CN104334106A - 用于设备管理的外部读取器 - Google Patents
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Abstract
一种用于跟踪医疗设备的使用的系统,包括电外科发生器、可读模块和读取模块。电外科发生器配置为选择性地将电外科能量信号输送到连接到该电外科发生器的电外科输送设备。可读模块连接到电外科输送设备并且配置为唯一地识别电外科输送设备。读取模块与识别出该读取模块的电外科发生器通信,该读取模块配置为识别可读模块并且还配置为确定电外科输送设备的生命力。如果电外科输送设备是有生命力的设备,则由读取模块启用电外科能量到电外科输送设备的输送。
Description
技术领域
本发明涉及用于执行医疗过程的系统和方法,其中所述系统和方法记录并跟踪单次使用和可重复使用医疗设备的使用情况。
背景技术
电外科器械的使用在本领域中是众所周知的。通过加热组织和血管来凝结、烧灼和/或密封组织,电外科器械通常使用机械夹持动作和电能两者来影响止血。在外科手术过程期间,临床医生可以使用各种电外科器械,诸如像烧灼、凝结/干燥和/或仅仅是减少或减慢外科手术腔内流血的拉长的电外科钳、用于切割或烧灼外科手术切口的电外科笔或解剖刀、包括用于密封和切割血管的末端执行器的致动钳夹构件的电外科血管密封设备。除了临床医生可用的电外科器械的分类之外,许多电外科器械配置为接收各种附件或构件,诸如尖端、钳夹、刀片、电极配置或者其组合。
在外科手术过程期间,临床医生可以采用各种不同的器械,包括可重复使用器械、有限使用的可重复使用器械,以及可抛弃器械。可重复使用器械是其中器械的可重复使用性只受器械的操作性(例如,正确的操作、推荐的维护和/或修复时间表)限制的器械。有限使用的可重复使用器械包括具有有限的有用寿命的器械,其中器械的有用寿命可以基于电激活的次数、电激活的累计时间、机械激活的次数、所执行的外科手术过程的次数或者其任意组合。可抛弃器械是要引入外科手术现场、用于其预期目的并且其后立刻抛弃的器械。
器械还可以配置为接纳可抛弃或有限使用的附件或构件。例如,可重复使用电外科解剖刀可以配置为接纳有限使用或可抛弃的刀片或者有限使用的可重复使用血管密封设备可以配置为接纳可抛弃单次使用的轴和末端执行器或者末端执行器组件或钳夹组件。
制造商的“有限使用”或“可抛弃”推荐通常是基于性能测试、可靠性测试、利用常规消毒技术不能正确地消毒器械或附连构件、作为常规消毒技术的结果的材料降级或者其任意组合。临床医生必须知道使用限制、跟踪实际的使用情况并且通过在实际的使用情况被超过之后抛弃器械来遵守指导。在有些情况下,会存在为了节约成本而重复使用可抛弃器械或者超过推荐的有用寿命还使用产品的诱惑,尤其是在诊所类型的环境或者低收入地区。很显然,当可抛弃器械被重复使用于外科手术目的时或者当器械使用超过其推荐的寿命或周期时,健康问题和顾虑出现。照此,对可重复使用或可抛弃构件的使用推荐有时候依赖于临床医生、外科医生或者外科手术人员在制造商推荐的使用次数被超过之后丢弃器械或构件。
为了帮助临床医生遵守制造商的预期使用和抛弃指导,并且防止器械的故意重复使用,制造商已经采用了多种系统和方法。例如,为了防止偶然的重复使用,有些器械包装成使得该包装在打开时被破坏。其它器械采用智能连接器来防止特定器械与相同电外科发生器的重新连接和重复使用。其它器械采用配置为防止电外科器械在预定时限之后重复使用的超时设备。
本公开内容描述了与现有电外科发生器等对接的设备和系统,以记录并跟踪单次使用和可重复使用医疗设备的使用情况。
发明内容
本公开内容涉及用于跟踪医疗设备的使用的系统,包括配置为选择性地输送电外科能量信号的电外科发生器、配置为连接到电外科发生器并且从其接收电外科能量信号的电外科输送设备、连接到电外科输送设备并且配置为唯一地识别电外科输送设备的可读模块;与电外科发生器通信并且配置为识别读取模块的读取模块,该读取模块配置为识别可读模块并且还配置为确定电外科输送设备的生命力,其中,如果电外科输送设备是有生命力的设备,则读取模块启用电外科能量到电外科输送设备的输送。
该系统的另一方面包括与读取模块通信并且配置为向读取模块提供特定于唯一地识别出的电外科输送设备的信息的设备跟踪和管理系统。基于从设备跟踪和管理系统提供的特定于唯一地识别出的电外科输送设备的信息,读取模块可以确定电外科输送设备的生命力。读取模块可以向设备跟踪和管理系统提供关于电外科发生器的信息。设备跟踪和管理系统可以包括记账模块,该记账模块配置为基于由读取模块提供的关于电外科发生器的信息来生成每次使用账单。设备跟踪和管理系统可以包括库存控制模块,该库存控制模块配置为基于由读取模块提供的关于电外科发生器的信息来维护产品库存。
根据本公开内容的另一方面,可读模块包括条形码,并且读取模块包括配置为识别条形码的扫描仪。可读模块还可以包括射频识别模块,并且读取模块还可以包括配置为识别射频识别模块的扫描仪。
根据本公开内容的其它方面,可读模块包括可读模块无线通信设备,并且读取模块包括配置为与可读模块无线通信设备无线通信的读取模块无线通信设备。可读模块还可以包括当读取模块电连接到存储器时可由读取模块访问的存储器。
附图说明
下面参考附图描述本公开内容的各方面,其中:
图1是根据本公开内容实施例的利用外部使用情况跟踪系统的电外科系统的透视图;
图2A是包装可读模块的透视图;
图2B和2C是通过暴露给周围环境而使其不可操作的包装可读模块的透视图;
图2D是通过分离包装材料的底层和顶层而使其不可操作的包装可读模块的透视图;及
图2E是包装可读模块的透视图,该包装可读模块的一部分在包装材料的底层上形成,并且该可读模块的一部分在包装材料的顶层上形成。
具体实施方式
本文描述本公开内容的具体实施例;但是,应当理解,所公开的实施例仅仅是示例性的并且可以体现为各种形式。因此,本文所公开的特定的结构和功能细节不应当解释为限制,而仅仅是用作权利要求的基础并用作教会本领域技术人员在基本上任何适当的具体结构中采用本公开内容的代表性基础。
在附图中及以下描述中,术语“近端”如其传统意义上一样将指更靠近用户的一端,而术语“远端”将指离用户更远的一端。
一般而言,本文所述的系统和方法关于包括可读模块和一个或多个读取模块以用于防止和/或跟踪可重复使用和/或可抛弃器械的使用的外部使用情况跟踪系统。读取模块与器械关联并且可以结合到和/或附连到器械、器械的包装或者两者。读取模块与每个可读模块对接并且从读取模块接收所关联的器械的一个或多个识别特点。识别特点用来确定器械的生命力,而读取模块把器械的生命力提供给与器械互连和/或对接的系统。器械的生命力可以与系统的兼容性和/或连接性有关、与之前的使用有关、与到期日期和/或时间帧有关、或者与任何其它合适的测量或标准有关。
现在参考图1,根据本公开内容实施例的用于为医疗过程提供电外科能量的电外科系统示为10,该系统包括外部使用情况跟踪系统100。电外科系统10包括电外科发生器20、配置为经传输线34耦合到电外科发生器20的输送设备30以及外部使用情况跟踪系统100。
提供了电外科系统10并且被描述为证明外部使用情况跟踪系统100的使用和特征。这个具体的例子不应当认为是限制。外部使用情况跟踪系统100可以与使用可抛弃和/或有限使用部件的任何系统一起使用,诸如像使用可抛弃末端执行器的系统(例如,射频系统、微波系统和/或超声系统),以及使用可抛弃盒(cartridge)的系统(动力吻合器(power-stapler)、打印机、复印机、动力射钉驱动器(power nail driver)和/或CO2盒致动的设备)。
电外科发生器20可以包括操作人员接口40,具有用于输入关于电外科发生器20、输送系统30的参数和/或关于其操作的参数的键区42。显示器44可以指示或绘出关于外科手术过程、电外科发生器20、传输线34和/或输送设备30和/或外部使用情况跟踪系统100的一个或多个参数。电外科发生器20包括用于控制电外科发生器20的操作的中央处理单元和控制电路(未明确示出)。
输送设备30可以是任何合适的电外科输送设备,诸如像射频、微波和/或超声消融设备、组织密封设备或者其它电外科组织治疗设备,或者输送设备30可以是部件输送设备,诸如动力吻合器、动力射钉驱动器、打印机或复印机。输送设备30可以是单次使用的可抛弃设备、多次使用的可抛弃设备或者有限使用的可重复使用设备。
传输线34可以是同轴电缆(例如,波导)、多导体电缆或者任何其它合适的电缆或者其组合,以用于传输电外科能量信号和/或电外科控制信号。位于传输线34的近端的连接器24耦合到电外科发生器20上的传输线接收器46。传输线34的远端连接到输送设备30的手柄36。
外部使用情况跟踪系统100包括读取模块110、一个或多个可读模块120以及远程定位的设备跟踪和管理系统115。如下所述,外部使用情况跟踪系统100的各种部件写作,以跟踪并记录每个具体的输送设备30的使用情况。
如图1中所说明的,读取模块110通过读取模块电缆112直接连接到电外科发生器20。读取模块电缆112可以直接连接到电外科发生器20中先前存在的通信端口46b,并且可以使用任何合适的通信协议与电外科发生器20通信。或者,读取模块110可以连接到电外科发生器20上的模拟或数字输入端口,并且可以提供模拟或数字信号,其中该模拟或数字信号提供关于或者来自外部使用情况跟踪系统100的信息和/或数据。一种合适的通信协议可以包括无线协议(例如,Wi-Fi、蓝牙、ZigBee或者其它合适的无线通信协议),其中读取模块110无线地连接到电外科发生器20。
在有些实施例中,读取模块110是配置为执行与外部使用情况跟踪系统100有关的一个或多个应用的智能设备。这一个或多个应用可以关于控制容纳在读取模块100中并且配置为读取/识别由可读模块120形成的可读代码的扫描仪。例如,一个应用可以控制配置为识别/读取可读代码的光学读取设备(例如,照相机/条形码扫描仪)。可读代码可以是一维条形码、二维条形码或者任何光学可区分和/或可识别的图案。可读代码和条形码在本文中可互换使用。除了与设备跟踪和管理系统115通信之外,读取模块110还可以包括配置为与个别读取模块110通信的应用,由此在多个读取模块110之间形成本地化的网络。在有些实施例中,读取模块110是无线手枪式握把读取器。
在另一种实施例中,本文所述的读取模块110的功能结合到新电外科发生器20的电路系统中。照此,在附图中说明并且在本文中描述的电外科发生器20、输送设备30和外部使用情况跟踪系统100以及各种部件之间的交互的详情可以在电外科发生器20、输送设备30以及外部使用情况跟踪系统100的其它部件之间分布。照此,本文所述的系统和方法仅仅是作为例子提供的,并且不应当认为是限制。
读取模块110配置为与和特定输送设备30关联的一个或多个可读模块120对接。可读模块120被读取模块110读取和/或检测,并且可以包括任何合适的可读和/或可检测技术。例如,可读模块120可以包括可读的识别码,诸如像一维条形码120a、二维条形码120b或者任何其它合适的可读识别图案、设备或编码。
可读模块120还可以包括硬连线的可读技术,诸如像EEPROM、微控制器或者智能卡120e。读取模块110可以通过合适的电缆(未明确示出)连接到可读模块120,或者可读模块(例如,智能卡120e)可以从输送设备30除去并连接到读取模块110。与输送设备30有关的信息经可读模块(例如,智能卡120e)在读取模块110和可读模块120之间传送。
可读模块120还可以经无线通信系统(例如,无线发送器/接收器120c)连接到读取模块110。无线发送器/接收器120c可以通过任何合适的低功率无线数字通信协议,诸如像蓝牙或ZigBee来连接。当输送设备30位于读取模块110附近时,读取模块110可以配置为利用无线发送器/接收器120c自动检测输送设备30。或者,无线连接可以由临床医生手动启动。
可读模块120还可以经可检测的技术,诸如像射频识别设备(RFID)120d,连接到读取模块110。在输送设备30位于读取模块110附近之后,读取模块110可以检测位于输送设备30上(或其中)的可读RFID模块120d。连接到输送设备30的可读RFID模块120d可以被读取模块110自动检测,或者其检测可以由临床医生手动启动。
在使用当中,读取模块110从位于特定输送设备30上或者位于容纳输送设备30的包装材料130上的一个或多个可读模块120a-120e接收识别信息。读取模块110经直接或间接连接(例如,wi-fi或无线连接)连接到设备跟踪和管理系统115并且向其提供识别信息。
设备跟踪和管理系统115利用识别信息来定位关于特定输送设备30的跟踪和使用情况信息。跟踪和使用情况信息用来确定特定的输送设备30是否是有生命力的设备(例如,可重复使用的和/或未用的设备)、兼容的设备(例如,与特定的电外科发生器20兼容)和/或对使用来说安全的设备(例如,没有制造召回)。确定步骤可以由设备跟踪和管理系统115、读取模块110、电外科发生器20或者其任意组合来执行。
新信息(或者对现有信息的改变)可以关于电外科发生器20与特定的输送设备30的一起使用。在输送设备30被使用之前、期间和/或之后,新信息或者对现有信息的改变可以添加到设备跟踪和管理系统115中对应的记录。该信息可以包括加时间戳的信息,关于电外科发生器、读取模块110和可读模块120的信息,关于外科手术过程的信息(例如,类型、持续时间等),关于性能和/或所输送能量的信息以及关于用户和/或设施的信息(例如,操作人员输入的设施代码或位置代码)。
设备跟踪和管理系统115跟踪特定输送设备30的一个或多个方面。例如,设备跟踪和管理系统115可以跟踪单次使用的输送设备的使用情况,并且还可以防止单次使用的输送设备30的重复使用。设备跟踪和管理系统115还可以跟踪特定的可重复使用输送设备30的使用和重复使用,并且如果确定特定的使用是不安全的或者不被允许的就可以防止特定可重复使用输送设备30的重复使用。设备跟踪和管理系统115在制造期间或之后识别每个特定的输送设备30、把可读设备120与特定的输送设备30关联、贯穿其可用寿命跟踪每个特定的输送设备30,并且在可用寿命到期之后防止重复使用。
设备跟踪和管理系统115还可以配置为包括企业资源规划系统的功能。例如,设备跟踪和管理系统115的部件可以包括用于跟踪和控制特定办公室、医院和/或其中特定存储位置的库存的库存控制模块115a。设备跟踪和管理系统115的库存控制模块115a可以基于使用情况和/或可用性自动地生成订单或者可以基于历史使用情况提供订单建议。
设备跟踪和管理系统115还可以包括提供消毒监视和跟踪的消毒控制模块115b。在有些实施例中,设备跟踪和管理系统115的消毒控制模块115b跟踪、记录和/或监视每次个别使用和在每次使用之后发生的后续消毒。如果时间戳信息指示消毒没有执行、以高度可能性指示消毒没有适当地执行或者指示消毒完全被绕过了,则设备跟踪和管理系统115可以防止特定的输送设备30重新进入库存系统。例如,来自电外科发生器20的时间戳信息可以指示特定的输送设备30在所指示的使用之后直接重新导入库存,由此指示消毒没有执行。
设备跟踪和管理系统115还可以包括生成自动化的客户记账(对于单次使用输送设备和/或有限使用的可重复使用输送设备)和/或自动化的患者记账(对于单次使用设备、每次使用付费的设备和/或为每次使用付费或可重复使用的设备分裂记账)的记账模块115c。例如,在外科手术过程中,读取模块110识别特定的输送设备30并且把其使用报告给设备跟踪和管理系统115。如果特定的输送设备30是单次使用设备,则库存控制模块115a将指示重新订购新的输送设备,并且记账模块115c将启动对输送设备30的使用的适当的患者记账。如果特定的输送设备30是有限使用的可重复使用设备,那么,如果使用跟踪指示输送设备30已经过期并且输送设备30不能再重复使用,则库存控制模块115a可以启动输送设备30的重新订购。记账模块115c对输送设备30的所分配的使用百分比生成适当的患者记账,并且订购可以由库存控制模块115a启动。
外部使用跟踪系统100配置为与控制电外科发生器20的操作的电外科控制算法对接。在有些实施例中,现有电外科发生器20中的电外科控制算法被重新编程为通过之前存在的通信端口46b连接到读取模块110。照此,外部使用情况跟踪系统100的实现可以通过在现有电外科发生器20中实现电外科控制算法的软件升级并且把读取模块110连接到电外科发生器20来达成。
新的电外科发生器可以配置为通过任何合适的无线个人区域网络(WPAN),诸如像蓝牙、红外线或WiFi,连接到外部使用情况跟踪系统100的读取模块110,因此需要最小化的改变来实现外部使用情况跟踪系统100。
从读取模块110提供给电外科发生器20的信息可以包括关于输送设备30的制造、组装和测试的信息,关于输送设备30的使用的信息和/或关于输送设备30与电外科发生器20的兼容性的信息。信息还可以关于输送设备30的安全操作,并且可以包括安全操作过程、产品召回信息和/或关于输送设备30和/或在制造输送设备30之后获得的用于制造输送设备30的材料的信息。
外部使用情况跟踪系统100可以为读取模块110提供关于特定输送设备30的产品性能信息,诸如输送设备30的规格与测试数据。如可以理解的,特定输送设备30被外部使用情况跟踪系统100的识别提供了提供关于特定输送设备30的最新信息的能力。
在另一种实施例中,从读取模块110提供给电外科发生器20的信息可以局限于在读取模块110和/或设备跟踪和管理系统115(或者其任何部件)确定特定输送设备30是否到期时启用和/或禁用。读取模块110向电外科发生器20提供启用/禁用信号,其中提供启用信号指示输送设备30是有生命力的设备(例如,未用的和/或能够被重复使用的)、兼容设备、未过期的设备和/或其任意组合。启用信号可以启用电外科能量到输送设备30的输送。
新输送设备平台可以包括设计成与新电外科发生器连接并对接的新特征。照此,新输送设备平台与早一代的电外科发生器20不兼容。例如,新输送设备平台可以包括关于没有包括在早一代电外科发生器中的外部使用情况跟踪系统100的特征。照此,读取模块110可以配置为与包括在新输送设备平台中的特征(例如,无线通信发送器/接收器120c,如以下将更详细讨论的)对接。照此,通过经读取模块110与早一代的电外科发生器20对接,具有早一代电外科发生器20的电外科系统100可以使用在新输送设备30中提供的或者与新输送设备30一起提供的新平台特征。
返回图1,输送设备30配置为与外部使用情况跟踪系统100对接。输送设备30包括配置为与可读模块110对接的多个可读模块120。图1说明了几个可读模块120,但是可以使用少至一个可读模块120。
在有些实施例中,读取模块120结合到包装材料130中(例如,在软包装130中形成的一维条形码120a)、结合到在传输线34的近端上的连接器24中(例如,二维条形码120b)、结合到输送设备30的手柄36中(例如,RFID 120d或者无线通信发送器/接收器120c)或者其任意组合。
输送设备30可以包括可读RFID模块120d。可读RFID模块120d可以附连到输送设备30的外部(例如,在外罩36上),如图1中所说明的,或者可读RFID模块120d可以位于由外罩36形成的内部腔体中。可读RFID模块120d以及外部使用情况跟踪系统100的操作可以独立于输送设备30的操作。照此,可读RFID模块120d可以附连到现有的设备(例如,在外部定位的),或者在组装过程期间结合到输送设备30中(例如,在内部或外部定位的)中。
在另一种实施例中,输送设备30的内部电路系统包括可读RFID电路系统(未明确示出)。内部电路系统可以提供关于输送设备30的使用的数据,并且把该数据发送到可读RFID电路系统(未明确示出),并且可读RFID电路系统把关于输送设备30的使用的数据的至少一部分提供给外部使用情况跟踪系统100的读取模块110。
在使用当中,当把读取模块110放在可读RFID模块120d附近合适的位置时,读取模块110从可读RFID模块120d接收信息。该信息可以包括直接识别输送设备30或者通过可读RFID模块120d的识别来间接识别输送设备30的识别信息。该信息可以把读取模块110指向包含输送设备30的识别和/或使用信息的表、数据库或其它数据存储位置。例如,在有些实施例中,读取模块110接收关于可读RFID模块120d的识别信息,该识别信息把读取模块110指向包含关于特定输送设备30的信息的数据库条目。读取模块110可以确定输送设备30与电外科发生器20之间的兼容性,由此防止不兼容的输送设备30的使用。读取模块110还可以确定输送设备30是否之前已经使用过,由此防止可抛弃产品的重复使用。此外,读取模块110可以确定有限使用的可重复使用输送设备30的使用是否已经超过最大使用次数,由此防止有限使用的可重复使用产品的过度使用。
在检测到可读RFID模块120d之后,读取模块110可以验证输送设备30和电外科发生器20之间的兼容性,然后可以确定关于输送设备30的各种使用参数,并且提供信号,以启用或禁用电外科发生器20与识别出的输送设备30的一起使用。
在有些实施例中,可读RFID模块120d可以连接到输送设备30的能量输送部分或控制部分,使得当输送设备30连接到电外科发生器20或者从其接收电外科能量时,可读RFID模块120d不能被输送设备30操作或者不能被其重复使用。例如,输送设备30可以更改存储在可读RFID模块120d中的信息,或者更改可读RFID模块120d的操作,使得重复使用附连有可读RFID模块120d的输送设备30的任何尝试都将导致外部使用情况跟踪系统100检测到之前的使用,由此阻止输送设备30的重复使用。
可读RFID模块120d还容易受消毒过程的一个或多个方面的影响。暴露给消毒过程更改存储在可读RFID模块120d中的信息或者消毒过程使可读RFID模块120d不可操作。例如,可读RFID模块120d可以对热量、流体、电磁辐射和/或暴露给与消毒过程有关的其它条件敏感,使得重复使用具有已经暴露给消毒过程的可读RFID模块120d的输送设备30的任何尝试都将导致被外部使用情况跟踪系统100检测到。
利用关于本文所讨论的可读模块120b-120e的功能,包装可读模块120a可以结合到包装材料(例如,软包装130)中。包装可读模块120a可以作为位于输送设备30上的可读模块120a-120e的备选来提供,或者可以在一个或多个可读模块120a-120e之外另外提供。
在另一种实施例中,位于包装材料(例如,软包装130)上的包装可读模块120a对应于与输送设备30关联的可读模块120b-120e。在启用电外科发生器20的操作之前,读取模块110必须识别出包装可读模块120a和位于输送设备30上的对应的可读模块120b-120e。
包装可读模块120a可以包括结合到包装材料(例如,软包装130)中的一维条形码,如图1中所说明的。在打开包装材料(例如,软包装130)之前,包装可读模块120a可以被读取模块110经过一层或多层包装材料(例如,软包装130)访问。包装可读模块120a位于包装材料(例如,软包装130)上,使得在包装材料(例如,软包装130)被打开之后包装可读模块120a被破坏或者变得不可读。
本文所述并且在附图中说明的包装、包装材料和包装技术不应当认为是限制,因为本文所提供的示教可以与其它合适的外科包装一起使用或者结合到其中。软包装130包括通过粘合剂密封132连接到一起的柔性底层130a和柔性顶层130b,由此在其间形成无菌的内部囊袋143。沿着第一、第二和第三边缘131a-131c沿柔性底层130a和柔性顶层130b的边缘定位的粘合剂密封132把底层130a结合到顶层130b。粘合剂密封132的位置(例如,从第四边缘131d插入)提供了对软包装130的个别层(例如,柔性底层130a和柔性顶层130b)的访问。与第一、第二和第三边缘131a-131c相邻形成的粘合剂密封132防止柔性底层和顶层130a和130b的分离。
位于第四边缘131d和粘合剂密封132之间的读取模块120a附连到柔性顶层和底层130a和130b,并且可以被读取模块110通过柔性底层130a和/或柔性顶层130b读取。软包装130通过分离柔性顶层和底层130a和130b而被打开,由此沿着第四边缘131d拆开粘合剂密封132。进一步分离柔性顶层和底层130a和130b沿着第一和第二边缘131a和131b拆开粘合剂密封132的至少一部分。
沿着第四边缘131d位于柔性底层和顶层130a和130b之间的可读模块120a包括可读模块120a与底层和顶层130a和130b当中每一个之间的结合。这种结合可以比用来构造可读模块120a的材料更强。例如,可读模块120a可以通过粘合剂层131粘合性地附连到底层和顶层130a和130b。可读模块120a与底层和顶层130a和130b当中每一个之间的结合可以足够强,使得分离底层和顶层使可读模块120a不起作用(例如,不能被读取模块110读取和/或不可被其识别)。
在另一种实施例中,可读模块120a是通过把底层和顶层130a和130b结合到一起而形成的。如图2D中所说明的,底层和顶层130a和130b熔合到一起,由此在其间形成单个层。照此,打开软包装需要破坏底层和顶层130a和130b之间的结合,由此使可读模块120a不可读(例如,由此撕开这两层和/或拉伸这两层,由此使代码不可读)。
在另一种实施例中,底层和顶层130a和130b在可读模块120a周围形成液密密封,由此隔离可读模块120a与周围环境。打开软包装130(例如,除去输送设备30)把可读模块120a暴露给周围环境,由此使可读模块120a不起作用和/或不可读。例如,可读模块120a可以用在暴露给周围环境时蒸发的蒸发性材料打印,如图2B中所说明的。或者,如图2C中所说明的,可读模块120a可以包括修改条形码图案的反应性材料(例如,如图2B中所说明的那样,通过消除图案的一部分或者如图2C中所说明的那样,通过给图案添加附加部分来改变条形码的图案),由此使条形码不可读。
在有些实施例中,反应性材料构成可读代码的至少一部分,并且反应性材料与空气中的一种或多种成分起反应。例如,可读代码可以利用百里酚酞(thymolphthalein)和基体材料的溶液形成,然后密封在底层和顶层130a和130b之间。当被打开时,基体与二氧化碳反应,二氧化碳在空气中总是存在的,由此把pH值降至可读代码消失的水平,从而使包装可读操作不可操作。
在另一种实施例中,可读代码背景(background)的至少一部分是利用在暴露给周围环境时变暗(例如,与空气和/或空气中存在的氧化物反应)的溶液形成的,由此修改可读代码的结构并且使包装可读材料不可操作。
在还有另一种实施例中,可读模块120a的第一部分在底层130a上形成,并且可读模块120a的第二部分在顶层130b上形成,如图2E中所说明的。底层120a与顶层130b的分离使可读模块120a不可读。
其它外科器械包装布置可以包括半壳包装。半壳器械包装包括包含用于接纳外科器械的至少一个腔体的刚性或半刚性底部半壳组件以及配置为覆盖该腔体的柔性盖子部分。半壳器械包装还可以包括多个隔开的腔体,用于在实现的每一端选择性地电镀保护性插头,使得一个包装腔体可以用于多个变化尺寸的器械。半壳组件通常包括凸缘区域,柔性盖子部分粘合性地附连到该区域之上,由此在其间形成无菌腔体。
可读模块可以结合到半壳包装中,使得柔性盖子部分与底部半壳组件的分离使可读模块不可读。
还有另一种外科器械包装布置包括全壳器械包装。全壳器械包装包括在多个位置连接的刚性顶部和底部,由此在其间形成用于输送设备的无菌腔体。这种类型的包装可以是单次使用的包装或者可以是可重新密封并且因此可重复使用的。
在另一种实施例中,可重复使用的输送设备30包括提供关于特定输送设备30的信息的两个可读模块120。第一可读模块(例如,包装可读模块120a)在包装材料(例如,软包装130)中形成,并且第二可读模块(例如,可读模块120b-120e之一)连接到可重复使用输送设备30。
在制造和包装过程期间,第一可读模块和第二可读模块具有识别容纳在包装材料中的特定可重复使用输送设备30的识别信息。
可重复使用输送设备30的全部使用包括第一次使用以及有限次数的后续可允许的重复使用,其中最后(final)可允许的使用是最后一次(last)可允许的使用。
在有些实施例中,在第一次使用期间,临床医生需要通过利用外部使用情况跟踪系统100的读取模块110读取/扫描第一可读模块120a和第二可读模块120b-120e来识别输送设备30。外部使用情况跟踪系统100确定输送设备30之前还没有被使用过,并且由此把该使用识别为第一次使用。
外部使用情况跟踪系统100可以指示关于第一次使用的识别特征,该特征进一步限制输送设备30的后续重复使用。例如,读取模块110可以提供附连到特定输送设备30的识别信息的位置指示器。该位置指示器可以识别外科设施、可以识别客户标识符、可以识别记账实体或关于输送设备30的特定用户的任何其它信息。位置指示器还可以把特定输送设备30的使用限定到与该位置指示器有关的系统和设备。
在另一种实施例中,包装材料130可以配置为对输送设备30重复使用。照此,在后续可允许的使用之前,每次后续可允许的使用都会要求第一可读模块120a和第二可读模块120b-120e的扫描/读取。输送设备30可以一直被重复使用,直到外部使用情况跟踪系统100确定当前使用是最后一次使用并且其后输送设备30将不可用。重复使用输送设备30的任何后续尝试都将不被外部使用情况跟踪系统100允许。
在另一种实施例中,包装材料130不可重复使用并且要在第一次使用之后被丢弃。照此,每次后续的可允许使用只需要第二可读模块120b-120e的扫描/读取。输送设备30可以一直被重复使用,直到外部使用情况跟踪系统100确定当前使用是最后一次使用并且其后输送设备30将不可用。重复使用输送设备30的任何后续尝试都将不被外部使用情况跟踪系统100允许。
第一可读模块120a的后续扫描将指示不预期被重复使用的包装材料130被重复使用并且可以指示不正确的消毒过程。输送设备30的重复使用可以被禁止或阻止。或者,在后续可允许的使用时对第一可读模块120a的再次扫描可以生成正确的消毒过程没有在识别出的位置执行或者被识别出的用户执行的指示器或警报。
在还有另一种实施例中,如本文所述的外部使用情况跟踪系统100结合到消毒系统中。例如,如图1中所说明的,电外科系统20可以是如上文中所讨论的,对输送设备消毒并且使输送设备准备好用于后续使用的消毒系统20。消毒系统20直接地或者通过读取模块120间接地向设备跟踪和管理系统115提供关于输送设备的消毒的信息。
虽然本公开内容的几个方面已经在附图中示出,但是本公开内容不是要局限于此,因为预期本公开内容的范围如本领域中将允许的那样广泛并且该说明书也要同样地阅读。因此,以上描述不应当认为是限制,而仅仅是作为特定方面的示例。本领域技术人员将预想到在所附权利要求范围与主旨内的其它修改。
Claims (14)
1.一种用于跟踪医疗设备的使用的系统,包括:
电外科发生器,配置为选择性地输送电外科能量信号;
电外科输送设备,配置为连接到电外科发生器并且从其接收电外科能量信号;
可读模块,连接到电外科输送设备并且配置为唯一地识别电外科输送设备;及
读取模块,与识别出该读取模块的电外科发生器通信,该读取模块配置为识别可读模块并且还配置为确定电外科输送设备的生命力;
其中,如果该电外科输送设备是有生命力的设备,则由读取模块启用电外科能量到电外科输送设备的输送。
2.如权利要求1所述的系统,还包括:
设备跟踪和管理系统,与读取模块通信并且配置为向读取模块提供特定于唯一地识别出的电外科输送设备的信息,
其中,基于从设备跟踪和管理系统提供的特定于唯一地识别出的电外科输送设备的信息,读取模块确定电外科输送设备的生命力。
3.如权利要求2所述的系统,其中,读取模块向设备跟踪和管理系统提供关于电外科发生器的信息。
4.如权利要求3所述的系统,其中,设备跟踪和管理系统包括记账模块,该记账模块配置为基于由读取模块提供的关于电外科发生器的信息来生成每次使用账单。
5.如权利要求3所述的系统,其中,设备跟踪和管理系统包括库存控制模块,该库存控制模块配置为基于由读取模块提供的关于电外科发生器的信息来维护产品库存。
6.如权利要求1所述的系统,其中,可读模块包括条形码,并且读取模块包括配置为识别条形码的扫描仪。
7.如权利要求1所述的系统,其中,可读模块包括射频识别模块,并且读取模块包括配置为识别射频识别模块的扫描仪。
8.如权利要求1所述的系统,其中,可读模块包括可读模块无线通信设备,并且读取模块包括配置为与可读模块无线通信设备无线通信的读取模块无线通信设备。
9.如权利要求1所述的系统,其中,可读模块包括存储器,该存储器在读取模块电连接到该存储器时能由读取模块访问。
10.一种用于启用电外科能量到医疗设备的输送的方法,包括以下步骤:
提供包括可读模块的电外科输送设备,该可读模块唯一地识别电外科输送设备;
提供与电外科发生器通信的读取模块,其中电外科发生器选择性地将电外科能量输送到电外科输送设备;
通过利用读取模块从可读模块读取唯一的身份信息,识别电外科输送设备的唯一身份;
确定电外科输送设备是否能够与电外科发生器一起使用;及
如果电外科输送设备能够与电外科发生器一起使用,则启用电外科能量从电外科发生器到电外科输送设备的输送。
11.如权利要求10所述的方法,还包括以下步骤:
提供与读取模块通信并且配置为向读取模块提供特定于唯一地识别出的电外科输送设备的信息的设备跟踪和管理系统,
其中,读取模块基于从设备跟踪和管理系统提供的特定于唯一地识别出的电外科输送设备的信息来确定电外科输送设备的生命力。
12.如权利要求11所述的方法,还包括以下步骤:
基于由读取模块提供的关于电外科发生器的信息来生成每次使用账单。
13.如权利要求11所述的方法,其中,电外科输送设备是单次使用的可抛弃电外科输送设备,该方法还包括以下步骤:
跟踪单次使用的可抛弃电外科输送设备的使用情况;及
如果设备跟踪和管理系统指示已经发生过之前的使用,则阻止该单次使用的可抛弃电外科输送设备的重复使用。
14.如权利要求11所述的方法,其中,电外科输送设备是有限使用的可重复使用电外科输送设备,该方法还包括步骤:
跟踪有限使用的可重复使用电外科输送设备的使用情况;及
如果设备跟踪和管理系统指示进一步的使用不被允许,则阻止该有限使用的可重复使用电外科输送设备的重复使用。
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CA2868823A1 (en) | 2013-11-07 |
JP2015520629A (ja) | 2015-07-23 |
EP2844174B1 (en) | 2019-06-05 |
US9763725B2 (en) | 2017-09-19 |
US20130293353A1 (en) | 2013-11-07 |
JP6195907B2 (ja) | 2017-09-13 |
CN104334106B (zh) | 2017-09-01 |
US20160038217A1 (en) | 2016-02-11 |
EP2844174A1 (en) | 2015-03-11 |
US9204920B2 (en) | 2015-12-08 |
AU2013256795A1 (en) | 2014-10-09 |
WO2013165683A1 (en) | 2013-11-07 |
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