CN1203108A - 体腔扩张用固定模 - Google Patents

体腔扩张用固定模 Download PDF

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CN1203108A
CN1203108A CN98103808A CN98103808A CN1203108A CN 1203108 A CN1203108 A CN 1203108A CN 98103808 A CN98103808 A CN 98103808A CN 98103808 A CN98103808 A CN 98103808A CN 1203108 A CN1203108 A CN 1203108A
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lumen
fixed die
mentioned
expanding body
endless belt
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安圣淳
金澈生
崔盛弼
金泰亨
宋昊永
宋尚祐
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Solco Biomedical Co Ltd
Solco Surgical Instruments Co Ltd
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Priority claimed from KR1019970051355A external-priority patent/KR100240832B1/ko
Priority claimed from KR1019980000182A external-priority patent/KR100241822B1/ko
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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
    • DTEXTILES; PAPER
    • D04BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04CBRAIDING OR MANUFACTURE OF LACE, INCLUDING BOBBIN-NET OR CARBONISED LACE; BRAIDING MACHINES; BRAID; LACE
    • D04C1/00Braid or lace, e.g. pillow-lace; Processes for the manufacture thereof
    • D04C1/06Braid or lace serving particular purposes
    • DTEXTILES; PAPER
    • D04BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04CBRAIDING OR MANUFACTURE OF LACE, INCLUDING BOBBIN-NET OR CARBONISED LACE; BRAIDING MACHINES; BRAID; LACE
    • D04C1/00Braid or lace, e.g. pillow-lace; Processes for the manufacture thereof
    • D04C1/06Braid or lace serving particular purposes
    • D04C1/08Tulle fabrics
    • DTEXTILES; PAPER
    • D04BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04GMAKING NETS BY KNOTTING OF FILAMENTARY MATERIAL; MAKING KNOTTED CARPETS OR TAPESTRIES; KNOTTING NOT OTHERWISE PROVIDED FOR
    • D04G1/00Making nets by knotting of filamentary material
    • D04G1/02Making nets by knotting of filamentary material in machines
    • D04G1/06Making nets by knotting of filamentary material in machines using a single thread and a series of threads
    • 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
    • A61F2/0077Special surfaces of prostheses, e.g. for improving ingrowth
    • 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
    • A61F2/07Stent-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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8486Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs provided on at least one of the ends
    • 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
    • A61F2002/9528Instruments specially adapted for placement or removal of stents or stent-grafts for retrieval of 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
    • 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
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0054V-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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0073Quadric-shaped
    • A61F2230/0078Quadric-shaped hyperboloidal
    • DTEXTILES; PAPER
    • D10INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10BINDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2509/00Medical; Hygiene
    • D10B2509/06Vascular grafts; stents

Abstract

本发明公开了由单一长度的单线构成的圆筒形体腔扩张用固定模,它包括多个直线部、峰部及谷部的环带,上述峰部和谷部沿圆周方向,且配置在同一个平面上。在形成环带的谷部上铰接连结着下部环带的峰部。固定模还可包括用单线的非结合方式交差配置成螺旋状的主体部和含有多个弯曲部的上下端部。上端部的弯曲部与下端部的弯曲部的个数相同,主体的单线中的任何一个单线与沿纵方向、反方向配置的多个单线相互上下通过,通过这样的线间的交差点形成多个网孔。

Description

体腔扩张用固定模
在治疗上,希望提供为扩张狭窄体腔部的装置或通过体腔部维持开放部的装置。
例如,这样的场合,可用于由于食道癌(esophageal carcinoma)或由于食道癌转移(metastasis)发生的恶性食道狭窄及手术或由于腐蚀性食道炎的阻性狭窄症,也可用于胆汁系、血管系、泪管系、泌尿系及支气管系的狭窄症。
此时,作为为扩张狭窄部位并维持它的方法,已知有充气球扩张,但是该方法,由于是暂时的效果,所以必须反复操作,且对于严重的狭窄症患者是无效的。
作为另一个例子,对于食道狭窄症,为了维持开放部,在患者的食道中插入各种人造食道,但是由于它们没有收缩性和松弛性,所以在由于癌引起的狭窄部位,在将它们插入的过程中,食道破裂率高(30~40%)、食道破裂的死亡率也高。另外,由于人造食道的内径(10~12mm)狭窄,患者用它摄取食物时,困难很大。
作为克服上述问题的手段,在美国专利第4,214,587号中公开了使用固定模保持扩张的通路的装置。上述专利的装置,在扩张通路时,具有暂时的效果,但经过长时间后,依然存在体腔狭窄的问题。
为了克服这个缺点,在美国专利第4,580,568号中公开了用环带连结金属线形成闭锁锯齿状的连续直线部的固定模。由于这种形式的以往的固定模是插入到体腔内的,所以可弹性地压缩成小直径,以使直线部相并列,且互相接近地配置。另外,上述固定模的直线部对于通路壁加压,将其维持开放状态,可弹性地自身扩张成更大的第二直径。以往,证明了锯齿状固定模,在各种场合中是有很大用途的,但固定模的长度增加时,其性能有减少的趋势。
通常,自身扩张性固定模,可达到以下4种性能特性,即固定模加到体腔壁的扩张力、在固定模插入过程中,可压缩的最小直径、固定模对于患者身体内部的弯曲通路的适应性,及固定模不从患者内部的最初移动地点移动的稳定性。
以往,锯齿状固定模,由于直线金属部分对于弯曲的患者体腔难以适应,所以它是比较短的。对于这个缺点的解决办法是将多个短的固定模,以端部对端部地连接,作成一个长的锯齿状固定模组装体,将以往锯齿状固定模加以改进。这种改进的锯齿状固定模,在各种用途中,与以往的锯齿状固定模相比较,在性能上,是有改善的,但由于要求具有以往的锯齿状固定模和改进的锯齿状固定模的所有优点,所以依然在需求性能特性更高的,可伸长的自身扩张性固定模。
为了解决这样的问题,开发了很多种固定模,在其中,作为代表的,是沃尔(Wall)型固定模和库克(Cook)型固定模。
在PCT公开的手册第WO93/13825号中公开了库克型固定模的例子。上述专利的自身扩张性固定模,包括了在被分离成多个环带部的多个实质上具有直线金属线部分的伸长锯齿图形上弯曲的金属线和与上述环带部相连,交差的单线。上述锯齿图形是以固定模的中心轴作为中心,卷绕成螺旋状,大部分的环带是以螺旋状配置的齿形。上述固定模是多个单线相互锯齿形地连接,所以有复原力优良的优点,但有结构稳定性差的缺点。
在美国专利第4,655,771号公报中,公开了沃尔型固定模的例子。上述专利公开的固定模,是具有通过相互对向的本体端部的轴向移动可变化的直径的多个刚体,但包括由具有可挠性的线元件(thread element)构成的可挠性管形本体,上述各个线元件是以本体的中心线,作为共用轴,螺旋状地延伸。上述本体是由具有相同的绕线方向,但相互轴方向变位的第1元件和相互轴方向变位的,但在对向的绕线方向上,与上述第1元件交差的第2元件构成。上述第1及第2元件实质上是一边形成钝角、一边交差。上述固定模具有整体、均一、稳定的结构,但是复原力稍低的缺点。进而,以往锯齿形固定模,通常,在扩张时,使固定模的长度减少。
鉴于上述内容,本发明的主要目的,在于提供不仅通过固定模长度,达到有结构稳定性,并且复原力也优良的固定模。
本发明的另一个目的,在于提供在体腔内部不移动地、长时间地扩张狭窄体腔部位的,通过体腔部位,维持开放通路的体腔扩张用固定模。
本发明的又一个目的,在于提供在其长度中,实质上具有均一性能,以充分适应移植固定模的脉管系统内部的弯曲部的固定模。
本发明的再一个目的,在于提供可在患者的体腔内部,具有高稳定性的保持其位置的固定模。
为解决上述目的的本发明的一个实施例,提供了在圆筒形地形成具有多个锯齿状的环带的单一长度的单线构成的体腔扩张用固定模中,上述环带是具有多个直线部、峰部及谷部,上述峰部和谷部,配置在固定模的圆周方向,而且在同一平面上,在形成上述环带部的谷部,用铰接方式连结邻接的下部环带的峰部,上述邻接的下部环带的单线是从邻接的上部环带的终点直线部,向下方延长的单线的体腔扩张用固定模。
按照本发明的另一个实施例,可提供在由单一长度的单线构成的圆筒形体腔扩张用固定模中,包括上述单线以非结合方式交差地、螺旋地配置的本体部和具有多个弯曲部的上下端部,上述上端部的弯曲部,与下端部的弯曲部的个数相同,在本体的单线中,其中的任何一个是沿着纵方向,上下交差通过相反方向配置的多个单线,通过这样的单线间的交差点,形成多个网孔(mesh)的体腔扩张用固定模。
按照本发明的又一个实施例,可提供在单一长度的单线构成的圆筒形体腔扩张用固定模中,包括在上述固定模的两端部,锯齿形地卷挠上述单线的锯齿状部分和位于上述锯齿形状部分之间,螺旋状地卷绕上述单线的螺旋状部分,上述锯齿状部分,具有直线部、峰部及谷部,形成在固定模的圆周方向配置的环带,对于形成位于上述固定模端部的环带的锯齿状部分的谷部,是以铰接方式连结,形成邻接下部环部的锯齿状部分的峰部,上述螺旋状部分是用铰接方式连结固定模上端部锯齿状部分的最下部环带的谷部和形成固定模下端部最上部环带的锯齿状部分的谷部的体腔扩张用固定模。在上述螺旋状部分之间,可配置追加的锯齿状部分。
在上述实施例中,固定模的上端及下端,为了防止滑动,对着末端作成扩大直径的漏斗状,但可具有比本体直径大的直径。另外,希望单线是由镍-钛合金制造的。
以下,参照图,详细地说明本发明适宜的实施例的体腔扩张用固定模。
图1及图2概略地表示本发明实施例1的圆筒形固定模,但图中的固定模是由单一长度的单线(10)构成。圆筒形固定模的两端部,具有多个弯曲部(12,14)构成的末端部,上述的弯曲部(12,14),配置在共用的平面上。向这样的共用平面进行配置,如下所述,可作成在固定模的两端部,形成直径扩张部。在1996年8月13日,AN SEONG SEUN等批准的美国专利第5,545,211号公开的固定模具有在一定的螺旋角度下倾斜的多个弯曲部的末端部。
若参照图2,单线(10),沿着圆周方向,配置成锯齿状,形成环带。环带由多个直线部(20)和连结上述直线部(20)的峰部(22)(所谓本申请中使用的“峰部”术语是指从图中看到的,突出在上方的部分(及谷部(24)(所谓本申请中使用的“谷部”术语是指从图中看到,突出在下方的部分(构成的。这样连结的直线部(20)、峰部(22)及谷部(24),如图3所示,形成1个环带。本发明的实施例1的固定模是通过上下配置的多个环带形成的。
若参照图4,这样的环带,是通过位于上部的环带的谷部和位于下部的环带的峰部间的铰接(twist)方式结合而连结的。因此,为了容易地进行这样的连结,而且为了在固定模扩张和收缩时,防止形状变形,谷部实质上具有直线形态。
图12表示以下所述的本发明实施例3的一部分。特别是若参照图12中的锯齿状部分,形成第1环带(A)的单线,沿着第1环带的圆周方向,形成多个峰部(102)和谷部(104)。形成第1环带(A)的终点峰部(102L)的单线(106),向下方延伸,以形成第2环带(B)的谷部(104′),沿着第2环带(B)的圆周方向,形成多个峰部(102′)和谷部(104′)。此时,如上所述,第2环带(B)的峰部(102′),铰接方式与通过第1环带(A)的谷部(104)进行连结。
形成第2环带(B)的终点峰部(102′L)的单线(126)向下方延伸,以形成第3环带(C)的谷部(104″),沿着第3环带(C)的圆周方向,形成多个峰部(102″)和谷部(104″)。
本发明的实施例1的圆筒形固定模,是上述环带(A,B,C)反复进行的。实施例1的固定模,从终点峰部(102L,102L′),向下延伸,具有成为位于正下方的环带的初始点的单线(106、126)。上述An Seong Seun等的专利公开的固定模,由于环带是在规定的螺旋角度下配置,所以不具有这样的单线。即,上述的An Seong Seun等的专利的固定模,不能具有平行的末端部的理由是由于上部和下部环带的连结,是在规定的螺旋角度下进行的缘故。
参照图3及图4,对于本发明的实施例1的固定模的制造方法,加以详述。
如图3所示,将单一长度的金属线,折曲成凹凸状,以使其具有多个直线部(20),形成第1环带,在此,直线部(20)中,形成最初的直线部(22I),以使其具有一定的延长直线部(8)。而且,完成上述第1环的终点直线部(11F),不与最初的谷部(24I)连结,而向下方延伸。图中虽没有另外的表示,但在固定模的制造上,通常是使用芯轴的,峰部和谷部,是以一定的间隔,插入到芯轴的圆周面的销针为中心,进行弯曲的。
向下方延伸的直线部(11F),如图4所示,进行折曲,以形成正下方环带的最初谷部(24I′),而且,折曲的单线进行折曲,以形成多个谷部(24-′)及峰(22′),形成第2环带。第2环带的峰(22′)与对应的第1环带的谷部(24),分别以至少1次以上,在本实施例中,以2次铰接方式进行连结。重复上述的步骤,直到得到规定长的圆筒形固定模。终点环带的终点直线部(11F),与正上方的环带的最初谷部,以铰接方式连结以后,在规定的地点进行加工的。
图5及图6是表示本发明变形例的图,为了使图简单,不表示终点直线部。若参照图5,为了防止本变形例的环带两端滑动,对着末端,具有直径扩大的漏斗状的直径扩大部(42,42)。另外,图6表示除去具有比本体(40)直径大的均一直径扩大部分(44,44)的两端部,其他与图5所示的变形例实质上相同的固定模。图5与图6所示的固定模的锯齿状部分,由于与实施例1所示的锯齿状部分,实质上相同,所以省略了其说明。
图7是表示本发明的实施例2的固定模。图中所示的固定模,与本发明实施例1相同地使用单一长度的单线(10),但单线不配置成锯齿状,而配置成螺旋状。
若参照图7,实施例2的固定模,在上端部和下部端,具有多个弯曲部(32)在此,上端部的弯曲部与下端部的弯曲部的个数相同。而且,本体部分,进行螺旋状地配置,以使单线以非结合方式交差。其中任何一个单线,都是沿着纵方向,上下交差地通过相反方向配置的多个单线,通过这样的单线间的交差点,形成多个网孔(mesh)。初始单线(10I)和终点单线(10F)进行切断,以不突出在固定模的周边上,作为自由端部而存在着。
参照图8,对于本发明的实施例2的固定模的制造方法加以详细说明。为了便于理解,图8是将芯轴的圆周面展示成平面的图。而且,芯轴是将4个销针(A,B,C,D,a,b,c,d)分别上下配置而制成固定模的,但不受本实施例限制。
实施例2的固定模,由于使用单一长度的单线,所以使用夹子(图中未表示(,只固定初始单线的端部。实施例2的固定模中,单线是从A销针开始的。从A销针开始的单线,沿着芯轴,一边螺旋状地旋转,一边在下端部的销针(a,b,c,d)中,通过其中的任何一个。此时,单线通过无论哪一种螺旋旋转,都可决定到达的下端部的销针,按照设计者的意图,选择不同的螺旋旋转量,也可通过下端部销针(a,b,c,d)中的任何一个。
本实施例中,进行3/4次旋转,以达到d销针的情况,作为基准,加以说明。如上所述,从上部的A销针开始,到达d销针的单线,将d销针卷绕一半左右,再次对着上方,通过62地点。也可根据设计者的意图,多样地选择从d销针开始的单线,到达的上端部的销针,但若满足应该选择的前提条件,使单线可上下、反复地通过,而且使所有的销针可同等地通过,则所有的销针都可以通过。
本实施例中,通过d销针的单线,旋转一次,到达上端部的D销针。通过D销针的单线,再旋转3/4次,通过下端部的C销针,它再一次旋转,通过上端部的C销针。即,图中所示的右侧的62,64,66的地点,是与左侧的62,64,66的地点,在空间中相同的位置,按这样的顺序,通过b、B、a销针,到达作为初始地的A销针。
通过重复上述过程,上述半日线相互交差,形成多个交差地点(72,74)。在这样的交差地点(72,74),单线相互交差,具有稳定的结构。在上述交差点以后通过的单线,通过位于前面的单线的上部分时,使用(-)字改锥或编织针等器具,将位于前面的单线稍微提起,再将后面的单线,从其下面通过的方法进行的。
若重复上述的过程,使单线,依次经过所有的销针,回到初始地点,该端部可自由地位于固定模的适当地点。若上述过程结束,固定模在500℃下,进行30分钟的热处理。而后,除去打入芯轴的所有的销针,使固定模从芯轴脱离。
按照上述实施例2的固定模的制作过程中,为了便于理解,是以上下各设置4个销针的情况为基准的,但是上述的销针可以使用多少个也都可以作出相同的固定模。例如,使用10个销针,当芯轴以1圈、2圈、5/4圈等的转速旋转后,起始点的销针到达下端部的一定销针后,再次适当地向上方旋转,从起始点的销针跳过三个销针时,则可以相等地通过所有的销针。
另外,上述的销针是9个或11个样的奇数时,单线的一部分,有时可以不规则地交差配置,但起始点的销针和以后销针的间隔易于调节成2个、3个等的多个形式。
图9及图10是本发明其他变形例的图。参照图9,在本变形例的固定模的两端部,为了防止移动,向着末端,具有直径扩大的漏斗状的直径扩大部(42′、42′)。另外在图10中,具有比主体(40)直径大的均匀直径扩大部(44′,44′)的两端部,除此之外,与图9所示的变形例实质上是相同的固定模。图9及图10所示的固定模的螺旋部分实质上与实施例2所示的螺旋状部分相同,在此省略其说明。
图11是概略地表示本发明实施例3的圆筒形的固定模,但是所表示的固定模是由单一长度的单线构成的。固定模是由两端部的锯齿状部分(I,III)和中央的螺旋状部分(II)构成的。可是,对于本专业人员,在位于固定面的两端面部间的螺旋状部分的正中,还可以中锯齿状部分。
图12是表示图11所示的本发明实施例3的一部分。位于固定模上端的锯齿状部分(1)是由多个直线部(100)和连结着上述直线部(100)的峰部(102)及谷部(104)构成的,这样的直线部(100)、峰部(102)及谷部(104)形成一个环带(A、B或C)。在图示的实施例中,位于固定模上下端部的锯齿状部分(I,III),分别只构成三个环带,但这里不是对此限制。
连续环带(A、B、C)是通过位于上部环带的谷部和位于下部环带的峰部间的铰接而连结的。因此,为了容易地进行连结,而且为防止固定模的扩张及收缩时形状的变形,将谷部实质上作成直线形状。
参照图12,在位于固定模的上端的锯齿状部分(I)的最下部环带(C)的谷部(104″)上分别通过铰接方式连结着位于中央螺旋状部分(II)的线(114、115)。螺旋状部分(II)是由位于固定模上端的锯齿状部分(I)的最下部环带(C)的终点峰(102″L)长的线(112)与位于下端的锯齿状部分(III)的最上部环带的谷部铰接而形成的,进而,位于上端的锯齿形部分(I)的最下部环带(C)的其他谷部(104″)上以铰接方式连结的图形重复而形成的。形成螺旋状部分(II)的线(114、115)互相非结合状态地交差。
按照本发明的一个特征,由于使用单一长度的单线,所以体腔扩张固定模具有二个连结位于上下端部锯齿状部分带的端部(108)。因而,在固定模的圆周方向加以荷重时,不仅其形状难以破坏,而且配置在体腔内部时,或者配置后,也不会损伤体腔的组织。
形成第1环带(A)的单线,沿着第1环带的圆周方向形成多个峰部(102)和谷部(104)。形成第1环带(A)的终点峰部(102L)的线(106)为形成第2环带(B)的谷部(104′)而向下方延长,沿着第2环带(B)的圆周方向形成多个峰部(102′)和谷部(104′)。此时,上述的第2环带(B)的峰部(102′)以铰接方式与第1环带(A)的谷部(104)连结着。
形成第2环带(B)的终点峰部(102′L)的线(126)为形成第3环带(C)的谷部(104″)而向下方延长,沿着第3环带(C)的圆周方向形成多个峰部(102″)和谷部(104″)。
而且,形成第3环带(C)的终点峰部(102″L)的线(112)的铰接方式与位于固定模下端的锯齿状部分(III)的最上端谷部连结。当然,用本发明的固形模制造方法,先制造上端的锯齿状部分,在中央的螺旋状部分制造后,制造下端的锯齿状部分。
形成螺旋状部分(II)的线中,对着固定模下端的单线(114)和对着上端的单线(115)是向相反方向延长。这样的单线(114、115)沿圆周方向、卷绕成螺旋状时,通过线间的交差点形成多个网孔。
卷绕成这样螺旋方向的单线中,最终的线(116)在不带(C)的谷部(104″)以铰接方式连结后,向下端延长。向上述下端延长的线(116)用于形成下端的锯齿状部分(III)。
形成第1环带(A)的单线的开始端部(108)在设定的地点以铰接方式连结在固定的单线上。在图示的实施例中,开始端部(108)与第1环带和第2环带的单线延长部以铰接方式连结着,但本发明不受此限制。
在此这前,对于体腔扩张用固定模,是参照图12进行详细地说明,但位于固定模下端的锯齿状部分(III)实质上与上述的锯齿状部分(I)具有相同的结构,所以省略了其附加的说明。
本发明的实施例中,由于在固定模的两端部以铰接方式结合着多个由环带构成的锯齿状部分,所以可挠性弱,但复原力很是优良。而且配置在中央部分的螺旋状部分,不是由单线互相结合的配置,所以复原力弱,但可挠性非常优良。
以下,参照图13,对于本发明的变形则加以说明。
图13所示的体腔扩张用固定模,为防止固定模移动,在两端部形成的锯齿状部分(I′、III′),对着末端成为直径扩大的漏斗状(flare)。除此之外,与图11及图12所示的实施例是相同的。
漏斗状的锯齿状部分(I′、III′)以病变部位为中心上下位置移动时,固定模由于漏斗部分可以防止上下滑动的移位。另外,即使配置在弯曲的体腔中,形成在固定模中央部分的螺旋状部分不仅有充分的挠度,而且由于在两端部的锯齿状部分(I′、III′)而可以保持其复原力。
另外,两端部由于扩大成漏斗状的直径,所以可以防止固定模从弯曲的体腔中脱离。
图14是表示本发明的其他变形例。本变形例的固定模,为了比图13所示的实施例更确实地防止从体腔内滑动,而在两端形成均一扩大直径的锯齿状部分(I′、III′)。
如上所述,根据本发明的实施例3及其变形例,体腔扩张用固定模由于在两端部具有锯齿状部分、中央具有螺旋状部分,所以具备了有优良复原力的锯齿状部分的优点和有优良可挠性螺旋状部分的优点。因此,本发明的固定模,用插管那样的手段,配置在弯曲的体腔内时,由于两端部形成的锯齿状部分,可以维持其复原力,而保持中心部的开放状态。另外,上述体腔扩张用固定模,由于是由单一张度的单线构成的,所以配置在体腔内部、扩张后,其形状也不被破坏。
另外,上述体腔扩张用固定模,由于具有锯齿状部分或螺旋状部分的端部扩大的直径,所以可以防止从体腔内设定的部位脱离。
上述体腔扩张用固定模所使用的单线的材料对本专业人员是公知的。
例如,提出了使用含有49~58%(原子)的Ni-Ti合金的种种材料,而且希望在10℃或其以下温度、奥氏体和马氏体间完成变异的Ni-Ti合金。在室温的非应力状态下,这些超弹性合金存在于奥氏体结晶相中,按受应力时,显示出引起非线性弹性作用的应力诱发奥氏体-马氏体的结晶变异。
另外,公知的有从已知的nitinol alloy镍-钛合金形状的记忆合金来制造固定模。这样的固定模用体温加热时,可以复归到原来的形状。
在附图中,虽然没有特别表示,但为了防止通过固定模的网孔结构细胞进行增殖,也可以进行包覆(wrap)处理。包覆处理是用尼龙制造的网孔包住固定模或用聚合物、有机硅胶等材料的涂层,像软管型薄膜包住固定模。上述的结构在特许公报WO 92/06734号及美国专利第5,330,500号已经公开,本申请可以作为参照。
图15概略地表示在治疗病变部位后,回收固定模的回收装置。图中表示的回收装置一般是提供给固定模的一个端部的内部。回收装置是由沿着固定模(50)的园周方向与配置的单线相连结的多个因尼龙线(52)和用上述尼龙线(52)支持的回收尼龙线(54)而构成的。尼龙线(52,54)最好用钓鱼线那样的高强度的线。
附图的简单说明
图1表示本发明实施例1的体腔扩张用固定模结构的斜视图。
图2表示本发明实施例1的体腔扩张用固定模结构的斜视图。
图3说明制造实施例1固定模过程的图。
图4说明制造实施例1固定模过程的图。
图5表示变形例的斜视图。
图6表示变形例的斜视图。
图7本发明实施例2的固定模的斜视图。
图8是实施例2的固定模的制造过程,使固定在芯轴上的销针平面化的图。
图9表示其他变形例的斜视图。
图10表示其他变形例的斜视图。
图11本发明的实施例3的固定模的斜视图。
图12锯齿状部分和螺旋状部分的细节放大图。
图13表示本发明其他变形例的斜视图。
图14表示本发明其他变形例的斜视图。
图15概地表示提供在固定模一端部的回收装置的斜视图。
图中的符号
10、114、126:单线
12、14:弯曲部
20、100:直线部
22、22′、102、102′、102″:峰部
24、24′、104、104′、104″:谷部
I、III:锯齿状部分
II:螺旋状部分

Claims (22)

1.体腔扩张用固定模,由单一长度的单线形成的具有多个锯齿状环带的圆筒形的体腔扩张用固定模,其特征在于上述环带具有多个直线部、峰部及谷部、上述峰部和谷部在固定模的圆周方向,而且在同一平面上配置、在形成上述环带的谷部上以铰接的方式连结相邻下部环带的峰部、上述邻接下部环带的单线是从邻接上部环带的终点直线部向下方延长的单线。
2.权利要求1所述的体腔扩张用固定模,其特征在于固定模的上端部及下端部,为了防止滑动,形成对着末端具有直径扩大的漏斗状。
3.权利要求1所述的体腔扩张用固定模,其特征在于固定模的上端部及下端部具有比本体直径大的直径。
4.权利要求1~3中任何一项所述的体腔扩张用固定模,其特征在于上述的单线是用镍-钛合金制造的。
5.权利要求1~3中任何一项所述的体腔扩张用固定模,其特征在于上述的固定模上用可挠性材料被复或者进行包覆处理。
6.权利要求1~3中任何一项所述的体腔扩张用固定模,其特征在于上述固定模的一个端部具有回收装置。
7.权利要求6所述的体腔扩张用固定模,其特征在于上述回收装置是由高强度的线制造的。
8.体腔扩张用固定模,是由单一长度单线构成的圆筒形体腔扩张用固定模,其特征在于包括由上述单线,以非结合方式交差地配置成螺旋状的主体部和具有多个弯曲部的上下端部、上述上端部的弯曲部与下端部的弯曲部的个数相同,主体线中的任何其中一条单线沿着纵向,并相互上下通过相反方向配置的多个单线,这样通过单线间的交差点形成多个的网孔。
9.权利要求8所述的体腔扩张用固定模,其特征在于固定模的上端部及下端部,为了防止滑动,形成对着末端具有直径扩大的漏斗状。
10.权利要求8所述的体腔扩张用固定模,其特征在于固定模的上端部及下端部具有比本体直径大的直径。
11.权利要求8~10中任何一项所述的体腔扩张用固定模,其特征在于上述的单线是用镍-钛合金制造的。
12.权利要求8~10中任何一项所述的体腔扩张用固定模,其特征在于上述的固定模是用可挠性材料被复或者进行包覆处理。
13.权利要求8~10的任何一项所述的体腔扩张用固定模,其特征在于上述固定模的一个端部具有回收装置。
14.权利要求13所述的体腔扩张用固定模,其特征在于上述回收装置是由高强度的线制造的。
15.体腔扩张用固定模,是由单一长度的单线构成的圆筒形体腔扩张用固定模,其特征在于包括在上述固定模的两端部上由上述单线卷绕成锯齿状的锯齿状部分和位于上述锯齿状部分间,上述单线卷绕成螺旋状的螺旋状部分、上述锯齿状部分具有直线部、峰部及谷部,形成沿固定模的圆周方向配置的环带,在位于上述固定模端部的环带的锯齿状部分的谷部与形成相邻下部环带的锯齿状部分的峰部铰接、上述螺旋状部分是与固定模上部端部的锯齿状部分的最下部环带的谷部和固定模的下端部的最上部环带的锯齿状部分的谷部是以铰接方式连结的。
16.权利要求15所述的体腔扩张用固定模,其特征在于在上述螺旋状部分间配置追加的锯齿状部分。
17.权利要求15所述的体腔扩张用固定模,其特征在于固定模的上端部及下端部,为了防止滑动,形成对着末端具有直径扩大的漏斗状。
18.权利要求15所述的体腔扩张用固定模,其特征在于固定模的上端部及下端部具有比主体直径大的直径。
19.权利要求15~18中任何一项所述的体腔扩张用固定模,其特征在于上述的线是用镍-钛合金制造的。
20.权利要求15~18中任何一项所述的体腔扩张用固定模,其特征在于上述的固定模是用可挠性材料被复或者进行包覆处理。
21.权利要求15~18所述的体腔扩张用固定模,其特征在于上述固定模的一个端部具有回收装置。
22.权利要求21所述的体腔扩张用固定模,其特征在于上述回收装置是由高强度的线制造的。
CN98103808A 1997-02-04 1998-02-04 体腔扩张用固定模 Pending CN1203108A (zh)

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