CN107580472A - 用以测量组织压缩的叠加式多传感器射频(rf)电极系统 - Google Patents

用以测量组织压缩的叠加式多传感器射频(rf)电极系统 Download PDF

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CN107580472A
CN107580472A CN201680025758.8A CN201680025758A CN107580472A CN 107580472 A CN107580472 A CN 107580472A CN 201680025758 A CN201680025758 A CN 201680025758A CN 107580472 A CN107580472 A CN 107580472A
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tissue
end effector
power
sensor
signals
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CN107580472B (zh
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F·E·谢尔顿四世
D·C·亚特斯
J·L·哈里斯
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Angiotech Pharmaceuticals Inc
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Abstract

本发明公开了一种组织压缩传感器系统。该组织压缩系统包括定位在端部执行器上的RF电极,定位在该端部执行器的砧座或通道框架中的一者上的第一电触点,和以通信的方式联接到该第一电触点的第一滤波器。

Description

用以测量组织压缩的叠加式多传感器射频(RF)电极系统
背景技术
本公开涉及外科器械,并且在各种情况下,涉及被设计成用于缝合和切割组织的外科缝合和切割器械及其钉仓。
附图说明
通过结合附图来参考本公开的以下说明,本公开的特征和优点以及其获取方法将会变得更加明显,并可更好地理解本公开,其中:
图1为具有可操作地联接到其的可互换轴组件的外科器械的透视图;
图2为图1的可互换轴组件和外科器械的分解组件视图;
图3为示出图1和图2的可互换轴组件和外科器械的多个部分的另一个分解组件视图;
图4为图1至图3的外科器械的一部分的分解组件视图;
图5为图4的外科器械的一部分的横截面侧视图,其中击发触发器处于完全致动位置;
图6为图5的外科器械的一部分的另一个横截面视图,其中击发触发器处于未致动位置;
图7为可互换轴组件的一种形式的分解组件视图;
图8为图7的可互换轴组件的多个部分的另一个分解组件视图;
图9为图7和图8的可互换轴组件的多个部分的另一个分解组件视图;
图10为图7至图9的可互换轴组件的一部分的横截面视图;
图11为图7至图10的轴组件的一部分的透视图,其中为清楚起见,已省去切换筒;
图12为其上安装有切换筒的图11所示可互换轴组件部分的另一个透视图;
图13为可操作地联接到图1的外科器械的一部分的图11所示可互换轴组件的一部分的透视图,图中示出外科器械的闭合触发器处于未致动位置;
图14为图13的可互换轴组件和外科器械的右侧正视图;
图15为图13和图14的可互换轴组件和外科器械的左侧正视图;
图16为可操作地联接到图1的外科器械的一部分的图11所示可互换轴组件的一部分的透视图,图中示出外科器械的闭合触发器处于致动位置,而其击发触发器处于未致动位置;
图17为图16的可互换轴组件和外科器械的右侧正视图;
图18为图16和图17的可互换轴组件和外科器械的左侧正视图;
图18A为可操作地联接到图1的外科器械的一部分的图11所示可互换轴组件的右侧正视图,图中示出外科器械的闭合触发器处于致动位置,并且其击发触发器处于致动位置;
图19为用于当轴组件未联接到外科器械柄部的电连接器时使电连接器掉电的系统的示意图;
图20为图1的外科器械的端部执行器的一个方面的分解图;
图21A-21B为横跨两张图纸的图1的外科器械的电路图;
图22示出了功率组件的一个实例,该功率组件包括被构造成能够生成电池组的使用循环计数的使用循环电路;
图23示出了用于顺序地为分段电路通电的过程的一个方面;
图24示出了包括多个菊花链式功率转换器的功率段的一个方面;
图25示出了分段电路的一个方面,该分段电路被构造成能够使可用于关键功能和/或功率密集功能的功率最大化;
图26示出了功率系统的一个方面,该功率系统包括被构造成能够被顺序通电的多个菊花链式功率转换器;
图27示出了包括单点控制节段的分段电路的一个方面;
分成图28A和图28B的图28为图1的外科器械的电路图;
图29为图1的外科器械的框图,其中示出柄部组件14与功率组件之间、以及柄部组件14与可互换轴组件之间的接口;
图30示出了可包括本公开的一个或多个方面的示例医疗装置;
图31A示出了根据本公开的一个或多个方面的围绕组织的医疗装置的示例端部执行器;
图31B示出了根据本公开的一个或多个方面的压缩组织的医疗装置的示例端部执行器;
图32A示出了根据本公开的一个或多个方面的由压缩组织的医疗装置的端部执行器施加的示例力;
图32B也示出了根据本公开的一个或多个方面的由压缩组织的医疗装置的端部执行器施加的示例力;
图33示出了根据本公开的一个或多个方面的示例组织压缩传感器系统;
图34也示出了根据本公开的一个或多个方面的示例组织压缩传感器系统;
图35也示出了根据本公开的一个或多个方面的示例组织压缩传感器系统;
图36示出了根据本公开的一个或多个方面的示例端部执行器通道框架;
图37示出了根据本公开的一个或多个方面的示例端部执行器;
图38也示出了根据本公开的一个或多个方面的示例端部执行器通道框架;
图39也示出了根据本公开的一个或多个方面的示例端部执行器通道框架;
图40也示出了根据本公开的一个或多个方面的示例端部执行器通道框架;
图41示出了根据本公开的一个或多个方面的示例电极;
图42示出了根据本公开的一个或多个方面的示例电极接线系统;
图43也示出了根据本公开的一个或多个方面的示例端部执行器通道框架;
图44为根据本公开的一个或多个方面的示例电路图;
图45也为根据本公开的一个或多个方面的示例电路图;
图46也为根据本公开的一个或多个方面的示例电路图;
图47为示出根据本公开的一个或多个方面的示例频率调制的曲线图;
图48为示出根据本公开的一个或多个方面的复合RF信号的曲线图;
图49为示出根据本公开的一个或多个方面的滤波RF信号的曲线图;
图50为具有能够进行关节运动的可互换轴的外科器械的透视图;
图51为图76所示外科器械的末端的侧视图;
图52A-52E为绘制出随时间推移的间隙尺寸(图52A)、随时间推移的击发电流(图52B)、随时间推移的组织压缩(图52C)、随时间推移的砧座应变(图752D)、和随时间推移的触发器力(图52E)的曲线图;
图53为绘制出用于正常组织的随组织压缩而变化的组织位移的曲线图;
图54为绘制出用以区分正常组织和患病组织的随组织压缩而变化的组织位移的曲线图;
图55示出了根据一个方面的外科器械的端部执行器的剖视图。
具体实施方式
本申请的申请人拥有与本申请同日提交的下列专利申请,这些专利申请各自全文以引用方式并入本文:
-名称为“POWERED SURGICAL INSTRUMENT”的美国专利申请序列号__________;代理人案卷号END7556USNP/140481;
-名称为“MULTIPLE LEVEL THRESHOLDS TO MODIFY OPERATION OF POWEREDSURGICAL INSTRUMENTS”的美国专利申请序列号__________;代理人案卷号END7552USNP/140477;
-名称为“ADAPTIVE TISSUE COMPRESSION TECHNIQUES TO ADJUST CLOSURERATES FOR MULTIPLE TISSUE TYPES”的美国专利申请序列号__________;代理人案卷号END7557USNP/140482;
-名称为“MONITORING SPEED CONTROL AND PRECISION INCREMENTING OF MOTORFOR POWERED SURGICAL INSTRUMENTS”的美国专利申请序列号__________;代理人案卷号END7549USNP/140474;
-名称为“TIME DEPENDENT EVALUATION OF SENSOR DATA TO DETERMINESTABILITY,CREEP,AND VISCOELASTIC ELEMENTS OF MEASURES”的美国专利申请序列号__________;代理人案卷号END7559USNP/140484;
-名称为“INTERACTIVE FEEDBACK SYSTEM FOR POWERED SURGICAL INSTRUMENTS”的美国专利申请序列号__________;代理人案卷号END7555USNP/140480;
-名称为“CONTROL TECHNIQUES AND SUB-PROCESSOR CONTAINED WITHIN MODULARSHAFT WITH SELECT CONTROL PROCESSING FROM HANDLE”的美国专利申请序列号__________;代理人案卷号END7540USNP/140465;
-名称为“SMART SENSORS WITH LOCAL SIGNAL PROCESSING”的美国专利申请序列号__________;代理人案卷号END7538USNP/140463;
-名称为“SURGICAL INSTRUMENT COMPRISING A LOCKABLE BATTERY HOUSING”的美国专利申请序列号__________;代理人案卷号END7548USNP/140473;
-名称为“SYSTEM FOR DETECTING THE MIS-INSERTION OF A STAPLE CARTRIDGEINTO A SURGICAL STAPLER”的美国专利申请序列号__________;代理人案卷号END7546USNP/140471;和
-名称为“SIGNAL AND POWER COMMUNICATION SYSTEM POSITIONED ON AROTATABLE SHAFT”的美国专利申请序列号__________;代理人案卷号END7561USNP/140486。
本申请的申请人拥有2015年2月27日提交并且全文各自以引用的方式并入本文的以下专利申请:
-名称为“SURGICAL INSTRUMENT SYSTEM COMPRISING AN INSPECTION STATION”的美国专利申请序列号14/633,576;
-名称为“SURGICAL APPARATUS CONFIGURED TO ASSESS WHETHER A PERFORMANCEPARAMETER OF THE SURGICAL APPARATUS IS WITHIN AN ACCEPTABLE PERFORMANCE BAND”的美国专利申请序列号14/633,546;
-名称为“SURGICAL CHARGING SYSTEM THAT CHARGES AND/OR CONDITIONS ONEOR MORE BATTERIES”的美国专利申请序列号14/633,576;
-名称为“CHARGING SYSTEM THAT ENABLES EMERGENCY RESOLUTIONS FORCHARGING A BATTERY”的美国专利申请序列号14/633,566;
-名称为“SYSTEM FOR MONITORING WHETHER A SURGICAL INSTRUMENT NEEDS TOBE SERVICED”的美国专利申请序列号14/633,555;
-名称为“REINFORCED BATTERY FOR A SURGICAL INSTRUMENT”的美国专利申请序列号14/633,542;
-名称为“POWER ADAPTER FOR A SURGICAL INSTRUMENT”的美国专利申请序列号14/633,548;
-名称为“ADAPTABLE SURGICAL INSTRUMENT HANDLE”的美国专利申请序列号14/633,526;
-名称为“MODULAR STAPLING ASSEMBLY”的美国专利申请序列号14/633,541;和
-名称为“SURGICAL APPARATUS CONFIGURED TO TRACK AN END-OF-LIFEPARAMETER”的美国专利申请序列号14/633,562。
本申请的申请人拥有2014年12月18日提交并且全文各自以引用的方式并入本文的以下专利申请:
-名称为“SURGICAL INSTRUMENT SYSTEMS COMPRISING AN ARTICULATABLE ENDEFFECTOR AND MEANS FOR ADJUSTING THE FIRING STROKE OF A FIRING”的美国专利申请序列号14/574,478;
-名称为“SURGICAL INSTRUMENT ASSEMBLY COMPRISING LOCKABLE SYSTEMS”的美国专利申请序列号14/574,483;
-名称为“DRIVE ARRANGEMENTS FOR ARTICULATABLE SURGICAL INSTRUMENTS”的美国专利申请序列号14/575,139;
-名称为“LOCKING ARRANGEMENTS FOR DETACHABLE SHAFT ASSEMBLIES WITHARTICULATABLE SURGICAL END EFFECTORS”的美国专利申请序列号14/575,148;
-名称为“SURGICAL INSTRUMENT WITH AN ANVIL THAT IS SELECTIVELY MOVABLEABOUT A DISCRETE NON-MOVABLE AXIS RELATIVE TO A STAPLE CARTRIDGE”的美国专利申请序列号14/575,130;
-名称为“SURGICAL INSTRUMENTS WITH IMPROVED CLOSURE ARRANGEMENTS”的美国专利申请序列号14/575,143;
-名称为“SURGICAL INSTRUMENTS WITH ARTICULATABLE END EFFECTORS ANDMOVABLE FIRING BEAM SUPPORT ARRANGEMENTS”的美国专利申请序列号14/575,117;
-名称为“SURGICAL INSTRUMENTS WITH ARTICULATABLE END EFFECTORS ANDIMPROVED FIRING BEAM SUPPORT ARRANGEMENTS”的美国专利申请序列号14/575,154;
-名称为“SURGICAL INSTRUMENT ASSEMBLY COMPRISING A FLEXIBLEARTICULATION SYSTEM”的美国专利申请序列号14/574,493;以及
-名称为“SURGICAL INSTRUMENT ASSEMBLY COMPRISING A LOCKABLEARTICULATION SYSTEM”的美国专利申请序列号14/574,500。
本申请的申请人拥有提交于2013年3月1日并且各自全文以引用方式并入本文的以下专利申请:
-名称为“Articulatable Surgical Instruments With Conductive PathwaysFor Signal Communication”的美国专利申请序列号13/782,295(现为美国专利申请公布2014/0246471);
-名称为“Rotary Powered Articulation Joints For Surgical Instruments”的美国专利申请序列号13/782,323(现为美国专利申请公布2014/0246472);
-名称为“Thumbwheel Switch Arrangements For Surgical Instruments”的美国专利申请序列号13/782,338(现为美国专利申请公布2014/0249557);
-名称为“Electromechanical Surgical Device with Signal RelayArrangement”的美国专利申请序列号13/782,499(现为美国专利申请公布2014/0246474);
-名称为“Multiple Processor Motor Control for Modular SurgicalInstruments”的美国专利申请序列号13/782,460(现为美国专利申请公布2014/0246478);
-名称为“Joystick Switch Assemblies For Surgical Instruments”的美国专利申请序列号13/782,358(现为美国专利申请公布2014/0246477);
-名称为“Sensor Straightened End Effector During Removal ThroughTrocar”的美国专利申请序列号13/782,481(现为美国专利申请公布2014/0246479);
-名称为“Control Methods for Surgical Instruments with RemovableImplement Portions”的美国专利申请序列号13/782,518(现为美国专利申请公布2014/0246475);
-名称为“Rotary Powered Surgical Instruments With Multiple Degrees ofFreedom”的美国专利申请序列号13/782,375(现为美国专利申请公布2014/0246473);以及
-名称为“Surgical Instrument Soft Stop”的美国专利申请序列号13/782,536(现为美国专利申请公布2014/0246476)。
本申请的申请人还拥有2013年3月14日提交并且全文各自以引用的方式并入本文的以下专利申请:
-名称为“ARTICULATABLE SURGICAL INSTRUMENT COMPRISING A FIRING DRIVE”的美国专利申请序列号13/803,097(现为美国专利申请公布2014/0263542);
-名称为“CONTROL ARRANGEMENTS FOR A DRIVE MEMBER OF A SURGICALINSTRUMENT”的美国专利申请序列号13/803,193(现为美国专利申请公布2014/0263537);
-名称为“INTERCHANGEABLE SHAFT ASSEMBLIES FOR USE WITH A SURGICALINSTRUMENT”的美国专利申请序列号13/803,053(现为美国专利申请公布2014/0263564);
-名称为“ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATIONLOCK”的美国专利申请序列号13/803,086(现为美国专利申请公布2014/0263541);
-名称为“SENSOR ARRANGEMENTS FOR ABSOLUTE POSITIONING SYSTEM FORSURGICAL INSTRUMENTS”的美国专利申请序列号13/803,210(现为美国专利申请公布2014/0263538);
-名称为“MULTI-FUNCTION MOTOR FOR A SURGICAL INSTRUMENT”的美国专利申请序列号13/803,148(现为美国专利申请公布2014/0263554);
-名称为“DRIVE SYSTEM LOCKOUT ARRANGEMENTS FOR MODULAR SURGICALINSTRUMENTS”的美国专利申请序列号13/803,066(现为美国专利申请公布2014/0263565);
-名称为“ARTICULATION CONTROL SYSTEM FOR ARTICULATABLE SURGICALINSTRUMENTS”的美国专利申请序列号13/803,117(现为美国专利申请公布2014/0263553);
-名称为“DRIVE TRAIN CONTROL ARRANGEMENTS FOR MODULAR SURGICALINSTRUMENTS”的美国专利申请序列号13/803,130(现为美国专利申请公布2014/0263543);以及
-名称为“METHOD AND SYSTEM FOR OPERATING A SURGICAL INSTRUMENT”的美国专利申请序列号13/803,159(现为美国专利申请公布2014/0277017)。
本申请的申请人还拥有提交于2014年3月7日并且全文以引用方式并入本文的以下专利申请:
-名称为“CONTROL SYSTEMS FOR SURGICAL INSTRUMENTS”的美国专利申请序列号14/200,111(现为美国专利申请公布2014/0263539)。
本申请的申请人还拥有2014年3月26日提交并且全文各自以引用的方式并入本文的以下专利申请:
-名称为“POWER MANAGEMENT CONTROL SYSTEMS FOR SURGICAL INSTRUMENTS”的美国专利申请序列号14/226,106;
-名称为“STERILIZATION VERIFICATION CIRCUIT”的美国专利申请序列号14/226,099;
-名称为“VERIFICATION OF NUMBER OF BATTERY EXCHANGES/PROCEDURE COUNT”的美国专利申请序列号14/226,094;
-名称为“POWER MANAGEMENT THROUGH SLEEP OPTIONS OF SEGMENTED CIRCUITAND WAKE UP CONTROL”的美国专利申请序列号14/226,117;
-名称为“MODULAR POWERED SURGICAL INSTRUMENT WITH DETACHABLE SHAFTASSEMBLIES”的美国专利申请序列号14/226,075;
-名称为“FEEDBACK ALGORITHMS FOR MANUAL BAILOUT SYSTEMS FOR SURGICALINSTRUMENTS”的美国专利申请序列号14/226,093;
-名称为“SURGICAL INSTRUMENT UTILIZING SENSOR ADAPTATION”的美国专利申请序列号14/226,116;
-名称为“SURGICAL INSTRUMENT CONTROL CIRCUIT HAVING A SAFETYPROCESSOR”的美国专利申请序列号14/226,071;
-名称为“SURGICAL INSTRUMENT COMPRISING INTERACTIVE SYSTEMS”的美国专利申请序列号14/226,097;
-名称为“INTERFACE SYSTEMS FOR USE WITH SURGICAL INSTRUMENTS”的美国专利申请序列号14/226,126;
-名称为“MODULAR SURGICAL INSTRUMENT SYSTEM”的美国专利申请序列号14/226,133;
-名称为“SYSTEMS AND METHODS FOR CONTROLLING A SEGMENTED CIRCUIT”的美国专利申请序列号14/226,081;
-名称为“POWER MANAGEMENT THROUGH SEGMENTED CIRCUIT AND VARIABLEVOLTAGE PROTECTION”的美国专利申请序列号14/226,076;
-名称为“SURGICAL STAPLING INSTRUMENT SYSTEM”的美国专利申请序列号14/226,111;以及
-名称为“SURGICAL INSTRUMENT COMPRISING A ROTATABLE SHAFT”的美国专利申请序列号14/226,125。
本申请的申请人还拥有提交于2014年9月5日并且各自全文以引用方式并入本文的以下专利申请:
-名称为“CIRCUITRY AND SENSORS FOR POWERED MEDICAL DEVICE”的美国专利申请序列号14/479,103;
-名称为“ADJUNCT WITH INTEGRATED SENSORS TO QUANTIFY TISSUECOMPRESSION”的美国专利申请序列号14/479,119;
-名称为“MONITORING DEVICE DEGRADATION BASED ON COMPONENT EVALUATION”的美国专利申请序列号14/478,908;
-名称为“MULTIPLE SENSORS WITH ONE SENSOR AFFECTING A SECOND SENSOR'SOUTPUT OR INTERPRETATION”的美国专利申请序列号14/478,895;
-名称为“USE OF POLARITY OF HALL MAGNET DETECTION TO DETECT MISLOADEDCARTRIDGE”的美国专利申请序列号14/479,110;
-名称为“SMART CARTRIDGE WAKE UP OPERATION AND DATA RETENTION”的美国专利申请序列号14/479,098;
-名称为“MULTIPLE MOTOR CONTROL FOR POWERED MEDICAL DEVICE”的美国专利申请序列号14/479,115;以及
-名称为“LOCAL DISPLAY OF TISSUE PARAMETER STABILIZATION”的美国专利申请序列号14/479,108。
本申请的申请人还拥有2014年4月9日提交并且全文各自以引用的方式并入本文的以下专利申请:
-名称为“MOTOR DRIVEN SURGICAL INSTRUMENTS WITH LOCKABLE DUAL DRIVESHAFTS”的美国专利申请序列号14/248,590(现为美国专利申请公布2014/0305987);
-名称为“SURGICAL INSTRUMENT COMPRISING A CLOSING DRIVE AND A FIRINGDRIVE OPERATED FROM THE SAME ROTATABLE OUTPUT”的美国专利申请序列号14/248,581(现为美国专利申请公布2014/0305989);
-名称为“SURGICAL INSTRUMENT SHAFT INCLUDING SWITCHES FOR CONTROLLINGTHE OPERATION OF THE SURGICAL INSTRUMENT”的美国专利申请序列号14/248,595(现为美国专利申请公布2014/0305988);
-名称为“POWERED LINEAR SURGICAL STAPLER”的美国专利申请序列号14/248,588(现为美国专利申请公布2014/0309666);
-名称为“TRANSMISSION ARRANGEMENT FOR A SURGICAL INSTRUMENT”的美国专利申请序列号14/248,591(现为美国专利申请公布2014/0305991);
-名称为“MODULAR MOTOR DRIVEN SURGICAL INSTRUMENTS WITH ALIGNMENTFEATURES FOR ALIGNING ROTARY DRIVE SHAFTS WITH SURGICAL END EFFECTOR SHAFTS”的美国专利申请序列号14/248,584(现为美国专利申请公布2014/0305994);
-名称为“POWERED SURGICAL STAPLER”的美国专利申请序列号14/248,587(现为美国专利申请公布2014/0309665);
-名称为“DRIVE SYSTEM DECOUPLING ARRANGEMENT FOR A SURGICALINSTRUMENT”的美国专利申请序列号14/248,586(现为美国专利申请公布2014/0305990);以及
-名称为“MODULAR MOTOR DRIVEN SURGICAL INSTRUMENTS WITH STATUSINDICATION ARRANGEMENTS”的美国专利申请序列号14/248,607(现为美国专利申请公布2014/0305992)。
本申请的申请人还拥有2013年4月16日提交并且全文各自以引用的方式并入本文的以下专利申请:
-名称为“SURGICAL INSTRUMENT WITH MULTIPLE FUNCTIONS PERFORMED BY ASINGLE MOTOR”的美国临时专利申请序列号61/812,365;
-名称为“LINEAR CUTTER WITH POWER”的美国临时专利申请序列号61/812,376;
-名称为“LINEAR CUTTER WITH MOTOR AND PISTOL GRIP”的美国临时专利申请序列号61/812,382;
-名称为“SURGICAL INSTRUMENT HANDLE WITH MULTIPLE ACTUATION MOTORS ANDMOTOR CONTROL”的美国临时专利申请序列号61/812,385;以及
-名称为“SURGICAL INSTRUMENT WITH MULTIPLE FUNCTIONS PERFORMED BY ASINGLE MOTOR”的美国临时专利申请序列号61/812,372。
本公开提供了对本文所公开的装置和方法的结构、功能、制造和使用的原理的全面理解。这些方面的一个或多个示例已在附图中示出。本领域的普通技术人员应当理解,本文具体描述并且示于附图中的装置和方法均为非限制性的示例。结合一个示例示出或描述的特征可与其他示例的特征进行组合。此类修改和变型旨在被包括在本公开的范围内。
本说明书通篇提及的“各个方面”、“一些方面”、“一个方面”或“方面”等,意指结合该方面描述的具体特征、结构或特性包括在至少一个方面中。因此,本说明书通篇出现的短语“在各个方面”、“在一些方面”、“在一个方面”或“在某个方面”等并不一定都指相同的方面。此外,具体特征、结构或特性可在一个或多个方面以任何合适的方式组合。因此,在无限制的情形下,结合一个方面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方面的特征、结构或特性组合。此类修改和变型旨在被包括在本公开的范围内。
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,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位置使用,并且这些术语并非限制性和/或绝对化的。
提供各种示例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和细长轴可通过该工作通道推进。
图1至图6示出了可再利用或不可再利用的马达驱动外科切割和紧固器械10。在示出的示例中,器械10包括外壳12,该外壳包括被构造成能够被临床医生抓握、操纵和致动的柄部组件14。外壳12被构造用于可操作地附接到可互换轴组件200,该可互换轴组件上可操作地联接有外科端部执行器300,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外科手术。继续参阅本具体实施方式,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颖的构造也可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,该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”可指手持外科器械的一部分。术语“框架”也可代表机器人控制的外科器械的一部分和/或可用于操作地控制外科器械的机器人系统的一部分。例如,本文所公开的可互换轴组件可与名称为“SURGICAL STAPLINGINSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS”的美国专利申请序列号13/118,241(现为美国专利申请公布US 2012/0298719)中公开的各种机器人系统、器械、部件和方法一起使用。名称为“SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLEDEPLOYMENT ARRANGEMENTS”的美国专利申请序列号13/118,241(现为美国专利申请公布US2012/0298719)全文以引用方式并入本文。
图1至图3中所示的外壳12结合包括端部执行器300的可互换轴组件200示出,该端部执行器包括被构造成能够可操作地支撑其中的外科钉仓304的外科切割和紧固装置。外壳12可被构造用于结合可互换轴组件使用,该可互换轴组件包括适于支撑不同尺寸和类型的钉仓的端部执行器,并具有不同的轴长度、尺寸和类型等。此外,外壳12也可有效地与多种其他可互换轴组件一起使用,该其他可互换轴组件包括被构造成能够将其他动作和能量形式(诸如,射频(RF)能量、超声能量和/或动作)施加到适于结合各种外科应用和外科手术使用的端部执行器构造的那些组件。此外,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何合适的一个或多个紧固件来紧固组织。例如,包括多个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。
图1示出了具有可操作地联接到其的可互换轴组件200的外科器械10。图2和图3示出可互换轴组件200至外壳12或柄部组件14的附接。如图4所示,柄部组件14可包括一对可互连柄部外壳段16和18,该对柄部外壳段可通过螺钉、按扣特征结构、粘合剂等互连。在所示构造中,柄部外壳段16、18配合以形成可被临床医生抓握和操纵的手枪式握把部19。如将在下文更详细所述,柄部组件14在其中可操作地支撑多个驱动系统,该多个驱动系统被构造成能够生成并将各种控制动作施加到可操作地附接到其的可互换轴组件的对应部分。
现在参见图4,柄部组件14还可包括可操作地支撑多个驱动系统的框架20。例如,框架20能够可操作地支撑通常标示为30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和打开动作施加到可操作地附接或联接到其的可互换轴组件200。在至少一种形式中,闭合驱动系统30可包括被框架20可枢转地支撑的闭合触发器32形式的致动器。更具体地,如图4所示,闭合触发器32经由销33可枢转地联接到外壳14。此类构造允许闭合触发器32被临床医生操纵,使得当临床医生抓握柄部组件14的手枪式握把部19时,闭合触发器32可被其轻易地从起始或“未致动”位置枢转到“致动”位置,更具体地,枢转到完全压缩或完全致动位置。闭合触发器32可被弹簧或其他偏置构造(未示出)偏置到未致动位置。在各种形式中,闭合驱动系统30还包括可枢转地联接到闭合触发器32的闭合连杆组件34。如图4所示,闭合连杆组件34可包括由销35枢转地联接到闭合触发器32的第一闭合连杆36和第二闭合连杆38。第二闭合连杆38在本文中也可称为“附接构件”并且包括横向附接销37。
仍参见图4,可观察到,第一闭合连杆36可在其上具有锁定壁或锁定端39,该锁定壁或锁定端被构造成能够与可枢转地联接到框架20的闭合释放组件60配合。在至少一种形式中,闭合释放组件60可包括具有在其上形成的朝远侧突起的锁定棘爪64的释放按钮组件62。释放按钮组件62可被释放弹簧(未示出)沿逆时针方向枢转。当临床医生将闭合触发器32从其未致动位置朝柄部组件14的手枪式握把部19按压时,第一闭合连杆36向上枢转到某个点,其中锁定棘爪64落入该点中以与第一闭合连杆36上的锁定壁39保持接合,从而阻止闭合触发器32返回到未致动位置。参见图18。因此,闭合释放组件60用来将闭合触发器32锁定在完全致动位置。当临床医生期望将闭合触发器32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62,使得锁定棘爪64运动成与第一闭合连杆36上的锁定壁39脱离接合。当锁定棘爪64已运动成与第一闭合连杆36脱离接合时,闭合触发器32可枢转回到未致动位置。也可采用其他闭合触发器锁定和释放构造。
除上述之外,图13至图15示出了处于未致动位置的闭合触发器32,该未致动位置与轴组件200的打开或未夹紧构型相关联,在该构型中,组织可定位在轴组件200的钳口之间。图16至图18示出了处于致动位置的闭合触发器32,该致动位置与轴组件200的闭合或夹持构型相关联,在该构型中,组织被夹持在轴组件200的钳口之间。读者在将图14与图17比较之后将会知道,当闭合触发器32从其未致动位置(图14)向其致动位置(图17)运动时,闭合释放按钮62在第一位置(图14)与第二位置(图17)之间枢转。闭合释放按钮62的旋转可称为向上旋转,然而,闭合释放按钮62的至少一部分朝向电路板100旋转。参见图4,闭合释放按钮62可包括从其延伸的臂61和例如安装到臂61的磁性元件63,诸如永磁体。当闭合释放按钮62从其第一位置旋转到其第二位置时,磁性元件63可朝向电路板100运动。电路板100可包括被构造成能够检测磁性元件63的运动的至少一个传感器。在至少一个方面,磁场传感器65例如可安装到电路板100的底部表面。磁场传感器65可被构造成能够检测由磁性元件63的运动引起、环绕磁场传感器65的磁场变化。磁场传感器65可例如与微控制器1500(图19)进行信号通信,该微控制器可确定闭合释放按钮62是处于其第一位置、其第二位置,和/或第一位置与第二位置之间的任何位置,该第一位置与闭合触发器32的未致动位置和端部执行器的打开构型相关联,该第二位置与闭合触发器32的致动位置和端部执行器的闭合构型相关联。
如本公开通篇所用,磁场传感器可为霍尔效应传感器、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。
在至少一种形式中,柄部组件14和框架20可以可操作地支撑在本文中称为击发驱动系统80的另一个驱动系统,该驱动系统被构造成能够将击发动作施加到附接到其上的可互换轴组件的对应部分。击发驱动系统80在本文中也可称为“第二驱动系统”。击发驱动系统80可采用位于柄部组件14的手枪式握把部19中的电动马达82。在各种形式中,马达82可为直流有刷驱动马达,其具有大约例如25,000RPM的最大转速。在其他构造中,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。马达82可由电源90供电,在一种形式中,该电源可包括可移除电源组92。如图4所示,例如,电源组92可包括近侧外壳部分94,该近侧外壳部分被构造用于附接到远侧外壳部分96。近侧外壳部分94和远侧外壳部分96被构造成能够可操作地支撑其中的多个电池98。电池98各自可包括例如锂离子(“LI”)或其他合适的电池。远侧外壳部分96被构造成用于以可移除方式可操作地附接到同样可操作地联接到马达82的控制电路板组件100。可使用可串联连接的多个电池98作为外科器械10的电源。此外,电源90可为可更换的和/或可再充电的。
如上面相对于其他各种形式所概述,电动马达82可包括与齿轮减速器组件84可操作地交接的可旋转轴(未示出),该齿轮减速器组件被安装成与纵向可动驱动构件120上的一组或一齿条的驱动齿122啮合接合。在使用中,电源90所提供的电压极性可沿顺时针方向操作电动马达82,其中由电池施加给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82。当电动马达82沿一个方向旋转时,驱动构件120将沿远侧方向“DD”被轴向地驱动。当马达82被沿相反的旋转方向驱动时,驱动构件120将沿近侧方向“PD”被轴向地驱动。柄部组件14可包括开关,该开关被构造成能够使由电源90施加到电动马达82的极性反转。与本文所述的其他形式一样,柄部组件14还可包括传感器,该传感器被构造成能够检测驱动构件120的位置和/或驱动构件120运动的方向。
马达82的致动可由被枢转地支撑在柄部组件14上的击发触发器130控制。击发触发器130可在未致动位置和致动位置之间枢转。击发触发器130可被弹簧132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130时,击发触发器可被弹簧132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130可定位在闭合触发器32“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134可经由销35枢转地安装到闭合触发器32。安全按钮134可定位在击发触发器130和闭合触发器32之间,并且具有从其突起的枢转臂136。参见图4。当闭合触发器32处于未致动位置时,安全按钮134被容纳在柄部组件14中,此时临床医生可能无法轻易地触及所述按钮并使其在防止对击发触发器130致动的安全位置与其中击发触发器130可被击发的击发位置之间运动。当临床医生按压闭合触发器32时,安全按钮134和击发触发器130向下枢转,其中它们随后可被临床医生操纵。
如上文所讨论,柄部组件14可包括闭合触发器32和击发触发器130。参见图14至图18A,击发触发器130能够可枢转地安装到闭合触发器32。闭合触发器32可包括从其延伸的臂31,击发触发器130可围绕枢轴销33可枢转地安装到臂31。如上文所概述,当闭合触发器32从其未致动位置(图14)向其致动位置(图17)运动时,击发触发器130可向下下降。在安全按钮134已运动到其击发位置之后,主要参见图18A,可按压击发触发器130,以操作外科器械击发系统的马达。在各种情况下,柄部组件14可包括跟踪系统,例如诸如系统800,该跟踪系统被构造成能够确定闭合触发器32的位置和/或击发触发器130的位置。主要参照图14、图17和图18A,跟踪系统800可包括磁性元件,例如诸如永磁体802,该磁性元件安装到从击发触发器130延伸的臂801。跟踪系统800可包括一个或多个传感器,例如诸如第一磁场传感器803和第二磁场传感器804,这些传感器可被构造成能够跟踪磁体802的位置。
读者在将图14与图17比较之后将会知道,当闭合触发器32从其未致动位置向其致动位置运动时,磁体802可在与第一磁场传感器803相邻的第一位置和与第二磁场传感器804相邻的第二位置之间运动。
读者在将图17与图18A比较之后将进一步知道,当击发触发器130从未击发位置(图17)向击发位置(图18A)运动时,磁体802可相对于第二磁场传感器804运动。传感器803和804可跟踪磁体802的运动,并且可与电路板100上的微控制器进行信号通信。微控制器可利用来自第一传感器803和/或第二传感器804的数据,确定磁体802沿预定义的路径的位置,并且微控制器可基于该位置,确定闭合触发器32是处于其未致动位置、其致动位置、还是其未致动位置和其致动位置之间的位置。相似地,微控制器可利用来自第一传感器803和/或第二传感器804的数据,确定磁体802沿预定义的路径的位置,并且微控制器可基于该位置,确定击发触发器130是处于其未击发位置、其完全击发位置、还是其未击发位置和其完全击发位置之间的位置。
如上所述,在至少一种形式中,可纵向运动的驱动构件120具有在其上形成的一齿条的齿122,以用于与齿轮减速器组件84的相应驱动齿轮86啮合接合。至少一种形式还包括可手动致动的“应急”组件140,该组件被构造成能够允许临床医生在马达82万一变成被停用时手动地缩回可纵向运动的驱动构件120。应急组件140可包括杠杆或应急柄部组件14,该杠杆或应急柄部组件被构造成能够被手动地枢转为与同样设置在驱动构件120中的齿124棘轮接合。因此,临床医生可使用应急柄部组件14手动地缩回驱动构件120,以使驱动构件120沿近侧方向“PD”进行棘轮运动。美国专利申请公布US 2010/0089970(现为美国专利8,608,045)公开了应急构造和也可与本文所公开的各种器械一起使用的其他部件、构造和系统。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(美国专利申请公布2010/0089970,现在为美国专利8,608,045)全文以引用方式并入本文。
现在转到图1和图7,可互换轴组件200包括外科端部执行器300,该外科端部执行器包括被构造成能够可操作地支撑其中的钉仓304的细长通道302。端部执行器300还可包括砧座306,该砧座相对于细长通道302可枢转地支撑。可互换轴组件200还可包括关节运动接头270和关节运动锁350(图8),该关节运动锁可被构造成能够将端部执行器300相对于轴轴线SA-SA可释放地保持在期望的位置。有关端部执行器300、关节运动接头270和关节运动锁350的构造和操作的细节,在2013年3月14日提交的名称为“ARTICULATABLE SURGICALINSTRUMENT COMPRISING AN ARTICULATION LOCK”的美国专利申请序列号13/803,086(现为美国专利申请公布2014/0263541)中示出。2013年3月14日提交的名称为“ARTICULATABLESURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK”的美国专利申请序列号13/803,086(现为美国专利申请公布2014/0263541)的整个公开内容全文以引用的方式并入本文。如图7和图8所示,可互换轴组件200还可包括由喷嘴部分202和203构成的近侧外壳或喷嘴201。可互换轴组件200还可包括闭合管260,该闭合管可用于闭合和/或打开端部执行器300的砧座306。现在主要参见图8和图9,轴组件200可包括脊210,该脊可被构造成能够可固定地支撑关节运动锁350的轴框架部分212。参见图8。脊210可被构造成能够:第一,可滑动地支撑其中的击发构件220;第二,可滑动地支撑围绕脊210延伸的闭合管260。脊210还被构造成能够可滑动地支撑近侧关节运动驱动器230。关节运动驱动器230具有远侧端部231,该远侧端部被构造成能够可操作地接合关节运动锁350。关节运动锁350与关节运动框架352交接,该关节运动框架能够可操作地接合端部执行器框架(未示出)上的驱动销(未示出)。如上所述,有关关节运动锁350和关节运动框架的操作的更多细节可见于美国专利申请序列号13/803,086(现为美国专利申请公布2014/0263541)中。在各种情况下,脊210可包括可旋转地支撑在底座240中的近侧端部211。在一种构造中,例如,脊210的近侧端部211具有在其上形成的螺纹214,以便通过螺纹附接到脊轴承216,该脊轴承被构造成能够被支撑在底座240内。参见图7。这种构造有利于将脊210可旋转地附接到底座240,使得脊210可相对于底座240围绕轴轴线SA-SA选择性地旋转。
主要参见图7,可互换轴组件200包括闭合梭动件250,该闭合梭动件以可相对于底座240轴向运动的方式可滑动地支撑在该底座内。如图3和图7所示,闭合梭动件250包括被构造成能够附接到附接销37的一对朝近侧突起的钩252,该附接销附接到第二闭合连杆38,如将在下文进一步详细地讨论。闭合管260的近侧端部261联接到闭合梭动件250以用于相对于其旋转。例如,将U形连接器263插入闭合管260的近侧端部261中的环形狭槽262中,使其保留在闭合梭动件250中的竖直狭槽253内。参见图7。此类构造用于将闭合管260附接到闭合梭动件250,以用于与闭合梭动件一起轴向行进,同时使闭合管260能够围绕轴轴线SA-SA相对于闭合梭动件250旋转。闭合弹簧268轴颈连接在闭合管260上并且用于沿近侧方向“PD”偏置闭合管260,当轴组件可操作地联接到柄部组件14时,该闭合弹簧可用于将闭合触发器枢转到未致动位置。
在至少一种形式中,可互换轴组件200还可包括关节运动接头270。然而,其他可互换轴组件可能无法进行关节运动。如图7所示,例如,关节运动接头270包括双枢轴闭合套管组件271。根据各种形式,双枢轴闭合套管组件271包括具有朝远侧突出的上柄脚273和下柄脚274的端部执行器闭合套管组件272。端部执行器闭合套管组件272包括马蹄形孔275和插片276,以用于按2013年3月14日提交的名称为“ARTICULATABLE SURGICAL INSTRUMENTCOMPRISING AN ARTICULATION LOCK”的美国专利申请序列号13/803,086(现为美国专利申请公布2014/0263541,该专利申请以引用方式并入本文)中所述的各种方式接合砧座306上的开口插片。如本文进一步详细地描述,当砧座306打开时,马蹄形孔275和插片276与砧座上的插片接合。上部双枢轴连杆277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闭合管260上的朝近侧突出的上柄脚273中的上部远侧销孔以及朝远侧突出的上柄脚264中的上部近侧销孔。下部双枢轴连杆278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朝近侧突出的下柄脚274中的下部远侧销孔以及朝远侧突出的下柄脚265中的下部近侧销孔。另外参见图8。
在使用中,闭合管260朝远侧(方向“DD”)平移,以(例如)响应于闭合触发器32的致动而闭合砧座306。通过朝远侧平移闭合管260,因而平移轴闭合套管组件272,致使轴闭合套管组件按前述参考文献美国专利申请序列号13/803,086(现为美国专利申请公布2014/0263541)中所述的方式冲击砧座360上的近侧表面,由此闭合砧座306。还如该参考文献所详述,通过朝近侧平移闭合管260和轴闭合套管组件272,致使插片276和马蹄形孔275接触并推压砧座插片以将砧座306抬起,由此打开砧座306。在砧座打开位置,轴闭合管260移动至其近侧位置。
如上所述,外科器械10还可包括其类型和构造在美国专利申请序列号13/803,086(现为美国专利申请公布2014/0263541)中进一步详细描述的关节运动锁350,该关节运动锁可被构造成能够操作以将端部执行器300选择性地锁定在适当的位置。当关节运动锁350处于其解锁状态时,这种构造使端部执行器300能够相对于轴闭合管260旋转或做关节运动。在这种解锁状态下,端部执行器300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300相对于闭合管260做关节运动。端部执行器300也可在关节运动驱动器230作用下,相对于闭合管260进行关节运动。
同样如上所述,可互换轴组件200还包括击发构件220,该击发构件被支撑以便在轴脊210内轴向行进。击发构件220包括被构造成能够附接到远侧切割部分或刀杆280的中间击发轴部分222。击发构件220在本文中也可称为“第二轴”和/或“第二轴组件”。如图8和图9所示,中间击发轴部分222可在其远侧端部中包括纵向狭槽223,该纵向狭槽可被构造成能够接收远侧刀杆280的近侧端部282上的插片284。纵向狭槽223和近侧端部282可被设定尺寸并被构造成能够允许两者间的相对运动,并且可包括滑动接头286。滑动接头286可允许击发驱动装置220的中间击发轴部分222运动,以在不运动或至少基本上不运动刀杆280的情况下,使端部执行器300做关节运动。一旦端部执行器300已被适当地取向,中间击发轴部分222就可朝远侧推进,直到纵向狭槽223的近侧侧壁接触到插片284,以便推进刀杆280并击发定位在通道302内的钉仓。如图8和图9中可进一步看到的那样,轴脊210在其中具有细长的开口或窗口213,以利于把中间击发轴部分222装配进轴框架210以及插入该轴框架中。一旦中间击发轴部分222已被插入轴框架中,顶部框架段215就可与轴框架212接合,以封闭其中的中间击发轴部分222与刀杆280。有关击发构件220的操作的进一步描述可见于美国专利申请序列号13/803,086(现为美国专利申请公布2014/0263541)中。
除上述之外,轴组件200可包括离合器组件400,该离合器组件可被构造成能够将关节运动驱动器230选择性地和可释放地联接到击发构件220。在一种形式中,离合器组件400包括围绕击发构件220定位的锁定衬圈或锁定套管402,其中锁定套管402可在接合位置与脱离位置之间旋转,在该接合位置,锁定套管402将关节运动驱动器360联接到击发构件220,在该脱离位置,关节运动驱动器360没有可操作地联接到击发构件200。当锁定套管402处于其接合位置时,击发构件220的远侧运动可使关节运动驱动器360朝远侧运动,相应地,击发构件220的近侧运动可使关节运动驱动器230朝近侧运动。当锁定套管402处于其脱离位置时,击发构件220的运动不传递到关节运动驱动器230,因此,击发构件220可独立于关节运动驱动器230运动。在各种情况下,当击发构件220没有使关节运动驱动器230在近侧方向或远侧方向上运动时,关节运动驱动器230可被关节运动锁350保持就位。
主要参见图9,锁定套管402可包括圆柱形或至少基本上圆柱形的主体,该主体包括限定于其中、被构造成能够接收击发构件220的纵向孔403。锁定套管402可包括面向内的锁定突起404和面向外的锁定构件406,这两者沿直径相对。锁定突起404可被构造成能够与击发构件220选择性地接合。更具体地,锁定套管402处于其接合位置时,锁定突起404被定位在击发构件220中限定的驱动凹口224内,使得远侧推力和/或近侧拉力可从击发构件220传递到锁定套管402。当锁定套管402处于其接合位置时,第二锁定构件406被接收在关节运动驱动器230中限定的驱动凹口232内,使得施加到锁定套管402的远侧推力和/或近侧拉力可传递到关节运动驱动器230。实际上,当锁定套管402处于其接合位置时,击发构件220、锁定套管402和关节运动驱动器230将一起运动。另一方面,当锁定套管402处于其脱离位置时,锁定突起404可以不定位在击发构件220的驱动凹口224内,因此,远侧推力和/或近侧拉力可以不从击发构件220传递到锁定套管402。相应地,远侧推力和/或近侧拉力可以不传递到关节运动驱动器230。在此类情况下,击发构件220可相对于锁定套管402和近侧关节运动驱动器230朝近侧和/或朝远侧滑动。
如图8-12所示,轴组件200还包括可旋转地接收在闭合管260上的切换筒500。切换筒500包括中空轴段502,该中空轴段具有在其上形成的轴凸台504,用于将向外突起的致动销410接收在其中。在各种情况下,致动销410延伸穿过狭槽267进入设置在锁套管402中的纵向狭槽408,以在锁套管402与关节运动驱动器230接合时,利于该锁套管做轴向移动。旋转扭转弹簧420被构造成能够如图10所示接合切换筒500上的凸台504以及喷嘴外壳203的一部分,以将偏置力施加到切换筒500。参见图5和图6,切换筒500还可包括其中限定的至少部分周边的开口506,这些开口可被构造成能够接收从喷嘴半部202,203延伸的周边安装架204,205,并允许切换筒500与近侧喷嘴201之间相对旋转而不是相对平移。如这些图所示,安装架204和205还延伸穿过闭合管260中的开口266以安置在轴脊210中的凹陷部211中。然而,喷嘴201旋转到某个点(在该点处,安装架204、205到达它们各自的狭槽506在切换筒500中的末端)将导致切换筒500围绕轴轴线SA-SA旋转。切换筒500的旋转最终将引起致动销410旋转,并引起锁定套管402在其接合位置与脱离位置之间旋转。因此,实质上,喷嘴201可用于以在美国专利申请序列号13/803,086(现为美国专利申请公布2014/0263541)中更详细描述的各种方式来使关节运动驱动系统与击发驱动系统操作地接合和脱离接合。
也如图8至图12所示,轴组件200可包括滑环组件600,例如,该滑环组件可被构造成能够将电力传导至端部执行器300和/或从该端部执行器传导电力,和/或将信号传送至端部执行器300和/或从该端部执行器300接收信号。滑环组件600可包括近侧连接器凸缘604和远侧连接器凸缘601,该近侧连接器凸缘安装到从底座240延伸的底座凸缘242,该远侧连接器凸缘定位在轴外壳202,203中限定的狭槽内。近侧连接器凸缘604可包括第一面,并且远侧连接器凸缘601可包括第二面,其中第二面与第一面相邻定位,并能够相对于第一面运动。远侧连接器凸缘601可围绕轴轴线SA-SA相对于近侧连接器凸缘604旋转。近侧连接器凸缘604可包括限定在其第一面中的多个同心或至少基本上同心的导体602。连接器607可安装在连接器凸缘601的近侧侧面上,并可具有多个触点(未示出),其中每个触点与导体602中的一者相对应并与其电接触。这种构造在保持近侧连接器凸缘604与远侧连接器凸缘601之间电接触的同时,允许这两个凸缘之间相对旋转。例如,近侧连接器凸缘604可包括电连接器606,该电连接器可将导体602放置成与安装到轴底座240的轴电路板610进行信号通信。在至少一种情况下,包括多个导体的线束可在电连接器606与轴电路板610之间延伸。电连接器606可朝近侧延伸穿过限定在底座安装凸缘242中的连接器开口243。参见图7。2013年3月13日提交的名称为“STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM”的美国专利申请序列号13/800,067(现在为美国专利申请公布2014/0263552)全文以引用方式并入。2013年3月13日提交的名称为“STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM”的美国专利申请序列号13/800,025(现在为美国专利申请公布2014/0263551)全文以引用方式并入。有关滑环组件600的更多细节可见于美国专利申请序列号13/803,086(现为美国专利申请公布2014/0263541)中。
如上文所讨论,轴组件200可包括可固定地安装到柄部组件14的近侧部分和可围绕纵向轴线旋转的远侧部分。如上文所讨论,可旋转的远侧轴部分可围绕滑环组件600相对于近侧部分旋转。滑环组件600的远侧连接器凸缘601可定位在可旋转的远侧轴部分内。而且,除上述之外,切换筒500也可定位在可旋转的远侧轴部分内。当可旋转的远侧轴部分旋转时,远侧连接器凸缘601和切换筒500可彼此同步地旋转。另外,切换筒500可相对于远侧连接器凸缘601在第一位置与第二位置之间旋转。当切换筒500处于其第一位置时,关节运动驱动系统可与击发驱动系统可操作地脱离接合,因此,击发驱动系统的操作可使轴组件200的端部执行器300不进行关节运动。当切换筒500处于其第二位置时,关节运动驱动系统能够可操作地与击发驱动系统接合,因此,击发驱动系统的操作可以使轴组件200的端部执行器300做关节运动。当切换筒500在其第一位置和其第二位置之间运动时,切换筒500相对于远侧连接器凸缘601运动。在各种情况下,轴组件200可包括被构造成能够检测切换筒500的位置的至少一个传感器。现在转到图11和图12,远侧连接器凸缘601可包括例如磁场传感器605,并且切换筒500可包括例如磁性元件,诸如永磁体505。磁场传感器605可被构造成能够检测永磁体505的位置。当切换筒500在其第一位置和其第二位置之间旋转时,永磁体505可相对于磁场传感器605运动。在各种情况下,磁场传感器605可检测当永磁体505运动时产生的磁场变化。磁场传感器605可与例如轴电路板610和/或柄部电路板100进行信号通信。基于来自磁场605的信号,轴电路板610和/或柄部电路板100上的微控制器可确定关节运动驱动系统是与击发驱动系统接合还是脱离。
再次参见图3和图7,底座240包括在其上形成的至少一个、优选地两个锥形附接部分244,该锥形附接部分适于被接收在对应的燕尾形狭槽702内,该燕尾形狭槽在框架20的远侧附接凸缘部分700内形成。每个燕尾形狭槽702可以是锥形,或换句话讲,可以略成V形,从而以坐置方式将附接部分244接收在其中。如图3和图7中可进一步看到的那样,轴附接耳状物226在中间击发轴222的近侧端部上形成。如将在下文进一步详细地讨论,当可互换轴组件200联接到柄部组件14时,轴附接耳状物226被接收在纵向驱动构件120的远侧端部125中形成的击发轴附接支架126中,如例如图3和图6所示。
各种轴组件采用闩锁系统710以可移除地将轴组件200联接到外壳12,更具体地,联接到框架20。如图7所示,例如,在至少一种形式中,闩锁系统710包括可动地联接到底座240的锁定构件或锁定轭712。在例示的示例中,例如,锁定轭712为U形,其具有两个隔开并向下延伸的支脚714。支脚714各自具有在其上形成的枢轴耳状物716,这些枢轴耳状物适于被接收在底座240中形成的对应孔245中。这种构造有利于将锁定轭712枢转附接到底座240。锁定轭712可包括两个朝近侧突起的锁定耳状物714,这两个锁定耳状物被构造成能够与框架20的远侧附接凸缘700中对应的锁定棘爪或凹槽704可释放地接合。参见图3。在各种形式中,锁定轭712被弹簧或偏置构件(未示出)沿近侧方向偏置。锁定轭712的致动可通过可滑动地安装在闩锁致动器组件720上的闩锁按钮722来实现,该闩锁致动器组件安装到底座240。闩锁按钮722可相对于锁轭712沿近侧方向偏置。如将在下文进一步详细地讨论,锁轭712可通过沿远侧方向偏置闩锁按钮而移动到解锁位置,这也引起锁轭712枢转,不再与框架20的远侧附接凸缘700保持接合。当锁轭712与框架20的远侧附接凸缘700“保持接合”时,锁耳716保持坐置在远侧附接凸缘700中对应的锁定棘爪或凹槽704内。
当采用包括适于切割和紧固组织的本文所述类型的端部执行器以及其他类型的端部执行器的可互换轴组件时,可能有利的是防止可互换轴组件在端部执行器致动的过程中从外壳不经意地脱离。例如,在使用中,临床医生可致动闭合触发器32以抓持目标组织并将其操纵到期望的位置中。一旦目标组织以期望取向定位在端部执行器300内,临床医生就可完全致动闭合触发器32,以关闭砧座306并将目标组织夹持在合适位置供切割与缝合。在这种情况下,第一驱动系统30已被完全致动。在目标组织已被夹持在端部执行器300中之后,可能有利的是防止轴组件200从外壳12不经意地脱离。闩锁系统710的一种形式被构造成能够防止这种不经意的脱离。
如可在图7中最具体所见,锁定轭712包括至少一个并且优选地两个锁定钩718,该锁定钩能够接触在闭合梭动件250上形成的对应的锁定耳状物部分256。参见图13至图15,当闭合梭动件250处于未致动位置(即,第一驱动系统30未致动并且砧座306打开)时,锁定轭712可沿远侧方向枢转,以将可互换轴组件200从外壳12解锁。当处于该位置时,锁定钩718不接触闭合梭动件250上的锁定耳状物部分256。然而,当闭合梭动件250运动到致动位置(即,第一驱动系统30被致动并且砧座306处于闭合位置)时,锁定轭712被阻止枢转到解锁位置。参见图16-18。换句话讲,如果临床医生试图将锁定轭712枢转到解锁位置,或者例如,锁定轭712以原本可能引起其朝远侧枢转的方式不经意地受到碰撞或发生接触,则锁定轭712上的锁定钩718将接触闭合梭动件250上的锁定耳状物256,并且防止锁定轭712运动到解锁位置。
现在将参照图3来描述可互换轴组件200与柄部组件14的附接。为了开始联接过程,临床医生可将可互换轴组件200的底座240定位在框架20的远侧附接凸缘700上方或与该远侧附接凸缘700相邻,使得底座240上形成的锥形附接部分244与框架20中的燕尾形狭槽702对齐。然后临床医生可沿垂直于轴轴线SA-SA的安装轴线IA移动轴组件200,以使附接部分244坐置成与对应的燕尾形接收狭槽702“可操作地接合”。这样做时,中间击发轴222上的轴附接耳状物226也将坐置在可纵向运动的驱动构件120中的支架126中,并且第二闭合连杆38上的销37的部分将坐置在闭合轭250中的对应钩252中。如本文所用,在具有两个部件的上下文中的术语“可操作地接合”是指该两个部件彼此充分地接合,使得一旦向其施加致动动作,该部件就可以执行其预期活动、功能和/或工序。
如上文所讨论,可互换轴组件200的至少五个系统能够可操作地与柄部组件14的至少五个对应系统联接。第一系统可包括框架系统,该框架系统将轴组件200的框架或脊与柄部组件14的框架20联接和/或对齐。第二系统可包括闭合驱动系统30,该闭合驱动系统可将柄部组件14的闭合触发器32与轴组件200的闭合管260和砧座306可操作地连接。如上文所概述,轴组件200的闭合管附接轭250可与第二闭合连杆38上的销37接合。另一系统可包括击发驱动系统80,该击发驱动系统可将柄部组件14的击发触发器130与轴组件200的中间击发轴222可操作地连接。
如上文所概述,轴附接耳状物226可与纵向驱动构件120的支架126可操作地连接。另一系统可包括电气系统,该电气系统能够:发送轴组件(例如诸如轴组件200)已与柄部组件14可操作地接合的信号到柄部组件14中的控制器(例如诸如微控制器),并且/或者在轴组件200与柄部组件14之间传导功率和/或通信信号。例如,轴组件200可包括可操作地安装到轴电路板610的电连接器1410。电连接器1410被构造用于与柄部控制板100上的对应的电连接器1400配合接合。有关电路系统和控制系统的更多细节可见于美国专利申请序列号13/803,086,该专利申请的完整公开内容此前以引用方式并入本文。第五系统可由用于将轴组件200可释放地锁定到柄部组件14的闩锁系统组成。
再次参见图2和图3,柄部组件14可包括电连接器1400,该电连接器包括多个电触点。现在转到图19,电连接器1400可包括例如第一触点1401a、第二触点1401b、第三触点1401c、第四触点1401d、第五触点1401e和第六触点1401f。尽管所示的示例利用六个触点,但可设想到可利用多于六个触点或少于六个触点的其他示例。
如图19所示,第一触点1401a可与晶体管1408电连通,触点1401b-1401e可与微控制器1500电连通,并且第六触点1401f可与地电连通。在某些情况下,电触点1401b-1401e中的一者或多者可与微控制器1500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,或具有施加到其的电压电位。在一些情况下,电触点1401b-1401e中的一者或多者可与微控制器1500的一个或多个输入通道电连通,并且当柄部组件14处于加电状态时,微控制器1500可被构造成能够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200)装配到柄部组件14时,电触点1401a-1401f可不彼此连通。然而,当轴组件未装配到柄部组件14时,电连接器1400的电触点1401a-1401f可暴露,并且在一些情况下,触点1401a-1401f中的一者或多者可意外地放置成彼此电连通。例如,当触点1401a-1401f中的一者或多者接触导电材料时,可出现此类情况。当发生这种情况时,例如,微控制器1500可接收错误的输入并且/或者轴组件200可接收错误的输出。为解决这个问题,在各种情况下,当轴组件(例如诸如轴组件200)未附接到柄部组件14时,柄部组件14可不加电。
在其他情况下,柄部1042可在轴组件例如诸如轴组件200未附接到柄部1042时加电。在这种情况下,例如,微控制器1500可被构造成能够忽视施加到与微控制器1500电连通的触点(即,触点1401b-1401e)的输入或电压电位,直到轴组件附接到柄部组件14。虽然在这种情况下微控制器1500可被供电以操作柄部组件14的其他功能,但柄部组件14可处于掉电状态。在某种程度上,当施加到电触点1401b-1401e的电压电位可不影响柄部组件14的操作时,电连接器1400可处于掉电状态。读者将会知道,即使触点1401b-1401e可处于掉电状态,但未与微控制器1500电连通的电触点1401a和1401f可处于或可不处于掉电状态。例如,无论柄部组件14处于加电还是掉电状态,第六触点4001f均可保持与地电连通。
此外,无论柄部组件14是处于加电还是掉电状态,晶体管1408和/或晶体管的任何其他合适构造,例如诸如晶体管1410,和/或开关可被构造成能够控制从电源1404例如诸如柄部组件14内的电池90到第一电触点1401a的功率供应。在各种情况下,例如,当轴组件200与柄部组件14接合时,轴组件200可被构造成能够改变晶体管1408的状态。在某些情况下,除下述之外,磁场传感器1402可被构造成能够转换晶体管1410的状态,因此可转换晶体管1408的状态,最终将来自电源1404的功率供应给第一触点1401a。这样,联接到连接器1400的功率电路和信号电路两者当轴组件未安装到柄部组件14时可被掉电,并且当轴组件安装到柄部组件14时可被加电。
在各种情况下,再次参见图19,柄部组件14可包括例如磁场传感器1402,当轴组件联接到柄部组件14时,该磁场传感器可被构造成能够检测位于该轴组件(诸如轴组件200)上的可检测元件,诸如磁性元件1407(图3)。磁场传感器1402可由例如诸如电池之类的电源1406供电,该电源实际上可放大磁场传感器1402的检测信号,并经由图19所示的电路与微控制器1500的输入通道通信。一旦微控制器1500接收到指示轴组件已至少部分地联接到柄部组件14、因而电触点1401a-1401f不再暴露的输入,微控制器1500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1500将对从轴组件传输到一个或多个触点1401b-1401e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1401b-1401e将信号传输到轴组件。在各种情况下,在磁场传感器1402可检测到磁性元件1407之前,可能必须使轴组件200完全坐置。例如,虽然可利用磁场传感器1402来检测轴组件200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装配到柄部组件14。这样,除上述之外,联接到连接器1400的功率电路和信号电路两者当轴组件未安装到柄部组件14时可被掉电,并且当轴组件安装到柄部组件14时可被加电。
在各种示例中,如本公开通篇所用,例如,可采用任何合适的磁场传感器来检测轴组件是否已装配到柄部组件14。例如,用于磁场感测的技术包括霍尔效应传感器、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。
参见图19,微控制器1500通常可包括微处理器(“处理器”)和可操作地联接到处理器的一个或多个存储器单元。处理器通过执行存储器中存储的指令码,可控制外科器械的各种部件,例如诸如马达、各种驱动系统和/或用户显示器。微控制器1500可使用集成的和/或离散的硬件元件、软件元件和/或硬件元件和软件元件两者的组合来实现。集成硬件元件的示例可包括处理器、微处理器、微控制器、集成电路、专用集成电路(ASIC)、可编程逻辑器件(PLD)、数字信号处理器(DSP)、现场可编程门阵列(FPGA)、逻辑门、寄存器、半导体器件、芯片、微芯片、芯片组、微控制器、片上系统(SoC)和/或封装系统(SIP)。离散硬件元件的示例可包括电路和/或电路元件,诸如逻辑门、场效应晶体管、双极型晶体管、电阻器、电容器、电感器和/或继电器。在某些情况下,例如,微控制器1500可包括混合电路,该混合电路在一个或多个基板上包括离散的和集成的电路元件或部件。
参见图19,微控制器1500可例如为可购自Texas Instruments的LM4F230H5QR。在某些情况下,Texas Instruments LM4F230H5QR为ARM Cortex-M4F处理器芯,其包括:256KB的单循环闪速存储器或其他非易失性存储器(最高40MHZ)的片上存储器、用于使性能改善超过40MHz的预取缓冲器、32KB的单循环串行随机访问存储器(SRAM)、装载有软件的内部只读存储器(ROM)、2KB电可擦编程只读存储器(EEPROM)、一个或多个脉宽调制(PWM)模块、一个或多个正交编码器输入(QEI)模拟、具有12个模拟输入通道的一个或多个12位模数转换器(ADC),以及易得的其他特征。可以很方便地换用其他微控制器,来与本公开联合使用。因此,本公开不应限于这一上下文。
如上文所讨论,当轴组件200未装配到或未完全装配到柄部组件14时,柄部组件14和/或轴组件200可包括下述系统和构型:这些系统和构型被构造成能够防止或至少降低柄部电连接器1400的触点和/或轴电连接器1410的触点发生短路的可能性。参见图3,柄部电连接器1400可至少部分地陷入柄部框架20中限定的腔体1409内。电连接器1400的六个触点1401a-1401f可完全陷入腔体1409内。这种构造可降低物体意外地接触触点1401a-1401f中的一者或多者的可能性。相似地,轴电连接器1410可定位在轴底座240中限定的凹陷部内,这可降低物体意外地接触轴电连接器1410的触点1411a-1411f中的一者或多者的可能性。参照图3所示的具体示例,轴触点1411a-1411f可包括凸形触点。在至少一个示例中,例如,每个轴触点1411a-1411f可包括从其延伸的柔性突出部,该柔性突出部可被构造成能够接合对应的柄部触点1401a-1401f。柄部触点1401a-1401f可包括凹形触点。在至少一个示例中,每个柄部触点1401a-1401f可包括例如平坦表面,轴凸形触点1401a-1401f可抵靠该平坦表面擦过或滑过,并且抵靠和维持位于平坦表面和轴凸形触点1401a-1401f之间的导电接口。在各种情况下,将轴组件200装配到柄部14的方向可平行于、或至少基本上平行于柄部触点1401a-1401f,使得在将轴组件200装配到柄部组件14时,轴触点1411a-1411f抵靠柄部触点1401a-1401f滑动。在各种另选示例中,柄部触点1401a-1401f可包括凸形触点,并且轴触点1411a-1411f可包括凹形触点。在某些另选示例中,柄部触点1401a-1401f和轴触点1411a-1411f可具有任何合适的触点构造。
在各种情况下,柄部组件14可包括被构造成能够至少部分地覆盖柄部电连接器1400的连接器防护件和/或被构造成能够至少部分地覆盖轴电连接器1410的连接器防护件。当轴组件未装配到、或只部分地装配到柄部时,连接器防护件可防止、或至少降低物体意外地接触电连接器的触点的可能性。连接器防护件可以是可动的。例如,连接器防护件可在防护位置与非防护位置之间运动,在防护位置,该连接器防护件至少部分地保护连接器,在非防护位置,该连接器防护件不保护连接器,或至少为连接器提供较少保护。在至少一个示例中,当将轴组件装配到柄部时,连接器防护件的位置可被移置。例如,如果柄部包括柄部连接器防护件,则当将轴组件装配到柄部时,轴组件可接触并移置柄部连接器防护件。相似地,如果轴组件包括轴连接器防护件,则在将轴组件装配到柄部时,柄部可接触并移置轴连接器防护件。在各种情况下,例如,连接器防护件可包括门。在至少一种情况下,门可包括倾斜表面,当门与柄部或轴接触时,该倾斜表面可有利于门沿特定方向的位移。在各种情况下,例如,连接器防护件可被平移和/或旋转。在某些情况下,连接器防护件可包括覆盖电连接器触点的至少一层膜。当将轴组件装配到柄部时,这层膜可能破裂。在至少一种情况下,连接器的凸形触点可先刺透这层膜,再与定位在这层膜下方的对应触点接合。
如上所述,外科器械可包括能够选择性地对电连接器(诸如电连接器1400)的触点进行加电或激活的系统。在各种情况下,触点可在未激活状况与激活状况之间转换。在某些情况下,触点可在监控状况、去激活状况与激活状况之间转换。例如,当轴组件尚未装配到柄部14时,微控制器1500例如可监控触点1401a-1401f,以确定触点1401a-1401f中的一者或多者是否可能已经短路。微控制器1500可被构造成能够将低电压电位施加到触点1401a-1401f中的每者,并评估在该触点中的每个处是否仅存在最小电阻。这种操作状态可包括监控状况。如果在某个触点处检测到的电阻很高,或超过了阈值电阻,则微控制器1500可去激活该触点、多于一个触点,或者全部触点。这种操作状态可包括去激活状况。如上文所讨论,如果轴组件装配到柄部组件14,并被微控制器1500检测到,则微控制器1500可提高施加到触点1401a-1401f的电压电位。这种操作状态可包括激活状况。
本文所公开的各种轴组件可采用传感器和各种其他部件,所述传感器和各种其他部件需要与外壳中的控制器电连通。这些轴组件通常被构造成能够相对于外壳旋转,因此必须在两个或更多个可相对彼此旋转的部件之间设置有利于这种电连通的连接件。当采用本文所公开类型的端部执行器时,连接器构造在本质上必须相对稳固,同时还必须略微紧凑,以装配到轴组件的连接器部分中。
参见图20,示出了端部执行器300的非限制性形式。如上所述,端部执行器300可包括砧座306和钉仓304。在该非限制性示例中,砧座306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306延伸的销152并允许砧座306相对于细长通道198和钉仓304从打开位置枢转到闭合位置。此外,图20示出了被构造成能够纵向平移到端部执行器300中的击发杆172。击发杆172可由一个实心部分构成,或在各种示例中,可包括层压材料,该层压材料包括例如一叠钢板。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306处于闭合位置时有助于将砧座306与定位在细长通道198中的钉仓304间隔开。E型横梁178还可包括锋利切割刃182,当通过击发杆172向远侧推进E型横梁178时,切割刃182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304。钉仓304可包括模塑的仓体194,该仓体保持多个钉191,所述多个钉安置在钉驱动器192上,所述钉驱动器位于相应向上打开的钉腔195中。楔形滑动件190通过E形梁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304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306变形接触,同时E形梁178的切割表面182切断夹紧的组织。
除上述之外,E型横梁178可包括在击发期间接合砧座306的上部销180。E型横梁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304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型横梁178可滑动穿过对齐的狭槽193,197和189,如图20所示,其中E型横梁178的底脚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306。在这种情况下,当击发杆172朝远侧运动以从钉仓304击发钉和/或切割捕获在砧座306和钉仓304之间的组织时,E形横梁178可分开或限制砧座306和钉仓304之间的相对运动。然后,击发杆172和E型横梁178可向近侧回缩,从而允许砧座306打开,以释放两个缝合和切割的组织部分(未示出)。
现已概括地描述了外科器械10(图1-4),下面将详细描述外科器械10的各种电力/电子部件。现在转到图21A-21B,其中示出了包括多个电路段2002a-2002g的分段电路2000的一个示例。包括多个电路段2002a-2002g的分段电路2000被构造成能够控制电动外科器械,例如诸如但不限于图1-18A中所示的外科器械10。多个电路段2002a-2002g被构造成能够控制电动外科器械10的一种或多种操作。安全处理器段2002a(第1段)包括安全处理器2004。主处理器段2002b(第2段)包括主处理器2006。安全处理器2004和/或主处理器2006被构造成能够与一个或多个另外的电路段2002c-2002g进行交互,以控制电动外科器械10的操作。主处理器2006包括联接到例如一个或多个电路段2002c-2002g、电池2008和/或多个开关2058a-2070的多个输入装置。分段电路2000可通过任何合适的电路(诸如电动外科器械10内的印刷电路板组件(PCBA))来实施。应当理解,本文使用的术语“处理器”包括任一种微处理器、微控制器,或者将计算机的中央处理单元(CPU)的功能结合到一个集成电路或最多几个集成电路上的其他基础计算装置。处理器是多用途的可编程装置,该装置接收数字数据作为输入,依据其存储器中存储的指令来处理输入,然后提供结果作为输出。处理器是顺序数字逻辑的示例,因为其具有内部存储器。处理器的操作对象是以二进制数字系统表示的数字和符号。
在一个方面,主处理器2006可为任一种单核或多核处理器,诸如已知的由TexasInstruments生产的商品名为ARM Cortex的那些。在一个示例中,安全处理器2004可以是包括两个基于微控制器的系列(诸如TMS570和RM4x)的安全微控制器平台,已知同样由TexasInstruments生产的商品名为Hercules ARM Cortex R4。然而,可不受限制地采用微控制器和安全处理器的其他合适的替代物。在一个示例中,安全处理器2004可具体地针对IEC61508和ISO 26262安全关键应用等等进行构造,以在输送可量化的性能、连通性和存储选项时提供高级集成安全特征。
在某些情况下,主处理器2006可为例如可购自Texas Instruments的LM4F230H5QR。在至少一个示例中,Texas Instruments LM4F230H5QR为ARM Cortex-M4F处理器芯,其包括:256KB的单循环闪速存储器或其他非易失性存储器(最高40MHZ)的片上存储器、用于使性能改善超过40MHz的预取缓冲器、32KB的单循环SRAM、装载有软件的内部ROM、2KB的EEPROM、一个或多个PWM模块、一个或多个QEI模拟、具有12个模拟输入通道的一个或多个12位ADC,以及对于产品数据表而言易得的其他特征。可以很方便地换用其他处理器,因此,本公开不应限于这一上下文。
在一个方面,分段电路2000包括加速度段2002c(第3段)。加速度段2002c包括加速度传感器2022。加速度传感器2022可包括例如加速度计。加速度传感器2022被构造成能够检测电动外科器械10的运动或加速度。在一些示例中,来自加速度传感器2022的输入用于例如转变到休眠模式和从休眠模式转变到其他模式、识别电动外科器械的取向,并且/或者识别外科器械何时已被放下。在一些示例中,加速度段2002c联接到安全处理器2004和/或主处理器2006。
在一个方面,分段电路2000包括显示器段2002d(第4段)。显示器段2002d包括联接到主处理器2006的显示器连接器2024。显示器连接器2024通过一个或多个显示器驱动器集成电路2026将主处理器2006联接到显示器2028。显示器驱动器集成电路2026可与显示器2028集成,和/或可与显示器2028分开定位。显示器2028可包括任一种合适的显示器,诸如有机发光二极管(OLED)显示器、液晶显示器(LCD)和/或其他任何合适的显示器。在一些示例中,显示器段2002d联接到安全处理器2004。
在一些方面,分段电路2000包括轴段2002e(第5段)。轴段2002e包括用于联接到外科器械10的轴2004的一个或多个控件,和/或用于联接到轴2004的端部执行器2006的一个或多个控件。轴段2002e包括轴连接器2030,该轴连接器被构造成能够将主处理器2006联接到轴PCBA 2031。轴PCBA2031包括第一关节运动开关2036、第二关节运动开关2032、和轴PCBA EEPROM 2034。在一些示例中,轴PCBA EEPROM 2034包括特定于轴2004和/或轴PCBA2031的一个或多个参数、例程和/或程序。轴PCBA 2031可联接到轴2004和/或与外科器械10成为一体。在一些示例中,轴段2002e包括第二轴EEPROM 2038。第二轴EEPROM 2038包括与可与电动外科器械10交接的一个或多个轴2004和/或端部执行器2006对应的多个算法、例程、参数、和/或其他数据。
在一些方面,分段电路2000包括位置编码器段2002f(第6段)。位置编码器段2002f包括一个或多个磁性旋转位置编码器2040a-2040b。一个或多个磁性旋转位置编码器2040a-2040b被构造成能够识别外科器械10的马达2048、轴2004和/或端部执行器2006的旋转位置。在一些示例中,磁性旋转位置编码器2040a-2040b可联接到安全处理器2004和/或主处理器2006。
在一些方面,分段电路2000包括马达段2002g(第7段)。马达段2002g包括马达2048,该马达被构造成能够控制电动外科器械10的一种或多种运动。马达2048通过H桥驱动器2042和一个或多个H桥场效应晶体管(FET)2044联接到主处理器2006。H桥FET 2044联接到安全处理器2004。马达电流传感器2046与马达2048串联联接,用于测量马达2048的电流消耗。马达电流传感器2046与主处理器2006和/或安全处理器2004进行信号通信。在一些示例中,马达2048联接到马达电磁干扰(EMI)滤波器2050。
在一些方面,分段电路2000包括功率段2002f(第8段)。电池2008联接到安全处理器2004、主处理器2006,以及另外的电路段2002c-2002g中的一者或多者。电池2008通过电池连接器2010和电流传感器2012联接到分段电路2000。电流传感器2012被构造成能够测量分段电路2000的总电流消耗。在一些示例中,一个或多个电压转换器2014a、2014b、2016被构造成能够向一个或多个电路段2002a-2002g提供预先确定的电压值。例如,在一些示例中,分段电路2000可包括3.3V的电压转换器2014a-2014b和/或5V的电压转换器2016。升压转换器2018被构造成能够提供最高为预先确定的量(诸如,最高13V)的升压电压。升压转换器2018被构造成能够在功率密集操作期间提供附加的电压和/或电流,并且能够防止电压降低状况或低功率状况。
在一些方面,安全段2002a包括马达功率中断2020。马达功率中断2020联接在功率段2002h与马达段2002g之间。安全段2002a被构造成能够在安全处理器2004和/或主处理器2006检测到错误或故障状况时中断到马达段2002g的功率,如本文更详细地讨论。尽管电路段2002a-2002g被示为具有电路段2002a-2002h中物理位置接近的所有部件,但本领域的技术人员将认识到,电路段2002a-2002h可包括在物理上和/或在电学上与相同电路段2002a-2002g的部件分开的其他部件。在一些示例中,一个或多个部件可由两个或更多个电路段2002a-2002g共享。
在一些方面,多个开关2056-2070联接到安全处理器2004和/或主处理器2006。多个开关2056-2070可被构造成能够控制外科器械10的一种或多种操作、能够控制分段电路2000的一种或多种操作,和/或能够指示外科器械10的状态。例如,应急门开关2056被构造成能够指示应急门的状态。多个关节运动开关(诸如左侧向左关节运动开关2058a、左侧向右关节运动开关2060a、左侧向中心关节运动开关2062a、右侧向左关节运动开关2058b、右侧向右关节运动开关2060b和右侧向中心关节运动开关2062b)被构造成能够控制轴2004和/或端部执行器2006的关节运动。左侧换向开关2064a和右侧换向开关2064b联接到主处理器2006。在一些示例中,左侧开关(包括左侧向左关节运动开关2058a、左侧向右关节运动开关2060a、左侧向中心关节运动开关2062a和左侧换向开关2064a)通过左挠性连接器2072a联接到主处理器2006。右侧开关(包括右侧向左关节运动开关2058b、右侧向右关节运动开关2060b、右侧向中心关节运动开关2062b和右侧换向开关2064b)通过右挠性连接器2072b联接到主处理器2006。在一些示例中,击发开关2066、夹持释放开关2068和轴接合开关2070联接到主处理器2006。
在一些方面,多个开关2056-2070可包括例如安装到外科器械10的柄部的多个柄部控件、多个指示器开关、和/或它们的任何组合。在各种示例中,多个开关2056-2070允许外科医生操纵外科器械,向分段电路2000提供有关外科器械的位置和/或操作的反馈,和/或指示外科器械10的不安全操作。在一些示例中,另外的或较少的开关可联接到分段电路2000,开关2056-2070中的一个或多个可组合成单个开关,和/或扩展成多个开关。例如,在一个示例中,左侧关节运动开关和/或右侧关节运动开关2058a-2064b中的一者或多者可组合成单个多位置开关。
在一个方面,安全处理器2004被构造成能够除了其他的安全操作以外实现看门狗功能。分段电路2000的安全处理器2004和主处理器2006进行信号通信。微处理器活心跳信号在输出端2096处提供。加速度段2002c包括加速度计2022,该加速度计被构造成能够监控外科器械10的运动。在各种示例中,加速度计2022可为单轴、双轴或三轴加速度计。加速度计2022可用于测量适当的加速度,该加速度不一定为坐标加速度(速度改变的速率)。作为替代,加速度计观察到在加速度计2022的参照系静止时,与测试质量经受的重量现象相关联的加速度。例如,在地球的表面上静止的加速度计2022由于其重量将测量竖直向上的(重力)加速度g=9.8m/s2。加速度计2022可测量的另一类加速度是重力加速度。在各种其他示例中,加速度计2022可包括单轴、双轴或三轴加速度计。此外,加速度段2002c可包括一个或多个惯性传感器,以检测和测量加速度、倾斜、冲击、振动、旋转和多自由度(DoF)。合适的惯性传感器可包括加速度计(单轴、双轴或三轴)、用于测量空间磁场(诸如地球磁场)的磁力计和/或用于测量角速度的陀螺仪。
在一个方面,安全处理器2004被构造成能够针对一个或多个电路段2002c-2002h例如诸如马达段2002g实现看门狗功能。就这一点来说,安全处理器2004采用看门狗功能来检测主处理器2006的故障并从主处理器2006的故障中恢复。在正常操作期间,安全处理器2004监控主处理器2004的硬件故障或程序错误,并发起一种或多种纠正行动。纠正行动可包括将主处理器2006置于安全状态,并恢复正常的系统操作。在一个示例中,安全处理器2004至少联接到第一传感器。第一传感器测量外科器械10(图1-4)的第一性质。在一些示例中,安全处理器2004被构造成能够将外科器械10的所测量性质与预先确定的值进行比较。例如,在一个示例中,马达传感器2040a联接到安全处理器2004。马达传感器2040a向安全处理器2004提供马达的速度和位置信息。安全处理器2004监控马达传感器2040a并将值与最大速度和/或位置值进行比较,并且如果值高于预先确定的值,则阻止马达2048的操作。在一些示例中,预先确定的值基于马达2048的实时速度和/或位置计算、由与主处理器2006连通的第二马达传感器2040b提供的值计算,并且/或者从例如联接到安全处理器2004的存储器模块提供给安全处理器2004。
在一些方面,第二传感器联接到主处理器2006。第二传感器被构造成能够测量第一物理性质。安全处理器2004和主处理器2006被构造成能够提供分别指示第一传感器的值和第二传感器的值的信号。当安全处理器2004或主处理器2006指示超出可接受范围的值时,分段电路2000便阻止电路段2002c-2002h中至少一者例如诸如马达段2002g的操作。例如,在图21A-21B所示的示例中,安全处理器2004联接到第一马达位置传感器2040a,并且主处理器2006联接到第二马达位置传感器2040b。马达位置传感器2040a,2040b可包括任何合适的马达位置传感器,例如诸如具有正弦和余弦输出的磁性角度旋转输入装置。马达位置传感器2040a,2040b向安全处理器2004和主处理器2006提供指示马达2048的位置的相应的信号。
当第一马达传感器2040a的值和第二马达传感器2040b的值处于预先确定的范围内时,安全处理器2004和主处理器2006生成激活信号。当主处理器2006或安全处理器2004检测到值超出预先确定的范围时,则终止激活信号,随即中断和/或阻止至少一个电路段2002c-2002h例如诸如马达段2002g的操作。例如,在一些示例中,来自主处理器2006的激活信号和来自安全处理器2004的激活信号耦合到与门。与门联接到马达功率开关2020。当来自安全处理器2004和主处理器2006这两者的激活信号都较高(指示马达传感器2040a,2040b的值在预先确定的范围内)时,与门便将马达功率开关2020保持在闭合或打开位置。当马达传感器2040a,2040b中任一者检测到值超出预先确定的范围时,则来自马达传感器2040a,2040b的激活信号被设定为低,并且与门的输出也被设定为低,从而断开马达功率开关2020。在一些示例中,第一传感器2040a的值与第二传感器2040b的值例如通过安全处理器2004和/或主处理器2006进行比较。当第一传感器的值与第二传感器的值不同时,安全处理器2004和/或主处理器2006便可阻止马达段2002g的操作。
在一些方面,安全处理器2004接收指示第二传感器2040b的值的信号,并且将第二传感器的值与第一传感器的值进行比较。例如,在一个方面,安全处理器2004直接联接到第一马达传感器2040a。第二马达传感器2040b联接到主处理器2006,该主处理器将第二马达传感器2040b的值提供给安全处理器2004,和/或直接联接到安全处理器2004。安全处理器2004将第一马达传感器2040的值与第二马达传感器2040b的值进行比较。当安全处理器2004检测到第一马达传感器2040a与第二马达传感器2040b之间存在失配时,安全处理器2004可例如通过切断到马达段2002g的功率来中断马达段2002g的操作。
在一些方面,安全处理器2004和/或主处理器2006联接到被构造成能够测量外科器械的第一性质的第一传感器2040a和被构造成能够测量外科器械的第二性质的第二传感器2040b。第一性质和第二性质包括外科器械正常操作时的预先确定的关系。安全处理器2004监控第一性质和第二性质。当检测到第一性质的值和/或第二性质的值与预先确定的关系不一致时,则发生故障。发生故障时,安全处理器2004至少采取一种行动,诸如,阻止电路段中的至少一者的操作、执行预先确定的操作,和/或重置主处理器2006。例如,安全处理器2004在检测到故障时可断开马达功率开关2020,以切断到马达电路段2002g的功率。
在一个方面,安全处理器2004被构造成能够执行独立的控制算法。在操作中,安全处理器2004监控分段电路2000并且被构造成能够独立地控制和/或覆写来自其他电路部件诸如主处理器2006的信号。安全处理器2004可执行预先编程的算法并且/或者在操作期间可基于外科器械10的一种或多种行动和/或位置进行联机更新或联机编程。例如,在一个示例中,每当新的轴和/或端部执行器联接到外科器械10时,便使用新的参数和/或安全算法对安全处理器2004进行重新编程。在一些示例中,安全处理器2004存储的一个或多个安全值由主处理器2006复制。执行双向错误检测,以确保处理器2004或2006存储的值和/或参数是正确的。
在一些方面,安全处理器2004和主处理器2006实施冗余的安全检查。安全处理器2004和主处理器2006提供周期性信号,用于指示操作正常。例如,在操作期间,安全处理器2004可向主处理器2006指示安全处理器2004正在执行代码并且操作正常。主处理器2006同样可向安全处理器2004指示主处理器2006正在执行代码并且操作正常。在一些示例中,安全处理器2004和主处理器2006以预先确定的间隔连通。预先确定的间隔可为常数,或可基于电路状态和/或外科器械10的操作而改变。
图22示出了功率组件2100的一个示例,该功率组件包括被构造成能够监控功率组件2100的使用循环计数的使用循环电路2102。功率组件2100可联接到外科器械2110。使用循环电路2102包括处理器2104和使用指示器2106。使用指示器2106被构造成能够向处理器2104提供信号,以指示电池组2100和/或联接到功率组件2100的外科器械2110的使用情况。“使用情况”可包括任何合适的动作、条件和/或参数,例如,改变外科器械2110的模块化部件、部署或击发联接到外科器械2110的一次性部件、从外科器械2110递送电外科能量、修复外科器械2110和/或功率组件2100、交换功率组件2100、为功率组件2100再充电,和/或超出外科器械2110和/或电池组2100的安全限制。
在一些情况下,使用循环或使用情况由一个或多个功率组件2100参数限定。例如,在一种情况下,当功率组件2100处于完全充电水平时,使用循环包括使用大于5%的可来自功率组件2100的总能量。在另一种情况下,使用循环包括超出预先确定的时间限值的从功率组件2100的连续能量消耗。例如,使用循环可对应于从功率组件2100连续和/或总能量消耗五分钟。在一些情况下,功率组件2100包括使用循环电路2102,该使用循环电路存在连续功率消耗,以将使用循环电路2102的一个或多个部件例如使用指示器2106和/或计数器2108保持在启用状态下。
处理器2104保持着使用循环计数。使用循环计数指示出由使用指示器2106检测到的功率组件2100和/或外科器械2110的使用次数。处理器2104可根据来自使用指示器2106的输入而增加和/或减少使用循环计数。使用循环计数用于控制功率组件2100和/或外科器械2110的一个或多个操作。例如,在一些情况下,当使用循环计数超出预先确定的使用限度时,停用功率组件2100。尽管本文所述情况是相对于增加使用循环计数使其超出预先确定的使用限度而论述的,但本领域中的那些技术人员将认识到,使用循环计数可开始于某个预先确定的量,并可由处理器2104减少。在这种情况下,当使用循环计数降至低于预先确定的使用限度时,处理器2104即启动和/或阻止功率组件2100的一个或多个操作。
使用循环计数由计数器2108保持。计数器2108包括任何合适的电路,例如,存储器模块、模拟计数器和/或被构造成能够保持使用循环计数的任何电路。在一些情况下,计数器2108与处理器2104一体地形成。在其他情况下,计数器2108包括单独的部件,例如固态存储器模块。在一些情况下,使用循环计数被提供给远程系统,例如中央数据库。使用循环计数由通信模块2112传输到远程系统。通信模块2112被构造成能够使用任何合适的通信媒介,例如,有线和/或无线通信。在一些情况下,通信模块2112被构造成能够在使用循环计数超出预先确定的使用限度时,接收来自远程系统的一个或多个指令,例如控制信号。
在一些情况下,使用指示器2106被构造成能够监控与联接到功率组件2100的外科器械2110一起使用的模块化部件的数目。模块化部件可包括例如模块化轴、模块化端部执行器、和/或任何其他模块化部件。在一些情况下,使用指示器2106监控一个或多个一次性部件的使用情况,例如,在联接到外科器械2110的端部执行器内插入和/或部署钉仓的情况。使用指示器2106包括一个或多个传感器,这些传感器用于检测外科器械2110的一个或多个模块化和/或一次性部件的交换。
在一些情况下,使用指示器2106被构造成能够监控在已安装功率组件2100时进行的单次患者外科手术。例如,当功率组件2100联接到外科器械2110时,使用指示器2106可被构造成能够监控外科器械2110的击发。击发可对应于钉仓的部署、电外科能量的施加和/或任何其他合适的外科事件。使用指示器2106可包括用于在已安装功率组件2100时测量击发次数的一个或多个电路。当进行单次患者手术时,使用指示器2106向处理器2104提供信号,然后处理器2104增加使用循环计数。
在一些情况下,使用指示器2106包括被构造成能够监控电源2114的一个或多个参数(例如,自电源2114消耗的电流)的电路。电源2114的一个或多个参数与可由外科器械2110执行的一个或多个操作相对应,例如,切割和缝合操作。使用指示器2106向处理器2104提供一个或多个参数,当这一个或多个参数指示出手术已进行时,该处理器增加使用循环计数。
在一些情况下,使用指示器2106包括被构造成能够在预先确定的时间段后增加使用循环计数的计时电路。预先确定的时间段对应于单次患者手术时间,即操作者进行手术(例如,切割和缝合手术)所需的时间。当功率组件2100联接到外科器械2110时,处理器2104轮询使用指示器2106,以确定单次患者手术时间是否已结束。当预先确定的时间段已经过去时,处理器2104增加使用循环计数。在增加使用循环计数之后,处理器2104重置用户指示器2106的计时电路。
在一些情况下,使用指示器2106包括与单次患者手术时间近似的时间常数。在一个示例中,使用循环电路2102包括电阻器-电容器(RC)计时电路2506。RC计时电路包括由电阻器-电容器对限定的时间常数。时间常数由电阻器和电容器的值限定。在一个示例中,使用循环电路2552包括可再充电电池和时钟。当功率组件2100安装在外科器械中时,可再充电电池由电源充电。可充电电池包括足够的电力以使时钟运行至少单次患者手术时间。时钟可包括实时时钟、被构造成能够实现计时功能的处理器或任何其他合适的计时电路。
仍参见图22,在一些情况下,使用指示器2106包括传感器,该传感器被构造成能够监控功率组件2100所经受的一种或多种环境条件。例如,使用指示器2106可包括加速度计。加速度计被构造成能够监控功率组件2100的加速度。功率组件2100具有最大加速度耐受度。加速度超过预先确定的阈值表示例如功率组件2100已被放下。当使用指示器2106检测到加速度超过最大加速度耐受度时,处理器2104增加使用循环计数。在一些情况下,使用指示器2106包括水分传感器。水分传感器被构造成能够在功率组件2100已暴露于水分时进行指示。水分传感器可包括例如被构造成能够指示功率组件2100何时已完全浸入清洁流体中的浸没传感器、被构造成能够指示使用期间水分何时接触功率组件2100的水分传感器、和/或任何其他合适的水分传感器。
在一些情况下,使用指示器2106包括化学品接触传感器。化学品接触传感器被构造成能够在功率组件2100已经与有害和/或危险化学品接触时进行指示。例如,在消毒期间,可能使用了导致功率组件2100劣化的不适用的化学品。当使用指示器2106检测到不适用的化学品时,处理器2104增加使用循环计数。
在一些情况下,使用循环电路2102被构造成能够监控功率组件2100所历经的修复循环次数。修复循环可包括例如清洁循环、消毒循环、充电循环、常规和/或预防维修、和/或任何其他合适的修复循环。使用指示器2106被构造成能够检测修复循环。例如,使用指示器2106可包括水分传感器以检测清洁和/或消毒循环。在一些情况下,使用循环电路2102监控功率组件2100所历经的修复循环次数,并在修复循环次数超出预先确定的阈值之后,停用功率组件2100。
使用循环电路2102可被构造成能够监控功率组件2100交换的次数。每当交换功率组件2100时,使用循环电路2102就增加使用循环计数。当超出最大交换次数时,使用循环电路2102锁定功率组件2100和/或外科器械2110。在一些情况下,当功率组件2100联接到外科器械2110时,使用循环电路2102识别功率组件2100的序列号并锁定功率组件2100,使得功率组件2100只能与外科器械2110一起使用。在一些情况下,每当功率组件2100从外科器械2110移除和/或联接到该外科器械时,使用循环电路2102增加使用循环。
在一些情况下,使用循环计数与功率组件2100的消毒相对应。使用指示器2106包括被构造成能够检测消毒循环的一个或多个参数(例如,温度参数、化学参数、水分参数和/或任何其他合适的参数)的传感器。当检测到消毒参数时,处理器2104增加使用循环计数。在预先确定的消毒次数之后,使用循环电路2102停用功率组件2100。在一些情况下,使用循环电路2102在消毒循环、电压传感器和/或任何合适的传感器检测再充电循环期间被重置。当检测到修复循环时,处理器2104增加使用循环计数。当检测到消毒循环时,停用使用循环电路2102。当功率组件2100联接到外科器械2110时,重新激活和/或重置使用循环电路2102。在一些情况下,使用指示器包括零功率指示器。零功率指示器在消毒循环期间改变状态,并当功率组件2100联接到外科器械2110时由处理器2104检查。当零功率指示器指示已经发生消毒循环时,处理器2104增加使用循环计数。
计数器2108保持着使用循环计数。在一些情况下,计数器2108包括非易失性存储器模块。每当检测到使用循环时,处理器2104就增加存储在非易失性存储器模块中的使用循环计数。存储器模块可由处理器2104和/或控制电路(例如,控制电路200)访问。当使用循环计数超出预先确定的阈值时,处理器2104停用功率组件2100。在一些情况下,使用循环计数由多个电路部件保持。例如,在一种情况下,计数器2108包括电阻器(或熔断器)组。在每次使用功率组件2100之后,电阻器(或熔断器)可被烧断成打开位置,从而改变电阻器组的电阻。功率组件2100和/或外科器械2110读取剩余的电阻值。当电阻器组的最后一个电阻器被烧坏时,电阻器组便具有预先确定的电阻(例如,与开式电路相对应的无穷大电阻),这表明功率组件2100已经达到其使用限度。在一些情况下,电阻器组的电阻用于推导出剩余的使用次数。
在一些情况下,当使用循环计数超出预先确定的使用限度时,使用循环电路2102便阻止功率组件2100和/或外科器械2110的进一步使用。在一种情况下,例如,利用与外科器械2110一体形成的屏幕将与功率组件2100相关的使用循环计数提供给操作者。外科器械2110向操作者提供使用循环计数已经超出功率组件2100的预先确定的限值的指示,并阻止外科器械2110的进一步操作。
在一些情况下,使用循环电路2102被构造成能够当达到预先确定的使用限度时在物理上防止其操作。例如,功率组件2100可包括护罩,该护罩被构造成能够在使用循环计数超出预先确定的使用限度时部署在功率组件2100的触点上。该护罩通过覆盖功率组件2100的电连接件阻止功率组件2100的再充电及使用。
在一些情况下,使用循环电路2102至少部分地位于外科器械2110内,并被构造成能够保持外科器械2110的使用循环计数。图22以虚线示出了外科器械2110内的使用循环电路2102的一个或多个部件,并示出使用循环电路2102的替代定位。当超出外科器械2110的预先确定的使用限度时,使用循环电路2102停用和/或阻止外科器械2110的操作。当使用指示器2106检测到特定事件和/或需求(例如,外科器械2110的击发、与单次患者手术时间对应的预先确定的时间段)时,使用循环电路2102响应于表明达到了一个或多个预先确定的阈值和/或满足了任何其他合适需求的系统诊断,而根据外科器械2110的一个或多个马达参数递增使用循环计数。如上文所讨论,在一些情况下,使用指示器2106包括与单次患者手术时间相对应的计时电路。在其他情况下,使用指示器2106包括一个或多个传感器,这些传感器被构造成能够检测外科器械2110的特定事件和/或条件。
在一些情况下,使用循环电路2102被构造成能够防止在达到预先确定的使用限度之后操作外科器械2110。在一些情况下,外科器械2110包括可视指示器,以便当已经达到和/或超过预先确定的使用限度时给出指示。例如,标记(诸如红色标记)可从外科器械2110(诸如从柄部)弹出,从而为操作者提供外科器械2110已超出预先确定的使用限度的视觉指示。又如,使用循环电路2102可联接到与外科器械2110一体地形成的显示器。使用循环电路2102显示出指示已经超出预先确定的使用限度的消息。外科器械2110可以向操作者提供已经超出预先确定的使用限度的听觉指示。例如,在一种情况下,当超出预先确定的使用限度时,外科器械2110发出可以听见的音调,然后将功率组件2100从外科器械2110移除。可听见的音调指示出外科器械2110的最后一次使用,并指示应该丢弃或修复外科器械2110。
在一些情况下,使用循环电路2102被构造成能够将外科器械2110的使用循环计数传输到远程位置,例如,中央数据库。使用循环电路2102包括被构造成能够将使用循环计数传输到远程位置的通信模块2112。通信模块2112可利用任何合适的通信系统,例如有线和/或无线通信系统。远程位置可包括被构造成能够保持使用信息的中央数据库。在一些情况下,当功率组件2100联接到外科器械2110时,功率组件2100记录外科器械2110的序列号。例如,当功率组件2100联接到充电器时,该序列号被传输到中央数据库。在一些情况下,中央数据库保持着与外科器械2110的每一次使用相对应的计数。例如,每次使用外科器械2110时,与外科器械2110相关联的条形码就可被扫描。当使用计数超过预先确定的使用限度时,中央数据库向外科器械2110提供指示应该丢弃外科器械2110的信号。
外科器械2110可被构造成能够当使用循环计数超出预先确定的使用限度时锁定和/或阻止操作外科器械2110。在一些情况下,外科器械2110包括一次性仪器,并且在使用循环计数超出预先确定的使用限度之后被丢弃。在其他情况下,外科器械2110包括可重复使用的外科器械,该外科器械可在使用循环计数超出预先确定的使用限度之后被修复。在达到预先确定的使用限度之后,外科器械2110引发可逆闭锁。技术人员例如利用被构造成能够重置使用循环电路2102的专业技术键来修复外科器械2110并释放闭锁。
在一些方面,分段电路2000被构造成能够顺序地启动。先由每个电路段2002a-2002g执行错误检查,再对顺序的下一个电路段2002a-2002g通电。图23示出了用于对分段电路2270例如分段电路2000顺序地通电的过程的一个示例。当电池2008联接到分段电路2000时,安全处理器2004得到供电(步骤2272)。安全处理器2004执行错误自检(步骤2274)。当检测到错误时(步骤2276a),安全处理器停止对分段电路2000供电并生成错误代码(步骤2278a)。当未检测到错误时(步骤2276b),安全处理器2004开始对主处理器2006加电(步骤2278b)。主处理器2006执行错误自检。当未检测到错误时,主处理器2006开始对剩余的电路段中的每个电路段顺序地加电(步骤2278b)。主处理器2006对每个电路段进行通电及错误检查。当未检测到错误时,对下一个电路段通电(步骤2278b)。当检测到错误时,安全处理器2004和/或主处理器停止对电流段通电,并生成错误2278a。继续顺序地启动,直到电路段2002a-2002g已全部通电为止。在一些示例中,分段电路2000在相似的顺序加电过程11250之后从睡眠模式进行转变。
图24示出了包括多个菊花链式功率转换器2314、2316、2318的功率段2302的一个方面。功率段2302包括电池2308。电池2308被构造成能够提供源电压,诸如12V的电压。电流传感器2312联接到电池2308,以监控分段电路和/或一个或多个电路段的电流消耗。电流传感器2312联接到FET开关2313。电池2308联接到一个或多个电压转换器2309、2314、2316。始终接通的转换器2309向一个或多个电路部件例如运动传感器2322提供恒定的电压。始终接通的转换器2309包括例如3.3V转换器。始终接通的转换器2309可向附加电路部件例如安全处理器(未示出)提供恒定的电压。电池2308联接到升压转换器2318。升压转换器2318被构造成能够提供大于由电池2308所提供电压的升压电压。例如,在所示示例中,电池2308提供12V的电压。升压转换器2318被构造成能够将电压升高到13V。升压转换器2318被构造成能够在外科器械(例如,外科器械10(图1-4))的操作期间维持最小的电压。马达的操作可引起提供给主处理器2306的功率降到低于最小阈值,并且在主处理器2306中产生电压降低或重置状况。升压转换器2318确保在外科器械10的操作期间有足够的功率可用于主处理器2306和/或其他电路部件,诸如马达控制器2343。在一些示例中,升压转换器2318直接联接到一个或多个电路部件,诸如OLED显示器2388。
升压转换器2318联接到一个或多个降压转换器,以提供低于升压电压水平的电压。第一电压转换器2316联接到升压转换器2318,并且向一个或多个电路部件提供降低的电压。在所示示例中,第一电压转换器2316提供5V的电压。第一电压转换器2316联接到旋转位置编码器2340。FET开关2317联接在第一电压转换器2316和旋转位置编码器2340之间。FET开关2317由处理器2306来控制。处理器2306例如在功率密集操作期间断开FET开关2317,以去激活位置编码器2340。第一电压转换器2316联接到第二电压转换器2314,该第二降压转换器被构造成能够提供第二降低的电压。第二降低的电压包括例如3.3V的电压。第二电压转换器2314联接到处理器2306。在一些示例中,升压转换器2318、第一电压转换器2316和第二电压转换器2314以菊花链式构型联接。菊花链式构型允许使用更小且更高效的转换器以用于产生低于该升压电压水平的电压水平。然而,这些示例不限于本说明书的上下文中所述的特定电压范围。
图25示出了分段电路2400的一个方面,该分段电路被构造成能够使可用于关键功能和/或功率密集功能的功率最大化。分段电路2400包括电池2408。电池2408被构造成能够提供源电压,例如12V的电压。源电压被提供给多个电压转换器2409、2418。始终接通的电压转换器2409向一个或多个电路部件例如运动传感器2422和安全处理器2404提供恒定的电压。始终接通的电压转换器2409直接联接到电池2408。始终接通的电压转换器2409提供例如3.3V的电压。然而,这些示例不限于本说明书的上下文中所述的特定电压范围。
分段电路2400包括升压转换器2418。升压转换器2418提供大于由电池2408所提供源电压(例如13V)的升压电压。升压转换器2418直接向一个或多个电路部件例如OLED显示器2488和马达控制器2443提供升压电压。通过将OLED显示器2488直接联接到升压转换器2418,分段电路2400消除了专门用于OLED显示器2488的功率转换器的需要。升压转换器2418在马达2448的一个或多个功率密集操作例如切割操作期间向马达控制器2443和马达2448提供升压电压。升压转换器2418联接到降压转换器2416。降压转换器2416被构造成能够将低于所述升压电压的电压(例如5V)提供给一个或多个电路部件。降压转换器2416联接到例如FET开关2451和位置编码器2440。FET开关2451联接到主处理器2406。当分段电路2400转变到休眠模式时,并且/或者在需要将额外的电压传送给马达2448的功率密集功能期间,主处理器2406断开FET开关2451。断开FET开关2451以去激活位置编码器2440,并且消除了位置编码器2440的功率消耗。然而,这些示例不限于本说明书的上下文中所述的特定电压范围。
降压转换器2416联接到线性转换器2414。线性转换器2414被构造成能够提供例如3.3V的电压。线性转换器2414联接到主处理器2406。线性转换器2414向主处理器2406提供操作电压。线性转换器2414可联接到一个或多个额外的电路部件。然而,这些示例不限于本说明书的上下文中所述的特定电压范围。
分段电路2400包括应急开关2456。应急开关2456联接到外科器械10上的应急门。应急开关2456和安全处理器2404联接到与门2419。与门2419向FET开关2413提供输入。当应急开关2456检测到应急状况时,应急开关2456向与门2419提供应急关闭信号。当安全处理器2404检测到例如由于传感器失配而引起的不安全状况时,安全处理器2404向与门2419提供关闭信号。在一些示例中,应急关闭信号和关闭信号两者在正常操作期间都较高,并且当检测到应急状况或不安全的状况时都较低。当与门2419的输出较低时,FET开关2413是断开的,并且马达2448的操作受到阻止。在一些示例中,安全处理器2404利用关闭信号将马达2448转变到休眠模式下的关闭状态。由联接到电池2408的电流传感器2412向FET开关2413提供第三输入。电流传感器2412监视由电路2400消耗的电流,并且当检测到电流大于预先确定的阈值时,断开FET开关2413从而关闭马达2448的电源。FET开关2413和马达控制器2443联接到被构造成能够控制马达2448的操作的一组FET开关2445。
马达电流传感器2446与马达2448串联联接,从而向电流监视器2447提供马达电流传感器读数。电流监视器2447联接到主处理器2406。电流监视器2447提供了指示马达2448电流消耗的信号。主处理器2406可利用来自马达电流监视器2447的信号来控制马达的操作,例如,以确保马达2448的电流消耗位于可接受范围内、将马达2448的电流消耗与电路2400(诸如位置编码器2440)的一个或多个其他参数进行比较、和/或确定治疗部位的一个或多个参数。在一些示例中,电流监视器2447可联接到安全处理器2404。
在一些方面,一个或多个柄部控件例如击发触发器的致动引起主处理器2406在柄部控件被致动时降低供给一个或多个部件的功率。例如,在一个示例中,击发触发器控制切割构件的击发行程。切割构件由马达2448驱动。击发触发器的致动引起马达2448的向前操作和切割构件的推进。在击发期间,主处理器2406闭合FET开关2451,以从位置编码器2440移除功率。一个或多个电路部件的去激活允许更高的功率传送至马达2448。当击发触发器被释放时,例如,通过闭合FET开关2451并且再激活位置编码器2440,全功率恢复至去激活的部件。
在一些方面,安全处理器2404控制分段电路2400的操作。例如,安全处理器2404可启动分段电路2400的顺序加电、分段电路2400进入和退出睡眠模式的转变,和/或可覆写来自主处理器2406的一个或多个控制信号。例如,在所示示例中,安全处理器2404联接到降压转换器2416。安全处理器2404通过激活或去激活降压转换器2416来控制分段电路2400的操作,以向分段电路2400的其余部分提供功率。
图26示出了功率系统2500的一个方面,该功率系统包括被构造成能够被顺序通电的多个菊花链式功率转换器2514、2516、2518。该多个菊花链式功率转换器2514、2516、2518可在初始加电和/或转变自休眠模式期间被例如安全处理器顺序地激活。安全处理器可由独立的功率转换器(未示出)供电。例如,在一个示例中,当电池电压VBATT联接到功率系统2500并且/或者加速度计检测到睡眠模式下的运动时,安全处理器引发菊花链式功率转换器2514、2516、2518的顺序启动。安全处理器激活13V升压段2518。升压段2518通电并执行自检。在一些示例中,升压段2518包括集成电路2520,该集成电路被构造成能够升高源电压并执行自检。二极管D阻止5V供电段2516加电,直到升压段2518已完成自检并已向二极管D提供了指示升压段2518未识别到任何错误的信号为止。在一些示例中,由安全处理器提供该信号。然而,这些示例不限于本说明书的上下文中所述的特定电压范围。
5V供电段2516被顺序地在升压段2518之后加电。5V供电段2516在加电期间执行自检,以识别5V供电段2516中的任何错误。5V供电段2516包括集成电路2515,该集成电路被构造成能够从升压电压提供降低电压,并能够执行错误检查。当未检测到错误时,5V供电段2516完成顺序加电,并向3.3V供电段2514提供激活信号。在一些示例中,安全处理器向3.3V供电段2514提供激活信号。3.3V供电段包括集成电路2513,该集成电路被构造成能够由5V供电段2516提供降低电压,并能够在加电期间执行错误自检。当在自检期间未检测到错误时,3.3V供电段2514向主处理器提供功率。主处理器被构造成能够顺序地对剩余的电路段中的每个电路段供电。通过顺序地对功率系统2500和/或分段电路的剩余部分通电,功率系统2500降低了错误风险,在施加负荷之前实现电压水平的稳定性,并防止所有硬件以不可控的方式同时被接通而产生较大的电流消耗。然而,这些示例不限于本说明书的上下文中所述的特定电压范围。
在一个方面,功率系统2500包括过压识别和消减电路。过压识别及消减电路被构造成能够检测外科器械中的单极返回电流,并且在检测到单极返回电流时中断来自功率段的功率。过压识别及消减电路被构造成能够识别功率系统的地电浮动。过压识别及消减电路包括金属氧化物变阻器。过压识别及消减电路至少包括一个瞬时电压抑制二极管。
图27示出了包括单点控制节段2602的分段电路2600的一个方面。单点控制节段2602使分段电路2600的控制硬件与分段电路2600的功率段(未示出)隔离。控制段2602包括例如主处理器2606、安全处理器(未示出)、和/或附加的控制硬件(例如FET开关2617)。功率段包括例如马达、马达驱动器和/或多个马达MOSFET。单点控制节段2602包括充电电路2603和联接到5V功率转换器2616的可再充电电池2608。充电电路2603和可再充电电池2608使主处理器2606与功率段隔离。在一些示例中,可再充电电池2608联接到安全处理器和任一附加的支持硬件。使控制段2602与功率段隔离允许控制段2602(例如主处理器2606)保持活动的(甚至当主电源被移除时)、穿过可再充电电池2608提供过滤器以保持噪声远离控制段2602、使控制段2602与电池电压中的剧烈变化隔离以确保适当的操作(甚至在较大的马达负载期间)、并且/或者允许实时操作系统(RTOS)被分段电路2600使用。在一些示例中,可再充电电池2608向主处理器提供降低电压,例如,3.3V的电压。然而,这些示例不限于本说明书的上下文中所述的特定电压范围。
图28A和图28B示出了被构造成能够控制图1-18A所示的电动外科器械10的控制电路3000的另一方面。如图18A、图28B所示,柄部组件14可包括马达3014,该马达可由马达驱动器3015控制,并可由外科器械10的击发系统使用。在各种形式中,马达3014可为直流有刷驱动马达,其具有大约例如25,000RPM的最大转速。在其他构造中,马达3014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。在某些情况下,马达驱动器3015可包括例如H桥FETs 3019,如图28A和图28B所示。马达3014可由功率组件3006供电,该功率组件能够可释放地安装到柄部组件14。功率组件3006被构造成能够将控制功率供应给外科器械10。功率组件3006可包括电池,该电池可包括串联连接的、可用作电源为外科器械10供电的多个电池单元。在这种构型中,功率组件3006可被称为电池组。在某些情况下,功率组件3006的电池单元可为可更换的和/或可再充电的。在至少一个示例中,电池单元可为能够可分离地联接到功率组件3006的锂离子电池。
适合与外科器械10一起使用的驱动系统和闭合系统的示例公开于2013年3月14日提交的名称为“CONTROL SYSTEM OF A SURGICAL INSTRUMENT”的美国临时专利申请序列号61/782,866,该专利的完整公开内容全文以引用方式并入本文。例如,电动马达3014可包括与齿轮减速器组件可操作地连接的可旋转轴(未示出),该齿轮减速器组件可与一组或一齿条的驱动齿啮合接合地安装在可纵向移动的驱动构件上。在使用中,电池所提供的电压极性可操作电动马达3014以驱动可纵向移动的驱动构件,从而使端部执行器300生效。例如,马达3014可被构造成能够驱动可纵向移动的驱动构件以推进击发机构,从而将钉从与端部执行器300组装在一起的钉仓击发到由端部执行器300捕获的组织中,和/或推进切割构件以例如切割由端部执行器300捕获的组织。
如图28A和图28B所示并且如下文更详细地描述,例如,功率组件3006可包括功率管理控制器,该功率管理控制器可被构造成能够调节功率组件3006的功率输出,以便当可互换轴组件200联接到柄部组件14(图1)时,递送第一功率输出为马达3014供电,从而推进切割构件,并且以便当可互换轴组件200联接到柄部组件14时,递送第二功率输出为马达3014供电,从而推进第二切割构件。这种调节在避免将超出联接到柄部组件14的可互换轴组件需求的过高功率传输到马达3014这方面可以是有利的。
在某些情况下,例如,通过将一个或多个通信信号路由通过位于柄部组件14(图1)中的主控制器3017,接口3024可有利于在功率管理控制器3016与轴组件控制器3022之间传输这类通信信号。在其他情况下,当轴组件200(图1)和功率组件3006联接到柄部组件14时,接口3024可有利于通过柄部组件14的功率管理控制器3016和轴组件控制器3022之间的直接通信线路。
在一种情况下,主微控制器3017可为任一种单核或多核处理器,诸如已知的由Texas Instruments生产的商品名为ARM Cortex的那些。在一个示例中,外科器械10(图1-4)可包括功率管理控制器3016,例如诸如安全微控制器平台,该安全微控制器平台包括两个基于微控制器的系列诸如同样由Texas Instruments提供的以商品名Hercules ARMCortex R4知名的TMS570和RM4x。然而,可不受限制地采用微控制器和安全处理器的其他合适的替代物。在一种情况下,安全处理器2004(图21A)可具体地针对IEC 61508和ISO 26262安全关键应用等等进行构造,以在输送可量化的性能、连通性和存储选项时提供高级集成安全特征。
在某些情况下,微控制器3017可为例如可购自Texas Instruments的LM4F230H5QR。在至少一个示例中,Texas Instruments LM4F230H5QR是ARM Cortex-M4F处理器内核,该处理器内核包括最高40MHz的256KB单周期闪速存储器或其他非易失性存储器的芯片上存储器、40MHz以上的用于提高性能的预取缓冲区、32KB单周期串行随机存取存储器(SRAM)、加载有软件的内置只读存储器(ROM)、2KB电可擦除可编程只读存储器(EEPROM)、一个或多个脉宽调制(PWM)模块、一个或多个正交编码器输入(QEI)模拟、一个或多个具有12个模拟输入通道的12位模/数转换器(ADC)、以及随时可用于产品数据表的其他特征结构。本公开不应限于这一上下文。
图29为图1的外科器械的框图,其示出了柄部组件14(图1)与功率组件之间、以及柄部组件14与可互换轴组件之间的接口。如图29所示,功率组件3006可包括功率管理电路3034,该功率管理电路可包括功率管理控制器3016、功率调制器3038和电流感测电路3036。功率管理电路3034可被构造成能够在轴组件200(图1)与功率组件3006联接到柄部组件14时,基于轴组件200的功率要求来调节电池3007的功率输出。例如,功率管理控制器3016可被编程以控制功率调制器3038调节功率组件3006的功率输出,电流感测电路3036可用于监控功率组件3006的功率输出,以便为功率管理控制器3016提供与电池3007的功率输出有关的反馈,使得功率管理控制器3016可调节功率组件3006的功率输出以维持理想的输出。
值得注意的是,功率管理控制器3016和/或轴组件控制器3022各自可包括一个或多个可存储多个软件模块的处理器和/或存储器单元。尽管可以举例的方式描述外科器械14(图1)的某些模块和/或区块,但应当理解,可使用更多或更少数量的模块和/或区块。另外,虽然各种情况可按照模块和/或块的形式描述以便于说明,但这些模块和/或块可通过一个或多个硬件部件(例如处理器、数字信号处理器(DSP)、可编程逻辑装置(PLD)、专用集成电路(ASIC)、电路、寄存器)和/或软件部件(例如程序、子例程、逻辑)、和/或硬件部件与软件部件的组合加以实施。
在某些情况下,外科器械10(图1-4)可包括输出装置3042,该输出装置可包括用于向用户提供感官反馈的一个或多个装置。此类装置可包括例如视觉反馈装置(例如,LCD显示屏、LED指示器)、听觉反馈装置(例如,扬声器、蜂鸣器)或触觉反馈装置(例如,触觉致动器)。在某些情况下,输出装置3042可包括显示器3043,该显示器可包括在柄部组件14(图1)中。轴组件控制器3022和/或功率管理控制器3016可通过输出装置3042向外科器械10的用户提供反馈。接口3024可被构造成能够将轴组件控制器3022和/或功率管理控制器3016连接到输出装置3042。读者将会知道,作为替代,输出装置3042可与功率组件3006集成。在此类情况下,当轴组件200联接到柄部组件14时,输出装置3042与轴组件控制器3022之间的通信可通过接口3024实现。
在已描述外科器械10(图1-4)和用于控制其操作的各种控制电路2000、3000的前提下,本公开现转到外科器械10和控制电路2000(或3000)的各种具体构型。
在各个方面,本公开提供了器械10(结合图1-29来描述),该器械被构造成能够在组织夹持在端部执行器的钳口构件之间例如诸如砧座与钉仓之间时感测组织压缩。在一个示例中,器械10(图1-4)可被构造成能够感测钳口构件(诸如砧座和/或钉仓)中的一者内的组织接触。又如,器械10可被构造成能够感测由钳口构件施加到组织的压力。又如,器械10可被构造成能够测量穿过钳口构件之间的组织的电阻抗(电阻)。这可通过以下方式来实现:将微电极嵌入在钳口构件中的至少一者内以驱动低幅值、低能量RF信号穿过组织,由此引起组织阻抗的非治疗性测量。能量水平保持为足够低,以避免治疗性组织效果,诸如凝固、密封、焊接、或烧灼。此外,器械10可包括装置以从单组通电和返回路径产生两个不同的测量。在一个示例中,多个频率信号可进行叠加以同时测量不同位置中的阻抗。这可包括单个有源电极,其中通道和砧座通过分离路径接地,该分离路径具有用于不同频率RF信号的滤波器。另外,可使用具有独立滤波器的两个分离返回路径,该滤波器为柄部电子系统的一部分。又如,顺序阻抗测量结果将在可变的RF频率下进行多路复用。
RF技术已在内镜切割器中应用了一段时间。采用此技术的挑战在于高密度RF能量的递送和端部执行器的钳口构件之间的短路。尽管使用RF能量在治疗学上具有缺点,但RF技术可在亚治疗学上有效地用于感测组织压缩而非实际地凝固、密封或烧灼组织。在亚治疗学意义上,内镜外科装置可采用RF能量来感测内部组织参数并且调整钉的部署,而非被用作缝合操作的辅助物以在利用刀切割组织之前密封组织。
用于内镜外科医疗装置(例如,RF内镜切割器)中的RF技术可引入操作高能量密度和处理短路的挑战。然而,如果RF技术仅用于感测组织压缩而非例如烧灼组织,则可具有较小的挑战。RF技术可用于医疗装置诸如内镜切割器以感测内部组织参数(诸如压缩)并且作为响应来调整缝合部署。RF电极和烧灼装置可在熔融组织时使用相同的电极来感测组织阻抗。这些相同的电极可基于显著较低的电和功率要求而被实现为组织压缩传感器系统。
RF电极和烧灼装置可在通过向组织施加能量焊接组织时使用相同的电极来感测组织阻抗。然而,在内镜切割器器械上下文中,相对于完全装配的电外科装置,RF电极可用作具有显著较低电子和功率需求的组织压缩传感器系统。例如仓或可能分离刀上的单个通电电极可用于同时进行多个组织压缩测量。如果多个RF信号被叠加或多路复用,则它们可沿着单个功率导体进行传输并且允许返回到该装置的通道框架或砧座上。如果滤波器在砧座和通道触点接入公共返回路径之前设置在砧座和通道触点内,则用于两个路径的组织阻抗可被区分开。这将提供穿过组织相对于侧向组织压缩的测量。相对于垂直和侧向压缩,这种滤波方法还可用于近侧和远侧组织压缩,这取决于滤波器的放置和金属导电返回路径的位置。较小的频率发生器和信号处理器可以小封装规格实现在现有的电路板或子电路板上,而不需要与RF密封烧灼系统相关联的大量额外成本。
参见图30,内镜切割器6000可包括柄部部件6002、轴部件6004、和端部执行器部件6006。内镜切割器6000以类似于结合图1-29描述的马达驱动的外科切割和紧固器械10的方式来构造和装配。因此,为简洁和清楚起见,此处将不重复操作和构造的细节。端部执行器6006可用于压缩、切割或缝合组织。现在参见图31A,端部执行器6030可在压缩、切割或缝合之前由医生进行定位以包围组织6032。如图31A所示,当准备使用端部执行器时,可未对组织施加压缩。现在参见图31B,通过接合内镜切割器的柄部(例如,柄部6002),医生可使用端部执行器6030以压缩组织6032。在一个方面,组织6032可被压缩到其最大阈值,如图31B所示。
参见图32A,可通过端部执行器6030将各种力施加到组织6032。例如,当组织6032压缩在端部执行器6030的砧座6034与通道框架6036之间时,可通过这两者施加垂直力F1和F2。现在参见图32B,当组织6032被端部执行器6030压缩时,各种对角和/或侧向力也可被施加到该组织。例如,可施加力F3。为了操作医疗装置(诸如内镜切割器6000)的目的,可期望感测或计算由端部执行器施加到组织的各种形式的压缩。例如,垂直或侧向压缩的指示可允许端部执行器更精确地或更准确地施加缝合操作,或者可通知内镜切割器的操作者以使得内镜切割器可被更正确地或安全地使用。
可从组织6032的阻抗确定穿过组织6032的压缩。在各种压缩水平下,组织6032的阻抗Z可增加或降低。通过将电压V和电流I施加到组织6032,可确定各种压缩水平下的组织6032的阻抗Z。例如,可通过施加的电压V除以电流I来计算阻抗Z。
现在参见图33,在一个方面,RF电极6038可定位在端部执行器6030上(例如,端部执行器6030的钉仓上、刀上、或通道框架上)。此外,电触点6040可定位在端部执行器6030的砧座6034上。在一个方面,电触点可定位在端部执行器的通道框架上。当组织6032在端部执行器6030的砧座6034与例如通道框架6036之间进行压缩时,组织6032的阻抗Z有所改变。由端部执行器6030引起的垂直组织压缩6042可被测量为组织6032的阻抗Z的函数。
现在参见图34,在一个方面,当RF电极6038被定位时,电触点6044可定位在端部执行器6030的砧座6034的相反端。当组织6032在端部执行器6030的砧座6034与例如通道框架6036之间进行压缩时,组织6032的阻抗Z有所改变。由端部执行器6030引起的侧向组织压缩6046可被测量为组织6032的阻抗Z的函数。
现在参见图35,在一个方面,电触点6050可定位在砧座6034上并且电触点6052可在端部执行器6030的相反端定位在通道框架6036处。RF电极6048可相对于端部执行器6030的中心被侧向地定位。当组织6032在端部执行器6030的砧座6034与例如通道框架6036之间进行压缩时,组织6032的阻抗Z有所改变。RF电极6048任一侧的侧向压缩或成角度压缩6054和6056可由端部执行器6030引起并且可基于RF电极6048与电触点6050和6052的相对定位而被测量为组织6032的不同阻抗Z的函数。
根据本公开描述的技术和特征中的一者或多者,并且如上文所讨论,RF电极可用作RF传感器。现在参见图36,在一个方面,RF传感器6062可定位在插入端部执行器的通道框架6066中的钉仓6060上。RF电极可从电力线6064延伸,该电力线可由内镜切割器的柄部(例如,柄部6002)中的电源供电。
现在参见图37,在一个方面,RF电极6074和6076可定位在插入端部执行器6070的通道框架6078中的钉仓6072上。如图所示,RF电极6074可相对于内镜切割器柄部被放置在端部执行器的近侧位置中。此外,RF电极6076可相对于内镜切割器柄部被放置在端部执行器的远侧位置中。RF电极6074和6076可用于根据端部执行器上的一个或多个电触点的位置来测量组织中的不同点处的垂直、侧向、近侧或远侧压缩。
现在参见图38,在一个方面,RF电极6084-6116可基于期望获得压缩信息的各个点而被定位在插入通道框架6080(或端部执行器的其他部件)中的钉仓6082上。现在参见图39,在一个方面,RF电极6122-6140可在期望获得压缩信息的离散点处定位在钉仓6120上。现在参见图40,RF电极6152-6172可基于压缩测量结果应精确或准确的方式而被定位在钉仓的多个区域中的不同点处。例如,RF电极6152-6156可根据区域6158中的压缩测量结果应精确或准确的方式而被定位在钉仓6150的区域6158中。此外,RF电极6160-6164可根据区域6166中的压缩测量结果应精确或准确的方式而被定位在钉仓6150的区域6166中。另外,RF电极6168-6172可根据区域6174中的压缩测量结果应精确或准确的方式而被定位在钉仓6150的区域6174中。
本文所讨论的RF电极可接线穿过插入通道框架中的钉仓。现在参见图41,在一个方面,RF电极可具有直径为约1.0mm的压印“蘑菇头”6180。尽管RF电极可具有直径为约1.0mm的压印“蘑菇头”,但这旨在为非限制性示例并且RF电极可根据每个具体的应用或设计而具有不同的形状和尺寸。RF电极可连接到、紧固到、或可形成传导线6182。传导线182可具有约0.5mm的直径,或者可基于具体的应用或设计而具有更大或更小的直径。此外,传导线可具有绝缘涂层6184。在一个示例中,RF电极可凸穿端部执行器的钉仓、通道框架、刀、或其他部件。
现在参见图42,RF电极可接线穿过端部执行器的钉仓或通道框架的单个壁或多个壁。例如,RF电极6190-6194可接线穿过端部执行器的钉仓或通道框架的壁6196。线6198中的一根或多根可连接到、紧固到RF电极6190-6194或者为这些RF电极的一部分,并且可从例如内镜切割器的柄部中的电源延伸穿过壁6196。
现在参见图43,电源可与RF电极连通,或者可通过线或缆线向RF电极提供功率。该线或缆线可接入每根单独线,并且可引向电源。例如,RF电极6204-6212可通过线或缆线6202从电源接收功率,该线或缆线可延伸穿过端部执行器的钉仓6200或通道框架。在一个示例中,RF电极6204-6212中的每一者可具有其自身的线,该线延伸到或延伸穿过线或缆线6202。钉仓6200或通道框架还可包括控制器6214,诸如结合图21A、图21B所示的控制器2006或者结合图27-29所示的其他控制器2606或3017。应当理解,控制器6214的尺寸应设定成适配在钉仓6200或通道框架中。另外,控制器
在各个方面,本文所述的与医疗装置一起使用的组织压缩传感器系统可包括频率发生器。频率发生器可位于医疗装置诸如内镜切割器的电路板上。例如,频率发生器可位于内镜切割器的轴或柄部中的电路板上。现在参见图44,示出了根据本公开的一个示例的示例电路图6220。如图所示,频率发生器6222可从6204-6212可通过线或缆线6202从电源接收6204-6212可通过线或缆线6202从电源接收6204-6212可通过线或缆线6202从电源接收电源6221接收功率或电流并且可将一个或多个RF信号提供给一个或多个RF电极6224。如上文所讨论,该一个或多个RF电极可定位在端部执行器或内镜切割器的各种位置或部件(诸如钉仓或通道框架)处。一个或多个电触点诸如电触点6226或6228可定位在端部执行器的通道框架或砧座上。此外,一个或多个滤波器诸如滤波器6230或6232可以通信的方式联接到电触点6226或6228,如图44所示。滤波器6230和6232可在频率发生器6222所提供的一个或多个RF信号接入单个返回路径6234之前对这些RF信号滤波。可使用与所述一个或多个RF信号相关联的电压V和电流I来计算与组织相关联的阻抗Z,该组织可压缩在和/或以通信的方式联接在所述一个或多个RF电极6224与电触点6226或6228之间。
现在参见图45,本文所述的组织压缩传感器系统的各种部件可位于内镜切割器的柄部6236中。例如,如电路图6220a所示,频率发生器6222可位于柄部6236中并且可从6204-6212可通过线或缆线6202从电源接收6204-6212可通过线或缆线6202从电源接收6204-6212可通过线或缆线6202从电源接收6204-6212可通过线或缆线6202从电源接收电源6221接收功率。另外,可在与电触点6228和6226对应的返回路径上测量电流I1和电流I2。利用施加在供应路径与返回路径之间的电压V,可计算阻抗Z1和Z2。Z1可与组织的阻抗相对应,该组织被压缩在和/或在RF电极6224中的一个或多个电极与电触点6228之间以通信的方式联接。此外,Z2可与组织的阻抗相对应,该组织被压缩在和/或在RF电极6224中的一者或多者与电触点6226之间以通信的方式联接。应用公式Z1=V/I1和Z2=V/I2,可计算出阻抗Z1和Z2,该阻抗Z1和Z2与由端部执行器压缩的组织的不同压缩水平相对应。
现在参见图46,本公开的一个或多个方面描述于电路图6250中。在具体实施中,内镜切割器的柄部6252处的6204-6212可通过线或缆线6202从电源接收6204-6212可通过线或缆线6202从电源接收6204-6212可通过线或缆线6202从电源接收6204-6212可通过线或缆线6202从电源接收电源可向频率发生器6254提供功率。频率发生器6254可生成一个或多个RF信号。该一个或多个RF信号可在多路复用器6256处进行多路复用或叠加,该多路复用器可位于内镜切割器的轴6258中。这样,两个或更多个RF信号可进行叠加(或者例如嵌套或调制在一起)并且传输到端部执行器。该一个或多个RF信号可对内镜切割器的端部执行器6262处(例如,定位在钉仓中)的一个或多个RF电极6260通电。组织(未示出)可压缩在和/或以通信的方式联接在RF电极6260中的一者或多者与一个或多个电触点之间。例如,组织可压缩在和/或以通信的方式联接在该一个或多个RF电极6260与定位在端部执行器6262的通道框架中的电触点6264或者定位在端部执行器6262的砧座中的电触点6266之间。滤波器6268可以通信的方式联接到电触点6264并且滤波器6270可以通信的方式联接到电触点6266。
可使用与该一个或多个RF信号相关联的电压V和电流II来计算与组织相关联的阻抗Z,该组织可压缩在钉仓(并且以通信的方式联接到一个或多个RF电极6260)和通道框架或砧座(并且以通信的方式联接到电触点6264或6266中的一者或多者)之间。
在一个方面,本文所述的组织压缩传感器系统的各种部件可位于内镜切割器的轴6258中。例如,如电路图6250所示(并且除了频率发生器6254之外),阻抗计算器6272、控制器6274、非易失性存储器6276、和通信通道6278可位于轴6258中。在一个示例中,频率发生器6254、阻抗计算器6272、控制器6274、非易失性存储器6276、和通信通道6278可定位在轴6258中的电路板上。
该两个或更多个RF信号可经由电触点返回到公共路径。此外,该两个或更多个RF信号可在RF信号接入公共路径之前进行滤波,以区分由该两个或更多个RF信号表示的单独组织阻抗。可在与电触点6264和6266相对应的返回路径上测量电流I1和电流I2。利用施加在供应路径与返回路径之间的电压V,可计算阻抗Z1和Z2。Z1可与组织的阻抗相对应,该组织被压缩在和/或在RF电极6260中的一者或多者与电触点6264之间以通信的方式联接。此外,Z2可与组织的阻抗相对应,该组织被压缩在和/或在RF电极6260中的一者或多者与电触点6266之间以通信的方式联接。应用公式Z1=V/I1和Z2=V/I2,可计算出阻抗Z1和阻抗Z2,该阻抗Z1和阻抗Z2与由端部执行器6262压缩的组织的不同压缩相对应。在该示例中,可通过阻抗计算器6272计算阻抗Z1和Z2。可使用阻抗Z1和Z2计算组织的不同压缩水平。
现在参见图47,示出了频率曲线图6290。频率曲线图6290示出了用以嵌套两个RF信号的频率调制。该两个RF信号可在到达端部执行器处的RF电极之前进行嵌套,如上所述。例如,具有频率1的RF信号和具有频率2的RF信号可嵌套在一起。现在参见图48,所得的嵌套RF信号示于频率曲线图6300中。频率曲线图6300所示的复合信号包括复合在一起的频率曲线图6290的两个RF信号。现在参见图49,示出了频率曲线图6310。频率曲线图6310示出了滤波(通过例如滤波器6268和6270)之后的具有频率1和2的RF信号。可使用所得的RF信号在返回路径上进行单独的阻抗计算或测量,如上所述。
在一个方面,滤波器6268和6270可为高品质因数(Q)滤波器,使得滤波器范围可为窄带的(例如,Q=10)。Q可由中心频率(Wo)/带宽(BW)来定义,其中Q=Wo/BW。在一个示例中,频率1可为150kHz并且频率2可为300kHz。有效的阻抗测量范围可为100kHz–20MHz。在各种示例中,可利用其他复杂技术(诸如相关性、正交检测等)来分离RF信号。
利用本文所述的技术和特征中的一者或多者,端部执行器的钉仓或分离刀上的单个通电电极可用于同时进行多个组织压缩测量。如果两个或更多个RF信号被叠加或多路复用(或者嵌套或调制),则它们可沿着端部执行器的单个功率侧进行传输并且可返回到端部执行器的通道框架或砧座上。如果滤波器在砧座和通道触点接入公共返回路径之前构建到砧座和通道触点内,则由两个路径表示的组织阻抗可被区分开。这可提供垂直组织相对于侧向组织压缩的测量。该方法还可提供近侧和远侧组织压缩,这取决于滤波器的放置和金属返回路径的位置。频率发生器和信号处理器可位于电路板或子板(其可已存在于内镜切割器中)上的一个或多个芯片上。
现在将结合各种实施例和下文列出的此类实施例的组合来描述本公开。
1.一个实施例提供了一种组织压缩传感器系统,该组织压缩传感器系统包括:定位在端部执行器上的RF电极;定位在该端部执行器的砧座或通道框架中的一者上的第一电触点;和以通信的方式联接到该第一电触点的第一滤波器。
2.另一个实施例提供了根据实施例1所述的组织压缩传感器系统,该组织压缩传感器系统还包括:定位在该端部执行器的砧座或通道框架中的一者上的第二电触点;以及以通信的方式联接到该第二电触点的第二滤波器。
3.另一个实施例提供了根据实施例2所述的组织压缩传感器系统,该组织压缩传感器系统还包括:被构造成能够将两个或更多个RF信号传输到该端部执行器的多路复用器。
4.另一个实施例提供了根据实施例2或3所述的压缩传感器系统,其中该第一和第二电触点通向公共返回路径。
5.另一个实施例提供了根据实施例3或4所述的组织压缩传感器系统,其中该RF信号沿着该端部执行器的单个功率侧进行传输。
6.另一个实施例提供了根据实施例2-5中任一项所述的组织压缩传感器系统,该组织压缩传感器系统还包括:与该第一滤波器和第二滤波器连通的阻抗计算器。
7.另一个实施例提供了根据实施例3-6中任一项所述的组织压缩传感器系统,该组织压缩传感器系统还包括:被构造成能够生成该两个或更多个RF信号的频率发生器。
8.另一个实施例提供了根据实施例1-7中任一项所述的组织压缩传感器系统,其中该RF电极定位在该端部执行器的钉仓上。
9.另一个实施例提供了根据实施例1-8中任一项所述的组织压缩传感器,该组织压缩传感器还包括:定位在该端部执行器上的离散点处的多个RF电极。
10.另一个实施例提供了根据实施例1-9中任一项所述的组织压缩传感器系统,该组织压缩传感器系统还包括:定位在该端部执行器上的多个区域中的多个RF电极。
11.另一个实施例提供了一种用于感测组织压缩的方法,该方法包括:叠加两个或更多个RF信号并且将该RF信号传输到端部执行器;使该两个或更多个RF信号经由该端部执行器的砧座或通道框架中的至少一者上的电触点返回到公共路径上;以及在该RF信号接入到该公共路径上之前对该两个或更多个RF信号滤波。
12.另一个实施例提供了根据实施例11所述的方法,该方法还包括:基于该两个或更多个RF信号中的至少一者计算与由该端部执行器压缩的组织相关联的阻抗。
13.另一个实施例提供了根据实施例11或12所述的方法,其中该两个或更多个RF信号经由多路复用器进行叠加。
14.另一个实施例提供了根据实施例11-13中任一项所述的方法,其中该两个或更多个RF信号由该端部执行器外部的频率发生器生成。
15.另一个实施例提供了根据实施例12-14中任一项所述的方法,其中基于该RF信号中的一者计算垂直组织压缩并且基于该RF信号中的另一者计算侧向组织压缩。
16.另一个实施例提供了根据实施例12-15中任一项所述的方法,其中基于该RF信号中的一者计算近侧组织压缩并且基于该RF信号中的另一者计算远侧组织压缩。
17.另一个实施例提供了根据实施例11-16中任一项所述的方法,其中两个或更多个滤波器用于在该两个或更多个RF信号接入到该公共返回路径之前对该两个或更多个RF信号进行滤波,以区分由该两个或更多个RF信号表示的单独组织阻抗。
18.另一个实施例提供了根据实施例14-17中任一项所述的方法,其中该频率发生器位于内镜切割器的轴或柄部的电路板上。
在一个方面,本公开提供了被构造成具有各种感测系统的器械10(结合图1-29进行描述)。因此,为简洁和清楚起见,此处将不重复操作和构造的细节。在一个方面,感测系统包括粘弹性/变化速率感测系统以监控刀加速度、阻抗的变化速率、和组织接触的变化速率。在一个示例中,刀加速度的变化速率可用作组织类型的量度。又如,阻抗的变化速率可利用脉冲传感器进行测量并且可用作压缩率的量度。最后,可利用传感器并基于刀击发速率来测量组织接触的变化速率以测量组织流动。
所感测参数的变化速率或者换句话讲组织参数达到渐近稳态值所需的时间本身为单独的量度并且可比所感测参数(变化速率从其导出)更有价值。为了增强组织参数的测量(诸如,在进行测量之前等待预先确定的时间量),本公开提供了采用量度的导数(诸如,组织参数的变化速率)的新型技术。
考虑到不存在可单独用于显著改善钉成形的单个量度,导数技术或变化速率量度变为最有用的。其为使量度有效的多个量度的组合。就组织间隙而言,有益的是知道钳口被组织覆盖的量以使间隙量度相关。阻抗的变化速率量度可与砧座中的应变量度进行组合以使力与施加到抓持在端部执行器的钳口构件(诸如砧座和钉仓)之间的组织的压缩相关联。变化速率量度可被内镜外科装置用于确定组织类型而非仅组织压缩。尽管当肺组织发生钙化时,胃和肺组织有时具有类似的厚度和甚至类似的压缩特性,但器械可能够通过采用量度(诸如,间隙、压缩、所施加的力、组织接触面积、以及压缩的变化速率或间隙的变化速率)的组合来区分这些组织类型。如果仅使用这些量度中的任一者,则内镜外科装置可难以区分开组织类型。压缩的变化速率还可有助于允许装置确定组织是否“正常”或者是否存在一些异常。不仅测量已消耗的时间量而且测量传感器信号的变化并且确定信号的导数将提供另一个量度以允许内镜外科装置测量该信号。变化速率信息还可用于确定何时已达到稳态,由此发信号通知进行过程中的下一步骤。例如,在将组织夹持在端部执行器的钳口构件(诸如砧座和钉仓)之间之后,当组织压缩达到稳态(例如,约15秒)时,可启用指示器或触发器以击发该装置。
本文还提供了用于传感器数据的时间依赖性评估的方法、装置和系统,以确定外科器械操作期间的组织的稳定性、蠕变和粘弹性特性。外科器械10(诸如图1所示的缝合器)可包括多种传感器以用于测量操作参数,诸如,钳口间隙尺寸或距离、击发电流、组织压缩、由组织覆盖的钳口量、砧座应变和触发器力等等。这些感测的量度对于外科器械的自动控制以及向临床医生提供反馈是重要的。
结合图30-49示出的示例可用于测量各种导出参数,诸如,相对于时间的间隙距离、相对于时间的组织压缩、和相对于时间的砧座应变。可利用如结合图24所述的与电池2308串联的电流传感器2312、图25所示的与电池2408串联的电流传感器2412、或者图29中的电流传感器3026来监控马达电流。
现在转到图50,示出了可再利用或不可再利用的马达驱动的外科切割和紧固器械8010。马达驱动的外科切割和紧固器械8010以类似于结合图1-29描述的马达驱动的外科切割和紧固器械10的方式来构造和装配。在图50所示的示例中,器械8010包括外壳8012,该外壳包括被构造成能够被临床医生抓握、操纵和致动的柄部组件8014。外壳8012被构造用于可操作地附接到可互换轴组件8200,该可互换轴组件上可操作地联接有外科端部执行器8300,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外科手术。因为马达驱动的外科切割和紧固器械8010以类似于结合图1-29所述的马达驱动的外科切割和紧固器械10(图1-4)的方式来构造和装配,所以为简洁和清楚起见,此处将不重复操作和构造的细节。
图50中所示的外壳8012结合包括端部执行器8300的可互换轴组件8200示出,该端部执行器包括被构造成能够可操作地支撑其中的外科钉仓8304的外科切割和紧固装置。外壳8012可被构造用于结合可互换轴组件使用,该可互换轴组件包括适于支撑不同尺寸和类型的钉仓的端部执行器,并具有不同的轴长度、尺寸和类型等。此外,外壳8012也可有效地与多种其他可互换轴组件一起使用,所述其他可互换轴组件包括被构造成能够将其他动作和能量形式(例如诸如,射频(RF)能量、超声能量和/或动作)施加到适于结合各种外科应用和外科手术使用的端部执行器构造的那些组件。此外,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何合适的一个或多个紧固件来紧固组织。例如,包括多个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。
图50示出了具有可操作地联接到其的可互换轴组件8200的外科器械8010。在示出的构造中,柄部外壳形成可被临床医生抓握和操纵的手枪式握把部8019。柄部组件8014在其中可操作地支撑多个驱动系统,该多个驱动系统被构造成能够生成并将各种控制动作施加到可操作地附接到其的可互换轴组件的对应部分。触发器8032与手枪式握把可操作地相联以用于控制这些控制动作中的各个动作。
继续参考图50,可互换轴组件8200包括外科端部执行器8300,该外科端部执行器包括被构造成能够可操作地支撑其中的钉仓8304的细长通道8302。端部执行器8300还可包括砧座8306,该砧座相对于细长通道8302可枢转地支撑。
发明人已发现,相比于所感测参数(导出的参数以其为基础),导出的参数能够甚至更有效地用于控制外科器械,诸如图50所示的器械。导出的参数的非限制性示例包括所感测参数(例如,钳口间隙距离)的变化速率以及组织参数达到渐近稳态值之前消耗的时间(例如,15秒)。导出的参数(诸如变化速率)为尤其可用的,因为它们显著地改善测量精确性并且还提供原本直接从所感测参数并不显而易见的信息。例如,阻抗(即,组织压缩)变化速率可与砧座中的应变进行组合,以使压缩与力相关联,这可允许微控制器确定组织类型而不仅仅组织压缩量。此示例仅为例示性的,并且任何导出的参数可与一个或多个所感测参数进行组合以提供有关组织类型(例如,胃相比于肺)、组织健康状态(例如,钙化相比于正常)、和外科器械操作状态(例如,夹持完成)的更精确信息。不同的组织具有独特的粘弹性特性和独特的变化速率,这使得本文讨论的这些参数和其他参数称为可用的指标以监控和自动地调整外科手术。
图52A-52E示出了示例性的感测参数以及从其导出的参数。图52A为示出随时间推移的间隙距离的例示性曲线图,其中间隙为由所夹持组织占据的钳口之间的间距。竖直(y)轴为距离并且水平(x)轴为时间。具体地,参见图50和图51,间隙距离8040为端部执行器的砧座8306与细长通道8302之间的距离。在打开的钳口位置,砧座8306与细长构件之间的间隙8040处于其最大距离。间隙8040的宽度诸如在组织夹持期间随着砧座8306闭合而减小。T间隙距离变化速率可有所变化,因为组织具有不均一的弹性。例如,某些组织类型可初始显示具有快速的压缩,从而导致较快的变化速率。然而,当组织被继续压缩时,组织的粘弹性特性可导致变化速率降低,直到组织不能被进一步压缩,此时间隙距离将保持基本上恒定。当组织在端部执行器8040的砧座8306和钉仓8304进行挤压时,间隙随时间推移而减小。结合图30-49和图55所述的一个或多个传感器(例如诸如,磁场传感器、应变仪、压力传感器、力传感器、电感传感器(例如诸如涡流传感器)、电阻传感器、电容传感器、光学传感器、和/或任何其他合适的传感器)可适于并且被构造成能够测量砧座8306与钉仓8304之间的随时间“t”推移的间隙距离“d”,如图52A中以图形方式表示。间隙距离“d”随时间“t”推移的变化速率为图52A所示的曲线的斜率,其中斜率=Δd/Δt。
图52B为示出端部执行器钳口的击发电流的例示性曲线图。竖直(y)轴为电流并且水平(x)轴为时间。如本文所讨论,如图21-29所示的外科器械和/或微控制器可包括电流传感器,该电流传感器检测各种操作(诸如,夹持、切割和/或缝合组织)期间所采用的电流。例如,当组织阻抗增加时,器械的电动马达可需要更大的电流来夹持、切割和/或缝合组织。相似地,如果阻抗较低,则电动马达可需要较小的电流来夹持、切割和/或缝合组织。因此,击发电流可用作组织阻抗的近似值。所感测的电流可单独使用,或者更优选地,可结合其他量度来使用以提供有关靶组织的反馈。仍参见图52B,在一些操作(诸如缝合)期间,击发电流初始在时间零时刻为高的,但随时间推移而降低。在其他装置操作期间,如果马达消耗更多的电流来克服递增的机械负荷,则电流可随时间推移而增加。此外,击发电流的变化速率可用作组织从一个状态转变到另一个状态的指示指标。因此,击发电流并且具体地击发电流的变化速率可用于监控装置操作。当刀切割穿过组织时,击发电流可随时间推移而降低。如果被切割的组织因组织特性或刀8305(图51)的锐度而提供更高或更低的阻抗,则击发电流的变化速率可有所变化。当切割状态改变时,由马达完成的工作有所变化并且因此将改变随时间推移的击发电流。电流传感器可用于在刀8305正击发期间测量随时间推移的击发电流,如图52B中以图形方式表示。例如,可利用如结合图24所述的与电池2308串联的电流传感器2312、图25所示的与电池2408串联的电流传感器2412、或者图29所示的电流传感器3026来监控马达电流。电流传感器2312、2314、3026可适于并且被构造成能够测量随时间“t”推移的马达击发电流“i”,如图52B中以图形方式表示。击发电流“i”随时间“t”推移的变化速率为图52B所示的曲线的斜率,其中斜率=Δi/Δt。
图52C为阻抗随时间推移的例示性曲线图。竖直(y)轴为阻抗并且水平(x)轴为时间。在时间零时刻,阻抗为低的,但当组织压力在操纵(例如,夹持和缝合)下增加时则随时间推移而增加。变化速率随时间推移而有所变化,因为端部执行器8040的砧座8306和钉仓8304之间的组织被刀切断或者利用位于端部执行器8040的砧座8306和钉仓8304之间的电极间的RF能量进行密封。例如,当组织被切割时,电阻抗增加并且当组织被刀完全切断时达到无穷大。另外,如果端部执行器8040包括联接到RF能量源的电极,则组织的电阻抗随着能量被递送穿过端部执行器8040的砧座8306和钉仓8304之间的组织而增加。当穿过组织的能量通过蒸发组织中的水分而使组织变干时,电阻抗增加。最后,当合适量的能量被递送到组织时,阻抗在组织被切断时增加到极高值或无穷大。另外,如图52C所示,不同的组织可具有独特的压缩特性,诸如压缩速率,该压缩特性可区分组织。可通过驱动亚治疗RF电流穿过抓持在第一钳口构件9014和第二钳口构件9016之间的组织来测量组织阻抗。一个或多个电极可定位在砧座8306和钉仓8304中的一者或两者上。可测量砧座8306与钉仓8304之间的组织随时间推移的组织压缩/阻抗,如图52C中以图形方式表示。结合图30-49和图55所述的传感器(例如诸如,磁场传感器、应变仪、压力传感器、力传感器、电感传感器(例如诸如涡流传感器)、电阻传感器、电容传感器、光学传感器、和/或任何其他合适的传感器)可适于并且被构造成能够测量组织压缩/阻抗。这些传感器可适于并且被构造成能够测量随时间“t”推移的组织阻抗“Z”,如图52C中以图形方式表示。组织阻抗“Z”随时间“t”推移的变化速率为图78C所示的曲线的斜率,其中斜率=ΔZ/Δt。
图52D为砧座8306(图50、图51)应变随时间推移的例示性曲线图。竖直(y)轴为应变并且水平(x)轴为时间。在缝合期间,例如,砧座8306应变初始为高的,但随着组织达到稳态并且将较小的压力施加到砧座8306上而降低。可通过定位在砧座8306和钉仓8304(图50、图51)中的一者或两者上的压力传感器或应变仪测量砧座8306应变的变化速率,以测量施加到抓持在砧座8306和钉仓8304之间的组织的压力或应变。可测量随时间推移的砧座8306应变,如图52D中以图形方式表示。应变“S”随时间“t”推移的变化速率为图52D所示的曲线的斜率,其中斜率=ΔS/Δt。
图52E为触发器力随时间推移的例示性曲线图。竖直(y)轴为触发器力并且水平(x)轴为时间。在某些示例中,触发器力为渐进式的,从而为临床医生提供触觉反馈。因此,在时间零时刻,触发器8020(图50)可处于其最小值,并且触发器压力可在操作(例如,夹持、切割或缝合)完成之前增加。可通过定位在器械8010(图50)的柄部8019的触发器8302上的压力传感器或应变仪测量触发器力的变化速率,以测量驱动刀8305(图51)穿过抓持在砧座8306和钉仓8304之间的组织所需的力。可测量随时间推移的触发器8032力,如图52E中以图形方式表示。应变触发器力“F”随时间“t”推移的变化速率为图52E所示的曲线的斜率,其中斜率=ΔF/Δt。
例如,胃和肺组织可被区分开,尽管这些组织可具有类似的厚度并且可在肺组织发生钙化的情况下具有类似的压缩特性。可通过分析钳口间隙距离、组织压缩、所施加的力、组织接触面积、压缩变化速率和钳口间隙变化速率来区分胃和肺组织。例如,图53示出了用于各种组织的组织压力“P”相对于组织位移的曲线图。竖直(y)轴为组织压力并且水平(x)轴为组织位移。当组织压力达到预先确定的阈值(诸如50-100磅每平方英寸(psi))时,达到阈值之前的组织位移量以及组织位移速率可用于区分组织。例如,相比于结肠、肺或胃组织,血管组织以较小的组织位移和较快的变化速率达到预先确定的压力阈值。另外,血管组织的变化速率(相对于位移的组织压力)在50-100psi的阈值下为渐近的,而结肠、肺和胃的变化速率在50-100psi的阈值下并非为渐近的。应当理解,可使用任何压力阈值,例如诸如,1psi-1000psi,更优选地10至500psi,并且还更优选地50至100psi。另外,可使用多个阈值或渐进阈值以提供具有类似粘弹性特性的组织类型的进一步分辨。
压缩变化速率还可允许微控制器确定组织是否“正常”或者是否存在一些异常(诸如钙化)。例如,参见图54,相比于正常肺组织的压缩,钙化肺组织的压缩遵循不同的曲线。组织位移和组织位移的变化速率因此可用于诊断和/或区分钙化的肺组织与正常的肺组织。
另外,某些感测的量度可受益于另外的传感器输入。例如,就钳口间隙而言,已知钳口被组织覆盖的程度可使得间隙测量结果更有用和更精确。如果钳口的小部分被组织覆盖,则相比于整个钳口被组织覆盖,组织压缩可似乎为较小的。因此,当分析组织压缩和其他感测参数时,钳口覆盖量可被微控制器考虑在内。
在某些情况下,实耗时间也可为重要的参数。测量已消耗的时间并结合感测的参数和导出的参数(例如,变化速率)提供另外的有用信息。例如,如果钳口间隙变化速率在设定时间段(例如,5秒)之后保持恒定,则该参数可已达到其渐近值。
变化速率信息还可用于确定何时已达到稳态,由此发信号通知进行过程中的下一步骤。例如,在夹持期间,当组织压缩达到稳态(例如,在设定时间段之后未产生显著的变化速率)时,微控制器可将信号发送到显示器,由此提示临床医生启动操作中的下一步骤,诸如钉击发。另选地,微控制器可进行编程以在一旦达到稳态就自动地启动操作中的下一阶段(例如,钉击发)。
相似地,阻抗变化速率可与砧座中的应变进行结合以使力与压缩相关联。变化速率将允许装置确定组织类型而非仅测量压缩值。例如,胃和肺组织有时具有类似的厚度并且在肺发生钙化时甚至具有类似的压缩特性。
一个或多个所感测参数与导出参数的组合为组织类型和组织健康状态提供更可靠和更精确的评估,并且允许更好的组织监控、控制和临床医生反馈。
现在转到图55,端部执行器9012为端部执行器8300(图50)的一个方面,该端部执行器8300可适于利用外科器械8010(图50)操作以测量各种导出的参数,诸如,相对于时间的间隙距离、相对于时间的组织压缩、和相对于时间的砧座应变。因此,图55所示的端部执行器9012可包括一个或多个传感器,该一个或多个传感器被构造成能够测量一个或多个参数或特性,该一个或多个参数或特性与端部执行器9012和/或由端部执行器9012捕获的组织节段相关联。在图55所示的示例中,端部执行器9012包括第一传感器9020和第二传感器9026。在各种示例中,第一传感器9020和/或第二传感器9026可包括例如磁传感器(例如诸如磁场传感器)、应变仪、压力传感器、力传感器、电感传感器(例如诸如涡流传感器)、电阻传感器、电容传感器、光学传感器、和/或用于测量端部执行器9012的一个或多个参数的任何其他合适的传感器。
在某些情况下,第一传感器9020和/或第二传感器9026可包括例如磁场传感器,该磁场传感器嵌入在第一钳口构件9014中并且被构造成能够检测由嵌入在第二钳口构件9016和/或钉仓9018中的磁体9024产生的磁场。检测到的磁场的强度可与例如位于钳口构件9014、9016之间的组织的厚度和/或咬合完全性相对应。在某些情况下,第一传感器9020和/或第二传感器9026可包括应变仪例如诸如微应变仪,该应变仪被构造成能够测量夹持状态期间的砧座9014中的应变量值。应变仪提供电信号,该电信号的幅值随着应变量值而变化。
在一些方面,端部执行器9012的一个或多个传感器中(例如诸如第一传感器9020和/或第二传感器9026)可包括压力传感器,该压力传感器被构造成能够检测由存在于钳口构件9014、9016之间的压缩组织产生的压力。在一些示例中,端部执行器9012的一个或多个传感器(例如诸如第一传感器9020和/或第二传感器9026)被构造成检测位于钳口构件9014、9016之间的组织节段的阻抗。检测到的阻抗可指示位于钳口构件9014、9016之间的组织的厚度和/或完全性。
在一个方面,端部执行器9012的传感器中的一个或多个(例如诸如第一传感器9012)被构造成能够测量砧座9014和第二钳口构件9016之间的间隙9022。在某些情况下,间隙9022可表示夹持在钳口构件9014、9016之间的组织节段的厚度和/或压缩率。在至少一个示例中,间隙9022可等于或基本上等于夹持在钳口构件9014、9016之间的组织节段的厚度。在一个示例中,端部执行器9012的传感器中的一者或多者(例如诸如第一传感器9020)被构造成能够测量由第二钳口构件9016和/或夹持在砧座9014和第二钳口构件9016之间的组织施加到砧座9014上的一个或多个力。施加到砧座9014上的力可表示由捕获在钳口构件9014、9016之间的组织节段经受的组织压缩。在一个实施方案中,砧座9014和第二钳口构件9016之间的间隙9022可通过以下方式进行测量:将磁场传感器定位在砧座9014上并且将磁体定位在第二钳口构件9016上,使得间隙9022与磁场传感器所检测的信号成比例并且该信号与磁体和磁场传感器之间的距离成比例。应当理解,磁场传感器和磁体的位置可进行交换,使得磁场传感器定位在第二钳口构件9016上并且磁体放置在砧座9014上。
传感器中的一者或多者(例如诸如第一传感器9020和/或第二传感器9026)可在夹持操作期间实时地测量。实时测量结果允许基于时间的信息例如被处理器分析并且用于选择一个或多个算法和/或查找表,以便实时地评估外科器械9010的操作者的手动输入。此外,可向操作者提供实时反馈以有助于操作者校正手动输入,从而产生期望的输出。
现在将结合各种实施例和下文列出的此类实施例的组合来描述本公开。
1.一个实施例提供了一种电动外科切割和缝合器械,该电动外科切割和缝合器械包括:用以测量与该器械相关联的至少一个参数的至少一个传感器;至少一个处理器;与处理器可操作地相关联的存储器,该存储器包括机器可执行指令,该机器可执行指令在由处理器执行时导致处理器:在预先确定的时间段上监控该至少一个传感器;以及确定该测量参数的变化速率。
2.另一个实施例提供了根据实施例1所述的电动外科切割和缝合器械,该电动外科切割和缝合器械包括第一钳口构件和第二钳口构件,其中该第一钳口构件和第二钳口构件中的至少一者能够相对于该另一个钳口构件运动,并且其中该至少一个传感器定位在该第一钳口构件和第二钳口构件中的至少一者上。
3.另一个实施例提供了根据实施例2所述的电动外科切割和缝合器械,该电动外科切割和缝合器械还包括:定位在该第一钳口构件上的磁体;磁场传感器,其中该磁场传感器联接到该处理器并且该处理器被构造成能够基于从该磁场传感器接收的信号确定该第一钳口构件和第二钳口构件之间的间隙距离,其中来自该磁场传感器的该信号与该磁体和该磁场传感器之间的该间隙距离成比例,其中该处理器被构造成能够监控预先确定的时间段上的该间隙距离以确定预先确定的时间段上的该间隙的变化速率。
4.另一个实施例提供了根据实施例2或3所述的电动外科切割和缝合器械,该电动外科切割和缝合器械还包括:限定在该第一钳口构件或第二钳口构件中的至少一者中的刀通道,其中该通道被构造成能够沿其平移刀;被构造成能够沿着该刀通道平移的刀;可操作地联接到该刀以沿着该刀通道推进和缩回该刀的马达;以及电流传感器,该电流传感器被构造成能够在该马达推进该刀以切割抓持在该第一钳口构件和第二钳口构件之间的组织时测量该马达的电流消耗;其中该处理器被构造成能够接收该预先确定的时间段上的来自该电流传感器的信号,其中该信号表示推进该刀穿过该组织时的该马达的电流消耗;并且其中该处理器被构造成能够当该马达在该预先确定的时间段上推进该刀穿过该组织时确定该马达的电流消耗的变化速率。
5.另一个实施例提供了根据实施例2-4中任一项所述的电动外科器械,该电动外科器械还包括力传感器,该力传感器定位在该第一钳口或第二钳口中的至少一者中以测量抓持在该第一钳口构件和第二钳口构件之间的组织的压缩,其中该处理器被构造成能够接收该预先确定的时间段上的来自该力传感器的信号,其中该信号表示该组织压缩,并且其中该处理器被构造成能够确定该预先确定的时间段上的组织压缩的变化速率。
6.另一个实施例提供了根据实施例2-5中任一项所述的电动外科器械,该电动外科器械还包括联接到亚治疗射频(RF)能量源的至少一个电极,该亚治疗射频(RF)能量源被构造成能够驱动低能量水平RF信号穿过抓持在该第一钳口构件和第二钳口构件之间的组织以测量该组织的电阻抗;其中该处理器被构造成能够接收该预先确定的时间段上的来自该至少一个电极的信号,其中该信号表示该组织阻抗,并且其中该处理器被构造成能够确定该预先确定的时间段上的组织阻抗的变化速率。
7.另一个实施例提供了根据实施例2-6中任一项所述的电动外科器械,该电动外科器械还包括应变仪,该应变仪定位在该第一钳口构件或第二钳口构件中的能够运动的钳口构件内以在组织抓持在该第一和钳口构件第二钳口构件之间时测量该钳口构件的应变,其中该处理器被构造成能够接收该预先确定的时间段上的来自该应变仪的信号,其中该信号表示该能够运动的钳口构件的应变,并且其中该处理器被构造成能够确定该预先确定的时间段上的该应变的变化速率。
8.另一个实施例提供了根据实施例1-7中任一项所述的电动外科切割和缝合器械,该电动外科切割和缝合器械包括柄部;能够相对于该柄部运动的触发器;以及定位在该能够运动的触发器上的压力传感器或应变仪;其中该处理器被构造成能够接收该预先确定的时间段上的来自该应变仪的信号,其中该信号表示施加到该能够运动的触发器的该力,并且其中该处理器被构造成能够确定该预先确定的时间段上的该力的变化速率。
9.另一个实施例提供了一种电动外科切割和缝合器械,该电动外科切割和缝合器械包括端部执行器,该端部执行器包括第一钳口构件和第二钳口构件,其中该第一钳口构件和第二钳口构件中的至少一者能够相对于该另一个钳口构件运动,并且其中该至少一个传感器定位在该第一钳口构件和第二钳口构件中的至少一者上;定位在该第一钳口构件或第二钳口构件的至少一者中的压力传感器或应变仪;至少一个处理器;与该处理器可操作地相关联的存储器,该存储器包括机器可执行指令,该机器可执行指令在由该处理器执行时导致该处理器:监控施加到抓持在该第一钳口构件和第二钳口构件之间的组织的该压力;以及基于该组织压力测量结果确定抓持在该第一钳口构件和第二钳口构件之间的组织的类型。
10.另一个实施例提供了根据实施例9所述的电动外科器械,其中该处理器被构造成能够通过测量沿第一轴线和沿第二轴线的组织压力来确定组织位移,其中该第一和第二轴线相对于彼此为横向的。
11.另一个实施例提供了根据实施例10所述的电动外科器械,其中当组织压力达到预先确定的阈值时,达到该阈值之前的该组织位移量以及该组织位移速率用于区分组织类型。
12.另一个实施例提供了根据实施例10或11所述的电动外科器械,其中该处理器被构造成能够基于多个阈值或渐进阈值确定组织位移以提供具有类似粘弹性特性的组织类型的更高分辨力。
13.另一个实施例提供了一种电动外科切割和缝合器械,该电动外科切割和缝合器械包括端部执行器,该端部执行器包括第一钳口构件和第二钳口构件,其中该第一钳口构件和第二钳口构件中的至少一者能够相对于该另一个钳口构件运动,并且其中该至少一个传感器定位在该第一钳口构件和第二钳口构件中的至少一者上;定位在该第一钳口构件或第二钳口构件中的至少一者中的压力传感器或应变仪;用以测量该第一钳口构件和第二钳口构件之间的间隙距离的间隙传感器;至少一个处理器;与该处理器可操作地相关联的存储器,该存储器包括机器可执行指令,该机器可执行指令在由该处理器执行时导致该处理器:监控施加到抓持在该第一钳口构件和第二钳口构件之间的组织的该压力;监控该第一钳口构件和第二钳口构件之间的间隙距离;以及基于该组织压力和该间隙距离测量结果确定抓持在该第一钳口构件和第二钳口构件之间的组织的类型。
14.另一个实施例提供了根据实施例13所述的电动外科切割和缝合器械,其中该压力和间隙距离测量结果被该处理器用于确定抓持在该第一钳口构件和第二钳口构件之间的组织量。
15.另一个实施例提供了根据实施例14所述的电动外科切割和缝合器械,其中当该第一钳口构件和第二钳口构件中的小部分被组织覆盖时,该处理器被构造成能够补偿组织压缩测量结果。
16.另一个实施例提供了根据实施例14或15所述的电动外科切割和缝合器械,其中该处理器被构造成能够确定实耗时间以及压力和间隙距离测量结果以确定导数参数。
17.另一个实施例提供了根据实施例16所述的电动外科切割和缝合器械,其中该处理器被构造成能够在设定的时间段后变化速率保持恒定时确定测量的参数已达到渐近值。
18.另一个实施例提供了根据实施例16或17所述的电动外科切割和缝合器械,其中该处理器采用变化速率信息来确定何时已达到稳态并且由此发信号通知进行过程中的下一步骤。
19.另一个实施例提供了根据实施例18所述的电动外科切割和缝合器械,其中该处理器被构造成能够将信号发送到显示器,由此警示该器械的用户启动该过程中的下一步骤,或者处理器被构造成能够一旦达到稳态就自动地启动该过程的下一步骤。
20.另一个实施例提供了根据实施例16-19中任一项所述的电动外科切割和缝合器械,其中该处理器被构造成能够组合阻抗变化速率与该第一钳口构件和第二钳口构件中的至少一者中的应变以使力与压缩相关。
根据各种实施例,本文所述的外科器械可包括联接到各种传感器的一个或多个处理器(例如,微处理器、微控制器)。除一个或多个处理器外,存储装置(具有操作逻辑器)和通信接口还彼此联接。
如前所述,传感器可被构造成能够检测和采集与外科装置相关联的数据。处理器处理从传感器接收的传感器数据。
处理器可被构造成能够执行操作逻辑。处理器可为本领域中已知的多个单核或多核处理器中的任一者。存储装置可包括被构造成能够存储操作逻辑器的永久和临时(工作)拷贝的易失性和非易失性存储介质。
在各个方面,操作逻辑器可被构造成能够执行初始处理,并且将数据传输到托管应用程序的计算机以确定和产生指令。对于这些实施例,操作逻辑器可被进一步构造成能够从托管计算机接收信息并且向其提供反馈。在另选实施例中,操作逻辑器可被构造成能够在接收信息和确定反馈中扮演更重要的角色。在任一种情况下,无论是其独立确定还是响应于来自托管计算机的指令,操作逻辑器可以被进一步构造成能够控制反馈并向使用者提供反馈。
在各个方面,操作逻辑器可由处理器的指令集架构(ISA)所支持的指令来实施,或者以更高级语言来实施,并且编译成受支持的ISA。操作逻辑器可包括一个或多个逻辑单元或模块。操作逻辑器可以面向对象的方式来实施。操作逻辑器可被构造成能够以多任务方式和/或多线程方式来执行。在其他实施例中,操作逻辑器可在诸如门阵列的硬件中实施。
在各种方面,通信接口可被构造成能够有利于外围设备与计算系统之间的通信。该通信可包括将所收集的与位置、姿势相关联的生物计量数据和/或使用者身体部分的运动数据传送到托管计算机,以及将与触觉反馈相关联的数据从主计算机传送到外围设备。在各种实施例中,通信接口可为有线或无线通信接口。有线通信接口的示例可包括但不限于通用串行总线(USB)接口。无线通信接口的示例可包括但不限于蓝牙接口。
对于各个方面,处理器可与操作逻辑器封装在一起。在各种实施例中,处理器可与操作逻辑器封装在一起以形成SiP。在各种实施例中,处理器可在相同裸片上与操作逻辑器一起集成。在各种实施例中,处理器可与操作逻辑器封装在一起以形成片上系统(SoC)。
各个方面可在本文中于计算机可执行指令的一般背景中进行描述,该计算机可执行指令诸如软件、程序模块、和/或正由处理器执行的引擎。一般来讲,软件、程序模块、和/或引擎包括被布置成执行特定操作或实现特定抽象数据类型的任何软件元件。软件、程序模块、和/或引擎可包括执行特定任务或实施特定抽象数据类型的例程、程序、对象、部件、数据结构等。软件、程序模块、和/或引擎部件和技术的具体实施可存储在某种形式的计算机可读介质上并且/或者通过某种形式的计算机可读介质传输。就此而言,计算机可读介质可以是可用于存储信息并且可由计算设备访问的任何可用介质。一些实施例还可在分布式计算环境中实践,在该分布式计算环境中,操作由通过通信网络链接的一个或多个远程处理设备执行。在分布式计算环境中,软件、程序模块和/或引擎可位于包括存储器存储装置在内的本地和远程计算机存储介质两者中。可采用存储器(诸如随机存取存储器(RAM)或其他动态存储装置)来存储信息以及待由处理器执行的指令。存储器还可用于在执行待由处理器执行的指令期间存储临时变量或其他中间信息。
虽然可将一些方面例示和描述为包括功能部件、软件、引擎、和/或执行各种操作的模块,但应当理解,此类部件或模块可由一个或多个硬件部件、软件部件、和/或它们的组合实现。功能部件、软件、引擎、和/或模块可由例如待被逻辑设备(例如,处理器)执行的逻辑(例如,指令、数据、和/或代码)实现。这种逻辑可存储在位于一种或多种类型的计算机可读存储介质上的逻辑设备内部或外部。在其他实施例中,功能部件诸如软件、引擎、和/或模块可由硬件元件实现,该硬件元件可包括处理器、微处理器、电路、电路元件(例如,晶体管、电阻器、电容器、电感器等)、集成电路、ASIC、PLD、DSP、FPGA、逻辑门、寄存器、半导体设备、芯片、微芯片、芯片组,等等。
软件、引擎和/或模块的示例可包括软件部件、程序、应用、计算机程序、应用程序、系统程序、机器程序、操作系统软件、中间件、固件、软件模块、例程、子例程、函数、方法、过程、软件接口、应用程序接口(API)、指令集、计算代码、计算机代码、代码片段、计算机代码片段、字、值、符号、或它们的任何组合。确定一个实施例是否使用硬件元件和/或软件元件来实现可以根据任何数量的因素改变,这些因素诸如期望的计算速率、功率水平、热容差、处理循环预算、输入数据速率、输出数据速率、存储器资源、数据总线速度以及其他设计或性能约束。
本文所述的模块中的一者或多者可包括实施为固件、软件、硬件或它们的任意组合的一个或多个嵌入式应用程序。本文所述的模块中的一者或多者可包括各种可执行模块,诸如软件、程序、数据、驱动器、应用程序API等等。固件可存储在控制器和/或控制器的可包括非易失性存储器(NVM)的存储器诸如位屏蔽只读存储器(ROM)或闪存存储器中。在各种具体实施中,将固件存储在ROM中可保护闪存存储器。NVM可包括其他类型的存储器,包括例如可编程ROM(PROM)、可擦除可编程ROM(EPROM)、EEPROM或电池支持的RAM(诸如动态RAM(DRAM)、双数据率DRAM(DDRAM)和/或同步DRAM(SDRAM))。
在一些情况下,各个方面可实现为制造制品。该制造制品可包括被布置为存储用于执行一个或多个实施例的各种操作的逻辑、指令和/或数据的计算机可读存储介质。在各种实施例中,例如,该制品可包括磁盘、光盘、闪存存储器或固件,这些制品均含有适于由通用处理器或专用处理器执行的计算机程序指令。然而,实施例并不仅限于此。
结合本文所公开的实施例描述的各种功能性元件、逻辑块、模块、和电路元件的功能可在计算机可执行指令的一般环境中实施,诸如由处理单元执行的软件、控制模块、逻辑、和/或逻辑模块。一般而言,软件、控制模块、逻辑、和/或逻辑模块包括布置成执行特定操作的任何软件元件。软件、控制模块、逻辑、和/或逻辑模块可包括执行特定任务或实施特定抽象数据类型的例程、程序、对象、部件、数据结构等。软件、控制模块、逻辑器、和/或逻辑模块和技术的具体实施可存储在某种形式的计算机可读介质上并且/或者通过某种形式的计算机可读介质传输。就此而言,计算机可读介质可以是可用于存储信息并且可由计算设备访问的任何可用介质。一些实施例还可在分布式计算环境中实践,在该分布式计算环境中,操作由通过通信网络链接的一个或多个远程处理设备执行。在分布式计算环境中,软件、控制模块、逻辑器和/或逻辑模块可位于包括存储器存储设备在内的本地和远程计算机存储介质两者中。
此外,应当理解,本文所述的实施例阐明了示例性具体实施,并且功能性元件、逻辑块、模块和电路元件可以与所述实施例一致的各种其他方式来实施。此外,由此类功能性元件、逻辑块、模块和电路元件执行的操作可组合和/或分离以用于给定的具体实施,并且可由更多数量或更少数量的部件或模块来执行。如本领域技术人员在阅读本公开之后所显而易见的,本文所述和所示的单独实施例中的每个具有离散部件和特征,在不背离本公开的范围的前提下,所述部件和特征可容易地与其他若干方面中任意方面的特征分离或组合。可按所述事件的顺序或按任何其他在逻辑上可能的顺序来执行任何所述方法。
值得注意的是,任何对“一个实施例”或“实施例”的提及均意指结合实施例所述的特定特征、结构或特性包括在至少一个实施例中。在说明书中各处出现的短语“在一个实施例中”或“在一个方面”并不一定全部是指相同的实施例。
除非另外特别说明,否则应当理解,术语诸如“处理”、“运算”、“计算”、“确定”等是指计算机或计算系统、或类似电子计算装置的动作和/或过程,所述电子计算装置诸如通用处理器、DSP、ASIC、FPGA或其他可编程逻辑装置、离散门或晶体管逻辑、离散硬件部件,或它们的任何组合,其被设计以执行本文所述的功能,其操纵表示为寄存器和/或存储器内的物理量(例如,电子)的数据并且/或者将其转换成类似地表示为存储器、寄存器或其他此类信息存储装置、传送装置或显示装置内的物理量的其他数据。
值得注意的是,一些方面可使用表达“联接”和“连接”以及它们的衍生词来描述。并不希望这些术语彼此同义。例如,一些方面可使用术语“连接”和/或“联接”来描述,以表示两个或更多个元件彼此直接物理接触或电接触。然而,术语“耦合”还可以指两个或更多个元件彼此不是直接接触,而是彼此配合或相互作用。就软件元件而言,例如,术语“联接”可指接口、消息接口、API、交换消息等。
应当理解,所述以引用的方式并入本文中的任何专利、出版物或其他公开材料,无论是全文或部分,仅在所并入的材料与本公开中给出的定义、陈述或者其他公开材料不冲突的范围内并入本文。同样地并且在必要的程度下,本文明确阐述的公开内容取代以引用方式并入本文的任何冲突材料。据称以引用方式并入本文但与本文列出的现有定义、陈述或其他公开材料相冲突的任何材料或其部分,将仅在所并入的材料和现有的公开材料之间不产生冲突的程度下并入。
本公开适用于常规的内窥镜检查和开放式外科器械以及机器人辅助的手术中的应用。
本文所公开的装置的各个方面可设计为使用单次后丢弃,也可设计为供多次使用。在上述任一或两种情况下,可对这些实施例进行修复,以便在使用至少一次后再使用。修复可包括以下步骤的任意组合:拆卸装置、然后清洗或更换特定零件和随后进行重新装配。具体地讲,可拆卸装置的实施例,并且可选择性地以任何组合形式来更换或移除装置的任意数量的特定零件或部件。在清洁和/或更换特定部件时,所述装置的实施例可在修复设施中重新组装或在即将进行手术前由手术团队重新组装以供随后使用。本领域的技术人员将会了解,装置的修复可以利用多种技术用于拆卸、清洁/替换以及重新组装。此类技术的使用和所得修复装置全部在本申请的范围内。
仅以举例的方式,可在外科手术之前对本文所述的方面进行处理。首先,可以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,将器械放置在闭合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该容器的辐射场,例如γ辐射、X射线或高能电子。辐射可以杀死器械上和容器中的细菌。消毒后的器械随后可被存放在无菌容器中。密封容器可将器械保持处于无菌状态,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或γ辐射、环氧乙烷、等离子体过氧化物或蒸汽。
本领域技术人员将会认识到,本文所述的组成部分(例如,操作)、装置、对象和它们随附的论述是为了概念清楚起见而用作示例,并且可以设想多种构型修改形式。因此,如本文所用,阐述的具体示例和随附的论述旨在代表它们更一般的类别。通常,任何具体示例的使用旨在代表其类别,并且具体组成部分(例如,操作)、装置和对象的未纳入部分不应采取限制。
对于本文中使用的基本上任何复数和/或单数术语,本领域技术人员可从复数转换成单数和/或从单数转换成复数,只要适合于上下文和/或应用即可。为清楚起见,各种单数/复数置换在本文中没有明确表述。
本文所述的主题有时阐述了包含在其他不同部件中的不同部件或与其他不同部件连接的不同部件。应当理解,这样描述的架构仅是示例,并且事实上可以实施实现获得相同功能性的许多其他架构。在概念意义上,获得相同功能性的组件的任何构造都是有效“相联的”,从而获得所需的功能性。因此,本文中为获得特定功能性而结合在一起的任何两个组件都可被视为彼此“相联”,从而获得所需的功能性,而不论结构或中间组件如何。同样,如此相联的任何两个组件也可被视为彼此“可操作地连接”或“可操作地联接”,以获得所需的功能性,并且能够如此相联的任何两个组件都可被视为彼此“能够可操作地联接”,以获得所需的功能性。可操作地联接的具体示例包括但不限于可物理匹配的和/或物理交互组件,和/或无线交互式,和/或无线交互式组件,和/或逻辑交互式,和/或逻辑交互式组件。
一些方面可以使用表达“联接”和“连接”以及它们的衍生词来描述。应当理解,并不希望这些术语是彼此同义的。例如,某些方面可以利用术语“连接”来描述,以表示两个或更多个元件彼此直接物理接触或电接触。在另一个示例中,一些方面可使用术语“联接”来描述,以表示两个或更多个元件直接物理接触或电接触。然而,术语“耦合”还可以指两个或更多个元件彼此不是直接接触,而是彼此配合或相互作用。
在一些情况下,一个或多个部件在本文中可被称为“被构造成能够”、“可被构造成能够”、“可操作/可操作地”、“适合/适于”、“能够”、“适应/适合”等。本领域的技术人员将会认识到,除非上下文另有所指,否则“被构造成能够”通常可涵盖活动状态的部件和/或未活动状态的部件和/或待机状态的部件。
虽然已经示出并描述了本文所述的本发明主题的特定方面,但是对本领域的技术人员将显而易见的是,基于本文的教导,可在不脱离本文所述的主题的情况下作出改变和变型,并且如在本文所述的主题的真实范围内,其更广泛的方面并因此所附权利要求将所有此类改变和变型包括在其范围内。本领域的技术人员应当理解,一般而言,本文、以及特别是所附权利要求(例如,所附权利要求的正文)中所使用的术语通常旨在为“开放”术语(例如,术语“包括”应解释为“包括但不限于”,术语“具有”应解释为“至少具有”,术语“包含”应解释为“包含但不限于”等)。本领域的技术人员还应当理解,当所引入权利要求表述的具体数目为预期数目时,则这样的意图将在权利要求中明确表述,并且在不存在这样的表述的情况下,不存在这样的意图。例如,为有助于理解,下述所附权利要求可含有对介绍性短语“至少一个”和“一个或多个”的使用以引入权利要求。然而,对此类短语的使用不应视为暗示通过不定冠词“一个”或“一种”引入权利要求表述将含有此类引入权利要求表述的任何特定权利要求限制在含有仅一个这样的表述的权利要求中,甚至当同一权利要求包括介绍性短语“一个或多个”或“至少一个”和诸如“一个”或“一种”(例如,“一个”和/或“一种”通常应解释为意指“至少一个”或“一个或多个”)的不定冠词时;这也适用于对用于引入权利要求表述的定冠词的使用。
另外,即使在明确叙述引入权利要求叙述的特定数目时,本领域的技术人员应当认识到,这种叙述通常应解释为意指至少所叙述的数目(例如,在没有其他修饰语的情况下,对“两个叙述”的裸叙述通常意指至少两个叙述、或两个或更多个叙述)。此外,在其中使用类似于“A、B和C中的至少一者等”的惯例的那些情况下,一般而言,这种结构意在具有本领域的技术人员将理解所述惯例的意义(例如,“具有A、B和C中的至少一者的系统”将包括但不限于具有仅A、仅B、仅C、A和B一起、A和C一起、B和C一起和/或A、B和C一起等的系统)。在其中使用类似于“A、B或C中的至少一者等”的惯例的那些情况下,一般而言,这种结构意在具有本领域的技术人员将理解所述惯例的意义(例如,“具有A、B或C中的至少一者的系统”将包括但不限于具有仅A、仅B、仅C、A和B一起、A和C一起、B和C一起和/或A、B和C一起等的系统)。本领域的技术人员还应当理解,通常,除非上下文另有指示,否则无论在具体实施方式、权利要求或附图中呈现两个或更多个替代术语的转折性词语和/或短语应理解为涵盖包括所述术语中的一者、所述术语中的任一个或这两个术语的可能性。例如,短语“A或B”通常将被理解为包括“A”或“B”或“A和B”的可能性。
对于所附的权利要求,本领域的技术人员将会理解,其中表述的操作通常可以任何顺序进行。另外,尽管以一定顺序列出了多个操作流程,但应当理解,可以不同于所示顺序的其他顺序进行所述多个操作,或者可以同时进行所述多个操作。除非上下文另有规定,否则此类替代排序的示例可包括重叠、交错、中断、重新排序、增量、预备、补充、同时、反向,或其他改变的排序。此外,除非上下文另有规定,否则像“响应于”、“相关”这样的术语或其他过去式的形容词通常不旨在排除此类变体。
概括地说,已经描述了由采用本文所述的概念产生的许多有益效果。为了举例说明和描述的目的,已提供了上述公开内容。所述说明并非意图为详尽的或限定到本发明所公开的精确形式。可以按照上述教导内容对本发明进行修改或变型。所选择和描述的一个或多个实施例是为了示出本发明的原理和实际应用,从而使得本领域的普通技术人员能够利用多个实施方案,在适合设想的具体应用的情况下进行各种修改。与此一同提交的权利要求书旨在限定完整范围。

Claims (18)

1.一种组织压缩传感器系统,包括:
RF电极,所述RF电极定位在端部执行器上;
第一电触点,所述第一电触点定位在所述端部执行器的砧座或通道框架中的一者上;和
第一滤波器,所述第一滤波器以能够通信的方式联接到所述第一电触点。
2.根据权利要求1所述的组织压缩传感器系统,还包括:
第二电触点,所述第二电触点定位在所述端部执行器的砧座或通道框架中的一者上;和
第二滤波器,所述第二滤波器以能够通信的方式联接到所述第二电触点。
3.根据权利要求2所述的组织压缩传感器系统,还包括:
多路复用器,所述多路复用器被构造成能够将两个或更多个RF信号传输到所述端部执行器。
4.根据权利要求2所述的压缩传感器系统,其中所述第一电触点和第二电触点通向公共返回路径。
5.根据权利要求3所述的组织压缩传感器系统,其中所述RF信号沿着所述端部执行器的单个功率侧传输。
6.根据权利要求2所述的组织压缩传感器系统,还包括:
阻抗计算器,所述阻抗计算器与所述第一滤波器和第二滤波器连通。
7.根据权利要求3所述的组织压缩传感器系统,还包括:
频率发生器,所述频率发生器被构造成能够生成所述两个或更多个RF信号。
8.根据权利要求1所述的组织压缩传感器系统,其中所述RF电极定位在所述端部执行器的钉仓上。
9.根据权利要求1所述的组织压缩传感器系统,还包括:
多个RF电极,所述多个RF电极定位在所述端部执行器上的离散点处。
10.根据权利要求1所述的组织压缩传感器系统,还包括:
多个RF电极,所述多个RF电极定位在所述端部执行器上的多个区域中。
11.一种用于感测组织压缩的方法,所述方法包括:
叠加两个或更多个RF信号并将所述RF信号传输到端部执行器;
使所述两个或更多个RF信号经由所述端部执行器的砧座或通道框架中的至少一者上的电触点返回到公共路径上;并且
在所述RF信号接入到所述公共路径上之前对所述两个或更多个RF信号进行滤波。
12.根据权利要求11所述的方法,还包括:
基于所述两个或更多个RF信号中的至少一者计算与由所述端部执行器压缩的组织相关联的阻抗。
13.根据权利要求11所述的方法,其中所述两个或更多个RF信号经由多路复用器被叠加。
14.根据权利要求11所述的方法,其中所述两个或更多个RF信号由所述端部执行器外部的频率发生器生成。
15.根据权利要求12所述的方法,其中基于所述RF信号中的一者计算垂直组织压缩并且基于所述RF信号中的另一者计算侧向组织压缩。
16.根据权利要求12所述的方法,其中基于所述RF信号中的一者计算近侧组织压缩并且基于所述RF信号中的另一者计算远侧组织压缩。
17.根据权利要求11所述的方法,其中两个或更多个滤波器用于在所述两个或更多个RF信号接入到所述公共返回路径之前对所述两个或更多个RF信号进行滤波,以区分由所述两个或更多个RF信号表示的单独组织阻抗。
18.根据权利要求14所述的方法,其中所述频率发生器位于内镜切割器的轴或柄部的电路板上。
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