CN106510895A - Binding method for fixing duodenum stent to stent implantation instrument - Google Patents

Binding method for fixing duodenum stent to stent implantation instrument Download PDF

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Publication number
CN106510895A
CN106510895A CN201611067848.1A CN201611067848A CN106510895A CN 106510895 A CN106510895 A CN 106510895A CN 201611067848 A CN201611067848 A CN 201611067848A CN 106510895 A CN106510895 A CN 106510895A
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China
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stent
duodenal
bundle
cup
binding
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CN201611067848.1A
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Chinese (zh)
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范志宁
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常州新区佳森医用支架器械有限公司
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Priority to CN201611067848.1A priority Critical patent/CN106510895A/en
Priority to CN201510298007.0A priority patent/CN105055062A/en
Publication of CN106510895A publication Critical patent/CN106510895A/en

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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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • 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
    • 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-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
    • 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
    • A61F2002/045Stomach, intestines
    • 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A61F2002/9511Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
    • 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/001Figure-8-shaped, e.g. hourglass-shaped
    • 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
    • A61F2240/00Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001Designing or manufacturing processes

Abstract

Provided is a binding method for fixing a duodenum stent to a stent implantation instrument. The stent implantation instrument with a binding thread is sleeved with the duodenum stent, and then the stent is bound to the stent implantation instrument. The binding method comprises the steps that A, the binding thread is looped, the far end of the binding thread is pressed below the binding thread, the binding thread is wound around the duodenum stent, then the near end of the binding thread penetrates the loop and then is looped, the near end of the binding thread penetrates the loop again, and meanwhile the loop serves as a secondary new loop; B, the binding thread is wound outside the duodenum stent, then the near end of the binding thread penetrates the secondary new loop and is looped again to form a new loop, and the near end of the binding thread penetrates the secondary new loop again; C, the new loop obtained in the step B serves as a secondary new loop, the step B is executed, and the step D is executed after a string of loops is formed; and D, the last new loop is pressed through a pressing strip, and the binding thread penetrates a binding thread channel and penetrates out of the tail of the stent implantation instrument.

Description

将十二指肠支架固定于支架置入器械的捆绑方法 The method of binding is fixed to the duodenal stents Stent instrument

[0001] 本发明专利申请“将十二指肠支架固定于支架置入器械的捆绑方法”是申请日为:2015-06-03、申请号为:201510298007.0和发明创造名称为:十二指肠支架、制备方法、模具及支架置入器械和捆绑方法的分案申请。 "The method of the bundle is fixed to the duodenal stents of the stent device." [0001] The present patent application is filed: 2015-06-03, application number: 201510298007.0 and invention entitled: duodenum stent, preparation methods, and stent mold divisional application apparatus and method of the bundle.

技术领域 FIELD

[0002] 本发明涉及医疗器械的技术领域,尤其涉及一种十二指肠支架、制备方法及支架置入器具和支架固定方法。 [0002] Technical Field The present invention relates to medical devices, particularly to a duodenal stents, stent implantation, and method for preparing equipment and stent fixation.

背景技术 Background technique

[0003]目前,提出的十二指肠支架基本上由两部分构成,起定位作用的金属构件和起隔离作用(隔离食糜与消化液)的套管。 [0003] Currently, duodenal stents proposed consists essentially of two parts, the metal member functions as a positioning and provides isolation function (isolation and digestive chyme) sleeve. 本发明提出的十二指肠支架如图1所示,也是由固定件和套管构成。 Duodenal stents made according to the invention shown in Figure 1, is composed of a fixed member and the sleeve. 与现有提出的用金属圆环或椭圆形的金属圈定位作用相比,本发明设计了酒杯形金属网状支架作为定位构件,见图4,它不仅能可靠的定位,还具有密封作用,而且对幽门的收缩功能基本上无影响。 Compared with the effect of a metal collar or ring oval metal prior proposed design of the present invention the cup-shaped metal mesh stent as a positioning member, shown in Figure 4, it can not only reliable positioning, but also has a sealing effect, and essentially no effect on the contractile function of the pylorus. 杯身和杯底的夹持作用,实现了可靠的定位作用;杯底边缘向杯身翘起外缘45和其上的高分子材料裙边3的设计,使它与胃的幽门前区贴合严密,以防食糜漏入十二指肠支架的套管外;酒杯杯柄的设计,使之处于胃的幽门处;而杯柄恰当的螺旋线导程的选取,调整了杯柄的径向支撑力,从而对幽门的收缩功能的影响减至最小。 Clamping action of the cup body and the bottom of the cup, to achieve reliable positioning effect; cup base 45 and on which the lifting edge to the outer edge of the cup skirt and body 3 of a polymer material, and attached to it before pyloric region of the stomach close together, to prevent leakage into the outer sleeve duodenal digesta stent; Tumblers handle design, so that in the pylorus of the stomach; cup holder and selecting the appropriate lead of the helix, the diameter of the cup holder adjusted the supporting force, thus affecting the function of the pylorus contraction minimized. 十二指肠支架有一个较长的高分子材料的套管,要把又长又软的套管置入人体消化道,大大的增加了整个支架置入操作的难度和置入器械的复杂性。 Duodenal stents have a longer sleeve polymer material, put into long soft cannula human digestive tract, greatly increase the complexity of the overall operation of the difficulty and stent placement instrument . 本发明设计出单线或双线两端捆绑输送法、单线或双线轴向套叠捆绑输送法和单线或双线轴向折叠捆绑输送法,不但置入器械简单,而且操作容易。 The present invention contemplates a double-line or both ends of the bundle delivery method, a single or double telescopic axial bundle delivery method and single or double folded axially bundle conveyance method, not only into the device simple and easy to operate. 因而,不论是十二指肠支架还是相应的置入器械,本发明的特点是简单、可靠和实用。 Thus, whether or duodenal stents into the corresponding instrument, the characteristics of the present invention are simple, reliable and practical.

发明内容 SUMMARY

[0004] 本发明提供一种具有定位和固紧功能的十二指肠支架、制备方法、模具及支架置入器械和捆绑方法,能够有效阻断小肠对食物的消化吸收,并从源头上减少糖份的吸收。 Duodenal stents [0004] The present invention provides a positioning and a fastening function, preparing the mold or stent implantation apparatus and method for bundling, can effectively block the intestinal digestion and absorption of food, and to reduce the source sugar absorption.

[0005] 本发明采用如下技术方案: [0005] The present invention adopts the following technical solution:

本发明所述的一种十二指肠支架,包括酒杯形金属网状支架,在酒杯形金属网状支架上连接有高分子材料套管。 One kind of duodenal stents according to the present invention, comprises a cup-shaped metal mesh stent, a metal mesh on a goblet-shaped bracket connected to the sleeve polymer material.

[0006] 本发明所述的一种十二指肠支架的制备方法,包括以下步骤: [0006] The method for producing a duodenal stents according to the present invention, comprising the steps of:

步骤I制备圆形金属网管 Step I Preparation of a circular metal mesh

步骤II,取一根金属丝,将金属丝绕制成第一段螺旋线且所述第一段螺旋线的轴向长度与酒杯形网状支架的杯底圆盘径向尺寸相对应,加大导程并继续绕制出第二段螺旋线,第二段螺旋线的轴向长度与酒杯形网状支架的杯柄高度相对应,减小导程并继续绕制第三段螺旋线,第三段螺旋线的长度与酒杯形网状支架的杯身高度相对应, Step II, take a wire, the wire is wound in a bottom of the cup disk radial dimension and axial length of the first section of the first segment helix with helix-shaped glass mesh stent corresponds added large lead and the second segment to continue the spiral winding, the height of the axial length of the second segment cup stem and goblet-shaped spiral mesh stent corresponding to reduce lead and a third segment continuing spiral wound, the length of the third segment helix mesh stent goblet-shaped body corresponding to the height of the cup,

步骤1.2在步骤1.1所述第三段螺旋线的末端折弯金属丝,并将金属丝朝向起始端继续绕制第四段螺旋线且所述第四段螺旋线的长度与酒杯形网状支架的杯身高度相对应,所述第四段螺旋线与所述第三段螺旋线交叉形成杯身交叉点,构成任意相邻两个杯身交叉点中的一个杯身交叉点的第四段螺旋线从所述第三段螺旋线下方穿过,构成任意相邻两个杯身交叉点中的另一个杯身交叉点的第四段螺旋线从所述第三段螺旋线上方穿过压过;加大导程并接着绕制第五段螺旋线,第五段螺旋线的轴向长度与酒杯形网状支架的杯柄高度相对应,所述第五段螺旋线与所述第二段螺旋线交叉形成杯柄交叉点,构成任意相邻两个杯柄交叉点中的一个杯柄交叉点的第五段螺旋线从所述第二段螺旋线下方穿过,构成任意相邻两个杯柄交叉点中的另一个杯柄交叉点的第五段螺旋线 Step 1.2 at the end of the third segment of the spiral wire bending step 1.1, and continue to the starting end toward the wire wound helix fourth segment and the fourth segment of the length of the spiral-shaped glass Wallstent corresponding to the height of the cup body, a cup body with spiral fourth segment intersection lines crossing the third section spiral form, constituting a fourth segment of any adjacent two intersections mug cup body intersecting points of from below through the spiral helix third section, constituting any adjacent two intersections another mug cup body crossing points through the fourth paragraph spiral helix pressure from said third party through; and then increase the lead helix wound in the fifth paragraph, the fifth paragraph of the axial length of the height of the stem cup helix and goblet-shaped mesh stent corresponding to the fifth paragraph of the second helix helix cross section intersections formed cup holder, a cup holder constituting any adjacent two intersections in the intersections of the cup handle in the fifth paragraph of the second section helix from below through the spiral, in which arbitrary two adjacent another cup holder cups handle intersections in the fifth paragraph of intersection helix 所述第二段螺旋线上方穿过压过;减小导程并接着绕制第六段螺旋线,第六段螺旋线的轴向长度与酒杯形网状支架的杯底圆盘的径向尺寸相对应,所述第六段螺旋线与所述第一段螺旋线交叉形成杯底交叉点, 构成任意相邻两个杯底交叉点中的一个杯底交叉点的第六段螺旋线从所述第一段螺旋线下方穿过,构成任意相邻两个杯底交叉点中的另一个杯底交叉点的第六段螺旋线从所述第一段螺旋线上方穿过压过;步骤1.3在步骤1.2所述第六段螺旋线的末端折弯金属丝,并重复步骤1.1和步骤1.2 直至形成圆形金属网管;步骤2对圆形金属网管进行定形处理将圆形金属网管套在酒杯形状的定形模具上,使之具有设计的酒杯形状和尺寸,再将酒杯形金属网管连同酒杯形状的定形模具一起置于420~510°C温度环境中20~50分钟,然后水冷,卸下定形模具,得到酒杯形网状 The second segment coil side through the pressure line therethrough; and then reducing the lead spiral wound, sixth paragraph, the axial length of the radial bottom of the cup disk with the sixth paragraph of the helix-shaped glass mesh stent corresponding to the size, the segments of the first segment and the sixth spiral coil formed cup base lines crossing intersections, constituting any adjacent a bottom of the cup, sixth paragraph helix intersection of two crossing points from the bottom of the cup the first section through the spiral downward, the sixth segment constituting any adjacent another spiral cup base cup bottom two intersection points of intersection from the first section through the pressure line side through the coil; step 1.3 bent at the end of the sixth paragraph of the helix wire step 1.2, step and repeat steps 1.1 and 1.2 until a circular metal mesh is formed; step 2 for circular metal mesh setting process sets a circular metal mesh in the glass upper shaping mold shape, so as to have a shape and size of the design glass, then the glass network-shaped metal shaping die along with the shape of the glass was placed with 420 ~ 510 ° C temperature environment for 20 to 50 minutes, then cooled, remove amorphous mold, goblet-shaped mesh to give 架;步骤3在酒杯形网状支架上连接套管,得到十二指肠支架。 Frame; Step 3 is connected to the sleeve-shaped glass mesh stent, duodenal stents obtained.

[0007] 本发明所述的一种用于所述制备方法的模具,包括:螺栓,在螺栓上依次套设有第一圆芯管、第二圆芯管和第三圆芯管且由设在螺栓两端的螺帽固紧,在第一圆芯管、第二圆芯管和第三圆芯管上设有螺旋形凹槽,所述螺旋形凹槽始于第一圆芯管的外端,延伸至第三圆芯管的外端折返并转换成反向螺旋形凹槽,延伸至第一圆芯管的外端,以此反复延伸直至形成螺旋形凹槽网,并且位于第二圆芯管上的螺旋形凹槽的螺旋导程大于第一圆芯管和第三圆芯管,所述第一圆芯管的长度与酒杯形网状支架的杯底圆盘径向尺寸相对应,第二圆芯管的长度与酒杯形网状支架的杯柄高度相对应,第三圆芯管的长度与酒杯形网状支架的杯身高度相对应。 [0007] A method of preparing the mold for the present invention comprises: a bolt, the bolt is provided with a first set of sequentially round the core tube, the second circle and the third circle core tube and core tube is provided by the in both ends of the nut bolts secured in the first round the core tube, provided with a helical groove on the second circle and the third circle core tube core tube, the spiral outer groove of the first round begins with the core tube end, extends to the third circle of the core tube and an outer end of the folded converted into reverse helical groove extends to the outer end of the first round the core tube, thereby extending repeated until a helical groove network, and in the second helical grooves on the core tube circle screw lead greater than the first circle and the third circle core tube core tube, core tube length of the first circle and the glass bottom of the cup-shaped mesh stent radial dimension relative to the disc Cup-shaped glass height and length of the corresponding mesh stent, a second circle corresponding to the core tube, the length of the third circle glass core tube shaped mesh stent corresponding to the height of the cup body.

[0008] 本发明所述的一种十二指肠支架的支架置入器械,包括:芯管且芯管用于承载所述十二指肠支架,在芯管的芯管壁上设有第一捆绑线通道和第一支架捆绑线窗口,在第一捆绑线通道内设有用于固定捆扎所述十二指肠支架的第一捆绑线。 [0008] The stent according to one kind of duodenal stent placement apparatus of the present invention, comprising: a core tube and core tube for carrying the duodenal stents, the core is provided with a first wall of the core tube a first bracket and a wire channel bundle bundling window, where the first binding site for a first wire channel bundle tying wire fixing bracket of the duodenum.

[0009] 本发明所述的一种将十二指肠支架固定于支架置入器械的捆绑方法,将十二指肠支架套在已设置了捆绑线的支架置入器械上,再用十二指肠支架捆绑方法将十二指肠支架捆绑于支架置入器械上,所述的十二指肠支架捆绑方法包括以下步骤:步骤A:将捆绑线绕成圈且捆绑线的远端被压在捆绑线的下方,再将捆绑线在十二指肠支架的外部环绕,然后将捆绑线的近端穿过所述圈后再绕一个环并将捆绑线的近端再次穿过所述圈,同时将所述环当作次新环,步骤B:将捆绑线在十二指肠支架的外部再进行环绕,然后将捆绑线的近端穿过所述次新环后再绕一个新环并将捆绑线的近端再次穿过所述次新环, [0009] A according to the present invention is fixed to the duodenal stents stent instrument binding method, duodenal stent sleeve has been provided on the holder device into the line bundle, then twelve the method of bundling the duodenum stent duodenal stents tied to the stent device, duodenal stents bundling said method comprising the following steps: step a: a wound bundle into a bundle and the distal end wire ring is pressed below the line bundle, then the wire around the bundle in the cradle outside the duodenum, and then the proximal end of the wire bundle after passing through said ring and around a ring binder thread passes again through the proximal end of the ring while the second new ring as ring, step B: a bundle around the outside line then duodenal stents, and the proximal end of the wire bundle passing through the secondary winding of the new ring before a new ring and the proximal end of the wire bundle passing through the second new loop again,

步骤C:将步骤B得到的新环当作次新环,返回步骤B,在形成一串环后进入步骤D, Step C: Step B as a new ring views of the new ring, is returned to step B, proceeds to step D after formation of the string loop,

步骤D:用压条将最后一个新环压住,再将捆绑线穿过捆绑线通道并从支架置入器械的尾部穿出。 Step D: Finally, a new ring pressed with a press bar, and then through the line bundle bundled cable passage and from the tail of the instrument piercing stent.

[0010]与现有技术相比,本发明具有如下优点: [0010] Compared with the prior art, the present invention has the following advantages:

Cl)本发明有效阻断小肠对食物的消化吸收,与胃粘膜紧密地、服帖地接触,并能保持幽门的收缩功能。 Cl) of the present invention effectively block the intestinal absorption of food digestion, tightly, docile contact with the gastric mucosa, and to maintain contractile function pylorus.

[0011] 本发明的十二指肠支架置入胃和十二指肠内,参照图7,起始于胃100的幽门4,覆盖与幽门4相连接的部分十二指肠段或全部十二指肠段101,是以酒杯形网状支架和套管,特别是以套管实施阻隔,胃内的消化物一一食糜经过十二指肠时,仅部分的或完全不与十二指肠内壁接触,从而减少甚至完全排除十二指肠的消化和吸收作用,有效阻断小肠对食物的消化吸收,并从源头上减少糖份的吸收。 [0011] The present invention duodenal stents into the stomach and duodenum, with reference to FIG. 7, the starting 4 100 pyloric stomach, pyloric covering portion 4 is connected to the duodenum or all ten intestines finger 101, are goblet-shaped mesh stent and the sleeve, in particular in the barrier sleeve embodiment, the stomach digests of eleven chyme passes through the duodenum, entirely or only partially with twelve means contacting the intestinal wall, thus reducing or even completely eliminate digestion and absorption in the duodenum, the small intestine digestion effectively blocking absorption of food, and to reduce the absorption of sugar from the source.

[0012] 十二指肠支架与胃幽门处的胃粘膜紧密接触,使得胃消化物(食物)基本上都通过支架向十二指肠或空肠排出。 [0012] close contact with the gastric duodenal stents gastric pylorus, stomach digests such that the (food) substantially through the stent is discharged to the duodenum or jejunum. 十二指肠支架定形处理时,产生一定的弹性力,使十二指肠支架的近端杯底圆盘紧密地、服帖地轻轻压在胃的粘膜上。 When duodenal stents setting treatment, a certain elastic force, so that the proximal end of the cup bottom are closely disk duodenal stents, docile gently pressed against the stomach mucosa. 为实现上述功能,金属支架设计成酒杯状,杯底圆盘是支架的近端(所谓近端和远端,是相对操作者而言:一个器件靠近操作者的一端为近端,远离操作者的另一端为远端)置于胃内,为了使其与胃粘膜紧密地、服帖地接触,杯底圆盘外缘向上(向杯身方向)稍稍翘起形成弯折边45,且杯底圆盘与胃粘膜接触一侧有一层高分子薄膜构成的裙边3,这层高分子薄膜沿杯柄一直延伸至杯身,与十二指肠套管相连。 To achieve the above functions, the metal stent is designed to shape the glass, the cup bottom disc is the proximal end of the stent (the so-called proximal and distal ends relative to the operator is concerned: a device near the proximal end of the operator, away from the operator the distal end of the other end) is placed in the stomach, in order to make, docile close contact with the gastric mucosa, the outer edge of the disk bottom of the cup upward (the direction of the cup body) tilt slightly bent edge 45 is formed, and the bottom of the cup gastric disc in contact with one side of the skirt layer of polymer thin film 3, a polymer film layer which extends along the shank cup body to the cup, the sleeve is connected to the duodenum.

[0013] 酒杯形网状支架的杯柄正好置于幽门处,杯柄长度与幽门的宽度相对应,杯柄金属支架螺旋线的导程相对较大,因而,杯柄的径向支撑力较小,也就是说杯柄部金属支架对幽门的径向支撑作用很小,从而使幽门仍然保持其收缩功能,对幽门生理功能的影响显着减少。 [0013] Cup-shaped glass mesh stent is placed exactly the pylorus, cup stem width corresponding to the length of the pylorus, cup stem metal stent helix lead is relatively large, and therefore, radial strength than the cup holder small, that is to say radially acting supporting the cup holder pylorus metal shank is very small, so that the contractile function remains pylori, H. Effect of physiological function is significantly reduced. 杯身是金属支架的远端,则置于十二指肠的球部,一方面与十二指肠球部紧密接触,另一方面杯身与高分子材料套管的结合强度高。 The distal end of the stent is a metal cup body, the duodenal bulb is placed, on the one hand in close contact with the duodenal portion, on the other hand a high bonding strength with the glass body of the sleeve polymer material. 金属支架上的高分子薄膜与套管也可以做成整体式的。 Polymer film and the metal support sleeve can also be made unitary.

[0014] (2)本发明的十二指肠支架制备方法的作用和效果如下: [0014] (2) Operation and Effect duodenal preparation stent of the present invention is as follows:

按照本发明圆形金属网管的绕制方法绕制,可形成两组螺旋线,其中一组为左旋,另一组为右旋,两组螺旋线相互活动交叉,构成许多小菱形网格。 According to the present invention is a circular metallic NMS wound winding method, two sets of spiral may be formed, wherein a set of left-handed, the other group is right-handed, two spiral intersect each other activities, many small diamond-shaped mesh configuration. 确切地说,相邻两根左旋螺旋线和相邻两根右旋螺旋线相互交叉,构成小的菱形网格单元,整个圆形金属网管完全由这些小菱形网格单元所构成。 Specifically, two adjacent left-handed helix right-handed helix and the adjacent two intersecting each other to form a small diamond-shaped grid cells, the entire circular metal mesh entirely constituted by these small diamond grid cells. 沿圆周方向排列的一组菱形网格单元,其顶点分别位于三个彼此相邻的圆周上,支架编织组合模具每一段的端部,也都位于这两组左右旋螺旋线的交叉点所构成的圆周上,见图6。 A set of diamond-shaped grid cells arranged in the circumferential direction, its apex located adjacent to each other on three peripheral, end bracket woven split molds of each section, the two sets are also located around the intersection constituting the rotating helix on the circumference, see Fig. 金属网状支架各段采用不同的导程λ,使近端段的圆盘具有高的抗弯曲弹性,中段具有较低的径向支撑力,远端段具有较高的径向支撑力,因而,远端段杯身的螺旋线导程最小,中间段杯柄部的导程最大,近端段杯底的导程居中。 Metal mesh stent segments with different lead [lambda], the proximal segment of the disk having a high resistance to bending elasticity, the middle has a lower radial strength, a distal segment having a high radial strength, so , the distal section of the cup body smallest helix lead, the lead portion of the intermediate section maximum cup holder, the lead proximal segment centered bottom of the cup.

[0015] 按照本发明绕制方法绕制的圆形金属网管,螺旋线不重复。 [0015] The method according to the present invention winding wound round a wire mesh tube, the spiral will not be repeated.

[0016] 按照本发明绕制方法绕制的圆形金属网管,其两组螺旋线相互活动交叉。 [0016] The metal mesh wound round the winding method according to the present invention, two sets of spirals which intersect each other activities.

[0017] 当一根左旋或右旋螺旋线,与另一组右旋或左旋平行的螺旋线相交叉时,沿这一根左旋或右旋螺旋线上相邻的交叉点,此左旋或右旋螺旋线处于另一组右旋或左旋平行的螺旋线上位和下位是相间的,也就是说,如这一根左旋或右旋螺旋线在一个交叉点是从上面通过另一组右旋或左旋平行的螺旋线时,则通过下一个交叉点时,在另一组右旋或左旋平行的螺旋线的下面,参照图5。 [0017] When a right-handed or left-handed helix, and another set of left-handed or right-handed helix intersecting parallel, along which a right-handed or left-handed helix adjacent the intersection, the left or right rotating helix is ​​right-handed or another set of bits and the lower helix is ​​left-handed parallel phases, i.e., such that a right-handed or left-handed helix at an intersection from above or through another set of right-handed when left-handed helix parallel, then through the next intersection, under another set of left-handed or right-handed helix in parallel, with reference to FIG. 在这些交叉点,不同走向的两根N1-Ti形状记忆合金丝仅互相交叉,在支架发生变形时,这两根丝可以产生相对位移,因而,这些交叉点都是活结点。 In these intersections, two N1-Ti shape memory alloy wire to a different cross each other only when the stent is deformed, which may produce a relative displacement of the two wires, therefore, these intersections are points slipknot. 编织完成时,这根N1-Ti形状记忆合金丝的两个端头将重叠在一起,端头重叠的位置一般应位于支架的中部。 When the weaving is completed, the two ends of the root of N1-Ti shape memory alloy wire will overlap, the overlapping ends of the stent should be located in a position generally in the middle. [〇〇18] 支架的定形处理后,支架具有记忆成品支架形状和尺寸的功能,即当支架处于约束状态或压缩状态时,它具有自膨胀能力。 [〇〇18] After setting processing stent, the stent having a memory function shape and size of finished stent, i.e., when the stent is constrained state or a compressed state, having a self-expanding capability.

[0019] (3)本发明用于制备圆形金属网管的模具具有如下优点:采用图6所示的分段的组合编织模具,在螺旋线的头数相同时,各段模具根据需要可以选取不同的导程,因而,各段编织出的支架具有不同大小的菱形网格,也就具有不同的力学性能:各段支架具有不同的径向支撑力和不同的轴向抗弯强度。 [0019] (3) preparing a mold according to the present invention for a circular metal mesh has the following advantages: using the segment shown in FIG. 6 knitting mold combination, the number of the first spiral are the same, each mold section may be selected as required different lead, therefore, each segment of the stent has a braided mesh diamond of different sizes, also have different mechanical properties: the stent having segments of different radial strength and different axial flexural strength.

[0020] (4)本发明的支架置入器械在十二指肠支架置入完毕后能够方便、可靠的实现回撤。 After [0020] (4) into the stent device of the present invention in the duodenum finished stent can be easily, reliably realized retracement.

[0021] 芯管的主腔84上加工有径向排液孔88,见图8,以便撤回支架置入器械时,从手柄注液孔注入蒸馏水,流入支架套管与支架置入器械之间的间隙,在注入蒸馏水时,边回撤支架置入器械,边左右旋转支架置入器械,以防支架的套管包裹在支架置入器械上,影响支架置入器械从支架套管中退出。 The main chamber 84 [0021] Processing core tube radial drain hole 88, while Figure 8, to withdraw the stent device, distilled water is injected from the injection hole of the handle, and flows into the stent cannula stent between the instrument gap during injection distilled water were retracement stent placement instrument while rotating around stent device, the sleeve wrap to prevent the stent of the stent device, stent implantation cannula instrument withdrawn from the housing.

[0022] (5)本发明所述的十二指肠支架的捆绑方法支架输送方式采用支架捆绑释放方法,首先将整个十二指肠支架均匀地套在支架置入器械上,再用捆绑线将十二指肠支架的远端和近端捆绑住,使十二指肠支架固定在输送装置上。 [0022] (5) The method of bundling duodenal stents according to the present invention using a stent delivery stent embodiment bundled delivery method, the entire first bracket uniformly duodenal stent fitted over the device, and then bundled wire the distal and proximal duodenum tied down the stent, the stent is fixed to the duodenal delivery device. 支架置入器械连同支架插入到位后,抽拉支架置入器械尾部是捆绑线,即可拆散绳结,释放支架。 Together with the stent after stent insertion instrument in place, stent placement instrument pull the tail line is tied, the knot can break up, release the stent. 抽拉捆绑线拆散绳结的原理见图15。 Principle drawing line break tied the knot in Figure 15.

[0023] 支架安装时,将支架套在置入器械的芯管上,支架套管的远端紧挨着软头的近端。 [0023] When the bracket is mounted, the stent is placed on the instrument sleeve core tube, the distal end of the stent proximal end of the soft cannula head immediately. 捆绑时,仅捆绑十二指肠支架的两端,即只捆绑支架的远端和近端,其余部分的支架套管处于非捆绑状态。 When tied, bundled ends duodenal stents only, i.e., only the distal and proximal bundle stent, the stent is in the rest of the sleeve unbundled state. 支架远端捆绑的作用是固定十二指肠支架套管在置入器械上的位置,防止套管在置入器械芯管上发生滑动,因而,捆绑线的圈数尽可能少,通常1〜5圈;而支架近端捆绑的作用,不仅是固定支架与置入器械的相对位置,而且要把金属网管支架服帖地捆绑住, 便于置入器械插入消化道。 The distal end of the stent is the role of bundling duodenal stents stationary sleeve placed on the instrument, to prevent the sliding sleeve into place on the core instrument tube, thus, the number of turns of the wire bundle as little as possible, typically 1 ~ circle 5; and the proximal end of the stent bundled role, not only is the relative position of the mounting bracket into the device, and metal mesh stents should docile tied down, easy to insert the instrument into the digestive tract. 此时,捆绑圈数较多,捆绑线圈均匀的分布在金属网管支架的表面上。 In this case, the number of turns larger bundle, evenly distributed on the surface of metal mesh coil stent of the bundle. 十二指肠支架捆绑在置入器械的远端,支架远端的捆绑线一一第一支架捆绑线87,经由芯管内的第一支架捆绑线通道851,从芯管远端的第一支架捆绑线窗口(82)穿出,按图13 的捆绑方法,将支架套管的远端捆绑1〜5圈,绳结的拆散顺序为由近及远;支架近端的捆绑线一一第二支架捆绑线86,经由芯管的第二支架捆绑线通道852,由芯管上第二支架捆绑线窗口(83)穿出,用同样的捆绑方法将支架的近端捆绑住,确保金属支架部分服帖的捆绑在置入器械上,而绳结的拆散顺序则为由远及近。 Duodenal stents into the distal end of the instrument tied, bundled distal end of the stent wire bundling eleven lines 87 of the first bracket, the first bracket bundled via wire channels 851 in the core tube, core tube from the distal end of the first bracket bundling window line (82) piercing, according to the method of FIG. 13 bundle, the distal end of the stent cannula ~ 5 binding ring, knot break sequence by near and far; the stent proximal end of the eleven second wire bundle wire bundle holder 86, second holder via the bundled wire channel 852 of the core tube, core tube by the second piercing stent wire bundling window (83), using the same method bundle tied down stent proximal end, ensure that the metal bracket portion docile bundle placed on the instrument, and the order of the knot was disassembled from far and near. 第一、二捆绑线的尾端由置入器械的手柄尾管穿出,释放支架时,先抽拉第二支架捆绑线,释放支架的近端;当支架近端——金属支架部分定位妥当后,再抽拉第一支架捆绑线,释放支架的远端。 First, two tail pipes piercing the wire bundle into the handle end of the instrument, when the stent is released, to pull the second wire bundle holder, releasing the proximal end of the stent; when the proximal end of the stent - metal bracket portion is positioned properly after then pulling the first wire bundle holder, releasing the distal end of the stent. 我们将这种捆绑方法称为双线两端捆绑法,十二指肠支架在置入器械上的位置见图13。 We refer to this method is called a two-wire bundle ends bundling method, duodenal stents position on the placement of the instrument shown in Figure 13.

[0024] 为了缩短支架在支架置入器械上的包覆长度,较长的套管可以采用轴向套叠或轴向折叠的方法,见图15和图16。 [0024] In order to shorten the length of the stent coating on the stent device, a long sleeve axially nested methods may be employed or axially folded, see Figure 15 and 16. 当套管采用轴向套叠或轴向折叠的输送方式时,也是支架的远端和近端分别捆绑,远端同样仅捆绑I〜5圈,但近端的捆绑圈数应将轴向套叠或折叠后的支架要完全被捆绑线捆绑住,确保整个十二指肠支架服帖地包覆在输送装置上,不会影响带有十二指肠支架的输送装置插入人体消化道。 When sleeving is conveyed axially or axially nested folding, the stent is a distal end and a proximal end of the bundle, respectively, only the distal end of the same bundle I~5 circle, but the number of turns of the proximal end of the bundle should axial sleeve stacked or folded stent is completely tied to the live wire tied, duodenal stents docile ensure that the entire coating on the conveying means, the conveying means will not affect the duodenal stents inserted with the human digestive tract. 套管轴向套叠或轴向折叠后再捆绑在输送装置上的输送方式,分别称为双线轴向套叠捆绑输送法和双线轴向折叠捆绑输送法。 Sleeve axially or axially nested bundle conveyed after the folding manner on the conveying means, called telescopically axially wire bundle delivery method and delivery method bundled wire axially folded. 这两种捆绑输送方法支架的捆绑顺序和释放顺序与双线两端捆绑法相同。 Both binding sequence binding and release of the stent delivery methods and order wire bundle ends the same method.

[0025] 也可以用一根捆绑线实现十二指肠支架的两端捆绑。 [0025] can also be used to achieve a bundling cable bundle ends duodenal stents. 此时,置入器的芯管采用双腔管,见图10,捆绑线87由第一捆绑线窗口82抽出来捆绑十二指肠支架的远端,捆绑线再由第二捆绑线窗口抽出,捆绑十二指肠支架的近端,近端捆绑完毕后捆绑线再穿入第二捆绑线窗口,经芯管8的副腔851,由手柄的尾管94穿出。 At this time, the core tube is placed double-lumen tube shown in Figure 10, the bundled wires 87 out the distal end of the duodenum tied to the stent by the first wire bundling window 82, and then drawn by a second wire bundle bundling window line , the proximal duodenum tied stent, the proximal end of the finished bundle bundled wire line rethread second bundling window, through the core tube of the sub-chamber 8518, piercing the tail pipe 94 of the handle.

附图说明 BRIEF DESCRIPTION

[0026]图1是本发明十二指肠支架的结构示意图,图中I一酒杯形金属网状支架,2—高分子材料套管。 [0026] FIG. 1 is a structural diagram of the present invention, duodenal stents, goblet-shaped figure I a metal mesh stent, 2- polymer material sleeve.

[0027]图2是本发明十二指肠支架的局部放大示意图,显示十二指肠支架与与胃幽门的相互关系,图中I一酒杯形金属网状支架,2—套管,4一胃幽门。 [0027] FIG. 2 is a partially enlarged duodenal stents of the present invention is a schematic diagram showing the relationship between the pyloric and duodenal stents, and FIG. I a goblet-shaped metal mesh stent, 2- sleeve, a 4 pyloric.

[0028]图3是本发明十二指肠支架的局部B放大示意图,显示金属支架近端杯底圆盘的密封作用。 [0028] FIG. 3 is a partial duodenal stents of the present invention B enlarged schematic illustration showing the proximal end of the sealing action of the metal bottom of the cup holder disc. 图中,3—裙边,4一胃幽门,45—杯底圆盘的弯折边。 FIG, 3 skirt 4 a pyloric, 45- cup bottom edge of the disc bent.

[0029]图4是本发明酒杯形网状支架结构示意图。 [0029] FIG. 4 is a schematic view of a mesh-shaped supporting structure glasses present invention.

[0030]图5是本发明酒杯形网状支架局部A结构示意图,即图4中局部A的放大图,显示支架编织结构的特征。 [0030] FIG. 5 is a schematic partial structure A goblet-shaped mesh stent of the present invention, i.e., a partial enlarged view of FIG. 4 A, the display characteristics of the stent woven structure.

[0031]图6是本发明用的组合编织模具结构图。 [0031] FIG 6 is a combination of knit structure of the mold used in the present invention. 图中,61—编织杯底的圆筒形模具,62—编织杯柄的圆筒模具,63—编织杯身的圆筒模具,64—垫片,65—螺栓,66—螺帽。 Drawing, weaving 61- cylindrical mold bottom of the cup, the cylindrical mold cup holder woven 62-, 63- braided cylindrical cup body mold, 64- gaskets, bolts 65, nuts 66-.

[0032]图7是十二指肠支架置入人体腔道后的位置,图中I 一酒杯形金属网状支架,2—高分子材料套管,4 一幽门,100—胃,101—十二指肠。 [0032] FIG. 7 is a duodenal stent placement position of the body cavity, FIG. I a goblet-shaped metal mesh stent, 2- polymer material sleeve, a 4 pylorus, stomach 100, 101 ten duodenum.

[0033]图8是本发明制做高分子材料套管的玻璃模具,金属网状支架套在玻璃模具上,经在高分子材料乳液中浸提及随后的硫化,形成与金属网管支架上的薄膜一体化的套管。 [0033] FIG. 8 of the present invention is a polymer material making glass mold sleeve, a metal mesh stent fitted over the glass mold, by reference to the subsequent vulcanization immersed in the emulsion polymer material, is formed on a metal mesh stent film-integrated sleeve. 图中,I一金属网管支架,2—套管,5—玻璃模具。 Figure, the I a metal mesh stent, the sleeve 2-, 5- glass mold.

[0034]图9是本发明支架置入器械的一个实施例结构图一一十二指肠支架三腔管捆绑置入器械,图中,81—软头,82—第一支架捆绑线窗口,83—第二支架捆绑线窗口,851—第一拥绑线通道,852—第二拥绑线通道,86—第二拥绑线,87—第一拥绑线,9 一手柄,91 一鲁尔接头,92—密封盖,94 一第一尾管,95—第二尾管。 [0034] FIG. 9 of the present invention is a stent placement apparatus of one embodiment of a configuration diagram of duodenal stents eleven three-cavity tube bundle placed in the instrument, drawing, soft head 81-, 82- wire bundling window first bracket, 83- second holder line bundling window, the first hold tie wire channels 851-, 852- second hold tie wire passage, a second hold tie lines 86-, 87- hold the first tie line, 9 a handle, 91 a Lu luer lock, 92- sealing cover, a first tail tube 94, 95- second tailpipe.

[0035]图10是图9芯管CC剖面的放大图,展示三腔管的结构特征,图中,84—芯管主腔,851—第一捆绑线通道(芯管副腔),852—第二捆绑线通道(芯管副腔)。 [0035] FIG. 10 is an enlarged view of the core tube CC cross section, showing the structural features of triple lumen tube, drawing, core tube main chamber 84-, 851- first binding wire channel (sub-chamber core tube), 852- the second wire channel bundle (core tube subchamber).

[0036]图11是图9芯管DD剖面的放大图,图中,84——三腔管主腔,851——三腔管副腔(第一捆绑线通道),88—一排液孔。 [0036] FIG. 11 is an enlarged view of the cross-section DD of the core tube 9, FIG, 84-- lumen three main chamber, the secondary chamber 851-- three lumen (first wire channels bundled), a drain hole 88 .

[0037]图12是本发明的支架置入器械的另一个实施例的结构图一一十二指肠支架双腔捆绑置入器械。 Structure of FIG. [0037] FIG. 12 is a stent according to the present invention is placed into the instrument with another embodiment of the dual-chamber bundling eleven duodenal stents placement instrument.

[0038]图13是图12上FF剖面的放大图。 [0038] FIG. 13 is a view on an enlarged sectional view in FIG. 12 FF.

[0039] 图14是本发明十二指肠支架在置入器械上的捆绑位置示意图。 [0039] FIG. 14 is a schematic view of the bracket in the fastening position into the instrument of the present invention duodenum.

[0040] 图15是抽拉捆绑线拆散绳结的原理图,图中,7—压线圈,71——次绳圈,72—二次绳圈,8—芯管。 [0040] FIG. 15 is a drawing tied knot break line diagram, FIG, 7-voltage coil, 71-- views ropes, ropes secondary 72-, 8- core tube.

[0041] 图16是本发明十二指肠支架套管轴向套叠示意图。 [0041] FIG. 16 is a schematic view of the present invention duodenum telescoping sleeve holder axially.

[0042] 图17是本发明十二指肠支架套管轴向折叠示意图。 [0042] FIG. 17 is a schematic view of the present invention, the stent is folded axially duodenal cannula. 具体实施方式[〇〇43]实施例1-十二指肠支架参照图1,一种十二指肠支架,包括酒杯形网状支架1,在酒杯形网状支架1上连接有套管2,所述酒杯形网状支架1包括杯底41、杯身43和用于连接杯底、杯身的杯柄42,参照图3和图4,所述杯底边缘向杯身翘起并形成弯折边45,所述酒杯形网状支架1由呈左螺旋线形状的金属丝状物和呈右螺旋线形状的金属丝状物交叉编织构成,通常,金属丝状物采用N1-Ti 形状记忆合金丝,参照图2,构成杯柄部分的金属丝状物的螺旋线导程大于构成杯底和杯身部分的金属丝状物的螺旋线导,并且,构成杯柄部分的金属丝状物的螺旋线导程为60~ 145mm,构成杯底部分的金属丝状物的螺旋线导程为55〜100mm,构成杯身部分的金属丝状物的螺旋线导程为40~85mm,由此使得酒杯形网状支架1的杯柄42具有弹性变形能力,参照图4,在酒杯形网状支架1上覆盖 DETAILED DESCRIPTION [〇〇43] Embodiment 1 A duodenal stents Referring to FIG Example 1- duodenal stents, comprising a cup-shaped mesh stent 1 is connected to the cup-shaped mesh stent in a sleeve 2 the goblet-shaped bracket 1 comprising a base web 41, and the cup body 43 for connecting the bottom of the cup, the cup holder cup body 42, with reference to FIGS. 3 and 4, the lifting edge to the cup base and the cup body is formed bent edge 45, the cup-shaped mesh stent 1 was left by the helix shape of the filament and a metal line as a right-handed screw shaped metal filament cross-weave configuration, generally, a metal filament using N1-Ti shape memory alloy wire, with reference to FIG. 2, the shank portion of the metal cup constituting filament lead of the helix is ​​greater than the spiral conductive metal filament constituting the bottom of the cup and the cup body portion, and a metal filament constituting the cup stem portion helix lead composition is 60 ~ 145mm, constituting part of the bottom of the cup helix lead metal filament is 55~100mm, spiral cup body constituting the lead portion of the metal filament is 40 ~ 85mm, a this mesh stent that goblet-shaped cup holder 42 having a capacity for elastic deformation, with reference to FIG. 4, the mesh covering the goblet-shaped bracket 1 高分子材料裙边3,所述裙边3从杯底延伸至杯身并与所述套管2连接。 3 polymer material skirt, said skirt extending from the cup bottom 3 to the cup body 2 and connected to the sleeve.

[0044]实施例2-十二指肠支架的制备方法一种十二指肠支架的制备方法,包括以下步骤:步骤1制备圆形金属网管步骤1.1在图6所示的组合编织模具上,将金属丝绕制成第一段螺旋线且所述第一段螺旋线的长度与酒杯形网状支架的杯底圆盘的径向尺寸相对应,加大导程并继续绕制第二段螺旋线,第二段螺旋线的长度与酒杯形网状支架的杯柄高度相对应,减小导程并继续绕制第三段螺旋线,第三段螺旋线的长度与酒杯形网状支架的杯身高度相对应,步骤1.2在步骤1.1所述第三段螺旋线的末端折弯金属丝,并将金属丝朝向起始端继续绕制第四段螺旋线,且所述第四段螺旋线的长度与酒杯形网状支架的杯身高度相对应, 所述第四段螺旋线与所述第三段螺旋线交叉形成杯身交叉点,构成任意相邻两个杯身交叉点中的一个杯身交叉点的第四段螺旋线从所述第三段螺旋 Preparation Example 2 - Preparation of a method of duodenal stents duodenal stent [0044] embodiment, comprising the steps of: a step of preparing a composition knitting circular metal mold NM 1.1 in the step shown in FIG. 6, the radial dimension of the first section of wire wound into a spiral and the length of the first segment of the spiral mesh stent goblet-shaped bottom of the cup corresponding to the disc, and continues to increase the lead wound second section helix, cup stem height and length of the second section of the helix-shaped glass mesh stent corresponding to reduce lead and a third segment continuing spiral wound, the length of the third segment helix-shaped glass Wallstent corresponding to the height of the cup body, the step of bending the wire at the end of 1.2 the third paragraph of the helix step 1.1, and continue to the starting end toward the wire wound helix fourth segment, and the fourth segment helix the length of the glass holder shaped mesh corresponding to the height of the cup body, a cup body with spiral fourth segment intersection lines crossing the third section spiral form, constituting a body of any adjacent two intersections in the cup fourth segment helix cup body from said third intersection point spiral 下方穿过,构成任意相邻两个杯身交叉点中的另一个杯身交叉点的第四段螺旋线从所述第三段螺旋线上方穿过压过; 加大导程并接着绕制第五段螺旋线,第五段螺旋线的长度与酒杯形网状支架的杯柄高度相对应,所述第五段螺旋线与所述第二段螺旋线交叉形成杯柄交叉点,构成任意相邻两个杯柄交叉点中的一个杯柄交叉点的第五段螺旋线从所述第二段螺旋线下方穿过,构成任意相邻两个杯柄交叉点中的另一个杯柄交叉点的第五段螺旋线从所述第二段螺旋线上方穿过压过;减小导程并接着绕制第六段螺旋线,第六段螺旋线的长度与酒杯形网状支架的杯底圆盘径向尺寸相对应,所述第六段螺旋线与所述第一段螺旋线交叉形成杯底交叉点,构成任意相邻两个杯底交叉点中的一个杯底交叉点的第六段螺旋线从所述第一段螺旋线下方穿过,构成任意相邻两 Through the bottom, the other cup body constituting any adjacent two intersections in the intersections of the cup body in the fourth paragraph spiral helix from said third party through forced through; and then lead to increase wound helix fifth paragraph, the fifth paragraph cup stem height and length of the helix-shaped glass mesh stent corresponding to the fifth paragraph of the cup handle helix intersection intersect the second section spiral form, constituting any a shank adjacent to the intersection of the two cup Cup-crossing points of the fifth paragraph of the second section helix from below through the spiral, constituting any adjacent two intersecting another cup holder cup holder crosspoint points from the fifth paragraph of the second section helix coil side through the pressure line therethrough; and then reducing the lead spiral wound, sixth paragraph, the length of the cup-shaped glass mesh stent sixth paragraph helix bottom disk radial dimension corresponding to the segments of the first section and the sixth spiral coil formed cup base lines crossing intersections, intersection of the first bottom of the cup bottom of the cup two intersections constitutes any adjacent sixth spiral helix from below through the first section, in which arbitrary two adjacent 杯底交叉点中的另一个杯底交叉点的第六段螺旋线从所述第一段螺旋线上方穿过压过; Another cup bottom of the cup base intersection, sixth paragraph spiral cross point from the first section through the pressure line side through the coil;

步骤1.3在步骤1.2所述第六段螺旋线的末端折弯金属丝,并重复步骤1.1和步骤1.2直至形成圆形金属网管; At the end of step 1.3, sixth paragraph 1.2 the helix step of bending a metal wire, and the step of repeating steps 1.1 and 1.2 until a circular metal mesh is formed;

需要说明的是,本发明在螺旋线绕制过程中,螺旋线经折弯后,将要绕制的螺旋线旋向与折弯前的螺旋线旋向相反,这样,由一根金属丝即可绕制成完整的圆形金属网管。 Incidentally, in the present invention is a spiral wound molding process, the spiral after bending, to be wound to a helix and spiral rotation of the pronation bent in the opposite, so that, to a piece of wire circular metal wound into a complete network management.

[0045] 步骤2对圆形金属网管进行定形处理 [0045] Step 2 circular metal mesh for setting treatment

将圆形金属网管套在酒杯形状的定形模具上,且确保金属网管服帖捆绑在定形模具上,具有酒杯形金属支架的形状和尺寸。 Circular metal mesh sleeve on the shaping die shape glass, metal mesh and ensures docile tied to the shaping die having a shape and dimensions goblet-shaped metal bracket. 然后,将它们一起置于420~510°C温度环境中保温20~50分钟。 Then, they were placed together with 420 ~ 510 ° C temperature environment incubated 20 to 50 minutes. 保温后水冷,卸下定形模具,就得到了酒杯形网状支架。 After incubation cooled, remove the shaping die, to obtain a glass-shaped mesh stent. 本实施例具体可以选择置于420°C温度环境中50分钟、450°C温度环境中40分钟或510°C温度环境中20分钟; Specific embodiments of the present embodiment may be placed in selected temperatures 420 ° C for 50 minutes, 450 ° C temperature environment for 40 minutes or 510 ° C temperatures for 20 min;

步骤3在酒杯形网状支架上连接套管,得到十二指肠支架;在酒杯形网状支架上连接套管方法可以有多种,本实施例可以具体采用以下两种方法之一: Step 3 connected to the goblet-shaped mesh stent sleeve, duodenal stents obtained; method can have multiple connecting sleeve on goblet-shaped mesh stent, the present embodiment may be one of two specific methods:

方法一:在酒杯形网状支架上连接套管的方法为:用胶黏剂将成形的套管粘接在酒杯形网状支架上。 Method a: Method of coupling sleeve on a goblet-shaped mesh stent as: adhesive bonding the sleeve to the shaping of the goblet-shaped mesh stent.

[0046] 方法二:在酒杯形网状支架上连接套管的方法为:参见图8,将酒杯形网状支架(I)套在圆管形模具5上,再将套有酒杯形网状支架的圆管形模具浸入高分子材料乳液中,将套有酒杯形网状支架的圆管形模具提拉出高分子材料乳液,在酒杯形网状支架和圆管形模具上形成一层高分子材料的薄膜,经160~220°C、30~60分钟的硫化处理后,在酒杯形网状支架I上和圆管形模具5上形成共为一体的高分子材料薄膜,并且在酒杯形网状支架杯底弯折边上形成裙边3,最后卸除圆管形模具,圆管形模具的材质通常选用玻璃。 [0046] Method II: Method of coupling sleeve on goblet-shaped mesh stent as: Referring to Figure 8, the goblet-shaped mesh stent (I) in the sleeve-shaped mold tube 5, and then sheathed with glass-shaped mesh tube-shaped die holder is immersed in an emulsion polymer material, the sleeve has a round tubular mesh stent goblet-shaped mold for pulling out the emulsion polymer material, is formed on the layer of high goblet-shaped and tube-shaped die wallstent film material molecules, by 160 ~ 220 ° C, vulcanized for 30 to 60 minutes, in the goblet-shaped mesh stent co-polymer material film I is formed integrally on the tube-shaped mold and 5, and goblet-shaped mesh stent is bent cup bottom edge of the skirt 3 is formed, and finally unloading tube-shaped die, the material is usually used glass tube shaped mold.

[0047]实施例3-用于绕制圆形金属网管的模具 [0047] Example 3 wound round a mold for the metal mesh

一种用于十二指肠支架制备方法的模具,包括:螺栓65,在螺栓65上依次套设有编织杯底圆筒形模具61、编织杯柄圆筒形模具62和编织杯身圆筒形模具63,且由设在螺栓65两端的螺帽66固紧,在编织杯底圆筒形模具61、编织杯柄圆筒形模具62和编织杯身圆筒形模具63,上设有螺旋形凹槽,所述螺旋形凹槽始于编织杯底圆筒形模具61的外端,延伸至编织杯身圆筒形模具63的外端,折返并转换成反向螺旋形凹槽,延伸至编织杯底圆筒形模具61的外端,以此反复延伸直至形成螺旋形凹槽网,并且位于编织杯柄圆筒形模具62上的螺旋形凹槽的螺旋线导程大于编织杯底圆筒形模具61和编织杯身圆筒形模具63的导程,所述编织杯底圆筒形模具61的长度与酒杯形网状支架的杯底圆盘径向尺寸相对应,编织杯柄圆筒形模具62的长度与酒杯形网状支架的杯柄高度相对应,编织杯身圆 A mold for preparing a duodenal stents, comprising: a bolt 65, the bolt 65 is provided with sequentially braided sleeve cylindrical mold cup base 61, the cup handle braided cylindrical mold 62 and the braided cylindrical cup body shaped die 63, and a bolt 65 provided at both ends of the fastening nut 66, the cylindrical mold cup base 61 woven, knitted cup stem 62 cylindrical mold and the braided cylindrical mold the cup body 63, a spiral on shaped groove, the spiral groove starts braided outer cup bottom end of the cylindrical mold 61, extending to the outer end of the braided cylindrical mold cup body 63, and converted into reverse folded spiral groove extending to the outer end of the braided cylindrical mold cup base 61, thus repeated until a helical groove extending mesh, and spiral groove located on the stem cup-woven cylindrical mold 62 is greater than the lead of the spiral braided cup base cylindrical mold 61 and the braided cylindrical mold the cup body of the lead 63, the braid cup base cylindrical mold with a length of mesh 61 goblet-shaped bottom of the cup holder corresponding to the radial dimension of the disc, woven cup stem Cup shank height and length of the cylindrical mold goblet-shaped bracket 62 mesh corresponds to a circular knitting mug 筒形模具63的长度与酒杯形网状支架的杯身高度相对应。 Barrel die 63 of the cup body height goblet-shaped mesh stent length corresponds.

[0048] 实施例4-支架置入器械 [0048] Example 4 embodiment stent device

本发明所述支架置入器械是用于输送十二指肠支架的置入器械,本发明所述支架置入器械可以采用一根捆绑线分别捆绑十二指肠支架远端和近端,此时,置入器械的芯管采用双腔管,即一个主腔84和一个副腔即一个捆绑线通道,例如第一捆绑线通道851。 The present invention is a stent delivery instrument into the instrument duodenal stents, the stent of the present invention may employ an instrument bundled lines are bundled distal and proximal duodenal stents, this , the core tube into the instrument using the double lumen, i.e., a main chamber and a secondary chamber 84 that is a binding wire channel, for example a first binding wire channel 851. 以下以一根捆绑线通过一个捆绑线通道对十二指肠支架进行两端捆绑为例加以具体说明: The following lines of binding to a bracket by a binding wire duodenal end of the tunnel to be tied specifically described as an example:

实施例4.1 Example 4.1

一种十二指肠支架的支架置入器械,参见图12,包括:芯管8且芯管8用于承载所述十二指肠支架,在芯管8的管壁上设有第一捆绑线通道851和第一支架捆绑线窗口82,在第一捆绑线通道851内设有用于固定捆扎所述十二指肠支架的第一捆绑线87,在芯管8的芯管壁上设有径向排液孔88,且所述径向排液孔88与芯管的主腔84连通。 A stent is placed into the instrument duodenal stents, see Figure 12, comprising: a core tube and core tube 8 for carrying the duodenal holder 8 is provided in the wall of the first core tube bundle 8 a first bracket 851 and a wire channel bundling window line 82, the first wire channel 851 binding site for fixing a first bundle of duodenal stents line bundle 87, is provided on the core of the wall of core tube 8 radial drain holes 88, and the radial discharge hole 88 of the core tube 84 communicating the main chamber. [〇〇49] 在本实施例中,在芯管8的第一捆绑线通道851上开设另一个支架捆绑线窗口83, 则可以利用第一捆绑线87在第一支架捆绑线窗口82处进行十二指肠支架远端捆绑后,再在所述第二支架捆绑线窗口83处进行十二指肠支架的近端捆绑。 [〇〇49] In this embodiment, defines a further line holder bundling window on the first wire channel 851 of the core tube bundle 8 is 83, the line 87 may be utilized for a first bundle at a first line bundling window holder 82 after the distal end of the duodenum tied stent, then the stent proximal end of the duodenum tied in the second line bundling window holder 83.

[0050] 实施例4.2一种十二指肠支架的支架置入器械,参见图9,包括:芯管8且芯管8用于承载所述十二指肠支架,在芯管8的芯管壁上设有第一捆绑线通道851和第一支架捆绑线窗口82,在第一捆绑线通道851内设有用于固定捆扎所述十二指肠支架的第一捆绑线87,在芯管8的芯管壁上设有径向排液孔88,且所述径向排液孔88与芯管的主腔连通,所述第一支架捆绑线窗口82位于所述芯管8的远端,在芯管8的芯管壁上还设有第二捆绑线通道852和第二支架捆绑线窗口83,且所述第二支架捆绑线窗口83,相对于第一支架捆绑线窗口82位于其近端側,在第二捆绑线通道852内设有用于固定捆扎所述十二指肠支架的第二捆绑线86。 [0050] Example 4.2 stent is placed into the instrument one kind duodenal stents, see Figure 9, comprising: a core tube and core tube 8 for carrying the duodenal stents 8, the core tube of the core tube 8 a first passage wall 851 and the first wire bundle bundling bracket 82 line window, the first site binding wire channel 851 for fixing a first bundle of duodenal stents line bundle 87, the core tube 8 the wall of the core is provided with a radial discharge hole 88, and the radial discharge ports main chamber 88 communicates with the core tube, said first bracket bundling window line 82 at the distal end of the core tube 8, on the core wall core tube bundle 8 is also provided with a second wire channel 852 and the second support wire bundling window 83, and the second line bundling window holder 83 with respect to the first wire holder bundling window 82 located near end side of the second wire channel 852 binding site for the binding of the second binding wire fixing bracket 86 duodenum. [0〇51] 在芯管8的远端头部设有软头81,在芯管8的近端尾部连接有手柄9,所述手柄9包括主管93、第一尾管94和第二尾管95,手柄主管93与芯管8的芯管的主腔84及副腔851、852 相通,第一尾管94与第一捆绑线通道851连接,且所述第一捆绑线87穿过第一尾管94,第二尾管95与第二捆绑线通道852连接,且所述第二捆绑线86穿过第二尾管95,在第一尾管94和第二尾管95的末端分别设有鲁尔接头91,在鲁尔接头91设有密封盖92。 [0〇51] is provided at the distal end of the head 8 of the soft head core tube 81 is connected to a handle 9 at the proximal end of the tail core tube 8, the handle 93 includes a main pipe 9, a first and a second end of the tail pipe 94 pipe 95, the main chamber and the auxiliary chamber 84 of the handle 93 in charge of the core die 851, 852 of the communication tube 8, a first end of the first tube bundle 94 is connected to the line passage 851, and the wire bundle 87 that passes through the first a tube 94, a second tail pipe 95 is connected to the second binding line passage 852, and the second wire bundle 86 passes through the second tail pipe 95, respectively, at the end of the first tube 94 and the second end of tailpipe 95 luer fitting 91 is provided, the sealing cap 92 is provided with luer connector 91. [〇〇52] 实施例5一种将十二指肠支架固定在支架置入器械上的捆绑方法,将十二指肠支架套在已设置了捆绑线的支架置入器械上,再用十二指肠支架捆绑方法将十二指肠支架捆绑于支架置入器械上,所述的十二指肠支架捆绑方法包括以下步骤:步骤A:将捆绑线绕成一次绳圈71且捆绑线的远端被压在捆绑线的下方,再将捆绑线在十二指肠支架的外部环绕,然后将捆绑线的近端穿过所述绳圈后再绕一个环即二次绳圈72 并将捆绑线的近端再次穿过所述一次绳圈71,同时将所述二次绳圈72当作次新绳圈,步骤B:将捆绑线在十二指肠支架外部再进行环绕,然后将捆绑线的近端穿过所述次新绳圈后再绕一个新环并将捆绑线的近端再次穿过所述次新绳圈,步骤C:将步骤B得到的新绳圈当作次新绳圈,返回步骤B,在形成一串环后进入步骤D, 步骤D:用压线圈7将最后一个新 [〇〇52] Example 5 A method of binding duodenal stenting bracket on the device, the sleeve has been set duodenal stents stent wire bundle placed on the instrument, and then ten the method of bundling the duodenum duodenal stents holder tied to the stent device, duodenal stents bundling said method comprising the following steps: step a: a wound bundled into a bundled wire ropes 71 and below the bundle is pressed against the distal end of the wire, and then around the wire bundle on the outside duodenal stents, and then passes through the proximal end of the wire bundle and then loops around a loop i.e. the secondary loops 72 and the proximal end of the wire bundle once again through the ropes 71, while the secondary loops 72 times as new loops, step B: a bundle around the outside line then duodenal stents, then the binder thread passes through the proximal end of the ropes after the second new loop around a proximal end of the new line through the bundle and the second new ropes again, step C: step B as a new sub-loops new ropes return to step B, and proceeds to step D after formation of the string loop, step D: compression coil 7 with the last new 圈压住,再将捆绑线穿过捆绑线通道并从支架置入器械的尾部穿出。 Ring pressed, then the binding thread through the passage and from the cable bundle stent tail piercing instrument. [〇〇53] 在本实施例中,为了缩短十二指肠支架在置入器械上的捆绑长度,在十二指肠支架捆绑前,对十二指肠支架的套管进行轴向套叠或轴向折叠,轴向套叠或轴向折叠的方式如图16和17所示。 [〇〇53] In the present embodiment, in order to shorten the length of the bundle in the duodenum stent placement instrument, duodenal stents before bundling, duodenal cannula for axially nested stent or axially folded, collapsed or axially axially nested manner shown in Figures 16 and 17. 置入器的芯管可采用双腔或三腔管,分别用单线或双线对十二指肠支架进行捆绑,此即为单线或双线轴向套叠捆绑输送方式和单线或双线轴向折叠捆绑输送方式,这类捆绑方式,仍然分别捆绑十二指肠支架的远端和近端,但近端捆绑线圈的范围要覆盖除已被捆绑的远端以外的支架其余部分。 Core tube inserter may employ dual lumen or triple lumen, respectively, are bundled with a single or double duodenal stents, that is, for a single or double telescopic axial bundle transport mode or dual-line spool and folding the bundle transport mode, such wrapping method, were still bundled distal and proximal duodenum stent, but the scope of the proximal end of the coil bundle to cover the remainder of the stent other than the distal end has been tied. [〇〇54] 本发明所述捆绑方法是出于方便置入具有长而软的套管的十二指肠支架的目的, 这种捆绑方法在将十二指肠支架捆绑在支架置入器械上并置入到位后,通过抽拉留在支架置入器械尾部的捆绑线,即可实现捆绑线的拆卸,十二指肠支架随即脱离支架置入器械。 [〇〇54] The present invention is a method for bundling purposes of convenience with duodenal stents into long, flexible sleeve, in the method of this bundle bundled duodenal stents stent device after into place and by pulling the tail of the instrument to stay in the stent wire bundle, bundle disassembly line can be realized, then departing duodenal stents stent device.

[0055] 下面对本发明的实时方式作出更为详细的描述:十二指肠支架的金属支架部分用含54.5〜57.0 wt %Ni的¢0.16 mm NiTi形状记忆合金丝材编织,套管高分子材料选用医用聚氨酯。 [0055] The following more detailed description of making the real-time embodiment of the present invention: a metal carrier portion with a duodenal stents containing 54.5~57.0 wt% Ni ¢ of 0.16 mm NiTi shape memory alloy wire braided sleeve polymer material selection of medical polyurethane. 整个支架的长度为450mm。 The entire stent length is 450mm. 其中金属支架的长度L=48,金属支架的杯身长度Ll=20,杯柄长度L2= 10,杯底长度L3=7,杯身、杯柄及杯底三部分的直径分别是1=25,巾2=15和巾3=35。 Wherein the length of the metal stent L = 48, the metal cup holder body length Ll = 20, cup stem length L2 = 10, the cup base length L3 = 7, the diameter of the three-part cup body, the cup bottom of the cup and the stem 25 are respectively 1 = , towel and napkin 2 = 15 3 = 35. 选用直径为巾20的三段组合模具作为编织模具,各段上左右旋螺旋线的头数相同,均为18,而导程各不相同,三部分的导程分别为68、 116和36mm,分别与杯底、杯柄和杯身相对应。 Selection of a combination of three sections towel diameter die mold 20 as woven around the same number of segments of the spiral screw heads, both 18, and the lead are different, the three-part lead 68, respectively, and 116 is 36mm, respectively and bottom of the cup, cup handle and cup body, respectively. 编织好网管毛坯捆扎在定形模具上,定形模具将网管毛坯撑开,确保金属支架形状和尺寸达到设计的轮廓形状和尺寸。 Good network bundled braided on blank shaping mold, the shaping die blank network distraction, the contour shape and size to ensure that the metal bracket shape and size to meet the design. 将定形模具连同捆扎好的金属网管支架毛坯一起放入炉温为500 ± 5°C的箱式电炉中,并在炉中保温30 ± 2 分钟。 The shaping die along with good metal mesh stent blank bundled together into a furnace temperature of 500 ± 5 ° C in a box furnace, and incubated in an oven at 30 ± 2 minutes. 保温后,将定形模具连同金属支架一起在水中冷却,冷却后将金属支架从定形模具上取下,只要环境温度高于25°C,定形后的金属支架就具有最初设计时的形状和尺寸,且在受外力发生变形后只要去除外力后,能立刻恢复定形后金属支架具有的最初设计的形状和尺寸。 After incubation, the shaping mold together with the metal holder with cooling water, after cooling the metal bracket removed from the shaping die, as long as the ambient temperature is above 25 ° C, the amorphous metal stent having a shape and size to the original design, and and the shape and size after deformation by external force as long as the external force is removed, can be restored immediately shaped metal bracket having originally designed.

[0056] 套管制作材料选用用医用聚氨酯材料,预先将医用聚氨酯配成聚氨酯乳液备用。 [0056] Selection cannula with medical materials made of polyurethane material, previously formulated polyurethane emulsion alternate medical polyurethane. [〇〇57] 再将定形后酒杯形的金属网状支架套在玻璃管状模具上,玻璃管状模具也要确保套在其上的金属支架仍然具有最初设计的形状和尺寸。 [〇〇57] is then shaped glass shaped metal mesh stent fitted over the tubular glass mold, the mold must also ensure that the tubular glass sleeve on which the metal support having a shape and dimensions still originally designed. 将玻璃模具连同其上的金属支架一同浸入聚氨酯乳液中,然后将玻璃模具连同金属支架由乳液中提拉出来,金属支架部分在上,将玻璃模具竖直放置,多余的乳液往下流淌,玻璃模具上聚氨酯乳液的包覆范围,其长度要超过套管的设计长度450mm。 The glass mold together with a metal holder which is immersed in the polyurethane emulsion, and then the glass mold together with the metal holder pulled out from an emulsion, the metal stent portion on the glass mold vertically, excess emulsion flowing down, glass polyurethane emulsion coated range on the mold, designed to exceed the length of the sleeve length 450mm. 然后,将包覆有聚氨酯乳液的玻璃模具(其上有酒杯形金属网状支架)放进烘箱中进行硫化处理,硫化处理的温度为180 ± 15 °C,时间为60 ± 15分钟。 Then, the glass mold coated with polyurethane emulsion (on which the glass-shaped metal mesh stent) placed in an oven for curing treatment, the temperature of the vulcanization treatment is 180 ± 15 ° C, the time was 60 ± 15 minutes. 硫化处理冷却后,将支架连同套管从玻璃模具上取下,按设计的套管长度修剪,确保整个支架的长度为500 ± 2mm。 After cooling the vulcanization process, the stent is removed from the glass mold together with the sleeve, by trimming the length of the sleeve design, to ensure that the entire stent length is 500 ± 2mm.

[0058] 支架输送方式,采用简单输送方式。 [0058] The stent delivery embodiment, a simple transport mode. [〇〇59] 支架的金属支架部分用含54.5〜57.0 wt %Ni的¢0.15 mm NiTi形状记忆合金丝材编织,套管高分子材料选用医用硅橡胶。 [〇〇59] metallic stent containing part of the stent of 54.5~57.0 wt% Ni ¢ 0.15 mm shape memory alloy wire braided NiTi, sleeve polymer material selected medical silicone rubber. 整个十二指肠支架的长度为350mm。 Duodenal stents entire length of 350mm. 其中金属支架的长度L=46,金属支架的杯身长度Ll=20,杯柄长度L2= 12,杯底长度L3=6,杯身、杯柄及杯底三部分的直径分别是巾1=24,巾2=14和巾3=34。 Wherein the length of the metal stent L = 46, the metal cup holder body length Ll = 20, cup stem length L2 = 12, the cup base length L3 = 6, the diameter of the three-part cup body, the cup bottom of the cup and the stem are towel 1 = 24, towel and napkin 2 = 14 3 = 34. 选用直径为巾20的三段组合模具作为编织模具,各段上左右旋螺旋线的头数相同,均为18,而导程各不相同,三部分的导程分别为66、114和34,分别与杯底、杯柄和杯身相对应。 Selection of a combination of three sections towel diameter die mold 20 as woven around the same number of segments of the spiral screw heads, both 18, and the lead are different, the three-part lead 34 and 66,114, respectively, respectively and bottom of the cup, cup handle and cup body, respectively. 编织好网管毛坯捆扎在定形模具上,定形模具将网管毛坯撑开,确保金属支架形状和尺寸达到设计的轮廓形状和尺寸。 Good network bundled braided on blank shaping mold, the shaping die blank network distraction, the contour shape and size to ensure that the metal bracket shape and size to meet the design. 将定形模具连同捆扎好的金属网管支架毛坯一起放入炉温为500 ± 5°C的箱式电炉中,并在炉中保温30 ±2分钟。 The shaping die along with good metal mesh stent blank bundled together into a furnace temperature of 500 ± 5 ° C in a box furnace, and incubated in an oven at 30 ± 2 minutes. 保温后,将定形模具连同金属支架一起在水中冷却,冷却后将金属支架从定形模具上取下,只要环境温度高于25°C,定形后的金属支架就具有最初设计时的形状和尺寸,且在受外力发生变形后只要去除外力后,能立刻恢复定形后金属支架具有的最初设计的形状和尺寸。 After incubation, the shaping mold together with the metal holder with cooling water, after cooling the metal bracket removed from the shaping die, as long as the ambient temperature is above 25 ° C, the amorphous metal stent having a shape and size to the original design, and and the shape and size after deformation by external force as long as the external force is removed, can be restored immediately shaped metal bracket having originally designed.

[0060] 十二指肠套管制作材料选用用医用硅橡胶材料,预先将医用硅橡胶配成乳液备用。 [0060] Selection duodenal cannula with medical materials made of silicone rubber material previously medical silicone rubber latex formulated standby.

[0061] 再将定形后的酒杯形金属网状支架套在玻璃管状模具上,玻璃管状模具也要确保套在其上的金属支架仍然具有最初设计的形状和尺寸。 [0061] and then the amorphous metal mesh stent sheath goblet-shaped glass tube on the mold, the mold must also ensure that the tubular glass sleeve on which the metal support having a shape and dimensions still originally designed. 将玻璃模具连同其上的金属支架一同浸入娃橡胶乳液中,然后将玻璃模具连同金属支架由乳液中提拉出来,金属支架部分在上,将玻璃模具竖直放置,多余的乳液往下流淌,玻璃模具上硅橡胶乳液的包覆范围,其长度要超过套管的设计长度350_。 The glass mold together with the metal holder on which the baby is immersed in the emulsion rubber, the glass mold was then pulled together by the metal bracket out of the emulsion, the metal portions on the holder, the glass mold vertically, excess emulsion flowing down, silicone rubber latex coated range on a glass mold, to a length which exceeds the length of the sleeve design 350_. 然后,将包覆有硅橡胶乳液的玻璃模具(其上有金属支架)放进烘箱中进行硫化处理,硫化处理的温度为180 ± 15°C,时间为60 土15分钟。 Then, the glass coated with silicon rubber mold emulsion (on a metal stent) placed in an oven for curing treatment, the temperature of the vulcanization treatment is 180 ± 15 ° C, time of 60 ± 15 minutes. 硫化处理冷却后,将支架连同套管从玻璃模具上取下,按设计的套管长度修剪,确保整个支架的长度为396±2mm。 After cooling the vulcanization process, the stent is removed from the glass mold together with the sleeve, by trimming the length of the sleeve design, to ensure that the entire stent length is 396 ± 2mm. 支架输送方式采用双线轴向套叠捆绑输送方式或轴向折叠捆绑输送方式。 The stent delivery embodiment two wire bundles axially telescopic manner or axially folded bundle conveying transport mode.

Claims (3)

1.一种将十二指肠支架固定于支架置入器械的捆绑方法,其特征在于,将十二指肠支架套在已设置了捆绑线的支架置入器械上,再用十二指肠支架捆绑方法将十二指肠支架捆绑于支架置入器械上,所述的十二指肠支架捆绑方法包括以下步骤:步骤A:将捆绑线绕成圈(71)且捆绑线的远端被压在捆绑线的下方,再将捆绑线在十二指肠支架的外部环绕,然后将捆绑线的近端穿过所述圈后再绕一个环(72)并将捆绑线的近端再次穿过所述圈(71),同时将所述环(72)当作次新环,步骤B:将捆绑线在十二指肠支架的外部再进行环绕,然后将捆绑线的近端穿过所述次新环后再绕一个新环并将捆绑线的近端再次穿过所述次新环,步骤C:将步骤B得到的新环当作次新环,返回步骤B,在形成一串环后进入步骤D,步骤D:用压条(7)将最后一个新环压住,再将捆绑线穿过捆绑线通道并从支 1. A holder fixed to the duodenal stent instrument binding method, wherein the sleeve has been set duodenal stents stent wire bundle placed on the instrument, and then the duodenum methods duodenal stents stent bundle tied to the stent device, duodenal stents bundling said method comprising the following steps: step a: a wound bundle looped distal end (71) and the wire is bundled binding under the pressure line, and then tied around the wire holder on the outside of the duodenum, and then the proximal end of the wire bundle after passing through the ring about a ring (72) and the proximal end of the wire bundle through again through the ring (71), while the ring (72) as the second new ring, step B: a bundle around the outside line then duodenal stents, and then passes through the proximal end of the wire bundle said second new ring after ring around a proximal end of the new line and bind again passes through the secondary of the new ring, step C: step B as a second new ring new ring returns to step B, is formed in the string after entering the ring Procedure D, step D: with a bead (7) presses the last of the new ring, then the binding thread through the passage and the branch wire bundle 置入器械的尾部穿出。 Piercing instrument into the tail.
2.根据权利要求1所述的将十二指肠支架固定于支架置入器械的捆绑方法,其特征在于,用十二指肠支架捆绑方法将十二指肠支架的远端和近端都捆绑于支架置入器械上,远端拥绑1〜5圈,近端将金属网状支架部分完全拥绑住。 The bracket is fixed to the duodenum in a method of stenting binding instrument, characterized in that the binding method duodenal duodenal stent distal and proximal ends of the stent are claimed in claim tied to the stent device, the distal end of hold ring tied ~ 5, the proximal end portion of the metal mesh stent owned completely tied.
3.根据权利要求1或2所述的捆绑方法,其特征在于,在捆绑十二指肠支架前,对十二指肠支架的套管进行轴向套叠或轴向折叠。 The binding method of claim 1 or claim 2, characterized in that, before binding duodenal stents, duodenal stents of the casing axially or axially nested collapsed.
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