CN100359530C - 医用容器的rf-id标签 - Google Patents

医用容器的rf-id标签 Download PDF

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CN100359530C
CN100359530C CNB028146832A CN02814683A CN100359530C CN 100359530 C CN100359530 C CN 100359530C CN B028146832 A CNB028146832 A CN B028146832A CN 02814683 A CN02814683 A CN 02814683A CN 100359530 C CN100359530 C CN 100359530C
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CN1545681A (zh
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兰德尔·S·希克尔
萨姆松·兰波唐
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SCOTT LAB Inc
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Abstract

本发明涉及主要设备单元，诸如用于提供医疗医治的系统，其与智能医疗用品相关。该智能医疗用品被用数据载体标记，该数据载体可以编码这样的信息：如，医疗用品或部件的唯一的ID、医疗用品或部件的识别、该用品或部件来源的识别、所述该用品或部件以前是否被使用过的状态、以及该用品或部件的到期日期，并且在该医疗用品或部件包含药品的情况下该药品的纯度和药品的浓度。然后，该主要设备单元或其使用者利用该信息通过改进的使用前检查、所使用的医疗用品的证明书、保持的记录、库存控制以及诊治收费，以确保用所述单元进行的任何手术的质量。

Description

医用容器的RF-ID标签
技术领域
本发明涉及通过识别和证明医疗用品、部件和其他设备的来源或其制造商来鉴定产品。其中，这种鉴定确保通过产品合适的纯度、浓度、无菌状态、校准和制作公差来确保适当的配合和操作。本发明还涉及单个病人用的医疗用品或医疗部件一旦已经使用过就将其标为使用过的，以防止病人之间传染性疾病的交叉感染。
背景技术
许多医疗手术，诸如药品(例如镇静剂和镇痛药)的管理是与病人健康有关的正在争论中的安全临界课题。因此对医疗用品的来源及制造商的识别和证明以及将要给病人服用的药品识别是重要的。这种识别和证明通过确保和提高药物用的及单个病人用的用后可弃的设备的质量，包括确保诸如合适的纯度、浓度、无菌状况、校准及制造公差之类的标准来增强病人的安全。
用于防止已经用于一个病人的医疗用品在之后被另一个病人再次使用的手段也是重要的。因为由血液病原体引起的传染性疾病诸如人体免疫缺陷病毒(HIV)和乙型、丙型肝炎，以及由呼吸道病原体引起的疾病，诸如多重耐药肺结核，所以病人之间的交叉感染是一个关注的问题。还有，某些药品的污染已引起致命的败血病病例，因为这些化合物有助于细菌的生长。
为了防止交叉感染，医疗设备、部件和用品在不同的病人再次使用之前经常被消毒。但是，近来的研究表明，许多医疗设备的消毒，尤其是那些有阀门、复杂的机构或细而长的内腔(例如腹腔镜用的套管针、内窥镜活组织检查钳、纤维镜)的设备的消毒，可能不是完全有效。
避免交叉感染的备选方法是通过单个病人使用用后可弃的医疗用品和部件。用后可弃的医疗药品和部件如果再次使用将会引起交叉感染。因此，许多关注仍然是有关用后可弃的医疗用品和部件的有意和无意的再使用。除了病人交叉感染之外，关于那些未被设计、或未使有效地消毒或具有长的寿命周期的用后可弃的医疗用品的未许可的消毒状态和/或再次使用也是关注的问题。
具有合适的形状、配置和功能的与该医疗设备一起使用的外表看起来像医疗设备的部件和用品的货品实际上可能是未经鉴定的产品，即不是按照原始设计说明制造的产品。在许多性能的质量和可靠性是至关重要的情况下，消费者或者其他使用者或许不能辨别未经鉴定的部件与真正的部件之间的差别。例如，药品供给或者注射系统的适当使用需要药品浓度，注射管的死区容积和药品泵盒(pump cassette)、校准管和压缩面(为了产生药品注射速率的容积控制)的知识。这些信息可能不是公知的或在未被鉴定的注射系统的部件或用品的说明书的范围之外。
如果医疗用品是“智能”型的，那么经鉴定的医疗用品及它们的使用条件的存在和缺失的检测很容易自动进行。自动化可以使临床医生减轻杂务和鉴定产品的记忆负担，并可以通过在开始医疗手术前确保所有必要的用品到位并且是合适的、未用过的，来增加病人的安全。
此外，尽管制造商尽力保证最佳质量，但是被污染的和有缺陷的产品有时还会进入市场。随之发生的产品撤回对于制造商极费力。一种促进每种单个被撤回的产品的定位和去除的识别系统将是有益的。作为一种附加的安全措施，如果撤回产品的批号和唯一的识别号能够被编程进入到相关的供给装置将是有益的，像清醒镇静机，或者在任何分发地点，像药房或者集中化的数据库，使得任何被撤回的产品，例如从撤回中漏掉的被污染的药品小瓶会被供给装置拒绝。
发明内容
本发明提供一种用于允许医疗用品和医疗部件与医疗主要设备单元(例如，医疗处理系统，其中，诸如镇静和镇痛供给系统，麻醉机和工作台，X光机，透析机)和临床信息系统相互作用的设备和方法，以增进病人的安全同时提高临床处理流程的效率。
本发明提供一种用于通过向其使用者报告明显看出篡改的密封(tamper-evident seal)是不是完整无缺，以及对该具有该密封件的装置的检查和更换是不是过期来确保具有明显看出篡改的密封件(tamper-evident seal)装置的安全和有效使用的系统。还有，关于被包装的预先组装的成套器件，其中成套器件包括对某一特定的手术所需要的所有用品和部件，医疗的或其他的，或单个的医疗设备，本发明提供一种系统，该系统促进和监控仅在临使用前打开这些成套器件和装置的包装。这种促进和监控确保在病人使用前该成套器件和单个装置是无菌的。
关于一些医疗系统使用前的检查操作顺序，例如镇静和镇痛的给药装置(administration device)，本发明提供一种系统，该系统检测该系统的操作所需要的医疗用品和部件的存在或缺乏及使用条件。因此本发明可以在医疗系统的操作或作业开始之前通过确信所需要的用品和部件已备好、功能适合、并且是没有使用过来提高病人的安全。
根据本发明的一种系统能够跟踪单个药品容器，识别多少药品被使用过或甚至被浪费，并因此能够为减少浪费监控重建临床过程的功效。在本发明的另一个实施例中，提供用于实时跟踪注射器中的药品的成分及其浓度以及供给病人的数量的装置。本发明的这种跟踪当系统与包括病人的病史和体检的计算机化的医疗记录相耦连时能标识指示不适合(contra-indicated)病人的药品。
本发明还通过以下系统来提供器材跟踪和有效存货控制，该系统是用于跟踪和即刻定位医院中的可移动主要设备或其他设置以及用于监控存货(inventory)中哪些医疗用品和部件或用品已经到期或将要到期。另外，还提供一种系统促进定位和去除其制造商或管理机构所撤回的产品。
本发明还提供一种系统，其能迅速地确证实是否有异物留在外科手术空腔(cavity)中而不需要X射线辐射。
上面所述的各种信息跟踪和识别功能可能通过用指示器或“智能”标签标明医疗设备、系统部件、用后可弃的产品、可消耗的产品、或其他产品。本发明提供一种这样的指示标签，其形式为射频识别(“RFID”)标签，该标签可以粘贴在物体上，从而用能够被附近的读取器读出的某种些信息标明。RFID标签可以被写入以便储存附加的或更新的信息，或它可以被用作简单使用的指示器，因而当与该标签相关的物品以一种读者能够检测的方式被使用时标签被变更。本发明还提供用于使RFID标签屏蔽不想要的射频的装置。RFID标签具有若干优点，但是本发明还为上述功能提供用于标明设备的备选装置。一种另外的这种装置是电EEPROM标签，其能够储存很多有关贴有这种标签的物品的信息。
附图说明
图1是与易折断的导电回路相结合的射频识别(“RFID”)标签的视图；
图2是易折断的导电回路的RFID标签的透视图，该标签用作小瓶上的标牌；
图3是RFID标签连同至少一个线性阵列的霍尔效应传感器的侧视图，该RFID标签被用作注射器的标签；
图4是容纳有成套医疗器具或医疗用品或医疗部件的盒子的透视图，该盒子用具有可撕下的封皮的RFID标牌标记；
图5是电可擦可编程只读存储器(EEPROM)标签的部分分解图，示出了嵌入在可拆卸医疗用品或医疗部件中的EEPROM标签和连接在主要设备单元的EEPROM读取器/写入器之间的电接触；
图6是主要设备单元上的合适的连接器的示图，该连接器与EEPROM标记的医疗用品、医疗部件和用后可弃物一起使用；
图7是用后可弃用品或部件上的合适的连接器的示图，该连接器与EEPROM标记的医疗用品、医疗部件和用后可弃物一起使用；以及
图8是结合有RFID读取器/写入器的医疗设备，该医疗设备与连接在医疗用品或医疗部件、附件和外围设备的RFID标签和密封件阵列中的至少一个接口连接。
具体实施方式
医疗设备系统的识别子系统读取并鉴定该识别和/或药品、医疗用品、医疗部件的来源或与医疗设备系统相关的附属装置。这种医疗设备系统可以是镇静和镇痛供给系统，例如在1999年6月3日提交的序列号为09/324,759美国专利申请中所公开的，其整个内容通过参考结合在本文中。09/324,759号申请的镇静和镇痛供给系统包括适于与病人相耦连的并产生反映病人的至少一种生理状态的信号的病人健康监控装置；为病人提供一种或多种药品的药品供给控制器；存储安全数据集的存储装置，该安全数据集反映至少一种被监控的病人的生理状况的安全的和不希望的参数；以及连接在病人健康监控装置、药品供给控制器和存储安全数据集的存储装置之间的电子控制器；其中，所述的电子控制器接收所述信号并作出响应管理与安全数据集相一致的药品的应用。本发明的识别子系统可以与这种镇静和镇痛系统一起使用以进一步管理与有关药品、医疗用品、医疗部件或镇静和镇痛系统的附加装置的识别、来源或其他信息相一致的药品的应用。电子控制器所涉及的安全数据集还可以包括有关用于这样的药品、医疗用品、医疗部件或附加装置的识别和/或来源的适当值的数据。
与本发明的识别子系统有关的医疗设备系统还可以是任何数目的使用药品或其他可消费的或用后可弃的用品和部件的的其他系统。可能与本发明的识别子系统相关的其他系统的例子还包括麻醉系统(例如吸入机、麻醉机和工作台)、成像系统(例如，X光机、MRI、CAT)、治疗系统(如辐射和化疗机)、医治系统(例如透析机)、插入系统(例如心/肺旁通机、洗血球机(cell saver))、诊断系统(例如，结肠镜、乳房造影机)。
本发明提供一种装置，如果把未经鉴定的或以前使用过的药品、部件或用品加到相关的医疗设备系统上，该装置将防止医疗设备系统启动其被设计所具有的功能。例如，用镇静和镇痛系统，将防止镇静的和镇痛的药品的经营以确保该系统性能的可靠性。
有关序列号为09/324,759的美国专利申请的示例性的医疗设备系统，例如，关键功能的药品容器，其根据本发明进行识别，它包括，含有异丙酚(Propofol)、瑞芬太尼(remifetanil)、美托咪定(dexmedtomidine)、或静脉内的氙(溶解在液体乳化剂中的氙)。类似地，与所述的镇静和镇痛系统相连的并与其一起使用的关键功能的容器的医疗用品和医疗部件的例子包括呼吸监控器、氧气输送管道、药品注射盒、药品注射管、单向防逆流阀、病人声频耳机，以提供用于测试或监控的可听到的提示、以及复苏的成套器具(resuscitationkit)。
根据本发明，关键功能的药品容器、医疗用品和医疗部件，通过与它们有关的数据载体或“标签”识别，然后由读取装置读出。数据载体优选为通用的，数据不由标签的物理特性(诸如其基本的共振频率)表示。数据载体也可以简单地指示物体的状态为使用过或未使用过。数据载体或“标签”可以很小(例如3mm2)并可以存储相当大数量的数据。选择的标签优选具有等于或大于带有标签的产品本身的寿命。此外，选择的标签可以提供数据编码，该数据编码对标签的属性(例如物理尺寸或共振频率)来说是一般不是特殊的。还有，标签的数据存储容量优选足以建立每个单个的医疗用品或医疗部件的唯一的ID号码。可以与本发明一起使用的标签的例子是射频识别(“RFID”)标签。其他合适的电子标签技术包括可编程存储器，如EPROMS、EEPROMS和磁条。
图1示出加在薄背衬(backing)14上的RFID标签10，薄背衬14由诸如自粘接纸之类的材料制成，可以用手撕下。RFID标签10包括微型集成电路19和天线12。导电回路16设置在背衬14上并且通过导电迹线和垫片(pad)18与集成电路19电连接，导电回路16(among others)其中可以用导电墨水或微细的易折断的导线(如，铜)来实现。导电的垫片18还提供物理的分隔，以使导电回路16能够用具有粗分辨率的导电胶水设置在或连接在RFID标签10上。在实施例中，导电回路是易折断的，当易折断的回路折断时，例如当薄背衬薄膜14被撕破时，RFID标签上的数据被机械地可再编程。
在特定的实施例中，本发明使用无源的、廉价的、用后可弃的、非接触式的、不易挥发的读/写射频识别(RFID)标签以鉴定医疗用品或医疗部件并为一次使用的和多次使用的医疗用品指示其使用状态(诸如，使用过、未使用过、曾到期或检查日期、使用过的次数)。当与可操作地耦连于读取器/写入器的主要设备单元(capitalequipment unit)结合使用时，读取器/写入器的读/写区域最好是设置成围绕带有标签的医疗用品的标签。RFID读取器/写入器加到医疗设备系统上或与其相关，并且与该系统的CPU通信。该系统的CPU的软件本身又可与其他系统(如，局部区域网(LAN))接口连接并通信，存货控制系统、自动诊断收费(charge capture)和记帐系统、医疗记录系统、以及互联网和Web以及其他基于互联网和基于Web的应用网。与智能医疗用品或部件有关的数据也可以由主要设备单元的其他子系统所应用，例如，为了促进及加速主要设备单元半自动的使用前的检查或功能检查。读取器/写入器还可以通过电感地耦合(例如，通过使用天线)或电容地耦合(例如，通过使用从读取器上拾取静电电荷的导电碳素墨水)与RFID标签接口连接。由制造商，例如TI、Motorola、Philips、Mitsubishi、Intermec、Micron和SCS制造的RFID标签可以与本发明一起使用。
在本发明的特定的实施例中，能够存储在标签中的数据的数量足够大，使得每个单个的带有标签的物品具有唯一的、各自的识别号码以及批号。批号可以构成唯一的识别号码的一部分或与其分开。在标签上具有足够的数据存储容量，以当每个单个的带有标签的医疗用品和医疗部件从制造商到病人时为其指定唯一的号码，这使得能够建立提供实时数据的强大的数据库，以提高医疗用品和部件的制造、分配、贮入仓库、重新进货的效率，并减少浪费。
作为一种在产品撤回时的附加措施，被撤回产品的批号和唯一的识别号可以被编程进入相关的医疗设备系统，例如镇静和镇痛供给系统或透析机，或在任何配售地点，如药房、库房和绝对无尘室(cleanroom)。因此，任何污染的药瓶、透析夹头(dialysis cartridge)、被撤回的医疗用品或部件等，当系统匹配被撤回产品的唯一的识别号和批号时，漏掉的撤回都能够自动地识别并被拒绝使用。当有关被撤回产品的具体信息在制造商或管理机构的网页上更新时，被撤换产品的唯一的识别号和/或批号的列表可以从互联网或Web上下载到医疗设备系统，以提供有关被撤回产品的具体信息的全世界范围的、准同时的、和实时的传播。标签在其存储的数据中还包括通信地址，诸如统一资源定位器(Universal Resource Locator)(URL)，其中有关带有标签的产品的更新信息，诸如撤回状态和新近发现的数据，如相反的指示(未与某些药品、病人、环境或状况一起使用)。
本发明还提供医疗主要设备单元上的读取器/写入器，该读取器/写入器在多个标签中选择性地读取，或读取并写入到任何给定的标签上，该多个标签和与主要设备单元结合使用的不同的用后可弃的及可再用的医疗用品和部件有关或与主要设备单元有关。本发明还考虑到一个以上读取器/写入器与主要医疗设备单元一起使用，例如，在使用单个读取器/写入器的实施例的情形中，虽然可以更廉价并更容易地实现，但在从由读取和写入组成的组中选择至少一种功能是很关键的应用中，可能不能提供足够的区域覆盖或冗余度。在另一个实施例中，备用医疗用品和部件可以存放在主要设备单元附近或主要设备单元内，而不会在实际上没有用过的备用品上无意中写上“使用过”的风险。
在本发明的特定的实施例中，识别子系统能够“写”入使用过程中已被污染的并且不再适合以后的病人使用的医疗用品或部件。这些带有标签的物品也可以是与成套器件中的其他医疗用品一起包装。成套器件已集成带有标签的物品，其能够由系统识别和“读取”为质量鉴定过和使用过或未使用过的和“已被写入的”，即曾经由系统使用的，这样，将物品标记为被污染物。这种读取和写入功能可以用这里所描述的许多种方式实现。
对于易受污染的设计为多次使用的物品，可能提供“重写”功能，使物品一旦已被适当地清洁并且已为再使用进行质量鉴定之后能够被重新标记为适于使用。还有，写入功能可能存储关于物品已经经历的使用周期数，并可能将该信息与被推荐的鉴定过的使用寿命周期相比较。这种写入功能可以通过下面描述的多种方式实现。
本发明的读/写系统进一步的结构可以包括读/写装置，而不要求视距(line of sight)、体接触或靠近、相对运动、或扫描，并允许同时读取多个标签并且在有其他多个标签时写入或重写一个特定的标签。更具体地说，根据本发明RFID标签是能经受住压热器作用的(autoclavable)、防尘、防油脂、防刮擦、及防磨损的。可以同时读取或写入一个以上RFID标签。RFID读取器不要求视距读取、也不要求直接接触或相对于标签运动。RFID读取器根据天线的尺寸和功率可以在超过4英尺的距离读取。
在本发明的特定的实施例中，RFID标签10是小(例如，1.8”×1.8”)、薄(例如最大0.015”/最小0.003”)、自粘接标牌，诸如，Texas Instruments公司的电感耦连的Tag-it RFID标牌，该标牌的特征是用户可编程数据为256比特，读取范围为4英尺，频率13.56MHz。这种标签能够被小瓶(例如，异丙酚或其他药品，或任何其他医疗液体的小瓶)或其他用后可弃的或可重复使用的医疗用品或部件上的普通标牌(label)代替。本领域的普通技术人员将会明白，256比特能够产生1.2×1077(即，2256)唯一的ID号码。
如图2中所示，易折断的导电回路20盖覆在或放置在药品或医用液体小瓶22上，该药品或医用液体小瓶包括在该小瓶瓶塞(stopper)上的拉环(pill-tab)。易折断的导电回路用例如导电胶水加在贴到小瓶上的RFID标签24上。指示小瓶内装有何物的普通标牌(label)126可选择地设置在该RFID标签上以将其遮住。当拉环从小瓶22上去掉时，例如当使用者准备用酒精擦去该瓶塞并将其刺穿(spike it)，该导电回路折断。拉环的去除向与该医疗设备相关的RFID读取器/写入器指示，具有折断的导电回路20的小瓶是正被使用的小瓶，从而是应当写成被使用过的小瓶，其中小瓶与该医疗设备一起使用。如果备用的、未使用过的、或未打开过的小瓶也存在RFID读取器/写入器的读取/写入范围内，则它们不被写入为使用过。
本发明的另一方面使用可撕下的或易折断的导电回路以指示产品、成套器件或包装物的使用状态，该导电回路由导电墨水或材料制成或由导电材料如铜制成的微细易折断的导线。例如，如果回路完整无缺，与使用状态的对应的标签中的比特将被设置为1。但是，一旦回路折断(例如，包装被打开或密封破裂之后)，使用状态的比特将设置为0。可折断的导电回路能够被用于，例如，指示紧急复苏成套器件自从其最后被重新存贮或功能测试及鉴定是否已经被使用过，替代当前用于相同功能的机械密封。易折断的导电回路还可以用于组装前的成套器件。易折断的导电回路可以设置在成套器件包装的带胶的边缘周围。当成套器件被打开时，一些形成导电回路的导电墨水或导电材料将附上胶水，并且导电回路将折断。
对于本发的对明成本敏感的应用，只读标签可以与易折断的回路一起使用。因此，状态由导电回路的完整性确定的数据比特将被机械地编程，表示例如产品的使用状态，提供有限的“一次性写入”功能。对于本领域的普通技术人员而言，显而易见，根据导电回路的完整性将数据比特设置为1或0。例如，数据比特可以存储在3.5和5V之间的一个电压来表示1，而存储在0和1.5V之间的一个电压来表示0。通过经导电回路连接控制数据比特状态的销连接器到+5V，该数据比特被拉高(编码为1)，而如果该回路折断，同样的数据比特被拉低(编码为0)。
可选择地，具有导电可折断的回路的RFID标签可以设置在医疗用品或部件上，使得在医疗用品或部件被使用之前导电回路必须被折断。例如，该标签或导电回路可以被设置在异丙酚或其他药品或医疗液体小瓶的瓶塞或拉环的顶部。因此，读取器将能够确定异丙酚或其他药品或医疗液体小瓶中的哪一个真正在使用中以及哪个相应的浓度用于剂量计算和目标控制注射。
易折断的导电回路的状态(完整无缺或被折断)可以用来推断用读/写标签或只读RFID标签标记的医疗或非医疗用品的使用和/或无菌状态(例如，未用过的和消过毒的，或用过的和不干净的)。例如，折断的导电回路通常表示原来装有消过毒的产品的气密封装的使用或无菌状态的丧失。折断的导电回路可能不总是意味着其相关的带有标签的产品的使用。例如，即使拉环已经被折断，还未被刺穿(spiked)的小瓶仍然没有被使用。还是在这个例子中，正被折断的导电回路仍然可能指示在RFID读取器和/或写入器的读和/或写范围内的许多小瓶中的哪个将被使用。
本发明的这种小瓶识别概念也可以用没有易折断导电回路的普通RFID标牌(label)来实现，Texas Instruments公司的Tag-It是一个例子。当使用这种普通的RFID标牌时，在RFID天线读/写范围内的未用过的或备用的小瓶通过将它们放置在金属罩内例如金属匣子内，或通过放置它们在用金属处理的塑料包装内可以与天线屏蔽。可选择地，可以使用具有非常窄范围的RFID天线，特别是用在RFID天线的读和/或写范围不必大的地方，例如，以覆盖多个带有标签的物品。
本领域的普通技术人员将很容易理解，这里公开的RFID标签的利用与是否有易折断的导电回路44与标签连接没有关系。存在着各种保护电可写的带有RFID标签的物品不被无意地重写及被识别为使用过的方法，包括将它们屏蔽在用金属处理的塑料包装内。无线电波不可能透过金属罩并且用金属处理的塑料包装可以实现同样的功能。医疗用品和部件在生产过程中可以放置在用金属处理的塑料包装内以保持它们干净和消过毒，同时还使它们屏蔽无线电波。
如图1和图2所示，自粘贴的RFID标牌通常易卸的并且因此可以被篡改。例如，在用过的医疗用品或部件上的原来的RFID标牌会被去除并用未经认可的RFID标牌替换，该未经认可的RFID标牌虚假地识别医疗用品或部件是“未使用过的”。为了使篡改和不安全的使用更难，本发明考虑用主要设备单元的软件，作为一种手段来证实医疗用品或部件的ID是否被复制并与特定的主要设备单元一起使用过不止一次，其中主要设备单元存储与其一起使用的用于每个医疗用品或部件的单个ID。本发明还考虑使机器或主要设备单元与中央数据库连网，使得如果在该网络中的第二台机器或主要设备单元上使用被复制的ID，那么它仍然能被识别为正在被使用。作为一种附加的防篡改装置，用于每个医疗用品或部件的单个识别号码被加密，并且相应的解密算法位于主要设备单元上或通过互联网或Web可访问的服务器上。篡改还通过在制造期间在医疗用品或部件内嵌入RFID标签来阻止，以使其不可访问或由此对嵌入的标签的物理访问使医疗用品不能用，例如通过在另一个密封系统中形成泄漏。
图3示出识别注射器28(其中注射器是一个根据本发明可以带有标签的物品的例子)中的内含物的标牌(label)36(其中标牌包括RFID标签)。为了识别经注射器手工供给(administer)的药品的成分(identity)和浓度，读-写或只读RFID标签可以结合到目前被用来识别不同注射器中的药品的自粘贴的、颜色编码的标牌中。在每次目前的临床实践中，在抽取每种药品之后颜色编码的标签马上贴到每个注射器上。该RFID标签具有其上编码的数据，例如药品成分、浓度、注射器大小、唯一的ID或批号，以及带有标签的注射器的使用状态。注射器活塞的线性移动通过将磁性墨水或磁性材料放置在活塞最接近的一端的周边上而被跟踪。提供适当的体测量分辨率的一个线性阵列霍尔效应传感器、或间隔开或交错设置以提供体测量的适当分辨率的多个线性阵列的霍尔效应传感器，拾取(pick up)来自磁性墨水或磁性材料的剩余磁场，从而跟踪注射器活塞的线性运动，并从而跟踪在注射器管的截面面积已知时所注射的注射器内含物的体积。RFID标签还可包含药品的成分、药品浓度以及该粘贴有标签的注射器是否以前在另一个病人身上使用过。在注射器带有标签的这样的实施例中，磁性墨水或磁性材料可以沿该注射器28的活塞手柄30的周边设置或放置，即绕使用者的姆指通常放置的地方放置。当药品是由使用者手工注射时，至少一个线性阵列霍尔效应传感器32被采用来跟踪活塞30的线性运动。引导装置34定位并支撑注射器，使得活塞手柄30靠近线性阵列霍尔效应传感器32，并且这样做时确定注射器的大小，以使其截面面积可以被确定。如果霍尔效应传感器的大小超出了所希望的空间跟踪分辨率，那么可以使用一个以上的线性阵列霍尔效应传感器。在这种情况下，这些传感器可以沿着多个线性阵列被交错设置在十分接近活塞手柄30的周边，以便提供所希望的空间跟踪分辨率。
本发明的另一个实施例包括具有易折断的导电回路的RFID标签，被粘贴作为密封容器的RFID密封件，该容器装有非医疗的或医疗的成套器件、医疗用品或部件(例如，用于意识镇静和镇痛的复苏成套器件)、或消过毒的、清洁的、测试的、以及经过鉴定的一些非医疗或医疗设备的部件。该RFID密封件可以存储粘贴有密封件的容器内的内含物的监视的、清洁的或鉴定的日期。可以存储在该密封上的其他数据包括，但不限于，执行手术、清洁、鉴定的人员姓名以及下一次安排的可应用的手术的日期。
图4示出医疗成套器件，该医疗成套器件包含例如，为了一个特定的手术或外科手术所必须的医疗用品和/或部件。该成套器件具有可撕掉的封皮(peel-away cover)40。该封皮具有粘贴到其上的RFID标签42。该RFID标签可以是标牌的形式(如图所示)或非标牌的形式。当在一手术之前撕掉封皮40时，易折断的导电回路44被折断，向RFID读取器和/或写入器指示哪一个成套器件已被打开而应该写入正在被使用。在临床使用中，一个以上的带有RFID标签的医疗成套器件、部件、用品是否可能处于医疗设备系统的RFID读取器和/或写入器的读/写范围内，这是特别重要的。导电路径也可以布置在可撕掉的封皮40的内表面上，使得如果封皮40被切割而不是被撕掉，则该导电路径折断。
本发明提供不需要相关主要设备单元的备用设备的日常检查，(这种设备可以包括复苏的成套器件、所有的合适的紧急医疗装置、成套的部件、部件和用品，例如，自充气的复苏袋、呕吐呼吸机、喉镜、气管内的管、以及药品)它们被放置在用具有易折断导电回路的读/写或只读RFID标签密封的容器内。该容器可以是带匣子的有轮小车或医用箱，其中形式。只要RFID密封件(易折断导电回路)保持完整无缺并且密封的容器的内含物没有超过它们的监视到期日(这可以从编码的RFID标签找到)，使用者可以高度相信管理紧急事件所要求的必要的医疗用品和设备均已到位并且功能正常。备用的设备容器上的RFID标签可以是标牌形式，其包括可撕下来的或易折断的导电回路，当该容器被打开时该导电回路被撕裂或折断。RFID标牌可以选择为自粘贴的。在使用前，容纳有备用紧急成套器件的容器放在其相关的主要设备单元的读取区域内，使得该RFID密封件可以被读取。RFID标签可以含有备用设备的下次监视到期日以及上次监视的到期日或进行上次监视的人员的姓名。因此，与根据本发明的贴标签结合使用的主要设备单元能够自动地通知使用者或临床工程人员成套器件什么时候超过其到期日时以便于再监视及再进货。
在另一个实施例中包含对主要设备单元及其部件进行半自动的使用前检查，RFID密封件或标签的状态被自动地读取。如果密封件折断，表明该成套器件可能已经被使用过，并且物品可能少了(missing)，那么在半自动的使用前检查期间就通过用户接口系统对用户发出这样的警告。使用前检查过程还可以利用带有标签的信息以证实所有所需要的用品和部件已经到位、没有使用过(如果使用前是损害物)、并且没有过期。包括具有根据本发明的易折断的导电元件的标签的密封件构思可以应用于任何领域，在该领域平常很少用的设备在最终需要使用时保证是准备好的并且功能正常的是非常关键的。这里，可应用的领域会包括，但不限于，消防、救援、紧急响应和军事。
如上所述，无源读/写RFID(或合适的备选的电子和/或光学技术)标签可以附加于单个病人使用的(例如，异丙酚或其他药品的小瓶或医用液体小瓶或气体供给电路)或多个病人使用的(例如，监控器具(harness))医疗用品或部件，该医疗用品或部件旨在与特定的主要设备(例如，麻醉机或工作台、透析机、镇静和镇痛供给系统、或X光机)一起使用，该主要设备能够从RFID标签或其他合适的备选的电子和/或光学技术读取和写入。主要设备单元上的读取器/写入器的位置使得当带有标签的医疗用品和部件与主要设备单元结合使用时，粘贴到相关用品和部件上的所有标签将在读取器/写入器装置的的读/写范围内。优选地，但不一定，读取器/写入器位于与医疗用品或部件一起使用且与至少一台或多台控制主要设备单元操作的CPU接口连接的主要设备单元(如，麻醉机、镇静和镇痛机、透析机、X光机)上。可选择地，读取器/写入器可以被连接于(或以无线通信的方式)主要设备单元上但在其之外，以对标签提供最好的覆盖，或结合在手持装置内，例如个人数字辅助装置。仅举例说明，数据比特之一指定为0/1分别表示用后可弃的医用用品或部件的使用过的/未使用过的状态。如果读取器读出该医疗用品或部件以前被使用过(0)，那么警告使用者交叉污染的危险并防止使用以前使用过的医疗物品。
本发明的RFID标签的另一功能是以一种方式证实在外科手术腔中不当心地留下海绵状物体(sponge)或外科器具，这种方式通过对外科手术腔进行X射线照相不会招致所涉及的不想要的时间浪费和用辐射暴露。外科器具和用品可以用用后可弃的RFID标签标记。扫描在手术腔的上方的手持RFID杆或读取器将允许检测被留下的任何带有标签的物体。这种扫描可以在手术腔缝合之前进行。
电子标签还可以用来指示关于连接到其上的物品的使用和存储信息。例如，可用电子标签标记的物品包括但不限于用后可弃的医疗用品或部件，诸如氧气套管、异丙酚瓶、注射药品的泵盒、一组注射管、复苏成套器件、一组ECG垫、以及适合病人使用的耳机，上述用品与序列号为09/324,795的美国专利申请所公开的镇静和镇痛供给系统、麻醉机、麻醉工作台、牙科机、兽医麻醉机、透析机、使用药品的X光机、或其他可再用的系统、可消耗的或用后可弃的用品和部件中的任何一种一起使用。类似地，根据本发明的电子标签可以用来鉴定和识别任何药品、用品、部件或加到医疗设备系统上与其一起使用的附加装置。
图5示出集成电路(“IC”)60(例如，Microchip24C00)的电可擦可编程只读存储器(EEPROM)如何能够嵌入在用后可弃的医疗用品或其他部件62的机器接口连接末端处的塑料模制品中。环形的金属垫58(为了清楚起见其中只一组示于图中)提供与EEPROM上的销电连接。5个环形垫可用于下列功能：串行时钟、串行数据、功率、接地及检测(用于在EEPROM插上电源时检测)，胆是也可以有用更多的或较少的垫来实现本发明的电子标签标记的构思。环形垫58使得与电接头52(例如，Pogo连接器)电连接，这可以是弹簧加载的并且容纳在与EEPROM读取器/写入器53电连接的连接器50内。例如，EEPROM读取器/写入器53可以是基于Motorola的HC 12微控制器。根据本发明的特定的实施例，EEPROM集成电路(例如，Microchip 24C00)被嵌入用后可弃的或可重复使用的医疗用品或部件。编码到EEPROM中的数据由微控制器，例如Motorola的HC12微控制器读取。微控制器也可以写入到EEPROM。环形垫在形成于凸形连接器56的腔中受到保护。凸形连接器56与凹形连接器54配对并且在这样做时在医疗用品或部件和医疗主要设备单元之间提供标定指数(indexing)和电接触。标定指数(或键入)的目的是防止医疗用品或部件以不兼容的方式或取向加到其相关的主要设备单元或装置上。图6和图7示出了连接器的端点示图(end-on view)。本领域的普通技术人也会明白，保证EEPROM和EEPROM读取器/写入器之间的电接触的连接器可以有这些图中未示出的各种其他结构。
反复地将用后可弃的和可再用的用品和部件与主要设备单元连接并断开可以使主要设备单元一侧的连接器磨损因而导致不良的或断续的接触。为了弥补这个问题，本发明在一些实施例中提供将EEPROM通过POGO连接器连接到读取器/写入器的电连接，例如，在连接器54和56上施加机械力以确保良好的电接触。POGO连接器的较昂贵的部件可以放置在主要设备单元一侧上而POGO连接器的不太昂贵的部件可以放置在用后可弃的或可再用的部件上。可选地，本发明可以提供在主要设备单元和其相关的带有标签的部件之间的“中间人”连接器。这种中间人连接器可以数个周期性的间隔时或特定的使用次数之后，明显磨损前被替换。
EEPROM芯片可以被写作“使用过的”，这样能够防止带有标签的用品或部件的再使用以及由此可能的交叉污染。可选择地，当只读或读/写EEPROM与易折断导电回路结合时，只读或读/写EEPROM也可以用来实现能明显看出篡改的密封(tamper-evident seals)。
一次性写入(write-once)的EEPROM芯片可以用作本发明的电子标签，由此一旦将一个芯片被写入为使用过的，它就再也不能以其他任何方式被识别。与医疗用品一起使用的一次性写入的EEPROM在它确实已经被用过的情形下，即使可提供用于写入该EEPROM的加密码和指令，也不能被再写成“未使用过”。因此，一次性写入芯片可以作为一种装置用于防止已使用过的用品被再使用。
为了使用EEPROM标签的物品的安全和有效的使用，EEPROM标签还可以提供其他功能。当能够存储足够比特，例如128比特的EEPROM标签被用作根据本发明的标签时，每个具有这种标签的单个的医疗用品或部件能够被分配一个唯一的ID号和/或加密码。这种在EEPROM标签上的唯一的识别器可以被用来指示医疗用品或部件是来自一个质量合格、经鉴定的、安全的以及真正的源，从而提供一种许可功能。也可以用下述信息进行鉴定：带有标签的医疗用品或部件是否已被测试与它们相关的主要设备单元兼容，或带有标签的医疗用品或部件是否已由管理机构撤回或被禁止使用，以及用品或部件的来源是否合法，即是否许可制造和供给这些用品或部件。一旦该EEPROM标签与主要设备单元的读取器/写入器电接，EEPROM标签也促进医疗用品使用前的检查、诊断收费以及被撤回的医疗用品和部件的使用的防止的半自动化。
可选择地，像信用卡背面的那种磁条也可以用作医疗用品的读/写标签。在本发明的这种实施例中，当磁条移过读取头时读取头实现与磁条的接触。这种移动不需要永久但是不能是零(zero)。当读取头位于主要设备单元上使得带有标签的医疗用品或部件与主要设备单元的物理安装期间标签接触读取头并相对它移动时，可以获得这种移动。同样地，当医疗用品或部件在使用之后从该主要设备单元上去除时，磁条可能也接触读/写头以使其编码数据被改变或其序列号被登记以表明该特定的医疗用品或部件已经被使用过。
根据本发明，可以采用另一种指明使用的机构。例如，物理指示器，诸如受热时改变颜色的热色墨水或“刮-闻(scratch-and-sniff)”涂层，在某些情况下可以被使用以及可以用在带有标签的物品上。还有，备选的电子数据传送机构，举例来说，诸如“蓝牙”，能够在本发明的加标签系统和方法中使用。
图8示出根据本发明的医疗装置或主要设备单元的例子，该医疗装置或主要设备单元结合有与各种带有RFID标签的医疗用品或部件接口连接的RFID读取器/写入器72。嵌入天线(housed antenna)74可以与RFID读取器/写入器72连接。天线74与RFID标签24、82、90、96通信。在与本发明一起使用的医疗装置或主要设备单元70的实施例中，RFID标签将位于嵌入天线74的读/写范围之外，较大的天线76可以通过将诸如金属和导电涂料之类的导电材料的环路放置在医疗装置或主要设备单元的底盘或框架内来实现。放置在医疗设备70的底盘内的较大天线具有比嵌入天线更大的读/写范围。读取器/写入器72与该主要设备单元70的至少一个CPU接口连接，并且该CPU能够选择地与外部处理或数据源接口连接，如，其中，与LAN、WAN、互联网，以及Web接口连接。
如果备用的医疗用品(例如，除了一个正在使用的之外，两个不同浓度的备用异丙酚瓶)存在于读/写范围区内，那么主要设备单元上的读取器/写入器将检测三个异丙酚瓶，但是可能不知道哪个浓度用于异丙酚供给计算或哪个异丙酚瓶应当被写入为“已使用过的”。在这种情况下，存放在可操作地耦连于主要设备单元的读取器/写入器的读/写范围内的备用医疗用品可以被放置在屏蔽RF波的金属外壳内。
关于带有RFID标签的用后可弃的医疗用品和部件被无意地写入为已使用过的之事可以通过将备用的医疗用品和部件放置在金属外壳内来解决，例如放置在图8所示的镀金属的匣子98内，以使该备用的带有RFID标签的医疗用品和部件不受该RFID读取器/写入器的影响。
图8还示出复苏成套器件94，如上面所述，适于包含在该医疗装置或主要设备单元70的使用期间用于管理紧急情况所需要的物品。具有易折断的导电回路的RFID标签用作密封件。当复苏成套器件94打开时导电回路折断。用于保有医疗液体或药品(诸如异丙酚)的小瓶22被示为带有RFID标牌24的标签。小瓶22被钉到用RFID标牌90标记的药箱88上。用后可弃的或可再用的药箱卡在加到医疗装置或主要设备单元上的蠕动的泵机构(peristaltic pump mechanism)(未示出)上。蠕动的泵通过静脉内的线路92将异丙酚或小瓶中的其他内含物供给病人。用后可弃的或可再用的氧气软套管80连接于单元70并用RFID标签82标记。所示的所有的RFID标签设置在RFID读取器/写入器72的读/写范围内。

Claims (20)

1、一种医治系统，用于减轻与医疗或手术过程相关的病人的痛苦、焦虑和不适，所述系统包括病人治疗设备和至少一个医疗用品或医疗部件，所述病人治疗设备包括：
病人健康监视器装置，被耦合至一病人并生成反映该病人的至少一种生理状况的信号；
药物传送控制器，用于将一或多种药物提供给该病人；
存储器装置，用于存储与至少一种被监视的病人生理状况的参数相关的安全信息；及
电子控制器，被互连在该病人健康监视器、药物传送控制器和存储器装置之间；其中所述电子控制器接收所述反映至少一生理状况的信号并根据该信号来管理药物在安全范围内的施加；及
所述系统的特征在于，所述的医疗用品或部件具有数据载体标签，所述设备具有识别装置，用于读取由所述数据载体标签携带的信息并生成反映该携带的信息的信号，且所述存储器装置在其中存储有用于一或多个医疗用品或部件的识别信息，所述标签适于通过所述识别装置将医疗用品或部件识别信息提供给所述存储器装置，供所述病人治疗设备在预使用检查序列中使用，以确保用于所述医疗或手术过程的所述至少一个医疗用品或医疗部件以及至少一个必要的相关部件是存在的和起作用的，及所述标签还适于存储表示所述医疗用品或医疗部件的状态变化的附加信息。
2、根据权利要求1的医治系统，其特征在于，所述医疗用品或部件识别信息包括以下信息中的一或多种：用于给定用品或部件的唯一的ID、一给定用品或部件的识别、一给定用品或部件的来源的识别、包含在一给定用品或部件内的药品的纯度、包含在一给定用品或部件内的药品的浓度、一给定用品或部件以前是否被使用过的状态、一给定用品或部件的批号、一给定用品或部件的制造日期、能够获得的一给定用品或部件的更新的信息的地址、一给定用品或部件的被记录的使用周期数和被推荐的使用周期数、以及一给定用品或部件的到期日期。
3、根据权利要求1的医治系统，其特征在于，所述医疗用品或医疗部件是包含药品的容器并且其中所述标签提供识别所述药品的信息，其中所述医疗用品或医疗部件被容纳在一包中，该包的构成方式和构成材料使得其屏蔽所述标签，从而防止所述携带的信息被更新。
4、根据权利要求3的医治系统，其特征在于，所述标签包括易折断导电元件，所述易折断导电元件使得当易折断导电材料完好时发射第一信号以及所述易折断导电材料被折断后发射第二信号，其中所述标签和所述易折断导电元件被集成到可撕下的标签中，使得撕下所述可撕下的标签导致所述易折断导电元件被折断，所述可撕下的标签被配置成固定在医疗用品或部件箱上，以便提供关于所述箱的内容的信息以及提供关于是否所述箱已被开启的指示器，并且所述医疗用品或部件箱被配置与所述医治系统一起使用。
5、根据权利要求1的医治系统，其特征在于，所述标签是一设置有用于更新所述标签提供的所述附加信息的机械装置的射频标识或电路。
6、根据权利要求1的医治系统，其特征在于，所述医疗用品或部件是包含有多个医疗用品和/或部件的包装，所述包装包括输液泵药品盒，且其中所述标签还提供有关所述包装中的多个所述医疗用品和/或部件的识别信息，所述医疗用品或部件识别信息包括以下信息中的一或多种：用于给定用品或部件的唯一的ID、一给定用品或部件的识别、一给定用品或部件的来源的识别、包含在一给定用品或部件内的药品的纯度、包含在一给定用品或部件内的药品的浓度、一给定用品或部件以前是否被使用过的状态、一给定用品或部件的批号、一给定用品或部件的制造日期、能够获得的一给定用品或部件的更新的信息的地址、一给定用品或部件的被记录的使用周期数和被推荐的使用周期数、以及一给定用品或部件的到期日期。
7、根据权利要求1的医治系统，其特征在于，所述标签包括自由射频识别电路、EEPROM和可读取磁条组成的组中选择的一类型的电子数据发射器。
8、根据权利要求1的医治系统，其特征在于，所述用品或部件包括一机械使用指示器，所述标签包括具有取决于所述机械使用指示器的物理状态的若干值的一数据组，且所述表示状态变化的附加信息和所述数据组可由所述识别装置读取。
9、根据权利要求8的医治系统，其特征在于，所述机械使用指示器包括连接于所述标签的易折断导电回路，其中当所述回路完整无缺时，所述回路指定所述数据组第一值，及当所述回路折断时，所述回路指定所述数据组第二值。
10、根据权利要求9的医治系统，其特征在于，所述易折断导电回路包括施加在一易折断密封件上的导电材料，其中为使用所述医疗用品或部件上而折断所述密封件致使所述导电回路被折断。
11、根据权利要求1的医治系统，其特征在于，由所述标签提供的所述存储的识别信息可经由所述识别装置生成的信号被电子地改变。
12、根据权利要求11的医治系统，其特征在于，所述系统还包括屏蔽区，该屏蔽区防止所述标签当医疗用品或医疗部件被放置在该屏蔽区内时经过由所述识别装置所产生的信号被以电子方式改变。
13、根据权利要求1的医治系统，其特征在于，所述识别装置读取表示所述医疗用品或部件的状态变化的所述附加信息，且所述系统将所述附加信息保留在一数据库中。
14、根据权利要求13的医治系统，其特征在于，所述数据库位于电子连接至所述识别装置的一外部计算机网络。
15、根据权利要求13的医治系统，其特征在于，存储在所述数据库中的表示所述医疗用品或部件的所述状态变化的所述附加信息用于对所述医疗用品或部件的存货跟踪。
16、根据权利要求1的医治系统，其特征在于，所述用品或部件是异丙酚药瓶。
17、根据权利要求1的医治系统，其特征在于，所述用品或部件是输液泵药品盒。
18、根据权利要求1的医治系统，其特征在于，所述用品或部件是一组输液管。
19、根据权利要求1的医治系统，其特征在于，所述用品或部件是氧气套管。
20、根据权利要求1的医治系统，其特征在于，所述识别装置是一电子数据读取器或一电子数据读取器/写入器。
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US7299981B2 (en) 2007-11-27
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