WO2013097759A1 - 编织支架 - Google Patents

编织支架 Download PDF

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Publication number
WO2013097759A1
WO2013097759A1 PCT/CN2012/087799 CN2012087799W WO2013097759A1 WO 2013097759 A1 WO2013097759 A1 WO 2013097759A1 CN 2012087799 W CN2012087799 W CN 2012087799W WO 2013097759 A1 WO2013097759 A1 WO 2013097759A1
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WO
WIPO (PCT)
Prior art keywords
wires
stent
woven
wire
woven support
Prior art date
Application number
PCT/CN2012/087799
Other languages
English (en)
French (fr)
Inventor
谢志永
吕健
王森
徐晓红
张晓明
倪尊张
宋林飞
金巧蓉
罗七一
Original Assignee
上海微创医疗器械（集团）有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海微创医疗器械（集团）有限公司 filed Critical 上海微创医疗器械（集团）有限公司
Publication of WO2013097759A1 publication Critical patent/WO2013097759A1/zh

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Classifications

    • 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

Definitions

  • the present invention relates to the field of vascular interventional medicine, and in particular, the present invention relates to a woven mesh tubular stent. Background technique
  • the common diseases of cardiovascular and cerebrovascular diseases are arterial stenosis, aneurysm, etc. If these diseases are not treated in time, they may cause clogging of blood vessels and rupture of tumors, which will seriously endanger human life.
  • surgical procedures such as surgical resection or clipping are used in the early stage.
  • microtrauma interventions such as stent closure or coils and liquid embolization are currently used. Such methods have made great progress in terms of technically small trauma, high safety, and good therapeutic effect.
  • the methods used in microtrauma intervention have their own advantages and disadvantages.
  • the dense mesh woven stent has received extensive attention due to its good flexibility, strong supporting force, good adherence and its small influence on branch vessels.
  • the end wire is generally not subjected to a special fixation or a special structural design, thereby exhibiting a uniform diverging original weaving state.
  • US Patent Publication No. 2007/01 12415 A1 discloses a radially self-expanding stent for implantation in a body passage, comprising first and second sets of metal filaments, the first and the The two sets of metal filaments are woven together and define a tubular stent body having two ends, wherein some or all of the filament ends are fixed together in pairs at the ends of the stent body.
  • the Chinese patent document CN2817765Y discloses an intraluminal stent woven with a medical NiTi alloy wire with a point , which comprises a bracket, which is woven into a stent mesh by a NiTi alloy wire to form a cylindrical shape, and the end of the alloy wire is folded at the end. Connected to the mesh in the bracket net. The end of the NiTi alloy wire is folded to the inside of the support net and connected to the wire point, and the pitch is 1.5mm-2mm.
  • Chinese Patent Publication No. CN1201381A discloses a self-expanding braided dilatation tube for human body lumen replacement grafting, which has a radially expanded configuration in which the angle ⁇ between the filaments is an acute angle.
  • Cicranial temporary stent which is a tubular network structure woven from a memory alloy wire, the middle portion of the stent is a cylindrical straight section, and both ends of the stent It is a conical cone section, the cone section is smoothly transitioned at the junction with the straight section, and the ends of the memory alloy wire at one end of the bracket are fixed together to form the tip end of the conical cone section.
  • the end of the bracket is that two adjacent braided wires are twisted together in pairs, or all the braided wires are tied together to form a taper, or the end of the alloy wire is folded toward the inside of the stent net and the mesh. Click to connect. After the stent is placed in the human body, the end wire can be prevented from being damaged to human tissues. However, when the end is paired or the single wire is folded, the number of defects is increased, which increases the size of the stent during the compression of the stent and affects the conveying performance of the stent. And the above various design and production are relatively complicated. Moreover, none of the ends of the brackets have a development design. Summary of the invention
  • the object of the present invention is to develop a woven stent which can effectively prevent the wire at the end of the stent from being scattered, and improve the adherence and conveying performance of the stent.
  • a woven support which is woven from a plurality of wires, characterized in that: according to the number of wires of the woven support, the wire of the end of the woven support is divided into several Strands, in which each wire in each wire is fixed together.
  • the number of wires in each wire is the same or different.
  • the entire bracket end of the braided bracket is flat or has a bell mouth shape.
  • each of the wires in each of the wires are woven together or directly affixed together without weaving.
  • each of the wires in each of the wires is fixed together by direct weaving and heat treatment.
  • each of the wires in each of the wires is fixed together by a developing ring.
  • each of the wires in each of the wires is bundled and fastened by winding the ends of the wires at the ends of the wires.
  • each of the wires in each of the wires is fixed together using end closure of the bioglue.
  • each wire in each wire is spliced
  • the method is fixed together.
  • the end wire of the woven support can be processed by means of strand weaving or splitting directly with the developing material, so that different designs can be flexibly selected according to needs, and the wire at the end of the bracket can be effectively prevented from being scattered.
  • each braided wire can be selected according to the needs of different numbers of wire; end of the braided wire can be selected with a developable material, so that the distal and proximal ends of the stent under X-ray Good visibility, convenient for doctors to operate and locate.
  • Fig. 1A is a side view of a woven stent of a first embodiment of the present invention.
  • Fig. 1B is an end view of the end portion of the woven stent of the first embodiment of the invention shown in Fig. 1A.
  • Figure 2 is a side elevational view of a woven stent in accordance with a second embodiment of the present invention.
  • Figure 3 is a side view of a woven bracket of a third embodiment of the present invention. detailed description
  • the object of study of the present invention is a woven mesh tubular stent, i.e., a woven stent.
  • the present invention generally relates to an end special structure and development design for use in a woven stent.
  • the present invention specifically designs the wire of the end portion of the braided stent so that the end wire is fixed by stranding to prevent the wire at the end of the stent from being scattered and to improve the adherence of the stent.
  • the present invention can also mount a developing device at the end of the braided stent to improve the visibility of the distal end and the proximal end of the stent under X-rays. Preferred embodiments of the present invention are described in detail below with reference to the accompanying drawings.
  • Fig. 1A is a side view of a woven bracket of a first embodiment of the present invention.
  • Fig. 1B is an end view of the end of the woven stent of the first embodiment of the invention shown in Fig.
  • the woven support consists of 24 braided wires. 24 braided wires were divided into 4 strands at the end of the stent. Alternatively, 24 braided wires can be divided into 6 or 8 strands at the end of the stent. Each of the wires in each of the wires is woven together and fixed by heat treatment to be fixed together. The entire stent end of the braided stent is straight.
  • Figure 2 is a side elevational view of a woven stent in accordance with a second embodiment of the present invention. As shown, the woven support consists of 32 braided wires.
  • FIG. 3 is a side view of a woven stent of a third embodiment of the present invention, in which a state in which one of the woven wires is bundled together by the developing wire is shown in an enlarged view.
  • the woven support consists of 48 braided wires.
  • the 48 braided wires were evenly divided into 4 strands at the end of the stent, wherein there were 12 braided wires per strand, and the 12 braided wires were bundled and fixed together by the developing wires.
  • the end of the entire braided stent is shaped into a flared shape to improve the adherence of the ends.
  • the braided stent is made of the end of the stent wire according to the number of its specific wire (such as 24, 32, 48, 64, 72, 96, etc.). It is divided into several shares (such as 3 shares, 4 shares, 6 shares, 8 shares, etc.), in which each wire in each wire is fixed together.
  • the number of wires in each wire can be the same (ie, evenly distributed, such as three strands, four strands, etc.), or different; the entire braided stent end can be straight, It can also be flared; the ends of each braided wire can be woven together or directly woven together without weaving.
  • the ends of each wire can be fixed by: directly tying and heat-treating and fixing together; fixing the ends of the wires together by a developing ring; winding the wires at the ends of the wires by the developing wires Bundles are tied together; fixed together with bio-glue for end plugging; or fixed using a splicing method.
  • the developing ring and the developing wire are made of a material having good X-ray opaque performance, high corrosion resistance and good biocompatibility, and the material may be gold, platinum, rhodium, ruthenium, iridium, tungsten, ruthenium, iridium or the like or Alloys of these materials.
  • the fixing of the developing ring or the developing wire at the end of the stent and its development under the medical imaging device enable the doctor to more intuitively recognize the position and shape of the stent, thereby facilitating the operation of the doctor.
  • the end wire of the woven support can be processed by means of strand weaving or splitting directly with the developing material, so that different designs can be flexibly selected according to needs, and the wire at the end of the bracket can be effectively prevented from being scattered. , improve the adherence of the stent.
  • Each strand of braided wire can be selected to have a different number of wires as needed.
  • the binding of the end braided wire can be selected from a developable material so that the distal end and the proximal end of the stent are well visible under X-ray, facilitating the operation and positioning of the doctor.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (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)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

一种编织支架，其由多根丝材编织而成。根据编织支架丝材的根数，把支架端部丝材分成若干股。每股中的各根丝材被固定在一起。该编织支架可以防止支架端部散乱，提高了支架贴壁性和输送性能。

Description

编织支架 技术领域
本发明涉及血管介入医疗领域， 具体地， 本发明涉及编织的网管 状支架。 背景技术
目前， 心脑血管常见的疾病主要有动脉狭窄、 动脉瘤等， 这些疾 病若不及时治疗可能会导致血管堵塞、 瘤体破裂， 将严重危害人类的 生命安全。 对于动脉瘤的治疗， 早期主要采用手术切除或夹闭等外科手术。 随着时代的进步， 目前主要采用微创伤介入术， 如支架封堵或弹簧圈、 液体栓塞等治疗方法。 此类方法对病人的创伤小， 安全性高， 且治疗 效果良好， 因而在技术上取得了长足的进步。 目前， 微创伤介入术所 用的方法各有利弊， 大都是将动脉瘤壁与正常血液隔离， 改变血流状 态， 从而使血栓形成， 期望动脉瘤口产生内皮化。 其中， 密网孔的编 织支架由于其良好的柔顺性、 较强的支撑力、 良好的贴壁性以及其对 分支血管较小的影响而受到广泛的关注。 目前， 对于由多根丝材编织而成的血管支架， 其端部丝材一般未 经过特殊的固定或特殊的结构设计， 因而呈现均匀的发散的原始编织 状态。 该种支架在使用过程中可能会产生散乱， 也可能会有部分丝材 的端部从编织结构里脱离出来而悬浮到血管中， 影响了支架端部的贴 壁性， 严重时会提高引发血栓的可能性。 美国专利文献 US2007/01 12415A1公开了一种用于植入在人体通 道内的径向自膨胀支架， 其包括第一和第二组金属细丝， 该第一和第 二组金属细丝被编织在一起且限定了具有两个端部的管状支架本体， 其中在支架本体的端部处细丝端部中的一些或全部被成对固定在一 起。 中国专利文献 CN2817765Y公开了一种收口采用点悍的医用 NiTi 合金丝编织的管腔内支架， 其包括有支架， 支架由 NiTi合金丝编织成支 架网以形成筒状， 合金丝的收尾末端头折向支架网内与网丝悍接成一 体。 NiTi合金丝的收尾末端头折向支架网内部与网丝点悍连接， 其点悍 间距为 1.5mm-2mm。 中国专利文献 CN1201381A公开了一种用于人体腔管置换移植的 自膨胀型编织扩张管， 其有一径向膨胀形态， 在该形态下细丝间的夹 角 α是锐角。 在扩张管的两端， 某些或全部细丝成对地悍接在一起， 以 形成一些小球， 从而提高扩张管的强度， 有助于其从一输送装置上安 装。 中国专利文献 CN201930101U公开了一种颅内临时支架，所述支架 是由记忆合金丝编织而成的管网状结构， 所述支架的中间部分是圆柱 形的平直段， 所述支架的两端是圆锥形的锥段， 所述锥段与所述平直 段的相接处平滑过渡， 在所述支架一端的记忆合金丝的末端被固定在 一起， 以形成圆锥形的锥段的顶端。 在上述专利文献中的支架的端部为相邻两根编织丝成对悍接在一 起， 或者所有编织丝束缚在一起成为锥形， 或者合金丝的收尾末端头 折向支架网内部与网丝点悍连接。 上述支架置入人体后可避免端部丝 材对人体组织产生损伤。 但是， 端部成对悍接或单根丝折叠悍接时悍 点较多， 会增大支架压缩时在输送器中的尺寸， 影响支架的输送性能。 并且上述各种设计制作相对比较复杂。 并且， 上述支架的端部都无显 影设计。 发明内容
鉴于现有技术的上述编织支架的不足， 本发明的目的在于开发一 种编织支架， 其能有效防止支架端部丝材散乱， 提高支架贴壁性和输 送性能。 根据本发明， 提供了一种编织支架， 该编织支架由多根丝材编织 而成， 其特征在于： 根据该编织支架的丝材根数， 该编织支架的端部 的丝材被分为若干股， 其中每股丝材中的各根丝材被固定在一起。 优选地， 每股丝材中的丝材根数是相同的， 或者是不同的。 优选地， 所述编织支架的整个支架端部为平直状， 或者为喇叭口 状。 优选地， 在该编织支架的端部， 每股丝材中的各根丝材被编织在 一起， 或者未经编织而直接被固定在一起。 优选地， 在该编织支架的端部， 每股丝材中的各根丝材通过直接 编织并热处理而被固定在一起。 优选地， 在该编织支架的端部， 每股丝材中的各根丝材通过显影 环而被固定在一起。 优选地， 在该编织支架的端部， 每股丝材中的各根丝材通过显影 丝在丝材端部进行缠绕而被捆扎固定在一起。 优选地， 在该编织支架的端部， 每股丝材中的各根丝材使用生物 胶水进行端部封堵而被固定在一起。 优选地， 在该编织支架的端部， 每股丝材中的各根丝材使用悍接 方法而被固定在一起。 根据本发明， 编织支架的端部丝材可采用分股编织的方式或者分 股直接用显影材料束缚的方式进行处理， 因而可依据需要来灵活选择 不同的设计， 有效防止支架端部丝材散乱， 提高支架贴壁性； 每股编 织丝材可根据需要选择不同数目的丝材组成； 端部编织丝材的束缚可 以选用可显影的材料， 以使支架的远端与近端在 X光下可视性良好， 方 便医生的操作与定位。 附图说明
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 述中所需要使用的附图作简单地介绍。 显而易见的是， 下面描述中的 附图仅仅是本申请中记载的一些特定实施例， 其不是对本发明的保护 范围的限制。 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， 当然还可以根据本发明的这些实施例及其附图获得一些其它 的实施例和附图。
图 1A是本发明第一实施例的编织支架的侧视图。
图 1B是图 1A中所示的本发明第一实施例的编织支架的端部的端 视图。
图 2是本发明第二实施例的编织支架的侧视图。
图 3是本发明第三实施例的编织支架的侧视图。 具体实施方式
为了使本技术领域的人员更好地理解本申请中的技术方案， 下面 将结合本发明实施例中的附图， 对本发明实施例中的技术方案进行清 楚、 完整地描述。 显然， 所描述的实施例仅仅是本申请一部分实施例， 而不是全部的实施例。 基于本申请所述的具体实施例， 本领域普通技 术人员在没有做出创造性劳动的前提下所获得的所有其它实施例， 都 应当落在本发明构思范围之内。 本发明的研究对象是编织的网管状支架、 即编织支架。 本发明总 体涉及一种应用于编织支架的端部特殊结构及显影设计。 具体而言， 本发明对于编织支架的端部的丝材进行了特殊设计， 使其端部丝材被 分股固定， 以防止支架端部丝材散乱， 提高支架贴壁性。 此外， 本发 明还可在编织支架端部安装显影装置， 以提高支架远端与近端在 X光下 的可视性。 以下具体参考附图来详细描述本发明的优选实施例。 图 1A是本发明第一实施例的编织支架的侧视图。图 1B是图 1A中所 示的本发明第一实施例的编织支架的端部的端视图。 如图所示， 编织 支架由 24根编织丝材构成。 24根编织丝材在支架端部被分为 4股。 可选 的是， 24根编织丝材在支架端部也可被分为 6股或 8股。 每股丝材中的 各根丝材分别编织在一起并经热处理后定型而被固定在一起。 所述编 织支架的整个支架端部为平直状。 图 2是本发明第二实施例的编织支架的侧视图。 如图所示， 编织支 架由 32根编织丝材构成。 32根编织丝材在支架端部被均匀地分为 4股， 每股丝材分别编织在一起。 可选的是， 32根编织丝材在支架端部也可 被均匀地分为 8股。 每股丝材端部添加一个扁管状的显影环， 该显影环 将丝材固定在一起， 同时还能起到显影作用。 整个编织支架的端部被 处理定型为喇叭口状， 从而可提高编织支架端部的贴壁性。 图 3是本发明第三实施例的编织支架的侧视图，其中以放大图形式 显示了其中一股编织丝材通过显影丝被捆扎在一起的状态。 如图所示， 编织支架由 48根编织丝材构成。 48根编织丝材在支架端部被均匀地分 为 4股， 其中每股有 12根编织丝材， 这 12根编织丝材利用显影丝分别捆 扎固定在一起。 整个编织支架的端部被处理定型为喇叭口状， 从而可 提高其端部的贴壁性。 综上所述， 根据本发明， 编织支架根据其具体丝材根数 （如 24根、 32根、 48根、 64根、 72根、 96根等等） 的不同， 其支架丝材端部被分 为若干股 （如 3股、 4股、 6股、 8股等等） ， 其中每股丝材中的各根丝 材被固定在一起。 根据本发明， 每股丝材中的丝材根数可相同 （即均匀分配， 如 3 根一股， 4根一股等等） ， 也可不同； 整个编织支架端部可以为平直状， 也可为喇叭口状； 每股编织丝材端部可分别编织在一起， 或者未经编 织而直接被固定在一起。 根据本发明， 每股丝材端部的固定方式可以为： 通过直接编织并 热处理后固定在一起； 通过显影环将丝材端部固定在一起； 通过显影 丝在丝材端部缠绕而将丝材捆扎在一起； 使用生物胶水进行端部封堵 而固定在一起； 或者使用悍接方法进行固定。 显影环及显影丝由不透 X射线性能好、耐腐蚀性强、生物相容性好 的材料制成， 该材料可以是金、 铂、 钽、 锇、 铼、 钨、 铱、 铑等材料 或这些材料的合金。 通过显影环或显影丝在支架端部的固定及其在医 学影像设备下的显影， 可使医生更直观地辨识支架的位置及形态， 从 而方便医生进行操作。 根据本发明， 编织支架的端部丝材可采用分股编织的方式或者分 股直接用显影材料束缚的方式进行处理， 因而可依据需要来灵活选择 不同的设计， 有效防止支架端部丝材散乱， 提高支架贴壁性。 每股编 织丝材可根据需要选择不同数目的丝材组成。 端部编织丝材的束缚可 以选用可显影的材料， 以使支架的远端与近端在 X光下可视性良好， 方 便医生的操作与定位。 以上所述仅是本申请的一些具体实施方式。 应当指出， 对于本技 术领域的普通技术人员来说， 在不脱离本申请发明原理和发明构思的 前提下， 还可以做出若干改进和变型， 这些改进和变型也应视为落在 本申请的保护范围和发明构思之内。

Claims

权 利 要 求 书
1. 一种编织支架，该编织支架由多根丝材编织而成，其特征在于: 根据该编织支架的丝材根数， 该编织支架的端部的丝材被分为若 干股， 其中每股丝材中的各根丝材被固定在一起。
2. 根据权利要求 1所述的编织支架， 其特征在于：
每股丝材中的丝材根数是相同的， 或者是不同的。
3. 根据权利要求 1所述的编织支架， 其特征在于：
所述编织支架的整个支架端部为平直状， 或者为喇叭口状。
4. 根据权利要求 1〜3中任一项所述的编织支架， 其特征在于： 在该编织支架的端部， 每股丝材中的各根丝材被编织在一起， 或 者未经编织而直接被固定在一起。
5. 根据权利要求 1〜3中任一项所述的编织支架， 其特征在于： 在该编织支架的端部， 每股丝材中的各根丝材通过直接编织并热 处理而被固定在一起。
6. 根据权利要求 1〜3中任一项所述的编织支架， 其特征在于： 在该编织支架的端部， 每股丝材中的各根丝材通过显影环而被固 定在一起。
7. 根据权利要求 1〜3中任一项所述的编织支架， 其特征在于： 在该编织支架的端部， 每股丝材中的各根丝材通过显影丝在丝材 端部进行缠绕而被捆扎固定在一起。
8. 根据权利要求 1〜3中任一项所述的编织支架， 其特征在于： 在该编织支架的端部， 每股丝材中的各根丝材使用生物胶水进行 端部封堵而被固定在一起。
9. 根据权利要求 1〜3中任一项所述的编织支架， 其特征在于： 在该编织支架的端部， 每股丝材中的各根丝材使用悍接方法而被 固定在一起。
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