CN103750898A - Intraluminal ablation catheter - Google Patents

Abstract

The invention provides an ablation catheter for use in human lumens. The catheter a far end, a near end, a support unit, and a slender tube body; the far end and the near end are connected through the support unit and the slender tube body. The far end is connected with an energy generator. The support unit at the far end is elastic and compressible. The support unit is single arch shaped and comprises a far end bottom, a top and a near end bottom. The support unit is provided with at least two regulation elements. The support unit is further provided with a traction wire. The catheter has the advantages of operational safety and high efficiency, and the use of the traction wire further optimizes adaptability and operability of the catheter.

Description

Translated fromChinese

一种腔内消融导管An intracavitary ablation catheter

技术领域technical field

本发明涉及医疗器械，具体涉及一种用于血管内或身体管腔内对管腔壁附近的局部组织施加能量，实现消融或神经调制的器械。The present invention relates to a medical device, in particular to a device for applying energy to local tissues near the wall of a lumen in a blood vessel or in a body lumen to realize ablation or nerve modulation.

背景技术Background technique

腔内消融导管的一种重要的应用是对肾动脉血管壁附近的局部组织施加能量。肾交感神经分布在肾动脉血管壁中，对肾动脉血管壁附近的局部组织施加能量，能有效降低肾交感神经的活性，能够使一些患者的血压降低。其典型的作用方式是经导管将调制元件输送到身体的目标管腔内，并将能量输送给管腔壁及其附近组织，从而达到目标组织的消融或其他能量调制作用。An important application of intraluminal ablation catheters is the application of energy to local tissues near the vessel wall of the renal artery. The renal sympathetic nerve is distributed in the renal artery wall, applying energy to the local tissue near the renal artery wall can effectively reduce the activity of the renal sympathetic nerve, which can lower the blood pressure of some patients. Its typical mode of action is to deliver the modulation element to the target lumen of the body through the catheter, and deliver energy to the lumen wall and nearby tissues, so as to achieve ablation of the target tissue or other energy modulation effects.

高血压是常见的慢性病，也是心脑血管病最主要的危险因素，其脑卒中、心肌梗死、心里衰竭及慢性肾病等主要并发症，不仅致残、致死率高，而且严重消耗医疗和社会资源，给家庭和国家造成沉重负担。Hypertension is a common chronic disease and the most important risk factor for cardiovascular and cerebrovascular diseases. Its major complications such as stroke, myocardial infarction, heart failure and chronic kidney disease not only cause disability and high mortality, but also seriously consume medical and social resources. , causing a heavy burden on the family and the country.

在高血压的形成机制中，肾素-血管紧张素-醛固酮系统（Renin AngiotensinAldosterone System,RAAS）是重要的血压调控系统，其通过对心脏、血管、肾脏的调节维持机体水、电解质及血压的平衡。研究证实，RAAS通过以下3个途径引起高血压：（1）RAAS激活引起钠潴留；（2）RAAS激活可以增加交感神经系统活性；（3）RAAS激活可以直接收缩血管。In the formation mechanism of hypertension, the renin-angiotensin-aldosterone system (Renin AngiotensinAldosterone System, RAAS) is an important blood pressure regulation system, which maintains the balance of water, electrolytes and blood pressure in the body through the regulation of the heart, blood vessels and kidneys . Studies have confirmed that RAAS causes hypertension through the following three pathways: (1) RAAS activation causes sodium retention; (2) RAAS activation can increase the activity of the sympathetic nervous system; (3) RAAS activation can directly constrict blood vessels.

同时，肾脏交感神经系统（Sympathetic Nervous System,SNS），特别最是分布在肾动脉壁的肾交感传出和传入神经，对于诱发和保持系统性高血压起着决定性作用。肾交感神经的过度活跃，使高血压得以维持。At the same time, the renal sympathetic nervous system (Sympathetic Nervous System, SNS), especially the renal sympathetic efferent and afferent nerves distributed in the renal artery wall, plays a decisive role in inducing and maintaining systemic hypertension. Hyperactivity of the renal sympathetic nerves maintains high blood pressure.

交感神经的过度兴奋也在一定程度上促进了RAAS的激活，提高钠的重吸收，加速心跳，及增加每搏量和外周血管的阻力，因此其还会提高患其他心血管疾病风险。据预测，高血压患者中有25%～47%同时患有胰岛素抵抗或者糖耐量减低。肾交感神经的过度活跃使得血管紧张素II分泌增加，这将导致胰岛素样生长因子-1(IGF-1)活动减少；同样地，RAAS调节增加了氧化应激(OS)也很可能致使骨骼肌的胰岛素抵抗，后者则是2型糖尿病发病的原因之一。Excessive excitation of sympathetic nerves also promotes the activation of RAAS to a certain extent, improves sodium reabsorption, accelerates heartbeat, and increases stroke volume and peripheral vascular resistance, so it also increases the risk of other cardiovascular diseases. It is predicted that 25% to 47% of hypertensive patients also suffer from insulin resistance or impaired glucose tolerance. Renal sympathetic hyperactivity leads to increased angiotensin II secretion, which leads to decreased insulin-like growth factor-1 (IGF-1) activity; similarly, RAAS regulation increases oxidative stress (OS) and is likely to lead to skeletal muscle Insulin resistance, which is one of the causes of type 2 diabetes.

国内外的实践证明，高血压是可以预防和控制的疾病，当前，高血压的主要治疗手段是通过改善生活方式及药物治疗。阻挠肾输出交感神经激化结果的药理学策略包括中枢作用抗交感神经药物、β阻滞剂、血管紧张素转换酶抑制剂、受体阻滞剂和利尿剂。然而，这些药理学策略具有明显的限制，包括有限的功效，顺应性问题，副作用等。例如，在改善生活方式的基础上，应用了足量且合理联合的3种降压药物（包括利尿剂）后，血压仍在目标水平之上，或至少需要4种药物才能使血压达标时，这一类高血压称之为难治性高血压（或顽固性高血压）。在我国，顽固性高血压患者约占高血压患者的15%～20%。因此，针对这一部分患者，在现今改善生活方式联合多种药物方案之外，探索治疗顽固性高血压的新方法，是临床迫切需要的。Practice at home and abroad has proved that hypertension is a disease that can be prevented and controlled. At present, the main treatment for hypertension is to improve lifestyle and drug treatment. Pharmacological strategies to block renal output of the effects of sympathetic stimulation include centrally acting antisympathetic drugs, beta-blockers, angiotensin-converting enzyme inhibitors, beta-blockers, and diuretics. However, these pharmacological strategies have significant limitations, including limited efficacy, compliance issues, side effects, etc. For example, on the basis of improving lifestyle, after applying a sufficient amount and a reasonable combination of 3 antihypertensive drugs (including diuretics), the blood pressure is still above the target level, or when at least 4 drugs are needed to make the blood pressure reach the target, This type of hypertension is called resistant hypertension (or resistant hypertension). In my country, patients with resistant hypertension account for about 15% to 20% of hypertensive patients. Therefore, for this part of patients, it is urgent to explore new methods for the treatment of resistant hypertension in addition to the current lifestyle improvement combined with multiple drug regimens.

经导管肾动脉交感神经消融术(RDN)，是针对肾动脉交感神经的消融策略，作为交感神经调制的方式，此方法的安全性及有效性在近年被证明，并逐渐被用于顽固性高血压患者的临床治疗。肾动脉交感神经经过消融之后，其传入及传出自主神经系统的活性降低；传出神经活性的降低诱发了肾素-醛固酮系统的活性降低、外周血管阻力的减少、钠的重吸收以及血流的增加，所有这些结果都有利于血压降低。实际上，根据Krum,H.等的临床研究团队发现，交感神经的去活性对于治疗与之相关的慢性肾脏疾病（CKD）、心脏衰竭、糖尿病及睡眠呼吸暂停等等疾病都具有临床意义。Transcatheter renal artery sympathetic nerve ablation (RDN) is an ablation strategy for renal artery sympathetic nerves. As a way of sympathetic nerve modulation, the safety and effectiveness of this method have been proven in recent years, and it is gradually being used for refractory high-risk patients. Clinical treatment of hypertensive patients. After renal artery sympathetic nerve ablation, the activity of its afferent and efferent autonomic nervous system is reduced; the reduction of efferent nerve activity induces a decrease in the activity of the renin-aldosterone system, a decrease in peripheral vascular resistance, sodium reabsorption, and blood pressure. Increased flow, all of which result in lower blood pressure. In fact, according to the clinical research team of Krum, H. et al., the deactivation of sympathetic nerves has clinical significance for the treatment of related diseases such as chronic kidney disease (CKD), heart failure, diabetes and sleep apnea.

图1显示了肾交感神经4沿着肾动脉血管壁的分布。从血管侧面看，肾交感神经4沿着血管从主动脉1经过肾动脉主干7和肾动脉分支血管70延伸到肾脏700。Figure 1 shows the distribution of renal sympathetic nerve 4 along the vessel wall of the renal artery. Viewed from the side of the blood vessel, the renal sympathetic nerve 4 extends along the blood vessel from theaorta 1 to thekidney 700 through therenal artery trunk 7 and renalartery branch vessels 70 .

现有技术中常见的一种肾神经调制的消融导管见图2。该消融导管5带有细长的管腔，其远端53具有柔性段并设置一调制单元，例如电极55，其近端51与一手柄500连接。消融导管内有导线，通过手柄500和线缆91与能量发生器9相连；同时医生可通过手柄500控制远端53的柔性段变形，来控制电极55与目标血管内壁的接触。该消融导管可经皮穿刺进入血管，在显影设备的辅助下，再经主动脉1输送至肾动脉7，通过施加热能或电能的能量作用，以调制有助于肾脏功能的神经纤维。A common ablation catheter for renal nerve modulation in the prior art is shown in FIG. 2 . Theablation catheter 5 has an elongated lumen, itsdistal end 53 has a flexible section and is provided with a modulation unit, such as anelectrode 55 , and itsproximal end 51 is connected to ahandle 500 . There are wires in the ablation catheter, which are connected to the energy generator 9 through thehandle 500 and thecable 91; at the same time, the doctor can control the deformation of the flexible section of thedistal end 53 through thehandle 500 to control the contact between theelectrode 55 and the inner wall of the target blood vessel. The ablation catheter can be punctured into blood vessels percutaneously, and then delivered to therenal artery 7 through theaorta 1 with the assistance of imaging equipment, and the nerve fibers that contribute to kidney function can be modulated by applying heat or electrical energy.

在使用时，医生先将电极55贴靠于肾动脉7靠近分支血管70分叉口的位置，进行第一点的神经调制；然后，沿远离肾脏700的方向选择新的目标位置，每一次在肾动脉的内壁上选择一个位置，医生需要将消融导管往后撤并旋转电极的角度，使目标位置在肾动脉的内壁上方向做螺旋形排布，重复操作以增加调制神经纤维的覆盖率。一般地，在单侧肾动脉需要进行4个至6个目标位置的神经调制，因此，医生需要较长的操作时间，才能完成该消融导管的多次的移动、定位及电极贴靠的操作，增加了病人的风险及痛苦。其次，在多次定位操作中，医生往往无法确定上一次或更早一次调制点的位置，很可能在同一目标位置附近做重复的神经调制，造成对血管壁的过度损伤。再次，医生通过手柄来调整远端的电极位置，完全依赖显影设备来观察电极的后撤距离及旋转角度而无法用眼睛直视，因此难以快速准确地判断相邻调制点之间的距离及角度，较难实现所预想的肾动脉内壁上的调制模式的图案花样，例如，实际的调制点可能不是螺旋形排布，而达不到预期的调制效果。When in use, the doctor first sticks theelectrode 55 to the position of therenal artery 7 close to the bifurcation of thebranch vessel 70, and performs the first neuromodulation; then, selects a new target position along the direction away from thekidney 700, each time To select a position on the inner wall of the renal artery, the doctor needs to withdraw the ablation catheter and rotate the angle of the electrode so that the target position is arranged in a spiral direction on the inner wall of the renal artery. Repeat the operation to increase the coverage of the modulated nerve fibers. Generally, neuromodulation of 4 to 6 target positions is required in the unilateral renal artery. Therefore, it takes a long time for the doctor to complete the multiple operations of moving, positioning and electrode sticking of the ablation catheter. Increased patient risk and suffering. Secondly, during multiple positioning operations, doctors are often unable to determine the position of the last or earlier modulation point, and it is likely to perform repeated nerve modulation near the same target position, causing excessive damage to the vessel wall. Thirdly, the doctor adjusts the position of the electrode at the far end through the handle, and completely relies on the developing device to observe the retreat distance and rotation angle of the electrode, and cannot look directly at it with the eyes, so it is difficult to quickly and accurately judge the distance and angle between adjacent modulation points , it is difficult to realize the expected pattern of the modulation mode on the inner wall of the renal artery, for example, the actual modulation points may not be arranged in a spiral shape, and the expected modulation effect cannot be achieved.

现有技术中的另一种用于肾动脉的消融导管如图3所示。该消融导管的远端53包括可压缩的螺旋形的支撑组件54，通过一个鞘管输送至肾动脉中的目标治疗位置后，该支撑组件从鞘管中释放后即可自动展开。该消融导管的支撑组件上具有多个电极，能同时在肾动脉内壁的多个位置进行肾神经调节。但是，由于该消融导管的支撑组件为螺旋结构，依靠其弹性而自动展开膨胀，支撑组件的膨胀压力被分散于径向周边的较大面积上，当支撑组件的刚度较小时，电极施加于血管壁的压强较小而接触效果不佳，导致其神经调制的热能利用率降低，需要更高的射频调制功率才能达到所需的调制效果。同时，更多的热量被血流带走，造成血液温度过高。反之，当支撑组件的刚度较大时，则会造成消融导管的远端较难入鞘、出鞘及在腔内输送，因此，该技术方案存在难以克服的技术矛盾。Another ablation catheter for renal arteries in the prior art is shown in FIG. 3 . Thedistal end 53 of the ablation catheter includes a compressiblehelical support assembly 54, which is delivered to the target treatment site in the renal artery through a sheath, and the support assembly can be automatically deployed after being released from the sheath. The support assembly of the ablation catheter has a plurality of electrodes, which can simultaneously regulate renal nerves at multiple positions on the inner wall of the renal artery. However, since the support assembly of the ablation catheter is a helical structure, it automatically expands and expands by virtue of its elasticity, and the expansion pressure of the support assembly is distributed over a large area in the radial direction. The pressure of the wall is small and the contact effect is not good, which leads to the reduction of the thermal energy utilization rate of its neural modulation, and requires higher radio frequency modulation power to achieve the desired modulation effect. At the same time, more heat is carried away by the blood flow, causing the blood to become overheated. On the contrary, when the rigidity of the support component is high, it will make it difficult for the distal end of the ablation catheter to be sheathed, unsheathed and transported in the cavity. Therefore, there is an insurmountable technical contradiction in this technical solution.

因此，需要对现有技术中的用于肾神经调制的消融导管进行改进。Therefore, there is a need for improvements to prior art ablation catheters for renal neuromodulation.

发明内容Contents of the invention

本发明实施例提供一种用于调制肾神经的消融导管，旨在解决现有技术中的消融导管难以实现安全高效的肾神经调制的技术问题。An embodiment of the present invention provides an ablation catheter for modulating renal nerves, aiming to solve the technical problem that the ablation catheters in the prior art are difficult to achieve safe and efficient modulation of renal nerves.

为了解决上述技术问题，本发明实施例采用以下技术方案：一种腔内消融导管，具有一个近端和一个远端，还包括连接在一起的一个细长管状的主体和一个支撑组件，所述主体通过所述近端与能量发生器连接，所述支撑组件位于所述远端，所述支撑组件具有弹性并且可被压缩，在所述支撑组件上设置至少两个调制元件，所述调制元件用于将所述能量发生器产生的能量输送到神经组织，所述支撑组件呈单拱形状，所述支撑组件具有远端底部、顶部和近端底部，所述近端底部连接所述主体；所述至少两个调制元件设置于所述的顶部，或者，在所述的顶部和所述的远端底部各设置至少一个调制元件。In order to solve the above technical problems, the embodiment of the present invention adopts the following technical solutions: an intracavitary ablation catheter has a proximal end and a distal end, and also includes an elongated tubular body and a support assembly connected together, the The main body is connected to the energy generator through the proximal end, the support assembly is located at the distal end, the support assembly is elastic and compressible, at least two modulation elements are arranged on the support assembly, and the modulation element For delivering the energy generated by the energy generator to the nerve tissue, the support assembly is in the shape of a single arch, the support assembly has a distal bottom, a top and a proximal bottom, and the proximal bottom is connected to the main body; The at least two modulation elements are arranged on the top, or at least one modulation element is respectively arranged on the top and the bottom of the distal end.

进一步的技术方案还包括，在所述支撑组件上还设置牵引丝，所述牵引丝的远端固定于所述的远端底部，所述牵引丝的近端可滑动地穿过所述的近端底部上的导向孔及所述主体的管腔而延伸到所述消融导管的近端，在所述支撑组件自动膨胀而展开时，通过操作所述牵引丝能够缩短所述远端底部与所述近端底部之间的距离以调整所述支撑组件的形状，以使每一个所述调制元件能够同时贴靠在血管内壁上。The further technical solution also includes that a pulling wire is also arranged on the support assembly, the distal end of the pulling wire is fixed on the bottom of the distal end, and the proximal end of the pulling wire slidably passes through the proximal end. The guide hole on the end bottom and the lumen of the main body extend to the proximal end of the ablation catheter. When the support assembly is automatically expanded and deployed, the pull wire can shorten the distance between the distal bottom and the ablation catheter. The distance between the bottoms of the proximal ends is adjusted to adjust the shape of the support assembly, so that each of the modulation elements can be attached to the inner wall of the blood vessel at the same time.

进一步的技术方案还包括，所述支撑组件包括连续的支撑体及包裹在所述支撑体的外面的绝缘层，所述支撑体基本为管状或者为杆状，所述支撑体具有单拱形状并使得所述支撑组件也具有相似的单拱形状，所述支撑体还包括能够分别自由弯曲的四个弯部，其中两个弯部及其之间的远端过渡段连接所述支撑体的远端底部及其顶部，另两个弯部及其之间的近端过渡段连接所述支撑体的顶部及其近端底部。A further technical solution also includes that the support assembly includes a continuous support body and an insulating layer wrapped on the outside of the support body, the support body is basically tubular or rod-shaped, the support body has a single arch shape and The support assembly also has a similar single arch shape, and the support body also includes four bends that can be bent freely respectively, wherein the two bends and the distal transition section between them connect the distal ends of the support body. The bottom of the support body and its top, and the other two bends and the proximal transition section between them connect the top of the support body and its proximal bottom.

进一步的技术方案还包括，当所述支撑体基本为管状时，所述支撑体由管材加工而成，每一个所述弯部分别具有通过除去一部分管材而形成的缺口；当所述支撑体为杆状时，每一个所述弯部的宽度和/或厚度都小于所述支撑杆的其余部分的相应尺寸。A further technical solution also includes that when the support body is substantially tubular, the support body is processed from a pipe, and each of the bends has a gap formed by removing a part of the pipe; when the support body is When rod-shaped, the width and/or thickness of each of said bent portions is smaller than the corresponding dimension of the rest of said support rod.

进一步的技术方案还包括，当所述支撑体基本为管状时，每一个所述弯部的缺口都在所述支撑体的单拱形状的内侧，或者，每一个所述弯部包含一个环或至少两个同轴串联的环并在该弯部的同一侧面留有连接部而在该弯部的相反一侧形成齿槽，分别与所述支撑体的远端底部或近端底部直接相连的两个弯部的齿槽都朝所述支撑体的单拱形状的外侧，与所述支撑体的顶部直接相连的另两个弯部的齿槽都朝所述支撑体的单拱形状的内侧。A further technical solution also includes, when the support body is substantially tubular, the notch of each of the bent parts is inside the single arch shape of the support body, or each of the bent parts comprises a ring or at least two coaxial rings connected in series, leaving a connecting portion on the same side of the bend and forming a tooth groove on the opposite side of the bend, directly connected to the bottom of the distal end or the bottom of the proximal end of the support body The alveoli of the two bends face the outer side of the single arch shape of the support body, and the alveoli of the other two bends directly connected to the top of the support body face the inner side of the single arch shape of the support body .

进一步的技术方案还包括，当所述支撑体基本为管状时，所述支撑体还包括一延伸段，所述支撑体的近端底部通过所述延伸段连接所述主体，所述延伸段为表面镂空的柔性管并与所述主体的管腔相通。A further technical solution also includes that when the support body is substantially tubular, the support body further includes an extension section, the bottom of the proximal end of the support body is connected to the main body through the extension section, and the extension section is The flexible tube is hollowed out and communicates with the lumen of the main body.

进一步的技术方案还包括，所述延伸段的表面具有交错排列的花纹缺口。A further technical solution also includes that the surface of the extension section has pattern notches arranged in a staggered manner.

进一步的技术方案还包括，当所述支撑体为杆状时，所述绝缘体为管状且包含至少两个内腔，所述支撑体位于所述绝缘体的一个内腔中。A further technical solution further includes that when the support body is rod-shaped, the insulator is tubular and includes at least two inner cavities, and the support body is located in one inner cavity of the insulator.

进一步的技术方案还包括，在所述支撑组件的远端设置一个柔性的引导段或者一个帽状的电极。A further technical solution also includes setting a flexible guide segment or a cap-shaped electrode at the distal end of the support assembly.

进一步的技术方案还包括，当所述支撑组件在自然状态时，所述支撑组件的高度在3毫米至8毫米的范围内选择，所述远端底部与近端底部之间的距离在15毫米至40毫米的范围内选择。The further technical solution also includes, when the support component is in a natural state, the height of the support component is selected within the range of 3 mm to 8 mm, and the distance between the bottom of the distal end and the bottom of the proximal end is 15 mm Choose from a range of up to 40mm.

相对于现有技术，本发明所披露的腔内消融导管的实施例取得了显著的有益效果，不仅便于通过鞘管输送到目标血管内，还能使多个电极同时密切接触血管内壁，其每一次定位可实现对多个新位点的神经组织的调制，而且定位更加安全、方便，能量传递效率更高，在保证较短的手术时间的同时还减少对病人的风险。进一步，在支撑组件的自弹性、牵引丝的控制以及鞘管的配合作用下，消融导管可在多种状态之间快速自如地切换，具有更高的安全性和可操作性。Compared with the prior art, the embodiment of the intraluminal ablation catheter disclosed in the present invention has achieved remarkable beneficial effects, not only is it convenient to transport into the target blood vessel through the sheath, but also enables multiple electrodes to closely contact the inner wall of the blood vessel at the same time, each of which One-time positioning can realize the modulation of nerve tissue at multiple new sites, and the positioning is safer and more convenient, and the energy transfer efficiency is higher, while ensuring a shorter operation time and reducing the risk to the patient. Furthermore, under the cooperation of the self-elasticity of the support component, the control of the pulling wire, and the sheath, the ablation catheter can be switched quickly and freely between various states, which has higher safety and operability.

附图说明Description of drawings

图1为肾动脉及其相关血管和器官的示意图；Figure 1 is a schematic diagram of the renal artery and its associated blood vessels and organs;

图2为现有技术中的用于调制肾动脉神经的一种消融导管的示意图；FIG. 2 is a schematic diagram of an ablation catheter for modulating renal artery nerves in the prior art;

图3为现有技术中的另一种消融导管的远端局部示意图；Fig. 3 is a partial schematic view of the distal end of another ablation catheter in the prior art;

图4为本发明的消融导管的一种实施例的示意图；Fig. 4 is a schematic diagram of an embodiment of the ablation catheter of the present invention;

图5为图4中的消融导管实施例的远端局部示意图；Fig. 5 is a partial schematic diagram of the distal end of the embodiment of the ablation catheter in Fig. 4;

图6A、图6B和图6C分别为图4中的消融导管实施例在压缩状态、自然状态和支撑状态时的远端局部示意图；Fig. 6A, Fig. 6B and Fig. 6C are partial schematic views of the distal end of the embodiment of the ablation catheter in Fig. 4 in the compressed state, the natural state and the supporting state;

图7A和图7B为是本发明的消融导管采用的一种支撑体的示意图；7A and 7B are schematic diagrams of a support used in the ablation catheter of the present invention;

图8A和图8B为本发明的消融导管的另一种实施例的远端局部示意图；8A and 8B are partial schematic diagrams of the distal end of another embodiment of the ablation catheter of the present invention;

图9A和图9B为图8A中的实施例可采用的一种支撑体的剖面示意图；9A and 9B are schematic cross-sectional views of a support that can be used in the embodiment in FIG. 8A;

图9C为图9A中的支撑体与消融导管主体连接的剖面示意图；9C is a schematic cross-sectional view of the connection between the support body and the main body of the ablation catheter in FIG. 9A;

图9D为图9A中的支撑体增加一个延伸段之后的立体图；FIG. 9D is a perspective view of the support in FIG. 9A after adding an extension;

图10A和图10B为本发明的第三种实施例采用的支撑体的结构示意图；Fig. 10A and Fig. 10B are the structural schematic diagrams of the supporting body adopted by the third embodiment of the present invention;

图11A为本发明的消融导管的第四种实施例的远端局部示意图；Fig. 11A is a partial schematic diagram of the distal end of the fourth embodiment of the ablation catheter of the present invention;

图11B为图11A所示的绝缘管的一个横截面的示意图；Fig. 11B is a schematic diagram of a cross section of the insulating tube shown in Fig. 11A;

图11C为图11A所示的帽状的电极的纵剖面示意图。FIG. 11C is a schematic longitudinal sectional view of the cap-shaped electrode shown in FIG. 11A .

具体实施方式Detailed ways

为了使本发明要解决的技术问题、技术方案及有益效果更加清楚明确，以下列举实施例结合附图，对本发明进行进一步详细说明。应当理解，以下具体实施例仅用于阐述本发明的一般原理和优选的实施方式，而不应用来限定本发明的技术方案。In order to make the technical problems, technical solutions and beneficial effects to be solved by the present invention clearer, the present invention will be further described in detail by enumerating the following embodiments in conjunction with the accompanying drawings. It should be understood that the following specific examples are only used to illustrate the general principles and preferred implementation modes of the present invention, and should not be used to limit the technical solution of the present invention.

图1显示了肾动脉的典型解剖结构。肾动脉主干7的入口处连接主动脉1，血流从主动脉1经由肾动脉7及分支血管70流向肾脏700。一般地，肾动脉主干血管的内径在3至8mm之间。本发明提供了腔内消融导管的多种实施例，消融导管的调制元件可定位于肾动脉主干7或与肾动脉主干内径相当的肾动脉分支血管70的腔内，通过肾动脉的内壁对肾神经组织进行消融。Figure 1 shows the typical anatomy of the renal artery. The entrance of the mainrenal artery 7 is connected to theaorta 1 , and blood flows from theaorta 1 to thekidney 700 via therenal artery 7 andbranch vessels 70 . Generally, the inner diameter of the main renal artery is between 3 and 8 mm. The present invention provides various embodiments of intracavitary ablation catheters. The modulating elements of the ablation catheter can be positioned in the lumen of the mainrenal artery 7 or thebranch vessel 70 of the renal artery with an inner diameter equivalent to the main renal artery, through the inner wall of the renal artery to the renal artery. Neural tissue is ablated.

实施例一Embodiment one

图4显示了本发明所揭示的腔内消融导管的第一种实施例。该消融导管具有一个细长的主体22、一个近端21和一个远端23，在远端23有一个与主体22连接的支撑组件24，该支撑组件24具有弹性，在自然状态下呈单拱形状，也就是说，该支撑组件24包括一个顶部27和分居于顶部27的两侧的两个底部26，其中，远端底部通过一弹性段与顶部27的远端连接，近端底部通过另一弹性段与顶部27的近端连接，近端底部还直接与主体22连接。支撑组件24包括一个单拱形状的支撑体（未示出），支撑组件24可以被压缩拉直而连同主体22进入鞘管中，再通过血管通路而输送到肾动脉7的内部。从鞘管中释放出来时，支撑组件24可以自动膨胀而恢复其自然的单拱形状。Fig. 4 shows the first embodiment of the intraluminal ablation catheter disclosed by the present invention. The ablation catheter has an elongatedmain body 22, aproximal end 21 and adistal end 23. At thedistal end 23, there is asupport assembly 24 connected to themain body 22. Thesupport assembly 24 is elastic and has a single arch in its natural state. Shape, that is to say, thesupport assembly 24 includes a top 27 and twobottoms 26 separated on both sides of the top 27, wherein the distal bottom is connected with the distal end of the top 27 through an elastic segment, and the proximal bottom is connected with the other end through another An elastic section is connected to the proximal end of the top 27 , and the proximal bottom is directly connected to themain body 22 . Thesupport assembly 24 includes a support body (not shown) in the shape of a single arch. Thesupport assembly 24 can be compressed and straightened to enter the sheath together with themain body 22 , and then delivered to the interior of therenal artery 7 through the vascular access. When released from the sheath, thestrut assembly 24 can self-expand to return to its natural single-arch shape.

可以在支撑组件24的顶部27和两个底部26上各设置一个调制单元，如电极25，以与目标血管的内壁接触，并向血管壁内的神经组织递送能量。应保证电极25的电路绝缘性能，最好是采用绝缘材料将电极25固定在支撑体上（未示出）。在本发明的所有实施例中，消融导管的每一个支撑组件上设置了至少两个电极，这些数量不等的电极构成一组，若无特别说明，都用电极25来统称支撑组件上的全部一组电极。A modulating unit, such as anelectrode 25, may be provided on each of the top 27 and the twobottoms 26 of thesupport assembly 24 to contact the inner wall of the target blood vessel and deliver energy to the nerve tissue within the blood vessel wall. The circuit insulation performance of theelectrode 25 should be ensured, preferably an insulating material is used to fix theelectrode 25 on a support (not shown). In all the embodiments of the present invention, at least two electrodes are provided on each support assembly of the ablation catheter, and these electrodes of varying numbers form a group. Unless otherwise specified,electrodes 25 are used to collectively refer to all electrodes on the support assembly. a set of electrodes.

该消融导管的电极25可通过主体22内部的一组导线（未示出）和手柄200外部的一组线缆91与能量发生器9建立电路连接，置于血管内的电极25可与体表电极8处于同一电路回路中，当能量发生器9发出射频能量时，电极25激发出单极（monopolar）电场。使用时，医生通过血管穿刺点建立输送路径，在消融导管的近端21操控手柄200，将支撑组件24通过输送路径推送至患者的目标血管中，进而通过手柄200操作控制构件来调整支撑组件24的形状和电极25的位置。一般来说，在消融导管进出鞘管的过程中，支撑组件24的形状就会变化，可在血管内定位支撑组件24，也可实现多个电极25同时与血管内壁的良好接触，因此，用于消融导管的常规鞘管也可有类似控制构件的作用，不难选择支撑组件24的适当参数，使消融导管的安全性和可操作性都优于现有技术。Theelectrode 25 of the ablation catheter can establish a circuit connection with the energy generator 9 through a set of wires (not shown) inside themain body 22 and a set ofcables 91 outside thehandle 200, and theelectrode 25 placed in the blood vessel can be connected to the body surface The electrodes 8 are in the same circuit loop, and when the energy generator 9 emits radio frequency energy, theelectrodes 25 excite a monopolar electric field. When in use, the doctor establishes a delivery path through the vascular puncture point, manipulates thehandle 200 at theproximal end 21 of the ablation catheter, pushes thesupport assembly 24 into the target blood vessel of the patient through the delivery path, and then operates the control member through thehandle 200 to adjust thesupport assembly 24 The shape and position of theelectrode 25. Generally speaking, when the ablation catheter enters and exits the sheath, the shape of thesupport assembly 24 will change, thesupport assembly 24 can be positioned in the blood vessel, andmultiple electrodes 25 can also be in good contact with the inner wall of the blood vessel at the same time. Therefore, using The conventional sheath used in the ablation catheter can also have the function of a similar control member, and it is not difficult to select the appropriate parameters of thesupport assembly 24, so that the safety and operability of the ablation catheter are better than the prior art.

本实施例中，作为优选的技术方案，所述的控制构件为牵引丝29，普通的鞘管只起辅助作用。该牵引丝29的远端固定于支撑组件24的远端底部，其近端穿过支撑组件24的近端底部和主体22而延伸到近端21的手柄200上。牵引丝29可以相对与支撑组件24的近端底部和主体22自由滑动，位于支撑组件24的远端底部与近端底部之间的那一段牵引丝29基本平行于顶部27。拉紧牵引丝29，可以缩小远端底部与近端底部之间的距离，增加支撑组件24的单拱形状的弯曲高度，使得电极25贴靠在目标血管内壁上，以提高能量递送效率。In this embodiment, as a preferred technical solution, the control member is a pullingwire 29, and the common sheath only plays an auxiliary role. The distal end of the pullingwire 29 is fixed to the distal bottom of thesupport assembly 24 , and its proximal end passes through the proximal bottom of thesupport assembly 24 and themain body 22 to extend to thehandle 200 of theproximal end 21 . The pullingwire 29 can slide freely relative to the proximal bottom of thesupport assembly 24 and themain body 22 , and the section of the pullingwire 29 between the distal bottom and the proximal bottom of thesupport assembly 24 is substantially parallel to the top 27 . Tightening thepull wire 29 can reduce the distance between the distal bottom and the proximal bottom, increase the bending height of the single arch shape of thesupport assembly 24, and make theelectrode 25 stick to the inner wall of the target blood vessel to improve energy delivery efficiency.

图5显示了图4中的支撑组件24的更多细节，其中的绝缘层28为剖视图，以显示出包在其内的支撑体30。支撑组件24具有轴向与径向，其轴向与主体22的轴向一致，与轴向垂直的方向为径向，绕轴向旋转的方向为周向。支撑组件24包括弹性的支撑体30及包裹在支撑体30上的绝缘层28，支撑体30具有与支撑组件24一致的单拱形状，远端底部261上有电极251，顶部27上有电极252，近端底部262上有电极253。绝缘层28可以基本为管状，保证电极251、252、253的电路绝缘性能，而每个电极都至少有一部分外表面暴露于绝缘层28之外，以与血管壁接触导通。远端底部261还可以连接一个引导段31，可通过焊接、胶粘或者过盈配合来相连，支撑组件24的远端终止于引导段31的光滑端面处，该端面可以为半球形，防止支撑组件24损伤血管内壁。牵引丝29的远端穿过绝缘层28上的切口28a固定于远端底部261；在近端底部262的附近的绝缘层28上有另一切口28b，作为引导牵引丝29滑动的导向孔，牵引丝29的近端从切口28b处穿过近端底部262，再穿过主体22的腔体而固定于手柄200，牵引丝29能够自由滑动于近端底部262和主体22所约束的轨道上。拉动牵引丝29，可以增大支撑组件24的高度，即顶部27至远端底部261与近端底部262之间连接线的垂直距离。自然状态下的支撑组件24的高度，一般会小于或等于肾动脉的内径。在一些实施例中，支撑体30和牵引丝29共同决定了支撑组件24的形状。如果无特别说明，将用底部26来统称支撑组件的远端底部261和近端底部262。FIG. 5 shows more detail of thesupport assembly 24 of FIG. 4, with the insulatinglayer 28 cut away to show thesupport body 30 encased therein. Thesupport assembly 24 has an axial direction and a radial direction, the axial direction is consistent with the axial direction of themain body 22 , the direction perpendicular to the axial direction is the radial direction, and the direction rotating around the axial direction is the circumferential direction. Thesupport assembly 24 includes anelastic support body 30 and an insulatinglayer 28 wrapped on thesupport body 30. Thesupport body 30 has a single arch shape consistent with thesupport assembly 24. There is anelectrode 251 on thebottom 261 of the distal end, and anelectrode 252 on the top 27. , there is anelectrode 253 on thebottom 262 of the proximal end. The insulatinglayer 28 can be basically tubular to ensure the circuit insulation performance of theelectrodes 251 , 252 , 253 , and at least a part of the outer surface of each electrode is exposed outside the insulatinglayer 28 to contact and conduct with the vessel wall. Thedistal bottom 261 can also be connected to aguide section 31, which can be connected by welding, gluing or interference fit. The distal end of thesupport assembly 24 terminates at the smooth end surface of theguide section 31, which can be hemispherical to prevent support.Assembly 24 damages the inner wall of the blood vessel. The distal end of the pullingwire 29 passes through theslit 28a on the insulatinglayer 28 and is fixed to thedistal bottom 261; there is anotherslit 28b on the insulatinglayer 28 near theproximal bottom 262, which serves as a guide hole for guiding the pullingwire 29 to slide, The proximal end of thetraction wire 29 passes through theproximal bottom 262 from thecutout 28b, and then passes through the cavity of themain body 22 to be fixed on thehandle 200. Thetraction wire 29 can freely slide on the track constrained by theproximal bottom 262 and themain body 22 . Pulling the pullingwire 29 can increase the height of thesupport assembly 24 , that is, the vertical distance from the top 27 to the connecting line between thedistal bottom 261 and theproximal bottom 262 . The height of thesupport assembly 24 in a natural state is generally less than or equal to the inner diameter of the renal artery. In some embodiments, thesupport body 30 and thepull wire 29 jointly determine the shape of thesupport assembly 24 . Unless otherwise specified, the bottom 26 will be used to collectively refer to thedistal bottom 261 and theproximal bottom 262 of the support assembly.

可用牵引丝29来调节支撑组件24的形状，使支撑组件24的多个电极25有效地定位于血管内壁上，消融导管的三种典型状态分别如图6A、6B、6C所示。当牵引丝29完全松弛时，支撑组件24可被压缩拉直而完全容纳于鞘管6内，再由鞘管6经主动脉1而输送到肾动脉7的入口处，图6A通过鞘管6的剖视图示意了支撑组件24的压缩状态。相对于图5中的自然状态，此时，支撑组件24的两个底部26之间的距离增大直至与支撑组件24的最大长度相当，而支撑组件24的高度变小直至顶部27与两个底部26位于同一轴线上，整个支撑组件24可以近似为直线型而基本平行于牵引丝29。当支撑组件24离开鞘管而进入血管内，就变为图6B示意的自然状态，支撑组件24自动膨胀而恢复其自然的单拱形状，此时三个电极25可以不同时接触血管的内壁，医生仍可调整支撑组件24在血管内的位置，便于电极25的重复定位。当支撑组件24不受鞘管的约束时，可拉动牵引丝29以减小两个底部26之间的距离，同时增加支撑组件24的高度直至超过其所在血管的内径，血管内的支撑组件24可变为图6C示意的支撑状态，也就是增加支撑组件24的拱形的弯度（径向尺寸）直至血管被稍微扩张，使三个电极25能够同时稳定地贴靠在血管内壁的目标位置上，从电极25到血管壁的射频能量传递效率较高而且比较稳定。Thedrag wire 29 can be used to adjust the shape of thesupport assembly 24, so thatmultiple electrodes 25 of thesupport assembly 24 can be effectively positioned on the inner wall of the blood vessel. The three typical states of the ablation catheter are shown in Figs. 6A, 6B, and 6C respectively. When the pullingwire 29 is completely relaxed, thesupport assembly 24 can be compressed and straightened to be completely accommodated in the sheath tube 6, and then the sheath tube 6 is delivered to the entrance of therenal artery 7 through theaorta 1, as shown in FIG. 6A through the sheath tube 6 The cross-sectional view of shows the compressed state of thesupport assembly 24. With respect to the natural state in Fig. 5, at this moment, the distance between the twobottoms 26 of thesupport assembly 24 increases until it is suitable with the maximum length of thesupport assembly 24, and the height of thesupport assembly 24 becomes smaller until the top 27 and the two The bottom 26 is located on the same axis, and theentire support assembly 24 can be approximately linear and substantially parallel to the pullingwire 29 . When thesupport assembly 24 leaves the sheath and enters the blood vessel, it becomes the natural state shown in FIG. 6B , and thesupport assembly 24 automatically expands to recover its natural single arch shape. At this time, the threeelectrodes 25 may not contact the inner wall of the blood vessel at the same time. The doctor can still adjust the position of thesupport assembly 24 in the blood vessel to facilitate repeated positioning of theelectrode 25 . When thesupport assembly 24 is not constrained by the sheath tube, thetraction wire 29 can be pulled to reduce the distance between the twobottoms 26, while increasing the height of thesupport assembly 24 until it exceeds the inner diameter of the blood vessel where it is located, thesupport assembly 24 in the blood vessel It can be changed to the support state shown in FIG. 6C, that is, the curvature (radial dimension) of the arch of thesupport assembly 24 is increased until the blood vessel is slightly expanded, so that the threeelectrodes 25 can be stably attached to the target position of the inner wall of the blood vessel at the same time. , the transmission efficiency of radio frequency energy from theelectrode 25 to the blood vessel wall is relatively high and relatively stable.

牵引丝29可采用外径0.08毫米至0.20毫米的镍钛丝，经过热处理使其更具柔性。还可在牵引丝29外套一根光滑微细的软导管，从而降低牵引丝29与近端底部262和主体22之间的摩擦力。还可以在手柄200上设置便于手控的致动机构，以操控牵引丝29。因此，本实施例的消融导管在血管内的单次定位操作，就能在所选区域的三个位点上完成神经消融，有利于缩短手术时间；而且，支撑组件24在自然状态与支撑状态之间的切换很便捷，使电极25在血管内的重复定位更快也更准确，拉紧牵引丝29还可以缩小支撑组件24上电极25之间的距离，能够实现更多的可定制的神经调制模式。The pullingwire 29 can be nickel-titanium wire with an outer diameter of 0.08 mm to 0.20 mm, which is more flexible after heat treatment. A smooth and fine soft catheter can also be coated on the pullingwire 29 , thereby reducing the friction between the pullingwire 29 and theproximal bottom 262 and themain body 22 . An actuating mechanism convenient for manual control can also be provided on thehandle 200 to manipulate the pullingwire 29 . Therefore, the single positioning operation of the ablation catheter in the blood vessel in this embodiment can complete the nerve ablation at three points in the selected area, which is beneficial to shorten the operation time; It is very convenient to switch betweenelectrodes 25 in blood vessels, making repeated positioning ofelectrodes 25 faster and more accurate. Tightening thepull wire 29 can also reduce the distance betweenelectrodes 25 on thesupport assembly 24, enabling more customizable nerves. modulation mode.

图7A显示了支撑体30的一种实施方式，可用弹性管材切割再定型成细长的单拱形状，其结构和工艺都比较简单。一般地，选择管材的壁厚为0.1毫米至0.3毫米，典型的取值为0.2毫米。支撑体30的远端底部301、顶部302和近端底部301的宽度可以为0.3毫米至2.0毫米，分别对应支撑组件24的远端底部261、顶部27和近端底部262。支撑体30具有单拱形状，并使得所述支撑组件24也具有相似的单拱形状。Fig. 7A shows an embodiment of thesupport body 30, which can be cut and then shaped into a slender single arch shape by elastic tubing, and its structure and process are relatively simple. Generally, the wall thickness of the selected pipe is 0.1 mm to 0.3 mm, with a typical value of 0.2 mm. The width of thedistal bottom 301 , top 302 andproximal bottom 301 of thesupport body 30 may be 0.3 mm to 2.0 mm, corresponding to thedistal bottom 261 , top 27 andproximal bottom 262 of thesupport assembly 24 . Thesupport body 30 has a single-arc shape and causes thesupport assembly 24 to also have a similar single-arc shape.

在一些实施例中，根据支撑体30轴向不同部位的刚度或装配需求，其宽度及厚度也可变化。如图7A中所示，当支撑体30弯制为单拱形状时，会形成几个弯部。具体地，弯部304与弯部305之间为远端过渡段，连接了支撑体30的近端底部301及顶部302；弯部306与弯部307之间为近端过渡段，连接了支撑体30的顶部302和远端底部303。其中每个弯部的宽度和/或厚度可以小于顶部302及底部301、303的宽度和/或厚度，也小于远端过渡段和近端过渡段的宽度和/或厚度，以利于支撑体30的预先成型。远端过渡段和近端过渡段的刚度都大于每一个弯部，以提供足够大的支撑体力。例如，弯部304的宽度比远端底部301的宽度窄，弯部304最窄的宽度与远端底部301的宽度的比值在0.3至1之间，可通过机械加工来实现，例如切割、打磨等方式。图7B为弯部304的局部俯视图，是将图7A中的局部310放大了。每个弯部的厚度也可以小于支撑体30的其余部分的厚度，每个弯部的最薄处的厚度可控制在0.05毫米至0.25毫米之间，其典型取值为0.12毫米，可采用喷砂、化学抛光等方式对管材做减薄加工。这样的弯部就比支撑体30的其余部分更柔软，有利于调整和控制支撑组件24的形状，也保证支撑组件24所需的回弹力。例如，支撑组件24更容易被压缩入鞘；用牵引丝29来调整支撑组件24的形状时，只需要弯部的变形，而底部和顶部都能够基本保持原形以支撑电极，保证布置在底部和顶部的电极稳定贴靠在血管壁上。In some embodiments, the width and thickness of the supportingbody 30 can also vary according to the rigidity or assembly requirements of different parts in the axial direction. As shown in FIG. 7A, when thesupport body 30 is bent into a single arch shape, several bends are formed. Specifically, the distal transition section between thecurved portion 304 and thecurved portion 305 connects theproximal bottom 301 and the top 302 of thesupport body 30; the proximal transition section between thecurved portion 306 and thecurved portion 307 connects the support The top 302 and thebottom 303 of the distal end of thebody 30. Wherein the width and/or thickness of each bent portion can be smaller than the width and/or thickness of the top 302 and the bottom 301,303, and also smaller than the width and/or thickness of the far-end transition section and the proximal transition section, so as to facilitate thesupport body 30 preformed. The rigidity of the distal transition section and the proximal transition section is greater than that of each bend, so as to provide sufficient supporting force. For example, the width of thecurved portion 304 is narrower than the width of thedistal bottom 301, and the ratio of the narrowest width of thecurved portion 304 to the width of thedistal bottom 301 is between 0.3 and 1, which can be achieved by machining, such as cutting and grinding and so on. FIG. 7B is a partial top view of thebent portion 304 , which enlarges thepart 310 in FIG. 7A . The thickness of each bent portion can also be smaller than the thickness of the rest of thesupport body 30, and the thickness of the thinnest part of each bent portion can be controlled between 0.05 mm and 0.25 mm, and its typical value is 0.12 mm. Sand, chemical polishing and other methods are used to thin the pipe. Such a bent portion is softer than the rest of thesupport body 30 , which is beneficial for adjusting and controlling the shape of thesupport component 24 and also ensures the required resilience of thesupport component 24 . For example, thesupport assembly 24 is more easily compressed into the sheath; when adjusting the shape of thesupport assembly 24 with thepull wire 29, only the deformation of the bend is required, and the bottom and the top can basically maintain the original shape to support the electrodes, ensuring that they are arranged at the bottom and the top. The electrodes on the top rest firmly against the vessel wall.

实施例二Embodiment two

本发明还提供腔内消融导管的另一实施例，其支撑组件24的实施方式如图8A所示。与消融导管的前述实施例有一个重要的不同之处，本实施例的支撑组件24具有管状的支撑体30，绝缘层28可以紧密地套在管状支撑体30的外表面上。The present invention also provides another embodiment of the intracavitary ablation catheter, and the embodiment of itssupport assembly 24 is shown in FIG. 8A . There is an important difference from the previous embodiments of the ablation catheter, thesupport assembly 24 of this embodiment has atubular support body 30 , and the insulatinglayer 28 can be tightly sleeved on the outer surface of thetubular support body 30 .

在一些实施方式中，绝缘层28为可热缩的套管，热缩之前的套管可以在管状的支撑体30上滑动，经过热缩后的套管直径变小，形成了缩紧在管状支撑体30外表面的绝缘层28。可热缩的套管通常是聚合物材料，例如：聚烯烃，聚四氟乙烯（PTFE），氟化乙丙稀（FEP），聚对苯二甲酸乙二酯（PET）。在其他的实施方式中，绝缘层28可以为多层的热缩套管，使支撑组件24的横截面的径向尺寸更精确地符合设计要求。In some embodiments, the insulatinglayer 28 is a heat-shrinkable sleeve. The sleeve before heat-shrinking can slide on thetubular support body 30, and the diameter of the sleeve after heat-shrinking becomes smaller, forming a shrinkage in the tubular shape. The insulatinglayer 28 on the outer surface of thesupport body 30 . Heat-shrinkable sleeves are usually polymeric materials such as: polyolefin, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyethylene terephthalate (PET). In other embodiments, the insulatinglayer 28 may be a multi-layer heat-shrinkable sleeve, so that the radial dimension of the cross-section of thesupport assembly 24 more accurately meets the design requirements.

在支撑体30上，相邻电极可以等间距地排列，例如，电极251、253可以对称地设置在电极252的两侧。在本实施例中，每个电极可以是具有一定长度的金属环，在管状的支撑体30及绝缘层28上的固定效果更佳。例如，电极采用纯度为99.95%的黄金，其长度在0.5毫米至3毫米之间选择。在类似的实施方式中，可有不同的电极数量和布置方式，每个电极的长度也可以不相等。图8B为支撑组件24的远端局部B的放大剖视图，显示了支撑组件24远端的电极251的设置方式。可采用机械磨压方式，将电极251嵌入绝缘层28的外壁，电极251的外表面与绝缘层28的外表面平齐。On thesupport body 30 , adjacent electrodes may be arranged at equal intervals, for example, theelectrodes 251 and 253 may be symmetrically arranged on both sides of theelectrode 252 . In this embodiment, each electrode can be a metal ring with a certain length, and the fixing effect on thetubular support body 30 and the insulatinglayer 28 is better. For example, the electrodes are made of gold with a purity of 99.95%, and their length can be selected between 0.5 mm and 3 mm. In similar embodiments, there may be different numbers and arrangements of electrodes, and the lengths of each electrode may also be unequal. FIG. 8B is an enlarged cross-sectional view of a portion B of the distal end of thesupport assembly 24 , showing the arrangement of theelectrodes 251 at the distal end of thesupport assembly 24 . Theelectrode 251 can be embedded into the outer wall of the insulatinglayer 28 by mechanical grinding and pressing, and the outer surface of theelectrode 251 is flush with the outer surface of the insulatinglayer 28 .

本实施例中，引导段31包括一段弹簧管312，可用金属细丝绕制，其最远端可加工成一个半球形的端头311，一根弹性丝313设置于弹簧管312的内腔并有一端固定在端头311上，弹簧管312的近端及弹性丝312的近端都沿着远端底部261的轴向并固定在远端底部261的管腔内，可通过锡焊、过盈配合、粘胶等类似方式固定。引导段31的远端可为弧形，以适应不同的血管解剖结构。为了保证引导段31的柔性，减少对血管的摩擦损伤，同时为消融导管提供更好的导向作用，优选地，弹簧管312和弹性丝313都可采用镍钛合金，长度可设置为5毫米至20毫米。In this embodiment, theguide section 31 includes a section ofspring tube 312, which can be wound with a metal filament, and its farthest end can be processed into ahemispherical end 311. Anelastic wire 313 is arranged in the inner cavity of thespring tube 312 and One end is fixed on theend head 311, the proximal end of thespring tube 312 and the proximal end of theelastic wire 312 are fixed in the lumen of thedistal bottom 261 along the axial direction of thedistal bottom 261, and can be soldered, passed Fit, glue, etc. to fix. The distal end of theguide segment 31 can be arc-shaped to adapt to different anatomical structures of blood vessels. In order to ensure the flexibility of theguide section 31, reduce the frictional damage to blood vessels, and provide better guidance for the ablation catheter, preferably, both thespring tube 312 and theelastic wire 313 can be made of nickel-titanium alloy, and the length can be set from 5 mm to 20 mm.

图8B还显示，导线32从支撑体30的管腔内连接到远端电极251上。图9A进一步示意了支撑体30的剖面图，导线一般从管腔300的内部通过，在支撑体30的远端底部301、顶部302和近端底部303分别设置了允许每个电极或传感器的导线（未示出）通过的细孔321、322、323，两个弯部304、305连接了近端底部301和顶部302，另两个弯部306、307连接了顶部302和远端底部303。管状的支撑体30上还可容纳传感器，如温度传感器。支撑体30可以采用具有超弹性的管材，如外径为1.0毫米至3.0毫米的镍钛管，典型外径为1.4毫米。通过机械加工，例如激光切割，去除支撑体30的每个弯部的内侧的多余材料，仅在底部301、303和顶部302附近保留完整的局部管体。然后，将支撑体30弯制为单拱形状，再做热处理定型。FIG. 8B also shows that thewire 32 is connected to thedistal electrode 251 from the lumen of thesupport body 30 . Fig. 9A further illustrates the cross-sectional view of thesupport body 30. The wires generally pass through the inside of thelumen 300, and thedistal bottom 301, top 302, andproximal bottom 303 of thesupport body 30 are respectively provided with wires that allow each electrode or sensor (not shown) through thethin holes 321 , 322 , 323 , twobends 304 , 305 connect theproximal bottom 301 and top 302 , and the other twobends 306 , 307 connect the top 302 anddistal bottom 303 . Sensors, such as temperature sensors, can also be accommodated on thetubular support body 30 . Thesupport body 30 can be made of a tube with superelasticity, such as a nickel-titanium tube with an outer diameter of 1.0 mm to 3.0 mm, and a typical outer diameter is 1.4 mm. By mechanical processing, such as laser cutting, excess material is removed from the inside of each bend of thesupport body 30 , leaving complete partial pipe bodies only near the bottom 301 , 303 and top 302 . Then, thesupport body 30 is bent into a single arch shape, and then heat-treated to shape it.

调整支撑体30的单拱形状，可使支撑体30从图9A所示的自然状态变为图9B所示的支撑状态，则顶部302至远端底部301与近端底部303之间连线的垂直距离（即支撑体30的高度）增加，弯部304与弯部307间的距离（即支撑体30的可调节长度）减小。例如，对于自然状态的支撑体30，其高度可设置为4毫米，可调节长度可设置为16.8毫米；在牵引丝29的作用下，支撑体30可变为支撑状态，单拱形状的弯度达到极限时，支撑体30的高度可增至7.4毫米，可调节长度可减至6毫米。实际上，在牵引丝29的控制下，处于支撑状态的支撑体30的高度可在4毫米至7.4毫米之间变化，可调节长度可在16.8毫米至6毫米之间变化，以适应不同内径的肾动脉。医生可借助显影设备，及能量发生器面板上的阻抗显示，来判定支撑组件24上的电极与肾动脉内壁之间的接触状况，进而控制牵引丝29的拉力，以使电极在肾动脉内壁上重复定位并使电极贴靠在肾动脉内壁上的效果更好。支撑体30选择的上述尺寸，可适应内径为4.5毫米至7毫米的肾动脉。在其他实施例中，支撑体30在自然状态的可调节长度可设置在6毫米至35毫米之间，在支撑状态时的可调节长度处于4毫米至20毫米之间。这样的消融导管可适应内径为3毫米至9毫米的肾动脉，在长度为10毫米至50毫米的肾动脉区域内重复定位和调制肾神经。Adjusting the single arch shape of thesupport body 30 can make thesupport body 30 change from the natural state shown in FIG. 9A to the support state shown in FIG. As the vertical distance (ie, the height of the support body 30 ) increases, the distance between thebent portion 304 and the bent portion 307 (ie, the adjustable length of the support body 30 ) decreases. For example, for thesupport body 30 in the natural state, its height can be set to 4 millimeters, and the adjustable length can be set to 16.8 millimeters; At the limit, the height of thesupport body 30 can be increased to 7.4 mm, and the adjustable length can be reduced to 6 mm. In fact, under the control of the pullingwire 29, the height of the supportingbody 30 in the supporting state can be changed between 4mm and 7.4mm, and the adjustable length can be changed between 16.8mm and 6mm, so as to adapt to different inner diameters. renal artery. The doctor can judge the contact condition between the electrode on thesupport assembly 24 and the inner wall of the renal artery by means of the imaging device and the impedance display on the panel of the energy generator, and then control the pulling force of the pullingwire 29 so that the electrode is on the inner wall of the renal artery. Repeated positioning and placement of the electrode against the inner wall of the renal artery is more effective. The above-mentioned size selected for thesupport body 30 can be adapted to a renal artery with an inner diameter of 4.5 mm to 7 mm. In other embodiments, the adjustable length of thesupport body 30 in the natural state can be set between 6 mm and 35 mm, and the adjustable length in the supporting state is between 4 mm and 20 mm. Such ablation catheters can accommodate renal arteries with internal diameters ranging from 3 mm to 9 mm, repeatedly positioning and modulating renal nerves in the region of renal arteries with lengths ranging from 10 mm to 50 mm.

如图9C所示，在近端底部303附近保留了一段基本完整的管材，此段管材从近端底部303的边缘310向远端方向延伸的长度可设置为0.5毫米至2.5毫米，用于连接近端底部303与消融导管的主体22，可以直接套在主体22远端的柔性段220上。牵引丝29的近端刚好可以穿过近端底部303和柔性段220的内腔而连接到手柄200上，这种结构非常有利于牵引丝29的调控和自由滑动。若采用金属材料制作柔性段220，可用激光点焊来固定连接近端底部303与柔性段220，焊点308与近端底部303的边缘310的距离可为0.5毫米至1.5毫米。As shown in FIG. 9C , a substantially complete section of tubing remains near theproximal bottom 303 , and the length of this section of tubing extending from theedge 310 of theproximal bottom 303 to the distal direction can be set to 0.5 mm to 2.5 mm for connection. Theproximal bottom 303 and themain body 22 of the ablation catheter can be directly sleeved on theflexible section 220 at the distal end of themain body 22 . The proximal end of the pullingwire 29 can just pass through thebottom 303 of the proximal end and the lumen of theflexible section 220 to be connected to thehandle 200 . This structure is very conducive to the regulation and free sliding of the pullingwire 29 . If metal material is used to make theflexible section 220, theproximal bottom 303 and theflexible section 220 can be fixedly connected by laser spot welding, and the distance between the welding spot 308 and theedge 310 of theproximal bottom 303 can be 0.5 mm to 1.5 mm.

在支撑体30的另一实施例中，可在近端底部303上直接增加一定长度的延伸段309，如图9D所示。例如，用激光切割管材制作支撑体30时，在近端底部303附近预留长度为50毫米至120毫米的一段管材，并利用激光切割镂空该段管材，形成柔性的延伸段309，其表面的交错排列的花纹缺口允许延伸段309朝各方向自由弯折。支撑体30在焊点308附近的部分具有较大的刚度，若消融导管的主体22的远端被固定连接到延伸段309上，焊点308与支撑体30的单拱形状的距离适当增大，使得支撑体30更容易弯折而顺利通过肾动脉7与主动脉1之间的直角分叉口，减小对血管的损伤。支撑体30的延伸段309带有交错的镂空花纹，还使消融导管的远端兼具柔顺性和扭控性，也便于容纳牵引丝29并有利于调控和自由滑动牵引丝29，因此，更加有利于支撑组件24在血管内的重复定位。In another embodiment of thesupport body 30 , an extension section 309 of a certain length can be directly added to theproximal bottom 303 , as shown in FIG. 9D . For example, when using a laser-cut tube to make thesupport body 30, a section of tube with a length of 50 mm to 120 mm is reserved near theproximal bottom 303, and the tube is hollowed out by laser cutting to form a flexible extension 309. The staggered notches allow the extension section 309 to bend freely in all directions. The part of thesupport body 30 near the welding point 308 has relatively high rigidity. If the distal end of themain body 22 of the ablation catheter is fixedly connected to the extension section 309, the distance between the welding point 308 and the single arch shape of thesupport body 30 is appropriately increased. , so that thesupport body 30 is easier to bend and smoothly pass through the right-angle bifurcation between therenal artery 7 and theaorta 1 , reducing damage to blood vessels. The extension section 309 of thesupport body 30 has a staggered hollow pattern, which also makes the distal end of the ablation catheter both flexible and twist-controllable, and is also convenient for accommodating the pullingwire 29 and facilitating the adjustment and free sliding of the pullingwire 29. Therefore, it is more This facilitates repeated positioning of thesupport assembly 24 within the blood vessel.

实施例三Embodiment Three

本发明还提供消融导管的另一个实施例，其具有如图10A所示的支撑体30。与前述实施例的主要区别之一在于，管状的支撑体30的每一个弯部包含一个环或者至少两个沿轴向串联的环，每一个环都通过连接部与支撑体30相连，所述的连接部在相应弯部的同一侧，在每个环的轴向两端都有同向的缺口，所述缺口都在相应弯部的另一侧，也就是与连接部相对的那一侧。当绝缘层28套在支撑体30外表面上时，覆盖在弯部附近的绝缘层28在受到所述环的支撑和保护，基本不会在镂空的缺口处形成褶皱或者塌陷，绝缘层28外表面保持圆滑，避免对血管内壁造成损伤。并且，支撑体30在每个弯部附近基本保留了较为完整的内腔和光滑内壁，更易于在支撑体30的内腔中设置电极导线（未示出）及传感器导线（未示出）。The present invention also provides another embodiment of the ablation catheter, which has asupport body 30 as shown in FIG. 10A . One of the main differences from the previous embodiments is that each bend of thetubular support body 30 includes a ring or at least two rings connected in series in the axial direction, and each ring is connected to thesupport body 30 through a connecting portion. The connecting part of the ring is on the same side of the corresponding bending part, and there are notches in the same direction at both axial ends of each ring, and the notches are all on the other side of the corresponding bending part, that is, the side opposite to the connecting part . When the insulatinglayer 28 is sleeved on the outer surface of thesupport body 30, the insulatinglayer 28 covering the vicinity of the bend is supported and protected by the ring, and basically no wrinkles or collapse will be formed at the hollowed-out gap. The surface is kept smooth to avoid damage to the inner wall of the blood vessel. Moreover, thesupport body 30 basically retains a relatively complete inner cavity and a smooth inner wall near each bend, making it easier to arrange electrode wires (not shown) and sensor wires (not shown) in the inner cavity of thesupport body 30 .

图10B示意了镂空后的管材的大致结构，这是在管材弯折定形之前的侧视图。以弯部304为例，同轴地串联了三个环304a、304b、304c，相邻环之间的连接部在同一侧，相邻环之间的缺口共同朝向另一侧，共同构成齿槽。当支撑体30弯折定形后，远端底部301附近的弯部304的齿槽朝单拱形状的外侧，近端底部303附近的弯部307的齿槽也朝单拱形状的外侧，而靠近顶部302的两个弯部305、306的齿槽都朝单拱形状的内侧，任一齿槽都不会阻碍支撑体30的变形。也就是说，齿槽都背离支撑组件24与血管内壁接触的部分，每个弯部可能与血管内壁接触的部分都有完整光滑的管壁，因此，带有齿槽的弯部不会损伤血管壁。环间距可以相等或不等，可设置为0.2毫米至1.5毫米。环的长度可以相等或不等，可设置为0.1毫米至1毫米。在本实施例中，其中两个弯部304、307各包括三个环，另两个弯部305、306各包括两个环。应当理解，每个弯部可有其它数量的环，这些环也可呈楔形突出而形成锯齿槽，每个弯部的环和齿槽还可有其它的形状、尺寸和布置。Fig. 10B shows the general structure of the hollowed-out pipe, which is a side view before the pipe is bent and shaped. Taking thebent part 304 as an example, threerings 304a, 304b, 304c are coaxially connected in series, the connecting parts between adjacent rings are on the same side, and the gaps between adjacent rings face the other side together to form the cog . When thesupport body 30 is bent and shaped, the alveolar of thebent portion 304 near thebottom 301 of the distal end is toward the outside of the single-arch shape, and the alveolar of thebent portion 307 near thebottom 303 of the proximal end is also toward the outer side of the single-arch shape, and close to the single-arch shape. The tooth grooves of the twocurved parts 305 , 306 of the top 302 are all facing the inner side of the single arch shape, and any tooth groove will not hinder the deformation of thesupport body 30 . That is to say, the alveoli are away from the part of thesupport assembly 24 in contact with the inner wall of the blood vessel, and the part where each bend may contact the inner wall of the blood vessel has a complete and smooth wall, so the bend with the alveolar will not damage the blood vessel wall. The ring spacing can be equal or different, and can be set from 0.2 mm to 1.5 mm. The length of the rings can be equal or different, and can be set from 0.1 mm to 1 mm. In this embodiment, each of the twobent portions 304, 307 includes three rings, and each of the other twobent portions 305, 306 includes two rings. It should be understood that there may be other numbers of rings per bend, that the rings may project wedge-shaped to form serrations, and that the rings and grooves of each bend may have other shapes, sizes and arrangements.

由于支撑体30具有比较完整的内腔空间和比较光滑的内壁，牵引丝29的近端也可以从远端底部301穿过整个支撑体30的内腔直至离开近端底部303的管口，再进入主体22的内腔。Since thesupport body 30 has a relatively complete inner lumen space and a relatively smooth inner wall, the proximal end of the pullingwire 29 can also pass through the inner cavity of theentire support body 30 from thedistal bottom 301 until it leaves the nozzle of theproximal bottom 303, and then into the lumen of thebody 22.

本实施例可以只采用两个电极，分别设置在远端底部301和顶部302，而支撑体30的近端底部303不需要承载电极而可以尽量缩短，并且近端底部303不需要完全进入肾动脉7，因此，这样的消融导管更容易通过弯曲角度较大的血管，也更适合肾动脉7较短的情况。In this embodiment, only two electrodes can be used, which are arranged on thedistal bottom 301 and the top 302 respectively, while theproximal bottom 303 of thesupport body 30 does not need to carry electrodes and can be shortened as much as possible, and theproximal bottom 303 does not need to completely enter therenal artery 7. Therefore, such an ablation catheter is easier to pass through blood vessels with larger bending angles, and is also more suitable for the condition that therenal artery 7 is shorter.

顶部302可比底部301、303更长，也能够比底部301、303更稳定地贴靠血管壁，从而使得布置于支撑体顶部302的电极的消融效果更有保障，因此，顶部302可装载较长的电极252，或者装载多个分离的电极252。The top 302 can be longer than the bottom 301, 303, and can also be more stable against the blood vessel wall than the bottom 301, 303, so that the ablation effect of the electrode arranged on the top 302 of the support is more guaranteed. Therefore, the top 302 can be loaded with a longer Theelectrode 252, or load a plurality ofseparate electrodes 252.

实施例四Embodiment four

本发明还提供了消融导管的另一种实施例，其支撑组件24如图11A和图11B所示，包含一个支撑体30、电极251、电极252及绝缘管280。与前述实施方式的一个主要不同之处在于，绝缘管280内设置了平行于其轴线的支撑体腔281和导线腔282，支撑体30套在支撑体腔281的内部，导线腔282用于容纳电极导线32及传感器导线34，这样有利于设置和保护各种导线。图11B为图11A中的绝缘管280的C-C截面的剖视图。The present invention also provides another embodiment of the ablation catheter. As shown in FIG. 11A and FIG. 11B , thesupport assembly 24 includes asupport body 30 ,electrodes 251 ,electrodes 252 and insulatingtubes 280 . One main difference from the previous embodiments is that asupport body cavity 281 and aguide wire cavity 282 parallel to its axis are provided in the insulatingtube 280, thesupport body 30 is sleeved inside thesupport body cavity 281, and theguide wire cavity 282 is used to accommodate electrode leads 32 andsensor wire 34, which is conducive to setting and protecting various wires. FIG. 11B is a sectional view of the C-C section of the insulatingtube 280 in FIG. 11A .

固定于绝缘管280的最远端的电极251为帽状，图11C为电极251的内部结构的剖视图。电极251具有半球形空腔，其端部圆滑并与绝缘管280表面有光滑的过渡，可在电极251的腔内设置一个温度传感器33，利用热传导树脂固定，使得电极251与肾动脉7之间的接触点71有更好的效果，也利于精确监控血管壁的局部温度变化，防止局部血管过热。Theelectrode 251 fixed at the farthest end of the insulatingtube 280 is in the shape of a cap, and FIG. 11C is a cross-sectional view of the internal structure of theelectrode 251 . Theelectrode 251 has a hemispherical cavity, and its end is smooth and has a smooth transition with the surface of the insulatingtube 280. A temperature sensor 33 can be arranged in the cavity of theelectrode 251, and it can be fixed with a heat-conducting resin so that there is a gap between theelectrode 251 and therenal artery 7. The contact point 71 has a better effect, and is also conducive to accurately monitoring the local temperature change of the blood vessel wall to prevent local blood vessel overheating.

可在距电极251约0.5毫米至1毫米的管腔281外表面处开一细孔281a，见图11C，牵引丝29的远端穿过细孔281a而固定在支撑体30的远端，牵引丝29的近端穿过绝缘管280的近端外壁上的导向孔（未示出）回到支撑体腔281的内部，再延伸至主体22的近端。A thin hole 281a can be opened on the outer surface of thelumen 281 about 0.5 mm to 1 mm away from theelectrode 251, as shown in FIG. The proximal end of thebody 29 passes through a guide hole (not shown) on the proximal outer wall of the insulatingtube 280 to return to the interior of the supportingbody cavity 281 , and then extends to the proximal end of themain body 22 .

在本实施例中，可采用如图7A所示的切割管材形成的支撑体30，也可以用直径为0.1毫米至0.5毫米的镍钛丝制作支撑体30。In this embodiment, thesupport body 30 formed by cutting a pipe as shown in FIG. 7A can be used, and thesupport body 30 can also be made of nickel-titanium wire with a diameter of 0.1 mm to 0.5 mm.

还可直接在绝缘管280的外表面设置亲水涂层，以减少绝缘管280表面与鞘管或血管之间的摩擦力。A hydrophilic coating can also be directly provided on the outer surface of the insulatingtube 280 to reduce friction between the surface of the insulatingtube 280 and the sheath or blood vessel.

应当理解，上述仅为本发明的腔内消融导管的若干优选实施例。对于本领域的一般技术人员，可根据上述特定实施例进行选择组合，结合所述多种功能优点，以直接达成本发明技术方案的其它实施方式。凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，基于本发明的目的、实质和启示，均应包含在本发明所主张的保护范围之内。It should be understood that the above are only some preferred embodiments of the intraluminal ablation catheter of the present invention. Those skilled in the art can select and combine according to the above-mentioned specific embodiments, and combine the various functional advantages described above, so as to directly achieve other implementation modes of the technical solution of the present invention. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present invention, based on the purpose, essence and revelation of the present invention, shall be included within the scope of protection claimed by the present invention.

Claims (10)

Translated fromChinese

1.一种腔内消融导管，具有一个近端和一个远端，还包括连接在一起的一个细长管状的主体和一个支撑组件，所述主体通过所述近端与能量发生器连接，所述支撑组件位于所述远端，所述支撑组件具有弹性并且可被压缩，在所述支撑组件上设置至少两个调制元件，所述调制元件用于将所述能量发生器产生的能量输送到神经组织，其特征在于：所述支撑组件呈单拱形状，所述支撑组件具有远端底部、顶部和近端底部，所述近端底部连接所述主体；所述至少两个调制元件设置于所述的顶部，或者，在所述的顶部和所述的远端底部各设置至少一个调制元件。1. An intracavitary ablation catheter has a proximal end and a distal end, and also includes an elongated tubular main body and a support assembly connected together, the main body is connected with the energy generator through the proximal end, the The support assembly is located at the distal end, the support assembly is elastic and compressible, and at least two modulation elements are arranged on the support assembly, and the modulation elements are used to transmit the energy generated by the energy generator to Nerve tissue, characterized in that: the support assembly is in the shape of a single arch, the support assembly has a distal bottom, a top and a proximal bottom, and the proximal bottom is connected to the main body; the at least two modulation elements are arranged on The top, or at least one modulating element is respectively arranged on the top and the bottom of the distal end.2.一种如权利要求1所述的腔内消融导管，其特征在于：在所述支撑组件上还设置牵引丝，所述牵引丝的远端固定于所述的远端底部，所述牵引丝的近端可滑动地穿过所述的近端底部上的导向孔及所述主体的管腔而延伸到所述消融导管的近端，在所述支撑组件自动膨胀而展开时，通过操作所述牵引丝能够缩短所述远端底部与所述近端底部之间的距离以调整所述支撑组件的形状，以使每一个所述调制元件能够同时贴靠在血管内壁上。2. An intracavity ablation catheter according to claim 1, characterized in that: a pulling wire is also arranged on the support assembly, the distal end of the pulling wire is fixed on the bottom of the distal end, and the pulling wire The proximal end of the wire is slidably passed through the guide hole on the bottom of the proximal end and the lumen of the main body to extend to the proximal end of the ablation catheter. The pulling wire can shorten the distance between the distal bottom and the proximal bottom to adjust the shape of the support assembly, so that each of the modulation elements can be attached to the inner wall of the blood vessel at the same time.3.一种如权利要求1或2所述的腔内消融导管，其特征在于：所述支撑组件包括连续的支撑体及包裹在所述支撑体的外面的绝缘层，所述支撑体基本为管状或者为杆状，所述支撑体具有单拱形状并使得所述支撑组件也具有相似的单拱形状，所述支撑体还包括能够分别自由弯曲的四个弯部，其中两个弯部及其之间的远端过渡段连接所述支撑体的远端底部及其顶部，另两个弯部及其之间的近端过渡段连接所述支撑体的顶部及其近端底部。3. An intracavity ablation catheter according to claim 1 or 2, characterized in that: the support assembly includes a continuous support body and an insulating layer wrapped around the support body, and the support body is basically Tubular or rod-shaped, the support body has a single arch shape and makes the support assembly also have a similar single arch shape, and the support body also includes four bends that can be bent freely respectively, of which two bends and The distal transition section between them connects the distal bottom of the support body and its top, and the other two bends and the proximal transition section therebetween connect the top of the support body and its proximal bottom.4.一种如权利要求3所述的腔内消融导管，其特征在于：当所述支撑体基本为管状时，所述支撑体由管材加工而成，每一个所述弯部分别具有通过除去一部分管材而形成的缺口；当所述支撑体为杆状时，每一个所述弯部的宽度和/或厚度都小于所述支撑杆的其余部分的相应尺寸。4. An intracavity ablation catheter as claimed in claim 3, characterized in that: when the support body is substantially tubular, the support body is processed from a pipe material, and each of the curved parts has a A notch formed by a part of the pipe; when the support body is rod-shaped, the width and/or thickness of each of the bent parts is smaller than the corresponding size of the rest of the support rod.5.一种如权利要求4所述的腔内消融导管，其特征在于：当所述支撑体基本为管状时，每一个所述弯部的缺口都在所述支撑体的单拱形状的内侧，或者，每一个所述弯部包含一个环或至少两个同轴串联的环并在该弯部的同一侧面留有连接部而在该弯部的相反一侧形成齿槽，分别与所述支撑体的远端底部或近端底部直接相连的两个弯部的齿槽都朝所述支撑体的单拱形状的外侧，与所述支撑体的顶部直接相连的另两个弯部的齿槽都朝所述支撑体的单拱形状的内侧。5. An intracavitary ablation catheter according to claim 4, wherein when the support body is substantially tubular, the notches of each of the curved portions are inside the single arch shape of the support body , or, each of the bends comprises a ring or at least two rings coaxially connected in series and leaves a connecting portion on the same side of the bend and forms a tooth groove on the opposite side of the bend, which are respectively connected to the The alveoli of the two curved parts directly connected to the bottom of the distal end or the bottom of the proximal end of the support body are all facing the outside of the single arch shape of the support body, and the teeth of the other two curved parts directly connected to the top of the support body The grooves are all towards the inside of the single arch shape of the support.6.一种如权利要求3所述的腔内消融导管，其特征在于：当所述支撑体基本为管状时，所述支撑体还包括一延伸段，所述支撑体的近端底部通过所述延伸段连接所述主体，所述延伸段为表面镂空的柔性管并与所述主体的管腔相通。6. An intracavity ablation catheter according to claim 3, wherein when the support body is substantially tubular, the support body further comprises an extension section, and the bottom of the proximal end of the support body passes through the The extension section is connected to the main body, and the extension section is a flexible tube hollowed out on the surface and communicates with the lumen of the main body.7.一种如权利要求6所述的腔内消融导管，其特征在于：所述延伸段的表面具有交错排列的花纹缺口。7. An intracavity ablation catheter according to claim 6, characterized in that: the surface of the extension section has pattern notches arranged in a staggered manner.8.一种如权利要求3所述的腔内消融导管，其特征在于：当所述支撑体为杆状时，所述绝缘体为管状且包含至少两个内腔，所述支撑体位于所述绝缘体的一个内腔中。8. An intraluminal ablation catheter according to claim 3, wherein when the support body is rod-shaped, the insulator is tubular and contains at least two lumens, and the support body is located in the In a cavity of the insulator.9.一种如权利要求1或2所述的腔内消融导管，其特征在于：在所述支撑组件的远端设置一个柔性的引导段或者一个帽状的电极。9. An intracavity ablation catheter according to claim 1 or 2, characterized in that: a flexible guide segment or a cap-shaped electrode is arranged at the distal end of the support assembly.10.一种如权利要求1或2所述的腔内消融导管，其特征在于：当所述支撑组件在自然状态时，所述支撑组件的高度在3毫米至8毫米的范围内选择，所述远端底部与近端底部之间的距离在15毫米至40毫米的范围内选择。10. An intracavity ablation catheter according to claim 1 or 2, characterized in that: when the support component is in a natural state, the height of the support component is selected within the range of 3 mm to 8 mm, the The distance between the distal bottom and the proximal bottom is selected in the range of 15 mm to 40 mm.

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