WO2005087123A1 - Radio-frequency ablation electrode - Google Patents

Radio-frequency ablation electrode Download PDF

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Publication number
WO2005087123A1
WO2005087123A1 PCT/CN2005/000279 CN2005000279W WO2005087123A1 WO 2005087123 A1 WO2005087123 A1 WO 2005087123A1 CN 2005000279 W CN2005000279 W CN 2005000279W WO 2005087123 A1 WO2005087123 A1 WO 2005087123A1
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needle
sub
radio frequency
frequency ablation
ablation electrode
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PCT/CN2005/000279
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French (fr)
Chinese (zh)
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Hongkui Wang
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Hongkui Wang
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B18/1477Needle-like probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00059Material properties
    • A61B2018/00071Electrical conductivity
    • A61B2018/00083Electrical conductivity low, i.e. electrically insulating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1405Electrodes having a specific shape
    • A61B2018/1425Needle
    • A61B2018/143Needle multiple needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1405Electrodes having a specific shape
    • A61B2018/1425Needle
    • A61B2018/1432Needle curved
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1475Electrodes retractable in or deployable from a housing

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

A Radio-frequency ablation electrode for treatment of tumors comprises a needle tip (11), sub needles (12), a needle stem (14) and a handle (18). Thermal couples (120) are attached to the tips of the sub needles( 12) and gear clusters (26, 27) are located inside of the handle (18) for winding the sub needles (12). The tips of the sub needles (12) are conductive, and the other parts of the sub needles (12), the needle tip (11) and the needle stem (14) are coated with insulation layers. The sub needles can be fully deployed to form an ellipsoid whose longest diameter is no less than 5 cm. The length of the handle can be less than 10 cm.

Description

射频消融电极  Radio frequency ablation electrode
技术领域 Technical field
本发明涉及射频消融电极,特别是能实时而精确地测出肿瘤边缘各点的治疗 温度的多极射频肿瘤消融电极。 技术背景  The invention relates to a radiofrequency ablation electrode, in particular a multipolar radiofrequency tumor ablation electrode capable of measuring the treatment temperature at each point on the edge of a tumor in real time and accurately. technical background
目前, 国内外已有的多极射频肿瘤消融电极可分两大类: 一类是不装测温传 感器的, 这类消融电极由于它无法控温, 在临床中电极的表面会结痂炭化, 造成 取针困难; 另一类消融电极虽有测温热偶, 但测温点很少 (最多只有 5点), 因 此也不能实时监测肿瘤边缘各点的治疗温度。 而肿瘤边缘的癌细胞是最活跃的, 如果不能实时准确地测出肿瘤边缘各点的治疗温度,医生就不能确切知道治疗的 效果, 因此也不能确定是否需要进行其它后续治疗。  At present, there are two types of multi-polar radiofrequency tumor ablation electrodes at home and abroad: one is not equipped with a temperature measurement sensor. Since this type of ablation electrode cannot control the temperature, the surface of the electrode will be carbonized in clinic. This makes needle removal difficult; although another type of ablation electrode has a thermocouple for temperature measurement, the temperature measurement points are few (up to 5 points), so the treatment temperature at various points on the edge of the tumor cannot be monitored in real time. The cancer cells at the edge of the tumor are the most active. If the treatment temperature at each point of the edge of the tumor cannot be accurately measured in real time, the doctor cannot know the effect of the treatment accurately, and therefore cannot determine whether other follow-up treatments are needed.
另外,目前对直径大于 4厘米的大肿块的治疗,如果采用射频消融针刺治疗, 必须采用多靶点叠加方法, 这种做法往往会遗漏部分病灶, 使治疗不彻底。解决 这一难题的最好方法是增大消融直径的单靶点治疗,但这要增大消融源的输出功 率, 这对患者和电磁兼容是很不利的。 因此, 如何能在不增加消融源输出功率的 情况下, 使消融直径增大是射频消融治疗急待解决的一大难题。  In addition, for the treatment of large masses larger than 4 cm in diameter, if radiofrequency ablation acupuncture is used, a multi-target superposition method must be used. This method often misses some lesions and makes the treatment incomplete. The best way to solve this problem is to increase the ablation diameter by single target treatment, but this will increase the output power of the ablation source, which is very detrimental to the patient and electromagnetic compatibility. Therefore, how to increase the ablation diameter without increasing the output power of the ablation source is a major problem to be solved urgently in radiofrequency ablation treatment.
例如:美国专利 US6, 379, 353B1公开了用多个电极治疗组织的装置和方法, 它使电极在插入到组织前以及插入到组织中时能保持均匀分布的外形,从而能够 均匀地加热组织。该发明的装置为加热并消融组织的探针系统, 该系统包括一根 套管, 该套管具有可在套管中往复运动的多个电极组件。该装置的电极具有弹性 记忆能力, 当电极被推出到套管外时它们呈径向向外的弓形外形。这些电极按照 均匀的周向间隔收在一个环形包壳中,该包壳由一个位于套管内腔中的中心件的 外表面和套管内腔的内表面限定出来, 如此, 由于电极被中心件和套管限位, 所 以, 在插入到组织中时能相对保持插入前的排列形式, 从而使得电极相对均匀地 分布在组织中。该专利改善了电极进入组织中时的分布情况, 但并没有涉及治疗 过程中电极是否能有效杀死癌细胞的问题。 再如, 中国发明专利申请公开 CN1525839A (对应国际公布 W02002/089686)披露了名称为 "RF组织消融设备和 方法"的发明。 其要解决的技术问题是消融不彻底、 消融体积较小及组织干燥和 炭化或消融时间延长, 为此, 该发明提出利用导电性增强溶液输送电磁能量, 以 产生比通常手段快、大和一致的消融体积。并且尽量解决电极周围的组织对注入 腔的堵塞问题。 其设备包括多个 RF消融电极和多个传感器元件, 每个电极可在 要消融的组织中展开或收回。在设备中的一个控制件可操作地连接到电极上, 用 来把 RF功率供给到电极, 以产生从个别电极消融区域前进以填充一个组合电极 消融体积的组织消融。电极是空心针形电极,经该电极将导电液体注入到组织中。 传感器元件是细长的, 用来通过测量组织的阻抗、通过测量组织的温度或通过测 量组织的光学性能来确定组织消融程度。但该发明不能实时监测肿瘤边缘的治疗 温度。 For example, U.S. Patent No. 6,379,353B1 discloses a device and method for treating tissue with multiple electrodes, which enables the electrodes to maintain a uniformly distributed shape before and during insertion into the tissue, thereby enabling uniform heating of the tissue. The device of the present invention is a probe system for heating and ablating tissue. The system includes a cannula having a plurality of electrode assemblies capable of reciprocating in the cannula. The electrodes of the device have an elastic memory capability, and when the electrodes are pushed out of the sleeve, they have a radially outward bow shape. The electrodes are housed in an annular cladding at even circumferential intervals, the cladding being defined by the outer surface of a central piece located in the inner cavity of the sleeve and the inner surface of the inner cavity of the sleeve. The sleeve is limited, so when it is inserted into the tissue, it can relatively maintain the arrangement form before insertion, so that the electrodes are relatively uniformly distributed in the tissue. The patent improves the distribution of the electrodes when they enter the tissue, but does not address the issue of whether the electrodes can effectively kill cancer cells during treatment. As another example, Chinese Invention Patent Application Publication CN1525839A (corresponding to International Publication WO2002 / 089686) discloses an invention named "RF tissue ablation device and method". The technical problems to be solved are incomplete ablation, small ablation volume, and tissue drying and carbonization or prolonged ablation time. To this end, the invention proposes to use a conductivity-enhancing solution to deliver electromagnetic energy to produce a faster, larger and consistent solution than usual methods. Ablation volume. And try to solve the problem of blocking the injection cavity by the tissue around the electrode. Its equipment includes multiple RF ablation electrodes and multiple sensor elements, each of which can be deployed or retracted in the tissue to be ablated. A control in the device is operatively connected to the electrode and is used to supply RF power to the electrode to produce advancement from the individual electrode ablation area to fill a combined electrode Ablation volume of tissue ablation. The electrode is a hollow needle electrode through which a conductive liquid is injected into the tissue. The sensor element is slender and is used to determine the degree of tissue ablation by measuring the impedance of the tissue, by measuring the temperature of the tissue, or by measuring the optical properties of the tissue. However, the invention cannot monitor the treatment temperature of the tumor edge in real time.
另外, 目前已有的消融电极的操作手柄过长, 特别当增长子针展开长度(增 大消融直径) 时, 操作手柄还要加长, 这样, 当用 CT引导进行治疗时, 那些肥 胖的患者就不能进入 CT窗内, 因此, 缩短消融电极操作手柄的长度是很有意义 的。 发明内容  In addition, the operation handles of existing ablation electrodes are too long, especially when increasing the expanded length of the sub-needle (increasing the ablation diameter), the operation handles must be lengthened. In this way, when CT-guided treatment is used, those obese patients will It cannot enter the CT window, so it is meaningful to shorten the length of the ablation electrode operation handle. Summary of the invention
针对上述现有的技术缺点, 特提出本发明以实现下列目的:  In view of the foregoing shortcomings of the prior art, the present invention is specifically proposed to achieve the following objectives:
提供一种消融直径大而所需射频源输出功率更小的消融电极,该消融电极的 子针完全展开能构成长直径不小于 5厘米的扁球形,最大的扁球形长直径可达到 12 厘米。 因此可对大肿瘤仅一次消融而无遗漏。 并且还能根据肿块的形状和肿 块所处的位置,将子针分成两组分别展开并调节子针展开的长度,从而能进行"适 形"治疗。  An ablation electrode with a large ablation diameter and smaller required RF source output power is provided. The abdomen needle of the ablation electrode is fully deployed to form a spheroid with a diameter of not less than 5 cm, and the largest spheroid has a diameter of 12 cm. Therefore, large tumors can be ablated only once without omission. And according to the shape and location of the mass, the sub-needle can be divided into two groups and deployed separately to adjust the length of the sub-needle deployment, so that "conformal" treatment can be performed.
提供一种操作手柄纵向长度小于 10cm的消融电极, 以便能对肥胖患者用 CT 引导进行穿刺和治疗。  An ablation electrode with a longitudinal length of the operation handle of less than 10 cm is provided in order to allow CT guided puncture and treatment of obese patients.
另外在对患者的射频消融治疗过程中,能实时地测出肿瘤边缘各点的治疗温 度 (测温点的距离可小于 lcm)。 为术后疗效评估提供科学依据。 如果肿瘤边缘 某处有较犬血管, 在血管附近的治疗温度有可能达不到治疗温度, 但医生知道了 这种情况后, 可以制定出其它后续治疗方案, 这也是很重要的。  In addition, during the radiofrequency ablation treatment of the patient, the treatment temperature of each point on the edge of the tumor can be measured in real time (the distance between the temperature measurement points can be less than lcm). Provide scientific basis for the evaluation of postoperative efficacy. If there is a canine blood vessel somewhere on the edge of the tumor, the treatment temperature near the blood vessel may not reach the treatment temperature, but after the doctor knows this, it is possible to work out other follow-up treatment plans, which is also very important.
为实现上述目的, 本发明提供一种射频消融切缘电极, 其包括针尖、 子针、 针杆、 操作手柄、 引线电缆和多芯插头,当所有子针完全展开后构成长直径不小 于 5厘米的扁球形。  To achieve the above object, the present invention provides a radio frequency ablation incision electrode, which includes a needle tip, a sub-needle, a needle rod, an operating handle, a lead cable and a multi-core plug. When all the sub-needle are fully deployed, the long diameter is not less than 5 cm. Oblate.
优选地, 上述多枚子针分为相等或不相等的两组, 两组子针的末端绕在操作 手柄内左右两只内齿轮外缘的窄槽内。  Preferably, the plurality of sub-needle is divided into two groups of equal or unequal, and the ends of the two sub-needle are wound in the narrow grooves of the outer edges of the left and right internal gears in the operation handle.
上述内齿轮内还可设有小齿轮, 小齿轮的轴上装有旋钮。  A pinion can also be set in the internal gear, and a knob is mounted on the pinion's shaft.
还可在上述内齿轮的外缘设有防胀环或梯形链条。  An anti-swelling ring or a trapezoidal chain can also be provided on the outer edge of the internal gear.
优选地, 针尖和针杆之间隔开, 形成子针导向缝, 两组子针从子针导向缝分 别或同时展开或收回。  Preferably, the needle tip and the needle bar are spaced apart to form a sub-needle guide seam, and the two sets of sub-needles are unfolded or retracted separately or simultaneously from the sub-needle guide seam.
此外, 在操作手柄上还可装子针导向缝调节钮, 它调节子针导向缝的宽度。 优选地, 所有子针的尖端都装有测温热偶。  In addition, a sub-needle guide seam adjusting knob can be installed on the operation handle, which adjusts the width of the sub-needle guide seam. Preferably, the tips of all the sub-needles are equipped with a thermocouple.
而且, 所有子针的尖端有 1-3厘米是导电的, 子针的其他部分和针尖、 针杆 上都有绝缘层。 Moreover, 1-3 cm of the tips of all the sub-needle is conductive, the other parts of the sub-needle and the needle tip, the needle bar There are insulation layers on it.
另外, 操作手柄上还装有如钟表形的子针展开长度刻度盘和指针。 附图说明  In addition, the operation handle is also equipped with a clock-shaped sub-hand extended length dial and pointer. BRIEF DESCRIPTION OF THE DRAWINGS
下面结合附图进一步对本发明作详细说明。 附图中:  The present invention will be further described in detail below with reference to the accompanying drawings. In the drawings:
图 1 表示了按照本发明第一个实施例的射频消融切缘电极子针展开后的外 形图;  FIG. 1 shows an outer shape of a radio frequency ablation electrode with a cutting edge needle expanded according to a first embodiment of the present invention;
图 2 表示了按照本发明第一个实施例的射频消融切缘电极的操作手柄的剖 视图;  FIG. 2 shows a cross-sectional view of an operating handle of a radio frequency ablation edge electrode according to a first embodiment of the present invention;
图 3表示了按照本发明第一个实施例的针尖与针尖连杆及接线柱的剖视图; 图 4表示了按照本发明第一个实施例的子针与测温热偶的组合图; 图 5表示了按照本发明第一个实施例的子针导向缝调节钮工作状态的图; 图 6表示了按照本发明第一个实施例的子针导向缝调节钮的剖视图; 图 7表示了按照本发明第一个实施例的塞子的剖视图;  Fig. 3 shows a sectional view of a needle tip, a needle tip link and a terminal post according to the first embodiment of the present invention; Fig. 4 shows a combined view of a sub-needle and a temperature measuring thermocouple according to the first embodiment of the present invention; Fig. 5 Fig. 6 shows a working state of the sub-needle guide seam adjusting button according to the first embodiment of the present invention; Fig. 6 shows a sectional view of the sub-needle guide seam adjusting button according to the first embodiment of the present invention; A cross-sectional view of the plug of the first embodiment of the invention;
图 8表示了按照本发明第一个实施例的针杆固定柱的剖视图;  8 shows a cross-sectional view of a needle bar fixing post according to a first embodiment of the present invention;
图 9表示了按照本发明第一个实施例的防胀环的外形图;  Fig. 9 shows an external view of an anti-swelling ring according to a first embodiment of the present invention;
图 10表示了按照本发明第一个实施例的基板的结构图;  FIG. 10 shows a structural diagram of a substrate according to a first embodiment of the present invention;
图 11表示了按照本发明第一个实施例的操作手柄的结构图;  FIG. 11 shows a structural diagram of an operation handle according to a first embodiment of the present invention;
图 12表示了按照本发明第二个实施例的射频消融切缘电极子针展开后的外 形图;  FIG. 12 shows an external view of a radio frequency ablation edge electrode sub-needle according to a second embodiment of the present invention after it is deployed;
图 13表示了按照本发明第二个实施例的射频消融切缘电极的操作手柄的剖 视图;  FIG. 13 shows a cross-sectional view of an operating handle of a radio frequency ablation edge electrode according to a second embodiment of the present invention;
图 14表示了按照本发明第二个实施例的射频消融切缘电极针杆的外形图; 图 15表示了按照本发明第二个实施例的射频消融切缘电极针尖、 注药管及 注药嘴的组件图;  FIG. 14 shows the outline of a needle electrode rod for a radio frequency ablation cutting edge electrode according to a second embodiment of the present invention; FIG. 15 shows a needle point, a medicine injection tube and a drug injection for a radio frequency ablation cutting edge electrode according to a second embodiment of the present invention Component drawing of mouth;
图 16表示了按照本发明第二个实施例的射频消融切缘电极子针、 测温热偶 和多芯插头的组合结构图;  FIG. 16 shows a combined structural diagram of a radio frequency ablation cutting edge electrode needle, a temperature measuring thermocouple, and a multi-core plug according to a second embodiment of the present invention;
图 17表示了按照本发明第二个实施例的射频消融切缘电极子针导向缝调节 钮的工作状态图;  FIG. 17 shows a working state diagram of a guide slit adjustment button for a radiofrequency ablation incision edge electrode needle according to a second embodiment of the present invention; FIG.
图 18表示了按照本发明第二个实施例的射频消融切缘电极子针导向缝调节 钮的剖视图;  FIG. 18 shows a cross-sectional view of a needle guide slit adjustment button of a radio frequency ablation incision edge electrode according to a second embodiment of the present invention;
图 19表示了按照本发明第二个实施例的射频消融切缘电极齿轮基板的结构 图;  19 is a structural diagram of a radio frequency ablation edge electrode gear substrate according to a second embodiment of the present invention;
图 20 表示了按照本发明第二个实施例的射频消融切缘电极内齿轮的结构 图; FIG. 20 shows the structure of an internal gear of a radio frequency ablation edge electrode according to a second embodiment of the present invention Figure;
图 21 表示了按照本发明第二个实施例的射频消融切缘电极小齿轮的结构 图;  FIG. 21 shows a structure diagram of a radio frequency ablation edge electrode pinion according to a second embodiment of the present invention;
图 22表示了按照本发明第二个实施例的射频消融切缘电极的梯形链条图; 图 23表示了按照本发明第二个实施例的射频消融切缘电极梯形链条外导轨 的结构图;  FIG. 22 shows a trapezoidal chain diagram of a radio frequency ablation cutting edge electrode according to a second embodiment of the present invention; FIG. 23 shows a structural diagram of an outer guide rail of a radio frequency ablation cutting edge electrode trapezoidal chain according to a second embodiment of the present invention;
图 24表示了按照本发明第二个实施例的射频消融切缘电极操作手柄壳体的 结构图。  Fig. 24 shows a structure diagram of a radio frequency ablation edge electrode operation handle housing according to a second embodiment of the present invention.
所有图中, 相同标号表示相同或类似的组件或部件。 图中所使用的标号如 下:  Throughout the drawings, the same reference numerals indicate the same or similar components or parts. The symbols used in the figure are as follows:
1 :射频消融切缘电极 18 操作手柄  1: RF ablation incision electrode 18 Operation handle
7 齿轮基板 181 操作手柄外壳  7 Gear base 181 Operating handle housing
9 防胀环 182 针杆座  9 Anti-swell ring 182 Needle bar seat
11 针尖 183 引线柱  11 Needle tip 183 Lead post
111 针尖头 184 半圆孔  111 Needle tip 184 Semi-circular hole
112 针尖孔 19 注药嘴  112 Needle tip hole 19 Injection nozzle
113 针尖末端 20 引线电缆  113 Tip Tip 20 Lead Cable
12 子针 21 多芯插头  12 sub-pins 21 multi-pin plug
120 测温热偶 22 针尖连杆  120 Thermocouple 22 Needle Tip Link
121 测温热偶引线 23 "Z"形架  121 Thermocouple Lead 23 "Z" Frame
122 子针末端 24 空芯螺钉  122 Sub-pin end 24 Cannulated screws
13 子针导向缝 25 齿轮基板  13 Needle guide slot 25 Gear base plate
14 针杆 251 小齿轮轴孔  14 Needle bar 251 Pinion shaft hole
140 针尖连杆 252 内齿轮轴孔  140 Needle link 252 Internal gear shaft hole
141 针杆外套 253 针杆外套固定孔  141 Needle bar cover 253 Needle bar cover fixing hole
142 针杆外套远端 26 内齿轮  142 Needle bar outer end 26 Internal gear
143 针尖连杆固定块 261 窄槽  143 Needle link fixing block 261 Narrow groove
145 针杆固定柱 262 子针末端固定孔  145 Needle bar fixing post 262 Needle end fixing hole
146 针杆外套近端 27 小齿轮  146 Needle bar housing proximal 27 Pinion
15 子针导向缝调节钮 28 梯形链条  15 Needle guide adjustment knob 28 Trapezoidal chain
151 通用螺母 281 防胀条  151 Universal nut 281 Anti-swell bar
152 旋钮颈部 282 柔性线  152 knob neck 282 flexible line
16 旋钮 29 梯形链条防胀环  16 knobs 29 trapezoidal chain anti-swell ring
17 子针展开长度刻度盘 291 内齿轮中心轴孔 171 指针 292 内齿轮胶合槽 17 Sub-needle extended length dial 291 Internal gear center shaft hole 171 Pointer 292 Internal gear gluing groove
30 中齿轮  30 medium gear
具体实施方式 detailed description
下面首先结合图 1-图 11详细地说明按照本发明第一个实施例的射频消融电 极。本发明的射频消融电极在治疗肿瘤时主要是将肿瘤边缘灭活,而不是把整个 肿瘤切除。  First, a radio frequency ablation electrode according to a first embodiment of the present invention will be described in detail with reference to Figs. When the radiofrequency ablation electrode of the present invention is used to treat a tumor, the tumor edge is mainly inactivated, rather than the entire tumor is removed.
如图 1所示,按照本发明第一个实施例的射频消融切缘电极 1主要包括:针 尖 11, 子针 12, 针杆 14, 子针导向缝调节钮 15, 操作手柄 18, 引线电缆 20和 多芯插头 21。其中子针 12可以是多枚, 比如 6— 14枚; 图中所示的多芯插头 21 为两只, 但可以根据实际情况改变其个数。  As shown in FIG. 1, the radio frequency ablation edge electrode 1 according to the first embodiment of the present invention mainly includes: a needle tip 11, a sub needle 12, a needle rod 14, a sub needle guide slit adjustment button 15, an operation handle 18, and a lead cable 20和 Multicore plug 21. The number of the sub-pins 12 may be multiple, such as 6-14. The multi-core plug 21 shown in the figure is two, but the number can be changed according to the actual situation.
针尖 11可用不锈钢制成, 针尖头 111一般做成圆锥形或三棱针形。 该针尖 11的作用是经皮刺入肿瘤组织。 需要说明的是, 圆锥形针尖头 111对病人造成 的损伤更小, 做肺肿瘤治疗时不易产生气胸。  The needle tip 11 may be made of stainless steel, and the needle tip 111 is generally formed into a conical or triangular needle shape. The function of the needle tip 11 is to percutaneously penetrate the tumor tissue. It should be noted that the conical needle tip 111 causes less damage to the patient, and it is not easy to produce pneumothorax when treating lung tumors.
如图 2所示, 6— 14枚子针 12的近端分成左右两组分别绕在操作手柄 18内 左右两只内齿轮 26外缘的窄槽内。为防止子针 12展开过程中向外胀开脱离内齿 轮 26的外缘, 在两个内齿轮 26的外面又设有防胀环 9, 如图 9和图 10所示, 防胀环 9可与基板 7固定在一起, 防胀环 9的缺口可使子针 12的近端向针杆 14 展开或收回。  As shown in FIG. 2, the proximal ends of the 6 to 14 needles 12 are divided into two groups of left and right, which are respectively wound in the narrow grooves in the outer edges of the left and right internal gears 26 in the operating handle 18. In order to prevent the sub-needle 12 from expanding outward from the outer edge of the internal gear 26 during the deployment process, an anti-swell ring 9 is provided on the outside of the two internal gears 26. As shown in FIGS. 9 and 10, the anti-swell ring 9 may Fixed with the base plate 7, the notch of the anti-swelling ring 9 enables the proximal end of the sub-needle 12 to be unfolded or retracted to the needle bar 14.
如图 2所示, 在每只内齿轮 26内都设有同样的三只小齿轮 27, 和一只中齿 轮 30, 中齿轮 30的作用是使两只内齿轮 26相互咬合, 从而使左右两组子针 12 可同时展开或收回。 在中间的小齿轮 27的轴上装有旋钮 16和指针 171。 如果要 使左右两组子针 12分别展开或收回, 则要去掉中齿轮 30, 左右两只中间小齿轮 27轴的端部分别装旋钮 16和指针 171。子针展开操作手柄 18上装有如钟.表形的 子针展开长度刻度盘 17和指针 171。  As shown in FIG. 2, each of the internal gears 26 is provided with the same three small gears 27 and a middle gear 30. The function of the middle gear 30 is to engage the two internal gears 26 with each other, so that the left and right two The group needle 12 can be expanded or retracted at the same time. A knob 16 and a pointer 171 are mounted on the shaft of the middle pinion 27. If the left and right sub-pins 12 are to be unfolded or retracted separately, the middle gear 30 is to be removed, and the ends of the two shafts of the left and right middle pinions 27 are equipped with a knob 16 and a pointer 171, respectively. The sub-needle deployment operation handle 18 is provided with a clock-shaped, watch-shaped sub-needle deployment length dial 17 and a pointer 171.
如图 3所示, 针尖 11、 连杆 140通过焊接、 黏结等多种方式固定到针尖连 杆固定块 143上。针尖连杆 140可以使用不锈钢管制成。引线柱 183由绝缘材料 制成, 在其中心两侧可设置小圆孔 154, 以便放置热偶引线 121和射频信号的传 输线。  As shown in FIG. 3, the needle tip 11 and the connecting rod 140 are fixed to the needle tip connecting rod fixing block 143 by various methods such as welding and bonding. The needle tip link 140 may be made of a stainless steel tube. The lead post 183 is made of an insulating material, and small circular holes 154 can be provided on both sides of the center, so as to place the thermocouple lead 121 and the transmission line of the radio frequency signal.
图 4示出了子针 12的详细结构: 子针 12内有测温热偶 120和引线 121, 测 温热偶 120位于子针 12的尖端。 可以将 6— 14枚子针 12焊接在一起。 子针 12 的横截面为中空圆形时, 圆形的外径应略小于针杆外套 141 的内径。 热偶引线 121经过引线柱 183引出并与多芯插头 21相连。 在本实施例中, 子针 12上只有 装测温热偶 120的 1一 3厘米是导电的, 子针 12的其它部分和针尖 11、 针杆 14 上都有绝缘涂层。 当 6— 14枚子针 12完全展开时, 子针 12的尖端到针杆 14的 距离均小于 2厘米, 从而能构成扁球形。 这样可在操作手柄 18的纵向长度小于 10厘米的情况下, 也能使子针 12展开的长度大于 7厘米。 因此, 当所有子针 12 完全展开后, 能构成长直径不小于 5厘米的扁球形。 FIG. 4 shows a detailed structure of the sub-needle 12: The sub-needle 12 includes a temperature measuring thermocouple 120 and a lead 121, and the temperature measuring thermocouple 120 is located at the tip of the sub-needle 12. 6-14 sub-pins 12 can be welded together. When the cross section of the sub-pin 12 is a hollow circle, the outer diameter of the circle should be slightly smaller than the inner diameter of the needle bar jacket 141. The thermocouple lead 121 is led out through a lead post 183 and is connected to the multi-core plug 21. In this embodiment, only 1 to 3 cm of the temperature measuring thermocouple 120 on the sub-needle 12 is conductive, and other parts of the sub-needle 12 and the needle tip 11 and the needle bar 14 are provided with an insulating coating. When 6-14 sub-needles 12 are fully deployed, the tip of the sub-needle 12 reaches the The distances are less than 2 cm, so they can form oblate spheres. In this case, when the longitudinal length of the operation handle 18 is less than 10 cm, the length of the sub-needle 12 can be extended to be more than 7 cm. Therefore, when all the sub-pins 12 are fully unfolded, they can form oblate spheres with a length of not less than 5 cm.
如图 1、 图 5和图 8所示, 针杆 14由针杆外套 141构成, 通过针杆固定柱 145固定到引线柱 183上。 如图 8所示, 将针杆固定柱 145内部制成螺紋孔, 用 于与下文所述的子针导向缝调节钮 15相连接。  As shown in FIG. 1, FIG. 5, and FIG. 8, the needle bar 14 is composed of a needle bar jacket 141 and is fixed to the lead post 183 through a needle bar fixing post 145. As shown in FIG. 8, the inside of the needle bar fixing post 145 is made into a threaded hole for connecting with the sub-needle guide slit adjusting button 15 described below.
如图 5和图 6所示, 子针导向缝调节钮 15由一中空螺钉构成, 该螺钉拧到 针杆固定柱 145的内螺纹孔中。 由图 5可见, 在针杆 14外有一段加粗管 23。 如 图 5和图 7所示, 该加粗管 23的下端用塞子 22螺钉的下口塞紧, 因此针杆 14 可通过导向缝调节钮 15上下移动, 因此能调节子针导向缝 13的大小。  As shown in FIG. 5 and FIG. 6, the sub-needle guide seam adjusting button 15 is composed of a hollow screw that is screwed into the internally threaded hole of the needle bar fixing post 145. It can be seen from FIG. 5 that there is a thickened tube 23 outside the needle bar 14. As shown in FIG. 5 and FIG. 7, the lower end of the thickened tube 23 is plugged with the lower mouth of the plug 22 screw, so the needle bar 14 can be moved up and down by the guide slot adjustment button 15, so the size of the sub-needle guide slot 13 can be adjusted. .
如图 1、 图 2和图 11所示, 操作手柄 18包括: 旋钮 16, 子针展开长度刻度 盘 17, 指针 171和多个齿轮 27和内齿轮 26。 旋钮 16和子针展开长度刻度盘 17 装在操作手柄 18上, 刻度盘 17外的壳体是透明的, 指针 171固定在中间小齿轮 27的轴上, 子针 12展开长短可通过指针 171和刻度盘 17准确地读出, 子针 12 针尖 11的测温热偶 120通过热偶引线 121连接到多芯插头 21上。  As shown in FIG. 1, FIG. 2 and FIG. 11, the operation handle 18 includes: a knob 16, a sub-needle extended length dial 17, a pointer 171, a plurality of gears 27 and an internal gear 26. The knob 16 and the sub-needle extension length dial 17 are mounted on the operating handle 18. The outer shell of the dial 17 is transparent, and the pointer 171 is fixed on the shaft of the intermediate pinion 27. The disc 17 is accurately read out, and the temperature measuring thermocouple 120 of the sub-pin 12 and the tip 11 is connected to the multi-core plug 21 through a thermocouple lead 121.
图 10和图 11示出齿轮基板 7和操作手柄 18的结构图。 装配时, 将齿轮基 板 7装到操作手柄 18的壳体上即可以形成完整的、 内含齿轮的操作手柄 18。  10 and 11 illustrate the configuration of the gear substrate 7 and the operation handle 18. When assembling, the gear base plate 7 is mounted on the housing of the operating handle 18 to form a complete operating handle 18 containing gears.
在临床应用中, 将针尖 11穿刺到肿块最深的边缘, 然后将导向缝 13展开, 转动旋钮 16将子针 12展开约 1厘米, 然后加电, 使各测温点的温度升到 60°C 一 90°C, 依次类推, 直到子针 12全部展开为止。 在治疗过程中消融系统计算机 将名点的温度记录下来再用三维立体彩图表示出肿瘤边缘各部分的治疗温度。如 果子针 12展开一半长度时, 各子针 12尖端之间的距离大于 1厘米, 可在完成上 述治疗后将子针 12完全收回,在保持针尖 11位置不变的状态下将针柄转动一个 小角度, 再进行一次上述的治疗。 设子针 12的数量为 N做 M次上述的治疗, 就 相当于用具有 NXM个子针 12的射频消融切缘电极 1做一个靶点的治疗。 例如, 当子针 12数为 10枚, 做上述 3次治疗, 则相当于用具有 30枚子针 12的射频消 融切缘电极 1进行一下靶点的治疗。  In clinical application, pierce the needle tip 11 to the deepest edge of the mass, and then unfold the guide seam 13. Turn the knob 16 to expand the sub-needle 12 by about 1 cm, and then power on to raise the temperature of each temperature measurement point to 60 ° C. -90 ° C, and so on until the needle 12 is fully extended. During the treatment process, the computer of the ablation system records the temperature of the famous point and then displays the treatment temperature of each part of the tumor edge with a three-dimensional color chart. If the distance between the tip of each sub-needle 12 is greater than 1 cm when the sub-needle 12 is unfolded halfway, the sub-needle 12 can be completely retracted after the above treatment is completed, and the needle handle is rotated by one while maintaining the position of the needle tip 11 unchanged. For a small angle, repeat the above treatment. Setting the number of sub-pins 12 to N for the above-mentioned treatment is equivalent to using RF ablation incision electrode 1 with NXM sub-pins 12 as a target treatment. For example, when the number of sub-needle 12 is 10 and the above three treatments are performed, it is equivalent to perform radiofrequency ablation incision electrode 1 with 30 sub-needle 12 for target treatment.
以下结合附图 12- 24说明按照本发明第二个实施例的射频消融切缘电极 1。 如图 12和图 13所示,按照本发明第二个实施例的射频消融切缘电极 1主要 包括: 针尖 11, 子针 12, 针杆 14, 子针导向缝调节钮 15, 操作手柄 18, 引线 电缆 20和多芯插头 21。  A radio frequency ablation electrode 1 according to a second embodiment of the present invention will be described below with reference to Figs. 12-24. As shown in FIG. 12 and FIG. 13, the radio frequency ablation cutting edge electrode 1 according to the second embodiment of the present invention mainly includes: a needle tip 11, a sub-needle 12, a needle bar 14, a sub-needle guide slit adjustment button 15, an operation handle 18, The lead cable 20 and the multi-core plug 21.
子针 12可以是多枚, 比如至少 6—14枚。 如图 12所示, 子针 12的尖端都 装有测温热偶 120, 而且只有装有测温热偶 120的那段 1一 3厘米的子针 12是导 电的, 子针 12的其他部分和针尖 11、 针杆 14上都涂有绝缘层。 当子针 12全部 展开时, 各子针 12尖端与针杆 14的距离均小于 2厘米, 从而能构成扁球形。如 图 13所示, 多枚子针 12分成左右枚数相等或不相等的两组, 两组子针 12的末 端分别绕在操作手柄 18内左右两个内齿轮 26外缘的窄槽 261内,这样可在操作 手柄 18的纵向长度小于 10厘米的情况下, 也能使子针 12展开的长度大于 7厘 米。 因此, 当所有子针 12完全展开后, 能构成长直径大于 5厘米的扁球形。 The number of sub-pins 12 may be multiple, such as at least 6-14. As shown in FIG. 12, the tip of the sub-needle 12 is equipped with a temperature measuring thermocouple 120, and only the 1-3 cm section of the sub-needle 12 equipped with the temperature measuring thermocouple 120 is conductive, and other parts of the sub-needle 12 And the needle tip 11 and the needle bar 14 are coated with an insulating layer. When the needle 12 When unfolding, the distance between the tip of each sub-needle 12 and the needle bar 14 is less than 2 cm, so as to form an oblate shape. As shown in FIG. 13, the plurality of sub-needles 12 are divided into two groups with equal or unequal numbers of left and right. In this case, when the longitudinal length of the operation handle 18 is less than 10 cm, the length of the sub-needle 12 can be extended to be more than 7 cm. Therefore, when all the sub-pins 12 are fully deployed, they can form oblate spheres with a diameter greater than 5 cm.
如图 12和图 13所示,通过转动左右两个小齿轮 27可分别将两组子针 12从 子针导向缝 13展开与收回。 图 12中所示的多芯插头 21为两只, 但可以根据实 际情况改变其个数。  As shown in Figs. 12 and 13, two sets of sub-needles 12 can be unfolded and retracted from the sub-needle guide slits 13 by rotating the left and right small pinions 27, respectively. There are two multi-core plugs 21 shown in FIG. 12, but the number can be changed according to the actual situation.
图 12中的旋钮 16和子针展开长度刻度盘 17在操作手柄 18上的上下两侧对 应排列。 子针 12的展开 /收回分别受相应的旋钮 16控制, 而展开的长度也由相 应的刻度盘 17和指针 171指示。  The knob 16 and the sub-needle extended length dial 17 in FIG. 12 are arranged correspondingly on the upper and lower sides of the operation handle 18. The expansion / retraction of the sub-needle 12 is controlled by the corresponding knobs 16, and the length of the expansion is also indicated by the corresponding dial 17 and pointer 171.
• 图 13是射频消融切缘电极 1操作手柄 18的剖视图,由此图可详细地了解该 消融切缘电极 1各主要部件的相互连接关系。  • FIG. 13 is a cross-sectional view of the operation handle 18 of the radio frequency ablation incision edge electrode 1. From this figure, the mutual connection relationship of the main components of the ablation incision edge electrode 1 can be understood in detail.
如图, 子针 12穿过针杆外套 141后, 分成左右相等的两组, 绕在左右两只 内齿轮 26的外缘窄槽 261内(参考图 20)其末端固定在内齿轮 26的固定孔 262 上(参考图 20), 并且穿过槽内的固定孔 262到达内齿轮 26的中心轴上。  As shown in the figure, after the needle 12 passes through the needle bar housing 141, it is divided into two groups of equal left and right. Hole 262 (refer to FIG. 20), and pass through the fixing hole 262 in the groove to the central axis of the internal gear 26.
各子针 12测温热偶的引线 121和射频信号线一起通过操作手柄 18的引线柱 183 (参考图 24)构成引线电缆 20, 引线电缆 20与多芯插头 21相连。这种结构 能使操作手柄 18的纵向长度大大缩短, 当釆用 CT对肿块进行定位时,操作手柄 18的缩短是十分重要的, 尤其是对那些较肥胖的患者更为必要。  The lead wires 121 of the temperature measuring thermocouples of each of the sub-pins 12 and the RF signal wires pass through the lead posts 183 of the operating handle 18 (refer to FIG. 24) to form a lead cable 20, and the lead cable 20 is connected to the multi-core plug 21. This structure can greatly shorten the longitudinal length of the operating handle 18. When CT is used to locate the mass, the shortening of the operating handle 18 is very important, especially for those who are more obese.
由图 13可见, 旋钮 16可安装在小齿轮 27轴的一端上, 而子针展开长度刻 度盘 17上的指针 171也是安装在内齿轮 26的中心轴的另一端上。  As can be seen from FIG. 13, the knob 16 can be mounted on one end of the pinion 27 shaft, and the pointer 171 on the sub-needle extended length scale 17 is also mounted on the other end of the central shaft of the internal gear 26.
如图 15所示,针尖 11一般釆用不锈钢制成,针尖头 111一般做成圆锥形或 三棱针形。 该针尖 11的作用是经皮刺入肿瘤组织, 需要说明的是, 圆锥形针尖 头 111对病人造成的损伤更小, 做肺肿瘤治疗时不易产生气胸。 针尖 11上可设 有 3— 4个小孔 112, 它与图 15所示的针尖连杆 22和注药嘴 19相通。 在治疗中 可通过注药嘴 19, 针尖连杆 22和针尖上的小孔 112向肿瘤组织内注入生理盐水 或其他药液。  As shown in FIG. 15, the needle tip 11 is generally made of stainless steel, and the needle tip 111 is generally formed into a conical or triangular needle shape. The function of the needle tip 11 is to penetrate into the tumor tissue percutaneously. It should be noted that the conical needle tip 111 causes less damage to the patient, and it is not easy to generate pneumothorax when treating lung tumors. The needle tip 11 may be provided with 3-4 small holes 112, which communicate with the needle tip link 22 and the injection nozzle 19 shown in FIG. During the treatment, a normal saline or other medicinal solution can be injected into the tumor tissue through the injection nozzle 19, the needle link 22 and the small hole 112 on the needle tip.
子针 12—般由弹性好的不锈钢管制成。 图 16示出了子针 12的详细结构, 不锈钢管内有测温热偶引线 121,测温热偶 120位于子针 12的尖端。可以将 6— 14 枚子针 12分成相等的两组焊在一起。子针 12焊接后的横截面也为中空圆形, 圆 形的外径应略小于针杆外套 141的内径。热偶引线 121经过引线柱 183引出并与 多芯插头 21相连。  The needle 12 is generally made of a flexible stainless steel tube. FIG. 16 shows the detailed structure of the sub-needle 12. The stainless steel tube has a temperature measuring thermocouple lead 121, and the temperature measuring thermocouple 120 is located at the tip of the sub-needle 12. 6-14 sub-pins 12 can be divided into two equal groups and welded together. The cross section of the sub-pin 12 after welding is also a hollow circle, and the outer diameter of the circle should be slightly smaller than the inner diameter of the needle bar jacket 141. The thermocouple lead 121 is led out through a lead post 183 and is connected to the multi-core plug 21.
子针 12展开后的形状是依装配书制成的, 为增加其弹性, 采用了类似的加 工一般弹簧的制作工艺。子针 12展开所形成的扁球形的长直径与子针 12本身的 铒细有关, 它越粗, 扁球形的长直径就越大。 The expanded shape of the sub-pin 12 is made according to the assembly book. To increase its elasticity, a similar Manufacturing process of general spring. The long diameter of the oblate sphere formed by the development of the sub-needle 12 is related to the thinness of the sub-needle 12 itself. The thicker it is, the larger the long diameter of the oblate sphere.
子针导向缝 13的大小于扁球形的长直径有关, 子针导向缝 13越小, 扁球形 的长直径也越小。  The size of the sub-needle guide seam 13 is related to the oblate long diameter. The smaller the sub-needle guide seam 13 is, the smaller the oblong long diameter is.
当然, 要增大扁球形长直径的尺寸, 就必须加长子针 12展开的长度; 如果 采用传统的推柱方式操作手柄, 操作手柄的纵向长度就会太长。本发明是将子针 12分为 2组, 分别绕在操作手柄 18内的两只内齿轮 26的外线上, 从而大大缩 短了操作手柄的纵向长度。  Of course, to increase the size of the oblate long diameter, it is necessary to lengthen the extended length of the pin 12; if the handle is operated by the traditional push column method, the longitudinal length of the operation handle will be too long. In the present invention, the sub-needle 12 is divided into two groups, which are respectively wound on the outer wires of the two internal gears 26 in the operation handle 18, thereby greatly shortening the longitudinal length of the operation handle.
如图 14所示的针杆外套 141一般是用不锈钢管制成,其直径为 1. 2-2. 0mm, 外涂有绝缘层并标有刻度尺, 以表明刺入组织内的深度。 针杆外套 141 的远端 142与针尖 11的末端 113构成子针导向缝 13,导向缝 13的宽度由安装在操作手 柄 18上的子针导向缝旋钮 15调节, 子针 12展开后的直径主要取决于导向缝的 宽度。 由图 19可见, 针杆外套 141的近端 146与齿轮基板 25上的针杆外套固定 孔 253焊接在一起。 如图 15可见, 针尖 11与注药管 22, "Z"形架 23, 空芯螺 钉 24和注药嘴 19应相互牢固连接。 "Z"形架 23的作用是防止用导向缝调节钮 15调节导向缝 13大小时针尖 11旋转。 "Z"形架 23的两个端点由操作手柄外壳 181的内腔宽度限位。  The needle bar jacket 141 shown in FIG. 14 is generally made of a stainless steel tube with a diameter of 1.2 to 2.0 mm, and is coated with an insulation layer and marked with a scale to indicate the depth of penetration into the tissue. The distal end 142 of the needle bar jacket 141 and the distal end 113 of the needle tip 11 form a sub-needle guide seam 13, the width of the guide seam 13 is adjusted by the sub-needle guide seam knob 15 installed on the operation handle 18, and the diameter of the sub-needle 12 after the expansion is mainly Depends on the width of the guide seam. It can be seen from FIG. 19 that the proximal end 146 of the needle bar housing 141 and the needle bar housing fixing hole 253 on the gear base plate 25 are welded together. As can be seen in Figure 15, the needle tip 11 and the injection tube 22, the "Z" -shaped frame 23, the hollow screw 24 and the injection nozzle 19 should be firmly connected to each other. The role of the "Z" -shaped frame 23 is to prevent the needle tip 11 from rotating when the size of the guide slit 13 is adjusted by the guide slit adjusting button 15. The two ends of the “Z” -shaped frame 23 are limited by the inner cavity width of the operating handle housing 181.
如图 18所示,子针导向缝调节钮 15是由一通用螺母 151和一个中空圆柱形 旋钮 16组合而成, 它们之间应牢固接合, 旋钮的颈部 152镶嵌在上下操作手柄 外壳 151的半圆孔 154内, 如图 24所示。  As shown in FIG. 18, the sub-needle guide seam adjusting button 15 is a combination of a universal nut 151 and a hollow cylindrical knob 16, which should be firmly connected with each other. The neck 152 of the knob is embedded in the upper and lower operation handle housing 151. Inside the semi-circular hole 154, as shown in FIG.
图 17为图 18与图 15的结合。 由图 17可见, 当旋转子针导向缝旋钮 15时, 由于 "V,形架 23和子针导向缝旋钮 15受到上下操作手柄外壳 181的限位, 使 图 15所示的组合件只能上下位移,而针杆外套 141是固定在齿轮基板 25上的针 杆外套固定孔 253上, 这样子针导向缝 13就能改变其大小, 子针导向缝 13是决 定子针 12展开后直径尺寸的关键部位, 调节子针导向缝 13的大小, 可制做出子 针 12展开后长直径大到 5-12厘米,且各子针 12的尖端接近针杆 14的扁球形射 频消融切缘电极 1。  FIG. 17 is a combination of FIG. 18 and FIG. 15. It can be seen from FIG. 17 that when the sub-needle guide slit knob 15 is rotated, because “V, the shaped frame 23 and the sub-needle guide slit knob 15 are limited by the upper and lower operation handle housing 181, the assembly shown in FIG. 15 can only be displaced up and down The needle bar cover 141 is fixed to the needle bar cover fixing hole 253 on the gear substrate 25. In this way, the sub-needle guide seam 13 can change its size. The sub-needle guide seam 13 is the key to determine the diameter of the sub-needle 12 after it is unfolded. The size of the guide needle guide slit 13 can be adjusted to make the long diameter of the sub needle 12 expanded to 5-12 cm, and the tip of each sub needle 12 is close to the oblate radio frequency ablation electrode 1 of the needle shaft 14.
图 19为齿轮基板 25的结构图。 每支射频消融切缘电极 1的操作手柄 18内 有上下两只齿轮基板 25, 其上有两个小齿轮轴孔 251和两个内齿轮轴孔 252, 各 齿轮基板 25的左右两端应与操作手柄外壳 181相连。  FIG. 19 is a configuration diagram of the gear substrate 25. There are two upper and lower gear base plates 25 in the operating handle 18 of each radio frequency ablation incision edge electrode 1, and there are two pinion shaft holes 251 and two internal gear shaft holes 252. The operation handle housing 181 is connected.
图 20和图 21为内齿轮 26和小齿轮 27的结构图。 内齿轮 26的外缘中间有 一窄槽 261,子针 12的末端绕在此槽内,窄槽 261的宽度应为子针 12直径的 N/2 倍, 其中 N为子针 12的枚数。  20 and 21 are structural diagrams of the internal gear 26 and the pinion 27. There is a narrow slot 261 in the middle of the outer edge of the internal gear 26. The end of the sub-pin 12 is wound in this slot. The width of the narrow slot 261 should be N / 2 times the diameter of the sub-pin 12, where N is the number of the sub-pin 12.
图 22为梯形链条 28的结构图。该梯形链条 28包括防胀条 281和柔性线 282。 防胀条 281最好用金属制成,柔性线 282用高强度柔性好的尼龙线制成, 防胀条 281和柔性线 282要牢固接合, 梯形链条 28的 A端与一组子针 12的近端一起固 定在内齿轮 26的子针固定孔 262处, 梯形链条 28就能紧紧绕在内齿轮 26的外 缘上, 内齿轮 26与图 23所示的梯形链条外导轨 29应固定在一起。 由图 2可见, 当子针 12全部展开时,梯形链条 28的所有防胀条 281都会聚集在操作手柄外壳 181的引线柱 183附近, 而当子针 12完全收回时, 梯形链条 28的防胀条 281又 会均匀地分布在内齿轮 26的外缘上。 FIG. 22 is a structural diagram of a trapezoidal chain 28. The trapezoidal chain 28 includes an anti-swelling strip 281 and a flexible wire 282. The anti-expansion bar 281 is preferably made of metal, and the flexible wire 282 is made of high-strength and flexible nylon thread. The anti-expansion bar 281 and the flexible wire 282 should be firmly connected. The A end of the trapezoidal chain 28 and a group of sub-pins 12 The proximal ends are fixed together at the sub-pin fixing holes 262 of the internal gear 26, and the trapezoidal chain 28 can be tightly wound on the outer edge of the internal gear 26. The internal gear 26 and the external guide rail 29 of the trapezoidal chain shown in FIG. together. It can be seen from FIG. 2 that when the sub needle 12 is fully deployed, all the anti-swelling strips 281 of the trapezoidal chain 28 will gather near the lead post 183 of the operation handle housing 181, and when the sub needle 12 is fully retracted, the anti-swelling of the trapezoidal chain 28 The strips 281 are evenly distributed on the outer edge of the ring gear 26.
图 23为梯形链条外导轨 26的结构图。 它与内齿轮 26固定在一起, 以使内 齿轮 26有牢固的中心轴孔 291, 它最主要的用途是在子针 12展开过程中压紧梯 形链条 28, 以防止子针 12从窄槽 261中弹出。  FIG. 23 is a structural diagram of the outer guide rail 26 of the trapezoidal chain. It is fixed with the internal gear 26 so that the internal gear 26 has a solid central shaft hole 291. Its main purpose is to press the trapezoidal chain 28 during the development of the sub-needle 12 to prevent the sub-needle 12 from passing through the narrow groove 261. Pop out.
图 24为操作手柄外壳 18的结构图。 它与齿轮基板 25, 内齿轮 26, 小齿轮 27, 梯形链条 28, 梯形链条外导轨 29, 旋钮 16和子针展开长度刻度盘 17—起 构成了射频消融切缘电极 1的操作手柄 18 (见图 12和图 13)。  FIG. 24 is a structural diagram of the operation handle housing 18. It is combined with the gear base plate 25, the internal gear 26, the pinion 27, the trapezoidal chain 28, the trapezoidal chain outer guide 29, the knob 16 and the sub-needle extended length dial 17 to form the operation handle 18 of the RF ablation edge electrode 1 (see figure 12 and Figure 13).
图 12为第二个实施例的射频消融切缘电极子针展开后的外形图; 为看清子 针展开长度刻度盘 17的读数, 与子针展开长度刻度盘对应的操作手柄壳体是用 透明材料制成的, 如有机玻璃板。 指针 171固定在内齿轮 26的中心轴上, 子针 12展开的长短可通过指针 171和刻度盘 17准确读出。子针尖端 122的测温热偶 120通过热偶引线 121连接到多芯插头 21上。  FIG. 12 is an external view of a radio frequency ablation cut-edge electrode sub-needle of the second embodiment after being unfolded; in order to see the reading of the sub-needle expanded length dial 17, the operation handle housing corresponding to the sub-needle expanded length dial is transparent Made of materials such as plexiglass plates. The hand 171 is fixed on the central axis of the internal gear 26, and the length of the sub-hand 12 can be read out accurately through the hand 171 and the dial 17. The thermocouple 120 of the needle tip 122 is connected to the multi-core plug 21 through a thermocouple lead 121.
在临床应用上, 将针尖 11穿刺到肿块最深的边缘, 转动旋钮 16, 先将子针 12展开约 1厘米, 然后加电, 使各测温点的温度升高到 60°C-9(TC ; 将子针 12 再增长 1厘米后, 再加电, 使各测温点的温度升高到 60Ό- 9(TC, 依次类推, 直 到子针 12全部展开为止。在治疗过程中消融系统计算机将各点的温度记录下来, 再用三维立体彩图表示出肿瘤边缘各点的治疗温度。 In clinical application, puncture the needle tip 11 to the deepest edge of the mass, turn the knob 16, first expand the sub-needle 12 by about 1 cm, and then power on to raise the temperature of each temperature measurement point to 60 ° C-9 (TC After the sub-needle 12 is further increased by 1 cm, power is applied to increase the temperature of each temperature measurement point to 60 ° -9 (TC, and so on, and so on, until the sub-needle 12 is fully expanded. During the treatment process, the computer of the ablation system will The temperature of each point was recorded, and the three-dimensional color chart was used to show the treatment temperature of each point of the tumor edge.
如果子针 12展开一半长度时, 各子针尖端 122之间的距离大于 1厘米, 可 在完成上述治疗后将子针 12完全收回,在保持针尖 11位置不变的状态下将子针 操作手柄 18转动一个小角度, 再进行上述的治疗。 设子针 12的数量为 N, 做 M 次上述治疗,就相当于用具有 NXM个子针 12的射频消融切缘电极 1做一次治疗。 例如, 当子针 12数为 10枚, 做上述 3次治疗, 则相当于用具有 30枚子针 12的 射频消融切缘电极 1进行一次治疗。  If the distance between the sub-needle tips 122 is greater than 1 cm when the sub-needle 12 is unfolded by half the length, the sub-needle 12 can be completely retracted after completing the above treatment, and the sub-needle operation handle can be maintained while keeping the position of the needle tip 11 unchanged. 18 Rotate a small angle, and then perform the above treatment. Assuming that the number of sub-needles 12 is N, performing the above-mentioned treatments M times is equivalent to using radio frequency ablation incision electrode 1 having NXM sub-needles 12 for one treatment. For example, when the number of sub-pins is 10 and the above three treatments are performed, it is equivalent to performing one treatment with the radiofrequency ablation incision electrode 1 having 30 sub-pins 12.
虽然以上详细描述了本发明的两个最佳实施例, 但本领域技术人员应理解: 在不脱离由所附权利要求限定的本发明范围和思想的情况下, 可进行各种改进、 添加和替代。例如:第二实施例中的一个或多个部件可以替换第一实施例的对应 部件,或者,第一实施例的部件与第二实施例的部件组合可以构成新的射频消融 切缘电极。  Although the two preferred embodiments of the present invention have been described in detail above, those skilled in the art should understand that various modifications, additions and improvements can be made without departing from the scope and spirit of the present invention as defined by the appended claims. Instead. For example, one or more components in the second embodiment may replace the corresponding components of the first embodiment, or a combination of the components of the first embodiment and the components of the second embodiment may constitute a new radiofrequency ablation edge electrode.

Claims

权利要求书 Claim
1.一种射频消融电极, 包括针尖 (11 )、 子针 (12 )、 针杆 (14)、 操作手柄 ( 18)、 引线电缆 (20) 和多芯插头 (21 ) ,其特征在于, 当所有子针 (12)完全 展开后构成长直径不小于 5厘米的扁球形。 A radio frequency ablation electrode comprising a needle tip (11), a sub-needle (12), a needle bar (14), an operation handle (18), a lead cable (20), and a multi-core plug (21), characterized in that: After all the sub-pins (12) are fully unfolded, they form oblate spheres with a diameter of not less than 5 cm.
2.根据权利要求 1所述的射频消融电极, 其特征在于, 多枚子针(12)分为 相等或不相等的两组, 两组子针 (12) 的末端绕在操作手柄 (18) 内左右两只内 齿轮 (26) 外缘的窄槽 (216) 内。 The radio frequency ablation electrode according to claim 1, characterized in that the plurality of sub-needles (12) are divided into two groups of equal or unequal, and the ends of the two sub-needles (12) are wound around the operation handle (18) Inside the narrow grooves (216) on the outer edges of the two inner gears (26).
3.根据权利要求 2所述的射频消融电极, 其特征在于, 内齿轮(26) 内还设 有小齿轮 (27), 小齿轮 (27) 的轴上装有旋钮 (16)。 The radio frequency ablation electrode according to claim 2, characterized in that the internal gear (26) is further provided with a pinion (27), and a knob (16) is mounted on a shaft of the pinion (27).
4.根据权利要求 2所述的射频消融电极, 其特征在于, 内齿轮(26) 的外缘 设有防胀环 (9) 或梯形链条 (28)。 The radio frequency ablation electrode according to claim 2, characterized in that the outer edge of the internal gear (26) is provided with an anti-swelling ring (9) or a trapezoidal chain (28).
5.根据权利要求 1所述的射频消融电极,其特征在于,针尖(11 )和针杆(14) 之间形成子针导向缝 (13 ), 两组子针 (12 ) 从子针导向缝 (13) 分别或同时展 开或收回。 The radio frequency ablation electrode according to claim 1, characterized in that a sub-needle guide seam (13) is formed between the needle tip (11) and the needle shaft (14), and two sets of sub-needles (12) are guided from the sub-needle guide seam (13) Expand or retract separately or simultaneously.
6.根据权利要求 5所述的射频消融电极, 其特征在于, 在操作手柄(18)上 装有一子针导向缝调节钮 (15), 它调节子针导向缝 (13) 的宽度的。 The radio frequency ablation electrode according to claim 5, characterized in that a sub-needle guide slit adjusting button (15) is installed on the operation handle (18), which adjusts the width of the sub-needle guide slit (13).
7.根据权利要求 1所述的射频消融电极, 其特征在于, 所有子针(12) 的尖 端都装有测温热偶 (120)。 The radio frequency ablation electrode according to claim 1, characterized in that the tip ends of all the sub-needles (12) are equipped with temperature measuring thermocouples (120).
8.根据权利要求 7所述的射频消融电极, 其特征在于, 所有子针(12) 的尖 端有 1-3厘米是导电的, 子针的其他部分和针尖 (11 )、 针杆 (14) 上都有绝缘 层。 The radio frequency ablation electrode according to claim 7, characterized in that 1-3 cm of the tips of all the sub-needles (12) are conductive, and other parts of the sub-needle, the needle tip (11), and the needle shaft (14) There are insulation layers on it.
9.根据权利要求 1所述的射频消融电极, 其特征在于, 操作手柄(18)上装 有如钟表形的子针展开长度刻度盘 (17) 和指针 (171 )。 The radio frequency ablation electrode according to claim 1, characterized in that the operation handle (18) is equipped with a clock-shaped sub-needle deployment length dial (17) and a pointer (171).
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