CN101005873A - 用于眼内近程治疗的方法和设备 - Google Patents

用于眼内近程治疗的方法和设备 Download PDF

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CN101005873A
CN101005873A CNA2005800047488A CN200580004748A CN101005873A CN 101005873 A CN101005873 A CN 101005873A CN A2005800047488 A CNA2005800047488 A CN A2005800047488A CN 200580004748 A CN200580004748 A CN 200580004748A CN 101005873 A CN101005873 A CN 101005873A
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CN101005873B (zh
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理查德·希尔斯泰德
查里斯·拉森
鲁洛夫·特里
赖纳·平泰斯克
赛宾·贝尔曼
埃伯哈德·弗里茨
尤金·德胡安
马克·胡马云
格尔德·T·菲利普斯
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NEOVISTA Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1014—Intracavitary radiation therapy
    • A61N5/1017—Treatment of the eye, e.g. for "macular degeneration"

Abstract

公开了一种用于执行眼内近程治疗的方法和执行该方法的设备。该设备优选地包括将放射源推进到相连的邻近于目标组织定位的套管或探针中的手持传递装置。机头提供了当放射源从套管回撤时对放射源的罩护存储并且包括用于推进和撤回所述放射源的滑块机构。将所述放射源安装在具有柔韧远端和相对较硬近端的导线上。还公开了用于所述套管的定位系统。

Description

用于眼内近程治疗的方法和设备
技术领域
本发明涉及用于执行眼内近程治疗的设备、系统和方法。该发明可用于治疗各种眼部病症，而且特别适用于治疗黄斑变性，其中通过将放射源所发出的放射剂量局部地直接传递到目标组织上来治疗新形成血管的眼部组织。
背景技术
中央视觉的缓慢、进展性丧失被称为黄斑变性。黄斑变性对黄斑，即视网膜的一小部分，产生影响。视网膜是覆盖眼睛内部后面部分的光感神经细胞的精细层。黄斑是在视网膜的中央靠后部分并且含有最集中的光感受体。黄斑直径典型地为5到6mm，并且它的中央部分被认为是个小凹。虽然视网膜的所有部分都对视力起作用，但是黄斑提供了清晰地观察物体和包括阅读与驾驶在内的日常活动所需的敏锐、中央的视觉。
黄斑变性通常由年龄(称作与黄斑变性有关的年龄或“AMD”)或用眼恶劣的条件所造成的。吸烟和患有循环问题的个体具有发展这种条件所增加的风险。发达国家中年龄大于50岁的人群中AMD是导致失明的首要原因。在52-64之间的年龄段中，接近2％的人群受到影响。这一比例在超过75岁的人群中上升到令人吃惊的28％。
存在两种形式的黄斑变性，它们被称为“湿”和“干”黄斑变性。干黄斑变性随着时间的流逝缓慢地使中央视觉模糊。患有这种形式的黄斑变性的个体会经历尤其是当试图阅读时能明显注意到视觉的变暗和变形。在干黄斑变性中，在黄斑的下方发展出被称为玻璃疣的淡黄色沉淀。玻璃疣是脂肪沉淀的堆积，年龄大于50岁的大多数个体都具有至少一个小的玻璃疣。这些脂肪沉淀通常由给视网膜运送营养物的血管运走。然而，这一过程在黄斑变性中被减少了且造成沉淀增大。当黄斑内的光感细胞层由于随着时间的流逝细胞被毁掉而变薄时也导致了干黄斑变性。通常，在一只眼睛中患有干形式的黄斑变性的人最终会在两只眼睛中都发展出视觉问题。然而，干黄斑变性很少引起阅读视觉的完全丧失。
湿黄斑变性(其是新生血管形式的疾病)比干黄斑变性更严重。由于湿黄斑变性引起的视觉丧失也比干黄斑变性来的更快。在这种形式的疾病中，不希望的新血管在黄斑下生长(脉络膜新血管形成(CNV)内皮细胞)。这些脉络膜血管很脆弱并且渗漏流体和血液，这引起组织的分离并损坏视网膜内的光感细胞。例如，患有这种形式的黄斑变性的个体典型地经历过诸如将直线看成波浪状和在他们的视野中能看到黑点等明显的视觉变形。
湿形式的黄斑变性的早期诊断是非常关键的。如果允许持续地从脉络膜血管中渗漏或出血，则黄斑内大量的神经组织将被杀死或损坏。这种损坏是不能修复的，因为一旦黄斑的神经细胞被毁坏，它们不能够再次生长。虽然湿AMD仅占总共AMD病例的20％，但是它是造成接近90％的由于AMD而视觉丧失的原因。
已经有人建议提供一种特别适用于局部传递放射来治疗黄斑变性的设备。参见DeJuan等人的U.S.专利申请公开号US2002/0115902A1，其作为参考合并与此。通过执行视网膜切割术并使用视网膜下输液针通过在此处注射盐水产生局部视网膜剥离(被称为“气泡(bleb)”)，这样在部分剥离的视网膜与脉络膜新血管形成区域之间产生一个空间。将放射发散源引入到气泡中并直接对CNV进行照射。将形成于湿形式黄斑变性期间的新血管暴露在放射中，给新血管细胞的细胞结构提供足够的破坏力以逆转、防止或减小黄斑变性疾病过程的进展。这种治疗潜在地能够恢复视敏度、延长视敏度的保持时间或延缓视敏度丧失的进展。
发明内容
本申请涉及通常用于执行眼内近程治疗，特别是利用放射治疗黄斑变性的设备、系统和方法的进展。
附图说明
图1是用于执行眼内近程治疗设备的部分纵向剖面图，包括机头，牢固到该机头的套管，和该机头与套管内在回撤位置上的放射源导线(“RSW”)。
图2是具有推进到治疗位置的放射发散元件的图1设备的剖面图。
图3是包括图1中所示机头部分的一部分外壳的顶视图(相对于图1和2)。
图4是与局部截面的图1系统有关联的套管的放大图。
图5是形成图1中所示系统一部分的放射源导线的不完整剖面图。
图6是套管远端和包括套管一部分顶或远端的剂量平稳过滤器的透视图。
图7是用于图1系统的定位系统第一实施例的分解透视图。
图8和9阐述了与图1系统有关的图7定位系统的使用。
图10是显示了用图1的装置治疗CNV的放大图。
图11显示了在传递装置治疗一侧的剂量率图线。
图12是用于本发明的在其远端具有膨胀气囊的套管的另外样式的原理图。
图13是包括回撤导线的图1套管的可选实施例的原理图，用于适当地将套管的治疗末端和放射源与目标组织隔开。
图14是套管可选样式的原理图，其中设置回撤导线筐用于维持放射源关于目标组织的适当间隔。
图15是用于本发明的套管另外实施例的原理图，其中该套管包括在套管远端位置用于注射和抽取各种流体的管腔。
图16是图15套管的剖面图。
图17是使用与本发明有关的套管的另外实施例的原理图，其中除去导管远端非治疗一侧以便最小减少与视网膜的接触。
具体实施方式
在AMD的视网膜下治疗中，使用玻璃体视网膜手术技术通过眼内套管、护套或探针促使将优选的但非唯一的暂时发射贝塔(beta)或其他离子辐射的放射源放置在视网膜下的空间中。其他非离子辐射源，例如光源或热源，如果情况需要也可以使用。
根据本发明的一个方面，提供应用放射源和传递装置的设备，所述传递装置允许该放射源在存储位置和治疗位置之间移动。当在存储(回撤)位置时，放射源被合适的材料，例如不锈钢和铅衬所包绕以便在操作和初始定位期间有效地保护外科大夫和患者。在治疗期间，将该放射源优选定位在专门设计的铂铱(Pt/Ir)或其他材料的顶部，以提供具有可控强度的放射的定向管理，同时防护并保护视网膜和周围其他非目标组织。
参考图1和2，该系统，通常用10指代，包括两个主要部件：可定位于源导线(RSW)12远端的放射源，和在所阐述的实施例中包括手柄16和传递套管18(也称为护套或探针)的传递装置14。另外，提供图7中所显示的定位系统20和图8和9中所阐述的方法以辅助该装置在眼内的精确定位。
在此放射源被广泛地定义，而非限于离子辐射、光辐射或热辐射。例如，放射源试图包括各种疗法的任何一种的治疗源，包括离子辐射。用于RSW12的放射源包括任何合适的放射源，包括诸如伽马(gamma)和贝塔(beta)辐射源的放射材料，X-线(例如小型X-线发生器)，和诸如激光或其他光源的非离子辐射源。或者，还可利用超声、热、冷冻消融(cryo-ablation)或微波源。
优选的，使用基本的贝塔发射材料，例如锶/钇90(Sr-90/Y-90)贝塔发射同位素。在放射性近似11mCi且位于距目标组织大约1-3mm(优选大约1-1.5mm)时，治疗时期相对较短，近似2-4分钟。该系统和方法提供用于在黄斑变性中发生脉络膜新血管形成的位置或其他治疗位置上进行放射的视网膜下传递。当应用离子辐射时，该系统优选以近似4到20GY/min的剂量率向目标位置提供放射；优选的目标剂量在近似10和40GY之间，对于新血管形成组织目标剂量最佳是近似26GY。
如图5中所阐述的，放射源的优选实施例包括根据传统技术掺有Sr-90/Y-90同位素的圆柱状铝嵌入物22并且优选地将其存于密封的不锈钢罐中。该罐包括了在其远端用盖26密封而在其近端用盖28密封的粒子管24。可将该不锈钢罐安装在由不锈钢(或其他材料)制成的实心或编制导线上形成用于推进放射源到治疗位置和将放射源从治疗位置撤回的RSW12。
如图5中所示，该放射源导线12优选地包括相对柔韧的远端或前导段30以及相对较硬的近端或手柄段32。具体的，前导段30的柔韧度是这样的使得允许无阻碍的机械输送穿过大约从4到8mm曲率半径的套管。RSW12具有近似190mm的整体长度，当将RSW12推进到治疗位置时，其从手柄16的后部提供10mm-15mm的导线突出(如图1和2中所见)，这样提供用于RSW的移除或重定位，如果必要的话。
前导段30的远端包括一个由盖36关闭的连接管34用于方便接合收纳放射性嵌入物22的罐。另外的连接管38用于将前导段30的近端结合到手柄段32的远端。在所阐述的实施例中，前导段30具有比手柄段更小的外径。这样，前导段30的近端携带额外长度的导管40以增大前导段30的外径从而与手柄段的外径匹配。手柄段32的近端还包括用于加固的管41的一段长度。除了放射性嵌入物之外，RSW12的各个部件优选由不锈钢制成并通过激光焊接结合在一起。也可以使用如已有技术中所公开的用于传递和/或撤回放射源的别的设备。例如，放射源可不固定到导线上，并且放射源在治疗和存储位置间的移动可通过气压制动或液压制动来实现。例如，见U.S.专利No.5,683,345，将其作为参考合并与此。
优选地但非必要地，手持传递装置14，以方便在使用期间对传递套管18的控制和定位。当不使用时，可将该放射源22，例如贝塔放射源，定位在防护存储手柄16中。该手柄16包括将其固定到RSW12近端部分的滑块机构，该滑块机构可在将放射源定位在套管18远端的治疗位置(图2)与将放射源22存储在手柄16中的回撤位置(图1)之间移动。当在存储位置时，该放射源优选地由不锈钢(内护罩)和铅(外护罩)的结合物进行防护。不锈钢护罩阻挡贝塔放射，而铅护罩减少二次放射(被认为是brehmmstrahlung)。也可使用其他合适的材料用于防护。
参考图1-3，手柄16包括用狭长的圆柱状容器42所收纳的多个部分，该圆柱状容器42在其近端由端帽44关闭，在其远端由中央冲头46关闭，并固定到套管18上。冲头46优选地由不锈钢制成并且用作当放射源在存储位置时放射源的内部放射护罩。冲头罩护部分的壁厚接近1.9mm。冲头46还携带铅外部护罩，用48指代，它的壁厚接近4.6mm。冲头和外部护罩48由固定到容器42远端的杯状元件50携带。
如上面所述，手柄16包括推进或定位机构(也被称为滑块机构)，通常用52指代，用于在存储和治疗位置间移动放射源22。滑块机构52包括可滑动地接纳在手柄16的圆柱状容器42内部的承载器元件54。承载器54包括中央孔，RSW12的手柄段32穿过该孔延伸，并且借助于固定螺丝56将RSW12固定到承载器54上。
为了在容器42的近端和远端之间移动承载器54，将穿过容器42内的缝隙60延伸的致动器销58固定到承载器54上，如所阐述的，缝隙60位于由弯曲的套管18所界定的平面内，这样具有与套管弧度相同的取向。缝隙60容许承载器54行进的近似60mm或更小的宽度并且在其远端和近端分别包括偏置端62、64，用于接纳致动器销58，这样，提供将放射源22置于治疗和存储位置的肯定性的视觉和触觉指示。承载器54的近端还包括通过螺钉68固定于此的盘簧66，用于当放射源处于回撤位置时将致动器销偏压在近偏置端64内的锁定状态。
参考图4，眼内探针18优选的是传递装置的主要部分，并且由坚硬的材料，例如不锈钢来制造。在所阐述的实施例中，探针或套管包括一个管腔并在远端密封以防止在放射源与患者或患者的体液之间产生接触。更具体的，探针远端包括当放射源处于治疗位置时放射源位于其中的内衬套70(最佳地见于图6)。内衬套70被配置成能提供所需的剂量过程(profile)，这将在下文中进行详细讨论。内衬套70被接纳在用于密封内衬套70并提供一些放射衰减的封盖衬套72内。
套管18的远端被弯曲或转弯成一角度以便于恰当地将放射源和治疗区域对准。探针18的顶部74优选地还具有圆楔形状以便于在该方法操作期间当视网膜被部分剥离并上升形成“气泡”(如通过在视网膜下注射盐水或其他流体)时，在视网膜下对远端进行定位。
顶部的治疗一侧包括模制机械加工或另外形成的能够直接管理放射的窗口76(由封盖衬套72密封)。通过在位于中央实体区域79处产生交叉的纵向和横向板条77将窗口76细分成四个更小的窗口，该实体区域79用作平稳过滤器以减少最接近放射源的组织所接收的来自放射源22的峰值放射量。结果，在治疗一侧被照射的组织接受更加一致的剂量。这个平稳效果显示在图11中，其描绘了作为来自放射源中心的射线和轴向距离的函数的剂量率(GY/min)。如图11中所看到的，峰值剂量率通常在放射源的中央是平稳的，随着离开中央处距离的增加而基本上线性地减少。在共同待审(co-pending)的PCT申请中，“Radioactive Radiation Source for Ophthalmic Brachytheraphy”，PCT/EP2004/012415，提交于2004年11月3日，讨论了平稳过滤器的各种结构，其作为参考合并与此。通常，平稳过滤器优选地包括悬挂于窗口中在最接近治疗位置的点上由所选厚度和/或材料的护罩来衰减或阻挡一部分从探针逃逸的放射。
在图7中显示了用于精确定位探针18的系统20的第一个实施例。定位系统20包括基座80和接触外延82，其用作参照元件并适于安装在护罩或探针18的眼外部分。将巩膜(眼睛的表面)用作尺寸参照点或面，将弹簧84定位在探针18上以提供在初始放置期间将接触外延80(当其被携带在基座82上时)靠在巩膜上的明确衔接。见图8和9。
为了装配到探针上，基座80具有大小正好符合探针18的缝隙86以便能将探针放在其上。接触外延82在其上也具有缝隙88以便在基座80的远端放置探针18。将接触外延82设计成坐在基座80上并通过摩擦衔接将其保持在适当的位置上。提供具有螺纹末端92的手柄90，该螺纹末端92被接纳在基座80上的互补螺纹孔94中。手柄90的螺纹末端92用作固定螺丝在初始放置后将基座80固定在探针18的适当位置上，这将在下文更详细地进行讨论。定位系统78可由任何合适的材料制成，但是优选的由乙缩醛制成。
参考图8，探针被初始定位，探针的顶部74以轻微接触被照射目标区域的方式触及视网膜或视网膜下的CNV组织。弹簧84将安装在基座80上的接触外延82推进到接触巩膜。接着手柄90反过来衔接住探针18，这样将基座80锁定在探针18的适当位置上。接着探针18从眼睛缩回。利用锁定在探针上适当位置的基座80，接着将隔离片96放置在基座80和接触外延82之间，该隔离片96也具有缝隙98从而能够将其放置在探针18上，如图9中所见，从而精确地设定治疗区域和探针顶部74之间的距离。
在实际操作中，隔离片96具有从大约0.5到3mm的厚度，优选的为1-1.5mm(1mm更佳)，以便能够在探针18的顶部74与目标区域之间产生同样距离的间隔。特定的间隔可随着眼部疾病的治疗、所用的放射源以及治疗区域的大小而改变。对于如以前所描述的使用贝塔放射源治疗与黄斑变性有关的新血管形成组织，1-2mm的间隔(优选为1-1.5mm)是所希望的间隔。在放射传递期间，接触外延抵靠在巩膜上，阻止或防止传递装置在眼中其他的轴向移动。
或者，通过使用眼内超声或多普勒来测量套管远端与目标组织之间的距离能够促进对探针顶部的定位。在这种情况下，套管远端可包括超声或多普勒换能器(与读取装置通信)以便传送并接收超声或多普勒波。对由此而产生的数据进行实时分析，并且在光学读取或指示器上呈现所计算的距离测量值。以相似的方式，光学干涉量度装置和技术能够用来测量套管顶部与目标组织之间的距离。
保证探针顶部与目标位置合适的间隔的结构可以有其他的形式。例如，如图12所示，探针18的顶部可包括一个或多个气囊100，其在气泡中可膨胀将探针顶部定位在视网膜(R)下以便确保视网膜和治疗区域之间的探针顶部的隔离。另外，或或者，探针18的远端101可关于探针的轴成一角度，当放射源处于治疗位置时可定位于此。(再次如图12所示-也可见于图15和17)。成角度的远端101确保在放射源和目标组织之间维持预定的最小距离。
在第二种替代形式中，如图13中所示，预制的导线或导线族102从探针内的管腔104中延伸到合适的空间或当探针顶部伸出管腔时将探针顶部从治疗区域推开。图14中所示，还可选的是，当将探针放置在治疗位置时使用穿过探针内管腔104的可回撤的导线筐。更进一步可选择的是将光纤固定到延伸超过远端一定量对应所要间隔的探针上。当光纤接触到目标组织时，光纤变暗，这样能提醒外科医生所需的间隔。
通过标准的玻璃体切割和视网膜剥离技术实现根据本发明的视网膜下眼内近程治疗的基本过程，其基本步骤如下。在治疗之前，外科医生使用视网膜血管标记确认目标组织的位置并鉴别巩膜切口入口点的优选位置(即，颞颥、鼻等)以便限制在治疗期间小凹的暴露。当将放射源推进到治疗位置时，外科医生还要确认将放射源适当地定位在探针上。用于测试放射源适当定位的装置及其使用的方法公开于共同待审的PCT申请，“Test Device forTesting Positioning of aRadioactive Source and Method of Using Same”，PCT/EP2004/012416，提交于2004年11月3日，其作为参考合并于此。
接着依照标准玻璃体切割程序对患者进行准备。具体的，患者的瞳孔被扩大并且将患者仰面定位在手术台上。在建立了适当的心脏和呼吸监视以及引入适当的麻醉后，用例如眼球后或眼球周围麻醉对眼睛进行麻醉。
然后，进入治疗区域。放置诊视检以固定眼睑，并且手术首先在待治疗眼睛的颞颥上、鼻上和颞颥下的象限内进行结膜切口。在距颞颥下象限内的手术缘近似3到4mm进行巩膜切口，并且将输注套管插入到玻璃体腔中。在确信输注套管正确定位后，打开输注线并在距鼻上象限内的手术开始之前所确定位置中的手术缘3到4mm处产生第二和第三巩膜切口。对用于玻璃体视网膜手术的合适的透镜进行定位并执行玻璃体切割，使用标准的内照明器对玻璃体腔进行照明。
然后，定位治疗探针。在这一操作的最后，定位系统20的弹簧84小心地滑过探针18直到装置手柄16，并且将定位系统放置到没有隔离片元件96的探针柄上，见图8。巩膜切口延伸到近似1.3mm的长度，并且将传递探针穿过巩膜切口插入到玻璃体腔中。
在显微镜观察下，外科医生将探针的顶部直接放在黄斑上。具体的，当直接将探针中央标记(在探针顶部指示放射源中心的标志)保持在CNV综合症的中心处时，通过轻轻触及视网膜组织来定位探针。当外科医生将该探针稳定地保持在这一位置时，将没有隔离片96的定位系统(基座80和接触外延82)固定在传递探针的外面部分直到接触巩膜从而在探针通过紧固手柄接触视网膜时鉴别探针精确的定位，并将套管从玻璃体腔中去除。接着将隔离片96放置在定位系统基座80和接触外延82之间，如图9中所示。
通过在黄斑区域使用视网膜下输液针产生局部视网膜剥离(“气泡”)，气泡包括脉络膜新生血管的区域。在气泡的颞颥边界上产生新的视网膜切口，利用距离小凹不到4mm处产生新的切口以减少周围视网膜流泪的风险。为了容纳探针，视网膜切口在直径上近似1.3mm。接着将传递装置探针18再次插入到玻璃体腔中并通第二视网膜切口进入到视网膜下的空间，如图10中所见。利用定位系统触及巩膜可直接将探针的远端定位到CNV综合症的中心上，这样确保探针的顶部在目标区域上方约1.5mm的距离。
然后，将放射剂量传递给目标组织。在这一操作的最后，通过将滑块机构推向探针的顶部来推进放射源。一旦放射源被推进，通过将销定位在锁销62上来锁定源导线。在合适的治疗时间之后，撤回滑块机构以便把放射源带回到存储和锁定位置。在确保放射源已经被完全撤回到其存储位置上之后，将传递探针从气泡中去除并从眼睛中退出。
在去除探针之后，接着将视网膜在手术中再次附着，并执行完全液-气交换，导致空气或气体填塞到玻璃体腔中。如果必要的话，通过例如激光凝固来关闭视网膜切口，而上巩膜切口用眼科用缝线关闭。关闭颞下巩膜切口，并用合适的眼科缝线缝合结膜。接着在结膜下的空间内给予抗生素和类固醇的混合物。
在另一种方法中，通过将放射衰减流体引入到利用升高视网膜离开CNV时所产生的气泡中在治疗期间防护和保护视网膜和其他非目标组织。该流体由盐水或具有更高衰减系数的流体，例如造影剂构成。在将放射应用到视网膜外层和巩膜外层期间，使用放射衰减流体以保护非目标组织也是有利的。在这种情况下，仅将放射衰减流体引入到眼睛的内部而非视网膜下的空间。
在操作过程期间维持气泡的形状也是重要的，以便使损坏光感受体的势能减到最小。值得思考的是可用几种不同的方式维持气泡的形状。例如，通过将高粘性物质注射到由气泡所产生的视网膜下的空间来维持气泡的形状。由于物质的高粘性，减少了其流过视网膜切口的能力。在治疗之后，使用标准玻璃体切割装置去除该高粘性物质。一种合适的高稠密物质是由Pharmacia公司出售的眼科使用的透明质酸钠，商标为HEALON。带有在治疗期间具有高初始粘性，此后具有低粘性的可变粘性物质会进一步方便在操作结束后将该物质从视网膜下的空间中去除。其粘性通过实施稀释剂(例如水)、化学制剂(用于调节ph值)、温度装料剂或由于光线提供的能量、光学反应等而减小的凝胶物质也将是合适的。
用于维持气泡形状的其他方法包括将密封物质(例如HEALON)应用到视网膜切口和从此插入的探针/套管，通过阻断探针和视网膜切口间流体的溢出来防止气泡发生萎缩。借助于与套管18连接的开口管腔108也可利用很小的正压力将膨胀剂，例如盐水，不断地引入到视网膜下的空间中(图15、16)。而且，套管的远端可设有一气囊(图12)，该气囊能在将套管远端引入到气泡后膨胀以支撑气泡并防止气泡萎缩或塌陷。
如果套管具有低摩擦表面，则也能使通过探针损坏光感受体的势能减到最小。这可通过用润滑剂涂覆探针或者其他涂层，例如聚四氟乙烯或电解碳来设置，或者将套管设置为通过如电抛光的高抛光表面。可选的，如图17中所示，可减少探针的背侧110(即，非治疗侧)以减轻探针与光感受体的接触程度。
防止或减少从视网膜流出的血进入视网膜下的空间并且从视网膜下空间去除残留的血液对于保护光感受体也是很重要的。在这一点上，可烧灼由所执行视网膜切割以产生气泡的切口范围来防止或减少视网膜出血。通过透热电热、冷冻粘结或者应用激光或RF能量，使用已知的用于在视网膜剥离的情况下将视网膜再附着到视网膜色素上皮细胞上的仪器和方法可实现这种烧结。
额外的，或者可替代的，借助于与治疗装置相连的分离管腔也可将诸如抗血友病因子VIII(重组体)(作为Kogenate可从BayerHealthcare处获得)、氨基己酸(作为Amicar可从Immunex处获得)以及醋酸去氨加压素(作为Octostim可从Rhone Poulanc Rorer处获得)的血液凝结剂注射到视网膜下的空间中以减少出血，如图15、16中所示。该促凝剂还可通过同一管腔去除。也可使用将铁结合物质(诸如脱辅基转铁蛋白)注射到血液中以便于从视网膜下的空间中去除血液并防止其氧化。
在已经照射CNV后，可将抗增生药物(抗血管内皮生长因子或抗VEGF制剂，例如哌加他尼钠(pegaptanib sodium))注射到视网膜下的空间以防止并/或减少CNV的进一步生长。
已经观察到含氧量低的细胞似乎比健康的细胞能更好的从放射中恢复。这样，人们相信在放射治疗期间减少非目标组织的视网膜血供应量以便于促进这些组织在照射后的恢复将会是有益的。在这一操作的最后，建议探针的顶部包括一个可膨胀的气囊，当其膨胀时该气囊引起对视网膜的压迫以减少流到那里的血流，穿过该气囊可执行放射治疗。可选的，建议用防辐射材料做成的可展开面罩保护非目标组织，该面罩可展开并放置在非目标组织上，而只暴露目标组织。所述材料可由探针18的顶部或由分离装置携带并且在形成气泡之后将其展开。如果需要的话这种材料可以是可生物降解的。
如上所述的视网膜下的操作，虽然被认为在治疗AMD上是有效的，但是需要眼外科医生很高程度的技能来产生气泡并将治疗套管定位在视网膜下的区域。相应的，也可将本发明的传递装置用在放射的眼内、视网膜外层应用的方法中，其中没有气泡产生。
视网膜外层方法的操作基本上比视网膜下的操作更容易。通过巩膜切开使得眼内进入变的容易。没有视网膜剥离或无需产生气泡。通过所描述的任何定位系统可实现探针的精确放置。也可使用本领域中已知的超声或多普勒技术。还可使用其他的机械方法，例如在将探针适当定位时将平衡光纤或“触须(whisker)”放在探针的尖端。可选的，还可使用可膨胀气囊，当其膨胀时，将探针与目标组织隔离出所需的距离。
在另一个替换形式中，可将能进行远程质询的微型放射传感器放在视网膜表面，并且基于由该传感器所测量的放射水平确定探针尖端和视网膜表面间的距离。如果使用多个(例如，3个)传感器，所测的放射强度的三角测量将提供位置的精确测定。如果将至少三个微型事件计数器或传感器定位在与目标组织等距离的视网膜周围的阵列上，可分析由每个点所测量的事件强度/频率并接着进行比较。接着在放射施行的开始通过众所周知的三维三角计算确定放射源的位置。可将事件计数器/传感器或者放在眼内、眼后或者如果放射源产生足够用于外部测量的发射，甚至可放在眼睛的前表面。或者，放射源可在其顶部携带一个小的换能器，该换能器能发射由上述定位的接收器接受的“脉冲信号(ping)”。还可使用诸如光或RF的其他信令/接受系统。作为其他的方法，布置在该装置顶部的永磁铁能够在适当的传感器中产生可测量的足够的伽伐尼效果，特别是在视网膜外层应用中，在此对装置大小的约束更不重要。数字化封闭信号将提供改进的速度和精度。
将会理解的是已经描述过的本发明实施例和方法是对本发明原理应用的解释。在不脱离本发明实质精神和范围下本领域的技术人员可做出各种改进，包括在此所单个公开和主张的特征的组合。

Claims (19)

1.一种用于局部地直接将放射传递到眼内目标组织的装置，包括：
放射源；
大小适于眼内插入到眼睛中并且具有近端和用于接纳放射源的远端的套管，该套管是液密的，以防止体液与放射源接触并且在其远端具有放射窗以便放射源接纳在其中时提供所需的放射剂量过程；和
外壳，固定于该外壳上的套管的近端被紧固，以便在回撤的近端位置与套管远端处的治疗位置间移动放射源，该外壳包括有效地连接到所述放射源的推进机构，该推进机构是可移动的，以便在回撤位置和治疗位置间移动放射源。
2.根据权利要求1的放射传递装置，其中，所述外壳包括用于在回撤位置上罩护放射源的罩护区。
3.根据权利要求1的放射传递装置，其中，所述外壳为放射源的回撤和治疗位置提供肯定性的视觉指示。
4.根据权利要求1的放射传递装置，其中，推进机构可锁定在回撤位置上。
5.根据权利要求1的放射传递装置，其中，所述外壳包括具有穿过其表面的第一和第二端部的狭长的缝隙，并且穿过该缝隙能够操纵所述推进机构，从而放射源能在回撤位置和治疗位置间移动。
6.根据权利要求1的放射传递装置，其中，所述放射源发射离子辐射。
7.根据权利要求1的放射传递装置，其中，放射源的远端足够的柔韧以允许穿过大约4到8mm曲率半径的套管进行无阻碍的机械输送。
8.一种具有远端和近端的用于局部地将放射传递到目标组织的放射源导线，包括：
相对坚硬的近端部分；
连接到所述近端部分的相对柔韧的远端部分；和
固定到所述源导线远端的放射源。
9.根据权利要求8的放射源导线，其中，所述远端部分足够的柔韧以允许穿过大约4到8mm曲率半径的套管进行无阻碍的机械输送。
10.根据权利要求8的放射源导线，其中，近端和远端部分包括：在其间具有接头的钢编织导线，以及用于加强近端部分到远端部分的连接的衬套。
11.根据权利要求1的放射传递装置，其中，所述放射源是具有放射性的，并且所述装置还包括连接到所述放射源的源传递导线，其中所述源传递导线具有近端和远端，且其中所述放射源导线的近端和远端包括：在其间具有接头的钢编织导线，以及用于加强近端到远端的连接的衬套。
12.根据权利要求8的放射源导线，其中所述放射源发射贝塔射线。
13.根据权利要求1的放射传递装置，其中所述放射源发射贝塔射线。
14.一种具有近端和远端的放射源导线，包括：
在远端的前导段，其具有足够的柔韧度，从而允许穿过大约4到8mm曲率半径的套管进行无阻碍的机械输送；
在近端的手柄段，其具有大于前导段的硬度；
用于将前导段固定到手柄段并通过焊接固定于前导段和手柄段的管状衬套；
放射源，包括保持着固定于前导段的远端的放射性种子的罐；
在罐和前导段的连接处用于将罐固定到前导段的加强衬套；和
在手柄段近端的加强管。
15.根据权利要求1的放射传递装置，其中，所述套管包括具有至少一个连接到所述外壳的管腔的管状元件，其远端包括用液密的密封物盖住窗口的盖子。
16.根据权利要求15的放射传递装置，其中，窗口顶部包括铂-铱材料。
17.根据权利要求1的装置，还包括：与所述套管相连的分离的管腔，其具有邻近套管远端的开口；具有远端的导线，其滑动地接纳在所述管腔中；以及在所述导线远端的可扩张结构，当导线的远端离开管腔的开口时，所述结构扩张。
18.根据权利要求1的装置，其中，所述套管还包括至少一个位于其远端的可膨胀气囊，以及用于选择性地使气囊膨胀和萎缩的分离的管腔。
19.根据权利要求1的装置，其中，所述套管还包括在所述套管远端具有开口的分离的管腔，通过该管腔能够选择性的输送或抽出流体。
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CN104000624B (zh) * 2014-04-24 2016-04-13 温州医科大学 一种贴于眼表用于眼轴测量的超声探头

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ATE488269T1 (de) 2010-12-15
AU2005214040B2 (en) 2011-03-31
US20100268013A1 (en) 2010-10-21
US20110004045A1 (en) 2011-01-06
EP2298412A1 (en) 2011-03-23
JP4602356B2 (ja) 2010-12-22
JP2007526034A (ja) 2007-09-13
US7744520B2 (en) 2010-06-29
WO2005079915A1 (en) 2005-09-01
EP1720608B1 (en) 2010-11-17
BRPI0507690A (pt) 2007-07-24
CA2554961A1 (en) 2005-09-01
DE602005024771D1 (de) 2010-12-30
US7803102B2 (en) 2010-09-28
CA2554961C (en) 2013-04-23
US20070055089A1 (en) 2007-03-08
US7951060B2 (en) 2011-05-31
EP1720608A2 (en) 2006-11-15
US20050277802A1 (en) 2005-12-15
WO2005079294A2 (en) 2005-09-01
US8365721B2 (en) 2013-02-05
EP1720608A4 (en) 2008-03-26
AU2005214040A1 (en) 2005-09-01
CN101005873B (zh) 2010-07-21

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