CN204972511U - 通过输注而输送药物的微泵 - Google Patents

通过输注而输送药物的微泵 Download PDF

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CN204972511U
CN204972511U CN201520468138.4U CN201520468138U CN204972511U CN 204972511 U CN204972511 U CN 204972511U CN 201520468138 U CN201520468138 U CN 201520468138U CN 204972511 U CN204972511 U CN 204972511U
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piston
pump
micropump
pump housing
cam surface
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K·福赫特
J·戈登
J·菲斯克
M·J·佩里
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Becton Dickinson and Co
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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
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    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means 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
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
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    • F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
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    • F04B19/006—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
    • F04B19/00—Machines or pumps having pertinent characteristics not provided for in, or of interest apart from, groups F04B1/00 - F04B17/00
    • F04B19/02—Machines or pumps having pertinent characteristics not provided for in, or of interest apart from, groups F04B1/00 - F04B17/00 having movable cylinders
    • F04B19/025—Machines or pumps having pertinent characteristics not provided for in, or of interest apart from, groups F04B1/00 - F04B17/00 having movable cylinders cylinders rotating around their own axis
    • 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
    • F04B39/00—Component parts, details, or accessories, of pumps or pumping systems specially adapted for elastic fluids, not otherwise provided for in, or of interest apart from, groups F04B25/00 - F04B37/00
    • F04B39/08—Actuation of distribution members
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
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    • 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
    • F04B49/16—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 by adjusting the capacity of dead spaces of working chambers
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
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    • F04B7/04—Piston machines or pumps characterised by having positively-driven valving in which the valving is performed by pistons and cylinders coacting to open and close intake or outlet ports
    • 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
    • F04B7/00—Piston machines or pumps characterised by having positively-driven valving
    • F04B7/04—Piston machines or pumps characterised by having positively-driven valving in which the valving is performed by pistons and cylinders coacting to open and close intake or outlet ports
    • F04B7/06—Piston machines or pumps characterised by having positively-driven valving in which the valving is performed by pistons and cylinders coacting to open and close intake or outlet ports the pistons and cylinders being relatively reciprocated and rotated
    • 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
    • F04B9/00—Piston machines or pumps characterised by the driving or driven means to or from their working members
    • F04B9/02—Piston machines or pumps characterised by the driving or driven means to or from their working members the means being mechanical
    • F04B9/04—Piston machines or pumps characterised by the driving or driven means to or from their working members the means being mechanical the means being cams, eccentrics or pin-and-slot mechanisms
    • F04B9/042—Piston machines or pumps characterised by the driving or driven means to or from their working members the means being mechanical the means being cams, eccentrics or pin-and-slot mechanisms the means being cams
    • 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
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion 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
    • 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
    • A61M5/168—Means 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
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M2005/16863—Occlusion detection
    • 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
    • A61M2205/10—General characteristics of the apparatus with powered movement mechanisms
    • A61M2205/103—General characteristics of the apparatus with powered movement mechanisms rotating
    • 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
    • A61M5/1413—Modular systems comprising interconnecting elements
    • 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
    • F04B9/00—Piston machines or pumps characterised by the driving or driven means to or from their working members
    • F04B9/02—Piston machines or pumps characterised by the driving or driven means to or from their working members the means being mechanical
    • F04B9/04—Piston machines or pumps characterised by the driving or driven means to or from their working members the means being mechanical the means being cams, eccentrics or pin-and-slot mechanisms
    • F04B9/047—Piston machines or pumps characterised by the driving or driven means to or from their working members the means being mechanical the means being cams, eccentrics or pin-and-slot mechanisms the means being pin-and-slot mechanisms

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  • Engineering & Computer Science (AREA)
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  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

一种通过输注而输送药物的微泵，包括：泵壳体；位于所述泵壳体内的活塞，所述活塞具有纵向的活塞轴线；以及适于使活塞绕所述活塞轴线旋转的马达；所述泵壳体具有容纳所述活塞的轴向开口、相对于所述活塞轴线径向定位并与一容器连通的第一孔、以及相对于所述活塞轴线径向定位的与一套管连通的第二孔；所述活塞在其一端处具有适于在活塞的相应旋转位置处顺序地打开和关闭所述第一孔和第二孔的偏心凸轮表面；所述活塞在所述泵壳体内的轴向位置确定泵容积空间。由此微泵从容器抽吸流体以及将计量的流体提供至套管端口以便配给给病人。该微泵可使用在用于连续输注诸如胰岛素的药物的一次性泵中。

Description

通过输注而输送药物的微泵
技术领域
本实用新型涉及一种适用于通过输注而连续输送液体药物的微泵，所述微泵例如可用于糖尿病治疗用胰岛素的输送。
背景技术
用于药品皮下输送的微泵是已知的，例如，可由美国专利号7,726,955和8,282,366获知。该现有技术在各种实施方式中描述了一种具有安装在定子或者壳体内的转子的泵。在转子的轴向延伸部上成一定角度设置的密封环与形成在转子和定子之间的通道相协作以使液体以精确量通过转子壳体。然而，这些实施方式相对复杂并且不符合成本效益。若干周内用户都要在更换输注胶贴时带着泵。随着技术继续向完全一次性泵发展，对于紧凑且经济可行的微泵设计的要求仍旧强烈。
现有技术中已知的另外一种输注泵包括刚性容器，所述刚性容器具有接合在容器中的丝杠从而在丝杠前进时通过套管分配药物。在这种配置中，用于药物输送的致动器直接连接到丝杠，因而必须非常精确。此外，该装置要求刚性容器提供校准的剂量。因此，不可以使用柔性容器，并且泵的可能的布局数量受到限制。
实用新型内容
在一个方面中，本实用新型提供一种通过输注而输送药物的微泵，所述微泵包括：泵壳体；位于所述泵壳体内的活塞，所述活塞具有纵向的活塞轴线；以及适于使所述活塞绕所述活塞轴线旋转的马达。该泵壳体具有容纳所述活塞的轴向开口、相对于所述活塞轴线径向定位的与一容器流体连通的第一孔、以及相对于所述活塞轴线径向定位的与一套管流体连通的第二孔。所述活塞在其一端处具有适于在所述活塞的相应旋转位置处顺序地打开和关闭所述第一孔和第二孔的偏心凸轮表面。所述活塞在所述泵壳体内的轴向位置确定泵容积空间。
优选地，泵壳体是静止的，并且所述微泵还包括位于所述活塞上的轴向位置凸轮表面，所述轴向位置凸轮表面位于所述马达与所述偏心凸轮表面之间，与所述泵壳体上的静止部件接合，并且适于在所述活塞旋转时在所述泵壳体内轴向平移所述活塞。
优选地，泵壳体上的静止部件是容纳在所述泵壳体上的孔内的凸轮销。
优选地，所述活塞能自由地旋转、但具有固定的轴向位置，所述泵壳体能自由地轴向平移、但具有固定的旋转位置。
优选地，所述微泵还包括位于所述马达与所述活塞之间的连接器，所述连接器在所述马达与所述活塞之间传递扭矩并接合所述活塞以允许所述活塞相对于所述连接器作轴向运动以及阻止所述活塞相对于所述连接器作旋转运动。
优选地，所述微泵的活塞上的轴向长形槽缝接合所述连接器上的凸片以允许所述活塞相对于所述连接器作轴向运动以及阻止所述活塞相对于所述连接器作旋转运动。
优选地，所述第一孔和所述第二孔均容置有O型环密封件和弹簧加载的阀致动器，每个所述阀致动器具有一末端，两个阀致动器的末端在常闭位置与所述偏心凸轮表面之间有间隙，并且所述O型环密封件上的弹簧力足够大以确保阀致动器不会在微泵的工作压力下打开，其中，所述偏心凸轮表面在活塞旋转时顺序地偏压每个阀致动器，从而释放所述O型环密封件上的压缩并且分别容许流体流过所述第一孔和所述第二孔。
优选地，所述微泵还包括微处理器和行程传感器，所述行程传感器具有在整个循环中由所述活塞的旋转触发的与所述微处理器通讯的接触开关。
优选地，所述容器具有至少一个柔性壁。
优选地，所述微泵还包括能够由用户穿戴的容纳所述微泵的外壳体、动力源和套管展开系统。
优选地，所述套管展开系统通过所述马达的旋转触发。
优选地，所述微泵还包括位于所述外壳体上的显示器和用户操作的控制器。
优选地，所述微泵还包括位于所述外壳体上的孔，该位于所述外壳体上的孔带有具有入口以充注所述容器的端口。
优选地，所述微泵还包括微处理器、套管展开机构、与所述容器操作性地通讯的容积传感器、与所述微泵的活塞操作性地通讯的行程传感器、以及与位于所述泵壳体上的第二孔与所述套管之间的流体线路操作性地通讯的错误状态传感器，其中，所述马达、所述套管展开机构、所述容积传感器、所述行程传感器和所述错误状态传感器都与所述微处理器操作性地通讯。
在另一个方面中，本实用新型提供一种利用上述泵通过输注而输送药物的方法，所述方法包括如下步骤：向微处理器提供指令以展开套管并且使活塞旋转；将一定体积的药物从容器抽吸到泵容积空间内；以及通过套管排放该一定体积的药物，以便向病人输注一输注剂量。
优选地，药物为胰岛素，并且输注剂量包括1至5天的输注量。
优选地，输注剂量包括基础段和至少一个大剂量段。
优选地，该方法还包括输送完输注剂量之后废弃泵。
优选地，所述泵容积空间在1μl到10μl的范围内，并且输注剂量以活塞360度旋转的整数转进行输送。
优选地，提供至微处理器的指令是利用位于能够穿戴的泵壳体上的用户操作控制器进行编程的。
附图说明
图1是根据本实用新型的流体计量和输送系统的示意性概览图。
图2是组装后的流体计量和输送系统的视图。
图3是流体计量系统的分解图。
图4A和图4B是流体计量系统的泵活塞元件的俯视图和端视图。
图5和图6是计量系统的横截面视图。
图7是处于泵循环开始位置的泵壳体的横截面视图。图7A和图7B是处于图7所描绘的阶段的流体输送系统从不同角度来看的相应局部剖视图。
图8是处于泵循环前期阶段、吸入冲程开始之前的泵壳体的横截面视图。
图9是吸入冲程期间的泵壳体的横截面视图。图9A和图9B是从不同角度来看的相应局部剖视图。
图10是吸入冲程之后的泵壳体的横截面视图。图10A和图10B是从不同角度来看的相应局部剖视图。
图11是排出冲程启动之前的泵壳体的横截面视图。图11A和图11B是从不同角度来看的相应局部剖视图。
图12是排出冲程期间的泵壳体的横截面视图。图12A和图12B是排出冲程期间的流体输送系统从不同角度来看的相应局部剖视图。
图13描绘了处于泵循环结束的活塞的旋转位置。
具体实施方式
图1给出了流体输送系统100的示意性概览图，所述流体输送系统包括与计量子系统200流体连通的容器120，所述计量子系统用于从容器内抽吸精确量的流体。提供套管机构122用于将药物从计量子系统200输送到用户101。包括计量子系统200的流体输送系统优选为重量轻的、耐用的并且以如图2所示的紧凑方式组装，使得各元件被容置在单个壳体内。套管机构122可通过包括导管和胶贴的输注套件连接到输注部位，或者可替代地，一套管插入机构可以连同计量子系统200一起结合到壳体内。
在各实施方式中，泵适于提供1至5天的连续输注剂量。例如，在胰岛素输注的情况下，泵会被穿戴并在84小时后废弃，容器的尺寸设计为将具有基础段和大剂量段形式的给药方案设成随着时间变化的固定容积脉冲系列。这种输注分布被分成基础段和大剂量段。例如，基础段可以是时滞范围从0.17小时/脉冲到1.2小时/脉冲的5μl脉冲准连续流，而大剂量段包括基本上出现在就餐时间前后的以最大泵送流速(最小泵循环时间)进行输送的离散量，一般在10μl到500μl范围内。在胰岛素输注的情况下，容器120可适于容纳1ml到5ml的药物，优选容纳大约3ml的药物。然而，该值不是严格限定的。虽然本实用新型不局限于任一特定容器实施方式，但是容器120优选是柔性的并且不像许多现有技术的胰岛素泵那样与柱塞和丝杠接合。柔性容器没有用于输送流体的内部致动器机构，这允许整个泵具有较小的尺寸和更紧凑的设计。合适的柔性容器可以包括由医用级柔性聚氯乙烯(PVC)或类似材料制成的袋子。可替代地，可以将单个医用级塑料刚性壁结合到柔性壁而形成容器。容器120可通过例如注射器121经由充注端口123进行充注，或者可以使用预充注容器或筒。计量子系统200可配置为与充注端口123流体连通，使得计量子系统200可用来从外部药物源经由充注端口123充注容器120。
微控制器30设在印刷电路板(PCB)或者类似物上，并且与传感器和电路11、12、13、14、15、17以及与致动器16、18接口连接，以控制泵和套管。动力由壳体内的一个或多个电池19提供。显示器和用户操作控制器(未示出)可以设在可操作地连接到PCB的单元上或者设在远程编程单元上，以设置和启动剂量的基础段和大剂量段，正如现有技术中已知的那样。
依照附图中描述的本实用新型的计量系统的实施方式包括带有集成式流量控制阀的容积泵以及机械致动器和驱动系统。在图2所示的实施方式中，致动器是由电池19供电的直流齿轮马达24，然而，也可以采用其他马达系统用于本实用新型，包括螺线管、镍钛诺(镍钛合金)线材用马达、音圈致动器马达、压电马达或者蜡马达。各元件布置在容纳于将穿戴在病人身上的壳体(未示出)中的支撑件21上。
正如图3的分解图所示，马达24容纳在静止不动的马达壳体23中。连接器25容纳马达24的马达轴22并将扭矩从马达传递至泵活塞27。正如这里所用的，“轴向”方向是沿着马达轴的轴线，而“径向”方向是相垂直的方向。除非上下文明确要求，“顺时针”方向是指朝马达俯视马达轴的轴线的顺时针。活塞27上的槽缝39容纳连接器25上的凸片26，使得活塞27与马达轴一致地旋转，但是仍可自由地轴向移动。可替代地，活塞可以具有旋转自由度，但轴向位置固定，并且泵壳体可以可旋转地固定且连接到活塞以允许轴向平移。在任一情形下，泵容积都由活塞在泵壳体内的轴向位置确定。
在所示实施方式中，泵活塞27容纳在静止泵壳体29上的轴向开口内并且封闭泵壳体中在弹性体密封件37之后的泵容积空间47。如图4A所示，活塞27配置有轴向位置凸轮表面32。正如接下来所描述的，轴向凸轮表面32接合静止泵壳体29上的一部件并在马达轴22旋转时使活塞27在壳体29内轴向平移。例如，在所示实施方式中，接合凸轮表面的部件为通过泵壳体插入的销31。
计量子系统200适于将精确体积的流体从柔性容器120引入到泵容积47内，然后通过套管122将流体以小的离散剂量排放到注射部位。合适的泵容积空间47可以具有1μl到10μl的容积，优选具有大约5μl的容积，使得泵活塞27转两圈输送一个单位(U)的胰岛素。重要地，泵活塞27在泵壳体29内部的位置确定冲程，泵壳体的内径确定剂量的精度和公称大小。因此剂量精度不是由马达轴输送相应量的药物的特定旋转位置确定，并且旋转泵循环的开始/停止点不需要精确。泵容积47可通过改变活塞27和/或泵壳体29的直径进行改变。在各实施方式中，套管展开由马达24的旋转以单步展开和输注操作进行触发。
为了在吸入冲程期间将液体引入到泵容积47内以及为了在排出冲程期间排放流体，活塞27设置有偏心凸轮表面33，如图4B所示，以在泵冲程每个端点处使阀致动而顺序地打开和关闭容器流体端口42和套管流体端口41，从而确保流体从容器单向地流向病人以及确保不存在从病人流向容器的可能性。如图5的横截面视图所示，泵壳体设置有相对于泵活塞轴线径向定位的第一和第二孔43、44。孔44提供泵容积47和容器端口42之间的流体连通，而孔43提供泵容积47和套管端口41之间的流体连通。在该实施方式中，孔43、44定位在泵壳体29的相对侧上，并相对于活塞27间隔开180度。用于泵循环的每段的角度分配可根据需要进行调整以优化泵的性能，所述调整通过改变偏心凸轮表面33的尺寸和斜度来增大或减小泵循环的特定部分的角度分配而进行，或者所述调整通过改变孔33、34的径向位置而进行。
在所示实施方式中，第一和第二孔43、44均容纳一阀结构。每个阀结构都包括相应的阀致动器28、28’和环绕孔的相应O型环密封件34、34’，阀致动器在相应弹簧35、35’的力作用下压缩相应的O型环密封件34、34’以在凸轮表面33未压在致动器28、28’上时关闭相应的孔43、44。当凸轮表面33旋转到位并且压下阀致动器28或28’时，通向套管端口41或容器端口42的流体线路打开。弹簧35、35’通过相应的阀帽36、36’在阀座中保持被偏压状态并且必须保证足够的弹簧力来防止在使用该装置期间遇到的背压作用下的回流。虽然在该实施方式中描述了O型环，但是本领域中已知的其他密封系统也可适用于该目的，例如V形阀座中的弹性体球，二次成型V形提升阀，或可被偏压以使流体通过孔43、44进入的二次成型膜。一般来说，计量子系统的各部件是由刚性医用级塑料制成的，例如用于所有泵部件的丙烯腈-丁二烯-苯乙烯(ABS)，而具有20到50肖氏A硬度的液体硅橡胶(LSR)用于密封件。如果需要，LSR密封件可直接模制在硬质塑料基体上，在这种情形下基体部分应由具有更高软化温度的塑料材料制成，例如聚醚酰亚胺(PEI)或聚砜(PS)。
在所描述的实施方式中，泵壳体29是静止的，活塞27在泵壳体29内平移。为此，活塞27包括凹槽32形式的轴向位置凸轮表面。如图4A中所见，在活塞27的与马达24相对的端部上，凹槽32包括朝向马达24定位的近侧凸耳32b和朝向偏心凸轮表面33定位的远侧凸耳32a。静止部件，例如销31，通过开口被容纳在泵壳体内，并且在马达轴22旋转时驱使活塞沿着凹槽32的轴向平移部分被引导而在轴向凸耳32a和近侧凸耳32b的位置之间往复轴向运动。本领域普通技术人员应该理解，活塞27上接合泵壳体29的轴向凸轮表面可以以各种方式实施以提供活塞27的轴向运动。例如，一凹槽可以位于泵壳体上而非位于活塞上。
完整的泵循环需要在一个方向上旋转360度。在相反方向上旋转马达轴22将引起流体在相反方向上流动。在各实施方式中，泵可设置成与充注端口123流体连通以通过在相反方向上旋转马达轴而从诸如药瓶的外部源充注容器。
将参考完整的顺时针旋转(朝马达俯视活塞观察)描述泵循环。偏心凸轮表面33绕活塞轴线的旋转(在该实施方式中，该旋转伴随有活塞27的往复运动)可以通过参考接下来在图7至图13中描述的泵循环的顺序步骤来理解：(1)容器阀打开状态，(2)泵吸入冲程；(3)容器阀关闭状态；(4)套管阀打开状态；(5)泵排出冲程；和(6)套管阀关闭状态。
图7是从泵壳体端部朝马达俯视活塞的横截面视图，显示了处于开始位置的计量系统。泵活塞27完全伸展。如图7A和图7B所示，销31在该位置搁置在近侧凸耳32b上，并且活塞没有轴向平移。凸轮表面33不与任一阀致动器28或28’接合，并且在凸轮表面33与位于泵壳体的径向相对侧上的致动器28和28’之间设置有微小间隙。可以说凸轮表面33在这种状态下与致动器末端“有间隙”。在这种状态下，阀由作用在O型环密封件34、34’上的弹簧力通过阀致动器28和28’关闭。在最初状态下，阀致动器28和28’靠着阀帽36和36’被弹簧加载，使得它们具有足以防止在该装置的操作背压下泄漏的永久偏压力。阀致动器可搁置在孔43、44周围的泵壳体的肩部上。这样，O型环密封件34或34’的压缩由与孔43、44周围的泵壳体表面相协作的阀致动器的几何形状确定，而不是仅仅由弹簧力确定。
图8描绘了吸入冲程开始之前的容器阀打开状态(1)。马达24显示为沿顺时针方向旋转，使得活塞27上的凸轮表面33旋转以接触阀致动器28来偏压弹簧35并打开与容器端口42的流体连通。在该位置，销31仍未进入凹槽32的倾斜轴向平移部分。
在图9、图9A和图9B所描绘的泵吸入冲程(2)期间，致动器28被完全压下。流体通过容器端口42和孔44流入到泵容积空间47中，而孔43保持关闭。如图9A和图9B所示，销31接合轴向凸轮表面32的倾斜部分，从而使活塞27在箭头99所示的方向上朝马达24平移。流体如箭头98所示那样被抽吸到泵容积空间47中。当销31搁置在远侧凸耳32a上时，吸入冲程完成，活塞27的轴向运动停止。驱动器28保持完全压下，而驱动器28’与凸轮表面33保持有间隙。
图10、图10A和图10B显示了容器端口42关闭的状态。活塞27的旋转使凸轮表面33释放致动器28，从而在弹簧35的偏压作用下再次压缩密封件34，并阻止流体流过孔44。在这部分泵循环期间，销31搁置在远侧凸耳32a上，防止活塞27轴向平移。
图11显示了套管阀的打开状态(4)。活塞27的旋转使凸轮表面33接合致动器28’，从而释放对O型环密封件34’的压缩，并且通过孔43打开泵容积47与套管端口41之间的流体连通。图11A和图11B显示了在这部分泵循环期间，销31搁置在远侧凸耳32a上，防止活塞27轴向平移。
在如图12、图12A和图12B所描绘的泵排出冲程(5)期间，偏心凸轮33保持打开与套管端口41的流体连通，而容器端口42保持关闭。图12A显示了在如箭头所示的远侧方向上轴向移动的活塞27。销31接合凸轮表面32的倾斜轴向平移部分，如图12B所示，从而使活塞27远离马达24平移并且使流体如箭头所示通过套管端口41从泵容积空间47排出。
在活塞已经完成360度旋转后，如图13中所描绘的，传感器38被接合，指示泵循环完成。通过使泵返回到套管阀关闭状态(6)，容器端口42和套管端口41被封堵并且销31搁置在近侧凸耳32b上。在所示实施方式中，传感器38为检测泵已经完成全循环的ON/OFF开关。然而，其他传感器系统，例如编码轮和光学传感器，也可用来识别中间状态并将该信息通讯至微处理器30。较高分辨率传感器的使用允许排出冲程递增。在此描述的实施方式中，排出冲程包括活塞27的完整旋转，从而排空泵容积47的内容物，然而，在不脱离本实用新型范围的情况下，可以实现输注剂量的更高分辨率。
优选实施方式的前述说明不应视为本实用新型的限制，本实用新型是由所附的权利要求进行限定的。根据前述公开内容，本领域普通技术人员可以实施所描述的实施例的变形而不脱离所要求保护的本实用新型的范围。例如，尽管是结合用于糖尿病治疗的胰岛素连续输送进行的描述，但是对本领域普通技术人员来说显而易见的是，胰岛素泵可以适于输送其他药物。结合一个实施方式或者独立权利要求描述的特征或者从属权利要求限定部分可以适于与另一个实施方式或者独立权利要求一起使用而不脱离本实用新型的范围。

Claims (14)

1.一种通过输注而输送药物的微泵，其特征在于，所述微泵包括：
泵壳体；
位于所述泵壳体内的活塞，所述活塞具有纵向的活塞轴线；以及
适于使所述活塞绕所述活塞轴线旋转的马达；
所述泵壳体具有容纳所述活塞的轴向开口、相对于所述活塞轴线径向定位并与一容器连通的第一孔、以及相对于所述活塞轴线径向定位的与一套管连通的第二孔；
所述活塞在其一端处具有适于在所述活塞的相应旋转位置处顺序地打开和关闭所述第一孔和所述第二孔的偏心凸轮表面；其中，
所述活塞在所述泵壳体内的轴向位置确定泵容积空间。
2.根据权利要求1所述的微泵，其特征在于，所述泵壳体是静止的，并且所述微泵还包括位于所述活塞上的轴向位置凸轮表面，所述轴向位置凸轮表面位于所述马达与所述偏心凸轮表面之间，与所述泵壳体上的静止部件接合，并且适于在所述活塞旋转时在所述泵壳体内轴向平移所述活塞。
3.根据权利要求2所述的微泵，其特征在于，所述泵壳体上的静止部件是容纳在所述泵壳体上的孔内的凸轮销。
4.根据权利要求1所述的微泵，其特征在于，所述活塞能自由地旋转、但具有固定的轴向位置，所述泵壳体能自由地轴向平移、但具有固定的旋转位置。
5.根据权利要求1所述的微泵，其特征在于，所述微泵还包括位于所述马达与所述活塞之间的连接器，所述连接器在所述马达与所述活塞之间传递扭矩并接合所述活塞以允许所述活塞相对于所述连接器作轴向运动以及阻止所述活塞相对于所述连接器作旋转运动。
6.根据权利要求5所述的微泵，其特征在于，所述微泵的活塞上的轴向长形槽缝接合所述连接器上的凸片以允许所述活塞相对于所述连接器作轴向运动以及阻止所述活塞相对于所述连接器作旋转运动。
7.根据权利要求1所述的微泵，其特征在于，所述第一孔和所述第二孔均容置有O型环密封件和弹簧加载的阀致动器，每个所述阀致动器具有一末端，两个阀致动器的末端在常闭位置与所述偏心凸轮表面之间有间隙，并且所述O型环密封件上的弹簧力足够大以确保阀致动器不会在微泵的工作压力下打开，其中，所述偏心凸轮表面在活塞旋转时顺序地偏压每个阀致动器，从而释放所述O型环密封件上的压缩并且分别容许流体流过所述第一孔和所述第二孔。
8.根据权利要求1所述的微泵，其特征在于，所述微泵还包括微处理器和行程传感器，所述行程传感器具有在整个循环中由所述活塞的旋转触发的与所述微处理器通讯的接触开关。
9.根据权利要求1所述的微泵，其特征在于，所述容器具有至少一个柔性壁。
10.根据权利要求1所述的微泵，其特征在于，所述微泵还包括能够由用户穿戴的容纳所述微泵的外壳体、动力源和套管展开系统。
11.根据权利要求10所述的微泵，其特征在于，所述套管展开系统通过所述马达的旋转触发。
12.根据权利要求10所述的微泵，其特征在于，所述微泵还包括位于所述外壳体上的显示器和用户操作的控制器。
13.根据权利要求1所述的微泵，其特征在于，所述微泵还包括位于所述外壳体上的孔，该位于所述外壳体上的孔带有具有入口以充注所述容器的端口。
14.根据权利要求1所述的微泵，其特征在于，所述微泵还包括微处理器、套管展开机构、与所述容器操作性地通讯的容积传感器、与所述微泵的活塞操作性地通讯的行程传感器、以及与位于所述泵壳体上的所述第二孔与所述套管之间的流体线路操作性地通讯的错误状态传感器，其中，所述马达、所述套管展开机构、所述容积传感器、所述行程传感器和所述错误状态传感器都与所述微处理器操作性地通讯。
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