CN101495072A - 眼科注射器 - Google Patents

眼科注射器 Download PDF

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CN101495072A
CN101495072A CNA2006800304161A CN200680030416A CN101495072A CN 101495072 A CN101495072 A CN 101495072A CN A2006800304161 A CNA2006800304161 A CN A2006800304161A CN 200680030416 A CN200680030416 A CN 200680030416A CN 101495072 A CN101495072 A CN 101495072A
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CN101495072B (zh
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D·A·马什
T·R·罗德斯特罗姆
A·L·韦纳
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    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
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    • A—HUMAN NECESSITIES
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    • 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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    • 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
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A—HUMAN NECESSITIES
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    • A61M2210/00—Anatomical parts of the body
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Abstract

一种改进药物输送的眼科注射器，其具有带有加热室的头锥、加热组件和针。

Description

眼科注射器
技术领域
本发明总体上涉及眼科药物输送，更具体地涉及眼睛后部的药物输送。
背景技术
目前的玻璃体内药物输送装置通过眼睛的没有视网膜组织的睫状体平坦部把药物送到玻璃体，以避免并发症，如视网膜脱落。这种例子包括可以从Bausch&Lomb公司得到的
Figure A20068003041600041
植入物和
Figure A20068003041600042
植入物，二者都要求比较大的睫状体平坦部切口(例如1-5mm)，以便进行植入。一直用于输送匹鲁卡品治疗青光眼的OCUSERT装置通过22号口径的针在睫状体平坦部注射可生物降解或可生物侵蚀的药丸，该注射程序不是“自密封”的。
授权给Bucalo的美国专利No.4,030,499提出了一种注射器，该注射器包含固体状态下的植入物。该注射器包括位于注射筒外部或注射筒内的加热线圈和相关的针，用于在注射到身体组织之前把固体植入体转变为液体。但是，这种线圈设计可能导致制造成本增加和潜在的可靠性问题。授权给Rosenman的美国专利No.6,488,659公开了一种带有热传递流体通道的导液管，用于把一种热敏凝胶材料注入到病人体内的远地点。通过注射器将热敏凝胶材料输送到导液管。导液管使热敏凝胶材料保持液态，直到输送给目标组织。但是，导管式的药物输送不适于眼科应用。
眼睛后部的某些疾病和条件一直在威胁着视力。老年黄斑变性(ARMD)、脉络膜新生血管(CNV)、视网膜变性(如糖尿病视网膜变性、玻璃体视网膜病变)、视网膜炎(如巨细胞病毒(CMV)性视网膜炎)、葡萄膜炎、黄斑水肿、青光眼和神经疾病就是一些例子。因此继续存在改进眼睛后部的药物输送的需要，这种改进不受当前装置的上述限制。
发明内容
一方面，本发明是一种眼科注射器，该注射器包括头锥、剂型、针、柱塞组件和加热组件。头锥具有加热室。剂型为固态并位于加热室中。针与加热室流体连接，并且柱塞组件具有至少部分位于加热室中的杆。加热组件位于头锥上。加热组件加热所述头锥和加热室，以使剂型从固态转变为液态，并且头锥把足够的热传递给针，以防止液态剂型在针内重新固化。
本发明的另一方面是一种眼科注射器，该注射器包括加热室、剂型、针、柱塞组件和加热组件。剂型为固态并位于加热室内。针与加热室流体连接，并且其长度和直径能够使其在睫状体平坦部以外的点插入到玻璃体中。柱塞组件具有至少部分位于加热室内的杆。加热组件用于加热加热室，以使剂型从固态变为液态，从而使杆能够通过针来注射剂型。
附图说明
为了更完整地理解本发明和本发明的目的和优点，参照结合附图进行的以下描述，其中：
图1是根据本发明优选实施例的眼科注射器的平面图；
图2是沿图1的2-2线的注射器侧视剖面图；
图3是图1注射器的分解透视图。
具体实施方式
参照图1-3可以更好地理解本发明的优选实施例和它们的优点，不同图的相同和对应的部分用相同的标记表示。
眼科注射器5大致包括壳10、柱塞组件12、致动组件14、头锥16、加热组件18、针19和剂型(dosage form)60。壳10包括左壳10a和右壳10b，它们通过销固定件20和销子(未出示)可拆卸地摩擦连接。壳10优选包括用于抓握眼科注射器5的区域11。柱塞组件12优选包括远端杆22、基座24和近端杆26。杆26有螺纹端28，用于与调节螺母30旋转连接。柱塞组件12还包括O形环29，用于流体密封眼科注射器5的各种表面。致动组件14优选为柱体32，该柱体具有用于接受柱塞组件12和保持加压流体体积的孔34。加压流体优选为空气。柱体32优选具有用于放置在开口38中的配件36。配件36具有与孔34流体连通的腔管40。腔管40与管子41流体连接。管子41用于与眼科注射器5外部的加压流体源43流体连接。头锥16优选包括加热室42和加热组件固定件48。头锥16优选由具有高导热性的材料并最优选由铝制成。加热组件18具有其几何形状与加热组件固定件48相配的主体50。加热组件18还具有与接口51电连接的电源线52。接口51用于与眼科注射器5外部的电源53电连接。针19是与加热室42流体连通的自密封针。针19优选为长度约为0.5到5mm的23-25号口径的不锈钢针。
包括药品62的剂型60在眼科注射器5的制造过程中以无菌方式位于加热室42中。剂型60是低熔点剂型，其能够以液态输送给眼睛，在目标点固化，并以控制或持续释放的量把药品62输送到目标点。剂型60的熔点优选在大约40℃到80℃之间，并优选为在体内固化后可生物降解或生物侵蚀。剂型60优选被加热，以液态放入加热室42内，然后固化。加热室42优选装有大约1-100μL的剂型60。当然，对带有不同药品62的剂型60，所需的剂型60的体积可以变化。药品62可以是任何眼睛可以接受的药品。药品62优选为一种眼科可以接受的治疗或预防眼睛后部疾病或状态的药品，这些疾病或状态包括老年黄斑变性(ARMD)、脉络膜新生血管(CNV)、视网膜变性(如糖尿病视网膜变性、玻璃体视网膜病变)、视网膜炎(如巨细胞病毒(CMV)性视网膜炎)、葡萄膜炎、黄斑水肿、青光眼和神经疾病。剂型60还可包括其它眼科可以接受的赋形剂，包括改变其熔点的赋形剂。
一旦剂型60位于加热室42内，可以通过销子和销固定件20固定左壳10a和右壳10b。然后将调节螺母30沿近端杆26的螺纹端28移动到适当位置，以调节用于剂型60的适当体积的柱塞组件12的行程(throw)。然后优选将调节螺母30锁定就位，防止随后的调节。然后可以将眼科注射器5放在它的最后包装中并进行消毒。
加压流体源43和电源53优选分别通过接口66和68与计算机或微处理器64电连接。控制器70也优选通过接口72与微处理器64电连接。控制器70优选为脚踏控制器(foot controller)。
现在详细描述使用眼科注射器5给眼睛输送药品的优选方法。眼科注射器5特别用于将药品输送到眼睛后部。由于针19的短的长度和自密封的性质，眼科注射器5可以在睫状体平坦部以外的地点插入到玻璃体中，对视网膜组织大面积干扰的可能性非常小，即使针19穿过视网膜插入。眼科注射器5将剂型注入到眼睛后部任何地方的能力使特定目标组织处的药品浓度最大，因此降低了有毒副作用的可能性。另外，眼科注射器5可以用于把剂型注入到眼睛后部或前部的其它部分。
在输送药品前，护士使管子41与加压流体源43流体连接，并且使接口51与电源53电连接。医生在无菌区域内通过控制器70起动电源53。加热组件18加热头锥16，因此加热加热室42，使剂型60迅速从固体转变成液态。微处理器64优选对特定剂型60针对性地作用一定的电量和加热时间。医生通过区域11抓握眼科注射器5，并且对被麻醉的病人开始执行输送程序。将针19在靠近目标组织的后部的一部分处插入到眼睛的玻璃体中。通过控制器70起动致动组件14，以便把远端杆22移动到加热室42内。微处理器64优选控制用于特定剂型60的致动压力和时间。液化的剂型60从加热室42穿过针19流入目标组织。一旦到达目标组织，剂型60在目标组织上固化，并开始有控制地或持续释放药品62的输送。医生从玻璃体取出针19，并且针19造成的开口自密封。使管子41和接口51分别与电源43和加压流体源53断开。然后将眼科注射器5优选放在尖锐物收集器(sharpscollector)中。
微处理器64控制电源53，使加热组件18将剂型60加热到一定温度，该温度使剂型在穿过针19直至到达目标组织时保持为液态，但低于可能损伤或刺激目标组织的温度。头锥16与针19之间的被动热传递优选有利于该方法，不需要通过通电线圈或其它加热装置主动加热针19。
如上所述，应当理解，本发明提供了把各种药品安全、有效、以可控的速率和局部输送到眼睛中特别是输送到眼睛后部的改进装置和方法。本发明在这里通过例子来示出，本领域专业人员可以进行各种修改。例如，虽然上面描述的本发明使用具有气动组件14的柱塞组件12，但是也可以使用各种其它机械式或机电式柱塞和致动组件，如弹簧致动的柱塞组件、带有柱塞的电动线性致动器，或者带有柱塞的电动步进马达。作为另一个例子，注射器5可以用于向身体中除眼睛以外的目标组织输送药品。
从上面的描述中应该可以清楚地了解本发明的操作和结构。虽然已经示出或描述的装置和方法称其为优选的，但是可以对其做出各种改变和修改，而不超出下面的权利要求所限定的本发明的范围。

Claims (10)

1.一种眼科注射器，包括：
具有加热室的头锥；
位于所述加热室内的固态剂型；
与所述加热室流体连接的针；
柱塞组件，其具有至少部分位于所述加热室内的杆；以及
位于所述头锥上的加热组件；
由此，所述加热组件加热所述头锥和所述加热室，以使所述剂型从固态转变为液态，并且所述头锥把足够的热传递给所述针，以防止所述剂型在所述针内从所述液态重新固化。
2.如权利要求1所述的眼科注射器，其中所述加热组件不主动加热所述针。
3.一种眼睛注射器，所述眼睛具有睫状体平坦部、玻璃体和视网膜，该注射器包括：
加热室；
位于所述加热室内的固态剂型；
与所述加热室流体连接的针，所述针的长度和直径能够在所述睫状体平坦部外的其它点插入到所述玻璃体内；
柱塞组件，其具有至少部分位于所述加热室内的杆；
加热组件，其用于加热所述加热室，以使所述剂型从固态转变为液态，从而使所述杆能够通过所述针来注射所述剂型。
4.如权利要求3所述的注射器，其中所述针具有23号或更大的口径。
5.如权利要求4所述的注射器，其中所述针具有23-25号的口径。
6.如权利要求3所述的注射器，其中所述针的长度约为0.5mm到5mm。
7.如权利要求5所述的注射器，其中所述针的长度约为0.5mm到5mm。
8.如权利要求3所述的注射器，其中所述针能够穿过所述视网膜插入到所述玻璃体中。
9.如权利要求8所述的注射器，其中所述针能够穿过所述视网膜插入到所述玻璃体中，而不使所述视网膜脱落。
10.如权利要求3所述的注射器，其中所述针是自密封的。
CN2006800304161A 2005-08-22 2006-07-19 眼科注射器 Expired - Fee Related CN101495072B (zh)

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CN103052367A (zh) * 2009-08-10 2013-04-17 苏尔莫迪克斯公司 用于玻璃体内注射的方法、装置及组合物
CN111249062A (zh) * 2012-07-03 2020-06-09 诺华股份有限公司 注射器
CN105832460A (zh) * 2016-03-07 2016-08-10 张友岩 一种眼科注射器
CN110368184A (zh) * 2019-08-08 2019-10-25 哈尔滨工业大学 用于眼科手术机器人的视网膜血管注药器及其注射方法
CN110368185A (zh) * 2019-08-08 2019-10-25 哈尔滨工业大学 一种用于眼科手术机器人的视网膜血管注药器
CN110368184B (zh) * 2019-08-08 2021-05-04 哈尔滨工业大学 用于眼科手术机器人的视网膜血管注药器及其注射方法
CN112657019A (zh) * 2021-01-11 2021-04-16 林文利 一种储备式自动换针头的胰岛素笔及其使用方法

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AR057503A1 (es) 2007-12-05
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RU2387462C2 (ru) 2010-04-27
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US20070060887A1 (en) 2007-03-15
KR101067927B1 (ko) 2011-09-26
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CA2615763A1 (en) 2007-03-01
WO2007024369A2 (en) 2007-03-01

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