CN104887388A - 前段药物输送 - Google Patents

前段药物输送 Download PDF

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CN104887388A
CN104887388A CN201510185782.5A CN201510185782A CN104887388A CN 104887388 A CN104887388 A CN 104887388A CN 201510185782 A CN201510185782 A CN 201510185782A CN 104887388 A CN104887388 A CN 104887388A
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insert
component
eyes
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eye
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CN104887388B (zh
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Y·阿尔斯特
小犹金·德胡安
C·J·赖克
S·博伊德
D·西拉
J·D·亚历杭德罗
K·A·麦克法兰
D·萨顿
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ForSight Vision5 Inc
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Abstract

本发明公开了一种治疗系统,包括眼插入件,该眼插入件布置在眼睛的视觉区域外部的区域上。眼插入件包括两个构件:第一骨架构件和第二缓冲构件。第一构件用作骨架框架,它保持植入件沿眼睛前部部分的定位以及提供对第二缓冲构件的支承。该第一构件使得治疗系统保持安装在眼睛的前部部分上至少30天。在一些实施例中,第一构件保持恒定尺寸和形状,例如环形、具有触觉件的环、或者曲线形环,它确定为与下部和上部结膜穹窿约束接合,以便将植入件保持在眼泪流体内和/或抵靠眼睛组织。

Description

前段药物输送
本发明是中国发明专利申请号为201080031182.9(PCT/US2010/037268、国际申请日为2010年6月3日)、发明名称为“前段药物输送”的分案申请。
相关申请的交叉引用
本申请要求美国临时专利申请No.61/183839的优先权,该美国临时专利申请No.61/183839的申请日为2009年6月3日,该文献的整个内容被本文参引。
技术领域
本发明涉及用于眼睛治疗的构件、系统和方法。示例实施例提供了用于药物输送的眼插入件以及使用定位在眼睛前段上或前段附近的眼插入件的方法。示例插入件可以在视觉区域的外部沿眼睛的前表面佩戴,并能够以安全和有效治疗的水平输送一种或多种药物至少30天。
背景技术
多种眼科和非眼科病症需要将多种药物供给眼睛。滴眼剂和凝胶能够是有效药物的输送载体,但是也会有明显的缺点。具体地说,滴眼液与泪液膜中的流体混合,但是可以在泪液膜中停留的时间只有2-5分钟。只有5%的药物可以就地吸收,一些或全部其余部分从泪囊带入泪小管内,并最终吸收至血流中。吸收至血流中可能有至少两个不利效果:第一,大部分药物浪费了;第二,药物存在于血流中可能对身体的其余部分带来有害的副作用。凝胶可以更有效地粘附在眼睛上,但是也可能长时间使得病人的视力模糊。对于某些治疗,滴眼液和凝胶都需要频繁地重复施加。因此,还需要一种向眼睛输送药物的改进方法,该药物不会离开它的目标位置,也不需要频繁地重复施加。
考虑到滴眼液的缺点,可以知道已经提出了多种替代方式。其中,滴眼液的已知替代方式包括将包含或浸渍有药物的构件布置在眼睑下面的治疗方案。
这样的固体眼药剂形式显然与眼睛的滴眼液给药治疗相比具有明显的潜在优点。特别是,眼药输送植入件可以帮助克服传统滴眼液和其它药剂形式的较低病人顺从性、很难施加和频繁错误施加以及滴眼液存在的有效药物吸收有限的问题,同时可能有利于先进聚合物化学处理的有利施加以及引入从其它已知药物输送系统释放维持/控制药物的概念。
尽管药物输送植入件有很大的潜在优点,但是药物仍然主要通过滴眼液来施加在眼睛的前部。可能限制现有眼插入件的接受性的因素包括它们的舒适性较差、它们易于环绕眼睛移动或运动、它们过多引入了在睡眠过程中的不利排斥或眼睛的摩擦、它们与视力干涉、和/或很难布置和取出已知的药物输送植入件。
考虑到上述情况,新的药物输送装置、系统和方法将特别有利于将治疗化合物输送至眼的前段。它将特别有利地提供改进的眼插入件,以便使得医生和用户都可接受,且该插入件理想的是容易插入和取出,使得病人舒适,无毒和不干涉视力或氧渗透、能够有可重复的释放运动、和/或容易以合理的价格来制造。
发明内容
本发明提供了一种输送至少一种药物的治疗系统和方法。示例实施例通过插入件而将一种或多种药物从眼插入件输送给眼睛的前部部分。
在第一方面,本发明的实施例提供了一种治疗系统。该治疗系统包括眼插入件。眼插入件布置在眼睛的视觉区域外部的区域上。眼插入件包括两个构件:第一骨架构件和第二缓冲构件。
第一构件用作骨架框架,它保持植入件沿眼睛前部部分的定位以及提供对第二缓冲构件的支承。该第一构件使得治疗系统保持附着在眼睛的前部部分上至少30天。在一些实施例中,第一构件保持恒定尺寸和形状,例如环形、具有触觉件的环、或者曲线形环,它确定为与下部和上部结膜穹窿约束接合,以便将植入件保持在眼泪流体内和/或抵靠眼睛组织。
在很多实施例中,第一构件展开或者改变形状,以便最大程度地使它附着在眼睛的前部结构上。药物可以分散在第一构件中或第一构件上,或者分散在第二构件中或第二构件上,或者两者都有。
在本发明的示例实施例中,治疗系统设计成用于容易由病人插入和取出。
附图说明
图1-1和1-2表示了适合通过眼插入件来治疗的眼睛2的解剖组织结构;
图2-1表示了包括眼插入件的治疗系统的示例实施例,该治疗系统还可以包括:插入装置;结构改变材料,该结构改变材料进行溶解(或膨胀、变弱、拉紧或执行一些其它驱动机构),以便将植入件从插入结构重新设置成部署结构;等;
图2-2和2-3表示了图2-1中所示的治疗系统的俯视图和剖视图;
图2-4表示了治疗系统的实施例,其中,环包括在它的表面的相对部分上的两个径向向外和/或向前延伸的凸起或凸块;
图2-5表示了环形治疗装置系统的可选实施例。在该实施例中,新月形或香蕉形储存器安装在眼插入件的下部部分上。
图3-1至3-3表示了治疗系统的另一实施例,该治疗系统包括环形构件,该环形构件有至少8mm的直径,尺寸设置成装配在角膜的视觉区域外部,且该治疗系统还有两个或更多触觉件;
图4-1至4-2表示了治疗系统的另一实施例,在该治疗系统中,两个或更多同心环形构件通过四个或更多触觉件而保持在一起;
图4-3表示了采用偏心设计的实施例,这样,一个或多个环部分或弧形段存在于环的下部区域中,以便将目标输送至眼睛的、眼泪可以更容易聚集的区域中(像盲管中那样);
图5-1至5-3表示了治疗系统的蛇形实施例,该治疗系统表示了可膨胀眼插入件;
图6-1和6-2表示了另一实施例,其中,第二缓冲构件包括相互附接的两个水凝胶巩膜隐形眼镜,以便在它们之间夹住第一刚性构件;
图7-1表示了治疗装置系统的示例眼插入件的放大图,其中,第二构件布置在第一构件的整个周边长度上;
图7-2表示了治疗装置系统的剖视图,该治疗装置系统包括具有楔形外边缘和/或内边缘的第二构件;
图7-3表示了治疗装置系统的剖视图,该治疗装置系统包括具有斜角边缘的第二构件;
图7-4表示了治疗装置系统的剖视图,该治疗装置系统包括具有圆角边缘的第二构件;
图8-1表示了具有第二构件的治疗装置系统,该第二构件可以有前表面和/或后表面,该前表面和/或后表面也能够形成眼睛的曲率半径;
图9-1表示了第二缓冲构件,该第二缓冲构件布置在第一支承机构的离散长度部分上;
图10-1和10-2表示了一个实施例,其中,涂层环绕第二构件局部散布,以便使得第二构件在特定区域优先膨胀;
图11-1表示了环形的眼插入件,其中,分开和/或相对的部分在中心处接近或夹紧,以便形成非平面玉米面豆卷(taco)的形状;
图11-2表示了插入至眼睛表面上的环形眼插入件,在可溶解材料允许缓慢地释放回环形之前;
图11-3和11-4表示了一个实施例,其中,环形形状包括蛇形形状或一系列弯头,这样,径向外部部分或凸起与径向内部部分交替;
图11-5和11-6表示了可选实施例88,其中产生三个叶子的三叶草形;
图11-7表示了定位在眼睛表面上的完全膨胀眼插入件;
图12-1和12-2表示了变化的抓紧工具的两个可选方案,其中凹槽或槽在端部,以便于抓紧该装置;
图12-3至12-6表示了抓紧工具的爪的不同实施例,这些抓紧工具变化成具有在凹槽上的特殊形状,以便帮助将装置折叠成与眼的形状匹配的形状,并表示了使用它的方法;
图13-1至13-4表示了从抓紧工具释放环的可选方式;
图14-1至14-5表示了可选的注射器形插入装置以及用于插入环形眼插入件的方法;
图15-1至15-3表示了类似经典自行车喇叭的另一可选眼插入件插入装置;
图16-1至16-6表示了包括柔性锥体的可选插入装置,该柔性锥体沿它的外缘支承环形装置,还表示了使用它来将眼插入件置于眼睛的巩膜上的方法;以及
图17-1至17-2表示了包括柔性弯曲带的可选插入装置。
具体实施方式
图1-1和1-2表示了适合通过眼插入件来治疗的眼睛2的解剖组织结构。眼睛2包括角膜4、虹膜6和白色巩膜8。基本透明的结膜层10覆盖巩膜8。晶状体12布置在角膜4的后面。对光进行响应的视网膜14位于眼睛的后部部分中。凹窝16是视网膜的、提供灵敏聚焦视力的部分。角膜4和晶状体12折射光,以便在凹窝16和视网膜14上形成图像。
图1-2表示了泪系统18,该泪系统18负责产生和排出眼泪流体。泪系统包括两个普通区域:第一,泪腺20和它的排泄管22,该泪腺20分泌眼泪,该排泄管22将流体传送至眼睛表面;第二,泪小管24、泪囊26和鼻泪管28,它们将传送的眼泪流体带入鼻腔内。
图2-1表示了治疗系统30的示例实施例。治疗系统30包括眼插入件31,并可以包括:插入装置;结构改变材料,该结构改变材料进行溶解(或膨胀、变弱、拉紧或执行一些其它驱动机构),以便将植入件从插入结构重新设置成部署结构;等。在可选实施例中,插入装置(或一些其它工具)的驱动也可以使得插入件从插入结构重新设置成部署结构,或者可以只是可释放地保持插入件,以便帮助插入。在还一实施例中,眼插入件在部署之前、过程中或之后并不进行明显的形状或其它特性变化。不过,眼插入件最终定位在眼睛的视觉区域外部的区域上。眼插入件包括两个构件:第一构件32和第二构件34。图2-1表示了布置在眼睛的视觉区域外部的示例治疗系统30。
第一构件
第一构件用作骨架,它大致使得植入件保持相对于眼睛结构的位置,从而将植入件附着在眼睛上,因此提供用于缓冲构件相对于眼睛前部部分的支承。这样的第一或骨架构件优选是保持治疗系统附着在眼睛的前部部分上至少30天。当医疗上希望或者当病人希望时,治疗系统可以比30天更早地除去;不过,从物理的观点来说,它能够保持眼睛前表面的眼插入件至少30天。在一些实施例中,第一构件可以继续帮助将整个植入件保持在眼睛中60天或更长、90天或更长、或者甚至180天或更长,理想的是,在整个这样的植入期间都连续进行安全和有效的治疗药剂输送。可选的治疗装置和方法可以受益于更短的植入周期,可以选择一天或多天、至少几天、一周或更长、两周或更长等。
由于它用作治疗系统30的插入件31的骨架,因此第一构件可以确定眼插入件的总体形状。第一构件通常包括细金属线、硬塑料例如尼龙、PMMA、聚碳酸酯、聚对苯二甲酸乙二醇酯和/或其它聚合物、聚丙烯或者其它能够提供结构支承以便使得治疗系统保持附着在眼睛上的合成缝合材料。第一构件还可以包括涂覆塑料或金属,以使得涂层包含治疗药物,或者使得更容易将第二缓冲元件附着在骨架部件上。第一构件可以进行表面处理,例如等离子体蚀刻等,以便使得第二构件能够合适地附接在骨架部件上。
图2-1表示了第一构件的基本实施例。这里,第一构件32为环形,具有至少8mm的直径,且尺寸设置成装配在角膜的视觉区域外部,以便并不与病人的视力干涉。第一构件32的环带优选是包括完整的环或环面,但是也可以沿它的周边有一些间隙。在这些实施例中,环带的弧形角度将超过180°。图2-2和2-3表示了图2-1中所示的治疗系统的俯视图和剖视图。图2-1至2-3所示的治疗系统的尺寸能够必须更大,以使得构件的边缘将布置于眼睛的盲管内。在治疗系统将位于眼睛的盲管内的实例中,治疗系统将优选是制造成至少两个尺寸,以便适应不同的眼睛尺寸(例如儿童VS成年人,也可选择不同的成年人眼睛尺寸)。第一构件的可选形状包括在美国专利No.3995635中所示和所述的插入件的形状,该文献的内容被本文参引。
图2-4表示了治疗系统30的实施例36,其中,环包括在它的表面的相对部分上的两个径向向外和/或向前延伸的凸起或凸块42。当眨眼时,眼睑将两个凸块“捕获”在眼睑之间,并将眼植入件推回至它在角膜的视觉区域外部的治疗有效位置中(否则该眼植入件能够在眼睛的表面上自由滑动)。
图2-5表示了环形治疗装置系统30的可选实施例40。在该实施例中,新月形或香蕉形储存器42安装在眼插入件的下部部分上。
图3-1至3-3表示了治疗系统30的另一实施例44,该治疗系统30也包括环形构件,该环形构件具有至少8mm的直径,尺寸设置成装配在角膜的视觉区域的外部,且该治疗系统还有两个或更多触觉件46,各触觉件46从环形构件辐射至眼睛的盲管,从而提供用于治疗系统的附加支承点。图3-1表示了布置在眼睛的前部结构上的、具有触觉件的环形治疗系统。图3-2和3-3分别表示了眼插入件44的俯视图和剖视图。
图4-1至4-2表示了治疗系统30的可选实施例48,其中,两个或更多的同心环形构件52通过四个或更多触觉件50而保持在一起。内部环形构件具有至少8mm的直径,且尺寸设置成装配在角膜的视觉区域外部。下一个(和随后)的外部环形构件具有逐渐更大的直径,最外侧环形构件优选是具有至少12mm的直径,且尺寸设置成装配在眼睛的巩膜、穹隆或盲管上。图4-1表示了布置在眼睛上的治疗系统的实施例48。图4-2表示了在插入眼睛上之前的治疗系统的实施例48。实施例48的优点是提供了用于药物输送的更大表面面积,因为存在两个或更多环以及四个或更多触觉件。具有提高表面面积的另外插入件形状可以在美国专利No.4540417中看见,该文献的内容被本文参引。图4-3表示了采用偏心设计的相关实施例49,以使得一个或多个环形部分或弧形段54处于环的下部区域中,以便将目标输送至眼睛的、眼泪更容易聚集的区域,例如在盲管中。这种偏心设计还可以使得装置稳定在更固定的位置,且几乎不可能旋转离开该位置或者运动至眼睛的视觉区域中。此外,目标输送至盲管能够更有效地将一些药物输送至鼻泪系统(除了眼表面之外),例如当为鼻过敏药物时。
在上述实施例中,第一构件通常保持恒定的尺寸和形状,例如环形或者具有触觉件的环形,它锚固/附着在眼睛的隔膜、穹隆或盲管上。
在其它实施例中,第一构件能够膨胀或改变形状,以便提高它在眼睛的前部结构上的附着。图5-1至5-3表示了治疗系统30的蛇形实施例56,它表示可膨胀眼插入件。图5-1表示了插入在眼睛表面上的实施例56;图5-2表示了在插入之前的实施例56,图5-3表示了处于膨胀状态的实施例。多种可选的蛇形结构可以进行发展和变化,以便利用这里所述的缓冲和/或结构改变技术,包括美国专利No.4540417的技术,该文献的公开内容被本文参引。
相对于已经介绍的实施例,骨架部件可以形成为与眼睛的曲率半径相符。
第一构件可以在它吸收来自眼睛中的眼泪流体时膨胀,或者能够通过弹簧作用机构而拉伸。能够在插入眼睛中时膨胀的材料实例包括PVPE、PVA和聚氨酯凝胶。可以通过弹簧作用而拉伸的材料实例包括铂合金、钛合金、所有不锈钢合金和回火金属、各种包层金属和绝缘线。第一构件可以包括形状记忆材料例如镍钛诺,它能够利用热、磁或电磁驱动而从马氏体至奥氏体状态变成合适形状。形状记忆材料的其它实例包括形状记忆聚氨酯、交联横向聚辛烯橡胶、聚降冰片烯聚合物、镍钛诺、聚乙烯、PMMA、聚氨酯、交联聚乙烯、交联聚异戊二烯、环辛烯的均聚物、聚已酸丙酯、(低聚)已酸丙酯的共聚物、PLLA、PL/DLA共聚物、PLLA PGA共聚物以及本领域普通技术人员已知的其它形状记忆材料。
第一构件的另外结构
图6-1和6-2表示了另一实施例58,其中,第二缓冲构件包括两个水凝胶隐形眼镜60,这两个水凝胶隐形眼镜60相互附着,以便在它们之间夹住第一刚性构件。图6-1表示了布置在眼睛表面上的实施例58;图6-2表示了在布置之前的实施例58。在实施例58中,第一构件62用作眼插入件的骨架,并用作药物输送材料。当眼泪流体渗透水凝胶隐形眼镜时,它与第一构件接触,并使得药物洗提至眼泪流体中。另一实施例(未示出)包括外骨架第一构件,该外骨架第一构件包括附着在隐形眼镜前侧的药物输送材料。另一实施例(未示出)包括第一构件,该第一构件包括药物输送材料,该药物输送材料布置在眼睛上并由普通的无药物输送隐形眼镜覆盖,以便提供舒服的眼睑运动。
第二构件
图7-1表示了治疗装置系统30的示例眼插入件31的放大图,其中,第二构件34整个布置在第一构件32的周边长度上。第二构件34提供缓冲,以便于装置的延长植入或佩戴,也可选择充分防止对眼睛的刺激,以便促使病人佩戴治疗系统至少30天。缓冲效果可以至少部分通过在第二构件中使用的材料来获得,还可以通过第二构件的表面和/或边缘形状来获得。在一些实施例中,第二构件可以包括涂层。
第二构件的材料需要为柔性、可生物相容和无刺激的。该材料的示例包括例如水凝胶或硅酮。
不管它的总体形状和结构如何,第二构件的边缘通常形成为防止在它们和眼睑的内部部分之间摩擦。图7-2表示了治疗装置系统的剖视图,该治疗装置系统包括具有楔形外部和/或内部边缘64的第二构件34。图7-3表示了治疗装置系统的剖视图,该治疗装置系统包括具有斜角边缘66的第二构件34。图7-4表示了治疗装置系统的剖视图,该治疗装置系统包括具有圆角边缘68的第二构件34。图8-1表示了具有第二构件34的治疗装置系统30,该第二构件可以有前表面和/或后表面70,该前表面和/或后表面70也能够形成眼睛70的曲率半径。
在一些实施例72中,第二缓冲构件74只沿第一构件的长度布置在某些离散部分上面,需要在尖锐边缘或弯头可能刺激眼睛的位置处。图9-1表示了第二缓冲构件74,该第二缓冲构件74布置在第一支承构件32的长度的离散部分上面。
第二构件还可以包括涂层,该涂层局部布置在第二构件上,该涂层防止否则可膨胀(优选是可水合)的第二构件膨胀。图10-1和10-2表示了实施例76,其中,涂层78环绕第二构件局部散开,以便用于使得第二构件能够在某些区域优先膨胀。图10-1表示了当涂层环绕第二构件80局部散开时的实施例,其中第一构件32处于未水合状态。图10-2表示了图10-1的第二构件80在水合时(因此在膨胀状态76')的实施例。
在一个实施例中,第一和第二构件可以包括具有不同硬度和/或其它特征的类似组分或材料,特别是材料能够进行处理,以便有用于第一和第二构件的合适特性。
药物输送基体
在治疗系统中使用的药物通常布置、嵌入、包封或者以其它方式包含在输送基体中。输送基体可以包含在第一骨架构件或第二缓冲构件内或它们上面。输送基体还包括可生物降解或不可生物降解的材料。输送基体可以包括聚合物,不过它并不局限于此。可生物降解聚合物实例包括蛋白质、水凝胶、聚乙醇酸(PGA)、聚交酯酸(PLA)、聚(L乳酸)(PLLA)、聚(L乙醇酸)(PLGA)、聚乙交酯、聚L丙交酯、聚D丙交酯、聚(氨基酸)、聚二恶磷、聚己酸内酯、聚葡萄糖酸、聚交酯酸-聚环氧乙烷共聚物、改性纤维素、胶原、聚原酸酯、聚羟基丁酸、聚酐、聚磷酸酯酶、聚(α-醇酸)以及它们的组合。不可生物降解的聚合体可包括硅树脂、丙烯酸盐、聚乙烯、聚氨酯、聚氨酯、水凝胶、聚酯(例如、来自E.I.Du Pont deNemours and Company,Wilmington,Del)、聚丙烯、聚四氟乙烯(聚四氟乙烯)、膨胀聚四氟乙烯(ePTFE)、聚醚酮醚(PEEK)、尼龙、挤出胶原、聚合体泡沫状物、硅橡胶、聚对苯二甲酸乙二醇酯、极高的分子量聚乙烯、聚碳酸酯氨基甲酸乙酯、聚氨酯、聚酰亚胺、不锈钢、镍-钛合金(例如、镍钛诺)、钛、不锈钢、钴-铬合金(例如、来自Elgin Specialty Metals,Elgin,Ill;来自Carpenter Metals Corp.,Wyomissing,Pa.)。
为了防止眼插入件在病人体内潜在的过敏反应,眼插入件需要是将包括低变应原的材料。优选是,第一和/或第二构件可以包括材料例如水凝胶、聚乙二醇(PEG)或聚环氧乙烷(PEO),它们防止蛋白质粘附,并因此减小形成过敏反应的机率。也可选择,眼插入件的药物输送基体可以包括抗过敏和/或抗组胺剂,以便防止对眼插入件的过敏反应。在某些实施例中,输送基体还可以包括本领域已知的其它材料。
治疗系统药物
多种药物可以使用治疗系统传送给眼睛。优选是,这些药物将包括对眼睛的长期治疗所需的药物。需要长期治疗的病症实例包括:干眼症、青光眼、过敏症、感染、细菌、病毒和其他传染、慢性发炎症状,例如酒渣鼻角膜炎、睫状体炎和睑炎、选择的视网膜症状,例如糖尿病性视网膜病、与年龄有关的黄斑变性和其他视网膜的症状、外科手术后症状、弱视等。
用于治疗上述病症的一些药物包括:类固醇、抗发炎剂、抗生素、青光眼治疗化合物、抗组胺剂、干眼症药物、神经保护剂、类视黄醇、抗心血管剂、抗氧化剂以及生物药物。
类固醇的实例包括糖皮质激素、孕激素、矿物皮质类固醇或皮质类甾醇。示例的皮质类甾醇包括可的松、氢化可的松、强的松、氢化泼尼松、甲基强的松、氟羟脱氢皮醇、氟米龙、地塞米松、甲羟孕酮、倍他米松、氯替泼诺、肤轻松、二氟美松、瑞美松龙或者莫米松。其它的类固醇实例包括雄激素、比如睾丸激素、甲基睾甾酮或达那唑。
抗发炎剂的实例包括非类固醇抗炎药(NSAID)如吡罗昔康、乙酰水杨酸、双水杨酯(Amigesic)、二氟苯水杨酸(Dolobid)、布洛芬(Motrin)、酮基布洛芬(Orudis)、萘丁美酮(Relafen)、吡罗昔康(Feldene)、甲氧荼丙酸(aAleve,Naprosyn)、环氟拉嗪(Voltaren)、消炎痛(氯苯酰甲氧基甲基吲哚乙酸)、苏灵大(杂酚)、甲苯酰吡啶乙酸(甲苯酰吡咯乙酸)、依托度酸(lodine)、酮咯酸(toradol)、并吡喃(daypro)、或者塞内昔布(celebrex)。
抗生素的实例包括羟氨苄青霉素、青霉素、磺胺药类、红霉素、链霉素、四环素、克红霉素、特康唑、阿齐红霉素、杆菌肽、.卷须霉素、evofloxacin、氧氟沙星、左氧氟沙星、莫喜沙星、加替沙星、氨基糖苷类、托普霉素、庆大霉素、以及多粘菌素B组合,它包括多粘菌素b/甲氧苄氨嘧啶、多粘菌素B/杆菌肽、多粘菌素B/新霉素/短杆菌肽。
青光眼治疗药物包括β阻断剂,例如,噻吗心安、倍他索洛尔、左倍他洛尔和山羊豆苷;缩瞳药如毛果芸香碱;碳酸酐酶抑制剂如布林佐胺和多佐胺;前列腺素如曲伏前列素、贝美前列素和拉坦前列素;seretonergics;胆碱类药;多巴胺能促效药;肾上腺素能促效药如安普尼定和溴莫尼定;以及前列腺素或者前列腺素模拟药物,如拉坦前列素、贝美前列素或曲伏前列素。
抗组胺剂和柱状细胞稳定剂包括奥洛他定和依匹斯汀,急性治疗抗过敏产品酮咯酸缓血酸胺、甲哌噻庚酮延胡索酸盐、氯替泼诺、依匹斯汀HCl、依美斯汀富马酸氢盐、氮斯汀氢氯化物、奥洛他定氢氯化物、甲哌噻庚酮延胡索酸盐;而慢性治疗抗过敏产品包括呱罗来斯钾、奈多罗米钠、洛草氨酸缓血酸胺、色甘酸钠。
抗心血管剂包括生物药剂、兰尼单抗(lLucentis)和贝伐单抗(Avastin)。弱视药物包括麻醉剂和睫状肌麻痹药,如阿托品。干眼药物包括环孢霉素。
药物洗提处理的控制
药物洗提能够通过存在药物的浓度来控制,或者通过将药物埋入或与各种其它化合物组合来控制。药物的特殊可溶性特征(憎水性或亲水性)将确定控制特殊药物的洗提速率的方式。在药物是憎水性的一些实施例中,药物可以精细研磨和分散至包括硅酮或聚合物(例如高亲水性的水凝胶)的第二缓冲构件中。亲水性药物能够固定在第一构件(例如塑料)或第二构件(例如水凝胶)内。用于固定的聚合物的特殊选择取决于药物和它的特征、合适的洗提速率以及包含药物的涂层的壁厚(该壁厚也可以改变洗提速率)。例如,当药物埋入第一聚合物中时,第二聚合物的壁厚至少局部控制药物通过的速率。相反,涂层的壁厚可以用于在药物埋入骨架元件中时控制药物释放。
其它考虑因素可以包括骨架的基质材料的选择以及药物是否包含在骨架中、骨架是否铸造成特殊骨架形状和是否涂覆有水凝胶或其它聚合物。
在憎水性药物中,可以添加包含胆汁盐(去氧胆酸盐、牛磺去氧胆酸盐和甘胆酸盐)或氯酸钙的表面活性剂(例如乙二胺四乙酸EDTA),以便增加它们的可溶性。
相反,为了降低洗提速率,药物颗粒可以进行涂覆,能够制造药物的更低可溶性盐形式,或者速率限制涂层、聚合物或其它材料可以包含在输送基体中和/或输送基体上,以使得药物离开装置的距离或者材料对药物通过的阻力将限制药物从装置流出。
其它变化形式包括聚合物是否吸收足够的水/眼泪流体来迫使药物离开基体,例如海绵状或自然多孔材料,或者具有人工产生孔的材料或其它材料,该材料进行浸透以使得产生渗透泵送效果。
治疗系统的表面面积和几何结构也能够用于控制药物的洗提速率。因此,治疗装置的几何结构能够根据特殊需要而设计成使得眼泪流体流过治疗系统的流量最大或最小。例如,增加表面面积将增加在药物和眼泪流体之间的接触面积。根据目标输送是否合适,装置还可以构成为使得它有在下部或上部穹窿中的更大输送面积/表面面积。相反,为了降低药物的洗提速率,在眼睛和药物颗粒之间的接触面积将减小。
治疗系统涂层
在一些实施例中,第二构件还包括涂层,以便进一步缓和病人的眼睛。涂层可以包括润滑材料,例如来自Biocoat的、基于hyaluronan的涂层。Hydak的优点包括它在润湿时的润滑性、可生物相容和高亲水性,并可以利用薄的柔性涂层来施加,且它是生物活性物质的载体。其它涂层也可以包括来自SurModics(亲水性或药物输送)和Hydromer的亲水性或药物输送涂层。
为了容易进行插入处理,一些实施例将进行涂覆,以使得眼插入件在插入过程中具有坚固质地。一旦这样的眼插入件布置就位,涂层将溶解,以便使得眼插入件变得更舒适,以便每天使用。
治疗系统的插入和取出
治疗系统可以首先通过医生布置在眼睛上,一旦合适的药物输送时间周期结束,随后就由相同或不同的医生来从眼睛的前表面上取下。然后,医生可以选择地教导病人怎样将由他或她自己将眼插入件插入和取出。
装置的插入和取出的难题是保持在刚性和柔性之间的精细平衡。太软的装置将很难插入,而太硬的装置将对于长时间佩戴不舒服。
一种保持在刚性和柔性之间的精细平衡的方式是通过将装置折叠或夹紧成各种形状。在装置中的折叠将产生在插入过程中更有效地保持它的形状的结构,因此与更容易变形的环结构相比有更好的“可推动性”。
为了插入而保持在装置中的折叠的一种可选方案是用可溶解材料来系住折叠,直到装置保持在眼睛中。可溶解材料能够使得形状缓慢地释放成环。
图11-1表示了环形眼插入件31,其中,分开和/或相对的部分在中心靠近或朝着中心夹紧,以便形成非平面的玉米面豆卷(taco)形状82。夹紧的环形装置能够定位成使得一端能够在下部或上部眼睑下面滑动,然后,另一端能够定位在另一眼睑下面。图11-2表示了在插入眼睛的表面上时的眼插入件31,在可溶解材料允许缓慢释放回环形之前;图11-7表示了在眼睛的表面上的所述装置处于它的完全膨胀状态94中。
图11-3表示了一个实施例84,其中,环形形状包括蛇形形状或一系列弯头,以使得径向外部部分或凸起与径向内部部分交替。该实施例有四个凸起,并产生三叶草叶片形状,以使得四个凸起86各自将方便布置在上部和下部眼睑内以及鼻和眼睛的颞部。这种形状的内部部分也可以通过可溶解材料而保持在一起(或相互靠近),但是并不需要如此,因为能够获得很好的初始位置。图11-4表示了在插入眼睛的表面上时的所述实施例84;图11-7表示了在眼睛表面上的所述装置处于完全膨胀状态94。
图11-5表示了可选实施例88,其中产生三叶草形状90。在本例中,顶部凸起92首先插入顶部眼睑的后面,然后,底部的两个凸起将插入底部眼睑的后面。与前述实施例相同,这种形状也可以通过可溶解材料保持就位,但是并不需要如此,因为能够获得很好的初始位置。图11-6表示了在插入眼睛的表面上时的所述装置;图11-7表示了在眼睛表面上的所述装置处于完全膨胀状态94。
还可以通过使用输送仪器来方便装置的插入。图12-1和12-2表示了变化的抓紧工具150和160的两个可选方案,其中凹槽或槽170在端部,以便于抓紧该装置。优选是,爪有向前的远侧表面,该远侧表面有例如包括硅酮或特氟龙的顶部层,以使得它们如果与眼睛的表面接触,它们如果将不会刮擦眼睛。在图12-2中,表示了能够容纳两个或更多爪的输送仪器的实施例,优选是三个或四个爪162(图中为了简化表示了两个爪),当装置160夹持在环上时,这些爪162产生三叶草或四叶草形状。三个或四个爪162通过外部管而同时靠拢,这迫使爪从它们更松弛的外部位置进行压缩。
图12-3至12-5表示了抓紧工具的爪162的不同实施例,这些抓紧工具变化成具有在凹槽上的特殊形状,以便帮助将装置折叠成与眼的形状匹配的形状。图12-3表示了具有槽172的爪,该槽172水平横过爪延伸。图12-4表示了具有槽175的爪,该槽175是弯曲的,以便使得环弯曲成更容易与眼睛的形状相符的形状。
图12-5表示了具有弯曲槽176的爪的可选实施例。在该实施例中,爪包括三个具有水平槽的相邻厚片。如图12-5所示,为了抓住环形眼插入件31,中间厚片178稍微升高,以便能够形成用于环材料的弯曲槽。如图12-6中所示,为了释放眼插入件31,一旦环的凸出折叠与眼睛表面接触,中间厚片向下推动,以使得所有厚片都相互对齐,在三个厚片的侧部延伸的槽这时是水平的,这时,环将很容易地从抓紧工具释放。
图13-1至13-4表示了环从抓紧工具释放的可选方式。图13-1表示了变化的抓紧工具160,该抓紧工具160包括四个爪162,各爪包括位于它的前端处的槽170,该槽170朝向抓紧工具的中心。图13-2表示了变化的抓紧工具160,该抓紧工具160已经在槽170中抓紧眼插入件31,将爪162紧固在插入件上,从而产生四个凸起,以便容易将眼插入件插入病人的眼睑后面。一旦环形装置的凸出折叠部已经布置在眼睛上,具有爪的臂各自转180o,以使得槽并不沿抓紧工具的外周边布置;这时,折叠的环能够很容易滑出,因为它们不再保持在槽中。图13-3表示了变化的抓紧工具160,其中,各爪已经转动大约180o,以使得各槽170这时朝向背离抓紧工具的中心。槽转动180o将导致释放眼插入件31。图13-4表示了从变化的抓紧工具160上释放的眼插入件131。
图14-1至14-5表示了可选装置以及用于插入环形装置的方法。图14-1表示了注射器形装置180,该注射器形装置180包括:筒182,该筒182有扁平尖端184,能够推动眼插入件31穿过该扁平尖端184;以及柱塞186。为了将环形装置插入注射器中,注射器的柱塞拔出,环形装置被折叠成扁平的,并插入注射器的本体中,柱塞放回在注射器中。图14-2表示了注射器形装置180,其中,眼插入件被折叠成扁平的,并插入筒182中。柱塞186插入筒中,且筒包括管腔,开口尖端包括口,能够推动插入件31穿过该口。为了将环形装置插入眼睛中,柱塞推入注射器的本体内,以便使得环形装置缓慢地挤压通过注射器的扁平尖端。图14-3表示了基本从注射器形装置180的尖端184挤出和准备布置在眼睛的巩膜上的眼插入件31的环。图14-4表示了局部布置在眼睛的巩膜上的眼插入件31的环;将推动眼插入件的其余部分通过注射器形装置180的尖端184,并释放至眼睛上。图14-5表示了布置在眼睛的巩膜上的眼插入件31。
图15-1至15-3表示了类似经典自行车喇叭的另一可选眼插入件插入装置。图15-1表示了自行车喇叭形插入装置180,该插入装置180包括两个部件:喇叭182和挤压球184。图15-2表示了喇叭182的放大图。喇叭包括柔性材料182,具有槽道188,该槽道188使得挤压球与插入装置的外缘连接。喇叭的外缘包括槽186,该槽186的尺寸设置成与环形装置配合。图15-3表示了自行车喇叭形插入装置的剖视图,该插入装置包括喇叭和挤压球。挤压球包括真空源和用于液体190(优选是盐水)的储存器。挤压球安装在喇叭上。
为了拾取环形装置以便插入在眼睛的表面上,对挤压球进行挤压,从而产生真空密封,该真空密封将拾取环形装置并将它保持在喇叭的外缘的槽内。为了将环形装置布置在眼睛的前表面上,将喇叭轻柔地插入眼睛的两个眼睑的下面,并稍微挤压该挤压球,从而使得液体从挤压球的储存器流过喇叭的槽道,从而破坏在环形装置和喇叭的外缘之间的真空密封。然后,轻柔地将喇叭从眼睑的下面拉出。
图16-1至16-6表示了可选插入装置192。图16-1表示了可选的插入装置192,该插入装置192包括柔性锥体194,该锥体194沿它的外缘196支承环形装置,该图还表示了使用它来将眼插入件布置在眼睛2的巩膜8上的方法。图16-2表示了输送装置196的外缘的放大图。外缘包括设计成与环形眼插入件31配合的槽198。图16-3表示了包括柔性锥体的插入装置192的正视图。柔性锥体包括两个狭槽198,以便能够改变锥体的直径。图16-4至16-6表示了使用插入装置192来插入眼插入件31的方法。图16-4表示了装有环形眼插入件31的插入装置192,该眼插入件31轻柔地挤入顶部眼睑202和底部眼睑204的下面。图16-5表示了夹紧或拉动的柔性锥体194,以便降低锥体的周边,并从锥体的外缘196释放环形眼插入件31。图16-6表示了留在眼睛中的环形眼插入件31,而锥体194从眼睑下面拉走。
图17-1至17-2表示了可选的插入装置。图17-1表示了包括柔性弯曲带208的插入装置206。如图17-2中所示,弯曲带包括弯曲槽,该弯曲槽能够支承眼插入件31,同时眼插入件轻柔地滑动至至少一个眼睑的后面。
实例1:对于眼插入件的药物治疗有效剂量的计算-奥洛他定
下面将通过用于治疗过敏病症的药物奥洛他定来演示能够用来根据药物的给药治疗区域而计算药物的治疗有效设备输送剂量的方法。计算方法包括以下步骤:1)确定每次施加的合适滴数;2)使得滴数乘以30uL(一滴的容积);3)确定每uL的固体药物量;4)使得步骤2的结果乘以步骤3的结果,以便找到要每天施加给眼睛的固体药物量;5)使得步骤4的结果乘以希望用该特殊药物治疗的天数;以及6)与药物输送效率相乘。最终量优选是将从眼插入件发散。
奥洛他定是一种眼抗组胺剂(H I-接收器)和柱状细胞稳定剂。奥洛他定的普通成年人剂量例如可以是每天两次,在每个受影响的眼睛中一滴(当使用0.1%溶液)和在每个受影响的眼睛中每天一滴(当使用0.2%溶液时)。
当估计使用0.1%的奥洛他定溶液时,1mL的药物对应于1mg的药物。一滴是30uL,这对应于0.03mL的溶液和30ug的奥洛他定。因为0.1%的溶液每天施加两次,因此奥洛他定的每天剂量是60ug。由于滴眼液在药物输送中的低效,施加给眼睛的奥洛他定的90-95%被冲走。这在眼睛中只留下3-6ug的奥洛他定。对于3-6ug每天,用于30天的量为大约90-180ug的奥洛他定,它可以在一个月的时间内输送给一只眼睛。
实例2:对于亲水性药物的药物输送处理过程和洗提速率控制-奥洛他定氢氧化物
用于眼用途的奥洛他定HCl(OH)能够配置为0.2%(2mg/mL)溶液。包含100ug OH的50uL单滴可以一天一次的滴入眼睛内并持续2周。当估计5%的可用性时,给出5ug/天的剂量输送给隔膜,在2周治疗期间总共70ug。通过用隔膜(例如HEMA、PVA、PVP、GMA、纤维素透析管等)来将药物储存器分割开或者将药物嵌入植入件中而将干形式的至少70ug装入植入件中并释放到泪液膜中。释放速率可以通过改变暴露在泪液膜中的表面面积、通过改变药物释放控制隔膜等来控制,以便调节至合适的5ug/天(0.21ug/小时)。再在计算中假定100%的目标剂量都到达它的目标位置,而并不由泪液膜冲走,更准确的计算可能利用冲走数据来进行。
对于两个实例,植入件的外侧将涂敷有例如用于在水合处理过程中直接给药的药丸,因此药物能够横过隔膜或穿过储存器流动。这些涂层可以成具有很容易溶解层(例如淀粉、糖)的固体药物形式,以便保持使得固体药物布置在植入件的外部。
实例3:对于憎水性药物的药物输送处理过程和洗提速率控制-醋酸强的松龙
通常,1%的醋酸强的松龙悬浮液(10mg/mL)为2滴(总共大约100uL容积)4次每天,并持续一周。估计5%的剂量实际可用于吸收至角膜内,该量为20ug/天的醋酸强的松龙。这样,一周可用剂量为140ug。成水溶液的醋酸强的松龙的可溶性为近似240ug/mL。至少140ug的固体醋酸强的松龙可以装入植入件中,从而使得醋酸强的松龙以大约0.83ug/小时的速率溶解至眼泪层中。该速率可以通过控制植入件的孔隙度以及暴露于泪液膜中的表面面积来控制。
对于这些简化计算,假定100%的剂量在目标(角膜)位置和完全被吸收,并不由于从角膜流走的眼泪层而产生损失。调节可以基于测试数据、建模等来进行。
尽管已经通过示例实施例稍微详细地介绍了示例实施例,但是本领域技术人员应当知道可以进行多种变化、改进和改变。因此,本发明的范围只是通过附加权利要求来限制。

Claims (10)

1.一种眼插入件,用于眼睛中,眼睛具有可沿前部眼睛表面延伸的上部眼睑和下部眼睑,并有在它们之间的视觉区域,该插入件包括:
第一构件,该第一构件可沿病人的眼睛的前表面布置在视觉区域的外部,该第一构件设置成帮助保持插入件,使得插入件与眼睛接触多天;
第二构件,该第二构件由第一构件支承;以及
至少一种药物,该药物设置在第二构件上或在第二构件中,以便在该多天的每一天中将安全和治疗有效量的药物释放给眼睛。
2.根据权利要求1所述的眼插入件,其中:该第二构件构造成在第一构件和眼睛之间缓冲接合,以便当第一构件帮助保持插入件与眼睛接触多天时防止刺激眼睛。
3.根据权利要求1所述的眼插入件,其中:插入件有环形的防排斥形状,具有后表面、前表面以及在后表面和前表面之间延伸的径向内侧边缘和外侧边缘,所述后表面用于与眼睛的前表面接合,第一构件沿环形形状的周边延伸,以便充分保持环带的形状,从而将插入件捕获在上部眼睑和眼睛的前表面之间,以及在底部眼睑和眼睛的前表面之间,第二构件布置在第一构件和眼睛组织之间,眼睛组织包括巩膜和/或至少一个眼睑。
4.根据权利要求1所述的眼插入件,其中:该多天包括至少30天。
5.根据权利要求1所述的眼插入件,其中:药物包括从以下组中选择的一种或多种,该组包括:
类固醇、抗发炎剂、抗生素、青光眼治疗化合物、抗组胺剂和/或干眼症化合物。
6.根据权利要求1所述的眼插入件,其中:药物包括从以下组中选择的一种或多种,该组包括:
类固醇,包括糖皮质激素、孕激素、矿物皮质类固醇、皮质类甾醇;皮质类甾醇包括可的松、氢化可的松、强的松、氢化泼尼松、甲基强的松、氟羟脱氢皮醇、氟米龙、地塞米松、甲羟孕酮、倍他米松、氯替泼诺、肤轻松、二氟美松、瑞美松龙、莫米松、雄激素、睾丸激素、甲基睾甾酮和/或达那唑;
非类固醇抗炎药,包括吡罗昔康、乙酰水杨酸、双水杨酯(Amigesic)、二氟苯水杨酸(Dolobid)、布洛芬(Motrin)、酮基布洛芬(Orudis)、萘丁美酮(Relafen)、吡罗昔康(Feldene)、甲氧荼丙酸(aAleve,Naprosyn)、环氟拉嗪(Voltaren)、消炎痛(氯苯酰甲氧基甲基吲哚乙酸)、苏灵大(杂酚)、甲苯酰吡啶乙酸(甲苯酰吡咯乙酸)、依托度酸(Lodine)、酮咯酸(Toradol)、并吡喃(Daypro)、和/或塞内昔布(Celebrex);
抗生素,包括羟氨苄青霉素、青霉素、磺胺药类、红霉素、链霉素、四环素、克红霉素、特康唑、阿齐红霉素、杆菌肽、卷须霉素、evofloxacin、氧氟沙星、左氧氟沙星、莫喜沙星、加替沙星、氨基糖苷类、托普霉素、庆大霉素、多粘菌素B组合、多粘菌素B/甲氧苄氨嘧啶、多粘菌素B/杆菌肽、和/或多粘菌素B/新霉素/短杆菌肽;
青光眼治疗药物,包括β阻断剂、噻吗心安、倍他索洛尔、左倍他洛尔、山羊豆苷、缩瞳药、毛果芸香碱、碳酸酐酶抑制剂、布林佐胺、多佐胺;前列腺素、曲伏前列素、贝美前列素、拉坦前列素;seretonergics;胆碱类药;多巴胺能促效药;肾上腺素能促效药、安普尼定、溴莫尼定、前列腺素或者前列腺素模拟药物、拉坦前列素、贝美前列素和/或曲伏前列素;
抗组胺剂和柱状细胞稳定剂,包括奥洛他定和依匹斯汀、急性治疗抗过敏产品、酮咯酸缓血酸胺、甲哌噻庚酮延胡索酸盐、氟替泼诺、依匹斯汀HCl、依美斯汀富马酸氢盐、氮草斯汀氢氯化物、奥洛他定氢氯化物、甲哌噻庚酮延胡索酸盐、慢性治疗抗过敏产品、哌罗来斯钾、奈多罗米钠、洛草氨酸缓血酸胺、色甘酸钠;和/或
治疗干眼睛化合物,包括环孢霉素。
7.根据权利要求1所述的眼插入件,其中:药物是亲水性的,且药物分散在亲水性聚合物中。
8.根据权利要求1所述的眼插入件,其中:药物是憎水性的,且插入件包括用于增加药物的可溶性的表面活性剂。
9.根据权利要求1所述的眼插入件,其中:药物是憎水性的,且插入件包括洗提速率降低材料,该洗提速率降低材料包括在药物上面的涂层、输送基体组分和/或在输送基体上的涂层。
10.根据权利要求1所述的眼插入件,其中:第一构件包括环带,该环带有从以下组中选择的部件:
两个径向凸起,这两个径向凸起从环带径向向外延伸,以便在眨眼时与眼睑接合和将插入件定位成环绕视觉区域。
沿环带的至少一部分的局部增厚;
从环带径向延伸的多个触觉件;
至少一个圆弧,该圆弧与环带径向偏移;以及多个径向部件,这些径向部件在该至少一个圆弧和环带之间延伸;或者
径向内部部分,该径向内部部分与径向外部部分分散布置。
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