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CN101732125B - 流动调节植入件 - Google Patents

流动调节植入件 Download PDF

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CN101732125B
CN101732125B CN 200910222824 CN200910222824A CN101732125B CN 101732125 B CN101732125 B CN 101732125B CN 200910222824 CN200910222824 CN 200910222824 CN 200910222824 A CN200910222824 A CN 200910222824A CN 101732125 B CN101732125 B CN 101732125B
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implant
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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

流动调节植入件

[0001] 本申请是2005年6月16日提交的、名称为“流动调节植入件”、申请号为 200580020919. 6的中国专利申请的分案申请。

技术领域

[0002] 本发明总体上涉及流动调节植入件,例如用于治疗青光眼的眼科植入件。 背景技术

[0003] 美国专利No. 5,868,697披露了用于调节流体流动的装置和方法。上述装置和方法例如有利于治疗青光眼,通过提供眼房水从眼睛中流出而降低眼内压力(IOP)。在该专利中披露的装置和方法明确通过参考结合入该说明书中。

[0004] 与在美国专利No. 5,868,697中披露的装置和方法相同,在此披露的装置和方法也用于调节流体流动。在此披露的上述装置和方法例如通过提供从眼睛流出的眼房水从而降低眼内压力(IOP),以便有利于治疗青光眼。

发明内容

[0005] 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改进的流动调节植入件。

[0006] 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。

[0007] 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。较宽的端部可在入口端或出口端。

[0008] 在特定实施例中,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。

[0009] 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。

[0010] 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通过其的管通路。上述管通路在其内可具有生物可降解材料、吸收性材料,和/或丝或缝线。

[0011] 在特定实施例中,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。 上述突出部或销可有利于防止转动和/或稳固地将上述植入件保持在组织中。

[0012] 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开一定距离以允许流体在上述部分之间流动。

附图说明

[0013] 图1是流动调节植入件的第一实施例的透视图;

[0014] 图2是图1所示流动调节植入件的替换透视图;

[0015] 图3是图1所示流动调节植入件的替换透视图;

[0016] 图4是图1所示流动调节植入件的透视图,在侧面凹槽中具有材料;[0017] 图5是图1所示流动调节植入件的透视图,在侧面凹槽中具有丝或缝线;

[0018] 图6是图1所示流动调节植入件的透视图,围绕上述植入件具有流动调节带或涂层;

[0019] 图7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,在凹槽的出口端处具有孔;

[0020] 图8是具有侧面凹槽的流动调节植入件的另一替换实施例的透视图,在上述植入件出口端处的凸缘中具有孔;

[0021] 图9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,在上述植入件出口端处具有替换的凸缘设计;

[0022] 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,具有贯穿通过上述植入件的管通路;

[0023] 图11是图10的流动调节植入件的透视图,在上述管通路中具有丝或缝线;

[0024] 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图;

[0025] 图13是流动调节植入件的替换实施例的透视图,包括两个部分,上述部分彼此保持在一定距离处以允许流体在上述部分之间流动;

[0026] 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,上述部分彼此保持在一定距离处以允许流体在上述部分之间流动,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

[0027] 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。植入件10包括杆11和凸缘(或碟或盘)12。上述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、圆形或不规则形状。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,上述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。上述凸缘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,上述凸缘可用于该目的。

[0028] 植入件10具有入口端13和出口端14。凸缘12在植入件10的出口端14处连接到杆11。植入件10可具有一个或多个固位突出部15,以便在插入后保持植入件10。一个或多个固位突出部15可采取任何合适的形式。

[0029] 在所示的实施例中,杆11在植入件10的入口端13处具有修圆的末端13。应该意识到上述末端可采取其它合适的形式。例如,上述末端可以是通过斜切表面形成的针状末端,成锐利的角度以便容易插入到眼球中。

[0030] 植入件10具有两个侧面的凹槽16A,16B。在所示的实施例中,上述侧面凹槽16A, 16B延伸范围是植入件10的从入口端13到出口端14的全长。上述侧面凹槽16A,16B处于杆11的侧面上并且延伸经过凸缘12。

[0031] 根据本发明的植入件可借助结合在此作为参考的美国专利No. 5,868,697中披露的方法插入。植入件的插入并不限于这些方法。在特定情况下,所希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。上述切割优选为不切穿巩膜且一直切到前房。相反,上述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植入件的位置。当巩膜瓣片被提升开时,上述植入件插入到预期的植入点,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。 这还有助于将上述器件的固位。

[0032] 借助如图1至3所示的器件,在其工作过程中,上述凹槽16A,16B形成通路,以便流体从植入件10的入口端13朝向出口端14流动。在眼内植入件的情况下,眼睛中的眼房水能够沿上述凹槽从入口端13朝向出口端14流动。

[0033] 上述凹槽16A,16B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限制流体沿凹槽的流动。 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。

[0034] 由于具有凹槽,从前房流出的眼房水允许直接接触巩膜组织,其允许由巩膜直接吸收眼房水。流体可由巩膜吸收或可例如在结膜之下流出。

[0035] 一个或多个凹槽可采取任何适合的形式。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/或横断面构型进行改型。

[0036] 应该意识到,除了流动调节作用之外,上述凹槽可起到限制或防止该器件转动的额外益处。还应该意识到,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、矩形或其它多边形横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。

[0037] 图4是图1所示流动调节植入件的透视图,在侧面凹槽中具有材料17。在该例子中,材料17可以是生物可降解材料、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,并且随时间流逝允许更多的流动。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。生物可降解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进一步说明在美国专利No. 6,203,513和6,558,342中提供,其披露内容结合在此作为参考。

[0038] 图5是图1所示流动调节植入件的透视图,在侧面凹槽中具有丝或缝线18。丝或缝线18可作用为开始时阻断或限制流动,并且随时间流逝允许更多的流动。例如,医生可在植入之后的某段时间移除丝或缝线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或缝线18可放置在每一凹槽中。在流动调节植入件中的丝或缝线用途的进一步说明在美国专利No. 6,558,342中提供,其披露内容结合在此作为参考。

[0039] 图6是图1所示流动调节植入件的透视图,围绕上述植入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植入件的一部分长度,或在替换方式中,其可延伸经过植入件的整个长度。带或涂层19可成形为以便延伸入凹槽中。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,以阻断或限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上以使得沿凹槽的通路畅通,并且流体会沿在植入件的杆和带或涂层19之间的凹槽流动。

[0040] 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10。流动调节植入件20具有杆21、凸缘22以及凹槽(凹槽26B未示出)。 在该实施例中,在凸缘中分别在凹槽26A,26B的出口端处具有孔27A,27B。这些孔允许流体从植入件流出并远离植入件。

[0041] 图8示出流动调节植入件的另一实施例。该流动调节植入件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36A,36B。在该实施例中, 在凸缘中具有孔38。由于具有该孔,可使用缝线来将植入件接附到组织上以将其固定就位。

[0042] 图9示出流动调节植入件40。该流动调节植入件40类似于上述的流动调节植入件。流动调节植入件40具有杆41、凸缘42以及凹槽46A,46B。在该实施例中,凸缘42具有不同的形状,其有利于特定的应用场合。

[0043] 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。植入件50具有贯穿通过上述植入件的管通路51。该管通路51提供适于流体流动的额外通路。上述管通路在其内可具有吸收性的、生物可降解的、激光可消融的和/或可移除的材料,以阻断或部分阻碍流体流动,并且随时间流逝允许进一步流动。图11示出图10的流动调节植入件,在上述管通路51中具有丝或缝线58。

[0044] 图12是流动调节植入件60的替换实施例的透视图,具有侧面销68形式的侧面突出部。在植入时,销68固定到巩膜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膜施加压力和侵蚀结膜的可能性。

[0045] 上述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,上述突出部或销可由吸收性的、生物可降解的、激光可消融的和/或可移除的材料制成。上述突出部或销68可沿孔在杆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。

[0046] 图13是流动调节植入件的替换实施例的透视图。植入件70包括两个部分71,72, 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。在植入件70中,上述两部分71,72借助两个圆柱体73A,74B彼此连接。植入件可形成为单件,或者上述部分可通过任何合适的手段例如焊接连接。上述两部分71,72可只通过一个圆柱体或通过其他形状的部分例如一个或多个球体连接。可替换的,上述两部分可被成形为直接连接在一起但是在之间具有间隔。应该意识到在上述部分71,72之间的间隔74提供了适于流体流动的空间并允许更多的流体接触巩膜。

[0047] 图14示出包括两个部分81,82的流动调节植入件80,上述两个部分一起形成为单一的整体的器件。应该意识到在上述部分81,82之间的间隔84提供了适于流体流动的空间并允许更多的流体接触巩膜,类似于植入件70。上述两部分81,82可被推到一起或移动分开,其可控制间距并从而控制流体的流动

[0048] 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,诸如不锈钢、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或聚合材料或其它材料。整个器件可由生物可降解材料制成。上述器件可通过模制或任何其它的合适制造方法来制作。上述器件可制作为单件或制作为组装在一起的单独件。上述植入件可用肝磷脂或任何其它合适的涂层涂敷。

[0049] 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/或通过其它方法植入,例如上述的美国专利No. 5,868,697 ;6, 203,513 ;6, 558,342中披露的那些方法。

[0050] 如同本领域的那些普通技术人员会意识到的那样,上述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、改型和改变应用于上述实施例,本发明的范围由附加的权利要求限定。

Claims (8)

1. 一种用于调节流体流动的植入件,所述植入件包括杆和凸缘,所述植入件具有入口端和出口端,其中所述植入件包括一个或多个位于所述杆侧面中的凹槽,以便使得流体流动;而且所述植入件还包括位于至少一个凹槽中的可移除或可降解或吸收性的材料。
2.权利要求1的植入件,其特征在于,至少一个凹槽的横断面沿其长度是恒定的。
3.权利要求1的植入件,其特征在于,至少一个凹槽是渐缩的。
4.权利要求1的植入件,其特征在于,位于至少一个凹槽中的所述材料是可移除材料, 该可移除材料是激光可消融的材料。
5.权利要求1的植入件,其特征在于,位于至少一个凹槽中的所述材料是可移除材料, 该可移除材料是可移除的丝或纱线。
6.权利要求1的植入件,其特征在于,还包括覆盖至少一个凹槽的至少一部分的弹性带或涂层。
7.权利要求1的植入件,其特征在于,还包括从所述杆的侧面延伸的突出部,以便将所述植入件锚固于组织中。
8.权利要求1的植入件,其特征在于,所述杆的横断面是非圆形的。
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