CN102481171A - 用于输送眼部植入物的单人操作装置 - Google Patents

用于输送眼部植入物的单人操作装置 Download PDF

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CN102481171A
CN102481171A CN2010800302374A CN201080030237A CN102481171A CN 102481171 A CN102481171 A CN 102481171A CN 2010800302374 A CN2010800302374 A CN 2010800302374A CN 201080030237 A CN201080030237 A CN 201080030237A CN 102481171 A CN102481171 A CN 102481171A
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ocular implants
implant
eyes
sleeve pipe
induction system
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CN102481171B (zh
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J·沃德勒
A·T·施伯尔
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Alcon Inc
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Ivantis Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F9/00—Methods 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
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F9/00—Methods 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
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts

Abstract

本发明提供了一种具有多个特征的眼部植入物输送系统。在一些实施方式中，该输送系统包括旋转机构和推进机构，旋转机构构造成用来旋转和定向所述系统的套管，推进机构构造成使眼部植入物通过所述输送系统前进和后退并进入患者眼睛内。在一些实施方式中，所述套管定尺寸和构造成插入眼睛的施累姆氏管内。所述眼部植入物构造成在所述套管旋转时保持其在所述输送系统内的取向。在一些实施方式中，所述眼部植入物在其前进超过所述输送系统的远侧末端时自动地与所述输送系统断开。本发明还提供了植入眼部植入物的方法。

Description

用于输送眼部植入物的单人操作装置
相关申请的交叉引用
根据35U.S.C.119，本申请要求于2009年7月9日提交的名称为“Single Operator Device for Delivering an Ocular Implant”的美国临时专利申请No.61/224,156的权益。该申请的全部内容通过引用结合在本文中。
通过引用的结合
本说明书中提到的所有出版物和专利申请均通过引用结合在本文中，其效力与单独地、明确地声明将每一出版物或专利申请通过引用结合在本文中相同。
技术领域
本发明总体上涉及植入在眼睛内的装置和用于这种装置的输送系统。具体地说，本发明涉及用于帮助流体从眼睛的一个区域内转移到眼睛的另一区域的装置的输送系统。
背景技术
根据美国国家卫生研究院(United States National Institutes ofHealth，NIH)的国家眼科研究所(National Eye Institute，NEI)的规划报告，青光眼是目前全球范围内导致不可逆性失明的主要原因，并且是世界上导致失明的仅次于白内障的第二大主要原因。因此，NEI的规划报告认为“必须重视并继续投入大量的资源以确定这种疾病的病理生理机制”。青光眼研究已经发现眼内高压与青光眼之间存在较强的联系。因此，眼保健专家通过使用已知为眼压计的装置测量患者的眼内压力来例行地筛查出青光眼患者。许多现代的眼压计通过向眼睛的外表面吹一股突然的空气进行所述测量。
眼睛可以理解为充满流体的球体。眼睛内有两种类型的流体，晶状体后面的腔内充满被称为玻璃体的粘性流体，晶状体前面的腔内充满被称为水状体的流体。当人们观看物体时，他或她同时通过玻璃体和水状体观看该物体。
当人们观看物体时，他或她还通过眼镜的角膜和晶状体观看该物体。为保持透明，角膜和晶状体没有血管。因此，没有血液流经角膜和晶状体来向这些组织提供营养和从这些组织去除废物。相反，这些功能由水状体执行。水状体连续流经眼睛，向没有血管的眼睛部分(例如，角膜和晶状体)提供营养。水状体的流动还从这些组织处除去废物。
水状体由被称为睫状体的器官产生。睫状体包括连续地分泌水状体的上皮细胞。在健康的眼睛内，当睫状体的上皮细胞分泌出新的水状体时，水状体流经过小梁网流出眼睛前房并流进施累姆氏管(Schlemm’s canal)。这些多余的水状体从施累姆氏管进入静脉血液流并由静脉血携带离开眼睛。
当眼睛的自然排出机能不能正常工作时，眼睛内的压力开始上升。研究者已经提出理论认为，眼内长期高压将损害从眼睛向大脑传递感觉信息的视神经。这种视神经的损害导致周围视觉的损失。随着青光眼的发展，越来越多的视觉区域损失，直到患者完全失明。
除了药物治疗，对青光眼还有各种外科手术治疗。例如，植入分流管从而将水状体从前房引导至眼外静脉(Lee和Scheppens，“Aqueous-venous shunt and intraocular pressure”，InvestigativeOphthalmology(1966年2月))。其它早期青光眼治疗植入物从前房通向结膜下的泡体(例如，US4,968,296和US5,180,362)。还有一些是从前房通向施累姆氏管内部某处的分流管(Spiegel等人，“Schlemm’s canalimplant：a new method to lower intraocular pressure in patients withPOAG？”，Ophthalmic Surgery and Lasers(1999年6月)；US6,450,984；US6,450,984)。例如在US2007/0191863和US2007/0010827中描述了用于一些青光眼植入物的输送和部署的系统。例如在US2007/0073275和US2006/0149194中描述了用于进入施累姆氏管的外科手术装置。
发明内容
在一个实施方式中，一种眼部植入物输送系统包括：壳体；联接至所述壳体的套管，所述套管定尺寸和构造成用来插入人类眼睛的施累姆氏管内；布置在所述壳体上的输送机构，该输送机构构造成用来使眼部植入物在所述套管内前进和后退；以及布置在所述壳体上的定向机构，该定向机构构造成用来控制所述套管的旋转，其中在所述套管旋转时所述眼部植入物维持其相对于所述套管的取向。
在一些实施方式中，所述眼部植入物输送系统还包括可滑动地布置在所述套管内并联接至所述输送机构的推管。所述眼部植入物可以联接至所述推管的远侧部分。在一些实施方式中，所述植入物的互锁指状部联接至所述推管上的指状部接口。
在另一个实施方式中，所述眼部植入物输入系统还包括布置在所述眼部植入物内的芯轴。所述芯轴或芯线可以构造成与所述眼部植入物的内径对准，以防止所述植入物的任何尖锐边缘或孔在植入过程中与组织接合。
在所述输送系统的一个实施方式中，所述输送机构和所述定向机构在所述壳体上的相对位置允许利用一只手控制所述眼部植入物的前进和后退以及所述套管的旋转。
在另一个实施方式中，所述眼部植入物构造成在其前进超过所述套管的远侧末端时自动地从所述眼部植入物输送系统断开。在一些实施方式中，所述眼部植入物预先偏压以采取扩张构型。当所述植入物前进超过所述套管的末端时，所述植入物能够扩张以与所述输送系统断开(例如与推管断开)。
在一个实施方式中，所述眼部植入物输送系统还包括具有锁定键的芯线，所述锁定键构造成用来与所述眼部植入物接合。
提供了一种将植入物输送到患者眼睛内的方法，包括：将一输送装置插入所述眼睛内；使所述植入物通过所述输送装置前进到所述眼睛内；以及使所述植入物扩张以使所述植入物从所述输送装置断开。
在一些实施方式中，所述插入步骤还包括将一套管插入眼睛的施累姆氏管内。
所述方法的另一个实施方式还包括利用一定向机构调节所述套管的取向以使所述套管与施累姆氏管的曲率对准的步骤。
在该方法的一些实施方式中，用使用者的单只手实现所述前进步骤和调节步骤。
前进步骤可以还包括利用布置在所述输送装置上的轮使所述植入物前进。在另一个实施方式中，前进步骤还包括使所述植入物经过所述输送装置的远侧末端前进到眼睛内。在另一实施方式中，所述植入物在其前进经过所述输送装置的远侧末端时自动地扩张以使其自身从所述输送装置断开。
在一些实施方式中，扩张步骤还包括使所述植入物扩张以使所述植入物的互锁部件与所述输送装置的互锁部件断开。所述输送装置的互锁部件例如可以是一推管的互锁部件。在另一实施方式中，所述输送装置的互锁部件可以是一芯线的互锁部件。
在该方法的一些实施方式中，前进步骤还包括利用推管使所述植入物前进到所述眼睛内。
作为替换，前进步骤可以还利用芯线使所述植入物前进到所述眼睛内。在一个实施方式中，所述方法可还包括在使所述植入物扩张之后从所述植入物移除所述芯线的步骤。
在另一个实施方式中，将所述植入物插入在脉络膜周隙内。
提供了另一种将植入物植入眼睛的施累姆氏管内的方法，包括：旋转一输送装置的定向机构以将一套管与施累姆氏管对准；使所述套管前进通过角膜的切口并进入所述眼睛；利用所述套管刺穿施累姆氏管；利用第一只手控制所述输送系统的推进机构以使所述眼部植入物从所述输送系统前进到施累姆氏管内；在所述控制步骤过程中利用第二只手保持前房角镜，以使所述眼部植入物到施累姆氏管内的植入可视化；以及当所述眼部植入物前进超过所述套管的远侧末端时将所述眼部植入物自动地从所述输送系统断开。
在一些实施方式中，所述方法还包括使所述眼部植入物在所述眼睛内扩张以使所述眼部植入物从所述输送系统断开。
附图说明
在随后的权利要求中详细地阐述本发明的新颖特征。通过参照如下阐述了利用本发明的原理的示例性实施方式的详细描述和附图将能更好地理解本发明的特征和优点，在附图中：
图1是人眼睛的示意图。
图2是示出有施累姆氏管的眼睛的近视图。
图3是用于将眼部植入物植入在眼睛中的输送装置。
图4-5是输送装置的一部分的近视图。
图6是输送装置的剖视图。
图7是输送装置的近视剖视图。
图8是示出输送装置的内部特征的分解图。
图9-11是输送装置的一些内部特征的近视图。
图12-13是输送装置的剖视图。
图14是输送装置的一部分的近视剖视图。
图15-17示出了从输送装置分离眼部植入物的一个实施方式。
图18-19示出了从输送装置分离眼部植入物的另一个实施方式。
图20-22示出了在患者眼睛中植入眼部装置的方法。
具体实施方式
如下详细描述应参照附图来阅读，在附图中，不同附图中类似的元件以相同的附图标记表示。不一定按照比例绘制的附图示出的是示例性的实施方式，并不意在限制本发明的范围。对于特定元件给出了结构、材料、尺寸和制造过程的例子。所有其它元件均为本发明领域内技术人员所已知。本领域的技术人员会认识到所提供的许多例子都有可利用的合适的替代方案。
这里描述的装置、系统和方法可能有助于青光眼的治疗。这里描述的可植入眼部装置可以被插入在眼睛的施累姆氏管、小梁网、脉络膜周隙和/或前房内，以促进水状体从前房流出。当位于眼睛内的适当位置时，可植入装置可以支承小梁网组织和/或施累姆氏管组织，并且可以改善前房和施累姆氏管之间(经由小梁网)、沿着施累姆氏管和/或脉络膜周隙的凹窝或隔室之间的连通。
这里描述的系统可以包括用于将可植入装置输送到眼睛的施累姆氏管、小梁网、脉络膜周隙和/或前房内的输送装置。这里描述的输送装置可以被构造成由一个内科医生或外科医生利用单个手指的运动精确且可预测地使可植入装置前进、后退和部署可植入装置。该输送装置可以选择性地接合可植入装置，从而在植入在眼睛中之前允许可植入装置前进和后退。这里描述的输送装置还可以被构造成旋转输送装置的弯曲部以眼睛虹膜的曲率对准。
图1是示出了眼睛20的一部分的示意图。在图1中可见眼睛的角膜22的外表面的映像。角膜22包围眼睛的前房24。通过角膜和前房可见眼睛的虹膜26。前房24充满有助于维持角膜的大致半球形形状的水状体。从前房24排出水状体的结构包括施累姆氏管30和大量静脉血管28。
在图1中，可以看到施累姆氏管30环绕虹膜26。水状体离开前房24并通过流经小梁网32而进入施累姆氏管30。水状体通过流经称为收集通道40的多个出口而离开施累姆氏管30。在离开施累姆氏管30之后，水状体通过静脉血管20行进并被吸收在血液流中。
图2是在前图中示出的眼睛20的一部分的放大示意图。在图2中使用箭头表示在眼睛20中的水状体的流动。在图2中，流过小梁网32并进入施累姆氏管30内的水状体由多个横向流动箭头34代表。水状体沿着施累姆氏管的长度的流动使用多个轴向流动箭头36示出。
图3示出了单人操作输送装置100，其被构造成用于将眼部植入物输送到患者的眼睛内，例如输送到眼睛的施累姆氏管内、小梁网内、脉络膜周隙内和/或前房内。待植入的眼部植入物可以包括在美国申请No.11/860,318、No.11/943,289、No.12/236,254、No.12/398,847及美国临时专利申请No.61/033,746、No.61/120,222和No.61/120.295中描述的任何眼部植入物。
参照图3，输送装置100可以包括壳体102、可旋转套筒104、循迹轮106、套管108和端盖110。图3中所示的输送装置构造成利用一只手抓握，同时除了(借助于循迹轮106)提供对眼部植入物的前进、后退和部署的控制之外还(借助于可旋转套筒104)提供对套管的旋转和取向的控制，所有这些都是在利用同一只手抓握输送装置的同时进行的。通常，循迹轮是构造成用于眼部植入物的前进和后退的输送机构，而可旋转套筒是构造成用来控制套管的旋转和取向的定向机构。输送装置100的壳体——特别是壳体内的可动控制元件的相对位置——导致手指操作的控制元件相对于用手稳定的壳体的理想的人机工程学关系。该设计提供了一种允许使用者例如内科医生稳定并定向输送装置而同时允许中指或食指独立地移动并执行眼部植入物的植入的构造。这种单手操作使内科医生留出另一手用于其它之用，例如保持前房角镜。
图4-5示出了可旋转套筒104和套管108的近视图。在一些实施方式中，该套管可以具有屈曲或弯曲的远侧部分114，该远侧部分114构造成用来帮助将眼部植入物植入眼睛内，诸如施累姆氏管内。套管的弯曲的远侧部分可以具有预形成的弯度或曲率，该弯度或曲率定尺寸和构造成与施累姆氏管的自然曲率一致和被植入在施累姆氏管内。该套管还可以具有尖锐或斜切末端，例如用来切入和切穿组织。如图所示，套管可以安装至毂112。该毂可以以各种方式附装至可旋转套筒，诸如通过销116或通过粘合剂。通过将可旋转套筒104联接至套管108和毂112，可旋转套筒的旋转(例如由内科医生操作)能够改变套管相对于壳体102的取向。例如，图4示出了位于第一取向的套管，而图5示出了在可旋转套筒旋转之后位于第二取向的套管。可旋转套筒104还可以包括抓握特征，例如位于可旋转套筒上的凹槽(如图所示)、橡胶涂层或其它摩擦表面。
在眼部植入物的植入过程中，套管和虹膜之间必须正确对准，以确保使眼部植入物相对于该眼部植入物所要植入的眼睛中的施累姆氏管或其它解剖结构以正确轨迹前进。改变套管相对于壳体的取向可以调节输送装置100以适应个体解剖结构变化、个体内科医生握持位置偏好和右手/左手使用者。输送装置的构造方式使得在旋转过程中保持眼部植入物在输送装置内对准。所有元件都被锁定在一起，以确保植入物和套管作为单一体部旋转，且同时允许眼部植入物线性移动(即，前进和后退)。例如，在眼部植入物的一些实施方式中，植入物的某些特征例如植入物中的开口被构造成与具体的解剖结构例如施累姆氏管的收集通道对准。由于这里描述的输送装置保持眼部植入物与套管的预定曲率对准，因此内科医生能够确保眼部植入物在被输送至施累姆氏管之后的正确取向。
图6是输送装置100的剖视图，示出了装置的内部结构，包括循迹轮106、惰齿轮118和旋转齿条轮120。循迹轮106和惰齿轮118可旋转地安装至壳体102。循迹轮上的齿与惰齿轮118上的齿啮合，惰齿轮118上的齿又与旋转齿条轮120上的齿啮合，以使齿条轮在输送装置内向远侧和向近侧移动。惰齿轮118包含在所述装置中，从而循迹轮106在远侧方向上的旋转将导致齿条轮向远侧移动，而循迹轮在近侧方向上的旋转将导致齿条轮向近侧移动。另外，旋转齿条轮120被构造成与可旋转套筒104一起旋转，同时保持在旋转之前、旋转过程中和旋转之后在远侧和近侧方向上线性移动的能力。
图7是输送装置在可旋转套筒104附近的内部特征的近视图，所述内部特征包括毂112、销116、眼部植入物122、推管124和O型圈126。眼部植入物和推管可以是上面引用的美国专利申请和临时专利申请中描述的任意眼部植入物和推管。如图7所示，眼部植入物可以部分地定位在套管108中，并且可以抵靠输送装置中的推管124。O型圈可以向可旋转套筒提供张力和阻力，以用于在旋转过程中的能触知的反馈，并且能够防止套筒从期望取向移开。
图8-11是输送装置100的内部特征结构的分解图，这些内部特征结构包括壳体102、循迹轮106、套管108、端盖110、毂112、惰齿轮118、旋转齿条轮120、推管124、槽128、传送管130、互锁指状部连接器132、指状部接口134和芯线或芯轴136。如图8所示，传送管130连接至毂112，并且定尺寸成在其中可滑动地承载眼部植入物和推管124。传送管的近侧部分(如图9所示)可以包括六边形套筒，该六边形套筒定尺寸成用于装配在旋转齿条轮120的六角型通孔内(如图11中所示)。
如这里以及上面引用的申请中所描述的，推管124和眼部植入物可以定尺寸和被构造成在传送管130和套管内滑动。推管124可以具有与眼部植入物的直径对应的直径，从而推管的远侧运动可以推靠眼部植入物并使得眼部植入物在输送系统内向远侧运动而进入患者体内。
另外，输送装置还可以包括芯线136，该芯线定尺寸成用于在眼部植入物和推管124内滑动。参照图8和11，该芯线136能够联接至旋转齿条轮120。如在上面引用的申请中所描述的，在植入物的输送过程中，芯线可以定位于眼部植入物的内径内，以便阻止和防止在植入过程中植入物中的任何尖锐边缘或孔(例如植入物中的流体入口和出口的边缘)切割或损坏患者的组织。另外，芯线可以具有适合于在植入物插入到患者眼内时使施累姆氏管扩张的远侧半径。
如图10-11所示，芯线的近侧部分可包括适合于与推管的近侧部分上的互锁指状部132接合和相连的互锁指状部接口134。互锁指状部132可以预先偏压以采取扩张或向外的构型。例如，互锁指状部132可以由不锈钢或诸如镍钛诺之类的形状记忆合金形成。在一些实施方式中，互锁指状部接口和互锁指状部由具有相同直径的海波管(hypotube)切割成。当指状部诸如在传送管130内被压缩时，它们能够与互锁指状部接口接合以将推管和芯线连接在一起，并且允许推管和芯线随着旋转齿条轮向远侧和向近侧的移动而一起移动通过传送管130和输送系统。
图12-13示出了循迹轮106的旋转如何使得惰齿轮118、旋转齿条轮120、眼部植入物、推管124和芯线136运动，由此使得能够通过一个手指使植入物前进、释放植入物和使输送机构后退而进行一只手操作。在图12中，输送装置100被示出为处于眼部植入物被部署在患者体内之前，其中旋转齿条轮120定位于壳体102中的槽128的近侧。图13示出了输送装置被完全部署好的情形，其中旋转齿条轮定位于槽128的远侧并接触毂112。为了使旋转齿条轮120从图12中所示的近侧位置移动到图13中所示的远侧位置，可以向远侧转动循迹轮106(例如沿着如图13中的箭头所示的逆时针方向)，这使得惰齿轮118在近侧方向上旋转，这又使得旋转齿条轮120朝向毂112向远侧移动。类似地，可以通过在近侧方向上旋转循迹轮106而使旋转齿条轮返回到壳体102内的近侧位置。在另一实施方式中，可以将惰齿轮从输送装置中去除，这将导致循迹轮的远侧运动使齿条轮向近侧运动。
当旋转齿条轮120从图12中的近侧位置向远侧运动至图13中的远侧位置时，齿条轮使得推管124、芯线136和眼部植入物(未示出)在传送管130内向远侧移动。当齿条轮位于图13中所示的远侧位置时，眼部植入物被完全推出套管108并进入患者体内。在一些实施方式中，为了将植入物从套管中推出，齿轮无需充分前进至最远侧位置。
另外，当齿条轮位于最远侧位置时，推管124的互锁指状部132(图14中所示)和芯线136的互锁指状部接口134(图14中所示)定位于毂112中的开口138中，如图14所示。开口138可以具有比传送管130大的内径。传送管130可以终止于开口138处，这样当互锁指状部进入该开口并且不再受到传送管内壁的限制时，互锁指状部132可以自动地向外扩张而采取其预偏压构型，由此使推管124与芯线136的指状部接口134断开接合。随着芯线与推管分离，齿条轮的近侧运动(诸如通过沿着近侧方向旋转循迹轮)可以向近侧将芯线从推管和眼部植入物移除，由此将芯线从植入物移除而将植入物留在患者内。在芯线被移除时推管可以保留在最远侧位置以抵靠眼部植入物并保持植入物就位。
应理解的是，眼部植入物的前进和后退并不限于这里描述的循迹轮。例如，在一些实施方式中，为了使植入物前进和后退，壳体可以包括按钮和用于电驱动所述(跟踪)轮的马达。
图15-17示出了用于选择性地将眼部植入物122联接至输送装置100的推管124的装置和方法的实施方式。图15是定位于输送装置100的套管108内的推管124和眼部植入物122的俯视图。类似于上面描述的互锁指状部和互锁指状部接口，该推管和眼部植入物可以包括互锁部件140。例如推管可以包括互锁指状部，而眼部植入物可以包括互锁指状部接口，或者反之亦然。可以使用互锁形状的任何变型。图16是图15中所示的推管和眼部植入物的侧视图。图16示出了还包括狭缝或多个狭缝142的眼部植入物。眼部植入物可以预先偏压而采取扩张构型。当所述植入物诸如在上述的套管或传送管内被压缩时，互锁部件140将挤压植入物并使植入物与推管接合和锁定。然而，当眼部植入物被向远侧推动超过套管108的远侧末端时，如图17所示，植入物可以采取其预偏压构型，使得植入物沿着所述狭缝自动地扩张并从推管分离以被释放在患者内。植入物的扩张部分还提供了更大的开口，以防止当植入物位于患者体内时发生堵塞。
图18-19示出了输送系统100的替换实施方式，该输送系统100不包括推管，而是使用联接至芯线136的锁定键144来使眼部植入物前进、后退和输送到患者内。如图18所示，芯线136可以布置在眼部植入物122和输送系统100的套管108内。锁定键144可以布置在芯线上，并且可以与眼部植入物的窗口146接合。如上所述，在植入物不受限制时(例如当植入物不在套管内受到限制时)，该植入物可预先偏压而采取扩张构型。当植入物诸如在上述套管或传送管内被挤压时，锁定键144将与窗口146接合以将芯线连接至植入物。然而，当眼部植入物被向远侧推动超过套管108的远侧末端时，如图19所示，植入物可以采取其预偏压构型，从而使得植入物扩张并从芯线分离。
这里描述的输送装置被构造成使内科医生利用单手使眼部植入物前进和后退以及将植入物输送到患者的眼睛内。内科医生通常仅有一只手可用于执行植入操作，因为另一只手被用于同时保持和稳定前房角镜以使植入过程可视。内科医生在植入过程中通常使用他们的脚通过外科显微镜调节图像，使得用脚操作的系统不实用。
如上所述，可以利用循迹轮106来控制植入物的前进和后退，可以通过旋转可旋转套管104来改变套管、毂、植入物、推管和芯线的取向从而控制植入物在患者内的取向。当眼部植入物向远侧前进超过套管108的远侧末端时，植入物可以自动地扩张至预偏压构型，以将推管断开并保留在患者眼睛内的期望位置。如上所述，在将眼部植入物完全植入在患者之前，可能需要通过使旋转齿条轮沿着近侧方向退回而将芯线从植入物内移除。
图20-22示出了用于将眼部植入物输送到患者眼内的方法。眼部植入物可以被插入在施累姆氏管、小梁网、脉络膜周隙和/或前房内，以促进水状体从前房流出。水状体的该流出可以包括沿着施累姆氏管的轴向流动、从前房到施累姆氏管内的流动、经由与施累姆氏管连通的出口离开施累姆氏管的流动、或到脉络膜周隙内的流动。当被植入在眼睛内时，眼部植入物将支撑小梁网组织和施累姆氏管组织，并且将改善前房和施累姆氏管之间(经由小梁网)、沿着施累姆氏管的凹窝或隔室之间、或者前房和脉络膜周隙之间的连通。
图20是示出了脸一部分和眼睛20的视图。套管108延伸穿过眼睛20的角膜，使得套管108的远侧端部布置在眼睛的前房内。参照图20，应意识到，套管108的远侧末端定位于眼睛的小梁网和施累姆氏管32附近。如上文参照图3-7描述的，可通过旋转套筒来调节套管相对于眼睛的取向。
图21是示出了在前图中所示的眼睛20的一部分的另一放大图。在图21的实施方式中，套管108的远侧末端已经刺穿小梁网32。套管108的远侧末端还刺穿了施累姆氏管30的壁，并且套管108的远侧开口被布置成与施累姆氏管流体连通。在一些实施方式中，套管108是弯曲的，以实现基本沿切向进入施累姆氏管内。
图22是在前图中示出的眼睛20的另一视图。在图22的实施方式中，眼部植入物122已经前进通过套管并进入眼睛的施累姆氏管内。图22示出了布置在植入物122内的芯线124以及在套管108内抵靠眼部植入物的近侧部分的推管(未示出)，如上所述。眼部植入物可以利用这里描述的输送装置100前进通过输送系统并进入眼睛内，诸如通过旋转循迹轮106使推管、芯线和植入物前进通过输送系统并进入眼睛内，如以上参照图3、6和12-13所述的。
一旦植入物定位于施累姆氏管内(或另选地定位在脉络膜周隙内或眼睛的其它解剖结构内)，则可以使植入物前进超过套管的远侧部分以允许植入物与推管和芯线分离(如上所述并参照图14-19所示)。芯线也可以被构造成自动地从推管分离，并且随后可以使芯线从眼部植入物退回，同时允许推管抵靠植入物以将植入物保持就位。一旦植入物位于患者眼睛内，则可以将输送系统从患者移除而仅将植入物留下。
在另一个不利用推管的实施方式中，如上所述并参照图18-19，植入物可以前进超过套管的远侧部分以允许植入物从芯线的锁定键分离。然后可以将芯线从眼部植入物移除。一旦植入物位于患者的眼睛内，则可以将输送系统从患者移除而仅将植入物留下。
对于与本发明有关的其它细节，可以采取相关技术领域技术人员水平内的材料和制造技术。就通常或逻辑上采用的其它行为来说，对于本发明的基于方法的方面，这同样可以适用。而且可以想到，所描述的本发明变型的任何可选特征都可以独立地或者与这里描述的特征中的一个或多个相组合地进行阐述并要求保护。同样，对单数项目的描述包括存在多个相同项目的可能。更具体地说，如这里以及权利要求中所使用的，单数形式“一”、“一个”、“所述”和“该”包括复数描述，除非上下文明确规定。还要注意，权利要求可能撰写成排除了任何可选元素。同样，该声明旨在用作与权利要求元素的叙述相关地使用“唯一”、“仅”等排除性术语或使用“否定”限定的在先基础。除非这里另有定义，这里使用的所有科技术语的含义与本发明所属领域的技术人员所通常理解的含义相同。本发明的范围不受主题说明书的限制，而是仅由所采用的权利要求项的一般含义来限定。

Claims (25)

1.一种眼部植入物输送系统，包括：
壳体；
联接至所述壳体的套管，所述套管定尺寸和构造成用来插入人类眼睛的施累姆氏管内；
布置在所述壳体上的输送机构，该输送机构构造成用来使眼部植入物在所述套管内前进和后退；以及
布置在所述壳体上的定向机构，该定向机构构造成用来控制所述套管的旋转，其中当所述套管旋转时，所述眼部植入物维持该眼部植入物相对于所述套管的取向。
2.根据权利要求1所述的眼部植入物输送系统，还包括可滑动地布置在所述套管内并联接至所述输送机构的推管。
3.根据权利要求2所述的眼部植入物输送系统，其中，所述眼部植入物联接至所述推管的远侧部分。
4.根据权利要求1所述的眼部植入物输送系统，其中，所述输送机构和所述定向机构在所述壳体上的相对位置允许利用一只手控制所述眼部植入物的前进和后退以及所述套管的旋转。
5.根据权利要求1所述的眼部植入物输送系统，还包括布置在所述眼部植入物内的芯轴。
6.根据权利要求1所述的眼部植入物输送系统，其中，所述眼部植入物构造成在其前进超过所述套管的远侧末端时自动地从所述眼部植入物输送系统断开。
7.根据权利要求6所述的眼部植入物输送系统，其中，所述眼部植入物预先偏压而采取扩张构型。
8.根据权利要求1所述的眼部植入物输送系统，还包括具有锁定键的芯线，所述锁定键构造成用来与所述眼部植入物接合。
9.根据权利要求8所述的眼部植入物输送系统，其中，所述眼部植入物预先偏压而采取扩张构型。
10.一种将植入物输送到患者眼睛内的方法，包括：
将一输送装置插入所述眼睛内；
通过所述输送装置使所述植入物前进到所述眼睛内；以及
使所述植入物扩张以使所述植入物从所述输送装置断开。
11.根据权利要求10所述的方法，其中，所述插入步骤还包括将一套管插入眼睛的施累姆氏管内。
12.根据权利要求11所述的方法，还包括调节所述套管相对于一定向机构的取向以使所述套管与施累姆氏管的曲率对准的步骤。
13.根据权利要求12所述的方法，其中，用使用者的单只手实现所述前进步骤和调节步骤。
14.根据权利要求10所述的方法，其中，所述前进步骤还包括利用布置在所述输送装置上的轮使所述植入物前进。
15.根据权利要求10所述的方法，其中，所述前进步骤还包括使所述植入物经过所述输送装置的远侧末端前进到眼睛内。
16.根据权利要求15所述的方法，其中，所述植入物在其前进经过所述输送装置的远侧末端时自动地扩张以使其自身从所述输送装置断开。
17.根据权利要求10所述的方法，其中，所述扩张步骤还包括使所述植入物扩张以使所述植入物的互锁部件与所述输送装置的互锁部件断开。
18.根据权利要求17所述的方法，其中，所述输送装置的互锁部件是一推管的互锁部件。
19.根据权利要求17所述的方法，其中，所述输送装置的互锁部件是一芯线的互锁部件。
20.根据权利要求10所述的方法，其中，所述前进步骤还包括利用一推管使所述植入物前进到所述眼睛内。
21.根据权利要求10所述的方法，其中，所述前进步骤还包括利用一芯线使所述植入物前进到所述眼睛内。
22.根据权利要求21所述的方法，还包括在使所述植入物扩张之后从所述植入物移除所述芯线。
23.根据权利要求10所述的方法，其中，将所述植入物插入在脉络膜周隙内。
24.一种将眼部植入物植入眼睛的施累姆氏管内的方法，包括：
旋转一输送装置的定向机构以将一套管与施累姆氏管对准；
使所述套管前进通过角膜的切口并进入所述眼睛；
利用所述套管刺穿施累姆氏管；
利用第一只手控制所述输送系统的推进机构以使所述眼部植入物从所述输送系统前进到施累姆氏管内；
在所述控制步骤过程中利用第二只手保持前房角镜，以使所述眼部植入物到施累姆氏管内的植入可视化；以及
当所述眼部植入物前进超过所述套管的远侧末端时使所述眼部植入物自动地从所述输送系统断开。
25.根据权利要求24所述的方法，还包括使所述眼部植入物在所述眼睛内扩张以使所述眼部植入物从所述输送系统断开。
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US10492949B2 (en) 2019-12-03
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US9693899B2 (en) 2017-07-04
US20200060876A1 (en) 2020-02-27
US11918514B2 (en) 2024-03-05
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US20220096271A1 (en) 2022-03-31
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