CN1471413A - 用于患者注射的装置、系统和方法 - Google Patents

用于患者注射的装置、系统和方法 Download PDF

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CN1471413A
CN1471413A CNA018181600A CN01818160A CN1471413A CN 1471413 A CN1471413 A CN 1471413A CN A018181600 A CNA018181600 A CN A018181600A CN 01818160 A CN01818160 A CN 01818160A CN 1471413 A CN1471413 A CN 1471413A
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�и���J������˹
克里斯托弗·J·弗莱厄蒂
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    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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    • A61M5/16804—Flow controllers
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Abstract

一种用于向患者输送流体的装置，包括出口、用于使流体从容器流到所述出口的分配器、可编程而基于来自独立的遥控装置的流动指令使流体流到所述出口的局部处理器，和连接于所述局部处理器、用于从独立的遥控装置接收流动指令并将流动指令输送到所述局部处理器的无线接收器。所述装置还包括没有用于为所述局部处理器提供流动指令的用户输入部件的外壳，以便降低所述装置的复杂性和成本，从而使所述装置实际上可以一次性使用。本发明还描述了包括所述流体输送装置、独立的遥控装置、用于经由皮肤输送流体药物的附件的系统和套件。另外还公开了使用所述流体输送装置注射流体药物的方法。

Description

用于患者注射的装置、系统和方法
相关申请
本申请要求2000年9月8日提交的美国临时专利申请60/231,476的优先权，该申请转让给本发明的受让人，在此通过引用而包含其内容。
技术领域
本发明涉及医用装置、系统和方法，特别涉及小型、低成本、便携式的注射装置和方法，用于实现以精确、复杂、可编程的流动形式向哺乳类患者输送治疗液体。
背景技术
现在，很多疾病和其它身体不适需要通过多种药物进行治疗，包括固体或液体形式的药品、营养制剂、生物提取或活性成分、基于荷尔蒙和基因的材料及其它物质。在输送这些药物时，经常需要绕过哺乳类患者的消化系统，避免由于消化道或肝脏中催化酶的作用而降低了活性成分的作用。通过肠道以外的途径输送药物称作肠道外输送。通常希望肠道外输送液体形式的药物，以提高所输送物质的作用，保证未被改变的药物以有效的浓度到达预期部位。而且，可以避免其它输送路线带来的不期望的副作用，例如系统毒性。
通常，药物可以仅以液体形式下使用，或者液体形式具有期望的特点，而固体或丸体不能实现。输送液体药物最好通过静脉或动脉直接注射进入循环系统，进入皮下组织或直接进入器官、肿瘤、内腔、骨骼或体内其它部位的特定位置。
液体药物的非肠道输送进入体内通常使用针头和注射器进行丸剂注射(bolus injection)完成，或通过重力连续驱动的分配器或皮肤贴技术完成。丸剂注射经常难以满足患者的临床要求，通常需要在特定时间内给予他们比期望剂量更大的单次剂量。通过重力输送系统持续输送药物影响了患者的移动性和生活方式，并将治疗限制在过于简化的流速和流量剖面上。皮肤贴对于所输送的药物有特殊要求，特别是它涉及药物的分子结构，并且与重力输送系统相似，对于药物投放的控制非常有限。
已经研制出移动注射泵，用于为患者输送液态药物。这些输液装置具有提供高级的流体输送剖面的能力，完成丸剂注射、连续注射和可变流速的输送。这些注射能力通常使药物和治疗更有效，且对患者身体系统的毒性更小。移动注射泵的应用示例是用于治疗糖尿病的胰岛素的输送。这些泵可以在连续的基础上以及丸剂的基础上输送胰岛素，如Schneider等的美国专利US4,498,843中所公开的那样。
移动注射泵通常与容纳所述液态药物的储存器一起使用，例如药筒或注射器，并使用电子—机械泵送或计量技术，通过管道输送药物，从所述注射装置到刺入或穿过患者皮肤的针头。所述装置通过位于装置外壳上的机电按钮或开关控制和编程，并由患者和临床医生使用。所述装置包括通过文本或图形屏幕的可视反馈，例如称为LCD的液晶显示器，还可包括警报或告警灯以及声音和振动信号和报警信号。所述装置可以系上或在口袋里，或用带子捆到患者身上。
目前，可用的移动注射装置价格昂贵，难以编程和准备注射，且容易体积大、重而且容易损坏。这些装置及其容器的填充很困难，且当旅行或仅是去工作时，需要患者携带指定药物和填充附件。基于所输送的药物和患者的状况，这些装置的精度和安全要求非常重要。因此，为了按预计长期使用，所述装置需要专门管理、维护和清洁，以确保适当的功能性和安全性。所述装置通常售价4000美元到6000美元，要求维护保养该设备四年或更多年，以调整费用。由于成本的原因，装置的更换不容易或不实际。所述设备的的任何损坏，例如，由于掉落造成的，不仅会带来维修和更换的成本，还会造成一定时期内的治疗中断。所述装置的高昂成本是批准和指定使用所述设备的保健供应商的考虑因素，限制了使用该设备的患者和治疗人数的扩大。
因此，显然需要一种可编程而且可调整的注射系统，该注射系统精确可靠，可以为临床医生和患者提供一种小型、成本低、重量轻的便于使用的选择，为患者输送液体药物。
发明内容
本申请人已经确定，需要一种可编程而可靠输送可变流量剖面的液体药物的、高级的移动注射装置，而且小型、重量轻、成本低。较小且较轻的装置便于携带，而且使患者更舒适，甚至能够使所述装置象皮肤贴一样粘附在患者皮肤上。通过降低保健供应商、医院和患者就医中心，以及患者本身的财务负担，低廉的装置为所述装置的使用提供了更大的适应性。另外，低成本装置使一个或多个替代装置的维护更实际。如果所述主要装置遗失或功能失常，替代装置的可用性避免了高额维修费用和中断时间。
本发明的一些方面能使成本显著降低，而实际上可以使整台装置一次性使用，可每二到五天频繁更换。一次性装置可以在生产商处预装药物，而且不需要长期装置所需的日常清洁和维护，大大简化了患者的使用。近年来，一次性照相机已经变得非常普遍，与之类似，另一优点是每次购买一次性使用的流体输送装置，都是最新的技术水平。长期使用的装置可能在一年后，制造商的新款出现时就已经过时，而该最初装置刚刚度过寿命周期的百分之二十五。
因此，本发明提供了一种用于向患者输送流体的装置，包括适于连接于经由皮肤进入患者的工具上的出口组件，用于使流体从容器流到所述出口组件的分配器，连接于所述分配器、并可被编程而基于来自独立的遥控装置的流动指令使流体流到所述出口组件的局部处理器，和连接于所述局部处理器、用于从独立的遥控装置接收流动指令并将流动指令输送到所述局部处理器的无线接收器。所述装置还包括容纳所述出口组件、分配器、局部处理器和无线接收器的外壳。为了减小所述装置的尺寸，复杂性和成本，所述外壳没有用于为所述局部处理器提供流动指令的用户输入部件，从而所述装置实际上可以一次性使用。
根据本发明的一方面，所述流动指令致使在预定的时间内有预定速率的流体。根据另一方面，预定的流体速率包含基本速率。
根据本发明的另一方面，所述流动指令导致在预定的时间内有预定体积的流体。根据另一方面，预定的体积包含丸剂体积。
根据另一方面，所述装置包括至少一个用户接口部件，该部件可从所述外壳外部操作而使预定时间内有预定体积的流体流动，且不依赖于局部处理器。根据另一方面，所述装置包括至少一个用户接口部件，该部件可从所述外壳外部操作而用于阻塞流体流到所述出口组件。
根据本发明的另一方面，所述装置包括连接于所述局部处理器的电源。根据另一方面，所述装置包括连接于所述局部处理器的发射器，用于从所述局部控制器向独立的遥控装置发射信息。根据另一方面，所述外壳没有用于从所述局部处理器提供信息的用户输出部件。根据另一方面，所述出口组件包括管状部件，用于经皮肤进入患者。根据另一方面，所述装置包括容器。
本发明还提供了一种系统，包括如上所述的流体输送装置，还包括独立的遥控装置，该遥控装置包括遥控处理器、连接于所述遥控处理器而使用户可以向所述遥控器提供指令的用户输入部件、和连接于所述遥控器的发射器，用于向所述流体输送装置的接收器发射指令。这样，所述遥控器可以使用户，例如患者、护士或医生远距离设定所述流体输送装置的程序，向患者提供所需的流体注射。
本发明还提供了另一种用于向患者输送流体的装置，包括用于连接于经由皮肤进入患者的工具上的出口组件，用于使流体从容器流到所述的出口组件的分配器，连接于所述分配器、并可被编程而基于流动指令使流体流到所述出口组件的局部处理器。所述局部处理器还可以编程而提供流动信息，而无线发射器连接于局部处理器，用于将所述流动信息发射到独立的遥控装置。外壳容纳所述出口组件、分配器、局部处理器和无线发射器，没有用于从所述局部处理器向用户提供流动信息的用户输出部件。
参照下述结合附图的详细说明及示例，可更好地理解本发明的这些方面及其它特点和优点。
附图说明
图1是根据本发明的流体输送装置的第一示例性实施例的侧剖视图；
图2是根据本发明的遥控装置的第一示例性实施例的透视图，用于与图1所示的流体输送装置一起使用；
图3是根据本发明的流体输送装置的第二示例性实施例的侧剖视图；
图3a是用于图3的所述装置的分配器的放大的局部剖视图，示出了在打开入口阀时适于填充的空的储存器；
图3b是用于图3的装置的分配器的放大局部剖视图，示出了在打开出口阀时适于分配出流体脉冲的填充的储存器；
图4是根据本发明的流体输送装置的第三示例性实施例的侧剖视图；
图4a是图4的所述装置的容器腔室的放大侧剖视图；
图4b是图4的所述装置的容器腔室的一部分的放大的底视图；
图5是根据本发明的流体输送装置的第四示例性实施例的侧剖视图；
图5a是图5的所述装置的底视图；
图6是根据本发明的流体输送装置的第五示例性实施例的侧剖视图，示出位于患者的皮肤和皮下组织外表面上；
图6a是图6的所述装置的底视图；
图7是根据本发明的流体输送装置的第六示例性实施例的侧剖视图；
图8是根据本发明的流体输送装置的第七示例性实施例的侧剖视图；
图8a是图8的所述装置的顶视图；
图9是根据本发明的流体输送装置的第八示例性实施例的侧剖视图；
图9a是与图9的所述装置的出口组件适应的注射装置的透视图；
图10是根据本发明的流体输送装置的第九示例性实施例的侧剖视图，其中所述装置有示为处于打开状态的机械式止动按钮；
图10a是图10的所述装置的止动按钮组件的放大剖视图，所示出的按钮示为处于封闭状态；
图11是根据本发明的流体输送装置的第十示例性实施例的侧剖视图；
图11a是图11的所述装置的丸剂按钮组件的放大剖视图；
图12是根据本发明的遥控装置的另一示例性实施例的侧剖视图；
图12a是图12的遥控装置的侧剖视图；
图13是根据本发明的流体输送装置的第十一示例性实施例的顶视图；
图13a是作为根据本发明的套件的一部分而将与图13所示的流体输送装置结合的遥控装置的顶视图；
图13b是作为根据本发明的套件的一部分而将与图13所示的流体输送装置结合的胰岛素药筒的顶视图；以及
图13c是作为根据本发明的套件的一部分而将与图13所示的流体输送装置结合的无菌注射装置的顶视图。
在这些附图中，相同的附图标记表示相同或相应的部件和元件。
具体实施方式
下面详细描述根据本发明构造的流体输送装置、系统和套件的特定实施例和示例，以及使用所述装置、系统和套件的方法。本发明的流体输送装置、系统和套件可以输送的流体类型包括，但不仅限于，胰岛素、抗生素、营养液、总胃肠外营养或TPN、止痛剂、吗啡、激素或激素类药物、基因治疗药物、抗凝血剂、镇痛药、心血管药物、AZT或化学疗法药物。本发明的流体输送装置、系统和套件适用于处理的医疗类型包括：糖尿病、心血管疾病、疼痛、慢性疼痛、癌症、AIDS、营养类疾病、Alzheimer氏病、ALS、肝炎、帕金森氏病或痉挛。
在图1中，示出了根据本发明的流体输送装置10。所述装置10包括适于连接在经由患者皮肤进入的工具上的出口组件70，用于使流体从容器30流到所述出口组件的分配器40，连接于所述分配器、且可编程而基于来自独立的遥控装置(图2示出了其示例)的流动指令使流体流到所述出口组件的处理器或电子微控制器(下文称作“局部”处理器)50，以及连接于所述局部处理器的无线接收器60，该接收器用于从独立的遥控装置接收流动指令，并将流动指令输送到所述局部处理器。所述装置还包括容纳所述出口组件70、分配器40、局部处理器50和无线接收器60的外壳20。为了减小所述装置10的尺寸、复杂性和成本，所述外壳20没有用于向所述局部处理器50提供流动指令的用户输入元件，比如连接于所述处理器50的外部按钮，而使所述装置更小并且实际上可以一次性使用。
在图1的示例性实施例，所述装置10还包括包含在所述外壳20内且连接于所述分配器40上的容器30。所述容器30具有可伸缩式设计，例如金属波纹管或由可伸缩材料比如硅橡胶制成。选择所述容器30的体积，以最适合所述流体输送装置10的治疗应用，这些应用场合受到一些因素的影响，比如需输送药液的可行浓度、在重新灌装或抛弃所述流体输送装置10的之间的可接受时间、尺寸限制和其它因素。对于I型糖尿病，例如，小于5毫升的容器，优选的是2到3毫升是合适的。
所述局部处理器50包含所有计算机程序和必要的电路，以使用户可以编程所需的流动方式和根据需要调整所述程序。这种电路可以包括一个或多个微处理器、数字和模拟集成电路、电阻器、电容、晶体管或其它半导体以及本领域技术人员已知的其它电子部件。所述局部处理器50还包括程序设计、电路和内存，而以所需的时间间隔适当启动所述分配器。在图1所示的示例性实施例中，包括电源80，例如电池或电容，为所述局部处理器80供电。
当所述局部处理器50启动了所述分配器40时，特定量的流体通过出口组件70从所述流体输送装置10流出。所述出口组件70可以包括经由皮肤进入患者体内的元件，例如，针头或软插管，或可适于连接在包含经由皮肤的输送装置的标准注射装置上。
如图所示，所述外壳20没有用于向所述局部处理器50提供流动指令的用户输入部件，例如位于所述外壳外表面21上的机电开关或按钮，或由患者通过所述局部处理器50调整程序设定流速的接口。为了编程、调整程序设计、或将用户输入传送到所述局部处理器50，所述流体输送装置10包括无线通信元件、或用于从独立的遥控装置接收用户输入的接收器60，例如图2中的独立的遥控装置100。信号可以通过遥控装置100的通信元件(未示出)发出，遥控装置100可以包括或连接于天线130，如图2所示，天线130位于所述装置100的外部。
所述遥控装置100具有用户输入部件，包括机电开关阵列，例如所示的薄膜键盘120。所述控制装置100还包括用户输出部件，包括可视显示器，例如液晶显示器(LCD)110。尽管在图2中没有示出，但所述遥控装置100都含有自己的处理器(在下文中称为“远程”处理器)，连接于薄膜键盘120和液晶显示器110上。所述远程处理器编程而接收用户从薄膜键盘120的输入，并将用户的输入翻译成“流动”指令，传输到所述流体输送装置10，并编程将用户输出发送到液晶显示器110上。
用户例如患者或临床医生可以这样给所述流体输送装置10编程，通过向所述遥控装置100输入信息，然后所述遥控装置100利用键的冲击或按钮下压或多个键组合冲击的方式将信息下载到所述装置10的接收器60。复杂的流动算法、丸剂输送和其它所需的药液注射要求可以通过向所述遥控装置100输入随后传递到所述流体输送装置10的信息来实现。通过使用一个或多个特征比如标准的同步交换协议、冗余传输和其它本领域技术人员已知的通信确认方法，所述流体输送装置10的局部处理器50可以确认通信为可接受的。
在所述流体输送装置10中缺少用户接口，例如机电开关，导致实际上降低了所述装置10的成本、尺寸、重量。缺少用户接口还使所述装置10外壳的外表面21相对比较光滑，因此简化了清洁，并避免了饰品或衣服例如毛衣挂在所述装置上。因为所述遥控装置100还包括可视显示器110，所述流体输送装置10可以没有信息屏，而进一步降低了成本、尺寸和重量。缺少用户接口，例如机电开关和信息屏，大大简化了所述流体输送装置10的设计，并使所述装置10可以更加灵活地制造，更耐损坏。
在图3示出了根据本发明的流体输送装置10的另一示例性实施例，其中，所述容器30由柔性材料制成，并封装在容器腔室35内，容器腔室35由所述外壳20和容器壁27外壳之间的空间确定。所述柔性容器30被压缩元件33和压缩弹簧34压缩而位于受压状态，压缩弹簧34位于压缩元件33和所述外壳20之间。受压的柔性容器30导致所述容器30内的流体压力高于大气压。在优选实施例中，所述压缩元件33的横截面积接近所述容器30的横截面积。
或者，所述外壳20可以包括柔性悬臂梁，该梁与所述容器30相接触，在所述容器30内产生高于大气压的压力。在另一替代例，所述容器腔室35可以密封并填充气体、或蒸汽一流体混合物，使所述容器30内的流体处于压力高于大气压的状态。所述气体可以是空气，所述蒸汽一流体混合物可以是氟利昂。氟利昂的蒸汽一流体混合物给设计带来了优点，如果所述流体输送装置10保持在接近恒温的温度下，氟利昂的蒸汽一流体混合物接近保持恒压。在另一可选实施例中，封在所述容器腔室35中的气体的量可以选择成，对于所述容器30完全充满到空的状态，所述容器30的压力等于或低于大气压。如果所述容器30中的流体维持在等于或低于大气压的压力下，则所述分配器40应为泵的方式，例如蠕动驱动泵，用于将流体从所述容器30中泵送到所述出口组件70中。
所述容器30中可以由所述装置的生产商或合作的药物生产商预填充，或者可以包含填充组件31构成的外部填充装置。如果所述流体输送装置10由生产商预填充，则可以在所述局部处理器50中设有包含多种关于预填充药物信息的内存，包括但不仅限于流体的类型或名字、浓度和体积。
所述填充组件31包括针头插入隔膜32。在最后的生产工艺中，所述容器30和其它流体通路部件可以处于真空下，以简化患者对所述流体输送装置10的填充和装填。所述针头插入隔膜32可以由可重新密封的弹性体构成，例如硅胶，使针头可以刺破隔膜向所述容器30中添加流体，并在针头退回后重新封装。另一种针头插入隔膜32是一种标准流体接头，例如Luer连接器，该连接器可以与一种单向阀例如鸭嘴阀(未示出)结合而固定于所述填充组件31上。患者可以将填充有液体药物的注射器连接在Luer连接器上，填充所述流体输送装置10。所述填充组件31可以设计成使患者仅能一次性填充所述流体输送装置10，例如当将注射器移开时折断Luer接头。
所述分配器40与所述容器30液体连通。当所述装置10设有加压容器30时，例如图3所示的示例性实施例，所述分配器可以包括连接于所述容器的入口阀41和连接于所述出口组件70上的出口阀42，以及连接在入口阀41和出口阀42之间的存储器(accumulator)43。因为所述容器30中的流体维持在高于大气压的压力下，所述入口阀41的打开使存储器填充到所述容器的压力，然后所述入口阀41关闭。在由所述局部处理器50的程序和来自所述遥控装置的指令确定的适当的时间，所述出口阀42可以打开将流体分配到处于患者压力或大气压状态下的所述出口组件70。届时所述存储器43将处于大气压力下，而所述出口阀42关闭，准备重复另一循环。
图3的示例性实施例中的所述分配器40不能对所通过的流体产生驱动或泵送力，但更适于作为测量装置，使流体脉冲从所述压力容器30，通过所述分配器40，到达大气压下的所述出口组件70。所述分配器40的入口阀41和出口阀42受所述局部处理器50的控制，该处理器包括电子程序设计、控制器和电路，实现对所述分配器40的流体输送精密的程序设计和控制。
图3a示出了处于大气压力下的带有所述存储器43的分配器40。示出的存储器的隔膜44处于非膨胀状态，仅仅由大气压力导致。所述入口阀41关闭，所述出口阀42可以关闭或打开，但所述出口阀42必须已经打开，因为最后一次所述入口阀41是打开的。图3b示出了所述出口阀42关闭，所述入口阀41打开的状态。因为来自所述容器30的流体压力升高，所述存储器隔膜44膨胀，因此所述存储器43的体积增加了存储器体积45。所述入口阀41关闭后，所述出口阀42可以打开，释放所述存储器体积45并使所述存储器隔膜44缩回到图3a所示的位置。
所述分配器40的入口阀41和出口阀42以及所述局部处理器50设计为可以阻止两个阀门同时打开，避免所述容器30直接不断地流到所述出口组件70。防止两个阀门同时打开非常重要，可以通过机械方式、电子方式或同时使用两种方式实现。可以在所述分配器40的设计中，或在所述局部处理器50设计中实现这种防止，或同时使用两种方式。
每次启动时，图3，3a，3b中示出的所述分配器40释放出一定的流体体积脉冲，称为脉冲体积(PV)。所述PV由所述储存器43和所述存储器隔膜44的性质、材料和构造确定。注射装置输送的PV通常选择为比临床的有效体积略小。使用每毫升100单位的胰岛素时，PV为小于2毫升，典型的为0.5毫升。如果所述流体输送装置10通过遥控装置100程序设定为每小时输送2单位，所述分配器40将每小时输送40个脉冲，或每1.5分钟输送一个脉冲。如果所述的PV足够小，这种脉冲式流动被认为是连续的。其它药物或浓度可以允许使用大得多的PV。通过调整脉冲之间的时间间隔，可以获得不同的流动速率。为了给出一个固定的体积或丸剂，可以连续快速给出多个脉冲，直到达到所述的丸剂体积。
所述PV可以不总是在所述流体输送装置10精度需求范围内的常数。影响PV的一个因素是容器压力。所述流体输送装置10可以包括用于监控容器压力(RP)的装置，并且可以调节脉冲之间的时间间隔，以获得所需的流动形式。这种补偿的一个示例是，当所述PV减少时，可以降低脉冲之间的时间间隔，维持程序设定的流速。用于监控这些参数，例如容器压力RP的方法如下所述。另一种监控容器压力的方法为监控所述容器30的体积。每次输送一个脉冲或一系列脉冲，测量容器的体积可指示出对于单次脉冲和累计脉冲是否输送了适当的流体量。系统也可以设计为检测到误差时，补偿流体流动。一种容器体积转换方式的示例如下所述。
优选的是，所述通信元件60从使用无线电频率或其它无线通信标准和协议的所述遥控装置100接收电子通讯信息。所述传输信息包括编码或编码包，所述局部处理器50使用编码确认信息是否正确地接收，类似于标准电话调制解调通信的方式。可以包含更复杂的编码，使信息自校正或显示坏信息的区域。在更优选的实施例中，所述通信元件60是双向通信元件，包括发射器和接收器，使所述流体输送装置10可以将信息发回到所述遥控装置100。在这种实施例中，所述遥控装置100也包括集成通信元件60，该元件含有发射器和接收器，用于使所述遥控装置100可以接收由所述流体输送装置10发出的信息。
所述电源80可以集成到所述流体输送装置10中，且用户不可操作。然而，在另一实施例中，所述电源80是可更换的，例如，可更换的干电池。在另一实施例中，所述电源80可以由集成的电池或电容器构成，用于所述装置10的低功率部件，例如，电子内存，用户插入的电池用于为所述装置10的其余部分供电。其它需要电能的部件有所述通信元件60、所述分配器40和其它部件，例如传感器或转换器。
从图3中可以看出，所述装置可以包括传感器或转换器，例如容器体积转换器37。类似的转换器在Kamen等的美国专利US5,533,389中描述。图3还示出了压力转换器221，它位于容器外壳壁27上，与所述容器30的一部分接触。所述压力转换器221可以包含力敏电阻技术，例如使用加利福尼亚州的Camarillo的Interlink公司制造的。容器转换器37或压力转换器221可以将信息传输到局部处理器50，指示怎样、何时启动所述分配器40，或指示其它决定流动的参数和条件，例如所述容器30是否空或泄漏，或从所述容器分配的流体是否太多或太少等。
图4示出了所述流体输送装置10的另一示例性实施例，它含有弹性护套36，用于压缩所述容器30而达到大气压之上。所述容器护套36由弹性材料构成，在空状态时具有非常小的不扩张的内部体积，不大于所述容器30的体积。当充满时，所述容器护套36膨胀而支撑容器30，并弹性压缩直至容器30完全变空。或者，当弹性容器30为空时，可以具有非常小的内部体积，通常低于100毫升，在填充过程中膨胀，在所述容器内产生高于大气压的压力，直到所述容器30重新为空，因此不需要所述容器护套36。在图4中，所述流体输送装置10包括Luer连接器71，用于将经由皮肤的标准输送装置连接在所述出口组件70上。
因为所述流体输送装置10可以靠近哺乳类患者佩戴，甚至附着在哺乳类患者的身体上，所以希望避免所述容器30内的流体温度朝患者的体温升高。在一个实施例中，所述容器腔室35可以密封并置于真空中，与保温瓶的结构类似。所述容器腔室35的内表面可以涂敷有反射材料，也与保温瓶类似。或者，所述腔室35可以填充绝热材料，例如低导热性泡沫，具有足够的空腔尺寸而使所述容器30膨胀到最大的填充容积。从图4a和4b中可以看到通风孔38，贯通所述外壳20并且在远离患者的所述装置10侧面的所述容器腔室35区域的外壳外表面21。所述通风孔38使所述容器腔室35与室温相通，这样可以冷却容器30。
图5示出了所述流体输送装置10的另一示例性实施例，包括第二容器90，它与第二分配器91流体连通。所述附加容器90可以在生产加工阶段填充或者可以包括类似填充组件31的填充装置。所述附加分配器91可以包括独立的控制器，或者使用同一个局部处理器50控制。所述附加分配器91末端连接于在所述主分配器40和所述出口组件70之间延伸的管腔74。与所述主分配器40类似，所述附加分配器91设计和控制成用于防止流体从所述附加容器90中自由流动到所述出口组件70。
所述第二容器90可以填充不同于所述主容器30中的药品、所述主容器30中的药品稀释液或任何惰性物质。来自于所述附加容器90中的流体可以用于稀释来自于所述主容器30中的流体，而提供更复杂的或加成治疗，或者甚至于通过以比所需的主容器30中的流体注射更高的频率使惰性物质流动而维持经由皮肤的流路顺畅。
参照图5a，所述装置还包括由连接于所述出口组件70的经由皮肤的微型穿透器75构成的连接于经由皮肤的患者进入工具。所述经由皮肤的微型穿透器75包括系列微型针头或其它微型穿透器，不使用标准针头就可以使流体经由皮肤进入患者体内。例如，在Kamen等的美国专利5,983,136中示出了类似的经由皮肤的微型穿透器。
所述装置10中还包括在所述外壳20外表面上的粘结层201，用于将所述装置10直接定位在患者皮肤上。优选的是，所述粘结层201以连续的椭圆形围绕所述出口组件70，在患者皮肤周围提供保护性密封。所述外壳的粘结层201可以使用用于绷带或电手术返回垫(electro surgery returnpad)的材料，例如由Tyco/U.S.Surgical公司的Valley Lab分部生产的材料。
图6和图6a示出了所述流体输送装置10的另一示例性实施例，它包括外壳200，所述外壳具有凹面29，用于在所述流体输送装置10与患者的皮肤210之间产生气穴。所述装置10还包括第二粘结层202，附着在所述第一粘结层201上，所述第一粘结层201粘结在围绕所述凹面29的所述外壳200的底面上。所述第二粘结层202使所述装置10可以附着、取下和重新附着在患者的皮肤上。当首次附着时，所述第二粘结层202粘附在所述皮肤210上。当取下所述装置10时，可以将所述第二粘结层202从所述第一粘结层201上取下，然后使用粘结层201，所述流体输送装置10可以重新附着在所述皮肤210上。
终止于皮肤穿透插管72的针头连接管73示为连接于所述出口组件70。所述针头连接管73是柔性的，使得可以有多种布置，并且可以增强以避免扭折。可以通过选择材料以及壁厚和内径之比获得增强，或者所述管73可以使用内部线圈增强。所述皮肤穿透插管72可以是刚性元件，例如针头，也可以是柔性的。在将所述流体输送装置10附着在皮肤210前，所述皮肤穿透插管72穿过所述皮肤210，并可以使用针头插入辅助机机构插入。这种针头插入辅助机构可以集成到所述流体输送装置10上，或者以独立的机机构提供。图6示出的插管72穿过所述皮肤210的表面进入到皮下组织211。一旦所述流体输送装置10附着在所述皮肤210上，由于在所述装置10和所述皮肤210之间的直接连接，所述针头连接管73保持相对稳定。这种稳定有助于避免所述管73的扭折和因此导致的阻塞，这在其它非固定装置中是经常发生的。
图7示出了所述流体输送装置10的另一示例性实施例，包括给所述局部处理器50提供反馈的传感器，用于多种电子装置的电子组件和可选的第二电源83。例如，所述传感器包括靠近所述容器30的体积传感器222，和靠近所述出口管腔74的阻塞传感器220。
所述微控制器50可以包括微处理器51、内存52、电子时钟振荡器53、模数转换器54和多路复用器55。从图7中还可以看出由用户附着在电池连接器81上的所述可选的第二电源83连接于微控制器50。取下电池盖82装入电池83，向D1方向滑动盖，重新将电池盖82安装在所述流体输送装置10的外壳20上。在优选实施例中，所述电源80仅为存储器维持能力和低功率电子元件提供电力，同时，所述第二电源83为所述装置10的高消耗部件提供电力，例如分配器40。所述电源80和所述第二电源83都可以是消耗电池，例如碱性电池或镍镉电池，或其它的能量储存装置，例如电容器。另外，所述电源80和所述第二电源83都可以是充电式电源。
图8示出了所述流体输送装置10的另一示例性实施例，它包括电子模块300，该模块具有所述局部处理器50和其它模块化子组件的电子装置，这样简化了制造，避免了水或其它流体造成的损坏，屏蔽并防止了电磁干扰和静电。附着在所述电子模块30上并连接于所述通信元件60的是可选的天线61，用于提高通过所述通信元件60从所述流体输送装置10的信号传递。或者，天线61可以集成到电子模块300中。
图8的装置包括警报转换器223，例如蜂鸣器和振动装置，也集成到电子模块300中。所述电子模块300示为包在电子模块外壳301中，电子模块外壳301是所述外壳20的一部分。通过将所有组件封装到填充材料中，所述电子模块外壳301很容易制成防水的，如果不将所述流体输送装置10的所有组件封装到填充材料中，所述电子模块300还可以使用屏蔽材料或涂层抵抗电磁干扰和静电。或者，所述外壳20围绕所述电子模块300的部分可以使用垫衬材料做成屏蔽的或防水的。所述可选天线61，可以包含在所述屏蔽材料外部或内部，示出的是在外部。所述电子模块300可以包括微处理器、逻辑电路、只读存储器、可写存储器、随机访问存储器、模数转换电路、多路复用器、电源80、电阻器、电容器、半导体部件、可编程门电路、运算放大器和多种其它模拟和数字电子部件。
图8a示出了图8所示流体输送装置10的包含在所述外壳20中的透明窗口22，使用户可以可视地观察所述容器30。还示出了一个信息条形码26，其信息可以被遥控装置100的条形码扫描仪读取。所述条形码26的信息可以包括所述容器中的药品数量、类型和浓度，所述装置的生产商和序列号、产品有效期和与哺乳类患者注射的液体药物有关的多种其它信息。
图9示出了所述流体输送装置10的另一示例性实施例，它包括含有柔性铰接部分23的外壳200，使所述流体输送装置10在患者运动时弯曲，避免脱离并有助于患者舒适。所述铰接部分23沿所述外壳20的长度方向延伸，而使所述流体输送装置10可以沿所述铰接部分23的各个轴线弯曲。所述铰接部分23的轴线的方向可以变化，对不同的患者轮廓和布置区域提供最佳适应性。
图9a示出了标准的经由皮肤的注射装置400，包括穿透型插管405，该插管通常为弯折90度的针头、柔性管404和Luer连接器401，连接器包括标准螺纹402。所述注射装置400还可以包括用于附着在患者皮肤上的装置，例如注射装置翼片403，在其底面可以有粘结垫，或可以简单地贴于皮肤上。当使用具有凹进外壳200的流体输送装置10时，可以不需要这种对皮肤的连接。注射装置400可以通过将所述注射装置的Luer连接器401连接于所述装置的出口组件70的Luer连接器71而连接在所述流体输送装置10上。
图10示出了所述流体输送装置10的另一示例性实施例，它包括一个无需使用所述遥控装置100就能够停止流动的装置。在这个实施例中，所述装置包含“T型”止动按钮230，所述止动按钮230穿过所述外壳20伸出，并通过止动按钮弹簧231作用力保持在不工作位置。所述弹簧231位于所述止动按钮230和所述外壳20的部分24之间。在正常状态，流体从所述分配器40排出，通过所述出口管腔74，不受所述止动按钮230的阻碍，排出到所述出口组件70。如图10a所示，当克服所述止动按钮弹簧23 1的作用力压下所述止动按钮230时，所述止动按钮232将所述出口管腔74压紧在所述外壳20的部分25上，直到所述出口管腔74完全阻塞。在所示的实施例中，所述止动按钮230穿过所述外壳20伸出。或者，所述装置可以以如下方式制成，在不工作状态，所述止动按钮230与所述壳体的外表面21平齐，避免流体因不经意地压下所述止动按钮230而引起不必要的阻塞。所述止动按钮230的形状和尺寸可以设计为适应食指，或笔尖。另外，可以添加附加特征，使所述按钮230在按向所述出口管腔74后闭锁并保持。所述锁定特征可以是可逆的，或必须取下而所述流体输送装置10一次性使用。
图11示出了所述流体输送装置10的另一示例性实施例，它包括一种不使用所述遥控装置100传输定量流体的装置。在特定的情况下，在需求时可以投放特定体积和丸剂的流体，而不使用所述遥控装置100。在这里描述了实施例10，其中，用户可以按下机械式丸剂按钮180，释放所需药物丸剂。
从图11a中也可以看出，所述丸剂按钮180呈T型，穿过所述外壳20伸出。通过位于所述丸剂按钮180和所述外壳20内部之间的丸剂按钮弹簧181的力，所述按钮180维持在非启动位置。所述丸剂按钮1 80通过旋转丸剂杠杆187连接在丸剂释放指状件183上。所述丸剂杠杆187具有连接在所述壳体20上的旋转枢轴182，当所述丸剂按钮180向所述弹簧181压下时，所述旋转丸剂杠杆187将所述丸剂释放指状件183从丸剂输送管腔186和所述壳体的丸剂按钮止动部28上移开。所述丸剂输送管186与所述出口管腔74流体连通，因此与所述出口组件70连通。当丸剂按钮180不下压时，来自丸剂按钮弹簧181的偏压使所述丸剂释放指状件183压向丸剂输送管腔186，丸剂输送管腔186压向丸剂按钮止动部28，阻塞所述丸剂输送管腔186。
为了在所述丸剂按钮180下压时能够输送定量的流体，在所述丸剂输送管186中设置了丸剂流动限制器184和丸剂体积储存器185。所述丸剂流动限制器184起用于防止流体从所述容器30中自由流动的流动限制器的作用，并在全丸剂体积之间产生最小的关闭时间。假定在这种特定的实施例中，所述容器30维持在大气压力以上，所述流动限制器184的流速选择为远低于丸剂体积应当输送的速率。
当所述丸剂释放指状件183阻塞了丸剂输送管腔186时，所述丸剂体积储存器185随来自于所述丸剂流动限制器184的流体流入而膨胀。所述丸剂体积储存器185的膨胀量等于将输送的丸剂体积。当所述丸剂按钮180下压时，所述丸剂体积储存器185中维持的流体丸剂体积通过所述丸剂输送管腔186释放到所述出口组件70外。
因为在下游没有流动限制器，分配所述丸剂剂量的时间应较短，并且可以指导用户持续压下所述按钮规定的时间，不超过几秒钟。另一种设计可以仅闭锁所述丸剂按钮180特定的时间，因为必须释放所述按钮，以避免经所述丸剂流动限制器184连续流动。当压下所述丸剂按钮180时，丸剂体积储存器185的流体开始输送，直到丸剂体积储存器185中的压力达到大气压力时为止。释放所述丸剂按钮180使所述旋转丸剂杠杆187反向旋转，沿旋转枢轴182旋转，直到所述丸剂释放指状件183压向壳体的丸剂按钮止动部28，使所述丸剂输送管腔186阻塞。丸剂体积储存器185再次重新膨胀一个等于下一次要输送的丸剂体积的量，流体从容器30流过丸剂流动限制器184，直到丸剂体积储存器185中的压力与容器30中的压力相等。
在图11和11a中，示出的所述丸剂按钮180穿过外壳20突出。或者，在不工作状态，丸剂按钮180可以与所述外壳的外表面21平齐，避免不经意地压下丸剂按钮180造成不需要的丸剂输送。另外，图示出的设计允许丸剂按钮180多次压下，替代设计可以使所述丸剂按钮180一次性工作，需要用户更换流体输送装置10或定位所述遥控装置100。
图12和12a描述了本发明的所述遥控装置100的另一示例性实施例。所述遥控装置100是一个手持装置，包括控制器外壳102，上面装有可视显示器110，例如液晶显示器或LCD。所述可视显示器110可以可视化地显示出编程状态、量、时序，和药液输送的其它参数。其它信息可以包括时刻、住址、应作列表和日历信息，以及可选的娱乐接口，例如计算机游戏。所述可视显示器110的另一用途是显示所接收的信息或将向所述流体输送装置100以外的装置发出的信息，例如糖尿病患者使用的葡萄糖测定仪或其它诊断设备，特别是那些与所述流体输送装置10所输送的注射速率和体积相关的信息。所述遥控装置100可以具有诊断设备，例如血糖监视器或葡萄糖测定仪，或在其上集成可植入的葡萄糖传感器阅读器，通过使患者不必携带和维护两种独立的装置而简化对患者的要求。其它的诊断装置包括但不仅限于血液诊断装置、心电图装置和阅读器、脑电图或EEG装置和阅读器、血压监控器和脉冲血氧定量装置。除了完全集成所述诊断装置外，可以通过无线或硬连线的通信方法执行信息传输。
所述可视显示器110还可以基于所述流体输送装置100的状态包括例如警报和告警状态的信息。例如还可将指示灯、蜂鸣器和振动报警等元件包含在所述遥控装置100内，作为向用户传递信息的备用和冗余手段。
用户可以通过压下安装在控制器外壳102上的多个机电开关获得信息并调整所述装置的程序设定。这些开关可以连接于包含在如图11和11a所示薄膜键盘120的开关排中，这在手持电子装置中是常用的。优选的是，所述薄膜键盘120的机电开关的选择与所述可视显示器110以菜单驱动的方式连接，使得对用户来说从所述装置阅读信息和编程更加友好。在另一实施例中，所述可视显示器110和薄膜键盘120可以合并成一个装置，例如触摸屏显示，这在电子装置中也是常用的。还可以将触摸屏显示、薄膜键盘和单一开关共同集成到所述遥控装置100中。
所述遥控装置100中可以包括多种机电插座，可以接收来自多种装置的机电插头。图中示出了三个插头，条形码阅读器140、葡萄糖测量仪端口150和计算机端口170。通过这些端口可以双向传输信息，增强了遥控装置100的能力，并增进了用户亲密性。图12a示出了所述遥控装置100的剖面示意图。所述薄膜键盘120和可视显示器110连接在所述控制器的电子元件105上。示出的葡萄糖测量仪端口150连接在所述控制器的电子元件105上。条形码阅读器140和计算机端口170也连接在所述控制器的电子元件105上，未示出。所述控制器的电子元件焊装在所述控制器的印刷电路板101上，所述控制器的通信元件160也焊装在所述控制器的印刷电路板101上。
所述控制器的通信元件160用于向所述流体输送装置10的通信元件60发射信号和信息。所述控制器的电子元件105用作“翻译器”，将通过用户接口所接收的用户输入翻译成所述控制器的通信元件160发射的信号。在优选实施例中，所述控制器的通信元件160和所述流体输送装置的通信元件60是双向通信组件，可以在所述遥控装置100和所述流体输送装置10之间双向通信。为了发送无线信息，所述通信元件60和所述控制器的通信元件160可以包括感应线圈或其它发射天线装置。可以使用调频和调幅发送信息，并可以无线电或RF频率范围广播。可使用标准的信息确认技术，例如同步交换或校验求和协议以保证准确的信息传输。使用双向通信，当发现错误时，发射器可以重复发射直至接收，目前通用的双向寻呼技术使用了类似的技术。
如果所述流体输送装置10在患者使用之前预填充，那么局部处理器50的电子存储器可以包含关于流体类型或名称、浓度、数量、体积、溶液中的添加药物和任何稀释剂，但不限于此。这一信息可以从流体输送装置10经其通信元件60传递，经控制器通信元件160上载到遥控装置100。其它的信息液可以在工厂装入流体输送装置10，包括但不限于制造日期、失效日期、消毒日期、比如流动形式确定的治疗信息、甚至病人或医院信息。这一信息可以如上所述上载到遥控装置100中，遥控装置100可以基于接收到的信息调节其内部程序。
在优选实施例中，所述流体输送装置10的电子存储器包括在生产所述流体输送装置10时所述遥控装置100的最新可用程序。类似地，所述遥控装置100的电子存储器包括在生产所述遥控装置100时所述流体输送装置10的最新可用程序。在所述遥控装置100和所述流体输送装置10之间初次通信时，执行校验程序，而且如果可以从另一装置中得到任一装置的新的软件版本，且现有的硬件是兼容的，其它的特征可以程序设定到两个装置中，那么新程序被下载到存储器中，并由升级的装置使用。嵌入程序可以保存在只读存储器，或ROM中，同时，所下载的程序可以写入到电子可擦写存储器中。所述的自动更新特点可用于每一装置以升级另一装置，从而提供了保证用户使用最好的可用产品的另一途径。
与双向通信相关的另一优点是添加了接近性报警。所述流体输送装置10和所述遥控装置100电子仪器可以这样设计，当两个装置之间的距离大于特定的径向距离时，其中之一或两个装置将使用音频报警提醒用户。所述报警距离可以选择为低于两个装置的最大通信距离。一种产生警报的方法是，所述流体输送装置10以事先确定的速率、以低于正常通信功率的功率或振幅频繁发送信息包，为所述的接近性检测提供安全裕度。所述遥控装置100程序设定为期望以事先确定的速率接收这种通信，并且一旦接收不到一个或多个这种信息包引发所述遥控装置100启动音频报警器106。或者或此外，可以含有振动警报器。通过在所述流体输送装置10的外壳20中集成一种装置例如磁铁、并在所述遥控装置100中集成磁场检测装置，接近性警报可以包括但不要求双向通信。当所述遥控装置100的磁场检测装置没有检测到所述流体输送装置10的磁场存在时，所述遥控装置100启动所述控制器的音频报警器106。
所述遥控装置100包括控制器电源108，为包括所述控制器电子元件105、控制器音频报警器106在内的多种电子元件供电。所述控制器电源108可以是标准电池，在优选实施例中，所述控制器电源108可以由用户移开电池盖(未示出)，插入并连接电源108进行更换。在另一实施例中，所述电源集成到所述遥控装置100中，可以由单独的装置充电，或包含由足够的电力，以在预期的使用时间内为所述装置供电。
本发明的所述流体输送装置10可以销售到医院、药房、门诊中心或患者本人。如果所述流体输送装置意欲短期使用或一次性使用，可以在销售每个装置时带有多种附件或附件组方便用户。将所述流体输送装置的某些零件、或附件例如类似上述的可连接的经由皮肤的注射装置，希望消毒包装在保护性包装中。适当地对接收所述经由皮肤通路的工具的皮肤部分进行无菌维护对防止感染非常重要。图13，13a，13b和13c描述了可以成套包装在一起的多种部件。
图13示出了本发明中的所述流体输送装置，包括用于观察所述容器30状态的装置和信息条形码26，其中在消毒组件包350中有消毒装置。所述装置可以分别包装，或与其它多种成套部件包装在一起。为了消毒并维持无菌化，所述流体输送装置可以整体无菌包装在装置袋351中。这种袋经常使用例如杜邦生产的高密度聚乙烯合成纸TYVEK制成。消毒组件包350包括本发明的流体输送装置10，如图13所示密封在装置袋351中。或者，可以对所述流体输送装置围绕所述出口组件70的部分使用消毒保护罩覆盖、封装并消毒。
所述外壳20的顶部，或外壳顶面203包括在所述容器30之上的外壳透明窗22。所述外壳透明窗22的透明性和所述容器30的设计使患者可以透过所述外壳透明窗22观察，确定关于所述容器30的状态信息。这种信息包括剩余药品的量，或是否出现泄漏。或者，整个所述外壳20可以是透明的，以产生类似视觉效果。
在本实施例中所述流体输送装置还包括信息条形码26，它包括关于特定流体输送装置10的多条信息，例如类型、体积和所述装置中预填充的药物浓度、装置或药物的有效期、装置或药物的生产日期、序列号、批号、医院名称、临床医生姓名、患者姓名、药物使用要求和其它信息。所述条形码信息可以读入到医院或家庭的计算机中，或在所述优选实施例中，通过条形码阅读器下载到所述遥控装置100中。所述流体输送装置10和所述遥控装置100的电子元件和程序可以这样设计，即必须在程序设定或使用所述流体输送装置10前读出所述条形码信息。这一特点可以大大降低例如与患者输入药品信息相关的程序错误。如果患者输入了不正确的药品浓度，则所有剩余程序中的药品单位都不正确，而不是体积，这种情况是经常发生的，尽管所述装置能够正常工作，基于输入的不正确的浓度与所输送药品真实浓度的比，输送的所有体积都是不正确的。很多药物可以有多种浓度，例如用于患者的胰岛素经常做成浓度为40、50和100单位/毫升。
图13a示出了本发明的所述遥控装置100可以与一个或多个消毒组件包350成套包装或提供，包括至少一个流体输送装置10。没有必要对所述遥控装置100进行消毒操作，因此如果所述流体输送装置10已经消毒，可以将一个或多个消毒组件包350、单个遥控装置100连同一个和多个其它装置10一起装入盒中或其它包装中。
图13b示出了治疗流体源250，它可以包括小瓶药品，例如胰岛素。经过消毒或适应的生物兼容性操作以便使用、并装在一个或多个小瓶中的所述药品可以和一个或多个消毒组件包350以及一个或多个遥控装置100一起包装。如果需要，套件中还可以包括其它装置。
图13c示出了消毒的注射装置组件407，它包括上述经由皮肤的注射装置400，包装在注射装置袋406中。所述注射装置400包括连接于注射装置柔性管404上的Luer注射装置401，Luer注射装置401终止于注射装置穿透插管405。可以包括可选的注射装置翼片403，以将所述注射装置400附着在患者的皮肤上。在优选实施例的所述流体输送装置100中，所述经由皮肤的输送装置可以集成到所述出口组件70中，然而，在另一实施例中，所述出口组件70可以连接在所述注射装置400上。在这一特定的实施例中，将消毒的注射装置组件407与任意数量的一个和多个消毒的组件包350、所述流体输送装置10、所述遥控装置100或治疗流体源250成套配给是优选的。
本发明的所述流体输送装置10是用于降低成本并可以一次性使用。因为每两到五天更换所述装置非常有利，所以也会产生相当数量的废弃物，如果一个或多个部件可以生物降解则是有利的。所述流体输送装置10可以包括预先安装的电池作为其电源80。为了避免电池在使用前向所述流体输送装置10的电子元件供电，可以包括一个机械开关，在使用所述遥控装置100开始编程之前，将所述电池的触点连接于所述电子元件。一种简化的开关设计可以是在所述电源80的电池触点和所述局部处理器50的电连接之间的绝缘材料。所述绝缘材料应设计为突出到外壳20外，可以由用户去除，未示出。用户可以拉出所述绝缘材料并去除，同时将所述电源80的电池触点和所述局部处理器50的电连接接通。
本发明的所述流体输送装置10可以由设备生产商、药剂公司和其它生产商在装运到达医院、药房或患者前填充治疗流体。某些需要冷冻或其它特殊环境条件的药品，需要冷冻预填充的流体输送装置、或其它处理以满足特殊需求。如果长期储存，胰岛素是一种需要冷冻的药品。德国Frankfurt的Hoechst正在开发一种在较高温度下稳定的胰岛素。在常温下稳定的药物诸如Hoechst开发的胰岛素简化所述流体输送装置10的填充和处理，从而大大简化了对患者的要求。
在本发明和上述说明中包括多种使用所述流体输送装置10的方法。并且描述了使用所述遥控装置100程序设定所述流体输送装置10的方法，以及包括经由皮肤的注射装置和例如葡萄糖测量仪的诊断装置在内的外围设备的连接和使用。还涉及使用相应的装置更新所述流体输送装置10或所述遥控装置100的内部程序。还说明了在生产过程中或由用户向所述流体输送装置10中添加治疗流体的方法。还描述了消毒和包装所述流体输送装置10的一部分或全部以及治疗流体的方法和时序。
尽管已经示出并描述了本发明的示例性实施例，但对于本领域的技术人员来说，可以作出变化、修改和置换，而不背离本发明的主旨和范围。例如，本发明的流体输送装置通过从流体输送装置中去除了包括机电开关的大部分用户接口并含有单独的控制器代替这些功能，意欲低成本、重量轻、易于使用且可以一次性使用。在所述流体输送装置中包括容器、流体分配器、经由皮肤的流体管路装置、固态电子元件和无线通信元件执行预期的功能。在本申请中已经讨论了多种形式的容器构造、压力装置、流体泵送装置、流体测量装置、经由皮肤的输送、电子控制和无线通信，对这些领域的修改不脱离本发明的主旨。
另外，本发明的申请中以特定顺序列出了方法步骤和程序，但可以改变某些步骤的执行顺序(在某些特定的情况下甚至颠倒)。在下述权利要求书中，除非在权利要求书中说明了顺序的特殊性，方法的特定步骤或程序不构成特定顺序。

Claims (51)

1.一种用于向患者输送流体的装置，包括：
适于连接在经由皮肤的患者进入工具上的出口组件；
用于使流体从容器流到所述出口组件的分配器；
连接于所述分配器、并可被编程而基于流动指令使流体流到所述出口组件的局部处理器；
连接于所述局部处理器、用于从独立的遥控装置接收流动指令并将流动指令输送到所述局部处理器的无线接收器；以及
容纳所述出口组件、分配器、局部处理器和无线接收器的外壳；
其中，所述外壳没有用于向所述局部处理器提供流动指令的用户输入部件。
2.如权利要求1所述的装置，其特征在于，所述的流动指令使流体在预定的时间周期以预定速率流动。
3.如权利要求2所述的装置，其特征在于，所述流体的预定流动速率包括基本速率。
4.如权利要求1所述的装置，其特征在于，所述流动指令使预定体积的流体流动预定时间。
5.如权利要求4所述的装置，其特征在于，所述预定体积包括丸剂体积。
6.如权利要求1所述的装置，其特征在于，所述局部处理器被编程以导致包含脉冲体积的流体流动。
7.如权利要求1所述的装置，其特征在于，还包括至少一个用户接口部件，可以从所述壳体的外部操作，用于阻塞向着所述出口组件的流动。
8.如权利要求1所述的装置，其特征在于，还包括用于向所述局部处理器供应电能的电源。
9.如权利要求8所述的装置，其特征在于，所述电源集成到所述装置中。
10.如权利要求8所述的装置，其特征在于，所述电源包括可更换的电池。
11.如权利要求1所述的装置，其特征在于，所述接收器使用无线电频率信号。
12.如权利要求1所述的装置，其特征在于，还包括连接于所述局部处理器的发射器，用于从所述局部处理器向独立的遥控装置发射信息。
13.如权利要求12所述的装置，其特征在于，所述外壳没有用于从所述局部处理器提供信息的用户输出部件。
14.如权利要求1所述的装置，其特征在于，所述出口组件包括Luer连接器。
15.如权利要求1所述的装置，其特征在于，还包括连接于所述出口组件的经由皮肤的患者进入工具。
16.如权利要求15所述的装置，其特征在于，所述经由皮肤的患者进入工具包括管状元件。
17.如权利要求16所述的装置，其特征在于，所述管状元件用于停留在患者的皮下组织中。
18.如权利要求17所述的装置，其特征在于，所述管状元件包括刚性的针头。
19.如权利要求15所述的装置，其特征在于，所述经由皮肤的患者进入工具包括微型穿透器。
20.如权利要求1所述的装置，其特征在于，还包括容器，并且所述分配器控制流体从所述容器向所述出口组件的流动。
21.如权利要求20所述的装置，其特征在于，所述容器包含治疗流体。
22.如权利要求20所述的装置，其特征在于，还包括连接于所述容器的填充端口。
23.如权利要求20所述的装置，其特征在于，所述容器由柔性材料制成，且排空时收缩。
24.如权利要求20所述的装置，其特征在于，所述容器是绝热的。
25.如权利要求20所述的装置，其特征在于，所述容器被加压。
26.如权利要求25所述的装置，其特征在于，还包括压缩所述容器的弹簧。
27.如权利要求20所述的装置，其特征在于，还包括连接于所述出口组件的第二容器。
28.如权利要求20所述的装置，其特征在于，还包括：
连接于所述容器的可膨胀的丸剂存储器；以及
至少一个用户接口部件，可以从所述壳体的外部操作，用于打开所述丸剂存储器和所述出口组件之间的流体流动。
29.如权利要求1所述的装置，其特征在于，所述分配器包括可膨胀的存储器、控制从容器进入到所述存储器流动的入口阀、和控制所述丸剂存储器和所述出口组件之间流动的出口阀。
30.如权利要求1所述的装置，其特征在于，所述分配器包括泵，用于从容器向所述出口组件泵送流体。
31.如权利要求1所述的装置，其特征在于，还包括连接于所述局部处理器的至少一个传感器，并且包括至少一个阻塞检测器、容器体积转换器、容器排空检测器、泄漏检测器、压力转换器、流体接触检测器、阻抗检测器、电压检测器、光电检测器和振动监视器。
32.如权利要求1所述的装置，其特征在于，还包括连接于所述局部处理器的报警器。
33.如权利要求1所述的装置，其特征在于，还包括位于所述外壳外部的粘结剂。
34.如权利要求33所述的装置，其特征在于，所述粘结剂设置在围绕所述出口组件的至少一条连续带上。
35.如权利要求1所述的装置，其特征在于，所述出口组件安装于所述外壳的凹陷部分中。
36.如权利要求1所述的装置，其特征在于，所述外壳是柔性的。
37.如权利要求36所述的装置，其特征在于，所述外壳包括铰接部分。
38.如权利要求1所述的装置，其特征在于，所述外壳包括窗口。
39.如权利要求1所述的装置，其特征在于，所述外壳包括通风孔。
40.如权利要求1所述的装置，其特征在于，所述局部处理器和所述接收器封装在电磁屏蔽材料中。
41.如权利要求40所述的装置，其特征在于，所述接收器包括伸出到所述电磁屏蔽材料外的天线。
42.如权利要求1所述的装置，其特征在于，所述局部处理器包括可以被遥控装置更新的程序。
43.一种系统，包括如权利要求1所述的流体输送装置、以及一种独立于所述流体输送装置的遥控装置，还包括：
远程处理器；
连接于所述远程处理器的用户接口部件，可以使用户向所述远程处理器提供流动指令；以及
连接于所述远程处理器的发射器，用于向所述流体输送装置的接收器发射流动指令。
44.如权利要求43所述的系统，其特征在于，还包括接近性报警器。
45.一种包括如权利要求43所述的系统的套件，其特征在于还包括用于连接于所述流体输送装置的出口组件的皮下患者进入工具。
46.一种如权利要求45所述的套件，其特征在于，包括单个遥控装置和多个流体输送装置。
47.如权利要求46所述的套件，其特征在于，每个流体输送装置都包括条形码，并且所述遥控装置包括条形码扫描器。
48.一种用于向患者输送流体的装置，包括：
适于连接在经由皮肤的患者进入工具上的出口组件；
用于使流体从容器流到所述出口组件的分配器；
连接于所述分配器、并可被编程而基于流动指令使流体流到所述出口组件的局部处理器，所述局部处理器还可被编程以提供流动信息；
连接于所述局部处理器、用于从所述局部处理器向独立的遥控装置发射流动信息的无线发射器；
容纳所述出口组件、分配器、局部处理器和无线发射器的外壳；
其中，所述外壳没有用于从所述局部处理器向用户提供流动信息的用户输出部件。
49.如权利要求48所述的装置，其特征在于，所述局部处理器被编程以从单独的遥控装置接收至少部分流动指令，并且所述装置还包括连接于所述局部处理器的无线接收器，用于从单独的遥控装置接收流动指令，并将所述流动指令输送到所述局部处理器。
50.一种系统，包括如权利要求48所述的流体输送装置、以及独立于所述流体输送装置的遥控装置，还包括：
远程处理器；
连接于所述远程处理器的用户输出部件，可以使用户接收流动信息；以及
连接于所述远程处理器的接收器，用于从所述流体输送装置的发射器接收所述流动信息。
51.一种用于向患者输送流体的系统，包括：
a)流体输送装置，可以附着在患者的皮肤表面，包括：
适于连接在经由皮肤的患者进入工具上的出口组件；
用于使流体从容器流到所述出口组件的分配器；
连接于所述分配器、并可被编程而至少部分地基于接收到的流动指令使流体流到所述出口组件的局部处理器，且所述局部处理器还可被编程以提供流动信息；
连接于所述局部处理器、用于接收流动指令并将流动指令输送到所述局部处理器的无线接收器；
连接于所述局部处理器、用于从局部处理器发射流动信息的无线发射器；以及
容纳所述出口组件、分配器、局部处理器、无线接收器和无线发射器的外壳；
其中，所述外壳没有用于向所述局部处理器提供流动指令的用户输入部件；以及
b)独立于所述流体输送装置的遥控装置，并包括：
用于接收用户输入的用户输入部件；
用于提供用户输出的用户输出部件；
连接于所述用户输入部件、并可被编程以基于用户输入提供流动指令的远程处理器，并且所述的远程处理器连接于所述用户输出部件，以基于所述流动信息提供用户输出；
连接于所述远程处理器的无线发射器，用于向所述流体输送装置的接收器发射流动指令；以及
连接于所述远程处理器的无线接收器，用于从所述流体输送装置的发射器接收流动信息。
CNA018181600A 2000-09-08 2001-08-31 用于患者注射的装置、系统和方法 Pending CN1471413A (zh)

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WO2002020073A2 (en) 2002-03-14
WO2002020073A3 (en) 2002-06-27
US20040087894A1 (en) 2004-05-06
US7029455B2 (en) 2006-04-18
US6740059B2 (en) 2004-05-25
CA2771723C (en) 2016-03-29
DE60128826T2 (de) 2008-02-07
AU8857501A (en) 2002-03-22
US20020072733A1 (en) 2002-06-13
DK1335764T3 (da) 2007-10-01
US20050171512A1 (en) 2005-08-04
EP1335764A2 (en) 2003-08-20
ATE363922T1 (de) 2007-06-15
CA2771723A1 (en) 2002-03-14
CA2421133A1 (en) 2002-03-14
US7137964B2 (en) 2006-11-21
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CA2421133C (en) 2012-06-26
AU2001288575B2 (en) 2006-06-01

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