CN110996815B - 可重复使用的超声医疗装置及其使用方法 - Google Patents
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Abstract
本发明公开了用于管理可重复使用的超声医疗装置的多种方法,所述方法可包括:医疗装置控制模块能够从使用者组装或重新组装的超声医疗装置处接收功能数据,并且如果所述功能数据的值在可接受范围内则通知所述使用者。如果所述功能数据的所述值不在所述可接受范围内,则所述控制模块可以提示使用者重新组装所述装置或清洁或替换其一个或多个部件。所述功能数据可涉及钳口组件的夹持力、超声刀的阻抗或谐振频率值或所述装置的一个或多个移动部件的机械位移值。
Description
背景技术
超声外科装置因其独特的性能特性而用于外科规程的多种应用中。根据具体的装置构型和操作参数,超声外科装置可基本上同时提供组织的横切和通过凝结止血,从而有利地使患者创伤最小化。超声外科装置可包括包含超声换能器的手持件,以及联接到超声换能器的器械,该超声换能器具有安装在远侧的端部执行器(例如,刀片尖端和夹持臂)以切割并密封组织。在一些情况下,器械可永久性地附连到手持件。在其他情况下,如就可重复使用的器械或在不同手持件之间可互换的器械而言,该器械可从该手持件拆下。端部执行器将超声能量发射到与端部执行器接触的组织,以实现切割和密封动作。具有该性质的超声外科装置可被配置用于开放性外科用途、腹腔镜式或内窥镜式外科规程,包括机器人辅助的规程。
超声能量使用比用在电外科规程中的温度低的温度来切割和凝结组织。通过高频振动(例如,每秒55,500次),超声刀使组织中的蛋白质变性以形成粘性凝结物。刀片表面施加在组织上的压力使血管塌缩并使该凝固物形成止血密封。外科医生可通过由端部执行器施加到组织的力、施加该力的时间以及端部执行器的选定偏移水平来控制切割速度和凝结。
可以认识到,超声医疗装置的部分在使用期间可能被组织和其他医疗废物污染,并且因此该装置或该装置的部分在用于每个患者之前必须进行清洁和灭菌。此外,传递到超声医疗装置的部件的振动能量可导致部件磨损或故障,包括例如超声刀的破损。因此,随着时间的推移和使用,超声医疗装置的一些部件应当在这种可重复使用之前进行替换或修复。在某种程度上,该装置可拆卸,以便实现部件的清洁、替换或修复。
装置的清洁、修复或零件替换可由制造商或由制造商授权的第三方执行,但是此类过程可能会使装置在不可接受的时间内停止使用。因此,被构造用于由最终使用者进行清洁、修复或零件替换的超声医疗装置优于需要在分开的设施处维修的超声医疗装置。然而,还可认识到,最终使用者可能不具备确保重新组装的清洁、修复或翻新的医疗装置处于便于在重新组装后重复使用的可接受状态的技能。因此,希望在可重复使用的超声医疗装置内结合特征部以确保使用者在清洁、修复或零件替换之后能够成功地重新组装该装置。
发明内容
在一个方面,一种管理可重复使用的超声医疗装置的方法包括:由超声医疗装置控制模块接收来自由使用者重新组装的超声医疗装置的电连接;由超声医疗装置控制模块提示使用者操作钳口控制部件,该钳口控制部件被构造成能够闭合重新组装的超声医疗装置的端部执行器的钳口;由超声医疗装置控制模块接收来自设置在超声医疗装置内的闭合传感器的闭合数据,该闭合数据指示端部执行器的钳口处于闭合构型;由超声医疗装置控制模块接收来自超声医疗装置的功能数据,该功能数据参考重新组装的超声医疗装置的至少一个部件的功能状态;由超声医疗装置控制模块将功能数据的值与一个或多个预定的接受参考值进行比较;以及由超声医疗装置控制模块基于功能数据的值与一个或多个预定的接受参考值的比较,向使用者提供可接受性指示。
在该方法的一个方面,接收来自由使用者重新组装的超声医疗装置的电连接包括接收来自超声医疗装置的电连接,该超声医疗装置具有由使用者重新清洁或重新消毒的至少一个部件。
在该方法的一个方面,接收来自由使用者重新组装的超声医疗装置的电连接包括接收来自超声医疗装置的电连接,该超声医疗装置具有至少一个修复部件。
在该方法的一个方面,接收来自由使用者重新组装的超声医疗装置的电连接包括接收来自超声医疗装置的电连接,该超声医疗装置具有至少一个替换部件。
该方法的一个方面还包括:由超声医疗装置控制模块确定功能数据的值在接受范围内,并且基于功能数据的值与一个或多个预定的接受参考值的比较向使用者提供可接受性指示包括向使用者提供医疗用途的装置可接受性的指示。
该方法的一个方面还包括:由超声医疗装置控制模块确定功能数据的值不在接受范围内,并且基于功能数据的值与一个或多个预定的接受参考值的比较向使用者提供可接受性指示包括向使用者提供医疗用途的装置不可接受性的指示。
该方法的一个方面还包括:由超声医疗装置控制模块接收来自可编程存储器装置的一个或多个预定的接受参考值,该可编程存储器装置设置在重新组装的超声医疗装置内。
该方法的一个方面还包括:在重新组装的超声医疗装置的初始制造期间,利用一个或多个预定的接受参考值对可编程存储器装置进行编程。
在该方法的一个方面,接收来自超声医疗装置的功能数据包括:接收来自超声医疗装置的参考管状致动构件的位移值的功能数据,该管状致动构件被构造成能够致动重新组装的超声医疗装置的钳口。
在该方法的一个方面,接收来自超声医疗装置的参考管状致动构件的位移值的功能数据包括:接收来自霍尔效应传感器的数据,该霍尔效应传感器被配置成能够测量管状致动构件的位移值。
在该方法的一个方面,接收来自超声医疗装置的功能数据包括:接收来自超声医疗装置的参考弹簧堆叠的位移值的功能数据,该弹簧堆叠与构造成致动重新组装的超声医疗装置的钳口的管状致动构件机械连通。
在该方法的一个方面,接收来自超声医疗装置的参考弹簧堆叠的位移值的功能数据包括:接收来自霍尔效应传感器的数据,该霍尔效应传感器被配置成能够测量弹簧堆叠的位移值。
该方法的一个方面还包括:由超声医疗装置控制模块向声学地联接到超声波导的压电致动器提供电流;并且收来自超声医疗装置的功能数据包括:接收来自超声医疗装置的功能数据,该功能数据参考与超声波导相关联的阻抗。
在该方法的一个方面,基于功能数据的值与一个或多个预定的接受参考值的比较向使用者提供可接受性指示包括:提供了在重新组装的超声医疗装置中减振膜的存在的指示。
在该方法的一个方面,向声学地联接到超声波导的压电致动器提供电流包括向压电致动器提供电流,该压电致动器被构造成能够在超声波导中感应出横向机械波。
在该方法的一个方面,向声学地联接到超声波导的压电致动器提供电流包括向压电致动器提供电流,该压电致动器被构造成能够在超声波导中感应出非横向机械波。
在该方法的一个方面,向声学地联接到超声波导的压电致动器提供电流包括向声学地联接到超声波导的多个压电元件中的一个或多个提供电流,其中多个压电致动器中的一个或多个中的每个被构造成能够在超声波导中感应出非横向机械波。
在该方法的一个方面,基于功能数据的值与一个或多个预定的接受参考值的比较向使用者提供可接受性指示包括:提示使用者替换超声波导或替换声学地联接到超声波导的超声刀。
该方法的一个方面还包括:由超声医疗装置控制模块向声学地联接到超声波导的压电致动器提供电流;并且由超声医疗装置控制模块接收来自超声医疗装置的功能数据,该功能数据参考与声学地联接到超声波导的超声波导相关联的机械谐振频率。
在该方法的一个方面,向使用者提供可接受性指示包括提示使用者重新组装重新组装的超声医疗装置。
在该方法的一个方面,接收来自超声医疗装置的功能数据包括:接收来自超声医疗装置的参考垫的夹持力值的功能数据,该垫与超声医疗装置的钳口机械连通,该超声医疗装置的钳口抵靠重新组装的超声医疗装置的超声刀。
在该方法的一个方面,接收来自超声医疗装置的参考夹持力值的功能数据包括:接收来自压电力传感器的数据,该压电力传感器机械联接到致动构件驱动组件的部件,该致动构件驱动组件被构造成能够致动重新组装的超声医疗装置的钳口。
在该方法的一个方面,接收来自超声医疗装置的功能数据包括:接收来自超声医疗装置的参考远侧凸缘与近侧凸缘之间的距离的功能数据,该远侧凸缘与延伸管机械连通,并且该近侧凸缘与该延伸管机械连通,其中延伸管被构造成能够致动重新组装的超声医疗装置的钳口。
该方法的一个方面还包括:由超声医疗装置控制模块提示使用者启动包括烧机过程的预运行过程;由超声医疗装置控制模块在预定的时间段内激活预运行过程;并且由超声医疗装置控制模块根据闭合数据确定端部执行器的钳口在预定的时间段处于闭合构型,其中接收来自超声医疗装置的参考超声医疗装置的至少一个部件的功能状态的功能数据包括:接收在预定的时间段内参考超声刀的谐振频率的功能数据。
可重复使用的超声医疗装置的一个方面包括:柄部组件;细长轴组件,该细长轴组件机械联接到柄部组件,该细长轴组件内部远侧部分包覆有电绝缘材料,其中细长轴组件的近侧内部表面的至少一部分是导电的;第一电触点,该第一电触点电联接到细长轴组件的导电内部表面;导电波导,该导电波导设置在细长轴组件内;第二电触点,该第二电触点电联接到导电波导;导电超声刀,该导电超声刀声学地联接和电联接到波导,该导电超声刀的远侧部分涂覆有电绝缘涂层;发生器,该发生器被构造成能够将功率递送到声学地联接到波导的超声换能器;以及控制器模块,该控制器模块被配置成能够控制发生器。在可重复使用的超声医疗装置的该方面,控制器模块包括处理器和被构造成能够包含指令的存储器电路。在可重复使用的超声医疗装置的该方面,指令当由处理器执行时,使处理器在第一电触点与第二电触点之间施加电势,测量在第一电触点与第二电触点之间流动的电流,并且当电压值在公差范围之外时,通知可重复使用的超声医疗装置的使用者。
在超声医疗装置的一个方面,导电超声刀的远侧部分的电绝缘涂层具有近侧涂层边缘,该近侧涂层边缘位于电绝缘材料的远侧边缘的远侧,该电绝缘材料包覆在细长轴组件的内部远侧部分上。
管理可重复使用的超声医疗装置的方法的一个方面包括:由超声医疗装置控制模块接收来自由使用者重新组装的超声医疗装置的电连接;由超声医疗装置控制模块在电联接到导电波导的第一触点与电联接到细长轴组件的导电内表面的第二触点之间施加电势,其中波导设置在细长轴组件内的内部空间中;由超声医疗装置控制模块测量在第一触点与第二触点之间流动的电流;由超声医疗装置控制模块将电流值与接受范围的一个或多个值进行比较;并且由超声医疗装置控制模块基于电流的值与一个或多个预定的接受参考值的比较,向使用者提供可接受性指示。
该方法的一个方面还包括:由超声医疗装置控制模块确定电流的值在接受范围内,并且其中基于电流的值与一个或多个预定的接受参考值的比较向使用者提供可接受性指示包括向使用者提供医疗用途的装置可接受性的指示。
该方法的一个方面还包括:由超声医疗装置控制模块确定电流的值不在接受范围内,并且其中基于电流的值与一个或多个预定的接受参考值的比较向使用者提供可接受性指示包括向使用者提供医疗用途的装置不可接受性的指示。
该方法的一个方面还包括由超声医疗装置控制模块提示使用者清洁或重新消毒重新组装的超声医疗装置的部件。
可重复使用的超声医疗装置的另一个方面包括:柄部组件;细长轴组件,该细长轴组件在近侧端部机械联接到柄部组件;端部执行器组件,该端部执行器组件在细长轴组件的远侧端部机械联接;以及控制器模块。在该方面,柄部组件包括触发器组件;触发器传感器,该触发器传感器被配置成能够确定触发器组件的位置;轭,该轭机械联接到触发器组件;以及致动构件驱动组件。在该方面,致动构件驱动组件包括联接组件,该联接组件具有:具有远侧凸缘和近侧凸缘的管套环、设置在远侧凸缘与近侧凸缘之间的弹簧堆叠以及机械联接到弹簧堆叠的力传感器,其中联接组件被构造成能够在远侧凸缘与近侧凸缘之间接收轭。在该方面,细长轴组件包括:外部护套;管状致动构件,该管状致动构件设置在外部护套内,其中管状致动构件的近侧部分机械联接到致动构件驱动组件。在该方面,端部执行器组件包括超声刀和被构造成能够可释放地接合超声刀的钳口组件,其中钳口组件机械联接到管状致动构件的远侧端部。在该方面,控制器模块被配置成能够接收来自触发器传感器的触发器位置数据和来自力传感器的力数据。在该方面,可重复使用的超声医疗装置的一个或多个部件被构造成能够由医疗装置的使用者替换。
在可重复使用的超声医疗装置的该方面,力传感器包括压电盘。
在可重复使用的超声医疗装置的该方面,控制器模块包括处理器和被构造成能够包含指令的第一存储器电路。在该方面,指令当由处理器执行时,使处理器:确定设置在压电盘的第一侧上的第一触点与设置在压电盘的第二侧上的第二触点之间的电势值;基于该电势来计算力值;并且当力值在公差范围之外时,通知可重复使用的超声医疗装置的使用者。
在可重复使用的超声医疗装置的一个方面,柄部组件还包括可编程存储器电路,该可编程存储器电路被配置成能够包含与公差范围对应的存储值,并且控制器模块被配置成能够接收来自存储器电路的存储值。
在可重复使用的超声医疗装置的一个方面,柄部组件还包括可编程存储器电路,该可编程存储器电路被配置成能够包含电势/力标准化数据。此外,在该方面,由处理器执行以基于电势来计算力值的指令包括使处理器基于电势和电势/力标准化数据来计算力值的指令。
一个或多个具体实施的细节在以下附图和具体实施方式中示出。通过说明书、附图和权利要求书,其他特征和优点将显而易见。
附图说明
图1至图2描绘了根据本公开的一个方面的示例外科器械。
图3描绘了根据本公开的一个方面的外科器械的端部执行器和轴的示例。
图4描绘了根据本公开的一个方面的外科器械的一个方面的分解图。
图5描绘了根据本公开的超声医疗装置的一个方面的内部视图。
图6描绘了根据本公开的超声换能器的一个方面的视图。
图7描绘了根据本公开的具有相关联波导的超声换能器的另一个方面的透视图。
图8是图7所描绘的超声换能器的一部分的一个方面的放大透视图。
图9是根据本公开的具有多对压电换能器的超声医疗装置的一部分的一个方面的透视图。
图10A和图10B描绘了根据本公开的电感传感器的一个方面,该电感传感器被配置成能够检测超声医疗装置的往复式管部件的运动。
图11A和图11B描绘了根据本公开的磁性传感器的一个方面,该磁性传感器被配置成能够检测超声医疗装置的往复式管部件的运动。
图12A和图12B描绘了根据本公开的磁性传感器的一个方面,该磁性传感器被配置成能够检测超声医疗装置的往复式套环凸缘部件的运动。
图13A和图13B描绘了根据本公开的电阻传感器的一个方面,该电阻传感器被配置成能够检测超声医疗装置的往复式套环凸缘部件的运动。
图14A和图14B描绘了根据本公开的光学传感器的一个方面,该光学传感器被配置成能够检测超声医疗装置的往复式套环凸缘部件的运动。
图15A和图15B描绘了根据本公开的磁性传感器的一个方面,该磁性传感器被配置成能够检测超声医疗装置的弹簧堆叠部件的运动。
图16描绘了根据本公开的一个方面的外科器械的图示。
图17A和图17B分别描绘了向根据本公开的具有减振膜的超声医疗装置的压电换能器施加的电流与测量的电压的图示。
图17C和图17D分别描绘了向根据本公开的缺乏减振膜的超声医疗装置的压电换能器施加的电流与测量的电压的图示。
图18A是根据本公开的用于基于压电换能器阻抗值确定重新组装的夹持臂、延伸器和轴组件是否在预定公差范围内的方法的流程图。
图18B是根据本公开的基于压电换能器谐振频率值确定重新组装的夹持臂、延伸器和轴组件是否在预定的公差范围内的方法的流程图。
图19是根据本公开的用于确定管位移和弹簧堆叠位移是否在预定公差极限内的方法的流程图。
图20是根据本公开的用于确定钳口组件的夹持力是否在预定公差极限内的方法的流程图。
图21是根据本公开的确定重新组装的钳口致动组件是否在预定的公差极限内的方法的流程图。
图22是根据本公开的在超声医疗装置用于医疗规程之前对其进行预测试的方法的流程图。
图23是根据本公开的确定超声医疗装置的刀片是否在预定公差极限内操作的方法的流程图。
图24描绘了根据本公开的超声医疗装置的一个方面的纵截面。
图25是用于确定图24所描绘的超声医疗装置内不期望材料的存在的方法的流程图。
具体实施方式
本文所述的各个方面针对包括超声致动或超声刀的超声医疗装置。在一些方面,超声医疗装置还可包括定位为端部执行器的一部分的钳口组件,该钳口组件可用于抓持组织并将其朝向超声刀移动。
该钳口组件可以是可关节运动的并且可围绕至少两个轴线枢转。第一轴线或腕部枢转轴线可以基本垂直于装置轴的纵向轴线。钳口组件可围绕腕部枢转轴线从钳口组件基本平行于超声刀的第一位置枢转到钳口组件基本不平行于超声刀的第二位置。另外,钳口组件可包括可围绕第二轴线或钳口枢转轴线枢转的第一钳口构件和第二钳口构件。钳口枢转轴线可基本垂直于腕部枢转轴线。在一些方面,随着钳口组件围绕腕部枢转轴线枢转,钳口枢转轴线本身可枢转。第一钳口构件和第二钳口构件可围绕钳口枢转轴线相对于彼此枢转,使得第一钳口构件和第二钳口构件可“打开”和“闭合”。另外,在一些方面,第一钳口构件和第二钳口构件也可围绕钳口枢转轴线一起枢转,使得第一钳口构件和第二钳口构件的方向可改变。
现在将具体参考具有端部执行器的超声医疗装置的若干方面,该端部执行器包括具有或不具有钳口组件的超声外科元件。只要可行,相似或相同的参考标号可用于附图并且可表示相似或相同的功能。附图仅出于举例说明的目的描绘了本发明所公开的外科装置和/或使用方法的示例方面。本领域的技术人员将从以下描述容易地认识到可在不脱离本文所述原理的情况下采用本文例示的结构和方法的另选示例方面。
具体地讲,现在将具体参考超声医疗装置的各方面,该超声医疗装置包括一个或多个部件,这些一个或多个部件被设计成在使用该装置的医疗设施中被该装置的使用者清洁、消毒、替换和/或修复。此类设施可包括但不限于医院、诊所或其中该装置用作患者医疗规程一部分的任何其他设施。为了本公开的目的,此类超声医疗装置的“使用者”是医疗设施中在医疗规程之前、期间和/或之后与该装置相互作用的人。此类人可包括但不限于医生、护士、医生助理、技术人员、技师或生物医学工程师。
图1是超声外科装置10的一个方面的右侧视图。在例示的方面,超声外科装置10可用于各种外科规程,包括内窥镜式或常规开放式外科规程。在示例的方面,超声外科装置10包括柄部组件12、细长轴组件14和超声换能器16。柄部组件12包括触发器组件24、远侧旋转组件13和开关组件28。细长轴组件14包括端部执行器组件26,该端部执行器组件包括用于解剖组织或相互抓紧、切割并凝结血管和/或组织的元件,以及用于致动端部执行器组件26的致动元件。柄部组件12适于在近侧端部处接收超声换能器16。超声换能器16机械接合到细长轴组件14和端部执行器组件26的部分。超声换能器16经由缆线22电联接到发生器20。尽管大部分附图描绘了结合腹腔镜式外科规程使用的多个端部执行器组件26,但是超声外科器械10可用于更多传统的开放式外科规程中,并且在其他方面可被构造用于内窥镜式规程中。出于本文的目的,从内窥镜式装置的角度来描述超声外科装置10;然而,可以设想,超声外科装置10的开放式和/或腹腔镜式形式也可包括如本文所述的相同或相似的操作部件和特征部。
在各个方面,发生器20包括若干功能性元件,诸如模块和/或区块。不同的功能性元件或模块可被构造成用于驱动不同种类的外科装置。例如,超声发生器模块21可驱动超声装置,诸如超声外科装置10。在图1例示的示例方面中,发生器20包括与发生器20一体成型的控制系统25,以及经由缆线27连接至发生器的脚踏开关29。发生器20还可包括用于激活外科装置(诸如装置10)的触发器机构。触发器机构可包括电源开关(未示出)以及脚踏开关29。当由脚踏开关29激活时,发生器20可提供能量以驱动外科装置10的声学组件并以预定的偏移水平来驱动端部执行器18。发生器20以任何合适的声学组件的谐振频率来驱动或激发该声学组件。
合适的超声发生器模块21可被构造成能够在功能上以与Ethicon Endo-Surgery,Inc.公司(Cincinnati,Ohio)销售的GEN300相似的方式进行操作,如在以下美国专利中的一个或多个中所公开的(所有这些专利的全文以引用方式并入本文):美国专利6,480,796(Method for Improving the Start Up of an Ultrasonic System Under Zero LoadConditions);美国专利6,537,291(Method for Detecting Blade Breakage Using Rateand/or Impedance Information);美国专利6,662,127(Method for Detecting Presenceof a Blade in an Ultrasonic System);美国专利6,977,495(Detection Circuitry forSurgical Handpiece System);美国专利7,077,853(Method for CalculatingTransducer Capacitance to Determine Transducer Temperature);美国专利7,179,271(Method for Driving an Ultrasonic System to Improve Acquisition of BladeResonance Frequency at Startup);和美国专利7,273,483(Apparatus and Method forAlerting Generator Function in an Ultrasonic Surgical System)。
当发生器20经由触发器机构激活时,电能由发生器20连续地施加到声学组件的换能器堆叠或组件上。在另一个方面,电能由发生器20以间歇方式施加(例如,为脉冲的)。发生器20的控制系统中的锁相回路可监视来自声学组件的反馈。锁相环路调节由发生器20发送的电能的频率,使其与声学组件的选定纵向振动模式的谐振频率匹配。此外,控制系统25中的第二反馈回路将提供给声学组件的电流维持在预选的恒定水平,以便在声学组件的端部执行器18处实现基本上恒定的偏移。在又一个方面中,控制系统25中的第三反馈回路监视位于端部执行器组件26中的电极之间的阻抗。尽管图1至图4示出了手动操作的超声外科装置,但是应当理解,超声外科装置还可以用于,例如如本文所述的机器人应用中以及手动应用和机器人应用的组合中。
在一个方面,供应给声学组件的电信号可使得在端部执行器18的远侧端部处的超声刀在例如大约20kHz至250kHz的范围内纵向振动(横向模式)。然而,如下文所公开的,超声医疗装置的另选方面可以使超声刀以一种或多种非横向模式操作。根据各个方面,刀片22可在约54kHz至56kHz的范围内振动,例如以约55.5kHz振动。在其他方面,刀片22可以其他频率振动,包括例如约31kHz或约80kHz。可通过例如控制由发生器20施加到声学组件的换能器组件的电信号的幅值来控制刀片的振动偏移。如上所述,发生器20的触发器机构允许使用者激活发生器20,以便可将电能连续地或间歇地供应给声学组件。发生器20还具有电源线以便插入电外科单元或常规电源插座。据设想,还可以通过直流(DC)源诸如电池对发生器20供电。发生器20可包括任何合适的发生器,诸如可得自Ethicon Endo-Surgery,Inc的GEN04型和/或GENII型发生器。
图2是超声外科装置10的一个示例方面的左透视图,其示出了柄部组件12、远侧旋转组件13和细长轴组件14。在例示的方面,细长轴组件14包括尺寸被设计为机械地接合端部执行器组件18的远侧端部52,以及机械接合柄部组件12和远侧旋转组件13的近侧端部50。细长轴组件14的近侧端部50接收在柄部组件12和远侧旋转组件13内。关于细长轴组件14、柄部组件12和远侧旋转组件13之间的连接的更多细节在图4的描述中提供。在例示的方面,触发器组件24包括与固定柄部34结合操作的触发器32。固定柄部34和触发器32以符合人体工程学的方式形成,并且能够与使用者舒适地交接。固定柄部34与柄部组件12整体地相关联。触发器32可相对于固定柄部34以枢转方式移动,如在下文相对于超声外科装置10的操作更详细地解释。触发器32可当使用者施加相对于触发器32的挤压力时沿朝固定柄部34的方向33A可枢转地移动。弹簧元件98(图4)使触发器32在使用者释放相对于触发器32的挤压力时沿方向33B以枢转方式移动。
在一个示例方面,触发器32包括细长触发器钩36,其在细长触发器钩36与触发器32之间限定孔38。孔38的大小被设计成适于接收使用者的从中穿过的一根或多根手指。触发器32还可包括在触发器32基底的上方模制的弹性部分32a。包覆模制的弹性部分32a形成为提供更舒适的接触表面,以在向外的方向33B上控制触发器32。在一个示例方面,可在细长触发器钩36的一部分的上方提供包覆模制的弹性部分32a。细长触发器钩32的近侧表面保持未涂覆状态或用非弹性基底进行涂覆,以便使用者能够轻易地将其手指滑入和滑出孔38。在另一个方面,触发器的几何结构形成完全闭合的回路,其限定大小被设计成适于接收使用者的从中穿过的一根或多根手指的孔。完全闭合的回路触发器也可以包括在触发器基底的上方模制的弹性部分。
在一个示例方面,固定柄部34包括近侧接触表面40和握持锚定件或鞍形表面42。鞍形表面42倚靠在手上拇指和食指结合的指蹼上。近侧接触表面40具有手枪式握把轮廓,其在没有环或孔的普通手枪式握把上接收手掌。近侧接触表面40的轮廓弯曲可为波状外形的以适应或接收手掌。稳定化尾部44位于朝向柄部组件12的更近侧的部分。稳定化尾部44可以与手的位于拇指与食指之间的最上方指蹼部分接触,以稳定柄部组件12并使柄部组件12更易于控制。
在一个示例方面,开关组件28可包括拨动开关30。拨动开关30可以实施为位于柄部组件12内部的具有中心枢轴304的单个部件,以消除同时激活的可能性。在一个示例方面,拨动开关30包括第一突出旋钮30a和第二突出旋钮30b,用于将超声换能器16的功率设置设定在最小功率电平(例如,MIN)与最大功率电平(例如,MAX)之间。在另一个方面,摇臂开关可在标准设置与特殊设置之间枢转。特殊设置可以允许装置实现本文所述的一个或多个特殊程序、过程或算法。当第一突出旋钮30a和第二突出旋钮30b被致动时,拨动开关30围绕中心枢轴旋转。一个或多个突出旋钮30a、30b联接到一个或多个臂,这些一个或多个臂移动通过一小段弧并且使电触点根据第一突出旋钮或第二突出旋钮30a、30b的启动情况来闭合或断开电路从而以电方式为超声换能器16供能或使该超声换能器去能。拨动开关30联接到发生器20以控制超声换能器16的启动。拨动开关30包括用于启动超声换能器16的一个或多个电功率设置开关来为超声换能器16设定一项或多项功率设置。启动拨动开关30所需的力被指向为基本朝向鞍形点42,由此避免了在启动拨动开关30时装置在手中旋转的任何趋势。
在一个示例方面,第一突出旋钮30a和第二突出旋钮30b位于柄部组件12的远侧端部上,使得它们能被使用者轻易地触及,从而在最低程度或基本无需重新定位握把的情况下激活电源,因此适于在启动拨动开关30的同时维持控制并将注意力集中在外科位点(例如,腹腔镜式规程中的监视器)上。突出旋钮30a、30b可被构造成能够卷绕柄部组件12的侧面至一定程度,以便更易于被不同长度的手指触及,并且在不顺手位置或针对较短的手指允许较大的触及自由度来启动突出旋钮。在该例示方面,第一突出旋钮30a包括多个触觉元件30c,如该例示方面中的纹理突出或“凸耳”,以允许使用者区分第一突出旋钮30a和第二突出旋钮30b。本领域的技术人员应当理解,可将若干人体工程学特征结构结合到柄部组件12中。此类人体工程学特征部在名称为“Ergonomic Surgical Instruments”的美国专利No.8,623,027中有所描述,该专利申请公布全文以引用方式并入本文。
在一个示例方面,拨动开关30可以由使用者的手操作。使用者可以在任何点轻易地触及第一突出旋钮30a和第二突出旋钮30b,同时还避免在任何时间意外或无意启动。拨动开关30可以方便地由手指操作以控制传输至超声组件16的功率。例如,食指可用于启动第一接触部分30a以将超声组件16接通到最大(MAX)功率电平。食指可用于启动第二接触部分30b以将超声组件16接通到最小(MIN)功率电平。在另一个方面,摇臂开关可使装置10在标准设置与特殊设置之间枢转。特殊设置可允许由装置10执行一个或多个特殊程序。使用者无需观察第一突出旋钮30a或第二突出旋钮30b便可以操作拨动开关30。例如,第一突出旋钮30a或第二突出旋钮30b可以包括纹理或突出,因而无需观察便可以触觉方式区分第一突出旋钮30a和第二突出旋钮30b。
在一个示例方面,远侧旋转组件13可绕纵向轴线“T”在任一方向上不受限制地旋转。远侧旋转组件13机械接合到细长轴组件14。远侧旋转组件13位于柄部组件12的远侧端部上。远侧旋转组件13包括圆柱形轮毂46和在轮毂46的上方形成的旋转旋钮48。轮毂46机械接合细长轴组件14。旋转旋钮48可包括带凹槽的聚合物特征部,并可以用手指(例如,食指)接合以旋转细长轴组件14。轮毂46可以包括在主结构的上方模制的用于形成旋转旋钮48的材料。旋转旋钮48可在轮毂46上包覆模制。轮毂46包括在远侧端部露出的端盖部分。在腹腔镜式规程期间,轮毂46的端盖部分可以接触套管针的表面。轮毂46可以由诸如聚碳酸酯的硬质耐用塑料形成,用于缓解端盖部分46a与套管针之间可能出现的任何摩擦。旋转旋钮48可以包括由突肋48a形成的“扇形凹口”或凹槽以及位于肋48a之间的凹面部分48b,从而得到更加精确的旋转握持。在一个示例方面,旋转旋钮48可包括多个凹槽(例如,三个或更多个凹槽)。在其他方面,可以采用任何适合数量的凹槽。旋转旋钮48可以由在硬质塑性材料上包覆模制的较软聚合材料形成。例如,旋转旋钮48可以由柔韧的、有弹性的、柔性的聚合材料(包括例如GLS公司制造的TPE合金)形成。这种较软的包覆模制材料可以提供更好的握持,以及对旋转旋钮48的移动的更加精确的控制。应当理解,任何充分地耐受灭菌处理、具有生物相容性且对外科手套提供足够摩擦阻力的材料都可以用于形成旋转旋钮48。
在一个示例方面,柄部组件12由包括第一部分12a和第二部分12b的两(2)个外壳部分或护罩形成。从使用者的角度由远侧端部朝近侧端部观察柄部组件12,第一部分12a被视为右侧部分,第二部分12b被视为左侧部分。第一部分12a和第二部分12b中的每个包括多个接合部69(图4),这些多个接合部的尺寸被设计成彼此机械对准并接合以形成柄部组件12并且封闭其内部工作部件。与柄部组件12整体地相关联的固定柄部34在组装柄部组件12的第一部分12a和第二部分12b后成形。可以围绕柄部组件12的第一部分12a和第二部分12b的周边的多个点处设置多个附加的接合部(未示出),例如能量方向点/挠曲点,以用于超声焊接的目的。可以按本领域已知的任何方式将第一部分12a和第二部分12b(以及下文所述的其他部件)组装在一起。例如,定位销、按扣型接口、舌状物接口和凹槽接口、锁定接片、粘结端口可以单独或组合用于组装目的。
在一个示例方面,细长轴组件14包括适于机械接合柄部组件12和远侧旋转组件13的近侧端部50;以及适于机械接合端部执行器组件18的远侧端部52。细长轴组件14包括外部管状护套56和位于外部管状护套56内的往复式管状致动构件58。该管状往复式管状致动构件58的近侧端部机械接合到柄部组件12的触发器32,以响应于触发器32的致动和/或释放而在方向60A或60B上移动。可以可枢转地移动的触发器32可以生成沿着纵向轴线“T”的往复式运动。此类运动可用于例如致动端部执行器组件18的钳口或夹持机构。一系列连杆将触发器32的枢转旋转转化成联接到致动机构的轭的轴向移动,该轴向移动控制端部执行器组件18的夹持机构的钳口的打开和闭合。管状往复式管状致动构件58的远侧端部机械接合到端部执行器组件18。在该例示的方面,管状往复式管状致动构件58的远侧端部机械接合到可围绕枢转点70枢转的夹持臂组件64(图3),以响应于触发器32的致动和/或释放而打开和闭合夹持臂组件64。例如,在该例示的方面,当沿方向33A挤压触发器32时,夹持臂组件64可围绕枢转点70沿方向62A从打开位置移动到闭合位置。当沿方向33B释放触发器32或使其向外接触时,夹持臂组件64可围绕枢转点70沿方向62B从闭合位置移动到打开位置。
在一个示例的方面,端部执行器组件18附接在细长轴组件14的远侧端部52处,并且包括夹持臂组件64和刀片66。端部执行器组件18的夹持机构的钳口由夹持臂组件64和刀片66形成。刀片66可超声致动并声学地联接到超声换能器16。柄部组件12上的触发器32最终连接至驱动组件,它们一起机械配合以实现夹持臂组件64的移动。沿方向33A挤压触发器32使夹持臂组件64沿方向62A从打开位置移动到夹持或闭合位置,在打开位置,夹持臂组件64和刀片66相对于彼此间隔设置,在夹持或闭合位置,夹持臂组件64和刀片66配合以夹持其间的组织。夹持臂组件64可包括夹持垫330,该夹持垫例如机械联接到夹持臂组件64的表面,以接合刀片66与夹持臂64之间的组织。沿方向33B释放触发器32使夹持臂组件64沿方向62B从闭合关系移动到打开位置,在打开位置,夹持臂组件64和刀片66相对于彼此间隔设置。
柄部组件12的近侧部分包括近侧开口68,用于接收超声组件16的远侧端部。超声组件16插入近侧开口68并且机械接合到细长轴组件14。
在一个示例的方面,触发器32的细长触发器钩36部分提供较长的触发器杠杆以及较短的跨度和旋转行程。细长触发器钩36的较长杠杆允许使用者在孔38内使用多根手指来操作细长触发器钩36,并且使触发器32沿方向33B枢转以打开端部执行器组件26的钳口。例如,使用者可以将三根手指(例如,中指、无名指和小指)插入孔38中。多根手指使得外科医生可在触发器32和细长触发器钩326上施加较高的输入力来启动端部执行器组件26。当沿方向33A闭合或挤压触发器32或沿方向33B通过向外打开运动打开触发器32时,较短的跨度和旋转行程产生更舒适的握持,从而减少进一步向外伸出手指的需求。这将显著减轻与触发器32沿方向33B的向外打开运动相关联的手部疲劳和紧张。触发器的向外打开运动可以由弹簧元件98(图4)弹簧协助以有助于缓解疲劳。开启弹簧力足以协助轻易地开启,但不足以在展开解剖期间对组织张力的触觉反馈造成不利影响。
例如,在外科规程期间,任意食指可用于控制细长轴组件14的旋转,以将端部执行器组件26的钳口定位在合适的取向上。中指和/或其他较短手指可用于挤压触发器32和抓握钳口内的组织。一旦钳口位于期望位置并且钳口夹持住组织,食指就可用于启动拨动开关30,从而调节超声换能器16的用于处理组织的功率电平。一旦已经处理了组织,使用者就可以使用中指和/或较短手指抵靠细长触发器钩36沿远侧方向向外推动来释放触发器32,从而打开端部执行器组件26的钳口。使用者不必调节其对柄部组件12的握持即可执行此基本过程。
图3示出了细长轴组件14相对于端部执行器组件18的连接。如前所述,在该例示的方面,端部执行器组件18包括夹持臂组件64和刀片66以形成夹持机构的钳口。刀片66可以是声学地联接到超声换能器16的可超声致动的刀片。触发器32机械地连接至驱动组件。触发器32和驱动组件共同机械配合以沿方向62A将夹持臂组件64移动到打开位置,在该位置夹持臂组件64和刀片66相对于彼此间隔设置,并且沿方向62B将夹持臂组件移动到夹持或闭合位置,在该位置夹持臂组件64和刀片66配合以夹持其间的组织。夹持臂组件64可以包括夹持垫330以接合刀片66与夹持臂64之间的组织。管状往复式管状致动构件58的远侧端部机械接合到端部执行器组件18。在该例示的方面,管状往复式管状致动构件58的远侧端部机械接合到可围绕枢转点70枢转的夹持臂组件64,以响应于触发器32的致动和/或释放而打开和闭合夹持臂组件64。例如,在该例示的方面,当沿方向33A挤压触发器32时,夹持臂组件64可围绕枢转点70沿方向62B从打开位置移动到闭合位置。当沿方向33B释放触发器32或使其向外接触时,夹持臂组件64可围绕枢转点70沿方向62A从闭合位置移动到打开位置。
图4是图2所示的超声外科装置10的分解图。在该例示的方面,该分解图示出了柄部组件12、柄部组件12、远侧旋转组件13、开关组件28和细长轴组件14的内部元件。在该例示的方面,第一部分12a和第二部分12b配合以形成柄部组件12。第一部分12a和第二部分12b各自包括多个接合部69,这些多个接合部的尺寸被设计成彼此机械对准并接合以形成柄部组件12并且封闭超声外科装置10的内部工作部件。旋转旋钮48机械接合到外部管状护套56,使得其可以沿圆形方向54旋转多至360°。外部管状护套56位于往复式管状致动构件58之上,该往复式管状致动构件经由多个联接元件72机械接合到柄部组件12并保留在其内。联接元件72可包括O形环72a、管套环帽72b、远侧垫圈72c、近侧垫圈72d和螺纹管套环72e。往复式管状致动构件58位于往复式轭84内,该往复式轭保留在柄部组件12的第一部分12a与第二部分12b之间。轭84是往复式轭组件88的一部分。一系列连杆将细长触发器钩32的枢转旋转转化成往复式轭84的轴向移动,该轴向移动控制超声外科装置10远侧端部处的端部执行器组件26的夹持机构的钳口的打开和闭合。在一个示例的方面,四连接件设计提供例如在相对短的旋转跨度方面的机械优势。
在一个示例的方面,超声传输波导78设置在往复式管状致动构件58的内部。超声传输波导78的远侧端部52在声学地联接(例如,直接或间接机械联接)到刀片66,并且超声传输波导78的近侧端部50接收在柄部组件12内。超声传输波导78的近侧端部50适于在声学地联接到超声换能器16的远侧端部。超声传输波导78通过保护护套80和多个隔离元件82(诸如硅胶环)与细长轴组件14的其他元件隔离。在一些方面,保护护套80可以用作减振膜,该减振膜可以使得使用者与在波导和/或超声刀中感应出的机械振动隔离。在一些示例中,保护护套80可以被制造为管状部件,其中设置了超声传输波导78。在其他示例中,保护护套可以被制造为平坦的膜,该平坦的膜被形成为用于插入超声医疗装置10的部分圆柱形板。外部管状护套56、往复式管状致动构件58和超声传输波导78通过销74机械地接合。开关组件28包括拨动开关30和电气元件86a、b,用于根据第一突出旋钮30a或第二突出旋钮30b的启动来以电方式为超声换能器16供能。
在一个示例的方面,外部管状护套56将使用者或患者与超声传输波导78的超声振动隔离。外部管状护套56通常包括轮毂76。外部管状护套56通过螺纹连接到柄部组件12的远侧端部上。超声传输波导78延伸穿过外部管状护套56的开口,而隔离元件82将超声传输波导24与外部管状护套56隔离。外部管状护套56可使用销74附接到波导78。波导78中用于接收销74的孔可以标称地出现在位移波节处。波导78可通过双头螺栓螺旋进入或卡扣到手持式柄部组件12中。轮毂76上的平坦部分可以允许组件扭转至所需的程度。在一个示例的方面,外部管状护套56的轮毂76部分优选地由塑料构造,并且外部管状护套56的管状细长部分由不锈钢制成。另选地,超声传输波导78可以包括围绕在其周围的聚合材料,以使其与外部接触隔离。
在一个示例的方面,超声传输波导78的远侧端部可以通过内部螺纹连接而联接到刀片66的近侧端部,优选地位于或靠近波腹。可以设想,刀片66可通过诸如焊接接头等任何合适的手段附接到超声传输波导78。尽管刀片66可从超声传输波导78上拆卸,但也可设想,单个元件端部执行器(例如,刀片66)和超声传输波导78形成为单个一体部件。
在一个示例的方面,触发器32联接到连杆机构以将触发器32沿方向33A和33B的旋转运动转化为往复式管状致动构件58沿对应方向60A和60B的线性运动(图2)。触发器32包括其中形成有开口以接收第一轭销94a的第一组凸缘98。第一轭销94a还定位穿过在轭84的远侧端部处形成的一组开口。触发器32还包括用于接收连接件92的第一端部的第二组凸缘96。触发器销90接收在形成于连接件92和第二组凸缘96中的开口内。触发器销90接收在形成于联接件92和第二组凸缘96中的开口内,并且适于联接到柄部组件12的第一部分12a和第二部分12b以形成触发器32的触发器枢转点。连接件92的第二端部接收在形成于轭84的近侧端部中的狭槽内,并通过第二轭销94b保留在其中。随着触发器32围绕由触发器销90形成的枢转点以枢转方式旋转,轭在箭头60a、b指示的方向上沿着纵向轴线“T”水平平移。
图5描绘了超声医疗装置10的另一个方面,包括附加部件。因此,往复式管状致动构件58可联接到包括远侧凸缘572a和近侧凸缘572b的往复式套环。往复式轭84可在设置在远侧凸缘572a与近侧凸缘572b之间的某个位置接合往复式套环。往复式套环可以设置在弹簧堆叠578内。弹簧堆叠578可设置在往复式轭84与近侧凸缘572b之间。可以在往复式轭84与弹簧堆叠578的远侧端部之间定位附加的轴承板573,从而当触发触发器32时保护弹簧堆叠578免受往复式轭84的机械变形。
当触发器32被致动时,可在近侧方向上拉动往复式轭84,从而在近侧方向上拉动往复式管状致动构件58。当往复式轭84向近侧移动时,它可能会抵靠轴承板573拉动并压缩弹簧堆叠578。一旦释放触发器,压缩的弹簧堆叠578就向往复式管状致动构件58提供恢复力,从而沿远侧方向将其推回。
超声医疗装置10还可包括声学地联接到波导78的超声换能器16。超声医疗装置10还可包括适于测量与超声医疗装置10的一个或多个部件的操作相关联的功能数据的任意数量的传感器和传感器电子器件,如将在下文详细描述的。
图6描绘了超声换能器16的一方面,其可包括超声换能器组件616。超声医疗装置10的一方面包括电联接到超声换能器16的超声信号发生器模块21。在一个方面,超声换能器组件616可包括设置在“Langevin堆叠”中的多个圆柱形压电换能器632。当此类“Langevin堆叠”声学地联接到超声波导678时,可以在该超声波导中感应出横向声波。压电换能器632中的每个可以通过在其相对的面之间施加电压来致动。超声换能器组件616还可包括在近侧联接到压电换能器632的第一谐振器或端罩620,以及在远侧联接到压电换能器632的第二谐振器或前罩622,以及辅助部件。在各个方面,超声换能器组件616的长度优选地为二分之一系统波长的整数倍(nλ/2),如下面所详细描述。超声声学组件616还可包括安装架和速度变压器。
端罩620的远侧端部连接到“Langevin堆叠”的近侧端部,而前罩622的近侧端部连接到“Langevin堆叠”的远侧端部。前罩622和端罩620的长度由多个变量来确定,包括“Langevin堆叠”的厚度、用于制造端罩620和前罩622的材料的密度和弹性模量以及超声换能器组件616的谐振频率。可使前罩622从其近侧端部到其远侧端部向内成锥形,用于放大超声振动振幅。另选地,前罩622可以不具有放大。
再参考图6,端罩620可包括从其延伸的螺纹构件,该螺纹构件可被构造成能够与前罩622中的螺纹孔通过螺纹接合。在各个方面,当端罩620和前罩622组装在一起时,压电元件(例如,压电元件632)可被压缩于端罩620与前罩622之间。超声换能器组件616可包括尾部617,该尾部还可通过端罩620向压电元件632提供压缩力。可以认识到,在端罩620与前罩622之间对压电元件632的适当压缩可用于确保压电元件632与前罩622之间的良好机械联接。良好的机械联接可优化通过电场在压电元件632中感应的到超声系统10的远侧部件中的运动的传输。压电元件632可由任何合适的材料制成,诸如,例如锆钛酸铅、偏铌酸铅、钛酸铅和/或任何合适的压电晶体或陶瓷材料。
在各个方面,如下面更详细讨论,超声换能器组件616还可包括电极,诸如正电极和负电极,例如,这些电极可被构造成能够在一个或多个压电元件632两端形成电势。正电极、负电极和压电元件632中的每个可包括延伸穿过中心的孔,该孔可被构造成能够接收端罩620的螺纹构件。在各个方面,正电极和负电极电联接到包裹在线缆内并且可电连接至超声系统10的超声信号发生器21的导线。
在各个方面,超声换能器616的压电元件632设置在“Langevin堆叠”中,将超声信号发生器21产生的电信号转换为机械能,这导致在超声换能器组件616的超声频率处主要的纵向(横向模式)振动运动通过波导678到达端部执行器组件18。合适的发生器为得自Ethicon Endo-Surgery,Inc.(Cincinnati,Ohio)的型号GEN11。当超声换能器组件616通电时,会通过波导678产生振动运动驻波。合适的振动频率范围可为约20Hz至120kHz,较为适当的振动频率范围可为约30kHz至70kHz,一个示例性的操作振动频率可为大约50kHz。
沿着超声换能器组件616和波导678(一起包括声学组件)的任何点处的振动运动的振幅可以取决于沿着声学组件的在其处测量振动运动的位置。振动驻波的最小或零交点通常称为波节(即,运动通常最小的位置),而驻波的最大绝对值或峰值通常称为波腹(即,运动通常最大的位置)。波腹与距其最近的节点之间的距离为四分之一波长(λ/4)。
在各个方面,由超声换能器组件616产生的超声能量可以经由超声传输波导678被传输到端部执行器组件18。为了使声学组件将能量递送到端部执行器组件18,声学组件的部件声学地联接到端部执行器组件18。例如,超声换能器616的远侧端部可通过螺纹连接与超声传输波导管678的近侧端部声学地联接。
可对声学组件的部件进行声学调谐,使得任何组件的长度均为二分之一波长的整数倍(nλ/2),其中波长λ是声学组件的预选或工作纵向振动驱动频率fd的波长,并且其中n为任意正整数。还设想声波组件可以结合任何合适的声波元件布置。
超声端部执行器18的长度可基本上等于系统半波长(λ/2)的整数倍。超声端部执行器18的远侧端部可设置在波腹处或至少附近,以便提供超声换能器组件616的远侧端部的最大或至少近乎最大的纵向偏移,该超声换能器组件包括设置在“Langevin堆叠”中的压电元件632。在多个方面中,当换能器组件通电时,超声端部执行器18的远侧端部可被构造成能够以预定振动频率在例如大约10至500微米峰到峰的范围内移动,并且优选地在大约30至150微米的范围内移动。
如上所述,超声端部执行器18可联接至超声传输波导管678。在多个方面中,如图所示的超声端部执行器18和超声传输波导管678由适合超声能量传输的材料形成为单个单元构造,这些材料诸如例如为Ti6Al4V(含铝和钒的钛合金)、铝、不锈钢和/或任何其他合适的材料。另选地,超声端部执行器18可与超声传输波导管678分离,并可通过例如螺柱、焊接、粘合剂、快速连接或其他合适的已知方法联接在一起。超声传输波导管678的长度可例如基本上等于二分之一系统波长(λ/2)的整数倍。超声传输波导管678可优选地由使用诸如钛合金(即,Ti6Al4V)或铝合金适合高效传输超声能量的材料制造的实芯轴加工而成。
一般来讲,电压或电源可以与超声换能器组件的一个或多个压电元件可操作地联接,其中施加到每个压电元件的电压电势可以使压电元件伸展和收缩或振动。也如上所述,电压电势可为循环的,并且在各个方面,电压电势可以与具有包括例如超声换能器组件616、波导管678和端部执行器18的部件的系统的谐振频率相同(或几乎相同)的频率循环。
通过以波节或波节附近的频率或超声换能器组件616的阻抗最小的谐振频率(fr)操作压电元件632,可使功率最大化。可能需要最小的功率量来以波腹或波腹附近的频率或超声换能器组件616的阻抗最大的反谐振频率(fa)操作压电元件632。
图6描绘了声学组件的一个方面,该声学组件可以被构造成能够将机械能的直立横向波感应到超声外科装置的端部执行器。图7至图9描绘了声学组件的另外的方面,该声学组件可以被构造成能够将非横向机械能感应到端部执行器。
图7示出了超声声学组件700的一个方面,该超声声学组件结合了一个或多个压电换能器912a、b,这些压电换能器被构造成能够以D31模式操作。超声声学组件700可包括波导378和换能器安装部分320。在一些方面,声学组件700可以由片材原料制成并且具有基本平坦的表325和与平坦的表325正交的侧边缘327。波导378可在远侧端部处声学地联接到端部执行器18,并且换能器安装部分320位于声学组件700的近侧端部处。一个或多个压电换能器912a、b可以固定到声学组件700的换能器安装部分320。在某些方面,波导378还可包括定位于多个振动波节处或至少附近的一个或多个稳定的硅树脂环或适形支撑件,其可以抑制不期望的振动并且将超声能量与至少部分围绕声学组件700的护套隔离。为了使压电换能器912a、b在D31模式下操作,第一电极可以电联接到换能器(例如912a)的暴露面,该换能器的与换能器的面相对的面与声学组件700的面325机械连通。在一些方面,可以在压电换能器912a、b的暴露面上涂漆或丝网印刷导电电极(例如,银电极),然后可以将导线焊接到导电电极上。另选地,可以借助于导电环氧树脂将导线固定到压电换能器912a、b的暴露面。声学组件700可以电联接到第二电极,从而允许将电场施加到与波导378的纵向轴线正交的声学组件700上。
图8是图7的声学组件700的换能器安装部分320的近距离视图,其示出了可以在每个压电换能器912a、b的面与声学组件700的面325之间进行的机械接触。在图8例示的方面,单对压电换能器912a、b接触声学组件700,每个换能器接触声学组件700的相对面。可以观察到,一对压电换能器912a、b中的每个彼此相对。如以上关于图6所公开的,压电换能器912a、b可以由电源以预定的频率激活,以沿声学组件700的主体感应出机械驻波。驻波可以与电信号的预定的频率分量成比例。沿着声学组件700的主体感应的驻波可以一个或多个波节和波腹来表征。驻波波节可以有效地集中在声学组件700上的一个或多个波节位置,并且驻波波腹可以有效地集中在声学组件700上的一个或多个波腹位置。每个压电换能器912a、b可以围绕声学组件700的换能器安装部分320中的波节位置对称地设置。此类设置可导致每个换能器912a、b在换能器912a、b的激活期间在具有最小机械位移的位置处接触声学组件700的一部分。
图9示出了一个方面,其中第一换能器912a包括第一换能器板的第一平面阵列,并且第二换能器912b包括第二换能器板的第二平面阵列。如图9所示,第一换能器912a包括第一换能器板的第一平面阵列,其由数字1、2、3和4表示。第二换能器912b包括第二换能器板的第二平面阵列(在图9的透视图中不可见),其由括号(5)、(6)、(7)和(8)中的数字表示。应当理解,第二换能器板(5)相对于第一换能器板1设置在换能器安装部分320的相对侧,第二换能器板(6)相对于第一换能器板2设置在换能器安装部分320的相对侧,第二换能器板(7)相对于第一换能器板3设置在换能器安装部分320的相对侧,并且第二换能器板(8)相对于第一换能器板4设置在换能器安装部分320的相对侧。换能器板1、(5)、3和(7)可以围绕波节位置的一侧设置,并且换能器板2、(6)、4和(8)可以围绕波节位置的相对侧设置。
应当理解,图7至图9的各方面中所描绘的换能器或换能器板都可以由相同的材料制成。另选地,在图7至图9的各方面中所描绘的换能器或换能器板可以由不同的材料制成。例如,换能器或换能器板可以由它们相应的应变常数、介电损耗或阻尼特性、介电常数、电压灵敏度或居里温度不同的压电材料制成。类似地,换能器或换能器板都可以具有相同的形状和尺寸。另选地,换能器或换能器板的形状、尺寸或形状和尺寸两者可以不同,这取决于它们在外科工具上或彼此上的相应布置。
图7至图9所描绘的每个换能器或换能器板可以被单独激活。在一些方面,每个换能器或换能器板可以由单独的超声信号发生器激活,其中各个超声信号发生器具有与声学组件电通信的公共接地。在此类方面,每个换能器或换能器板可以通过分开的电信号来激活。在一些示例中,分开的电信号的电特性可以是相同的,例如具有相同的振幅、频率和相位。在另选的示例中,分开的电信号的电特性可以在振幅、频率和相位中的一个或多个方面不同。在另选的方面中,每个换能器或换能器板可以由相同的超声信号发生器激活,但是可以由一个或多个换能器激活开关分别激活。此类开关可以将超声信号的第一极性指引一组换能器或换能器板,并且将超声信号的第二极性指引第二组换能器或换能器板。应当理解,此类开关还可以用于从超声信号发生器断开一个或多个换能器或换能器板的连接,同时允许其他换能器或换能器板接收来自超声信号发生器的超声信号。
在至少一个此类方面,超声外科装置可包括一个或多个开关,这些一个或多个开关可以被构造成能够选择性地致动换能器或换能器板。例如,可以将开关从断开位置移动到第一位置以便致动第一换能器或一组换能器板,而将其移动到第二位置以便致动第二换能器或一组换能器板。可以认识到,在诸如图9所描绘的方面中,此类开关可以具有多个位置,每个位置被构造成能够致动指定的一批换能器板。在某些其他方面,超声医疗装置可包括构造成选择性地致动第一换能器或一组换能器板的第一开关,以及另外构造成选择性地致动第二换能器或一组换能器板的第二开关。在此类方面,外科医生可以选择要供应给外科工具和/或端部执行器的功率。在另选方面,可以根据驻留在控制系统25的存储器部件中的指令来自动控制供应给换能器或一组换能器板中的任一个或多个的功率。
可以认识到,换能器或换能器板的切换激活可以导致外科工具的振动图案,该振动图案比单个横向机械驻波更复杂。此类复杂的机械波可用于将复杂的移动赋予超声医疗装置的端部执行器。例如,相对于图9所示的方面,如果用第一极性超声信号激活换能器板1、2、(5)和(6),而用第二和相对极性超声信号激活换能器板3、4、(7)和(8),则在端部执行器中可能会感应出主要的横向摇摆运动。如果用第一极性超声信号激活换能器板1、(5)、3和(7),而用第二和相对极性超声信号激活换能器板2、(6)、4和(8),则在端部执行器中可能会感应出主要的横向钩挂运动。如果用第一极性超声信号激活换能器板1、(7)、2和(8),而用第二和相对极性超声信号激活换能器板3、(5)、4和(6),则在端部执行器中可能会感应出主要的扭动运动。如果用第一极性超声信号激活换能器板1、(7)、4和(6),而用第二和相对极性超声信号激活换能器板(5)、3、2和(8),则在端部执行器中可能会感应出扭动和横向运动的组合。可以通过激活其他批换能器板来实现另外的运动。
从图1至图9和所附公开的内容中可以明显看出,由于该装置的使用,超声医疗装置10的许多部件可能需要清洁、消毒、替换或修复。在一个示例中,超声刀66在使用后可能会被组织覆盖,或者由于在使用期间感应出的机械振动而遭受点蚀、断裂和/或开裂,因此需要对刀片66进行清洁、消毒和/或替换。由于组织在枢轴上的积聚,夹持臂组件64可能无法完全围绕枢轴点70旋转,因此需要清洁或修复。垫330类似地在使用期间会遭受组织材料的积聚,或者由于暴露于振动的超声刀66而可能产生表面磨损,因此需要清洁或替换。外部管状护套56的远侧端部可以类似地在其外表面和其内表面上积聚生物碎片,并且需要清洁。管状护套56内部的生物碎片的积聚会影响往复式管状致动构件58的性能,从而减少或削弱其行程。波导中的感应振动(例如78)可能会导致材料疲劳,并且最终导致波导中出现断裂或弯曲,因此需要修复和/或替换。由于不断暴露于波导的振动,可能会在保护护套80中感应出磨损,因此需要替换。
容纳在柄部组件12中的机械部件可能会发生另外的磨损。在多次伸展或压缩之后,弹簧元件98和弹簧堆叠578可能失去弹性,因此可能需要替换。还可以认识到,超声换能器组件(例如616)的一个或多个部件可能遭受机械磨损并且需要修复和/或替换。在一个非限制性示例中,机械振动可导致超声换能器组件616的部件(例如,尾部617、端罩620和前罩622)松弛,从而减少了压电换能器(例如632)与波导(例如678)之间的机械联接。类似地,在波导678和超声换能器组件616的界面处的机械振动可以减少换能器组件616通过波导678到超声刀66的机械联接。
可以认识到,在超声医疗装置10的部件上的此类磨损示例是非限制性的,并且本文未提及的其他部件也可能需要清洁、替换和/或修复。如上所公开的,尽管对超声医疗装置的使用者进行清洁、替换和/或修复结垢、破裂和/或损坏的部件是有益的,但是使用者必须能够在维修后且随后重复使用之前成功地重新组装医疗装置10。因此,对于可重复使用的医疗装置而言有用的是结合特征部以确保医疗装置在重新组装时能够正常运行,或者通知使用者重新组装未成功并且在正确进行重新组装之前不使用重新组装的医疗装置10。
在一些方面,帮助使用者适当地重新组装医疗装置10的特征部可包括各种传感器。此类传感器可以设置在装置中的多个位置中的任何位置,并且可以被构造成能够测量装置部件的机械功能。另外,此类传感器可以警告使用者医疗装置10的一个或多个部件需要检查、清洁、替换和/或修复。
返回图5,此类传感器的一些非限制性示例可包括触发器传感器532。此类触发器传感器532可包括力传感器,该力传感器被配置成能够指示在致动时施加到触发器32的力的量。另选地,触发器传感器532可包括位置传感器,该位置传感器被配置成能够确定触发器32已经被使用者按下了多深。在一个非限制性方面,触发器传感器532可以电联接到电路板553,该电路板可包括各种装置电子期间,该装置电子器件可包括被构造成能够接受来自设置在医疗装置10内的一个或多个传感器的电数据的电子器件。此类触发器传感器532的示例可包括但不限于磁性接近传感器、电感传感器、电容传感器、电阻传感器和光学传感器。
传感器的另一个示例可以是弹簧力传感器,该弹簧力传感器被配置成能够当按下触发器32时测量由轭84施加在弹簧堆叠578上的压缩力。当触发器32被按下时,轭84可通过触发器组件连杆590在近侧方向上移动。在一个非限制性实施方案中,弹簧力传感器可包括设置在轭84与弹簧堆叠578之间的压电盘575。可以认识到,当压缩压电材料时,在压电材料的两个表面之间会产生电势。因此,包括压电盘575的弹力传感器可包括与压电盘575的表面的电接触。
如图5所描绘,近侧表面触点565a和远侧表面触点565b可以电联接到压电盘575的相应近侧和远侧表面。近侧和远侧表面触点565a、b可以分别电联接到轮毂触点555a、b,这些轮毂触点可以分别设置在细长轴组件14的轮毂576上。如上所公开的,细长轴组件14与外部管状护套56和往复式管状致动构件58一起被构造成能够相对于柄部组件12围绕纵向轴线旋转。因此,可以提供旋转滑动接头540以允许轮毂触点555a、b保持与可固定在柄部组件12中的参考系中的导线或其他导电部件的电连通性。在一个非限制性示例中,导电部件可以终止于电路板553,该电路板包括一个或多个传感器电子器件,这些一个或多个传感器电子期间被构造成能够接收来自与超声医疗装置10相关联的传感器部件的一个或多个电信号。
尽管图5描绘了压电盘575位于轴承板573与弹簧堆叠578的远侧端部之间,但是可以认识到,压电盘575可以适当地沿着轭84与近侧凸缘572b之间的往复式套环放置在任何地方,以便测量弹簧堆叠578的压缩力。因此,作为非限制性示例,压电盘575也可以位于轭84的近侧表面与轴承板573的远侧表面之间,或者在弹簧堆叠578的近侧端部和近侧凸缘572b的远侧表面之间。
可以采用几种类型或构型的传感器来确保构造成致动夹持臂组件64的钳口的部件正确地操作。此类部件的示例可包括但不限于往复式管状致动构件58、包括其远侧凸缘572a和近侧凸缘572b的往复式套环以及弹簧堆叠578。图10至图15描绘了可以单独使用或以任何组合或组合使用的若干传感器,以感测部件的运动。
图10至图11描绘了一个或多个传感器,这些一个或多个传感器可以提供对往复式管状致动构件58的往复式运动的指示。在一个方面,如图10A和图10B所描绘,往复式管状致动构件58可设置在一个或多个感应回路1010、1015内。往复式管状致动构件58可包括一个或多个铁电金属带1020,这些一个或多个铁电金属带沿着往复式管状致动构件58的外表面的一部分设置。应当理解,由铁电材料制成的管状套环可以代替一个或多个铁电金属带1020。在一个非限制性示例中,当钳口处于打开状态时,一个或多个铁电金属带1020可以设置在感测感应回路1015内。当往复式管状致动构件58如图10A中的箭头所描绘沿近侧方向平移时(并且钳口改变为闭合状态),如图10B所描绘,一个或多个铁电金属带1020可被平移到感测电感回路1015中,从而改变感测电感回路1015的电感。感测电感回路1015可以形成调谐电路的一部分,并且随着感测电感回路1015的阻抗变化可以检测到谐振频率的变化。还可以提供第二参考感应回路1010作为阻抗桥的一部分,以在往复式管状致动构件58在钳口致动期间平移时测量电路阻抗的变化。还应当理解,此类感应感测机构可以反向模式操作,其中当往复式管状致动构件58在钳口致动期间平移时,一个或多个铁电金属带1020可以平移出感测感应回路1015。可以认识到,感应感测机构的输出可以提供往复式管状致动构件58的位置或往复式管状致动构件58的行程量的量度。用于一个或多个感应回路1010、1015的驱动和检测电子器件,包括振荡器和测量电子器件(用于电压、电流或电压和电流两者),可以位于电路板553上。
在另一个方面,如图11A和图11B所描绘,往复式管状致动构件58可包括小管磁体1120。管磁体1120的运动和/或位置可以由霍尔效应传感器1115检测,该霍尔效应传感器定位在往复式管状致动构件58近侧并且固定在柄部组件12内。在另一个方面,管磁体1120可具有在平行于霍尔效应传感器1115的面的线中移动的北极和南极,该霍尔效应传感器可处于固定位置。
霍尔效应传感器1115可包括小电子芯片,该电子芯片可以基于管磁体1120的相对接近度或磁场相对于霍尔效应传感器1115的强度来感测磁场并且改变其电输出。当往复式管状致动构件58沿近侧方向平移时,管磁体1120可越过霍尔效应传感器1115的面移动(箭头,图11A)。如图11B所描绘,在往复式管状致动构件58的行程结束时,如图11B所描绘,管磁体1120可以直接定位于霍尔效应传感器1115的面的前方。
如图11A中的箭头所示,当往复式管状致动构件58沿近侧方向平移(并且钳口改变为闭合状态)时,管磁体1120可以朝向霍尔效应传感器1115平移,从而改变霍尔效应传感器1115的电压输出。还应当理解,此类管磁体感测机构可以反向模式操作,其中当往复式管状致动构件58在钳口致动期间平移时,管磁体1120可以平移远离霍尔效应传感器1115。可以认识到,磁性感测机构的输出可以提供往复式管状致动构件58的位置或往复式管状致动构件58的行程量的量度。用于霍尔效应传感器1115的驱动和检测电子器件,包括电流源和电压测量电子器件,可以位于电路板553上。
在其他方面,如图12至图14所描绘,往复式管状致动构件58可以机械联接至往复式套环1210。往复式套环2010可包括机械地联接到往复式管状致动构件58的近侧端部的远侧凸缘572a。往复式套环1210还可包括机械地联接到往复式套环主体1210并固定在柄部组件12的参考系中的近侧凸缘572b。往复式套环主体1210可被适当地设置,使得往复式管状致动构件58可在往复式套环主体1210上滑动。在一个另选的方面,当使用者压缩触发器32时,往复式轭84可以接合远侧凸缘572a并使远侧凸缘572a与往复式管状致动构件58一起沿近侧方向滑动,如图12A、图13A和图14A中的箭头所描绘。
弹簧堆叠578可围绕远侧凸缘572a与近侧凸缘572b之间的往复式套环主体1210设置。当致动触发器32时,当往复式轭84沿近侧方向平移时,可以压缩弹簧堆叠578。在释放触发器32时,在弹簧堆叠578中由于其压缩而产生的恢复力可导致远侧凸缘572a和联接的往复式管状致动构件58沿远侧方向推进。
在图12A和图12B所描绘的一个方面,远侧凸缘572a可包括小凸缘磁体1220。凸缘磁体1220的运动和/或位置可以由霍尔效应传感器1215检测,该霍尔效应传感器定位在远侧凸缘572a的近侧并且固定在柄部组件12内。在另一个方面,凸缘磁体1220可具有在平行于霍尔效应传感器1215的面的线中移动的北极和南极,该霍尔效应传感器可处于固定位置。
霍尔效应传感器1215可包括小电子芯片,该电子芯片可以基于凸缘磁体1220的相对接近度或磁场相对于霍尔效应传感器1215的强度来感测磁场并且改变其电输出。当远侧凸缘572a沿近侧方向平移时,凸缘磁体1220可越过霍尔效应传感器1215的面移动(箭头,图12A)。如图12B所描绘,在远侧凸缘572a的行程结束时,如图12B所描绘,凸缘磁体1220可以直接定位于霍尔效应传感器1215的面的前方。
如图12A中的箭头所示,当远侧凸缘572a沿近侧方向平移(并且钳口改变为闭合状态)时,凸缘磁体1220可以朝向霍尔效应传感器1215平移,从而改变霍尔效应传感器1215的电压输出。还应当理解,此类凸缘磁体感测机构可以反向模式操作,其中当远侧凸缘572a在钳口致动期间平移时,凸缘磁体1220可以平移远离霍尔效应传感器1215。可以认识到,磁性感测机构的输出可以提供远侧凸缘572a的位置或远侧凸缘572a的行程量的量度。用于霍尔效应传感器1215的驱动和检测电子器件,包括电流源和电压测量电子器件,可以位于电路板553上。
在另一个方面,如图13A、B所描绘,远侧凸缘572a的位置可以由电阻传感器1310确定。电阻传感器1310可包括联接到正电压的第一线性电阻元件1315(由图13A中的“+”表示)和联接到负电压或电接地的第二导电元件1320(由图13A中的“-”表示)。在一个方面,远侧凸缘572a的边圈可以是导电的,并且被构造成能够接触线性电阻元件1315和导电元件1320两者。在另一个方面,远侧凸缘572a可包括导电弧刷1325,该导电弧刷被构造成能够接触线性电阻元件1315和导电元件1320两者。
当远侧凸缘572a沿近侧方向平移时(如图13A中的箭头所示),远侧凸缘572a的导电凸缘或弧刷1325可沿着线性电阻元件1315移动。因此,当远侧凸缘572a处于远侧位置时流过电阻传感器1310的电流的测量值,如图13B所描绘,可以不同于当远侧凸缘572a处于近侧位置时流过电阻传感器1310的电流的测量值,如图13A所描绘。在一个方面,当远侧凸缘572a处于远侧位置时,流过电阻传感器1310的电流可以比远侧凸缘572a处于近侧位置时更大。在另一个方面,当远侧凸缘572a处于近侧位置时,流过电阻传感器1310的电流可以比远侧凸缘572a处于远侧位置时更大。应当理解,远侧凸缘572a的位置或移动量可以由电阻传感器1310测量。用于电阻传感器1310的驱动和检测电子器件,包括电压源和电流测量电子器件,可以位于电路板553上。
在另一个方面,如图14A、B所描绘,远侧凸缘572a的位置可以由光学传感器1410确定。光学传感器1410可包括光源1420诸如LED和光传感器1415。光传感器1415可以被构造成能够产生电流或电压,该电流或电压与由光传感器1415接收来自光源1420的光的量成比例。在一个方面,光源1420和光传感器1415可以设置成允许远侧凸缘572a的边缘在它们之间移动。
当远端凸缘572a沿近侧方向平移时(如图14A中的箭头所示),远侧凸缘572a可以被定位成部分地或完全地遮挡光传感器1415以使其不接收由光源1420发射的光,如图14B所描绘。需注意,因为远侧凸缘572a定位于光传感器1415与光源1420之间,所以在图14B中未示出光传感器1415。因此,当远侧凸缘572a处于远侧位置时来自光传感器1415的电压或电流的测量值,如图14A所描绘,可以不同于远侧凸缘572a处于近侧位置时来自光传感器1415的电压或电流,如图14B所描绘。如图14A、B所描绘,当远侧凸缘572a处于远侧位置时,光传感器1415可接收来自光源1420的照明(图14A),并且当远侧凸缘572a处于近侧位置时,来自光源1420的光可以被远侧凸缘572a从光传感器1415遮挡(图14B)。然而,在另选的实施方案中,当远侧凸缘572a处于近侧位置时,光传感器1415可接收来自光源1420的照明,并且当远侧凸缘572a处于远侧位置时,来自光源1420的光可以被远侧凸缘572a从光传感器1415遮挡(图14B)。
尽管图14A、B描绘了单个光源1420和单个光传感器1415,但是此类传感器构型不是限制性的。例如,多个光源可沿着平行于远侧凸缘572a的行进的轴线以线性阵列布置。类似地,多个光传感器可以沿着c以线性阵列设置,其中多个光传感器中的每个被构造成能够接收来自光源的线性阵列中的一个的照明。远侧凸缘572a在近侧方向或远端方向上传输时行进的距离或位置可以从光传感器中的每个产生的电流或电压的测量值中确定。在一些方面,当远侧凸缘572a阻挡了特定的光传感器时,电流或电压可以具有高值。在其他方面,当远侧凸缘572a阻挡了特定的光传感器时,电流或电压可以具有低值。因此,可以基于光传感器的线性阵列中的哪个具有由于远侧凸缘572a的位置而对应于低光水平的电特性来确定远侧凸缘572a的位置。
在另一个方面,单个光源可以照亮多个光传感器。作为一个非限制性示例,单个光源可包括沿着平行于远侧凸缘572a的行进的轴线设置的电致发光带。用于光学传感器1410的驱动和检测电子器件,包括电压源和电流测量电子器件,可以位于电路板553上。
在图15A和图15B中所描绘的一个方面,弹簧堆叠578可以在弹簧堆叠578的远侧端部包括小弹簧磁体1520。弹簧磁体1520的运动和/或位置可以由霍尔效应传感器1515检测,该霍尔效应传感器定位在弹簧堆叠578的远侧端部的近侧的位置处并且固定在柄部组件12内。在另一个方面,弹簧磁体1520可具有在平行于霍尔效应传感器1515的面的线中移动的北极和南极,该霍尔效应传感器可处于固定位置。
霍尔效应传感器1515可包括小电子芯片,该电子芯片可以基于弹簧磁体1520的相对接近度或磁场相对于霍尔效应传感器1515的强度来感测磁场并且改变其电输出。当压缩弹簧堆叠578时,弹簧磁体1520可朝向霍尔效应传感器1515的面移动(箭头,图15A),并且弹簧堆叠578的远侧端部接近霍尔效应传感器1515。当弹簧堆叠578处于最大压缩时,弹簧磁体1520可以直接定位于霍尔效应传感器1515的面的前面,如图15B所描绘。
如图15A中的箭头所示,当弹簧堆叠578沿近侧方向压缩(并且钳口改变为闭合状态)时,弹簧磁体1520可以朝向霍尔效应传感器1515平移,从而改变霍尔效应传感器1515的电压输出。还应当理解,此类弹簧磁体感测机构可以反向模式操作,其中当在钳口致动期间压缩弹簧堆叠578时,弹簧磁体1520可以平移远离位于弹簧堆叠578的远侧端部的霍尔效应传感器1515。可以认识到,磁性感测机构的输出可以提供弹簧堆叠578的压缩量或压缩程度的量度。用于霍尔效应传感器1515的驱动和检测电子器件,包括电流源和电压测量电子器件,可以位于电路板553上。
如在图5和图10至图15中所描绘的以及以上所公开的,可以采用多个传感器来测量医疗装置10的机械部件的功能。尽管已经明确公开了特定的传感器,诸如压电传感器、电感传感器、电阻传感器、光学传感器和磁性传感器,但是可以认识到,可以使用任何合适的传感器来测量此类机械功能。附加传感器还可包括但不限于电容传感器、磁致伸缩传感器、声学传感器和应变仪传感器。
此类传感器可以任何适当的形式提供与机械功能有关的数据,包括但不限于信号电压、信号电流、阻抗、电阻、信号频率和信号相位。此类数据可包括模拟数据或数字数据,或其组合或组合。此外,由此类传感器提供的数据可以直接涉及此类机械功能,也可以间接涉及此类功能。此外,可以电子方式调节由此类传感器提供的数据,以向使用者提供医疗装置10的部件的机械功能的量度。此类调节电子器件可包括模拟部件、数字部件或其组合或组合。调节电子器件可包括但不限于分立部件,诸如电阻器、电容器和电感器。调节电子器件可包括但不限于集成电路,诸如放大器、比较器和滤波器。调节电子器件还可包括但不限于数字电子组件,诸如ADC、DAC、微处理器、电容器和电感器。应当理解,调节电子器件可包括此类分立部件、集成电路和数字电子部件的任意组合或组合。
如上所述,可以感测到的机械功能可包括但不限于以下任一项或多项:绝对机械位置,一个部件相对于另一个部件的相对机械位置,包括方向、速率和/或部件加速度的机械运动,机械变形(诸如弹簧压缩),施加到部件上的力以及由部件产生的力。
在广义上,可以被感测的机械功能可包括但不限于部件的机械完整性。机械完整性的量度可以提供与部件翘曲、碎裂、开裂、点蚀、断裂或可能不利地影响部件的预期功能的机械磨损和/或损坏的其他指示有关的数据。
在更广泛的意义上,可以被感测的机械功能可包括但不限于部件的存在或不存在。
图16示出了超声医疗装置100的一方面的框图,该超声医疗装置可包括或实现本文描述的许多功能。例如,在一个方面,医疗装置100可以类似于或代表超声医疗装置10。医疗装置100可包括发生器102,该发生器被构造成能够在一个或多个超声换能器104的面上供应电势。超声医疗装置100还可包括超声联接到超声换能器104的超声端部执行器。医疗装置100还可包括控制系统108,该控制系统可控制医疗装置100的任何功能,例如控制发生器102的操作。
控制系统108还可向医疗装置100的使用者提供功能反馈,包括但不限于经由扬声器114的音频反馈和经由一个或多个可视显示器116的视觉反馈。例如,扬声器114可发出指示端部执行器功率的信号。根据各个方面,扬声器114可以发出一系列脉冲声音,其中声音脉冲的频率指示供应给端部执行器的功率的量。除了扬声器114之外或代替该扬声器,该装置可包括视觉显示器116。视觉显示器116可根据任何合适的方法来指示端部执行器功率。例如,视觉显示器116可包括一系列发光二极管(LED),其中端部执行器功率由发光的LED数目来表示。
控制系统108还可以接收来自一组或多组装置电子器件109的数据信号。如上所公开的,此类装置电子器件109可以接收来自任一个或多个装置传感器112的一种或多种类型的电信号。上文相对于图5和图10至图15公开了此类装置传感器及其可能产生的电信号的非限制性示例。装置电子器件109可以将参考医疗装置100的一个或多个机械部件的机械功能和功能的数据传送到控制系统108。在接收到装置电子器件的数据之后,控制系统108可以与使用者就医疗装置100的状态进行通信。
控制系统109可包括处理器装置和一个或多个存储器装置。一个或多个存储器装置可以被构造成能够存储指令,这些指令可以指引处理器装置的一个或多个功能。在一些非限制性示例中,此类指令可以指引处理器装置,以启动一个或多个术前过程,其中处理器与医疗装置100的使用者进行通信。此类术前过程可包括由使用者执行的任一个或多个步骤,诸如压缩医疗装置100的触发器。此类术前过程还可包括由处理器执行的一个或多个步骤,诸如致动一个或多个超声换能器104。术前过程还可包括基于由装置传感器112产生的并且通过装置电子器件109传递到控制系统108的电数据,指引处理器测量或确定医疗装置100的一个或多个机械功能。一旦完成术前过程,控制系统109就可以将术前过程的结果通知给使用者。在一些非限制性方面,控制系统109在从术前过程确定医疗装置100或其部件不能正常工作时,可能会阻止使用者启动医疗装置100的任何一个或多个功能。
在一个非限制性方面,装置电子器件109可以位于设置在医疗装置100的柄部组件内的电路板上(例如,图5中的553)。上文已经公开了此类装置电子器件109的示例。在一个方面,此类装置电子器件109可以电联接到控制系统108,并且可以被构造成能够接收来自装置传感器112的数据信号。然后,装置电子器件109可以基于从装置传感器112处接收的信号将数据传递至控制系统108。在另选方面,如图16中的虚线所示,装置电子器件109可以结合到控制系统108中。在一些方面,控制系统108可以位于医疗装置100的柄部组件内。在另选的方面中,控制系统108可以结合在与医疗柄部组件分开的装置中,诸如在分开的外壳中。分开的外壳还可包括发生器。
如上所公开的,超声医疗装置可包括各种机械和电子部件,由于医疗装置的预期用途,这些机械和电子部件会随着时间的流逝而结垢、磨损和/或破裂。在一些情况下,可能期望将医疗装置送回其原始制造商或制造商授权的第三方,以清洁、修复或替换结垢、磨损或破裂的部件。在一些另选情况下,可能期望让使用者所在设施的人员执行医疗装置部件的清洁、修复和/或替换。可以认识到,使用者所在设施的人员可能不具备拆卸和重新组装医疗装置的专业知识,这可能会影响到部件的清洁、修复或替换。因此,重新组装的医疗装置在使用期间可能不能正常工作。
如上所公开的,超声医疗装置可以被制造成包括用以测试重新组装的医疗装置的各个部件的功能完整性并且在重新组装之后通知使用者该装置是否不能正常工作的功能。此类特征可包括一个或多个传感器(包括与传感器有关的电子期间),这些一个或多个传感器被配置成能够测量医疗装置的机械部件的一个或多个功能。如上所公开的,此类机械部件的示例可包括但不限于超声刀、钳口组件、构造成致动钳口组件的往复式管状致动构件、波导、构造成允许使用者致动往复式管状致动构件的一个或多个部件。如上所公开的,可以在医疗装置中结合多个传感器以测量和/或感测此类机械部件的一个或多个功能。
被构造成能够在重新组装之后确定装置是否不能正常工作的医疗装置的附加特征可包括将由位于医疗装置中的处理器执行的一组或多组指令。这些指令可以体现一种或多种方法来测试医疗装置的正确组装和部件功能。此类指令还可以将此类测试的结果通知给使用者,包括解决重新组装中检测到的故障或异常的建议。此类指令可以任何合适的方式编码以由计算处理器执行。可以将计算处理器结合到被构造成能够控制医疗装置的一个或多个操作的控制模块中。计算处理器可以结合到部件诸如位于医疗装置的柄部中的电路板中。这些指令可以存储在计算处理器可访问的非易失性存储器部件中。此类存储器部件可包括但不限于PROM、ROM、EPROM、EEPROM和闪存存储器中的一个或多个。在一些方面,医疗装置可包括多个计算处理器,它们中的任一个或全部可以执行一个或多个指令,这些指令可以对一种或多种方法进行编码以测试该医疗装置的正确重新组装和部件功能。可将这些方法结合到一个或多个术前过程中,以在医疗用途之前测试医疗装置的功能完整性。
这些方法可包括但不限于:对使用者的指令以操纵装置的一个或多个控件,对处理器装置的指令以接收来自传感器的数据,对处理器的指令以将接收到的传感器数据与一个或多个接受参考值进行比较。根据接收到的传感器数据与接受参考值的比较结果,处理器可以执行另外指令以通知使用者该装置可接受使用或该装置不接受使用。如果处理器执行指令以通知使用者该器械不接受使用,则处理器可以另外执行指令以通知使用者再次重新组装装置,或将装置退还给制造商或制造商授权的设施,以进行另外的清洁、零件修复或零件替换。
出于本文所公开的方法的目的,接受参考值或一批接受参考值可以是指示与通过方法测试的功能相关联的可接受值的值或值范围(例如,表示为值范围的端点)。在一些非限制性方面,此类接受参考值可以表示部件的可接受位置、部件的可接受运动的范围、部件的可接受运动的方向、可接受的测量电压、电流、阻抗、电驱动部件的频率或相位、或施加在部件上或由部件施加的可接受的力或压力。
一个或多个接收参考值或多个值可以是计算的值。一个或多个接受参考值可以是从在医疗装置的制造和/或初始组装期间的部件的测量值得出的值。一个或多个接受参考值或多个值可以被编码或存储在设置在超声医疗装置内的非易失性存储器电子部件中。在由制造商或在修复规程期间由制造商适当授权的第三方制造装置期间,一个或多个接受参考值或多个值可以被编码或存储在设置在超声医疗装置内的非易失性存储器电子部件中。非易失性存储部件可包括但不限于ROM、EPROM、EEPROM、闪存存储器或构造成保留数据的任何其他电子部件。非易失性存储器部件可以物理地设置在医疗装置的任何适当部分中,例如在控制电路、发生器中,或在可以设置在柄部组件12内的一个或多个电路板(例如,图5中的电路板553)中。
下文公开的是过程、规程和/或方法的示例,通过这些过程、规程和/或方法,可以测试医疗装置是否可用于医疗规程。尽管此类过程、规程和/或方法可能旨在执行医疗规程之前使用,可以认识到,在医疗规程的中断期间可以使用至少一些过程、规程和/或方法,以便重新评估医疗装置是否适合继续使用。
此类过程、规程和/或方法可以适当地包括在一个或多个自测试规程或烧机规程中。为了简化下文公开的描述的目的,过程、规程和/或方法可以全部统称为“用于测试医疗装置的方法”。尽管相对于用于测试医疗装置的方法的部件的描述可以特别地与诸如图1至图9所描绘的超声医疗装置相关联,但是可以理解,此类方法也可以适用于测试不包括一个或多个具体命名的部件的医疗装置。还应当理解,此类方法也可以适用于利用诸如图1至图9所描绘的超声医疗装置来测试包括与上文公开的那些机械或功能上相似的部件的医疗装置。
即使下文没有明确描述,这些方法也可以全部由使用者在重新组装的超声波医疗装置与构造成控制医疗装置操作的控制系统或控制模块之间形成适当的电连接来启动,例如,如上文相对于图16所公开的。
用于测试医疗装置的方法的一个方面可包括用于确定在重新组装期间是否已经包括医疗装置的所有部件的方法。例如,使用者有可能重新组装医疗装置10并且省略保护护套80,该保护护套可以使使用者与在波导和/或超声刀中感应出的机械振动隔离。如果使用者试图在没有保护护套80的情况下使用该装置,则使用者可能会经历振动,这会分散使用者的注意力,从而无法正确执行医疗规程。
在一个方面,测试医疗装置以省略保护护套80的方法可以基于所测量的压电换能器的阻抗(例如,图6中的616或图7中的912a、b)。
不受理论的约束,可以认识到,压电换能器的机电联接系数可以和所存储的机械能与换能器的输入电能的比率有关。因此,声学地联接到压电换能器的机械部件的变化(可以认为是换能器上的声学或机械负载)可能会通过存储的机械能的变化对联接系数产生影响。保护护套80可以衰减在波导中感应的振动(例如,图6的678和图7的378)。为了使保护护套80衰减波导中的振动,可以将保护护套80声学地联接到波导。因为波导声学地联接到压电换能器,所以保护护套80继而又可以声学地联接到压电换能器。因此,可以在重新组装超声医疗装置时检测是否存在保护护套作为压电换能器的联接系数的变化。
同样,不受理论的约束,联接系数也可以与压电换能器的谐振和反谐振频率有关。另外应当理解,压电换能器的阻抗可以随谐振和反谐振频率而变。因此,压电换能器的所测量阻抗的变化可以反映压电换能器的联接系数的变化。因此,可以认识到,由于医疗装置的联接系数的变化,在医疗装置的重新组装期间省略保护护套80可能会导致压电换能器的所测量阻抗发生变化。
在一个方面,可以将电阻抗计算为跨压电换能器测得的电压与例如在恒定电流条件下以标称谐振频率由超声发生器供应到压电换能器电流的比率。在一些方面,电路板(例如,图5的553)可以结合被构造成能够测量压电换能器的电压、电流或电压和电流两者的装置电子器件。电子器件还可以根据电流和电压测量值计算阻抗。另选地,电路板可包括被构造成能够将电压、电流和计算出的阻抗中的任一个或多个传输至超声信号发生器21和/或发生器控制器25的电子器件。
图17A至图17D描绘了可以从压电换能器测量的示例性电压和电流图。图17A和图17B分别描绘了可以从用于重新组装的医疗装置的压电换能器处获得的电流对时间和电压对时间的曲线图,其中在重新组装期间适当地包括了保护护套80。图17C和图17D分别描绘了可以从用于重新组装的医疗装置的压电换能器处获得的电流对时间和电压对时间的曲线图,其中在重新组装期间省略了保护护套80。可以认识到,通过提供对波导振动的机械阻尼,保护护套由于其吸收通过波导的机械能的能力而可以减小跨压电换能器的所测量电压。
图18A是描绘方法1800a的流程图,其中如果没有基于压电换能器的阻抗测量值正确地重新组装医疗装置,则可以警告使用者。医疗装置的使用者可能已经拆卸了医疗装置的全部或一部分,以便提供任何类型的维护,包括但不限于清洁、消毒、替换和/或修复一个或多个部件。然后,使用者可以重新组装医疗装置1815,包括但不限于重新组装夹持臂、钳口组件、往复式管状致动构件和轴组件。
在使用者在重新组装的超声医疗装置与控制系统之间形成适当的电连接之后,控制系统可以提示使用者完全按下触发器,从而在超声刀的近侧的位置处夹持钳口组件1820。在例如从触发器传感器的输出处接收到钳口组件被夹持的指示时,控制系统然后可以通过允许发生器向压电换能器供应电流来激活1825压电换能器。应当理解,在测试方法期间供应给压电换能器的电流量可以小于在医疗规程期间通常供应的电流量。在一个示例中,压电换能器可将横向机械波感应到波导中。又如,压电换能器可将非横向机械波感应到波导中。在测试期间,电流可以施加预定的时间量。
在发生器将激活电流供应给压电换能器时,医疗装置的一个或多个电子部件可以测量1830压电换能器的阻抗。应当理解,被构造成能够测量阻抗值的此类电子器件可以被设置在医疗装置柄部组件、控制电路或发生器中。然后,电子部件和/或控制系统或模块可以确定1835,是否所测量的阻抗值在预定的公差极限内。如果所测量的阻抗值在预定的公差极限内,则控制电路可以向使用者提供信号,从而允许1840在临床规程中使用外科装置。此类信号可包括音频信号或视觉信号。音频信号可包括例如蜂鸣器或其他音调以警告使用者。视觉信号可包括发光的LED(例如,红色LED或闪烁的LED)或文本显示器。
如果所测量的阻抗值不在预定的公差极限内,则控制电路可以向使用者提供信号以拆卸和重新组装医疗装置。此类信号可包括音频信号或视觉信号。视觉信号可包括文本显示器。在一个方面,文本显示器可以请求使用者拆卸和重新组装装置。在另一个方面,文本显示器可以建议使用者检查不对准或丢失的部件。在该方面的一个示例中,显示器可以建议使用者进行检查以确保保护护套已经包括在重新组装中。
图18B是描述方法1800b的流程图,其中如果没有基于压电换能器的谐振频率的测量值正确地重新组装医疗装置,则可以警告使用者。医疗装置的使用者可能已经拆卸了医疗装置的全部或一部分,以便提供任何类型的维护,包括但不限于清洁、消毒、替换和/或修复一个或多个部件。然后,使用者可以重新组装医疗装置1815,包括但不限于重新组装夹持臂、钳口组件、往复式管状致动构件和轴组件。
在使用者在重新组装的超声医疗装置与控制系统之间形成适当的电连接之后,控制系统可以提示使用者完全按下触发器,从而在超声刀的近侧的位置处夹持钳口组件1820。在例如从触发器传感器的输出处接收到钳口组件被夹持的指示时,控制系统然后可以通过允许发生器向压电换能器供应电流来激活1825压电换能器。应当理解,在测试方法期间供应给压电换能器的电流量可以小于在医疗规程期间通常供应的电流量。在一个示例中,压电换能器可将横向机械波感应到波导中。又如,压电换能器可将非横向机械波感应到波导中。在测试期间,电流可以施加预定的时间量。
在发生器将激活电流供应给压电换能器时,医疗装置的一个或多个电子部件可以测量1832压电换能器的谐振频率。应当理解,被构造成能够测量谐振频率的此类电子器件可以被设置在医疗装置柄部组件、控制电路或发生器中。例如,控制电路可包括指令以指引发生器产生供应给压电换能器的电流的频率扫描,同时在频率扫描期间另外的电子部件测量压电换能器的阻抗值。应当理解,谐振频率可以对应于阻抗值最小处的频率。然后,电子部件和/或控制系统或模块可以确定1837,是否谐振频率在预定的公差极限内。如果谐振频率在预定的公差极限内,则控制电路可以向使用者提供信号,从而允许1840在临床规程中使用外科装置。此类信号可包括音频信号或视觉信号。音频信号可包括例如蜂鸣器或其他音调以警告使用者。视觉信号可包括发光的LED(例如,红色LED或闪烁的LED)或文本显示器。
如果谐振频率不在预定的公差极限内,则控制电路可以向使用者提供信号以拆卸和重新组装医疗装置。此类信号可包括音频信号或视觉信号。视觉信号可包括文本显示器。在一个方面,文本显示器可以请求使用者拆卸和重新组装装置。在另一个方面,文本显示器可以建议使用者检查不对准或丢失的部件。在该方面的一个示例中,显示器可以建议使用者进行检查以确保波导适当地连接到压电换能器部件。在该方面的另一个示例中,显示器可以建议使用者进行检查以确保超声刀正确地联接到波导。在该方面的又一个示例中,显示器可以建议使用者进行检查以确保超声刀相对于夹持垫适当地间隔开。
可以认识到,可以在相同的测试规程期间一起测量压电换能器阻抗和压电换能器谐振频率。
图19是描述方法1900的流程图,其中如果没有基于从医疗装置的一个或多个部件的机械运动的传感器处接收到的数据来正确地重新组装医疗装置,则可以警告使用者。如上所公开的,可以制造1905超声医疗装置,以结合构造成测量或检测医疗装置的一个或多个机械部件的运动的多个传感器中的任一个。在装置的制造期间,例如作为验证和/或校验规程的一部分,制造商可以在一个或多个非易失性存储器部件中存储1910一个或多个公差极限值。一个或多个公差极限值可以表示从一个或多个传感器处接收的值,并且可以指示基于传感器值的一个或多个机械部件的正确功能。正确功能的值可包括但不限于正确的机械行程、正确的机械位置和正确的施加机械压力。应当理解,公差极限值也可以由制造商授权的修复设施编程到非易失性存储器装置中。然后,使用者可以接收来自制造商或授权设施的新的或翻新的医疗装置。
医疗装置的使用者可能已经拆卸了医疗装置的全部或一部分,以便提供任何类型的维护,包括但不限于清洁、消毒、替换和/或修复一个或多个部件。然后,使用者可以重新组装医疗装置1915,包括但不限于重新组装夹持臂、钳口组件、往复式管状致动构件和轴组件。然后,在临床用途之前,使用者可以将医疗装置附接到1920至控制系统和/或装置发生器。这样,使用者可以在重新组装的超声医疗装置与控制系统之间形成适当的电连接。作为测试方法的一部分,控制系统可以从非易失性存储器处检索1925一个或多个公差极限值。
控制系统可以提示1930使用者完全按下触发器,从而将钳口组件夹持在超声刀的近侧。在一个方面,在例如从触发器传感器的输出处接收到钳口组件被夹持的指示时,控制系统然后可以通过允许发生器向压电换能器供应电流来激活压电换能器。应当理解,在测试方法期间供应给压电换能器的电流量可以小于在医疗规程期间通常供应的电流量。在一个示例中,压电换能器可将横向机械波感应到波导中。又如,压电换能器可将非横向机械波感应到波导中。在测试期间,电流可以施加预定的时间量。
在另一个方面,作为该测试方法的一部分,在例如从触发器传感器的输出处接收到钳口组件被夹持的指示时,控制系统可以不激活压电换能器。
医疗装置的一个或多个电子部件可以测量1935从一个或多个传感器处获得的一个或多个值。应当理解,此类传感器电子器件可以被设置在医疗装置柄部组件、控制电路或发生器中。传感器可以被构造成能够测量用于正确的部件功能的值,该值可包括但不限于正确的机械行程、正确的机械位置和正确的施加机械压力。在一个非限制性示例中,传感器可测量往复式管状致动构件的位移。在另一个非限制性示例中,传感器可测量弹簧堆叠的位移。如上所公开的,此类传感器可包括但不限于电感传感器、电阻传感器、磁性传感器或光学传感器。
然后,电子部件和/或控制系统或模块可以确定1940,是否所测量的往复式管状致动构件的位移或位置在预定的公差极限内。另选地,电子部件和/或控制系统或模块可以确定1942,是否所测量的弹簧堆叠的位移或位置在预定的公差极限内。如果所测量的往复式管状致动构件的位移或位置或所测量的弹簧堆叠的位移或位置在预定的公差范围内,则控制电路可以向使用者提供信号,从而允许1950在临床规程中使用外科装置。此类信号可包括音频信号或视觉信号。音频信号可包括例如蜂鸣器或其他音调以警告使用者。视觉信号可包括发光的LED(例如,红色LED或闪烁的LED)或文本显示器。
如果所测量的往复式管状致动构件的位移或位置或所测量的弹簧堆叠的位移或位置不在预定的公差范围内,则控制电路可以向使用者提供信号,从而拒绝1945该装置的临床用途。控制电路还可以向使用者提供信号,从而建议该装置应当被拆卸和重新组装。此类信号可包括音频信号或视觉信号。视觉信号可包括文本显示器。在一个方面,文本显示器可以请求使用者拆卸和重新组装装置。在另一个方面,文本显示可以建议使用者检查不对准或丢失的部件,诸如弹簧堆和/或往复式管状致动构件。
图20是描述方法2000的流程图,其中如果没有基于从医疗装置的一个或多个部件的机械压力的传感器处接收到的数据来正确地重新组装医疗装置,则可以警告使用者。如上所公开的,可以制造超声医疗装置,以结合构造成测量或检测医疗装置的一个或多个机械部件的运动的多个传感器中的任一个。在装置的制造期间,例如作为验证和/或校验规程的一部分,制造商可以在一个或多个非易失性存储器部件中存储一个或多个公差极限值。一个或多个公差极限值可以表示从一个或多个传感器处接收的值,并且可以指示基于传感器值的一个或多个机械部件的正确功能。正确功能的值可包括但不限于正确的机械行程、正确的机械位置和正确的施加机械压力。应当理解,公差极限值也可以由制造商授权的修复设施编程到非易失性存储器装置中。然后,使用者可以接收来自制造商或授权设施的新的或翻新的医疗装置。
医疗装置的使用者可能已经拆卸了医疗装置的全部或一部分,以便提供任何类型的维护,包括但不限于清洁、消毒、替换和/或修复一个或多个部件。然后,使用者可以重新组装医疗装置,包括但不限于重新组装夹持臂、钳口组件、往复式管状致动构件或触发器组件连杆的任一个或多个部件(例如,图5中的590)。然后,在临床用途之前,使用者可以将医疗装置附接到控制系统和/或装置发生器。这样,使用者可以在重新组装的超声医疗装置与控制系统之间形成适当的电连接。作为测试方法的一部分,控制系统可以从非易失性存储器处检索一个或多个公差极限值。
控制系统可以提示2005使用者完全按下触发器,从而将钳口组件夹持在超声刀的近侧。然后,控制系统可以接收来自触发器传感器(例如,图5中的532)的传感器数据,该触发器传感器被配置成能够测量触发器的位置或确定触发器是否被完全压缩。然后,控制系统可以基于触发器传感器提供的值来确定2010触发器是否被完全压缩。如果触发器传感器指示触发器未完全压缩,则控制系统可再次提示2005使用者完全按下触发器。
如果触发器传感器指示触发器已完全压缩,则控制系统可以接收2015来自力传感器的数据,该数据参考钳口组件对超声刀的夹持力。在一个非限制性示例中,可以基于在压电弹簧力传感器的面之间产生的电压来确定夹持力。在非限制性方面,压电弹簧力传感器可包括设置在轭84与弹簧堆叠578之间的压电盘575(例如,参见图5)。压电弹簧力传感器的面之间的电压可能由于压电弹簧力传感器的压缩而产生。
钳口组件对超声刀的夹持力可以直接与往复式管状致动构件的运动所传递的力有关(例如,参见图4中的58)。由于往复式管状致动构件的运动引起的力继而又可以由轭组件的运动引起(例如,参见图5中的84)。由于使用者通过触发器组件连杆的动作而按下触发器32所施加的力,轭组件可向设置在轭与弹簧堆之间的压电盘施加压缩力(例如,参见图5中的590)。因此,应当理解,可以通过施加到压电盘上的压缩力间接地感测钳口组件对超声刀的夹持力。
如上所公开的,在装置的制造期间,例如作为验证和/或校验规程的一部分,制造商可以在一个或多个非易失性存储器部件中存储一个或多个公差极限值。一个或多个公差极限值可以表示数学模型的值,该数学模型的值与在压电弹簧力传感器的面之间产生的电压和施加到压电弹簧力传感器的压力有关。然后,此类数学模型可以将在压电弹簧力传感器的面之间产生的电压与钳口组件的夹持力关联。
然后,电子部件和/或控制系统或模块可以确定2020,是否夹持力在预定的公差极限内。如果所测量的夹持力在预定的公差极限内,则控制电路可以向使用者提供信号,从而允许2025在临床规程中使用外科装置。此类信号可包括音频信号或视觉信号。音频信号可包括例如蜂鸣器或其他音调以警告使用者。视觉信号可包括发光的LED(例如,红色LED或闪烁的LED)或文本显示器。
夹持力的测量可在一段时间内进行。可以认识到,可以在使用者按下触发器时进行夹持力的测量,并且在测量期间使用者可能不能始终按下触发器。在测量期间,使用者的手指可能会弯曲和/或松弛,因此测得的夹持力可能反映出使用者在测量期间以相同的力按下触发器的能力。因此,如果控制系统确定2020夹持力不在预定的公差范围内,则此确定可能是由于使用者无法在整个测量时间内保持一致的夹持力。对于该测试测量值,可以对控制系统进行编程以提示2005使用者预定的次数以在测试期间按下触发器。在一个非限制性示例中,提示2005使用者按下触发器的预定的次数可包括三次。在其他非限制性示例中,提示2005使用者按下触发器的预定的次数可包括一次、两次、三次、四次、五次或可以确定为适用的任何次数。
在图20中描绘的方面中,控制系统可以确定2030使用者是否已经尝试按下触发器以进行三次力测量测试。如果使用者按下触发器的次数少于三次,则可以提示2035使用者检查装置并且尝试进行新的夹持测试。然而,如果即使在预定次数的力测试(例如,三次夹持测试)之后,所测量的夹持力也不在预定的公差极限内,则控制电路可以向拒绝将该装置用于临床的使用者提供信号。例如,控制信号可提示2040使用者替换装置。另选地,控制信号可以提示使用者拆卸和重新组装装置。在另一个另选方案中,控制信号可以提示使用者将装置发送到由制造商授权的设施,以进行另外的测试、替换和/或修复。
图21是描述方法2100的流程图,其中如果没有基于从医疗装置的一个或多个部件的机械运动的传感器处接收到的数据来正确地重新组装医疗装置,则可以警告使用者。如上所公开的,可以制造超声医疗装置,以结合构造成测量或检测医疗装置的一个或多个机械部件的运动的多个传感器中的任一个。在装置的制造期间,例如作为验证和/或校验规程的一部分,制造商可以在一个或多个非易失性存储器部件中存储一个或多个公差极限值。一个或多个公差极限值可以表示从一个或多个传感器处接收的值,并且可以指示基于传感器值的一个或多个机械部件的正确功能。正确功能的值可包括但不限于正确的机械行程、正确的机械位置和正确的施加机械压力。应当理解,公差极限值也可以由制造商授权的修复设施编程到非易失性存储器装置中。然后,使用者可以接收来自制造商或授权设施的新的或翻新的医疗装置。
医疗装置的使用者可能已经拆卸了医疗装置的全部或一部分,以便提供任何类型的维护,包括但不限于清洁、消毒、替换和/或修复一个或多个部件。然后,使用者可以重新组装医疗装置,包括但不限于重新组装夹持臂、钳口组件、往复式管状致动构件或触发器组件连杆的任一个或多个部件(例如,图5中的590)。然后,在临床用途之前,使用者可以将医疗装置连接2105至控制系统和/或装置发生器。这样,使用者可以在重新组装的超声医疗装置与控制系统之间形成适当的电连接。作为测试方法的一部分,控制系统可以从非易失性存储器处检索一个或多个公差极限值。
控制系统可以提示2110使用者完全按下触发器,从而将钳口组件夹持在超声刀的近侧。在一个方面,在例如从触发器传感器的输出处接收到钳口组件被夹持的指示时,控制系统然后可以通过允许发生器向压电换能器供应电流来激活压电换能器。应当理解,在测试方法期间供应给压电换能器的电流量可以小于在医疗规程期间通常供应的电流量。在一个示例中,压电换能器可将横向机械波感应到波导中。又如,压电换能器可将非横向机械波感应到波导中。在测试期间,电流可以施加预定的时间量。
在另一个方面,作为该测试方法的一部分,在例如从触发器传感器的输出处接收到钳口组件被夹持的指示时,控制系统可以不激活压电换能器。
医疗装置的一个或多个电子部件可以测量2115螺纹管套环的远侧凸缘(例如,图10A中的572a)与螺纹管套环的近侧凸缘(例如,图10A中的572b)之间的距离。应当理解,此类传感器电子器件可以被设置在医疗装置柄部组件、控制电路或发生器中。在一个非限制性示例中,传感器可以测量螺纹管套环的远侧凸缘(例如,图10A中的572a)与螺纹管套环的近侧凸缘(例如,图10A中的572b)之间的距离。如上所公开的,此类传感器可包括但不限于电阻传感器、磁性传感器或光学传感器。
然后,电子部件和/或控制系统或模块可以确定2120螺纹管套环的远侧凸缘与螺纹管套环的近侧凸缘之间的所测量距离是否在预定的公差极限内。如果螺纹管套环的远侧凸缘与螺纹管套环的近侧凸缘之间的所测量距离在预定的公差范围内,则控制电路可以向使用者提供信号,从而允许2125在临床规程中使用外科装置。此类信号可包括音频信号或视觉信号。音频信号可包括例如蜂鸣器或其他音调以警告使用者。视觉信号可包括发光的LED(例如,红色LED或闪烁的LED)或文本显示器。
如果螺纹管套环的远侧凸缘与螺纹管套环的近侧凸缘之间的所测量距离不在预定的公差范围内,则控制电路可以向使用者提供信号,从而不允许2130在临床中使用该装置。控制电路还可以向使用者提供信号,从而建议该装置应当被拆卸和重新组装。此类信号可包括音频信号或视觉信号。视觉信号可包括文本显示器。在一个方面,文本显示器可以请求使用者拆卸和重新组装装置。在另一个方面,文本显示可以建议使用者检查不对准或丢失的部件,诸如弹簧堆、往复式管状致动构件、螺纹管套环或其任何部件。
图22是描绘方法2400的流程图,其中在预运行或烧机协议之前,如果医疗装置没有正确地重新组装,则可以警告使用者。在替换一个或多个部件之后并且在医疗规程中使用该装置之前,可以使用此协议来测试医疗装置。在一些非限制性方面,已被替换的部件必须在装置使用之前烧机。替换部件可能需要烧机协议,该协议可能会随着时间的推移而改变其功能,直到该部件达到稳态功能或形状为止。在一个非限制性示例中,夹持臂组件(例如,图3中的64)的夹持垫(例如,图3中的330)可以被构造成能够在超声刀(例如,图3中的66)与夹持臂(例如,图3中的64)之间接合组织。夹持垫可包括在使用期间与超声刀接触时最初会磨损直至达到稳态形状的材料。可以认识到,在医疗规程期间使用未经过烧机协议的新夹持垫可能会导致结果不一致,直到夹持垫达到稳态形状为止。类似地,新的超声刀或刀的表面可能需要类似的烧机规程,以确保在使用期间该表面不会发生变化。
在装置的制造期间,例如作为验证和/或校验规程的一部分,制造商可以在一个或多个非易失性存储器部件中存储一个或多个公差极限值。在烧机协议的一个方面,一个或多个公差极限值可以表示可以指示部件已经被成功烧机之后的一个或多个医疗装置部件的稳态功能的值。在另一个方面,一个或多个公差极限值可以表示一系列值,这些值可以对应于随着烧机协议进行而对部件功能的已知、测量或预期的变化。应当理解,公差极限值也可以由制造商授权的修复设施编程到非易失性存储器装置中。
医疗装置的使用者可能已经拆卸了医疗装置的全部或一部分,以便提供任何类型的维护,包括但不限于清洁、消毒、替换和/或修复一个或多个部件。然后,使用者可以重新组装医疗装置,包括但不限于重新组装夹持臂、超声刀、波导或夹持垫。然后,在临床用途之前,使用者可以将医疗装置附接到控制系统和/或装置发生器。这样,使用者可以在重新组装的超声医疗装置与控制系统之间形成适当的电连接。作为测试方法的一部分,控制系统可以从非易失性存储器处检索一个或多个公差极限值。
在医疗装置已经连接到控制系统之后,控制系统可以提示2405使用者启动预运行协议。预运行协议可包括内置于自检中的任何数量的医疗装置,以测试与医疗装置相关联的任何数量的机械和/或电子功能。烧机协议可以作为初始预运行协议的一部分而被启动2410。在烧机协议期间,可以提示2415使用者完全按下触发器,从而将钳口组件夹持在超声刀的近侧,并且致动压电换能器。然后,控制系统可以向压电换能器提供电压,这继而又可以在波导中以及最终在刀片中感应出机械波。可以认识到,施加到压电换能器的电压可以小于医疗规程期间通常供应的电压。
因此,系统可以在设定的时间段(烧机时间)中激活2420医疗装置的压电换能器。在一些非限制性示例中,烧机时间可为约四秒。此类烧机时间的另选示例可包括但不限于约2秒、约3秒、约4秒、约5秒、约10秒的烧机时间,或它们之间的一个或多个值的范围,包括端点。在整个烧机时间中,控制系统可以在测量触发器的位置或确定触发器是否被完全压缩时接收来自触发器传感器的传感器数据。然后,控制系统可以确定2425触发器是否在整个烧机期间被完全压缩。可以认识到,使用者可能不会在整个烧机时间内始终按下触发器。使用者的手指可能会弯曲和/或松弛,因此使用者可能无法在整个烧机时间内完全按下触发器。如果触发器传感器指示在整个指定的烧机期间触发器没有被完全压缩,则控制系统可以提示2405使用者重新启动预运行协议。在另选方面,控制系统还可以通知使用者由于触发器压缩中的故障,烧机协议没有完成。此类通知可以是音频通知或视觉通知(诸如发光或闪烁的LED或屏幕显示器上的文本消息)。
在整个烧机期间,除了来自触发器传感器的数据外,控制系统还可以接收参考医疗装置其他功能的数据。在一个非限制性示例中,控制系统可以在压电换能器的致动期间接收来自发生器的电压和电流数据。在一些方面,控制系统与一个或多个另外的电子装置一起可以在烧机期间确定压电换能器的阻抗。另外,发生器可以在烧机时间期间扫描压电换能器的致动频率。这样,控制系统可以在整个烧机时间内测量压电换能器的阻抗或压电换能器的谐振频率。
如以上参考图17和图18所公开的,压电换能器的测量的阻抗和/或谐振频率可以与压电换能器的机电联接系数有关。机电联接系数继而又可以与例如通过与诸如夹持垫的部件的接触而放置在换能器上的声学负载有关。应当理解,在烧机协议期间在夹持垫和/或超声刀上的磨损可能导致换能器上的声学负荷的变化。在烧机期间,夹持垫可能会由超声刀暴露在磨损条件下,从而导致夹持垫的表面最佳地接触超声刀。不受理论的约束,当夹持垫的表面适应于超声刀的运动时,夹持垫可以与超声刀形成更好的接触,从而增加了压电换能器上的声学负荷。声学负载的增加可能导致机电联接系数的增加,这可以通过降低谐振频率来检测。
在烧机时间期间,控制系统可以检测压电换能器的谐振频率的变化,并且监视2430谐振频率随时间的曲线的斜率(即,每单位时间谐振频率的变化)。然后,控制系统可以确定2435谐振频率在烧机时间内的曲线的斜率是否在公差极限值的范围内。如上所公开的,公差极限值可以存储在超声医疗装置中的非易失性存储器部件中。在一些非限制性示例中,公差极限值可以是每单位时间谐振频率的变化的最小值。另选地,公差极限值可以是在烧机协议完成之后的谐振频率的稳态值。
如果每单位时间内谐振频率的变化在公差极限值或数值范围内,则控制系统可以向使用者提供信号,表明烧机协议成功,并且可以允许2440医疗装置的临床用途。此类信号可包括音频信号或视觉信号。音频信号可包括例如蜂鸣器或其他音调以警告使用者。视觉信号可包括发光的LED(例如,发光的LED或闪烁的LED)或文本显示器。如果每单位时间内谐振频率的变化在公差极限值或数值范围内,则控制系统可以向使用者提供信号,表明烧机协议不成功,并且提示2405使用者重新启动预运行协议。应当理解,可能存在预定的最大次数,可以提示使用者重新启动预运行协议。在另一个方面,控制电路可以跟踪使用者重新启动预运行协议的次数,并且如果超过了预运行协议的最大重新启动次数,则可以通知使用者拆卸和重新组装医疗装置。
图23是描述方法2500的流程图,其中如果没有基于从医疗装置的一个或多个部件的机械运动的传感器处接收到的数据来正确地重新组装医疗装置,则可以警告使用者。如上所公开的,可以制造超声医疗装置,以结合构造成测量或检测医疗装置的一个或多个机械部件的运动的多个传感器中的任一个。在装置的制造期间,例如作为验证和/或校验规程的一部分,制造商可以在一个或多个非易失性存储器部件中存储一个或多个公差极限值。应当理解,公差极限值也可以由制造商授权的修复设施编程到非易失性存储器装置中。然后,使用者可以接收来自制造商或授权设施的新的或翻新的医疗装置。
一个或多个公差极限值可以表示从一个或多个传感器处接收的值,并且可以指示基于传感器值的一个或多个机械部件的正确功能。用于正确运行的值可包括但不限于正确的机械运动或正确的机械位置。在一些方面,部件的正确运行可包括部件的适当机械完整性。作为非限制性示例,波导和/或超声刀的机械完整性可以指具有适当尺寸和/或形状并且没有物理缺陷诸如凹坑、裂缝或裂纹的波导和/或超声刀。
医疗装置的使用者可能已经拆卸了医疗装置的全部或一部分,以便提供任何类型的维护,包括但不限于清洁、消毒、替换和/或修复一个或多个部件。然后,使用者可以重新组装医疗装置,包括但不限于重新组装机械联接到波导的压电换能器、波导或超声刀。然后,在临床用途之前,使用者可以将医疗装置连接到控制系统和/或装置发生器。这样,使用者可以在重新组装的超声医疗装置与控制系统之间形成适当的电连接。作为测试方法的一部分,控制系统可以从非易失性存储器处检索一个或多个公差极限值。
控制系统可以提示2505使用者启动预运行协议。在一个方面,可以提示使用者按下触发器,从而将钳口组件夹持在超声刀的近侧。在例如从触发器传感器的输出处接收到钳口组件被夹持的指示时,控制系统然后可以通过允许发生器向压电换能器供应电流来激活压电换能器。在另一个方面,不提示使用者按下触发器以将钳口组件夹持在超声刀的近侧。例如,此类方面对于缺少夹持钳口组件的超声医疗装置可能是合适的。在此类预运行协议中,在提示2505使用者启动预运行协议之后,控制系统可以激活2510一个或多个压电换能器,并且控制系统可以允许发生器向一个或多个压电换能器供应电流。应当理解,在测试方法期间供应给一个或多个压电换能器的电流量可以小于在医疗规程期间通常供应的电流量。
如以上相对于图9所公开的,预运行协议的一个示例可以与包括多个压电换能器的超声医疗装置一起使用。图9示出了一个方面,其中波导机械联接到第一侧上的第一换能器和第二相对侧上的第二换能器。此外,第一换能器可包括第一换能器板的第一平面阵列,并且第二换能器可包括第二换能器板的第二平面阵列。如图9所示,第一换能器可包括第一换能器板的第一平面阵列,其由数字1、2、3和4表示。第二换能器可包括第二换能器板的第二平面阵列,其由括号(5)、(6)、(7)和(8)中的数字表示。
图9所描绘的每个换能器或换能器板可以被单独激活。在一些方面,每个换能器或换能器板可以由单独的超声信号发生器激活,其中各个超声信号发生器具有与声学组件电通信的公共接地。在此类方面,每个换能器或换能器板可以通过分开的电信号来激活。在一些示例中,分开的电信号的电特性可以是相同的,例如具有相同的振幅、频率和相位。在另选的示例中,分开的电信号的电特性可以在振幅、频率和相位中的一个或多个方面不同。在另选的方面中,每个换能器或换能器板可以由相同的超声信号发生器激活,但是可以由一个或多个换能器激活开关分别激活。此类开关可以将超声信号的第一极性指引一组换能器或换能器板,并且将超声信号的第二极性指引第二组换能器或换能器板。
此外,如相对于图9所公开的,换能器或换能器板的切换激活可以导致外科工具的振动图案,该振动图案比单个横向机械驻波更复杂。此类复杂的机械波可用于将复杂的移动赋予超声医疗装置的端部执行器。例如,相对于图9所示的方面,如果用第一极性超声信号激活换能器板1、2、(5)和(6),而用第二和相对极性超声信号激活换能器板3、4、(7)和(8),则在端部执行器中可能会感应出主要的横向摇摆运动。如果用第一极性超声信号激活换能器板1、(5)、3和(7),而用第二和相对极性超声信号激活换能器板2、(6)、4和(8),则在端部执行器中可能会感应出主要的横向钩挂运动。如果用第一极性超声信号激活换能器板1、(7)、2和(8),而用第二和相对极性超声信号激活换能器板3、(5)、4和(6),则在端部执行器中可能会感应出主要的扭动运动。如果用第一极性超声信号激活换能器板1、(7)、4和(6),而用第二和相对极性超声信号激活换能器板(5)、3、2和(8),则在端部执行器中可能会感应出扭动和横向运动的组合。可以通过激活其他批换能器板来实现另外的运动。另选地,每个压电换能器或换能器板可以被单独激活。
对于包括以上相对于图9所公开的压电换能器的超声医疗装置,预运行协议可包括控制系统的指令,以激活2510多个压电换能器或换能器板中的任一个或多个,或此类激活的任何顺序以在波导和/或超声刀中感应出各种运动中的任一个。因此,如上所公开,预运行协议可包括激活换能器板以便在波导和超声刀中感应出扭动运动的指令。预运行协议可包括激活换能器板以便在波导和超声刀中感应出摇摆运动的指令。预运行协议可包括激活换能器板以便在波导和超声刀中感应出钩挂运动的指令。预运行协议可包括在波导和/或超声刀中感应出任一个或多个运动所需的换能器板激活的任一序列或序列。
在任一组换能器板的激活2510期间,控制系统可以测量2515一个或多个指示波导和/或超声刀功能和/或性能的信号。在一个非限制性示例中,超声刀性能的测量2515可以基于换能器板的阻抗测量。如上所述,阻抗测量值可以与机电联接常数有关,该机电联接常数可以与波导和/或超声刀存储机械能的能力有关。如果在波导、超声刀或超声刀与波导的联接中发现任何机械缺陷,则可以改变波导和/或超声刀存储机械能的能力。在另一个非限制性示例中,超声刀性能的测量2515可以基于换能器板的谐振频率的测量值。如上所述,谐振频率可以与机电联接常数有关,该机电联接常数可以与波导和/或超声刀存储机械能的能力有关。在又一个非限制性示例中,超声刀性能的测量2515可以基于在压电板的激活期间波导和/或超声刀的位移的光学测量值。在又另一个非限制性示例中,超声刀性能的测量2515可以基于在压电板的激活期间波导和/或超声刀的位移的感应测量值,其中波导和/或超声刀设置在螺线管检测系统内。此类电感测量值可以基于螺线管内的振动簧片的运动。尽管本文中未明确公开,但是在激活一个或多个压电换能器或换能器板期间,波导和/或超声刀的移动的另外感测机构也可以用于测量波导和/或超声刀的功能和/或性能。该控制系统可包括指令,以在一个或多个压电换能器或换能器板的任何激活期间存储波导和/或超声刀的功能和/或性能的测量值。
然后,控制系统可以确定2520是否所有压电换能器和/或换能器板段都已被激活。该确定可包括确定是否已经运行了在波导和/或超声刀中感应出一个或多个运动所需的所有换能器板激活序列。如果在控制系统中编程的换能器板激活的所有序列未运行,则控制器可激活2510激活板的下一序列。
如果在控制系统中编程的所有换能器板激活序列已经运行,则控制器可以确定2525所测量的刀片性能是否在预定的公差范围内,然后控制电路可以向使用者提供信号,以允许2535在临床规程中使用该外科装置。此类信号可包括音频信号或视觉信号。音频信号可包括例如蜂鸣器或其他音调以警告使用者。视觉信号可包括发光的LED(例如,红色LED或闪烁的LED)或文本显示器。
另选地,如果所测量的刀片性能不在预定的公差极限内,则控制电路可以向使用者提供不要在临床规程中使用外科装置的信号。此类信号可包括音频信号或视觉信号。音频信号可包括例如蜂鸣器或其他音调以警告使用者。视觉信号可包括发光的LED(例如,红色LED或闪烁的LED)或文本显示器。在一个非限制性方面,控制电路可以提示2530使用者替换超声刀、波导或超声刀和波导两者。
如上所公开的,在医疗规程的过程期间,超声医疗装置可能被生物材料污染。在一些方面,结垢可包括来自患者的组织或流体,该组织或流体变得附接于已经与患者接触的超声医疗装置的部分。在一些示例中,在超声医疗装置的端部上可以观察到组织或流体。在此类示例中,在该规程期间可以容易地清洁超声医疗装置的端部。然而,在一些示例中,组织或流体可能积聚在细长轴组件的内部,并且可能不容易观察到。例如,组织或流体可以接触波导或超声刀。可以认识到,与波导和/或超声刀接触的此类组织或流体可以减少在其中感应出的机械振动。因此,由于积聚的组织或流体,超声刀的运动可能受到阻碍。
图24描绘了超声医疗装置的一个方面,其中组织和/或流体材料2290已经积聚在细长轴组件2256内,接触波导2278并且潜在地阻止超声刀2266正常工作。本文已经公开了超声医疗装置的许多方面,其包括构造成将组织夹持在超声刀上以允许切割组织的钳口或夹持臂组件(例如,图3中的64)。然而,超声医疗装置的另选方面可包括没有夹持臂或钳口的超声刀。图24描绘了此类装置。
确定组织和/或流体材料2290是否已在此类医疗装置的细长轴组件2256内积聚的方法可以基于测量从超声医疗装置的导电波导2278流到该装置的细长轴的导电且接地的内表面2269的电流。例如,导电波导2278可以电联接到第一触点2240,该第一触点电联接到电流源。类似地,细长轴组件2256的导电内表面2269可以电联接至第二触点2242,该第二触点继而又可以电联接至电接地以接收电流。
不受理论的约束,可以认识到生物组织或流体(或任何水性流体)可以传导电流。因此,从导电波导2278流到超声医疗装置的导电内表面2269的电流可以指示导电生物材料,诸如水、生物流体或生物组织2290可以设置在细长轴组件2256的导电内表面2269上并且与导电波导2278电接触。
应当理解,使用者可以容易地观察到医疗装置的远侧端部处的组织和/或流体2290的积聚,因此使用者可以在医疗规程中移除观察到的材料。然而,沉积在细长轴组件2256内部的材料2290可能不容易观察到,因此使用者可能不知道此类材料2290已经积聚。因此,用于检测此类医疗装置中材料2290积聚的电子方法可能需要一些功能,这些功能会阻止该方法发出易于观察的材料的假阳性指示。
在一个非限制性示例中,细长轴2256可包括非导电材料的包覆模制,该非导电材料也可部分地设置在细长轴的内部远侧端部中。电绝缘包覆模制材料的内部边缘2270可以从细长轴2256的远侧边缘沿近侧方向延伸。电绝缘包覆模制材料的内部边缘2270的近侧的导电内表面2269的部分将是未涂覆的,并且因此是导电的。
类似地,超声刀2266可包括导电材料,并且可以电联接到导电波导2278。超声刀2266还可包括电绝缘涂层2267,其从超声刀2266的远侧端部沿近侧方向延伸。在一个非限制性示例中,超声刀2266上的绝缘涂层2267的近侧边缘2279可以设置在细长轴2256的电绝缘包覆模制材料的内部边缘2270的远侧。
因此,设置在超声医疗装置的远侧端部的任何积聚的材料—对于医疗装置的使用者而言都是容易看到的—可能会接触电绝缘材料(包覆模制或超声刀涂层2267),并且因此将无法传导电流。然而,更接近地设置在细长轴2256的内部中的材料2290可以接触导电波导2278和细长轴2256的导电内表面2269两者。这样,确定细长轴2256内材料2290的存在的方法可以基于对导电波导2278与医疗装置的导电内表面2269之间的电流的测量。
图25是描绘方法2300的流程图,其中可以警告使用者是否生物材料或流体已经积聚在诸如图24中所描绘的医疗装置的细长轴组件的内部中。可以将超声医疗装置制造为结合有多个传感器中的任一个,这些传感器被配置成能够测量导电波导与医疗装置的细长轴的导电和接地内表面之间的电流。在装置的制造期间,例如作为验证和/或校验规程的一部分,制造商可以在一个或多个非易失性存储器部件中存储一个或多个公差极限值。
如上所公开的,医疗装置的细长轴内的所积聚材料可导致电流在导电波导与细长轴的电接地内表面之间流动。公差极限值可包括最小电流流值。被测量为大于最小电流的电流可以指示在细长轴组件内积聚的材料。应当理解,公差极限值也可以由制造商授权的修复设施编程到非易失性存储器装置中。
医疗装置的使用者可能已经拆卸了医疗装置的全部或一部分,以便提供任何类型的维护,包括但不限于清洁、消毒、替换和/或修复一个或多个部件。然后,使用者可以连接2310医疗装置的部件,包括但不限于重新组装夹持臂、钳口组件、波导或超声刀。然后,在临床用途之前,使用者可以将医疗装置连接到控制系统和/或装置发生器。这样,使用者可以在重新组装的超声医疗装置与控制系统之间形成适当的电连接。作为测试方法的一部分,控制系统可以从非易失性存储器处检索一个或多个公差极限值。
当系统未与患者接触时,控制系统可以提示2315使用者激活电联接到医疗装置的导电波导的电流源。在一些方面,医疗装置可以由使用者保持,使得医疗装置的远侧端部在空气中。应当理解,医疗装置可包括在医疗装置的柄部上的使用者操作的控件,该控件被构造成能够激活电流源。在测试期间,电流可以施加预定的时间量。在一个方面,电流源可以设置在医疗装置的柄部组件内。在另一方面,电流源可以设置在柄部外部的部件中,例如在功率发生器中。
医疗装置的一个或多个电子部件可以测量2320从导电波导流到细长轴组件的接地内导电表面的电流。应当理解,此类传感器电子器件可以被设置在医疗装置柄部组件、控制电路或发生器中。被构造成能够测量2320电流的电子部件可包括任何此类电子部件,包括但不限于电阻器、电容器、电感器以及集成电路诸如放大器和比较器。
然后,电子部件和/或控制系统或模块可以确定2325在导电波导与细长轴组件的接地导电内表面之间的所测量电流是否大于预定的公差极限。如果所测量的电流小于预定的公差极限,则控制电路可以向使用者提供信号,从而允许2330在临床规程中使用外科装置。此类信号可包括音频信号或视觉信号。音频信号可包括例如蜂鸣器或其他音调以警告使用者。视觉信号可包括发光的LED(例如,红色LED或闪烁的LED)或文本显示器。
如果所测量的电流大于预定的公差极限,则控制电路可以提示2335使用者拆卸医疗装置以重新清洁和/或重新消毒超声刀和/或导电波导。控制电路可以发出任何信号以提示使用者重新清洁和/或重新消毒医疗装置。此类信号可包括音频信号或视觉信号。视觉信号可包括文本显示器。
上文公开的是超声医疗装置的许多特征部,其可能与确定已经由使用者组装或重新组装的医疗装置是否处于在医疗规程期间使用的可接受条件的方法有关。尽管已经相对于特定装置公开了特定特征部,但是可以认识到,此类特征部以及所参考的装置不限于以上公开的方面。
超声医疗装置的拆卸和重新组装可包括整个医疗装置或医疗装置的一个或多个零件的拆卸和重新组装。由使用者拆卸和重新组装的一个或多个零件可包括一个或多个离散零件和/或一个或多个零件子组件。一个或多个子组件还可被拆卸并且重新组装为一个或多个组成零件。由使用者拆卸和重新组装的一个或多个零件可包括一个或多个机械零件、一个或多个机电零件、一个或多个电子零件或其任何组合或组合。可以通过使用一种或多种工具的任何适当方式来完成拆卸和重新组装。另选地,拆卸和重新组装可以通过手工完成,而不需要任何工具。
超声医疗装置可包括机械联接到波导的一个或多个压电换能器。压电换能器可以相对于波导包括任何数量、类型或设置。压电换能器可以在任何机械模式下操作,该机械模式被构造成能够向波导施加超声机械波,包括但不限于D31模式和D33模式。一个或多个压电换能器可以例如通过粘合剂机械地固定到波导。另选地,一个或多个压电换能器可以被结合到压电换能器组件中,该压电换能器组件包括压电换能器和被构造成能够将超声机械波指引到波导中的另选部件。可以将此类压电换能器组件构造成由使用者拆卸和重新组装。压电换能器组件可以可逆地机械联接到波导。
波导继而又可以机械联接到超声刀或刀片。此类机械联接可包括被构造成能够允许将超声机械波从波导传递到超声刀或刀片的任何机械联接。在一些方面,波导和超声刀或刀片可包括分开的部件,其可通过任何机械手段机械联接,包括但不限于焊接、螺柱或粘合剂。在一些另选方面,波导和超声刀或刀片可包括单个部件。
在一些方面,超声医疗装置可包括钳口组件或夹具,该钳口组件或夹具被构造成能够使一块组织在超声刀或刀片近侧以进行切割。钳口组件或夹具可由沿往复式线性或轴向方向移动的一个或多个部件致动。尽管以上公开的方面针对设置在外轴组件内并与外轴组件同轴的往复式管布件,但是应当理解,可以使用任一个线性往复式部件或多个部件来致动钳口组件或夹具。可用于致动钳口组件或夹具的线性往复式部件的另选示例可包括但不限于,往复式杆、一根或多根往复式线和一根或多根往复式带。因此,以上所公开的可以用于检测和/或测量往复式管部件的线性位移的传感器可以等同地用于检测和/或测量可构造成致动钳口组件或夹具的任何其他线性往复式部件的线性位移。可以认识到,除了以上所公开的传感器以外,其他传感器也可以结合在超声医疗装置中,该超声医疗装置包括一个或多个另选的线性往复式部件以致动钳口组件或夹具。
在以上公开的方面中,往复式管部件的运动通过使用者经由包括触发器组件连杆的多个机械部件对触发器的压缩来指引。在以上公开的方面中,触发器的压缩可引起往复式管组件沿近侧方向移动,从而使钳口组件或夹具将组织带到超声刀或刀片的近侧。在另选的方面中,触发器的压缩可引起往复式管组件沿远侧方向移动,从而使钳口组件或夹具将组织带到超声刀或刀片的近侧。可包括合适的触发器组件连杆,以在触发器被压缩时引起此类远侧运动。
在压缩触发器时,可以设置一个或多个弹簧组件以存储机械能。当触发器的压缩被移除时,在一个或多个弹簧组件中存储的机械能可以操作以将往复式管组件的位置恢复到初始位置。在上文描绘的方面中,此类弹簧组件可包括设置在往复式套环的远侧凸缘与近侧凸缘之间的弹簧堆叠。此类弹簧堆叠可包括波形弹簧,如图5所描绘。可将另选的弹簧组件设置在被构造成能够将往复式管组件的位置恢复到初始位置的任何部件中。此类弹簧的附加示例可包括但不限于螺旋状弹簧、片簧和螺旋弹簧。以上所公开的可以用于检测和/或测量弹簧的位移或存储在弹簧中的恢复力的量的传感器可以等同地用于对于任何另选的弹簧组件,检测和/或测量弹簧的位移或存储在弹簧中的恢复力的大小。可以认识到,除了以上所公开的传感器以外,其他传感器也可以结合在超声医疗装置中,该超声医疗装置包括一个或多个另选的弹簧组件,该弹簧组件设置成将往复式管组件恢复到初始位置。
此外,在一些其他方面,超声医疗装置可缺乏钳口组件或夹具,该钳口组件或夹具被构造成能够使一块组织在超声刀或刀片近侧以进行切割。因此,此类超声医疗装置可能缺少被构造成能够移动钳口组件或夹具的那些部件,并且可以类似地不包括被构造成能够检测和/或测量此类部件的位移的传感器。
用于测试或烧机重新组装的医疗装置的方法可以是完全自动化或部分自动化的。在装置使用者致动结合在医疗装置的柄部或医疗装置控制器中的开关或其他控制装置之后,可以致动全自动测试方法。在另一个方面,可以在装置加电时启动全自动测试方法。在另一个方面,部分自动化的测试方法可能需要使用者方面的附加动作,诸如压缩触发器以致动钳口组件。
虽然在上述具体实施方式中列出了各种细节,但是应当理解,用于操作用于数字地生成电信号波形的发生器和外科装置的技术的各个方面,可在没有这些具体细节的情况下实践。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。
此外,尽管已举例说明和描述了多个形式,但是申请人的意图并非将所附权利要求的范围约束或限制在此类细节中。在不脱离本公开的范围的情况下,可实现对这些形式的许多修改、变化、改变、替换、组合和等同物,并且本领域技术人员将想到这些形式的许多修改、变化、改变、替换、组合和等同物。此外,另选地,可将与所描述的形式相关联的每个元件的结构描述为用于提供由所述元件执行的功能的器件。另外,在公开了用于某些部件的材料的情况下,也可使用其他材料。因此,应当理解,上述具体实施方式和所附权利要求旨在涵盖属于本发明所公开的形式范围内的所有此类修改形式、组合和变型形式。所附权利要求旨在涵盖所有此类修改、变化、改变、替换、修改和等同物。
为了公开的简洁和清楚,已经以框图形式而不是详细地描绘了前述公开的所选方面。本文所提供的详细描述的一些部分可根据对存储在一个或多个计算机存储器或一个或多个数据存储装置(例如软盘、硬盘驱动器、光盘(CD)、数字视频磁盘(DVD)或数字磁带)中的数据进行操作的指令来呈现。本领域的技术人员用此类描述和表达向本领域的其他技术人员描述和传达他们的工作要旨。一般来讲,算法是指导致所需结果的有条理的步骤序列,其中“步骤”是指物理量和/或逻辑状态的操纵,物理量和/或逻辑状态可以(但不一定)采用能被存储、转移、组合、比较和以其他方式操纵的电或磁信号的形式。常用于指这些信号,如位、值、元素、符号、字符、术语、数字等。这些和类似的术语可与适当的物理量相关联并且仅仅是应用于这些量和/或状态的方便的标签。
除非上述公开中另外明确指明,否则可以理解的是,在上述公开中,使用术语诸如“处理”或“估算”或“计算”或“确定”或“显示”等的讨论是指计算机系统或类似的电子计算装置的动作和进程,其操纵表示为计算机系统的寄存器和存储器内的物理(电子)量的数据并将其转换成相似地表示为计算机系统存储器或寄存器或其他此类信息存储、传输或显示装置内的物理量的其他数据。
在一般意义上,本领域的技术人员将会认识到,可以用多种硬件、软件、固件或它们的任何组合单独和/或共同实施的本文所述的多个方面可以被看作是由多种类型的“电子电路”组成。因此,如本文所用,“电子电路”包括但不限于具有至少一个离散电路的电子电路、具有至少一个集成电路的电子电路、具有至少一个专用集成电路的电子电路、形成由计算机程序构造的通用计算装置的电子电路(例如,至少部分地实施本文所述的方法和/或装置的由计算机程序构造的通用计算机,或至少部分地实施本文所述的方法和/或装置的由计算机程序构造的微处理器)、形成存储器装置(例如,形成随机存取存储器)的电子电路,和/或形成通信装置(例如,调制解调器、通信开关或光电设备)的电子电路。本领域的技术人员将会认识到,可以模拟或数字方式或它们的一些组合实施本文所述的主题。
上述具体实施方式已通过使用框图、流程图和/或示例阐述了装置和/或方法的各种形式。只要此类框图、流程图和/或示例包含一个或多个功能和/或操作,本领域的技术人员就要将其理解为此类框图、流程图和/或示例中的每个功能和/或操作都可以单独和/或共同地通过多种硬件、软件、固件或实际上它们的任何组合来实施。在一种形式中,本文所述的主题的若干部分可以通过专用集成电路(ASIC)、现场可编程门阵列(FPGA)、数字信号处理器(DSP)或其他集成格式来实施。然而,本领域的技术人员将会认识到,本文所公开的形式的一些方面可以作为在一台或多台计算机上运行的一个或多个计算机程序(如,作为在一个或多个计算机系统上运行的一个或多个程序),作为在一个或多个处理器上运行的一个或多个程序(如,作为在一个或多个微处理器上运行的一个或多个程序),作为固件,或作为实际上它们的任何组合全部或部分地在集成电路中等效地实现,并且根据本发明,设计电子电路和/或编写软件和/或硬件的代码将在本领域技术人员的技术范围内。另外,本领域的技术人员将会认识到,本文所述主题的机制能够作为多种形式的一个或多个程序产品进行分布,并且本文所述主题的示例性形式适用,而不管用于实际进行分布的信号承载介质的具体类型是什么。信号承载介质的示例包括但不限于如下:可录式媒体,诸如软盘、硬盘驱动器、光盘(CD)、数字视频光盘(DVD)、数字磁带、计算机存储器等;和传输式介质,诸如数字和/或模拟通信介质(例如,光纤缆线、波导、有线通信链路、无线通信链路(例如,发射器、接收器、传输逻辑、接收逻辑等)等)。
在一些情况下,一个或多个元件可使用表达“联接”和“连接”连同其衍生词来描述。应当理解,并不希望这些术语彼此同义。例如,某些方面可使用术语“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“联接”还可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。应当理解,包含在不同的其他部件内或与不同的其他部件连接的不同部件的所描绘的架构仅仅是示例,并且实际上可实现许多其他架构以实现相同的功能。在概念意义上,获得相同功能性的部件的任何布置都是有效“相关联的”,使得获得期望的功能性。因此,本文中为获得特定功能性而结合在一起的任何两个部件都可被视为彼此“相关联”,使得获得期望的功能性,而不论结构或中间部件如何。同样,如此相关联的任何两个部件也可视为彼此“操作地连接”或“操作地联接”,以实现期望的功能性,并且能够如此相关联的任何两个部件都可视为彼此“可操作地联接”,以实现期望的功能性。可操作耦接的具体示例包括但不限于物理上可匹配和/或物理上相互作用的部件,和/或可无线交互的,和/或无线相互作用的部件,和/或逻辑上相互作用的,和/或可在逻辑上相互作用的部件,和/或电气相互作用的部件,和/或可电气相互作用的部件,和/或光学相互作用的部件,和/或可光学相互作用的部件。
在其他情况下,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/可操作以”、“适于/可适于”、“能够”、“可适形/适形于”等。本领域的技术人员将会认识到,除非上下文另有所指,否则“被构造成能够”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。
虽然已经描绘并描述了本公开的特定方面,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,如果所引入权利要求叙述的具体数目为预期的,则这样的意图将在权利要求中明确叙述,并且在不存在这样的叙述的情况下,不存在这样的意图。例如,为有助于理解,下述所附权利要求可含有对介绍性短语“至少一个”和“一个或多个”的使用以引入权利要求。然而,对此类短语的使用不应视为暗示通过不定冠词“一个”或“一种”引入权利要求表述将含有此类引入权利要求表述的任何特定权利要求限制在含有仅一个此类表述的权利要求中,甚至当同一权利要求包括介绍性短语“一个或多个”或“至少一个”和诸如“一个”或“一种”(例如,“一个”和/或“一种”通常应解释为意指“至少一个”或“一个或多个”)的不定冠词时;这也适用于对用于引入权利要求表述的定冠词的使用。
另外,即使明确表述引入权利要求表述的特定数目,本领域的技术人员应当认识到,此种表述通常应解释为意指至少表述的数目(例如,在没有其他修饰语的情况下,对“两个表述”的裸表述通常意指至少两个表述、或两个或更多个表述)。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,此类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,此类结构意在具有本领域的技术人员将理解所述惯例的意义(例如,“具有A、B或C中的至少一者的系统”应当包括但不限于具有仅A、仅B、仅C、A和B一起、A和C一起、B和C一起和/或A、B和C一起等的系统)。本领域的技术人员还应当理解,通常,除非上下文另有指示,否则无论在具体实施方式、权利要求或附图中呈现两个或更多个替代术语的转折性词语和/或短语应理解为涵盖包括所述术语中的一者、所述术语中的任一个或这两个术语的可能性。例如,短语“A或B”通常将被理解为包括“A”或“B”或“A和B”的可能性。
对于所附的权利要求,本领域的技术人员将会理解,其中表述的操作通常可以任何顺序进行。另外,尽管以一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。
值得一提的是,任何对“一个方面”、“一方面”、“一种形式”、“一形式”的提及均意指结合该方面所述的具体特征、结构或特性包括在至少一个方面中。因此,出现在整篇说明书中的不同位置中的短语“在一个方面”、“在一方面”、“在一种形式中”或“在一形式中”不一定都是指同一方面。此外,具体特征、结构或特性可在一个或多个方面中以任何合适的方式组合。
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。
在某些情况下,对系统或方法的使用可发生在一个地区中,即使部件位于所述地区外部。例如,在分布式计算上下文中,对分布式计算系统的使用可发生在一个地区中,即使所述系统的部件可能位于所述地区外部(例如,位于所述地区外部的继电器、服务器、处理器、信号承载介质、传输计算机、接收计算机等)。
系统或方法的销售同样可发生一个地区中,即使所述系统或方法的部件位于和/或用于所述地区外部。此外,在一个地区中实施用于执行方法的系统的至少一部分不排除在另一个地区中使用所述系统。
上述美国专利、美国专利申请公开、美国专利申请、国外专利、国外专利申请、本说明书中所提及和/或任何应用数据表中所列出的非专利申请或任何其他公开材料均在不与其相抵触的程度上以引用方式并入本文。因此,并且在必要的程度下,本文明确列出的公开内容代替以引用方式并入本文的任何冲突材料。据称以引用方式并入本文但与本文列出的现有定义、陈述或其他公开材料相冲突的任何材料或其部分,将仅在所并入的材料与现有的公开材料之间不产生冲突的程度下并入。
概括地说,已经描述了由采用本文所述的概念产生的许多有益效果。为了举例说明和描述的目的,已经提供了一个或多个形式的上述具体实施方式。这些具体实施方式并非意图为详尽的或限定到本发明所公开的精确形式。可以按照上述教导内容对本发明进行修改或变型。选择和描述的一个或多个形式是为了说明原理和实际应用,从而使本领域的普通技术人员能够利用适用于预期的特定用途的所述多个形式和多种修改形式。与此一同提交的权利要求书旨在限定完整范围。
本文所述主题的各个方面在以下编号的实施例中陈述:
实施例1.一种管理可重复使用的超声医疗装置的方法,所述方法包括:
由超声医疗装置控制模块接收来自由使用者重新组装的超声医疗装置的电连接;
由所述超声医疗装置控制模块提示所述使用者操作钳口控制部件,所述钳口控制部件被构造成能够闭合所述重新组装的超声医疗装置的端部执行器的钳口;
由所述超声医疗装置控制模块接收来自设置在所述超声医疗装置内的闭合传感器的闭合数据,所述闭合数据指示所述端部执行器的所述钳口处于闭合构型;
由所述超声医疗装置控制模块接收来自所述超声医疗装置的功能数据,所述功能数据参考所述重新组装的超声医疗装置的至少一个部件的功能状态;
由所述超声医疗装置控制模块将所述功能数据的值与一个或多个预定的接受参考值进行比较;以及
由所述超声医疗装置控制模块基于所述功能数据的所述值与所述一个或多个预定的接受参考值的所述比较,向所述使用者提供可接受性指示。
实施例2.根据实施例1所述的方法,其中,接收来自由使用者重新组装的超声医疗装置的电连接包括接收来自超声医疗装置的电连接,所述超声医疗装置具有由所述使用者重新清洁或重新消毒的至少一个部件。
实施例3.根据实施例1或实施例2中的任一项所述的方法,其中,接收来自由使用者重新组装的超声医疗装置的电连接包括接收来自超声医疗装置的电连接,所述超声医疗装置具有至少一个修复部件。
实施例4.根据实施例1至实施例3中的任一项所述的方法,其中,接收来自由使用者重新组装的超声医疗装置的电连接包括接收来自超声医疗装置的电连接,所述超声医疗装置具有至少一个替换部件。
实施例5.根据实施例1至实施例4中的任一项所述的方法,还包括由所述超声医疗装置控制模块确定所述功能数据的所述值在所述接受范围内,并且
其中基于所述功能数据的所述值与所述一个或多个预定的接受参考值的所述比较向所述使用者提供可接受性指示包括向所述使用者提供医疗用途的装置可接受性的指示。
实施例6.根据实施例1至实施例5中的任一项所述的方法,还包括由所述超声医疗装置控制模块确定所述功能数据的所述值不在所述接受范围内,并且
其中基于所述功能数据的所述值与所述一个或多个预定的接受参考值的所述比较向所述使用者提供可接受性指示包括向所述使用者提供医疗用途的装置不可接受性的指示。
实施例7.根据实施例1至实施例6中的任一项所述的方法,还包括由所述超声医疗装置控制模块接收来自可编程存储器装置的所述一个或多个预定的接受参考值,所述可编程存储器装置设置在重新组装的超声医疗装置内。
实施例8.根据实施例7所述的方法,还包括在所述重新组装的超声医疗装置的初始制造期间,利用所述一个或多个预定的接受参考值对所述可编程存储器装置进行编程。
实施例9.根据实施例1至实施例8中的任一项所述的方法,其中,接收来自所述超声医疗装置的功能数据包括:接收来自所述超声医疗装置的参考管状致动构件的位移值的功能数据,所述管状致动构件被构造成能够致动所述重新组装的超声医疗装置的钳口。
实施例10.根据实施例9所述的方法,其中,接收来自所述超声医疗装置的参考管状致动构件的位移值的功能数据包括:接收来自霍尔效应传感器的数据,所述霍尔效应传感器被配置成能够测量所述管状致动构件的位移值。
实施例11.根据实施例1至实施例10中的任一项所述的方法,其中,接收来自所述超声医疗装置的功能数据包括:接收来自所述超声医疗装置的参考弹簧堆叠的位移值的功能数据,所述弹簧堆叠与被构造成能够致动所述重新组装的超声医疗装置的所述钳口的管状致动构件机械连通。
实施例12.根据实施例11所述的方法,其中,接收来自所述超声医疗装置的参考弹簧堆叠的位移值的功能数据包括:接收来自霍尔效应传感器的数据,所述霍尔效应传感器被配置成能够测量所述弹簧堆叠的位移值。
实施例13.根据实施例1至实施例12中的任一项所述的方法,还包括:
由所述超声医疗装置控制模块向声学地联接到超声波导的压电致动器提供电流,并且
其中接收来自所述超声医疗装置的功能数据包括:接收来自所述超声医疗装置的功能数据,所述功能数据参考与所述超声波导相关联的阻抗。
实施例14.根据实施例13所述的方法,其中,基于所述功能数据的所述值与所述一个或多个预定的接受参考值的比较向使用者提供可接受性指示包括:提供在所述重新组装的超声医疗装置中减振膜的存在的指示。
实施例15.根据实施例13至实施例14中的任一项所述的方法,其中,向声学地联接到超声波导的压电致动器提供电流包括向压电致动器提供电流,所述压电致动器被构造成能够在所述超声波导中感应出横向机械波。
实施例16.根据实施例13至实施例14中的任一项所述的方法,其中,向声学地联接到超声波导的压电致动器提供电流包括向压电致动器提供电流,所述压电致动器被构造成能够在所述超声波导中感应出非横向机械波。
实施例17.根据实施例16所述的方法,其中,向声学地联接到超声波导的压电致动器提供电流包括向声学地联接到所述超声波导的多个压电元件中的一个或多个提供电流,其中所述多个压电致动器中的所述一个或多个中的每个被构造成能够在所述超声波导中感应出非横向机械波。
实施例18.根据实施例13至实施例17中的任一项所述的方法,其中,基于所述功能数据的所述值与一个或多个预定的接受参考值的比较向使用者提供可接受性指示包括:提示所述使用者替换所述超声波导或替换声学地联接到所述超声波导的超声刀。
实施例19.根据实施例1至实施例18中的任一项所述的方法,还包括:
由所述超声医疗装置控制模块向声学地联接到超声波导的压电致动器提供电流,并且
由所述超声医疗装置控制模块接收来自所述超声医疗装置的功能数据,所述功能数据参考与声学地联接到所述超声波导的超声波导相关联的机械谐振频率。
实施例20.根据实施例19所述的方法,其中,向所述使用者提供可接受性指示包括提示所述使用者重新组装所述重新组装的超声医疗装置。
实施例21.根据实施例1至实施例20中的任一项所述的方法,其中,接收来自所述超声医疗装置的功能数据包括:接收来自所述超声医疗装置的参考垫的夹持力值的功能数据,所述垫与所述超声医疗装置的所述钳口机械连通,所述超声医疗装置的所述钳口抵靠所述重新组装的超声医疗装置的超声刀。
实施例22.根据实施例21所述的方法,其中,接收来自所述超声医疗装置的参考夹持力值的功能数据包括:接收来自压电力传感器的数据,所述压电力传感器机械联接到致动构件驱动组件的部件,所述致动构件驱动组件被构造成能够致动所述重新组装的超声医疗装置的所述钳口。
实施例23.根据实施例1至实施例22中的任一项所述的方法,其中,接收来自所述超声医疗装置的功能数据包括:接收来自所述超声医疗装置的参考远侧凸缘与近侧凸缘之间的距离的功能数据,所述远侧凸缘与延伸管机械连通,并且所述近侧凸缘与所述延伸管机械连通,其中所述延伸管被构造成能够致动所述重新组装的超声医疗装置的钳口。
实施例24.根据实施例1至实施例23中的任一项所述的方法,还包括:
由所述超声医疗装置控制模块提示所述使用者启动包括烧机过程的预运行过程;
由所述超声医疗装置控制模块在预定的时间段内激活所述预运行过程;以及
由所述超声医疗装置控制模块根据所述闭合数据确定所述端部执行器的所述钳口在所述预定的时间段处于闭合构型,
其中接收来自所述超声医疗装置的参考所述超声医疗装置的至少一个部件的功能状态的功能数据包括:接收在所述预定的时间段内参考超声刀的谐振频率的功能数据。
实施例25.一种可重复使用的超声医疗装置,包括:
柄部组件;
细长轴组件,所述细长轴组件机械联接到所述柄部组件,所述细长轴组件具有用电绝缘材料包覆的内部远侧部分,其中所述细长轴组件的近侧内部表面的至少一部分是导电的;
第一电触点,所述第一电触点电联接到所述细长轴组件的所述导电内部表面;
导电波导,所述导电波导设置在所述细长轴组件内;
第二电触点,所述第二电触点电联接到所述导电波导;
导电超声刀,所述导电超声刀声学地联接和电联接到所述波导,所述导电超声刀的远侧部分涂覆有电绝缘涂层;
发生器,所述发生器被构造成能够将功率递送到声学地联接到波导的超声换能器;以及
控制器模块,所述控制器模块被配置成能够控制所述发生器,其中控制器模块包括:
处理器;以及
存储器电路,所述存储器电路被配置成能够包含指令,当所述指令由所述处理器执行时,使得所述处理器:
在所述第一电触点与所述第二电触点之间施加电势;
测量在所述第一电触点与所述第二电触点之间流动的电流;
以及
当电压值在公差范围之外时,通知所述可重复使用的超声医疗装置的使用者。
实施例26.根据实施例25所述的超声医疗装置,其中,所述导电超声刀的所述远侧部分的所述电绝缘涂层具有近侧涂层边缘,所述近侧涂层边缘位于电绝缘材料的远侧边缘的远侧,所述电绝缘材料包覆在所述细长轴组件的所述内部远侧部分上。
实施例27.一种管理可重复使用的超声医疗装置的方法,所述方法包括:
由超声医疗装置控制模块接收来自由使用者重新组装的超声医疗装置的电连接;
由所述超声医疗装置控制模块在电联接到导电波导的第一触点与电联接到细长轴组件的导电内表面的第二触点之间施加电势,其中所述波导设置在所述细长轴组件内的内部空间中;
由所述超声医疗装置控制模块测量在所述第一触点与所述第二触点之间流动的电流;
由所述超声医疗装置控制模块将所述电流值与接受范围的一个或多个值进行比较;以及
由所述超声医疗装置控制模块基于所述电流的所述值与所述一个或多个预定的接受参考值的所述比较,向所述使用者提供可接受性指示。
实施例28.根据实施例27所述的方法,还包括由所述超声医疗装置控制模块确定所述电流的所述值在所述接受范围内,并且
其中基于所述电流的所述值与所述一个或多个预定的接受参考值的所述比较向所述使用者提供可接受性指示包括向所述使用者提供医疗用途的装置可接受性的指示。
实施例29.根据实施例27至实施例28中的任一项所述的方法,还包括由所述超声医疗装置控制模块确定所述电流的所述值不在所述接受范围内,并且
其中基于所述电流的所述值与所述一个或多个预定的接受参考值的所述比较向所述使用者提供可接受性指示包括向所述使用者提供医疗用途的装置不可接受性的指示。
实施例30.根据实施例29所述的方法,还包括由所述超声医疗装置控制模块提示所述使用者清洁或重新消毒所述重新组装的超声医疗装置的部件。
实施例31.一种可重复使用的超声医疗装置,包括:
柄部组件,所述柄部组件包括:
触发器组件;
触发器传感器,所述触发器传感器被配置成能够确定所述触发器组件的位置;
轭,所述轭机械联接到所述触发器组件;
致动构件驱动组件,所述致动构件驱动组件包括:
联接组件,所述联接组件包括:具有远侧凸缘和近侧凸缘的管套环、设置在所述远侧凸缘与所述近侧凸缘之间的弹簧堆叠以及机械联接到所述弹簧堆叠的力传感器,
其中所述联接组件被构造成能够在所述远侧凸缘与所述近侧凸缘之间接收所述轭;
细长轴组件,所述细长轴组件在近侧端部机械联接到所述柄部组件,所述细长轴组件包括:
外部护套;
管状致动构件,所述管状致动构件设置在所述外部护套内,其中所述管状致动构件的近侧部分机械联接到所述致动构件驱动组件;以及端部执行器组件,所述端部执行器组件在所述细长轴组件的远侧端部机械联接,其中所述端部执行器组件包括:
超声刀;以及
钳口组件,所述钳口组件被构造成能够可释放地接合所述超声刀,其中所述钳口组件机械联接到所述管状致动构件的远侧端部;以及
控制器模块,所述控制器模块被配置成能够接收来自所述触发器传感器的触发器位置数据和来自所述力传感器的力数据,
其中所述可重复使用的超声医疗装置的一个或多个部件被构造成能够由所述医疗装置的使用者替换。
实施例32.根据实施例31所述的可重复使用的超声医疗装置,其中,所述力传感器包括压电盘。
实施例33.根据实施例32所述的可重复使用的超声医疗装置,其中,所述控制器模块包括:
处理器;以及
第一存储器电路,所述第一存储器电路被配置成能够包含指令,当所述指令由所述处理器执行时,使得所述处理器:
确定设置在所述压电盘的第一侧上的第一触点与设置在所述压电盘的第二侧上的第二触点之间的电势值;
基于所述电势来计算力值;以及
当所述力值在公差范围之外时,通知所述可重复使用的超声医疗装置的使用者。
实施例34.根据实施例33所述的可重复使用的超声医疗装置,其中,所述柄部组件还包括可编程存储器电路,所述可编程存储器电路被配置成能够包含与公差范围对应的存储值,并且
其中所述控制器模块被配置成能够接收来自所述存储器电路的所述存储值。
实施例35.根据实施例33至实施例34中的任一项所述的超声医疗装置,其中,所述柄部组件还包括可编程存储器电路,所述可编程存储器电路被配置成能够包含电势/力标准化数据,并且
其中所述指令当由所述处理器执行时使得所述处理器基于所述电势计算力值包括指令,所述指令当由所述处理器执行时使得所述处理器基于所述电势和所述电势/力标准化数据来计算力值。
Claims (6)
1.一种可重复使用的超声医疗装置,包括:
柄部组件;
细长轴组件,所述细长轴组件机械联接到所述柄部组件,所述细长轴组件具有用电绝缘材料包覆的内部远侧部分,其中所述细长轴组件的近侧内部表面的至少一部分是导电的;
第一电触点,所述第一电触点电联接到所述细长轴组件的导电内部表面;
导电波导,所述导电波导设置在所述细长轴组件内;
第二电触点,所述第二电触点电联接到所述导电波导;
导电超声刀,所述导电超声刀声学地联接和电联接到所述波导,所述导电超声刀的远侧部分涂覆有电绝缘涂层;
发生器,所述发生器被构造成能够将功率递送到声学地联接到所述波导的超声换能器;以及
控制器模块,所述控制器模块被配置成能够控制所述发生器,其中所述控制器模块包括:
处理器;以及
存储器电路,所述存储器电路被配置成能够包含指令,当所述指令由所述处理器执行时,使得所述处理器:
在所述第一电触点与所述第二电触点之间施加电势;
测量在所述第一电触点与所述第二电触点之间流动的电流;以及
当电流的值在公差范围之外时,通知所述可重复使用的超声医疗装置的使用者。
2.根据权利要求1所述的超声医疗装置,其中,所述导电超声刀的所述远侧部分的所述电绝缘涂层具有近侧涂层边缘,所述近侧涂层边缘位于所述电绝缘材料的远侧边缘的远侧,所述电绝缘材料包覆在所述细长轴组件的所述内部远侧部分上。
3.一种管理可重复使用的超声医疗装置的方法,所述方法包括:
由超声医疗装置控制模块接收来自由使用者重新组装的超声医疗装置的电连接;
由所述超声医疗装置控制模块在电联接到导电波导的第一触点与电联接到细长轴组件的导电内表面的第二触点之间施加电势,其中所述波导设置在所述细长轴组件内的内部空间中;
由所述超声医疗装置控制模块测量在所述第一触点与所述第二触点之间流动的电流;
由所述超声医疗装置控制模块将所述电流的值与接受范围的一个或多个值进行比较;以及
由所述超声医疗装置控制模块基于所述电流的所述值与所述一个或多个预定的接受参考值的所述比较,向所述使用者提供可接受性指示。
4.根据权利要求3所述的方法,还包括由所述超声医疗装置控制模块确定所述电流的所述值在所述接受范围内,并且
其中基于所述电流的所述值与所述一个或多个预定的接受参考值的所述比较向所述使用者提供可接受性指示包括向所述使用者提供医疗用途的装置可接受性的指示。
5.根据权利要求3所述的方法,还包括由所述超声医疗装置控制模块确定所述电流的所述值不在所述接受范围内,并且
其中基于所述电流的所述值与所述一个或多个预定的接受参考值的所述比较向所述使用者提供可接受性指示包括向所述使用者提供医疗用途的装置不可接受性的指示。
6.根据权利要求5所述的方法,还包括由所述超声医疗装置控制模块提示所述使用者清洁或重新消毒所述重新组装的超声医疗装置的部件。
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