CN110025485A - 智能小瓶适配器和方法 - Google Patents

智能小瓶适配器和方法 Download PDF

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CN110025485A
CN110025485A CN201910024896.XA CN201910024896A CN110025485A CN 110025485 A CN110025485 A CN 110025485A CN 201910024896 A CN201910024896 A CN 201910024896A CN 110025485 A CN110025485 A CN 110025485A
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bottle
vial adapter
drug
dosage
adapter
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杭天麒
U·西迪基
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Becton Dickinson and Co
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Becton Dickinson and Co
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Priority claimed from US16/051,249 external-priority patent/US10576211B2/en
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Abstract

本发明涉及智能小瓶适配器和方法。智能小瓶适配器能够测量从小瓶中抽取的药品的剂量、测量剂量捕获事件的时间、监测小瓶温度、测量小瓶受到的运动或扰动量、捕获可以提供与药品或从小瓶中抽取的剂量相关联的额外洞察的各种其它参数，以及将记录的信息传送到计算机、智能电话或其它设备上的配套应用。还公开并要求保护相关方法。

Description

智能小瓶适配器和方法
相关申请的交叉引用
本申请依据35U.S.C 119(e)要求于2018年1月12日提交的美国临时专利申请序列No.62/616,688的优先权，该申请被整体并入本文。
技术领域
本发明一般而言涉及小瓶适配器和剂量捕获系统。特别地，但不作为限制，本发明的实施例涉及智能小瓶适配器，该智能小瓶适配器不仅能够提供对药品小瓶的物理通路，而且还能够使用小瓶适配器内包含的电子部件执行剂量捕获、状态监测和信息报告功能。还公开并要求保护相关方法。
背景技术
一些类型的药品注射的有效施用，特别是在糖尿病患者使用的胰岛素的情况下，需要将药品保持在正确的储存条件下并且保持所有施用剂量的记录。虽然为家庭注射患者提供了教导，但大多数患者仍然发现每天都正确遵循指示是具有挑战性的。医疗保健人员可以在临床环境中记录与剂量相关的信息，但是存在与捕获该信息相关联的显著开销。测量和记录可影响药品安全性和功效的某些参数(诸如药品温度和正确混合)也很困难。
许多类型的药品在包含多个单独剂量的小瓶中提供。小瓶由橡胶隔膜密封，当将一剂药品从小瓶抽取到注射器中以准备注射时，该橡胶隔膜可以被注射器针头刺穿。替代针头，如果注射器具有不能刺穿隔膜的钝套管或鲁尔(Luer)尖端，那么可以使用小瓶适配器来使注射器接入小瓶。小瓶适配器具有刺穿隔膜的尖锐塑料钉(spike)或套管，以及可通过注射器的钝套管或鲁尔尖端接入的、通常为无针阀或预切口隔膜形式的流体端口。在小瓶适配器被安装在小瓶上之后，小瓶适配器可以留在原位，从而允许从小瓶中抽取多个剂量，而不用反复地穿透小瓶隔膜。
大多数小瓶适配器是完全机械性质的，仅提供小瓶和注射器之间的流体路径，以及小瓶的辅助密封。但是，小瓶适配器在小瓶上的物理存在以及其在小瓶和注射器之间的流体路径中的插入为小瓶适配器提供了执行附加功能的机会，诸如剂量捕获、状态监测和信息报告。本发明通过提供具有电子部件的小瓶适配器来利用这个机会，这些电子部件允许小瓶适配器执行这些和/或其它功能。还公开并要求保护相关方法。
发明内容
根据本发明的实施例，提供了一种小瓶适配器，该小瓶适配器不仅能够提供对药品小品的物理通路，而且还能够使用包含在小瓶适配器内的电子部件执行剂量捕获、状态监测和信息报告功能。这些功能可以包括测量从小瓶中抽取的剂量、测量剂量捕获事件的时间、监测小瓶温度、测量小瓶受到的运动或扰动量、捕获可以提供与药品或从小瓶中抽取的剂量相关联的附加洞察的各种其它参数，以及将记录的信息传送到计算机、智能电话或其它设备上的配套应用。
更具体而言，本发明的一个实施例涉及一种小瓶适配器，该小瓶适配器包括：具有第一端和第二端的壳体，第一端是开口的并且可附接到小瓶，第二端具有由可穿透的隔膜密封的流体端口；固定到壳体并与流体端口连通的小瓶通路套管，小瓶通路套管位于壳体的开口第一端内，用于穿透附接到壳体的小瓶的隔膜；以及包含在壳体内的电气部件，用于对包含在壳体中或从附接到壳体的小瓶抽取的药品进行至少一个剂量捕获、状态监测或信息报告功能。
在本发明的另一个实施例中，一种用于存储和使用包含在小瓶中的药品的方法包括：将适配器附接到小瓶，该适配器能够在药品被包含在小瓶中或通过适配器从小瓶中被抽取时对药品执行至少一个剂量捕获、状态监测或信息报告功能；以及使得小瓶适配器在药品被包含在小瓶中或通过适配器从小瓶中被抽取时对药品执行至少一个剂量捕获、药品监测或状态报告功能。
附图说明
通过以下结合附图的详细描述，将更容易地理解本发明的实施例的各方面和优点，其中：
图1是示出了药品小瓶、可附接到药品小瓶的智能小瓶适配器以及从智能小瓶适配器无线接收信息的移动设备的示意图；
图2是类似于图1的示意图，但是智能小瓶适配器附接到药品小瓶，注射器被定位成通过智能小瓶适配器从小瓶抽取剂量，并且移动设备没有被示出；
图3是智能小瓶适配器的详细截面图，该智能小瓶适配器被示出为与药品小瓶脱离；
图4是智能小瓶适配器内的电子部件的示意图，这些电子部件执行各种剂量捕获、状态监测和信息报告功能；
图5和6分别是当智能小瓶适配器在其睡眠和活动模式下操作时执行的操作的流程图；以及
图7-9是可以由移动设备产生的示例性屏幕显示，该移动设备被编程有与智能小瓶适配器相关联的软件应用。
具体实施方式
现在将详细参考在附图中示出的本发明的实施例，其中，相同的附图标记通篇表示相同的元件。本文描述和示出的实施例举例说明了本发明，但不限制本发明，并且附图不一定相对于彼此或相对于实际的物理实施例按比例绘制。此外，本领域技术人员将理解的是，本文使用的措辞和术语是出于描述的目的，而不应被视为限制。本文中“包括”、“包含”或“具有”及其变体的使用旨在涵盖此后列出的项目及其等同物以及附加项目。除非另有限制，否则本文中术语“连接”、“耦合”和“安装”及其变型被广泛使用并且包括直接和间接连接、耦合和安装。另外，术语“连接”和“耦合”及其变型不限于物理或机械连接或耦合。此外，诸如“向上”、“向下”、“底部”、“顶部”、“远侧”和“近侧”的术语是相对的，并且用于帮助图示，但不是限制性的。
图1和2是在本发明的一个实施例中采用的元件的整体组合的示意图。包含胰岛素或液体形式的另一种可注射药品的常规玻璃或塑料药品小瓶10由具有橡胶隔膜14的上盖12密封。与智能电话11或其它移动电子设备无线通信的智能小瓶适配器16可附接到小瓶10。小瓶适配器16具有圆柱形塑料壳体17和小瓶通路套管，该小瓶通路套管为具有尖锐尖端21的向下突出的中空塑料长钉(spike)18的形式。壳体17可附接在盖12上方，以提供到小瓶10的内部的流体通路，用于填充注射器19。
小瓶10和小瓶适配器16在图1中被示出为彼此分离，就像在小瓶适配器16被安装在小瓶10上之前或在它从小瓶10移除之后的情况那样。在图2中，小瓶10和小瓶适配器16被示出为彼此连接，就像它们在注射器填充期间那样。在连接状态下，长钉18以流体密封的方式穿过小瓶隔膜14以与小瓶10的内部连通。此外，小瓶适配器壳体17的整体下裙部20被容纳在小瓶盖12上方，并且裙部20的向内突出的稳定环22与盖12下方的环形槽24接合，以在小瓶10和小瓶适配器16之间提供可释放的卡扣或制动连接。小瓶适配器壳体17和裙部20的塑料材料具有足够的柔韧性和弹性，以允许小瓶10和小瓶适配器16之间可释放的卡扣或制动连接。
当小瓶10和小瓶适配器16如图2所示彼此连接时，注射器19可以经由小瓶适配器16被填充小瓶10中包含的药品的剂量，其方式大致与从小瓶直接填充注射器时的方式相同。初始地，连接的小瓶10和小瓶适配器16被倒置以允许液体药品通过长钉18的内腔从小瓶10流入到小瓶适配器16的壳体17内的圆柱形腔室26中。橡胶隔膜28密封腔室26以提供无菌环境并且防止在注射器填充期间空气或液体从腔室26泄漏(或进入到腔室26中)。一旦腔室26被填充，注射器19的柱塞30(其尚未与小瓶适配器16接合)就被拉回以用与从小瓶10撤出的药品剂量对应的空气量填充注射器筒32。然后将中空金属注射器针头36的尖锐尖端34推过小瓶适配器16的隔膜28，从而使中空针头36的内腔与包含液体药品的腔室26的内部流体连通。然后压下注射器19的柱塞30以将空气注入到腔室26中。
由于这时连接的小瓶10和小瓶适配器16仍然倒置，因此空气将立即移动到小瓶10中，并且腔室26将重新填充液体药品。如在传统的注射器填充过程中(即，没有小瓶适配器16)那样，将空气初始注入到小瓶10中补偿要从小瓶10移除的液体，从而防止当注射器19被填充时在小瓶10中形成真空。在空气注入之后，并且连接的小瓶10和小瓶适配器16仍然倒置的情况下，注射器19的柱塞30再次被拉回以将所需量的液体药品从腔室26抽取到注射器筒32中。当液体药品从腔室26中移除时，密封腔室26通过长钉18的内腔用来自小瓶10的等量液体药品重新填充。然后可以使用填充的注射器19将药品直接注射到患者体内，或通过PRN或其它类型的医疗端口直接注射到IV管线中。
图3是智能小瓶适配器16的详细截面图，该智能小瓶适配器被示出为与药品小瓶10脱离。如图所示，腔室26通过腔室26底部的开口38与长钉18的内腔36连通，从而允许空气和液体在腔室26和小瓶10的内部之间在任一方向自由移动。腔室26周围是包含各种电子部件42的环形腔室40，各种电子部件42允许智能小瓶适配器16执行其剂量捕获、状态监测和信息报告功能，如下文更详细讨论的。可以提供一个或多个通路门或板(未示出)以允许在智能瓶适配器16的初始制造期间将部件42安装在腔室40中，并且允许更换为这些部件供电的电池。较小的环形腔室44与长钉18的内腔36以环绕关系形成并且开口在长钉18的内腔36中。该腔室包含一个或多个电子流量传感器46，其能够测量腔室36内的液体流动，使得可以测量或计算在注射器填充期间通过内腔36的液体药品的体积。这允许智能小瓶适配器16执行其剂量捕获功能(即，确定从小瓶中抽取多少液体药品，并通过推断确定用户在特定时间或在特定间隔期间注射了多少液体药品)。流量传感器46优选地是在2016年8月2日提交的、并在2018年2月8日公布为美国专利申请公开No.2018/0036495的共同转让的美国专利申请序列No.15/226,638中详细公开类型的混合热飞行时间(TTOF)流量传感器，该申请通过引用被整体并入本文。但是，也可以使用其它类型的热和非热流量传感器。
在上述注射器填充过程的最后部分期间，当液体药品从倒置的小瓶适配器16的腔室26被抽取到注射器筒32中时，腔室26完全被液体药品填充。因此，从腔室26转移到注射器19中的液体药品量被通过长钉的内腔36从小瓶10抽取到腔室26中的等量液体药品替代。由于通过内腔36的流体流过流量传感器46，因此可以基于测量的流量和经过的时间来计算该量。计算出的量表示被转移到注射器19并由用户注射的药品剂量。
图3还示出了隔膜28不是实心的，而是可以被预先形成有切口48，切口48允许其被钝套管或鲁尔尖端穿透。当从小瓶10中抽取的药品打算通过无针阀或无针注射部位转移到IV管线而不是用针头注射到皮肤中时，这可能是优选的。在这种情况下，图2的注射器19设有鲁尔管件或钝套管来代替针头36。
图4是智能小瓶适配器内的电子部件42的示意图，电子部件42执行刚刚描述的剂量捕获功能，以及其它状态监测和信息报告功能。这些部件包括具有内部日时钟的微控制器50、先前描述的(一个或多个)流量传感器46、用于存储由微控制器50使用的编程和数据的存储器52、用于检测环境温度(并且通过推断确定小瓶10的温度及其内容物)的热传感器54、用于测量小瓶适配器16受到的运动或扰动量(并且通过推断确定小瓶10及其内容物)的加速度计56、用于与智能电话11或其它外部电子设备(诸如计算机或平板电脑)无线通信的蓝牙模块58、一个或多个视觉指示器60，诸如不同颜色的LED、一个或多个可听见的或触觉指示器62，诸如蜂鸣器(beeper)、蜂音器(buzzer)、扬声器或振动设备、一个或多个按钮64，以及感测小瓶适配器16与小瓶10的初始连接的微开关66。通常为可更换或可再充电DC电池和合适的电压调节电路系统形式的电源68向微控制器50和图4中需要电力的任何其它部件供电。
图5是当智能小瓶适配器16在其睡眠模式下操作时由微控制器50执行的操作的流程图。这是小瓶适配器16不被使用时的正常或默认操作模式。在步骤70中，微控制器50使用热传感器54记录环境温度并将记录的值存储在存储器52中。在步骤72中，微控制器50使用加速度计56记录小瓶适配器16可能经历的任何运动或搅动，并将记录的值存储在存储器52中。在步骤74，微控制器50记录一天中的当前时间并将记录的值与相关联的温度和运动读数一起存储在存储器52中。时间、温度和运动读数提供时间-温度和搅动数据，这些数据可以用于验证药品已经被存储在正确的温度下，即，在使用前已经被正确地混合，并且尚未过期。在步骤76中，或者当用户该接收一剂药品时，或者当检测到需要用户干预的情况时，使用视觉和/或可听见的指示器60、62发出声音警报。这样的情况可以包括在延长的时间段内过高或过低的温度、小瓶适配器16在足够长的时间量内没有移动，药品可能需要在使用之前搅拌或混合、或者小瓶10中的药品过期。当智能小瓶适配器16在其睡眠模式下操作时，以预定的采样频率(例如，每分钟一次)重复执行步骤70-76。
图6是当智能小瓶适配器16在其活动模式下操作时由微控制器50执行的操作的流程图。这是其中或者通过有意的用户输入(例如，按下其中一个按钮64)或者通过在小瓶适配器即将用于注射时诸如突然移动(由加速度计56检测)的感测条件来放置小瓶适配器16的操作模式。在步骤80中，通过将当前时间与预定开始时间进行比较来进行检查以确定药品是否已经过期。预定的开始时间可以例如通过用户输入(诸如按下另一个按钮64)或者通过微开关66感测小瓶适配器16与小瓶10的初始连接来定义。在步骤82和84中，进行检查以确定药品是否处于用于使用的正确温度以及(基于先前的搅拌历史)确定是否需要进一步混合药品。如果需要进一步混合，那么使用视觉和/或可听见的指示器60、62向用户发出警报，并且在步骤86中，进行检查以确认用户实际上已经提供充分的混合。然后用户使用先前描述的过程从小瓶适配器16填充注射器19。在步骤88中，微控制器50使用来自(一个或多个)流量传感器46的数据计算从腔室26抽取到注射器19中的剂量(补偿注射器内的任何死空间)。如果期望，可以使可听见的指示器62随着抽取接近预设体积而产生频率和/或强度增加的蜂鸣声。在步骤90中，将计算出的剂量体积与对应的温度、一天中的时间和任何其它期望信息一起存储在存储器52中。如果检测到有效蓝牙连接，那么使用蓝牙模块58将该剂量捕获数据发送到智能电话应用。然后，小瓶适配器重新进入睡眠模式，直到检测到下一个给药事件。每次通过小瓶适配器16从小瓶10抽取剂量时，重新进入图6的活动模式并重复步骤80-90。
图7-9是可以在智能电话11或其它移动设备上产生的示例性屏幕显示，该智能电话11或其它移动设备被编程有与智能小瓶适配器16相关联的软件应用。在所示示例中，所施用的药品是胰岛素，并且假定用户已将他或她的血糖测量值输入或导入到智能电话应用中以与来自小瓶适配器16的测得的剂量捕获数据一起处理。在图7中，显示的信息包括用户当天的统计数据，包括所施用的注射的数量100、在期望范围内的血糖测量值的百分比102、显示每次注射中施用的胰岛素量(例如，单位数量或以毫升计量的体积)的条形图104，以及显示随时间的血糖水平的线图106。在图8中，事件面板108被添加到显示器以将血糖测量值与注射事件配对。在图9中，显示了在7天内用户的统计信息。这些统计信息包括基于7天时段的注射和葡萄糖数据估计的A1c水平110、在7天时段内血糖测量的总数和每日平均值112、在范围中的数量116、构成7天总量的低于范围和高于范围的血糖测量，以及7天时段内血糖平衡、低血糖和高血糖的天数118。
在附图中未示出的替代实施例中，电动空气泵和空气过滤器可以被结合到小瓶适配器16的壳体17中，以在一剂液体药品从小瓶10被抽取到注射器19中之前迫使过滤空气进入到小瓶10中。这使得用户不需要使用注射器19手动执行该初始步骤。关于该实施例的附加细节可以在于2018年7月31日提交的共同转让的美国非临时申请序列No.16/051,249中找到，该申请通过引用被整体并入本文。
虽然仅示出和描述了本发明的几个实施例，但是本发明不限于所描述的实施例。相反，本领域技术人员将认识到的是，在不脱离本发明的范围的情况下，可以对这些实施例做出改变。另外，本文公开的任何实施例、特征和/或元件可以彼此组合以形成未具体公开的各种附加组合，只要组合的实施例、特征和/或元件不相互矛盾即可。所有这些变化和组合都被认为是在由所附权利要求及其等同物限定的本发明的范围内。

Claims (20)

1.一种小瓶适配器，包括：
具有第一端和第二端的壳体，第一端开口并能够附接到小瓶，第二端具有由可穿透的隔膜密封的流体端口；
固定到所述壳体并与所述流体端口连通的小瓶通道套管，所述小瓶通道套管位于所述壳体的开口第一端内，用于穿透附接到所述壳体的小瓶的隔膜；以及
包含在所述壳体内的电子部件，用于对包含在附接到所述壳体的小瓶中或从附接到所述壳体的小瓶中抽取的药品执行至少一个剂量捕获、状态监测或信息报告功能。
2.如权利要求1所述的小瓶适配器，其中所述剂量捕获、状态监测或信息报告功能选自包括以下的组：测量从小瓶抽取的药品量、测量从小瓶中抽取药品的时间、监测小瓶的温度、测量小瓶的运动、产生视觉指示、产生可听见的指示，以及将信息无线地传送到外部设备。
3.如权利要求1所述的小瓶适配器，其中包含在所述壳体内的电气部件包括流量传感器、热传感器、加速度计、微控制器、视觉指示器、可听见的指示器和蓝牙模块中的一个或多个。
4.如权利要求1所述的小瓶适配器，其中包含在所述壳体内的电气部件包括流量传感器，所述流量传感器被定位成与小瓶通路套管的内腔相邻，用于感测小瓶通路套管内的流体流动。
5.如权利要求4所述的小瓶适配器，其中所述流量传感器包括热飞行时间(TTOF)流量传感器。
6.如权利要求1所述的小瓶适配器，其中所述壳体包括流体端口和小瓶通路套管之间的内部流体腔室，所述内部腔室被隔膜密封并且与小瓶通路套管的内腔连通。
7.如权利要求6所述的小瓶适配器，其中所述电气部件被容纳在与内部流体腔室相邻的所述壳体的内腔中。
8.如权利要求7所述的小瓶适配器，其中所述内腔至少部分地围绕所述内部流体腔室。
9.如权利要求8所述的小瓶适配器，其中所述壳体和所述内部流体腔室各自为大致圆柱形，并且其中所述内腔为大致环形。
10.如权利要求1所述的小瓶适配器，其中所述隔膜包括能够由注射器针头穿透的固体隔膜。
11.如权利要求1所述的小瓶适配器，其中所述隔膜包括预切口隔膜，所述预切口隔膜能够由钝套管或鲁尔尖端穿透。
12.一种存储和使用小瓶中包含的药品的方法，包括：
将适配器附接到小瓶，所述适配器能够在药品被包含在小瓶中或通过适配器从小瓶中被抽取时对药品执行至少一个剂量捕获、状态监测或信息报告功能；
使得当药品被包含在小瓶中或通过适配器从小瓶中被抽取时所述小瓶适配器对药品执行至少一个剂量捕获、状态监测或信息报告功能。
13.如权利要求12所述的方法，其中所述剂量捕获、状态监测或信息报告功能选自包括以下的组：测量从小瓶抽取的药品量、测量从小瓶中抽取药品的时间、监测小瓶的温度、测量小瓶的运动、产生视觉指示、产生可听见的指示，以及将信息无线地传送到外部设备。
14.如权利要求12所述的方法，其中所述小瓶适配器包括流量传感器，并且其中所述功能包括通过使用所述流量传感器测量从小瓶中抽取的药品量而执行的剂量捕获功能。
15.如权利要求12所述的方法，其中所述小瓶适配器包括蓝牙模块，并且其中所述功能包括通过使用所述蓝牙模块将信息无线地传送到外部设备而执行的信息报告功能。
16.如权利要求15所述的方法，其中所述信息选自包括以下的组：剂量的量、剂量时间、小瓶温度和小瓶运动。
17.如权利要求15所述的方法，其中所述外部设备包括包含用于处理所述信息和提供用户输出的软件应用的计算机、智能电话或移动设备。
18.如权利要求17所述的方法，其中所述用户输出包括以下中的一个或多个的视觉或图形显示：(a)在预定时间段期间从小瓶中抽取的剂量的数量；(b)在预定时间段期间从小瓶中抽取的多个剂量中的每个剂量的剂量量；(c)与同期测得的生理数据配对的剂量事件；以及(d)基于剂量历史估计或预测的生理数据。
19.如权利要求18所述的方法，其中所述药品包括胰岛素，并且所述生理数据包括葡萄糖水平或A1c水平。
20.一种用于存储和使用包含在小瓶中的药品的方法，包括：
将如权利要求1所述的适配器附接到小瓶；
使得当药品被包含在小瓶中或通过适配器从小瓶中被抽取时小瓶适配器对药品执行至少一个剂量捕获、状态监测或信息报告功能。
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