an implantable segment 111a located within the patient's body. In another example, the central axis 111 also includes an external segment 111b located outside the patient's body. The two vertices of the octahedral structure are respectively fixed to the distal and proximal ends of the implantable segment 111a of the central axis 111, forming a closed spatial structure. The distal connecting end of the electrode holder 112 is fixed to the distal end of the implantable segment 111a, and the proximal connecting end of the electrode holder 112 is fixed to the proximal end of the implantable segment 111a. Furthermore, because the segments 1121 are made of a rigid material, the electrode holder 112 has good stability along the axial direction of the central axis 111. The driving component can drive the electrode holder 112 to change its posture.

[0089] The electrode array 100 also includes a fixing member 130, which is disposed on the patient's body surface and supports the implant body 110. The central axis 111 is movably connected to the fixing member 130. In one example, the central axis 111 passes through the fixing member 130 from outside the patient's body and into the patient's body, forming the aforementioned implant segment 111a and a possible external segment 111b. The implant segment 111a passes through the electrode holder 112. The electrode holder 112 can be sleeved over the implant segment 111a. In another example, the central axis 111 passes through the fixing member 130 from outside the patient's body and into the patient's body, forming only the aforementioned implant segment 111a. Therefore, the central axis 111 only has the implant segment 111a. Because the central axis 111 can move and / or rotate relative to the fixing member 130, it can drive the electrode holder 112 to move and / or rotate, thereby achieving a change in the position of the electrode holder 112 relative to the target tissue in the body.

[0090] In this embodiment, the electrodes 120 can be arranged at any position on the segments 1121, or at different positions depending on the characteristics and location of the tumor. In one example, the electrodes 120 are disposed on at least some of the segments 1121, and each segment 1121 having electrodes 120 disposed thereon can have one or more electrodes 120 disposed thereon. In another example, the electrodes 120 are disposed on the central axis 111.

[0091] In this embodiment, the electrodes 120 may be capacitively coupled or resistively coupled. Of course, the type of electrodes 120, as well as the shape, size, and material of the electrodes 120, may also be selected based on the characteristics and location of the tumor.

[0092] In this embodiment, the segment 1121 includes a metal layer and an insulating layer arranged outside the metal layer in the radial direction. For example, the segment 1121 is prepared from a metal wire coated with an insulating layer. For example, the metal wire is a nickel-titanium alloy wire. In one example, at least part of the insulating layer is arranged discontinuously in the axial direction. At the position where the electrode 120 is preset on the segment 1121, the insulating layer is removed to form an insulating gap, and the exposed metal wire is used as the electrode 120. In one example, an electrode sheet is attached to the exposed metal layer to serve as an electrode. The material of the electrode sheet can be platinum or its alloy, iridium or its alloy. In one example, the outer surface of the electrode sheet is also provided with a chemical coating (such as titanium nitride TiN, iridium oxide IrO2) to increase its microscopic surface area. The electrode sheet can be electrically connected to the exposed metal wire of the segment 1121 by welding, riveting, binding, etc. For example, the cross-section of the electrode sheet is O-shaped, and the electrode sheet is placed on the bare metal wire, and then the electrode sheet is electrically connected to the bare metal wire by pressing and gripping. The cross-section of the electrode sheet can also be other closed shapes, such as an ellipse. The cross-section of the electrode sheet can also be a semi-closed shape, such as a C-shape. For another example, the electrode sheet is a sheet-like structure, and the electrode sheet is welded to the bare metal wire to achieve electrical connection between the two. In other examples, the electrode sheet is claw-shaped, and is electrically connected to the metal wire after piercing the insulating layer. In other examples, the segment 1121 can be made of a polymer material. The electrode sheet is used alone as the electrode 120, fixed on the segment 1121, and the metal wire is placed on the segment 1121 by embedding, attaching, etc. to connect the electrode sheet to the stimulator.

[0093] Please refer to Figure 2. The electrode holder 112 has a tetrahedral structure, that is, the electrode holder 112 includes six rigid segments 1121, and the six segments 1121 form a tetrahedral structure, wherein a vertex of the tetrahedral structure forms the connecting end of the electrode holder 112, and the bottom surface corresponding to the vertex forms the free end of the electrode holder 112. The vertex of the tetrahedral structure is fixed to the distal end of the implant segment 111a of the central axis 111, and the bottom surface corresponding to the vertex is located at the proximal end of the implant segment 111a. Correspondingly, the connecting end of the electrode holder 112 is fixed to the distal end of the implant segment 111a of the central axis 111, and the free end of the electrode holder 112 is located at the proximal end of the implant segment 111a. The electrode holder 112 has a semi-enclosed spatial structure. Due to the stability of the tetrahedral structure, the electrode holder 112 has good stability. The driving component, such as the central axis 111, can drive the posture change of the electrode holder 112. The electrodes 120 are provided on at least part of the segments 1121 , and the details are similar to those described above and will not be repeated herein.

[0094] Referring to FIG3 , the electrode holder 112 has an ellipsoidal structure, with two connection ends formed at the ends in the long axis direction. The distal end of the segment 1121 forms the distal connection end of the electrode holder 112, and the proximal end of the segment 1121 forms the proximal connection end of the electrode holder 112. The difference from the above embodiment is that the segment 1121 includes multiple rotatably connected sub-segments. For example, the segment 1121 includes a distal terminal segment 1121a, a middle sub-segment, and a proximal terminal segment 1121b. The distal end of the distal terminal segment 1121a is rotatably connected to the distal end of the implant segment 111a of the central axis 111, the proximal end of the distal terminal segment 1121a is rotatably connected to the distal end of the middle sub-segment, and the distal end of the proximal terminal segment 1121b is rotatably connected to the proximal end of the middle sub-segment. The proximal end of the proximal terminal segment 1121b is configured to be rotatable relative to the fixing member 130 and movable relative to the central axis 111. For example, the proximal terminal segment 1121b is rotatable relative to the fixing member 130, while the axial position relative to the fixing member 130 remains unchanged. Exemplarily, the proximal terminal segment 1121b is rotatably connected to the fixing member 130. In this way, the segment 1121, the fixing member 130 and the central axis 111 constitute a motion mechanism similar to a connecting rod slider mechanism. Through the driving component, such as the central axis 111, the distal end of the distal terminal segment 1121a is driven to move relative to the proximal end of the proximal terminal segment 1121b, so that the distance between the distal end of the distal terminal segment 1121a and the proximal end of the proximal terminal segment 1121b changes, and at the same time, the angle between the distal terminal segment 1121a, the middle sub-segment and the proximal terminal segment 1121b changes, thereby changing the spatial structure of the electrode holder 112. The change in the spatial structure of the electrode holder 112 causes the spatial position of the electrode 120 provided on the electrode holder 112 to change, thereby changing the electric field distribution at the target tissue in the body. Alternatively, the central axis includes a plurality of mutually movable components, such as the distal control axis 1114 and the proximal control axis 1115 in the following embodiment, and the distal terminal segment 1121a and the proximal terminal segment 1121b are respectively connected to one component. When these two components move relative to each other, the distance between the distal end of the distal terminal segment 1121a and the proximal end of the proximal terminal segment 1121b changes, and at the same time, the angle between the distal terminal segment 1121a, the middle sub-segment and the proximal terminal segment 1121b changes, thereby changing the spatial structure of the electrode holder 112. For another example, the proximal terminal segment 1121b can be rotatably connected to the implant segment 111a of the central axis 111. In this way, the driving component can also drive the electrode holder 112 to move along the axis of the central axis 111 and / or rotate around the axis as a whole, thereby changing the position of the electrode holder 112 relative to the target tissue in the body, thereby changing the electric field distribution at the target tissue in the body.In addition, when the driving assembly includes the distal control shaft 1114 and the proximal control shaft 1115, the proximal end of the electrode holder 112 is movable relative to the central axis 111, and the proximal end of the segment 1121 is movable relative to the central axis 111, which means that the proximal end of the segment 1121 is connected to the proximal control shaft 1115, and the proximal end of the electrode holder 112 and the proximal end of the segment 1121 are movable relative to the distal control shaft 1114.

[0095] In one example, the middle sub-segment includes a first middle sub-segment 1121c and a second middle sub-segment 1121d, and the distal terminal segment 1121a, the first middle sub-segment 1121c, the second middle sub-segment 1121d and the proximal terminal segment 1121b are in the same plane and are rotatably connected in sequence from far to near. The five-link structure formed by the distal terminal segment 1121a, the first middle sub-segment 1121c, the second middle sub-segment 1121d and the proximal terminal segment 1121b simulates the semi-elliptical flexible segment 1121 divided along the major axis of the ellipse. The increase in sub-segments can increase redundant degrees of freedom and increase the convenience of operation. It can be understood that the electrodes 120 are provided on at least some of the sub-segments. The sub-electrodes 120 provided on each sub-segment can be one or more.

[0096] In one example, the distal ends of the plurality of distal terminal segments 1121a are rotatably connected to the distal end of the implant segment 111a of the central shaft 111 via a hinge 1121e, and the proximal ends of the plurality of proximal terminal segments 1121b are rotatably disposed on a fixing member 130 via the hinge 1121e. When the implant segment of the central shaft 111 moves, the fixing member 130 does not move along with the central shaft 111, but the distal ends of the distal terminal segments 1121a move relative to the fixing member 130 driven by the central shaft 111, i.e., the distal ends of the distal terminal segments 1121a and the proximal ends of the proximal terminal segments 1121b move relative to each other, causing the spatial structure of the electrode holder 112 to change.

[0097] In another example, when the middle sub-segment is not provided, the proximal end of the distal terminal segment 1121a and the distal end of the proximal terminal segment 1121b are rotationally connected. At this time, the electrode holder 112 has a structure similar to an octahedron. The distal terminal segment 1121a, the proximal terminal segment 1121b, the fixing member 130 and the central axis 111 constitute a motion mechanism similar to a connecting rod slider mechanism. When the central axis 111 moves axially, the distal terminal segment 1121a and the proximal terminal segment 1121b both rotate, and the angle between the distal terminal segment 1121a and the proximal terminal segment 1121b changes, so that the spatial structure of the electrode holder 112 changes.

[0098] Referring to FIG. 4 , the electrode holder 112 also has an ellipsoidal structure, which differs from the above-mentioned example in that it includes a plurality of flexible segments 1121. The distal end of each segment 1121 is fixed to the distal end of the implantation segment 111a of the central axis 111, and the proximal end of each segment 1121 extends toward the proximal end of the central axis 111 and is axially stationary relative to the fixing member 130. In one example, a sleeve 133 is provided at the distal end of the fixing member 130, and the proximal end of each segment 1121 is fixed to the sleeve 133. The shape of each segment 1121 is a semi-ellipse divided along the major axis of the ellipse. The plurality of segments 1121 are arranged circumferentially around the central axis 111 and enclose the electrode holder 112. At least one electrode 120 is provided on each segment 1121. In one example, a plurality of electrodes 120 are provided at intervals on each segment 1121. The central axis 111 also includes an extracorporeal segment 111b located outside the body. Since the multiple segments 1121 are bendable, the spatial structure of the electrode holder 112 can be changed by driving the assembly, for example, by moving the extracorporeal segment 111b of the central axis 111, so as to change the distribution of the three-dimensional electrode array. Compared with the above embodiment, the use of flexible segments that can bend and deform themselves can eliminate the need for a multi-link structure, thereby reducing manufacturing difficulty. In an alternative example, the proximal end of the electrode holder 112 can also be fixed to the implantation segment 111a of the central axis 111. The driving assembly can drive the electrode holder 112 as a whole to move along the axis of the central axis 111 and / or rotate around the axis, thereby changing the position of the electrode holder 112 relative to the target tissue in the body, thereby changing the electric field distribution at the target tissue in the body.

[0099] Please refer to Figure 5, the segment 1121 is still made of flexible material. The difference from the above example is that the electrode holder 112 is a semi-ellipsoidal structure, that is, a semi-ellipsoidal structure cut along the short axis of the ellipsoid. The electrode holder 112 with a semi-ellipsoidal structure correspondingly has only one connecting end and one free end. The electrode holder 112 includes a plurality of quarter-elliptical segments 1121 and a constraint ring 1122. The distal end of the segment 1121 is fixed to the distal end of the implant segment 111a of the central axis 111, and the proximal end is fixed to the constraint ring 1122. The plurality of segments 1121 are arranged around the axis of the central axis 111 to form a semi-closed three-dimensional structure. The distal end of the segment 1121 forms the above-mentioned connecting end, and the proximal end of the segment 1121 and the constraint ring 1122 form the above-mentioned free end. At this time, when the central axis 111 is moved and / or rotated relative to the fixing member 130, the electrode holder 112 of the semi-ellipsoidal structure follows and moves and / or rotates, so that the electrode 120 on the semi-ellipsoidal structure electrode holder 112 changes its posture relative to the target tissue in the body, thereby changing the electric field distribution around the target tissue in the body.

[0100] Please refer to Figure 6, the segment 1121 is still made of flexible material. The difference from the above example is that the electrode holder 112 has a spiral cone structure. One end of the segment 1121 is fixed to the distal end of the implant segment 111a of the central axis 111, and the other end of the segment 1121 spirally extends around the axis of the central axis 111, and the radius continues to increase, forming a spiral cone structure. Therefore, the electrode holder 112 has a semi-closed space structure. At this time, when the central axis 111 is moved and / or rotated relative to the fixing member 130, the electrode holder 112 with a spiral cone structure follows and moves and / or rotates, so that the electrode on the electrode holder 112 with a spiral cone structure changes its posture relative to the target tissue in the body, thereby changing the electric field distribution around the target tissue in the body.

[0101] Please refer to Figure 7. The electrode holder 112 is a spiral spindle structure, that is, a double spiral cone-shaped structure, which can form a closed space. The electrode holder 112 has two connecting ends, namely a distal connecting end and a proximal connecting end. In one example, the distal end of the electrode holder 112, such as the distal connecting end, is fixed to the distal end of the implant segment 111a of the central axis 111, and the proximal end of the electrode holder 112, such as the proximal connecting end, is configured to be axially stationary relative to the fixing member. When the central axis 111 moves toward the proximal end, the distal end of the electrode holder 112 with the spiral spindle structure moves relative to the proximal end, and the electrode holder 112 with the spiral spindle structure shrinks and deforms in the axial direction, and the spatial distribution of the electrodes on the electrode holder 112 changes, thereby changing the electric field distribution around the target tissue in the body. In another example, the proximal end of the electrode holder 112, such as the proximal connecting end, is fixed to the proximal end of the implantation segment 111a of the central axis 111, so that the movement of the central axis 111 produces a posture change of the electrode holder similar to that shown in FIG6.

[0102] Referring to Figures 8 and 9 , the segments 1121 include two types: a first segment and a second segment. Both segments are in the shape of three-dimensional helices and are similar, differing in that they have opposite helical directions. The first and second segments interweave to form an electrode holder in the shape of a bidirectional helix with two connecting ends. As shown in Figure 8 , both segments are in the shape of spherical helices, thereby forming a spherical electrode holder. Similar to the above example, the distal end of the electrode holder 112, such as the distal connecting end, is connected to the distal end of the implant segment 111a of the central axis 111. The proximal end of the electrode holder 112, such as the proximal connecting end, remains axially stationary relative to the fixture 130. At this point, by relative movement of the distal and proximal ends of the spherical electrode holder, the radial distances of the first and second segments from the central axis 111 change. For example, by moving the distal and proximal connecting ends of the spherical electrode holder away from each other, the spherical electrode holder can be radially contracted, resulting in the state shown in Figure 9 . By bringing the distal and proximal connecting ends of the spherical electrode holder closer together, the spherical electrode holder can be radially enlarged. Thus, during relative movement of the distal and proximal connecting ends of the electrode holder, the electrode holder 112 can transition between ovoid, spherical, and capsule shapes, adjusting the spatial structure of the electrode holder 112. When the spatial distribution of the electrodes 120 on the electrode holder 112 changes, the electric field distribution around the target tissue in the body is altered.

[0103] In one example, the segment 1121 may be made of an elastic polymer material, such as spandex, etc. In one example, the segment 1121 may be made of a conductive metal material, such as nickel-titanium alloy, etc.

[0104] It is understandable that, in addition to providing a wider range of tumor treatment electric fields, the electrode holder 112 with a variable spatial structure can also reduce the radial size of the electrode holder 112 by adjusting its shape before implantation, thereby facilitating interventional implantation into the body.

[0105] A second embodiment of the present invention provides another electrode array 100. Referring to FIG10 , the electrode array 100 includes an implant body 110, the implant body 110 including a drive assembly and an electrically insulating electrode holder 112; a plurality of electrodes 120, the plurality of electrodes 120 being disposed on the electrode holder 112; the electrode holder 112 having a spatial structure to fill or encapsulate target tissue in the body, and to spatially arrange the plurality of electrodes 120 to obtain a three-dimensional electric field. In this embodiment, the electrode array 100 also includes a fixing member 130 disposed on the body for supporting the implant body 110. The drive assembly includes a central axis 111 that is axially movable relative to the fixing member 130. The central axis 111 includes an implant segment 111a for placement within the body and an external segment 111b for placement outside the body. Obviously, the external segment 111b is disposed proximal to the implant segment 111a.

[0106] In one example, the fixing member 130 is positioned near the implant location of the implant body 110. For example, if the implant body 110 is to be implanted in the brain, the fixing member 130 can be positioned on the patient's skull tissue. The central shaft 111 passes through the fixing member 130 and enters the body. The implant segment 111a is the portion of the central shaft 111 within the patient's body, while the external segment 111b is the portion of the central shaft 111 that remains outside the patient's body. The electrode array 100 also includes a sleeve 133 located at the distal end of the fixing member 130. The sleeve 133 is used to better constrain the movement direction of the central shaft 111 and prevent friction between the central shaft 111 and internal tissue during movement, thereby reducing or preventing damage to the internal tissue. The central shaft 111 is configured to move axially and rotate relative to the fixing member 130. The central shaft 111 can also be configured to move only axially relative to the fixing member 130 as needed. In this embodiment, there is no particular limitation on the method for limiting the rotation of the central shaft 111 relative to the fixing member 130. For example, the cross-section of at least a portion of the central shaft 111 can be configured to be non-circular, and the corresponding holes of the fixing member 130 and the sleeve 133 for passing through the central shaft 111 can also be configured to have corresponding shapes. In this embodiment, the electrode 120 can be disposed on the central shaft 111.

[0107] As shown in the first embodiment, when both ends of the electrode holder 112 are disposed on the implantation segment 111a of the central axis 111, or when only one end of the electrode holder 112 is disposed on the implantation segment 111a of the central axis 111, the implantation segment 111a of the central axis 111 can be axially moved by moving the external segment 111b of the central axis 111, thereby changing the posture of the electrode holder 112. The central axis 111 can also rotate relative to the fixing member 130, and by rotating the external segment 111b of the central axis 111, the implantation segment 111a of the central axis 111 can be rotated, thereby changing the posture of the electrode holder 112 within a larger range. In another example, when the distal end of the electrode holder 112, such as the distal connection end, is disposed on the implantable segment 111a of the central shaft 111, and the proximal end of the electrode holder 112, such as the proximal connection end, remains axially stationary relative to the fixture 130 and sleeve 133, the axial movement of the central shaft 111 can be achieved by moving the external segment 111b of the central shaft 111, thereby adjusting the spatial structure of the electrode holder 112. The proximal end of the electrode holder 112 can remain axially stationary relative to the fixture 130 and sleeve 133 by connecting the proximal end of the electrode holder 112, such as the proximal connection end, to the fixture 130 or sleeve 133. For example, if the electrode holder 112 includes flexible segments, it can be directly fixedly connected to the fixture 130 or sleeve 133. For another example, if the electrode holder 112 includes rigid segments, a rotational connection to the fixture 130 or sleeve 133 is preferably employed.

[0108] In one example, the drive assembly further includes a positioning slot 131 and a positioning member 140 provided on the fixing member 130. The positioning member 140 is used to engage with the outer segment 111b, and the positioning slot 131 is used to allow the positioning member 140 to be embedded in the fixing member 130. In this way, the fixing member 130 and the central axis 111 are fixed together by the positioning member 140 and the positioning slot 131.

[0109] Please also refer to Figure 11. The positioning member 140 is C-shaped or U-shaped, with a snap-in hole 140a and a snap-in notch 140b. The snap-in notch 140b is used to accommodate the outer segment 111b in the snap-in hole 140a. The snap-in hole 140a matches the shape and size of the outer segment 111b of the central shaft 111. When the positioning member 140 is inserted into the positioning groove 131, the outer segment 111b of the central shaft 111 is accommodated in the positioning member 140 through the snap-in notch 140b. The positioning member 140 and the outer segment 111b are snap-fitted together by friction between the wall of the snap-in hole 140a and the outer segment 111b and / or mechanical force generated by the snap-in structure between the two, thereby securing the positioning member 140 and the outer segment 111b. The fixing member 130 is provided with a drive hole for the central shaft 111 to pass through. The positioning groove 131 extends radially inward from the outer peripheral surface of the fixing member 130 and is connected to the drive hole of the fixing member 130. The extension direction of the positioning groove 131 is arranged at an angle to the axial direction of the drive hole. In this embodiment, the positioning groove 131 is configured so that the positioning member 140 is inserted into the positioning groove 131 in a direction perpendicular to the axial direction of the central axis 111. When the central axis 111 extends toward the proximal end, it passes through the drive hole and the positioning groove 131 in sequence. The axial width of the positioning groove 131 is equivalent to the thickness of the positioning member 140, or slightly smaller than the thickness of the positioning member 140. The positioning groove 131 is located in the middle part of the fixing member 130. Accordingly, the fixing member 130 forms blocking portions 132 on both sides of the axial direction, located on both sides of the axial direction of the positioning groove 131, for preventing the positioning member 140 embedded in the positioning groove 131 from moving axially. When the central shaft 111 moves to a predetermined position, the operator can insert the positioning member 140 into the positioning groove 131 so that the positioning member 140 clamps the outer segment 111 b of the central shaft 111 , thereby fixing the axial position of the central shaft 111 .

[0110] In one example, a positioning portion 1111 is provided on the surface of the outer segment 111b of the central shaft 111. The positioning portion 1111 is used to abut against both axial sides of the positioning member 140 to better fix the positioning member 140 to the central shaft 111. The positioning portion 1111 includes a plurality of slots 1111a arranged axially along the outer segment 111b of the central shaft 111. The slots 1111a are formed by the outer surface of the outer segment 111b and an outer protrusion 1111b provided on the outer surface. The diameter of the outer protrusion 1111b is larger than the diameter of the engaging hole 140a, and the axial width of the slots 1111a is equivalent to the thickness of the positioning member 140. When the positioning member 140 engages the outer segment 111b, the inner wall of the engagement hole 140a of the positioning member 140 contacts the outer surface of the outer segment 111b in the engagement groove 1111a, and the two side surfaces of the positioning member 140 abut against the outer protrusion 1111b. In this way, the axial position of the central shaft 111 is better fixed by the cooperation between the positioning member 140 and the positioning portion 1111.

[0111] In one example, when the central axis 111 can rotate relative to the fixing member 130, it is necessary to fix the central axis 111 when the central axis 111 rotates to a desired position. In one example, the contour of the outer surface of the positioning member 140 is no longer circular, but other shapes, such as a polygon, or a rectangle. After the positioning member 140 is embedded in the positioning groove 131, the central axis 111 can be prevented from rotating. In another example, the drive assembly further includes a stop pin, a first stop hole provided on the fixing member 130, and a second stop hole provided on the positioning member 140. The first stop hole is used to align with the second stop hole when the central axis 111 rotates to a desired position, and the stop pin is used to insert into the first stop hole and the second stop hole when the first stop hole and the second stop hole are aligned. In this way, when the central axis 111 rotates to the desired position, the positioning member 140 is embedded in the positioning groove 131, and the first stop hole and the second stop hole are aligned, and the stop pin is inserted to achieve circumferential relative stillness between the fixing member 130 and the central axis 111.

[0112] In other alternative embodiments, the positioning member 140 can be set as a pin, and the positioning groove 131 is replaced by a first positioning hole provided on the fixing member 130 and a plurality of second positioning holes provided on the external segment 111b and forming an angle with the axis of the central axis 111. One of the plurality of second positioning holes is aligned with the first positioning hole, and then the pin is used to pass through the first positioning hole and the second positioning hole to fix the position of the central axis 111.

[0113] The third embodiment of the present invention provides another electrode array 100. The electrode array 100 of this embodiment is similar to the electrode array 100 of the second embodiment, with the main difference being that, in this embodiment, the position of the central axis 111 is no longer fixed by the cooperation of the positioning member 140 and the positioning groove 131. Please refer to Figures 12 and 13 together. The distal end of the central axis 111 of this embodiment passes through the fixing member 130 to form an implantation segment 111a, and there is only the implantation segment 111a. The central axis 111 is configured to allow axial movement and cannot rotate around the axis. The drive assembly also includes a first movable member 1112 fixed to the proximal end of the implantation segment 111a of the central axis 111, and a first drive member 134 rotatably arranged on the fixing member 130. The first drive member 134 is transmission-connected to the first movable member 1112 and is used to drive the first movable member 1112 to move to drive the central axis 111 to move axially.

[0114] In one example, the first driving member 134 is threadedly connected to the first moving member 1112. For example, the first moving member 1112 has an internal thread, and the first driving member 134 has an external thread that matches the internal thread. Exemplarily, the first moving member 1112 is a nut fixed to the proximal end of the central axis 111, and the first driving member 134 is a bolt. The fixing member 130 is provided with a first driving hole 1301, and the bolt is accommodated in the first driving hole 1301, and the threaded portion of the bolt extends into the body. A limiting groove 1341 is provided axially on the bolt, and the first driving hole 1301 is correspondingly provided with a limiting protrusion 1342, and the limiting protrusion 1342 can be accommodated in the limiting groove 1341. In this way, the bolt is configured to allow rotation relative to the fixing member 130 and cannot move axially relative to the fixing member 130. A sleeve 133 is fixed to one side of the distal end of the fixing member 130, and the proximal end of the implant segment 111a and the nut are accommodated in the sleeve 133. The cross-sectional shape of the axial through hole of the sleeve 133 is set to a non-circular shape, such as a waisted circle, an ellipse or a polygon, and the cross-section of at least the proximal part of the implant segment 111a of the nut and / or the central axis 111 is a shape that matches the sleeve 133, and the size is slightly smaller than the size of the cross-section of the sleeve 133. In one example, the cross-sectional shape of the axial through hole of the sleeve 133, the cross-sectional shape of the nut and / or the central axis 111 are set to a polygon, for example, a regular polygon. In this way, the nut and / or the central axis 111 can only move axially and cannot rotate. It should be noted that the "cross-section" here refers to the cross-section perpendicular to the axial direction of the central axis 111.

[0115] In one example, when both connection ends of the electrode holder 112 are disposed on the implantation section 111a of the central shaft 111, the bolt can be rotated to move the nut, thereby driving the central shaft 111 to move, thereby changing the position of the electrode holder 112. In another example, the distal end of the electrode holder 112, such as the distal connection end, is disposed on the distal end of the implantation section 111a of the central shaft 111, and the distal end of the electrode holder 112, such as the proximal connection end, is configured to remain axially stationary relative to the fixing member 130 / sleeve 133. By rotating the bolt, the central shaft 111 can move axially under the action of the threaded fit between the bolt and the nut, thereby driving the distal end of the electrode holder 112 to move, thereby adjusting the spatial structure of the electrode holder 112. The proximal end of the electrode holder 112 can remain axially stationary relative to the fixing member 130, which can be achieved by connecting the proximal end of the electrode holder 112 to the fixing member 130 / sleeve 133. For example, for an electrode holder 112 formed of a flexible segment, its proximal end may be fixed to the fixing member 130 / sleeve 133. For another example, for an electrode holder 112 formed of a rigid segment, its proximal end may be rotatably disposed on the fixing member 130 / sleeve 133.

[0116] In some alternative embodiments, the central shaft 111 is configured as a hollow shaft, and an internal thread that can be connected to the external thread of a bolt is provided inside the central shaft 111. In this way, the weight of the electrode array 100 can be reduced, and the user experience of the patient can be improved.

[0117] In some other alternative embodiments, the proximal portion of the central shaft 111 is provided with an external thread, and the bolt is replaced by a nut with an internal thread, and the nut is configured to be able to only rotate but not move relative to the fixing member 130, so as to drive the central shaft 111 to move axially through the nut.

[0118] A fourth embodiment of the present invention provides another electrode array 100. The electrode array 100 of this embodiment is similar to the electrode array 100 of the second embodiment, with the primary difference being that, in this embodiment, the position of the central axis 111 is no longer fixed by the engagement of the positioning member and the positioning slot 131. Referring to Figures 14 and 15 , the central axis 111 of this embodiment is configured to be axially movable. The drive assembly also includes a control wire 135 and a winding shaft 136. The winding shaft 136 is rotatably arranged on the fixing member 130. The middle part of the implantation segment 111a of the central axis 111 is provided with a control through hole 1113 which is at an angle to the axial direction of the central axis 111. One end of the control wire 135 is axially stationary relative to the fixing member 130 or fixed to the proximal end of the implantation segment 111a of the central axis 111, and the other end extends toward the distal end and passes through the control through hole 1113, and then extends in the opposite direction toward the proximal end and is wound around the winding shaft 136. The winding shaft 136 is used to wind or release the control wire 135 to allow the central axis 111 to move axially relative to the fixing member 130.

[0119] In one example, a sleeve 133 is fixed to the distal end of the fixture 130, and the proximal end of the implant segment 111a of the central shaft 111 is accommodated within the sleeve 133. The central shaft 111 is configured to allow axial movement relative to the sleeve 133. The control through-hole 1113 can be located between the distal and proximal ends of the electrode holder 112. One end of the control wire 135 is fixed to the proximal end of the sleeve 133 or to the fixture 130, ensuring that the control wire 135 remains axially stationary relative to the fixture 130. Alternatively, one end of the control wire 135 can be fixed to the proximal end of the central shaft 111. The other end of the control wire 135 extends distally, passes through the control through-hole 1113, then extends proximally, enters the interior of the sleeve 133, and is wound around the wire winding shaft 136. The wire winding shaft 136 is configured to allow rotation relative to the fixture 130 but cannot move axially relative to the fixture 130. When the winding shaft 136 is rotated to reel in the control wire 135, the control wire 135 pulls the central axis 111 toward the proximal end; when the winding shaft 136 releases the control wire 135, the control wire 135 pushes the central axis 111 toward the distal end. The control wire 135 is a wire with certain bending and compression resistance, which is conducive to pushing the central axis 111 toward the distal end when the winding shaft 136 releases the control wire 135. In one example, between the control through hole 1113 and the proximal end of the implantation section 111a of the central axis 111, two control channels are further provided on the tube wall of the implantation section 111a for the control wire 135 to pass through, so as to prevent the control wire 135 from moving outside the central axis 111 and damaging the tissue in the body.

[0120] In one example, when both ends of the electrode holder 112 are disposed on the implantation segment 111a of the central axis 111, or only one end of the electrode holder 112 is disposed on the implantation segment 111a of the central axis 111, the central axis 111 is axially moved by rotating the wire winding shaft 136 to retract and extend the control wire 135, thereby achieving a change in the posture of the electrode holder 112. In another example, when the distal end of the electrode holder 112, such as the distal connecting end, is disposed on the implantation segment 111a of the central axis 111, and the proximal end of the electrode holder 112, such as the proximal connecting end, remains axially stationary relative to the sleeve 133, the central axis 111 is axially moved by rotating the wire winding shaft 136 to retract and extend the control wire 135, thereby achieving adjustment of the spatial structure of the electrode holder 112. The proximal end of the electrode holder 112 can remain axially stationary relative to the sleeve 133 , which can be achieved by connecting the proximal end of the electrode holder 112 , such as the proximal connecting end, to the sleeve 133 and the fixing member 130 .

[0121] Referring also to FIG. 16 , in some alternative embodiments, an elastic member 133a is disposed proximally within the sleeve 133. The proximal end of the elastic member 133a remains axially fixed, for example, abutting or affixed to the fixing member 130. The proximal end of the implantable segment 111a of the central shaft 111 abuts or affixes to the distal end of the elastic member 133a. Thus, when the winding shaft 136 reels the control wire 135, the central shaft 111 moves proximally, changing the spatial structure of the electrode holder 112 while the implantable segment 111a of the central shaft 111 compresses the elastic member 133a, causing it to store elastic potential energy. When the winding shaft 136 is rotated to release the control wire 135, the elastic member 133a releases this elastic potential energy, pushing the implantable segment 111a of the central shaft 111 distally, thereby changing the spatial structure of the electrode holder 112. At this time, the control wire 135 can be made of a wire with higher softness. In some examples, the elastic member 133a is a compression spring.

[0122] In some of the above-mentioned embodiments, the drive assembly includes a central axis 111, while in some other embodiments, the drive assembly may include a distal control axis and a proximal control axis, both of which may move axially relative to the fixing member 130, and the distal control axis includes a distal control implant segment for being set in the body, and the proximal control axis includes a proximal control implant segment for being set in the body; the distal end of the electrode holder, such as the distal connecting end, is connected to the distal end of the distal control implant segment, and the proximal end of the electrode holder 112, such as the proximal connecting end, is connected to the distal end of the proximal control implant segment; the electrode holder is configured to: adjust the spatial structure and / or posture of the electrode holder 112 by adjusting the positions of the distal control implant segment and the proximal control implant segment.

[0123] A fifth embodiment of the present invention provides another electrode array 100. The electrode array 100 of this embodiment is similar to the electrode array 100 of the second embodiment, and the drive assembly includes a positioning member 140 and a positioning slot 131 provided on the fixing member 130. Referring to Figures 17 to 21, the main difference from the second embodiment is that in this embodiment, instead of the central axis 111, the drive assembly includes a distal control shaft 1114 and a proximal control shaft 1115, and the distal control shaft 1114 and the proximal control shaft 1115 can move axially relative to the fixing member 130. The distal control shaft 1114 and the proximal control shaft 1115 both pass through the fixing member 130. The distal control shaft 1114 and the proximal control shaft 1115 both include an implant segment and an extracorporeal segment, that is, the distal control shaft 1114 includes a distal control implant segment 1114a for being set in the body and a distal control extracorporeal segment 1114b for being set outside the body, and the distal control extracorporeal segment 1114b is set at the proximal end of the distal control implant segment 1114a; the proximal control shaft 1115 includes a proximal control implant segment 1115a for being set in the body and a proximal control extracorporeal segment 1115b for being set outside the body, and the proximal control extracorporeal segment 1115b is set at the proximal end of the proximal control implant segment 1115a. In addition, in this embodiment, the distal end of the electrode holder 112, such as the distal connection end, is connected to the distal end of the remote control implant segment 1114a, and the proximal end of the electrode holder 112, such as the proximal connection end, is connected to the distal end of the proximal control implant segment 1115a; the electrode holder 112 is configured to: adjust the position of the remote control implant segment 1114a of the remote control shaft 1114 and the proximal control implant segment 1115a of the proximal control shaft 1115 through the remote control external segment 1114b and the proximal control external segment 1115b, so as to adjust the posture and / or spatial structure of the electrode holder 112.

[0124] The positioning member 140 is used to be embedded in the positioning groove 131 and simultaneously engage the outer segment 1114b of the remote control body and the outer segment 1115b of the near control body to fix the positions of the remote control axis and the near control axis.

[0125] With this arrangement, the position of the remote control implant segment 1114a and the near control implant segment 1115a can be adjusted by manipulating the proximal control external segment 1115b and the remote control external segment 1114b, thereby changing the position or spatial structure of the electrode holder 112, thereby adjusting the spatial distribution of the multiple electrodes 120 relative to the target tissue in the body to change the electric field distribution around the target tissue in the body. Unlike the second embodiment described above, in which the portion of the electrode holder 112 near the fixing member 130 cannot be adjusted, the position of the electrode holder 112 of the electrode array 100 provided in this embodiment is less restricted, and the proximal end of the electrode holder 112 can move axially, further expanding the adjustment range of the electric field. For example, if the distance between the distal end of the remote control implant segment 1114a and the distal end of the proximal control implant segment 1115a remains unchanged, and the proximal control external segment 1115b and the remote control external segment 1114b are moved simultaneously, the position of the electrode holder 112 can be changed; if the relative position between the remote control implant segment 1114a and the proximal control implant segment 1115a is changed, the spatial structure of the electrode holder 112 can be changed; when the positions of the remote control implant segment 1114a and the proximal control implant segment 1115a, as well as the distance therebetween, the position and spatial structure of the electrode holder 112 can be changed simultaneously. In this embodiment, the electrode 120 can also be provided on the remote control shaft 1114 and / or the proximal control shaft 1115.

[0126] In one example, a sleeve 133 is fixed to one side of the distal end of the fixing member 130, and both the remote control implant section 1114a and the proximal control implant section 1115a pass through the sleeve 133. The remote control shaft 1114 and the proximal control shaft 1115 can be configured as needed to allow axial movement relative to the sleeve 133 and prevent rotation relative to the sleeve 133. For example, as shown in FIG21 , the cross-section of the axial through hole of the sleeve 133 can be a waist circle, and the cross-section shape of at least the proximal end portion of the remote control implant section 1114a and the proximal control implant section 1115a is the same semi-waist circle, and the cross-section shape of at least the proximal end portion of the remote control implant section 1114a and the proximal control implant section 1115a is a waist circle that matches the cross-sectional shape of the sleeve 133. In this way, the remote control shaft 1114 and the near control shaft 1115 can both move axially along the sleeve 133 and cannot rotate relative to the sleeve 133, which can avoid the remote control shaft 1114 and the near control shaft 1115 from accidentally rotating during the process of adjusting the spatial structure of the electrode holder 112, thereby causing the electrode holder 112 to be kinked.

[0127] In other feasible examples, the cross-sectional shape of the axial through hole of the sleeve 133 can also be an ellipse, a square or other polygon. For example, the cross-sectional shape of the sleeve 133 is a polygon. For another example, the cross-sectional shape of the sleeve 133 is a regular polygon with an even number of sides. The cross-sectional shapes of the remote control implant segment 1114a and the proximal control implant segment 1115a are determined according to the cross-sectional shape of the axial through hole. It should be noted that the cross-sectional shape of the sleeve 133, the cross-sectional shape of the remote control shaft 1114 and the cross-sectional shape of the proximal control shaft 1115 are all cross-sectional shapes perpendicular to the axial direction of the sleeve 133.

[0128] In one example, the remote control outer section 1114b is provided with a first sub-positioning portion 1114c, and the proximal control outer section 1115b is provided with a second sub-positioning portion 1115c. The first sub-positioning portion 1114c and the second sub-positioning portion 1115c are configured to simultaneously abut against both axial sides of the positioning member 140 to fix the positions of the remote control shaft 1114 and the proximal control shaft 1115. The first sub-positioning portion 1114c includes a plurality of first retaining grooves provided in the remote control outer section 1114b along the axial direction of the remote control shaft 1114, each of which extends circumferentially along the remote control outer section 1114b. The second sub-positioning portion 1115ca includes a plurality of second retaining grooves provided in the proximal control outer section 1115b along the axial direction of the proximal control shaft 1115, each of which extends circumferentially along the proximal control outer section 1115b. Furthermore, the first slot on the remote control shaft 1114 is arranged on a side away from the near control shaft 1115 , and the second slot on the near control shaft 1115 is arranged on a side away from the remote control shaft 1114 .

[0129] After the posture or spatial structure of the electrode holder 112 is adjusted by the remote control axis 1114 and the near control axis 1115, since the positions of the remote control axis 1114 and the near control axis 1115 need to be fixed at the same time, the positioning member 140 needs to have a larger snap-in hole 140a to accommodate the first sub-positioning portion 1114c of the remote control external segment 1114b and the second sub-positioning portion 1115c of the near control external segment 1115b at the same time.

[0130] The sixth embodiment of the present invention provides an electrode array 100. The electrode array 100 of this embodiment is similar to the electrode array 100 of the fourth embodiment, and the drive assembly includes a control wire 135 and a wire winding shaft 136. The main difference is that, as shown in Figures 22 and 23, in this embodiment, instead of the central axis 111, the drive assembly also includes a distal control shaft 1114 and a proximal control shaft 1115. Accordingly, the distal control shaft 1114 includes a portion for being set in the body, namely, a distal control implant segment 1114a, and the proximal control shaft 1115 includes a portion for being set in the body, namely, a proximal control implant segment 1115a, and the distal end of the distal control implant segment 1114a is further away from the fixing member 130 than the distal end of the proximal control implant segment 1115a. The distal control shaft 1114 and the proximal control shaft 1115 are both axially movable. The distal end of the electrode holder 112, such as the distal connection end, is connected to the distal end of the distal control implant segment 1114a of the distal control shaft 1114. The proximal end of the electrode holder 112, such as the proximal connection end, is connected to the distal end of the proximal control implant segment 1115a of the proximal control shaft 1115. The distal control implant segment 1114a of the distal control shaft 1114 is provided with the control through-hole 1113, which is located distal to the proximal control implant segment 1115a. That is, the control through-hole 1113 is further away from the fixing member 130 than the distal end of the proximal control implant segment 1115a. The winding shaft 136 is rotatably mounted on the fixing member 130. One end of the control wire 135 is axially stationary or fixed to the proximal end of the remote control implant segment 1114a relative to the fixing member 130. The other end of the control wire 135 extends distally and, after passing through the control through hole 1113, extends proximally and is wound around the winding shaft 136. The drive assembly further includes a second movable member 1115d fixed to the proximal end of the proximal control implant segment 1115a of the proximal control shaft 1115, and a second drive member 137 rotatably mounted on the fixing member 130. The second drive member 137 is transmission-connected to the second movable member 1115d to drive the axial movement of the proximal control shaft 1115.

[0131] In one example, a sleeve 133 is fixed to one side of the distal end of the fixing member 130, and the proximal end of the remote control implant segment 1114a and the proximal end of the proximal control implant segment 1115a can be movably accommodated in the sleeve 133 and cannot rotate relative to the sleeve 133. When the wire winding shaft 136 rotates, the control wire 135 pulls the remote control shaft 1114 to move, so that the remote control shaft 1114 drives the distal end of the electrode holder 112 to move, thereby changing the spatial structure of the electrode holder 112. When it is necessary to adjust the position of the proximal end of the electrode holder 112, such as the position of the proximal connecting end, to change the spatial structure of the electrode holder 112, the second moving member 1115d can be driven to move by the second driving member 137 to drive the proximal control shaft 1115 to move.

[0132] In one example, the second moving member 1115d is a nut, the second driving member 137 is a bolt, and the second moving member 1115d is threadedly connected to the second driving member 137. The specific configuration of the second moving member 1115d and the second driving member 137 can refer to the configuration of the first moving member 1112 and the first driving member 134 in the third embodiment, and will not be repeated here.

[0133] The seventh embodiment of the present invention also provides an electrode array 100. The electrode array 100 of this embodiment is similar to the electrode array 100 of the sixth embodiment. The main difference is that, as shown in Figures 24 to 26, in this embodiment, the position of the remote control shaft 1114 is no longer adjusted by the cooperation of the control wire 135 and the wire winding shaft 136. In this embodiment, the remote control shaft 1114 and the proximal control shaft 1115 only have implantation sections. In this embodiment, the drive assembly includes a third movable member 1114d fixed to the proximal end of the remote control implantation section 1114a, and a third drive member 138 rotatably arranged on the fixing member 130, and the third drive member 138 is used for transmission connection to the third movable member 1114d to drive the remote control shaft 1114 axial movement. Exemplarily, the third drive member 138 is threadedly connected to the third movable member 1114d.

[0134] The distal end of the fixing member 130 of this embodiment is fixed with a sleeve 133. The fixing member 130 is provided with a third drive hole, and the third drive member 138 is accommodated in the third drive hole, and the threaded portion of the third drive member 138 extends into the body. And the third drive member 138 is configured to be able to rotate only relative to the fixing member 130 but not to move relative to the fixing member 130. The proximal end of the third movable member 1114d and the remote control implant section 1114a are movably accommodated in the sleeve 133. And the distal end of the third movable member 1114d is fixedly connected to the remote control implant section 1114a and has an internal thread. And as shown in Figure 26, at least the proximal end of the remote control implant section 1114a is a non-rotating body, that is, the cross-sectional shape is set to a non-perfect circle. The cross-sectional shape of described sleeve 133 and described remote control implant section 1114a adjacent portion is similar, and described remote control implant section 1114a is limited to rotate around its own axis by described sleeve 133, and then the 3rd moving member 1114d also can not rotate.Like this, described the 3rd driving member 138 can drive the described 3rd moving member 1114d and drive the described remote control shaft 1114 relative to described sleeve 133 axial movements.Alternatively, the cross-sectional shape of described 3rd moving member 1114d is set to non-perfect circle, and described sleeve 133 is similar to the cross-sectional shape of described 3rd moving member 1114d adjacent portion, and then the 3rd moving member 1114d is limited to rotate.Similarly, described drive assembly also comprises the 4th moving member 1115e that is fixed on the proximal end of described near control implant section 1115a, and the 4th driving member 139, and described the 4th driving member 139 is used for transmission connection described the 4th moving member 1115e, to drive described near control shaft 1115 axial movements.

[0135] In this embodiment, the distal control axis 1114 and the proximal control axis 1115 can be controlled independently of each other. Therefore, the distal end and the proximal end of the electrode holder 112 can also be controlled independently of each other, and the movement range of the electrode holder 112 is larger.

[0136] Similarly, when driving the remote control shaft 1114 and the proximal control shaft 1115 to move, if the distance between the distal end of the remote control implant segment 1114a and the distal end of the proximal control implant segment 1115a is kept unchanged, the position of the electrode holder 112 can be changed; if the relative position between the remote control implant segment 1114a and the proximal control implant segment 1115a is changed, the spatial structure of the electrode holder 112 can be changed.

[0137] Referring to FIG. 27 , an eighth embodiment of the present invention further provides an electrode array 100. The electrode array 100 of this embodiment is similar to the electrode array 100 of the sixth embodiment, with the primary difference being that the electrode array 100 of this embodiment is not adjusted through the coordination of the control wire 135 and the wire winding shaft 136 . In this embodiment, the drive assembly further includes a distal control ring 1116 and a proximal control ring 1117. Both the distal control ring 1116 and the proximal control ring 1117 are movably connected to the implant segment 111a of the central shaft 111. The distal control ring 1116 is located on the distal side of the proximal control ring 1117. The distal end of the electrode holder 112, such as the distal connection end, is connected to the distal control ring 1116, while the proximal end of the electrode holder 112, such as the proximal connection end, is connected to the proximal control ring 1117. By adjusting the positions of the remote control ring 1116 and the near control ring 1117 on the central axis 111, the spatial structure and / or posture of the electrode holder 112 can be adjusted. In this way, the distal position of the electrode holder 112 will not be limited to the distal end of the central axis 111, and the spatial structure of the electrode holder 112 can be adjusted more flexibly. In addition, after the electrode array 100 is implanted, when the spatial structure of the electrode holder 112 is adjusted again, the depth of the central axis 111 inserted into the body can be kept unchanged, reducing the risk of adjustment. Moreover, the synchronous movement of the remote control ring 1116 and the near control ring 1117 can be used to change the posture of the electrode holder 112 relative to the target tissue in the body, making the adjustment of the electric field distribution around the target tissue in the body more flexible.

[0138] In one example, the distal control ring 1116 and the proximal control ring 1117 are both O-shaped and are sleeved onto the implant segment 111a of the central shaft 111. The distal end of the electrode holder 112, such as the distal connection end, is fixed to the distal control ring 1116, and the proximal end of the electrode holder 112, such as the proximal connection end, is fixed to the proximal control ring 1117. The fixing methods may be adhesive, clamping, suturing, etc. The drive assembly also includes a first control wire 1118 and a second control wire 1119. The first control wire 1118 is used to control the distal control ring 1116, and the second control wire 1119 is used to control the proximal control ring 1117. The distal control ring 1116 is fixedly connected to the first control wire 1118, and the proximal control ring 1117 is fixedly connected to the second control wire 1119. Both the first control wire 1118 and the second control wire 1119 extend proximally to the proximal side of the fixing member 130, i.e., outside the body. By pushing and pulling the first control wire 1118 and the second control wire 1119, respectively, the positions of the distal control ring 1116 and the proximal control ring 1117 on the central axis 111 are controlled, thereby changing the spatial structure and / or posture of the electrode holder 112. The control wires are required to have a certain degree of bending resistance to drive the distal movement of the distal control ring 1116 and the proximal control ring 1117, and to have a certain degree of tensile strength to drive the proximal movement of the distal control ring 1116 and the proximal control ring 1117. In one example, the central axis 111 can also move relative to the fixed member 130 to further expand the range of movement of the distal control ring 1116 and the proximal control ring 1117.

[0139] In other feasible embodiments, as shown in FIG28 , the central shaft 111 is provided with a sliding hole 111c radially extending through the implantation section 111a of the central shaft 111, and the sliding hole extends axially along the central shaft 111. The cross-sections of the distal control ring 1116 and the proximal control ring 1117 can both be configured as "θ"-shaped, i.e., comprising an outer collar and a crossbar radially disposed along the collar. The collars of the distal control ring 1116 and the proximal control ring 1117 are sleeved onto the exterior of the implantation section 111a. The crossbars of the distal control ring 1116 and the proximal control ring 1117 pass through the sliding hole 111c. A control wire extends from the sliding hole and connects to the crossbar, enabling the distal control ring 1116 and the proximal control ring 1117 to move axially along the central shaft 111 under the control wire's drive. For example, in FIG28 , the proximal control ring 1117 comprises a first collar 1117a and a first crossbar 1117b. The first collar 1117a is sleeved on the implantation section 111a, and the first cross bar 1117b passes through the sliding hole 111c. The second control wire 1119 for controlling the near control ring 1117 extends from the sliding hole 111c and is connected to the first cross bar 1117b. Similarly, the far control ring 1116 has a second collar and a second cross bar. The second collar is sleeved on the implantation section 111a, and the second cross bar passes through the sliding hole 111c. The first control wire 1118 for controlling the far control ring 1116 extends from the sliding hole 111c and is connected to the second cross bar. In this way, the control wire is arranged inside the implantation section 111a of the central axis 111 and will not interfere with the tissue in the body. In one example, the outer contours of the far control ring 1116 and the near control ring 1117 are set to be circular.

[0140] Typically, the bolts, positioning pins, control shafts, and control wires, which are used to drive the movement and secure the positions of the central axis 111, the distal control shaft 1114, or the proximal control shaft 1115, are disposed externally to the patient, such as on the outside of the skull. This allows for direct adjustment of the spatial structure or position of the electrode holder 112 without requiring a craniotomy, facilitating ease of use and reducing surgical risks for the patient.

[0141] It should be noted that all the above embodiments can be arbitrarily combined according to actual circumstances without conflicting with each other. For example, in the second to eighth embodiments, any type of the electrode holder 112 provided in the first embodiment can be selected according to actual needs. For another example, when the remote control shaft 1114 and the near control shaft 1115 are used to adjust the spatial structure and / or posture of the electrode holder 112, when the remote control shaft 1114 is controlled by the control wire 135 and the winding shaft 136, the near control shaft 1115 can be positioned by combining the card slot and the positioning member, or by combining the bolt and the nut; or, one of the remote control shaft 1114 and the near control shaft 1115 is positioned by combining the card slot and the positioning member, and the other is positioned by combining the bolt and the nut. Of course, the combination is not limited to this and will not be elaborated here. Alternatively, the fixing member 130 further includes a rotatable component for driving the central axis 111, or the distal control axis 1114 and the proximal control axis 1115 to rotate, thereby driving the electrode holder 112 to rotate, so as to further increase the range of posture adjustment of the electrode holder 112.

[0142] A ninth embodiment of the present invention provides a tumor treatment field medical device. As shown in FIG. 29 , the device comprises a stimulator 200 , an electrode wire 300 , and the electrode array 100 of any of the above embodiments. The stimulator 200 is electrically connected to the electrodes 120 in the electrode array 100 via the electrode wire 300 , and is configured to provide electrical stimulation to the electrodes 120 .

[0143] In this embodiment, the stimulator 200 generates voltages or currents of multiple directions at a certain frequency (e.g., 100 kHz to 300 kHz), which are passed through the electrode array 100 to produce a directionally varying electric field with an intensity generally ranging from 100 V / m to 1000 V / m. Through the specifically shaped electrode array 100, the electric field is applied to target areas where tumor cells may be proliferating, disrupting tumor cell mitosis, thereby causing cancer cell apoptosis and inhibiting tumor growth.

[0144] In one example, the tumor treatment field medical device further includes a relatively fixed pair of electrodes, which are spaced apart from the electrode array 100 to form an electric field with the electrodes 120 in the electrode array 100. In one example, the pair of electrodes are disposed around the electrode array 100 (e.g., located inside the electrode holder 112 and / or outside the electrode holder 112) and are electrically connected to the stimulator via the electrode wires. When the position and / or structure of the electrode holder 112 in the electrode array 100 changes, the electric field distribution between the pair of electrodes and the electrodes 120 in the electrode array 100 also changes accordingly.

[0145] The tumor treatment field medical device of this embodiment adopts the electrode array 100 of any of the above embodiments, and thus has the corresponding technical effects of the electrode array 100 of any of the above embodiments, which will not be described in detail here.

[0146] In one example, the stimulator 200 may include an electric field generating module, a sensing module, and a control module. The sensing module may obtain parameters such as the magnitude of the electric field intensity, or the impedance, current, and temperature of the electrode. The control module may regulate the electric field parameters based on the parameters obtained by the sensing module, such as adjusting the current to adjust the intensity of the electric field, controlling whether the electrode is energized, or changing the shape of the electrode array 100 to change the electric field form. In addition, the control module may also include a function for communicating with external devices, such as a Bluetooth connection or a WiFi connection. In this way, the operator or patient may obtain the status information of the stimulator 200 or control the stimulator 200 to adjust relevant parameters through the wireless communication function of a terminal such as a mobile phone, tablet, computer, or smartwatch. In addition, the stimulator 200 may also include a rechargeable battery and a battery management module. The battery management module may manage the charging and discharging and energy saving of the rechargeable battery to improve the life of the rechargeable battery and enable the stimulator to work for a long time.

[0147] The following briefly describes the method for using the tumor treatment field medical device in an embodiment of the present invention:

[0148] First, the location and size of the target tissue (e.g., a tumor, a tumor-explanted cavity) in the patient's body are determined using imaging equipment or other means. After evaluating the target tissue in the body, the implantation position of the electrode array 100, electric field parameters (e.g., electric field strength, electric field frequency, etc.), and the specific shape of the electrode array 100 (determining the shape of the electric field) are determined.

[0149] Next, the electrode array 100 is surgically implanted into the tumor, removed from the cavity, or positioned to cover the periphery of the tumor. During implantation, the electrode holder 112 can be retracted to reduce the risk of tissue damage and infection caused by the electrode array 100. After implantation, the electrode array 100 is electrically connected to the stimulator 200 via the electrode wires 300 to receive energy and signals.

[0150] The electric field parameters and the spatial arrangement of the electrodes are then set based on the current tumor assessment. Parameters such as the electric field's intensity and frequency can be set via the stimulator 200. The distribution and orientation of the electrodes within the electrode holder 112 can be set by adjusting the position and spatial structure of the electrode holder 112 using the aforementioned drive components, such as the bolts and positioning members. During this setting process, the distribution and coverage of the electric field can be optimized based on the real-time state of the electric field as reported by the sensing module.

[0151] After the implantation procedure, regular follow-up visits are required to examine the size, shape, and characteristics of the tumor to assess the therapeutic efficacy and safety of the TTFields medical device. During these visits, data from the stimulator 200 can be acquired via wireless communication to monitor the state of the electric field and the response of the target tissue in the body.

[0152] Furthermore, the spatial arrangement of the electrodes and the electric field parameters are adjusted according to the examination results to adapt to the current tumor and optimize the treatment effect. During adjustment, the second step of the setting process can be repeated, or the electrode array 100 can be surgically removed or replaced according to actual needs.

[0153] The above describes in detail the electrode array for delivering tumor treatment fields and the tumor treatment field medical device provided by the embodiments of the present invention. Specific examples are used herein to illustrate the principles and implementation methods of the present invention. The description of the above implementation methods is only used to help understand the ideas of the present invention. There may be changes in the specific implementation methods and application scope. In summary, the contents of this specification should not be understood as limiting the present invention.

Claims

1. An electrode array for delivering a tumor treatment field, comprising: an implant body, including a drive assembly and an electrically insulating electrode holder; A plurality of electrodes, wherein the plurality of electrodes are arranged on the electrode support; The electrode support has a spatial structure to fill or cover the target tissue in the body, and multiple electrodes are arranged in space to obtain a three-dimensional electric field; The electrode holder is connected to the distal end of the driving assembly, and the driving assembly is used to drive the electrode holder to change its spatial structure and / or posture so as to change the electric field distribution around the target tissue in the body.

2. The electrode array according to claim 1, wherein: Also included is a fixing member fixed on the body, the fixing member is used to support the implant body; The drive assembly includes a central shaft movably connected to the fixing member, and the central shaft includes an implantation section located in the body; The distal end of the electrode bracket is connected to the distal end of the implant segment, and the proximal end of the electrode bracket is connected to the proximal end of the implant segment, or one end of the electrode bracket is connected to the implant segment and the other end is a free end; The central axis is configured to be driven to move relative to the fixing member to adjust the posture of the electrode holder relative to the target tissue in the body.

3. The electrode array according to claim 2, wherein: The central shaft also includes an external segment located proximal to the implant segment; The driving assembly further comprises a positioning member and a positioning groove arranged on the fixing member, wherein the positioning member is used to be embedded in the positioning groove and clamped with the outer body segment to fix the position of the central axis.

4. The electrode array according to claim 3, wherein: The fixing member is provided with a driving hole for passing the central axis; The positioning groove extends radially inward from the outer peripheral surface of the fixing member and communicates with the driving hole, and the extending direction of the positioning groove is arranged at an angle with the axial direction of the driving hole; The positioning member has a snap-fit ​​hole and a snap-fit ​​notch. When the positioning member is embedded in the positioning groove, the external segment is accommodated in the snap-fit ​​hole through the snap-fit ​​notch, and then the positioning member is snap-fitted with the external segment to fix the external segment.

5. The electrode array according to claim 3, wherein: A positioning portion is provided on the surface of the outer segment, and the positioning portion is used to abut against two axial sides of the positioning member to fix the positioning member and the central axis.

6. The electrode array according to claim 3, wherein: The driving assembly further includes a stop pin, a first stop hole provided on the fixing member, and a second stop hole provided on the positioning member. The first stop hole is used to align with the second stop hole when the central axis rotates to a desired position, and the stop pin is used to be inserted into the first stop hole and the second stop hole when the first stop hole and the second stop hole are aligned.

7. The electrode array according to claim 1, wherein: Also included is a fixing member fixed on the body, the fixing member is used to support the implant body; The driving assembly comprises a central shaft movably connected to the fixing member, the central shaft comprises an implantation segment for being arranged in the body, the distal end of the electrode holder is connected to the distal end of the implantation segment, and the proximal end of the electrode holder is axially stationary relative to the fixing member; The central axis is configured to be driven to move axially relative to the fixing member to adjust the axial distance between the distal end of the electrode holder and the proximal end of the electrode holder, thereby adjusting the spatial structure of the electrode holder.

8. The electrode array according to claim 7, wherein: The drive assembly also includes a control wire and a wire winding shaft, the wire winding shaft is rotatably arranged on the fixing piece, and a control through hole is provided in the middle of the implant segment at an angle to the axial direction of the central axis. One end of the control wire is relatively stationary relative to the axial direction of the fixing piece or is fixed to the proximal end of the implant segment, and the other end extends toward the distal end, and after passing through the control through hole, extends toward the proximal end and is wound on the wire winding shaft, and the wire winding shaft is used to wind or release the control wire to allow the central axis to move axially relative to the fixing piece.

9. The electrode array according to claim 7, wherein: The driving assembly also includes an elastic member, a control wire and a wire winding shaft; The wire winding shaft is rotatably arranged on the fixing part, a control through hole is arranged in the middle of the implant segment at an angle to the axial direction of the central axis, one end of the control wire is relatively stationary relative to the axial direction of the fixing part or is fixed to the proximal end of the implant segment, and the other end extends toward the distal end, and after passing through the control through hole, extends toward the proximal end and is wound on the wire winding shaft, and the wire winding shaft is used to wind or release the control wire to make the central axis move axially relative to the fixing part; The proximal end of the elastic member remains relatively fixed axially, and the distal end of the elastic member abuts or is fixed to the proximal end of the implant segment. The elastic member is compressed when the control wire is rolled up by the wire winding shaft and the implant segment moves toward the proximal end, and drives the implant segment to move toward the distal end when the wire winding shaft releases the control wire.

10. The electrode array according to claim 7, wherein: The driving assembly also includes a moving part fixedly arranged at the proximal end of the implant segment, and a driving part rotatably arranged on the fixing part, wherein the driving part is transmission-connected to the moving part and is used to drive the moving part to move so as to drive the central axis to move axially.

11. The electrode array according to claim 10, wherein: A sleeve is fixed at the distal end of the fixing member, the proximal end of the implant segment and the movable member are accommodated in the sleeve, and the proximal end of the electrode holder is connected to the sleeve or the fixing member; The moving member and / or the proximal end of the implant segment are configured to be axially movable relative to the sleeve and circumferentially stationary; The driving member is configured to be rotatable in the circumferential direction relative to the fixing member and to be stationary in the axial direction; The moving member and the driving member are threadedly connected.

12. The electrode array according to claim 7, wherein: The central shaft also includes an external segment located proximal to the implant segment; The driving assembly further comprises a positioning member and a positioning groove arranged on the fixing member, wherein the positioning member is used to be embedded in the positioning groove and clamped with the outer body segment to fix the position of the central axis.

13. The electrode array according to claim 12, wherein: The fixing piece is provided with a driving hole for the central axis to pass through; The positioning groove extends radially inward from the outer peripheral surface of the fixing member and communicates with the driving hole, and the extending direction of the positioning groove is arranged at an angle with the axial direction of the driving hole; The positioning member has a snap-fit ​​hole and a snap-fit ​​notch. When the positioning member is embedded in the positioning groove, the external segment is accommodated in the snap-fit ​​hole through the snap-fit ​​notch, and then the positioning member is snap-fitted with the external segment to fix the external segment.

14. The electrode array according to claim 12, wherein: A positioning portion is provided on the surface of the outer segment, and the positioning portion is used to abut against two axial sides of the positioning member to fix the positioning member and the outer segment.

15. The electrode array according to claim 1, wherein: Also included is a fixing member fixed on the body, the fixing member is used to support the implant body; The driving assembly comprises a distal control shaft and a proximal control shaft, both of which are axially movable relative to the fixing member, the distal control shaft comprises a distal control implantation section for being arranged in the body, and the proximal control shaft comprises a proximal control implantation section for being arranged in the body; The distal end of the electrode bracket is connected to the distal end of the remote control implant segment, and the proximal end of the electrode bracket is connected to the distal end of the proximal control implant segment; The electrode holder is configured to adjust the positions of the remote control implant section and the near control implant section to adjust the spatial structure and / or posture of the electrode holder.

16. The electrode array according to claim 15, wherein: The distal control shaft further comprises a distal control body segment located at the proximal end of the distal control implant segment, and the proximal control shaft further comprises a proximal control body segment located at the proximal end of the proximal control implant segment; The driving assembly further comprises a positioning member and a positioning slot disposed on the fixing member; The positioning member is used to be embedded in the positioning groove and simultaneously clamp the outer section of the remote control body and the outer section of the near control body to fix the positions of the remote control axis and the near control axis.

17. The electrode array according to claim 16, wherein: The outer section of the remote control body is provided with a first sub-positioning portion, and the outer section of the near control body is provided with a second sub-positioning portion. The first sub-positioning portion and the second sub-positioning portion are used to simultaneously abut against both axial sides of the positioning member to fix the outer section of the remote control body and the outer section of the near control body.

18. The electrode array according to claim 15, wherein: The drive assembly further comprises a control wire and a wire winding shaft, wherein the wire winding shaft is rotatably arranged on the fixing member, the remote control implant section is provided with a control through hole which is at an angle to the axial direction of the remote control shaft, one end of the control wire is relatively stationary relative to the axial direction of the fixing member or is fixed to the proximal end of the remote control implant section, and the other end of the control wire extends toward the distal end, and after passing through the control through hole, extends toward the proximal end and is wound on the wire winding shaft; The driving assembly also includes a moving member fixed to the proximal end of the proximal control implant section, and a driving member rotatably arranged on the fixed member, wherein the driving member is transmission-connected to the moving member to drive the moving member to drive the proximal control shaft to move axially.

19. The electrode array according to claim 15, wherein: The driving assembly further comprises a first moving member fixedly mounted at the proximal end of the remote control implant section, a second moving member fixedly mounted at the proximal end of the near control implant section, and a first driving member and a second driving member rotatably mounted at the fixing member; The first driving member is transmission-connected to the first moving member, and the first driving member is used to drive the first moving member to drive the remote control shaft to move axially; The second driving member is drivingly connected to the second moving member, and the second driving member is used to drive the second moving member to drive the proximal control shaft to move axially.

20. The electrode array according to claim 19, wherein: A sleeve is fixed at the distal end of the fixing member, and the distal control implantation section, the proximal end of the proximal control implantation section, the first movable member and the second movable member are accommodated in the sleeve; The first moving member and / or the proximal end of the remote control implant segment are configured to be axially movable relative to the sleeve and circumferentially stationary; The second moving member and / or the proximal end of the proximal control implant segment are configured to be axially movable relative to the sleeve and circumferentially stationary; The first driving member and the second driving member are configured to be rotatable in the circumferential direction relative to the fixing member and to be stationary in the axial direction; The first driving member and the first moving member are threadedly connected; The second driving member and the second moving member are threadedly connected.

21. The electrode array according to claim 1, wherein: The driving assembly comprises a central axis, a remote control ring and a near control ring, the central axis comprises an implantation section located in the body, the remote control ring and the near control ring are both movably arranged on the implantation section, the distal end of the electrode holder is connected to the remote control ring, and the proximal end of the electrode holder is connected to the near control ring; The electrode holder is configured to drive the distal control ring and / or the proximal control ring to move axially to adjust the position of the distal end of the electrode holder and / or the proximal end of the electrode holder to change the spatial structure and / or posture of the electrode holder.

22. The electrode array according to claim 21, wherein: The implant segment has a sliding hole penetrating in the radial direction, and the sliding hole extends along the axial direction of the implant segment, the proximal control ring includes an external first ring and a first crossbar radially arranged along the first ring, and the distal control ring includes an external second ring and a second crossbar radially arranged along the second ring; The drive assembly includes a first control wire and a second control wire; The first sleeve ring and the second sleeve ring are respectively sleeved on the outside of the implant segment, the first cross bar and the second cross bar respectively pass through the sliding hole, the second control wire extends from the sliding hole and is connected to the first cross bar, so that the near control ring moves along the axial direction of the implant segment, and the first control wire extends from the sliding hole and is connected to the second cross bar, so that the far control ring moves along the axial direction of the implant segment.

23. The electrode array according to any one of claims 1 to 22, wherein: The electrode support includes a plurality of segments, and at least some of the segments include a metal layer and an insulating layer arranged outside the metal layer in a radial direction, and at least some of the insulating layers are arranged discontinuously in an axial direction to form an insulating gap, and the metal layer exposed in the insulating gap serves as the electrode.

24. The electrode array according to claim 23, wherein: It also includes an electrode sheet, which is electrically connected to the exposed metal layer to serve as the electrode.

25. The electrode array according to any one of claims 2, 7 and 21, wherein: The electrode is arranged on the central axis.

26. The electrode array according to claim 15, wherein: The electrodes are arranged on the distal control shaft and / or the proximal control shaft.

27. The electrode array according to claim 2, wherein: The electrode support has a tetrahedral structure, a semi-ellipsoidal structure, a spiral cone structure or an octahedral structure.

28. The electrode array according to any one of claims 1, 2, 7-21, wherein: The electrode support has an ellipsoid structure, a spiral spindle structure or a bidirectional helical structure.

29. The electrode array according to claim 8 or 9, wherein: Between the control through hole and the proximal end of the implant segment, two control channels are arranged on the tube wall of the implant segment for the control wire to pass through.

30. A tumor treatment field medical device, comprising a stimulator, an electrode wire and an electrode array as described in any one of claims 1 to 29, wherein the stimulator is electrically connected to electrodes of the electrode array via the electrode wire, and the stimulator is used to provide electrical stimulation to the electrodes.

31. The tumor treatment field medical device of claim 30, wherein: It also includes a pair of electrodes, which are arranged around the electrode array and are used to form a three-dimensional electric field with the electrodes on the electrode array.

32. The tumor treatment field medical device of claim 31, wherein: Conductive gel is provided in the space formed by the electrode support of the electrode array, or in the space between the electrode support of the electrode array and the pair of electrodes.

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