CN107979988A - 用以修改加电外科器械的操作的多级阈值 - Google Patents
用以修改加电外科器械的操作的多级阈值 Download PDFInfo
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00115—Electrical control of surgical instruments with audible or visual output
- A61B2017/00119—Electrical control of surgical instruments with audible or visual output alarm; indicating an abnormal situation
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
- A61B2017/00398—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
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- A61B2018/00636—Sensing and controlling the application of energy
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- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0803—Counting the number of times an instrument is used
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/70—Cleaning devices specially adapted for surgical instruments
- A61B2090/702—Devices for testing the cleaning process, e.g. test soils
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- A61B2560/02—Operational features
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Abstract
本发明公开了可对于与外科装置的操作相关的一个或多个参数分配阈值。如果达到或预计达到极限阈值,则所述极限阈值可触发期望的动作,包括操作的停止或操作的修改。此外,边缘阈值可触发期望的动作,包括改进操作诸如减缓操作,其中参数的所述值被测量为在由边缘阈值和极限阈值限定的值之间。可基于多个参数来限定多个阈值,从而进一步实现校准使用,诸如根据超过基于消毒循环数量的边缘阈值以及超过基于电流消耗超过一定值的程度的边缘阈值两者来减缓操作。
Description
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实现这些特征和优点的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,并且其击发触发器也处于致动位置;
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-图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示出了功率段的一个方面,该功率段包括多个菊花链式功率转换器;
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顺序地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段的分段电路的一个方面;
图28为图1的外科器械的电路图,其被分成图28A和图28B;
图29为图1的外科器械的框图,其示出柄部组件14和功率组件之间、以及柄部组件14和可互换轴组件之间的接口;
图30示出了利用阈值来修改外科器械的操作的过程的一个方面;
图31示出示例性曲线图,其示出外科器械的操作的修改,描述线性函数;
图32示出示例性曲线图,其示出外科器械的操作的修改,描述非线性函数;
图33示出示例性曲线图,其示出基于预期用户输入参数对外科器械的操作的修改;
图34示出示例性曲线图,其示出基于阈值的检测对驱动器的速度的修改;
图35示出示例性曲线图,其示出基于阈值的检测基于电池电流与操作相关的修改;
图36示出示例性曲线图,其示出基于阈值的检测基于电池电压与操作相关的修改;
图37示出示例性曲线图,其示出基于循环阈值的检测对刀速度的修改;
图38示出了根据各个方面的用于评估外科器械的切割刃的锐度的系统的逻辑图;
图39示出了根据各个方面的用于确定在各种锐度水平下由锐度测试构件抵靠外科器械的切割刃施加的力的系统的逻辑图;
图40示出根据各个方面的用于确定外科器械的切割刃是否足够锐利以横切由外科器械捕获的组织的方法的流程图;
图41示出了根据各种实施方案的在各种锐度水平下由锐度测试构件抵靠外科器械的切割刃施加的力的图;
图42示出了流程图,其列出了根据各种实施方案的用于确定外科器械的切割刃是否足够锐利以横切由外科器械捕获的组织的方法。
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“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“OVERLAID MULTI SENSOR RADIO FREQUENCY(RF)ELECTRODE SYSTEM TOMEASURE TISSUE COMPRESSION”的美国专利申请序列号__________(代理人案卷号END7562USNP/140487);
-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);以及
-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提交于2015年2月27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“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;以及
-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提交于2014年12月18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“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提交于2013年3月14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 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提交于2014年3月26日的以下专利申请,并且其中每一个各自全文以引用的方式并入本文:
-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提交于2014年4月9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“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提交于2013年4月16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“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结构、功能、制造的原理、装置的用途和方法的全面理解。这些方面的一个或多个示例在附图中示出。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示例。结合一个示例进行图解说明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“在各个方面中”、“在一些方面中”、“在一个方面中”或“在方面中”等并不一定均指相同的方面。此外,具体特征、结构或特性可在一个或多个方面中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、结构或特性进行组合。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,而术语“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操作。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。
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。在所示示例中,器械10包括外壳12,该外壳包括被构造成能够由临床医生抓握、操纵并致动的柄部组件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手术。继续参阅本具体实施方式,将会理解,本文所公开的各种形式的可互换轴组件的各种独特和新颖的布局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,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,所述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,这些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,所述其他可互换轴组件包括被构造成能够将其他运动和能量形式(诸如,射频(RF)能量、超声能量和/或运动)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示出了可互换轴组件200到外壳12或柄部组件14的附接。如图4所示,柄部组件14可以包括一对可互连的柄部外壳段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。在所示布局中,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的,柄部组件14在其中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运动施加到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枢转地联接到外壳14。此类布局使闭合触发器32能够被临床医生操纵,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可轻松地从起始或“未致动”位置枢转到“致动”位置,并且更具体地讲,枢转到完全压缩或完全致动的位置。闭合触发器32可被弹簧或其他偏置结构(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爪64的释放按钮组件62。释放按钮组件62可由释放弹簧(未示出)沿逆时针方向枢转。临床医生将闭合触发器32从其未致动位置朝向柄部组件14的手枪式握把部19按压时,第一闭合连杆36向上枢转至某个点,其中锁定爪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结构。
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的打开或未夹持构型相关联,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)和第二位置(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。在至少一个方面中,例如,磁场传感器65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,还是/或者第一位置和第二位置之间的任何位置,所述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,所述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。
如在本公开中通篇使用,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能够可操作地支撑在本文中被称为击发驱动系统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在本文中也可称作“第二驱动系统”。击发驱动系统80可以采用位于柄部组件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可以是直流有刷驱动马达,其具有大约例如25,000RPM的最大转速。在其他布局中,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可由功率源90供电,在一种形式中,该功率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可各自包括例如锂离子(“LI”)电池或其他合适的电池。远侧外壳部分96被构造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的功率源。此外,功率源90可以是可更换的和/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,功率源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,该开关可被构造成能够使功率源90施加给电动马达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/或其中驱动构件120移动的方向。
马达82的致动可通过被可枢转地支撑在柄部组件14上的击发触发器130进行控制。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或其他偏置结构偏置到未致动位置,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或偏置结构枢转到或以其他方式返回未致动位置。在至少一种形式中,击发触发器130可以定位在闭合触发器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被容纳在柄部部件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致动的安全位置和其中击发触发器130可被击发的击发位置之间移动。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,其中临床医生可随后操纵该安全按钮和击发触发器。
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,而击发触发器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,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,诸如第一磁场传感器803和第二磁场传感器804,例如,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可在邻近第一磁场传感器803的第一位置和邻近第二磁场传感器804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”做棘轮运动。美国专利申请公布US 2010/0089970(现为美国专利8,608,045)公开了应急布局和也可与本文所公开的各种器械一起使用的其他部件、布局和系统。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(现为美国专利8,608,045)据此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可释放地将端部执行器300相对于轴轴线SA-SA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)的完整公开内容据此以引用方式并入本文。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)。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。在一种布局中,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被构造成能够被支撑在底座240内的脊轴承216。参见图7。此类布局有利于将脊210可旋转地附接到底座240,使得脊210可以相对于底座240选择性地围绕轴轴线SA-SA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。此类布局用来将闭合管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,用来沿近侧方向“PD”偏置闭合管260,当轴组件可操作地联接到柄部组件14时,该闭合弹簧可用来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,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)中所述的各种方式接合砧座306上的开口插片,该专利申请以引用方式并入本文。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,并因此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,使得插片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选择性地将端部执行器300锁定在适当的位置。当关节运动锁350处于其解锁状态时,此类布局使端部执行器300能够相对于轴闭合管260旋转或做关节运动。在此类解锁状态下,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/或骨来定位和推压,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做关节运动。
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包括被构造成用于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)。
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选择性地和可释放地将关节运动驱动器230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可在接合位置和脱离位置之间旋转,在所述接合位置,锁定套管402将关节运动驱动器360联接到击发构件220,在所述脱离位置,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,并且相应地,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呈圆柱形的主体,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-图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,以用于将向外突起的致动销410接纳在其中。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,有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以座置在轴脊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在其接合位置和脱离位置之间旋转。因此,喷嘴201本质上可用于按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各种方式,将关节运动驱动系统与击发驱动系统可操作地接合和脱离。
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,并且/或者将信号传送至端部执行器300和/或从该端部执行器接收信号。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,并且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),其中每个触点对应于导体602中的一个导体并与其电接触。此类布局在保持近侧连接器凸缘604和远侧连接器凸缘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,该电连接器可使导体602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和轴电路板610之间延伸。电连接器606可朝近侧延伸穿过限定在底盘安装凸缘242中的连接器开口243。参见图7。提交于2013年3月13日的名称为“STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM”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)以引用方式全文并入本文中。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(现为美国专利申请公布2014/0263551)以引用方式全文并入本文中。关于滑环组件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)。
如上文所讨论,轴组件200可包括可固定地安装到柄部14的近侧部分,以及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在第一位置和第二位置之间旋转。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不使轴组件200的端部执行器300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,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。基于来自磁场传感器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,所述燕尾形狭槽在框架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,从而以座置方式将附接部分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,例如如图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盘240的锁定构件或锁定轭712。在示出的示例中,例如,锁定轭712为U形,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。此类布局有利于将锁定轭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用于与框架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盘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保持座置在远侧附接凸缘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不经意地从外壳脱离。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成期望的位置。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以用于切割与缝合。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,可能期望的是防止轴组件200从外壳12意外脱离。闩锁系统710的一种形式被构造成能够防止此类不经意的脱离。
如可在图7中最具体所见,锁定轭712包括至少一个且优选地两个锁定钩718,所述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-图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不经意地以原本可能引起其朝远侧枢转的方式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描述可互换轴组件200到柄部组件14的附接。要开始联接过程,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上方或附近,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。然后临床医生可沿着垂直于轴轴线SA-SA的安装轴线IA运动轴组件200,以使附接部分244座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也将座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的部分将座置在闭合轭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”是指所述两个部件彼此充分地接合,使得一旦向其施加致动动作,所述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。第三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,该电气系统可发送例如轴组件(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(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。第五系统可由用于可释放地将轴组件200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中的一个或多个可与微控制器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中的一个或多个可与微控制器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中的一个或多个触点可意外地布置成彼此电连通。例如,当触点1401a-1401f中的一个或多个触点接触导电材料时,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(诸如轴组件200)未附接到柄部组件14时,柄部组件14可以不加电。
在其他情况下,当轴组件(诸如轴组件200)未附接到柄部1042时,柄部1042可被加电。在此类情况下,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。即使在此类情况下微控制器1500可提供有用于操作柄部组件14的其他功能的功率,柄部组件14也可处于掉电状态。在某种程度上,电连接器1400可处于掉电状态,因为施加到电触点1401b-1401e的电压电位可能不影响柄部组件14的操作。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是处于加电还是掉电状态,第六触点1401f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结构(诸如晶体管1410)和/或开关可被构造成能够控制从柄部组件14内的电源1404(诸如电池90)例如到第一电触点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,并最终将来自功率源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,该霍尔效应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可由诸如电池之类的功率源1406供电,该功率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完全座置。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,如在本公开中通篇使用,任何合适的磁场传感器可用于检测轴组件是否已组装到柄部组件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”)和可操作地联接到该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,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/或分立的硬件元件、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)。分立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分立的和集成的电路元件或部件。
参见图19,微控制器1500可例如是可购自Texas Instruments的LM 4F230H5QR。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(最多至40MHZ)的片上存储器、用于使性能改善超过40MHz的预取缓冲器、32KB的单循环串行随机访问存储器(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未组装到或未完全组装到柄部组件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。此类布局可降低物体意外地接触触点1401a-1401f中的一个或多个触点的可能性。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中的一个或多个触点的可能性。参照图3所示的具体示例,轴触点1411a-1411f可包括凸触点。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,轴凸触点1401a-1401f可抵靠该平坦表面擦过或滑过,并且维持平坦表面和轴凸触点1401a-1401f之间的导电接合。在各种情况下,将轴组件200组装到柄部组件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组装到柄部组件14时,轴触点1411a-1411f抵靠柄部触点1401a-1401f滑动。在各种替代示例中,柄部触点1401a-1401f可包括凸触点,并且轴触点1411a-1411f可包括凹触点。在某些替代示例中,柄部触点1401a-1401f和轴触点1411a-1411f可具有任何合适的触点布置方式。
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。当轴组件未组装到、或只部分地组装到柄部时,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和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,将轴组件组装到柄部时,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,则在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,该门可包括倾斜表面,在门与柄部或轴接触时,该倾斜表面可有利于门沿确定方向的位移。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个膜。当将轴组件组装到柄部时,膜可能破裂。在至少一种情况下,连接器的凸触点可先刺透膜,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和激活状况之间转换。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,当轴组件尚未组装到柄部组件14时,微控制器1500例如可监控触点1401a-1401f,以确定触点1401a-1401f中的一个或多个触点是否可能已经短路。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中的每个触点,并评估在该触点中的每个触点处是否仅存在最小电阻。此类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,或者另选地去激活全部触点。此类操作状态可包括去激活状况。如上文所讨论,如果轴组件组装到柄部组件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。此类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此类电连通的连接件。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型横梁178的切割表面182切断所夹持的组织。
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。在此类情况下,当击发杆172向远侧运动以从钉仓304击发钉和/或切入砧座306和钉仓304之间捕获的组织时,E型横梁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-图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-图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被构造成能够控制加电外科器械,诸如例如图1-18A中所示的外科器械10。多个电路段2002a-2002g被构造成能够控制加电外科器械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,以控制加电外科器械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(诸如加电外科器械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。因为处理器具有内部存储器,所以是顺序数字逻辑的示例。处理器的操作对象是以二进制数字系统表示的数字和符号。
在一个方面中,主处理器2006可以是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,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Texas Instruments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,主处理器2006可以是例如可购自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(最多至40MHZ)的片上存储器、用于使性能改善超过40MHz的预取缓冲器、32KB的单循环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。
在一个方面中,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被构造成能够检测加电外科器械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、识别加电外科器械的取向,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。
在一个方面中,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的显示连接器2024。显示连接器2024通过一个或多个显示驱动器集成电路2026将主处理器2006联接到显示器2028。显示驱动器集成电路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。
在一些方面中,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PCBA 2031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10一体成型。在一些示例中,轴段2002e包括第二轴EEPROM 2038。第二轴EEPROM 2038包括对应于可与加电外科器械10交接的一个或多个轴2004和/或端部执行器2006的多个算法、例程、参数、和/或其他数据。
在一些方面中,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。
在一些方面中,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加电外科器械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,以用于测量马达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。
在一些方面中,分段电路2000包括功率段2002h(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中的一个或多个电路段。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,最高至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。
在一些方面中,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和马达段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。
在一些方面中,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,左侧开关通过左挠性连接器2072a联接到主处理器2006,该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。右侧开关通过右挠性连接器2072b联接到主处理器2006,该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。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。
在一些方面中,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中的一个或多个开关可组合成单个开关,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中的一个或多个开关可组合成单个多位置开关。
在一个方面中,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监视功能。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可以是单轴、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,该加速度不一定是坐标加速度(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。
在一个方面中,安全处理器2004被构造成能够相对于一个或多个电路段2002c-2002h(诸如马达段2002g)实现监视功能。就这一点来说,安全处理器2004采用监视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监测主处理器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-图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监视马达传感器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通信的第二马达传感器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。
在一些方面中,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指示值超出可接受范围时,分段电路2000阻止电路段2002c-2002h中至少一个电路段(诸如马达段2002g)的操作。例如,在图21A-图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,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,并且中断和/或阻止至少一个电路段2002c-2002h(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的激活信号联接到与门。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中的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可阻止马达段2002g的操作。
在一些方面中,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,在一个方面中,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。
在一些方面中,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监测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,例如,诸如阻止电路段中的至少一个电路段的操作、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。
在一个方面中,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,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2004,2006中的任一者存储的值和/或参数是正确的。
在一些方面中,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,其用于指示操作正常。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。同样地,主处理器2006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以预先确定的间隔发生通信。预先确定的间隔可以是常数,也可能是能够依据电路状态和/或外科器械10的操作而改变的。
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。例如,“使用”可包括任何合适的动作、条件和/或参数诸如,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%的可得自功率组件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保持在工作状态下。
处理器2104保持使用循环计数。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,例如,使用循环计数被提供给远程系统,诸如中央数据库。使用循环计数由通信模块2112传输到远程系统。例如,通信模块2112被构造成能够使用任何合适的通信媒介,诸如有线和/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功率源2114的一个或多个参数(例如,自功率源2114消耗的电流)的电路。功率源2114的一个或多个参数对应于可由外科器械2110执行的一个或多个操作,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。
仍然参见图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测功率组件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包括化学品暴露传感器。化学品暴露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,在消毒过程期间,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被构造成能够监测功率组件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循环和/或消毒循环。在一些情况下,使用循环电路2102监测功率组件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便增加使用循环计数。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,使用循环计数对应于功率组件2100的消毒。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便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,对应于开式电路的无穷大电阻),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。例如,当使用指示器2106检测到特定事件和/或需求诸如,外科器械2110的击发、对应于单次患者手术时间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。如上所论述,在一些情况下,使用指示器2106包括对应于单次患者手术时间的计时电路。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使用外科器械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信息。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。可以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,例如,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诸如,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,中央数据库保持着对应于外科器械2110的每一次使用的计数。例如,每次使用外科器械2110时,与外科器械2110相关联的条形码便可被扫描。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引发可逆闭锁件。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并释放闭锁件。
在一些方面中,分段电路2000被构造用于顺序地启动。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,诸如例如分段电路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通电2272。安全处理器2004执行错误自检2274。当检测到错误时2276a,安全处理器停止对分段电路2000供电并生成错误代码2278a。当未检测到错误时2276b,安全处理器2004开始对主处理器2006加电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顺序地加电2278b。主处理器2006对每个电路段进行供电及错误检查。当未检测到错误时,对下一个电路段通电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示出了功率段2302的一个方面,该功率段包括多个菊花链式功率转换器2314,2316,2318。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,以监测分段电路和/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诸如例如运动传感器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被构造成能够将该电压升高至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-图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。在示出的示例中,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,示例不限于本说明书的上下文中所述的一个或多个特定电压范围。
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,示例不限于本说明书的上下文中所述的一个或多个特定电压范围。
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消除了对专门用于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。当将分段电路2400转变到休眠模式时,并且/或者在需要将另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,示例不限于本说明书的上下文中所述的一个或多个特定电压范围。
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另外的电路部件。然而,示例不限于本说明书的上下文中所述的一个或多个特定电压范围。
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检测到诸如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(诸如例如位置编码器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。
在一些方面中,例如,一个或多个柄部控件诸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。
在一些方面中,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,以及/或者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。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,示例不限于本说明书的上下文中所述的一个或多个特定电压范围。
5V供电段2516被顺序地在升压段2518之后通电。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供电,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,示例不限于本说明书的上下文中所述的一个或多个特定电压范围。
在一个方面中,功率系统2500包括过压识别及消减电路。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段2602的分段电路2600的一个方面。单点控制段2602使分段电路2600的控制硬件与分段电路2600的功率节段(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)。功率节段包括例如马达、马达驱动器和/或多个马达MOSFET。单点控制段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与功率节段隔离。在一些示例中,可再充电电池2608联接到安全处理器和任一另外的支持硬件。使控制段2602与功率节段隔离允许控制段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,示例不限于本说明书的上下文中所述的一个或多个特定电压范围。
图28A和图28B示出控制电路3000的另一方面,该控制电路被构造成能够控制图1-图18A所示的加电外科器械10。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可以是直流有刷驱动马达,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FET 3019,如图28A和图28B所示。马达3014可由功率组件3006供电,该功率组件可被可释放地安装到柄部组件14。功率组件3006被构造成能够向外科器械10提供控制功率。功率组件3006可包括电池,该电池可包括串联连接的、可用作功率源为外科器械10供电的多个电池单元。在此类构型中,功率组件3006可被称为电池组。在某些情况下,功率组件3006的电池单元可以是可更换的和/或可充电的。在至少一个示例中,电池单元可以是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驱动可纵向移动的驱动构件,以使端部执行器300生效。例如,马达3014可被构造成能够驱动能够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/或推进切割构件来切割例如由端部执行器300捕获的组织。
如图28A和图28B所示,并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200联接到柄部组件14(图1)时,输送第一功率输出为马达3014供电,以用于推进切割构件,并且以便当可互换轴组件200联接到柄部组件14时,输送第二功率输出为马达3014供电,以用于推进切割构件。此类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这方面可以是有益的。
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和轴组件控制器3022之间传输此类通信信号。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可以是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。在一种情况下,外科器械10(图1-图4)可包括功率管理控制器3016,诸如例如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 ARM Cortex R4知名的TMS570和RM4x的安全微控制器平台。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可以是例如可购自Texas Instruments的LM4F230H5QR。在至少一个示例中,Texas Instruments LM4F230H5QR是ARM Cortex-M4F处理器内核包括最高达40MHz的256KB单循环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单循环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,并且电流感测电路3036可用于监视功率组件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,但可以理解,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/或块的形式描述以有利于说明,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-图4)可包括输出装置3042,该输出装置可包括一个或多个用于向用户提供感官反馈的装置。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,该显示器可包含在柄部组件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和轴组件控制器3022之间的通信可通过接口3024实现。
已经描述了外科器械10(图1-图4)和用于控制其操作的各种控制电路2000,3000,本公开现在转向外科器械10和控制电路2000(或3000)的各种具体构型。
在各个方面中,本公开提供了用于数据存储和使用的技术。在一个方面,数据存储和使用基于多级动作阈值。此类阈值包括上限和下限极限阈值,关闭马达或激活返回的极限阈值是电流、压力、击发负载,扭矩被超过,并且另选地,在极限内运行时,装置自动补偿马达的负载。
在一个方面,器械10(结合图1-图29描述)可被构造成能够监测上限和下限极限阈值,以将最小和最大闭合夹持负载维持在可接受的限度内。如果没有达到最小值,则器械10无法启动,或者如果它降低到低于最小值,则需要用户动作。如果夹持负载处于适当的水平,但在击发期间下降到最小值以下,则器械10可调整马达的速度或警告用户。如果在操作期间违反了最小限度,则单元可能发出击发可能不会如预期那样完整的警告。器械10也可被构造成能够监测电池电压何时下降到下限极限以下,剩余电池功率仅能够直接使装置返回到I形梁停放状态。砧座上的打开力可用于感测端部执行器中的阻塞。另选地,器械10可被构造成能够监测马达电流何时上升或相关速度何时下降,然后马达控制增加脉冲宽度或频率调制以保持速度恒定。
在另一方面中,器械10(图1)可被构造成能够检测电流消耗、压力、击发负载、扭矩的极限阈值,使得当超过这些阈值中的任何一个阈值时,器械10关闭马达或使得电马达将刀返回到预击发位置。可以采用小于极限阈值的次级阈值来改变马达控制程序以通过改变马达控制参数来适应条件的变化。边缘阈值可基于对另一个计数器或输入的成比例响应而被构造为阶跃函数或斜坡函数。例如,就消毒而言,在0-200次消毒循环之间没有变化,从201-400次消毒循环每次使用减缓马达1%,并且防止使用超过400次消毒循环。马达的速度也可根据组织间隙和电流消耗而变化。
存在可能影响加电的可重复使用的缝合器装置的理想功能的许多参数。这些参数中的大多数具有极限的最大和/或最小阈值,超出该阈值,装置不应被操作。然而,也存在可影响装置功能操作的边缘限制。来自多个参数的这些多重限制可能会对装置的操作程序提供叠加和累积的影响。
因此,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。
机电装置的有效性能取决于各种因素。一个是操作包络,即装置执行其预期功能的参数、条件和事件的范围。例如,对于由电流驱动的马达供电的装置,可能存在高于某一电流阈值的操作区域,其中装置的运行效率比期望的更低。换句话说,可能存在上限的“速度极限”,高于该极限,效率下降。此类上限阈值可具有防止实质性低效率或甚至装置劣化的值。
然而,可能存在操作范围内的阈值,其可能形成可利用以提高操作状态下的效率的区域。换句话讲,可能存在其中装置可在限定的操作包络(或子包络)内调整和执行得更好的区域。此类区域可以是边缘阈值和极限阈值之间的区域。此外,这些区域可包括“有效点(sweet spot)”或预先确定的可选范围或点。这些区域也可包括其中性能被认为是足够的大范围。
可以限定极限阈值,高于该阈值或低于该阈值,可以采取一个或多个动作(或避免采取动作),诸如停止装置。此外,可以限定一个或多个边缘阈值,高于该阈值或低于该阈值,可以采取一个或多个动作(或避免采取动作)。通过非限制性示例,可以设置边缘阈值以限定马达的电流消耗超过极限阈值的75%的地方。例如,超过边缘阈值可能导致装置开始以增加的速率减缓马达速度,因为它继续攀升到极限阈值。
可采用各种机构来执行由于超过阈值而进行的一个或多个调整。例如,该调整可反映阶跃函数。其也可反映斜坡函数。可使用其他函数。
在各个方面中,为了通过附加机构增强性能,可以限定重叠阈值。重叠阈值可包括由多个参数限定的一个或多个阈值。重叠阈值可导致一个或多个阈值是生成另外一个或多个阈值的输入。重叠阈值可以是预定义的或动态地生成的,诸如在运行时。当您的阈值由多个输入限定时,重叠阈值可能会生效。例如,在消毒循环的数量超过300(边缘阈值)但是未超过500(极限阈值)时,装置更缓慢地运行马达。然后在电流消耗超过其75%边缘阈值时,其加倍减缓,甚至更缓慢。
图30为公开了多级阈值系统的方面的逻辑图,其中阈值规则框架4000。可识别参数4010,此类参数表示数量、量、状态、事件或更多。例如,所识别的参数可包括电流、电压、组织压力、组织厚度、钳口闭合率、组织蠕变速率、击发负载、刀厚度、扭矩或电池使用中的一者或多者。可识别这些参数的一个或多个极限阈值4012。例如,可识别预先确定的电流消耗。仅作为一个示例,极限电流消耗阈值可被限定为所选电流幅值的100%。根据情况可存在上限极限阈值、下限极限阈值、多个下限或上限极限阈值,或限定极限阈值的范围。应当理解,可以这样的方式限定和/或校准“极限”阈值,以便基本上保持单一阈值,但是体现各种动作触发。可识别一个或多个边缘阈值4014。如果超过边缘阈值,马达控制程序可改变操作以适应变化。
可以在单个外科手术期间监测一个或多个阈值,其中阈值彼此独立,没有相互作用。此外,两个或更多个参数的阈值之间可能存在交互关联。例如,基于电流消耗的参数的边缘阈值可为极限阈值的75%。此外,结合基于消毒循环数量的参数,边缘阈值可设置在200次消毒循环处,并且极限阈值设置在400次消毒循环处。马达使用可以从0到199次循环正常进行,然后从200到399次循环减缓1%。在第400次循环时,马达使用可被防止。然而,应当理解,可能存在交互作用。换句话讲,因为马达速度由于超过消毒循环阈值而降低了1%,所以可以相应地调整电流消耗阈值。这种交互作用可导致马达运行得比单独考虑任一输入的情况更缓慢。
因此,一个阈值的值可以是到另一个阈值的值的输入,或者一个阈值可以完全独立于另一个阈值。在激活两个或更多个阈值的情况下,可以认为可能存在重叠阈值。因此,限定多个边界和极限的多个阈值可能对器械10(图1-图4)的操作具有叠加或累积影响。并且,多阈值操作场景中的一个阈值可与另一个阈值具有因果关系,或者可能不存在因果关系,并且阈值可彼此独立地存在。
此外,阈值可根据在手术期间经历的状况或其他状况而动态地设置和/或重置。换句话讲,在给定的外科手术之前,可将一个或多个模块预编程到器械10(图1-图4)中,或者根据需要上传。另外,可在外科手术期间动态地确定或上传阈值。
现在暂时转向图1,可为许多参数分配阈值。因此,在示例中,可基于端部执行器300的砧座306和钉仓304之间,或砧座306和第二钳口构件302之间的组织间隙来分配阈值,并且由此改变马达速度。此外,在示例中,基于电流的阈值可改变马达速度控制。另外,在各种示例中,极限阈值、边缘阈值和重叠阈值可结合闭合夹持负载来建立,以促成可接受的操作范围。此外,在各种示例中,在砧座306上的打开力可有助于检测阻塞。另外,在各种示例中,如果没有实现最小阈值,则可以防止系统启动,或者如果它降到最小值以下,则可能需要用户动作。
仍然参考图1,在各个方面中,可以确定夹持负载是否可接受,并且当夹持负载在击发期间下降到最小阈值以下时,可调整马达的速度并且/或者警告临床医生。在各种示例中,当在操作期间超过最小阈值时,器械10可能发出击发可能不会如预期那样完整的警告。此外,在各种示例中,可以分配阈值,其中如果电池电量降到阈值以下,则可以使用剩余的电池电量来使装置相对于I形梁返回到停放状态。
然而,即使在不超过阈值的操作期间也可参考阈值。因此,例如,在“极限内”运行时,器械10可补偿马达的负载。例如,如果电流上升或相关速度下降,则马达控制可增加脉冲宽度或频率调制,以帮助维持恒定速度。换句话讲,即使在“极限内”运行时,也可采取措施来改善和/或优化器械10的操作。
此外,在外科手术期间,阈值可被动态地修改,或者生成新的阈值。这可以在若干事件之后发生,所述事件包括调整器械10的操作。
现在转回图30,在各个方面中,识别一个或多个参数4010。另外,识别一个或多个给定参数的一个或多个极限阈值4012。此外,识别一个或多个给定参数的一个或多个边缘阈值4014。措施4010,4012和4014可以在手术之前、手术期间或这两种情况下完成。
获得一个或多个参数的测量4016。可以确定给定参数的测量是否超过参数的上限极限阈值或下限极限阈值4018。当答案为否时,可以确定给定参数的测量是否超过参数的上限边缘阈值或下限边缘阈值4020。当答案为否时,操作可继续4026。并且,可以再次获得给定参数的测量。
然而,当对给定参数的测量是否超过参数的上限极限阈值或下限极限阈值4018的答案为是时,可将控制传递到可调整操作的地方4022。可进行许多类型的调整。一个示例是改变马达速度。可以确定是否修改给定阈值和/或生成新阈值4024。这可在已调整操作4022之后发生。
在调整操作之后,可以确定是修改阈值还是生成新阈值。例如,初始设置为75%的边缘阈值可被设置为不同的值。此外,如果需要,可以生成相同参数上的新阈值,或新参数上的新阈值。
在确定是修改阈值还是生成新阈值时,控制可回传至步骤4016,在该步骤处获得一个或多个参数的测量。此外,控制可进行到识别4010参数。
然而,当对测量是否超过上限极限阈值或下限极限阈值的答案为否时,则可以确定测量何时超过上限边缘阈值或下限边缘阈值。当答案为是时,则可调整操作4022,并且控制如上进行。当答案为否时,可继续操作4026并且控制进行到测量一个或多个参数。
应当理解,步骤的顺序可改变,并且不限于图30中具体公开的顺序。作为仅一个示例,在获得一个或多个参数的测量4016之后,可以确定是否超过边缘阈值4020。此外,可以在流程中明确地识别和考虑重叠阈值。
图31是器械系统参数相对于时间的图形表示4100,在一个方面中,其示出可如何在达到阈值的情况下调整器械系统参数。时间(t)沿着水平(x)轴4102示出,并且器械系统参数沿着竖直(y)轴4104示出,边缘阈值4104和极限阈值4106。在图34所示的图形表示4100中,y轴参数4102是分配器械系统参数的阈值的参数,并且x轴4102表示时间。在器械10(图1-图4)的操作期间的某个时间处,如函数4110所证明,测量可指示达到边缘阈值4106。此时,可调整器械10(图1-图4)的操作。例如,当y轴4104参数是由马达消耗的电流时,可以某些方式对随后的电流消耗和极限电流施加函数。在一个示例中,函数可表示线性进程4112。在操作过程中的某个时间处,可达到极限阈值4108。此时,电流可中断4114。因此,可以经由线性函数来实现调整机制。观察操作调整的另外观点是可存在方波乘数变化。
图32是器械系统参数的图形表示4120,在另一个方面中,其示出可如何在达到阈值的情况下调整系统参数。时间(t)沿着水平(x)轴4122示出,并且器械操作的数量沿着竖直(y)轴4124示出,边缘阈值4126和极限阈值4128。此处,y轴4124参数是分配阈值的参数。在器械10(图1-图4)的操作期间的某个时间处,测量可指示在操作4130的过程期间达到边缘阈值4126。此时,可调整器械10的操作。例如,当y轴4124参数是由马达消耗的电流时,可对表示非线性进程4132的随后电流消耗进行限制。在此之后的某个时间处,可达到极限阈值4128。此时,电流可中断4134。因此,可以经由非线性函数4132以可变斜率来实现调整机制。观察操作调整的另外观点是存在指数乘数变化;此处,y轴4124参数越接近极限阈值4128,电流增加的速率减小。
图33是表示一个方面的图形表示4140,其中检测器械10(图1-图4)对临床医生输入(用户输入)的响应,然后进行修改。时间(t)沿着水平(x)轴4142示出,并且用户输入沿着竖直(y)轴4144表示。换句话讲,临床医生在执行手术时可促使器械10的响应,诸如按压闭合触发器32(图1),这可能例如导致马达操作4146。随着马达速度增加,可以达到或可以不达到阈值。然而,在此处由曲线4150和4152的发散点4148表示的某个点处,可以确定马达速度已达到实际水平或预测的将来水平,其是或将是次优的或在其他方面不期望的。此时,器械10可采用控制措施,诸如算法来适应或以其他方式修改输出,从而调节马达,而不是遵循实际或预期的速度曲线4150。在某个点处,可中断马达致动4154。换句话讲,器械10可采取实际或预期的y轴参数,并且确定此类实际或预期的测量过大,采用算法来修改这样的此类参数。换句话说,经测量的临床医生行为可包括一个或多个阈值的值。
图34是表示一个方面的器械系统参数的图形表示4160,其中器械10(图1-图4)检测是否达到边缘阈值4166或极限阈值4168,并相应地做出响应。时间(t)沿着水平(x)轴4162示出,并且器械系统参数沿着竖直(y)轴4164示出。例如,此处,竖直(y)轴4154参数可以是驱动器(诸如闭合驱动系统30(图1)或击发驱动系统80(图1))的速度。器械10可检查在操作4170过程期间是否达到边缘阈值4166速度。当达到边缘阈值4166时,可使用控制措施,诸如算法来适应或以其他方式修改速度4172。修改的速度4172可由线性或非线性函数给出。并且,在极限阈值处,可中断向马达的供电4174。
应当理解,图33可表示评估实际或预测值的情况,是否提供了明确阈值,图34是其中提供了阈值的图形表示。然而,可以理解,一个或多个阈值可以等价结果被隐含地给予图33,只要预先确定或动态确定的值可用作阈值的函数等价物,或与一个或多个阈值相关联的触发动作。可存在两个或更多个可用作此类阈值函数等价物的最高限度或最低限度值。
转向使用阈值的另一个示例,图35是电池电流相对于时间的图形表示4180,其中时间(t)沿着水平(x)轴4182示出,并且电池电流IBAT沿着竖直(y)轴4184示出。在一个示例中,电池电流IBAT 4184在不同操作条件下进行监测。随着马达速度增加,来自电池90(图4)的电流消耗4186增加。电流消耗可根据若干因素以非线性方式增加;然而,器械10(图1-图4)可将电流消耗解析为线性函数4188。线性函数可以基于(1)平均总电流,(2)基于根据过去和/或当前电流对未来电流的预测,(1)和(2)两者,或另一个函数。线性函数4188可以从理论上扩展到线性函数4190,其是与线性函数4188具有相同斜率的外推扩展。
一旦线性函数4188到达边缘阈值4192,器械10(图1-图4)便可采取动作来修改响应。此处,边缘阈值被给定为极限阈值4194的75%,其中极限阈值表示马达停滞;然而,应当理解,可基于多个因素进行边缘阈值或极限阈值的选择。换句话讲,边缘阈值4192可在时间“a”处达到4196。如果不进行调整,则预计在时间“b1”处将会发生马达停滞4198。然而,由于由器械10进行的调整,因此直到时间“b2”才将发生实际的马达停滞4200。可能完全不会发生停滞,因为更多的有刻度上升可能有助于防止此类事件。经由控制措施实现的函数4202可基于减缓马达或另一调整。其可以表现为阶跃函数、斜坡函数或另外的函数。
采用本文的阈值可以给临床医生更多的时间来进行反应和适应,维持器械的期望效率,并延长电池寿命。因此,利用阈值可提供与临床医生使用的容易度和器械本身的保护相关的多种益处。
转向另一方面,图36是显示沿着水平(x)轴4212的时间(t)和沿着竖直(y)轴4214的电池电压VBAT的电池电压的图形表示4210。在一个示例中,可以结合电池电压VBAT 4214来设置阈值。此处,边缘阈值4216可被设置为8.1V。另外,极限阈值4218可被设置为7.0V。在器械10(图1-图4)的操作过程期间,电压可随时间推移而降低。通过测量电压降低4220描述的曲线不一定是线性的。然而,器械10可将电压降低解析为线性函数4222。线性函数可以为基于(1)平均总电压,(2)基于根据过去和/或当前电压对未来电压的预测,基于(1)和(2)两者,或另一个函数。线性函数4222可以从理论上外推到线性函数4224,其具有与线性函数4222相同的斜率。
一旦线性函数4222到达边缘阈值4216,器械10便可采取动作来修改响应。边缘阈值4216在时间“a”处达到4226。如果不进行调整,则预计在时间“b1”处将会发生耗尽的电池状况4228。然而,由于由器械10(图1-图4)进行的调整,因此直到时间“b2”才将发生实际耗尽的电池状况4230。再次,可能的是这可能完全不会发生。可经由控制措施实现的函数4232可基于减缓马达或另一调整。其可以表现为阶跃函数、斜坡函数或另外的函数。
图37是刀速度相对于循环数量的图形表示4240,其中沿着水平(x)轴4242示出了循环,并且沿着竖直(y)轴4244示出了刀速度。如图37所示的示例中所示,可以采用阈值来基于循环数量调整刀280(图8)的速度。相关循环可以指由器械10(图1-图4)执行的击发量,由器械10执行的消毒循环,或其他测量事件。通过该阈值机制来管理器械操作的目的是使切口将会有效的可能性最大化,同时考虑到多次使用后刀280刃的潜在钝化。在该示例中,可以基于预期的速度对刀的击发进行初始化。然而,一旦基于循环数量达到边缘阈值4246,速度就可诸如以阶跃方式4250从速度4248降低到4252。因此,一旦超过边缘阈值4760,刀280就将以逐渐降低的速度击发。这将在给定数量的循环4246内发生,直到达到极限阈值4254。此时,刀速度将阶跃式下降4256甚至更多,或者当然,器械10可警示临床医生用刀切入可能是不期望的,并且可锁定击发。应当理解,一旦达到阈值4246,则函数4248显示采用阶跃函数,并且一旦达到阈值4246,则函数4258显示采用斜坡函数4260。可采用另外的函数。
另外,应当理解,图37中给出的阈值已在x轴4711上限定,而先前的图已在y轴4712上显示了阈值。还将理解,可以考虑附加的一个或多个轴,即z轴或另外的轴,其中可以考虑多个变量的相互关系。另外,来自第一参数的阈值可与来自第二参数的阈值一起考虑,并且一个阈值可包括到另一个阈值的输入,反之亦然。
当超过阈值时,可以通知临床医生。这可基于反馈系统。在某些情况下,反馈系统可包括例如一个或多个视觉反馈系统,诸如显示屏、背光源、和/或LED。在某些情况下,反馈系统可包括例如一个或多个听觉反馈系统,诸如扬声器和/或蜂鸣器。在某些情况下,反馈系统可包括例如一个或多个触觉反馈系统。在某些情况下,反馈系统可包括例如视觉反馈系统、听觉反馈系统、和/或触觉反馈系统的组合。此类反馈可用于警示或警告临床医生。
图38示出了根据各种示例的用于评估外科器械10(图1-图4)的切割刃182(图20)的锐度的系统4311的逻辑图。图38示出了根据各种示例的用于评估外科器械10的切割刃的锐度的锐度测试系统4311。在某些情况下,系统4311可通过测试切割刃182推进穿过锐度测试构件4302的能力来评估切割刃182的锐度。例如,系统4311可被构造成能够观测切割刃182完全横切和/或完全穿过锐度测试构件4302的至少预先确定的部分所需要的时间段。如果所观测的时间段超过预定义阈值,则模块4310可断定例如切割刃182的锐度已下降到低于可接受水平。
在一个方面,锐度测试构件4302可用于测试切割刃182(图20)的锐度。在某些情况下,锐度测试构件4302可例如附接到钉仓304(图1、图2和图20)的仓体194(图20)和/或与其形成一体。在某些情况下,锐度测试构件4302可设置在例如钉仓304的近侧部分中。在某些情况下,锐度测试构件4302可被设置在例如钉仓304的仓平台或仓体194上。
在某些情况下,负荷传感器4335可被构造成能够例如监测当切割刃182接合和/或接触锐度测试构件4302时施加到切割刃182(图20)的力(Fx)。读者将会知道,当切割刃182接合和/或接触锐度测试构件4302时由锐度测试构件4302施加到切割刃182的力(Fx)至少部分地取决于切割刃182的锐度。在某些情况下,切割刃182的锐度的降低可导致切割刃182切割或穿过锐度测试构件4302所需的力(Fx)增加。锐度测试构件4302的负荷传感器4335可用于测量施加到切割刃182的力(Fx),而切割刃182穿过锐度测试构件4302行进的预定义距离(D)可用于确定切割刃182的锐度。
在某些情况下,模块4311可包括微控制器4313(“控制器”),该微控制器可包括微处理器4315(“处理器”)和一个或多个计算机可读介质或存储单元4317(“存储器”)。在某些情况下,存储器4317可存储各种程序指令,所述各种程序指令在执行时可使得处理器4315执行本文所述的多个功能和/或计算。在某些情况下,存储器4317可联接到例如处理器4315。例如,电源4319可被构造成能够例如将功率供应给控制器4313。在某些情况下,电源4319可包括电池(或者“电池组”或“电源组”),诸如锂离子电池。在某些情况下,电池组可被构造成能够可释放地安装到柄部14。可将多个串联的电池单元用作电源4319。在某些情况下,例如,电源4319可为例如可更换的和/或可再充电的。
在某些情况下,例如,处理器4313可操作地联接到例如反馈系统和/或闭锁机构4123。
模块4311可包括一个或多个位置传感器。适合与本公开一起使用的示例位置传感器和定位系统在2013年3月14日提交的名称为“SENSOR ARRANGEMENTS FOR ABSOLUTEPOSITIONING SYSTEM FOR SURGICAL INSTRUMENTS”的美国专利申请序列13/803,210(现为美国专利申请公布2014/0263538)中有所描述,该专利申请的公开内容全文以引用方式并入本文。在某些情况下,模块4311可包括第一位置传感器4321和第二位置传感器4323。在某些情况下,第一位置传感器4321可用于检测例如锐度测试构件4302的近侧端部处的切割刃182(图20)的第一位置;并且第二位置传感器4323可用于检测例如锐度测试构件4302的远侧端部处的切割刃182的第二位置。
在某些情况下,位置传感器4321和4323可用于分别将第一位置信号和第二位置信号提供给微控制器4313。应当理解,位置信号可为模拟信号或数字值,这取决于微控制器4313与位置传感器4321和4323之间的接口。在一个示例中,微控制器4313和位置传感器4321和4323之间的接口可为标准串行外围设备接口(SPI),并且位置信号可为表示切割刃182的第一位置和第二位置的数字值,如上所述。
除上述之外,处理器4315可确定接收第一位置信号和接收第二位置信号之间的时间段。所确定的时间段可对应于切割刃182(图20)从例如锐度测试构件4302的近侧端部处的第一位置到例如锐度测试构件4302的远侧端部处的第二位置推进穿过锐度测试构件4302所需要的时间。在至少一个示例中,控制器4313可包括时间元件,该时间元件可在接收到第一位置信号时由处理器4315激活并且可在接收到第二位置信号时去激活。时间元件的激活和去激活之间的时间段可对应于例如切割刃182从第一位置推进到第二位置所需要的时间。时间元件可包括实时时钟、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。
在各种情况下,控制器4313可例如将切割刃182(图20)从第一位置推进到第二位置所需要的时间段与预定义阈值进行比较,以评价切割刃182的锐度是否已下降到低于可接受水平。在某些情况下,如果所测量的时间段超过预定义阈值例如1%、5%、10%、25%、50%、100%和/或多于100%,则控制器4313可断定切割刃182的锐度已下降到低于可接受水平。
图39示出了根据各个方面的用于确定在各种锐度水平下由锐度测试构件4302抵靠外科器械10(图1-图4)的切割刃施加的力的系统4340的逻辑图。参见图39,在各种情况下,电动马达4331可驱动击发杆172(图20)以例如在击发行程期间推进切割刃182(图20)和/或在返回行程期间回缩切割刃182。马达驱动器4333可控制电动马达4331;并且微控制器例如诸如,微控制器4313可与马达驱动器4333进行信号通信。当电动马达4331推进切割刃182时,微控制器4313可例如确定由电动马达4331消耗的电流。在此类情况下,推进切割刃182所需的力可对应于例如由电动马达4331消耗的电流。仍参见图39,外科器械10的微控制器4313可确定切割刃182的推进期间由电动马达4331消耗的电流是否增大,并且如果增大,则可计算电流的增量百分比。
在某些情况下,当切割刃182(图20)与锐度测试构件4302接触时,由电动马达4331所消耗的电流可因锐度测试构件4302对切割刃182的阻力而显著增大。例如,当切割刃182接合、穿过、和/或切穿锐度测试构件4302时,由电动马达4331所消耗的电流可显著增大。读者将会知道,锐度测试构件4302对切割刃182的阻力部分地取决于切割刃182的锐度;并且当切割刃182的锐度因重复使用而降低时,锐度测试构件4302对切割刃182的阻力将增加。因此,当切割刃与锐度测试构件4302接触时由电动马达4331所消耗的电流的增量百分比的值可例如随着切割刃182的锐度因重复使用造成的降低而增大。
在某些情况下,经确定的由电动马达4331所消耗的电流的增量百分比的值可为由电动马达4331所消耗的电流的最大检测增量百分比。在各种情况下,微控制器4313可将所确定的由电动马达4331所消耗的电流的增量百分比的值与由电动马达4331所消耗的电流的增量百分比的预定义阈值进行比较。如果所确定的值超过预定义阈值,则微控制器4313可断定例如切割刃182的锐度已下降到低于可接受水平。
在某些情况下,如图39所示,处理器4315可与例如反馈系统和/或闭锁机构连通。在某些情况下,如果所确定的由电动马达4331消耗的电流的增量百分比的值超过预定义阈值,则处理器4315可例如采用反馈系统警示用户。在某些情况下,如果所确定的由电动马达4331所消耗的电流的增量百分比的值超过预定义阈值,则处理器4315可例如采用闭锁机构来阻止切割刃182(图20)的推进。在某些情况下,系统4311可包括第一位置传感器4321和第二位置传感器4323。外科器械10(图1-图4)可包括负荷传感器4335。
在各种情况下,微控制器4313可利用算法确定由电动马达4331所消耗的电流的变化。例如,电流传感器可检测击发行程期间由电动马达4331所消耗的电流。电流传感器可连续检测由电动马达消耗的电流,并且/或者可间歇性地检测由电动马达消耗的电流。在各种情况下,算法可比较最新的电流读数与例如紧接进展的电流读数。除此之外或另选地,算法可比较时间段X内的样品读数X与此前的电流读数。例如,算法可比较样品读数与例如此前的时间段X(诸如紧接进展的时间段X)内的样品读数。在其他情况下,算法可计算由马达所消耗的电流趋势平均值。算法可计算时间段X期间消耗的平均电流(包括例如最新电流读数),并且可比较消耗的平均电流与例如在紧接进展的时间段X期间消耗的平均电流。
图40示出根据各个方面的用于确定外科器械10(图1-图4)的切割刃是否足够锐利以横切由外科器械10捕获的组织的方法的逻辑图4350。参见图40,逻辑图4350示出用于评估外科器械10的切割刃182(图20)的锐度的方法;并且在切割刃182的锐度下降到和/或低于例如警示阈值和/或高风险阈值的情况下,则列出各种响应。在各种情况下,例如,微控制器诸如,微控制器4313可被构造成能够实施图40所示的方法4350。在某些情况下,外科器械10可包括负荷传感器4335;如图38和图39所示,并且微控制器4313可与负荷传感器4335连通。在某些情况下,例如,负荷传感器4335可包括力传感器诸如,应变仪,所述力传感器可操作地联接到击发杆172。在某些情况下,微控制器4313可采用负荷传感器4335来监控当切割刃182在击发行程期间推进时施加到切割刃182的力(Fx)。
在各种情况下,方法4350开始于引发外科器械10(图1-图4)的击发4352。在引发外科器械10击发4352之前、期间和/或之后,系统通过监测力(Fx)来检查切割刃182的钝度4354。读者将会知道,当切割刃182接合和/或接触锐度测试构件4302时,力(Fx)由锐度测试构件4302施加到切割刃182,并且该力(Fx)可至少部分地取决于切割刃182的锐度。在某些情况下,切割刃182的锐度的降低可导致切割刃182切割或穿过锐度测试构件4302所需的力(Fx)增加。
系统感测由锐度测试构件4302施加到切割刃182(图20)的力(Fx)4356。当感测到的力(Fx)保持在警示阈值范围内时4356,显示器将不显示任何内容4358,并且外科器械10(图1-图4)的击发将继续进行4360。当感测到的力(Fx)超出警示阈值范围时4356,系统然后将确定力(Fx)是否超出高风险阈值范围4354。显示器将向外科器械10的使用者显示切割刃182变钝的警示4364。在该阶段处,使用者意识到切割刃182变钝,并且可能需要替换。当力(Fx)被感测为大于高风险阈值范围时4362,显示器显示指示施加到切割刃182的力(Fx)大于高风险阈值并且切割刃182钝化的警告4366。如果切割刃被确定为变钝,则击发闭锁系统可被接合。显示器可显示任选的显示序列,以允许外科器械10的使用者覆写击发闭锁系统4368并继续击发该外科器械10 4360。
在某些情况下,负荷传感器4335(图38、图39)可被构造成能够例如监测当切割刃182接合和/或接触锐度测试构件4302(图38、图39)时施加到切割刃182(图20)的力(Fx)。读者将会知道,当切割刃182接合和/或接触锐度测试构件4302时由锐度测试构件4302施加到切割刃182的力(Fx)至少部分地取决于切割刃182的锐度。在某些情况下,切割刃182的锐度的降低可导致切割刃182切割或穿过锐度测试构件4302所需的力(Fx)增加。例如,如图41用图形所示,曲线4336,4338和4342分别表示当切割刃182穿过三个相同的或至少基本上相同的锐度测试构件4302行进预定义距离(D)时施加到切割刃182的力(Fx)。曲线4336对应于切割刃182的第一锐度;曲线4338对应于切割刃182的第二锐度;并且曲线4342对应于切割刃182的第三锐度。第一锐度大于第二锐度,并且第二锐度大于第三锐度。
在某些情况下,微控制器4313(图38、图39)可将施加到切割刃182(图20)的监测力(Fx)的最大值与一个或多个预定义阈值进行比较。在某些情况下,如图41所示,预定义阈值可包括警示阈值(F1)和/或高风险阈值(F2)。在某些情况下,如图41的曲线4336所示,监测力(Fx)可例如小于警示阈值(F1)。在此类情况下,如图41所示,切割刃182的锐度处于良好水平并且微控制器4313可不采取任何动作来向用户警示切割刃182的状态或者可通知用户切割刃182的锐度在可接受范围之内。
在某些情况下,如图41的曲线4338所示,监测力(Fx)可例如大于警示阈值(F1)但小于高风险阈值(F2)。在此类情况下,如图40所示,切割刃182(图2)的锐度可钝化但仍在可接受水平之内。微控制器4313可不采取任何动作来向用户警示切割刃182的状态。另选地,微控制器4313(图38、图39)可通知用户切割刃182的锐度在可接受范围之内。另选地或除此之外,微控制器4313可确定或估计切割刃182的生命周期中剩余的切割周期数并且可因此警示用户。
在某些情况下,存储器4317(图38、图39)可包括数据库或表,该数据库或表使切割刃182(图20)的生命周期中剩余的切割周期数与监测力(Fx)的预先确定的值相关联。处理器4315(图38、图39)可例如访问存储器4317以确定切割刃182的生命周期中剩余的切割周期数,其对应于监测力(Fx)的具体测量值并且可向用户警示切割刃182的生命周期中剩余的切割周期数。
在某些情况下,如图41的曲线4342所示,监测力(Fx)可例如大于高风险阈值(F2)。在此类情况下,如图40所示,切割刃182的锐度可低于可接受水平。作为响应,例如,微控制器4313可采用反馈系统来警告用户切割刃182太钝而不能安全使用。在某些情况下,例如,微控制器4313可在检测到监控力(Fx)超过高风险阈值(F2)时采用闭锁机构来阻止切割刃182的推进。在某些情况下,微控制器4313例如可采用反馈系统来向用户提供指令以用于重设闭锁机构。
现在参见图42,示出了一种方法4370,该方法用于例如确定切割刃(诸如切割刃182(图20))是否足够锐利以用于横切由端部执行器300(图1)捕获的具有特定组织厚度的组织。在某些情况下,微控制器4313可被实施以例如执行图42所示的方法4370。如上所述,切割刃182的重复使用可钝化或降低切割刃182的锐度,由此可增加切割刃182横切所捕获组织所需的力。换句换讲,可例如通过切割刃182横切所捕获组织所需的力来限定切割刃182的锐度水平。读者将会知道,切割刃182横切所捕获组织所需的力还可依赖于所捕获组织的厚度。在某些情况下,例如,在相同的锐度水平下,所捕获组织的厚度越大,则切割刃182横切所捕获组织所需的力也越大。
在某些情况下,例如,切割刃182(图20)可足够锐利以横切具有第一厚度的所捕获组织,但可不足够锐利以横切具有大于第一厚度的第二厚度的所捕获组织。在某些情况下,例如,如果所捕获组织具有位于特定组织厚度范围内的组织厚度,则由切割刃182横切所捕获组织所需的力限定的切割刃182的锐度水平可足以横切所捕获组织。在某些情况下,存储器4317(图38、图39)可存储由端部执行器300捕获的组织的一个或多个预定义组织厚度范围;以及与预定义组织厚度范围相关联的预定义阈值力。在某些情况下,每个预定义阈值力可表示适于横切具有组织厚度(Tx)的所捕获组织的切割刃182的最小锐度水平,该组织厚度(Tx)由与预定义阈值力相关联的组织厚度范围涵盖。在某些情况下,当切割刃182横切具有组织厚度(Tx)的所捕获组织所需的力(Fx)超过例如与涵盖组织厚度(Tx)的预定义组织厚度范围相关联的预定义阈值力时,则切割刃182可不足够锐利以横切所捕获组织。
示于图42中的方法4370开始于夹持组织4372。一旦要横切的组织被夹持,则感测组织的厚度4374。在感测到组织厚度4374之后,可由使用者引发外科器械的击发4376。一旦外科器械开始击发,则感测到施加到切割刃182(图20)的力(Fx)4378。然后将力(Fx)和组织厚度(Tx)与预先确定的组织厚度范围和充分横切预先确定的组织厚度所需的力范围进行比较4380。例如,如果感测到的力(Fx)大于以对于所夹持的组织感测到的组织厚度(Tx)充分横切组织所需的预先确定的力范围,则显示器将向使用者显示切割刃182钝化的警示4386。当感测到的力(Fx)在以对于所夹持的组织感测到的组织厚度(Tx)充分横切组织所需的预先确定的力范围内时,显示器可不显示任何内容4382。在两种情况下,外科器械继续击发4384以横切组织。
现在将结合下文所述的各种示例和此类示例的组合来描述本公开。
1.一个示例提供了一种外科切割和缝合器械,其包括至少一个处理器和可操作地相关联的存储器,该器械被构造成能够:识别参数;识别参数的极限阈值的值;以及识别参数的边缘阈值的值。
2.另一个示例提供了示例1所述的器械,其中基于确定参数的测量值超过极限阈值的值来调整器械的操作。
3.另一个示例提供了示例1或2所述的器械,其中基于确定参数的测量值超过边缘阈值的值来调整器械的操作。
4.另一个示例提供了示例1、2或3所述的器械,其中基于确定参数值的预测变化率将产生超过极限阈值的所述值的值来计算参数值的修改变化率。
5.另一个示例提供了示例4所述的器械,其中基于参数的计算的修改变化率来调整器械的操作。
6.另一个示例提供了示例5所述的器械,其中调整是基于阶跃函数的。
7.另一个示例提供了示例5所述的器械,其中调整是基于斜坡函数的。
8.另一个示例提供了示例5所述的器械,其中所计算的变化率的值包括位于边缘阈值的值和极限阈值的值之间的一组值。
9.另一个示例提供了示例1-8中任一项所述的器械,其中边缘阈值的值为极限阈值的值的大约75%。
10.另一个示例提供了示例1-9中任一项所述的器械,其中参数包括由与器械相关联的电池消耗的电流。
11.另一个示例提供了示例1-10中任一项所述的器械,其中参数包括与器械相关联的电池的电压。
12.另一个示例提供了示例1-11中任一项所述的器械,其中参数包括由器械击发的刀的速度。
13.另一个示例提供了示例1-12中任一项的器械,其中参数包括与外科器械相关联的消毒循环的数量。
14.另一个示例提供了示例1-13中任一项所述的器械,其中参数包括在器械的操作期间临床医生的测量行为。
15.又一个示例提供了一种外科切割和缝合器械,其包括至少一个处理器和可操作地相关联的存储器,该外科器械被构造成能够:识别第一参数;识别第二参数;以及识别特定阈值,该特定阈值包括以下各项中的一者或多者:第一参数的极限阈值的值;第一参数的边缘阈值的值;第二参数的极限阈值的值;和第二参数的边缘阈值的值。
16.另一个示例提供了示例15所述的器械,进一步被构造成能够根据确定已经超过特定阈值来调整操作。
17.另一个示例提供了示例15或16所述的器械,进一步被构造成能够存储重叠阈值,该重叠阈值基于以下两方面之间的数学关系:一方面,第一极限阈值的值或第一边缘阈值的值,以及另一方面,第二极限阈值的值或第二边缘阈值的值。
18.另一个示例提供了示例15-17中任一项所述的器械,其中第一参数包括器械的马达的速度,并且第二参数包括器械的消毒循环的数量。
19.另一个示例提供了示例15-18中任一项所述的器械,其中第一参数包括由器械部署的刀的速度,并且第二参数是器械的消毒循环的数量。
20.另一个示例提供了示例15-19中任一项所述的器械,其中基于确定器械已经超过特定阈值的值来识别第三阈值。
根据各种示例,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)。此外,存储装置(具有操作逻辑)和通信接口与一个或多个处理器彼此联接。
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。处理器处理从一个或多个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处理器或多核处理器中的任一个。存储装置可包括被构造成能够存储操作逻辑的永久和临时(工作)拷贝的易失性和非易失性存储介质。
在各个方面中,操作逻辑可以被构造成能够执行初始处理,并且将数据传送到托管应用程序的计算机,以确定和生成指令。对于这些示例,操作逻辑可以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。在另选示例中,操作逻辑可以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。
在各个方面中,操作逻辑可以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。操作逻辑可包括一个或多个逻辑单元或模块。操作逻辑可以面向对象的方式来实施。操作逻辑可被构造成能够以多任务方式和/或多线程方式来执行。在其他示例中,操作逻辑可在诸如门阵列的硬件中实施。
在各个方面中,通信接口可以被构造成能够有利于外围设备和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。在各种示例中,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。
对于各种方面,处理器可与操作逻辑封装在一起。在各种示例中,处理器可与操作逻辑封装在一起以形成SiP。在各种示例中,处理器可在相同裸片上与操作逻辑一起集成。在各种示例中,处理器可与操作逻辑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,所述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且可由计算设备访问的任何可用介质。一些示例还可在分布式计算环境中实践,在所述分布式计算环境中,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/或模块可由例如待由逻辑设备(例如,处理器)执行的逻辑(例如,指令、数据、和/或代码)来实现。此类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。在其他示例中,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、代码段、计算机代码段、字、值、符号、或它们的任何组合。确定一个示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个或多个模块可包括实施为固件、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个或多个模块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。所述制造制品可以包括被布置为存储用于执行一个或多个示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。在各种示例中,例如,制造制品可包括磁盘、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,示例并不仅限于此。
结合本文所公开的示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、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且可由计算设备访问的任何可用介质。一些示例还可在分布式计算环境中实践,在所述分布式计算环境中,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,本文所述的方面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示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示例中的每个示例具有分立部件和特征,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“一个示例”或“示例”的提及均意指结合示例所述的特定特征、结构或特性包括在至少一个示例中。在说明书中各处出现的短语“在一个示例中”或“在一个方面”并不一定全部是指相同的示例。
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、分立门或晶体管逻辑、分立硬件部件,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。
本公开应用于常规的内窥镜检查和开放式外科器械以及应用于机器人辅助的手术。
本文所公开的装置的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,都可对这些示例进行修复,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,可拆卸装置的示例,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,所述装置的示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,此类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布局都是有效“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配合的和/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。
Claims (20)
1.一种外科切割和缝合器械,包括至少一个处理器和可操作地相关联的存储器,所述器械被构造成能够:
识别参数;
识别所述参数的极限阈值的值;以及
识别所述参数的边缘阈值的值。
2.根据权利要求1所述的器械,其中基于确定所述参数的测量值超过所述极限阈值的所述值来调整所述器械的操作。
3.根据权利要求1所述的器械,其中基于确定所述参数的测量值超过所述边缘阈值的所述值来调整所述器械的操作。
4.根据权利要求1所述的器械,其中基于确定所述参数的所述值的预测变化率将产生将超过所述极限阈值的所述值的值来计算所述参数的所述值的修改变化率。
5.根据权利要求4所述的器械,其中基于所述参数的计算的修改变化率来调整所述器械的操作。
6.根据权利要求5所述的器械,其中所述调整是基于阶跃函数的。
7.根据权利要求5所述的器械,其中所述调整是基于斜坡函数的。
8.根据权利要求5所述的器械,其中所述计算的变化率的所述值包括位于所述边缘阈值的所述值和所述极限阈值的所述值之间的一组值。
9.根据权利要求1所述的器械,其中所述边缘阈值的所述值为所述极限阈值的所述值的大约75%。
10.根据权利要求1所述的器械,其中所述参数包括由与所述器械相关联的电池消耗的电流。
11.根据权利要求1所述的器械,其中所述参数包括与所述器械相关联的电池的电压。
12.根据权利要求1所述的器械,其中所述参数包括由所述器械击发的刀的速度。
13.根据权利要求1所述的器械,其中所述参数包括与所述外科器械相关联的消毒循环的数量。
14.根据权利要求1所述的器械,其中所述参数包括在所述器械的操作期间临床医生的测量行为。
15.一种外科切割和缝合器械,包括至少一个处理器和可操作地相关联的存储器,所述外科器械被构造成能够:
识别第一参数;
识别第二参数;以及
识别特定阈值,所述特定阈值包括以下各项中的一者或多者:
所述第一参数的极限阈值的值;
所述第一参数的边缘阈值的值;
所述第二参数的极限阈值的值;和
所述第二参数的边缘阈值的值。
16.根据权利要求15所述的器械,进一步被构造成能够根据确定已经超过特定阈值来调整操作。
17.根据权利要求15所述的器械,进一步被构造成能够存储重叠阈值,所述重叠阈值基于以下两方面之间的数学关系:一方面,所述第一极限阈值的所述值或所述第一边缘阈值的所述值,以及另一方面,所述第二极限阈值的所述值或所述第二边缘阈值的所述值。
18.根据权利要求15所述的器械,其中所述第一参数包括所述器械的马达的速度,并且所述第二参数包括所述器械的消毒循环的数量。
19.根据权利要求15所述的器械,其中所述第一参数包括由所述器械部署的刀的速度,并且所述第二参数是所述器械的消毒循环的数量。
20.根据权利要求15所述的器械,其中基于确定所述器械已经超过特定阈值的值来识别第三阈值。
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PCT/US2016/020624 WO2016144682A1 (en) | 2015-03-06 | 2016-03-03 | Multiple level thresholds to modify operation of powered surgical instruments |
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2015
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2016
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- 2016-03-03 JP JP2017546798A patent/JP6707554B2/ja active Active
- 2016-03-03 BR BR112017019031-1A patent/BR112017019031B1/pt active IP Right Grant
- 2016-03-03 WO PCT/US2016/020624 patent/WO2016144682A1/en active Application Filing
- 2016-03-04 EP EP17199779.4A patent/EP3311761B1/en active Active
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2019
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BR112017019031B1 (pt) | 2022-09-13 |
CN107979988B (zh) | 2021-05-07 |
US20160256185A1 (en) | 2016-09-08 |
PL3064152T3 (pl) | 2018-03-30 |
EP3064152B1 (en) | 2017-11-08 |
BR112017019031A2 (pt) | 2018-04-17 |
US11944338B2 (en) | 2024-04-02 |
US20220218376A1 (en) | 2022-07-14 |
JP6707554B2 (ja) | 2020-06-10 |
US20200214731A1 (en) | 2020-07-09 |
US10441279B2 (en) | 2019-10-15 |
JP2018510695A (ja) | 2018-04-19 |
EP3311761A1 (en) | 2018-04-25 |
EP3311761B1 (en) | 2021-11-24 |
EP3064152A1 (en) | 2016-09-07 |
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