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CN116407330A - Lumen stent - Google Patents

Lumen stent Download PDF

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Publication number
CN116407330A
CN116407330A CN202111668360.5A CN202111668360A CN116407330A CN 116407330 A CN116407330 A CN 116407330A CN 202111668360 A CN202111668360 A CN 202111668360A CN 116407330 A CN116407330 A CN 116407330A
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section
side wall
exoskeleton
stent
wave
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郑灏星
肖本好
刘宗麟
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Lifetech Scientific Shenzhen Co Ltd
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Lifetech Scientific Shenzhen Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

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  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The present invention relates to a lumen stent. The lumen stent comprises a tubular main body and a coating, wherein the tubular main body comprises an inner framework and an outer framework, the coating is arranged on the inner framework, the outer framework is sleeved on the inner hanging frame, and the outer framework is used for forming a protective layer on the outer side of the coating. Therefore, the outer framework is sleeved on the inner framework, so that the outer framework is positioned at the outer side of the tectorial membrane, and when the main support rubs with the lumen support, the outer framework can form a barrier at the outer side of the tectorial membrane to prevent the friction between the main support and the tectorial membrane, thereby realizing the protection of the tectorial membrane.

Description

管腔支架Endoluminal stent

技术领域technical field

本发明涉及医疗器械领域,特别是涉及一种管腔支架。The invention relates to the field of medical instruments, in particular to a lumen support.

背景技术Background technique

本部分提供的仅仅是与本公开相关的背景信息,其并不必然是现有技术。This section provides background information related to the present disclosure only and is not necessarily prior art.

主动脉瘤腔内修复术(Endovascular aortic repair.EVAR),因具有操作简单、创伤小、手术时间短等优点而得到广泛的临床应用,现已逐渐成为治疗主动脉夹层的重要手段。Endovascular aortic repair (EVAR) has been widely used clinically due to its advantages of simple operation, less trauma, and shorter operation time, and has gradually become an important method for the treatment of aortic dissection.

如图1所示,当主动脉夹层发生于主动脉弓部时,为了在隔绝病变部位的基础上保障主动脉弓和弓上三分支血管的血液流通,通常采用主支架700和分支支架100配合的方式来实现上述效果,然而,在血液的周期性脉动压的反复作用下导致主支架700和分支支架100产生细微的晃动,从而使主支架700和分支支架100的侧壁相互摩擦而引起覆膜破裂,引起内漏。As shown in Figure 1, when aortic dissection occurs in the aortic arch, in order to ensure the blood circulation of the aortic arch and the three branch vessels on the basis of isolating the lesion, the main stent 700 and the branch stent 100 are usually used to achieve the above. However, under the repeated action of the periodic pulsating pressure of the blood, the main stent 700 and the branch stent 100 will produce slight shaking, so that the side walls of the main stent 700 and the branch stent 100 will rub against each other, causing the membrane to rupture, causing endovascular leak.

发明内容Contents of the invention

基于此,有必要提供一种管腔支架,包括管状主体和覆膜,管状主体包括内骨架和外骨架,覆膜设置于内骨架上,外骨架套设于内挂架上,外骨架用于在覆膜的外侧形成防护层。Based on this, it is necessary to provide a luminal stent, including a tubular body and a membrane. The tubular body includes an inner skeleton and an outer skeleton. A protective layer is formed on the outside of the film.

可选地,外骨架呈网状结构,外骨架包括第一侧壁和第二侧壁,当外骨架处于自然状态时,第一侧壁上最小的网孔面积小于第二侧壁上的最小的网孔面积,当外骨架处于弯曲状态时,第一侧壁为大弯侧,第二侧壁为小弯侧。Optionally, the exoskeleton has a network structure, and the exoskeleton includes a first side wall and a second side wall. When the exoskeleton is in a natural state, the smallest mesh area on the first side wall is smaller than the smallest mesh area on the second side wall. The mesh area of , when the exoskeleton is in a curved state, the first side wall is a large curved side, and the second side wall is a small curved side.

可选地,第二侧壁与内骨架连接,第一侧壁的至少一处悬浮形成自由端。Optionally, the second side wall is connected to the inner frame, and at least one part of the first side wall is suspended to form a free end.

可选地,外骨架由编织丝编织形成,第一侧壁上的编织丝相互勾挂,第二侧壁上的编织丝形成轴向上两个相邻的波峰和波谷互不干涉。Optionally, the outer frame is formed by weaving braiding wires, the braiding wires on the first side wall are hooked to each other, and the braiding wires on the second side wall form two adjacent crests and troughs in the axial direction without interfering with each other.

可选地,内骨架包括依次连接的第一段、第二段和第三段,第二段位于第一段和第三段之间,且第二段的柔顺性大于第一段和第三段的柔顺性,外骨架覆盖第二段。Optionally, the inner frame includes a first segment, a second segment and a third segment connected in sequence, the second segment is located between the first segment and the third segment, and the flexibility of the second segment is greater than that of the first segment and the third segment segment compliance, the exoskeleton covers the second segment.

可选地,第二段包括多个波形环状物,多个波形环状物沿第二段的轴向间隔设置。Optionally, the second segment includes a plurality of wave-shaped rings, and the plurality of wave-shaped rings are arranged at intervals along the axial direction of the second segment.

可选地,波形环状物包括波峰和波谷,轴向相邻的两个波形环状物上的波峰位于同一直线上,轴向相邻的两个波形环状物的波谷位于同一直线上。Optionally, the wave-shaped rings include crests and troughs, the peaks of two axially adjacent wave-shaped rings are located on the same straight line, and the wave-shaped rings of two axially adjacent wave-shaped rings are located on the same straight line.

可选地,外骨架由编织丝编织形成,外骨架上的编织丝的交点位于第二段上轴向相邻的两个波形环状物之间。Optionally, the outer frame is formed by braiding wires, and the intersection point of the braiding wires on the outer frame is located between two axially adjacent wave-shaped rings on the second section.

可选地,第一段、外骨架和第三段一体编织形成,第一段、第三段的外径小于外骨架的外径。Optionally, the first section, the outer skeleton and the third section are integrally braided, and the outer diameters of the first section and the third section are smaller than the outer diameter of the outer skeleton.

可选地,管腔支架还包括两个显影结构,两个显影结构分别设置于第二段的两端。Optionally, the lumen stent further includes two developing structures, and the two developing structures are respectively arranged at both ends of the second section.

本发明还提供一种支架系统,包括如上的管腔支架,还包括主支架,主支架上开设有通孔,管腔支架插设于通孔内且至少部分位于主支架的外侧。The present invention also provides a stent system, including the luminal stent as above, and a main stent, the main stent is provided with a through hole, and the luminal stent is inserted in the through hole and at least partly located outside the main stent.

与现有技术相比,本发明所述的管腔支架及支架系统具有的有益效果是:Compared with the prior art, the beneficial effects of the luminal stent and the stent system of the present invention are:

本发明通过通过覆膜设置于内骨架上,使内骨架与覆膜配合形成密封通道,通过外骨架套设于内骨架上,使外骨架位于覆膜的外侧,当主支架与管腔支架摩擦时,尤其是在相邻的两个波形环状物之间的间隙处,由于覆膜没有支撑,在该区域,覆膜容易受到主支架的摩擦而破损,这时,外骨架可以在覆膜的外侧形成阻隔,防止主支架与覆膜产生摩擦,从而实现了对覆膜的保护。In the present invention, the coating is arranged on the inner frame, so that the inner frame cooperates with the coating to form a sealed channel, and the outer frame is sleeved on the inner frame, so that the outer frame is located outside the coating. When the main bracket and the lumen bracket are rubbed , especially at the gap between two adjacent wave-shaped rings, since the membrane is not supported, in this area, the membrane is easily damaged by the friction of the main bracket. At this time, the exoskeleton can be A barrier is formed on the outside to prevent friction between the main support and the covering film, thus realizing the protection of the covering film.

附图说明Description of drawings

图1为现有技术中主支架与分支支架在血管内的配合示意图;Fig. 1 is a schematic diagram of the cooperation of the main stent and the branch stent in the blood vessel in the prior art;

图2为本发明的实施例一中的管腔支架的结构示意图;2 is a schematic structural view of the lumen stent in Embodiment 1 of the present invention;

图3为本发明的实施例一中的管腔支架的爆炸结构示意图;3 is a schematic diagram of the exploded structure of the lumen stent in Embodiment 1 of the present invention;

图4为本发明的实施例一中的管腔支架的另一结构示意图;Fig. 4 is another structural schematic diagram of the lumen stent in Embodiment 1 of the present invention;

图5为本发明的实施例一中的内骨架、外骨架呈网状结构的爆炸示意图;Fig. 5 is a schematic exploded view of the inner skeleton and the outer skeleton in a network structure in Embodiment 1 of the present invention;

图6为本发明的实施例二中的管腔支架的结构示意图;6 is a schematic structural view of the lumen stent in Embodiment 2 of the present invention;

图7为本发明的实施例二中的管腔支架的爆炸示意图;FIG. 7 is a schematic exploded view of the lumen stent in Embodiment 2 of the present invention;

图8为本发明的实施例二中的第一段、外骨架和第三段的展开结构示意图;Fig. 8 is a schematic diagram of the unfolded structure of the first section, the exoskeleton and the third section in Embodiment 2 of the present invention;

图9为本发明的实施例二中的外骨架的展开结构示意图;9 is a schematic diagram of the expanded structure of the exoskeleton in Embodiment 2 of the present invention;

图10为本发明的实施例二中的外骨架处于弯曲状态下的结构示意图;Fig. 10 is a schematic structural view of the exoskeleton in a bent state in Embodiment 2 of the present invention;

图11为本发明的实施例二中的第二侧壁上的网孔变形示意图;Fig. 11 is a schematic diagram of mesh deformation on the second side wall in Embodiment 2 of the present invention;

图12为本发明的实施例二中的第一侧壁上的网孔变形示意图;Fig. 12 is a schematic diagram of mesh deformation on the first side wall in Embodiment 2 of the present invention;

图13为本发明的图8中的A处结构放大示意图;Fig. 13 is an enlarged schematic diagram of the structure at A in Fig. 8 of the present invention;

图14为本发明的图9中的B处结构放大示意图;Fig. 14 is an enlarged schematic diagram of the structure at B in Fig. 9 of the present invention;

图15为本发明的图9中的C处结构放大示意图;Fig. 15 is an enlarged schematic diagram of the structure at C in Fig. 9 of the present invention;

图16为本发明的实施二中的覆膜与管状主体连接后的展开示意图;Fig. 16 is a schematic diagram of unfolding after the membrane is connected to the tubular body in Embodiment 2 of the present invention;

图17为本发明的实施例三中的内骨架的结构示意图;Figure 17 is a schematic structural view of the inner skeleton in Embodiment 3 of the present invention;

图18为本发明的实施例四中的管腔支架与主支架的配合结构示意图。Fig. 18 is a schematic diagram of the cooperative structure of the endoluminal stent and the main stent in Embodiment 4 of the present invention.

具体实施方式Detailed ways

为使本发明的上述目的、特征和优点能够更加明显易懂,下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施,本领域技术人员可以在不违背本发明内涵的情况下做类似改进,因此本发明不受下面公开的具体实施的限制。In order to make the above objects, features and advantages of the present invention more comprehensible, specific implementations of the present invention will be described in detail below in conjunction with the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, the present invention can be implemented in many other ways different from those described here, and those skilled in the art can make similar improvements without departing from the connotation of the present invention, so the present invention is not limited by the specific implementations disclosed below.

除非另有定义,本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的,不是旨在于限制本发明。Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field of the invention. The terms used herein in the description of the present invention are for the purpose of describing specific embodiments only, and are not intended to limit the present invention.

实施例一Embodiment one

本实施例提供一种管腔支架,如图2、图3所示,该管腔支架包括管状主体和覆膜130,管状主体包括内骨架110和套设于内骨架110上的外骨架120,覆膜130设置于内骨架110上,外骨架120用于在覆膜130的外侧形成防护层。This embodiment provides a lumen stent, as shown in Figure 2 and Figure 3, the lumen stent includes a tubular body and a membrane 130, the tubular body includes an inner skeleton 110 and an outer skeleton 120 sleeved on the inner skeleton 110, The covering film 130 is disposed on the inner frame 110 , and the outer frame 120 is used to form a protective layer outside the covering film 130 .

值得说明的是,本实施例中的管腔支架,可用于主动脉动弓部动脉瘤腔内治疗以及胸腹主动脉瘤的治疗。具体地,本实施例中的管腔支架可在烟囱技术中作为分支支架,例如,在一种实施方式中,管腔支架与主支架并列设置于动脉腔内,管腔支架远离动脉腔的一端与分支血管连通。在另一的实施中,管腔支架还可以在原位开窗技术中作为分支支架。在其它的实施例中,该官腔支架可以在任意需要多个支架配合使用的场景中。It is worth noting that the lumen stent in this embodiment can be used for endovascular treatment of aortic arch aneurysms and treatment of thoracoabdominal aortic aneurysms. Specifically, the lumen stent in this embodiment can be used as a branch stent in the chimney technique. For example, in one embodiment, the lumen stent and the main stent are arranged side by side in the arterial lumen, and the end of the lumen stent is far away from the arterial lumen communicate with branch vessels. In another implementation, the endoluminal stent can also be used as a branch stent in the in situ fenestration technique. In other embodiments, the organ cavity stent can be used in any scene where multiple stents are required to cooperate.

如图2、图3所示,管状主体包括内骨架110和外骨架120,外骨架120套设于内骨架110上。外骨架120和内骨架110可以相互勾挂、粘接或通过覆膜130连接。覆膜130包覆于内骨架110上以形成管腔结构,使内骨架110与覆膜130配合形成密封通道。可以理解的是,在一个实施例中,覆膜130还可以包覆于外骨架120上。可以理解的是,在另一个实施例中,在释放状态下,外骨架120的内径d1大于内骨架110的外径d2。在其它的实施例中,外骨架120的内径d1还可以等于活小于内骨架110的外径d2,即外骨架120具有一定的可变形性能以套设于内骨架110上。As shown in FIG. 2 and FIG. 3 , the tubular body includes an inner skeleton 110 and an outer skeleton 120 , and the outer skeleton 120 is sheathed on the inner skeleton 110 . The outer frame 120 and the inner frame 110 can be hooked, bonded or connected through the covering film 130 . The membrane 130 covers the inner framework 110 to form a lumen structure, and the inner framework 110 cooperates with the membrane 130 to form a sealed channel. It can be understood that, in an embodiment, the covering film 130 can also be wrapped on the outer frame 120 . It can be understood that, in another embodiment, in the released state, the inner diameter d1 of the outer skeleton 120 is greater than the outer diameter d2 of the inner skeleton 110 . In other embodiments, the inner diameter d1 of the outer frame 120 can also be equal to or smaller than the outer diameter d2 of the inner frame 110 , that is, the outer frame 120 has a certain deformability to be sleeved on the inner frame 110 .

覆膜130的材料可以为可降解材料或非可降解材料。例如,覆膜130的材料可以为聚四氟乙烯(PTFE)、聚对苯二甲酸乙二醇酯(PET)、聚氨基甲酸乙酯(PU)或可降解聚乳酸(PLA)等等。The material of the covering film 130 can be degradable material or non-degradable material. For example, the material of the covering film 130 may be polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), polyurethane (PU) or degradable polylactic acid (PLA) and the like.

在本实施例中,如图3所示,内骨架110包括多个波形环状物111,多个波形环状物111沿内骨架110的轴向间隔设置,覆膜130包覆于波形环状物111上以实现相邻的两个波形环状物111的连接。In this embodiment, as shown in FIG. 3 , the inner frame 110 includes a plurality of wave-shaped rings 111 arranged at intervals along the axial direction of the inner frame 110 , and the coating 130 covers the wave-shaped rings. Object 111 to realize the connection of two adjacent wave-shaped ring objects 111.

在本实施例中,如图2、图3所示,外骨架120呈网状结构且由编织丝编织形成,外骨架120位于内骨架110的外侧,外骨架120的轴向两端与内骨架110上的波形环状物111连接,例如,在一种实施方式中,通过连接膜131将外骨架120的轴向两端粘合于覆膜130上,从而实现外骨架120与内骨架110的连接。可以理解的是,在另一种实施方式中,在内骨架110轴向两端上的波形环状物111的波峰裸露,外骨架120勾挂于裸露的波峰上。可以理解的是,在其它的实施方式中,覆膜130包括内层覆膜和外层覆膜,内层覆膜与内骨架110的内侧壁连接,外层覆膜与内骨架110的外侧壁连接,外层覆膜上开设有缺口,外骨架120穿过该缺口与波形环状物111连接。In this embodiment, as shown in FIG. 2 and FIG. 3 , the outer skeleton 120 has a mesh structure and is formed by weaving braided wires. The outer skeleton 120 is located outside the inner skeleton 110 . 110 on the wave ring 111 connection, for example, in one embodiment, the axial ends of the outer skeleton 120 are bonded to the covering film 130 through the connecting film 131, so as to realize the connection between the outer skeleton 120 and the inner skeleton 110 connect. It can be understood that, in another embodiment, the crests of the wave-shaped ring 111 at both axial ends of the inner frame 110 are exposed, and the outer frame 120 is hooked on the exposed crests. It can be understood that, in other embodiments, the coating 130 includes an inner coating and an outer coating, the inner coating is connected to the inner side wall of the inner framework 110, and the outer coating is connected to the outer side wall of the inner framework 110. To connect, a gap is opened on the outer coating, and the outer skeleton 120 is connected to the wave-shaped ring 111 through the gap.

这样设置的好处在于,通过外骨架120套设于内骨架110上,使外骨架120位于覆膜130的外侧,当主支架700与管腔支架摩擦时,尤其是在相邻的两个波形环状物111之间的间隙处,由于覆膜130没有支撑,在该区域,覆膜130容易受到主支架700的摩擦而破损,这时,外骨架120可以在覆膜130的外侧形成阻隔,防止主支架700与覆膜130产生摩擦,从而实现了对覆膜130的保护。The advantage of this arrangement is that the outer skeleton 120 is sleeved on the inner skeleton 110, so that the outer skeleton 120 is located outside the membrane 130. When the main bracket 700 rubs against the endoluminal bracket, especially when the two adjacent wave-shaped rings In the gap between objects 111, since the coating 130 is not supported, in this area, the coating 130 is easily damaged by the friction of the main bracket 700. At this time, the outer skeleton 120 can form a barrier on the outside of the coating 130 to prevent the main The bracket 700 rubs against the covering film 130 , thereby realizing the protection of the covering film 130 .

可以理解的是,在另一实施例中,如图4所示,内骨架210还可以由金属切割形成,内骨架210呈弹簧螺旋状结构,外骨架220由编织丝编织形成网状结构,外骨架220通过连接膜231实现与内骨架210的连接,覆膜230包覆于内骨架210上。It can be understood that, in another embodiment, as shown in FIG. 4 , the inner skeleton 210 can also be formed by cutting metal, the inner skeleton 210 has a spring spiral structure, the outer skeleton 220 is braided by braided wire to form a mesh structure, and the outer The frame 220 is connected to the inner frame 210 through the connection film 231 , and the coating film 230 covers the inner frame 210 .

可以理解的是,在其它的实施例中,如图5所示,内骨架320包括至少一根编织丝,编织丝编织形成网状结构,覆膜330包覆于内骨架320上,外骨架310呈网状结构,外骨架310套设于内骨架320上,外骨架310与内骨架320连接。It can be understood that, in other embodiments, as shown in FIG. 5 , the inner skeleton 320 includes at least one braided wire, and the braided wire is braided to form a network structure, the coating 330 is wrapped on the inner skeleton 320 , and the outer skeleton 310 It has a network structure, the outer frame 310 is sleeved on the inner frame 320 , and the outer frame 310 is connected with the inner frame 320 .

实施例二Embodiment two

本实例与实施例一的区别在于,如图6至图9所示,外骨架420呈网状结构,外骨架420包括第一侧壁421和第二侧壁422,当外骨架420处于弯曲状态时,第一侧壁421为大弯侧140,第二侧壁422为小弯侧150,当外骨架420处于自然状态时,第一侧壁421上的最小的网孔的面积S1小于第二侧壁422的最小的网孔的面积S2。The difference between this example and Embodiment 1 is that, as shown in Fig. 6 to Fig. 9, the outer skeleton 420 has a mesh structure, and the outer skeleton 420 includes a first side wall 421 and a second side wall 422, when the outer skeleton 420 is in a bent state , the first side wall 421 is the large curved side 140, and the second side wall 422 is the small curved side 150. When the outer skeleton 420 is in a natural state, the area S1 of the smallest mesh on the first side wall 421 is smaller than the second The area S2 of the smallest mesh of the side wall 422 .

在本实施例中,如图7所示,内骨架410包括第一段411、第二段412和第三段413;其中,第一段411、第三段413和外骨架420由编织丝一体编织形成网状结构,第二段412包括多个沿内骨架410轴向间隔设置的波形环状物4121。In this embodiment, as shown in Figure 7, the inner frame 410 includes a first segment 411, a second segment 412 and a third segment 413; wherein, the first segment 411, the third segment 413 and the outer frame 420 are integrated by braiding wire The weaving forms a network structure, and the second segment 412 includes a plurality of wave-shaped rings 4121 arranged at intervals along the axial direction of the inner skeleton 410 .

在本实施例中,如图7所示,外骨架420由编织丝编织形成网状结构,编织丝可以相互勾挂,也可以仅相交而且相互叠合,外骨架420上的网孔指的是由多根编织丝相交形成的网孔。外骨架420包括弯曲状态和自然状态,在自然状态下,外骨架420呈竖直的管状结构,第一侧壁421和第二侧壁422相对设置,第一侧壁421和第二侧壁422可以沿外骨架420的周向间隔设置或在周向上连续,如图8、图9中外骨架420的展开图所示,第一侧壁421上的最小的网孔的网孔尺寸(即网孔面积S1)小于第二侧壁422上最小网孔的网孔尺寸(即网孔面积S2),具体地,第一侧壁421上的网孔面积S1与第二侧壁422上的网孔面积S2的比例为:1.5~4,具体地,该比例可以为:1.5、2、3或4。如图10所示,在弯曲状态下,外骨架420呈弧形的管状结构,这时,外骨架420包括大弯侧140和小弯侧150,第一侧壁421位于大弯侧140,第二侧壁422位于小弯侧150。In this embodiment, as shown in FIG. 7 , the outer frame 420 is woven with braided wires to form a mesh structure, and the braided wires can be hooked to each other, or can only intersect and overlap each other. The mesh on the outer frame 420 refers to A mesh formed by the intersection of multiple braided filaments. The exoskeleton 420 includes a bent state and a natural state. In the natural state, the exoskeleton 420 is a vertical tubular structure, and the first side wall 421 and the second side wall 422 are arranged oppositely. The first side wall 421 and the second side wall 422 Can be arranged at intervals along the circumferential direction of the outer skeleton 420 or continuously in the circumferential direction, as shown in the expanded view of the outer skeleton 420 in Figure 8 and Figure 9, the mesh size of the smallest mesh on the first side wall 421 (i.e. mesh Area S1) is smaller than the mesh size (i.e. mesh area S2) of the smallest mesh on the second side wall 422, specifically, the mesh area S1 on the first side wall 421 and the mesh area on the second side wall 422 The ratio of S2 is: 1.5-4, specifically, the ratio can be: 1.5, 2, 3 or 4. As shown in Figure 10, in the bent state, the outer frame 420 is an arc-shaped tubular structure. At this time, the outer frame 420 includes a large curved side 140 and a small curved side 150, the first side wall 421 is located on the large curved side 140, the second The two sidewalls 422 are located on the slightly curved side 150 .

值得解释的是,请重新参照图1及图10,分支支架100的一端插入主支架700内,分支支架100的另一端插入分支血管内,分支支架100的中间段呈现较大的弯曲角度。这时,如图11所示(图中实线部分为第二侧壁422在竖直状态下的网孔示意图,虚线部分为第二侧壁422变形后的网孔状态示意图),在管腔支架的小弯侧150,外骨架120上的编织丝相向运动而相互交叠,使网孔面积减小,从而使小弯侧150处的编织丝较为密集;在分支支架100的大弯侧140,如图12所示(图中实线部分为第一侧壁421在竖直状态下的网孔示意图,虚线部分为第一侧壁421变形后的网孔状态示意图),外骨架120上的编织丝相背运动,使大弯侧140处的编织丝较为稀疏,这时,大弯侧140处形成较大面积的网孔,同时在折弯的情况下,覆膜130容易在自身的弹性作用力的情况下贴合于大弯侧140的网孔,导致大弯侧140的覆膜130容易遭到主支架700的摩擦而破损。It is worth explaining that, please refer to FIG. 1 and FIG. 10 again, one end of the branch stent 100 is inserted into the main stent 700, the other end of the branch stent 100 is inserted into the branch vessel, and the middle section of the branch stent 100 presents a relatively large bending angle. At this time, as shown in Figure 11 (the solid line part in the figure is a schematic diagram of the mesh of the second side wall 422 in a vertical state, and the dotted line part is a schematic diagram of the mesh state of the second side wall 422 after deformation), in the lumen On the small curved side 150 of the bracket, the braided wires on the outer frame 120 move toward each other and overlap each other, so that the mesh area is reduced, so that the braided wires at the small curved side 150 are relatively dense; on the large curved side 140 of the branch bracket 100 , as shown in Figure 12 (the solid line part in the figure is a schematic diagram of the mesh of the first side wall 421 in a vertical state, and the dotted line part is a schematic diagram of the mesh state of the first side wall 421 after deformation), the outer skeleton 120 The braiding wires move opposite to each other, so that the braiding wires at the big bend side 140 are relatively sparse. At this time, the big bend side 140 forms a mesh with a larger area. In the case of force, it is attached to the mesh of the large curved side 140 , causing the coating 130 of the large curved side 140 to be easily damaged by the friction of the main bracket 700 .

这样设置的好处在于,在弯曲状态下,第一侧壁421位于大弯侧140,第一侧壁421上的编织丝在内骨架410两端的牵拉下相背运动,使第一侧壁421上的网孔面积变大,通过在自然状态下第一侧壁421上的网孔面积大于第二侧壁422上的网孔面积的设置,使第一侧壁421上的网孔面积变大后仍然具有足够的编织丝密度以在覆膜430的外侧形成阻隔,保障了对大弯侧140处的覆膜430的保护;第二侧壁422位于小弯侧150,第二侧壁422上的编织丝在内骨架410两端的挤压下相向运动,使第二侧壁422上的网孔面积减小,这时,即使在自然状态下第二侧壁422上的网孔面积大于第一侧壁421上的网孔面积,外骨架420仍然可以保持足够编织丝密度以实现对小弯侧150的覆膜430的保护。The advantage of this arrangement is that, in the bent state, the first side wall 421 is located at the big bend side 140, and the braided wires on the first side wall 421 move away from each other under the pull of the two ends of the inner frame 410, so that the first side wall 421 The mesh area on the first side wall 421 becomes larger, and the mesh area on the first side wall 421 becomes larger by setting the mesh area on the first side wall 421 larger than the mesh area on the second side wall 422 in a natural state. Afterwards, there is still enough weaving filament density to form a barrier on the outside of the coating 430, which ensures the protection of the coating 430 at the large curved side 140; the second side wall 422 is located on the small curved side 150, on the second side wall 422 The braided wires move toward each other under the extrusion of the two ends of the inner skeleton 410, so that the mesh area on the second side wall 422 is reduced. At this time, even in the natural state, the mesh area on the second side wall 422 is larger than the first With regard to the mesh area on the side wall 421 , the outer skeleton 420 can still maintain sufficient weaving wire density to protect the coating 430 on the less curved side 150 .

进一步地,在弯曲状态下,为了保证外骨架420的大弯侧140与覆膜430之间具有一定的间隙,如图11至图13所示,第二侧壁422与内骨架410连接,第一侧壁421的至少一处悬浮形成自由端。Further, in the bent state, in order to ensure a certain gap between the large curved side 140 of the outer frame 420 and the coating 430, as shown in Figures 11 to 13, the second side wall 422 is connected to the inner frame 410, the second side wall 422 is connected to the inner frame 410, At least one side wall 421 is suspended to form a free end.

在本实施例中,请继续参照图11以及图13,外骨架420的两端分别与第一段411和第三段413连接,第一侧壁421的两端与覆膜430之间具有间隔距离,外骨架420在内骨架410的外侧悬浮形成自由端,该自由端指的是第一侧壁421的两端未受到内骨架410或覆膜430的约束,例如,在本实施例中,第一侧壁421的两端未与第一段411和第三段413连接,从而,在第一侧壁421的两端,第一侧壁421与内骨架410的力的传递效应被打断或减弱。In this embodiment, please continue to refer to FIG. 11 and FIG. 13 , the two ends of the outer frame 420 are connected to the first segment 411 and the third segment 413 respectively, and there is a gap between the two ends of the first side wall 421 and the covering film 430 distance, the outer frame 420 is suspended outside the inner frame 410 to form a free end, the free end means that the two ends of the first side wall 421 are not constrained by the inner frame 410 or the coating 430, for example, in this embodiment, The two ends of the first side wall 421 are not connected with the first section 411 and the third section 413, thus, at the two ends of the first side wall 421, the force transmission effect between the first side wall 421 and the inner frame 410 is interrupted or weaken.

值得解释的是,在第一侧壁421处,网孔面积较小,编织丝较为密集,从而使第一侧壁421的抗变形性能大于第二侧壁422的抗变形性能,当内骨架410的中间段弯曲时,第一侧壁421会牵拉内骨架410,增加内骨架410的弯曲难度,降低内骨架410的变形性能。其中,该变形性能指的是内骨架410弯曲时的容易程度,变形性能越好,则内骨架410越容易弯曲,变形性能越差,则内骨架410越难弯曲。It is worth explaining that, at the first side wall 421, the mesh area is smaller and the braided filaments are relatively dense, so that the deformation resistance of the first side wall 421 is greater than that of the second side wall 422. When the inner skeleton 410 When the middle section of the inner frame is bent, the first side wall 421 will pull the inner frame 410, which increases the difficulty of bending the inner frame 410 and reduces the deformation performance of the inner frame 410. Wherein, the deformability refers to the ease of bending the inner frame 410 , the better the deformability, the easier the inner frame 410 bends, and the worse the deformability, the harder it is to bend the inner frame 410 .

由此,通过第二侧壁422与内骨架410连接,实现了外骨架420与内骨架410的连接,通过第一侧壁421的至少一端悬浮形成自由端,使第一侧壁421与内骨架410的力的传递在第一侧壁421的两端被打断或减弱,一方面,减弱了第一侧壁421对内骨架410的弯曲变形的干涉,增加了内骨架410的柔顺性;另一方面,在内骨架410弯曲变形时,第一侧壁421受到内骨架410的牵拉作用较弱,使第一侧壁421的弯曲程度小于内骨架410的弯曲程度,从而使第一侧壁421与覆膜430之间具有一定的间隙,让出第一侧壁421受压变形的空间,降低了主支架700与覆膜430接触的概率。Thus, by connecting the second side wall 422 with the inner frame 410, the connection between the outer frame 420 and the inner frame 410 is realized, and at least one end of the first side wall 421 is suspended to form a free end, so that the first side wall 421 and the inner frame The force transmission of 410 is interrupted or weakened at the two ends of the first side wall 421. On the one hand, the interference of the first side wall 421 to the bending deformation of the inner frame 410 is weakened, and the flexibility of the inner frame 410 is increased; On the one hand, when the inner frame 410 is bent and deformed, the first side wall 421 is weakly pulled by the inner frame 410, so that the bending degree of the first side wall 421 is smaller than that of the inner frame 410, so that the first side wall There is a certain gap between the 421 and the covering film 430 , allowing space for the first side wall 421 to be deformed under pressure, and reducing the probability of contact between the main bracket 700 and the covering film 430 .

进一步地,为了避免第一侧壁421受到内骨架410的过度牵拉而造成网孔面积过大,如图9、图14和图15所示,外骨架420由编织丝编织形成,第一侧壁421上的编织丝相互勾挂,第二侧壁422上的编织丝形成的轴向上相邻的波峰与波谷互不干涉。Further, in order to prevent the first side wall 421 from being excessively pulled by the inner skeleton 410 and causing the mesh area to be too large, as shown in Fig. 9, Fig. 14 and Fig. 15, the outer skeleton 420 is formed by weaving braided silk, and the first side The braided wires on the wall 421 are interlocked, and the axially adjacent crests and troughs formed by the braided wires on the second side wall 422 do not interfere with each other.

在本实施例中,外骨架420包括第一编织丝和第二编织丝,第一编织丝编织后经热定型处理形成第一波形结构423,第二编织丝编织后经热定型处理形成第二波形结构424,第一波形结构423包括第一波谷4231,第二波形结构424包括第二波峰4241,如图14所示,在第一侧壁421所在的区域,第二波峰4241处的编织丝从第一波谷4231的内侧穿过然后翻折朝向第二波峰4241的外侧以实现编织丝的相互勾挂;如图15所示,在第二侧壁422所在的区域,第二波峰4241位于第一波谷4231的内侧或外侧,第二波峰4241与第一波谷4231相贴合,第二波峰4241与第一波谷4231不形成干涉。In this embodiment, the outer skeleton 420 includes a first braided wire and a second braided wire, the first braided wire is heat-set to form the first wave structure 423 after weaving, and the second braided wire is heat-set to form the second wave structure 423 after braiding. The wave structure 424, the first wave structure 423 includes a first wave trough 4231, and the second wave structure 424 includes a second wave peak 4241, as shown in FIG. Pass through the inner side of the first wave trough 4231 and then turn over towards the outer side of the second wave peak 4241 to realize mutual hooking of braided filaments; as shown in Figure 15, in the area where the second side wall 422 is located, the second wave peak 4241 is located Inside or outside of a trough 4231 , the second crest 4241 fits the first trough 4231 , and the second crest 4241 does not interfere with the first trough 4231 .

在另一实施例中,在第一侧壁421所在的区域,第二波峰4241越过第一波谷4231时,在第一波谷4231处缠绕多圈,以增加第一波谷4231与第二波峰4241的连接稳定性。在其它的实施例中,在第一侧壁421所在的区域,第二波峰4241的最高点与第一波谷4231的最低点焊接。In another embodiment, in the area where the first side wall 421 is located, when the second crest 4241 crosses the first trough 4231, multiple turns are wound at the first trough 4231 to increase the distance between the first trough 4231 and the second crest 4241. Connection stability. In other embodiments, in the area where the first side wall 421 is located, the highest point of the second crest 4241 is welded to the lowest point of the first trough 4231 .

这样设置的好处在于,当外骨架420跟随内骨架410弯曲变形时,第一侧壁421位于大弯侧140,第一侧壁421上的编织丝在内骨架410两端的牵拉下相背运动,当编织丝相背运动至一定距离时,通过第一侧壁421上的编织丝相互勾挂的设置,使编织丝相互勾挂以限制编织丝相背运动的位移量,从而约束第一侧壁421在弯曲状态下的极限网孔面积,避免第一侧壁421在弯曲状态下的网孔面积过大而导致覆膜430裸露,减弱了外骨架420对覆膜430的保护作用。The advantage of this arrangement is that when the outer skeleton 420 follows the bending deformation of the inner skeleton 410, the first side wall 421 is located on the large curved side 140, and the braided wires on the first side wall 421 move away from each other under the pull of the two ends of the inner skeleton 410 , when the braiding wires move away from each other to a certain distance, the braiding wires on the first side wall 421 are hooked to each other to limit the displacement of the braiding wires moving back to each other, thereby constraining the first side The limit mesh area of the wall 421 in the bent state prevents the covering film 430 from being exposed due to the excessive mesh area of the first side wall 421 in the bending state, and weakens the protective effect of the outer frame 420 on the covering film 430 .

进一步地,如图6、图7所示,内骨架410包括第一段411、第二段412和第三段413,第二段412的柔顺性大于第一段411和第三段413的柔顺性,外骨架420至少位于第二段412的外侧。Further, as shown in FIG. 6 and FIG. 7 , the inner skeleton 410 includes a first segment 411 , a second segment 412 and a third segment 413 , and the compliance of the second segment 412 is greater than that of the first segment 411 and the third segment 413 Specifically, the exoskeleton 420 is located at least on the outside of the second section 412 .

如图7所示,第二段412包括多个波形环状物4121,多个波形环状物4121沿第二段412的轴向间隔设置。在自然状态下,所有波形环状物4121的轴线与第一段411、第三段413的轴线位于同一直线上。相邻的两个波形环状物4121之间具有间隔距离,示例性地,波形环状物4121包括第一波形环状物4121a和第二波形环状物4121b,第一波形环状物4121a包括第一端面,第一端面位于第一波形环状物4121a靠近第二波形环状物4121b的一端,第二波形环状物4121b包括第二端面,第二端面位于第二波形环状4121b物靠近第一波形环状物4121a的一端,第一端面和第二端面之间具有间隔距离d3,间隔距离d3为:-3~5mm;具体地,间隔距离d3可以为-3、-1、0、2或5mm。。As shown in FIG. 7 , the second section 412 includes a plurality of wave-shaped rings 4121 arranged at intervals along the axial direction of the second section 412 . In a natural state, the axes of all the wave-shaped rings 4121 are on the same straight line as the axes of the first section 411 and the third section 413 . There is a distance between two adjacent wave-shaped rings 4121. Exemplarily, the wave-shaped ring 4121 includes a first wave-shaped ring 4121a and a second wave-shaped ring 4121b, and the first wave-shaped ring 4121a includes The first end face, the first end face is located at one end of the first wave-shaped ring 4121a close to the second wave-shaped ring 4121b, the second wave-shaped ring 4121b includes a second end face, and the second end face is located near the second wave-shaped ring 4121b At one end of the first wave-shaped ring 4121a, there is a distance d3 between the first end surface and the second end surface, and the distance d3 is -3 to 5 mm; specifically, the distance d3 can be -3, -1, 0, 2 or 5mm. .

在本实施例中,如图11所示,第一段411、第三段413和外骨架420由编织丝一体编织形成,第一段411、第三段413和外骨架420整体呈网状结构,第一段411、第三段413分别位于外骨架420的轴向两端,第一段411和第三段413的内径小于外骨架420的内径,第一段411和第三段413上的网孔面积可以相同或不同,在自然状态下,第一段411、第三段413和外骨架420的轴线位于同一直线上。In this embodiment, as shown in FIG. 11 , the first segment 411, the third segment 413 and the outer frame 420 are integrally braided and formed by braiding wires, and the first segment 411, the third segment 413 and the outer frame 420 form a network structure as a whole , the first section 411 and the third section 413 are respectively located at the two axial ends of the outer skeleton 420, the inner diameters of the first section 411 and the third section 413 are smaller than the inner diameter of the outer skeleton 420, the first section 411 and the third section 413 are The mesh areas can be the same or different. In a natural state, the axes of the first section 411, the third section 413 and the outer frame 420 are located on the same straight line.

如图16所示,覆膜430包括内覆膜431和外覆膜432,内覆膜430位于第一段411、第二段412和第三段413的内侧,且覆盖于第一段411、第二段412和第三段413的内侧壁,使内骨架410形成密封通道。外覆膜432包括第一外覆膜4321、第二外覆膜4322和第三外覆膜4323,第一外覆膜4321包覆于第一段411的外侧壁,第二外覆膜4322覆盖于第二段412的外侧壁,第三外覆膜4323覆盖第三段413的外侧壁,当外覆膜430包覆完第一段411、第二段412和第三段413后,外骨架420位于第二外覆膜4322的外侧壁,从而实现对第二外覆膜4322的保护。As shown in Figure 16, the covering film 430 includes an inner covering film 431 and an outer covering film 432, the inner covering film 430 is located inside the first section 411, the second section 412 and the third section 413, and covers the first section 411, The inner side walls of the second section 412 and the third section 413 make the inner frame 410 form a sealed channel. The outer covering film 432 includes a first outer covering film 4321, a second outer covering film 4322 and a third outer covering film 4323. The first outer covering film 4321 covers the outer side wall of the first section 411, and the second outer covering film 4322 covers On the outer wall of the second section 412, the third outer covering film 4323 covers the outer wall of the third section 413. After the outer covering film 430 covers the first section 411, the second section 412 and the third section 413, the outer skeleton 420 is located on the outer wall of the second outer covering film 4322 , so as to realize the protection of the second outer covering film 4322 .

由此,当内骨架410折弯时,通过第二段412包括多个波形环状物4121,多个波形环状物4121间隔设置,使多个波形环状物4121之间并不会相互干涉,从而使第二段412更容易被弯曲,因此柔顺性更好,在弯曲状态下仍然能保持较好的圆形管腔,保证的血液的流畅性。Therefore, when the inner skeleton 410 is bent, the second section 412 includes a plurality of wave-shaped rings 4121, and the plurality of wave-shaped rings 4121 are arranged at intervals, so that the plurality of wave-shaped rings 4121 will not interfere with each other , so that the second section 412 is easier to be bent, so the flexibility is better, and a good circular lumen can still be maintained in the bent state, ensuring smoothness of blood.

值得解释的是,对内骨架410的柔顺性的测试方法可依照YY/T0663.2-2016《心血管植入物血管内器械第二部分:血管支架》中的附录D中的D.5.3.6弯曲/打折的部分来进行。例如,在一种实施方式中,将管腔支架放到直管内,将装载支架的直管放到圆柱测径规上,测试最恶劣情况下支架的方向;将装载支架的导管绕在量规上,使支架的整个长度可以和量规解除,或最大弯曲180°;记录半径,以及是否观察到严重狭窄发生;撤掉施加在支架上的力,记录支架是否能恢复到初始几何行政;逐渐减小量规半径,并重复记录半径及严重下载的发生情况,直到有打折或支架直径减小了50%为止。It is worth explaining that the test method for the flexibility of the endoskeleton 410 can be in accordance with D.5.3 in Appendix D of YY/T0663.2-2016 "Cardiovascular Implants and Intravascular Devices Part II: Vascular Stents". 6 bent/folded sections to make. For example, in one embodiment, the luminal stent is placed in a straight tube, the stent-loaded straight tube is placed on a cylindrical caliper gauge, and the worst case orientation of the stent is tested; the stent-loaded catheter is wound around the gauge , so that the entire length of the stent can be released from the gauge, or a maximum bend of 180°; record the radius, and whether severe stenosis is observed; remove the force applied to the stent, and record whether the stent can return to the original geometric administration; gradually reduce Gauge the radii and record the radii and occurrences of severe downloading repeatedly until there is a discount or the stent diameter is reduced by 50%.

进一步地,请再参照图16,第一外覆膜4321、第二外覆膜4322和第三外覆膜4323间隔设置。Further, please refer to FIG. 16 again, the first outer covering film 4321 , the second outer covering film 4322 and the third outer covering film 4323 are arranged at intervals.

需要说明的是,第一外覆膜4321包覆于第一段411的外侧壁,第一外覆膜4321和第二外覆膜4322之间具有间隔距离,使第一段411与第二段412相连处的外覆膜432隔断,第二外覆膜4322和第三外覆膜4323之间具有间隔距离,使第三段413与第二段412相连处的外覆膜隔断。由此,通过第一外覆膜4321和第二外覆膜4322间隔设置,使第一外覆膜4321和第二外覆膜4322之间具有间隙,通过第二外覆膜4322和第三外覆膜4323间隔设置,使第二外覆膜4322和第三外覆膜4323之间具有间隙,可以避免外覆膜432覆盖于外骨架420处,从而增加了外骨架420的柔顺形。It should be noted that the first outer covering film 4321 is wrapped on the outer wall of the first section 411, and there is a distance between the first outer covering film 4321 and the second outer covering film 4322, so that the first section 411 and the second section The outer covering film 432 at the junction of 412 is cut off, and there is a distance between the second outer covering film 4322 and the third outer covering film 4323 , so that the outer covering film at the junction of the third section 413 and the second section 412 is cut off. Thus, the first outer covering film 4321 and the second outer covering film 4322 are arranged at intervals, so that there is a gap between the first outer covering film 4321 and the second outer covering film 4322, and the second outer covering film 4322 and the third outer covering film 4322 The coatings 4323 are arranged at intervals, so that there is a gap between the second outer coating 4322 and the third outer coating 4323 , which can prevent the outer coating 432 from covering the outer frame 420 , thereby increasing the compliance of the outer frame 420 .

进一步地,为了便于该管腔支架压缩进输送装置内,如图16所示,外骨架420上的编织丝的交点p位于相邻的两个波形环状物4121之间。例如,在一种实施方式中,多个波形环状物4121间隔设置,相邻的两个波形环状物4121之间形成编织丝的交点p的容置空间。Further, in order to facilitate the compression of the endoluminal stent into the delivery device, as shown in FIG. 16 , the intersection point p of the braided wires on the outer skeleton 420 is located between two adjacent wave-shaped rings 4121 . For example, in one embodiment, a plurality of wave-shaped rings 4121 are arranged at intervals, and an accommodating space for the intersection point p of the braided yarn is formed between two adjacent wave-shaped rings 4121 .

由此,当该管腔支架需要被压缩进输送装置内以经血管递送至目标位置时,通过外骨架420上的编织丝的交点p位于相邻的两个波形环状物4121之间,使相邻的两个波形环状物4121之间可以形成编织丝交点p的容置空间,从而可以最大程度地利用第二段4121上的空间,降低该管腔支架被压缩进输送装置的难度。Therefore, when the endoluminal stent needs to be compressed into the delivery device for transvascular delivery to the target position, the intersection point p of the braided wire passing through the outer skeleton 420 is located between two adjacent wave-shaped rings 4121, so that An accommodating space for the intersecting point p of the braided wire can be formed between two adjacent wave-shaped rings 4121, so that the space on the second section 4121 can be utilized to the greatest extent, and the difficulty of compressing the endoluminal stent into the delivery device can be reduced.

进一步地,为了便于工作人员识别弯曲段的位置,请再参照图6、图7,管腔支架还包括多个显影结构440,多个显影结构440分别设置于第二段412的轴向两端。需要说明的是,显影结构440由显影材料制成,显影材料可以为钽、铂、金等显影效果良好材料,显影结构440包括显影丝,显影丝缠绕于第二段412轴向两端的波形环状物4121上。在其它的实施例中,第二段412两端的波形环状物4121上焊接有显影材料。由此,通过在第二段412的轴向两端设置显影结构440,在支架的释放过程中,可以标识出外骨架420的位置,便于工作人员识别此处该位置更适合与其它支架配合。Further, in order to facilitate the staff to identify the position of the curved section, please refer to Fig. 6 and Fig. 7 again, the lumen support further includes a plurality of developing structures 440, and the multiple developing structures 440 are respectively arranged at the two axial ends of the second segment 412 . It should be noted that the developing structure 440 is made of a developing material, which can be a material with good developing effect such as tantalum, platinum, gold, etc. The developing structure 440 includes a developing wire, and the developing wire is wound around the corrugated rings at both ends of the second segment 412 in the axial direction. On the object 4121. In other embodiments, the developer material is welded on the corrugated rings 4121 at both ends of the second segment 412 . Therefore, by arranging the developing structures 440 at both ends of the second section 412 in the axial direction, the position of the outer frame 420 can be marked during the release process of the stent, which is convenient for the staff to identify that this position is more suitable for matching with other stents.

这样,当管腔支架与主支架700配合使用时,折弯通常发生于第二段412处,通常与主支架700摩擦的区域也发生于第二段412,通过第二段412的柔顺性较大的设置,使第二段412在弯曲状态下仍然能保持较好的圆形管腔,保证的血液的流畅性,通过外骨架420仅覆盖于中间段412的设置,使外骨架420不需要整体覆盖内骨架410,从而减小了外骨架420的覆盖面积,降低了该管腔支架被压缩装载进输送装置的难度。In this way, when the endoluminal stent is used in conjunction with the main stent 700, the bending usually occurs at the second section 412, and the area of friction with the main stent 700 usually also occurs at the second section 412, and the flexibility through the second section 412 is relatively high. The large setting enables the second section 412 to still maintain a better circular lumen in a curved state, ensuring the smoothness of blood, and the outer framework 420 only covers the middle section 412 so that the outer framework 420 does not need The inner framework 410 is entirely covered, thereby reducing the coverage area of the outer framework 420 and reducing the difficulty of compressing and loading the endoluminal stent into the delivery device.

在其它的实施例中,如图17所示,第一段511、第二段512和第三段513均包括多个间隔设置的波形环状物,其中,第一段511、第三段513上的相邻的两个波形环状物的波形相位相反,第二段512上的相邻的两个波形环状物的波形相位相同。例如,在一种实施方式中,第二段512包括第一波形环状物和第二波形环状物,第一波形环状物包括第一波峰5121和第一波谷5122,第二波形环状物包括第二波峰5123和第二波谷5124,第一波峰5121和第二波峰5123位于同一竖直线上,第一波谷5122和第二波谷5124位于同一竖直线上,从而使第二段512上相邻的两个波形环状物的波形相位相同。第一段511包括第三波形环状物和第四波形环状物,第三波形环状物包括第三波峰5111和第三波谷5112,第四波形环状物包括第四波峰5113和第四波谷5114,第三波峰5111和第四波谷5114相对设置,第三波5112谷和第四波峰5113相对设置,从而使第一段511上的相邻的两个波形环状物的波形相位相反。第三段513包括第五波形环状物和第六波形环状物,第五波形环状物包括第五波峰5131和第五波谷5132,第六波形环状物包括第六波峰5133和第六波谷5134,第五波峰5131和第六波谷5134相对设置,第五波谷5132和第六波峰5133相对设置,从而使第三段513上的相邻的两个波形环状物的波形相位相反。由此,通过第二段512上的波形环状物的波形相位相同,使相邻的两个波形环状物之间具有较大的间隙,为相邻的两个波形环状物提供一定的位移空间,从而使第二段512具有较好的柔顺性,通过第一段511和第三段513上的相邻的两个波形环状物的波形相位相反的设置,当内骨架510弯曲时,相邻的两个波形环状物相互干涉,从而使第一段511和第三段513具有较好的抗弯曲性能。In other embodiments, as shown in FIG. 17 , the first section 511, the second section 512 and the third section 513 each include a plurality of wave rings arranged at intervals, wherein the first section 511, the third section 513 The phases of the waveforms of the two adjacent waveform rings on the second section 512 are opposite, and the phases of the waveforms of the two adjacent waveform rings on the second section 512 are the same. For example, in one embodiment, the second segment 512 includes a first waveform ring and a second waveform ring, the first waveform ring includes a first peak 5121 and a first valley 5122, the second waveform ring The object includes a second peak 5123 and a second valley 5124, the first peak 5121 and the second peak 5123 are located on the same vertical line, the first valley 5122 and the second valley 5124 are located on the same vertical line, so that the second section 512 The phases of the waveforms of two adjacent waveform rings are the same. The first segment 511 includes a third wave ring and a fourth wave ring, the third wave ring includes a third peak 5111 and a third valley 5112, and the fourth wave ring includes a fourth peak 5113 and a fourth wave ring. The trough 5114, the third peak 5111 and the fourth trough 5114 are set opposite to each other, and the trough of the third wave 5112 is set opposite to the fourth peak 5113, so that the phases of the two adjacent waveform rings on the first section 511 are reversed. The third section 513 includes a fifth waveform ring and a sixth waveform ring, the fifth waveform ring includes a fifth peak 5131 and a fifth valley 5132, and the sixth waveform ring includes a sixth peak 5133 and a sixth The wave trough 5134, the fifth wave peak 5131 and the sixth wave trough 5134 are set opposite to each other, and the fifth wave trough 5132 and the sixth wave peak 5133 are set opposite to each other, so that the phases of the waveforms of the two adjacent wave rings on the third section 513 are reversed. Thus, the waveform phases of the wave-shaped rings on the second section 512 are the same, so that there is a larger gap between two adjacent wave-shaped rings, and a certain degree of space is provided for the two adjacent wave-shaped rings. Displacing space, so that the second section 512 has better flexibility, through the configuration of the wave phases of the adjacent two wave-shaped rings on the first section 511 and the third section 513, when the inner skeleton 510 bends , two adjacent wave-shaped rings interfere with each other, so that the first segment 511 and the third segment 513 have better bending resistance.

实施例四Embodiment Four

本实施例提供一种支架系统,如图18所示,该支架系统包括如上所述的管腔支架600和主支架800,主支架600与管腔支架800并列设置,管腔支架600的一端弯曲朝向分支血管,外骨架至少部分与主支架的外侧壁贴合,从而,外骨架可以降低或消除主支架与覆膜的摩擦力,从而实现了对覆膜的保护,防止覆膜在主支架的摩擦下破裂,引起内漏This embodiment provides a stent system. As shown in FIG. 18 , the stent system includes the luminal stent 600 and the main stent 800 as described above, the main stent 600 and the luminal stent 800 are arranged side by side, and one end of the luminal stent 600 is bent Facing the branch vessels, the outer frame is at least partially attached to the outer wall of the main stent, so that the outer frame can reduce or eliminate the friction between the main stent and the membrane, thereby realizing the protection of the membrane and preventing the membrane from being damaged by the main bracket. Crack under friction, causing internal leakage

在另一实施例中,主支架800上开设有通孔,管腔支架600插设于通孔内且至少部分位于主支架800的外侧。管腔支架600的外骨架与通孔的侧壁相贴合。通过该管腔支架包括内骨架和外骨架,使外骨架位于位于覆膜的外侧,从而使外骨架可以保护覆膜,防止覆膜在主支架的摩擦下破裂,引起内漏。In another embodiment, the main stent 800 is provided with a through hole, and the endoluminal stent 600 is inserted into the through hole and at least partly located outside the main stent 800 . The outer frame of the lumen support 600 fits the side wall of the through hole. The lumen stent includes an inner skeleton and an outer skeleton, so that the outer skeleton is located outside the membrane, so that the outer framework can protect the membrane and prevent the membrane from breaking under the friction of the main bracket and causing endoleak.

以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。The technical features of the above-mentioned embodiments can be combined arbitrarily. To make the description concise, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, should be considered as within the scope of this specification.

以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。The above-mentioned embodiments only express several implementation modes of the present invention, and the descriptions thereof are relatively specific and detailed, but should not be construed as limiting the patent scope of the invention. It should be noted that, for those skilled in the art, several modifications and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent for the present invention should be based on the appended claims.

Claims (10)

1. The utility model provides a lumen support, its characterized in that includes tubular main part and tectorial membrane, tubular main part includes inner skeleton and exoskeleton, the tectorial membrane set up in on the inner skeleton, the exoskeleton cover is located on the inner skeleton, the exoskeleton is used for the outside of tectorial membrane forms the inoxidizing coating.
2. The luminal stent of claim 1, wherein the exoskeleton is a mesh structure, the exoskeleton comprises a first side wall and a second side wall, the area of the smallest mesh on the first side wall is smaller than the area of the smallest mesh on the second side wall when the exoskeleton is in a natural state, the first side wall is a large curved side and the second side wall is a small curved side when the exoskeleton is in a curved state.
3. The luminal stent of claim 2, wherein the second side wall is connected to the inner frame and at least one of the first side wall is suspended to form a free end.
4. The luminal stent of claim 2 wherein the exoskeleton is formed by braiding of braided filaments, wherein the braided filaments on the first side wall are hooked to each other, and wherein two adjacent peaks and valleys in the axial direction formed by the braided filaments on the second side wall do not interfere with each other.
5. The luminal stent of claim 1, wherein the inner scaffold comprises a first section, a second section, and a third section, the second section is positioned between the first section and the third section, and the second section has a compliance that is superior to a compliance of the first section and the third section, and the outer scaffold covers the second section.
6. The luminal stent of claim 5, wherein the second section comprises a plurality of undulating rings, the plurality of undulating rings being disposed at intervals along an axial direction of the second section.
7. The luminal stent of claim 6, wherein the wavy rings comprise peaks and valleys, the peaks on axially adjacent two of the wavy rings being in the same line and the valleys on axially adjacent two of the wavy rings being in the same line.
8. The luminal stent of claim 6, wherein the intersection of braided wires on the exoskeleton is located between two axially adjacent wavy rings of the second section.
9. The luminal stent of claim 5, wherein the first section, the exoskeleton and the third section are integrally woven, the first section and the third section having an outer diameter that is less than an outer diameter of the exoskeleton.
10. The luminal stent of claim 5, further comprising two visualization structures disposed at each end of the second section.
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Citations (10)

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CN111920558A (en) * 2020-07-08 2020-11-13 复旦大学 Intracranial aneurysm blood flow guiding bracket
CN113017753A (en) * 2021-02-26 2021-06-25 珠海通桥医疗科技有限公司 Blood vessel support

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005110779A (en) * 2003-10-03 2005-04-28 Piolax Medical Device:Kk Stent
CN105662666A (en) * 2015-12-30 2016-06-15 先健科技(深圳)有限公司 Lumen stent
US20200179144A1 (en) * 2016-03-31 2020-06-11 CARDINAL HEALTH SWITZERLAND 515 GmbH Helical ultra low foreshortening stent
CN108013955A (en) * 2016-11-04 2018-05-11 先健科技(深圳)有限公司 Intravascular stent
CN208319371U (en) * 2017-07-05 2019-01-04 上海长海医院 A kind of stent graft
WO2019042202A1 (en) * 2017-08-28 2019-03-07 先健科技(深圳)有限公司 Covered stent
CN107550601A (en) * 2017-10-11 2018-01-09 李鑫 A kind of pre- windowing aorta tectorial membrane stent and its induction system and application method
CN108158701A (en) * 2018-02-09 2018-06-15 天津市胸科医院 For treating the biological absorbable membrane part overlay film frame of bifurcated lesions coronary artery perforation
CN111920558A (en) * 2020-07-08 2020-11-13 复旦大学 Intracranial aneurysm blood flow guiding bracket
CN113017753A (en) * 2021-02-26 2021-06-25 珠海通桥医疗科技有限公司 Blood vessel support

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