CN112839700B - 数字微流控输送装置 - Google Patents

数字微流控输送装置 Download PDF

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CN112839700B
CN112839700B CN201980067527.7A CN201980067527A CN112839700B CN 112839700 B CN112839700 B CN 112839700B CN 201980067527 A CN201980067527 A CN 201980067527A CN 112839700 B CN112839700 B CN 112839700B
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R·J·小保利尼
S·J·特尔弗
T·J·奥马利
B·D·比恩
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Abstract

一种活性分子输送系统，其中活性分子可以按需释放和/或多种不同的活性分子可以从相同的系统输送和/或不同浓度的活性分子可以从相同的系统输送。本发明非常适合于将药物经皮地输送给患者。在一些实施例中，该系统包括两个单独的储存器和混合区域，从而允许在经皮输送之前直接混合前体。

Description

数字微流控输送装置
相关申请
本申请要求于2018年10月15日提交的共同未决的美国临时专利申请No.62/745,718的优先权。本文所公开的所有专利、公开申请和未决申请均通过引用整体并入本文。
背景技术
数字微流控装置使用独立的电极在受限的环境中推进、分裂和结合微滴，从而提供“片上实验室”。数字微流控装置可替代地称为介质上电润湿，或“EWoD”，以进一步区分该方法与依赖电泳流和/或微泵的竞品微流控系统。Wheeler在“Digital Microfluidics,”Annu.Rev.Anal.Chem.2012,5:413-40中提供了电润湿技术的2012年的综述，其全部内容通过引用包含于此。该技术允许使用少量的样品和试剂执行样品制备、试验和合成化学。近年来，使用电润湿在微流控单元中进行受控的微滴操纵已经变得商业上可行；并且现在可从大型生命科学公司(如牛津纳米孔公司(Oxford Nanopore))获得产品。
关于EWoD的大多数文献报道都涉及所谓的“被动矩阵”装置(又称“分段”装置)，其中用控制器直接驱动十到二十个电极。虽然分段装置易于制造，但是电极的数量受到空间和驱动约束的限制。因此，不可能在被动矩阵装置中执行大规模的平行试验、反应等。相比之下，“主动矩阵”装置(又称主动矩阵EWoD，又称AM-EWoD)装置可以具有成千上万、数十万或者甚至数百万个可寻址电极。电极通常通过薄膜晶体管(TFT)进行切换，并且微滴运动是可编程的，使得AM-EWoD阵列可以用作通用装置，从而为控制多个微滴和执行同步分析过程提供了极大的自由度。
由于对电场泄漏的严格要求，大多数先进的AM-EWoD装置是由多晶质的硅(又称多晶硅，又称多晶Si)构成的。然而，多晶硅制造实质上要比非晶硅制造(即LCD显示工业的大量生产的主动矩阵TFT中使用的类型)更昂贵。多晶硅制造工艺更昂贵，因为存在用于多晶硅的独特的处理和制造步骤。全球范围内配置为由多晶硅制造器件的设施也较少。然而，由于多晶硅功能的改进，夏普公司(Sharp Corporation)已经能够在单个主动矩阵上实现包括推进、传感和加热能力的AM-EWoD装置。参见，例如，美国专利No.8,419,273、8,547,111、8,654,571、8,828,336、9,458,543，所有专利的全部内容通过引用包含于此。图1示出了复杂的多晶硅AM-EWoD的示例。
生物活性材料的经皮输送是成熟的技术。在最直接的实施例中，将生物活性成分(通常是分子量低于1000的分子)掺入与患者的皮肤接触的聚合物基质或凝胶中。分子的渗透通常在几个小时的时间内通过被动扩散发生。通过将贴片施用到皮肤上而启动药物输送。然而，在当前的现有技术中，难以调节从一个特定贴片输送活性成分的速率。
发明内容
本发明通过提供低功率经皮输送系统来解决该需求，由此活性分子可以装载于数字微流控平台并按需释放。另外，如下所述，本发明提供一种用于在不同时间从同一输送系统输送不同浓度的活性分子、以及用于从同一贴片在相同或不同时间输送多种药物的系统。
本发明通过将活性物质(即药物)保存在储存器中直至其被需要，并且然后将该活性物质移至与皮肤接触的多孔扩散层(例如药物输送凝胶)而起作用。在一个方面，本发明是一种活性分子输送系统，包括第一基板、第二基板、间隔物、多孔扩散层和控制器。第一基板包括多个驱动电极、覆盖多个电极的介电层和覆盖介电层的第一疏水层。第二基板包括公共电极和覆盖公共电极的第二疏水层。间隔物将第一基板和第二基板分开，并在第一基板和第二基板之间创建微流控区域。多孔扩散层耦合到第一基板的与第一疏水层相对的基板的一侧上，并且第一基板包括在疏水层和多孔扩散层之间提供流体连通的通道。控制器可操作地耦合到驱动电极并且被配置为在至少两个驱动电极之间提供电压梯度。多孔扩散层可以由多种材料构成，例如丙烯酸酯、甲基丙烯酸酯、聚碳酸酯、聚乙烯醇、纤维素、聚(N-异丙基丙烯酰胺)(PNIPAAm)、聚(乳酸-羟基乙酸共聚物)(PLGA)、聚偏二氯乙烯、丙烯腈、无定形尼龙、取向聚酯、对苯二酸酯、聚氯乙烯、聚乙烯、聚丁烯、聚丙烯、聚异丁烯或聚苯乙烯。通常，储存器的体积大于100nL，并且多孔扩散层的平均孔径在1nm至100nm之间。在一些实施例中，装置包括多个通道。在一些实施例中，通道包括芯吸材料，例如毛细管或纤维。在一些实施例中，多孔扩散层通过生物相容性粘合剂耦合至受试者。
通常，活性分子是药类化合物；然而，本发明的系统可用于输送激素、营养制剂、蛋白质、核酸、抗体或疫苗。本发明可以包括多个储存器，并且该装置可以被配置为在施用组分之前混合组分。例如，可能在同一装置内具有不同的储存器，其包含不同的混合物或具有不同浓度的类似混合物。例如，系统可以包括包含第一活性分子的混合物的第一储存器和包含第二活性分子的混合物的第二储存器，或者系统可以包括包含第一浓度的活性分子的第一储存器和包含第二浓度的相同活性分子的第二储存器。在其他实施例中，该系统可以包括包含活性分子的混合物的第一储存器和包含辅助剂和/或皮肤渗透剂的第二储存器。活性分子、药剂和浓度的其他组合对于本领域技术人员将是显而易见的。
本发明另外包括用于控制活性分子输送系统的控制器。该控制器包括如上所述的活性分子输送系统，即，包括分散在第一带电相中的活性分子和第二相的混合物，所述第二相带相反电荷或者不带电并且与第一相不混溶，或者包括活性分子和带电粒子的混合物。控制器还可以包括开关，该开关被配置为中断从电压源到活性分子输送系统的流动。开关可以是机械开关或数字开关，并且控制器可以包括用于控制开关的处理器。在一些实施例中，控制器将包括无线接收机和无线发射机，从而允许控制器与诸如智能电话、扩展坞、智能手表、健身追踪器等的装置接口。
本发明的装置可用于将活性分子输送至受试者的皮肤。例如，使用本发明的装置，可以将多孔扩散层耦合至受试者的皮肤，可以将包含活性分子的溶液从驱动电极移动至在疏水层与多孔扩散层之间提供流体连通的第一通道，以及可以允许活性分子从多孔扩散层通过并到达受试者的皮肤。在一些实施例中，将活性物质保存在与多个驱动电极流体连通的第一储存器中，并且将包含活性分子的溶液保存在储存器中，直到需要输送包含活性分子的溶液为止。在一些实施例中，装置具有两个分离的储存器和混合区域，并且活性分子被输送至患者。第一储存器包括第一前体溶液，第二储存器包括第二前体溶液，并且输送功能包括将第一前体分子与第二前体分子混合以产生混合物并将该混合物移动至在疏水层和多孔扩散层之间提供流体连通的通道。
附图说明
图1示出了在相同的主动矩阵上包括推进和感测的现有技术的EWoD装置。
图2描绘了通过在相邻电极上提供不同的带电状态，水相微滴在相邻电极之间的移动。
图3描绘了当装置处于“关闭状态”时，即，尚未装载活性物质时的本发明的横截面。
图4描绘了当装置处于“接通状态”时，即，已经装载了活性物质时的本发明的横截面。
图5是本发明的装置的平面图，包括活性材料的储存器、驱动电极、通道和多孔扩散层。图5分步地(从底部至顶部)示出了分配包括活性分子的溶液、将微滴移向通道、移动到通道、以及将微滴分配到多孔扩散层中。
图6示出了本发明的装置，其中每个通道仅耦合至单个储存器。在一些实施例中，每个储存器包含不同浓度的活性分子，从而允许动态控制剂量。
图7示出了本发明的装置，其中两个不同的储存器耦合至混合区域，由此可以在输送至多孔扩散层之前混合两种组分“A”和“B”。
图8示出了本发明的输送装置，其中驱动电极是柔性的，从而允许将输送装置围绕肢体(例如手臂或腿)缠绕。
具体实施方式
本发明提供一种活性分子输送系统，借此活性分子可以按需释放和/或多种不同的活性分子可以从相同的系统输送和/或不同浓度的活性分子可以从相同的系统输送。本发明非常适合于将药物经皮地输送给患者，然而，本发明通常可以用于将活性成分输送给动物。活性输送系统包括多个储存器，其中储存器填充有用于输送活性分子的介质。在一些实施例中，介质包括分散在第一带电相中的活性分子以及第二相，所述第二相带相反电荷或者不带电并且与第一相不混溶。
用于经皮输送的一个令人关注的分子是纳洛酮，纳洛酮是一种有竞争力的阿片受体拮抗剂，其用于防止或降低阿片类麻醉剂过量的影响。当口服时纳洛酮不易吸收，并且通常通过注射或通过鼻喷雾剂施用。不幸的是，药物的作用在不到约一个小时后减弱，需要多剂量给药以长期维持治疗剂水平。但是，先前的工作表明，使用面积约40cm2的经皮贴片可能能够在约4-48小时的时间段内维持有用的纳洛酮血浆浓度。参见，例如，Panchagula，R.，Bokalial，R.，Sharma，P.和Khandavilli，S.，International Journal of Pharmaceutics，293(2005)，213-223。因此，初始注射剂量与较长效经皮输注的组合可以提供一种实用的手段来维持纳洛酮的治疗浓度，同时避免使患者经受多次注射。
军事和民事现场急救员，包括执法人员，在可能无法获得常规医疗服务的危险情况下，面临暴露于高浓度的阿片类麻醉剂的可能性。理想地，他们将能够自我施用纳洛酮(或类似药物)的初始药量，并且同时能够触发维持剂量的较长期释放。在某些情况下，甚至可能需要远程触发药物释放，尤其是在受影响的个人独立运动能力受到损害的情况下。在这些情况下，将优选地使用预敷经皮贴片，所述预敷经皮贴片处于在某种意义上无法获得待输送药物的状态。触发事件将释放药物，允许其开始通过皮肤扩散。当然，输送装置不限于这些示例，并且可以用于输送例如激素、营养制剂、蛋白质、核酸、抗体或疫苗。
本发明的装置通过使用介质上电润湿(EWoD)移动活性物质的水性微滴来起作用。EWoD装置的基本操作在图2的截面图中示出。EWoD 200包括填充有油202和至少一个水性微滴204的单元。单元间隙通常在50到200μm的范围内，但是间隙可以更大。如图2所示，在基本配置中，多个驱动电极205设置在一个基板上，并且单个的顶部电极206设置在相对的表面上。该单元另外还包括在与油层接触的表面上的疏水涂层207，以及在驱动电极205和疏水涂层207之间的介电层208。(上基板也可以包括介电层，但是图2中未示出)。疏水层防止微滴润湿表面。当在相邻电极之间未施加电压差时，微滴将保持球形以最小化与疏水表面(油和疏水层)的接触。因为微滴不会润湿表面，所以它们不太可能污染表面或与其他微滴相互作用，除非期望这种行为。
虽然可以具有用于介电和疏水功能两者的单个的层，但是这样的层通常需要厚的无机层(以防止针孔)，从而导致低的介电常数，因此将需要大于100V来使得微滴运动。为了实现低电压致动，最好具有薄的无机层以获得高电容且没有针孔，在其上加有薄的有机疏水层。通过这种组合，可以在+/-10至+/-50V范围内的电压下进行电润湿操作，该范围处于常规TFT控制器可以提供的范围内。
当在相邻电极之间施加电压差时，一个电极上的电压在介电-微滴界面处吸引微滴中的相反的电荷，并且微滴朝该电极移动，如图2所示。可接受的微滴推进所需的电压取决于介电层和疏水层的性质。交流(AC)驱动用于减少各种电化学对微滴、电介质和电极的降解。EWoD的工作频率可以在100Hz到1MHz的范围内，但是用于操作速度有限的TFT时，最好是1kHz或更低的较低频率。
图3以横截面形式(未按比例)示出了当设置在皮肤380上时，本发明的活性分子输送装置300的操作原理。装置300被构造在一个或多个基板310/315上，基板310/315可以是柔性基板。公共电极340通过间隔物330与驱动电极345间隔开。将要输送的活性分子(药物)被溶解在悬浮于不相容溶剂325(例如，碳氢化合物、硅树脂或氟化有机油)中的水滴320中。如上所讨论的，向公共电极340和驱动电极345施加适当的电压可用于使水滴320横向地朝向耦合至多孔扩散层370的通道360移动(从左至右)。为了促进水滴320的移动，在公共电极340下方和驱动电极345上方提供疏水层335。介电层350在疏水层335与驱动电极345之间。
本发明的装置包括一个或多个通道360(即，z方向上的通道)，该通道穿过或邻近驱动电极345。如图4所示，当水滴320位于这样的通道360上方时，活性分子可以移动通过通道360到达与输送表面(例如患者的皮肤380)接触的多孔扩散层370。在该位置处，在水滴320和与皮肤380接触的多孔扩散层370之间建立了扩散接触。通常，通道360将包括促进溶剂和活性混合物从疏水表面335向多孔扩散层370移动的结构。例如，通道可以包括通过毛细作用移动亲水材料的材料，例如芯吸纤维、纤维素或棉。这样的材料可以涂布有附加的疏水涂层，以促进水性溶液从电润湿表面向多孔扩散层370的移动。在一些实施例中，可以将生物相容性粘合剂(未示出)层压到多孔扩散层。生物相容性粘合剂将允许活性分子通过，同时保持装置固定在用户上。合适的生物相容性粘合剂可购自3M(明尼苏达州，明尼阿波利斯(Minneapolis,MN))。
图5示出了本发明的活性分子输送装置500的实施例的顶视图，如同顶部电极和顶部基板已被移除。装置500包括基板515、驱动电极545、通道560和多孔扩散层570。该装置另外还包括控制器543，其通过迹线547耦合到驱动电极545。如图5所示，包含要输送的靶分子(药物)的亲水性液体位于储存器590中，即装置的远离与皮肤接触的多孔扩散层的区域。
图5中示出了从底部驱动电极到顶部驱动电极的包括活性分子的溶液的输送顺序。最初，微滴520从储存器590脱开，从而确定将要输送的剂量(浓度x体积x微滴数量)。微滴520前进，直到它们与一个或多个通道560相邻，随后，围绕通道560的辅助驱动电极548用于使用正交电湿润将微滴520移动到通道560上方。由于通道560的芯吸作用，微滴520将移动进入并通过通道560，随后将其输送到下面的多孔扩散层570。因此，储存器590中的活性成分可以移动到多孔扩散层中。
可以想象驱动电极545相对于通道560的许多不同的布置。在图6中示出的第二实施例中，电润湿力用于将流体620从储存器690抽出并将其直接转移至通道660。装置600包括基板615、驱动电极645、通道660和多孔扩散层670。该装置另外还包括控制器643，其通过迹线647耦合到驱动电极645。然而，在图6中不需要正交运动。由驱动电极645和多孔扩散层670之间的合适材料提供的毛细力将流体620从储存器690抽出。虽然流体620被示出为连续的，但是应当理解，流体可以以如图5中的微滴输送。如图6所示，每个通道660耦合至特定的储存器690。这允许每个储存器充当单次剂量，从而降低了系统的复杂性，例如，其中必须脱开并输送特定剂量的特定体积的特定数量的微滴。例如，装置600可以包括七个相同的储存器，并且控制器643被配置为在连续七天的每个早晨施用一个储存器的内容物。可替代地，不同的储存器690可各自包含不同浓度的相同活性物质，以使得例如受试者可以接受第一较强剂量的活性物质，然后在当日接受一个或多个较低浓度的维持剂量。这样的装置可能特别适合于输送激素。
图7中示出了本发明的另一实施例，其中装置700包括基板715、驱动电极745、通道760和多孔扩散层770。虽然未示出控制器，但是应当理解，需要控制器来协调驱动电极745的功能。图7示出在输送活性分子之前“在片上”进行反应是可能的。如图7所示，第一储存器“A”791和第二储存器“B”792都与混合区域793流体连通。第一前体分子可以包含在第一储存器791中的第一溶液中，而第二前体分子可以包含在第二储存器792中的第二溶液中。在施用活性物质之前，将第一溶液和第二溶液带到混合区域793，在此处它们被允许混合以产生靶活性物质，然后将该靶活性物质以上述方法输送到多孔扩散层770。
装置700具有许多优点，该装置具有在将靶活性物质输送到多孔扩散层770之前混合前体的能力。例如，第一前体可以是敏感的生物制剂，例如抗体或寡核苷酸，其必须稳定在不适合通过多孔扩散层输送的溶液中以储存。因此，当适当地输送生物制剂时，一定量从第一储存器791转移到混合区域793，在此处生物制剂可以被激活、清洁或靶向输送(例如，通过与催化剂、标记物或其他靶向特定分子的结合)。这样的配置可以极大地增加生物制剂的保质期，并且它们可以允许患者避免必须去诊所以通过静脉注射输送生物制剂。在其他替代方案中，第一和第二前体可以是结合以产生阿片类药物的药物前体。使用本发明的装置，可以防止非法的阿片类药物的施用，因为只有具有该装置并具有适当的安全授权的用户才可以将前体组合以生成阿片类药物。
图7的系统还可以适于输送所谓的“药物混合物”，该药物混合物包括随时间而彼此失活的活性分子，并且通常必须在诊所(例如化疗门诊)中施用。图7的系统还可以用于输送例如患者自身的细胞、抗体等。在这样的实施例中，可以将患者自身的生物材料保存在第一储存器中，并且当适于输送治疗剂时，患者自身的生物材料被移动到混合区域，在此处，它们与另一种活性成分混合，然后再输送至多孔扩散层。
控制器543、643、743可以包括启动电润湿运动所需的电池和电子设备，以及例如合适的电子设备/天线等与外界通信的装置。在优选的布置中，在不施加电信号的情况下将不可能将包含药物的水滴转移至通道。这将确保未激活的贴片可以承受各种应力(机械应力、热应力等)而不会释放活性成分。
在一个实施例中，本发明的装置可用于输送纳洛酮(NARCANTM)。该装置将约20-100mg的药物从储存器输送至多孔扩散区域。假设储存器中水中活性物质(例如纳洛酮)的浓度接近饱和，为50mg/mL，则需要输送的微滴体积约为400-2000μL，这在装置的能力范围内。在其他实施例中，本发明的装置可用于输送阿片类药物，例如氢化吗啡酮、氢可酮、芬太尼、美沙酮或氧可酮。本发明的装置可用于输送兴奋剂，例如尼古丁、类固醇(例如强的松)和激素(例如肾上腺素)。
在一些实施例中，本发明的装置可以被制成柔性的，使得该装置可以被部署在弯曲表面880上和/或被集成到柔性包装中以提高用户舒适度和依从性。这样的装置800的实施例在图8中示出，由此，柔性驱动电极845耦合到多孔扩散层870，并且通道860在驱动电极845和多孔扩散层870之间提供流体连通。如图8所示，控制器843和储存器890可以组合到同一壳体中。在一个实施例中，装置800可以采用腕带的形状，由此装置800可以额外地增加装饰性设计，以掩盖装置800实际上用于经皮地输送药物。
活性分子输送系统的先进实施例将包括允许用诸如智能电话或智能手表之类的辅助装置无线地控制活性分子输送系统的电路。通过这样的改进，用户可以例如控制所输送的活性分子的类型和所输送的量。使用例如智能电话或手表上的应用程序，可以对装置进行编程以基于一天中的时间修改所输送的活性分子的量。在其他实施例中，该装置可以与生物计量传感器(例如，健身追踪器或心率监测器)可操作地耦合，由此，例如，如果用户的脉搏率超过预设阈值，则该应用使剂量将被关闭。其他实施例可以例如将来自血糖监测器的读数耦合到该装置，以当患者超出其期望的血糖水平时允许胰岛素的自动输送。
当需要时，本发明的装置可以被远程激活和/或控制。例如，可以使用NFC、蓝牙、WIFI或其他无线通信功能来激活装置并使得药剂被施用。此外，相同的无线通信可用于监视装置的性能，例如，了解处于不同驱动状态的所有储存器的百分比和区域，这意味着提供者或治疗师可以获得所有使用数据，包括贴片何时被激活以及施用了多少量的活性物质。对于“可编程”特征，由于每个储存器都可以独立地变化，因此可以通过在不同时间从不同存储存器驱动不同浓度的活性物质或不同的活性物质来对装置的总释放曲线进行编程。此外，患者依从性也很好，因为用于激活贴片的智能装置还可以与医生进行远程通信以进行数据共享。
对于本领域技术人员将显而易见的是，在不脱离本发明的范围的情况下，可以在上述本发明的特定实施例中进行许多改变和修改。因此，整个前述描述将以说明性而非限制性的意义来解释。

Claims (10)

1.一种活性分子输送系统，包括：
第一基板，包括：
多个驱动电极，
覆盖多个电极的介电层，以及
覆盖所述介电层的第一疏水层；
第二基板，包括：
公共电极，
覆盖所述公共电极的第二疏水层；
间隔物，其将所述第一基板和所述第二基板分离，并在所述第一基板和所述第二基板之间创建微流控区域；
多孔扩散层，其耦合到所述第一基板的与所述第一疏水层相对的基板的一侧上，其中，所述第一基板包括在第一疏水层和所述多孔扩散层之间提供流体连通的通道；
控制器，其可操作地耦合到驱动电极并且被配置为在至少两个驱动电极之间提供电压梯度；以及
与所述多个驱动电极流体连通的储存器。
2.根据权利要求1所述的活性分子输送系统，其中，每个驱动电极耦合至薄膜晶体管。
3.根据权利要求1所述的活性分子输送系统，还包括多个通道，所述多个通道在所述第一疏水层和所述多孔扩散层之间提供流体连通。
4.根据权利要求1所述的活性分子输送系统，其中，所述驱动电极是柔性的。
5.根据权利要求1所述的活性分子输送系统，其中，所述通道包括毛细管或芯吸纤维。
6.根据权利要求5所述的活性分子输送系统，其中，所述毛细管或芯吸纤维涂布有疏水涂层。
7.根据权利要求1所述的活性分子输送系统，还包括与所述多个驱动电极流体连通的多个储存器，以及在所述第一疏水层和所述多孔扩散层之间提供流体连通的多个通道，其中每个储存器仅与一个通道流体连通。
8.根据权利要求1所述的活性分子输送系统，还包括多个储存器和与所述多个储存器中的每一个流体连通的混合区域，并且所述通道在所述第一疏水层和所述多孔扩散层之间提供流体连通。
9.根据权利要求1所述的活性分子输送系统，其中所述多孔扩散层包括丙烯酸酯、甲基丙烯酸酯、聚碳酸酯、聚乙烯醇、纤维素、聚（N-异丙基丙烯酰胺）（PNIPAAm）、聚（乳酸-羟基乙酸共聚物）（PLGA）、聚偏二氯乙烯、丙烯腈、无定形尼龙、取向聚酯、对苯二酸酯、聚氯乙烯、聚乙烯、聚丁烯、聚丙烯、聚异丁烯或聚苯乙烯。
10.根据权利要求1所述的活性分子输送系统，还包括与所述多孔扩散层接触的生物相容性粘合剂。
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