CN103957965B - 用于药物递送装置的药剂导向组件 - Google Patents
用于药物递送装置的药剂导向组件 Download PDFInfo
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- CN103957965B CN103957965B CN201280056398.XA CN201280056398A CN103957965B CN 103957965 B CN103957965 B CN 103957965B CN 201280056398 A CN201280056398 A CN 201280056398A CN 103957965 B CN103957965 B CN 103957965B
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Abstract
本发明涉及制造用于药物递送装置的流体导向组件的方法及相应流体导向组件。所述方法包括如下步骤:提供第一构件(12),其具有位于第一表面部分(22)中的至少一个凹部(16,18);用至少部分地从第一构件(12)的第一表面部分(22)突出的结合部件(26)至少部分地填充凹部(16,18);将具有第二表面部分(24)的第二构件(20)布置为邻近第一构件(12),以便其第一和第二表面部分(22,24)向着彼此以形成第一和第二构件(12,20)间的界面区域(15),其中结合部件包括与第一和/或第二构件(12,20)的材料不同的材料,沿界面区域(15)延伸的至少一个通道结构(13)由第一构件(12)的和/或第二构件(20)的至少一个加深部(14)形成,选择性地提供热能到结合部件(26)以将第一和第二构件(12,20)连结在一起。
Description
技术领域
本发明涉及用于药物递送装置的流体导向组件,其提供适于引导流体例如药剂的至少一个流体通道。本发明另外涉及这种流体导向组件的制造方法。
背景技术
用于设定和分配单剂量或多剂量的液体药剂的药物递送装置在本领域中已被熟知。一般地,这种装置具有与普通注射器的目的大致类似的目的。
药物递送装置、具体地笔式注射器必须满足若干用户特殊要求。例如,对于困扰患者的慢性病,象糖尿病这类的,患者可能身体虚弱或者也可能具有受损的视力。尤其地为家用给药设计的合适药物递送装置因此需要在构造上可靠且应该易于使用。此外,装置及其部件的操作以及总体上的操纵应该是易懂的并且容易明白。而且,剂量设定以及剂量分配过程必须易于操作并且必需是明确的。
例如,这样的装置包括壳体,所述壳体用以接收用待分配的药剂至少部分地填充的药筒。装置还包括驱动机构,该驱动机构典型地具有可移位的活塞杆以与药筒的活塞操作接合。借助于驱动机构及其活塞杆,药筒的活塞能够在远端方向或分配方向上移位,并且因此可以经由穿透组件排出预定量的药剂,穿透组件与药物递送装置的壳体的远端或者分配端可释放地相联。
依据药剂类型以及在给药到患者之前制备药剂必需的方式,特定的药物递送装置必须提供药剂导向结构,例如位于药筒下游但是在分配端上游。该流体导向结构或者流体导向通道的制造是较为重要的。特别地在流体导向结构由塑料制成时,具体地由热塑料材料制成时,难以实现流体导向结构或者通道结构的所需小型化。例如通过注射模制过程,复杂的或者多圈中空通道结构不能实现。
尤其地,对于药物递送装置及应用,特别有益的是提供具有较小横截面的流体导向通道以使得流体导向结构的死区最小化,以不会不必要地浪费要被引导从中通过的宝贵或者昂贵的药剂或类似物质。
而且,流体导向塑料部件应该对于其所引导的药剂或者物质是基本上不起化学作用或者高度相容的。因此,适于药剂导向的塑料部件的范围是相当受限的。
总体上,小尺寸的通道结构能够通过提供具有横过表面部分延伸的通道形成槽或者凹部的特征的构件来制成。通过用盖部覆盖表面部分以及通过将盖部和所述构件连结在一起,在原理上能够提供闭合的流体导向通道结构。构件和盖部的连结可以经由激光焊接或者超声波焊接以及通过使用粘合剂来提供。构件与盖部的这种彼此连结涉及到施加热,这最终会使得相应塑料材料的化学惰性特性劣化。
另外,化学惰性的塑料材料由于不足的光吸收特性而相当地不适合用于例如激光焊接。光吸收的提高在原理上能够通过将吸光颗粒、诸如灰粒嵌入到这种塑料材料的体积中来实现。但是,这会另外使得塑料材料的纯度劣化,并且预先规定的以及所需的化学惰性特性不再会被满足。
另外,当借助于粘合剂将构件和盖部连结在一起时,粘合剂的一部分可侵入通道结构,由此增大了从中流过的药剂被污染的风险。
发明内容
发明目的
因此,本发明目的在于提供一种用于药物递送装置的流体导向组件,其易于组装并且提供了具有预定大小和/或几何结构的液密通道结构,而不需要对通道形成构件直接施加热能。因此,本发明旨在提供一种改进的在不使制成通道结构的塑料部件劣化的情况下制造流体导向组件的方法。所述制造方法应是高度可重现的,并且应在流体导向组件的塑料基构件或者零件中提供耐用的液密的流体导向通道结构。
发明概要
在第一方面,本发明提供了用于药物递送装置的流体导向组件的制造方法。在此,在第一步骤中,提供第一构件,该第一构件具有在第一表面部分中的至少一个凹部。在第二步骤中,所述凹部被至少部分地填充以结合部件,结合部件包括与制成第一构件的材料不同的材料。
此后,第二构件优选地布置在第一构件的顶部上以将结合部件相应地容纳在第一和第二构件之间。第二构件具有与第一构件的第一表面部分面对的第二表面部分。第二构件要被布置成邻近第一构件以便其第一和第二表面部分向着彼此以形成第一和第二构件之间的界面区域。
第一或者第二构件中的至少一个包括沿着第一和第二构件的界面区域延伸的至少一个通道结构。所述通道结构由分别在第一或者第二表面部分中延伸的至少一个加深部或者槽形成。通过所述加深部,沿着第一和第二表面部分的界面区域延伸的至少一个闭合通道结构能够通过使得第一和第二构件成彼此邻接构造而形成。
在将第一和第二构件相对于彼此相互布置之后,选择性地将热能提供到结合部件,以将第一和第二构件连结在一起。结合部件特别地适于响应于热能施加而熔融,这可以例如通过吸收预定光谱范围的电磁辐射而发生。
起始地并且在将热能施加到结合部件之前,结合部件至少部分地从第一构件的第一表面伸出。由此,第一和第二构件的第一和第二表面部分在热能施加之前能够相对于彼此保持一定距离。一旦结合部件响应于能量施加而熔融,则第一和第二构件能够建立彼此邻接构造,例如当承受压缩力时。
因此,根据另一实施例,热能通过吸收电磁辐射而被提供到结合部件中。由此,其中第一和第二构件以及结合部件被松散配合的预组装的流体导向组件暴露于电磁辐射。优选地,其暴露于由激光器发射的基本上单色的辐射。当所述辐***确地聚焦或者被空间上限制在结合部件延伸的区域中时,这是特别有用的。
结合部件的材料选择具体地与结合部件的吸收性能匹配。当第一和第二构件中的至少一个,优选地第一和第二构件两者,具有对于所选电磁辐射的较低吸收系数时,这是进一步有利的。
当根据另一实施例,第一和第二构件在热能施加到结合部件期间被按压在一起时,这是特别有益的。这样,第一和第二构件可以接受到最终的补偿运动,该补偿运动可以有助于分别补偿第一和第二构件的相互对应的表面部分的最终平面度公差。另外,通过使用适于对第一和/或第二构件施加压缩压力的若干施压件,第一和/或第二表面上的压力分布可以变得相当均匀。因此,实际上,通过施加相当均匀的压力,能够提高激光焊接过程的可靠性和可重复性。
在另一实施例中,第二构件包括在第二表面部分中的至少一个凹部。这一凹部的大小和位置对应于第一构件的第一表面部分中的至少一个凹部。当以相互邻接构造布置第一和第二构件时,设置在第一构件的凹部中的结合部件可以延伸到第二构件的凹部中。从第一表面延伸的结合部件因此可以提供组装辅助,用于以明确的(well-defined)相互邻接构造将第一和第二构件置于一起。借助于相互对应的凹部并且借助于被接收在其中的结合部件,第一和第二构件能够容易地相对于彼此定位、定向以及对准。
这里,甚至可以构思到,结合部件与第二构件的对应地形成的凹部摩擦接合或者积极(positive)接合,由此提供第一和第二构件的明确的预组装。
在另一优选实施例中,结合部件在分别与第一和第二构件的第一和/或第二表面部分的表面法线平行的方向上的延伸部基本上大于第一和第二构件的相互对应的凹部的相应深度之和。用这样方法将结合部件预组装在第一构件的至少一个凹部中以及将第二构件布置到第一构件,使得其凹部接收结合部件的突出的自由端,则第一和第二表面部分相对于彼此维持一定距离。仅在对结合部件施加热能以及熔融结合部件时,第一和第二构件的第一和第二表面部分才可直接相互接触。这里,结合部件的过量材料可以分布在第一和/或第二构件的相互对应的凹部中,或者甚至可以铺开和分布在第一和第二构件的界面区域中。
根据另一实施例,第二构件的凹部比第一构件的凹部宽。这样,结合部件能够例如摩擦接合在第一构件的凹部中或者能够以其它方式固定在第一构件的凹部中。假使结合部件包括与第一和/或第二表面部分的表面法线平行的连续且细长形状,则当第二构件处于相应的预组装位置时,在结合部件的突出部分与第二构件的凹部之间将形成横向间隙。第二构件的凹部的相应宽度允许将第二构件沿横向方向,即与第一和第二构件的第一和/或第二表面部分的平面平行的方向,布置在规定的公差范围内。这样,在第一和第二构件连结在一起之前,能够提供沿横向方向的彼此相对布置和对准。
在另一实施例中,第二构件的凹部与结合部件的横向延伸部相比在横向方向上更宽。以这种方法并且如上所述的,将结合部件接收在第二构件的凹部中允许第一和第二构件在横向方向上的相对彼此对准。
替代地,还可以构思到,结合部件被预组装在第二构件的至少一个凹部中,以使第一和第二构件以预组装构造被置于一起时,结合部件进入第一构件的对应凹部中。当第一和/或第二构件的、在第一和第二构件相互组装期间适合于接收结合部件的凹部的横向宽度或者直径大于要被接收在其中的结合部件的对应宽度、横截面或者直径时,这是特别有利的。
甚至可构思到,第一和第二构件包括至少两个单独的凹部,其中第一和第二构件两者中的至少一个凹部起始至少部分地被用结合部件填充,其中结合部件从相应的构件突出以进入到相应地另一构件的对应凹部中。
在另一实施例中,当结合部件熔融时,结合部件的过量材料延伸到在结合部件和第二构件的凹部之间的横向间隙中并填充该横向间隙。依据结合部件和第一和第二构件的相互对应的凹部的具体构造,还可构思到结合部件的过量材料填充位于结合部件和第一构件的对应凹部之间的横向间隙。
一般地,通过使结合部件至少部分地从第一构件的第一表面突出,能够实现具有密封用第二构件的预组装构造,其中能够获得相应的第一和第二构件的第一和第二表面之间的竖向间隙。在这一构造中,两个构件均与结合部件直接接触。将热能施加到结合部件则会导致所述结合部件的熔融,其中能够实现与第一和第二构件的接触。
另外,在重力或者压力作用下,正在熔融或者熔融后的结合部件可以均匀地分布在第一构件的至少一个凹部中或者分别地分布在第一和第二构件的相互对应且基本上重叠的凹部中。热引起的结合部件熔融还导致第一和第二表面之间的竖向间隙的减小。优选地,所述间隙在以电磁式方式引起结合部件熔融期间被完全闭合。因此,第一和第二构件的第一和第二表面部分之间的竖向间隙的大小可以直接指示结合部件的熔融以及第一和第二构件的相应连结的质量和进展。
因此,在另一优选实施例中,第一和第二表面部分之间的竖向间隙大小可用以控制结合部件中的能量吸收。从而,热能被提供到结合部件,优选地通过激光辐射的吸收来提供,直到第一和第二构件的第一和第二表面彼此以直接机械接触的方式相互邻接,由此提供对于沿着第一和第二构件的界面区域延伸的通道结构的有效密封。
在另一方面中,用于药物递送装置的流体导向组件通过如上所述的方法组装而被提供。流体导向组件包括第一构件,该第一构件具有在第一表面部分中的至少一个凹部。流体导向组件还包括与第一构件相邻地布置的第二构件。第二构件具有第二表面部分,所述第二表面部分面向第一构件的第一表面部分以形成第一和第二构件之间的界面区域,尤其是在变为直接相互接触时。从而,第一和第二构件的第一和第二表面向着彼此,并且甚至可以彼此直接接触或者直接邻接。
此外,流体导向组件包括沿着第一和第二构件的界面区域延伸的至少一个通道结构。该通道结构由提供在第一构件和/或在第二构件中的至少一个加深部或者槽形成。
具体地,该通道结构能够通过在例如第一构件的第一表面部分中形成槽以及通过借助于与第一构件成邻接构造的基本上平坦状或者相应地被制有槽沟或者被加深的第二构件覆盖所述槽来构造成。这样,能够在第一和第二构件的界面区域中形成通道结构,其中第一和第二构件的相互邻接的各表面部分横向地围住该通道结构。
典型地,第一和第二构件的第一和第二表面部分可以彼此补充,以提供沿着界面区域延伸并且在横向方向上由相互互联的第一和第二构件的表面轮廓包围的通道结构。
此外,为互连或者为连结第一和第二构件,设置在第一构件的第一表面部分中的所述至少一个凹部被用结合部件至少部分地填充,结合部件包括与第一和/或第二构件的材料不同的材料。结合部件优选地布置在所述凹部中,以使其与第一构件直接接触并且与布置成与结合部件和/或与第一构件机械接触的第二构件直接接触。优选地,结合部件完全地填充第一构件的凹部。
通过使用与第一和/或第二构件的材料不同的特定结合部件,第一和/或第二构件能够被一体地结合或者被粘合连结,而无需对其施加或者沉积热能。结合部件被夹在第一和第二构件之间,并且特别地适于施加热能以将第一和第二构件牢固地连结在一起。因此,不再要求对第一和/或第二构件施加热能。
实际上,优选用于制成第一和/或第二构件的生物相容或者化学惰性的塑料部件,不再必需针对例如基于热处理的连结步骤、如激光焊接而改动。通过在其间形成通道结构的那些构件之间设置单独的结合部件,能够有利地将例如激光焊接工艺期间第一和第二构件劣化的风险以及第一和/或第二构件的机械变形的风险最小化。
根据优选实施例,结合部件与第一和/或第二构件的材料相比具有针对预定光谱范围的电磁辐射的更大的吸收系数。结合部件可以根据可用电磁辐射源的光谱范围来选择。具体地,结合部件可以掺杂有特定染料或者掺杂有与预定光谱范围匹配的辐射吸收颗粒。
一般地,凹部和结合部件与通道结构的空间分开是特别有益的。因此,结合部件不必是生物相容或者符合FDA的类型。总体上,任何合适的材料或者物质能够用作结合部件,其响应于被暴露于选定光谱范围的电磁辐射而吸收热能。另外,结合部件在暴露于预定光谱范围的电磁辐射时,应承受熔融和连结作用。原理上,关于结合部件和电磁辐射的相应光谱范围的选择没有限制,只要结合部件对于电磁辐射表现出明显的吸收系数即可。但是,出于实践原因,光谱范围可以在电磁辐射的UV中、可见光谱内和/或近红外或远红外光谱中。
在另外优选的方面,流体导向组件的第一和/或第二构件对于预定光谱范围的电磁辐射是基本上透明的,或者非吸收性的。这样,热能能够被选择性地且精确地施加到夹在第一和第二构件之间的结合部件。由于第一和/或第二构件在预定光谱范围的电磁辐射中是基本上透明的,所以它们的吸收程度是较低的。因此,即使在预定光谱范围肉内,高密集的或者高度聚焦的电磁辐射也不会导致对第一和/或第二构件的显著加热。因此,构造有用于液体成分、具体地用于液体药物的液体导向通道结构的第一和第二构件可以保持基本上不受例如在激光焊接工艺中施加的电磁辐射的影响。
在优选的方面,第一和/或第二构件包括塑料材料并且可以通过注射模制形成。这样,第一和/或第二构件能够固有地设有沿着其特定表面部分延伸的凹部或者槽,以至少部分地形成通道结构,该通道结构通过使第一和第二构件相对于彼此直接邻接而闭合。第一构件和/或盖部优选地包括对于要被引导通过通道结构的物质基本上惰性的塑料材料。制成第一构件和盖构件的材料因此应该归类为生物相容的。优选地,第一构件和/或盖部包括经美国食品和药物管理局(FDA)批准的塑料材料。从而,选择的塑料材料满足根据美国政府法规(CFR)21的标准,并且被归类为符合FDA要求的。在符合FDA要求的塑料材料中,第一主体部和/或盖部可以包括诸如环烯烃聚合物(COP)的塑料材料。
在另一优选的方面,流体导向组件的第一和第二构件借助于选择性地施加热能到夹在第一和第二构件之间的结合部件而被连结在一起。优选地,能量施加通过吸收预定光谱范围的电磁辐射进行,该预定光谱范围与结合部件的光学吸收特性匹配。
优选地,能量施加、及由此的对电磁辐射暴露伴随着将第一和第二构件按压在一起。这样,在第一和第二构件的界面区域中形成的通道结构能够被有效密封,以提供流体密封性。
在此情况下,当第一和第二构件的第一和第二表面以直接机械接触构造相互邻接时,这是进一步有益的。这样,能够建立第一和第二构件的牢固互联,从而提供对于布置在其间的通道结构的液密密封。
在另一实施例中,第二构件横过第一构件的所述加深部延伸,以形成闭合的流体导向通道结构。在该示例中,其中通道形成用加深部的通道结构专门存在于第一构件中,第二构件可以充当盖子以闭合所述加深部并且形成围起的通道结构。在其中通道结构由第一和第二构件的两个相互对应的加深部或者槽来配套形成的其它构造中,同样由于第一和第二表面部分的相互邻接和直接机械接触,能够形成密封的通道结构。
另外,第二构件还横过第一表面部分的凹部延伸,以与结合部件直接机械接触。
在另一优选的方面,用以接收或者容纳结合部件的至少一个凹部布置在用以提供或者其旨在形成通道结构的所述加深部的空间范围之外。这样,承受热能施加的区域能够保持远离流体导向通道结构。实际上,第一和第二构件的与通道结构直接相邻的材料能够保持为基本上不受发生在第一构件的远侧凹部部分中的热能施加的影响。
在另一优选实施例中,至少两个凹部布置在界面区域的所述加深部的相反横向侧上。这样,第一和第二构件之间的一体结合或者粘合连结能够在第一和第二表面之上的多个部位形成,以提供第一和第二构件的基本上均匀的连结。
替代地,设置在第一构件中的单个或者多个凹部可以围起界面区域的空腔。因此,适于形成至少一个流体导向通道结构的所述加深部能够由适合于接收结合部件的凹部围住或者界定。这里,甚至可构思到一个或更多个凹部设置成相当同心的配置。
在另一优选实施例中,不仅第一构件具有凹部的构造,而且第二构件也包括至少一个凹部,该至少一个凹部对应于或者匹配第一构件的至少一个凹部。当结合部件从第一构件的表面部分明显伸出时,该实施例是特别有用的。优选地,结合部件在沿着第一和/或第二表面部分的表面法线的方向上的延伸大于相互对应的第一和第二凹部的深度之和。
这样,第一和第二构件在布置在彼此顶上时经由结合部件相互邻接,同时在第一和第二构件的第一和第二表面部分之间形成间隙。为将第一和第二构件连结在一起,热能将被提供到结合部件,结合部件响应于热能开始熔融。当结合部件的体积基本上匹配第一和第二构件的相互对应的第一和第二凹部的体积时,这是特别有益的。
在熔融结合部件时,第一和第二构件能够彼此直接机械接触,其中相互邻接能够通过对第一和/或第二构件施加相应的压缩力或者压力来支持。通过与熔融伴随地将第一和第二构件置于一起,能够补偿第一和/或第二表面的平面度的最终不平整度,由此提高密封的质量。
在另一优选的方面,流体导向组件设计为针头毂或者设计为药物递送装置的药筒毂,其中药物递送装置例如通过注射提供药剂给药。导向组件对于其中提供在不同药筒中的两个或更多药剂必需在递送到患者之前组合或者混合的药物递送装置是特别有用的。这样的导向组件在如下情况中具有进一步的应用,其中由不同容器或者药筒提供的不同药剂要以顺序方式通过药物递送装置的共同单个分配出口来分配。因此,该导向组件可以用作二合一接合构件或者用作T-形件导向构件。典型地,这种流体导向组件将布置在药物递送装置的包含药剂的药筒的下游,但位于可能与可替换的注射针头或者其它流体导向结构流体连接的分配端的上游。
根据另一独立方面,本发明还涉及适于经由出口分配预定量的至少一种药剂的药物递送装置。该药物递送装置可以设计为手持式注射器或者设计为笔式注射器,其包括用以接收被至少部分地填充有药剂的至少一个药筒的壳体。另外,该装置包括分配端,预定量的药剂经由该分配端被分配。此外,药物递送装置包括如上所述的流体导向组件,该流体导向组件布置在药筒或者药筒中的至少一个与分配端之间的流路中,以便由流体导向组件提供的至少一个通道结构能够提供相应的流体导向功能性。
在另一优选的方面,还提供了用以形成如上所述的流体导向组件的流体导向预组装件。该流体导向预组装件包括至少第一构件,其具有在第一表面部分中的至少一个凹部;并且还包括结合部件,其至少部分地填充所述凹部并且至少部分地从第一构件的第一表面部分突出。结合部件包括与第一构件的材料不同的材料,以选择性地接收热能以将第一构件与第二构件连结在一起。优选地并且如上所述地,第二构件以与结合部件的突出部分直接直接接触的构造被布置在第一构件的紧接附近。通过在最终的连结步骤中选择性地施加热能至结合部件,结合部件开始熔融并且由此将第一和第二构件连结在一起。
第一构件和/或要与之连结的第二构件另外包括沿着界面区域延伸的、由第一构件和/或第二构件的至少一个加深部形成的通道结构。通过借助于结合部件连结第一和第二构件,能够有效地密封通道结构。
在优选的方面,结合部件被预组装在第一构件的凹部中。例如,第一构件可以包括注射模制的塑料部件并且结合部件可以被注射模制在第一构件的凹部中,由此将结合部件与第一构件不可分离地互连。
总体上,关于流体导向组件描述和图示的全部特征和实施例同样地适用于流体导向预组装件。
在本文中所使用的术语“药物”或“药剂”意指含有至少一种药学活性化合物的药物配制剂,
其中在一个实施例中,药学活性化合物具有高至1500Da的分子量和/或是肽、蛋白质、多糖、疫苗、DNA、RNA、酶、抗体或其碎片、激素或者寡核苷酸、或者是上述药学活性化合物的混合物,
其中,在另一实施例中,所述药学活性化合物可用于治疗和/或预防糖尿病或与糖尿病相关的并发症比如糖尿病视网膜病变、血栓栓塞病症比如深静脉或肺血栓栓塞、急性冠状动脉综合征(ACS)、心绞痛、心肌梗死、癌症、黄斑变性、炎症、枯草热、动脉粥样硬化和/或类风湿性关节炎,
其中,在另一实施例中,所述药学活性化合物包括至少一种用于治疗和/或预防糖尿病或与糖尿病相关的并发症比如糖尿病视网膜病变的肽,
其中,在另一实施例中,所述药学活性化合物包括至少一种人胰岛素或人胰岛素类似物或衍生物,胰高血糖素样肽〔GLP-1〉或其类似物或衍生物,或exendin-3或exendin-4,或exendin-3或者exendin-4的类似物或衍生物。
胰岛素类似物例如是Gly(A21),Arg(B31),Arg(B32)人类胰岛素;Lys(B3),Glu(B29)人类胰岛素:Lys(B28),Pro(B29)人类胰岛素;Asp(B28)人类胰岛素;人类胰岛素,其中位置B28中的脯氨酸由Asp、Lys、Leu、Val或者Ala代替,并且其中在位置B29中,Lys可由Pro;Ala(B26)人类胰岛素;Des(B28-B30)人类胰岛素;Des(B27)人类胰岛素或者Des(B30)人类胰岛素代替。
胰岛素衍生物例如是B29-N-肉豆蔻酰-des(B30〉人胰岛素;B29-N-棕榈酰-des(B30)人胰岛素;B29-N-肉豆蔻酰人胰岛素;B29-N-棕榈酰人胰岛素;B28-n-肉豆蔻酰LysB28ProB29人胰岛素;B28-N-棕榈酰-LysB28ProB29人胰岛素;B30-N-肉豆蔻酰-ThrB29LysB30人胰岛素;B30-N-棕榈酰-ThrB29LysB30人胰岛素;B29-N-(N-棕榈酰-Y-谷氨酰)-des(B30)人胰岛素;B29-N-(N-石胆酰-Y-谷氨酰)-des(B30)人胰岛素;B29-N-(ω-羧基十七烷酰)-des(B30)人胰岛素和B29-N-(ω-羧基十七烷酰)人胰岛素。
Exendin-4例如是指Exendin-4(1-39),一种具有如下序列的肽:H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Al a-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2。
Exendin-4衍生物例如选择自如下的化合物列表:
H-(Lys)4-des Pro36,des Pro37Exendin-4(1-39)-NH2,
H-(Lys)5-des Pro36,des Pro37Exendin-4(1-39)-NH2,
des Pro36Exendin-4(1-39),
des Pro36[Asp28]Exendin-4(1-39),
des Pro36[IsoAsp28]Exendin-4(1-39),
des Pro36[Met(O)14,Asp28]Exendin-4(1-39),
des Pro36[Met(O)14,IsoAsp28]Exendin-4(1-39),
des Pro36[Trp(O2)25,Asp28]Exendin-4(1-39),
des Pro36[Trp(O2)25,IsoAsp28]Exendin-4(1-39),
des Pro36[Met(O)14Trp(O2)25,Asp28]Exendin-4(1-39),
des Pro36[Met(O)14Trp(O2)25,IsoAsp28]Exendin-4(1-39);或者
des Pro36[Asp28]Exendin-4(1-39),
des Pro36[IsoAsp28]Exendin-4(1-39),
des Pro36[Met(O)14,Asp28]Exendin-4(1-39),
des Pro36[Met(O)14,IsoAsp28]Exendin-4(1-39),
des Pro36[Trp(O2)25,Asp28]Exendin-4(1-39),
des Pro36[Trp(O2)25,IsoAsp28]Exendin-4(1-39),
des Pro36[Met(O)14Trp(O2)25,Asp28]Exendin-4(1-39),
des Pro36[Met(O)14Trp(O2)25,IsoAsp28]Exendin-4(1-39),
其中,所述基团-Lys6-NH2可以结合至Exendin-4衍生物的C-端;
或者具有如下序列的Exendin-4衍生物:
des Pro36Exendin-4(1-39)-Lys6-NH2(AVE0010),
H-(Lys)6-des Pro36[Asp28]Exendin-4(1-39)-Lys6-NH2,
des Asp28Pro36,Pro37,Pro38Exendin-4(1-39)-NH2,
H-(Lys)6-des Pro36,Pro38[Asp28]Exendin-4(1-39)-NH2,
H-Asn-(Glu)5des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-NH2,
des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36[Trp(O2)25,Asp28]Exendin-4(1-39)-Lys6-NH2,
H-des Asp28Pro36,Pro37,Pro38[Trp(O2)25]Exendin-4(1-39)-NH2,
H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-NH2,
des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36[Met(O)14,Asp28]Exendin-4(1-39)-Lys6-NH2,
des Met(O)14Asp28Pro36,Pro37,Pro38Exendin-4(1-39)-NH2,
H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2,
des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5desPro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-Lys6-des Pro36[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-Lys6-NH2,
H-des Asp28Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25]Exendin-4(1-39)-NH2,
H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-NH2,
des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(S1-39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2;
或前述exendin-4衍生物中任一种的药学上可接受的盐或溶剂合物。
激素例如是垂体激素或者丘脑激素或者调节活性肽和它们的拮抗剂,如2008版第50章Rote表中所列,比如是***(Gonadotropine)(促卵泡激素(Follitropin)、促黄体素(Lutropin)、绒毛膜***(Choriongonadotropin)、促配子成熟激素(Menotropin))、生长激素(somatropine)(促生长素(Somatropin))、去氨加压素(Desmopressin)、特利加压素(Terlipressin)、戈那瑞林(Gonadorelin)、曲普瑞林(Triptorelin)、亮丙瑞林(Leuprorelin)、布舍瑞林(Buserelin)、那法瑞林(Nafarelin)、戈舍瑞林(Goserelin)。
多糖例如是葡糖胺聚糖,比如透明质酸、肝素、低分子量肝素或超低分子量肝素或它们的衍生物、或者是上述多糖的硫酸化形式,例如是多聚硫酸化形式、和/或其药学上可接受的盐。多聚硫酸化低分子量肝素的药学可接受盐的实例是依诺肝素钠。
抗体是球状的血浆蛋白(~150kDa),也被称为共享基本结构的免疫球蛋白。因为它们具有添加至氨基酸残基的糖链,所以它们是糖蛋白。各个抗体的基本功能单元是免疫球蛋白(Ig)单体(只包含一个Ig单元);分泌的抗体也可以是具有两个Ig单元比如IgA的二聚物、具有四个Ig单元比如硬骨鱼IgM的四聚物或者具有五个Ig单元比如哺乳动物IgM的五聚物。
Ig单体是包括4个多肽链的“Y”形分子;两条相同的重链和两条相同的轻链由半胱氨酸残基之间的二硫键连接。每条重链为约440个氨基酸长;每条轻链为约220个氨基酸长。重链与轻链分别包含使它们折叠稳定的链内二硫键。每个链由所谓的Ig域的结构域构成。这些域包含约70-110个氨基酸,并且根据它们的大小和功能被分为不同的类别(例如,可变或V,和恒定或C)。它们具有特有的免疫球蛋白折叠,其中两个β片创建"三明治"形状,其通过保存的半胱氨酸与其他电荷的氨基酸之间的相互作用而保持在一起。
存在五种类型的哺乳动物Ig重链,以α、δ、ε、γ和μ标示。存在的重链类型定义了同种型的抗体;这些链分别地在IgA抗体、IgD抗体、IgE抗体、IgG抗体和IgM抗体中发现。
不同重链的大小与成分不同;α和γ包含约450个氨基酸,δ包含约500个氨基酸,而μ和ε具有约550个氨基酸。每个重链具有两个区,恒定区(CH)和可变区(VH)。在一个物种中,恒定区在同一同种型的所有抗体中基本上是相同的,但是在不同同种型的抗体中是不同的。重链γ、α和δ具有由三个串联的Ig域构成的恒定区和为了增加灵活性的铰链区;重链μ和ε具有由四个免疫球蛋白结构域构成的恒定区。重链的可变区在由不同B细胞产生的抗体中不同,但是对于由单一B细胞或B细胞克隆所产生的所有抗体来说是相同的。每个重链的可变区为约110个氨基酸长,并且是由单一Ig域构成的。
在哺乳动物中,有两种类型的免疫球蛋白轻链,由λ和κ表示。轻链有两个连续的域:一个恒定域(CL)和一个可变域(VL)。轻链的长度约为211至217个氨基酸。每个抗体包含两条总是相同的轻链;只有一种类型的轻链κ或λ存在于哺乳动物的每个抗体中。
虽然所有抗体的一般结构是非常相似的,但是给定抗体的独特属性由可变区(V)确定,如上所述。更具体地说,可变环,轻链(VL)上三个和重链(VH)上三个,负责抗原结合,即其抗原特异性。这些环被称为互补性决定区(CDR)。因为来自VH与VL域的CDR有助于抗原结合位点,所以不是任何单独的链而是重链与轻链的组合决定最终的抗原特异性。
"抗体片段"包含至少一个如上所定义的抗原结合片段,并且具有与片段所源自的完整抗体基本上相同的功能和特异性。具有木瓜蛋白酶的有限的蛋白水解消化将Ig原型分成三个片段。两个相同的氨基末端片段是抗原结合片段(Fab),每个包含一个完整的L链和约半个H链。第三片段是可结晶片段(Fc),其大小相似但是包含带有它们链间二硫键的两个重链的羧基末端的一半。Fc包含碳水化合物、补体结合和FcR结合位点。有限的胃蛋白酶消化产生单一的包含Fab片与铰链区的F(ab')2片段,包括H-H链间二硫键。F(ab')2是二价的抗原结合。F(ab')2的二硫键可被切割以获得Fab'。此外,重链与轻链的可变区可以熔合在一起,以形成单链可变区片段(scFv)。
药学可接受盐例如是酸加成盐和碱式盐。酸加成盐例如是HCl或者HBr盐。碱式盐例如是具有从碱或碱性物质选择的阳离子的盐,例如Na+、或K+、或Ca2+,或者是铵离子,例如N+(R1)(R2)(R3)(R4),其中R1至R4相互独立地指:氢,可选地替代的C1-C6-烷基基团、可选地替代的C2-C6-烯基基团、可选地替代的C6-C10-芳基基团、或可选地替代的C6-C10-杂芳基基团。药学可接受盐的另外的示例在1985年由Easton,Pa.,U.S.A的Mark PublishingCompany出版的由Alfonso R.Gennaro主编的第17版《Remington's PharmaceuticalSciences》及在《Encyclopedia of Pharmaceutical Technology(制药工艺学百科全书)》有说明。
药学可接受的溶剂合物例如是水合物。
对于本领域技术人员将进一步明显的是,对本发明能够进行各种修改和变化,而不偏离本发明精神和范围。另外,应注意,在所附权利要求中使用的任何附图标记并不旨在解释为限制本发明的范围。另外,本文所述的所有特征的实施例应理解为同样地适用于流体导向组件、药物递送装置以及流体导向组件的制造方法。具体地,关于部件被构造成或布置成执行具体操作的提及也应理解为对相应方法步骤的公开,并且反之亦然。
附图说明
在下文中,将参考附图说明用以实施本发明的多种可选且同样地可构思方式中的优选实施例。
图1示出了处于初始构造的流体导向组件的第一构件的横截面侧视图,
图2示出了第一构件,其中结合部件放置在凹部中,
图3图示了用以粘合地连结第一和第二构件的激光焊接过程,以及
图4示出了处于最后组装构造的流体导向组件,
图5进一步示出了激光焊接步骤,其中结合部件从第一构件的第一表面突出并且将第一和第二构件保持为间隔开的构造,
图6示出了执行组装方法的流程图,
图7图示了使用本发明的流体导向组件的药物递送装置,并且
图8示出了根据图7的药物递送装置的局部透明图。
具体实施方式
在图1至5的序列中,示出了流体导向组件10的制造或组装方法。起始地,提供了构造有面向上的第一表面部分22的第一构件12,该第一表面部分22由槽状加深部14以及由两个凹部16、18贯穿。加深部14以及凹部16、18在第一表面部分22的平面中延伸。
凹部16、18能够设计成彼此分开。但是,所示的凹部16、18也可以是在第一表面部分22的平面中围绕或者围起所述加深部14的单个凹部的部分。
所示的凹部或者加深部14、16、18中的任一个或者至少一个能够单独地引入或者制作到第一构件12的材料中。替代地,第一构件12能够易于通过例如注射模制步骤来提供或制成,以形成第一构件12。构件12优选地由热塑料材料制成,优选地由生物相容性或者符合PDA的塑料材料制成。
如图2所示,布置在加深部14的旁边的凹部16、18被至少部分地用结合部件26填充。结合部件26包括与第一构件12的材料不同的材料成分。多个结合部件26或者单个结合部件26成形为配合到凹部16、18中,如图2所示。结合部件26能够压配合在凹部中,或者一体地形成并且布置在凹部中。还可构思到,结合部件26和第一构件12被注射模制,例如经由双部件或多部件的注射模制过程进行。另外,结合部件26可以与第一构件12及其例如燕尾状的凹部16、18积极(positively)接合,例如当构造有底切和/或相应突起时。
具体地,图2示出了流体导向预组装件,其中结合部件26布置在第一构件12的凹部16、18中并且从凹部突出。
此后,示出为基本上平坦状板状构件的第二构件20被布置在第一构件12的顶部上。第二构件20构造有下部或面向下的第二表面部分24,该第二表面部分24面向第一构件12的上部第一表面部分22。
如图3所示,结合部件26至少从第一表面部分22略伸出。因此,在所示的预组装构造中,第二构件20布置在第一构件12的顶部上并且通过与结合部件26的从相应凹部16、18突出的面向上的表面部分的唯一机械接触被支撑。这样,在第一构件12和第二构件20之间形成小的间隙28。当流体导向组件如图3中所示地被预组装时,结合部件26开始经受有选择的热能施加,例如通过将高强度的和/或高度聚集的激光辐射32照射到结合部件26的区域中来施加。
由于第二构件20的和/或第一构件12的材料对于所选激光辐射32具有相对较小程度的吸收作用,所以辐射能的主要部分能够有效地且专门地提供在结合部件26中或者上。因此,制成结合部件26的材料的光学吸收特性针对所选光谱范围的电磁辐射32设计和/或适合于该光谱范围。
在第一构件12的上部第一表面部分22中设置的U形槽或者加深部14被第二构件20的面向下的第二表面部分24覆盖和围起。在熔融结合部件26的过程中,压缩力34也可以施加到第二构件20的顶部上,以使第一和第二构件12、20的表面部分22、24处于直接相互且密封的邻接构造,如图4所示。从而,能够在第一和第二构件12、20之间的界面区域15中形成闭合且液密的通道结构13。
如图4中另外示出的,能够在加深部14和相邻地定位的第二表面部分24之间提供液密密封。这样,能够实现第一和第二构件12、20的热引发的连结或者一体结合,而不用对可能对热敏感的所述部件提供热能。
图5示出了另一实施例,其中与图1至4的序列中所示的实施例不同,第二部件20包括位于面向下的第二表面部分24中的凹部36、38。凹部36、38的大小和位置对应于设置在第一构件12的第一表面部分22中的凹部16、18的大小和位置。如图5中进一步示出的,结合部件26沿与第一和/或第二表面部分22、24的表面法线平行的方向延伸。结合部件26的竖向延伸基本上大于凹部16和36的和/或凹部18、38的相应深度之和。
如图5中进一步示出的,第二部件的凹部36、38可以比第一部件的凹部16、18宽,或者比结合部件26的横向延伸略宽。完全地填充第一部件12的凹部16、18的结合部件26可以延伸到第二部件20的面向下的凹部36、38,从而形成横向间隙。在熔融结合部件26时,结合部件26的过量材料可以延伸到并且填充这些横向间隙。
在预组装构造下,如图5所示,还能够在第一和第二表面部分22、24之间实现竖向间隙30,该间隙30在结合部件26开始承受热能施加以及开始熔融时最小化为零。
另外,如图3和5中所示,通过例如电磁辐射32引起的热能施加能够伴随以施加压缩力34,通过该压缩力34,能够将第一和第二构件12、20牢固地按压在一起。当在施加热能之前第一和第二部件12、20被保持非彼此邻接的距离28、30时,结合部件26的熔化过程可以伴随以至少第一和第二构件12、20的略微相对位移,并且平行于第一和第二表面部分22、24的平面,由此补偿第一和/或第二构件12、20的最终平面度容差。根据图5的实施例就焦点或者焦平面而言也是有益的,其中进入结合部件26的幅射32能够略提高,例如,至少因为间隙30的大小。因此,热能提供或者施加到结合部件26中的部位能够进一步远离通道结构13,由此减小在通道结构13的直接或紧密邻近处的热应力。这会带来改善的密封并且带来激光焊接过程的更好可重复性以及再现性。
另外,有必要指出,通道结构13能够以多种不同方式形成在界面区域15中。第一构件12和/或第二构件20的相互对应的或者配套的凹部结构或者槽可以具有长方形、椭圆形、圆形形状。另外,通过分别设置在第一构件12和第二构件20中的两个相互对应的V形槽,可以形成相当方形或者矩形的通道结构。
在图6中,如图1至5的序列中所示的制造或者组装流体导向组件10的各步骤的流程图被示意性地示出。因此,在第一步骤100中,供给或者提供或者制成第一构件12,例如通过注射模制完成。之后,在步骤102中,在第一构件12的第一表面部分22中延伸的至少一个凹部16、18被用结合部件26至少部分地填充。
随后,在步骤104中,第二部件20被置于第一部件12的顶部,其中第二构件20优选地与非熔融的结合部件26直接接触。之后,在步骤106中并且如图3所示,热能被提供到结合部件26中,导致所述部件熔融并且导致在结合部件26和与之直接机械接触的相邻地布置的第一和第二构件12、20之间形成连结。
施加热能优选地伴随以施加压缩力34或者与之关联,压缩力34优选地均匀分布在第一和第二构件12、20的表面部分22、24上。这样,能够在可能由相同塑料材料制成的第一和第二构件12、20之间构成精准的且范围明确的粘合连结或者整体结合。
图7和8最后示出了手持式药物递送装置50,其具有壳体54和活动盖子52。装置50包括邻近远端部68的分配端56,该分配端56被设计为带螺纹的容座,例如用以螺旋地接收具有例如双端注射针头的针头毂,以通过注射来分配药剂。如图8所示,壳体54容纳有至少部分地填充有药剂的两个药筒60。另外,装置50包括接口58,以提供在分配端56与所述药筒60中任一个之间的流体连通。接口58可以配备有如图1至5所示的流体导向组件10,以提供被提供在两个药筒60中的药剂的混合,或者经由单个分配端56提供不同药剂的顺序分配。
如图8中进一步示出的,该装置包括邻近其近端66的显示元件62以及用以控制和/或操纵药剂分配动作的各种按钮或者键元件64。
附图标记列表
10流体导向组件
12第一构件
13通道结构
14加深部
15界面区域
16凹部
18凹部
20第二构件
22表面部分
24表面部分
26结合部件
28间隙
30间隙
32电磁辐射
34压缩力
36凹部
38凹部
50药物递送装置
52盖子
54壳体
56分配端
58接口
60药筒
62显示元件
64按钮
66近端
68远端
Claims (21)
1.一种制造流体导向组件的方法,包括如下步骤:
-提供第一构件(12),所述第一构件(12)具有位于第一表面部分(22)中的至少一个凹部(16,18),
-用结合部件(26)至少部分地填充所述凹部(16,18),所述结合部件(26)至少部分地从所述第一构件(12)的所述第一表面部分(22)突出,
-将具有第二表面部分(24)的第二构件(20)布置为邻近所述第一构件(12),以便其第一和第二表面部分(22,24)向着彼此以形成所述第一和第二构件(12,20)之间的界面区域(15),
-其中所述结合部件包括与所述第一和/或第二构件(12,20)的材料不同的材料,
-其中沿着所述界面区域(15)延伸的至少一个通道结构(13)由所述第一构件(12)的和/或所述第二构件(20)的至少一个加深部(14)形成,
-选择性地提供热能到所述结合部件(26),以将所述第一和第二构件(12,20)连结在一起,
-其中,所述第二构件(20)包括在所述第二表面部分(24)中的凹部(36,38),所述凹部(36,38)的大小和位置对应于所述第一构件(12)的第一表面部分(22)中的至少一个凹部(16,18),
-其中,所述热能通过在预定光谱范围将激光辐射(32)聚焦到所述结合部件(26)的区域中来提供给所述结合部件(26),针对该预定光谱范围,所述结合部件(26)与所述第一和第二构件(12,20)之一的材料相比具有更大的吸收系数。
2.根据权利要求1所述的方法,其中,所述结合部件(26)适于响应于吸收电磁辐射而熔融。
3.根据权利要求1所述的方法,其中,在施加热能到所述结合部件(26)期间,所述第一和第二构件(12,20)被按压在一起。
4.根据权利要求1所述的方法,其中,所述第一和第二构件(12,20)在承受压缩力时建立彼此邻接构造。
5.根据权利要求1所述的方法,其中,当以相互邻接构造布置所述第一和第二构件(12,20)时,设置在第一构件(12)的凹部(16,18)中的结合部件(26)延伸到第二构件(20)的凹部(36,38)中。
6.根据权利要求1所述的方法,其中,所述结合部件(26)的沿与所述第一和/或第二表面部分(22,24)的表面法线平行的方向的延伸部大致大于第一和第二构件(12,20)的相互对应的凹部(16,36,18,38)的相应深度之和。
7.根据前述权利要求1或6中任一项所述的方法,其中,所述第二构件(20)的凹部(36,38)比所述第一构件(12)的凹部(16,18)宽。
8.根据权利要求1所述的方法,其中,所述第二构件(20)的凹部(36,38)比所述结合部件(26)的横向延伸部宽。
9.根据权利要求8所述的方法,其中,在熔融所述结合部件(26)时,所述结合部件(26)的过量材料延伸到位于所述结合部件和所述第二构件(20)的凹部(36,38)之间的横向间隙中并且填充该间隙。
10.根据权利要求9所述的方法,其中,在重力或者压力作用下,正在熔融或者熔融后的结合部件(26)均匀地分布在第一构件(12)的至少一个凹部(16,18)中或者分别地分布在第一和第二构件(12,20)的相互对应且基本上重叠的凹部(16,18,36,38)中。
11.根据权利要求9或10所述的方法,其中,第一和第二构件(12,20)之间的竖向间隙大小用以控制结合部件(26)中的能量吸收。
12.根据前述权利要求1到3中任一项所述的方法,其中,提供热能到所述结合部件(26),直到第一和第二构件(12,20)的第一和第二表面部分(22,24)直接机械接触地彼此邻接。
13.一种用于药物递送装置的流体导向组件,其根据前述权利要求中任一项所述的方法组装,并且包括:
-第一构件(12),所述第一构件(12)具有位于第一表面部分(22)中的至少一个凹部(16,18),
-与所述第一构件(12)相邻地布置的第二构件(20),所述第二构件(20)具有第二表面部分(24),所述第二表面部分(24)面向所述第一构件(12)的第一表面部分(22)以形成所述第一和第二构件(12,20)之间的界面区域(15),
-至少一个通道结构(13),所述至少一个通道结构沿着所述第一和第二构件(12,20)的所述界面区域(15)延伸并且由在所述第一构件(12)中和/或在所述第二构件(20)中的至少一个加深部(14)形成,
-其中所述至少一个凹部(16,18)被至少部分地用结合部件(26)填充,所述结合部件(26)包括与所述第一和/或第二构件(12,20)的材料不同的材料,
-其中,所述第二构件(20)包括在所述第二表面部分(24)中的凹部(36,38),所述凹部(36,38)的大小和位置对应于所述第一构件(12)的第一表面部分(22)中的至少一个凹部(16,18),
-其中,所述结合部件(26)与所述第一和/或第二构件(12,20)的材料相比具有对于预定光谱范围的激光辐射(32)的更大吸收系数。
14.根据权利要求13所述的流体导向组件,其中,第一和第二构件(12,20)的第一和第二表面部分彼此补充,以提供沿着界面区域(15)延伸的通道结构。
15.根据权利要求13所述的流体导向组件,其中,第二构件(20)包括在第二表面部分(24)中的凹部(36,38),该凹部的大小和位置对应于第一构件(12)的第一表面部分(22)中的至少一个凹部(16,18)。
16.根据权利要求13所述的流体导向组件,其中,所述第二构件(20)至少横过所述第一构件(12)的所述加深部(14)延伸以形成闭合的流体导向通道结构(14)。
17.根据权利要求16所述的流体导向组件,其中,第一和第二构件(12,20)中的至少一个包括注射模制的生物相容或者化学惰性的塑料材料。
18.根据权利要求13所述的流体导向组件,其中,所述至少一个凹部(16,18,36,38)和结合部件(26)与通道结构(13)空间分开,用以接收结合部件(26)的至少一个凹部(16,18,36,38)布置在用以形成通道结构(13)的所述加深部(14)的空间范围之外。
19.一种适于经由出口分配预定量的药剂的药物递送装置,包括:
-壳体(54),所述壳体(54)用以接收至少部分地填充有药剂的至少一个药筒(60),
-分配端(56),所述分配端(56)用于分配预定量的所述药剂,和
-根据权利要求13所述的流体导向组件,所述流体导向组件布置在所述药筒(60)和所述分配端(56)之间,其中所述流体导向组件的所述至少一个通道结构(13)布置在位于所述至少一个药筒(60)和所述分配端(56)之间的流路中。
20.一种流体导向预组装件,用于形成根据权利要求13所述的流体导向组件,包括:
-至少第一构件(12),所述第一构件(12)具有位于第一表面部分(22)中的至少一个凹部(16,18),和
-结合部件(26),所述结合部件(26)至少部分地填充所述凹部(16,18)并且从所述第一构件(12)的第一表面部分(22)至少部分地突出,其中所述结合部件(26)包括与所述第一构件(12)的材料不同的材料,以选择性地接收热能用于将所述第一构件(12)与第二构件(20)连结在一起,并且,所述结合部件(26)与所述第一和第二构件(12,20)之一的材料相比具有对于预定光谱范围的激光辐射(32)的更大吸收系数。
21.根据权利要求20所述的流体导向预组装件,其中,结合部件(26)与第二构件(20)的对应地形成的凹部(36,38)摩擦接合或者积极接合。
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PCT/EP2012/072788 WO2013072439A1 (en) | 2011-11-16 | 2012-11-15 | Medicament guiding assembly for a drug delivery device |
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DE102016212690A1 (de) * | 2016-07-12 | 2018-01-18 | Robert Bosch Gmbh | Verfahren zum Ausbilden einer Laserschweißverbindung und Bauteileverbund |
CN112292168B (zh) * | 2018-06-22 | 2023-11-28 | 赛诺菲 | 药物输送装置、用于制造药物输送装置的方法和焊接连接的用途 |
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EP1002843A2 (de) * | 1998-11-21 | 2000-05-24 | DaimlerChrysler AG | Verfahren zum lösbaren Verbinden von Bauteilen |
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