技术领域technical field
本发明涉及一种医疗器械，具体是一种用来治疗高血压病、通过介入的方式进入肾动脉内阻断肾脏交感神经的射频消融导管系统。The invention relates to a medical device, in particular to a radiofrequency ablation catheter system for treating hypertension and entering the renal artery to block the renal sympathetic nerve.
背景技术Background technique
高血压是临床常见病、多发病，根据最新的数据推算，中国高血压患者群已超过2亿，且呈发病人数逐年增加，发病年龄逐渐提前趋势。高血压导致的心、脑、肾等重要脏器并发症，有很高的致死率与致残率，严重危害着人类健康。我国约有3000～4000万顽固性高血压患者，而未来伴随着人口老龄化及肥胖症、糖尿病人的增加,顽固性高血压的患者数量将进一步增加，给社会、家庭、个人带来极大的负担。目前无较好的顽固性高血压治疗方法，开拓新的非药物治疗手段，弥补当前药物疗法的不足从而简单、安全、有效地控制血压刻不容缓。Hypertension is a common clinical disease and frequently-occurring disease. According to the latest data, the number of hypertensive patients in China has exceeded 200 million, and the number of patients is increasing year by year, and the age of onset is gradually advancing. Heart, brain, kidney and other important organ complications caused by high blood pressure have a high mortality rate and disability rate, which seriously endanger human health. There are about 30 to 40 million patients with refractory hypertension in my country. In the future, with the aging of the population and the increase in obesity and diabetes, the number of patients with refractory hypertension will further increase, which will bring great benefits to society, families and individuals. burden. At present, there is no better treatment method for refractory hypertension. It is urgent to develop new non-drug treatment methods to make up for the deficiency of current drug therapy so as to control blood pressure simply, safely and effectively.
大量研究证实，过度激活的交感神经系统与高血压的形成与进展密切相关,其中，肾脏交感神经系统特别是最靠近肾动脉壁的肾交感传出和传入神经，被认为是高血压始动及维持的重要因素。针对这一机制，国外学者提出了通过导管消融肾动脉交感神经治疗顽固性高血压这一新的高血压治疗策略。A large number of studies have confirmed that the overactivation of the sympathetic nervous system is closely related to the formation and progression of hypertension. Among them, the renal sympathetic nervous system, especially the renal sympathetic efferent and afferent nerves closest to the renal artery wall, is considered to be the trigger of hypertension initiation. and maintenance factors. In response to this mechanism, foreign scholars have proposed a new strategy for the treatment of hypertension through catheter ablation of renal artery sympathetic nerves for refractory hypertension.
2009年，Krum等在导管消融肾脏交感神经治疗顽固性高血压研究(Symplicity HTN-1)中首先用Ardian公司生产Symplicity消融导管对45例顽固性高血压患者实施肾脏去交感神经射频消融术，证实这项新技术的简单、安全，降压效果出现早，并能长期保持。在长达2年的追踪观察中，未发现下降的血压重新增高，且肾功保持稳定。国外多个中心正在进行或已完成经皮导管肾脏去交感神经治疗的临床研究多达十余项，已完成或正在进行的临床试验结果令人鼓舞，该项技术可望成为高血压治疗领域革命性的突破。In 2009, Krum et al first performed renal sympathetic nerve radiofrequency ablation on 45 patients with refractory hypertension using the Symplicity ablation catheter produced by Ardian Company in the study of catheter ablation of renal sympathetic nerves for refractory hypertension (Symplicity HTN-1), confirming that This new technology is simple and safe, and the antihypertensive effect appears early and can be maintained for a long time. During the follow-up observation for up to 2 years, no blood pressure was found to increase again, and the renal function remained stable. There are more than ten clinical studies on percutaneous renal denervation therapy being conducted or completed in many foreign centers. The results of the completed or ongoing clinical trials are encouraging. This technology is expected to be a revolution in the field of hypertension treatment sexual breakthrough.
此项技术在国内的应用尚处于起步探索阶段，该产品还未进入国内市场，阜外医院于2012年2月12日在国内经特批试用Symplicity消融导管对4例顽固性高血压患者成功实施了手术。国内有几家医院于2011年用心脏射频消融导管实施了数例肾脏去交感神经治疗，疗效目前尚未见文献报道。The application of this technology in China is still in the initial stage of exploration, and the product has not yet entered the domestic market. On February 12, 2012, Fuwai Hospital successfully implemented the Symplicity ablation catheter on 4 patients with refractory hypertension in China with special approval. surgery. In 2011, several hospitals in China implemented several cases of renal denervation with cardiac radiofrequency ablation catheter, but the curative effect has not been reported in the literature.
US 2011/0264075 A1公开了一种用于肾去交感神经的射频消融导管，Ardian公司生产的此种导管虽然在国外临床中有一定的应用，但是也存在明显的不足。首先该种导管仅能进行单点消融，由于肾去交感神经的射频消融治疗一般是绕肾动脉一周进行6-8个点的螺旋形消融，因此Ardian公司的此种导管需要消融6-8次，手术时间比较长。针对Ardian公司的消融导管不能进行多点消融的问题，US 2012/0116392 A1、US 2012/0029510 A1、CN201110117776.8、CN201110327772.2通过在多条电极杆上分别设置射频消融电极从而到达多点同时消融的目的，CN 102198015A则通过在一条螺旋形的电极杆上按照预定位置安装多个射频电极来实现多点同时消融，虽然上述设计在一定程度上实现了肾动脉内多点同时消融，但是由于射频消融电极与血管壁贴合不够紧，使得射频消融电极在消融时容易移动，而造成消融范围过大，给患者造成不必要的损伤；为了使得多个射频消融电极同时紧密贴附血管壁，US 2012/0101413A1采用了在旋形的电极杆内设置扩张球囊的方案，通过在球囊中充入液体可以使得射频消融电极与血管壁紧密贴附，但是球囊扩张时肾血流会被阻断，如果消融时间较长容易导致肾缺血，而引起不必要的并发症；为了避免肾血流被阻断US 2012/0029512 A1将球囊替换成了金属丝网球，虽然解决了肾血流被阻断的问题，但是操作上远没有球囊方便；此外人的肾动脉走行变异较大，上述这些多个射频消融电极的设计方案很难在肾动脉走行发生变异时应用，因此限制了肾去交感神经治疗的人群；而且上述多个射频消融电极的设计方案由于仅针对射频消融，因此很难将同样的设计推广用于激光消融、微波消融等。其次Ardian公司的单射频电极导管以及上述多个射频消融电极导管的导向控制不够准确，使得适用人群偏小，因此不能很好满足临床要求。再次，Ardian公司的单射频电极导管以及上述多个射频消融电极的导管都很难对消融的效果进行实时监测，因此很难在术中进行疗效检测，使得患者二次手术风险增加。以前的消融导管都是采用线控结构控制，但是线控结构不易操作，结构也较复杂，本发明提供了一种导管控制系统，结构更简便。US 2011/0264075 A1 discloses a radiofrequency ablation catheter for renal sympathetic denervation. Although this kind of catheter produced by Ardian Company has certain applications in foreign clinical practice, it also has obvious deficiencies. First of all, this kind of catheter can only be used for single-point ablation. Since the radiofrequency ablation treatment of renal denervation usually involves helical ablation at 6-8 points around the renal artery, this kind of catheter from Ardian Company needs to be ablated 6-8 times. , the operation time is relatively long. Aiming at the problem that Ardian’s ablation catheter cannot perform multi-point ablation, US 2012/0116392 A1, US 2012/0029510 A1, CN201110117776.8, and CN201110327772.2 achieve multi-point simultaneous ablation by setting radio frequency ablation electrodes on multiple electrode rods respectively. For the purpose of ablation, CN 102198015A achieves multi-point simultaneous ablation by installing multiple radio-frequency electrodes on a spiral electrode rod according to predetermined positions. Although the above design achieves multi-point simultaneous ablation in the renal artery to a certain extent, due to The radiofrequency ablation electrode is not tightly attached to the blood vessel wall, which makes the radiofrequency ablation electrode easy to move during ablation, resulting in an excessively large ablation range and causing unnecessary damage to the patient; in order to make multiple radiofrequency ablation electrodes closely adhere to the vessel wall at the same time, US 2012/0101413A1 adopts the scheme of setting an expansion balloon in the spiral electrode rod. By filling the balloon with liquid, the radiofrequency ablation electrode can be closely attached to the vessel wall, but the renal blood flow will be blocked when the balloon is expanded. Blocking, if the ablation time is long, it will easily lead to renal ischemia and unnecessary complications; in order to avoid blocking the renal blood flow, US 2012/0029512 A1 replaces the balloon with a wire tennis ball, although it solves the problem of renal blood flow The flow is blocked, but the operation is far less convenient than the balloon; in addition, the course of the human renal artery varies greatly, and the above-mentioned design schemes of multiple radiofrequency ablation electrodes are difficult to apply when the course of the renal artery varies, so it limits Renal sympathetic denervation therapy; and because the design schemes of the above multiple radiofrequency ablation electrodes are only for radiofrequency ablation, it is difficult to popularize the same design for laser ablation, microwave ablation, etc. Secondly, the guiding control of Ardian's single radiofrequency lead catheter and the above-mentioned multiple radiofrequency ablation lead catheters is not accurate enough, which makes the applicable population small, so it cannot well meet clinical requirements. Thirdly, it is difficult to monitor the effect of ablation in real time for Ardian’s single radiofrequency electrode catheter and the above-mentioned multiple radiofrequency ablation electrode catheters, so it is difficult to detect the curative effect during the operation, which increases the risk of secondary surgery for patients. The previous ablation catheters are all controlled by a wire-controlled structure, but the wire-controlled structure is not easy to operate and the structure is relatively complicated. The present invention provides a catheter control system with a simpler structure.
发明内容Contents of the invention
本发明的目的是提供了一种可实现同时多点消融、可术中实时监测消融阻断效果、机械稳定性更好的肾脏去交感神经消融导管系统The purpose of the present invention is to provide a renal sympathetic nerve ablation catheter system that can realize simultaneous multi-point ablation, monitor the ablation blocking effect in real time during the operation, and have better mechanical stability
为了实现上述目的，本发明提供了一种消融导管系统，消融导管、导引导管、控制手柄及消融发生装置，其中消融导管由下往上依次由导管体段和消融段组成；其中In order to achieve the above object, the present invention provides an ablation catheter system, an ablation catheter, a guide catheter, a control handle and an ablation generating device, wherein the ablation catheter is composed of a catheter body section and an ablation section from bottom to top;
所述导管体段与控制手柄相连；The catheter body section is connected to a control handle;
所述消融段安装有独立结构，独立结构至少为两个，所述独立结构的近端相连，所述消融段至少有一个独立结构上安装有消融头；所述消融头通过导线、导管、微波天线或光纤与控制手柄上的能量交换接头相连，所述能量交换接头通过导线、导管、微波天线或光纤与消融发生装置相连；The ablation section is equipped with an independent structure, at least two independent structures, the proximal ends of the independent structures are connected, and the ablation section has an ablation head installed on at least one independent structure; the ablation head is passed through wires, catheters, microwave The antenna or optical fiber is connected to the energy exchange joint on the control handle, and the energy exchange joint is connected to the ablation generating device through a wire, catheter, microwave antenna or optical fiber;
所述导引导管通过牵拉或推送一端附着在导引导管头端上,另一端由手柄控制的导引丝控制弯曲；或所述导引导管(7)发生顺应性弯曲或预制形变。One end of the guide catheter is attached to the head end of the guide catheter by pulling or pushing, and the other end is bent by a guide wire controlled by a handle; or the guide catheter (7) undergoes compliance bending or prefabricated deformation.
所述导管体段(4)的远端还包括与消融段(6)近端连接的可控弯曲段(5)；还包括独立设置或者不独立设置的导引导管控制柄。The distal end of the catheter body section (4) further includes a controllable bending section (5) connected to the proximal end of the ablation section (6); and a guide catheter control handle independently or not independently arranged.
进一步的，所述消融导管或/和导引导管或/和导引导管控制柄或/和控制手柄上还安装有传感器。Further, the ablation catheter or/and the guide catheter or/and the control handle of the guide catheter or/and the control handle are also equipped with sensors.
更进一步的，所述消融导管或/和导引导管或/和导引导管控制柄或/和控制手柄上还安装有传感器。Furthermore, the ablation catheter or/and the guide catheter or/and the control handle of the guide catheter or/and the control handle are further equipped with sensors.
所述独立结构之间在近端相连，两个独立结构之间包括三种形式：两个独立结构的远端连接为一体而构成消融段头端；或者两个独立结构远端彼此独立相互分离；或者两个独立结构的中间部分连接在一起，远端再相互分离。The independent structures are connected at the proximal end, and there are three forms between the two independent structures: the distal ends of the two independent structures are connected as a whole to form the head end of the ablation segment; or the distal ends of the two independent structures are independent and separated from each other ; or the middle parts of two independent structures are connected together, and the distal ends are separated from each other.
当导引导管为消融导管形变提供支点时，导引导管的头部设置与血管相通的斜孔或/和侧槽。When the guide catheter provides a fulcrum for the deformation of the ablation catheter, the head of the guide catheter is provided with an oblique hole or/and a side groove communicating with the blood vessel.
当独立结构的远端连接为一体而构成消融段头端时，导引导管头端设置缩口结构或者堵头,导引导管的头部侧壁上设置侧槽；当独立结构彼此独立相互分离时，导引导管的头端或头部侧壁上设置斜孔。When the distal ends of the independent structures are connected together to form the head end of the ablation segment, the head end of the guiding catheter is provided with a constriction structure or a plug, and the side wall of the head of the guiding catheter is provided with side grooves; when the independent structures are independent of each other , an oblique hole is set on the head end of the guiding catheter or on the side wall of the head.
当独立结构的中间部分连接在一起，远端再相互分离时，导引导管的头端或头部侧壁设置与血管相通的斜孔，斜孔(74)之后导引导管的侧壁上再设置侧槽。When the middle parts of the independent structures are connected together and the distal ends are separated from each other, the head end or the side wall of the head of the guiding catheter is provided with an oblique hole communicating with the blood vessel, and after the oblique hole (74) is placed on the side wall of the guiding catheter. Set up side slots.
当导引导管不为消融导管形变提供支点时，独立结构设置预制形变。When the guide catheter does not provide a fulcrum for the deformation of the ablation catheter, the independent structure provides prefabricated deformation.
还包括可控弯曲段设置预制形变。Also includes controllable bending segments to set prefabricated deformations.
所述独立结构上或/和可控弯曲段上还设置有检测电极；或所述消融头兼用于发放或/和接收电脉冲，为了检测消融阻断效果，消融头上、消融头周围的独立结构上或可控弯曲段上可以设置电脉冲发放或/和接收电极，电极本身可兼具有发放和接受电脉冲的能力。对于仅有一个电极的情况，优选将电极置于消融头上或消融头周围的独立结构上，在消融完成后，将电极置于消融点靠肾脏侧，发放适当的电脉冲，如果该电脉冲仍能引起血压升高，则说明消融未完全阻断肾脏交感神经。对于多个电极的情况，优选将多个电极间隔一定距离设置，此时除可以采用仅有一个电极时的消融阻断效果的检测方法外，还可以让至少两个电极形成接受和发放电脉冲的电极对，通过在消融开始前和消融完成后将至少两个电极组成的电极对置于消融损伤的前后两侧，通过比较消融术前和术后电极接收电脉冲信号之间的变化也可以判断消融效果，如果该信号未发生变化，说明肾动脉周围的肾脏交感神经仍可跨过消融损伤处传导电脉冲，即消融未完全阻断肾脏交感神经。上述两种方法均可以作为检测肾脏去交感神经术是否成功的方法，这些检测方法有助于在术中及时判断消融效果，避免二次手术。此外某些类型的消融头本身也可以兼作为发放或/和接收电脉冲信号的电极，例如射频消融电极头、液冷灌注射频电极头等。当然技术人员也可以根据消融导管的功能不设置电极。在设置多个电极时，可在消融头前后的独立结构上分别设置至少一个电极，或者可将至少一个电极设置在消融头上、消融头周围的独立结构上而将另外的电极设置在可控弯曲段与肾动脉接触的地方，抑或将消融头作为电脉冲信号的发放或接收电极而将电极设置在消融头周围的独立结构上或可控弯曲段与肾动脉接触的地方。电极的形状可以是多样的，例如可以是环状包绕独立结构，也可以是半环状，只包绕独立结构与血管接触的部分，还可以突起的小点状；但无论如何，电极的形状应有助于其与血管接触。电极将接收的信号优选通过消融导管内的导线传到控制手柄上，并优选最终传到消融发生装置。Detection electrodes are also arranged on the independent structure or/and on the controllable bending section; or the ablation head is also used to emit or/and receive electric pulses, in order to detect the ablation blocking effect, the independent ablation head and around the ablation head Electric pulse emitting and/or receiving electrodes can be arranged on the structure or on the controllable bending section, and the electrodes themselves can have both the ability to emit and receive electric pulses. For the case of only one electrode, it is preferable to place the electrode on the ablation head or on an independent structure around the ablation head. If the blood pressure can still be raised, it means that the ablation has not completely blocked the renal sympathetic nerve. For the case of multiple electrodes, it is preferable to arrange multiple electrodes at a certain distance. At this time, in addition to the detection method of the ablation blocking effect when there is only one electrode, at least two electrodes can also be used to form receiving and emitting discharge pulses. The electrode pair, by placing at least two electrodes on the front and rear sides of the ablation lesion before the start of ablation and after the completion of the ablation, and by comparing the changes in the electric pulse signals received by the electrodes before and after the ablation Judging the effect of ablation, if the signal does not change, it means that the renal sympathetic nerves around the renal artery can still conduct electrical pulses across the ablation injury, that is, the ablation has not completely blocked the renal sympathetic nerves. Both of the above two methods can be used to detect the success of renal sympathetic denervation. These detection methods are helpful to judge the ablation effect in time during the operation and avoid secondary surgery. In addition, certain types of ablation heads themselves can also serve as electrodes for emitting or/and receiving electrical pulse signals, such as radio frequency ablation electrode heads, liquid-cooled injection frequency electrode heads, and the like. Of course, the technician may not set electrodes according to the function of the ablation catheter. When multiple electrodes are set, at least one electrode can be set on the independent structure before and after the ablation head, or at least one electrode can be set on the ablation head and the independent structure around the ablation head and another electrode can be set on a controllable The place where the curved section contacts the renal artery, or the ablation head is used as the sending or receiving electrode of the electrical pulse signal and the electrodes are placed on an independent structure around the ablation head or the place where the controllable curved section contacts the renal artery. The shape of the electrode can be various, for example, it can be a ring that surrounds the independent structure, or it can be a semi-circular shape that only surrounds the part of the independent structure that is in contact with the blood vessel, or it can be a small protruding point; but in any case, the shape of the electrode The shape should facilitate its contact with the vessel. The signals received by the electrodes are preferably transmitted to the control handle through the wires in the ablation catheter, and are preferably finally transmitted to the ablation generating device.
所述导引导管的尾部侧壁上还设有用于连接注射器或注液装置进行血管内注药或注射血管内造影剂的开孔，或通过导引导管末端开口与注射器或/和注液装置相连进行血管内注药或/和注射血管内造影剂；或/和所述导引导管末端设置连接接头，连接接头与注射器、注液装置、消融导管或控制手柄连接。The tail side wall of the guide catheter is also provided with an opening for connecting a syringe or liquid injection device for intravascular drug injection or injection of intravascular contrast agent, or through the end opening of the guide catheter and the syringe or/and liquid injection device connected for intravascular drug injection or/and injection of intravascular contrast agent; or/and a connection joint is provided at the end of the guide catheter, and the connection joint is connected with a syringe, a liquid injection device, an ablation catheter or a control handle.
所述消融导管或/和导引导管制造时通过选用不同硬度的材料，或者是通过选择性的减少或/和增加部分导管的内部结构或/和管壁的结构。The ablation catheter or/and guide catheter is manufactured by selecting materials with different hardness, or by selectively reducing or/and increasing part of the internal structure of the catheter or/and the structure of the tube wall.
所述消融导管或/和导引导管上标记刻度，以指示消融导管或/和导引导管进入血管的深度以及在超声或X射线影像设备下间接测量人体结构的长度、宽度；消融导管或/和导引导管上设置不同的显影标记用于在超声或X射线影像设备下区分消融导管或/和导引导管；或/和各独立结构上设置不同的显影标记用于在超声或X射线影像设备下区分不同的独立结构；消融导管或/和导引导管上还设置标记用于在超声或X射线影像设备下区分不同的轴向旋转状态。The ablation catheter or/and guide catheter is marked with a scale to indicate the depth of the ablation catheter or/and guide catheter entering the blood vessel and indirectly measure the length and width of the human body structure under ultrasound or X-ray imaging equipment; the ablation catheter or/ Different visualization marks are set on the guide catheter for distinguishing the ablation catheter or/and the guide catheter under ultrasound or X-ray imaging equipment; or/and different visualization marks are set on each independent structure for ultrasound or X-ray imaging Different independent structures are distinguished under the equipment; markings are also set on the ablation catheter or/and guide catheter to distinguish different axial rotation states under the ultrasound or X-ray imaging equipment.
消融导管的末端或/和导引导管与控制手柄上端固定，消融导管与环形控制钮上的连接杆相连；控制手柄的下端或下侧面具有能量交换接头，来自消融头的导线、导管、微波天线或光纤穿过控制手柄的中心空腔在所述能量交换接头汇集。The end of the ablation catheter or/and the guide catheter are fixed to the upper end of the control handle, and the ablation catheter is connected to the connecting rod on the ring control knob; the lower end or lower side of the control handle has an energy exchange joint, and the wires, catheters, and microwave antennas from the ablation head Or the optical fiber passes through the central cavity of the control handle and gathers at the energy exchange joint.
消融导管通过导管体段与控制手柄上端固定，控制手柄的下端或下侧面具有能量交换接头，来自消融头的导线、导管、微波天线或光纤穿过控制手柄在所述能量交换接头汇集。The ablation catheter is fixed to the upper end of the control handle through the catheter body section. The lower end or lower side of the control handle has an energy exchange joint, and the wires, catheters, microwave antennas or optical fibers from the ablation head pass through the control handle and gather at the energy exchange joint.
所述控制手柄上设置有用于控制导引导管形变的控制钮或控制盘，所述控制钮或控制盘与导向丝连接，通过控制钮的上下移动，或通过控制盘的多向转动实现对可控弯曲段的控制；或/和环形控制钮，所述环形控制钮通过连接杆与牵引丝连接，所述连接杆位于控制手柄中的导向槽内，通过上下移动环形控制钮,实现对独立结构的控制；还包括可防止过度牵拉的缓冲结构。The control handle is provided with a control button or a control disk for controlling the deformation of the guiding catheter, and the control button or the control disk is connected with the guide wire, and the control button or the control disk can be adjusted by moving up and down or by multi-directional rotation of the control disk. Control the control of the bending section; or/and the ring control button, the ring control button is connected with the traction wire through the connecting rod, the connecting rod is located in the guide groove in the control handle, and the independent structure is realized by moving the ring control button up and down. control; also includes cushioning to prevent overstretch.
所述导引导管控制柄上设置有用于控制导引导管形变的控制钮或控制盘，所述控制钮或控制盘与导向丝连接，通过控制钮的上下移动，或通过控制盘的多向转动实现对导引导管的控制；所述导引导管控制柄与控制手柄包括可脱槽齿滑动结构，可脱槽齿滑动结构由卡槽、锥柱体凹槽、卡环、卡孔、可压钩状结构和锥柱体突出榫组成，通过可脱槽齿滑动结构进行分拆与结合。The control handle of the guiding catheter is provided with a control button or a control disk for controlling the deformation of the guiding catheter. The control button or the control disk is connected with the guide wire, and can be moved up and down by the control button or multi-directionally rotated by the control disk. Realize the control of the guide catheter; the control handle of the guide catheter and the control handle include a sliding structure with de-grooved teeth, and the de-grooved teeth sliding structure is composed of a slot, a tapered cylinder groove, a snap ring, a snap hole, a pressable Composed of a hook structure and a protruding mortise of a cone cylinder, it is separated and combined through a detachable tooth sliding structure.
所述消融发生装置设有能量输出的接头和传感器信号输入的接头，同时还设有与外接电源相接地接头；所述消融发生装置含有通过进行触屏控制来控制参数以及部分或全部信息能显示在其上的显示器和调节参数的按钮。The ablation generating device is provided with an energy output connector and a sensor signal input connector, and is also provided with a grounding connector with an external power supply; the ablation generating device includes a touch screen control to control parameters and part or all of the information functions. Display on it and buttons for adjusting parameters.
本发明提供一种可实现同时多点消融、可在线实时监测消融阻断效果、导管制作相对较简单、机械稳定性更好的肾脏去交感神经消融导管系统。The present invention provides a catheter system for ablation of renal sympathetic nerves, which can realize multi-point ablation at the same time, can monitor the ablation blocking effect in real time on-line, has relatively simple manufacture of the catheter, and has better mechanical stability.
由于本发明采用了至少两条独立结构且每条独立结构上均可设置消融头，因此可以实现多点同时消融，缩短了消融时间，进而减少了手术时间、减小了患者的痛苦，此外由于在消融时多条独立结构上的消融头将同时与血管壁接触，可以防止消融头滑动，使得消融时消融头更加稳定，防止了消融时因消融头不稳定造成的正常组织不必要的损伤，减少了消融产生的并发症，使消融过程更安全。另外，导引导管有相应的线控结构对其形变进行控制，因此导管具有较好的操控性，能适应不同走行的肾动脉，而且消融导管外加套导引导管来辅助消融导管定位，这样整个消融导管系统在血管内的定位将更准确，防止不必要的损伤，同时也可以使整个消融系统应用于更多的人群。此外该设计方案中消融导管避免了复杂的线控结构，使其结构更为简便。不仅如此，为了方便在手术中实时监测消融效果，在消融导管上还安装有检测电极以方便及时检测消融效果，避免二次手术风险。Since the present invention uses at least two independent structures and an ablation head can be arranged on each independent structure, it can realize multi-point simultaneous ablation, shorten the ablation time, further reduce the operation time, and reduce the pain of the patient. During ablation, the ablation heads on multiple independent structures will be in contact with the vessel wall at the same time, which can prevent the ablation heads from sliding, make the ablation heads more stable during ablation, and prevent unnecessary damage to normal tissues caused by the instability of the ablation heads during ablation. It reduces the complications of ablation and makes the ablation process safer. In addition, the guide catheter has a corresponding wire-controlled structure to control its deformation, so the catheter has good maneuverability and can adapt to different renal arteries, and the ablation catheter is equipped with a guide catheter to assist in the positioning of the ablation catheter. The positioning of the ablation catheter system in the blood vessel will be more accurate, unnecessary damage can be prevented, and the entire ablation system can be applied to more people. In addition, the ablation catheter in this design scheme avoids a complicated wire-controlled structure, making its structure simpler. Not only that, in order to facilitate real-time monitoring of the ablation effect during the operation, detection electrodes are installed on the ablation catheter to facilitate timely detection of the ablation effect and avoid the risk of secondary surgery.
附图说明Description of drawings
图1是根据本发明的一个实施方式主要部分的示意图。Fig. 1 is a schematic diagram of main parts according to an embodiment of the present invention.
图2是放大的消融段中两个独立结构之间的连接方式的示意图。Figure 2 is a schematic illustration of the connection between two separate structures in an enlarged ablation segment.
图3是放大的消融段中两个独立结构之间在不同的连接方式下发生形变后的示意图。Fig. 3 is a schematic diagram of deformations occurring between two independent structures in an enlarged ablation segment under different connection modes.
图4是射频消融电极头在独立结构上不同的设置方式的示意图。Fig. 4 is a schematic diagram of different arrangements of radiofrequency ablation electrode heads on independent structures.
图5是射频消融电极头为射频消融电极头时的示意图。Fig. 5 is a schematic diagram when the radiofrequency ablation electrode tip is the radiofrequency ablation electrode tip.
图6是独立结构为两个时消融段的设计简图。Fig. 6 is a schematic design diagram of the ablation segment when the independent structure is two.
图7是独立结构为三个时消融段的设计简图。Fig. 7 is a schematic design diagram of the ablation segment when the independent structure is three.
图8是独立结构为四个时消融段的设计简图。Fig. 8 is a schematic design diagram of the ablation segment when the independent structure is four.
图9是独立结构为三个且相互分离时工作状态下的简图。Fig. 9 is a schematic diagram of the working state when there are three independent structures separated from each other.
图10是独立结构为两至四个时的横截面轮廓简图。Fig. 10 is a schematic diagram of the cross-sectional profile when there are two to four independent structures.
图11是可控弯曲段为“C”形设计时工作状态下的示意图。Fig. 11 is a schematic diagram of the working state when the controllable bending section is designed in a "C" shape.
图12、图13、图14、图15是以两条独立结构为例且导引导管能够为消融导管的形变提供支点的情况下，导引导管头部的示意图。Fig. 12, Fig. 13, Fig. 14 and Fig. 15 are schematic diagrams of the head of the guiding catheter when two independent structures are taken as examples and the guiding catheter can provide a fulcrum for the deformation of the ablation catheter.
图16是以远端连接于消融段头端的两条独立结构为例的情况下，导引导管头部的示意图以及消融导管和导引导管工作状态下的示意图Figure 16 is a schematic diagram of the head of the guiding catheter and a schematic diagram of the working state of the ablation catheter and the guiding catheter in the case of two independent structures whose distal ends are connected to the head end of the ablation segment as an example
图17、图18是通过结构设计的方式改变消融导管和导引导管硬度分布的示意图。Fig. 17 and Fig. 18 are schematic diagrams of changing the hardness distribution of the ablation catheter and the guide catheter through structural design.
图19是通过调整远端连接于消融段头端的独立结构的硬度分布实现设计形变的示意图。Fig. 19 is a schematic diagram of realizing design deformation by adjusting the hardness distribution of the independent structure whose distal end is connected to the head end of the ablation section.
图20是通过调整可控弯曲段的硬度分布实现设计形变的示意图。Fig. 20 is a schematic diagram of realizing design deformation by adjusting the hardness distribution of the controllable bending section.
图21是通过调整相互分离的独立结构的硬度分布实现设计形变的示意图。Fig. 21 is a schematic diagram of realizing design deformation by adjusting the hardness distribution of independent structures separated from each other.
图22、图23是通过调整中间某处连接在一起远端再相互分离的独立结构的硬度分布实现设计形变的示意图。Fig. 22 and Fig. 23 are schematic diagrams of achieving design deformation by adjusting the hardness distribution of independent structures that are connected together somewhere in the middle and then separated from each other at the far end.
图24是导引导管尾部主要结构的示意图。Fig. 24 is a schematic diagram of the main structure of the tail of the guiding catheter.
图25是导引导管的线控结构与通过鸡肋样结构促进导引导管形成所需要的形变形态的示意图。Fig. 25 is a schematic diagram of the wire-controlled structure of the guiding catheter and the deformation form required to promote the formation of the guiding catheter through the chicken rib-like structure.
图26、图27以及图28是在以线控结构为例的情况下，几种不同类型的控制手柄的主要结构特点的示意图。Fig. 26, Fig. 27 and Fig. 28 are schematic diagrams of the main structural features of several different types of control handles in the case of the wire control structure as an example.
具体实施方式Detailed ways
下面结合附图和具体实施例，进一步阐述本发明的实施例。这些实施例应理解为仅用于说明本发明的实施例而不用于限制本发明的实施例的保护范围。在阅读了本发明的实施例记载的内容之后，技术人员可以对本发明的实施例作各种改进或修改，这些等效变化和修饰同样落入本发明的实施例权利要求所限定的范围。The embodiments of the present invention will be further described below in conjunction with the accompanying drawings and specific embodiments. These embodiments should be understood as only for illustrating the embodiments of the present invention but not for limiting the protection scope of the embodiments of the present invention. After reading the content described in the embodiments of the present invention, skilled persons can make various improvements or modifications to the embodiments of the present invention, and these equivalent changes and modifications also fall within the scope defined by the claims of the embodiments of the present invention.
图1显示了本发明的具体实施方式中主要的部件。如图1所示，该种肾脏去交感神经消融系统主要由消融导管1、导引导管7、控制手柄2及消融发生装置3组成，根据情况设置或不设置导引导管控制柄27。如图1所示，消融导管1远端(头端)游离，近端(尾端、末端)与控制手柄2相连，消融导管1由近端向远端依次至少由导管体段4和消融段6组成，其中导管体段4的近端(尾端、末端)与控制手柄2相连，消融段6的远端(头端)游离，导管体段前端还可包括可控弯曲段5，根据情况也可以在导管体段4和消融段6之间设置其他的段。优选地，消融导管1各段横截面的外轮廓最好采用圆形或类圆形，消融导管1进入到血管内的各段直径最好相近或相等。消融导管1的长度必须使得消融段6能够顺利到达双侧肾动脉指定的消融部位，一般为50--120cm，且整个消融导管1各段的最大直径优选小于所须经过血管路径中血管的最小内径，消融导管1的直径一般为1.4--2.5mm。如图1所示，其中导引导管7优选为中空管状结构，首尾两端均设有开口，导引导管7套在消融导管1外能够辅助消融导管1到达指定的消融位置。导引导管7的长度必须使得导引导管7能够顺利地引导消融导管1到达双侧肾动脉指定的消融部位，一般为50--120cm，且整个导引导管7各段的最大外径优选小于所须经过血管路径中血管的最小直径，导引导管7的直径一般为1.4--2.5mm。Figure 1 shows the main components of an embodiment of the invention. As shown in FIG. 1 , this renal denervation ablation system is mainly composed of an ablation catheter 1 , a guiding catheter 7 , a control handle 2 and an ablation generating device 3 , and the guiding catheter control handle 27 may or may not be provided according to the situation. As shown in Figure 1, the distal end (head end) of the ablation catheter 1 is free, and the proximal end (tail end, end) is connected to the control handle 2. 6 components, wherein the proximal end (tail end, end) of the catheter body section 4 is connected to the control handle 2, the distal end (head end) of the ablation section 6 is free, and the front end of the catheter body section can also include a controllable bending section 5, depending on the situation Further sections can also be arranged between the catheter body section 4 and the ablation section 6 . Preferably, the outer contour of the cross-section of each section of the ablation catheter 1 is preferably circular or almost circular, and the diameters of the sections of the ablation catheter 1 that enter the blood vessel are preferably similar or equal. The length of the ablation catheter 1 must be such that the ablation segment 6 can smoothly reach the designated ablation site of the bilateral renal arteries, generally 50--120 cm, and the maximum diameter of each segment of the entire ablation catheter 1 is preferably smaller than the minimum diameter of the blood vessel in the vascular path. Inner diameter, the diameter of the ablation catheter 1 is generally 1.4--2.5mm. As shown in FIG. 1 , the guiding catheter 7 is preferably a hollow tubular structure with openings at both ends. The guiding catheter 7 is set outside the ablation catheter 1 to assist the ablation catheter 1 to reach the designated ablation position. The length of the guiding catheter 7 must be such that the guiding catheter 7 can smoothly guide the ablation catheter 1 to the designated ablation site of the bilateral renal arteries, generally 50--120 cm, and the maximum outer diameter of each section of the entire guiding catheter 7 is preferably less than The minimum diameter of the blood vessels that must pass through the blood vessel path, the diameter of the guide catheter 7 is generally 1.4--2.5mm.
图2显示了本发明的实施例中消融段6的主要特点。如图2所示，消融段6由至少两个独立结构8组成；该独立结构8可以是柱体形、类似柱体形、半圆柱形、锥体形、类似锥体形、弧形等，各独立结构8的长度及横截面尺寸可以相等也可以不等，但优选地，所有独立结构8横截面的外轮廓围成的消融段6横截面的外轮廓最好接近可控弯曲段5横截面的外轮廓。如图2A所示，两个独立结构8的远端(头端)连接于消融段头端17(也即消融导管头端)；如图2B所示，两个独立结构8相互分离、彼此独立；如图2C所示，两个独立结构8的中间某处连接在一起远端再相互分离，其中连接点18为所述两个独立结构8连接在一起的地方。独立结构8的尾端连于导管体段4前端的可控弯曲段5。Fig. 2 shows the main features of the ablation segment 6 in the embodiment of the present invention. As shown in Figure 2, the ablation segment 6 is composed of at least two independent structures 8; the independent structures 8 can be cylindrical, similar to cylindrical, semi-cylindrical, conical, similar to conical, arc-shaped, etc., each independent structure 8 The length and cross-sectional size of each can be equal or different, but preferably, the outer contour of the cross-section of the ablation segment 6 surrounded by the outer contours of the cross-sections of all independent structures 8 is preferably close to the outer contour of the cross-section of the controllable bending segment 5 . As shown in Figure 2A, the distal ends (head ends) of the two independent structures 8 are connected to the head end 17 of the ablation segment (that is, the head end of the ablation catheter); as shown in Figure 2B, the two independent structures 8 are separated from each other and independent of each other ; As shown in FIG. 2C , the middle of the two independent structures 8 are connected together and the distal ends are separated from each other, wherein the connection point 18 is the place where the two independent structures 8 are connected together. The tail end of the independent structure 8 is connected to the controllable bending section 5 at the front end of the catheter body section 4 .
图3显示了本发明的实施例中独立结构8在不同的两个连接方式下发生形变后的情况。其中图3A显示了远端连接于消融段头端17的独立结构8发生形变后的情况，此时独立结构8的中间部分将四散隆起，一般地，以独立结构8的中间或靠近中间处隆起最为明显。图3B显示了独立结构8相互分离时发生形变后的情况，此时独立结构8将相互远离，一般地，以独立结构8的头端及其附近位置相互远离最为明显。图3C显示了独立结构8中间某处连接在一起远端再相互分离时发生形变后的情况，此时从连接点18到独立结构8头端的部分将相互远离，一般地，以独立结构8头端及其附近位置相互远离最为明显，从连接点18到独立结构8尾端(末端、远端)之间的部分将四散隆起，一般地，以连接点18到独立结构8尾端之间的部分的中间或靠近中间处隆起最为明显。FIG. 3 shows the deformation of the independent structure 8 in two different connection modes in the embodiment of the present invention. 3A shows the situation after the deformation of the independent structure 8 whose distal end is connected to the head end 17 of the ablation section. At this time, the middle part of the independent structure 8 will bulge in all directions. Generally, the middle part of the independent structure 8 will bulge at or near the middle. most obvious. FIG. 3B shows the situation after deformation occurs when the independent structures 8 are separated from each other. At this time, the independent structures 8 will move away from each other. Generally, the distance between the head ends of the independent structures 8 and its vicinity is most obvious. Figure 3C shows the situation after the deformation occurs when the distal ends are connected together somewhere in the middle of the independent structure 8 and then separated from each other. At this time, the parts from the connection point 18 to the head end of the independent structure 8 will be far away from each other. Generally, the independent structure 8 head It is most obvious that the end and its vicinity are far away from each other, and the part between the connection point 18 and the tail end (terminus, distal end) of the independent structure 8 will be scattered and uplifted. Generally, the distance between the connection point 18 and the tail end of the independent structure 8 The bulge is most pronounced in or near the middle of the section.
图4显示了本发明的实施例中射频消融电极头9在独立结构8上不同的设置方式。如图4A所示，至少有一个独立结构8上设置有射频消融电极头9；如图4B、图4C所示，每个独立结构8可以设置不只一个射频消融电极头9。射频消融电极头9主要用于对肾脏交感神经的消融阻断；射频消融电极头9应是发挥消融作用的原件，优选射频消融电极头9为射频电极头，Fig. 4 shows different arrangements of the radiofrequency ablation electrode tip 9 on the independent structure 8 in the embodiment of the present invention. As shown in FIG. 4A , at least one independent structure 8 is provided with a radiofrequency ablation electrode tip 9 ; as shown in FIGS. 4B and 4C , each independent structure 8 can be provided with more than one radiofrequency ablation electrode tip 9 . The radiofrequency ablation electrode tip 9 is mainly used for ablation and blockage of the renal sympathetic nerve; the radiofrequency ablation electrode tip 9 should be an original part for ablation, and the radiofrequency ablation electrode tip 9 is preferably a radio frequency electrode tip,
图5A-C是以两个独立结构8的远端连接于消融段头端17为例，显示了射频消融头9的主要结构特点。图5A显示了纵剖面下的主要结构特点，射频消融电极头包括射频消融电极91，优选地，射频消融电极91略突出于独立结构8的表面0.05--0.2mm，以便与血管壁接触。如图5A所示，走行于独立结构8内的射频导线101将与射频消融电极极91相连，为射频消融电极91提供能量，导线连接点191是射频导线101与射频消融电极91的连接位置。如图5A所示，信号线102与设置在射频消融电极91上或/和邻近射频消融电极91的传感器192相连，用于传输传感器192(图5B示)发送的信号；传感器192可以是不同类型的，例如：温度传感器、阻抗传感器、压力传感器等；同一类型的传感器192在独立结构8上也可不止一个(图5是以一个传感器192作为示例)；传感器192对射频消融电极91及人体的参数监控，有助于了解实时情况，及时调整治疗方案。图5B及图5C以透视方式显示了射频消融电极头9及其周围独立结构8的主要结构特点。如图5B所示，射频消融电极91(图中斜线表示部分)可以仅包绕半圆柱体的曲侧面而不包绕半圆柱体的平侧面90；如图5C所示，射频消融电极91(图中斜线表示部分)可以既包绕半圆柱体的曲侧面也包绕半圆柱体的平侧面90；当然射频消融电极91还可根据情况对其包绕的范围进行调整。图5D、图5E是以两个独立结构8的远端相互分离为例，显示了射频消融头9纵剖面的主要结构特点；其中，图5D显示的是消融头9只包绕半圆柱体的曲侧面而不包绕半圆柱体的平侧面90的情况，图5E显示的是消融头9包绕半圆柱体的曲侧面和半圆柱体的平侧面90的情况。图5D、图5E所示意的射频消融电极头的设计方案与图5A-C所示意的射频消融电极头的设计方案类似。如图5D、图5E所示，独立结构8的远端能够相互远离，类似地，走行于独立结构8内的射频导线101将与射频消融电极91相连，为射频消融电极头9提供能量，导线连接点191是射频导线101与射频消融电极91相连接的位置。如图5D、图5E所示，类似地，信号线102与设置在射频消融电极91上或/和邻近射频消融电极91的传感器192相连，用于传输传感器192发送的信号；类似地，传感器192可以是不同类型的，例如：温度传感器、阻抗传感器、压力传感器等；同一类型的传感器192在独立结构8上也可不止一个(图8是以一个传感器192作为示例)；传感器192对射频消融电极头9及人体的参数监控，有助于了解实时情况，及时调整治疗方案。如图5D所示，射频消融电极91可以仅包绕半圆柱体的曲侧面而不包绕半圆柱体的平侧面90；如图5E所示，射频消融电极91可以既包绕半圆柱体的曲侧面也包绕半圆柱体的平侧面90；当然射频消融电极91还可根据情况对其包绕独立结构8的范围进行调整。图5仅是以两个独立结构8的远端连接于消融段头端17和远端相互分离为例进行射频消融头9的设计方案说明的，因此图5所示意的射频消融头9的设计方案同样适用于独立结构8的其他连接方式以及多个独立结构8的情况；对于独立结构8的形状不为半圆柱形的情况以及对于消融头9设置位置处的独立结构8的形状有所变化的情况，也可以仿照图5所示意的设计方案进行设计。5A-C show the main structural features of the radiofrequency ablation head 9 by taking the distal ends of two independent structures 8 connected to the head end 17 of the ablation segment as an example. Fig. 5A shows the main structural features in longitudinal section. The radiofrequency ablation electrode head includes a radiofrequency ablation electrode 91. Preferably, the radiofrequency ablation electrode 91 slightly protrudes from the surface of the independent structure 8 by 0.05-0.2mm, so as to contact the blood vessel wall. As shown in FIG. 5A , the radio frequency wire 101 running in the independent structure 8 will be connected with the radio frequency ablation electrode 91 to provide energy for the radio frequency ablation electrode 91 . As shown in Figure 5A, the signal line 102 is connected to the sensor 192 arranged on or/and adjacent to the radiofrequency ablation electrode 91 for transmitting the signal sent by the sensor 192 (shown in Figure 5B); the sensor 192 can be of different types For example: temperature sensor, impedance sensor, pressure sensor etc.; The sensor 192 of same type also can be more than one on independent structure 8 (Fig. 5 is an example with a sensor 192); Parameter monitoring helps to understand the real-time situation and adjust the treatment plan in time. 5B and 5C show the main structural features of the radiofrequency ablation electrode head 9 and its surrounding independent structures 8 in a perspective manner. As shown in Figure 5B, the radiofrequency ablation electrode 91 (indicated by the oblique line in the figure) can only wrap around the curved side of the semi-cylindrical body without wrapping around the flat side 90 of the semi-cylindrical body; as shown in Figure 5C, the radiofrequency ablation electrode 91 (The portion indicated by the oblique line in the figure) can surround both the curved side of the semi-cylindrical body and the flat side 90 of the semi-cylindrical body; of course, the radiofrequency ablation electrode 91 can also adjust its surrounding range according to the situation. Fig. 5D and Fig. 5E show the main structural features of the longitudinal section of the radiofrequency ablation head 9 by taking the distal ends of the two independent structures 8 as examples; among them, Fig. 5D shows that the ablation head 9 only surrounds a semi-cylindrical body The curved side does not wrap around the flat side 90 of the semi-cylindrical, FIG. 5E shows the situation where the ablation head 9 wraps around the curved side of the semi-cylindrical and the flat side 90 of the semi-cylindrical. The design scheme of the radiofrequency ablation electrode head shown in FIG. 5D and FIG. 5E is similar to the design scheme of the radiofrequency ablation electrode head shown in FIGS. 5A-C . As shown in Figure 5D and Figure 5E, the distal ends of the independent structures 8 can be far away from each other. Similarly, the radio frequency wires 101 running in the independent structures 8 will be connected with the radio frequency ablation electrodes 91 to provide energy for the radio frequency ablation electrode heads 9, and the wires The connection point 191 is the position where the radio frequency wire 101 is connected with the radio frequency ablation electrode 91 . As shown in Fig. 5D and Fig. 5E, similarly, the signal line 102 is connected with the sensor 192 arranged on the radiofrequency ablation electrode 91 or/and adjacent to the radiofrequency ablation electrode 91, and is used to transmit the signal sent by the sensor 192; similarly, the sensor 192 Can be different types, for example: temperature sensor, impedance sensor, pressure sensor etc.; The sensor 192 of same type also can be more than one on independent structure 8 (Fig. 8 is an example with a sensor 192); The parameter monitoring of the head 9 and the human body helps to understand the real-time situation and adjust the treatment plan in time. As shown in Figure 5D, the radiofrequency ablation electrode 91 can only wrap around the curved side of the semi-cylindrical body without wrapping around the flat side 90 of the semi-cylindrical body; as shown in Figure 5E, the radiofrequency ablation electrode 91 can wrap around both The curved side also surrounds the flat side 90 of the semi-cylindrical body; of course, the range in which the radiofrequency ablation electrode 91 surrounds the independent structure 8 can be adjusted according to the situation. Fig. 5 only illustrates the design scheme of the radiofrequency ablation head 9 by taking the distal ends of two independent structures 8 connected to the head end 17 of the ablation segment and the distal ends separated from each other as an example, so the design of the radiofrequency ablation head 9 shown in Fig. 5 The scheme is also applicable to other connection modes of the independent structure 8 and the situation of multiple independent structures 8; for the case where the shape of the independent structure 8 is not semi-cylindrical and for the shape of the independent structure 8 at the position where the ablation head 9 is set In the case of , it can also be designed according to the design scheme shown in Figure 5.
图6、图7、图8分别简示了独立结构8为两至四个时消融段6的主要结构特点。图9列举了独立结构8为三个且相互分离时工作状态下的情况。图10简示了独立结构8为两至四个时的横截面轮廓。FIG. 6 , FIG. 7 , and FIG. 8 briefly illustrate the main structural features of the ablation section 6 when there are two to four independent structures 8 . Fig. 9 exemplifies the situation in the working state when there are three independent structures 8 and they are separated from each other. FIG. 10 schematically illustrates the cross-sectional profile when there are two to four independent structures 8 .
如图6所示，当独立结构8为两个时，最好每个独立结构8上都设有一个射频消融电极头9。如图6A所示，两个独立结构8的远端连接于消融段头端17，两个独立结构8最好等大，每个独立结构8长度优选为13--30mm，两个独立结构8的形变将使得两个独立结构8的中间部分相对隆起，形成类似纺锤形的结构，隆起最明显的地方一般位于独立结构8的中间或靠近中间的位置并将首先接触血管壁，此时射频消融电极头9最好设置于每个独立结构8隆起最明显的地方；每个独立结构8隆起最明显的地方可以不同；各独立结构8的中间隆起最明显的部分长度可以有所不同，此时射频消融电极头9在各独立结构8的设置位置可在同一横截面上或者不在同一横截面上。如图6B所示，两个独立结构8相互分离，两个独立结构8的长度最好相等，每个独立结构8长度优选为10--20mm，两个独立结构8的形变将使得两个独立结构8相互远离，一般独立结构8的头端及其附近位置相互远离最为明显并将首先接触血管壁，此时射频消融电极头9最好设置在各独立结构8的头端及其附近位置；若希望消融点在血管的不同横截面上，可使两个独立结构8的长度不相等，或者两个独立结构8的长度相等，但射频消融电极头9在各独立结构8头部的设置位置互不相同。如图6C所示，两个独立结构8的中间某处连接在一起远端再相互分离，两个独立结构8的长度优选相等，每个独立结构8的长度优选为20--40mm，连接点18最好选择在独立结构8远端到连接点18的部分占整个独立结构8长度30--50％的地方；如图6C所示，两个独立结构8的形变将使得连接点18到独立结构8尾端的部分相对隆起，一般以该部分中间或靠近中间的位置相对隆起最明显，而连接点18到独立结构8头端的部分相互远离，一般以独立结构8的头端及其附近位置相互远离最为明显，此时将有四个位置优先接触血管壁，即两个独立结构8的头端及其附近位置和隆起最明显的地方，最好将射频消融电极头9设置于两个独立结构8的头端及其附近位置，而电极19可设置在中间隆起最明显的地方；若希望消融点在血管的不同横截面上，可使两个独立结构8中连接点18至独立结构8头端之间的部分长度不相等，或者两个独立结构8的长度相等，连接点18至独立结构8尾端之间的独立结构8的长度也相等，但射频消融电极头9在各独立结构8头部的设置位置不相同。As shown in FIG. 6 , when there are two independent structures 8 , preferably each independent structure 8 is provided with a radiofrequency ablation electrode tip 9 . As shown in Figure 6A, the distal ends of the two independent structures 8 are connected to the head end 17 of the ablation section. The deformation will cause the middle parts of the two independent structures 8 to bulge relatively, forming a spindle-like structure. The most obvious uplift is generally located in the middle or near the middle of the independent structures 8 and will first contact the blood vessel wall. At this time, radiofrequency ablation The electrode head 9 is preferably arranged at the most obvious place where each independent structure 8 bulges; the most obvious place where each independent structure 8 bulges can be different; the length of the most obvious part of the middle bulge of each independent structure 8 can be different, at this time The arrangement positions of the radiofrequency ablation electrode tips 9 on the independent structures 8 may be on the same cross section or not on the same cross section. As shown in Figure 6B, the two independent structures 8 are separated from each other, the length of the two independent structures 8 is preferably equal, and the length of each independent structure 8 is preferably 10--20mm, and the deformation of the two independent structures 8 will make the two independent structures The structures 8 are far away from each other. Generally, the head ends of the independent structures 8 and their vicinity are the most obvious distance from each other and will first contact the blood vessel wall. At this time, the radiofrequency ablation electrode tip 9 is preferably arranged at the head ends of each independent structure 8 and its vicinity; If it is desired that the ablation point is on a different cross-section of the blood vessel, the lengths of the two independent structures 8 can be unequal, or the lengths of the two independent structures 8 can be equal, but the radiofrequency ablation electrode tip 9 is set at the head of each independent structure 8 different from each other. As shown in Figure 6C, the middle of the two independent structures 8 is connected together at the far end and then separated from each other. The lengths of the two independent structures 8 are preferably equal, and the length of each independent structure 8 is preferably 20--40mm. 18 is preferably selected at a place where the part from the far end of the independent structure 8 to the connection point 18 accounts for 30--50% of the length of the entire independent structure 8; as shown in Figure 6C, the deformation of the two independent structures 8 will make the connection point 18 to the independent The part at the tail end of the structure 8 is relatively uplifted, and generally the relative uplift is most obvious in the middle or near the middle of the part, while the part from the connection point 18 to the head end of the independent structure 8 is far away from each other, and generally the head end of the independent structure 8 and its vicinity are mutually The distance is the most obvious. At this time, there will be four positions that preferentially contact the vessel wall, that is, the head ends of the two independent structures 8 and their vicinity and the place where the bulge is most obvious. It is best to set the radiofrequency ablation electrode tip 9 on the two independent structures. 8 and its vicinity, and the electrode 19 can be set at the most prominent place in the middle; if you want the ablation point to be on different cross-sections of the blood vessel, you can make the connection point 18 in the two independent structures 8 to the head of the independent structure 8 The lengths of the parts between the ends are not equal, or the lengths of the two independent structures 8 are equal, and the lengths of the independent structures 8 between the connection point 18 and the tail ends of the independent structures 8 are also equal, but the radiofrequency ablation electrode tip 9 is in each independent structure 8 The setting position of the head is different.
如图6所示，当独立结构8为两个时，最好每个独立结构8上都设有一个射频消融头9。如图6A所示，两个独立结构8的远端连接于消融段头端17，两个独立结构8最好等大，每个独立结构8长度优选为13--16mm，两个独立结构8的形变将使得两个独立结构8的中间部分相对隆起，形成类似纺锤形的结构，隆起最明显的地方一般位于独立结构8的中间或靠近中间的位置并将首先接触血管壁，此时射频消融头9最好设置于每个独立结构8隆起最明显的地方；每个独立结构8隆起最明显的地方可以不同(类似图19B所示)；各独立结构8的中间隆起最明显的部分长度可以有所不同(类似图19D所示)，此时射频消融头9在各独立结构8的设置位置可在同一横截面上或者不在同一横截面上。如图6B所示，两个独立结构8相互分离，两个独立结构8的长度最好相等，每个独立结构8长度优选为10--6mm，两个独立结构8的形变将使得两个独立结构8相互远离，一般独立结构8的头端及其附近位置相互远离最为明显并将首先接触血管壁，此时射频消融头9最好设置在各独立结构8的头端及其附近位置；若希望消融点在血管的不同横截面上，可使两个独立结构8的长度不相等(类似图21B所示)，或者两个独立结构8的长度相等，但射频消融头9在各独立结构8头部的设置位置互不相同(类似图21C所示)。如图6C所示，两个独立结构8的中间某处连接在一起远端再相互分离，两个独立结构8的长度优选相等，每个独立结构8的长度优选为6--26mm，连接点18最好选择在独立结构8远端到连接点18的部分占整个独立结构8长度16--26％的地方；如图6C所示，两个独立结构8的形变将使得连接点18到独立结构8尾端的部分相对隆起，一般以该部分中间或靠近中间的位置相对隆起最明显，而连接点18到独立结构8头端的部分相互远离，一般以独立结构8的头端及其附近位置相互远离最为明显，此时将有四个位置优先接触血管壁，即两个独立结构8的头端及其附近位置和隆起最明显的地方，最好将射频消融头9设置于两个独立结构8的头端及其附近位置，而检测电极19可设置在中间隆起最明显的地方；若希望消融点在血管的不同横截面上，可使两个独立结构8中连接点18至独立结构8头端之间的部分长度不相等(类似图23B所示)，或者两个独立结构8的长度相等，连接点18至独立结构8尾端之间的独立结构8的长度也相等，但射频消融头9在各独立结构8头部的设置位置不相同(类似图23C所示)。As shown in FIG. 6 , when there are two independent structures 8 , preferably each independent structure 8 is provided with a radio frequency ablation head 9 . As shown in Figure 6A, the distal ends of the two independent structures 8 are connected to the head end 17 of the ablation section. The two independent structures 8 are preferably equal in size. The deformation will cause the middle parts of the two independent structures 8 to bulge relatively, forming a spindle-like structure. The most obvious uplift is generally located in the middle or near the middle of the independent structures 8 and will first contact the blood vessel wall. At this time, radiofrequency ablation The head 9 is preferably arranged at the most obvious bulge of each independent structure 8; the most obvious bulge of each independent structure 8 can be different (similar to that shown in Figure 19B); the most obvious part length of the middle bulge of each independent structure 8 can be It is different (similar to that shown in FIG. 19D ), at this time, the setting positions of the radio frequency ablation heads 9 in the independent structures 8 may be on the same cross section or not on the same cross section. As shown in Figure 6B, the two independent structures 8 are separated from each other, the length of the two independent structures 8 is preferably equal, and the length of each independent structure 8 is preferably 10--6mm, and the deformation of the two independent structures 8 will make the two independent structures The structures 8 are far away from each other. Generally, the head ends of the independent structures 8 and their vicinity are most far away from each other and will first contact the blood vessel wall. At this time, the radiofrequency ablation head 9 is preferably arranged at the head ends of each independent structure 8 and its vicinity; if It is desired that the ablation points are on different cross-sections of blood vessels, so that the lengths of the two independent structures 8 can be unequal (similar to those shown in FIG. The setting positions of the heads are different from each other (similar to that shown in Fig. 21C). As shown in Figure 6C, the middle of the two independent structures 8 is connected somewhere in the far end and then separated from each other. The lengths of the two independent structures 8 are preferably equal, and the length of each independent structure 8 is preferably 6--26mm. 18 is preferably selected at a place where the part from the far end of the independent structure 8 to the connection point 18 accounts for 16--26% of the length of the entire independent structure 8; as shown in Figure 6C, the deformation of the two independent structures 8 will make the connection point 18 to the independent The part at the tail end of the structure 8 is relatively uplifted, and generally the relative uplift is most obvious in the middle or near the middle of the part, while the part from the connection point 18 to the head end of the independent structure 8 is far away from each other, and generally the head end of the independent structure 8 and its vicinity are mutually The distance is the most obvious. At this time, there will be four positions that preferentially contact the vessel wall, that is, the head ends of the two independent structures 8 and their vicinity and the place where the bulge is most obvious. It is best to set the radiofrequency ablation head 9 on the two independent structures 8 The head end and its vicinity, and the detection electrode 19 can be set at the most obvious place in the middle; if you want the ablation point to be on different cross-sections of the blood vessel, you can make the connection point 18 in the two independent structures 8 to the head of the independent structure 8 The part lengths between the ends are not equal (similar to that shown in Figure 23B), or the lengths of the two independent structures 8 are equal, and the lengths of the independent structures 8 between the connection point 18 and the tail ends of the independent structures 8 are also equal, but the radiofrequency ablation head 9 The setting positions of the heads of each independent structure 8 are different (similar to that shown in FIG. 23C ).
如图7所示，当独立结构8为三个时，最好每个独立结构8上都设有一个射频消融电极头9。如图7A所示，三个独立结构8的远端连接于消融段头端17，三个独立结构8最好等大，每个独立结构8的长度优选为13--30mm，三个独立结构8的形变将使得三个独立结构8的中间部分四散隆起，形成类似纺锤形的结构，隆起最明显的地方一般位于独立结构8的中间或靠近中间的位置并将首先接触血管壁，各独立结构8的中间部分隆起最明显的地方最好有所不同，此时射频消融电极头9最好设置在隆起最明显的地方；或者各独立结构8的中间隆起最明显的部分长度有所不同，此时射频消融电极头9在各独立结构8上的设置位置最好不在同一横截面上。如图7B所示，三个独立结构8相互分离，独立结构8的长度优选为10--20mm，三个独立结构8的形变将使得三个独立结构8相互远离，一般以独立结构8的头端及其附近位置相互远离最为明显，此时射频消融电极头9最好设置在各独立结构8的头端及其附近位置，三个独立结构8的长度可以不等，由于三个独立结构8的长度不同，因此各射频消融电极头9首先接触血管壁的位置也不在同一横截面上，如图9所示，射频消融电极头9接触肾动脉d的位置分别位于a、b、c三个不同的横截面上；或者三个独立结构8的长度相等，但射频消融电极头9在各独立结构8头部的设置位置互不相同。三个独立结构8的中间某处连接在一起远端再相互分离，连接点18最好选择在最长的独立结构8远端到连接点18的部分占整个最长的独立结构8长度30--50％的地方，优选地，每个独立结构8长度为20--40mm；如图7C所示，为了使得消融点不在血管的同一横截面上，三个独立结构8的长度可不等，但连接点18至独立结构8尾端之间的部分长度最好是相等的，三个独立结构8的形变将使得三个独立结构8上连接点18到独立结构8尾端的部分四散隆起，一般以该部分中间或靠近中间的位置相对隆起最明显，而连接点18到独立结构8头端的部分相互远离，一般以独立结构8的头端及其附近位置相互远离最为明显，此时将有六个位置优先接触血管壁，即三个独立结构8的头端及其附近位置和隆起最明显的地方，此时射频消融电极头9最好设置在独立结构8的头端及其附近位置；或者三个独立结构8的长度相等，连接点18至独立结构8尾端之间的部分长度也相等，此时射频消融电极头9在各独立结构8头部的设置位置互不相同；如图7C所示，连接点18至独立结构8尾端之间隆起最明显的地方可设置电极19。As shown in FIG. 7 , when there are three independent structures 8 , preferably each independent structure 8 is provided with a radiofrequency ablation electrode tip 9 . As shown in Figure 7A, the distal ends of the three independent structures 8 are connected to the head end 17 of the ablation section. The three independent structures 8 are preferably equal in size, and the length of each independent structure 8 is preferably 13--30mm. The three independent structures The deformation of 8 will cause the middle parts of the three independent structures 8 to bulge in all directions, forming a spindle-like structure. The most obvious bulge is generally located in the middle or near the middle of the independent structures 8 and will first contact the blood vessel wall. The most obvious bulge in the middle part of 8 is preferably different. At this time, the radiofrequency ablation electrode tip 9 is preferably arranged at the most obvious bulge; or the length of the most obvious middle bulge of each independent structure 8 is different. It is preferable that the arrangement positions of the radiofrequency ablation electrode tips 9 on each independent structure 8 are not on the same cross section. As shown in Figure 7B, the three independent structures 8 are separated from each other. The length of the independent structures 8 is preferably 10--20mm. The deformation of the three independent structures 8 will make the three independent structures 8 far away from each other. It is most obvious that the radiofrequency ablation electrode tip 9 is set at the head end of each independent structure 8 and its vicinity. The lengths of the three independent structures 8 can be different, because the three independent structures 8 The lengths of the radiofrequency ablation electrode tips 9 are different, so the positions where the radiofrequency ablation electrode tips 9 first contact the blood vessel wall are not on the same cross section. Different cross-sections; or the lengths of the three independent structures 8 are equal, but the positions of the radiofrequency ablation electrode heads 9 on the heads of the independent structures 8 are different from each other. Somewhere in the middle of the three independent structures 8 are connected together at the far end and then separated from each other. The connection point 18 is preferably selected from the longest independent structure 8. The part from the far end to the connection point 18 accounts for the entire length of the longest independent structure 8. 30- -50% of the place, preferably, the length of each independent structure 8 is 20--40mm; as shown in Figure 7C, in order to make the ablation point not on the same cross section of the blood vessel, the lengths of the three independent structures 8 can be different, but The part lengths between the connection point 18 and the tail end of the independent structure 8 are preferably equal, and the deformation of the three independent structures 8 will cause the parts from the connection point 18 to the tail end of the independent structure 8 to scatter and swell in all directions, generally in the form of The position in the middle or near the middle of this part is the most obvious relative bulge, while the part from the connection point 18 to the head end of the independent structure 8 is far away from each other. Generally, the head end of the independent structure 8 and its vicinity are the most obvious away from each other. At this time, there will be six The position is preferentially in contact with the blood vessel wall, that is, the head ends of the three independent structures 8 and their vicinity and the place where the bulge is most obvious. At this time, the radiofrequency ablation electrode tip 9 is preferably arranged at the head ends of the independent structures 8 and its vicinity; or three The lengths of the independent structures 8 are equal, and the part lengths between the connection point 18 and the tail ends of the independent structures 8 are also equal. At this time, the positions of the radiofrequency ablation electrode tips 9 on the heads of the independent structures 8 are different from each other; as shown in FIG. 7C As shown, the electrode 19 can be arranged at the place where the bulge is most obvious between the connection point 18 and the tail end of the independent structure 8.
如图8所示，当独立结构8为四个时，最好每个独立结构8上都设置一个射频消融电极头9。如图8A所示，四个独立结构8的远端连接于消融段头端17，四个独立结构8最好等大，每个独立结构8的长度优选为13--30mm，四个独立结构8的形变将使得四个独立结构8的中间部分四散隆起，形成类似纺锤形的结构，隆起最明显的地方一般位于独立结构8的中间或靠近中间的位置并将首先接触血管壁，各独立结构8的中间部分隆起最明显的地方最好有所不同，此时射频消融电极头9最好设置在隆起最明显的地方；或者各独立结构8的中间隆起最明显的部分长度有所不同，此时射频消融电极头9在各独立结构8上的设置位置最好不在同一横截面上。如图8B所示，四个独立结构8相互分离，独立结构8的长度优选为10--20mm，四个独立结构8的形变将使得四个独立结构8相互远离，一般以独立结构8的头端及其附近位置相互远离最为明显，四个独立结构8的长度可以不等，此时射频消融电极头9优选设置在独立结构8的头端及其附近位置，由于四个独立结构8的长度不同，因此各射频消融电极头9首先接触血管壁的位置也不在同一横截面上；或者四个独立结构8的长度相等，但射频消融电极头9在各独立结构8头部的设置位置互不相同。如图8C所示，四个独立结构8的中间某处连接在一起远端再相互分离，连接点18最好选择在最长的独立结构8远端到连接点18的部分占整个最长的独立结构8长度30--50％的地方，优选地，每个独立结构8长度为20--40mm；如图8C所示，为了使得消融点不在血管的同一横截面上，四个独立结构8的长度可不等，但连接点18至独立结构8尾端之间的部分长度最好是相等的，四个独立结构8的形变将使得四个独立结构8上连接点18到独立结构8尾端的部分四散隆起，一般以该部分中间或靠近中间的位置相对隆起最明显，而连接点18到独立结构8头端的部分相互远离，一般以独立结构8的头端及其附近位置相互远离最为明显，此时将有八个位置优先接触血管壁，即四个独立结构8的头端及其附近位置和隆起最明显的地方，此时射频消融电极头9设置在独立结构8的头端及其附近位置；或者四个独立结构8的长度相等，连接点18至独立结构8尾端之间的部分长度也相等，此时射频消融电极头9在各独立结构8头部的设置位置互不相同；如图8C所示，连接点18至独立结构8尾端之间隆起最明显的地方可设置电极19。如图8D所示，四个独立结构8中有两个相对的独立结构8相互分离，而另外两个相对的独立结构8的远端连接于消融段头端17，优选地，每个独立结构8的长度为13--30mm；如图8D所示，对于远端连接于消融段头端17的两个独立结构8最好等大，这两个独立结构8的形变将使得它们的中间部分相对隆起，隆起最明显的地方一般位于这两个独立结构8的中间或靠近中间的位置并将首先接触血管壁，这两个独立结构8的中间部分隆起最明显的地方最好有所不同，射频消融电极头9优选设置在隆起最明显的地方，或者这两个独立结构8的中间隆起最明显的部分长度有所不同，此时射频消融电极头9在这两个独立结构8上的设置位置最好不在同一横截面上；如图8D所示，对于相互分离的两个独立结构8长度可不同，这两个独立结构8的形变将使得它们相互远离，一般以这两个独立结构8的头端及其附近位置相互远离最为明显，射频消融电极头9优选设置在这两个独立结构8的头端及其附近位置，或者这两个独立结构8的长度相等，而射频消融电极头9在这两个独立结构8头部的设置位置有所不同；上述设计最终将使得四个射频消融电极头9接触血管壁的位置在互不相同的横截面上。如图8E所示，四个不等长的独立结构8的远端连接于牵引丝10的不同部位，优选地，独立结构8的长度为13--30mm，牵引丝10与消融导管1的长轴中心线重合；当四个独立结构8在牵引丝10的作用下发生形变时，各独立结构8的中间部分将四散隆起，隆起最明显的地方将首先接触血管壁，由于独立结构8不等长且在牵引丝上的固定位置不同，因此隆起最明显的地方也会不同，这样将射频消融电极头9设置在这些隆起最明显的地方就保证了消融点不在肾动脉的同一横截面上。此外消融段6的横截面外轮廓最好与可控弯曲段5的横截面外轮廓相似，各独立结构8在消融段6的外轮廓范围内尽量紧凑的排布，如图10所示，当独立结构8为两至四个时，每个独立结构8最好在横截面上平分圆形。当然随着独立结构8数量的增加，独立结构8的横截面轮廓也可以采用其他设计使得各独立结构8的在消融段6的外轮廓范围内尽量紧凑的排布。对于独立结构8数量继续增加的情况，优选地采用如下设计方案，即各独立结构8的远端可连接于消融段头端17、各独立结构8相互分离和不等长的独立结构8的远端连接于牵引丝10的不同部位，这些设计方案可仿照独立结构8为三个和四个时对应的设计方案。As shown in FIG. 8 , when there are four independent structures 8 , preferably one radiofrequency ablation electrode tip 9 is arranged on each independent structure 8 . As shown in Figure 8A, the distal ends of the four independent structures 8 are connected to the head end 17 of the ablation segment. The four independent structures 8 are preferably equal in size, and the length of each independent structure 8 is preferably 13--30mm. The four independent structures The deformation of 8 will cause the middle parts of the four independent structures 8 to bulge in all directions, forming a spindle-like structure. The most obvious uplift is generally located in the middle or near the middle of the independent structures 8 and will first contact the blood vessel wall. The most obvious bulge in the middle part of 8 is preferably different. At this time, the radiofrequency ablation electrode tip 9 is preferably arranged at the most obvious bulge; or the length of the most obvious middle bulge of each independent structure 8 is different. It is preferable that the arrangement positions of the radiofrequency ablation electrode tips 9 on each independent structure 8 are not on the same cross section. As shown in Figure 8B, the four independent structures 8 are separated from each other. The length of the independent structures 8 is preferably 10--20mm. The deformation of the four independent structures 8 will make the four independent structures 8 far away from each other. It is most obvious that the end and its vicinity are far away from each other, and the lengths of the four independent structures 8 can be unequal. different, so the positions where each radiofrequency ablation electrode tip 9 first contacts the blood vessel wall are not on the same cross section; or the lengths of the four independent structures 8 are equal, but the positions of the radiofrequency ablation electrode tips 9 on the heads of each independent structure 8 are different from each other same. As shown in Figure 8C, the middle of the four independent structures 8 are connected together at some point and then separated from each other. The connection point 18 is preferably selected from the longest independent structure 8. The part from the far end to the connection point 18 accounts for the longest part of the whole Where the length of the independent structures 8 is 30--50%, preferably, the length of each independent structure 8 is 20--40mm; The lengths can be unequal, but the partial length between the connecting point 18 and the tail end of the independent structure 8 is preferably equal, and the deformation of the four independent structures 8 will make the distance between the connecting point 18 on the four independent structures 8 and the tail end of the independent structure 8 Parts are scattered and uplifted, and generally the relative uplift is most obvious in the middle or near the middle of the part, while the part from the connection point 18 to the head end of the independent structure 8 is far away from each other, and generally the head end of the independent structure 8 and its vicinity are most obviously away from each other. At this time, there will be eight positions that are preferentially in contact with the vessel wall, that is, the head ends of the four independent structures 8 and their vicinity and the place where the bulge is most obvious. position; or the lengths of the four independent structures 8 are equal, and the lengths of the parts between the connection point 18 and the tail ends of the independent structures 8 are also equal. At this time, the positions of the radiofrequency ablation electrode tips 9 on the heads of the independent structures 8 are different from each other; As shown in FIG. 8C , the electrode 19 can be provided at the place where the bulge is most obvious between the connection point 18 and the tail end of the independent structure 8 . As shown in FIG. 8D, two of the four independent structures 8 are separated from each other, and the distal ends of the other two opposite independent structures 8 are connected to the head end 17 of the ablation segment. Preferably, each independent structure The length of 8 is 13--30mm; as shown in Figure 8D, the two independent structures 8 whose distal ends are connected to the head end 17 of the ablation segment are preferably equal in size, and the deformation of these two independent structures 8 will make their middle parts Relative to the uplift, the most obvious uplift is generally located in the middle or close to the middle of the two independent structures 8 and will first contact the blood vessel wall, and the most obvious uplift in the middle parts of the two independent structures 8 is preferably different, The radiofrequency ablation electrode tip 9 is preferably arranged at the place where the bulge is the most obvious, or the length of the most obvious part of the middle bulge of the two independent structures 8 is different. At this time, the arrangement of the radiofrequency ablation electrode tip 9 on the two independent structures 8 The positions are preferably not on the same cross-section; as shown in Figure 8D, the lengths of the two independent structures 8 that are separated from each other can be different, and the deformation of the two independent structures 8 will make them far away from each other. Generally, the two independent structures 8 The head ends of the two independent structures 8 and their vicinity are far away from each other most obviously, and the radiofrequency ablation electrode head 9 is preferably arranged at the head ends of the two independent structures 8 and their vicinity, or the lengths of the two independent structures 8 are equal, and the radiofrequency ablation electrode head 9 The setting positions of the heads of the two independent structures 8 are different; the above-mentioned design will eventually make the positions where the four radiofrequency ablation electrode heads 9 contact the blood vessel wall are on different cross sections. As shown in Figure 8E, the distal ends of four independent structures 8 of unequal length are connected to different parts of the pulling wire 10. Preferably, the length of the independent structure 8 is 13--30 mm, and the length of the pulling wire 10 is the same as that of the ablation catheter 1. The center lines of the axes coincide; when the four independent structures 8 are deformed under the action of the pulling wire 10, the middle parts of the independent structures 8 will bulge in all directions, and the most obvious part of the bulge will first contact the blood vessel wall, because the independent structures 8 vary Long and with different fixed positions on the pulling wire, so the places where the bulges are most obvious will also be different. In this way, setting the radiofrequency ablation electrode tip 9 at these places where the bulges are most obvious ensures that the ablation points are not on the same cross-section of the renal artery. In addition, the cross-sectional outer contour of the ablation section 6 is preferably similar to that of the controllable bending section 5, and each independent structure 8 is arranged as compactly as possible within the outer contour of the ablation section 6, as shown in FIG. 10 , when When there are two to four independent structures 8, each independent structure 8 preferably bisects a circle in cross section. Of course, as the number of independent structures 8 increases, the cross-sectional profile of the independent structures 8 can also adopt other designs so that the independent structures 8 are arranged as compactly as possible within the outer contour range of the ablation section 6 . For the situation where the number of independent structures 8 continues to increase, it is preferable to adopt the following design scheme, that is, the distal end of each independent structure 8 can be connected to the head end 17 of the ablation section, and the distal ends of the independent structures 8 that are separated from each other and have unequal lengths. The ends are connected to different parts of the pulling wire 10, and these design schemes can be modeled on the corresponding design schemes when there are three and four independent structures 8.
设置可控弯曲段5的主要作用是有助于消融段6更方便的到达指定的消融位置，例如使得消融段6更容易通过血管的弯曲、使得消融段6更容易向指定方向偏转等。可控弯曲段5优选采用圆柱形或类圆柱形设计，根据不同的设计方案可控弯曲段5的长度有所不同。图11显示了可控弯曲段5为“C”形弯曲设计时工作状态下的情况，图25是以消融段6的独立结构8为两个时进行说明的，对于消融段6为其他设计形式时，只需要替换消融段6即可。如图11所示，可控弯曲段5形变后的形状为“C”形，实线部分的可控弯曲段5表示了一种“C”形弯曲的情况，在这种形状下，可控弯曲段5优选长度为60--120mm，可控弯曲段5将有两个地方c1和c2与血管内侧壁接触，其中c1与肾动脉a的内侧壁接触，而c2与腹主动脉b的内侧壁接触，这样有利于在消融时稳定射频消融电极头9，可控弯曲段5此时最好与其中的一个独立结构8在同一平面上，这样对于独立结构8上仅有射频消融电极头9作为电脉冲发放或/和接收电极的情况，可在c1设置电极19，这样射频消融电极头9或独立结构8上的电极19与可控弯曲段5上的电极19将形成一个发放电脉冲、一个接收电脉冲，当然为适应不同管径的肾动脉，可以在c1附近设置多个环状接收电极19；如图11所示，虚线部分的可控弯曲段5表示了另一种”C”形弯曲的情况，在这种情况下，可控弯曲段5优选长度为40--100mm，可控弯曲段5可以不与动脉的内侧壁接触，或者仅有一个地方c2与动脉的内侧壁接触，这样射频消融电极头9的稳定将主要依靠各独立结构8与动脉的内侧壁接触形成的支撑点。The main function of setting the controllable bending section 5 is to help the ablation section 6 reach the designated ablation position more conveniently, for example, making the ablation section 6 easier to pass through the bending of the blood vessel, making it easier to deflect the ablation section 6 to a designated direction, etc. The controllable bending section 5 is preferably designed in a cylindrical or quasi-cylindrical shape, and the length of the controllable bending section 5 varies according to different design schemes. Figure 11 shows the situation in the working state when the controllable bending section 5 is designed as a "C"-shaped bending. Figure 25 illustrates when there are two independent structures 8 of the ablation section 6, and the ablation section 6 is in other design forms , only the ablation segment 6 needs to be replaced. As shown in Figure 11, the deformed shape of the controllable bending section 5 is a "C" shape, and the controllable bending section 5 in the solid line represents a "C"-shaped bending situation. In this shape, the controllable bending section 5 The preferred length of the curved section 5 is 60--120mm, and the controllable curved section 5 will have two places c1 and c2 in contact with the inner wall of the blood vessel, wherein c1 is in contact with the inner wall of the renal artery a, and c2 is in contact with the inner side of the abdominal aorta b Wall contact, which is conducive to stabilizing the radiofrequency ablation electrode tip 9 during ablation, and the controllable bending section 5 is preferably on the same plane as one of the independent structures 8 at this time, so that only the radiofrequency ablation electrode tip 9 is on the independent structure 8 In the case of an electric pulse emitting or/and receiving electrode, an electrode 19 can be provided at c1, so that the electrode 19 on the radiofrequency ablation electrode tip 9 or the independent structure 8 and the electrode 19 on the controllable bending section 5 will form a sending electric pulse, A receiving electrical pulse, of course, in order to adapt to renal arteries with different diameters, multiple ring-shaped receiving electrodes 19 can be set near c1; as shown in Figure 11, the controllable bending section 5 in the dotted line represents another "C" In this case, the controllable bending section 5 preferably has a length of 40--100mm, and the controllable bending section 5 may not be in contact with the inner wall of the artery, or there is only one place c2 in contact with the inner wall of the artery , so that the stability of the radiofrequency ablation electrode tip 9 will mainly rely on the support points formed by the contact of each independent structure 8 with the inner side wall of the artery.
根据具体情况，技术人员可以对上述这些消融段6和可控弯曲段5的设计方案进行融合、改进及交叉使用，这些等效变化和修饰同样落入本发明的实施例权利要求所限定的范围。According to specific circumstances, technicians can integrate, improve and cross-use the above-mentioned design schemes of the ablation section 6 and the controllable bending section 5, and these equivalent changes and modifications also fall within the scope defined by the claims of the embodiments of the present invention .
所述的可控弯曲段5、独立结构8和导引导管7可以有预制形变，例如如图11所示，在体外制造时可以事先将可控弯曲段5预置成“C”形弯曲，使得消融段6可以顺利进入肾动脉。技术人员可以通过在可控弯曲段5、独立结构8和导引导管7中加入具有形状记忆功能的材料来实现在体外对预制形变进行调整，例如：在可控弯曲段5中加入形状记忆合金，可以先将其在体外的弯曲形态预先制成“C”形弯曲，当需要可控弯曲段5改变弯曲形态时，又可以再次将其拿出体外通过温度变化将可控弯曲段5制成其他形状的弯曲样式。The controllable bending section 5, the independent structure 8 and the guide catheter 7 can have prefabricated deformation, for example, as shown in Figure 11, the controllable bending section 5 can be pre-set into a "C"-shaped bend during in vitro manufacturing, This allows the ablation segment 6 to smoothly enter the renal artery. Technicians can adjust the prefabricated deformation in vitro by adding materials with shape memory function to the controllable bending section 5, the independent structure 8 and the guiding catheter 7, for example: adding a shape memory alloy to the controllable bending section 5 , it can be pre-formed into a "C"-shaped bending form in vitro, and when the controllable bending section 5 is required to change the bending form, it can be taken out of the body again to make the controllable bending section 5 through temperature changes Curved styles for other shapes.
所述的导引导管7的主要作用是套在消融导管1外起到引导消融导管1方向、容纳消融导管1和为消融导管1提供通道，因此导引导管7的内径因较消融导管1外径略大，此外导引导管7有时还可以起到为消融导管1的形变提供支点的作用。图12、图13、图14、图15是以两条独立结构8为例，显示了导引导管7能够为消融导管1的形变提供支点的情况下，导引导管7头部的主要结构特点；其中图12显示的是独立结构8相互分离时导引导管7头部的主要结构特点，图13显示的是独立结构8相互分离时导引导管7及独立结构8工作状态下的情况，图14显示的是独立结构8的远端连接于消融段头端17时导引导管7头部的主要结构特点，图15显示的是独立结构8中间某处连接在一起远端再相互分离时导引导管7头部的主要结构特点。图16是以远端连接于消融段头端17的两条独立结构8为例，显示了导引导管7不为消融导管1的形变提供支点的情况下，导引导管7头部的主要结构特点。The main function of the guide catheter 7 is to cover the outside of the ablation catheter 1 to guide the direction of the ablation catheter 1, accommodate the ablation catheter 1 and provide a channel for the ablation catheter 1, so the inner diameter of the guide catheter 7 is smaller than the outer diameter of the ablation catheter 1. In addition, the guide catheter 7 can also sometimes serve as a fulcrum for the deformation of the ablation catheter 1 . Figure 12, Figure 13, Figure 14, and Figure 15 take two independent structures 8 as an example, showing the main structural features of the head of the guiding catheter 7 when the guiding catheter 7 can provide a fulcrum for the deformation of the ablation catheter 1 Wherein Fig. 12 shows the main structural features of the guiding catheter 7 heads when the independent structures 8 are separated from each other, and what Fig. 13 shows is the situation under the guiding catheter 7 and the independent structures 8 working conditions when the independent structures 8 are separated from each other, Fig. 14 shows the main structural features of the head of the guiding catheter 7 when the distal end of the independent structure 8 is connected to the head end 17 of the ablation segment. The main structural features of the head of the guide tube 7. Figure 16 takes two independent structures 8 whose distal ends are connected to the head end 17 of the ablation section as an example, showing the main structure of the head of the guide catheter 7 when the guide catheter 7 does not provide a fulcrum for the deformation of the ablation catheter 1 features.
对于导引导管7能够为消融导管1的形变提供支点的情况，导引导管7的头部优选设置与血管相通的斜孔74或/和侧槽76。斜孔74和侧槽76主要作为独立结构8向导引导管7外伸出的通道，实现独立结构8与血管壁接触，当然斜孔74和侧槽76也可以作为向血管内注药或/和注射造影剂的通道。根据独立结构8数量和两两独立结构8相互连接方式的不同导引导管7头部的斜孔74和侧槽76的设置方式也不同。图12A、图12B、图12C为纵剖面示意图，图12D、图12E为透视示意图。如图12所示，当独立结构8相互分离时，在导引导管7的头端(远端)或头部侧壁上开出若干与各独立结构8相对应的斜孔74；如图12A、12D所示，斜孔74可开于导引导管7的头端，如图12B、图12C所示，斜孔74也可开于导引导管7的头部侧壁上，每个斜孔74的内径大于独立结构8的外径，一般1.4--2.4mm，每个斜孔74的倾斜角度一般为16--50度，同时斜孔74的数量优选等于独立结构8的数量，斜孔74间的连接部分75优选呈锥状，连接部分75不仅能够限制可控弯曲段5被前推出导引导管7还有助于引导独立结构8从斜孔74处被前推出。若推送消融导管1或回退导引导管7，如图12C、图13所示，独立结构8将从斜孔74内向外呈辐散状被推入血管，独立结构8头部的射频消融电极头9将优先与血管壁接触；通过控制推送消融导管1或回退导引导管7的距离以及斜孔74的倾斜度，即可控制独立结构8远端相互分离的距离及射频消融电极头9与血管壁接触的压力。对于独立结构8的远端汇集于消融段头端17的情况，图14A、图14B为纵剖面示意图，图14C为透视图。如图14A、图14C所示，当独立结构8的远端汇集于消融段头端17时，导引导管7的头端开口优选通过结构设计的方式限制消融段头端17被前推出导引导管7，优选可设置缩口结构73使导引导管7头端开口的孔径小于消融段头端17的外径(图14A所示)，抑或用堵头72封闭导引导管7的头端开口(图14B、图14C所示)；如图14所示，导引导管7的头端侧壁上优选地设置有与独立结构8的长度相近且与血管相通的侧槽76，侧槽76的长度一般为12--14mm，该侧槽76优选与独立结构8平行对应，侧槽76的宽度略大于独立结构8的外径，一般为1.4--2.4mm，并且侧槽76的数量优选等于独立结构8的数量。若推送消融导管1或回退导引导管7，如图14B所示，消融段头端17因为堵头72的限制将使得独立结构8从相应的侧槽76处隆起膨出，将使得射频消融电极头9优先与血管壁相接触；通过控制推送消融导管1或回退导引导管7的距离，即可控制独立结构8中间部分相对隆起的间隔距离及射频消融电极头9与血管壁接触的压力。对于独立结构8的中间某处连接在一起远端再相互分离的情况，导引导管7头部的设计方案结合了图12、图13、图14所示意的设计方案。如图15A所示，在导引导管7的头部侧壁上设置若干与血管相通小的斜孔74或者在导引导管7的头端设置若干小的斜孔74(类似图12A、图12D所示)，然后在斜孔74之后一定距离的导引导管7的侧壁上再设置与斜孔74相对应且与独立结构8相平行的侧槽76，斜孔74与侧槽76的间隔距离一般为2.5--5.5mm，每个斜孔的内径略大于独立结构8的外径，一般为1.4--2.4mm，每个斜孔74的倾斜角度一般为16--50度，斜孔间的连接部分75优选呈锥状，连接部分75不仅能够限制连接点18和可控弯曲段5被前推出导引导管7还有助于引导独立结构8从斜孔74处被前推出，侧槽76的宽度优选略大于独立结构8的外径，一般为1.4--2.4mm，侧槽76的长度与独立结构8近端到连接点18的部分的长度相近，一般为10--22mm，斜孔74和侧槽76的数量优选等于独立结构8的数量。若推送消融导管1或回退导引导管7，如图15B所示，独立结构8远端到连接点18之间的部分将从斜孔74内向外呈辐散状被推入血管，独立结构8头部的射频消融电极头9将优先与血管壁接触，独立结构8近端到连接点18之间的部分将从对应的侧槽76处隆起膨出，隆起最明显的地方将优先与血管壁接触；通过控制推送消融导管1或回退导引导管7的距离以及斜孔74的倾斜度能够控制独立结构8远端相互分离的距离及射频消融电极头9与血管壁接触的压力。对于部分相对的独立结构8相互分离而部分相对的独立结构8的远端连接于消融段头端17的情况，也可以借鉴图12、图13、图14、图15所示意的导引导管7头部设计方案的思路，在导引导管7的头部优选同时设置斜孔74和侧槽76；斜孔74与远端连接于消融段头端17的独立结构8相对应并优选设置在导引导管7头部的侧壁上，但也可以设置在导引导管7头端的开口处，侧槽76与相互分离的独立结构8对应并优选设置在距斜孔74一定距离的导引导管7的侧壁上，侧槽76与斜孔74不在同一直线上且分别与相应的独立结构8对应，以四条独立结构8为例，两个斜孔74在导引导管7头部的上下两个侧壁上，而两个侧槽76则在导引导管7头部的左右两个侧壁上；每个斜孔74的大小能让独立结构8通过，一般为1.4--2.4mm，同时斜孔74的数量优选等于相互分离的独立结构8的数量，斜孔74间的连接部分75优选呈锥状，连接部分75不仅能够限制消融段头端17和可控弯曲段5被前推出导引导管7还有助于引导相互分离的独立结构8从斜孔74处被前推出，侧槽76的宽度大于独立结构8的最大横径，一般为1.4--2.4mm，侧槽76与远端汇集于消融段头端17的独立结构8的长度相近，一般为12--14mm，侧槽76的数量优选等于远端汇集于消融段头端17的独立结构8的数量；若推送消融导管1或回退导引导管7，对于相互分离的独立结构8，它们将从斜孔74内向外呈辐散状被推入血管，独立结构8头部的射频消融电极头9将优先与血管壁接触，对于连接于消融段头端17的独立结构8，由于消融段头端17被斜孔74间的连接部分的限制将使得这些独立结构8从相应的侧槽76处隆起膨出，并使得射频消融电极头9优先与血管壁相接触。上述设计方案中的斜孔74和侧槽76也具有向血管内注药或注射造影剂的作用。为了方便独立结构8形成设计形变，可以通过调整独立结构8的结构设计或通过改变制造材料硬度使设计形变更容易实现。图12、图13、图14、图15是以两条独立结构8为例进行设计方案说明的，因此不局限于两条条独立结构8的情况，对于多于两条独立结构8的情况只需要按照图12、图13、图14、图15所示意的设计思路调整斜孔74与侧槽76的数量和设置位置。For the case where the guide catheter 7 can provide a fulcrum for the deformation of the ablation catheter 1 , the head of the guide catheter 7 is preferably provided with an oblique hole 74 or/and a side groove 76 communicating with blood vessels. The inclined hole 74 and the side groove 76 are mainly used as passages through which the independent structure 8 protrudes from the guide tube 7 to realize the contact between the independent structure 8 and the blood vessel wall. Of course, the inclined hole 74 and the side groove 76 can also be used as injection of medicine into the blood vessel or/and Channel for injection of contrast agent. Depending on the number of independent structures 8 and the way two independent structures 8 are connected to each other, the arrangement of the oblique hole 74 and the side groove 76 at the head of the guiding catheter 7 is also different. Fig. 12A, Fig. 12B, Fig. 12C are longitudinal sectional schematic diagrams, Fig. 12D, Fig. 12E are perspective schematic diagrams. As shown in Figure 12, when the independent structures 8 are separated from each other, a number of oblique holes 74 corresponding to the independent structures 8 are opened on the head end (distal end) or the side wall of the head of the guide catheter 7; as shown in Figure 12A , 12D, the inclined hole 74 can be opened on the head end of the guiding catheter 7, as shown in Figure 12B and Figure 12C, the inclined hole 74 can also be opened on the head side wall of the guiding catheter 7, each inclined hole The inner diameter of 74 is larger than the outer diameter of independent structure 8, generally 1.4--2.4mm, and the inclination angle of each inclined hole 74 is generally 16--50 degrees, and the number of inclined holes 74 is preferably equal to the number of independent structures 8 at the same time. The connecting portion 75 between 74 is preferably tapered, and the connecting portion 75 can not only restrict the controllable bending section 5 from being pushed out of the guide tube 7 but also help guide the independent structure 8 to be pushed forward from the inclined hole 74 . If the ablation catheter 1 is pushed or the guide catheter 7 is retracted, as shown in Figure 12C and Figure 13, the independent structure 8 will be pushed into the blood vessel in a radial manner from the inside of the oblique hole 74, and the radiofrequency ablation electrode on the head of the independent structure 8 The head 9 will be in contact with the vessel wall first; by controlling the distance of pushing the ablation catheter 1 or retreating the guiding catheter 7 and the inclination of the inclined hole 74, the distance between the distal ends of the independent structure 8 and the radiofrequency ablation electrode head 9 can be controlled. The pressure of contact with the vessel wall. For the case where the distal end of the independent structure 8 converges at the head end 17 of the ablation section, Fig. 14A and Fig. 14B are schematic longitudinal sections, and Fig. 14C is a perspective view. As shown in Figure 14A and Figure 14C, when the distal end of the independent structure 8 converges on the head end 17 of the ablation section, the opening of the head end of the guide catheter 7 is preferably designed to restrict the head end 17 of the ablation section from being pushed forward for guidance. The catheter 7, preferably, can be provided with a constriction structure 73 so that the opening diameter of the head end of the guide catheter 7 is smaller than the outer diameter of the head end 17 of the ablation section (as shown in FIG. 14A ), or the head end opening of the guide catheter 7 can be closed with a plug 72 (shown in Fig. 14B, Fig. 14C); As shown in Fig. 14, the side wall of the head end of the guide catheter 7 is preferably provided with a side groove 76 that is close to the length of the independent structure 8 and communicates with blood vessels. The length is generally 12--14mm, and the side groove 76 is preferably parallel to the independent structure 8. The width of the side groove 76 is slightly larger than the outer diameter of the independent structure 8, generally 1.4--2.4mm, and the number of side grooves 76 is preferably equal to Number of independent structures 8. If the ablation catheter 1 is pushed or the guide catheter 7 is retracted, as shown in Figure 14B, the head end 17 of the ablation segment will bulge out from the corresponding side groove 76 due to the restriction of the plug 72 at the head end 17 of the ablation segment, which will make the radiofrequency ablation The electrode tip 9 is preferentially in contact with the vessel wall; by controlling the distance of pushing the ablation catheter 1 or retracting the guiding catheter 7, the distance between the relative bulges of the middle part of the independent structure 8 and the contact distance between the radiofrequency ablation electrode tip 9 and the vessel wall can be controlled. pressure. For the situation that the middle part of the independent structure 8 is connected together and the distal ends are separated from each other, the design scheme of the head of the guiding catheter 7 combines the design schemes shown in Fig. 12 , Fig. 13 and Fig. 14 . As shown in Figure 15A, several small oblique holes 74 communicating with blood vessels are set on the head side wall of the guide catheter 7 or several small oblique holes 74 are set at the head end of the guide catheter 7 (similar to Figure 12A, Figure 12D shown), then on the side wall of the guide tube 7 at a certain distance behind the inclined hole 74, a side groove 76 corresponding to the inclined hole 74 and parallel to the independent structure 8 is set, and the interval between the inclined hole 74 and the side groove 76 The distance is generally 2.5--5.5mm. The inner diameter of each inclined hole is slightly larger than the outer diameter of the independent structure 8, generally 1.4--2.4mm. The inclination angle of each inclined hole 74 is generally 16--50 degrees. The connection part 75 between them is preferably tapered, and the connection part 75 can not only limit the connection point 18 and the controllable bending section 5 to be pushed out of the guiding guide tube 7, but also help to guide the independent structure 8 to be pushed forward from the inclined hole 74. The width of the groove 76 is preferably slightly larger than the outer diameter of the independent structure 8, generally 1.4--2.4mm, and the length of the side groove 76 is similar to the length of the part from the proximal end of the independent structure 8 to the connection point 18, generally 10--22mm. The number of inclined holes 74 and side grooves 76 is preferably equal to the number of individual structures 8 . If the ablation catheter 1 is pushed or the guide catheter 7 is retracted, as shown in Figure 15B, the part between the distal end of the independent structure 8 and the connecting point 18 will be pushed into the blood vessel in a radial manner from the inside of the oblique hole 74, and the independent structure The radiofrequency ablation electrode tip 9 on the 8 head will be in contact with the blood vessel wall first, and the part between the proximal end of the independent structure 8 and the connection point 18 will bulge out from the corresponding side groove 76, and the most obvious part of the bulge will be preferentially in contact with the blood vessel wall. Wall contact: by controlling the distance of pushing the ablation catheter 1 or retracting the guide catheter 7 and the inclination of the inclined hole 74, the distance between the distal ends of the independent structure 8 and the contact pressure of the radiofrequency ablation electrode tip 9 with the vessel wall can be controlled. For the situation where some of the opposing independent structures 8 are separated from each other and the distal ends of some of the opposing independent structures 8 are connected to the head end 17 of the ablation section, the guide catheter 7 shown in Fig. 12, Fig. 13, Fig. 14, and Fig. 15 can also be used for reference. The idea of the head design scheme is that the head of the guide catheter 7 is preferably provided with an inclined hole 74 and a side groove 76; On the side wall of the head of the guide tube 7, it can also be arranged at the opening of the head end of the guide tube 7. The side groove 76 corresponds to the independent structure 8 separated from each other and is preferably arranged on the guide tube 7 at a certain distance from the inclined hole 74. On the side wall, the side grooves 76 and the inclined holes 74 are not on the same straight line and correspond to the corresponding independent structures 8 respectively. Taking the four independent structures 8 as an example, the two inclined holes 74 are located on the upper and lower sides of the guide tube 7 head. on the side wall, while the two side grooves 76 are on the left and right side walls of the head of the guiding catheter 7; the size of each inclined hole 74 allows the independent structure 8 to pass through, generally 1.4--2.4mm, and at the same time The number of holes 74 is preferably equal to the number of independent structures 8 that are separated from each other. The connecting part 75 between the inclined holes 74 is preferably tapered. The connecting part 75 can not only restrict the head end 17 of the ablation section and the controllable bending section 5 from being pushed forward and guided The catheter 7 also helps to guide the separated independent structures 8 to be pushed forward from the inclined hole 74. The width of the side groove 76 is greater than the maximum transverse diameter of the independent structure 8, generally 1.4--2.4mm. The side groove 76 is connected to the distal end The lengths of the independent structures 8 gathered at the head end 17 of the ablation section are similar in length, generally 12--14 mm, and the number of side grooves 76 is preferably equal to the number of independent structures 8 whose distal ends gather at the head end 17 of the ablation section; if the ablation catheter 1 is pushed Or retract the guide catheter 7, for the independent structures 8 that are separated from each other, they will be pushed into the blood vessel in a radial form from the inside of the oblique hole 74, and the radiofrequency ablation electrode tip 9 at the head of the independent structure 8 will preferentially contact the blood vessel wall , for the independent structures 8 connected to the head end 17 of the ablation section, since the head end 17 of the ablation section is restricted by the connecting part between the oblique holes 74, these independent structures 8 will protrude from the corresponding side groove 76, and the radio frequency The ablation electrode tip 9 is preferentially in contact with the vessel wall. The oblique hole 74 and the side groove 76 in the above design scheme also have the function of injecting medicine or contrast agent into the blood vessel. In order to facilitate the design deformation of the independent structure 8, the design deformation can be realized more easily by adjusting the structural design of the independent structure 8 or by changing the hardness of the manufacturing material. Fig. 12, Fig. 13, Fig. 14 and Fig. 15 illustrate the design scheme with two independent structures 8 as an example, so they are not limited to the situation of two independent structures 8, only for the situation of more than two independent structures 8 It is necessary to adjust the number and setting positions of the oblique holes 74 and the side slots 76 according to the design ideas shown in Fig. 12 , Fig. 13 , Fig. 14 , and Fig. 15 .
对于导引导管7不能够为消融导管1的形变提供支点的情况，独立结构8优选设置预制形变，可控弯曲段5可以设置预制形变，然后将消融导管1压入导引导管7内，当导引导管7的头端到达指定位置后，消融导管1可从导引导管7头端的开口被推送出来，恢复预制形变。如图16A所示，将远端汇集于消融段头端17的两条独立结构8预制成类似纺锤形，将该消融导管1压入导引导管7内，由于导引导管7的限制，预制成纺锤形的两条独立结构8的中间部分将相互靠拢。如图16B所示，当导引导管7到达肾动脉a在主动脉b上的开口处时，将消融段6从导引导管7头端开口内推送出来，此时两条独立结构8将恢复成预制的类似纺锤形，附着射频消融电极头9的突出部分将优先与血管壁接触。如图16C所示，当可控弯曲段5预制成“C”形时，导引导管7可在接近肾动脉a在主动脉b上的开口处时即将消融段6从导引导管7头端开口内推送出来，由于可控弯曲段5的“C”形弯曲的存在，消融段6也能够顺利从主动脉b进入肾动脉a。图16是以远端连接于消融段头端17的两条独立结构8为例进行设计方案说明的，因此不局限于两条独立结构8的情况，也不局限于独立结构8远端连接于消融段头端17这一种两两独立结构8的连接方式，对于多于两条独立结构8的情况和两两独立结构8其他的连接方式也同样适用，例如对于相互分离的独立结构8，需要将独立结构8预制成以头端及其附近位置相互远离最为明显的状态，然后压入导引导管7，又例如对于独立结构8的中间某处连接在一起远端再相互分离的情况，需要将独立结构8远端到连接点18之间的部分预制成以头端及其附近位置相互远离最为明显的状态，而将独立结构8近端到连接点18之间的部分预制成纺锤形，然后压入导引导管7，再例如对于部分相对的独立结构8相互分离而部分相对的独立结构8的远端连接于消融段头端17的情况，需要将相互分离的独立结构8预制成以头端及其附近位置相互远离最为明显的状态，而将远端连接于消融段头端17的独立结构8预制成纺锤形，然后压入导引导管7。此外也可以在导引导管7的头部设置与独立结构8相对应的斜孔74或/和侧槽76，这样在不将消融段6前推出导引导管7的情况下，也可以实现独立结构8恢复预制形变。For the situation where the guide catheter 7 cannot provide a fulcrum for the deformation of the ablation catheter 1, the independent structure 8 is preferably provided with prefabricated deformation, and the controllable bending section 5 can be provided with a prefabricated deformation, and then the ablation catheter 1 is pressed into the guide catheter 7, when After the head end of the guide catheter 7 reaches the designated position, the ablation catheter 1 can be pushed out from the opening of the head end of the guide catheter 7 to restore the prefabricated deformation. As shown in Fig. 16A, the two independent structures 8 whose distal ends converge at the head end 17 of the ablation segment are prefabricated into a similar spindle shape, and the ablation catheter 1 is pressed into the guiding catheter 7. Due to the restriction of the guiding catheter 7, The middle parts of the two independent structures 8 which are prefabricated into a spindle shape will approach each other. As shown in Figure 16B, when the guide catheter 7 reaches the opening of the renal artery a on the aorta b, the ablation segment 6 is pushed out from the opening of the head end of the guide catheter 7, and the two independent structures 8 will recover Into a prefabricated spindle-like shape, the protruding part attached to the radiofrequency ablation electrode tip 9 will preferentially contact the vessel wall. As shown in Figure 16C, when the controllable bending section 5 is prefabricated into a "C" shape, the guide catheter 7 can remove the ablation section 6 from the guide catheter 7 when approaching the opening of the renal artery a on the aorta b. The ablation segment 6 can also smoothly enter the renal artery a from the aorta b due to the "C"-shaped bend of the controllable bending segment 5. Fig. 16 is an example of the design scheme of two independent structures 8 connected to the head end 17 of the ablation segment, so it is not limited to the situation of two independent structures 8, nor is it limited to the remote ends of the independent structures 8 connected to The connection method of two independent structures 8 at the head end 17 of the ablation segment is also applicable to the situation of more than two independent structures 8 and other connection methods of two independent structures 8, for example, for mutually separated independent structures 8, It is necessary to prefabricate the independent structure 8 in such a state that the head end and its vicinity are far away from each other, and then press it into the guide catheter 7. For example, for the case where the middle of the independent structure 8 is connected together and the distal ends are separated from each other , the part between the far end of the independent structure 8 and the connection point 18 needs to be prefabricated in a state where the head end and its vicinity are far away from each other, and the part between the proximal end of the independent structure 8 and the connection point 18 should be prefabricated into a spindle shape, and then pressed into the guide catheter 7, and then, for example, for the situation where partly opposite independent structures 8 are separated from each other and the distal ends of partly opposite independent structures 8 are connected to the head end 17 of the ablation segment, it is necessary to separate the mutually separated independent structures 8 is prefabricated in the most obvious state that the head end and its vicinity are far away from each other, and the independent structure 8 that connects the distal end to the head end 17 of the ablation segment is prefabricated into a spindle shape, and then pressed into the guide catheter 7 . In addition, an oblique hole 74 or/and a side groove 76 corresponding to the independent structure 8 can also be provided on the head of the guide catheter 7, so that the independent Structure 8 restores the precast deformation.
图17、图18显示了本发明的实施例中通过结构设计改变消融导管1和导引导管7硬度分布的方式。这种通过结构设计改变消融导管1和导引导管7硬度分布的方式并不要求各个部分的制造材料本身的硬度不同。Fig. 17 and Fig. 18 show the way of changing the hardness distribution of the ablation catheter 1 and the guide catheter 7 through structural design in the embodiment of the present invention. This way of changing the hardness distribution of the ablation catheter 1 and the guide catheter 7 through structural design does not require that the hardness of the manufacturing materials of each part is different.
如图17A、图17B所示，在消融导管1内部设置图17A和图17B所示的鸡肋样结构，即间隔d5距离设置一个横截面为图17B所示的结构，该结构中斜线表示的部分被有一定弹性的材料填充，优选高分子聚合物，空白区域a1在消融导管1内将形成一个腔室，主要用于导线、细导管、光纤等走行，当然空白区域a1并不局限于圆形，也不局限于仅有一个腔室，根据情况可以设置成其他形状(例如椭圆形、长方形等)，也可以设置更多的腔室分别走行不同的构件。如图17A、图17B所示，空白区域b1在消融导管1内也将形成一个腔室，也可走行导线、细导管、光纤等，这样空白区域a1、b1就能够分别走行不同的构件，当然空白区域b1并不局限于半圆形，也不局限于仅有一个腔室，根据情况可以设置成其他形状(例如椭圆形、长方形等)，也可以设置更多的腔室分别走行不同的构件。如图17A所示，由于在d5所包括的区域内缺乏图17B中d3和d4所包含区域内的弧形结构，因此在纵轴方向上，每个d5所包括的区域将容易发生弯曲，所有d5所包括的区域的弯曲将使图17A所示的结构形成整体弯曲。类似地，如图17C所示，d3、d4、d3’、d4’所包括的区域内设置两个图17B中b1样的空白区域，即空白区域b1、b2，而此时空白区域a1位于空白区域b1、b2之间，处在d1所包括的区域内(主要在d2和d2’围成的区域内)，图17A中d6所包括区域内的结构将被图17C所示的结构替代，而图17A中d5所包括区域内的结构将是图17C中d1所包括区域内的结构的延伸；空白区域a1在消融导管1内将形成一个腔室，用于导线、细导管、光纤等走行，当然空白区域a1并不局限于椭圆形，也不局限于仅有一个腔室；空白区域b1和b2在消融导管1内也将形成两个腔室，也可走行导线、细导管、光纤等，当然空白区域b1和b2并不局限于半圆形，也不局限于分别仅有一个腔室；由于在d5所包括的区域内缺乏图17C中d3、d4、d3’、d4’所包括区域内的弧形结构，因此在纵轴方向上，每个d5所包括的区域将容易发生弯曲，所有d5所包括的区域的弯曲将使图17A所示结构形成整体弯曲，此时由于d5两侧均缺少支撑结构，因此可以发生双向弯曲，且通过调整空白区域b1和b2的大小将使得向两个方向弯曲的难易程度不同；当然，类似地也可以在三个不同方向上设置三个图17B所示意的b1样空白区域，以实现至少三个方向的弯曲，且这种设计结构还可以以此类推。如图17D、图17E所示，当消融导管1某些部分的横截面不为圆形时，鸡肋样结构同样可以在这些消融导管1部分中实现，图17D、图17E以半圆形结构为例说明了鸡肋样结构在除圆形之外的其他形状中的实现方式，根据弯曲方向的不同，空白区域a1和b1安排的位置有所不同。例如，如图17D所示，将空白区域b1安排在空白区域a1的左边，图17A中d6所包括区域内的结构将被图17D所示的结构替代，而图17A中d5所包括区域内的结构将是图17D中d1所包括区域内的结构的延伸，这样整个立体结构将容易向空白区域b1侧弯曲；如图17E所示，将b1安排在a1的右边，图17A中d6所包括区域内的结构将被图17E所示的结构替代，而d5所包括区域内的结构将是图17E中d1所包括区域内的结构的延伸，这样整个立体结构将容易向空白区域b1侧弯曲。在图17所示的结构中，通过改变空白区域a1、b1、b2的大小、数量，以及通过改变d1、d2、d3、d4、d5、d6的大小，可以实现各段硬度的不同，例如在图17A中的某一段加宽d1，缩小d3或d4将使得这一段不容易形变，再例如某一段加宽d5将使得，这一段更容易形变；通过改变不同段内空白区域a1和b1区域的相对位置可以实现不同段非同向弯曲，例如将图17A所示意结构的下半部水平旋转180度，将使得下半部空白区域b1在图17A中的箭头侧，这样改进后的结构将有助于实现“S”形弯曲。总之，鸡肋样结构的实质是通过选择性的减少或/和增加某些导管小段的内部结构进而选择性的降低或/和提高某些导管小段内部某一侧或者某几侧的抗弯曲能力，以使得导管更易向某些方向弯曲或/和形成某些弯曲形态。As shown in Fig. 17A and Fig. 17B, the chicken rib-like structure shown in Fig. 17A and Fig. 17B is set inside the ablation catheter 1, that is, a cross-section is set at a distance of d5 to be the structure shown in Fig. 17B. It is partially filled with a material with certain elasticity, preferably a high molecular polymer. The blank area a1 will form a cavity in the ablation catheter 1, which is mainly used for running wires, thin catheters, optical fibers, etc. Of course, the blank area a1 is not limited to circular The shape is not limited to only one chamber, and can be set to other shapes (such as ellipse, rectangle, etc.) according to the situation, and more chambers can also be set to run different components respectively. As shown in Figure 17A and Figure 17B, the blank area b1 will also form a cavity in the ablation catheter 1, and can also run wires, thin catheters, optical fibers, etc., so that the blank areas a1 and b1 can run different components respectively, of course The blank area b1 is not limited to a semicircle, nor is it limited to only one chamber. It can be set in other shapes (such as ellipse, rectangle, etc.) according to the situation, and more chambers can be set to run different components respectively. . As shown in Figure 17A, since the arc structure in the area included in d3 and d4 in Figure 17B is lacking in the area included in d5, in the direction of the longitudinal axis, the area included in each d5 will easily bend, all The curvature of the region encompassed by d5 will result in an overall curvature of the structure shown in Figure 17A. Similarly, as shown in Figure 17C, two blank areas like b1 in Figure 17B are set in the area included by d3, d4, d3', and d4', that is, blank areas b1 and b2, and at this time the blank area a1 is located in the blank area Between areas b1 and b2, in the area included by d1 (mainly in the area surrounded by d2 and d2'), the structure in the area included in d6 in Figure 17A will be replaced by the structure shown in Figure 17C, and The structure in the area included in d5 in Fig. 17A will be an extension of the structure in the area included in d1 in Fig. 17C; the blank area a1 will form a cavity in the ablation catheter 1, which is used for guiding wires, thin catheters, optical fibers, etc. Of course, the blank area a1 is not limited to the oval shape, nor is it limited to only one chamber; the blank areas b1 and b2 will also form two chambers in the ablation catheter 1, and can also run wires, thin catheters, optical fibers, etc. Of course, the blank areas b1 and b2 are not limited to semicircles, nor are they limited to only one chamber respectively; Therefore, in the direction of the longitudinal axis, the area included in each d5 will easily bend, and the bending of all the areas included in d5 will make the structure shown in Figure 17A form an overall bending. At this time, since both sides of d5 are There is a lack of supporting structures, so two-way bending can occur, and by adjusting the size of the blank areas b1 and b2, the difficulty of bending in the two directions will be different; of course, it is also possible to set three in three different directions similarly Figure 17B The blank area shown in b1 can be bent in at least three directions, and this design structure can also be deduced by analogy. As shown in Figure 17D and Figure 17E, when the cross-section of some parts of the ablation catheter 1 is not circular, the chicken rib-like structure can also be realized in these parts of the ablation catheter 1, and the semicircular structure is shown in Figure 17D and Figure 17E The example illustrates the implementation of the chicken rib-like structure in shapes other than the circle. According to the different bending directions, the positions of the blank areas a1 and b1 are different. For example, as shown in Figure 17D, the blank area b1 is arranged on the left side of the blank area a1, the structure in the area included in d6 in Figure 17A will be replaced by the structure shown in Figure 17D, and the structure in the area included in d5 in Figure 17A The structure will be an extension of the structure in the area included in d1 in Figure 17D, so that the entire three-dimensional structure will easily bend to the side of the blank area b1; as shown in Figure 17E, arrange b1 on the right side of a1, and the area included in d6 in Figure 17A The structure within will be replaced by the structure shown in Figure 17E, and the structure within the region d5 will be an extension of the structure within the region d1 in Figure 17E, so that the entire three-dimensional structure will easily bend toward the blank region b1. In the structure shown in Figure 17, by changing the size and number of blank areas a1, b1, b2, and by changing the size of d1, d2, d3, d4, d5, d6, the hardness of each segment can be different, for example, in In Figure 17A, widening d1 of a certain section, narrowing d3 or d4 will make this section not easily deformed, and for example, widening d5 of a certain section will make this section easier to deform; by changing the blank areas a1 and b1 in different sections The relative position can realize non-unidirectional bending of different segments. For example, if the lower half of the structure shown in FIG. Helps achieve an "S" shape bend. In short, the essence of the chicken-rib-like structure is to selectively reduce or/and increase the internal structure of some catheter segments to selectively reduce or/and increase the bending resistance of one or several sides inside some catheter segments, In order to make the catheter easier to bend in certain directions and/and to form certain curved shapes.
图18显示了本发明的实施例中另一种通过改变结构设计进而改变硬度分布使弯曲更易实现的设计方式。该设计结构是鸡肋样结构在中空管状结构中的实现方式，该种结构优选用于中空管样结构(例如导引导管7等)。该结构主要通过改变消融导管1和导引导管7管壁中的金属丝网在不同导管小段内的排布或通过改变消融导管1和导引导管7管壁在不同导管小段中的厚度来实现的，当然这里所述的金属丝网应该理解为加固导管管壁硬度的设计结构，例如也可以是高分子材料网等，因此该种设计的实质是通过选择性的减少或/和增加某些导管小段管壁的结构进而选择性的降低或/和提高某些导管小段管壁的某一侧或者某几侧的抗弯曲能力，以使得导管更易向某些方向弯曲或形成某些弯曲形态。图18是以改变消融导管1或导引导管7管壁中的金属丝网在不同导管小段内的排布为例进行说明的。如图18A所示，图中网线表示金属丝网，从图18A的左下图可以看到，导管管壁中的金属丝网是完全覆盖导管管壁的，从图18A的左上图可以看到，导管的一侧管壁中没有金属丝网，将两个导管小段间隔相叠在一起，构成图18A的右图所示的结构，由于上方的一小段导管的一侧管壁中没有金属丝网，因此导管更易向没有金属丝网的一侧弯曲。当然也不局限于导管的一侧管壁中没有金属丝网的设计方式，如图18D所示，在两个有完整的金属丝网的导管小段之间有四条“S”形金属丝f1、f2、f3、f4，可以在f1、f2间和f3、f4间设置金属丝网，而在f2、f3间和f1、f4间不设置金属丝网，这样导管更易向没有金属丝网的两侧弯曲，同理也可以在每相邻两个“S”形金属丝间只设置一半的金属丝网，这样导管更易向没有金属丝网的四个方向弯曲，还可以只有四条“S”形金属丝而没有金属丝网，这样整个导管将容易向多个方向弯曲。此外也不局限于某些导管小段管壁的某一侧或某几侧没有金属丝网的情况，这可以通过改变金属丝网的孔径、密度、金属丝的宽窄等方式实现某些导管小段管壁的某一侧或某几侧较其他导管壁软或硬；根据情况“S”形金属丝的数量可以调整，同时“S”形金属丝也可以是其他形态，例如“Z”形等。图18A的结构可以按照图18B所示的侧面观图排布，这样整个导管段的弯曲方向将是一致的；图18A的结构可以按照图18C所示的侧面观图排布，这样整个导管段上下部分的弯曲方向不一致的，通过这种方式就可以借助一根导向丝70实现复杂弯曲，例如将导向丝70从图18C中d3和d3’相交的区域穿过将更易实现“S”形弯曲。如图18B和图18C所示，还可以通过调整d1、d3、d3’、d4、d5的宽度来改变导管各段弯曲的难易程度。此外整个结构也不局限于导管横截面为圆形的情况，导管横截面为半圆、正方形等形状时仍然可以按照该思路进行设计，但此时需要考虑到这些形状对导向丝70以及鸡肋样结构本身硬度的影响。FIG. 18 shows another design method in an embodiment of the present invention that changes the structure design and then changes the hardness distribution to make bending easier. This design structure is a realization of a chicken rib-like structure in a hollow tubular structure, and this structure is preferably used for a hollow tubular structure (such as the guiding catheter 7, etc.). This structure is mainly achieved by changing the arrangement of the wire mesh in the walls of the ablation catheter 1 and the guide catheter 7 in different catheter segments or by changing the thickness of the walls of the ablation catheter 1 and the guide catheter 7 in different catheter segments Of course, the wire mesh mentioned here should be understood as a design structure that reinforces the hardness of the catheter tube wall, for example, it can also be a polymer material mesh, etc. Therefore, the essence of this design is to selectively reduce or/and increase some The structure of the tube wall of the small segment of the catheter further selectively reduces or/and increases the bending resistance of one or several sides of the tube wall of the small segment of the catheter, so that the catheter is more likely to bend in certain directions or form certain bending shapes. FIG. 18 illustrates changing the arrangement of the wire mesh in the tube wall of the ablation catheter 1 or guide catheter 7 in different catheter segments as an example. As shown in Figure 18A, the mesh wire in the figure represents the wire mesh, as can be seen from the lower left diagram of Figure 18A, the wire mesh in the catheter tube wall completely covers the catheter tube wall, as can be seen from the upper left diagram of Figure 18A, There is no wire mesh in the side wall of the catheter, and two small catheter sections are stacked together at intervals to form the structure shown in the right diagram of Figure 18A, because there is no wire mesh in the side wall of the upper section of the catheter , so the catheter bends more easily to the side without the wire mesh. Of course, it is not limited to the design method that there is no wire mesh in the side wall of the catheter. As shown in Figure 18D, there are four "S" shaped wires f1, f2, f3, f4, wire mesh can be set between f1, f2 and f3, f4, and no wire mesh is set between f2, f3 and f1, f4, so that the catheter is easier to go to the two sides without wire mesh In the same way, only half of the wire mesh can be set between every two adjacent "S"-shaped wires, so that the catheter is easier to bend in four directions without wire mesh, and there can be only four "S"-shaped metal wires Wire instead of wire mesh, so the whole catheter will bend easily in multiple directions. In addition, it is not limited to the situation that there is no wire mesh on one side or some sides of the wall of some small sections of catheters. This can be realized by changing the aperture, density, and width of wire meshes of some catheters. One or several sides of the wall are softer or harder than other catheter walls; the number of "S"-shaped wires can be adjusted according to the situation, and the "S"-shaped wires can also be in other shapes, such as "Z" shape, etc. The structure of Figure 18A can be arranged according to the side view shown in Figure 18B, so that the bending direction of the entire catheter section will be consistent; the structure of Figure 18A can be arranged according to the side view shown in Figure 18C, so that the entire catheter section If the bending directions of the upper and lower parts are inconsistent, in this way, complex bending can be realized with the help of a guide wire 70. For example, passing the guide wire 70 through the area where d3 and d3' intersect in Figure 18C will make it easier to achieve "S" shape bending . As shown in Fig. 18B and Fig. 18C, the degree of difficulty of bending each segment of the catheter can also be changed by adjusting the widths of d1, d3, d3', d4, and d5. In addition, the entire structure is not limited to the case where the cross-section of the catheter is circular. When the cross-section of the catheter is semicircular, square, etc., it can still be designed according to this idea. Influence of its own hardness.
图17、图18所显示的通过结构设计改变消融导管1和导引导管7硬度的方式，还可以通过改变制造材料的硬度来实现，例如导管各小段的横截面可以均是图18B的设计方式，但是某些小段的横截面上d3、d4所包括的区域制造材料较另一些小段硬，那么这些小段将不容易发生弯曲。The way of changing the hardness of the ablation catheter 1 and the guide catheter 7 through structural design shown in Figure 17 and Figure 18 can also be realized by changing the hardness of the manufacturing material, for example, the cross-section of each small section of the catheter can be designed in the way shown in Figure 18B , but on the cross-section of some small sections d3, d4 included in the regional manufacturing material is harder than other small sections, then these small sections will not be easy to bend.
图19是以两条独立结构8远端连接于消融段头端17为例，显示了本发明的实施例中如何通过调整独立结构8的硬度分布使设计的形变更易实现。如图19A所示，两条独立结构8a、8b弯曲形态彼此相互对称，为了方便为半圆柱形的两条独立结构8a、8b向外相对隆起，可以采用图17或/和图18所示意的鸡肋样结构，当采用图17所示意的鸡肋样结构时，独立结构8可采用图17D所示的设计方案，其中虚线cc所示的横截面的形态优选为图17D所示；当采用图18所示意的鸡肋样结构时，独立结构8中的空白部分应理解为独立结构8管壁间隔一定距离的结构硬度降低，例如通过去掉金属丝网、改变金属丝网的密度等。如图19B、图19C、图19D所示，两条独立结构8的弯曲形态也可不对称，这对于独立结构8多于两条时是十分必要的，它有助于使得消融点处在不同的肾动脉横截面上；与图19A所示意的鸡肋样结构类似，图19B、图19C、图19D所示意的设计方案也可采用图17或/和图18所示意的鸡肋样结构，为了实现不同的弯曲形态，可以通过调整各独立结构8上鸡肋样结构的布置方式实现各段硬度的不同，在曲率较大的地方硬度优选较小，更易实现弯曲。图19中独立结构8a、8b的空白部分表示各独立结构8上硬度较小的部分，因此通过调整独立结构8a、8b上空白部分的大小、形态、分部密度等能够改变鸡肋样结构的硬度分布，进而改变弯曲形态。如图19B所示，在独立结构8a中射频消融电极头9至独立结构8a尾端的部分和独立结构8b中射频消融电极头9至消融段头端17的部分曲率较大，因此空白部分的也较大和较密。类似地，图19C中，为了实现独立结构8形变后两个射频消融电极头9到消融段6长轴中心线的距离相等，在两条独立结构8长度相等的情况下，独立结构8b设计成了近端不易弯曲而远端及中间部分易发生弯曲，因此独立结构8b的远端及中间部分空白部分也更密集，使其更易弯曲。图19D中，独立结构8形变后两个射频消融电极头9到消融段6长轴中心线的距离不相等，在两条独立结构8长度相等的情况下，独立结构8的中间隆起最明显的部分在两条独立结构8上的长度不同，独立结构8b的中间隆起最明显的部分较长，这就要求独立结构8b的其他部分曲率更大，更易弯曲，因此独立结构8b的远端及近端的空白部分也更大、更密集。如图19所示，空白部分的形状也可以是多变的，可以是图19A、图19C、图19D所示的形状，也可以是图19B所示的形状，当然技术人员还可以根据具体实际设计其他形状。图19是以两条独立结构8为例进行设计方案说明的，因此不局限于两条独立结构8的情况，对于多于两条独立结构8的情况也同样适用。此外图19中独立结构8上的空白部分应理解为独立结构8间隔一定距离的结构硬度降低，这种硬度下降不仅可以通过改变结构设计的方式实现也可以通过改变材料硬度的方式实现。对于技术人员需要独立结构8形成其他弯曲形态的情况，可以对图19中独立结构8的空白部分进行相应调整。Fig. 19 is an example where the distal ends of two independent structures 8 are connected to the head end 17 of the ablation section, showing how to adjust the hardness distribution of the independent structures 8 to facilitate the realization of the designed deformation in the embodiment of the present invention. As shown in Figure 19A, the curved shapes of the two independent structures 8a and 8b are symmetrical to each other. For the convenience of the two independent structures 8a and 8b which are semi-cylindrical and bulge outward relative to each other, the structure shown in Figure 17 or/and Figure 18 can be used. Chicken rib-like structure, when the chicken rib-like structure shown in Figure 17 is adopted, the independent structure 8 can adopt the design scheme shown in Figure 17D, wherein the shape of the cross section shown by the dotted line cc is preferably as shown in Figure 17D; when using Figure 18 In the chicken-rib-like structure shown, the blank part in the independent structure 8 should be understood as the structural hardness of the independent structure 8 with a certain distance between the tube walls, for example, by removing the wire mesh, changing the density of the wire mesh, etc. As shown in Figure 19B, Figure 19C, and Figure 19D, the curved shape of the two independent structures 8 can also be asymmetrical, which is very necessary when there are more than two independent structures 8, and it helps to make the ablation points at different On the cross-section of the renal artery; similar to the chicken-rib-like structure shown in Figure 19A, the design scheme shown in Figure 19B, Figure 19C, and Figure 19D can also adopt the chicken-rib-like structure shown in Figure 17 or/and Figure 18, in order to achieve different The bending shape of each segment can be realized by adjusting the arrangement of chicken rib-like structures on each independent structure 8. The hardness of each section is different, and the hardness of the place with larger curvature is preferably smaller, and it is easier to realize bending. The blank parts of the independent structures 8a and 8b in Fig. 19 represent the parts with less hardness on the independent structures 8, so the hardness of the chicken rib-like structure can be changed by adjusting the size, shape, and subdivision density of the blank parts on the independent structures 8a and 8b. distribution, thereby changing the bending shape. As shown in Figure 19B, the part from the radiofrequency ablation electrode tip 9 to the tail end of the independent structure 8a in the independent structure 8a and the part from the radiofrequency ablation electrode tip 9 to the head end 17 of the ablation section in the independent structure 8b have relatively large curvatures, so the blank part is also Larger and denser. Similarly, in FIG. 19C , in order to realize that the distances from the two radiofrequency ablation electrode tips 9 to the centerline of the long axis of the ablation segment 6 are equal after deformation of the independent structure 8, when the lengths of the two independent structures 8 are equal, the independent structure 8b is designed as The proximal end is not easy to bend and the distal end and the middle part are easy to bend, so the blank parts of the distal end and the middle part of the independent structure 8b are also denser, making it easier to bend. In Fig. 19D, after the deformation of the independent structure 8, the distances from the two radiofrequency ablation electrode tips 9 to the centerline of the long axis of the ablation section 6 are not equal. When the lengths of the two independent structures 8 are equal, the middle bulge of the independent structure 8 is the most obvious The lengths of the parts on the two independent structures 8 are different, and the most obvious part of the middle bulge of the independent structure 8b is longer, which requires that other parts of the independent structure 8b have greater curvature and are more flexible. The white space at the end is also larger and denser. As shown in Figure 19, the shape of the blank part can also be changeable, it can be the shape shown in Figure 19A, Figure 19C, Figure 19D, or the shape shown in Figure 19B, of course the technician can also according to the actual situation Design other shapes. FIG. 19 illustrates the design scheme by taking two independent structures 8 as an example, so it is not limited to the situation of two independent structures 8 , and is also applicable to the situation of more than two independent structures 8 . In addition, the blank part on the independent structure 8 in Fig. 19 should be understood as the reduction of the structural hardness of the independent structures 8 at a certain distance, which can be realized not only by changing the structural design but also by changing the hardness of the material. For the situation that technicians need the independent structure 8 to form other bending shapes, corresponding adjustments can be made to the blank part of the independent structure 8 in FIG. 19 .
图21是以两条独立结构8为例，显示了本发明的实施例中独立结构8相互分离时如何通过调整独立结构8的硬度分布使设计的形变更易实现。图21中独立结构8上的空白部分表示的意义应理解为独立结构8间隔一定距离的结构硬度降低，这种硬度降低不仅可以通过改变结构设计的方式实现也可以通过改变材料硬度的方式实现，因此可以通过调整空白部分的大小、形态、分布密度等改变独立结构8的硬度分布使其更易弯曲成为所需要的形态。与图19所示意的独立结构8连接于消融段头端17时的结构设计思路相似，图21所示意的设计方案优选地采用鸡肋样结构，采用图17所示或/和图18所示的鸡肋样设计均可。如图21所示，在靠近独立结构8头端的部分，空白部分优选被设置在独立结构8靠消融段6中心线的部分，而在独立结构8的中间部分和尾部，空白部分优选被设置在独立结构8远离消融段6中心线的部分；当然也可以将空白部分均设置在独立结构8靠消融段6中心线的部分或独立结构8远离消融段6中心线的部分。图21B、图21C是以两条独立结构8为例说明如何实现消融点在不同的肾动脉横截面上。如图21B所示，两条独立结构8a、8b的长度不等，由于两条独立结构8的长度不同而射频消融电极头9均设置在每条独立结构8的头部，因此能够实现消融点在不同的肾动脉横截面上。如图21C所示，两条独立结构8a、8b的长度也可相等且内部结构基本是镜面对称的，只是射频消融电极头9的附着位置有所不同，独立结构8a上的射频消融电极头9a更靠近独立结构8的远端，通过这种方式也能够实现消融点在不同的肾动脉横截面上。图21是以两条独立结构8为例进行设计方案说明的，因此不局限于两条独立结构8的情况，对于多于两条独立结构8的情况也同样适用。此外对于技术人员需要独立结构8形成其他弯曲形态的情况，可以对图21中独立结构8的空白部分进行相应调整。Fig. 21 takes two independent structures 8 as an example, showing how to adjust the hardness distribution of the independent structures 8 to facilitate the design deformation when the independent structures 8 are separated from each other in the embodiment of the present invention. The meaning of the blank part on the independent structure 8 in Fig. 21 should be understood as that the hardness of the structures separated by a certain distance from the independent structures 8 is reduced. This reduction in hardness can be realized not only by changing the structure design but also by changing the hardness of the material. Therefore, the hardness distribution of the independent structure 8 can be changed by adjusting the size, shape, and distribution density of the blank portion to make it easier to bend into a desired shape. Similar to the structural design ideas when the independent structure 8 is connected to the head end 17 of the ablation segment shown in FIG. 19, the design scheme shown in FIG. Chicken rib-like design can be. As shown in Figure 21, in the part close to the head end of the independent structure 8, the blank part is preferably set at the part of the independent structure 8 close to the centerline of the ablation segment 6, while at the middle part and the tail of the independent structure 8, the blank part is preferably set at The part of the independent structure 8 away from the centerline of the ablation segment 6 ; of course, the blank part can also be set in the part of the independent structure 8 close to the centerline of the ablation segment 6 or the part of the independent structure 8 far away from the centerline of the ablation segment 6 . Fig. 21B and Fig. 21C take two independent structures 8 as an example to illustrate how to realize ablation points on different renal artery cross-sections. As shown in Figure 21B, the lengths of the two independent structures 8a and 8b are not equal. Since the lengths of the two independent structures 8 are different and the radiofrequency ablation electrode tip 9 is set on the head of each independent structure 8, the ablation point can be realized. in different renal artery cross-sections. As shown in Figure 21C, the lengths of the two independent structures 8a and 8b can also be equal and the internal structures are basically mirror-symmetrical, but the attachment position of the radiofrequency ablation electrode tip 9 is different. The radiofrequency ablation electrode tip 9a on the independent structure 8a Closer to the distal end of the independent structure 8, in this way it is also possible to achieve ablation points on different renal artery cross-sections. FIG. 21 illustrates the design scheme by taking two independent structures 8 as an example, so it is not limited to the situation of two independent structures 8 , and is also applicable to the situation of more than two independent structures 8 . In addition, for the case where the technician needs the independent structure 8 to form other curved shapes, corresponding adjustments can be made to the blank part of the independent structure 8 in FIG. 21 .
图22、图23是以两条独立结构8为例，显示了独立结构8的中间某处连接在一起远端再相互分离时如何通过调整独立结构8的硬度分布使设计的形变更易实现。图23中独立结构8上的空白部分表示的意义应理解为独立结构8间隔一定距离的结构硬度降低，这种硬度降低不仅可以通过改变结构设计的方式实现也可以通过改变材料硬度的方式实现，因此可以通过调整空白部分的大小、形态、分布密度等改变独立结构8的硬度分布使其更易弯曲成为所需要的形态。如图22所示，当独立结构8为两条时，可将两条独立结构8的连接点18做成连接关节，连接关节可通过闩体e将半圆柱形的独立结构8a、8b连接在一起，并能相对转动；当推送消融导管1或回退导引导管7使连接点18处的连接关节接触到导引导管7头部斜孔74间的连接部分75时，两条独立结构8的远端将相互远离，附着于独立结构8头部的射频消融电极头9将与血管壁接触；为了使射频消融电极头9与血管壁接触面积更大，如图22所示，两条独立结构8的头部半圆柱形的方向为横向的半圆柱形，而独立结构8的其他部分为纵向的半圆柱形；为了使图22所示的弯曲形态更容易形成，同样也可以采用鸡肋样结构，靠外的独立结构8b由于弯曲开口向下，因此可以间隔一定距离在独立结构8b的下侧设置硬度减弱的部分，同样地，靠内的独立结构8b由于弯曲开口向上，因此可以间隔一定距离在独立结构8a的上侧设置硬度减弱的部分；若采用图17所示意的鸡肋样结构，图22中虚线cc1、cc2横截面的截面放大图即为图22中上、下两幅半圆形小图，则图17A中d6所包括区域在图22中独立结构8a、8b的截面横图即分别为图22中下、上两幅半圆形小图。与图19所示意的独立结构8连接于消融段头端17时的结构设计思路相似，图23所示意的设计方案也优选采用鸡肋样结构，采用图17所示或/和图18所示的鸡肋样设计均可。如图23所示，在靠近独立结构8头端的部分，空白部分优选被设置在独立结构8靠消融段6中心线的部分，在其后到连接点18的部分，空白部分优选被设置在独立结构8远离消融段6中心线的部分，在连接点18到独立结构8末端的部分，空白部分优选被设置在独立结构8靠消融段6中心线的部分；当然也可以将空白部分均设置在独立结构8靠消融段6中心线的部分或独立结构8远离消融段6中心线的部分，且技术人员可根据情况对空白部分的设置位置进行调整。图23B、图23C是以两条独立结构8为例说明如何实现消融点在不同的肾动脉横截面上。如图23B所示，两条独立结构8a、8b的长度不等，但连接点18到独立结构8尾端的部分长度是相等的，由于两条独立结构8的长度不同而射频消融电极头9均设置在每条独立结构8的头部，因此也可实现消融点在不同的肾动脉横截面上。如图23C所示，两条独立结构8a、8b的长度也可相等且内部结构基本是镜面对称的，只是射频消融电极头9的附着位置有所不同，独立结构8a上的射频消融电极头9a更靠近独立结构8的远端，通过这种方式能够实现消融点在不同的肾动脉横截面上。图23是以两条独立结构8为例进行设计方案说明的，因此不局限于两条独立结构8的情况，对于多于两条独立结构8的情况也同样适用。此外对于技术人员需要独立结构8形成其他弯曲形态的情况，可以对图23中独立结构8的空白部分进行相应调整。Fig. 22 and Fig. 23 take two independent structures 8 as an example, showing how to adjust the hardness distribution of the independent structures 8 to facilitate the design deformation when the middle of the independent structures 8 is connected together and the distal ends are separated from each other. The meaning of the blank part on the independent structure 8 in Fig. 23 should be understood as the structure hardness reduction of the independent structure 8 at a certain distance, this hardness reduction can be realized not only by changing the structure design but also by changing the hardness of the material. Therefore, the hardness distribution of the independent structure 8 can be changed by adjusting the size, shape, and distribution density of the blank portion to make it easier to bend into a desired shape. As shown in Figure 22, when there are two independent structures 8, the connection points 18 of the two independent structures 8 can be made into joint joints, and the joint joints can connect the semi-cylindrical independent structures 8a, 8b to each other through the latch e. together, and can rotate relatively; when the ablation catheter 1 is pushed or the guide catheter 7 is retracted so that the connecting joint at the connection point 18 touches the connection part 75 between the oblique holes 74 on the head of the guide catheter 7, the two independent structures 8 The distal ends of the two will be far away from each other, and the radio frequency ablation electrode tip 9 attached to the head of the independent structure 8 will be in contact with the blood vessel wall; in order to make the contact area between the radio frequency ablation electrode tip 9 and the blood vessel wall larger, as shown in Figure 22, two independent The direction of the semi-cylindrical head of the structure 8 is a horizontal semi-cylindrical shape, while the other parts of the independent structure 8 are longitudinal semi-cylindrical shapes; in order to make the curved shape shown in Figure 22 easier to form, a chicken rib shape can also be used Structure, since the outer independent structure 8b is bent downwards, it is possible to set a part with weakened hardness on the lower side of the independent structure 8b at a certain distance. Set the portion with weakened hardness on the upper side of the independent structure 8a; if the chicken rib-like structure shown in Figure 17 is adopted, the cross-sectional enlarged view of the dotted line cc1 and cc2 in Figure 22 is the upper and lower semicircles in Figure 22 If the shape is small, then the cross-sectional cross-sectional views of the independent structures 8a and 8b in FIG. 22 in the area included in d6 in FIG. 17A are the lower and upper semicircular small diagrams in FIG. Similar to the structural design ideas when the independent structure 8 is connected to the head end 17 of the ablation segment shown in FIG. 19, the design scheme shown in FIG. Chicken rib-like design can be. As shown in Figure 23, in the part close to the head end of the independent structure 8, the blank part is preferably set at the part of the independent structure 8 close to the centerline of the ablation segment 6, and at the part to the connection point 18 thereafter, the blank part is preferably set at the independent structure 8. The part of the structure 8 away from the centerline of the ablation segment 6, and the part between the connection point 18 and the end of the independent structure 8, the blank part is preferably set at the part of the independent structure 8 close to the centerline of the ablation segment 6; of course, the blank part can also be set at The part of the independent structure 8 close to the centerline of the ablation segment 6 or the part of the independent structure 8 away from the centerline of the ablation segment 6 , and technicians can adjust the setting position of the blank part according to the situation. Fig. 23B and Fig. 23C take two independent structures 8 as an example to illustrate how to realize ablation points on different renal artery cross-sections. As shown in Figure 23B, the lengths of the two independent structures 8a and 8b are not equal, but the lengths from the connection point 18 to the tail end of the independent structure 8 are equal. Since the lengths of the two independent structures 8 are different, the radiofrequency ablation electrode tips 9 are uniform. It is arranged at the head of each independent structure 8, so the ablation point can also be realized on different renal artery cross sections. As shown in Figure 23C, the lengths of the two independent structures 8a and 8b can also be equal and the internal structures are basically mirror-symmetrical, but the attachment position of the radiofrequency ablation electrode tip 9 is different. The radiofrequency ablation electrode tip 9a on the independent structure 8a Closer to the distal end of the independent structure 8, in this way it is possible to achieve ablation points on different renal artery cross-sections. FIG. 23 illustrates the design scheme by taking two independent structures 8 as an example, so it is not limited to the situation of two independent structures 8 , and is also applicable to the situation of more than two independent structures 8 . In addition, for the case where the technician needs the independent structure 8 to form other curved shapes, corresponding adjustments can be made to the blank part of the independent structure 8 in FIG. 23 .
对于部分独立结构8远端连接于消融段头端17而部分独立结构8相互分离的情况，可以将图19、图21所示意的独立结构8的设计方案进行融合，即远端连接于消融段头端17的独立结构8采用图19所示意的设计方案，而相互分离的独立结构8采用图21所示意的设计方案。For the situation where the distal end of some independent structures 8 is connected to the head end 17 of the ablation section and some independent structures 8 are separated from each other, the design schemes of the independent structures 8 shown in Figure 19 and Figure 21 can be integrated, that is, the distal end is connected to the ablation section The independent structure 8 of the head end 17 adopts the design scheme shown in FIG. 19 , while the mutually separated independent structures 8 adopt the design scheme shown in FIG. 21 .
图20显示了本发明的实施例是如何通过调整可控弯曲段5的硬度分布使设计形变更易实现，其中图20B、图20C为可控弯曲段5放大后的侧视图。图20中可控弯曲段5上的空白部分应理解为可控弯曲段5间隔一定距离的结构硬度降低，这种硬度下降不仅可以通过改变结构设计的方式实现也可以通过改变材料硬度的方式实现，因此可以通过调整可控弯曲段5上空白部分的大小、形态、分部密度等改变可控弯曲段5的硬度分布使其更易弯曲成为所需要的形态。与图19所示意的独立结构8的设计方案类似，可控弯曲段5也优选采用鸡肋样结构；当采用图17所示的鸡肋样结构时，可控弯曲段5可采用图17A和图17B所示的设计方案，其中图20B中虚线cc1所示的横截面的截面形态优选为图17B所示；当采用图18所示的鸡肋样结构时，图20A、图20B、图20C中可控弯曲段5的空白部分应理解为可控弯曲段5管壁间隔一定距离的结构硬度下降，例如通过去掉金属丝网、改变金属丝网的密度等；若需要弯曲的方向与图20B箭头ao1所示的方向相反(即箭头ao2所示方向)，则可采用图20C所示的设计方式。若需要可控弯曲段5向两侧都比较容易弯曲，可采用图20D所示的设计方案，即优选在可控弯曲段5相对的两侧分别设置图17或/和图18所示意的鸡肋样结构；当采用图17所示意的鸡肋样结构时，其设计方式类似图17C所示，只是各区域的大小稍有调整(如图20D中间图所示)，由于可弯控曲段5两侧的整体硬度比较小，可控弯曲段5更容易向两侧弯曲；当采用图18所示意的鸡肋样结构时，图20D中可控弯曲段5的空白部分应理解为可控弯曲段5管壁间隔一定距离的结构硬度下降，例如通过去掉金属丝网、改变金属丝网的密度等。如图20D的左右两幅侧视图所示，两侧鸡肋样结构的排布不一定完全对称，可以有一定的错位。对于需要实现多向弯曲(大于等于3个方向)，可空弯曲段5可采用图17所示意的鸡肋样结构的扩展设计方案和图18D所示的鸡肋样结构来帮助多向弯曲的实现。此外对于技术人员需要可弯控曲段5形成其他弯曲形态的情况，可以对图20中可控弯曲段5的空白部分进行相应调整。FIG. 20 shows how the embodiment of the present invention facilitates design deformation by adjusting the hardness distribution of the controllable bending section 5 , wherein FIG. 20B and FIG. 20C are enlarged side views of the controllable bending section 5 . The blank part on the controllable bending section 5 in Fig. 20 should be understood as the decrease in the structural hardness of the controllable bending section 5 at a certain distance. This decrease in hardness can be realized not only by changing the structural design but also by changing the hardness of the material. Therefore, the hardness distribution of the controllable bending section 5 can be changed by adjusting the size, shape, and subdivision density of the blank part on the controllable bending section 5 to make it easier to bend into a desired shape. Similar to the design scheme of the independent structure 8 shown in Figure 19, the controllable bending section 5 is also preferably a chicken-rib-like structure; when the chicken-rib-like structure shown in Figure 17 is adopted, the controllable bending section 5 can adopt Figure 17A and Figure 17B As shown in the design scheme, the cross-sectional form of the cross-section shown by the dotted line cc1 in Fig. 20B is preferably as shown in Fig. 17B; when the chicken rib-like structure shown in Fig. 18 is adopted, the controllable The blank part of the bending section 5 should be understood as the controllable bending section 5 with a certain distance between the pipe wall and the decrease in structural hardness, for example, by removing the wire mesh, changing the density of the wire mesh, etc.; If the direction shown is opposite (that is, the direction shown by arrow ao2), the design method shown in FIG. 20C can be adopted. If it is required that the controllable bending section 5 is relatively easy to bend to both sides, the design scheme shown in Fig. 20D can be adopted, that is, the chicken ribs shown in Fig. 17 or/and Fig. 18 are preferably respectively arranged on the opposite sides of the controllable bending section 5 When adopting the chicken-rib-like structure shown in Figure 17, its design method is similar to that shown in Figure 17C, except that the size of each area is slightly adjusted (as shown in the middle figure of Figure 20D). The overall hardness of the side is relatively small, and the controllable bending section 5 is easier to bend to both sides; when the chicken rib-like structure shown in Figure 18 is adopted, the blank part of the controllable bending section 5 in Figure 20D should be understood as the controllable bending section 5 The rigidity of the structure at a certain distance from the pipe wall is reduced, for example, by removing the wire mesh, changing the density of the wire mesh, etc. As shown in the left and right side views of Fig. 20D, the arrangement of chicken rib-like structures on both sides is not necessarily completely symmetrical, and there may be some misalignment. For multi-directional bending (greater than or equal to 3 directions), the empty bending section 5 can adopt the extended design scheme of the chicken-rib-like structure shown in FIG. 17 and the chicken-rib-like structure shown in FIG. 18D to help realize multi-directional bending. In addition, for the situation where the technician needs the bendable and controllable bending section 5 to form other bending shapes, the blank part of the controllable bending section 5 in FIG. 20 can be adjusted accordingly.
此外，图19、图20、图21、图22、图23所示意的空白部分除了有助于消融导管1形成设计形变的作用外，还能够缓冲消融导管1对血管的压力，起到保护血管的作用。In addition, the blank parts shown in Fig. 19, Fig. 20, Fig. 21, Fig. 22, and Fig. 23 not only contribute to the design deformation of the ablation catheter 1, but also can buffer the pressure of the ablation catheter 1 on the blood vessel and protect the blood vessel. role.
图24显示了本发明的实施例中导引导管7尾部的主要结构特点。如图24A所示，根据实际需要，导引导管7的末端(尾端、近端)可设有开孔77，开孔77与一段导管20连接后与注射器或注液装置相连，因此可通过开孔77行血管内注药或注射血管内造影剂，开孔77不使用时导管20是封闭的。如图24所示，导引导管7的尾部最好有密封设计，例如密封圈或密封套79，防止血液经导引导管7漏出和防止经导引导管7向血管内注射的药物或注射的造影剂漏出，其中图24A、图24B显示的是没有插入消融导管1的情况，图24C显示的是插入消融导管1的情况，图24B、图24C为导引导管7尾部的放大图；如图24所示，此外导引导管7的尾部周围最好有加固套78，使导引导管7尾部不易形变，便于操作，同时也方便与其他结构进行连接或贴附在其他结构上。导引导管7本身也可以在线控结构控制下发生形变，同时也可设置预制形变。如图24A所示，对于导引导管7仅有预制形变的情况，优选不设置导引导管控制柄27，其末端可仅设置连接接头71，连接接头71可与注射器、注液装置、消融导管1等连接。图25显示了本发明的实施例中导引导管7线控结构设计的主要结构特点以及如何通过调整导引导管7的硬度分布促进导引导管7形成所需要形变形态。在导引导管7的线控结构设中，优选以增加导向丝70张力(即牵拉导向丝70或前送导引导管7除导向丝70外的其他部分)的方式对导引导管7进行控制，当然技术人员也可以根据情况以增加导向丝70应力(即推送导向丝70或回退导引导管7除导向丝70外的其他部分)的方式对导引导管7进行控制。如图25A所示，在导引导管7的一侧管壁中设有导向丝70，当增加导向丝70的张力时，导引导管7将向设置导向丝70的一侧发生弯曲，也即图中箭头ao1所示方向，如果导引导管7需要实现多向控制弯曲可在导引导管7的几个方向上分别设置导向丝70。为了方便导引导管7形成需要的形变形态，可以改变导引导管7小段的硬度分布，这种硬度分布的改变不仅可以通过改变结构设计的方式实现也可以通过改变材料硬度的方式实现；图25B、图25C是以改变导引导管7小段的结构设计为例进行说明的，图25B、图25C中导引导管7管壁的空白部分代表管壁结构硬度减低的部分，对于通过改变导引导管7小段的材料硬度的方式，只需要将图25B、图25C中导引导管7管壁的空白部分用较软的材料进行制造。如图25B、图25C所示，导引导管7可采用鸡肋样结构，并优选采用图25所示的鸡肋样结构的设计方案；如图25B所示，当需要加强导引导管7向箭头ao1所示方向弯曲时，可将箭头ao1侧的导引导管7管壁中加强管壁硬度的设计结构削弱，例如可间隔一定距离将箭头ao1侧导引导管7管壁中的金属丝去掉，当增加导向丝70的张力时，导引导管7将更容易向箭头ao1方向弯曲；如图25C所示，对于线控双向弯曲的情况，可将导引导管7两侧管壁中加强管壁硬度的设计结构削弱，例如，可间隔一定距离将箭头ao2和箭头ao3侧导引导管7管壁中的金属丝去掉；对于多向控制弯曲的鸡肋样结构可以参考图25的设计方案。另外，导引导管7头部也可以先制成向某个方向的弯曲形态，这样在导引导管7不具有线控结构控制形变时，也可帮助导引导管7到达肾动脉，若在导引导管7具有线控结构控制其形变时，导引导管7的预制弯曲状态还能够增加导引导管7的控制弯曲方向，例如将导引导管7的线控结构控制形变的弯曲方向设置成与预置形变弯曲方向相反，这样就可以控制两个方向的弯曲。导向丝70在导引导管7管壁中的走行路径根据导引导管7的形变形态而定，一般与导引导管7长轴中性线平行；导向丝70可连接到导引导管7尾端独立的导引导管控制柄27上，该导引导管控制柄27可以与控制手柄2相连接或独立存在，导引导管7内的导向丝70也可以直接连接到控制手柄2，由控制手柄2控制(后述)。对于导引导管7的磁控结构设计，优选将永磁体、电磁铁或其他能够被磁铁吸引的物质设置在导引导管7头部及其附近位置的管壁中，通过外加磁场方向的改变能够控制导引导管7多个方向的弯曲。对于采用磁控结构设计的导引导管7也可以通过调整导引导管7的结构设计和导引导管7小段的制造材料的硬度进而改变导引导管7的硬度分布使设计的形变更易实现。当然技术人员可以根据实际需要，调整永磁体、电磁铁或其他能够被磁铁吸引的物质在导引导管7上的设置位置，使导引导管7形成其他形状的形变。Fig. 24 shows the main structural features of the tail of the guiding catheter 7 in the embodiment of the present invention. As shown in Figure 24A, according to actual needs, the end (tail end, proximal end) of the guide catheter 7 can be provided with an opening 77, and the opening 77 is connected to a section of catheter 20 and then connected to a syringe or an injection device, so it can be passed through The opening 77 is used for intravascular drug injection or intravascular contrast agent injection, and the catheter 20 is closed when the opening 77 is not in use. As shown in Figure 24, the tail of the guiding catheter 7 preferably has a sealing design, such as a sealing ring or a sealing sleeve 79, to prevent blood from leaking through the guiding catheter 7 and to prevent the drug or injected drug from the guiding catheter 7 into the blood vessel. Contrast agent leakage, where Fig. 24A and Fig. 24B show the situation where the ablation catheter 1 is not inserted, Fig. 24C shows the situation where the ablation catheter 1 is inserted, and Fig. 24B and Fig. 24C are enlarged views of the tail of the guiding catheter 7; As shown in 24, in addition, there is preferably a reinforcement sleeve 78 around the tail of the guiding catheter 7, so that the tail of the guiding catheter 7 is not easy to deform, easy to operate, and also convenient to connect with or attach to other structures. The guiding catheter 7 itself can also be deformed under the control of the wire-controlled structure, and prefabricated deformation can also be set at the same time. As shown in Figure 24A, for the situation where the guiding catheter 7 only has prefabricated deformation, it is preferable not to set the guiding catheter control handle 27, and only a connecting joint 71 can be provided at its end, and the connecting joint 71 can be connected with a syringe, a liquid injection device, and an ablation catheter. 1 and so on. FIG. 25 shows the main structural features of the wire-controlled structure design of the guide catheter 7 in the embodiment of the present invention and how to promote the formation of the required deformation shape of the guide catheter 7 by adjusting the hardness distribution of the guide catheter 7 . In the configuration of the wire control structure of the guide catheter 7, it is preferable to increase the tension of the guide wire 70 (that is, pull the guide wire 70 or advance the guide wire 7 except for the other parts of the guide wire 70) to guide the guide catheter 7. Control, of course, the technician can also control the guide catheter 7 by increasing the stress of the guide wire 70 (that is, pushing the guide wire 70 or retreating other parts of the guide catheter 7 except the guide wire 70) according to the situation. As shown in Figure 25A, a guide wire 70 is provided in one side of the guide catheter 7. When the tension of the guide wire 70 is increased, the guide catheter 7 will bend to the side where the guide wire 70 is installed, that is, In the direction indicated by the arrow ao1 in the figure, if the guiding catheter 7 needs to realize multi-directional controlled bending, guide wires 70 can be respectively arranged in several directions of the guiding catheter 7 . In order to facilitate the formation of the desired deformation form of the guiding catheter 7, the hardness distribution of the small section of the guiding catheter 7 can be changed. This change in hardness distribution can be realized not only by changing the structural design but also by changing the hardness of the material; FIG. 25B , Figure 25C is an example of changing the structural design of the guide catheter 7 sections, the blank part of the guide catheter 7 wall in Figure 25B and Figure 25C represents the part where the hardness of the tube wall structure is reduced. The mode of the material hardness of 7 subsections only needs to manufacture the blank part of the tube wall of the guiding catheter 7 in Fig. 25B and Fig. 25C with a softer material. As shown in Figure 25B and Figure 25C, the guiding catheter 7 can adopt a chicken rib-like structure, and preferably adopt the chicken rib-like structure design shown in Figure 25; as shown in Figure 25B, when it is necessary to strengthen the guiding catheter 7 to the arrow ao1 When bending in the direction shown, the design structure to strengthen the hardness of the tube wall in the guide tube 7 on the side of the arrow ao1 can be weakened. For example, the metal wire in the tube wall of the guide tube 7 on the side of the arrow ao1 can be removed at a certain distance. When the tension of the guide wire 70 is increased, the guide catheter 7 will bend more easily in the direction of the arrow ao1; as shown in Figure 25C, for the case of wire-controlled bidirectional bending, the hardness of the tube wall on both sides of the guide catheter 7 can be strengthened For example, the metal wires in the side guide tube 7 of arrows ao2 and arrow ao3 can be removed at a certain distance; for the chicken rib-like structure with multi-directional control bending, reference can be made to the design scheme in Figure 25. In addition, the head of the guide catheter 7 can also be made into a curved shape in a certain direction, so that when the guide catheter 7 does not have a wire-controlled structure to control deformation, it can also help the guide catheter 7 reach the renal artery. When the guide tube 7 has a control-by-wire structure to control its deformation, the prefabricated bending state of the guide tube 7 can also increase the control bending direction of the guide tube 7, for example, the bending direction of the control-by-wire structure of the guide tube 7 is set to be the same as The preset deformations bend in opposite directions so that you can control bending in both directions. The walking path of the guide wire 70 in the tube wall of the guide catheter 7 depends on the deformation form of the guide catheter 7, and is generally parallel to the neutral line of the long axis of the guide catheter 7; the guide wire 70 can be connected to the tail end of the guide catheter 7 On the independent guide catheter control handle 27, the guide catheter control handle 27 can be connected with the control handle 2 or exist independently, and the guide wire 70 in the guide catheter 7 can also be directly connected to the control handle 2, controlled by the control handle 2 Control (described later). For the design of the magnetic control structure of the guiding catheter 7, preferably permanent magnets, electromagnets or other materials that can be attracted by magnets are arranged in the tube wall of the guiding catheter 7 head and its vicinity, and the change of the direction of the applied magnetic field can Control the bending of the guiding catheter 7 in multiple directions. For the guiding catheter 7 adopting the magnetic control structure design, it is also possible to change the hardness distribution of the guiding catheter 7 by adjusting the structural design of the guiding catheter 7 and the hardness of the manufacturing material of the small section of the guiding catheter 7 to make the deformation of the design easier to realize. Of course, technicians can adjust the position of permanent magnets, electromagnets or other substances that can be attracted by magnets on the guide tube 7 according to actual needs, so that the guide tube 7 can be deformed in other shapes.
所述的消融导管1和导引导管7外表面可以标记显影刻度，以指示消融导管1和导引导管7进入血管的深度以及方便在超声、X射线等影像设备下间接测量人体结构的长度、宽度等。消融导管1和导引导管7上还可设置不同的显影标记用于在超声、X射线等影像设备下区分不同的导管。各独立结构8上优选设置不同的显影标记用于在超声、X射线等影像设备下区分不同的独立结构8，例如在一条独立结构8上标三角形，而另一条独立结构8标正方形，或在一条独立结构8上标三条带，而另一条独立结构8标两条带。此外消融导管1和导引导管7上还可设置显影标记用于在超声、X射线等影像设备下区分不同的轴向旋转状态，例如在消融导管1的左侧面设置一条在超声、X射线等影像设备下能够显影的短线，在消融导管1的右侧面设置另一条在超声、X射线等影像设备下能够显影的短线，当消融导管1处于水平位置时两条短线重合，当消融导管1轴向旋转一定角度时，短线则分开一定距离。为了降低消融导管1和导引导管7对血管造成损伤的可能性，优选地，消融导管1和导引导管7与血管壁接触的地方最好尽量光滑，同时形态最好尽量的圆滑，此外消融导管1和导引导管7的头部最好比较软。The outer surface of the ablation catheter 1 and the guide catheter 7 can be marked with a development scale to indicate the depth of the ablation catheter 1 and the guide catheter 7 entering the blood vessel and to facilitate the indirect measurement of the length of the human body structure under ultrasound, X-ray and other imaging equipment. width etc. The ablation catheter 1 and the guide catheter 7 can also be provided with different imaging marks for distinguishing different catheters under imaging equipment such as ultrasound and X-ray. Different development marks are preferably set on each independent structure 8 for distinguishing different independent structures 8 under imaging equipment such as ultrasound and X-ray, for example, a triangle is marked on one independent structure 8, and a square is marked on the other independent structure 8, or One independent structure 8 is marked with three bands, while the other independent structure 8 is marked with two bands. In addition, the ablation catheter 1 and the guiding catheter 7 can also be provided with visual markers to distinguish different axial rotation states under ultrasound, X-ray and other imaging equipment. For a short line that can be visualized under other imaging equipment, set another short line that can be visualized under ultrasound, X-ray and other imaging equipment on the right side of the ablation catheter 1. When the ablation catheter 1 is in a horizontal position, the two short lines overlap. When the ablation catheter 1 When the axis rotates at a certain angle, the short lines are separated by a certain distance. In order to reduce the possibility of damage to blood vessels caused by the ablation catheter 1 and the guide catheter 7, preferably, the place where the ablation catheter 1 and the guide catheter 7 are in contact with the blood vessel wall should be as smooth as possible, and the shape should be as smooth as possible. The head of catheter 1 and guide catheter 7 is preferably relatively soft.
消融导管1和导引导管7中可能直接或间接与人体体液或组织接触的部分都必须达到相应的与人体体液或组织接触材料的国家标准，对于不能达到上述要求又可能直接或间接与人体体液或组织接触的消融导管1和导引导管7的部分，其外面必须用符合与人体体液或组织相接触材料的国家标准的材料包裹。消融导管1和导引导管7可能与人体直接或间接接触部分的制造材料应能够耐受至少一种医用消毒方法。消融导管1和导引导管7可能与人体直接或间接接触的部分应该是绝缘的，对于不能达到绝缘要求的地方可以外包裹绝缘材料。The parts of the ablation catheter 1 and the guide catheter 7 that may directly or indirectly contact with human body fluids or tissues must meet the corresponding national standards for materials that are in contact with human body fluids or tissues. Or the parts of the ablation catheter 1 and the guide catheter 7 that are in contact with tissues must be wrapped with materials that meet the national standards for materials that are in contact with human body fluids or tissues. The manufacturing materials of the parts of the ablation catheter 1 and the guide catheter 7 that may be in direct or indirect contact with the human body should be able to withstand at least one medical disinfection method. The parts of the ablation catheter 1 and the guide catheter 7 that may be in direct or indirect contact with the human body should be insulated, and insulating materials can be wrapped around the parts that cannot meet the insulation requirements.
上述可控弯曲段5的作用在导管体段4不设置可控弯曲段5时，可以由导管体段4代为行使，只需要将上述可控弯曲段5的设计方案运用于导管体段4即可。The function of the above-mentioned controllable bending section 5 can be performed by the catheter body section 4 when the catheter body section 4 is not provided with the controllable bending section 5. It is only necessary to apply the design scheme of the above-mentioned controllable bending section 5 to the catheter body section 4. Can.
技术人员可以根据实际要求对上述这些消融导管1和导引导管7的设计方案进行融合、改进以及交叉使用，这些等效变化和修饰同样落入本发明的实施例权利要求所限定的范围。Technicians can fuse, improve and cross-use the above design schemes of the ablation catheter 1 and guide catheter 7 according to actual requirements, and these equivalent changes and modifications also fall within the scope defined by the claims of the embodiments of the present invention.
对于导引导管7连接于控制手柄2由控制手柄2负责控制的情况，控制手柄2可以同时控制导引导管7和消融导管1。根据导引导管7可以被控制的弯曲方向数量和可以被控制的弯曲方式，控制手柄2的设计略有不同。由于一般采用线控结构对导引导管7的形变进行控制，因此控制手柄2的设计是以线控结构为基础的，对于导引导管7形变的其他控制方式，只需要在线控结构控制手柄2的基础上稍加改进。图26、图27、图28均是以线控结构为例，显示了控制手柄2的主要结构特点。图26A、图26C、图27所示意的设计方案中，导引导管7与控制手柄2稳定相连，由控制手柄2负责控制；图26B所示意的设计方案中，导引导管7通过末端的连接接头71与消融导管1尾部连接，需要的时候，导引导管7又能够与消融导管1末端分离；图28所示意的设计方案中，导引导管7与导引导管控制柄27相连，由导引导管控制柄27负责控制。图26、图27、图28中虚线ac代表控制手柄2内的导线、细导管、光纤。For the situation that the guide catheter 7 is connected to the control handle 2 and controlled by the control handle 2, the control handle 2 can control the guide catheter 7 and the ablation catheter 1 at the same time. The design of the control handle 2 is slightly different according to the number of bendable directions and the controlled bendable manners of the guide catheter 7 . Since the wire control structure is generally used to control the deformation of the guide catheter 7, the design of the control handle 2 is based on the wire control structure. For other control methods for the deformation of the guide catheter 7, only the wire control structure control handle 2 is required. slightly improved on the basis of . Fig. 26, Fig. 27 and Fig. 28 all take the wire control structure as an example, showing the main structural features of the control handle 2. In the design scheme shown in Figure 26A, Figure 26C, and Figure 27, the guide catheter 7 is stably connected to the control handle 2, and the control handle 2 is responsible for controlling it; in the design scheme shown in Figure 26B, the guide catheter 7 is connected through the terminal The joint 71 is connected to the tail of the ablation catheter 1, and when necessary, the guide catheter 7 can be separated from the end of the ablation catheter 1; Guide tube control handle 27 is responsible for control. Dotted lines ac represent wires, thin conduits and optical fibers in the control handle 2 among Fig. 26, Fig. 27 and Fig. 28.
图26显示了本发明的实施例中不能通过线控结构控制导引导管7弯曲方向的情况下，控制手柄2的主要结构特点。图26A、图26C显示了导引导管7与控制手柄2稳定相连情况下，控制手柄2的主要结构特点，图26B显示了导引导管7通过末端的连接接头71与消融导管1尾部连接的情况下，控制手柄2的主要结构特点，其中图26C为图26A中虚线cc横截面放大的截面示意图。如图26A所示，控制手柄2优选设计成图示形状，主要由操作柄271和操作柄226组成，其中操作柄271一般位于控制手柄2的前部，主要负责控制导引导管7，而操作柄226一般位于控制手柄2的后部，主要负责控制消融导管1；操作柄271与导引导管7末端相连，操作柄271和操作柄226通过图中虚线矩形框ar标示的槽齿滑动结构进行连接，槽齿滑动结构由操作柄271尾部的环形钩状结构272和操作柄226头部的环形钩状结构240相互吻合组成，且连接后能够进行相对转动。如图26A、图26C所示，消融导管1与横截面成辐射状展开的连接杆251相连，连接杆251与环形控制钮250相连，推送(如图26B示)或回退环形控制钮250即可实现消融导管1的前进或回退，由于控制钮250成环状，因此即使旋转操作柄226仍不影响通过环形控制钮250控制消融导管1。图26C显示了图26A虚线cc横截面放大的截面示意图，有助于进一步说明连接杆251、环形控制钮250、操作柄226的空间结构关系。如图26C所示，消融导管1与横截面成辐射状展开的连接杆251相连，连接杆251穿过操作柄226上的一段开槽244与环形控制钮250，由于开槽244能限制连接杆251的转动，因此转动环形控制钮250和操作柄226的任意一个都能实现两者一起转动，进而实现消融导管1的转动；当然开槽244的长度即为消融导管1能够移动的距离，该长度一般小于环形控制钮250的宽度，这样环形控制钮250能够覆盖开槽244，环形控制钮250滑动时也不至于显露控制手柄2的内部结构；连接杆251和开槽244的数量不一定为四个，可以根据实际需要进行调整。如图26A所示，在操作柄226的尾部优选设有能量交换接头201，能量交换接头201通过缆线23(内含导线、光纤或细导管等，图1示)与消融发生装置部分3相连，主要负责接收由消融发生装置3传来的能量并将该能量通过控制手柄2内的导线、细导管、光纤ac等传输至消融头9、消融导管1上其他需要能量供应的部分、导引导管7上需要能量供应的部分及控制手柄2上需要能量供应的部分，同时能量交换接头201还兼具有传递消融导管1、导引导管7和控制手柄2上的传感器信号以及接收消融发生装置3传来的指令并将其传给消融导管1、导引导管7和控制手柄2的作用。如图26A所示，操作柄226的末端与能量交换接头201邻近的位置根据情况可设置液体灌注接头202，液体灌注接头202与消融导管1内的细导管相连，用于向消融导管1提供冷却液、造影剂等，液体灌注接头202在控制手柄2外通过导管与液体灌注器203相连，该液体灌注器203可以设置在消融发生装置部分3上，受消融发生装置部分3的控制，也可以是独立于消融发生装置部分3的系统，同时该液体灌注器203可以是手动进行液体灌注，也可以是自动进行液体灌注。此外在操作柄226的外表面和环形控制钮250的外表面可标示消融导管1推送距离及推送方向，在环形钩状结构272的外表面和操作柄226的外表面可标示操作柄271和操作柄226相对旋转角度及旋转方向。如图26B所示，整个控制手柄2主要由操作柄217组成，导引导管7将不与控制手柄2相连，消融导管1末端将与操作柄217的头端相连，在消融导管1的近端设有加固套48，以使消融导管1与控制手柄2连接的地方不易形变，便于操作。如图26B所示，导引导管7通过末端的连接接头71与消融导管1尾部相连，消融导管1尾部的加固套48有助于消融导管1与连接接头71相连，导引导管7内的密封圈或密封套79能够防止血液经导引导管7漏出和防止经导引导管7向血管内注射的药物或注射的造影剂漏出；对消融导管1的控制将主要通过前送或回退操作柄217以及旋转操作柄217。如图26B所示，类似地，在操作柄217的尾部优选设有能量交换接头201，根据情况能量交换接头201的旁边可设置液体灌注接头202。Fig. 26 shows the main structural features of the control handle 2 when the bending direction of the guiding catheter 7 cannot be controlled by the wire control structure in the embodiment of the present invention. Figure 26A and Figure 26C show the main structural features of the control handle 2 when the guide catheter 7 is stably connected to the control handle 2, and Figure 26B shows the situation where the guide catheter 7 is connected to the tail of the ablation catheter 1 through the connecting joint 71 at the end Next, the main structural features of the control handle 2, wherein FIG. 26C is an enlarged cross-sectional schematic diagram of the dotted line cc in FIG. 26A. As shown in Figure 26A, the control handle 2 is preferably designed in the shape shown in the figure, mainly composed of an operating handle 271 and an operating handle 226, wherein the operating handle 271 is generally located at the front of the control handle 2, and is mainly responsible for controlling the guide catheter 7, while operating The handle 226 is generally located at the rear of the control handle 2, and is mainly responsible for controlling the ablation catheter 1; the operating handle 271 is connected to the end of the guiding catheter 7, and the operating handle 271 and the operating handle 226 are carried out through the slotted sliding structure marked by the dotted rectangular frame ar in the figure. Connected, the slot tooth sliding structure is composed of the ring-shaped hook structure 272 at the tail of the handle 271 and the ring-shaped hook structure 240 at the head of the handle 226, which can be rotated relative to each other after being connected. As shown in Fig. 26A and Fig. 26C, the ablation catheter 1 is connected to the connecting rod 251 whose cross-section is radially expanded, and the connecting rod 251 is connected to the ring control button 250, and the push (as shown in Fig. 26B ) or retraction of the ring control button 250 is The ablation catheter 1 can be moved forward or backward. Since the control knob 250 is in the shape of a ring, the control of the ablation catheter 1 through the ring control button 250 will not be affected even if the operating handle 226 is rotated. FIG. 26C shows an enlarged schematic cross-sectional view of the dotted line cc in FIG. 26A , which helps to further illustrate the spatial structural relationship of the connecting rod 251 , the ring control knob 250 , and the operating handle 226 . As shown in Fig. 26C, the ablation catheter 1 is connected with a connecting rod 251 whose cross-section expands radially, and the connecting rod 251 passes through a section of slot 244 on the operating handle 226 and the annular control button 250, because the slot 244 can limit the connecting rod. 251, so turning any one of the ring control knob 250 and the operating handle 226 can realize the rotation of the two together, and then realize the rotation of the ablation catheter 1; of course, the length of the slot 244 is the distance that the ablation catheter 1 can move. The length is generally less than the width of the ring control button 250, so that the ring control button 250 can cover the slot 244, and the inner structure of the control handle 2 will not be exposed when the ring control button 250 slides; the number of the connecting rod 251 and the slot 244 is not necessarily Four, can be adjusted according to actual needs. As shown in Figure 26A, an energy exchange joint 201 is preferably provided at the tail of the operating handle 226, and the energy exchange joint 201 is connected to the part 3 of the ablation generating device through a cable 23 (including wires, optical fibers or thin catheters, etc., shown in Figure 1 ). , is mainly responsible for receiving the energy transmitted from the ablation generating device 3 and transmitting the energy to the ablation head 9, other parts on the ablation catheter 1 that require energy supply, and guidance through the wires, thin catheters, optical fibers ac, etc. in the control handle 2 The part on the catheter 7 that needs energy supply and the part on the control handle 2 that needs energy supply, at the same time, the energy exchange joint 201 also has the function of transmitting the sensor signals on the ablation catheter 1, the guide catheter 7 and the control handle 2 and receiving the ablation generating device 3 and pass it on to the ablation catheter 1, the guide catheter 7 and the control handle 2. As shown in FIG. 26A , the position adjacent to the end of the operating handle 226 and the energy exchange joint 201 can be provided with a liquid infusion joint 202 according to the situation, and the liquid infusion joint 202 is connected with the thin catheter in the ablation catheter 1 to provide cooling for the ablation catheter 1 liquid, contrast agent, etc., the liquid perfusion joint 202 is connected to the liquid perfusion device 203 through a catheter outside the control handle 2, and the liquid perfusion device 203 can be set on the ablation generating device part 3, controlled by the ablation generating device part 3, or can be It is a system independent of the part 3 of the ablation generating device, and the liquid injector 203 can perform liquid injection manually or automatically. In addition, the pushing distance and pushing direction of the ablation catheter 1 can be marked on the outer surface of the operating handle 226 and the outer surface of the ring control button 250, and the operating handle 271 and the operating The handle 226 is relative to the rotation angle and rotation direction. As shown in Figure 26B, the entire control handle 2 is mainly composed of an operating handle 217. The guide catheter 7 will not be connected to the control handle 2, and the end of the ablation catheter 1 will be connected to the head end of the operating handle 217. A reinforcement sleeve 48 is provided so that the place where the ablation catheter 1 is connected to the control handle 2 is not easily deformed and is easy to operate. As shown in Figure 26B, the guide catheter 7 is connected to the tail of the ablation catheter 1 through the connecting joint 71 at the end, and the reinforcement sleeve 48 at the tail of the ablation catheter 1 helps the ablation catheter 1 to be connected to the connecting joint 71. The ring or sealing sleeve 79 can prevent the leakage of blood through the guide catheter 7 and the leakage of the medicine or injected contrast agent injected into the blood vessel through the guide catheter 7; 217 and rotating handle 217. As shown in FIG. 26B , similarly, an energy exchange joint 201 is preferably provided at the tail of the operating handle 217 , and a liquid injection joint 202 may be provided next to the energy exchange joint 201 according to circumstances.
图27显示了本发明的实施例中能够通过线控结构控制导引导管7弯曲方向的控制手柄2的主要结构特点；其中图27A、图27B显示了控制手柄2能够控制导引导管7向一个方向弯曲情况下控制手柄2的主要结构特点，图27C、图27D显示了控制手柄2能够控制导引导管7向两个方向弯曲情况下控制手柄2的主要结构特点，图27E、图27F是以四根导向丝70的情况为例，显示了控制手柄2能够控制导引导管7向多个方向(≥3方向)弯曲情况下控制手柄2的主要结构特点；由于图27中操作柄226的设计方案与图26A、图26C中操作柄226的设计方案相同，因此图27主要显示了操作柄271的结构特点，此外对于图27所示意的控制手柄2的设计方案与图26所示意的控制手柄2的设计方案相同的地方这里就不再复述。图27A、图27B显示了控制手柄2能够控制导引导管7向一个方向弯曲情况下，控制手柄2的主要结构特点，此时优选设置一根导向丝70；其中图27B为图27A中虚线cc1横截面放大的截面示意图。如图27A所示，导向丝70从导引导管7末端走行出后，经过操作柄271上的连接通道277与环绕操作柄271上类似环形的控制钮237相连，控制钮237可在操作柄271上滑动；当向箭头ao1方向推送控制钮237时，导向丝70将受到牵拉，通过这种方式能够控制导引导管7的弯曲方向。为了避免导向丝70受到过分牵拉导致导引导管7的弯曲伤及血管壁，可设置缓冲结构，即将走行在连接通道277内的导向丝70的中间一段用弹簧或具有弹力的细线代替，图27A是以设置弹簧282为例进行说明的，在弹簧282处的连接通道277直径稍粗以容纳弹簧282，当牵拉导向丝70时，弹簧282可以伸展，这样能够起到缓冲牵拉力的作用，同时由于弹簧282的直径略大于两边连接通道277的直径，因此弹簧282的伸展距离不会超过连接通道277膨大的部分，这就使得弹簧282到导引导管7头端的导向丝70的张力不至于超过弹簧282最大伸展距离下所产生的拉力，也就相当于设定了一个拉力限值。当然为了避免导向丝70受到过分牵拉导致导引导管7的弯曲伤及血管壁，还可以在导向丝70上连接张力传感器。此外，技术人员还可以根据实际需要通过调节导向丝70的初始张力、导向丝70在控制手柄2内的走行路径、连接通道277在操作柄271凹陷部分的开口大小等方式调控控制钮237控制导向丝70的敏感性。为了通过控制钮237的转动控制操作柄271的转动，可在控制钮237与操作柄271间设置槽齿滑动结构；如图27B所示，虚线小矩形框rc即为槽齿滑动结构所在的位置，虚线大矩形框内的图像显示了槽齿滑动结构的放大图，槽齿滑动结构由凹槽285和突出齿286组成，图27B是以凹槽285和突出齿286分别设置于控制钮237和操作柄271上为例进行说明的，根据具体情况也可将凹槽285和突出齿286分别设置于操作柄271和控制钮237上；当旋转控制钮237时，由于槽齿滑动结构的存在，将带动操作柄271一起转动，同时控制钮237前后滑动又不会受到影响；技术人员可以根据需要调整槽齿滑动结构的位置以及设置数量，只要保证控制钮237和操作柄271能一起转动且控制钮237的前后滑动不受影响。为方便操作，在操作柄271和控制钮237的外表面可标示控制钮237移动距离以及移动方向，在操作柄226的外表面、环形钩状结构272的外表面和控制钮237的外表面可标示操作柄271和操作柄226相对旋转角度及转动方向。图27C、图27D显示了控制手柄2能够控制导引导管7向两个方向弯曲情况下，控制手柄2的主要结构特点，其中图27D为图27C中虚线cc2横截面放大的截面示意图。如图27C所示，此时优选设置两根导向丝70a、70b，两根导向丝70a、70b将各控制导引导管7一个方向的弯曲，且分别经过连接通道277a、277b优选在相对的位置上与控制钮237相连，同样地也可设置弹簧282用于缓冲控制钮237对导向丝70的牵拉；控制钮237能够前后滑动，当控制钮237向箭头ao2方向滑动时，导向丝70b将受到牵拉，弹簧282b拉伸，而导向丝70a由于连接通道277a远端漏斗样槽278a的存在，其处于放松状态；当控制钮237向箭头ao3方向滑动时，导向丝70a将受到牵拉，弹簧282a拉伸，而导向丝70b由于连接通道277b远端漏斗样槽278b的存在，其处于放松状态。类似地，技术人员可以根据实际需要通过调节导向丝70的初始张力、导向丝70在控制手柄2内的走行路径、控制钮237突入操作柄271部分的位置、漏斗样槽278开口大小与设置位置等方式调控控制钮237控制两条导向丝70的敏感性，使得控制钮237在不同方向上离开初始位置相同距离的情况下两条导向丝70受到相同或不同大小力的牵拉。同样地，为了实现通过控制钮237的转动控制操作柄271的转动，图27C、图27D所示的设计方案也可采用图27B所示意的在控制钮237与操作柄271间设置槽齿滑动结构。若导引导管7有一个方向的预制弯曲形变，而导向丝70设置在另外一个方向以拮抗预制弯曲形变从而实现控制导引导管7两个相对方向的弯曲，在这种情况下需要从导向丝70a、70b中去掉一根，并去除相应的附属结构。同样地，在操作柄271和控制钮237的外表面可标示控制钮237移动距离以及移动方向，在操作柄226的外表面、环形钩状结构272的外表面和控制钮237的外表面可标示操作柄271和操作柄226相对旋转角度及转动方向。图27E、图27F是以四根导向丝70的情况为例，显示了控制手柄2能够控制导引导管7向多个方向(≥3方向)弯曲情况下控制手柄2的主要结构特点，其中图27F为图27E中虚线cc3横截面放大的截面示意图。如图27E所示，图27A、图27B、图27C、图27D中控制导向丝70的控制钮237由控制盘238代替，控制盘238没有突入操作柄271的部分，且操作柄271与控制盘238之间的接触面是球形万向关节的一部分，因此控制盘238能够向多个方向转动，且向前或向后推动控制盘238不会使其移动而滑出操作柄271。由于截面的原因图27E仅显示了两条导向丝70a、70c。如图27E、图27F所示，各控制可控弯曲段5一个方向弯曲的四根导向丝70a、70b、70c、70d将分别经过连接通道277a、277b、277c、277d与控制盘238相连，四根导向丝70优选地均匀分布于控制盘238和操作柄271的圆周上，同样地也可设置缓冲结构，例如设置弹簧282用于缓冲控制盘238对导向丝70的牵拉；当控制盘238向箭头ao4所示方向转动时，导向丝70c将受到牵拉，弹簧282c拉伸，而导向丝70b由于连接通道277b远端漏斗样槽278b的存在，其处于放松状态；当控制盘238向箭头ao5所示方向转动时，导向丝70a将受到牵拉，弹簧282a拉伸，而导向丝70c由于连接通道277c远端漏斗样槽278c的存在，其处于放松状态；如果控制盘238转动方向不在任何一条导向丝70上，此时将有两条相邻的导向丝70受到牵拉，这样导引导管7将向两条受到牵拉的导向丝70合力的方向弯曲，通过这样的方式即实现了控制导引导管7的多向弯曲。类似地，技术人员还可以根据实际需要通过调节导向丝70的初始张力、导向丝70在控制手柄2内的走行路径、漏斗样槽278开口大小与设置位置等方式调控控制盘238控制四条导向丝70的敏感性，使得控制盘238在四条导向丝70方向上离开初始位置相同距离的情况下四条导向丝70受到相同或不同大小力的牵拉。同样地，在操作柄271和控制盘238的外表面可标示控制盘238转动角度以及转动方向，在操作柄226的外表面、环形钩状结构272的外表面和控制盘238的外表面可标示操作柄271和操作柄226相对旋转角度及转动方向。图27E、图27F仅是以四根导向丝70为例进行结构说明的，图27E、图27F所示的设计方案还可以用于扩展用于导向丝70大于等于一根的情况。Fig. 27 shows the main structural features of the control handle 2 that can control the bending direction of the guiding catheter 7 through the wire control structure in the embodiment of the present invention; wherein Fig. 27A and Fig. 27B show that the control handle 2 can control the guiding catheter 7 to a The main structural features of the control handle 2 in the case of bending in two directions. Figure 27C and Figure 27D show the main structural features of the control handle 2 when the control handle 2 can control the guiding catheter 7 to bend in two directions. Figure 27E and Figure 27F are based on The situation of four guide wires 70 is an example, showing that the control handle 2 can control the main structural features of the control handle 2 under the situation that the guide catheter 7 is bent in multiple directions (≥3 directions); The scheme is the same as the design scheme of the handle 226 in Fig. 26A and Fig. 26C, so Fig. 27 mainly shows the structural features of the handle 271. In addition, the design scheme of the control handle 2 shown in Fig. 27 is the same as that of the control handle 2 shown in Fig. 26 Where the design scheme of 2 is the same, it will not be repeated here. Figures 27A and 27B show the main structural features of the control handle 2 when the control handle 2 can control the bending of the guiding catheter 7 in one direction. At this time, a guide wire 70 is preferably provided; where Figure 27B is the dotted line cc1 in Figure 27A Schematic cross-sectional view of enlarged cross-section. As shown in Figure 27A, after the guide wire 70 walks out from the end of the guiding catheter 7, it passes through the connecting channel 277 on the operating handle 271 and connects with the ring-like control button 237 surrounding the operating handle 271. The control button 237 can be placed on the operating handle 271 slide upward; when the control button 237 is pushed in the direction of the arrow ao1, the guide wire 70 will be pulled, and in this way the bending direction of the guiding catheter 7 can be controlled. In order to prevent the guide wire 70 from being overstretched and causing the bending of the guide catheter 7 to damage the blood vessel wall, a buffer structure can be provided, that is, the middle section of the guide wire 70 running in the connecting channel 277 is replaced by a spring or a thin wire with elastic force. Fig. 27A is illustrated by setting the spring 282 as an example. The diameter of the connecting channel 277 at the spring 282 is slightly thicker to accommodate the spring 282. When the guide wire 70 is pulled, the spring 282 can be stretched, which can buffer the pulling force. At the same time, because the diameter of the spring 282 is slightly larger than the diameter of the connecting channel 277 on both sides, the extension distance of the spring 282 will not exceed the enlarged part of the connecting channel 277, which makes the spring 282 reach the guide wire 70 at the head end of the guiding catheter 7. The tension will not exceed the tension generated by the maximum stretching distance of the spring 282, which is equivalent to setting a tension limit. Of course, in order to prevent the guide wire 70 from being excessively pulled and causing the bending of the guide catheter 7 to damage the blood vessel wall, a tension sensor can also be connected to the guide wire 70 . In addition, technicians can also adjust the control button 237 to control the guide according to actual needs by adjusting the initial tension of the guide wire 70, the walking path of the guide wire 70 in the control handle 2, and the opening size of the connecting channel 277 in the concave part of the handle 271. Silk 70 Sensitivity. In order to control the rotation of the operating handle 271 through the rotation of the control button 237, a slotted tooth sliding structure can be provided between the control button 237 and the operating handle 271; as shown in Figure 27B, the small rectangular frame rc with a dotted line is the position of the slotted tooth sliding structure , the image inside the large rectangle frame with dotted line shows the enlarged view of the sliding structure of the slotted teeth. The sliding structure of the slotted teeth is composed of grooves 285 and protruding teeth 286. In FIG. The operating handle 271 is used as an example for illustration, and the groove 285 and the protruding teeth 286 can also be respectively arranged on the operating handle 271 and the control knob 237 according to specific conditions; when the control knob 237 is rotated, due to the existence of the slot tooth sliding structure, It will drive the operating handle 271 to rotate together, and the front and rear sliding of the control button 237 will not be affected at the same time; technicians can adjust the position and setting quantity of the slotted sliding structure as required, as long as the control button 237 and the operating handle 271 can be rotated together and controlled. The back and forth sliding of button 237 is not affected. For the convenience of operation, the control button 237 moving distance and moving direction can be marked on the outer surface of the operating handle 271 and the control button 237, and can be marked on the outer surface of the operating handle 226, the outer surface of the annular hook structure 272 and the outer surface of the control button 237. The relative rotation angle and rotation direction of the operating handle 271 and the operating handle 226 are indicated. Figure 27C and Figure 27D show the main structural features of the control handle 2 when the control handle 2 can control the bending of the guiding catheter 7 in two directions. As shown in FIG. 27C, at this time, two guide wires 70a, 70b are preferably provided. The two guide wires 70a, 70b will control the bending of the guiding catheter 7 in one direction, and respectively pass through the connecting channels 277a, 277b, preferably at opposite positions. is connected to the control knob 237, and a spring 282 can also be set to buffer the pulling of the control knob 237 on the guide wire 70; the control knob 237 can slide back and forth, and when the control knob 237 slides in the direction of the arrow ao2, the guide wire 70b will Being pulled, the spring 282b is stretched, and the guide wire 70a is in a relaxed state due to the existence of the funnel-like groove 278a at the far end of the connecting channel 277a; when the control button 237 slides in the direction of the arrow ao3, the guide wire 70a will be pulled, The spring 282a is stretched, while the guide wire 70b is in a relaxed state due to the presence of the funnel-like groove 278b at the distal end of the connecting channel 277b. Similarly, the technician can adjust the initial tension of the guide wire 70, the walking path of the guide wire 70 in the control handle 2, the position where the control button 237 protrudes into the handle 271, the opening size and the setting position of the funnel-like groove 278 according to actual needs. The control button 237 is adjusted in an equal manner to control the sensitivity of the two guide wires 70, so that the two guide wires 70 are pulled by the same or different forces when the control button 237 is the same distance away from the initial position in different directions. Similarly, in order to control the rotation of the operating handle 271 through the rotation of the control button 237, the designs shown in Figure 27C and Figure 27D can also adopt the slotted sliding structure shown in Figure 27B between the control button 237 and the operating handle 271 . If the guiding catheter 7 has a prefabricated bending deformation in one direction, and the guide wire 70 is set in another direction to antagonize the prefabricated bending deformation so as to realize the control of the bending of the guiding catheter 7 in two opposite directions, in this case, it is necessary to obtain a guide wire Remove one of 70a, 70b, and remove the corresponding subsidiary structure. Similarly, the movement distance and direction of movement of the control knob 237 can be marked on the outer surfaces of the operating handle 271 and the control knob 237, and can be marked on the outer surface of the operating handle 226, the outer surface of the annular hook structure 272 and the outer surface of the control knob 237. The operating handle 271 and the operating handle 226 have a relative rotation angle and rotation direction. Fig. 27E and Fig. 27F take the case of four guide wires 70 as an example, showing the main structural features of the control handle 2 when the control handle 2 can control the bending of the guiding catheter 7 in multiple directions (≥ 3 directions). 27F is an enlarged schematic cross-sectional view of the dotted line cc3 in FIG. 27E. As shown in Figure 27E, the control knob 237 of the control guide wire 70 in Figure 27A, Figure 27B, Figure 27C, and Figure 27D is replaced by a control disc 238, and the control disc 238 does not protrude into the part of the operating handle 271, and the operating handle 271 and the control disc The contact surface between 238 is part of a spherical universal joint so that the control disc 238 can be turned in multiple directions and pushing the control disc 238 forward or backward will not cause it to move and slide out of the operating handle 271 . Figure 27E shows only two guidewires 70a, 70c for reasons of cross-section. As shown in Figure 27E and Figure 27F, the four guide wires 70a, 70b, 70c, and 70d bent in one direction by each controllable bending section 5 will be connected to the control panel 238 through the connecting channels 277a, 277b, 277c, and 277d respectively. The root guide wire 70 is preferably evenly distributed on the circumference of the control disc 238 and the operating handle 271, and a buffer structure can also be provided, such as setting a spring 282 for buffering the pull of the control disc 238 to the guide wire 70; when the control disc 238 When turning to the direction shown by arrow ao4, the guide wire 70c will be pulled, the spring 282c will stretch, and the guide wire 70b is in a relaxed state due to the existence of the funnel-like groove 278b at the far end of the connecting channel 277b; When rotating in the direction indicated by ao5, the guide wire 70a will be pulled, the spring 282a will be stretched, and the guide wire 70c will be in a relaxed state due to the existence of the funnel-like groove 278c at the far end of the connecting channel 277c; On one guide wire 70, at this time, two adjacent guide wires 70 will be pulled, so that the guiding catheter 7 will bend in the direction of the resultant force of the two pulled guide wires 70. In this way, the Multidirectional bending of the guide catheter 7 is controlled. Similarly, technicians can adjust the control panel 238 to control the four guide wires by adjusting the initial tension of the guide wire 70, the walking path of the guide wire 70 in the control handle 2, the opening size and setting position of the funnel-like groove 278, etc. according to actual needs. The sensitivity of 70 makes the four guide wires 70 be pulled by the same or different forces when the control disk 238 is the same distance away from the initial position in the direction of the four guide wires 70 . Similarly, the rotation angle and direction of rotation of the control disc 238 can be marked on the outer surfaces of the operating handle 271 and the control disc 238, and can be marked on the outer surface of the operating handle 226, the outer surface of the annular hook structure 272 and the outer surface of the control disc 238. The operating handle 271 and the operating handle 226 have a relative rotation angle and rotation direction. FIG. 27E and FIG. 27F only illustrate the structure by taking four guide wires 70 as an example. The design solutions shown in FIG. 27E and FIG. 27F can also be extended to the case where there is more than one guide wire 70 .
导引导管7也可直接与导引导管控制柄27相连，由导引导管控制柄27负责控制，此时优选导引导管控制柄27能够与控制消融导管1的控制手柄2接合和分拆，图28所示意的设计方案是以图26、图27所示意的设计方案为基础进行改进的，改进的设计方案主要对操作柄226进行了改进，因此对于图28所示意的导引导管控制柄27和控制手柄2的设计方案中与图26、图27所示意的设计方案一致的地方这里就不再赘述。图28是以导引导管控制柄27能够控制导引导管7向一个方向弯曲的情况下的导引导管控制柄27和控制手柄2的设计方案为例，说明了本发明如何实现将独立的导引导管控制柄27与控制手柄2相互接合和分拆，即实现既可分离使用也可接合使用；其中图28B是导引导管控制柄27的示意图，图28C是控制手柄2的示意图，图28A是两者接合在一起的示意图，图28D、图28E分别是图28A中虚线cc1、cc2横截面放大的截面示意图。如图28B所示，导引导管控制柄27主要由操作柄271'、操作柄273、控制钮237'组成，操作柄271'与操作柄273操作柄之间的转动可以通过图中虚线矩形框ar所示的由环形钩状结构272和环形钩状结构270相互吻合组成的槽齿滑动结构实现。如图28C所示，控制手柄2主要由操作柄241、环形控制钮250、连接杆251、能量交换接头201组成，操作柄241与环形控制钮250的一起转动的实现方式与图27中提及的方案相同，根据情况设置或不设置液体灌注接头202。当导引导管控制柄27与控制手柄2需要接合时，消融导管1将首先经导引导管控制柄27套入导引导管7，如图28A、图28B、图28C所示，导引导管控制柄27与控制手柄2的接合成为一个操控手柄主要依靠操作柄273和操作柄241上的可脱槽齿滑动结构，该可脱槽齿滑动结构由操作柄273上的卡槽293、锥柱体凹槽292、卡环297、卡孔299和操作柄241上的可压钩状结构242、锥柱体突出榫243组成。如图28A、图28B所示，接合时，将可压钩状结构242对卡槽293，将锥柱体突出榫243对准锥柱体凹槽292，然后推送操作柄241或回压导引导管控制柄27，由于可压钩状结构242头部的压扭294的斜面和卡环297靠操作柄241的斜面相对，可压钩状结构242将顺势进入进入卡槽293，锥柱体突出榫243也将进入锥柱体凹槽292，当操作柄273与操作柄241接近相接触时，可压钩状结构242将弹入由卡环297和操作柄273组成的卡孔299中，由于可压钩状结构242头部的压扭294和卡孔299的限制，导引导管控制柄27与控制手柄2的接合将十分稳定。如图28A、图28B所示，分离时，同时按压相对位置上的两个可压钩状结构242头部的压扭294使其退出卡孔299中，同时顺势推送导引导管控制柄27或回拉操作柄241，由于卡环297的斜面和可压钩状结构242头部的压扭294的斜面相对，压扭294将再次进入卡槽293，随着操作柄273和操作柄241的进一步远离，可压钩状结构242的头部压扭294将弹出卡槽293，同时锥柱体突出榫243也将退出锥柱体凹槽292，随后消融导管1退出导引导管7，完成分离。为了使可压钩状结构242能顺利进出卡槽293同时卡槽293又能限制可压钩状结构242的转动，如图28D所示，卡槽293的宽度优选与可压钩状结构242相近，并刚好能卡住可压钩状结构242，而卡槽293的高度优选大于压钮294的厚度。此外为了实现操作柄273和操作柄241的一起转动，如图28D、图28E所示，可在锥柱体突出榫243与操作柄273之间设置类似图28中虚线矩形框rc所示意的槽齿滑动结构；图28E中虚线大矩形内放大了该结构，其中优选将凹槽295设置在操作柄273上，将突出齿296设置在锥柱体突出榫243上，技术人员根据需要也可以将凹槽295设置在锥柱体突出榫243上，将突出齿296设置在操作柄273上；图28D、图28E中有四个槽齿滑动结构，技术人员根据需要可对其数量和分部进行调整。另外，可压钩状结构242优选设置为两个，技术人员根据需要可以进行调整。类似地，为方便操作导引导管控制柄27，可以在控制钮237'上、操作柄271'上标示控制钮237'的移动距离和移动方向，在控制钮237'上、操作柄271'上、操作柄273上标示操作柄271'与操作柄273相对旋转角度和旋转方向；为了方便导引导管控制柄27与控制手柄2接合，可以在导引导管控制柄27上与控制手柄2上分别标示两者接合的对位线、对位标志等。图28仅是以导引导管控制柄27能够控制导引导管7向一个方向弯曲的情况下的导引导管控制柄27与控制手柄2的设计方案为例进行说明的，对于导引导管7能够双向或多向控制弯曲的情况，只需要将图28中的操作柄271'替换成导引导管7能够双向或多向控制弯曲的情况下的操作柄271或操作柄213。此外可脱卡榫结构及设计思路还可扩展用于控制手柄2的其他设计方案和其他控制器的设计方案中。The guiding catheter 7 can also be directly connected to the guiding catheter control handle 27, and the guiding catheter control handle 27 is responsible for controlling it. At this time, it is preferable that the guiding catheter control handle 27 can be engaged and disassembled with the control handle 2 that controls the ablation catheter 1, The design scheme shown in Figure 28 is improved on the basis of the design schemes shown in Figure 26 and Figure 27, and the improved design scheme mainly improves the operating handle 226, so for the guide catheter control handle shown in Figure 28 27 and the design scheme of the control handle 2 are consistent with the design scheme shown in Figure 26 and Figure 27 and will not repeat them here. Figure 28 is an example of the design of the guide catheter control handle 27 and the control handle 2 under the condition that the guide catheter control handle 27 can control the guide catheter 7 to bend in one direction, illustrating how the present invention realizes the independent guide catheter The control handle 27 of the guide tube and the control handle 2 are mutually engaged and disassembled, that is, it can be used separately or in conjunction; FIG. 28B is a schematic diagram of the control handle 27 of the guide tube, FIG. 28C is a schematic diagram of the control handle 2, and FIG. 28A It is a schematic diagram of the joining together of the two, and FIG. 28D and FIG. 28E are respectively enlarged cross-sectional schematic diagrams of the dotted lines cc1 and cc2 in FIG. 28A . As shown in Figure 28B, the guiding catheter control handle 27 is mainly composed of an operating handle 271', an operating handle 273, and a control button 237'. The slot tooth sliding structure shown in ar is realized by the ring-shaped hook structure 272 and the ring-shaped hook structure 270 matching each other. As shown in Figure 28C, the control handle 2 is mainly composed of an operating handle 241, an annular control knob 250, a connecting rod 251, and an energy exchange joint 201. The scheme is the same, and the liquid perfusion joint 202 is set or not set according to the situation. When the guide catheter control handle 27 needs to be engaged with the control handle 2, the ablation catheter 1 will first be inserted into the guide catheter 7 through the guide catheter control handle 27, as shown in Figure 28A, Figure 28B, and Figure 28C, the guide catheter control The engagement of the handle 27 and the control handle 2 to become a control handle mainly depends on the sliding structure of the removable teeth on the operating handle 273 and the operating handle 241. The groove 292, the snap ring 297, the snap hole 299, the depressible hook structure 242 on the operating handle 241, and the protruding tenon 243 of the tapered cylinder are composed. As shown in Fig. 28A and Fig. 28B, when engaging, put the depressible hook structure 242 against the slot 293, align the protruding tenon 243 of the cone cylinder with the groove 292 of the cone cylinder, and then push the operating handle 241 or back pressure guide Catheter control handle 27, because the slope of the pressure twist 294 on the head of the depressible hook-shaped structure 242 is opposite to the slope of the handle 241 of the clasp 297, the depressible hook-shaped structure 242 will enter the card groove 293 along the way, and the cone and cylinder will protrude The tenon 243 will also enter the taper cylinder groove 292, and when the operating handle 273 is in close contact with the operating handle 241, the depressible hook-shaped structure 242 will spring into the clamping hole 299 formed by the snap ring 297 and the operating handle 273, because The pressure twist 294 on the head of the hook-like structure 242 and the limitation of the clamping hole 299 can make the engagement between the guide catheter control handle 27 and the control handle 2 very stable. As shown in Figure 28A and Figure 28B, when separating, simultaneously press the pressing knobs 294 on the heads of the two depressible hook-like structures 242 at opposite positions to make them withdraw from the clamping holes 299, and at the same time push the guiding catheter control handle 27 or Pull back the operating handle 241, because the inclined plane of the snap ring 297 is opposite to the inclined plane of the pressing twist 294 of the head of the depressible hook structure 242, the pressing twist 294 will enter the draw-in groove 293 again, along with the further movement of the operating handle 273 and the operating handle 241 Moving away, the head twist 294 of the depressible hook-like structure 242 will pop out of the slot 293, and the protruding tenon 243 of the cone cylinder will also exit the groove 292 of the cone cylinder, and then the ablation catheter 1 will exit the guide catheter 7 to complete the separation. In order to enable the depressible hook-shaped structure 242 to smoothly enter and exit the card slot 293 and at the same time the card slot 293 can limit the rotation of the depressible hook-shaped structure 242, as shown in FIG. , and just enough to hold the depressible hook structure 242 , and the height of the detent 293 is preferably greater than the thickness of the push button 294 . In addition, in order to realize the joint rotation of the operating handle 273 and the operating handle 241, as shown in Figure 28D and Figure 28E, a groove similar to that shown by the dotted rectangular frame rc in Figure 28 can be provided between the tapered cylinder protruding tenon 243 and the operating handle 273 Tooth sliding structure; the structure is enlarged in the big rectangle of the dotted line in Fig. 28E, wherein the groove 295 is preferably arranged on the operating handle 273, and the protruding tooth 296 is arranged on the protruding tenon 243 of the cone cylinder. The groove 295 is set on the protruding tenon 243 of the cone cylinder, and the protruding tooth 296 is set on the operating handle 273; there are four groove tooth sliding structures in Fig. 28D and Fig. 28E, and technicians can adjust the number and divisions according to their needs. Adjustment. In addition, two depressible hook-shaped structures 242 are preferably provided, and technicians can adjust them as needed. Similarly, in order to facilitate the operation of the guide catheter control handle 27, the moving distance and moving direction of the control button 237' can be marked on the control button 237' and the operating handle 271'; 1. On the operating handle 273, the relative rotation angle and direction of the operating handle 271' and the operating handle 273 are marked; in order to facilitate the joint of the guiding catheter control handle 27 and the control handle 2, the guiding catheter control handle 27 and the control handle 2 can be respectively Mark the alignment line, alignment mark, etc. where the two are joined. Figure 28 is only an example of the design of the guide catheter control handle 27 and the control handle 2 under the condition that the guide catheter control handle 27 can control the guide catheter 7 to bend in one direction. In the case of two-way or multi-directional control bending, it is only necessary to replace the operating handle 271' in FIG. In addition, the detachable tenon structure and design idea can also be extended and used in other design schemes of the control handle 2 and other controller design schemes.
若在导引导管控制柄27与控制手柄2融合设计成一个控制手柄2的情况下，需要用导丝引导导引导管7进入血管，优选不封闭导引导管7的头端开口，通过将导丝穿过导引导管7头端开口和导引导管7头部的斜孔74或侧槽76即可引导导引导管7进入血管，对于导引导管7头部的没有设置斜孔74或侧槽76的情况，可以在导引导管7的头部侧壁上设置一个类似图26B所示意的斜孔74，通过将导丝穿过导引导管7头端开口和头部侧壁上的斜孔74即可引导导引导管7进入血管。If the guide catheter control handle 27 is fused with the control handle 2 to form a control handle 2, it is necessary to use a guide wire to guide the guide catheter 7 into the blood vessel, preferably the head end opening of the guide catheter 7 is not closed, and the guide wire The wire passes through the opening of the head end of the guide catheter 7 and the inclined hole 74 or side groove 76 of the guide catheter 7 head to guide the guide catheter 7 to enter the blood vessel. In the case of the groove 76, a slanted hole 74 similar to that shown in FIG. The hole 74 can guide the guiding catheter 7 to enter the blood vessel.
上述这些控制手柄2和导引导管控制柄27的设计方案中控制手柄2和导引导管控制柄27的外形曲线优选方便人手的持握和控制。控制手柄2和导引导管控制柄27中可能直接或间接与人体体液或组织接触的部分都必须达到相应的与人体体液或组织接触材料的国家标准，对于不能达到上述要求又可能直接或间接与人体体液或组织接触的控制手柄2和导引导管控制柄27的部分，其外面必须用符合与人体体液或组织相接触材料的国家标准的材料包裹。控制手柄2和导引导管控制柄27可能与人体直接或间接接触部分的制造材料应能够耐受至少一种医用消毒方法。控制手柄2和导引导管控制柄27可能与人体直接或间接接触的部分应该是绝缘的，对于不能达到绝缘要求的地方可以外包裹绝缘材料。技术人员可以根据实际要求对上述这些控制手柄2和导引导管控制柄27的设计方案进行融合、改进以及交叉使用，这些等效变化和修饰同样落入本发明的实施例权利要求所限定的范围。In the design schemes of the above-mentioned control handle 2 and guide catheter control handle 27, the contour curves of the control handle 2 and guide catheter control handle 27 are preferably convenient for human hands to hold and control. The parts of the control handle 2 and the guide catheter control handle 27 that may directly or indirectly contact with human body fluids or tissues must meet the corresponding national standards for materials that are in contact with human body fluids or tissues. The parts of the control handle 2 and the guide catheter control handle 27 that are in contact with body fluids or tissues must be wrapped with materials that meet the national standards for materials that are in contact with body fluids or tissues. The manufacturing materials of the control handle 2 and the guide catheter control handle 27 that may be in direct or indirect contact with the human body should be able to withstand at least one medical disinfection method. The parts of the control handle 2 and the guide catheter control handle 27 that may be in direct or indirect contact with the human body should be insulated, and insulating materials can be wrapped for places that cannot meet the insulation requirements. Technicians can integrate, improve and cross-use the design schemes of the above-mentioned control handle 2 and guide catheter control handle 27 according to actual requirements, and these equivalent changes and modifications also fall within the scope defined by the claims of the embodiments of the present invention .
如图1所示，消融发生装置3是为消融导管1、导引导管7、控制手柄2、导引导管控制柄27上需要能量供应的部分提供相应形式的能量，例如当导引导管7需要智能材料改变形状时，消融发生装置3能够提供诱导智能材料改变形状所需要的能量。同时消融发生装置3能够接收和处理消融导管1、导引导管7、控制手柄2、导引导管控制柄27传来的信息，处理后的信息能够部分或全部显示在消融发生装置3的显示器320上，而且该处理后的信息还能够反馈调节消融发生装置3的能量输出。消融发生装置3的控制参数能够通过消融发生装置的显示器320进行触屏控制或通过参数设置按钮330进行调节；消融发生装置3应设有能量输出的接头和传感器信号输入的接头311，同时还应设有与外接电源相接的接头321，用于接收由供电电路传来的电能。对于消融导管1、控制手柄2、导引导管7和导引导管控制柄27需要能量供应而又未在控制手柄2或导引导管控制柄27上设有工作开关的设备，在消融发生装置3上优选设有工作开关。对于消融导管1或/和导引导管7需要的冷却剂、复温剂和灌注液的情况，消融发生装置3或/和导引导管7可以设有灌注器进行自动或手动向消融导管1灌注冷却剂、复温剂和灌注液，此时消融发生装置3应有相应的管路与提供冷却剂、复温剂和灌注液原料或成品的容器相通。对于导引导管7的末端开孔77连接的注液装置设置在消融发生装置3的情况，消融发生装置3应对该注液装置进行控制并设置相应的控制面板或控制按钮。消融发生装置3可以是融合上述功能于一体的整机，也可以是分别行使不同功能的分体机，例如将为射频消融电极头9供能的部分独立为一个分机，将灌注器独立为另一个分机。As shown in Figure 1, the ablation generating device 3 is to provide corresponding forms of energy for the parts on the ablation catheter 1, the guide catheter 7, the control handle 2, and the guide catheter control handle 27 that require energy supply, for example, when the guide catheter 7 requires When the smart material changes shape, the ablation generator 3 can provide the energy required to induce the smart material to change shape. At the same time, the ablation generating device 3 can receive and process the information transmitted from the ablation catheter 1, the guiding catheter 7, the control handle 2, and the guiding catheter control handle 27, and the processed information can be partially or completely displayed on the display 320 of the ablation generating device 3 In addition, the processed information can be fed back to adjust the energy output of the ablation generating device 3 . The control parameters of the ablation generating device 3 can be controlled by the touch screen through the display 320 of the ablation generating device or adjusted through the parameter setting button 330; A connector 321 connected to an external power supply is provided for receiving electric energy from the power supply circuit. For the ablation catheter 1, the control handle 2, the guide catheter 7 and the guide catheter control handle 27, which require energy supply and do not have an operating switch on the control handle 2 or the guide catheter control handle 27, the ablation generating device 3 It is preferably provided with a work switch. For the cooling agent, rewarming agent and perfusion fluid required by the ablation catheter 1 or/and the guide catheter 7, the ablation generating device 3 or/and the guide catheter 7 can be provided with a perfusion device for automatic or manual perfusion to the ablation catheter 1 Coolant, rewarming agent and perfusate. At this time, the ablation generating device 3 should have corresponding pipelines communicating with the containers for supplying coolant, rewarming agent and perfusate raw materials or finished products. For the case where the liquid injection device connected to the end opening 77 of the guide catheter 7 is set on the ablation generating device 3, the ablation generating device 3 should control the liquid injection device and provide a corresponding control panel or control button. The ablation generating device 3 can be a complete machine that integrates the above functions, or a split machine that performs different functions respectively. an extension.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210313087.9ACN102908188B (en) | 2012-08-29 | 2012-08-29 | Radio frequency ablation (RFA) catheter system for denervation of renal sympathetic nerves |
| PCT/CN2013/086076WO2014056460A1 (en) | 2012-08-29 | 2013-10-28 | Multifunctional ablation catheter system for renal sympathetic denervation |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210313087.9ACN102908188B (en) | 2012-08-29 | 2012-08-29 | Radio frequency ablation (RFA) catheter system for denervation of renal sympathetic nerves |
| Publication Number | Publication Date |
|---|---|
| CN102908188A CN102908188A (en) | 2013-02-06 |
| CN102908188Btrue CN102908188B (en) | 2015-04-08 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201210313087.9AExpired - Fee RelatedCN102908188B (en) | 2012-08-29 | 2012-08-29 | Radio frequency ablation (RFA) catheter system for denervation of renal sympathetic nerves |
| Country | Link |
|---|---|
| CN (1) | CN102908188B (en) |
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