CN111249044A

Movatterモバイル変換

Info

Publication number: CN111249044A
Application number: CN202010203737.9A
Authority: CN
Inventors: 李鹏; 赵彦; 张澍田; 韦建宇; 沈正华; 冯明浩; 李常青; 冷德嵘
Original assignee: Beijing Friendship Hospital; Micro Tech Nanjing Co Ltd
Current assignee: Beijing Friendship Hospital; Micro Tech Nanjing Co Ltd
Priority date: 2020-03-20
Filing date: 2020-03-20
Publication date: 2020-06-09
Also published as: WO2021185046A1

Abstract

Translated fromChinese

本发明的实施例提供了一种支架及置入系统，涉及医疗器械技术领域。本发明的实施例提供的支架具有相对的近端和远端，沿远端到近端的方向上，支架包括依次连接的第一大径段、第一连接段、中间段、第二连接段以及第二大径段。沿远端到近端的方向，第一连接段的外径逐渐减小，因此在对支架进行径向压缩以将支架装入置入器中时，沿第一连接段的轴线，中间段、第一连接段以及第一大径段上各处位于不同轴向位置，因此压缩后第一连接段处的厚度更小，从而有助于减小安装时与置入器的径向挤压力，进而减小支架与置入器之间的摩擦力，使得在不增大置入器内径的前提下能够装入尺寸更大的支架。

Embodiments of the present invention provide a stent and an implantation system, which relate to the technical field of medical devices. The stent provided by the embodiment of the present invention has opposite proximal ends and distal ends, and along the direction from the distal end to the proximal end, the stent includes a first large-diameter section, a first connecting section, an intermediate section, and a second connecting section that are connected in sequence and the second largest diameter segment. From the distal end to the proximal end, the outer diameter of the first connecting section gradually decreases, so when the stent is radially compressed to fit the stent into the implanter, along the axis of the first connecting section, the middle section, The first connecting section and the first large-diameter section are located at different axial positions, so the thickness of the first connecting section after compression is smaller, which helps to reduce the radial extrusion force with the implanter during installation , thereby reducing the frictional force between the stent and the implanter, so that a stent with a larger size can be installed without increasing the inner diameter of the implanter.

Description

Translated fromChinese

一种支架及置入系统A stent and placement system

技术领域technical field

本发明涉及医疗器械技术领域，具体而言，涉及一种支架及置入系统。The present invention relates to the technical field of medical devices, in particular, to a stent and an implantation system.

背景技术Background technique

在肿瘤病程中，由于肿瘤的直接浸润或压迫引起梗阻，例如在消化道恶性肿瘤的病程中，食管恶性肿瘤造成食管狭窄，胃、十二指肠降部、胰胆系列肿瘤和胃癌手术后吻合口狭窄，结肠恶性肿瘤梗阻和结肠手术后吻合口狭窄等，面对狭窄或梗阻等疾病，目前常用的方法是在狭窄和梗阻部位植入一枚支架，以保证管腔的畅通性。In the course of the tumor, the obstruction is caused by the direct infiltration or compression of the tumor. For example, in the course of the malignant tumor of the digestive tract, the malignant tumor of the esophagus causes esophageal stricture, and the anastomosis of the stomach, descending duodenum, pancreatobiliary series tumors and gastric cancer after surgery Oral stenosis, colon malignant tumor obstruction and anastomotic stenosis after colon surgery, etc. In the face of stenosis or obstruction and other diseases, the commonly used method is to implant a stent at the stenosis and obstruction site to ensure the smoothness of the lumen.

现有的支架根据置入方式的不同分为TTS(Through The Scope)支架和OTW(Over The Wire)支架。OTW支架即支架置入器不经内镜钳道，只经导丝和X射线的辅助观察到达病变位置，因此能够置入外径更大的支架，支架支撑力强、防移位效果好，但是在置入过程中医生和患者长时间暴露在X射线中，对人体造成损害；TTS支架即支架置入器经内镜钳道，通过内镜直视观察置入，从而能够更好地确认支架置入位置，但是TTS置入器外径小，因此其配套支架存在外径小、支撑力差、置入后容易发生位移等问题。Existing stents are divided into TTS (Through The Scope) stents and OTW (Over The Wire) stents according to different placement methods. The OTW stent is the stent implanter that does not go through the endoscopic forceps, but only reaches the lesion location through the auxiliary observation of guide wire and X-ray. Therefore, a stent with a larger outer diameter can be placed, and the stent has strong supporting force and good anti-displacement effect. However, during the implantation process, doctors and patients are exposed to X-rays for a long time, which will cause damage to the human body; the TTS stent, the stent implanter, is placed through the endoscopic forceps and observed through the endoscope, so as to better confirm the placement. The stent is placed in the position, but the outer diameter of the TTS implanter is small, so the supporting stent has problems such as small outer diameter, poor supporting force, and easy displacement after placement.

发明内容SUMMARY OF THE INVENTION

本发明的目的包括，例如，提供了一种支架，其能够更加方便地装入置入器中，有助于通过内镜钳道置入具有更大尺寸的支架，且具有防止移位的功能。Objects of the present invention include, for example, to provide a stent that can be more easily inserted into the implanter, facilitates the placement of stents of larger size through the endoscopic forceps, and has the function of preventing displacement .

本发明的目的还包括，提供了一种置入系统，该置入系统包括上述的支架。Another object of the present invention is to provide an implantation system, which includes the above-mentioned stent.

本发明的实施例可以这样实现：Embodiments of the present invention can be implemented as follows:

本发明的实施例提供了一种支架，所述支架具备相对的远端以及近端，沿所述远端到所述近端的方向上，所述支架包括依次连接的第一大径段、第一连接段、中间段、第二连接段以及第二大径段；An embodiment of the present invention provides a stent, the stent has opposite distal ends and proximal ends, and along the direction from the distal end to the proximal end, the stent includes a first large-diameter section, a first large-diameter section, a a first connecting section, an intermediate section, a second connecting section and a second large diameter section;

沿所述远端到所述近端的方向，所述第一连接段的外径逐渐减小；along the direction from the distal end to the proximal end, the outer diameter of the first connecting segment gradually decreases;

所述中间段、所述第二连接段以及所述第二大径段形成限位台阶，所述限位台阶用于防止移位。The middle section, the second connecting section and the second large diameter section form a limit step, and the limit step is used to prevent displacement.

可选地，所述第一连接段的外壁与所述中间段的外壁之间具有夹角α；所述第二连接段的外壁与所述中间段的外壁之间具有夹角β；Optionally, there is an included angle α between the outer wall of the first connecting section and the outer wall of the intermediate section; there is an included angle β between the outer wall of the second connecting section and the outer wall of the intermediate section;

其中，α-β≥20°Among them, α-β≥20°

可选地，90°＜α≤180°。Optionally, 90°<α≤180°.

可选地，115°≤α≤155°。Optionally, 115°≤α≤155°.

可选地，60°≤β≤120°。Optionally, 60°≤β≤120°.

可选地，所述第一连接段呈锥状。Optionally, the first connecting segment is tapered.

可选地，所述第一大径段与所述第一连接段的连接处圆弧过渡。Optionally, an arc transition at the connection between the first large diameter section and the first connecting section.

可选地，所述第一大径段呈圆筒状。Optionally, the first large diameter section is cylindrical.

可选地，所述第二连接段的外壁与所述中间段的外壁之间具有夹角β，80°≤β≤100°。Optionally, there is an included angle β between the outer wall of the second connecting segment and the outer wall of the intermediate segment, 80°≤β≤100°.

可选地，所述第二连接段垂直于所述中间段。Optionally, the second connecting segment is perpendicular to the intermediate segment.

可选地，所述第一大径段、所述第一连接段、所述中间段、所述第二连接段和所述第二大径段均覆膜。Optionally, the first large-diameter section, the first connecting section, the intermediate section, the second connecting section and the second large-diameter section are all covered with a film.

可选地，所述第一大径段、所述第一连接段、所述中间段、所述第二连接段以及所述第二大径段均关于预设轴线对称设置。Optionally, the first large-diameter section, the first connecting section, the intermediate section, the second connecting section, and the second large-diameter section are all symmetrically arranged about a preset axis.

可选地，所述中间段的径向尺寸为R，14mm≤R≤24mm。Optionally, the radial dimension of the middle section is R, 14mm≤R≤24mm.

本发明的实施例还提供了一种置入系统。所述置入系统包括置入器以及上述的支架；所述置入器具有容纳腔，所述支架设置在所述容纳腔内。Embodiments of the present invention also provide an implant system. The implantation system includes an implanter and the above-mentioned bracket; the implanter has a accommodating cavity, and the bracket is arranged in the accommodating cavity.

可选地，所述置入器包括内管、外管和推动件，所述外管套设于所述内管；所述内管包括金属管部，所述金属管部与所述外管之间形成所述容纳腔，所述推动件设置在所述内管与所述外管之间，且所述推动件用于推动位于所述容纳腔内的所述支架。Optionally, the implanter includes an inner tube, an outer tube and a pusher, the outer tube is sleeved on the inner tube; the inner tube includes a metal tube part, the metal tube part and the outer tube The accommodating cavity is formed therebetween, the pushing member is arranged between the inner tube and the outer tube, and the pushing member is used to push the bracket located in the accommodating cavity.

可选地，所述内管的材质为金属。Optionally, the material of the inner tube is metal.

可选地，所述置入器还包括头部，所述头部上设置有相互连通的安装孔与通孔，所述金属管部的远端安装在所述安装孔内，所述通孔与所述内管的内孔连通以形成用于供导丝穿设的通道，所述通孔的径向尺寸小于或者等于所述内孔的径向尺寸。Optionally, the implanter further includes a head, the head is provided with a mounting hole and a through hole that communicate with each other, the distal end of the metal tube is installed in the mounting hole, the through hole is It communicates with the inner hole of the inner tube to form a channel for the guide wire to pass through, and the radial dimension of the through hole is smaller than or equal to the radial dimension of the inner hole.

可选地，所述头部具有对应于所述通孔的第一壁面，所述头部还包括位于所述头部外侧的第二壁面以及连接于所述第一壁面与所述第二壁面之间的连接面，所述连接面为圆弧面。Optionally, the head portion has a first wall surface corresponding to the through hole, and the head portion further includes a second wall surface located outside the head portion and connected to the first wall surface and the second wall surface The connecting surface between them is a circular arc surface.

可选地，所述第二壁面为圆弧面，沿所述头部的远端指向近端的方向，所述第二壁面至所述头部的轴线之间的距离逐渐增大。Optionally, the second wall surface is a circular arc surface, and the distance from the second wall surface to the axis of the head gradually increases along the direction from the distal end of the head to the proximal end.

可选地，所述头部的材质为金属。Optionally, the material of the head is metal.

可选地，所述头部与所述金属管部通过激光焊接固定。Optionally, the head and the metal tube are fixed by laser welding.

可选地，所述头部的近端具有抵接面，所述抵接面用于与所述外管的远端抵接定位。Optionally, the proximal end of the head has an abutment surface, and the abutment surface is used for abutting and positioning with the distal end of the outer tube.

可选地，所述头部还包括凸出所述抵接面设置的卡块，所述卡块与所述抵接面形成定位空间，所述定位空间用于容纳所述外管的远端。Optionally, the head further includes a blocking block disposed protruding from the abutting surface, the blocking block and the abutting surface form a positioning space, and the positioning space is used for accommodating the distal end of the outer tube .

可选地，所述置入器上设置有释放标识。Optionally, a release sign is provided on the inserter.

本发明实施例的支架及置入系统的有益效果包括，例如：The beneficial effects of the stent and the implantation system according to the embodiments of the present invention include, for example:

本发明的实施例提供了一种支架，其具备相对的远端和近端。沿远端到近端的方向上，支架包括依次连接的第一大径段、第一连接段、中间段、第二连接段以及第二大径段。沿远端到近端的方向，第一连接段的外径逐渐减小，因此在对支架进行径向压缩以将支架装入置入器中时，沿第一连接段的轴线，中间段、第一连接段以及第一大径段上各处位于不同轴向位置，因此压缩后第一连接段处的厚度更小，从而有助于减小安装时与置入器的径向挤压力，进而减小支架与置入器之间的摩擦力，使得在不增大置入器内径的前提下能够装入尺寸更大的支架。同时中间段、第二连接段以及第二大径段形成限位台阶，支架置入人体的管腔中后，人体组织向中间段生长从而在管腔的轴向上与限位台阶抵触，进而有助于防止支架移位。Embodiments of the present invention provide a stent having opposing distal and proximal ends. From the distal end to the proximal end, the stent includes a first large diameter section, a first connecting section, an intermediate section, a second connecting section and a second large diameter section which are connected in sequence. From the distal end to the proximal end, the outer diameter of the first connecting section gradually decreases, so when the stent is radially compressed to fit the stent into the implanter, along the axis of the first connecting section, the middle section, The first connecting section and the first large-diameter section are located at different axial positions, so the thickness of the first connecting section after compression is smaller, which helps to reduce the radial extrusion force with the implanter during installation , thereby reducing the frictional force between the stent and the implanter, so that a stent with a larger size can be installed without increasing the inner diameter of the implanter. At the same time, the middle section, the second connecting section and the second large-diameter section form a limit step. After the stent is placed in the lumen of the human body, the human tissue grows toward the middle section and collides with the limit step in the axial direction of the lumen. Helps prevent stent displacement.

本发明的实施例还提供了一种置入系统，该置入系统包括上述的支架，因此也具有能够在不增大置入器内径的基础上实现尺寸更大的支架的置入，特别是尺寸大、同时又可以防止移位的支架的置入。Embodiments of the present invention also provide an implantation system, which includes the above-mentioned stent, and therefore also has the ability to realize the placement of a stent with a larger size without increasing the inner diameter of the implanter, especially Placement of stents that are large in size and at the same time prevent displacement.

附图说明Description of drawings

为了更清楚地说明本发明实施例的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，应当理解，以下附图仅示出了本发明的某些实施例，因此不应被看作是对范围的限定，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相关的附图。In order to illustrate the technical solutions of the embodiments of the present invention more clearly, the following briefly introduces the accompanying drawings used in the embodiments. It should be understood that the following drawings only show some embodiments of the present invention, and therefore do not It should be regarded as a limitation of the scope, and for those of ordinary skill in the art, other related drawings can also be obtained according to these drawings without any creative effort.

图1为本发明的实施例提供的支架的结构示意图；1 is a schematic structural diagram of a stent provided by an embodiment of the present invention;

图2为本发明的实施例提供的置入系统的局部结构示意图；2 is a schematic diagram of a partial structure of an implantation system provided by an embodiment of the present invention;

图3为本发明的实施例提供的第二种支架的局部结构示意图；3 is a schematic diagram of a partial structure of a second type of stent provided by an embodiment of the present invention;

图4为本发明的实施例提供的第三种支架的局部结构示意图；4 is a schematic partial structure diagram of a third type of stent provided by an embodiment of the present invention;

图5为本发明的实施例提供的支架中第一大径段和第一连接段的连接处的局部结构示意图；5 is a partial structural schematic diagram of the connection between the first large-diameter section and the first connecting section in the stent according to an embodiment of the present invention;

图6为本发明的实施例提供的第四种支架的局部结构示意图；6 is a schematic partial structure diagram of a fourth stent provided by an embodiment of the present invention;

图7为本发明的实施例提供的置入系统中置入器的整体结构示意图；7 is a schematic diagram of the overall structure of an implanter in an implantation system provided by an embodiment of the present invention;

图8为本发明的实施例提供的置入系统中置入器的局部结构示意图；8 is a schematic diagram of a partial structure of an implanter in an implantation system provided by an embodiment of the present invention;

图9为本发明的实施例提供的置入系统中置入器处于释放状态时的结构示意图；9 is a schematic structural diagram of the implanter in the implantation system provided by an embodiment of the present invention when the implanter is in a released state;

图10为图9中Ⅹ处的局部结构放大图。FIG. 10 is an enlarged view of a part of the structure at X in FIG. 9 .

图标：10-置入系统；100-支架；110-第一杯口段；111-第一大径段；112-第一连接段；113-过渡段；120-中间段；130-第二杯口段；131-第二连接段；132-第二大径段；140-限位台阶；200-置入器；210-内管；211-金属管部；220-外管；230-推动件；231-中管；232-助推管；240-头部；241-安装孔；242-通孔；243-第一壁面；244-第二壁面；245-连接面；246-抵接面；247-卡块；251-第一操作手柄；252-第二操作手柄；253-锁扣；254-锁紧螺母；260-容纳腔；270-导丝。Icons: 10-insertion system; 100-stand; 110-first cup mouth section; 111-first large diameter section; 112-first connecting section; 113-transition section; 120-intermediate section; 130-second cup Mouth section; 131-second connecting section; 132-second large diameter section; 140-limiting step; 200-injector; 210-inner tube; 211-metal tube part; 220-outer tube; 230-pusher ; 231 - middle tube; 232 - booster tube; 240 - head; 241 - mounting hole; 242 - through hole; 243 - first wall surface; 244 - second wall surface; 245 - connecting surface; 246 - abutting surface; 247-block; 251-first operating handle; 252-second operating handle; 253-lock; 254-lock nut; 260-accommodating cavity; 270-guide wire.

具体实施方式Detailed ways

为使本发明实施例的目的、技术方案和优点更加清楚，下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本发明一部分实施例，而不是全部的实施例。通常在此处附图中描述和示出的本发明实施例的组件可以以各种不同的配置来布置和设计。In order to make the purposes, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments These are some embodiments of the present invention, but not all embodiments. The components of the embodiments of the invention generally described and illustrated in the drawings herein may be arranged and designed in a variety of different configurations.

因此，以下对在附图中提供的本发明的实施例的详细描述并非旨在限制要求保护的本发明的范围，而是仅仅表示本发明的选定实施例。基于本发明中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。Thus, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the invention as claimed, but is merely representative of selected embodiments of the invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

应注意到：相似的标号和字母在下面的附图中表示类似项，因此，一旦某一项在一个附图中被定义，则在随后的附图中不需要对其进行进一步定义和解释。It should be noted that like numerals and letters refer to like items in the following figures, so once an item is defined in one figure, it does not require further definition and explanation in subsequent figures.

在本发明的描述中，需要说明的是，若出现术语“上”、“下”、“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，或者是该发明产品使用时惯常摆放的方位或位置关系，仅是为了便于描述本发明和简化描述，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发明的限制。In the description of the present invention, it should be noted that, if the terms "upper", "lower", "inner", "outer", etc. appear, the orientation or positional relationship indicated is based on the orientation or positional relationship shown in the drawings, or It is the orientation or positional relationship that the product of the invention is usually placed in use, only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation , so it should not be construed as a limitation of the present invention.

此外，若出现术语“第一”、“第二”等仅用于区分描述，而不能理解为指示或暗示相对重要性。In addition, where the terms "first", "second" and the like appear, they are only used to differentiate the description, and should not be construed as indicating or implying relative importance.

需要说明的是，在不冲突的情况下，本发明的实施例中的特征可以相互结合。It should be noted that the features in the embodiments of the present invention may be combined with each other without conflict.

图1为本实施例提供的支架100的结构示意图，图2为本实施例提供的置入系统10的局部结构示意图。请结合参考图1和图2，本实施例提供了一种支架100，相应地，提供了一种置入系统10。需要说明的，在本实施例的描述中，“支架”即能够通过置入器200在内镜直视下经内镜钳道置入人体的管腔的支架。FIG. 1 is a schematic structural diagram of astent 100 provided in this embodiment, and FIG. 2 is a partial structural schematic diagram of animplantation system 10 provided in this embodiment. Please refer to FIG. 1 and FIG. 2 in combination, this embodiment provides astent 100 , and accordingly, animplantation system 10 is provided. It should be noted that, in the description of this embodiment, the "stent" refers to a stent that can be inserted into the lumen of the human body through the endoscopic forceps channel under the direct vision of the endoscope through theinserter 200 .

置入系统10包括上述的支架100，同时置入系统10还包括置入器200。置入器200内具有用于容纳支架100的容纳腔260，将支架100装入置入器200中后，通过置入器200经内镜钳道将支架100置入人体的管腔中。同理的，由于置入器200在使用过程中，置入器200的前端会伸入人体内，置入器200的后端设置有把手以供医务人员进行操作，因此，相应地，置入器200中各部件靠近前端的部分称为该部件的远端，靠近后端的部分称为该部件的近端。Theimplantation system 10 includes thestent 100 described above, and theimplantation system 10 further includes animplanter 200 . Theimplanter 200 has anaccommodating cavity 260 for accommodating thestent 100 . After thestent 100 is loaded into theimplanter 200 , thestent 100 is inserted into the lumen of the human body through the endoscopic forceps through theimplanter 200 . Similarly, since the front end of theinserter 200 will protrude into the human body during the use of theinserter 200, and the rear end of theinserter 200 is provided with a handle for medical personnel to operate, accordingly, theinserter 200 is The part of each component in thedevice 200 near the front end is called the distal end of the component, and the part near the rear end is called the proximal end of the component.

支架100具备相对的远端和近端。沿远端到近端的方向上，支架100包括依次连接的第一大径段111、第一连接段112、中间段120、第二连接段131以及第二大径段132。沿远端到近端的方向，第一连接段112的外径逐渐减小，因此在对支架100进行径向压缩以将支架100装入置入器200中时，沿第一连接段112的轴线，中间段120、第一连接段112以及第一大径段111上各处位于不同轴向位置，因此压缩后第一连接段112处的厚度更小，从而有助于减小安装时与置入器200的径向挤压力，进而减小支架100与置入器200之间的摩擦力，使得在不增大置入器200内径的前提下能够装入尺寸更大的支架100，因此能够将较现有TTS支架具有更大尺寸的支架100作为TTS支架，经内镜钳道置入人体内。同时中间段120、第二连接段131以及第二大径段132形成限位台阶140，支架100置入人体的管腔中后，人体组织(即相应管腔的内壁组织)向中间段120生长从而在管腔的延伸方向上与限位台阶140抵触，进而可实现支架100防移位的功能。Stent 100 has opposing distal and proximal ends. From the distal end to the proximal end, thestent 100 includes a firstlarge diameter section 111 , a first connectingsection 112 , anintermediate section 120 , a second connectingsection 131 and a secondlarge diameter section 132 connected in sequence. In the direction from the distal end to the proximal end, the outer diameter of the first connectingsection 112 gradually decreases, so when thestent 100 is radially compressed to fit thestent 100 into theimplanter 200, the outer diameter of the first connectingsection 112 decreases. The axis, themiddle section 120, the first connectingsection 112 and the first large-diameter section 111 are located at different axial positions, so the thickness of the first connectingsection 112 after compression is smaller, which helps to reduce The radial extrusion force of theimplanter 200 reduces the frictional force between thestent 100 and theimplanter 200, so that astent 100 with a larger size can be installed without increasing the inner diameter of theimplanter 200, Therefore, thestent 100 having a larger size than the existing TTS stent can be used as a TTS stent and inserted into the human body through the endoscopic forceps. At the same time, themiddle section 120 , the second connectingsection 131 and the second large-diameter section 132 form alimit step 140 . After thestent 100 is placed in the lumen of the human body, human tissue (ie, the inner wall tissue of the corresponding lumen) grows toward themiddle section 120 As a result, it is in conflict with the limitingstep 140 in the extending direction of the lumen, thereby realizing the function of preventing displacement of thestent 100 .

需要说明的，在本实施例的描述中，“近端”为置入人体后靠近人体外部的一端，“远端”为置入人体后靠近人体内部的一端，例如在人体的食道中置入支架后，支架的近端为支架靠近口腔的一端，支架的远端为支架靠近胃的一端。It should be noted that in the description of this embodiment, the "proximal end" refers to the end that is close to the outside of the human body after being inserted into the human body, and the "distal end" refers to the end that is close to the interior of the human body after being placed in the human body, for example, it is placed in the esophagus of the human body. After stenting, the proximal end of the stent is the end of the stent that is close to the oral cavity, and the distal end of the stent is the end of the stent that is close to the stomach.

下面对本实施例提供的支架100进行进一步地说明：Thebracket 100 provided in this embodiment is further described below:

请结合参照图1和图2，在本实施例中，支架100包括依次设置的第一杯口段110、中间段120和第二杯口段130，中间段120呈圆筒状，第一杯口段110和第二杯口段130的径向尺寸均大于中间段120，从而形成哑铃状外形的支架100。具体的，第一杯口段110位于中间段120的远端，第二杯口段130位于中间段120的近端，即第一杯口段110、中间段120和第二杯口段130沿支架100的远端到近端的方向依次设置。同时，第一杯口段110、中间段120和第二杯口段130采用金属丝编织一体成型制成。Please refer to FIG. 1 and FIG. 2 , in this embodiment, thebracket 100 includes a firstcup opening section 110 , amiddle section 120 and a secondcup opening section 130 arranged in sequence, themiddle section 120 is cylindrical, and the firstcup opening section 120 The radial dimensions of themouth section 110 and the secondcup mouth section 130 are both larger than those of themiddle section 120 , so as to form thestent 100 with a dumbbell shape. Specifically, the firstcup mouth section 110 is located at the distal end of themiddle section 120, and the secondcup mouth section 130 is located at the proximal end of themiddle section 120, that is, the firstcup mouth section 110, themiddle section 120 and the secondcup mouth section 130 are located along the The directions from the distal end to the proximal end of thestent 100 are arranged sequentially. Meanwhile, the firstcup mouth section 110, themiddle section 120 and the secondcup mouth section 130 are integrally formed by braiding metal wires.

第一杯口段110包括第一大径段111和第一连接段112，第一连接段112的两端分别与第一大径段111和中间段120连接，第一大径段111的外径大于中间段120的外径，从而通过第一连接段112实现不同外径尺寸之间的连接过渡。具体的，沿支架100的远端到近端的方向(即图1中由下往上的方向)，第一连接段112的外径逐渐减小，即第一连接段112的近端和远端沿第一连接段112的轴向间隔设置，需要说明的，在本实施例的描述中，“第一连接段112的外径”指第一连接段112上各处至支架100的轴线之间的距离。Thefirst cup section 110 includes a first large-diameter section 111 and a first connectingsection 112 . Both ends of the first connectingsection 112 are connected to the first large-diameter section 111 and themiddle section 120 respectively. The diameter is larger than the outer diameter of themiddle section 120 , so that the connection transition between different outer diameter sizes is realized through the first connectingsection 112 . Specifically, along the direction from the distal end to the proximal end of the stent 100 (ie, the direction from bottom to top in FIG. 1 ), the outer diameter of the first connectingsegment 112 gradually decreases, that is, the proximal end and the distal end of the first connectingsegment 112 The ends are arranged at intervals along the axial direction of the first connectingsection 112. It should be noted that, in the description of this embodiment, the “outer diameter of the first connectingsection 112” refers to the distance from each place on the first connectingsection 112 to the axis of thestent 100. distance between.

由于第一大径段111的外径大于中间段120的外径，因此第一连接段112的近端外径小于第一连接段112的远端外径，中间段120、第一连接段112和第一大径段111在轴向上依次设置，因而当支架100受到径向压缩、外形减小以装入置入器200中时，中间段120、第一连接段112和第一大径段111的各处在轴向上依次设置，即中间段120。第一连接段112和第一大径段111在轴向各处无重叠现象，从而有助于减小安装时与置入器200的径向挤压力，进而减小支架100与置入器200之间的摩擦力，使得在不增大置入器200内径的基础上能够装入尺寸更大的支架100。Since the outer diameter of the first large-diameter section 111 is larger than the outer diameter of themiddle section 120 , the outer diameter of the proximal end of the first connectingsection 112 is smaller than the outer diameter of the distal end of the first connectingsection 112 . Themiddle section 120 and the first connectingsection 112 and the first large-diameter section 111 are arranged in sequence in the axial direction, so when thestent 100 is radially compressed and its shape is reduced to fit into theimplanter 200, theintermediate section 120, the first connectingsection 112 and the first large-diameter section 120 All parts of thesegment 111 are arranged one after the other in the axial direction, namely themiddle segment 120 . The first connectingsection 112 and the first large-diameter section 111 do not overlap anywhere in the axial direction, thereby helping to reduce the radial pressing force between thestent 100 and theimplanter 200 during installation, thereby reducing the size of thestent 100 and the implanter. The friction force between 200 makes it possible to install astent 100 with a larger size on the basis of not increasing the inner diameter of theimplanter 200 .

请参照图1，在本实施例中，第二杯口段130包括第二连接段131和第二大径段132，第二连接段131的两端分别与第二大径段132和中间段120连接，即沿支架100的远端到近端的方向上，第一大径段111、第一连接段112、中间段120、第二连接段131以及第二大径段132依次连接。Referring to FIG. 1 , in this embodiment, the secondcup mouth section 130 includes a second connectingsection 131 and a secondlarge diameter section 132 , and two ends of the second connectingsection 131 are respectively connected to the secondlarge diameter section 132 and the middle section. 120 connection, that is, along the direction from the distal end to the proximal end of thestent 100 , the firstlarge diameter section 111 , the first connectingsection 112 , theintermediate section 120 , the second connectingsection 131 and the secondlarge diameter section 132 are connected in sequence.

中间段120、第二连接段131以及第二大径段132形成限位台阶140，中间段120与第二连接段131之间形成与限位台阶140对应的限位空间，当支架100置入人体的管腔中后，人体组织向限位空间内生长，从而使该人体组织在管腔的延伸方向上与限位台阶140抵触限位，防止支架100在管腔的延伸方向上发生移位情况。可选地，第二连接段131与第二大径段132的连接处设置弧面圆滑过渡，从而可以减小限位台阶140对人体的刺激、损伤，同时也有助于较大尺寸的支架100更加顺利地装入置入器200中。Themiddle section 120 , the second connectingsection 131 and the secondlarge diameter section 132 form alimit step 140 , and a limit space corresponding to thelimit step 140 is formed between themiddle section 120 and the second connectingsection 131 . After entering the lumen of the human body, the human tissue grows into the limiting space, so that the human tissue collides with the limitingstep 140 in the extending direction of the lumen to prevent thestent 100 from being displaced in the extending direction of the lumen Happening. Optionally, the connection between the second connectingsection 131 and the second large-diameter section 132 is provided with a smooth transition of the arc surface, so as to reduce the stimulation and damage of the limitingstep 140 to the human body, and also help thestent 100 with a larger size. more smoothly into theinserter 200.

具体的，第二大径段132呈圆筒状，且第二大径段132与中间段120同轴设置，因此第二大径段132和中间段120在如图1所示的平面内投影形成的轮廓线相互平行。且第一大径段111、第一连接段112、中间段120、第二连接段131和第二大径段132均关于预设轴线对称设置，预设轴线即为第一大径段111、中间段120和第二大径段132的轴线所在的直线。Specifically, the second large-diameter section 132 is cylindrical, and the second large-diameter section 132 and themiddle section 120 are coaxially disposed, so the second large-diameter section 132 and themiddle section 120 are projected on the plane as shown in FIG. 1 . The contour lines formed are parallel to each other. And the firstlarge diameter section 111 , the first connectingsection 112 , theintermediate section 120 , the second connectingsection 131 and the secondlarge diameter section 132 are symmetrically arranged with respect to the preset axis, and the preset axis is the firstlarge diameter section 111 , The straight line where the axes of themiddle section 120 and the secondlarge diameter section 132 are located.

请继续参照图1，在本实施例中，第一连接段112呈锥状，即第一连接段112的外壁为锥面。具体的，第一连接段112的外壁与中间段120的外壁之间具有夹角，即第一连接段112的外壁在如图1所示的平面中所形成轮廓线与中间段120的外壁在如图1所示的平面中所形成的轮廓线交叉形成的夹角，该夹角为α；同理地，第二连接段131的外壁与中间段120的外壁之间也具有夹角，即第二连接段131的外壁在如图1所示的平面中所形成轮廓线与中间段120的外壁在如图1所示的平面中所形成的轮廓线交叉形成的夹角，该夹角为β；α-β≥20°。具体地，90°＜α≤180°，通过将α设置为钝角，有助于减小安装时第一连接段112与置入器200的径向挤压力，进而减小支架100与置入器200之间的摩擦力，使得在不增大置入器200内径的基础上能够更加轻易地将大尺寸的支架100装入置入器200中，进而能够将较现有TTS支架具有更大尺寸的支架100作为TTS支架，经内镜钳道置入人体内。进一步地，115°≤α≤155°。可选地，夹角α为115°、135°或155°。可以理解的，在其他实施例中，也可以根据需求，具体设置夹角的具体数值。具体地，60°≤β≤120°。通过对α以及β具体角度值的设置，有助于同时保证支架100的防移位效果以及装入置入器200的便利性。可选地，夹角β为60°、90°或120°。Please continue to refer to FIG. 1 , in this embodiment, the first connectingsection 112 is tapered, that is, the outer wall of the first connectingsection 112 is a tapered surface. Specifically, there is an included angle between the outer wall of the first connectingsection 112 and the outer wall of theintermediate section 120 , that is, the contour line formed by the outer wall of the first connectingsection 112 in the plane as shown in FIG. The included angle formed by the intersection of the contour lines formed in the plane as shown in FIG. 1 is α; similarly, there is also an included angle between the outer wall of the second connectingsegment 131 and the outer wall of theintermediate segment 120 , that is, The angle formed by the contour line formed by the outer wall of the second connectingsegment 131 in the plane as shown in FIG. 1 and the contour line formed by the outer wall of themiddle section 120 in the plane as shown in FIG. 1 intersects, and the angle is β; α-β≥20°. Specifically, 90°<α≤180°, by setting α to be an obtuse angle, it helps to reduce the radial pressing force between the first connectingsection 112 and theimplanter 200 during installation, thereby reducing the relationship between thestent 100 and theimplanter 200 . The friction force between theimplanters 200 makes it easier to insert the large-sized stent 100 into theimplanter 200 on the basis of not increasing the inner diameter of theimplanter 200, thereby enabling thestent 100 with a larger size than the existing TTS stent. Thesized stent 100 is used as a TTS stent and is placed into the human body through the endoscopic forceps. Further, 115°≤α≤155°. Optionally, the included angle α is 115°, 135° or 155°. It can be understood that, in other embodiments, the specific value of the included angle can also be specifically set according to requirements. Specifically, 60°≤β≤120°. By setting the specific angle values of α and β, it is helpful to ensure the anti-displacement effect of thestent 100 and the convenience of being loaded into theimplanter 200 at the same time. Optionally, the included angle β is 60°, 90° or 120°.

为了进一步保证支架100的防移位效果，第二连接段131的外壁与中间段的外壁之间形成夹角β，80°≤β≤100°。在本实施例中，第二连接段131垂直于中间段120，即第二连接段131和中间段120在如图1所示的平面内的投影形成的轮廓线相互垂直，换言之，在本实施例中，β＝90°。因此第二连接段131沿中间段120的径向延伸，同时第二连接段131垂直第二大径段132设置。可选地，夹角β也可以设置为80°或100°。需要说明的，在本实施例中第二连接段131垂直中间段120设置，可以理解的，在其他实施例中，也可以将设置为第二连接段131与中间段120之间形成锐角的方式(如图3所示)。In order to further ensure the anti-displacement effect of thebracket 100, an angle β is formed between the outer wall of the second connectingsegment 131 and the outer wall of the intermediate segment, 80°≤β≤100°. In this embodiment, the second connectingsection 131 is perpendicular to themiddle section 120, that is, the contour lines formed by the projection of the second connectingsection 131 and themiddle section 120 on the plane as shown in FIG. 1 are perpendicular to each other. In other words, in this embodiment In the example, β=90°. Therefore, the second connectingsection 131 extends along the radial direction of themiddle section 120 , and at the same time, the second connectingsection 131 is arranged perpendicular to the second large-diameter section 132 . Optionally, the included angle β can also be set to 80° or 100°. It should be noted that in this embodiment, the second connectingsection 131 is arranged perpendicular to themiddle section 120. It can be understood that in other embodiments, the second connectingsection 131 and themiddle section 120 can also be arranged to form an acute angle. (As shown in Figure 3).

需要说明的，在本实施例中，第一连接段112呈锥状，可以理解的，在其他实施例中，也可以根据需求，具体设置第一连接段112的形状，例如将第一连接段112设置为沿近端到远端的方向上，外径尺寸逐渐增大的弧面(如图4所示)。需要说明的，当第一连接段112设置为弧面时，第一连接段112与中间段120的夹角即为第一连接段112的切线与中间段120的夹角。It should be noted that, in this embodiment, the first connectingsection 112 is tapered. It is understood that in other embodiments, the shape of the first connectingsection 112 can also be specifically set according to requirements. The 112 is set as an arc surface with a gradually increasing outer diameter along the direction from the proximal end to the distal end (as shown in FIG. 4 ). It should be noted that when the first connectingsegment 112 is set as an arc surface, the angle between the first connectingsegment 112 and theintermediate segment 120 is the angle between the tangent of the first connectingsegment 112 and theintermediate segment 120 .

图5为本实施例提供的支架100中第一大径段111和第一连接段112的连接处的局部结构示意图。请参照图5，进一步地，第一大径段111和第一连接段112的连接处圆弧过渡。具体的，第一杯口段110还包括位于第一大径段111和第一连接段112之间的过渡段113，过渡段113在如图4所示的平面所截得的形状为圆弧状，过渡段113的两端分别与第一大径段111和第一连接段112连接，且第一大径段111、过渡段113和第一连接段112通过金属丝编织一体成型。可以理解的，在其他实施例中，也可以根据需求设置第一大径段111和第一连接段112的连接处的结构，例如将第一大径段111的近端直接与第一连接段112的远端连接，从而在第一大径段111和第一连接段112的连接处形成夹角。FIG. 5 is a partial structural schematic diagram of the connection between the firstlarge diameter section 111 and the first connectingsection 112 in thestent 100 provided in this embodiment. Referring to FIG. 5 , further, the arc transition at the connection between the firstlarge diameter section 111 and the first connectingsection 112 is circular. Specifically, the firstcup mouth section 110 further includes atransition section 113 located between the firstlarge diameter section 111 and the first connectingsection 112 , and the shape of thetransition section 113 intercepted on the plane as shown in FIG. 4 is an arc The two ends of thetransition section 113 are respectively connected with the firstlarge diameter section 111 and the first connectingsection 112, and the firstlarge diameter section 111, thetransition section 113 and the first connectingsection 112 are integrally formed by braiding of metal wires. It can be understood that in other embodiments, the structure of the connection between the first large-diameter section 111 and the first connectingsection 112 can also be set according to requirements, for example, the proximal end of the first large-diameter section 111 is directly connected to the first connecting section. The distal ends of 112 are connected to form an included angle at the connection between the firstlarge diameter section 111 and the first connectingsection 112 .

请结合参照图1和图5，在本实施例中，第一大径段111呈圆筒状，第一大径段111与中间段120同轴设置，因此第一大径段111与中间段120在如图1所示的平面内投影形成的轮廓线相互平行。需要说明的，此处并不对第一大径段111的形状进行限制，可以理解的，在其他实施例中，也可以根据需求设置第一大径段111的形状，例如将第一大径段111设置为在轴向上外径尺寸不断变化的弧形(如图6所示)等，保证第一大径段111的外径尺寸大于中间段120的外径尺寸即可。Please refer to FIG. 1 and FIG. 5 , in this embodiment, the first large-diameter section 111 is cylindrical, and the first large-diameter section 111 and themiddle section 120 are coaxially arranged, so the first large-diameter section 111 and the middle section are coaxial. The contour lines formed by the projection of 120 in the plane shown in FIG. 1 are parallel to each other. It should be noted that the shape of the first large-diameter section 111 is not limited here. It can be understood that in other embodiments, the shape of the first large-diameter section 111 can also be set as required. 111 is set in an arc shape (as shown in FIG. 6 ) whose outer diameter in the axial direction is constantly changing.

请参照图1，在本实施例中，中间段120的径向尺寸为R，14mm≤R≤24mm，可选地，中间段120的径向尺寸为14mm、19mm或24mm。第一大径段111的径向尺寸与第二大径段132的尺寸相等，同时第一大径段111和第二大径段132的径向尺寸的具体数值根据现有的中间段120与第一大径段111和第二大径段132的尺寸关系进行设置。Referring to FIG. 1 , in this embodiment, the radial dimension of themiddle section 120 is R, 14mm≤R≤24mm, optionally, the radial dimension of themiddle section 120 is 14mm, 19mm or 24mm. The radial dimension of the first large-diameter section 111 is equal to the size of the second large-diameter section 132, and the specific values of the radial dimensions of the first large-diameter section 111 and the second large-diameter section 132 are based on the existingintermediate section 120 and 132. The dimensional relationship between the firstlarge diameter section 111 and the secondlarge diameter section 132 is set.

在本实施例中，支架100整体进行覆膜，即组成支架100的第一大径段111、第一连接段112、中间段120、第二连接段131和第二大径段132均覆膜。具体的，该覆膜的具体操作方式可选地，通过将编织形成的金属架体浸入液态的硅胶中，待液态的硅胶将金属架体上的网格孔覆盖后，将金属架体取出，冷却后覆膜完成，从而将金属架体上的网格孔封闭，避免人体组织通过网格孔生长进入支架100内部。可以理解的，在其他实施例中，也可以根据需求仅将第一大径段111、第一连接段112、中间段120、第二连接段131和第二大径段132中的部分覆膜。In this embodiment, thestent 100 is covered as a whole, that is, the first large-diameter section 111 , the first connectingsection 112 , themiddle section 120 , the second connectingsection 131 and the second large-diameter section 132 constituting thestent 100 are all covered with film . Specifically, the specific operation mode of the film is optionally, by immersing the metal frame body formed by weaving in liquid silica gel, and after the liquid silica gel covers the mesh holes on the metal frame body, the metal frame body is taken out, After cooling, the film coating is completed, so that the mesh holes on the metal frame are closed to prevent human tissue from growing into the inside of thestent 100 through the mesh holes. It can be understood that, in other embodiments, only part of the first large-diameter section 111 , the first connectingsection 112 , themiddle section 120 , the second connectingsection 131 and the second large-diameter section 132 can be covered with film according to requirements. .

根据本实施例提供的一种支架100，支架100的工作原理：According to abracket 100 provided in this embodiment, the working principle of the bracket 100:

首先对支架100进行径向压缩，以将支架100的径向尺寸缩小，从而便于将支架100装入置入器200中，装入时，首先将支架100的近端装入容纳腔260内，在容纳腔260内，支架100与置入器200之间产生径向作用力，进而产生阻碍支架100继续向容纳腔260内进入的摩擦力，待中间段120装入容纳腔260中后，支架100受到的摩擦力由中间段120、第二连接段131和第二大径段132同时产生，此时支架100受到的摩擦力较大，由于第一连接段112沿远端到近端的方向外径逐渐减小，因此可有效降低第一连接段112处产生的摩擦力，进而保证支架100顺利装入置入器200中。First, thestent 100 is radially compressed to reduce the radial size of thestent 100, so that thestent 100 can be easily loaded into theimplanter 200. When loading, the proximal end of thestent 100 is first loaded into theaccommodating cavity 260, In theaccommodating cavity 260 , a radial force is generated between thestent 100 and theimplanter 200 , thereby generating a frictional force that prevents thestent 100 from continuing to enter theaccommodating cavity 260 . After themiddle section 120 is installed in theaccommodating cavity 260 , the stent will The frictional force received by thestent 100 is simultaneously generated by themiddle section 120, the second connectingsection 131 and the second large-diameter section 132. At this time, the frictional force received by thestent 100 is relatively large, because the first connectingsection 112 is in the direction from the distal end to the proximal end. The outer diameter gradually decreases, so the friction force generated at the first connectingsection 112 can be effectively reduced, thereby ensuring that thestent 100 is smoothly inserted into theimplanter 200 .

待支架100在置入器200的作用下置入人体的管腔中后，中间段120、第二连接段131以及第二大径段132形成的限位台阶140发挥防移位功能，避免支架100相对管腔移位，同时在支架100近端，即第二大径段132处，可以打夹子以辅助实现防移位功能，防移位效果更好。After thestent 100 is inserted into the lumen of the human body under the action of theimplanter 200, the limitingstep 140 formed by themiddle section 120, the second connectingsection 131 and the secondlarge diameter section 132 plays an anti-displacement function to prevent the stent from being displaced. 100 is displaced relative to the lumen, and at the same time at the proximal end of thestent 100, that is, at the secondlarge diameter section 132, a clip can be used to assist in realizing the anti-displacement function, and the anti-displacement effect is better.

本实施例提供的一种支架100至少具有以下优点：Thestent 100 provided in this embodiment has at least the following advantages:

本发明的实施例提供了一种支架100，该支架100通过将第一连接段112设置为沿远端到近端外径逐渐减小的结构，从而减小支架100装入置入器200时的摩擦阻力，有利于在不增大置入器200内径的情况下在置入器200中装入具有更大尺寸的支架100，从而使支架100具有更大的支持力以顺利将人体的管腔狭窄部位撑开，效果更好。同时，支架100的近端设置有限位台阶140，通过限位台阶140与人体组织的相互作用实现防止支架100移位的功能，防移位效果好，进而能够保证治疗效果，降低患者痛苦。通过对第一连接段112与中间段120形成的夹角α以及第二连接段131与中间段120形成的夹角β的具体设置，使得支架100兼顾了较好的防移位效果以及更加容易地装入置入器200的性能。The embodiment of the present invention provides astent 100. By setting the first connectingsegment 112 in a structure with a gradually decreasing outer diameter from the distal end to the proximal end, thestent 100 can reduce the time when thestent 100 is loaded into theimplanter 200. It is beneficial to install astent 100 with a larger size in theimplanter 200 without increasing the inner diameter of theimplanter 200, so that thestent 100 has a greater supporting force to smoothly connect the body's tube The narrowed part of the cavity is stretched, and the effect is better. At the same time, the proximal end of thestent 100 is provided with a limitingstep 140 , which can prevent thestent 100 from being displaced through the interaction between the limitingstep 140 and human tissue. Through the specific setting of the angle α formed by the first connectingsection 112 and themiddle section 120 and the angle β formed by the second connectingsection 131 and themiddle section 120, thebracket 100 has a better anti-displacement effect and is easier to performance of theimplanter 200.

请参照图2，本实施例也提供了一种置入系统10，置入系统10包括上述的支架100，同时置入系统10还包括置入器200，置入器200内具有容纳腔260，支架100安装在容纳腔260中，从而随置入器200经内镜钳道进入人体，随后通过操作置入器200释放支架100从而将支架100置入人体管腔中。Referring to FIG. 2, the present embodiment also provides animplantation system 10, theimplantation system 10 includes the above-mentionedbracket 100, and theimplantation system 10 further includes animplanter 200, and theimplanter 200 has aaccommodating cavity 260 therein. Thestent 100 is installed in theaccommodating cavity 260 to enter the human body through the endoscopic forceps with theimplanter 200 , and then thestent 100 is released by operating theimplanter 200 to place thestent 100 into the lumen of the human body.

图7为本实施例提供的置入系统10中置入器200的整体结构示意图，图8为本实施例提供的置入系统10中置入器200的局部结构示意图。请结合参照图2、图7和图8，在本实施例中，置入器200包括内管210、外管220和推动件230，外管220套设在内管210外，且外管220与内管210同轴间隔设置，从而在内管210和外管220之间形成间隙。内管210的远端设置为金属管部211，该金属管部211与外管220之间形成容纳腔260，即内管210用于与外管220形成容纳腔260的部分采用金属材质制成，通过设置金属管部211，从而在保证具有足够强度的同时可有效减小金属管部211的厚度，进而能够增大容纳腔260的空间尺寸，从而在不增大外管220内径的前提下为支架100提供更大的空间，以在容纳腔260内装入具有更大尺寸的支架100。FIG. 7 is a schematic diagram of the overall structure of theimplanter 200 in theimplantation system 10 provided in this embodiment, and FIG. 8 is a schematic diagram of a partial structure of theimplanter 200 in theimplantation system 10 provided by this embodiment. Please refer to FIG. 2 , FIG. 7 and FIG. 8 , in this embodiment, theimplanter 200 includes aninner tube 210 , anouter tube 220 and apusher 230 , theouter tube 220 is sleeved outside theinner tube 210 , and theouter tube 220 Coaxially spaced from theinner tube 210 , a gap is formed between theinner tube 210 and theouter tube 220 . The distal end of theinner tube 210 is set as ametal tube part 211 , and aaccommodating cavity 260 is formed between themetal tube part 211 and theouter tube 220 , that is, the part of theinner tube 210 used to form theaccommodating cavity 260 with theouter tube 220 is made of metal material , by arranging themetal tube portion 211, the thickness of themetal tube portion 211 can be effectively reduced while ensuring sufficient strength, thereby increasing the space size of theaccommodating cavity 260, so as not to increase the inner diameter of theouter tube 220 on the premise A larger space is provided for thestent 100 to accommodate thestent 100 having a larger size in theaccommodating cavity 260 .

可选地，内管210的材质为金属，金属管部211即为内管210远端对应形成容纳腔260的部分。具体的，内管210为不锈钢管。可以理解的，在其他实施例中，也可以根据需求具体设置金属管部211的材质，能够在保证强度的前提下减小金属管部211厚度，从而获得具有更大空间的容纳腔260即可。Optionally, the material of theinner tube 210 is metal, and themetal tube portion 211 is the portion of the distal end of theinner tube 210 corresponding to theaccommodating cavity 260 . Specifically, theinner tube 210 is a stainless steel tube. It can be understood that, in other embodiments, the material of themetal pipe portion 211 can also be specifically set according to the requirements, and the thickness of themetal pipe portion 211 can be reduced on the premise of ensuring the strength, so as to obtain aaccommodating cavity 260 with a larger space. .

需要说明的，在本实施例中，内管210整体为金属，金属管部211即为内管210远端对应形成容纳腔260的部分，可以理解的，在其他实施例中，也可以将内管210设置为由金属管与塑料管拼接形成的结构，例如仅将金属管部211设置为金属材质，内管210的其他部分采用塑料制成。It should be noted that, in this embodiment, theinner tube 210 is made of metal as a whole, and themetal tube portion 211 is the part of the distal end of theinner tube 210 corresponding to theaccommodating cavity 260 . It can be understood that in other embodiments, theinner tube 210 can also be Thetube 210 is set as a structure formed by splicing a metal tube and a plastic tube. For example, only themetal tube portion 211 is set to be made of metal, and the other parts of theinner tube 210 are made of plastic.

推动件230设置在内管210与外管220之间的间隙处，且与外管220可滑动地配合，使用时，通过推动件230推动支架100，以使支架100相对外管220运动，从而将容纳腔260开启，以实现支架100的释放(如图9所示)。Thepusher 230 is disposed at the gap between theinner tube 210 and theouter tube 220, and is slidably matched with theouter tube 220. When in use, thebracket 100 is pushed by thepusher 230 to move thebracket 100 relative to theouter tube 220, thereby Theaccommodating cavity 260 is opened to realize the release of the stent 100 (as shown in FIG. 9 ).

进一步地，在本实施例中，内管210包括相互连接的金属管部211和软管部，软管部位于内管210的近端，可以理解的，在其他实施例中，也可以根据需求，将内管210整体设置成由金属材质制成的管状件。具体地，金属管部211与软管部通过胶粘固定连接。Further, in this embodiment, theinner tube 210 includes ametal tube part 211 and a hose part which are connected to each other, and the hose part is located at the proximal end of theinner tube 210. It can be understood that in other embodiments, it can also be customized according to requirements. , theinner tube 210 is integrally arranged as a tubular member made of metal material. Specifically, themetal pipe part 211 and the hose part are fixedly connected by gluing.

请结合参照图7和图9，进一步地，置入器200包括设置在近端的第一操作手柄251和第二操作手柄252，第一操作手柄251位于第二操作手柄252的远端。内管210和推动件230连接在第二操作手柄252上，外管220连接在第一操作手柄251上，使用时，通过操纵第一操作手柄251和第二操作手柄252相对靠近，即可将内管210从外管220中推出，从而将容纳腔260打开，支架100在推动件230的作用下相对外管220运动，当容纳腔260打开时，外管220对支架100施加的径向阻挡力消失，从而使支架100在自身弹性作用下径向扩张，从而恢复原有径向尺寸，从而进行释放。Please refer to FIG. 7 and FIG. 9 , further, theinserter 200 includes afirst operating handle 251 and a second operating handle 252 disposed at the proximal end, and thefirst operating handle 251 is located at the distal end of thesecond operating handle 252 . Theinner tube 210 and thepusher 230 are connected to thesecond operation handle 252, and theouter tube 220 is connected to thefirst operation handle 251. When in use, thefirst operation handle 251 and the second operation handle 252 are relatively close to each other, and the Theinner tube 210 is pushed out from theouter tube 220, thereby opening theaccommodating cavity 260, and thestent 100 moves relative to theouter tube 220 under the action of thepusher 230. When theaccommodating cavity 260 is opened, theouter tube 220 acts as a radial block to thestent 100. The force disappears, so that thestent 100 radially expands under the action of its own elasticity, so as to restore the original radial size, thereby releasing.

图10为图9中Ⅹ处的局部结构放大图。请结合参照图2、图9和图10，进一步地，助推件包括中管231以及助推管232，中管231设置在内管210和外管220之间，且中管231为软管，从而便于置入器200在人体内的延伸，助推管232固定连接在第二操作手柄252上，且助推管232的远端与中管231的近端连接，通过助推管232推动中管231运动，进而推动支架100运动。可选地，中管231的近端包裹在助推管232的远端外部，从而实现中管231与助推管232的连接。可以理解的，在其他实施例中，也可以根据需求设置中管231与助推管232的连接方式，例如通过胶粘实现中管231与助推管232的连接。FIG. 10 is an enlarged view of a part of the structure at X in FIG. 9 . Please refer to FIG. 2 , FIG. 9 and FIG. 10 , further, the booster includes amiddle tube 231 and abooster tube 232 , themiddle tube 231 is arranged between theinner tube 210 and theouter tube 220 , and themiddle tube 231 is a hose , so as to facilitate the extension of theimplanter 200 in the human body, thebooster tube 232 is fixedly connected to thesecond operating handle 252, and the distal end of thebooster tube 232 is connected with the proximal end of themiddle tube 231, and is pushed through thebooster tube 232 Themiddle tube 231 moves, thereby pushing thebracket 100 to move. Optionally, the proximal end of themiddle tube 231 is wrapped outside the distal end of thebooster tube 232 , so as to realize the connection between themiddle tube 231 and thebooster tube 232 . It can be understood that, in other embodiments, the connection mode between themiddle tube 231 and thebooster tube 232 can also be set according to requirements, for example, the connection between themiddle tube 231 and thebooster tube 232 is realized by gluing.

进一步地，置入器200还包括锁紧螺母254以及锁扣253，第一操作手柄251的近端设置有用于容纳锁扣253的空腔，锁紧螺母254螺接在第一操作手柄251的近端，且助推管232穿过锁紧螺母254以及锁扣253设置，当锁紧螺母254拧紧时，锁扣253在锁紧螺母254的挤压下压缩，从而将助推管232锁紧，达到止推的效果；当锁紧螺母254松开时，锁扣253膨胀，从而将助推管232松开，助推管232能够在推动力的作用下相对外管220运动，从而推动支架100运动，以进行释放。Further, theimplanter 200 further includes alock nut 254 and alock catch 253 , a cavity for accommodating thelock catch 253 is provided at the proximal end of thefirst operating handle 251 , and thelock nut 254 is screwed on thefirst operating handle 251 . At the proximal end, thebooster tube 232 is disposed through thelock nut 254 and thelock catch 253. When thelock nut 254 is tightened, thelock catch 253 is compressed under the squeeze of thelock nut 254, thereby locking thebooster tube 232 , to achieve the thrust effect; when thelock nut 254 is loosened, thelock 253 expands, thereby loosening thebooster tube 232, and thebooster tube 232 can move relative to theouter tube 220 under the action of the pushing force, thereby pushing thebracket 100 movements to release.

请结合参照图7和图8，在本实施例中，置入器200还包括头部240，头部240上设置有相互连通的安装孔241和通孔242。金属管部211的远端安装在安装孔241内，且通孔242与内管210的内孔连通以形成用于供导丝270穿设的通道。通孔242的径向尺寸小于或者等于内孔的径向尺寸，因此金属管部211安装在安装孔241内后，金属管部211远端的端面完全抵接在安装孔241的孔底上，从而避免在置入器200沿导丝270向内运动的过程中，金属管部211的内孔与端面形成的尖角损伤导丝270。可选的，导丝270采用0.63mm导丝270，从而能够给置入器200腾出空间，以在置入器200中放入更强壮、尺寸更大的支架100。Please refer to FIG. 7 and FIG. 8 , in this embodiment, theimplanter 200 further includes ahead 240 , and thehead 240 is provided with aninstallation hole 241 and a throughhole 242 that communicate with each other. The distal end of themetal tube part 211 is installed in theinstallation hole 241 , and the throughhole 242 communicates with the inner hole of theinner tube 210 to form a channel for theguide wire 270 to pass through. The radial dimension of the throughhole 242 is smaller than or equal to the radial dimension of the inner hole, so after themetal pipe portion 211 is installed in theinstallation hole 241, the end face of the distal end of themetal pipe portion 211 completely abuts on the bottom of theinstallation hole 241, Therefore, during the inward movement of theinserter 200 along theguide wire 270 , the sharp angle formed by the inner hole and the end surface of themetal tube portion 211 may damage theguide wire 270 . Optionally, a 0.63mm guide wire 270 is used for theguide wire 270 to make room for theimplanter 200 to accommodate a stronger andlarger stent 100 in theimplanter 200 .

进一步地，头部240的材质为金属，通过将头部240设置为金属材质，从而在置入器200穿入人体的过程中，头部240的过狭窄能力强且显影能力强，从而能够更加清楚的观察到头部240的位置，有助于进行支架100的精确释放。可选地，头部240与金属管部211通过激光焊接固定，且头部240与金属管部211平滑连接，从而避免割伤导丝270外皮，有效降低了手术风险。Further, the material of thehead 240 is metal. By setting thehead 240 to be made of metal, thehead 240 has strong over-stenosis ability and strong developing ability during the process of inserting theinserter 200 into the human body, so that it can be more The position of thehead 240 is clearly observed, which facilitates the precise release of thestent 100 . Optionally, thehead 240 and themetal tube 211 are fixed by laser welding, and thehead 240 and themetal tube 211 are smoothly connected, so as to avoid cutting the outer skin of theguide wire 270 and effectively reduce the risk of surgery.

进一步地，头部240具有对应于通孔242的第一壁面243，同时，头部240还包括连接面245以及位于头部240外侧的第二壁面244，具体的，第二壁面244为头部240的外周面远端的部分。第一壁面243和第二壁面244通过连接面245连接，即连接面245的两端分别与第一壁面243和第二壁面244连接。连接面245为弧面，从而实现了第一壁面243和第二壁面244的圆滑过渡，避免损伤导丝270以及避免在穿入人体的过程中损伤人体，降低支架置入造成的损伤。Further, thehead portion 240 has afirst wall surface 243 corresponding to the throughhole 242 , and at the same time, thehead portion 240 further includes a connectingsurface 245 and asecond wall surface 244 located outside thehead portion 240 . Specifically, thesecond wall surface 244 is the head portion. The distal portion of the outer peripheral surface of 240. Thefirst wall surface 243 and thesecond wall surface 244 are connected by the connectingsurface 245 , that is, both ends of the connectingsurface 245 are connected with thefirst wall surface 243 and thesecond wall surface 244 respectively. The connectingsurface 245 is an arc surface, thereby realizing a smooth transition between thefirst wall surface 243 and thesecond wall surface 244, avoiding damage to theguide wire 270 and the human body during the process of penetrating the human body, and reducing the damage caused by stent placement.

进一步地，第二壁面244为圆弧面，即在如图8所示的剖面结构中，第二壁面244的截面轮廓为圆弧面。沿头部240的远端指向近端的方向，第二壁面244至头部240的轴线之间的距离逐渐增。Further, thesecond wall surface 244 is a circular arc surface, that is, in the cross-sectional structure shown in FIG. 8 , the cross-sectional contour of thesecond wall surface 244 is a circular arc surface. The distance from thesecond wall surface 244 to the axis of thehead 240 gradually increases in the direction in which the distal end of thehead 240 points toward the proximal end.

进一步地，头部240的近端具有抵接面246，抵接面246用于与外管220的远端抵接定位。进一步地，头部240还包括凸出抵接面246设置的卡块247，卡块247与抵接面246形成定位空间以容纳外管220的远端。具体的，卡块247为抵接面246沿远端到近端的方向凸出形成的环形凸起，外管220套设在该环形凸起上，且外管220远端的端面与抵接面246抵触时，实现外管220的轴向限位。Further, the proximal end of thehead 240 has anabutment surface 246 , and theabutment surface 246 is used for abutting and positioning with the distal end of theouter tube 220 . Further, thehead 240 further includes ablocking block 247 disposed protruding from the abuttingsurface 246 , and theblocking block 247 and theabutting surface 246 form a positioning space to accommodate the distal end of theouter tube 220 . Specifically, the blockingblock 247 is an annular protrusion formed by the abuttingsurface 246 protruding from the distal end to the proximal end. Theouter tube 220 is sleeved on the annular protrusion, and the end surface of the distal end of theouter tube 220 is in contact with the annular protrusion. When thesurfaces 246 collide, the axial limit of theouter tube 220 is achieved.

进一步地，置入器200上还设置有释放标识(图未示出)，通过释放标识也更加方便地确定支架100的释放位置，进而实现支架100的精确释放，降低置入系统10的操作难度，以及操作风险。具体地，在外观以及助推管232上分别设置有释放标识，释放标识通过激光雕刻加工产生，在内镜屏幕直视下可清楚观察外管220标识，从而进行支架100的精确释放。Further, theimplanter 200 is also provided with a release mark (not shown in the figure), and the release mark is also used to more conveniently determine the release position of thebracket 100, thereby realizing the precise release of thebracket 100 and reducing the difficulty of operation of theinsertion system 10. , and operational risk. Specifically, the appearance and thebooster tube 232 are respectively provided with release marks. The release marks are produced by laser engraving, and the marks of theouter tube 220 can be clearly observed under the direct view of the endoscope screen, so that thestent 100 can be accurately released.

根据本实施例提供的一种置入系统10，置入系统10的工作原理：According to animplantation system 10 provided in this embodiment, the working principle of the implantation system 10:

使用时，先将导丝270通过内镜钳道送入病灶部位，然后将装有支架100的置入器200的头部240穿过导丝270，导丝270通过头部240进入内管210的内孔中，并最终从第二操作手柄252穿出。选定支架100的释放位置后，在内窥镜直视下可以看到支架100释放的全过程，也可以在CT下观察显影的头部240来确定支架100的远端位置，保证支架100的精确释放。释放时，首先旋开锁紧螺母254，使锁紧螺母254与第一操作手柄251分离，此时锁扣253膨胀以将包裹住的助推管232释放，助推管232解锁，然后一手握紧第一操作手柄251，一手握紧第二操作手柄252并缓慢推送，从而通过中管231的远端将置入器200中的支架100推出，支架100缓慢释放。In use, theguide wire 270 is first sent into the lesion through the endoscopic forceps, and then thehead 240 of theimplanter 200 with thestent 100 is passed through theguide wire 270, and theguide wire 270 enters theinner tube 210 through thehead 240 into the inner hole, and finally pass through thesecond operating handle 252 . After selecting the release position of thestent 100, the whole process of releasing thestent 100 can be seen under the direct vision of the endoscope, and the developedhead 240 can also be observed under the CT to determine the distal position of thestent 100, so as to ensure the safety of thestent 100. Precise release. When releasing, first unscrew thelock nut 254 to separate thelock nut 254 from thefirst operating handle 251, at this time thelock 253 expands to release theenclosed booster tube 232, thebooster tube 232 is unlocked, and then hold with one hand Tighten thefirst operating handle 251, hold the second operating handle 252 with one hand and push it slowly, so that thestent 100 in theimplanter 200 is pushed out through the distal end of themiddle tube 231, and thestent 100 is slowly released.

本实施例提供的一种置入系统10至少具有以下优点：Theimplantation system 10 provided by this embodiment has at least the following advantages:

本发明的实施例提供的置入系统10包括上述的支架100，因此也具有能够在不增大置入器200内径的情况下在置入器200中装入具有更大尺寸的支架100，从而使支架100具有更大的支持力以顺利将人体的管腔狭窄部位撑开，支撑效果更好，而且防移位效果好的有益效果。同时置入系统10的置入器200通过在内管210设置金属管部211，使得在保证强度的前提下减小金属管部211厚度，从而获得具有更大空间的容纳腔260，进而能够在容纳腔260中装入具有较大尺寸的支架100，进而有效保证支架100具有足够的支撑力。Theimplantation system 10 provided by the embodiment of the present invention includes thestent 100 described above, and therefore also has astent 100 with a larger size that can be installed in theimplanter 200 without increasing the inner diameter of theimplanter 200 , thereby Thestent 100 has a greater supporting force so that the narrow part of the lumen of the human body can be stretched smoothly, the supporting effect is better, and the anti-displacement effect is good. At the same time, theimplanter 200 of thesystem 10 is placed in theinner tube 210 by disposing themetal tube portion 211, so that the thickness of themetal tube portion 211 is reduced on the premise of ensuring the strength, so as to obtain aaccommodating cavity 260 with a larger space, which can be used in Abracket 100 with a larger size is installed in theaccommodating cavity 260 , thereby effectively ensuring that thebracket 100 has sufficient supporting force.

以上所述，仅为本发明的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到的变化或替换，都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应以所述权利要求的保护范围为准。The above are only specific embodiments of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art who is familiar with the technical scope disclosed by the present invention can easily think of changes or substitutions. All should be included within the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.