CN104758118B - 用于进入眼睛的装置 - Google Patents
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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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
- A61F9/00727—Apparatus for retinal reattachment
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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
- A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/48—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for varying, regulating, indicating or limiting injection pressure
- A61M5/486—Indicating injection pressure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/06—Head
- A61M2210/0612—Eyes
Abstract
本发明提供经由微创的结膜通路进入眼睛中的脉络膜上腔或视网膜下腔的装置。可也在部分切开术之后（例如在眼睛外巩膜层的切开术之后）使用该装置，并且在切开术中使用该装置以进入脉络膜上腔或视网膜下腔。
Description
本申请是2013年6月14日提交的、名称为“用于进入眼睛的装置、申请号为201180060268.9的中国专利申请的分案申请。
优先权要求
依照35 U.S.C.119(e)(1)要求2010年10月15日提交的美国临时申请序列号61/393,741的优先权，该申请的全部内容以参考的方式并入本文中用于所有目的。
背景技术
脉络膜上腔是位于脉络膜（即眼睛的中间层或血管膜）与巩膜（即眼睛的外（白色）层之间）的眼睛内部的潜在空间。脉络膜上腔从睫状体附近的眼睛前部延伸至与视神经相邻的眼睛后端。由于眼睛的眼内压力所造成脉络膜与巩膜紧密并列，因而通常脉络膜上腔是不明显的。因为脉络膜不与巩膜显著地连接，所以当发生流体蓄积或其它疾病时各组织可以分离而形成脉络膜上腔。脉络膜上腔提供从眼睛前区进入眼睛后区以便输送眼病治疗剂的潜在路径。标准的脉络膜上腔手术进入是通过结膜和巩膜中的切口而实现，并且主要是在手术室中实施。手术进入可用于排出脉络膜积液或出血、以及将微导管和插管放置到脉络膜上腔中以便将药剂输送至眼睛背部。可以通过将适当的活性剂注射到脉络膜上腔中，而治疗疾病（例如年龄相关性黄斑变性、黄斑水肿、糖尿病性视网膜病和葡萄膜炎）。
视网膜下腔是眼睛内部位于感知视网膜和脉络膜之间的潜在空间。视网膜下腔位于视网膜所有部分的下方，从后极附近的黄斑到视网膜锯齿缘（视网膜的前缘）。通常，视网膜下腔是不明显的，因为视网膜需要与下面的脉络膜并列从而实现正常的健康状态和功能。在一些疾病状态中或者作为创伤的结果，会发生视网膜脱落，从而在视网膜下腔中形成液流体填充区。视网膜下腔这种空间通常需要在视网膜功能不可逆的丧失之前进行治疗以重新连接视网膜。然而，已发现一些治疗（例如基因治疗或者细胞治疗）可应用于视网膜下腔以提供与视网膜的最大接触。在功能正常的视网膜中，视网膜下腔中的少量注射造成小面积的视网膜脱落，该脱离在短时间段内分解，从而允许对视网膜直接治疗。
通过将小号针穿透经过视网膜，可以经由内小梁进入视网膜下腔。此过程包括利用针穿透眼睛的眼内空间并且形成小视网膜切开。注射到视网膜下腔中的治疗剂经过视网膜切开流入玻璃体腔，从而导致当治疗剂通过前房水外流通道时治疗剂接触晶状体、睫状体和角膜。
期望具有一种可利用微创方法经由外小梁结膜通路进入脉络膜上腔或视网膜下腔的方法。这种方法将提供一种限制、引导或防护针装置穿透到脉络膜上腔或视网膜下腔中以防止进一步穿透的方法。本发明提供一种能够微创地经结膜路径进入眼睛脉络膜上腔或视网膜下腔以便输送治疗或诊断材料的装置。
发明内容
本发明提供一种包括具有远端和近端的细长主体的装置，所述远端与近端经由主体内的内部通道而连通，其中：
远端构造有锐边或尖头，以穿透到眼睛外壳的眼组织中；
可移动防护元件被设置在第一构造中，以保护眼组织免于被锐边或尖头损伤，并且适合于当用远端进入眼睛中的脉络膜上腔或视网膜下腔时在该装置的远端向眼组织施加指向远侧的力以使组织发生位移而远离该装置的远端；其中，防护元件能够移动至第二构造以使所述锐边或尖头暴露于所述组织以便穿透到所述组织中，
以及进入端口，该进入端口用于在将防护元件布置在脉络膜上腔或视网膜下腔内之后通过细长主体中的通道来输送材料和物质。
在一些实施例中，该防护元件被附接到弹簧或可压缩元件，该弹簧或可压缩元件当其压缩时在防护元件上施加指向远侧的力。
在一些实施例中，该防护元件包括选自液体或气体的可流动材料，该可流动材料被引导流出该装置的远端以便施加指向远侧的力。
在一些实施例中，该装置还包括附接在细长主体的远端的密封元件，该密封元件适合于减少或防止液体或气体通过由该装置产生的组织通道的泄漏。
在一些实施例中，该装置容纳弹簧，以在密封元件上施加远侧力，以提供该元件抵靠眼组织的密封力。
在一些实施例中，该装置包括位于近端的贮器，该贮器用于接收将要被输送至目标空间的材料，并且密封元件与启动元件机械连通以便从贮器释放材料。
在一些实施例中，该装置包括相关的密封元件，该密封元件适合于在穿透到眼睛中期间保持在眼睛的表面上以便接收该装置的远端从而定位该装置并使该装置稳定。
本发明还提供一种用于放置在眼睛巩膜内的装置，该装置包括主体，该主体具有适合于定位在巩膜表面处或附近的近端以及适合于定位在脉络膜上腔或视网膜下腔中的远端；其中，该装置包括内腔以及位于近端的机械限位器，所述机械限位器用于将近端保持在巩膜表面处或附近。
本发明还提供利用本发明的装置进入眼睛的脉络膜上腔或视网膜下腔的方法。
附图说明
图1是眼睛的示意性剖视图以及眼睛各层的详细视图。
图2是根据本发明一个实施例的、包括成角度末端的装置的示意图。
图3是根据本发明一个实施例的、包括设置在主轴内腔中的防护元件的装置的示意图。
图4是根据本发明一个实施例的、包括设置在主轴外侧周围的管状防护元件的装置的示意图。
图5是根据本发明一个实施例的、包括贮器元件的装置的示意图。
图6是根据本发明一个实施例、包括通过穿透所述密封件而启用的密封贮器的装置的示意图。
图7是根据本发明一个实施例、包括在带阀机构的滑动轴上的弹簧加载远侧元件的装置的示意图。
图8是根据本发明的一个实施例的、在具有阀构件的滑动轴上滑动的远侧元件的装置的示意图。
图9是据本发明一个实施例的、包括固定轴和连接到阀构件的滑动外部元件的装置的示意图。
图10是根据本发明一个实施例的、包括加载在主轴周围的密封元件弹簧的装置的示意图。
图11是根据本发明的一个实施例的、包括设置在组织表面上的单独密封机构和穿过该组织而插入的注射元件的装置的示意图。
图12是执行对脉络膜上腔和视网膜下腔的注射的装置的示意图。
图13是根据本发明一个实施例的、包括在套管针上的进入端口的装置的示意图。
图14是描绘利用该装置而放置在脉络膜上腔中的进入端口的示意图。
图15是描绘根据本发明的具有斜切末端和组织接触表面的装置的主轴的示意图。
图16是示例13中所描述测试的结果的曲线图。
具体实施方式
本发明提供经由微创的结膜通路进入眼睛的脉络膜上腔或视网膜下腔的方法和装置，从而无需切开和随后对切开部位进行缝合。该装置也可在部分切开之后（例如眼睛的外巩膜层的切开之后）使用，由此该装置可在切开中使用以进入脉络膜上腔或视网膜下腔。具体地，本发明提供可有利地可用于基于手术室或治疗室的环境能够允许把物质输送至脉络膜上腔或视网膜下腔的装置。具体的用途是该装置输送药物或者含药物的材料的应用，该应用为眼睛提供持续的药物释放。利用该装置注射到脉络膜上腔中的药物可用于治疗脉络膜并且通过脉络膜的脉管系统进入眼睛的内部组织。利用该装置注射到视网膜下腔中的药物可用于对视网膜色素上皮和感知视网膜进行治疗。一些例子包括采用可注射丝或微球形式的聚合物药物释放材料、或者提供对眼睛的缓慢药物释放的具有有限溶解度的药物。有限溶解度甾类化合物（例如曲安奈德或者氯替泼诺碳酸乙酯）是可以用悬浮剂的形式注射到脉络膜上腔中的甾类化合物。
该装置包括具有远端和近端的细长主体，其中操作者在近端握住该装置。远端可构造成穿透结膜和巩膜但不穿透脉络膜而进入脉络膜上腔。替代地，远端可构造成穿透结膜、巩膜和脉络膜但不穿透视网膜而进入视网膜下腔。该装置一旦被放置到脉络膜上腔或视网膜下腔中则可容纳通过远端输送的物质。替代地，近端可构造成接收用于物质输送的器械（例如注射器）。该装置也可适合于将薄壁套管作为端口或导引器放置到脉络膜上腔或视网膜下腔中，从而允许随后的插管或导管的放置和行进。
在某些优选实施例中，该装置适合于限制穿透深度和/或安全地使脉络膜或视网膜发生位移而远离覆盖的组织，由此允许远侧末端穿透到脉络膜上腔或视网膜下腔中，但防止远侧末端穿透脉络膜或视网膜自身或者对脉络膜或视网膜造成损伤。可通过机械或流体机构而提供位移限制或防护元件，以在该装置的远侧末端向眼睛中的组织提供指向前方（远侧）的力。防护元件可由该装置自启动，或者在适当的时间由外科医生手动地启动。连同用作防护元件的流体机构，该装置可包括在穿透眼睛的部位被引导且用于防止流体元件泄漏的密封元件，流体元件泄漏可能导致下面的脉络膜或视网膜的预期位移程度的不希望的下降。
如图1中所示，眼睛1是具有两个主要区段的球体，前区段包含角膜2、虹膜3、睫状体4和晶状体5；并且后区段包含脉络膜6、视网膜7和玻璃体8。眼睛的外壳由四个主要层构成，所述层从外向里是：结膜（眼睛的薄的松散附着的外盖）；巩膜9（构成眼睛的主要结构性部件的白色结缔组织）；脉络膜6（眼睛的血管层）；以及视网膜7（眼睛的感知层）。本发明所要进入的两个目标是巩膜和脉络膜之间的潜在空间（脉络膜上腔10）以及视网膜和脉络膜之间的潜在空间（视网膜下腔11）。
在一个实施例中（图2），根据本发明的装置包括主轴12，该主轴12具有（例如通过内腔15）彼此内部连通的远端和近端。远端可包括斜切的尖锐末端13，其构造成利用最小量的力穿透眼组织以便在巩膜中形成管道或通道。末端13可包括尖头、单个斜面或多个斜面。优选的是，斜切角（表面与顶点处的尖头所形成的角）在10°至30°的范围内。近端可包括附接接收器14，例如阴型鲁尔连接器，用于允许注射器或其它输送器械的附接。主轴12可包括具有内腔15的空心管。主轴12可具有在规格41（0.0028英寸，0.071 mm）至规格20（0.035英寸，0.89 mm）范围内的外直径以及在0.002英寸（0.05 mm）至0.023英寸（0.58 mm）范围内的内腔直径。管可包括金属，例如钨、镍钛诺（镍钛合金）或不锈钢；或者可包括聚合物，例如聚醚醚酮（PEEK）、聚碳酸酯、尼龙或其它类似的结构性工程聚合物。在一个实施例中，主轴12可包括在远端附近的角度或弯曲16。该角度或弯曲用于将远侧末端从垂直于允许简单进入的表面的初始通路引导至沿大致与眼睛的曲面相切的方向进入脉络膜上腔或网膜下腔的路径。弯曲角可以在10°至60°的范围内，并且优选在20°至40°的范围内。
在另一个实施例中（图3），主轴12可包括机械防护件，以使脉络膜或视网膜从尖锐的远侧末端发生位移。该机械防护件可包括可滑动地设置在内腔15内的元件18，或者设置在轴12的直径外部的元件。在第一种情况下，防护件18可包括可滑动地设置在主轴内腔15内的钝末端的细长构件17，该构件具有延伸超过主轴的远侧末端并且利用压缩弹簧19连接到装置主体的防护件远侧末端。防护构件17被弹簧加载成使得当钝的装置末端以相当大的机械阻力遇到组织（例如巩膜）时，防护构件被向后压缩到内腔中，从而暴露该装置的尖锐末端并且允许该尖锐末端穿透组织。在利用尖锐末端在组织中进行期间，弹簧向防护件提供向前的力。当远侧末端遇到可发生位移的开放空间或组织（例如在脉络膜上腔的情况下是脉络膜、或者在视网膜下腔的情况下是视网膜）时，由于对末端的阻力下降因而防护构件17再次向前延伸，在装置的尖锐末端前面，由此使组织发生位移而远离该装置的末端。防护件的组织位移弹簧刚度是在大约0.3 lb/in（0.05 N/mm）至2.8 lb/in（0.50 N/mm）的范围内、优选在4.6 lb/in（0.8 N/mm）至1.4 lb/in（0.25 N/mm）的范围内。防护构件所具有的构造可在一旦防护件被布置且使下面的组织发生位移时则允许流体流动通过主轴的内腔。替代地，防护件可构造成可拆除组件的一部分，使得一旦尖锐末端处在适当的空间中，则可拆除防护件组件，并且可把输送装置（例如注射器）附接到近端以便输送流体、治疗剂或诊断物质。
参照图4，机械防护件可包括可滑动地设置在主轴12的外侧上的管20，其也通过压缩元件21（例如金属或塑料弹簧、具有弹性限制的聚合物、或者可压缩气体贮器）而连接到主轴。将该管的尺寸设计且构造成随主轴进入巩膜中的管道或通道。该装置构造成使得压缩元件21向机械防护件施加力以便在远端提供向后的力。以与图3的前述实施例相似的方式，当管状防护件以大于脉络膜或视网膜（例如巩膜）的机械阻力时遇到组织时，该管向后位移（在近侧方向上），从而暴露尖锐末端且允许尖锐末端穿透组织。当防护件进入组织并且遇到开放空间或软组织（例如脉络膜或视网膜）时，防护件由于阻力减小而向前滑动，从而有效地阻止该装置的远侧末端进一步穿透。
在另一个实施例中，防护件可容纳由液体或气体所组成的可流动的或流体的防护物质，该防护物质被输送通过装置的远端，从而提供向前指向的力，并且当装置的远侧末端进入脉络膜上腔时使脉络膜发生位移，或者当远侧末端进入视网膜下腔时使视网膜发生位移。防护件可包括流体，例如无菌水、生理盐水、平衡的盐溶液、硅油、手术粘弹性的聚合物溶液、或者眼科学接受的全氟化碳流体（例如全氟正辛烷）。
另一方面，防护件可容纳气体，例如空气、氮气（N2）、二氧化碳（C02）、或者用于眼科的气体，例如六氟化硫（SF6）或八氟丙烷（C3F8）。另外，防护件可包括被输送的治疗或诊断制剂的流体或气体。足以使组织发生位移且不使眼睛过度膨胀但允许足够的空间以便安全地执行注射的有用的流体或气体的体积和压力，是在大约10微升至500微升体积和大约0.05mmHg至52 mmHg表压的范围内，优选地在50微升至250微升体积和4 mmHg至30 mmHg表压的范围内。可通过附接到近侧连接器且用流体或气体填充的注射器传送这种流体防护件。
在另一个实施例中（图5），该装置包括用于输送精确量的流体防护物质的加压贮器22。贮器22可构造成以精确的压力和流量输送材料，以实现脉络膜或视网膜的位移，同时防止空间的过度膨胀。贮器22可适合于预先填充至期望的容积和压力。这可例如通过包括用于填充贮器的入口23（例如注射端口、阀、热封帽、或者能够把材料无菌传送至贮器的类似入口，这可在该装置的制造期间完成）而完成。贮器还可适合于能够受控制地进入主轴内腔从而能够把贮器的内容物注射至目标部位。可利用隔膜24、在构造成容纳该装置的启动机构的贮器远端的密封件和塞子而实现进入。在另一个实施例中，贮器可构造成与用作流体防护物质的可流动材料一起输送治疗或诊断物质。
该装置适合于自动地启动液体或气体的输送，或者可由使用者启动和控制该输送。可利用平板或限位器来触发自动输送，当该限位器与眼睛表面接触时该平板或限位器触发液体或气体的输送。在一个实施例（图6）中，该限位器可包括设置在主轴12的外侧周围的管状元件25。可利用压缩元件21（例如金属或塑料环、具有弹性性质的聚合物、或者可压缩气体贮器）将元件25附接到主体。该主轴可包括启动机构，用以释放贮器材料。该机构可包括在主轴近端的尖锐末端26，该尖锐末端26构造成穿刺在贮器22上的隔膜或密封件件24。
在另一个实施例中（图7），该装置包括具有远侧斜切末端13的主轴12以及设置在轴周围的触发限位器37。主轴12设置在包含贮器22的近侧毂38内。贮器包括单向阀27以及在近端的鲁尔连接器28，该连接器28是用于接收附接件以填充贮器。贮器的远端包含聚合物隔膜24。主轴12的近端29被密封并且设置成穿过隔膜。主轴12的近端包括在该该侧上的孔30或阀端口，当装置不被启用时使端口从隔膜向远侧移动。预先利用注射器或气体管路连接用防护流体或气体或治疗剂填充贮器。将管状元件25设置在主轴远侧部分的外侧的周围，利用压缩弹簧21将该元件附接到主轴。弹簧常量是在0.29 lb/in（0.05 N/mm）至14.3lb/in（2.5 N/mm）的范围内、优选在0.97 lb/in（0.17 N/mm）至3.37 lb/in（0.59 N/mm）的范围内。该装置适合于当与眼睛表面接触时，远侧管状元件25向后（在近侧方向上）平移从而抵靠触发限位器37压缩弹簧元件直到该力达到由弹簧刚度和抵靠主轴的隔膜的摩擦系数所设定的预定值。当达到指定的力值时，作用于装置毂的持续的推进压力使主轴向后平移，从而使端口30向近侧移动至隔膜31的贮器侧，释放贮器的内容物而使其离开远侧末端。触发限位器也可以构造成限制主轴向后行进超过贮器内容物被释放的点。当进入脉络膜上腔或者视网膜下腔时，可通过选择弹簧刚度与隔膜摩擦系数的力值组合而在特定的穿透深度进行触发。穿透深度是在大约0.02英寸（0.5 mm）至0.157英寸（4 mm）的范围内。
在另一个实施例中（图8），该装置包括具有远侧斜切末端13的主轴12以及设置在轴周围的管状触发限位器39。触发限位器39具有大于该主轴外直径的内直径并且近端附接到主轴使得触发限位器与主轴之间的间隙面向远端。主轴12被设置在包含贮器22的近侧毂38内。贮器22包括单向阀27以及用于接收附接件以填充贮器的位于近端的鲁尔连接器28。贮器22的远端包含聚合物隔膜24。主轴12的近端29被密封并且被设置成穿过隔膜。主轴的近端包括孔30或者在该侧的阀端口，当装置被启用时该端口从隔膜向远侧移动。预先利用注射器或气体管路用防护流体或气体或者治疗剂填充连接贮器。管状元件25设置在主轴远侧部分的外侧周围附近，元件25包括较厚壁的远侧部分56和薄壁的近侧部分40。将薄壁部的尺寸设计成可在管状触发限位器与主轴之间的滑动。该装置适合于当与眼睛表面接触时远侧管状元件25向后平移直到厚壁部的近端与触发限位器39接触。作用于装置毂的持续的前进推进压力使主轴向后平移，使端口30向近侧移动至隔膜31的贮器侧，从而把贮器的内容物释放入主轴的内腔中。触发限位器39可构造成限制向后运动。该装置部件的长度以及远侧管状元件25与触发限位器39之间的间隙适合于提供特定的主轴远侧斜切末端13的穿透深度。进入脉络膜上腔或视网膜下腔的穿透深度是在大约0.02英寸（0.5 mm）至0.157英寸（4 mm）的范围内。
在另一个实施例中（图9），根据本发明的装置包括具有远侧斜切末端13的管状远侧轴41以及管状近侧轴42。轴41、42被设置成可彼此地滑动并且一个轴的尺寸可被设计成在另一个轴的内部和外部滑动。近侧轴42包括密封的近端29、以及在该侧的孔或者端口30。弹性体密封件43被设置在远侧轴41和近侧轴42的外侧周围，穿过这两个轴之间的连接点并且提供密封以防止液体或气体流出同时允许这两个轴之间的直线运动。利用横杆44将远侧轴固定到近侧毂38。外壳45可滑动地设置在远侧轴的周围并且附接到近侧轴。该外壳包括用于容纳横杆44的槽或切出件46，从而允许外壳和近侧轴独立于固定的远侧轴41而滑动。近侧毂38包括具有聚合物隔膜24的贮器22、允许对贮器加压的单向阀27、以及用于接收附接件以填充贮器的位于近端的鲁尔连接器28。近侧轴的密封的近端29被设置成穿过隔膜，使得在填充贮器期间，使端口30从隔膜24向远侧移动由此密封该贮器。预先利用注射器或者气体管路连接用防护流体或气体或者治疗物质填充贮器。该装置适合于当与外壳的远侧末端的组织表面接触时，使外壳45和近侧轴42向后（在近侧方向上）平移，使端口30向近侧移动至隔膜24的贮器侧，以便将内容物释放入主轴内腔。
在另一个实施例中（图10），连同流体防护物质，该装置也可包括对准在结膜和巩膜穿透的部位的密封元件。该密封件被设计成防止流体或气体通过由该装置所形成的组织通道的泄漏，该泄漏将会减小对准下面的脉络膜或视网膜的流体或气体的量从而使下面的组织位移以防止主轴的尖或斜切的末端穿过。可将该密封件设置在该装置上方，例如作为外管状套管47可滑动地设置在主轴12上包括斜切末端13。该管状套管包括内部密封件48，以套管密封抵靠主轴以防止液体或气体在套管和轴之间倒流。主轴的近端设置在包括用于附接流体或气体输送机构（例如注射器）的鲁尔连接器28的毂38中。该套管的远端用于在微小切开后在眼睛的表面或巩膜表面处密封结膜。该管状套管优选的是在组织表面具有直径从而在组织穿透的部位周围提供充分的面积以提供针对流体防护压力的有效密封。该管状套管的外直径可在0.04英寸（1.0 mm）至0.12英寸（3.0 mm）的范围内，从而提供在眼睛表面上的充分的密封面积并且不过度地使该部位的视觉变得模糊。当内主轴穿透眼睛的外组织时，可利用弹簧机构21帮助管状套管以提供对眼睛表面的密封力。弹簧常量是在0.29 lb/in（0.05 N/mm）至14.3 lb/in（2.5 N/mm）的范围内、优选在0.97 lb/in（0.17 N/mm）至2.0lb/in（0.35 N/mm）的范围内。该弹簧机构可以是机械弹簧或者替代地气体贮器或提供类似弹簧的功能弹性部件。管状套管47的远端可包括与组织表面一致并且促进密封效果且减小所需密封区的橡胶、弹性或可变形材料49。
替代地，（图11）密封元件可以是放置在眼睛上的单独部件50，并且利用该装置来穿透密封件以及下面的结膜和巩膜。该单独部件可以是软聚合物、橡胶或弹性体，其具有提供通过结膜和巩膜到达目标脉络膜上腔或视网膜下腔的合适主轴长度的厚度。该单独部件可具有尺寸设计成配合装置外尺寸的减小厚度的目标区51，当把该装置放置在部件上时帮助该装置的定位和稳定，当把该装置放置在眼睛上时穿透该密封件并且穿透下面的结膜和巩膜。该单独部件也可具有合适的厚度，以便一旦主轴的远端内腔已进入密封件则触发防护流体或气体的释放。单独部件的机械特征（例如凸缘、套管或者向该装置延伸的杆），当它被放置时可触发防护流体或气体的释放。该装置可包括限位器52，其尺寸被设计成配合在控制装置远侧末端进入深度的密封元件目标区51内。
该装置还可包括显示当保护下面的脉络膜和视网膜防护件已被布置时显示并且显示已建立通向脉络膜上腔或视网膜下腔的通道的指示器。指示器可包括深度机械防护件的指示器或者贮器的体积或流量指示器。也可将指示器联接到传感器，用于将视觉信号或听觉信号传送给使用者以限制装置的穿透并且表示可以将材料注射到眼睛的脉络膜上腔和视网膜下腔中。
参照图12，用于注射到脉络膜上腔32或视网膜下腔33中的材料可包括：植入物、药物溶液、药物悬浮剂、含药物的材料（例如凝胶或者固体植入物）、基因治疗剂、干细胞或细胞治疗剂。另外，该装置可包括在布置防护件后使柔性管状元件在脉络膜上腔或视网膜下腔内向眼睛的后端延伸至远端内腔并且将材料提供至更接近眼睛后区的位置的装置。柔性管状元件优选地具有圆形的防止损伤的远端，用以使对脉络膜或视网膜的创伤最小化。
在另一个实施例中（图13），该装置可包括彼此相连通的远端和近端，如前所述，连同被植入巩膜的外套管。该装置的主体可采用具有尖锐末端35的实心构件或空心的管状构件34的形式。该装置可包括机械或流体的防护件，如前所述，用以使脉络膜发生位移从而进入脉络膜上腔或者使视网膜发生位移从而进入视网膜下腔。该装置还包括可滑动地设置在该装置主体的外直径周围的薄壁套管36。当防止该装置时，该套管行进到组织中。当把该装置从眼睛中去除时套管36仍然在后面。如图14中所示，套管36起进入端口或导引器的作用，该端口或导引器从眼睛的外部连通到脉络膜上腔32或视网膜下腔，以便在手术期间将其它装置（例如针、插管或导管）导入空间。通常把该套管的尺寸设计成外直径在大约0.0045英寸（0.11 mm）至0.0355英寸（0.90 mm）的范围内、壁厚度在大约0.0005英寸（0.12 mm）至0.002英寸（0.5 mm）的范围内、长度在大约0.60英寸（1.5 mm）至0.195英寸（5 mm）的范围内。该套管也可在近端具有放大的直径或凸缘，用以把近端固定在眼睛表面。该套管可包括金属，例如镍钛诺、不锈钢、钨；或者聚合物，例如聚酰亚胺、尼龙、聚酰胺、PEEK、或者聚碳酸酯。
该装置还可包括限制远侧末端的穿透深度的特征物。此特征物可包括设置在装置主体外直径周围的机械限位器或凸缘，该机械限位器或凸缘利用限位器接触眼睛表面而限制运动。该限位器可采用平坦表面的形式，该平坦表面可被设置成垂直于装置的主体或者可被设置成与主体成一角度使得该角度近似于相对于装置自身的进入角的球表面的角度。限位器构造可并入用于防护该装置的机构，例如前述的外管状构件。该限位器可以是可调节的，从而允许使用者使该装置适用于不同的组织厚度，例如在眼睛的不同区域。
在许多实施例中，如图15的俯视图中所示，具有尖的或斜切远端13的主轴12将具有合适的进入目标部位的暴露长度。在进入脉络膜上腔的情况下，该长度优选的是当该装置被放置成穿过结膜和巩膜时足以至少使内腔的最远侧部分暴露于脉络膜上腔，从而允许防护防护件进入脉络膜上腔并且使下面的脉络膜发生位移。从解剖学的方面来看，基于0.015英寸（0.38 mm）的结膜和巩膜的最小复合组织厚度，到达内腔远端的此长度最小为0.025英寸（0.65 mm）。在进入视网膜下腔的情况下，主轴长度优选地具有如下长度：当该装置被放置成穿过结膜、巩膜和脉络膜时，使内腔的最远侧部分暴露于视网膜下腔。从解学的方面来看，基于0.023英寸（0.58 mm）的结膜、巩膜和脉络膜的平均复合组织厚度，到达内腔远端的此长度最小为0.023英寸（0.58 mm）。为了使对到达期望目标空间的下面的组织远侧的损伤最小化，主轴长度优选的是不大于覆盖目标空间的近侧组织的厚度加上由于防护元件所造成下面组织的组织位移的量。为了进入脉络膜上腔，此最大长度为大约0.108英寸（2.75 mm）。为了进入视网膜下腔，此最大长度大约为0.118英寸（3.00 mm）。当结合密封元件而使用该装置时，该优选的长度是相对于内腔的远侧边缘53、密封件55的远侧组织接触表面的远侧斜切末端54而言的主轴有效长度。除了解剖尺寸外，主轴的优选的功能长度也应考虑被穿透组织的机械特征以及该装置使用期间的组织变形。
以说明根据本发明的具体装置和方法为目的，而提供下面的示例。这些示例并非意图以任何方式限制本发明的范围。
示例
示例1：
制造根据本发明一个实施例的装置，并且测试该装置成功穿透巩膜并且使脉络膜发生位移从而进入脉络膜上腔的能力。该装置是由作为主轴的针和弹簧加载防护元件所组成。该针元件是由作为主轴的27号（0.4 mm）×0.5英寸（12.7 mm）的短斜切皮下注射针（Monoject，Covidien Inc）所组成。针尖斜切角为18°，近端是标准的鲁尔锁紧连接器。该弹簧加载防护元件是由直径为0.007英寸（0.18 mm）不锈钢丝所构成，其尺寸被设计成可滑动地嵌入针元件主轴的内腔，并且其长度被设计成使得钢丝的远侧末端延伸超过远侧针尖达0.004英寸（0.1 mm）。钢丝的末端为圆形以便不具有任何锐边。将钢丝焊接入较大的不锈钢管，该不锈钢管的尺寸被设计成可滑动地嵌入压缩弹簧的内部。将弹簧连杆焊接到所述管的远端。将内直径为0.049英寸（1.25 mm）且弹簧刚度为0.7 lb/in（0.12 N/mm）的弹簧放置在所述管上。将尺寸被设计成可滑动地配合在弹簧管周围且具有大于弹簧外直径的外直径的第二外管放置在弹簧管的周围，起弹簧的近侧限位器的作用。将钢丝插入针元件的内腔。将Touhy-Borst 鲁尔连接器附接到针鲁尔连接器，然后紧固在外管的周围以将其固定。此弹簧组件允许钢丝向后移动入针。
将人遗体眼睛用于实验。将防护件钢丝末端放置在组织表面上并且使该装置缓慢地行进到组织中。看到防护末端抵抗弹簧压力而回缩，从而允许针尖进入组织。当针已插入大约0.6英寸（1.5 mm）时，停止前进。利用高分辨率光学相干断层扫描（OCT）成像系统对装置位置进行成像。可以清楚地看到针尖在脉络膜上腔并且防护件末端延伸超过针尖并使脉络膜发生位移。
示例2：
制造根据本发明一个实施例的装置，并且测试该装置成功穿透巩膜并使脉络膜发生位移从而进入脉络膜上腔的能力。该装置是由具有尖锐的12°斜切末端的长度为0.79英寸（20 mm）外直径为0.016英寸（0.4 mm）内直径为0.008英寸（0.2 mm）的不锈钢管状主轴所组成。主轴在近侧被结合到塑料阴型鲁尔连接器中。将由内直径为0.0165英寸（0.42 mm）外直径为0.0175英寸（0.45 mm）的远侧薄壁聚酰亚胺管所构成的机械防护元件结合到直径为0.04英寸（1.0 mm）的近侧限位器。聚酰亚胺管的远端是斜切的以便能够进入组织。将防护构件加载到主轴上，内直径为0.017英寸（0.43 mm）且弹簧钢丝直径为0.005英寸（0.13 mm）的不锈钢弹簧位于防护件和塑料毂之间，设置在主轴周围。使用人遗体眼睛对该装置进行测试。把该装置的末端插入巩膜并且使其向前行进。向后推动机械防护件，从而允许尖锐的主轴末端进入巩膜组织。随着持续的前进，防护元件也行进到巩膜中。当主轴的远侧末端进入脉络膜上腔时，弹簧弹力使防护元件前进超过主轴末端，从而使脉络膜发生位移。光学相干断层扫描（OCT）成像确认脉络膜上腔内的防护元件末端位置。
示例3：
制造根据本发明的一个实施例的装置，并且测试该装置成功穿透巩膜并使脉络膜发生位移从而进入脉络膜上腔的能力。该装置是由带尖锐的斜切末端的长度为0.79英寸（20 mm）外直径为0.016英寸（0.41 mm）内直径为0.008英寸（0.2 mm）的金属主轴所构成。在近端将主轴密封并且从近端制作大约0.197英寸（5 mm）的侧孔。该装置的远侧末端成30°的角度并且长度为0.059英寸（1.5 mm）。该装置具有设置在主轴远侧末端周围的弹簧可伸缩金属套管，该金属套管起当回缩时触发气体扩散入脉络膜上腔的机构的作用。将弹簧近端附接到增加对主轴和鲁尔附接件的结构支撑的金属套管。将具有聚合物隔膜的鲁尔连接器固定到主轴的近端，使得主轴穿透隔膜，侧孔在隔膜远侧。将单向阀组件附接到鲁尔连接器，从而可用作提供使气体扩散入脉络膜上腔以使脉络膜发生位移的手段的填充气体的贮器。使用人遗体眼睛对该装置进行测试。将该装置的成角度末端在睫状体平坦部附近插入巩膜，并且使该成角度末端行进直到该成角度末端位于脉络膜上腔内。当与巩膜表面接触时，向后推动远侧金属套管直到弹簧弹力克服隔膜中主轴的摩擦力而驱动主轴的近端穿过隔膜，以便将侧孔定位在隔膜上。经过主轴把室内的气体释放出末端而进入脉络膜上腔。光学相干断层扫描（OCT）成像确认脉络膜上腔内的末端位置以及流体空气防护物质的释放，从而使脉络膜发生位移以防止脉络膜与该末端接触。
示例4：
制造根据本发明一个实施例的装置，并且测试该装置成功穿透巩膜并使脉络膜发生位移而进入脉络膜上腔的能力。该装置的主轴是由带尖锐的斜切平直末端和近侧鲁尔连接器的、外直径为0.016英寸（0.41 mm）内直径为0.008英寸（0.2 mm）长度为0.984英寸（25mm）的注射针所组成。其它设计特征包括金属近侧和远侧外壳组件，由长度为0.197英寸（5mm）的螺旋弹簧来连接直径为0.028英寸（0.7 mm）且长度为0.472英寸（12 mm）的区段。远侧外壳区段具有弹簧可伸缩保护套管以及位于主轴远侧末端的插入深度限位器。近侧外壳区段附接到主轴，用于提高装置刚度。将近侧主轴开放端插入填充有加压流体的贮器的聚合物隔膜。使用人遗体眼睛对该装置进行测试。当把装置远侧末端通过巩膜插入脉络膜上腔时，近侧主轴向后轴向运动，穿透隔膜进入流体贮器。然后，将贮器内容物释放入近侧主轴的开放端并且释放出远侧末端而进入脉络膜上腔。所形成的脉络膜位移防止远侧末端与脉络膜接触，并且利用超声成像实时地确认。
示例5：
制造根据本发明一个实施例的装置，并且测试该装置成功穿透巩膜并使脉络膜发生位移以便进入脉络膜上腔的能力。该装置是由带尖锐的斜切末端的长度为0.79英寸（20mm）外直径为0.016英寸（0.41 mm）内直径为0.008英寸（0.2 mm）的金属主轴所构成。在近端将主轴密封并且在距离近端大约0.197英寸（5 mm）处制作侧孔。将具有聚合物隔膜的鲁尔连接器固定到主轴的近端，使得主轴穿透，侧孔在隔膜远侧。单向阀组件附接到鲁尔连接器，提供大约100微升容积的可填充气体贮器。将具有0.020英寸（0.51 mm）的内直径和0.028英寸（0.71 mm）的外直径的金属套管设置在主轴周围并且附接到近端的附近。该套管起到当被向后推动时触发并将填充气体的贮器释放入脉络膜上腔从而使侧端口平移到隔膜的贮器侧的机构的作用。将由聚酰亚胺所构成的内直径为0.0065英寸（0.17 mm）壁厚为0.0005英寸（0.012 mm）的进入端口元件设置在主轴外侧的周围并将其插入金属套管的下面。使用人遗体眼睛对该装置进行测试。将该装置的末端在睫状体平坦部附近插入巩膜并且使其行进直到末端进入脉络膜上腔并且套管触发贮器的释放，从而注射气体以使脉络膜发生位移。然后，使端口元件行进到脉络膜上腔中。光学相干断层扫描（OCT）成像确认端口位置的远端在脉络膜上腔内并且通过端口注射了流体，同时在成像中确认脉络膜上腔的膨胀。
示例6：
对根据示例5所制造的装置进行测试，基于注入贮器中的气体量而确定气态流体防护物质的输送压力并且确定由于注入贮器气体所获得的脉络膜的位移量。对隔膜压力换能器（PX26-100GV，Omega Engineering）修改以便把鲁尔注射端口放置到换能器端口中，从而使换能器的死体积最小化。将换能器连接到数字读出（DP-41S，Omega Engineering）然后校准并以mmHg为单位读出。将进行测试的装置主轴针尖插入压力换能器的注射端口。拆除单向阀并使鲁尔连接器行进以打开内部阀机构且使系统压力平衡。然后，将鲁尔连接器拉回，关闭内部阀并且重新安装单向阀。将1毫升的注射器用一定体积的空气填充，将该注射器附接到该装置的单向阀鲁尔连接器，然后排出空气以填充贮器。使该装置进行以打开内部阀并且从数字读出仪中读出输送气体的表压。对0.l毫升至0.7毫升的注射器容积进行测试。然而，贮器的实际填充容积小于注射器容积。由于贮器的容积为固定并且手动注射器压缩气体的能力有限，因而在完全压下柱塞后倒流入注射器的少量气体被注射器柱塞反弹。使用人和猪遗体眼睛对其它装置进行体外测试，并且使用活猪动物模型进行体外测试。使用1毫升的注射器用0.2、0.4或0.6毫升空气加载该装置贮器。使这些装置行进到眼睛中，从而启动内部阀并且释放贮器内容物，利用高频超声成像测量所产生的脉络膜位移。下表显示实验结果。
表1
| 注射器装载体积（毫升） | 输送的平均表压（mmHg） | 平均脉络膜位移（mm）-人遗体眼 | 平均脉络膜位移（mm）-猪遗体眼 | 平均脉络膜位移（mm）-活猪眼 |
| 0.1 | 4.7 | - | - | - |
| 0.2 | 8.3 | 0.63 | 0.75 | 0.34 |
| 0.3 | 11.6 | - | - | - |
| 0.4 | 14.8 | 1.01 | 0.86 | 0.61 |
| 0.5 | 18.1 | - | - | - |
| 0.6 | 21.3 | 1.10 | 1.00 | 0.76 |
| 0.7 | 24.4 | - | - | - |
示例7：
测试根据示例5所制造装置的把治疗剂输送至脉络膜上腔的能力。在该实验中使用猪遗体眼睛。被该装置的贮器加载0.5毫升的空气，作为流体防护材料。将含有0.25毫升曲安奈德（TA）（一种皮质甾类颗粒悬浮剂（Kenalog 40，Bristol Meyers Squib））的注射器附接到该装置的近侧鲁尔连接器。该装置被放置成抵靠遗体眼睛的巩膜，并且行进直到远侧末端进入脉络膜上腔且加载贮器气体，从而使脉络膜发生位移而远离末端。在进入脉络膜上腔后，压下注射器柱塞以注射TA悬浮剂。高频超声成像确认脉络膜上腔已被打开并且在脉络膜上腔空中可看到TA颗粒。在可变高度平台上建立由磷酸盐缓冲生理盐水（PBS）的贮器所组成的灌注系统。在贮器的底边将管附接到端口，导向关闭阀以及在端部具有鲁尔连接器的小管。将30号（0.3 mm）皮下注射针附接到贮器鲁尔连接器。提高贮器以提供0.29PSI（15 mmHg）压力。将30号针通过角膜插入前房以提供对遗体眼睛的灌注。以恒定的压力对眼睛灌注6小时。在灌注后，在注射部位上切开眼睛巩膜并将其去除。光学显微镜下的检查显示在注射部位附近在脉络膜表面上的TA颗粒的贮存位置。也注意到颗粒流从注射部位向后延伸大约0.55英寸（14 mm），从而表明朝向眼睛后极的注射物质的流动导向的移动。
示例8：
在另一个测试中，以示例5的方式对根据示例5所制造装置进行测试，然而装置贮器中装载的是甾类悬浮剂而不是空气。将具有其它注射物的注射器附接到该装置。使该装置行进到组织中并且当达到脉络膜上腔时释放贮器液体内容物，使脉络膜发生位移并且允许将注射器中剩余的流体注射到脉络膜上腔中。利用超声成像确认注射位置和组织位移。
示例9：
制造根据本发明一个实施例的装置，并且测试该装置成功穿透巩膜且使脉络膜发生位移而进入脉络膜上腔的能力。该装置的轴和壳体是由304不锈钢皮下注射管制成。该装置是由外直径为0.016英寸（0.4 mm）内直径为0.008英寸（0.2 mm）长度为0.75英寸（19 mm）的远侧轴构成。该远侧轴具有标准的皮下注射器的具有12°主斜切角的斜切末端。将内直径为0.017英寸（0.43 mm）外直径为0.025英寸（0.64 mm）长度为0.24英寸（6 mm）的轴延伸部焊接到远侧轴的背部。将直径与远侧轴相同的长度为0.42英寸（10.8 mm）的近侧轴加以切割，一端是焊接闭塞。在距离焊接端0.005英寸（0.13 mm）处的壁中磨出侧孔。使近侧轴的远端在远侧轴上的轴延伸部内滑动。将一个直径为0.015英寸（0.38 mm）外直径为0.027英寸（0.69 mm）长度为0.2英寸（5 mm）的硬度为50的硅酮管内放置在近侧轴与远侧轴之间的连接点上，以密封该间隙。切割出内直径为0.033英寸（0.84 mm）外直径为0.046英寸（1.17mm）长度为0.71英寸（18 mm）的外壳。从距离外壳远端0.16英寸（4 mm）处开始并且延伸长度为0.5英寸（13 mm），将一半的外壳磨掉而留下半圆的管。将内直径为0.02英寸（0.51 mm）外直径为0.032英寸（0.81 mm）长度为0.55英寸（14 mm）的延伸管焊接入外壳的远端，从而起移动组件的组织接触部的作用。将该远侧/近侧轴组件放置在外壳的内部，并且将横梁焊接到远侧轴。用胶粘剂将横梁粘接到聚碳酸酯鲁尔连接器。在鲁尔连接器近端内部，将硬度为50的硅酮橡胶的实心远盘插入作为隔膜，并且近侧轴的末端仅穿透该隔膜使得侧孔低于隔膜。将鲁尔单向阀附接到鲁尔连接器，从而形成可以从单向阀上的鲁尔连接器进行填充的密封贮器。
使用人遗体眼睛对该装置进行测试。用来自注射器的空气填充贮器。将该装置放置在组织表面上并使其前进。当外壳组件向后平移时，近侧轴中的侧孔平移到隔膜的贮器侧。释放气体而使脉络膜发生位移并将载体药物（Kenalog 40，Bristol Meyers Squib）注射到脉络膜上腔中。利用超声成像确定注射位置。
示例10：
制造根据本发明一个实施例的装置，并且测试该装置成功穿透巩膜且使脉络膜发生位移从而进入脉络膜上腔的能力。该装置是由作为主轴的、具有18°的主斜切角的27号（0.4 mm）0.5英寸（12.7 mm）的短斜切皮下注射针（Monoject 27 g×针1/2，CovidienInc.）所构成。按如下方式制造可滑动密封组件。切割出两个内直径为0.018英寸（0.46 mm）外直径为0.060英寸（1.52 mm）的聚碳酸酯管，长件的长度为0.37英寸（9.4 mm），短件的长度为0.08英寸（2.0 mm）。在长件的近端钻出直径为0.028英寸（0.71 mm）深度为0.05英寸（1.3 mm）的埋头孔。切割出一个内直径为0.015英寸（0.38 mm）外直径为0.027英寸（0.69mm）长度为0.04英寸（1.0 mm）硬度为50的硅酮管，并且插入长管中的埋头孔，作为内密封件。然后，用胶粘剂将短的聚碳酸酯管结合到在埋头孔上长管从而覆盖内密封件。将内直径为0.025英寸（0.64 mm）外直径为0.047英寸（1.2 mm）硬度为50的硅酮管放置在聚碳酸酯组件的远端以形成外密封件。将硅酮管放置成使得远侧边缘延伸超过用作组织表面密封件的聚碳酸酯管的端部。将具有0.97 lb/in（0.17 N/mm）弹簧常量的弹簧放置在皮下注射针上，使密封组件在针上滑动。
使用人遗体眼睛对装置进行测试。用0.l毫升甾类悬浮剂（Kenalog 40，BristolMeyers Squib）填充1毫升注射器，将该注射器附接到该装置。将该装置的末端放置成与组织接触并且施加较小的压力在注射器柱塞上，从而有效地加压流体通道。使该装置行进到组织中，从而保持密封组件与表面接触并维持注射器柱塞上的压力。当针尖行进超过巩膜达充分距离时，能够注射流体，从而使脉络膜发生位移并且将流体注射到脉络膜上腔中。利用超声成像确认注射位置。
示例11：
制造根据本发明一个实施例的装置，并且测试该装置成功穿透巩膜且使脉络膜发生位移从而进入脉络膜上腔的能力。该装置是由弹性组织表面密封件以及作为带整体式深度限位器的主轴的针组件所组成。制造两种不同的组织表面密封件的模型。该表面密封件是由50A硬度硅酮橡胶所构成。制造厚度为0.06英寸（1.6 mm）直径为0.17英寸（4.4 mm）或0.26英寸（6.6 mm）的盘状基部元件。制造外直径为0.17英寸（4.4 mm）内直径为0.06英寸（1.52 mm）的相同厚度的环状密封元件。用利用室温硫化（RTV）硅酮胶粘剂将环状元件粘结到基部元件的中心。制造包括27号（0.4 mm）×0.5英寸（12.7 mm）的短斜切皮下注射针（Monoject，Covidien有限公司）的主轴针组件。将内直径为0.018英寸（0.46 mm）外直径为0.06英寸（1.52 mm）的短长度聚碳酸酯管放置在针轴上，作为深度限位器。将该管切割成使得暴露的针长度为0.13英寸（3.35 mm）。连同组织密封基部的厚度，此长度将会提供进入组织的延伸超过基部元件的0.07英寸（1.75 mm）针长度。深度限位器的外直径被设计成紧密地嵌入并密封于环状密封元件的内直径中。
制备人遗体眼睛。小心地使睫状体平坦部的组织表面干燥，将组织密封组件放置成与组织表面接触并且压下该密封组件以影响密封。在1毫升的注射器中填充0.1毫升的曲安奈德甾类悬浮剂（Kenalog 40，Bristol Meyers Squib）并且将该注射器附接到针组件。将针尖插入基部元件的中心并使其行进，使得深度限位器进入环状元件的内直径，从而密封该流体通道。伴随作用于注射器柱塞的较小压力使针继续行进。当深度限位器到达基部元件且将针插入至全深度时，完成注射。超声成像确认在脉络膜上腔中的注射物。具有不同的基部元件直径的这两种组织密封装置是成功的。
示例12：
通过实施来确定主轴的长度范围，该主轴可允许注射到眼睛的脉络膜上腔中。制造可调节限位器，将其尺寸设计成超过作用主轴的27号（0.4 mm）皮下注射针。该限位器的远端的直径为1.5 mm（0.06英寸）并且可以将限位器加以固定以便能够具有超过该限位器的设定量的针尖延伸。对两种不同的针斜角进行测试。在这些测试中，使用带具有12度标称主斜切角（Precision Glide - 27 ga ×1/2英寸，Becton-Dickenson）和具有18度标称主斜切角（Monoject 250 - 27 ga ×1/2英寸，Covidien）的短斜切针的标准皮下注射针。
取得人遗体眼睛，利用超声成像来确定平均组织厚度。平均表面（巩膜）厚度为0.028英寸（0.70 mm），平均组织总厚度（巩膜和脉络膜）为0.045英寸（0.115 mm）。将曲安奈德（Kenelog-40，Bristol Meyers Squib），一种甾类悬浮剂，用作注射物，因为利用超声成像可清楚地看见注射颗粒。对于每次测试，用0.1毫升曲安奈德来填充1毫升注射器，并且将该注射器附接到测试针。
对于每次测试，将可调节限位器设定为预设的针长度（利用数字卡尺测量）。在睫状体平坦部将针尖插入组织，并且将可调节限位器完全按压在组织表面，并且尝试曲安奈德的注射。然后对注射进行评价，利用超声系统来判断注射是否：（A）不成功，即无注射、过浅；（B）成功地注射到脉络膜上腔中；或者（C）注射到玻璃体内腔中，即过深。下表给出了测试结果、以及可调节限位器远端与针尖内腔远侧边缘之间的距离。这些结果表明大于0.05英寸（1.25 mm）且小于0.12英寸（3.00 mm）的主轴或针长度提供注射到脉络膜上腔中的最佳结果。
表2
| 针长度（mm） | 标准斜切针，远侧限位器到内腔的远侧边缘（英寸/mm） | 标准斜切针的结果（A、B、C） | 短斜切针，远侧限位器到内腔的远侧边缘（英寸/mm） | 短斜切针的结果（A、B、C） |
| 0.25 | 0.002/0.06 | A | 0.003/0.08 | A |
| 0.50 | 0.012/0.31 | A | 0.013/0.33 | A |
| 0.75 | 0.022/0.56 | A | 0.023/0.58 | A |
| 1.00 | 0.032/0.81 | A | 0.033/0.83 | A |
| 1.25 | 0.042/1.06 | B | 0.043/1.08 | B |
| 1.50 | 0.052/1.31 | B | 0.052/1.33 | B |
| 1.75 | 0.061/1.56 | B | 0.062/1.58 | B |
| 2.00 | 0.071/1.81 | B | 0.072/1.83 | B |
| 2.25 | 0.081/2.06 | B | 0.082/2.08 | B |
| 2.50 | 0.091/2.31 | B | 0.092/2.33 | C |
| 2.75 | 0.101/2.56 | B | 0.102/2.58 | C |
| 3.00 | 0.111/2.81 | C | 0.111/2.83 | C |
示例13：
示例5的装置填充有0.3 ml空气以充当流体防护物质。该装置用于在眼睛的睫状体平坦部进入麻醉猪的眼睛脉络膜上腔。一旦把气体注射到脉络膜上腔中，则使用该装置注射0.1 ml（4 mg）的曲安奈德悬浮剂（Kenalog-40，Bristol Meyers Squib）。对十二只眼睛进行注射，在注射后第1、7、14和30天分别取出三只眼。解剖眼睛并且从玻璃体、视网膜、脉络膜和巩膜中在眼睛的四个象限以及后视网膜中穿出6 mm的孔。利用组织的溶剂萃取测定药物在组织中的水平并且反相HPLC定量。图16中所示的结果证实在30天内在眼睛所有区域（包括后视网膜）曲安奈德的持续释放，在脉络膜中有最高水平的药物，并且在巩膜、视网膜和玻璃体中药物水平降低。
Claims (7)
1.一种用于放置在眼睛的巩膜中的装置，所述装置包括：
主体，所述主体具有适合于定位在巩膜表面处或附近的近端以及适合于定位在脉络膜上腔或视网膜下腔中的远端；
内腔；
位于所述主体近端的机械限位器，所述机械限位器用于将所述主体的近端保持在所述巩膜表面处或附近；
附接在主体并设置于弹簧远端的密封元件，所述密封元件适合于减少或防止流体通过由所述装置产生的组织通道的泄漏；以及
弹簧，其用于在所述密封元件上施加远侧力以提供所述元件抵靠眼组织的密封力。
2.如权利要求1所述的装置，其中，所述近端具有比所述远端的直径更大的直径。
3.如权利要求1所述的装置，其中，所述机械限位器包括凸缘。
4.如权利要求1所述的装置，其中，所述主体具有0.071至0.89mm的最大直径。
5.如权利要求1所述的装置，其中，所述主体具有1.5至5mm的长度。
6.如权利要求1所述的装置，其中，所述装置包括位于所述近端的贮器，所述贮器用于接收将要被输送到目标空间的材料，并且所述密封元件与启动元件机械连通以便从所述贮器释放所述材料。
7.如权利要求1所述的装置，还包括相关的密封元件，所述相关的密封元件适合于在穿透到眼睛中期间保持在眼睛的表面上以接收所述主体的远端从而定位所述装置并使所述装置稳定。
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| CN101052434A (zh) * | 2004-04-29 | 2007-10-10 | I科学干预公司 | 用于治疗眼睛的装置和方法 |
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