CN114126502B - 用于外科缝合系统的可替换部件的包装 - Google Patents
用于外科缝合系统的可替换部件的包装 Download PDFInfo
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- CN114126502B CN114126502B CN202080047390.1A CN202080047390A CN114126502B CN 114126502 B CN114126502 B CN 114126502B CN 202080047390 A CN202080047390 A CN 202080047390A CN 114126502 B CN114126502 B CN 114126502B
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Abstract
本发明公开了一种用于与外科器械一起使用的可替换钉仓。所述可替换钉仓在附接到所述外科器械之前储存在包装中。所述包装包括第一层、第二层和RFID系统。所述第一层和所述第二层在所述可替换钉仓周围形成密封件。所述RFID系统包括RFID标签和绝缘体。所述RFID标签包括集成电池、标签天线和包括已存储信息的RFID芯片。所述绝缘体将所述集成电池与所述RFID芯片解除电联接。所述绝缘体被构造成能够当所述密封件在所述第一层与所述第二层之间断开时从所述集成电池分离。在所述绝缘体与所述集成电池分离时,所述RFID标签激活并且将所述已存储信息传输到所述外科器械的RFID扫描器。
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2019年6月28日提交的名称为“SURGICAL SYSTEMS WITH MULTIPLE RFID TAGS”的美国临时专利申请62/868,457的优先权,该临时专利申请的全部公开内容据此以引用方式并入本文。
背景技术
本发明涉及外科器械,并且在各种实施方案中,涉及被设计成用于切割和缝合组织的外科切割和缝合器械及其钉仓。在各种实施方案中,RFID技术可用于识别外科器械的部件,诸如例如钉仓。使用RFID技术的外科系统的示例可见于2011年6月14日公布的名称为“ELECTRICALLY SELF-POWERED SURGICAL INSTRUMENT WITH MANUAL RELEASE”的美国专利7,959,050和2015年2月26日公布的名称为“ERROR DETECTION ARRANGEMENTS FORSURGICAL INSTRUMENT ASSEMBLIES”的美国专利申请2015/0053743,这两个专利全文以引用方式并入本文。
附图说明
通过结合附图来参考本发明实施方案的以下说明,本发明的特征和优点以及实现这些特征和优点的方式将会变得更加明显,并且可更好地理解发明本身,其中:
图1是包括柄部、轴和能够关节运动的端部执行器的外科器械的透视图;
图2为图1的外科器械的正视图;
图3是图1的外科器械的平面图;
图4是图1的外科器械的端部执行器和轴的剖视图;
图5是可旋转连接图1的轴和端部执行器的关节运动接头的细部图,其示出处于中间或居中位置的端部执行器;
图6是图1的外科器械的处于中间或居中位置的关节运动控件的剖视图;
图7是图1的外科器械的端部执行器、细长轴和关节运动接头的分解图;
图8是图1的外科器械的端部执行器、细长轴和关节运动接头的剖视图;
图9是图1的外科器械的端部执行器、细长轴和关节运动接头的透视图;
图10示出了图1的外科器械的端部执行器围绕关节运动接头进行关节运动;
图11是进行关节运动以移动如图12所示的端部执行器的图6的关节运动控件的剖视图;
图12是包括柄部、轴和能够关节运动的端部执行器的外科器械的透视图;
图13是图12的外科器械的侧视图;
图14是位于图12的柄部内的击发构件和小齿轮的透视图;
图15是图14的击发构件和小齿轮和与小齿轮可操作地接合的齿轮减速器组件的透视图;
图16是图12的柄部的透视图,其部分被移除以示出图14的击发构件和小齿轮、图15的齿轮减速器组件,和电动马达,该电动马达被构造成能够根据电动马达转动的方向向远侧和/或向近侧驱动击发构件;
图17是包括柄部、轴、端部执行器和关节运动接头的外科器械的透视图,该关节运动接头将端部执行器连接到轴,其中出于说明的目的示出了柄部的部分被移除;
图18是图17的外科器械的剖视图;
图19是图17的外科器械的分解图;
图20是图17的外科器械的剖视细部图,示出了处于打开构型的端部执行器、处于解锁构型的关节运动接头,和该外科器械柄部的被示出为处于解锁构型的关节运动锁致动器;
图21是图17的外科器械的剖视细部图,示出了处于经关节运动的打开构型的端部执行器、处于解锁构型的关节运动接头,和与图17的外科器械的击发构件接合的关节运动驱动器,其中击发构件的移动可以促动关节运动驱动器并且使端部执行器进行关节运动;
图22是图17的外科器械的剖视细部图,示出了处于闭合构型的端部执行器、处于解锁构型的关节运动接头,和被致动以闭合端部执行器并且将关节运动锁致动器移动到锁定构型的端部执行器闭合驱动装置;
图22A是被示出为处于参照图22描述的构型的图17的外科器械的柄部的剖视细部图;
图23是图17的外科器械的剖视细部图,示出了处于闭合构型的端部执行器和处于锁定构型的关节运动接头,其中已致动的闭合驱动装置防止关节运动锁致动器移动到图20至图22所示的解锁构型;
图24A是被示出为处于锁定构型的图17的外科器械的关节运动接头的平面图;
图24B是被示出为处于解锁构型的图17的外科器械的关节运动接头的平面图;
图25是图17的外科器械的柄部的剖视细部图,示出了由闭合驱动装置与击发构件断开连接的关节运动驱动器;
图26是图17的外科器械的剖视细部图,示出了处于至少部分击发位置的击发构件和由闭合驱动装置与击发构件断开连接的关节运动驱动器;
图27是图17的外科器械的剖视细部图,示出了处于闭合构型的端部执行器,处于锁定构型的关节运动接头和关节运动接头致动器,和处于回缩位置的击发构件;
图28是图17的外科器械的剖视细部图,示出了处于打开构型的端部执行器,处于回缩位置的端部执行器闭合驱动,和处于锁定构型的关节运动接头;
图29是图17的外科器械的剖视细部图,示出了处于打开构型的端部执行器,和处于解锁构型的关节运动接头和关节运动接头致动器,其中关节运动驱动器可以重新连接到击发驱动装置并且用于使端部执行器进行关节运动;
图30是包括另选关节运动锁布置的外科器械的轴和端部执行器的分解视图;
图31是图30的外科器械的端部执行器和轴的剖视正视图,示出端部执行器处于解锁构型;
图32是图30的外科器械的端部执行器和轴的剖视正视图,示出端部执行器处于锁定构型;
图33是包括外科器械和多个可互换轴组件的外科系统的一种形式的组装视图;
图34是联接到可互换轴组件的外科器械柄部的透视图;
图35是图34的外科器械柄部的分解透视图;
图36是图35的柄部的侧正视图,其中移除了柄部外壳的一部分;
图37是可互换轴组件的分解透视图;
图38是图34的柄部和可互换轴组件的一部分的侧正组装视图,示出了这些组件在联接在一起之前的对准,并且为清楚起见省略了其部分;
图39是在附接到外科器械的柄部之前可互换轴组件的一部分的透视图;
图40是联接到柄部的可互换轴组件的一部分的侧视图,其中锁定轭处于与柄部的框架附接模块的一部分的锁定或接合位置;
图41是图40的可互换轴组件和柄部的另一侧视图,其中锁定轭处于脱离或解锁位置;
图42是在联接在一起之前可互换轴组件和柄部的一部分的顶视图;
图43是联接在一起的图42的可互换轴组件和柄部的另一顶视图;
图44是在联接在一起之前与外科器械柄部对准的可互换轴组件的侧正视图;
图45是图44的可互换轴组件和外科器械的前透视图,其中为清楚起见省略了其部分;
图46是在联接在一起之前与外科器械柄部的一部分对准的可互换轴组件的一部分的侧视图,并且为清楚起见省略了其部分;
图47是图46的可互换轴组件和柄部的另一侧正视图,其中轴组件与柄部部分联接接合;
图48是图46和图47的可互换轴组件和柄部在联接在一起之后的另一侧正视图;
图49是在开始联接过程之前与柄部的一部分对准的可互换轴组件的一部分的另一侧正视图;
图50示出了补偿柔性刀带中在横断面长度上的展开效应的方法的逻辑图的一个实施方案;
图51是当轴组件未联接到外科器械柄部的电连接器时用于使该电连接器掉电的系统的示意图;
图52是用于控制本文所公开的外科器械的马达的速度和/或可驱动构件的速度的系统的示意图;
图53是示出用于控制本文所公开的外科器械的马达的速度和/或可驱动构件的速度的另一个系统的示意图;
图54是示出根据本公开的各种实施方案的用于控制本文所述的各种外科器械的各种操作的控制系统的示意图;
图54A是图54的示意图的局部视图;
图54B是图54的示意图的局部视图;
图55是示出根据本公开各种实施方案的用于控制系统的切换电路的示意图;
图56是示出根据本公开各种实施方案的用于控制系统的切换电路的示意图;
图57是示出根据本公开的各种实施方案的用于控制本文所述的各种外科器械的各种操作的控制系统的示意图;
图57A是图57的示意图的局部视图;
图57B是图57的示意图的局部视图;
图58是示出根据本公开的各种实施方案的用于控制本文所述的各种外科器械的各种操作的控制系统的示意图;
图59是示出根据本公开的各种实施方案的图58的横切操作的各种子操作的示意图;
图60是示出根据本公开的各种实施方案的图59的在硬障碍物附近击发操作的各种子操作的示意图;
图61是根据至少一个实施方案的包括柄部、轴和能够关节运动的端部执行器的外科器械的正视图;
图62是根据至少一个实施方案的钉仓的顶视图;
图63示出了根据至少一个实施方案的可以为钉仓诸如图62的钉仓生成的序列号的结构;
图64是图62的钉仓的正视图;
图65是图62的钉仓的平面图;
图66是被构造成能够接收图62的钉仓的钳口的剖视平面图;
图67是根据至少一个实施方案的RFID标签的透视图;
图68是图62的钉仓的仓体的局部剖视图;
图69是图62的钉仓的滑动件的剖视图;
图70是图62的钉仓的可移除盖的透视图;
图71是根据至少一个实施方案的滑动件的剖视图;
图72是根据至少一个实施方案的包括图70的滑动件的端部执行器的正视图;
图72A是图72的端部执行器的正视图,示出了图70的滑动件在钉击发行程期间向远侧推进;
图72B是图72的端部执行器的正视图,示出了在钉击发行程结束时图70的滑动件;
图73A是嵌入在图70的滑动件中的RFID标签的细部图;
图73B是在钉击发行程结束时切割的RFID标签的细部图;
图74示出了两个钉仓;
图75示出了端部执行器,其中图74的钉仓中的一个与端部执行器相容并且另一个钉仓与端部执行器不相容;
图76示出了根据至少一个实施方案的用于控制系统的算法;
图77示出了根据至少一个实施方案的包括RFID扫描器的柔性电路;
图78是外科钉仓包装的透视图,其中该包装包括容纳在其中的外科钉仓的识别特征;
图79是当图78的包装处于密封构型时与该包装集成的RFID系统的局部剖视图;
图80是当该包装处于未密封构型时图79的RFID系统的局部剖视图;
图81是与外科钉仓一起使用的保持器的透视图,其中保持器包括集成的RFID标签;
图82是从外科钉仓移除的图81的保持器的透视图;
图83是当保持器从外科钉仓移除时的图81和图82的RFID标签的细部图;
图84是包括RFID系统的外科钉仓的局部透视图,该RFID系统包括加长天线,其中该加长天线的一部分横穿组织切割构件的切割路径;
图85是RFID系统,该RFID系统包括RFID标签、集成到第一柔性电路层中的第一RFID扫描器和集成到第二柔性电路层中的第二RFID扫描器;
图86是在钉击发行程之前图85的RFID系统的通信路径的表示;
图87是在钉击发行程期间和之后图85的RFID系统的通信路径的表示;
图88是处于未锁定构型的钉击发闭锁系统的局部透视图;
图88A是处于解锁构型的图88的钉击发闭锁系统的阻挡螺栓组件的透视图;
图89是处于锁定构型的图88的钉击发锁闭系统的局部透视图;
图89A是处于锁定构型的图88A的阻挡螺栓组件的透视图;
图90是包括图88至图89A的仓闭锁组件的外科器械的马达控制电路图;
图91是被配置为使用加密协议来促进钉仓的组装和包装的制造过程的示意图;并且
图92是表示用于与外科系统一起使用的钉仓的认证的解密协议的流程图。
在所述若干视图中,对应的参考符号指示对应的部件。本文所述的范例以一种形式示出了本发明的某些实施方案,并且这种范例不应被解释为以任何方式限制本发明的范围。
具体实施方式
本申请的申请人拥有与本申请于同一日期提交且各自全文以引用方式并入本文的以下美国专利申请:
-名称为“METHOD FOR AUTHENTICATING THE COMPATIBILITY OF A STAPLECARTRIDGE WITH A SURGICAL INSTRUMENT”的代理人案卷号END9145USNP1/190235-1M;
-名称为“SURGICAL INSTRUMENT SYSTEM COMPRISING AN RFID SYSTEM”的代理人案卷号END9146USNP1/190236;
-名称为“SURGICAL INSTRUMENT COMPRISING AN RFID SYSTEM FOR TRACKING AMOVABLE COMPONENT”的代理人案卷号END9147USNP1/190237;
-名称为“SURGICAL INSTRUMENT COMPRISING AN ALIGNED RFID SENSOR”的代理人案卷号END9148USNP1/190238;
-名称为“SURGICAL STAPLING SYSTEM HAVING AN INFORMATION DECRYPTIONPROTOCOL”的代理人案卷号END9123USNP1/190239;
-名称为“SURGICAL STAPLING SYSTEM HAVING AN INFORMATION ENCRYPTIONPROTOCOL”的代理人案卷号END9124USNP1/190240;
-代理人案卷号为END9125USNP1/190241,标题为“SURGICAL STAPLING SYSTEMHAVING A LOCKOUT MECHANISM FOR AN INCOMPATIBLE CARTRIDGE”;以及
-代理人案卷号为END9126USNP1/190242,标题为“SURGICAL STAPLING SYSTEMHAVING A FRANGIBLE RFID TAG”。
本申请的申请人拥有与本申请于同一日期提交且各自全文以引用方式并入本文的以下美国专利申请:
-名称为“METHOD OF USING MULTIPLE RFID CHIPS WITH A SURGICAL ASSEMBLY”的代理人案卷号END9119USNP1/190245-1M;
-名称为“MECHANISMS FOR PROPER ANVIL ATTACHMENT SURGICAL STAPLING HEADASSEMBLY”的代理人案卷号END9120USNP1/190246;
-名称为“MECHANISMS FOR MOTOR CONTROL ADJUSTMENTS OF A MOTORIZEDSURGICAL INSTRUMENT”的代理人案卷号END9121USNP1/190247;
-名称为“SURGICAL INSTRUMENT WITH BATTERY COMPATIBILITY VERIFICATIONFUNCTIONALITY”的代理人案卷号END9122USNP1/190248;
-名称为“SURGICAL SYSTEM WITH RFID TAGS FOR UPDATING MOTOR ASSEMBLYPARAMETERS”的代理人案卷号END9131USNP1/190249;
-名称为“SURGICAL SYSTEMS WITH MULTIPLE RFID TAGS”的代理人案卷号END9132USNP1/190250;
-名称为“RFID IDENTIFICATION SYSTEMS FOR SURGICAL INSTRUMENTS”的代理人案卷号END9149USNP1/190251;
-名称为“RFID IDENTIFICATION SYSTEMS FOR SURGICAL INSTRUMENTS”的代理人案卷号END9150USNP1/190252;
-名称为“SURGICAL RFID ASSEMBLIES FOR DISPLAY AND COMMUNICATION”的代理人案卷号END9151USNP1/190253;
-名称为“SURGICAL RFID ASSEMBLIES FOR COMPATIBILITY DETECTION”的代理人案卷号END9152USNP1/190254;以及
-名称为“SURGICAL RFID ASSEMBLIES FOR INSTRUMENT OPERATIONAL SETTINGCONTROL”的代理人案卷号END9153USNP1/190255。
本申请的申请人拥有于2018年5月1日提交且各自全文以引用方式并入本文的以下美国专利申请:
-名称为“SURGICAL SUTURING SYSTEMS”的美国临时专利申请序列号62/665,129;
-名称为“SURGICAL INSTRUMENTS COMPRISING CONTROL SYSTEMS”的美国临时专利申请序列号62/665,139;
-名称为“SURGICAL INSTRUMENTS COMPRISING HANDLE ARRANGEMENTS”的美国临时专利申请序列号62/665,177;
-名称为“MODULAR SURGICAL INSTRUMENTS”的美国临时专利申请序列号62/665,128;
-名称为“SURGICAL DISSECTORS”的美国临时专利申请序列号62/665,192;以及
-名称为“SURGICAL CLIP APPLIER”的美国临时专利申请序列号62/665,134。
本申请的申请人拥有于2018年8月24日提交的各自全文以引用方式并入本文的以下美国专利申请:
-名称为“SURGICAL SUTURING INSTRUMENT CONFIGURED TO MANIPULATE TISSUEUSING MECHANICAL AND ELECTRICAL POWER”的美国专利申请序列号16/112,129;
-名称为“SURGICAL SUTURING INSTRUMENT COMPRISING A CAPTURE WIDTH WHICHIS LARGER THAN TROCAR DIAMETER”的美国专利申请序列号16/112,155;
-名称为“SURGICAL SUTURING INSTRUMENT COMPRISING A NON-CIRCULARNEEDLE”的美国专利申请序列号16/112,168;
-名称为“ELECTRICAL POWER OUTPUT CONTROL BASED ON MECHANICAL FORCES”的美国专利申请序列号16/112,180;
-名称为“REACTIVE ALGORITHM FOR SURGICAL SYSTEM”的美国专利申请序列号16/112,193;
-名称为“SURGICAL INSTRUMENT COMPRISING AN ADAPTIVE ELECTRICAL SYSTEM”的美国专利申请序列号16/112,099;
-名称为“CONTROL SYSTEM ARRANGEMENTS FOR A MODULAR SURGICALINSTRUMENT”的美国专利申请序列号16/112,112;
-名称为“ADAPTIVE CONTROL PROGRAMS FOR A SURGICAL SYSTEM COMPRISINGMORE THAN ONE TYPE OF CARTRIDGE”的美国专利申请序列号16/112,119;
-名称为“SURGICAL INSTRUMENT SYSTEMS COMPRISING BATTERY ARRANGEMENTS”的美国专利申请序列号16/112,097;
-名称为“SURGICAL INSTRUMENT SYSTEMS COMPRISING HANDLE ARRANGEMENTS”的美国专利申请序列号16/112,109;
-名称为“SURGICAL INSTRUMENT SYSTEMS COMPRISING FEEDBACK MECHANISMS”的美国专利申请序列号16/112,114;
-名称为“SURGICAL INSTRUMENT SYSTEMS COMPRISING LOCKOUT MECHANISMS”的美国专利申请序列号16/112,117;
-名称为“SURGICAL INSTRUMENTS COMPRISING A LOCKABLE END EFFECTORSOCKET”的美国专利申请序列号16/112,095;
-名称为“SURGICAL INSTRUMENTS COMPRISING A SHIFTING MECHANISM”的美国专利申请序列号16/112,121;
-名称为“SURGICAL INSTRUMENTS COMPRISING A SYSTEM FOR ARTICULATION ANDROTATION COMPENSATION”的美国专利申请序列号16/112,151;
-名称为“SURGICAL INSTRUMENTS COMPRISING A BIASED SHIFTING MECHANISM”的美国专利申请序列号16/112,154;
-名称为“SURGICAL INSTRUMENTS COMPRISING AN ARTICULATION DRIVE THATPROVIDES FOR HIGH ARTICULATION ANGLES”的美国专利申请序列号16/112,226;
-名称为“SURGICAL DISSECTORS AND MANUFACTURING TECHNIQUES”的美国专利申请序列号16/112,062;
-名称为“SURGICAL DISSECTORS CONFIGURED TO APPLY MECHANICAL ANDELECTRICAL ENERGY”的美国专利申请序列号16/112,098;
-名称为“SURGICAL CLIP APPLIER CONFIGURED TO STORE CLIPS IN A STOREDSTATE”的美国专利申请序列号16/112,237;
-名称为“SURGICAL CLIP APPLIER COMPRISING AN EMPTY CLIP CARTRIDGELOCKOUT”的美国专利申请序列号16/112,245;
-名称为“SURGICAL CLIP APPLIER COMPRISING AN AUTOMATIC CLIP FEEDINGSYSTEM”的美国专利申请序列号16/112,249;
-名称为“SURGICAL CLIP APPLIER COMPRISING ADAPTIVE FIRING CONTROL”的美国专利申请序列号16/112,253;以及
-名称为“SURGICAL CLIP APPLIER COMPRISING ADAPTIVE CONTROL IN RESPONSETO A STRAIN GAUGE CIRCUIT”的美国专利申请序列号16/112,257。
本申请的申请人拥有于2018年10月26日提交的各自全文以引用方式并入本文的以下美国专利申请:
-名称为“CLIP APPLIER COMPRISING INTERCHANGEABLE CLIP RELOADS”的美国专利申请序列号16/172,130;
-名称为“CLIP APPLIER COMPRISING A MOVABLE CLIP MAGAZINE”的美国专利申请序列号16/172,066;
-名称为“CLIP APPLIER COMPRISING A ROTATABLE CLIP MAGAZINE”的美国专利申请序列号16/172,078;
-名称为“CLIP APPLIER COMPRISING CLIP ADVANCING SYSTEMS”的美国专利申请序列号16/172,087;
-名称为“CLIP APPLIER COMPRISING A CLIP CRIMPING SYSTEM”的美国专利申请序列号16/172,094;
-名称为“CLIP APPLIER COMPRISING A RECIPROCATING CLIP ADVANCINGMEMBER”的美国专利申请序列号16/172,128;
-名称为“CLIP APPLIER COMPRISING A MOTOR CONTROLLER”的美国专利申请序列号16/172,168;
-名称为“SURGICAL SYSTEM COMPRISING A SURGICAL TOOL AND A SURGICALHUB”的美国专利申请序列号16/172,164;以及
-名称为“METHOD FOR OPERATING A POWERED ARTICULATING MULTI-CLIPAPPLIER”的美国专利申请序列号16/172,303。
本专利申请的申请人拥有于2018年12月4日提交的以下美国专利申请,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:
-名称为“METHOD OF HUB COMMUNICATION,PROCESSING,STORAGE AND DISPLAY”的美国专利申请序列号16/209,385;
-名称为“METHOD OF HUB COMMUNICATION”的美国专利申请序列号16/209,395;
-名称为“METHOD OF CLOUD BASED DATA ANALYTICS FOR USE WITH THE HUB”的美国专利申请序列号16/209,403;
-名称为“METHOD OF ROBOTIC HUB COMMUNICATION,DETECTION,AND CONTROL”的美国专利申请序列号16/209,407;
-名称为“METHOD OF HUB COMMUNICATION,PROCESSING,DISPLAY,AND CLOUDANALYTICS”的美国专利申请序列号16/209,416;
-名称为“METHOD OF COMPRESSING TISSUE WITHIN A STAPLING DEVICE ANDSIMULTANEOUSLY DISPLAYING THE LOCATION OF THE TISSUE WITHIN THE JAWS”的美国专利申请序列号16/209,423;
-名称为“METHOD OF USING REINFORCED FLEXIBLE CIRCUITS WITH MULTIPLESENSORS TO OPTIMIZE PERFORMANCE OF RADIO FREQUENCY DEVICES”的美国专利申请序列号16/209,427;
-名称为“METHOD OF SENSING PARTICULATE FROM SMOKE EVACUATED FROM APATIENT,ADJUSTING THE PUMP SPEED BASED ON THE SENSED INFORMATION,ANDCOMMUNICATING THE FUNCTIONAL PARAMETERS OF THE SYSTEM TO THE HUB”的美国专利申请序列号16/209,433;
-名称为“METHOD FOR SMOKE EVACUATION FOR SURGICAL HUB”的美国专利申请序列号16/209,447;
-名称为“METHOD FOR CONTROLLING SMART ENERGY DEVICES”的美国专利申请序列号16/209,453;
-名称为“METHOD FOR SMART ENERGY DEVICE INFRASTRUCTURE”的美国专利申请序列号16/209,458;
-名称为“METHOD FOR ADAPTIVE CONTROL SCHEMES FOR SURGICAL NETWORKCONTROL AND INTERACTION”的美国专利申请序列号16/209,465;
-名称为“METHOD FOR SITUATIONAL AWARENESS FOR SURGICAL NETWORK ORSURGICAL NETWORK CONNECTED DEVICE CAPABLE OF ADJUSTING FUNCTION BASED ON ASENSED SITUATION OR USAGE”的美国专利申请序列号16/209,478;
-名称为“METHOD FOR FACILITY DATA COLLECTION AND INTERPRETATION”的美国专利申请序列号16/209,490;以及
-名称为“METHOD FOR CIRCULAR STAPLER CONTROL ALGORITHM ADJUSTMENTBASED ON SITUATIONAL AWARENESS”的美国专利申请序列号16/209,491。
现在将描述某些示例性实施方案,以提供对本文所公开的装置和方法的结构、功能、制造和用途的原理的全面理解。这些实施方案的一个或多个示例在附图中示出。本领域的普通技术人员将会理解,在本文中具体描述并示出于附图中的装置和方法为非限制性的示例性实施方案,并且本发明的各种实施方案的范围仅由权利要求书限定。结合一个示例性实施方案示出或描述的特征部可与其它实施方案的特征部进行组合。此类修改和变型旨在包括在本发明的范围之内。
本说明书通篇提及的“各种实施方案”、“一些实施方案”、“一个实施方案”或“实施方案”等意味着结合实施方案描述的具体特征、结构或特性包括在至少一个实施方案中。因此,本说明书通篇出现的短语“在各种实施方案中”、“在一些实施方案中”、“在一个实施方案中”或“在实施方案中”等并不一定都指相同的实施方案。此外,在一个或多个实施方案中,具体特征结构、结构或特性可以任何合适的方式组合。因此,在无限制的情况下,结合一个实施方案示出或描述的具体特征、结构或特性可全部或部分地与一个或多个其他实施方案的特征、结构或特性组合。此类修改和变型旨在包括在本发明的范围之内。
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,并且术语“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,外科器械在许多取向和方位中使用,并且这些术语并非是限制性的和/或绝对的。
提供各种示例性装置和方法以用于执行腹腔镜式和微创外科手术。然而,本领域的普通技术人员将容易理解,本文所公开的各种方法和装置可用于许多外科手术和应用中,包括例如与开放式外科手术相结合。继续参阅本具体实施方式,本领域中的普通技术人员将进一步理解,本文所公开的各种器械可以任何方式插入体内,诸如通过自然腔道、通过形成于组织中的切口或穿刺孔等。器械的工作部分或端部执行器部分可被直接插入患者体内或可通过具有工作通道的进入装置插入,外科器械的端部执行器及细长轴可通过所述工作通道而推进。
外科缝合系统可包括轴和从轴延伸的端部执行器。所述端部执行器包括第一钳口和第二钳口。第一钳口包括钉仓。钉仓能够插入到第一钳口中并且能够从第一钳口移除;然而,设想到其中钉仓不能够从第一钳口移除或至少能够易于从第一钳口替换的其他实施方案。第二钳口包括被构造成能够使从钉仓射出的钉变形的砧座。第二钳口能够围绕闭合轴线相对于第一钳口枢转;然而,可设想到其中第一钳口能够相对于第二钳口枢转的其他实施方案。外科缝合系统还包括被构造成能够允许端部执行器相对于轴旋转或进行关节运动的关节运动接头。端部执行器能够围绕延伸穿过关节运动接头的关节运动轴线旋转。设想了不包括关节运动接头的其他实施方案。
钉仓包括仓体。仓体包括近侧端部、远侧端部和在近侧端部与远侧端部之间延伸的平台。在使用中,钉仓被定位在待缝合的组织的第一侧上,并且砧座被定位在组织的第二侧上。砧座朝向钉仓运动以将组织压缩并抵靠平台夹持。然后,可移除地储存在仓体中的钉可被部署到组织中。仓体包括限定于仓体中的钉腔,其中钉可移除地储存在钉腔中。钉腔被布置成六个纵向排。三排钉腔被定位在纵向狭槽的第一侧上且三排钉腔被定位在纵向狭槽的第二侧上。钉腔和钉的其他布置结构也是可能的。
钉由仓体中的钉驱动器支撑。驱动器能够在第一或非击发位置和第二或击发位置之间运动,以从钉仓射出钉。驱动器通过保持器保留在仓体中,所述保持器围绕仓体的底部延伸并且包括被构造成能够抓持仓体以及将保持器保持至仓体的弹性构件。驱动器能够通过滑动件在其非击发位置与其击发位置之间运动。滑动件能够在与近侧端部相邻的近侧位置和与远侧端部相邻的远侧位置之间运动。滑动件包括多个斜坡表面,该斜坡表面被构造成能够朝向砧座在驱动器下方滑动以及提升驱动器,并且钉在驱动器上受到支撑。
除上述以外,滑动件还可通过击发构件朝远侧运动。击发构件被构造成能够接触滑动件并朝向远侧端部推动滑动件。限定于仓体中的纵向狭槽被构造成能够接纳击发构件。砧座还包括被构造成能够接纳击发构件的狭槽。击发构件还包括接合第一钳口的第一凸轮和接合第二钳口的第二凸轮。随着击发构件朝远侧推进,第一凸轮和第二凸轮可控制钉仓的平台和砧座之间的距离或组织间隙。击发构件还包括被构造成能够切入在钉仓和砧座中间捕获的组织的刀。希望刀定位成至少部分接近斜坡表面,使得钉先于刀被射出。
图1至图3示出了示例性外科器械100,该外科器械包括柄部103、轴104和在关节运动接头110处枢转地连接到轴104的关节运动端部执行器102。提供关节运动控件112以实现端部执行器102围绕关节运动接头110的旋转。端部执行器102包括用于夹紧、切断和缝合组织的内镜切割器;然而,应当理解,各种实施方案可包括被构造成能够用作其他外科装置的端部执行器,包括例如抓紧器、切割器、缝合器、施夹钳、进入装置、药物/基因治疗递送装置、超声、RF和/或激光能量装置等。器械100的柄部103包括用于致动端部执行器102的闭合触发器114和击发触发器116。应当理解,具有涉及不同外科任务的端部执行器的器械可具有用于操作端部执行器的不同数量或类型的触发器或其他合适的控件。端部执行器102通过轴104连接到柄部103。临床医生可以通过利用关节运动控件112使端部执行器102相对于轴104关节运动,如下文进一步更详细地描述。
应当理解,空间术语例如垂直、水平、右、左等在本文中参考附图给出,假设外科器械100的纵向轴线与轴104的中心轴线同轴,触发器114、116从柄部103的底部以锐角向下延伸。然而,在实际实践中,外科器械100可以各种角度取向,并且因此这些空间术语相对于外科器械100本身使用。另外,近侧用于表示在柄部103后面的临床医生的视角,该临床医生将端部执行器102放置在远侧或远离他或她自己。如本文所用,短语“基本上横向于纵向轴线”是指几乎垂直于纵向轴线的方向,其中“纵向轴线”是轴的轴线。然而,应当理解,有些偏离垂直于纵向轴线的方向也基本上横向于纵向轴线。
本文所公开的各种实施方案涉及具有由弯曲电缆或带驱动的关节运动接头的器械。图4和图5示出了细长轴104和端部执行器102的剖视顶视图,该端部执行器包括带205,该带机械地联接到从端部执行器102延伸的凸台206。带205可包括沿着细长轴104从凸台206向近侧延伸并且穿过关节运动控件112的带部分202和204。带205和带部分202、204可具有固定长度。带205可以如使用任何合适的紧固方法机械地联接到凸台206,包括例如胶粘、焊接等。在各种实施方案中,每个带部分202、204可以作为单独的带提供,其中每个单独的带具有机械地联接到凸台206的一端和延伸穿过轴104和关节运动控制器112的另一端。单独的带可如上所述机械地联接到凸台206。
除上述之外,带部分202、204可从凸台206延伸穿过关节运动接头110并且沿着轴104延伸到关节运动控件112,如图6所示。关节运动控件112可包括关节运动滑动件208、框架212和壳体218。带部分202、204可经过狭槽210或其他孔穿过关节运动滑动件208,但是应当理解,带部分202、204可通过任何合适的方式联接到滑动件208。关节运动滑动件208可以是一体式的,如图6所示,或者可以包括两个部件,这两个部件之间的接合部限定狭槽210。在一个非限制性实施方案中,关节运动滑动件208可包括多个狭槽,例如每个狭槽被构造成能够接收带部分202、204中的一者。壳体218可覆盖关节运动控件112的各种部件,以防止碎屑进入关节运动控件112。
再次参见图6,带部分202、204可分别在位于狭槽210近侧的连接点214、216处锚定到框架212。应当理解,带部分202、204可锚定在器械10中位于狭槽210近侧的任何位置,包括柄部103。图6的非限制性实施方案示出了带部分202、204可包括连接点214、216与位于轴104的纵向轴线附近的狭槽210之间的弯曲构型。设想了其他实施方案,其中带部分202、204是直的。
图7至图9示出了器械100的端部执行器102和细长轴104的视图,包括图5所示的关节运动接头110。图7示出了端部执行器102和细长轴104的分解视图,包括各种内部部件。在至少一个实施方案中,端部执行器框架150和轴框架154被构造成能够在关节运动接头110处接合。凸台206可与端部执行器框架150成一体,带205与凸台206介接,如图所示。轴框架154可包括限定孔304的远侧定向柄302。孔304可被定位成介接端部执行器框架150中包括的关节运动销(未示出),从而允许端部执行器框架150相对于轴框架154枢转,并且因此端部执行器102相对于轴104枢转。当组装时,各种部件可在图9和图10所示的关节运动轴线306处绕关节运动接头110枢转。
图7还示出了砧座120。在该非限制性实施方案中,砧座120联接到细长通道198。例如,孔199可限定在细长通道198中,该孔可接收从砧座120延伸的销152并允许砧座120相对于细长通道198和钉仓118从打开位置枢转到闭合位置。另外,图7示出了击发杆172,其被构造成能够纵向平移穿过轴框架154、穿过柔性封闭装置和枢转框架关节运动接头110,并且穿过远侧框架150中的击发狭槽176进入端部执行器102。击发杆172可由一个实心部分构成,或在各种实施方案中,可包括层合材料,该层合材料包括例如一叠钢板。应当理解,由层合材料制成的击发杆172可减小使端部执行器102进行关节运动所需的力。在各种实施方案中,弹簧夹158可安装在端部执行器框架150中以使击发杆172向下偏置。在端部执行器框架150的顶部上形成的远侧正方形孔164和近侧正方形孔168可在其间限定夹杆170,该夹杆接收弹簧夹158的上臂162,该弹簧夹的向远侧延伸的下臂160在击发杆172的凸起部分174上施加向下的力,如下所述。
击发杆172的远侧突出端可附接到E型横梁178,该E型横梁可(除了其他以外)在砧座120处于闭合位置时有助于将砧座120与定位在细长通道198中的钉仓118间隔开。E型横梁178还可包括锋利切割边缘182,当通过击发杆172向远侧推进E型横梁178时,该切割边缘可用于切断组织。在操作中,E型横梁178还可致动或击发钉仓118。钉仓118可包括模塑的仓体194,该仓体保持多个钉191,这些多个钉安置在钉驱动器192上,这些钉驱动器位于分别向上打开的钉腔195中。楔形滑动件190通过E型横梁178朝远侧驱动,从而在仓托盘196上滑动,该仓托盘将可替换钉仓118的各种部件保持在一起。楔形滑动件190使钉驱动器192向上进行凸轮运动,以将钉191挤出成与砧座120变形接触,同时E型横梁178的切割表面182切断夹持的组织。
除上述之外,E形横梁178可包括在击发期间接合砧座120的上部销180。E形横梁178还可包括中间销184和底脚186,其可接合仓体194、仓托盘196和细长通道198的各个部分。当钉仓118定位在细长通道198内时,限定在仓体194中的狭槽193可与限定在仓托盘196中的狭槽197以及限定在细长通道198中的狭槽189对齐。在使用中,E形横梁178可滑动穿过对齐的狭槽193、197和189,其中如图7所示,E形横梁178的底部基座186可沿着狭槽189的长度接合沿着通道198的底面延伸的沟槽,中间销184可沿着纵向狭槽197的长度接合仓托盘196的顶部表面,并且上部销180可接合砧座120。在这种情况下,当击发杆172向远侧移动以从钉仓118击发钉并且/或者切入砧座120和钉仓118之间捕集的组织时,E型横梁178可分开或限制砧座120和钉仓118之间的相对移动。然后,击发杆172和E形横梁178可朝近侧回缩,从而允许砧座120被打开,以释放两个缝合和切割的组织部分(未示出)。
图7至图9还示出了根据各种实施方案的双枢轴闭合套管组件121。具体参见图7,双枢轴闭合套管组件121包括具有朝远侧突出的上柄脚146和下柄脚148的轴闭合管区段128。端部执行器闭合管区段126包括用于接合砧座120上的打开插片122的马蹄形孔124和插片123。当砧座120打开时,马蹄形孔124和插片123接合插片122。闭合管区段126被示出为具有朝近侧突出的上柄脚144和下柄脚(不可见)。上部双枢轴连接件130包括向上突出的远侧枢轴销134和近侧枢轴销136,这些枢轴销分别接合朝近侧突出的上柄脚144中的上部远侧销孔138和朝远侧突出的上柄脚146中的上部近侧销孔140。下部双枢轴连接件132包括向下突出的远侧枢轴销和近侧枢轴销(图7中未示出但图8中示出),这些枢轴销分别接合朝近侧突出的下柄脚中的下部远侧销孔和朝远侧突出的下柄脚148中的下部近侧销孔142。
在使用中,闭合管组件121朝远侧平移,以例如响应于闭合触发器114的致动来将砧座120闭合。通过向远侧平移闭合管区段126并且因此向远侧平移套管组件121,使其撞击插片122左侧的位于图9A中的砧座120上的近侧表面,由此使砧座120闭合。如在图8和图9中更清楚地所示,通过朝近侧平移管区段126和套管组件121,致使插片123和马蹄形孔124接触并推压插片122以将砧座120抬起,由此打开砧座120。在砧座打开位置,双枢轴闭合套管组件121移动到其近侧位置。
在操作中,临床医生可通过横向推动控件112而使器械100的端部执行器102相对于轴104围绕枢轴110进行关节运动。从中间位置,临床医生可以通向控件112的左侧提供横向力而使端部执行器102相对于轴104向左进行关节运动。响应于力,关节运动滑动件208可至少部分地被推入框架212中。当滑动件208被推入框架212中时,狭槽210以及带部分204可以在横向方向上(例如,基本上横向于或垂直于轴104的纵向轴线的方向)跨细长轴104平移。因此,向带部分204施加力,使其弹性地弯曲和/或从其初始预弯曲位置朝向轴104的相对侧移位。同时,带部分202从其初始预弯曲位置松弛。带部分204的这种移动连同带部分202的拉直可在凸台206处施加逆时针旋转力,这又使凸台206和端部执行器102围绕关节运动枢轴110枢转到相对于轴104的轴线的期望角度,如图12所示。带部分202的松弛减小了这个带部分上的张力,从而允许带部分204使端部执行器102进行关节运动而没有来自带部分202的明显干扰。应当理解,临床医生还可以通过向控件112的右侧提供横向力来使端部执行器102相对于轴104向右进行关节运动。这使电缆部分202弯曲,从而在凸台206处引起顺时针旋转力,这又使凸台206和端部执行器围绕关节运动枢轴110向右枢转。与上述类似,带部分204可以同时放松以允许这种移动。
图12和图13示出了马达驱动的外科切割和紧固器械310。该例示的实施方案示出了内窥镜式器械,并且一般来讲,器械310在本文中被描述为内窥镜式外科切割和紧固器械;然而,应当注意,本发明不限于此,并且根据其他实施方案,本文所公开的任何器械可包括非内窥镜式外科切割和紧固器械。图12和图13中示出的外科器械310包括柄部306、轴308和连接到轴308的端部执行器312。在各种实施方案中,端部执行器312可围绕关节运动接头314相对于轴308进行关节运动。用于使端部执行器312进行关节运动的各种装置和/或用于允许端部执行器312相对于轴308进行关节运动的装置在公布于2010年7月13日、名称为“SURGICAL STAPLING INSTRUMENTS”的美国专利7,753,245和公布于2010年3月2日、名称为“SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR”的美国专利7,670,334中公开,这些专利的全部公开内容以引用方式并入本文。下文更详细地论述用于使端部执行器312进行关节运动的各种其他装置。与上述类似,端部执行器312被构造成能够充当用于夹紧、切断和/或缝合组织的直线切割器,但在其他实施方案中,可以使用不同类型的端部执行器,例如用于抓紧器、切割器、缝合器、施夹钳、进入装置、药物/基因治疗装置、超声、RF和/或激光装置等其他类型外科装置的端部执行器。若干RF装置可在1995年4月4日公布的名称为“ELECTROSURGICAL HEMOSTATIC DEVICE”的美国专利5,403,312,和2008年2月14日提交的名称为“SURGICAL CUTTING AND FASTENING INSTRUMENT HAVING RFELECTRODES”的美国专利申请序列号12/031,573中找到,这些专利的完整公开内容全文以引用方式并入。
应当理解,本文使用的术语“近侧”和“远侧”是相对于抓持器械310的手柄306的临床医生而言的。因此,端部执行器312相对于更近侧的柄部部分306位于远侧。还应当理解,为便利和清楚起见,本文结合图示使用空间术语诸如“垂直”和“水平”。然而,外科器械在许多取向和位置中使用,并且这些术语并非旨在为限制性的和绝对的。
例如,端部执行器312可包括钉通道322和能够枢转地平移的夹紧构件,诸如砧座324。器械310的柄部306可包括用于致动端部执行器312的闭合触发器318和击发触发器320。应当理解,具有涉及不同外科任务的端部执行器的器械可具有用于操作端部执行器312的不同数量或类型的触发器或其他合适的控件。柄部306可包括向下延伸的手枪式握持部326,临床医生将闭合触发器318枢转地拉向该手枪式握持部,以使砧座324朝端部执行器312的钉通道322夹持或闭合,从而夹持定位在砧座324和通道322之间的组织。在其他实施方案中,可使用除砧座324之外或代替该砧座的不同类型的夹紧构件。柄部306还可包括锁,该锁可被构造成能够将闭合触发器318可释放地保持在其闭合位置。有关用于通过回缩闭合触发器318来闭合(或夹紧)端部执行器312的砧座324的示例性闭合系统的实施方案的更多详细信息在公布于2006年2月21日、名称为“SURGICAL STAPLING INSTRUMENT HAVINGSEPARATE DISTINCT CLOSING AND FIRING SYSTEMS”的美国专利7,000,818,公布于2008年9月9日、名称为“MOTOR-DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITHTACTILE POSITION FEEDBACK”的美国专利7,422,139和公布于2008年12月16日、名称为“ELECTRO-MECHANICAL SURGICAL INSTRUMENT WITH CLOSURE SYSTEM AND ANVILALIGNMENT COMPONENTS”的美国专利7,464,849中提供,这些专利的全部公开内容以引用方式并入本文。
一旦临床医生满意端部执行器312的定位,临床医生就可将闭合触发器318退回到其接近手枪式握持部326的完全闭合锁定位置。然后可致动或击发触发器320。在至少一个这样的实施方案中,击发触发器320可位于闭合触发器318的外侧更远,其中闭合触发器318的闭合可使击发触发器320朝手枪式握持部326移动或旋转,使得操作者在各种情况下可使用一只手来到达击发触发器320。此后,操作者可将击发触发器320朝手枪式握持部312枢转地拉动,以使得缝合和切断端部执行器312中的夹紧组织。此后,在临床医生松弛或释放施加到击发触发器320的力之后,击发触发器320可返回到其未致动或未击发位置(如图1和图2所示)。在按压时,柄部306上的释放按钮可释放锁定的闭合触发器318。释放按钮可采用各种形式实现,诸如例如公开于2006年1月31日提交的名称为“SURGICAL CUTTING ANDFASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKING MECHANISM”的已公布的美国专利申请公布2007/0175955中的那些,该专利申请的全部公开内容以引用方式全文并入本文。
除上述之外,端部执行器312可包括例如用于当击发触发器320被用户回缩时切割夹在端部执行器312中的组织的切割器械,诸如刀。另外除上述之外,端部执行器312还可包括例如用于紧固被切割器械切割的组织的装置,诸如钉、RF电极和/或粘合剂。位于器械310的轴308内的可纵向移动的驱动轴可驱动/致动端部执行器312中的切割器械和紧固装置。位于器械310的柄部306中的电动马达可用于驱动该驱动轴,如本文进一步所述。在各种实施方案中,马达可为具有例如约25,000RPM的最大转速的DC有刷驱动马达。在其他实施方案中,该马达可包括无刷马达、无绳马达、同步马达、步进马达,或任何其他合适的电动马达。电池(或“电源”或“电源组”)诸如例如锂离子电池可设置在柄部6的与马达相邻的手枪式握持部26中,其中电池可以经由马达控制电路向马达供应电力。根据各种实施方案,串联连接的多个电池单元可用作电源以向马达供电。此外,电源可为可替换的和/或可充电的。
如上文所概述,器械310的柄部306中的电动马达可与位于轴308内的可纵向移动的驱动构件可操作地接合。现在参见图14至图16,电动马达342可安装到柄部306的手枪式握持部326并且位于该手枪式握持部内。电动马达342可包括与齿轮减速器组件370可操作地联接的能够旋转的轴,其中齿轮减速器组件370可包括外壳374和输出小齿轮372等。在某些实施方案中,输出小齿轮372可直接与可纵向移动的驱动构件382可操作地接合,或者另选地能够经由一个或多个中间齿轮386与驱动构件382可操作地接合。在至少一个这样的实施方案中,中间齿轮386可与限定在驱动构件382中的一组或一排驱动齿384啮合地接合。在使用中,电动马达342可将驱动构件向远侧驱动,由箭头D(图15)指示,以及/或者将驱动构件向近侧驱动,由箭头D(图16)指示,具体取决于电动马达342旋转中间齿轮386的方向。在使用中,电池所提供的电压极性可沿顺时针方向操作电动马达342,其中由电池施加到电动马达的电压极性可被反转,以便沿逆时针方向操作电动马达342。柄部306可包括开关,该开关可被构造成能够使由电池施加到电动马达342的极性反转。柄部306还可包括被构造成能够检测驱动构件382的位置和/或驱动构件382移动的方向的传感器330。
如上所述,外科器械310可包括关节运动接头314,端部执行器312可围绕该关节运动接头进行关节运动。器械310还可包括关节运动锁,该关节运动锁可被构造成并且操作以选择性地将端部执行器312锁定就位。在至少一个这样的实施方案中,关节运动锁可从轴308的近侧端部延伸到轴308的远侧端部,其中该关节运动锁的远侧端部可接合端部执行器312以将端部执行器312锁定就位。再次参见图12和图13,器械310还可包括关节运动控件316,该关节运动控件可与关节运动锁的近侧端部接合并且可被构造成能够使关节运动锁在锁定状态与解锁状态之间操作。在使用中,可向近侧拉动关节运动控件316以解锁端部执行器312并且允许端部执行器312围绕关节运动接头314旋转。在端部执行器312已经适当地进行关节运动之后,关节运动控件316可向远侧移动以将端部执行器312重新锁定就位。在至少一个这样的实施方案中,柄部306还可包括弹簧和/或被构造成能够向远侧偏置关节运动控件316和将关节运动锁偏置成与端部执行器312的锁定构型的其他合适的偏置元件。如果临床医生期望,临床医生可以再次将关节运动控件316拉回或向近侧拉动以解锁端部执行器312,使端部执行器312进行关节运动,然后将关节运动控件316移回其锁定状态。在这种锁定状态下,端部执行器312可能不会相对于轴308进行关节运动。
如上文所概述,外科器械310可包括被构造成能够将端部执行器312相对于轴308保持就位的关节运动锁。如上所述,当关节运动锁处于其解锁状态时,端部执行器312可相对于轴308旋转或进行关节运动。在这种解锁状态下,端部执行器312可抵靠例如围绕患者体内手术部位的软组织和/或骨定位和推压,以使端部执行器312相对于轴308做关节运动。在某些实施方案中,关节运动控件316可包括关节运动开关,或者可被构造成能够操作关节运动开关,该关节运动开关可选择性地允许和/或阻止击发触发器320操作电动马达342。例如,这种关节运动开关可与电动马达342和可操作地与击发触发器320相关联的击发开关串联放置,其中当关节运动控件316处于锁定状态时,该关节运动开关可处于闭合状态。当关节运动控件316移动到解锁状态时,关节运动控件316可打开关节运动开关,从而使击发触发器320的操作和电动马达342的操作解除电联接。在此类情况下,当端部执行器312处于解锁状态并且能够相对于轴308进行关节运动时,器械310的击发驱动装置不能被击发。当关节运动控件316返回其锁定状态时,关节运动控件316可重新闭合关节运动开关,该关节运动开关然后可将击发触发器320的操作与电动马达342电联接。一种或多种外科缝合器械的各种细节公开于2009年12月24日提交的、名称为“MOTOR-DRIVEN SURGICAL CUTTINGINSTRUMENT WITH ELECTRIC ACTUATOR DIRECTIONAL CONTROL ASSEMBLY”的美国专利申请序列号12/647,100中,该申请在2011年6月30日作为美国专利申请公布2011/0155785公布,现为美国专利8,220,688,其全部公开内容以引用方式并入本文。
现在转到图17至图29,外科器械400可包括柄部403、从柄部403延伸的轴404,和从轴404延伸的端部执行器402。如读者将注意到的,出于说明的目的,已经移除了柄部403的部分;然而,柄部403可包括类似于例如图1所示的闭合触发器114和击发触发器116的闭合触发器和击发触发器。如将在下文更详细地描述的,击发触发器116可与包括延伸穿过轴404的击发构件470的击发驱动装置可操作地联接,其中击发触发器116的操作可使击发构件470朝端部执行器402向远侧推进。如同样将在下文更详细地描述的,外科器械400还可包括关节运动驱动装置,该关节运动驱动装置可选择性地与击发构件470联接,使得当击发构件470被击发触发器116和/或被例如单独的关节运动触发器和/或按钮促动时,该关节运动驱动装置可由击发构件470驱动,并且该关节运动驱动装置又可使端部执行器402围绕关节运动接头410进行关节运动。
现在转到图17,读者将注意,外科器械400的端部执行器402以打开构型示出。更具体地,端部执行器402的包括砧座420的第一钳口被示出为相对于端部执行器402的第二钳口的通道498处于打开位置。与上述类似,通道498可被构造成能够将钉仓接收和固定在其中。现在转到图20,该图也示出了处于打开构型的端部执行器420,外科器械400的柄部403可包括关节运动锁致动器409,该关节运动锁致动器可在远侧或锁定位置和近侧或解锁位置之间移动,在远侧或锁定位置,端部执行器402相对于轴404锁定就位,在近侧或解锁位置,端部执行器402可相对于轴404围绕关节运动接头410进行关节运动。尽管端部执行器402和轴404在图20中被示为以笔直构型对准,但是关节运动锁致动器409被示出为处于其回缩、解锁位置,并且因此端部执行器402可相对于轴404进行关节运动。参见图19、图24A和图24B,关节运动锁致动器409(图21)可与关节运动锁443可操作地联接,其中关节运动锁致动器409可使关节运动锁443在远侧位置(图24A)和近侧位置(图24B)之间移动,在远侧位置,关节运动锁443与端部执行器402的近侧锁构件407接合,在近侧位置,关节运动锁443与端部执行器402脱离。如读者将理解的,关节运动锁致动器409的远侧锁定位置对应于关节运动锁443的远侧位置,并且关节运动锁致动器409的近侧解锁位置对应于关节运动锁443的近侧位置。现在转到图19,关节运动锁443通过关节运动锁杆440联接到关节运动锁致动器409,该关节运动锁杆包括与关节运动锁443接合的远侧端部442(如图24A中更清楚地看到的),和与关节运动锁致动器409接合的近侧端部441(如图22中更清楚地看到的)。如图24A和图24B所示,关节运动锁443可包括一个或多个齿445,这些齿可被构造成能够例如啮合地接合围绕近侧锁构件407的周边限定的一个或多个齿446。主要参见图19,轴404还可包括偏置构件诸如例如弹簧444,该偏置构件可被构造成能够将关节运动锁443的齿445偏置成与端部执行器402的近侧锁构件407的齿446接合。类似地,柄部403还可包括位于在关节运动锁致动器409与框架480之间限定的腔488(图23)内的偏置构件,使得该偏置构件可将关节运动锁致动器409推向其远侧锁定位置。
如图17所示,关节运动锁致动器409可由两个喷嘴半部或部分即411a和411b构成,其中如读者将注意到的,出于说明的目的已从图18至图27移除了喷嘴部分411b。同样如图17所示,关节运动锁致动器409可包括多个指钩413,这些指钩可由外科医生或其他临床医生抓握,以便使关节运动锁致动器409回缩成其近侧解锁构型。再次参见图20,关节运动锁致动器409还可包括止动器组件452,该止动器组件可被构造成能够使止动构件457抵靠轴404的框架或柄部403的框架偏置。更具体地,轴404可包括从柄部框架480延伸的轴框架454,其中止动器组件452可被构造成能够使止动构件457抵靠轴框架454偏置。参见图19,轴框架454可包括限定在其中的止动通道453,该止动通道可与止动构件457对准,使得当关节运动锁致动器409在其锁定位置与解锁位置之间滑动时,止动构件457可在止动通道453内滑动。再次参见图20,止动器组件452可包括固定框架部分458,该固定框架部分可限定被构造成能够接收可调螺纹构件459的螺纹孔。可调螺纹构件459可包括内部孔,其中止动构件457的至少一部分可位于该内部孔内,并且其中止动构件457可被弹簧偏置到该内部孔的端部,该弹簧例如位于例如止动构件457和该内部孔的封闭端中间。如图19所示,止动通道453的近侧端部可包括止动座455,该止动座可被构造成能够当关节运动锁致动器409已经到达其近侧解锁位置时可移除地接收止动构件457。在各种情况下,止动构件457、止动座455和位于可调螺纹构件459中的偏置弹簧的尺寸可被设定和构造成使得止动器组件452可将关节运动锁致动器409可释放地保持在其近侧解锁位置。如下文更详细地描述的,关节运动锁致动器409可保持在其近侧解锁位置,直到端部执行器402已经适当地进行了关节运动。此时,可向前推动关节运动锁致动器409以使止动构件457与止动座455脱离。如读者将理解的,主要参见图20,可调螺纹构件459可朝轴框架454向下旋转,以便增大使止动构件457从止动座455离位所需的力,同时可调螺纹构件459可向上旋转远离轴框架454,以便减小使止动构件457从止动座455离位所需的力。同样如图20所示,关节运动锁致动器409可包括可以用于接近和旋转螺纹构件459的入口418。
如上所述,关节运动锁致动器409在图20中处于回缩解锁位置,并且端部执行器402处于解锁构型,如图24B所示。现在参见图19和图20,外科器械400还包括关节运动驱动器460,该关节运动驱动器可被向远侧推动以使端部执行器402围绕关节运动接头410在第一方向上旋转,并且被向近侧拉动以使端部执行器402围绕该关节运动接头在第二或相反的方向上旋转,如图21所示。在比较图20和图21时,读者将注意到,关节运动驱动器460已被击发构件470向近侧拉动。更具体地,击发构件470的中间部分475可包括限定在其中的凹口或狭槽476,该凹口或狭槽可被构造成能够接收关节运动驱动器460的近侧端部461,使得当击发构件470被向近侧拉动时,击发构件470也可向近侧拉动关节运动驱动器460。类似地,当击发构件470被向远侧推动时,击发构件470可向远侧推动关节运动驱动器460。同样如图20和图21所示,关节运动驱动器460可包括与从近侧锁构件407延伸的突出部414接合的远侧端部462,该突出部例如可被构造成能够将关节运动驱动器460的近侧和远侧关节运动传输到端部执行器102。主要参见图18至图20,柄部404还可包括击发构件470的近侧击发构件部分482,该近侧击发构件部分包括与击发构件470的中间部分475的近侧端部477接合的远侧端部481。与上述类似,柄部403可包括电动马达,该电动马达包括输出轴和与输出轴可操作地接合的齿轮,其中该齿轮可能够与限定在击发构件部分482的表面上的一组纵向齿484操作地接合。在使用中,除上述之外,电动马达可在第一方向上操作以使击发构件470向远侧推进,和在第二或相反的方向上操作以使击发构件470向近侧回缩。尽管未示出,但是柄部403还可包括开关,该开关可处于第一状态以使电动马达在其第一方向上操作,可处于第二状态以使电动马达在其第二方向上操作,和/或可处于中性状态,这时电动马达不在任一方向上操作。在至少一个这样的实施方案中,该开关可包括至少一个偏置构件,诸如例如弹簧,该偏置构件可被构造成能够例如将开关偏置成其中性状态。而且,在至少一个这样的实施方案中,关节运动开关的第一状态可包括开关切换件的第一位置位于中性位置的第一侧上,并且关节运动开关的第二状态可包括该开关切换件的第二位置位于该中性位置的第二或相对侧上。
在各种情况下,除上述之外,该关节运动开关可用于在端部执行器402的位置进行小调节。例如,外科医生可沿第一方向移动关节运动开关以使端部执行器402围绕关节运动接头在第一方向上旋转,然后通过在第二方向上移动关节运动开关和/或第一和第二方向上的移动的任何其他合适的组合来反转端部执行器402的移动,直到端部执行器402定位在期望的位置。主要参见图19、图24A和图24B,关节运动接头410可包括从轴框架构件451延伸的枢轴销405,并且还包括限定在近侧锁构件407中的孔408,该孔被构造成能够将枢轴销405紧密地接收在其中,使得端部执行器402的旋转被限制为例如围绕关节运动轴线406旋转。主要参见图19,轴框架454的远侧端部可包括凹陷部456,该凹陷部被构造成能够将轴框架构件451接收在其中。如将在下文更详细地描述的,轴404可包括外套管,所述外套管可相对于轴框架454滑动以便闭合砧座420。主要参见图19至图21,轴410的外套管可包括近侧部分428和远侧部分426,这两个部分可通过关节运动连接件430和432彼此连接。当外套管相对于关节运动接头410滑动时,关节运动连接件430可在端部执行器402已经进行关节运动时适应外套管的远侧部分426与近侧部分428之间的成角度的相对移动,如图21所示。在各种情况下,关节运动连接件430和432可在关节运动接头410处提供两个或更多个自由度,以便适应端部执行器402的关节运动。读者还将注意到,关节运动接头410还可包括引导件401,该引导件可被构造成能够将击发构件470的远侧切割部分472接收在其中,并且当远侧切割部分472在关节运动接头410内和/或相对于该关节运动接头向远侧推进和/或向近侧回缩时引导该远侧切割部分。
如上文所概述,击发构件470可向远侧推进,以便向远侧推进关节运动驱动器460,并且因此端部执行器402在第一方向上旋转,类似地,击发构件470可向近侧回缩,以便向近侧回缩关节运动驱动器460,并且因此使端部执行器402在相反方向上旋转。然而,在一些情况下,当利用击发构件470使端部执行器402进行关节运动时,可能不希望移动或至少基本上移动击发构件470的远侧切割部分472。现在转到图19至图21,击发构件470的中间部分475可包括限定在其远侧端部中的纵向狭槽474,该纵向狭槽可被构造成能够接收远侧切割部分472的近侧端部473。纵向狭槽474和近侧端部473可被设定尺寸并被构造成能够允许该纵向狭槽和该近侧端部之间的相对运动并且可包括滑动接头471。滑动接头471可允许击发驱动装置470的中间部分475移动,以在不移动或至少基本上不移动远侧切割部分472的情况下使端部执行器402进行关节运动。一旦端部执行器402已合适地取向,中间部分475就可朝远侧推进,直到纵向狭槽474的近侧侧壁与近侧端部473发生接触,以便推进远侧切割部分472并击发位于通道498内的钉仓,如下文进一步更详细地描述。主要参见图19,轴框架454可包括限定在其中的纵向狭槽469,该纵向狭槽可被构造成能够滑动地接收关节运动驱动器460,并且类似地,外轴套管的近侧部分428可包括被构造成能够适应上述关节运动驱动器460与轴404的外套管之间的相对移动的纵向开口425。
除上述之外,关节运动锁致动器409可被构造成能够当关节运动锁致动器409处于其近侧解锁位置时将关节运动驱动器460的近侧部分461朝向驱动构件470偏置。更具体地,在至少一个这样的实施方案中,关节运动锁致动器409的内表面可包括凸轮,该凸轮可接合近侧部分461的侧面466并且将近侧部分461偏置成与限定在驱动构件470的中间部分475中的狭槽476接合。当关节运动锁致动器409移回其远侧锁定位置时,关节运动锁致动器409可不再将近侧部分461向内朝向驱动构件470偏置。在至少一个这样的实施方案中,柄部403和/或轴404可包括弹性构件,诸如例如弹簧,该弹性构件可被构造成能够将近侧部分461向外远离击发构件470偏置,使得近侧部分461不与狭槽476可操作地接合,除非当关节运动锁致动器409向近侧移动到其解锁位置时弹性构件的偏置力被关节运动锁致动器409克服,如上所述。在各种情况下,近侧部分461和狭槽476可包括力限制离合器。
一旦端部执行器402已经关节运动成期望的取向,除上述之外,可致动闭合触发器114以使砧座420朝向其闭合位置移动,如图22所示。更具体地,闭合触发器114可向远侧推进轴410的外套管,使得该外套管的远侧部分426可例如向远侧和向下推动砧座420。砧座420可包括从砧座420的相对侧延伸的突出部497,这些突出部可各自被构造成能够在限定在仓通道498中的细长狭槽499内滑动和旋转。砧座420还可包括从其向上延伸的突出部496,该突出部可位于限定在外套管的远侧部分426中的孔495内,其中孔495的侧壁可在远侧部分426向远侧推进时接触突出部496以使砧座420朝向仓通道498移动。除上述之外,闭合驱动装置的致动还可使关节运动锁致动器409从其近侧解锁位置(图20至图22)移动到其远侧锁定位置(图23)。更具体地,闭合驱动装置可被构造成能够向远侧推进闭合驱动装置托架415,该闭合驱动装置托架可接触安装在关节运动致动器409内的衬圈450,如图22所示。如图19和图22所示,衬圈450可包括相对的部分或半部,它们可组装在一起,使得衬圈450的相对部分可包围轴404。衬圈450还可支撑上文讨论的止动器组件452,并且可包括与关节运动锁杆440的近侧端部441接合的安装部分,其也在上文讨论。无论如何,闭合驱动装置托架415可接触衬圈450并且使关节运动锁致动器409向远侧滑动,并且除上述之外,将止动构件457从止动座455(参见图19)移位到止动通道453中,使得关节运动锁致动器409可被推入其锁定位置,并且关节运动锁443可被移动成与近侧锁部分407接合以将端部执行器402锁定就位,如图23所示。此时,闭合驱动装置托架415可防止端部执行器402解锁和进行关节运动,直到闭合驱动装置和砧座420被重新打开并且闭合驱动装置托架415向近侧移动为止,如下文进一步更详细地描述。
现在参见图25,闭合驱动装置的由闭合驱动装置致动器114导致的致动和轴410的外套管428的远侧推进也可使关节运动驱动器460与击发驱动装置470可操作地脱离。在再次查看图20和图21之后,读者将注意到,外套管428包括限定在其中的窗口424,能够旋转的凸轮构件465可定位在该窗口中。凸轮构件465可包括可旋转地销钉或联接到轴框架454的第一端部,和被构造成能够相对于凸轮构件465的销钉端部旋转的第二端部,在其他实施方案中,凸轮构件465可包括任何合适的形状。当外套管428处于其近侧位置并且砧座420处于其打开构型时,凸轮构件465可处于第一位置,该第一位置允许关节运动驱动器460的近侧端部461与限定在击发构件470中的狭槽476接合;然而,当外套管428向远侧推进时,窗口424的侧壁可接合凸轮构件465并且将凸轮构件465的第二端部提升远离轴框架454进入第二位置。在该第二位置,凸轮构件465可移动关节运动驱动器460的近侧端部461远离击发驱动装置470,使得近侧端部461不再位于限定在击发驱动装置470中的狭槽476内。因此,当闭合驱动装置已经被致动以闭合砧座420时,闭合驱动装置可将关节运动锁致动器409推动成其远侧锁定构型,关节运动锁致动器409可将关节运动锁445推动成与端部执行器402的锁定构型,并且另外,闭合驱动装置可使关节运动驱动器460与击发驱动装置470可操作地断开连接。在外科器械400的操作中的此时,击发驱动装置470的致动将不使端部执行器402进行关节运动,并且击发驱动装置470可独立于关节运动驱动器460移动。
现在转到图26,如上所述,击发驱动装置470可向远侧推进以使钉从位于端部执行器402的通道498内的钉仓射出,并且使钉抵靠砧座420变形。如上文所概述,击发驱动装置470还可包括切割构件,该切割构件可被构造成能够横切在端部执行器402内捕获的组织。同样如上所述,柄部403内的电动马达可由击发致动器116操作,以便向远侧推进击发构件470,其中在各种情况下,可操作电动马达直到击发构件470的远侧切割部分472到达钉仓的远侧端部和/或钉仓内的任何其他合适的位置。无论如何,电动马达的旋转可反转以使击发构件470向近侧回缩,如图27所示。在各种情况下,电动马达可使近侧驱动部分482和中间部分475回缩,直到限定在中间部分475中的纵向狭槽474的远侧侧壁与远侧切割构件472的近侧端部473发生接触。此时,近侧驱动部分482和中间部分475的进一步回缩将使远侧切割构件472向近侧回缩。在各种情况下,可操作电动马达,直到限定在击发构件470的中间部分475中的狭槽476与关节运动驱动器460的近侧部分461重新对准;然而,当闭合套管428仍处于向远侧推进的位置时,凸轮构件465仍然可将关节运动驱动器460偏置成与击发构件470脱离接合。为了允许关节运动驱动器460与击发构件470重新接合,在此类情况下,闭合驱动装置将必须重新打开以使限定在外套管部分428中的窗口424与凸轮构件465对准,使得凸轮构件465可朝向轴框架454向内枢转到其第一位置。在各种情况下,关节运动驱动器460可弹性地弯曲成与击发构件470脱离接合,使得当凸轮构件465被允许移回其第一位置时,关节运动驱动器460可朝向轴框架454向内弹性地弯曲,以使关节运动驱动器460的近侧部分461与限定在驱动构件470的中间部分475中的狭槽476重新接合。在各种实施方案中,外科器械400还可包括偏置构件,该偏置构件可被构造成能够将近侧部分461偏置回与中间部分475接合。
读者将注意到,击发构件470的中间部分475在图27中已向近侧回缩,使得限定在中间部分475中的狭槽476相对于关节运动驱动器460的近侧部分461位于近侧。在此类情况下,近侧部分461因此可不可操作地重新连接到击发构件470,直到中间部分475向远侧推进以使狭槽476与近侧部分461对准为止。此类情况可由于中间部分475与击发构件470的切割构件部分472之间由滑动接头471产生的相对滑动而发生,这可以通过例如马上在第一方向上重新致动电动马达来解决。
再次参见图27,击发构件470可处于回缩或重置位置,然而,闭合驱动装置仍然处于致动或闭合构型,这可防止砧座420再次打开并且端部执行器402再次进行关节运动。当闭合驱动装置被释放时,现在参见图28,闭合驱动装置托架415可回缩到近侧位置,在该近侧位置,包括部分426和428的闭合套管也被向近侧拉动。再次参见图19,近侧套管部分428可包括近侧端部417,该近侧端部可与闭合驱动装置托架415接合,使得近端套管部分428和闭合驱动装置托架415在远侧方向和/或近侧方向上一起移动。无论如何,除上述之外,远侧套管部分426的近侧移动可使孔495的远侧侧壁与从砧座420延伸的突出部496接合,以便将砧座420枢转到其打开位置,如图29所示。此外,闭合驱动装置托架415的近侧移动可解锁关节运动锁致动器409,使得关节运动锁致动器409可移动到其近侧解锁位置,因此可向近侧拉动关节运动锁443以压缩弹簧444并且解锁端部执行器402。如上所述,端部执行器402然后可围绕关节运动接头410进行关节运动,并且可重复上述外科器械400的操作。主要参见图18至图20,柄部404还可包括安装到柄部框架480的开关408,该开关可被构造成能够检测关节运动锁致动器409是否处于其近侧解锁位置。在一些实施方案中,开关408可与柄部404中的指示器(诸如例如灯)可操作地联接,该指示器可向外科器械400的操作者指示端部执行器402处于解锁状态并且操作者可利用关节运动开关来例如使端部执行器402进行关节运动。
如上文结合图17的实施方案所述,外科器械400可包括被构造成能够锁定和解锁端部执行器402的关节运动锁系统,和被构造成能够打开和闭合端部执行器402的砧座420的闭合驱动装置。尽管外科器械400的这两个系统在若干方面相互作用,这在上文描述,但这些系统可在其他方面彼此独立地致动。例如,关节运动锁致动器409和端部执行器锁443可在不闭合砧座420的情况下被致动。在外科器械400的该实施方案中,闭合驱动装置独立地操作以闭合砧座420。现在转到图30至图32,外科器械400可包括另选布置,其中闭合驱动装置被致动以:(一)闭合砧座420,和(二)将端部执行器402锁定就位。主要参见图31和图32,轴404可包括关节运动锁杆540,该关节运动锁杆可在近侧解锁位置(图31)和远侧锁定位置(图32)之间移动,在近侧解锁位置,端部执行器402可围绕关节运动接头410进行关节运动,在远侧锁定位置,端部执行器402可锁定就位。类似于关节运动锁杆440,关节运动锁杆540可包括与关节运动锁443可操作地接合的远侧端部542,使得当向近侧拉动关节运动锁杆540时,可向近侧拉动关节运动锁443。类似地,当向远侧推动关节运动锁杆540时,可向远侧推动关节运动锁443。与被关节运动锁致动器409向远侧推动和向近侧拉动的关节运动锁杆440相比,如上所述,关节运动锁杆540可被闭合套管428向远侧推动和向近侧拉动。更具体地,关节运动锁杆540的近侧端部541可包括钩547,当闭合套管428被向近侧拉动时,该钩可扣住闭合套管428的一部分并且和闭合套管428一起被向近侧拉动。在此类情况下,套管428可将关节运动锁杆540拉到解锁状态。如读者将注意到的,闭合套管428可包括窗口549,关节运动锁杆540的近侧端部541可定位在该窗口内。当闭合套管428被向远侧推动时,除上述之外,窗口549的近侧侧壁548可接触近侧端部541并且向远侧推动关节运动锁杆540和关节运动锁443,以便将端部执行器402锁定就位。
如本文所述,可能期望采用可包括能够重复使用的部分的外科系统和装置,这些能够重复使用的部分被构造成能够与可互换外科部件一起使用。参见图33,例如,示出了通常指定为1000的至少一种形式的外科系统,该外科系统包括可以或不可以重复使用的外科器械1010。外科器械1010可与多个可互换轴组件1200、1200’、1200”一起采用。可互换轴组件1200、1200’、1200”可具有可操作地与其联接的外科端部执行器1300、1300’、1300”,该外科端部执行器被构造成能够执行一种或多种外科任务或手术。例如,外科端部执行器1300、1300'、1300”中的每一者可包括外科切割和紧固装置,该外科切割和紧固装置被构造成能够将外科钉仓可操作地支撑在其中。轴组件中的每个轴组件可采用端部执行器,这些端部执行器适于支持不同尺寸和类型的钉仓,具有不同的轴长度、尺寸和类型等。虽然本发明的附图示出了被构造成能够切割和缝合组织的端部执行器,但是外科系统1000的各个方面也可有效地与被构造成能够向用于各种外科应用和手术中的可互换轴安装的端部执行器布置施加其他运动和能量形式(诸如例如射频(RF)能量、超声能量和/或运动)的外科器械一起采用。此外,该端部执行器、轴组件、柄部、外科器械和/或外科器械系统可利用任意合适的紧固件来紧固组织。例如,包括可移除地被存储在其中的多个紧固件的紧固件仓能够可移除地插入轴组件的端部执行器中和/或附接到轴组件的端部执行器。在各种情况下,可选择轴组件以附接到外科器械的柄部,并且可选择紧固件仓以附接到轴组件。
图33所示的外科器械1010包括外壳1040,该外壳由被构造成能够被临床医生抓持、操纵和致动的柄部1042组成。继续参阅本具体实施方式,然而应当理解,本文公开的各种形式的可互换轴组件的各种独特且新型的布置也可以有效地与机器人控制的外科系统结合使用。因此,术语“外壳”也可涵盖机器人系统的容纳或以其他方式可操作地支撑至少一个驱动系统的外壳或类似部分,所述至少一个驱动系统被构造成能够生成并施加可用于致动本文所公开的可互换轴组件及其相应的等同物的至少一种控制动作。术语“框架”可指手持式外科器械的一部分。术语“框架”还可表示机器人控制的外科器械的一部分和/或机器人系统的可用于可操作地控制外科器械的一部分。例如,本文所公开的可互换轴组件可与美国专利申请公布2012/0298719中公开的各种机器人系统、器械、部件和方法一起采用。名称为“SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENTARRANGEMENTS”的美国专利申请序列号13/118,241(现为美国专利申请公布2012/0298719)全文以引用方式并入本文。
图34示出了可互换轴组件1200可操作地与之联接的外科器械1010。在所示形式中,该外科器械包括柄部1042。在至少一种形式中,柄部1042可包括一对能够互连的外壳段1044、1046,这些外壳段可通过螺钉、卡扣特征、粘合剂等互连。参见图35。在所示的布置中,柄部外壳段1044、1046配合以形成可由临床医生抓握和操纵的手枪式握持部1048。如将在下文进一步详细地讨论,柄部1042可操作地支撑其中的多个驱动系统,这些驱动系统被配置为生成各种控制动作并将这些控制动作施加到可操作地与其附接的可互换轴组件的对应部分。
柄部1042还可包括可操作地支撑多个驱动系统的框架1080。例如,框架1080可操作地支撑通常被标记为1050的第一或闭合驱动系统,该第一或闭合驱动系统可用于将闭合动作和打开动作施加到可操作地附接或联接的可互换轴组件1200。在至少一种形式中,闭合驱动系统1050可包括被框架1080枢转地支撑的闭合触发器1052形式的致动器。更具体地,如图35所示,闭合触发器1052可被框架1080能够枢转地支撑,使得当临床医生抓握柄部1042的手枪式握持部1048时,闭合触发器1052可被轻易地从起始或未致动位置枢转到致动位置,并且更具体地,枢转到完全压缩或完全致动位置。闭合触发器1052可由弹簧或其他偏置布置结构(未示出)偏置到未致动位置。在各种形式中,闭合驱动系统1050还包括枢转地联接到闭合触发器1052的闭合连杆组件1060。如图35中可见,闭合连杆组件1060可包括闭合触发器1052,该闭合触发器能够枢转地联接到闭合连接件1064,该闭合连接件具有从其突出的一对横向延伸的附接凸耳或部分1066。闭合连接件1064在本文中也可称为“附接构件”。
仍参见图35,可观察到,闭合触发器1052可在其上具有锁定壁1068,该锁定壁被构造成能够与枢转地联接到框架1080的闭合释放组件1070配合。在至少一种形式中,闭合释放组件1070可包括释放按钮组件1072,该释放按钮组件具有形成于其上的朝远侧突出的凸轮从动臂1074。释放按钮组件1072可被释放弹簧1076沿逆时针方向枢转。临床医生将闭合触发器1052从其未致动位置朝向柄部1042的手枪式握持部1048压下时,闭合连接件1062向上枢转至某个点,其中凸轮从动臂1072落入该点中以与闭合连接件1062上的锁定壁1068保持接合,从而阻止闭合触发器1052返回未致动位置。因此,闭合释放组件1070用来将闭合触发器1052锁定在完全致动位置。当临床医生期望将闭合触发器1052解锁以允许其被偏置到未致动位置时,临床医生只需枢转闭合释放按钮组件1072,使得凸轮从动臂1074运动成与闭合触发器1052上的锁定壁1068脱离接合。当凸轮从动臂1074已移动成与闭合触发器1052脱离接合时,闭合触发器1052可枢转回到未致动位置。也可采用其他闭合触发器锁定布置结构和释放布置结构。
在至少一种形式中,柄部1042和框架1080可操作地支撑在本文中被称为击发驱动系统1100的另一个驱动系统,该驱动系统被配置成能够向附接到其的可互换轴组件的对应部分施加击发动作。击发驱动系统在本文中也可被称为“第二驱动系统”。击发驱动系统1100可以采用定位在柄部1042的手枪式握持部1048中的电动马达1102。在各种形式中,马达1102可为具有例如约25,000RPM的最大转速的DC有刷驱动马达。在其他布置结构中,马达可包括无刷马达、无绳马达、同步马达、步进马达、或任何其他合适的电动马达。电池1104(即“电源”或“电源组”)诸如锂离子电池可联接到柄部1042,以向控制电路板组件1106并最终向马达1102提供电力。图34示出了电池组外壳1104,该电池组外壳被构造成能够可释放地安装到柄部1042以用于将控制电力供应给外科器械1010。串联连接的多个电池单元可用作电源以向马达供电。此外,电源可为可替换的和/或可充电的。
如上文相对于其他各种形式所概述,电动马达1102可包括与齿轮减速器组件1108可操作地介接的可旋转轴(未示出),该齿轮减速器组件与一组或一齿条的驱动齿1112啮合接合地安装在可纵向运动的驱动构件1110上。在使用中,电池所提供的电压极性可沿顺时针方向操作电动马达1102,其中由电池施加到电动马达的电压极性可被反转,以便沿逆时针方向操作电动马达1102。当电动马达1102在一个方向上旋转时,驱动构件1110将在远侧方向“D”上被轴向地驱动。当马达1102在相反的旋转方向上被驱动时,驱动构件1110将在近侧方向“P”上被轴向地驱动。参见例如图35。柄部1042可包括开关,该开关可被构造成能够使由电池施加到电动马达1102的极性反转。与本文所述的其他形式一样,柄部1042还可包括传感器,该传感器被配置成检测驱动构件1110的位置和/或驱动构件1110正在运动的方向。
马达1102的致动可通过被枢转地支撑在柄部1042上的击发触发器1120来控制。击发触发器1120可在未致动位置与致动位置之间枢转。击发触发器1120可被弹簧(未示出)或其他偏置构造偏置到未致动位置,使得当临床医生释放击发触发器1120时,其可被弹簧或偏置构造枢转到或以其他方式返回到未致动位置。在至少一种形式中,击发触发器1120可定位在闭合触发器1052的“外侧”,如上文所讨论。在至少一种形式中,击发触发器安全按钮1122可以枢转地安装到闭合触发器1052。例如,如图35和图36中可见,安全按钮1122可定位在击发触发器1120和闭合触发器1052之间,并具有从其突出的枢转臂1124。如图38所示,当闭合触发器1052处于未致动位置时,安全按钮1122被容纳在柄部外壳中,此时临床医生可能无法轻易触及该按钮,也无法使该按钮在防止对击发触发器1120致动的安全位置与击发触发器1120可被击发的击发位置之间运动。临床医生压下闭合触发器1052时,安全按钮1122和击发触发器1120向下枢转,随后可被临床医生操纵。
如上所述,在至少一种形式中,可纵向移动的驱动构件1110具有形成在其上的一齿条的齿1112,以用于与齿轮减速器组件1108的对应驱动齿轮1114啮合接合。至少一种形式还包括可手动致动的“应急”组件1130,该组件被构造成能够使得临床医生能够在马达被禁用的情况下手动地使可纵向移动的驱动构件1110回缩。应急组件1130可包括杠杆或应急柄部组件1132,该杠杆或应急柄部组件被构造成能够被手动地枢转成与驱动构件1110中的齿1112棘轮接合。因此,临床医生可通过使用应急柄部组件1132来手动地回缩驱动构件1110,以使驱动构件在近侧方向“P”上做棘轮运动。美国专利申请公布U.S.2010/0089970(现为美国专利8,608,045)公开了应急布置和也可与本文所公开的各种器械一起使用的其他部件、布置和系统。名称为“POWERED SURGICAL CUTTING AND STAPLING APPARATUS WITHMANUALLY RETRACTABLE FIRING SYSTEM”的美国专利申请序列号12/249,117(现为美国专利申请公布2010/0089970,现为美国专利8,608,045)全文以引用方式并入。
图34和图37示出了可互换轴组件1200的一种形式,其具有例如能够操作地与其附接的外科端部执行器1300。这些图中所示的端部执行器1300可被构造成能够采用本文所公开的各种方式来切割和缝合组织。例如,端部执行器1300可包括被构造成能够支撑外科钉仓1304的通道1302。钉仓1304可包括可移除的钉仓1304,使得它可在被用掉时更换。然而,在其他布置中,钉仓可被构造成使得一旦安装在通道1302内,就不旨在从该通道移除。通道1032和钉仓1304可统称为端部执行器1300的“第一钳口部分”。在各种形式中,端部执行器1300可具有砧座1310形式的“第二钳口部分”,其以本文所论述的各种方式能够移动地或枢转地支撑在通道1302上。
可互换轴组件1200还可包括轴1210,该轴包括联接到轴附接模块或轴附接部分1220的轴框架1212。在至少一种形式中,轴框架1212的近侧端部1214可延伸穿过形成在轴附接模块1220上并且可旋转地与其附接的中空衬圈部分1222。例如,环形沟槽1216可设置在轴框架1212的近侧端部1214中,用于与U形保持器1226接合,该U形保持器延伸穿过轴附接模块1220中的狭槽1224。这种布置使得轴框架1212能够相对于轴附接模块1220旋转。
轴组件1200还可包括中空外套管或闭合管1250,轴框架1212延伸穿过该中空外套管或闭合管。外套管1250在本文中也可被称为“第一轴”和/或“第一轴组件”。外套管1250具有适于可旋转地联接到闭合管附接轭1260的近侧端部1252。如图37中可见,外套管1250的近侧端部1252被构造成能够被接收在闭合管附接轭1260中的支架1262内。U形连接器1266延伸穿过闭合管附接轭1260中的狭槽1264,以被接收在外套管1250的近侧端部1252中的环形沟槽1254中。这种布置用于将外套管1250可旋转地联接到闭合管附接轭1260,使得外套管1250可相对于该闭合管附接轭旋转。
如图38和39中可见,轴框架1214的近侧端部1214从外套管1250的近侧端部1252向近侧突出,并且由U形保持器1226(图38中示出)可旋转地联接到轴附接模块1220。闭合管附接轭1260被构造成能够滑动地接收在轴附接模块1220中的通道1268内。这种布置允许外套管1250相对于轴附接模块1220在轴框架1212上在近侧方向“P”和远侧方向“D”上轴向移动,如将在下文进一步详细讨论的。
在至少一种形式中,可互换轴组件1200还可包括关节运动接头1350。然而,其他可互换轴组件可能无法进行关节运动。如在图37中可见,例如,关节运动接头1350包括双枢轴闭合套管组件1352。根据各种形式,双枢轴闭合套管组件1352包括具有朝远侧突出的上柄脚1356和下柄脚1358的轴闭合套管组件1354。端部执行器闭合套管组件1354包括用于接合砧座1310上的打开插片的马蹄形孔1360和插片1362。如上所述,当砧座1310打开时,马蹄形孔1360和插片1362接合砧座插片。上部双枢轴连接件1364包括向上突出的远侧枢轴销和近侧枢轴销,这些枢轴销分别接合外套管1250上的朝近侧突出的上柄脚1356中的上部远侧销孔以及朝远侧突出的上柄脚1256中的上部近侧销孔。下部双枢轴连接件1366包括向下突出的远侧枢轴销和近侧枢轴销,这些枢轴销分别接合朝近侧突出的下柄脚1358中的下部远侧销孔以及朝远侧突出的下柄脚1258中的下部近侧销孔。
在使用中,闭合套管组件1354朝远侧(方向“D”)平移,以例如响应于闭合触发器1052的致动来将砧座1310闭合。通过向远侧平移外套管1250并且因此向远侧平移轴闭合套管组件1354,使其以上述方式撞击砧座1310上的近侧表面,由此使砧座1310闭合。同样如上所述,通过朝近侧平移外套管1250和轴闭合套管组件1354,致使插片1362和马蹄形孔1360接触并推压砧座插片以将砧座1310抬起,由此打开砧座1310。在砧座打开位置,轴闭合套管组件1352移动至其近侧位置。
在至少一种形式中,可互换轴组件1200还包括击发构件1270,该击发构件被支撑以便在轴框架1212内轴向行进。击发构件1270包括被构造用于附接到远侧切割部分1280的中间击发轴部分1272。击发构件1270在本文中也可被称为“第二轴”和/或“第二轴组件”。如图37中可看到的那样,中间击发轴部分1272可包括其远侧端部中的纵向狭槽1274,该纵向狭槽可被构造成能够接收远侧切割部分1280的近侧端部1282。纵向狭槽1274和近侧端部1282可被设定尺寸并被构造成能够允许该纵向狭槽和该近侧端部之间的相对运动并且可包括滑动接头1276。滑动接头1276可允许击发驱动装置1270的中间击发轴部分1272移动,以在不移动或至少基本上不移动远侧切割部分1280的情况下使端部执行器1300进行关节运动。一旦端部执行器1300已合适地取向,中间击发轴部分1272就可朝远侧推进,直到纵向狭槽1272的近侧侧壁与近侧端部1282发生接触,以便推进远侧切割部分1280并击发位于通道1302内的钉仓,如本文所述。如图37中可进一步看到的那样,轴框架1212在其中具有细长的开口或窗口1213,以利于将中间击发轴部分1272组装和插入到轴框架1212中。一旦中间击发轴部分1272已插入到其中,则顶部框架片段1215可与轴框架1212接合,以将中间击发轴部分1272和远侧切割部分1280包封在其中。读者还将注意到,关节运动接头1350还可包括引导件1368,该引导件可被构造成能够将击发构件1270的远侧切割部分1280接收在其中,并且当远侧切割部分1280在关节运动接头1350内和/或相对于该关节运动接头向远侧推进和/或向近侧回缩时引导该远侧切割部分。
如图37中可见,轴附接模块1220还可包括闩锁致动器组件1230,该闩锁致动器组件可通过有头螺钉(未示出)或其他合适的紧固件可移除地附接到轴附接模块。闩锁致动器组件1230被构造成能够与锁定轭1240配合,该锁定轭枢转地联接到轴附接模块1220以相对于轴附接模块选择性地枢转行进。参见图41。参见图39,锁定轭1240可包括两个朝近侧突出的锁凸耳1242(图37),这两个锁凸耳被构造用于与框架1080的框架附接模块部分1084中形成的对应锁止动器或沟槽1086能够释放地接合。锁定轭1240基本上是U形的,并且在闩锁致动器组件1230已经联接到轴附接模块1220之后安装在闩锁致动器组件1230上方。闩锁致动器组件1230可具有弓形主体部分1234,该弓形主体部分为锁定轭1240提供足够的间隙以使其相对于弓形主体部分在闩锁位置与未闩锁位置之间枢转。
在各种形式中,锁定轭1240被弹簧或偏置构件(未示出)沿近侧方向偏压。换句话说,锁定轭1240被偏置到闩锁位置(图40),并且可被能够移动地支撑在闩锁致动器组件1230上的闩锁按钮1236枢转到未闩锁位置(图41)。例如,在至少一种布置中,闩锁按钮1236能够滑动地保持在闩锁外壳部分1235内,并且被闩锁弹簧或偏置构件(未示出)在近侧方向“P”上偏置。如下面将进一步详细讨论的,闩锁按钮1236具有朝远侧突出的释放凸耳1237,该释放凸耳被设计成接合锁定轭1240并且在闩锁按钮1236致动时将该锁定轭从闩锁位置枢转到图41所示的未闩锁位置。
可互换轴组件1200还可包括可旋转地支撑在轴附接模块1220上的喷嘴组件1290。在至少一种形式中,例如,喷嘴组件1290可由两个喷嘴半部或部分1292、1294构成,所述两个喷嘴半部或部分可通过螺钉、卡扣特征、粘合剂等互连。当安装在轴附接模块1220上时,喷嘴组件1290可与外套管1250和轴框架1212介接,以使临床医生能够选择性地使轴1210相对于轴附接模块1220围绕轴轴线SA-SA旋转,该轴轴线SA-SA可例如由击发构件组件1270的轴线限定。特别地,喷嘴组件1290的一部分可延伸穿过外套管中的窗口1253以接合轴框架1212中的凹口1218。参见图37。因此,喷嘴组件1290的旋转将导致轴框架1212和外套管1250相对于轴附接模块1220围绕轴线A-A旋转。
现在参见图42和图43,读者将观察到框架1080的框架附接模块部分1084形成为具有两个面向内的燕尾形接收狭槽1088。每个燕尾接收狭槽1088可为锥形的,或换句话讲,是略微V形的。参见例如图36和图38(仅示出了狭槽1088中的一个狭槽)。燕尾形接收狭槽1088被构造成能够可释放地接收轴附接模块1220的向近侧延伸的连接器部分1228的对应锥形附接或凸耳部分1229。如可在图37至图39中进一步所见,轴附接凸耳1278形成在中间击发轴1272的近侧端部1277上。如将在下文进一步详细地讨论,当可互换轴组件1200联接到柄部1042时,轴附接凸耳1278被接收在形成于纵向驱动构件1110的远侧端部1111中的击发轴附接支架1113中。另外,闭合管附接轭1260包括向近侧延伸的轭部分1265,该轭部分包括向下打开以捕获闭合附接杆1064上的附接凸耳1066的两个捕获狭槽1267。
现在将参照图44至图48描述可互换轴组件1220与柄部1042附接的操作。在各种形式中,框架1080或驱动系统中的至少一个限定致动轴线AA-AA。例如,致动轴线AA-AA可由可纵向移动的驱动构件1110的轴线限定。因此,当中间击发轴1272可操作地联接到可纵向移动的驱动构件1110时,致动轴线AA-AA与轴轴线SA-SA同轴,如图48所示。
要开始联接过程,临床医生可将可互换轴组件1200的轴附接模块1220定位在框架1080的框架附接模块部分1084上方或附近,使得形成在轴附接模块1220的连接器部分1228上的附接凸耳1229与附接模块部分1084中的燕尾形狭槽1088对准,如图45所示。然后临床医生可使轴附接模块1220沿着基本上横向于致动轴线AA-AA的安装轴线IA-IA移动。换句话说,轴附接模块1220在基本上横向于致动轴线AA-AA的安装方向“ID”上移动,直到连接器部分1228的附接凸耳1229安置成与对应的燕尾形接收狭槽1088“能够操作地接合”。参见图44和图46。图47示出了在中间击发轴1272上的轴附接凸耳1278进入可纵向移动的驱动构件1110中的支架1113以及闭合附接杆1064上的附接凸耳1066进入闭合管附接轭1260的轭部分1265中的对应狭槽1267之前轴附接模块1220的位置。图48示出了在附接过程已经完成之后轴附接模块1220的位置。如在该图中可以看出,凸耳1066(仅示出一个凸耳)安置成在闭合管附接轭1260的轭部分1265中其相应的狭槽1267中能够操作地接合。如本文所用,术语“可操作地接合”在两个部件的背景下是指这两个部件彼此充分地接合,使得一旦向其施加致动动作,这些部件便可执行其预期行动、功能和/或程序。
如上文所讨论,再次参见图44至图49,可互换轴组件1200的至少五个系统可与柄部1042的至少五个对应系统可操作地联接。第一系统可包括框架系统,该框架系统将轴组件1200的框架与柄部1042的框架联接和/或对准。如上文所概述,轴组件1200的连接器部分1228可与柄部框架1080的附接模块部分1084接合。第二系统可包括闭合驱动系统,该闭合驱动系统可将柄部1042的闭合触发器1052与轴组件1200的闭合管1250和砧座1310可操作地连接。如上文所概述,轴组件1200的闭合管附接轭1260可与柄部1042的附接凸耳1066接合。第三系统可包括击发驱动系统,该击发驱动系统可将柄部1042的击发触发器1120与轴组件1200的中间击发轴1272可操作地连接。如上文所概述,轴附接凸耳1278可与纵向驱动构件1110的支架1113可操作地连接。第四系统可包括电气系统,该电气系统能够:(一)发送信号到柄部1042中的控制器(诸如例如微控制器7004)以表明轴组件(诸如例如轴组件1200)已与柄部1042可操作地接合,并且/或者(二)在轴组件1200与柄部1042之间传导功率和/或传送信号。例如,轴组件1200可包括六个电触点,并且电连接器4000也可包括六个电触点,其中当轴组件1200组装到柄部1042时,轴组件1200上的每个电触点与电连接器4000上的电触点组对并配对。轴组件1200还可包括闩锁1236,该闩锁可以是第五系统诸如锁系统的一部分,该锁系统将可轴组件1200可释放地锁到柄部1042。在各种情况下,例如当闩锁1236与柄部1042接合时,闩锁1236可将柄部1042中的电路闭合。
除上述之外,轴组件1200的框架系统、闭合驱动系统、击发驱动系统和电气系统可在横向方向上(即沿着轴线IA-IA)组装到柄部1042的对应系统。在各种情况下,轴组件1200的框架系统、闭合驱动系统和击发驱动系统可同时联接到柄部1042的对应系统。在某些情况下,轴组件1200的框架系统、闭合驱动系统和击发驱动系统中的两者可同时联接到柄部1042的对应系统。在至少一种情况下,框架系统可至少最初在闭合驱动系统和击发驱动系统联接之前联接。在此类情况下,框架系统可被构造成能够在闭合驱动系统和击发驱动系统如上所概述的联接之前使它们的对应部件对准。在各种情况下,外壳组件1200和柄部1042的电气系统部分可被构造成能够同时联接,使得框架系统、闭合驱动系统和/或击发驱动系统最终或完全安置。在某些情况下,外壳组件1200和柄部1042的电气系统部分可被构造成能够在框架系统、闭合驱动系统和/或击发驱动系统最终或完全安置之前联接。在一些情况下,外壳组件1200和柄部1042的电气系统部分可被构造成能够在框架系统已经至少部分地联接之后但在闭合驱动系统和/或击发驱动系统已经联接之前联接。在各种情况下,锁定系统可被构造成使得它是待接合的最后一个系统,即在框架系统、闭合驱动系统、击发驱动系统和电气系统全都已经接合之后才接合。
如上文所概述,再次参见图44至图49,柄部1042的电连接器4000可包括多个电触点。现在转到图51,电连接器4000可包括例如第一触点4001a、第二触点4001b、第三触点4001c、第四触点4001d、第五触点4001e和第六触点4001f。尽管所示的实施方案利用了六个触点,但设想了可利用多于六个触点或少于六个触点的其他实施方案。如图51所示,第一触点4001a可与晶体管4008电连通,触点4001b至4001e可与微控制器7004电连通,第六触点4001f可与地面电连通。微控制器7004在下文中更详细地讨论。在某些情况下,电触点4001b至4001e中的一个或多个可与微控制器7004的一个或多个输出通道电连通,并且在柄部1042处于加电状态时可通电,或具有施加到其上的电压电位。在一些情况下,电触点4001b至4001e中的一个或多个可与微控制器7004的一个或多个输入通道电连通,并且微控制器7004可被配置为在柄部1042处于加电状态时,检测电压电位何时被施加到此类电触点。当轴组件(诸如轴组件1200)组装到柄部1042时,电触点4001a至4001f可能不彼此连通。然而,当轴组件未组装到柄部1042时,电连接器4000的电触点4001a至4001f可能暴露,而且在一些情况下,触点4001a至4001f中的一个或多个可能意外地彼此电连通。例如,当触点4001a至4001f中的一个或多个接触到导电材料时,可能出现此类情况。当发生这种情况时,例如,微控制器7004可接收到错误的输入并且/或者轴组件1200可接收到错误的输出。为解决这个问题,在各种情况下,当轴组件(诸如轴组件1200)未附接到柄部1042时,柄部1042可以不加电。在其他情况下,柄部1042在轴组件(诸如轴组件1200)未附接到其上时可以加电。在这种情况下,例如,微控制器7004可被构造成能够在轴组件附接到柄部1042之前忽视施加到与微控制器7004电连通的触点(即,触点4001b至4001e)的输入或电压电位。虽然在这种情况下微控制器7004可被供电以操作柄部1042的其他功能,但柄部1042可处于掉电状态。在某种程度上,如果施加到电触点4001b至4001e的电压电位可以不影响对柄部1042的操作,则电连接器4000可处于掉电状态。读者将会知道,即使触点4001b至4001e可处于掉电状态,但未与微控制器7004电连通的电触点4001a和4001f可处于、也可不处于掉电状态。例如,无论柄部1042是处于加电状态还是掉电状态,第六触电4001f都可保持与地面电连通。此外,无论柄部1042是处于加电还是掉电状态,晶体管4008和/或晶体管(诸如晶体管4010)的任何其他合适结构和/或开关可被构造成能够控制从柄部1042内的电源4004(诸如例如电池1104)到第一电触点4001a的电力供应,如上所概述。在各种情况下,例如,轴组件1200的闩锁1236可被构造成能够当闩锁1236与柄部1042接合时改变晶体管4008的状态。在各种情况下,如本文其他地方所述,闩锁1236可被构造成能够在接合柄部1042时关闭电路,并且因此影响晶体管4008的状态。在某些情况下,除下述之外,霍尔效应传感器4002可被构造成能够转换晶体管4010的状态,因此可转换晶体管4008的状态,最终将来自功率源4004的功率供应给第一触点4001a。这样,除上述之外,联接到连接器4000的功率电路和信号电路两者当轴组件未安装到柄部1042时可被掉电,并且当轴组件安装到柄部1042时可被加电。
在各种情况下,再次参见图51,柄部1042可包括例如霍尔效应传感器4002,当轴组件联接到柄部1042时,该霍尔效应传感器可被构造成能够检测位于该轴组件(诸如例如轴组件1200)上的可检测元件,诸如磁性元件。霍尔效应传感器4002可由诸如电池之类的功率源4006供电,该功率源实际上可放大霍尔效应传感器4002的检测信号,并经由图51所示的电路与微控制器7004的输入通道连通。一旦微控制器7004接收到指示轴组件已至少部分地联接到柄部1042、因而电触点4001a至4001f不再暴露的输入,微控制器7004就可进入其正常的或加电的操作状态。在此类工作状态中,微控制器7004将对从轴组件传输至一个或多个触点4001b-4001e的信号进行评估,和/或通过处于其正常使用状态的一个或多个触点4001b-4001e将信号传输至轴组件。在各种情况下,可能必须使轴组件1200完全安置,才能使霍尔效应传感器4002检测到磁性元件。例如,虽然可利用霍尔效应传感器4002来检测轴组件1200是否存在,但也可利用传感器和/或开关的任何合适的系统来检测轴组件是否已组装到柄部1042。这样,除上述之外,联接到连接器4000的功率电路和信号电路两者当轴组件未安装到柄部1042时可被掉电,并且当轴组件安装到柄部1042时可被加电。
在各种实施方案中,例如,可采用任何数量的磁感测元件来检测轴组件是否已装配到柄部1042。例如,用于磁场感测的技术包括探测线圈、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传感器等。
在可互换轴组件1200已经能够操作地联接到柄部1042之后,闭合触发器1052的致动将导致外套管1250和与其联接的轴闭合套管组件1354向远侧轴向推进,以使砧座1310以本文所公开的各种方式致动。如图48中还可以看出,可互换轴组件1200中的击发构件1270联接到柄部1042中的可纵向移动的驱动构件1110。更具体地,形成在中间击发轴1272的近侧端部1277上的轴附接凸耳1278被接收在形成在可纵向移动的驱动构件1110的远侧端部1111中的击发轴附接支架1113内。因此,击发触发器1120的导致向马达1102供电以使可纵向移动的驱动构件1110轴向推进的致动还将使得击发构件1270在轴框架1212内轴向移动。这种动作将导致远侧切割部分1280以本文所公开的各种方式穿过在端部执行器1300中夹紧的组织而推进。尽管在图48中未观察到,但是本领域的普通技术人员还将理解,当处于该图中所示的联接位置时,轴附接模块1220的附接凸耳部分1229安置在框架1080的附接模块部分1084中其相应燕尾形接收狭槽1088内。因此,轴附接模块1220联接到框架1080。另外,尽管图48中未示出(但是在图40中可以看出),当轴附接模块1220已经联接到框架1080时,锁定轭1240上的锁定凸耳1242安置在框架1080的附接模块部分1084中其相应的锁定沟槽1086内(图40中仅示出一个)以可释放地保持轴附接模块1220与框架1080的所联接的能够操作的接合。
为了将可互换轴组件1220与框架1080分离,临床医生在远侧方向“D”上推动闩锁按钮1236,以使锁定轭1240枢转,如图41所示。锁定轭1240的这种枢转运动使得它上面的锁定凸耳1242脱离与锁定凹槽1086保持接合的状态。然后临床医生可使轴附接模块1220在断开方向“DD”上移动远离柄部,如图49所示。
本领域普通技术人员将理解,轴附接模块1220还可保持静止并且柄部1042沿基本上横向于轴轴线SA-SA的安装轴线IA-IA移动,以使连接器部分1228上的凸耳1229安置成与燕尾形狭槽1088接合。还应当理解,轴附接模块1220和柄部1042可沿基本上横向于轴轴线SA-SA和致动轴线AA-AA的安装轴线IA-IA同时朝向彼此移动。
如本文所用,短语“基本上横向于致动轴线和/或轴轴线”是指几乎垂直于致动轴线和/或轴轴线的方向。然而,应当理解,有些偏离垂直于致动轴线和/或轴轴线的方向也基本上横向于这些轴线。
使用本文所公开的器械的物理特性,现在转向图52和图53,控制器(诸如例如微控制器7004)可被设计成模拟器械的实际系统在控制器的软件中的响应。将所模拟响应与实际系统的(嘈杂离散)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,其可检测对系统的外部影响。参见图52和图53,可按照或接近目标速率(或速度)移动轴组件1200的端部执行器1300中的击发元件,或切割元件。可利用图52和图53中所公开的系统以目标速率移动切割元件。系统可包括反馈控制器4200,其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、LQR和/或自适应控制器。系统还可包括电源。电源可将来自反馈控制器4200的信号转换为例如系统的物理输入,在这种情况下为电压。其它示例包括但不限于例如脉宽调制(PWM)电压、频率调制电压、电流、扭矩和/或力。
继续参见图52和图53,其中提到的物理系统为器械的被构造成能够驱动击发构件或切割构件的实际驱动系统。一个实例为有刷直流马达,其具有齿轮箱以及至关节运动和/或刀系统的机械链接。另一个示例为本文所公开的马达1102,其操作例如可互换轴组件的击发构件10060和关节运动驱动器10030。图52和图53中提到的外部影响4201(例如)为事物(比如组织、周围物体和摩擦)对物理系统的未测量的、不可预测的影响。此类外部影响可称为阻力并且可例如由马达4202表示,该马达与马达1102行为相反。在各种情况下,外部影响(诸如阻力)为物理系统的模拟偏离实际物理系统的主要原因。图52和图53中示出的以及下文进一步描绘的系统可解决击发构件或切割构件的预测行为与击发构件或切割构件的实际行为之间的差异。
继续参见图52和图53,其中提到的离散传感器对实际物理系统的物理参数进行测量。这种离散传感器的一个实施方案可包括本文所述的绝对定位传感器7102和系统。由于此类离散传感器的输出可为数字信号(或连接至数字数据采集系统),其输出可具有有限的分辨率和取样频率。可向微控制器(诸如例如微控制器7004)提供离散传感器的输出。在各种情况下,该微控制器可将所模拟或所估计响应与所测量响应合并。在某些情况下,可能有用的是使用足够所测量响应以确保将外部影响考虑在内,而不使观察到的响应无用地嘈杂。执行该操作的算法的实例包括加权平均数和/或理论控制回路,其例如朝所测量响应驱动所模拟响应。最终,除上述之外,物理系统的模拟将例如质量、惰性、粘性摩擦和/或电感电阻之类的特性考虑在内,以通过得知输入预测物理系统的状态和输出。图53示出了另外的对操作实际系统所提供的电流进行评估和测量,其为又一个参数,可对该参数进行评估以用于控制例如轴组件1200的切割构件或击发构件的速度。在某些情况下,除了测量电压之外或代替测量电压,通过测量电流,可使物理系统更精确。尽管如此,本文所公开的想法可延伸为其它物理系统的其它状态参数的测量。
可利用控制系统诸如例如图54和/或图57所示的控制系统来控制本文所公开的任何外科器械。在各种情况下,控制系统可包括微控制器,诸如例如微控制器7004,该微控制器可被配置为操作外科器械的各种系统。除上述之外,控制系统可包括用于检测轴组件诸如例如轴组件1200是否已经组装或至少部分地组装到柄部1042的组装检测装置。此类组件检测装置可包括例如上文所述的霍尔效应传感器4002,以及在轴组件未组装到柄部1042的情况下用于使柄部1042保持处于掉电状态的装置,和在轴组件被组装到柄部1042的情况下用于使柄部1042保持处于加电状态的装置(除上述之外)。如上文所概述,例如微控制器7004可包括此类装置。控制系统还可包括用于将电力传送到轴组件和/或从轴组件传送电力的电力传送装置,和/或用于将通信信号传送到轴组件和/或从轴组件传送通信信号的信号通信装置。此类电力传送装置和信号通信装置可包括例如电连接器4000、轴组件上的对应电连接器和/或微控制器7004。
进一步参见图54和图57,控制系统还可包括至少一个闭合触发器开关和至少一个闭合触发器电路,它们可被配置为向微控制器7004传送触发器1052已关闭和/或由微控制器7004向其解释该触发器已关闭。各种开关可包括例如电位计和/或霍尔效应传感器。控制系统还可包括用于在闭合触发器1052处于未闭合位置时使外科器械以未闭合操作状态操作的未闭合操作装置,和用于在闭合触发器1052处于闭合位置时使外科器械以闭合操作状态操作的闭合操作装置。控制系统可包括电源诸如例如电池1104,和用于在整个控制系统中分配该电源的电力的装置。控制系统可包括马达(诸如例如马达1102)、马达电源开关(诸如例如击发触发器1120),和用于使马达1102以期望的方式操作的马达操作装置,如本文其他地方所述。在某些情况下,此类马达操作装置可被配置为例如利用脉冲宽度调制(PWM)电压控制来控制马达1102。此外,PWM电压控制可用于控制例如击发构件1272和1280的速度。在外科器械的未闭合操作状态中,在一些情况下,电池1104可与马达1102断开连写,而在某些情况下,马达控制器可被配置为直到微控制器7004检测到闭合触发器1052的闭合之前都阻止马达1102的操作,即使可向马达1102供应电力。在此类情况下,微控制器7004然后可使外科器械在其闭合操作状态下操作。在闭合操作状态下,电力可被供应到马达1102,并且马达控制器可被配置为响应于击发触发器1120的操作来操作马达1102。图58至图60示出了用于操作例如马达1102和击发构件1272和1280的各种操作。
进一步参见图54和图57,控制系统可包括例如12位磁性旋转编码器,并且可被配置为监测击发构件1272和1280的位置。在各种情况下,控制系统可包括绝对定位传感器7102和上述感测系统以监测击发构件1272和1280的位置。控制系统还可包括用于手动移动击发构件1272和1280的手动驱动装置,和/或用于按照手动驱动装置的操作来操作外科器械的另一系统的装置。例如,手动驱动装置可包括例如上文所述的手动致动的应急组件1130。另外,例如,手动驱动装置的操作可电气地停用马达1102。在一些情况下,手动驱动装置的操作可将电池1104与马达1102断开连接。在某些情况下,手动驱动装置的操作可由马达控制器检测,该马达控制器可被配置为阻止马达1102的操作,即使可向马达1102供应电力。在各种情况下,马达控制器可包括例如微控制器7004。
进一步参见图54和图57,控制系统还可包括用于与器械的操作者通信的通信装置。在各种情况下,通信装置可在例如柄部1042上包括例如一个或多个发光二极管(LED)灯,这些LED灯可被配置为例如通知外科器械的操作者该外科器械处于特定操作状态。在至少一种情况下,柄部1042可包括例如绿色LED灯,该绿色LED灯在亮起时可指示外科器械处于例如组装、闭合和加电状态。在此类情况下,亮起的绿色LED灯可指示外科器械准备好使用。柄部1042可包括例如红色LED灯,该红色LED灯在亮起时可指示外科器械处于未组装、未闭合和/或掉电状态。在此类情况下,亮起的红色LED灯可指示外科器械未准备好使用。除上述之外,LED灯可与微控制器7004的输出通道电连通,其中微控制器7004可被配置为例如确定和/或设置外科器械的操作状态并且通过LED灯来通知该状态。在一些情况下,通信装置可包括例如柄部1042上的显示屏,该显示屏可被配置为将信息传送给外科器械的操作者。除上述之外,微控制器7004可与该显示屏电连通以例如传送外科器械的操作状态。
进一步参见图54和图57,并且另外参见图55和图56,控制系统可包括例如与微控制器7004电连通的多个开关。这些开关可包括上文讨论的开关和/或结合本文所述的外科器械的任何系统和/或子系统。这些开关可包括开关阵列,该开关阵列可被包括在与例如微控制器7004电连通的开关电路中。在某些情况下,该开关电路可包括例如16位I/O编码器,该编码器可与微控制器7004通信。此外,开关电路可包括与微控制器7004电连通的总线和电连接器4000中的一个或多个触点。最终,开关电路和开关阵列可以跨越例如柄部1042和轴组件1200。在各种情况下,微控制器7004可被配置为识别附接到柄部1042的轴组件,并且调节施加到例如击发构件1272和1280的击发行程的长度。2017年4月25日公布的名称为“CONTROL SYSTEMS FOR SURGICAL INSTRUMENTS”的美国专利9,629,629的全部公开内容以引用方式并入本文。
外科器械18000示于图61中。外科器械18000在许多方面类似于外科器械400。外科器械18000包括柄部18100、从柄部18100延伸的轴18200以及从轴18200延伸的端部执行器18300。端部执行器18300包括第一钳口18310和第二钳口18320,其中第一钳口18310可在打开夹紧位置和闭合夹紧位置之间移动,以将组织夹持在第一钳口18310和第二钳口18320之间。此外,端部执行器18300围绕关节运动接头18400可旋转地附接到轴组件18200。柄部18100包括框架18110和外壳18120。柄部18100还包括握持部18130、能够操作为致动端部执行器闭合系统的闭合致动器18140,和能够操作为致动钉击发系统的击发致动器18150。柄部18100还包括能够操作为致动端部执行器关节运动系统的关节运动致动器。第二钳口18320包括能够替换的钉仓18500,该钉仓包括可移除地储存在其中的钉,并且第一钳口18310包括被构造成能够使钉变形的砧座。外科器械18000还包括电动马达,该电动马达被配置为驱动外科器械18000的钉击发系统。各种钉击发系统公开于2006年2月21日发布的名称为“SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRINGSYSTEMS”的美国专利7,000,818中,并且该专利以引用方式并入本文。
现在参见图62,钉仓18500包括仓体18510,该仓体包括纵向狭槽18520、近侧端部18530和远侧端部18540。钉仓18500还包括限定在仓体18510中的多个钉腔18222和可移除地储存在钉腔中的钉。钉仓18500还包括滑动件18550(图69),在钉击发行程期间钉击发系统使该滑动件可向远侧移动以将钉向上驱动离开钉腔18222并且进入患者的组织中。钉仓18500还包括可移除的钉仓保持器或盖18570(图70),该盖在钉腔上方延伸并且保护钉。参见图70,该盖包括细长主体、从主体延伸的可释放地夹持仓体18510的柔性闩锁臂18574,和延伸到纵向狭槽18520中的纵向翅片18572。在许多情况下,钉仓盖18570充当临床医生与钉仓18500的钉之间的保护屏障。在各种情况下,钉仓盖18570允许临床医生在钉仓18500的顶部上放置例如他们的拇指,以将钉仓18500安置在第二钳口18320中而不接触钉。一旦已将钉仓18500安置在第二钳口18320中,就可移除仓盖18570然后可将外科器械18000插入患者体内。然而,如果在已安装钉仓18500之后未将仓盖18570移除,那么仓盖18570将阻止钉正确接触第一钳口18310的砧座。
外科器械18000还包括控制器,该控制器包括微处理器。外科器械18000还包括与控制器通信的RFID系统。该RFID系统包括一个或多个RFID读取器和一个或多个RFID标签,如将在下文更详细地讨论的。在各种实施方案中,RFID系统被配置为确定钉仓是否定位在外科器械中和/或钉仓是否是用于与外科器械一起使用的适当的钉仓。这样的RFID系统还可确定钉仓是否包括旨在用于该钉仓的正确部件。如果控制器确定钉仓适当并且钉仓内的部件正确,则外科器械18000可按预期来使用。如果控制器确定钉仓不适合或者钉仓内的一个或多个部件不正确,则控制器可采用某种方式限制外科器械的操作。在此类情况下,例如,控制器可允许端部执行器打开和闭合,并且/或者允许端部执行器进行关节运动,但是阻止执行钉击发行程。RFID系统还可用于确定钉仓是否已经正确定位在钉仓支撑件内。例如,RFID系统可指示钉仓的近侧端部和/或钉仓的远侧端部是否正确安置在钉仓通道内,并且如果钉仓的这些端部中的一个端部尚未完全安置,则控制器可阻止执行钉击发行程。此外,RFID系统可指示定位在外科器械中的钉仓是否是未用过的钉仓,或者钉仓是否已经被使用或以其他方式用过。如果控制器确定钉仓已经被用过,则控制器阻止执行钉击发行程,直到已经用未用过的钉仓替换用过的钉仓为止。RFID系统还可能够跟踪钉仓的可移动部件的运动,这将在下面更详细地讨论。
射频识别(RFID)在各种行业中用于跟踪和识别对象。RFID依赖于无线电波将数字存储的信息从RFID标签传输到RFID读取器或被配置为接收该信息的接收器。RFID技术使用包含电子存储的信息的RFID标签(有时称为芯片),和用于利用RFID标签进行识别和通信的RFID读取器。存在两种不同类型的RFID系统:主动RFID系统和被动RFID系统。主动RFID系统包括的RFID标签具有机载电源以广播其信号。主动RFID标签可在RFID标签内包括电池,这允许主动RFID标签独立于RFID读取器而工作。因此,主动RFID系统中的RFID标签不需要在发出信息之前等待从RFID读取器接收信号。相反,主动RFID标签自由地连续地发出信号或信标。许多能够商购获得的主动RFID系统通常在两个主频率范围(433MHz和915MHz)之一内操作,但是也可使用任何合适的频率范围。通常,RFID标签必须位于特定距离或频率范围内,以便由其对应的RFID读取器识别。
被动RFID系统包括的RFID标签不具有机载电源,而是从RFID读取器接收操作所需的能量。与主动RFID标签相反,被动RFID系统中的RFID标签在接收提示之前不会主动发出信号。相反,被动RFID标签在发出信号之前等待从RFID读取器接收信息。许多能够商购获得的被动RFID系统通常在三个频率范围即低频(“LF”)、高频(“HF”)和近场通信(“NFC”)和超高频率(“UHF”)内操作。LF带宽为125-134KHz,并且包括较长波长和大约一厘米至十厘米的短读取范围。HF和NFC带宽为13.56MHz,并且包括中等波长和一厘米到一米的典型读取范围。UHF带宽为865-960MHz,并且包括一米的高能量短波长,其转换为长读取范围。正如上文所述,可使用任何合适的频率。
存在包括不同尺寸的RFID标签的各种RFID系统。然而,一些更适合在需要跟踪非常小的物体的技术领域中使用。例如,Hitachi Chemical Co.Ltd.是RFID技术领域的领先制造商。由Hitachi Chemical Co.Ltd.制造的超小尺寸UHF RFID标签通常不大于1.0mm到13mm,并且实现了RFID标签和RFID读取器之间在几厘米或更大的距离上的通信。由于其紧凑性质,Hitachi RFID标签适用于需要识别的非常小的产品。每个Hitachi RFID标签包括天线、连接到天线的IC芯片以及密封IC芯片和天线的密封材料。因为Hitachi RFID标签在单个单元中结合了天线和IC芯片,所以Hitachi RFID标签足够地方便,可使用例如粘合剂或胶带来容易地附连到任何小物体。
Hitachi RFID标签包括正方形不锈钢板和金属天线。该天线包括LC谐振电路或任何其他合适的电路,并且电连接到板。在板和天线彼此连接之后,在单个单元中利用密封材料将天线和板密封在一起。密封材料主要由环氧树脂、碳和二氧化硅构成,以增强HitachiRFID标签的耐热性。也就是说,RFID标签的耐热性基本上取决于密封材料的耐热性。密封材料具有高耐热温度,能够在较短时间段耐受高达250至300℃并且在较长时间段耐受高达150℃。因此,Hitachi RFID标签具有比常规RFID标签更高的耐热性,并且在高温下也可正常操作。关于Hitachi RFID标签的其他信息可见于2015年10月27日公布的名称为“RFIDTAG”的美国专利9,171,244,该专利以引用方式并入本文。
如上所述,外科器械系统18000包括RFID系统,该RFID系统包括一个或多个RFID读取器和一个或多个RFID标签。在各种实施方案中,参见图62,RFID系统包括第一RFID标签18560a、第二RFID标签18560b和第三RFID标签18560c。图67示出了可以用于RFID标签18560a、18560b和18560c的Hitachi超小包装UHF RFID标签18900,尽管可使用任何合适的RFID标签。标签18900包括例如2.5mm×2.5mm×0.4mm的尺寸。标签18900包括基板或基部18910、安装到基板18910的微芯片18920和以周向图案安装到基板18910的天线18930,该周向图案与微芯片18920的输出通道或销连通。关于RFID标签18900的其他细节公开于美国专利9,171,244,该专利全文以引用方式并入本文。也就是说,可使用任何合适的RFID标签。
参见图62、图64至图66和图68,第一RFID标签18560a在第一位置A处附连到仓体18510。第二RFID标签18560b附连到能够滑动地定位在仓体18510中的滑动件18550,如图69所示,并且第三RFID标签18560c附连到盖18570,如图70所示。主要参见图66,外科器械18000包括第一RFID读取器18600、第二RFID读取器18700和第三RFID读取器18800。第一RFID读取器18600包括在外科器械柄部18100中的控制器和第二钳口18320之间延伸的柔性电路。第一RFID读取器18600包括第一感应线圈或传感器18620,当钉仓18500安置在第二钳口18320中时,第一感应线圈或传感器与第一RFID标签18560a对准。类似地,第二RFID读取器18700包括在外科器械柄部18100中的控制器和第二钳口18320之间延伸的柔性电路。第二RFID读取器18700在位置B处包括第二感应线圈或传感器18720(图62),当钉仓18500安置在第二钳口18320中时,第二感应线圈或传感器与第二RFID标签18560b对准。同样,类似地,第三RFID读取器18600包括在外科器械柄部18100中的控制器和第二钳口18320之间延伸的柔性电路。第三RFID读取器18800在位置C处包括第三感应线圈或传感器18820(图62),当钉仓18500安置在第二钳口18320中时,第三感应线圈或传感器与第三RFID标签18560c对准。
RFID标签18560a、18560b和18560c可以是主动的和/或被动的。当RFID标签18560a、18560b和18560c是主动RFID标签时,它们各自发射由其相应RFID读取器接收的信号。例如,第一RFID传感器18620从第一RFID标签18560a接收第一信标信号,第二RFID传感器18720从第二RFID标签18560b接收第二信标信号,并且第三RFID传感器18820从第三RFID标签18560c接收第三信标信号。第一信标信号、第二信标信号和第三信标信号可全部以相同频率发射或以不同频率发射。如果信标信号以相同频率发射,则必须控制信标信号的范围和/或RFID传感器的位置,使得RFID标签18560a、18560b和18560c与其相应RFID读取器传感器18620、18720和18820之间不存在串扰。RFID信标信号的范围由用于发射信标信号的功率和来自其相应电源或电池的电力的可用性来确定。通常,信标信号的范围与信号的发射功率成比例。如果信标信号以不同频率发射,则信号的范围和RFID传感器18620、18720和18820的相对定位可更灵活。在此类实施方案中,控制器包括一个或多个信号滤波器,诸如例如低通滤波器和/或高通滤波器,这些滤波器可用于确保从RFID标签18560a、18560b和18560c接收到的信号和数据被接收在正确的输入线或RFID读取器上。例如,低通滤波器可用于滤除第一RFID读取器18600上的第二和第三信标信号,高通滤波器可用于滤除第三RFID读取器18800上的第一和第二信标信号,并且低通滤波器和高通滤波器两者可用于滤除第二RFID读取器18700上的第一和第三信标信号。无论如何,一旦钉仓18500安置在第二钳口18320中,RFID读取器18600、18700和18800就接收来自其相应RFID标签18560a、18560b和18560c的数据。值得注意的是,随着钉仓18500被安置以及/或者当钉仓18500与第二钳口18320对准并且将被安置时,RFID标签18560a、18560b和18560c可开始与其相应的RFID读取器通信。
当RFID标签18560a、18560b和18560c是被动RFID标签时,RFID标签18560a、18560b和18560c不发射信号,直到它们从其相应RFID扫描器18600、18700和18800接收信号。例如,第一RFID标签18560a不发射信号,直到它被从RFID扫描器18600的第一传感器18620发射的信号激励。以此方式,第一传感器18620充当广播第一信号的发射天线,当第一信号由第一RFID标签18560a接收时,使得第一RFID标签18560a发射由第一传感器18620接收的第一返回信号。因此,第一传感器18620充当发射天线和接收天线两者。也就是说,第一RFID扫描器18600可包括作为发射电路的一部分的发射天线和作为接收电路的一部分的单独的接收天线。类似地,第二RFID标签18560b不发射信号,直到它被从RFID扫描器18700的第二传感器18720发射的信号激励。以此方式,第一传感器18720充当广播第二信号的发射天线,当第二信号由第二RFID标签18560b接收时,使得第二RFID标签18560b发射由第二传感器18720接收的第二返回信号。因此,第二传感器18720充当发射天线和接收天线两者。也就是说,第二RFID扫描器18700可包括作为发射电路的一部分的发射天线和作为接收电路的一部分的单独的接收天线。同样,类似地,第三RFID标签18560c不发射信号,直到它被从RFID扫描器18800的第三传感器18820发射的信号激励。以此方式,第三传感器18820充当广播第三信号的发射天线,当第三信号由第三RFID标签18560c接收时,使得第三RFID标签18560c发射由第三传感器18820接收的第三返回信号。因此,第三传感器18820充当发射天线和接收天线两者。也就是说,第三RFID扫描器18800可包括作为发射电路的一部分的发射天线和作为接收电路的一部分的单独的接收天线。
如上所述,第一RFID标签18560a附连到钉仓18500的仓体18510。第一RFID标签18560a使用一种或多种粘合剂附接到仓体18510。也就是说,第一RFID标签18560a可采用任何合适的方式附连到仓体18510。例如,参见图68,在注塑成型过程期间,第一RFID标签18560a可与仓体18510一体地模制。在此类情况下,第一RFID标签18560a的至少一部分嵌入在仓体18510中。也就是说,设想了其中整个第一RFID标签18560a嵌入在仓体18510中的实施方案。此外,设想了其中仓体18510的壁限定凹陷部或凹坑并且第一RFID标签18560a定位在该凹陷部中的实施方案。在各种情况下,RFID标签18560a的周边与仓体18510中的凹陷部的周边匹配。
当第一RFID扫描器18600从第一RFID标签18560a接收第一信号并且第一信号或来自第一信号的数据被传送到外科器械18000的控制器时,该控制器确定钉仓存在于第二钳口18520中。在各种实施方案中,控制器执行认证评估以确定从第一RFID标签18560a接收的数据与来自可接受的钉仓的数据匹配。关于可接受的钉仓的数据可存储在控制器的存储器装置中,并且/或者可存储在例如机外控制器和/或云环境中。如果控制器确定钉仓存在于第二钳口18320中并且钉仓是相容的,则控制器将利用RFID系统的第二RFID标签18560b和第三RFID标签18560c执行额外检查,如下文更详细地讨论。也就是说,设想了这样的实施方案,其中第一RFID标签18560a是RFID系统中唯一的RFID标签,并且一旦经由第一RFID标签18560a验证了相容的钉仓的存在,控制器就可解锁钉击发系统。
如上所述,第二RFID标签18560b附连到钉仓18500的滑动件18550。第二RFID标签18560b使用一种或多种粘合剂附接到滑动件18550。也就是说,第二RFID标签18560b可采用任何合适的方式附连到滑动件18550。例如,参见图69,在注塑成型过程期间,第二RFID标签18560b可与滑动件18550一体地模制。在此类情况下,第二RFID标签18560b的至少一部分可嵌入滑动件18550中。也就是说,设想了其中整个第二RFID标签18560b嵌入在滑动件18550中的实施方案。此外,设想了其中滑动件18550的壁限定凹陷部或凹坑并且第二RFID标签18560b定位在该凹陷部中的实施方案。在各种情况下,RFID标签18560b的周边与滑动件18550中的凹陷部的周边匹配。
当第二RFID扫描器18700接收来自第二RFID标签18560b的第二信号并且第二信号或来自第二信号的数据被传送到外科器械18000的控制器时,该控制器确定滑动件在其近侧未击发位置存在于钉仓内。利用该信息,控制器可确定钉仓处于未用过的状态。如果滑动件18550不处于其近侧未击发位置,则第二RFID标签18560b将不在第二RFID扫描器18700的范围内,并且控制器将确定定位在第二钳口18320中的钉仓已经至少部分地用过。在此类情况下,控制器将不解锁钉击发系统,直到已经用相容的未用过的钉仓替换该钉仓为止。
在各种实施方案中,控制器执行认证评估以确定从第二RFID标签18560b接收的数据与对应于由第一RFID扫描器18600识别的钉仓的数据匹配。如果控制器经由来自第二RFID标签18560b的数据确定滑动件18550是存在于第二钳口18320中的钉仓的适当部件,则控制器将利用RFID系统的第三RFID标签18560c执行额外检查,如下文更详细地讨论。也就是说,设想了这样的实施方案,其中不包括第三RFID标签18560c,并且一旦经由第一RFID标签18560a和第二RFID标签18560b验证相容的未击发钉仓的存在,如上所述,则控制器可解锁钉击发系统。
如上所述,参见图70,第三RFID标签18560c附连到钉仓18500的可移除盖18570。第三RFID标签18560c使用一种或多种粘合剂附接到盖18570。也就是说,第三RFID标签18560c可采用任何合适的方式附连到盖18570。例如,参见图70,在注塑成型过程期间,第三RFID标签18560c可与盖18570一体地模制。在此类情况下,第三RFID标签18560c的至少一部分可嵌入盖18570中。也就是说,设想了其中整个第三RFID标签18560c嵌入在盖18570中的实施方案。此外,设想了其中盖18570的壁限定凹陷部或凹坑并且第三RFID标签18560c定位在该凹陷部中的实施方案。在各种情况下,RFID标签18560c的周边与盖18570中的凹陷部的周边匹配。
当第三RFID扫描器18800从第三RFID标签18560c接收第三信号并且第三信号或来自第三信号的数据被传送到外科器械18000的控制器时,该控制器确定盖18570附接到钉仓。利用该信息,控制器可确定临床医生在盖18570存在的情况下将钉仓插入外科器械18000中,并且因此不会干扰储存在仓体18510中的钉。如果在仓体18510上未检测到盖18570,则控制器将确定钉仓可能损坏。在此类情况下,控制器将不解锁钉击发系统,直到已经用相容的未用过的而且未损坏的钉仓替换该钉仓为止。
在各种实施方案中,控制器执行认证评估以确定从第三RFID标签18560c接收的数据与对应于由第三RFID扫描器18700识别的钉仓的数据匹配。如果控制器经由来自第三RFID标签18560c的数据确定盖18570是存在于第二钳口18320中的钉仓的适当部件,则控制器解锁钉击发系统。附加的RFID标签和RFID标签扫描器可用于评估定位在外科器械中的钉仓的存在、状态和/或相容性。
如上所述,第二RFID扫描器18700由外科器械18000的控制器用于评估滑动件18550是否处于其近侧未击发位置。如果不存在,则控制器无法评估滑动件18550的位置,因为它不在第二RFID 18700扫描器的通信范围内。也就是说,外科器械可包括多于一个RFID扫描器,这些RFID扫描器由外科器械的控制器用于评估滑动件18500的位置,并且因此评估钉击发行程的进度。再次参见图66,外科器械18000的第一RFID扫描器18600和第三RFID扫描器18800可用于跟踪滑动件18500的位置。当滑动件18500在钉击发行程期间向远侧移动时,第二RFID标签18560b经过第一RFID扫描器18600的传输范围18610和第三RFID扫描器的传输范围18810。当第二RFID标签18560b的第二信号被第一RFID扫描器18600检测到时,控制器确定滑动件18550处于邻近位置A。同样,当第二RFID标签18560b的第二信号被第三RFID扫描器18800检测到时,控制器确定滑动件18550处于邻近位置C。在各种实施方案中,RFID系统可包括与钉仓的远侧端部相邻的RFID扫描器,该RFID扫描器与控制器通信以检测滑动件18550何时已经到达钉击发行程的末尾。
许多能够商购获得的钉仓以标准长度出售。例如,Johnson&Johnson子公司Ethicon销售被构造成能够施加30mm长的钉图案的钉仓、被构造成能够施加45mm长的钉图案的钉仓,和被构造成能够施加60mm长的钉图案的钉仓等。30mm、45mm和60mm长度不表示钉仓的总长度;相反,这些长度表示这些钉仓可适用的钉图案的长度。也就是说,Ethicon还销售被构造成能够接收30mm的钉仓的外科缝合器。此类外科缝合器包括被构造成能够使30mm图案中的钉变形的砧座。Ethicon还销售被构造成能够接收45mm钉仓的外科缝合器和被构造成能够接收60mm钉仓的外科缝合器,并且具有被构造成能够分别使45mm钉图案和60mm钉图案变形的砧座。如果不考虑其他因素,则被设计成产生30mm长的钉图案的砧座将不能使60mm钉图案的所有钉变形。在各种实施方案中,除上述之外,一种外科器械可包括RFID系统,该RFID系统被配置为评估已经插入到该外科器械中的钉仓是否具有与可由该外科器械的砧座变形的钉图案匹配的钉图案,如下文更详细地描述。
除上述之外,参见图74和图75,外科器械的端部执行器18300'包括第一钳口18310和第二钳口18320,其中第二钳口18320被构造成能够将能够替换的钉仓19700接收在其中。钉仓19700在许多方面类似于钉仓18500,并且包括可移除地储存在其中的多个钉。储存在钉仓19700中的钉的图案与限定在第一钳口18310的砧座中的钉成形凹坑的图案匹配。图74中示出了另一个钉仓19600。类似于钉仓19700,钉仓19600可被插入到第二钳口18320中;然而,钉仓19600产生与由钉仓19700产生的钉图案不同长度或长度更短的钉图案。因此,钉仓19600不适合或不合适与外科器械一起使用,而钉仓19700适合或合适与外科器械一起使用。该外科器械包括RFID系统,该RFID系统与该外科器械的控制器通信,该控制器用于当错误钉仓(诸如例如钉仓19600)或没有钉仓定位在第二钳口18320中时阻止该外科器械执行钉击发行程。对应地,该控制器被配置为当将正确的钉仓(诸如钉仓19700)定位在第二钳口18320中并由控制器识别时允许缝合器械用于执行钉击发行程。
端部执行器18300'包括第一RFID扫描器和第二RFID扫描器,该第一RFID扫描器包括位于第二钳口18320的近侧端部的第一传感器,该第二RFID扫描器包括位于第二钳口18320的远侧端部的第二传感器。钉仓19700包括仓体19710、安装到仓体19710的近侧端部的第一RFID标签19760a和安装到仓体19710的远侧端部的第二RFID标签19760b。当钉仓19700被安置在第二钳口18320中时,第一RFID标签19760a与第一RFID扫描器的传感器对准,并且第二RFID标签19760b与第二RFID扫描器的传感器对准。在此类情况下,当这两个RFID扫描器检测到其相应RFID标签存在时,外科器械的控制器能够验证第二钳口18320中正确的钉仓的存在。如本文所讨论的,该控制器可被配置为认证从RFID标签接收的信号和/或数据是否匹配对应于相容的钉仓的一组信号和/或数据。无论如何,控制器被配置为一旦该控制器确定安置在第二钳口18320中的正确钉仓存在,就解锁钉击发系统。
除上述之外,钉仓19600包括仓体19610、安装到仓体19610的近侧端部的第一RFID标签19660a和安装到仓体19610的远侧端部的第二RFID标签19660b。当钉仓19600被安置在第二钳口18320中时,第二RFID标签19660b与第二RFID扫描器的传感器对准;然而,参见图75,第一RFID标签19660a不与第一RFID扫描器对准。实际上,第一RFID标签19660a没有定位在第一RFID扫描器的传输或通信范围内。因此,控制器可从第二RFID标签19660b接收信号,但无法从第一RFID标签19660a接收信号。在此类情况下,控制器被配置为确定具有不正确长度的钉仓已经被安置在第二钳口18320中。换句话说,由于第二RFID扫描器对第二RFID标签19660b的检测,控制器可确定钉仓存在于第二钳口18320中,但是由于缺少由第一RFID扫描器检测到的信号,该钉仓具有不合适的长度。控制器被配置为将钉击发系统保持处于锁定状态,直到控制器已经确定正确的钉仓安置在第二钳口18320中。在至少一个这样的实施方案中,控制器不对击发致动器输入进行响应,并且不向钉击发系统的电动马达供电,直到在第二钳口18320中检测到正确的钉仓存在为止。
图76中示出了图74和图75的实施方案的控制器的算法16000。在步骤16100处,控制器使用第二RFID扫描器评估第二RFID标签19660b的存在。如果控制器未从第二RFID扫描器接收到信号,则控制器确定第二钳口18320中不存在钉仓,并且在步骤16110处向临床医生指示不存在钉仓。在各种情况下,外科器械包括与控制器通信的显示屏,该显示屏用于将钉仓的不存在传达给临床医生。在此类情况下,算法16000返回到步骤16100并且等待钉仓被插入到可与第二RFID扫描器通信的第二钳口18320中。如果控制器在步骤16100处从第二RFID扫描器接收信号,则控制器在步骤16200处使用第一RFID扫描器评估第一标签19660a的存在。如果控制器未从第一RFID扫描器接收到信号,则控制器确定不相容的钉仓存在于第二钳口18320中,在步骤16210处向临床医生指示该情况。可经由例如显示屏向临床医生提供该指示。在此类情况下,算法16000返回到步骤16100并且等待相容的钉仓被插入到可与第一和第二RFID扫描器通信的第二钳口18320中。如果控制器在步骤16200处从第一RFID扫描器接收信号,则控制器在步骤16300处认证第一和/或第二RFID标签的真实性。在各种情况下,控制器包括存储在存储器芯片或存储器装置中的多组数据,这些数据可用于认证从第一RFID标签19660a和第二RFID标签19660b接收的数据。例如,如果来自第一RFID信号和第二RFID信号的数据匹配存储在存储器芯片中关于的第一RFID信号和第二RFID信号的数据组,则在步骤16300处控制器可确定定位在第二钳口18320中的钉仓是真实的。在步骤16300处如果接收到的数据不匹配所存储的数据,则在步骤16310处控制器例如经由显示屏向临床医生指示不真实的钉仓存在于第二钳口18320中。在此类情况下,算法16000返回到步骤16100并且等待相容的真实钉仓被插入到第二钳口18320中。
一旦控制器确定真实的钉仓定位在第二钳口18320中,在步骤16400处控制器就使能钉击发系统。此时,在步骤16500处控制器对来自钉击发致动器的输入进行响应,并且在接收到该输入时在步骤16600处向钉击发系统的电动马达施加电压电势,假设已经满足用于执行钉击发行程的所有其他条件。例如,控制器被配置为在第一钳口18310处于打开位置时不对来自钉击发致动器的输入进行响应。然而,当第一钳口18310闭合时,控制器可在步骤16500和16600处对来自钉击发致动器的输入进行响应。如果没有从钉击发致动器接收输入,则控制器在步骤16510处等待这样的输入。
在各种实施方案中,除上述之外,钉仓19700和/或第二钳口18320包括当钉仓19700安置在第二钳口18320中时在钉仓19700与第二钳口18320之间产生卡扣配合的特征。这种卡扣配合布置将钉仓19700牢固地保持在第二钳口18320中,但仍然允许钉仓19700从第二钳口18320移除。在一些情况下,将钉仓19700的远侧端部安置到第二钳口18320中相对容易,而安置钉仓19700的近侧端部可由于第一钳口18310的接近而在一定程度上很困难。在各种实施方案中,RFID系统可用于确定钉仓是否完全安置在第二钳口18320中。例如,如果钉仓19700的近侧端部完全安置在第二钳口18320中并且钉仓19700的远侧端部未安置在第二钳口18320中,则控制器将由于从第一RFID读取器接收到的信号而检测到钉仓19700的存在,但是将由于不存在来自第二RFID读取器的信号而确定钉仓19700的远侧端部未完全安置。在此类情况下,控制器可例如经由显示器将这种情况传达给临床医生,并且向临床医生提供关于如何修复该问题的指导。控制器还可被配置为当第二RFID读取器从第二RFID标签19760b接收到信号并且第一RFID读取器未从第一RFID标签19760a接收到信号时确定钉仓的近侧端部未完全安置在第二钳口18320中。在此类情况下,控制器可通过认证来自第二RFID标签19760b的部分数据组来识别钉仓19700是未安置但仍然正确的钉仓,或至少假设钉仓19700是正确的钉仓。无论如何,如果控制器确定钉仓19700的端部尚未完全安置,则控制器将防止钉击发行程被致动。一旦钉仓19700的两个端部已经完全安置,则控制器对来自击发系统致动器的输入进行响应,假设已经满足用于执行钉击发行程的所有条件。
如上所述,钉仓包括可移除地储存在其中的钉,该钉由滑动件和/或击发构件从钉仓射出,该滑动件和/或击发构件在钉击发行程期间移动经过钉仓。在各种实施方案中,滑动件直接接触钉,而在其他实施方案中,滑动件接触钉驱动器,钉驱动器支撑钉并且在钉击发行程期间将钉驱动到钉仓之外。钉仓的仓体、滑动件和/或钉驱动器常常在钉击发行程期间经历显著的应力和应变,并且在这种情况下,可能不期望再次使用或再次装载具有新钉的用过的钉仓。据此,设想了各种实施方案,其中钉仓的一个或多个特征在钉击发行程期间和/或之后被有意破坏,以防止钉仓被再次使用。参见图72,钉仓19500包括仓体19510、可移除地储存在仓体19510中的钉、能够移动地储存在仓体19510内的钉驱动器,和滑动件18550'(图71),该滑动件被构造成能够在钉击发行程期间在近侧位置(图72)和远侧位置(图72B)之间移动。类似于滑动件18550,滑动件18550'包括安装到其上的RFID标签18560b,并且与上述类似,外科器械18000的RFID系统被配置为当钉仓19500装载到外科器械18000时验证滑动件18550'处于其近侧未击发位置(图72)。当钉仓19500先前尚未被击发时,参见图73A,RFID系统可与RFID标签18560b通信并且允许执行钉击发行程。然而,在钉击发行程结束时,滑动件18550'的RFID标签18560b接触定位在仓体19510的远侧端部的刀19590并且被该刀切割,如图73B所示。当以这种方式切割RFID标签18560b时,RFID标签18560b不再能够发射信号,并且即使滑动件18550'被推回或重置到其近侧未击发位置以重新装载钉仓19500,重新装载的钉仓19500可由于损坏的RFID标签18560b而不会通过由外科器械18000的RFID系统执行的认证测试。因此,外科器械18000将不能利用定位在外科器械18000中的重新装载的钉仓19500执行钉击发行程。
再次参见图71,RFID标签18560b安装到滑动件18550'的中心或纵向部分18552,该滑动件在钉仓19500的纵向狭槽内滑动。RFID标签18560b部分地嵌入中央部分18552中,并且RFID标签18560b的一部分暴露。更具体地,RFID天线的一部分暴露。也就是说,RFID标签18560b可在任何合适的位置处安装到滑动件18550',例如安装在滑动件18550'的轨道18554上。RFID标签18560b的暴露的部分面向滑动件18550'的远侧端部,使得RFID标签18560b在钉击发行程结束时与仓刀19590接触。也就是说,设想了其中滑动件18550'上的RFID标签18560b在钉击发行程开始时被破坏的实施方案。此外,设想了其中在使用期间有意破坏和/或禁用其他钉仓部件的RFID标签的实施方案。下文进一步讨论了一个此类实施方案,其中当从钉仓移除时,钉仓盖的RFID标签被破坏和/或禁用。在这种情况下,使用过的钉仓盖可能不会附接到钉仓以通过RFID系统执行的认证测试。
如上所述,外科器械18000的RFID系统包括三个RFID读取器,其中每个RFID读取器能够与相应RFID标签通信和/或从相应RFID标签接收信号。同样如上所述,RFID读取器可包括例如延伸到外科器械18000的端部执行器18300中的柔性电路。在此类情况下,参见图66,柔性电路可安装到第二钳口18320的壁,并且可被设定尺寸和构造成能够容纳安置在第二钳口18320中的钉仓。再次参见图66,第二钳口18320包括底壁或支撑件18322和从底壁18322向上延伸的两个侧向侧壁18324,这两个侧壁被构造成能够将钉仓接收在其间。两个RFID柔性电路安装到一个侧壁,并且另一个RFID柔性电路安装到另一个侧壁。在各种情况下,使用例如一种或多种粘合剂将RFID柔性电路安装到侧壁。除了或代替上述方式,可使用紧固件将RFID柔性电路安装到第二钳口18320的壁。在各种另选的实施方案中,参见图77,RFID扫描器可以是一个柔性电路的一部分。在至少一个这样的实施方案中,RFID扫描器包括柔性电路的子电路。
再次参见图77,柔性电路19900包括柔性基板和嵌入柔性基板中的导体。例如,柔性基板由绝缘或非导电材料(诸如例如塑料)构成,并且导体由例如铜构成。柔性电路19900安装到第二钳口18320的底壁18322,并且包括第一RFID扫描器19100、第二RFID扫描器19200和第三RFID扫描器19300。第一RFID扫描器19100包括传感器电路,该传感器电路包括两个导体和第一传感器线圈或阵列19120。其中一个导体包括限定在第一传感器19120中的线圈部分,和将该线圈部分的端部连接到另一个导体以完成第一RFID扫描器19100的电路的导电连接器。第一传感器19120安装到第二钳口18320的第一侧壁18324。类似地,第二RFID扫描器19200包括传感器电路,该传感器电路包括两个导体和第二传感器线圈或阵列19220。其中一个导体包括限定在第二传感器19220中的线圈部分,和将该线圈部分的端部连接到另一个导体以完成第二RFID扫描器19200的电路的导电连接器19222。第二传感器19220安装到第二钳口18320的第二侧壁18324。同样,类似地,第三RFID扫描器19300包括传感器电路,该传感器电路包括两个导体和第三传感器线圈或阵列19320。其中一个导体包括限定在第三传感器19320中的线圈部分,和将该线圈部分的端部连接到另一个导体以完成第三RFID扫描器19300的电路的导电连接器。第三传感器19320安装到第二钳口18320的底壁18322。
再次参见图66,当钉仓诸如例如钉仓18500安置在第二钳口18320中时,第一RFID标签18560a与第一RFID扫描器18600的传感器18620对准。在各种实施方案中,第一RFID标签18560a包括基本上平面的构型。更具体地,第一RFID标签18560a的基部、微芯片和标签天线以看起来扁平的方式布置。第一RFID扫描器18600的传感器18620(类似于RFID扫描器19200的传感器19220)还包括看起来扁平的基本上平面的构型。当钉仓18500被安置在第二钳口18320中时,第一RFID标签18560a平行于或至少基本上平行于第一传感器18620。当第一RFID标签18560a和第一传感器18620的两个平面之间存在大约10度或更小的角度时,它们基本上彼此平行。
此外,除上述之外,第一RFID标签18560a的标签天线围绕标签天线轴线TA周向延伸(图67),该标签天线轴线正交或至少基本上正交于由第一RFID标签18560a限定的平面。当标签天线轴线TA与由第一RFID标签18560a限定的平面之间存在大约80度至100度角时,标签天线轴线TA正交于第一RFID标签18560a。类似地,第一传感器18620的读取器天线围绕读取器天线轴线SA周向延伸(图77),该读取器天线轴线正交或至少基本上正交于由第一传感器18620限定的平面。当读取器天线轴线SA与由第一读取器天线18620限定的平面之间存在大约80度至100度角时,读取器天线轴线SA正交于第一读取器天线18620。当钉仓18500被安置在第二钳口18320中时,标签天线轴线TA与读取器天线轴线SA对准。在各种情况下,标签天线轴线TA与读取器天线轴线SA共线。可在第二RFID标签18560b和第二RFID读取器18700的天线18720之间实现类似的布置。另外,可在第三RFID标签18560c和第三RFID读取器18800的天线18820之间实现类似的布置。
再次参见图66,第一RFID标签18560a、第二RFID标签18560b和第三RFID标签18560c在第二钳口18320中未纵向对准。更具体地,第二RFID标签18560b相对于第一RFID标签18560a定位在近侧,并且另外第三RFID标签18560c相对于第一RFID标签18560a定位在远侧。如果第一RFID标签18560a、第二RFID标签18560b和第三RFID标签18560c是主动RFID标签,则可建立RFID标签18560a、18560b和18560c的传输范围,使得它们不重叠。此外,第二RFID读取器18700的第二传感器18720相对于第一RFID读取器18600的第一传感器18620定位在近侧,并且另外第三RFID读取器18800的第三传感器18820相对于第一传感器18620定位在远侧。同样如图66所示,第二传感器18720的第二传输范围18710在第一传感器18620的第一传输范围18610近侧而且不与之叠重,并且另外第三传感器18820的第三传输范围18810在第一传感器18620的第一传输范围18610远侧而且不与之重叠。
除上述之外,参见图64至图66,第一RFID标签18560a和第二RFID标签18560b在第二钳口18320中未横向对准。更具体地,第一RFID标签18560a定位在仓体18510的侧向侧壁18514中,并且第二RFID标签18560b定位在纵向狭槽18520中。此外,第一RFID标签18560a和第三RFID标签18560c在第二钳口18320中未横向对准。更具体地,第一RFID标签18560a定位在仓体18510的侧向侧壁18514中,并且第三RFID标签18560c定位在纵向狭槽18520中。
如本文所讨论的,外科器械诸如例如外科器械18000的控制器被配置为基于来自RFID系统的反馈防止钉击发行程执行或允许钉击发行程执行。也就是说,控制器可被配置为基于来自RFID系统的反馈来以一种或多种其他方式改变外科器械的操作。例如,控制器可被配置为基于来自RFID系统的反馈改变钉击发行程的速度。在至少一个这样的实施方案中,控制器可使用从RFID标签获得的数据和/或存储在存储器装置中的数据,使钉击发系统的电动马达以期望的速度运行以用于安置在外科器械中的钉仓。在至少一种情况下,该数据指示电动马达在钉击发行程期间以较慢的速度运行。当钉仓包括可释放地附接到钉仓的平台的可植入附属物时,这种布置可以是有用的。例如,当钉仓包括长钉或者在抵靠砧座变形之前高度在大约2.5mm至大约5.0mm之间的钉时,这种布置也可以是有用的。在其他情况下,该数据指示电动马达在钉击发行程期间以较快的速度运行。当钉仓不包括可释放地附接到钉仓的平台的可植入附属物时,这种布置可以是有用的。例如,当钉仓包括短钉或者在抵靠砧座变形之前高度小于大约2.5mm的钉时,这种布置也可以是有用的。
在各种外科手术期间,使用包括至少一个可替换部件的外科器械。重要的是,利用功能性和/或相容部件来替换此类可替换部件。在本文中更详细地描述的各种识别系统验证与外科器械的部件的相容性和/或验证该部件的操作状态。例如,识别系统可用于例如确保包含可替换部件的包装尚未被破坏和/或被篡改,警告临床医生在打开产品包装之前部件与外科器械相容或不相容,以及/或者如果关于可替换部件的特定制造批次或类型存在召回则提醒临床医生。
本文所述的识别系统可以是主动系统或被动系统。在各种实施方案中,使用主动识别系统和被动识别系统的组合。被动系统可包括例如条形码、快速响应(QR)码和/或射频识别(RFID)标签。被动系统不包括内部电源,并且本文所述的被动系统需要读取器来发送第一信号,诸如例如询问信号。
条形码的实施需要使用光学条形码读取器和/或扫描器。条形码需要相对于扫描器正确定向,并且扫描器需要无障碍地看到条形码以便正确扫描条形码。出于至少这些原因,条形码通常印刷到纸或塑料上。扫描器对条形码的条进行解码,这些条通常表示一系列数字。解码的信息被发送到计算机或控制器,该计算机或控制器解释已经读取的内容。该信息可包含关于例如可替换部件的制造商、可替换部件的类型或型号和/或可替换部件与外科器械一起使用的相容性信息的数据。
另一种被动识别系统包括快速响应(QR)码。QR码是一种矩阵条形码。QR码通常包括指向网站或用于在移动设备上使用的应用程序的定位符、标识符或跟踪器的数据。Qr码使用四种标准化编码模式来有效存储数据。这四种标准化编码模式包括数字、字母数字、字节/二进制和日本汉字。QR码由在白色背景上以方形网格布置的黑色方块组成,它能够由成像装置诸如例如相机读取。使用Reed-Solomon纠错来处理所捕获的图像,直到可以适当地解释所捕获的图像。然后从以图像的水平分量和垂直分量存在的图案中提取所需数据。所需数据可包括例如可替换部件的制造商、可替换部件的类型或型号和/或可替换部件与外科器械的相容性信息。
被动射频识别(RFID)系统通过使用无线电频率来读取信息。此类被动RFID系统包括RFID扫描器和不具有内部电源的RFID标签。该RFID标签由从RFID扫描器传输的电磁能供电。每个RFID标签包括存储关于可替换部件和/或可替换部件与之相容的外科器械的信息的芯片,诸如例如微芯片。虽然该芯片可仅包含基本识别号,但在各种情况下,该芯片可存储额外的信息,诸如例如制造数据、运输数据和/或维护历史。每个RFID标签包括允许RFID标签与RFID扫描器通信的无线电天线。无线电天线延长了RFID标签可从RFID扫描器接收信号并且将响应信号发送回RFID扫描器的范围。在被动RFID系统中,RFID扫描器还包括其自身的天线,该天线发射将定位在预定范围内的RFID标签激活的无线电信号。RFID扫描器被配置为接收从RFID标签“反弹回来”的响应信号,从而允许RFID扫描器捕获表示可替换部件的识别信息。在各种情况下,该一个或多个响应信号包括与询问信号相同的信号。在各种情况下,该一个或多个响应信号包括来自询问信号的修改信号。在各种情况下,RFID扫描器还能够将信息直接写到或编码到RFID标签上。无论如何,RFID扫描器上的软件能够将关于可替换部件的信息传递到控制器,诸如外科器械的控制系统、外科集线器和/或远程外科系统。各种外科集线器描述于2018年12月4日提交的名称为“METHOD OF HUB COMMUNICATION”的美国专利申请序列号16/209,395中,该专利申请据此全文以引用方式并入。RFID扫描器被配置为一次读取多个RFID标签,因为这些RFID标签由无线电信号激活。
主动射频识别(RFID)系统也包括RFID标签和RFID扫描器。然而,主动RFID系统中的RFID标签包括内部电源。主动RFID系统利用电池供电的RFID标签,该RFID标签被配置为连续广播其自身的信号。一种类型的主动RFID标签通常被称为“信标”。此类信标RFID标签不等待从RFID扫描器接收第一信号。相反,信标RFID标签连续地发射其存储的信息。例如,信标可以每3-5秒的间隔发出其信息。另一种类型的主动RFID标签包括转发器。在此类系统中,RFID扫描器首先发射信号。RFID转发器标签然后利用相关信息将信号发送回RFID扫描器。此类RFID转发器标签系统是有效的,因为当例如RFID标签超出RFID扫描器的范围时,它们会节省电池寿命。在各种情况下,主动RFID标签包括机载传感器以跟踪环境参数。例如,机载传感器可跟踪水分含量、温度和/或可能相关的其他数据。
替换钉仓在制造之后包含在密封包装中,直到该包装在手术室中打开。各种形式的包装包括例如纸塑袋、织造和/或非织造材料包裹件,和刚性容器。图78示出了密封包装25000的示例。所示包装25000是纸塑袋。包装25000包括第一层25010和第二层25020。第一层25010和第二层25020在钉仓25100周围形成保护屏障,该保护屏障可与外科器械一起使用。粘合剂将第一层25010和第二层25020粘结在一起以在物品周围形成气密和/或流体密封件和/或袋。粘合剂在没有折痕、褶皱和/或间隙的情况下形成密封件。例如,由粘合剂产生的密封件防止污染物与钉仓25100接触和/或防止钉仓25100的部件被错放。在各种情况下,钉仓25100被气密地密封在包装25000内。在各种情况下,包装25000提供完全不透流体的密封件。在各种情况下,包装提供完全的流体密封和气密密封件。
第一层25010包括定位在该密封件外部的第一拐角25011,并且第二层25020包括定位在该密封件外部的第二拐角25021。临床医生可通过将第一层25010与第二层25020剥离来暴露所密封的钉仓25100。在各种情况下,临床医生可通过将第一拐角25011和第二拐角25021保持在单独的手中并且在远离第二层25021的方向上拉动第一拐角25011来暴露所密封的钉仓25100,但是也可使用任何合适的打开方法。
第一层25010和第二层25020由诸如例如具有层合内表面的纸的材料构成。该层合内表面提供防止污染物进入包装25000的密封部分的屏障。在各种情况下,第一层25010和第二层25020由塑料构成。第一层25010和第二层25020可由具有特定透明度的材料构成,以允许临床医生例如观察包装25000的内容物。正如上文所述,任何合适的材料或材料的组合可用于第一层25010和/或第二层25020。
包装25000包括促进外科器械和/或临床医生选择与特定外科器械和/或特定外科手术相容的钉仓25100的各种识别系统。包装25000的第一层25010包括以某种方式表示包装25000的内容物的各种视觉指示器。例如,如图78所示,包装25000内包含的产品的名称25012被印刷或以其他方式显示在第一层25010上。
包装25000还包括在第一层25010上显示的一个或多个被动识别系统。例如,包装25000包括QR码25014。QR码25014可辅助例如分类和/或跟踪包装25000的状态。还可以在破坏包装25000的密封件之前扫描QR码25014,以确保内容物适合与特定器械一起使用和/或在特定外科手术期间使用。
除了在第一层25010上显示的包装25000的内容物的名称25012之外,包装25000包括序列号25016,该序列号可例如提供临床医生在决定是否打开包装25000之前可利用的更详细的信息。例如,序列号25016可包括特定于外科系统和/或对于外科系统唯一的字母数字符号。每个字母数字符号可表示相容的组装外科系统的部件。例如,该字母数字符号可表示钉仓、端部执行器、轴组件、外科器械等。序列号25016可表示另外的因素,诸如制造批次、制造日期等。在各种情况下,序列号25016可包括如本文更详细描述的加密信息。
设想包装25000可包括本文讨论的各种形式的识别系统中的一些或全部识别系统。
图79和图80示出了与包装25000集成的RFID系统25200。RFID系统25200包括RFID标签25210和绝缘体25220。RFID标签25210包括存储关于包装25000和/或包装25000的内容物的信息的芯片,诸如例如微芯片。在各种情况下,该芯片包括基本识别号。可将这种基本识别分配给可将芯片的存在传送到RFID扫描器的芯片。在各种情况下,该芯片包括另外的信息,诸如例如制造数据、运输数据和/或相容性数据。RFID标签25210还包括被配置为促进RFID标签25210与RFID扫描器之间的通信的无线电天线。
绝缘体25220附接到包装25000的第一层25010,而RFID标签25210附接到包装25000的第二层25020。当该包装处于密封构型时,绝缘体25220附连到或以其他方式连接到RFID标签25210。RFID标签25210是主动RFID系统25200的一部分,包括在包装25000打开时激活的内部电源。在包装25000打开之前,绝缘体25220与RFID标签25210之间的接合部防止电源向RFID标签25210提供电力。在此类情况下,RFID标签25210无法发射信号。当临床医生通过将第一层25010从第二层25020剥离时破坏包装25000的密封,绝缘体25220与RFID标签25210断开连接或以其他方式分离。在绝缘体25220与RFID标签25210分离时,电源和RFID标签25210之间的电路闭合,并且RFID标签25210通电。如图80所示,RFID标签25210在通电时开始发射信号25215。RFID标签25210被配置为以任何适当频率和/或任何适当的持续时间发射信号25215。例如,RFID标签25210可连续地发射信号25215,或者RFID标签25210可每3-5秒发射信号25215。信号25215包括存储在芯片上的信息中的一些或全部信息。在各种情况下,信号25215可用于提醒外科器械,包装25000在运输和/或储存期间已被篡改或者简单地说包装25000已经被打开。
RFID标签25210被配置为与RFID扫描器通信。一旦绝缘体25220已被移除,RFID标签25210的内部电源就允许RFID标签25210在接收到来自RFID扫描器的第一信号(诸如询问信号)之前发射信号25215。RFID扫描器包括扫描器天线,该扫描器天线被配置为从RFID标签25210发射和/或接收无线电信号25215。在各种情况下,RFID扫描器包括读取能力和写入能力。然后,RFID扫描器上的软件能够将所收集的信息从RFID标签25210传递到外科器械的控制器以用于进一步解释。RFID扫描器位于RFID标签25210的预定范围内,该预定范围允许RFID扫描器能够接收由RFID标签25210发射的发射信号25215。根据应用,RFID扫描器可位于外科器械上、包装的内容物上或远程定位在控制台上,诸如与外科器械通信的远程外科系统。另外,控制器可定位在任何合适的位置,诸如例如外科器械或远程控制台上。
在各种实施方案中,可使用包括安装到钉仓25100的RFID标签的RFID系统。除上述之外,该RFID标签包括位于钉仓25100内的内部电源。该RFID标签的合适位置包括例如在钉仓的滑动件上、在钉仓的侧壁上或在钉仓组件的保持器上。类似于绝缘体25220的绝缘体附接到包装25000,并且当包装25000打开时,钉仓25100上的RFID标签被激活。该绝缘体附接到包装25000的第一层25010和/或第二层25020或以其他方式与其相关联。当该包装处于密封构型时,绝缘体25220附接到或以其他方式连接到钉仓25100中的RFID标签,并且保持电源与RFID标签之间的电路打开。绝缘体25220与RFID标签之间的接合部防止电源激活RFID标签,并且RFID标签无法发射信号。当临床医生通过剥离第一层25010来破坏包装25000的密封时,例如将绝缘体25220与RFID标签断开或以其他方式分离时,电源与RFID标签之间的电路闭合。此时,RFID标签通电并且开始发射信号。
在各种情况下,RFID系统25200还包括转发器。该转发器被配置为从RFID扫描器接收第一信号。在各种情况下,来自RFID扫描器的第一信号使转发器充分通电,以便于转发器与RFID标签通信。在各种情况下,转发器在从RFID扫描器接收第一信号之前通电。无论如何,转发器被配置为在听到或以其他方式接收到来自RFID扫描器的第一信号时自动向RFID标签发射第二信号。RFID标签的电源在接收到来自转发器的第二信号时使RFID标签通电,并且RFID标签能够通过向RFID扫描器发射第三信号来响应RFID扫描器的第一信号。转发器保持RFID标签25210的电池寿命,直到例如RFID标签25210处于RFID扫描器的范围内。
如本文更详细地描述的,使临床医生能够验证与特定外科器械一起使用和/或在特定外科手术期间使用的钉仓的相容性是有价值的。出于各种原因,使临床医生能够确保外科钉仓先前尚未使用和/或未被篡改也是有意义的。临床医生还可能希望确认例如外科钉仓未被污染,钉保持构件尚未被移除,和/或击发构件诸如滑动件定位在仓体中。
图81至图83示出了钉仓组件26000。钉仓组件26000包括钉仓26100,和附接到钉仓26100的钉保持构件或保持器26200。保持器26200定位在钉仓26100旁边以有助于钉仓26100附接到外科器械和/或将钉保持在钉仓26100中的其相应钉腔内。保持器26200包括纵向突出部26210,该纵向突出部被构造成能够由限定在钉仓26100中的细长狭槽接收。纵向突出部26210从保持器26200的底表面26206突出并且从保持器26200的近侧端部26202朝向保持器26200的远侧端部26204延伸。保持器26200还包括一组近侧外部突出部26240和一组远侧外部突出部26220。外部突出部26220、26240被构造成能够环绕钉仓26100的侧壁26102的一部分。纵向突出部26210和外部突出部26220、26240用于例如将保持器26200保持到钉仓26100。保持器26200包括从远侧端部26204延伸的拇指突出部26230,以便于例如从钉仓26100移除保持器26200。
当保持器26200附接到钉仓26100时,保持器26200的底表面26206位于钉仓26100的平台表面26106旁边。在各种情况下,底表面26206不接触钉仓26100的平台表面26106,直到向固定器25200的顶部施加推力为止。在其他情况下,底表面20206与平台表面26106接触。为了从钉仓26100移除保持器26200,并且因此有助于将钉仓26100附接到外科器械,临床医生将拇指突出部26230在远离钉仓26100的方向上拉动或提起。保持器26200由诸如例如塑料的材料制成,该材料向保持器26200提供一定程度的柔性。当拇指突出部26230被提离钉仓26100时,外部突出部26220、26240提供反向力以努力维持保持器26200与钉仓26100之间的连接。为了移除保持器26200,临床医生必须对拇指突出部26230施加足够强以克服由外部突出部26220、26240产生的反向保持力的力。当拇指突出部26230被拉离钉仓26100时,保持器26200开始挠曲和/或弯曲,保持器26200的此类弯曲可用于停用RFID标签,如下所述。
保持器26200还包括RFID标签26250。RFID标签26250包括存储关于钉仓组件26000的信息的芯片,诸如例如微芯片。如图81至图83所示,RFID标签26250被模制到保持器26200中。然而,RFID标签26250可通过任何合适的方法嵌入在保持器26200内、安装到该保持器和/或附接到该保持器。在所描绘的实施方案中,RFID标签26250被模制到纵向突出部26210的远侧部分中。RFID标签26250位于保持器26200内的结构薄弱位置处。该结构薄弱位置可以是保持器26200的响应于拇指突出部26230的向上拉动和/或从钉仓26100移除保持器26200而弯曲和/或挠曲的任何部分。RFID标签26250以在保持器移除过程期间促进RFID标签26250的物理破坏的方式和位置附连到保持器26200。RFID标签26250的第一端部26252附接到保持器26200的第一部分26212,并且RFID标签26250的第二端部26254附接到保持器26200的第二部分26214。随着保持器26200开始响应于在拇指突出部26230上向上拉动而弯曲,保持器26200的第一部分26212和保持器的第二部分26214彼此挠曲分开。RFID标签26250的第一端部26252被保持器26200的第一部分26212拉动,并且RFID标签26250的第二端部26254被保持器26200的第二部分26214沿相反方向拉动。RFID标签26250由于该拉伸和/或挠曲被拉开和/或以其他方式破坏。RFID标签26250是脆弱、易碎和/或易损的,并且不被构造成能够明显拉伸。设想RFID标签26250可定位在保持器26200上的在保持器26200从钉仓26100移除过程期间经历足够弯曲和挠曲以引起RFID标签26250的破坏的任何合适的位置处。RFID标签26250可采用使RFID标签26250在保持器26200从钉仓26100移除期间/之后不可操作的任何合适的方式附连到保持器26200。在各种实施方案中,RFID标签26250可在该移除过程中从保持器26200分离或脱离。
在各种情况下,破坏外科系统的部件是不期望的。然而,对保持器26200中的RFID标签26250的破坏防止临床医生重复使用具有不相容或换句话说不适当的钉仓的保持器26200。在启用外科器械的至少一个操作参数之前,外科器械的控制器必须从保持器26200上的RFID标签26250接收信号。这种信号向控制器指示保持器26200保持连接到钉仓26100。在各种情况下,该信号还可指示钉仓26100与外科器械相容或不相容。在没有接收到该信号和/或接收到不相容信号的情况下,外科器械的各种功能不可用。在各种情况下,并且如下所述,保持器26200中的RFID标签26250必须失去利用RFID扫描器发送和/或发射信号的能力。RFID标签26250可通过RFID标签26250被物理破坏和/或定位在RFID扫描器范围之外而失去通信的能力。无论如何,RFID标签26250不能与RFID扫描器通信向外科器械的控制器表明保持器26200不再连接到钉仓26100。持器26200上的RFID标签26250的物理破坏确保临床医生无法在不相容的钉仓上重复使用保持器26200。在各种情况下,钉仓26100包括在RFID扫描器的通信范围内的RFID标签。当控制器接收从钉仓RFID标签而不是保持器RFID标签26250检测到的信息时,控制器被配置为识别钉仓26100保持附接到外科器械,但是保持器26200被移除。
保持器26200中的RFID标签26250提供用于外科器械的闭锁件。如果存储在RFID标签26250上的信息未被外科器械的控制器接收,则外科器械将不会执行钉击发行程。在各种情况下,当RFID标签26250仍与RFID扫描器通信时,外科器械将不执行钉击发行程。这种闭锁件防止外科器械在保持器26200仍然附接的情况下钉仓26100已经被不适当地安置在外科器械中时执行钉击发行程。
在各种情况下,钉仓26100和保持器26200被制造商组装到钉仓组件26000中。在这种情况下,仅当钉仓26100已经插入已用于与外科器械一起使用,钉仓组件26000已经被篡改,以及/或者存在抑制适当附接的制造缺陷时,保持器26200才会从钉仓26100移除。RFID标签26250的分离和/或物理破坏防止例如保持器26200被放置在已使用的和/或换句话说不适当的钉仓26100上。
如本文更详细地提及的,外科器械可包括配置为与附近RFID标签通信的RFID扫描器。RFID扫描器包括被配置为发射无线电信号的扫描器天线。该无线电信号激活位于RFID扫描器的预定范围内的RFID标签。然后RFID扫描器接收从RFID标签“反弹回来”的一个或多个响应信号。在各种情况下,该一个或多个响应信号包括与询问信号相同的信号。在各种情况下,该一个或多个响应信号包括来自询问信号的修改信号。在各种情况下,RFID扫描器包括读取能力和写入能力。RFID扫描器上的软件然后能够将所收集的信息从RFID标签传递到控制器以用于进一步解释。控制器可定位在外科器械、远程控制台中或定位在任何合适的位置。RFID扫描器和/或控制器可包括所存储的对应于与特定外科器械相容和/或在特定外科手术期间使用的外科缝合组件的一组信息。
更具体地,外科系统包括被配置为与模制到保持器26200中的RFID标签26250交互的RFID扫描器。RFID扫描器可存在于各个位置。例如,RFID扫描器可位于钉仓26100中。在各种情况下,RFID扫描器可位于外科器械的端部执行器的钳口中,在外科系统内的另选位置,和/或当保持器26200适当地附接到钉仓26100时允许RFID标签26250与RFID扫描器之间的通信的任何其他合适的位置。RFID扫描器和/或RFID标签26250通电,使得其发射的信号只能在有限的半径内被检测到。RFID扫描器和RFID标签26250在保持器26200附接到钉仓26100时足够接近以便于通信,但是在保持器26200从钉仓26100移除时不足够接近以使得无法通信。也就是说,当保持器26200从钉仓26100移除时,RFID标签26250通过例如物理破坏或分离而不可操作。当RFID标签26250不可操作时,不回答由RFID扫描器发送的信号(诸如询问信号)。
如果具有已破坏的RFID标签26250的已使用的保持器附接到另一钉仓,则RFID扫描器和已破坏的RFID标签26250将无法通信。在此类情况下,外科器械的钉仓验证系统将无法允许外科器械执行钉击发行程。如果RFID扫描器接收到在存储的一组相容缝合组件内未发现的询问信号的响应,则外科器械的控制器被编程为将错误传达给临床医生。同样,如果RFID扫描器未接收到对询问信号的响应,则外科器械的控制器被编程为将错误传达给临床医生。在各种情况下,控制器检测到错误可使外科器械无法与特定钉仓一起使用。在各种情况下,所检测到的错误可阻止外科器械执行钉击发行程和/或组织切割行程。在各种情况下,外科器械还包括手动超控件,可激活该手动超控件以允许临床医生在紧急情况下超控任何系统闭锁件并且利用外科器械的操作功能。如上所述,控制器被配置为提醒临床医生已经检测到错误。可通过各种形式的反馈来传送这种提醒,包括例如触觉反馈、声音反馈和/或视觉反馈。在至少一种情况下,该反馈包括音频反馈,并且外科器械可包括当检测到错误时发出声音诸如例如蜂鸣声的扬声器。在某些情况下,该反馈包括视觉反馈,并且外科器械可包括发光二极管(LED),例如,该LED在检测到错误时闪烁。在各种情况下,该反馈包括触觉反馈,并且外科器械可包括电动马达,该电动马达包括在检测到错误时振动的偏心元件。该提醒可以是特定的或通用的。例如,该提醒可具体地指明无法检测到保持器26200上的RFID标签26250,或者该提醒可具体地指明RFID标签26250包括表示不相容和/或有缺陷的钉仓组件26000的信息。
图84示出了钉仓组件27000。该钉仓组件包括钉仓27100。钉仓27100包括钉仓主体,该钉仓主体包括基部27104、平台表面27106,和在基部27104与平台表面27106之间延伸的侧壁27102。细长狭槽27110限定在钉仓27100中并且从近侧端部27101朝向钉仓27100的远侧端部延伸。细长狭槽27100的尺寸被设定成促进击发和/或切割构件诸如动件27125在钉击发行程期间从中经过。通道27120限定在钉仓27100内,这些通道从近侧端部27101朝向钉仓27100的远侧端部延伸。每个通道27120被构造成能够接收滑动件27125的斜坡。钉仓27100还包括限定在仓体中的几排纵向钉腔,和可移除地储存在钉腔中的钉。在钉击发行程期间,滑动件27125从钉仓27100喷射钉。
钉仓组件27000还包括RFID系统27200。RFID系统27200包括安装到钉仓组件27000的RFID标签27250和安装到外科器械的RFID扫描器27300。RFID标签27250包括存储关于钉仓组件27000的信息的芯片,诸如例如微芯片。在各种情况下,该芯片包括钉仓27100的基本识别号。在各种情况下,该芯片包括另外的信息,诸如例如制造数据、运输数据和/或相容性数据。RFID标签27250还包括被配置为从RFID扫描器27300接收询问信号和将响应信号发送到该RFID扫描器的无线电天线。RFID扫描器27300被配置为当钉仓27100安置在外科器械中时与RFID标签27250通信。RFID扫描器27300包括扫描器天线,该扫描器天线被配置为例如发射和接收无线电信号。也就是说,RFID系统27200可使用任何合适的频率。由于电磁波在各种频率下具有不同的表现,所以基于特定应用来选择所需频率。在各种情况下,RFID系统27200可利用低频、高频和/或超高频。无线电信号激活位于RFID扫描器27300的预定范围内的RFID标签。然后RFID扫描器27300接收从RFID标签“反弹回来”的一个或多个响应信号。在各种情况下,该一个或多个响应信号包括与询问信号相同的信号。在各种情况下,该一个或多个响应信号包括来自询问信号的修改信号。在各种情况下,RFID扫描器27300包括读取能力和写入能力。RFID扫描器27300上的软件然后能够将所收集的信息从RFID标签传递到控制器以用于进一步解释。控制器可定位在外科器械中、远程控制台上或定位在任何合适的位置。RFID扫描器和/或控制器可包括所存储的对应于与特定外科器械和/或特定外科手术相容的外科缝合组件的一组信息。
如上所述,外科器械中的RFID扫描器27300被配置为与定位在钉仓27100上的RFID标签27250交互。如图84所示,RFID标签27250附连到钉仓27100的侧壁27102中的一个侧壁,并且RFID扫描器27300安装在外科器械内。如上所述,RFID标签27250包括无线电天线27252和芯片27254。在所描绘的实施方案中,无线电天线27252和芯片27254定位在RFID标签27250内。在各种情况下,无线电天线27252定位在RFID标签27250的外表面上。当钉仓27100被安置在外科器械中时,RFID标签27250定位成与RFID扫描器27300相距距离“D”。值得注意的是,距离“D”可以是例如钉仓27100的长度的大约1/4、钉仓27100的长度的1/3、或钉仓27100的长度的1/2。在所描绘的实施方案中,RFID标签的无线电天线和RFID扫描器的天线的通信范围27255跨越例如大约1厘米(cm)。距离“D”大于1cm,并且因此在RFID扫描器27300与RFID标签27250的无线电天线27252之间的通信范围27255之外。因此,RFID标签27250无法接收询问信号并且也不会对来自RFID扫描器27300的询问信号进行响应。
为了促进与RFID扫描器27300的通信,图84中所描绘的RFID标签系统27200还包括与RFID标签27250通信的加长天线27260。加长天线27260用于例如与无线电天线27252相比扩大RFID标签27250的通信范围。加长天线27260沿着侧壁27102延伸,附接到该侧壁并且跨越钉仓27100的基部27104的一部分。加长天线27260的至少一部分横穿细长狭槽27110。在所描绘的实施方案中,加长天线27260的通信范围27265跨越例如大约2厘米(cm)。如前所述,RFID扫描器27300定位在距RFID标签27250的距离“D”处。虽然距离“D”大于1cm,但是距离“D”小于2cm,并且因此在加长天线27260和RFID扫描器天线的通信范围27265的内。利用加长天线27260,RFID标签27250能够接收询问信号并且对来自RFID扫描器27300的询问信号进行响应。然而,如果没有加长天线27260,则RFID标签27250可能不与RFID扫描器27300通信。RFID标签27250和加长天线27260可采用任何合适的方式附接到钉仓27100,包括例如安装在钉仓27100上、嵌入在该钉仓中和/或固定到该钉仓。此外,RFID标签27250可定位在钉仓27100上的任何合适的位置处,诸如例如在基部27104和/或平台表面27106上。
如前所述,加长天线27260的至少一部分横穿钉仓27100的细长狭槽27110。在钉击发行程期间,组织切割和/或钉击发构件被构造成能够在钉击发行程期间纵向平移通过细长狭槽27110,并且在此过程中横切或以其他方式破坏加长天线27260。加长天线27260的横穿细长狭槽27110的部分定位在最近侧钉腔近侧的位置处。因此,加长天线27260仅在钉击发行程开始之前工作。组织切割和/或钉击发构件的任何导致钉的击发的远侧移动使加长天线27260无法操作。可采用任何合适的方式使加长天线27260无法操作。例如,加长天线27260可被组织切割构件切割,并且因此被物理地破坏。在各种情况下,加长天线27260可响应于由组织切割和钉击发构件施加的力而从RFID标签27250和/或钉仓27100分离。值得注意的是,钉击发行程不会损坏RFID标签27250的无线电天线27252。然而,无线电天线27252的范围不足以促进RFID标签27250与RFID扫描器27300之间的通信。因此,加长天线27260的分离可改变RFID标签27250的通信范围27265,并且移除RFID标签27250与RFID扫描器27300通信的能力。
以这种方式破坏加长天线27260不会不利地影响外科器械的操作。换句话说,加长天线27260直到在钉仓271000已被认证之后才被破坏。因此,可在加长天线27260已被破坏之后执行钉击发行程。也就是说,一旦加长天线27260已被破坏并且钉仓27100已经从外科器械被移除,将钉仓27100重新安置在外科器械中将不会重新认证钉仓27100,因为RFID扫描器不会再与RFID标签27250通信。这样的布置用作用过的仓闭锁件等。
如上所述,在加长天线27260不可操作的情况下,RFID扫描器27300不接收对其询问信号的响应。当RFID扫描器27300未接收到对询问信号的响应时,外科器械的控制器被编程为识别错误。在RFID扫描器27300接收到对其询问信号的不能被识别和/或不表示相容的钉仓组件27000的响应的情况下,外科器械的控制器也被编程为识别错误。在各种情况下,控制器检测到错误可使外科器械无法与钉仓组件27000一起使用。在各种情况下,所检测到的错误可阻止当钉仓组件27000附接到外科器械时外科器械执行钉击发行程和/或组织切割行程。可激活手动超控件以允许临床医生在紧急情况下超控任何系统闭锁件并且利用外科器械的操作功能。在各种情况下,控制器被配置为提醒临床医生已经检测到错误。可通过各种形式的反馈来传送这种提醒,包括例如触觉反馈、声音反馈和/或视觉反馈。该提醒可以是特定的或通用的。例如,该提醒可具体地指明无法检测到RFID标签27250,或者该提醒可具体地指明RFID标签27250包括表示不相容和/或有缺陷的钉仓组件27000的信息。
加长天线27260的横穿细长狭槽27110的部分可位于沿细长狭槽27110的任何合适的位置处。例如,加长天线27260可在与最远侧钉腔对准或略微近侧的位置横穿细长狭槽27110。在这样的实施方案中,当组织切割和钉击发行程完成时,使加长天线27260无法操作。当RFID扫描器27300在这种情况下无法与RFID标签27250通信时,临床医生将能够例如确认整个钉击发行程完成。此外,RFID标签27250可定位在钉仓27100上的任何合适的位置处,诸如例如在钉仓27100的基部27104和/或平台表面27106上。
在各种情况下,加长天线27260包括被构造成能够横穿钉仓27100的细长狭槽27110的第一天线,和未横穿钉仓27100的细长狭槽27110的第二天线。换句话说,在钉击发行程期间,第二天线不会被击发构件横切。当第一天线被击发构件横切时,RFID标签27250的通信范围缩小。然而,可使用在钉击发行程期间未被击发构件横切的第一天线来改善RFID标签27250的通信范围。
图85示出了可结合到外科器械诸如例如本文所讨论的外科器械400中的示例性RFID系统28200。RFID系统28200可集成到例如钉仓、端部执行器钳口和/或外科器械内的任何其他合适的位置中。RFID系统28200包括RFID标签28250和RFID扫描器系统28300。RFID标签28250的结构和功能类似于本文所讨论的RFID标签,诸如例如RFID标签26250、27250。RFID扫描器系统28300包括第一RFID扫描器28310和第二RFID扫描器28320。RFID扫描器28310、28320的功能类似于本文讨论的其他RFID扫描器,诸如例如RFID扫描器27300。
RFID标签28250包括存储关于外科系统内的可替换部件的信息的芯片,诸如例如微芯片。在各种情况下,该芯片包括钉仓的识别号。在各种情况下,该芯片包括另外的信息,诸如例如钉仓的制造数据、运输数据和/或其他相容性数据。RFID标签28250还包括被配置为从RFID扫描器28310、28320中的一者和/或两者接收询问信号的无线电天线。
每个RFID扫描器28310、28320包括被配置为发射无线电信号的扫描器天线。该无线电信号激活位于RFID扫描器28310的预定范围内的RFID标签28250。然后RFID扫描器28310接收从RFID标签28250“反弹回来”的一个或多个响应信号。在各种情况下,该一个或多个响应信号包括与询问信号相同的信号。在各种情况下,该一个或多个响应信号包括来自询问信号的修改信号。第二RFID扫描器28320还被配置为向RFID标签28250发射信号。
在各种情况下,RFID扫描器28310包括读取能力和写入能力。RFID扫描器28310上的软件然后能够将所收集的信息从RFID标签28250传递到控制器以用于进一步解释。控制器可定位在外科器械中、远程控制台上或定位在任何合适的位置。也可采用这种方式使用第二RFID扫描器28320。
RFID扫描器系统28300包括柔性电路,其中该柔性电路包括第一层和第二层。第一层充当第一RFID扫描器28310,并且第二层充当第二RFID扫描器28320。RFID扫描器28310、28320还包括RF放大器,该RF放大器确定要由RFID扫描器28310、28320发射的信号的功率并且将询问信号放大到所需的功率水平。当通电时,第一层28310被配置为利用大约1瓦特的功率或更小的功率来发射信号2815。当通电时,第二层28320被配置为利用超过1瓦特的功率来发送信号28325。实际上,该放大器与外科器械的控制器通信,并且如下文更详细地描述,可利用远远超过1瓦特的功率来发射第二RFID扫描器28320的信号。
在钉击发行程之前,第一RFID扫描器28310通电。如图86所示,第一RFID扫描器28310向RFID标签28250发送询问信号28315。RFID标签28250使用RFID标签28250的无线电天线接收该能量或询问信号28315。所接收的能量行进通过标签的天线,并且所接收的能量的一部分用于激活芯片而且基于从第一RFID扫描器28310接收的命令来准备数据的传输。芯片的激活允许芯片利用存储在RFID标签28250中的信息调制所接收的能量,并且将剩余能量以响应信号28255的形式“反射”回去。芯片将与询问信号相同和/或不同的响应信号28255发射回RFID扫描器28310。响应信号28255由第一RFID扫描器的天线接收,以便第一RFID扫描器28310恢复存储在RFID标签28250上的信息。
在钉击发行程开始之后,除了第一RFID扫描器28310之外和/或代替该第一RFID扫描器,第二RFID扫描器28320通电。如图87所示,第一RFID扫描器28310和第二RFID扫描器28320两者同时向RFID标签28250发送询问信号28315、28325。RFID标签28250使用RFID标签28250的无线电天线从两个询问信号28315、28325接收能量。所接收的能量总计例如大约2瓦特的功率,并且超过了RFID标签28250的例如1瓦特的操作功率阈值。当RFID标签28250从第一RFID扫描器28310和第二RFID扫描器28320两者接收到询问信号28315、28325时无法操作。在各种情况下,RFID标签28250由于超过了操作功率阈值而过热。热量增加可例如使RFID标签内保险丝燃烧,熔化RFID标签的一部分,和/或以其他方式使RFID标签28250无法操作。
以这种方式破坏RFID标签28250不会不利地影响外科器械的操作。换句话说,直到在钉仓已被外科器械认证之后才会发生RFID标签28250的破坏。相反,一旦钉仓已被认证,外科器械就可用于执行钉击发行程以及其他功能。在缝合钉击发行程之后和/或从外科器械移除钉仓之后,外科器械无法重新认证钉仓,并且钉仓因此不能重复使用。该系统用作用过的仓闭锁件等。
无论如何,在不可操作构型下,RFID标签28250无法从RFID扫描器接收信号和/或将信号发射到RFID扫描器。当第一RFID扫描器28310未接收到对其询问信号28315的响应时,外科器械的控制器被配置为将错误传达给临床医生。在第一RFID扫描器28310接收到对其询问信号28315的不能被识别和/或不表示相容的钉仓组件的响应的情况下,外科器械的控制器也被编程为将错误传达给临床医生。在各种情况下,从控制器传送所检测到的错误可使外科器械在钉仓组件附接时无法操作。在各种情况下,所检测到的错误可以阻止当钉仓组件附接时外科器械执行钉击发行程和/或组织切割行程。可激活手动超控件以允许临床医生在紧急情况下超控任何系统闭锁件并且利用外科器械的操作功能。在各种情况下,控制器被配置为提醒临床医生已经检测到错误。可通过各种形式的反馈来传送这种提醒,包括例如触觉反馈、声音反馈和/或视觉反馈。该提醒可以是特定的或通用的。例如,该提醒可具体地指明无法检测到RFID标签28250,或者该提醒可具体地指明RFID标签28250包括表示不相容和/或有缺陷的钉仓组件的信息。
如上所述,第一RFID扫描器28310可用于与RFID标签28250通信,并且第一RFID扫描器28310和第二RFID扫描器28320的组合操作可用于破坏RFID标签28250。另选地,第一RFID扫描器28310可用于与RFID标签28250通信,并且第二RFID扫描器28320可用于破坏RFID标签28250。在该实施方案中,第一RFID扫描器28310使用低于阈值的功率,并且第二RFID扫描器28320使用高于该阈值的功率。另外,另选地,可不使用第二RFID扫描器,因为通信和破坏功能两者可由单个扫描器执行。在至少一个这种情况下,信号放大器用于发射低于功率阈值的信号以进行通信,并且发射高于该功率阈值的信号以进行破坏。
图88至图89A示出了仓闭锁系统29000。仓闭锁系统29000被构造成能够当检测到不相容和/或用过的钉仓时阻止外科器械执行钉击发行程。当检测到未用过的相容的钉仓时,外科器械的控制器允许执行钉击发行程。一个这样的相容的钉仓包括例如钉仓29100。
钉仓29100包括仓体,该仓体包括仓平台29106、基部29104,和在仓平台29106与基部29104之间延伸的侧壁29108。仓体中限定多个钉腔29107。钉腔29107以纵向排布置,并且钉可移除地支撑在每个钉腔29107内。钉仓29100还包括近侧端部29102和远侧端部。细长狭槽29110从近侧端部29102朝向远侧端部延伸,并且被构造成能够在钉击发行程期间接收击发构件29210。钉仓29100还包括楔形滑动件29125和限定在仓体内的通道29120。楔形滑动件29125被构造成能够在钉击发行程期间将钉驱动到仓体之外并且朝向砧座。通道29120被构造成能够在楔形滑动件29125在钉击发行程期间平移经过钉仓29100时接收楔形滑动件29125的斜坡。在通道29120的内侧形成止动件以与楔形滑动件29125的斜坡介接并且控制楔形滑动件29125在通道29120内的侧向位置。在至少一种情况下,肋可用于将楔形滑动件29125可释放地保持在近侧未击发位置。
钉仓29100还包括RFID标签29250。RFID标签29250包括存储关于钉仓29100的信息的芯片,诸如例如微芯片。在各种情况下,该芯片包括基本识别号。在各种情况下,该芯片包括另外的信息,诸如例如制造数据、运输数据和/或相容性数据。RFID标签26250还包括被配置为从RFID扫描器接收询问信号的无线电天线。如图88和图89所示,RFID标签29250附连到钉仓29100的侧壁29108中的一个侧壁。然而,可设想RFID标签29250可采用任何合适的方式和/或在任何合适的位置嵌入钉仓29100内和/或附接到钉仓29100。
该外科系统还包括RFID扫描器。RFID扫描器包括被配置为发射无线电信号的扫描器天线。该无线电信号激活位于RFID扫描器的预定传输范围内的RFID标签。然后RFID扫描器接收从RFID标签“反弹回来”的一个或多个响应信号29255。在各种情况下,该一个或多个响应信号包括与询问信号相同的信号。在各种情况下,该一个或多个响应信号包括来自询问信号的修改信号。RFID扫描器可定位在各种位置,诸如例如钉仓29100、外科器械的端部执行器和/或相对于外科器械远程定位的控制台。换句话说,RFID扫描器可定位在当钉仓29100被安置到外科器械的端部执行器中时和/或一旦钉仓29100被安置在外科器械的端部执行器中时允许RFID扫描器与RFID标签29250通信的任何合适的位置。在各种情况下,RFID扫描器包括读取能力和写入能力。RFID扫描器上的软件能够将所收集的信息29255从RFID标签29250传递到控制器以用于进一步解释。控制器可定位在外科器械中或任何合适的位置。RFID扫描器和/或控制器可包括所存储的对应于与特定外科器械相容和/或在特定外科手术期间使用的钉仓的一组信息。
基于从RFID标签29250收集的信息29255,控制器可维持、激活和/或停用仓闭锁组件,诸如例如仓闭锁组件29000。仓闭锁组件29000包括闭锁杆29300。闭锁杆29300包括近侧端部29302和远侧端部29304。闭锁杆29300的远侧端部29304被构造成能够当钉仓29100安置在端部执行器的钳口中时与楔形滑动件29125介接。闭锁杆29300的尺寸被设定成配合在形成于仓体中的通道29120中的一个通道内。闭锁杆29300的近侧端部29302包括侧向突出部或凸缘29310。闭锁杆29300的近侧端部29302与钉击发驱动装置的击发杆29200接合,使得闭锁杆29300和击发杆29200一起移动。击发杆29200包括沟槽29225,该沟槽接收闭锁杆29300的侧向突出部29310。
仓闭锁组件29000还包括阻挡螺栓组件29400。在所描绘的实施方案中,阻挡螺栓组件29400包括螺线管。阻挡螺栓组件29400包括锁定螺栓29410、弹性构件29420和感应线圈29430。在图88至图89A中所描绘的实施方案中,弹性构件29420是弹簧,但是可使用任何弹性构件。阻挡螺栓组件29400能够被构造成处于解锁构型和锁定构型。锁定螺栓29410和弹性构件29420定位在阻挡螺栓组件29400的外壳29405中。弹性构件29240将锁定螺栓29410偏置成其锁定构型。在锁定构型中,锁定螺栓29410的一部分延伸到外壳29405之外。在解锁构型中,锁定螺栓29410整个定位在外壳29405内。
当控制器已经检测到相容的钉仓29100时,阻挡螺栓组件29400被控制器置于解锁构型。当RFID标签29250发射对应于RFID扫描器和/或控制器内所存储的一组信息的信号29255时,以及/或者当临床医生超控控制器时,检测到相容的钉仓29100。在此类情况下,控制器被配置为激活阻挡螺栓组件29400的感应线圈29430。控制器将电压源施加到线圈29430以激活线圈29430。激活感应线圈29430产生磁场,该磁场将锁定螺栓29410拉到外壳29405中。为此,锁定螺栓29410由铁、镍和/或任何合适的磁性材料构成。也就是说,弹性构件29420由于锁定螺栓29410的移动而被压缩,并且因此弹性构件29240阻挠锁定螺栓29410的移动。无论如何,锁定螺栓29410回缩足够的量以离开闭锁杆29300的路径。此时可执行钉击发行程。如果钉仓29100从外科器械移除,则控制器将停用感应线圈29430,从而允许弹性构件29240使锁定螺栓29410重新伸长。
当钉仓29100被安置到端部执行器的钳口中时,除上述之外,闭锁杆29300的远侧端部29304变得与钉仓29100的滑动件29125接触。如果锁定螺栓29410已经回缩,则当临床医生尝试将钉仓29100安置在钳口内时,闭锁杆29300的近侧端部29302被钉仓29100的滑动件29125向近侧推动。在此类情况下,闭锁杆29300被构造成能够在近侧方向上自由平移。缺乏抵抗闭锁杆29300的近侧移动的阻力允许闭锁杆29300移动而不会使钉仓29100中的楔形滑动件29125移位。换句话说,通道29120内的止动件作用在楔形滑动件29125上的保持力足以将楔形滑动件29125保持在其当前位置,而当钉仓29100被安置在外科器械中时推动闭锁杆29300。
如上所述,当已经检测到不相容的钉仓29100'时,阻挡螺栓组件29400处于锁定构型。如图89所示,当RFID标签29250发射不对应于RFID扫描器和/或控制器内所存储的一组信息的信号29255’时,检测到不相容的钉仓29100'。在各种情况下,当RFID扫描器无法检测来自RFID标签的信号时,将钉仓29100'视为与外科器械的控制器不相容。当发射的信号29255'或缺乏信号指示不相容的钉仓29100'时,阻挡螺栓组件29400的感应线圈29430未被控制器激活。在不激活感应线圈29430的情况下,偏置构件29420保持锁定螺栓29410的一部分延伸到外壳29405之外。当钉仓29100’被安置到端部执行器的钳口中并且锁定螺栓29410伸长时,闭锁杆29300的远侧端部29304变得与钉仓29100'的滑动件29125接触。闭锁杆29300被阻止在近侧方向上平移,因为锁定螺栓29410处于其路径中。在此类情况下,由锁定螺栓29410抵靠闭锁杆29300提供的阻力超过由将楔形滑动件29125保持在适当位置的通道29120中的止动件提供的保持力。因此,当钉仓29100’被安置并且锁定螺栓29410未回缩时,楔形滑动件29125从其未击发位置向远侧移位。楔形滑动件29125从其未击发位置的远侧移动使钉仓29100’被用掉,即使没有钉从钉仓29100’击发。在以下这些公开内容全文以引用方式并入本文的美国专利中公开的击发闭锁系统将机械地防止在此类情况下执行钉击发行程:2006年12月5日公布的名称为“SURGICAL STAPLING INSTRUMENT HAVING A FIRINGLOCKOUT FOR AN UNCLOSED ANVIL”的美国专利7,143,923;2006年5月16日公布的名称为“SURGICAL STAPLING INSTRUMENT HAVING A SINGLE LOCKOUT MECHANISM FORPREVENTION OF FIRING”的美国专利7044352;2006年2月21日公布的名称为“SURGICALSTAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRING SYSTEMS”的美国专利7000818;2006年1月24日公布的名称为“SURGICAL STAPLING INSTRUMENT HAVING ASPENT CARTRIDGE LOCKOUT”的美国专利6988649;和2005年12月27日公布的美国专利No.6,978,921,“SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRINGMECHANISM”。
图90示出了用于控制仓闭锁组件29000的马达控制电路30000。马达控制电路30000的各种细节在名称为“MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENT”的美国专利申请公布2010/0075474中更详细地描述,该专利申请的公开内容全文以引用方式并入。电池或其他合适的电源30064为电动马达30065供电。当临床医生最初拉动外科器械的击发触发器时,运转马达(或击发)开关30110闭合。当运转马达开关30110闭合时,安全开关闭合,并且闭锁开关打开,电流流过安全开关,流过闭锁指示器30244,并且到达马达30065。当达到钉击发行程的末尾时,切换行程结束或方向开关30130,使马达30065的方向反转。电路30000还可包括手动返回开关30348。如果击发构件(诸如击发构件29210)仅部分被击发,则临床医生可手动翻转此开关30348。切换手动返回开关30348使马达30065反向旋转,从而使击发构件返回到其初始位置或原始位置。
马达控制电路30000还包括仓闭锁开关30300。当控制器30310通过来自RFID标签(诸如RFID标签29250)的接收信号确定相容的钉仓被安置在端部执行器中时,感应线圈30320通电。感应线圈30320的通电使仓闭锁开关30300闭合,并且允许相容的钉仓被安置在端部执行器内而不会使该钉仓的楔形滑动件移位。当控制器30310通过来自RFID标签(诸如RFID标签29250)的接收信号确定不相容的钉仓被安置在端部执行器中时,感应线圈30320不通电。未激活的感应线圈30320'允许仓闭锁开关30300保持打开。然后仓闭锁件(诸如仓闭锁件29000)引起楔形滑动件在该不相容的外科仓内的远侧移位。然后外科器械无法在不相容的外科仓附接时执行钉击发行程。
各种外科器械由需要在外科手术开始之前和/或期间替换的可替换部件组成。例如,外科缝合器械(诸如外科缝合器械400)包括可替换钉仓。临床医生可能处于各种理由而期望和/或需要替换钉仓,诸如例如所执行的外科手术的类型、在外科手术期间处理的组织的厚度和/或钉仓的状态。钉仓的状态对应于例如钉仓是否被用过,即,来自钉仓内的一个或多个钉是否在缝合钉击发行程期间射出。
如本文更详细地描述的,可在整个外科系统中定位各种识别系统,诸如例如RFID标签、QR码和/或条形码。例如,并且如图91所示,第一RFID标签31560a定位在钉仓31500的仓体31510上,第二RFID标签31560b定位在钉仓31500的楔形滑动件31550上,并且第三RFID标签31560c定位在钉仓31500的保持器31570上。每个RFID标签包括存储与钉仓组件的状态、钉仓识别和/或钉仓组件与特定外科器械的相容性等有关的信息的芯片。为了确保患者安全性和外科外科系统内部件的正确组装等目的,存储在每个芯片上的信息被加密。对芯片上的信息的加密使得只有授权方才能访问所存储的信息,而未被授权方不能访问这些信息。换句话说,如果存储在芯片上的信息无法被解密,则外科系统将无法组装不相容的组装部件,并且/或者当附接不相容的组装部件时,外科系统的一个或多个操作参数将不可用和/或被修改。加密密钥存储在外科系统的控制器和/或外部存储介质内,以通过一个或多个RFID扫描器解密从RFID标签收集的信息。在各种情况下,所有RFID标签都包括加密信息。在其他情况下,RFID标签中只有一个包括加密信息,诸如例如定位在钉仓上的RFID标签。然而,设想RFID标签的任何合适组合可包括具有加密信息的芯片。在各种情况下,一个或多个加密密钥存储在外科器械上的存储器中,然而也设想任何合适的存储位置。
存储在钉仓的RFID标签上的数据可在钉仓的制造过程期间使用加密协议来加密。可加密该信息以例如防止在未经授权和/或具有较差部件的情况下使用被复制的钉仓。钉仓的此类未经授权的复制可能不会被制造为具有与相容的钉仓相同的规格和/或尺寸。如果不相容的钉仓与外科器械一起使用,则不相容的钉仓可能不会采用与相容的钉仓相同的方式来执行手术功能,从而当不相容的钉仓与外科器械一起使用时使患者暴露于增加的风险之中。
在制造过程期间,RFID扫描器发射第一询问信号以询问钉仓31500的第一RFID标签31560a。第一RFID标签31560a响应于第一询问信号而发射第一信号31580a。第一响应信号31580a包括与钉仓31500相关的未加密或未保护数据。此类数据可包括例如制造数据和/或仓识别数据。RFID扫描器发射第二询问信号和第三询问信号以分别询问第二RFID标签31560b和第三RFID标签31560c。第二RFID标签31560b响应于第二询问信号而发射第二信号31580b,并且第三RFID标签31560c响应于第三询问信号而发射第三信号31580c。第二响应信号31580b和第三响应信号31580c分别包括与楔形滑动件31550和保持器31570有关的未加密或未保护数据。此类数据可包括例如制造数据和/或识别数据。
RFID扫描器将响应信号31580a、31580b、31580c发射到制造控制器31100。制造控制器31100访问云存储介质31150,以例如对所接收的数据进行加密。云存储介质31150包括被配置为加密响应信号31580a、31580b、31580c中所包含的数据的加密协议。使用加密协议,云存储介质31150创建反映钉仓31500的具有RFID标签的各种部件的加密序列号。例如,存储在第一RFID标签31560a上的未保护数据用第一值31202加密。存储在第二RFID标签31560b上的未保护数据用第二值31204加密,并且存储在第三RFID标签31560c上的未保护数据用第三值31206加密。第一值31202、第二值31204和第三值31026被组合以形成反映钉仓31500的身份的唯一序列号31200。这种加密过程在每个所制造的钉仓上进行。还参见图63。
在云存储介质31150完成加密协议之后,制造控制器31100用加密数据重写RFID标签31560a、31560b、31560c。制造控制器31100引导RFID扫描器将第一重写信号31110a发送到第一RFID标签31560a。第一重写信号31110a用于删除存储在第一RFID标签31560a上的未保护数据,并且用新的保护数据31202替换未保护数据。RFID扫描器将第二重写信号31110b发射到第二RFID标签31560b,并且将第三重写信号31110c发射到第三RFID标签31560c。第二重写信号31110b用于删除存储在第二RFID标签31560b上的未保护数据,并且用新的保护数据31204替换未保护数据。第三重写信号31110c用于删除存储在第三RFID标签31560c上的未保护数据,并且用新的保护数据31206替换未保护数据。此时,RFID标签31560a、31560b、31560c仅包括加密数据,并且只有云存储介质31150可以通过解密协议来获得未保护的未加密数据。如上所述,RFID读取器被配置为将信号发射到RFID标签和从RFID标签接收信号。在此类情况下,RFID读取器包括读取能力和写入能力两者。
当存储在每个钉仓31500上的数据被加密时,云存储介质31150创建钉仓31500的唯一序列号31200以及相关联的加密密钥的列表31250。列表31250可实时更新和/或可在每个RFID标签31560a、31560b、31560c用加密信息编程之后创建。制造控制器31100被配置为从云存储介质31150访问唯一序列号31200的列表31250。在包装过程期间,制造控制器31100引导包装打印机31600以在用于钉仓31500的包装上打印独特的序列号31200。
当需要钉仓31500附接到外科器械时,临床医生需要扫描钉仓31500的包装。外科器械的控制器和/或手术室内的远程控制器将所扫描的包装数据传送到云存储介质31150。该远程控制器例如将所扫描的包装数据传送到云存储介质31150以用于解密。云存储介质31150对所扫描的包装数据执行解密协议,并且将所接收的数据与相容或以其他方式可接受的钉仓的列表31250进行比较。如果云存储介质31150将所扫描的包装数据识别为可以与外科器械一起使用,则云存储介质31150将批准信号传送到远程控制器。该远程控制器将批准信号传送到外科器械上的控制器,并且外科器械能够执行例如钉击发行程。如果云存储介质31150无法识别所扫描的包装数据,则云存储介质31150将错误传送到远程控制器。该远程控制器将错误传送到外科器械上的控制器,并且外科器械不能执行钉击发行程。在各种情况下,外科器械包括临床医生可以激活的超控输入,但是仅在已经充分警告临床医生钉仓未通过认证协议之后才激活。
如前所述,模块化部件的包装(诸如包装25000)包括与该包装的内容物有关的一个或多个识别系统。制造控制器和包装打印机31600使用上文所论述的加密信息创建识别系统。可使用各种技术来对包装做标记。此类技术包括例如激光印刷、移印、热敏印刷和/或芯片编程。例如,激光印刷可用于在产品包装上印刷QR码和/或条形码。芯片编程可用于改变存储在RFID系统(诸如例如RFID系统25200)内的信息。
图92示出了由外科器械的控制器操作的解密协议32000。例如,控制器使用自动递的增加密密钥来促进外科器械(诸如例如上述外科器械)的组装和/或使用。外科器械控制器包括存储器。存储器存储默认内部密钥32010,该密钥允许控制器解密第一RFID标签。第一RFID标签定位在钉仓包装上,并且第一RFID标签包括第一组加密信息。第一组加密信息只能由控制器使用默认内部密钥32010来解密。解密协议32000在第一RFID标签成功解密时发布第二内部密钥32040。如果控制器确定包装不是真实的,如果控制器无法解密存储在第一RFID标签上的信息和/或如果存储在第一RFID标签上的信息不能识别,则不发布第二内部密钥32040,并且解密协议32000不能继续下一步。RFID扫描器可重新扫描第一RFID标签,或者可扫描新的包装32020。在不继续进行解密协议32000的下一认证步骤的情况下,外科器械的控制器阻止外科器械执行缝合钉击发行程。
钉仓包括定位在仓体上的第二RFID标签,并且该第二RFID标签包括第二组加密信息。第二组加密信息只能由控制器使用第二内部密钥32040来解密。解密协议32000在第二RFID标签数据成功解密时发布第三内部密钥32070。如果控制器确定钉仓不是真实的,如果控制器无法解密存储在第二RFID标签上的信息和/或如果存储在第二RFID标签上的信息不能识别,则不发布第三内部密钥32070,并且解密协议32000不能继续下一步。RFID扫描器可重新扫描第二RFID标签,或者可扫描新的钉仓32050。在不继续进行解密协议32000的下一认证步骤的情况下,外科器械的控制器阻止外科器械执行缝合钉击发行程。
如上所述,先前包含在包装中的钉仓包括被动第二RFID标签。第二RFID标签定位在钉仓中的任何合适的位置处。临床医生可将RFID扫描器带到第二RFID标签的范围内,其中RFID扫描器发射信号以扫描32050钉仓的第二RFID标签。响应于RFID扫描器的发射信号,第二RFID标签被配置为将其加密信息发射回RFID扫描器。RFID扫描器上的软件被配置为将所传送的信息传输到控制器以使用所发布和/或解锁的内部密钥32040进行解密。一旦所接收的信息被解密,控制器就被配置为确定钉仓是否包括与外科器械相容的真实部件32060。换句话说,由第二RFID标签存储的信息允许临床医生确认包装确实包含真实的钉仓。在各种情况下,控制器还被配置为确定钉仓是否已经被篡改,先前已经被使用,和/或是原本相容的钉仓的假冒形式。如果控制器确定钉仓不是真实的,则控制器无法解密存储在第二RFID标签上的信息,并且/或者存储在第二RFID标签上的信息无法识别。然后RFID扫描器可重新扫描钉仓,或者可扫描新的钉仓32050。如果控制器确定钉仓是真实的,则控制器发布和/或解锁第三内部密钥32070,以用于检测钉仓组件上的保持器的存在。在没有发布和/或解锁第三内部密钥32070的情况下,临床医生无法完成协议32000,并且在各种情况下,无法用不真实的部件激活外科器械,如果不存在如上所述的超控输入的情况下。
钉仓包括定位在保持器上的第三RFID标签,并且该第三RFID标签包括第三组加密信息。第三组加密信息只能由控制器使用第三内部密钥32070来解密。如果加密信息包括表示相容的钉仓的数据,则解密协议32000发布第四内部密钥并且/或者解密协议32000成功结束。如果控制器确定钉仓不是真实的,如果控制器无法解密存储在第三RFID标签上的信息和/或如果存储在第三RFID标签上的信息不能识别,则不发布下一个或第四内部密钥,并且解密协议32000不能继续下一步。RFID扫描器可重新扫描第三RFID标签,或者可扫描新的保持器32080。在没有发布和/或解锁第四内部密钥的情况下,控制器无法完成协议32000,并且在各种情况下,可能无法用不真实的部件激活外科器械。在各种情况下,保持器是在协议32000中评估的最后一个模块化部件。然而,在其他情况下,另外的模块化部件包括具有加密信息的RFID标签,该部件在与外科系统一起使用之前需要认证。
设想本文所述的任何识别系统可用于代替结合协议32000描述的主动和/或被动RFID标签。
本文所述主题的各个方面在以下实施例中阐述:
实施例集1
实施例1.一种用于认证钉仓与外科器械的相容性的方法,所述方法包括将钉仓插入外科器械中。所述方法还包括将来自所述钉仓的第一部件上的第一RFID标签的第一信号发射到RFID读取器系统,并且将来自所述钉仓的第二部件上的第二RFID标签的第二信号发射到所述RFID读取器系统。所述方法还包括将所述第一信号和所述第二信号与用于相容的钉仓的一组已存储数据进行比较,并且如果所述第一信号和所述第二信号匹配用于相容的钉仓的所述一组已存储数据,则将所述外科器械的钉击发系统解锁。
实施例2.根据实施例1所述的方法,其中,所述比较步骤包括将所述第一信号和所述第二信号与用于相容的钉仓的多于一组已存储数据进行比较。
实施例3.根据实施例1或2所述的方法,其中,所述第一RFID标签和所述第二RFID标签包括主动RFID标签。
实施例4.根据实施例1至3所述的方法,还包括在所述从所述第一RFID标签发射第一信号的步骤之前利用所述RFID读取器系统询问所述第一RFID标签的步骤。
实施例5.根据实施例1至4所述的方法,还包括在所述从所述第二RFID标签发射第二信号的步骤之前利用所述RFID读取器系统询问所述第二RFID标签的步骤。
实施例6.根据实施例1至5所述的方法,还包括在所述解锁步骤之后操作所述钉击发系统以执行钉击发行程的步骤。
实施例7.根据实施例1至6所述的方法,其中,所述第一部件包括仓体,并且所述第二部件包括滑动件,在钉击发行程期间所述滑动件能够从近侧未击发位置移动到远侧击发位置。
实施例8.根据实施例7所述的方法,其中,所述将所述第二信号发射到所述RFID读取器系统的步骤仅当所述滑动件处于其近侧未击发位置时才可发生。
实施例9.根据实施例1至8所述的方法,其中,所述第一部件包括仓体,并且所述第二部件包括可移除地附接到所述仓体的盖。
实施例10.根据实施例9所述的方法,其中,所述将所述第二信号发射到所述RFID读取器系统的步骤仅当所述盖附接到所述仓体时才可发生。
实施例11.一种用于认证钉仓与外科器械的相容性的方法,所述方法包括将钉仓插入外科器械中。所述方法还包括利用RFID读取器系统接收来自所述钉仓的第一部件上的第一RFID标签的第一信号,并且利用所述RFID读取器系统接收来自所述钉仓的第二部件上的第二RFID标签的第二信号。所述方法还包括将所述第一信号和所述第二信号与用于相容的钉仓的已存储数据进行比较,并且如果所述第一信号和所述第二信号不匹配用于相容的钉仓的所述已存储数据,则将所述外科器械的钉击发系统锁定。
实施例12.根据实施例11所述的方法,其中,所述比较步骤包括将所述第一信号和所述第二信号与用于多于一个相容的钉仓的已存储数据进行比较。
实施例13.根据实施例11和12所述的方法,其中,所述第一RFID标签和所述第二RFID标签包括主动RFID标签。
实施例14.根据实施例11至13所述的方法,还包括在所述接收来自所述第一RFID标签的第一信号的步骤之前利用所述RFID读取器系统询问所述第一RFID标签的步骤。
实施例15.根据实施例11至14所述的方法,还包括在所述接收来自所述第二RFID标签的第二信号的步骤之前利用所述RFID读取器系统询问所述第二RFID标签的步骤。
实施例16.根据实施例11至15所述的方法,还包括在未发生所述锁定步骤的情况下操作所述钉击发系统以执行钉击发行程的步骤。
实施例17.根据实施例11至16所述的方法,其中,所述第一部件包括仓体,并且所述第二部件包括滑动件,在钉击发行程期间所述滑动件能够从近侧未击发位置移动到远侧击发位置。
实施例18.根据实施例17所述的方法,其中,所述利用所述RFID读取器系统接收所述第二信号的步骤仅当所述滑动件处于其近侧未击发位置时才可发生。
实施例19.根据实施例11至18所述的方法,其中,所述第一部件包括仓体,并且所述第二部件包括可移除地附接到所述仓体的盖。
实施例20.根据实施例19所述的方法,其中,所述利用所述RFID读取器系统接收所述第二信号的步骤仅当所述盖附接到所述仓体时才可发生。
实施例集2
实施例1.一种外科器械,所述外科器械包括被构造成能够执行击发运动的击发系统、端部执行器和RFID读取器系统。所述端部执行器包括砧座、钉仓支撑件和定位在所述钉仓支撑件中的钉仓。所述钉仓包括限定纵向轴线的仓体、限定在所述仓体中的纵向狭槽,和限定在所述仓体中的钉腔。所述钉仓还包括可移除地储存在所述钉腔中的钉、可释放地附接到所述仓体的盖,其中当所述盖附接到所述仓体时,所述盖在所述钉腔上方延伸。所述钉仓还包括在所述击发运动期间能够从近侧未击发位置移动到远侧击发位置的滑动件、在第一纵向位置处附连到所述仓体的第一RFID标签和附连到所述滑动件的第二RFID标签,其中所述滑动件的所述近侧未击发位置处于不同于所述第一纵向位置的第二纵向位置处。所述钉仓还包括第三RFID标签,所述第三RFID标签在不同于所述第一纵向位置和所述第二纵向位置的第三纵向位置处附连到所述盖。所述RFID读取器系统被构造成能够接收来自所述第一纵向位置处的所述第一RFID标签的第一信号、来自所述第二纵向位置处的所述第二RFID标签的第二信号和来自所述第三纵向位置处的所述第三RFID标签的第三信号。
实施例2.根据实施例1所述的缝合器械,其中,所述RFID读取器系统包括第一RFID读取器、第二RFID读取器和第三RFID读取器。
实施例3.根据实施例2所述的缝合器械,其中,所述第一RFID读取器系统包括邻近所述第一纵向位置的第一天线,其中所述第二RFID系统包括邻近所述第二纵向位置的第二天线,并且其中所述第三RFID系统包括邻近所述第三纵向位置的第三天线。
实施例4.根据实施例1至3所述的缝合器械,其中,所述第一RFID标签被配置为在第一范围发射所述第一信号,其中所述第一天线定位在所述第一范围中并且被配置为接收所述第一信号,其中所述第二RFID标签被配置为在第二范围发射所述第二信号,其中所述第二RFID标签被配置为发射第二范围,其中所述第二天线定位在所述第二范围中并且被配置为接收所述第二信号,其中所述第三RFID标签被配置为在第三范围发射所述第三信号,并且其中所述第三天线定位在所述第三范围中并且被配置为接收所述第三信号。
实施例5.根据实施例4所述的缝合器械,其中,所述第一范围不与所述第二范围和所述第三范围重叠,并且其中所述第二范围不与所述第一范围和所述第三范围重叠。
实施例6.根据实施例2至5所述的缝合器械,其中,所述第一RFID读取器系统包括邻近所述第一纵向位置的第一感应线圈传感器,其中所述第二RFID系统包括邻近所述第二纵向位置的第二感应线圈传感器,并且其中所述第三RFID系统包括邻近所述第三纵向位置的第三感应线圈传感器。
实施例7.根据实施例6所述的缝合器械,其中,所述第一RFID标签被配置为在第一范围发射所述第一信号,其中所述第一感应线圈传感器定位在所述第一范围中并且被配置为接收所述第一信号,其中所述第二RFID标签被配置为在第二范围发射所述第二信号,其中所述第二感应线圈传感器定位在所述第二范围中并且被配置为接收所述第二信号,其中所述第三RFID标签被配置为在第三范围发射所述第三信号,并且其中所述第三感应线圈传感器定位在所述第三范围中并且被配置为接收所述第三信号。
实施例8.根据实施例6和7所述的缝合器械,其中,所述第一范围不与所述第二范围和所述第三范围重叠,并且其中所述第二范围不与所述第一范围和所述第三范围重叠。
实施例9.根据实施例1至8所述的缝合器械,其中,所述第一RFID标签包括主动RFID标签,其中所述第二RFID标签包括主动RFID标签,并且其中所述第三RFID标签包括主动RFID标签。
实施例10.根据实施例1至8所述的缝合器械,其中,所述第一RFID标签包括被动RFID标签,其中所述第二RFID标签包括被动RFID标签,并且其中所述第三RFID标签包括被动RFID标签。
实施例11.根据实施例1至10所述的缝合器械,其中,所述钉仓包括侧向宽度,并且其中所述第一纵向位置、所述第二纵向位置和所述第三纵向位置未跨所述侧向宽度侧向地对准。
实施例12.根据实施例1至11所述的缝合器械,其还包括与所述RFID读取器系统和所述击发系统通信的控制器,其中所述控制器被配置为如果所述第一信号、所述第二信号和所述第三信号中的至少一者未被所述RFID系统接收则阻止所述击发系统的操作。
实施例13.根据实施例1至12所述的缝合器械,还包括与所述RFID读取器系统和所述击发系统通信的控制器,其中所述控制器包括存储在存储器装置中的至少一组数据,其中所述控制器被配置为将来自所述第一信号、所述第二信号和所述第三信号的数据与一组数据进行比较,其中所述控制器被配置为如果来自所述第一信号、所述第二信号和所述第三信号中的至少一者的数据与所述一组数据不一致则禁用所述击发系统。
实施例14.一种钉仓组件,所述钉仓组件包括限定纵向轴线的仓体、限定在所述仓体中的纵向狭槽,和限定在所述仓体中的钉腔。所述钉仓组件还包括可移除地储存在所述钉腔中的钉、可释放地附接到所述仓体的盖,其中当所述盖附接到所述仓体时,所述盖在所述钉腔上方延伸。所述钉仓组件还包括在所述击发运动期间能够从近侧未击发位置移动到远侧击发位置的滑动件、在第一纵向位置处附连到所述仓体的第一RFID标签、附连到所述滑动件的第二RFID标签、和在第三纵向位置处附连到所述盖的第三RFID标签,其中所述滑动件的所述近侧未击发位置处于不同于所述第一纵向位置的第二纵向位置,并且所述第三纵向位置不处于所述第一纵向位置和所述第二纵向位置。
实施例15.一种外科器械,所述外科器械包括被构造成能够执行击发运动的击发系统、端部执行器、RFID读取器系统,和控制器。所述端部执行器包括砧座、钉仓支撑件和能够定位在所述钉仓支撑件中的钉仓。所述钉仓包括具有近侧端部和远侧端部的仓体、限定在所述仓体中的纵向狭槽,合限定在所述仓体中的钉腔。所述钉仓还包括可移除地储存在所述钉腔中的钉,和在所述击发运动期间能够从近侧未击发位置移动到远侧击发位置的滑动件。所述钉仓还包括在所述近侧端部处附连到所述仓体的第一RFID标签,和在所述远侧端部处附连到所述仓体的第二RFID标签。所述RFID读取器系统被配置为接收来自所述第一RFID标签的第一信号和来自所述第二RFID标签的第二信号。所述控制器与所述RFID读取器系统和所述击发系统通信,其中所述控制器被配置为如果所述控制器接收到所述第一信号和所述第二信号中的一者而未接收到另一者则禁用所述击发系统的操作。
实施例16.根据实施例15所述的外科器械,还包括与所述控制器通信的反馈系统,其中所述控制器被配置为当所述控制器禁用所述击发系统的操作时激活所述反馈系统。
实施例17.根据实施例15或16所述的外科器械,其中,所述控制器包括存储在存储器装置中的一组数据,其中所述控制器被配置为将来自所述第一信号和所述第二信号的数据与一组数据进行比较,其中所述控制器被配置为如果来自所述第一信号和所述第二信号中的一者的数据与所述一组数据不一致则禁用所述击发系统。
实施例18.一种钉仓,所述钉仓包括仓体,所述仓体包括近侧端部和远侧端部。所述钉仓还包括限定在所述仓体中的纵向狭槽、限定在所述仓体中的钉腔,和可移除地储存在所述钉腔中的钉。所述钉仓还包括在所述击发运动期间能够从近侧未击发位置移动到远侧击发位置的滑动件、在所述近侧端部处附连到所述仓体的所述第一RFID标签,和在所述远侧端部处附连到所述仓体的第二RFID标签。
实施例集3
实施例1.一种外科器械,所述外科器械包括钉击发系统、端部执行器、第一RFID读取器、第二RFID读取器,和控制器。所述端部执行器包括砧座、钉仓通道和定位在所述钉仓通道中的钉仓。所述钉仓包括具有纵向轴线的仓体、限定在所述仓体中的钉腔,和可移除地储存在所述钉腔中的钉。所述钉仓还包括能够由所述钉击发系统在近侧未击发位置和远侧击发位置之间移动的滑动件、附连到所述仓体的第一RFID标签,和附连到所述滑动件的第二RFID标签。所述第一RFID读取器被配置为检测来自所述第一RFID标签的第一信号,并且所述第二RFID读取器被配置为检测来自所述第二RFID标签的第二信号。所述控制器与所述第一RFID读取器、所述第二RFID读取器和所述钉击发系统通信,其中所述控制器在接收到来自所述第一RFID标签的所述第一信号时验证所述钉仓在所述钉仓通道中的存在,并且其中所述控制器在接收到来自所述第二RFID标签的所述第二信号时验证所述钉仓是未击发的钉仓。
实施例2.根据实施例1所述的外科器械,其中,所述控制器被配置为如果所述控制器接收到所述第一信号但未接收到所述第二信号则禁用所述钉击发系统。
实施例3.根据实施例1和2所述的外科器械,其中,所述控制器被配置为当所述控制器接收到所述第一信号和所述第二信号时解锁所述钉击发系统。
实施例4.根据实施例1至3所述的外科器械,其中,所述第一RFID标签包括第一操作范围,并且所述第二RFID标签包括第二操作范围,并且其中当所述滑动件处于所述近侧未击发位置时,所述第一操作范围和所述第二操作范围不重叠。
实施例5.根据实施例1至4所述的外科器械,其中,所述第一RFID读取器包括第一操作范围,并且所述第二RFID读取器包括第二操作范围,并且其中所述第一操作范围和所述第二操作范围不重叠。
实施例6.根据实施例1至5所述的外科器械,还包括与所述控制器通信的第三RFID读取器,并且其中所述第三RFID读取器被配置为当所述滑动件处于所述远侧击发位置时检测来自所述第二RFID标签的所述第二信号。
实施例7.根据实施例6所述的外科器械,其中,当所述滑动件处于所述远侧击发位置时,所述第二RFID读取器无法检测到所述第二信号,并且其中当所述滑动件处于所述近侧未击发位置时,所述第三RFID读取器无法检测到所述第二信号。
实施例8.根据实施例1至7所述的外科器械,其中,所述控制器包括存储在存储器装置中的一组数据,其中所述控制器被配置为将来自所述第一信号和所述第二信号的数据与一组数据进行比较,其中所述控制器被配置为如果来自所述第一信号和所述第二信号中的一者的数据与所述一组数据不一致则禁用所述钉击发系统。
实施例9.根据实施例1至8所述的外科器械,其中,所述钉仓还包括可释放地附接到所述仓体的可移除盖,其中所述可移除盖包括固定到其上的第三RFID标签,其中所述第三RFID标签被配置为发射第三信号,其中所述外科器械还包括第三RFID读取器,所述第三RFID读取器被配置为当所述可移除盖附接到所述仓体时接收所述第三信号,并且其中当所述可移除盖与所述仓体分离时,所述第三RFID读取器无法接收所述第三信号。
实施例10.根据实施例1至9所述的外科器械,其中,所述第一RFID标签包括主动RFID标签,并且其中所述第二RFID标签包括主动RFID标签。
实施例11.根据实施例1至9所述的外科器械,其中,所述第一RFID标签包括被动RFID标签,并且其中所述第二RFID标签包括被动RFID标签。
实施例12.一种外科器械,所述外科器械包括钉击发系统、端部执行器、第一RFID读取器、第二RFID读取器,和控制器。所述端部执行器包括砧座、钉仓支撑件和定位在所述钉仓支撑件中的钉仓。所述钉仓包括具有纵向轴线的仓体、限定在所述仓体中的钉腔,和可移除地储存在所述钉腔中的钉。所述钉仓还包括能够由所述钉击发系统在近侧未击发位置和远侧击发位置之间移动的滑动件、安装到所述仓体的第一RFID标签,和安装到所述滑动件的第二RFID标签。所述第一RFID读取器被配置为接收来自所述第一RFID标签的第一信号。所述第二RFID读取器被配置为接收来自所述第二RFID标签的第二信号。所述控制器与所述第一RFID读取器、所述第二RFID读取器和所述钉击发系统通信,其中所述控制器在接收到来自所述第一RFID标签的所述第一信号时验证所述钉仓在所述钉仓通道中的存在,并且其中所述控制器在接收到来自所述第二RFID标签的所述第二信号时验证所述钉仓是未击发的钉仓。
实施例13.一种外科器械,所述外科器械包括钉击发系统、端部执行器、第一RFID读取器、第二RFID读取器,和控制器。所述端部执行器包括砧座、钉仓通道和定位在所述钉仓通道中的钉仓。所述钉仓包括具有纵向轴线的仓体、限定在所述仓体中的钉腔,和可移除地储存在所述钉腔中的钉。所述钉仓还包括可释放地附接到所述仓体的可移除盖、能够由所述钉击发系统在近侧未击发位置和远侧击发位置之间移动的滑动件、附连到所述仓体的第一RFID标签,和附连到所述可移除盖的第二RFID标签。所述第一RFID读取器被配置为检测来自所述第一RFID标签的第一信号。所述第二RFID读取器被配置为检测来自所述第二RFID标签的第二信号。所述控制器与所述第一RFID读取器、所述第二RFID读取器和所述钉击发系统通信,其中所述控制器在接收到来自所述第一RFID标签的所述第一信号时验证所述钉仓在所述钉仓通道中的存在,并且其中所述控制器在接收到来自所述第二RFID标签的所述第二信号时验证所述钉仓是未遭破坏的钉仓。
实施例14.根据实施例13所述的外科器械,其中,所述控制器被配置为如果所述控制器接收到所述第一信号但未接收到所述第二信号则禁用所述钉击发系统。
实施例15.根据实施例13和14所述的外科器械,其中,所述控制器被配置为当所述控制器接收到所述第一信号和所述第二信号时解锁所述钉击发系统。
实施例16.根据实施例13至15所述的外科器械,其中,所述第一RFID标签包括第一操作范围,并且所述第二RFID标签包括第二操作范围,并且其中当所述盖附接到所述仓体时,所述第一操作范围和所述第二操作范围不重叠。
实施例17.根据实施例13至16所述的外科器械,其中,所述第一RFID读取器包括第一操作范围,并且所述第二RFID读取器包括第二操作范围,并且其中所述第一操作范围和所述第二操作范围不重叠。
实施例18.根据实施例13至17所述的外科器械,其中,所述控制器包括存储在存储器装置中的一组数据,其中所述控制器被配置为将来自所述第一信号和所述第二信号的数据与一组数据进行比较,其中所述控制器被配置为如果来自所述第一信号和所述第二信号中的一者的数据与所述一组数据不一致则禁用所述钉击发系统。
实施例集4
实施例1.一种外科器械,所述外科器械包括端部执行器和RFID读取器。所述端部执行器包括近侧端部、远侧端部,和在所述近侧端部和所述远侧端部之间延伸的纵向轴线。所述端部执行器还包括砧座、钉仓通道和定位在所述钉仓通道中的钉仓。所述钉仓包括具有纵向狭槽的仓体、可释放地附接到所述仓体的可移除盖,和限定在所述仓体中的钉腔。所述钉仓还包括可移除地储存在所述钉腔中的钉、在钉击发行程期间能够相对于所述纵向狭槽移动的滑动件,和在标签平面中安装到所述钉仓的RFID标签。所述RFID读取器包括感应线圈接收器,其中所述感应线圈接收器在接收器平面中安装到所述钉仓通道的侧壁,其中所述接收器平面基本上平行于所述标签平面,并且其中所述接收器平面基本上平行于所述纵向轴线。
实施例2.根据实施例1所述的外科器械,其中,所述RFID标签安装到所述仓体。
实施例3.根据实施例1和2所述的外科器械,其中,所述仓体包括第一侧壁、第二侧壁,和在所述第一侧壁与所述第二侧壁之间延伸的平台,其中所述钉腔限定在所述平台中,并且其中所述RFID标签安装到所述第一侧壁。
实施例4.根据实施例3所述的外科器械,其中,所述RFID标签安装到所述第一侧壁的外表面。
实施例5.根据实施例3所述的外科器械,其中,所述RFID标签安装到所述第一侧壁的内表面。
实施例6.根据实施例3所述的外科器械,其中,所述RFID标签嵌入在所述第一侧壁中。
实施例7.根据实施例6所述的外科器械,其中,所述RFID标签一体成型到所述第一侧壁中。
实施例8.根据实施例3所述的外科器械,其中,所述第一侧壁包括限定在其中的凹陷部,并且其中所述RFID标签被安置在所述凹陷部中。
实施例9.根据实施例8所述的外科器械,其中,所述凹陷部限定凹陷部周边,并且其中所述RFID标签包括与所述凹陷部周边匹配的标签周边。
实施例10.根据实施例1所述的外科器械,其中,所述RFID标签安装到所述滑动件。
实施例11.根据实施例10所述的外科器械,其中,所述滑动件包括定位在所述纵向狭槽中的纵向部分,并且其中所述RFID标签附连到所述纵向部分。
实施例12.根据实施例11所述的外科器械,其中,所述RFID标签一体成型到所述纵向部分中。
实施例13.根据实施例10所述的外科器械,其中,所述纵向部分包括限定在其中的凹陷部,并且其中所述RFID标签被安置在所述凹陷部中。
实施例14.根据实施例13所述的外科器械,其中,所述凹陷部限定凹陷部周边,并且其中所述RFID标签包括与所述凹陷部周边匹配的标签周边。
实施例15.根据实施例10所述的外科器械,其中,所述侧壁包括在第一侧向侧壁和第二侧向侧壁之间延伸的底部侧壁。
实施例16.根据实施例10所述的外科器械,其中,所述侧壁包括从底部侧壁延伸的侧向侧壁。
实施例17.根据实施例10所述的外科器械,还包括能够移动地定位在所述钉腔内的钉驱动器,其中所述滑动件包括轨道,所述轨道被构造成能够在所述钉击发行程期间接合所述钉驱动器以从所述钉腔射出所述钉,其中所述RFID标签安装到所述轨道中的一条轨道。
实施例18.根据实施例1所述的外科器械,其中,所述RFID标签附连到所述可移除盖。
实施例19.根据实施例18所述的外科器械,其中,所述可移除盖在所述钉腔上方延伸,其中所述可移除盖包括与所述仓体可释放地接合的闩锁和定位在所述纵向槽内的纵向翅片,并且其中所述RFID标签安装到所述纵向翅片。
实施例20.根据实施例19所述的外科器械,其中,所述RFID标签一体成型到所述纵向翅片中。
实施例21.根据实施例18所述的外科器械,其中,所述纵向翅片包括限定在其中的凹陷部,并且其中所述RFID标签被安置在所述凹陷部中。
实施例22.根据实施例21所述的外科器械,其中,所述凹陷部限定凹陷部周边,并且其中所述RFID标签包括与所述凹陷部周边匹配的标签周边。
实施例23.根据实施例1至22所述的外科器械,其中,所述RFID标签包括基部、安装到所述基部的微芯片,和安装到所述基部的芯片天线,其中所述芯片天线基本上平行于所述感应线圈接收器的接收器天线。
实施例24.根据实施例1至23所述的外科器械,其中,所述芯片天线周向围绕芯片天线轴线,其中所述接收器天线周向围绕接收器天线轴线,并且其中所述芯片天线轴线和所述接收器天线轴共线。
实施例25.根据实施例1至23所述的外科器械,其中,所述芯片天线周向围绕芯片天线轴线,其中所述接收器天线周向围绕接收器天线轴线,并且其中所述芯片天线轴线和所述接收器天线轴线正交于所述纵向轴线。
实施例26.一种外科器械,所述外科器械包括端部执行器和RFID读取器。所述端部执行器包括钉仓支撑件和定位在所述钉仓支撑件中的钉仓。所述钉仓包括具有纵向轴线的仓体、限定在所述仓体中的钉腔,和可移除地储存在所述钉腔中的钉。所述钉仓还包括安装到所述钉仓的RFID标签,其中所述RFID标签包括基部和安装到所述基部的标签天线,并且其中所述标签天线限定在标签平面中。所述RFID读取器包括感应线圈接收器,其中所述感应线圈接收器在接收器平面中安装到所述钉仓支撑件,其中所述接收器平面基本上平行于所述标签平面。
实施例27.一种外科器械的端部执行器,所述端部执行器包括钉仓支撑件、钉仓,和RFID读取器。所述钉仓定位在所述钉仓支撑件中并且包括具有纵向狭槽的仓体和限定在所述仓体中的钉腔。所述钉仓还包括可移除地储存在所述钉腔中的钉和安装到所述钉仓的RFID标签,其中所述RFID标签包括限定在标签平面中的标签天线。所述RFID读取器包括接收器天线,其中所述接收器天线在接收器平面中安装到所述钉仓支撑件,其中所述接收器平面平行于所述标签平面。
实施例集5
实施例1.一种外科系统,所述外科系统包括外科器械、可替换钉仓、保持器、RFID扫描器、控制器。所述外科器械包括细长轴和从所述细长轴延伸的端部执行器,其中所述端部执行器包括第一钳口和第二钳口。所述可替换钉仓被构造成能够安置在所述第一钳口中,其中所述可替换钉仓在被安置在所述第一钳口中之前储存在包装中,其中所述包装包括第一RFID标签,其中所述第一RFID标签包括第一组加密信息,并且其中所述可替换钉仓包括具有仓平台的仓体、可移除地储存在所述仓体中的钉、被构造成能够在钉击发行程期间将所述钉驱动到所述仓体之外的滑动件,和包括第二组加密信息的第二RFID标签。所述保持器可释放地附接到所述可替换钉仓,其中所述保持器在所述仓平台上延伸,并且其中所述保持器包括第三RFID标签,所述第三RFID标签包括第三组加密信息。所述RFID扫描器被配置为接收所述第一组加密信息、所述第二组加密信息和所述第三组加密信息。所述控制器被配置为执行解密协议,其中所述控制器包括第一内部密钥,其中所述控制器使用所述第一内部密钥来解密所述第一组加密信息,其中如果所述第一组加密信息被所述控制器识别,则所述控制器发布第二内部密钥,其中所述控制器使用所述第二组加密信息来解密所述第二组加密信息,其中如果所述第二组加密信息被所述控制器识别,则所述控制器发布第三内部密钥,其中所述控制器使用所述第三内部密钥来解密所述第三组加密信息,并且其中如果所述第一组加密信息、所述第二组加密信息和所述第三组加密信息中的至少一者无法被识别,则所述控制器阻止所述外科器械执行所述钉击发行程。
实施例2.根据实施例1所述的外科系统,其中,如果所述控制器无法解密所述第一组加密信息、所述第二组加密信息和所述第三组加密信息中的至少一者,则所述控制器阻止所述外科器械执行所述钉击发行程。
实施例3.根据实施例1或2所述的外科系统,其中,所述RFID扫描器被配置为接收响应于第一询问信号的所述第一组加密信息。
实施例4.根据实施例3所述的外科系统,其中,如果所述RFID扫描器未接收到响应于所述第一询问信号的所述第一组加密信息,则所述控制器阻止所述外科器械执行所述钉击发行程。
实施例5.根据实施例3或4所述的外科系统,其中,所述RFID扫描器被配置为接收响应于第二询问信号的所述第二组加密信息。
实施例6.根据实施例5所述的外科系统,其中,如果所述控制器无法识别所述第一组加密信息,则所述RFID扫描器不发射所述第二询问信号。
实施例7.根据实施例5或6所述的外科系统,其中,所述RFID扫描器被配置为接收响应于第三询问信号的所述第三组加密信息。
实施例8.根据实施例7所述的外科系统,其中,如果所述控制器无法识别所述第二组加密信息,则所述RFID扫描器不发射所述第三询问信号。
实施例9.根据实施例1至8中任一项所述的外科系统,其中,所述RFID扫描器包括读取能力和写入能力。
实施例10.一种外科系统,所述外科系统包括外科器械、可替换钉仓、可释放地附接到所述可替换钉仓的保持器、包括第一组加密信息的第一RFID标签、包括第二组加密信息的第二RFID标签、被配置为接收所述第一组加密信息和所述第二组加密信息的RFID扫描器,和包括第一内部密钥的控制器。所述外科器械包括细长轴和从所述细长轴延伸的端部执行器,其中所述端部执行器包括第一钳口和第二钳口。所述可替换钉仓被构造成能够安置在所述第一钳口中,其中所述可替换钉仓包括具有仓平台的仓体、可移除地储存在所述仓体中的钉,和被构造成能够在钉击发行程期间将所述钉驱动到所述仓体之外的滑动件。所述保持器在所述仓平台上方延伸。所述控制器使用所述第一内部密钥来解密第一组加密信息,其中如果所述第一组加密信息被所述控制器识别,则所述控制器发布第二内部密钥,其中所述控制器使用所述第二内部密钥来解密所述第二组加密信息,并且其中如果所述第一组加密信息和所述第二组加密信息中的至少一者无法被识别,则所述控制器阻止所述外科器械执行操作功能。
实施例11.根据实施例10所述的外科系统,其中,所述操作功能包括钉击发行程。
实施例12.根据实施例10或11所述的外科系统,其中,所述控制器包括存储器,其中一组相容信息存储在所述存储器中,其中如果所述第一组加密信息和所述第二组加密信息中的至少一者不对应于所述一组相容信息,则所述控制器阻止所述外科器械执行所述操作功能。
实施例13.根据实施例10至12中任一项所述的外科系统,其中,所述第一RFID标签定位在所述可替换钉仓上。
实施例14.根据实施例10至13中任一项所述的外科系统,其中,所述第二RFID标签定位在所述保持器上。
实施例15.根据实施例10至14中任一项所述的外科系统,其中,所述RFID扫描器被配置为接收响应于第一询问信号的所述第一组加密信息。
实施例16.根据实施例15所述的外科系统,其中,如果所述RFID扫描器未接收到响应于所述第一询问信号的所述第一组加密信息,则所述控制器阻止所述外科器械执行所述钉击发行程。
实施例17.根据实施例15或16所述的外科系统,其中,所述RFID扫描器被配置为接收响应于第二询问信号的所述第二组加密信息。
实施例18.根据实施例17所述的外科系统,其中,如果所述控制器无法识别所述第一组加密信息,则所述RFID扫描器不发射所述第二询问信号。
实施例19.根据实施例10至18中任一项所述的外科系统,还包括第三RFID标签,其中所述可替换钉仓在被安置在所述第一钳口中之前储存在包装内,并且其中所述第三RFID标签定位在所述包装上。
实施例20.一种外科系统,所述外科系统包括外科器械、可替换钉仓、可释放地附接到所述可替换钉仓的保持器、RFID扫描器,和包括第一内部密钥的控制器。所述外科器械包括细长轴和从所述细长轴延伸的端部执行器,其中所述端部执行器包括第一钳口和第二钳口。所述可替换钉仓被构造成能够安置在所述第一钳口中,其中所述可替换钉仓在被安置在所述第一钳口中之前储存在包装中,其中所述包装包括第一RFID标签,其中所述第一RFID标签包括第一组加密信息,并且其中所述可替换钉仓包括具有仓平台的仓体、可移除地储存在所述仓体中的钉、被构造成能够在钉击发行程期间将所述钉驱动到所述仓体之外的滑动件,和包括第二组加密信息的第二RFID标签。所述保持器在所述仓平台上方延伸并且包括第三RFID标签,所述第三RFID标签包括第三组加密信息。所述RFID扫描器被配置为接收所述第一组加密信息、所述第二组加密信息和所述第三组加密信息。所述控制器使用所述第一内部密钥来解密所述第一组加密信息,其中如果所述控制器确定所述第一组加密信息相容以用于与所述外科系统一起使用,则所述控制器发布第二内部密钥,其中所述控制器使用所述第二内部密钥来解密所述第二组加密信息,其中如果所述控制器确定所述第二组加密信息相容以用于与所述外科系统一起使用,则所述控制器发布第三内部密钥,其中所述控制器使用所述第三内部密钥来解密所述第三组加密信息,并且其中如果所述第一组加密信息、所述第二组加密信息和所述第三组加密信息中的至少一者不相容从而不能与所述外科系统一起使用,则所述外科器械不可操作。
实施例集6
实施例1.一种外科系统,所述外科系统包括外科器械、RFID扫描器、控制器,和远程存储系统。所述外科器械包括端部执行器、可替换钉仓,和保持器。所述端部执行器包括第一钳口和第二钳口。所述可替换钉仓被构造成能够安置在所述第一钳口中,其中所述可替换钉仓包括具有仓平台的仓体、可移除地定位在所述仓体中的钉、包括第一组信息的第一RFID标签,和包括第二RFID标签的滑动件,所述第二RFID标签包括第二组信息,其中所述滑动件被构造成能够在钉击发行程期间将所述钉驱动到所述仓体之外。所述保持器可移除地附接到所述可替换钉仓,其中所述保持器定位成邻近所述仓平台,其中所述保持器包括第三RFID标签,所述第三RFID标签包括第三组信息,其中所述第一组信息、所述第二组信息和所述第三组信息共同形成独特组合,并且其中所述独特组合表示所述可替换钉仓。所述RFID扫描器被配置为接收所述第一组信息、所述第二组信息和所述第三组信息。所述控制器与所述RFID扫描器通信。所述远程存储系统包括一组相容组合,其中所述控制器将所述独特组合与所述一组相容组合进行比较以确定所述可替换钉仓是否相容以用于与所述外科器械一起使用,并且其中如果所述控制器确定所述独特组合不相容从而不能与所述外科器械一起使用,则所述控制器阻止所述外科器械的至少一个操作。
实施例2.根据实施例1所述的外科系统,其中,所述一组相容组合包括与可替换钉仓相关联的独特组合的列表。
实施例3.根据实施例1或2所述的外科系统,其中,所述一组相容组合包括召回信息,其中如果所述可替换钉仓和所述保持器中的至少一者被召回,则所述控制器阻止所述外科器械的所述至少一个操作。
实施例4.根据实施例1至3中任一项所述的外科系统,其中,所述外科系统的所述至少一个操作包括所述钉击发行程。
实施例5.根据实施例1至4中任一项所述的外科系统,其中,所述可替换钉仓在被安置在所述第一钳口中之前储存在包装中,并且其中所述独特组合以加密形式显示在所述包装上。
实施例6.根据实施例5所述的外科系统,其中,所述远程存储系统包括解密协议,所述解密协议被配置为解密所述独特组合的所述加密形式。
实施例7.根据实施例5或6所述的外科系统,其中,所述独特组合的所述加密形式被印刷在所述包装上。
实施例8.根据实施例1至7中任一项所述的外科系统,其中,所述第一RFID标签、所述第二RFID标签和所述第三RFID标签包括加密信息。
实施例9.根据实施例8所述的外科系统,其中,所述远程存储系统包括解密协议,所述解密协议被配置为解密包括在所述第一RFID标签、所述第二RFID标签和所述第三RFID标签上的所述加密信息。
实施例10.根据实施例1至9中任一项所述的外科系统,其中,所述RFID扫描器被配置为接收响应于第一询问信号的所述第一组信息。
实施例11.根据实施例1至10中任一项所述的外科系统,其中,所述控制器定位在所述外科器械上。
实施例12.根据实施例1至10中任一项所述的外科系统,其中,所述控制器相对于所述外科器械远程定位。
实施例13.一种外科系统,所述外科系统包括外科器械、可替换钉仓、保持器、第一RFID标签、第二RFID标签、第三RFID标签、RFID扫描器、控制器,和远程存储系统。所述可替换钉仓包括具有仓平台的仓体、可移除地定位在所述仓体中的钉,和被构造成能够在钉击发行程期间将所述钉驱动到所述仓体之外的滑动件。所述保持器可移除地附接到所述可替换钉仓,其中所述保持器定位成邻近所述仓平台。所述第一RFID标签包括第一组信息,所述第二RFID标签包括第二组信息,并且所述第三RFID标签包括第三组信息,其中所述第一组信息、所述第二组信息和所述第三组信息共同形成独特组合。所述RFID扫描器被配置为接收所述第一组信息、所述第二组信息和所述第三组信息。所述控制器与所述RFID扫描器通信。所述远程存储系统包括一组相容组合,其中所述控制器将所述独特组合与所述一组相容组合进行比较以确定所述可替换钉仓是否相容以用于与所述外科系统一起使用,并且其中如果所述控制器确定所述可替换的钉不相容从而不能与所述外科系统一起使用,则所述控制器阻止所述外科系统的至少一个操作。
实施例14.根据实施例13所述的外科系统,其中,所述一组相容组合包括与各个可替换钉仓相关联的独特组合的列表。
实施例15.根据实施例13或14所述的外科系统,其中,所述一组相容组合包括召回信息,其中如果所述可替换钉仓被召回,则所述控制器阻止所述外科器械的所述至少一个操作。
实施例16.根据实施例13至15中任一项所述的外科系统,其中,所述外科系统的所述至少一个操作包括所述钉击发行程。
实施例17.根据实施例13至16中任一项所述的外科系统,其中,所述可替换钉仓在被安置在所述外科器械的所述第一钳口中之前储存在包装中,并且其中所述独特组合以加密形式显示在所述包装上。
实施例18.根据实施例13至17中任一项所述的外科系统,其中,所述第一RFID标签、所述第二RFID标签和所述第三RFID标签包括加密信息。
实施例19.根据实施例18所述的外科系统,其中,所述远程存储系统包括解密协议,所述解密协议被配置为解密包括在所述第一RFID标签、所述第二RFID标签和所述第三RFID标签上的所述加密信息。
实施例20.一种外科系统,所述外科系统包括外科器械、可替换钉仓、RFID扫描器、控制器,和远程存储系统。所述可替换钉仓包括具有仓平台的仓体、可移除地定位在所述仓体中的钉、包括第一组加密信息的第一RFID标签,和包括第二RFID标签的滑动件,所述第二RFID标签包括第二组加密信息,其中所述滑动件被构造成能够在钉击发行程期间将所述钉驱动到所述仓体之外,其中所述第一组加密信息和所述第二组加密信息共同形成独特组合,并且其中所述独特组合表示所述可替换钉仓。所述RFID扫描器被配置为接收所述第一组加密信息和所述第二组加密信息。所述控制器与所述RFID扫描器通信。所述远程存储系统包括解密协议和一组相容组合,其中所述远程存储系统解密所述独特组合并且将所解密的独特组合与所述一组相容组合进行比较以确定所述可替换钉仓是否相容以用于与所述外科器械一起使用,并且其中如果所述控制器确定所述可替换钉仓不相容从而不能与所述外科器械一起使用,则所述控制器阻止所述外科器械的至少一个操作。
实施例集7
实施例1.一种外科缝合器械,所述外科缝合器械包括细长轴、端部执行器、可替换钉仓、RFID扫描器、控制器、闭锁构件,和螺线管。所述端部执行器包括第一钳口和第二钳口。所述可替换钉仓被构造成能够安置在所述第一钳口中,其中所述可替换钉仓包括具有仓平台的仓体、可移除地储存在所述仓体中的钉,和被构造成能够在钉击发行程期间将所述钉驱动到所述仓体之外的滑动件,其中所述滑动件包括近侧部分和包括已存储信息的RFID标签。所述RFID扫描器被配置为在所述可替换钉仓被安置在所述第一钳口中时与所述RFID标签通信。所述闭锁构件包括近侧端部和远侧端部,其中在所述可替换钉仓被安置在所述第一钳口中时,所述闭锁构件的所述远侧端部接触所述滑动件的所述近侧部分。所述螺线管能够被构造成处于激活构型和未激活构型,其中所述螺线管包括外壳、螺栓、弹性构件和感应线圈,其中在所述控制器确定所述可替换钉仓相容以用于与所述外科缝合器械一起使用时,所述控制器将所述螺线管置于所述激活构型,其中在所述螺线管处于所述激活构型时,所述螺栓和所述弹性构件完全定位在所述外壳内,其中在所述RFID扫描器从所述RFID标签接收到指示所述可替换钉仓不相容从而不能与所述外科缝合器械一起使用的信号时,所述控制器将所述螺线管置于所述未激活构型,其中在所述螺线管处于所述未激活构型时,所述螺栓的一部分延伸到所述外壳之外,其中在所述螺线管处于所述未激活构型时,所述螺栓的所述部分阻止所述闭锁构件的近侧移动,并且其中在所述可替换钉仓被安置在所述第一钳口中并且所述螺线管处于所述未激活构型时,所述闭锁构件将所述滑动件向远侧推动。
实施例2.根据实施例1所述的外科缝合器械,其中,当所述控制器确定所述可替换钉仓与所述外科缝合器械不相容时,所述外科缝合器械无法执行所述缝合击发行程。
实施例3.根据实施例1或2所述的外科缝合器械,其中,由所述闭锁构件引起的所述滑动件的远侧移动阻止所述外科缝合器械执行所述钉击发行程。
实施例4.根据实施例1至3中任一项所述的外科缝合器械,还包括击发构件,所述击发构件被构造成能够在所述钉击发行程期间将所述滑动件沿着击发路径平移。
实施例5.根据实施例4所述的外科缝合器械,其中,所述闭锁构件的所述近侧端部包括侧向突出部,其中所述侧向突出部的一部分接合所述击发构件。
实施例6.根据实施例1至5中任一项所述的外科缝合器械,其中,通道限定在所述仓体内,并且其中所述闭锁构件的所述远侧端部的尺寸被设定成接收在所述通道中的一个通道内。
实施例7.根据实施例1至6中任一项所述的外科缝合器械,其中,所述螺线管处于所述未激活构型,直到所述控制器检测到相容的钉仓为止。
实施例8.根据实施例1至7中任一项所述的外科缝合器械,其中,当所述可替换钉仓未被安置在所述第一钳口中时,所述螺线管处于所述未激活构型。
实施例9.根据实施例1至8中任一项所述的外科缝合器械,还包括电动马达和电源,其中当所述螺线管处于所述未激活构型时,所述电源被阻止向所述电动马达供应电力。
实施例10.一种外科器械,所述外科器械包括细长轴、端部执行器、可替换钉仓、RFID扫描器、控制器、闭锁构件,和阻挡螺栓系统。所述端部执行器包括第一钳口和第二钳口。所述可替换钉仓被构造成能够安置在所述第一钳口中,其中所述可替换钉仓包括具有仓平台的仓体、可移除地储存在所述仓体中的钉,和被构造成能够在钉击发行程期间将所述钉驱动到所述仓体之外的滑动件,其中所述滑动件包括近侧部分和包括已存储信息的RFID标签。所述RFID扫描器被配置为在所述可替换钉仓被安置在所述第一钳口中时与所述RFID标签通信。所述闭锁构件包括近侧端部和远侧端部,其中在所述可替换钉仓被安置在所述第一钳口中时,所述闭锁构件的所述远侧端部接触所述滑动件的所述近侧部分,其中所述闭锁构件被构造成能够在所述控制器确定所述可替换钉仓相容以用于与所述外科器械一起使用时沿着路径向近侧平移。所述阻挡螺栓系统包括外壳、螺栓、弹性构件和感应线圈,其中在所述控制器确定所述可替换钉仓相容以用于与所述外科器械一起使用时,所述控制器将所述阻挡螺栓系统置于激活构型,其中在所述阻挡螺栓系统处于所述激活构型时,所述螺栓定位在所述闭锁构件的所述路径的外部,其中在所述控制器确定所述可替换钉仓不相容从而不能与所述外科器械一起使用时,所述控制器将所述阻挡螺栓系统置于未激活构型,其中在所述阻挡螺栓系统处于所述未激活构型时,所述螺栓定位在所述闭锁构件的所述路径内,其中在所述阻挡螺栓系统处于所述未激活构型时,所述螺栓阻止所述闭锁构件的所述近侧平移,并且其中在所述可替换钉仓被安置在所述第一钳口中并且所述阻挡螺栓系统处于所述未激活构型时,所述闭锁构件将所述滑动件向远侧推动。
实施例11.根据实施例10所述的外科器械,其中,当所述RFID扫描器未能从所述RFID标签接收到信号时,所述控制器确定所述可替换钉仓不相容从而不能与所述外科器械一起使用。
实施例12.根据实施例10所述的外科器械,其中,当所述RFID扫描器从所述RFID标签接收到包括表示不相容的钉仓的数据的信号时,所述控制器确定所述可替换钉仓不相容从而不能与所述外科器械一起使用。
实施例13.根据实施例12所述的外科器械,其中,所述不相容的钉仓包括用过的钉仓。
实施例14.根据实施例10至13中任一项所述的外科器械,其中,当所述控制器确定所述可替换钉仓与所述缝合器械不相容时,所述外科器械无法执行所述缝合击发行程。
实施例15.根据实施例10至14中任一项所述的外科器械,其中,由所述闭锁构件引起的所述滑动件的远侧移动阻止所述外科器械执行所述钉击发行程。
实施例16.根据实施例10至15中任一项所述的外科器械,还包括击发构件,所述击发构件被构造成能够在所述钉击发行程期间将所述滑动件沿着击发路径平移,其中所述闭锁构件的所述近侧端部包括侧向突出部,并且其中所述侧向突出部的一部分接合所述击发构件。
实施例17.根据实施例10至16中任一项所述的外科器械,其中,通道限定在所述仓体内,并且其中所述闭锁构件的所述远侧端部的尺寸被设定成接收在所述通道中的一个通道内。
实施例18.根据实施例10或12至17中任一项所述的外科器械,其中,所述RFID扫描器向所述RFID标签发射询问信号,并且其中当所述RFID扫描器未能接收到所述询问信号的响应信号时,所述阻挡螺栓系统处于所述未激活构型。
实施例19.根据实施例10至18中任一项所述的外科器械,还包括电动马达和电源,其中当所述阻挡螺栓系统处于所述未激活构型时,所述电源被阻止向所述电动马达供应电力。
实施例20.一种用于与外科器械一起使用的可替换钉仓,其中,所述可替换钉仓包括具有仓平台的仓体、可移除地定位在所述仓体内的钉、被构造成能够在钉击发行程期间将所述钉驱动到所述仓体之外的滑动件,和包括已存储信息的RFID标签,其中所述RFID标签在所述可替换钉仓附接到所述外科器械时与所述外科器械的RFID扫描器通信,其中当所述外科器械的控制器确定所述可替换钉仓不相容从而不能与所述外科器械一起使用时,所述滑动件在所述可替换钉仓内向远侧推进,并且其中当所确定的不相容的钉仓附接到所述外科器械时,所述控制器阻止所述外科器械执行所述钉击发行程。
实施例集8
实施例1.一种外科系统,所述外科系统包括外科器械,所述外科器械包括端部执行器、可替换钉仓、RFID标签、RFID扫描器,和控制器。所述端部执行器包括第一钳口和第二钳口。所述可替换钉仓被构造成能够安置在所述第一钳口中,其中所述可替换钉仓包括近侧端部、远侧端部、包括仓平台的仓体、从所述近侧端部朝向所述远侧端部延伸的细长狭槽、可移除地储存在所述仓体中的钉,和被构造成能够沿着所述细长狭槽平移并且在钉击发行程期间将所述钉驱动到所述仓体之外的滑动件。所述RFID标签包括已存储信息,其中所述RFID标签在所述外科器械的预定动作之后不可操作。所述RFID扫描器被配置为向RFID标签发射第一信号,其中所述RFID扫描器被配置为从所述RFID标签接收响应于所述第一信号的第二信号。当所述RFID扫描器未从所述RFID标签接收到响应于所述第一信号的所述第二信号时,所述控制器阻止所述外科器械的至少一个操作。
实施例2.根据实施例1所述的外科系统,其中,所述外科器械的所述至少一个操作包括所述钉击发行程。
实施例3.根据实施例1或2所述的外科系统,其中,所述外科器械的所述预定动作包括所述钉击发行程的开始。
实施例4.根据实施例1或2所述的外科系统,其中,所述外科器械的所述预定动作包括所述滑动件的远侧移动。
实施例5.根据实施例1至4中任一项所述的外科系统,其中,当所述控制器确定所述第二信号的所述已存储信息对应于不相容的可替换钉仓时,所述控制器阻止所述外科器械的所述至少一个操作。
实施例6.根据实施例1至5中任一项所述的外科系统,其中,所述RFID标签包括横穿所述细长狭槽的部分,其中所述滑动件在所述钉击发行程期间横切所述部分,并且其中在所述部分被横切之后所述RFID标签无法与所述RFID扫描器通信。
实施例7.根据实施例1至6中任一项所述的外科系统,其中,所述RFID扫描器被配置为向所述RFID标签发射第三信号,其中超过所述RFID标签的阈值功率水平的功率水平发射所述第三信号,并且其中所述第三信号使所述RFID标签不可操作。
实施例8.根据实施例7所述的外科系统,其中,所述RFID标签的至少一部分响应于所述第三信号而熔化。
实施例9.根据实施例1至8中任一项所述的外科系统,还包括可释放地附接到所述可替换钉仓的保持器,其中所述保持器沿着所述仓平台延伸,其中所述RFID标签定位在所述保持器上,并且其中在所述保持器从所述可替换钉仓移除时使所述RFID标签不可操作。
实施例10.根据实施例9所述的外科系统,其中,当从所述可替换钉仓移除所述保持器时,所述RFID标签被物理地破坏。
实施例11.一种用于与外科器械一起使用的可替换钉仓,其中所述可替换钉仓包括近侧端部、远侧端部、包括仓平台的仓体、从所述近侧端部朝向所述远侧端部延伸的细长狭槽、可移除地储存在所述仓体中的钉、被构造成能够沿着所述细长狭槽平移并且在钉击发行程期间将所述钉驱动到所述仓体之外的滑动件、包括与所述可替换钉仓相关的已存储信息的RFID标签,和与所述外科器械的控制器通信的RFID扫描器,其中所述RFID标签在所述外科器械的预定动作之后不可操作,其中所述RFID扫描器向所述RFID标签发射第一信号,其中所述RFID扫描器被配置为从所述RFID标签接收响应于所述第一信号的第二信号,其中当所述RFID标签不可操作时,所述控制器阻止所述外科器械的至少一个操作。
实施例12.根据实施例11所述的可替换钉仓,其中,所述RFID标签包括具有第一通信范围的第一天线,其中所述RFID扫描器定位在所述第一通信范围之外。
实施例13.根据实施例12所述的可替换钉仓,还包括具有第二通信范围的第二天线,其中所述第二天线与所述RFID标签通信,并且其中所述RFID扫描器定位在所述第二通信范围内。
实施例14.根据实施例13所述的可替换钉仓,其中,所述第二天线的一部分横穿所述细长狭槽的近侧部分,其中当所述滑动件向远侧平移通过所述细长狭槽时,所述滑动件破坏所述第二天线的所述部分,并且其中在所述第二天线的所述部分被破坏之后,所述RFID标签无法与所述RFID扫描器通信。
实施例15.根据实施例11至14中任一项所述的可替换钉仓,还包括保持器,其中所述保持器可替换地附接到所述仓体,其中所述保持器沿着所述仓平台延伸,并且其中在所述保持器从所述可替换钉仓移除时,使所述RFID标签不可操作。
实施例16.根据实施例11至15中任一项所述的可替换钉仓,其中,所述外科器械的所述至少一个操作包括所述钉击发行程。
实施例17.根据实施例11至16中任一项所述的可替换钉仓,其中,所述外科器械的所述预定动作包括所述钉击发行程的开始。
实施例18.根据实施例11至16中任一项所述的可替换钉仓,其中,所述外科器械的所述预定动作包括所述滑动件的远侧移动。
实施例19.根据实施例11至18中任一项所述的可替换钉仓,其中,在所述外科器械的所述控制器确定所述第二信号的所述已存储信息对应于不相容的可替换钉仓时,所述控制器阻止所述外科器械的所述至少一个操作。
实施例20.一种外科系统,所述外科系统包括外科器械、可替换钉仓、RFID标签、RFID扫描器,和控制器。所述外科器械包括端部执行器,其中所述端部执行器包括第一钳口和第二钳口。所述可替换钉仓被构造成能够安置在所述第一钳口中,其中所述可替换钉仓包括近侧端部、远侧端部、包括仓平台的仓体、从所述近侧端部朝向所述远侧端部延伸的细长狭槽、可移除地储存在所述仓体中的钉,和被构造成能够沿着所述细长狭槽平移并且在钉击发行程期间将所述钉驱动到所述仓体之外的滑动件。在所述外科器械的预定动作之后,所述RFID标签不可操作。所述RFID扫描器被配置为向RFID标签发射第一信号,其中所述RFID扫描器被配置为从所述RFID标签接收响应于所述第一信号的第二信号。在所述控制器确定所述第二信号包括对应于不相容的可替换钉仓的信息时,所述控制器阻止所述外科器械的至少一个操作。
实施例集9
实施例1.一种用于与外科器械一起使用的可替换钉仓,其中所述可替换钉仓在附接到所述外科器械之前储存在包装中,其中所述包装包括第一层、第二层,和RFID系统。所述第一层和所述第二层在所述可替换钉仓周围形成密封件。所述RFID系统包括RFID标签和绝缘体。所述RFID标签附接到所述第一层,其中所述RFID标签包括集成电池、标签天线和包括已存储信息的RFID芯片。所述绝缘体附接到所述第二层,其中所述绝缘体将所述集成电池与所述RFID芯片解除电联接,其中所述绝缘体被构造成能够当所述密封件在所述第一层与所述第二层之间断开时从所述集成电池分离,并且其中在所述绝缘体与所述集成电池分离时,所述RFID标签激活并且将所述已存储信息传输到所述外科器械的RFID扫描器。
实施例2.根据实施例1所述的可替换钉仓,其中,所述外科器械的控制器将来自所述RFID标签的所传输的已存储信息与一组相容信息进行比较,并且其中如果未在所述一组相容信息中找到所传输的已存储信息,则所述控制器阻止所述外科器械执行至少一个功能。
实施例3.根据实施例2所述的可替换钉仓,其中,所述外科器械的所述至少一个功能包括钉击发行程。
实施例4.根据实施例1所述的可替换钉仓,其中,如果所述外科器械的控制器未识别来自所述RFID标签的所传输的已存储信息,则所述控制器阻止所述外科器械执行至少一个功能。
实施例5.根据实施例4所述的可替换钉仓,其中,所述外科器械的所述至少一个功能包括钉击发行程。
实施例6.根据实施例1至5中任一项所述的可替换钉仓,其中,所述RFID标签被配置为当所述绝缘体从所述集成电池分离时连续地传输所述已存储信息。
实施例7.根据实施例1至6中任一项所述的可替换钉仓,其中,所述RFID标签包括加密信息。
实施例8.根据实施例1至7中任一项所述的可替换钉仓,其中,所述RFID标签定位在电离辐射防护屏障内,并且其中所述RFID标签耐受γ消毒。
实施例9.根据实施例1至8中任一项所述的可替换钉仓,其中,所述RFID芯片的所述已存储信息包括到期日期,并且其中如果所述外科器械的控制器确定所述可替换钉仓已到期,则所述控制器阻止所述外科器械时执行至少一个功能。
实施例10.一种用于与外科器械一起使用的可替换钉仓,其中,所述可替换钉仓在附接到所述外科器械之前储存在包装中,其中所述包装包括第一层、第二层、RFID标签,和绝缘体。所述可替换钉仓定位在所述第一层和所述第二层之间。所述RFID标签包括电池、标签天线,和包括已存储信息的RFID芯片。当所述第一层从所述第二层拉开时,所述绝缘体将所述电池与所述RFID芯片解除电联接,并且其中当所述绝缘体与所述电池解除联接时,所述RFID标签激活并且将所述已存储信息传输到所述外科器械的RFID扫描器。
实施例11.根据实施例10所述的可替换钉仓,其中,所述外科器械的控制器将来自所述RFID标签的所传输的已存储信息与一组相容信息进行比较,并且其中如果未在所述一组相容信息中找到所传输的已存储信息,则所述控制器阻止所述外科器械执行至少一个功能。
实施例12.根据实施例11所述的可替换钉仓,其中,所述外科器械的所述至少一个功能包括钉击发行程。
实施例13.根据实施例10所述的可替换钉仓,其中,如果所述外科器械的控制器未识别来自所述RFID标签的所传输的已存储信息,则所述控制器阻止所述外科器械执行至少一个功能。
实施例14.根据实施例13所述的可替换钉仓,其中,所述外科器械的所述至少一个功能包括钉击发行程。
实施例15.根据实施例10至14中任一项所述的可替换钉仓,其中,所述RFID标签被配置为当所述绝缘体与所述电池分离时连续地传输所述已存储信息。
实施例16.根据实施例10至15中任一项所述的可替换钉仓,其中,所述RFID标签包括加密信息。
实施例17.根据实施例10至16中任一项所述的可替换钉仓,其中,所述RFID标签定位在电离辐射防护屏障内,并且其中所述RFID标签耐受γ消毒。
实施例18.根据实施例10至17中任一项所述的可替换钉仓,其中,所述RFID芯片的所述已存储信息包括到期日期,并且其中如果所述外科器械的控制器确定所述可替换钉仓已到期,则所述控制器阻止所述外科器械时执行至少一个功能。
实施例19.一种用于与外科器械一起使用的可替换钉仓,其中,所述可替换钉仓在附接到所述外科器械之前储存在包装中,其中所述包装包括第一层、第二层、RFID标签,和绝缘体。所述第一层和所述第二层在所述可替换钉仓周围形成密封件。所述RFID标签附接到所述可替换钉仓,其中所述RFID标签包括集成电源、标签天线,和包括已存储信息的RFID芯片。所述绝缘体附接到所述包装的所述第二层,其中所述绝缘体将所述集成电源与RFID芯片解除电联接,其中所述绝缘体被构造成能够当所述第一层从所述第二层移除时从所述集成电源分离,并且其中在所述绝缘体从所述集成电源分离时,所述RFID标签激活并且将所述已存储信息传输到所述外科器械的RFID扫描器。
实施例20.根据实施例19所述的可替换钉仓,其中,所述外科器械的控制器将来自所述RFID标签的所传输的已存储信息与一组相容信息进行比较,并且其中如果未在所述一组相容信息中找到所传输的信息,则所述控制器阻止所述外科器械执行至少一个功能。
本文所述的许多外科器械系统由电动马达促动;但是本文所述的外科器械系统可以任何合适的方式促动。在各种实例中,例如,本文所述的外科器械系统可由手动操作的触发器促动。在某些实例中,本文公开的马达可包括机器人控制系统的一部分或多个部分。此外,本文公开的任何端部执行器和/或工具组件可与机器人外科器械系统一起使用。例如,名称为“SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENTARRANGEMENTS”的美国专利申请序列号13/118,241(现为美国专利9,072,535)更详细地公开了机器人外科器械系统的若干示例并且其全文以引用方式并入本文。
已结合钉的部署和变形描述了本文所述的外科器械系统;然而,本文所述的实施方案不限于此。例如,设想了部署除钉之外的紧固件诸如夹具或大头钉的各种实施方案。此外,还设想了利用用于密封组织的任何合适装置的各种实施方案。例如,根据各种实施方案的端部执行器可包括被配置成能够加热和密封组织的电极。另外,例如,根据某些实施方案的端部执行器可施加振动能量来密封组织。
在线性端部执行器和/或线性紧固件仓的上下文中描述了本文所述的各种实施方案。此类实施方案和其教导内容可应用于非线性端部执行器和/或非线性紧固件仓,诸如例如圆形和/或波状端部执行器。例如,2011年2月28日提交的名称为“SURGICAL STAPLINGINSTRUMENT”的美国专利申请序列号13/036,647(现为美国专利申请公布2011/0226837,现为美国专利8,561,870)中公开了包括非线性端部执行器的各种端部执行器,该专利据此全文以引用方式并入。另外,2012年9月29日提交的名称为“STAPLE CARTRIDGE”的美国专利申请序列号12/893,461(现为美国专利申请公布2012/0074198)据此全文以引用方式并入。2008年2月15日提交的名称为“END EFFECTORS FOR A SURGICAL CUTTING AND STAPLINGINSTRUMENT”的美国专利申请序列号12/031,873(现为美国专利7,980,443)据此全文以引用方式并入。2013年3月12日公布的名称为“SELECTIVELY ORIENTABLE IMPLANTABLEFASTENER CARTRIDGE”的美国专利8,393,514同样据此全文以引入方式并入。
下述专利的全部公开内容据此以引用方式并入本文:
-公布于1995年4月4日的名称为“ELECTROSURGICAL HEMOSTATIC DEVICE”的美国专利5,403,312;
-公布于2006年2月21日的名称为“SURGICAL STAPLING INSTRUMENT HAVINGSEPARATE DISTINCT CLOSING AND FIRING SYSTEMS”的美国专利7,000,818;
-公布于2008年9月9日的名称为“MOTOR-DRIVEN SURGICAL CUTTING ANDFASTENING INSTRUMENT WITH TACTILE POSITION FEEDBACK”的美国专利7,422,139;
-公布于2008年12月16日的名称为“ELECTRO-MECHANICAL SURGICAL INSTRUMENTWITH CLOSURE SYSTEM AND ANVIL ALIGNMENT COMPONENTS”的美国专利7,464,849;
-公布于2010年3月2日的名称为“SURGICAL INSTRUMENT HAVING ANARTICULATING END EFFECTOR”的美国专利7,670,334;
-公布于2010年7月13日的名称为“SURGICAL STAPLING INSTRUMENTS”的美国专利7,753,245;
-公布于2013年3月12日的名称为“SELECTIVELY ORIENTABLE IMPLANTABLEFASTENER CARTRIDGE”的美国专利8,393,514;
-名称为“SURGICAL INSTRUMENT HAVING RECORDING CAPABILITIES”的美国专利申请序列号11/343,803,现为美国专利7,845,537;
-提交于2008年2月14日的名称为“SURGICAL CUTTING AND FASTENINGINSTRUMENT HAVING RF ELECTRODES”的美国专利申请序列号12/031,573;
-提交于2008年2月15日的名称为“END EFFECTORS FOR A SURGICAL CUTTING ANDSTAPLING INSTRUMENT”的美国专利申请序列号12/031,873(现为美国专利7,980,443);
-名称为“MOTOR-DRIVEN SURGICAL CUTTING INSTRUMENT”的美国专利申请序列号12/235,782,现为美国专利8,210,411;
-名称为“MOTORIZED SURGICAL INSTRUMENT”的美国专利申请序列号12/235972,现为美国专利9050083。
-名称为“POWERED SURGICAL CUTTING AND STAPLING APPARATUS WITH MANUALLYRETRACTABLE FIRING SYSTEM”的美国专利申请序列号12/249,117,现为美国专利8,608,045;
-提交于2009年12月24日的名称为“MOTOR-DRIVEN SURGICAL CUTTINGINSTRUMENT WITH ELECTRIC ACTUATOR DIRECTIONAL CONTROL ASSEMBLY”的美国专利申请序列号12/647,100,现为美国专利8,220,688;
-提交于2012年9月29日的名称为“STAPLE CARTRIDGE”的美国专利申请序列号12/893,461,现为美国专利8,733,613;
-提交于2011年2月28日的名称为“SURGICAL STAPLING INSTRUMENT”的美国专利申请序列号13/036,647,现为美国专利8,561,870;
-名称为“SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLEDEPLOYMENT ARRANGEMENTS”的美国专利申请序列号13/118,241,现为美国专利9,072,535;
-提交于2012年6月15日的名称为“ARTICULATABLE SURGICAL INSTRUMENTCOMPRISING A FIRING DRIVE”的美国专利申请序列号13/524,049,现为美国专利9,101,358;
-提交于2013年3月13日的名称为“STAPLE CARTRIDGE TISSUE THICKNESS SENSORSYSTEM”的美国专利申请序列号13/800,025,现为美国专利9,345,481;
-提交于2013年3月13日的名称为“STAPLE CARTRIDGE TISSUE THICKNESS SENSORSYSTEM”的美国专利申请序列号13/800,067,现为美国专利申请公布2014/0263552;
-提交于2006年1月31日的名称为“SURGICAL CUTTING AND FASTENINGINSTRUMENT WITH CLOSURE TRIGGER LOCKING MECHANISM”的美国专利申请公布2007/0175955;以及
-提交于2010年4月22日的名称为“SURGICAL STAPLING INSTRUMENT WITH ANARTICULATABLE END EFFECTOR”的美国专利申请公布2010/0264194,现为美国专利8,308,040。
虽然本文已结合某些实施方案描述了各种装置,但也可实施对这些实施方案的许多修改和变型。在一个或多个实施方案中,具体特征、结构或特性可以任何合适的方式进行组合。因此,在无限制的情况下,结合一个实施方案示出或描述的具体特征、结构或特性可全部或部分地与一个或多个其他实施方案的特征、结构或特性组合。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。此外,根据多种实施方案,单个部件可被替换为多个部件,并且多个部件也可被替换为单个部件,以执行给定的一种或多种功能。上述具体实施方式和下述权利要求旨在涵盖所有此类修改和变型。
本文所公开的装置可被设计成在单次使用之后废弃,或者其可被设计成多次使用。然而无论是哪种情况,该装置都可在至少使用一次后经过修整再行使用。修整可包括以下步骤的任意组合,这些步骤包括但不限于拆卸装置、之后进行装置具体部件的清洁或更换、以及随后重新组装装置。具体地,修整设施和/或外科团队可拆卸装置,并且在清洁和/或更换装置的特定部件之后,可重新组装装置以供后续使用。本领域的技术人员将会理解,修整装置可利用各种技术来进行拆卸、清洁/替换和重新组装。此类技术的使用以及所得的修复装置均在本申请的范围内。
本文所公开的装置可在手术之前进行处理。首先,可获得新的或用过的器械,并且根据需要进行清洁。然后,可对器械进行消毒。在一种消毒技术中,将所述器械放置在密闭且密封的容器(诸如,塑料或TYVEK袋)中。然后可将容器和器械置于可穿透容器的辐射场,诸如γ辐射、X射线和/或高能电子。辐射可杀死器械上和容器中的细菌。经消毒的器械随后可被储存在无菌容器中。密封容器可将器械保持为无菌的,直至在医疗设施中将该容器打开。还可使用本领域已知的任何其他技术对装置进行消毒,所述技术包括但不限于β辐射、γ辐射、环氧乙烷、等离子过氧化物和/或蒸汽。
尽管本发明已被描述为具有示例性设计,但可在本公开的实质和范围内进一步修改本发明。因此,本申请旨在涵盖使用本发明的一般原理的本发明的任何变型、用途或改型。
Claims (20)
1.一种用于与外科器械一起使用的可替换钉仓,其中所述可替换钉仓在附接到所述外科器械之前储存在包装中,其中所述包装包括:
第一层;
第二层,其中所述第一层和所述第二层在所述可替换钉仓周围形成密封件;以及
RFID系统,所述RFID系统包括:
RFID标签,所述RFID标签附接到所述第一层,其中所述
RFID标签包括:
集成电池;
标签天线;以及
RFID芯片,所述RFID芯片包括已存储信息;以及
绝缘体,所述绝缘体附接到所述第二层,其中所述绝缘体将所述集成电池与所述RFID芯片解除电联接,其中所述绝缘体被构造成能够当所述密封件在所述第一层与所述第二层之间断开时从所述集成电池分离,并且其中在所述绝缘体与所述集成电池分离时,所述RFID标签激活并且将所述已存储信息传输到所述外科器械的RFID扫描器。
2.根据权利要求1所述的可替换钉仓,其中,所述外科器械的控制器将来自所述RFID标签的所传输的已存储信息与一组相容信息进行比较,并且其中如果未在所述一组相容信息中找到所传输的已存储信息,则所述控制器阻止所述外科器械执行至少一个功能。
3.根据权利要求2所述的可替换钉仓,其中,所述外科器械的所述至少一个功能包括钉击发行程。
4.根据权利要求1所述的可替换钉仓,其中,如果所述外科器械的控制器未识别来自所述RFID标签的所传输的已存储信息,则所述控制器阻止所述外科器械执行至少一个功能。
5.根据权利要求4所述的可替换钉仓,其中,所述外科器械的所述至少一个功能包括钉击发行程。
6.根据权利要求1所述的可替换钉仓,其中,所述RFID标签被配置为当所述绝缘体从所述集成电池分离时连续地传输所述已存储信息。
7.根据权利要求1所述的可替换钉仓,其中,所述RFID标签包括加密信息。
8.根据权利要求1所述的可替换钉仓,其中,所述RFID标签定位在电离辐射防护屏障内,并且其中所述RFID标签耐受γ消毒。
9.根据权利要求1所述的可替换钉仓,其中,所述RFID芯片的所述已存储信息包括到期日期,并且其中如果所述外科器械的控制器确定所述可替换钉仓已到期,则所述控制器阻止所述外科器械时执行至少一个功能。
10.一种用于与外科器械一起使用的可替换钉仓,其中所述可替换钉仓在附接到所述外科器械之前储存在包装中,其中所述包装包括:
第一层;
第二层,其中所述可替换钉仓定位在所述第一层和所述第二层之间;
RFID标签,所述RFID标签包括:
电池;
标签天线;以及
RFID芯片,所述RFID芯片包括已存储信息;以及
绝缘体,当所述第一层从所述第二层拉开时,所述绝缘体将所述电池与所述RFID芯片解除电联接,并且其中当所述绝缘体与所述电池解除联接时,所述RFID标签激活并且将所述已存储信息传输到所述外科器械的RFID扫描器。
11.根据权利要求10所述的可替换钉仓,其中,所述外科器械的控制器将来自所述RFID标签的所传输的已存储信息与一组相容信息进行比较,并且其中如果未在所述一组相容信息中找到所传输的已存储信息,则所述控制器阻止所述外科器械执行至少一个功能。
12.根据权利要求11所述的可替换钉仓,其中,所述外科器械的所述至少一个功能包括钉击发行程。
13.根据权利要求10所述的可替换钉仓,其中,如果所述外科器械的控制器未识别来自所述RFID标签的所传输的已存储信息,则所述控制器阻止所述外科器械执行至少一个功能。
14.根据权利要求13所述的可替换钉仓,其中,所述外科器械的所述至少一个功能包括钉击发行程。
15.根据权利要求10所述的可替换钉仓,其中,所述RFID标签被配置成能够当所述绝缘体从所述电池分离时连续地传输所述已存储信息。
16.根据权利要求10所述的可替换钉仓,其中,所述RFID标签包括加密信息。
17.根据权利要求10所述的可替换钉仓,其中,所述RFID标签定位在电离辐射防护屏障内,并且其中所述RFID标签耐受γ消毒。
18.根据权利要求10所述的可替换钉仓,其中,所述RFID芯片的所述已存储信息包括到期日期,并且其中如果所述外科器械的控制器确定所述可替换钉仓已到期,则所述控制器阻止所述外科器械时执行至少一个功能。
19.一种用于与外科器械一起使用的可替换钉仓,其中所述可替换钉仓在附接到所述外科器械之前储存在包装中,其中所述包装包括:
第一层;
第二层,其中所述第一层和所述第二层在所述可替换钉仓周围形成密封件;
RFID标签,所述RFID标签附接到所述可替换钉仓,其中所述
RFID标签包括:
集成电源;
标签天线;以及
RFID芯片,所述RFID芯片包括已存储信息;以及
绝缘体,所述绝缘体附接到所述包装的所述第二层,其中所述绝缘体将所述集成电源与所述RFID芯片解除电联接,其中所述绝缘体被构造成能够当所述第一层从所述第二层移除时从所述集成电源分离,并且其中在所述绝缘体从所述集成电源分离时,所述RFID标签激活并且将所述已存储信息传输到所述外科器械的RFID扫描器。
20.根据权利要求19所述的可替换钉仓,其中,所述外科器械的控制器将来自所述RFID标签的所传输的已存储信息与一组相容信息进行比较,并且其中如果未在所述一组相容信息中找到所传输的信息,则所述控制器阻止所述外科器械执行至少一个功能。
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US16/458,103 US11771419B2 (en) | 2019-06-28 | 2019-06-30 | Packaging for a replaceable component of a surgical stapling system |
US16/458,103 | 2019-06-30 | ||
PCT/IB2020/055715 WO2020261060A1 (en) | 2019-06-28 | 2020-06-18 | Packaging for a replaceable component of a surgical stapling system |
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US11786239B2 (en) | 2021-03-24 | 2023-10-17 | Cilag Gmbh International | Surgical instrument articulation joint arrangements comprising multiple moving linkage features |
US11857183B2 (en) | 2021-03-24 | 2024-01-02 | Cilag Gmbh International | Stapling assembly components having metal substrates and plastic bodies |
US11793516B2 (en) | 2021-03-24 | 2023-10-24 | Cilag Gmbh International | Surgical staple cartridge comprising longitudinal support beam |
US11786243B2 (en) | 2021-03-24 | 2023-10-17 | Cilag Gmbh International | Firing members having flexible portions for adapting to a load during a surgical firing stroke |
US11944336B2 (en) | 2021-03-24 | 2024-04-02 | Cilag Gmbh International | Joint arrangements for multi-planar alignment and support of operational drive shafts in articulatable surgical instruments |
US11832816B2 (en) | 2021-03-24 | 2023-12-05 | Cilag Gmbh International | Surgical stapling assembly comprising nonplanar staples and planar staples |
US11896218B2 (en) | 2021-03-24 | 2024-02-13 | Cilag Gmbh International | Method of using a powered stapling device |
US11826047B2 (en) | 2021-05-28 | 2023-11-28 | Cilag Gmbh International | Stapling instrument comprising jaw mounts |
-
2019
- 2019-06-30 US US16/458,103 patent/US11771419B2/en active Active
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2020
- 2020-06-18 BR BR112021026507A patent/BR112021026507A2/pt unknown
- 2020-06-18 CN CN202080047390.1A patent/CN114126502B/zh active Active
- 2020-06-18 JP JP2021577508A patent/JP7536806B2/ja active Active
- 2020-06-18 WO PCT/IB2020/055715 patent/WO2020261060A1/en active Application Filing
- 2020-06-26 EP EP20182566.8A patent/EP3756613B1/en active Active
Patent Citations (2)
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CN101224116A (zh) * | 2007-01-10 | 2008-07-23 | 伊西康内外科公司 | 能够防止钉仓再次使用的外科器械及钉仓 |
CN109069150A (zh) * | 2016-04-18 | 2018-12-21 | 伊西康有限责任公司 | 包括闭锁件的外科器械 |
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CN114126502A (zh) | 2022-03-01 |
JP7536806B2 (ja) | 2024-08-20 |
EP3756613B1 (en) | 2024-09-25 |
US20200405296A1 (en) | 2020-12-31 |
WO2020261060A1 (en) | 2020-12-30 |
US11771419B2 (en) | 2023-10-03 |
JP2022539375A (ja) | 2022-09-08 |
BR112021026507A2 (pt) | 2022-05-10 |
EP3756613A1 (en) | 2020-12-30 |
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