CN112022436A

Movatterモバイル変換

Info

Publication number: CN112022436A
Application number: CN202011092050.9A
Authority: CN
Inventors: 张玮
Original assignee: Hangzhou Weiqiang Medical Technology Co Ltd
Current assignee: Hangzhou Endonom Medtech Co Ltd
Priority date: 2020-10-13
Filing date: 2020-10-13
Publication date: 2020-12-04
Anticipated expiration: 2040-10-13
Also published as: CN112022436B

Abstract

Translated fromChinese

本发明提供了一种覆膜支架，包括支架主体、外分支及至少一个内分支；支架主体为表面设有覆膜的管状结构，其上形成有径向凹陷的凹部；外分支悬伸于所述支架主体外部，其一端连接于所述凹部的侧壁，并在该凹部的侧壁上具有内开口；内分支贴合固定于所述支架主体的内壁，每一内分支的一端连接于该凹部的侧壁，并在该凹部的侧壁上具有外开口；所述外开口相比于所述内开口更靠近远端。本发明的覆膜支架无需定制、适用范围广、手术操作简单。

The invention provides a covered stent, comprising a stent main body, an outer branch and at least one inner branch; the stent main body is a tubular structure with a covering film on the surface, and a radially concave concave portion is formed thereon; The outside of the bracket body, one end of which is connected to the side wall of the recess, and has an inner opening on the side wall of the recess; the inner branches are attached and fixed to the inner wall of the bracket body, and one end of each inner branch is connected to the The side wall of the concave portion has an outer opening on the side wall of the concave portion; the outer opening is closer to the distal end than the inner opening. The stent-graft of the present invention does not require customization, has a wide range of applications, and is simple to operate.

Description

Translated fromChinese

覆膜支架stent graft

技术领域technical field

本发明涉及医疗器械技术领域，特别涉及一种覆膜支架。The invention relates to the technical field of medical devices, in particular to a covered stent.

背景技术Background technique

主动脉瘤是指主动脉壁局部或弥漫性的异常扩张。主动脉瘤会压迫周围器官而引起症状，瘤状破裂为其主要危险。主动脉瘤常发生在升主动脉主动脉弓、胸部降主动脉、胸腹主动脉和腹主动脉。主动脉瘤按结构可分为真性主动脉瘤、假性主动脉瘤和夹层主动脉瘤。Aortic aneurysm is a localized or diffuse abnormal expansion of the aortic wall. Aortic aneurysms can compress surrounding organs and cause symptoms, and aneurysmal rupture is the main risk. Aortic aneurysms often occur in the ascending aortic arch, descending thoracic aorta, thoracoabdominal aorta, and abdominal aorta. Aortic aneurysms can be divided into true aortic aneurysms, pseudo-aortic aneurysms and dissecting aortic aneurysms according to their structure.

主动脉瘤会引起血管内侧压增高，故呈进行性膨大，若长期发展，最后终归破裂，瘤体越大，破裂的可能性越大。栓塞为另一并发症。据统计，若不作手术治疗，90％胸主动脉瘤患者在5年内死亡，75％腹主动脉瘤患者在5年内死亡。Aortic aneurysm can cause increased pressure inside the blood vessel, so it is progressively enlarged. If it develops for a long time, it will eventually rupture. Embolism is another complication. According to statistics, without surgical treatment, 90% of patients with thoracic aortic aneurysm will die within 5 years, and 75% of patients with abdominal aortic aneurysm will die within 5 years.

夹层主动脉瘤是由于主动脉内膜局部破损，高压血流冲入血管壁，造成中膜撕裂(中层的裂开通常是在中层内1/3和外2/3交界面)，使完整的主动脉壁结构一分为二，在夹层的内、外壁间的裂开间隙中形成一个夹层腔。为了与主动脉腔区别，夹层腔称为假腔，主动脉腔称为真腔。Dissecting aortic aneurysm is due to local damage of the aortic intima, high-pressure blood flow into the vessel wall, resulting in a tear in the media (the dehiscence of the media is usually at the interface between the inner 1/3 and outer 2/3) The structure of the aortic wall is divided into two, forming a dissection cavity in the dehiscence gap between the inner and outer walls of the dissection. To distinguish it from the aortic lumen, the dissection lumen is called the false lumen, and the aortic lumen is called the true lumen.

主动脉疾病均有可能涉及到分支动脉，一旦涉及到分支动脉想通过介入方法解决就会举步维艰。目前国内外已开展了动脉腔内治疗术，即采用微创方法，借助血管腔道向病变动脉内置入移植物即动脉覆膜支架来治疗动脉疾病改善供血，从而达到治疗目的。使用时将动脉覆膜支架轴向压缩后装载于输送器中，由输送器通过较小的股动脉、髂动脉、肱动脉送到病变动脉处再将其释放，由于动脉覆膜支架的弹力作用自动恢复成直管状并紧贴于主动脉内壁，将动脉病变部位与血流隔离，从而达到了治疗目的。Aortic disease may involve branch arteries, and once the branch arteries are involved, it will be difficult to solve by interventional methods. At present, intraluminal arterial therapy has been carried out at home and abroad, that is, a minimally invasive method is used, and a graft, namely an arterial stent-graft, is inserted into the diseased artery with the help of the vascular lumen to treat arterial disease and improve blood supply, so as to achieve the purpose of treatment. When in use, the stent-graft is axially compressed and then loaded into the conveyor, which is sent to the diseased artery through the smaller femoral artery, iliac artery, and brachial artery and then released, due to the elastic effect of the stent-graft. It automatically restores to a straight tube shape and sticks to the inner wall of the aorta, isolating the diseased part of the artery from the blood flow, so as to achieve the purpose of treatment.

受到目前支架结构的限制，现有产品涉及动脉分支的治疗均有不可避免的问题，造成治疗时或治疗后发生并发症的隐患，具体分析如下：Due to the limitation of the current stent structure, the existing products have unavoidable problems in the treatment of arterial branches, resulting in hidden dangers of complications during or after treatment. The specific analysis is as follows:

1、烟囱支架1. Chimney bracket

“烟囱”技术又称为平行支架技术，是指在被封堵的分支血管内置入支架，与主动脉内的主体支架并行释放，从而达到保留弓部分支的目的。根据支架的位置可分为锁骨下动脉“烟囱”、颈动脉“烟囱”和头臂干动脉“烟囱”；根据支架的数量可以分为“单烟囱”、“双烟囱”和“三烟囱”。“烟囱支架”技术的优点是：所应用的手术器材均为常规器材，临床上容易获得；技术难度相对较低；在选择合适的病例中，内漏发生率低，封堵效果良好。其缺点是：在小支架和主动脉主体支架间存在“沟槽”，并不是完美的封堵术，存在内漏的风险；另一方面，主动脉主体支架与小支架并行释放，主体支架可能会压迫小支架，造成小支架血流不畅，甚至堵塞的情况。The "chimney" technique, also known as the parallel stent technique, refers to inserting a stent into the blocked branch vessel and releasing it in parallel with the main stent in the aorta, so as to achieve the purpose of retaining the arcuate branch. According to the position of the stent, it can be divided into subclavian artery "chimney", carotid artery "chimney" and brachiocephalic artery "chimney"; according to the number of stents, it can be divided into "single chimney", "double chimney" and "three chimneys". The advantages of the "chimney stent" technique are: the applied surgical equipment is all conventional equipment, which is easy to obtain clinically; the technical difficulty is relatively low; in the selection of suitable cases, the incidence of endoleak is low, and the sealing effect is good. The disadvantage is: there is a "groove" between the small stent and the main aortic stent, which is not a perfect occlusion technique, and there is a risk of endoleak; on the other hand, the main aortic stent and the small stent are released in parallel, and the main stent may be It will compress the small stent, resulting in poor blood flow or even blockage of the small stent.

2、开窗型支架2. Window bracket

现有的“开窗支架”主要包括术中原位开窗和订制开窗。其中原位开窗是先放置主动脉主体支架覆盖病变和预开窗血管，然后在预开窗的分支血管内导入开窗器械(如硬头导丝、激光、射频等)，刺破主动脉支架，再辅助球囊和支架来开通分支血管，原位开窗手术操作复杂，对医生的手术水平有一定的要求，另外植入后的支架的耐久性，远期的抗疲劳性能不佳，并且容易出现内漏。预开窗支架是由支架生产厂家个体化的制作完成，通过术前的影像学检查结果，制作出符合不同病人主动脉弓解剖形态的支架，因此，这一类支架具有较好的支撑力、贴附性、定位能力，但是定制支架需要一定的时间周期，不适合急诊病例，此外支架的制作需要考虑到主动脉弓的曲度，弓上大血管分支开口的相对位置，病变的位置，窗口的标记，支架定位等技术细节。The existing "fenestration bracket" mainly includes intraoperative in-situ fenestration and customized fenestration. The in situ fenestration is to first place the main aortic stent to cover the lesions and pre-fenestrated blood vessels, and then introduce fenestration devices (such as hard-tipped guide wires, lasers, radio frequency, etc.) into the pre-fenestrated branch blood vessels to puncture the aorta. Stents, and then assist balloons and stents to open branch blood vessels, in situ fenestration surgery is complicated, and has certain requirements for doctors’ surgical skills. In addition, the durability of implanted stents and long-term anti-fatigue performance are not good. and prone to internal leakage. Pre-fenestration stents are individually manufactured by stent manufacturers. Through preoperative imaging examination results, stents that conform to the anatomy of the aortic arch of different patients are manufactured. Therefore, this type of stent has better supporting force and adhesion. However, custom-made stents require a certain period of time and are not suitable for emergency cases. In addition, the manufacture of stents needs to take into account the curvature of the aortic arch, the relative position of the branch openings of the great vessels on the arch, the position of the lesion, the marking of the window, and the stent. Positioning and other technical details.

3、一体式分支支架3. One-piece branch bracket

一体式分支支架可以避免因烟囱支架植入所带来的“沟槽”，可以避免开窗对位不良导致的内漏等问题，其贴附性更好，发生内漏的几率更少。但是受到分支支架输送、导入、定位、释放等多个技术问题的影响，至今仍没有一种成熟适用的支架产品投放市场。The integrated branch stent can avoid the "groove" caused by the implantation of the chimney stent, and can avoid problems such as endoleak caused by poor alignment of the window. It has better adhesion and less chance of endoleak. However, affected by many technical problems such as branch stent delivery, introduction, positioning, and release, there is still no mature and applicable stent product on the market.

因此，有必要开发一种更适合主动脉弓部分支重建的介入治疗支架系统。Therefore, it is necessary to develop an interventional stent system that is more suitable for aortic arch branch reconstruction.

发明内容SUMMARY OF THE INVENTION

本发明的目的在于提供一种无需定制、适用范围广、手术操作简单的覆膜支架。The purpose of the present invention is to provide a stent-graft that does not require customization, has a wide range of applications, and is simple to operate.

为解决上述技术问题，本发明采用如下技术方案：一种覆膜支架，包括支架主体、外分支及至少一个内分支；支架主体为表面设有覆膜的管状结构，其上形成有径向凹陷的凹部；外分支悬伸于所述支架主体外部，其一端连接于所述凹部的侧壁，并在该凹部的侧壁上具有内开口；内分支贴合固定于所述支架主体的内壁，每一内分支的一端连接于该凹部的侧壁，并在该凹部的侧壁上具有外开口；所述外开口相比于所述内开口更靠近远端。In order to solve the above technical problems, the present invention adopts the following technical solutions: a covered stent, comprising a stent main body, an outer branch and at least one inner branch; the stent main body is a tubular structure with a film covering on the surface, and radial depressions are formed on it. The outer branch is suspended from the outside of the bracket body, one end of which is connected to the side wall of the recess, and has an inner opening on the side wall of the recess; the inner branch is attached and fixed to the inner wall of the bracket body, One end of each inner branch is connected to the side wall of the recess, and has an outer opening on the side wall of the recess; the outer opening is closer to the distal end than the inner opening.

在一些实施例中，所述内分支数量为两个，分别为第一内分支和第二内分支；所述第一内分支在所述凹部的侧壁上具有第一外开口，所述第二内分支在所述凹部的侧壁上具有第二外开口，所述第二外开口相比于所述第一外开口更靠近远端。In some embodiments, the number of the inner branches is two, which are a first inner branch and a second inner branch respectively; the first inner branch has a first outer opening on the side wall of the recess, and the first inner branch has a first outer opening. The two inner branches have a second outer opening on the side wall of the recess, and the second outer opening is closer to the distal end than the first outer opening.

在一些实施例中，所述第一内分支从所述第一外开口处向近端方向延伸。In some embodiments, the first inner branch extends proximally from the first outer opening.

在一些实施例中，所述第二内分支从所述第二外开口处向远端方向延伸。In some embodiments, the second inner branch extends distally from the second outer opening.

在一些实施例中，随着向所述远端方向的延伸，所述第二内分支还从所述第二外开口处沿着所述支架主体周向延伸。In some embodiments, the second inner branch further extends circumferentially along the stent body from the second outer opening as it extends in the distal direction.

在一些实施例中，随着向所述近端方向的延伸，所述第一内分支还从所述第一外开口处沿着所述支架主体周向延伸。In some embodiments, the first inner branch further extends circumferentially along the stent body from the first outer opening as it extends in the proximal direction.

在一些实施例中，所述第二内分支从所述第二外开口处向近端方向延伸，且随着向所述近端方向的延伸，所述第二内分支还从所述第二外开口处沿着所述支架主体周向延伸；所述第二内分支沿周向延伸的方向与所述第一内分支沿周向延伸的方向相背离。In some embodiments, the second inner branch extends proximally from the second outer opening, and along with extending toward the proximal direction, the second inner branch also extends from the second outer opening in a proximal direction. The outer opening extends along the circumferential direction of the bracket body; the circumferentially extending direction of the second inner branch deviates from the circumferentially extending direction of the first inner branch.

在一些实施例中，所述外分支的长度为5mm～20mm。In some embodiments, the length of the outer branch is 5mm˜20mm.

在一些实施例中，所述外分支具有可柔性变形的柔性段，所述柔性段从所述内开口处向外延伸。In some embodiments, the outer branch has a flexibly deformable flexible segment extending outwardly from the inner opening.

在一些实施例中，所述柔性段由柔性薄膜材料构成。In some embodiments, the flexible segment is constructed of a flexible film material.

在一些实施例中，所述过渡段长度为2mm～10mm，且不超过所述外分支总长度的1/2。In some embodiments, the length of the transition section is 2 mm˜10 mm, and does not exceed 1/2 of the total length of the outer branch.

在一些实施例中，所述外分支和所述内分支上分别设有显影件，所述显影件由不透射材料制成。In some embodiments, developing members are respectively provided on the outer branch and the inner branch, and the developing members are made of opaque material.

在一些实施例中，所述内开口或所述外开口处沿周向设置所述显影件。In some embodiments, the developing member is disposed in the circumferential direction at the inner opening or the outer opening.

在一些实施例中，所述外分支或所述内分支上分别沿各自延伸方向设置所述显影件。In some embodiments, the developing members are respectively disposed on the outer branch or the inner branch along their respective extending directions.

在一些实施例中，所述显影件通过热压或缝合而固定。In some embodiments, the developing member is fixed by heat pressing or sewing.

在一些实施例中，所述支架主体包括由近端至远端依次设置的近端管体、中间管体和远端管体；所述中间管体的直径小于所述近端管体和所述远端管体的直径，所述中间管体处构成所述凹部。In some embodiments, the stent body includes a proximal tube body, a middle tube body and a distal tube body arranged in sequence from the proximal end to the distal end; the diameter of the middle tube body is smaller than that of the proximal tube body and all the The diameter of the distal tube body, and the recessed portion is formed at the middle tube body.

在一些实施例中，所述中间管体的两端各通过一过渡管体与所述近端管体、所述远端管体相连接；所述过渡管体具有用于支撑覆膜的呈圆台状的过渡支撑架，所述过渡支撑架的小端面向所述中间管体。In some embodiments, both ends of the intermediate pipe body are connected to the proximal pipe body and the distal pipe body through a transition pipe body; A frustum-shaped transition support frame, the small end of the transition support frame faces the intermediate pipe body.

在一些实施例中，所述近端管体上设有后释放部件；所述后释放部件为径向可收缩的环状结构，固定于所述覆膜上，并在朝近端方向突伸出所述覆膜的近端边缘。In some embodiments, the proximal tube body is provided with a rear release member; the rear release member is a radially retractable annular structure, fixed on the membrane, and protrudes in the proximal direction out the proximal edge of the membrane.

在一些实施例中，所述后释放部件上沿周向突出设置有倒刺。In some embodiments, the rear release member is provided with barbs protruding in the circumferential direction.

在一些实施例中，所述覆膜的端部设有显影标记，所述显影标记由不透射材料制成。In some embodiments, the ends of the film are provided with developing markings, the developing markings being made of an opaque material.

由上述技术方案可知，本发明至少具有如下优点和积极效果：As can be seen from the above technical solutions, the present invention at least has the following advantages and positive effects:

本发明的覆膜支架中，在支架主体上一体形成有外分支和至少一个内分支，这些分支可以分别向外接的分支支架对应提供定位以及支撑功能，并且，这些分支位于支架主体的凹部，基于该凹部的径向凹陷使其与血管壁之间形成一定的间隙，能够在腔内治疗时给予导丝和导管足够的操作空间，便于在手术过程中将外接的分支支架快速送入分支血管内。同时，由于凹部在沿径向凹陷的，在各分支支架植入血管后，覆膜支架也不会挤压到分支血管造成分支血管堵塞。各分支支架分别对应利用外分支和内分支与覆膜支架锚定，手术操作更为简单，缩短手术过程。In the stent-graft of the present invention, an outer branch and at least one inner branch are integrally formed on the stent main body, and these branches can respectively provide positioning and supporting functions to the external branch stent, and these branches are located in the concave portion of the stent main body, based on The radial depression of the concave part forms a certain gap between the concave part and the blood vessel wall, which can give the guide wire and the catheter enough operating space during the endoluminal treatment, so as to facilitate the rapid delivery of the external branch stent into the branch blood vessel during the operation. . At the same time, since the concave portion is concave in the radial direction, after each branch stent is implanted into the blood vessel, the stent-graft will not squeeze the branch blood vessel to cause blockage of the branch blood vessel. Each branch stent is respectively anchored with the outer branch and the inner branch and the covered stent, so that the operation is simpler and the operation process is shortened.

特别地，覆膜支架的这多个分支中，最近端的分支为悬伸于支架主体外部的外分支，在覆膜支架送入主动脉血管的预定位置时，外分支可以伸入分支动脉血管例如无名动脉中，从而便于确定覆膜支架是否输送到位；同时在外分支释放后，基于外分支与分支动脉血管的配合，配合支架主体与主动脉血管的配合，使得覆膜支架整体不易移位，方便后续分支支架的植入。位于外分支更远端的内分支位于支架主体的内部，内分支不超出支架主体，而是仅在支架主体的侧壁暴露出外开口，配合凹部所提供的操作空间，使得分支支架经内分支向分支动脉血管植入时可以有更大的位置调整空间，更方便地植入分支动脉血管，内分支无需准确地与分支动脉血管的入口相对，因而覆膜支架具有更广的适用性和更高的通用性。In particular, among the multiple branches of the stent-graft, the most proximal branch is an outer branch that is overhanging the outside of the stent body. When the stent-graft is delivered to a predetermined position of the aortic vessel, the outer branch can extend into the branch artery, such as In the innominate artery, it is convenient to determine whether the stent-graft is delivered in place; at the same time, after the outer branch is released, based on the cooperation between the outer branch and the branch artery, and the cooperation between the stent body and the aorta, the overall stent-graft is not easy to displace, which is convenient Subsequent branch stent implantation. The inner branch located at the farther end of the outer branch is located inside the stent body, the inner branch does not extend beyond the stent body, but only exposes the outer opening on the side wall of the stent body, and cooperates with the operating space provided by the recess, so that the branch stent passes through the inner branch to the stent body. When the branch artery is implanted, there can be a larger space for position adjustment, and the branch artery can be implanted more conveniently. The inner branch does not need to be exactly opposite to the entrance of the branch artery, so the stent graft has wider applicability and higher generality.

采用本发明的覆膜支架，使得主动脉支架和外接分支动脉支架为分别独立的结构，适用于各种正常及走形变异的血管，可以根据病变的具体情况，分别选择合适尺寸的主动脉支架血管和分支动脉支架血管，组合成一套最适合患者的支架血管系统，避免定制支架，可以批量生产，并有效节省时间与操作容易的功效。Using the covered stent of the present invention, the aortic stent and the external branch artery stent are independent structures, which are suitable for various normal and deformed blood vessels, and aortic stents of appropriate size can be selected according to the specific conditions of the lesions. Blood vessels and branch artery stents are combined into a set of stent vascular systems that are most suitable for patients, avoiding custom stents, mass production, and effective time saving and easy operation.

附图说明Description of drawings

图1是本发明覆膜支架第一实施例的结构示意图。FIG. 1 is a schematic structural diagram of the first embodiment of the stent graft of the present invention.

图2是图1的另一个视角方向的示意图。FIG. 2 is a schematic diagram of another viewing angle of FIG. 1 .

图3是图2中A处局部放大图。FIG. 3 is a partial enlarged view of part A in FIG. 2 .

图4是图1的使用状态图。FIG. 4 is a use state diagram of FIG. 1 .

图5是本发明覆膜支架第二实施例的结构示意图。FIG. 5 is a schematic structural diagram of the second embodiment of the stent graft of the present invention.

图6是本发明覆膜支架第三实施例的结构示意图。6 is a schematic structural diagram of a third embodiment of the stent graft of the present invention.

图7是本发明覆膜支架第四实施例的结构示意图。7 is a schematic structural diagram of a fourth embodiment of the stent graft of the present invention.

图8是本发明覆膜支架第五实施例的结构示意图。8 is a schematic structural diagram of a fifth embodiment of the stent graft of the present invention.

图9是本发明覆膜支架第六实施例的结构示意图。FIG. 9 is a schematic structural diagram of a sixth embodiment of the stent graft of the present invention.

图10是本发明覆膜支架第七实施例的结构示意图。10 is a schematic structural diagram of a seventh embodiment of the stent graft of the present invention.

附图标记说明如下：The reference numerals are explained as follows:

100/100a/100b/100c/100d/100e/100f、覆膜支架；200、第一分支支架；300、第二分支支架；400、第三分支支架；600、主动脉；601、升主动脉；602、主动脉弓；603、降主动脉；700、无名动脉；800、左颈总动脉；900、左锁骨下动脉；100/100a/100b/100c/100d/100e/100f, stent graft; 200, first branch stent; 300, second branch stent; 400, third branch stent; 600, aorta; 601, ascending aorta; 602, aortic arch; 603, descending aorta; 700, innominate artery; 800, left common carotid artery; 900, left subclavian artery;

1/1a/1c/1d/1e/1f、支架主体；101、支撑架；102/102c、覆膜；103、凹部；104、过渡支撑架；105、后释放部件；106、显影标记；11、近端管体；12、中间管体；13、远端管体；14、第一过渡管体；15、第二过渡管体；1/1a/1c/1d/1e/1f, stent body; 101, support frame; 102/102c, film; 103, recess; 104, transition support frame; 105, rear release part; 106, development mark; 11, Proximal tube body; 12. Intermediate tube body; 13. Distal tube body; 14. First transition tube body; 15. Second transition tube body;

2/2a/2c/2d/2e/2f、外分支；21/21a/21f、内开口；22/22e/22f、薄膜；221f、柔性段；23/23e/23f、支撑圈；24、显影件；2/2a/2c/2d/2e/2f, outer branch; 21/21a/21f, inner opening; 22/22e/22f, film; 221f, flexible segment; 23/23e/23f, support ring; 24, developing piece ;

3/3a/3b/3c/3d/3e/3f、第一内分支；31/31a/31c/31d、第一外开口；32/32b、显影件；3/3a/3b/3c/3d/3e/3f, the first inner branch; 31/31a/31c/31d, the first outer opening; 32/32b, the developing part;

4/4a/4b/4c/4d/4e/4f、第二内分支；41/41c/41d、第二外开口；42/42b、显影件。4/4a/4b/4c/4d/4e/4f, the second inner branch; 41/41c/41d, the second outer opening; 42/42b, the developing piece.

具体实施方式Detailed ways

体现本发明特征与优点的典型实施方式将在以下的说明中详细叙述。应理解的是本发明能够在不同的实施方式上具有各种的变化，其皆不脱离本发明的范围，且其中的说明及图示在本质上是当作说明之用，而非用以限制本发明。Exemplary embodiments embodying the features and advantages of the present invention will be described in detail in the following description. It should be understood that the present invention can have various changes in different embodiments without departing from the scope of the present invention, and the descriptions and drawings therein are essentially used for illustration rather than limitation this invention.

本发明提供一种覆膜支架，可用于主动脉血管病变介入治疗。基于该覆膜支架，可以重建主动脉以及主动脉弓部三个主要分支动脉血流通道。The invention provides a covered stent, which can be used for interventional treatment of aortic vascular disease. Based on the stent-graft, the blood flow channels of the aorta and the three main branches of the aortic arch can be reconstructed.

为便于表述，本文中定义“近端”是指沿血流方向靠近心脏的一端，“远端”是指远离心脏的一端。其中，动脉内血流方向是由近端向远端的方向流动。For ease of expression, "proximal" is defined herein as the end close to the heart in the direction of blood flow, and "distal" is defined as the end away from the heart. Among them, the direction of blood flow in the artery is from the proximal to the distal direction.

第一实施例，请参阅图1至图4所示的结构及使用状态。For the first embodiment, please refer to the structures and usage states shown in FIG. 1 to FIG. 4 .

首先参阅图1和图2，本实施例的覆膜支架100主要包括支架主体1以及与支架主体1连为一体的一个外分支2和两个内分支3、4。其中，外分支2位于支架主体1外部，两个内分支3、4均位于支架主体1内部，外分支2和两个内分支3、4由近端至远端依次排布，分别与支架主体1连接固定。为便于表述，将两个内分支3、4分为更靠近近端的第一内分支3和更靠近远端的第二内分支4。Referring first to FIG. 1 and FIG. 2 , the stent-graft 100 of this embodiment mainly includes a stent body 1 , anouter branch 2 and twoinner branches 3 and 4 integrally connected with the stent body 1 . Theouter branch 2 is located outside the stent body 1, the twoinner branches 3 and 4 are both located inside the stent body 1, and theouter branch 2 and the twoinner branches 3 and 4 are sequentially arranged from the proximal end to the distal end, and are respectively connected with the stent body. 1 The connection is fixed. For ease of expression, the twoinner branches 3, 4 are divided into a firstinner branch 3 closer to the proximal end and a second inner branch 4 closer to the distal end.

主要参阅图1，支架主体1为表面设有覆膜102的管状结构，其骨架主要由沿轴向排布的多个环形的支撑架101构成。支撑架101由具有弹性的刚性丝形成环形，在径向上可以收缩或展开。Referring mainly to FIG. 1 , the stent main body 1 is a tubular structure with acoating 102 on the surface, and its skeleton is mainly composed of a plurality of annular support frames 101 arranged along the axial direction. Thesupport frame 101 is formed into an annular shape by elastic rigid wires, which can be contracted or expanded in the radial direction.

支撑架101可由形状记忆合金材料制成，优选镍钛合金材料。覆膜102可由任何合适的覆膜材料形成，包括但不限于：低孔隙度织造或针织聚酯、涤纶材料、膨胀型聚四氟乙烯、聚氨酯、硅酮、超高分子量聚乙烯或其他合适材料。Thesupport frame 101 may be made of a shape memory alloy material, preferably a Nitinol material.Laminate 102 may be formed from any suitable lamination material including, but not limited to, low porosity woven or knitted polyester, dacron material, expanded polytetrafluoroethylene, polyurethane, silicone, ultra-high molecular weight polyethylene, or other suitable materials .

各支撑架101通过缝合或热压的方式固定在覆膜102的内表面或外表面，通过该多个支撑架101来支撑覆膜102，以使支架主体1在使用时能够展开并保持为管状结构，从而得以构建供血液通过的通道。Eachsupport frame 101 is fixed on the inner surface or the outer surface of thefilm 102 by sewing or heat pressing, and thefilm 102 is supported by the plurality of support frames 101, so that the stent body 1 can be expanded and maintained in a tubular shape during use structure, so as to build a channel for blood to pass through.

沿支架主体1的轴向由近端至远端的方向上，支架主体1依次具有近端管体11、第一过渡管体14、中间管体12、第二过渡管体15和远端管体13。Along the axial direction of the stent body 1 from the proximal end to the distal end, the stent body 1 sequentially has a proximalend tube body 11 , a firsttransition tube body 14 , anintermediate tube body 12 , a secondtransition tube body 15 and a distalend tube body 12 .body 13.

其中，近端管体11、中间管体12及远端管体13各自均为基本等径的管状结构。中间管体12的直径D12小于近端管体11的直径D11和远端管体13的直径D13，由此，从支架主体1整体上来看，在中间管体12处形成径向凹陷的凹部103。Wherein, theproximal tube body 11 , theintermediate tube body 12 and thedistal tube body 13 are respectively tubular structures with substantially equal diameters. The diameter D12 of themiddle tube body 12 is smaller than the diameter D11 of theproximal tube body 11 and the diameter D13 of thedistal tube body 13 , so that, from the overall perspective of the stent body 1 , a radiallyconcave recess 103 is formed at themiddle tube body 12 .

作为示例，中间管体12的直径D12大致地可以是近端管体11的直径D11的70％～80％，大致是远端管体13的直径D13的75％～95％。可以理解的是，近端管体11的直径D11与远端管体13的直径D13可以是相同的，也可以是不同的。As an example, the diameter D12 of theintermediate tube body 12 may be approximately 70%-80% of the diameter D11 of theproximal tube body 11 and approximately 75%-95% of the diameter D13 of thedistal tube body 13 . It can be understood that the diameter D11 of theproximal tube body 11 and the diameter D13 of thedistal tube body 13 may be the same or different.

第一过渡管体14和第二过渡管体15则均呈圆台状，即均为渐变直径的管状结构。第一过渡管体14的近端与近端管体11相连接，第一过渡管体14的远端与中间管体12相连接，相应地，第一过渡管体14的近端直径大于其远端直径。第二过渡管体15的近端与中间管体12相连接，第二过渡管体15的远端与远端管体13相连接，相应地，第二过渡管体15的近端直径小于其远端直径。The firsttransition pipe body 14 and the secondtransition pipe body 15 are both in the shape of a truncated cone, that is, they are both tubular structures with a gradual diameter. The proximal end of the firsttransition pipe body 14 is connected with theproximal pipe body 11, and the distal end of the firsttransition pipe body 14 is connected with theintermediate pipe body 12. Correspondingly, the diameter of the proximal end of the firsttransition pipe body 14 is larger than that of theintermediate pipe body 12. Distal diameter. The proximal end of the secondtransition pipe body 15 is connected with theintermediate pipe body 12, and the distal end of the secondtransition pipe body 15 is connected with thedistal pipe body 13. Correspondingly, the diameter of the proximal end of the secondtransition pipe body 15 is smaller than the diameter of the proximal end of the secondtransition pipe body 15. Distal diameter.

通过第一过渡管体14和第二过渡管体15，使得中间管体12分别与近端管体11、远端管体13之间形成平缓的过渡连接，避免因形状突变导致在局部形成类似“沟槽”的结构死角而引起内漏或局部血栓的风险。Through the firsttransition pipe body 14 and the secondtransition pipe body 15 , a gentle transition connection is formed between theintermediate pipe body 12 and theproximal pipe body 11 and thedistal pipe body 13 respectively, so as to avoid the local formation of similar Risk of endoleak or local thrombus due to the dead space of the "groove" structure.

支架主体1的每一段管体11、12、13、14、15均由一个或多个支撑架101以及由这些支撑架101支撑的覆膜102所组成。Each section of thetube body 11 , 12 , 13 , 14 , 15 of the stent main body 1 is composed of one or more support frames 101 and amembrane 102 supported by the support frames 101 .

特别地，将第一过渡管体14和第二过渡管体15处的支撑架101定义为过渡支撑架104。过渡支撑架104呈圆台状，以分别保持第一过渡管体14和第二过渡管体15的圆台状的结构形式。过渡支撑架104的小端面向中间管体12。In particular, thesupport brackets 101 at the firsttransition tube body 14 and the secondtransition tube body 15 are defined astransition support brackets 104 . Thetransition support frame 104 is in the shape of a truncated cone, so as to maintain the truncated structure of the firsttransition pipe body 14 and the secondtransition pipe body 15 respectively. The small end of thetransition support frame 104 faces themiddle pipe body 12 .

本实施例中，第一过渡管体14和第二过渡管体15上的过渡支撑架104均只设置有一个。可以理解的是，过渡支撑架104的数量并不受限制，当需要设置多个过渡支撑架104时，则多个过渡支撑架104均为圆台状，且位于同一圆台面上。In this embodiment, only onetransition support frame 104 is provided on the firsttransition pipe body 14 and the secondtransition pipe body 15 . It can be understood that the number of the transition supports 104 is not limited. When multiple transition supports 104 need to be provided, the plurality of transition supports 104 are all truncated and located on the same circular truncated surface.

而对于近端管体11、中间管体12和远端管体13，其各自的支撑架101相应地为圆柱形，从而保持各段管体11、12、13各自的等径结构形式。每段管体11、12、13上支撑架101均设置为相间隔的多个，使得各段管体11、12、13均具有良好的弯曲性能。For theproximal tube body 11 , theintermediate tube body 12 and thedistal tube body 13 , their respective support frames 101 are correspondingly cylindrical, so as to maintain the respective equal diameter structures of thetube bodies 11 , 12 and 13 . The supportingframes 101 on each section of thepipe body 11 , 12 , and 13 are arranged at intervals, so that each section of thepipe body 11 , 12 , and 13 has good bending performance.

较佳地，近端管体11上还设有后释放部件105，用于该覆膜支架100近端的后释放。该后释放部件105为径向可收缩的环状结构，固定在覆膜102上，并在朝近端方向突伸出覆膜102的近端边缘。该后释放部件105的结构与支撑架101的结构相同，但该后释放部件105仅有部分与覆膜102贴合。Preferably, theproximal tube body 11 is further provided with arear release member 105 for rear release of the proximal end of thestent graft 100 . Therear release member 105 is a radially retractable annular structure, fixed on themembrane 102 and protrudes from the proximal edge of themembrane 102 in the proximal direction. The structure of therear release part 105 is the same as that of thesupport frame 101 , but only a part of therear release part 105 is attached to thefilm 102 .

进一步地，该后释放部件105较佳地还沿周向突出设置倒刺(图中未示出)。倒刺可以设置多个。覆膜支架100释放后，倒刺可刺入人体血管以增加覆膜支架100释放后的稳定性。Further, therear release part 105 preferably also protrudes with barbs (not shown in the figure) along the circumferential direction. Barbs can be set more than one. After the stent-graft 100 is released, the barbs can pierce the blood vessels of the human body to increase the stability of the stent-graft 100 after it is released.

覆膜102的近端端部靠近边缘处设有多个显影标记106，用于手术时更好地观察覆膜支架100释放的位置。本实施例中，该显影标记106呈圆环或8字形结构，通过缝合或热压固定在覆膜102上。显影标记106由不透射材料制成，这些不透射材料包括但不限于：金、铂、钯、铑、钽，或这些金属的合金或复合物，以铂为例，其合金例如可为铂钨、铂铱等合金。The proximal end of themembrane 102 is provided with a plurality of developing marks 106 near the edge, so as to better observe the release position of the stent-graft 100 during the operation. In this embodiment, the developing mark 106 has a ring or figure-8 structure, and is fixed on thefilm 102 by sewing or heat pressing. The developing mark 106 is made of opaque materials, which include but are not limited to: gold, platinum, palladium, rhodium, tantalum, or alloys or composites of these metals, such as platinum, for example, the alloy can be platinum tungsten , platinum-iridium and other alloys.

参阅图1至图3，外分支2悬伸于支架主体1外部，其一端连接于中间管体12的侧壁，并在该中间管体12的侧壁上具有内开口21。外分支2从该内开口21处往远离中间管体12的方向延伸。Referring to FIGS. 1 to 3 , theouter branch 2 is suspended from the outside of the bracket body 1 , and one end of theouter branch 2 is connected to the side wall of themiddle pipe body 12 , and has aninner opening 21 on the side wall of themiddle pipe body 12 . Theouter branch 2 extends from theinner opening 21 in a direction away from themiddle pipe body 12 .

外分支2可为等径或非等径的管状结构。本实施例中，外分支2包括管状的薄膜22和固定于薄膜22表面的多个支撑圈23，多个支撑圈23沿外分支2的轴向间隔布置。各支撑圈23与支架主体1的支撑架101的结构形式相同，亦为可径向收缩或展开的环形结构。薄膜22可由任何合适的覆膜材料形成，包括但不限于：低孔隙度织造或针织聚酯、涤纶材料、膨胀型聚四氟乙烯、聚氨酯、硅酮、超高分子量聚乙烯或其他合适材料。Theouter branch 2 may be a tubular structure of equal or unequal diameter. In this embodiment, theouter branch 2 includes a tubular film 22 and a plurality of support rings 23 fixed on the surface of the film 22 , and the plurality of support rings 23 are arranged at intervals along the axial direction of theouter branch 2 . Eachsupport ring 23 has the same structural form as thesupport frame 101 of the stent main body 1 , and is also an annular structure that can be radially contracted or expanded. The membrane 22 may be formed from any suitable coating material including, but not limited to, low porosity woven or knitted polyester, dacron material, expanded polytetrafluoroethylene, polyurethane, silicone, ultra-high molecular weight polyethylene, or other suitable materials.

在其他未示出的结构中，外分支2还可以是裸支架的形式，例如网格状裸支架。In other structures not shown, theouter branch 2 may also be in the form of a bare stent, such as a grid-shaped bare stent.

外分支2的内开口21处缝合固定于中间管体12的覆膜102上，与中间管体12连接为一体，外分支2的内腔与中间管体12的内腔相连通。实际制作时，中间管体12的覆膜102上开设通孔，外分支2相应地缝合于通孔处。Theinner opening 21 of theouter branch 2 is sutured and fixed on themembrane 102 of themiddle tube body 12 , and is connected with themiddle tube body 12 as a whole. In actual production, through holes are formed on thecoating 102 of themiddle pipe body 12 , and theouter branches 2 are correspondingly sewn on the through holes.

外分支2的长度L2较佳为5mm～20mm。当覆膜支架100释放到治疗位置时，外分支2可释放到无名动脉中，因无名动脉在主动脉弓部最左端(即最近端)的位置，通过外分支2与无名动脉的配合，可以更好地稳定覆膜支架100的位置，使覆膜支架100整体不易移位。The length L2 of theouter branch 2 is preferably 5 mm˜20 mm. When the stent-graft 100 is released to the treatment site, theouter branch 2 can be released into the innominate artery. Because the innominate artery is located at the leftmost (ie, the most proximal) position of the aortic arch, the cooperation between theouter branch 2 and the innominate artery can be better. The position of thestent graft 100 is stabilized, so that theoverall stent graft 100 is not easily displaced.

外分支2上较佳还设置有显影件24。如图3所示，显影件24呈点状，沿外分支2的延伸方向间隔设置有多个。另外，沿内开口21的外周也可设置多个显影件24。显影件24采用不透射材料制成，通过缝合或热压而固定在薄膜22上。通过这些显影件24，便于手术时观察外分支2的位置，从而便于外接分支支架更快地经该外分支2导入无名动脉。Theouter branch 2 is preferably also provided with a developingmember 24 . As shown in FIG. 3 , the developingmembers 24 are dot-shaped, and a plurality of developingmembers 24 are provided at intervals along the extending direction of theouter branch 2 . In addition, a plurality of developingmembers 24 may be provided along the outer circumference of theinner opening 21 . The developingmember 24 is made of an opaque material, and is fixed on the film 22 by sewing or heat pressing. Through these developingmembers 24 , it is convenient to observe the position of theexternal branch 2 during the operation, so that the external branch stent can be introduced into the innominate artery through theexternal branch 2 more quickly.

仍然参阅图1至图3，第一内分支3整体上位于支架主体1内部，贴合固定于中间管体12的内壁。第一内分支3的一端部连接于中间管体12的侧壁，并在中间管体12的侧壁上具有第一外开口31。该第一外开口31相比于外分支2的内开口21更靠近远端。Still referring to FIGS. 1 to 3 , the firstinner branch 3 is located inside the bracket body 1 as a whole, and is fitted and fixed to the inner wall of theintermediate pipe body 12 . One end of the firstinner branch 3 is connected to the side wall of themiddle pipe body 12 and has a firstouter opening 31 on the side wall of themiddle pipe body 12 . The firstouter opening 31 is closer to the distal end than theinner opening 21 of theouter branch 2 .

第一内分支3与外分支2类似，为等径或非等径的管状结构，可以为裸支架或者带薄膜的支架，此处不再具体描述。同样地，中间管体12的覆膜102上对应第一内分支3开设通孔，而第一内分支3的第一外开口31即可缝合固定于覆膜102上。The firstinner branch 3 is similar to theouter branch 2, and is an equal-diameter or non-equal-diameter tubular structure, which may be a bare stent or a stent with a membrane, which will not be described in detail here. Similarly, thefilm 102 of themiddle tube body 12 has a through hole corresponding to the firstinner branch 3 , and the firstouter opening 31 of the firstinner branch 3 can be sewn and fixed on thefilm 102 .

除第一外开口31外，第一内分支3的其他部分位于中间管体12的内部，可以通过缝合或粘接的方式与中间管体12的内壁固定。Except for the firstouter opening 31 , other parts of the firstinner branch 3 are located inside theintermediate pipe body 12 and can be fixed to the inner wall of theintermediate pipe body 12 by sewing or bonding.

较佳地，第一内分支3从第一外开口31处沿着中间管体12的管壁向近端方向延伸。本实施例中，如图1所示，第一内分支3的延伸方向基本上与支架主体1的轴线L一致，第一内分支3的轴线与支架主体1的轴线L在同一平面内。Preferably, the firstinner branch 3 extends from the firstouter opening 31 to the proximal direction along the tube wall of themiddle tube body 12 . In this embodiment, as shown in FIG. 1 , the extending direction of the firstinner branch 3 is basically consistent with the axis L of the bracket body 1 , and the axis of the firstinner branch 3 and the axis L of the bracket body 1 are in the same plane.

第一内分支3上同样沿其延伸方向设置有多个显影件32，另外，第一外开口31的外周也可设置多个显影件32。该显影件32的相关特征与外分支2上的显影件24类似，此处不再重复介绍。The firstinner branch 3 is also provided with a plurality of developingmembers 32 along the extending direction thereof. In addition, a plurality of developingmembers 32 may also be provided on the outer periphery of the firstouter opening 31 . The relevant features of the developingmember 32 are similar to those of the developingmember 24 on theouter branch 2, and the description is not repeated here.

仍然参阅图1至图3，第二内分支4相比于第一内分支3更靠近远端，第二内分支4整体上也是位于中间管体12内，贴合固定于中间管体12的内壁。第二内分支4在中间管体12的侧壁上具有第二外开口41，第二外开口41相比于第一外开口31更靠近远端。Still referring to FIGS. 1 to 3 , the second inner branch 4 is closer to the distal end than the firstinner branch 3 , the second inner branch 4 is also located in themiddle pipe body 12 as a whole, and is fitted and fixed to themiddle pipe body 12 . inner wall. The second inner branch 4 has a second outer opening 41 on the side wall of themiddle pipe body 12 , and the secondouter opening 41 is closer to the distal end than the firstouter opening 31 .

第二内分支4从第二外开口41处沿着中间管体12的管壁向远端方向延伸。第二内分支4的延伸方向与第一内分支3的延伸方向相反，可避免血流入口被第一内分支3阻挡而无法进入血流的情况的发生。The second inner branch 4 extends from the secondouter opening 41 to the distal direction along the tube wall of theintermediate tube body 12 . The extending direction of the second inner branch 4 is opposite to the extending direction of the firstinner branch 3 , which can avoid the occurrence of a situation where the blood flow inlet is blocked by the firstinner branch 3 and cannot enter the blood flow.

第二内分支4同样地沿其延伸方向设置有多个显影件42，另外，第二外开口41的外周也可设置多个显影件42。第二内分支4的其他特征可参照第一内分支3，不再重复介绍。Similarly, the second inner branch 4 is provided with a plurality of developingmembers 42 along the extending direction thereof. In addition, a plurality of developingmembers 42 may also be provided on the outer periphery of the secondouter opening 41 . For other features of the second inner branch 4, reference may be made to the firstinner branch 3, and the description will not be repeated.

以图1的视图来看，内开口21、第一外开口31和第二外开口41大致在平行于支架主体1轴线L的同一直线上，三者间隔排布。可以理解的是，三者也可以是在周向上有一定的间隔。From the view of FIG. 1 , theinner opening 21 , the firstouter opening 31 and the secondouter opening 41 are roughly on the same line parallel to the axis L of the bracket body 1 , and are arranged at intervals. It can be understood that the three can also have a certain interval in the circumferential direction.

基于上述对覆膜支架100结构的介绍，再结合图4，该覆膜支架100在使用时通过输送器植入主动脉600重建主动脉600的血流通道。其中，支架主体1的近端管体11伸入主动脉600的升主动脉601一侧并贴合升主动脉601的血管壁，远端管体13位于主动脉600的降主动脉603一侧并贴合降主动脉603的血管壁，而中间管体12位于主动脉600的主动脉弓602部。外分支2伸入无名动脉700内，以便稳定覆膜支架100在主动脉600内的位置，使覆膜支架100整体不易移位。Based on the above description of the structure of the stent-graft 100 , and referring to FIG. 4 , the stent-graft 100 is implanted into theaorta 600 through a delivery device to reconstruct the blood flow channel of theaorta 600 during use. Theproximal tube body 11 of the stent body 1 extends into the ascendingaorta 601 side of theaorta 600 and adheres to the blood vessel wall of the ascendingaorta 601 , and thedistal tube body 13 is located on the descendingaorta 603 side of theaorta 600 Themiddle tube body 12 is located in theaortic arch 602 of theaorta 600 . Theouter branch 2 extends into theinnominate artery 700, so as to stabilize the position of thestent graft 100 in theaorta 600, so that theoverall stent graft 100 is not easily displaced.

对于主动脉600弓部的三个分支血管，可以分别选择合适的外接分支支架，再通过该覆膜支架100分别导入对应的分支血管中。For the three branch vessels in the arch of theaorta 600, appropriate external branch stents can be selected respectively, and then introduced into the corresponding branch vessels through the stent-graft 100 respectively.

具体地，第一分支支架200从外分支2内伸出，进入无名动脉700，重建主动脉600与无名动脉700之间的血流通道。第二分支支架300从第一内分支3内经第一外开口31伸出，再进入左颈总动脉800，重建主动脉600与左颈总动脉800之间的血流通道。第三分支支架400从第二内分支4内经第二外开口41伸出，再进入左锁骨下动脉900，重建主动脉600与左锁骨下动脉900之间的血流通道。Specifically, thefirst branch stent 200 protrudes from theouter branch 2 and enters theinnominate artery 700 to reconstruct the blood flow channel between theaorta 600 and theinnominate artery 700 . Thesecond branch stent 300 protrudes from the firstinner branch 3 through the firstouter opening 31 , and then enters the left commoncarotid artery 800 to reconstruct the blood flow channel between theaorta 600 and the left commoncarotid artery 800 . Thethird branch stent 400 protrudes from the second inner branch 4 through the secondouter opening 41 , and then enters the leftsubclavian artery 900 to reconstruct the blood flow channel between theaorta 600 and the leftsubclavian artery 900 .

植入过程大致如下：The implantation process is roughly as follows:

1、先释放覆膜支架100的近端管体11；1. First release theproximal tube body 11 of the stent-graft 100;

2、继续释放中间管体12的近端部分，外分支2内埋设预置导丝，当外分支2中的预置导丝释放出来后，用抓捕器或其它器械将导丝送进无名动脉700中，将外分支2送入无名动脉700内；2. Continue to release the proximal part of themiddle tube body 12, and a preset guide wire is embedded in theouter branch 2. When the preset guide wire in theouter branch 2 is released, use a catcher or other instruments to feed the guide wire into the unnamed In theartery 700, theouter branch 2 is sent into theinnominate artery 700;

3、快速释放支架主体1的其他部分，并完成近端管体11后释放部件105的后释放，使覆膜支架100锚定于主动脉600内；3. Quickly release other parts of the stent body 1, and complete the post-release of theproximal tube body 11 after therelease member 105, so that the stent-graft 100 is anchored in theaorta 600;

4、通过导丝、导管交换技术，依次重建无名动脉700、左颈总动脉800、左锁骨下动脉900三个分支血管，分别释放相应规格的分支支架200、300、400，具体地，将第一分支支架200释放在外分支2内重建无名动脉700，将第二分支支架300释放在第一内分支3内重建左颈总动脉800，将第三分支支架400释放在第二内分支4内重建左锁骨下动脉900。4. The three branch vessels of theinnominate artery 700, the left commoncarotid artery 800, and the leftsubclavian artery 900 are reconstructed in turn through the technique of guide wire and catheter exchange, andbranch stents 200, 300, and 400 of corresponding specifications are released respectively. Onebranch stent 200 is released in theouter branch 2 to reconstruct theinnominate artery 700, thesecond branch stent 300 is released in the firstinner branch 3 to reconstruct the left commoncarotid artery 800, and thethird branch stent 400 is released in the second inner branch 4 for reconstruction Leftsubclavian artery 900.

根据上述的介绍可知，本实施例的覆膜支架100中，在支架主体1上一体形成有外分支2、第一内分支3和第二内分支4，这些分支2、3、4可以分别向外接的三个分支支架200、300、400对应提供定位以及支撑功能，并且，这些分支2、3、4位于支架主体1的管径较小的中间管体12处，由于在中间管体12处形成了凹部103，相应地，该凹部103与主动脉弓602的血管壁之间形成一定的间隙，能够在腔内治疗时给予导丝和导管足够的操作空间，便于在手术过程中将外接的这三个分支支架200、300、400快速送入分支动脉内，以重建主动脉600弓部的三个主要分支动脉血流通道。同时，由于中间管体12的直径较小，在各分支支架200、300、400植入血管后，覆膜支架100也不会挤压到分支血管造成分支血管堵塞。各分支支架200、300、400分别对应利用外分支2、第一内分支3和第二内分支4与覆膜支架100锚定，手术操作更为简单，缩短手术过程。According to the above description, in thestent graft 100 of the present embodiment, anouter branch 2 , a firstinner branch 3 and a second inner branch 4 are integrally formed on the stent body 1 . The three external branch supports 200 , 300 , and 400 provide positioning and support functions correspondingly, and thesebranches 2 , 3 , and 4 are located at themiddle pipe body 12 of the stent body 1 with a smaller diameter. Theconcave portion 103 is formed, correspondingly, a certain gap is formed between theconcave portion 103 and the blood vessel wall of theaortic arch 602, which can give the guide wire and the catheter enough operating space during the endoluminal treatment, so as to facilitate the external connection of these three parts during the operation. Thebranch stents 200 , 300 and 400 are rapidly delivered into the branch arteries to reconstruct the blood flow channels of the three main branch arteries in the arch of theaorta 600 . Meanwhile, due to the small diameter of theintermediate tube body 12, after eachbranch stent 200, 300, 400 is implanted into the blood vessel, thestent graft 100 will not squeeze the branch blood vessel and cause the branch blood vessel to be blocked. Eachbranch stent 200 , 300 , 400 is anchored to thestent graft 100 by using theouter branch 2 , the firstinner branch 3 and the second inner branch 4 respectively, which makes the operation simpler and shortens the operation process.

特别地，覆膜支架100的这多个分支2、3、4中，最近端的分支为悬伸于支架主体1外部的外分支2，在覆膜支架100送入主动脉600的预定位置时，外分支2可以伸入无名动脉700中，从而便于确定覆膜支架100是否输送到位；同时在外分支2释放后，基于外分支2与无名动脉700的配合，配合支架主体1与主动脉600的配合，使得覆膜支架100整体不易移位，方便后续分支支架的植入。位于外分支2更远端的两个内分支3、4均是位于支架主体1的内部，两个内分支3、4不超出支架主体1，而是仅在支架主体1的侧壁暴露出外开口31、41，配合凹部103所提供的操作空间，使得分支支架经内分支3、4向分支动脉血管植入时可以有更大的位置调整空间，更方便地植入分支动脉血管，内分支3、4无需准确地与分支动脉血管的入口相对，因而覆膜支架100具有更广的适用性和更高的通用性。In particular, among themultiple branches 2 , 3 , and 4 of thestent graft 100 , the most proximal branch is theouter branch 2 overhanging the outside of the stent body 1 . When thestent graft 100 is delivered to the predetermined position of theaorta 600 , Theouter branch 2 can extend into theinnominate artery 700, so that it is convenient to determine whether thestent graft 100 is delivered in place; at the same time, after theouter branch 2 is released, based on the cooperation between theouter branch 2 and theinnominate artery 700, the stent body 1 and theaorta 600 cooperate with each other. , so that the stent-graft 100 is not easily displaced as a whole, which facilitates the implantation of subsequent branch stents. The twoinner branches 3 and 4 located at the farther end of theouter branch 2 are both located inside the stent body 1 , and the twoinner branches 3 and 4 do not extend beyond the stent body 1 , but only expose the outer opening on the side wall of the stent body 1 . 31, 41, cooperate with the operation space provided by therecess 103, so that when the branch stent is implanted into the branch artery through theinner branches 3 and 4, there can be a larger space for position adjustment, and the branch artery can be implanted more conveniently, and theinner branch 3 , 4 do not need to be exactly opposite to the inlet of the branch artery, so thestent graft 100 has wider applicability and higher versatility.

此外，本实施例中，相对靠近外分支2的第一内分支3为顺行内分支，其内的血流方向与主动脉600血流方向一致，不易形成血栓。In addition, in this embodiment, the firstinner branch 3 that is relatively close to theouter branch 2 is an antegrade inner branch, and the blood flow direction in the inner branch is consistent with the blood flow direction of theaorta 600 , so that thrombus is not easily formed.

进一步地，第二内分支4的延伸方向与第一内分支3的延伸方向相反，可避免血流入口被第一内分支3阻挡而无法进入血流的情况的发生。其中，由于在使用时第二内分支4靠近降主动脉603一侧，第二内分支4的延伸方向与降主动脉603的延伸方向一致，第二内分支4向远端的延伸不会影响到血流向其内流入。Further, the extending direction of the second inner branch 4 is opposite to the extending direction of the firstinner branch 3 , which can avoid the occurrence of a situation where the blood flow inlet is blocked by the firstinner branch 3 and cannot enter the blood flow. Wherein, since the second inner branch 4 is close to the descendingaorta 603 during use, the extension direction of the second inner branch 4 is consistent with the extension direction of the descendingaorta 603, and the extension of the second inner branch 4 to the distal end will not affect the into the blood flow into it.

第二实施例，请参阅图5所示的结构。For the second embodiment, please refer to the structure shown in FIG. 5 .

本实施例的覆膜支架100a相较于第一实施例的主要不同在于：第一内分支3a的延伸方向不一样。The main difference between thestent graft 100a of this embodiment and the first embodiment is that the extension directions of the firstinner branches 3a are different.

如图5所示，本实施例中，第一内分支3a仍然是从第一外开口31a处向近端延伸，但随着向近端方向的延伸，第一内分支3a还从第一外开口31a处沿着支架主体1a的周向延伸。As shown in FIG. 5 , in this embodiment, the firstinner branch 3a still extends proximally from the firstouter opening 31a, but along with the proximal extension, the firstinner branch 3a also extends from the firstouter opening 31a to the proximal end. Theopening 31a extends along the circumferential direction of the holder main body 1a.

第一内分支3a在支架主体1a内部的延伸形状大致地可认为是一小段螺旋线的形状。第一内分支3a的轴线所在平面与支架主体1a的轴线L之间具有夹角α，该夹角α大于0度小于90度。The extending shape of the firstinner branch 3a inside the stent main body 1a can be roughly regarded as the shape of a small helix. There is an included angle α between the plane where the axis of the firstinner branch 3a is located and the axis L of the bracket body 1a, and the included angle α is greater than 0 degrees and less than 90 degrees.

根据第一内分支3a的延伸方式，当第一内分支3a的延伸长度较长时，也不会遮挡外分支2a的内开口21a，从而主动脉血流可以顺利经内开口21a进入外分支2a再进入无名动脉中。另一方面，当外分支2a中接入分支支架时，分支支架会向支架主体1a内壁延伸一定的长度作为锚定区，通过第一内分支3a相对于支架主体1a的轴线L倾斜延伸的设置，可以避免接入外分支2a的分支支架与第一内分支3a的相互干扰。According to the extension method of the firstinner branch 3a, when the extension length of the firstinner branch 3a is long, theinner opening 21a of theouter branch 2a will not be blocked, so that the aortic blood flow can smoothly enter theouter branch 2a through theinner opening 21a into the innominate artery. On the other hand, when the branch stent is inserted into theouter branch 2a, the branch stent will extend to the inner wall of the stent body 1a for a certain length as an anchoring area, and the firstinner branch 3a extends obliquely with respect to the axis L of the stent body 1a. , the mutual interference between the branch support connected to theouter branch 2a and the firstinner branch 3a can be avoided.

本实施例的覆膜支架100a中，支架主体1a、外分支2a及第二内分支4a的设置及结构与第一实施例相同，不再重复描述。In thestent graft 100a of this embodiment, the arrangement and structure of the stent main body 1a, theouter branch 2a and the secondinner branch 4a are the same as those of the first embodiment, and the description is not repeated.

第三实施例，请参阅图6所示的结构。For the third embodiment, please refer to the structure shown in FIG. 6 .

本实施例的覆膜支架100b相较于第二实施例的不同之处在于：第一内分支3b的显影件32b和第二内分支4b的显影件42b均呈线状延伸。Compared with the second embodiment, thestent graft 100b of this embodiment is different in that both the developingmember 32b of the firstinner branch 3b and the developingmember 42b of the secondinner branch 4b extend linearly.

如图6，显影件32b沿第一内分支3b的轴向延伸，其可为连续的显影丝构成，或者呈线状连续缠绕在第一内分支3b的金属骨架上。显影件42b同样沿第二内分支4b的轴向延伸。As shown in FIG. 6 , the developingmember 32b extends along the axial direction of the firstinner branch 3b, which may be formed of continuous developing wires, or continuously wound on the metal frame of the firstinner branch 3b in a linear shape. The developingmember 42b also extends in the axial direction of the secondinner branch 4b.

相比于第一实施例中点状的显影件32、42，本实施例的线状显影件32b、42b为连续的形状，在设置多个分散显影的情况下，能够更快的观察到第一内分支3b和第二内分支4b的位置。Compared with the point-shaped developingmembers 32 and 42 in the first embodiment, the linear developingmembers 32b and 42b in this embodiment are in a continuous shape. Location of aninner branch 3b and a secondinner branch 4b.

第四实施例，请参阅图7所示的结构。For the fourth embodiment, please refer to the structure shown in FIG. 7 .

本实施例的覆膜支架100c相较于第二实施例的不同之处在于：第二内分支4c的延伸方向不一样。Compared with the second embodiment, thestent graft 100c of this embodiment is different in that the extending direction of the secondinner branch 4c is different.

如图7所示，第二内分支4c仍然是从第二外开口41c处向远端延伸，但随着向远端方向的延伸，第二内分支4c还从第二外开口41c处沿着支架主体1c的周向延伸。As shown in FIG. 7 , the secondinner branch 4c still extends distally from the secondouter opening 41c, but along with the extension in the distal direction, the secondinner branch 4c also extends from the secondouter opening 41c along the The circumferential direction of the holdermain body 1c extends.

第二内分支4c在支架主体1c内部的延伸形状同样地可大致认为是一小段螺旋线的形状。第二内分支4c的轴线所在平面与支架主体1c的轴线L之间具有夹角β，该夹角β大于0度小于90度。The extending shape of the secondinner branch 4c inside thestent body 1c can also be roughly regarded as the shape of a small helix. There is an included angle β between the plane where the axis of the secondinner branch 4c is located and the axis L of thebracket body 1c, and the included angle β is greater than 0 degrees and less than 90 degrees.

根据该第二内分支4c的延伸方式，在覆膜支架100c植入到主动脉时，第二内分支4c可处于主动脉弓的弓部弯折区域，第二内分支4c相对于支架主体1c轴线L倾斜设置的方式，可以避开覆膜102c因弯曲而堆叠的区域，防止被覆膜102c遮挡入口。According to the extension of the secondinner branch 4c, when the stent-graft 100c is implanted into the aorta, the secondinner branch 4c can be located in the bending region of the arch of the aortic arch, and the secondinner branch 4c is relative to the axis L of thestent body 1c The inclined arrangement can avoid the area where the coveringfilms 102c are stacked due to bending, and prevent the coveringfilms 102c from blocking the entrance.

图7所示的结构中，第二内分支4c沿周向延伸的方向与第一内分支3c沿周向延伸的方向相同，即第二内分支4c与第一内分支3c位于第二外开口41c与第一外开口31c连线的同一侧。在其他未示出的结构中，第二内分支4c也可以是与第一内分支3c沿周向延伸的方向相反。In the structure shown in FIG. 7 , the direction in which the secondinner branch 4c extends in the circumferential direction is the same as the direction in which the firstinner branch 3c extends in the circumferential direction, that is, the secondinner branch 4c and the firstinner branch 3c are located in the secondouter opening 41c is on the same side of the line connecting the firstouter opening 31c. In other structures not shown, the secondinner branch 4c may also be in a direction opposite to the circumferential extending direction of the firstinner branch 3c.

本实施例的覆膜支架100c中，支架主体1c、外分支2c及第一内分支3c的设置及结构与第二实施例相同，不再重复描述。In thestent graft 100c of this embodiment, the arrangement and structure of the stentmain body 1c, theouter branch 2c and the firstinner branch 3c are the same as those of the second embodiment, and will not be described again.

第五实施例，请参阅图8所示的结构。For the fifth embodiment, please refer to the structure shown in FIG. 8 .

本实施例的覆膜支架100d相较于第二实施例的不同之处在于：第二内分支4d的延伸方向不一样。The difference between thestent graft 100d of this embodiment and the second embodiment is that the extending directions of the secondinner branches 4d are different.

如图8所示，本实施例中，第二内分支4d从第二外开口41d处向近端方向延伸，且随着向近端方向的延伸，第二内分支4d还从第二外开口41d处沿着支架主体1a周向延伸。As shown in FIG. 8 , in this embodiment, the secondinner branch 4d extends from the secondouter opening 41d to the proximal direction, and along with the extension toward the proximal direction, the secondinner branch 4d also extends from the secondouter opening 41d extends along the circumferential direction of the stent main body 1a.

第二内分支4d在支架主体1d内部的延伸形状同样地可大致认为是一小段螺旋线的形状。第二内分支4d的轴线所在平面与支架主体1d的轴线L之间具有夹角θ，该夹角θ大于0度小于90度。The extending shape of the secondinner branch 4d inside the stent body 1d can also be roughly regarded as the shape of a small helix. There is an included angle θ between the plane where the axis of the secondinner branch 4d is located and the axis L of the bracket body 1d, and the included angle θ is greater than 0 degrees and less than 90 degrees.

其中，第二内分支4d沿周向延伸的方向与第一内分支3d沿周向延伸的方向相背离。两者分列第一外开口31d与第二外开口41d连线的两侧。以图8的视图方向为参照，第一内分支3d向左侧延伸，第二内分支4d向右侧延伸。The direction in which the secondinner branch 4d extends in the circumferential direction is opposite to the direction in which the firstinner branch 3d extends in the circumferential direction. The two are arranged on two sides of the line connecting the firstouter opening 31d and the secondouter opening 41d. Referring to the view direction of FIG. 8 , the firstinner branch 3d extends to the left, and the secondinner branch 4d extends to the right.

本实施例中，第二内分支4d也为顺行分支，与血流方向一致。第二内分支4d与第一内分支3d均倾斜延伸，且倾斜方向相反，可以防止相互干扰。In this embodiment, the secondinner branch 4d is also an antegrade branch, which is consistent with the direction of blood flow. Both the secondinner branch 4d and the firstinner branch 3d extend obliquely, and the inclination directions are opposite, which can prevent mutual interference.

第六实施例，请参阅图9所示的结构。For the sixth embodiment, please refer to the structure shown in FIG. 9 .

本实施例的覆膜支架100e相较于第一实施例的不同之处在于：外分支2e的长度较短，其长度约为第一实施例中外分支2长度的1/3～1/2。该外分支2e的薄膜22e上只设有一个支撑圈23e。Compared with the first embodiment, thestent graft 100e of this embodiment is different in that the length of theouter branch 2e is shorter, and its length is about 1/3-1/2 of the length of theouter branch 2 in the first embodiment. Only onesupport ring 23e is provided on themembrane 22e of theouter branch 2e.

本实施例设置了较短的外分支2e，其在植入时，灵活性增加，能适应不同解剖结构的患者。此时较短的外分支2e可作为外接分支支架的固定端，对无名动脉的位置没有严格的限定。In this embodiment, a shorterouter branch 2e is provided, which increases flexibility during implantation and can adapt to patients with different anatomical structures. At this time, the shorterouter branch 2e can be used as the fixed end of the outer branch stent, and the position of the innominate artery is not strictly limited.

本实施例的覆膜支架100e中，支架主体1e、第一内分支3e及第二内分支4e的设置及结构与第一实施例相同，不再重复描述。In thestent graft 100e of this embodiment, the arrangement and structure of the stent main body 1e, the firstinner branch 3e and the secondinner branch 4e are the same as those of the first embodiment, and will not be described again.

第七实施例，请参阅图10所示的结构。For the seventh embodiment, please refer to the structure shown in FIG. 10 .

本实施例的覆膜支架100f相较于第一实施例的不同之处在于：外分支2f的结构不同。Thestent graft 100f of this embodiment is different from the first embodiment in that the structure of theouter branch 2f is different.

如图10所示，本实施例中，外分支2f具有可柔性变形的柔性段221f，柔性段221f从内开口21f处向外延伸。柔性段221由柔性薄膜材料构成，其上不设置支撑结构，从而可以具有较大的柔顺性，能够适应更多解剖结构的患者。柔性段221长度大致为2mm～10mm，且不超过外分支2f总长度的1/2。As shown in FIG. 10 , in this embodiment, theouter branch 2f has aflexible segment 221f that can be flexibly deformed, and theflexible segment 221f extends outward from theinner opening 21f. The flexible segment 221 is made of a flexible film material without a supporting structure, so that it can have greater flexibility and can adapt to patients with more anatomical structures. The length of the flexible section 221 is approximately 2mm˜10mm, and does not exceed 1/2 of the total length of theouter branch 2f.

该柔性段221f可以是通过薄膜22f靠近支架主体1f的一段长度范围内不设置支撑圈23f而形成。即：该外分支2f的薄膜22f上从内开口21f开始的约2mm～10mm范围内不设置支撑圈23f，薄膜22f上未设置支撑圈23f的这一段即构成柔性段221f。除柔性段221f之外的部分薄膜22f上再设置支撑圈23f以保持外分支2f呈管状。Theflexible section 221f may be formed by not disposing thesupport ring 23f within a length range of thefilm 22f close to the stent main body 1f. That is, thefilm 22f of theouter branch 2f is not provided with asupport ring 23f within a range of about 2mm-10mm from theinner opening 21f, and the portion of thefilm 22f without thesupport ring 23f constitutes theflexible segment 221f. Asupport ring 23f is further provided on the part of thefilm 22f except theflexible section 221f to keep theouter branch 2f in a tubular shape.

本实施例的覆膜支架100f中，支架主体1f、第一内分支3f及第二内分支4f的设置及结构与第一实施例相同，不再重复描述。In thestent graft 100f of this embodiment, the arrangement and structure of the stent body 1f, the firstinner branch 3f and the secondinner branch 4f are the same as those of the first embodiment, and the description is not repeated.

上述几个实施例中，均是以在支架主体上设有两个内分支的结构进行的介绍，由此结合外分支的设置可以重建主动脉的三个分支动脉血管。但可以理解的是，在一些未示出的实施例中，内分支的数量也可以减少到一个，由此适用于需要重建两个分支动脉的情形。In the above-mentioned several embodiments, the structure of two inner branches is provided on the main body of the stent. Therefore, the three branch arteries of the aorta can be reconstructed in combination with the arrangement of the outer branches. However, it can be understood that, in some unshown embodiments, the number of inner branches can also be reduced to one, which is suitable for the situation where two branch arteries need to be reconstructed.

结合上述几个实施例的具体介绍可知，采用本发明的覆膜支架，可以使得主动脉支架和外接分支动脉支架为分别独立的结构，适用于各种正常及走形变异的血管，可以根据病变的具体情况，分别选择合适尺寸的主动脉支架血管和分支动脉支架血管，组合成一套最适合患者的支架血管系统，避免定制支架，可以批量生产，并有效节省时间与操作容易的功效。Combining the specific introduction of the above-mentioned embodiments, it can be seen that the stent-graft of the present invention can make the aortic stent and the external branch artery stent to be independent structures, which are suitable for various normal and deformed blood vessels, and can be adjusted according to the pathological changes. According to the specific situation, the aortic stents and branch artery stents of appropriate size are selected respectively, and combined into a set of stent vascular system that is most suitable for patients, avoiding custom stents, mass production, and effective time saving and easy operation.

虽然已参照几个典型实施方式描述了本发明，但应当理解，所用的术语是说明和示例性、而非限制性的术语。由于本发明能够以多种形式具体实施而不脱离发明的精神或实质，所以应当理解，上述实施方式不限于任何前述的细节，而应在随附权利要求所限定的精神和范围内广泛地解释，因此落入权利要求或其等效范围内的全部变化和改型都应为随附权利要求所涵盖。While the present invention has been described with reference to several exemplary embodiments, it is to be understood that the terminology used is of description and illustration, and not of limitation. Since the invention can be embodied in many forms without departing from the spirit or spirit of the invention, it is to be understood that the above-described embodiments are not limited to any of the foregoing details, but are to be construed broadly within the spirit and scope defined by the appended claims Therefore, all changes and modifications that come within the scope of the claims or their equivalents should be covered by the appended claims.