CN1285724A - 调节流动的植入物及其制造方法和投送装置 - Google Patents

调节流动的植入物及其制造方法和投送装置 Download PDF

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CN1285724A
CN1285724A CN98813114A CN98813114A CN1285724A CN 1285724 A CN1285724 A CN 1285724A CN 98813114 A CN98813114 A CN 98813114A CN 98813114 A CN98813114 A CN 98813114A CN 1285724 A CN1285724 A CN 1285724A
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I·亚龙
O·亚登
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Abstract

一种植入物,包括一个可容许液体流过的管。在管的通道内插入一个流动控制杆。环绕管的周边具有可选择地被永久或暂时堵塞的一个或多个孔以形成所需要的流动特性。一个用以安放植入物的投送装置可包括一个中心孔,孔中放有一个可回缩的线。当植入物连接在投送装置上时,该可回缩的线贯穿该植入物的管通道。投送装置上的一个钩可防止植入物从回缩线上滑下。植入物在眼内就位之后,固位线从植入物中缩回。随着固位线的缩回,植入物由钩上自由地脱离,容许抽出投送装置,将植入物留在其位置上。在一个制造植入物的方法中,使用了不同直径的两个管。小直径管贴合在大管的纵向孔内。在切割两根管时,小管形成植入物的管,而大管留下的部分形成固位突起和/或植入物的盘。

Description

调节流动的植入物及其制造方法和投送装置
发明领域
本发明总体涉及用于调节体内液体流动的医用植入物。本发明可适用于例如治疗青光眼的眼科植入物。本发明还涉及制造这种植入物的方法和植入这些植入物的投送装置。
发明背景
使用医用植入物调节人体内液体的流动是众所周知的和惯用的。
这种植入物的一种应用是治疗青光眼。青光眼是一种眼科疾病,其特征为眼睛的眼内压力(IOP)升高到不正常的程度。正常的眼睛是通过眼内房水的循环来维持适当的IOP的,房水是由睫状体所分泌,其穿过瞳孔进入眼球的前房,并由小梁网和巩膜静脉窦滤出眼球。在患青光眼的情况下,房水的排泄通道被堵塞,房水不能以适当的速度流出眼球,眼内压力升高,眼球变硬,视神经因作用在其纤维上的压力而萎缩并脱离视网膜。由于视网膜内神经节细胞的逐渐死亡,出现一种特有的视神经变性疾病,导致视野缺损,最后失明。疾病的发展阶段的特点在于还伴有明显的疼痛。
如果在疾病进程的早期开始青光眼的治疗可防止进一步的恶化并保留眼睛的大部分的功能。治疗青光眼的目的是将IOP降低到被认为对一个特定的眼睛来说安全的程度,而不是降低到导致眼睛机能失常或视网膜并发症的程度。
一种类型的青光眼治疗是滤过手术,它为房水提供了另一个由眼球前房流出并进入结膜下间隙的通道,从而降低了IOP。在全厚度的手术中,穿过巩膜缘所造成的一个瘘管直接将眼球的前房和结膜下的间隙连接起来。全厚度的手术可提供对IOP的持久的控制;但是,在术后的早期阶段房水过度地从眼球流失常导致压力过低。
在进行校正的滤过手术(小梁网切口术)中,穿过巩膜缘所造成的瘘管用一个覆盖部分厚度的缝合的巩膜舌瓣进行保护。该巩膜舌瓣对于房水从眼球的过度流失提供了附加的阻力,从而降低了术后早期阶段压力过低的风险。然而,与全厚度手术相比,小梁网切口术可产生较高的最终IOP并增加滤过手术后期失效的风险。
按照近期提出的一种方法,一个全厚度滤过瘘管可以用钬激光探头形成,其由外科手术所产生的疤痕最小。在进行眼球后部的麻醉后,在欲进行巩膜造口术的部位后面约12-15mm处做一个结膜切口(约1mm),随后激光探头通过结膜下的间隙前进到缘部。然后,施加多次激光脉冲直到形成全厚度的痿管。由于难于控制巩膜造口的大小,这种技术有时会造成早期压力过低。另外,早期和后期的虹膜下垂进入巩膜切口将导致瘘管的突然封闭并最终导致手术失败。再有,尽管其相对简单,但此项技术仍需使用眼球后的麻醉以避免使用激光所造成的疼痛。在靠近已经受损的视神经注射麻醉剂有时会导致进一步的视觉损害。这一方法以及其它类型的青光眼滤过手术的另一个缺点为痿管可能被疤痕所封闭。
为克服滤过手术存在的问题曾进行了各种尝试,例如,使用眼科植入装置。通常的眼科植入物利用排水管以保持眼球内所形成的用以降低IOP的开口的完整性。
通常的眼科植入物有一些缺点。例如,植入物为调节眼球内房水的流动通常使用一个阀瓣机构;这种阀瓣机构中的故障和/或失效可能导致房水从眼球过量流失并可能造成压力过低。常时间的使用植入物也往往导致阻塞,这种堵塞或是来自内部的组织,如虹膜被吸入进口,或是由于外部的细胞增生,如结疤。另外,通常的植入物插入手术复杂,昂贵且费时。
授予Donowitz等人的美国专利No.3,788,327展示了一种利用阀瓣机构调节眼球内房水流动的植入物的已有技术。如上所述,这种阀瓣机构中的故障和/或失效可能导致房水从眼球过量流失并可能造成压力过低。另外,美国专利No.3,788,327所示的植入物的入口和出口都容易遭到堵塞--入口被虹膜堵塞而出口被疤痕堵塞。最后,根据美国专利No.3,788,327的一个植入物的植入可能包括几个步骤,首先要提供一个通道以接受该植入物,和/或在植入物就位以后进行缝合,这将增加手术的时间和复杂性。
发明概述
本发明的目的是要提供一种改进的用于调节体内液体流动的植入物。本发明可用于例如眼内植入物,用以植入眼球以治疗青光眼。本发明的另一个目的是要提供一种制造此类植入物的方法和用以植入这种植入物的投送装置。
在根据本发明的一个改进的植入物的实施例中,提供了一个可植入眼球内的眼内植入物。该植入物包括一个管,该管具有一个进口端,一个出口端,和一个位于其间的管通道以使房水流出眼球,以及一个在管出口端连接于管上的盘。管通道具有一个足够小的横截面积以抑制房水流过管通道。一个控制线或杆插在管通道内以对流动提供进一步的控制。可以根据所需的流动特性选择控制杆的形状。在IOP低于一个阈值时可选择成阻止流动的形状。
设计成位于结膜下面的盘可具有一个外缘以形成一个储液槽,该槽具有比管通道的横截面积扩大了的横截面积。当房水流过管通道时,在结膜下形成一个房水的水泡,作为IOP的功能,使水泡和结膜的弹性有助于调节房水穿过管时的流动。
为防止植入物被堵塞,在管的进口端配置有一个倾斜的表面,在植入物被插入时使该倾斜的表面背离虹膜的方向。另外,沿管配置了一个或多个环周边的孔以使房水即使在轴向的进口被堵塞时也能流入管通道。该孔或这些孔可有选择地永久或暂时地被堵塞以提供所需的流动特性。
为防止出口端被堵塞,盘可带有一个如上所述的外缘,将结膜上举离开管通道的轴向出口以便使房水流出。为此目的在盘上也可配置一个或多个内部的立柱(也可采取内部凸缘的形式)。为进一步避免堵塞,将植入物安放在结膜下距离结膜的插入切口一定距离的地方,使切口愈合时伤疤组织不会在植入物轴向出口的区域内形成。
植入物的另外的一些特性可使植入变得更为方便。例如,植入物可以带有一个或多个固位突起(例如,齿,凸缘,或盘)。固位突起可以是刚性的,或是用弹性材料制成,从而在穿过巩膜时能够向内弯曲靠在管上。作为一种选择,固位突起可设计成在开始时相对扁平地靠在管上以便于穿过巩膜并防止将巩膜撕裂,同时带有一种机构在植入物已被植入眼球时能使固位突起向外伸出。例如,固位突起可由一个单独的扩张工具向外伸出或用形状记忆材料如PMMA或镍钛诺制成,在受到眼球内热的作用时向外伸出。一个或多个这样的固位突起足以将植入物可靠地锚固在眼球内而不需要缝合,这省时又省钱。
植入也可通过植入物上的在穿过巩膜时可透过角膜看到的一个或多个标识件而变得更为方便。例如,一个如上所述的环周边的孔可起到一个标识的作用;另外,标识可以是某些其它合适的可视机构,如管上的刻痕或彩色标识。标识的可视性使医生了解标识已通过巩膜,指示植入物已经就位。
植入物的安放可使用一种投送装置,该装置包括一个手柄和一个杆状器具,例如一个针或探头,用以携带植入物进行插入。投送装置具有一个用以插入植入物管通道内的头部和一个适当的固位机构以防止植入物在植入时从投送装置向上移动。固位机构还应做成能防止植入物在植入时发生转动以保证植入物的正确定向。投送装置还附带有适当的扩张工具,一个或多个突起一旦穿过所需组织时该扩张工具将植入物上的一个或多个固位突起向外伸出。
在根据本发明的投送装置的一个实施例中,杆状器具带有一个中心孔,其中设置有一根回缩线。在植入物连接在投送装置上时回缩线穿过植入物的管通道。投送装置上的一个钩防止植入物由线上滑下。在植入物就位于所需的植入部位以后,由植入物上抽出回缩线。随着回缩线的抽出,植入物即可由钩上自由地滑开,使投送装置能够被抽出,并将植入物放置就位。
在根据本发明的一个放置植入物的方法中,在结膜的一部分上切开一个小缝,小缝通常位于距欲植入部位一定距离的地方。因为植入物本身是很小的,小缝也会是很小的,例如约2mm或再小些。小缝的小尺寸及其距植入部位一定距离的位置(例如约10mm)将有助于防止巩膜造口部位的污染并减少感染的风险。
植入物穿过小缝,对准植入部位,并在植入部位处插入巩膜中。巩膜可以由如上所述的管进口端倾斜表面所形成的植入物管的针状头部所刺穿或是由携带植入物的投送装置上的一个针的头部所刺穿。因此,植入物可直接插入眼球而不需要任何单独的刺穿步骤,从而节约了成本和时间。
在根据本发明的用于制造眼内植入物的方法中,使用了两个直径不同的管子。较小的管能贴合在较大管的纵向孔的内侧。当管子被切割时,较小的管形成植入物的管而较大管的剩余部分形成植入物的固位突起和盘。
根据本发明的一个眼内植入物提供了全厚度瘘管的优点,同时避免了标准的小梁网切口术的限制。根据本发明的植入物是很小的且不需要外科手术即可植入。不需要手术室或住院治疗,从而降低了成本。植入是最小限度侵入的,且简单、快速、仅需局部麻醉。不需要眼球后的麻醉,从而避免了对视神经的医原性伤害。不需要进行虹膜切除术,因而维持了房水的流动,使水晶体的营养状况未受影响,降低了因操作所引起的白内障的可能性。
根据本发明的植入物除用于眼内植入物领域之外还可用于其它用途。例如,植入物可用于排除阴囊积水的液囊,调节阴囊积水的液囊和皮下阴囊之间的流动。本领域的技术人员可以理解,根据本发明的植入物的其它应用是可能的。
附图简述
图1为表示插入眼球的眼内植入物第一个实施例的示意横截面视图;
图2为图1所示眼内植入物放大的透视图;
图3为类似于图2的视图,其中切去了部分眼内植入物以表示其横截面视图;
图4为图1所示眼内植入物的盘部分的放大透视图;
图5到7表示在图1所示眼内植入物运作过程中结膜的作用,其中图5表示无水泡形成的运作阶段,图6表示有水泡形成,而图7表示水泡继续形成。
图8至图10表示一个投送装置和将图1所示的眼内植入物插入眼球的情况,其中图8表示在插入前的投送装置和植入物,图9表示投送装置和植入物正穿过结膜上的一个小缝进行放置,而图10表示插入后的植入物和已被抽出的投送装置;
图11表示第二个眼内植入物实施例的放大了的透视图,其中部分眼内植入物被切除以显示其横截面视图;
图12为图11中的眼内植入物的顶视图,显示植入物的盘部分;
图13表示一个投送装置和图11所示植入物插入眼球中的情况;
图14为图11所示眼内植入物的示意横截面视图,所示植入物已插入眼球;
图15和16表示眼内植入物的第三个实施例,其中图15表示附着固位板之前的植入物,图16表示附着固位板之后的植入物;
图17到图19表示根据本发明的一个实施例制造眼内植入物方法中的顺序的步骤,其中图17表示在制造过程的初始阶段所切割的外管,图18表示连接于内管的外管,而图19表示最后制成的眼内植入物;
图20表示根据本发明的一个眼内植入物,在其中的管通道中带有一个流动控制线或杆;
图21A到图21D表示流动控制杆的四种变形截面图;
图22表示一个带有螺纹流动控制杆的眼内植入物;
图23表示一个带有锥形流动控制杆的眼内植入物;
图24表示一个带有可调流动控制杆的眼内植入物;
图25表示一个带有可选择地进行阻塞的侧孔的眼内植入物;
图26表示一个带有柔性流动控制杆的眼内植入物;
图27表示一个带有受弹簧偏压的流动控制杆的眼内植入物;
图28表示一个根据本发明的投送装置实施例的末端和连接在投送装置上的一个植入物;以及
图29表示和图28相似的一个视图,其中投送装置的固位线从植入物中缩回。
发明详述
图1表示植入眼球10中的一个眼内植入物30。植入物30包括一个针状管32和一个盘34。盘34的平面与管32形成一个角度,该角度和巩膜12的表面与植入物30的插入轴线之间的角度相对应。植入物30在靠近角膜16的缘区14插入眼球10的巩膜12内,并伸入前房20内靠近虹膜22的地方。植入物30插入时应使盘34位于结膜18下方的巩膜12的表面上。植入物30可以放置在眼球筋膜(未示出)的上方或下方。本领域的普通技术人员应该理解,插入植入物30的正确位置并不局限于所示的部位,而可以是任何其它适合的位置,如在虹膜22的后方。
图2为图1所示植入物30的放大了的透视图,图3为植入物30被部分切除的一个相似视图。管32可以为改进的标准眼球后端的形式,具有一个进口端40、一个出口端50、和在其间延伸的管通道38,其中管通道38具有一个轴向进口41和一个轴向出口51。盘34连接在管32的出口端50上。整个植入物是很小的;例如管32的长度约2mm、宽度约0.5mm,盘34的直径约1mm、厚度小于0.1mm。
管通道38具有足够小的横截面积以限制房水通过管通道的流动。在一个实施例中,例如,圆柱形管通道38的直径约为300微米。通过使用管通道的特定的内部横截面积,避免了房水过度地从眼球流失。
当IOP高于一个阈值例如约5mmHg时,房水从眼球10的前房20通过轴向进口41和一个或多个周边孔42经管通道38排出,并进入结膜18下面的间隙内。周边各孔42可以采取任何适合的形式,例如,可以采取其总横截面积等于管通道38之横截面积的多个圆形孔口的形式。周边孔42可防止管通道38在其进口端被堵塞,因为即使虹膜22阻塞了轴向进口41,房水仍能穿过周边孔42。在轴向进口41被阻塞的情况下,周边孔42还可起到在管通道38内产生一个回压的作用以将轴向进口41的堵塞物清除。周边孔42还可用于保证植入物30插入适当深度,因为在插入过程中在穿过巩膜之后可以看到上部的孔,因此可用作一个标识。为起到这一作用,可以使用任何其它适合的标识(例如一个刻痕或着色标识)。
管32的进口端40具有一个由斜面36形成的针状头部,形成一个尖锐的角度以便于插入眼球。斜面36增加了轴向进口41的面积,扩大了通向管通道38的入口。斜面36设计成背离虹膜22的方向,以减少轴向进口41被堵塞的可能性。由于盘34设计成抵靠在巩膜14上而斜面36设计成背离虹膜22,所以斜面36所在的平面和盘34所在的平面形成相反的角度。
管32可以带有一个或多个与其形成整体的形状为一个或多个齿52的固位突起,以便在植入物30插入后将其保持在眼球10内。另外,固位齿52可做成连接(例如焊接或钎接)在管32上的单独部分。固位齿52可以是刚性的,或者是柔性的,在刺穿巩膜时它朝向管32弯曲,并在穿过巩膜以后向外弹出到其初始的形状。或者,固位齿52可设计成当其位于眼球10内时由一个单独的扩张工具(例如,一个气囊)使其产生塑性变形,或者固位齿52由形状记忆材料如PMMA或镍钛诺制成,在凉爽时齿扁平地贴在管上而在受到眼球10的热量时膨胀到其最终的形状。
盘34放大地示于图4,它包括一个底盘44,一个外缘46,和多个内部立柱48。立柱48之间的区域构成房水横向流动的通道56。底盘44和外缘46确定了一个储槽54,在运作中房水自管通道38的轴向出口51流出并进入储槽54。通道56可看作储槽54的一部分。储槽54与管通道38的横截面积相比扩大了的横截面积为结膜18吸收房水提供了较大的区域,同时和结膜18的弹性一起还起到调节房水流过植入物30的作用,如同IOP的作用一样。
图5到7表示植入物30运作的过程中结膜18的作用,可以看出由管通道流出的房水在结膜下面形成一个“水泡”24。本领域的技术人员可以理解,较高的IOP导致较高的通过植入物30的流速,同时房水以较大的力作用在结膜18上。
盘34的外缘46除了确定储槽54之外,还起到另外的作用,即,将结膜18上举离开轴向出口51以防止管通道38被堵塞。内部立柱48也可用于这一目的。
盘34的形状可以是但不局限于一个椭圆形,本领域的技术人员可以理解,盘可以具有能使植入物贴合在结膜18下面并能调节IOP的任何形状。盘34的大小和/或形状和/或盘34与管32之间的角度都可改变以采用适合不同人眼睛的不同植入物。
图8到10表示一个投送装置60和将眼内植入物30插入眼球的方法。首先将植入物30连接在投送装置60上,该装置具有一个手柄62和一个诸如针或探头的杆状器具64。杆状器具64具有一个用以穿过植入物30之管通道的头部70和一个固位机构,用以防止植入物在安放过程中从投送装置向上移动,该机构例如可取为支撑面68的形式,支撑面所具有的角度通常与盘34的角度相对应。这种形状还可防止植入物30在投送装置60上转动,从而保证了植入物在眼球中的正确定向。固位机构还可包括一个或多个在外缘内侧延伸的突起和/或在盘34上各内部立柱之间延伸的突起。在另一个实施例中,固位机构可以是杆状器具的头部,其与植入物管通道的内侧形成摩擦啮合,从而防止在植入过程中植入物从投送装置向上移动。
图9示出一个投送装置60,其中的杆状器具为一个针65。在所述的实施例中,投送装置60和标准的医用注射器相似,具有一个外壳和一个带有孔径67的针65。针65的前端69制成一个支撑面,其角度通常和盘34的角度相对应。针65的孔径67的头部为一个塞子71的形状,塞子构形成具有和管通道38相应的横截面形状。植入物30放置在塞子71上,其中塞子71的端部伸入管通道38,而针65的前端69紧靠在盘34上。塞子71在植入过程中阻塞了管通道38。
为将植入物30插入眼球10,在结膜18的一部分上切开一个微小的小缝26,小缝通常位于与结膜18覆盖拟植入部位的部分28相距一定距离的地方。相距植入部位一定距离的小缝(例如为1-2mm的小缝)距离植入部位约为5-15mm,这减少了房水通过小缝流出结膜的可能性,减少了感染的可能性,减少了在植入物轴向出口上结疤的可能性,同时便于封闭和愈合。
利用投送装置60将植入物30穿过小缝26到达结膜18下面的巩膜14中的植入部位。图9仅为示意地示出植入物的推进状况;可以理解,在实践中植入物由小缝指向植入部位大体是沿着巩膜的表面进行的,使得植入物的纵轴线大体平行于巩膜的表面。在到达植入部位时,植入物被倾斜以刺入巩膜。由植入物30的倾斜面36所形成的针状头部的尖锐角度确保植入物30能容易地进入巩膜14。针状头部穿过巩膜14进入眼球10的前房20,而盘34被上推靠在巩膜14上。
在植入物30就位时,如图10所示,固位齿(或一些固位齿)52将植入物30锚固在眼球10内并防止植入物30在抽出投送装置60时滑出。固位齿52还可在植入物30就位后防止其滑出。
本领域的技术人员可以理解,插入植入物并不局限于上述的方法,可以使用在该领域内所周知的各种方法中的任何一个。投送装置可包括一个“内”或“外”针。一种业内周知的直的或绞合的导向线可用以将投送装置引导到其精确的位置。为便于插入,可使投送装置进行振动,或进行润滑,可将诸如医用膏剂或凝胶涂抹在投送装置上。另外,在植入物被植入以后,一种合适的纤维化抑制混合物(例如,5FU,mitomycin)可施加于植入部位。
图11表示眼内植入物130的另一个实施例。植入物130包括一个连接着一个椭圆形盘134的管132。管132具有一个进口端140,一个出口端150,和一个管通道138,其中的管通道138具有一个轴向进口141,一个轴向出口151,和周边孔142,以便由眼球10的前房20将房水排出到结膜18下面的间隙内。
管132的远端152为一个不完全的锥形。形式为固位凸缘158并大致和盘134平行的多个固位突起形成在管132的外周边上,它们起着锚固件的作用,以将植入物130保持在眼球内。
如图12中放大的视图所示,盘134包括一个椭圆形底盘144,一个外缘146,和一个弯曲成内缘148形式的内部立柱,在其间构成了一个储槽154。多个“U”状通道156在内缘148中形成以便房水由轴向出口151流入储槽154。外缘146和内缘148可防止结膜18堵塞轴向出口151。
如图12所示,盘134的形状为椭圆形。盘134的长轴线大约两倍于管132的直径,并相对于管132是偏心移位的。盘134的椭圆形的形状和布局使植入物130具有宽阔的锚固区并使出口排泄区在椭圆形的长轴线上最大化。椭圆形的短轴线使植入物130得以适应结膜18下面的狭窄的间隙。
图13表示一个投送装置160和将眼内植入物130插入眼球的一种方法。植入物130可滑动地固定在投送装置160的一个针164上,和标准的医用注射器相似,针164连接在一个外壳162上。穿过植入物130的针164的头部174为一个锐角,于是头部174大体和植入物130的下部的角度是一致的。
投送装置160的前面形成一个支撑面,其角度和盘134的角度相匹配,并且还包括一个凹槽172以便在植入时将植入物130保持就位。投送装置160的形状和倾斜的盘134表面防止植入物130在植入时产生转动。
图13所示的投送装置160的应用方式和参照图8到10所述的方式相似。然而,在该实施例中,针头部174的锐角可刺穿巩膜。植入物装置130的成角度的进口端随着针头部174穿过巩膜14,进入眼球的前房20。如图14所示,固位凸缘158将植入物130锚固就位并在抽出投送装置160时防止植入物130滑出。固位凸缘158的锚固还可防止植入物130在就位后滑出。
图15和16表示眼内植入物的第三个实施例。该实施例和图1至图10所示的相似,只是为进行锚固,用固位板252形式的单独连接的固位突起代替了固位齿52。固位板插入植入物230管上的槽253内并可用适当的装置紧固,例如在植入物230由不锈钢制成的情况下可使用焊接。
根据本发明制造的植入物可完全由诸如不锈钢,硅,黄金,nitinol,特氟隆,钽,PMMA,或任何其它适合的塑料或其它材料制成或由这些材料所覆盖。植入物还可涂覆有肝磷脂或任何其它适合的生物活性化合物。
根据本发明制造一个植入物可按照以下工序进行。管可由一个标准的不锈钢皮下注射针的头部形成。利用一个EDM(放电加工)机械在针头部的近端钻出构成周边孔的小孔。在距头部与管所需长度相应的一定距离的地方,以和盘的所需角度相应的适当角度切割该针。随后在针的侧面切口以形成一个突起,该突起以后将向外弯曲形成齿。
盘可按照以下工序由一个不锈钢片化学蚀刻而成。由一个计算机辅助设计(CAD)系统画出盘的图形并用激光绘图仪标绘在一个透明薄膜上。标绘在盘的上面和下面进行。上面的标绘例如包括外缘和内部立柱;下面的标绘例如包括盘的底板。
在不锈钢片的两面粘附上一层光敏抗蚀剂。然后光敏抗蚀剂透过在其上进行标绘的薄膜暴露于UV(紫外线)光。板上由于标绘而被阻挡的区域未被曝光。暴露于UV光的光敏抗蚀剂随即以化学方式去除。
利用蚀刻化学药品对不锈钢片进行蚀刻,化学药品腐蚀掉不锈钢片上已去除光敏抗蚀剂的部分。蚀刻是受时间控制的,从而化学药品腐蚀掉的材料只达到预定的深度。
通过对包括外缘和立柱的上侧面进行标绘,不锈钢片上表面的化学药品腐蚀掉盘外侧面上的位于储槽内(包括各立柱之间的)和拟安放管的盘中心的材料。由于蚀刻是受时间控制的,作用在不锈钢片表面上的化学药品只腐蚀掉钢片厚度的一部分。通过对包括盘底板的下侧面进行标绘,不锈钢片下表面上的化学药品腐蚀掉盘外侧面的材料和拟安放管的盘中心的材料。作用在不锈钢片底面上的化学药品只腐蚀掉钢片厚度的一部分。由于来自上面和底面的化学作用,盘外侧的材料和拟安放管的盘中心的材料通过对钢片整个厚度的蚀刻过程被全部腐蚀掉。在蚀刻过程中盘外侧可留下一个小的伸出的部分以防止盘从钢片上脱开。
根据本发明制造植入物的另一种方法示于图17到19。图17表示该工艺过程的初始步骤,其中一个具有纵向孔的外管74被切割如图所示的形状。外管74可具有例如约1mm的外径和约400微米的内径(即,其纵向孔的直径)。图中外管74被切成两块76和78;但是,本领域的技术人员应该理解76和78两块不必完全脱开。例如,管74底部的一半在两块之间可保持接触,在两块76和78之间留下一个半圆筒形的连接片。
在该过程的下一个步骤中,如图18所示,一个较小的内管90放置在外管74的保留部分的纵向孔内。内管90的外径大体和外管74的内径相应。例如,内管可以具有约400微米的外径。内管也具有一个纵向孔,该纵向孔可具有例如约200微米的直径。当内管90安放于外管74内时,两个管可紧固在一起,例如在参考数字86和88所标示的区域将管焊接在一起。
在两个管连接在一起以后,再进行切割以形成图19所示的植入物。该步骤包括在植入物的出口端沿一个成一定角度的平面同时切割外管和内管,以形成盘84的上表面并将内管90的不切除就会伸出到盘84上表面之外的不需要的部分切除。在最后这样的切除之后,内管90留下的部分形成植入物的轴。在最后这样的切除之后,外管74所留下的部分形成了固位突起82和盘84。
本领域的普通技术人员可以理解,该制造过程的各种变形和其它的制造方法都是可能的。例如,一个塑料制成的植入物可用适当的模压作业进行制造。
如果需要可采用不同的机构,以便提供植入物的不同流动特性。可能需要针对不同的患者使用具有不同流动特性的植入物和/或对于一个特殊的患者需要有一种在植入后可改变其流动特性的植入物。
图20到25表示有助于控制液体如房水流过根据本发明植入物100的各种机构。在图20中,植入物100在管通道102中带有一个控制流动的线或杆92A。流动控制杆92A可以点焊在管通道102内侧的一个侧面上。
流动控制杆92A的功能为减少在植入物100之管通道102内侧的特定长度内液体所流过的横截面积。由于流动为其所经过的腔的横截面和长度的函数,流动控制杆92A的介入起到了增加流动阻抗的作用。例如,在一个眼内植入物中这有助于减少压力过低的风险。
流动控制杆92A的直径可根据所需的流动特性进行选择。例如,直径为200微米的植入物内部管通道所安装的流动控制杆92A的直径可在175微米和195微米之间。一个较大直径的流动控制杆92A可提供对流动的更大的阻抗。
可同样地对流动控制杆的长度和横截面形状进行选择以达到所需的流动特性的目的。图21A到21D表示流动控制杆四种可能的横截面形状。流动控制杆92A具有一个圆形的横截面。流动控制杆92B和流动控制杆92A相似但带有附加的槽94B。流动控制杆92C具有一个扁平的表面96C。流动控制杆92D具有一个纵向孔98D。
图22和23表示流动控制杆可能的进一步修改以改变流动特性。如图22所示,流动控制杆92E可带有外部的螺旋形槽99E,使其具有螺纹的外形。如果流动控制杆92E的直径较大,则大部分或所有的流动都通过螺旋形槽99E,该实施例提供了一个较长的液体流动途径并因而提供了较大的流动阻抗。另外或者作为另一种选择,如图23所示,流动控制杆92F的形状可以是削尖的或部分锥形的。该实施例对朝向植入物出口端的流动形成较小的阻抗。本领域的技术人员应该理解,对于流动控制杆形状和尺寸的许多其它变形都是可能的。
利用一个可调的流动控制杆使植入物的流动特性同样也是可调的。因此,例如,流动控制杆仅通过摩擦配合安装在管通道内,从而其在管通道内的位置是可调的。如图24所示意说明的,流动控制杆92的纵向位置可进行调节以便为液体从进口侧孔104到流动控制杆92之末端的流动提供一个可以或长或短的距离d。液体运行的一个较长的距离d提供了较高的流动阻抗。利用如图21B和21C所示的非圆横截面的流动控制杆调节流动的另一种途径为在管通道内转动控制杆。这种转动改变了杆相对于侧孔104的方位,使植入物产生不同的流动特性。
植入物的流动特性可在植入前根据患者的需要进行调节,或者,如果需要,植入物可以制成在植入物被植入以后使通过植入物的流动特性可以改变。在植入物被植入以后,流动控制杆92可向前推向植入物的进口端,例如使用带有一条线的工具。这将减少液体由进口侧孔104到流动控制杆92端部所需运行的距离d,于是减少了液体流经植入物的阻抗。或者,一个带有非圆形横截面的杆可以在植入以后进行转动。
另一种产生不同流动特性的途径是侧孔104具有不同的位置或形状。因此,不同型号的植入物所具有的侧孔可处在不同的位置和/或具有不同的形状。另外,一个植入物本身的侧孔是可以改变的,例如通过对一个或多个侧孔进行临时地封堵来实现。图25表示一个带有封堵的侧孔104的植入物。封堵可以是永久的或暂时的。暂时的封堵可例如利用工具或激光探头使用一种可吸收的材料或使用一种在植入以后可以除去的材料。这样,流动的阻抗在植入后可以降低。
植入物可以另外或作为另一种选择设计成根据液体压力的作用产生不同的流动特性。流动控制杆或线本身是可弯曲的或可移动的并设计成随液体压力而弯曲或移动。例如,如图26所示,流动控制杆92G在其一端122固定在植入物100的前端而杆92G的另一端124未被连接并可自由弯曲。在植入前,杆92G基本上沿平行于管通道的轴线延伸。在植入时,液体通过侧孔104传来的压力使杆92G弯曲,如虚线所示。这样,当植入物进口端的液体压力升高时,杆92G弯曲而容许增大流动。
另外的相关实施例示于图27。在该实施例中,管通道102A为锥形而流动控制杆92H在管通道102A内受到一个弹簧126的偏压。所示流动控制杆92H为锥形,应该理解,其它形状也是可能的。图中表示弹簧126在靠近管通道102A的出口端处被支撑抵靠在凸缘128上,应该理解,它也可连接在杆92H的相对侧靠近管通道102A进口端的地方。当进口端的液体压力增大时,作用在杆92H上的力使弹簧126压缩(或者,如果弹簧位于杆的相对侧上,杆上的力将使弹簧拉长)。杆92H因而沿纵向朝植入物的出口端移动到管通道102A横截面较大的位置。因此,使液体流过的面积增大,容许有更大的流动。熟悉此项技术的人应该理解,随着植入物进口端压力的增大,杆移动或弯曲从而增大流动的其它变形是可能的。
图28表示根据本发明的一个投送装置110的另一个实施例的端部部分。投送装置110具有一个手柄(未示出)和一个杆状器具112。其中,杆状器具112带有中心孔114,孔中放置有可回缩的线116。设置可回缩的线116,用于当植入物100连接在投送装置上时穿过植入物100的管通道102。投送装置110带有一个包括一支撑面118的固位机构,支撑面所具有的角度和植入物100的盘106的角度相应,用以防止植入物100在植入时从投送装置向上移动,固位机构还包括一个钩120用以防止植入物100从线116上脱落。
为进行植入,将植入物100放在线116上,使线116伸入管通道102并使支撑面118相对接地紧靠着盘106,使钩120环绕着相对侧夹持住盘106。图26表示在这一情况下的投送装置110的端部,其中固位线116处在其向前的位置上。
在植入物就位后,固位线116从植入物100中抽出。图27表示固位线被缩回时投送装置110的端部。随着固位线被缩回,植入物即可从钩上自由地滑开,容许抽出投送装置110,将植入物留在其位置上。
熟悉此项技术的普通人员也应理解,上述的关于植入物、制造方法、投送装置、和植入方法的各种实施例仅是作为例子给出的。对于所述的实施例可进行各种改变、修改和变形而不脱离由所附权利要求所限定的本发明的范围。

Claims (25)

1.一种用于制造植入物的方法,包括以下步骤:
选择一个带有一纵向孔的第一个管和一个带有一纵向孔的第二个管,该第二个管的尺寸可紧密地贴合于第一个管纵向孔的内侧;
将第二个管放置在外管的纵向孔内;
切割所述第一个管和第二个管以形成植入物。
2.根据权利要求1所述的制造植入物的方法,其特征在于至少第一个管的某些切割是在将第二个管放入第一个管的纵向孔内之前进行的。
3.根据权利要求1所述的制造植入物的方法,其特征在于至少第一个管的某些切割是在将第二个管放入第一个管的纵向孔内之后进行的。
4.根据权利要求3所述的制造植入物的方法,其特征在于切割包括在植入物的出口端沿一个成角度的平面同时切割外管和内管。
5.根据权利要求1所述的制造植入物的方法,还包括在将第二个管放入第一个管的纵向孔内之后将其焊接在第一个管上的步骤。
6.根据权利要求1所述的制造植入物的方法,其特征在于在完成切割之后内管所留下的部分形成植入物的轴,而在完成切割之后外管所留下的部分形成植入物的一个固位突起和一个盘。
7.一种用于调节流体流动的植入物,包括:
一个管,它包括一个进口端、一个出口端、和在进口端和出口端之间延伸的管通道,用以使液体流过管通道;
其中植入物具有一个位于管通道内的流动控制杆。
8.根据权利要求7所述的植入物,其特征在于流动控制杆具有一个圆形的横截面。
9.根据权利要求7所述的植入物,其特征在于流动控制杆具有一个非圆形的横截面。
10.根据权利要求7所述的植入物,其特征在于流动控制杆在其外表面上具有一个外部凹槽。
11.根据权利要求10所述的植入物,其特征在于外部凹槽为螺旋形。
12.根据权利要求7所述的植入物,其特征在于流动控制杆为锥形的。
13.根据权利要求7所述的植入物,其特征在于流动控制杆在管通道中的位置或角方位之一是可调的。
14.根据权利要求7所述的植入物,其特征在于流动控制杆在管通道内是可弯曲的以根据流体的压力调节流动。
15.根据权利要求7所述的植入物,其特征在于流动控制杆在管通道内是可移动的以根据流体的压力对流动进行调节。
16.根据权利要求15所述的植入物,其特征在于流动控制杆在管通道内被一个弹簧所偏压。
17.一种用于调节流体流动的植入物,包括:
一个管,它包括一个进口端、一个出口端、和在进口端和出口端之间延伸的管通道,用以使液体流过管通道;
其中管具有至少一个通向管通道内的周边孔,周边孔中的一个或多个被堵塞。
18.根据权利要求17所述的植入物,其特征在于对周边孔中至少一个的封堵是暂时的。
19.根据权利要求18所述的植入物,其特征在于暂时的封堵是由孔内随后可除去的材料形成的。
20.根据权利要求19所述的植入物,其特征在于暂时的封堵是由位于孔内的一种可吸收的材料形成的。
21.根据权利要求19所述的植入物,其特征在于暂时的封堵是由位于孔内的一种材料形成的,这种材料随后可用工具或激光二者中的一种除去。
22.根据权利要求17所述的植入物,包括至少两个通向管通道内的周边孔,其中周边孔中的至少两个位于距植入物进口端不同距离的地方,并且周边孔可以是堵塞的或敞开的以提供具有不同流动特性的植入物。
23.一种用于安放植入物的投送装置,该投送装置包括:
一个手柄;
一个带孔的杆状器具;
一个位于杆状器具孔内的可回缩的线;和
一个固位机构,包括一个用以防止植入物在植入时从投送装置向上移动的支撑面和一个用以防止在植入时植入物从线上脱落的钩。
24.根据权利要求23所述的投送装置,其特征在于钩可以防止植入物沿平行于线的方向产生移动但容许垂直于线的方向上产生移动,从而在该线从植入物管通道回缩时容许植入物从钩上滑脱掉以将植入物从投送装置上分离。
25.根据权利要求23所述的投送装置,其特征在于支撑面所形成的角度大体和植入物的盘的角度相应。
CN98813114A 1997-11-20 1998-11-18 调节流动的植入物及其制造方法和投送装置 Pending CN1285724A (zh)

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