Mother-son needle type pulsed electric field ablation electrode

Abstract

The invention discloses a primary-secondary needle type pulsed electric field ablation electrode, and belongs to the technical field of tumor ablation, the primary-secondary needle type pulsed electric field ablation electrode comprises a primary needle, a hollow electrode needle is arranged in the primary needle, at least two needle outlet holes are distributed in the primary needle, and the needle outlet holes are communicated with the primary needle and the interior of the hollow electrode needle; the hollow electrode needle is internally provided with at least two insulating sleeves, the insulating sleeves are internally provided with sub-needles, and the sub-needles can move relative to the needle outlet hole. The device solves the problems that a traditional pulse electric field ablation electrode needs to ensure that multiple electrode needles are parallel, so that the operation difficulty is large, the patient injury risk is high, and a traditional single-needle type treatment electrode is small in ablation range and high in treatment efficiency. And large tumors are difficult to cover.

Description

Technical Field

[0001] The present invention relates to the technical field of tumor ablation, and in particular to a mother-and-child needle type pulse electric field ablation electrode. Background Art

[0002] Pulsed electric field ablation is a new type of local physical therapy technology for tumors. The voltage of the pulsed electric field can be as high as thousands to tens of thousands of volts, and the pulse duration can be as long as milliseconds or as short as picoseconds. Unlike the currently widely used radiofrequency ablation, microwave ablation, cryoablation and other technologies, it releases electric pulses into the tumor tissue, causing irreversible electroporation of the cell membrane, and killing tumor cells in a targeted manner. It has achieved good therapeutic effects in the treatment of various tumors such as melanoma, hepatocellular carcinoma, renal cell carcinoma, and pancreatic cancer. In addition, because the pulsed electric field directly kills cells in a non-thermal dependent manner, the damage to non-cellular structures such as blood vessels, bile ducts, and extracellular matrix is ​​very slight. When ablating tumors near important parts such as blood vessels, pulsed electric fields have a mechanistic advantage compared to traditional tumor thermal ablation technology.

[0003] Pulsed electric fields need to rely on metal electrodes to transmit them to human tumor tissues in order to exert their tumor ablation effect. For tumors located under the skin, such as melanoma, the pulsed electric field ablation electrode can be inserted into the lesion area under visual observation, which is convenient for inserting multiple treatment electrodes at the same time to ensure the treatment range; for solid tumors located in deep organs, such as liver cancer and pancreatic cancer, the pulsed electric field ablation electrode needs to reach the tumor location through skin puncture or through laparoscopy under local anesthesia or general anesthesia. In order to ensure the efficiency and accuracy of tumor ablation, this process has high requirements for operation. In addition, thermal ablation techniques such as radiofrequency ablation or microwave ablation rely on the high temperature of the ablation needle to kill tumors, and only a single needle is needed to complete the ablation treatment; although pulsed electric field ablation has the advantages of extremely low thermal effect and no damage to vascular structure, it can ablate tumors near large blood vessels and bile ducts, which are forbidden areas of traditional thermal ablation techniques, but pulsed electric fields often require two electrode needles, positive and negative, and the operation is more complicated.

[0004] The shape of the pulsed electric field ablation electrode can be a plate electrode, a needle electrode, etc., but no matter what the shape is, the two metal electrodes need to remain parallel to each other to ensure the maximization of the effective ablation area and the stability of its shape. To this end, the existing technology provides many solutions to expand the ablation area and stability, such as the existing patent LU102975, which provides a multi-needle tip extended radiofrequency ablation electrode needle including: a cannula needle, one end of which is provided with a needle outlet, and the cannula needle is provided with a plurality of electrode sub-needles that can extend out of the needle outlet and extend outward and bend, and the plurality of electrode sub-needles The handle is fixedly arranged in the trocar along the circumferential direction; a handle is fixedly arranged at the other end of the puncture device, and a plurality of sliding metal slide bars are arranged in the handle, one end of the metal slide bar is connected to the electrode needle, and the other end of the metal slide bar is connected to the radiofrequency therapeutic device; and a plurality of control sliders are slidably arranged on a peripheral wall of the handle. For example, the pulsed electric field ablation electrodes disclosed in the existing patent technologies CN110179534A and CN212395035U require at least two electrode needles to be punctured in parallel to the tumor site to transmit the pulsed electric field and kill the tumor. Taking the ablation of liver tumors as an example, for the operating physician, it is necessary to ensure that multiple electrode needles are parallel to each other under the assistance of ultrasound, and to avoid damaging the main blood vessels and bile ducts in the liver during puncture, which undoubtedly increases the difficulty of operation and the risk of injury, and to a certain extent limits the development and application prospects of pulsed electric field ablation. Summary of the invention

[0005] The purpose of the present invention is to provide a mother-and-child needle type pulse electric field ablation electrode to solve the problems that traditional pulse electric field ablation electrodes require multiple electrode needles to be parallel, resulting in greater difficulty in operation and a higher risk of patient injury, and that previous single-needle treatment electrodes have a smaller ablation range and are difficult to cover larger tumors.

[0006] In order to solve the above technical problems, the present invention specifically provides the following technical solutions: a mother-and-child needle type pulse electric field ablation electrode, comprising: a mother needle, a hollow electrode needle is built into the mother needle, at least two needle exit holes are arranged on the mother needle, and the needle exit holes are connected to the mother needle and the inside of the hollow electrode needle; the hollow electrode needle is built with at least two insulating sleeves, and the insulating sleeves are built with a child needle, and the child needle can be displaced relative to the needle exit hole. The structure through which the needle exit hole passes includes a hollow electrode needle, an insulating interlayer, a first arc-shaped electrode sheet, a third arc-shaped electrode sheet, a second arc-shaped electrode sheet, and a fourth arc-shaped electrode sheet. The upper, lower, left and right sides of the needle exit hole are covered with an inner insulating layer, and the outside is covered with a thin film-like outer insulating layer. When the child needle is not used, it will not affect the use of the mother needle as a single-needle ablation electrode alone; when the child needle is used, the child needle will penetrate the outer insulating layer and enter the human tissue after passing through the lower end outlet of the insulating sleeve. The needle exit hole is rectangular, and the width is slightly wider than the diameter of the child needle, and the length determines the adjustable upper and lower angles of the child needle.

[0007] The ablation electrode of the present invention is a composite mother-and-child needle design. After the mother needle is inserted into the tumor area, the child needles pass through the needle exit holes in the middle of the mother needle and are distributed in the tumor area for ablation. The number of child needles can be variable, but there must be at least two to ensure that the ablation range and usage mode are variable. The insulating sleeve can limit the movement range of the child needle in the mother needle, so that it can move controllably within a limited trajectory. The ablation mode can change with the switching of positive and negative poles, thereby achieving the effect of expanding the ablation area and accurately ablating the tumor without having to keep multiple needles in parallel.

[0008] According to one embodiment of the present invention, the outlet end of the insulating sleeve corresponds to the position of the needle outlet hole, and an angle adjustment device is provided between the insulating sleeve and the hollow electrode needle. The angle adjustment device includes a guide plate provided between the insulating sleeve and the hollow electrode needle, one end of the guide plate is hinged to the guide plate connecting rod, and one end of the guide plate connecting rod is hinged to the output shaft of the stepper motor. The output shaft of the stepper motor is arranged parallel to the axis of the hollow electrode needle and a miniature stepper motor is connected to the end.

[0009] An insulating fixed column is provided at the center of the hollow electrode needle, a hollow track is provided in the middle section of the guide plate, a guide plate rotating shaft is inserted in the hollow track, and the guide plate rotating shaft is connected to the insulating fixed column through a rotating shaft bracket. The guide plate rotating shaft is arranged horizontally. The guide plate connecting rod is provided with a guide plate connecting rod fixing tube outside, and the guide plate connecting rod can move horizontally relative to the guide plate connecting rod fixing tube. The guide plate connecting rod fixing tube is connected to the insulating fixed column through a fixing tube bracket, and the axis of the guide plate connecting rod fixing tube is arranged perpendicularly to the axis of the insulating fixed column, and the guide plate connecting rod fixing tube is arranged horizontally. An output shaft fixing tube parallel to the axis of the insulating fixed column is provided on the outside of the insulating fixed column, and the output shaft fixing tube is connected to the insulating fixed column. The output shaft of the stepper motor is arranged in the output shaft fixing tube and can be displaced relative to the output shaft fixing tube.

[0010] The output shaft of the stepper motor runs vertically on the surface of the solid insulating fixed column, the upper end of which is connected to the micro stepper motor, the lower section of which passes through the output shaft fixed tube to ensure vertical displacement, and the lower end of which is connected to the guide plate connecting rod through a bearing; the guide plate connecting rod is divided into two sections, the inner and outer sections, which are hinged, the inner section connects the stepper motor output shaft and the outer section, the outer section passes through the guide plate connecting rod fixed tube to ensure horizontal displacement, and is connected to the guide plate by an intersection; the middle section of the guide plate is provided with a hollow track, which can be used for the guide plate rotating shaft to rotate axially and move along the track, ensuring that the upper end of the guide plate can be at the same level as the guide plate connecting rod; the guide plate connecting rod fixed tube and the guide plate rotating shaft are fixed to the solid insulating fixed column through the fixed tube bracket and the rotating shaft bracket respectively. Six groups of insulating sleeves and angle adjustment devices are evenly distributed in a centripetal manner. The micro stepper motor can cause the output shaft of the stepper motor to produce vertical displacement, which is converted into horizontal displacement through the guide plate connecting rod, driving the guide plate to deflect, abutting against the insulating sleeve and causing it to displace, thereby adjusting the bending angle of the insulating sleeve. In this process, the position state of the insulating sleeve can be determined by the guide plate, and the problem of the sub-needle being offset by force when in contact with the tissue is solved. That is, the guide plate can ensure that the insulating sleeve and the sub-needle are prevented from displacement and shaking. In addition, the position state of the insulating sleeve can be controlled by controlling the guide plate to control the needle outlet angle of the sub-needle.

[0011] According to one embodiment of the present invention, a first arc-shaped electrode sheet and a third arc-shaped electrode sheet are disposed opposite to each other on the side of the hollow electrode needle, and a second arc-shaped electrode sheet and a fourth arc-shaped electrode sheet are disposed opposite to each other on the side of the hollow electrode needle, for forming an ablation area around the hollow electrode needle.

[0012] According to one embodiment of the present invention, an insulating interlayer is provided between the hollow electrode needle and the first arc-shaped electrode sheet, the third arc-shaped electrode sheet, the second arc-shaped electrode sheet and the fourth arc-shaped electrode sheet, and the inner wall of the hollow electrode needle is covered with an inner insulating layer. The upper end of the insulating fixing column is fixedly connected to the inner insulating layer through a rod body or a connector. The insulating interlayer is used to form a state of mutual insulation. For complex anatomical areas, the insulating interlayer can prevent short circuits caused by contact between the electrode and surrounding tissues or liquids, ensure accurate conduction of current, and concentrate energy in the target area to enhance the treatment effect. More importantly, the insulating layer can prevent the current from spreading to non-target areas and causing the risk of damage to healthy tissues.

[0013] According to one embodiment of the present invention, one end surface of the first arc-shaped electrode sheet, the third arc-shaped electrode sheet, the second arc-shaped electrode sheet and the fourth arc-shaped electrode sheet is covered with an outer insulating layer. The outer side of the first arc-shaped electrode sheet, the third arc-shaped electrode sheet, the second arc-shaped electrode sheet and the fourth arc-shaped electrode sheet is covered with an outer insulating layer. The lower section of the first arc-shaped electrode sheet, the third arc-shaped electrode sheet, the second arc-shaped electrode sheet and the fourth arc-shaped electrode sheet is not covered with an outer insulating layer. The provision of the insulating layer can control the action area to prevent the current from spreading to non-target areas, reduce damage to normal tissues, and the insulating layer can reduce the adhesion of the electrode needle to the surrounding tissues, reduce the difficulty of surgery and the risk of complications. When the sub-needle is not used, it will not affect the use of the mother needle as a single-needle ablation electrode alone; when the sub-needle is used, the sub-needle will penetrate the outer insulating layer and enter the human tissue after passing through the lower end outlet of the insulating sleeve.

[0014] According to one embodiment of the present invention, the area where the first arc-shaped electrode sheet is not covered by the outer insulating layer constitutes the first arc-shaped electrode sheet ablation zone, the area where the third arc-shaped electrode sheet is not covered by the outer insulating layer constitutes the third arc-shaped electrode sheet ablation zone, the area where the second arc-shaped electrode sheet is not covered by the outer insulating layer constitutes the second arc-shaped electrode sheet ablation zone, and the area where the fourth arc-shaped electrode sheet is not covered by the outer insulating layer constitutes the fourth arc-shaped electrode sheet ablation zone. The first arc-shaped electrode sheet ablation zone is directly opposite to the third arc-shaped electrode sheet ablation zone and is incorrectly arranged up and down, and the second arc-shaped electrode sheet ablation zone is directly opposite to the fourth arc-shaped electrode sheet ablation zone and is incorrectly arranged up and down. The adjacent arc-shaped electrode sheet ablation zones are not located at the same level, which can achieve the expansion of the ablation coverage area, improve the ablation efficiency and range, and is suitable for tumors of different shapes and reduces omissions.

[0015] According to one embodiment of the present invention, the end of the hollow electrode needle has a hollow electrode needle tip ablation zone, and the surface of the hollow electrode needle tip ablation zone is not covered with an outer insulating layer to ensure ablation.

[0016] According to one embodiment of the present invention, a solid electrode needle is provided inside the sub-needle, an arc-shaped sub-needle electrode sheet is provided outside the solid electrode needle, a sub-needle insulating interlayer is distributed between the solid electrode needle and the arc-shaped sub-needle electrode sheet, and a sub-needle outer insulating layer is covered outside the sub-needle insulating interlayer. The provision of the sub-needle outer insulating layer can control the action area to prevent the current from spreading to non-target areas, reduce damage to normal tissues, and the sub-needle outer insulating layer can reduce the adhesion of the electrode needle to surrounding tissues, reducing the difficulty of surgery and the risk of complications. According to one embodiment of the present invention, the lower section of the arc-shaped sub-needle electrode sheet is provided with an arc-shaped sub-needle electrode sheet ablation zone, and the surface of the arc-shaped sub-needle electrode sheet is not covered by the sub-needle outer insulating layer; the lower section of the solid electrode needle is provided with a solid electrode needle tip and a solid electrode needle side ablation zone, and both the solid electrode needle tip and the solid electrode needle side ablation zone are not covered by the sub-needle outer insulating layer. The arc-shaped sub-needle electrode sheet ablation zone and the solid electrode needle side ablation zone are relatively staggered and are not located in the same horizontal plane. The upper sections of the solid electrode needle and the arc-shaped sub-needle electrode sheet are provided with an arc-shaped thickened portion, which are the sub-needle outer contact sheet and the sub-needle inner contact sheet, respectively. The surfaces of the two are slightly higher than the surface of the sub-needle outer insulating layer, and are not covered by insulating material, to ensure good contact and electrical conductivity. The side surface of the top end of the sub-needle is provided with a wedge tooth, which protrudes from the sub-needle surface, is continuous with the sub-needle outer insulating layer, and is located on the same side of the sub-needle inner contact sheet.

[0017] Compared with the prior art, the present invention has the following beneficial effects: 1. The present invention proposes a mother-and-child needle type pulsed electric field ablation electrode, in which the positive and negative electrodes of the pulsed electric field are integrated into one electrode device at the same time, solving the problem that the electrode needles of the traditional ablation electrode need to be kept parallel to each other. A single needle can complete the ablation treatment, which reduces the difficulty of operation and improves the reliability and convenience of treatment; 2. The mother-and-child needle design of the present invention determines that when the child needle is inserted and deployed, it will have a larger ablation area, which overcomes the shortcomings of the existing single-needle ablation electrode, which has a small ablation area and is difficult to cover larger tumors. It improves the ablation efficiency of pulsed electric field tumor treatment and expands the range of tumor sizes that can be ablated by the treatment electrode; 3. When the ablation electrode of the present invention is used only with the mother needle for ablation, the hollow electrode needle and the arc-shaped electrode sheet can be connected to the same socket, and a second ablation electrode of the present invention or an ordinary ablation electrode can be used to perform traditional multi-needle parallel ablation. Then, based on the actual ablation situation, it can be decided whether to use the sub-needle for further treatment. This retains the functions of the traditional ablation electrode and expands the scope of application of the ablation electrode of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the implementation modes of the present invention or the technical solutions in the prior art, the drawings required for use in the description of the implementation modes or the prior art are briefly introduced below.

[0019] Figure 1 A schematic diagram of a mother-and-child needle type pulsed electric field ablation electrode scheme; Figure 2 It is a schematic diagram of the angle adjustment device inside the hollow electrode needle; Figure 3 It is a schematic diagram of the layout of the first arc-shaped electrode sheet and the third arc-shaped electrode sheet; Figure 4 A schematic diagram of a top-down perspective of the angle adjustment device inside the hollow electrode needle; Figure 5 It is a schematic diagram of the connection scheme between the insulating fixed column and the rotating shaft support; Figure 6 Schematic diagram of the positional relationship between the ablation zone of the first arc-shaped electrode sheet and the ablation zone of the third arc-shaped electrode sheet; Figure 7 Schematic diagram of the positional relationship between the ablation zone of the second arc-shaped electrode sheet and the ablation zone of the fourth arc-shaped electrode sheet; Figure 8 It is a schematic diagram of the solid electrode needle scheme; Fig. 9 It is a schematic diagram of a solid electrode needle, an arc-shaped sub-needle electrode sheet, and a sub-needle insulating interlayer; Fig.10 A schematic diagram of a horizontal cross-sectional structure of an angle adjustment device in a grip portion; Fig.11 It is a schematic diagram of the connection scheme between the outer engaging wheel motor and the sub-needle adjustment control line; Fig.12 This is a schematic diagram of the connection scheme between the micro stepper motor and the stepper motor wire; Fig.13 It is a schematic diagram of the insulating needle scheme; Fig.14 It is a schematic diagram of the solid electrode needle and the sub-needle insulating interlayer, the sub-needle outer insulating layer, and the sub-needle outer contact piece; Fig.15 It is a schematic diagram of the wedge tooth scheme; Fig.16 It is a partial schematic diagram of the scheme of the solid electrode needle and the sub-needle insulating interlayer, the sub-needle outer insulating layer, and the sub-needle outer contact piece; Fig.17 It is a schematic diagram of the layout of the contact piece inside the sub-pin; Fig.18 This is a schematic diagram of the layout of the outer insulation layer of the sub-pin; Fig.19 This is a schematic diagram of the arc-shaped sub-needle electrode ablation zone layout plan; Fig. 20 This is a schematic diagram of the layout of the ablation area on the solid electrode needle side; Fig.21 It is a schematic diagram of the connection scheme between the micro-control mainboard and the second circular button; Fig. 22 It is a top view of the internal structure of the hollow electrode needle; Fig.23 It is a schematic diagram of the connection scheme between the micro-control mainboard and the first circular button, the second circular button, the first sub-switch, and the second sub-switch; Fig.24 A schematic diagram of a connection scheme of a first sub-switch, a second sub-switch, a first sub-switch control line, and a second sub-switch control line; Fig.25 Schematic diagram of the internal structure of the handle.

[0020] Explanation of reference numerals: 1. Hollow electrode needle; 2. Needle hole; 3. First arc-shaped electrode sheet; 4. Second arc-shaped electrode sheet; 5. Third arc-shaped electrode sheet; 6. Fourth arc-shaped electrode sheet; 7. Insulating interlayer; 8. Inner insulating layer; 9. Outer insulating layer; 10. First arc-shaped electrode sheet ablation zone; 11. Second arc-shaped electrode sheet ablation zone; 12. Third arc-shaped electrode sheet ablation zone; 13. Fourth arc-shaped electrode sheet ablation zone; 14. Hollow electrode needle tip ablation zone; 15. Insulating sleeve; 16. Insulating fixing column; 17. Stepper motor output shaft; 18. Output Output shaft fixing tube; 19. Guide plate connecting rod; 20. Guide plate connecting rod fixing tube; 21. Guide plate; 22. Guide plate rotating shaft; 23. Rotating shaft bracket; 24. Fixed tube bracket; 25. Solid electrode needle; 26. Arc-shaped sub-needle electrode sheet; 27. Sub-needle insulation interlayer; 28. Sub-needle outer insulation layer; 29. ​​Arc-shaped sub-needle electrode sheet ablation area; 30. Solid electrode needle side ablation area; 31. Solid electrode needle tip; 32. Sub-needle outer contact sheet; 33. Sub-needle inner contact sheet; 34. Wedge tooth; 35. Fixing part; 36. Handle; 37. Wedge groove; 38. Inner bite wheel; 39. Outer bite wheel; 40. Insulation needle; 41. Micro stepper motor; 42. Stepper motor wire; 43. First plug; 44. Second plug; 45. First round button; 46. Second round button; 47. Outer bite wheel motor; 48. Microcontroller motherboard; 49. LCD screen; 50. Button battery; 51. Increase button; 52. Decrease button; 53. Third round button; 54. Fourth round button; 55. Inner bite wheel wire; 56. Outer bite wheel wire; 57. Sub-needle adjustment control line ; 58. Hollow electrode needle wire; 59. First switch; 60. First sub-switch; 61. Second sub-switch; 62. Third sub-switch; 63. Fourth sub-switch; 64. First arc-shaped electrode sheet wire; 65. Second arc-shaped electrode sheet wire; 66. Third arc-shaped electrode sheet wire; 67. Fourth arc-shaped electrode sheet wire; 68. First sub-switch control wire; 69. Second sub-switch control wire; 70. Third sub-switch control wire; 71. Fourth sub-switch control wire; 72. First plug wire; 73. Second plug wire; 80. First groove. DETAILED DESCRIPTION

[0021] The present application will be described in detail below with reference to the accompanying drawings and in combination with embodiments.

[0022] Embodiment 1: like Figure 1-Figure 25As shown, the present invention provides a mother-and-child needle type pulse electric field ablation electrode, comprising: a mother needle, a hollow electrode needle 1 is built in the mother needle, at least two needle exit holes 2 are arranged on the mother needle, and the needle exit holes 2 are connected with the mother needle and the inside of the hollow electrode needle 1; the hollow electrode needle 1 is built with at least two insulating sleeves 15, and the insulating sleeves 15 are built with sub-needles, and the sub-needles can be displaced relative to the needle exit holes 2. The structure through which the needle exit hole 2 passes includes the hollow electrode needle 1, the insulating interlayer 7, the first arc-shaped electrode sheet 3, the third arc-shaped electrode sheet 5, the second arc-shaped electrode sheet 4 and the fourth arc-shaped electrode sheet 6, and the upper, lower, left and right sides of the needle exit hole 2 are covered with an inner insulating layer 8, and the outside is covered with a thin film-like outer insulating layer 9. When the sub-needle is not used, it will not affect the use of the mother needle as a single-needle ablation electrode alone; when the sub-needle is used, the sub-needle will penetrate the outer insulating layer 9 after passing through the lower end outlet of the insulating sleeve 15 and enter the human body tissue. The needle hole 2 is rectangular, slightly wider than the diameter of the sub-needle, and the length determines the adjustable up and down angles of the sub-needle. The ablation electrode of the present invention is a composite mother-and-child needle design. After the mother needle is inserted into the tumor area, the sub-needle passes through the needle hole 2 in the middle of the mother needle and is distributed in the tumor area for ablation. The number of sub-needles can be changed, but there must be at least two to ensure that the ablation range and usage mode are variable. The insulating sleeve 15 can limit the movement range of the sub-needle in the mother needle, so that it can move controllably within the limited trajectory. The ablation mode can change with the switching of the positive and negative poles, so as to achieve the effect of not needing to keep multiple needles parallel, expanding the ablation area, and accurately ablating the tumor.

[0023] The outlet end of the insulating sleeve 15 corresponds to the position of the needle hole 2. An angle adjustment device is provided between the insulating sleeve 15 and the hollow electrode needle 1. The angle adjustment device includes a guide plate 21 provided between the insulating sleeve 15 and the hollow electrode needle 1. One end of the guide plate 21 is hinged to the guide plate connecting rod 19. One end of the guide plate connecting rod 19 is hinged to the stepper motor output shaft 17. The stepper motor output shaft 17 is arranged parallel to the axis of the hollow electrode needle 1 and a micro-stepping motor is connected to the end. An insulating fixed column 16 is provided at the center of the hollow electrode needle 1. A hollow track is provided in the middle section of the guide plate 21. A guide plate rotating shaft 22 is inserted into the hollow track. The guide plate rotating shaft 22 is connected to the insulating fixed column 16 through a rotating shaft bracket 23. The guide plate rotating shaft 22 is arranged horizontally. The guide plate connecting rod 19 is externally provided with a guide plate connecting rod fixing tube 20, and the guide plate connecting rod 19 can move horizontally relative to the guide plate connecting rod fixing tube 20. The guide plate connecting rod fixing tube 20 is connected to the insulating fixing column 16 through a fixing tube bracket 24. The axis of the guide plate connecting rod fixing tube 20 is arranged perpendicularly to the axis of the insulating fixing column 16, and the guide plate connecting rod fixing tube 20 is arranged horizontally. An output shaft fixing tube 18 parallel to the axis of the insulating fixing column 16 is arranged outside the insulating fixing column 16, and the output shaft fixing tube 18 is connected to the insulating fixing column 16. The stepper motor output shaft 17 is arranged in the output shaft fixing tube 18 and can move relative to the output shaft fixing tube 18.

[0024] The stepper motor output shaft 17 runs vertically on the surface of the solid insulating fixed column 16, and its upper end is connected to the micro stepper motor 41, and its lower section passes through the output shaft fixed tube 18 to ensure vertical displacement, and its lower end is connected to the guide plate connecting rod 19 through a bearing; the guide plate connecting rod 19 is divided into two sections, inner and outer, and the two sections are hinged, the inner section connects the stepper motor output shaft 17 and the outer section, and the outer section passes through the guide plate connecting rod fixed tube 20 to ensure horizontal displacement, and is connected to the guide plate 21 by an intersection; a hollow track is provided in the middle section of the guide plate 21, which can be used for the guide plate rotating shaft 22 to rotate axially and move along the track, ensuring that the upper end of the guide plate 21 can be at the same level as the guide plate connecting rod 19; the guide plate connecting rod fixed tube 20 and the guide plate rotating shaft 22 are fixed on the solid insulating fixed column 16 through the fixed tube bracket 24 and the rotating shaft bracket 23 respectively. The six groups of insulating sleeves 15 and angle adjustment devices are evenly distributed in a centripetal manner. The micro-stepping motor 41 can cause the stepping motor output shaft 17 to produce a vertical displacement, which is converted into a horizontal displacement through the guide plate connecting rod 19, driving the guide plate 21 to deflect, abutting against the insulating sleeve 15 and causing it to displace, thereby adjusting the bending angle of the insulating sleeve 15. In this process, the position state of the insulating sleeve 15 can be determined by the guide plate 21, and the problem of the sub-needle being offset by force when in contact with the tissue is solved. That is, the guide plate 21 can ensure that the insulating sleeve 15 and the sub-needle are prevented from displacement and shaking. In addition, the position state of the insulating sleeve 15 can be controlled by controlling the guide plate 21 to control the needle outlet angle of the sub-needle.

[0025] The side of the hollow electrode needle 1 is provided with a first arc-shaped electrode sheet 3 and a third arc-shaped electrode sheet 5 which are arranged opposite to each other. The side of the hollow electrode needle 1 is also provided with a second arc-shaped electrode sheet 4 and a fourth arc-shaped electrode sheet 6 which are arranged opposite to each other, and are used to form an ablation area around the hollow electrode needle 1. An insulating interlayer 7 is provided between the hollow electrode needle 1 and the first arc-shaped electrode sheet 3, the third arc-shaped electrode sheet 5, the second arc-shaped electrode sheet 4 and the fourth arc-shaped electrode sheet 6, and the inner wall of the hollow electrode needle 1 is covered with an inner insulating layer 8. The upper end of the insulating fixing column 16 is fixedly connected to the inner insulating layer 8 through a rod body or a connector. The insulating interlayer 7 is used to form a mutually insulated state. For complex anatomical areas, the insulating interlayer can prevent short circuits caused by contact between the electrode and surrounding tissues or liquids, ensure the precise conduction of current, and concentrate the energy in the target area to enhance the treatment effect. More importantly, the insulating layer can prevent the current from spreading to non-target areas and causing the risk of damage to healthy tissues.

[0026] One end surface of the first arc electrode sheet 3, the third arc electrode sheet 5, the second arc electrode sheet 4 and the fourth arc electrode sheet 6 is covered with an outer insulating layer 9. The outer side of the first arc electrode sheet 3, the third arc electrode sheet 5, the second arc electrode sheet 4 and the fourth arc electrode sheet 6 is covered with an outer insulating layer 9. The lower section of the first arc electrode sheet 3, the third arc electrode sheet 5, the second arc electrode sheet 4 and the fourth arc electrode sheet 6 is not covered with the outer insulating layer 9. The setting of the insulating layer 9 can control the action area to prevent the current from spreading to non-target areas and reduce damage to normal tissues. In addition, the insulating layer 9 can reduce the adhesion of the electrode needle to the surrounding tissues, reduce the difficulty of surgery and the risk of complications. When the sub-needle is not used, it will not affect the use of the mother needle as a single-needle ablation electrode alone; when the sub-needle is used, the sub-needle will penetrate the outer insulating layer 9 and enter the human tissue after passing through the lower end outlet of the insulating sleeve 15. The area where the first arc electrode sheet 3 does not cover the outer insulating layer 9 constitutes the first arc electrode sheet ablation zone 10, the area where the third arc electrode sheet 5 does not cover the outer insulating layer 9 constitutes the third arc electrode sheet ablation zone 12, the area where the second arc electrode sheet 4 does not cover the outer insulating layer 9 constitutes the second arc electrode sheet ablation zone 11, and the area where the fourth arc electrode sheet 6 does not cover the outer insulating layer 9 constitutes the fourth arc electrode sheet ablation zone 13. The first arc electrode sheet ablation zone 10 is opposite to the third arc electrode sheet ablation zone 12 and is incorrectly arranged up and down, and the second arc electrode sheet ablation zone 11 is opposite to the fourth arc electrode sheet ablation zone 13 and is incorrectly arranged up and down. The adjacent arc electrode sheet ablation zones are not located at the same level, which can achieve the expansion of the ablation coverage area, improve the ablation efficiency and range, and is suitable for tumors of different shapes and reduces omissions.

[0027] The end of the hollow electrode needle 1 has a hollow electrode needle tip ablation zone 14, and the surface of the hollow electrode needle tip ablation zone 14 is not covered with an outer insulating layer 9 to ensure ablation. A solid electrode needle 25 is arranged inside the sub-needle, and an arc-shaped sub-needle electrode sheet 26 is arranged outside the solid electrode needle 25. A sub-needle insulating interlayer 27 is distributed between the solid electrode needle 25 and the arc-shaped sub-needle electrode sheet 26, and a sub-needle outer insulating layer 28 is covered outside the sub-needle insulating interlayer 27. The setting of the sub-needle outer insulating layer 28 can control the action area to prevent the current from spreading to non-target areas, reduce damage to normal tissues, and the sub-needle outer insulating layer 28 can reduce the adhesion of the electrode needle to the surrounding tissues, reduce the difficulty of surgery and the risk of complications. The lower section of the arc-shaped sub-needle electrode sheet 26 is provided with an arc-shaped sub-needle electrode sheet ablation zone 29, and the surface of the arc-shaped sub-needle electrode sheet 26 is not covered by the sub-needle outer insulation layer 28; the lower section of the solid electrode needle 25 is provided with a solid electrode needle tip 31 and a solid electrode needle side ablation zone 30, and the solid electrode needle tip 31 and the solid electrode needle side ablation zone 30 are not covered by the sub-needle outer insulation layer 28.

[0028] The arc-shaped sub-needle electrode sheet ablation area 29 and the solid electrode needle side ablation area 30 are relatively staggered and are not located on the same horizontal plane. The upper sections of the solid electrode needle 25 and the arc-shaped sub-needle electrode sheet 26 are provided with arc-shaped thickened parts, which are the sub-needle outer contact sheet 32 ​​and the sub-needle inner contact sheet 33, respectively. The surfaces of the two are slightly higher than the surface of the sub-needle outer insulation layer 28, and are not covered with insulating materials to ensure good contact and electrical conductivity. The side surface of the sub-needle top is provided with a wedge tooth 34, which protrudes from the sub-needle surface, continues with the sub-needle outer insulation layer 28, and is located on the same side of the sub-needle inner contact sheet 33.

[0029] Embodiment 2: This embodiment provides a further improved solution based on the solution of embodiment 1, see attached Figure 6 , Attachment Figure 7 , Attachment Figure 8 As shown, the first arc-shaped electrode sheet ablation zone 10, the third arc-shaped electrode sheet ablation zone 12, the second arc-shaped electrode sheet ablation zone 11, and the fourth arc-shaped electrode sheet ablation zone 13 of the mother needle are arranged in pairs in an alternating manner, and the arc-shaped sub-needle electrode sheet ablation zone 29 and the solid electrode needle side ablation zone 30 of the sub-needle are arranged in a positive alternating manner. This design can ensure that each side ablation zone is not adjacent to another side ablation zone, increase the area of ​​the insulating layer between the side ablation zones, and reduce the risk of spark discharge between the two side ablation zones caused by current creeping along the surface of the insulating layer when the electrode needle is in human tissue.

[0030] See attached Figure 4 , Attachment Figure 3 , Attachment Figure 8 As shown, the hollow electrode needle 1, the first arc electrode sheet 3, the third arc electrode sheet 5, the second arc electrode sheet 4 and the fourth arc electrode sheet 6, the solid electrode needle 25, and the arc sub-needle electrode sheet 26 are made of metal materials with extremely high room temperature conductivity, good stiffness and toughness, and easy to process small inner diameter structures, such as tungsten copper alloy. This is mainly because the structure complexity and precision of the mother needle are relatively high, and the sub-needles also need to be bent at a certain angle without breaking. It is necessary to ensure the conductive performance while having good rigidity and deformability, and it is easy to manufacture small inner diameter pipes, metal sheets, etc. according to the processing technology.

[0031] The insulating interlayer 7, the inner insulating layer 8, the insulating sleeve 15, and the sub-pin insulating interlayer 27 have a room temperature conductivity less than or equal to 1x10 -12 S / m, with good anti-breakdown performance, good plasticity of polymer insulation, such as polytetrafluoroethylene, the purpose is to ensure the electrical insulation between the metal electrodes, to protect the high-voltage circuit and the pulse electric field generator; the outer insulating layer 9 and the outer insulating layer 28 of the sub-needle adopt room temperature conductivity less than or equal to 1x10 -11S / m, made of high molecular insulating material with good self-lubrication and biocompatibility, such as polyparaxylene, in order to reduce the resistance during the needle insertion operation and reduce the risk of allergies in patients; solid insulating fixed column 16, stepper motor output shaft 17, output shaft fixed tube 18, guide plate connecting rod 19, guide plate connecting rod fixed tube 20, guide plate 21, guide plate rotating shaft 22, rotating shaft bracket 23, fixed tube bracket 24, wedge tooth 34 adopt room temperature conductivity less than or equal to 1x10 -10 S / m, made of hard polymer insulating material with strong plasticity, such as epoxy resin. In this embodiment, the reference diameters of the mother needle and the daughter needle are 10mm-20mm and 1mm-5mm respectively. Considering that the thickness of each insulating layer and each arc electrode sheet can be less than 1mm in technology, the reference diameter of the hollow electrode needle 1 can be 8mm-18mm.

[0032] Embodiment 3: This embodiment provides a further improved solution based on the solution of embodiment 1, see attached Fig.25 , Attachment Figure 1 -Attached Figure 5 , Attachment Fig.10 -Attached Fig.16 As shown, a mother-and-child needle type pulsed electric field ablation electrode also includes a gripping portion, which includes a fixing portion 35 and a handle 36. Six insulating sleeves 15 are arranged inside the fixing portion 35, and the insulating sleeves 15 pass through the top of the hollow metal needle 1, bend outward and open at the top of the fixing portion 35, and a wedge groove 37 is provided next to the opening, which can fit with the wedge teeth 34 of the sub-needle. Six groups of angle adjustment devices are provided inside and outside the insulating sleeve 15, each group includes an inner bite wheel 38 and an outer bite wheel 39, the size of the inner bite wheel 38 is slightly smaller than the outer bite wheel 39, so as to facilitate arrangement and fixation; the insulating sleeve 15 is provided with a square opening at the angle adjustment device, so that the wheel surface of the inner bite wheel 38 and the outer bite wheel 39 are embedded in the insulating sleeve 15, so as to be in close contact with the inner contact piece 33 and the outer contact piece 32 of the sub-needle respectively and maintain electrical conduction; an outer bite wheel motor 47 is provided beside the outer bite wheel 39, which can control the rotation of the outer bite wheel 39 and adjust the insertion depth of the sub-needle. An additional insulating needle 40 is provided, which has the same diameter as the sub-needle, and the upper section is provided with the same wedge teeth 34, and the lower end is slightly lower than the lower ends of the inner contact piece 33 and the outer contact piece 32 of the sub-needle.

[0033] Since the wedge tooth 34 at the upper end of the sub-needle is fixed on the sub-needle and is on the same side as the inner contact piece 33 of the sub-needle, after the wedge tooth 34 is engaged with the wedge groove 37, it can ensure that the inner contact piece 33 of the sub-needle and the outer contact surface 32 of the sub-needle are in corresponding contact with the wheel surfaces of the inner bite wheel 38 and the outer bite wheel 39 respectively, avoiding the circuit from being connected due to the rotation of the sub-needle or the inaccurate insertion position when the operator inserts the sub-needle, thereby playing the role of a fool-proof design.

[0034] The insulating needle 40 can achieve the following: when the sub-needle is not in use, the inner interlocking wheel 38 and the outer interlocking wheel 39 are separated by the insulating needle 40, so as to solve the problem that the small distance between the wheel surfaces of the inner interlocking wheel 38 and the outer interlocking wheel 39 causes air breakdown and causes a short circuit. The insulating needle 40 has a wedge tooth 34 design similar to that of the sub-needle, and can also fit with the wedge groove 37, which is conducive to fixing it in the insulating sleeve 15.

[0035] The curved upper section of the insulating sleeve 15 provides space for placing the micro-stepping motor 41, and the micro-stepping motor 41 is controlled by the stepping motor wire 42. A first plug 43 and a second plug 44 are provided at the rear end of the handle 36, a first round button 45 and a second round button 46 are provided on the finger-fitting surface on the inner side below the handle 36, and a display screen is provided on the inner side above the handle 36, including a micro-control mainboard 48 and a liquid crystal screen 49, the micro-control mainboard 48 is equipped with a button battery 50, and an increase key 51, a decrease key 52, a third round button 53, and a fourth round button 54 are provided next to the display screen.

[0036] The first plug 43 and the second plug 44 are made of stainless steel and can be connected to the positive and negative electrodes of the pulse electric field generator respectively, and there is no strict correspondence between the positive and negative electrodes and the first plug 43 and the second plug 44 .

[0037] The wire connections between the structures in the grip are as follows: Figure 10-12 , Figure 21-Figure 25As shown. The microcontrol mainboard 48 is connected to the first circular button 45, the second circular button 46, the increase button 51, the decrease button 52, the third circular button 53, and the fourth circular button 54 by wires, and is connected to the micro-stepping motor 41 through the stepping motor wire 42. The inner bite wheel 38 and the outer bite wheel 39 are connected to the second plug 44 and the first plug 43 through the inner bite wheel wire 55 and the outer bite wheel wire 56 respectively, and the outer bite wheel motor 47 is connected to the microcontrol mainboard 48 through the sub-needle adjustment control line 57. The hollow electrode needle 1 is connected to the first plug 43 through the hollow electrode needle wire 58, and the hollow electrode needle wire 58 is provided with a first switch 59 and is mechanically controlled to open and close by the first circular button 45. The handle 36 is provided with a second switch group, including a first sub-switch 60, a second sub-switch 61, a third sub-switch 62, and a fourth sub-switch 63, which are respectively connected to the first arc electrode sheet 3, the second arc electrode sheet 4, the third arc electrode sheet 5, and the fourth arc electrode sheet 6 through the first arc electrode sheet wire 64, the second arc electrode sheet wire 65, the third arc electrode sheet wire 66, and the fourth arc electrode sheet wire 67, and are respectively connected to the micro-control main board 48 through the first sub-switch control line 68, the second sub-switch control line 69, the third sub-switch control line 70, and the fourth sub-switch control line 71. The two poles of each sub-switch of the second switch group are respectively connected to the first plug 43 and the second plug 44 through the first plug wire 72 and the second plug wire 73.

[0038] The wheel surfaces of the inner and outer interlocking wheels 38 and 39 are made of highly conductive and easily shaped metal materials, such as tungsten-copper alloy; the bodies of the inner and outer interlocking wheels 38 and 39 are made of insulating polymer materials with good anti-breakdown performance and good plasticity, such as polytetrafluoroethylene, in order to prevent short circuits between the metal wheel surfaces and the output shaft of the outer interlocking wheel motor 47; the fixing portion 35, the handle 36, the wedge groove 37, the first circular button 45, the second circular button 46, the increase button 51, the decrease button 52, the third circular button 53, and the fourth circular button 54 are made of engineering plastics; the handle 36 is designed in accordance with ergonomics to fit the user's grip curve; the microcontroller mainboard 48 and ... microcontroller mainboard 48 and the first circular button 45, the second circular button 46, the increase button 51, the decrease button 52, the third circular button 53, and the fourth circular button 54 are made of engineering plastics; the microcontroller mainboard 48 and the first circular button 45, the second circular button 46, the increase button 51, the decrease button 52, the third circular button 53, and the fourth circular button 54 are made of engineering plastics; the microcontroller mainboard 48 and the first circular button 45, the second circular button The wires connected to the key 52, the third circular key 53, and the fourth circular key 54, the stepping motor wire 42, the inner bite wheel wire 55, the outer bite wheel wire 56, the sub-needle adjustment control wire 57, the hollow electrode needle wire 58, the first arc electrode sheet wire 64, the second arc electrode sheet wire 65, the third arc electrode sheet wire 66, the fourth arc electrode sheet wire 67, the first sub-switch control wire 68, the second sub-switch control wire 69, the third sub-switch control wire 70, and the fourth sub-switch control wire 71 are all made of copper core silicone high-voltage wires; the first switch 59, the first sub-switch 60, the second sub-switch 61, the third sub-switch 62, and the fourth sub-switch 63 are all made of engineering plastics and copper; the first plug 43 and the second plug 44 are made of stainless steel.

[0039] An outer interlocking wheel motor 47 is provided beside the outer interlocking wheel 39 of the angle adjustment device to provide power for the outer interlocking wheel 39; the inner interlocking wheel 38 is a driven wheel. The wheel surfaces of the two interlocking wheels are metal contact surfaces, and the wheel surfaces are connected to the positive and negative poles of the pulse electric field through the inner interlocking wheel wire 55 and the outer interlocking wheel wire 56, that is, a strong circuit; the outer interlocking wheel motor 47 is connected to the micro-control mainboard 48 through the sub-needle adjustment control line 57, and it is powered by a button battery 50, which is a weak circuit. In addition, the detection circuit circuit of the opening and closing state of the first switch 59 and the first circular button 45 is separated, and the circuit of each arc electrode sheet wire of the second switch group and the sub-switch control line is separated, which are similar strong and weak circuit separation designs. Because the pulse electric field has the characteristics of instantaneous high voltage and strong pulse, this design is conducive to protecting the micro-control mainboard from breakdown, and enhancing the safety and effectiveness of the use of the present invention.

[0040] The first circular button 45 can directly mechanically control the opening and closing of the first switch 59. The opening and closing state of the first circular button 45 has a detection circuit. Each sub-switch of the second switch group is a digital control switch. The control line of each sub-switch bidirectionally transmits two types of data, namely, the state of the detection switch and the opening and closing of the control switch, and the data is processed by the micro-control main board 48. To solve the large difference in volume and metal exposure area between the hollow electrode needle 1 and the first arc electrode sheet 3, the second arc electrode sheet 4, the third arc electrode sheet 5, the fourth arc electrode sheet 6, the solid electrode needle 25, and the arc sub-needle electrode sheet 26, the pulse electric field energy flowing through the circuit of the hollow electrode needle 1 is greater, and the current density is higher, which poses a safety hazard. Using a mechanical switch to directly control the opening and closing of the circuit is conducive to improving the safety of the present invention.

[0041] The control and detection functions that can be realized by the micro-control main board 48 mainly include: 1) detecting the open and closed state of the first switch 59 controlled by the first circular button 45; 2) the second circular button 46 selects a sub-switch of the second switch group, and the increase key 51 and the decrease key 52 control whether the sub-switch is connected to the first plug 43 or the second plug 44; 3) the third circular button 53 selects an angle adjustment device, and the increase key 51 and the decrease key 52 adjust the corresponding sub-needle insertion angle; 4) the fourth circular button 54 selects an angle adjustment device, and the increase key 51 and the decrease key 52 adjust the corresponding sub-needle insertion depth.

[0042] The microcontroller mainboard 48 can control each electrode of the mother needle and the daughter needle to be connected to the positive or negative pole of the pulse electric field, and when using the daughter needle, all six daughter needles do not need to be inserted. The number and position of the daughter needles to be used can be freely selected according to the actual needs of tumor ablation, such as large blood vessels that cannot be avoided on the needle insertion path, and the combination of the daughter needles and the mother needle with different numbers and positions constitutes effective ablation areas of different shapes and sizes, so as to achieve high customization of pulse electric field ablation. When the first switch 59 is closed, the second switch group selects the first plug 43, and no daughter needle is used, the present invention can also be used as a traditional single-needle unipolar pulse electric field ablation electrode, that is, two or more ablation electrodes are parallel to each other, and the first plugs 43 of different electrodes are connected to the positive or negative pole of the pulse electric field, and after the traditional multi-electrode needle ablation is completed, the daughter needle is inserted without changing the position of the mother needle for supplementary ablation. This design can fully combine the advantages of the large ablation range of the traditional single-needle unipolar electrode with the advantages of the precise ablation of the single-needle bipolar electrode, further expanding the application prospects of the present invention.

[0043] It can be seen from the above embodiments that the present invention integrates the positive and negative electrodes of the pulsed electric field into the same electrode device, while adopting a mother-and-child needle design, which avoids the disadvantages of the traditional electrodes needing to be kept parallel to each other when used and the small ablation range of the existing single-needle electrodes, reduces the difficulty of operation, expands the effective ablation area of ​​the pulsed electric field, and improves the effectiveness and safety of tumor ablation. The present invention also integrates a numerical control circuit to achieve precise control of the insertion depth and angle of the sub-needle, and can individually select and control the connection between the mother needle and each electrode of the sub-needle and the positive or negative electrode of the pulsed electric field, and highly customize different effective ablation area shapes and sizes according to the actual situation of the tumor, which is conducive to the optimization of the formulation of the pulsed electric field ablation plan, and the present invention provides a traditional single-needle single-stage ablation mode, further expanding the application scenarios and scope of tumor ablation.

[0044] In this embodiment, the first arc-shaped electrode sheet ablation zone 10, the second arc-shaped electrode sheet ablation zone 11, the third arc-shaped electrode sheet ablation zone 12, and the fourth arc-shaped electrode sheet ablation zone 13 are relatively staggered in pairs, and the arc-shaped sub-needle electrode sheet ablation zone 29 and the solid electrode needle side ablation zone 30 are relatively staggered in distribution, which increases the creepage distance and reduces the risk of spark breakdown. The angle adjustment device is arranged at the lower section of the insulating sleeve 15, and the micro-stepping motor 41 arranged in the fixed part 35 pulls the guide plate connecting rod 19 through the stepping motor output shaft 17 to convert the vertical movement into horizontal movement, so that the guide plate 21 rotates to change the angle of the lower end outlet of the insulating sleeve 15; the angle adjustment device is arranged on the inner and outer sides of the upper section of the insulating sleeve 15, located in the fixed part 35, and the wheel surfaces of the inner side 38 and the outer side engaging wheel 39 protrude into the insulating sleeve 15 and fit with the inner side 33 of the sub-needle and the outer contact piece 32 to make the sub-needle electrically conductive, and the outer side engaging wheel motor 47 rotates the outer side engaging wheel 39 to change the depth of the sub-needle insertion. The two sets of devices are connected to the micro-control mainboard 48 located on the inner side above the handle 36 through wires, and are controlled by various buttons on the handle 36, which is conducive to accurately adjusting the insertion angle and depth of the sub-needle, and the micro-control mainboard 48 is independently powered by a button battery 50, realizing the separate design of the strong and weak circuits of the pulse circuit and the control circuit, effectively improving the accuracy and safety of pulse electric field ablation. A wedge groove 37 is provided next to the opening of the insulating sleeve 15 at the top of the fixing part 35, which can fit with the sub-needle wedge teeth 34 to fix its position, ensure that the sub-needle contact piece is correctly fitted with the wheel surface of the bite wheel, and is conducive to simplifying the doctor's operation; an insulating needle 40 with a wedge tooth 34 is also provided to physically insulate the two bite wheels when the sub-needle is not in use, which is conducive to preventing air breakdown and improving safety. The handle 36 is provided with a first switch 59 and a second switch group. Each sub-switches of the second switch group determine whether each arc-shaped electrode sheet is connected to the first 43 or the second plug 44, realizing the arbitrary connection of each electrode of the mother needle with the positive and negative poles of the pulsed electric field. Further combined with the adjustability of the number, depth and angle of the sub-needle insertion, the shape and size of the pulsed electric field ablation area can be customized in a diversified manner, which is conducive to optimizing the ablation scheme according to the actual situation of the tumor. This embodiment also provides that the first switch 59 is closed, and the second switch group selects the traditional single-needle unipolar ablation electrode mode of the first plug 43, and the traditional multi-needle parallel ablation is completed through the mutual cooperation of multiple electrodes of this embodiment, and the switch mode can be switched thereafter and the sub-needles can be used to further complete the expansion of ablation and precise ablation, which effectively retains the advantages of the traditional single-needle unipolar electrode with a large ablation range, while having the advantages of single-needle bipolar electrode ablation with precision and easy operation.

[0045] The insertion angle and depth of the sub-needles of the present invention can be precisely adjusted by the micro-control mainboard, so that sub-needles at different hole positions can be inserted into human tissue at different angles and depths, which is convenient for doctors to avoid important vascular structures under the assistance of ultrasound, accurately control the size of the ablation area, ensure full coverage of the tumor by the ablation area, and enhance the safety and effectiveness of pulsed electric field ablation therapy; The ablation electrode of the present invention realizes arbitrary connection between the positive and negative electrodes of the pulse electric field and the hollow electrode needles and the arc-shaped electrode sheets by controlling multiple switches and a micro-control mainboard, forming a variety of different types of combinations. Any combination corresponds to different ablation area shapes, and with different numbers of sub-needles, needle insertion depths, and needle insertion angles, a high degree of customization of the shape of the effective area of ​​pulse electric field ablation is achieved. Ablation can be performed without dead angles in the needle insertion area, which is conducive to specific analysis according to the actual situation of the tumor in clinical applications, and selection of the optimal ablation combination scheme; Embodiment 4: This embodiment is a further improvement on the basis of embodiment 1. Fig.25 As shown, a first groove 80 is provided on the upper and lower surfaces of the handle 36, and an airbag structure is built into the first groove 80 to fill the first groove 80, and medical gauze is provided on the surface to seal the first groove 80. The above-mentioned scheme is set to enable the handle 36 to better adapt to the palm of each person, the airbag structure can achieve a closer contact with the hand and there is a medical gauze interval between the airbag and the hand, which solves the problem of grip slippage, and the liquid on the operator's hand or glove can be collected by the medical gauze and temporarily stored in the space in the first groove 80, thereby reducing the problem of grip slippage caused by more liquid on the contact surface affecting the operation. In addition, the airbag structure and medical gauze in the first groove 80 can relatively absorb possible muscle tremors caused by hand gripping, thereby solving the problem of muscle tremors causing shaking of the handle 36.

[0046] This article uses specific examples to illustrate the principles and implementation methods of this application. The description of the above embodiments is only used to help understand the method and its core ideas of this application. The above is only the preferred implementation method of this application. It should be pointed out that due to the limitations of textual expression and the objective existence of infinite specific structures, ordinary technicians in this technical field can make several improvements, modifications or changes without departing from the principles of this application, and can also combine the above technical features in an appropriate manner; these improvements, modifications, changes or combinations, or the direct application of the concept and technical solution of the invention to other occasions without improvement, should be regarded as the scope of protection of this application.

Claims

1. A mother-and-child needle type pulsed electric field ablation electrode, comprising: A mother needle, wherein the mother needle has a hollow electrode needle (1) built therein, and the mother needle is provided with at least two needle outlet holes (2), wherein the needle outlet holes (2) are connected to the mother needle and the inside of the hollow electrode needle (1); The feature is that the hollow electrode needle (1) has at least two insulating sleeves (15) built in, the insulating sleeves (15) have sub-needles built in, and the sub-needles can be displaced relative to the needle hole (2).

2. The mother-and-child needle type pulsed electric field ablation electrode according to claim 1, characterized in that: The outlet end of the insulating sleeve (15) corresponds to the position of the needle outlet hole (2); an angle adjustment device is provided between the insulating sleeve (15) and the hollow electrode needle (1); the angle adjustment device comprises a guide plate (21) provided between the insulating sleeve (15) and the hollow electrode needle (1); one end of the guide plate (21) is hinged to a guide plate connecting rod (19); one end of the guide plate connecting rod (19) is hinged to a stepper motor output shaft (17); the stepper motor output shaft (17) is arranged parallel to the axis of the hollow electrode needle (1) and a micro stepper motor is connected to the end thereof.

3. The mother-and-child needle type pulsed electric field ablation electrode according to claim 2, characterized in that: An insulating fixing column (16) is provided at the center of the hollow electrode needle (1), a hollow track is provided in the middle section of the guide plate (21), a guide plate rotating shaft (22) is inserted into the hollow track, and the guide plate rotating shaft (22) is connected to the insulating fixing column (16) via a rotating shaft bracket (23).

4. The mother-and-child needle type pulsed electric field ablation electrode according to claim 1, characterized in that: The side surface of the hollow electrode needle (1) is provided with a first arc-shaped electrode sheet (3) and a third arc-shaped electrode sheet (5) arranged opposite to each other, and the side surface of the hollow electrode needle (1) is also provided with a second arc-shaped electrode sheet (4) and a fourth arc-shaped electrode sheet (6) arranged opposite to each other.

5. The mother-and-child needle type pulse electric field ablation electrode according to claim 4, characterized in that: An insulating interlayer (7) is provided between the hollow electrode needle (1) and the first arc-shaped electrode sheet (3), the third arc-shaped electrode sheet (5), the second arc-shaped electrode sheet (4) and the fourth arc-shaped electrode sheet (6), and the inner wall of the hollow electrode needle (1) is covered with an inner insulating layer (8).

6. The mother-and-child needle type pulse electric field ablation electrode according to claim 4, characterized in that: One end surface of the first arc-shaped electrode sheet (3), the third arc-shaped electrode sheet (5), the second arc-shaped electrode sheet (4) and the fourth arc-shaped electrode sheet (6) is covered with an outer insulating layer (9).

7. The mother-and-child needle type pulse electric field ablation electrode according to claim 6, characterized in that: The area of ​​the first arc-shaped electrode sheet (3) not covered by the outer insulating layer (9) constitutes a first arc-shaped electrode sheet ablation zone (10), the area of ​​the third arc-shaped electrode sheet (5) not covered by the outer insulating layer (9) constitutes a third arc-shaped electrode sheet ablation zone (12), the area of ​​the second arc-shaped electrode sheet (4) not covered by the outer insulating layer (9) constitutes a second arc-shaped electrode sheet ablation zone (11), and the area of ​​the fourth arc-shaped electrode sheet (6) not covered by the outer insulating layer (9) constitutes a fourth arc-shaped electrode sheet ablation zone (13). The first arc-shaped electrode sheet ablation zone (10) and the third arc-shaped electrode sheet ablation zone (12) are opposite to each other and are arranged incorrectly up and down, and the second arc-shaped electrode sheet ablation zone (11) and the fourth arc-shaped electrode sheet ablation zone (13) are opposite to each other and are arranged incorrectly up and down.

8. The mother-and-child needle type pulsed electric field ablation electrode according to claim 1, characterized in that: The end of the hollow electrode needle (1) is provided with a hollow electrode needle tip ablation zone (14), and the surface of the hollow electrode needle tip ablation zone (14) is not covered with an outer insulating layer (9).

9. The mother-and-child needle type pulsed electric field ablation electrode according to claim 1, characterized in that: A solid electrode needle (25) is arranged inside the sub-needle, an arc-shaped sub-needle electrode sheet (26) is arranged outside the solid electrode needle (25), a sub-needle insulating interlayer (27) is arranged between the solid electrode needle (25) and the arc-shaped sub-needle electrode sheet (26), and a sub-needle outer insulating layer (28) is covered outside the sub-needle insulating interlayer (27).

10. The mother-and-child needle type pulse electric field ablation electrode according to claim 9, characterized in that: The lower section of the arc-shaped sub-needle electrode sheet (26) is provided with an arc-shaped sub-needle electrode sheet ablation zone (29), and the surface of the arc-shaped sub-needle electrode sheet (26) is not covered by the sub-needle outer insulation layer (28); The lower section of the solid electrode needle (25) is provided with a solid electrode needle tip (31) and a solid electrode needle side ablation zone (30), and neither the solid electrode needle tip (31) nor the solid electrode needle side ablation zone (30) is covered by the sub-needle outer insulation layer (28).

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