CN1102856C - 扩张器及其制造方法 - Google Patents
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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
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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
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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
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- A61F2002/91541—Adjacent bands are arranged out of phase
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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
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- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
Abstract
一种扩张器和制造该扩张器的方法。扩张器开始时具有平的网纹和网纹侧边相连接的连接点。方法包括的步骤是a)在金属片上切割扩张器网纹,b)在所述金属片上设置一组对准孔;c)使所述网纹变形为管形,而使所述啮合槽对与所述啮合凸起对啮合;d)切断所述梁;e)使每个所述啮合槽附着在与之啮合的啮合凸起上,以形成所述可扩张的扩张器。当扩张器扩张时扩张器上基本上没有什么部分会伸入扩张器的内腔。
Description
本发明涉及扩张器及其制造方法。
扩张器在该技术领域是公知的。它们通常由一个圆筒形的金属网构成,当从内部施压时该圆筒形金属网可以扩张。作为另一种选择,它们也可由缠绕成圆柱形的线网构成。
正如授予Palmaz的美国专利4,776,337中所描述的,可以通过用激光切割一薄壁金属管来生产圆筒形金属网。除了网的网线和曲线之外,激光切除所有部分。
US4,776,337的方法适用于相对较大形状的网和网线较粗的网,然而,对于更精细和/或更复杂形状的网来说,激光的点尺寸就太大了。
所以,本发明的目的是提供一种扩张器制造方法,用它可以生产更为精细和/或复杂形状的扩张器。
该方法涉及首先在一块薄金属片上形成平面形式的所需扩张器网纹。只要在商业上可行,可以采用任何适当技术,例如将网纹蚀刻在金属片上或用很细的激光切割,或采用任何其它技术来形成网纹。
一旦金属片切割完毕,就将其变形以使其边缘相遇。为了从平的金属片变为圆筒形扩张器,将金属片卷起直到边缘相遇。例如通过点焊将边缘相遇的地方连接在一起。然后,用机械或电化学方法抛光扩张器。
结合附图,从下面的详细描述中可更充分地了解本发明,附图中:
图1是根据本发明的扩张器制造方法的流程图;
图2A,2B和2C示出了根据图1所示的方法蚀刻在一平金属片上的三种不同的扩张器网纹;
图3示意性地示出了一被变形的扩张器,用于了解图1所示的方法;
图4示意性地示出了用图1所示的方法形成的扩张器;
图5A和5B是侧视图和俯视图,分别示出了图4所示扩张器的一个连接区;
图6是一侧视图,示出了图4所示扩张器的一个连接区,在该连接区用钉接方法连接;
图7示出了一块金属片,其上带有多个根据本发明加工的网纹;
图8详细示出了图7所示的其中一个网纹;
图9详细示出了图8所示的一对啮合槽;
图10详细示出了图8所示的一对啮合凸起;
图11示出了图9和图10中所示的啮合槽和啮合凸起处于啮合位置;
图12示出了根据本发明实施的焊接操作;
图13详细示出了图12所示的焊接操作;
图14详细示出了根据本发明所制造的扩张器的局部;
图15详细示出了根据本发明所制造的扩张器的局部;
图16示出了根据本发明制造的扩张器的局部;
图17是图16所示局部的放大视图;
图18是根据本发明制造的扩张器的一个纵向件的剖视图;
图19是根据本发明制造的扩张器的剖视图;
图20是根据本发明制造的扩张器的透视图;
图21是根据本发明制造的尚未扩张的扩张器的前剖视图;
图22是图21所示的扩张器在扩张后的前剖视图;
图23是一前剖视图,示出了通过在一管子上切割出网纹而制造的尚未扩张的扩张器;和
图24是图23所示扩张器在扩张后的前剖视图。
现参照示出了本发明的扩张器制造方法的图1,同时参照用于了解图1所示方法的图2A,2B,2C,3和4。
在根据本发明的扩张器制造方法中,扩张器的设计者首先要制备一张呈平面形式的所需扩张器网纹的图纸(步骤10)。
图2A,2B和2C以举例的方式示出了三种扩张器网纹设计。图2A所示的网纹有两类部分20和22。每个部分20都有两个相对的断续性网纹,每个部分22都有一组连接线24。可以将图2A所示的网纹加工成任何尺寸,一种最佳的尺寸是使各部分20在1和6mm宽之间,使各部分22的连接线24为1-6mm长。在这种尺寸范围内,不能用激光切割系统切割出图2A所示的网纹。
图2B所示的网纹与图2A所示的网纹类似,它也带有由两相对的断续性网纹构成的部分20。图2B所示的网纹也具有连接部分,标为30,它呈Z字形。
图2C所示的网纹没有连接部分,它却带有一系列交替的网纹,标为32和34。
图2A,2B和2C所示的网纹可选择地也可以带有一组小凸起38,它们用于形成扩张器,如下所述。
现在回到图1,在步骤12中,在一块平的金属片上切割出扩张器网纹。该金属可以是任何生物相容材料,例如不锈钢,或者一种镀有生物相容材料的材料。只要在商业上可行,可以以任何方式实施切割操作,例如蚀刻,或用一精细切割刀具切割,或用极细的激光切割。
如果是用蚀刻实施步骤12,那么该工艺就被设计来切透金属片。该工艺是已知的,但出于完整性目的,现将其简单描述如下。
将网纹图纸缩小并将其印在一透明薄膜上。因为希望完全切透金属片,故将图纸印在两张薄膜上,这两张薄膜在它们的边缘上在几个地方连接在一起。用一层光敏抗蚀剂覆盖金属片的两面,并将金属片置于两张透明的印刷后的薄膜之间。用光照射金属片的两面,使得受光照射的光敏抗蚀剂部分(它们都是网纹中的空隙,例如图2A中的空隙26)改变性质。
将金属片置于酸液中,腐蚀掉性质改变的这些光敏抗蚀剂部分。然后将金属片放在蚀刻溶液中,蚀刻掉其上没有除光敏抗蚀剂溶液(它除去了光敏抗蚀剂)所有材料,这样就使金属片具有所需的扩张器网纹。
在步骤14中,使金属网变形,使其长边缘(在图2A,2B和2C中标为28)相遇。图3示出了变形过程。对于圆筒形扩张器而言,变形过程就是卷拢过程,如图所示。
如果已经加工出凸起38,在金属网变形后,凸起38就伸到不与凸起38连接的边缘28之上。图5A对此作了说明。
在步骤16中,用任何适当的工艺,例如点焊,将边缘28连接在一起。如果加工有凸起38,就可以或是用焊接、粘结剂或是用钉状元件40(如图6所示)将凸起38连接在相对的边缘28上。图5B示出了凸起与相对边缘28之间的连接。由于一般将凸起38设计成延伸一个圈的宽度,所以基本上可以保持网纹形状。见图5B。
作为另一种选择,可以将边缘28拢在一起,并在适当的地方连接。
图4示出了通过步骤10-16制造的具有图2A所示网纹的扩张器31。应当注意这种扩张器具有通过将点连接而形成的连接点32。
最后,将扩张器31抛光,以除去未在切割工艺(步骤12)中适当除去的多余材料。可以用机械方法进行抛光,例如用外表面上有金刚砂的抛光棒在扩张器31内部进行摩擦。作为另一种选择,也可以采用电抛光装置。
图7示出了本发明的另一种实施例,其中如前所述在金属片121上蚀刻和切割有一组网纹120。图8是一放大视图,示出了图7所示网纹组120的其中一个网纹。
图9是一放大视图,示出了图8所示多个啮合槽128和129的其中一对127。图10是一放大视图,示出了图8所示多个啮合凸起131和132的其中一对130。在金属片121和每个网纹120上都设置有一组用于容纳链齿的定位孔122和122’,以便在生产的各阶段准确地移动金属片121和网纹120并保持它们准确地对准。每个网纹120都有一个第一长侧边123和一个第二长侧边124,一个第一短侧边125和一个第二短侧边126。第一长侧边123带有多个啮合槽128和129(图9中详细示出)的对127,127’和127”。每个啮合槽对127,127’和127”都有一第一啮合槽128和一第二啮合槽129。第二长侧边124带有多个啮合凸起(图10中详细示出)的对130,130’和130”。每个啮合凸起对130,130’和130”都带有一第一啮合凸起131和第二啮合凸起132。啮合凸起对130,130’和130”大致与啮合槽对127,127’和127”相对而置。
啮合槽128和129容纳并与啮合凸起131和132啮合,这样当网纹120变形和平的金属片卷曲时就可以保持扩张器对齐,这样第一长侧边123就与第二长侧边124相遇而形成一个管,如图19和20所示。
在每对127,127’和127”的啮合槽128和129之间有一个梁133。该梁可产生附加的稳定性,并在制造期间有利于对准,同时可附带地提高成品扩张器的焊接强度,如下所述。
在金属片被卷成一个管形扩张器并且啮合槽128和129容纳了啮合凸起131和132后,采用某种装置(未示出)保持对准并切断梁133,而留下两个大致相同的部分。可以用本领域技术人员已知的各种方法切断梁133,然而,在一最佳实施例中,采用激光。啮合槽128焊接在啮合凸起131上,啮合槽129焊接在啮合凸起132上,如图12和13所示。可以用本领域技术人员已知的各种方法完成这一过程,但在一推荐实施例中,可以采用一系列点焊。在一最佳实施例中,在每次焊接操作中采用约5个点焊,如图12和13所示。焊接产生的热融化了被切断的梁133的材料,并且这些材料被吸向设有梁133的啮合槽128或129并被吸入啮合槽和啮合凸起之间的焊接区,在这里这些附加的材料就变成它们的一部分并附加地提高了焊接强度。然后,就可以抛光该扩张器,如前所述。
图13是一放大视图,示出了图12所示的焊接区。在一推荐实施例中,焊接操作应偏离啮合槽和啮合凸起相互接触的点。在一最佳实施例中,焊接操作偏离约0.01mm。
图14详细示出了图8所示的网纹。中请人的发明也可以被描述为一个限定了一纵向孔80的可扩张的扩张器,该纵向孔具有一根纵向轴线或延伸线79和一周向轴线或延伸线105,包括一组柔性连接的网格50,每个柔性网格都有一第一纵向端部77和一第二纵向端部78。每个网格50还带有一个位于第一纵向端部77上的第一纵向顶点100和位于第二纵向端部78上的第二纵向顶点104。每个网格50还包括一个带有一纵向元件的第一构件51,该纵向件带有一第一端部52和第二端部53;一个带有一纵向件的第二构件54,该纵向件带有一第一端部55和一第二端部56;一个带有一纵向件的第三构件57,该纵向件带有一第一端部58和一第二端部59;和一个带有一纵向件的第四构件60,该纵向件带有一第一端部61和第二端部62。扩张器还包括一第一曲段63,它在第一构件51的第一端部52和第二构件54的第一端部55之间限定了一个角度64。限定了一第二角度66的第二曲段65位于第三构件57的第二端部59和第四构件60的第二端部62之间并且通常位于第一曲段63的对面。带有一第一端部68和一第二端部69的一个第一柔性补偿件或柔性连杆67位于第一构件51和第三构件57之间,第一柔性补偿件或柔性连杆67的第一端部68与第一构件51的第二端部53连接,第一柔性补偿件或柔性连杆67的第二端部69与第三构件57的第一端部58连接。第一端部68和第二端部69相互之间位于一个可改变的纵向距离70内。带有一第一端部72和一第二端部73的一个第二柔性补偿件71位于第二构件54和第四构件60之间。第二柔性补偿件或柔性连杆71的第一端部72与第二构件54的第二端部56连接,第二柔性补偿件或柔性连杆71的第二端部73与第四构件60的第一端部61连接,第一端部72和第二端部73相互之间位于一个可改变的纵向距离74内。在一最佳实施例中,第一和第二柔性补偿件或柔性连杆67和71是弧形的。当扩张器沿偏离孔80的纵向轴线79(如图20所示)的弯曲方向弯曲时,第一和第二柔性补偿件或柔性连杆67和71可以在不同程度上扩展和压缩。第一构件51,第二构件54,第三构件57,和第四构件60和第一曲段63和第二曲段65和第一柔性补偿件或柔性连杆67和第二柔性补偿件或柔性连杆71如此定位,即随着扩张器被扩张,第一柔性补偿件或柔性连杆67和第二柔性补偿件或柔性连杆71之间的距离增加,并且第一构件51,第二构件54,第三构件57和第四构件60的纵向元件缩短,同时第一曲段63和第二曲段65仍保持相互相对,第一柔性补偿件或柔性连杆67的端部68和69以及第二柔性补偿件或柔性连杆71的端部72和73张开,从而使第一柔性补偿件或柔性连杆67的第一端部68和第二端部69之间的可变纵向距离增大,并且使第二柔性补偿件或柔性连杆71的第一端部72和第二端部73之间的可变纵向距离增大。这样就补偿了第一构件51,第二构件54,第三构件57和第四构件60的纵向元件的缩短,并在扩张器扩张时基本上使扩张器的预先缩短可忽略不计。一旦扩张,第一柔性补偿件67和第二柔性补偿件71就对待处理的腔赋予支承。
图15示出了本发明最佳实施例的尺寸。使偏转点,即第一和第二曲段63和65以及第一和第二补偿件67和71,比第一、第二、第三和第四构件51、54、57和60宽,这样当扩张器扩张时偏转力就分布在一较宽的区域上。可以使偏转点在不同程度上宽于第一、第二、第三和第四构件,这样由于阻力减小首先会在较窄的区域上产生偏转。在一推荐实施例中,使第一和第二补偿件比第一、第二、第三和第四构件宽,使第一和第二曲段比第一和第二补偿件宽。使第一和第二曲段比第一和第二补偿件宽的优点之一是当扩张器扩张时扩张器可大致补偿预先缩短。在图5所示的实施例中,第一、第二、第三和第四构件51,54,57和60的宽度约为0.1mm。第一和第二曲段63和65的宽度约为0.14mm。第一和第二补偿件67和71上设有宽度约为0.12mm的加厚部分75和76。这样,在一最佳实施例中,第一和第二曲段的宽度和第一和第二补偿件的宽度分别比第一、第二、第三和第四构件的宽度约大40%和20%。
图16至20详细示出了根据本发明构成的扩张器。
图21至24示出了本发明的另一个优点。为清楚起见,图21至24所示的扩张器各部分的尺寸和位移程度都被故意地夸大了。
图21是沿根据本发明(图20所示)制造的尚未扩张的扩张器的A-A线所取的前剖视图。图21所示的未扩张的扩张器200在扩张前位于血管201的腔202内。如前所述,该扩张器是通过首先在一平的金属片上1切割出扩张器网纹,然后再将该金属片卷成管状而制造的。如图21所示,在卷曲后,未扩张的扩张器的的第一和第二柔性补偿件67和71往往会沿离开扩张器纵轴线或内腔的方向张开。这样,柔性补偿件67和71就限定了一个外径,该外径比扩张器其余部分所限定的外径大。图22示出了图21所示的扩张器在腔内及反抗血管内壁而扩张后的情况。如图22所示,一旦未扩张的扩张器朝血管壁扩张,血管壁就向第一和第二柔性补偿件67和71施加一机械力,这样补偿件就向扩张器的纵轴线或内腔移动,直到与扩张器的其余部分平齐。这样,当从断面上看时,扩张后的扩张器的内腔大致是圆形的,已扩张的扩张器上基本上没有什么部分会伸入已扩张之扩张器的内腔或朝其纵轴线伸出。
图23与图21类似,不同之处是采用制造扩张器的传统方法在管状件上切割出网纹。如图23所示,柔性补偿件并未离开未扩张之扩张器203的纵轴线而张开。一旦图23所示的扩张器朝血管201的壁扩张,柔性补偿件67’和71’往往会向内张开并伸入已扩张之扩张器203的内腔204。
图24所示的是图23所示的扩张器203在血管201的腔204内扩张之后的情形。柔性补偿件67’和71’未与扩张器的其余部分平齐并限定了一个比扩张器其余部分的直径小的直径。这些伸入扩张器内腔的部分在沿已扩张之扩张器的纵轴线流过的流体内造成涡流,并导致形成血块。
本领域技术人员应明白本发明并不受以上描述和图示所限。本发明的范围只由后面的权利要求书限定。
Claims (19)
1.一种制造扩张器的方法,包括的步骤为:
a)在一平的金属片上切割出一组扩张器网纹,每个所述网纹都有一第一长侧边和一第二长侧边,所述第一长侧边带有多个啮合槽对,所述第二长侧边带有多个啮合凸起对,所述多个啮合槽对和所述多个啮合凸起对大致相对而置,所述多个啮合槽对中的每一对都包括一第一啮合槽和一第二啮合槽,决定啮合槽的尺寸和位置使得当所述网纹变形并卷成管形时啮合槽可容纳啮合凸起并与之啮合,每对所述啮合槽都带有一个位于所述第一啮合槽和所述第二啮合槽之间的梁;
b)在所述金属片上设置一组对准孔;
c)使所述网纹变形为管形,而使所述啮合槽对与所述啮合凸起对啮合;
d)切断所述梁;
e)使每个所述啮合槽附着在与之啮合的啮合凸起上,以形成所述可扩张的扩张器。
2.如权利要求1所述的方法,其中采用激光实施步骤d)。
3.如权利要求1所述的方法,其中采用焊接实施步骤e)。
4.如权利要求3所述的方法,其中采用偏离所述啮合槽和所述啮合凸起相互接触的点的焊接操作实施步骤e)。
5.如权利要求4所述的方法,其中所述焊接操作偏离所述啮合槽和所述啮合凸起相互接触的点约0.01mm。
6.如权利要求3所述的方法,其中所述焊接是点焊。
7.如权利要求6所述的方法,其中采用一组点焊。
8.如权利要求7所述的方法,其中采用5个点焊。
9.如权利要求1所述的方法,其中采用粘结剂实施步骤e)。
10.如权利要求1所述的方法,其中采用钉状元件实施步骤e)。
11.一种可扩张的具有一纵向内腔的扩张器,包括:
一第一长侧边和一第二长侧边,所述第一长侧边带有多个啮合槽对,所述第二长侧边带有多个啮合凸起对,所述多个啮合槽对和所述多个啮合凸起对大致相对而置,决定啮合槽的尺寸和位置使啮合槽可容纳啮合凸起并与之啮合,所述啮合槽附着在所述啮合凸起上。
12.如权利要求11所述的扩张器,其中通过焊接将所述啮合槽附着在所述啮合凸起上。
13.如权利要求12所述的扩张器,其中所述焊接偏离所述啮合槽和所述啮合凸起相互接触的点。
14.如权利要求13所述的扩张器,其中所述焊接偏离所述啮合槽和所述啮合凸起相互接触的点约0.01mm。
15.如权利要求12所述的扩张器,其中所述焊接是点焊。
16.如权利要求15所述的扩张器,其中采用一组点焊。
17.如权利要求16所述的扩张器,其中采用5个点焊。
18.如权利要求11所述的扩张器,其中采用粘结剂将所述啮合槽附着在所述啮合凸起上。
19.如权利要求11所述的扩张器,其中采用钉状元件将所述啮合槽附着在所述啮合凸起上。
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