CN101185042B - 具有自动校准功能的流体输送装置 - Google Patents

具有自动校准功能的流体输送装置 Download PDF

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CN101185042B
CN101185042B CN2006800180737A CN200680018073A CN101185042B CN 101185042 B CN101185042 B CN 101185042B CN 2006800180737 A CN2006800180737 A CN 2006800180737A CN 200680018073 A CN200680018073 A CN 200680018073A CN 101185042 B CN101185042 B CN 101185042B
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pump
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CN101185042A (zh
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本杰明·M·拉什
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Therasense Inc
Abbott Diabetes Care Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14212—Pumping with an aspiration and an expulsion action
    • A61M5/14216—Reciprocating piston type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
    • F04B43/00—Machines, pumps, or pumping installations having flexible working members
    • F04B43/02—Machines, pumps, or pumping installations having flexible working members having plate-like flexible members, e.g. diaphragms
    • F04B43/04—Pumps having electric drive
    • F04B43/043—Micropumps
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
    • F04B49/00—Control, e.g. of pump delivery, or pump pressure of, or safety measures for, machines, pumps, or pumping installations, not otherwise provided for, or of interest apart from, groups F04B1/00 - F04B47/00
    • F04B49/06—Control using electricity
    • F04B49/065—Control using electricity and making use of computers
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
    • F04B51/00—Testing machines, pumps, or pumping installations
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01F—MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F1/00—Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow
    • G01F1/704—Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow using marked regions or existing inhomogeneities within the fluid stream, e.g. statistically occurring variations in a fluid parameter
    • G01F1/708—Measuring the time taken to traverse a fixed distance
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01F—MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F11/00—Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it
    • G01F11/02—Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it with measuring chambers which expand or contract during measurement
    • G01F11/021—Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it with measuring chambers which expand or contract during measurement of the piston type
    • G01F11/029—Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it with measuring chambers which expand or contract during measurement of the piston type provided with electric controlling means
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01F—MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F25/00—Testing or calibration of apparatus for measuring volume, volume flow or liquid level or for metering by volume
    • G01F25/0084—Testing or calibration of apparatus for measuring volume, volume flow or liquid level or for metering by volume for measuring volume
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01F—MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F25/00—Testing or calibration of apparatus for measuring volume, volume flow or liquid level or for metering by volume
    • G01F25/10—Testing or calibration of apparatus for measuring volume, volume flow or liquid level or for metering by volume of flowmeters
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05D—SYSTEMS FOR CONTROLLING OR REGULATING NON-ELECTRIC VARIABLES
    • G05D7/00—Control of flow
    • G05D7/06—Control of flow characterised by the use of electric means
    • G05D7/0617—Control of flow characterised by the use of electric means specially adapted for fluid materials
    • G05D7/0629—Control of flow characterised by the use of electric means specially adapted for fluid materials characterised by the type of regulator means
    • G05D7/0694—Control of flow characterised by the use of electric means specially adapted for fluid materials characterised by the type of regulator means by action on throttling means or flow sources of very small size, e.g. microfluidics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0272—Electro-active or magneto-active materials
    • A61M2205/0288—Electro-rheological or magneto-rheological materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/70—General characteristics of the apparatus with testing or calibration facilities
    • A61M2205/702—General characteristics of the apparatus with testing or calibration facilities automatically during use
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
    • F04B2205/00—Fluid parameters
    • F04B2205/09—Flow through the pump
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F05—INDEXING SCHEMES RELATING TO ENGINES OR PUMPS IN VARIOUS SUBCLASSES OF CLASSES F01-F04
    • F05C—INDEXING SCHEME RELATING TO MATERIALS, MATERIAL PROPERTIES OR MATERIAL CHARACTERISTICS FOR MACHINES, ENGINES OR PUMPS OTHER THAN NON-POSITIVE-DISPLACEMENT MACHINES OR ENGINES
    • F05C2251/00—Material properties
    • F05C2251/08—Shape memory

Abstract

微型流体输送装置在医疗领域十分有用。该装置可由使用者佩戴或携带，并可以将药剂或是其他药物输送给使用者或是患者。此装置具有控制系统，该控制系统接收来自使用者的输入，并且控制装置运行的所有方面。控制系统测量泵的输出，并对泵的输出进行调节以达到期望的剂量速率和大小。这消除了泵与泵之间的差异，这种差异来自制造这种消费得起的小型装置过程中不可避免的偏差。

Description

具有自动校准功能的流体输送装置
技术领域
本发明通常涉及诸如泵的流体输送装置，并且更具体地涉及小型泵的控制与使用。
背景技术
尽管本发明可以用于多种不同类型和尺寸的泵，但本发明对于小型或微型一次性(disposable)泵尤其有用。此种泵的一个应用就是输送胰岛素。
一种小型或微型泵使用活塞推动一定体积的液体，该液体体积由活塞体积(内径×行程)和伴随隔膜(diaphragm)的体积确定。液体、例如胰岛素的剂量为讨论的目的假设与在活塞的一个输送行程中排出的液体的体积相等。
小型泵的一个特征是活塞隔膜组件要求极高的制造公差，以便形成从一个泵到另一个泵可重现的剂量体积。例如，具有通常尺寸的小型活塞型泵，当行程长度每变化1/10000英寸时其剂量体积就会变化0.5％。行程长度由三个分离部件的直线尺寸确定：活塞、缸和隔膜，其中的每一个均具有10/10000英寸以上的公差。当每个部件的最大偏差同时到达时，会导致剂量体积偏离标称值±15％。结合隔膜直径和活塞头直径的额外偏差进一步增强了这一问题。
如果此种泵的一些应用包括药剂输送，那么输送泵与泵之间相同的剂量体积是很重要的。这在一次性泵的情况下(泵规律地被另一个相同类型的泵替换)尤其恰当。不考虑泵的应用，所期望的是补偿制造公差并且制造具有精确剂量输送的可重复泵。
发明内容
本发明提供了一种简单、经济且可靠的用于确定由给定泵产生的剂量大小的机构和方法，它们随后被用于校准泵，从而在泵的容积方面的制造偏差标准化。这使得从给定设计的一个泵到另一个泵的流体输送更可靠并更具重复性。
本发明的另一方面包括测量泵的剂量体积，优选地在初始的起动程序期间进行，或可选地在随后的任何时间进行。该体积随后被用于校准剂量周期的定时。例如，如果具体泵的实际测量的体积被确定为比基准值(如期望的体积标称值)大15％，，那么全部后续输送速率的定时都因此而减小。测量可作为制造程序的一部分进行或可由使用者作为泵初始化程序的一部分进行。测量还可以在泵运行过程中的任何时间由泵自动进行。泵输送的校准或调整优选在使用泵之前由使用者进行，但是也可以在泵的使用寿命期间的任何时间进行。
另一方面包括利用便携式分配装置将液体分配给使用者的方法。此方法包括：泵送液体；在第一传感器处检测液体的到达；在第二传感器处检测液体的到达；测量液体从第一传感器到达第二传感器的时间间隔；计算分配装置的体积流速；以及调整装置的分配的体积流速。
再一方面，包括用使用者佩戴或携带的装置将含有药剂的液体向使用者给药的方法。此方法包括：提供包括泵元件的一次性部件；提供包括微处理器的耐用部件，其中一次性部件被构造成与耐用部件配合并由其操作；启动液体流(含有多个剂量)使之通过具有已知容积的装置的一部分；确定泵送已知容积需要的时间；以及确定剂量的体积。
本发明的其它方面、优点和特征包括在随后结合附图的对本发明示例性实例进行的描述中，并且在整个附图中使用相同(和相似)的标号来描述相同特征。为了所有目的，文中提及的所有的专利、专利申请、文章、以及其它公开出版物整体结合于此作为参考。
附图说明
图1A是本发明实施例的运行的流程图。
图1B是图1A中提及的本发明实施例的示意图。
图2A示出了泵200，即可用本发明的一种泵的实施例，示出其处于第一状态。
图2B示出了泵200，即可用于本发明的一种泵的实施例，示出其处于第二状态。
图2C是示出用于泵200的驱动电路的实例的示意图。
图3是描述根据本发明一个实施例的运行的流程图。
图4是根据本发明实施例的运行的流程图。
图5是根据本发明实施例的运行的流程图。
具体实施方式
消除一个泵与(具有相同设计的)另一个泵之间的偏差是十分重要的，这种偏差是制造局限性的结果。本发明可用来使这些偏差的影响最小化并在任何类型的液体泵中实现精确输送。
如在背景技术中讨论的，有一种类型的液体泵，即小型活塞型泵，本发明对其特别有利。小型泵的活塞隔膜组件要求极高的制造公差，以便形成从一个泵到另一个泵的可再现的剂量体积。即使以高精度制造，从给定设计的一个泵到另一个泵也可能出现不可忽略的偏差。这是不理想的，特别是在涉及药物输送或其他医疗应用的泵的应用中。
本发明提供了一种简单、经济且可靠的机构和方法，用来使泵与泵的差别最小化或是“为零”。一个方面涉及逻辑或处理器控制的程序，其可设想作为装置的自动校准。在最普遍的意义中，这包括：测量由给定泵产生的剂量体积；将该剂量与那种特定类型的泵设计所期望的标称剂量体积进行比较；以及随之据此调整泵的输出。这还可通过测量流速并随之据此进行相应调整来实现。体积和流速的测量都包括使用一个或多个指示出液体在一个或多个给定点存在的传感器。尽管有多种方法调节泵的输出，但进行调节的优选方法是计算测量的体积与期望的体积之间的比值并根据该比值来校准输送。
尽管本发明可在任何环境中用于输送任何液体，但在本发明尤其适合的医疗环境中，可输送的液体类型包括(但不限于此)：胰岛素、抗生素、麻醉剂、营养液、止痛剂、激素或相关药物、基因治疗药物、抗凝血剂、心血管药物、HIV治疗药物、癌症治疗药物等。这些药物可通过皮肤上的一种贴片(patch)经由皮肤输送，或者液体可以被蒸发或吸入。本发明不限于输送这些液体或通过该措施进入患者的身体系统，这些仅仅是实例，而非全部列表。
另外，本发明尤其有用的一种应用是输送胰岛素。具体地，它在通过已知的小型或微型泵规律地输送少量的胰岛素时很有用。顾名思义，小型或微型泵的输送量相对较少。在所述针对胰岛素输送的优选实施例中，这种微型或小型泵的每一次动作或剂量均在约0.5到5.0微升的范围内，每天的可能输送总量约1000微升。其他液体(在医药领域中)的输送量可以高达每天约5000微升或是5cc。
图1A是描述根据图1B的示意图中看到的本发明实施例的运行的流程图。图1A中示出的程序可在任何时间进行。它还可以与泵的充注(起动)一起进行。在图1B中有两个传感器，上游传感器144和下游传感器146，两个传感器之间的容积已知。在此实施例中的已知容积(或校准区域154)具有圆柱形状，但只要该容积已知或是可以被确定，任何几何(规则或不规则)形状都可被采用。校准区域的几何形状应该能够使该校准区域以足够高的可重复性被加工，并且校准区域的容积优选远大于胰岛素溶液单次剂量的体积。这在测量中确保了良好的分辨率和准确度。传感器连接于控制单元150，控制单元又连于泵200。控制单元150包括驱动电路250和逻辑单元152，该逻辑单元优选地采用微处理器的形式。每个传感器均包括一对导电电极，并且当电流在这对电极之间通过时，它通过在这对电极之间建立电连续性来指示出液体的存在。只要液体具有某种程度的电连续性，就能够测量出液体的存在。如在现有技术中应了解的，电极的材料可以适合特殊的应用场合。在胰岛素的情况下，金电极工作良好。如前面提及的，泵200可以是任何类型的液体泵。在成本为重要因素的应用中，经常优选使用由形状记忆致动器(shape memory actuator)驱动的泵。在医疗领域中的情况下尤其是这样，在该领域中由于各种原因装置会相对频繁地被丢弃或是更换。
控制单元150通常控制泵200和流体输送装置的运行，该控制单元还可包括用户界面(未示出)，用于设定各种运行参数(如输送速率)并且用于启动和停止装置。控制单元还起动并控制装置的校准。有关该装置的结构和运行的更多信息，请参考2003年10月9日提交的美国申请No.10/683,659，其公开为美国专利申请公开No.2004/0115067 A1，其全部内容结合于此作为参考。
回到图1A的流程，在步骤105中控制单元起动液体流。接着，在步骤110中，控制单元在A点(第一点)检测液体的到达。该点对应于图1B中的上游传感器144。当液体首次行进时或者在液体到达上游传感器144之前在流动流中置入障碍物，通过这两种方式均可以进行检测。例如，干扰流体的一种方式是向流动流中注入气泡。在步骤120中，控制单元在B点检测行进液体的到达，该点对应于图1B中的下游传感器146。对于直径已知的圆柱形校准区域154，如果两个传感器之间的距离已知，则区域的容积就可知。
在步骤130中，控制单元150测量液体从A点流到B点所需要的时间。在步骤135中还根据测量的时间和两点间的已知容积计算体积流速(volumetric flow)。随后用此信息调节泵的输送，如在步骤140中所示。此程序可在任何时间进行。它可以在最初用来校准泵，或是在装置运行过程中的任何时间进行。即使未向流体中插入不连续中断，传感器也可指示出该装置的流速(flow rate)。由电极产生的信号会随着液体传导速率的增加而增大。因此，如果液体被均匀混合，则信号将随流速的增加而增加。对于给定的电极/液体组合，可以针对给定浓度确定输出与流速比值的曲线分布。控制器此时可参考这个存储在存储器中的数据来确定流速。关于此情况的更多信息，请参考Benjamin M.Rush的名称为“Devices And MethodsFor Use in Assessing a Flow Condition of a Fluid in a Flow Path”的美国相关未授权申请No.--/---，---，其全部内容结合于此作为参考。
图2A和2B示出了泵200，它是特别适用于本发明的一种泵的实施例。此泵由形状记忆元件206驱动，并采用包括来自开关209、开关210和线性反馈系统211的反馈，所有这些都指出了活塞204的位置。
图2A中示出未启动(inactive)状态下的泵200，图1B示出它的工作状态。开关209指示活塞或者泵在打开位置，并且开关210指示活塞或者泵在关闭位置。泵主体包括壳体201、顶盖202和活塞盖203。泵内是活塞204，其通常(在未启动状态下)通过活塞偏压弹簧205保持抵靠在活塞盖203上。活塞204连接到形状记忆元件206上，当通过电流的一个或多个脉冲被加热时该形状记忆元件收缩，该电流从V+207触点经由形状记忆元件206流到V-208触点(这里V-208触点可以是系统接地参考)。每个脉冲中的能量由通过触点施加到形状记忆元件上的电压确定。值得注意地是，壳体由绝缘材料制成，而活塞或者由导电材料(例如金属)制成或者涂覆有适当导电性的材料。
图2A示出了未启动状态下的泵，此时形状记忆元件206没有收缩，并且活塞204通过活塞偏压弹簧205保持抵靠在活塞盖203上。这是泵在每次启动或泵送周期后返回的状态。
图2B示出在工作状态中的泵，此时形状记忆元件206已充分收缩而拉动活塞204向上抵靠在构置于壳体201内的止挡部上。
图2C示出了驱动电路250，即可用于泵200的电路的实施例。驱动电路250包括到达/来自逻辑单元152的输入和反馈，该逻辑单元优选包括微处理器，如前提及的。关于形状记忆致动泵的这方面和其他方面的更多信息，请参考Christopher V.Reggiardo等人的名称为“Variable Volume，Shape Memory Actuated Insulin DispensingPumping”的美国相关未授权申请No.--/---,---，其全部内容结合于此作为参考。
图3是描述根据本发明一个实施例的运行的流程图。如较早所讨论的，在步骤310中控制单元测量流速。接下来在步骤320中，系统确定所期望的剂量体积。这可以自动进行或是由使用者输入。在步骤330中，系统基于测得的流速确定校准因数。校准因数优选包括期望剂量体积和实际剂量体积的比值。在较前描述的活塞型泵的情况中，校准因数包括缸的标称容积与缸的实际容积的比值。标称容积可以是设计规范期望的容积值，也可以是基于产品样品的大样本的期望标称值。一旦将它确定，就在步骤340中应用校准因数并在后续的系统运行中应用，包括在步骤350中输送期望的剂量时。
图4是描述根据本发明另一实施例的运行的流程图。在步骤410中，确定在一次泵行程中输送的体积。在步骤420中，系统确定期望的剂量体积，其可自动进行或是由使用者输入。接下来在步骤430中系统确定与期望剂量体积相对应的所需要的行程的次数。由于本发明的线性反馈，系统可输送行程的部分，并且行程的次数可包括任意次数的部分行程。接着，在步骤440中，系统通过使活塞运动适当次数的行程来输送期望的剂量体积。
图5是描述使用系统的两个实施例的流程图。一个实施例包括两个单元：一次性单元和可重复使用单元，而另一个实施例将全部部件结合到一个一次性单元中。图1B中所示的系统的一些或所有部分是可重复使用的，但是在存在可重复使用部件的情况下，它包括控制单元150。术语“一次性”是指这个词通常的意思，是指在数天到数月的数量级内预计使用。术语“可重复使用”也是指通常的意思，描述耐用部件在数月到数年的数量级内预计使用。
在步骤510中，使用者打开一次性部件，该一次性部件在其贮存器内具有已选定的液体或药剂。接下来，在步骤520中，使用者将一次性部件与可重复使用部件配合到一起。
可选地，在步骤525中，使用者可简单地打开系统(在贮存器中预填充有液体)，该系统整体都是一次性的。
在步骤510中，使用者打开一次性部件，该一次性部件在其贮存器内具有已选定的液体或药剂。接下来，在步骤520中，使用者将一次性部件与可重复使用部件配合到一起。
可选地，在步骤525中，使用者可简单地打开系统(在贮存器中预填充有液体)，该系统整体都是一次性的。
此后，在步骤530中控制器启动泵的注入和校准。在步骤540中，泵随后从贮存器中驱动液体以流过泵的内部容积，包括通过校准区域154。接着在步骤550中，确定诸如校准因数的校准参数。此后，在步骤560中，控制器根据校准参数修改随后的泵的定时。例如，如果校准参数指示出测得的具体泵的容积小于期望的产品单元的标称容积，则输送剂量的频次(frequency)将增加。在步骤570中，使用者安装一次性组成部分(包括在一个实施例中的控制器)并通过控制器用户界面设定期望的输送速率。步骤560可以在步骤570之前或之后发生，并且除非有明确地说明否则这两个步骤没有特定顺序。
实验结果
本发明的实施例在三个试验中进行测试。剂量体积通过实施例来确定，并且与剂量体积的重量测定的进行比较。结果证实了由实施例进行的测量的准确性。三次测量结果如下所示。
本发明校准装置的功能模块由外径为0.125英寸且内径为0.0625英寸的一段管构成。传感器是成对的铜线并且测定给定对中的两铜线间的电连续性作为胰岛素对铜线的浸润的指示。在每个传感器电极对之间施加小电压。在行进的胰岛素的前沿与任一个传感器电极对相接触的位置处形成回路，从而使电流通过回路。通过监控设置在每个传感器回路中的电流感应电阻器上的电压来检测电流。利用定时装置监控行进的胰岛素前沿穿过两个传感器之间的距离所需要的时间。
如可从下面看到的，三次试验测量值相差不超过1％，并且与两次重量测定测量值相差不超过1％。两次重量测定的测量值相差不超过2％。针对功能模块进行的测量值约为两次重量测定的测量值的平均数。这证实了本发明的准确性。
测试校准区域
ID：            1.588mm(0.0625″)
横截面面积：    1.979mm2
电极间隔：      76.20mm(3.00″)
容积：          150.80mm3
试验1：
剂量周期：      14.92秒
通过电极的时间：1003秒
通过电极的剂量：67(四舍五入为整数)
剂量体积：       2.251mm3
测得的剂量体积(重量法)：188.47mg/83剂＝2.271mg/剂
比值：    0.99
试验2：
剂量期：                  14.92秒
通过电极的时间：          996秒
通过电极的剂量：          67(四舍五入为整数)
剂量体积：                2.251mm3
测得的剂量体积(重量法)：  N/A
比值：                    N/A
试验3
剂量周期：                14.92秒
通过电极的时间：          995秒
通过电极的剂量：          67(四舍五入为整数)
剂量体积：                2.251mm3
测得的剂量体积(重量法)：  184.64mg/83剂＝2.225mg/剂
比值：                    0.99
尽管已参照本发明的示例性实施例对本发明的各个方面进行了描述，应该理解本发明有权要求在所附权利要求的全部范围内受到保护。

Claims (21)

1.一种校准流体泵送装置的流速的方法，所述方法包括：
使用形状记忆元件泵送液体；
检测所述液体到达第一传感器处；
检测所述液体到达第二传感器处；
基于对流动的液体流的干扰，测量从所述液体到达所述第一传感器处到所述液体到达所述第二传感器处所经过的时间；以及
基于确定的校准因数，调节所述装置的分配的体积流速，所述校准因数包括期望剂量体积和实际剂量体积的比值。
2.根据权利要求1所述的方法，其中，所述装置包括一次性部分，并且所述方法进一步包括将所述一次性部分安装到所述装置的可重复使用部分上。
3.根据权利要求2所述的方法，其中，在安装完所述一次性部分之后，对所述分配装置的所述体积流速进行调节。
4.一种便携式药物输送系统，包括：
一次性部件，包括：
形状记忆致动的泵；
药物贮存器；以及
校准区域，所述校准区域具有在该区域的第一部分处的第一传感器和在该区域的第二部分处的第二传感器；以及可重复使用部件，包括处理器，其中基于对流动的液体流的干扰，所述处理器监控液体从所述第一传感器流到所述第二传感器所需要的时间，以及基于期望剂量体积和实际剂量体积的比值来确定校准因数，以便通过形状记忆致动泵修改输送。
5.根据权利要求4所述的药物输送系统，其中，所述处理器监控在所述液体从所述第一传感器流到所述第二传感器所需要的时间期间泵启动的次数。
6.根据权利要求5所述的药物输送系统，其中，所述可重复使用部件的所述处理器针对与所述系统一起使用的每个一次性部件校准药物输送。
7.一种通过活塞驱动的泵输送一定剂量的液体的方法，所述活塞具有行程长度，所述方法包括：
测量所述泵的流速；
基于对流动的液体流的干扰，确定所需剂量，以及基于包括期望剂量体积和实际剂量体积的比值的校准因数，来输送期望的剂量；
确定与所需剂量对应的行程次数；以及
通过使用形状记忆元件使所述活塞移动相应行程次数来输送所需剂量。
8.根据权利要求7所述的方法，其中，移动所述活塞包括通过向形状记忆致动器施加电势来改变所述致动器的形状。
9.根据权利要求7所述的方法，其中，测量所述流速包括：驱动所述泵；
记录由所述泵移动的液体何时通过第一传感器；以及记录由所述泵移动的液体何时通过第二传感器。
10.根据权利要求9所述的方法，其中，所述泵在所述第一和第二传感器之间的部分的容积是已知的，并且测量所述流速进一步包括计算驱动所述活塞以产生所述已知容积的次数。
11.根据权利要求7所述的方法，其中，测量所述流速包括利用一个或多个电极检测液体中的组分。
12.根据权利要求8所述的方法，进一步包括根据来自指示所述活塞的位置的一个或多个传感器的信号的反馈改变所述电势。
13.一种输送液体的方法，所述方法包括：
提供包括泵元件的一次性部件；
提供包括微处理器的耐用部件，所述一次性部件被构造成与所述耐用部件配合并一起操作；
启动液体流使之通过所述装置的具有已知容积的部分，所述流包括多个剂量；
确定泵送所述已知容积所需要的时间；以及
基于对流动的液体流的干扰，确定一个输送剂量的体积。
14.根据权利要求13所述的方法，进一步包括产生所确定的剂量体积与期望的剂量体积的比值。
15.根据权利要求14所述的方法，进一步包括根据所述比值修改剂量输送的频次。
16.根据权利要求13所述的方法，进一步包括使所述耐用部件与所述一次性部件配合。
17.一种输送的方法，所述方法包括：
提供泵元件；
提供包括处理器的控制单元；
启动多个剂量的泵送；
基于对流动的液体流的干扰，测量所述多个剂量中每一个的实际体积；以及
将测量的所述多个剂量中的一个的实际剂量体积与多个测量的所述多个剂量中的所述一个的期望剂量体积进行比较来确定校准因数。
18.根据权利要求17所述的方法，进一步包括根据所述比较计算一比值，并在输送后续剂量中应用该比值。
19.根据权利要求17所述的方法，进一步包括根据所述比较修改剂量输送的频次。
20.一种用于输送液体的微型泵，包括：
泵元件，包括形状记忆元件；
用于测量由所述泵元件提供的单位体积的量的装置；
用于基于对流动的单位体积流的干扰检测所测得的单位体积与期望的单位体积的差的装置；以及
用于根据所述差对所述输送进行修改的装置。
21.一种分配液体的方法，包括：
泵送所述液体；
检测所述液体到达第一传感器处；
检测所述液体到达第二传感器处；
基于对流动的液体流的干扰，测量从所述液体到达所述第一传感器处到所述液体到达所述第二传感器处所经过的时间；
计算所述分配装置的体积流速，以便基于期望剂量体积和实际剂量体积的比值来确定校准因数；以及
调节所述装置的分配的体积流速。
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