CN110507406A - Cryoablation catheter and application thereof - Google Patents
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Abstract
本发明涉及一种冷冻消融导管及其应用,该冷冻消融导管包括设置隔热区域和消融区域的可扩张构件和管路,管路包括分别与可扩张构件的内腔室连通的进气管路和回气管路;可扩张构件设置有扩张态和收缩态,冷冻介质由进气管路进入可扩张构件内使其成扩张态,隔热区域隔离冷冻介质的冷量传递,消融区域实现冷量传递进行冷冻消融,冷冻介质通过回气管路回流。上述处于扩张状态时的冷冻消融导管具有较大的囊体以用于充分冷量热交换,从而使冷冻损伤穿透整个气道壁,且其设置消融和隔热区域以尽量减少非必要组织的损伤,该冷冻消融导管尤其适用于肺迷走神经损伤,其使用内窥镜配合冷冻消融方法,在达到损伤神经的同时,可有效控制该消融方法的并发症。
The present invention relates to a cryoablation catheter and its application. The cryoablation catheter includes an expandable member and a pipeline provided with a thermal insulation area and an ablation area, and the pipeline includes an air inlet pipeline and an Return air pipeline; the expandable member is provided with an expanded state and a contracted state, the freezing medium enters the expandable member from the intake pipe to make it into an expanded state, the heat insulation area isolates the cold transfer of the freezing medium, and the ablation area realizes the cold transfer. In cryoablation, the cryogenic medium is returned through the return gas line. The above-mentioned cryoablation catheter in the expanded state has a larger balloon for sufficient cold and heat exchange, so that the cryo-injury can penetrate the entire airway wall, and it provides an ablation and thermal insulation zone to minimize unnecessary tissue damage. Injury, the cryoablation catheter is especially suitable for pulmonary vagus nerve injury. It uses an endoscope combined with cryoablation method to effectively control the complications of the ablation method while achieving nerve injury.
Description
技术领域technical field
本发明涉及冷冻消融技术领域,尤其涉及一种冷冻消融导管及其应用。The invention relates to the technical field of cryoablation, in particular to a cryoablation catheter and its application.
背景技术Background technique
冷冻消融,是利用对局部组织的冷冻,可控地破坏组织的治疗方法。冷冻消融在气道使用时,与热消融相比,冷冻不易导致软骨的损伤,很少发生气道软化、塌陷,防止继发动力性狭窄;冷冻治疗较少引起冰冻部位与周围组织的黏连;可控深度的冷冻治疗对邻近的大血管和气管不易造成严重伤害,不易造成穿孔出血,且利于组织修复;冷冻消融不促进肉芽组织增生,不容易产生瘢痕组织。Cryoablation is a treatment that destroys tissue in a controlled manner by freezing local tissue. When cryoablation is used in the airway, compared with thermal ablation, freezing is not easy to cause cartilage damage, and airway softening and collapse rarely occur, preventing secondary dynamic stenosis; cryotherapy is less likely to cause adhesion between the frozen part and surrounding tissues ; The cryotherapy with controllable depth is not easy to cause serious damage to the adjacent large blood vessels and trachea, it is not easy to cause perforation and bleeding, and it is conducive to tissue repair; cryoablation does not promote the proliferation of granulation tissue, and is not easy to produce scar tissue.
阻塞性肺病,包括哮喘,肺气肿或慢性支气管炎等,在美国发病人数超过2500万人,目前对这些疾病总费用的估计超过200亿美元。由于空气污染、吸烟等因素,发病率正在增加。Obstructive pulmonary disease, including asthma, emphysema, or chronic bronchitis, affects more than 25 million people in the United States, and the total cost of these diseases is currently estimated at more than $20 billion. The incidence is increasing due to factors such as air pollution and smoking.
慢性阻塞性肺疾病(chronic obstructive pulmonary disease,COPD)是一种常见的以持续气流受限为特征的可以预防和治疗的疾病,气流受限进行性发展,与气道和肺脏对有毒颗粒或气体的慢性炎性反应增强有关。哮喘的标志是由支气管内衬平滑肌的急性收缩(肺部空气通道)引起的呼吸困难的急性发作,减少气道直径并增加气流阻力。哮喘中的支气管收缩是“可逆的”,因为急性收缩可以通过支气管扩张药物或通过时间的推移(在除去引起收缩的刺激物之后)逆转。然而,哮喘长期表现为平滑肌的炎症,肥大或过度兴奋。Chronic obstructive pulmonary disease (COPD) is a common preventable and treatable disease characterized by persistent airflow limitation, progressive development of airflow limitation, and airway and lung response to toxic particles or gases associated with an enhanced chronic inflammatory response. The hallmark of asthma is an acute attack of dyspnea caused by acute constriction of the smooth muscle lining the bronchi (the air passages of the lungs), reducing airway diameter and increasing airflow resistance. Bronchoconstriction in asthma is "reversible" in that acute constriction can be reversed by bronchodilator drugs or over time (after removal of the stimulus that caused the constriction). However, asthma is chronically manifested by inflammation, hypertrophy or hyperactivity of smooth muscle.
目前主要的治疗方式是药物治疗、康复治疗、肺减容术、或外科手术治疗(如使用外科手术切除肺神经,使神经的功能全部或部分无效,可以改善哮喘或肺气肿),这些治疗方法,或治疗效果不明显,或会产生严重的并发症。At present, the main treatment methods are drug therapy, rehabilitation therapy, lung volume reduction surgery, or surgical treatment (such as surgical removal of the pulmonary nerve, which can completely or partially invalidate the function of the nerve, which can improve asthma or emphysema). method, or the therapeutic effect is not obvious, or serious complications may occur.
有研究表明,损伤肺部迷走神经,可以抑制乙酰胆碱释放,抑制平滑肌收缩,进而改善哮喘、COPD症状,改善肺功能。随着冷冻消融技术的发展及应用的普及,冷冻消融为治疗COPD提供了新的思路和方法。由于上述冷冻消融的特点及优势,使得其更适合用于气道组织,更适合用于肺迷走神经消融、损伤,因此冷冻消融是用于肺迷走神经损伤建模的一种合适的方法。Studies have shown that damage to the vagus nerve in the lungs can inhibit the release of acetylcholine and smooth muscle contraction, thereby improving the symptoms of asthma and COPD, and improving lung function. With the development and popularization of cryoablation technology, cryoablation provides new ideas and methods for the treatment of COPD. Due to the above characteristics and advantages of cryoablation, it is more suitable for airway tissue and more suitable for ablation and injury of pulmonary vagus nerve. Therefore, cryoablation is a suitable method for modeling of pulmonary vagus nerve injury.
目前现有的冷冻消融导管的冷冻部位大多为球囊或探头,整个球囊或探头接触部位为其损伤范围,使用该方式目标组织时,整个冷冻部位均无区别的对组织进行消融、损伤,会带来较大的非必要的损伤。例如中国专利CN201710816284.5公开了一种带绝热囊体的冷冻消融导管,其包括:管体和冷冻单元,所述管体包括沿其轴向延伸的冷源进气腔、冷源回气腔及充盈腔,所述冷冻单元设置在所述管体远端部分,包括与所述冷源进气腔和所述冷源回气腔流体连通的第一囊体和与所述充盈腔连通的绝热囊体,当所述第一囊体扩张时,通过充盈腔,向所述绝热囊体内充入绝热介质,使得绝热囊体所占区域成为隔离能量传输的区域,实现阻止所述冷冻单元向绝热区域相对应空间的能量传递,虽然该专利设置了隔离能量的绝热囊体,但其用于消融的第一囊体仍为整体形势,其仍存在损伤范围大而引起的较大的非必要的损伤的问题。At present, most of the frozen parts of the existing cryoablation catheters are balloons or probes, and the entire contact part of the balloon or probe is its damage range. When using this method to target tissue, the entire frozen part will ablate and damage the tissue without distinction. It will cause greater unnecessary damage. For example, Chinese patent CN201710816284.5 discloses a cryoablation catheter with a thermal insulation capsule, which includes: a tube body and a freezing unit, and the tube body includes a cold source inlet cavity and a cold source return cavity extending along its axial direction and a filling chamber, the freezing unit is arranged on the distal part of the tube body, including a first bladder in fluid communication with the cold source inlet chamber and the cold source return air chamber and a first bladder communicating with the filling chamber The thermal insulation capsule, when the first capsule expands, fills the thermal insulation capsule with an insulating medium through the filling cavity, so that the area occupied by the thermal insulation capsule becomes an area that isolates energy transmission, thereby preventing the freezing unit from moving to The energy transfer in the space corresponding to the heat-insulating area, although the patent sets up a heat-insulating capsule for energy isolation, the first capsule used for ablation is still in the overall form, and there is still a large unnecessary damage caused by a large damage range. problem of damage.
发明内容Contents of the invention
为了克服现有技术中所存在的缺点与不足,本发明提供一种冷冻消融导管及其相关的应用,该冷冻消融导管在冷冻部位设置有消融区域、隔热区域,消融区域轴向方向上的长度尽量短,成扁平型(由于有较大的腔体用于充分热交换,可以保证冷冻深度),形成径向方向的扁平损伤,可以有效减少非必要组织损伤;隔热区域可以阻止冷冻介质的冷量传递,进一步减少对非必要组织的损伤,实现尽量少的损伤下,彻底消融目标组织,尤其适用于肺迷走神经组织。In order to overcome the shortcomings and deficiencies in the prior art, the present invention provides a cryoablation catheter and its related applications. The cryoablation catheter is provided with an ablation area and a heat insulation area at the frozen site. The length is as short as possible and flattened (because there is a large cavity for sufficient heat exchange, the freezing depth can be guaranteed), forming flat damage in the radial direction, which can effectively reduce unnecessary tissue damage; the heat insulation area can prevent freezing medium The cold transfer can further reduce the damage to unnecessary tissues, and realize the complete ablation of the target tissue with as little damage as possible, especially suitable for the lung vagus nerve tissue.
为实现上述目的,本发明采用如下技术方案:To achieve the above object, the present invention adopts the following technical solutions:
本发明的第一个方面是提供一种冷冻消融导管,包括可扩张构件和与所述可扩张构件连接的管路,所述可扩张构件上设置隔热区域和消融区域,所述管路包括进气管路和回气管路,所述进气管路、回气管路均与所述可扩张构件的内腔室连通。The first aspect of the present invention is to provide a cryoablation catheter, which includes an expandable member and a pipeline connected to the expandable member. The expandable member is provided with a thermal insulation area and an ablation area, and the pipeline includes An air intake pipeline and a return air pipeline, both of which are in communication with the inner chamber of the expandable member.
进一步地,所述可扩张构件设置有扩张态和收缩态,冷冻介质由所述进气管路进入所述可扩张构件内,使所述可扩张构件成扩张态,所述隔热区域隔离冷冻介质的冷量传递,所述消融区域实现冷量传递进行冷冻消融,达到治疗的目的,冷冻介质通过所述回气管路回流。Further, the expandable member is provided with an expanded state and a contracted state, the refrigerated medium enters the expandable member through the air inlet pipeline, making the expandable member enter the expanded state, and the thermal insulation area isolates the refrigerated medium The cold transfer in the ablation area realizes cold transfer for cryoablation to achieve the purpose of treatment, and the freezing medium flows back through the return air pipeline.
进一步地,所述进气管路的端部延伸入所述可扩张构件,其远端与所述可扩张构件的远端固定密封连接,在所述可扩张构件内部的进气管路上开设至少1个出气口,。更进一步地,所述进气管路在轴向的同一平面位置开设至少2个对称分布的出气口,或者所述进气管路在轴向的不同平面位置各开设至少1个出气口。Further, the end of the air intake pipeline extends into the expandable member, and its distal end is fixedly and sealingly connected with the distal end of the expandable member, and at least one air intake pipeline is opened inside the expandable member. outlet,. Furthermore, at least two symmetrically distributed air outlets are opened on the same axial plane position of the air intake pipeline, or at least one air outlet is respectively opened on different axial plane positions of the air intake pipeline.
进一步地,所述回气管路套设于所述进气管路的外部或所述回气管路(22)与所述进气管路(21)并排设置,所述回气管路(22)的远端与所述可扩张构件的近端固定连接,且与所述可扩张构件的内腔室连通。Further, the air return pipeline is sleeved outside the air intake pipeline or the air return pipeline (22) is arranged side by side with the air intake pipeline (21), and the far end of the air return pipeline (22) It is fixedly connected with the proximal end of the expandable member and communicates with the inner chamber of the expandable member.
进一步地,所述可扩张构件上沿圆周方向设置温度传感器和/或压力传感器。温度传感器和/或压力传感器的类型为本领域常规使用的任一合适的传感器,其中,温度传感器用于实时监测可扩张构件的表面温度;压力传感器用于实时监测可扩张构件对气道壁的压力。Further, temperature sensors and/or pressure sensors are arranged on the expandable member along the circumferential direction. The type of temperature sensor and/or pressure sensor is any suitable sensor conventionally used in the art, wherein, temperature sensor is used for real-time monitoring the surface temperature of expandable member; Pressure sensor is used for real-time monitoring expandable member to airway wall pressure.
进一步地,所述管路的远端的外表面设置至少1条刻度线。更进一步地,所述刻度线为印刷刻度线或者雕刻刻度线,上述刻度线用于丈量距离。Further, at least one scale line is provided on the outer surface of the distal end of the pipeline. Furthermore, the scale lines are printed scale lines or engraved scale lines, and the above scale lines are used for measuring distances.
进一步地,所述隔热区域的壁厚大于所述消融区域的壁厚。其中,2个区域的材质可相同也可不同,从热传递角度看壁厚较厚的区域传热效果比壁厚薄的区域差,即隔热区域可以起到一定的绝热效果。Further, the wall thickness of the thermal insulation area is greater than the wall thickness of the ablation area. Among them, the materials of the two areas can be the same or different. From the perspective of heat transfer, the heat transfer effect of the area with thicker wall thickness is worse than that of the area with thin wall thickness, that is, the heat insulation area can play a certain heat insulation effect.
进一步地,所述隔热区域和消融区域的壁厚相同,所述隔热区域使用热传导系数低的材质,所述消融区域使用热传导系数高的材质。可理解的是,上述材质可为本领域常规使用的任一合适的材质,例如热传导系数低的材质为聚氯乙烯,其导热系数:0.14W/m×K;热传导系数高的材质为聚酰胺,其导热系数:0.25W/m×K。Further, the wall thicknesses of the thermal insulation area and the ablation area are the same, the thermal insulation area uses a material with a low thermal conductivity, and the ablation area uses a material with a high thermal conductivity. It can be understood that the above-mentioned material can be any suitable material conventionally used in this field, for example, the material with low thermal conductivity is polyvinyl chloride, and its thermal conductivity: 0.14W/m×K; the material with high thermal conductivity is polyamide , Its thermal conductivity: 0.25W/m×K.
进一步地,所述隔热区域使用中间层材质为带气孔隔热材质的多层结构。可理解的是,上述带气孔隔热材质可为本领域常规使用的任一合适的材质,例如隔热材料使用的多数高分子材料是做成多孔性的,如:高发泡聚丙烯、发泡聚苯乙烯、聚氨酯泡沫塑料等。Further, the heat insulation area uses a multi-layer structure in which the middle layer material is a heat insulation material with air holes. It can be understood that the above-mentioned thermal insulation material with air holes can be any suitable material conventionally used in this field. For example, most polymer materials used in thermal insulation materials are made porous, such as: high foaming polypropylene, foam Polystyrene, polyurethane foam, etc.
进一步地,所述消融区域的外径大于所述隔热区域的外径。更进一步地,所述消融区域的外径为隔热区域的外径的1.05~1.5倍;更优选地,所述消融区域的外壁为朝外凸起的半球形或近似半球形结构。Further, the outer diameter of the ablation area is larger than the outer diameter of the thermal insulation area. Furthermore, the outer diameter of the ablation area is 1.05 to 1.5 times the outer diameter of the heat insulation area; more preferably, the outer wall of the ablation area is a hemispherical or approximately hemispherical structure protruding outward.
进一步地,所述消融区域为1个或多个,所述消融区域沿轴向方向位于不同平面,其将可扩张构件分隔为径向方向上交错分布的消融区域和隔热区域。Further, there are one or more ablation areas, and the ablation areas are located in different planes along the axial direction, which separate the expandable member into ablation areas and heat insulation areas that are distributed in a radial direction.
本发明的第二个方面是提供一种含有任一上述的冷冻消融导管的冷冻消融装置,其中该冷冻消融装置包括本领域常规使用的冷冻介质输送装置,其与所述进气管路连通,还包括本领域常规使用的冷冻介质回流装置,其与所述回气管路连通;另外其还包括本领域常规使用的冷冻消融导管导向装置和定位装置等。The second aspect of the present invention is to provide a cryoablation device containing any one of the above-mentioned cryoablation catheters, wherein the cryoablation device includes a freezing medium delivery device commonly used in the art, which communicates with the air inlet pipeline, and It includes a freezing medium return device conventionally used in the field, which communicates with the air return pipeline; in addition, it also includes a guide device and a positioning device for a cryoablation catheter conventionally used in the field.
本发明的第三个方面是提供一种任一上述的冷冻消融导管在构建肺部迷走神经损伤模型中的应用,其中,该肺部迷走神经损伤模型为离体肺组织迷走神经损伤模型,所述离体肺组织来源于大型动物,例如牛、羊、猪等。The third aspect of the present invention is to provide an application of any one of the above-mentioned cryoablation catheters in constructing a pulmonary vagus nerve injury model, wherein the pulmonary vagus nerve injury model is an isolated lung tissue vagus nerve injury model, and the isolated Lung tissue is derived from large animals, such as cattle, sheep, and pigs.
本发明的第四个方面是一种采用任一上述的冷冻消融导管进行肺部迷走神经损伤的方法,其包括以下步骤:明确靶组织位置;引入冷冻消融装置的可扩张构件并将其推送至靶组织;确认可扩张构件的消融区域与靶组织吻合;输入冷冻介质,使所述可扩张构件成扩张态,开启冷冻消融程序,对指定部位进行冷冻消融,以完成损伤肺部迷走神经。The fourth aspect of the present invention is a method for pulmonary vagus nerve injury using any one of the above-mentioned cryoablation catheters, which includes the following steps: determining the location of the target tissue; introducing the expandable member of the cryoablation device and pushing it to the target Tissue; Confirm that the ablation area of the expandable component coincides with the target tissue; Input the freezing medium to make the expandable component into an expanded state, start the cryoablation procedure, and perform cryoablation on the designated part to complete the injury of the vagus nerve in the lung.
进一步地,上述靶组织为离体肺组织。Further, the above-mentioned target tissue is isolated lung tissue.
进一步地,所述肺部迷走神经损伤的方法包括如下步骤:明确离体肺组织的靶向位置;在内窥镜监视下,引入所述冷冻消融导管,所述冷冻消融导管包括可扩张构件和与所述可扩张构件近端连接的管路,所述可扩张构件设置有扩张态和收缩态,推送所述冷冻消融导管到达靶组织,并使所述冷冻消融导管的远端向远侧延伸超出内窥镜的远端部分;确认损伤部位与靶组织吻合;输入冷冻介质,使所述可扩张构件成扩张态开启冷冻消融程序,所述冷冻消融程序包括冷冻消融过程和复温过程,对指定部位进行冷冻消融,达到损伤肺部迷走神经目的。Further, the method for lung vagus nerve injury includes the following steps: determining the target position of the isolated lung tissue; introducing the cryoablation catheter under endoscopic monitoring, and the cryoablation catheter includes an expandable member and a tubing connected to a proximal end of the expandable member configured to have an expanded state and a contracted state, pushes the cryoablation catheter to target tissue, and extends the distal end of the cryoablation catheter distally beyond The distal part of the endoscope; confirm that the damaged part coincides with the target tissue; input the freezing medium, make the expandable member into an expanded state and start the cryoablation procedure, the cryoablation procedure includes a cryoablation process and a rewarming process, and the specified Cryoablation is performed on the site to achieve the purpose of damaging the vagus nerve of the lung.
进一步地,所述靶组织,可以为多个靶组织,可以但不限于为左主支气管、右主支气管,或同时包括左、右主支气管。Further, the target tissue may be a plurality of target tissues, which may be, but not limited to, the left main bronchus, the right main bronchus, or both the left and right main bronchus.
进一步地,所述靶组织,可以在一次全部进行冷冻消融,也可以分多次进行冷冻消融。Further, the target tissue may be cryoablated all at once, or may be cryoablated several times.
进一步地,所述将内窥镜引入步骤,可以结合肺部导航技术。Further, the step of introducing the endoscope may be combined with lung navigation technology.
进一步地,引入所述冷冻消融导管步骤,可以是经所述内窥镜本身的通道引入,也可以是所述冷冻消融导管与所述内窥镜并列引入。Further, the step of introducing the cryoablation catheter may be introduced through the channel of the endoscope itself, or the cryoablation catheter may be introduced in parallel with the endoscope.
进一步地,所述确认手术部位与靶组织吻合步骤,可以直视观察,也可以结合多种检测方法,如X光机。Further, the step of confirming that the surgical site matches the target tissue can be observed directly, or can be combined with various detection methods, such as X-ray machine.
进一步地,开启冷冻消融程序,所述冷冻消融程序包括冷冻消融过程和复温过程,对指定部位进行冷冻消融,达到损伤肺部迷走神经的目的,可以对同一个靶组织多重复冷冻消融损伤,以达到更好的冷冻消融损伤效果。Further, start the cryoablation procedure, the cryoablation procedure includes the cryoablation process and the rewarming process, and perform cryoablation on the designated part to achieve the purpose of injuring the lung vagus nerve, and the same target tissue can be repeatedly injured by cryoablation, so as to To achieve a better effect of cryoablation injury.
进一步地,所述冷冻介质为液氮,也可为其他合适的冷冻介质。Further, the freezing medium is liquid nitrogen, or other suitable freezing medium.
本发明采用上述技术方案,具有如下技术效果:The present invention adopts above-mentioned technical scheme, has following technical effect:
1.使用内窥镜配合冷冻消融的介入方法,在达到损伤肺部迷走神经的同时,实现创伤小、手术时间短、操作简单、安全性高,同时有效控制手术的并发症;1. Using the interventional method of endoscope combined with cryoablation, while achieving damage to the vagus nerve in the lungs, it achieves small trauma, short operation time, simple operation, high safety, and effectively controls surgical complications;
2.可扩张构件上设置有隔热区域、消融区域,由于可扩张构件的较大内腔用于充分热交换,消融区域在轴向上的长度可以较短,既能实现肺部迷走神经的损伤,又能尽量减少非必要组织的损伤;2. The expandable member is provided with a heat insulation area and an ablation area. Since the large lumen of the expandable member is used for sufficient heat exchange, the length of the ablation area in the axial direction can be shorter, which can realize the damage of the vagus nerve in the lungs. , and minimize unnecessary tissue damage;
3.冷冻装置上设置有隔热区域,在消融过程中,隔离冷量传递,进一步保护非必要损伤组织;3. The freezing device is equipped with a thermal insulation area, which isolates the transfer of cold energy during the ablation process and further protects unnecessary damaged tissues;
4.消融区域的中心截面沿轴向方向可为不同平面,即沿轴向间断分布,形成轴向上间断损伤(非完整的圆周损伤),间断损伤可以减少对气道壁组织的损伤刺激,不易引起穿孔、气道塌陷等并发症,同时又可以保证肺部迷走神经损伤,阻挡神经传导。4. The central cross-section of the ablation area can be in different planes along the axial direction, that is, the discontinuous distribution along the axial direction forms intermittent damage in the axial direction (incomplete circumferential damage). The discontinuous damage can reduce the damage stimulation to the airway wall tissue, It is not easy to cause complications such as perforation and airway collapse, and at the same time, it can ensure the damage of the vagus nerve in the lungs and block nerve conduction.
附图说明Description of drawings
图1为本发明一实施例中冷冻消融导管的结构示意图。Fig. 1 is a schematic structural diagram of a cryoablation catheter in an embodiment of the present invention.
图2为本发明一实施例中冷冻消融导管的剖视图。Fig. 2 is a cross-sectional view of the cryoablation catheter in an embodiment of the present invention.
图3为图2所示的冷冻消融导管的A处放大图。Fig. 3 is an enlarged view at A of the cryoablation catheter shown in Fig. 2 .
图4为本发明另一实施例中冷冻消融导管的剖视图。Fig. 4 is a cross-sectional view of a cryoablation catheter in another embodiment of the present invention.
图5为本发明另一实施例中冷冻消融导管的剖视图。Fig. 5 is a cross-sectional view of a cryoablation catheter in another embodiment of the present invention.
图6为本发明另一实施例中冷冻消融导管的剖视图。Fig. 6 is a cross-sectional view of a cryoablation catheter in another embodiment of the present invention.
图7为本发明另一实施例中冷冻消融导管的剖视图。Fig. 7 is a cross-sectional view of a cryoablation catheter in another embodiment of the present invention.
图8为本发明另一实施例中冷冻消融导管的剖视图。Fig. 8 is a cross-sectional view of a cryoablation catheter in another embodiment of the present invention.
其中,附图标记为:Wherein, reference sign is:
可扩张构件1;隔热区域11;消融区域12;管路2;进气管路21;回气管路22;刻度线23;出气口211。Expandable member 1 ; heat insulation area 11 ; ablation area 12 ; pipeline 2 ; air inlet pipeline 21 ; air return pipeline 22 ;
具体实施方式Detailed ways
本发明涉及一种冷冻消融导管,包括可扩张构件和与所述可扩张构件连接的管路,所述可扩张构件上设置隔热区域和消融区域,所述管路包括进气管路和回气管路,所述进气管路、回气管路均与所述可扩张构件的内腔室连通。本发明还涉及上述冷冻消融导管的应用。The present invention relates to a cryoablation catheter, comprising an expandable member and a pipeline connected to the expandable member, a thermal insulation area and an ablation area are set on the expandable member, and the pipeline includes an air inlet pipeline and a return air pipe The air inlet pipeline and the air return pipeline are both in communication with the inner chamber of the expandable member. The present invention also relates to the application of the above-mentioned cryoablation catheter.
下面结合附图和实施例,对本发明的具体实施方式作进一步描述。以下实施例仅用于更加清楚地说明本发明的技术方案,而不能以此来限制本发明的保护范围。The specific implementation manners of the present invention will be further described below in conjunction with the drawings and examples. The following examples are only used to illustrate the technical solution of the present invention more clearly, but not to limit the protection scope of the present invention.
实施例1Example 1
本实施例为一较佳结构形式的的冷冻消融导管。如图1~3所示,本实施例所述的冷冻消融导管包括可扩张构件1和与所述可扩张构件1近端连接的管路2,可扩张构件1上设置有位于两侧的隔热区域11和位于中部的消融区域12,所述隔热区域11和消融区域12共同组成所述可扩张构件1,所述可扩张构件1的主体为圆柱体形式,两端分别为圆锥体形式的密封结构,所述消融区域12为360°的环形带形式,其消融区域12的数量为1个,其宽度约为可扩张构件1主体长度的1/4~1/3;其中,所述隔热区域11和消融区域12的材质相同,具体可为聚酰胺材质,但隔热区域11的壁厚大于消融区域12的壁厚,具体约为2~4倍,从热传递角度看壁厚较厚的区域传热效果比壁厚薄的区域差,即隔热区域11可以起到一定的绝热效果。This embodiment is a cryoablation catheter with a preferred structure. As shown in Figures 1 to 3, the cryoablation catheter described in this embodiment includes an expandable member 1 and a pipeline 2 connected to the proximal end of the expandable member 1. The expandable member 1 is provided with partitions on both sides. The thermal region 11 and the ablation region 12 located in the middle, the heat insulation region 11 and the ablation region 12 together constitute the expandable member 1, the main body of the expandable member 1 is in the form of a cylinder, and the two ends are respectively in the form of cones The sealing structure, the ablation area 12 is in the form of a 360° annular band, the number of the ablation area 12 is one, and its width is about 1/4 to 1/3 of the length of the main body of the expandable member 1; wherein, the The heat insulation area 11 and the ablation area 12 are made of the same material, specifically polyamide, but the wall thickness of the heat insulation area 11 is greater than the wall thickness of the ablation area 12, specifically about 2 to 4 times. From the perspective of heat transfer, the wall thickness The heat transfer effect of the thicker area is worse than that of the thinner area, that is, the heat insulation area 11 can play a certain heat insulation effect.
在本实施例中,管路2包括分别与可扩张构件1的内腔室连通的进气管路21和回气管路22,进气管路21的端部延伸入可扩张构件1,其远端与可扩张构件1的远端固定密封连接,在可扩张构件1内部位于中间位置的进气管路21的侧壁上开设对称分布的2个出气口211,回气管路22套设于进气管路21的外部,其远端与所述可扩张构件的近端固定连接,具体结构为从可扩张构件1的近端的圆锥形端部延伸出密封套设于回气管路22外部的套管,回气管路22的远端在可扩张构件1的近端处与其内腔室连通。In this embodiment, the pipeline 2 includes an air inlet pipeline 21 and a gas return pipeline 22 respectively communicated with the inner chamber of the expandable member 1, the end of the air inlet pipeline 21 extends into the expandable member 1, and its distal end is connected to The distal end of the expandable member 1 is fixed and sealed, and two symmetrically distributed air outlets 211 are provided on the side wall of the air intake pipeline 21 located in the middle of the expandable member 1, and the return air pipeline 22 is sleeved on the air intake pipeline 21 The outer part, the distal end of which is fixedly connected with the proximal end of the expandable member, and the specific structure is that a sleeve extending from the conical end of the proximal end of the expandable member 1 is sealed and sleeved on the outside of the return air pipeline 22, and the return The distal end of the airway 22 communicates with the internal lumen of the expandable member 1 at its proximal end.
在本实施例中,回气管路22的远端的外表面设置至少1条刻度线23,该刻度线23为印刷刻度线或者雕刻刻度线,可扩张构件1上沿圆周方向设置温度传感器和压力传感器。In this embodiment, at least one scale line 23 is provided on the outer surface of the distal end of the air return pipeline 22, and the scale line 23 is a printed scale line or an engraved scale line. sensor.
在本实施例中,可扩张构件1设置有扩张态和收缩态,冷冻介质(例如液氮)由进气管路21侧壁开设的出气口211进入可扩张构件1内,使可扩张构件1成扩张态,隔热区域11隔离冷冻介质的冷量传递,消融区域12实现冷量传递进行冷冻消融,达到治疗的目的,冷冻介质通过回气管路22回流。In this embodiment, the expandable member 1 is provided with an expanded state and a contracted state, and the refrigerated medium (such as liquid nitrogen) enters the expandable member 1 through the air outlet 211 provided on the side wall of the inlet pipeline 21, so that the expandable member 1 becomes In the expanded state, the thermal insulation area 11 isolates the cold energy transfer of the freezing medium, and the ablation area 12 realizes cold energy transfer for cryoablation to achieve the purpose of treatment, and the freezing medium flows back through the air return line 22 .
实施例2Example 2
本实施例为另一较佳结构形式的冷冻消融导管。如图4所示,本实施例所述的冷冻消融导管结构与实施例1基本相同,其不同之处仅在于:隔热区域11和消融区域12具有相同的壁厚,但两者采用的材质不同,隔热区域11使用热传导系数低的材质,具体为聚氯乙烯材质;消融区域12使用热传导系数高的材质,具体为聚酰胺材质。This embodiment is another preferred structural form of the cryoablation catheter. As shown in Figure 4, the structure of the cryoablation catheter described in this embodiment is basically the same as that of Embodiment 1, the only difference is that the heat insulation area 11 and the ablation area 12 have the same wall thickness, but the materials used in both Differently, the heat insulation area 11 is made of a material with a low thermal conductivity, specifically polyvinyl chloride; the ablation area 12 is made of a material with a high thermal conductivity, specifically polyamide.
实施例3Example 3
本实施例为另一较佳结构形式的冷冻消融导管。如图5所示,本实施例所述的冷冻消融导管结构与实施例1基本相同,其不同之处仅在于:隔热区域11和消融区域12具有相同的壁厚,且两者采用的材质可相同也可不同,消融区域12的外径大于隔热区域11的外径,具体为消融区域12的外壁为朝外凸起的半球形或近似半球形结构,消融区域12的外径为隔热区域11的外径的1.05~1.5倍。在本实施例中,在可扩张构件1处于扩张状态时,由于消融区域12的外径较大,从而其会优先与待损伤部位进行接触,从而实现局部冷冻消融的目的。This embodiment is another preferred structural form of the cryoablation catheter. As shown in Figure 5, the structure of the cryoablation catheter described in this embodiment is basically the same as that of Embodiment 1, the only difference is that the heat insulation area 11 and the ablation area 12 have the same wall thickness, and the materials used in both It can be the same or different. The outer diameter of the ablation area 12 is greater than the outer diameter of the heat insulation area 11. Specifically, the outer wall of the ablation area 12 is a hemispherical or approximately hemispherical structure that protrudes outward. The outer diameter of the ablation area 12 is 1.05 to 1.5 times the outer diameter of the hot zone 11 . In this embodiment, when the expandable member 1 is in the expanded state, since the outer diameter of the ablation region 12 is relatively large, it will preferentially contact the site to be damaged, thereby achieving the purpose of local cryoablation.
实施例4Example 4
本实施例为另一较佳结构形式的冷冻消融导管。如图6所示,本实施例所述的冷冻消融导管结构与实施例1基本相同,其不同之处仅在于:隔热区域11和消融区域12的外径相同,且具有相同或不同的壁厚,两者采用的材质可相同也可不同,当壁厚不同时,隔热区域11的壁厚大于消融区域12的壁厚;当材质不同时,隔热区域11使用热传导系数低的材质,具体为聚氯乙烯材质,且隔热区域使用中间层材质为带气孔隔热材质的多层结构;消融区域12使用热传导系数高的材质,具体为聚酰胺材质;另外,消融区域12的数量为2个,其均为360°环形带形式,与各消融区域12对应的进气管路21的侧壁上均开设对称分布的2个出气口211,消融区域12与隔热区域11间隔分布。This embodiment is another preferred structural form of the cryoablation catheter. As shown in Figure 6, the structure of the cryoablation catheter described in this embodiment is basically the same as that of Embodiment 1, the only difference is that the outer diameters of the thermal insulation area 11 and the ablation area 12 are the same, and have the same or different walls thickness, the materials used by the two can be the same or different, when the wall thickness is different, the wall thickness of the heat insulation area 11 is greater than the wall thickness of the ablation area 12; when the materials are different, the heat insulation area 11 uses a material with a low thermal conductivity, Specifically, it is made of polyvinyl chloride, and the material of the heat insulation area is a multi-layer structure with a heat insulation material with pores; the ablation area 12 is made of a material with high thermal conductivity, specifically polyamide material; in addition, the number of ablation areas 12 is Two of them are in the form of 360° annular bands. Two symmetrically distributed air outlets 211 are provided on the side wall of the intake pipeline 21 corresponding to each ablation area 12 . The ablation area 12 and the heat insulation area 11 are spaced apart.
实施例5Example 5
本实施例为另一较佳结构形式的冷冻消融导管。如图7所示,本实施例所述的冷冻消融导管结构与实施例1基本相同,其不同之处仅在于:隔热区域11和消融区域12具有相同或不同的壁厚,两者采用的材质可相同也可不同,当壁厚不同时,隔热区域11的壁厚大于消融区域12的壁厚;当材质不同时,隔热区域11使用热传导系数低的材质,具体为聚氯乙烯材质;消融区域12使用热传导系数高的材质,具体为聚酰胺材质;另外,消融区域12的数量为2个,其均为180°的环形结构形式,各消融区域12沿轴向方向位于不同平面,其将可扩张构件分隔为径向方向上交错分布的消融区域12和隔热区域11,具体为可扩张构件1被分隔为如图7所示的上下对称的两部分,上部分的第一侧为消融区域12,上部分的第二侧为隔热区域11,与上部分第一侧对应的下部分的第一侧为隔热区域11,与上部分第二侧对应的下部分的第二侧为消融区域12,与每一消融区域12对应的进气管路21的侧壁均开设1个或多个出气口。This embodiment is another preferred structural form of the cryoablation catheter. As shown in Figure 7, the structure of the cryoablation catheter described in this embodiment is basically the same as that of Embodiment 1, the only difference is that: the heat insulation area 11 and the ablation area 12 have the same or different wall thicknesses, and the two adopt The materials can be the same or different. When the wall thicknesses are different, the wall thickness of the heat insulation area 11 is greater than that of the ablation area 12; when the materials are different, the heat insulation area 11 uses a material with a low thermal conductivity, specifically polyvinyl chloride. The ablation area 12 is made of a material with a high thermal conductivity, specifically polyamide material; in addition, the number of ablation areas 12 is 2, which are all in the form of a 180° ring structure, and each ablation area 12 is located on a different plane along the axial direction. It divides the expandable member into ablation regions 12 and heat insulation regions 11 that are staggered in the radial direction. Specifically, the expandable member 1 is divided into two symmetrical parts up and down as shown in FIG. 7 , the first side of the upper part is the ablation area 12, the second side of the upper part is the thermal insulation area 11, the first side of the lower part corresponding to the first side of the upper part is the thermal insulation area 11, and the second side of the lower part corresponding to the second side of the upper part The side is the ablation area 12, and the side wall of the air intake pipeline 21 corresponding to each ablation area 12 is provided with one or more air outlets.
实施例6Example 6
本实施例为另一较佳结构形式的冷冻消融导管。如图8所示,本实施例所述的冷冻消融导管结构与实施例1基本相同,其不同之处仅在于:隔热区域11和消融区域12具有相同或不同的壁厚,两者采用的材质可相同也可不同,当壁厚不同时,隔热区域11的壁厚大于消融区域12的壁厚;当材质不同时,隔热区域11使用热传导系数低的材质,具体为聚氯乙烯材质;消融区域12使用热传导系数高的材质,具体为聚酰胺材质;且消融区域12的数量为2个,其均为180°的环形带形式,且消融区域12的外径大于隔热区域11的外径,具体为消融区域12的外壁为朝外凸起的半球形或近似半球形结构,各消融区域12沿轴向方向位于不同平面,其将可扩张构件分隔为交错分布的消融区域12和隔热区域11,具体为可扩张构件被分隔为如图8所示的左右对称的两部分,左部分由上至下分为隔热区域11、消融区域12和隔热区域11,右部分由上至下分为隔热区域11、消融区域12和隔热区域11,但左右两部分的消融区域12不在同一平面上,与每一消融区域12对应的进气管路21的侧壁均开设1个出气口。This embodiment is another preferred structural form of the cryoablation catheter. As shown in Figure 8, the structure of the cryoablation catheter described in this embodiment is basically the same as that of Embodiment 1, the only difference is that: the heat insulation area 11 and the ablation area 12 have the same or different wall thicknesses, and the two adopt The materials can be the same or different. When the wall thicknesses are different, the wall thickness of the heat insulation area 11 is greater than that of the ablation area 12; when the materials are different, the heat insulation area 11 uses a material with a low thermal conductivity, specifically polyvinyl chloride. ; The ablation area 12 is made of a material with high thermal conductivity, specifically polyamide material; and the number of ablation areas 12 is 2, which are all in the form of 180° annular bands, and the outer diameter of the ablation area 12 is larger than that of the heat insulation area 11 The outer diameter, specifically the outer wall of the ablation area 12 is a hemispherical or approximately hemispherical structure protruding outward, and each ablation area 12 is located in a different plane along the axial direction, which separates the expandable member into staggered ablation areas 12 and The thermal insulation area 11, specifically, the expandable member is divided into two symmetrical parts as shown in FIG. From top to bottom, it is divided into heat insulation area 11, ablation area 12 and heat insulation area 11, but the left and right ablation areas 12 are not on the same plane, and the side walls of the intake pipeline 21 corresponding to each ablation area 12 are opened with 1 an outlet.
实施例7Example 7
本实施例为采用实施例1~6中任一项所述的冷冻消融导管进行肺部迷走神经损伤的方法,其包括如下步骤:明确离体肺组织的靶向位置;在内窥镜监视下,引入冷冻消融导管,冷冻消融导管包括可扩张构件和与可扩张构件近端连接的管路,可扩张构件设置有扩张态和收缩态,推送所述冷冻消融导管到达靶组织,并使冷冻消融导管的远端向远侧延伸超出内窥镜的远端部分;确认损伤部位与靶组织吻合;输入冷冻介质,使可扩张构件成扩张态,开启冷冻消融程序,冷冻消融程序包括冷冻消融过程和复温过程,对指定部位进行冷冻消融,达到损伤肺部迷走神经目的。This embodiment is a method of using the cryoablation catheter described in any one of Embodiments 1 to 6 to injure the pulmonary vagus nerve, which includes the following steps: clarifying the target position of the isolated lung tissue; under endoscopic monitoring, Introducing a cryoablation catheter, the cryoablation catheter includes an expandable member and a pipeline connected to the proximal end of the expandable member, the expandable member is provided with an expanded state and a contracted state, pushing the cryoablation catheter to the target tissue, and making the cryoablation catheter The distal end of the endoscope extends farther than the distal part of the endoscope; confirm that the damaged part matches the target tissue; input the freezing medium to make the expandable member into an expanded state, and start the cryoablation procedure. The cryoablation procedure includes cryoablation process and recovery During the warm process, cryoablation is performed on the designated parts to achieve the purpose of damaging the vagus nerve in the lungs.
上述靶组织可为左主支气管、右主支气管,或同时包括左、右主支气管;上述靶组织,可以在一次全部进行冷冻消融,也可以分多次进行冷冻消融;在将内窥镜引入步骤,可以结合肺部导航技术;其中,引入所述冷冻消融导管步骤,可以是经所述内窥镜本身的通道引入,也可以是所述冷冻消融导管与所述内窥镜并列引入;其中,确认手术部位与靶组织吻合步骤,可以直视观察,也可以结合多种检测方法,如X光机;其中,冷冻消融程序包括冷冻消融过程和复温过程,对指定部位进行冷冻消融,达到损伤肺部迷走神经的目的,可以对同一个靶组织多重复冷冻消融损伤,以达到更好的冷冻消融损伤效果。The above-mentioned target tissue can be the left main bronchus, the right main bronchus, or both the left and right main bronchus; the above-mentioned target tissue can be cryoablated all at once, or can be cryoablated several times; , can be combined with lung navigation technology; wherein, the step of introducing the cryoablation catheter can be introduced through the channel of the endoscope itself, or the cryoablation catheter can be introduced side by side with the endoscope; wherein, The step of confirming the coincidence of the surgical site with the target tissue can be observed directly, or can be combined with various detection methods, such as X-ray machines; among them, the cryoablation procedure includes the cryoablation process and the rewarming process, and cryoablation is performed on the designated site to achieve damage The purpose of the lung vagus nerve is to repeat the cryoablation injury to the same target tissue to achieve a better effect of cryoablation injury.
由上述实施例可知,本发明根据肺部气道结构,利用内窥镜,具有创伤小、手术时长短、安全性高的优势;冷冻消融在气道的应用较热消融具有安全性高、对气道壁结构损伤小、不易引起气道狭窄等并发症;使用内窥镜配合冷冻消融方法,在达到损伤神经的同时,有效控制该消融方法的并发症;肺部迷走神经位于气道壁外侧,使用气道内介入冷冻消融方式损伤肺迷走神经时,为了达到神经损伤的效果,本发明采用端部具有可扩张构件的消融导管,其处于扩张状态时具有较大的囊体(腔体)以用于充分冷量热交换,从而使冷冻损伤穿透整个气道壁,在该可扩张构件设置消融和隔热区域以尽量减少非必要组织的损伤。It can be known from the above examples that the present invention uses an endoscope according to the lung airway structure, and has the advantages of less trauma, shorter operation time, and high safety; the application of cryoablation in the airway is safer than thermal ablation, and has the advantages of The damage to the airway wall structure is small, and it is not easy to cause complications such as airway stenosis; the use of endoscope and cryoablation method can effectively control the complications of the ablation method while damaging the nerve; the vagus nerve of the lung is located outside the airway wall, When the lung vagus nerve is injured by intervening cryoablation in the airway, in order to achieve the effect of nerve injury, the present invention adopts an ablation catheter with an expandable member at the end, which has a larger capsule (cavity) in the expanded state for Sufficient cold and heat exchange, so that cryo-injury penetrates the entire airway wall, ablation and thermal insulation zones are placed on the expandable member to minimize unnecessary tissue damage.
以上对本发明的具体实施例进行了详细描述,但其只作为范例,本发明并不限制于以上描述的具体实施例。对于本领域技术人员而言,任何对本发明进行的等同修改和替代也都在本发明的范畴之中。因此,在不脱离本发明的精神和范围下所作的均等变换和修改,都应涵盖在本发明的范围内。The specific embodiments of the present invention have been described in detail above, but they are only examples, and the present invention is not limited to the specific embodiments described above. For those skilled in the art, any equivalent modifications and substitutions to the present invention are also within the scope of the present invention. Therefore, equivalent changes and modifications made without departing from the spirit and scope of the present invention shall fall within the scope of the present invention.
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