CN1398171A - 用于修复动脉的器具 - Google Patents
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Abstract
一种用于穿透植入物和动脉壁,以便将植入物固定在动脉上的器具。所述器具具有一个带有支撑面的的中间段和两个带有末端的细长件,当器具穿透植入物和动脉时,所述支撑面抵靠在植入物的内壁上,所述细长件与动脉的外壁接触。细长件被偏移,从而促使支撑面进入植入物并将植入物固定在动脉上。
Description
本发明涉及一种用于将植入物固定在动脉内的器具,并且尤其涉及一种用于外科接合活体组织或将植入材料与活体组织接合的器具。特别是本发明优选利用最大限度地减少侵害性的或内腔手段用于将血管植入物与动脉壁接合。
在WO 92/05828中披露了一种丝状缝线,该缝线由一开放的丝环构成,该丝环的两端搭接。丝材形成的环可以完全或部分地被矫直,其一端被锐化并且整个器具被驱动穿过毗邻的组织。丝材具有弹性或形状记忆特性,当在固定位置时该弹性或形状记忆特性将使其变形形成环形,从而将组织牵拉在一起。
在WO 00/07506中披露了对本设计的改进(与本申请是同一申请人,在本申请的优先权日后公开),其中一对丝件具有形状记忆特性,该形状记忆特性将导致其在展开后形成‘H’形。该形状具有对称的优点,该对称将保证在植入后器具的定向保持稳定不变。另一优点是在植入后器具的整个宽度将增大。此点将减少器具被推移离开其植入位置的可能。这两个优点对动脉内植入的关键的应用尤为重要。
在WO 00/07506披露了对设计的要求,该要求是,丝件相互接合位置处的器具部分应力求位于动脉壁和植入物内,而器具的分叉部分应分别由腔和血管两侧伸出动脉壁和植入物。此要求将导致当器具在动脉和植入物内穿移时,丝件对必须沿其长度保持相互接触。如果不是这样,则器具将不能完全穿移过结构或器具将使内部的材料移位(由于其宽度的增大)。此点将制约相应的输送系统的设计并将增大器具错位的风险。该错位将会给患者带来严重的后果。
根据本发明的第一方面,提出一种将植入物固定在动脉上的器具,所述器具包括一具有一个支撑面的中心段和两个由中心段延伸的细长件,细长件被弹性偏移成开放状态,其中细长件的端部远离中心段并相互间隔开,其中可以克服所述偏置,将细长件移动成闭合状态,此时所述末端与开放状态相比相互贴近,其中所述末端用于当器具到达动脉腔内时穿透植入物和动脉壁,从而促使细长件穿过植入物和动脉壁,以便使支撑面抵靠在植入物上,从而在使用状态时植入物被固定在位于所述支撑面与细长件的末端之间的动脉上,同时细长件的弹性偏移将促使支撑面抵靠在植入物上。
所述植入物系指任何用于对包括动脉和静脉等活机体内的受损或薄弱的导管的修复或支撑的材料。植入物可以由天然组织或编织、模压或挤压成型的合成聚合物或弹性材料构成并且可以是管状或扁平状(即补丁片状)。还可以是斯坦特固定模,即斯坦特-植入物。
保持在动脉腔内侧的支撑面的措施的优点是,细长件可以相互偏移,形成开放状态,从而使其穿过植入物和动脉壁,这是因为不会出现在已有技术中出现的植入物或动脉壁被移位的现象。根据一优选实施例,当器具就位时,在被保持在动脉腔内的中间段上没有突出部分,从而仅会导致产生很小的阻塞,因而液体在动脉内流动顺畅。
根据一优选实施例,器具由弹性丝材构成,中间段是由丝材形成的环,其中环的外表面形成支撑面。环优选由丝材绕制的半个或两个圈,并且更为优选的是由大约一圈半构成。
环措施是一种有效的和灵巧的机械解决方案,其中可以由一根丝材形成器具;可以实现对细长件的偏置;可以实现支撑面,所述支撑面向背离植入物壁方向弯曲,从而可以减少对植入物的损坏;并且还提供了与牵引线接合的位置,从而可以使器具在动脉腔内进行移位。
在一特殊的优选实施例中,形成的环可以将细长件移动到将环闭合的闭合位置。此点将增大细长件的弹性偏移并避免当器具被移动成闭合状态时环被打开。
当器具处于开放状态时,细长件大致设置在同一平面上,并且器具的优选设计应使由中间段到所述末端中的一个末端的矢量与由中间段到所述末端的另一个末端的矢量之间的最小的角在开放状态下为150至180°。很明显,在使用状态器具穿透植入物和动脉时,很可能根据植入物和动脉的厚度,器具处于闭合与开放状态之间的某一状态下。
根据本发明的第二个方面,提出一种将植入物固定在动脉上的方法,包括:备有一个上述定义的器具;将细长件移动到闭合状态;沿动脉输送器具,直至到达植入物的内侧;驱动细长件的末端进入植入物和动脉,使移动件脱离闭合状态并向开放状态移动,同时细长件的末端穿透植入物和动脉,和连续驱动器具穿过植入物和动脉,直至支撑面抵靠在植入物壁上,其中植入物被器具固定在动脉上。器具优选在一导管内沿动脉进行输送,其中细长件的末端在前和中间段在后。
在本申请中披露的改进的设计正好与PCT/GB99/02544的要求相反,即当器具的细长件对在植入物和动脉的壁上穿移时是分开的并且在动脉内侧保持分离。另一改进是,细长件对的相互连接处的器具部分位于动脉腔内,而不是在其壁上。因此并不需要有用于将器具的细长件对进行固定接触的分配系统。另外也不需要在动脉壁上设置单独一个较大的固定细长件对的接合部分的孔。改进的设计通过此方式可以更为可靠地实现对器具的顺利的输送并减少对动脉壁损伤的风险。
所述器具可以由包括金属和塑料等大量的材料构成,并且可以由单独的坯料制作,可以由线材卷切割而成,也可以采用模压、铸造或采用其它方式制成。
其优选实施例的典型的尺寸如下:
尺寸 | 最大值 | 最小值 | 优选值 |
丝直径 | 1.0mm | 0.1mm | 0.5mm |
丝长度 | 50mm | 4mm | 25mm |
如上所述,器具优选由带有一个环的单根丝材构成。但根据另一实施例,所述器具也可以由两根丝材构成,所述丝材被强制相互平行,每根丝材具有两个端部,所述丝材在一个端部或接近一个端部的位置通过熔焊、钎焊等被相互连接在一起。线材的第二自由端被锐化,形成具有斜削、套针、锥形、菱形等的尖。丝材可以由具有弹性或热或诸如镍/钛形状记忆合金等超弹性形状记忆性能的材料制成,从而使其不受限制的形状是一个弯曲的‘Y’或海鸥翼形,其中由接合在一起的丝材形成‘Y’的基座,构成支撑面。
该实施例的典型的尺寸如下:
尺寸 | 最大值 | 最小值 | 优选值 |
丝材直径 | 1.0mm | 0.1mm | 0.5mm |
焊接长度 | 5mm | 1mm | 2mm |
线材长度 | 25mm | 4mm | 8mm |
使用时,可以将器具插入管件内,使其尖的端部首先从管内露出。管件对器具的丝件进行制约,使其几乎相互平行,但应保证在尖端穿透组织前丝件的尖端略有分开。器具被逐渐由管件内被顶出并且器具的尖端被弹簧重绕或热形状恢复所驱动,当器具由管件内露出时,器具的尖端相距越来越远。当对器具在动脉内输送后,将血管植入物与动脉壁接合时,器具的设置应使其焊接的结合部位于动脉腔内并且器具的尖端穿透植入物和动脉的壁并且由器具的中心线开始弯曲。
丝件之间的连接部可以包括一个套件,所述套件可实现强度、射线不透性和避免器具穿过动脉壁的机械止挡。
下面将对照附图对本发明的多个优选实施例加以说明。图中示出:
图1示意示出作为本发明已有技术的PCT/GB99/02544披露的器具;
图2示出本发明的器具的实施例,其中所述器具被制约在一个输送管内;
图3为处于开放状态的图2所示的器具的立体图;
图4为通过血管植入物和血管壁植入的图2和3所示的器具的剖面图;
图5为根据本发明的另一方案的器具的立体图;
图6为通过血管植入物和动脉壁植入的本发明的再一方案的器具的立体图;
图7示出本发明一优选实施例;和
图8为图7所示的器具的剖面图,其中器具设置在输送管内。
图1示出根据已有技术的固定器1(如在WO 00/07506中所述),所述固定器具有一个中间段2和四个腿件3。如图1A所示,中间段1精确地定位跨接动脉壁4和植入物壁5。该定位是由穿过植入物壁5和动脉壁4的引导腿3实现的,腿件露出动脉壁4时才相互分离。
图1B示出固定器的不正确的设置,该不正确的设置是由于穿过动脉壁4过程中腿件对3分离造成的。从图中可以看出,如果再将固定器前移一点,则固定器1将使材料的中心部分脱离植入物壁5和动脉壁4。
图2至4示出本发明的一个实施例,其中固定器10具有两个腿件11,两个腿件被相互焊接在套件12上,所述腿件终结在锐端13上。腿件11弹性地偏移成如图3所示的八字型,但也可以相向弯成如图2所示的轴向状态,其中固定器10被制约在输送导管14内。图4示出处于使用状态的固定器10,其中植入物5被固定在位于固定器10的套件12与端部13之间的动脉壁4上。从图中可以看出,腿件11被分成开放八字形穿过植入物5和动脉4。
图5示出由一根单独的弹性丝材构成的固定器10的变型方案,所述丝材被弯曲成“海鸥翼”形,其中两个腿件从中心段22分开并终结在锐端23上。很明显,固定段20的作用方式与图3的固定器10相同。
图6示出替代将植入物5固定在动脉4上的再一个变型方案。固定器30具有两个腿件31,所述腿件31连接在由不透射射线的材料构成的套环32上。该套环可以使外科医师实现对固定器的定位和跟踪。腿件31如上所述终结在锐端33上。
图7和8示出用于将材料与身体组织接合的外科固定器40。固定器40由一定长度的高弹性的丝材构成并由一个环状部分42和两个腿件41构成。腿件的端部43被锐化。环部分42是一个绕1.5圈的环。腿件41由环部分42的每一端在切向成弧形延伸。腿件41的中心距在环部分42的每一侧为几毫米,确切地说在弧顶上,从而两个弧的切向连接距环部分几毫米。由腿件41形成的弧的平面是平行的。腿件被锐化形成锥形尖43。腿件41为半圆状。
固定器40可弹性变形,使腿件41相互叠合在一起并如图8所示被制约在导管14内,其中腿件41的端部43指向导管14的末端。在导管14的内侧可滑动地安装有一个定位管50,定位管在环42的后面。定位管50的内孔小于环42的宽度,所以环不能进入定位管50内。而且定位管50长于导管14,并可通过调整端部51的位置对其进行移动。一具有一定长度的柔性牵引线70穿过环42和定位管50,柔性牵引线的两端由定位管50伸出并相互连接成把手71。通过对定位管50的推动和对把手71的牵拉的结合可实现固定器40对导管14相对位置的调整。
固定器40用于通过将导管14的末端抵住该双层材料并基本垂直于双层材料的定位实现对双层材料的固定。通过推动定位管50使固定器40前移穿过导管14,直至腿件41的尖端突伸并穿过材料,形成一小型的孔。一旦腿件41穿透材料,将恢复其弧形形状(开放状态)。双层材料接着将被固定在一侧的环42和在另一侧的腿件41端部43之间。通过拉动牵引线的一端去掉牵引线70。
Claims (20)
1.一种用于将植入物固定在动脉上的器具,该器具包括:
一个中间段,所述中间段具有一个支撑面,和两个细长的由中间段向外延伸的件,所述细长件被弹性地偏移成一开放的状态,其中细长件的端部远离中心段并相互间隔开,
其中细长件可克服所述偏移移动形成一闭合状态,在该状态时所述末端与开放状态相比相互贴近,
其中当所述器具在动脉腔内时,所述末端穿透植入物和动脉壁,从而促使细长件穿过植入物和动脉壁,以便使支撑面抵靠在植入物上,
从而在使用状态时利用细长件的弹性偏移促使支撑面抵靠在植入物上,使植入物固定在位于所述支撑面与细长件的末端之间的动脉上。
2.按照权利要求1所述的器具,另外还包括用于与牵引线接合的装置。
3.按照权利要求2所述的器具,其中所述装置是在中间段上形成的环。
4.按照上述权利要求中任一项所述的器具,其中器具由弹性丝材构成,中间段是由丝材构成的环,其中环的外表面构成支撑面。
5.按照权利要求4所述的器具,其中所述环是由丝材绕制半圈到两圈构成的。
6.按照权利要求4所述的器具,其中所述环是由丝材绕制一圈半构成的。
7.按照权利要求4至6中任一项所述的器具,其中形成的所述环应使细长件被移动到闭合位置,对环进行闭合。
8.按照上述权利要求中任一项所述的器具,其中当器具处于开放状态时,细长件大致设置在同一平面上。
9.按照上述权利要求中任一项所述的器具,其中在由中间段到所述末端中的一个末端矢量与由中间段到所述末端的另一个末端的矢量之间的最小的角在开放状态时为150至180°。
10.按照权利要求9所述的器具,其中所述角大约为180°。
11.按照上述权利要求中任一项所述的器具,其中所述支撑面向背离其与之接触的植入物壁的方向弯曲,以便减小对植入物的损伤。
12.按照上述权利要求任一项所述的器具,其中只有两个由中心段延伸的细长件。
13.一种用于将植入物固定在动脉上的器具,包括一个用于对植入物壁进行支撑的的支撑部分,和两个由支撑部分延伸的的细长件,远离支撑部分的细长件的端部用于穿透植入物和动脉壁,细长件被弹性偏移成一固定状态,从而在使用状态时植入物被固定在细长件的支撑部分与末端之间的动脉上,并且细长件可移动成轴向状态,其中所述细长件被基本设置在一轴线上,从而使器具可以沿动脉进行输送。
14.按照权利要求13所述的器具,其中支撑部分包括与牵引线接合的装置。
15.按照权利要求14所述的器具,其中所述装置是一个在支撑部分上形成的环。
16.一种用于将植入物固定在动脉上的方法,包括:备有一种按照权利要求1至12中任一项所述的器具;将细长件移动成闭合状态,沿动脉输送器具到达植入物壁的位置,驱动细长件的末端进入植入物和动脉,当细长件的末端穿透植入物和动脉时,使细长件脱离闭合状态并向开放状态移动,并且继续驱动器具穿过植入物和动脉,直至支撑面抵靠在植入物壁上,从而通过器具使植入物固定在动脉上。
17.按照权利要求16所述的方法,其中沿动脉输送在导管内的器具,其中细长件的末端在前面并且中间段在后面。
18.按照权利要求16或17所述的方法,包括在对器具沿动脉进行输送前将牵引线与器具接合和在利用器具将植入物固定在动脉后去掉牵引线的附加的步骤。
19.按照权利要求18所述的方法,还包括在细长件穿透植入物之前或之后,通过拉动牵线将细长件移动成闭合状态,实现器具在植入物上的重新定位的步骤。
20.一种用于将植入物固定在动脉上的方法,包括:备有一种按照权利要求13至15所述的器具;将细长件移动成轴向状态;沿动脉输送器具,直至到达植入物内;驱动细长件的末端进入植入物和动脉,使细长件脱离轴向状态并移动成固定状态,同时细长件穿透植入物和动脉,并且继续驱动器具穿过植入物和动脉,直至支撑面抵靠在植入物壁上并且器具处于固定状态。
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ZA200207060B (en) | 2003-09-29 |
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ES2349459T3 (es) | 2011-01-03 |
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GB2359024A (en) | 2001-08-15 |
PT1255491E (pt) | 2010-12-02 |
CA2400016A1 (en) | 2001-08-16 |
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