CN211301537U - 剂量测量设备 - Google Patents

剂量测量设备 Download PDF

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CN211301537U
CN211301537U CN201921526246.7U CN201921526246U CN211301537U CN 211301537 U CN211301537 U CN 211301537U CN 201921526246 U CN201921526246 U CN 201921526246U CN 211301537 U CN211301537 U CN 211301537U
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dose
sensor
pen
pen injector
static portion
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A·利马耶
J·加特纳
P·彭斯德莱昂
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Becton Dickinson and Co
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Abstract

本申请涉及剂量测量设备。提供了用于注射笔(106)的两件式盖(100)。盖包括保留在笔式注射器(106)上的静态部分(102)和可移除部分(104)。静态部分(102)包括剂量传感器(126)，其用于感测笔式注射器(106)的贮存器(114)内的柱塞(118)的移动。基于检测到的柱塞移动来计算所递送的剂量。

Description

剂量测量设备
技术领域
本实用新型一般而言涉及药物剂量测量设备。更具体而言，本实用新型涉及用于笔式注射器的盖子，其在注射期间直接检测柱塞移动并测量剂量。
背景技术
糖尿病是特征为高血糖水平的一组疾病，由于胰岛素产生的缺陷、胰岛素作用或两者引起。糖尿病会导致严重的健康并发症和过早死亡，但糖尿病患者可以使用众所周知的产品来帮助控制疾病并降低并发症的风险。
糖尿病患者的治疗选择包括专门饮食、口服药物和/或胰岛素治疗。糖尿病治疗的主要目标是控制患者的血糖(糖)水平，以便增加无并发症生命的机会。但是，在平衡其它生活需求和环境的同时，实现良好的糖尿病管理并不总是容易的。
传统上，笔式注射器为需要胰岛素治疗的人提供了方便、便携的注射胰岛素的手段。但是，为了让经由胰岛素笔进行糖尿病管理成功，重要的是患者按照其医疗提供者的指示施用药物剂量并且还适当地给予自己注射。胰岛素笔应当在注射后立即由患者保持一段时间，以便胰岛素被身体适当地吸收。医疗保健提供者还希望准确记录注射量和时间，以帮助他们评估患者的糖尿病管理。目前，这些功能是手动执行的。指导患者注射药物并计数到一定数量，例如10，以确保整个剂量的药物已被吸收到皮肤中并递送给患者。类似地，在注射后，预期患者记录注射的胰岛素量和注射时间。现有的笔式注射器很多，但不能帮助用户使用正确的注射技术，也不会记录或传达剂量记录给医疗保健提供者。因而，需要设备来帮助用户正确注射胰岛素并记录成功或不成功的剂量并将该信息传达给用户及其医疗保健提供者。
实用新型内容
本实用新型的说明性实施例的一个方面是基本上解决上述和其它问题，并提供用于注射笔的更换盖。更换盖包括在注射期间保留在注射笔上的静态部分，以及在不使用时覆盖注射笔远端并且被移除以供使用的可移除盖。盖的静态部分包括电子器件和传感器以检测柱塞在药瓶内的位置和移动，并基于检测到的移动记录剂量。
本实用新型的附加和/或其它方面和优点将在下面的描述中阐述，或者将从描述中清晰，或者可以通过本实用新型的实践来学习。本实用新型可以包括具有上述方面中的一个或多个和/或特征中的一个或多个及其组合的方法或装置或系统。本实用新型可以包括例如所附权利要求中所述的上述方面的特征中的一个或多个和/或组合。
附图说明
当结合附图阅读时，从以下详细描述中将更容易理解本实用新型的说明性实施例的各种目的、优点和新颖特征，其中：
图1-3是本实用新型的示例性实施例的侧视图；
图4是本实用新型的示例性实施例的框图；
图5A及图5B是根据本实用新型的示例性实施例的方法的流程图；
图6-8是根据本实用新型的示例性实施例的移动设备上的用户界面的屏幕截图；
图9是本实用新型的示例性实施例的系统图；
图10是本实用新型的示例性实施例的透视图；
图11图示了根据本实用新型的示例性实施例的盖的正视图和截面视图；以及
图12图示了根据本实用新型的示例性实施例的盖的侧视图和截面视图。
贯穿整个附图，相同的标号将被理解为指相同的特征、元件和结构。
具体实施方式
如本领域技术人员将认识到的，存在许多方式来执行根据本文所公开的实施例的用于笔式注射器的智能盖的示例、改进和布置。虽然将参考附图和以下描述中描绘的说明性实施例，但是本文公开的实施例并不意味着穷举由所公开的实用新型所涵盖的各种替代设计和实施例，并且本领域技术人员将容易认识到，在不脱离本实用新型的情况下，可以进行各种修改，并且可以进行各种组合。
如图1中所示，本实用新型的示例性实施例包括用于笔式注射器的两件式盖100。盖100包括静态部分102和可移除部分104。盖 100可以安装在笔式注射器106上。笔式注射器组件包括笔式注射器主体108、拇指按钮110、一次性笔式针112和贮存器室114。贮存器室114还包括窗口116，通过该窗口可以看到柱塞118和保留在安装在贮存器室114中的贮存器中的药物流体120。
图2图示了安装到笔式注射器106上的盖100。图3图示了盖 100的可移除部分104被移除以暴露笔式针112并允许注射。可移除部分104优选地通过摩擦配合、卡扣配合、螺纹连接或任何其它合适的机构与静态部分102连接和断开。
在本实用新型的示例性实施例中，盖100的静态部分102包括三个传感器。存在盖传感器122以感测盖100的可移除部分104的存在或不存在。还存在接近传感器124，其感测笔式注射器在注射期间是否保持压靠在用户的皮肤上。第三个传感器是剂量传感器126，其结合到盖100的静态部分102中，并且将在下面进一步详细描述。剂量传感器126有利地或者光学地或者通过任何其它合适的手段感测贮存器中的柱塞位置和/或剩余流体。因为盖100的静态部分102在注射期间保持在笔式注射器106上，所以剂量传感器126可以在注射期间实时地跟踪柱塞118的移动。
如图3所示的示例性实施例中所示，盖100的可移除部分104的尺寸可以设计为容纳笔式针112。在其它实施例中，盖100的可移除部分104的尺寸可以设计为不容纳笔式针，从而在移除可移除部分 104之后并且在更换可移除部分104之前将笔式针与笔式注射器106 附连和分离。
图4是上述盖100和笔式注射器106的框图。盖100包括静态盖 102和可移除笔式针盖104。如上所述，静态盖102容纳盖传感器 122、接近传感器124和剂量传感器126。静态盖102还容纳用于与诸如移动单元之类的远程设备通信的无线通信单元128，如下面将进一步详细讨论的。静态盖容纳电源电池130和微控制器132，微控制器132用于接收来自传感器的信号并控制经由无线控制器128与远程设备的通信，以及其它功能。静态盖102优选地包括机械连接特征 134，以将静态盖连接到笔式注射器106的主体108。
图5A及图5B图示了与笔式注射器106结合使用盖100的示例性方法。在步骤500处，将可移除笔式针盖104从注射器106移除。在步骤502处，盖检测器122检测到可移除盖已被移除，并且唤醒静态盖102，静态盖102开启，并且优选地在步骤504处，静态盖102 建立与远程设备(诸如移动电话等)的联系。在步骤506处，用户对笔上的隔膜进行消毒。在步骤508处，笔式针112附连到笔式注射器主体108。在步骤510处，用户拨打预注剂量，该预注剂量通常是两个单位。在步骤512处，用户分配预注剂量。在步骤514处，用户确定预注是否成功。如果预注不成功，那么该方法在步骤516处继续并且在步骤518处将预注错误记入日志并且在连接的移动设备上向用户显示检查针是否堵塞的警报。如果预注成功，那么该方法继续到步骤 520，并且在步骤522处设备记录成功的预注步骤作为事件并将其记入日志，并在移动设备上显示“已预注笔式针，准备好注射”。接下来，用户在步骤524处拨打要注射的剂量。在步骤526处，将笔式针插入患者的皮肤中。在步骤528处，接近传感器124检测到笔式针已插入皮肤并在所连接的移动设备的显示器上显示“准备好注射”。在步骤530处，用户通过拇指按压按钮来激活笔以分配剂量，并且在步骤532处，剂量传感器126感测剂量已被激活，并且显示器优选地针对较大剂量显示倒计时计时器至少10秒或更长时间。剂量传感器 126优选地感测并记录与柱塞移动对应的移动数据，并记录基于柱塞移动计算的剂量。在步骤534处，设备确定是否成功递送了完整剂量。如果未递送完整剂量，那么该方法继续到步骤536，并且在步骤538 处，剂量递送的错误被记录在电子日志中并显示“未递送目标剂量”。如果剂量被成功递送，那么该方法继续到步骤540，并且在步骤542 处，设备记录成功的剂量递送并在移动设备的显示器上显示“已递送 x单位的剂量”。在步骤544处，用户将笔式针从注射器分离。在步骤546处，用户将笔式针盖104更换到笔式注射器106上并将其存储，直到下次使用。优选地，此时，在步骤548处，静态盖102的电子器件识别出与移动设备的联系已断开并记录该事件。
图6-8是根据本实用新型的示例性实施例的移动设备600上的示例性用户界面显示。本领域普通技术人员应当认识到的是，本文描述的消息仅仅是示例性的，并且可以替换传达类似含义的替代消息或符号。图6图示了当预注步骤不成功时使用的示例性显示。该显示读作“警告！！预注步骤不成功.检查针是否堵塞.必要时更换针.重复预注步骤”。图7图示了当预注步骤成功时使用的示例性显示。该显示读作“已分配两个单位的剂量.笔式针已预注.准备好注射.请拨打目标剂量”。图8图示了在注射期间使用的示例性显示。该显示示出了倒计时定时器，其优选地从十秒倒计时，在此期间用户应当保持将笔式注射器压在皮肤上。接近传感器124确认笔式注射器106没有被过早地移除，并且如果笔式注射器106被过早地移除则造成错误。
图9图示了根据本实用新型的示例性实施例的系统900。系统 900包括具有基本上如上所述的盖100的笔式注射器106、移动设备 904以及远程服务器或云存储装置906。盖100的剂量传感器126和接近传感器124优选地经由无线通信链路908将信号发送到移动设备 904。以这种方式，移动设备可以记录并分析利用附加设备和笔式注射器902发生的事件，并且附加地在移动设备904的显示器910上向用户提供反馈。移动设备904进而有利地具有到远程服务器906的无线通信链路912，远程服务器906可以是云存储装置等。移动设备904优选地将信息发送到远程服务器，使得信息可以由医疗保健提供者或其他相关方访问。发送到远程服务器906的信息可以是由移动设备904从笔式注射器106和盖100接收的所有数据，或者优选地可以是信息的子集，或者由移动设备904接收并根据安装在移动设备904中的程序指令进行分析的信息的结果和/或摘要。
图10是本实用新型的实施例的透视图。如图所示，盖100包括电子器件壳体140。电子器件壳体140容纳电子器件板142，如图12 的侧视图中所示。盖100还包括锁定螺母144，以将盖100固定到笔式注射器106。图11是盖100的前视图，示出了夹头或卡盘夹紧机构146，其与锁定螺母144一起工作以将盖100固定到笔式注射器 106。图11还图示了盖100的内表面上的传感器阵列148，以在注射期间感测柱塞位置和移动。应当认识到的是，传感器阵列可以是任何合适的传感器，包括布置在笔式注射器106和药瓶的同一侧上的光学反射发射器和传感器，或布置在药瓶的相对侧上的透射发射器和传感器。
图10-12还图示了可移除部分104的示例，该可移除部分104的尺寸被设计为使得笔式针112不被容纳在可移除部分104内，而可移除部分104附连到静态部分102。
虽然上面仅详细描述了本实用新型的几个说明性实施例，但是本领域技术人员将容易认识到的是，在说明性实施例中有可能进行许多修改，并且说明性实施例的各种组合是可能的，而不实质上脱离本实用新型的新颖教导和优点。因而，所有这些修改都意图包括在本实用新型的范围内。

Claims (7)

1.一种剂量测量设备(100)，用于与笔式注射器(106)一起使用，其特征在于，包括：
附连到笔式注射器的主体的静态部分(102)，以及附连到静态部分(102)并且可从静态部分(102)移除以暴露笔式注射器(106)的笔式针(112)的可移除部分(104)；
静态部分(102)包括用于感测可移除部分(104)何时从静态部分(102)被移除的盖传感器(122)、用于感测笔式注射器(106)何时与用户相邻的接近传感器(124)，以及用于在注射期间检测柱塞(118)在贮存器室(114)内的移动的剂量传感器(126)。
2.如权利要求1所述的剂量测量设备，其特征在于静态部分还包括将剂量数据传送到远程设备的无线通信单元。
3.如权利要求2所述的剂量测量设备，其特征在于远程设备是移动电话。
4.如权利要求1所述的剂量测量设备，其特征在于，还包括微控制器，微控制器接收来自接近传感器、盖传感器和剂量传感器的输入信号。
5.如权利要求4所述的剂量测量设备，其特征在于，微控制器还适于根据接收到的信号确定剂量信息，并将剂量信息发送到远程设备。
6.如权利要求1所述的剂量测量设备，其特征在于，剂量传感器包括光源和至少一个光电检测器，所述光电检测器接收从光源发送并通过贮存器室的光。
7.如权利要求1所述的剂量测量设备，其特征在于，剂量传感器包括光源和至少一个光电检测器，所述光电检测器接收从光源发送并从柱塞反射的光。
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