CN115998418A - Laser ablation catheter - Google Patents

Abstract

Translated fromChinese

本申请涉及医疗设备技术领域，提供一种激光消融导管，激光消融导管包括管体结构和消融结构，管体结构包括外管，以及设于外管内部的内管；消融结构设于内管和外管之间，且设有至少一个，消融结构包括第一光纤和连接于第一光纤远端的第二光纤，第二光纤的截面积大于第一光纤的截面积，第二光纤用于对第一光纤的出射光进行扩束，并经由扩束光对病变组织进行消融。本申请的激光消融导管，在达到同样消融效果的条件下，可有效地减少消融结构的使用数量，从而可有效地减少激光消融导管的外径尺寸，有效地提高激光消融导管的推送性能和通过性能。

This application relates to the technical field of medical equipment and provides a laser ablation catheter. The laser ablation catheter includes a tube body structure and an ablation structure. The tube body structure includes an outer tube and an inner tube arranged inside the outer tube; Between the outer tubes, at least one is provided. The ablation structure includes a first optical fiber and a second optical fiber connected to the distal end of the first optical fiber. The cross-sectional area of the second optical fiber is larger than that of the first optical fiber. The second optical fiber is used for The outgoing light of the first optical fiber is expanded, and the diseased tissue is ablated through the expanded beam. The laser ablation catheter of the present application can effectively reduce the number of ablation structures used under the condition of achieving the same ablation effect, thereby effectively reducing the outer diameter of the laser ablation catheter and effectively improving the pushing performance and passage of the laser ablation catheter. performance.

Description

Translated fromChinese

激光消融导管laser ablation catheter

技术领域technical field

本申请属于医疗设备技术领域，尤其涉及一种激光消融导管。The application belongs to the technical field of medical equipment, and in particular relates to a laser ablation catheter.

背景技术Background technique

目前，在医疗领域中，为了对血管内的如斑块等病变组织进行治疗，通常通过激光消融导管将激光传输至病变组织以消融病变组织，达到治疗目的。At present, in the medical field, in order to treat diseased tissues such as plaques in blood vessels, laser light is usually transmitted to the diseased tissues through a laser ablation catheter to ablate the diseased tissues to achieve therapeutic purposes.

其中，现有激光消融导管内通常会集成多个消融光纤以保障消融效率，如此，难免致使激光消融导管的外径尺寸较大，从而导致激光消融导管的通过性能较差。Among them, a plurality of ablation optical fibers are usually integrated in the existing laser ablation catheter to ensure the ablation efficiency. In this way, the outer diameter of the laser ablation catheter will inevitably be larger, resulting in poor passing performance of the laser ablation catheter.

发明内容Contents of the invention

本申请的目的在于提供一种激光消融导管，以解决在实际应用中，现有激光消融导管内通常会集成多个消融光纤，如此，难免致使激光消融导管的外径尺寸较大，从而导致激光消融导管的通过性能较差的问题。The purpose of this application is to provide a laser ablation catheter to solve the problem that in practical applications, multiple ablation fibers are usually integrated in the existing laser ablation catheter, so that the outer diameter of the laser ablation catheter will inevitably be larger, resulting in laser ablation The problem of poor passability of the ablation catheter.

为实现上述目的，本申请采用的技术方案是：一种激光消融导管，包括：In order to achieve the above purpose, the technical solution adopted in this application is: a laser ablation catheter, comprising:

管体结构，包括外管，以及设于所述外管内部的内管；a pipe body structure, including an outer pipe, and an inner pipe disposed inside the outer pipe;

消融结构，设于所述内管和所述外管之间，且设有至少一个，所述消融结构包括第一光纤和连接于所述第一光纤远端的第二光纤，所述第二光纤的截面积大于所述第一光纤的截面积，所述第二光纤用于对所述第一光纤的出射光进行扩束，并经由扩束光对病变组织进行消融。An ablation structure is arranged between the inner tube and the outer tube, and at least one is provided, the ablation structure includes a first optical fiber and a second optical fiber connected to the distal end of the first optical fiber, the second The cross-sectional area of the optical fiber is larger than that of the first optical fiber, and the second optical fiber is used to expand the outgoing light of the first optical fiber and ablate the diseased tissue through the expanded beam.

在一个实施例中，所述第一光纤和所述第二光纤之间设有过渡光纤段，所述过渡光纤段的径向尺寸在靠近所述第二光纤的方向上渐扩设置。In one embodiment, a transition fiber segment is provided between the first optical fiber and the second optical fiber, and the radial dimension of the transition fiber segment is gradually expanded in a direction close to the second optical fiber.

在一个实施例中，所述激光消融导管还包括设于所述内管和所述外管之间的调整结构，所述调整结构能够带动所述管体结构的远端和所述消融结构的远端弯曲。In one embodiment, the laser ablation catheter further includes an adjustment structure arranged between the inner tube and the outer tube, and the adjustment structure can drive the distal end of the tube structure and the ablation structure. The distal end is curved.

在一个实施例中，所述激光消融导管还包括第一成像组件和引导结构，所述第一成像组件用于实时成像，所述引导结构用于导引所述管体结构和所述消融结构的移动路径；In one embodiment, the laser ablation catheter further includes a first imaging component and a guiding structure, the first imaging component is used for real-time imaging, and the guiding structure is used to guide the tubular structure and the ablation structure the path of movement;

所述第一成像组件和所述引导结构同时穿设于所述内管中，所述第一成像组件相对于所述内管相对固定，所述第一成像组件不凸出于所述第一光纤的远端端面；The first imaging component and the guiding structure are passed through the inner tube at the same time, the first imaging component is relatively fixed relative to the inner tube, and the first imaging component does not protrude from the first the distal end face of the optical fiber;

或，所述第一成像组件和所述引导结构交替穿设于所述内管中。Or, the first imaging component and the guiding structure are alternately passed through the inner tube.

在一个实施例中，所述第一成像组件和所述引导结构同时穿设于所述内管中，所述内管的内部分隔形成第一管腔和第二管腔，所述第一成像组件穿设于所述第一管腔中，所述引导结构穿梭于所述第二管腔中。In one embodiment, the first imaging component and the guiding structure are simultaneously penetrated in the inner tube, the inner tube is divided to form a first lumen and a second lumen, and the first imaging The components pass through the first lumen, and the guiding structure shuttles through the second lumen.

在一个实施例中，所述第一管腔的中心线偏离所述管体结构的中心线设置。In one embodiment, the centerline of the first lumen is deviated from the centerline of the tubular structure.

在一个实施例中，所述内管的外径在靠近远端的方向渐缩设置。In one embodiment, the outer diameter of the inner tube is tapered toward the distal end.

在一个实施例中，所述第一管腔不凸出于所述第一光纤的远端端面。In one embodiment, the first lumen does not protrude beyond the distal end face of the first optical fiber.

在一个实施例中，所述激光消融导管还包括设于所述外管和所述内管之间的至少一个第二成像组件，所述第二成像组件不凸出于所述第一光纤的远端端面，用于实时成像；In one embodiment, the laser ablation catheter further includes at least one second imaging component disposed between the outer tube and the inner tube, the second imaging component does not protrude beyond the edge of the first optical fiber Distal facet for real-time imaging;

当所述第二成像组件设有多个时，多个所述第二成像组件呈圆周阵列排布。When there are multiple second imaging components, the multiple second imaging components are arranged in a circular array.

在一个实施例中，所述激光消融导管还包括套设于各所述第一光纤外的安装套，各所述第二成像组件分别安装于所述安装套的外周；In one embodiment, the laser ablation catheter further includes a mounting sleeve sleeved on each of the first optical fibers, and each of the second imaging components is respectively mounted on the outer periphery of the mounting sleeve;

当所述第二成像组件设有多个时，所述安装套为多边形管状，各所述第二成像组件分别安装在所述安装套的各侧面。When there are multiple second imaging assemblies, the installation sleeve is polygonal tube shape, and each second imaging assembly is installed on each side of the installation sleeve.

在一个实施例中，所述第二成像组件包括连接于所述安装套背离所述内管一侧的芯片，以及连接于所述芯片背离所述安装套一侧且与所述芯片电连接的至少一个超声换能器。In one embodiment, the second imaging component includes a chip connected to the side of the mounting sleeve away from the inner tube, and a chip connected to the side of the chip facing away from the mounting sleeve and electrically connected to the chip. At least one ultrasound transducer.

在一个实施例中，所述超声换能器设有多个，多个所述超声换能器相互间隔设置。In one embodiment, there are multiple ultrasonic transducers, and the multiple ultrasonic transducers are spaced apart from each other.

在一个实施例中，所述超声换能器为压电微机械超声换能器。In one embodiment, the ultrasound transducer is a piezoelectric micromachined ultrasound transducer.

在一个实施例中，所述外管设有与所述第二成像组件相对设置并将所述外管的内部连通至外部的探测口。In one embodiment, the outer tube is provided with a detection port disposed opposite to the second imaging assembly and communicating the inside of the outer tube to the outside.

在一个实施例中，所述外管的至少与所述第二成像组件相对设置的部分由具有超声耦合特性的材质制成。In one embodiment, at least a portion of the outer tube opposite to the second imaging component is made of a material with ultrasonic coupling properties.

本申请提供的有益效果在于：The beneficial effect that this application provides is:

本申请实施例提供的激光消融导管，通过将消融结构设置为第一光纤和连接于第一光纤远端的第二光纤，以通过第二光纤对第一光纤的出射光进行扩束，如此，在达到同样消融效果的条件下，可有效地减少第一光纤的使用数量，也即可有效地减少消融结构的使用数量，从而可有效地减少激光消融导管的外径尺寸，有效地提高激光消融导管的推送性能和通过性能，同时，通过将消融结构设置于内管和外管之间，以通过管体结构对消融结构进行支撑和保护，有效地提升激光消融导管的柔韧性，有效地降低消融结构容易折断的风险。因此，在保障激光消融导管柔韧性的同时，还有效地减少激光消融导管的外径尺寸，有效地提高激光消融导管的推送性能和通过性能，有效地扩大激光消融导管的消融范围，有效地提高激光消融导管的使用性能。In the laser ablation catheter provided in the embodiment of the present application, the ablation structure is configured as a first optical fiber and a second optical fiber connected to the distal end of the first optical fiber, so that the emitted light of the first optical fiber is expanded through the second optical fiber, thus, Under the condition of achieving the same ablation effect, the number of first optical fibers used can be effectively reduced, that is, the number of ablation structures used can be effectively reduced, thereby effectively reducing the outer diameter of the laser ablation catheter and effectively improving the efficiency of laser ablation. At the same time, by setting the ablation structure between the inner tube and the outer tube to support and protect the ablation structure through the tube structure, the flexibility of the laser ablation catheter can be effectively improved and the laser ablation catheter can be effectively reduced. Risk of easy fracture of the ablation structure. Therefore, while ensuring the flexibility of the laser ablation catheter, the outer diameter of the laser ablation catheter can be effectively reduced, the pushing performance and passing performance of the laser ablation catheter can be effectively improved, the ablation range of the laser ablation catheter can be effectively expanded, and the Performance of laser ablation catheters.

附图说明Description of drawings

为了更清楚地说明本申请实施例中的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the accompanying drawings that need to be used in the embodiments. Obviously, the accompanying drawings in the following description are only some embodiments of the present application. For Those of ordinary skill in the art can also obtain other drawings based on these drawings without making creative efforts.

图1是本申请实施例一提供的激光消融导管的示意图一；Fig. 1 is a schematic diagram 1 of a laser ablation catheter provided in Embodiment 1 of the present application;

图2是本申请实施例一提供的激光消融导管的剖视图一；Fig. 2 is the first cross-sectional view of the laser ablation catheter provided by the first embodiment of the present application;

图3是本申请实施例一提供的激光消融导管的剖视图二；FIG. 3 is a second cross-sectional view of the laser ablation catheter provided in Embodiment 1 of the present application;

图4是本申请实施例一提供的激光消融导管的剖视图三；Fig. 4 is a third cross-sectional view of the laser ablation catheter provided in Embodiment 1 of the present application;

图5是本申请实施例一提供的消融结构的示意图；Fig. 5 is a schematic diagram of the ablation structure provided in Embodiment 1 of the present application;

图6是本申请实施例二提供的激光消融导管的剖视图；Fig. 6 is a cross-sectional view of the laser ablation catheter provided in Embodiment 2 of the present application;

图7是本申请实施例三提供的激光消融导管的剖视图；Fig. 7 is a cross-sectional view of the laser ablation catheter provided in Embodiment 3 of the present application;

图8是本申请实施例五提供的激光消融导管的剖视图。Fig. 8 is a cross-sectional view of the laser ablation catheter provided in Embodiment 5 of the present application.

附图标号说明：Explanation of reference numbers:

10-管体结构；11-外管；111-探测口；12-内管；121-第一管腔；122-第二管腔；20-消融结构；21-第一光纤；22-第二光纤；23-过渡光纤段；30-第一成像组件；40-引导结构；50-调整结构；60-第二成像组件；61-芯片；62-超声换能器；70-安装套；80-密封结构；L1-管体结构的中心线；L2-第一管腔的中心线；a-远端；b-近端。10-tube body structure; 11-outer tube; 111-detection port; 12-inner tube; 121-first lumen; 122-second lumen; 20-ablation structure; 21-first optical fiber; 22-second Optical fiber; 23-transition fiber section; 30-first imaging component; 40-guiding structure; 50-adjusting structure; 60-second imaging component; 61-chip; 62-ultrasonic transducer; 70-installation sleeve; 80- Sealing structure; L1-the centerline of the tubular structure; L2-the centerline of the first lumen; a-distal end; b-proximal end.

具体实施方式Detailed ways

为了使本申请所要解决的技术问题、技术方案及有益效果更加清楚明白，以下结合附图及实施例，对本申请进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本申请，并不用于限定本申请。In order to make the technical problems, technical solutions and beneficial effects to be solved by the present application clearer, the present application will be further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described here are only used to explain the present application, and are not intended to limit the present application.

在本申请的描述中，需要理解的是，术语“长度”、“宽度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。In the description of the present application, it should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", The orientation or positional relationship indicated by "horizontal", "top", "bottom", "inner", "outer", etc. are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the application and simplifying the description, rather than Nothing to indicate or imply that a referenced device or element must have a particular orientation, be constructed, and operate in a particular orientation should therefore not be construed as limiting the application.

此外，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个该特征。在本申请的描述中，“多个”的含义是两个或两个以上，除非另有明确具体的限定。In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, a feature defined as "first" and "second" may explicitly or implicitly include one or more of these features. In the description of the present application, "plurality" means two or more, unless otherwise specifically defined.

在本申请中，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本申请中的具体含义。In this application, terms such as "installation", "connection", "connection" and "fixation" should be interpreted in a broad sense, for example, it can be a fixed connection or a detachable connection, unless otherwise clearly specified and limited. , or integrated; it can be mechanically connected or electrically connected; it can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two components or the interaction relationship between two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application according to specific situations.

请参阅图2、图3，在本申请中，近端b均为靠近操作人员的一端，远端a均为远离操作人员的一端。Please refer to Fig. 2 and Fig. 3. In this application, the proximal end b is the end close to the operator, and the distal end a is the end far away from the operator.

以下结合具体实施例对本申请的具体实现进行更加详细的描述：The specific implementation of the present application is described in more detail below in conjunction with specific embodiments:

实施例一Embodiment one

请参阅图1、图2，本申请实施例提供了一种激光消融导管，包括管体结构10和消融结构20。Referring to FIG. 1 and FIG. 2 , the embodiment of the present application provides a laser ablation catheter, which includes atube structure 10 and anablation structure 20 .

其中，管体结构10包括外管11，以及设于外管11内部的内管12。消融结构20设于内管12和外管11之间，且设有至少一个，消融结构20包括第一光纤21和连接于第一光纤21远端的第二光纤22，第二光纤22的截面积大于第一光纤21的截面积，第二光纤22用于对第一光纤21的出射光进行扩束，并经由扩束光对病变组织进行消融。其中，第一光纤21的截面积为垂直于其中心线的截面的面积。其中，第二光纤22的截面积为垂直于其中心线的截面的面积。Wherein, thetube body structure 10 includes anouter tube 11 and aninner tube 12 disposed inside theouter tube 11 . Theablation structure 20 is arranged between theinner tube 12 and theouter tube 11, and at least one is provided. Theablation structure 20 includes a firstoptical fiber 21 and a secondoptical fiber 22 connected to the distal end of the firstoptical fiber 21. The area is larger than the cross-sectional area of the firstoptical fiber 21 , and the secondoptical fiber 22 is used to expand the outgoing light of the firstoptical fiber 21 and ablate the diseased tissue through the expanded beam. Wherein, the cross-sectional area of the firstoptical fiber 21 is the area of the cross-section perpendicular to its centerline. Wherein, the cross-sectional area of the secondoptical fiber 22 is the area of the cross-section perpendicular to its centerline.

基于此，在通过激光消融导管对血管内的病变组织进行消融手术时，先使激光消融导管移动至病变组织位置，随后，通过第二光纤22对第一光纤21的出射光进行扩束，并经由扩束光对病变组织进行消融，即可实现治疗的目的。Based on this, when the laser ablation catheter is used to ablate the diseased tissue in the blood vessel, the laser ablation catheter is first moved to the position of the diseased tissue, and then the emitted light of the firstoptical fiber 21 is expanded through the secondoptical fiber 22, and The purpose of treatment can be achieved by ablation of diseased tissue through expanded beam light.

基于此，通过将消融结构20设置为第一光纤21和连接于第一光纤21远端的第二光纤22，以通过第二光纤22对第一光纤21的出射光进行扩束，如此，在达到同样消融效果的条件下，可有效地减少第一光纤21的使用数量，也即可有效地减少消融结构20的使用数量，从而可有效地减少激光消融导管的外径尺寸，有效地提高激光消融导管的推送性能和通过性能，进而可有效地扩大激光消融导管的消融范围，有效地提高激光消融导管的使用性能。此外，还可有效地降低消融结构20生产成本，进而可有效地降低激光消融导管的生产成本。Based on this, by setting theablation structure 20 as the firstoptical fiber 21 and the secondoptical fiber 22 connected to the far end of the firstoptical fiber 21, the outgoing light of the firstoptical fiber 21 is expanded through the secondoptical fiber 22, so that in Under the condition of achieving the same ablation effect, the number of firstoptical fibers 21 used can be effectively reduced, that is, the number ofablation structures 20 used can be effectively reduced, thereby effectively reducing the outer diameter of the laser ablation catheter and effectively improving the laser ablation. The pushing performance and passing performance of the ablation catheter can effectively expand the ablation range of the laser ablation catheter and effectively improve the performance of the laser ablation catheter. In addition, the production cost of theablation structure 20 can be effectively reduced, thereby effectively reducing the production cost of the laser ablation catheter.

基于此，通过将消融结构20设置于内管12和外管11之间，以通过管体结构10对消融结构20进行支撑和保护，有效地提升激光消融导管的柔韧性，有效地降低消融结构20容易折断的风险，进而进一步提高激光消融导管的推送性能和通过性能，进一步扩大激光消融导管的消融范围，进一步提高激光消融导管的使用性能。Based on this, by arranging theablation structure 20 between theinner tube 12 and theouter tube 11, theablation structure 20 is supported and protected by thetube structure 10, the flexibility of the laser ablation catheter is effectively improved, and the ablation structure is effectively reduced. 20 risk of easy breakage, further improving the pushing performance and passing performance of the laser ablation catheter, further expanding the ablation range of the laser ablation catheter, and further improving the performance of the laser ablation catheter.

综上，本申请实施例提供的激光消融导管，通过将消融结构20设置为第一光纤21和连接于第一光纤21远端的第二光纤22，以通过第二光纤22对第一光纤21的出射光进行扩束，如此，在达到同样消融效果的条件下，可有效地减少第一光纤21的使用数量，也即可有效地减少消融结构20的使用数量，从而可有效地减少激光消融导管的外径尺寸，有效地提高激光消融导管的推送性能和通过性能，同时，通过将消融结构20设置于内管12和外管11之间，以通过管体结构10对消融结构20进行支撑和保护，有效地提升激光消融导管的柔韧性，有效地降低消融结构20容易折断的风险。因此，在保障激光消融导管柔韧性的同时，还有效地减少激光消融导管的外径尺寸，有效地提高激光消融导管的推送性能和通过性能，有效地扩大激光消融导管的消融范围，有效地提高激光消融导管的使用性能。To sum up, in the laser ablation catheter provided by the embodiment of the present application, by setting theablation structure 20 as the firstoptical fiber 21 and the secondoptical fiber 22 connected to the distal end of the firstoptical fiber 21, the firstoptical fiber 21 is connected to the firstoptical fiber 21 through the secondoptical fiber 22. In this way, under the condition of achieving the same ablation effect, the number of firstoptical fibers 21 used can be effectively reduced, that is, the number of usedablation structures 20 can be effectively reduced, thereby effectively reducing the number of laser ablation The outer diameter of the catheter can effectively improve the pushing performance and passing performance of the laser ablation catheter. At the same time, theablation structure 20 is supported by thetube structure 10 by placing theablation structure 20 between theinner tube 12 and theouter tube 11 and protection, effectively improve the flexibility of the laser ablation catheter, and effectively reduce the risk of theablation structure 20 being easily broken. Therefore, while ensuring the flexibility of the laser ablation catheter, the outer diameter of the laser ablation catheter can be effectively reduced, the pushing performance and passing performance of the laser ablation catheter can be effectively improved, the ablation range of the laser ablation catheter can be effectively expanded, and the Performance of laser ablation catheters.

具体地，请参阅图1、图2，消融结构20设有多个，各消融结构20的第二光纤22呈圆周阵列排布。其中，各消融结构20的第二光纤22绕管体结构10的中心线L1呈圆周阵列排布。Specifically, referring to FIG. 1 and FIG. 2 , there aremultiple ablation structures 20 , and the secondoptical fibers 22 of eachablation structure 20 are arranged in a circular array. Wherein, the secondoptical fibers 22 of eachablation structure 20 are arranged in a circular array around the central line L1 of thetubular structure 10 .

通过采用上述方案，通过绕管体结构10的中心线L1圆周阵列排布多个消融结构20的第二光纤22，如此，可充分利用外管11和内管12之间的安装空间，并可在不增加激光消融导管的外径尺寸条件下，实现布置多个消融结构20的目的，也即，可在不影响激光消融导管通过性能的基础上实现布置多个消融结构20的目的，进而可通过多个消融结构20共同对病变组织进行消融，可有效地增加消融面积，从而有效地提高消融效率；还使得各第二光纤22的出射光斑分布相对均匀，从而利于保障各消融结构20的出射光斑能够紧密相连，有效地减少出射光斑之间的空隙，进而有效地降低消融期间易出现局部病变组织未被消融的情况，有效地提高消融效果和消融效率，有效地保障并提高激光消融导管的使用性能。By adopting the above scheme, the secondoptical fibers 22 of the plurality ofablation structures 20 are arranged in a circular array around the center line L1 of thetube body structure 10, so that the installation space between theouter tube 11 and theinner tube 12 can be fully utilized, and the Without increasing the outer diameter of the laser ablation catheter, the purpose of arrangingmultiple ablation structures 20 can be achieved, that is, the purpose of arrangingmultiple ablation structures 20 can be achieved without affecting the passage performance of the laser ablation catheter, and then can be achieved. The joint ablation of diseased tissue by a plurality ofablation structures 20 can effectively increase the ablation area, thereby effectively improving the ablation efficiency; and also makes the distribution of the exit spots of each secondoptical fiber 22 relatively uniform, thereby helping to ensure the exit of eachablation structure 20 The light spots can be closely connected to effectively reduce the gap between the outgoing light spots, thereby effectively reducing the situation that local lesion tissue is not ablated during the ablation period, effectively improving the ablation effect and ablation efficiency, and effectively ensuring and improving the safety of the laser ablation catheter. Use performance.

具体地，在其中一种可能的实施方式中，相邻两消融结构20的第二光纤22相连接。基于此，通过使得相邻两消融结构20的第二光纤22相连接，即可实现消融结构20的固定以及各消融结构20的第二光纤22的圆周阵列排布，有效地简化激光消融导管的结构，有效地降低激光消融导管的设计和生产成本。Specifically, in one possible implementation manner, the secondoptical fibers 22 of twoadjacent ablation structures 20 are connected. Based on this, by connecting the secondoptical fibers 22 of twoadjacent ablation structures 20, the fixation of theablation structures 20 and the circumferential array arrangement of the secondoptical fibers 22 of eachablation structure 20 can be realized, effectively simplifying the laser ablation catheter. The structure can effectively reduce the design and production cost of the laser ablation catheter.

在另外一种可能的实施方式中，激光消融导管还包括套设于内管12和外管11之间的隔档结构，隔档结构设有呈圆周阵列排布的固定孔，消融结构20的第二光纤22一一对应固定连接于固定孔中。基于此，通过设置套设于内管12和外管11之间的隔档结构，并将消融结构20的第二光纤22一一对应固定连接于固定孔，即可实现各消融结构20的第二光纤22的圆周阵列排布，同时，还利于使相邻两第二光纤22以预设间距间隔设置，以在能够达到同样消融面积和消融效果的条件下，有效地减少第二光纤22的布置数量，也即有效地减少消融结构20的布置数量，进而可有效地降低激光消融导管的生产成本。此外，还利于使得各消融结构20的第一光纤21之间具有较大的间隙，以便于在不增加激光消融导管的外径尺寸的基础上，在第一光纤21的间隙之间布置其他功能部件，也即，以便于在不影响激光消融导管通过性能的基础上实现布置其他功能部件的目的，进而利于实现激光消融导管的各功能部件高度集成化设计的目的，有效地保障并提高激光消融导管的通过性能和使用性能。此外，还可通过隔档结构对外管11和内管12之间远端的缝隙进行有效、可靠地密封，从而有效地降低血液进入外管11和内管12之间的风险，有效地保障激光消融导管的使用性能。本实施例对此不做限制。In another possible implementation, the laser ablation catheter further includes a spacer structure sleeved between theinner tube 12 and theouter tube 11, the spacer structure is provided with fixing holes arranged in a circular array, and theablation structure 20 The secondoptical fibers 22 are fixedly connected in the fixing holes one by one. Based on this, by setting a spacer structure sleeved between theinner tube 12 and theouter tube 11, and fixing and connecting the secondoptical fibers 22 of theablation structures 20 to the fixing holes one by one, the first position of eachablation structure 20 can be realized. The twooptical fibers 22 are arranged in a circular array, and at the same time, it is also beneficial to arrange two adjacent secondoptical fibers 22 at preset intervals, so as to effectively reduce the ablation area and ablation effect of the secondoptical fibers 22. The arrangement quantity, that is, the arrangement quantity of theablation structure 20 can be effectively reduced, thereby effectively reducing the production cost of the laser ablation catheter. In addition, it is also beneficial to have a larger gap between the firstoptical fibers 21 of eachablation structure 20, so that other functions can be arranged between the gaps of the firstoptical fibers 21 without increasing the outer diameter of the laser ablation catheter. Components, that is, in order to achieve the purpose of arranging other functional components on the basis of not affecting the passing performance of the laser ablation catheter, and then facilitate the realization of the purpose of highly integrated design of various functional components of the laser ablation catheter, effectively guarantee and improve laser ablation Catheter through performance and performance. In addition, the gap between theouter tube 11 and theinner tube 12 can be effectively and reliably sealed through the partition structure, thereby effectively reducing the risk of blood entering between theouter tube 11 and theinner tube 12, and effectively protecting the laser beam. Performance of ablation catheters. This embodiment does not limit this.

请参阅图5，在本实施例中，第一光纤21和第二光纤22之间设有过渡光纤段23，过渡光纤段23的径向尺寸在靠近第二光纤22的方向上渐扩设置。优选地，过渡光纤段23呈类圆锥体。Referring to FIG. 5 , in this embodiment, atransition fiber segment 23 is provided between thefirst fiber 21 and thesecond fiber 22 , and the radial dimension of thetransition fiber segment 23 gradually expands toward thesecond fiber 22 . Preferably, thetransition fiber segment 23 is in the shape of a cone.

通过采用上述方案，一方面，利于实现第一光纤21的的出射光基本无损失地传输至第二光纤22中，有效地提高第一光纤21和第二光纤22的耦合效率，有效地降低光能损失的风险，从而利于保障第二光纤22的出射光的能量密度能够满足消融使用需求，有效地保障激光消融导管的使用性能；另一方面，还可实现第一光纤21和第二光纤22平滑过渡连接，从而可有效地降低第一光纤21和第二光纤22连接处的应力，有效地保障第一光纤21和第二光纤22连接处的结构强度，进而有效地保障消融结构20整体的结构强度，有效地保障激光消融导管的使用性能。By adopting the above-mentioned scheme, on the one hand, it is beneficial to realize that the outgoing light of the firstoptical fiber 21 is transmitted to the secondoptical fiber 22 substantially without loss, effectively improving the coupling efficiency of the firstoptical fiber 21 and the secondoptical fiber 22, and effectively reducing the energy loss risk, thereby helping to ensure that the energy density of the outgoing light of the secondoptical fiber 22 can meet the needs of ablation, and effectively ensure the performance of the laser ablation catheter; on the other hand, it can also realize the Smooth transition connection, so as to effectively reduce the stress at the junction of the firstoptical fiber 21 and the secondoptical fiber 22, effectively ensure the structural strength of the junction of the firstoptical fiber 21 and the secondoptical fiber 22, and then effectively ensure the integrity of theablation structure 20 as a whole The structural strength effectively guarantees the performance of the laser ablation catheter.

具体地，过渡光纤段23可以是第一光纤21延伸形成，也可以是第二光纤22延伸形成的，也可以是第一光纤21延伸部分且第二光纤22延伸部分形成的。本实施例对此不做限制。Specifically, thetransition fiber segment 23 may be formed by extending the firstoptical fiber 21 , may also be formed by extending the secondoptical fiber 22 , or may be formed by extending the firstoptical fiber 21 and the secondoptical fiber 22 . This embodiment does not limit this.

具体地，在其中一种可能的实施方式中，可通过电极放电融化第一光纤21和第二光纤22的连接处，以形成具有锥度渐变的熔接连接处，也即以形成具有锥度渐变的过渡光纤段23；在另外一种可能的实施方式中，也可通过将一根粗光纤通过锥度拉丝形成具有锥度渐变的光纤，也即也可以通过将一根粗光纤直接通过锥度拉丝完成消融结构20的生产，此时，消融结构20包括第一光纤21、第二光纤22，以及具有锥度渐变的过渡光纤段23。本实施例对此不做限制。Specifically, in one of the possible implementation manners, the junction of the firstoptical fiber 21 and the secondoptical fiber 22 can be melted by electrode discharge to form a fusion splice with a gradual taper, that is, to form a transition with a tapered gradientOptical fiber segment 23; in another possible implementation manner, it is also possible to form an optical fiber with a tapered gradient by drawing a thick optical fiber through a taper, that is, it is also possible to complete theablation structure 20 by directly drawing a thick optical fiber through a taper production, at this time, theablation structure 20 includes a firstoptical fiber 21, a secondoptical fiber 22, and a transitionaloptical fiber segment 23 with a tapered gradient. This embodiment does not limit this.

当然，在其他可能的实施方式中，请参阅图2，第一光纤21和第二光纤22也可以通过焊接的方式进行拼接实现连接，此时，第一光纤21和第二光纤22之间不具有过渡光纤段23，基于此，可有效地降低消融结构20的设计、生产难度。优选地，第一光纤21和第二光纤22连接端面的中心重合设置，如此，利于使得第二光纤22的出射光斑分布相对均匀，从而利于保障各消融结构20的出射光斑能够紧密相连，有效地减少出射光斑之间的空隙，进而有效地降低消融期间易出现局部病变组织未被消融的情况，有效地提高消融效果和消融效率，有效地保障并提高激光消融导管的使用性能。本实施方式对此不做限制。Of course, in other possible implementation manners, referring to FIG. 2, the firstoptical fiber 21 and the secondoptical fiber 22 can also be spliced by welding to realize the connection. At this time, there is no connection between the firstoptical fiber 21 and the secondoptical fiber 22. There is atransition fiber segment 23, based on which, the design and production difficulty of theablation structure 20 can be effectively reduced. Preferably, the centers of the connecting end faces of the firstoptical fiber 21 and the secondoptical fiber 22 are arranged coincidently, so that the distribution of the exit light spots of the secondoptical fiber 22 is relatively uniform, thereby helping to ensure that the exit light spots of eachablation structure 20 can be closely connected, effectively The gap between the exit spots is reduced, thereby effectively reducing the situation that the local diseased tissue is not ablated during the ablation period, effectively improving the ablation effect and ablation efficiency, and effectively ensuring and improving the performance of the laser ablation catheter. This embodiment does not limit this.

请参阅图2、图3，在本实施例中，激光消融导管还包括设于内管12和外管11之间的调整结构50，调整结构50能够带动管体结构10的远端和消融结构20的远端弯曲。Please refer to Fig. 2 and Fig. 3. In this embodiment, the laser ablation catheter also includes anadjustment structure 50 arranged between theinner tube 12 and theouter tube 11. Theadjustment structure 50 can drive the distal end of thetube structure 10 and the ablation structure. The distal end of 20 is curved.

通过采用上述方案，通过设置调整结构50，以通过调整结构50带动管体结构10的远端和消融结构20的远端弯曲，而实时根据血管的弯曲变化调整激光消融导管的移动方向及朝向，可有效地提高激光消融导管的通过性，还利于调整激光消融导管的远端端口对准待消融的病变组织，而对病变组织进行精准消融，有效地提高激光消融导管的消融准确度，有效地保障并提高激光消融导管的使用性能。By adopting the above solution, by setting theadjustment structure 50, theadjustment structure 50 drives the distal end of thetube body structure 10 and the distal end of theablation structure 20 to bend, and adjusts the moving direction and orientation of the laser ablation catheter in real time according to the bending change of the blood vessel, It can effectively improve the passability of the laser ablation catheter, and is also beneficial to adjust the distal port of the laser ablation catheter to align with the diseased tissue to be ablated, so as to perform precise ablation of the diseased tissue, effectively improve the ablation accuracy of the laser ablation catheter, and effectively Guarantee and improve the performance of laser ablation catheter.

此外，通过将调整结构50设置于内管12和外管11之间，如此，可充分利用内管12和外管11直径的安装空间，可在不增加导管的外径尺寸的情况下，即可实现调整结构50的布置，也即在保障激光消融导管通过性能的同时，还可实现调整结构50的加载，有效地保障并提高激光消融导管的使用性能。In addition, by arranging theadjustment structure 50 between theinner tube 12 and theouter tube 11, the installation space of the diameters of theinner tube 12 and theouter tube 11 can be fully utilized, without increasing the outer diameter of the catheter, that is, The arrangement of theadjustment structure 50 can be realized, that is, while ensuring the passing performance of the laser ablation catheter, the loading of theadjustment structure 50 can also be realized, so as to effectively guarantee and improve the use performance of the laser ablation catheter.

其中，调整结构50可根据需求相对于管体结构10的中心线L1对称设置。本实施例对此不做限制。Wherein, theadjustment structure 50 can be arranged symmetrically with respect to the center line L1 of thepipe structure 10 according to requirements. This embodiment does not limit this.

具体地，调整结构50呈柱状，调整结构50的外径尺寸不超过150μm。如此，在保障调整结构50使用性能的同时，还使得调整结构50的外径尺寸较适。Specifically, theadjustment structure 50 is columnar, and the outer diameter of theadjustment structure 50 does not exceed 150 μm. In this way, while ensuring the performance of theadjustment structure 50 , it also makes the outer diameter of theadjustment structure 50 more appropriate.

具体地，调整结构50采用无生物毒性的金属材质制成，比如食品级不锈钢材质。如此，在保障调整结构50使用性能的同时，还可保障调整结构50的使用安全性。Specifically, theadjustment structure 50 is made of non-biotoxic metal material, such as food-grade stainless steel. In this way, while ensuring the use performance of theadjustment structure 50 , the use safety of theadjustment structure 50 can also be guaranteed.

具体地，在激光消融导管设有隔档结构时，调整结构50可连接于隔档结构的近端端面，也可以不凸出于隔档结构。本实施例对此不做限制。Specifically, when the laser ablation catheter is provided with a spacer structure, theadjustment structure 50 may be connected to the proximal end surface of the spacer structure, or may not protrude from the spacer structure. This embodiment does not limit this.

请参阅图2，在本实施例中，激光消融导管还包括第一成像组件30和引导结构40，第一成像组件30用于实时成像，引导结构40用于导引管体结构10和消融结构20的移动路径；第一成像组件30和引导结构40同时穿设于内管12中，第一成像组件30相对于内管12相对固定，第一成像组件30不凸出于第一光纤21的远端端面。此时，第一成像组件30能够从激光消融导管的侧向进行成像。Please refer to FIG. 2. In this embodiment, the laser ablation catheter further includes afirst imaging component 30 and a guidingstructure 40. Thefirst imaging component 30 is used for real-time imaging, and the guidingstructure 40 is used to guide thetubular structure 10 and the ablation structure. 20; thefirst imaging component 30 and the guidingstructure 40 are simultaneously penetrated in theinner tube 12, thefirst imaging component 30 is relatively fixed relative to theinner tube 12, and thefirst imaging component 30 does not protrude from the side of the firstoptical fiber 21 distal end face. At this time, thefirst imaging component 30 can perform imaging from the side of the laser ablation catheter.

通过采用上述方案，在通过激光消融导管对血管内的病变组织进行消融手术时，先使引导结构40穿梭于内管12中，以导引管体结构10和消融结构20的移动路径，以使管体结构10和消融结构20顺畅地移动至病变组织位置；随后，通过消融结构20对病变组织进行消融，与此同时，通过旋转管体结构10以联动第一成像组件30绕管体结构10的中心线L1进行转动，以使第一成像组件30对激光消融导管的外部进行周向探测，进而可对血管内情况和消融情况进行实时、全方位地成像，并可实时根据成像图像判断消融结构20是否作用到血管壁上，若消融结构20没有作用到血管壁上，则继续进行消融，若消融结构20作用到血管壁上，则停止消融，并可及时调整激光消融导管远端的位置，直至消融结构20不会作用到血管壁上再继续进行消融。By adopting the above scheme, when the laser ablation catheter is used to ablate the diseased tissue in the blood vessel, firstly, the guide structure 40 is shuttled in the inner tube 12 to guide the movement path of the tube structure 10 and the ablation structure 20, so that The tubular structure 10 and the ablation structure 20 smoothly move to the position of the diseased tissue; then, the ablation structure 20 is used to ablate the diseased tissue, and at the same time, the first imaging component 30 is rotated around the tubular structure 10 by rotating the tubular structure Rotate the center line L1 of the laser ablation catheter, so that the first imaging component 30 can detect the outside of the laser ablation catheter in a circumferential direction, and then can perform real-time and all-round imaging of the intravascular situation and ablation situation, and can judge the ablation according to the imaging image in real time Whether the structure 20 acts on the blood vessel wall, if the ablation structure 20 does not act on the blood vessel wall, continue ablation, if the ablation structure 20 acts on the blood vessel wall, stop the ablation, and adjust the position of the distal end of the laser ablation catheter in time , the ablation is continued until the ablation structure 20 does not act on the blood vessel wall.

因此，通过使第一成像组件30和引导结构40同时穿设于内管12中，一方面，通过引导结构40对管体结构10和消融结构20的移动路径进行引导，以使管体结构10和消融结构20顺畅地移动至或通过病变组织，有效地提高消融手术效率，另一方面，通过第一成像组件30在消融期间对血管内情况和消融情况进行实时成像，可实时根据成像图像判断消融结构20是否作用到血管壁上，可有效地降低消融结构20作用到血管壁上而对血管壁造成损伤的风险，有效地提高消融期间的安全性，还可实时根据成像图像判断病变组织是否存在部分遗漏而未被消融的情况，进而可及时调整激光消融导管的远端端口的位置，以及时对病变组织存在遗漏的部分进行有效、可靠地消融，有效地保障激光消融导管的消融效果和消融准确度，有效地保障并提高激光消融导管的使用性能；另一方面，可在不增加激光消融导管的外径尺寸的基础上，以充分利用内管12中的内部空间进行引导结构40和第一成像组件30的布置，也即在保障激光消融导管的推送性能和通过性能的同时，还可实现引导结构40和第一成像组件30的搭载，有效地提高激光消融导管的使用性能。Therefore, by passing the first imaging component 30 and the guide structure 40 through the inner tube 12 at the same time, on the one hand, the guide structure 40 guides the moving paths of the tube structure 10 and the ablation structure 20, so that the tube structure 10 and the ablation structure 20 smoothly move to or through the diseased tissue, effectively improving the efficiency of the ablation operation; Whether the ablation structure 20 acts on the blood vessel wall can effectively reduce the risk of damage to the blood vessel wall caused by the ablation structure 20 acting on the blood vessel wall, effectively improve the safety during ablation, and judge whether the diseased tissue is real-time based on the imaging image In the case of partial omission but not ablation, the position of the distal port of the laser ablation catheter can be adjusted in time to effectively and reliably ablate the part of the diseased tissue that is missed, effectively ensuring the ablation effect of the laser ablation catheter and The ablation accuracy can effectively guarantee and improve the performance of the laser ablation catheter; on the other hand, on the basis of not increasing the outer diameter of the laser ablation catheter, the internal space in the inner tube 12 can be fully utilized to guide the structure 40 and The arrangement of the first imaging component 30, that is, while ensuring the pushing and passing performance of the laser ablation catheter, can also realize the loading of the guide structure 40 and the first imaging component 30, effectively improving the performance of the laser ablation catheter.

当然，也可以直接通过医护人员手动控制管体结构10和消融结构20的移动路径，以使管体结构10和消融结构20移动至病变组织位置。本实施例对此不做限制。Certainly, the moving paths of thetubular structure 10 and theablation structure 20 can also be directly manually controlled by the medical staff, so that thetubular structure 10 and theablation structure 20 can be moved to the position of the diseased tissue. This embodiment does not limit this.

基于此，通过设置第一成像组件30相对于内管12相对固定，使得第一成像组件30固定于内管12中，此时，引导结构40能够穿梭于第一成像组件30和内管12内壁之间的缝隙，第一成像组件30的探测光线能够通过第一光纤21之间的缝隙进行出射。如此，一方面，虽然牺牲一定的成像质量，但是由于第一光纤21的外径尺寸往往较小，第一成像组件30的探测光线的大部分能够通过第一光纤21之间的缝隙出射，此时，通过第一成像组件30的成像效果仍然足够满足判断消融情况的需求，同时，可以不增加激光消融导管的外径尺寸，也即在保障激光消融导管的推送性能和通过性能的同时，可以实现第一成像组件30的加载，有效地保障并提高激光消融导管的使用性能；另一方面，不需要将第一成像组件30从内管12中抽出，即可能够将引导结构40穿梭于内管12中而实现引导结构40的导引作用，有效地节省引导结构40和第一成像组件30交替的操作时间，从而可有效地提高消融手术效率；另一方面，通过内管12对第一成像组件30进行收纳和保护，还可有效地降低第一成像组件30被污染、第一成像组件30丢失的风险。Based on this, by setting thefirst imaging assembly 30 relatively fixed relative to theinner tube 12, so that thefirst imaging assembly 30 is fixed in theinner tube 12, at this time, theguide structure 40 can shuttle between thefirst imaging assembly 30 and the inner wall of theinner tube 12 The detection light of thefirst imaging component 30 can exit through the gap between the firstoptical fibers 21 . In this way, on the one hand, although a certain imaging quality is sacrificed, since the outer diameter of the firstoptical fiber 21 is often small, most of the detection light of thefirst imaging component 30 can exit through the gap between the firstoptical fibers 21. , the imaging effect through thefirst imaging component 30 is still sufficient to meet the needs of judging the ablation situation. Realize the loading of thefirst imaging assembly 30, effectively guarantee and improve the use performance of the laser ablation catheter; The guiding function of the guidingstructure 40 is realized in thetube 12, effectively saving the operating time of the guidingstructure 40 and thefirst imaging assembly 30 alternately, thereby effectively improving the efficiency of the ablation operation; on the other hand, through theinner tube 12 to the first The storage and protection of theimaging assembly 30 can also effectively reduce the risk of contamination of thefirst imaging assembly 30 and loss of thefirst imaging assembly 30 .

基于此，通过设置第一成像组件30不凸出于第一光纤21的远端端面，可有效地降低第二光纤22对第一成像组件30的探射光线遮挡过多而影响成像效果的风险，有效地保障第一成像组件30的成像效果，有效地保障第一成像组件30的使用性能。Based on this, by setting thefirst imaging component 30 not protruding from the distal end face of the firstoptical fiber 21, the risk that the secondoptical fiber 22 blocks the probe light of thefirst imaging component 30 too much and affects the imaging effect can be effectively reduced. , effectively guarantee the imaging effect of thefirst imaging component 30 , and effectively guarantee the performance of thefirst imaging component 30 .

具体地，第一成像组件30为OCT(Optical Coherence Tomography，光学相干断层成像)成像组件。如此，可通过利用宽带光源的低相干干涉技术获取高分辨率的层析成像，有利于医护人员对血管内病变组织的类型和程度进行更准确的评估，有效地保障并提高第一成像组件30使用性能。Specifically, thefirst imaging component 30 is an OCT (Optical Coherence Tomography, optical coherence tomography) imaging component. In this way, high-resolution tomographic imaging can be obtained by using the low-coherence interference technology of broadband light sources, which is beneficial for medical staff to more accurately evaluate the type and degree of intravascular diseased tissue, and effectively guarantees and improves thefirst imaging component 30. Use performance.

具体地，内管12和外管11均采用具有透光性能的材质制成，比如，FEP(Fluorinated ethylene propylene，聚全氟乙丙烯共聚物)、PTFE(Teflon，聚四氟乙烯)、PC(Polycarbonate，聚碳酸酯)等材质，基于此，基于FEP材质、PTFE材质、PC材质等材质具有良好通光性能、生物组织亲和性、对人体无毒害作用、化学性质稳定等特性，一方面，使得内管12和外管11均具有较优的透光性能，从而保障第一成像组件30的探测光线能够顺利的穿过内管12和外管11而朝管体结构10外出射，有效地保障成像效果；另一方面，还有效地保障内管12和外管11的使用安全性，有效地保障管体结构10的使用性能。优选地，内管12采用PTFE材质，基于PTFE材质的摩擦系数极低，便于顺畅地使引导结构40相对于内管12移动，进一步提高激光消融导管的通过性能和使用性能。Specifically, both theinner tube 12 and theouter tube 11 are made of materials with light transmission properties, such as FEP (Fluorinated ethylene propylene, polyperfluoroethylene propylene copolymer), PTFE (Teflon, polytetrafluoroethylene), PC ( Polycarbonate, polycarbonate) and other materials, based on this, based on FEP materials, PTFE materials, PC materials and other materials have good light transmission performance, biological tissue affinity, non-toxic effects on the human body, and stable chemical properties. On the one hand, Both theinner tube 12 and theouter tube 11 have better light transmission performance, thereby ensuring that the detection light of thefirst imaging component 30 can pass through theinner tube 12 and theouter tube 11 smoothly and exit thetube body structure 10, effectively The imaging effect is guaranteed; on the other hand, the use safety of theinner tube 12 and theouter tube 11 is effectively guaranteed, and the performance of thetube body structure 10 is effectively guaranteed. Preferably, theinner tube 12 is made of PTFE material, which has an extremely low coefficient of friction, which facilitates the smooth movement of the guidingstructure 40 relative to theinner tube 12, and further improves the passing performance and usability of the laser ablation catheter.

具体地，外管11的厚度小于200μm。基于此，可使外管11具有较高的光透过率，进而保障第一成像组件30的成像效果，还可在保障外管11的使用性能的同时，使得外管11的厚度较适，进一步减少激光消融导管的外径尺寸，进一步保障并提供激光消融导管的通过性能、推送性能和使用性能。Specifically, the thickness of theouter tube 11 is less than 200 μm. Based on this, theouter tube 11 can be made to have a higher light transmittance, thereby ensuring the imaging effect of thefirst imaging component 30, and while ensuring the performance of theouter tube 11, the thickness of theouter tube 11 is more appropriate. The outer diameter of the laser ablation catheter is further reduced, and the passage performance, push performance and use performance of the laser ablation catheter are further guaranteed and provided.

其中，在激光消融导管设置上述调整结构50时，调整结构50不凸出于第一成像组件30的成像探头的近端，如此，可有效地降低调整结构50对第一成像组件30的探测光线的遮挡而影响成像效果的风险；此外，在消融期间，若根据第一成像组件30的成像图像判断消融结构20作用到血管壁上时，可及时通过调整结构50调整激光消融导管远端的位置，直至消融结构20不会作用到血管壁上再继续进行消融，有效地提高消融期间的安全性；还可根据第一成像组件30的成像图像判断病变区域的消融效果，从而可及时地通过调节结构控制激光消融导管的移动以到达未被消融的病变组织区域再继续进行消融。Wherein, when the laser ablation catheter is provided with theadjustment structure 50, theadjustment structure 50 does not protrude from the proximal end of the imaging probe of thefirst imaging assembly 30, so that the detection light of theadjustment structure 50 to thefirst imaging assembly 30 can be effectively reduced. In addition, during ablation, if theablation structure 20 acts on the vessel wall according to the imaging image of thefirst imaging component 30, the position of the distal end of the laser ablation catheter can be adjusted in time by adjusting thestructure 50 , continue the ablation until theablation structure 20 does not act on the blood vessel wall, effectively improving the safety during the ablation period; the ablation effect of the lesion area can also be judged according to the imaging image of thefirst imaging component 30, so that the ablation effect can be adjusted in time The structure controls the movement of the laser ablation catheter to reach the non-ablated diseased tissue area and continue the ablation.

请参阅图2，在本实施例中，第一成像组件30和引导结构40同时穿设于内管12中，内管12的内部分隔形成第一管腔121和第二管腔122，第一成像组件30穿设于第一管腔121中，引导结构40穿梭于第二管腔122中。Please refer to FIG. 2 , in this embodiment, thefirst imaging component 30 and the guidingstructure 40 are simultaneously passed through theinner tube 12, and theinner tube 12 is divided to form afirst lumen 121 and asecond lumen 122. The first Theimaging component 30 passes through thefirst lumen 121 , and the guidingstructure 40 shuttles through thesecond lumen 122 .

通过采用上述方案，通过将内管12的内部分隔形成第一管腔121和第二管腔122，以使得第一成像组件30穿设于第一管腔121中，引导结构40穿梭于第二管腔122中，可实现对第一成像组件30和引导组件的有效、可靠地分割，可有效地降低在引导结构40穿梭于内管12中与第一成像组件30发生相互干涉、碰撞的风险，有效地保障第一成像组件30和引导结构40的使用性能，有效地保障激光消融导管的使用性能。By adopting the above solution, thefirst lumen 121 and thesecond lumen 122 are formed by dividing the interior of theinner tube 12, so that thefirst imaging component 30 is passed through thefirst lumen 121, and theguide structure 40 is shuttled through the second lumen. In thelumen 122, thefirst imaging component 30 and the guide component can be effectively and reliably divided, and the risk of mutual interference and collision with thefirst imaging component 30 when theguide structure 40 shuttles through theinner tube 12 can be effectively reduced. , to effectively ensure the usability of thefirst imaging component 30 and theguide structure 40, and effectively guarantee the usability of the laser ablation catheter.

请参阅图2，在本实施例中，第一管腔121的中心线L2偏离管体结构10的中心线L1设置。Referring to FIG. 2 , in this embodiment, the centerline L2 of thefirst lumen 121 is set away from the centerline L1 of thetubular structure 10 .

通过采用上述方案，通过设置第一管腔121的中心线L2偏离管体结构10的中心线L1设置，使得第一成像组件30偏离管体结构10的中心线L1而呈偏心设置，与此同时，引导结构40靠近管体结构10的中心线L1进行引导，如此，可以实现中间引导，侧边成像的设置，从而在保障引导结构40引导管体结构10和消融结构20在血管内平稳、可靠地前进的同时，还可有效地降低引导结构40对第一成像组件30的探测光线遮挡的风险，有效地保障第一成像组件30的成像效果，By adopting the above solution, by setting the centerline L2 of thefirst lumen 121 away from the centerline L1 of thetubular structure 10, thefirst imaging assembly 30 is arranged eccentrically away from the centerline L1 of thetubular structure 10, and at the same time , the guidingstructure 40 is guided close to the centerline L1 of thetubular structure 10, so that middle guiding and side imaging settings can be realized, so as to ensure that the guidingstructure 40 guides thetubular structure 10 and theablation structure 20 in the blood vessel stably and reliably While advancing smoothly, the risk of theguide structure 40 blocking the detection light of thefirst imaging component 30 can be effectively reduced, and the imaging effect of thefirst imaging component 30 can be effectively guaranteed.

请参阅图2，在本实施例中，内管12的外径在靠近远端的方向渐缩设置。Please refer to FIG. 2 , in this embodiment, the outer diameter of theinner tube 12 is tapered toward the distal end.

通过采用上述方案，通过设置内管12的外径在靠近远端的方向渐缩设置，使得内管12远端的外径尺寸较小，进而使得整个管体结构10远端的外径尺寸较小，进而进一步减少激光消融导管远端的外径尺寸，进一步提高激光消融导管的推送性能和通过性能。By adopting the above scheme, by setting the outer diameter of theinner tube 12 to be tapered in the direction close to the distal end, the outer diameter of the distal end of theinner tube 12 is smaller, and the outer diameter of the distal end of the entiretubular structure 10 is smaller. Small, further reducing the outer diameter of the distal end of the laser ablation catheter, and further improving the pushing performance and passing performance of the laser ablation catheter.

请参阅图2，在本实施例中，第一管腔121不凸出于第一光纤21的远端端面。Please refer to FIG. 2 , in this embodiment, thefirst lumen 121 does not protrude from the distal end surface of the firstoptical fiber 21 .

通过采用上述方案，一方面，可有效地保障第一成像组件30不凸出于第一光纤21的远端端面，以降低第二光纤22对第一成像组件30的探测光线过多遮挡而影响成像效果的风险，有效地保障第一成像组件30的使用性能；另一方面，通过取消凸出于第一光纤21的远端端面部分对应的第一管腔121，利于实现凸出于第一管腔121的内管12部分的外径尺寸小于与第一管腔121相对的内管12部分的外径尺寸，也即可利于实现内管12的外径在靠近远端的方向渐缩设5置的目的。By adopting the above scheme, on the one hand, it can effectively ensure that thefirst imaging component 30 does not protrude from the distal end face of the firstoptical fiber 21, so as to reduce the influence of the secondoptical fiber 22 on the detection light of thefirst imaging component 30 due to excessive occlusion. The risk of the imaging effect can effectively guarantee the performance of thefirst imaging component 30; The outer diameter of the part of theinner tube 12 of thelumen 121 is smaller than the outer diameter of the part of theinner tube 12 opposite to thefirst lumen 121, that is, it can facilitate the realization of the tapering design of the outer diameter of theinner tube 12 in the direction close to the distal end. 5 set the purpose.

请参阅图3，在本实施例中，激光消融导管还包括设于外管11和内管12之间的至少一个第二成像组件60，第二成像组件60不凸出于第一光纤21的远端端面，用于实时成像。其中，第二成像组件60和第一成像组件30的类型不Please refer to FIG. 3 , in this embodiment, the laser ablation catheter further includes at least onesecond imaging component 60 disposed between theouter tube 11 and theinner tube 12 , thesecond imaging component 60 does not protrude from the firstoptical fiber 21 Distal facet for live imaging. Wherein, the types of thesecond imaging assembly 60 and thefirst imaging assembly 30 are different

同。比如，第一成像组件30可以为OCT成像组件，第二成像组件60可以为ivus0(Intravascular ultrasound，血管内超声)成像组件。此时，第二成像组件60能够从激光消融导管的侧向进行成像。same. For example, thefirst imaging component 30 may be an OCT imaging component, and thesecond imaging component 60 may be an ivus0 (Intravascular ultrasound, intravascular ultrasound) imaging component. At this time, thesecond imaging component 60 can perform imaging from the side of the laser ablation catheter.

通过采用上述方案，通过于外管11和内管12之间设置至少一个第二成像组件60，以通过第二成像组件60对血管内情况和消融情况进行实时成像，进By adopting the above solution, by setting at least onesecond imaging component 60 between theouter tube 11 and theinner tube 12, thesecond imaging component 60 can perform real-time imaging of intravascular conditions and ablation conditions, and further

而可实时根据成像图像判断消融结构20是否作用到血管壁上，可有效地降低消5融结构20作用到血管壁上而对血管壁造成损伤的风险，有效地提高消融期间的安全性，有效地保障并提高激光消融导管的使用性能；还可实时根据成像图像判断病变组织是否存在部分遗漏而未被消融的情况，进而可及时调整激光消融导管的远端端口的位置，以及时对病变组织存在遗漏的部分进行有效、可靠地However, it can be judged in real time according to the imaging image whether theablation structure 20 acts on the blood vessel wall, which can effectively reduce the risk of damage to the blood vessel wall caused by theablation structure 20 acting on the blood vessel wall, effectively improve the safety during ablation, and effectively It can ensure and improve the performance of the laser ablation catheter; it can also judge in real time according to the imaging image whether there is a part of the diseased tissue that has not been ablated, and then adjust the position of the distal port of the laser ablation catheter in time to timely treat the diseased tissue. The missing parts are effectively and reliably

消融，有效地保障激光消融导管的消融效果和消融准确度，此外，还可在不增0加激光消融导管的外径尺寸的基础上，以充分利用内管12和外管11之间的安装空间进行第二成像组件60的布置，也即在保障激光消融导管的推送性能和通过性能的同时，还可实现第二成像组件60的搭载，有效地提高激光消融导管的使用性能。ablation, effectively guaranteeing the ablation effect and ablation accuracy of the laser ablation catheter, in addition, on the basis of not increasing the outer diameter of the laser ablation catheter, to make full use of the installation between theinner tube 12 and theouter tube 11 Space for the arrangement of thesecond imaging component 60, that is, while ensuring the pushing performance and passing performance of the laser ablation catheter, it can also realize the loading of thesecond imaging component 60, effectively improving the performance of the laser ablation catheter.

通过设置第二成像组件60不凸出于第一光纤21的远端端面，可有效地降5低第二光纤22对第二成像组件60的探射信号遮挡过多而影响成像效果的风险，By arranging that thesecond imaging component 60 does not protrude from the distal end face of the firstoptical fiber 21, the risk that the secondoptical fiber 22 blocks the probe signal of thesecond imaging component 60 too much and affects the imaging effect can be effectively reduced.

有效地保障第二成像组件60的成像效果，有效地保障第二成像组件60的使用性能。The imaging effect of thesecond imaging component 60 is effectively guaranteed, and the performance of thesecond imaging component 60 is effectively guaranteed.

具体地，请参阅图4，当第二成像组件60设有多个时，多个第二成像组件60呈圆周阵列排布。其中，多个第二成像组件60绕管体结构10的中心线L1呈圆周阵列排布。基于此，通过绕管体结构10的中心线L1呈圆周阵列设置多个第二成像组件60，以通过多个第二成像组件60同时对血管内情况和消融情况进行全方位、较大范围地实时成像，成像效果好，进而便于对消融结构20是否作用到血管壁上进行全面、可靠地分析、判断，进一步降低消融结构20作用到血管壁上而对血管壁造成损伤的风险，进一步提高消融期间的安全性。Specifically, referring to FIG. 4 , when multiplesecond imaging assemblies 60 are provided, the multiplesecond imaging assemblies 60 are arranged in a circular array. Wherein, a plurality ofsecond imaging assemblies 60 are arranged in a circular array around the central line L1 of thetubular structure 10 . Based on this, a plurality ofsecond imaging components 60 are arranged in a circular array around the center line L1 of thetubular structure 10, so that the intravascular conditions and ablation conditions can be comprehensively and relatively large Real-time imaging, with good imaging effect, facilitates comprehensive and reliable analysis and judgment on whether theablation structure 20 acts on the vessel wall, further reduces the risk of damage to the vessel wall caused by theablation structure 20 acting on the vessel wall, and further improves the ablation rate. security during the period.

其中，请参阅图3，在激光消融导管设置上述调整结构50时，调整结构50不凸出于第二成像组件60的成像探头的近端，或，调整结构50设置于第一光纤21朝向内管12的一侧，如此，可有效地降低调整结构50对第二成像组件60的探测信号的遮挡而影响成像效果的风险；此外，还可根据第二成像组件60的成像图像判断病变区域的消融效果，从而可及时地通过调节结构控制激光消融导管的移动以到达未被消融的病变组织区域再继续进行消融，有效地保障激光消融导管的使用性能。Wherein, please refer to FIG. 3 , when the above-mentionedadjustment structure 50 is provided on the laser ablation catheter, theadjustment structure 50 does not protrude from the proximal end of the imaging probe of thesecond imaging assembly 60, or theadjustment structure 50 is arranged on the firstoptical fiber 21 facing inward. One side of thetube 12, in this way, can effectively reduce the risk of affecting the imaging effect due to the blocking of the detection signal of thesecond imaging assembly 60 by theadjustment structure 50; Therefore, the movement of the laser ablation catheter can be controlled in time by adjusting the structure to reach the non-ablated lesion tissue area and then continue to ablate, effectively ensuring the performance of the laser ablation catheter.

请参阅图3、图4，在本实施例中，激光消融导管还包括套设于各第一光纤21外的安装套70，各第二成像组件60分别安装于安装套70的外周。Please refer to FIG. 3 and FIG. 4 , in this embodiment, the laser ablation catheter further includes a mountingsleeve 70 sheathed outside each firstoptical fiber 21 , and eachsecond imaging assembly 60 is mounted on the outer periphery of the mountingsleeve 70 .

通过采用上述方案，通过将各第二成像组件60分别安装于安装套70的外周，即可通过安装套70对第二成像组件60进行支撑，通过将安装套70套设于各第一光纤21外，即可实现安装套70和各第二成像组件60的安装，安装操作十分方便、简单，可有效地提升第二成像组件60的组装良率，同时，还可极大地降低第一光纤21对第二成像组件60的探测信号遮挡而影响成像效果的风险，有效地保障并提高第二成像组件60的成像效果；通过采用安装套70将各第二成像组件60进行一体化集成设计，还利于减少安装套70和第二成像组件60的整体厚度尺寸，进而有效减少第二成像组件60和安装套70的占用空间，更利于在不增加管体结构10外径尺寸的情况下实现第二成像组件60和安装套70的顺利、便捷地安装，也即，进而利于在保障激光消融导管通过性能的情况下，还便于顺利、便捷集成第二成像组件60；此外，还利于实现管体结构10联动安装套70弯曲，有效地缩短激光消融导管远端的不可弯折部分，进而可进一步有效地提高激光消融导管的通过性能和推送性能。By adopting the above scheme, by installing eachsecond imaging assembly 60 on the outer periphery of theinstallation sleeve 70 respectively, thesecond imaging assembly 60 can be supported by theinstallation sleeve 70, and by setting theinstallation sleeve 70 on each firstoptical fiber 21 In addition, the installation of theinstallation sleeve 70 and thesecond imaging components 60 can be realized. The installation operation is very convenient and simple, which can effectively improve the assembly yield of thesecond imaging components 60. At the same time, it can also greatly reduce the cost of the firstoptical fiber 21. The risk of affecting the imaging effect by blocking the detection signal of thesecond imaging assembly 60 can effectively guarantee and improve the imaging effect of thesecond imaging assembly 60; It is beneficial to reduce the overall thickness of theinstallation sleeve 70 and thesecond imaging assembly 60, thereby effectively reducing the occupied space of thesecond imaging assembly 60 and theinstallation sleeve 70, and is more conducive to realizing the second imaging assembly without increasing the outer diameter of thetubular structure 10. The smooth and convenient installation of theimaging component 60 and the mountingsleeve 70, that is, facilitates the smooth and convenient integration of thesecond imaging component 60 while ensuring the passing performance of the laser ablation catheter; in addition, it is also conducive to realizing thetube structure 10 Thelinkage installation sleeve 70 is bent, effectively shortening the non-bendable part of the distal end of the laser ablation catheter, and further effectively improving the passing performance and pushing performance of the laser ablation catheter.

当然，在其他可能的实施方式中，安装套70也可以套设于内管12外，此时，第二成像组件60的探测信号通过第一光纤21之间的缝隙射出。本实施例对此不做限制。Of course, in other possible implementations, the mountingsleeve 70 can also be sleeved outside theinner tube 12 , at this time, the detection signal of thesecond imaging component 60 is emitted through the gap between the firstoptical fibers 21 . This embodiment does not limit this.

当然，在其他可能的实施方式中，第二成像组件60可以直接安装于外管11的内壁，此时，可极大地降低第一光纤21对第二成像组件60的探测信号遮挡而影响成像效果的风险，有效地保障并提高第二成像组件60的成像效果；第二成像组件60也可以设于第一光纤21之间的空隙之中，以充分利用外管11和内管12之间的安装空间，并可有效地降低第一光纤21对第二成像组件60的探测信号遮挡而影响成像效果的风险，第二成像组件60还可以紧贴于第一光纤21的外侧设置。本实施例对此不做限制。Of course, in other possible implementations, thesecond imaging component 60 can be directly installed on the inner wall of theouter tube 11. At this time, the blocking of the detection signal of thesecond imaging component 60 by the firstoptical fiber 21 can be greatly reduced and the imaging effect will be affected. risk, effectively guarantee and improve the imaging effect of thesecond imaging assembly 60; The installation space can effectively reduce the risk of the firstoptical fiber 21 blocking the detection signal of thesecond imaging component 60 and affecting the imaging effect. Thesecond imaging component 60 can also be arranged close to the outside of the firstoptical fiber 21 . This embodiment does not limit this.

具体地，请参阅图4，当第二成像组件60设有多个时，安装套70为多边形管状，各第二成像组件60分别安装在安装套70的各侧面。比如，当第二成像组件60设有6个时，安装套70为六边形管状。如此，通过将安装套70设置为多边形管状，可有效地保障各第二成像组件60的安装面积，还可有效地降低各第二成像组件60发生相互干涉而无法安装的风险，有效地保障Specifically, please refer to FIG. 4 , when there are multiplesecond imaging assemblies 60 , the mountingsleeve 70 is polygonal tubular, and eachsecond imaging assembly 60 is mounted on each side of the mountingsleeve 70 . For example, when there are sixsecond imaging assemblies 60, the mountingsleeve 70 is in the shape of a hexagonal tube. In this way, by setting theinstallation sleeve 70 into a polygonal tubular shape, the installation area of eachsecond imaging assembly 60 can be effectively guaranteed, and the risk that eachsecond imaging assembly 60 will interfere with each other and cannot be installed can be effectively reduced.

具体地，安装套70可以为柔性电路板，也可以为采用其他柔性材料制成地安装套70。本实施例对此不做限制。Specifically, the mountingsleeve 70 may be a flexible circuit board, or may be a mountingsleeve 70 made of other flexible materials. This embodiment does not limit this.

请参阅图3、图4，在本实施例中，第二成像组件60包括连接于安装套70背离内管12一侧的芯片61，以及连接于芯片61背离安装套70一侧且与芯片61电连接的至少一个超声换能器62。Please refer to FIG. 3 and FIG. 4 , in this embodiment, thesecond imaging component 60 includes achip 61 connected to the side of the mountingsleeve 70 away from theinner tube 12 , and connected to the side of thechip 61 away from the mountingsleeve 70 and connected to thechip 61 At least oneultrasonic transducer 62 is electrically connected.

通过采用上述方案，通过将第二成像组件60设置为芯片61，以及与芯片61电连接的超声换能器62，即可通过第二成像组件60运用超声成像观察消融效果，可准确测量血管管腔及病变组织的大小，尤其利于医护人员对复杂病变进行更准确的评估，有效地保障并提高第二成像组件60的使用性能。By adopting the above scheme, by setting thesecond imaging component 60 as achip 61 and theultrasonic transducer 62 electrically connected to thechip 61, the ablation effect can be observed through thesecond imaging component 60 using ultrasonic imaging, and the blood vessels can be accurately measured. The size of the cavity and the lesion tissue is especially beneficial for the medical staff to make a more accurate assessment of the complex lesion, effectively guaranteeing and improving the performance of thesecond imaging component 60 .

请参阅图4，在本实施例中，超声换能器62设有多个，多个超声换能器62相互间隔设置。优选地，多个超声换能器62以预设间距(比如90μm)相互间隔设置。Please refer to FIG. 4 , in this embodiment, there are multipleultrasonic transducers 62 , and the multipleultrasonic transducers 62 are arranged at intervals from each other. Preferably, a plurality ofultrasonic transducers 62 are arranged at a predetermined interval (such as 90 μm) apart from each other.

通过采用上述方案，通过设置多个(比如10个)超声换能器62，以通过多个超声换能器62共同进行探测，利于使得第二成像组件60能够满足较高成像频率(比如20MHz以上)的使用要求，有效地保障并提高第二成像组件60的使用性能。By adopting the above solution, by setting multiple (such as 10)ultrasonic transducers 62, so as to jointly perform detection through multipleultrasonic transducers 62, it is beneficial to enable thesecond imaging component 60 to meet the higher imaging frequency (such as above 20MHz) ) to effectively guarantee and improve the performance of thesecond imaging component 60.

请参阅图3、图4，在本实施例中，超声换能器62为压电微机械超声换能器(Piezoelectric Micromachined Ultrasonic Transducer，PMUT)。Please refer to FIG. 3 and FIG. 4. In this embodiment, theultrasonic transducer 62 is a piezoelectric micromachined ultrasonic transducer (Piezoelectric Micromachined Ultrasonic Transducer, PMUT).

通过采用上述方案，基于压电微机械超声换能器既可以做执行器(发射声波)，又可以做传感器(接收声波)，以及可靠性和一致性较高的特性，在保障超声换能器62使用性能的同时，还有效地降低超声换能器62的生产成本。By adopting the above scheme, based on the piezoelectric micromechanical ultrasonic transducer, it can be used not only as an actuator (emitting sound waves), but also as a sensor (receiving sound waves), and has high reliability and consistency. 62 use performance, but also effectively reduce the production cost of theultrasonic transducer 62.

请参阅图3，在本实施例中，外管11的至少与第二成像组件60相对设置的部分由具有超声耦合特性的材质制成。例如，RTV(room temperature vulcanized siliconerubber，室温硫化硅橡胶)等材料。Please refer to FIG. 3 , in this embodiment, at least the part of theouter tube 11 opposite to thesecond imaging component 60 is made of a material with ultrasonic coupling properties. For example, materials such as RTV (room temperature vulcanized silicon rubber, room temperature vulcanized silicone rubber).

通过采用上述方案，通过设置外管11的至少与第二成像组件60相对设置的部分由具有超声耦合特性的材质制成，可有效地保障第二成像组件60的探测信号顺利地通过外管11朝向管体结构10外部发射，有效地保障第二成像组件60的成像效果，有效地保障第二成像组件60的使用性能。By adopting the above scheme, by setting at least the part of theouter tube 11 opposite to thesecond imaging component 60 to be made of a material with ultrasonic coupling properties, it can effectively ensure that the detection signal of thesecond imaging component 60 passes through theouter tube 11 smoothly. Emitting towards the outside of thetubular structure 10 can effectively guarantee the imaging effect of thesecond imaging component 60 and effectively guarantee the performance of thesecond imaging component 60 .

实施例二Embodiment two

本实施例与实施例一的区别在于：The difference between this embodiment and Embodiment 1 is:

请参阅图7，在本实施例中，第一成像组件30和引导结构40交替穿设于内管12中。此时，内管12具有一个中心管腔，第一成像组件30和引导结构40交替穿设于内管12的中心管腔中。此时，第一成像组件30能够经由内管12的远端管口获取图像、成像，也即第一成像组件30能够从激光消融导管的前向进行成像。Please refer to FIG. 7 , in this embodiment, thefirst imaging component 30 and the guidingstructure 40 are alternately passed through theinner tube 12 . At this time, theinner tube 12 has a central lumen, and thefirst imaging components 30 and the guidingstructures 40 are alternately passed through the central lumen of theinner tube 12 . At this time, thefirst imaging component 30 can acquire images and form images through the distal nozzle of theinner tube 12 , that is, thefirst imaging component 30 can perform imaging from the front of the laser ablation catheter.

通过采用上述方案，在通过激光消融导管对血管内的病变组织进行消融手术时，先使引导结构40穿梭于内管12的中心管腔中，以导引管体结构10和消融结构20的移动路径，以使管体结构10和消融结构20顺畅地移动至病变组织位置；随后，将引导结构40移出内管12的中心管腔，并替换第一成像组件30穿梭于内管12的中心管腔中，同时，通过消融结构20对病变组织进行消融，进而可通过第一成像组件30对血管内情况和消融情况进行实时成像，并实时根据成像图像判断消融结构20是否作用到血管壁上，若消融结构20没有作用到血管壁上，则继续进行消融，若消融结构20作用到血管壁上，则停止消融，并可及时调整激光消融导管远端的位置，直至消融结构20不会作用到血管壁上再继续进行消融。By adopting the above scheme, when the laser ablation catheter is used to ablate the diseased tissue in the blood vessel, theguide structure 40 is first shuttled in the central lumen of theinner tube 12 to guide the movement of thetube structure 10 and theablation structure 20 path, so that thetubular structure 10 and theablation structure 20 can move smoothly to the lesion tissue position; then, the guidingstructure 40 is moved out of the central lumen of theinner tube 12, and thefirst imaging component 30 is replaced by the central tube of theinner tube 12 At the same time, theablation structure 20 is used to ablate the diseased tissue, and then thefirst imaging component 30 can be used to perform real-time imaging of the intravascular situation and ablation situation, and judge whether theablation structure 20 has acted on the blood vessel wall according to the imaging image in real time. If theablation structure 20 does not act on the blood vessel wall, continue the ablation; if theablation structure 20 acts on the blood vessel wall, stop the ablation, and adjust the position of the distal end of the laser ablation catheter in time until theablation structure 20 does not act on the blood vessel wall The ablation is continued on the vessel wall.

因此，通过使引导结构40和第一成像组件30交替地穿梭于内管12中，一方面，通过引导结构40对管体结构10和消融结构20的移动路径进行引导，以使管体结构10和消融结构20顺畅地移动至或通过病变组织，有效地提高消融手术效率；另一方面，通过第一成像组件30在消融期间对血管内情况和消融情况进行实时成像，可实时根据成像图像判断消融结构20是否作用到血管壁上，可有效地降低消融结构20作用到血管壁上而对血管壁造成损伤的风险，有效地提高消融期间的安全性，还可实时根据成像图像判断病变组织是否存在部分遗漏而未被消融的情况，进而可及时调整激光消融导管的远端端口的位置，以及时对病变组织存在遗漏的部分进行有效、可靠地消融，有效地保障激光消融导管的消融效果和消融准确度，有效地保障并提高激光消融导管的使用性能；另一方面，通过使引导结构40和第一成像组件30交替地穿梭于内管12中而共用一个内管12的内部空间，因此，可在内管12的外径尺寸较小且可在不增加内管12的外径尺寸的情况下，即可满足引导结构40和第一成像组件30的穿设空间需要，也即可在激光消融导管尺寸较小且可在不增加导管结构的外径尺寸的情况下即可实现引导结构40和第一成像组件30的设置，也即在保障激光消融导管通过性能和推送性能的同时，还可实现引导结构40和第一成像组件30的搭载，有效地保障并提高激光消融导管的使用性能。Therefore, by making the guide structure 40 and the first imaging assembly 30 alternately shuttle in the inner tube 12, on the one hand, the guide structure 40 guides the moving paths of the tube structure 10 and the ablation structure 20, so that the tube structure 10 and the ablation structure 20 smoothly move to or through the diseased tissue, effectively improving the efficiency of the ablation operation; on the other hand, the first imaging component 30 performs real-time imaging of the intravascular situation and the ablation situation during the ablation period, and can judge according to the imaging image in real time Whether the ablation structure 20 acts on the blood vessel wall can effectively reduce the risk of damage to the blood vessel wall caused by the ablation structure 20 acting on the blood vessel wall, effectively improve the safety during ablation, and judge whether the diseased tissue is real-time based on the imaging image In the case of partial omission but not ablation, the position of the distal port of the laser ablation catheter can be adjusted in time to effectively and reliably ablate the part of the diseased tissue that is missed, effectively ensuring the ablation effect of the laser ablation catheter and The ablation accuracy effectively guarantees and improves the performance of the laser ablation catheter; on the other hand, by making the guide structure 40 and the first imaging assembly 30 shuttle alternately in the inner tube 12, the inner space of the inner tube 12 is shared, so , the outer diameter of the inner tube 12 can be relatively small and can meet the penetration space requirements of the guide structure 40 and the first imaging component 30 without increasing the outer diameter of the inner tube 12, that is, the The size of the laser ablation catheter is small and the setting of the guide structure 40 and the first imaging component 30 can be realized without increasing the outer diameter of the catheter structure, that is, while ensuring the passing performance and pushing performance of the laser ablation catheter, The loading of the guiding structure 40 and the first imaging component 30 can also be realized, effectively ensuring and improving the performance of the laser ablation catheter.

在此需要说明的是，消融过程通常为一边前进一边消融，消融期间，第一成像组件30可以随着激光消融导管同步移动，以保障第一成像组件30对消融情况和血管内情况的成像效果，有效地降低在消融期间因消融结构20对第一成像组件30的隔档致使成像效果差甚至无法成像的风险，有效地保障第一成像组件30的使用性能。It should be noted here that the ablation process is usually ablation while advancing. During ablation, thefirst imaging component 30 can move synchronously with the laser ablation catheter to ensure the imaging effect of thefirst imaging component 30 on the ablation situation and the intravascular situation , effectively reducing the risk of poor or even impossible imaging due to the blocking of thefirst imaging component 30 by theablation structure 20 during the ablation period, and effectively ensuring the performance of thefirst imaging component 30 .

优选地，请参阅图7，第一成像组件30的远端到达/移动到内管12的远端时，第一成像组件30能够经由内管12的远端管口获取图像、成像。如此，可有效地降低在消融期间因消融结构20对第一成像组件30的隔档致使成像效果差甚至无法成像的风险，有效地保障第一成像组件30对消融情况和血管内情况的成像效果，有效地保障第一成像组件30的使用性能。Preferably, please refer to FIG. 7 , when the distal end of thefirst imaging component 30 reaches/moves to the distal end of theinner tube 12 , thefirst imaging component 30 can acquire and form images through the distal nozzle of theinner tube 12 . In this way, the risk of poor or even impossible imaging due to the blocking of thefirst imaging component 30 by theablation structure 20 during ablation can be effectively reduced, and the imaging effect of thefirst imaging component 30 on ablation conditions and intravascular conditions can be effectively guaranteed , to effectively guarantee the performance of thefirst imaging component 30 .

实施例三Embodiment three

本实施例与实施例一的区别在于：The difference between this embodiment and Embodiment 1 is:

请参阅图6，在本实施例中，内管12的远端管口设有密封结构80。在此需要说明的是，此时，激光消融导管不设置引导结构40，直接通过医护人员手动控制管体结构10和消融结构20的移动路径，以使管体结构10和消融结构20移动至病变组织位置。Please refer to FIG. 6 , in this embodiment, the distal nozzle of theinner tube 12 is provided with a sealingstructure 80 . It should be noted here that, at this time, the laser ablation catheter is not provided with a guidingstructure 40, and the movement paths of thetube structure 10 and theablation structure 20 are directly controlled manually by the medical staff, so that thetube structure 10 and theablation structure 20 move to the lesion organization location.

通过采用上述方案，通过于内管12的远端管口设置密封结构80，以对内管12的远端端口进行密封，可有效地降低血液从远端端口进入内管12的管腔中的风险，从而有效地降低血液对内管12中加载的医疗器械的使用效果造成影响的风险，有效地保障激光消融导管的使用性能。By adopting the above scheme, by setting the sealingstructure 80 at the distal mouth of theinner tube 12 to seal the distal port of theinner tube 12, the risk of blood entering the lumen of theinner tube 12 from the distal port can be effectively reduced. risk, thereby effectively reducing the risk of blood affecting the use effect of the medical device loaded in theinner tube 12, and effectively ensuring the performance of the laser ablation catheter.

具体地，在一种可能的实施方式中，密封结构80由显影材料制成，例如，密封结构80为不锈钢头。如此，通过设置密封结构80由显影材料制成，可在特定的影像环境下，例如在X光的照射下，使得密封结构80具有显影效果，而呈高亮显示，进而在激光消融导管的远端进入血管内时，可通过密封结构80实时追踪激光消融导管的远端在血管中的位置，方便医护人员对激光消融导管的远端进行观测、定位；在另外一种可能的实施方式中，密封结构80由透光材质制成，例如FEP、PTFE、PC等材质，如此，可使得密封结构80具有良好的透光性能，进而利于第一成像组件30的探测光线从内管12的远端管口通过密封结构80出射至管体结构10外部以对前向进行成像，有效地保障第一成像组件30的成像效果，有效地保障第一成像组件30的使用性能。本实施方式对此不做限制。Specifically, in a possible implementation manner, the sealingstructure 80 is made of a developing material, for example, the sealingstructure 80 is a stainless steel head. In this way, by arranging the sealingstructure 80 to be made of a developing material, the sealingstructure 80 can have a developing effect and be highlighted in a specific imaging environment, such as under the irradiation of X-rays, so that it can be displayed in the distance of the laser ablation catheter. When the end of the laser ablation catheter enters the blood vessel, the position of the distal end of the laser ablation catheter in the blood vessel can be tracked in real time through the sealingstructure 80, which is convenient for medical staff to observe and locate the distal end of the laser ablation catheter; in another possible implementation mode, The sealingstructure 80 is made of a light-transmitting material, such as FEP, PTFE, PC and other materials. In this way, the sealingstructure 80 can have good light-transmitting performance, which in turn facilitates the detection of light from thefirst imaging component 30 from the far end of theinner tube 12. The nozzle exits through the sealingstructure 80 to the outside of thetube structure 10 to image the forward direction, effectively ensuring the imaging effect of thefirst imaging component 30 and effectively ensuring the performance of thefirst imaging component 30 . This embodiment does not limit this.

实施例四Embodiment four

本实施例与实施例一的区别在于：The difference between this embodiment and Embodiment 1 is:

请参阅图2，在本实施例中，各消融结构20的第一光纤21集束至引导结构40远离第一成像组件30的一侧。Referring to FIG. 2 , in this embodiment, the firstoptical fibers 21 of eachablation structure 20 are bundled to the side of the guidingstructure 40 away from thefirst imaging component 30 .

通过采用上述方案，通过将各消融结构20的第一光纤21集束至引导结构40远离第一成像组件30的一侧，可有效地第一光纤21对第一成像组件30的探射光线遮挡而影响成像效果的风险，有效地保障第一成像组件30的成像效果，有效地保障第一成像组件30的使用性能。By adopting the above solution, by bundling the firstoptical fibers 21 of eachablation structure 20 to the side of theguide structure 40 away from thefirst imaging component 30, the firstoptical fibers 21 can effectively block the probe light of thefirst imaging component 30 and thus The risk of affecting the imaging effect effectively guarantees the imaging effect of thefirst imaging component 30 and effectively guarantees the performance of thefirst imaging component 30 .

具体地，可通过捏束的方式使得各消融结构20的第一光纤21捏束于引导结构40远离第一成像组件30的一侧，比如，可使用金属箍进行捏束。如此，将各消融结构20的第一光纤21集束的方式十分简单，便于操作。Specifically, the firstoptical fiber 21 of eachablation structure 20 can be pinched on the side of theguide structure 40 away from thefirst imaging component 30 by means of pinching, for example, a metal ferrule can be used for pinching. In this way, the manner of bundling the firstoptical fibers 21 of eachablation structure 20 is very simple and easy to operate.

具体地，第一成像组件30不凸出于第一光纤21的捏束部。基于此，可有效地第一光纤21的捏束部对第一成像组件30的探射光线遮挡而影响成像效果的风险，有效地保障第一成像组件30的成像效果，有效地保障第一成像组件30的使用性能。Specifically, thefirst imaging component 30 does not protrude from the pinched portion of the firstoptical fiber 21 . Based on this, the risk of affecting the imaging effect due to the beam pinching portion of the firstoptical fiber 21 blocking the probe light of thefirst imaging component 30 can be effectively guaranteed, and the imaging effect of thefirst imaging component 30 can be effectively guaranteed, and thefirst imaging component 30 can be effectively guaranteed. Performance of thecomponent 30.

实施例五Embodiment five

本实施例与实施例一的区别在于：The difference between this embodiment and Embodiment 1 is:

请参阅图8，在本实施例中，外管11设有与第二成像组件60相对设置并将外管11的内部连通至外部的探测口111。Please refer to FIG. 8 , in this embodiment, theouter tube 11 is provided with adetection port 111 disposed opposite to thesecond imaging assembly 60 and communicating the inside of theouter tube 11 to the outside.

通过采用上述方案，通过于外管11设置与第二成像组件60相对的探测口111，有效地降低外管11对第二成像组件60的探射信号阻隔致使成像效果较差的风险，利于第二成像组件60的探测信号顺利地通过探测口111朝向管体结构10外部发射，有效地保障第二成像组件60的成像效果，有效地保障第二成像组件60的使用性能。By adopting the above scheme, by setting thedetection port 111 opposite to thesecond imaging component 60 on theouter tube 11, the risk of poor imaging effect due to the blocking of the detection signal of thesecond imaging component 60 by theouter tube 11 is effectively reduced, which is beneficial to thesecond imaging component 60. The detection signal of thesecond imaging component 60 is smoothly emitted toward the outside of thetubular structure 10 through thedetection port 111 , effectively ensuring the imaging effect of thesecond imaging component 60 and effectively ensuring the performance of thesecond imaging component 60 .

实施例六Embodiment six

本实施例与实施例一的区别在于：The difference between this embodiment and Embodiment 1 is:

请参阅图2，在本实施例中，外管11和内管12之间灌注有机液体或凝胶。Please refer to FIG. 2 , in this embodiment, an organic liquid or gel is perfused between theouter tube 11 and theinner tube 12 .

通过采用上述方案，通过于外管11和内管12之间灌注有机液体或凝胶，如此，可通过有机液体或凝胶将消融结构20、内管12以及外管11连接成一体，使得激光消融导管不易折断，有效地保障激光消融导管的使用性能。By adopting the above scheme, by pouring an organic liquid or gel between theouter tube 11 and theinner tube 12, theablation structure 20, theinner tube 12 and theouter tube 11 can be connected into one body through the organic liquid or gel, so that the laser The ablation catheter is not easy to break, which effectively guarantees the performance of the laser ablation catheter.

具体地，在多段式光纤的激光消融导管设置侧向成像的第一成像组件30时，有机液体和凝胶为具有较低的光阻抗的有机液体，如此，使得第一成像组件30的探测光线顺利地通过有机液体或凝胶而出射至管体结构10外，有效地降低探测光线被有机液体或凝胶遮挡过多而影响成像效果的风险，有效地保障第一成像组件30的使用性能，有效地保障激光消融导管的使用性能。Specifically, when thefirst imaging component 30 for lateral imaging is set in the laser ablation catheter of the multi-segment optical fiber, the organic liquid and the gel are organic liquids with lower optical impedance, so that the detection light of thefirst imaging component 30 Smoothly passing through the organic liquid or gel to exit thetubular structure 10, effectively reducing the risk of the detection light being too much blocked by the organic liquid or gel and affecting the imaging effect, effectively ensuring the performance of thefirst imaging component 30, Effectively guarantee the performance of the laser ablation catheter.

具体地，在多段式光纤的激光消融导管设置第二成像组件60时，有机液体为超声波耦合液或凝胶为低声抗凝胶。如此，在通过有机液体或凝胶对第二成像组件60进行固定的同时，还可有效地保障第二成像组件60的探测信号顺利地通过有机液体或凝胶朝向管体结构10外部发射，有效地保障第二成像组件60的成像效果，有效地保障第二成像组件60的使用性能。Specifically, when thesecond imaging component 60 is installed in the laser ablation catheter of the multi-segment optical fiber, the organic liquid is an ultrasonic coupling liquid or the gel is a low-acoustic anti-gel. In this way, while thesecond imaging component 60 is fixed by the organic liquid or gel, it can also effectively ensure that the detection signal of thesecond imaging component 60 is smoothly emitted towards the outside of thetubular structure 10 through the organic liquid or gel, effectively The imaging effect of thesecond imaging component 60 can be ensured effectively, and the performance of thesecond imaging component 60 can be effectively guaranteed.

以上仅为本申请的较佳实施例而已，并不用以限制本申请，凡在本申请的精神和原则之内所作的任何修改、等同替换或改进等，均应包含在本申请的保护范围之内。The above are only preferred embodiments of the application, and are not intended to limit the application. Any modification, equivalent replacement or improvement made within the spirit and principles of the application shall be included in the protection scope of the application. Inside.

Claims (10)

Translated fromChinese

1.一种激光消融导管，其特征在于，包括：1. A laser ablation catheter, characterized in that, comprising:管体结构，包括外管，以及设于所述外管内部的内管；a pipe body structure, including an outer pipe, and an inner pipe disposed inside the outer pipe;消融结构，设于所述内管和所述外管之间，且设有至少一个，所述消融结构包括第一光纤和连接于所述第一光纤远端的第二光纤，所述第二光纤的截面积大于所述第一光纤的截面积，所述第二光纤用于对所述第一光纤的出射光进行扩束，并经由扩束光对病变组织进行消融。An ablation structure is arranged between the inner tube and the outer tube, and at least one is provided, the ablation structure includes a first optical fiber and a second optical fiber connected to the distal end of the first optical fiber, the second The cross-sectional area of the optical fiber is larger than that of the first optical fiber, and the second optical fiber is used to expand the outgoing light of the first optical fiber and ablate the diseased tissue through the expanded beam.2.如权利要求1所述的激光消融导管，其特征在于，所述第一光纤和所述第二光纤之间设有过渡光纤段，所述过渡光纤段的径向尺寸在靠近所述第二光纤的方向上渐扩设置。2. The laser ablation catheter according to claim 1, wherein a transition fiber segment is provided between the first optical fiber and the second fiber, and the radial dimension of the transition fiber segment is close to the first optical fiber. The gradual expansion is set in the direction of the two optical fibers.3.如权利要求1所述的激光消融导管，其特征在于，所述激光消融导管还包括设于所述内管和所述外管之间的调整结构，所述调整结构能够带动所述管体结构的远端和所述消融结构的远端弯曲。3. The laser ablation catheter according to claim 1, wherein the laser ablation catheter further comprises an adjustment structure arranged between the inner tube and the outer tube, and the adjustment structure can drive the tube The distal end of the body structure and the distal end of the ablation structure are curved.4.如权利要求1所述的激光消融导管，其特征在于，所述激光消融导管还包括第一成像组件和引导结构，所述第一成像组件用于实时成像，所述引导结构用于导引所述管体结构和所述消融结构的移动路径；4. The laser ablation catheter according to claim 1, wherein the laser ablation catheter further comprises a first imaging component and a guiding structure, the first imaging component is used for real-time imaging, and the guiding structure is used for guiding guiding the moving paths of the tube structure and the ablation structure;所述第一成像组件和所述引导结构同时穿设于所述内管中，所述第一成像组件相对于所述内管相对固定，所述第一成像组件不凸出于所述第一光纤的远端端面；The first imaging component and the guiding structure are passed through the inner tube at the same time, the first imaging component is relatively fixed relative to the inner tube, and the first imaging component does not protrude from the first the distal end face of the optical fiber;或，所述第一成像组件和所述引导结构交替穿设于所述内管中。Or, the first imaging component and the guiding structure are alternately passed through the inner tube.5.如权利要求4所述的激光消融导管，其特征在于，所述第一成像组件和所述引导结构同时穿设于所述内管中，所述内管的内部分隔形成第一管腔和第二管腔，所述第一成像组件穿设于所述第一管腔中，所述引导结构穿梭于所述第二管腔中。5. The laser ablation catheter according to claim 4, characterized in that, the first imaging component and the guiding structure are penetrated in the inner tube at the same time, and the internal partition of the inner tube forms a first lumen and a second lumen, the first imaging component passes through the first lumen, and the guiding structure shuttles through the second lumen.6.如权利要求5所述的激光消融导管，其特征在于，所述第一管腔的中心线偏离所述管体结构的中心线设置；6. The laser ablation catheter according to claim 5, wherein the centerline of the first lumen deviates from the centerline of the tubular structure;和/或，所述内管的外径在靠近远端的方向渐缩设置；And/or, the outer diameter of the inner tube is tapered in a direction close to the distal end;和/或，所述第一管腔不凸出于所述第一光纤的远端端面。And/or, the first lumen does not protrude from the distal end face of the first optical fiber.7.如权利要求1-6中任一项所述的激光消融导管，其特征在于，所述激光消融导管还包括设于所述外管和所述内管之间的至少一个第二成像组件，所述第二成像组件不凸出于所述第一光纤的远端端面，用于实时成像；7. The laser ablation catheter according to any one of claims 1-6, wherein the laser ablation catheter further comprises at least one second imaging assembly disposed between the outer tube and the inner tube , the second imaging component does not protrude from the distal end face of the first optical fiber, for real-time imaging;当所述第二成像组件设有多个时，多个所述第二成像组件呈圆周阵列排布。When there are multiple second imaging components, the multiple second imaging components are arranged in a circular array.8.如权利要求7所述的激光消融导管，其特征在于，所述激光消融导管还包括套设于各所述第一光纤外的安装套，各所述第二成像组件分别安装于所述安装套的外周；8. The laser ablation catheter according to claim 7, characterized in that, the laser ablation catheter further comprises a mounting sleeve sleeved outside each of the first optical fibers, and each of the second imaging components is respectively installed on the the periphery of the mounting sleeve;当所述第二成像组件设有多个时，所述安装套为多边形管状，各所述第二成像组件分别安装在所述安装套的各侧面。When there are multiple second imaging assemblies, the installation sleeve is polygonal tube shape, and each second imaging assembly is installed on each side of the installation sleeve.9.如权利要求8所述的激光消融导管，其特征在于，所述第二成像组件包括连接于所述安装套背离所述内管一侧的芯片，以及连接于所述芯片背离所述安装套一侧且与所述芯片电连接的至少一个超声换能器。9. The laser ablation catheter according to claim 8, wherein the second imaging component comprises a chip connected to the side of the mounting sleeve facing away from the inner tube, and connected to the chip facing away from the mounting sleeve. at least one ultrasonic transducer on one side and electrically connected to the chip.10.如权利要求9所述的激光消融导管，其特征在于，所述超声换能器设有多个，多个所述超声换能器相互间隔设置；10. The laser ablation catheter according to claim 9, characterized in that there are multiple ultrasonic transducers, and the plurality of ultrasonic transducers are spaced from each other;或，所述超声换能器为压电微机械超声换能器；Or, the ultrasonic transducer is a piezoelectric micromachined ultrasonic transducer;或，所述外管设有与所述第二成像组件相对设置并将所述外管的内部连通至外部的探测口；Or, the outer tube is provided with a detection port opposite to the second imaging component and communicating the inside of the outer tube to the outside;或，所述外管的至少与所述第二成像组件相对设置的部分由具有超声耦合特性的材质制成。Or, at least a part of the outer tube opposite to the second imaging component is made of a material with ultrasonic coupling properties.

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