CN1354642A - 治疗青光眼的分流装置和方法 - Google Patents

治疗青光眼的分流装置和方法 Download PDF

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CN1354642A
CN1354642A CN00806812A CN00806812A CN1354642A CN 1354642 A CN1354642 A CN 1354642A CN 00806812 A CN00806812 A CN 00806812A CN 00806812 A CN00806812 A CN 00806812A CN 1354642 A CN1354642 A CN 1354642A
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flow arrangement
arrangement according
part flow
canal
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玛丽G·林奇
雷埃H·布朗
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GMP VISION RECOVERY CO
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    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • 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
    • A61F9/0008Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0017Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
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    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable

Abstract

用于持续地降低由青光眼引起的眼中升高的眼内压的分流装置和方法,它是将过多的房水从眼的前房转移到施莱姆管。利用手术连接施莱姆管和前房的留置的分流装置,可以维持施莱姆管在术后的开放状态。该分流装置在施莱姆管中提供单向或双向的房水流。

Description

治疗青光眼的分流装置和方法
相关申请的交叉引用
本申请要求1999年4月26日提交的美国临时申请No.60/131,030的权益。
技术领域
本发明总体涉及对青光眼的手术治疗,特别涉及一种通过将房水从眼睛的前房引流到施莱姆管(Schlemm′s canal)而持续地降低由青光眼引发的眼睛中升高的眼内压的装置和方法,施莱姆管可利用一个留置的分流器而维持术后开放,该分流器可利用手术放置,以使施莱姆管与前房相连。
发明背景
青光眼是一个严重的公众健康问题,因为青光眼是造成失明的一个主要原因。由青光眼导致的失明牵涉到中央视觉和周边视觉,并且对人的独立生活能力产生重大的影响。
青光眼是一种视神经病变(视神经障碍),它通常发生在眼内压升高的情况下。眼内压升高而使视神经的表象(“视盘陷凹”)和功能(在视野中的“盲点”)发生变化。如果该压力在一段足够长的时间内保持足够高,就会使全部视觉丧失,由于内部流体失调,高压在眼内发展。
眼睛是一个中空结构,其内含有称为“房水”的清澈流体。房水由睫状体以大约每分钟2.5微升的速率产生在眼睛的后房中。然后,这种以相当恒定的速率产生出来的流体围绕着晶状体流动,通过虹膜中的瞳孔的开口,并流入眼睛的前房。进入前房以后,该流体通过两条不同的路径流出眼睛。在“眼色素层巩膜”的路径中,该流体在睫状体的肌内纤维之间渗流。这条路径将大约10%的房水排出人体。使房水排出人体的主要途径是通过“小管”路径,此路径牵涉到小梁网(眼缘)和施莱姆管。
小梁网和施莱姆管位于虹膜和巩膜的接合处。这个接合处或角部被称为“角”。该小梁网是一个楔形结构,它围绕着眼睛的周边伸展。它由以三维网状结构排列的胶原束组成。这些束衬有一个被称为小梁细胞的单细胞层。在胶原束之间的空间中充填有由小梁细胞产生的细胞外物质。这些细胞也产生降解这种细胞外物质的酶。施莱姆管邻接小梁网。该小梁网的外壁与施莱姆管的内壁重合。施莱姆管为管状结构,它围绕着角膜的周边伸展。在成人中,施莱姆管被认为由中隔分成一系列自主的盲端管。
房水穿过小梁之间的空间,通过施莱姆管的内壁进入该管,通过一系列大约25个从施莱姆管排放的收集管通道并进入巩膜外静脉系统。在正常情况下,房水产生与房水外流的数量相等,眼内压保持相当恒定,其范围为15至21mmHg。在青光眼中,通过小管外流系统的阻力异常地高。
在作为青光眼的一种最常见形式的原发性开角型青光眼中,据信该异常阻力是沿着小梁网的外面和施莱姆管的内壁。据信小梁细胞的异常代谢将会使细胞外物质在此区域过度聚集或在此区域聚集异常“僵硬的”物质。原发性开角型青光眼大约占全部青光眼的85%。其他类型的青光眼(如闭角型青光眼和继发性青光眼)也牵涉到通过小管途径的外流降低,但却由于其他原因而使阻力增大,例如由于机械性堵塞、炎性碎片、细胞阻塞等等。
在阻力增大的情况下,房水由于不能足够快地排出而累积。随着房水累积,眼睛内的眼内压(IOP)升高。升高的眼内压压缩视神经的轴突,也会损害与视神经的维管联结。视神经将视觉从眼睛携带到大脑。有些视神经似乎比其他眼睛对眼内压更敏感。尽管正在研究保护视神经免受升高的眼内压损害的途径,但目前可用的青光眼的治疗措施只有降低眼内压。
对青光眼的临床治疗采取的是分阶段治疗方式。药物疗法通常是首选的治疗方式。通过局部或口服用药,使这些药物疗法达到降低房水产生或增大房水排出的效果。现行的药物疗法存在许多严重的副作用,这包括:充血性心力衰谒、呼吸窘迫、高血压、抑郁、肾结石、再生障碍性贫血、性功能障碍和死亡。对药物疗法的顺应性是一个主要问题,估计超过半数的青光眼患者不遵从正确的用药剂量时间表。
当药物疗法不能适当地降低压力时,通常就会实行激光小梁成形术。在激光小梁成形术中,来自激光的热能施加在小梁网中的许多非邻接点上。据信激光能量以某种方式刺激小梁细胞的代谢,并改变小梁网中的细胞外物质。在大约80%的患者中,房水的外流被增大并且眼内压降低,但是,这种疗效不持久,50%的患者在5年之内又发育成高眼内压。激光手术通常是不能重复的。此外,激光小梁成形术对于年龄小于50岁的原发性开角型青光眼患者来说并不是一种有效的治疗手段,同时对于闭角型青光眼和许多继发性青光眼来说也无效。
如果激光小梁成形术不能足够地降低压力,就要施行过滤手术。利用过滤手术,在巩膜和角部形成一个孔。这个孔使得房水可以通过一个替代的路径离开眼睛。
最常用的过滤操作是小梁切除术。在小梁切除术中,在结膜中,也即在覆盖巩膜的透明组织中,开一个后切口。结膜被向前卷,在缘处露出巩膜。做成一个具有部分厚度的巩膜瓣,将其以一半厚度剖割进入到角膜中。从巩膜瓣的下面进入前房,将一段深层巩膜和小梁网切除。将巩膜瓣松松地缝回就位。结膜切口被严密地闭合。手术后,房水通过巩膜瓣下面的孔流动并聚集在结膜下面的增加的空间中。然后,房水或者由结膜中的血管吸收,或者穿过结膜进入泪膜。
小梁切除术伴随出许多问题。存在于巩膜外层中的成纤维细胞会增生和游移,并能在巩膜瓣上结疤。特别是在儿童和年轻人中,可能会出现由于结疤而引起的失效。在最初成功地实行了小梁切除术的眼睛中,80%将会在手术后的3至5年内由于结疤而失效。为了最大限度地降低纤维样变性,现在外科医师在做手术时将抗纤维变性剂,如比裂霉素C(MMC)和5-氟尿嘧啶(5-FU),施加到巩膜瓣上。使用这些药剂增大了小梁切除术的成功率,但同时也增大了压力过低的患病数。压力过低是在房水流出眼睛太快时产生的一个问题。眼压降得太低(通过小于6.0mmHg);眼睛的结构萎陷,视力下降。
小梁切除术为房水排到眼睛表面创造了一条通道。与此同时,它也为正常生存在眼睛表面和眼睑上的细菌创造了一条进入眼睛的通道。如果出现这种情况,就会发生眼内感染,称之为眼内炎。眼内炎经常引发永久性和深度的视力损失。眼内炎可在小梁切除术后的任何时间发生。这个危险随着采用MMC和5-FU后生成的薄滤过泡而增大。促发感染的另一个因素是滤过泡的布置。经过不良的小梁切除术的眼睛比那些具有优良的滤过泡的眼睛发生眼内感染的风险要高约5倍。因此,在鼻或颞的四分体内,在眼睑的下面实行高质量的首次小梁切除术。
除了结疤、压力过低和感染之外,还存在其它的小梁切除术的并发症。滤过泡会破裂而引起深度的压力过低。滤过泡会具有刺激性并会破坏正常的泪膜,导致视力模糊。有滤过泡的患者一般不能戴接触透镜。由小梁切除术引发的所有并发症都起源于房水被从眼内转移到眼的外表面这一事实。
当小梁切除术不能成功地降低眼压时,下一个手术措施往往是采用房水分流装置。现有技术中的一种房水转移装置是一个聚硅氧烷管,其一端连到一个塑料(聚丙烯或其他合成塑料)板。利用房水分流装置,在结膜中开一个切口,露出巩膜。塑料板从后面,通常在中纬线上方,缝到眼睛的表面上。通常用针在缘处在眼中开一个全厚度孔。通过此孔将所述管插入眼中。该管的外部由供体巩膜或心包膜覆盖。将结膜复位并将切口严密闭合。
利用现有技术的房水转移装置,房水通过聚硅氧烷管从眼内排到眼睛表面。然后更深的眼眶组织吸收房水。该管的外侧端由塑料板来防止产生成纤维细胞和结疤。许多并发症与房水分流装置有关联。围绕着塑料板生成的疤痕组织的增厚的壁对房水外流提供某种阻力,并且在许多眼中限制了眼压的降低。在某些眼中,则由于通过管的流动不受限制而造成眼压过低。许多医师围绕着该管系一条吸收性缝线,希望等到术后该缝线溶解时已有足够的疤痕组织在塑料板周围形成。一些装置在管中含有压每阀,尽管这些阀可能不会适当地工作。这种手术牵涉到在后眶内进行手术,许多患者在术后会产生眼肌失调和复视觉。利用现有技术的房水分流装置,也为细菌进入眼睛制造了一条通道,潜在地会引发眼内炎。
在现有技术中有多种这样的房水分流装置,例如US4,936,825(提出一种用于治疗青光眼的从前房到角膜表面的管状分流器),US5,127,901(针对一种从前房到结膜下空间的跨巩膜分流器),US5,180,362(提出一种螺旋形钢制植入物,它设置成提供从前房到结膜下空间的排放通道),和US5,433,701(一般地提出从前房到巩膜或到结膜空间的分流)。
除了上述现有技术的房水分流装置以外,其他用于青光眼手术的现有技术装置已经使用泄液线,或其他多孔灯芯式元件,以便从前房到外眼表面转移和输送过多的房水。这种例子包括US4,634,418和US4,787,885(提出使用由三角形泄液线(灯芯)构成的植入物手术治疗青光眼),和US4,946,436(提出使用一种多孔装置从前房分流到巩膜下空间)。这些专利都没有提及在施莱姆管中的安置。
一些有关青光眼治疗的现有技术文献已涉及到施莱姆管,但都没有论及长期留置的分流器的放置。US5,360,399提出一种具有预制曲率的塑料或钢管在施莱姆管中的暂时放置,通过该管注射粘性物质以液压扩张和水分离小梁网。在注射之后从施莱姆管中取出该管。因为该管是从眼睛向外定向的,以便注射时操纵它,所以外流元件与施莱姆管内的预制的弯曲的元件的交接面相对于曲率平面成大约90°角,而偏离前房180°。因此,US5,360,399的装置的任何部分在任何时候都不与前房连通。另外,相对于位于施莱姆管内的那部分,该管具有一个较大直径的注射根套件,此件用作为灌注的适配器。因此,这种装置不适用于在前房和施莱姆管之间分流房水。
由于房水被从眼内测排到眼的表面,围绕着现有的青光眼治疗装置和方法而产生的大多数问题都已经出现了。这样,就需要有一种更符合生理学要求的系统,以提高房水从前房到施莱姆管的排放。在绝大多数青光眼患者中,阻力问题存在于施莱姆管和前房之间。施莱姆管本身、收集通道和巩膜外静脉系统都不受到损伤。增加直接流入施莱姆管的房水将最大限度地减少通常采用外部过滤操作而产生的结疤,这是由于内角区域由单线非增生的小梁细胞填充。增加直接流入施莱姆管的房水将最大限度地减少压力过低的问题,这是因为施莱姆管是作为正常的外流系统的一部分,并且在生物学上被构造成用来掌控房水的正常体积。增加直接流入施莱姆管的房水还将消除象眼内炎和泄漏这样的并发症。
发明内容
本发明涉及一种治疗青光眼的新颖的分流器和与之关联的手术方法,其中该分流器放置成将房水从眼的前房转移到施莱姆管中。本发明因此促进用于将房水排出前房的正常生理通道,而不是象大多数现有技术的分流装置所做的那样,将房水分流到巩膜或另外的解剖学部位。本发明进一步提供一种永久留置的分流器,以便为青光眼的治疗提供从前房到施莱姆管的房水的增大的出路。
附图说明
图1A为一个图示本发明的一个实施例的俯视立体图,其中,本发明的分流器包括在施莱姆管中双向延伸的管状元件。
图1B是图1A所示的本发明的实施例的一个俯视图,其中以剖面线具体示出了包含有本发明装置的管状元件的管腔之间的内部连通结构。
图1C是图示本发明的一个实施例的俯视立体图,其中,本发明的分流器包括在施莱姆管内双向延伸的网式管状元件。
图1D是图示本发明的一个实施例的俯视立体图,其中本发明的分流器包括在施莱姆管内双向延伸的实心多孔元件。
图1E是本发明的另一个实施例的俯视立体图,其中以虚线具体示出了本发明装置的两个近侧管腔和一个单一的远侧管腔的内部连通结构。
图2是图示本发明的另一个实施例的视图,其中,本发明的分流器包括有带孔的管状元件,并带有近侧部分的弯转的末端部。
图3A是图示本发明的另一个实施例的立体图,其中,本发明的分流器包括其构造为部分呈管状而部分呈开口状的元件。
图3B是图3A所示的本发明的实施例的顶视图,其中以虚线具体示出了该装置的内部连通结构。
图3C为从图3A所示的本发明实施例的近侧端看去的侧视图。
图3D为图示本发明的另一个实施例的立体图,其中,本发明的分流器包括其构造为部分敞开并呈槽状的元件。
图4为图示本发明的另一个实施例的视图,其中,本发明的分流器包括在其末端部带有灯芯式延伸部分的远侧元件,并且其中近侧部分具有一个密封的弄钝的顶部,该顶部带有一个与近侧部分的管腔连接的门口,当该装置植入施莱姆管内时,该门口背对虹膜。
图5A是图示本发明分流器的另一个实施例的视图,其中,该装置的一部分仅沿一个方向进入施莱姆管并将房水沿一条非线性的通路从前房分流出去。
图5B是图示本发明的分流器的一个可替换的实施例的视图,其中,整个分流器安置在施莱姆管中,但它含有一个穿孔,以维持一个从前房到施莱姆管的房水流体出口。
图5C是本发明的一个实施例的侧视图,其中,本发明的分流器包括管状件,其朝向前房延伸的近侧部分比在施莱姆管中双向延伸的远侧部分短。
图5D是图示本发明的分流器的一个可替换的实施例的视图,此分流器包括一个部分敞开的槽状元件,该元件安置在施莱姆管中,但包含有一个门口,以维持一个从前房到施莱姆管的房水流体出口。
图5E是图示本发明的分流器的一个可替换的实施例的视图,该分流器包括一个实心但多孔的灯芯式元件,它被安置在施莱姆管内。
图6A示出了人眼的某些解剖学细节。
图6B是表示本发明的一个示例性实施例的手术放置的解剖学关系的横截面图。
图6C是表本发明的另一个示例性实施例的手术放置的解剖学关系的横截面图,其中,近侧部分具有一个弯转的末端部,其上带有一个密封的弄钝的顶部,该顶部具有一个与近侧部分的管腔连接的门口,当该装置植入施莱姆管内时该门口背对虹膜。
本发明的详细说明
本发明提供一种房水分流装置,以将眼内的房水从前房转移到施莱姆管中。其中,该分流装置包括一个远侧部分和一个近侧部分。该远侧部分具有至少一个末端部,其尺寸和形状制成可被沿周边收容在一部分施莱姆管中。该近侧部分具有至少一个末端部,其尺寸和形状可被装在眼睛的前房中。其中,该分流装置允许从位于前房中的近侧部分到位于施莱姆管中的远侧部分的流体连通。如下所述,利用近侧部分或远侧部分中的房水引导通道,能促进流体连通。利用例如分流装置的实心的近侧或远侧部分的灯芯虹吸作用也可促成流体连通。
本发明也提供一种所发明的分流器的实施例。该分流器包括一个由生物适应性材料制成的主体,该主体的尺寸和形状被制成能适于至少部分地沿周边套装在一部分施莱姆管中,以将房水从人眼的前房转移到施莱姆管中。其中,该主体促成从前房到施莱姆管的房水通道。本发明装置的这个实施例可制造成没有先前的实施例上伸入前房的近侧部分。房水引导通道能促进从前房到施莱姆管的房水通道。利用例如实心主体部分的灯芯虹吸作用也能促成流体连通。
本发明设想出房水引导通道的许多不同的构造,只要求每种构造例如通过提供管腔、水槽、灯芯或毛细管作用来有助于开通从前房到施莱姆管的房水通道。例如,房水引导通道可以是一个全封闭的管腔、一个部分封闭的管腔、或一个至少部分敞开的槽状通道。本发明还构想将实心的单丝或编织的聚合物,如脯氨酸,插入到施莱姆管中,以提供一种灯芯式(虹吸)作用来促成从前房到施莱姆管的房水通道。可以沿着这种灯芯式延伸部的部分长度在其上开槽或刻槽,以使其具有多角或星形横截面。本发明装置可由实心、基质、网状、穿孔或多孔材料,或它们的组合物来制造。
传统的青光眼学说指出,成人的施莱姆管被中隔分成多个分立的管,使得不可能提供一条缝的完整的通道。对成年人眼库中的眼的初步研究表明,施莱姆管确实是开放的。一条缝可以贯穿管的整个周边。不过至今尚未确定在正常成年人中的施莱姆管是贯穿其周边开放的,这是与那种认为中隔将施莱姆管分为多个盲端管的观点相对立的。本发明利用了这种知识来对待施莱姆管,以产生和保持从前房到施莱姆管和到收集通道的房水的自然生理出口。
本发明也提供使用这种分流装置的方法。本发明的一个实施例针对一种手术方法,以利用一个植入成从前房内延伸到施莱姆管的装置来将房水从眼的前房转移到施莱姆管中。该装置的伸入施莱姆管的部分可由柔性材料制成,它能被接收在施莱姆管的一部分半径、曲率和直径中。该装置的所有或部分元件可以是实心、多孔、管状、槽状、穿孔或预弯曲的。
图1A中示出了本发明的一个实施例,其中,以侧视图示出分流装置100,此实施例的分流装置100包括两个部分,一个近侧部分10连接一个远侧部分25。所示的近侧部分10和远侧部分25构成一个封闭的管状通道结构。远侧部分25的总长可在大约1和40mm之间,最好约为6mm。在图1B中以剖面线示出了本发明的这个实施例的内部流体连通路径。由近侧部分10和远侧部分25的壁限定的管腔或通道空间在这两部分的交接处的远侧部分的门口20连通。
图1C示出了本发明的一个可替换的实施例,其中,分流装置100包括两个带腔的网状元件,一个近侧部分10连接一个远侧部分25。图1D示出了本发明的另一个实施例,其中,分流装置100包括两个实心的多孔元件,该两元件可在其内提供象灯芯那样的流体连通,一个近侧部分10连接一个远侧部分25。
图1E示出了本发明的一个可选择的实施例,其中,分流装置100包括一个近侧部分10,其内具有两个管腔,两管腔终止于近侧部分的门口18。形状和尺寸制成可装在施莱姆管内的远侧部分25,沿两方向中任一方向延伸成使分离的管腔从远侧部分的门口20横向穿过。
图2-5D示出了本发明的其它实施例。图2示出了本发明的分流装置的一个实施例,该装置100为管状并且在其构造中制有穿孔(15,30),在近侧部分10和远侧部分25限定的平面之间的交接处形成一个锐角(<90°)。这些穿孔(15,30)可沿装置100的任何部分设置,以促成通过穿孔的流体通道,这些穿孔可特别指向眼睛的收集通道。图2还示出了本发明的一个可选择的实施例,其中,近侧部分的末端部16相对于近侧部分10的主轴朝着虹膜40弯转,使近侧部分的门口18指向虹膜40。在图6C所示的可替换的实施例中,近侧部分16的门口18背向虹膜40。
图3A示出了本发明的分流装置一个实施例,其中,分流装置的一部分在近侧部分10和远侧部分25的接合部是封闭的和管状的,但远侧部分10是槽状的通道。图中还示出了远侧部分的门口20。本发明构想出装置100的任何部分可以是半管状的,敞开的和槽形的,或者是灯芯式的延伸物。管状通道可以是圆形的、卵形的,或其它任何封闭的几何形状。最好,非管形的槽状部朝后定位在施莱姆管的外壁上,以促使房水排到眼睛的收集通道,如图3A所示。
图3B为图3A所示的本发明分流装置的实施例的俯视图,进一步详示了近侧部分10和远侧部分25之间的关系。房水引导通道用虚线表示。图3C为图3A所示的本发明的分流装置的实施例的从近侧部分看去的视图,进一步详示了近侧部分和远侧部分25之间的关系。
图3D示出了本发明的分流装置的另一个实施例,其中,装置100的结构包括一个房水引导通道,该通道是敞开的和弯曲的,并且沿着近侧部分10和远侧部分25呈连续的槽状结构。远侧部分的门口20也是敞开的槽状通道。
图4示出了本发明的分流装置的另一个实施例,此装置附加有用于房水的灯芯式延伸部32,该延伸部可以是远侧部分25的末端部的连续延伸部,或者被另外连接到该末端部上。灯芯式延伸部32可由单丝或编织的聚合物,如脯氨酸制成,其长度最好为1.0mm至16.0mm。另外,近侧部分10是弯曲的,带有一个密封的弄钝的顶端16,并包含有一个与近侧部分的管腔流体连通的门口18,在分流装置100被植入到预期的解剖学位置时,该门口18定向成背向虹膜。分流装置100也有助于将施莱姆管保持在扩张的开放状态。
图5A示出了本发明的分流装置的另一个实施例,其中,近侧部分10连接一个单一的、弯曲的远侧部分25,形成V形的管状构造。图5A所示的实施例也可在远侧部分25与近侧部分10邻的部位具有一个门口(未示出),以助于促进流体在施莱姆管中的双向流动。在本发明的所有实施例中,均可采用穿孔和非管状的槽状末端开口,这些穿孔和开口可以为圆形、卵形或其他为在相关的解剖学部位提供理想的房水引流作用所需的形状。
图5B示出了本发明的分流装置的另一个实施例,其中,主体或装置100仅包括一个单一的、弯曲的远侧部分25,该远侧部分包含有一个指向前房的远侧部分的门口20,以允许房水从前房流到施莱姆管。此装置的主体的长度可为大约1.0mm至40mm,最好约为6mm。外径可为大约0.1mm至0.5mm,或约为0.3mm。
图5C示出了本发明的分流装置的另一个实施例,其中,该装置100包括一个双向管状远侧部分25,该远侧部分与一个近侧部分10交接,该近侧部分的长度比远侧部分25的短,并指向前房。
图5D示出了本发明的分流装置的又一个实施例,其中,该装置100包括一个要插入施莱姆管中的双向的槽状弯曲的远侧部分25,该远侧部分包含有一个用于让房水从前房流出的远侧部分的门口20。其中,槽状的远侧部分25定向成朝着收集通道敞开,以促使房水流出。
图5E示出了本发明的分流装置的另一个实施例,其中,该装置100包括一个用于插入施莱姆管中的双向的实心的远侧部分25,以便利用灯芯作用来促使房水从施莱姆管流到收集通道。该实心的远侧部分25可以是多孔的或非多孔的。
由于所发明的装置是一种植入物,所以它要用能与它所要接触的组织和流体相容的材料制成。最好,这种装置在它的使用期间不会被吸收、腐蚀,或出现其他结构性损害。另外,同样重要的是,要保证眼组织和房水不会因植入的装置而受到有害的影响。现有的一些材料可以满足对分流装置的工程和医学规范。在本发明的一个示例性实施例中,分流装置100由生物学惰性的柔性材料,如聚硅氧烷或类似的聚合物制成。其他可供选择的材料可以包括(但并不限于此):薄壁聚四氟乙烯、聚丙烯、其他聚合物或塑料、金属、或这些材料的一些组合物。在可选择的实施例中,分流装置100可做成多孔的或者实心的。所述材料可以含有能释放到相邻组织中的治疗剂。
在图1-4所示的实施例,近侧部分10以一个角度连接远侧部分25,该角度足以使得当远侧部分25定位在施莱姆管的平面中时近侧部分15能置放在眼睛的前房内。近侧部分10最好具有足够的长度,约为0.1至3.0mm或约2.0mm,以便从与施莱姆管中的远侧部分25的交接处朝着前房的邻接空间延伸。虽然可以为了导引房水而采用许多几何尺寸,但近侧部分10的直径或宽度,对于管状或弯曲的分流装置来说,可被制订成要形成一个约在0.1和0.5mm之间、最好为0.20mm的内径,或者对于多角形结构的分流装置来说,要被制订成应形成一个可匹配的最大宽度。在其它实施例中,近侧部分是一个无腔的、非槽状的灯芯式延伸物,它沿其长度提供一条房水引导通道。
由于虹膜40的性质是它趋于包括多个相当柔软的组织伞,所以希望避免将所述伞拉进植入物的管腔,以防堵塞分流装置。因此,近侧部分10可包含有多个穿孔,它们设置成可防止被邻接的虹膜堵塞,以允许房水流入。或者,近侧部分10可仅包含一个指向前面的穿孔形式的近侧部分的门口18,以便在眼睛的前房和分流装置的引导通道之间提供连续的流体出口。在本发明的各种各样的实施例中,所述穿孔可以具有任何功能性尺寸,可以是圆形或非圆形的。此外,多孔结构材料能有助于导引房水,同时可大为降低吸入所述伞的倾向。
另外,近侧部分10可以定位在距虹膜40足够远处,以防止与虹膜产生干拢,例如使小梁网的靠前部进入周边的角膜组织。在另一个可能的实施例中,如图6C所示,装置100可包括一个近侧部分10,其中,该近侧部分10的末端部是朝着虹膜40弯曲或转角的,并带有一个弄钝的密封的顶端16和一个朝前定向而背对下面的虹膜40的门口18。这种结构将趋于减小分流装置被虹膜40闭塞的可能性。
装置100可包含有一个或多个单向阀,以防止从施莱姆管到前房的回流。该装置的闭合部分的内腔或该装置的敞开部分的边限定的内部通道,在近侧部分的门口20与远侧部分的内腔或通道直接连接。
远侧部分25可具有预成形的曲线,以近似于人眼内施莱姆管的6.0mm的半径。当使用柔性材料制造分流装置100时,就不需要这种预成形的曲度。远侧部分25可具有足够的长度,以便从与近侧部分10的交接处伸过施莱姆管的整个周边的一段长度。具有一个在施莱姆管内沿双方向延伸的远侧部分25的实施例,可在每个方向延伸大约1.0mm至20mm,或大约为3.0mm,以便通过施莱姆管进行周边定位。远侧部分25的直径或宽度,对于管状或弯曲的分流装置来说,可被制定成要形成一个在大约0.1mm和0.5mm之间或大约0.3mm的外径,或对于具有多角形结构的分流装置来说,被制订成要形成一个可匹配的最大宽度。远侧部分25可包含有多个供流体流出的穿孔,它们设置成可防止被施莱姆管的邻接壁所闭塞。在其它的实施例中,远侧部分是一个无腔的、非槽状的灯芯式延伸物,它沿其长度提供一条房水引导通道。
在本发明的一个示例性实施例中,分流装置可以是双向的,其中,植入物的远侧部分与近侧部分呈T形交接,如图1A-1E、2、3A-3D、4和5C所示;或者分流装置也可以是单向的,其中,近侧与远侧部分呈V形交接,如图5A所示。双向的分流装置可具有一个拧入施莱姆管的两相对部的远侧部分。在单向的分流装置中,仅仅远侧部分安置在施莱姆管内。在这些示例性实施例中,“非线性流体连通”指的是至少分流装置的供流体通过的某些部分不是直线型的。非线性分流装置的例子包括上述的双向T形和单向V形,或具有两个彼此未直线对准的通道口的分流装置。
图6A示出了与本发明有关的外科解剖。一般地说,图6A示出了前房35、施莱姆管30、虹膜40、角膜45、小梁网50、收集通道55、巩膜外静脉60、瞳孔65和晶状体70。图6B示出了本发明示例性实施例的手术放置,以及相关的解剖关系。应注意的是,本发明的装置被设计成,远侧部分25在施莱姆管30内的安置导致在前房35内的近侧部分10的方位处在由虹膜40和角膜45的内表面限定的角度之内。因此,如果由施莱姆管限定的平面被定义成零度,那么近侧部分10可从此以这样一个角度延伸,该角度为向着角膜45的大约+60°或向着虹膜40的-30°之间,更好地为0至+45°范围。这个角度范围可以因人而易,每个人的施莱姆管30相对于前房35的缘角的位置稍有不同。
在未示出的本发明的另一个实施例中,分流装置100制有一个管状的远侧部分25和多个近侧部分10,该远侧部分用于提供分流功能,该近侧部分除了提供从前房到施莱姆管的流体连通之外,还提供一种锚定功能,以稳定住整个植入装置。
植入所述装置所需的手术操作要求有一个通过一个结膜瓣的进路。然后制出一个部分厚度的巩膜瓣并将其以一半厚度剖割进入清澈的角膜中。找到施莱姆管的后部并从后面进入施莱姆管。利用注射粘弹性的缩瞳剂来加深前房。然后将分流装置的近侧部分通过施莱姆管的内壁和小梁网插入处于虹膜和角膜之间的角内的前房中。在某些情况下,也许需要开一个从施莱姆管通过小梁网进入前房的切口,以促成近侧部分在此贯通的通路。将分流装置的远侧部分的一个壁握住并拧到施莱姆管中。以类似的方式将分流装置的远侧部分的另一个臂(如果有的话)沿与前一个臂相反的方向插入到施莱姆管中。以常规的方式将巩膜瓣和结膜伤口封闭。
尽管上述实施例是示例性的,但本发明包含了分流装置的各种变化的形状和结构,以便在前房和施莱姆管之间提供流体连通。因此,上述实施例并不用于限制权利要求及其等同物的范围。

Claims (47)

1.一种用于将眼中的房水从前房转移到施莱姆管中的房水分流装置,所出分流装置包括一个远侧部分和一个近侧部分,所述远侧部分具有至少一个其尺寸和形状制成为可被沿周边收容在所述施莱姆管的一部分内的末端部,所述近侧部分具有至少一个其尺寸和形状制成为可被收容在所述眼的前房内的末端部,其中,所述分流装置允许从所述前房中的近侧部分到所述施莱姆管中的远侧部分的流体连通。
2.根据权利要求1所述的分流装置,其中,所述分流装置的远侧部分具有一曲线部,该曲线部的半径近似于人眼的施莱姆管的半径。
3.根据权利要求2所述的分流装置,其中所述曲线部的半径在大约3mm和10mm之间。
4.根据权利要求2所述的分流装置,其中,所述曲线部的半径约为6mm。
5.根据权利要求1所述的分流装置,其中,所述分流装置的近侧部分与所述远侧部分交接,并且其中所述远侧部分从与近侧部分的交接处沿两个相反的方向分叉,以允许由前房沿着施莱姆管的两个方向中的任一方向的流体连通。
6.根据权利要求5所述的分流装置,其中,分流装置的近侧部分在远侧部分的长度的大约中点处与远侧部分交接。
7.根据权利要求1所述的分流装置,其中,远侧部分在施莱姆管内沿一个方向延伸。
8.根据权利要求1所述的分流装置,其中,近侧部分以一个角度从远侧部分伸出,以便当远侧部分位于施莱姆管内时,防止与角膜内皮组织或虹膜组织接触而造成闭塞。
9.根据权利要求1所述的分流装置,其中,远侧部分具有约为0.1mm至0.5mm的外径。
10.根据权利要求1所述的分流装置,其中,远侧部分具有约为0.30mm的外径。
11.根据权利要求1所述的分流装置,其中,近侧部分是管状的,它具有一个内径约为0.1mm和0.5mm之间的管腔。
12.根据权利要求1所述的分流装置,其中,近侧部分是管状的,它具有一个内径约为0.2mm的管腔。
13.根据权利要求1所述的分流装置,其中,近侧部分具有约为0.1mm至3mm的长度。
14.根据权利要求1所述的分流装置,其中,近侧部分具有约为2mm的长度。
15.根据权利要求1所述的分流装置,其中,远侧部分具有约为1mm至20mm的长度。
16.根据权利要求1所述的分流装置,其中,远侧部分具有约为6mm的长度。
17.根据权利要求1所述的分流装置,其中,远侧部分具有一个贯通的管腔,它提供进入施莱姆管的流体通路。
18.根据权利要求1所述的分流装置,其中,远侧部分具有多个穿孔,它们提供进入施莱姆管的流体通路。
19.根据权利要求1所述的分流装置,其中,近侧部分具有一个贯通的管腔,它促成进入分流装置的远侧部分的流体通路。
20.根据权利要求1所述的分流装置,其中,近侧部分具有两个贯通的管腔,它们促成沿两相反方向进入分流装置的远侧部分的流体通路。
21.根据权利要求1所述的分流装置,其中,近侧部分具有多个穿孔,它们促成进入分流装置的远侧部分的流体通路。
22.根据权利要求21所述的分流装置,其中,近侧部分的管腔与一个或多个穿孔连通,所述穿孔定向成向着角膜内表面且背离虹膜敞开。
23.根据权利要求1所述的分流装置,其中还包括多个与远侧部分交接的近侧部分。
24.根据权利要求1所述的分流装置,其中,从所述远侧部分的末端部伸出有一个长度约为1.0mm至16.0mm的房水灯芯虹吸作用式延伸物。
25.根据权利要求1所述的分流装置,其中,至少远侧部分的一部分是部分敞开的槽状通道,它向后朝着眼睛的收集通道敞开。
26.根据权利要求1所述的分流装置,其中,至少分流装置的一部分是由多孔材料制成的。
27.根据权利要求1所述的分流装置,其中,所述近侧部分的末端部相对于近侧部分向内朝着前房弯转。
28.一种用于眼中的房水分流装置,它通过促进从眼的前房到施莱姆管的排放而降低眼内压,它包括:
一个由生物学适应性材料制成的主体,它的尺寸和形状适于促成从眼的前房到施莱姆管以及在该管中的房水通路;
所述主体的长度和形状适于至少部分地沿周边被保留在施莱姆管的一部分之内,以促成从前房到施莱姆管的房水通路。
29.根据权利要求28所述的分流装置,其中,所述分流装置的主体具有一曲线部,该曲线部的半径近似于人眼的施莱姆管的半径。
30.根据权利要求30所述的分流装置,其中,所述曲线部的半径在大约3mm和10mm之间。
31.根据权利要求30所述的分流装置,其中,所述曲线部的半径约为6mm。
32.根据权利要求28所述的分流装置,其中,所述主体具有一个近侧部分和一个远侧部分,该近侧部分具有至少一个用于安置在前房中的末端部,该远侧部分具有至少一个用于安置在施莱姆管中的末端部。
33.根据权利要求32所述的分流装置,其中,近侧部分与远侧部分交接,并且其中,远侧部分从与近侧部分的交接处沿两个相反向分叉,以允许沿着施莱姆管的两个方向中的任一方向与前房流体连通。
34.根据权利要求33所述的分流装置,其中,近侧部分在或靠近远侧部分的长度的中点处与远侧部分交接。
35.根据权利要求32所述的分流装置,其中,近侧部分以一个角度从远侧部分伸出,该角度足以防止当远侧部分位于施莱姆管内时与角膜内皮组织或虹膜组织接触而造成闭塞。
36.根据权利要求28所述的分流装置,其中,所述主体至少沿其部分长度限定一条管状通道。
37.根据权利要求28所述的分流装置,其中,所述主体是管状的,并具有约为0.1mm至0.5mm的外径。
38.根据权利要求28所述的分流装置,其中,所述主体是管状的,并具有约为0.3mm的外径。
39.根据权利要求28所述的分流装置,其中,所述主体具有约为1mm至20mm的长度。
40.根据权利要求28所述的分流装置,其中,所述主体具有约为6mm的长度。
41.根据权利要求28所述的分流装置,其中,从所述主体伸出有一个长度约为1.0mm至16.0mm之间的房水灯芯虹吸作用式延伸物。
42.根据权利要求28所述的分流装置,其中,所述主体至少沿其部分长度限定一个部分敞开的槽状通道,它朝着收集通道敞开。
43.根据权利要求28所述的分流装置,其中,所述主体至少沿其部分长度制有穿孔,以提供与管腔的连通。
44.根据权利要求28所述的分流装置,其中,所述主体提供沿施莱姆管的一个方向的排放。
45.根据权利要求28所述的分流装置,其中,所述主体提供沿施莱姆管的两个方向的排放。
46.一种用于手术治疗青光眼的方法,它包括:通过在缘部制出的结膜瓣实行小梁切开术;切出一个部分厚度的巩膜瓣;径向切开角组织和巩膜之间的接合部,对其进行手术扩展直至从后面进入施莱姆管,并将权利要求1的分流装置放置在前房和施莱姆管之间。
47.一种用于手术治疗青光眼的方法,它包括:通过在缘部制出的结膜瓣实行小梁切开术;切出一个部分厚度的巩膜瓣;径向切开角组织和巩膜之间的接合部,对其进行手术扩展直至从后面进入施莱姆管,并将权利要求28的分流装置放置在前房和施莱姆管之间。
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CN103932840A (zh) * 2007-09-24 2014-07-23 伊万提斯公司 眼部植入物及方法
CN105578990A (zh) * 2013-07-08 2016-05-11 环形有限公司 基质内角膜插入件
CN105997341A (zh) * 2016-04-21 2016-10-12 温州医科大学附属眼视光医院 一种青光眼内引流替代仿生支架的制备及其使用方法
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