CN109414332B - 用于消化器官的多孔支架 - Google Patents

用于消化器官的多孔支架 Download PDF

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CN109414332B
CN109414332B CN201680087051.XA CN201680087051A CN109414332B CN 109414332 B CN109414332 B CN 109414332B CN 201680087051 A CN201680087051 A CN 201680087051A CN 109414332 B CN109414332 B CN 109414332B
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main body
stent
lesion
membrane
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CN109414332A (zh
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朴宪国
张峰硕
尹镐
文锺必
池少美
申庆燮
小林真
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MI Tech 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
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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
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    • 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
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
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    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
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    • A61F2/91Stents 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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    • 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
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    • 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
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • A61F2002/075Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
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    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2250/0023Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity
    • A61F2250/0024Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity made from both porous and non-porous parts, e.g. adjacent parts
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    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

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Abstract

本发明涉及一种用于消化器官的多孔支架,包括:主体,通过丝线之间的交叉形成多个单元格,并形成为中空的圆筒形状;以及皮膜,设置为与所述主体的内侧表面相接,其中,所述皮膜形成有至少一个排出孔。据此,用于消化器官的多孔支架设置于胆道内狭窄部位而使缩小的直径恢复,从而能够确保胆汁的排出路径,同时在主体的内侧表面设置皮膜,进而不仅防止狭窄部位的恶性肿瘤等病变由于生长而进入支架内部的情形以及再狭窄,而且还通过形成于皮膜的多个排出孔提供在胆道周围侧分支产生的体液的排出路径。

Description

用于消化器官的多孔支架
技术领域
本发明涉及一种用于消化器官的多孔支架。
背景技术
通常,支架用于扩张狭窄部位的用途,根据设置的各种器官及内腔的大小、性质及环境,符合其用途地形成,从而配备为解决由于内腔狭窄导致阻断或阻碍物质流动的问题,并且长时间保持内腔充分的直径。
这样的支架利用丝线(wire)构成,并且可以附加有覆盖主体的皮膜或涂覆膜的构成,从而在形成基本框架的主体及该主体的内侧或外侧不会形成物质从支架侧面向内部的移动。
同上所述,通过由形成主体的丝线的弯折而构成为特定图案的支架的单元格(cell)结构防止体内各种物质流入支架内部,对于为了更有效地恢复由于病变部位导致缩窄的内腔而配备的膜结构而言,通常在膜的整个表面上具有堵塞的封闭结构以达成上述的目的。
作为关于同上所述地具备覆盖利用丝线构成的主体的外侧或内侧表面而阻断来自侧面的物质移动的皮膜或涂覆膜结构的现有文献文献,有韩国授权专利公报第10-0448329号的“用于扩张内腔的支架”(以下,称为“现有技术”)。
首先,对于不具备皮膜结构的丝线单独型支架而言,其设置于内腔的狭窄部位,从而在初期持续执行扩张狭窄部位,但是随着恶性肿瘤等病变向设置于狭窄部位内的支架的丝线交叉部分开放而形成的单元格的空间生长,并且在设置后经过一定时间,则频繁出现再狭窄,同时发生丝线设置位置或结构的变形的现象。
并且,对于现有技术的具有以往的封闭型皮膜结构的支架而言,虽然阻止了由于病变的生长而进入支架内部的问题,但是在为了恢复如Y字形身体器官等具备从主要内腔分支的多个内腔的身体器官上的分支的内腔中的一个内腔中发生的狭窄部位而设置支架的过程中发生问题。
具体而言,设置于分支内腔中的一个内腔的支架的外侧面上的膜结构阻碍可能会从其余的分支内腔提供的体液及消化液等多种体内物质流入,从而可能发生该物质堵塞,最终导致在其余分支内腔的移动路径上发生梗阻的问题。
发明内容
技术问题
本发明为了解决上述问题而提出,本发明的目的在于提供一种具有如下技术的支架:设置于具有分支结构的内腔,使由于在分支内腔中一个内腔中发生的由于病变而造成的狭窄部位扩张,从而能够恢复内腔直径,同时确保从分支内腔中的其他内腔产生的体液的排出路径。
并且,本发明的另一目的在于提供一种如下的支架:与在设置的内腔发生的病变的生长关联,具有改善由于病变而造成的脱落防止性的程度,并且能够容易且有效地进行病变的摘除的技术。
技术方案
为了达成上述目的,本发明的用于消化器官的多孔支架,包括:主体,通过丝线之间的交叉形成多个单元格,并形成为中空的圆筒形状;以及皮膜,设置为与所述主体的内侧表面相接,其中,所述皮膜形成有至少一个排出孔。
在此,所述排出孔形成为小于形成于所述主体的单元格的大小。
并且,在所述皮膜设置于所述主体的内侧表面的情况下,所述排出孔形成为位于形成于所述主体的单元格内部。
并且,所述主体包括:主体部,形成为中空的圆筒形状;以及上部头部、下部头部,在所述主体部的两端部形成为相对于所述主体部扩张的直径,所述皮膜包括:主体皮膜部,位于所述主体部的内侧表面;以及上部头皮膜部、下部头皮膜部,位于所述上部头部、下部头部的内侧表面,其中,所述排出孔在所述主体皮膜部形成为至少一个。
有益效果
根据本发明,具有如下效果。
第一,设置于消化***内腔的狭窄部位而使缩小的直径恢复,从而能够确保通过该内腔的物质的排出路径。
第二,在主体的内侧表面设置有皮膜,从而能够防止狭窄部位的恶性肿瘤等病变由于生长而导致进入支架内部以及再狭窄的情形。
第三,即使设置于分支的Y字形结构的内腔中向一侧分支的内腔,也能够通过形成于皮膜的多个排出孔提供从向另一侧分支的内腔产生的体液的排出路径。
第四,当摘除被设置的用于消化器官的多孔支架时,形成于皮膜的多个排出孔的相位沿摘除方向而与支架同时移动,从而能够易于在摘除支架的过程中摘除通过多个排出孔进入并凸出的病变。
第五,当摘除并取出在狭窄部位发生的恶性肿瘤等病变时,可以通过将摘除装置***支架内部而进行手术,从而能够容易地摘除通过形成于皮膜的多个排出孔进入并凸出的病变。
第六,狭窄部位的预定部分通过形成于皮膜的多个排出孔***,从而能够提供用于防止被设置的支架整体的移动的更大的固定力。
附图说明
图1是图示根据本发明的用于消化器官的多孔支架的立体图。
图2是图示根据本发明的用于消化器官的多孔支架的主视图。
图3是图示根据本发明的用于消化器官的多孔支架的分解立体图。
图4图示了根据现有的丝线型支架的,基于狭窄部位的设置的狭窄部位的生长形态。
图5图示了根据现有的覆盖型支架及本发明的用于消化器官的多孔支架的,基于狭窄部位的设置的狭窄部位的生长形态。
图6至图8是图示根据本发明的用于消化器官的多孔支架的多种实施例的立体图。
符号说明
10:狭窄部位 20:现有的丝线型支架
23:现有的丝线型支架的丝线
33:现有的覆盖型支架的丝线 35:现有的覆盖型支架的皮膜
100、200、300、400:用于消化器官的多孔支架
110:主体 111:主体部
112:上部头部 113:下部头部
120:皮膜 121:主体皮膜部
122:上部头皮膜部 123:下部头皮膜部
125:排出孔
具体实施方式
参照附图对本发明的优选实施例进行更详细的说明,为了说明的简洁性,对已经公知的技术部分将省略或压缩。
<关于用于消化器官的多孔支架的构成要素及作用的说明>
参照图1至图3进行说明,本发明的用于消化器官的多孔支架100包括主体110及皮膜120。
主体110通过丝线之间的交叉形成多个单元格(Cell),并且形成为中空的圆筒形状。在此,更具体而言,如图3所示,主体110包括:主体部111,位于中央,形成为中空的圆筒形状;上部头部112,在主体部111的一端以相比于主体部111的直径扩张的直径延伸形成;以及下部头部113,在主体部111的另一端以相比于主体部111的直径扩张的直径延伸形成。
这样的主体110的形态以及由于构成这种的主体的丝线之间的交叉而开放形成的多个单元格结构并不限定于特定形态,可以多样地形成。
皮膜120设置为与主体110的内侧表面相接,这样的皮膜120形成有至少一个排出孔125。
在此,皮膜可以选自聚四氟乙烯(PTFE:Polytetrafluoroethylene)、硅、聚氨酯、聚酯、聚丙烯、聚乙烯、聚烯烃、高密度聚乙烯(HDPE:High Density Polyethylene)及膨体聚四氟乙烯(ePTFE:expanded-Polytetrafluoroethylene),但是还可以没有特别限定而在用于皮膜的公知材料范围内选择。
在此,如图3所示,皮膜120与主体110的构成相对应地通过如下要素形成:主体皮膜部121,位于主体部111的内侧表面;以及上部头皮膜部122和下部头皮膜部123,位于上部头部112和下部头部113的内侧表面。
并且,如图2所示,排出孔125形成为相比于形成于主体110的多个单元格而具有较小的直径的圆形孔,当皮膜120设置于主体110内侧表面时,如图2所示,以对应于单元格内部空间而布置的方式形成。
在此,排出孔125在皮膜120内形成的位置可以在以小于形成于主体110的单元格的大小且位于单元格内的方式形成的结构内多样地形成,更具体而言,优选地在主体皮膜部121上形成为至少一个。
同上所述,在主体皮膜部121上配备成具有以多种形成形态,从而具有形成于主体皮膜部121的整体或一部分的排出孔125的用于消化器官的多孔支架100、200、300、400可以如图6至图8所示地实现为多种实施例。
换句话而言,根据多种实施例,排出孔125的形成位置可以在主体皮膜部121上沿各种方向形成,但是优选地,排出孔125的大小形成为小于形成于主体110的单元格的大小,并且排出孔125与主体110结合时布置的位置形成于皮膜120内,从而在与主体110结合时位于单元格内。
例如,如图6所示,在根据第二实施例的用于消化器官的多孔支架200包括:皮膜220,在构成沿主体皮膜部221的中央圆周方向形成的预定列以及沿两端部的圆周方向形成的预定列的单元格内,以小于单元格的尺寸布置有排出孔225。
这样,以多种形成结构形成于皮膜120上的排出孔125相比于现有的用于消化器官的支架20能够执行多种作用,当执行在胆道内进行的支架***手术时,支架能够以更加改进的形态产生作用。
与如图4所示的现有的丝线型支架20相比,进行更具体的说明,对于现有的丝线型支架20而言,若如图4的(a)所示地设置在狭窄部位10而执行扩张,则如图4的(b)所示地形成有丝线23,以保持扩张后的预定直径。但是,在这种情况下,随着时间的经过,如图4的(c)所示,发生恶性肿瘤等病变的狭窄部位10逐渐生长,进而通过支架内单元格空间而进入内部,最终覆盖丝线23并发生再狭窄。
之后,为了阻断这样的狭窄部位10内的恶性肿瘤等病变进入支架内部并防止再狭窄,在现有的丝线型支架20设置覆盖型皮膜35,进而开发了覆盖型支架,然而,如图5的(a)所示,这样的现有的覆盖型支架则具有通过一定会发生的堵塞而阻断体液以及可从侧面提供的胆汁等消化液的排出路径的问题。
因此,在本发明的用于消化器官的多孔支架100中,排出孔125如图5的(b)所示地以预定的图案形成于皮膜120,能够使Y字形身体器官的分支内腔中的发生狭窄的内腔的狭窄部位扩张,从而不仅确保该内腔的排出路径,还减少过度的病变的进入,从而能够防止再狭窄,并且还能够确保从除了发生狭窄的内腔之外的其余分支内腔产生的体液以及通过侧面提供的胆汁等消化液的排出路径。
并且,如图5的(b)所示,形成于皮膜120的排出孔125中病变还未进入到内部的排出孔125A可以作为从对应于分支周围侧分支的内腔排出体液的空间,并且恶性肿瘤等病变的一部分进入的排出孔125B还执行作为摘除进入的病变的辅助空间的作用。
例如,在用于消化器官的多孔支架100被***之后,经过预定的时间,在通过拉动部件摘除支架的过程中,通过排出孔125B向支架内部生长并进入的病变部位以及由该病变产生的异物受到与支架的拉动联动而移动的排出孔125B的相位的影响,从而能够易于与用于消化器官的多孔支架100同时被摘除。
并且,除此之外,为了易于通过进入支架内部的手术用肿瘤摘除装置来实现针对已经向支架内部生长并进入的病变部位的切除并摘除,用于消化器官的多孔支架100的排出孔125B可以固定并确保手术部位,从而辅助摘除手术。
除此之外,恶性肿瘤等病变的一部分已经进入的排出孔125B通过向支架内部***一定部分的狭窄部位10内的病变,针对设置于用于消化器官的多孔支架100整体辅助狭窄部位10上的固定力,从而能够实现更高的移动防止性。
本发明公开的实施例的目的不在于限定本发明的技术思想,而是在于进行说明,本发明的技术思想的范围不限于这种实施例。保护范围应根据权利要求而解释,与其等同的范围内的所有技术思想应被解释为被包含于本发明的权利范围内。

Claims (1)

1.一种用于消化器官的多孔支架,其特征在于,包括:
主体,通过丝线之间的交叉形成多个单元格,并形成为中空的圆筒形状;以及
皮膜,设置为与所述主体的内侧表面相接,
其中,所述主体包括:主体部,形成为中空的圆筒形状;以及上部头部和下部头部,在所述主体部的两端部形成为相对于所述主体部扩张的直径,
所述皮膜包括:主体皮膜部,位于所述主体部的内侧表面;以及上部头皮膜部和下部头皮膜部,位于所述上部头部和下部头部的内侧表面,
所述主体皮膜部形成有多个排出孔,
在所述皮膜设置为相接于所述主体的内侧表面的情况下,形成于所述主体皮膜部的多个排出孔配备为位于在所述主体部形成的单元格内部并且小于形成于所述主体部的单元格的大小,
在所述主体皮膜部中的在设置支架时与设置支架的内腔的病变相接的一部分区域形成有所述多个排出孔,使得病变能够通过生长而进入,
在所述主体皮膜部中的在设置支架时不与设置支架的内腔的病变相接的一部分区域形成有所述多个排出孔,以能够确保从形成于设置支架的内腔周围的多个侧分支产生的体液的排出路径,
所述支架能够***于消化器官之后摘除,并且当摘除所述支架时,能够摘除通过所述多个排出孔进入的病变。
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