CN115300178A - A branched stent-graft - Google Patents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2002/077—Stent-grafts having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
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Abstract
本发明提供一种分支覆膜支架,包括支撑框架和覆膜,所述覆膜附着在所述支撑框架上,所述支撑框架包括支架支撑段、支架缩径段和连接锚固段,所述支架支撑段和所述连接锚固段位于所述支架缩径段的两端,所述支架缩径段与所述连接锚固段连接的一端的直径小于所述支架支撑段的直径,且所述连接锚固段远离与所述支架缩径段连接的一端的直径大于所述支架支撑段的直径。本发明对主体覆膜支架的稳固效果和自身的锚固效果较好,可以更紧密的贴合预开孔,完成密封,防止内漏,以及能够避免弯曲产生的锐利峰角触碰到血管内壁,划伤血管,从而保证其安全性。
The present invention provides a branched stent-graft, which includes a support frame and a membrane, the membrane is attached to the support frame, and the support frame includes a stent support section, a stent diameter-reducing section and a connecting anchor section, and the stent The support section and the connection anchor section are located at both ends of the stent reducing section, the diameter of one end of the stent reducing section connected to the connecting anchor section is smaller than the diameter of the stent support section, and the connecting anchor The diameter of the end of the segment away from the connection with the reduced diameter segment of the stent is larger than the diameter of the support segment of the stent. The present invention has better stabilizing effect on the main body covered stent and self-anchoring effect, can more closely fit the pre-opening hole, complete the sealing, prevent internal leakage, and can avoid the sharp peak angle generated by bending from touching the inner wall of the blood vessel, Scratch blood vessels, thus ensuring their safety.
Description
技术领域technical field
本发明涉及医疗器械,具体涉及了一种分支覆膜支架。The invention relates to a medical device, in particular to a branch covered stent.
背景技术Background technique
主动脉夹层(Aortic Dissection,AD)是指主动脉病变部位的血管内膜与中膜发生分离的一种疾病,主动脉腔内修复术是一种微创介入治疗手术,在利用主动脉腔内修复术治疗主动脉夹层的过程中,通过经皮刺穿血管,并利用特定的输送装置在病变血管部位释放一种人造管状假体(即覆膜支架),使用人造假体封闭破裂的血管内膜,重建新的血液通道,隔绝主动脉高压血流对病变区域的冲击,实现对主动脉夹层的治疗。主动脉腔内修复术较开放手术创伤小,且较保守治疗有更好的远期主动脉重塑等优点。Aortic dissection (Aortic Dissection, AD) refers to a disease in which the intima and media of the aortic lesion are separated. Endovascular aortic repair is a minimally invasive interventional surgery. In the process of repairing aortic dissection, the blood vessel is percutaneously punctured, and a specific delivery device is used to release an artificial tubular prosthesis (ie, covered stent) at the site of the diseased blood vessel, and the artificial prosthesis is used to seal the ruptured blood vessel. Membrane, rebuild new blood channel, isolate the impact of aortic high pressure blood flow on the lesion area, and realize the treatment of aortic dissection. Compared with open surgery, endovascular aortic repair has less trauma, and has better long-term aortic remodeling than conservative treatment.
主动脉弓部结构复杂,分支血管分叉角度多变,血流速度快。当夹层累及弓上分支血管时,单纯运用主动脉腔内修复术可能存在阻碍分支血管供血、锚定区不足等问题。随着医疗水平的提高及介入材料的不断创新,预开窗和分支支架技术的发展,使得腔内修复术治疗主动脉弓部疾病成为可能。预开窗技术覆膜支架与分支血管的对应预先设置开孔,以防止覆膜支架封闭分支血管,阻碍分支血管供血,分支支架技术在覆膜支架的预开孔内再植入分支覆膜支架,联通主体覆膜支架和分支血管,以稳固主体覆膜支架的锚定区、防止预开孔内漏、重建分支血管、提高主动脉腔内修复术的治疗效果。而现有的技术存在的缺陷:The structure of the aortic arch is complex, the bifurcation angles of the branch vessels are changeable, and the blood flow is fast. When the dissection involves the supra-arch branch vessels, simple endovascular repair of the aorta may have problems such as obstructing the blood supply of the branch vessels and insufficient anchoring area. With the improvement of medical level and continuous innovation of interventional materials, the development of pre-fenestration and branch stent technology makes it possible to treat aortic arch diseases with endovascular repair. Pre-fenestration technology The pre-opening of the stent-graft and the branch vessel is pre-set to prevent the stent-graft from sealing the branch vessel and hindering the blood supply of the branch vessel. The branch-stent technology implants the branch stent-graft in the pre-opening hole of the stent-graft , Unicom main body covered stent and branch blood vessels to stabilize the anchoring area of the main body covered stent, prevent pre-opening endoleak, reconstruct branch blood vessels, and improve the therapeutic effect of aortic endoluminal repair. And the defective that existing technology exists:
传统分支覆膜支架在植入血管后,其与主体覆膜支架的连接形态不佳,连接处易产生间隙,引起血液内漏,危害患者健康;传统分支覆膜支架在植入血管后,由于分支血管分叉角度多变,分支覆膜支架无法适配各种弯曲形态的分支血管,异常弯曲的分支覆膜支架易形成锐角,划伤分支血管内壁,危害患者健康;以及传统分支覆膜支架在植入血管后,由于其与主体覆膜支架的连接形态不佳,其对主体覆膜支架的稳固效果和自身的锚固效果下降,易产生转动、位移等,危害患者健康。After the traditional branch stent-graft is implanted into the blood vessel, its connection form with the main stent-graft is not good, and the connection is prone to produce gaps, causing blood leakage and endangering the health of patients; after the traditional branch stent-graft is implanted in the blood vessel, due to The bifurcation angles of branch vessels are variable, and branch covered stents cannot adapt to various curved branch vessels. Abnormally curved branch covered stents tend to form acute angles, scratching the inner wall of branch vessels, and endangering the health of patients; and traditional branch covered stents After being implanted into a blood vessel, due to its poor connection with the main stent graft, its stabilization effect on the main stent graft and its own anchoring effect are reduced, and rotation and displacement are prone to occur, endangering the health of patients.
发明内容Contents of the invention
有鉴于此,本发明的主要目的在于提供一种分支覆膜支架,以解决与主体覆膜支架的连接形态不佳,连接处易产生间隙,引起血液内漏;主体覆膜支架的稳固效果和自身的锚固效果下降,易产生转动、位移等;以及分支覆膜支架无法适配各种弯曲形态的分支血管,异常弯曲的分支覆膜支架易形成锐角,划伤分支血管内壁,从而危害患者健康的问题。In view of this, the main purpose of the present invention is to provide a branch covered stent to solve the poor connection form with the main body covered stent, and the joint is prone to produce gaps, causing blood endoleak; the stabilization effect of the main body covered stent and The anchoring effect of itself is reduced, and it is prone to rotation, displacement, etc.; and the branch covered stent cannot adapt to various curved branch vessels, and abnormally curved branch covered stents are likely to form sharp angles, scratching the inner wall of branch vessels, thus endangering the health of patients The problem.
为实现上述目的及其他相关目的,本发明提出一种分支覆膜支架,包括支撑框架和覆膜,所述覆膜附着在所述支撑框架上,To achieve the above purpose and other related purposes, the present invention proposes a branched stent graft, comprising a support frame and a film, the film is attached to the support frame,
所述支撑框架包括支架支撑段、支架缩径段和连接锚固段,所述支架支撑段和所述连接锚固段位于所述支架缩径段的两端,所述支架缩径段与所述连接锚固段连接的一端的直径小于所述支架支撑段的直径,且所述连接锚固段远离与所述支架缩径段连接的一端的直径大于所述支架支撑段的直径。The support frame includes a bracket support section, a bracket diameter reduction section and a connecting anchor section, the bracket support section and the connection anchor section are located at both ends of the bracket diameter reduction section, and the bracket diameter reduction section is connected to the The diameter of the connecting end of the anchoring section is smaller than the diameter of the supporting section of the stent, and the diameter of the end of the connecting anchoring section away from the connection with the narrowing section of the stent is larger than the diameter of the supporting section of the stent.
在本发明的一个实施例中,所述支撑框架由一根或若干根金属丝缠绕弯曲制成,其横截面为圆形,且所述支撑框架的任一圈呈波浪状。In one embodiment of the present invention, the support frame is made of one or several wires twisted and bent, the cross section of which is circular, and any turn of the support frame is wavy.
在本发明的一个实施例中,所述支撑框架包括多个独立的金属丝圆环沿轴向排列形成,且每个独立的所述圆环在周向上呈波浪状。In one embodiment of the present invention, the support frame includes a plurality of independent metal wire rings arranged in an axial direction, and each independent ring is wavy in the circumferential direction.
在本发明的一个实施例中,所述支撑框架相邻两圈之间的距离设置在3mm至20mm之间。In one embodiment of the present invention, the distance between two adjacent turns of the support frame is set between 3mm and 20mm.
在本发明的一个实施例中,每个所述波浪状的在轴向上波峰至波谷之间的距离设置在3mm至15mm之间。In one embodiment of the present invention, the distance between the crests and troughs of each wave shape in the axial direction is set between 3mm and 15mm.
在本发明的一个实施例中,所述金属丝的横截面为圆形或正方形,其圆形的直径或正方形外接圆的直径设置在0.1mm至1mm之间。In one embodiment of the present invention, the metal wire has a circular or square cross-section, and the diameter of the circle or the circumscribed circle of the square is set between 0.1 mm and 1 mm.
在本发明的一个实施例中,所述支架支撑段在轴向上的直径相同。In one embodiment of the present invention, the diameters of the stent support segments in the axial direction are the same.
在本发明的一个实施例中,所述支架缩径段包括变径区和小径区,所述变径区位于所述支架支撑段和所述小径区之间。In an embodiment of the present invention, the reduced-diameter section of the stent includes a reduced-diameter area and a small-diameter area, and the reduced-diameter area is located between the support section of the stent and the small-diameter area.
在本发明的一个实施例中,所述变径区的直径沿着所述支架支撑段指向所述连接锚固段的方向逐渐减小。In one embodiment of the present invention, the diameter of the diameter reducing area gradually decreases along the direction from the stent support segment to the connecting anchor segment.
在本发明的一个实施例中,所述小径区沿其轴向的直径不变。In one embodiment of the present invention, the diameter of the small-diameter zone along its axial direction is constant.
在本发明的一个实施例中,所述小径区的直径沿着所述支架支撑段指向所述连接锚固段的方向逐渐减小。In one embodiment of the present invention, the diameter of the small-diameter region decreases gradually along the direction from the stent support segment to the connecting anchor segment.
在本发明的一个实施例中,所述连接锚固段远离所述支架缩径段一端的支撑框架周向上呈波浪状。In one embodiment of the present invention, the supporting frame at the end of the connecting anchoring section away from the narrowing section of the stent is wave-shaped in the circumferential direction.
在本发明的一个实施例中,所述覆膜沿着所述波浪状的波峰连接,使所述连接锚固段呈圆台状,或沿着呈所述波浪状的金属丝连接,使所述连接锚固段呈花瓣状。In one embodiment of the present invention, the covering film is connected along the wavy crest, so that the connection anchoring section is in the shape of a truncated cone, or connected along the wavy metal wire, so that the connection The anchoring segment is petal-shaped.
在本发明的一个实施例中,所述连接锚固段的一端与所述支架缩径段连接,另一端朝向所述支架支撑段的方向向外翻折,使所述连接锚固段呈倒圆台状。In one embodiment of the present invention, one end of the connecting anchor section is connected to the reduced-diameter section of the stent, and the other end is folded outward toward the support section of the stent, so that the connecting anchor section has a rounded truncated shape. .
本发明提出一种分支覆膜支架,当所述分支覆膜支架植入弯曲的主动脉弓后,所述连接锚固段必会有一段直径和预开孔直径相同,所以连接锚固段可以更紧密的贴合预开孔,完成密封,防止内漏。The present invention proposes a branched stent graft. When the branched stent graft is implanted into a curved aortic arch, the connecting anchoring section must have a section with the same diameter as the pre-opening hole, so the connecting anchoring section can be more tightly attached. Combined with pre-opening holes to complete the seal and prevent internal leakage.
本发明提出一种分支覆膜支架,主体覆膜支架在预开孔上设计了一个调节圆台,圆台的小环依靠覆膜与预开孔相连,并适量移动,以适应不同分支血管解剖结构,当本发明所述分支覆膜支架与该主体覆膜支架搭配使用时,圆台型的连接锚固段与圆台型的调节圆台相互适配,增加接触面积,加强密封效果,防止内漏。The present invention proposes a branch covered stent. The main covered stent is designed with an adjustable round platform on the pre-opened hole. The small ring of the round platform is connected with the pre-opened hole by the covered film and moved in an appropriate amount to adapt to the anatomical structure of different branch vessels. When the branch covered stent of the present invention is used in conjunction with the main body covered stent, the frustum-shaped connection anchoring section and the frustum-shaped adjusting round table are adapted to each other, increasing the contact area, strengthening the sealing effect, and preventing internal leakage.
本发明提出一种分支覆膜支架,当主体覆膜支架的调节圆台可成倒扣圆台型,本发明中的连接锚固段与调节圆台适配时,可产生“卡扣”考过,连接更稳固,密封性更好,即本发明所述分支覆膜支架的圆台型连接锚固段与调节圆台的接触面大,摩擦大,密封精密,甚至会产生卡扣效果,其对主体覆膜支架的稳固效果和自身的锚固效果较好。The present invention proposes a branch film-covered stent. When the adjustment round table of the main body film-covered support can be turned into an inverted round table, when the connecting anchor section in the present invention is adapted to the adjustment round table, a "snapping" can occur, and the connection is more accurate. Stable and better sealing, that is, the contact surface between the conical connecting anchor section of the branch stent-graft and the adjusting circular pedestal is large, the friction is large, the sealing is precise, and even a buckle effect will be produced, which has a great impact on the main body of the stent-graft. The stabilization effect and its own anchoring effect are better.
本发明提出一种分支覆膜支架,具有支架支撑段和支架缩径段,其依靠支架支撑段支撑锚固在血管中,而当其弯曲时,由于支架缩径段直径较小,由弯曲产生的锐利峰角不易触碰到血管内壁,划伤血管,从而保证其安全性。The present invention proposes a branch covered stent, which has a stent support section and a stent narrowing section, which is supported and anchored in the blood vessel by the stent support section. The sharp peak angle is not easy to touch the inner wall of the blood vessel and scratch the blood vessel, thus ensuring its safety.
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,下面将对实施例描述所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following will briefly introduce the accompanying drawings that are required for the description of the embodiments. Obviously, the accompanying drawings in the following description are only some embodiments of the present invention. Those of ordinary skill in the art can also obtain other drawings based on these drawings without any creative effort.
图1为本发明于一实施例中分支覆膜支架的结构示意图。FIG. 1 is a schematic structural view of a branched stent graft in an embodiment of the present invention.
图2为本发明于一实施例中分支覆膜支架轴侧的结构示意图。Fig. 2 is a schematic structural view of the axial side of a branched stent graft in an embodiment of the present invention.
图3为本发明于一实施例中分支覆膜支架中支撑框架的结构示意图。FIG. 3 is a schematic structural view of a supporting frame in a branched stent graft in an embodiment of the present invention.
图4为本发明于另一实施例中分支覆膜支架中支撑框架的结构示意图。Fig. 4 is a schematic structural view of a supporting frame in a branched stent graft in another embodiment of the present invention.
图5为本发明于一实施例中分支覆膜支架中支架支撑段的结构示意图。Fig. 5 is a schematic structural view of a stent support section in a branched stent graft in an embodiment of the present invention.
图6为本发明于一实施例中分支覆膜支架中支架缩径段的结构示意图。FIG. 6 is a schematic structural view of a narrowing section of a branched stent graft in an embodiment of the present invention.
图7为本发明于一实施例中分支覆膜支架植入分支血管的示意图。FIG. 7 is a schematic diagram of implanting a branched stent graft into a branch vessel in an embodiment of the present invention.
图8为本发明于一实施例中分支覆膜支架中连接锚固段的结构示意图。Fig. 8 is a schematic diagram of the structure of the connecting anchoring section in the branched stent graft in an embodiment of the present invention.
图9为本发明于另一实施例中分支覆膜支架中连接锚固段的结构示意图。Fig. 9 is a schematic structural view of the connecting anchoring section in the branched stent graft in another embodiment of the present invention.
图10为本发明于另一实施例中分支覆膜支架植入分支血管的示意图。FIG. 10 is a schematic diagram of implanting a branched stent graft into a branch vessel in another embodiment of the present invention.
标号说明:Label description:
分支覆膜支架1;支撑框架11;覆膜12;支架支撑段A;支架缩径段B;连接锚固段C;近心端D;远心端E;覆膜附着区Aa;支架裸露区Ab;变径区Ba;小径区Bb;分支血管401。Branch covered
具体实施方式Detailed ways
以下通过特定的具体实例说明本发明的实施方式,本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用,本说明书中的各项细节也可以基于不同观点与应用,在没有背离本发明的精神下进行各种修饰或改变。Embodiments of the present invention are described below through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific implementation modes, and various modifications or changes can be made to the details in this specification based on different viewpoints and applications without departing from the spirit of the present invention.
需要说明的是,本实施例中所提供的图示仅以示意方式说明本发明的基本构想,遂图式中仅显示与本发明中有关的组件而非按照实际实施时的组件数目、形状及尺寸绘制,其实际实施时各组件的型态、数量及比例可为一种随意的改变,且其组件布局型态也可能更为复杂。It should be noted that the diagrams provided in this embodiment are only schematically illustrating the basic idea of the present invention, and only the components related to the present invention are shown in the diagrams rather than the number, shape and shape of the components in actual implementation. Dimensional drawing, the type, quantity and proportion of each component can be changed arbitrarily during actual implementation, and the component layout type may also be more complicated.
为了便于描述,对文中出现的专业术语进行解释:For the convenience of description, the technical terms appearing in the text are explained:
近心端:从心脏发出的动脉血管逐渐分支成毛细血管,再逐渐汇集成静脉血管回到心脏,其中任何一段血管,离心脏近的一端就称为近心端。Proximal end: The arterial vessels from the heart gradually branch into capillaries, and then gradually converge into venous vessels to return to the heart. The end of any section of blood vessels that is closest to the heart is called the proximal end.
远心端:从心脏发出的动脉血管逐渐分支成毛细血管,再逐渐汇集成静脉血管回到心脏,其中任何一段血管,离心脏远的一端就称为远心端。Distal end: The arterial vessels from the heart gradually branch into capillaries, and then gradually converge into venous vessels to return to the heart. Any section of blood vessels that is far away from the heart is called the distal end.
轴向:血管、介入支架等均为类圆管状,若将其看作圆柱体,则定义其圆柱体旋转轴为轴向。本发明的描述中,若未进行特别限定,覆膜支架的轴向是指主通道的轴向。Axial: Blood vessels, interventional stents, etc. are all in the shape of a round tube. If they are regarded as cylinders, the axis of rotation of the cylinder is defined as the axial direction. In the description of the present invention, unless otherwise specified, the axial direction of the stent-graft refers to the axial direction of the main channel.
径向:“径向”垂直于“轴向”,即圆柱体端面圆的半径或直径方向,径向与轴向空间垂直。本发明的描述中,若未进行特别限定,覆膜支架的径向是指主通道的径向。Radial: "radial" is perpendicular to "axial", that is, the radius or diameter direction of the end face circle of a cylinder, and the radial direction is perpendicular to the axial space. In the description of the present invention, unless otherwise specified, the radial direction of the stent-graft refers to the radial direction of the main channel.
周向:“周向”即圆周方向,其与“轴向”和“径向”共同组成柱坐标的三个正交方向。本发明的描述中,若未进行特别限定,覆膜支架的周向是指主通道的周向。Circumferential direction: "Circumferential direction" refers to the circumferential direction, which together with "axial" and "radial" constitute three orthogonal directions of cylindrical coordinates. In the description of the present invention, unless otherwise specified, the circumferential direction of the stent graft refers to the circumferential direction of the main channel.
如图1所示,在本实施例中,本发明提出一种分支覆膜支架,图1展示了该分支覆膜支架的一示例性的结构示意图,所述分支覆膜支架1包括支撑框架11和覆膜12,所述覆膜12附着在所述支撑框架11上,所述支撑框架11是所述分支覆膜支架1的结构框架,所述支撑框架11的形状决定了所述分支覆膜支架1的整体形状,具体的,所述分支覆膜支架1包括依次设置的支架支撑段A、支架缩径段B和连接锚固段C,即所述支架支撑段A和所述连接锚固段C位于所述支架缩径段B的两端,所述支架缩径段B与所述连接锚固段C连接的一端的直径小于所述支架支撑段A的直径,且所述连接锚固段C远离与所述支架缩径段B连接的一端的直径大于所述支架支撑段A的直径。As shown in FIG. 1 , in this embodiment, the present invention proposes a branched stent-graft. FIG. 1 shows an exemplary structural diagram of the branched stent-graft. The branched stent-
如图1至图3所示,在本实施例中,所述支撑框架11由一根或若干根金属丝缠绕弯曲制成,其横截面为圆形,且所述支撑框架11的任一圈呈波浪状,具体的,所述支撑框架11其由一根或若干根金属丝在定制模具上缠绕弯曲若干圈,再热处理定型而制成,即其所有的波浪框架是相连的,且所述支撑框架11的任一圈框架呈波浪起伏状,且每一圈框架的波峰或波谷的数量至少为三个。在本实施例中,所述支撑框架11上相邻的两圈框架之间的距离h1设置在3mm至20mm之间。As shown in Figures 1 to 3, in this embodiment, the
如图1、图2及图4所示,在一些其他实施例中,所述支撑框架11包括多个独立的金属丝圆环沿轴向排列形成,且每个独立的所述圆环在周向上呈波浪状,同样的,每个波浪状的圆环的波峰或波谷的数量至少为三个。同样的,在本实施例中,所述支撑框架11上相邻的两个独立的圆环之间的距离设置在3mm至20mm之间。As shown in Figure 1, Figure 2 and Figure 4, in some other embodiments, the
需要说明的是,如图1至图4所示,在本实施例中,该支撑框架11由一根或若干根金属丝缠绕弯曲制成或由多个独立的圆环上的每个所述波浪状的在轴向上波峰至波谷之间的距离设置在3mm至15mm之间,同时,所述金属丝的横截面为圆形或正方形,其圆形的直径或正方形外接圆的直径设置在0.1mm至1mm之间,例如金属丝直径可以是0.1mm、0.2mm、0.5mm、0.6mm、0.8mm、1mm等。在一些其他实施例中,所述支撑框架11为切割支架,即采用激光切割金属管材,再通过扩径、外翻、热处理定型等工艺制作而成或由3D金属打印技术制作而成。It should be noted that, as shown in Fig. 1 to Fig. 4, in this embodiment, the
需要说明的是,如图1及图2所示,所述覆膜12通过缝合或热熔的方式附着在所述支撑框架11表面上,且所述覆膜12为柔性薄膜,其可由聚氨基甲酸乙酯、PET(Polyethyleneterephthalate,聚酯纤维、涤纶)或EPTFE(expanded,膨体聚四氟乙烯)等材料制作而成。It should be noted that, as shown in Figures 1 and 2, the covering
需要说明的是,如图1及图2所示,所述覆膜12是分支覆膜支架1的连接组件,其主要功能之一是连接所述支撑框架11,同时,覆膜12由柔性材料制作而成,使得所述分支覆膜支架1具有较强的弯曲性能和柔顺性能,可以保证所述分支覆膜支架1可以在弯曲的血管内输送,并适应介入血管的弯曲结构。It should be noted that, as shown in Figures 1 and 2, the
需要说明的是,如图1及图2所示,覆膜12还具有密封的功能,即当分支覆膜支架1介入病变血管之后,覆膜12覆盖住病变区域,不仅能封闭破口,而且保证血液不渗透。It should be noted that, as shown in Figures 1 and 2, the covering
为便于说明,如图1、图2及图7所示,根据所述分支覆膜支架1介入分支血管401的方位,对分支覆膜支架1的两端进行定义,在以下描述中,将分支覆膜支架1的一端定义为近心端D,将另一端定义为远心端E。For the convenience of explanation, as shown in Fig. 1, Fig. 2 and Fig. 7, the two ends of the branch stent-
如图1及图5所示,在本实施例中,所述分支覆膜支架1包括依次设置的支架支撑段A、支架缩径段B和连接锚固段C,即所述分支覆膜支架1沿着所述远心端E指向所述近心端D的方向依次分为所述支架支撑段A、支架缩径段B和连接锚固段C,所述分支覆膜支架1通过所述支架支撑段A支撑锚固在血管中,所述支架缩径段B用于避免弯曲产生的锐利峰角划伤血管,所述连接锚固段C用于配合连接主体覆膜支架。As shown in Figures 1 and 5, in this embodiment, the branched stent-
如图1及图5所示,在本实施例中,所述支架支撑段A位于所述分支覆膜支架1的远心端E的一侧,且所述支架支撑段A在轴向上下等径,即所述支架支撑段A的直径相同,例如设置在10mm至20mm之间,所述支架支撑段A的支撑框架11可由一根或若干根金属丝缠绕弯曲制成或由多个独立的圆环排列形成。当所述分支覆膜支架1输送至血管中后其依靠支架支撑段A支撑锚固在血管中。As shown in Fig. 1 and Fig. 5, in this embodiment, the stent support section A is located on one side of the distal end E of the
如图1及图5所示,在本实施例中,所述支架支撑段A包括覆膜附着区Aa和支架裸露区Ab,所述支架裸露区Ab位于所述覆膜附着区Aa远离所述支架缩径段B一端,覆膜附着区Aa由部分支撑框架11表面附着12覆膜形成,支架裸露区Ab是支撑框架11的远心端E的若干裸露波峰,该区域的表面不附着覆膜12,且支架裸露区Ab的高度例如设置在0.5mm至5mm支架,支架裸露区Ab可与定制输送系统搭配使用,以牵拉移动所述分支覆膜支架1。As shown in Fig. 1 and Fig. 5, in this embodiment, the stent supporting section A includes a membrane attachment area Aa and a stent bare area Ab, and the stent bare area Ab is located far from the membrane attachment area Aa. At one end of the narrowing section B of the stent, the film attachment area Aa is formed by part of the surface of the
如图1及图6所示,在本实施例中,所述支架缩径段B位于所述分支覆膜支架1的中部,所述支架缩径段B在轴向上下变径,且所述支架缩径段B表面无裸露区域,均附着有覆膜12。所述支架缩径段B包括变径区Ba和小径区Bb,所述变径区Ba位于所述支架支撑段A和所述小径区Bb之间,所述变径区Ba在轴向上的高度设置在5mm至10mm之间,所述小径区Bb在轴向上的高度设置在5mm至20mm之间。As shown in Figure 1 and Figure 6, in this embodiment, the stent diameter reducing section B is located in the middle of the branch covered
如图1及图6所示,在本实施例中,所述变径区Ba位于支架缩径段B靠近远心端E的一侧,在轴向上下变径,呈倒扣的空心圆台状,具体的,所述变径区Ba的直径沿着所述支架支撑段A指向所述连接锚固段C的方向逐渐减小,且所述变径区Ba远离所述支架支撑段A的一端的直径设置在5mm至15mm之间,即所述变径区Ba的直径沿着所述远心端E指向所述近心端D的方向逐渐减小,Ba变径区靠近所述远心端E的一端的直径与支架支撑段A的直径相同,变径区Ba靠近所述近心端D的一端的直径设置在5mm至15mm之间。As shown in Fig. 1 and Fig. 6, in this embodiment, the diameter reducing area Ba is located on the side of the stent reducing section B close to the distal end E, and changes in diameter up and down in the axial direction, in the shape of an inverted hollow truncated cone Specifically, the diameter of the diameter-reducing area Ba gradually decreases along the direction in which the stent support segment A points to the connecting anchor segment C, and the diameter-reduction area Ba is far away from the end of the stent support segment A. The diameter is set between 5 mm and 15 mm, that is, the diameter of the variable diameter area Ba gradually decreases along the direction from the distal end E to the proximal end D, and the Ba variable diameter area is close to the distal end E The diameter of one end of the stent is the same as that of the stent support section A, and the diameter of the end of the tapering area Ba close to the proximal end D is set between 5mm and 15mm.
如图1及图6所示,在本实施例中,小径区Bb位于支架缩径段B靠近近心端D的一侧,在轴向上下等径或微量变径,呈空心圆柱状或倒扣的空心圆台状,具体的,所述小径区Bb沿其轴向的直径不变,或者,小径区Bb的直径沿着所述支架支撑段A向所述连接锚固段C方向逐渐减小,且所述小径区Bb远离所述变径区Ba的直径小于靠近所述变径区Ba一端的直径1mm至2mm,即所述小径区Bb的直径沿着所述远心端E指向所述近心端D的方向不变或逐渐减小;当小径区Bb上下直径不变时,小径区Bb的直径与变径区Ba靠近近心端D一端的直径相同;当小径区Bb上下变径时,小径区Bb的靠近近心端D的一端的直径小于其靠近远心端E的一端的直径1-2mm。当分支覆膜支架1在弯曲时,由于支架缩径段B直径较小,由弯曲产生的锐利峰角不易触碰到血管内壁,从而避免划伤血管。As shown in Figures 1 and 6, in this embodiment, the small-diameter area Bb is located on the side of the narrowing section B of the stent close to the proximal end D, and is equal in diameter up and down in the axial direction or slightly reduced in diameter, and is in the shape of a hollow cylinder or an inverted In particular, the diameter of the small-diameter area Bb along its axial direction is constant, or the diameter of the small-diameter area Bb gradually decreases along the support section A of the stent to the direction of the connecting anchor section C, And the diameter of the small-diameter area Bb away from the variable-diameter area Ba is smaller than the diameter near the end of the variable-diameter area Ba by 1 mm to 2 mm, that is, the diameter of the small-diameter area Bb points along the distal end E to the near The direction of the central end D remains unchanged or gradually decreases; when the upper and lower diameters of the small diameter area Bb are constant, the diameter of the small diameter area Bb is the same as the diameter of the diameter-changing area Ba near the proximal end D; when the small-diameter area Bb changes in diameter up and down , the diameter of the end near the proximal end D of the small diameter area Bb is smaller than the diameter of the end near the distal end E by 1-2 mm. When the branched stent-
传统分支覆膜支架在植入血管后,由于分支血管分叉角度多变,分支覆膜支架无法适配各种弯曲形态的分支血管,异常弯曲的分支覆膜支架易形成锐角,划伤分支血管内壁,即由于传统分支覆膜支架无支架缩径段,整体在轴向上下等径,呈空心圆柱状,当传统分支覆膜支架植入弯曲的分支血管后,传统分支覆膜支架需随着血管发生弯曲,此时及易产生锐利的峰角,划伤血管内壁。After the traditional branch stent-graft is implanted into the blood vessel, due to the changeable bifurcation angle of the branch vessel, the branch-covered stent-graft cannot adapt to various curved branch vessels, and the abnormally curved branch-covered stent-graft is easy to form an acute angle and scratch the branch vessel The inner wall, that is, because the traditional branched stent-graft has no stent-reducing section, the overall diameter is equal up and down in the axial direction, and it is hollow cylindrical. When the traditional branched stent-graft is implanted into a curved branch vessel, the traditional branched stent-graft needs to follow When the blood vessel bends, it is easy to produce a sharp peak angle at this time, scratching the inner wall of the blood vessel.
如图7所示,在本实施例中,所述分支覆膜支架1具有支架支撑段A和支架缩径段B,其依靠支架支撑段A支撑锚固在分支血管401中,而当其弯曲时,由于支架缩径段B直径较小,由弯曲产生的锐利峰角不易触碰到血管内壁,从而避免划伤血管。As shown in Figure 7, in this embodiment, the
如图1所示,在本实施例中,连接锚固段C位于分支覆膜支架1靠近所述近心端D的一侧,连接锚固段C在轴向上下变径,呈空心圆台状,具体的,所述连接锚固段C的直径沿着远离与所述支架缩径段B连接的一端的方向逐渐增大,所述连接锚固段C远离与所述支架缩径段B连接的一端的直径设置在10mm至25mm之间。As shown in Figure 1, in this embodiment, the connecting anchoring section C is located on the side of the
如图1及图8所示,在本实施例中,所述连接锚固段C远离所述支架缩径段B一端的支撑框架11周向上呈波浪状,所述覆膜12沿着所述波浪状的波峰连接,使所述连接锚固段C呈圆台状,或沿着呈所述波浪状的金属丝连接,使所述连接锚固段C呈花瓣状。As shown in Figures 1 and 8, in this embodiment, the
本发明所述的分支覆膜支架1与预开窗式主体覆膜支架搭配使用时,适配形态较佳,本发明所述的分支覆膜支架发生连接处内漏的可能性更低,具体的,主体覆膜支架在预开孔上设计了一个调节圆台,圆台的小环依靠覆膜与预开孔相连,并适量移动,以适应不同分支血管解剖结构,当本发明所述分支覆膜支架与该种主体覆膜支架搭配使用时,圆台型的连接锚固段与圆台型的调节圆台相互适配,增加接触面积,加强密封效果,防止内漏。When the branch stent-
如图9所示,在一些其他实施例中,所述连接锚固段C的一端与所述支架缩径段B连接,另一端朝向所述支架支撑段A的方向向外翻折,使所述连接锚固段C呈倒圆台状。As shown in Figure 9, in some other embodiments, one end of the connecting anchor section C is connected to the narrowing section B of the stent, and the other end is turned outward toward the direction of the support section A of the stent, so that the The connecting anchor segment C is in the shape of a rounded platform.
当与传统预开窗式主体覆膜支架搭配使用时,本发明所述的分支覆膜支架发生连接处内漏的可能性更低,具体的,传统分支覆膜支架的连接锚固段为类似“飞碟”型的直段,当传统主体覆膜支架植入弯曲的主动脉弓后,传统主体覆膜支架会随着血管的形态发生弯曲,当传统分支覆膜支架穿过预开孔,植入分支血管,并连接传统主体覆膜支架后,“飞碟”形的直形锚固连接段与弯曲的传统主体覆膜支架适配形态不佳,连接锚固段的边缘易产生微小间隙,引发内漏。When used in conjunction with the traditional pre-opened fenestrated stent-graft, the branched stent-graft of the present invention is less likely to leak at the joint. Specifically, the connection anchoring section of the traditional branched stent-graft is similar to " UFO-shaped straight section, when the traditional main body covered stent graft is implanted into the curved aortic arch, the traditional main body covered stent graft will bend with the shape of the blood vessel, when the traditional branch covered stent graft passes through the pre-opened hole, the branch blood vessel will be implanted , and after connecting the traditional main body covered stent, the "flying saucer"-shaped straight anchoring connection section and the curved traditional main body covered stent do not fit well, and small gaps are likely to occur at the edge of the connecting anchor section, causing endoleaks.
如图9及图10所示,在本实施例中,本发明中的所述分支覆膜支架1植入弯曲的主动脉弓后,“倒扣圆台”型的连接锚固段必会有一段直径和预开孔直径相同,所以连接锚固段可以更紧密的贴合预开孔,完成密封,防止内漏。As shown in Figures 9 and 10, in this embodiment, after the
本发明提出一种分支覆膜支架,当所述分支覆膜支架植入弯曲的主动脉弓后,所述连接锚固段必会有一段直径和预开孔直径相同,所以连接锚固段可以更紧密的贴合预开孔,完成密封,防止内漏。The present invention proposes a branched stent graft. When the branched stent graft is implanted into a curved aortic arch, the connecting anchoring section must have a section with the same diameter as the pre-opening hole, so the connecting anchoring section can be more tightly attached. Combined with pre-opening holes to complete the seal and prevent internal leakage.
本发明提出一种分支覆膜支架,主体覆膜支架在预开孔上设计了一个调节圆台,圆台的小环依靠覆膜与预开孔相连,并适量移动,以适应不同分支血管解剖结构,当本发明所述分支覆膜支架与该主体覆膜支架搭配使用时,圆台型的连接锚固段与圆台型的调节圆台相互适配,增加接触面积,加强密封效果,防止内漏。The present invention proposes a branch covered stent. The main covered stent is designed with an adjustable round platform on the pre-opened hole. The small ring of the round platform is connected with the pre-opened hole by the covered film and moved in an appropriate amount to adapt to the anatomical structure of different branch vessels. When the branch covered stent of the present invention is used in conjunction with the main body covered stent, the frustum-shaped connection anchoring section and the frustum-shaped adjusting round table are adapted to each other, increasing the contact area, strengthening the sealing effect, and preventing internal leakage.
本发明提出一种分支覆膜支架,当主体覆膜支架的调节圆台可成倒扣圆台型,本发明中的连接锚固段与调节圆台适配时,可产生“卡扣”考过,连接更稳固,密封性更好,即本发明所述分支覆膜支架的圆台型连接锚固段与调节圆台的接触面大,摩擦大,密封精密,甚至会产生卡扣效果,其对主体覆膜支架的稳固效果和自身的锚固效果较好。The present invention proposes a branch film-covered stent. When the adjustment round table of the main body film-covered support can be turned into an inverted round table, when the connecting anchor section in the present invention is adapted to the adjustment round table, a "snapping" can occur, and the connection is more accurate. Stable and better sealing, that is, the contact surface between the conical connecting anchor section of the branch stent-graft and the adjusting circular pedestal is large, the friction is large, the sealing is precise, and even a buckle effect will be produced, which has a great impact on the main body of the stent-graft. The stabilization effect and its own anchoring effect are better.
本发明提出一种分支覆膜支架,具有支架支撑段和支架缩径段,其依靠支架支撑段支撑锚固在血管中,而当其弯曲时,由于支架缩径段直径较小,由弯曲产生的锐利峰角不易触碰到血管内壁,划伤血管,从而保证其安全性。The present invention proposes a branch covered stent, which has a stent support section and a stent narrowing section, which is supported and anchored in the blood vessel by the stent support section. The sharp peak angle is not easy to touch the inner wall of the blood vessel and scratch the blood vessel, thus ensuring its safety.
以上描述仅为本申请的较佳实施例以及对所运用技术原理的说明,本领域技术人员应当理解,本申请中所涉及的范围,并不限于上述技术特征的特定组合而成的技术方案,同时也应涵盖在不脱离所述发明构思的情况下,由上述技术特征或其等同特征进行任意组合而形成的其它技术方案,例如上述特征与本申请中公开的(但不限于)具有类似功能的技术特征进行互相替换而形成的技术方案。The above description is only a preferred embodiment of the application and an explanation of the technical principle used. Those skilled in the art should understand that the scope involved in this application is not limited to the technical solution formed by the specific combination of the above technical features. At the same time, it should also cover other technical solutions formed by any combination of the above-mentioned technical features or their equivalent features without departing from the inventive concept, for example, the above-mentioned features have similar functions to those disclosed in this application (but not limited to) A technical solution formed by replacing each other's technical features.
除说明书所述的技术特征外,其余技术特征为本领域技术人员的已知技术,为突出本发明的创新特点,其余技术特征在此不再赘述。Except for the technical features described in the specification, the rest of the technical features are known to those skilled in the art. In order to highlight the innovative features of the present invention, the rest of the technical features will not be repeated here.
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