CN101511306A - 带有近端和远端附连递送导管的包覆支架及其制备方法 - Google Patents
带有近端和远端附连递送导管的包覆支架及其制备方法 Download PDFInfo
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
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- A—HUMAN NECESSITIES
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- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/02—Inorganic materials
- A61L31/022—Metals or alloys
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
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- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
- Y10T29/49947—Assembling or joining by applying separate fastener
Abstract
金属或伪金属包覆的支架,其中,所述支架元件和包覆元件各自由生物相容金属或伪金属材料构成,包覆元件和支架通过在其各近端和远端的至少一个接合件连接。还提供了连接支架和包覆元件的方法。
Description
发明背景
本发明一般涉及植入式医疗器件,更具体地涉及能采用微创递送技术植入的植入式医疗器件。更具体地,本发明涉及可采用微创递送技术植入解剖学通道的包覆的支架、支架-移植物和支架-移植物型器件。更具体地说,本发明包括完全由生物相容性金属或具有与生物相容性金属基本上相同的生物反应和材料特征的生物相容性材料(例如复合材料(后文中称为“伪金属(pseudometal)”或具有“伪金属的”性质))构成的包覆的支架、支架-移植物和支架-移植物型器件。更具体地说,本发明涉及金属支架和金属支架包覆物,其中,所述金属支架包覆物通过在其近端和远端各自与金属支架间的至少一个接合件(juncture)附连。
支架典型地是网格结构,该结构能采取径向压缩构型和径向扩张构型,径向压缩构型时便于递送至安放位置,而在径向扩张构型时,支架向外扩张并抵靠解剖学通道的内壁从而为脉管提供结构支撑,恢复和维持脉管开放。例如,血管成形术后常常使用管腔内支架来提供血管结构支撑并降低经皮气囊血管成形术后再狭窄的发生率。例如,可采用引导导管,穿过在远端引导位置与疾病或创伤部位间连通的脉管系统,将血管内支架从远离疾病或创伤部位的引导位置引入身体脉管系统内的疾病或创伤部位,并在疾病或创伤部位的血管内将该支架从引导导管释放,以在疾病或创伤部位维持血管开放。
在许多应用中,希望提供带有能赋予支架其本身不具有的特殊所需性质的包覆层的支架。例如,裸支架与显著的再狭窄发生率有关,因为通常需要在支架壁上形成大的开孔以适应支架从压缩状态径向扩张至扩张状态,允许颗粒物质(如碎片斑块)通过血管壁进入血流。较大的开孔允许颗粒物质(例如易碎斑块或栓物质)驻留在血管壁上,穿过开孔进入体循环。然而,通过在支架的管腔面或近腔面(ablumenal)或这两个面上提供包覆层可减少上述不良作用,从而形成包覆的支架或者(为了应用的目的)等同于支架-移植物。
发明概述
根据本发明,提供了一种包覆的支架,在该支架与覆盖元件之间具有近端和远端固定点。
此外,提供了使包覆物与支架附连的方法,该方法包括:将支架装载到约束套管(restraining sheath)内,该约束套管内同心(concentrrically)啮合有推杆组件;将支架装载到约束套管内一定深度,以使支架近端保持从约束管的末端伸出;使包覆物同心啮合在约束套管的外周并对齐,以使包覆物的近端与支架近端同心对齐;在支架近端与包覆物近端之间形成近端固定;然后使约束套管与限制管的远端同轴对齐定位,启动推杆组件以将支架和近端固定的包覆物推入限制管的远端,直到暴露出支架的远端和包覆物的远端的位置;在支架远端与包覆物远端之间形成远端固定,钝化现已近端和远端固定的支架和包覆物,然后与限制管的远端同轴对齐定位,启动推杆组件以将支架和近端固定的包覆物推入递送导管管腔远端;然后将推杆组件从导管近端装载到递送导管内,并使导线和防损伤尖端以倒退方式从递送导管的远端装载。
结合附图,上述内容以及以下本发明优选实施方式的详细描述将会得到更好地理解。为了阐述本发明,附图中显示了本发明优选的实施方式。但是应理解,本发明并不限于所示精确排列与手段。
附图简要说明
图1A-1D为连续的截面侧视图,描绘了用于制备近端连接的包覆的支架组件的本发明设备和方法的装载组件。
图2A-2B为连续的截面侧视图,描绘了用于制备近端和远端连接的包覆的支架组件的本发明设备和方法的转移组件。
图3A-3C为连续的截面侧视图,描绘了将本发明近端和远端连接的包覆的支架组件装载到递送导管内。
图4A-4B为连续的截面侧视图,描绘了根据本发明另一优选的实施方式,将近端和远端连接的包覆的支架组件装载到渐细的(tapered)导管套管内。
图5A-5B为连续的截面侧视图,描绘了根据本发明另一优选实施方式的导管组件。
发明详述
现在参考附图,图1A-1D描绘了采用装载/焊接夹具40制备近端连接包覆的支架的过程。图1A描绘了将支架10装载到装载/焊接夹具40的装载套管30内。装载/焊接夹具40大致包括圆柱形装载套管30和推杆32,推杆32的一端联接有邻接元件34。邻接元件34同心啮合在装载套管30的管腔内,能够在护套30内往复运动。邻接元件34和推杆32具备双功能:第一,邻接元件34在支架10插入装载套管30管腔内期间用作止动件,以使支架在护套内适当定位;第二,推杆32和邻接元件34用于使近端固定支架和包覆物从装载套管30的管腔内排出。
图1B描绘了将包覆物20装载到装载套管30的近腔面上。如图1B所示,邻接元件34在装载套管30的管腔内距离d2处定位,使得装载套管30管腔的开放部分长d1。长度d1也等于使包覆物20固定于支架10所需的支架10从装载套管30近端区域31突出或暴露的程度。包覆物20在装载套管30的近腔面上同心定位,包覆物20的近端与支架10的近端对齐,使得装载套管30在支架10和包覆物20中间定位,且支架10的暴露近端11和包覆物20的近端21在其间相邻。这样,如图1C的圆圈部分所示,在包覆物20已装载在装载套管30上后,支架10的近端区域11和包覆物20的近端区域21可相连但不受到装载套管30的近端区域31的干扰。图1D描绘了图1C中圆圈部分的放大视图,用实线框(solid box)15来表示支架10近端区域11与包覆物20近端区域21之间的连接件的一个例子。因此,图1D描绘了近端连接的包覆的支架组件,它包括容纳在包覆物20内的支架10以及支架10和包覆物20近端区域间的连接点15。
图2A-2B描绘了将近端连接的支架10和包覆物20装载到限制管50上以及后续在支架10与包覆物20之间形成远端接合件16。图2A描绘了如图1制备的近端连接的包覆的支架组件,该组件已通过推杆32的轴向移动和装载套管30内的邻接元件34从装载套管30中推出。通过将限制管50设置成与装载套管30同轴对齐,当近端连接的包覆的支架组件从装载套管30中推出时,它将被推送入限制管50中。近端连接的包覆的支架组件位于限制管50内,使得组件延伸且从限制管50的远端伸出距离d3。组件的暴露远端允许在支架10和包覆物20之间形成远端接合件16。
图3A-3C描绘了组件的制备,所述组件包括导管套管60、近端和远端连接的包覆支架25、推杆元件80、导线轴(guidewire shaft)70和防损伤尖端90。在图3A中,近端和远端连接的包覆的支架组件部分地容纳在导管套管60内。图3A的近端和远端连接的包覆的支架组件25可如图1和2所示获得。在图3B中,图3A的近端和远端连接的包覆的支架组件已完全推入导管套管60内,而在图3C中,图3B的组件25,导线轴70同轴插入穿过包覆的支架组件25的中央腔室并延伸超出推杆元件80和导管套管60的末端(近端)。导线轴70插入之前,将防损伤尖端90固定于导线轴70的远端。防损伤尖端90回缩到与导管套管60远端成毗邻关系,从而将包覆的支架组件25包封在导管套管60内。
根据实施本发明的最佳模式,位于装载套管30内时,包覆物20优选处于马氏体状态,室温下无应变。然而,支架10优选为奥氏体,应在冷却介质(例如液氮浴、干冰和醇浴、冷却气体流等)的存在下装载到装载套管30内。压缩直径下的支架发生应变,因此,为了进行其它操作步骤,需要在限制管50或导管内。然而,装载到装载套管30和限制管50内之后,支架突出的近端或远端暴露于室温时将稍许张开。然而,这种稍许张开确保支架10和包覆物20间的适当定位并且有利于在支架10和包覆物20之间形成接合件,例如通过电阻点焊。
图4A-4B显示了将本发明包覆的支架组件25装载到导管套管100内,该导管套管用于约束装置的膨胀。图4B描绘了图1A-D制备的近端和远端连接的包覆的支架组件大致插入限制管50内。
图5A-5B描绘了在推杆元件110预先啮合在导管套管100内之后,完成导管组件120递送的步骤,因为在包覆的支架组件25已位于导管套管100内之后组装推杆元件110是不可行的。然后,如图5A所示,通过例如使用类似于图1A所示推杆元件34、32的推杆元件,可将包覆的支架组件25完全插入导管套管100内,使其毗邻或直接接触推杆元件110。一旦包覆的支架组件25完全插入导管套管100内且位置毗邻或直接邻接推杆元件,导线轴122可同轴插入通过包覆的支架组件25的中央腔室并延伸超出推杆元件110和导管套管100的末端。导线轴122插入之前,将防损伤尖端130固定于导线轴122的远端。防损伤尖端130回缩到与导管套管100远端成毗邻关系,从而将包覆的支架组件25包封在导管套管100内。
根据本发明的所有方面,如果支架10和包覆物20都由金属或伪金属材料构成(优选形状记忆或超弹性材料,最优选镍-钛合金),则希望通过热方法(例如激光焊接、等离子焊接、电阻焊接、电子束焊接)来形成连接点15或16。然而,如果支架10和包覆物20是异种材料,例如镍-钛合金和不锈钢,通过焊接来连接镍-钛合金和其它材料(如不锈钢)通常不可行,因为在焊接区域形成易碎的金属互化物。因此,当需要将镍-钛合金与其它生物相容性材料连接时,希望采用软焊、环氧化物或粘合剂来形成连接点15。或者,如果需要将异种材料焊接于镍-钛合金,已知可在焊接期间提供夹层材料(例如钽)以使易碎金属互化物的形成最小化。
最后,根据本发明的最佳模式及其优选实施方式,如图6A和6B所示,优选构建支架10,使其近端和远端接合点150可提供相对较大的大致平面区域,以在包覆物20和支架10间形成连接。接合点150可沿支架10的管腔面或近腔面的X-Y轴大致成四边形,优选具有与支架10其余部分相同的Z-轴壁厚度,并具有基本上对应于管状支架10曲率的微小曲率。图7是显示支架10焊接于包覆物20的接合点150的显微照片。
或者,如题为“具有中央支柱互连元件的管腔内支架”(Endoluminal stenthaving mid-strut interconnecting members)的共同待批、共同转让的美国专利申请出版号US20040186554A1;或题为“可植入的移植物及其制备方法”(Implantable graft and methods of making same)的共同待批、共同转让的美国专利申请出版号US20040098094A1中更详细所述,接合点150可为从末端近端和/或远端圆柱体元件的凸起而形成管状支架10(例如,参见‘554专利申请图1中的元件11或‘094专利申请图27中的元件307和304a-e,所述专利申请各自以参考的方式明确包括在此。
优选地,根据本发明的优选实施方式,如果支架和包覆物都采用形状记忆材料时,支架和包覆物具有不同的转变温度,支架的转变温度低于体温并在接触体温时径向膨胀,而包覆物优选具有高于体温的转变温度,植入体内后由于支架的膨胀而导致其去孪生(detwinned)马氏体塑性变形。因此,优选支架的Af≤29℃±3℃,而包覆物的Af约为60-100℃。这样,包覆物在制造、递送和植入体内后的期间可能遇到的所有情况下保持马氏体(状态)。另一方面,具有低于体温的Af的支架会被约束在递送导管中,在植入体内时易于扩张,并且随着支架的径向扩张容易扩张马氏体包覆物。
提供下面的实施例以阐述本发明的可选实施方式而不是为了限制本发明的范围。
实施例1:采用恒定外径导管套管制备近端和远端连接的支架组件
将壁厚度127微米、内径(“ID”)0.965毫米、外径(“OD”)1.168毫米的自扩张型形状记忆镍-钛支架装载到装载/焊接夹具ID 1.194毫米、OD 1.295毫米的装载套管中,并将OD 1.257毫米、壁厚4.5微米的包覆物装载到装载套管上。然后将包覆物的近端区域焊接于压缩的(crimpted)支架的近端区域。
使所得近端连接的包覆的支架组件滑入ID 1.193毫米、OD 1.295毫米的限制管远端。然后回缩装载/焊接夹具的装载套管,将包覆物的远端区域焊接于支架的远端区域,所述焊接点在硝酸溶液中钝化。
然后使所得近端和远端连接的包覆的支架组件完全滑入恒定外径的导管套管内。在本发明一个非限制性的实施方式中,冷却所述组件以便滑入。然后从恒定外径导管套管的近端插入ID 0.031”、OD 0.051”的推杆轴,从恒定外径导管套管的远端插入包括近端尖端的ID 0.018”、OD 0.027”的导线轴。或者,导线轴的插入可先于推杆轴的插入。
实施例2:采用渐细的导管套管制备近端和远端连接的支架组件
将壁厚度127微米的自扩张型形状记忆支架压缩到内径(“ID”)0.97毫米、外径1.17毫米。然后将该压缩的支架装载到装载/焊接夹具ID1.19毫米、OD1.295毫米的装载套管内,并将OD 1.257毫米、壁厚4.5微米的包覆物装载到装载套管上。然后将所述包覆物的近端区域焊接于压缩的支架的近端区域。
使所得近端连接的包覆的支架组件滑入ID 1.193毫米、OD 1.295毫米的限制管。然后,回缩装载/焊接夹具的装载套管,将包覆物的远端区域焊接于支架的远端区域,所述焊接点在硝酸溶液中钝化。
然后使所得近端和远端连接的包覆的支架组件完全滑入渐细的导管套管的远端,该导管套管远端ID 1.397毫米、OD 1.600毫米,近端渐细到ID 1.092毫米、OD 1.295毫米,所述渐细导管套管容纳预先装载的导管推杆轴,该导管推杆轴远端ID 0.737毫米、OD 1.295毫米,近端渐细到ID 0.737毫米、OD 0.991毫米。在本发明一个非限制性的实施方式中,冷却所述组件以便于滑入。然后从直径渐细的导管套管的远端插入ID 0.457毫米、OD 0.686毫米、包括防损伤尖端的导线套管。
虽然参照优选的实施方式描述了本发明,相关领域的普通技术人员将理解,本发明并不限于这些优选的实施方式,而是考虑包括所附权利要求书所限定的与本发明的精神和范围相一致的所有实施方式。
Claims (20)
1.一种植入式包覆支架,其包括:
a)支架,它具有近端区域和远端区域,所述近端区域具有由其伸出的至少一个膨大的近端元件,所述远端区域具有由其伸出的至少一个膨大的远端元件;
b)包覆元件,它具有近端区域和远端区域,其中,所述包覆物的近端区域以第一接合物连接于所述至少一个膨大的近端元件,所述包覆物的远端区域以第二接合物连接于所述至少一个膨大的远端元件。
2.如权利要求1所述的植入式医疗器件,其特征在于,所述支架和包覆物具有相容的透视收缩程度。
3.如权利要求1所述的植入式医疗器件,其特征在于,所述支架和所述包覆物各自由至少一种选自下组的物质组成:钛、钒、铝、镍、钽、锆、铬、银、金、硅、镁、铌、钪、铂、钴、钯、锰、钼及它们的合金、锆-钛-钽合金、镍-钛合金、钴-铬合金及不锈钢。
4.如权利要求1所述的植入式医疗器件,其特征在于,所述支架还包括分别从支架近端和远端伸出的至少一个连接元件。
5.如权利要求1所述的植入式医疗器件,其特征在于,所述支架的Af低于体温。
6.如权利要求4所述的植入式医疗器件,其特征在于,所述包覆物的Af约为60-100℃。
7.如权利要求4所述的植入式医疗器件,其特征在于,所述第一接合物和所述第二接合物还包括焊接点。
8.如权利要求7所述的植入式医疗器件,其特征在于,所述焊接点经钝化。
9.如权利要求1所述的植入式医疗器件,其还包括恒定外径的导管套管和导线套管。
10.如权利要求1所述的植入式医疗器件,所述器件还包括渐细的导管套管和导线套管。
11.一种制备权利要求1所述的植入式医疗器件的方法,所述方法包括:
a)将支架装载到装载套管的管腔内,使所述支架的第一端区域伸出所述装载套管的第一末端;
b)将包覆物装载到装载套管的末端上,并使包覆物滑动啮合到装载套管上,以使包覆物的第一末端与超出装载套管第一末端的支架的第一末端区域平齐;
c)将包覆物的第一末端区域与支架的第一末端区域以第一接合物连接,形成具有第一接合物的包覆的支架组件;
d)将具有第一接合物的包覆的支架组件装载到约束管内,使得包覆物的第二末端区域和支架的第二末端区域伸出约束管的末端;
e)将包覆物的第二末端区域以第二接合物连接支架的第二末端区域,形成所述植入式医疗器件。
12.如权利要求11所述的方法,其特征在于,所述步骤c)和e)还包括通过电阻焊接形成第一接合物和第二接合物的步骤。
13.如权利要求12所述的方法,所述方法还包括钝化所述包覆的支架组件的步骤。
14.如权利要求11所述的方法,所述方法还包括将包覆的支架组件从约束管转移到导管套管的步骤。
15.如权利要求11所述的方法,所述方法还包括以下步骤:
a)在将植入式医疗器件装载到导管套管内之前,将推杆元件设置到导管套管内;
b)使植入式医疗器件滑入导管套管,使其至少与推杆元件相邻近;和
c)将导线套管设置穿过推杆元件的中央孔,并穿过植入式医疗器件的中央管腔。
16.如权利要求13所述的方法,其特征在于,所述包覆套管还包括渐细的导管套管。
17.如权利要求15所述的方法,所述方法还包括:
a)将植入式医疗器件装载到导管套管内之前,将推杆元件设置到渐细的导管套管内;
b)使植入式医疗器件滑入渐细的导管套管,使其至少与推杆元件邻近;和
c)将导线套管设置穿过推杆元件的中央孔,并穿过植入式医疗器件的中央管腔。
18.一种使支架与支架包覆物连接的方法,所述方法包括以下步骤:
a)将支架装载到装载套管腔内,使支架第一末端区域伸出装载套管的第一末端;
b)将包覆物装载到装载套管的末端上,并使包覆物滑动啮合到所述装载套管上,以使包覆物的第一末端与伸出装载套管第一末端的支架的第一末端区域平齐;
c)将包覆物的第一末端区域与支架的第一末端区域以第一接合物连接,形成具有第一接合物的包覆的支架组件;
d)将具有第一接合物的包覆的支架组件装载到约束管内,使包覆物的第二末端区域和支架的第二末端区域超出约束管的末端;和
e)使包覆物的第二末端区域与支架的第二末端区域以第二接合物连接,形成所述植入式医疗器件。
19.如权利要求18所述的方法,其特征在于,步骤c)和e)还包括通过电阻焊接形成第一接合物和第二接合物的步骤。
20.如权利要求19所述的方法,所述方法还包括钝化所述第一和第二接合物的步骤。
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-
2006
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- 2006-08-30 WO PCT/US2006/033942 patent/WO2007027829A2/en active Application Filing
- 2006-08-30 CA CA2858266A patent/CA2858266A1/en not_active Abandoned
- 2006-08-30 AU AU2006284818A patent/AU2006284818C1/en not_active Ceased
- 2006-08-30 MX MX2008002762A patent/MX2008002762A/es active IP Right Grant
- 2006-08-30 JP JP2008529253A patent/JP5331479B2/ja not_active Expired - Fee Related
- 2006-08-30 CN CNA2006800316811A patent/CN101511306A/zh active Pending
- 2006-08-30 EP EP06802660A patent/EP1931281A4/en not_active Withdrawn
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2012
- 2012-04-12 US US13/445,131 patent/US8732935B2/en active Active
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2014
- 2014-05-27 US US14/288,284 patent/US20140343658A1/en not_active Abandoned
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN107488345A (zh) * | 2016-06-12 | 2017-12-19 | 上海微创医疗器械(集团)有限公司 | 装置、支架束缚装置以及支架束缚方法 |
WO2017215427A1 (zh) * | 2016-06-12 | 2017-12-21 | 上海微创医疗器械(集团)有限公司 | 束缚装置、支架系统以及束缚装置的使用方法 |
Also Published As
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WO2007027829A3 (en) | 2009-04-30 |
AU2006284818C1 (en) | 2013-04-04 |
AU2006284818B2 (en) | 2012-08-23 |
US8732935B2 (en) | 2014-05-27 |
CA2621299A1 (en) | 2007-03-08 |
WO2007027829A2 (en) | 2007-03-08 |
EP1931281A4 (en) | 2010-04-14 |
MX2008002762A (es) | 2008-04-07 |
US20070050017A1 (en) | 2007-03-01 |
US8187318B2 (en) | 2012-05-29 |
JP5331479B2 (ja) | 2013-10-30 |
AU2006284818A1 (en) | 2007-03-08 |
CA2858266A1 (en) | 2007-03-08 |
JP2009509569A (ja) | 2009-03-12 |
US20120197381A1 (en) | 2012-08-02 |
EP1931281A2 (en) | 2008-06-18 |
US20140343658A1 (en) | 2014-11-20 |
CA2621299C (en) | 2014-11-04 |
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