WO2021022677A1 - 一种用于引导电极的穿刺针及电极输送装置 - Google Patents

一种用于引导电极的穿刺针及电极输送装置 Download PDF

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Publication number
WO2021022677A1
WO2021022677A1 PCT/CN2019/112447 CN2019112447W WO2021022677A1 WO 2021022677 A1 WO2021022677 A1 WO 2021022677A1 CN 2019112447 W CN2019112447 W CN 2019112447W WO 2021022677 A1 WO2021022677 A1 WO 2021022677A1
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Prior art keywords
electrode
sleeve
needle
puncture needle
parallel
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PCT/CN2019/112447
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English (en)
French (fr)
Inventor
陈永刚
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杭州睿笛生物科技有限公司
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Publication of WO2021022677A1 publication Critical patent/WO2021022677A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1477—Needle-like probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1487—Trocar-like, i.e. devices producing an enlarged transcutaneous opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3476—Powered trocars, e.g. electrosurgical cutting, lasers, powered knives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe

Definitions

  • the invention relates to the field of biological tissue ablation equipment, and more specifically to a puncture needle for guiding electrodes and an electrode delivery device.
  • the existing non-thermoelectric pulse ablation technology mainly exposes the diseased tissue through percutaneous puncture or open surgery to perform invasive electrical pulse ablation treatment on patients.
  • This invasive non-thermal ablation also has many problems that need to be solved urgently, such as: for tumors inside the patient's body (far away from the body surface), puncture operations or laparotomy are more traumatic to the patient, and some patients do not have any problems due to various physical reasons.
  • each puncture will produce a new perforation in the patient's body, which will undoubtedly increase the healing time of the patient's wound.
  • the technical problem to be solved by the present invention is to overcome the above-mentioned prior art and provide a puncture needle and an electrode delivery device for guiding electrodes, which can reduce the number of perforations, increase the electrode ablation area, shorten the operation time, and cause less trauma to the patient.
  • a puncture needle for guiding electrodes which is rotatably arranged in an outer sheath during use, and includes a sharp part at the front end for puncture, and A needle body located at the rear end for transporting the electrode assembly; an electrode guiding channel is arranged in the needle body, and the outlet of the electrode guiding channel is located on the side wall of the needle body.
  • the puncture needle is inserted into the preset ablation area, and then the ablation area is ablated by extending the electrode assembly in the puncture needle. Because the electrode assembly is from the puncture needle Extend laterally. After completing an ablation, the electrode assembly retracts, and the electrode assembly can be extended again for ablation by turning the puncture needle to a preset angle; compared with the existing scheme (the puncture needle setting and the electrode The head end, that is, the integrated arrangement), in the solution provided by the present invention, on a perforation formed by the puncture needle, the ablation area surrounds the perforation, which is not only large, but also less traumatic to the patient.
  • a further preferred solution of the present invention is that the angle formed between the outlet direction of the electrode guiding channel and the axis of the needle body is between 5 and 150 degrees.
  • the electrode assembly includes at least a pair of parallel electrode needles, the number of electrode guide channels is an even number, the outlet sections of the electrode guide channels are parallel to each other, and the electrode needles parallel to each other are located in the outlet section respectively.
  • the parallel electrodes guide the channel.
  • the parallel electrode needle includes a working section at the front end and an insulating section at the back end, the outer surface of the working section is coated with a weakening coating in the axial direction, and the conductive The coefficient is smaller than the conductivity coefficient of the working section. Since the two parallel electrode needles are discharging, the current always flows through the path of least resistance (that is, the closest path), and most of them are concentrated inside the parallel electrode needles
  • the weakened coating is a semiconductor material coating, including a diamond coating, a diamond-nickel-based composite coating, or a copper-diamond composite coating.
  • a further preferred solution of the present invention is that: when a pair of the parallel electrode needles are in discharge operation, the weakened coatings on the two parallel electrode needles are arranged opposite to each other and are located inside between the two.
  • a further preferred solution of the present invention is that: the end of the electrode assembly is connected with a pulse generator for releasing high-voltage nanosecond pulses; when the pulse generator releases high-voltage pulses, an electric field is formed on the two parallel electrode needles of the electrode assembly , The intensity of the electric field around one of the parallel electrode pins is greater than the intensity of the electric field around the other parallel electrode pins.
  • a further preferred solution of the present invention is that the angle formed between the outlet direction of the electrode guiding channel and the axis of the needle body is between 5 and 90 degrees, and the electrode assembly includes a needle electrode and a cylindrical electrode.
  • an electrode delivery device including a handle device and the above-mentioned puncture needle
  • the handle device includes an outer pin tube for fixing the electrode tube holder of the outer sheath tube, and is arranged at the front end of the electrode tube holder A sleeve and a rear sleeve, the front sleeve and the rear sleeve are movably arranged on the electrode tube seat, the front sleeve is connected with the puncture needle, and the rear sleeve is connected with the electrode assembly;
  • the puncture needle moves axially in the outer sheath or the electrode assembly moves in the electrode guide channel of the puncture needle;
  • the front end sleeve and the electrode tube holder rotate in the circumferential direction, the puncture needle and the outer sheath rotate synchronously.
  • a further preferred solution of the present invention is: the end of the needle body is connected with a tubular booster, the booster is arranged in the outer sheath; the front end sleeve is connected with the puncture needle through the booster; the electrode assembly is provided There are a push tube and a wire located in the push tube and used for connecting the electrode, the push tube is located in the needle body or the booster, and the rear end sleeve is connected to the electrode assembly through the push tube.
  • a further preferred solution of the present invention is that the front end sleeve is sleeved on the electrode tube holder, the outer wall of the electrode tube holder is provided with a first guide groove, and the front end sleeve passes through the first guide sleeve provided at the front end and the first guide Slot sliding connection.
  • a further preferred solution of the present invention is that: the rear end of the front sleeve is provided with an adjustment handle, and the adjustment handle and the front sleeve are arranged to rotate in a circumferential direction.
  • a further preferred solution of the present invention is that the rear end sleeve is sleeved on the adjustment handle, the outer wall of the adjustment handle is provided with a second guide groove, and the rear end sleeve passes through the second guide sleeve provided at the front end and the second guide Slot sliding connection.
  • a further preferred solution of the present invention is that: the outer side wall of the electrode tube holder or the adjusting handle is further provided with a scale line, and the front end sleeve or the rear end sleeve is provided with an observation hole for controlling the displacement by observing the scale line.
  • a further preferred solution of the present invention is that the rear end of the front sleeve is provided with a pinball lock, the outer side wall of the adjustment handle is provided with an annular boss, and the annular boss is provided with a plurality of pinball locks. Lock hole; the front end of the adjustment handle is placed in the front sleeve and the front end of the adjustment handle is provided with a handle nut, the handle nut cooperates with the annular boss, and the adjustment handle and the front end sleeve are in the axial upper limit.
  • a further preferred solution of the present invention is that: the front sleeve or the rear sleeve is also provided with a radial screw hole, and the screw hole is provided for fastening the front sleeve with the electrode tube holder, or for fixing the back end The locking screw for fastening the sleeve and the adjusting handle.
  • the present invention has the following beneficial effects: 1.
  • the ablation area can be enlarged by only one puncture hole; 2.
  • the trauma to the patient is small and the healing time of the patient's wound is shortened.
  • Fig. 1 is a schematic structural diagram of Example 1, showing the internal structure of a puncture needle.
  • Example 2 is a cross-sectional view of the puncture needle of Example 1 along the radial direction of the needle body.
  • Fig. 3 is an enlarged view of B in Fig. 2.
  • FIG. 4 is a schematic diagram of the structure of parallel electrode needles in Embodiment 1.
  • FIG. 4 is a schematic diagram of the structure of parallel electrode needles in Embodiment 1.
  • Figures 5-8 are diagrams of the position state when the puncture needle of embodiment 1 is used in a scene.
  • Fig. 9 is a diagram of the position state when the puncture needle of embodiment 1 is used in scene two.
  • Figure 10 is a diagram of the position state when the puncture needle of Example 1 is used in scene three
  • Example 11 is a diagram showing the distribution of electric field lines in the radial direction at the moment when the parallel electrode needles of Example 1 are connected to positive and negative voltages respectively.
  • Embodiment 12 is a schematic diagram of the structure of Embodiment 2.
  • FIG. 13-14 are schematic diagrams of the cross-sectional structure of Embodiment 2 at different angles along the axial direction.
  • Fig. 15 is an enlarged view of C in Fig. 14.
  • 16-17 are the front view of the pinball lock and the front view of the lock hole in the second embodiment, respectively.
  • Marking instructions 1. Puncture needle; 11. Sharp part; 12. Needle body; 13. Electrode guide channel; 14. Booster; 2. Outer sheath; 3. Electrode assembly; 31. Parallel electrode needle; 311. Work Section; 312. Insulation section; 313. Weakened coating; 32. Push tube; 33. Fixing part; 34. Wire; 35. Electrode crimp socket; 4. Electrode tube holder; 41. First guide groove; 5. Front end Sleeve; 51. First guide sleeve; 52. Pinball lock; 6. Adjust handle; 61. Second guide groove; 62. Annular boss; 63. Key hole; 64. Handle nut; 7. Rear sleeve 71. Second guide sleeve; 8. Observation hole; 9. Locking screw.
  • Example 1 As shown in Figures 1 and 2 (Figure 1 is a cross-sectional view at A in Figure 2), the present invention provides a puncture needle 1 for guiding electrodes, which is rotatably disposed in the outer sheath during use 2 includes a sharp portion 11 at the front end for puncture, and a needle body 12 at the rear end for transporting the electrode assembly 3.
  • the needle body 12 is provided with an electrode guide channel 13, and the outlet of the electrode guide channel 13 is located on the side wall of the needle body 12.
  • the angle formed between the outlet direction of the electrode guide channel 13 and the axis of the needle body 12 is between 5 and 150 degrees. In this embodiment, the angle formed between the outlet direction of the electrode guide channel 13 and the axis of the needle body 12 is 45 degrees.
  • the electrode assembly 3 includes at least a pair of parallel electrode needles 31, the number of electrode guide channels 13 is an even number, and the number of electrode guide channels 13 corresponds to the number of parallel electrode needles 31 or the number of electrode guide channels 13 is greater than the number of parallel electrode needles 31 quantity.
  • the outlet sections of the electrode guiding channel 13 are parallel to each other in pairs, and the electrode needles that are parallel to each other are respectively located in the electrode guiding channel 13 whose outlet sections are parallel.
  • a pair of parallel electrode needles 31 is used as an example.
  • the outlets of the electrode guide channels 13 are arranged in sequence in the axial direction of the needle body 12
  • the outlets of the electrode guiding channel 13 can also be arranged in other arrangements.
  • the parallel sections of the electrode guiding channel 13 are on the same plane and the cross section formed between the needle bodies 12 is circular or elliptical by the plane.
  • the parallel electrode needle 31 includes a working section 311 at the front end and an insulating section 312 at the back end.
  • the outer surface of the working section 311 is coated with a weakening coating 313 in the axial direction.
  • the conductivity is smaller than that of the working section 311.
  • the two parallel electrode needles 31 are discharging, the electric field intensity between the two parallel electrode needles 31 near the inner side and near the electrode needles is the largest, and the electric field intensity around the electrode needles is weak. Therefore, in the process of working (ablation), in order to achieve more ablation In a large range, a larger voltage amplitude needs to be input to reach the destruction pulse threshold of the surrounding tumor, which will increase the possibility of breakdown of the inner sides of the two opposed electrodes. Therefore, by coating the weakening coating 313 on the parallel electrode needles 31, and allowing the weakening coating 313 on the two parallel electrode needles 31 to face each other, located on the inner side between the two, it can weaken the gap between the two during discharge. The internal conductivity reduces the possibility of breakdown.
  • the weakened coating 313 is a semiconductor material coating, and may be a diamond coating, a diamond-nickel-based composite coating, or a copper-diamond composite coating.
  • the end of the electrode assembly 3 is connected with a pulse generator for releasing high-voltage nanosecond pulses.
  • a pulse generator for releasing high-voltage nanosecond pulses.
  • an electric field is formed on the two parallel electrode needles 31 of the electrode assembly 3.
  • the intensity of the electric field around one parallel electrode needle 31 is greater than the electric field intensity around the other parallel electrode needle 31 (the two electric fields can be the same Or vice versa, when the direction of the electric field is opposite, see Figure 11).
  • Different intensities of electric fields and alternating effects are generated on the two parallel electrode needles 31 to achieve different coverage effects.
  • the electrode assembly 3 may also adopt a structure of needle poles and cylindrical poles.
  • the barrel pole is hollow, and the needle pole is located inside the barrel pole.
  • the discharge end of the hand extreme part exposes the barrel pole.
  • the needle pole moves in the electrode guide channel 13 together with the barrel pole and protrudes from the outlet of the side wall of the needle body 12.
  • the specific structure Refer to the existing design and will not be detailed here.
  • the electrode assembly 3 adopts the structure of the needle electrode and the cylindrical electrode, the angle formed between the outlet direction of the electrode guide channel 13 and the axis of the needle body 12 is between 5 and 90 degrees.
  • an electrode delivery device includes a handle device and the puncture needle 1 in embodiment 1.
  • the handle device includes an outer sheath tube 2, an electrode tube holder 4 for fixing the outer sheath tube 2, a front end sleeve 5 and a rear end sleeve 7 arranged on the electrode tube holder 4, a front end sleeve 5 and a rear end sleeve 7
  • the electrode tube holder 4 is movably arranged, the front sleeve 5 is connected with the puncture needle 1, and the rear sleeve 7 is connected with the electrode assembly 3.
  • the puncture needle 1 moves axially in the outer sheath 2 or the electrode assembly 3 moves in the electrode guide channel 13 of the puncture needle 1.
  • the puncture needle 1 and the outer sheath 2 rotate synchronously.
  • a tubular booster 14 is connected to the end of the needle body 12.
  • the booster 14 has a certain degree of flexibility and bendable, and is arranged in the outer sheath 2.
  • the front end sleeve 5 is connected with the puncture needle 1 through the booster 14.
  • the electrode assembly 3 is provided with a push tube 32 and a wire 34 located in the push tube 32 and used to connect the electrode.
  • the push tube 32 is located in the needle body 12 or the booster 14, and one end of the push tube 32 is parallel to the electrode through a fixing member 33.
  • the end of the electrode needle 31 is connected, and the rear end sleeve 7 is connected with the electrode assembly 3 through the other end of the push tube 32.
  • the end of the rear sleeve 7 is provided with an electrode crimping socket 35, and the electrode crimping socket 35 connects the wire 34 with an external pulse generator (used to release high-voltage nanosecond pulses).
  • a stopper can be provided on the outer wall of the push tube 32, and a guide groove can be provided on the inner wall of the electrode guide channel 13. The cooperation of the stopper and the guide groove prevents the parallel electrode from being in the electrode guide channel 13 The inner circumference rotates.
  • the front end sleeve 5 is sleeved on the electrode tube holder 4, the outer wall of the electrode tube holder 4 is provided with a first guide groove 41, and the front end sleeve 5 is slidably connected to the first guide groove 41 through a first guide sleeve 51 provided at the front end.
  • the rear end of the front sleeve 5 is provided with an adjusting handle 6, and the adjusting handle 6 and the front sleeve 5 are arranged to rotate in a circumferential direction.
  • the rear end sleeve 7 is sleeved on the adjustment handle 6, the outer wall of the adjustment handle 6 is provided with a second guide groove 61, and the rear end sleeve 7 is slidably connected to the second guide groove 61 through a second guide sleeve 71 provided at the front end.
  • the rear end of the front sleeve 5 is provided with a pinball lock 52
  • the outer side wall of the adjustment handle 6 is provided with an annular boss 62
  • the annular boss 62 is provided with a ball lock 52 that is adapted to
  • four lock holes 63 are taken as an example, and the adjustment angle is 90°.
  • the front end of the adjustment handle 6 is placed in the front sleeve 5 and the front end of the adjustment handle 6 is provided with a handle nut 64.
  • the handle nut 64 cooperates with the annular boss 62 to place the adjustment handle 6 and the front sleeve 5 in the axial upper limit position. .
  • the outer wall of the electrode tube holder 4 or the adjusting handle 6 is also provided with scale lines, and the front sleeve 5 or the rear sleeve 7 is provided with an observation hole 8 for controlling displacement by observing the scale lines.
  • a diameter is also opened on the front end sleeve 5 or the rear end sleeve 7.
  • a locking screw 9 is arranged in the screw hole.
  • both the front sleeve 5 and the rear sleeve 7 are provided with screw holes and locking screws 9, and the locking screws 9 are the first locking screw and the second locking screw in sequence.
  • Example 1 The use process of Example 1 and Example 2 is as follows:
  • the parallel electrode needle 31 can be retracted after step 6, the puncture needle 1 is further deepened, and then the parallel electrode needle 31 is extended again for ablation.
  • Scene one corresponds to Figure 5-8
  • scene two corresponds to Figure 9 (the puncture needle and parallel electrode needle avoid the dense neurovascular area)
  • scene three corresponds to Figure 10 (for human Pipes, inner wall areas of organs).

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Abstract

一种用于引导电极的穿刺针（1），在使用时可转动的配置在外鞘管（2）中，包括位于前端用于穿刺的尖锐部（11），以及位于后端用于输送电极组件的针体（12）；针体（12）内设有电极引导通道（13），电极引导通道（13）的出口位于针体（12）侧壁上；能够减少穿孔次数，增加电极消融区域，缩短手术时间，对患者的创伤少。

Description

一种用于引导电极的穿刺针及电极输送装置 技术领域
本发明涉及生物组织消融设备领域，更具体地说是一种用于引导电极的穿刺针及电极输送装置。
背景技术
现有非热电脉冲消融技术，主要通过经皮穿刺或手术开腹暴露病变组织，对患者进行有创的电脉冲消融治疗。这种有创非热消融亦存在很多亟待解决的问题，如：对患者身体内部(远离体表)的肿瘤，穿刺操作或开腹对患者创伤较大，并且有些患者由于身体各种原因，不适合或不能承受大创伤手术，而经皮穿刺在控制上又很难通过一次穿刺(这里的一次穿刺是只在体内产生一个穿孔)就将肿瘤完全消融，通常需要多次穿刺，每次穿刺消融后需要调整穿刺位置，以便多次穿刺能够将肿瘤完全覆盖。
而多次穿刺不仅增加了手术时间，而且每次穿刺会在患者体内产生新的穿孔，则无疑也会增加患者伤口的愈合时间。
发明内容
本发明所要解决的技术问题是克服上述现有技术中，提供一种用于引导电极的穿刺针及电极输送装置，能够减少穿孔次数，增加电极消融区域，缩短手术时间，对患者的创伤少。
为实现上述目的，本发明目的其一通过以下技术方案得以实现：一种用于引导电极的穿刺针，在使用时可转动的配置在外鞘管中，包括位于前端用于穿刺的尖锐部，以及位于后端用于输送电极组件的针体；所述针体内设有电极引导通道，所述电极引导通道的出口位于针体侧壁上。
采用上述技术方案，将外鞘管放置到指定位置时，通过穿刺针刺入预设消融区域，再通过伸出穿刺针内的电极组件，对消融区域进行消融，由于电极组件是从穿刺针的侧向伸出，在完成一次消融后，电极组件缩回，只需转动穿刺针一个预设角度，即可再次伸出电极组件进行消融；相比于现有的方案(穿刺针设置与电极的首端，即一体化设置)，本发明提供的方案，穿刺针所形成的一个穿孔上，消融区域围绕穿孔，不仅大，而且对患者的创伤小。
本发明进一步优选方案为：所述电极引导通道的出口朝向与针体轴线之间所成的夹角在5至150度之间。
本发明进一步优选方案为：所述电极组件至少包括一对平行电极针，所述电极引导通道的数量为偶数个，电极引导通道的出口段两两相互平行，相互平行的电极针分别位于出口段相平行的电极引导通道内。
本发明进一步优选方案为：所述平行电极针包括位于前端的工作段和位于后端的绝缘段，所述工作段的外表面在沿轴向上涂覆弱化涂层，所述弱化涂层的导电系数小于工作段的导电系数。由于两平行电极针在放电时，电流总是流经电阻最小的路径(也即最近的路径)，大部分都集中在平行电极针内侧
本发明进一步优选方案为：所述弱化涂层为半导体材料涂层，包括金刚石镀层、金刚石镍基复合镀层，或者铜-金刚石复合镀层。
本发明进一步优选方案为：一对所述的平行电极针在放电工作时，两平行电极针上的弱化涂层相向设置，位于两者之间的内侧。
本发明进一步优选方案为：所述电极组件的末端连有用于释放高压纳秒脉冲的脉冲发生器；在所述脉冲发生器释放高压脉冲时，所述电极组件的两平行电极针上形成一电场，其中一平行电极针周围的电场的强度大于另一平行电极针周围的电场强度。
本发明进一步优选方案为：所述电极引导通道的出口朝向与针体轴线之间所成的夹角在5至90度之间，所述电极组件包括针极和筒极。
本发明的另一目的在于提供一种电极输送装置，包括手柄装置和上述的穿刺针；所述手柄装置包括外销管，用于固定外鞘管的电极管座，设于电极管座上的前端套筒和后端套筒，所述前端套筒与后端套筒均可移动的设置电极管座上，所述前端套筒与穿刺针连接，所述后端套筒与电极组件相连接；所述前端套筒或所述后端套筒在沿电极管座的轴向上移动时，所述穿刺针在外鞘管中轴向移动或所述电极组件在穿刺针的电极引导通道内移动；所述前端套筒与电极管座周向转动时，所述穿刺针与外鞘管中同步转动。
本发明进一步优选方案为：所述针体的末端连有管状的助推件，助推件设置在外鞘管内；所述前端套筒通过助推件与穿刺针相连接；所述电极组件上设有推管和位于推管中且用于连接电极的导线，所述推管位于针体或助推件内，所述后端套筒与通过推管与电极组件相连。
本发明进一步优选方案为：所述前端套筒套设在电极管座上，电极管座的外壁设有第一导向槽，所述前端套筒通过设置于前端的第一导向套与第一导向槽滑动连接。
本发明进一步优选方案为：所述前端套筒的后端设有调节手柄，所述调节手柄与前端套筒周向转动设置。
本发明进一步优选方案为：所述后端套筒套设在调节手柄上，调节手柄的外壁设有第二导向槽，所述后端套筒通过设置于前端的第二导向套与第二导向槽滑动连接。
本发明进一步优选方案为：所述电极管座或调节手柄的外侧壁上还设有刻度线，所述前端套筒或后端套筒上开有用于通过观察刻度线来控制位移的观察孔。
本发明进一步优选方案为：所述前端套筒的后端设有弹珠锁，所述调节手柄的外侧壁上设有环形凸台，环形凸台上设有与弹珠锁适配的多个锁孔；所述调节手柄的前端部置于前端套筒内且调节手柄的前端设有手柄螺母，所述手柄螺母和环形凸台相配合，将调节手柄与前端套筒在轴向上限位。
本发明进一步优选方案为：所述前端套筒或后端套筒上还开有径向的螺孔，螺孔内设有用于将前端套筒与电极管座紧固，或者用于将后端套筒与调节手柄紧固的锁紧螺钉。
综上所述，本发明具有以下有益效果；一、仅通过一个穿刺孔就能增大消融区域；二、对患者的创伤小，缩短患者伤口的愈合时间。
附图说明
图1是实施例1的结构示意图，示出了穿刺针的内部结构。
图2是实施例1的穿刺针在沿针体径向的剖面图。
图3是图2中B处的放大图。
图4是实施例1中平行电极针的结构示意图。
图5-8是在场景一下使用实施例1的穿刺针时的位置状态图。
图9是在场景二下使用用实施例1的穿刺针时的位置状态图。
图10是在场景三下使用用实施例1的穿刺针时的位置状态图
图11是实施例1的平行电极针分别连接正、负电压瞬间，在径向上的电场线分布图。
图12是实施例2的结构示意图。
图13-14是实施例2在沿其轴向上不通角度的剖面结构示意图。
图15是图14中C处的放大图。
图16-17分别是实施例2中弹珠锁的正视图与锁孔的正视图。
标记说明：1、穿刺针；11、尖锐部；12、针体；13、电极引导通道；14、助推件；2、外鞘管；3、电极组件；31、平行电极针；311、工作段；312、绝缘段；313、弱化涂层；32、推管；33、固定件；34、导线；35、电极压接插座；4、电极管座；41、第一导向槽；5、前端套筒；51、第一导向套；52、弹珠锁；6、调节手柄；61、第二导向槽；62、环形凸台；63、锁孔；64、手柄螺母；7、后端套筒；71、第二导向套；8、观察孔；9、锁紧 螺钉。
具体实施方式
以下结合附图对本发明作进一步详细说明。
本实施例仅仅是对本发明的解释，其并不是对本发明的限制，本领域技术人员在阅读完本说明书后可以根据需要对本实施例做出没有创造性贡献的修改，但只要在本发明的权利要求范围内都受到专利法的保护。
实施例1：如图1和2所示(图1是图2中A处的截面图)，本发明提供了一种用于引导电极的穿刺针1，在使用时可转动的配置在外鞘管2中，包括位于前端用于穿刺的尖锐部11，以及位于后端用于输送电极组件3的针体12。
针体12内设有电极引导通道13，电极引导通道13的出口位于针体12侧壁上。电极引导通道13的出口朝向与针体12轴线之间所成的夹角在5至150度之间。在本实施例中电极引导通道13的出口朝向与针体12轴线之间所成的夹角在45度。
电极组件3至少包括一对平行电极针31，电极引导通道13的数量为偶数个且电极引导通道13的数量与平行电极针31的数量一一对应或者电极引导通道13的数量大于平行电极针31的数量。电极引导通道13的出口段两两相互平行，相互平行的电极针分别位于出口段相平行的电极引导通道13内。在本实施例中，以一对平行电极针31举例说明，当电极引导通道13的数量大于平行电极针31时(电极引导通道13的出口于针体12轴向上依次排列)，根据实际需要，将平行电极针31放入相应的电极引导通道13内，以便控平行电极针31之间的距离。除此之外，电极引导通道13的出口还可以是其他的排列，电极引导通道13平行段所在同一平面上且该平面将针体12之间形成的截面为圆形或椭圆形。
如图2-4所示，平行电极针31包括位于前端的工作段311和位于后端的绝缘段312，工作段311的外表面在沿轴向上涂覆弱化涂层313，弱化涂层313的导电系数小于工作段311的导电系数。
由于两平行电极针31在放电时，两平行电极针31之间靠近内侧及电极针附近的电场强度最大，电极针外周电场强度较弱，因此在工作(消融)的过程中，为了达到消融更大的范围，需要输入更大的电压幅值，才能达到周围肿瘤的毁损脉冲阀值，这样就导致两相对电极的内侧被击穿的可能性增大。因此通过在平行电极针31上涂覆弱化涂层313，并且让两平行电极针31上的弱化涂层313相向设置，位于两者之间的内侧，使其在放电时能削弱两者之间内侧的导电性，进而减小被击穿的可能。本实施例中，弱化涂层313为半导体材料涂层，可采用金刚石镀层、金刚石镍基复合镀层，或者铜-金刚石复合镀层。
电极组件3的末端连有用于释放高压纳秒脉冲的脉冲发生器。在脉冲发生器释放高压脉冲时，电极组件3的两平行电极针31上形成一电场，其中一平行电极针31周围的电场的强度大于另一平行电极针31周围的电场强度(两电场可以相同或相反，电场方向相反时，详见图11)。通过在两平行电极针31上产生不同强度的电场和交替作用，以达到不同的覆盖效果。
电极组件3除了上述采用平行电极针31的结构外，还可以采用针极和筒极的结构。筒极中空，针极位于筒极内，在使用时针极端部的放电端露出筒极，针极随筒极一同于电极引导通道13内移动并从针体12侧壁的出口伸出，具体结构参考现有设计，此处不再详述。电极组件3采用针极和筒极的结构时，电极引导通道13的出口朝向与针体12轴线之间所成的夹角在5至90度之间。
实施例2：如图12-14所示，一种电极输送装置，包括手柄装置和实施例1中的穿刺针1。手柄装置包括外鞘管2，用于固定外鞘管2的电极管座4，设于电极管座4上的前端套筒5和后端套筒7，前端套筒5与后端套筒7均可移动的设置电极管座4上，前端套筒5与穿刺针1连接，后端套筒7与电极组件3相连接。前端套筒5或后端套筒7在沿电极管座4的轴向上移动时，穿刺针1在外鞘管2中轴向移动或电极组件3在穿刺针1的电极引导通道13内移动。前端套筒5与电极管座4周向转动时，穿刺针1与外鞘管2中同步转动。
针体12的末端连有管状的助推件14，助推件14具有一定的柔韧度、可弯曲，设置在外鞘管2内。前端套筒5通过助推件14与穿刺针1相连接。电极组件3上设有推管32和位于推管32中且用于连接电极的导线34，推管32位于针体12或助推件14内，推管32的一端通过一固定件33与平行电极针31的末端连接，后端套筒7与通过推管32的另一端与电极组件3相连。后端套筒7的末端设有电极压接插座35，电极压接插座35将导线34与外接的脉冲发生器(用于释放高压纳秒脉冲)相连。
为了防止平行电极在电极引导通道13内自转，可在推管32外壁设置限位件，在电极引导通道13内壁设置引导槽，通过限位件与引导槽的配合防止平行电极在电极引导通道13内周向转动。
前端套筒5套设在电极管座4上，电极管座4的外壁设有第一导向槽41，前端套筒5通过设置于前端的第一导向套51与第一导向槽41滑动连接。
前端套筒5的后端设有调节手柄6，调节手柄6与前端套筒5周向转动设置。
后端套筒7套设在调节手柄6上，调节手柄6的外壁设有第二导向槽61，后端套筒7通过设置于前端的第二导向套71与第二导向槽61滑动连接。在本实施例中，前端套筒5 的后端设有弹珠锁52，调节手柄6的外侧壁上设有环形凸台62，环形凸台62上设有与弹珠锁52适配的多个锁孔63，调节角度与锁孔63数量相关。如图15-17所示，在本实施例中以4个锁孔63举例说明，其调节角度为90°。调节手柄6的前端部置于前端套筒5内且调节手柄6的前端设有手柄螺母64，手柄螺母64和环形凸台62相配合，将调节手柄6与前端套筒5在轴向上限位。
电极管座4或调节手柄6的外侧壁上还设有刻度线，前端套筒5或后端套筒7上开有用于通过观察刻度线来控制位移的观察孔8。
为了在移动后将电极管座4与前端套筒5轴向固定、或者将后端套筒7与电极管座4轴向固定，在前端套筒5或后端套筒7上还开有径向的螺孔，螺孔内设有一锁紧螺钉9。在本实施例中，前端套筒5和后端套筒7上均设有螺孔和锁紧螺钉9，锁紧螺钉9依次为第一锁紧螺钉和第二锁紧螺钉。
实施例1及实施例2的使用过程如下：
1、将前端套筒5和后端套筒7均向后移动至最大位置，并拧紧第一锁紧螺钉9和第二锁紧螺钉9，确保平行电极针31全部处在穿刺针1的电极引导通道13内以及穿刺针1全部在外鞘管2内。
2、将前端输送部(外鞘管2及外销管内的穿刺针1、电极组件3等)通过内镜通道(譬如超声内镜或ERCP钳道)抵达治疗区附近，将手柄装置固定在内镜通道上。
3、松开第一锁紧螺钉，推动前端套筒5，(通过助推件14)推出穿刺针1，并刺入肿瘤，可通过前端套筒5上的观察孔8观察刻度线上的数值，以便控制穿刺深度，进一步可通过超声影像显示并确认穿刺针1位置，拧紧第一锁紧螺钉，定位穿刺位置。
4、松开第二锁紧螺钉，推动后端套筒7，推出一对平行电极针31，通过电极引导通道13进入肿瘤，可通过后端套筒7上的观察孔8观察后刻度线上的数值，以便控制穿入深度，可通过超声影像显示并确认电极位置，拧紧第二锁紧螺钉，定位电极位置。
5、从电极压接插座35引入高压纳秒脉冲至平行电极针31上，进行肿瘤消融。通过影像显示，控制消融治疗过程。
6、依据消融手术方案，需多次脉冲消融的，移动后端套筒7使平行电极针31退回穿刺针1的电极引导通道13内，通过旋转调节手柄6一定角度(30度、45度、60度)或任意事先设定的角度，使穿刺针1自转相应的角度，调整电极出口方向，再次重复上述步骤3-5，以此达到在不增加穿刺孔的情况下达到增加电场覆盖范围，加强脉冲消融治疗效果的目的。
7、根据消融区域的需要，可在步骤6后退回平行电极针31，将穿刺针1进一步深入后再次伸出平行电极针31进行消融。
参见图5-10，具体使用场景大致有3种，场景一对应图5-8，场景二对应图9(穿刺针与平行电极针避开神经血管密集区)，场景三对应图10(针对人体管道、器官内壁区域)。

Claims (10)

  1. 一种用于引导电极的穿刺针，其特征在于，包括位于前端用于穿刺的尖锐部，以及位于后端用于输送电极组件的针体；所述针体内设有电极引导通道，所述电极引导通道的出口位于针体侧壁上。
  2. 根据权利要求1所述的穿刺针，其特征在于：所述电极组件至少包括一对平行电极针，所述电极引导通道的数量为偶数个，电极引导通道的出口段两两相互平行，相互平行的电极针分别位于出口段相平行的电极引导通道内。
  3. 根据权利要求2所述的穿刺针，其特征在于：所述平行电极针包括位于前端的工作段和位于后端的绝缘段，所述工作段的外表面在沿轴向上涂覆弱化涂层，所述弱化涂层的导电系数小于工作段的导电系数；一对所述的平行电极针在放电工作时，两平行电极针上的弱化涂层相向设置，位于两者之间的内侧。
  4. 根据权利要求2-3中任一项所述的穿刺针，其特征在于：所述电极组件的末端连有用于释放高压纳秒脉冲的脉冲发生器；在所述脉冲发生器释放高压脉冲时，所述电极组件的两平行电极针上形成一电场，其中一平行电极针周围的电场的强度大于另一平行电极针周围的电场强度。
  5. 根据权利要求1所述的穿刺针，其特征在于：所述电极引导通道的出口朝向与针体轴线之间所成的夹角在5至90度之间，所述电极组件包括针极和筒极。
  6. 一种电极输送装置，其特征在于：包括手柄装置和如权利要求1-5中任一项所述的穿刺针；所述手柄装置包括外销管，用于固定外鞘管的电极管座，设于电极管座上的前端套筒和后端套筒，所述前端套筒与后端套筒均可移动的设置电极管座上，所述前端套筒与穿刺针连接，所述后端套筒与电极组件相连接；所述前端套筒或所述后端套筒在沿电极管座的轴向上移动时，所述穿刺针在外鞘管中轴向移动或所述电极组件在穿刺针的电极引导通道内移动；所述前端套筒与电极管座周向转动时，所述穿刺针与外鞘管中同步转动。
  7. 根据权利要求6所述的电极输送装置，其特征在于：所述针体的末端连有管状的助推件，助推件设置在外鞘管内；所述前端套筒通过助推件与穿刺针相连接；所述电极组件上设有推管和位于推管中且用于连接电极的导线，所述推管位于针体或助推件内，所述后端套筒与通过推管与电极组件相连。
  8. 根据权利要求7所述的电极输送装置，其特征在于：所述前端套筒套设在电极管座上，电极管座的外壁设有第一导向槽，所述前端套筒通过设置于前端的第一导向套与第一导向槽滑动连接。
  9. 根据权利要求8所述的电极输送装置，其特征在于：所述前端套筒的后端设有调节手 柄，所述调节手柄与前端套筒周向转动设置；所述前端套筒的后端设有弹珠锁，所述调节手柄的外侧壁上设有环形凸台，环形凸台上设有与弹珠锁适配的多个锁孔；所述调节手柄的前端设置于前端套筒内且调节手柄的前端设有手柄螺母，所述手柄螺母和环形凸台相配合，将调节手柄与前端套筒在轴向上限位。
  10. 根据权利要求9所述的电极输送装置，其特征在于：所述后端套筒套设在调节手柄上，调节手柄的外壁设有第二导向槽，所述后端套筒通过设置于前端的第二导向套与第二导向槽滑动连接。
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