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CN115876297A - 用于药物制备系统的输入装置的符合空气动力学的流线型外壳 - Google Patents

用于药物制备系统的输入装置的符合空气动力学的流线型外壳 Download PDF

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CN115876297A
CN115876297A CN202310066540.9A CN202310066540A CN115876297A CN 115876297 A CN115876297 A CN 115876297A CN 202310066540 A CN202310066540 A CN 202310066540A CN 115876297 A CN115876297 A CN 115876297A
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M·诺维茨基
C·森德曼
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Becton Dickinson and Co
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Abstract

一种用于制备药物化合物的系统包括:秤,具有压盘,所述压盘被构造用于在其上放置物体;支撑臂,包括与所述秤的一部分联接的第一端和伸出到所述秤的所述压盘上方的位置的第二端;以及外壳罩,从所述支撑臂的第二端伸出并且被构造成容纳至少一个输入装置。所述外壳罩具有弯曲前轮廓,以使当所述系统设置在流罩中时使流扰动最小。

Description

用于药物制备系统的输入装置的符合空气动力学的流线型 外壳
本申请是申请号为201580059668.6,申请日为2015年9月8日,发明名称为“用于药物制备系统的输入装置的符合空气动力学的流线型外壳”的分案申请。
相关申请的交叉引用
本申请要求2014年9月8日提交的名称为“Automated Visual DocumentationFeature with Minimal User Input”的美国临时专利申请序列号62/047,325、2014年10月29日提交的名称为“Enhanced Pharmacist Review Module for a System for Preparinga Pharmaceutical Compound”的美国临时专利申请序列号62/072,160、2014年10月29日提交的名称为“Aerodynamically Streamlined Enclosure for Input Devices of aMedication Preparation System”的美国临时专利申请序列号62/072,054、2014年11月11日提交的名称为“Aerodynamically Streamlined Enclosure for Input Devices of aMedication Preparation System”的美国临时专利申请序列号62/078,067和2014年11月11日提交的名称为“Enhanced Platen for Pharmaceutical Compounding”的美国临时专利申请No.62/077,968的优先权,这些专利申请中的每个的全部公开特此以引用方式并入。
技术领域
本发明总体上涉及一种符合空气动力学的流线型外壳,该流线型外壳用于容纳作为药物制备系统的部件,诸如扫描仪和/或相机的输入装置。该流线型外壳可被放置在流罩内并且可设置在秤的上游气流附近。
背景技术
制备无菌药物化合物通常是发生在流罩中,流罩提供用于形成洁净区域的气流。在进行这些制备期间,可利用相机、扫描仪和/或秤来记录制备过程。这些装置通常位于流罩内并且设置在秤的上游气流附近。然而,任何物体都将形成气流扰动,而气流扰动将影响物体的下游气流。如果例如在秤的上游附近存在该流扰动,则它会导致秤的称量表面附近有不一致的压力或湍流状况。根据作为多个形式参数和位置的函数的流扰动程度,这会导致秤根本不能稳定下来。不能稳定下来的秤不可用于准确地制备诸如无菌复合药物的药物。在某些情况下,该流扰动会导致准确性公差超过用于药物制备的系统的可接受极限。
因此,需要将导致系统的秤附近的流扰动较小从而更有可能满足准确性和稳定性要求的较小和/或更流线型的装置。
发明内容
按照本发明的一方面,提供了一种用于制备药物化合物的系统。该系统包括:秤,其具有压盘,所述压盘被构造用于在其上放置物体;支撑臂,其包括与所述秤的一部分联接的第一端和延伸到所述秤的所述压盘上方的位置的第二端;以及外壳罩,其从所述支撑臂的第二端伸出并且被构造成容纳至少一个输入装置。所述外壳罩具有弯曲前轮廓,以使当所述系统设置在流罩中时使流扰动最小。
所述外壳罩可由上部部分和下部部分形成。另外,所述外壳罩可包括与所述支撑臂的第二端联接的第一端和延伸到所述秤的所述压盘上方的第二端。所述外壳罩的第二端的至少一部分的高度可大于所述外壳罩的第一端的至少一部分的高度。
所述至少一个输入装置可包括图像采集装置、条形码扫描仪或二者兼有。如果在所述外壳罩内同时设置图像采集装置和条形码扫描仪,则所述条形码扫描仪可相对于所述图像采集装置的视野,相对于所述外壳罩内的所述图像采集装置倾斜,诸如成45°的角度。
按照本发明的另一个方面,提供了一种用于制备药物化合物的系统。该系统包括:计算装置,其包括处理器和用户界面,所述用户界面为操作人员提供用于制备所述药物化合物的指令;秤,其可功能性地联接到所述计算装置的处理器;以及外壳罩,其包括图像采集装置和条形码扫描仪。所述外壳罩由支撑臂支撑并且联接到所述秤的一部分。所述图像采集装置可功能性地连接到所述计算装置的所述处理器并且具有被放置用于拍摄放置在所述秤上的物体的视野。所述条形码扫描仪具有偏移所述秤的传感器。
所述条形码扫描仪可相对于所述外壳罩内的所述图像采集装置倾斜。例如,所述条形码扫描仪可相对于所述图像采集装置的视野倾斜成45°的角度。所述外壳罩可由所述支撑臂支撑,使得所述外壳罩放置在所述秤上方。所述外壳罩可具有使流罩内的流扰动最小的弯曲前轮廓。
按照本发明的另一方面,提供了一种用于制备药物化合物的系统。该系统包括:计算装置,其包括用户界面,所述用户界面为操作人员提供用于制备所述药物化合物的指令;以及流罩,在其中设置有:秤,其可功能性地连接到所述用户界面;以及外壳罩,其包括相机,所述相机被放置用于在制备所述药物化合物期间采集所述秤的图像。
所述外壳罩可放置在所述秤上方。所述外壳罩还可包括条形码扫描仪。所述条形码扫描仪可具有使流罩内的流扰动最小的弯曲前轮廓。
在参考附图考虑到以下的描述和随附权利要求书的情况下,其中所有附图形成本说明书的一部分,本发明的这些和其他特征和特性以及结构的相关元件与部件的组合的运行方法和功能,和制造经济化将变得更清楚,其中,相同的参考标号指代各幅图中的对应部件。然而,要明确地理解,附图只是出于示例和描述的目的,而不旨在定义为本发明的限制。如说明书和权利要求书中使用的,除非上下文另外清楚指明,否则单数形式“一”、“一个”和“该”也包括复数指代物。
附图说明
图1是本发明实施例的用于制备制药化合物的示例性药物制备系统的立体图。
图2是本发明实施例的在具有用户界面的层流罩中的图1的药物制备系统的立体图。
图3是本发明实施例的图1的药物制备系统的一部分的爆炸立体图。
图4是本发明实施例的秤压盘的立体图。
图5是本发明实施例的图4的秤压盘的俯视图。
图6是本发明实施例的沿着图5的线D-D截取的图4的秤压盘的凹槽的剖视侧视图。
图7是本发明实施例的具有用于输入装置的符合空气动力学的流线型外壳的层流罩的立体图。
图8A是具有秤而没有外壳的流罩内的气流分布的立体视图。
图8B是具有秤而没有外壳的流罩内的气流分布的侧视视图。
图9A是具有秤和大平整外壳的流罩内的气流分布的立体视图。
图9B是具有秤和大平整外壳的流罩内的气流分布的立体视图。
图10A是具有秤和中等尺寸平整外壳的流罩内的气流分布的立体视图。
图10B是具有秤和中等尺寸平整外壳的流罩内的气流分布的侧视视图。
图11A是具有秤和中等尺寸流线型外壳的流罩内的气流分布的立体视图。
图11B是具有秤和中等尺寸流线型外壳的流罩内的气流分布的侧视视图。
图12A是具有秤和小尺寸流线型外壳的流罩内的气流分布的立体视图。
图12B是具有秤和小尺寸流线型外壳的流罩内的气流分布的侧视视图。
图13A是具有秤和小尺寸缩短的流线型外壳的流罩内的气流分布的立体视图。
图13B是具有秤和小尺寸缩短的流线型外壳的流罩内的气流分布的侧视视图。
图14是本发明实施例的秤和外壳罩的侧视图。
图15是沿着线A-A截取的图14的外壳罩的剖视图。
图16是沿着线B-B截取的图14的外壳罩的剖视图。
具体实施方式
下文中,出于描述的目的,术语“上”、“下”、“右”、“左”、“垂直”、“水平”、“顶”、“底”、“横向”、“纵向”及其派生词应当如同它在附图中取向地关联到本发明。然而,要理解,本发明可采取各种替代的变形形式,除非明确相反指明之外。还要理解,附图中示出的和以下说明书中描述的特定装置仅仅是本发明的示例性实施例。因此,与本文中公开的实施例相关的特定尺寸和其他物理特性将不被视为是限制。
本发明涉及一种符合空气动力学的流线型外壳,该流线型外壳用于容纳作为诸如无菌药品化合系统的药物复合系统的部件的诸如扫描仪和/或相机的输入装置。这些装置通常位于流罩内并且放置在秤的上游气流附近。以使因在层流气流流体中有装置而形成的气流扰动最小这样的方式来设计符合空气动力学的流线型外壳。该构造允许装置被布置在秤的上游附近,并且出于验证药物制备目的,仍然具有可接受的重力分析准确性(即+/-0.05g)和稳定时间(即不另外超过2秒)。
任何目的将形成将影响物体的下游气流的气流扰动。如果在秤的上游附近存在该流扰动,则它会导致秤的称量表面附近有不一致的压力或湍流状况。根据作为多个形式参数和位置的函数的流扰动程度,这会导致秤根本不能稳定下来。不能稳定下来的秤不可用于准确地制备诸如无菌复合药物的药物。在某些情况下,该流扰动会导致准确性公差超过用于药物制备的系统的可接受极限。
较小和/或更流线型的装置将导致流扰动较小,因此更有可能满足准确性和稳定性要求。本发明的流线型外壳具有使流扰动和阻力最小的形式,从而实现足够稳定且准确地进行出于药物制备目的而需要的重力分析读数。本发明的流线型外壳实现了在将输入装置布置在相对于秤的上游气流附近的同时使重力分析秤具有所需的准确性和稳定性。将这些物体(即,扫描仪和/或相机)布置在秤附近通常是出于多种原因的理想区域。本发明的流线型外壳的第二个优点是为无菌药物制备提供和保持洁净的工作环境。在使用中,流罩中气流的目的是出于卫生原因而形成洁净区域。在气流附近或上游的物体所形成的湍流会导致在药物制备期间有可能存在污染威胁。结果,因具有用于输入装置的符合空气动力学形状的外壳罩,使层流气流扰动量最小并且减少了任何类型污染的机会。
按照本发明的一个方面,单个外壳容纳秤上方的至少一个输入装置。外壳可以容纳秤上方的诸如扫描仪和相机的多个输入装置。外壳是足够小的并且是足够流线型的,使得它对秤的稳定性和准确性的影响最小。
在某些情况下,输入装置外壳可被定位于秤的侧面或背面,而不是直接设置在相对于气流方向的秤的称量表面的上游附近。该构造可提供稳定且准确的重力分析秤读数,因为扰动气流不会到达秤的称量表面附近,然而,输入装置将设置在不太理想的位置。例如,如果输入装置是相机,则相机的这个侧面或背面布置将最有可能需要以立体视角拍摄照片。如果输入装置是扫描仪,则这个侧面或背面布置将为扫描仪提供供用户使用的有可能不太符合人体工程学的位置。
在其他情况下,输入装置可具有小得足以适于在没有任何外壳的情况下进行使用的占用面积。该构造可提供有效符合人体工程学的扫描和以直接从上到下视角拍摄的照片的能力。该构造可能需要装置本身的外壳被优化从而使气流扰动极小。
在其他情况下,将输入装置定位在秤上方但处于一定取向和/或在附加气流操纵特征的辅助下可导致空气被充分抽离秤的称量表面,从而没有对秤的重力分析读数产生可察觉的效果。类似地,附加气流操纵特征可被设计成使扰动的空气充分地重新取向,使得当空气碰到秤的称量表面时,它被充分偏转和/或抑制,使得它没有不利地影响秤的稳定性和准确性。
在另一个构造中,可设置包围秤的外壳(即,与高准确度秤一起使用的盒状罩),以便消除对重力分析读数的任何类型的可能气流扰动。用于秤的平整、不符合空气动力学外壳可以在有限数量的罩下实现重力分析的稳定性和准确性要求,因为对于不同的罩,气流的模式和流速有所不同。
在另一个构造中,秤可被设置成对噪声环境进行高度过滤或者处理秤的逻辑系统外部的重力分析信号。该构造可被用作用平整或非流线型物体获得更准确且稳定结果的解决方案。
在另一个构造中,秤的压盘可按气流扰动对秤读数的影响最小化的方式进行设置。将装置抬高到秤上方足够高可以是用具有平整或非流线型物体获得更准确且稳定的结果的解决方案。
对于55-80cfm的向下流动速率,秤在无菌复合中使用的典型罩下方的灵敏度是大约(+/-0.05g)。为了理解为什么是这种情况,需要理解在秤的称量表面上看到的压力及其与所希望准确性的关系。根据模拟,压盘(秤的称量表面)承受的压力的范围是-1.2Pa至0.1Pa,其平均值是大致-0.07Pa。为了获得+/-0.05g的准确性,由于气流扰动,导致秤可承受不超过+/-0.0126Pa的偏差。相比于秤承受的整体压力范围,这是极其小的。就质量而言,该幅度如此小,使得在表面附近移动的用户手部可容易地引起足够的空气移动导致大得多的压力扰动。结果,实现诸如流罩内的形式位置(不同区域中的不同流动模式)和罩铭牌/模型的参数,使其对秤的稳定性和准确性的性能有足够大的影响。
参照图1至图2,总体被表示为参考标号1的药物制备系统辅助药剂师或非药剂师技术人员制备含有一种或更多种处方制药化合物的注射器、药瓶或静脉注射(IV)袋。药物制备系统功能性地连接到用户界面3,用户界面3包括具有处理器和所容纳的存储器的计算机以及显示器5和诸如键盘、鼠标等的用户输入装置7。具有秤输出界面11的秤9可以功能性地连接到用户界面3的处理器。秤9可被实现为当物体被放置在其上时检测质量或重量改变的任何合适装置。因此,秤9可仅仅被构造为当物体的质量或重量大于或小于预定阈值时发送信号的装置或提供布置在其上的物体的重量准确读数的高精度秤。
在一个实施例中,条形码扫描仪13可以功能性地连接到用户界面3和的处理器和秤9中的至少一个,使得条形码扫描仪13可扫描布置在秤9的一部分上的具有条形码的药瓶。在另一个实施例中,图像采集装置15可以功能性地连接到用户界面3和秤9中的至少一个,使得图像采集装置15可拍摄布置在秤9的一部分上的诸如药瓶、IV袋或注射器的物品的照片。在一个实施例中,图像采集装置15可采集整个药物复合过程期间布置在秤9的一部分上的物品的多个静止图像或运行视频,以便记录和/或后续查看药物复合过程。
在另一个实施例中,条形码扫描仪13和图像采集装置15中的至少一个可至少部分被封入外壳17中。在某些构造中,外壳17可完全包围条形码扫描仪13和图像采集装置15。可选地,外壳17可只包括条形码扫描仪13和图像采集装置15中的一个。在一个构造中,条形码扫描仪13可放置在外壳17内,使得在用户没有进一步操纵的情况下,条形码扫描仪13可容易地扫描布置在秤9的一部分上的物品的条形码。在另一个构造中,图像采集装置15可设置在外壳17内,使得图像采集装置可在用户没有进一步操纵的情况下,容易地采集布置在秤9的一部分上的物品的图像。
具体参照图3,外壳17可由上部部分17A和下部部分17B形成,上部部分17A和下部部分17B连接,以提供最小的表面扰动,从而使诸如微生物或其他病原体的污染物的任何表面粘附性降至最低。在一个实施例中,将外壳17的制品遵照USP 797。光学透镜6、8可与外壳17装配在一起,以进一步确保遵照USP 797。在一个构造中,光学透镜6可与外壳17装配在一起,以与图像采集装置15进行光学通信。在另一个构造中,光学透镜8可与外壳17装配在一起,以与条形码扫描仪13进行光学通信。
在一个构造中,条形码扫描仪13可放置在外壳17内,使得条形码扫描仪13具有扫描仪,在用户没有进一步操纵的情况下,扫描仪偏移,无法立即扫描布置在秤9的一部分上的物品的条形码。在该构造中,避免出现意外扫描。如图3中所示,条形码扫描仪13可被放置成,使得传感器相对于秤的压盘31倾斜,诸如通过安装支架18对其成45°的角度。在该构造中,用户必须主动将待扫描物体放置在条形码扫描仪13的传感器的范围中。在另一个构造中,图像采集装置15可放置在外壳17内,使得图像采集装置可在用户没有进一步操纵的情况下,容易地采集布置在秤9的一部分上的物品的图像。
外壳17可放置在诸如由支撑臂19支撑的秤9的一部分上方。如图2中所示,药物制备系统1可放置在具有入口空气源23和出口空气端口27的层流罩25内,以在层流罩25的内部29内形成空气的层流。外壳17的外部表面21可具有如图1至图3中所示的弯曲前表面,以为其提供流线型形状和/或轮廓,该形状和/或轮廓被优化以减小层流罩25内的气流扰动。
再参照图1至图3,秤9可包括底部部分43,底部部分43将压盘31支撑于其上。底部部分43容纳应变式称重传感器和诸如承重传感器的力转换器,应变式称重传感器测量布置在压盘31上的物体的应变,力转换器将施加到压盘31的力转换成电信号,电信号可被传达到秤输出界面11。底部部分43支撑压盘31,诸如秤9的称量表面的一部分,压盘31可向技术人员提供图像采集装置15待采集的图像的中心或其他所期望部分的诸如十字槽35的可视指示。这样允许技术人员在图像采集装置15,诸如封入放置在秤9的压盘31上方的外壳17内的图像采集装置的视野内正确地放置药品复合相关药物37和相关物资。在一个构造中,如图4至图6中所示,压盘31的上表面41可限定多个凹进凹槽39和/或从压盘31的表面伸出的突起,以将药品复合相关药物37和相关物资摩擦限制在压盘31的上表面41上。在另一个构造中,压盘31的上表面41可包括增粘剂或其他摩擦增强表面,以类似地将药品复合相关药物37和相关物资限制在压盘31的上表面41上。凹槽39和/或突起的布置可不费力地向用户指示压盘31的中心,压盘31的中心可被布置成与图像采集装置15的视野中心重合。压盘31的表面可被涂覆耐用组合物,耐用组合物抵抗因暴露于腐蚀剂,诸如化疗化合物和药品,以及清洁剂,诸如漂白剂、异丙醇等而造成的劣化。在某些构造中,耐用组合物可以是环氧树脂或基于环氧树脂的涂料或涂层。
多个凹进凹陷38和/或从压盘31的表面伸出的突起可被构造成,限制在复合过程期间意外溅到压盘31的上表面41上的任何液体材料。多个凹进凹槽39可以限定(图1中示出的)接收井(receiving well)47,接收井47用于在可采用正确的处置技术之前将意外洒出的材料收集和限制在压盘31内的受约束区域内。
在另一个实施例中,可从秤9的底部单元43取下压盘31。在该构造中,压盘31可以是一次性的,并且技术人员可在单次无菌药品复合过程之后取下并处理压盘31。在这个构造中,对于每个与底部43接合的个体压盘31而言,都会需要校准秤9。在替代构造中,压盘31可包括一次性覆盖层(未示出),可在无菌药品复合过程之后取下并处理该覆盖层。压盘31的一次性方面确保了在每个复合过程之前,压盘31是清洁的并且没有污染物会转移到药品复合过程的组分。压盘31可由金属、复合物或聚合物材料形成,如传统上对于秤的称量表面而言已知的。在其他构造中,每个压盘31可包括独特的个体标识符45,个体标识符45被嵌入其中或者附接到其表面,可被拍摄在图像采集装置15所采集的图像中。这样允许药物复合过程的技术人员和/或图像采集装置15所采集的图像的后续查看人员验证在不同制备之间,压盘31有更换。这样可提供技术人员遵照公共安全和无菌要求的文件证明。在某些构造中,可用系统软件来检测个体标识符45,以确定压盘31是否以指定间隔,例如,以换班、当日、制备和/或检测到污染之后的指定点处进行更换。在其他构造中,可通过用户界面3,诸如通过GUI来示出用户更换压盘31的需要。在其他构造中,系统可包括安全特征,使得可阻止用户执行复合过程,直到压盘31被更换。可阻止用户使用秤9和压盘31来制备无菌复合过程,直到确认压盘的持续时间在服从参数内。
在其他实施例中,压盘31可包含吸收性材料,在可采用正确的处置技术之前,吸收性材料可吸收意外溅出的材料。在其他构造中,压盘31的至少一个接收井47可在其中包含吸收性材料。
在诸如气溶胶(aerosolation)的某些情形下,技术人员可能难以确定是否已经从容器意外释放细胞毒素材料。因此,压盘31的上表面41可包括涂层,涂层响应于接触涂层的流体来提供诸如颜色改变的可视指示。在一个构造中,涂层可响应于压盘31的涂层上材料的泄漏或意外溅出来提供可视指示。涂层可被构造成在与细胞毒素材料接触时候提供颜色改变。对于技术人员或系统的用户而言,可视指示可以是能肉眼观察到的。在其他构造中,图像采集装置15或诸如红外相机的附加图像采集装置可能能观察到可视指示。
在其他构造中,压盘31可由允许光从中通过的透明和/或半透明材料形成。在该构造中,秤9的底部部分43还可包括光源49,光源49用于诸如通过使光从压盘31下方的位置穿过压盘31来照射压盘31的一部分。这样允许改良药品复合相关药物37和相关物资的肉眼检查,以确保它们不含缺陷。例如,被照射的压盘31可允许技术人员将流体填充IV袋中发现的粒化可视化。光源49可被调节成适于照射药品复合相关药物37内存在的某些颗粒的某一波长。在某些构造中,压盘31可包括不透明或基本上不透明的区域和透明、基本上透明、半透明和/或基本上半透明的区域,以选择性允许照射压盘31的某些部分。
在另一个构造中,扫描仪可被容纳在秤9的底部部分43内。扫描仪可以是条形码扫描仪,被光学配置成透过压盘31的半透明和/或透明部分扫描药品复合相关药物37上存在的条形码标签。条形码扫描仪可被配置成从条形码得到信息,以确定布置在压盘31上的药瓶的内容物。在其他构造中,条形码写入器或集成标签打印机可放置在秤9的底部部分43内,用于将信息写入布置在压盘31上的药品复合相关药物37的标签。在一个构造中,条形码写入器可被配置成将关于复合结果、日期、时间、批次号等的信息写入药品复合相关药物37的标签。
在其他构造中,压盘31可与一个或更多个系统部件无线通信。例如,无线接口可被设置成与压盘31电通信,可从设置在压盘31上方的装置读取数据和/或将数据写入该装置。无线接口可以是与泵的蓝牙连接,泵与设置在压盘31上的药品容器连接。由此传递的信息可包括诸如患者特定流速或体积的泵运行参数。因此,可在不需要进一步用户操纵步骤的情况下设置自动编程装置。
在其他构造中,压盘31可被构造成当秤9所测得的重量在指定公差内时,展示诸如颜色改变的可视指示符。例如,压盘31可装配有照射显示器,一旦秤9稳定下来并且被测单位在对于给定药品复合过程的指定公差内,就启动照射显示器。
在操作中,可通过设置在用户界面3的显示器上的一系列显示屏来提示药剂师/技术人员采用以下步骤。首先,操作人员可用条形码扫描仪13扫描药品复合相关药物37上的第一条形码,药品复合相关药物37包括将被重组以制备处方药物化合物的药品。可在进行扫描时,将药物容器布置在秤9上,或者用户可首先扫描条形码,随后将药品复合相关药物37布置在秤9的压盘31上。一旦重量稳定下来,系统就使用算术算法来验证所测得的重量正满足目标重量+/-预定公差。另外,图像采集装置15拍摄药品复合相关药物37的图像并且在用户界面3的显示器上向用户显示它。然后,用户从压盘31取出药品复合相关药物37并且将图像保存于药品制备的数据记录。如果系统不能验证所测得的重量在目标重量公差内,则需要技术人员重新执行该步骤,直到获得正确重量。
接下来,技术人员扫描将与待重组药品混合的流体的流体容器的第二条形码。如上所述,可在进行扫描时,将容纳流体的药物容器布置在秤9上,或者用户可首先扫描条形码,随后将药品复合相关药物37布置在秤9的压盘31上。一旦重量稳定下来,图像采集装置15就拍摄药品复合相关药物37的图像并且在用户界面3的显示器上向用户显示它。然后,用户取出药品复合相关药物37并且将图像保存于药品制备的数据记录。同样,如果系统不能验证所测得的重量在目标重量公差内,则需要技术人员重新执行该步骤,直到获得正确重量。
此后,用户通过将来自流体容器的流体注入药物容器中,将待重组药品与流体容器中的流体7混合,待重组药品与流体即两种药品化合相关药物3。然后,将药物容器放回秤9的压盘31,并且验证药物容器的重量。一旦重量稳定下来并且得以核实,图像采集装置15就自动地基于从秤接收的信号来拍摄完成的药品复合相关药物37的图像,并且将图像在用户界面3的显示器上显示。如果系统不能验证所测得的重量在目标重量公差内,则需要技术人员重新执行该步骤,直到获得正确重量。
如果技术人员决定上述图像中的任一个没有满足一定要求,则存在请求新或附加图像的选项。请求另一张照片可自动地将图像采集装置15切换成显示在用户界面3处的“直播视频模式”。技术人员此时可将秤9上的药物容器移动到优选位置并且通过用户界面3来触发图像采集。如前所述,将在用户界面3处示出被采集图像,并且通过从秤9取下物品,技术人员接受图像并且系统自动移至下一个复合步骤。
一旦药品制备完成,系统就可以可选地打印条形码标签,条形码标签被布置在完成的药品制剂上,包括表示药物的名称和患者信息的编码信息。
药物制备系统1可结合用于制备和管理处方流体化合物,诸如化疗化合物的多个连续计算机实现模块发挥作用。这些模块的每一个包括允许从用户输入、产生输出并且计算并确定用于制备和管理药物化合物的、可在一个或更多个处理器上实现的指令的代码。更具体地,这些模块可允许内科医生键入患者的处方,随后验证该处方的准确性、基于计算机辅助指令进行制备、基于重量测量进行验证并且施用于患者。在药品制备期间,这些模块可:(i)从医院内网络获取由内科医生输入CPOE模块中的处方信息数据;(ii)检验被扫描的条形码与处方信息对应;(iii)确定注射器和/或IV袋的重量是否在待施用药物的量的预定阈值准确度内;(iv)如果重量不准确的话确定必须进行什么调节;以及(v)向医院内网络发送回与注射器和/或IV袋的重量相关的数据。这些模块和处理可在多个联网计算装置或其自身具有处理器的独立计算装置上实现,其中,使用任何合适的有线或无线通信协议,诸如但不限于以太网(Ethernet)、WiFi、蜂窝、Bluetooth等,在计算装置之间进行数据和信息的通信。
因此,本发明通过在计算机屏幕上提供逐步指令并且通过用秤测量复合液体的重量来检验不同的复合步骤,从而引导药剂师或技术人员通过不同的复合步骤在药房中准备用药医嘱。然后,用数学方法来分析所测得的重量,以检查是否已经实现必需的复合准确性。每当将物品放置在秤上时,拍摄秤顶部的照片,以形成化合处理的可视化文档线索。照片与从秤记录的测量值以及算法结果一起被存储在日志文件中。如果所测得的药品重量不在预期重量的预定公差范围中,则软件生成改变药品量以使其在可接受公差范围内的指令。只要当前步骤的所需公差还未实现,软件就将不继续至下一个复合步骤。
实例
具体地,参照图7,示出具有70英尺/分钟的进口层流条件和533英尺/分钟的出口流条件的流罩。流罩包括0Pa的入口环境压力条件。流罩还包括秤的称量表面和正被使用的外壳。出于建模的目的,示出简化的一半模型环境。
参照图8A至图13B,示出一系列计算流体动态模拟,反映不同外壳形式之间的气流扰动差异。对于这些图中的每个,使用流轨迹和等流速线作为输出并且在每个模拟中使用相等的环境、栅格和边界条件。对于每次测试运行,采用3分钟稳定性测试,在该测试中,记录将在三分钟内没有被触摸而出现的任何振荡。对于测试运行,使用100g的重量并且运行25个样本测试。记录秤所记录的第一稳定值,并且计算两个标准偏差并且将它记录为准确度。
图8A至图8B表示在流罩中不存在外壳的理想化条件下的流罩中的气流。在这些条件下的秤的实验评价是+/-0.00g的稳定性和+/-0.0229g的准确度。为了理解对于秤稳定性而言关键的设计变量,必须理解如图8中所示的复合罩内的典型气流。在图8A中,流从流罩的顶部引导到底部并且在流罩的前方和后方的两个区域(用红色示出)中存在空气。在秤的压盘附近,空气分成可选的路径。参照图8B,由于外壳罩位于秤上方,因此外壳罩往往会形成下游的气流扰动,该气流扰动会导致秤不稳定和不准确。可优化某些外壳罩设计,以减少该下游气流扰动。
图9A至图9B表示放置在秤上方的流罩中存在的相对大的平整罩头部的流罩中的气流。这些条件下的秤的实验评价是+/-0.06g的稳定性并且作为所得秤读数的未知准确度太不稳定。
图10A至图10B表示放置在秤上方的流罩中存在的中等尺寸的相对平整罩头部的流罩中的气流。这些条件下的秤的实验评价是待定的。
图11A至图11B表示放置在秤上方的流罩中存在的中等尺寸的相对流线型罩头部的流罩中的气流。在这些条件下的秤的实验评价是+/-0.02g的稳定性和+/-0.0445g的准确度。
图12A至图12B表示放置在秤上方的流罩中存在的小尺寸的非常流线型罩头部的流罩中的气流。在这些条件下的秤的实验评价计是+/-0.015g的稳定性和+/-0.0297g的准确度。
图13A至图13B表示放置在秤上方的流罩中存在的中等尺寸但缩短的相对流线型罩头部的流罩中的气流。在这些条件下的秤的实验评价是+/-0.015g的稳定性和+/-0.0153g的准确度。
在图8A至图13B中的每个中,示出流罩内的空气的压力和空气速度。标记为B的区域对应于与最小气流扰动对应的最小空气速度和最低压力。相比之下,标记为R的区域对应于与最大气流扰动对应的最大空气速度和最高压力。
如图14至图16中所示,本发明的目的是使得到达秤9的压盘31的湍流量最小化。使外壳17和压盘31之间的距离“Z”最大化有助于允许因外壳17形成的任何扰动向着流罩的后方扫掠,之后到达压盘31的表面。使距离“Y”最小化以类似方式进行辅助,因为它与扰动空气在到达秤9的压盘31之前需要行进的距离直接相关。使“Y”和剖面直径a最小化导致与流体的正交区域最小,由此使气流扰动最小。使b/a剖面比率最大化与外壳17的平滑弯曲的结合在流体的方向上形成流线型轮廓。这样将使通过逐渐分开层流气流流体而变成湍流的空气量最少,并且随后允许它重新连接。
虽然已经详细描述了本发明的特定实施例,但本领域的技术人员应该理解,可以依照本公开的整体教导来形成对这些细节的各种修改和替代。因此,所公开的特定布置意指仅仅是示例性的,而非是对本发明的范围的限制,本发明的范围将由随附权利要求书及其任何和全部等同物的整个范围赋予。

Claims (19)

1.一种用于制备药物化合物的系统,所述系统包括:
底部,其包括具有压盘的秤,所述压盘构造用于在其上放置物体,压盘包括一个或多个凹进凹槽;
支撑件,其包括与底部的一部分联接的第一端和伸出到秤的压盘上方的位置的第二端;
外壳罩,其包括第一外壳罩端和第二外壳罩端,第一外壳罩端附接到支撑件的第二端并从支撑件的第二端伸出,并且外壳罩的第二端伸出到秤的压盘上方,使得图像采集装置的视野包括压盘,其中外壳罩具有弯曲轮廓,以使当系统放置在流罩中时使流扰动最小;
图像采集装置,其容纳在外壳罩内,并且功能性地连接到秤;以及
打印机。
2.根据权利要求1所述的系统,其特征在于,外壳罩的第二端具有使流罩内的流扰动最小的弯曲轮廓。
3.根据权利要求1所述的系统,其特征在于,支撑件布置成使得所述图像采集装置的视野中心与压盘的中心重合。
4.根据权利要求1所述的系统,其特征在于,打印机与底部是一体的。
5.根据权利要求1所述的系统,还包括容纳在外壳罩内的红外相机。
6.根据权利要求1所述的系统,还包括布置在底部的用户界面,用户界面功能性地连接到秤。
7.根据权利要求1所述的系统,其特征在于,外壳罩构造成使得秤的重量分析准确性为+/-0.05g。
8.根据权利要求1所述的系统,其特征在于,外壳罩构造成使得秤呈现不超过2秒的稳定时间。
9.根据权利要求1所述的系统,其特征在于,外壳罩构造成使得当系统放置在层流罩中时,将恒定的压力施加到秤。
10.根据权利要求1所述的系统,其特征在于,外壳罩构造成使得当系统放置在层流罩中时,使阻力最小化。
11.根据权利要求1所述的系统,其特征在于,第二外壳罩端包括沿着由第一外壳罩端和第二外壳罩端限定的轴线凹入的部分。
12.一种用于制备药物化合物的系统,所述系统包括:
底部,其包括具有压盘的秤,所述压盘构造用于在其上放置物体,压盘包括一个或多个凹进凹槽;
支撑臂,其包括与底部的一部分联接的第一端和伸出到秤的压盘上方的位置的第二端;
外壳罩,其包括第一外壳罩端和第二外壳罩端,第一外壳罩端附接到支撑臂的第二端并从支撑臂的第二端伸出,并且外壳罩的第二端伸出到秤的压盘上方,以及包括沿着由第一外壳罩端和第二外壳罩端限定的轴线凹入的部分,其中图像采集装置的视野包括压盘,其中外壳罩具有弯曲轮廓,以使当系统放置在流罩中时使流扰动最小;
图像采集装置,其容纳在外壳罩内,并且功能性地连接到秤;
红外相机,其容纳在外壳罩内;以及
打印机,其与底部成一体。
13.根据权利要求12所述的系统,其特征在于,外壳罩的第二端具有使流罩内的流扰动最小的弯曲轮廓。
14.根据权利要求12所述的系统,其特征在于,支撑臂布置成使得所述图像采集装置的视野中心与压盘的中心重合。
15.根据权利要求12所述的系统,还包括布置在底部的用户界面,用户界面功能性地连接到秤。
16.根据权利要求12所述的系统,其特征在于,外壳罩构造成使得秤的重量分析准确性为+/-0.05g。
17.根据权利要求12所述的系统,其特征在于,外壳罩构造成使得秤呈现不超过2秒的稳定时间。
18.根据权利要求12所述的系统,其特征在于,外壳罩构造成使得当系统放置在层流罩中时,将恒定的压力施加到秤。
19.根据权利要求12所述的系统,其特征在于,外壳罩构造成使得当系统放置在层流罩中时,使阻力最小化。
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