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CN100577127C - 流动调节植入件 - Google Patents

流动调节植入件 Download PDF

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CN100577127C
CN100577127C CN 200580020919 CN200580020919A CN100577127C CN 100577127 C CN100577127 C CN 100577127C CN 200580020919 CN200580020919 CN 200580020919 CN 200580020919 A CN200580020919 A CN 200580020919A CN 100577127 C CN100577127 C CN 100577127C
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implant
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CN 200580020919
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CN101076305A (zh )
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E·达汉
I·亚伦
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奥普通诺尔有限公司
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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
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • A61F9/00781Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment

Abstract

流动调节植入件设置有一个或多个用于允许流体流动的凹槽。一个或多个凹槽沿其长度可具有恒定的或变化的横断面。一个或多个凹槽在其内可具有生物可降解材料、吸收性材料和/或丝或缝线。弹性带或涂层可围绕上述植入件或一个或多个凹槽放置,以起到压力调节器的作用。上述植入件可具有侧面突出部,诸如侧面销,以便与组织接合。上述植入件可包括两个或多个部分,上述部分保持成彼此离开一定距离以允许流体在上述部分之间流动。

Description

流动调节ltA件技术领域本发明总体上涉及流动调节植入件,例如用于治疗青光眼咖艮科植入件。背景就美国专利No.5,868,697披露了用于调节流^t动的,和方法。上述^g 和方激U如有利于治疗青光眼,舰提微艮房水从眼睛中流出而斷氐眼内压力 (IOP)。在该专利中«的,和方法明确1©1参考结合入该说明书中。与在美国专利No.5,868,697中披露的體和方法相同,felt麟的體和 方法也用于调节流,动。在«露的,^^和方,1」如皿提供从眼睛流 出咖艮房水从而斷氐眼内压力(IOP),以便有利于治疗青光眼。发明内容在特定实施例中,本发明涉及具有一个或多个用于允许流体流动的凹槽的 舰的流动调节簡牛。在特定实施例中, 一个或多个凹槽沿其长度可具有恒定的横断面。在特定实施例中。一个或多个凹槽沿其长度可具有变化的横断面。例如, 一个或多个凹槽可为像漏斗的锥形。较宽的端,^A口端或出口端。在特定实施例中,一个或多个凹槽在其内可具有生物可,材料、吸收性 材料和/或丝或纖。在特定实施例中,弹性带或涂层可围绕上述植入件或一个或多个凹槽放 置,以起到压力调节器的作用。在特定实施例中,除了一个或多个凹槽以外,上述植入件可具有贯穿M:其的管通路。上述管通路在其内可具有生物可IM材料、吸收性材料,和/或 丝雜纖。在特定实施例中,,植入件可具有侧面突出部,诸如侧面销,以便与组 织接合。战突出部或销可有利于防止转动和/或稳固地将i^植入f條持在 组织中。在特定实施例中,上述植入件可包括两个或多个部分,上述部分彼此保持离^定距离以允许流体在上述部分之间流动。 附图说明图1是流动调节ISA件的第一实施例的透视亂 图2是图1所示流动调节纟IA件的替^t视图;图3是图1所示流动调节H/^牛的^f奂透视图;图4是图1所示流动调节HA件的透视亂在侧面凹槽中具有材料;图5是图1所示流动调节t!A件的透视亂在侧面凹槽中具有丝或纖;图6是图1所:示流动调节HA件的透视图,围^i^HA^牛具有流动调节带或涂层;图7是具有侧面凹槽的流动调节HA件的織实施例的透视图,在凹槽的出口端处具有孔;图8是具有侧面凹槽的流动调节IIA件的另一替换实施例的透视亂社述禾IA件出口端处的凸缘中具有孔;图9是具有侧面凹槽的流动调节HA件的謝奂实施例的透视亂在JJ^植入件出口端处具有替换的凸缘设计;图10是具有侧面凹槽的流动调节植入件的替换实施例的透视图,具有贯 穿M33LbMA件的管鹏;图11是图10的流动调节,IA件的透视亂在战管通路中具有丝纖线;图12是具有侧面销的流动调节植入件的替换实施例的透视亂图13是流动调节tIA件的替换实施例的透视图,包括两个部分,战部分彼此保持在一超巨离处以允许流#^±^部分之间流动;图14是流动调节植入件的替换实施例的透视图,包括两个部分,iil部分彼此保持在一定距离处以允许流Mi^部分之间流动,其中上述两个部分 可被推到一起或移动分开。 具体实施方式图1至3示出了流动调节植入件的第一实施例。所示的植入件为眼内植入 件10的形式。IIA件10包括杆11和凸缘(或碟離)12。战杆的横断面可采取任何合适的形状,例如正方形、矩形、椭圆形、圆形或不规则微。在该示出的实施例中,上述凸缘12的平面与上述杆11形成一个角度,战角度 大致相当于眼睛巩膜表面与植入件10插入的预期轴线之间的角度。上述凸缘12限制了插入的深度并使得该器件稳定。战凸缘12的偏斜有助于限制或防止 该器件的转动。在特定应用场合中,所希望的可能是取出上述器件,在该情况 下,Jd逸凸缘可用于该目的。禾IA件10具有入口端13和出口端14。凸缘12在IIA件10的出口端14 ^b^接到杆"。植入件10可具有一个或多个固位突出部15,以便ai入后保 持丰IA件10。 一个或多个固位突出部15可采取fij可合适的形式。^^f示的实施例中,杆11在HA件10的入口端13处具有修圆的糊13。 应该意识到Jd^端可采取其它合适的形式。例如,±^末端可以是31311斗切 表面形成的针^ra,成锐利的角度以便容易插Ai鹏球中。禾IA件10具有两个侧面的凹槽16入16B。在所示的实施例中,上述侧面 凹槽16AJ6B延伸范围是HA件10的从入口端13到出口端14的全长。, 侧面凹槽16入16B处于杆11的侧面上并且延伸经过凸缘12。根据本发明的植入件可借助结合Sk作为参考的美国专利No.5,868,697中 «的方法插入。MA件的插入并不限于这些方法。在特定情况下,皿望的 是以这样一种方式将上述器件植入,即,使得上述凸缘位于巩膜瓣片(sclera flap)即从巩膜切割的组织瓣片之下。在这种方法中,巩膜瓣片从巩膜小心地 切割形成。上述切割,为不切穿巩膜且一直切到前房。相反,J^切割只部 分地延伸切穿一距离,以产生可被移开的巩膜瓣片,从而暴露出用于插入上述 丰SA件的位置。当巩膜瓣片被提升开时,,植入4«入到预期的植入点,其 中凸缘位于巩膜瓣片之下。将该器件植入到巩膜瓣片之下可有助于流体的吸 收。舰有助于将战器件的固位。借助如图1至3所示的器件,在其工作战呈中,战凹槽16入16B形鹏 路,以便流体从HA件10的入口端13朝向出口端14流动。在眼内植入件的 情况下,目臓中的目瞎水倉辦沿战凹槽狀口端13朝向出口端14流动。,凹槽16AJ6B直接邻接植入件10植入其中的组织。这样,例如眼睛 的巩膜组织将围绕植入件。以这样方式,巩膜组织可以起到阀的作用,以控制 流体从眼睛流出。当前房内的压力低时,该组织紧靠植入件周围并位于凹槽中 以阻断或P蹄麟鹏凹槽的流动。当前房内的压力升高时,流体对该组织施加 压力以便使得沿凹槽的通路畅通,并且流体会沿在该植入器件与该组织之间的 凹槽流动。5眼房水。流体可由巩膜吸收或可例如在结膜之下流出。一个或多个凹槽可采取樹可适合的形式。例如, 一个或多个凹槽可成形为 漏斗形成,从一端到另一端逐渐变细。依据所需的应用场合,较宽端部可位于 出口端或入口端处。可以对一个或多个凹槽的尺寸、形状和/或横断面构型进行 鹏。应该意识到,除了流动调节作用之外,i^凹槽可起到限制或防止该器件 转动的额外益处。鹏该意识到,适于杆的非圆形横断面也会有助于限制或防 止该器件的转动。例如,具有拐角部的横断面,例如正方形、矩形或其它多边 概黄断面会有助于限制或防止转动。另外,沿不同方向具有不同尺寸的像椭圆 或矩形横断面的横断面会有助于限制或防止转动。即使杆具有圆形横断面形 状,凹槽也可有助于限制或防止转动。处于排液槽中的组织会有助于将该器件保持就位。图4是图i所示流动调节纟iA件的透视亂在侧面凹槽中具有材料n。在 该例子中,材料17可以是生物可,材料、吸收性材料或可用激光消融的材 料。这种材料可作用为开始时阻断或限制流动,并且随时间iim允许更多的流 动。例如,医生可在植入的一段时间之后或经过更长一段时间之后使得上述激 光可消融材料消融。生物可^^材料或吸收性材料可作用为开始植入时阻断流 动,并且随时间流逝消蚀或降解以允许更多的流动。在流动调节植入件中的这种材料用途的迸一步说明在美国专利No.6刀3,513和6,558,342中提供,其披 露内容结合feit作为参考。图5是图1所示流动调节^A件的透视图,在侧面凹槽中具有丝或缝线18。 丝纖线18可作用为开始时阻断或限制流动,并且随时间«允许更多的流 动。例如,医生可在植A^后的某段时间移除丝^^ 18,或可随更长时间段 之后一次移除一条丝或缝线18。应该意识到多于一条的丝,线18可«在 每一凹槽中。在流动调节植入件中的丝,线用途的进一步说明在美国专利Na 6,558,342中提供,其披露内容结合tt作为参考。图6是图1所示流动调节IIA件的透视亂围m^纟IA件具有流动调节 带或涂层19。带或涂层19可如图所示只延伸经过t!A件的一部錄度,或在 替换方式中,其可延伸入凹槽中。带或涂层19是弹性的并起到阀的作用以控制从眼睛流出的流体 流动。当前房内的压力低时,带或涂层19紧靠在植入件周围并位于凹槽中, 以阻断或P艮制流体沿凹槽的流动。当前房内的压力升高时,流体施加压力到带 或涂层19上以使得沿凹槽的鄉各畅通,并且流体会沿在t!A件的杆和带或涂 层19之间的凹槽流动。图7示出流动调节植入件的替换实施例。该流动调节植入件20类似于流 动调节植入件IO。流动调节植入件20具有杆21、凸缘22以及凹槽26A26B(凹 槽26B未示出)。在该实施例中,在凸缘中分别在凹槽26入26B的出口端处具 有孔27入27B。这些孔允许流体从HA件流出并远离aA件。图8示出流动调节HA件的另一实施例。该流动调节HA《牛30类似于上 述的流动调节植入件。流动调节植入件30具有杆31、凸缘32以及凹槽 36入36B。在该实施例中,在凸缘中具有孔38。由于具有该孔,可{^缝线来 将丰IA^^附到组织vh以将其固定就位。图9示出流动调节^A件40。该流动调节HA件40类似于战的流动调 节禾IA件。流动调节植入件40具有杆41、凸缘42以及凹槽46A46B。在该实 施例中,凸缘42具有不同的微,其有禾盱特定的卿场合。图10是具有侧面凹槽的流动调节HA件的替换实施例的透视图4IA件50 具有贯穿ffl3iJ:述IIA件的管ii^ 51。该管« 51提供适于流«动的额外 通路。,管M在其内可具有吸收性的、生物可,的、激光可消融的和/或 可移除的材料,以阻断或部分阻碍流ME动,并且随时间^^it许进一步流动。 图11示出图10的流动调节植入件,在i^管衝络51中具有丝,线58。图12是流动调节植入件60的替换实施例的透视亂具有侧面销68形式 的侧面突出部。在植入时,销68固定到鹏组织中并起到阻止该器件转动的 作用。销68也可有助于将该器件保持在巩膜中,提供围绕植入件的杆的巩膜 密封以防止不希望的泄漏。上述销也将该器件固定以防止该器件向结鹏加压 力和侵蚀结膜的可能性。,突出部或销可以是任何合适的材料,并且其是可移除的或可变的。例 如,战突出部或销可由吸收性的、生物可P繊的、激光可消融的禾IV或可移除 的材料制成。上述突出部或销68可沿?L在杆61中移动,因此可调节其从杆61 突出的长度。此外,可提供槽口或其它孔以允许突出部或销的定位调节。图13是流动调节t!A件的替换实施例的透视图。植入件70包括两销分 71,72,,部分保持成彼此离ff"魁巨离以允许流^th^部分之间流动。在 丰IA件70中,,两部分71,72借助两个圆柱体73入74B彼,接。f!A件可 形成为单件,或者i^部分可M:任何合适的手段例如焊接连接。上述两部分71,72可只«;—个圆柱体^131其«状的部分例如一个或多«体连接。可替换的,上述两部分可被成形为直接雜在一起但是在之间具有间隔。应该意 i鄉j^i^部分71,72之间的间隔74皿了适于流#^动的空间并允许更多的 流体接触鹏。图14示出包括两个部分81,82的流动调节植A^牛80,,两个部分一起形 成为单一的»1^的器件。如图14所示,似于所述的实施例,凸缘85在ltA 件的出口端鹏接,并且凸缘与第一和第二部分81,82形成一个角度。应该意识 至依战部分81,82之间的间隔84鄉了适于流條动的空间并允许更多的流 体織虫巩膜,类似于訓牛70。战两部分81,82可被推到一起鄉动分开, 其可控制间距并从而控制流体的流动。根据本发明构造的植入件可整个由任何合适的材料制造或由任何合适的材 料覆盖,诸如不糊、硅、金、镍钛诺、聚四氟乙烯、钽、PMMA (聚甲基丙 烯酸甲酯)或任何其它合适的金属材料,合材料或其它材料。旨器件可由 生物可隨材料制成。上述器件可M模制或任何其它的魏审腊方、絲制作。 上述器件可制作为单件或制作为组装在一起的斜虫件。上述丰IA件可用肝磷脂 或樹可其它誠的涂层涂敷。根据本发明的植入件可具有其它特征部分和/或借助施加装置植入和/或通 过其^"法tlA,例如Jd述的美国专利No.5,868,697; 6,203,513; 6,558,342中 麟的那些方法。如同本领域的那些普通技术人员会意识到的那样,,的各种实施例仅通 过例子的方式给出。在不脱离本发明的范围下可将各种变化、,和改变应用 于战实施例,本发明的范围由附加的权利要求限定。

Claims (4)

1.一种用于调节流体流动的植入件,所述植入件包括: (a)第一部分和第二部分,其中所述第一部分与所述第二部分间隔开,并且其中位于所述第一部分和所述第二部分之间的间隔用于使得流体流动以及 (b)凸缘,在植入件的出口端处连接,其中凸缘与第一和第二部分形成一个角度。
2. 权利要求1的tIA件,其特征在于,所述第一部分和所述第二部分 舰附加微雌接在一起。
3. 权利要求1 ,IA件,其特征在于,所述第一部分和所述第二部分 作为单件的綱IA件的一部分形鹏一起。
4. 权利要求1的丰IA件,其特征在于,第一部分和第二部分适用于被 推在一起,以及移动分开,以便控制第一部分和第二部分之间的间隔。
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