CN102860889B - 用于连接器官的邻近组织的支架 - Google Patents

用于连接器官的邻近组织的支架 Download PDF

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CN102860889B
CN102860889B CN201210217765.1A CN201210217765A CN102860889B CN 102860889 B CN102860889 B CN 102860889B CN 201210217765 A CN201210217765 A CN 201210217765A CN 102860889 B CN102860889 B CN 102860889B
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辛卿珉
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Taewoong Medical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/064Blood vessels with special features to facilitate anastomotic coupling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
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    • AHUMAN NECESSITIES
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    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1114Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00862Material properties elastic or resilient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00982General structural features
    • A61B2017/00995General structural features having a thin film
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1139Side-to-side connections, e.g. shunt or X-connections
    • 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
    • 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

Abstract

本发明公开了一种支架,用于连接病人的器官的邻近组织。支架包括空心圆柱体,其通过重叠方式编织超弹性形状记忆合金线形成,从而形成多个菱形开口,以及通过向外扩展空心圆柱体的各个相对端设置的翼部,并且在弯曲部分上把相对端翻转。翼部彼此面对,从而翼部在圆柱体的纵向拉紧。因此,翼部可相对于纵向弹性地向内或者向外移动,以响应于器官的邻近组织之间的距离或者器官的壁厚自动调整翼部之间的距离,从而翼部与器官的邻近组织紧密接触。

Description

用于连接器官的邻近组织的支架
技术领域
本发明通常涉及一种连接支架,其连接器官的邻近组织,例如病人的胆囊,胰腺等等,以便器官通过该支架彼此连通,从而形成一条通道,用于内窥镜操作,排泄或者分流胆汁或类似的物质,尤其涉及一种用于连接病人器官的邻近组织的支架,其包括以重叠的方式编织超弹性形状记忆合金线形成的空心圆柱体,以及通过向外扩展空心圆柱体的各个相对端而设置的翼部,并且在弯曲部分上把相对端翻转,以便翼部彼此面对,从而它们在空心圆柱体的纵向上施加张力,由此翼部相对于纵向向内或向外弹性移动,以响应于器官的邻近组织之间的距离或者器官的壁厚自动调整翼部之间的距离,并且与器官的邻近组织紧密接触,以便使用支架时不用考虑器官的邻近组织之间的距离或者组织的厚度,其不仅能保证支架固定到器官上而且能成为防止泄漏的密封件。 
背景技术
通常,支架插入病人的内脏器官,例如食道、胃、十二指肠、肠等等,从而形成通道。 
这样的支架包括空心圆柱体,其以重叠的方式编织超弹性形状记忆合金线形成,从而在空心圆柱体中形成多个菱形孔。因为空心圆柱体在径向可以弹性地膨胀和收缩,所以当该支架插入病人的内脏器官时,它可以在内脏器官中限定一条通道。 
最近,连接支架用来允许进入内脏器官,例如胆囊或者胰腺,在此很难直接进行内窥镜操作或者排泄或分流胆汁或类似的物质的操作。 
即,在刺穿器官(例如胆囊、胰腺等等)的邻近组织之后,支架插入穿刺孔,以便器官能相互连通。 
图1 阐明了在美国专利号6,620,122 中提出的一种常规的连接支架。如图1中所示,该常规的连接支架包括空心圆柱体2,其以重叠的方式编织超弹性形状记忆合金线形成,以及增加的直径部3,其设置在空心圆柱体2的相对端上,并具有哑铃状形状。在穿过病人的器官的邻近组织5 形成孔后,该支架插入孔中,从而增加的直径部3锁定到组织5中以阻止该支架从那里移开,从而使器官彼此连接。 
然而,该常规的连接支架的问题在于增加的直径部3设置在空心圆柱体2的相对端上,使得难以将支架插入在组织中形成的孔中。 
另外,在支架被制造之后,增加的直径部之间的距离是固定的。因此,当制备支架时,必须考虑在邻近组织之间的距离或者组织的壁厚。该支架可能不与组织弹性接触,因此在该支架和组织之间产生间隙,使得难以排泄或者分流胆汁或类似的物质。 
增加的直径部的每个边缘形成直角。这可能损坏器官的组织。 
图2示出了在美国专利2009-281557 中提出的一种支架,其用于克服图1的支架的问题。在图2的支架内,通过交叉方式编织合金线(例如,超弹性形状记忆合金线)形成空心圆柱体2。在空心圆柱体2已经插入在病人的器官中形成的孔之后,通过相对于纵向向内推空心圆柱体2的相对端的部分形成增加的直径部4,从而增加的直径部4锁定到各自的邻近组织5,因此防止该支架从那里移开。 
虽然图2中的支架能克服图1的技术问题,即该支架难以插入到组织中的孔中,由于增加的直径部之间的距离也是固定的,从而必须形成具有增加的直径的部分,以顾及邻近组织之间的距离或者组织的壁厚。由于这些原因,将具有增加的直径的部分与组织弹性、紧密接触是不容易的,因此在该支架和组织之间形成间隙,使得难以排泄或者分流胆汁或类似的物质。 
发明内容
因此,铭记在现有技术中发生的上述问题而作出本发明,并且本发明的目的之一在于提供一种支架,该支架包括以重叠的方式编织超弹性形状记忆合金线形成的空心圆柱体,以及通过向外扩展空心圆柱体的各个相对端而设置的翼部,并且在弯曲部分上把相对端翻转,从而病人的器官如胆囊、胰腺等的邻近组织由翼部支撑,其中翼部相对于圆柱体的纵向,向内或者向外弹性地移动,以基于器官的邻近组织之间的距离或者器官的壁厚自动调整翼部之间的距离,并且使它们与器官的邻近组织紧密接触,以便使用支架时不用考虑器官的邻近组织之间的距离或者组织的厚度。 
本发明的另一目的在于提供一种支架,其配置为响应于器官的邻近组织之间的距离或者器官的壁厚,翼部向内或者向外在纵向弹性地移动,以便翼部能保持与组织的持久、紧密接触的状态,凭此可以可靠地确保支架固定到组织以及其防止泄漏的功能。
为了实现上述目的,本发明提供一种支架,用于连接人体器官的邻近组织,其方式为支架插入在邻近组织上形成的孔中且其相对端支撑在各邻近组织上,该支架包括:空心圆柱体,以重叠的方式编织超弹性形状记忆合金线形成,从而形成多个菱形孔;以及通过向外扩展空心圆柱体的各自的相对端设置的翼部,并且在弯曲部分上把相对端翻转,翼部彼此面对,从而翼部在空心圆柱体的纵向上施加张力,凭此翼部相对于纵向弹性地向内或者向外移动,以响应于器官的邻近组织之间的距离或者器官的壁厚自动调整翼部之间的距离,从而翼部与器官的邻近组织紧密接触,
每个翼部的弯曲部分可以形成为圆形。 
每个翼部的端部可以向外弯曲以形成圆形接触部分,以便翼部的圆形接触部分与相应器官的组织紧密接触,从而防止翼部损伤器官。 
人工膜可以应用于圆柱体的外表面或者圆柱体和翼部的外表面,以将其内侧与外侧隔离。人工膜材料可以是对人体友好的聚四氟乙烯或者硅树脂。 
根据本发明的支架连接病人的器官(例如胆囊、胰腺等等)的邻近组织,以便形成一条通道用于内窥镜操作或类似的操作或者用于排泄或者分流胆汁或类似的物质。因此,本发明的支架包括空心圆柱体,以重叠的方式编织超弹性形状记忆合金线形成,以及通过向外扩展空心圆柱体的各自的相对端设置的翼部,并且在弯曲部分上把相对端翻转,从而器官的邻近组织由翼部支撑。翼部相对于圆柱体的纵向弹性地向内或者向外移动,以基于器官的邻近组织之间的距离或者器官的壁厚自动调整翼部之间的距离,并将翼部与器官的邻近组织紧密接触。因此,与常规技术不同,使用本发明的支架时不用考虑器官的邻近组织之间的距离或者组织的厚度。此外,因为支架能保持与组织的持久的、紧密接触的状态,能可靠地确保支架固定到组织以及其阻止泄露的功能。 
附图说明
将结合附图从下述详细说明更清楚地理解本发明的上述和其他目的、特征和优势,其中: 
图1是显示常规的连接支架的侧视图; 
图2是显示常规的连接支架的另一例子的侧视图; 
图3是显示根据本发明的优选实施方式的支架的透视图的照片; 
图4是显示图3的支架的侧视图的照片; 
图5是图3的支架的侧视图; 
图6是图5的支架的前视图; 
图7是图5的支架的部分侧面剖视图; 
图8是显示图5的支架的另一实施方式的侧视图; 
图9是显示图5的支架的又一实施方式的侧视图;以及 
图10 和11是显示本发明的支架的安装的侧面剖视图。 
具体实施方式
在下文,将参照附图详细描述本发明的优选实施方式。 
根据本发明的连接支架连接病人器官(例如胆囊、胰腺等)的邻近组织,其方式是邻近组织被刺穿形成孔,且支架插入到孔中,以便组织能相互连通,凭此形成一条通道,用于内窥镜操作或类似操作或用于排泄或者分流胆汁或类似物。 
如图3到7中所示,根据本发明的该连接支架包括空心圆柱体10,其以重叠的方式编织超弹性形状记忆合金线从而形成多个菱形孔,以及翼部15,其通过向外扩展空心圆柱体10的各自的相对端设置,并且在弯曲部分11上把相对端翻转。翼部15彼此面对,从而它们在空心圆柱体10的纵向上施加张力。翼部15相对于纵向弹性地向内或者向外移动,以响应于病人器官的邻近组织之间的距离或者器官的壁厚自动调整翼部15之间的距离,从而翼部15能与器官的邻近组织紧密接触。
每个翼部15的弯曲部分11弯曲形成圆面。弯曲部分11 在圆柱体10的纵向上可弹性地移动,直到圆形的弯曲部分11到达屈服点。 
每个翼部15的末端向外弯曲形成圆形接触部分16,以便于翼部15通过圆形接触部分16与病人器官的组织紧密接触,从而防止翼部15损害器官。 
人工膜30,其材料是对人体有好的聚四氟乙烯或者硅树脂,施加于圆柱体10或者圆柱体10和翼部15的外表面以将支架的内侧与外侧隔离。 
在附图中,附图标记50 表示形成在病人的器官中的孔,而附图标记100 和200分别表示病人的器官。 
现在将描述本发明的具有上述结构的支架的操作和作用。 
本发明的支架插入到孔50中,孔50形成在器官100和200(例如胆囊、胰腺等)的邻近组织中,以使器官100 和200彼此连接,以便它们可以相互连通。 
换句话说,如图10 和11中所示,在孔50穿过需要彼此连通的器官100 和200的部分形成之后,本发明的支架通过单独的支架插入设备插入到孔50中。这里,在将该支架插入到组织的孔50之前,在空心圆柱体10的相对端上设置的翼部15相对于纵向向外弹性移动以形成伸展的形状。此后,翼部15返回它们的初始状态,换句话说,在弯曲部分11上弹性地翻转,以便翼部15 能弹性地与器官的组织表面紧密接触。 
尤其,因为每个翼部15 可以在圆柱体10的纵向在圆形弯曲部分11上弹性地移动,直到弯曲部分到达屈服点,翼部15可以与器官的邻近组织紧密接触,而翼部15之间的距离取决于在器官的组织之间的距离或者器官的壁厚自动调整。 
此外,因为在圆柱体10的相对端设置的翼部15,响应于器官的邻近组织之间的不同距离或者器官的壁厚,在圆柱体10的纵向弹性地移动,并与组织弹性紧密接触,其不仅能可靠地确保支架固定到器官上且能保证防止泄漏的密封。
此外,在相对的翼部15弹性地与器官的邻近组织的紧密接触时,圆形接触部分16与组织接触,圆形接触部分16从翼部15的末端向外弯曲并且是圆形的。因此,可以阻止翼部15损害组织。 
同样地,本发明的支架穿过器官的邻近组织,并把它们彼此连接,从而形成一条通道。因此,当难以直接接近器官(例如胆囊、胰腺等)的病变部位来进行外科手术,例如,内窥镜操作时,本发明的支架使通过邻近器官接近病变部位成为可能,并且允许进行这种外科手术。 
此外,连接器官的邻近组织并使其彼此连通的支架,可以用于胆汁的排泄或者分流。在这种情况下,如图8 和9所示,由对人体友好的聚四氟乙烯或者硅树脂制成的人工膜30,施用于圆柱体10或者圆柱体10和翼部15的外表面,以便该支架的内侧可以与外侧隔离。 
如上所述,根据本发明的用于连接人体器官的邻近组织的支架包括空心圆柱体,其以重叠的方式编织超弹性形状记忆合金线形成,以及通过向外扩展空心圆柱体的各自的相对端形成的翼部,并且在弯曲部分上把相对端翻转。翼部彼此面对,从而它们在空心圆柱体的纵向上施加张力。从而,翼部相对于纵向弹性地向内或者向外移动,以自动调整翼部之间的距离,以适应于病人器官的邻近组织之间的距离或者器官的壁厚,从而翼部可以与器官的邻近组织紧密接触。因此,与常规技术不同,使用本发明的支架时不用考虑器官的邻近组织之间的距离或者组织的厚度。此外,本发明的支架可以维持与邻近组织的紧密接触状态,从而可靠地确保支架的固定且防止泄漏的功能。
虽然本发明的优选实施方式已经为了示例性目的公开,但是本领域技术人员会理解,可以在不背离权利要求中揭示的本发明的范围和精神的情况下,作出各种各样的修改、附加和替代。

Claims (5)

1.一种支架,用于连接人体器官的邻近组织,其方式是支架插入到邻近组织中形成的孔中,并且支架的相对端支撑在各邻近组织上,所述支架包括: 
空心圆柱体,其以重叠的方式编织超弹性形状记忆合金线形成,从而形成多个菱形孔;以及
通过向外扩展空心圆柱体相应的相对端而设置的翼部,并且在弯曲部分上把相对端翻转,翼部彼此面对,从而翼部在空心圆柱体的纵向上施加张力,凭此翼部相对于纵向弹性地向内或者向外移动,以响应于器官的邻近组织之间的距离或者器官的壁厚来自动调整翼部之间的距离,从而翼部与器官的邻近组织紧密接触,
其中,每个翼部的末端向外弯曲以形成圆形接触部分,以便于翼部的圆形接触部分与相应器官的组织紧密接触。
2.根据权利要求1所述的支架,其中,每个翼部的弯曲部分形成为圆形。
3.根据权利要求1或2所述的支架,其中,所述翼部在圆柱体的纵向弹性地移动,直到弯曲部分到达屈服点。
4.根据权利要求1所述的支架,其中,人工膜施用于圆柱体的外表面以将支架的内侧与外侧隔离。
5.根据权利要求1所述的支架,其中,人工膜施用于圆柱体和翼部的外表面以将支架的内侧与外侧隔离。
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