CN101528282B - 用于流体递送和监测体内分析物的柔性贴片 - Google Patents

用于流体递送和监测体内分析物的柔性贴片 Download PDF

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CN101528282B
CN101528282B CN2007800394162A CN200780039416A CN101528282B CN 101528282 B CN101528282 B CN 101528282B CN 2007800394162 A CN2007800394162 A CN 2007800394162A CN 200780039416 A CN200780039416 A CN 200780039416A CN 101528282 B CN101528282 B CN 101528282B
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加里·阿什利·斯塔福德
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Abbott Diabetes Care Inc
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    • A61M5/172Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
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    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
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Abstract

本发明提供了一种可佩戴的导电性纺织品贴片,该贴片可包括用于监测体内分析物和/或将流体递送至体内的多个特征中的任意一个。在本发明的一种实施方式中,单独的贴片安装系统检测糖尿病患者的葡萄糖水平,并响应于葡萄糖测量结果而提供适合剂量的胰岛素。手持式的用户界面可被用于无线控制该系统和/或接收来自其的信息。在贴片的织物中可形成传导通路。可整合至该柔性贴片的部件包括电源、控制器、发送器、天线、温度传感器及其他传感器、流体泵、输液装置、电通路、开关、控制装置、电极、连接器、电阻器、及其他电路元件。这些部件可以嵌入、织入或涂覆于柔性贴片而不是在表面安装,或者同时也安装于表面。本发明还提供了与该柔性贴片系统的应用相关的方法。

Description

用于流体递送和监测体内分析物的柔性贴片
优先权
本申请要求于2006年10月23日提交的名为“用于流体递送和监测体内分析物的柔性贴片”的序列号为11/552,065的美国专利申请的优先权,将其披露内容以引用方式结合于本文以供参考。
技术领域
本发明涉及用于监测活体中的分析物并向其递送流体的医疗器械,诸如监测葡萄糖水平并将胰岛素递送至糖尿病患者。更具体地,本发明涉及整合于柔性贴片中的分析物监测及流体递送系统。
背景技术
近年来,通常通过刺破指尖或身体其他部位进行采血,将血液施加于手持式测量器中的一次性测试条,并允许该测量器和测试条进行血液的电化学测试来确定当前的葡萄糖浓度,从而测量糖尿病患者的血糖水平。这种不连续的体外测试每天通常要至少进行多次。目前正在开发连续的体内葡萄糖监测装置以代替体外装置。这些连续性系统中的一些采用一次性的、经皮的传感器,该传感器被插入到皮肤内以测量间质液中的葡萄糖浓度。该传感器的一部分从皮肤突出,并与通过粘结贴附至皮肤的耐用控制器和发送器单元连接。无线手持式装置与安装于皮肤的发送器和传感器结合使用,以周期性地接收葡萄糖读数,例如每分钟一次。每隔三天、五天或七天,将一次性传感器除去并替换一个新的传感器,将该新的传感器与可再用的控制器和发送器单元再次连接。利用这样的安排,可利用手持式装置连续检测糖尿病患者的葡萄糖水平。于2001年1月16日授予TheraSense,Inc.的美国专利第6,175,752号披露了这种连续式葡萄糖监测系统的详细描述及其使用,将其全部内容以引用方式结合于本文以供参考。
便携式胰岛素泵已被广泛使用,糖尿病患者利用它在较长时间内自动递送胰岛素。目前可用的胰岛素泵采用普通的泵送技术,注射泵。在注射泵中,通过利用精密步进电机使螺杆转动从而使注射器的柱塞向前推进。随着柱塞的前进,流体被挤出注射器,通过导管进入患者体内。胰岛素泵需要以近似连续的方式非常准确地向典型糖尿病患者递送其所需的相对少量的胰岛素(每天约0.1至约1.0cm3)。还可以通过调节该电动机的步进速率来适应不同个体对胰岛素的需求(例如不同的基础率和输注剂量)而在较大范围内容易地调节胰岛素泵的递送速率。除了可更换的胰岛素贮器、螺杆及步进电机之外,胰岛素泵包括电池、控制器及相关电子器件,并通常包括显示器和用户控制装置。典型的胰岛素泵大约为一副牌的大小,并可佩戴在衣服内或利用带夹(belt clip)附着。一次性输液装置与泵连接并将胰岛素递送至患者。该输液装置包括插入穿过皮肤的插管、将插管保持在适当位置的粘结支座、以及将插管连接至泵的一段导管。
上述的连续式葡萄糖监测及胰岛素递送系统具有许多缺点。目前正在开发的安放于皮肤上的发送器的刚性的、平的安装表面会使得佩戴起来很不舒服。另外,由于这些发送器装置与其要安装至的身体部位不配合,从而限制了可将其附着于皮肤或身体部位的应用。目前可用的胰岛素泵是复杂且价值上千美元的昂贵设备。该胰岛素泵的整体尺寸和重量以及输液器管的长度使得目前可用的泵送系统使用起来很麻烦。另外,由于其成本原因,目前可用的胰岛素泵的使用周期长达两年,这使得必须要进行装置的日常维护,诸如为电源重新充电以及重新填充胰岛素。
为了使上述监测及泵送系统显著微型化并进行结合,使其更加可靠、更加简易且更便宜而做的各种尝试均未取得成功。妨碍这种开发努力的限制性因素包括需要周期性替换的传感器、胰岛素供应和电池的系统需求,并且需要减少感染的风险、增加使用者的舒适度且方便使用。
发明内容
根据本发明的一些实施方式的多个方面,分析物监测和/或流体递送系统被设置为具有整合至柔性织物贴片的部件。该柔性部件可设置为佩戴在人或动物的皮肤上。在本发明的一种实施方式中,单独的贴片安装系统检测糖尿病患者的葡萄糖水平,并响应于该葡萄糖测量结果而提供合适剂量的胰岛素。根据本发明的其他方面,可提供手持式的用户界面(interface)用于无线控制该系统和/或接收来自其的信息。
在本发明的一些实施方式中,在贴片的织物中形成传导通路。可与该柔性贴片结合成一体的部件包括但不限于:电源、控制器、发送器、天线、温度传感器及其他传感器、流体泵、输液装置、电通路、开关、控制装置、电极、连接器、电阻器及其他电路元件。这些部件可以嵌入、织进或覆于柔性贴片中而不是在表面安装,或者同时也安装于表面。
柔性贴片可以由聚酯、尼龙、聚氨酯、(菜卡)或其他合成纤维或天然纤维制成。在一种实施方式中,该贴片具有弹性,该性能来自纤维本身的性能,或来自如何将纤维组合而形成贴片。柔性贴片可以是纺织的、无纺的、针织的、纺丝的或由纺织薄膜(textured film)构成,优选形成电活性织物。织物的导电性可来自精细的金属线,其在用于形成贴片的织物的纱线中或沿普通织物纤维被纺进织物中。可替换地,贴片12的电特性可来自作为涂层沉积在织物纤维上的固有导电性聚合物或纳米组分。
根据本发明的一些实施方式的多个方面,该柔性贴片可以是软的、有弹性且透气的,以便在使用中增加患者的舒适感。柔性贴片的织物可以被卷曲、折皱并折叠而不破坏其功能性。柔性贴片还可以被构造成或经涂覆而阻燃、耐水或防水。
根据本发明的一些实施方式的多个方面,柔性贴片系统的多个部分或整个系统本身可以是一次性的,例如在使用一定的预设期间之后和/或在特定的消耗品(例如供应的胰岛素)耗尽之后。例如,仅分析物传感器、输液装置以及贴装粘着物(mounting adhesive)可以是一次性的,而该柔性贴片系统的其他部分是可再用的。在这样的安排中,可以再填充胰岛素或其他流体贮器,和/或包括可拆除的药筒。电通路和/或流体泵的一部分也可以被拆卸并与新的柔性贴片一起再利用,而将用过的贴片的其余部分丢弃。可替换地,根据本发明的多个方面,柔性贴片监测及流体递送系统可以被构造为足够便宜,以便可以将整个系统处理掉并进行周期性替换。这样的安排具有降低与监测和/或流体递送系统的使用相关的安装和再发生的费用的优点。
可以使用本发明的多个方面监测各种分析物。在体液样品中,这些分析物可以包括但不限于乳酸酯、乙酰胆碱、淀粉酶、胆红素、胆固醇、绒膜促性腺激素、肌酸激酶(例如,CK-MB)、肌酸、DNA、果糖胺、葡萄糖、谷酰胺、生长激素、血细胞比容、血红蛋白(例如,HbA1c)、激素类、酮类、乳酸盐、氧、过氧化物、前列腺特异抗原、凝血酶原、RNA、促甲状腺激素、和肌钙蛋白。监测系统还可以被设置为确定药品的浓度,所述药品例如是抗生素(例如,庆大霉素、万古霉素等)、毛地黄毒苷、地高辛、滥用的药品、茶碱、华法林等。这样的分析物可在血液、间质液和其他体液中进行监测。可以递送的流体包括但不限于胰岛素及其他药剂。
附图说明
每一幅附图图解说明了本发明的多个方面。其中:
图1是示出了根据本发明的多个方面构造的柔性贴片系统的示例性实施方式的平面图;
图2是安装在患者P上的图1所示的系统的侧视图;
图3是说明了图1的系统应用于人身上的透视图。
还考虑了图中所示的本发明的各种变型。
具体实施方式
以下的描述集中于本发明的一种变型。本发明的该变型应看作是一个非限制性的实施例。应该理解,本发明并不限于所说明的一种或多种特定变型,当然是可以变化的。本发明可以进行变化,并且可以是在不违背本发明的真实精神和保护范围的前提下替代(目前已知的以及未来开发的)的等同物。另外,可以进行修改以使特定的情况、材料、物质的组合物、工艺、(一种或多种)工艺措施或(一个或多个)步骤适应于本发明的目的、精神或保护范围。
图1示出了根据本发明的一些方面构造的组合的流体递送及分析物监测系统10的示例性实施方式的俯视图,而图2示出了安装在患者P的皮肤上的系统10的仰视侧视图。该柔性织物贴片12构成了系统10的基座(base)。可以向柔性贴片12底面上提供粘结剂,以便在使用中将贴片12固定于患者的皮肤。可以将各个部件贴附于或整合至柔性贴片12中,例如电源14、控制器及发送器模块16、天线18、温度传感器20、流体泵22以及输液装置24。可以将电通路26整合于柔性贴片12中,以便使系统10的部件相互连接。
柔性贴片12可以设置有较厚的区域28,通常接近于贴片的中心,以便为安装部件提供足够的支持。在一种实施方式中,中心区域28为约1mm厚。柔性贴片12的周边区域30可做得较薄,以便促进与皮肤的贴附和粘结,特别是当皮肤移动和伸缩时。
电源14可以是一个或多个太阳能电池、一次性的或可再充电的电池或器件、从患者的分析物产生电能的电化学器件、和/或其他适合用于位于满足柔性贴片12上的部件的电能需要的电源。这种电源可以直接整合入柔性贴片12中,或可移动地插入至连接于贴片12的支持物中。电源14本身可以是柔性,即由一层或多层的纸或织物来构造电池。这样的纸或织物电池可以在电池连通时,通过将该层的一侧上的金属氧化并使氧化物在另一侧上被还原而将化学能直接转化为电能。该金属可以是锌、铝、镍或其他金属,该氧化物可以是氧化锰、或其他氧化物,且该纸或织物层可包含电解质。目前,一些公司,诸如芬兰的埃斯波的Enfucell Ltd.(www.enfucell.com)正在开发这种柔性电池。柔性贴片12本身可包括可用于形成柔性电池的一个或多个层。这样的安排可减少对电池的电连接器的需要,从而有助于使整个系统10更小、更柔软、更加贴合使用者且佩戴更舒适。
控制器和发送器16的电路可以直接整合至柔性贴片12中。可替换地,控制器和发送器16可使用传统的电子部件组装技术来构造,然后物理地并电性连接至贴片12。模块16的这种连接可以是永久的或可拆卸的。通过将模块16的电引线焊接至贴片12上的电引线可实现永久连接。模块16的可拆卸连接可通过传统的电连接器或通过具有连接模块16与贴片12的电通路的搭扣型配件32而实现。模块16优选由电源14提供电能,但可另外包括其自己的电源,或用该电源替代电源14。
天线18优选至少具有一定程度的柔性,以便使贴片12的贴合性和舒适感。天线18可以是与贴片12物理地并电性地连接的分离的元件,但优选由导电层或贴片12的层构成。天线18电连接至控制器和发送器模块16,以便由其向诸如手持式用户界面之类的外部设备发送射频(RF)信号,例如分析物读数。如果将模块16构造成也用于接收信息,则天线18可以被设置为发送并接收RF信号。另外可利用红外(IR)发射器或收发器(未示出)替代天线18或与天线18一起使用,从而使系统10与外部设备之间实现无线通信。还可以为外部通讯提供换能器线圈和/或电线连接器(未示出),从而使用计算机来进行诊断、或上载或下载信息。
柔性贴片12可设置有一个或多个用于容纳经皮分析物传感器的传感器位置34。可同时使用多个传感器以提供多余的分析物读数。可替换地,可以一次插入一个传感器。每一个传感器用于一定预设期间(诸如每三天、五天或七天)之后,可将其拆除,并将新的传感器插入未使用的传感器位置处。优选地,贴片12的所有的传感器位置34都被使用过之后,就将贴片12从皮肤除去并将新的贴片12施加至使用者皮肤上的不同位置。可替换地,可利用新的粘结部分来再使用贴片12的部分。
可以使用自动导引器或插入器装置将经皮分析物传感器插入使用者的皮肤内,诸如在2004年7月8日公开的,公开号为20040133164的美国专利申请第10/703,214号中所描述的那些,其全文引用方式结合于本文以供参考。可利用外部导体或通过柔性贴片12的内部电通路将插入的传感器直接电连接至控制器和发送器模块16。传感器可包括粘合贴装片(adhesive mount)或一些类型的贴装特征,诸如一个或多个搭扣、钩、钳、销、夹或铸模于或连接于贴片的其他手段,以便在使用期间将传感器固定至柔性贴片12或固定至使用者的皮肤。
监测及递送系统10还可以包括用于感知室温、皮肤表面温度或皮下温度的温度传感器20。理想地,测量皮下温度更加精确地校准由分析物传感器所得的读数,因为这些读数一般是对温度敏感的。然而,皮下温度的测量可能是不现实的,因为这通常需要再一次对使用者进行皮肤穿刺。将温度传感器放置于表皮下会导致不适感并使感染机率增大。因此,可将温度传感器20安装至柔性贴片12的底面或结合成一体于柔性贴片12的底面,以测量皮肤的局部表面温度。根据该温度读数,可以估计随着传感器20的穿透深度加深,皮下温度越高。在一种实施方式中,可以利用柔性贴片12内的电通路将温度传感器20与控制器及发送器模块16相连接。
流体泵22,例如用于递送胰岛素或其他药剂,也可位于柔性贴片12上。在该示例性实施方案中,流体泵22包括可拆除的流体贮器36。贮器36可以是一次性的或可再填充的小瓶,耗尽后,该小瓶可以被另一小瓶替代。贮器36也可以是柔性的,以便其内容物排空后会像气球一样塌陷,或者其可以包括柔性隔膜部分。可替换地,贮器36可以是具有柱塞38的刚性圆筒,当该柱塞推进入贮器36中时可将流体压出。致动器40可以是步进电机、形状记忆合金致动器或其他适合用于推进柱塞38或其他使流体流出贮器36的机械装置。形状记忆合金致动器由于其尺寸小、简单且可靠所以是优选的。如果需要的话,还可以较低的制造成本以使泵22与贴片12一样是一次性的。于2004年6月17日以公开号20040115067A1公开的美国专利申请序列号10/683,659提供这样的形状记忆合金驱动泵的详情,其全部内容引用于此作为参考。贮器36并不需要是可从泵22和/或贴片12拆除的,尤其是当贴片12被设计为在流体耗尽后即除去时。
泵22优选由电源14提供电能,但可以具有其自己的电源。可使用内部传导通路26将泵22与电源14和/或控制器和发送器模块16相连接。泵22可以可拆卸地或固定地连接至贴片12。泵22或泵安装基座可通过将贴片材料的一部分夹在泵或基座与相对侧的板(plate)或(一个或多个)垫圈(washer)之间而连接至贴片12。可替换地,泵22或安装基座可利用粘结剂、紧固件或其他适合的手段而连接至贴片12。
在操作中,泵22可接收来自控制器和发送器模块16的控制信号,引起致动器40推动流体从贮器36进入输液装置24的管42,通过插管44而进入患者体内。输液装置24可包括粘合贴装片46,用于将输液装置24的远端固定至贴片12或直接固定至患者皮肤。输液装置24的近端可拆卸地连接至泵22的输出端口48。可在贴片12的薄区域30内设置多个位置50,用于可替换地放置输液装置24。可使用自动插入器或导引器将输液装置24的插管44插入患者体内。优选地,可使用单独的穿刺装置来插入插管44以及上述的经皮分析物传感器。在使用了一段预设期间(通常为3天)之后,可通过揭起(lifting)粘合贴装片46而从患者移除插管44并从泵输出端口48断开导管42从而除去输液装置24。然后可将新的输液装置24放置于另一个位置50处并连接至泵22。如图所示,将输液装置插入位置50与传感器插入位置34尽可能远地分开是有利的,以便使胰岛素或其他流体的输入的局部影响不会干扰葡萄糖监测或其他分析物测量。在一种实施方式中,输液位置50间隔约1英寸。
将系统10部件设置于柔性贴片12上,诸如控制器和发送器模块16、天线18以及泵22的部件的纵轴彼此对齐(align)。这使得整个系统在至少一个方向上呈现高度柔性。由于这些部件可能相当长并且是刚性的,图1中示出的示例性系统10沿示出的y轴比沿x轴更具柔性。在这样的安排下,当y轴与贴片12的施加位置的最急剧弯曲的方向对齐时,贴片12能够更加顺服地配合患者身体的弯曲。图3示出了这样的对齐的一个实施例,其中贴片12贴附于患者P的上臂。如图示,将更顺服的柔性贴片12的y轴水平设置而横贯手臂的弯曲,而将较不顺服的x轴沿手臂的直的纵轴而垂直设置。可将系统10粘结至人体的其他合适部位,诸如躯干、大腿或小腿。在该示例性实施方式中,系统10沿x轴为约4英寸,沿y轴为约3英寸长,且在泵22处具有最大厚度为约0.75英寸。
柔性贴片12本身可以由聚酯、尼龙、聚氨酯、
Figure G2007800394162D00101
(莱卡)或其他合成纤维或天然纤维制成。优选地,贴片12具有弹性,该性能来自纤维本身的性能,或来自如何将纤维结合而形成贴片12。贴片12可以是纺织的、无纺的、针织的、纺丝的或由纺织薄膜构成,优选形成电活性织物。织物的导电性可来自精细的金属线,或者在用于形成贴片12的织物的纱线中或沿普通织物纤维被纺进织物中。可替换地,贴片12的电特性可来自作为涂层沉积在织物纤维上的固有导电性聚合物或纳米组分。
如上文所讨论的,系统10的各个部件可被直接纺织进贴片12的织物中,包括但不限于,复杂的电通路、电路、控制装置、电极、温度传感器及其他传感器、示踪器(trace)、连接器、电阻器、天线、电池、开关及其他部件。开关和其他控制装置可以通过使用多层织物而结合到柔性贴片12中。例如,可以使用三层电活性层。两层外部导电层可包围内部电阻层,在这些层被瞬间按压在一起之前,该电阻层将导电层隔开。
使用如上所讨论的织物,柔性贴片12可以是软的、有弹性的和透气的,以便在使用中使患者感到舒适。现有的织物可提供高的水蒸汽渗透速率(MVTR)。这样的织物可以被卷曲、折皱并折叠而不破坏其功能性。如果需要,贴片12还可以被构造成或经涂覆而具备阻燃性、耐水性或防水性。
对于柔性贴片12,关于适合的织物、一般构造及部件整合方法的其他信息可以从目前正在开发的“智能织物(smart fabrics)”或“导电织物,诸如Textronics(www.textronics.com)、Konarka(www.konarka.com)、Nanosonic(www.nanosonic.com)、Eleksen(www.eleksen.com)以及Eeonyx(www.eeonyx.com)”的公司获得。例如,Eeonyx具有用于利用基于掺杂聚吡咯的固有导电性聚合物涂覆纺织品的专有工艺。该公司在原位聚合该材料-或织物自身的表面上聚合-以使该涂层材料填充了表面中的间隙,并与纤维之间形成了物理键。还参见Joseph Ogando的“Fabrics Get Smart”,Design News,2006年5月15日(www.designnews.com/article/ca6330247.html),将其全文以引用方式结合于此以供参考。
对于有关本发明的其他细节,可根据相关领域技术人员的水平范围来使用材料及生产技术。在其他普遍地或逻辑上采用的本发明的基于方法的方面同样适用。此外,还可考虑提出所描述的发明性变型的任何可选特征并独立地要求保护,或与本文所描述的特征中的任意一个或多个相结合进行保护。同样地,参照单个项目,包括了存在多个相同项目的可能性。更具体地,如本文及所附权利要求中所用的,除非上下文中有清楚的说明,单数形式的“一个”、“一种”、“所述”以及“该”包括了多个所指物。进一步指出所撰写的权利要求排除了任何可选因素。这样,这种表述意在用作这种排他性术语如“单独地”、“仅仅”等的使用的先前基础,或用作一种“消极”限制。除非本文中有其他限定,所有的技术术语和科学术语均具有于本发明所属领域的普通技术人员的通常理解相同的含义。本发明不限于说明书所述的对象,而是仅由所附权利要求所采用的通常术语所限定。

Claims (20)

1.一种体内分析物监测系统,包括:
柔性贴片,构造为佩戴在生物体的皮肤上,所述柔性贴片包含电活性织物;
经皮分析物传感器,与所述柔性贴片结合成一体;
电源,与所述柔性贴片结合成一体;以及
控制器,与所述柔性贴片结合成一体,所述控制器由所述电源提供电能并被设置为控制所述分析物传感器。
2.根据权利要求1所述的监测系统,进一步包括与所述柔性贴片结合成一体的发送器,所述发送器由所述电源提供电能,由所述控制器控制,并被设置为从所述分析物传感器向另外的装置发送数据。
3.根据权利要求2所述的监测系统,进一步包括与所述柔性贴片结合成一体的柔性天线,所述天线用于从所述发送器发送信号。
4.根据权利要求1所述的监测系统,进一步包括与所述柔性贴片结合成一体的收发器,所述收发器由所述电源提供电能,由所述控制器控制,并被设置为从所述分析物传感器向另一装置发送数据并接收来自其他装置的信息。
5.根据权利要求4所述的监测系统,进一步包括与所述柔性贴片结合成一体的柔性天线,所述天线用于发送来自所述收发器的信号并接收来自其他装置的信号。
6.根据权利要求1所述的监测系统,其中,被测量的所述分析物为人体中的间质液葡萄糖。
7.一种流体递送系统,包括:
柔性贴片,构造为佩戴在生物体的皮肤上,所述柔性贴片包含电活性织物;
流体贮器,与所述柔性贴片相连接;
输液装置,与所述柔性贴片相连接并设置用于插入进所述生物体的皮肤内;
流体泵,与所述柔性贴片相连接并与所述贮器及输液装置流体连通,所述泵被设置为通过所述输液装置从所述贮器向所述生物体精确递送预定量的流体;
电源,与所述柔性贴片结合成一体;以及
控制器,与所述柔性贴片结合成一体,所述控制器由所述电源提供电能并设置为控制所述流体泵。
8.根据权利要求7所述的流体递送系统,进一步包括与所述柔性贴片结合成一体的发送器,所述发送器由所述电源提供电能,由所述控制器控制,并被设置为将与所述泵相关的数据发送至另外的装置。
9.根据权利要求8所述的流体递送系统,进一步包括与所述柔性贴片结合成一体的柔性天线,所述天线用于从所述发送器发送信号。
10.根据权利要求7所述的流体递送系统,进一步包括与所述柔性贴片结合成一体的收发器,所述收发器由所述电源提供电能,由所述控制器控制,并被设置为将与所述泵相关的数据发送至另外的装置,并接收来自用于控制所述泵的其他装置的信号。
11.根据权利要求10所述的流体递送系统,进一步包括与所述柔性贴片结合成一体的柔性天线,所述天线用于发送来自所述收发器的信号并接收来自其他装置的信号。
12.根据权利要求7所述的流体递送系统,其中,被泵送的所述流体是进入人体内的胰岛素。
13.一种体内分析物监测和流体递送系统,包括
柔性贴片,构造为佩戴在生物体的皮肤上,所述柔性贴片包含电活性织物;
经皮分析物传感器,与所述柔性贴片相连接;
流体贮器,与所述柔性贴片相连接;
输液装置,与所述柔性贴片相连接并设置用于插入进所述生物体的皮肤内;以及
流体泵,与所述柔性贴片相连接并与所述贮器及输液装置流体连通,所述泵设置为通过所述输液装置从所述贮器向所述生物体精确递送预定量的流体。
14.根据权利要求13所述的体内分析物监测及流体递送系统,进一步包括与所述柔性贴片结合成一体的控制器,所述控制器设置为控制所述分析物传感器及所述流体泵。
15.根据权利要求14所述的体内分析物监测及流体递送系统,进一步包括与所述柔性贴片结合成一体的电源,所述电源被设置为向所述控制器、所述流体泵及所述传感器提供电能。
16.根据权利要求13所述的体内分析物监测及流体递送系统,进一步包括与所述柔性贴片结合成一体的温度传感器,所述温度传感器被设置为测量所述生物体的温度。
17.根据权利要求13所述的体内分析物监测及流体递送系统,其中,所述柔性贴片具有较厚的中心区域以及较薄的周边区域。
18.根据权利要求13所述的体内分析物监测及流体递送系统,进一步包括整合至所述柔性贴片中的导电元件。
19.根据权利要求13所述的体内分析物监测及流体递送系统,进一步包括设置为将来自所述分析物传感器的数据发送至另外的装置的发送器。
20.根据权利要求13所述的体内分析物监测及流体递送系统,其中,所述柔性贴片包括用于容纳所述分析物传感器的多个传感器位置,且其中所述柔性贴片包括用于容纳所述输液装置的多个输注位置。
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