CN111050822B - 检测注射期间施加的力的系统和方法 - Google Patents

检测注射期间施加的力的系统和方法 Download PDF

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CN111050822B
CN111050822B CN201880056116.3A CN201880056116A CN111050822B CN 111050822 B CN111050822 B CN 111050822B CN 201880056116 A CN201880056116 A CN 201880056116A CN 111050822 B CN111050822 B CN 111050822B
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force sensor
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C·里尼
B·罗伯茨
R·克拉格
R·佩蒂斯
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Abstract

医疗设备(100)包括胰岛素笔(102)、笔针(104)和力传感器(106)。该设备还包括微处理器(206)，以从力传感器(106)接收信号。听觉和/或视觉指示器(218、220)向用户提供反馈以鼓励适当的注射技术。该设备还可包括适配器组件，其包括传感器外壳(306)和在传感器外壳内的第一传感器(304)，以及转移针组件(308)，转移针组件提供用于笔针的连接部(310)并在笔针(312)和胰岛素笔(302)之间提供流体导管。第二力传感器(314)与胰岛素笔(302)的拇指按钮相关联。

Description

检测注射期间施加的力的系统和方法
技术领域
本文描述了一种用于检测和指示在药物注射期间施加到皮肤表面的力的系统和方法，以发展适当的注射技术并有助于准确的针插入深度。替代实施例结合了附加的传感器，以捕获在剂量给药期间施加到笔系统注射器按钮上的力。
背景技术
大多数控制糖尿病的患者使用注射器或笔式设备进行胰岛素给药，并依靠适当的注射技术和设备性能来稳定地输送至皮下组织空间。导致不适/疼痛的不适当技术可能会影响对治疗的依从性。导致全剂量递送不完全(渗漏)、皮内(浅层)或肌内(深层)递送以及注射到肥大性组织(lipohypertrophic)中的差的技术会导致血糖控制不一致，并导致短期和长期的与糖尿病相关的并发症。通常在着手治疗时才提供自我注射指导；因此，技术发展高度依赖患者，这可能由于心理或生理障碍而导致欠佳的方法。父母和照料者进行注射具有明显的缺点，因为不可能进行直接的感觉反馈。
当前的注射系统不能向用户提供有关适当施加力的信息。另外，在笔针毂、施加力和所需注射深度之间存在机械关系，从而使得对此类信息的需要成为必需。
发明内容
本发明的实施例为糖尿病和其他医学教育者、护理者和患者提供了一种实用工具，用于开发和维护适当的注射技术以促进在目标组织空间内的一致的针深度放置。根据示例性实施例的系统还提供了一种有意义的方式，来通过测量和理解所施加的插入/施加力来开发优化的注射设备(笔、自动注射器、笔针、注射器)。本发明的实施例提供了一种临床上有用的工具，该工具可以测量施加力并将其等同于系统功能、患者的可接受性、偏好和其他人为因素。最后，通过使用反馈控制回路，本发明的实施例可以通过在适当的力被施加到设备上时发出信号(例如，通过光、声音或振动指示器)来促进适当的使用，或者替代地，形成防止使用的闭锁，直到系统力在适当的范围内为止。
附图说明
将结合附图来描述本发明的实施例，其中：
图1A是本发明的第一实施例的分解图；
图1B是图1A的笔针毂上的力传感器的细节图；
图2是根据本发明的示例性实施例的信号处理电路的框图；
图3示出了具有两个力传感器的本发明的另一实施例；和
图4A-4I是随时间变化的力的图，示出了拇指和皮肤施加的力。
在整个附图中，相似的附图标记应被理解为指代相似的元件、特征和结构。
具体实施方式
现在将参考附图描述本发明的示例性实施例。应当理解，本文描述的实施例仅是示例性的，并且用于向本领域普通技术人员说明如何制作和使用本发明的实施例，但是可以对本文描述的实施例进行各种改变和修改而不会脱离本发明的范围和精神。
如图1A和图1B所示，本发明的第一实施例是一种设备100，其包括具有笔针104和力传感器106的胰岛素笔102。力传感器106优选地布置在笔针104的毂面(hub face)108上。当胰岛素笔被使用时，笔针104被压在皮肤表面上，并且力传感器106将物理刺激的变化转换为电信号。优选地通过信号调节电路等来调节电信号并将其转换为机械量，例如力值，并且将其传递到微控制器，其中力值可以用作向算法或处理的输入。
图2示出了根据本发明实施例的处理电路的示例性框图。优选地，处理电路被物理地结合在图1A和图1B所示的设备100内，但是本领域的普通技术人员将容易理解，这里描述的处理电路的一个或多个组件可以位于单独的设备中。图2的处理电路200优选地包括力传感器106、用于放大从力传感器106接收的原始信号的信号放大器202、模数转换器204以及接收来自力传感器的表示力值的转换后的数字信号的微控制器206。处理电路还优选地包括电源208，该电源优选地包括DC-DC转换器210并用于从硬币电池等向微控制器206供电。电源208还优选地包括可再充电电池(例如LiPO电池(未示出))以及相关联的电压调节器212和充电管理控制器214。优选地，处理电路还包括用于将处理电路200连接到其他设备并用于给可再充电电池充电的USB端口216等。处理电路200优选地还包括用于向用户输出指示的视觉指示器(诸如LED指示器218)和听觉指示器220。
微控制器206优选地包括存储器222或与存储器222相关联，该存储器包含用于执行的程序指令。可以有利地提供程序指令，以基于从力传感器接收的数据来遵循一组规则，并基于所测量的施加力通过视觉和/或听觉指示向护理人员提供反馈。
在图3中示出了第二示例性实施例。第二实施例类似于第一实施例，只是设备300包括两个负载传感器而不是一个负载传感器。该实施例包括可以被结合到任何标准胰岛素笔302的端部上的适配器组件300。组件300包括力传感器304(诸如甜甜圈形测力传感器)、传感器壳体306和转移针组件308。适配器组件300优选地被螺纹固定到标准胰岛素笔上，并提供用于笔针312的连接部310。力传感器304测量在注射期间施加到皮肤表面的力。设备300还包括与拇指按钮308相关联的负载传感器314，以测量通过笔系统施加以输送药物的力。处理电路和电源可以被合并到适配器组件中，或者可以向容纳这些组件的外部设备提供连接。以这种方式，可以测量注射力，并将反馈提供给任何标准胰岛素笔的使用者。
图4A-图4I示出了从根据第二实施例的设备记录的数据。如图所示，设备中装有两个负载传感器，一个在拇指按钮上，一个在连接器适配器内。在图中绘制了两个传感器随时间测量的力。如图所示，对于该特定注射，施加到皮肤上的力被立即测量并被保持在半稳定水平，然后测量将注射液从笔系统传送到注射部位所需的拇指力。流体输送完成后，所施加的拇指力停止。该设备在流体输送后保持在皮肤表面5-10秒，以使得从注射部位的泄漏最小化。在注射过程结束时，将胰岛素笔被从使用者身上撤回。
如本领域普通技术人员将理解的，通过记录在注射期间胰岛素笔或其组件中存在的力，可以进行注射的分析，并将反馈导出并提供给用户。例如，这样的数据将表明用户没有使用足够的力，或者在按下拇指按钮后没有将胰岛素笔保持在注射部位达足够长的时间。
该设备的一个优选实施例具有集成在笔针毂面中或笔针毂面上的力传感器。在笔针毂内提供电连接，以向力传感器提供电源，并获取力信号以进行进一步处理。处理电路和电源优选地设置在笔系统主体内部。
第二实施例包括集成在笔针毂中或笔针毂上的力传感器，其具有柔性电路引线，该柔性电路引线适于连接至在胰岛素笔外部的单独壳体。电源和处理电路优选地位于外壳内。外壳适于安装在胰岛素笔上作为附加设备。
如本领域的普通技术人员将理解的，本文描述的任何实施例可以包括电路组件，该电路组件使得能够通过有线或无线介质将数据传输到诸如CPU、平板电脑、电话和/或手表的耐用介质，该耐用介质具有关联的软件应用，用于数据可视化和存储。
本领域普通技术人员还将理解，尽管已经结合笔针设备描述了本发明的实施例，但是需要与皮肤或其他生理表面直接接触的任何合适的注射或药物输送系统都可以利用本文概述的原理和特征。
最后，本领域普通技术人员将理解，在不脱离权利要求及其等同物所限定的本发明的范围的情况下，可以对所公开的实施例进行修改，并且不同实施例和权利要求的特征可以与每个特征相结合，只要它们彼此不矛盾即可。

Claims (12)

1.一种医疗设备，包括：
带有与其附接的笔针的胰岛素笔，
布置在笔针的毂面上的第一力传感器，
布置在胰岛素笔的拇指按钮上的第二力传感器，
从第一力传感器和第二力传感器接收信号的微控制器；和
由微控制器控制的听觉指示器和视觉指示器中的至少一个，
所述医疗设备被配置为随时间记录由第一力传感器和第二力传感器测量的力，并且
所述医疗设备还被配置为分析胰岛素的注射并且结合由第一力传感器测量的力和由第二力传感器测量的力两者来提供反馈。
2.根据权利要求1所述的医疗设备，还包括：放大器，用于放大力传感器的模拟信号；以及模数转换器，用于将经放大的信号转换为数字信号。
3.根据权利要求1所述的医疗设备，还包括向微控制器供电的电源。
4.根据权利要求3所述的医疗设备，还包括：电压调节器，以调节来自电源的电力；以及充电管理控制器，以调节电池的充电。
5.根据权利要求4所述的医疗设备，其中，电池是可充电电池。
6.根据权利要求1所述的医疗设备，还包括USB端口，USB端口用于将微控制器连接到外部设备，并且用于接收电力以对电池充电。
7.根据权利要求1所述的医疗设备，还包括：存储器，其包含程序指令，程序指令基于从力传感器接收到的数据来遵循规则，并且基于由力传感器测量的所测量的施加力经由至少一个指示器提供反馈。
8.一种医疗设备，包括：
用于在笔针附接部分处接收笔针的胰岛素笔；
适配器组件，附接到胰岛素笔的附接部分，并且在适配器组件的相对端上接收笔针；
适配器组件包括第一力传感器、传感器壳体和转移针组件，该转移针组件在笔针和胰岛素笔之间提供流体导管；
与胰岛素笔的拇指按钮相关联的第二力传感器，
所述医疗设备被配置为随时间分别记录由第一力传感器和第二力传感器测量的力，并且
所述医疗设备还被配置为分析胰岛素的注射并且结合由第一力传感器测量的力和由第二力传感器测量的力两者来提供反馈。
9.根据权利要求8所述的医疗设备，还包括微处理器，该微处理器从第一力传感器和第二力传感器接收信号。
10.根据权利要求8所述的医疗设备，还包括电源。
11.根据权利要求8所述的医疗设备，其中，第一力传感器测量笔针对皮肤的力，并且第二力传感器测量施加到拇指按钮的力。
12.根据权利要求8所述的医疗设备，还包括听觉指示器和视觉指示器中的至少一个。
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