CN1376042A - 眼药释放装置 - Google Patents
眼药释放装置 Download PDFInfo
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- CN1376042A CN1376042A CN00813192A CN00813192A CN1376042A CN 1376042 A CN1376042 A CN 1376042A CN 00813192 A CN00813192 A CN 00813192A CN 00813192 A CN00813192 A CN 00813192A CN 1376042 A CN1376042 A CN 1376042A
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Abstract
本发明涉及一种用于人眼的药物释放装置。人眼有一个巩膜、一块下斜肌和一个黄斑。本发明的该装置包括一种药物活性药剂,和一种几何形状,该几何形状便于将该装置植入到巩膜的一个外表面上,在该下斜肌以下,并且将药物活性药剂配置到黄斑之上。同时还揭示了将药物活性药剂释放到人眼后部的方法。
Description
本申请要求系列号为60/160,673、申请日为1999年十月二十一日、名称为“药物释放装置”的美国临时申请的权益,该临时申请已包括在本说明书中。
技术领域
本发明一般涉及用于局部释放药物活性药剂到机体组织中有生物适应性的植入物。更具体但不构成限制的是,本发明涉及用于局部释放药物活性药剂到眼后部有生物适应性的植入物。
背景技术
眼后部的几种疾病威胁着视力。与年龄相关的黄斑变性(ARMD)、脉络膜新血管形成(CNV)、视网膜病变(如糖尿病性视网膜病变、玻璃体视网膜病变)、视网膜炎(如巨细胞病毒性视网膜炎(CMV))、眼色素层炎、黄斑水肿、青光眼和神经病变是这些疾病的几个例子。
与年龄相关的黄斑变性(ARMD)是导致老年性视觉缺失的首要原因。ARMD攻击视觉中心并使其模糊,使得阅读、驾驶和其它细致的工作变得困难或不可能完成。单就美国来说每年就有约200,000新的ARMD病例发生。最近的估计显示超过75岁的人群中大约有百分之四十、超过60岁的人群中大约有百分之二十在某些程度上患了黄斑变性。“湿”的ARMD是最常见的产生视觉缺失的ARMD类型。在湿ARMD中,新形成的脉络膜血管(脉络膜新血管形成(CNV))渗出液体并且导致视网膜的损害逐渐加重。
对于ARMD中的特殊病例CNV,目前有三种治疗方法,(a)光焊接(b)使用血管生成抑制剂(c)光动力治疗。光焊接是治疗CNV的最普通的方法。然而,当CNV靠近中央凹时,光焊接会损伤视网膜,因而是不可行的。另外,在超过一定时间后,光焊接常常导致CNV复发。将抗血管形成的化合物以口服或胃肠外(非眼部)的给药作为一种对ARMD的系统治疗也在进行试验。然而,由于药物特有的代谢限制,系统给药常常给眼睛提供的是达不到治疗效果的药物浓度。因此,为了使眼内达到有效的药物浓度,需要或者采用不可接受的高剂量或采用重复的传统剂量。在眼周注射这些化合物通常导致药物迅速冲出,并且经眼周脉管系统和软组织滴流到总循环系统中。重复进行眼周注射可能会导致严重的、通常是致盲的并发症,比如视网膜脱落和眼内炎。光动力治疗是一种新技术,其长期效果仍然在很大程度上不为人所知。
为了防止与上述治疗相关的并发症,并且提供更好的眼科治疗,研究人员已经建议采用各种植入物,旨在对眼睛局部地释放抗血管生成化合物。授予Wong的美国专利第5,824,072号提示了一个不可生物降解的共聚物植入物,在该植入物中配置了药物活性药剂。该药物活性药剂通过植入物的共聚物体扩散到目标组织。该药物活性药剂包括治疗黄斑变性和糖尿病性视网膜病变的药物。该植入物基本上被放置在泪液中,在眼睛外表面的无血管区域,并且可以固定在结膜或巩膜中;在巩膜外层或巩膜内层一个无血管的区域之上;基本上在脉络膜空间上一个无血管的区域内,例如在睫状环或一个外科诱导的无血管区域;或者可直接与玻璃体连通。
授予Gwon等人的美国专利第5,476,511号揭示了一个放置在眼睛结膜之下的共聚物植入物。该植入物可以用来释放用于治疗ARMD的新血管抑制剂和用于治疗视网膜病变、视网膜炎的药物。药物活性药剂通过植入物的共聚物体进行扩散。
授予Ashton等人的美国专利第5,773,019号揭示了不可生物腐蚀的共聚物植入物,该植入物用来释放的某些药物,其中包括血管抑制类固醇和例如用于治疗眼色素层炎的环孢菌素。药物活性药剂也是通过植入物的共聚物体进行扩散的。
以上所述的所有植入物都需要进行仔细的设计和加工,以便通过共聚物体(即基体装置)或共聚物膜片(即储存装置)将药物活性药剂有控制地扩散到需要进行治疗的位置。药物从这些装置的释放分别依赖于基体或膜片的孔隙率和扩散特性。必须为每一种用于该装置的药物定制这些参数。结果,这些需求通常增加了这种植入物的复杂性和成本。
授予Peyman的美国专利第5,824,073号揭示了在眼内定位的压头。该压头有一个凸出的部分,用来压凹眼睛黄斑区之上的巩膜或对眼睛黄斑区之上的巩膜施加压力。该专利申请揭示了,这种压力增加了脉络膜充血和通过视网膜下新血管形成膜的血液流量,这又反过来增加了出血和视网膜下液体的累积。
因此,在有生物适应性的植入物领域需要一种可外科植入的眼药释放装置,该装置可以安全、有效、可控制速率地局部释放各种药物活性药剂。植入该装置的外科操作将是安全、简单、迅速的并且可以对门诊病人实施。理想地,该装置应该在制造上是方便和经济的。另外,由于它的多功能性,并且可以释放各种药物活性药剂,这种植入物也应该可以用于眼科门诊研究,以便释放为患者产生一种特殊身体状态的药物。在需要局部释放药物活性药剂到眼睛后部以抵抗ARMD、CNV、视网膜病变、视网膜炎、眼色素层炎、黄斑水肿、青光眼和神经病变的情况下,尤其需要这种眼药释放装置。
发明内容
本发明是关于用于人眼的药物释放装置。人眼有一个巩膜、一块下斜肌和一个黄斑。本发明的装置包括一种药物活性药剂,该装置的几何形状便于将该装置植入到巩膜的外表面、下斜肌之下,并且将药物活性药剂配置在黄斑之上。由于其独特的几何形状,对于需要局部释放药物活性药剂到眼后部,以便抵抗ARMD、CNV、视网膜病变、视网膜炎、眼色素层炎、黄斑水肿、青光眼和神经病变的情况,这种装置是特别有用的。
附图说明
为了更彻底地理解本发明及其更多的目的和优点,在以下参考附图所作的描述中进行了说明,其中:
图1显示了人眼的侧剖面图,和一个根据本发明植入到眼后部的眼药释放装置;
图2是图1中眼睛沿2-2线的横剖面详图;
图3是表示人眼在其位置上的三维示意图;
图4显示了部分地移去侧直肌后图3中的眼睛;
图5是一个表示人眼的前视图;
图6是一个表示人眼的后视图;
图7是根据本发明的第一优选实施例的人体右眼眼药释放装置的透视的、从眼眶处看的视图;
图8是在图7和图9中所示的、包括一块下斜肌匹配斜面的眼药释放装置的透视、从眼眶处看的视图;
图9是图7所示的眼药释放装置的透视、从巩膜处看的视图;
图10是用于本发明的眼药释放装置的椭圆形的药核或药片的透视图;
图11是用于本发明的眼药释放装置的两个匹配的、半椭圆形药核或药片的透视图;
图12是图7和图9所示的人体左眼眼药释放装置的透视、从眼眶处看的视图;
图13是在图12和图14中所示的、包括一块下斜肌匹配斜面的眼药释放装置的透视、从眼眶处看的视图;
图14是图7和图9中所示的人体左眼眼药释放装置的透视、从巩膜处看的视图;
图15是在图7和图9中所示的、包括该装置锥形纵向部分的眼药释放装置的透视、从眼眶处看的视图;
图16是图7和图9中所示眼药释放装置的缩短型式的透视、从眼眶处看的视图;
图17是图16所示的包括一块下斜肌匹配斜面的眼药释放装置的透视、从眼眶处看的视图;
图18是根据本发明的第二优选实施例的人体右眼眼药释放装置的透视、从眼眶处看的视图;
图19是图18所示的包括一块下斜肌匹配斜面的眼药释放装置的透视、从眼眶处看的视图;
图20是本发明的第三优选实施例的人体右眼眼药释放装置的透视、从眼眶处看的视图;和
图21是图20中所示的包括一块下斜肌匹配斜面的眼药释放装置的透视、从眼眶处看的视图。
具体实施方式
本发明的优选实施例及其优点可以通过参考附图1到图21得到最好的理解,其中相同的标记符号将用在各图中相同的或相对应的部件上。
图1到图6说明了对于理解本发明很重要的人眼的各部分。参见图1,其中示意地显示了人眼90。眼90有一个角膜92、一个晶状体93、玻璃体95、一个巩膜100、一个脉络膜99、一个视网膜97和一个视觉神经96。眼90通常被分为前部89和后部88。眼90的前部89包括眼90的在锯齿缘11前面的部分。眼90的后部88通常包括眼90在锯齿缘11后面的部分。视网膜97在靠近睫状环13的地方、在视神经乳头盘19的后面、以环绕的方式与脉络膜99实际相连。视网膜97有一个位于视神经乳头盘19侧面附近的黄斑98。在眼科中众所周知,黄斑98主要包括视网膜锥体,并且是视网膜97中视敏度最高的区域。一个眼球筋膜或眼球囊101配置在巩膜100上。结膜94盖住了边缘115(球状结膜)后面的眼球90的一个短区域,并且上折(上陷凹)或下折(下陷凹)来分别盖住上眼睑78和下眼睑79的内部区域。结膜94配置在眼球筋膜101的顶部。
如图1和2所示,并且如下面所要详细描述的那样,装置50最好直接配置在巩膜100的外表面上,在眼球筋膜101以下,以便治疗大多数的眼后部疾病。此外,为了治疗人类的ARMD和CNV,装置50最好直接配置在巩膜100的外表面上,在眼球筋膜101以下,并且使装置50的内核靠近黄斑98。
图3显示了在其眼眶112中的人体左眼90。如图3所见,下斜肌107在侧直肌105之下延伸。下斜肌107插入巩膜100的插入线107a位于侧直肌105的上边界之上。当然,人体右眼90中下斜肌的位置是图3中的人体左眼90的该位置的镜像。角膜92、结膜94、上部直肌103、下部直肌104、上部斜肌106和边缘115都显示在图3中。
图4类似地显示了在其眼眶112中的人体左眼90。然而,侧直肌105的一部分在图4中没有显示,以便使通常被肌肉隐藏起来的巩膜100和视觉神经96成为可见的。在图4中,下斜肌107插入巩膜100的一条插入线107b比图3中所示的插入线107a低,这显示了在人眼中下斜肌的插入线的典型的生理变化。
图5示意性地显示了一个人眼90带着其四块直肌的前视图,即上直肌103、中间直肌108、下直肌104和侧直肌105。图5还显示了在图5中由边界线115表示的边缘,和由图5中的边界线113表示的直肌的插入线。
在图6中示意性地显示了人眼90的后视图。图6显示了上直肌103、侧直肌105、下直肌104、中间直肌108、上斜肌106、下斜肌107和其插入线107a、视觉神经96、睫状管109、巩膜100、在黄斑98上面的巩膜区域110、长睫状动脉111和涡状静脉114的位置。
图7和图9示意性地显示了根据本发明第一优选实施例的人体右眼眼药释放装置50。装置50可以用于任何需要将药物活性药剂局部释放到眼中的情况。装置50特别适用于需要将药物活性药剂局部释放到眼睛后部的情况。装置50的一个优选的应用是为了治疗ARMD、视网膜新血管形成(CNV)、视网膜病变、视网膜炎、眼色素层炎、黄斑水肿、青光眼和神经病变而将药物活性药剂释放到视网膜上靠近黄斑的区域中。
装置50通常包括基体21,该基体21有一个凸的、圆顶形的眼眶表面12和一个凹的、圆顶形的巩膜表面14。所设计的巩膜表面14的弯曲半径便于它与巩膜100直接接触。更好是使巩膜表面14的弯曲半径等于平常人眼90的弯曲半径91。(见图1)眼眶表面12最好被设计成具有便于植入眼球筋膜101以下的弯曲半径。当从上面看时,基体21最好有一个大概为“F-形”的几何形状,其中有纵向部分15、横向部分18和其间的弯曲部分32。纵向部分15和横向部分18最好在弯曲部分32处相连,以形成一个约为九十度的角度。纵向部分15有一个近端25、一个圆形边缘24、一个止动部分36和一个缺口42。正如以下将要详细描述的那样,缺口42被设计用来容纳下斜肌107的起始端部。止动部分36确定了缺口42的下部并且最好比通常是凸起的眼眶表面12的其余部分稍微升高一些。如下面将要详细所述的那样,止动部分36通过与下斜肌107的前边界相接触,防止装置50向视觉神经96过分前移。横向部分18有一个远端58、一个圆形边缘28和一个在巩膜表面14上有开口64的槽或空腔20。槽20和开口64最好为椭圆形。如下将要详细说明的那样,横向部分18可以使空腔20直接放置在巩膜100上的与黄斑98重叠的区域。
在图10中所示的内核81最好布置在槽20中。如图10所示,内核81最好是一个包括一种或多种药物活性药剂的药片。药片81最好具有椭圆形的基体46,该基体46具有凹的、圆顶形的巩膜表面85和凸的、圆顶形的眼眶表面86。基体46上还最好配置一个周边的斜角87。另外,如图11所示,内核也可以包括匹配的、半椭圆形的药片82a和82b。药片82a最好有与药片81的基体46的一半相同的基体47。药片82b最好有与药片81的基体46的另一半相同的基体48。另外,内核81或内核82a和82b也可以包括一种传统的水凝胶、胶、膏或其它半固体帛剂,在该制剂中有一种或多种药物活性药剂。
回到图9,保持零件62最好配置在开口64的附近。保持零件62防止内核81掉出槽20。当内核81是一个药片时,保持零件62最好是一个配置在开口64周边的连续的框或凸缘,该零件设计用来容纳药片81的斜边87。另外,保持零件62还可以包括一个或多个从基体21延伸到开口64中的零件。
虽然在图9和11中没有显示出,但内核81也可以包括一种悬浊液、溶液、粉末或其混合物,其中包含了药物活性药剂。在本实施例中,巩膜表面14上没有开口64,而悬浊液、溶液、粉末或其混合物通过在内核81以下的相对薄的巩膜表面14或其它膜扩散。另外,装置50还可以不带槽20或内核81,而以悬浊液、溶液、粉末或其混合物形式存在的药物活性药剂散布在装置50的整个基体21中。在此实施例中,药物活性药剂通过基体21扩散到目标组织中。
装置50的几何形状和尺寸最大限度地连通了内核81中的药物活性药剂和在巩膜表面14以下的目标组织。巩膜表面14最好实际上接触到巩膜100的外表面。另外,巩膜表面14也可以靠近巩膜100的外表面。例如,装置50可以配置在正好在巩膜100外表面之上的眼周组织中,或者在巩膜100中的薄层内。
基体21包括一种有生物适应性的、不可生物腐蚀的材料。基体21最好包括一种有生物适应性的、不可生物腐蚀共聚物成份。所述共聚物成份可以是一种单共聚物、一种直链、支链、交连或混合的共聚物。适合用于所述共聚物成份的共聚物例子包括硅氧烷、聚乙烯醇、乙烯醋酸乙烯酯、聚乳酸、尼龙、聚丙烯、聚碳酸酯、纤维素、醋酸纤维素酯、聚乙二醇酸、聚乳-乙二醇酸、纤维素酯、聚醚砜、丙烯、上述成份的衍生物及其混合物。适合的软丙烯的例子在美国专利第5,403,901中有更全面的揭示,该专利已整个包括在本文中。所述共聚物成份最好包括硅氧烷。当然,所述共聚物成份还可以包括影响其物理性质的传统材料,其中所述物理性质不构成限制地包括孔隙率、弯曲度、渗透性、刚性、硬度和光滑性。影响这些性质中的其中之一的材料的例子包括传统的可塑剂、填料和润滑剂。所述共聚物成份可以包括其它影响其化学性质的材料,其中的化学性质不构成限制地包括毒性、疏水性和基体21-内核81的相互作用。基体21最好对于内核81中的药物活性药剂来说是不可渗透的。当基体21由一般的弹性共聚成份制成时,可以使槽20的形状稍微小于内核81的形状。这种磨擦配合将内核81固定在槽20中。在此实施例中,如果要求的话,基体21可以带有或不带保持零件62,内核81可以带有或不带斜边87。
内核81可以包括任何眼部可接受的药物活性药剂,以便进行局部释放。适合于内核81的药物活性药剂的例子是抗感染药,不构成限制地包括抗生素、抗病毒药、抗真菌药、抗过敏原的药和乳突细胞稳定剂;类固醇和非类固醇的抗炎药;环氧合酶抑制剂,不构成限制地包括Cox I和Cox II抑制剂;抗感染药和抗炎药的混合物;抗青光眼药,不构成限制地包括肾上腺素能剂、β-肾上腺素能阻滞剂、α-肾上腺素能促效药、拟副交感剂、胆碱酯酶抑制剂、碳酸酐酶抑制剂和前列腺素;抗青光眼药的混合物;抗氧化剂;营养供给剂;用于治疗囊样黄斑水肿的药物不构成限制地包括非类固醇抗炎药;用于治疗ARMD的药物不构成限制地包括血管生成抑制剂和营养供给剂;用于治疗疱疹感染和CMV眼部感染的药物;用于治疗增生性玻璃体视网膜病变的药物不构成限制地包括抗代谢剂和溶解纤维蛋白;创伤调节药物不构成限制地包括生长素;抗代谢剂;神经保护药物不构成限制地包括eliprodil;和用于治疗眼后部疾病的血管抑制类固醇,这些眼后部疾病不构成限制地包括ARMD、CNV、视网膜病变、视网膜炎、眼色素层炎、黄斑水肿和青光眼。这种血管抑制类固醇更完全地揭示于美国专利第5,679,666和第5,770,592号中,这些专利均已完全包括在本文中。这种血管抑制类固醇的较优的种类包括4,9(11)-孕双烯-17α,21-二醇-3,20-二酮(4,9(11)-Pregnadien-17α,21-diol-3,20-dione)和4,9(11)-孕双烯-17α,21-二醇-3,20-二酮-21醋酸酯(4,9(11)-Pregnadien-17α,21-diol-3,20-dione-21-acetate)。一种优选的用于治疗囊样黄斑水肿的非类固醇抗炎剂是nepafenac。内核81还可以包括传统的非活性的赋形剂以加强活性药剂或药核的稳定性、溶解性、渗透性或其它特性。
如果内核81是一个药片,它还可以包括传统的制药片需要用的赋形剂,如填料和润滑剂。这种药片可以用传统的制药片方法来生产。药物活性药剂最好均匀地分布在整个药片中。除了传统的药片之外,内核81还可以包括一种以控制的速率被生物腐蚀的特殊药片,来释放药物活性药剂。例如,这种生物腐蚀可通过水解或酶分裂产生。如果内核81是一种水凝胶或其它的胶,这种胶会以控制的速率进行生物腐蚀,并且释放出药物活性药剂。另外,这种胶还可以是非生物腐蚀的,但可以扩散药物活性药剂。
装置50可以采用传统的共聚物生产方法来制造,这些方法不构成限制地包括注射模塑、压挤模塑、传递模塑和压塑。最好,装置50采用传统的注射模塑技术形成。内核81最好在装置50的基体21形成之后配置到槽20中。保持零件62最好具有足够的弹性,以便让内核81的斜边87插入开口64中并且随后恢复到其原来位置。
装置50最好通过手术直接放置到巩膜100的外表面上,在眼球筋膜101之下,并且使槽20和内核81直接处于黄斑98之上的巩膜100的区域上,其所采用的是以下优选的可用于门诊病人的技术。外科医生首先在眼90的一个四分体上进行一个8毫米的球结膜环状切开术。最好,外科医生在颞下的四分体上、在眼90的边缘115之后3毫米处进行这种球结膜环状切开术。一旦形成切口,外科医生就进行一个钝器解剖术以便将眼球筋膜101从巩膜100上分离。采用剪刀或钝器分离术,在巩膜100的外表面在下斜肌107以下处,最好是顺着侧直肌105的下边缘,在前后方向上形成一个通道。然后让下斜肌107与Jamison肌肉钩结合。然后将该肌肉钩前移到下斜肌的后面以形成将容纳装置50的横向部分18的通道的一部分。一旦该通道形成,外科医生使用Nuggett钳来夹持装置50的横向部分18,使巩膜表面14对着巩膜100,而横向部分18的远端58远离外科医生。然后外科医生将把远端58放在前面,在球结膜环状切开术所在层面内将装置50导入该通道。一旦进入通道,外科医生顺着该通道向着下斜肌107前移装置50,直到止动部分36接触到下斜肌107的前边界。在可见的下斜肌107的层面内,外科医生在肌肉107以下转动装置50,这样装置50的横向部分18进入到通道正好在下斜肌107之后的部分。当外科医生感到弯曲部分32不能再向前移时,外科医生就在前后方向上稍微移动装置50,以便让下斜肌107容纳于在横向部分18和止动部分36之间的缺口42中。由于缺口42和槽20的位置靠近横向部分18的远端58,内核81被放置在巩膜100上直接处于黄斑98之上的区域。然后将纵向部分15的近端25缝合到巩膜100上。外科医生然后通过将眼球筋膜101和结膜94缝合到巩膜100上来关闭球结膜环状切口。关闭之后,外科医生将一个抗生素软膏条放置到外科创口上。所有的缝合最好采用7-0Vicryl缝合。对于治疗ARMD和CNV来说,内核81中的药物活性药剂最好是美国专利第5,679,666号和第5,770,592号中所揭示的血管抑制类固醇中的一种。
装置50的基体21的几何形状包括巩膜表面14的凹陷特性;横向部分18、槽20、开口64、内核81和保持零件62的形状和位置;以及缺口42和止动部分36的形状和位置,都是有利于从内核81中通过巩膜100、脉络膜99到视网膜97中特别是黄斑98中释放有药效剂量的药物活性药剂。在槽20和巩膜100之间不设共聚物层或膜,将大大有利于加强和简化将一种活性药剂向视网膜97的释放。
据信,根据所采用的药物活性药剂的具体物理化学特性,装置50可以用来长年向视网膜97释放有药效剂量的药物活性药剂。植入物的物理化学特性包括疏水性、溶解性、溶解速率、扩散系数、分配系数和组织亲和性。在内核20不再含有活性药剂后,外科医生可以很容易地将装置50移走。另外,“以前形成”的通道便于用一个新装置50来替换旧的装置50。
图8显示了一个眼药释放装置60,它对眼药释放装置50稍微作了一些改进,这些改进有利于一些本发明的植入。如图8所示,装置60与图7和图9中所示的装置50的几何形状基本相似,其不同之处在于在基体21的眼眶表面12上靠近缺口42的地方增加了一个弯坡45。弯坡45是一个倾斜表面,该倾斜表面最好从其第一端的巩膜表面14处延伸到第二端的眼眶表面12处。另外,弯坡45还可以从其第一端的纵向部分15的圆形边缘24处延伸到其第二端的眼眶表面12处。如上所述,当装置60被植入眼90中时,弯坡45有利于在缺口42中容纳下斜肌107,其中缺口42中处在横向部分18和止动部分36之间。装置60可以采用与装置50基本类似的技术来制造。
图12和14示意性地显示了用于人体左眼的眼药释放装置70。装置70的几何形状是用于人体右眼的根据图7和9所述的装置50的几何形状的镜像。装置70的应用基本上与装置50的应用相同,装置70可以采用与装置50基本类似的技术来制造。
图13显示的是一个用于人体左眼的眼药释放装置75,其中对眼药释放装置70稍微作了一些改进,这些改进有利于一些本发明的植入。图13的装置75的几何形状与图8中的装置60的几何形状基本类似,不同之处在于装置75是装置60的镜像。
图15显示了一个眼药释放装置30,它对眼药释放装置50稍微作了一些改进,这些改进有利于一些本发明的植入。如图15所示,装置30与图7和图9中所示的装置50的几何形状基本相似,其不同之处在于当从边缘24处看时,纵向部分15有逐渐变小的厚度,该逐渐变小厚度的部分开始于位置33处并且延续到近端25处。纵向部分15的该部分配置在眼的前部并且可以被其它人看见。因此,由于这种逐渐变小的厚度,装置30可能变得更舒服,并且在美容方便更容易让患者接受。装置30的应用基本上与装置50的应用相同,装置30可以采用与装置50基本类似的技术来制造。
图16显示了一个眼药释放装置40,它对眼药释放装置50稍微作了一些改进,这些改进有利于一些本发明的植入。如图16所示,装置40与图7和图9中所示的装置50的几何形状基本相似,其不同之处在于装置40的纵向部分15的长度相对于装置50来说被缩短了。与装置30类似,这种纵向部分15的缩短,使得装置40变得更舒服,并且在美容方便更容易让患者接受。装置40的应用基本上与装置50的应用相同,装置40可以采用与装置50基本类似的技术来制造。
图17显示了一个眼药释放装置80,它对眼药释放装置40稍微作了一些改进,这些改进有利于一些本发明的植入。如图17所示,装置80与图16中所示的装置40的几何形状基本相似,其不同之处在于在基体21的眼眶表面12上靠近缺口42的地方增加了一个弯坡45。弯坡45是一个倾斜表面,该倾斜表面最好从其第一端的巩膜表面14处延伸到第二端的眼眶表面12处。另外,弯坡45还可以从其第一端的纵向部分15的边缘24上一点处延伸到其第二端的眼眶表面12处。如以上根据装置50所述,当装置80被植入眼90中时,弯坡45有利于在缺口42中容纳下斜肌107,其中缺口42中处在横向部分18和止动部分36之间。装置80可以采用与装置50基本类似的技术来制造。
图18示意性地显示了根据本发明第二优选实施例的、用于人体右眼的眼药释放装置65。装置65可以用在任何需要采用局部释放药物活性药剂给眼睛的情况。装置65特别适应于将活性药剂释放到眼后部的情况。装置65的一个优选的应用是将药物活性药剂释放到靠近黄斑的视网膜上,以便治疗ARMD、脉络膜新血管形成(CNV)、视网膜病变、视网膜炎、眼色素层炎、黄斑水肿、青光眼和神经病变。
装置65通常包括基体29,该基体29有一个凸的、圆顶形的眼眶表面12和一个凹的、圆顶形的巩膜表面14(没有显示)。所设计的巩膜表面14的弯曲半径便于它与巩膜100直接接触。更好是使巩膜表面14的弯曲半径等于平常人眼90的弯曲半径91。眼眶表面12最好被设计成具有便于植入到眼球筋膜101以下的弯曲半径。当从上面看时,基体21最好有一个大概为“C-形”的几何形状,其中有纵向部分17、横向部分18和其间的弯曲部分32。纵向部分17和横向部分18最好在弯曲部分32处相连,以形成一个约为九十度的角度。纵向部分17有一个近端25、一个圆形边缘24。一个止动部分37形成了C形的“下”部并且该止动部分最好比通常凸起的眼眶表面12的其余部分升高一些。一个缺口42位于纵向部分17处,并且由横向部分18和止动部分37所确定。与图7和图9所示的装置50的缺口42类似,装置65的缺口42被设计用来容纳下斜肌107的起始端部。与装置50的止动部分36类似,止动部分37通过与下斜肌107的前边界相接触,防止装置65向视觉神经96过分前移。横向部分18有一个远端58、一个圆形边缘28和一个在巩膜表面14(没有显示)上有开口64(没有显示)的槽或空腔20,以便夹持住与以上根据图10和图11所描述的内核相似的内核。槽20和开口64最好大概为椭圆形。
装置65的应用基本上与上述装置50的应用相同。装置65可以采用与装置50基本类似的技术来制造。
图19显示了一个眼药释放装置67,它对眼药释放装置65稍微作了一些改进,这些改进有利于一些本发明的植入。如图19所示,装置67与图19中所示的装置65的几何形状基本相似,其不同之处在于在基体29的眼眶表面12上靠近缺口42的地方增加了一个弯坡45。弯坡45是一个倾斜表面,该倾斜表面最好从其第一端的巩膜表面14处延伸到第二端的眼眶表面12处。另外,弯坡45还可以从其第一端的纵向部分17的边缘24上一点处延伸到其第二端的眼眶表面12处。如以上根据装置50所述,当装置67被植入眼90中时,弯坡45有利于在缺口42中容纳下斜肌107,其中缺口42处在横向部分18和止动部分37之间。装置67可以采用与装置50基本类似的技术来制造。
图20示意性地显示了根据本发明的第三优选实施例的、用于人体右眼的眼药释放装置52。装置65可以用在任何需要采用局部释放药物活性药剂给眼睛的情况。装置65特别适应于将活性药剂释放到眼后部的情况。装置65的一个优选的应用是将药物活性药剂释放到靠近黄斑的视网膜上,以便治疗ARMD、脉络膜新血管形成(CNV)、视网膜病变、视网膜炎、眼色素层炎、黄斑水肿、青光眼和神经病变。
装置52通常包括基体39,该基体39有一个凸的、圆顶形的眼眶表面12和一个凹的、圆顶形的巩膜表面14(没有显示)。所设计的巩膜表面14的弯曲半径便于它与巩膜100直接接触。更好是使巩膜表面14的弯曲半径等于平常人眼90的弯曲半径91。眼眶表面12最好被设计成具有便于植入到眼球筋膜101以下的弯曲半径。当从上面看时,基体39最好有一个大概为“L-形”的几何形状,其中有纵向部分15、横向部分18和其间的弯曲部分32。纵向部分15和横向部分18最好在弯曲部分32处相连,以形成一个约为九十度的角度。与图7和图9的装置50的缺口42相似,装置52的区域43被设计用来容纳下斜肌107的起始端。纵向部分15有一个近端25、一个圆形边缘24。横向部分18有一个远端58、一个圆形边缘28和一个在巩膜表面14上有开口64(没有显示)的槽或空腔20,以便夹持住与以上根据图10和图11所描述的内核相似的内核。槽20和开口64最好为椭圆形。
装置52的应用基本上与上述装置50的应用相同,装置52可以采用与装置50基本类似的技术来制造。
图21显示了一个眼药释放装置54,它对眼药释放装置52稍微作了一些改进,这些改进有利于一些本发明的植入。如图21所示,装置54与图20中所示的装置52的几何形状基本相似,其不同之处在于在基体29的眼眶表面12上靠近区域43的地方增加了一个弯坡45。弯坡45是一个倾斜表面,该倾斜表面最好从其第一端的巩膜表面14处延伸到第二端的眼眶表面12处。另外,弯坡45还可以从其第一端的纵向部分15的边缘24上一点处延伸到其第二端的眼眶表面12处。如以上根据装置50所述,当装置54被植入眼90中时,弯坡45有利于在区域43中容纳下斜肌107。装置54可以采用与装置50基本类似的技术来制造。
由上所述,可以体会到本发明提供了改进的装置和方法,以便安全、有效、控制速率地局部释放各种药物活性药剂给眼睛,特别是给眼睛后部,以抵抗ARMD、CNV、视网膜病变、视网膜炎、眼色素层炎、黄斑水肿、青光眼和神经病变。植入该装置的外科操作是安全、简便、迅速并且可以给门诊患者实施。这种装置在制造上也是方便和经济的。另外,因为它们能够释放各种药物活性药剂,这些装置在临床研究中可用于释放各种眼药以便为患者产生一种特殊的身体状态。
本发明在此是通过实施例说明的,对于本领域内的技术人员来说可以进行各种不同的改进。例如,虽然上述的本发明涉及一种从顶部看具有“F-形”,“C-形”,或“L-形”几何形状的眼药释放装置,但也可以采用其它的几何形状,特别是当该装置被植入到人眼的巩膜外表面上以及眼球筋膜之下时,所采用的几何形状有利于该装置被植入到下斜肌以下并且使药物活性药剂在黄斑之上时尤其如此。
可以相信本发明的操作和结构将从以上描述中变得显而易见。在以上所显示和描述的设备和方法已经被作为优选实施例加以说明的同时,各种变形和改进都可以在不脱离以下的权利要求所确定的本发明的实质和范围的条件下实行。
Claims (35)
1.一种用于人眼的药物释放装置,所述眼有一个巩膜、一块下斜肌和一个黄斑,所述装置包括:
一种药物活性药剂;和
一个几何形状,该几何形状有利于将所述装置植入到所述巩膜的一个外表面上,在所述下斜肌的下面,并且所述药物活性药剂配置在所述黄斑之上。
2.根据权利要求1的药物释放装置,其特征在于:所述几何形状是一个大概为F-形的几何形状。
3.根据权利要求1的药物释放装置,其特征在于:所述几何形状是一个大概为C-形的几何形状。
4.根据权利要求1的药物释放装置,其特征在于:所述几何形状是一个大概为L-形的几何形状。
5.根据权利要求1的药物释放装置,还包括:
一个具有巩膜表面和一条槽的基体,所述巩膜表面用来放置到所述巩膜的所述外表面上,所述槽具有一个在所述巩膜上的开口;和
一个内核,该内核配置在所述槽中,并且包括所述药物活性药剂。
6.根据权利要求5的药物释放装置,其特征在于:所述基体包括一种有生物适应性的、不可生物腐蚀的材料。
7.根据权利要求5的药物释放装置,其特征在于:所述基体包括一种共聚物成份。
8.根据权利要求7的药物释放装置,其特征在于:所述共聚物成份包括一种或多种共聚物,这些共聚物是从由硅氧烷、聚乙烯醇、乙烯醋酸乙烯酯、聚乳酸、尼龙、聚丙烯、聚碳酸酯、纤维素、醋酸纤维素酯、聚乙二醇酸、聚乳-乙二醇酸、纤维素酯、聚醚砜和丙烯组成的材料组中选择出来的。
9.根据权利要求8的药物释放装置,其特征在于:所述共聚物成份包括硅氧烷。
10.根据权利要求5的药物释放装置,其特征在于:所述基体对于所述药物活性药剂是不可渗透的。
11.根据权利要求5的药物释放装置,其特征在于:所述内核是一种药片。
12.根据权利要求5的药物释放装置,其特征在于:所述内核包括一种半固体的结构,并且所述药物活性药剂被配置在所述半固体结构中。
13.根据权利要求5的药物释放装置,其特征在于:所述人眼包括一个眼球筋膜,所述基体包括一个眼眶表面,该眼眶表面的弯曲半径便于进行所述装置到所述眼球筋膜的所述植入。
14.根据权利要求1的药物释放装置,其特征在于:所述巩膜的弯曲半径基本上等于所述人眼的弯曲半径。
15.根据权利要求1的药物释放装置,其特征在于:所述药物活性药剂是nepafenac。
16.根据权利要求1的药物释放装置,其特征在于:所述药物活性药剂包括一种化合物,该化合物是从4,9(11)-孕双烯-17α,21-二醇-3,20-二酮(4,9(11)-Pregnadien-17α,21-diol-3,20-dione)和4,9(11)-孕双烯-17α,21-二醇-3,20-二酮-21醋酸酯(4,9(11)-Pregnadien-17α,21-diol-3,20--21-acetate)中选择出来的。
17.根据权利要求1的药物释放装置,其特征在于:所述药物活性药剂包括eliprodil。
18.根据权利要求5的药物释放装置,其特征在于:还包括一个从所述基体延伸到所述开口附近的保持零件。
19.根据权利要求5的药物释放装置,其特征在于:所述基体还包括一个缺口,在进行所述装置的所述植入时,所述缺口便于容纳所述下斜肌。
20.根据权利要求19的药物释放装置,其特征在于:所述缺口包括一个斜坡。
21.一种向人眼释放药物活性药剂的方法,所述人眼有一个巩膜、一块下斜肌和一个黄斑,包括步骤:
提供一种包括一种药物活性药剂的药物释放装置;和
将所述装置放置在所述巩膜的一个外表面上,在所述下斜肌以下,并且将所述药物活性药剂配置在所述黄斑之上。
22.根据权利要求21的方法,其特征在于:所述的配置步骤包括将所述装置配置到所述人眼的一个眼球筋膜之下。
23.根据权利要求21的方法,其特征在于:所述药物释放装置还包括:
一个具有巩膜表面和一条槽的基体,该巩膜表面用来放置到所述巩膜的所述外表面上,该槽具有一个在所述巩膜上的开口;和
一个内核,该内核配置在所述槽中,并且包括所述的药物活性药剂。
24.根据权利要求23的方法,其特征在于:所述基体包括一种有生物适应性的、不可生物腐蚀的材料。
25.根据权利要求23的方法,其特征在于:所述内核是一种药片。
26.根据权利要求23的方法,其特征在于:所述内核包括一种半固体的结构,并且所述药物活性药剂被配置在所述半固体的结构中。
27.根据权利要求23的方法,其特征在于:所述基体对于药物活性药剂是不可渗透的。
28.根据权利要求23的方法,其特征在于:所述巩膜表面的弯曲半径等于所述人眼的弯曲半径。
29.根据权利要求21的方法,其特征在于:所述药物活性药剂包括一种化合物,该化合物是从4,9(11)-孕双烯-17α,21-二醇-3,20-二酮(4,9(11)-Pregnadien-17α,21-diol-3,20-dione)和4,9(11)-孕双烯-17α,21-二醇-3,20-二酮-21醋酸酯(4,9(11)-Pregnadien-17α,21-diol-3,20--21-acetate)中选择出来的。
30.根据权利要求21的方法,其特征在于:所述药物活性药剂包括eliprodil。
31.根据权利要求23的方法,其特征在于:所述基体包括一个缺口,并且其中的配置步骤包括将所述下斜肌在巩膜的一侧配置到所述缺口中。
32.根据权利要求21的方法,其特征在于:所述装置有一个大体上为F-形的几何形状。
33.根据权利要求21的方法,其特征在于:所述装置有一个大体上为C-形的几何形状。
34.根据权利要求21的方法,其特征在于:所述装置有一个大体上为L-形的几何形状。
35.根据权利要求21的方法,其特征在于:所述药物活性药剂是nepafenac。
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US09/664,790 | 2000-09-19 | ||
US09/664,790 US6416777B1 (en) | 1999-10-21 | 2000-09-19 | Ophthalmic drug delivery device |
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CN100428958C (zh) * | 2004-09-06 | 2008-10-29 | 段亚东 | 一种治疗眼病的植入剂 |
CN105997338A (zh) * | 2016-03-09 | 2016-10-12 | 泰山医学院 | 经玻璃体纳米材料给药系统 |
CN105997338B (zh) * | 2016-03-09 | 2019-04-26 | 泰山医学院 | 经玻璃体纳米材料给药系统 |
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