CN109420216A - 具有低体积传感器的储器 - Google Patents

具有低体积传感器的储器 Download PDF

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CN109420216A
CN109420216A CN201811006576.3A CN201811006576A CN109420216A CN 109420216 A CN109420216 A CN 109420216A CN 201811006576 A CN201811006576 A CN 201811006576A CN 109420216 A CN109420216 A CN 109420216A
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sensor
reservoir
flexible reservoir
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plunger
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J·R·格罗里
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Becton Dickinson and Co
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Abstract

一种医疗装置，其用来对使用者进行液体药物治疗，具有体积传感器。所述医疗装置包括：柔性储器，所述柔性储器用来容纳待被供应的液体药物；刚性结构，所述刚性结构具有室以及与所述柔性储器流体连通的侧孔；柱塞，所述柱塞安装在所述室内并且被构造用来密封所述室的一侧；以及开关，所述开关被实施用来指示柱塞的位置。当所述柱塞的内端部经过所述侧孔时，所述开关被激励以传输指示所述柔性储器中的液体体积的信号。

Description

具有低体积传感器的储器
技术领域
总体而言，本发明涉及用来输送液体的储器。本发明的一个具体实施例涉及用来输送液体医药产品(诸如胰岛素)的具有低体积传感器的柔性储器。另一个实施例提供用来操作具有低体积传感器的柔性储器的方法，该方法包括提供需要更换柔性储器的警示。
背景技术
糖尿病是一组疾病，其特征在于由糖尿病患者当需要时不能维持适当水平的胰岛素生产引起的高水平的血糖。有糖尿病的人将需要一些形式的每日胰岛素治疗以维持他们的血糖水平的控制。糖尿病对于患病的患者来说可能是危险的(如果它不被治疗)并且它可能导致严重的健康并发症和过早离世。然而，这些并发症可以通过使用一个或更多个治疗选择来帮助控制糖尿病并且减小并发症的危险而被最小化。
用于糖尿病患者的治疗选择包括专门的饮食、口服用药和/或胰岛素疗法。糖尿病治疗的主要目标是控制糖尿病患者的血糖或糖水平。然而，维持适当的糖尿病管理可能是复杂的，因为它必须与糖尿病患者的活动相平衡。
对于1型糖尿病的治疗，存在每日胰岛素治疗的两种主要方法。在第一种方法中，糖尿病患者当需要时使用注射器或胰岛素笔针来自行注射胰岛素。这种方法对于每一次注射需要针刺，并且糖尿病患者可能每日需要三到四次注射。用于注射胰岛素的注射器和胰岛素笔针，其使用相对简单，且成本划算。
用于胰岛素治疗和管理糖尿病的另一种有效方法是输注治疗，其中使用胰岛素泵。胰岛素泵可以以变化的速率将胰岛素连续地注入糖尿病患者，以便更紧密地匹配非糖尿患者的适当操作的胰腺(该胰腺产生所需的胰岛素)的功能和行为，并且该胰岛素泵可以基于糖尿病患者的个人需要而帮助糖尿病患者将他/她的血糖水平维持在目标范围内。
为了方便输注疗法，通常存在两种类型的胰岛素泵，即，常规泵和贴附泵。常规泵需要使用一次性部件(典型地称为注入装置、管道装置或泵装置)，该一次性部件将胰岛素从泵内的储器传送到使用者的皮肤中。相比之下，贴附泵是一种集成式装置，这种集成式装置将各个流体部件(包括流体储器、泵送机构以及用来自动插入套管的机构)中的大部分或全部部件都组合在单个壳体中，该单个壳体以粘贴方式附接到患者皮肤上的输注点处，而不需要使用分离的输注或管道装置。一些贴附泵可以与分离的控制器无线地通信(如在以商标名由Insulet公司出售的一种装置中)，而其它是完全自给的(self-contained)。当胰岛素储器被耗尽时，这种装置以一定频率(诸如每隔三天)被更换。
由于贴附泵被设计成由糖尿患者穿戴的自给单元，优选的是尽可能小，使得它不干涉使用者的活动。然而，为了使贴附泵的总尺寸最小化，其构成部分应当尽可能大幅度地减小尺寸。一个这种部分是用来包含胰岛素的储器。
常规刚性储器(诸如注射器泵)控制柱塞的位置以分配液体。这种机构的主要制约因素是系统的尺寸，因为它需要包容储器的长度和柱塞的长度。因此，常规刚性储器难以以紧凑的构造而部署。因此，需要一种改进的储器，该改进的储器可以以紧凑的构造高效地部署，以进一步减小贴附泵的总尺寸。
储器中的低液位检测，对于保证贴附泵系统正确地运行和/或信号告知需要更换储器或贴附泵而言，是重要的。各种填充水平检测系统已经被提出用于各种不同应用。目前，存在用于填充水平检测的两种主要方法。一种方法提供电接触点以便计量剂量。另一方法使用电容测量而实施无接触填充水平检测。
当流率和填充水平需要被不断监视和/或调节时，常规填充水平检测系统有许多优点。常规填充水平检测系统不断地或在多个时间点提供精确的填充水平数据。在不断的监视和调节是必要的情况下，这种系统是非常适合的。当仅仅需要低体积警示来发信号告知需要更换储器时，具有填充水平检测功能的系统不必要地过于昂贵而且过于复杂。
用来减小贴附泵的总尺寸的方法是用从流体储器吸取的下游泵系统取代注射器式配量机构。在这种装置中，小型化的泵被布置在流体储器下游以产生负压力梯度，该负压力梯度将流体从储器传送到其目的地。小型化的泵可以替代地被布置用来产生正压力梯度，该正压力梯度将流体从另一较大的流体源传送到储器中以填充该储器。
因此，在本技术领域中需要提供一种紧凑的且更为经济划算的储器，该储器具有低体积检测器以便警示需要更换储器，使得更多糖尿患者可以受益于贴附泵装置提供的优点。
发明内容
本发明的例示性实施例的一个目标是提供一种具有低体积检测器的柔性液体储器。本发明的例示性实施例的另一个目标是提供柔性储器中的低液位的告知。
根据本发明的一个方面，提供一种医疗装置，其用来对使用者进行液体药物治疗，具有低体积传感器，所述医疗装置包括：柔性储器，该柔性储器用来包含待被供应的液体药物；刚性结构，该刚性结构具有室以及与柔性储器流体连通的侧孔；柱塞，该柱塞安装在室内并且被构造用来密封室的一侧；以及传感器，该传感器用来检测柔性储器中的低液体体积，其中，当柱塞的内端部经过侧孔时，传感器被激励以传输指示柔性储器中的低液体体积的信号。
本发明的第二方面提供一种医疗系统，其用来对使用者进行液体药物治疗，具有低体积传感器，所述医疗系统包括：柔性储器，该柔性储器用来包含液体；泵机构，该泵机构与柔性储器流体连接以便将液体从柔性储器中泵出；传感器装置，该传感器装置用来检测柔性储器内的流体体积；以及控制模块，该控制模块与传感器功能性地连接以便从传感器接收体积信号。
本发明的第三方面提供一种用来在系统中检测低液体体积并且向使用者告知清空时间的方法，该系统包括：泵机构；柔性储器，该柔性储器用来容纳待被供应的液体药物；刚性结构，该刚性结构具有室以及与柔性储器流体连通的侧孔；柱塞，该柱塞安装在室内并且被构造用来密封室的一侧；传感器，该传感器用来检测柔性储器中的低液体体积；以及控制模块，该控制模块与泵机构功能性地连接，以便控制泵机构的操作，其中，当柱塞的内端部经过侧孔时，传感器被激励以传输指示柔性储器中的低液体体积的信号，所述方法包括以下步骤：提供刚性结构，该刚性结构具有连接到柔性储器的室；将负压力施加到刚性结构的端部A；从柔性储器移除流体；检测柱塞与开关脱离接触的时刻；基于当前流率以及室和导管的体积，计算估计的清空时间；向使用者警示：体积是低的；以及向使用者告知系统将用完液体的大致时间。
根据以下详细描述，本发明的其它目标、优点和突出特征对于本领域技术人员来说将变得显明，该详细描述结合附图公开本发明的例示性实施例。
附图说明
当结合附图时，根据本发明的某些例示性实施例的以下描述，本发明的某些例示性实施例的上述和其它例示性特征和优点将变得更显明，附图中：
图1是描绘根据本发明的一个实施例的医疗装置的图示；
图2是图1的医疗装置的空状态的图示；
图3是图1的医疗装置的填充状态的图示；
图4是在贴附泵系统中实现的柔性储器的立体图；
图5是图4的贴附泵系统的流体体系结构和计量子系统简图；而
图6是流程图，其中示出用来检测低液体体积和用来向使用者告知估计的清空时间的方法。
在各个附图中，相似的附图标记将被理解为指的是相似的要素、特征和结构。
具体实施方式
本描述中例示的内容用来辅助对于本发明的例示性实施例的全面理解，并且参考附图而进行描述。本领域技术人员将认识到，可以对这里描述的例示性实施例做出各种改变和修改而不偏离要求保护的发明的范围和精神。而且，为了清楚和简洁起见，省略了对于公知功能和构造的描述。
如图1中所示，本发明的一个例示性实施例包括：柔性储器101，该柔性储器用来容纳待被供应的液体药物；刚性结构120，该刚性结构具有室102以及与柔性储器101流体连通的侧孔104；以及柱塞105，该柱塞安装在室内并且被构造用来密封室102的一侧。术语“柔性储器”包括如下二者：完全柔性的储器结构(诸如可收缩的流体袋或囊)；以及借助具有柔性壁部分和刚性壁部分二者、从而仅仅在局部具有柔性的储器结构。室102的出口/入口103允许流体进入和离开室102。柱塞105能够沿室102的轴向方向从端部A移动到端部B，以便填充该室，或者替代地从端部B移动到端部A，以便清空该室。柱塞105被布置在该室102中，使得它防止液体漏出室102。当柱塞105从端部A移动到端部B以便填充时，流体源连接到端部A。当柱塞105经过侧孔104时，流体填充该室102并且通过侧孔104流入柔性储器101直到柔性储器101充满。同时，传感器106被触发以传输体积信号。当柱塞105从端部B移动到端部A以便清空时，柔性储器101首先被清空。当柱塞105经过侧孔104时，柔性储器101被清空。传感器106再被触发以传输另一体积信号以指示储器中的低流体体积。
本领域技术人员将理解，图1中示出的医疗装置可以被构造用来当传感器106是电开关时充分地发挥功能。例如，当柱塞105经过侧孔104时，从传感器106传输电信号以指示体积信息。传感器106也可以替代地使用光学传感器而实现。例如，当柱塞105经过侧孔104时，从传感器106传输光学信号以指示体积信息。替代地，传感器106可以使用磁传感器而实现。
当清空柔性储器101时，泵或装置可以布置在柔性储器101和室102的下游以产生负压力，该负压力将流体从柔性储器101传送到其目的地。当填充柔性储器101时，类似的装置可以被布置用来产生正压力，该正压力通过出口/入口103将流体从另一流体源传送到柔性储器101中。
在本发明的一个例示性实施例中，传感器106是与室102的端部B对准的电开关。开关106的按钮或致动器107指向室102的开口。当柱塞105从端部A移动到端部B并且经过侧孔104时，柱塞105的端部接触电开关的按钮107并且触发开关106以传输体积信号。本领域技术人员将理解，另外的支承和容纳结构可以存在以支承和容纳上述部件。
图2是具有泵机构的本发明的低体积状态的图示。为了清空柔性储器101，泵机构110位于柔性储器101的下游。柱塞105的最初位置是在位置B中。泵机构在室102和柔性储器101内的流体上产生负压力。柔性储器101内的流体通过侧孔104流到室102中，并且通过室出口/入口103流到导管111到达泵机构110。负压力引起柔性储器101首先被清空。当柔性储器101被清空时，来自泵机构110的持续的负压力引起柱塞105从位置B向着位置A移动，并且开关106上的按钮107被激励以将低体积信号传输至控制模块109。控制模块109然后将低体积警示信号发送给使用者。
图3是图2的装置的高体积状态的图示。为了填充柔性储器101，填充注射器或其它装置用于迫使注射流体通过阀或密封件而到达出口/入口103中。柱塞105的最初位置是位置A。柱塞105被填充装置产生的室102内的正压力推回。当柱塞105经过室102中的侧孔104时，流体开始通过侧孔104流入柔性储器101。当柔性储器101被流体填充时，正压力增大并且将柱塞105进一步推回到位置B以激发开关106上的按钮107以便将高体积信号传输至控制模块109。然后，泵装置110可以以预定速度开始运行，柔性储器101中的液体将被泵送到使用者并且柔性储器101将如图2中所示被清空，此时，传感器106将被激励以传输低液体体积信号。
图4是实施在贴附泵1A(被示出为没有盖子)中的柔性储器101的立体图。在柔性储器101填充贴附泵1A内的空隙的情况下，这种布置还可以减小贴附泵1A的外尺寸。贴附泵1A被示出为具有套管插入装置7A，该套管插入装置将套管插入使用者的皮肤的表面。贴附泵1A还包括：呈电池的形式的能量源5A；计量子系统41，该计量子系统监视胰岛素的体积并且包括低体积检测装置；控制电子设备8A，该控制电子设备用来对装置的部件加以控制；以及储器填充端口43，该储器填充端口用来接纳填充注射器45以填充储器101。
图5是图4的贴附泵1A的流体体系结构和计量子系统简图。用于贴附泵1A的能量存储子系统包括电池5A。贴附泵1A的控制电子设备8A可以包括：微控制器81、感测电子设备82、泵和阀控制器83、感测电子设备85以及部署电子设备87，这些电子设备控制贴附泵1A的操作。贴附泵1A包括流体子系统，该流体子系统包括：储器101、用于储器101的体积传感器48以及储器填充端口43，该储器填充端口用来接纳填充注射器45以填充储器101。流体子系统可以包括计量系统，该计量系统包括泵和阀致动器411和成一体的泵和阀机构413。流体子系统还可以包括：闭塞传感器49、部署致动器或套管插入装置7以及套管47，该套管用来插入使用者的皮肤上的输注点。在本发明的一个实施例中，体积传感器以图1、2和3的传感器106而实现。
图6是流程图，其中示出的方法用来向使用者发出关于低液体体积的警示，并且用来向使用者告知所估计的清空时间。在步骤602中，当柔性储器101通过施加负压力到室102的端部A而被清空时，流体流出柔性储器101并且流过室102。在步骤603中，上述步骤继续，直到所有的流体都从柔性储器101被移除。在这个时刻，负压力将积累，直到它足以引起柱塞105在室102中向前滑动。当柱塞105开始移动时，柱塞105的后边缘将与开关的按钮107脱离接触，使得低体积信号被传输至控制模块109。在步骤604中，柱塞105与开关106的按钮107脱离接触的时刻被检测。在这个时刻在系统中剩余的精确体积是已知的，这是由于它等于导管111和没有被柱塞105占据的室102的那部分的体积。在步骤605中，将这个体积除以液体的当前流率(该当前流率从泵机构110的操作速度已知)获得该系统变得没有流体之前留下的估计的时间量。在步骤606中，系统的使用者被警示：体积是低的。如果流率是已知的，则在步骤607中，使用者可以被告知系统将用完流体的大致时间。
本领域技术人员将理解，上述例示性实施例的特征可以在许多应用中被类似地提供并且不限于上述公开。
虽然本发明已经参考特别的说明性实施例被示出且描述，但它将不由例示性实施例限制，而是仅由所附权利要求和它们的等同物限制。将理解，本领域技术人员可以对例示性实施例做出改变或修改而不偏离本发明的范围和精神。

Claims (14)

1.一种医疗装置，所述医疗装置用来对使用者进行液体药物治疗，具有低体积传感器，所述医疗装置包括：
柔性储器，所述柔性储器用来包含待被供应的液体药物；
刚性结构，所述刚性结构具有室以及与所述柔性储器流体连通的侧孔；
柱塞，所述柱塞安装在所述室内并且被构造用来密封所述室的一侧；以及
传感器，所述传感器用来检测所述柔性储器中的低液体体积，其中：
当所述柱塞的内端部经过所述侧孔时，所述传感器被激励以传输指示所述柔性储器中的低液体体积的信号。
2.如权利要求1所述的医疗装置，其中，所述传感器包括电开关。
3.如权利要求2所述的医疗装置，其中，所述电开关由按钮触发。
4.如权利要求1所述的医疗装置，其中，所述传感器包括光学传感器。
5.如权利要求1所述的医疗装置，其中，所述传感器包括磁传感器。
6.如权利要求1所述的医疗装置，其中，所述医疗装置还包括控制模块，所述控制模块连接到所述传感器以便接收低液体体积信号。
7.如权利要求1所述的医疗装置，其中，所述医疗装置还包括警示系统，所述警示系统用来警示所述储器的低液体体积状态。
8.如权利要求7所述的医疗装置，其中，所述警示系统传输光信号作为所述储器中的低液体体积的警示。
9.如权利要求7所述的医疗装置，其中，所述警示系统传输声音信号作为所述储器中的低液体体积的警示。
10.如权利要求7所述的医疗装置，其中，所述警示系统传输振动信号作为所述储器中的低液体体积的警示。
11.如权利要求7所述的医疗装置，其中，所述警示系统传输组合的光、声音和/或振动信号作为所述储器中的低液体体积的警示。
12.如权利要求1所述的医疗装置，其中，所述医疗装置还包括泵机构，所述泵机构用来将液体泵送出所述柔性储器。
13.一种医疗系统，所述医疗系统用来对使用者进行液体药物治疗，具有低体积传感器，所述医疗系统包括：
柔性储器，所述柔性储器用来包含液体；
泵机构，所述泵机构与所述柔性储器流体连接以便将液体从所述柔性储器中泵出；
传感器装置，所述传感器装置用来检测所述柔性储器内的流体体积；以及
控制模块，所述控制模块与所述传感器功能性地连接以便从所述传感器接收体积信号。
14.一种用来在系统中检测低液体体积并且向使用者告知清空时间的方法，所述系统包括：泵机构；柔性储器，所述柔性储器用来容纳待被供应的液体药物；刚性结构，所述刚性结构具有室以及与所述柔性储器流体连通的侧孔；柱塞，所述柱塞安装在所述室内并且被构造用来密封所述室的一侧；传感器，所述传感器用来检测所述柔性储器中的低液体体积；以及控制模块，所述控制模块与所述泵机构功能性地连接以便控制所述泵机构的操作，其中，当所述柱塞的内端部经过所述侧孔时，所述传感器被激励以传输指示所述柔性储器中的低液体体积的信号，所述方法包括以下步骤：
提供所述刚性结构，所述刚性结构具有连接到所述柔性储器的所述室；
将负压力施加至所述刚性结构的端部A；
从所述柔性储器移除流体；
检测所述柱塞与开关脱离接触的时刻；
基于当前流率以及所述室和导管的体积，计算估计的清空时间；
向使用者警示：体积是低的；以及
向使用者告知系统将用完液体的大致时间。
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US10814062B2 (en) 2020-10-27
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