技术领域technical field
本发明涉及射频技术领域，并且更具体地，涉及一种低温等离子剥离刀手术设备。The present invention relates to the technical field of radio frequency, and more particularly, relates to a low-temperature plasma stripping knife operation equipment.
背景技术Background technique
随着消化内镜技术的不断发展，消化道疾病的内镜下治疗也越来越普及。内镜下黏膜下剥离术用于治疗消化道早期癌，使得更多的消化道病变能够一次性地在内镜下大块完整切除。可免除传统手术治疗风险，具有创伤小、疗效好、手术技术要求高等特点。With the continuous development of digestive endoscopy technology, endoscopic treatment of gastrointestinal diseases is becoming more and more popular. Endoscopic submucosal dissection is used to treat early-stage gastrointestinal cancer, so that more gastrointestinal lesions can be completely resected under endoscopy at one time. It can avoid the risk of traditional surgical treatment, and has the characteristics of small trauma, good curative effect, and high surgical technical requirements.
高频剥离电刀是一种取代机械手术刀进行组织剥离的电外科器械。高频剥离电刀的工作原理是通过有效电极尖端产生的高频高压电流与机体接触时对组织进行加热，实现对机体组织的分离和凝固，从而起到剥离和止血的目的。高频剥离电刀电凝模式的峰值电压较电切模式大，高频电流通过高阻抗的组织时，会在组织中热量，导致组织气化或凝固，产生良好的止血效果，但同时也会造成更加明显的热损伤。高频剥离电刀瞬间稳定可高达150℃以上，能剥离组织的高频剥离电刀的加热效应，并不是由加热电极或刀头造成的。它是将高电流密度的高频电流聚集起来，直接摧毁处于与有效电极尖端相接触的组织。当与有效电极相接触或相邻近的组织或细胞的温度上升到细胞中的蛋白质变性时，便产生剥离及凝固的作用。High-frequency electrosurgical dissection is an electrosurgical instrument that replaces mechanical scalpels for tissue dissection. The working principle of the high-frequency stripping electrotome is to heat the tissue when the high-frequency high-voltage current generated by the effective electrode tip contacts the body, so as to separate and coagulate the body tissue, thereby achieving the purpose of stripping and hemostasis. The peak voltage of high-frequency stripping electrotome electrocoagulation mode is larger than that of electric cutting mode. When high-frequency current passes through high-impedance tissue, it will generate heat in the tissue, resulting in tissue gasification or coagulation, resulting in a good hemostatic effect, but at the same time Cause more obvious thermal damage. The high-frequency stripping electrotome can be stable up to 150°C in an instant, and the heating effect of the high-frequency stripping electrotome that can strip tissues is not caused by heating electrodes or cutter heads. It gathers high-frequency current with high current density to directly destroy the tissue in contact with the effective electrode tip. When the temperature of the tissue or cell in contact with the effective electrode or adjacent to it rises to denature the protein in the cell, peeling and coagulation will occur.
普通高频剥离电刀的工作温度通常是100～150℃，这个工作温度相对人组织仍属于高温，组织细胞受此温度影响后，由于剥离所造成组织蛋白变性。尤其是普通高频剥离电刀持续工作一定时间后，会对组织造成热损伤。而组织细胞的变性坏死是一个逐渐发展的过程，普通高频剥离电刀会出现术区肿胀、术后疼痛等反应。The working temperature of ordinary high-frequency peeling electrotome is usually 100-150°C, which is still a high temperature compared to human tissues. After the tissue cells are affected by this temperature, the tissue proteins will be denatured due to the peeling. Especially after a certain period of continuous operation of the ordinary high-frequency stripping electrotome, it will cause thermal damage to the tissue. The degeneration and necrosis of tissue cells is a gradual process, and ordinary high-frequency stripping electrotome will cause swelling in the operation area, postoperative pain and other reactions.
在实际环境中，高频剥离电刀应用在医院进行肠胃里面的诸如早癌的病变部位的剥离术中容易产生并发症，这是因为温度对组织有损伤。高频剥离电刀有两个电极，一个电极贴在患者身上，另一个电极放置在剥离刀部位，并且在手柄上设置电通路。高频发射温度高达400-500度，这个温度对周边良好的组织会误伤，进而使得出血问题产生的概率高、容易损坏病理组织。在这种情况下，医生无法进行病理分析，并且对切片整理有效分析时造成麻烦。In the actual environment, high-frequency electrosurgical dissection is prone to complications in the dissection of gastrointestinal lesions such as early cancer in the hospital, because the temperature can damage the tissue. The high-frequency electrosurgical scalpel has two electrodes, one electrode is attached to the patient, the other electrode is placed on the scalpel, and an electrical path is set on the handle. The high-frequency emission temperature is as high as 400-500 degrees. This temperature will accidentally injure the surrounding good tissues, which in turn makes the probability of bleeding problems high and easily damages pathological tissues. In this case, the doctor cannot perform the pathological analysis, and it causes trouble in effectively analyzing the slices.
申请号为CN201520088201.1的实用新型公开了一种可弯曲黏膜剥离刀，它包括：手柄；导管，导管内设置有弯曲牵引腔和电切刀腔，导管的头部具有牵拉可弯曲部分，并且在导管的牵拉可弯曲部分的尾端侧壁上设置有与弯曲牵引腔相连通的牵引孔；分腔管，分腔管的一端与导管连接，另一端与手柄连接，并且分腔管的分腔与弯曲牵引腔相连通，分腔管的主腔与电切刀腔相连通；牵引手柄，牵引手柄可移动地连接在分腔管的分腔出口上；牵引弯曲丝，牵引弯曲丝的头端与导管的头端相连接，牵引弯曲丝从导管外侧通过牵引孔穿进导管的推杆腔和分腔管的推杆腔内后，再与牵引手柄连接。它能够在剥离手术中，能较顺利的找到病变部位，从而进行手术操作，不用频繁的调整内镜，对盲区也能很好的进行手术操作。The utility model with the application number CN201520088201.1 discloses a flexible mucosal dissection knife, which includes: a handle; a catheter, a curved traction cavity and an electric knife cavity are arranged in the catheter, and the head of the catheter has a pulling and bending part. And on the side wall of the tail end of the traction flexible part of the catheter, a traction hole communicating with the curved traction cavity is provided; a sub-lumen tube, one end of the sub-lumen tube is connected with the catheter, and the other end is connected with the handle, and the sub-lumen tube The sub-chamber of the sub-cavity is connected with the curved traction cavity, and the main cavity of the sub-cavity tube is connected with the electric knife cavity; the traction handle is movably connected to the sub-chamber outlet of the sub-cavity tube; the traction bending wire, the traction bending wire The head end of the catheter is connected with the head end of the catheter, and the traction bending wire penetrates the push rod chamber of the catheter and the push rod chamber of the sub-lumen tube from the outside of the catheter through the traction hole, and then is connected with the traction handle. It can find the diseased part more smoothly in the stripping operation, so as to perform the operation, without frequent adjustment of the endoscope, and can also perform the operation on the blind area very well.
申请号为CN 201520088253.9的实用新型公开了一种带推杆的黏膜剥离刀，它包括：手柄；导管，导管内设置有推杆腔和电切刀腔；分腔管，分腔管的一端与导管连接，另一端与手柄连接，并且分腔管的分腔与推杆腔相连通，分腔管的主腔与电切刀腔相连通；推杆手柄，推杆手柄活动连接在分腔管的分腔出口上；推杆组件，推杆组件依次穿过导管的推杆腔和分腔管的推杆腔后，再与推杆手柄连接，推杆组件的头端设置有推杆；滑环，滑环设置在手柄上，滑环上设置有电极；电切刀组件，电切刀组件依次穿过导管的电切刀腔和分腔管的主腔后，再与滑环上的电极电性连接，电切刀组件的头端设置有电切刀。本实用新型在内镜剥离手术中能够获得比较好的视野，从而避免因为镜头无法观察到电切刀剥离组织的情况，减少了手术的风险。The utility model with the application number CN 201520088253.9 discloses a mucosal dissection knife with a push rod, which includes: a handle; a catheter with a push rod cavity and an electric knife cavity inside the catheter; a lumen-dividing tube, one end of which is connected to The catheter is connected, the other end is connected with the handle, and the sub-cavity of the sub-lumen tube is connected with the push rod cavity, and the main cavity of the sub-lumen tube is connected with the electric knife cavity; the push rod handle is movably connected to the sub-lumen tube on the sub-cavity outlet; the push rod assembly, the push rod assembly passes through the push rod cavity of the catheter and the push rod cavity of the sub-lumen tube in turn, and then is connected with the push rod handle, and the head end of the push rod assembly is provided with a push rod; ring, the slip ring is set on the handle, and the electrode is set on the slip ring; the electric knife assembly, the electric knife assembly passes through the electric knife cavity of the catheter and the main cavity of the sub-lumen tube in turn, and then connects with the electrode on the slip ring Electrically connected, the head end of the electric cutter assembly is provided with an electric cutter. The utility model can obtain relatively good field of vision in the endoscopic stripping operation, thereby avoiding the situation that the tissue stripped by the electric cutter cannot be observed by the lens, and reduces the risk of the operation.
申请号为CN201420542621.8的实用新型公开了一种弯柄显微外科手术剥离刀，包括刀柄和刀头，所述刀柄的下端通过刀座与所述刀头的上端连接；所述刀头的上端与所述刀座的下端固定连接，所述刀座的上端与所述刀柄的下端卡合连接；所述上卡合部和所述下卡合部所在直线与所述刀头所在直线相交形成第一夹角；所述刀柄分为柄头段和柄尾段，所述柄头段呈板形条，所述柄尾段呈长柱体，所述柄头段与所述柄尾段之间为平滑过度连接并形成第二夹角。本实用新型的弯柄显微外科手术剥离刀不但拆装方便，而且，容易清洗干净，还可以改变刀头的角度。The utility model with the application number CN201420542621.8 discloses a curved handle microsurgical stripping knife, including a handle and a knife head, the lower end of the knife handle is connected to the upper end of the knife head through a knife seat; the knife The upper end of the head is fixedly connected with the lower end of the knife seat, and the upper end of the knife seat is engaged with the lower end of the handle; Where the straight lines intersect to form a first included angle; the handle is divided into a handle head section and a handle tail section, the handle head section is a plate-shaped strip, the handle tail section is a long cylinder, and the handle head section and the handle end section are in the form of a long cylinder. The ends of the handles are connected smoothly and form a second angle. The curved handle microsurgical stripping knife of the utility model is not only convenient for disassembly and assembly, but also easy to clean, and can also change the angle of the knife head.
然而，上述剥离刀均无法避免温度过高造成的误伤问题，并且刀头和导管在进入人体的过程中无法根据腔道的形状顺势形变，为手术操作带来极大的不便。However, none of the above-mentioned stripping knives can avoid accidental injury caused by excessive temperature, and the knife head and catheter cannot be deformed according to the shape of the cavity when entering the human body, which brings great inconvenience to the operation.
发明内容Contents of the invention
根据本发明的一个方面，提供一种低温等离子剥离刀手术设备，所述设备包括：According to one aspect of the present invention, a kind of low-temperature plasma exfoliation knife operation equipment is provided, and described equipment comprises:
液体输入单元，响应于液体输入信号，向目标体处输入液体从而在发射电极和回路电极之间形成导电介质的薄层；a liquid input unit, in response to a liquid input signal, injecting liquid into the target body to form a thin layer of conductive medium between the transmitting electrode and the return electrode;
双极电极插口接头，通过高频连接线与高频发生器连接，用于接收所述高频发生器所产生的第一输入电压；The bipolar electrode socket connector is connected to the high-frequency generator through a high-frequency connecting line, and is used to receive the first input voltage generated by the high-frequency generator;
发射电极，经由双极电极插口接头接收所述高频发生器所产生的第一输入电压，在发射电极和回路电极之间施加第一电压，使得所述导电介质达到第一温度并且促使所述导电介质被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化剥离，The transmitting electrode receives the first input voltage generated by the high-frequency generator via the bipolar electrode socket connection, and applies the first voltage between the transmitting electrode and the return electrode, so that the conductive medium reaches a first temperature and promotes the The conductive medium is converted into a plasma layer, so that electric energy is used to excite the conductive medium to generate plasma, and the target body is vaporized and stripped based on the radio frequency energy of the plasma,
回路电极，与所述发射电极通过相同的导管导入并且在所述目标体形成导电回路。A return electrode is introduced through the same catheter as the transmitting electrode and forms a conductive loop at the target.
所述双极电极插口接头接收所述高频发生器所产生的第二输入电压并且将所述第二输入电压传输给发射电极，在发射电极和回路电极之间施加第二电压，以使得目标体保持为第二温度，从而促使目标体进行消融凝固。The bipolar electrode socket connector receives the second input voltage generated by the high-frequency generator and transmits the second input voltage to the transmitting electrode, and applies the second voltage between the transmitting electrode and the return electrode, so that the target The volume is maintained at the second temperature, thereby promoting ablation and coagulation of the target volume.
所述低温等离子剥离刀手术设备的发射电极通过发射电极导线连接于双电极插口接头，发射电极导线(剥离刀头导线)包覆绝缘层，绝缘层用于起绝缘和隔热的作用。The emitter electrode of the low-temperature plasma stripping knife operation equipment is connected to the double-electrode socket joint through the emitter electrode wire, and the emitter electrode wire (stripping head wire) is covered with an insulating layer, and the insulating layer is used for insulation and heat insulation.
所述低温等离子剥离刀手术设备还包括通液腔，基于液体输入指令向液体输入单元输入所述液体，其中所述液体输入单元实时测量所述液体的当前余量并且将所述当前余量发送给控制单元，所述控制单元基于所述当前余量确定是否生成所述液体输入指令并且在确定生成所述液体输入指令后将所述液体输入指令发送给液体输入单元。The low-temperature plasma exfoliation knife surgical equipment also includes a liquid cavity, and the liquid is input to the liquid input unit based on the liquid input command, wherein the liquid input unit measures the current remaining amount of the liquid in real time and sends the current remaining amount to to the control unit, the control unit determines whether to generate the liquid input command based on the current remaining amount and sends the liquid input command to the liquid input unit after determining that the liquid input command is generated.
所述液体输入单元通过以下模式中的一种进行液体输入：滴定模式和连续供液模式，并且所述通液腔是位于回路电极之外的环形腔。The liquid input unit performs liquid input through one of the following modes: titration mode and continuous liquid supply mode, and the liquid passage chamber is an annular chamber located outside the return electrode.
为所述发射电极的远离所述低温等离子剥离刀手术设备的发射电极的剥离刀头呈钩状、半圆球状、梅花状、圆柱状或球状。The stripping cutter head, which is the emitter electrode and is far away from the emitter electrode of the low-temperature plasma peeling knife surgical equipment, is in the shape of a hook, a hemisphere, a quincunx, a cylinder or a ball.
所述液体输入单元的输液口位于所述发射电极和回路电极之间。The infusion port of the liquid input unit is located between the transmitting electrode and the returning electrode.
所述低温等离子剥离刀手术设备还包括拉杆，用于使操作者通过把拉杆来提供支撑力，并且所述低温等离子剥离刀手术设备还包括外管，用于提供外层包覆功能。The low-temperature plasma peeling knife surgical device further includes a pull rod, which is used for the operator to provide support force by pulling the pull rod, and the low-temperature plasma peeling knife surgical device also includes an outer tube, which is used for providing an outer coating function.
所述的低温等离子剥离刀手术设备的发射电极通过滑块可伸缩地设置。The emitter electrode of the low-temperature plasma exfoliation knife operation equipment is telescopically arranged through a slider.
所述第一电压的范围为100Vrms至300Vrms，并且所述第二电压的范围为60Vrms至80Vrms。The first voltage ranges from 100Vrms to 300Vrms, and the second voltage ranges from 60Vrms to 80Vrms.
优选地，所述第一电压的范围为100Vrms至300Vrms，并且所述第二电压的范围为60Vrms至80Vrms。Preferably, the first voltage ranges from 100Vrms to 300Vrms, and the second voltage ranges from 60Vrms to 80Vrms.
附图说明Description of drawings
通过参考下面的附图，可以更为完整地理解本发明的示例性实施方式：A more complete understanding of the exemplary embodiments of the present invention can be had by referring to the following drawings:
图1为根据本发明优选实施方式的等离子治疗仪的主要零件示意图；Fig. 1 is a schematic diagram of main parts of a plasma therapy apparatus according to a preferred embodiment of the present invention;
图2为根据本发明优选实施方式的等离子治疗仪的结构示意图；Fig. 2 is a schematic structural view of a plasma therapeutic apparatus according to a preferred embodiment of the present invention;
图3为根据本发明优选实施方式的低温等离子剥离刀手术系统的结构示意图；FIG. 3 is a schematic structural view of a low-temperature plasma exfoliation knife surgery system according to a preferred embodiment of the present invention;
图4为根据本发明优选实施方式的低温等离子剥离刀手术方法的流程图；Fig. 4 is the flowchart of the low temperature plasma exfoliation knife operation method according to the preferred embodiment of the present invention;
图5为根据本发明优选实施方式的低温等离子剥离刀手术设备的结构示意图；以及Fig. 5 is a schematic structural view of a low-temperature plasma exfoliation knife surgical device according to a preferred embodiment of the present invention; and
图6-8为根据本发明优选实施方式的低温等离子剥离刀手术设备的局部放大或截面示意图；6-8 are partially enlarged or cross-sectional schematic diagrams of low-temperature plasma exfoliation knife surgical equipment according to a preferred embodiment of the present invention;
图9为根据本发明的密封组件的剥离刀的侧视图；Figure 9 is a side view of a stripping knife of a seal assembly according to the present invention;
图10为图9中的圆圈A的局部放大视图，其中密封组件从该剥离刀拆卸；Figure 10 is a partial enlarged view of circle A in Figure 9 with the seal assembly disassembled from the peel knife;
图11为图9中的圆圈A的局部分解立体图，其中密封组件从该剥离刀拆卸；Figure 11 is a partial exploded perspective view of circle A in Figure 9, with the seal assembly disassembled from the peeling knife;
图12为局部剥离刀的纵向截面图；以及Figure 12 is a longitudinal sectional view of a partial stripping knife; and
图13为沿着图9中的线I-I截取的横截面图；Fig. 13 is a cross-sectional view taken along line I-I among Fig. 9;
图14为根据本发明的具有防旋转装置的剥离刀的示意图；14 is a schematic diagram of a peeling knife with an anti-rotation device according to the present invention;
图15为沿着图14中的线I-I截取的横截面图；Fig. 15 is a cross-sectional view taken along the line I-I in Fig. 14;
图16根据本发明的具有防旋转装置的剥离刀的图14中的部分A的局部立体分解图；Fig. 16 is a partial perspective exploded view of part A in Fig. 14 of a stripping knife with an anti-rotation device according to the present invention;
图17为电极座、发射电极以及方形套管位于管鞘的通液腔内的状态的局部放大立体图；Fig. 17 is a partial enlarged perspective view of the state where the electrode seat, the emitting electrode and the square sleeve are located in the liquid passage cavity of the sheath;
图18为防旋转装置所在部位的放大截面图；Figure 18 is an enlarged cross-sectional view of the location of the anti-rotation device;
图19为根据本发明的具有螺旋结构的圈套器的侧视图；Figure 19 is a side view of a snare with a helical structure according to the present invention;
图20为根据本发明的具有螺旋结构的圈套器的图19中的圆圈A内的纵向剖视图；Fig. 20 is a longitudinal sectional view within circle A in Fig. 19 of a snare with a helical structure according to the present invention;
图21为螺旋结构附近的局部放大图；Figure 21 is a partial enlarged view near the helical structure;
图22为沿着图19中的线I-I截取的截面图。FIG. 22 is a cross-sectional view taken along line I-I in FIG. 19 .
具体实施方式Detailed ways
以下由特定的具体实施例说明本发明的实施方式，本领域技术人员可由本说明书所揭示的内容轻易地了解本发明的其他优点及功效。The implementation of the present invention will be illustrated by specific specific examples below, and those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification.
现在参考附图介绍本发明的示例性实施方式，然而，本发明可以用许多不同的形式来实施，并且不局限于此处描述的实施例，提供这些实施例是为了详尽地且完全地公开本发明，并且向所属技术领域的技术人员充分传达本发明的范围。对于表示在附图中的示例性实施方式中的术语并不是对本发明的限定。在附图中，相同的单元/元件使用相同的附图标记。Exemplary embodiments of the present invention will now be described with reference to the drawings; however, the present invention may be embodied in many different forms and are not limited to the embodiments described herein, which are provided for the purpose of exhaustively and completely disclosing the present invention. invention and fully convey the scope of the invention to those skilled in the art. The terms used in the exemplary embodiments shown in the drawings do not limit the present invention. In the figures, the same units/elements are given the same reference numerals.
除非另有说明，此处使用的术语(包括科技术语)对所属技术领域的技术人员具有通常的理解含义。另外，可以理解的是，以通常使用的词典限定的术语，应当被理解为与其相关领域的语境具有一致的含义，而不应该被理解为理想化的或过于正式的意义。Unless otherwise specified, the terms (including scientific and technical terms) used herein have the commonly understood meanings to those skilled in the art. In addition, it can be understood that terms defined by commonly used dictionaries should be understood to have consistent meanings in the context of their related fields, and should not be understood as idealized or overly formal meanings.
图1为根据本发明优选实施方式的等离子治疗仪100的功能示意图。等离子治疗仪100能够用于肠胃里面的诸如早癌的病变部位的剥离、消融和凝固与止血。此外，等离子治疗仪100还能够用于关节、脊柱、皮肤、耳鼻喉等外科手术中软组织的剥离、消融、凝固与止血。本申请的等离子治疗仪100使用时间为24 小时以内、按照接触时间分类属于暂时接触、按照接触人体性质分类属于外部接入器械(与组织/骨/牙本质)以及按照医疗器械结构特征分类属于有源医疗器械。等离子治疗仪100的附件双极手术电极(剥离刀) 头属于一次性无菌产品。Fig. 1 is a functional schematic diagram of a plasma therapy apparatus 100 according to a preferred embodiment of the present invention. The plasma therapy apparatus 100 can be used for peeling, ablation, coagulation and hemostasis of lesions such as early cancer in the stomach. In addition, the plasma therapy apparatus 100 can also be used for stripping, ablation, coagulation and hemostasis of soft tissues in surgical operations such as joints, spine, skin, and ENT. The plasma therapy instrument 100 of the present application is used within 24 hours, classified as temporary contact according to the contact time, classified as external access device (with tissue/bone/dentin) according to the nature of the contact with the human body, and classified according to the structural characteristics of the medical device as classified. Source medical devices. The accessory bipolar surgical electrode (stripping knife) head of the plasma therapy instrument 100 is a disposable sterile product.
等离子治疗仪100采用双极方案，并且其工作频率为110kHz。等离子治疗仪100通过等离子技术实现对耳鼻喉等手术中软组织的剥离、消融、凝固与止血。工作时，等离子治疗仪100通过生理盐水作为导电液，激活发射电极和回路电极之间时形成一个薄层。当等离子治疗仪100给予足够的能量(电压)时，生理盐水就转化为一个由赋能带电粒子组成的气体层(等离子层)。即，等离子治疗仪100利用能量激发导电介质(例如，生理盐水)产生等离子体，并且依靠等离子体的能量打断组织分子键。等离子体的能量将蛋白质等生物大分子直接裂解成O2，CO2，N2等气体，从而完成对组织的汽化剥离。当对等离子治疗仪 100的工作刀头给予低电压时，电场低于产生等离子层的域值要求并且产生组织电阻热，从而将组织进行消融凝固与止血。The plasma therapy apparatus 100 adopts a bipolar scheme, and its operating frequency is 110 kHz. The plasma therapy instrument 100 realizes stripping, ablation, coagulation and hemostasis of soft tissues in ENT and other operations through plasma technology. When working, the plasma therapeutic apparatus 100 uses physiological saline as a conductive liquid, and a thin layer is formed between the emitting electrode and the return electrode when activated. When sufficient energy (voltage) is applied to the plasma therapy apparatus 100, the saline solution is converted into a layer of gas (plasma layer) composed of energized charged particles. That is, the plasma therapy apparatus 100 excites the conductive medium (eg, physiological saline) with energy to generate plasma, and breaks the molecular bonds of tissues by the energy of the plasma. The energy of the plasma directly cracks the protein and other biomacromolecules into O2 , CO2 , N2 and other gases, thereby completing the vaporization and stripping of the tissue. When a low voltage is applied to the working cutter head of the plasma therapy apparatus 100, the electric field is lower than the threshold value requirement for generating a plasma layer and generates tissue resistance heat, thereby ablation, coagulation and hemostasis of the tissue.
如图1所示，等离子治疗仪100的功能体系结构包括：主控程序、报警单元、界面单元、输出控制单元、双极手术电极(剥离刀)接口、双极手术电极(剥离刀)、脚踏开关、脚控接口、滴液控制阀以及滴液控制阀接口。其中，主控程序、报警单元、界面单元、输出控制、双极手术电极接口、脚控接口以及滴液控制阀接口属于等离子治疗仪100的软件部分。等离子治疗仪100的部分部件的功能介绍如表1所示，As shown in Figure 1, the functional system structure of plasma therapy instrument 100 comprises: main control program, alarm unit, interface unit, output control unit, bipolar surgical electrode (stripping knife) interface, bipolar surgical electrode (stripping knife), feet Pedal switch, foot control interface, drip control valve and drip control valve interface. Among them, the main control program, alarm unit, interface unit, output control, bipolar surgical electrode interface, foot control interface and drip control valve interface belong to the software part of the plasma therapeutic apparatus 100 . The function introduction of some parts of the plasma therapy apparatus 100 is as shown in Table 1,
表1部分部件的功能介绍Table 1 Function introduction of some components
优选地，脚踏开关能够控制等离子治疗仪100的工作模式。等离子治疗仪100的工作模式分为剥离模式与凝血模式。脚踏开关的防水等级为防水等级标准IPX8，并且脚踏开关为电动脚踏开关。Preferably, the foot switch can control the working mode of the plasma therapeutic apparatus 100 . The working modes of the plasma therapy apparatus 100 are divided into stripping mode and coagulation mode. The waterproof level of the foot switch is IPX8, and the foot switch is an electric foot switch.
优选地，脚踏开关的黄色踏板对应于剥离模式，并且剥离模式的档位级别为1至9档。即，当踩踏脚踏开关的黄色踏板时，等离子治疗仪100进入剥离模式。剥离模式的档位调节方式为：在调节至剥离模式的状态下由脚踏开关上黑色按钮(或手动调节主机面板上黄色按钮)进行调节。剥离档位可以选择从1至 9档中的任意一档。其中，档位越高，输出电压越大。在剥离模式中，1至9档的输出电压如表2所示：Preferably, the yellow pedal of the foot switch corresponds to the stripping mode, and the gear levels of the stripping mode are 1 to 9 gears. That is, when the yellow pedal of the foot switch is stepped on, the plasma therapeutic apparatus 100 enters the peeling mode. The gear adjustment method of the peeling mode is: in the state of adjusting to the peeling mode, adjust by the black button on the foot switch (or manually adjust the yellow button on the main panel). The stripping gear can be selected from any one of the 1 to 9 gears. Among them, the higher the gear, the greater the output voltage. In stripping mode, the output voltages of gears 1 to 9 are shown in Table 2:
表2剥离模式中的输出档位Table 2 Output stalls in stripping mode
优选地，脚踏开关的蓝色踏板对应于凝血模式，并且凝血模式的档位级别为1至5档。即，当踩踏脚踏开关的蓝色踏板时，等离子治疗仪100进入凝血模式。凝血模式的档位调节方式为：在调节至凝血模式的状态下(按模式键可切换剥离模式和凝血模式)由蓝色踏板上黑色按钮(或手动调节主机面板上下蓝色按钮)进行调节。脚踏黑色按钮时，凝血档位可以选择从1至5档中的任意一档，其中档位越高输出电压越大。当临床使用中需要进行凝血时，踏下蓝色踏板进行凝血。在凝血模式中，1至5档的输出电压如表 3所示：Preferably, the blue pedal of the foot switch corresponds to the blood coagulation mode, and the gear levels of the blood coagulation mode are 1 to 5 gears. That is, when the blue pedal of the foot switch is stepped on, the plasma therapeutic apparatus 100 enters the coagulation mode. The gear adjustment method of the coagulation mode is: in the state of adjusting to the coagulation mode (press the mode button to switch between the stripping mode and the coagulation mode) to adjust by the black button on the blue pedal (or manually adjust the upper and lower blue buttons on the main panel). When the black button is pressed, the coagulation gear can be selected from any one of the 1 to 5 gears, and the higher the gear, the greater the output voltage. When blood coagulation is required in clinical use, step on the blue pedal for blood coagulation. In the blood coagulation mode, the output voltage of gears 1 to 5 is shown in Table 3:
表3凝血模式中的输出档位Table 3 Output gears in coagulation mode
优选地，脚控接口用于接收脚踏开关的控制指令，并且将所述控制指令转发给主控程序。其中，控制指令为二元组<模式，功率>。模式包括：剥离模式和凝血模式。在剥离模式中，功率包括9个档位，并且在凝血模式中，功率包括5个档位。Preferably, the foot control interface is used to receive control instructions of the foot switch, and forward the control instructions to the main control program. Wherein, the control instruction is a binary group <mode, power>. Modes include: stripping mode and coagulation mode. In peeling mode, the power includes 9 gears, and in coagulation mode, the power includes 5 gears.
优选地，主控程序对所述控制指令进行解析并且当所述控制指令指示第一模式时生成第一模式指令，根据当前阻抗和所述控制指令计算用于第一模式下的输出功率，将第一模式指令以及与所述第一模式下的输出功率相关联的第一电压指示发送给输出控制单元。其中，初始的当前阻抗为零，即在等离子治疗仪100开机进行操作时，默认的当前阻抗为零。所述主控程序对所述控制指令进行解析并且当所述控制指令指示第二模式时生成第二模式指令，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率，将第二模式指令以及与所述第二模式下的输出功率相关联的第二电压指示发送给输出控制单元。其中所述当前阻抗包括高阻抗、中阻抗和低阻抗(0阻抗为低阻抗)。优选地，根据当前阻抗和所述控制指令计算用于第一模式下的输出功率包括：如果当前阻抗为高阻抗并且所述控制指令指示第一模式下的第2 档，则将第一模式下的输出功率设置为第4档；如果当前阻抗为中阻抗并且所述控制指令指示第一模式下的第2档，则将第一模式下的输出功率设置为第3档；以及如果当前阻抗为低阻抗并且所述控制指令指示第一模式下的第2档，则将第一模式下的输出功率设置为第2档。优选地，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率包括：如果当前阻抗为高阻抗并且所述控制指令指示第二模式下的第2 档，则将第二模式下的输出功率设置为第4档；如果当前阻抗为中阻抗并且所述控制指令指示第二模式下的第2档，则将第二模式下的输出功率设置为第3档；以及如果当前阻抗为低阻抗并且所述控制指令指示第二模式下的第2档，则将第二模式下的输出功率设置为第2档。优选地，当所计算得到的输出功率超过第一模式或第二模式中的最高档位时，以最高档位作为实际输出功率。Preferably, the main control program analyzes the control instruction and generates the first mode instruction when the control instruction indicates the first mode, and calculates the output power for the first mode according to the current impedance and the control instruction, and will A first mode command and a first voltage indication associated with the output power in the first mode are sent to the output control unit. Wherein, the initial current impedance is zero, that is, when the plasma therapeutic apparatus 100 is turned on for operation, the default current impedance is zero. The main control program analyzes the control command and generates a second mode command when the control command indicates the second mode, calculates the output power for the second mode according to the current impedance and the control command, and converts the second The second mode command and the second voltage indication associated with the output power in the second mode are sent to the output control unit. The current impedance includes high impedance, medium impedance and low impedance (0 impedance is low impedance). Preferably, calculating the output power for the first mode according to the current impedance and the control instruction includes: if the current impedance is high impedance and the control instruction indicates the second gear in the first mode, then set the output power in the first mode to The output power of is set to the fourth gear; if the current impedance is medium impedance and the control instruction indicates the second gear in the first mode, then the output power in the first mode is set to the third gear; and if the current impedance is low impedance and the control command indicates the second gear in the first mode, then the output power in the first mode is set to the second gear. Preferably, calculating the output power for the second mode according to the current impedance and the control instruction includes: if the current impedance is high impedance and the control instruction indicates the second gear in the second mode, then set the output power in the second mode to The output power of is set to the fourth gear; if the current impedance is medium impedance and the control instruction indicates the second gear in the second mode, then the output power in the second mode is set to the third gear; and if the current impedance is low impedance and the control command indicates the second gear in the second mode, then the output power in the second mode is set to the second gear. Preferably, when the calculated output power exceeds the highest gear in the first mode or the second mode, the highest gear is used as the actual output power.
优选地，输出控制单元用于从所述主控程序接收第一模式指令和第一电压指示，并且将所述第一模式指令和第一电压指示转发给双极手术电极接口，以及从双极手术电极接口接收目标接触端的当前阻抗并且将所述当前阻抗发送给所述主控程序。以及所述输出控制单元从所述主控程序接收第二模式指令和第二电压指示，并且将所述第二模式指令和第二电压指示转发给双极手术电极接口。Preferably, the output control unit is configured to receive a first mode command and a first voltage indication from the main control program, and forward the first mode command and the first voltage indication to the bipolar surgical electrode interface, and from the bipolar A surgical electrode interface receives the current impedance of the target contact and sends the current impedance to the host program. And the output control unit receives a second mode command and a second voltage indication from the master control program, and forwards the second mode command and second voltage indication to a bipolar surgical electrode interface.
优选地，双极手术电极接口用于接收主控程序的功率指示并且将所述功率指示发送给双极手术电极，以及对双极手术电极的实时阻抗进行测量并且将所述实时阻抗通过输出控制单元传递给主控程序。Preferably, the bipolar surgical electrode interface is used to receive the power indication of the main control program and send the power indication to the bipolar surgical electrode, measure the real-time impedance of the bipolar surgical electrode and control the real-time impedance through the output The unit is passed to the master control program.
优选地，双极手术电极响应于从所述双极手术电极接口接收第一模式指令和第一电压指示，进入第一模式：通过导电介质在所述双极手术电极的目标接触端处的发射电极和回路电极之间进行电路激活以形成薄层，为发射电极和回路电极之间施加第一电压，使得所述导电介质达到第一温度并且被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化剥离。响应于从所述双极手术电极接口接收的第二指令和第二电压指示，所述双极手术电极进入第二模式：施加第二电压以将所述双极手术电极的目标接触端保持为第二温度，从而将目标体进行消融凝固。Preferably, the bipolar surgical electrode enters a first mode in response to receiving a first mode command and a first voltage indication from said bipolar surgical electrode interface: transmission via a conductive medium at a target contact end of said bipolar surgical electrode Activating a circuit between the electrode and the return electrode to form a thin layer, applying a first voltage between the emitter electrode and the return electrode, causing the conductive medium to reach a first temperature and being converted to a plasma layer, thereby exciting the conductive medium with electrical energy to produce Plasma, and the target body is vaporized and stripped based on the radio frequency energy of the plasma. In response to a second instruction received from the bipolar surgical electrode interface and a second voltage indication, the bipolar surgical electrode enters a second mode of applying a second voltage to maintain the target contact end of the bipolar surgical electrode at the second temperature, so as to ablate and solidify the target body.
优选地，报警单元用于在接收到报警信号时，通过声音提示、文字提示和/或指示灯显示进行报警。其中在所述双极手术电极检测到运行故障后向主控程序发送报警信号，所述主控程序将报警信号发送给所述报警单元。Preferably, the alarm unit is configured to issue an alarm through sound prompts, text prompts and/or indicator lights when an alarm signal is received. Wherein after the operation failure is detected by the bipolar surgical electrode, an alarm signal is sent to the main control program, and the main control program sends the alarm signal to the alarm unit.
优选地，界面单元，用于实时显示所述低温等离子剥离刀手术系统的运行状态。Preferably, the interface unit is used to display the operating status of the low-temperature plasma exfoliation knife surgery system in real time.
优选地，滴液控制阀用于基于所述主控程序的导电介质输入指令向双极手术电极输入所述导电介质，其中所述双极手术电极实时测量所述导电介质的当前余量并且将所述当前余量发送给主控程序，所述主控程序基于所述当前余量确定是否生成所述导电介质输入指令并且在确定生成所述导电介质输入指令后将所述导电介质输入指令发送给滴液控制阀。优选地，滴液控制阀接口用于实现滴液控制阀和主控程序之间的双向通信。Preferably, the drip control valve is used to input the conductive medium to the bipolar surgical electrode based on the conductive medium input instruction of the main control program, wherein the bipolar surgical electrode measures the current remaining amount of the conductive medium in real time and The current remaining amount is sent to a main control program, and the main control program determines whether to generate the conductive medium input instruction based on the current remaining amount and sends the conductive medium input instruction after determining to generate the conductive medium input instruction Give drip control valve. Preferably, the drip control valve interface is used to realize bidirectional communication between the drip control valve and the main control program.
优选地，双极手术电极末端导管处的发射电极、等离子层、回路电极以及目标接触端形成回路。在剥离模式中，双极手术电极的工作温度为35至40℃，而传统电外科刀的工作温度为350至700℃。双极手术电极的热穿透距离比传统电外科刀的热穿透距离小，其中剥离模式中的热穿透距离小于或等于150 微米并且凝血模式中的热穿透距离小于或等于200微米，而传统电外科刀的热穿透距离大于9000微米)。Preferably, the emitter electrode, the plasma layer, the return electrode and the target contact at the bipolar surgical electrode tip catheter form a loop. In peel mode, bipolar surgical electrodes operate at 35 to 40°C, compared to 350 to 700°C for conventional electrosurgical blades. The heat penetration distance of bipolar surgical electrodes is less than that of conventional electrosurgical blades, wherein the heat penetration distance in peeling mode is less than or equal to 150 microns and the heat penetration distance in coagulation mode is less than or equal to 200 microns, The heat penetration distance of traditional electric surgical knife is greater than 9000 microns).
等离子治疗仪100工作原理是等离子体低温消融术。利用双极刀头产生能量，将生理盐水转换成等离子体薄层，解离靶组织中构成细胞成分的分子键，造成组织凝固性坏死，形成消融或剥离的效果。由于在相对较低的温度下工作，比传统使用的高频剥离电刀对周边组织的热损伤降到最小程度。在35℃左右工作温度可使靶组织体积缩小，靶组织中的微血管封闭，切除病变。其低温和组织减容消融特性，较常用的单极电刀更具有缩短术后恢复时间、减轻术后疼痛和减少手术治疗费用的优点。其中，等离子治疗仪与普通高频剥离电刀的温度比较如表4所示：The working principle of the plasma therapy apparatus 100 is plasma low-temperature ablation. The bipolar cutter head is used to generate energy to convert physiological saline into a thin layer of plasma, which dissociates the molecular bonds that constitute the cell components in the target tissue, causing coagulation necrosis of the tissue, resulting in the effect of ablation or peeling. Because it works at a relatively low temperature, the thermal damage to surrounding tissues is minimized compared with the traditional high-frequency stripping electric knife. Working at around 35°C can reduce the volume of the target tissue, seal the microvessels in the target tissue, and resect the lesion. Its low temperature and tissue volume reduction and ablation characteristics have the advantages of shortening postoperative recovery time, reducing postoperative pain and reducing surgical treatment costs compared with commonly used monopolar electrocautery. Among them, the temperature comparison between the plasma therapy instrument and the ordinary high-frequency stripping electric knife is shown in Table 4:
表4Table 4
等离子治疗仪在工作时刀头周围温度低于70℃(详见离体实验研究组织热损伤报告)，与传统意义上的普通高频剥离电刀(100～150℃高温)相比工作温度更低，虽然低温等离子刀的治疗温度相对人组织仍属于高温，组织细胞受此温度影响后，同样会出现电刀剥离造成组织蛋白变性，尤其是持续一定时间后，亦可对组织造成热损伤。而组织细胞的变性坏死是一个逐渐发展的过程，故部分患者行低温等离子手术后，其术区肿胀、术后疼痛等反应不比高频剥离电刀反应轻。等离子治疗仪与普通高频剥离电刀的损伤热损伤深度比较如下表5所示：The temperature around the cutter head of the plasma therapy instrument is lower than 70°C when it is working (see the report on tissue thermal damage in vitro experiments for details), which is higher than that of ordinary high-frequency stripping electric scalpels (100-150°C high temperature) in the traditional sense. Low, although the treatment temperature of low-temperature plasma knife is still high temperature compared with human tissue, after tissue cells are affected by this temperature, tissue protein denaturation will also occur due to electric knife stripping, especially after a certain period of time, it can also cause thermal damage to tissue. The degeneration and necrosis of tissue cells is a gradual process, so after low-temperature plasma surgery in some patients, the swelling and postoperative pain in the operative area are not as severe as those of high-frequency stripping electrosurgical surgery. The comparison of the thermal damage depth between the plasma therapy instrument and the ordinary high-frequency peeling electric knife is shown in Table 5 below:
表5table 5
由于每次手术时间存在差异所以等离子治疗仪在离体实验研究组织热损伤报告中选用了最大手术时间，由对比可见最大手术时间的等离子治疗仪和正常使用的高频剥离电刀热损深度。故正常使用的等离子治疗仪的热损深度应低于高频剥离电刀热损深度。Due to the difference in the operation time of each operation, the plasma therapy device selected the maximum operation time in the report of the in vitro experimental research on tissue thermal damage. The comparison shows that the plasma therapy device with the maximum operation time and the heat damage depth of the high-frequency stripping electric knife in normal use. Therefore, the heat damage depth of the normal use plasma therapy instrument should be lower than the heat damage depth of the high-frequency peeling electrosurgical knife.
图2为根据本发明优选实施方式的等离子治疗仪200的主要零件示意图。如图2所示，等离子治疗仪200 的主要零件包括：双极手术电极接口201、滴液控制阀接口202、踩踏开关接口203、显示屏204、主板205、喇叭206、前面板207、故障报警灯208、下模209、上模210、电源模块211、滴液控制阀212以及风扇213。Fig. 2 is a schematic diagram of main parts of a plasma therapy apparatus 200 according to a preferred embodiment of the present invention. As shown in Figure 2, the main parts of the plasma therapy apparatus 200 include: bipolar surgical electrode interface 201, drip control valve interface 202, pedal switch interface 203, display screen 204, main board 205, speaker 206, front panel 207, fault alarm Lamp 208, lower die 209, upper die 210, power module 211, drip control valve 212 and fan 213.
优选地，踩踏开关接口203用于接收脚踏开关的指令，脚踏开关并且能够控制等离子治疗仪200的工作模式。等离子治疗仪200的工作模式分为剥离模式与凝血模式。脚踏开关的防水等级为防水等级标准IPX8，并且脚踏开关为电动脚踏开关。Preferably, the pedal switch interface 203 is used to receive instructions from the pedal switch, and the pedal switch can control the working mode of the plasma therapeutic apparatus 200 . The working modes of the plasma therapy apparatus 200 are divided into stripping mode and coagulation mode. The waterproof level of the foot switch is IPX8, and the foot switch is an electric foot switch.
优选地，脚踏开关的黄色踏板对应于剥离模式，并且剥离模式的档位级别为1至9档。即，当踩踏脚踏开关的黄色踏板时，等离子治疗仪200进入剥离模式。剥离模式的档位调节方式为：在调节至剥离模式的状态下由脚踏开关上黑色按钮(或手动调节主机面板上黄色按钮)进行调节。剥离档位可以选择从1至9档中的任意一档。其中，档位越高，输出电压越大。Preferably, the yellow pedal of the foot switch corresponds to the stripping mode, and the gear levels of the stripping mode are 1 to 9 gears. That is, when the yellow pedal of the foot switch is stepped on, the plasma therapeutic apparatus 200 enters the peeling mode. The gear adjustment method of the peeling mode is: in the state of adjusting to the peeling mode, adjust by the black button on the foot switch (or manually adjust the yellow button on the main panel). The stripping gear can be selected from any one of gears 1 to 9. Among them, the higher the gear, the greater the output voltage.
优选地，脚踏开关的蓝色踏板对应于凝血模式，并且凝血模式的档位级别为1至5档。即，当踩踏脚踏开关的蓝色踏板时，等离子治疗仪200进入凝血模式。凝血模式的档位调节方式为：在调节至凝血模式的状态下(按模式键可切换剥离模式和凝血模式)由蓝色踏板上黑色按钮(或手动调节主机面板上下蓝色按钮)进行调节。脚踏黑色按钮时，凝血档位可以选择从1至5档中的任意一档，其中档位越高输出电压越大。当临床使用中需要进行凝血时，踏下蓝色踏板进行凝血。Preferably, the blue pedal of the foot switch corresponds to the blood coagulation mode, and the gear levels of the blood coagulation mode are 1 to 5 gears. That is, when the blue pedal of the foot switch is stepped on, the plasma therapeutic apparatus 200 enters the coagulation mode. The gear adjustment method of the coagulation mode is: in the state of adjusting to the coagulation mode (press the mode button to switch between the stripping mode and the coagulation mode) to adjust by the black button on the blue pedal (or manually adjust the upper and lower blue buttons on the main panel). When the black button is pressed, the coagulation gear can be selected from any one of the 1 to 5 gears, and the higher the gear, the greater the output voltage. When blood coagulation is required in clinical use, step on the blue pedal for blood coagulation.
优选地，踩踏开关接口203用于接收脚踏开关的控制指令，并且将所述控制指令转发给主控程序。其中，控制指令为二元组<模式，功率>。模式包括：剥离模式和凝血模式。在剥离模式中，功率包括9个档位，并且在凝血模式中，功率包括5个档位。Preferably, the pedal switch interface 203 is used to receive control instructions of the foot switch, and forward the control instructions to the main control program. Wherein, the control instruction is a binary group <mode, power>. Modes include: stripping mode and coagulation mode. In peeling mode, the power includes 9 gears, and in coagulation mode, the power includes 5 gears.
优选地，主板205用于容纳固件，所述固件中存储主控程序。其中，主控程序对所述控制指令进行解析并且当所述控制指令指示第一模式时生成第一模式指令，根据当前阻抗和所述控制指令计算用于第一模式下的输出功率，将第一模式指令以及与所述第一模式下的输出功率相关联的第一电压指示发送给输出控制单元。其中，初始的当前阻抗为零，即在等离子治疗仪200开机进行操作时，默认的当前阻抗为零。所述主控程序对所述控制指令进行解析并且当所述控制指令指示第二模式时生成第二模式指令，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率，将第二模式指令以及与所述第二模式下的输出功率相关联的第二电压指示发送给输出控制单元。其中所述当前阻抗包括高阻抗、中阻抗和低阻抗 (0阻抗为低阻抗)。优选地，根据当前阻抗和所述控制指令计算用于第一模式下的输出功率包括：如果当前阻抗为高阻抗并且所述控制指令指示第一模式下的第2档，则将第一模式下的输出功率设置为第4 档；如果当前阻抗为中阻抗并且所述控制指令指示第一模式下的第2档，则将第一模式下的输出功率设置为第3档；以及如果当前阻抗为低阻抗并且所述控制指令指示第一模式下的第2档，则将第一模式下的输出功率设置为第2档。优选地，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率包括：如果当前阻抗为高阻抗并且所述控制指令指示第二模式下的第2档，则将第二模式下的输出功率设置为第4 档；如果当前阻抗为中阻抗并且所述控制指令指示第二模式下的第2档，则将第二模式下的输出功率设置为第3档；以及如果当前阻抗为低阻抗并且所述控制指令指示第二模式下的第2档，则将第二模式下的输出功率设置为第2档。优选地，当所计算得到的输出功率超过第一模式或第二模式中的最高档位时，以最高档位作为实际输出功率。Preferably, the main board 205 is used to accommodate firmware, and the main control program is stored in the firmware. Wherein, the main control program analyzes the control instruction and generates the first mode instruction when the control instruction indicates the first mode, calculates the output power for the first mode according to the current impedance and the control instruction, and converts the second A mode command and a first voltage indication associated with the output power in the first mode are sent to the output control unit. Wherein, the initial current impedance is zero, that is, when the plasma therapeutic apparatus 200 is turned on for operation, the default current impedance is zero. The main control program analyzes the control command and generates a second mode command when the control command indicates the second mode, calculates the output power for the second mode according to the current impedance and the control command, and converts the second The second mode command and the second voltage indication associated with the output power in the second mode are sent to the output control unit. The current impedance includes high impedance, medium impedance and low impedance (0 impedance is low impedance). Preferably, calculating the output power for the first mode according to the current impedance and the control instruction includes: if the current impedance is high impedance and the control instruction indicates the second gear in the first mode, then set the output power in the first mode to The output power of the first mode is set to the fourth gear; if the current impedance is medium impedance and the control instruction indicates the second gear in the first mode, the output power in the first mode is set to the third gear; and if the current impedance is low impedance and the control command indicates the second gear in the first mode, then the output power in the first mode is set to the second gear. Preferably, calculating the output power used in the second mode according to the current impedance and the control instruction includes: if the current impedance is high impedance and the control instruction indicates the second gear in the second mode, setting the output power in the second mode to The output power of is set to the fourth gear; if the current impedance is medium impedance and the control instruction indicates the second gear in the second mode, then the output power in the second mode is set to the third gear; and if the current impedance is low impedance and the control command indicates the second gear in the second mode, then the output power in the second mode is set to the second gear. Preferably, when the calculated output power exceeds the highest gear in the first mode or the second mode, the highest gear is used as the actual output power.
优选地，输出控制单元(图2中未示出)用于从所述主控程序接收第一模式指令和第一电压指示，并且将所述第一模式指令和第一电压指示转发给双极手术电极接口201，以及从双极手术电极接口201接收目标接触端的当前阻抗并且将所述当前阻抗发送给所述主控程序。以及所述输出控制单元从所述主控程序接收第二模式指令和第二电压指示，并且将所述第二模式指令和第二电压指示转发给双极手术电极接口201。Preferably, an output control unit (not shown in FIG. 2 ) is configured to receive a first mode command and a first voltage indication from the main control program, and forward the first mode command and the first voltage indication to the bipolar The surgical electrode interface 201, and receiving the current impedance of the target contact from the bipolar surgical electrode interface 201 and sending the current impedance to the main control program. And the output control unit receives the second mode command and the second voltage indication from the main control program, and forwards the second mode command and the second voltage indication to the bipolar surgical electrode interface 201 .
优选地，双极手术电极接口201用于接收主控程序的功率指示并且将所述功率指示发送给双极手术电极，以及对双极手术电极的实时阻抗进行测量并且将所述实时阻抗通过输出控制单元传递给主控程序。Preferably, the bipolar surgical electrode interface 201 is used for receiving the power indication of the main control program and sending the power indication to the bipolar surgical electrode, and measuring the real-time impedance of the bipolar surgical electrode and outputting the real-time impedance The control unit is passed to the main control program.
优选地，双极手术电极(图中未示出)响应于从所述双极手术电极接口201接收第一模式指令和第一电压指示，进入第一模式：通过导电介质在所述双极手术电极的目标接触端处的发射电极和回路电极之间进行电路激活以形成薄层，为发射电极和回路电极之间施加第一电压，使得所述导电介质达到第一温度并且被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化剥离。响应于从所述双极手术电极接口201接收的第二指令和第二电压指示，所述双极手术电极进入第二模式：施加第二电压以将所述双极手术电极的目标接触端保持为第二温度，从而将目标体进行消融凝固。Preferably, the bipolar surgical electrode (not shown in the figure) enters the first mode in response to receiving a first mode command and a first voltage indication from the bipolar surgical electrode interface 201: Activating a circuit between the emitter electrode and the return electrode at the target contact end of the electrodes to form a thin layer, applying a first voltage between the emitter electrode and the return electrode such that the conductive medium reaches a first temperature and is converted into a plasma layer , so that electric energy is used to excite the conductive medium to generate plasma, and the target body is vaporized and stripped based on the radio frequency energy of the plasma. In response to a second instruction received from the bipolar surgical electrode interface 201 and a second voltage indication, the bipolar surgical electrode enters a second mode: applying a second voltage to hold the target contact end of the bipolar surgical electrode is the second temperature, so that the target body is ablated and solidified.
优选地，故障报警灯208用于在接收到报警信号时，通过指示灯显示进行报警。其中在所述双极手术电极检测到运行故障后向主控程序发送报警信号，所述主控程序将报警信号发送给所述故障报警灯208。喇叭206用于在接收到报警信号时，通过声音进行报警。其中在所述双极手术电极检测到运行故障后向主控程序发送报警信号，所述主控程序将报警信号发送给所述喇叭206。Preferably, the fault alarm light 208 is used to give an alarm through indicator light display when an alarm signal is received. Wherein, after the bipolar surgical electrode detects an operation failure, an alarm signal is sent to the main control program, and the main control program sends the alarm signal to the failure alarm lamp 208 . The horn 206 is used to give an alarm by sound when an alarm signal is received. Wherein, after the bipolar surgical electrode detects an operation failure, an alarm signal is sent to the main control program, and the main control program sends the alarm signal to the horn 206 .
优选地，显示屏204用于实时显示所述低温等离子剥离刀手术系统的运行状态。Preferably, the display screen 204 is used to display the operating status of the low-temperature plasma peeling knife surgery system in real time.
优选地，滴液控制阀212用于基于所述主控程序的导电介质输入指令向双极手术电极输入所述导电介质，其中所述双极手术电极实时测量所述导电介质的当前余量并且将所述当前余量发送给主控程序，所述主控程序基于所述当前余量确定是否生成所述导电介质输入指令并且在确定生成所述导电介质输入指令后将所述导电介质输入指令发送给滴液控制阀212。优选地，滴液控制阀接口202用于实现滴液控制阀 212和主控程序之间的双向通信。Preferably, the drip control valve 212 is used to input the conductive medium to the bipolar surgical electrode based on the conductive medium input instruction of the main control program, wherein the bipolar surgical electrode measures the current remaining amount of the conductive medium in real time and Sending the current balance to a main control program, the main control program determines whether to generate the conductive medium input instruction based on the current balance and sends the conductive medium input instruction after determining to generate the conductive medium input instruction Send to drip control valve 212. Preferably, the drip control valve interface 202 is used to realize two-way communication between the drip control valve 212 and the main control program.
优选地，本申请采用双模式液体出口：1、滴定模式，即像吊瓶输液的方式一样一滴一滴的供给；以及2、连续供给模式，即连续供应液体流的模式。双极手术电极接口(剥离刀接口)通过插接线与如下所述的图5的双极电极插口接头(剥离刀接头)连接，滴液控制阀接口通过连接管与图5的通液腔连接。脚踏开关口通过连接线与外置的脚踏板连接，用来控制能量和滴液的供应和断开。当脚踏板踩下时，能量和滴液供应；当脚踏板松开时，能量和滴液断开。Preferably, the present application adopts a dual-mode liquid outlet: 1. Titration mode, that is, a drop-by-drop supply like a bottle infusion; and 2. Continuous supply mode, that is, a continuous supply of liquid flow. The bipolar surgical electrode interface (stripping knife interface) is connected to the bipolar electrode socket joint (stripping knife joint) of Figure 5 as described below through a plug-in wire, and the drip control valve interface is connected to the liquid passage chamber of Figure 5 through a connecting tube. The foot switch port is connected with an external foot pedal through a connecting line to control the supply and disconnection of energy and dripping liquid. When the pedal is depressed, power and drip are supplied; when the pedal is released, power and drip are disconnected.
优选地，双极手术电极末端导管处的发射电极、等离子层、回路电极以及目标接触端形成回路。在剥离模式中，双极手术电极的工作温度为35至40℃，而传统电外科刀的工作温度为350至700℃。双极手术电极的热穿透距离比传统电外科刀的热穿透距离小，其中剥离模式中的热穿透距离小于或等于150 微米并且凝血模式中的热穿透距离小于或等于200微米，而传统电外科刀的热穿透距离大于9000微米。Preferably, the emitter electrode, the plasma layer, the return electrode and the target contact at the bipolar surgical electrode tip catheter form a loop. In peel mode, bipolar surgical electrodes operate at 35 to 40°C, compared to 350 to 700°C for conventional electrosurgical blades. The heat penetration distance of bipolar surgical electrodes is less than that of conventional electrosurgical blades, wherein the heat penetration distance in peeling mode is less than or equal to 150 microns and the heat penetration distance in coagulation mode is less than or equal to 200 microns, The heat penetration distance of traditional electric surgical knife is greater than 9000 microns.
优选地，上模210和下模209通过组合的方式来保护主板。风扇213用于散热，并且电源模块211用于为等离子治疗仪200提供电力。前面板207用于进行数据显示和操作控制。Preferably, the upper mold 210 and the lower mold 209 are combined to protect the main board. The fan 213 is used for heat dissipation, and the power supply module 211 is used for providing power for the plasma therapeutic apparatus 200 . The front panel 207 is used for data display and operation control.
图3为根据本发明优选实施方式的低温等离子剥离刀手术系统300的结构示意图。低温等离子剥离刀手术系统300能够用于肠胃里面的诸如早癌的病变部位的剥离、消融和凝固与止血。此外，低温等离子剥离刀手术系统300还能够用于关节、脊柱、皮肤、耳鼻喉等外科手术中软组织的剥离、消融、凝固与止血。本申请的低温等离子剥离刀手术系统300使用时间为24小时以内、按照接触时间分类属于暂时接触、按照接触人体性质分类属于外部接入器械(与组织/骨/牙本质)以及按照医疗器械结构特征分类属于有源医疗器械。Fig. 3 is a schematic structural diagram of a low-temperature plasma exfoliation knife surgery system 300 according to a preferred embodiment of the present invention. The low-temperature plasma stripping knife surgery system 300 can be used for stripping, ablation, coagulation and hemostasis of lesions such as early cancer in the stomach. In addition, the low-temperature plasma stripping knife surgery system 300 can also be used for stripping, ablation, coagulation, and hemostasis of soft tissues in surgical operations such as joints, spine, skin, and ear, nose, and throat. The low-temperature plasma peeling knife surgery system 300 of the present application is used within 24 hours, classified as temporary contact according to the contact time, classified as external access device (with tissue/bone/dentin) according to the nature of contact with the human body, and classified according to the structural characteristics of medical devices Classification belongs to active medical devices.
低温等离子剥离刀手术系统300采用双极方案，并且其工作频率为110kHz。低温等离子剥离刀手术系统300通过等离子技术实现对耳鼻喉等手术中软组织的剥离、消融、凝固与止血。工作时，低温等离子剥离刀手术系统300通过生理盐水作为导电液，激活发射电极和回路电极之间时形成一个薄层。当低温等离子剥离刀手术系统300给予足够的能量(电压)时，生理盐水就转化为一个由赋能带电粒子组成的气体层(等离子层)。即，低温等离子剥离刀手术系统300利用能量激发导电介质(例如，生理盐水)产生等离子体，并且依靠等离子体的能量打断组织分子键。等离子体的能量将蛋白质等生物大分子直接裂解成O2， CO2，N2等气体，从而完成对组织的汽化剥离。当对等离子治疗仪100的工作刀头给予低电压时，电场低于产生等离子层的域值要求并且产生组织电阻热，从而将组织进行消融凝固与止血。The low-temperature plasma peeling knife surgery system 300 adopts a bipolar scheme, and its operating frequency is 110 kHz. The low-temperature plasma stripping knife surgery system 300 realizes stripping, ablation, coagulation and hemostasis of soft tissues in ENT and other surgeries through plasma technology. During operation, the low-temperature plasma exfoliation knife surgery system 300 uses physiological saline as a conductive liquid, and a thin layer is formed between the emitting electrode and the return electrode when activated. When sufficient energy (voltage) is applied to the low-temperature plasma peeling knife surgery system 300, the physiological saline is converted into a gas layer (plasma layer) composed of energized charged particles. That is, the low-temperature plasma exfoliation knife surgery system 300 uses energy to excite a conductive medium (for example, physiological saline) to generate plasma, and relies on the energy of the plasma to break tissue molecular bonds. The energy of the plasma directly cracks the protein and other biomacromolecules into O2 , CO2 , N2 and other gases, thereby completing the vaporization and stripping of the tissue. When a low voltage is applied to the working cutter head of the plasma therapy apparatus 100, the electric field is lower than the threshold value requirement for generating a plasma layer and generates tissue resistance heat, thereby ablation, coagulation and hemostasis of the tissue.
如图3所示，低温等离子剥离刀手术系统300包括：输入单元301、控制单元302、接口单元303、等离子单元304、报警单元305、滴液输入单元306以及显示单元307。优选地，输入单元301例如是脚踏开关，并且脚踏开关能够控制低温等离子剥离刀手术系统300工作模式。低温等离子剥离刀手术系统300的工作模式分为剥离模式与凝血模式。脚踏开关的防水等级为防水等级标准IPX8，并且脚踏开关为电动脚踏开关。As shown in FIG. 3 , the low temperature plasma exfoliation knife surgery system 300 includes: an input unit 301 , a control unit 302 , an interface unit 303 , a plasma unit 304 , an alarm unit 305 , a drip input unit 306 and a display unit 307 . Preferably, the input unit 301 is, for example, a foot switch, and the foot switch can control the working mode of the low temperature plasma exfoliation knife surgery system 300 . The working modes of the low-temperature plasma stripping knife surgery system 300 are divided into stripping mode and coagulation mode. The waterproof level of the foot switch is IPX8, and the foot switch is an electric foot switch.
优选地，脚踏开关的黄色踏板对应于剥离模式，并且剥离模式的档位级别为1至9档。即，当踩踏脚踏开关的黄色踏板时，低温等离子剥离刀手术系统300进入剥离模式。剥离模式的档位调节方式为：在调节至剥离模式的状态下由脚踏开关上黑色按钮(或手动调节主机面板上黄色按钮)进行调节。剥离档位可以选择从1至9档中的任意一档。其中，档位越高，输出电压越大。Preferably, the yellow pedal of the foot switch corresponds to the stripping mode, and the gear levels of the stripping mode are 1 to 9 gears. That is, when the yellow pedal of the foot switch is stepped on, the low temperature plasma exfoliation knife surgery system 300 enters the exfoliation mode. The gear adjustment method of the peeling mode is: in the state of adjusting to the peeling mode, adjust by the black button on the foot switch (or manually adjust the yellow button on the main panel). The stripping gear can be selected from any one of gears 1 to 9. Among them, the higher the gear, the greater the output voltage.
优选地，脚踏开关的蓝色踏板对应于凝血模式，并且凝血模式的档位级别为1至5档。即，当踩踏脚踏开关的蓝色踏板时，低温等离子剥离刀手术系统300进入凝血模式。凝血模式的档位调节方式为：在调节至凝血模式的状态下(按模式键可切换剥离模式和凝血模式)由蓝色踏板上黑色按钮(或手动调节主机面板上下蓝色按钮)进行调节。脚踏黑色按钮时，凝血档位可以选择从1至5档中的任意一档，其中档位越高输出电压越大。当临床使用种需要进行凝血时，踏下蓝色踏板进行凝血。Preferably, the blue pedal of the foot switch corresponds to the blood coagulation mode, and the gear levels of the blood coagulation mode are 1 to 5 gears. That is, when the blue pedal of the foot switch is stepped on, the low temperature plasma excision knife surgery system 300 enters the coagulation mode. The gear adjustment method of the coagulation mode is: in the state of adjusting to the coagulation mode (press the mode button to switch between the stripping mode and the coagulation mode) to adjust by the black button on the blue pedal (or manually adjust the upper and lower blue buttons on the main panel). When the black button is pressed, the coagulation gear can be selected from any one of the 1 to 5 gears, and the higher the gear, the greater the output voltage. When blood coagulation is required for clinical use, step on the blue pedal to carry out blood coagulation.
优选地，脚控接口用于接收脚踏开关的控制指令，并且将所述控制指令转发给主控程序。其中，控制指令为二元组<模式，功率>。模式包括：剥离模式和凝血模式。在剥离模式中，功率包括9个档位，并且在凝血模式中，功率包括5个档位。Preferably, the foot control interface is used to receive control instructions of the foot switch, and forward the control instructions to the main control program. Wherein, the control instruction is a binary group <mode, power>. Modes include: stripping mode and coagulation mode. In peeling mode, the power includes 9 gears, and in coagulation mode, the power includes 5 gears.
优选地，控制单元302对所述控制指令进行解析并且当所述控制指令指示第一模式时生成第一模式指令，根据当前阻抗和所述控制指令计算用于第一模式下的输出功率，将第一模式指令以及与所述第一模式下的输出功率相关联的第一电压指示发送给接口单元303。其中，初始的当前阻抗为零，即在低温等离子剥离刀手术系统300开机进行操作时，默认的当前阻抗为零。所述控制单元302对所述控制指令进行解析并且当所述控制指令指示第二模式时生成第二模式指令，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率，将第二模式指令以及与所述第二模式下的输出功率相关联的第二电压指示发送给接口单元 303。其中所述当前阻抗包括高阻抗、中阻抗和低阻抗(0阻抗为低阻抗)。优选地，根据当前阻抗和所述控制指令计算用于第一模式下的输出功率包括：如果当前阻抗为高阻抗并且所述控制指令指示第一模式下的第2档，则将第一模式下的输出功率设置为第4档；如果当前阻抗为中阻抗并且所述控制指令指示第一模式下的第2档，则将第一模式下的输出功率设置为第3档；以及如果当前阻抗为低阻抗并且所述控制指令指示第一模式下的第2档，则将第一模式下的输出功率设置为第2档。优选地，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率包括：如果当前阻抗为高阻抗并且所述控制指令指示第二模式下的第2档，则将第二模式下的输出功率设置为第4档；如果当前阻抗为中阻抗并且所述控制指令指示第二模式下的第2档，则将第二模式下的输出功率设置为第3档；以及如果当前阻抗为低阻抗并且所述控制指令指示第二模式下的第2档，则将第二模式下的输出功率设置为第2档。优选地，当所计算得到的输出功率超过第一模式或第二模式中的最高档位时，以最高档位作为实际输出功率。Preferably, the control unit 302 analyzes the control instruction and generates the first mode instruction when the control instruction indicates the first mode, and calculates the output power for the first mode according to the current impedance and the control instruction, and will The first mode command and the first voltage indication associated with the output power in the first mode are sent to the interface unit 303 . Wherein, the initial current impedance is zero, that is, the default current impedance is zero when the low-temperature plasma peeling knife surgery system 300 is powered on for operation. The control unit 302 analyzes the control instruction and generates a second mode instruction when the control instruction indicates the second mode, calculates the output power for the second mode according to the current impedance and the control instruction, and converts the second The second mode command and the second voltage indication associated with the output power in the second mode are sent to the interface unit 303 . The current impedance includes high impedance, medium impedance and low impedance (0 impedance is low impedance). Preferably, calculating the output power for the first mode according to the current impedance and the control instruction includes: if the current impedance is high impedance and the control instruction indicates the second gear in the first mode, then set the output power in the first mode to The output power of is set to the fourth gear; if the current impedance is medium impedance and the control instruction indicates the second gear in the first mode, then the output power in the first mode is set to the third gear; and if the current impedance is low impedance and the control command indicates the second gear in the first mode, then the output power in the first mode is set to the second gear. Preferably, calculating the output power used in the second mode according to the current impedance and the control instruction includes: if the current impedance is high impedance and the control instruction indicates the second gear in the second mode, setting the output power in the second mode to The output power of is set to the fourth gear; if the current impedance is medium impedance and the control instruction indicates the second gear in the second mode, then the output power in the second mode is set to the third gear; and if the current impedance is low impedance and the control command indicates the second gear in the second mode, then the output power in the second mode is set to the second gear. Preferably, when the calculated output power exceeds the highest gear in the first mode or the second mode, the highest gear is used as the actual output power.
优选地，接口单元303用于从所述控制单元302接收第一模式指令和第一电压指示，并且将所述第一模式指令和第一电压指示转发给等离子单元304，以及从等离子单元304接收目标接触端的当前阻抗并且将所述当前阻抗发送给所述控制单元302。以及所述接口单元303从所述控制单元302接收第二模式指令和第二电压指示，并且将所述第二模式指令和第二电压指示转发给等离子单元304。Preferably, the interface unit 303 is used to receive the first mode command and the first voltage indication from the control unit 302, and forward the first mode command and the first voltage indication to the plasma unit 304, and receive from the plasma unit 304 target the current impedance of the contact end and send the current impedance to the control unit 302 . And the interface unit 303 receives the second mode command and the second voltage indication from the control unit 302 , and forwards the second mode command and the second voltage indication to the plasma unit 304 .
优选地，接口单元303用于接收控制单元302的功率指示并且将所述功率指示发送给等离子单元304，以及对等离子单元304的实时阻抗进行测量并且将所述实时阻抗通过接口单元303传递给控制单元302。Preferably, the interface unit 303 is used to receive the power indication of the control unit 302 and send the power indication to the plasma unit 304, measure the real-time impedance of the plasma unit 304 and transmit the real-time impedance to the control unit 303 through the interface unit 303. Unit 302.
优选地，等离子单元304响应于从所述等离子单元304接收第一模式指令和第一电压指示，进入第一模式：通过导电介质在所述等离子单元304的目标接触端处的发射电极和回路电极之间进行电路激活以形成薄层，为发射电极和回路电极之间施加第一电压，使得所述导电介质达到第一温度并且被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化剥离。响应于从所述等离子单元304接收的第二指令和第二电压指示，所述等离子单元304进入第二模式：施加第二电压以将所述等离子单元304的目标接触端保持为第二温度，从而将目标体进行消融凝固。Preferably, the plasma cell 304 enters a first mode in response to receiving a first mode instruction and a first voltage indication from said plasma cell 304: emitter electrode and return electrode at a target contact end of said plasma cell 304 through a conductive medium A circuit is activated to form a thin layer, a first voltage is applied between the emitter electrode and the return electrode, so that the conductive medium reaches a first temperature and is converted into a plasma layer, thereby exciting the conductive medium with electrical energy to generate a plasma, and The target body is vaporized and stripped based on the radio frequency energy of the plasma. In response to a second instruction received from the plasma cell 304 and an indication of a second voltage, the plasma cell 304 enters a second mode of applying a second voltage to maintain a target contact of the plasma cell 304 at a second temperature, Thus, the target body is ablated and solidified.
优选地，报警单元305用于在接收到报警信号时，通过声音提示、文字提示和/或指示灯显示进行报警。其中在所述等离子单元304检测到运行故障后向控制单元302发送报警信号，所述控制单元302将报警信号发送给所述报警单元305。Preferably, the alarm unit 305 is configured to issue an alarm through sound prompts, text prompts and/or indicator lights when an alarm signal is received. Wherein, after the plasma unit 304 detects an operation failure, it sends an alarm signal to the control unit 302 , and the control unit 302 sends the alarm signal to the alarm unit 305 .
优选地，滴液输入单元306用于基于所述控制单元302的导电介质输入指令向等离子单元304输入所述导电介质，其中所述等离子单元304实时测量所述导电介质的当前余量并且将所述当前余量发送给控制单元302，所述控制单元302基于所述当前余量确定是否生成所述导电介质输入指令并且在确定生成所述导电介质输入指令后将所述导电介质输入指令发送给滴液输入单元306。Preferably, the drip input unit 306 is configured to input the conductive medium to the plasma unit 304 based on the conductive medium input command of the control unit 302, wherein the plasma unit 304 measures the current remaining amount of the conductive medium in real time and converts the The current remaining amount is sent to the control unit 302, and the control unit 302 determines whether to generate the conductive medium input instruction based on the current remaining amount and sends the conductive medium input instruction to the Droplet input unit 306 .
优选地，等离子单元304末端导管处的发射电极、等离子层、回路电极以及目标接触端形成回路。在剥离模式中，等离子单元304的工作温度为35至40℃，而传统电外科刀的工作温度为350至700℃。等离子单元304的热穿透距离比传统电外科刀的热穿透距离小，其中剥离模式中的热穿透距离小于或等于 150微米并且凝血模式中的热穿透距离小于或等于200微米，而传统电外科刀的热穿透距离大于9000微米。Preferably, the emitter electrode, the plasma layer, the return electrode and the target contact end at the end conduit of the plasma cell 304 form a loop. In peeling mode, the operating temperature of the plasma unit 304 is 35 to 40°C, while the operating temperature of a conventional electrosurgical knife is 350 to 700°C. The heat penetration distance of the plasma unit 304 is smaller than that of a conventional electrosurgical knife, wherein the heat penetration distance in the peeling mode is less than or equal to 150 microns and the heat penetration distance in the coagulation mode is less than or equal to 200 microns, while The heat penetration distance of traditional electrosurgical scalpels is greater than 9000 microns.
优选地，显示单元307，用于实时显示所述低温等离子剥离刀手术系统的运行状态。低温等离子剥离刀手术系统300工作原理是等离子体低温消融术。利用双极刀头产生能量，将生理盐水转换成等离子体薄层，解离靶组织中构成细胞成分的分子键，造成组织凝固性坏死，形成消融或剥离的效果。由于在相对较低的温度下工作，比传统使用的高频剥离电刀对周边组织的热损伤降到最小程度。在35℃左右工作温度可使靶组织体积缩小，靶组织中的微血管封闭，切除病变。其低温和组织减容消融特性，较常用的单极电刀更具有缩短术后恢复时间、减轻术后疼痛和减少手术治疗费用的优点。低温等离子剥离刀手术系统300在工作时刀头周围温度低于70℃(详见离体实验研究组织热损伤报告)，与传统意义上的普通高频剥离电刀 (100～150℃高温)相比工作温度更低，虽然低温等离子刀的治疗温度相对人组织仍属于高温，组织细胞受此温度影响后，同样会出现电刀剥离造成组织蛋白变性，尤其是持续一定时间后，亦可对组织造成热损伤。而组织细胞的变性坏死是一个逐渐发展的过程，故部分患者行低温等离子手术后，其术区肿胀、术后疼痛等反应不比高频剥离电刀反应轻。由于每次手术时间存在差异所以等离子治疗仪在离体实验研究组织热损伤报告中选用了最大手术时间，由对比可见最大手术时间的等离子治疗仪和正常使用的高频剥离电刀热损深度。故正常使用的等离子治疗仪的热损深度应低于高频剥离电刀热损深度。Preferably, the display unit 307 is used to display the operating status of the low-temperature plasma peeling knife surgery system in real time. The working principle of the low-temperature plasma stripping knife surgery system 300 is plasma low-temperature ablation. The bipolar cutter head is used to generate energy to convert physiological saline into a thin layer of plasma, which dissociates the molecular bonds that constitute the cell components in the target tissue, causing coagulation necrosis of the tissue, resulting in the effect of ablation or peeling. Because it works at a relatively low temperature, the thermal damage to surrounding tissues is minimized compared with the traditional high-frequency stripping electric knife. Working at around 35°C can reduce the volume of the target tissue, seal the microvessels in the target tissue, and resect the lesion. Its low temperature and tissue volume reduction and ablation characteristics have the advantages of shortening postoperative recovery time, reducing postoperative pain and reducing surgical treatment costs compared with commonly used monopolar electrocautery. The temperature around the knife head of the low-temperature plasma peeling knife surgery system 300 is lower than 70°C when it is working (see the report on tissue thermal damage in vitro experiments for details), which is comparable to the traditional high-frequency peeling electric knife (100-150°C high temperature). It is lower than the working temperature. Although the treatment temperature of low-temperature plasma knife is still high temperature compared with human tissue, after tissue cells are affected by this temperature, tissue protein denaturation will also occur due to electric knife stripping, especially after a certain period of time. cause heat damage. The degeneration and necrosis of tissue cells is a gradual process, so after low-temperature plasma surgery in some patients, the swelling and postoperative pain in the operative area are not as severe as those of high-frequency stripping electrosurgical surgery. Due to the difference in the operation time of each operation, the plasma therapy device selected the maximum operation time in the report of the in vitro experimental research on tissue thermal damage. The comparison shows that the plasma therapy device with the maximum operation time and the heat damage depth of the high-frequency stripping electric knife in normal use. Therefore, the heat damage depth of the normal use plasma therapy instrument should be lower than the heat damage depth of the high-frequency peeling electrosurgical knife.
图4为根据本发明优选实施方式的低温等离子剥离刀手术方法400的流程图。如图4所示，方法400 从步骤401处开始。在步骤401，接收用户输入的控制指令。FIG. 4 is a flowchart of a low temperature plasma exfoliation knife surgery method 400 according to a preferred embodiment of the present invention. As shown in FIG. 4 , method 400 starts at step 401 . In step 401, a control instruction input by a user is received.
在步骤402，对所述控制指令进行解析并且当所述控制指令指示第一模式时生成第一模式指令，根据当前阻抗和所述控制指令计算用于第一模式下的输出功率。In step 402, the control instruction is analyzed and the first mode instruction is generated when the control instruction indicates the first mode, and the output power for the first mode is calculated according to the current impedance and the control instruction.
在步骤403，确定与所述第一模式下的输出功率相关联的第一电压指示。In step 403, a first voltage indication associated with output power in said first mode is determined.
在步骤404，将所述第一模式指令和第一电压指示转发给等离子设备，以及从所述等离子设备接收目标接触端的当前阻抗。At step 404, the first mode command and the first voltage indication are forwarded to the plasma device, and the current impedance of the target contact is received from the plasma device.
在步骤405，响应于接收到第一模式指令和第一电压指示，促使所述等离子设备进入第一模式：通过导电介质在所述等离子单元的目标接触端的发射电极和回路电极之间进行电路激活以形成薄层，为发射电极和回路电极之间施加第一电压，使得所述导电介质达到第一温度并且被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化剥离；At step 405, in response to receiving a first mode command and a first voltage indication, causing the plasma device to enter a first mode: activating a circuit between an emitter electrode and a return electrode at a target contact end of the plasma cell through a conductive medium To form a thin layer, apply a first voltage between the emitter electrode and the return electrode, so that the conductive medium reaches a first temperature and is converted into a plasma layer, thereby using electrical energy to excite the conductive medium to generate plasma, and the radio frequency based on the plasma The energy vaporizes and strips the target body;
其中所述发射电极、等离子层、回路电极以及目标接触端形成回路。Wherein the emitter electrode, the plasma layer, the return electrode and the target contact end form a loop.
还包括对所述控制指令进行解析并且当所述控制指令指示第二模式时生成第二模式指令，根据当前阻抗和所述控制指令计算用于第二模式下的输出功率，以及确定与所述第二模式下的输出功率相关联的第二电压指示。将所述第二模式指令和第二电压指示转发给等离子设备。响应于从接收到第二指令和第二电压指示，所述等离子设备进入第二模式：施加第二电压以将所述等离子设备的目标接触端保持为第二温度，从而将目标体进行消融凝固。It also includes parsing the control command and generating a second mode command when the control command indicates a second mode, calculating the output power for the second mode according to the current impedance and the control command, and determining the A second voltage indication associated with the output power in the second mode. The second mode command and the second voltage indication are forwarded to the plasma device. In response to receiving a second instruction and a second voltage indication, the plasma device enters a second mode: applying a second voltage to maintain a target contact end of the plasma device at a second temperature, thereby ablation and solidification of the target body .
还包括在接收到报警信号时，通过声音提示、文字提示和/或指示灯显示进行报警；其中在检测到运行故障后生成报警信号。It also includes giving an alarm through sound prompts, text prompts and/or indicator lights when an alarm signal is received; where an alarm signal is generated after an operation failure is detected.
其中用户通过对脚踏式输入设备进行操作来生成所述控制指令，其中所述控制指令为二元组<模式，功率>。The user generates the control instruction by operating the pedal input device, wherein the control instruction is a two-tuple <mode, power>.
还包括基于导电介质输入指令向所述等离子设备输入所述导电介质，其中所述等离子设备实时测量所述导电介质的当前余量并且基于所述当前余量确定是否生成所述导电介质输入指令。方法400实时显示所述等离子设备的运行状态。It also includes inputting the conductive medium to the plasma device based on a conductive medium input instruction, wherein the plasma device measures a current remaining amount of the conductive medium in real time and determines whether to generate the conductive medium input instruction based on the current remaining amount. The method 400 displays the operating status of the plasma equipment in real time.
图5为根据本发明优选实施方式的低温等离子剥离刀手术设备的结构示意图。如图5所示，低温等离子剥离刀手术设备包括：发射电极(剥离刀头)501、回路电极(圆套)502、管鞘503、注射腔接口505、拉杆帽506、垫块507、滑块(带插座孔)508、插座Pin 509和拉杆510。优选地，发射电极(剥离刀头) 501和回路电极(圆套)502通过相同的导管导入并且在目标体形成导电回路。发射电极(剥离刀头)501，经由插座Pin 509接收所述高频发生器所产生的第一输入电压，在发射电极(剥离刀头)501和回路电极 (圆套)502之间施加第一电压，使得所述导电介质达到第一温度并且促使所述导电介质被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化剥离。管鞘503，用于提供外层包覆功能。注射腔接口505基于液体输入指令向液体输入单元输入所述液体，其中所述液体输入单元实时测量所述液体的当前余量并且将所述当前余量发送给控制单元，所述控制单元基于所述当前余量确定是否生成所述液体输入指令并且在确定生成所述液体输入指令后将所述液体输入指令发送给滴液输入单元。注射腔接口505是位于后述的发射电极导线(剥离刀头导线)外的环形腔。Fig. 5 is a schematic structural view of a low-temperature plasma exfoliation knife surgical device according to a preferred embodiment of the present invention. As shown in Figure 5, the low-temperature plasma peeling knife surgical equipment includes: transmitting electrode (stripping head) 501, return electrode (round sleeve) 502, tube sheath 503, injection cavity interface 505, pull rod cap 506, spacer 507, slider (with socket hole) 508, socket Pin 509 and pull rod 510. Preferably, the emitter electrode (stripping head) 501 and the return electrode (sleeve) 502 are introduced through the same catheter and form a conductive loop at the target. The transmitting electrode (stripping head) 501 receives the first input voltage generated by the high-frequency generator via the socket Pin 509, and applies the first voltage, so that the conductive medium reaches the first temperature and promotes the conversion of the conductive medium into a plasma layer, so that the conductive medium is excited by electric energy to generate plasma, and the target object is vaporized and stripped based on the radio frequency energy of the plasma. The tube sheath 503 is used to provide the outer covering function. The injection cavity interface 505 inputs the liquid to the liquid input unit based on the liquid input instruction, wherein the liquid input unit measures the current remaining amount of the liquid in real time and sends the current remaining amount to the control unit, and the control unit based on the The current balance determines whether to generate the liquid input command and sends the liquid input command to the drip input unit after it is determined that the liquid input command is generated. The injection cavity interface 505 is an annular cavity located outside the emitter electrode wire (stripping blade wire) described later.
拉杆510用于使操作者通过把拉杆510来提供支撑力。插座Pin 509通过高频连接线与高频发生器连接，用于接收所述高频发生器所产生的第一输入电压。插座Pin 509接收所述高频发生器所产生的第二输入电压并且将所述第二输入电压传输给发射电极，在发射电极501和回路电极502之间施加第二电压，以使得目标体保持为第二温度，从而促使目标体进行消融凝固。液体输入单元(图5中未示出)，响应于液体输入信号，向目标体处输入液体从而在发射电极和回路电极之间形成导电介质的薄层。液体输入单元通过以下模式中的一种进行液体输入：滴定模式和连续供液模式。The pull rod 510 is used for the operator to provide support by pulling the pull rod 510 . The socket Pin 509 is connected to the high-frequency generator through a high-frequency connection line, and is used for receiving the first input voltage generated by the high-frequency generator. The socket Pin 509 receives the second input voltage generated by the high-frequency generator and transmits the second input voltage to the transmitting electrode, and applies the second voltage between the transmitting electrode 501 and the return electrode 502, so that the target remains is the second temperature, so as to promote ablation and coagulation of the target body. A liquid input unit (not shown in FIG. 5 ), in response to the liquid input signal, inputs liquid to the target to form a thin layer of conductive medium between the emitter electrode and the return electrode. The liquid input unit performs liquid input through one of the following modes: titration mode and continuous liquid supply mode.
其中，发射电极(剥离刀头)501的材料是不锈钢304、回路电极(圆套)502的材料是不锈钢304、管鞘503的材料是聚四氟乙烯PTFE、注射腔接口505的材料是丙烯腈-丁二烯-苯乙烯共聚物ABS、拉杆帽 506的材料是ABS、垫块507的材料是ABS、滑块(带插座孔)的材料是ABS、插座Pin的材料是不锈钢304 以及拉杆510的材料是ABS。Among them, the material of the emitter electrode (stripping head) 501 is stainless steel 304, the material of the return electrode (round sleeve) 502 is stainless steel 304, the material of the tube sheath 503 is polytetrafluoroethylene PTFE, and the material of the injection cavity interface 505 is acrylonitrile - Butadiene-styrene copolymer ABS, the material of the rod cap 506 is ABS, the material of the spacer 507 is ABS, the material of the slider (with socket hole) is ABS, the material of the socket Pin is stainless steel 304 and the rod 510 The material is ABS.
如图5所示，发射电极2的剥离刀头可呈钩状、半圆球状、梅花状、圆柱状或球状，以适应不同的目标体形状来进行切割。回路电极502的长度可以是任意合理的数值，例如4至5毫米。其中，回路电极502 的靠近管鞘503顶部的一端与管鞘503的顶端面的距离可以是任意合理的数值，例如2至3毫米。其中，出水口511(或被称为输液口)设置管鞘503的顶端面。As shown in FIG. 5 , the stripping cutter head of the emitter electrode 2 can be in the shape of a hook, a hemisphere, a quincunx, a cylinder or a ball, so as to adapt to different target shapes for cutting. The length of the return electrode 502 may be any reasonable value, such as 4 to 5 mm. Wherein, the distance between the end of the return electrode 502 near the top of the sheath 503 and the top surface of the sheath 503 can be any reasonable value, for example, 2 to 3 millimeters. Wherein, the water outlet 511 (or called the infusion port) is provided on the top surface of the sheath 503 .
发射电极501通过滑块508可伸缩地设置。在初始状态下，发射电极501回缩致管鞘503内，以方便管鞘503的前端进入人体。当到达指定位置后，滑块508向前移动，将发射电极501推出管鞘503的顶端面。滑块508在插座孔处，并且插座Pin 509设置在插座孔内。The emitter electrode 501 is telescopically arranged via a slider 508 . In the initial state, the emitter electrode 501 is retracted into the sheath 503 to facilitate the front end of the sheath 503 to enter the human body. When the designated position is reached, the slider 508 moves forward to push the emitter electrode 501 out of the top surface of the sheath 503 . The slider 508 is at the socket hole, and the socket Pin 509 is disposed in the socket hole.
图6-8为根据本发明优选实施方式的低温等离子剥离刀手术设备的局部放大或截面示意图。图6示出了双极电极插口接头(剥离刀接头)600的局部放大示意图，其中包括：发射电极导线(剥离刀头导线) 601和回路电极导线602。低温等离子剥离刀手术设备能够用于肠胃里面的诸如早癌的病变部位的剥离、消融和凝固与止血。此外，低温等离子剥离刀手术设备还能够用于关节、脊柱、皮肤、耳鼻喉等外科手术中软组织的剥离、消融、凝固与止血。本申请的低温等离子剥离刀手术设备使用时间为24小时以内、按照接触时间分类属于暂时接触、按照接触人体性质分类属于外部接入器械(与组织/骨/牙本质)以及按照医疗器械结构特征分类属于有源医疗器械。低温等离子剥离刀手术设备的附件双极手术电极属于一次性无菌产品。6-8 are partially enlarged or cross-sectional schematic diagrams of low-temperature plasma exfoliation knife surgical equipment according to a preferred embodiment of the present invention. FIG. 6 shows a partially enlarged schematic diagram of a bipolar electrode socket joint (stripping knife joint) 600 , which includes: an emitter electrode lead (stripping knife head lead) 601 and a return electrode lead 602 . The low-temperature plasma stripping knife surgical equipment can be used for stripping, ablation, coagulation and hemostasis of lesions such as early cancer in the stomach. In addition, the low-temperature plasma stripping knife surgical equipment can also be used for the stripping, ablation, coagulation and hemostasis of soft tissues in surgical operations such as joints, spine, skin, and ENT. The low-temperature plasma peeling knife surgical equipment of this application is used within 24 hours, classified as temporary contact according to the contact time, classified as external access device (with tissue/bone/dentin) according to the nature of contact with the human body, and classified according to the structural characteristics of medical devices It is an active medical device. The accessory bipolar surgical electrode of the low-temperature plasma stripping knife surgical equipment is a disposable sterile product.
低温等离子剥离刀手术设备采用双极方案，并且其工作频率为110kHz。等离子治疗仪100通过等离子技术实现对耳鼻喉等手术中软组织的剥离、消融、凝固与止血。工作时，低温等离子剥离刀手术设备通过生理盐水作为导电液，激活发射电极和回路电极之间时形成一个薄层。当等离子治疗仪给予足够的能量 (电压)时，生理盐水就转化为一个由赋能带电粒子组成的气体层(等离子层)。即，低温等离子剥离刀手术设备利用能量激发导电介质(例如，生理盐水)产生等离子体，并且依靠等离子体的能量打断组织分子键。等离子体的能量将蛋白质等生物大分子直接裂解成O2，CO2，N2等气体，从而完成对组织的汽化剥离。当对低温等离子剥离刀手术设备的工作刀头给予低电压时，电场低于产生等离子层的域值要求并且产生组织电阻热，从而将组织进行消融凝固与止血。The low-temperature plasma peeling knife surgical equipment adopts a bipolar scheme, and its working frequency is 110kHz. The plasma therapy instrument 100 realizes stripping, ablation, coagulation and hemostasis of soft tissues in ENT and other operations through plasma technology. When working, the low-temperature plasma peeling knife surgical equipment passes physiological saline as a conductive liquid, and a thin layer is formed between the emitting electrode and the return electrode when activated. When sufficient energy (voltage) is applied to the plasma therapy device, the saline solution is converted into a layer of gas (plasma layer) composed of energized charged particles. That is, the low-temperature plasma exfoliation knife surgical equipment uses energy to excite a conductive medium (eg, physiological saline) to generate plasma, and relies on the energy of the plasma to break tissue molecular bonds. The energy of the plasma directly cracks the protein and other biomacromolecules into O2 , CO2 , N2 and other gases, thereby completing the vaporization and stripping of the tissue. When a low voltage is given to the working blade of the low-temperature plasma peeling knife surgical equipment, the electric field is lower than the threshold value requirement for generating the plasma layer and generates tissue resistance heat, thereby ablation, coagulation and hemostasis of the tissue.
图7示出了沿B-B的截面示意图，其中包括：发射电极导线(剥离刀头导线)701、回路电极导线702、通液腔704和回路电极腔705。更为详细地，图7示出了发射电极导线(剥离刀头导线)701的剖面图，其中包括绝缘层707和金属丝708。发射电极导线(剥离刀头导线)需要绝缘层，起作绝缘和隔热的作用，回路电极导线702可以不设置绝缘层。7 shows a schematic cross-sectional view along B-B, which includes: an emitter electrode lead (stripping head lead) 701 , a return electrode lead 702 , a liquid passage cavity 704 and a return electrode cavity 705 . In more detail, FIG. 7 shows a cross-sectional view of an emitter electrode wire (stripped blade wire) 701 , which includes an insulating layer 707 and a metal wire 708 . The emitter electrode wire (stripping the cutter head wire) needs an insulating layer for insulation and heat insulation, and the return electrode wire 702 may not be provided with an insulating layer.
另外，本领域的技术人员根据需要，也可以将回路电极腔705作为通液腔，在回路电极腔705作为通液腔时，回路电极导线702需设置绝缘层。In addition, those skilled in the art may also use the return electrode chamber 705 as a liquid passage chamber as needed, and when the return electrode chamber 705 is used as a liquid passage chamber, the return electrode wire 702 needs to be provided with an insulating layer.
图8示出了沿C-C的截面示意图，其中包括发射电极导线(剥离刀头导线)801和回路电极导线802。FIG. 8 shows a schematic cross-sectional view along C-C, which includes an emitter electrode lead (stripping head lead) 801 and a return electrode lead 802 .
图9为根据本发明的密封组件的剥离刀(低温等离子剥离刀)的侧视图。本发明中的剥离刀能够用于肠胃里面的诸如早癌的病变部位的剥离、消融和凝固与止血。此外，该剥离刀还能够用于关节、脊柱、皮肤、耳鼻喉等外科手术中软组织的切割、消融、凝固与止血。该剥离刀使用时间为24小时以内、按照接触时间分类属于暂时接触、按照接触人体性质分类属于外部接入器械(与组织/骨/牙本质)以及按照医疗器械结构特征分类属于有源医疗器械。剥离刀采用双极方案，并且其工作频率为105kHz。可选地，该剥离刀的工作频率可以在100-110的范围内。剥离刀通过等离子技术实现对耳鼻喉等手术中软组织的切割、消融、凝固与止血。工作时，剥离刀通过生理盐水作为导电液，激活发射电极和回路电极之间时形成一个薄层。当剥离刀给予足够的能量(电压)时，生理盐水就转化为一个由赋能带电粒子组成的气体层 (等离子层)。即，剥离刀利用能量激发导电介质(例如，生理盐水)产生等离子体，并且依靠等离子体的能量打断组织分子键。等离子体的能量将蛋白质等生物大分子直接裂解成O2，CO2，N2等气体，从而完成对组织的汽化剥离。当对剥离刀的工作刀头给予低电压时，电场低于产生等离子层的域值要求并且产生组织电阻热，从而将组织进行消融凝固与止血。9 is a side view of a stripping knife (low temperature plasma stripping knife) of a sealing assembly according to the present invention. The peeling knife in the present invention can be used for peeling, ablation, coagulation and hemostasis of lesions such as early cancer in the stomach. In addition, the peeling knife can also be used for cutting, ablation, coagulation and hemostasis of soft tissues in surgical operations such as joints, spine, skin, and ear, nose and throat. The peeling knife is used within 24 hours, is classified as temporary contact according to the contact time, is classified as an external access device (with tissue/bone/dentin) according to the nature of the contact with the human body, and is classified as an active medical device according to the structural characteristics of the medical device. The stripping knife adopts a bipolar scheme, and its operating frequency is 105kHz. Optionally, the operating frequency of the stripping knife can be in the range of 100-110. The peeling knife realizes the cutting, ablation, coagulation and hemostasis of soft tissues in ENT and other operations through plasma technology. In operation, the stripping knife passes saline as a conductive fluid, forming a thin layer between the emitter and return electrodes when activated. When sufficient energy (voltage) is applied to the peeling knife, the saline solution is converted into a layer of gas (plasma layer) composed of energized charged particles. That is, the peeling knife uses energy to excite a conductive medium (eg, physiological saline) to generate plasma, and relies on the energy of the plasma to break tissue molecular bonds. The energy of the plasma directly cracks the protein and other biomacromolecules into O2 , CO2 , N2 and other gases, thereby completing the vaporization and stripping of the tissue. When a low voltage is given to the working head of the peeling knife, the electric field is lower than the threshold value requirement for generating a plasma layer and generates tissue resistance heat, thereby ablation, coagulation and hemostasis of the tissue.
剥离刀的操作部分包括手柄1、拉杆2、插座Pin 3、滑块4、垫块5、前杆6(也称为拉杆帽)、管鞘7、注射腔接口8和推杆9、10等等。拉杆2由操作者把握方便操作该剥离刀。管鞘7是从前杆16纵向延伸的细长管，管鞘7要被插入目标体(人体的病灶)。The operating part of the peeling knife includes handle 1, pull rod 2, socket Pin 3, slider 4, spacer 5, front rod 6 (also called pull rod cap), tube sheath 7, injection cavity interface 8 and push rods 9, 10, etc. Wait. The pull bar 2 is grasped by the operator to facilitate the operation of the peeling knife. The sheath 7 is an elongated tube extending longitudinally from the front rod 16, and the sheath 7 is to be inserted into a target body (lesion of the human body).
如图12所示，前杆6内形成腔室6a，并且注射腔接口8形成在前杆6的外周上。液体进入端口8a形成在前杆6的外周上的注射腔接口8内。As shown in FIG. 12 , a chamber 6 a is formed inside the front rod 6 , and an injection cavity port 8 is formed on the outer periphery of the front rod 6 . A liquid inlet port 8 a is formed in the injection cavity port 8 on the outer periphery of the front shaft 6 .
通液腔18设置在管鞘7中，该通液腔18从形成在前杆6内的腔室6a通向管鞘7的顶端。通液腔18 围绕发射电极导线16(参见图13)。液体(例如，导电介质、清洗水等)经由液体进入端口8a通过腔室 6a进入通液腔18。A liquid passage chamber 18 is provided in the sheath 7 , and the liquid passage chamber 18 leads from the chamber 6 a formed in the front rod 6 to the top end of the sheath 7 . A liquid passage 18 surrounds the emitter electrode lead 16 (see FIG. 13 ). Liquid (for example, a conductive medium, washing water, etc.) enters the liquid passage chamber 18 through the chamber 6a via the liquid inlet port 8a.
管鞘7用于提供外层包覆功能。注射腔接口8基于来自未图示的控制器的液体输入指令输入液体(例如导电介质)，其中所述液体的当前余量被实时测量并且所述当前余量被传输至控制器，控制器基于所述当前余量确定是否生成所述液体输入指令并且在确定生成所述液体输入指令后控制从液体进入端口8a经由腔室6a至通液腔18并最终至目标体的输入。The tube sheath 7 is used to provide an outer coating function. The injection chamber interface 8 inputs liquid (such as a conductive medium) based on a liquid input instruction from a controller not shown, wherein the current surplus of the liquid is measured in real time and transmitted to the controller, and the controller based on The current remaining amount determines whether to generate the liquid input instruction and controls the input from the liquid inlet port 8a to the liquid passage chamber 18 via the chamber 6a and finally to the target body after the liquid input instruction is determined to be generated.
更进一步，如图10-12所示，剥离刀还包括密封组件。具体地，该密封组件包括密封圈11和将密封圈11固定在腔室6a的一侧的固定螺纹构件12，该腔室6a的一侧是腔室6a的与通液腔18相对的一侧。Furthermore, as shown in Figures 10-12, the peeling knife also includes a sealing assembly. Specifically, the sealing assembly includes a sealing ring 11 and a fixing screw member 12 for fixing the sealing ring 11 on one side of the chamber 6a, which is the side of the chamber 6a opposite to the liquid passage chamber 18 .
更为具体地，腔室6a的一侧的壁部形成有第一台阶孔6b，第一台阶孔6b的外侧设置有第二台阶孔 6c并且第二台阶孔6c的直径大于第一台阶孔6c的直径。密封圈11相对于该第一台阶孔6b被固定。第二台阶孔6c的内壁形成有内螺纹，固定螺纹构件12的外周形成有外螺纹。由此，固定螺纹构件12被螺纹接合在第二台阶孔6c中。此外，固定螺纹构件12为中空的大致圆柱体。More specifically, a first stepped hole 6b is formed on one side of the chamber 6a, and a second stepped hole 6c is provided outside the first stepped hole 6b, and the diameter of the second stepped hole 6c is larger than that of the first stepped hole 6c. diameter of. The sealing ring 11 is fixed relative to the first stepped hole 6b. The inner wall of the second stepped hole 6 c is formed with internal threads, and the outer periphery of the fixing screw member 12 is formed with external threads. Thereby, the fixing screw member 12 is screwed into the second stepped hole 6c. In addition, the fixing screw member 12 is a hollow substantially cylindrical body.
进一步，根据本发明的优选实施例的密封组件还包括挡块13，该挡块设置在密封圈11和固定螺纹构件12之间。挡块13包括圆形部分和从圆形部分凸出的两个凸耳13a。凸耳13a被适配在第二台阶孔6c的卡槽15内。当在凸耳13a适配在卡槽内的情况下，通过拧紧固定螺纹构件12，挡块13被固定在第二台阶孔6c中以及密封圈11被固定在第一台阶孔6b中。此外，挡块13为中空的大致圆形薄板构件。Further, the sealing assembly according to the preferred embodiment of the present invention further includes a stopper 13 disposed between the sealing ring 11 and the fixing threaded member 12 . The stopper 13 includes a circular portion and two lugs 13a protruding from the circular portion. The lug 13a is fitted in the engaging groove 15 of the second stepped hole 6c. When the lug 13a fits in the slot, the stopper 13 is fixed in the second stepped hole 6c and the sealing ring 11 is fixed in the first stepped hole 6b by tightening the fixing threaded member 12 . In addition, the stopper 13 is a hollow substantially circular thin plate member.
此外，推杆9穿透密封圈11并且通过腔室6a进入通液腔18，并且推杆9相对于密封组件可滑动。同样，推杆10穿透密封圈11并且通过腔室6a进入管鞘7内、在形成在所述管鞘7中且与所述通液腔18偏离的位置的空腔7a中。在本实施例中，推杆10相对于密封组件固定。进一步，管子14被插入空腔7a并且从密封组件(的固定管螺纹构件12)向外突出，推杆10在管子14中可滑动。即，管子14设置在空腔 7a和推杆10之间。In addition, the push rod 9 penetrates the sealing ring 11 and enters the liquid passage chamber 18 through the chamber 6a, and the push rod 9 is slidable relative to the sealing assembly. Likewise, the push rod 10 penetrates the sealing ring 11 and enters the sheath 7 through the chamber 6 a in a cavity 7 a formed in said sheath 7 at a position offset from said liquid-through chamber 18 . In this embodiment, the push rod 10 is fixed relative to the sealing assembly. Further, a pipe 14 is inserted into the cavity 7a and protrudes outward from (the fixed pipe thread member 12 of) the sealing assembly, and the push rod 10 is slidable in the pipe 14 . That is, the tube 14 is disposed between the cavity 7a and the push rod 10.
此外，如图9所示，剥离刀的操作部分还包括设置在管鞘7的顶端的发射电极21和回路电极22。发射电极21通过推杆9可伸缩地设置。In addition, as shown in FIG. 9 , the operating part of the peeling knife also includes a transmitter electrode 21 and a return electrode 22 arranged on the top end of the sheath 7 . The emitter electrode 21 is telescopically arranged through the push rod 9 .
发射电极21(剥离刀头)和回路电极22(圆套)通过管鞘7被导入目标体并且在目标体形成导电回路。发射电极21经由通过高频连接线与高频发生器(未图示)连接的插座Pin3接收所述高频发生器所产生的第一输入电压，以在发射电极21和回路电极22之间施加第一电压，使得所述导电介质达到第一温度并且促使所述导电介质被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化剥离。The emitter electrode 21 (stripping head) and return electrode 22 (circle) are introduced into the target body through the sheath 7 and form a conductive loop on the target body. The transmitting electrode 21 receives the first input voltage generated by the high-frequency generator via the socket Pin3 connected to the high-frequency generator (not shown) through a high-frequency connection line, so as to apply the voltage between the transmitting electrode 21 and the return electrode 22. The first voltage makes the conductive medium reach the first temperature and prompts the conductive medium to be converted into a plasma layer, so that the conductive medium is excited by electric energy to generate plasma, and the target is vaporized and stripped based on the radio frequency energy of the plasma.
如图9所示，发射电极21的剥离刀头可呈钩状、半圆球状、梅花状、圆柱状或球状，以适应不同的目标体形状来进行汽化剥离。As shown in FIG. 9 , the stripping cutter head of the emitter electrode 21 can be in the shape of a hook, a hemisphere, a quincunx, a cylinder or a ball, so as to adapt to different shapes of targets for vaporization stripping.
发射电极21通过滑块4可伸缩地设置。在初始状态下，发射电极21回缩致管鞘7内，以方便管鞘7 的前端进入人体。当到达指定位置后，滑块4向前移动，将发射电极21推出管鞘7的顶端面。The emitter electrode 21 is telescopically arranged via the slider 4 . In the initial state, the transmitting electrode 21 is retracted into the sheath 7 to facilitate the front end of the sheath 7 to enter the human body. After reaching the specified position, the slider 4 moves forward to push the emitter electrode 21 out of the top surface of the sheath 7 .
拉杆2用于使操作者通过把拉杆2来提供支撑力。插座Pin 3通过高频连接线与高频发生器连接，用于接收所述高频发生器所产生的第一输入电压。插座Pin 3接收所述高频发生器所产生的第二输入电压并且将所述第二输入电压传输给发射电极21，在发射电极21和回路电极22之间施加第二电压，以使得目标体保持为第二温度，从而促使目标体进行消融凝固。The pull rod 2 is used to enable the operator to provide support by pulling the pull rod 2 . The socket Pin 3 is connected to the high-frequency generator through a high-frequency connection line, and is used for receiving the first input voltage generated by the high-frequency generator. Socket Pin 3 receives the second input voltage generated by the high-frequency generator and transmits the second input voltage to the emitter electrode 21, and applies the second voltage between the emitter electrode 21 and the return electrode 22, so that the target The temperature is kept at the second temperature, so as to promote ablation and coagulation of the target body.
例如，所述第一温度的范围为35℃-40℃，所述第二温度的范围为40℃-70℃。所述第一电压的范围为100Vrms至300Vrms，并且所述第二电压的范围为60Vrms至80Vrms。For example, the first temperature ranges from 35°C to 40°C, and the second temperature ranges from 40°C to 70°C. The first voltage ranges from 100Vrms to 300Vrms, and the second voltage ranges from 60Vrms to 80Vrms.
回路电极22的长度L1可以是任意合理的数值，例如4至5毫米。其中，回路电极22的靠近管鞘7 顶部的一端与管鞘7的顶端面的距离L2可以是任意合理的数值，例如2至3毫米。其中，出水口23(或被称为输液口，见图9)设置在管鞘7的顶端，从下文描述的液体进入端口8a进入的液体从出水口23进入目标体。The length L1 of the return electrode 22 may be any reasonable value, such as 4 to 5 mm. Wherein, the distance L2 between the end of the return electrode 22 near the top of the sheath 7 and the top surface of the sheath 7 can be any reasonable value, for example, 2 to 3 mm. Wherein, a water outlet 23 (or called an infusion port, see FIG. 9 ) is arranged at the top of the sheath 7 , and the liquid entering from the liquid inlet port 8 a described below enters the target body through the water outlet 23 .
其中，例如，发射电极21的材料是不锈钢304，回路电极22的材料是不锈钢304，管鞘7的材料是聚四氟乙烯PTFE，注射腔接口8的材料是丙烯腈-丁二烯-苯乙烯共聚物ABS，前杆6的材料是ABS，垫块 5的材料是ABS，滑块4的材料是ABS，插座Pin 3的材料是不锈钢304以及手柄1的材料是ABS。Wherein, for example, the material of the emitter electrode 21 is stainless steel 304, the material of the return electrode 22 is stainless steel 304, the material of the tube sheath 7 is polytetrafluoroethylene PTFE, and the material of the injection cavity interface 8 is acrylonitrile-butadiene-styrene Copolymer ABS, the material of the front rod 6 is ABS, the material of the spacer 5 is ABS, the material of the slider 4 is ABS, the material of the socket Pin 3 is stainless steel 304 and the material of the handle 1 is ABS.
如图13所示，图示了发射电极导线(剥离刀头导线)16、回路电极导线17、通液腔18和发射电极腔 19。更为详细地，图13中的放大视图示出了发射电极导线16的剖面图，其中包括绝缘层16a和金属丝 16b。发射电极导线16需要绝缘层，起作绝缘和隔热的作用，回路电极导线17可以不设置绝缘层。As shown in FIG. 13 , an emitter electrode wire (stripping head wire) 16, a return electrode wire 17, a liquid passage chamber 18 and an emitter electrode chamber 19 are illustrated. In more detail, the enlarged view in Fig. 13 shows a cross-sectional view of the emitter electrode wire 16, which includes the insulating layer 16a and the wire 16b. The emitter electrode wire 16 needs an insulating layer for insulation and heat insulation, and the return electrode wire 17 may not be provided with an insulating layer.
发射电极导线16和回路电极导线17分别与发射电极21和回路电极22相连接。进一步，发射电极导线16和回路电极导线17分别穿过推杆9和推杆10的内部并连接至未图示的高频发生器。在如上所述滑块4被操作以向前移动从而推杆9相对于密封组件移动而推杆10相对于密封组件固定不动时，发射电极导线16和回路电极导线17分别保持在推杆9和推杆10的内部。The emitter electrode wire 16 and the return electrode wire 17 are respectively connected to the emitter electrode 21 and the return electrode 22 . Further, the emitter electrode wire 16 and the return electrode wire 17 respectively pass through the inside of the push rod 9 and the push rod 10 and are connected to a high-frequency generator not shown in the figure. When the slider 4 is operated to move forward as described above so that the push rod 9 moves relative to the seal assembly and the push rod 10 is stationary relative to the seal assembly, the emitter electrode lead 16 and the return electrode lead 17 are respectively held on the push rod 9 and the interior of the putter 10.
此外，优选地，密封圈11可以由例如三元乙丙模制而成。但是，本发明并不局限于此。例如，密封圈11可以由任何能够实现密封的材料制成，例如橡胶等等。Furthermore, preferably, the sealing ring 11 may be molded from, for example, EPDM. However, the present invention is not limited thereto. For example, the sealing ring 11 can be made of any material capable of achieving sealing, such as rubber and the like.
此外，优选地，固定螺纹构件12的一侧(外侧)设置有槽口12a。但是，本发明并不局限于此。例如，在固定螺纹件12的外侧可以设置凸耳并且通过凸耳旋转固定螺纹件12。Furthermore, preferably, one side (outer side) of the fixing screw member 12 is provided with a notch 12a. However, the present invention is not limited thereto. For example, lugs can be provided on the outside of the fixing screw 12 and the fixing screw 12 can be rotated by the lugs.
下面描述根据本发明的优选实施例实现的效果。Effects achieved according to preferred embodiments of the present invention are described below.
首先，由于在腔室6a的与通液腔18相对的一侧设置有密封组件，密封组件包括密封圈11和用于将密封圈11固定在腔室的一侧的固定螺纹构件12并且推杆9穿透密封圈11并且通过腔室6a进入通液腔18，推杆10封组件能够在推杆9和推杆10的外周进行密封。结果，在利用剥离刀进行手术期间从液体进入端口8a向腔室6a及通液腔18导入液体(例如导电介质)时，密封圈11能够防止从液体进入端口8a进入腔室6a和通液腔18中的液体由于自身的压力而在腔室6a的一侧、从两个推杆9、10的外周向外泄漏。First, since a sealing assembly is provided on the opposite side of the chamber 6a to the liquid chamber 18, the sealing assembly includes a sealing ring 11 and a fixing threaded member 12 for fixing the sealing ring 11 on one side of the chamber and the push rod 9 penetrates the sealing ring 11 and enters the liquid passage chamber 18 through the chamber 6a, and the sealing assembly of the push rod 10 can perform sealing on the outer periphery of the push rod 9 and the push rod 10. As a result, when a liquid (such as a conductive medium) is introduced from the liquid inlet port 8a to the chamber 6a and the liquid passage chamber 18 during the operation using a peeling knife, the sealing ring 11 can prevent the liquid from entering the chamber 6a and the liquid passage chamber from the liquid inlet port 8a. The liquid in 18 leaks out from the periphery of the two push rods 9, 10 on one side of the chamber 6a due to its own pressure.
进一步，由于挡块13设置在密封圈11和固定螺纹构件12之间。因此，当通过旋转固定螺纹构件12 以将密封圈11固定在腔室6a的一侧时，挡块13可以紧紧地夹在密封圈11和固定螺纹构件12之间，从而牢固地固定密封圈11，同时在例如当需要拆卸密封组件而旋转固定螺纹构件12时，防止密封圈11跟随固定螺纹构件12移动。Further, since the stopper 13 is disposed between the sealing ring 11 and the fixing screw member 12 . Therefore, when the sealing ring 11 is fixed on one side of the chamber 6a by rotating the fixing screw member 12, the stopper 13 can be tightly clamped between the sealing ring 11 and the fixing screw member 12, thereby firmly fixing the sealing ring 11. At the same time, for example, when the sealing assembly needs to be disassembled and the fixing threaded member 12 is rotated, the sealing ring 11 is prevented from moving along with the fixing threaded member 12 .
进一步，通过挡块13的凸耳13a，可以将挡块13可靠地保持在其位置而不会随着固定螺纹构件13旋转。Further, by the lug 13 a of the stopper 13 , the stopper 13 can be reliably held in its position without being rotated with the fixing screw member 13 .
进一步，由于密封圈11由三元乙丙模制而成，相比于传统的利用橡胶等制成的密封件，该密封圈11 可以具有优越的耐氧化、抗侵蚀等能力。因此，可以延长密封圈的使用寿命。Further, since the sealing ring 11 is molded from EPDM, compared with the traditional seals made of rubber, the sealing ring 11 can have superior oxidation resistance, corrosion resistance and other capabilities. Therefore, the service life of the sealing ring can be extended.
进一步，固定螺纹构件12的一侧设置有槽口。因此，利用特定工具卡入槽口，可以方便地旋拧固定螺纹构件12。Further, one side of the fixing screw member 12 is provided with a notch. Therefore, the threaded member 12 can be screwed and fixed conveniently by using a specific tool to snap into the notch.
进一步，管子14被插入空腔7a并且从密封组件向外突出，推杆10被插入管子14。因此，可以利用管子14隔离从液体进入端口8a导入腔室6a的液体和该空腔7a。换句话说，该液体仅能从液体进入端口 8a经过腔室6a进入通液腔10，而不进入该空腔7a。Further, a tube 14 is inserted into the cavity 7a and protrudes outward from the sealing assembly, and the push rod 10 is inserted into the tube 14 . Therefore, the cavity 7 a can be isolated from the liquid introduced into the chamber 6 a from the liquid inlet port 8 a by the tube 14 . In other words, the liquid can only enter the liquid passage chamber 10 from the liquid inlet port 8a through the chamber 6a, but not into the cavity 7a.
进一步，由于发射电极21的剥离刀头可呈钩状、半圆球状、梅花状、圆柱状或球状，因此，可以对不同形状的目标体进行汽化剥离。Further, since the stripping cutter head of the emitter electrode 21 can be in the shape of a hook, a hemisphere, a quincunx, a cylinder or a ball, it can vaporize and strip objects of different shapes.
虽然如上所述发射电极导线16周围形成通液腔，但是本领域的技术人员根据需要，也可以将回路电极腔19作为通液腔，在回路电极腔19作为通液腔时，回路电极导线17需设置绝缘层。Although a liquid passage cavity is formed around the emitter electrode wire 16 as described above, those skilled in the art may also use the return electrode chamber 19 as a liquid passage chamber as required. When the return electrode chamber 19 is used as a liquid passage chamber, the return electrode wire 17 An insulating layer is required.
图14为根据本发明的密封组件的剥离刀(低温等离子剥离刀)的侧视图。本发明中的剥离刀能够用于肠胃里面的诸如早癌的病变部位的剥离、消融和凝固与止血。此外，该剥离刀还能够用于关节、脊柱、皮肤、耳鼻喉等外科手术中软组织的剥离、消融、凝固与止血。该剥离刀使用时间为24小时以内、按照接触时间分类属于暂时接触、按照接触人体性质分类属于外部接入器械(与组织/骨/牙本质)以及按照医疗器械结构特征分类属于有源医疗器械。剥离刀采用双极方案，并且其工作频率为105kHz。可选地，该剥离刀的工作频率可以在100-110的范围内。剥离刀通过等离子技术实现对耳鼻喉等手术中软组织的剥离、消融、凝固与止血。工作时，剥离刀通过生理盐水作为导电液，激活发射电极和回路电极之间时形成一个薄层。当剥离刀给予足够的能量(电压)时，生理盐水就转化为一个由赋能带电粒子组成的气体层(等离子层)。即，剥离刀利用能量激发导电介质(例如，生理盐水)产生等离子体，并且依靠等离子体的能量打断组织分子键。等离子体的能量将蛋白质等生物大分子直接裂解成O2，CO2，N2等气体，从而完成对组织的汽化剥离。当对剥离刀的工作刀头给予低电压时，电场低于产生等离子层的域值要求并且产生组织电阻热，从而将组织进行消融凝固与止血。Fig. 14 is a side view of the stripping knife (low temperature plasma stripping knife) of the sealing assembly according to the present invention. The peeling knife in the present invention can be used for peeling, ablation, coagulation and hemostasis of lesions such as early cancer in the stomach. In addition, the peeling knife can also be used for the peeling, ablation, coagulation and hemostasis of soft tissues in surgical operations such as joints, spine, skin, and ear, nose and throat. The peeling knife is used within 24 hours, is classified as temporary contact according to the contact time, is classified as an external access device (with tissue/bone/dentin) according to the nature of the contact with the human body, and is classified as an active medical device according to the structural characteristics of the medical device. The stripping knife adopts a bipolar scheme, and its operating frequency is 105kHz. Optionally, the operating frequency of the stripping knife can be in the range of 100-110. The peeling knife uses plasma technology to realize the peeling, ablation, coagulation and hemostasis of soft tissues in ENT and other operations. In operation, the stripping knife passes saline as a conductive fluid, forming a thin layer between the emitter and return electrodes when activated. When sufficient energy (voltage) is applied to the peeling knife, the saline solution is converted into a layer of gas (plasma layer) composed of energized charged particles. That is, the peeling knife uses energy to excite a conductive medium (eg, physiological saline) to generate plasma, and relies on the energy of the plasma to break tissue molecular bonds. The energy of the plasma directly cracks the protein and other biological macromolecules into O2 , CO2 , N2 and other gases, thereby completing the vaporization and stripping of the tissue. When a low voltage is given to the working head of the peeling knife, the electric field is lower than the threshold value requirement for generating a plasma layer and generates tissue resistance heat, thereby ablation, coagulation and hemostasis of the tissue.
剥离刀的操作部分包括手柄1、拉杆2、插座Pin 3、滑块4、垫块5、前杆6(也称为拉杆帽)、管鞘7、注射腔接口8等等。拉杆2由操作者把握方便操作该剥离刀。管鞘7是从前杆6纵向延伸的细长管，管鞘7要被插入目标体(人体的病灶)。The operating part of the peeling knife includes a handle 1, a pull rod 2, a socket Pin 3, a slider 4, a spacer 5, a front rod 6 (also called a pull rod cap), a tube sheath 7, an injection cavity interface 8, and the like. The pull bar 2 is grasped by the operator to facilitate the operation of the peeling knife. The sheath 7 is an elongated tube extending longitudinally from the front rod 6, and the sheath 7 is to be inserted into a target body (lesion of the human body).
通液腔18设置在管鞘7中，该通液腔18从形成在前杆6内的腔室通向管鞘7的顶端。通液腔18围绕发射电极导线16(参见图18)。液体(例如，导电介质、清洗水等)经由形成在注射腔接口8内的液体进入端口通过前杆6内的腔室进入通液腔18。A liquid passage chamber 18 is provided in the sheath 7 , and the liquid passage chamber 18 leads from a chamber formed in the front rod 6 to the top end of the sheath 7 . A liquid passage 18 surrounds the emitter electrode lead 16 (see FIG. 18 ). Liquid (for example, conductive medium, washing water, etc.) enters the liquid passage chamber 18 through the chamber in the front rod 6 through the liquid inlet port formed in the injection chamber interface 8 .
管鞘7用于提供外层包覆功能。注射腔接口8基于来自未图示的控制器的液体输入指令输入液体(例如导电介质)，其中所述液体的当前余量被实时测量并且所述当前余量被传输至控制器，控制器基于所述当前余量确定是否生成所述液体输入指令并且在确定生成所述液体输入指令后控制液体从注射腔接口8内的液体进入端口8a经由前杆6内的腔室至通液腔18并最终至目标体的输入。The tube sheath 7 is used to provide an outer coating function. The injection chamber interface 8 inputs liquid (such as a conductive medium) based on a liquid input instruction from a controller not shown, wherein the current surplus of the liquid is measured in real time and transmitted to the controller, and the controller based on The current balance determines whether to generate the liquid input instruction and controls the liquid from the liquid inlet port 8a in the injection cavity interface 8 to the liquid passage chamber 18 via the chamber in the front rod 6 after determining that the liquid input instruction is generated. The final input to the target body.
此外，如图14所示，剥离刀的操作部分还包括设置在管鞘7的顶端的发射电极21和回路电极22。发射电极21形成有钩状的剥离刀头，回路电极22套在管鞘7的外周表面上。发射电极21(剥离刀头)和回路电极22(圆套)通过管鞘7被导入目标体并且在目标体形成导电回路。发射电极21经由通过高频连接线与高频发生器(未图示)连接的插座Pin 3接收所述高频发生器所产生的第一输入电压，以在发射电极 21和回路电极22之间施加第一电压，使得所述导电介质达到第一温度并且促使所述导电介质被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化剥离。In addition, as shown in FIG. 14 , the operating part of the peeling knife also includes a transmitter electrode 21 and a return electrode 22 arranged on the top end of the sheath 7 . The emitter electrode 21 is formed with a hook-shaped stripping cutter head, and the return electrode 22 is sleeved on the outer peripheral surface of the sheath 7 . The emitter electrode 21 (stripping head) and return electrode 22 (circle) are introduced into the target body through the sheath 7 and form a conductive loop on the target body. The transmitting electrode 21 receives the first input voltage generated by the high-frequency generator through the socket Pin 3 connected to the high-frequency generator (not shown) through a high-frequency connecting line, so as to connect between the transmitting electrode 21 and the return electrode 22 Applying a first voltage makes the conductive medium reach a first temperature and prompts the conductive medium to be converted into a plasma layer, so that the conductive medium is excited by electric energy to generate plasma, and the target is vaporized and stripped based on the radio frequency energy of the plasma.
进一步，发射电极21通过滑块4可伸缩地设置。在初始状态下，发射电极21缩回管鞘7内，以方便管鞘7的前端进入人体。当到达指定位置后，滑块4向前移动，将发射电极21推出管鞘7的顶端面。Further, the emitter electrode 21 is telescopically arranged through the slider 4 . In the initial state, the transmitting electrode 21 is retracted into the sheath 7 to facilitate the front end of the sheath 7 to enter the human body. After reaching the specified position, the slider 4 moves forward to push the emitter electrode 21 out of the top surface of the sheath 7 .
拉杆2用于使操作者通过把拉杆2来提供支撑力。插座Pin 3通过高频连接线与高频发生器连接，用于接收所述高频发生器所产生的第一输入电压。插座Pin 3接收所述高频发生器所产生的第二输入电压并且将所述第二输入电压传输给发射电极21，在发射电极21和回路电极22之间施加第二电压，以使得目标体保持为第二温度，从而促使目标体进行消融凝固。The pull rod 2 is used to enable the operator to provide support by pulling the pull rod 2 . The socket Pin 3 is connected to the high-frequency generator through a high-frequency connection line, and is used for receiving the first input voltage generated by the high-frequency generator. Socket Pin 3 receives the second input voltage generated by the high-frequency generator and transmits the second input voltage to the emitter electrode 21, and applies the second voltage between the emitter electrode 21 and the return electrode 22, so that the target The temperature is kept at the second temperature, so as to promote ablation and coagulation of the target body.
例如，所述第一温度的范围为35℃-40℃，所述第二温度的范围为40℃-70℃。所述第一电压的范围为100Vrms至300Vrms，并且所述第二电压的范围为60Vrms至80Vrms。For example, the first temperature ranges from 35°C to 40°C, and the second temperature ranges from 40°C to 70°C. The first voltage ranges from 100Vrms to 300Vrms, and the second voltage ranges from 60Vrms to 80Vrms.
回路电极22的长度L1可以是任意合理的数值，例如4至5毫米。其中，回路电极22的靠近管鞘7 顶部的一端与管鞘7的顶端面的距离L2可以是任意合理的数值，例如2至3毫米。其中，出水口(或被称为输液口)设置在管鞘7的顶端，从形成在注射腔接口8内的液体进入端口进入的液体从出水口进入目标体。The length L1 of the return electrode 22 may be any reasonable value, such as 4 to 5 mm. Wherein, the distance L2 between the end of the return electrode 22 near the top of the sheath 7 and the top surface of the sheath 7 can be any reasonable value, for example, 2 to 3 mm. Wherein, the water outlet (or called infusion port) is arranged at the top of the sheath 7, and the liquid entering from the liquid inlet port formed in the injection cavity interface 8 enters the target body through the water outlet.
其中，例如，发射电极21的材料是不锈钢304，回路电极22的材料是不锈钢304，管鞘7的材料是聚四氟乙烯PTFE，注射腔接口8的材料是丙烯腈-丁二烯-苯乙烯共聚物ABS，前杆6的材料是ABS，垫块 5的材料是ABS，滑块4的材料是ABS，插座Pin 3的材料是不锈钢304以及手柄1的材料是ABS。Wherein, for example, the material of the emitter electrode 21 is stainless steel 304, the material of the return electrode 22 is stainless steel 304, the material of the tube sheath 7 is polytetrafluoroethylene PTFE, and the material of the injection cavity interface 8 is acrylonitrile-butadiene-styrene Copolymer ABS, the material of the front rod 6 is ABS, the material of the spacer 5 is ABS, the material of the slider 4 is ABS, the material of the socket Pin 3 is stainless steel 304 and the material of the handle 1 is ABS.
如图15所示，图示了发射电极导线(剥离刀头导线)16、回路电极导线17、通液腔18和回路电极腔 19。更为详细地，图18中的放大视图示出了发射电极导线16的剖面图，其中包括绝缘层16a和金属丝 16b。发射电极导线16需要绝缘层，起作绝缘和隔热的作用，回路电极导线17可以不设置绝缘层。As shown in FIG. 15 , an emitter electrode wire (stripping head wire) 16, a return electrode wire 17, a liquid passage chamber 18 and a return electrode chamber 19 are illustrated. In more detail, the enlarged view in Fig. 18 shows a cross-sectional view of the emitter electrode wire 16, which includes the insulating layer 16a and the wire 16b. The emitter electrode wire 16 needs an insulating layer for insulation and heat insulation, and the return electrode wire 17 may not be provided with an insulating layer.
进一步，如图16所示，剥离刀还包括方形套管24和电极座25。发射电极21通过电极座25被安装在管鞘7的顶端。更具体地，如图17所示，电极座25由例如陶瓷制成，并且形成有分别位于两端部的圆孔 25a和方孔25b。在本实施例中，圆孔25a的直径小于方孔25b的边长。方形套管24的截面的尺寸和形状与方孔25b的截面的尺寸和形状基本一致，方形套管24的长度长于方孔25b的长度，并且方形套管24能够插入该方孔25b中并且在方孔25b中可滑动。在本实施例中，方形套管24和电极座25的方孔25b构成本发明的防旋转装置。Further, as shown in FIG. 16 , the peeling knife also includes a square sleeve 24 and an electrode holder 25 . The emitter electrode 21 is installed on the top end of the sheath 7 through the electrode holder 25 . More specifically, as shown in Fig. 17, the electrode holder 25 is made of, for example, ceramics, and is formed with round holes 25a and square holes 25b at both ends, respectively. In this embodiment, the diameter of the circular hole 25a is smaller than the side length of the square hole 25b. The size and shape of the cross section of the square sleeve 24 are substantially consistent with the size and shape of the cross section of the square hole 25b, the length of the square sleeve 24 is longer than the length of the square hole 25b, and the square sleeve 24 can be inserted in the square hole 25b and Can slide in the square hole 25b. In this embodiment, the square sleeve 24 and the square hole 25b of the electrode seat 25 constitute the anti-rotation device of the present invention.
电极座25与管鞘7的通液腔18过盈配合。具体地，在管鞘7被加热而膨胀的情况下，由陶瓷制成的电极座25被塞入管鞘7的通液腔18中。在管鞘7冷却之后，电极座25被牢牢地嵌入管鞘7的通液腔18 中。利用上述构造，电极座25能够被可靠地固定在通液腔18中，而不容易脱离通液腔18。结果，安装至电极座25的发射电极21以及方形套管24可以可靠地保持其位置。The electrode holder 25 is in interference fit with the liquid passage cavity 18 of the tube sheath 7 . Specifically, when the sheath 7 is heated and expanded, the electrode seat 25 made of ceramics is inserted into the liquid passage cavity 18 of the sheath 7 . After the sheath 7 cools down, the electrode seat 25 is firmly inserted into the liquid passage cavity 18 of the sheath 7 . With the above configuration, the electrode holder 25 can be reliably fixed in the liquid passage cavity 18 without being easily detached from the liquid passage chamber 18 . As a result, the emitter electrode 21 mounted to the electrode holder 25 and the square sleeve 24 can reliably maintain their positions.
此外，方形套管24由例如不锈钢制成并且套接在发射电极21上，并且通过焊接，发射电极21和方形套管24被固定在一起。进一步，固定在一起的方形套管24和发射电极21被插入方孔25b中，并且能够在方孔25b中滑动。发射电极21的钩状部分通过电极座25的圆孔25a从管鞘7的顶端突出。Furthermore, the square sleeve 24 is made of, for example, stainless steel and is sleeved on the emitter electrode 21 , and by welding, the emitter electrode 21 and the square sleeve 24 are fixed together. Further, the square sleeve 24 and the emitter electrode 21 fixed together are inserted into the square hole 25b, and can slide in the square hole 25b. The hooked portion of the emitter electrode 21 protrudes from the top end of the sheath 7 through the round hole 25 a of the electrode holder 25 .
由于与发射电极21固定在一起的方形套管24插入方孔25b，当滑块4移动从而将发射电极21从管鞘 7推出时，发射电极21不会转动，而是以例如图17所示的剥离刀头的钩子定向而从电极座25中伸出，另一方面，当滑块4移动从而将发射电极21缩回管鞘7(电极座25)中时，发射电极21也不会转动，从而以例如图17所示的剥离刀头的钩子定向而缩回电极座25中。Since the square sleeve 24 fixed together with the emitter electrode 21 is inserted into the square hole 25b, when the slider 4 moves to push the emitter electrode 21 out of the sheath 7, the emitter electrode 21 will not rotate, but as shown in Figure 17, for example The hook of the stripping cutter head is oriented to protrude from the electrode holder 25. On the other hand, when the slider 4 moves so that the emitter electrode 21 is retracted in the tube sheath 7 (electrode holder 25), the emitter electrode 21 will not rotate. , thereby retracting into the electrode holder 25 with the hook orientation of the exfoliation head such as shown in FIG. 17 .
在现有技术中，由于未设置如上所述的方形套管和方孔，因此当发射电极缩回时，发射电极可能转动而导致剥离刀头的钩子定向变成与如图17所示的钩子定向呈大约180度的角度，这样可能导致发射电极缩回时剥离刀头的钩子在从纵向方向上观察时从管鞘7的外周表面突出。结果，在例如完成汽化剥离之后需要将剥离刀退出人体时，该突出的部分可能刮伤人体或者妨碍剥离刀退出人体。In the prior art, since the above-mentioned square sleeve and square hole are not provided, when the emitter electrode is retracted, the emitter electrode may rotate and cause the hook orientation of the peeling tool head to become the same as that shown in Figure 17. The orientation is at an angle of approximately 180 degrees, which may cause the hooks of the stripping head to protrude from the outer peripheral surface of the sheath 7 when viewed in the longitudinal direction when the emitter electrode is retracted. As a result, the protruding portion may scratch the human body or prevent the exfoliation knife from withdrawing from the human body, for example, when the exfoliation knife needs to be withdrawn from the human body after the vaporization exfoliation is completed.
然而，利用上述构造的本发明，剥离刀包括用于防止发射电极21旋转的防旋转装置，即方形套管24 和方孔25b。因此，当通过滑块移动，经由发射电极导线16带动发射电极21缩回管鞘7时，由于固定在一起的方形套管24与发射电极21插入方孔25b中，因此方形套管24与发射电极21仅能沿着方孔25b滑动，而不旋转。因此，发射电极21的剥离刀头的钩子不会从管鞘7的外周表面突出。结果，能够避免刮伤人体或者阻碍剥离刀退出人体。However, with the present invention constructed as described above, the peeling blade includes anti-rotation means for preventing the emitter electrode 21 from rotating, that is, the square sleeve 24 and the square hole 25b. Therefore, when the slider moves to drive the emitter electrode 21 to retract the sheath 7 via the emitter electrode wire 16, since the fixed square sleeve 24 and the emitter electrode 21 are inserted into the square hole 25b, the square sleeve 24 and the emitter The electrode 21 can only slide along the square hole 25b without rotating. Therefore, the hook of the stripping blade of the emitter electrode 21 does not protrude from the outer peripheral surface of the sheath 7 . As a result, it is possible to avoid scratching the human body or preventing the peeling knife from withdrawing from the human body.
此外，方形套管24在方孔25b中滑动但不转动。当滑块4移动以推出发射电极21时，当方形套管24 的端面(图18中的左端面)抵接方孔25b的底壁25c时，发射电极21和方形套管24的移动被停止。结果，发射电极21从管鞘7的顶端突出的突出长度被限制。因此，可以限定该突出长度使其适合于进行汽化剥离，而不会过长或者过短。In addition, the square sleeve 24 slides but does not rotate in the square hole 25b. When the slider 4 moves to push out the emitter electrode 21, when the end face (the left end face in FIG. 18 ) of the square sleeve 24 abuts against the bottom wall 25c of the square hole 25b, the movement of the emitter electrode 21 and the square sleeve 24 is stopped. . As a result, the protruding length of the emitter electrode 21 from the tip of the sheath 7 is limited. Therefore, the protruding length can be limited so that it is suitable for vaporization stripping without being too long or too short.
在上述实施例中，电极座由陶瓷制成。在电极座25插入管鞘7中以与通液腔18过盈配合时，电极座 25不会产生变形。然而，本发明并不局限于此，电极座可以由其他较硬的绝缘材料制成。In the above embodiments, the electrode holder is made of ceramics. When the electrode seat 25 is inserted into the sheath 7 to interfere with the liquid cavity 18, the electrode seat 25 will not be deformed. However, the present invention is not limited thereto, and the electrode seat can be made of other relatively hard insulating materials.
图19为根据本发明的密封组件的剥离刀(低温等离子剥离刀)的侧视图。本发明中的剥离刀能够用于肠胃里面的诸如早癌的病变部位的剥离、消融和凝固与止血。此外，该剥离刀还能够用于关节、脊柱、皮肤、耳鼻喉等外科手术中软组织的剥离、消融、凝固与止血。该剥离刀使用时间为24小时以内、按照接触时间分类属于暂时接触、按照接触人体性质分类属于外部接入器械(与组织/骨/牙本质)以及按照医疗器械结构特征分类属于有源医疗器械。剥离刀采用双极方案，并且其工作频率为105kHz。可选地，该剥离刀的工作频率可以在100-110的范围内。剥离刀通过等离子技术实现对耳鼻喉等手术中软组织的剥离、消融、凝固与止血。工作时，剥离刀通过生理盐水作为导电液，激活发射电极和回路电极之间时形成一个薄层。当剥离刀给予足够的能量(电压)时，生理盐水就转化为一个由赋能带电粒子组成的气体层(等离子层)。即，剥离刀利用能量激发导电介质(例如，生理盐水)产生等离子体，并且依靠等离子体的能量打断组织分子键。等离子体的能量将蛋白质等生物大分子直接裂解成O2，CO2，N2等气体，从而完成对组织的汽化剥离。当对剥离刀的工作刀头给予低电压时，电场低于产生等离子层的域值要求并且产生组织电阻热，从而将组织进行消融凝固与止血。19 is a side view of a stripping knife (low temperature plasma stripping knife) of a sealing assembly according to the present invention. The peeling knife in the present invention can be used for peeling, ablation, coagulation and hemostasis of lesions such as early cancer in the stomach. In addition, the peeling knife can also be used for the peeling, ablation, coagulation and hemostasis of soft tissues in surgical operations such as joints, spine, skin, and ear, nose and throat. The peeling knife is used within 24 hours, is classified as temporary contact according to the contact time, is classified as an external access device (with tissue/bone/dentin) according to the nature of the contact with the human body, and is classified as an active medical device according to the structural characteristics of the medical device. The stripping knife adopts a bipolar scheme, and its operating frequency is 105kHz. Optionally, the operating frequency of the stripping knife can be in the range of 100-110. The peeling knife uses plasma technology to realize the peeling, ablation, coagulation and hemostasis of soft tissues in ENT and other operations. In operation, the stripping knife passes saline as a conductive fluid, forming a thin layer between the emitter and return electrodes when activated. When sufficient energy (voltage) is applied to the peeling knife, the saline solution is converted into a layer of gas (plasma layer) composed of energized charged particles. That is, the peeling knife uses energy to excite a conductive medium (eg, physiological saline) to generate plasma, and relies on the energy of the plasma to break tissue molecular bonds. The energy of the plasma directly cracks the protein and other biomacromolecules into O2 , CO2 , N2 and other gases, thereby completing the vaporization and stripping of the tissue. When a low voltage is given to the working head of the peeling knife, the electric field is lower than the threshold value requirement for generating a plasma layer and generates tissue resistance heat, thereby ablation, coagulation and hemostasis of the tissue.
剥离刀的操作部分包括手柄1、拉杆2、插座Pin 3、滑块4、垫块5、前杆6(也称为拉杆帽)、管鞘7、注射腔接口8、推杆9(第一推杆)和推杆10(第二推杆)等等。拉杆2由操作者把握方便操作该剥离刀。管鞘7是从前杆16纵向延伸的细长管，管鞘7要被插入目标体(人体的病灶)。The operating part of the peeling knife includes a handle 1, a pull rod 2, a socket Pin 3, a slider 4, a spacer 5, a front rod 6 (also called a pull rod cap), a tube sheath 7, an injection cavity interface 8, and a push rod 9 (first putter) and putter 10 (second putter) and so on. The pull bar 2 is grasped by the operator to facilitate the operation of the peeling knife. The sheath 7 is an elongated tube extending longitudinally from the front rod 16, and the sheath 7 is to be inserted into a target body (lesion of the human body).
如图20和4所示，通液腔18设置在管鞘7中，该通液腔18从形成在前杆6内的腔室通向管鞘7的顶端。通液腔18围绕发射电极导线16(参见图22)。液体(例如，导电介质、清洗水等)经由注射腔接口8中的液体进入端口8a通过前杆6内的腔室进入通液腔18。As shown in FIGS. 20 and 4 , a liquid passage chamber 18 is provided in the sheath 7 , and the liquid passage chamber 18 leads from a chamber formed in the front rod 6 to the top end of the sheath 7 . The liquid passage 18 surrounds the emitter electrode lead 16 (see FIG. 22 ). Liquid (for example, conductive medium, cleaning water, etc.) enters the liquid passage chamber 18 through the chamber in the front rod 6 through the liquid inlet port 8 a in the injection chamber interface 8 .
管鞘7用于提供外层包覆功能。注射腔接口8基于来自未图示的控制器的液体输入指令输入液体(例如导电介质)，其中所述液体的当前余量被实时测量并且所述当前余量被传输至控制器，控制器基于所述当前余量确定是否生成所述液体输入指令并且在确定生成所述液体输入指令后控制液体从注射腔接口8中的液体进入端口8a经由前杆6内的腔室至通液腔18并最终至目标体的输入。The tube sheath 7 is used to provide an outer coating function. The injection chamber interface 8 inputs liquid (such as a conductive medium) based on a liquid input instruction from a controller not shown, wherein the current surplus of the liquid is measured in real time and transmitted to the controller, and the controller based on The current balance determines whether to generate the liquid input instruction and controls the liquid from the liquid inlet port 8a in the injection cavity interface 8 to the liquid passage chamber 18 via the chamber in the front rod 6 after determining that the liquid input instruction is generated. The final input to the target body.
此外，如图19所示，剥离刀的操作部分还包括设置在管鞘7的顶端的发射电极21和回路电极22。发射电极21通过推杆9可伸缩地设置。如图19所示，发射电极21的剥离刀头可呈钩状。但是本发明并不局限于此，剥离刀头还可以呈半圆球状、梅花状、圆柱状或球状，以适应不同的目标体形状来进行汽化剥离。In addition, as shown in FIG. 19 , the operating part of the peeling knife also includes a transmitter electrode 21 and a return electrode 22 arranged on the top end of the sheath 7 . The emitter electrode 21 is telescopically arranged through the push rod 9 . As shown in FIG. 19 , the stripping blade of the emitter electrode 21 may be in the shape of a hook. But the present invention is not limited thereto, and the peeling cutter head can also be in the shape of a hemisphere, a quincunx, a cylinder or a ball, so as to adapt to different shapes of objects for vaporization peeling.
发射电极21(剥离刀头)和回路电极22(圆套)通过管鞘7被导入目标体并且在目标体形成导电回路。发射电极21经由通过高频连接线与高频发生器(未图示)连接的插座Pin3接收所述高频发生器所产生的第一输入电压，以在发射电极21和回路电极22之间施加第一电压，使得所述导电介质达到第一温度并且促使所述导电介质被转换为等离子层，从而利用电能激发导电介质产生等离子体，并且基于等离子体的射频能量对目标体进行汽化剥离。The emitter electrode 21 (stripping head) and return electrode 22 (circle) are introduced into the target body through the sheath 7 and form a conductive loop on the target body. The transmitting electrode 21 receives the first input voltage generated by the high-frequency generator via the socket Pin3 connected to the high-frequency generator (not shown) through a high-frequency connection line, so as to apply the voltage between the transmitting electrode 21 and the return electrode 22. The first voltage makes the conductive medium reach the first temperature and prompts the conductive medium to be converted into a plasma layer, so that the conductive medium is excited by electric energy to generate plasma, and the target is vaporized and stripped based on the radio frequency energy of the plasma.
发射电极21通过滑块4可伸缩地设置。在初始状态下，发射电极21回缩致管鞘7内，以方便管鞘7 的前端进入人体。当到达指定位置后，滑块4向前移动，将发射电极21推出管鞘7的顶端面。The emitter electrode 21 is telescopically arranged via the slider 4 . In the initial state, the transmitting electrode 21 is retracted into the sheath 7 to facilitate the front end of the sheath 7 to enter the human body. After reaching the specified position, the slider 4 moves forward to push the emitter electrode 21 out of the top surface of the sheath 7 .
拉杆2用于使操作者通过把拉杆2来提供支撑力。插座Pin 3通过高频连接线与高频发生器连接，用于接收所述高频发生器所产生的第一输入电压。插座Pin 3接收所述高频发生器所产生的第二输入电压并且将所述第二输入电压传输给发射电极21，在发射电极21和回路电极22之间施加第二电压，以使得目标体保持为第二温度，从而促使目标体进行消融凝固。The pull rod 2 is used to enable the operator to provide support by pulling the pull rod 2 . The socket Pin 3 is connected to the high-frequency generator through a high-frequency connection line, and is used for receiving the first input voltage generated by the high-frequency generator. Socket Pin 3 receives the second input voltage generated by the high-frequency generator and transmits the second input voltage to the emitter electrode 21, and applies the second voltage between the emitter electrode 21 and the return electrode 22, so that the target The temperature is kept at the second temperature, so as to promote ablation and coagulation of the target body.
例如，所述第一温度的范围为35℃-40℃，所述第二温度的范围为40℃-70℃。所述第一电压的范围为100Vrms至300Vrms，并且所述第二电压的范围为60Vrms至80Vrms。For example, the first temperature ranges from 35°C to 40°C, and the second temperature ranges from 40°C to 70°C. The first voltage ranges from 100Vrms to 300Vrms, and the second voltage ranges from 60Vrms to 80Vrms.
回路电极22的长度L1可以是任意合理的数值，例如4至5毫米。其中，回路电极22的靠近管鞘7 顶部的一端与管鞘7的顶端面的距离L2可以是任意合理的数值，例如2至3毫米。其中，出水口23(或被称为输液口，见图19)设置在管鞘7的顶端，从下文描述的液体进入端口8a进入的液体从出水口23进入目标体。The length L1 of the return electrode 22 may be any reasonable value, such as 4 to 5 mm. Wherein, the distance L2 between the end of the return electrode 22 near the top of the sheath 7 and the top surface of the sheath 7 can be any reasonable value, for example, 2 to 3 mm. Wherein, the water outlet 23 (or called infusion port, see FIG. 19 ) is arranged on the top of the sheath 7 , and the liquid entering from the liquid inlet port 8 a described below enters the target body through the water outlet 23 .
其中，例如，发射电极21的材料是不锈钢304，回路电极22的材料是不锈钢304，管鞘7的材料是聚四氟乙烯PTFE，注射腔接口8的材料是丙烯腈-丁二烯-苯乙烯共聚物ABS，前杆6的材料是ABS，垫块 5的材料是ABS，滑块4的材料是ABS，插座Pin 3的材料是不锈钢304以及手柄1的材料是ABS。Wherein, for example, the material of the emitter electrode 21 is stainless steel 304, the material of the return electrode 22 is stainless steel 304, the material of the tube sheath 7 is polytetrafluoroethylene PTFE, and the material of the injection cavity interface 8 is acrylonitrile-butadiene-styrene Copolymer ABS, the material of the front rod 6 is ABS, the material of the spacer 5 is ABS, the material of the slider 4 is ABS, the material of the socket Pin 3 is stainless steel 304 and the material of the handle 1 is ABS.
如图22所示，图示了发射电极导线(剥离刀头导线)16、回路电极导线17、通液腔18和回路电极腔 19。更为详细地，图22中的放大视图示出了发射电极导线16的剖面图，其中包括绝缘层16a和金属丝 16b。发射电极导线16需要绝缘层，起作绝缘和隔热的作用，回路电极导线17可以不设置绝缘层。As shown in FIG. 22 , an emitter electrode wire (stripping head wire) 16, a return electrode wire 17, a liquid passage chamber 18 and a return electrode chamber 19 are illustrated. In more detail, the enlarged view in Fig. 22 shows a cross-sectional view of the emitter electrode wire 16, which includes the insulating layer 16a and the wire 16b. The emitter electrode wire 16 needs an insulating layer for insulation and heat insulation, and the return electrode wire 17 may not be provided with an insulating layer.
顺便提及，回路电极腔19和通液腔18相互平行地形成在管鞘7中并且贯穿管鞘7。推杆9和推杆10 分别插入通液腔18和回路电极腔19中，并且发射电极21和回路电极22分别通过贯穿推杆9和推杆10 的发射电极导线16和回路电极导线17连接至高频发生器(未图示)。Incidentally, return electrode chamber 19 and liquid passage chamber 18 are formed in parallel to each other in sheath 7 and penetrate through sheath 7 . The push rod 9 and the push rod 10 are respectively inserted into the liquid passage chamber 18 and the return electrode chamber 19, and the emitter electrode 21 and the return electrode 22 are respectively connected to the High frequency generator (not shown).
如图20所示，回路电极导线17的位于第二推杆10中的一部分形成为螺旋形状。该一部分17a的直径稍小于第二推杆10的直径。As shown in FIG. 20 , a part of the return electrode wire 17 located in the second push rod 10 is formed in a spiral shape. The diameter of this part 17a is slightly smaller than the diameter of the second push rod 10 .
利用上述构造，当第二推杆10被推动时，回路电极导线17的螺旋形状的一部分17a允许回路电极导线17和第二推杆10之间的相互滑动，并且通过螺旋形状的一部分17a和第二推杆10的内表面之间的接触，使回路电极导线17和第二推杆10之间的回路电流导通。此外，由于回路电极导线17与第二推杆10 的内表面接触，因此回路电极导线17在该第二推杆10中不会径向移动。此外，由于该一部分17a位于第二推杆10内，因此即使第二推杆10被推动，也能保证该一部分17a始终位于管鞘7(PTFE管)中，而不会被推出。With the above configuration, when the second push rod 10 is pushed, the helical part 17a of the return electrode lead wire 17 allows mutual sliding between the return electrode lead 17 and the second push rod 10, and passes through the helical part 17a and the second push rod 10. The contact between the inner surfaces of the two push rods 10 makes the loop current between the loop electrode wire 17 and the second push rod 10 conduct. In addition, since the return electrode lead 17 is in contact with the inner surface of the second push rod 10 , the return electrode lead 17 does not move radially in the second push rod 10 . In addition, since the part 17a is located in the second push rod 10, even if the second push rod 10 is pushed, it can be guaranteed that the part 17a is always located in the tube sheath 7 (PTFE tube) and will not be pushed out.
已经通过参考少量实施方式描述了本发明。然而，本领域技术人员所公知的，正如附带的专利权利要求所限定的，除了本发明以上公开的其他的实施例等同地落在本发明的范围内。The invention has been described with reference to a small number of embodiments. However, it is clear to a person skilled in the art that other embodiments than the invention disclosed above are equally within the scope of the invention, as defined by the appended patent claims.
通常地，在权利要求中使用的所有术语都根据他们在技术领域的通常含义被解释，除非在其中被另外明确地定义。所有的参考“一个/所述/该[装置、组件等]”都被开放地解释为所述装置、组件等中的至少一个实例，除非另外明确地说明。这里公开的任何方法的步骤都没必要以公开的准确的顺序运行，除非明确地说明。Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise therein. All references to "a/the/the [means, component, etc.]" are openly construed to mean at least one instance of said means, component, etc., unless expressly stated otherwise. The steps of any method disclosed herein do not have to be performed in the exact order disclosed, unless explicitly stated.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811261998.5ACN110115624A (en) | 2018-10-27 | 2018-10-27 | A kind of low-temperature plasma hoe scaler surgical apparatus |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811261998.5ACN110115624A (en) | 2018-10-27 | 2018-10-27 | A kind of low-temperature plasma hoe scaler surgical apparatus |
| Publication Number | Publication Date |
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| CN110115624Atrue CN110115624A (en) | 2019-08-13 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811261998.5APendingCN110115624A (en) | 2018-10-27 | 2018-10-27 | A kind of low-temperature plasma hoe scaler surgical apparatus |
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| CN (1) | CN110115624A (en) |
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112168339A (en)* | 2020-11-03 | 2021-01-05 | 北京杰西慧中科技有限公司 | Surgical electrode and system |
| WO2021208934A1 (en)* | 2020-04-14 | 2021-10-21 | 珠海市司迈科技有限公司 | Radio frequency ablation electrode for minimally invasive surgery of otitis media and use method therefor |
| CN113827337A (en)* | 2021-10-27 | 2021-12-24 | 南昌嘉研科技有限公司 | Plasma scalpel and plasma surgical system thereof |
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107736934A (en)* | 2017-10-27 | 2018-02-27 | 上海诺英医疗器械有限公司 | A kind of low-temperature plasma hoe scaler surgical apparatus |
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107736934A (en)* | 2017-10-27 | 2018-02-27 | 上海诺英医疗器械有限公司 | A kind of low-temperature plasma hoe scaler surgical apparatus |
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| WO2021208934A1 (en)* | 2020-04-14 | 2021-10-21 | 珠海市司迈科技有限公司 | Radio frequency ablation electrode for minimally invasive surgery of otitis media and use method therefor |
| CN112168339A (en)* | 2020-11-03 | 2021-01-05 | 北京杰西慧中科技有限公司 | Surgical electrode and system |
| CN113827337A (en)* | 2021-10-27 | 2021-12-24 | 南昌嘉研科技有限公司 | Plasma scalpel and plasma surgical system thereof |
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