CN111566747A - 用于安全和认证趋势以及反应性措施的基于云的医疗分析 - Google Patents
用于安全和认证趋势以及反应性措施的基于云的医疗分析 Download PDFInfo
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Abstract
本发明公开了一种用于医疗数据网络的基于云的安全系统,所述基于云的安全系统包括:至少一个处理器;至少一个存储器,所述至少一个存储器通信地联接到所述处理器;输入/输出接口,所述输入/输出接口被配置用于访问来自多个医疗集线器的数据,所述多个医疗集线器各自通信地联接到至少一个外科器械;以及数据库,所述数据库驻留在所述至少一个存储器中并被配置为存储所述数据。所述至少一个处理器被编程为:识别由通信地联接到位于第一医疗设施处的第一医疗集线器的第一医疗器械引起的第一安全威胁;基于所述第一医疗器械和通信地联接到位于第二医疗设施处的第二医疗集线器的第二医疗器械之间的至少一个共同特性来确定在所述第二医疗集线器处存在第二安全威胁;以及向所述第二医疗设施提供关于所述第二安全威胁的警示。
Description
相关申请的交叉引用
本专利申请按照美国法典第35卷第119条(e)款的规定要求于2018年3月28日提交的名称为“CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDSAND REACTIVE MEASURES”的美国临时专利申请序列号62/649,327的优先权,该临时专利申请的公开内容全文以引用方式并入本文。
本专利申请按照美国法典第35卷第119条(e)款的规定还要求于2017年12月28日提交的名称为“INTERACTIVE SURGICAL PLATFORM”的美国临时专利申请序列号62/611,341、2017年12月28日提交的名称为“CLOUD-BASED MEDICAL ANALYTICS”的美国临时专利申请序列号62/611,340和2017年12月28日提交的名称为“ROBOT ASSISTED SURGICALPLATFORM”的美国临时专利申请序列号62/611,339的优先权,这些临时专利申请中的每个的公开内容全文以引用方式并入本文。
背景技术
本公开涉及各种外科系统。在数字和信息时代,由于患者安全和对保持传统实践的普遍期望,医疗系统和设施通常较慢地实现利用较新和改善的技术的系统或手术。然而,通常情况下,医疗系统和设施可能因此缺乏与其他相邻或类似位置的设施的通信和知识共享。为了改善患者实践,期望找到更好地帮助将医疗系统和设施互连的方法。
发明内容
在一个总体方面,提供了一种基于云的分析医疗系统。所述基于云的安全系统包括:至少一个处理器;至少一个存储器,所述至少一个存储器通信地联接到所述处理器;输入/输出接口,所述输入/输出接口被配置用于访问来自多个医疗集线器的数据,所述多个医疗集线器各自通信地联接到至少一个外科器械;以及数据库,所述数据库驻留在所述至少一个存储器中并被配置为存储所述数据。所述至少一个存储器存储指令,所述指令能够由所述至少一个处理器执行以:识别由通信地联接到位于第一医疗设施处的第一医疗集线器的第一医疗器械引起的第一安全威胁;基于所述第一医疗器械和通信地联接到位于第二医疗设施处的第二医疗集线器的第二医疗器械之间的至少一个共同特性来确定在所述第二医疗集线器处存在第二安全威胁;以及向所述第二医疗设施提供关于所述第二安全威胁的警示。
在另一个总体方面,医疗网络的另一个基于云的分析系统被配置为执行一种方法。所述基于云的分析系统改善了医疗环境中的安全和认证。医疗数据网络还包括至少一个外科器械和各自通信地联接到所述基于云的安全系统的多个医疗集线器。所述方法包括:由所述基于云的安全系统识别由通信地联接到位于第一医疗设施处的第一医疗集线器的第一医疗器械引起的第一安全威胁;由所述基于云的安全系统基于所述第一医疗器械和通信地联接到位于第二医疗设施处的第二医疗集线器的第二医疗器械之间的至少一个共同特性来确定在所述第二医疗集线器处存在第二安全威胁;以及由所述基于云的安全系统向所述第二医疗设施提供关于所述第二安全威胁的警示。
在又一个总体方面,提供了一种计算机可读介质。所述计算机可读介质是非暂态的并且包括指令,所述指令在由医疗数据网络的基于云的安全系统的处理器执行时,使所述处理器执行包括以下各项的操作:识别由通信地联接到位于第一医疗设施处的第一医疗集线器的第一医疗器械引起的第一安全威胁;基于所述第一医疗器械和通信地联接到位于第二医疗设施处的第二医疗集线器的第二医疗器械之间的至少一个共同特性来确定在所述第二医疗集线器处存在第二安全威胁;以及向所述第二医疗设施提供关于所述第二安全威胁的警示。
附图说明
各种方面的特征在所附权利要求书中进行了特别描述。然而,通过参考以下结合如下附图所作的说明可最好地理解所述多个方面(有关手术组织和方法)及其进一步的目的和优点。
图1为根据本公开的至少一个方面的计算机实现的交互式外科系统的框图。
图2为根据本公开的至少一个方面的用于在手术室中执行外科手术的外科系统。
图3为根据本公开的至少一个方面的与可视化系统、机器人系统和智能器械配对的外科集线器。
图4为根据本公开的至少一个方面的外科集线器壳体和可滑动地容纳在外科集线器壳体的抽屉中的组合发生器模块的局部透视图。
图5为根据本公开的至少一个方面的具有双极、超声和单极接触件以及排烟器件的组合发生器模块的透视图。
图6示出了根据本公开的至少一个方面的用于横向模块化外壳的多个横向对接端口的单个电力总线附接件,该横向模块化外壳被配置为容纳多个模块。
图7示出了根据本公开的至少一个方面的被配置为容纳多个模块的竖直模块化外壳。
图8示出了根据本公开的至少一个方面的包括模块化通信集线器的外科数据网络,该模块化通信集线器被配置为将位于医疗设施的一个或多个手术室中的模块化装置或专用于外科手术的医疗设施中的任何房间连接到云。
图9为根据本公开的至少一个方面的计算机实现的交互式外科系统。
图10示出了根据本公开的至少一个方面的包括联接到模块化控制塔的多个模块的外科集线器。
图11示出了根据本公开的至少一个方面的通用串行总线(USB)网络集线器装置的一个方面。
图12示出了根据本公开的至少一个方面的外科器械或工具的控制系统的逻辑图。
图13示出了根据本公开的至少一个方面的被配置为控制外科器械或工具的各个方面的控制电路。
图14示出了根据本公开的至少一个方面的被配置为控制外科器械或工具的各个方面的组合逻辑电路。
图15示出了根据本公开的至少一个方面的被配置为控制外科器械或工具的各方面的时序逻辑电路。
图16示出了根据本公开的至少一个方面的包括多个马达的外科器械或工具,多个马达可被激活以执行各种功能。
图17为根据本公开的至少一个方面的被配置为操作本文所述的外科工具的机器人外科器械的示意图。
图18示出了根据本公开的至少一个方面的被编程以控制位移构件的远侧平移的外科器械的框图。
图19为根据本公开的至少一个方面的被配置为控制各个功能的外科器械的示意图。
图20为根据本公开的至少一个方面的被配置为除了其他有益效果之外还提供无电感器调谐的发生器的简化框图。
图21示出根据本公开的至少一个方面的为图20的发生器的一种形式的发生器的示例。
图22为根据本公开的至少一个方面的计算机实现的交互式外科系统的框图。
图23为根据本公开的至少一个方面的示出计算机实现的交互式外科系统的功能架构的框图。
图24提供了根据本公开的至少一个方面的云医疗分析系统的示例性功能的图示,该云医疗分析系统用于向互连的多个医疗设施提供改善的安全和认证。
图25为根据本公开的至少一个方面的描绘外科集线器的态势感知的时间轴。
具体实施方式
本申请的申请人拥有于2018年3月28日提交的以下美国临时专利申请,这些临时专利申请中的每个全文以引用方式并入本文:
·名称为“INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATIONCAPABILITIES”的美国临时专利申请序列号62/649,302;
·名称为“DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS ANDCREATE ANONYMIZED RECORD”的美国临时专利申请序列号62/649,294;
·名称为“SURGICAL HUB SITUATIONAL AWARENESS”的美国专利申请序列号62/649,300;
·名称为“SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES INOPERATING THEATER”的美国临时专利申请序列号62/649,309;
·名称为“COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS”的美国临时专利申请序列号62/649,310;
·名称为“USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TODETERMINE PROPERTIES OF BACK SCATTERED LIGHT”的美国临时专利申请序列号62/649,291;
·名称为“ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES”的美国临时专利申请序列号62/649,296;
·名称为“CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION ANDRECOMMENDATIONS TO A USER”的美国临时专利申请序列号62/649,333;
·名称为“CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY ANDAUTHENTICATION TRENDS AND REACTIVE MEASURES”的美国临时专利申请序列号62/649,327;
·名称为“DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICSNETWORK”的美国临时专利申请序列号62/649,315;
·名称为“CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES”的美国临时专利申请序列号62/649,313;
·名称为“DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”的美国临时专利申请序列号62/649,320;
·名称为“AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS”的美国临时专利申请序列号62/649,307;以及
·名称为“SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”的美国临时专利申请序列号62/649,323。
本专利申请的申请人拥有于2018年3月29日提交的以下美国专利申请,这些专利申请中的每个全文以引用方式并入本文:
·名称为“INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATIONCAPABILITIES”的美国专利申请序列号______;代理人案卷号END8499USNP/170766;
·名称为“INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OFDEVICES AND DATA CAPABILITIES”的美国专利申请序列号______;代理人案卷号END8499USNP1/170766-1;
·名称为“SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OFOPERATING ROOM DEVICES”的美国专利申请序列号______;代理人案卷号END8499USNP2/170766-2;
·名称为“SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS”的美国专利申请序列号______;代理人案卷号END8499USNP3/170766-3;
·名称为“COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARYSOURCES BY INTELLIGENT SURGICAL HUBS”的美国专利申请序列号______;代理人案卷号END8499USNP4/170766-4;
·名称为“SURGICAL HUB CONTROL ARRANGEMENTS”的美国专利申请序列号______;代理人案卷号END8499USNP5/170766-5;
·名称为“DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS ANDCREATE ANONYMIZED RECORD”的美国专利申请序列号______;代理人案卷号END8500USNP/170767;
·名称为“COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERSAND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICSSYSTEMS”的美国专利申请序列号______;代理人案卷号END8500USNP1/170767-1;
·名称为“SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUINGINSTRUMENT”的美国专利申请序列号______;代理人案卷号END8500USNP2/170767-2;
·名称为“DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETERWITH AN OUTCOME”的美国专利申请序列号______;代理人案卷号END8500USNP3/170767-3;
·名称为“SURGICAL HUB SITUATIONAL AWARENESS”的美国专利申请序列号______;代理人案卷号END8501USNP/170768;
·名称为“SURGICAL SYSTEM DISTRIBUTED PROCESSING”的美国专利申请序列号______;代理人案卷号END8501USNP1/170768-1;
·名称为“AGGREGATION AND REPORTING OF SURGICAL HUB DATA”的美国专利申请序列号______;代理人案卷号END8501USNP2/170768-2;
·名称为“SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES INOPERATING THEATER”的美国专利申请序列号______;代理人案卷号END8502USNP/170769;
·名称为“DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEARSTAPLE LINE”的美国专利申请序列号______;代理人案卷号END8502USNP1/170769-1;
·名称为“STERILE FIELD INTERACTIVE CONTROL DISPLAYS”的美国专利申请序列号______;代理人案卷号END8502USNP2/170769-2;
·名称为“COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS”的美国专利申请序列号______;代理人案卷号END8503USNP/170770;
·名称为“USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TODETERMINE PROPERTIES OF BACK SCATTERED LIGHT”的美国专利申请序列号______;代理人案卷号END8504USNP/170771;
·名称为“CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OFMONO-CHROMATIC LIGHT REFRACTIVITY”的美国专利申请序列号;代理人案卷号END8504USNP1/170771-1;以及
·名称为“DUAL CMOS ARRAY IMAGING”的美国专利申请序列号______;代理人案卷号END8504USNP2/170771-2。
本专利申请的申请人拥有于2018年3月29日提交的以下美国专利申请,这些专利申请中的每个全文以引用方式并入本文:
·名称为“ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES”的美国专利申请序列号______;代理人案卷号END8506USNP/170773;
·名称为“ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS”的美国专利申请序列号______;代理人案卷号END8506USNP1/170773-1;
·名称为“CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION ANDRECOMMENDATIONS TO A USER”的美国专利申请序列号______;代理人案卷号END8507USNP/170774;
·名称为“CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGETRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET”的美国专利申请序列号______;代理人案卷号END8507USNP1/170774-1;
·名称为“CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTEDINDIVIDUALIZATION OF INSTRUMENT FUNCTION”的美国专利申请序列号______;代理人案卷号END8507USNP2/170774-2;
·名称为“DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICSNETWORK”的美国专利申请序列号______;代理人案卷号END8509USNP/170776;以及
·名称为“CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES”的美国专利申请序列号______;代理人案卷号END8510USNP/170777。
本专利申请的申请人拥有于2018年3月29日提交的以下美国专利申请,这些专利申请中的每个全文以引用方式并入本文:
·名称为“DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”的美国专利申请序列号______;代理人案卷号END8511USNP/170778;
·名称为“COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS”的美国专利申请序列号______;代理人案卷号END8511USNP1/170778-1;
·名称为“CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”的美国专利申请序列号______;代理人案卷号END8511USNP2/170778-2;
·名称为“AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS”的美国专利申请序列号______;代理人案卷号END8512USNP/170779;
·名称为“CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”的美国专利申请序列号;代理人案卷号END8512USNP1/170779-1;
·名称为“COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICALPLATFORMS”的美国专利申请序列号;代理人案卷号END8512USNP2/170779-2;
·名称为“DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”的美国专利申请序列号______;代理人案卷号END8512USNP3/170779-3;以及
·名称为“SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”的美国专利申请序列号______;代理人案卷号END8513USNP/170780。
在详细说明外科装置和发生器的各个方面之前,应该指出的是,示例性示例的应用或使用并不局限于附图和具体实施方式中所示出的部件的配置和布置方式的细节。示例性示例可以单独实施,或与其它方面、变更形式和修改形式结合在一起实施,并可以通过多种方式实践或执行。此外,除非另外指明,否则本文所用的术语和表达是为了方便读者而对示例性实施例进行描述而所选的,并非为了限制性的目的。而且,应当理解,以下描述的方面中的一个或多个、方面和/或示例的表达可以与以下描述的其他方面、方面和/或示例的表达中的任何一个或多个组合。
参见图1,计算机实现的交互式外科系统100包括一个或多个外科系统102和基于云的系统(例如,可包括联接到存储装置105的远程服务器113的云104)。每个外科系统102包括与可包括远程服务器113的云104通信的至少一个外科集线器106。在一个示例中,如图1中所示,外科系统102包括可视化系统108、机器人系统110和手持式智能外科器械112,其被配置为彼此通信并且/或者与集线器106通信。在一些方面,外科系统102可包括M数量的集线器106、N数量的可视化系统108、O数量的机器人系统110和P数量的手持式智能外科器械112,其中M、N、O和P为大于或等于一的整数。
图3示出了用于对平躺在外科手术室116中的手术台114上的患者执行外科手术的外科系统102的示例。机器人系统110在外科手术中用作外科系统102的一部分。机器人系统110包括外科医生的控制台118、患者侧推车120(外科机器人)和外科机器人集线器122。当外科医生通过外科医生的控制台120观察外科部位时,患者侧推车117可通过患者体内的微创切口操纵至少一个可移除地联接的外科工具118。外科部位的图像可通过医疗成像装置124获得,该医疗成像装置可由患者侧推车120操纵以定向成像装置124。机器人集线器122可用于处理外科部位的图像,以随后通过外科医生的控制台118显示给外科医生。
其他类型的机器人系统可容易地适于与外科系统102一起使用。适用于本公开的机器人系统和外科工具的各种示例在2017年12月28日提交的名称为“ROBOT ASSISTEDSURGICAL PLATFORM”的美国临时专利申请序列号62/611,339中有所描述,该专利的公开内容全文以引用方式并入本文。
由云104执行并且适用于本公开的基于云的分析的各种示例描述于2017年12月28日提交的名称为“CLOUD-BASED MEDICAL ANALYTICS”的美国临时专利申请序列号62/611,340中,其公开内容全文以引用方式并入本文。
在各种方面,成像装置124包括至少一个图像传感器和一个或多个光学部件。合适的图像传感器包括但不限于电荷耦合器件(CCD)传感器和互补金属氧化物半导体(CMOS)传感器。
成像装置124的光学器件可包括一个或多个照明源和/或一个或多个透镜。一个或多个照明源可被引导以照明外科场地的多部分。一个或多个图像传感器可接收从外科场地反射或折射的光,包括从组织和/或外科器械反射或折射的光。
一个或多个照明源可被配置为辐射可见光谱中的电磁能以及不可见光谱。可见光谱(有时被称为光学光谱或发光光谱)是电磁光谱中对人眼可见(即,可被其检测)的那部分,并且可被称为可见光或简单光。典型的人眼将对空气中约380nm至约750nm的波长作出响应。
不可见光谱(即,非发光光谱)是电磁光谱的位于可见光谱之下和之上的部分(即,低于约380nm且高于约750nm的波长)。人眼不可检测不可见光谱。大于约750nm的波长长于红色可见光谱,并且它们变为不可见的红外(IR)、微波和无线电电磁辐射。小于约380nm的波长比紫色光谱短,并且它们变为不可见的紫外、x射线和γ射线电磁辐射。
在各种方面,成像装置124被配置为用于微创手术中。适用于本公开的成像装置的示例包括但不限于关节镜、血管镜、支气管镜、胆道镜、结肠镜、细胞检查镜、十二指镜、肠窥镜、食道-十二指肠镜(胃镜)、内窥镜、喉镜、鼻咽-肾内窥镜、乙状结肠镜、胸腔镜和子宫内窥镜。
在一个方面,成像装置采用多光谱监测来辨别形貌和底层结构。多光谱图像是捕获跨电磁波谱的特定波长范围内的图像数据的图像。可通过滤波器或通过使用对特定波长敏感的器械来分离波长,特定波长包括来自可见光范围之外的频率的光,例如IR和紫外。光谱成像可允许提取人眼未能用其红色,绿色和蓝色的受体捕获的附加信息。多光谱成像的使用在2017年12月28日提交的名称为“INTERACTIVE SURGICAL PLATFORM”的美国临时专利申请序列号62/611,341的标题“Advanced Imaging Acquisition Module”下更详细地描述,该专利的公开内容全文以引用方式并入本文。在完成外科任务以对处理过的组织执行一个或多个先前所述测试之后,多光谱监测可以是用于重新定位外科场地的有用工具。不言自明的是,在任何外科期间都需要对手术室和外科设备进行严格消毒。在“外科室”(即,手术室或治疗室)中所需的严格的卫生和消毒条件需要所有医疗装置和设备的最高可能的无菌性。该灭菌过程的一部分是需要对接触患者或穿透无菌场的任何物质进行灭菌,包括成像装置124及其附接件和器件。应当理解,无菌场可被认为是被认为不含微生物的指定区域,诸如在托盘内或无菌毛巾内,或者无菌场可被认为是已准备用于外科手术的患者周围的区域。无菌场可包括被恰当地穿着的擦洗的团队构件,以及该区域中的所有家具和固定件。
在各种方面,可视化系统108包括一个或多个成像传感器、一个或多个图像处理单元、一个或多个存储阵列、以及一个或多个显示器,该一个或多个显示器相对于无菌场进行策略布置,如图2中所示。在一个方面,可视化系统108包括用于HL7、PACS和EMR的界面。可视化系统108的各种部件在2017年12月28日提交的名称为“INTERACTIVE SURGICALPLATFORM”的美国临时专利申请序列号62/611,341的标题“Advanced ImagingAcquisition Module”下有所描述,该专利申请的公开内容全文以引用方式并入本文。
如图2中所示,主显示器119被定位在无菌场中,以对在手术台114处的操作者可见。此外,可视化塔111被定位在无菌场之外。可视化塔111包括彼此背离的第一非无菌显示器107和第二非无菌显示器109。由集线器106引导的可视化系统108被配置为利用显示器107、109和119来将信息流协调到无菌场内侧和外侧的操作者。例如,集线器106可使可视化系统108在非无菌显示器107或109上显示由成像装置124记录的外科部位的快照,同时保持外科部位在主显示器119上的实时馈送。例如,非无菌显示器107或109上的快照可允许非无菌操作者执行与外科手术相关的诊断步骤。
在一个方面,集线器106还被配置为将由非无菌操作者在可视化塔111处输入的诊断输入或反馈传送到无菌场内的主显示器119,其中可由操作台上的无菌操作员查看。在一个示例中,输入可以是对显示在非无菌显示器107或109上的快照的修改形式,其可通过集线器106传送到主显示器119。
参见图2,外科器械112作为外科系统102的一部分在外科手术中使用。集线器106还被配置为协调流向外科器械112的显示器的信息流。例如,在2017年12月28日提交的名称为“INTERACTIVE SURGICAL PLATFORM”的美国临时专利申请序列号62/611,341,其公开内容全文以引用方式并入本文。由非无菌操作者在可视化塔111处输入的诊断输入或反馈可由集线器106传送到无菌场内的外科器械显示器115,其中外科器械112的操作者可观察到该输入或反馈。适用于外科系统102的示例性外科器械在2017年12月28日提交的名称为“INTERACTIVE SURGICAL PLATFORM”的美国临时专利申请序列号62/611,341的标题“Surgical Instrument Hardware”下有所描述,该临时专利申请的公开内容全文以引用方式并入本文。
现在参见图3,集线器106被描绘为与可视化系统108、机器人系统110和手持式智能外科器械112通信。集线器106包括集线器显示器135、成像模块138、发生器模块140、通信模块130、处理器模块132和存储阵列134。在某些方面,如图3中所示,集线器106还包括排烟模块126和/或抽吸/冲洗模块128。
在外科手术期间,用于密封和/或切割的对组织的能量施加通常与排烟、抽吸过量流体和/或冲洗组织相关。来自不同来源的流体管线、功率管线和/或数据管线通常在外科手术期间缠结。在外科手术期间解决该问题可丢失有价值的时间。断开管线可需要将管线与其相应的模块断开连接,这可需要重置模块。集线器模块化壳体136提供用于管理功率管线、数据管线和流体管线的统一环境,这降低了此类管线之间缠结的频率。
本公开的各方面提供了用于外科手术的外科集线器,该外科手术涉及将能量施加到外科部位处的组织。外科集线器包括集线器壳体和可滑动地容纳在集线器壳体的对接底座中的组合发生器模块。对接底座包括数据和功率接触件。组合发生器模块包括座置在单个单元中的超声能量发生器器件、双极RF能量发生器器件和单极RF能量发生器器件中的两个或更多个。在一个方面,组合发生器模块还包括排烟器件,用于将组合发生器模块连接到外科器械的至少一根能量递送缆线、被配置为排出通过向组织施加治疗能量而产生的烟雾、流体和/或颗粒的至少一个排烟器件、以及从远程外科部位延伸至排烟器件的流体管线。
在一个方面,流体管线是第一流体管线,并且第二流体管线从远程外科部位延伸至可滑动地容纳在集线器壳体中的抽吸和冲洗模块。在一个方面,集线器壳体包括流体接口。
某些外科手术可需要将多于一种能量类型施加到组织。一种能量类型可更有利于切割组织,而另一种不同的能量类型可更有利于密封组织。例如,双极发生器可用于密封组织,而超声发生器可用于切割密封的组织。本公开的各方面提供了一种解决方案,其中集线器模块化壳体136被配置为容纳不同的发生器,并且有利于它们之间的交互式通信。集线器模块化壳体136的优点之一是能够快速地移除和/或更换各种模块。
本公开的方面提供了在涉及将能量施加到组织的外科手术中使用的模块化外科壳体。模块化外科壳体包括:第一能量发生器模块,该第一能量发生器模块被配置为生成用于施加到组织的第一能量;和第一对接底座,该第一对接底座包括第一对接端口,该第一对接端口包括第一数据和功率接触件,其中第一能量发生器模块可滑动地移动成与该功率和数据接触件电接合,并且其中第一能量发生器模块可滑动地移动成不与第一功率和数据接触件电接合。
对上文进行进一步描述,模块化外科壳体还包括:第二能量发生器模块,该第二能量发生器模块被配置为生成不同于第一能量的第二能量以用于施加到组织;和第二对接底座,该第二对接底座包括第二对接端口,该第二对接端口包括第二数据和功率接触件,其中第二能量发生器模块可滑动地移动成与功率和数据接触件电接合,并且其中第二能量发生器模块可滑动地移动成不与第二功率和数据接触件电接合。
此外,模块化外科壳体还包括在第一对接端口和第二对接端口之间的通信总线,其被配置为有利于第一能量发生器模块和第二能量发生器模块之间的通信。
参见图3-7,本公开的各方面被呈现为集线器模块化壳体136,其允许发生器模块140、排烟模块126和抽吸/冲洗模块128的模块化集成。集线器模块化壳体136还有利于模块140、126、128之间的交互式通信。如图5中所示,发生器模块140可为具有集成的单极器件、双极器件和超声器件的发生器模块,该器件被支撑在可滑动地插入到集线器模块化壳体136中的单个外壳单元139中。如图5中所示,发生器模块140可被配置为连接到单极装置146、双极装置147和超声装置148。另选地,发生器模块140可包括通过集线器模块化壳体136进行交互的一系列单极发生器模块、双极发生器模块和/或超声发生器模块。集线器模块化壳体136可被配置为有利于多个发生器的插入和对接到集线器模块化壳体136中的发生器之间的交互通信,使得这些发生器将充当单个发生器。
在一个方面,集线器模块化壳体136包括具有外部和无线通信接头的模块化功率和通信底板149,以实现模块140、126、128的可移除附接件以及它们之间的交互通信。
在一个方面,集线器模块化壳体136包括对接底座或抽屉151(本文也称为抽屉),其被配置为可滑动地容纳模块140、126、128。图4示出了可滑动地容纳在外科集线器壳体136的对接底座151中的外科集线器壳体136和组合发生器模块145的局部透视图。在组合发生器模块145的背面上具有功率和数据接触件的对接端口152被配置为当组合发生器模块145滑动到集线器模块壳体136的对应的对接底座151内的适当位置时,将对应的对接端口150与集线器模块化壳体136的对应的对接底座151的功率和数据接触件接合。在一个方面,组合发生器模块145包括一起集成到单个外壳单元139中的双极、超声和单极模块以及排烟模块,如图5中所示。
在各种方面,排烟模块126包括流体管线154,该流体管线154将捕集/收集的烟雾和/或流体从外科部位传送到例如排烟模块126。源自排烟模块126的真空抽吸可将烟雾吸入外科部位处的公用导管的开口中。联接到流体管线的实用导管可以是端接在排烟模块126处的柔性管的形式。公用导管和流体管线限定朝向容纳在集线器壳体136中的排烟模块126延伸的流体路径。
在各种方面,抽吸/冲洗模块128联接到包括吸出流体管线和抽吸流体管线的外科工具。在一个示例中,吸出流体管线和抽吸流体管线为从外科部位朝向抽吸/冲洗模块128延伸的柔性管的形式。一个或多个驱动系统可被配置为冲洗到外科部位的流体和从外科部位抽吸流体。
在一个方面,外科工具包括轴,该轴具有在其远侧端部处的端部执行器以及与端部执行器、吸出管和冲洗管相关联的至少一种能量处理。吸出管可在其远侧端部处具有入口,并且吸出管延伸穿过轴。类似地,吸出管可延伸穿过轴并且可具有邻近能量递送工具的入口。能量递送工具被配置为将超声能量和/或RF能量递送至外科部位,并且通过初始延伸穿过轴的缆线联接到发生器模块140。
冲洗管可与流体源流体连通,并且吸出管可与真空源流体连通。流体源和/或真空源可座置在抽吸/冲洗模块128中。在一个示例中,流体源和/或真空源可独立于抽吸/冲洗模块128容纳在集线器壳体136中。在此类示例中,流体接口能够将抽吸/冲洗模块128连接到流体源和/或真空源。
在一个方面,集线器模块化壳体136上的模块140、126、128和/或其对应的对接底座可包括对准特征件,该对准特征件被配置为将模块的对接端口对准成与其在集线器模块化壳体136的对接底座中的对应端口接合。例如,如图4中所示,组合发生器模块145包括侧支架155,该侧支架155被配置为与集线器模块化壳体136的对应的对接底座151的对应托架156可滑动地接合。该支架配合以引导组合发生器模块145的对接端口接触件与集线器模块化壳体136的对接端口接触件电接合。
在一些方面,集线器模块化壳体136的抽屉151为相同的或大体上相同的大小,并且模块的大小被调节为容纳在抽屉151中。例如,侧支架155和/或156可根据模块的大小而更大或更小。在其它方面,抽屉151的大小不同,并且各自被设计成容纳特定模块。
此外,可对特定模块的接触件进行键控以与特定抽屉的接触件接合,以避免将模块插入到具有不匹配接触件的抽屉中。
如图4中所示,一个抽屉151的对接端口150可通过通信链路157联接到另一个抽屉151的对接端口150,以有利于座置在集线器模块化壳体136中的模块之间的交互式通信。另选地或附加地,集线器模块化壳体136的对接端口150可有利于容纳在集线器模块化壳体136中的模块之间的无线交互通信。可采用任何合适的无线通信,诸如例如Air Titan-Bluetooth。
图6示出了用于横向模块化外壳160的多个横向对接端口的单个功率总线附接件,该横向模块化外壳160被配置为容纳外科集线器206的多个模块。横向模块化外壳160被配置为横向容纳和互连模块161。模块161可滑动地插入到横向模块化外壳160的对接底座162中,该横向模块化外壳160包括用于互连模块161的底板。如图6中所示,模块161横向布置在横向模块化外壳160中。另选地,模块161可竖直地布置在横向模块化外壳中。
图7示出了被配置为容纳外科集线器106的多个模块165的竖直模块化外壳164。模块165可滑动地插入到竖直模块化外壳164的对接底座或抽屉167中,该竖直模块化外壳164包括用于互连模块165的底板。尽管竖直模块化外壳164的抽屉167竖直布置,但在某些情况下,竖直模块化外壳164可包括横向布置的抽屉。此外,模块165可通过竖直模块化外壳164的对接端口彼此交互。
在图7的示例中,提供了用于显示与模块165的操作相关的数据的显示器177。此外,竖直模块化外壳164包括主模块178,该主模块座置可滑动地容纳在主模块178中的多个子模块。
在各种方面,成像模块138包括集成视频处理器和模块化光源,并且适于与各种成像装置一起使用。在一个方面,成像装置由可装配有光源模块和相机模块的模块化外壳构成。外壳可为一次性外壳。在至少一个示例中,一次性外壳可移除地联接到可重复使用的控制器、光源模块和相机模块。光源模块和/或相机模块可根据外科手术的类型选择性地选择。在一个方面,相机模块包括CCD传感器。在另一方面,相机模块包括CMOS传感器。在另一方面,相机模块被配置用于扫描波束成像。同样,光源模块可被配置为递送白光或不同的光,这取决于外科手术。
在外科手术期间,从外科场地移除外科装置并用包括不同相机或不同光源的另一外科装置替换外科装置可为低效的。暂时失去对外科场地的视线可导致不期望的后果。本公开的模块成像装置被配置为允许在外科手术期间中流替换光源模块或相机模块,而不必从外科场地移除成像装置。
在一个方面,成像装置包括包括多个通道的管状外壳。第一通道被配置为可滑动地容纳相机模块,该相机模块可被配置为与第一通道搭扣配合接合。第二通道被配置为可滑动地容纳光源模块,该光源模块可被配置为与第二通道搭扣配合接合。在另一个示例中,相机模块和/或光源模块可在其相应通道内旋转到最终位置。可采用螺纹接合代替搭扣配合接合。
在各种示例中,多个成像装置被放置在外科场地中的不同位置以提供多个视图。成像模块138可被配置为在成像装置之间切换以提供最佳视图。在各种方面,成像模块138可被配置为集成来自不同成像装置的图像。
适用于本公开的各种图像处理器和成像装置描述于2011年8月9日公布的名称为“COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR”的美国专利No.7,995,045中,该专利全文以引用方式并入本文。此外,2011年7月19日公布的名称为“SBI MOTION ARTIFACTREMOVAL APPARATUS AND METHOD”的美国专利No.7,982,776描述了用于从图像数据中去除运动伪影的各种系统,该专利全文以引用方式并入本文。此类系统可与成像模块138集成。此外,2011年12月15日公布的名称为“CONTROLLABLE MAGNETIC SOURCE TO FIXTUREINTRACORPOREAL APPARATUS”的美国专利申请公布2011/0306840和2014年8月28日公布的名称为“SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE”的美国专利申请公布2014/0243597,以上专利中的每个全文以引用方式并入本文。
图8示出了包括模块化通信集线器203的外科数据网络201,该模块化通信集线器203被配置为将位于医疗设施的一个或多个手术室中的模块化装置或专门配备用于外科操作的医疗设施中的任何房间连接到基于云的系统(例如,可包括联接到存储装置205的远程服务器213的云204)。在一个方面,模块化通信集线器203包括与网络路由器通信的网络集线器207和/或网络交换机209。模块化通信集线器203还可联接到本地计算机系统210以提供本地计算机处理和数据操纵。外科数据网络201可被配置为无源的、智能的或交换的。无源外科数据网络充当数据的管道,从而使其能够从一个装置(或区段)转移到另一个装置(或区段)以及云计算资源。智能外科数据网络包括附加特征,以使得能够监测穿过外科数据网络的流量并配置网络集线器207或网络交换器209中的每个端口。智能外科数据网络可被称为可管理的集线器或交换器。交换集线器读取每个包的目标地址,并且然后将包转发到正确的端口。
位于手术室中的模块化装置1a-1n可联接到模块化通信集线器203。网络集线器207和/或网络交换机209可联接到网络路由器211,以将装置1a-1n连接至云204或本地计算机系统210。与装置1a-1n相关联的数据可经由路由器传输到基于云的计算机,用于远程数据处理和操纵。与装置1a-1n相关联的数据也可被传输至本地计算机系统210以用于本地数据处理和操纵。位于相同手术室中的模块化装置2a-2m也可联接到网络交换机209。网络交换机209可联接到网络集线器207和/或网络路由器211以将装置2a-2m连接至云204。与装置2a-2n相关联的数据可经由网络路由器211传输到云204以用于数据处理和操纵。与装置2a-2m相关联的数据也可被传输至本地计算机系统210以用于本地数据处理和操纵。
应当理解,可通过将多个网络集线器207和/或多个网络交换机209与多个网络路由器211互连来扩展外科数据网络201。模块化通信集线器203可被包含在模块化控制塔中,该模块化控制塔被配置为容纳多个装置1a-1n/2a-2m。本地计算机系统210也可包含在模块化控制塔中。模块化通信集线器203连接到显示器212以显示例如在外科手术期间由装置1a-1n/2a-2m中的一些获得的图像。在各种方面,装置1a-1n/2a-2m可包括例如各种模块,诸如联接到内窥镜的成像模块138、联接到基于能量的外科装置的发生器模块140、排烟模块126、抽吸/冲洗模块128、通信模块130、处理器模块132、存储阵列134、联接到显示器的外科装置、和/或可连接到外科数据网络201的模块化通信集线器203的其他模块化装置中的非接触传感器模块。
在一个方面,外科数据网络201可包括将装置1a-1n/2a-2m连接至云的(一个或多个)网络集线器、(一个或多个)网络交换机和(一个或多个)网络路由器的组合。联接到网络集线器或网络交换机的装置1a-1n/2a-2m中的任何一个或全部装置可实时收集数据并将数据传输到云计算机中以进行数据处理和操纵。应当理解,云计算依赖于共享计算资源,而不是使用本地服务器或个人装置来处理软件应用程序。可使用“云”一词作为“互联网”的隐喻,尽管该术语不受此限制。因此,本文可使用术语“云计算”来指“基于互联网的计算的类型”,其中将不同的服务(诸如服务器、存储器和应用程序)递送至位于外科手术室(例如,固定、移动、临时或现场手术室或空间)中的模块化通信集线器203和/或计算机系统210以及通过互联网连接至模块化通信集线器203和/或计算机系统210的装置。云基础设施可由云服务提供方维护。在这种情况下,云服务提供方可以是协调位于一个或多个手术室中的装置1a-1n/2a-2m的使用和控制的实体。云计算服务可基于由智能外科器械、机器人和位于手术室中的其它计算机化装置所收集的数据来执行大量计算。集线器硬件使多个装置或连接能够连接到与云计算资源和存储器通信的计算机。
对由装置1a-1n/2a-2m所收集的数据应用云计算机数据处理技术,外科数据网络提供改善的外科结果,降低的成本和改善的患者满意度。可采用装置1a-1n/2a-2m中的至少一些来观察组织状态以评估在组织密封和切割手术之后密封的组织的渗漏或灌注。可采用装置1a-1n/2a-2m中的至少一些来识别病理学,诸如疾病的影响,使用基于云的计算检查包括用于诊断目的的身体组织样本的图像的数据。这包括组织和表型的定位和边缘确认。可采用装置1a-1n/2a-2m中的至少一些使用与成像装置和技术(诸如叠加由多个成像装置捕集的图像)集成的各种传感器来识别身体的解剖结构。由装置1a-1n/2a-2m收集的数据(包括图像数据)可被传输到云204或本地计算机系统210或两者以用于数据处理和操纵,包括图像处理和操纵。可分析数据以通过确定是否可继续进行进一步治疗(诸如内窥镜式干预、新兴技术、靶向辐射、靶向干预和精确机器人对组织特异性位点和条件的应用来改善外科手术结果。此类数据分析可进一步采用结果分析处理,并且使用标准化方法可提供有益反馈以确认外科治疗和外科医生的行为,或建议修改外科治疗和外科医生的行为。
在一个具体实施中,手术室装置1a-1n可通过有线信道或无线信道连接至模块化通信集线器203,这取决于装置1a-1n至网络集线器的配置。在一个方面,网络集线器207可被实现为在开放式系统互连(OSI)模型的物理层上工作的本地网络广播装置。该网络集线器提供与位于同一手术室网络中的装置1a-1n的连接。网络集线器207以包(packet)的形式收集数据,并以半双工模式将其发送至路由器。网络集线器207不存储任何媒体访问控制/因特网协议(MAC/IP)以传输该装置数据。装置1a-1n中的仅一个可一次通过网络集线器207发送数据。网络集线器207没有关于在何处发送信息并在每个连接上广播所有网络数据以及通过云204向远程服务器213(图9)广播所有网络数据的路由表或智能。网络集线器207可以检测基本网络错误诸如冲突,但将所有信息广播到多个端口可带来安全风险并导致瓶颈。
在另一个具体实施中,手术室装置2a-2m可通过有线信道或无线信道连接到网络交换机209。网络交换机209在OSI模型的数据链路层中工作。网络交换机209是用于将位于相同手术室中的装置2a-2m连接到网络的多点广播装置。网络交换机209以帧的形式向网络路由器211发送数据并且以全双工模式工作。多个装置2a-2m可通过网络交换机209同时发送数据。网络交换机209存储并使用装置2a-2m的MAC地址来传输数据。
网络集线器207和/或网络交换机209联接到网络路由器211以连接到云204。网络路由器211在OSI模型的网络层中工作。网络路由器211创建用于将从网络集线器207和/或网络交换机211接收的数据包发射至基于云的计算机资源的传送,以进一步处理和操纵由装置1a-1n/2a-2m中的任一者或所有收集的数据。可采用网络路由器211来连接位于不同位置的两个或更多个不同的网络,诸如例如同一医疗设施的不同手术室或位于不同医疗设施的不同手术室的不同网络。网络路由器211以包的形式向云204发送数据并且以全双工模式工作。多个装置可以同时发送数据。网络路由器211使用IP地址来传输数据。
在一个示例中,网络集线器207可被实现为USB集线器,其允许多个USB装置连接到主机。USB集线器可以将单个USB端口扩展到多个层级,以便有更多端口可用于将装置连接到主机系统计算机。网络集线器207可包括用于通过有线信道或无线信道接收信息的有线或无线能力。在一个方面,无线USB短距离、高带宽无线无线电通信协议可用于装置1a-1n和位于手术室中的装置2a-2m之间的通信。
在其他示例中,手术室装置1a-1n/2a-2m可经由蓝牙无线技术标准与模块化通信集线器203通信,以用于在短距离(使用ISM频带中的2.4至2.485GHz的短波长UHF无线电波)从固定装置和移动装置交换数据以及构建个人局域网(PAN)。在其它方面,手术室装置1a-1n/2a-2m可经由多种无线或有线通信标准或协议与模块化通信集线器203通信,包括但不限于Wi-Fi(IEEE 802.11系列)、WiMAX(IEEE 802.16系列)、IEEE 802.20、长期演进(LTE)和Ev-DO、HSPA+、HSDPA+、HSUPA+、EDGE、GSM、GPRS、CDMA、TDMA、DECT、及其以太网衍生物、以及指定为3G、4G、5G和以上的任何其它无线和有线协议。该计算模块可包括多个通信模块。例如,第一通信模块可专用于较短距离的无线通信诸如Wi-Fi和蓝牙,并且第二通信模块可专用于较长距离的无线通信,诸如GPS、EDGE、GPRS、CDMA、WiMAX、LTE、Ev-DO等。
模块化通信集线器203可用作手术室装置1a-1n/2a-2m中的一者或全部的中心连接,并且处理被称为帧的数据类型。帧携带由装置1a-1n/2a-2m生成的数据。当模块化通信集线器203接收帧时,该帧被放大并传输到网络路由器211,该网络路由器通过使用如本文所述的多个无线或有线通信标准或协议将数据传输到云计算资源。
模块化通信集线器203可用作独立装置或连接到兼容的网络集线器和网络交换机以形成更大的网络。模块化通信集线器203通常易于安装、配置和维护,使得其成为对手术室装置1a-1n/2a-2m进行联网的良好选项。
图9示出了计算机实现的交互式外科系统200。计算机实现的交互式外科系统200在许多方面类似于计算机实现的交互式外科系统100。例如,计算机实现的交互式外科系统200包括在许多方面类似于外科系统102的一个或多个外科系统202。每个外科系统202包括与可包括远程服务器213的云204通信的至少一个外科集线器206。在一个方面,计算机实现的交互式外科系统200包括模块化控制塔236,该模块化控制塔236连接到多个手术室装置,诸如例如智能外科器械、机器人和位于手术室中的其它计算机化装置。如图10中所示,模块化控制塔236包括联接到计算机系统210的模块化通信集线器203。如图9的示例中所示,模块化控制塔236联接到与内窥镜239联接的成像模块238、与能量装置241联接的发生器模块240、排烟器模块226、抽吸/冲洗模块228、通信模块230、处理器模块232、存储阵列234、任选地联接到显示器237的智能装置/器械235和非接触传感器模块242。手术室装置经由模块化控制塔236联接到云计算资源和数据存储。机器人集线器222也可连接到模块化控制塔236和云计算资源。装置/器械235、可视化系统208等等可经由有线或无线通信标准或协议联接到模块化控制塔236,如本文所述。模块化控制塔236可联接到集线器显示器215(例如,监测器、屏幕)以显示和叠加从成像模块、装置/器械显示器和/或其他可视化系统208接收的图像。集线器显示器还可结合图像和叠加图像来显示从连接到模块化控制塔的装置接收的数据。
图10示出了包括联接到模块化控制塔236的多个模块的外科集线器206。模块化控制塔236包括模块化通信集线器203(例如,网络连接性装置)和计算机系统210,以提供例如本地处理、可视化和成像。如图10中所示,模块化通信集线器203可以分层配置连接以扩展可连接到模块化通信集线器203的模块(例如,装置)的数量,并将与模块相关联的数据传输至计算机系统210、云计算资源或两者。如图10中所示,模块化通信集线器203中的网络集线器/交换机中的每个包括三个下游端口和一个上游端口。上游网络集线器/交换机连接至处理器以提供与云计算资源和本地显示器217的通信连接。与云204的通信可通过有线或无线通信信道进行。
外科集线器206采用非接触传感器模块242来测量手术室的尺寸,并且使用超声或激光型非接触测量装置来生成外科室的标测图。基于超声的非接触传感器模块通过发射一阵超声波并在其从手术室的围墙弹回时接收回波来扫描手术室,如在2017年12月28日提交的名称为“INTERACTIVE SURGICAL PLATFORM”的美国临时专利申请序列号62/611,341中的标题“Surgical Hub Spatial Awareness Within an Operating Room”下所述,该临时专利申请全文以引用方式并入本文,其中传感器模块被配置为确定手术室的大小并调节蓝牙配对距离限制。基于激光的非接触传感器模块通过发射激光脉冲、接收从手术室的围墙弹回的激光脉冲,以及将发射脉冲的相位与所接收的脉冲进行比较来扫描手术室,以确定手术室的大小并调节蓝牙配对距离限制。
计算机系统210包括处理器244和网络接口245。处理器244经由系统总线联接到通信模块247、存储装置248、存储器249、非易失性存储器250和输入/输出接口251。系统总线可为若干类型的总线结构中的任一者,该总线结构包括存储器总线或存储器控制器、外围总线或外部总线、和/或使用任何各种可用总线架构的本地总线,包括但不限于9位总线、工业标准架构(ISA)、微型Charmel架构(MSA)、扩展ISA(EISA)、智能驱动电子器件(IDE)、VESA本地总线(VLB)、外围器件互连(PCI)、USB、高级图形端口(AGP)、个人计算机存储卡国际协会总线(PCMCIA)、小型计算机系统接口(SCSI)或任何其他外围总线。
控制器244可为任何单核或多核处理器,诸如由德克萨斯器械公司(TexasInstruments)提供的商品名为ARM Cortex的那些处理器。在一个方面,处理器可为购自例如德克萨斯器械公司的LM4F230H5QR ARM Cortex-M4F处理器核心,其包括256KB的单循环闪存或其它非易失性存储器(最多至40MHZ)的片上存储器、用于改善40MHz以上的性能的预取缓冲器、32KB单循环序列随机存取存储器(SRAM)、装载有软件的内部只读存储器(ROM)、2KB电可擦除可编程只读存储器(EEPROM)、和/或一个或多个脉宽调制(PWM)模块、一个或多个正交编码器输入(QEI)模拟部、具有12个模拟输入信道的一个或多个12位模数转换器(ADC),其细节可见于产品数据表。
在一个方面,处理器244可包括安全控制器,该安全控制器包括两个基于控制器的系列(诸如TMS570和RM4x),已知同样由德克萨斯器械公司生产的商品名为Hercules ARMCortex R4。安全控制器可被配置为专门用于IEC 61508和ISO 26262安全关键应用等等,以提供先进的集成安全特征结构,同时递送可定标的性能、连接性和存储器选项。
系统存储器包括易失性存储器和非易失性存储器。基本输入/输出系统(BIOS)(包含诸如在启动期间在计算机系统内的元件之间传输信息的基本例程,)存储在非易失性存储器中。例如,非易失性存储器可包括ROM、可编程ROM(PROM)、电可编程ROM(EPROM)、EEPROM或闪存。易失存储器包括充当外部高速缓存存储器的随机存取存储器(RAM)。此外,RAM可以多种形式可用,诸如SRAM、动态RAM(DRAM)、同步DRAM(SDRAM)、双数据速率SDRAM(DDRSDRAM)増强SDRAM(ESDRAM)、同步链路DRAM(SLDRAM)和直接Rambus RAM(DRRAM)。
计算机系统210还包括可移除/不可移除的、易失性/非易失性的计算机存储介质,诸如例如磁盘存储器。磁盘存储器包括但不限于诸如装置如磁盘驱动器、软盘驱动器、磁带驱动器、Jaz驱动器、Zip驱动器、LS-60驱动器、闪存存储卡或内存条。此外,磁盘存储器可包括单独地或与其它存储介质组合的存储介质,包括但不限于光盘驱动器诸如光盘ROM装置(CD-ROM)、光盘可记录驱动器(CD-R驱动器)、光盘可重写驱动器(CD-RW驱动器)或数字通用磁盘ROM驱动器(DVD-ROM)。为了有利于磁盘存储装置与系统总线的连接,可使用可移除或非可移除接口。
应当理解,计算机系统210包括充当用户与在合适的操作环境中描述的基本计算机资源之间的中介的软件。此类软件包括操作系统。可存储在磁盘存储装置上的操作系统用于控制并分配计算机系统的资源。系统应用程序利用操作系统通过存储在系统存储器或磁盘存储装置中的程序模块和程序数据来管理资源。应当理解,本文所述的各种器件可用各种操作系统或操作系统的组合来实现。
用户通过联接到I/O接口251的(一个或多个)输入装置将命令或信息输入到计算机系统210中。输入装置包括但不限于指向装置,诸如鼠标、触控球、触笔、触摸板、键盘、麦克风、操纵杆、游戏垫、卫星盘、扫描仪、电视调谐器卡、数字相机、数字摄像机、幅材相机等。这些和其它输入装置经由(一个或多个)接口端口通过系统总线连接到处理器。(一个或多个)接口端口包括例如串口、并行端口、游戏端口和USB。(一个或多个)输出装置使用与(一个或多个)输入装置相同类型的端口。因此,例如,USB端口可用于向计算机系统提供输入并将信息从计算机系统输出到输出装置。提供了输出适配器来说明在其它输出装置中存在需要特殊适配器的一些输出装置(如监测器、显示器、扬声器和打印机。输出适配器以举例的方式包括但不限于提供输出装置和系统总线之间的连接装置的视频和声卡。应当指出,其它装置或装置诸如(一个或多个)远程计算机的系统提供了输入能力和输出能力两者。
计算机系统210可使用与一个或多个远程计算机(诸如(一个或多个)云计算机)或本地计算机的逻辑连接在联网环境中操作。(一个或多个)远程云计算机可为个人计算机、服务器、路由器、网络PC、工作站、基于微处理器的器具、对等装置或其它公共网络节点等,并且通常包括相对于计算机系统所述的元件中的许多或全部。为简明起见,仅示出了具有(一个或多个)远程计算机的存储器存储装置。(一个或多个)远程计算机通过网络接口在逻辑上连接到计算机系统,并且然后经由通信连接物理连接。网络接口涵盖通信网络诸如局域网(LAN)和广域网(WAN)。LAN技术包括光纤分布式数据接口(FDDI)、铜分布式数据接口(CDDI)、以太网/IEEE 802.3、令牌环/IEEE 802.5等。WAN技术包括但不限于点对点链路、电路交换网络如综合业务数字网络(ISDN)及其变体、分组交换网络和数字用户管线(DSL)。
在各种方面,图10的计算机系统210、成像模块238和/或可视化系统208以及/或者图9至图10的处理器模块232可包括图像处理器、图像处理引擎、媒体处理器、或用于处理数字图像的任何专用数字信号处理器(DSP)。图像处理器可采用具有单个指令、多数据(SIMD)或多指令、多数据(MIMD)技术的并行计算以提高速度和效率。数字图像处理引擎可执行一系列任务。图像处理器可为具有多核处理器架构的芯片上的系统。
一个或多个通信连接是指用于将网络接口连接到总线的硬件/软件。虽然示出了通信连接以便在计算机系统内进行示例性澄清,但其也可位于计算机系统210的外部。连接到网络接口所必需的硬件/软件仅出于示例性目的包括内部和外部技术,诸如调制解调器,包括常规的电话级调制解调器、电缆调制解调器和DSL调制解调器、ISDN适配器和以太网卡。
图11示出了根据本公开的一个方面的USB网络集线器300装置的一个方面的功能框图。在例示的方面,USB网络集线器装置300采用德克萨斯器械公司的TUSB2036集成电路集线器。USB网络集线器300是根据USB 2.0规范提供上游USB收发器端口302和多达三个下游USB收发器端口304、306、308的CMOS装置。上游USB收发器端口302为差分根数据端口,其包括与差分数据正(DM0)输入配对的差分数据负(DP0)输入。三个下游USB收发器端口304、306、308为差分数据端口,其中每个端口包括与差分数据负(DM1-DM3)输出配对的差分数据正(DP1-DP3)输出。
USB网络集线器300装置用数字状态机而不是微控制器来实现,并且不需要固件编程。完全兼容的USB收发器集成到用于上游USB收发器端口302和所有下游USB收发器端口304、306、308的电路中。下游USB收发器端口304、306、308通过根据附接到端口的装置的速度自动设定转换速率来支持全速度装置和低速装置两者。USB网络集线器300装置可被配置为处于总线供电模式或自供电模式,并且包括集线器功率逻辑312以管理功率。
USB网络集线器300装置包括串行接口引擎310(SIE)。SIE 310是USB网络集线器300硬件的前端,并处理USB规范第8章中描述的大多数协议。SIE 310通常包括多达交易级别的信令。其处理的功能可包括:包识别、事务排序、SOP、EOP、RESET和RESUME信号检测/生成、时钟/数据分离、不返回到零反转(NRZI)数据编码/解码和数位填充、CRC生成和校验(令牌和数据)、包ID(PID)生成和校验/解码、和/或串行并行/并行串行转换。310接收时钟输入314并且联接到暂停/恢复逻辑和帧定时器316电路以及集线器中继器电路318,以通过端口逻辑电路320、322、324控制上游USB收发器端口302和下游USB收发器端口304、306、308之间的通信。SIE 310经由接口逻辑联接到命令解码器326,以经由串行EEPROM接口330来控制来自串行EEPROM的命令。
在各种方面,USB网络集线器300可将配置在多达六个逻辑层(层级)中的127功能连接至单个计算机。此外,USB网络集线器300可使用提供通信和电力分配两者的标准化四线电缆连接到所有外装置。功率配置为总线供电模式和自供电模式。USB网络集线器300可被配置为支持四种功率管理模式:具有单独端口功率管理或成套端口功率管理的总线供电集线器,以及具有单独端口功率管理或成套端口功率管理的自供电集线器。在一个方面,使用USB电缆将USB网络集线器300、上游USB收发器端口302插入USB主机控制器中,并且将下游USB收发器端口304、306、308暴露以用于连接USB兼容装置等。
外科器械硬件
图12示出了根据本公开的一个或多个方面的外科器械或工具的控制系统470的逻辑图。系统470包括控制电路。该控制电路包括微控制器461,该微控制器包括处理器462和存储器468。例如,传感器472、474、476中的一个或多个向处理器462提供实时反馈。由马达驱动器492驱动的马达482可操作地联接纵向可移动的位移构件以驱动I形梁刀元件。跟踪系统480被配置为确定纵向可移动的位移构件的位置。将位置信息提供给处理器462,该处理器可被编程或配置为确定纵向可移动的驱动构件的位置以及击发构件、击发杆和I形梁刀元件的位置。附加马达可设置在工具驱动器接口处,以控制I形梁击发、闭合管行进、轴旋转和关节运动。显示器473显示器械的多种操作条件并且可包括用于数据输入的触摸屏功能。显示在显示器473上的信息可叠加有经由内窥镜式成像模块获取的图像。
在一个方面,微处理器461可为任何单核或多核处理器,诸如已知的由德克萨斯器械公司生产的商品名为ARM Cortex的那些。在一个方面,微控制器461可为购自例如德克萨斯器械公司的LM4F230H5QR ARM Cortex-M4F处理器核心,其例如包括256KB的单循环闪存或其他非易失性存储器(最多至40MHZ)的片上存储器、用于改善40MHz以上的性能的预取缓冲器、32KB单循环SRAM、装载有软件的内部ROM、2KB电EEPROM、一个或多个PWM模块、一个或多个QEI模拟部、具有12个模拟输入信道的一个或多个12位ADC,其细节可见于产品数据表。
在一个方面,微控制器461可包括安全控制器,该安全控制器包括两个基于控制器的系列(诸如TMS570和RM4x),已知同样由德克萨斯器械公司生产的商品名为Hercules ARMCortex R4。安全控制器可被配置为专门用于IEC 61508和ISO 26262安全关键应用等等,以提供先进的集成安全特征结构,同时递送可定标的性能、连接性和存储器选项。
可对控制器461进行编程以执行各种功能,诸如对刀和关节运动系统的速度和位置的精确控制。在一个方面,微控制器461包括处理器462和存储器468。电动马达482可为有刷直流(DC)马达,其具有齿轮箱以及至关节运动或刀系统的机械链路。在一个方面,马达驱动器492可为可购自Allegro微系统公司(Allegro Microsystems,Inc)的A3941。其它马达驱动器可容易地被替换以用于包括绝对定位系统的跟踪系统480中。绝对定位系统的详细描述在2017年10月19日公布的名称为“SYSTEMS AND METHODS FOR CONTROLLING ASURGICAL STAPLING AND CUTTING INSTRUMENT”的美国专利申请公布No.2017/0296213中有所描述,该专利申请全文以引用方式并入本文。
微控制器461可被编程为提供对位移构件和关节运动系统的速度和位置的精确控制。微控制器461可被配置为计算微控制器461的软件中的响应。将计算的响应与实际系统的所测量响应进行比较,以获得“观察到的”响应,其用于实际反馈决定。观察到的响应为有利的调谐值,该值使所模拟响应的平滑连续性质与所测量响应均衡,这可检测对系统的外部影响。
在一个方面,马达482可由马达驱动器492控制并可被外科器械或工具的击发系统采用。在各种形式中,马达482可为具有大约25,000RPM的最大旋转速度的有刷直流驱动马达。在其他布置中,马达482可包括无刷马达、无绳马达、同步马达、步进马达或任何其他合适的电动马达。马达驱动器492可包括例如包括场效应晶体管(FET)的H桥驱动器。马达482可通过可释放地安装到柄部组件或工具外壳的功率组件来供电,以用于向外科器械或工具供应控制功率。功率组件可包括电池,该电池可以包括串联连接的、可用作功率源以为外科器械或工具提供电力的多个电池单元。在某些情况下,功率组件的电池单元可以是可替换的和/或可再充电的。在至少一个示例中,电池单元可为锂离子电池,其可联接到功率组件并且可与功率组件分离。
驱动器492可为可购自Allegro微系统公司(Allegro Microsystems,Inc)的A3941。A3941 492为全桥控制器,其用于与针对电感负载(诸如有刷DC马达)特别设计的外部N信道功率金属氧化物半导体场效应晶体管(MOSFET)一起使用。驱动器492包括独特的电荷泵调整器,该电荷泵调整器为低至7V的电池电压提供完整的(>10V)栅极驱动并且允许A3941在低至5.5V的减小的栅极驱动下操作。可采用自举电容器来提供N信道MOSFET所需的上述电池供电电压。高边驱动装置的内部电荷泵允许直流(100%占空比)操作。可使用二极管或同步整流在快衰减模式或慢衰减模式下驱动全桥。在慢衰减模式下,电流再循环可穿过高边或低边FET。通过电阻器可调式空载时间保护功率FET不被击穿。整体诊断提供欠压、过热和功率桥故障的指示,并且可被配置为在大多数短路条件下保护功率MOSFET。其它马达驱动器可容易地被替换以用于包括绝对定位系统的跟踪系统480中。
跟踪系统480包括根据本公开的一个方面的包括位置传感器472的受控马达驱动电路布置方式。用于绝对定位系统的位置传感器472提供对应于位移构件的位置的独特位置信号。在一个方面,位移构件表示纵向可移动的驱动构件,其包括用于与齿轮减速器组件的对应驱动齿轮啮合接合的驱动齿的齿条。在其它方面,位移构件表示击发构件,该击发构件可被适配和配置为包括驱动齿的齿条。在又一个方面,该位移构件表示击发杆或I形梁,该两者中的每一者可被适配和配置为包括驱动齿的齿条。因此,如本文所用,术语位移构件一般用来指外科器械或工具的任何可移动构件,诸如驱动构件、击发构件、击发杆、I形梁或可被移位的任何元件。在一个方面,纵向可移动的驱动构件联接到击发构件、击发杆和I形梁。因此,绝对定位系统实际上可通过跟踪纵向可移动的驱动构件的线性位移来跟踪I形梁的线性位移。在各种其它方面,位移构件可联接到适于测量线性位移的任何位置传感器472。因此,纵向可移动的驱动构件、击发构件、击发杆或I形梁或它们的组合可联接到任何合适的线性位移传感器。线性位移传感器可包括接触式位移传感器或非接触式位移传感器。线性位移传感器可包括线性可变差分变压器(LVDT)、差分可变磁阻换能器(DVRT)、滑动电位计、包括可移动磁体和一系列线性布置的霍尔效应传感器的磁感测系统、包括固定磁体和一系列可移动的线性布置的霍尔效应传感器的磁感测系统、包括可移动光源和一系列线性布置的光电二极管或光电检测器的光学感测系统、包括固定光源和一系列可移动的线性布置的光电二极管或光电检测器的光学感测系统、或它们的任何组合。
电动马达482可包括可操作地与齿轮组件交接的可旋转轴,该齿轮组件与驱动齿的组或齿条啮合接合安装在位移构件上。传感器元件可以可操作地联接到齿轮组件,使得位置传感器472元件的单次旋转对应于位移构件的一些线性纵向平移。传动装置和传感器的布置可经由齿条和小齿轮布置连接至线性致动器,或者经由直齿齿轮或其他连接件连接至旋转致动器。功率源为绝对定位系统供电,并且输出指示器可显示绝对定位系统的输出。位移构件表示纵向可移动驱动构件,该纵向可移动驱动构件包括形成于其上的驱动齿的齿条,以用于与齿轮减速器组件的对应驱动齿轮啮合接合。位移构件表示纵向可移动的击发构件、击发杆、I形梁或它们的组合。
与位置传感器472相关联的传感器元件的单次旋转等同于位移构件的纵向线性位移d1,其中d1为在联接到位移构件的传感器元件的单次旋转之后位移构件从点“a”移动到点“b”的纵向线性距离。可经由齿轮减速来连接传感器布置,该齿轮减速使得位置传感器472针对位移构件的全行程完成一次或多次旋转。位置传感器472可针对位移构件的全行程完成多次旋转。
可单独或结合齿轮减速采用一系列开关(其中n为大于一的整数)以针对位置传感器472的多于一次旋转提供独特位置信号。开关的状态被馈送回微控制器461,该微控制器应用逻辑以确定对应于位移构件的纵向线性位移d1+d2+…dn的独特位置信号。位置传感器472的输出被提供给微控制器461。该传感器布置的位置传感器472可包括磁性传感器、模拟旋转传感器(如电位差计)、或模拟霍尔效应元件的阵列,该模拟霍尔效应元件的阵列输出位置信号或值的独特组合。
位置传感器472可包括任何数量的磁性感测元件,诸如例如根据它们是否测量磁场的总磁场或矢量分量而被分类的磁性传感器。用于产生上述两种类型磁性传感器的技术涵盖物理学和电子学的多个方面。用于磁场感测的技术包括探查线圈、磁通门、光泵、核旋、超导量子干涉仪(SQUID)、霍尔效应、各向异性磁电阻、巨磁电阻、磁性隧道结、巨磁阻抗、磁致伸缩/压电复合材料、磁敏二极管、磁敏晶体管、光纤、磁光,以及基于微机电系统的磁性传感器等等。
在一个方面,用于包括绝对定位系统的跟踪系统480的位置传感器472包括磁性旋转绝对定位系统。位置传感器472可被实现为AS5055EQFT单片磁性旋转位置传感器,其可购自奥地利微系统公司(Austria Microsystems,AG)。位置传感器472与微控制器461交接,以提供绝对定位系统。位置传感器472为低电压和低功率器件,并且包括位于磁体上的位置传感器472的区域中的四个霍尔效应元件。在芯片上还提供了高分辨率ADC和智能功率管理控制器。提供了坐标旋转数字计算机(CORDIC)处理器(也被称为逐位法和Volder算法)以执行简单有效的算法来计算双曲线函数和三角函数,其仅需要加法、减法、数位位移和表格查找操作。角位置、报警位和磁场信息通过标准串行通信接口(诸如串行外围接口(SPI)接口)发射到微控制器461。位置传感器472提供12或14位分辨率。位置传感器472可为以小QFN 16引脚4mm×4mm×0.85mm封装形式提供的AS5055芯片。
包括绝对定位系统的跟踪系统480可包括并且/或者可被编程以实现反馈控制器,诸如PID、状态反馈和自适应控制器。功率源将来自反馈控制器的信号转换为对系统的物理输入:在这种情况下为电压。其它示例包括电压、电流和力的PWM。除了由位置传感器472所测量的位置之外,可提供(一个或多个)其它传感器来测量物理系统的物理参数。在一些方面,其它传感器可包括传感器布置方式,诸如在2016年5月24日发布的名称为“STAPLECARTRIDGE TISSUE THICKNESS”的美国专利9,345,481中所述的那些,该专利全文以引用方式并入本文;2014年9月18日公布的名称为“STAPLE CARTRIDGE TISSUE THICKNESS”的美国专利申请公布2014/0263552,该专利全文以引用方式并入本文;以及2017年6月20日提交的名称为“TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICALSTAPLING AND CUTTING INSTRUMENT”的美国专利申请序列号15/628,175,该专利申请全文以引用方式并入本文。在数字信号处理系统中,绝对定位系统联接到数字数据采集系统,其中绝对定位系统的输出将具有有限分辨率和采样频率。绝对定位系统可包括比较和组合电路,以使用算法(诸如加权平均和理论控制环路)将计算响应与测量响应进行组合,该算法驱动计算响应朝向所测量的响应。物理系统的计算响应将性能如质量、惯性、粘性摩擦、电感电阻考虑在内,以通过得知输入预测物理系统的状态和输出。
因此,绝对定位系统在器械上电时提供位移构件的绝对位置,并且不使位移构件回缩或推进至如常规旋转编码器可需要的复位(清零或本位)位置,这些编码器仅对马达482采取的向前或向后的步骤数进行计数以推断装置致动器、驱动棒、刀等等的位置。
传感器474(诸如,例如应变仪或微应变仪)被配置为测量端部执行器的一个或多个参数,诸如例如在夹持操作期间施加在砧座上的应变的幅值,该幅值可以指示施加到砧座的闭合力。将测得的应变转换成数字信号并提供给处理器462。另选地或除了传感器474之外,传感器476(诸如负荷传感器)可以测量由闭合驱动系统施加到砧座的闭合力。传感器476诸如例如负荷传感器可以测量在外科器械或工具的击发行程中施加到I形梁的击发力。I形梁被配置成能够接合楔形滑动件,该楔形滑动件被配置成能够使钉驱动器向上凸轮运动以将钉推出以与砧座变形接触。I形梁还包括锋利切割刃,当通过击发杆向远侧推进I形梁时,该切割刃可用于切断组织。另选地,可以采用电流传感器478来测量由马达482消耗的电流。推进击发构件所需的力可对应于例如由马达482消耗的电流。将测得的力转换成数字信号并提供给处理器462。
在一种形式中,应变仪传感器474可用于测量由端部执行器施加到组织的力。应变计可联接到端部执行器以测量被端部执行器处理的组织上的力。用于测量施加到由端部执行器抓持的组织的力的系统包括应变仪传感器474,诸如例如微应变仪,其被配置为测量例如端部执行器的一个或多个参数。在一个方面,应变仪传感器474可测量在夹持操作期间施加到端部执行器的钳口构件上的应变的振幅或量值,这可指示组织压缩。将测得的应变转换成数字信号并将其提供到微控制器461的处理器462。负载传感器476可测量用于操作刀元件例如以切割被捕获在砧座和钉仓之间的组织的力。可采用磁场传感器来测量捕集的组织的厚度。磁场传感器的测量值也可被转换成数字信号并提供给处理器462。
微控制器461可使用分别由传感器474、476测量的组织压缩、组织厚度和/或闭合端部执行器所需的力的测量值来表征击发构件的所选择的位置和/或击发构件的速度的对应值。在一个实例中,存储器468可存储可由微控制器461在评估中所采用的技术、公式和/或查找表。
外科器械或工具的控制系统470还可包括有线或无线通信电路以与模块化通信集线器通信,如图8-11中所示。
图13示出了控制电路500,该控制电路500被配置为控制根据本公开的一个方面的外科器械或工具的各方面。控制电路500可被配置为实现本文所述的各种过程。控制电路500可以包括微控制器,该微控制器包括联接到至少一个存储器电路504的一个或多个处理器502(例如,微处理器、微控制器)。存储器电路504存储在由处理器502执行时使处理器502执行机器指令以实现本文所述的各种过程的机器可执行指令。处理器502可为本领域中已知的多种单核或多核处理器中的任一种。存储器电路504可以包括易失性存储介质和非易失性存储介质。处理器502可以包括指令处理单元506和运算单元508。该指令处理单元可以被配置为从本公开的存储器电路504接收指令。
图14示出了组合逻辑电路510,该组合逻辑电路510被配置为控制根据本公开的一个方面的外科器械或工具的各方面。该组合逻辑电路510可被配置为实现本文所述的各种过程。组合逻辑电路510可包括有限状态机,该有限状态机包括组合逻辑512,该组合逻辑被配置为在输入514处接收与外科器械或工具相关联的数据,通过组合逻辑512处理该数据并提供输出516。
图15示出了根据本公开的一个方面的被配置为控制外科器械或工具的各个方面的时序逻辑电路520。时序逻辑电路520或组合逻辑522可被配置为实现本文所述的各种过程。时序逻辑电路520可包括有限状态机。时序逻辑电路520可包括例如组合逻辑522、至少一个存储器电路524和时钟529。至少一个存储器电路524可以存储有限状态机的当前状态。在某些情况下,时序逻辑电路520可以是同步的或异步的。组合逻辑522被配置为从输入526接收与外科器械或工具相关联的数据,通过组合逻辑522处理数据并提供输出528。在其它方面,电路可包括处理器(例如,处理器502,图13)和有限状态机的组合以实现本文的各种过程。在其他方面,有限状态机可以包括组合逻辑电路(例如,组合逻辑电路510,图14)和时序逻辑电路520的组合。
图16示出了包括可被激活以执行各种功能的多个马达的外科器械或工具。在某些情况下,第一马达可被激活以执行第一功能,第二马达可被激活以执行第二功能,并且第三马达可被激活以执行第三功能。在某些情况下,机器人外科器械600的多个马达可被单独地激活以引起端部执行器中的击发运动、闭合运动、和/或关节运动。击发运动、闭合运动、和/或关节运动可例如通过轴组件发射到端部执行器。
在某些情况下,外科器械系统或工具可包括击发马达602。击发马达602可操作地联接到击发马达驱动组件604,该击发马达驱动组件可被配置为将由马达602生成的击发运动传输到端部执行器,具体地用于使I形梁元件移位。在某些情况下,由马达602产生的击发运动可导致例如钉从钉仓部署到由端部执行器捕获的组织内并且/或者导致I形梁元件的切割刃被推进以切割所捕获组织。I形梁元件可通过反转马达602的方向而回缩。
在某些情况下,外科器械或工具可包括闭合马达603。闭合马达603可以可操作地联接到闭合马达驱动组件605,该闭合马达驱动组件605被配置为将由马达603生成的闭合运动传递到端部执行器,具体地用于移置闭合管以闭合砧座并且压缩砧座和钉仓之间的组织。闭合运动可使例如端部执行器从打开配置转变成接近配置以捕获组织。端部执行器可通过反转马达603的方向而转变到打开位置。
在某些情况下,外科器械或工具可包括例如一个或多个关节运动马达606a、606b。马达606a、606b可以可操作地联接到相应的关节运动马达驱动组件608a、608b,该关节运动马达驱动组件可被配置为将由马达606a、606b生成的关节运动传递到端部执行器。在某些情况下,关节运动可使端部执行器相对于轴进行关节运动,例如。
如上所述,外科器械或工具可包括多个马达,该多个马达可被配置为执行各种独立功能。在某些情况下,外科器械或工具的多个马达可被单独地或独立地激活以执行一个或多个功能,而其它马达保持非活动的。例如,关节运动马达606a、606b可被激活以使端部执行器进行关节运动,而击发马达602保持非活动的。另选地,击发马达602可被激活以击发多个钉并且/或者推进切割边缘,而关节运动马达606保持非活动的。此外,闭合马达603可与击发马达602同时启动,以使闭合管和I形梁元件朝远侧推进,如下文更详细地描述。
在某些情况下,外科器械或工具可包括公共控制模块610,该公共控制模块610可与外科器械或工具的多个马达一起使用。在某些情况下,公共控制模块610每次可调节多个马达中的一个马达。例如,公共控制模块610可单独地联接到外科器械的多个马达并且可从外科器械的多个马达分离。在某些情况下,外科器械或工具的多个马达可共用一个或多个公共控制模块诸如公共控制模块610。在某些情况下,外科器械或工具的多个马达可独立地和选择性地接合公共控制模块610。在某些情况下,公共控制模块610可从与外科器械或工具的多个马达中的一个交接切换到与外科器械或工具的多个马达中的另一个交接。
在至少一个示例中,公共控制模块610可在可操作地接合关节运动马达606a、606b与可操作地接合击发马达602或闭合马达603之间选择性地切换。在至少一个示例中,如图16中所示,开关614可在多个位置和/或状态之间移动或转变。在第一位置616中,开关614可以将公共控制模块610电联接到击发马达602;在第二位置617中,开关614可以将公共控制模块610电联接到闭合马达603;在第三位置618a中,开关614可以将公共控制模块610电联接到第一关节运动马达606a;并且在第四位置618b中,开关614可以将公共控制模块610电联接到例如第二关节运动马达606b。在某些情况下,单独的公共控制模块610可同时电联接到击发马达602、闭合马达603和关节运动马达606a、606b。在某些情况下,开关614可为机械开关、机电开关、固态开关、或任何合适的开关机构。
马达602、603、606a、606b中的每个可包括扭矩传感器以测量马达的轴上的输出扭矩。可以任何常规方式感测端部执行器上的力,诸如通过钳口的外侧上的力传感器或通过用于致动钳口的马达的扭矩传感器来感测端部执行器上的力。
在各种情况下,如图16中所示,公共控制模块610可包括马达驱动器626,该马达驱动器626可包括一个或多个H桥场效应FET。马达驱动器626可例如基于来自微控制器620(“控制器”)的输入来调节从功率源628传输到联接到公共控制模块610的马达的电力。在某些情况下,当马达联接到公共控制模块610时,可例如采用微控制器620来确定由马达消耗的电流,如上所述。
在某些情况下,微控制器620可包括微处理器622(“处理器”)和一个或多个非暂态计算机可读介质或存储单元624(“存储器”)。在某些情况下,存储器624可存储各种程序指令,该各种程序指令在被执行时可使处理器622执行本文所述的多个功能和/或计算。在某些情况下,存储器单元624中的一个或多个存储器单元可例如联接到处理器622。
在某些情况下,功率源628可例如用于为微控制器620供电。在某些情况下,功率源628可包括电池(或者“电池组”或“功率组”),诸如锂离子电池,例如。在某些情况下,电池组可被配置为可释放地安装到柄部以用于给外科器械600供电。可将多个串联的电池单元用作功率源628。在某些情况下,功率源628可为例如可替换的和/或可再充电的。
在各种情况下,处理器622可控制马达驱动器626以控制联接到公共控制器610的马达的位置、旋转方向、和/或速度。在某些情况下,处理器622可发信号通知马达驱动器626,以停止和/或停用联接到公共控制器610的马达。应当理解,如本文所用的术语“处理器”包括任何合适的微处理器、微控制器、或将计算机的中央处理单元(CPU)的功能结合在一个集成电路或至多几个集成电路上的其它基础计算装置。处理器是多用途的可编程装置,该装置接收数字数据作为输入,根据其存储器中存储的指令来处理输入,然后提供结果作为输出。因为处理器具有内部存储器,所以是顺序数字逻辑的示例。处理器的操作对象是以二进制数字系统表示的数字和符号。
在一个实例中,处理器622可为任何单核或多核处理器,诸如已知的由德克萨斯器械公司生产的商品名为ARM Cortex的那些。在某些情况下,微控制器620可以是例如可购自德克萨斯器械公司的LM4F230H5QR。在至少一个示例中,德克萨斯器械公司的LM4F230H5QR为ARM Cortex-M4F处理器芯,其包括:256KB的单循环闪存或其他非易失性存储器(最多至40MHZ)的片上存储器、用于改善40MHz以上的性能的预取缓冲器、32KB的单循环SRAM、装载有软件的内部ROM、2KB的EEPROM、一个或多个PWM模块、一个或多个QEI模拟部、具有12个模拟输入信道的一个或多个12位ADC、以及易得的其它特征。可容易地换用其它微控制器,以与模块4410一起使用。因此,本公开不应限于这一上下文。
在某些情况下,存储器624可包括用于控制可联接到公共控制器610的外科器械600的马达中的每个的程序指令。例如,存储器624可包括用于控制击发马达602、闭合马达603和关节运动马达606a、606b的程序指令。此类程序指令可使得处理器622根据来自外科器械或工具的算法或控制程序的输入来控制击发、闭合和关节运动功能。
在某些情况下,一个或多个机构和/或传感器(诸如例如传感器630)可用于警示处理器622应当在特定设定中使用的程序指令。例如,传感器630可警示处理器622使用与击发、闭合和关节运动端部执行器相关联的程序指令。在某些情况下,传感器630可包括例如可用于感测开关614的位置的位置传感器。因此,处理器622可以在例如通过传感器630检测开关614处于第一位置616时使用与击发端部执行器的I形梁相关联的程序指令;处理器622可以在例如通过传感器630检测开关614处于第二位置617时使用与闭合砧座相关联的程序指令;并且处理器622可以在例如通过传感器630检测开关614处于第三位置618a或第四位置618b时使用与使端部执行器进行关节运动相关联的程序指令。
图17是根据本公开的一个方面的被配置为操作本文所述的外科工具的机器人外科器械700的示意图。机器人外科器械700可被编程或配置为控制位移构件的远侧/近侧平移、闭合管的远侧/近侧位移、轴旋转、以及具有单个或多个关节运动驱动连杆的关节运动。在一个方面,外科器械700可被编程或配置为单独地控制击发构件、闭合构件、轴构件、和/或一个或多个关节运动构件。外科器械700包括控制电路710,该控制电路被配置为控制马达驱动的击发构件、闭合构件、轴构件、和/或一个或多个关节运动构件。
在一个方面,机器人外科器械700包括控制电路710,该控制电路被配置为经由多个马达704a-704e来控制端部执行器702的砧座716和I形梁714(包括锋利切割刃)部分,可移除钉仓718、轴740、以及一个或多个关节运动构件742a、742b。位置传感器734可被配置为向控制电路710提供I形梁714的位置反馈。其他传感器738可被配置为向控制电路710提供反馈。定时器/计数器731向控制电路710提供定时和计数信息。可提供能量源712以操作马达704a-704e,并且电流传感器736向控制电路710提供马达电流反馈。马达704a-704e可通过控制电路710在开环或闭环反馈控制中单独操作。
在一个方面,控制电路710可包括用于执行使得一个或多个处理器执行一个或多个任务的指令的一个或多个微控制器、微处理器或其它合适的处理器。在一个方面,定时器/计数器电路731向控制电路710提供输出信号,诸如耗用的时间或数字计数,以将如由位置传感器734确定的I形梁714的位置与定时器/计数器731的输出相关联,使得控制电路710可确定I形梁714在相对于起始位置的特定时间(t)或I形梁714处于相对于起始位置的特定位置时的时间(t)处的位置。定时器/计数器731可被配置为测量所耗用的时间、计数外部事件或时间外部事件。
在一个方面,控制电路710可被编程为基于一个或多个组织条件来控制端部执行器702的功能。控制电路710可以被编程为直接或间接地感测组织条件,诸如厚度,如本文所述。控制电路710可以被编程为基于组织条件选择击发控制程序或闭合控制程序。击发控制程序可以描述位移构件的远侧运动。可以选择不同的击发控制程序以更好地处理不同的组织状况。例如,当存在较厚的组织时,控制电路710可以被编程为以较低的速度和/或以较低的功率平移位移构件。当存在较薄的组织时,控制电路710可以被编程为以较高的速度和/或以较高的功率平移位移构件。闭合控制程序可控制由砧座716施加到组织的闭合力。其他控制程序控制轴740和关节运动构件742a、742b的旋转。
在一个方面,控制电路710可生成马达设定点信号。马达设定点信号可以被提供给各种马达控制器708a-708e。马达控制器708a-708e可以包括一个或多个电路,该一个或多个电路被配置为向马达704a-704e提供马达驱动信号,以驱动马达704a-704e,如本文所述。在一些示例中,马达704a-704e可为有刷DC电动马达。例如,马达704a-704e的速度可与相应的马达驱动信号成比例。在一些示例中,马达704a-704e可为无刷DC马达,并且相应的马达驱动信号可包括提供给马达704a-704e的一个或多个定子绕组的PWM信号。而且,在一些示例中,可以省略马达控制器708a-708e,并且控制电路710可以直接生成马达驱动信号。
在一些示例中,控制电路710可以针对位移构件的行程的第一开环部分初始以开环配置操作马达704a-704e中的每个马达。基于在行程的开环部分期间机器人外科器械700的响应,控制电路710可以选择处于闭环配置的击发控制程序。器械的响应可以包括在开环部分期间位移构件的平移距离、在开环部分期间耗用的时间、在开环部分期间提供给马达704a-704e中的一者的能量、马达驱动信号的脉冲宽度之和等。在开环部分之后,控制电路710可以对位移构件行程的第二部分实现所选择的击发控制程序。例如,在行程的闭环部分期间,控制电路710可以基于以闭环方式描述位移构件的位置的平移数据来调制马达704a-704e中的一者,以使位移构件以恒定速度平移。
在一个方面,马达704a-704e可从能量源712接收电力。能量源712可为由主交流功率源、电池、超级电容器或任何其它合适的能量源驱动的DC功率源。马达704a-704e可经由相应的传动装置706a-706e机械地联接到单独的可移动机械元件,诸如I形梁714、砧座716、轴740、关节运动742a和关节运动742b。传动装置706a-706e可以包括一个或多个齿轮或其它连杆器件,以将马达704a-704e联接到可移动机械元件。位置传感器734可感测I形梁714的位置。位置传感器734可为或包括能够生成指示I形梁714的位置的位置数据的任何类型的传感器。在一些示例中,位置传感器734可包括编码器,该编码器被配置为在I形梁714向远侧和向近侧平移时向控制电路710提供一系列脉冲。控制电路710可跟踪脉冲以确定I形梁714的位置。可使用其它合适的位置传感器,包括例如接近传感器。其他类型的位置传感器可提供指示I形梁714的运动的其他信号。而且,在一些示例中,可省略位置传感器734。在马达704a-704e中的任一个是步进马达的情况下,控制电路710可以通过汇总马达704已被命令执行的步骤的数量和方向来跟踪I形梁714的位置。位置传感器734可位于端部执行器702中或器械的任何其他部分处。马达704a-704e中的每个马达的输出包括用于感测力的扭矩传感器744a-744e,并且具有用于感测驱动轴的旋转的编码器。
在一个方面,控制电路710被配置为驱动击发构件诸如端部执行器702的I形梁714部分。控制电路710向马达控件708a提供马达设定点,该马达控件向马达704a提供驱动信号。马达704a的输出轴联接到扭矩传感器744a。扭矩传感器744a联接到与I形梁714联接的传动装置706a。传动装置706a包括可移动的机械元件诸如旋转元件和击发构件,以控制I形梁714沿端部执行器702的纵向轴线朝远侧和近侧的移动。在一个方面,马达704a可联接到刀齿轮组件,该刀齿轮组件包括刀齿轮减速组,该刀齿轮减速组包括第一刀驱动齿轮和第二刀驱动齿轮。扭矩传感器744a向控制电路710提供击发力反馈信号。击发力信号表示击发或移位I形梁714所需的力。位置传感器734可被配置为将I形梁714沿击发行程的位置或击发构件的位置作为反馈信号提供给控制电路710。端部执行器702可包括被配置为向控制电路710提供反馈信号的附加传感器738。当准备好使用时,控制电路710可向马达控件708a提供击发信号。响应于击发信号,马达704a可沿端部执行器702的纵向轴线将击发构件从近侧行程开始位置朝远侧驱动至行程开始位置远侧的行程结束位置。在击发构件朝远侧平移时,具有定位在远侧端部处的切割元件的I形梁714朝远侧推进以切割位于钉仓718和砧座716之间的组织。
在一个方面,控制电路710被配置为驱动闭合构件,诸如端部执行器702的砧座716部分。控制电路710向马达控件708b提供马达设定点,该马达控件向马达704b提供驱动信号。马达704b的输出轴联接到扭矩传感器744b。扭矩传感器744b联接到与砧座716联接的传动装置706b。传动装置706b包括可移动机械元件诸如旋转元件和闭合构件,以控制砧座716从打开位置和闭合位置的移动。在一个方面,马达704b联接到闭合齿轮组件,该闭合齿轮组件包括被支撑成与闭合正齿轮啮合接合的闭合减速齿轮组。扭矩传感器744b向控制电路710提供闭合力反馈信号。闭合力反馈信号表示施加到砧座716的闭合力。位置传感器734可被配置为将闭合构件的位置作为反馈信号提供给控制电路710。端部执行器702中的附加传感器738可向控制电路710提供闭合力反馈信号。可枢转砧座716被定位成与钉仓718相对。当准备好使用时,控制电路710可向马达控件708b提供闭合信号。响应于闭合信号,马达704b推进闭合构件以抓持砧座716和钉仓718之间的组织。
在一个方面,控制电路710被配置为使轴构件诸如轴740旋转,以使端部执行器702旋转。控制电路710向马达控件708c提供马达设定点,该马达控件708c向马达704c提供驱动信号。马达704c的输出轴联接到扭矩传感器744c。扭矩传感器744c联接到传动装置706c,该传动装置706c联接到轴740。传动装置706c包括可移动机械元件诸如旋转元件,以控制轴740顺时针或逆时针旋转360°以上。在一个方面,马达704c联接到旋转传动装置组件,该旋转传动装置组件包括管齿轮区段,该管齿轮区段形成于(或附接到)近侧闭合管的近侧端部上,以通过可操作地支撑在工具安装板上的旋转齿轮组件可操作地接合。扭矩传感器744c向控制电路710提供旋转力反馈信号。旋转力反馈信号表示施加到轴740上的旋转力。位置传感器734可被配置为将闭合构件的位置作为反馈信号提供给控制电路710。附加传感器738诸如轴编码器可向控制电路710提供轴740的旋转位置。
在一个方面,控制电路710被配置为使端部执行器702进行关节运动。控制电路710向马达控件708d提供马达设定点,该马达控件向马达704d提供驱动信号。马达704d的输出轴联接到扭矩传感器744d。扭矩传感器744d联接到传动装置706d,该传动装置706d联接到关节运动构件742a。传动装置706d包括可移动的机械元件诸如关节运动元件,以控制端部执行器702±65°的关节运动。在一个方面,马达704d联接到关节运动螺母,该关节运动螺母可旋转地轴颈连接在远侧脊部的近侧端部部分上并且通过关节运动齿轮组件在其上可旋转地驱动。扭矩传感器744d向控制电路710提供关节运动力反馈信号。关节运动力反馈信号表示施加到端部执行器702的关节运动力。传感器738(诸如关节运动编码器)可向控制电路710提供端部执行器702的关节运动位置。
在另一方面,机器人外科系统700的关节运动功能可包括两个关节运动构件或连杆742a、742b。这些关节运动构件742a、742b由两个马达708d、708e所驱动的机器人接口(齿条)上的单独的盘状件驱动。当提供单独的击发马达704a时,关节运动连接件742a、742b中的每一者可相对于另一个连接件进行拮抗驱动,以便在头部未运动时向头部提供阻力保持运动和负载,并且在头部进行关节运动时提供关节运动。当头部旋转时,关节运动构件742a、742b以固定的半径附接到头部。因此,当头部旋转时,推拉连接件的机械优点发生变化。机械优点的该变化对于其它关节运动连杆驱动系统可更明显。
在一个方面,一个或多个马达704a-704e可包括具有齿轮箱的有刷DC马达和与击发构件、闭合构件或关节运动构件的机械链路。另一个示例包括操作可移动机械元件诸如位移构件、关节运动连杆、闭合管和轴的电动马达704a-704e。外部影响是事物如组织、周围身体和摩擦对物理系统的未测量的、不可预测的影响。此类外部影响可被称为曳力,其相对电动马达704a-704e中的一个作用。外部影响诸如曳力可导致物理系统的操作偏离物理系统的期望操作。
在一个方面,位置传感器734可被实现为绝对定位系统。在一个方面,位置传感器734可包括磁性旋转绝对定位系统,该磁性旋转绝对定位系统被实现为AS5055EQFT单片磁性旋转位置传感器,其可购自奥地利微系统公司。位置传感器734可与控制电路710交接,以提供绝对定位系统。位置可包括位于磁体上方并联接到CORDIC处理器的霍尔效应元件,该CORDIC处理器也被已知为逐位方法和Volder算法,提供该CORDIC处理器以实现用于计算双曲线函数和三角函数的简单有效的算法,双曲线函数和三角函数仅需要加法操作、减法操作、数位位移操作和表格查找操作。
在一个方面,控制电路710可与一个或多个传感器738通信。传感器738可定位在端部执行器702上并且适于与机器人外科器械700一起操作以测量各种衍生参数,诸如间隙距离对时间、组织压缩与时间、以及砧座应变与时间。传感器738可包括磁性传感器、磁场传感器、应变仪、负荷传感器、压力传感器、力传感器、扭矩传感器、电感式传感器诸如涡流传感器、电阻式传感器、电容式传感器、光学传感器和/或用于测量端部执行器702的一个或多个参数的任何其他合适的传感器。传感器738可包括一个或多个传感器。传感器738可位于钉仓718平台上,以使用分段电极来确定组织位置。扭矩传感器744a-744e可被配置为感测力诸如击发力、闭合力和/或关节运动力等。因此,控制电路710可感测(1)远侧闭合管所经历的闭合负荷及其位置,(2)在齿条处的击发构件及其位置,(3)超声刀片718在其上具有组织的部分,以及(4)两个关节运动杆上的负载和位置。
在一个方面,一个或多个传感器738可包括应变仪诸如微应变仪,该应变仪被配置为在夹持条件期间测量砧座716中的应变的量值。应变仪提供电信号,该电信号的幅值随着应变量值而变化。传感器738可包括压力传感器,该压力传感器被配置为检测由砧座716和钉仓718之间的压缩组织的存在所生成的压力。传感器738可被配置为检测位于砧座716与钉仓718之间的组织区段的阻抗,该阻抗指示位于其间的组织的厚度和/或完全性。
在一个方面,传感器738可实现为一个或多个限位开关、机电装置、固态开关、霍尔效应装置、磁阻(MR)装置、巨磁电阻(GMR)装置、磁力计等等。在其它具体实施中,传感器738可被实现为在光的影响下操作的固态开关,诸如光学传感器、IR传感器、紫外线传感器等等。同样,开关可为固态装置,诸如晶体管(例如,FET、结型FET、MOSFET、双极型晶体管等)。在其它具体实施中,传感器738可包括无电导体开关、超声开关、加速度计和惯性传感器等等。
在一个方面,传感器738可被配置为测量由闭合驱动系统施加在砧座716上的力。例如,一个或多个传感器738可位于闭合管和砧座716之间的交互点处,以检测由闭合管施加到砧座716的闭合力。施加在砧座716上的力可表示在砧座716和钉仓718之间捕获的组织区段所经历的组织压缩。一个或多个传感器738可沿闭合驱动系统定位在各种交互点处,以检测由闭合驱动系统施加到砧座716的闭合力。一个或多个传感器738可在夹持操作期间由控制电路710的处理器实时取样。控制电路710接收实时样本测量值以提供和分析基于时间的信息,并实时评估施加到砧座716的闭合力。
在一个方面,电流传感器736可用于测量由马达704a-704e中的每个所消耗的电流。推进可移动的机械元件(诸如I形梁714)中的任一者所需的力对应于由马达704a-704e中的一者所消耗的电流。将该力转换成数字信号并将其提供给处理电路710。控制电路710可被配置为模拟器械的实际系统在控制器的软件中的响应。可致动位移构件以将端部执行器702中的I形梁714以目标速度或接近目标速度移动。机器人外科器械700可包括反馈控制器,该反馈控制器可为任何反馈控制器中的一者,包括但不限于例如PID、状态反馈、线性平方(LQR)和/或自适应控制器。机器人外科器械700可包括功率源,以例如将来自反馈控制器的信号转换成物理输入,诸如外壳电压、PWM电压、频率调制电压、电流、扭矩和/或力。附加细节公开于2017年6月29日提交的名称为“CLOSED LOOP VELOCITY CONTROL TECHNIQUESFOR ROBOTIC SURGICAL INSTRUMENT”的美国专利申请序列号15/636,829中,该专利全文以引用方式并入本文。
图18示出根据本公开的一个方面的被编程为控制位移构件的远侧平移的外科器械750的框图。在一个方面,外科器械750被编程为控制位移构件诸如I形梁764的远侧平移。外科器械750包括端部执行器752,该端部执行器可包括砧座766、I形梁764(包括锋利切割刃)和可移除钉仓768。
线性位移构件诸如I形梁764的位置、移动、位移和/或平移可通过绝对定位系统、传感器布置和位置传感器784来测量。由于I形梁764联接到纵向可移动的驱动构件,因此I形梁764的位置可通过采用位置传感器784测量纵向可移动的驱动构件的位置来确定。因此,在以下描述中,I形梁764的位置、位移和/或平移可通过如本文所述的位置传感器784来实现。控制电路760可以被编程为控制位移构件诸如I形梁764的平移。在一些示例中,控制电路760可包括一个或多个微控制器、微处理器或其他合适的处理器,以用于执行使一个或多个处理器以所述方式控制位移构件(例如,I形梁764)的指令。在一个方面,定时器/计数器781向控制电路760提供输出信号,诸如耗用的时间或数字计数,以将如由位置传感器784确定的I形梁764的位置与定时器/计数器781的输出相关联,使得控制电路760可确定I形梁764在相对于起始位置的特定时间(t)处的位置。定时器/计数器781可被配置为测量耗用的时间、对外部事件计数或对外部事件定时。
控制电路760可生成马达设定点信号772。马达设定点信号772可被提供给马达控制器758。马达控制器758可包括一个或多个电路,该一个或多个电路被配置为向马达754提供马达驱动信号774,以驱动马达754,如本文所述。在一些示例中,马达754可为有刷DC电动马达。例如,马达754的速度可与马达驱动信号774成比例。在一些示例中,马达754可为无刷DC电动马达,并且马达驱动信号774可以包括提供给马达754的一个或多个定子绕组的PWM信号。而且,在一些示例中,可以省略马达控制器758,并且控制电路760可以直接生成马达驱动信号774。
马达754可从能量源762处接收电力。能量源762可以是或包括电池、超级电容器或任何其它合适的能量源。马达754可经由传动装置756机械地联接到I形梁764。传动装置756可包括一个或多个齿轮或其他连杆部件,以将马达754联接到I形梁764。位置传感器784可感测I形梁764的位置。位置传感器784可为或包括能够生成指示I形梁764的位置的位置数据的任何类型的传感器。在一些示例中,位置传感器784可包括编码器,该编码器被配置为在I形梁764向远侧和向近侧平移时向控制电路760提供一系列脉冲。控制电路760可跟踪这些脉冲以确定I形梁764的位置。可使用其它合适的位置传感器,包括例如接近传感器。其他类型的位置传感器可提供指示I形梁764的运动的其他信号。而且,在一些示例中,可省略位置传感器784。在马达754是步进马达的情况下,控制电路760可通过汇总马达754已被指示执行的步骤的数量和方向来跟踪I形梁764的位置。位置传感器784可位于端部执行器752中或器械的任何其他部分处。
控制电路760可与一个或多个传感器788通信。传感器788可定位在端部执行器752上并且适于与外科器械750一起操作以测量各种衍生参数,诸如间隙距离与时间、组织压缩与时间、以及砧座应变与时间。传感器788可包括磁性传感器、磁场传感器、应变仪、压力传感器、力传感器、电感式传感器(诸如涡流传感器)、电阻式传感器、电容式传感器、光学传感器、和/或用于测量端部执行器752的一个或多个参数的任何其他合适的传感器。传感器788可包括一个或多个传感器。
一个或多个传感器788可包括应变仪诸如微应变仪,该应变仪被配置为在夹持条件期间测量砧座766中的应变的量值。应变仪提供电信号,该电信号的幅值随着应变量值而变化。传感器788可包括压力传感器,该压力传感器被配置为检测由砧座766和钉仓768之间的压缩组织的存在所生成的压力。传感器788可被配置为检测位于砧座766与钉仓768之间的组织区段的阻抗,该阻抗指示位于其间的组织的厚度和/或完全性。
传感器788可被配置为测量由闭合驱动系统施加在砧座766上的力。例如,一个或多个传感器788可位于闭合管和砧座766之间的交互点处,以检测由闭合管施加到砧座766的闭合力。施加在砧座766上的力可表示在砧座766和钉仓768之间捕获的组织区段所经历的组织压缩。一个或多个传感器788可沿闭合驱动系统定位在各种交互点处,以检测由闭合驱动系统施加到砧座766的闭合力。一个或多个传感器788可在夹持操作期间由控制电路760的处理器实时取样。控制电路760接收实时样本测量值以提供和分析基于时间的信息,并实时评估施加到砧座766的闭合力。
可以采用电流传感器786来测量由马达754消耗的电流。推进I形梁764所需的力对应于由马达754消耗的电流。将该力转换成数字信号并将其提供给控制电路760。
控制电路760可被配置为模拟器械的实际系统在控制器的软件中的响应。可致动位移构件以将端部执行器752中的I形梁764以目标速度或接近目标速度移动。外科器械750可包括反馈控制器,该反馈控制器可以是任何反馈控制器中的一者,包括但不限于例如PID、状态反馈、LQR和/或自适应控制器。
外科器械750可包括功率源,以例如将来自反馈控制器的信号转换为物理输入,诸如外壳电压、PWM电压、频率调制电压、电流、扭矩和/或力。
外科器械750的实际驱动系统被配置为通过具有齿轮箱和与关节运动和/或刀系统的机械连接件的有刷直流马达来驱动位移构件、切割构件或I形梁764。另一示例为操作例如可互换轴组件的位移构件和关节运动驱动器的电动马达754。外部影响是事物如组织、周围身体和摩擦对物理系统的未测量的、不可预测的影响。这种外部影响可被称为相对电动马达754作用的曳力。外部影响诸如曳力可导致物理系统的操作偏离物理系统的期望操作。
各种示例性方面涉及外科器械750,外科器械750包括带有马达驱动的外科密封和切割工具的端部执行器752。例如,马达754可沿端部执行器752的纵向轴线向远侧和向近侧驱动位移构件。端部执行器752可包括可枢转砧座766,并且当被配置为用于使用时,钉仓768被定位成与砧座766相对。临床医生可握持砧座766与钉仓768之间的组织,如本文所述。当准备好使用器械750时,临床医生可例如通过按下器械750的触发器来提供击发信号。响应于该击发信号,马达754可沿着端部执行器752的纵向轴线将位移构件从近侧行程开始位置朝远侧驱动到行程开始位置远侧的行程结束位置。当位移构件朝远侧平移时,带有定位在远侧端部处的切割元件的I形梁764可切割钉仓768与砧座766之间的组织。
在各种示例中,外科器械750可包括控制电路760,该控制电路被编程用于基于一个或多个组织条件控制位移构件(诸如I形梁764)的远侧平移。控制电路760可以被编程为直接或间接地感测组织条件,诸如厚度,如本文所述。控制电路760可被编程为基于组织条件来选择击发控制程序。击发控制程序可以描述位移构件的远侧运动。可以选择不同的击发控制程序以更好地处理不同的组织状况。例如,当存在较厚的组织时,控制电路760可以被编程为以较低的速度和/或以较低的功率平移位移构件。当存在较薄的组织时,控制电路760可以被编程为以较高的速度和/或以较高的功率平移位移构件。
在一些示例中,控制电路760可针对位移构件的行程的第一开环部分初始以开环构型来操作马达754。基于在行程的开环部分期间器械750的响应,控制电路760可选择击发控制程序。器械的响应可以包括在开环部分期间位移构件的平移距离、在开环部分期间耗用的时间、在开环部分期间提供给马达754的能量、马达驱动信号的脉冲宽度之和等。在开环部分之后,控制电路760可以对位移构件行程的第二部分实施所选择的击发控制程序。例如,在行程的闭环部分期间,控制电路760可基于以闭环方式描述位移构件的位置的平移数据来调节马达754,以使位移构件以恒定速度平移。附加细节公开于2017年9月29日提交的名称为“SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT”的美国专利申请序列号15/720,852中,该专利申请全文以引用方式并入本文。
图19是根据本公开的一个方面的被配置为控制各种功能的外科器械790的示意图。在一个方面,外科器械790被编程为控制位移构件诸如I形梁764的远侧平移。外科器械790包括端部执行器792,该端部执行器可以包括砧座766、I形梁764和可移除钉仓768,该可移除钉仓可以与RF仓796(以虚线示出)互换。
在一个方面,传感器788可被实现为限位开关、机电装置、固态开关、霍尔效应装置、MR装置、GMR装置、磁力计等等。在其它具体实施中,传感器638可被实现为在光的影响下操作的固态开关,诸如光学传感器、IR传感器、紫外线传感器等等。同样,开关可为固态装置,诸如晶体管(例如,FET、结型FET、MOSFET、双极型晶体管等)。在其他具体实施中,传感器788可包括无电导体开关、超声开关、加速度计和惯性传感器等等。
在一个方面,位置传感器784可被实现为绝对定位系统,该绝对定位系统包括被实现为AS5055EQFT单片磁性旋转位置传感器,其可购自奥地利微系统公司(AustriaMicrosystems,AG)。位置传感器784与控制电路760交接,以提供绝对定位系统。该位置可包括位于磁体上方并联接到CORDIC处理器的多个霍尔效应元件,该CORDIC处理器也被已知为逐位方法和Volder算法,提供该CORDIC处理器以实现用于计算双曲线函数和三角函数的简单有效的算法,双曲线函数和三角函数仅需要加法操作、减法操作、数位位移操作和表格查找操作。
在一个方面,I形梁764可被实现为包括刀主体的刀构件,该刀主体将组织切割刀片可操作地支撑在其上,并且该I形梁还可包括砧座接合插片或特征部以及通道接合特征部或脚部。在一个方面,钉仓768可被实现为标准(机械)外科紧固件仓。在一个方面,RF仓796可被实现为RF仓。这些和其他传感器布置在共同拥有的提交于2017年6月20日名称为“TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING ANDCUTTING INSTRUMENT”的美国专利申请No.15/628,175中有所描述,该专利申请全文以引用方式并入本文。
线性位移构件诸如I形梁764的位置、移动、位移和/或平移可通过绝对定位系统、传感器布置和表示为位置传感器784的位置传感器来测量。由于I形梁764联接到纵向可移动的驱动构件,因此I形梁764的位置可通过采用位置传感器784测量纵向可移动的驱动构件的位置来确定。因此,在以下描述中,I形梁764的位置、位移和/或平移可通过如本文所述的位置传感器784来实现。控制电路760可以被编程为控制位移构件诸如I形梁764的平移。在一些示例中,控制电路760可包括一个或多个微控制器、微处理器或其他合适的处理器,以用于执行使一个或多个处理器以所述方式控制位移构件(例如,I形梁764)的指令。在一个方面,定时器/计数器781向控制电路760提供输出信号,诸如耗用的时间或数字计数,以将如由位置传感器784确定的I形梁764的位置与定时器/计数器781的输出相关联,使得控制电路760可确定I形梁764在相对于起始位置的特定时间(t)处的位置。定时器/计数器781可被配置为测量耗用的时间、对外部事件计数或对外部事件定时。
控制电路760可生成马达设定点信号772。马达设定点信号772可被提供给马达控制器758。马达控制器758可包括一个或多个电路,该一个或多个电路被配置为向马达754提供马达驱动信号774,以驱动马达754,如本文所述。在一些示例中,马达754可为有刷直流电动马达。例如,马达754的速度可与马达驱动信号774成比例。在一些示例中,马达754可为无刷DC电动马达,并且马达驱动信号774可以包括提供给马达754的一个或多个定子绕组的PWM信号。而且,在一些示例中,可以省略马达控制器758,并且控制电路760可以直接生成马达驱动信号774。
马达754可从能量源762处接收电力。能量源762可以是或包括电池、超级电容器或任何其它合适的能量源。马达754可经由传动装置756机械地联接到I形梁764。传动装置756可包括一个或多个齿轮或其他连杆部件,以将马达754联接到I形梁764。位置传感器784可感测I形梁764的位置。位置传感器784可为或包括能够生成指示I形梁764的位置的位置数据的任何类型的传感器。在一些示例中,位置传感器784可包括编码器,该编码器被配置为在I形梁764向远侧和向近侧平移时向控制电路760提供一系列脉冲。控制电路760可跟踪这些脉冲以确定I形梁764的位置。可使用其它合适的位置传感器,包括例如接近传感器。其他类型的位置传感器可提供指示I形梁764的运动的其他信号。而且,在一些示例中,可省略位置传感器784。在马达754是步进马达的情况下,控制电路760可通过汇总该马达已被指示执行的步骤的数量和方向来跟踪I形梁764的位置。位置传感器784可位于端部执行器792中或器械的任何其他部分处。
控制电路760可与一个或多个传感器788通信。传感器788可定位在端部执行器792上并且适于与外科器械790一起操作以测量各种衍生参数,诸如间隙距离与时间、组织压缩与时间、以及砧座应变与时间。传感器788可包括磁性传感器、磁场传感器、应变仪、压力传感器、力传感器、电感式传感器(诸如涡流传感器)、电阻式传感器、电容式传感器、光学传感器、和/或用于测量端部执行器792的一个或多个参数的任何其他合适的传感器。传感器788可包括一个或多个传感器。
一个或多个传感器788可包括应变仪诸如微应变仪,该应变仪被配置为在夹持条件期间测量砧座766中的应变的量值。应变仪提供电信号,该电信号的幅值随着应变量值而变化。传感器788可包括压力传感器,该压力传感器被配置为检测由砧座766和钉仓768之间的压缩组织的存在所生成的压力。传感器788可被配置为检测位于砧座766与钉仓768之间的组织区段的阻抗,该阻抗指示位于其间的组织的厚度和/或完全性。
传感器788可被配置为测量由闭合驱动系统施加在砧座766上的力。例如,一个或多个传感器788可位于闭合管和砧座766之间的交互点处,以检测由闭合管施加到砧座766的闭合力。施加在砧座766上的力可表示在砧座766和钉仓768之间捕获的组织区段所经历的组织压缩。一个或多个传感器788可沿闭合驱动系统定位在各种交互点处,以检测由闭合驱动系统施加到砧座766的闭合力。一个或多个传感器788可在夹持操作期间由控制电路760的处理器部分实时取样。控制电路760接收实时样本测量值以提供和分析基于时间的信息,并实时评估施加到砧座766的闭合力。
可以采用电流传感器786来测量由马达754消耗的电流。推进I形梁764所需的力对应于由马达754消耗的电流。将该力转换成数字信号并将其提供给控制电路760。
当RF仓796代替钉仓768被装载在端部执行器792中时,RF能量源794联接到端部执行器792并且被施加到RF仓796。控制电路760控制RF能量到RF仓796的递送。
附加细节公开于2017年6月28日提交的美国专利申请序列号15/636,096,其名称为“SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCYCARTRIDGE,AND METHOD OF USING SAME”,该专利全文以引用方式并入本文。
发生器硬件
图20为被配置为除了其他有益效果之外还提供无电感器调谐的发生器800的简化框图。发生器800的附加细节在公布于2015年6月23日的名称为“SURGICAL GENERATOR FORULTRASONIC AND ELECTROSURGICAL DEVICES”的美国专利No.9,060,775中有所描述,该专利全文以引用方式并入本文。发生器800可包括患者隔离台802,该患者隔离台经由功率变压器806与非隔离台804通信。功率变压器806的次级绕组808包含在隔离台802中,并且可包括分接配置(例如,中心分接或非中心分接配置)以限定驱动信号输出810a、810b、810c,以用于将驱动信号递送至不同的外科器械,诸如例如超声外科器械、RF电外科器械和包括能够单独递送或同时递送的超声能量模式和RF能量模式的多功能外科器械。具体地,驱动信号输出810a、810c可将超声驱动信号(例如,420V均方根(RMS)驱动信号)输出至超声外科器械,且驱动信号输出810b、810c可将RF电外科驱动信号(例如,100V RMS驱动信号)输出至电外科器械,其中驱动信号输出810b对应于功率变压器806的中心抽头。
在某些形式中,超声驱动信号和电外科驱动信号可同时提供至不同的外科器械和/或具有将超声能和电外科能两者递送至组织的能力的单个外科器械,诸如多功能外科器械。应当理解,提供至专用电外科器械和/或提供至组合多功能超声/电外科器械的电外科信号可以是治疗电平信号或亚治疗电平信号,其中可以使用亚治疗信号来例如监视组织或器械状况并向发生器提供反馈。例如,超声信号和RF信号可从具有单个输出端口的发生器分别或同时递送,以便向外科器械提供期望的输出信号,如将在下文更详细地讨论。因此,发生器可组合超声能量和电外科RF能量并且将组合的能量递送到多功能超声/电外科器械。双极电极可被放置在端部执行器的一个或两个钳口上。除了电外科RF能量之外,一个钳口可由超声能量同时驱动。超声能量可用于解剖组织,而电外科RF能量可用于脉管密封。
非隔离台804可包括功率放大器812,该功率放大器具有连接到功率变压器806的初级绕组814的输出部。在某些形式中,功率放大器812可包括推挽放大器。例如,非隔离台804还可包括逻辑装置816,以用于向数模转换器(DAC)电路818提供数字输出,该数字/模拟转换器(DAC)电路继而向功率放大器812的输入部提供对应的模拟信号。在某些形式中,例如除其他逻辑电路之外,逻辑装置816可包括可编程门阵列(PGA)、FPGA、可编程逻辑装置(PLD)。因此,由于经由DAC电路818控制功率放大器812的输入部,逻辑装置816可控制在驱动信号输出810a、810b、810c处出现的驱动信号的多个参数(例如,频率、波形形状、波形振幅)中的任一个参数。在某些形式中,如下所述,逻辑装置816结合处理器(例如,以下讨论的DSP)可实现多个基于DSP的算法和/或其他控制算法,以控制由发生器800输出的驱动信号的参数。
可通过开关模式调节器820(例如,功率转换器)向功率放大器812的功率轨提供功率。在某些形式中,开关模式调节器820例如可包括可调式降压调节器。非隔离台804还可包括第一处理器822,例如,在一种形式中,第一处理器可包括DSP处理器,诸如可购自AnalogDevices(Norwood,MA)的Analog Devices ADSP-21469SHARC DSP,但可在各种形式中采用任何合适的处理器。在某些形式中,DSP处理器822可响应于由DSP处理器822经由ADC电路824从功率放大器812接收的电压反馈数据来控制对开关模式调节器820的操作。在一种形式中,例如,DSP处理器822可经由ADC电路824接收由功率放大器812放大的信号(例如,射频信号)的波形包络作为输入。随后,DSP处理器822可控制开关模式调节器820(例如,经由PWM输出),使得被提供至功率放大器812的干线电压跟踪放大信号的波形包络。通过基于波形包络以动态方式调制功率放大器812的干线电压,功率放大器812的效率相对于固定干线电压放大器方案可显著改善。
在某些形式中,逻辑装置816结合DSP处理器822可实施数字合成电路诸如直接数字合成器控制方案,以控制由发生器800输出的驱动信号的波形形状、频率和/或振幅。在一种形式中,例如逻辑装置816可通过调用存储于动态更新的查找表(LUT)(诸如RAM LUT)中的波形样本来实施DDS控制算法,该动态更新的查找表可被嵌入FPGA中。该控制算法尤其可用于如下超声应用,其中超声换能器诸如超声换能器可由其谐振频率下的纯正弦式电流驱动。因为其它频率可激发寄生谐振,因此最小化或降低动态支路电流的总失真可相应地最小化或降低不利的谐振效应。因为由发生器800输出的驱动信号的波形形状受输出驱动电路(例如,功率变压器806、功率放大器812)中存在的各种畸变源的影响,所以基于驱动信号的电压和电流反馈数据可被输入至算法(诸如由DSP处理器822实施的误差控制算法)中,该算法通过适当地以动态行进方式(例如,实时)使存储于LUT中的波形样本预先畸变或修改来补偿畸变。在一种形式中,对LUT样本所施加的预先畸变量或程度可根据所计算的动态支路电流与期望的电流波形形状之间的误差而定,其中所述误差可基于逐一样本确定。以该方式,预先失真的LUT样本在通过驱动电路进行处理时,可使动态支路驱动信号具有所期望的波形形状(例如,正弦形状),以最佳地驱动超声换能器。因此,在此类形式中,当考虑到畸变效应时,LUT波形样本将不呈现驱动信号的期望波形形状,而是呈现要求最终产生动态支路驱动信号的期望波形形状的波形形状。
非隔离台804还可包括经由相应的隔离变压器830、832联接到功率变压器806的输出端的第一ADC电路826和第二ADC电路828,以用于分别对由发生器800输出的驱动信号的电压和电流进行采样。在某些形式中,ADC电路826、828可被配置为以高速(例如,80兆样本每秒(MSPS))进行采样,以能够对驱动信号进行过采样。在一种形式中,例如ADC电路826、828的采样速度可实现驱动信号的约200x(根据频率而定)的过采样。在某些形式中,可通过令单个ADC电路经由二路式多路复用器接收输入电压和电流信号来执行ADC电路826、828的采样操作。通过在发生器800的形式中使用高速采样,除可实现其他事物之外,还可实现对流过动态支路的复杂电流的计算(这在某些形式中可用于实施上述基于DDS的波形形状控制)、对采样信号进行精确的数字滤波,以及以高精度计算实际功耗。由ADC电路826、828输出的电压和电流反馈数据可由逻辑装置816接收并处理(例如,先进先出(FIFO)缓冲器、多路复用器),并且被存储在数据存储器中,以供由例如DSP处理器822后续检索。如上所述,电压和电流反馈数据可用作算法的输入用于以动态行进方式使LUT波形样本预先失真或修改。在某些形式中,当采集到电压和电流反馈数据对时,可能需要基于由逻辑装置816输出的对应LUT样本或以其他方式与该对应LUT样本相关联,来对每一存储的电压和电流反馈数据对进行编索引。以此方式使LUT样本和电压和电流反馈数据同步有助于预失真算法的准确计时和稳定性。
在某些形式中,可使用电压和电流反馈数据来控制驱动信号的频率和/或振幅(例如,电流振幅)。在一种形式中,例如,可使用电压和电流反馈数据来确定阻抗相位。随后,可控制驱动信号的频率以最小化或减小所确定阻抗相位与阻抗相位设定点(例如,0°)之间的差值,从而最小化或减小谐波畸变的影响,并相应地提高阻抗相位测量精确度。相位阻抗和频率控制信号的确定可在DSP处理器822中实现,例如,其中频率控制信号作为输入被提供至由逻辑装置816实施的DDS控制算法。
在另一形式中,例如可监视电流反馈数据,以便将驱动信号的电流振幅保持在电流振幅设定点。电流振幅设定点可被直接指定或基于特定的电压振幅和功率设定点而间接地确定。在某些形式中,例如可通过DSP处理器822中的控制算法(诸如,例如比例积分微分(PID)控制算法)来实现对电流振幅的控制。由控制算法控制以适当地控制驱动信号的电流振幅的变量可包括:例如,存储在逻辑装置816中的LUT波形样本的标度和/或经由DAC电路834的DAC电路818(其向功率放大器812提供输入)的满标度输出电压。
非隔离台804还可包括第二处理器836以用于除别的之外还提供用户界面(UI)功能。在一种形式中,UI处理器836可包括例如购自Atmel公司(San Jose,California)的具有ARM 926EJ-S核的Atmel AT91SAM9263处理器。UI处理器836所支持的UI功能的示例可包括听觉和视觉用户反馈、与外围装置(例如,经由USB接口)的通信、与脚踏开关的通信、与输入装置(例如,触摸屏显示器)的通信,以及与输出装置(例如,扬声器)的通信。UI处理器836可例如经由SPI总线与DSP处理器822和逻辑装置816通信。尽管UI处理器836可主要支持UI功能,然而在某些形式中,该UI处理器也可与DSP处理器822配合以减缓风险。例如,UI处理器836可被编程用于监测用户输入和/或其他输入(例如,触摸屏输入、脚踏开关输入、温度传感器输入)的各个方面,并且当检测错误状况时停用发生器800的驱动输出。
在某些形式中,例如DSP处理器822与UI处理器836两者可确定并监测发生器800的操作状态。对于DSP处理器822,发生器800的操作状态可指示例如由DSP处理器822实施的是哪些控制和/或诊断过程。对于UI处理器836,发生器800的操作状态可指示例如UI的哪些元素(例如,显示屏、声音)呈现给用户。相应的DSP处理器822和UI处理器836可独立地保持发生器800的当前操作状态并识别和评估该当前操作状态的可能转变。DSP处理器822可用作此关系中的主体并确定何时会发生操作状态间的转变。UI处理器836可注意到操作状态间的有效转变并可确认特定的转变是否适当。例如,当DSP处理器822命令UI处理器836转变至特定状态时,UI处理器836可证实所要求的转变是有效的。如果UI处理器836确定所要求的状态间转变是无效的,则UI处理器836可使发生器800进入故障模式。
非隔离台804还可包括控制器838,以用于监测输入装置(例如,用于接通和断开发生器800的电容触摸传感器、电容触摸屏)。在某些形式中,控制器838可包括至少一个处理器和/或与UI处理器836通信的其他控制器装置。在一种形式中,例如控制器838可包括处理器(例如,可购自Atmel的Meg168 8位控制器),该处理器被配置为监测经由一个或多个电容触摸传感器提供的用户输入。在一种形式中,控制器838可包括触摸屏控制器(例如,可购自Atmel的QT5480触摸屏控制器),以控制和管理从电容触摸屏对触摸数据的采集。
在某些形式中,当发生器800处于“功率关”状态时,控制器838可继续接收操作功率(例如,经由来自发生器800的功率源的线,诸如以下讨论的功率源854)。这样,控制器838可继续监测输入装置(例如,位于发生器800的前面板上的电容式触摸传感器),以用于接通和断开发生器800。当发生器800处于功率关状态时,如果检测用户“接通/断开”输入装置的启动,则控制器838可启动功率源(例如,启用功率源854的一个或多个DC/DC电压转换器856的操作)。控制器838可因此启动用于将发生器800转变至“功率开”状态的序列。相反,当发生器800处于功率开状态时,如果检测“接通/断开”输入装置的启动,则控制器838可启动用于将发生器800转变至功率关状态的序列。在某些形式中,例如,控制器838可向UI处理器836报告“接通/断开”输入装置的启动,该处理器继而实施所需的过程序列以用于将发生器800转变至功率关状态。在此类形式中,控制器838可能不具有在建立起功率开状态之后从发生器800移除功率的独立能力。
在某些形式中,控制器838可使发生器800提供听觉或其他感官反馈,以用于警示用户功率开或功率关序列已启动。可在功率开或功率关序列开始时以及在与序列相关联的其它过程开始之前提供此类警示。
在某些形式中,隔离台802可包括器械接口电路840,例如以在外科器械的控制电路(例如,包括手持件开关的控制电路)与非隔离台804的部件(诸如,例如逻辑装置816、DSP处理器822和/或UI处理器836)之间提供通信接口。器械接口电路840可经由通信连接件(诸如,例如基于IR的通信连接件)与非隔离台804的部件交换信息,该通信连接件在隔离台802与非隔离台804之间保持合适程度的电隔离。例如,可使用由隔离变压器供电的低压降调压器为器械接口电路840供电,该低压降调压器从非隔离台804被驱动。
在一种形式中,器械接口电路840可包括与信号调节电路844通信的逻辑电路842(例如,逻辑电路、可编程逻辑电路、PGA、FPGA、PLD)。信号调节电路844可被配置为从逻辑电路842接收周期性信号(例如,2kHz的方波),以生成具有相同频率的双极性询问信号。例如,可使用由差分放大器馈送的双极电流源生成询问信号。该询问信号可被发送到外科器械控制电路(例如,通过使用将发生器800连接到外科器械的缆线中的导体对)并被监测,以确定控制电路的状态或配置。控制电路可包括多个开关、电阻器和/或二极管,以修改询问信号的一个或多个特性(例如,振幅、整流),使得可基于该一个或多个特性唯一地辨别控制电路的状态或配置。在一种形式中,例如信号调节电路844可包括ADC电路,以用于产生由于询问信号通过控制电路而出现在控制电路输入中的电压信号的样本。随后,逻辑电路842(或非隔离台804的部件)可基于ADC电路样本来确定控制电路的状态或配置。
在一种形式中,器械接口电路840可包括第一数据电路接口846,以实现逻辑电路842(或器械接口电路840的其他元件)与设置于外科器械中的或以其他方式与外科器械相关联的第一数据电路之间的信息交换。在某些方面,例如,第一数据电路可设置于整体地附接到外科器械手持件的缆线中,或设置于用于使特定的外科器械类型或模型与发生器800交接的适配器中。第一数据电路可以任何合适的方式实施且可根据包括例如本文相对于第一数据电路所述的任何合适的协议与发生器通信。在某些形式中,第一数据电路可包括非易失性存储装置,诸如EEPROM装置。在某些形式中,第一数据电路接口846可与逻辑电路842分开实施并且包括合适的电路(例如,离散的逻辑装置、处理器),以实现逻辑电路842与第一数据电路之间的通信。在其他形式中,第一数据电路接口846可与逻辑电路842成一体。
在某些形式中,第一数据电路可存储与其相关联的特定外科器械相关的信息。此类信息可包括例如型号、序列号、其中已使用外科器械的多个操作、和/或任何其它类型的信息。此种信息可被器械接口电路840(例如,通过逻辑电路842)读取、被传输到非隔离台804的部件(例如,至逻辑装置816、DSP处理器822和/或UI处理器836),以经由输出装置呈现给用户并且/或者控制发生器800的功能或操作。另外,任何类型的信息均可经由第一数据电路接口846(例如,使用逻辑电路842)被发送至第一数据电路以存储于其中。此类信息可包括例如其中使用外科器械的操作的更新数目和/或其使用的日期和/或时间。
如前所述,外科器械可从手持件拆卸(例如,多功能外科器械可从手持件拆卸)以促进器械可互换性和/或可任意处置性。在此类情形中,常规发生器的识别所使用特定器械构型和相应地优化控制和诊断过程的能力可受限。然而,从兼容性角度来看,通过对外科器械添加可读数据电路来解决此问题是有问题的。例如,设计外科器械来保持与缺少必备数据读取功能的发生器的向后兼容可能由于例如不同的信号方案、设计复杂性和成本而不切实际。本文所述器械的形式通过使用数据电路来解决这些问题,这些数据电路可经济地实施于现有外科器械中并具有最小的设计变化,以保持外科器械与电流发生器平台的兼容性。
另外,发生器800的形式可实现与基于器械的数据电路的通信。例如,发生器800可被配置成与器械(例如,多功能外科器械)中所包含的第二数据电路通信。在一些形式中,第二数据电路可以类似于本文所述的第一数据电路的方式实施。器械接口电路840可包括用于实现该通信的第二数据电路接口848。在一种形式中,第二数据电路接口848可包括三态数字接口,然而也可使用其他接口。在某些形式中,第二数据电路通常可为用于传输和/或接收数据的任何电路。在一种形式中,例如第二数据电路可存储与相关联的特定外科器械相关的信息。此类信息可包括例如型号、序列号、其中已使用外科器械的多个操作、和/或任何其它类型的信息。
在一些形式中,第二数据电路可存储关于相关联的超声换能器、端部执行器或超声驱动系统的电性能和/或超声性能的信息。例如,第一数据电路可指示老化频率斜率,如本文所述。附加地或另选地,任何类型的信息均可经由第二数据电路接口848(例如,使用逻辑电路842)被发送至第二数据电路以存储于其中。此类信息例如可包括其中使用外科器械的操作的更新数目和/或其使用的日期和/或时间。在某些形式中,第二数据电路可传输由一个或多个传感器(例如,基于器械的温度传感器)采集的数据。在某些形式中,第二数据电路可从发生器800接收数据并基于所接收的数据向用户提供指示(例如,发光二极管指示或其他可视指示)。
在某些形式中,第二数据电路和第二数据电路接口848可被配置为使得可实现逻辑电路842与第二数据电路之间的通信而无需提供用于此目的的附加导体(例如,用于将手持件连接到发生器800的缆线的专用导体)。在一种形式中,例如,可使用实施于现有缆线上的单总线通信方案(诸如用于将询问信号从信号调节电路844发射至手持件中的控制电路的导体中的一者)而将信息发送至第二数据电路并从第二数据电路发送信息。这样,可最小化或减少原本可能必要的外科器械的设计变化或修改。此外,因为在共用物理信道上实施的不同类型的通信可为频带分离的,所以第二数据电路的存在对于不具有必备数据读取功能的发生器而言可为“隐形的”,因此能够实现外科器械的向后兼容性。
在某些形式中,隔离台802可包括至少一个阻挡电容器850-1,该至少一个阻挡电容器连接到驱动信号输出件810b以防止直流电流流向患者。例如,可要求信号阻挡电容器符合医疗规则或标准。尽管相对而言单电容器设计中很少出现错误,然而此类错误可造成不良后果。在一种形式中,可设置有与阻挡电容器850-1串联的第二阻挡电容器850-2,其中例如通过ADC电路852来监测从阻挡电容器850-1、850-2之间的点发生的电流渗漏,以对由泄漏电流感应的电压进行采样。这些样本例如可由逻辑电路842接收。基于渗漏电流的变化(如电压样本所指示),发生器800可以确定阻挡电容器850-1、850-2中的至少一个何时发生故障,从而提供优于具有单个故障点的单电容器设计的有益效果。
在某些形式中,非隔离台804可包括功率源854以用于在适当的电压和电流下递送直流功率。功率源可包括例如400W的功率源以用于递送48V直流的系统电压。功率源854还可包括一个或多个DC/DC电压转换器856,以用于接收功率源的输出,以在发生器800的各种部件所需的电压和电流下产生直流输出。如以上结合控制器838所述,当控制器838检测用户启动“接通/断开”输入装置以启用DC/DC电压转换器856的操作或唤醒DC/DC电压转换器856时,DC/DC电压转换器856中的一个或多个可从控制器838接收输入。
图21示出了发生器900的示例,该发生器是发生器800(图20)的一种形式。发生器900被配置为将多个能量模态递送至外科器械。发生器900提供用于独立地或同时将能量递送至外科器械的RF信号和超声信号。RF信号和超声信号可单独或组合提供,并且可同时提供。如上所述,至少一个发生器输出可通过单个端口递送多种能量模态(例如,超声、双极或单极RF、不可逆和/或可逆电穿孔和/或微波能量等等),并且这些信号可分开或同时被递送到端部执行器以处理组织。
发生器900包括联接到波形发生器904的处理器902。处理器902和波形发生器904被配置为基于存储在联接到处理器902的存储器中的信息来生成各种信号波形,为了本公开清楚起见而未示出该存储器。与波形相关联的数字信息被提供给波形发生器904,该波形发生器904包括一个或多个DAC电路以将数字输入转换成模拟输出。模拟输出被馈送到放大器1106用于信号调节和放大。放大器906的经调节和放大的输出联接到电力变压器908。信号通过电力变压器908联接到患者隔离侧中的次级侧。第一能量模态的第一信号被提供给被标记为ENERGY1和RETURN的端子之间的外科器械。第二能量模态的第二信号联接到电容器910两端并被提供给被标记为ENERGY2和RETURN的端子之间的外科器械。应当理解,可输出超过两种能量模态,并且因此下标“n”可被用来指定可提供多至n个ENERGYn端子,其中n是大于1的正整数。还应当理解,在不脱离本公开的范围的情况下,可提供多至“n”个返回路径RETURNn。
第一电压感测电路912联接被标记为ENERGY1和RETURN路径的端子的两端,以测量两端子间的输出电压。第二电压感测电路924联接被标记为ENERGY2和RETURN路径的端子的两端,以测量两端子间的输出电压。如图所示,电流感测电路914与电力变压器908的次级侧的RETURN支路串联设置,以测量任一能量模态的输出电流。如果为每种能量模态提供不同的返回路径,则应在每个返回支路中提供单独的电流感测电路。第一电压感测电路912和第二电压感测电路924的输出被提供给相应的隔离变压器916、922,并且电流感测电路914的输出被提供给另一隔离变压器918。电力变压器908(非患者隔离侧)的初级侧上的隔离变压器916、928、922的输出被提供给一个或多个ADC电路926。ADC电路926的数字化输出被提供给处理器902用于进一步处理和计算。可采用输出电压和输出电流反馈信息来调整提供给外科器械的输出电压和电流,并且计算输出阻抗等参数。处理器902和患者隔离电路之间的输入/输出通信通过接口电路920提供。传感器也可通过接口920与处理器902电气通信。
在一个方面,阻抗可由处理器902通过将联接在被标记为ENERGY1/RETURN的端子的两端的第一电压感测电路912或联接在被标记为ENERGY2/RETURN的端子的两端的第二电压感测电路924的输出除以与功率变压器908的次级侧的RETURN支路串联设置的电流感测电路914的输出来确定。第一电压感测电路912和第二电压感测电路924的输出被提供给单独的隔离变压器916、922,并且电流感测电路914的输出被提供给另一隔离变压器916。来自ADC电路926的数字化电压和电流感测测量值被提供给处理器902以用于计算阻抗。例如,第一能量模态ENERGY1可以是超声能量,并且第二能量模态ENERGY2可以是RF能量。然而,除了超声和双极或单极RF能量模态之外,其它能量模态还包括不可逆和/或可逆电穿孔和/或微波能量等。而且,虽然图21所示的示例示出了可为两种或更多种能量模态提供单个返回路径RETURN,但在其他方面,可为每种能量模态ENERGYn提供多个返回路径RETURNn。因此,如本文所述,可通过将第一电压感测电路912的输出除以电流感测电路914的输出来测量超声换能器阻抗,并且可通过将第二电压感测电路924的输出除以电流感测电路914的输出来测量组织阻抗。
如图21中所示,包括至少一个输出端口的发生器900可包括具有单个输出和多个分接头的电力变压器908,以例如根据正在执行的组织处理类型以一种或多种能量模态(诸如超声、双极或单极RF、不可逆和/或可逆电穿孔和/或微波能量等等)的形式向端部执行器提供功率。例如,发生器900可用较高电压和较低电流递送能量以驱动超声换能器,用较低电压和较高电流递送能量以驱动RF电极以用于密封组织,或者用凝固波形递送能量以用于使用单极或双极RF电外科电极。来自发生器900的输出波形可被操纵、切换或滤波,以向外科器械的端部执行器提供频率。超声换能器与发生器900输出端的连接将优选地位于被标记为ENERGY1和RETURN的输出端之间,如图21所示。在一个示例中,RF双极电极与发生器900输出端的连接将优选地位于被标记为ENERGY2和RETURN的输出端之间。在单极输出的情况下,优选的连接将是ENERGY2输出端的有源电极(例如,铅笔或其他探头)以及连接至RETURN输出端的合适的返回垫。
附加细节公开于2017年3月30日公布的名称为“TECHNIQUES FOR OPERATINGGENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS ANDSURGICALINSTRUMENTS”的美国专利申请公布2017/0086914中,该专利申请全文以引用方式并入本文。
如本说明书通篇所用,术语“无线”及其衍生物可用于描述可通过使用经调制的电磁辐射通过非固体介质来传送数据的电路、装置、系统、方法、技术、通信信道等。该术语并不意味着相关联的组织不包含任何电线,尽管在一些方面它们可能不包含。通信模块可实现多种无线或有线通信标准或协议中的任一种,包括但不限于Wi-Fi(IEEE802.11系列)、WiMAX(IEEE 802.16系列)、IEEE 802.20、长期演进(LTE)、Ev-DO、HSPA+、HSDPA+、HSUPA+、EDGE、GSM、GPRS、CDMA、TDMA、DECT、蓝牙、及其以太网衍生物、以及被指定为3G、4G、5G和以上的任何其它无线和有线协议。计算模块可包括多个通信模块。例如,第一通信模块可专用于较短距离的无线通信诸如Wi-Fi和蓝牙,并且第二通信模块可专用于较长距离的无线通信诸如GPS、EDGE、GPRS、CDMA、WiMAX、LTE、Ev-DO等。
如本文所用,处理器或处理单元是对一些外部数据源(通常为存储器或一些其它数据流)执行操作的电子电路。本文所用术语是指组合多个专门的“处理器”的一个或多个系统(尤其是片上系统(SoC))中的中央处理器(中央处理单元)。
如本文所用,片上系统或芯片上系统(SoC或SOC)为集成了计算机或其它电子系统的所有器件的集成电路(也被称为“IC”或“芯片”)。它可以包含数字、模拟、混合信号以及通常射频功能—全部在单个基板上。SoC将微控制器(或微处理器)与高级外围装置如图形处理单元(GPU)、Wi-Fi模块或协处理器集成。SoC可以包含或可不包含内置存储器。
如本文所用,微控制器或控制器为将微处理器与外围电路和存储器集成的系统。微控制器(或微控制器单元的MCU)可被实现为单个集成电路上的小型计算机。其可类似于SoC;SoC可包括作为其器件之一的微控制器。微控制器可包含一个或多个核心处理单元(CPU)以及存储器和可编程输入/输出外围装置。以铁电RAM、NOR闪存或OTP ROM形式的程序存储器以及少量RAM也经常包括在芯片上。与个人计算机或由各种分立芯片组成的其它通用应用中使用的微处理器相比,微控制器可用于嵌入式应用。
如本文所用,术语控制器或微控制器可为与外围装置交接的独立式IC或芯片装置。这可为计算机的两个部件或用于管理该装置的操作(以及与该装置的连接)的外部装置上的控制器之间的链路。
如本文所述的处理器或微控制器中的任一者可为任何单核或多核处理器,诸如由德克萨斯器械公司提供的商品名为ARM Cortex的那些。在一个方面,处理器可为例如购自德克萨斯器械公司的LM4F230H5QR ARM Cortex-M4F处理器内核,其包括:256KB的单循环闪存或其他非易失性存储器(最多至40MHZ)的片上存储器、用于使性能改善超过40MHz的预取缓冲器、32KB的单循环串行随机存取存储器(SRAM)、装载有软件的内部只读存储器(ROM)、2KB的电可擦除可编程只读存储器(EEPROM)、一个或多个脉宽调制(PWM)模块、一个或多个正交编码器输入(QEI)模拟、具有12个模拟输入信道的一个或多个12位模数转换器(ADC)、以及易得的其他特征。
在一个示例中,处理器可包括安全控制器,该安全控制器包括两个基于控制器的系列,诸如同样由德克萨斯器械公司提供的商品名为Hercules ARM Cortex R4的TMS570和RM4x。安全控制器可被配置为专门用于IEC 61508和ISO 26262安全关键应用等等,以提供先进的集成安全特征结构,同时递送可定标的性能、连接性和存储器选项。
模块化装置包括可容纳在外科集线器内的模块(如结合图3和图9所述)和外科装置或器械,该外科装置或器械可连接到各种模块以便与对应的外科集线器连接或配对。模块化装置包括例如智能外科器械、医疗成像装置、抽吸/冲洗装置、排烟器、能量发生器、呼吸机、吹气器和显示器。本文所述的模块化装置可通过控制算法来控制。控制算法可在模块化装置自身上、在与特定模块化装置配对的外科集线器上或在模块化装置和外科集线器两者上执行(例如,经由分布式计算架构)。在一些示例中,模块化装置的控制算法基于由模块化装置自身感测到的数据来控制装置(即,通过模块化设备之中、之上或连接到模块化装置的传感器)。该数据可与正在手术的患者(例如,组织性能或吹气压力)或模块化装置本身相关(例如,刀被推进的速率、马达电流或能量水平)。例如,外科缝合和切割器械的控制算法可根据刀在其前进时遇到的阻力来控制器械的马达驱动其刀穿过组织的速率。
云系统硬件和功能模块
图22为根据本公开的至少一个方面的计算机实现的交互式外科系统的框图。在一个方面,计算机实现的交互式外科系统被配置为监测和分析与各种外科系统的操作相关的数据,这些外科系统包括外科集线器、外科器械、机器人装置以及手术室或医疗设施。计算机实现的交互式外科系统包括基于云的分析系统。虽然基于云的分析系统被描述为外科系统,但不一定如此限制,并且其通常可以是基于云的医疗系统。如图22所示,基于云的分析系统包括多个外科器械7012(可与器械112相同或类似)、多个外科集线器7006(可与集线器106相同或类似),以及外科数据网络7001(可与网络201相同或类似),以将外科集线器7006联接到云7004(可与云204相同或类似)。多个外科集线器7006中的每个外科集线器通信地联接到一个或多个外科器械7012。集线器7006还经由网络7001通信地联接到计算机实现的交互式外科系统的云7004。云7004是用于存储、操纵和传送基于各种外科系统的操作生成的数据的远程集中式硬件和软件源。如图22所示,经由网络7001实现对云7004的访问,该网络可以是互联网或一些其他合适的计算机网络。联接到云7004的外科集线器7006可被认为是云计算系统(即,基于云的分析系统)的客户端侧。外科器械7012与外科集线器7006配对,以用于控制和实施如本文所述的各种外科手术或操作。
此外,外科器械7012可包括收发器,以用于将数据传输到这些收发器对应的外科集线器7006(其还可包括收发器)和从这些收发器对应的外科集线器7006传输数据。外科器械7012和对应的集线器7006的组合可指示用于提供医疗操作的特定位置,诸如医疗设施(例如,医院)中的手术室。例如,外科集线器7006的存储器可存储位置数据。如图22所示,云7004包括中央服务器7013(可与远程服务器7013相同或类似)、集线器应用服务器7002、数据分析模块7034和输入/输出(“I/O”)接口7006。云7004的中央服务器7013共同管理云计算系统,该云计算系统包括监测客户端外科集线器7006的请求并管理云7004的处理容量以用于执行请求。中央服务器7013中的每个中央服务器包括联接到合适的存储器装置7010的一个或多个处理器7008,该存储器装置可包括易失性存储器诸如随机存取存储器(RAM)和非易失性存储器诸如磁存储装置。存储器装置7010可包括机器可执行指令,这些机器可执行指令在被执行时使得处理器7008执行数据分析模块7034以用于下文所述的基于云的数据分析、操作、推荐和其他操作。此外,处理器7008可独立地或结合由集线器7006独立地执行的集线器应用程序来执行数据分析模块7034。中央服务器7013还包括可驻留在存储器2210中的汇总医疗数据数据库2212。
基于经由网络7001与各种外科集线器7006的连接,云7004可汇总来自由各种外科器械7012及其对应集线器7006生成的特定数据的数据。此类汇总数据可存储在云7004的汇总医疗数据库7012内。具体地,云7004可有利地对汇总数据执行数据分析和操作,以产生见解和/或执行单个集线器7006自身无法实现的功能。为此,如图22所示,云7004和外科集线器7006通信地联接以传输和接收信息。I/O接口7006经由网络7001连接到多个外科集线器7006。这样,I/O接口7006可被配置为在外科集线器7006和汇总医疗数据数据库7011之间传输信息。因此,I/O接口7006可促进基于云的分析系统的读/写操作。可响应于来自集线器7006的请求来执行此类读/写操作。这些请求可通过集线器应用程序传输到集线器7006。I/O接口7006可包括一个或多个高速数据端口,该一个或多个高速数据端口可包括通用串行总线(USB)端口、IEEE 1394端口,以及用于将云7004连接到集线器7006的Wi-Fi和蓝牙I/O接口。云7004的集线器应用服务器7002被配置为托管由外科集线器7006执行的软件应用(例如,集线器应用)并向其提供共享的能力。例如,集线器应用服务器7002可以管理集线器应用程序通过集线器7006提出的请求、控制对汇总医疗数据数据库7011的访问,以及执行负载平衡。参考图23详细地描述了数据分析模块7034。
本公开中描述的特定云计算系统配置被具体设计成解决在使用医疗装置(诸如外科器械7012、112)执行的医疗操作和手术的背景下产生的各种问题。具体地,外科器械7012可为数字外科装置,该数字外科装置被配置为与云7004进行交互以用于实施改善外科操作的性能的技术。各种外科器械7012和/或外科集线器7006可包括触摸控制的用户界面,使得临床医生可控制外科器械7012和云7004之间的交互的各方面。也可使用用于控制的其他合适的用户界面,诸如听觉控制的用户界面。
图23为根据本公开的至少一个方面的示出计算机实现的交互式外科系统的功能架构的框图。基于云的分析系统包括多个数据分析模块7034,这些数据分析模块可由云7004的处理器7008执行,以用于为医疗领域中具体产生的问题提供数据分析解决方案。如图23所示,基于云的数据分析模块7034的功能可经由由集线器应用服务器7002托管的集线器应用程序7014来辅助,这些集线器应用服务器可在外科集线器7006上访问。云处理器7008和集线器应用程序7014可以结合操作,以执行数据分析模块7034。应用程序接口(API)7016限定对应于集线器应用程序7014的一组协议和例程。另外,API 7016管理向汇总医疗数据库7012中存储和检索数据或从该汇总医疗数据库中存储和检索数据以用于应用程序7014的操作。高速缓存7018也存储数据(例如,暂时地)并且联接到API 7016以更有效地检索由应用程序7014使用的数据。图23中的数据分析模块7034包括资源优化模块7020、数据收集和汇总模块7022、认证和安全模块7024、控制程序更新模块7026、患者结果分析模块7028、推荐模块7030以及数据分类和优先化模块7032。根据一些方面,云7004还可以实现其他合适的数据分析模块。在一个方面,数据分析模块用于基于分析趋势、结果和其他数据的特定推荐。
例如,数据收集和汇总模块7022可用于生成自描述数据(例如,元数据),包括显著特征或配置(例如,趋势)的识别、冗余数据集的管理以及数据在配对数据集中的存储,这些配对数据集可通过外科手术分组,但不一定锁定到实际外科手术日期和外科医生。具体地,由外科器械7012的操作生成的配对数据集可包括应用二进制分类,例如,出血或非出血事件。更一般地,二进制分类可表征为期望的事件(例如,成功的外科手术)或不期望的事件(例如,误击发或误用的外科器械7012)。汇总自描述数据可对应于从外科集线器7006的各种组或子组接收的单个数据。因此,数据收集和汇总模块7022可基于从外科集线器7006接收的原始数据来生成汇总元数据或其他组织数据。为此,处理器7008可以可操作地联接到集线器应用程序7014和汇总医疗数据数据库7011,以用于执行数据分析模块7034。数据收集和汇总模块7022可以将汇总组织数据存储到汇总医疗数据数据库2212中。
资源优化模块7020可以分析该汇总数据以确定用于特定或一组医疗设施的资源的最佳使用。例如,资源优化模块7020可基于此类器械7012的对应预测需求来确定一组医疗设施的外科缝合器械7012的最佳顺序点。资源优化模块7020还可评估各种医疗设施的资源使用或其他操作配置,以确定是否可改善资源使用。类似地,推荐模块7030可以分析来自数据收集和汇总模块7022的汇总组织数据以提供推荐。例如,推荐模块7030可基于例如高于预期的错误率向医疗设施(例如,医疗服务提供方,诸如医院)推荐应将特定外科器械7012升级至改进版本。另外,推荐模块7030和/或资源优化模块7020可推荐更好的供应链参数,诸如产品重新排序点,并且提供不同外科器械7012的建议、其使用或手术步骤以改善外科结果。医疗设施可经由对应的外科集线器7006接收此类推荐。还可提供关于各种外科器械7012的参数或配置的更具体的推荐。集线器7006和/或外科器械7012还可各自具有显示由云7004提供的数据或推荐的显示屏。
患者结果分析模块7028可分析与外科器械7012的当前使用的操作参数相关联的外科结果。患者结果分析模块7028还可以分析和评估其他潜在操作参数。就这一点而言,推荐模块7030可以基于产生更好的外科结果(诸如更好的密封或更少的出血)来推荐使用这些其他潜在操作参数。例如,推荐模块7030可向外科集线器7006传输关于何时针对对应的缝合外科器械7012使用特定仓的推荐。因此,基于云的分析系统在控制公共变量时可被配置为分析大量原始数据的集合并提供对多个医疗设施的集中式推荐(有利地基于汇总数据来确定)。例如,基于云的分析系统可基于医疗实践的类型、患者的类型、患者的数量、医疗提供方之间的地理类似性、医疗提供方/设施使用类似类型的器械等来分析、评估和/或汇总数据,使得任何单个医疗设施都不能独立地分析。控制程序更新模块7026可被配置为在对应的控制程序被更新时执行各种外科器械7012推荐。例如,患者结果分析模块7028可以识别将特定控制参数与成功(或不成功)结果相关联的相关性。当更新的控制程序经由控制程序更新模块7026传输到外科器械7012时,可解决此类相关性。经由对应的集线器7006传输的对器械7012的更新可结合由云7004的数据收集和汇总模块7022采集和分析的汇总性能数据。另外,患者结果分析模块7028和推荐模块7030可基于汇总性能数据来识别使用器械7012的改善的方法。
基于云的分析系统可包括由云7004实现的安全特征。这些安全特征可由认证和安全模块7024管理。每个外科集线器7006可具有相关联的唯一凭证,诸如用户名、密码和其他合适的安全凭证。这些凭证可存储在存储器7010中并且与允许的云访问级别相关联。例如,基于提供准确的凭证,外科集线器7006可被授予访问权限以在预先确定的程度上与云通信(例如,可仅参与传输或接收某些限定类型的信息)。为此,云7004的汇总医疗数据数据库7011可以包括用于验证所提供的凭证的准确性的认证凭证的数据库。不同的凭证可与对与云7004进行交互的不同权限级别相关联,诸如用于接收由云7004生成的数据分析的预先确定的访问级别。此外,出于安全目的,云可以维护集线器7006、器械7012和可包括禁止装置的“黑名单”的其他装置的数据库。具体地,可禁止黑名单上列出的外科集线器7006与云进行交互,同时黑名单上列出的外科器械7012可不具有对于对应的集线器7006的功能访问权限并且/或者可在与其对应的集线器7006配对时被阻止完全起作用。附加地或另选地,云7004可基于不相容性或其他指定标准来标记器械7012。这样,可以识别和解决伪造的医疗装置以及在整个基于云的分析系统中对此类装置的不当重复使用。
外科器械7012可使用无线收发器来传输无线信号,这些无线信号可表示例如用于访问对应集线器7006和云7004的认证凭证。有线收发器也可用于发射信号。此类认证凭证可存储在外科器械7012的相应存储装置中。认证和安全模块7024可确定认证凭证是准确的还是伪造的。认证和安全模块7024还可动态地生成用于增强的安全性的认证凭证。凭证也可被加密,诸如通过使用基于哈希函数的加密。在传输适当认证时,外科器械7012可将信号传输到对应的集线器7006并且最终传输到云7004以指示器械7012准备好获取和传输医疗数据。作为响应,云7004可以转变成能够接收医疗数据以存储到汇总医疗数据数据库7011中的状态。该数据传输准备就绪可例如由器械7012上的光指示器指示。云7004还可将信号传输到外科器械7012以用于更新其相关联的控制程序。云7004可传输涉及特定类别的外科器械7012(例如,电外科器械)的信号,使得控制程序的软件更新仅传输到适当的外科器械7012。此外,云7004可用于实现系统范围内的解决方案,以基于选择性数据传输和认证凭证来解决本地或全球问题。例如,如果一组外科器械7012被识别为具有共同的制造缺陷,则云7004可改变对应于该组的认证凭证以实施该组的可操作闭锁件。
基于云的分析系统可允许监测多个医疗设施(例如,医院之类的医疗设施)以确定改进的实践并相应地推荐改变(例如,经由推荐模块2030)。因此,云7004的处理器7008可分析与单个医疗设施相关联的数据以识别该设施并且将该数据与和组中的其他医疗设施相关联的其他数据汇总。例如,可以基于类似的操作实践或地理位置来限定组。这样,云7004可提供医疗设施组范围的分析和推荐。基于云的分析系统还可用于增强的态势感知。例如,处理器7008可对推荐对特定设施的成本和有效性的影响进行预测建模(相对于总体操作和/或各种医疗手术)。还可将与该特定设施相关联的成本和有效性与其他设施或任何其他类似设施的对应本地区域进行比较。
数据分类和优先化模块7032可以基于关键性(例如,与数据相关联的医疗事件的严重性、出乎意料、怀疑)对数据进行优先化和分类。这种分类和优先化可以与上述其他数据分析模块7034的功能结合使用,以改善本文所述的基于云的分析和操作。例如,数据分类和优先化模块7032可为由数据收集和汇总模块7022以及患者结果分析模块7028执行的数据分析分配优先级。不同的优先级可导致来自云7004的特定响应(对应于紧急性级别),诸如加速响应递增、特殊处理、从汇总医疗数据数据库7011排除或其他合适的响应。此外,如果需要,云7004可通过集线器应用服务器传输来自对应外科器械7012的附加数据的请求(例如,推送消息)。推送消息可导致在对应的集线器7006上显示的用于请求支持或附加数据的通知。在云检测显著的不规则性或异常值并且云不能确定不规则性的原因的情况下,可能需要该推送消息。中央服务器7013可被编程为在某些重要情况下触发该推送消息,例如,诸如当数据被确定为不同于超过预先确定的阈值的预期值时或当其表现出安全性已被包括时。
各种功能的附加示例细节在下文的后续描述中提供。各种描述中的每个可利用如图22和图23所述的云架构作为硬件和软件实现的一个示例。
安全和认证趋势以及反应性措施
在通信地联接到位于不同地理区域中的多个通信和数据收集中心的基于云的医疗系统中,始终存在安全风险。基于云的医疗系统可汇总来自多个通信和数据收集中心的数据,其中由任何数据收集中心收集的数据可源自通信地联接到该数据收集中心的一个或多个医疗装置。可以将未授权的医疗设备诸如假冒的装置、仿制或伪造的装置、或者被盗装置连接到数据收集中心。这些装置可能包含病毒,可能具有错误的校准,缺乏最新的更新设定,或者以其他方式未能通过安全检查,如果在外科手术期间使用这些装置的话,则可能对患者有害。此外,多个数据收集中心可包含多个进入点,诸如多个USB或其他输入端口,或输入用户密码的机会,如果访问不当,则这些进入点可表示可到达基于云的医疗系统、其他数据收集中心和连接的医疗装置的安全漏洞。装置被篡改的风险或者数据被盗或被操纵的风险可导致严重后果,特别是因为整个系统被用于改善医疗护理。
到达基于云的医疗系统的所有面的安全系统可能无效,除非存在集中式部件,该集中式部件被配置为知道所有通信和数据收集中心以及在其中连接的所有装置。如果安全系统仅局限于每个数据收集中心或每个进入点,则来自一个进入点的信息可能不会正确地传播到其他安全点。因此,如果在一个点处发生漏洞,或者如果在一个点处使用不正确的装置,则该信息可能不会正确地传播到其他中心或装置。因此,集中式安全系统或至少被配置为与控制接入点的所有医疗集线器通信的系统将优选地知道可能发生的所有不同问题并且根据需要将那些问题传送到其他端口。
在一些方面,基于云的医疗系统包括安全和认证系统,该安全和认证系统被配置为监测所有通信和数据收集中心,诸如位于手术室中的医疗集线器或塔,以及通信地联接到那些中心的任何智能医疗器械。作为基于云的医疗系统的一部分,基于云的安全和认证系统可被配置为检测对包含在云中的任何集线器系统或其他受保护数据集的未授权或不规则访问。由于基于云的安全系统的集中式性质(在云系统被配置为与系统中的每个集线器通信的意义上),如果在一个集线器处发现任何识别的不规则性,则该安全系统可操作以通过将该信息传送到其他集线器来改善所有其他集线器处的安全性。例如,如果在一家医院中的集线器处使用具有未授权序列号的外科器械,则基于云的安全系统可在位于该医院中的本地集线器处获悉该情况,并且然后将该信息传送到同一医院中的所有其他集线器以及周围区域中的所有医院。
在一些方面,基于云的医疗系统可被配置为监测外科装置并且批准或拒绝对与外科集线器一起使用的每个外科装置的访问。每个外科装置可通过与集线器执行认证协议交换来向集线器注册。基于云的医疗系统可了解所有外科装置和指示外科装置是否可接受的状态,诸如装置是否假冒、是否缺少适当的序列号、是否有故障、是否有病毒等。随后,基于云的医疗系统可被配置为即使外科装置连接到集线器,也能够阻止与外科装置的交互。
这样,基于云的安全系统可为任何特定集线器或医疗设施提供最全面的安全性,因为其能够看到位于其他地方的问题。
图24提供了根据一些方面的云医疗分析系统10000的示例性功能的图示,该云医疗分析系统用于向互连的多个医疗设施提供改善的安全和认证。从框A(参考标号10002)处开始,作为起点,可从一个设施或区域注册可疑活动。可疑活动可以各种形式出现。例如,外科装置可在集线器处被记录为具有重复的序列号或者不被认为在可接受范围内的编号,或者序列号可能已经在不同的位置处被注册。在一些方面,外科装置可具有附加的认证机制,诸如在外科装置和外科集线器(当它们连接时)之间的某类型的电子或数字握手交换。每个装置可被编程为具有数字签名和/或知道如何执行认证过程。外科装置的固件可能需要被适当地编程以知道在该交换期间如何执行。认证握手可周期性地变化,并且可由云周期性地指定。这些中的任一者可在装置与医疗集线器的互连期间失效,从而触发对医疗集线器和云系统10000的警示。
在一些方面,云系统10000可查看由医疗装置提供的触发可疑活动的信息,并且如果该信息明确地有欺诈性或有故障,则可发生装置的警示和拒绝,使得将防止医疗装置与医疗集线器和/或同一设施中的其他医疗集线器一起操作。虽然云系统10000可被配置为防止异常,但是云系统10000也可以能够利用其大量知识来制定附加安全措施,使单个集线器作为入口将不能自己执行。下面进一步描述一个示例。
在框B(参考标号10004)处,可通过至少将外科装置与云网络内的所有已知装置进行比较,将本地医疗集线器处的活动传输到云进行认证。在这种情形下,外科装置可被注册为可疑或具有一些可疑的活动或性能。云可被配置为随后与作为可疑装置来源的本地集线器或设施进行交换反馈循环。云可确定从该设施请求附加数据。此外,医疗设施可经由一个或多个外科集线器从云请求关于一个或多个外科装置的认证或询问数据。在该示例中,位于Texas中的设施中的医疗集线器请求与云系统10000进行针对更多数据的通信交换,以确定在其本地集线器中的一个本地集线器处的可疑活动是否真正有问题。
在框C(参考标号10006)处,云认证和安全系统随后可被配置为执行附加数据分析来确定任何威胁的真实性和该可疑活动的性质的更大背景。在该示例中,基于云的安全系统已执行分析并且发现安全威胁的至少两条证据,这在框C的图表中可视地表示。首先,在比较多个医疗设施的数据请求和医疗询问的数量时,确定位于Texas中的当前请求设施与所有其他设施相比具有数量过多的数据请求或医疗询问。云可被配置为将此标记为需要解决的一个安全问题。其次,与数据请求的数量相比,该Texas设施处的可疑数据点或发现的数量也非常大。这些认识中的一者或两者可以提示云安全系统具体地在该Texas设施处执行不同的安全变更。
因此,在框D(参考标号10008)处,响应于作为整体的Texas中的设施的识别的异常行为,云安全系统可以请求与Texas相关的附加数据以更好地了解实践的性质和潜在威胁。例如,关于购买实践、供应商、所使用的外科器械的类型、所执行的外科手术的类型(与其他设施比较)等的附加数据可从该Texas设施处的一个或多个外科集线器获得,或者可在已经存储在云系统10000中的数据中访问。云安全系统可被配置为寻找附加的异常和模式,这些异常和模式可有助于确定如何变更特定于该Texas设施或一般地Texas区域中的设施的安全手术。
在框E(参考标号10010)处,一旦收集并分析了附加信息,云安全系统就可启动针对具体地从框A触发该分析的Texas设施的变更的安全协议,以及针对指示独特或高于平均威胁的任何外科装置的任何新的安全手术。例如,可以确定特定类型的外科装置(诸如源自特定制造设施或具有一组特定的唯一标识号的装置)可能有故障、被假冒或具有一些其他类型的安全风险。云系统10000可能已经分析了源自Texas区域的可疑数据点,确定是否存在任何共同性或模式,并且基于这些识别的模式发布安全协议的变更。这些装置随后可在所有外科集线器处被锁定而停止使用,即使它们当前未连接到任何外科集线器。关于安全性的其他示例性变更包括修改所收集的数据的类型以更好地了解威胁的类型或威胁的广泛分布。例如,Texas中的可疑活动可表现出尝试登录系统的某种模式或认证签名,并且因此该模式可被列入对Texas中的其他设施和/或对其他设施的需要特别注意的警示。在一些情况下,可疑活动的模式可与另一个指示标识相关联,诸如品牌或制造商、或一系列序列号。云系统可向已知与这些相关指示标识相关联的那些设施(诸如利用具有同一制造商的医疗装置的所有设施)发出警示。
此外,可在本地Texas区域制定增强的认证手术。例如,云安全系统可选择对源自该Texas设施的所有装置执行附加认证协议。在其他设施处这些附加协议可能不存在或不需要,因为基于缺少可疑活动而认为这些其他设施具有较低水平的安全风险。
在一些方面,如先前所提及的,基于云的安全系统还可被配置为防止对任何集线器或云系统本身的不期望的侵入。这意味着可疑医疗装置可能无法访问来自任何医疗集线器的任何数据,并且还可在其连接到医疗集线器的情况下被阻止操作。在利用云系统和多个医疗集线器的医疗系统中,公共协议可要求只有连接到医疗集线器的医疗装置被授权对患者进行操作,并且因此该医疗集线器将具有防止激活装置的能力。对任何故障或欺诈性外科装置的限制可被设计成在外科手术期间保护患者,并且该限制也可用于保护任何外科集线器和云本身。相同的锁定手术可被设计成阻止两种情形的发生。
在一些方面,外科集线器可被配置为将数据传输到云安全系统,该云安全系统更好地表征安全缺陷或侵入的性质。例如,云安全系统可被配置为在存储器中存储入侵尝试的数量、入侵尝试的来源(例如,来自哪个外科集线器或甚至经由外科集线器的哪个端口或连接)以及用于尝试的入侵的方法(如果有的话)(例如,病毒攻击、认证欺骗等)。
在一些方面,云安全系统还可确定外科装置的行为的哪些类型或外科集线器的其他功能与全球平均值相比不规则,还是只是每个机构所特有的。云安全系统可以这种方式更好地识别哪些实践看起来不规则。任何外科集线器或整个设施的数据日志可被记录并安全地存储在云系统中。云安全系统随后可分析尝试的访问请求和动作以确定区域或机构之间的趋势、相似性和差异。云安全系统随后可向机构报告任何不规则性,并标记任何识别的不规则性以用于有关更新的内部调查,从而防止未来发生违反。值得注意的是,本地集线器或具有多个集线器的本地设施可能无法认识到它们的任何认证行为是否不规则,除非将它们与更宽泛的平均值进行比较或与其他设施进行比较。云系统可被配置为识别这些模式,因为它可访问来自这些多个设施的认证数据和手术。
在一些方面,云安全系统可被配置为分析任何当前集线器控制程序版本以及该版本是何时更新的。云安全系统可验证所有更新是正确的,并且确定其来源在哪里。这可以是附加的检查,以确保外科装置的软件和固件系统是适当的并且未被篡改。
在一些方面,云安全系统还可通过一次分析多个设施来确定较大威胁。系统可在聚合来自多个位置的数据之后确定在较广区域内的可疑活动的任何趋势或模式。安全系统随后可立即或几乎实时地变更多个设施上的安全参数。这可用于对同时攻击快速作出反应,并且可使得通过一次收集来自多次攻击的数据以更好地增加寻找攻击模式的机会和速度,由此更容易地解决同时攻击。具有云系统有助于确认攻击或可疑活动是孤立地发生还是某个大计划的一部分。
态势感知
态势感知是外科系统的一些方面根据从数据库和/或器械接收的数据确定或推断与外科手术相关的信息的能力。该信息可包括正在进行的手术的类型、正在手术的组织的类型或作为手术对象的体腔。利用与外科手术相关的背景信息,外科系统可例如改善该外科系统控制连接到其的模块化装置(例如,机器人臂和/或机器人外科工具)的方式,并且在外科手术的过程期间向外科医生提供背景信息或建议。态势感知可被应用于执行和/或改善例如图22至图24所述的任何功能。
现在参见图25,其示出了描绘集线器(例如,诸如外科集线器106或206)的态势感知的时间轴5200。时间轴5200是说明性的外科手术以及外科集线器106、206可以从外科手术中每个步骤从数据源接收的数据导出的背景信息。时间轴5200描绘了护士、外科医生和其它医疗人员在肺段切除手术期间将采取的典型步骤,从建立手术室开始到将患者转移到术后恢复室为止。
态势感知外科集线器106、206在整个外科手术过程中从数据源接收数据,包括每次医疗人员利用与外科集线器106、206配对的模块化装置时生成的数据。外科集线器106、206可从配对的模块化装置和其他数据源接收该数据,并且在接收新数据时不断导出关于正在进行的手术的推论(即,背景信息),诸如在任何给定时间正在执行手术的哪个步骤。外科集线器106、206的态势感知系统能够例如记录与用于生成报告的手术相关的数据,验证医务人员正在采取的步骤,提供可能与特定手术步骤相关的数据或提示(例如,经由显示屏),基于背景调节模块化装置(例如,激活监测器,调节医学成像装置的视场(FOV),或者改变超声外科器械或RF电外科器械的能量水平),以及采取上述任何其它此类动作。
作为该示例性手术中的第一步5202,医院工作人员从医院的EMR数据库中检索患者的EMR。基于EMR中的选择的患者数据,外科集线器106、206确定待执行的手术是胸腔手术。
第二步5204,工作人员扫描用于手术的进入的医疗用品。外科集线器106、206与在各种类型的手术中使用的用品列表交叉引用扫描的用品,并确认供应的混合物对应于胸腔手术。另外,外科集线器106、206还能够确定手术不是楔形手术(因为进入的用品缺乏胸腔楔形手术所需的某些用品,或者在其它方面不对应于胸腔楔形手术)。
第三步5206,医疗人员经由可通信地连接到外科集线器106、206的扫描器来扫描患者频带。然后,外科集线器106、206可基于所扫描的数据来确认患者的身份。
第四步5208,医务工作人员打开辅助设备。所利用的辅助设备可根据外科手术的类型和外科医生待使用的技术而变化,但在此示例性情况下,它们包括排烟器、吹气器和医学成像装置。当激活时,作为其初始化过程的一部分,作为模块化装置的辅助设备可以自动与位于模块化装置特定附近的外科集线器106、206配对。然后,外科集线器106、206可通过检测在该术前阶段或初始化阶段期间与其配对的模块化装置的类型来导出关于外科手术的背景信息。在该具体示例中,外科集线器106、206确定外科手术是基于配对模块化装置的该特定组合的VATS手术。基于来自患者的EMR的数据的组合,手术中使用的医疗用品的列表以及连接到集线器的模块化装置的类型,外科集线器106、206通常可推断外科小组将执行的具体手术。一旦外科集线器106、206知道正在执行什么具体手术,外科集线器106、206便可从存储器或云中检索该手术的步骤,并且然后交叉参照其随后从所连接的数据源(例如,模块化装置和患者监测装置)接收的数据,以推断外科团队正在执行的外科手术的什么步骤。
第五步5210,工作人员成员将EKG电极和其它患者监测装置附接到患者。EKG电极和其它患者监测装置能够与外科集线器106、206配对。当外科集线器106、206开始从患者监测装置接收数据时,外科集线器106、206因此确认患者在手术室中。
第六步5212,医疗人员诱导患者麻醉。外科集线器106、206可基于来自模块化装置和/或患者监测装置的数据(包括例如EKG数据、血压数据、呼吸机数据、或它们的组合)推断患者处于麻醉下。在第六步5212完成时,肺分段切除手术的术前部分完成,并且手术部分开始。
第七步5214,折叠正在操作的患者肺部(同时通气切换到对侧肺)。例如,外科集线器106、206可从呼吸机数据推断出患者的肺已经塌缩。外科集线器106、206可推断手术的手术部分已开始,因为其可将患者的肺部塌缩的检测与手术的预期步骤(可先前访问或检索)进行比较,从而确定使肺塌缩是该特定手术中的第一手术步骤。
第八步5216,插入医疗成像装置(例如,内窥镜),并启动来自医疗成像装置的视频。外科集线器106、206通过其与医疗成像装置的连接来接收医疗成像装置数据(即,视频或图像数据)。在接收医疗成像装置数据之后,外科集线器106、206可确定外科手术的腹腔镜式部分已开始。另外,外科集线器106、206可确定正在执行的特定手术是分段切除术,而不是叶切除术(注意,楔形手术已经基于外科集线器106、206基于在手术的第二步5204处接收的数据而排除)。来自医疗成像装置124(图2)的数据可用于以多种不同的方式确定与正在执行的手术类型相关的背景信息,包括通过确定医疗成像装置相对于患者解剖结构的可视化取向的角度,监测所利用的医疗成像装置的数量(即,被激活并与外科集线器106、206配对),以及监测所利用的可视化装置的类型。例如,一种用于执行VATS肺叶切除术的技术将摄像机放置在隔膜上方的患者胸腔的下前拐角中,而一种用于执行VATS分段切除术的技术将摄像机相对于分段裂缝放置在前肋间位置。例如,使用模式识别或机器学习技术,可对态势感知系统进行训练,以根据患者解剖结构的可视化识别医疗成像装置的定位。作为另一个示例,一种用于执行VATS肺叶切除术的技术利用单个医疗成像装置,而用于执行VATS分段切除术的另一种技术利用多个摄像机。作为另一示例,一种用于执行VATS分段切除术的技术利用红外光源(其可作为可视化系统的一部分可通信地联接到外科集线器)以可视化不用于VATS肺部切除术中的分段裂隙。通过从医疗成像装置跟踪这些数据中的任何或所有,外科集线器106、206因此可确定正在进行的外科手术的具体类型和/或用于特定类型的外科手术的技术。
第九步5218,外科团队开始手术的解剖步骤。外科集线器106、206可推断外科医生正在解剖以调动患者的肺,因为其从RF发生器或超声发生器接收指示正在击发能量器械的数据。外科集线器106、206可将所接收的数据与外科手术的检索步骤交叉,以确定在过程中的该点处(即,在先前讨论的手术步骤完成之后)击发的能量器械对应于解剖步骤。在某些情况下,能量器械可为安装到机器人外科系统的机械臂的能量工具。
第十步5220,外科团队继续进行手术的结扎步骤。外科集线器106、206可推断外科医生正在结扎动脉和静脉,因为其从外科缝合和切割器械接收指示器械正在被击发的数据。与先前步骤相似,外科集线器106、206可通过将来自外科缝合和切割器械的数据的接收与该过程中的检索步骤进行交叉引用来推导该推论。在某些情况下,外科器械可以是安装到机器人外科系统的机器人臂的外科工具。
第十一步5222,执行手术的分段切除术部分。外科集线器106、206可推断外科医生正在基于来自外科缝合和切割器械的数据(包括来自其仓的数据)横切软组织。仓数据可对应于例如由器械击发的钉的大小或类型。由于不同类型的钉用于不同类型的组织,因此仓数据可指示正被缝合和/或横切的组织的类型。在这种情况下,被击发的钉的类型用于软组织(或其它类似的组织类型),这允许外科集线器106、206推断手术的分段切除术部分正在进行。
第十二步5224中,执行节点解剖步骤。外科集线器106、206可基于从发生器接收的指示正在击发RF或超声器械的数据来推断外科团队正在解剖节点并且执行泄漏测试。对于该特定手术,在横切软组织后使用的RF或超声器械对应于节点解剖步骤,该步骤允许外科集线器106、206进行此类推论。应当指出的是,外科医生根据手术中的具体步骤定期在外科缝合/切割器械和外科能量(即,RF或超声)器械之间来回切换,因为不同器械更好地适于特定任务。因此,其中使用缝合/切割器械和外科能量器械的特定序列可指示外科医生正在执行的手术的步骤。此外,在某些情况下,机器人工具可用于外科手术中的一个或多个步骤,并且/或者手持式外科器械可用于外科手术中的一个或多个步骤。(一个或多个)外科医生可例如在机器人工具与手持式外科器械之间交替和/或可同时使用装置。在第十二步5224完成时,切口被闭合并且手术的术后部分开始。
第十三步5226,逆转患者的麻醉。例如,外科集线器106、206可基于例如呼吸机数据(即,患者的呼吸率开始増加)推断出患者正在从麻醉中醒来。
最后,第十四步5228是医疗人员从患者移除各种患者监测装置。因此,当集线器从患者监测装置丢失EKG、BP和其它数据时,外科集线器106、206可推断患者正在被转移到恢复室。如从该示例性手术的描述可以看出,外科集线器106、206可根据从可通信地联接到外科集线器106、206的各种数据源接收的数据来确定或推断给定外科手术的每个步骤何时发生。
态势感知在2017年12月28日提交的名称为“INTERACTIVE SURGICAL PLATFORM”的美国临时专利申请序列号62/611,341中有进一步描述,该专利申请的公开内容全文以引用方式并入本文。在某些情况下,机器人外科系统(包括本文所公开的各种机器人外科系统)的操作可由集线器106、206基于其态势感知和/或来自其器件的反馈和/或基于来自云102的信息来控制。
本文所述主题的各个方面在以下编号的实施例中陈述:
实施例1:一种用于医疗数据网络的基于云的安全系统,所述安全系统包括:至少一个处理器;至少一个存储器,所述至少一个存储器通信地联接到所述处理器;输入/输出接口,所述输入/输出接口被配置用于访问来自多个医疗集线器的数据,所述多个医疗集线器各自通信地联接到至少一个外科器械;以及数据库,所述数据库驻留在所述至少一个存储器中并被配置为存储所述数据;所述至少一个存储器存储指令,所述指令能够由所述至少一个处理器执行以:识别由通信地联接到位于第一医疗设施处的第一医疗集线器的第一医疗器械引起的第一安全威胁;基于所述第一医疗器械和通信地联接到位于第二医疗设施处的第二医疗集线器的第二医疗器械之间的至少一个共同特性来确定在所述第二医疗集线器处存在第二安全威胁;以及向所述第二医疗设施提供关于所述第二安全威胁的警示。
实施例2:根据实施例1所述的基于云的安全系统,其中,识别所述第一安全威胁包括确定所述第一医疗器械的识别参数无效。
实施例3:根据实施例1至2中任一项所述的基于云的安全系统,其中,识别所述第一安全威胁包括检测所述第一医疗器械正在传输病毒。
实施例4:根据实施例1至3中任一项所述的基于云的安全系统,其中,识别所述第一安全威胁包括确定所述第一医疗器械未通过认证协议。
实施例5:根据实施例1至4中任一项所述的基于云的安全系统,其中,所述至少一个处理器被进一步编程为锁定所述第一医疗器械以防止所述第一医疗器械与所述第一医疗设施中的所述第一医疗集线器和每个其他医疗集线器一起操作。
实施例6:根据实施例1至5所述的基于云的安全系统,其中,所述至少一个处理器被进一步配置为:响应于识别所述第一安全威胁来分析与所述第一医疗设施相关联的警示数据;通过将与所述第一医疗设施相关联的所述警示数据与跟其他医疗设施相关联的警示数据进行比较来确定不规则性;以及响应于所确定的不规则性来确定针对所述第一医疗设施的修正的安全手术。
实施例7:根据实施例1至6中任一项所述的基于云的安全系统,其中,所述至少一个共同特性包括第一医疗装置和第二医疗装置之间的共同制造商。
实施例8:根据实施例1至7中任一项所述的基于云的安全系统,其中,所述至少一个共同特性包括在无效范围内的所述第一医疗装置的第一识别参数和所述第二医疗装置的第二识别参数两者。
实施例9:一种医疗数据网络的基于云的安全系统的用于改善所述医疗数据网络的安全和认证的方法,所述医疗数据网络还包括至少一个外科器械和各自通信地联接到所述基于云的安全系统的多个医疗集线器,所述方法包括:由所述基于云的安全系统识别由通信地联接到位于第一医疗设施处的第一医疗集线器的第一医疗器械引起的第一安全威胁;由所述基于云的安全系统基于所述第一医疗器械和通信地联接到位于第二医疗设施处的第二医疗集线器的第二医疗器械之间的至少一个共同特性来确定在所述第二医疗集线器处存在第二安全威胁;以及由所述基于云的安全系统向所述第二医疗设施提供关于所述第二安全威胁的警示。
实施例10:根据实施例9所述的方法,其中,识别所述第一安全威胁包括确定所述第一医疗器械的识别参数无效。
实施例11:根据实施例9至10中任一项所述的方法,其中,识别所述第一安全威胁包括检测所述第一医疗器械正在传输病毒。
实施例12:根据实施例9至11中任一项所述的方法,其中,识别所述第一安全威胁包括确定所述第一医疗器械未通过认证协议。
实施例13:根据实施例9至12中任一项所述的方法,还包括锁定所述第一医疗器械以防止所述第一医疗器械与所述第一医疗设施中的所述第一医疗集线器和每个其他医疗集线器一起操作。
实施例14:根据实施例9至13中任一项所述的方法,还包括:响应于识别所述第一安全威胁来分析与所述第一医疗设施相关联的警示数据;通过将与所述第一医疗设施相关联的所述警示数据与跟其他医疗设施相关联的警示数据进行比较来确定不规则性;以及响应于所确定的不规则性来确定针对所述第一医疗设施的修正的安全手术。
实施例15:根据实施例9至14中任一项所述的方法,其中,所述至少一个共同特性包括第一医疗装置和第二医疗装置之间的共同制造商。
实施例16:根据实施例9至15中任一项所述的方法,其中,所述至少一个共同特性包括在无效范围内的所述第一医疗装置的第一识别参数和所述第二医疗装置的第二识别参数两者。
实施例17:一种非暂态计算机可读介质,包括指令,所述指令在由医疗数据网络的基于云的安全系统的处理器执行时,使所述处理器执行包括以下各项的操作:识别由通信地联接到位于第一医疗设施处的第一医疗集线器的第一医疗器械引起的第一安全威胁;基于所述第一医疗器械和通信地联接到位于第二医疗设施处的第二医疗集线器的第二医疗器械之间的至少一个共同特性来确定在所述第二医疗集线器处存在第二安全威胁;以及向所述第二医疗设施提供关于所述第二安全威胁的警示。
实施例18:根据实施例17所述的非暂态计算机可读介质,其中识别所述第一安全威胁包括:确定所述第一医疗器械的识别参数无效,检测所述第一医疗器械正在传输病毒,或者确定所述第一医疗器械未通过认证协议。
实施例19:根据实施例17至18中任一项所述的非暂态计算机可读介质,其中所述操作还包括锁定所述第一医疗器械以防止所述第一医疗器械与所述第一医疗设施中的所述第一医疗集线器和每个其他医疗集线器一起操作。
实施例20:根据实施例17至19中任一项所述的非暂态计算机可读介质,其中所述操作还包括:响应于识别所述第一安全威胁来分析与所述第一医疗设施相关联的警示数据;通过将与所述第一医疗设施相关联的所述警示数据与跟其他医疗设施相关联的警示数据进行比较来确定不规则性;以及响应于所确定的不规则性来确定针对所述第一医疗设施的修正的安全手术。
尽管已举例说明和描述了多个形式,但是申请人的意图并非将所附权利要求的范围约束或限制在此类细节中。在不脱离本公开的范围的情况下,可实现对这些形式的许多修改、变化、改变、替换、组合和等同物,并且本领域技术人员将想到这些形式的许多修改、变化、改变、替换、组合和等同物。此外,另选地,可将与所描述的形式相关联的每个元件的结构描述为用于提供由所述元件执行的功能的器件。另外,在公开了用于某些部件的材料的情况下,也可使用其他材料。因此,应当理解,上述具体实施方式和所附权利要求旨在涵盖属于本发明所公开的形式范围内的所有此类修改形式、组合和变型形式。所附权利要求旨在涵盖所有此类修改、变化、改变、替换、修改和等同物。
上述具体实施方式已通过使用框图、流程图和/或示例阐述了装置和/或方法的各种形式。只要此类框图、流程图和/或示例包含一个或多个功能和/或操作,本领域的技术人员就要将其理解为此类框图、流程图和/或示例中的每个功能和/或操作都可以单独和/或共同地通过多种硬件、软件、固件或实际上它们的任何组合来实施。本领域的技术人员将会认识到,本文公开的形式中的一些方面可作为在一台或多台计算机上运行的一个或多个计算机程序(如,作为在一个或多个计算机系统上运行的一个或多个程序),作为在一个或多个处理器上运行的一个或多个程序(如,作为在一个或多个微处理器上运行的一个或多个程序),作为固件,或作为实际上它们的任何组合全部或部分地在集成电路中等效地实现,并且根据本发明,设计电子电路和/或编写软件和/或硬件的代码将在本领域技术人员的技术范围内。另外,本领域的技术人员将会认识到,本文所述主题的机制能够作为多种形式的一个或多个程序产品进行分布,并且本文所述主题的示例性形式适用,而不管用于实际进行分布的信号承载介质的具体类型是什么。
用于编程逻辑以执行各种所公开的方面的指令可存储在系统内的存储器内,诸如动态随机存取存储器(DRAM)、高速缓存、闪存存储器或其它存储器。此外,指令可经由网络或通过其它计算机可读介质来分发。因此,机器可读介质可包括用于存储或发射以机器(例如,计算机)读形式的信息的机构,但不限于软盘、光学盘、光盘、只读存储器(CD-ROM)、磁光盘、只读存储器(ROM)、随机存取存储器(RAM)、可擦除可编程只读存储器(EPROM)、电可擦除可编程只读存储器(EEPROM)、磁卡或光卡、闪存存储器、或经由电信号、光学信号、声学信号或其它形式的传播信号(例如,载波、红外信号、数字信号等)在因特网上发射信息时使用的有形的、机器可读存储装置。因此,非暂态计算机可读介质包括适于以机器(例如,计算机)可读的形式存储或发射电子指令或信息的任何类型的有形机器可读介质。
如本文任一方面所用,术语“控制电路”可指例如硬连线电路系统、可编程电路系统(例如,计算机处理器,该计算机处理器包括一个或多个单独指令处理内核、处理单元,处理器、微控制器、微控制器单元、控制器、数字信号处理器(DSP)、可编程逻辑装置(PLD)、可编程逻辑阵列(PLA)、场可编程门阵列(FPGA))、状态机电路系统、存储由可编程电路系统执行的指令的固件、以及它们的任何组合。控制电路可以集体地或单独地实现为形成更大系统的一部分的电路系统,例如集成电路(IC)、专用集成电路(ASIC)、片上系统(SoC)、台式计算机、膝上型计算机、平板计算机、服务器、智能电话等。因此,如本文所用,“控制电路”包括但不限于具有至少一个离散电路的电子电路、具有至少一个集成电路的电子电路、具有至少一个专用集成电路的电子电路、形成由计算机程序配置的通用计算设备的电子电路(如,至少部分地实施本文所述的方法和/或设备的由计算机程序配置的通用计算机,或至少部分地实施本文所述的方法和/或设备的由计算机程序配置的微处理器)、形成存储器设备(如,形成随机存取存储器)的电子电路,和/或形成通信设备(如,调节解调器、通信开关或光电设备)的电子电路。本领域的技术人员将会认识到,可以模拟或数字方式或它们的一些组合实施本文所述的主题。
如本文的任何方面所用,术语“逻辑”可指被配置为执行前述操作中的任一者的应用程序、软件、固件和/或电路系统。软件可体现为记录在非暂态计算机可读存储介质上的软件包、代码、指令、指令集和/或数据。固件可以体现为在存储器设备中硬编码(例如,非易失性)的代码、指令或指令集和/或数据。
如本文任一方面所用,术语“器件”、“系统”、“模块”等可指计算机相关实体、硬件、硬件和软件的组合、软件或执行中的软件。
如本文任一方面中所用,“算法”是指导致所需结果的有条理的步骤序列,其中“步骤”是指物理量和/或逻辑状态的操纵,物理量和/或逻辑状态可以(但不一定)采用能被存储、转移、组合、比较和以其它方式操纵的电或磁信号的形式。常用于指这些信号,如位、值、元素、符号、字符、术语、数字等。这些和类似的术语可与适当的物理量相关联并且仅仅是应用于这些量和/或状态的方便的标签。
网络可包括分组交换网络。通信装置可能够使用所选择的分组交换网络通信协议来彼此通信。一个示例性通信协议可包括可允许使用传输控制协议/因特网协议(TCP/IP)进行通信的以太网通信协议。以太网协议可符合或兼容电气和电子工程师学会(IEEE)于2008年12月发布的名为“IEEE 802.3标准”的以太网标准和/或本标准的更高版本。另选地或附加地,通信装置可以能够使用X.25通信协议彼此通信。X.25通信协议可符合或符合国际电信联盟电信标准化部门(ITU-T)颁布的标准。另选地或附加地,通信装置可能够使用帧中继通信协议彼此通信。帧中继通信协议可符合或符合国际电话和电话协商委员会(CCITT)和/或美国国家标准学会(ANSI)发布的标准。另选地或附加地,收发器可能够使用异步传输模式(ATM)通信协议彼此通信。ATM通信协议可符合或兼容ATM论坛于2001年8月发布的名为“ATM-MPLS网络互通2.0”的ATM标准和/或该标准的更高版本。当然,本文同样设想了不同的和/或之后开发的连接取向的网络通信协议。
除非上述公开中另外明确指明,否则可以理解的是,在上述公开中,使用术语如“处理”、“计算”、“运算”、“确定”、“显示”的讨论是指计算机系统或类似的电子计算设备的动作和进程,其操纵表示为计算机系统的寄存器和存储器内的物理(电子)量的数据并将其转换成相似地表示为计算机系统存储器或寄存器或其他此类信息存储、传输或显示设备内的物理量的其他数据。
一个或多个部件在本文中可被称为“被配置为”、“可被配置为”、“可操作/可操作地”、“适于/可适于”、“能够”、“可适形/适形于”等。本领域的技术人员将会认识到,除非上下文另有所指,否则“被配置为”通常可涵盖活动状态的部件和/或未活动状态的部件和/或待机状态的部件。
术语“近侧”和“远侧”在本文中是相对于操纵外科器械的柄部部分的临床医生来使用的。术语“近侧”是指最靠近临床医生的部分,术语“远侧”是指远离临床医生定位的部分。还应当理解,为简洁和清楚起见,本文可结合附图使用诸如“竖直”、“水平”、“上”和“下”等空间术语。然而,外科器械在许多方向和位置中使用,并且这些术语并非限制性的和/或绝对的。
本领域的技术人员将认识到,一般而言,本文、以及特别是所附权利要求(例如,所附权利要求的正文)中所使用的术语通常旨在为“开放”术语(例如,术语“包括”应解释为“包括但不限于”,术语“具有”应解释为“至少具有”,术语“包含”应解释为“包含但不限于”等)。本领域的技术人员还应当理解,如果所引入权利要求叙述的具体数目为预期的,则这样的意图将在权利要求中明确叙述,并且在不存在这样的叙述的情况下,不存在这样的意图。例如,为有助于理解,下述所附权利要求可含有对介绍性短语“至少一个”和“一个或多个”的使用以引入权利要求。然而,对此类短语的使用不应视为暗示通过不定冠词“一个”或“一种”引入权利要求表述将含有此类引入权利要求表述的任何特定权利要求限制在含有仅一个这样的表述的权利要求中,甚至当同一权利要求包括介绍性短语“一个或多个”或“至少一个”和诸如“一个”或“一种”(例如,“一个”和/或“一种”通常应解释为意指“至少一个”或“一个或多个”)的不定冠词时;这也适用于对用于引入权利要求表述的定冠词的使用。
另外,即使明确叙述引入权利要求叙述的特定数目,本领域的技术人员应当认识到,此种叙述通常应解释为意指至少所叙述的数目(例如,在没有其它修饰语的情况下,对“两个叙述”的裸叙述通常意指至少两个叙述、或两个或更多个叙述)。此外,在其中使用类似于“A、B和C中的至少一者等”的惯例的那些情况下,一般而言,这种结构意在具有本领域的技术人员将理解所述惯例的意义(例如,“具有A、B和C中的至少一者的系统”将包括但不限于具有仅A、仅B、仅C、A和B一起、A和C一起、B和C一起和/或A、B和C一起等的系统)。在其中使用类似于“A、B或C中的至少一者等”的惯例的那些情况下,一般而言,这种结构意在具有本领域的技术人员将理解所述惯例的意义(例如,“具有A、B或C中的至少一者的系统”应当包括但不限于具有仅A、仅B、仅C、A和B一起、A和C一起、B和C一起和/或A、B和C一起等的系统)。本领域的技术人员还应当理解,通常,除非上下文另有指示,否则无论在具体实施方式、权利要求或附图中呈现两个或更多个替代术语的转折性词语和/或短语应理解为涵盖包括所述术语中的一者、所述术语中的任一个或这两个术语的可能性。例如,短语“A或B”通常将被理解为包括“A”或“B”或“A和B”的可能性。
对于所附的权利要求,本领域的技术人员将会理解,其中表述的操作通常可以任何顺序进行。另外,尽管以(一个或多个)序列出了多个操作流程图,但应当理解,可以不同于所示顺序的其它顺序进行所述多个操作,或者可以同时进行所述多个操作。除非上下文另有规定,否则此类替代排序的示例可包括重叠、交错、中断、重新排序、增量、预备、补充、同时、反向,或其他改变的排序。此外,除非上下文另有规定,否则像“响应于”、“相关”这样的术语或其它过去式的形容词通常不旨在排除此类变体。
值得一提的是,任何对“一个方面”、“一方面”、“一范例”、“一个范例”的提及均意指结合所述方面所述的具体特征、结构或特性包括在至少一个方面中。因此,在整个说明书的不同位置出现的短语“在一个方面”、“在一方面”、“在一范例”、“在一个范例”不一定都指同一方面。此外,具体特征、结构或特性可在一个或多个方面中以任何合适的方式组合。
本说明书提及和/或在任何申请数据表中列出的任何专利申请,专利,非专利公布或其它公开材料均以引用方式并入本文,只要所并入的材料在此不一致。因此,并且在必要的程度下,本文明确列出的公开内容代替以引用方式并入本文的任何冲突材料。据称以引用方式并入本文但与本文列出的现有定义、陈述或其他公开材料相冲突的任何材料或其部分,将仅在所并入的材料与现有的公开材料之间不产生冲突的程度下并入。
概括地说,已经描述了由采用本文所述的概念产生的许多有益效果。为了举例说明和描述的目的,已经提供了一个或多个形式的上述具体实施方式。这些具体实施方式并非意图为详尽的或限定到本发明所公开的精确形式。可以按照上述教导内容对本发明进行修改或变型。选择和描述的一个或多个形式是为了说明原理和实际应用,从而使本领域的普通技术人员能够利用适用于预期的特定用途的所述多个形式和多种修改形式。与此一同提交的权利要求书旨在限定完整范围。
Claims (20)
1.一种用于医疗数据网络的基于云的安全系统,所述安全系统包括:
至少一个处理器;
至少一个存储器,所述至少一个存储器通信地联接到所述处理器;
输入/输出接口,所述输入/输出接口被配置用于访问来自多个医疗集线器的数据,所述多个医疗集线器各自通信地联接到至少一个外科器械;以及
数据库,所述数据库驻留在所述至少一个存储器中并被配置为存储所述数据;
所述至少一个存储器存储指令,所述指令能够由所述至少一个处理器执行以:
识别由通信地联接到位于第一医疗设施处的第一医疗集线器的第一医疗器械引起的第一安全威胁;
基于所述第一医疗器械和通信地联接到位于第二医疗设施处的第二医疗集线器的第二医疗器械之间的至少一个共同特性来确定在所述第二医疗集线器处存在第二安全威胁;以及
向所述第二医疗设施提供关于所述第二安全威胁的警示。
2.根据权利要求1所述的基于云的安全系统,其中,识别所述第一安全威胁包括确定所述第一医疗器械的识别参数无效。
3.根据权利要求1所述的基于云的安全系统,其中,识别所述第一安全威胁包括检测所述第一医疗器械正在传输病毒。
4.根据权利要求1所述的基于云的安全系统,其中,识别所述第一安全威胁包括确定所述第一医疗器械未通过认证协议。
5.根据权利要求1所述的基于云的安全系统,其中,所述至少一个处理器被进一步编程为锁定所述第一医疗器械以防止所述第一医疗器械与所述第一医疗设施中的所述第一医疗集线器和每个其他医疗集线器一起操作。
6.根据权利要求1所述的基于云的安全系统,其中,所述至少一个处理器被进一步配置为:
响应于识别所述第一安全威胁来分析与所述第一医疗设施相关联的警示数据;
通过将与所述第一医疗设施相关联的所述警示数据与跟其他医疗设施相关联的警示数据进行比较来确定不规则性;以及
响应于所确定的不规则性来确定针对所述第一医疗设施的修正的安全手术。
7.根据权利要求1所述的基于云的安全系统,其中,所述至少一个共同特性包括第一医疗装置和第二医疗装置之间的共同制造商。
8.根据权利要求1所述的基于云的安全系统,其中,所述至少一个共同特性包括在无效范围内的所述第一医疗装置的第一识别参数和所述第二医疗装置的第二识别参数两者。
9.一种医疗数据网络的基于云的安全系统的用于改善所述医疗数据网络的安全和认证的方法,所述医疗数据网络还包括至少一个外科器械和各自通信地联接到所述基于云的安全系统的多个医疗集线器,所述方法包括:
由所述基于云的安全系统识别由通信地联接到位于第一医疗设施处的第一医疗集线器的第一医疗器械引起的第一安全威胁;
由所述基于云的安全系统基于所述第一医疗器械和通信地联接到位于第二医疗设施处的第二医疗集线器的第二医疗器械之间的至少一个共同特性来确定在所述第二医疗集线器处存在第二安全威胁;以及
由所述基于云的安全系统向所述第二医疗设施提供关于所述第二安全威胁的警示。
10.根据权利要求9所述的方法,其中,识别所述第一安全威胁包括确定所述第一医疗器械的识别参数无效。
11.根据权利要求9所述的方法,其中,识别所述第一安全威胁包括检测所述第一医疗器械正在传输病毒。
12.根据权利要求9所述的方法,其中,识别所述第一安全威胁包括确定所述第一医疗器械未通过认证协议。
13.根据权利要求9所述的方法,还包括锁定所述第一医疗器械以防止所述第一医疗器械与所述第一医疗设施中的所述第一医疗集线器和每个其他医疗集线器一起操作。
14.根据权利要求9所述的方法,还包括:
响应于识别所述第一安全威胁来分析与所述第一医疗设施相关联的警示数据;
通过将与所述第一医疗设施相关联的所述警示数据与跟其他医疗设施相关联的警示数据进行比较来确定不规则性;以及
响应于所确定的不规则性来确定针对所述第一医疗设施的修正的安全手术。
15.根据权利要求9所述的方法,其中,所述至少一个共同特性包括第一医疗装置和第二医疗装置之间的共同制造商。
16.根据权利要求9所述的方法,其中,所述至少一个共同特性包括在无效范围内的所述第一医疗装置的第一识别参数和所述第二医疗装置的第二识别参数两者。
17.一种非暂态计算机可读介质,所述非暂态计算机可读介质包括指令,所述指令在由医疗数据网络的基于云的安全系统的处理器执行时,使所述处理器执行包括以下各项的操作:
识别由通信地联接到位于第一医疗设施处的第一医疗集线器的第一医疗器械引起的第一安全威胁;
基于所述第一医疗器械和通信地联接到位于第二医疗设施处的第二医疗集线器的第二医疗器械之间的至少一个共同特性来确定在所述第二医疗集线器处存在第二安全威胁;以及
向所述第二医疗设施提供关于所述第二安全威胁的警示。
18.根据权利要求17所述的非暂态计算机可读介质,其中,识别所述第一安全威胁包括:确定所述第一医疗器械的识别参数无效,检测所述第一医疗器械正在传输病毒,或者确定所述第一医疗器械未通过认证协议。
19.根据权利要求17所述的非暂态计算机可读介质,其中所述操作还包括锁定所述第一医疗器械以防止所述第一医疗器械与所述第一医疗设施中的所述第一医疗集线器和每个其他医疗集线器一起操作。
20.根据权利要求17所述的非暂态计算机可读介质,其中,所述操作还包括:
响应于识别所述第一安全威胁来分析与所述第一医疗设施相关联的警示数据;
通过将与所述第一医疗设施相关联的所述警示数据与跟其他医疗设施相关联的警示数据进行比较来确定不规则性;以及
响应于所确定的不规则性来确定针对所述第一医疗设施的修正的安全手术。
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