CN106716085B - 用于药物配制的增强台板 - Google Patents

用于药物配制的增强台板 Download PDF

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CN106716085B
CN106716085B CN201580049691.7A CN201580049691A CN106716085B CN 106716085 B CN106716085 B CN 106716085B CN 201580049691 A CN201580049691 A CN 201580049691A CN 106716085 B CN106716085 B CN 106716085B
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C·森德曼
E·K·维特
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Becton Dickinson and Co
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Abstract

用于制备和管理例如化疗化合物的处方液体药物化合物的系统，包括具有台板的秤。所述秤联通用来显示其输出的用户显示器。图像采集设备具有捕捉置于台板上的物体最少一个图像的视场，图像采集设备联通用户显示器来显示捕捉到的图像。台板可以包括标识图像采集设备的部分视场的视觉标识符。台板还可以包括增粘剂或吸收性材料。台板可以由透光材料制成。

Description

用于药物配制的增强台板
相关申请的交叉引用
本申请要求以下美国临时申请的优先权，由此各美国临时申请的全部内容通过引用并入本文：于2014年9月8日提交的申请序列号为No.62/047,325、名为“AutomatedVisual DocumentationFeature withMinimal User Input”的美国临时申请，于2014年10月29日提交的申请序列号为No.62/072,160、名为“Enhanced Pharmacist Review Modulefor a Systemfor Preparing a Pharmaceutical Compound”的美国临时申请，于2014年10月29日提交的申请序列号为No.62/072,054、名为“Aerodynamically StreamlinedEnclosure for Input Devices of a Medication Preparation System”的美国临时申请，于2014年11月11日提交的申请序列号为No.62/078,067、名为“AerodynamicallyStreamlined Enclosure for Input Devices of a Medication Preparation System”的美国临时申请，于2014年11月11日提交的申请序列号为No.62/077,968、名为“EnhancedPlaten for Pharmaceutical Compounding”的美国临时申请。
发明背景
技术领域
本发明主要涉及一种秤系统和一种制备药物组合物的方法，例如化疗化合物，具体涉及一种具有增强台板的配比系统。
背景技术
在药房中许多涉及药品制备的技术职责可以由药剂学技术员或者执业护士来进行，然后由远程的药剂师进行审核。目前已研发出利用算法核对重量分析的信息的系统来确认药品的制备具有适当的浓度。秤可在重量方面用于保证整个配制过程使用了适当的药品浓度。在一些待制备的药品是无菌复合药物的实施案例中，例如化疗药品或者其他细胞毒性药品，这些药品的制备常在流罩中实施。在这些配置中，秤通常设置在流罩内。由于流罩内的空间通常非常珍贵，因此需要占用流罩内最小空间的增强安全特性的秤。
此外，化疗药品或其他细胞毒性药品的制备要求药剂学技术员穿戴保护装置，这些保护装置通常庞大且笨重。因此，需要一种更简单使用和更高安全特性的改良秤，以减少用户暴露在药品制备过程的有毒成分中的风险。
发明内容
根据本发明的一个方面，用于无菌配制的系统包括一个带台板的秤。所述秤联通有显示其输出的用户显示器。系统还包括具有捕捉置于台板上的物体最少一个图像的视场的图像采集设备，同时图像采集设备联通用户显示器来显示捕捉到的图像。台板包括标识图像采集设备的部分视场的视觉标识符。
在一些配置中，图像采集设备放置在台板上方。秤可以包括支撑台板的基部，图像采集设备可以封装在外壳内，外壳由连接秤基部的支撑臂支撑。外壳可以包括条形码扫描器，该条形码扫描器具有检测置于台板上物体的条形码的传感器。可选地，台板的视觉标识符包括十字形凹部。在一些配置中，台板内限定有多条凹槽。在其他配置中，台板的表面伸出多个突起。可选地，台板可配置成单次使用后即进行处理。在进一步的配置中，系统还包括布置在台板至少部分顶面上的盖子，其中该盖子配置成单次使用后即进行处理。
根据本发明的另一实施例，用于无菌配制的系统包括秤，该秤具有基部和由所述基部支撑的一次性台板。秤联通显示其输出的用户显示器。系统还包括图像采集设备，用于捕捉置于台板上的物体的至少一个图像，所述图像捕采集设备联通用户显示器以显示捕捉到的图像。一次性台板可以包括吸收性材料以吸收在无菌配制过程中使用的液体。
在一些配置中，台板在其中限定有接收井，吸收性材料设置在接收井内。可选地，所述台板包括增粘剂。
根据本发明的另一实施例，用于无菌配制的秤包括基部和由基部支撑的台板，所述台板上设有涂层。所述涂层提供了对液体接触涂层做出响应的可视标识。
在一些配置中，至少部分涂层对细胞毒素物质接触涂层做出响应而改变颜色。
根据本发明的另一实施例，用于无菌配制的秤包括内置有照射源的基部和由基部支撑的台板。台板包括透光部以允许照射源照亮置于台板上的物体。
根据本发明的另一实施例，用于无菌配制的秤包括内置有条形码扫描器的基部和由基部支撑的台板。所述台板包括透光部以允许条形码扫描器扫描置于台板上的物体的条形码。
根据本发明进一步的实施例，用于无菌配制的系统包括带有台板的秤。所述秤联通显示其输出的用户显示器。系统还包括图像采集设备，图像采集设备具有捕捉置于台板上的物体最少一个图像的视场。图像采集设备联通用户显示器以显示捕捉到的图像。台板包括独特标识符，独特标识符向用户指示台板是否已在秤上使用了一定的使用时间。
可选地，系统要求在确定台板的使用时间处于依从性参数的范围内之前，禁止用户进行无菌配制程序。
本发明的这些和其他特征和特性、操作方法、结构相关元件和部件组合的功能、以及节约制造成本，将在分别构成申请文件部分的下文说明书、所附权利要求和附图基础上记载得更清楚，其中相同的附图标记表示各个附图中相同的部件。然而需特别指出的是，附图仅为举例和详细描述，并非对本发明的限制。在说明书和权利要求中的单数形式“一”和“该”除了本文中另有清楚指明外，包括复数指代。
附图说明
图1是本发明的实施例的用于制备药物化合物的药物制备系统的立体图。
图2是本发明的实施例的图1所示的药物制备系统在具有用户界面的层流罩内的立体图。
图3是本发明的实施例的图1所示的药物制备系统的部分爆炸立体图。
图4是本发明的实施例的秤台板的立体图。
图5是本发明的实施例的图4所示的秤台板的俯视图。
图6是本发明的实施例的图4所示的秤台板沿图5所示的D-D线截得的凹槽剖视图。
具体实施方式
为了后文的描述，术语“上部”、“下部”、“右侧”、“左侧”、“竖直”、“水平”、“顶部”、“底部”、“横向”、“纵向”及其派生词应按照其在附图中的定位来关联本发明。然而，应当理解，本发明除明确说明相反外，可以采取多种可选变形。还应当理解在所附附图和下文说明书中所举例的具体装置，仅为本发明的示范性实施例。因此，在本文实施例中涉及的具体尺寸和其他物理特性不视为限制。
参照图1-2的药物制备系统，附图标记一般为1，协助药剂师或非药剂师技术员用一种或多种处方药物化合物制备注射器、瓶药、或静脉注射(IV)袋。药物制备系统可有效连接用户界面3，其包括带处理器和存储内存的计算机、显示器5、用户输入装置7，诸如键盘、鼠标等。带秤输出界面11的秤9可以有效连接用户界面3。
在一实施例中，条形码扫描器13可以有效连接用户界面3和秤9中至少一个，以使条形码扫描器13可以扫描置于秤9部分上面的带条形码的药瓶。在另一实施例中，图像采集设备15可以有效连接用户界面3和秤9中至少一个，以使图像采集设备15可以拍摄物品的照片，例如置于秤9部分上面的药瓶、IV袋或注射器。在一实施例中，为药品制备过程存档和/或随后的审核，图像采集设备15在整个药品制备过程中可以捕捉置于秤9部分上面的物品的多个静止图像或者动态图像。
在另一实施例中，至少条形码扫描器13和图像采集设备15中一个至少部分地封装在外壳17内。在一些配置中，外壳17可以全部封装条形码扫描器13和图像采集设备15。可选地，外壳17可以仅仅包括条形码扫描器13和图像采集设备15中的一个。在一配置中，条形码扫描器13可以设置在外壳17内，以使所述条形码扫描器13无须用户更多的操作就可轻易地扫描置于秤9部分上面的物品的条形码。在另一实施例中，图像采集设备15可以设置在外壳17内，以使图像采集设备无须用户更多的操作就可轻易地捕捉置于秤9部分上面的物品的图像。
特定参照图3，外壳17可以由上部17A和下部17B接合形成来实现最小化表面干扰，使得例如细菌或其他病原体的污染物的表面附着最小化。在一实施例中，外壳17的制造依照USP 797。光学镜片6、7可以与外壳17配合以进一步保证依照USP797。在一配置中，光学镜片6可以与外壳17配合来与图像采集设备15光通信。在另一配置中，光学镜片7与外壳17配合来与条形码扫描器13光通信。
在一配置中，条形码扫描器13可以设置在外壳17内，以使条形码扫描器13具有扫描器，该扫描器无须用户更多的操作就可补偿即时扫描置于秤部分上面的物品的条形码。这样的配置可避免意外扫描。如图3所示，条形码扫描器13可以设置成使传感器相对于秤的台板31成角度，例如通过安装支架18成45°角度。在这样的配置中，用户必须主动将待扫描的物体放置到条形码扫描器13的传感器的范围内。在另一配置中，图像采集设备15可以设置在外壳17内，以使图像采集设备无须用户更多的操作就可轻易地捕捉置于秤9部分上面的物品的图像。
外壳17可以设置在秤9部分的上方，例如由支撑臂19支撑。如图2所示，药物制备系统1可以设置在层流罩25内，该层流罩25具有进气源23和排气口27，以在层流罩25的内腔29制造空气的层流。外壳17的外表面21可以具有最能减少层流罩25内空气流扰乱的形状和/或轮廓。
再次参照图1-3，秤9可以包括基部43，基部43支撑着位于其上方的台板31。秤9可以实现为当物体放置在其上面时检测质量或重量变化的任何合适的装置。因此，秤9可以简单地配置为当物体质量或重量比预设阀值大或小时发送信号的装置，或者是精准读取置于其上的物体的重量的高精度秤。可选地，基部43容纳有测量置于台板31上的物体应变的应变式称重传感器和将施加在台板31上的力转变成电信号的力传感器，例如称重传感器，电信号可转送至秤输出界面11。基部43支撑作为秤9部分称重面的台板31，台板31给技术员提供将由图像采集设备15捕捉的图像的中心或其他所需部分的可视指示，例如交叉凹部35。这让技术员在图像采集设备15的视场内正确地放置与药品制备相关的药物37和相关用品，例如图像采集设备封装在设置于秤9的台板31上方的外壳17内。在一配置中，如图4-6所示，台板31的上表面41可以限定有多条凹槽39和/或从台板31表面伸出多个突起，来摩擦地限制台板31的上表面41上的与药品制备相关的药物37和相关用品。在另一配置中，台板31的上表面41包括增粘剂或其他提高表面摩擦来类似地限制台板31的上表面41上的与药品制备相关的药物37的药品和相关用品。凹槽39和/或突起可轻易地给用户指示台板31的中心，台板31的中心可以布置成与图像采集设备15的视场中心重合。
多条凹槽39和/或从台板31表面伸出的突起可以配置成在配制程序中抑制任何液体材料从台板31上表面意外溢出。在能够采用适当的处置技术之前，多条凹槽39可以形成接收井47，用于在限定的区域内收集和控制意外的溢出材料。台板31的表面可以涂有耐用成分来抑制由腐蚀剂和净化剂引起的降解，腐蚀剂例如化疗化合物和药物，净化剂例如漂白剂、异丙醇和类似物。在特定配置中，耐用成分可以是环氧树脂或环氧基的油漆或涂料。
在另一实施例中，台板31可以从秤9的基部单元43移除。在该配置中，台板31可以是一次性的，技术员可以在单次无菌药品配制程序后移除和处理台板31。在该配置中，秤9需要针对与基部43接合的每一个台板31进行校准。在一可选的配置中，台板31可以包括一次性的盖子层，盖子层可以在单次无菌药品配制程序后移除和处理。台板31的一次性保证在每次配制程序前台板31是清洁的，而且没有污染物可以转移到药品配制程序的成分中。台板31可以由常规已知用于秤称重表面的金属、复合材料或聚合物材料制成。在进一步的配置中，每一台板31和/或一次性的盖子层可以包括唯一的嵌入其内或者附着其表面的独特标识符45，独特标识符45可以由图像采集设备15捕捉到图像中。这让药品配制程序的技术员和/或随后的由图像采集设备15捕捉的图像的审查员核实台板31在各次制备之间已更换。这可以给技术员遵守安全制度和无菌要求提供证明文件。在一些配置中，独特标识符45可以由系统软件探测来确定在规定的时间间隔是否更换了台板31，例如，在换更、一天、在制备期间和/或检测到污染物后的指定时间点。在进一步的配置中，更换台板31的需要可以通过用户界面3展示给用户，例如通过GUI。在进一步的配置中，系统可以包括安全特性来防止用户在台板31更换之前实施配制程序。在确认台板31的使用时间符合依从性参数前，禁止用户使用秤9和台板31来进行无菌配制程序。
在进一步的配置中，在能够采用适当的处置技术之前，台板31可以包括吸收意外溢出的物质的吸收性材料。在进一步的配置中，台板31的至少一个接收井47内可以包括吸收性材料。
在特定情形下，例如烟雾化，技术员很难确定细胞毒素物质是否从容器中意外地释放出来。因此，台板31的上表面41可以包括涂层，涂层提供对液体接触涂层做出响应的可视指示，例如改变颜色。在一个配置中，涂层提供对材料泄漏或者意外溢出到台板31的涂层做出相应的可视指示。涂层可以配置成在接触细胞毒素物质时改变颜色。可视指示可以由技术员或者系统用户视觉上观察到。在另一配置中，可视指示可以由图像采集设备15或附加的图像采集设备观察到，例如红外摄像机。
在更进一步的配置中，台板31可以由允许光透过的透明和/或半透明材料制成。在该配置中，秤9的基部可以包括照亮部分台板31的光源49，例如光线从台板31底部的位置透过台板31。这提高与药品制备相关的药物37和相关用品的目视检验保证它们没有缺陷。例如，被照亮的台板31可让技术员观察到充满液体的IV袋的结晶。光源49可以调至特定波长，以适合照亮与药品制备相关的药物37中存在的特定粒子。在特定的配置中，为选择性地照亮台板31的某些部分，台板31可以包括不透明或者基本不透明的区域和透明、基本透明、半透明和/或基本半透明的区域。
在另一配置中，扫描器可以封装在秤9的基部43内。扫描器可以是条形码扫描器，其光学地配置成透过台板31的半透明和/或透明部分来扫描与药品制备相关的药物37上的条码标签。条形码扫描器可以配置成从条形码获取信息来确认置于台板31上的药瓶的内容物。在更进一步的配置中，条形码印写器或集成标签打印机可以设置在秤9的基部43内来将信息写入置于台板31上的与药品制备相关的药物37的标签。在一配置中，条形码印写器可以配置成将关于制备结果、日期、时间、批号及其他相似的信息写入置于台板31上的与药品制备相关的药物37的标签。
在又一更进一步的配置中，台板31可以无线联通一个或多个系统组件。例如，台板31电联通无线接口，该无线接口读取和/或写入数据至设置在台板31上方的装置。无线接口可以蓝牙连接与置于台板31上的药品容器连接的泵。因此信息传送可以包括泵的运行参数，例如病人比流量和容量。因此，可以设置无需用户更多的操作步骤的自动编程装置。
在更进一步的配置中，台板31可以配置成当秤9测量到在指定公差内的重量时显示可视标识，比如改变颜色。例如，台板31可以配备发光显示器，发光显示器只要秤9稳定且被测量单元在规定的药品制备过程的指定公差内就被激活。
运行时，可以通过设置在用户界面3显示器的一系列显示屏来提醒药剂师/技术员进行后续的步骤。首先，操作者可以用条形码扫描器13扫描与药品制备相关的药物37上的第一条形码，与药品制备相关的药物37包括为制备处方药物化合物而重新配制的药品。药物容器在扫描时可以放置在秤9上，或者用户可以首先扫描条形码然后将与药品制备相关的药物37放置在秤9的台板31上。只要重量稳定，系统就用数学算法核实测量的重量满足目标重量正/负预设公差。另外，图像采集设备15拍摄与药品制备相关的药物37的图像并在用户界面3的显示器显示给用户。然后用户将与药品制备相关的药物37从台板31移走，图像则保存到药品制备的数据记录中。如果系统无法核实测量的重量在目标重量公差内，就要求技术员重新执行该步骤直到获得正确的重量。
下一步，技术员扫描液体容器的第二条形码，其中的液体混合了待重新配制的药品。如上面所述，装有液体的药物容器在扫描时可以放置在秤9上，或者用户可以首先扫描条形码然后将与药品制备相关的药物37放置在秤9的台板31上。只要重量稳定，图像采集设备15拍摄与药品制备相关的药物37的图像并在用户界面3的显示器显示给用户。然后用户将与药品制备相关的药物37从台板31移走，图像则保存到药品制备的数据记录中。重申，如果系统无法核实测量的重量在目标重量公差内，就要求技术员重新执行该步骤直到获得正确的重量。
其后，用户通过将液体容器内的液体注射入药物容器，来混合待重新配制的药品和液体容器内的液体、与药品制备相关的两种药物37。然后将药物容器放回秤9的台板31来核实药物容器的重量。当重量稳定且被核实，图像采集设备15基于从秤接收到的信号自动拍摄全部与药品制备相关的药物37的图像，并将图像显示在用户界面3的显示器上。如果系统无法核实测量的重量在目标重量公差内，就要求技术员重新执行该步骤直到获得正确的重量。
如果技术员判定上述任何图像不满足特定要求，可以选择要求新的图像或者额外的图像。要求另外的照片可以自动地将图像采集设备15切换成在用户界面3显示的“视频直播模式”。技术员现在能够移动药物容器到秤9上的优选位置，并通过用户界面3触发图像捕捉。如前文所述，捕捉的图像会显示在用户界面3，技术员通过从秤9移走物品接受图像且系统自动地移至下一个制备步骤。
当药品制备完成，系统可选择地打印条码标签放置在完成的药品制备上，包括表示药物名称和病人信息的编码信息。
药物制备系统1可以与几个连续的计算机实现模块协作运行来制备和管理处方流体化合物，例如化疗化合物。每一个模块包括允许用户输入、生成输出、可由一个或多个处理器计算和确定制备和管理药物化合物指令的代码。具体地，模块可以允许医师给病人输入药方，药方的准确性随后经核实，药方的准备基于电脑辅助指令，药方的核实基于重量测量，并交付给病人。模块在药品制备过程中可以：(i)从医院内部网络检索医师在CPOE模块输入的药方信息数据；(ii)核实扫描的条形码与处方信息一致；(iii)确定注射器和/或IV袋的重量是否在待交付药物量的预设阀值精度标准内；(iv)确定如果重量不准确时进行的调整；(v)传输与注射器和/或IV袋重量相关的数据回医院内部网络。这些模块和流程可以在几个联网的计算装置或者具有自身处理器的独立计算装置实施，所述独立计算装置采用任何适当的有线或无线通信协议来通信数据和信息，例如但不限于以太网(Ethernet)、WiFi、蜂窝(cellular)、蓝牙(Bluetooth)等。
因此，本发明在药房通过在电脑屏幕上提供逐步指令和通过秤来测量复合液体的重量来核实不同配制步骤来指导药剂师或技术员完成不同的配制步骤来准备用药医嘱。然后用数学算法来分析测量的重量，检验是否已完成必要的配制精度。每次物品放置在秤上，秤顶部的照片都会被拍摄来创建配制过程的可视文件线索。照片连同秤的记录测量值和算法结果一起存储在日志文件。如果药品的测量重量不在预期重量的预定公差范围内，软件生成指令改变药品量来使其在可接受的公差范围内。只要未完成当前步骤所需的公差，软件不会进行下一配制步骤。
尽管发明的具体实施例详细描述细节，可以预期的是本领域的技术人员根据披露的整体教导可以开发这些细节的不同修改和替换。因此，所披露的特定布置仅为示例性，不限制发明范围，本发明的范围由所附权利要求书及其任何及其等同物的全部范围来规定。

Claims (13)

1.用于无菌配制的系统，包括：
带支撑台板的基部的秤，所述秤联通显示其输出的用户显示器；和
由连接至基部的支撑臂支撑的外壳，所述外壳封装：
具有捕捉置于台板上的物体最少一个图像的视场的图像采集设备，所述采集设备联通用户显示器来显示捕捉到的图像，和
带有传感器的条形码扫描器，该条形码扫描器相对于台板倾斜，
台板内设有用于识别图像采集设备部分视场的视觉标识符；和
视觉标识符是多条在台板的上表面内的凹槽，其中多条凹槽包括至少一个井，所述至少一个井配置成将液体限制在台板上。
2.根据权利要求1所述的系统，其中的图像采集设备设置在台板上方。
3.根据权利要求1所述的系统，其中的台板的视觉标识符包括十字形凹部。
4.根据权利要求1所述的系统，其中的台板配置成单次使用后即进行处理。
5.根据权利要求1所述的系统，还包括布置在台板至少部分顶面上的盖子，其中的盖子配置成单次使用后丢进行处理。
6.用于无菌配制的系统，包括：
秤，其具有基部和由基部支撑的一次性台板，秤联通用于显示其输出的用户显示器；和
用于捕捉置于台板上的物体最少一个图像的视场的图像采集设备，图像采集设备联通用户显示器来显示捕捉到的图像，
其中的一次性台板包括吸收性材料以吸收在无菌配制过程中使用的液体，台板的上表面包括增粘剂，其配置成增加台板的摩擦力,并且
台板内设有用于识别图像采集设备部分视场的视觉标识符,所述视觉标识符是多条在台板的上表面内的凹槽，其中多条凹槽包括至少一个井，所述至少一个井配置成将液体限制在台板上。
7.根据权利要求6所述的系统，其中的台板在其中限定有接收井，吸收性材料设置在接收井内。
8.用于无菌配制的秤，包括：
基部和由所述基部支撑的台板，台板上设有涂层，
所述涂层提供了对液体接触涂层做出响应的可视标识,并且
台板内设有用于识别图像采集设备部分视场的视觉标识符,所述视觉标识符是多条在台板的上表面内的凹槽，其中多条凹槽包括至少一个井，所述至少一个井配置成将液体限制在台板上。
9.根据权利要求8所述的秤，其中至少部分涂层对细胞毒素物质接触涂层做出响应而改变颜色。
10.用于无菌配制的秤，包括：
内置有照射源的基部和由所述基部支撑的台板，台板包括透光部以允许照射源照亮置于台板上的物体,并且
台板内设有用于识别图像采集设备部分视场的视觉标识符,所述视觉标识符是多条在台板的上表面内的凹槽，其中多条凹槽包括至少一个井，所述至少一个井配置成将液体限制在台板上。
11.用于无菌配制的秤，包括：
包括内置有条形码扫描器的基部和由所述基部支撑的台板，台板包括透光部以允许条形码扫描器扫描置于台板上的物体的条形码，并且
台板内设有用于识别图像采集设备部分视场的视觉标识符,所述视觉标识符是多条在台板的上表面内的凹槽，其中多条凹槽包括至少一个井，所述至少一个井配置成将液体限制在台板上。
12.用于无菌配制的系统，包括：
带台板的秤，所述秤联通用于显示其输出的用户显示器；和
具有捕捉置于台板上的物体最少一个图像的视场的图像采集设备，所述图像采集设备联通用户显示器来显示捕捉到的图像，
其中的台板包括独特标识符，独特标识符向用户指示台板是否已在秤上使用了一定的使用时间，并且
台板内设有用于识别图像采集设备部分视场的视觉标识符,所述视觉标识符是多条在台板的上表面内的凹槽，其中多条凹槽包括至少一个井，所述至少一个井配置成将液体限制在台板上。
13.根据权利要求12所述的系统，在确定台板的使用时间处于依从性参数的范围之内之前，禁止用户进行无菌配制程序。
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