CN111714065A - 内窥镜仪器及确保内窥镜的使用合乎规则的方法 - Google Patents
内窥镜仪器及确保内窥镜的使用合乎规则的方法 Download PDFInfo
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Abstract
一种内窥镜仪器。内窥镜仪器包括内窥镜;识别装置,用以识别内窥镜;确认装置,用以根据识别装置识别的结果判断内窥镜是否适用于特定医疗行为;及失能装置,用以当确定内窥镜不适用于特定医疗行为时,禁止使用内窥镜。
Description
技术领域
本发明公开了一种用于医疗行为内窥镜仪器,特别是一种具有使用限制的内窥镜仪器。
背景技术
具有使用限制的内窥镜仪器主要目的是限制可能接触人体组织的内窥镜部件的使用来降低成本并增加对患者的安全性。这简化了灭菌的需要并降低了传染风险。然而,目前市面上产品的限制机制有限,所以需要新的机制以确保内窥镜被使用在正确医疗行为上。
发明内容
本发明提供一种内窥镜仪器。内窥镜仪器包括内窥镜;识别装置,用以识别内窥镜;确认装置,用以根据识别装置识别的结果判断内窥镜是否适用于特定医疗行为;及失能装置,用以当确定内窥镜不适用于特定医疗行为时,禁止使用内窥镜。
本发明提供一种确保内窥镜的使用合乎规则的方法。方法包括给予所述内窥镜识别装置;根据识别所述识别装置的结果判断所述内窥镜是否适用于特定医疗行为;及当确定所述内窥镜不适用于所述特定医疗行为时,禁止使用所述内窥镜。
附图说明
图1为实施例的内窥镜仪器的示意图。
图2为输入到内窥镜的内部存储器的产品识别码及/或序号的示例格式。
图3为本发明内窥镜仪器的使用流程图。
其中,附图标记说明如下:
100 内窥镜容器
101 标签
102 内窥镜
103 通信应用程序编程接口
104 存储器
105 套管
200 授权软件
201 设备通信应用程序编程接口
202 云通信应用程序编程接口
203 视化软件连接
204 本地数据库
300 云数据库
301 软件识别码
302 产品识别码
303 序号
304 散列算法
400 扫描器
401 硬件通信应用程序编程接口
402 软件通信应用程序编程接口
500 流程图
510至580 步骤
具体实施方式
新型一次性医疗内窥镜使从业者能够进行更安全,更合乎规定的检查。由于这样的系统不需要消毒(或者仅需要部分消毒),或者可以检测到先前使用过元件并且不应该重复使用,因此可以使内窥镜检查更为安全。此外,通过这些新设计可确认某些元件不应被使用,例如,到期的元件、召回的元件、无效授权许可及/或不正确的医疗程序等。此机制可以使内窥镜被用在更符合需求的检查。
具有使用限制的内窥镜仪器提供优于传统可重复使用的内窥镜仪器的许多益处,包括但不限于成本,易用性,尺寸,患者舒适度和简化的消毒过程。然而,确保这种新一代仪器的安全和合规使用取决于确保这种仪器的一次性部件有使用限制。这些限制包括确认内窥镜的某些可拆卸部分对于特定医疗行为的适用性,限制一次性内窥镜的某些部件的重复使用,禁止一次性内窥镜的某些部件的不当使用及/或确保灭菌包装的可追溯性。
图1为实施例的内窥镜仪器的功能示意图。内窥镜容器100包括标签101及内窥镜102。内窥镜102包括通信应用程序编程接口(Communication API)103及存储器104。存储器104可为一种非易失性只读存储器,例如可编程只读存储器(PROM)或一次性可编程非易失性存储器。
识别内窥镜102的信息可以存储在容器100上(通过标签101)及/或存储在内窥镜仪器的存储器104中,使内窥镜102启用之前可进行双重验证。若验证软件仅验证容器100,则可以多个内窥镜102可与同一容器100的标签101一同启用。另一方面,若只有内窥镜102有标签,这可能使所提取的内窥镜102用于不适用的医疗行为。
在容器100及内窥镜102上分别设置设备信息还允许激活软件追踪哪个容器及何种特定的内窥镜被启用。例如,在内窥镜102的某些部件可以被回收的情况下或者在部件内有样品的情况下,内窥镜102需要进一步被送到实验室分析。最后,通过使用双重标签,我们可以验证容器100的标签以确认内窥镜102是否为对应于适合容器100的内窥镜。标签101可以与容器100及内窥镜102相关,或者每个容器100及内窥镜102都具有一标签。
图1的内窥镜解决方案可包括授权软件200,其包括设备通信应用程序编程接口201,云通信应用程序编程接口202,视化软件连接203及本地数据库204。
在仪器制造期间,授权软件200用于为内窥镜提供序号及/或产品识别码。产品识别码可识别内窥镜类别(例如,针对泌尿科所使用的内窥镜)。授权软件200与序号对应并可被编程在内窥镜固件内。
当未授权的内窥镜连接到授权软件200时,可以使用设备通信应用程序编程接口201将产品识别码及/或序号输入至内窥镜的内部存储器104。授权软件200会初始化序号并标注设备未被使用过。图2中示出输入到内窥镜102的内部存储器的产品识别码及/或序号的示例格式,包含具有内部存储器104的内窥镜102,内部存储器104包含序号,产品识别码及先前激活数据。存储器104还可包括软件识别码及扫描器识别码。
标签101还可用于内窥镜102的抛弃式部件的识别码,例如抛弃式套管105,或者内窥镜102本身为抛弃式的内窥镜。标签101可为任何适当形式的标签,例如条形码、二维码、字母数字代码及/或标签101对应的射频识别(radio frequency identification,RFID)及近场通讯(near field communication,NFC)的信息。根据需求,标签101可以直接设置在内窥镜102及/或容器100上。在一些实施例中,设置在内窥镜102上的标签101可以包含与设置在容器100上的标签101不同的信息。
在对内窥镜102及/或容器100进行编程期间,可以使用序号及关于批号与制造相关联的其他信息来更新数据库204。在实施例中,内窥镜信息可以与软件应用程序及数据库的启用的区块链相关联。例如,一旦内窥镜102被正确启用,使用者可以得到特定服务,折扣或其他好处。
当授权软件200授权使用内窥镜102,就可启用内窥镜102并用于检查。内窥镜102通常连接到在特定医疗设施(医院,小型医疗诊所,救护车等)中的观察系统。观察系统可安装授权软件200,用于确保内窥镜对于特定医疗行为的适用性。
连接到内窥镜102的授权软件200还可选择性的包括云数据库300。云数据库300可设置于远端服务器上。云数据库300可以包括软件识别码301,产品识别码302,序号303及散列算法304。散列算法304可以应用前述任一项以增加安全性及加速数据库300的搜索。若内窥镜102预先设置产品识别码,则授权软件200将拒绝非序号格式的标签。序列号和产品识别码还可取决于固件版本。序号还可以包括启用期限。授权软件200还可基于某个有缺陷的部件或其他安全监管原因而不授权给一组有瑕疵的内窥镜。
观察系统还可以使用内窥镜102或容器100中包含的信息来确认要使用的内窥镜102为适合此项检查的内窥镜。例如,产品识别码可对应于内窥镜102的特定分辨率或总尺寸。当启动观察系统时,可输入此项检查的类型,若要执行的检查类型与产品识别码不一致时,则授权软件可拒绝启用内窥镜102。
在一定的时间间隔内,授权软件200会更新云数据库300的序号和产品识别码(于标签101或于内部存储器104内)。当与云数据库300连线时,授权软件200能向云数据库300查询相关信息。然而,在某些情况下,例如在救护车中,暂时无法连线至云数据库300时,可以使用本地数据库204来记录授权信息。当与云数据库300再次连线时,可用本地数据库204更新云数据库300的数据。
授权软件200还可包括用来扫描容器100或内窥镜102上标签101的扫描器400。扫描器400可以包括硬件通信应用程序编程接口401及/或软件通信应用程序编程接口402。扫描标签101可得到的验证信息来启用内窥镜102。在一实施例中,内窥镜102的摄像前端可被设置为扫描仪(例如,内窥镜用于扫描容器标签)。
在实施例中,当内窥镜102被启用,授权软件200可以更新内窥镜存储器104以反映启用信息并将信息传回云数据库300(预期用途,使用者代码,容器识别码等...)。这样即可以在仪器的使用周期内实现可追溯性。
内窥镜仪器还可包括传感器或无线通信设备检测及追踪内窥镜102的使用情形,当发现内窥镜102不适合于使用的医疗行为时,失能装置会以机械或电子方式禁止内窥镜102的使用以确保符合操作限制。例如,当授权软件200确认内窥镜102不符合使用条件时,授权软件200会启动失能装置来禁止使用内窥镜102。这种失能装置在美国专利申请号15/901,907的说明书中有详细说明。此装置可以单独使用或以组合在其他部件中使用。失能装置可阻止图像传感器发送信号,传输电流以熔化熔丝或关键部件,以机械或电子方式阻断套管105和手柄之间的连接使得套管105不能安装到手柄上,及/或使用射频识别(RFID),近场通讯(NFC)或射频天线的技术来检测套管以阻止套管105与内窥镜102内的机电接触,或电触发在套管105和手柄之间的磁铁,以关闭电子式或机械式连接。
图3为本发明内窥镜仪器的使用流程图500。
步骤510:授权软件200将产品识别码及/或序号输入内窥镜的内部存储器104及/或标签101;
步骤520:授权软件200通过硬件通信应用程序编程接口401及/或软件通信应用程序编程接口402之间的通信接收产品识别码及/或序号;
步骤530:授权软件200使用云通信应用程序编程接口202来找寻云数据库300中对应的产品识别码及/或序号。若可连线至云数据库300,则跳至步骤550,否则执行步骤540;
步骤540:若无法连线至云数据库300,则授权软件200会尝试使用本地数据库204来找寻对应的产品识别码及/或序号;
步骤550:授权软件200所接收的产品识别码及/或序号对应到内窥镜102是否为正确的内窥镜仪器?若是,执行步骤560,否则执行步骤570;
步骤560:授权软件200启用内窥镜102并更新对应的数据库;跳至步骤580;
步骤570:授权软件200开启失能装置以禁止使用内窥镜102。
步骤580:更新云数据库300中关于医疗行为,授权软件200及/或容器100的信息。
本发明提供的内窥镜仪器通过本文所述的技术可确保使用者丢弃无效的内窥镜,确保内窥镜的追溯性,并确保当内窥镜部件仅在符合其操作规范的方式才可使用。
以上所述仅为本发明的优选实施例而已,并不用于限制本发明,对于本领域的技术人员来说,本发明可以有各种更改和变化。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (19)
1.一种内窥镜仪器,其特征在于,包括:
内窥镜;
识别装置,用以识别所述内窥镜;
确认装置,用以根据所述识别装置识别的结果判断所述内窥镜是否适用于特定医疗行为;及
失能装置,用以当确定所述内窥镜不适用于所述特定医疗行为时,禁止使用所述内窥镜。
2.如权利要求1所述的内窥镜仪器,其特征在于,所述确认装置包括标签,固定于所述内窥镜上,所述标签具有产品识别码及/或序号。
3.如权利要求1所述的内窥镜仪器,其特征在于,还包括容器,用以容纳所述内窥镜,所述确认装置包括标签,固定于所述容器上,所述标签具有产品识别码及/或序号。
4.如权利要求1所述的内窥镜仪器,其特征在于,所述内窥镜包括内部非易失性存储器,所述识别装置包括所述内部非易失性存储器,所述内部非易失性存储器具有产品识别码及/或序号。
5.如权利要求4所述的内窥镜仪器,其特征在于,还包括容器,用以容纳所述内窥镜,所述识别装置还包括标签,固定于所述容器上,所述标签具有产品识别码及/或序号。
6.如权利要求2、3或5所述的内窥镜仪器,其特征在于,还包括扫描器,用以扫描所述标签,并将所述标签中所包括的产品识别码及/或序号输入到所述确认装置。
7.如权利要求1所述的内窥镜仪器,其特征在于,还包括授权装置,用以当确认所述内窥镜适用于所述特定医疗行为时,授权使用所述内窥镜。
8.如权利要求1所述的内窥镜仪器,其特征在于,还包括云数据库,所述云数据库包括关于软件、产品识别码及/或序号的信息,用以确认所述内窥镜或所述容器是否适用于所述特定医疗行为。
9.如权利要求8所述的内窥镜仪器,其特征在于,所述云数据库还包括应用于所述信息的散列算法,用以增加所述云数据库的安全性及搜寻速度。
10.如权利要求8所述的内窥镜仪器,其特征在于,还包括本地数据库,用以由产品识别码及/或序号来确认所述内窥镜是否适用于所述特定医疗行为,其中所述本地数据库为所述云数据库的备份。
11.如权利要求8所述的内窥镜仪器,其特征在于,所述云数据库的更新机制包括当确认所述内窥镜适合用于所述特定医疗行为时,更新所述云数据库关于所述内窥镜的启用、所述特定医疗行为、激活所述软件及/或所述容器的信息。
12.如权利要求1所述的内窥镜仪器,其特征在于,所述确认装置确认所述内窥镜是否适用于所述特定医疗行为的机制包括以下至少一条件:
所述内窥镜的元件是否先前已被使用且不应被重复使用;
所述元件是否已过期;
所述元件是否已被召回;
授权许可是否有效;
所述元件是否适用于所述特定医疗行为;及
固件版本是否有效。
13.如权利要求1所述的内窥镜仪器,其特征在于,所述失能装置藉由以下至少一机制禁止使用所述内窥镜:
阻止图像传感器发送信号;
传输电流以电熔化熔丝或关键部件;
以机械或电子方式阻断套管和手柄之间的连接,使得所述套管不能安装到所述手柄上;及
使用射频识别(radio frequency identification,RFID),近场通讯(nearfieldcommunication,NFC)或射频天线的技术来检测所述套管以阻断所述套管或所述内窥镜内的机电接触,及电触发在所述套管和所述手柄之间的磁铁,以关闭电子式或机械式的连接。
14.一种确保内窥镜的使用合乎规则的方法,其特征在于,包括:
给予所述内窥镜识别装置;
根据识别所述识别装置的结果判断所述内窥镜是否适用于特定医疗行为;及
当确定所述内窥镜不适用于所述特定医疗行为时,禁止使用所述内窥镜。
15.如权利要求14所述的方法,其特征在于,所述识别装置包括标签,固定于所述内窥镜或是所述内窥镜的容器上,所述标签具有产品识别码及/或序号。
16.如权利要求15所述的方法,其特征在于,还包括存取云数据库,所述云数据库包括关于软件、产品识别码及/或序号的信息,用以确认所述内窥镜或所述容器是否适用于所述特定医疗行为。
17.如权利要求16所述的方法,其特征在于,还包括当确认所述内窥镜适用于所述特定医疗行为时,更新所述云数据库关于所述内窥镜的启用、所述特定医疗行为、激活软件及/或所述容器的信息。
18.如权利要求16所述的方法,其特征在于,所述内窥镜及所述容器包含标签,所述方法还包括将所述容器标签与所述内窥镜标签匹配,以确保授权及/或完成内窥镜检查后将所述内窥镜返回到适当的容器中。
19.如权利要求16所述的方法,其特征在于,还包括利用所述识别装置在分发及/或返还内窥镜的每个阶段更新所述云数据库,以提供完整的可追溯性。
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