CN104382598A - 一种产生识别器的方法 - Google Patents

一种产生识别器的方法 Download PDF

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CN104382598A
CN104382598A CN201410471075.8A CN201410471075A CN104382598A CN 104382598 A CN104382598 A CN 104382598A CN 201410471075 A CN201410471075 A CN 201410471075A CN 104382598 A CN104382598 A CN 104382598A
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H.黑夫奇
E.斯奈德
B.科斯特罗
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Proteus Digital Health Inc
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Proteus Biomedical Inc
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Abstract

本发明涉及一种产生识别器的方法，所述方法包括：在第一和第二不同材料之间层叠非导电元件以创建叠层部件，其中所述第一和第二不同材料在与导电流体接触时产生电压电势；从叠层部件的周界去除所述第一和第二不同材料的一部分以使非导电元件暴露并且创建边缘；以及将电路固定于在叠层部件中形成的孔径内，其中所述电路电耦合到所述第一和第二不同材料中的每一个上，并且其中由所述第一和第二不同材料产生的电压电势能操作所述电路。

Description

一种产生识别器的方法
本申请是申请号为200980140316.8、申请日为2009.08.13、发明名称为“可摄入电路”的发明专利申请的分案申请。
相关申请的交叉引用
依照美国法典第35篇第119（e）条，本申请要求于2008年8月13日提交的美国临时申请序列号61/088,355的申请日的优先权，其公开内容通过引用并入本文。
背景技术
包括电子电路的可摄入装置已被提议用于包括诊断和治疗应用二者的各种不同医学应用。
这种可摄入装置的示例是可摄入电子胶囊，这些可摄入电子胶囊在它们通过身体时收集数据且向外部接收器系统发射数据。这种类型的电子胶囊的示例在Iddan等人的美国专利号5,604,531中公开，该专利描述了所谓的体内视频照相机。可吞咽胶囊包括照相机系统和用于将感兴趣的区域成像到照相机系统中的光学系统。发射器发射照相机系统的视频输出而接收系统接收发射的视频输出。同样授予Iddan等人的美国专利号7,009,634公开了一种从身体内腔或腔体内获得图像的可摄入成像装置。装置的电子电路部件被内部地通过身体的惰性不可消化外壳（例如，玻璃外壳）包裹。授予Marshall的美国专利号6,800,060公开了一种可摄入数据记录器胶囊医学装置。该公开装置的电子电路（例如传感器、记录器等）安放在由惰性材料制成的胶囊中，且因此可摄入且可通过消化道而不被身体消耗。
在这些装置中，电子电路被保护在外壳或胶囊中，该外壳或胶囊防止在人体中的摄入和排出期间损坏装置的电子电路。
最近，Spoonhauer等人的美国专利申请公开号2007/0008113公开了用于药物摄入监控应用的易碎射频识别（RFID）标签。该申请中公开的RFID标签是配置成在经过身体期间毁坏的简单天线结构。
在某些情形下，需要适合用于可摄入装置的更复杂电路。
发明内容
本发明提供鲁棒的可摄入电路，其中可摄入电路的部件是可摄入的，且在一些情形下是可消化的。因为可摄入电路由可摄入且甚至可消化的部件构成，所以即使当在长期情况下被采用时，可摄入电路导致很小的（如果有的话）不希望的负作用。可摄入电路尤其适于用于例如如可以在包括药物信息启用组合物（pharma-informatics enabled composition）的可摄入事件标记器（IEM）中发现的信号识别器。
根据本发明的一种产生识别器的方法，所述方法包括：在第一和第二不同材料之间层叠非导电元件以创建叠层部件，其中所述第一和第二不同材料在与导电流体接触时产生电压电势；从叠层部件的周界去除所述第一和第二不同材料的一部分以使非导电元件暴露并且创建边缘；以及将电路固定于在叠层部件中形成的孔径内，其中所述电路电耦合到所述第一和第二不同材料中的每一个上，并且其中由所述第一和第二不同材料产生的电压电势能操作所述电路。
本发明的可摄入电路的实施例包括可摄入材料的固体支撑物，该支撑物在其表面上具有一个或多个电子部件。可以存在于支撑物的表面上的部件可以变化，且包括但不限于：例如集成电路形式的逻辑和/或存储器元件；电源装置，例如电池、燃料电池或电容器；受动器（effector），例如传感器、激励器等；例如天线、电极、线圈等形式的信号传输元件；无源元件，例如电感器、电阻器等。支撑物的表面上的一个或多个部件可以以任意方便的配置布局。在固体支撑物的表面上存在两个或更多部件的情况下，可以提供互连。可摄入电路的所有部件和支撑物是可摄入的，且在某些情形下是可消化的。
附图说明
图1示意性示出包括根据本发明的可摄入电路的可摄入识别器。
图2A至2D提供包括根据本发明的可摄入电路的可摄入识别器的组件的视图。
图3A和3B提供包括根据本发明的可摄入电路的可摄入识别器的组件的视图。
图4提供包括根据本发明的可摄入电路的可摄入识别器的组件的视图。
图5提供包括根据本发明的可摄入电路的可摄入识别器的组件的视图。
图6A和6B提供包括根据本发明的可摄入电路的可摄入识别器的组件的视图。
图7A至7B提供为制作根据本发明的一个实施例的装置而采用的分叉层叠工艺的视图。
具体实施方式
本发明提供可摄入电路，其中电路的部件是可摄入的且在一些情形下是可消化的。因为可摄入电路由可摄入且甚至可消化的部件构成，所以即使当在长期情况下被采用时，可摄入电路导致很小（如果有的话）的不希望的副作用。
本发明的可摄入电路的实施例包括可摄入材料的固体支撑物，该支撑物在其表面上具有一个或多个电子部件。可以存在于支撑物的表面上的部件可以变化，且包括但不限于：例如集成电路形式的逻辑和/或存储器元件；电源装置，例如电池、燃料电池或电容器；受动器，例如传感器、激励器等；例如天线、电极、线圈等形式的信号传输元件；无源元件，例如电感器、电阻器等。支撑物的表面上的一个或多个部件可以以任意方便的配置布局。在固体支撑物的表面上存在两个或更多部件的情况下，可以提供互连。
可摄入电路尤其适于用于例如如可以在可摄入事件标记器和药物信息启用组合物中发现的信号识别器。一个示例包括可摄入电路与诸如药丸的特定药品结合使用以确定患者何时服用药品。当药丸被消耗时，可摄入电路被激活且产生被检测的信号，由此意味着药品已被患者服用。
可摄入电路及其制作
如上所述，本发明提供可摄入电路。本发明的可摄入电路包括由可摄入材料制作的固体支撑物以及显示在其表面上的一个或多个电子部件。在给定固体支撑物上存在两个或更多部件的情况下，还存在电耦合这两个或更多部件的导电互连元件。如下面更详细地描述，支撑物上可以存在各种不同类型的部件。另外，可以提供诸如保护层等的一个或多个可选元件。
本发明的可摄入电路可以是独立单元或者它可以合并到另一结构中，例如合并到诸如可以在包括药物信息启用药物组合物的可摄入事件标记器中发现的可摄入识别器中。
如上所述，本发明的电路是可摄入的，其中电路的不同部件由可摄入材料制作。在某些实施例中，电路的可摄入材料中的一种或多种是可消化材料。照此，如果电路存在于将长期摄入的装置中，则材料数量低于长期摄入限制。如果电路合并到将较不常摄入的装置中，则可以基于预期的剂量计划表来选择材料。
如上所述，本发明的可摄入电路的元件除了别的之外还包括固体支撑物、一个或多个电子部件以及互连。
固体支撑物是所有部件都存在于其上的结构。固体支撑物由可摄入材料制作，其中材料是电介质或绝缘材料。它可以由各种材料制作。提供机械强度且可以用作固体支撑物的不可溶解部件的材料包括但不限于：乙基纤维素（例如，Hercules Aqualon或Dow Ethocel）、醋酸纤维素、琼脂、明胶。感兴趣的不可溶解材料包括乙基纤维素、具有从约5至10％的季铵官能团的丙烯酸和甲基丙烯酸酯的共聚物、聚乙烯、聚酰胺、聚氯乙烯、聚醋酸乙烯酯及其任意混合物。也可以存在诸如淀粉、葡萄糖、乳糖的填充物，诸如氯化钠或氯化钾、碳酸盐、重碳酸盐、硫酸盐、硝酸盐、硅酸盐（例如硅化镁）和碱金属磷酸盐的无机盐、以及氧化物（例如，二氧化钛、氧化镁）等。可以用作例如固体支撑物中的分裂剂的可溶解材料包括但不限于：羟丙基纤维素、羟乙基纤维素、羧甲基纤维素、交联甲羧纤维素、羟丙甲纤维素、羟丙基甲基纤维素、甲基纤维素、多糖（淀粉、不同的糖）；聚乙烯醇；树胶（瓜耳胶、黄原胶、阿拉伯胶）；藻酸盐（藻酸钠或藻酸钙）；聚乙烯吡啶酮等。还感兴趣的是增塑剂，例如癸二酸二丁酯、三醋精、柠檬酸三乙酯、聚乙二醇、聚环氧乙烷。感兴趣的可溶解材料包括蛋白质、多糖、聚丙烯酸脂、水凝胶、聚乙烯醇、聚乙烯吡咯烷酮以及这些聚合物的衍生物。在某些实施例中，可以存在增塑剂，其中增塑剂使得较容易处理且调节强度，使得它不是硬的和脆的。还感兴趣的是表面活性剂。在支撑物中还可以存在将使得其在诸如胃的某些生理位置中不可溶解且在诸如肠的其他生理位置中可溶解的环境敏感材料，诸如环境敏感聚合物，例如温度敏感聚合物、ph敏感聚合物（例如，聚甲基丙烯酸酯（例如Degussa Eudragit®））、氧气敏感聚合物、酶敏感聚合物（例如，淀粉、几丁聚糖等）。这种支撑物的实施例是在胃中保持其形状且然后在进入/经过肠时分开的支撑物。还可以存在例如碳酸钠的发泡剂、例如水凝胶聚合物的溶胀剂或例如戊二醛的交联剂。在某些实施例中，支撑物由具有适当属性的食品制作。感兴趣的食品包括但不限于：大豆、乳清、小麦谷蛋白、米淀粉、木薯淀粉、米纸、紫菜、玉米片、马铃薯、面食、生面、水果卷、山楂片、饼干、白明胶和胶质。固体支撑物可以经由任意方便的方案来制作，比如通过经由诸如溶剂浇铸或熔体挤出的许多方法的沉积。
在可摄入电路中还存在用于互连支撑物的（一个或多个）表面上的两个或更多不同部件的一个或多个导电元件。在某些实施例中，例如互连或导线的该导电元件是诸如金、银、石墨、钛、铜等的同质导电和可摄入材料的薄层或条。构成导电元件的材料可以是其总量低于长期摄入限制（即，人们摄入可摄入装置的频率）的任意材料，其中电导率处于所期望的范围内。下面的表1提供范围的示例：
表1
导电元件（即互连）可以沉积在支撑物的表面上以作为同质层（例如，金层）提供两个或更多部件之间的互连。可以采用任意方便的沉积方案，诸如但不限于：蒸发，电镀，电解电镀、电沉积、丝网或喷墨印刷或者其他薄层沉积技术。备选地，可以采用层叠方法，其中各个元件可以安置为片。在其他实施例中，可以采用贴花转印（decal transfer）工艺，其中不同元件中的每一个位于分离的衬里层上。不同元件被转印到固体支撑物，且然后衬里层被去除。对于上述方案中的每一个，可以采用图案化技术。图案化技术的选择将取决于沉积工艺的选择和最终图案所需的尺寸控制，例如，蒸发或电镀与光刻十分兼容。对于层叠方案，可能采用激光图案化，例如其中层被沉积且不希望的部分被切去。在某些实施例中，采用诸如喷墨或丝网印刷的纯添加技术。
代替从同质材料制作导电元件，导电元件可以是浆糊或墨水的异质材料。例如，可以采用导电材料的导电填充物与可摄入粘结剂材料的悬浮液，其中导电材料例如是金、银、石墨等，而可摄入粘结剂材料诸如是聚合物、热固或热塑聚合物。该异质材料可以包含诸如增塑剂、表面活性剂的其他聚合物组分以使得墨水和浆糊更好地流动、更可处理等。在其他实施例中，导电元件是各向同性导电膜，例如，覆盖有导电材料（例如金属）的诸如比如玻璃的材料的惰性颗粒的膜。
支撑物上的导电元件和部件之间的电连接可以以许多不同方式实现。例如，互连和各个部件可以安置在固体支撑物的表面上，且覆盖不同部件和导电元件的导电材料层可以以提供所期望连接的方式沉积。备选地，可以采用可摄入导电胶、浆糊和粘合剂。在某些实施例中，感兴趣的是使用两种（或更多）胶的组合，其中胶之一提供所期望的导电属性且胶之一提供机械强度。另外，可以采用诸如例如在不同部件具有使得它们容易在机械力、压力和温度下接合的合适形状接口的情况下将这些部件按压在一起的机械附连方案。还感兴趣的是激光焊接、超声焊接等。通过例如经由导电盖层的沉积（如上所述，借助于胶，诸如使物品物理保持在适当位置的热塑胶、或者交联的热固胶）而在固体支撑物上机械地保持部件，部件可以相对于固体支撑物的表面固定。激光可以与一些金属或导电元件的混合物一起采用且局部地烧结以在烧结点处形成电接触（例如，其中激光去除粘结剂中的有机材料或使其致密，以留下更加热稳定的导电材料）。
除了上述部件，本发明的可摄入电路还包括一个或多个电子部件。感兴趣的电部件包但不限于：例如集成电路形式的逻辑和/或存储器元件；电源装置，例如电池、燃料电池或电容器；受动器，例如传感器、激励器等；例如天线、电极、线圈等形式的信号传输元件；无源元件，例如电感器、电阻器等。
可以使用各种不同方案在固体支撑物的表面上产生各个部件。例如，在部件是构成在与胃液接触时激活的电池的电极元件的情况下，例如如下所述，电池部件可以直接沉积到固体支撑物上。例如，镁层可以蒸发到固体支撑物的表面上，其中固体支撑物由经得起在该沉积工艺期间出现的温度和压力的（一种或多种）材料制作。电极的不同部件可以沉积到导电层上，该导电层然后附连到固体支撑物。例如，它可以具有薄金片，且CuCl层可以沉积到金上，其中所得到的产品被附连到固体支撑物。不同层还可以经由墨水或浆糊进行沉积。例如，沉积在金上的CuCl结构可以分裂成小颗粒，且可以从这些颗粒制作墨水材料。所得到的墨水材料可以用于把所期望的电极图案印刷或丝印（silk screen）到固体支撑物上。还感兴趣的是采用丝网印刷或喷墨印刷技术的方案。在其他实施例中，沉积未图案化浆料（slurry）。在其他实施例中，采用“卷到卷”或“连续网（continuous web）”方案。
在某些实施例中，可摄入电路包括涂层。该涂层的目的可以变化，例如用于在处理期间、在存储期间或甚至在摄入期间保护电路、芯片和/或电池或者任意部件。例如，人们可能不期望在摄入电路之后使电路暴露于体液。在这种情形下，可能期望的是仅使得电池和发射电线暴露于体液，而电路的其余部分被保护。在这种情形下，可以提供可摄入的且直到装置完成其传输才溶解的电路顶部上的涂层。还感兴趣的是设计成在存储期间保护可摄入电路但是在使用期间立即溶解的涂层。例如，与例如胃液的含水流体接触时溶解的涂层。还感兴趣的是这种保护处理涂层：其被采用以允许使用否则将损坏装置的某些部件的处理步骤。例如，在产生在顶部和底部上沉积有电池材料的芯片的实施例中，产品需要被划片。然而，划片工艺可能刮去电池材料，且还可能涉及将导致电池材料放电或溶解的液体。在这种情形下，可以采用在处理期间防止与电池部件机械或液体接触的、电池上的保护涂层。可食用涂层的另一目的将是控制装置的激活。例如，可以采用位于电池电极上且在与胃液接触时花费某一时间段（例如5分钟）来溶解的可食用涂层。涂层还可以是环境敏感涂层，例如温度或pH敏感涂层、或者其他以受控方式提供溶解且允许人们在期望时激活装置的化学敏感涂层。例如在人们希望延迟激活直到装置离开胃为止的情况下，经受得住胃但是在肠中溶解的涂层也是感兴趣的。这种涂层的示例是在低pH下不可溶解但是在较高pH下变得可溶解的聚合物。还感兴趣的是药物配方保护涂层，例如防止电路被凝胶帽的液体激活的凝胶帽液体保护涂层。
在可摄入电路的某些实施例中存在的另一部件是激活机构，例如其中该激活机构远离电源（例如电池）。这种备选激活元件的示例是在与流体接触时闭合且激活该装置的电路补片（patch）。另一示例是在其被去除之前抑制电路工作的电路补片的反应去除。
如上所述，根据本发明的可摄入电路装置可以以各种不同方式制作。各种不同方案中的任意一种可以在制造电路结构及其部件中采用。例如，可以采用模制、沉积和材料去除，例如，诸如包括表面微机械和体微机械技术的微电子机械系统（MEMS）制作技术的平面处理技术。在制作结构的某些实施例中可以采用的沉积技术包括但不限于：电镀、阴极电弧沉积、等离子喷涂、丝网或喷墨印刷、溅射、电子束蒸发、物理汽相沉积、化学汽相沉积、等离子体增强化学汽相沉积等。材料去除技术包括但不限于：反应离子蚀刻、各向异性化学蚀刻、各向同性化学蚀刻、牺牲剥离蚀刻、例如经由化学机械抛光的平面化、激光烧蚀、电子放电加工（EDM）等。还感兴趣的是光刻方案。在某些实施例中感兴趣的是平面处理方案的使用，其中使用以顺序方式应用于基板的各种不同材料去除和沉积方案，从初始平面基板的一个或多个表面建造和/或去除结构。感兴趣的说明性制作方法在PCT申请序列号PCT/US2006/016370、PCT/US2007/022257、PCT/US2007/082563、PCT/US2008/052845、PCT/US2008/053999和PCT/US2008/077753中更详细地描述，这些申请的公开通过引用并入本文。
在某些实施例中，感兴趣的是用于制备由可摄入电路构成的装置的分叉层叠工艺。在该分叉层叠工艺中，层叠部件被制成与电路部件分离，从而与可以被采用以一起制作不同部件相比允许在处理方案方面的更大自由度，因为方案可以被采用以制作第一部件，其不能用于制作另一部件，反之亦然。在这种分叉层叠方案中，在电路和层叠部件的分离制作之后，这两个部件被组合成单个装置。为了组合两个部件，可以采用任意方便的方案。在某些实施例中，电路部件被固定到层叠部件的接收特征中，且使用诸如导电粘合剂的合适粘合剂而固定在适当位置。下面结合图7A至7B的描述，提供根据本发明的实施例使用该方案来制作可摄入事件标记器的示例。
在图7A中，示出使用“连续网”或“卷到卷工艺”来制备包括可摄入事件标记器的电池元件和虚拟偶极元件（例如边缘（skirt））的初始层叠片。初始层叠片特征在于具有暴露的电池层（例如上和下暴露的电池层），且包括：第一电池层708，例如CuCl层（例如，通过蒸发、电沉积、浆料沉积、丝印、或者喷墨等来产生）；第二虚拟偶极层710（即边缘），安置在电池层的顶部上；第三电流收集器层712，例如Au、Cu或石墨等，其可以是虚拟偶极层的顶部上的边缘上的片或印刷在该边缘上；以及第四电池层714，例如Mg箔。在期望的情况下，这些层中的一个或多个可以在层叠之前分离地制成，使得每个工艺不需要与所有层兼容，例如，电流收集器可以是基于石墨的，使用可以与用于制作其他层的工艺和/或材料不兼容的高温工艺来制成。层可以使用可食用纤维素粘合剂或其他安全压敏粘合剂（包括但不限于硅材料等）而粘在一起。
与层叠部件分离制作的是电路部件。例如，如上所述，电路部件可以使用任意方便的方案来制作。
接下来，如图7B所示，在所得到的层叠部件722中冲印（punch）配置成接收电路部件（例如集成电路（IC））的孔或通道720，以接收电路部件724。例如，如图7B所示，电路部件然后安置在通路中且使用导电粘合剂726固定在适当位置。可以采用各种导电粘合剂，例如填充有导电颗粒或反应（2-部分）胶的聚合物。粘合剂的电导率可以是适度的。在期望的情况下，粘合剂可以覆盖有绝缘粘合剂的最终层。
在上述方案的变型中，采用预冲印下叠层。在该实施例中，IC被放置到预冲印孔上，其中在放置之前该片可以覆盖有压敏粘合剂材料，该粘合剂材料在冲印期间在芯片放置之前去除但在芯片放置之前去除。第二叠层施加于芯片的顶部上且然后例如使用激光在芯片上开口，且例如通过丝网印刷附加地施加顶部导体（例如电池材料）。在此步骤之后，在IEM最终从卷冲印出以组装到片剂或胶囊中之前，以卷到卷工艺使用诸如处理的纸张或塑料的最终非导电层以隔离电池的两侧。
最终，例如图7B中的虚线所示的盘形装置740被冲印出以产生所期望的IEM。
除了别的应用之外，上述分叉层叠方案发现在制作具有虚拟偶极的IEM中的使用，例如如名为“Virtual Dipole Signal Amplification For Pharma-Informatics System”且于2007年9月25日提交的未决的美国临时申请序列号60/975,108中更详细描述的，该申请的公开通过引用并入本文。
包含可摄入电路的装置
本发明的可摄入电路发现在各种不同类型的装置中的使用。可以包括本发明的可摄入电路的装置的一个示例是可摄入识别器。可摄入识别器在公布为WO/2006/116718的PCT申请序列号PCT/US2006/016370；公布为WO/2008/052136的PCT申请序列号PCT/US2007/082563；公布为WO/2008/063626的PCT申请序列号PCT/US2007/024225；公布为WO/2008/066617的PCT申请序列号PCT/US2007/022257；公布为WO/2008/095183的PCT申请序列号PCT/US2008/052845；公布为WO/2008/101107的PCT申请序列号PCT/US2008/053999；公布为WO/2008/112577的PCT申请序列号PCT/US2008/056296；公布为WO/2008/112578的PCT申请序列号PCT/US2008/056299；公布为WO/2009/042812的PCT申请序列号PCT/US2008/077753；公布为WO/2009/070773的PCT申请序列号PCT/US2008/085048；以及PCT申请序列号PCT/US2009/36231；以及未决的美国申请序列号12/126,792和12/126,798中描述；这些申请的公开通过引用并入本文。
这种可摄入识别器的示例是包括电池的识别器。当完成时，电池包括阴极、阳极以及电解液，其中通过例如胃酸的生理流体提供电解液组分。当识别器被摄入且到达胃时，阴极和阳极暴露于胃液。胃液（本身或者当与识别器的干燥导电前驱物介质组分组合时，例如如其公开通过引用并入本文的未决的PCT申请序列号PCT/US2007/082563中所描述的）用作电池的电解液组分。电池的完成对识别器的电路供电，其进而广播可检测信号。
感兴趣的识别器包括组成电池的两个电极（例如阳极和阴极）的两种不同电化学材料。当电极材料被暴露且与诸如胃酸的体液或其他类型的流体接触（单独或者与干燥导电介质前驱物组合）时，作为对两个电极材料所招致的相应氧化和还原反应的结果，在电极之间产生电势差，即电压。由此可以产生伏打电池或电池。因此，在本发明的实施例中，这种电池配置为使得当在其中存在信号产生元件的组合物的物理和化学腐蚀期间两种不同材料暴露于例如胃、消化道等的目标位置时，产生电压。电解液中的两种不同材料处于不同电势。作为示例，铜和锌在放置到电池中时具有不同电势。类似地，金和镁具有不同电势。因此，在两种不同材料之间产生电势差。
在这些实施例的某些中，电池电源可以被看成是利用诸如胃液、血液或其他体液和一些组织的离子溶液中的电化学反应的电源。图1提供具有通过胃液完成的电池的可摄入识别器10的示意性表示。在离子溶液16（其可以单独由目标位置流体构成或者由与干燥导电介质前驱物组合的目标位置流体构成）中存在第一和第二电极材料（12和13）。这种配置创建了施加于电子电路14的低电压（V-）和高电压（V+）。电极的极性由电子电路14的连接需要确定，且所说明的设计仅是一个实施例。因而，对本领域的一位技术人员而言将显而易见，本发明的范围包括电极极性的颠倒，使得电极13代表低电压而电极12代表高电压。电子电路14的两个输出是E0 11和E1 15，它们是顶部表面上的信号传输电极。
电极12和13可以由适合于识别器10将在其中工作的环境的任意两种材料制成。活性材料是具有不同电化学电势的任意材料对，只要它们可摄入即可，例如如上所述。例如，在其中离子溶液16包含胃酸的一些实施例中，电极12和13可以由贵金属（例如，金、银、铂、钯等）制成，使得它们永不腐蚀。合适的材料不限于金属，且在某些实施例中，成对的材料可以选自金属和非金属，例如由金属（诸如Mg）和盐（诸如CuCl或CuI）构成的对。对于活性电极材料，具有合适的不同电化学电势（电压）和低界面电阻的任意配对的物质－金属、盐或插入化合物－是合适的。
感兴趣的材料和配对包括但不限于下面表2中列出的那些。
保护阳极：，诸如Li、Na和其他碱金属的某些高能阳极材料在存在水或氧气时以其纯净形式是不稳定的。然而，如果被稳定化，它们可以用于含水环境。这种稳定化的一个示例是由Polyplus公司（Berkeley，CA）开发的所谓的“保护锂阳极”，其中聚合物膜沉积在锂金属的表面上以保护它以免快速氧化且允许它在含水环境或空气环境中使用。（Polyplus具有其上悬空的IP）。
溶解氧也可以用作阴极。在这种情况下，体液中的溶解氧将在合适的催化表面处诸如在Pt或金处被还原成OH-。还感兴趣的是氢还原反应中的溶解氢。
在某些实施例中，金属之一或二者可以掺杂有非金属，例如用于提高电池的电压输出。在某些实施例中可以用作掺杂剂的非金属包括但不限于：硫、碘等。
在某些实施例中，电极材料是作为阴极的碘化亚铜（CuI）或氯化亚铜以及作为阳极的镁（Mg）金属或镁合金。本发明的实施例使用对人体无害的电极材料。
在某些实施例中，电池具有小形状因数。电池可以约为20mm3或更小，例如约10mm3或更小，诸如1.0mm3或更小，包括0.1mm3或更小，包括0.02mm3或更小。在某些实施例中，电池元件的尺寸被制成具有范围从约0.01mm至约100mm（例如从约0.1mm到约20mm，包括从约0.5mm到约2mm）的宽度；范围从约0.01mm到约100mm（例如从约0.1mm到约20mm，包括从约0.5mm到约2mm）的长度；以及范围从约0.01mm到约10mm（例如从约0.05mm到约2mm，包括从约0.1mm到约0.5mm）的高度。
可摄入识别器10使用电压电势差对电子电路14加电。在一个实施例中，电子电路14调节电导率以创建唯一且可识别的电流签名（signature）。
在某些实施例中，电池具有层叠结构。如上所述，根据本发明，可以采用层叠工艺来制作可摄入电路。这种层叠工艺的示例在图2A至2D中说明。在图2A中，结构21由例如金的圆形金属箔22构成且具有以4个不同象限24形式图案化在其表面上的诸如CuCl的电极材料的图案化区域。CuCl区域24可以经由诸如蒸发的任意方便方案而在箔的表面上产生。还示出了区域26，其缺少电极材料且配置成接收集成电路。在图2B中，结构21放置在固体支撑物23上，例如如上所述，该支撑物由可摄入材料制成。可以以如下方式把结构21放置到支撑物23上：例如通过除了别的方式之外将结构21压装到支撑物23或将结构21粘到支撑物23上以使结构21固定到支撑物23上，两个部件彼此稳定地关联。尽管图2A和2B中示出的顺序说明了结构21在被放置在支撑物23上之前产生的方案，在另一实施例中金属箔22首先放置在支撑物23上。在金属箔22放置在支撑物23上之后，在金属箔22的表面上产生电极材料24的图案化区域。在图2C中，集成电路25安置于区域26中且连接到金属箔22。最终，在图2D中，具有电极切口区域28的覆盖层27（例如，由与支撑物相同的材料制作）稳定地安置在结构21上以产生包括固体支撑物、集成电路和4个不同表面电极的最终可摄入电路装置。在该结构中，金属箔层22用作不同电子部件（即，安置在支撑物的表面上的集成电路和电极）之间的导电互连。
图3A说明可以被采用以构建本发明的可摄入电路装置的层叠工艺的另一实施例。在图3A中，通过首先在衬里层32上提供释放层31，产生结构30。金属层（例如金）33沉积在释放层31的表面上。接下来，电极材料34（例如CuCl）被沉积在金属层33的表面上。最终，绝缘层35安置在电极层34上，该绝缘层可以具有切口区域（未示出），例如如结合图2A至2D的描述所描述的。
在图3B中，在其表面上具有一层第二电极材料37（例如Mg）的集成电路36安置在可摄入支撑物38中。为了组装最终装置，释放层31和衬里层32从结构30去除，以提供暴露的金属层33。该暴露的金属层33然后安置在电路36和支撑物38上以得到最终所期望的装置。
图4说明可以被采用以制作根据本发明的可摄入电路的转印方案。在图4中，首先在可去除的衬里44上形成包括经由互连导电线43连接到5个不同电极42的集成电路41的电路结构40。在产生电路结构40之后，衬里44被去除，且电路结构44安置在可摄入支撑物45的表面上。可以在其中电路结构产生参数（例如，化学药品、温度、压力）与固体支撑物材料不兼容的工艺中采用图4中说明的方案。
图5说明一种变型，其中采用导电墨水来提供可摄入电路装置的不同部件之间的导电互连。在图5所示的装置中，可摄入支撑物51在其表面上显示了4个不同电极（由电极材料构成）52。安置在支撑物51的中央区域的是4个接触焊盘53。互连每个电极到接触焊盘的是导电墨水材料线54。为了完成该结构，集成电路被接合到焊盘53且然后一层保护材料被安置在表面上以留下暴露的电极元件，类似于图2D所示的。
在某些情形下，例如如图6A和6B中说明的，可以在制作本发明的可摄入电路期间采用激光图案化。在图6A中，金属毯状（即，未图案化）层61沉积在可摄入支撑物62的表面上。安置在金属层61的一部分上的是集成电路63。接下来，采用激光图案化来去除部分金属层61以在支撑物62的表面上产生天线结构64和65。
包括本发明的可摄入电路的可摄入识别器发现在各种不同应用中的使用。感兴趣的一个应用是使用可摄入识别器作为可摄入事件标记器（IEM）。可摄入事件标记器可以用于治疗和非治疗应用二者，且在公布为WO/2006/116718的PCT申请序列号PCT/US2006/016370；公布为WO/2008/052136的PCT申请序列号PCT/US2007/082563；公布为WO/2008/063626的PCT申请序列号PCT/US2007/024225；公布为WO/2008/066617的PCT申请序列号PCT/US2007/022257；公布为WO/2008/095183的PCT申请序列号PCT/US2008/052845；公布为WO/2008/101107的PCT申请序列号PCT/US2008/053999；公布为WO/2008/112577的PCT申请序列号PCT/US2008/056296；公布为WO/2008/112578的PCT申请序列号PCT/US2008/056299；公布为WO/2009/042812的PCT申请序列号PCT/US2008/077753；公布为WO/2009/070773的PCT申请序列号PCT/US2008/085048；和PCT申请序列号PCT/US2009/36231；以及未决的美国申请序列号12/126,792和12/126,798中描述；这些申请的公开通过引用并入本文。
这些可摄入事件标记器的公开以及其在那里的应用具体地通过引用并入本文。可摄入识别器的治疗应用是这样的实施例：其中至少在某些情形下，识别器与药物组合物相关联。本发明的医学实施例在其治疗医疗设备方面为临床医生提供重要的新工具：实际传送到体内的药剂的自动检测和识别。这种新的信息装置和系统的应用是多重的。应用包括但不限于：（1）监控患者与规定的治疗方案的顺应性；（2）基于患者顺应性来调整（tailor）治疗方案；（3）监控临床试验中的患者顺应性；（4）监控受控物质的使用；等等。这些不同说明性应用中的每一个在以下申请中更详细评述：公布为WO/2006/116718的PCT申请序列号PCT/US2006/016370；公布为WO/2008/052136的PCT申请序列号PCT/US2007/082563；公布为WO/2008/063626的PCT申请序列号PCT/US2007/024225；公布为WO/2008/066617的PCT申请序列号PCT/US2007/022257；公布为WO/2008/095183的PCT申请序列号PCT/US2008/052845；公布为WO/2008/101107的PCT申请序列号PCT/US2008/053999；公布为WO/2008/112577的PCT申请序列号PCT/US2008/056296；公布为WO/2008/112578的PCT申请序列号PCT/US2008/056299；公布为WO/2009/042812的PCT申请序列号PCT/US2008/077753；公布为WO/2009/070773的PCT申请序列号PCT/US2008/085048；和PCT申请序列号PCT/US2009/36231；以及未决的美国申请序列号12/126,792和12/126,798；这些申请的公开通过引用并入本文。
要理解，本发明不限于描述的特定实施例，因为这些可以改变。还要理解，本文使用的术语仅用于描述特定实施例的目的，且不旨在限制，因为本发明的范围将仅由所附权利要求限制。
在提供值的范围的情况下，要理解，位于该范围的上限和下限之间的每个居中值（至下限单位十分之一（to the tenth of the unit of the lower limit），除非上下文另外明确指示）以及该陈述范围中的任何其他陈述或居中值涵盖在本发明内。这些较小范围的上限和下限可以独立包括在较小范围中且也涵盖在本发明内，服从于陈述范围中任意具体排除的限制。在陈述的范围包括这些限制之一或二者的情况下，排除这些所包括限制之一或二者的范围也包括在本发明中。
除非另外限定，本文使用的所有技术和科学术语具有与本发明所属的本领域一位普通技术人员通常理解的相同意义。尽管在本发明的实践或测试中还可以使用类似于或等价于本文描述的那些的任意方法和材料，但是现在描述代表性说明性方法和材料。
在本说明书中引用的所有出版物和专利通过引用并入本文，就好像每个单独出版物或专利被具体和单独地指示为通过引用并入，且通过引用并入本文以公开和描述与引用的出版物相关的方法和/或材料。任意出版物的引用是用于其申请日之前的公开，且不应解释为承认本发明由于在先发明而不早于这种出版物赋予权利（entitle）。而且，提供的出版物的日期可以不同于实际的出版物日期，其可能需要独立确认。
要注意，如本文中和所附权利要求中使用的单数形式“一”、“一个”和“该”包括复数所指物，除非上下文另外明确指示。还要理解，权利要求可能撰写为排除任意可选元件。照此，这种陈述旨在用作针对与权利要求元素的叙述相关的诸如“单独”、“仅”等的排他性术语的使用或者与“否定”限制的使用的先行基础。
如在阅读本公开时对本领域的技术人员而言将显而易见的，在不偏离本发明的范围或精神的情况下，本文描述和说明的单独实施例中的每一个具有可以容易与任意其他若干实施例的特征分离或与之组合的特征以及分立部件。任意叙述方法可以以叙述的事件的顺序或者以逻辑上可能的任意其他顺序实施。
尽管为了清晰理解的目的，通过说明和举例的方式略为详细地描述了上述发明，但是鉴于本发明的教导对本领域的普通技术人员而言容易显而易见，可以在不偏离所附权利要求的精神或范围的情况下对其做出某些改变和修改。
因此，前面内容仅说明本发明的原理。将意识到，本领域的技术人员将能够设计各种布置，这些布置尽管本文没有明确描述或示出但是体现本发明的原理且包括在本发明的精神和范围内。而且，本文叙述的所有示例和条件语言原则上旨在帮助读者理解本发明的原理和发明人为推动技术所贡献的概念，且要被解释为不限制为这些具体叙述的示例和条件。此外，本文叙述本发明的原理、方面和实施例及其特定示例的所有陈述旨在涵盖其结构和功能等价物二者。另外，旨在这种等价物包括当前已知的等价物和未来开发的等价物，即不管结构如何执行相同功能的所开发的任意元件。因此，本发明的范围不旨在限制为本文示出和描述的示例性实施例。相反，本发明的范围和精神由所附权利要求体现。

Claims (10)

1.一种产生识别器的方法，所述方法包括：
在第一和第二不同材料之间层叠非导电元件以创建叠层部件，其中所述第一和第二不同材料在与导电流体接触时产生电压电势；
从叠层部件的周界去除所述第一和第二不同材料的一部分以使非导电元件暴露并且创建边缘；以及
将电路固定于在叠层部件中形成的孔径内，其中所述电路电耦合到所述第一和第二不同材料中的每一个上，并且其中由所述第一和第二不同材料产生的电压电势能操作所述电路。
2.根据权利要求1所述的方法，还包括：选择所述第一和第二不同材料以当所述第一和第二不同材料与导电流体接触时通过氧化和还原反应而产生伏打电池。
3.根据权利要求2所述的方法，还包括：配置所述电路以产生识别与识别器相关联的唯一信息的可检测信号。
4.根据权利要求2所述的方法，其中所述导电流体是生理流体。
5.根据权利要求1所述的方法，还包括：将所述识别器固定到药品以产生标签产品，使得所述电路的激活是所述标签产品的药品与生理流体接触的指示。
6.根据权利要求5所述的方法，还包括：使用涂层密封所述标签产品以使所述标签产品与所述生理流体进行隔离达预定时间段，直到所述涂层被所述生理流体溶解为止，由此允许所述标签产品达到该标签产品暴露于生理流体时的目标位置。
7.根据权利要求1所述的方法，还包括：在所述第一和第二不同材料中的至少一个与所述非导电元件之间层叠电流收集器元件。
8.根据权利要求1所述的方法，还包括：形成通过所述叠层部件的孔径以在所述孔径内接收所述电路。
9.根据权利要求1所述的方法，还包括：使用导电粘合剂将所述电路部件固定在所述孔径内。
10.根据权利要求1所述的方法，还包括：去除包含所述电路的所述叠层部件的一部分以产生所述识别器。
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