CN111658045A - 手术装置中的应变计稳定化 - Google Patents
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Abstract
本发明涉及手术装置中的应变计稳定化，并提供了适配器组合件且其包括具有近端部分和远端部分并限定纵向轴线的管状壳体；负荷感测组合件，其布置在管状壳体内，在近侧表面和远侧表面之间接触，所述近侧和远侧表面垂直于纵向轴线，所述负荷感测组合件配置成测量施加在管状壳体上的负荷，所述负荷感测组合件包括传感器主体；和万向架，所述万向架设置在传感器主体表面与所述近侧表面或所述远侧表面中的至少一个之间，所述万向支架配置成将传感器主体与施加在垂直于纵向轴线的平面上的负荷隔离。
Description
相关申请的交叉引用
本申请要求2019年3月8日提交的美国临时专利申请系列号62/815,563的权益和优先权并且要求2019年8月2日提交的美国临时专利申请系列号62/881,992的权益和优先权，将它们的全部公开内容通过引用并入本文。
技术领域
本公开涉及手术装置。更具体地说，本公开涉及用于执行手术程序的手持式机电手术系统，其具有带有负荷感测装置的可再使用的部件。
背景技术
一种类型的手术装置是圆形夹持、切割和钉合装置。这类装置可以在手术程序中用于重新附接先前横断的直肠部分或相似程序。常规的圆形夹持、切割和钉合装置包含手枪或线性握把式结构，其具有从其延伸的细长轴和支撑在细长轴的远侧端上的钉仓。在此情况下，医生可以将圆形钉合装置的装载单元部分插入到患者的直肠中，且沿着患者的结肠道向上朝向横断的直肠部分操纵装置。装载单元包含具有多个钉的仓组合件。沿着横断的结肠的近侧部分，可以将砧座组合件缩拢系于其中。替代地，如果需要，砧座部分可以通过邻近横断的结肠的切口插入结肠中。砧座和仓组合件朝向彼此接近，并且钉从仓组合件朝向砧座组合件弹射从而在组织中形成钉以实现端对端吻合，且起动环形刀以对所夹持组织部分的一部分进行取芯。在已经实现端对端吻合之后，将圆形钉合装置从手术部位移除。
许多手术装置制造商还已开发了用于操作和/或操纵末端执行器的专有供电式驱动系统。供电式驱动系统可以包含可重新使用的供电式手柄组合件和可移除地连接到供电式手柄组合件的一次性末端执行器。
供与现有供电式手术装置和/或手柄组合件一起使用的许多现有末端执行器是由线性驱动力驱动的。举例来说，用于执行内胃肠道吻合程序、端对端吻合程序和横向吻合程序的末端执行器是由线性驱动力致动的。由此，这些末端执行器与使用旋转运动的手术装置和/或手柄组合件不兼容。
为了使线性驱动的末端执行器与使用旋转运动来递送电力的供电式手术装置兼容，需要适配器以将线性驱动的末端执行器与供电式旋转驱动的手术装置互连。这些适配器也可以重复使用，并因此需要能够承受多个灭菌循环。随着这些适配器变得越来越复杂并且包括各种电子部件，需要设置在适配器内的电子部件能够承受多个高压灭菌循环。
发明内容
供电式手术装置可包含用于在其操作期间提供反馈的各种传感器。但是，在手术室无菌环境中使用的电子设备和传感器的一种局限性在于它们需要设计成承受多次清洁和高压灭菌循环。为了收集由供电式手术装置施加的机械力上的信息，诸如负荷传感器的负荷感测装置被布置在供电式手术装置的一个或多个机械部件和/或联接到其上的适配器上。
利用应变计的供电式手术装置使用户能够获得力感知反馈，这可以带来许多优势。力监测的益处包括砧座检测、钉合检测、切割、控制组织压缩以免在最大化钉合形成一致性时出现的组织损伤、对冲程进行过度负荷调整以优化钉合形成、组织厚度识别等等。由于负荷感测装置的敏感性，任何意外的作用在应变计上的力或应变都会对装置的精度产生负面影响。
本公开提供了一种适配器组合件，其具有负荷感测装置和在该负荷感测装置的约束条件下布置的万向架。负荷感测装置布置在两个平行的相对表面之间，并且测量由于适配器组合件内的各种致动组合件的致动而施加到其上的应变。负荷感测装置在两个相对的平行表面之间的位置在套管针组合件的方向上引入了离轴变化，这改变了负荷感测装置上的负荷，从而改变了测量的准确性。万向架的放置允许负荷感测装置仅以单轴应变即沿纵向方向负荷，而没有额外的力矩或离轴负荷，即沿垂直于纵轴线的平面负荷。万向架是双摇动机构，其允许在负荷感测装置上的负荷点旋转，从而套管针组合件的方向变化不会影响负荷感测装置的负荷状况。
负荷感测装置还耦合到信号处理和调节电路，该信号处理和调节电路与负荷感测装置分开包装。这些电路处理负荷感测设备的电阻变化，并确定施加到其上的负荷。特别地，信号处理电路的组件通常布置在印刷电路板(“PCB”)上，印刷电路板容纳有与供电式手术装置的其他电子和电气组件。这些电路组件远离负荷感测装置的远程放置是由于它们的尺寸和形状，其阻止PCB紧靠负荷感测装置。因此，这些电路通过有线连接件连接到负荷感测装置，所述有线连接件包括较长的引线(例如，超过10厘米的柔性印刷电路迹线)，用于将模拟信号从负荷感测装置传输到信号处理电路。较长的有线连接导致信号丢失，还会增加由于暴露于消毒和灭菌循环中而导致故障的机会。消毒溶液造成的恶劣环境以及高压灭菌过程中残留的水分会破坏柔性电路中的组件和涂层，从而导致信号衰减。此外，在使用盐水冲洗的手术装置中，盐水进一步破坏这些电路的机械完整性，从而导致信号衰减。
另外，负荷感测装置与信号处理电路之间的间隔也影响从负荷感测装置发送的模拟感测信号的保真度。模拟电压信号是低压信号，因此由于PCB中的水分进入、焊料连接和/或迹线、包括焊剂通量和高压灭菌器矿物质沉积在内的小污染、以及由于导体行进距离长而造成的射频干扰，更容易受到负荷感测装置测得的负荷的干扰。远程放置信号处理电路也导致较低的位分辨率。此外，由于容纳负荷感测装置的传感器主体的不一致(例如，在传感器的制造和组装期间)，与负荷感测装置一起使用的常规信号处理电路不具有补偿负荷感测装置中的零平衡波动的能力。如本文所使用的，术语“零平衡”表示来自负荷感测装置的对应于负荷感测装置被卸载的状况的基线信号。
本公开提供了一种组合式负荷感测组合件，其具有一个或多个负荷感测装置以及布置在传感器的气密性壳体内的信号处理电路。这消除了沿长引线传输模拟负荷感测信号的问题，并保护了负荷感测装置和信号处理电路免受暴露于包括灭菌循环(例如高压灭菌)在内的因素的影响。另外，信号处理电路是可编程的，以通过调整传感器信号的增益和偏移值来优化传感器信号。
利用应变计技术的常规负荷感测装置通常遭受负荷感测装置的可调节性或调整性的缺乏。特别地，负荷感测装置中的变化、传感器主体中的公差、负荷感测装置的放置以及其他因素导致零平衡变化，这导致整个负荷感测装置中的零平衡值可变。遗憾的是，在传统的负荷感测装置中，不能为每个单独的负荷感测装置调节零平衡。本公开提供了一种信号处理电路，其可以被编程为在制造和/或组装负荷传感器之后调节零平衡。
本公开提供了多个实施例，每个实施例包括多个方面。实施例的各个方面在所公开的实施例之间是可互换的。根据本公开的一个实施例，适配器组合件包括：管状壳体，该管状壳体具有近端部分和远端部分并且限定纵向轴线。适配器组合件还包括负荷感测组合件，该负荷感测组合件设置在管状壳体内，并在近侧表面和远侧表面之间接触，该近侧和远侧表面垂直于纵向轴线，该负荷感测组合件配置成测量施加在管状壳体上的负荷，所述负荷感测组合件包括传感器主体。适配器组合件包括万向架，该万向架设置在传感器主体表面与近侧表面或远侧表面中的至少一个之间，该万向架配置成将传感器主体与施加在垂直于纵向轴线的平面中的负荷隔离。
根据本公开的另一个实施例，一种手术装置包括：手柄组合件，其包括控制器；以及适配器组合件，其具有：管状壳体，该管状壳体具有近端部分和远端部分并限定纵向轴线；负荷感测组合件，该负荷感测组合件设置在管状壳体内，并在近侧表面和远侧表面之间接触，该近侧和远侧表面垂直于纵向轴线，该负荷感测组合件配置成测量施加在管状壳体上的负荷。负荷感测组合件包括传感器主体；和万向架，该万向架设置在传感器主体表面与近侧表面或远侧表面中的至少一个之间，该万向架配置成将传感器主体与施加在垂直于纵向轴线的平面中的负荷隔离；和手术末端执行器，其配置成联接到适配器组合件的所述远端部分。
根据以上实施例中任一个的一个方面，负荷感测组合件还包括：负荷传感器电路，其布置在传感器主体内。适配器组合件还可以包括信号处理电路，该信号处理电路布置在传感器主体内并且电耦合至负荷传感器电路。
根据以上实施例中任一个的另一方面，万向架具有管状形状，该管状形状具有宽度、厚度和半径。万向架的近侧表面和万向架的远侧表面包括一对峰。万向架的近侧表面和远侧表面中的每一个限定具有由πr限定的波长的波形，其中r是具有等于管状形状的厚度的振幅的管状形状的半径。万向架还包括近侧表面和远侧表面，万向架的近侧表面和万向架的远侧表面中的每一个均具有起伏形状。传感器主体包括管状部分，并且万向架设置在管状部分上。
根据本公开的一个实施例，适配器组合件包括：管状壳体，该管状壳体具有近端部分和远端部分并且限定纵向轴线。适配器组合件还包括负荷感测组合件，该负荷感测组合件设置在管状壳体内，并在近侧表面和远侧表面之间接触。近侧表面和远侧表面中的每一个均垂直于纵向轴线。负荷感测组合件，其配置成测量施加在所述管状壳体上的负荷。负荷感测组合件还包括传感器主体，其中近侧表面或远侧表面中的至少一个包括第一表面特征，并且传感器主体包括与第一表面特征接合的第二表面特征。
根据以上实施例的一个方面，第一表面特征是凸表面特征，而第二表面特征是凹表面特征。第一表面特征可以是具有第一弯曲横截面的脊突。第二表面特征可以是具有第二弯曲横截面的凹槽。第一弯曲横截面和第二弯曲横截面具有相同的半径。传感器主体被配置为绕着横向于由传感器主体限定的纵向轴线的枢转轴线枢转。枢转轴线由脊突限定并且穿过第一弯曲横截面和第二弯曲横截面的每个中心。
根据以上实施例的另一方面，第一表面特征是凹表面特征，并且第二表面特征是凸表面特征。第一表面特征是具有第一弯曲横截面的凹槽。第二表面特征是具有第二弯曲横截面的脊突。第一弯曲横截面和第二弯曲横截面具有相同的半径。传感器主体被配置为绕着横向于由传感器主体限定的纵向轴线的枢转轴线枢转。枢转轴线由脊突限定并且穿过第一弯曲横截面和第二弯曲横截面的每个中心。
附图说明
在本文中参考附图描述本公开的实施例，其中：
图1为根据本公开的实施例的手持式手术装置、适配器组合件、具有再装载件的末端执行器和砧座组合件的透视图；
图2为说明根据本公开的实施例的图1的适配器组合件和手柄组合件的连接的透视图；
图3为根据本公开的实施例的手柄组合件的内部部件的透视图；
图4是根据本公开的实施例的无再装载件的图1的适配器组合件的透视图；
图5是根据本公开的实施例的图1的再装载件的侧截面视图；
图6A是根据本公开的实施例的适配器组合件的远端部分的透视图；
图6B是根据本公开的实施例的适配器组合件的远端部分的截面视图；
图7是根据本公开的实施例的图1的适配器组合件的电气组合件的透视图；
图8是根据本公开的实施例的图7的电气组合件的远侧部分的透视图；
图9是根据本公开的实施例的图7的电气组合件的负荷感测组合件的透视俯视图；
图10是图9的负荷感测组合件的仰视透视图；
图11是图9的负荷感测组合件的截面侧视图；
图12是没有盖的图8的负荷感测组合件的透视俯视图；
图13是图8的负荷感测组合件的透视俯视图，其没有负荷传感器电路和信号处理电路；
图14是根据本公开的实施例的图9的负荷感测组合件的盖的透视俯视图；
图15是图14的盖的仰视透视图；
图16是根据本公开的设置在图8的负荷感测组合件的一部分上方的万向架的侧视图。
图17是根据本公开的实施例的负荷感测组合件和支撑块的俯视图；
图18是图17的负荷感测组合件和支撑块的透视图；
图19是根据本公开的实施例的负荷感测组合件和支撑块的俯视图；
图20是图19的负荷感测组合件和支撑块的透视图；
图21是根据本公开的实施例的负荷感测组合件和支撑块的俯视图；
图22是图21的负荷感测组合件和支撑块的透视图；
图23是根据本公开的实施例的负荷感测组合件、适形的万向架和支撑块的透视图；
图24是根据本公开的实施例的图9的负荷感测组合件的引脚连接器的剖视图；和
图25是根据本公开的实施例的负荷传感器电路和信号处理电路的俯视示意图；和
图26是根据本公开的实施例的图25的信号处理电路的电气示意图。
具体实施方式
现在参考图式详细描述本公开的实施例，其中在若干视图中的每一个中，相同附图标号指定相同或对应元件。实施例可以以与本文公开的装置和/或方法的功能一致的任何方式组合。如本文中所使用，术语“临床医生”是指医生、护士或任何其它医护人员且可以包含辅助人员。贯穿本说明书，术语“近侧”将是指更接近临床医生的装置的部分或其部件，并且术语“远侧”将是指更远离临床医生的装置的部分或其部件。术语“基本上等于”表示两个值彼此为±5％。此外，在附图中和在以下描述中，为描述方便起见简单地使用术语，如前部、后部、上部、下部、顶部、底部和类似的方向术语，并且不旨在限制本公开。在以下描述中，未详细描述众所周知的功能或构造，以免以不必要的细节使本公开模糊不清。
本公开涉及具有电子传感器的供电式手术装置，所述电子传感器用于监测施加在供电式手术装置的组件上的机械应变和力。更具体地说，本公开涉及负荷测量传感器，所述负荷测量传感器包含负荷感测装置以及模拟和数字电路，所述负荷感测装置和模拟和数字电路是气密密封式的，使得负荷传感器配置成抵抗恶劣环境。在使用期间供电式手术装置的电连接受到损坏的情况下，由本公开的传感器输出的测量信号保持不变。此外，传感器是可编程的，以允许调整增益和偏移值，以便优化测量信号。
参考图1，供电式手术装置10包含手柄组合件20，所述手柄组合件20被配置成用于与适配器组合件30选择性连接，所述适配器组合件30又被配置成用于与如环形再装载件40的末端执行器选择性连接。尽管通常被称为供电式手术装置，但预期，手术装置10可以是手动致动的且可包含各种配置。
手柄组合件20包含手柄壳体22，其具有下部壳体部分24、从下部壳体部分24延伸和/或支撑在下部壳体部分24的一部分上的中间壳体部分26，和从中间壳体部分26延伸和/或支撑在中间壳体部分26的一部分上的上部壳体部分28。如图2所示，上部壳体部分28的远侧部分限定鼻部或连接部分28a，其被配置成接纳适配器组合件30的近侧端部分30b。
参考图3，手柄组合件20包含联接到电池37的一个或多个马达36。手柄组合件20还包含用于操作手柄组合件20的电动机36和其它电子组件的主控制器38、适配器组合件30和再装载件40。电机36联接到对应驱动轴39(图2)，所述对应驱动轴配置成将插口33接合在近侧端部分30b上，使得在插口33上施加驱动轴39的旋转。致动组合件52(图6B)联接到相应的插口33。致动组合件52被配置成将插口33的旋转运动转换成线性运动并连同砧座组合件58一起致动再装载件40(图1)。
参考图4，适配器组合件30包含管状壳体30a，其在近侧端部分30b与相反的远端部分30c之间延伸，所述近侧端部分30b被配置成用于可操作地连接到手柄组合件20的连接部分28a，所述相反的远端部分30c被配置成用于可操作地连接到再装载件40。以此方式，适配器组合件30被配置成将由手柄组合件20提供的旋转运动转换成轴向平移，其可用于推进/缩回可滑动地安置于适配器组合件30的远端部分30c内的套管针构件50(图5)，以起动再装载件40的钉。
参考图2，连接部分28a包含具有多个电触点31的电插座29，所述多个电触点与手柄组合件20的电子组件(例如，主控制器38)和电组件(例如，电池37)电连通。适配器组合件30包含配置成接合电插座29的对应电连接器32。电连接器32还包含多个电触点34，其接合且电连接到其对应电触点31。
参看图4，套管针构件50可滑动地安置于适配器组合件30的管状壳体30a内且延伸通过其远端部分30c。以此方式，套管针构件50被配置成用于轴向平移，这又致使再装载件40的砧座组合件58(图1)的对应轴向平移，以起动安置于其中的钉(未示出)。套管针构件50包含近侧端，其联接到适配器组合件30的管状壳体30a。套管针构件50的远端部分被配置成选择性地接合再装载件40的砧座组合件58(图4)。以此方式，当砧座组合件58连接到套管针构件50时，如下文中将详细描述，套管针构件50在第一方向上的轴向平移导致砧座组合件58相对于再装载件40的打开，且套管针构件50在第二相反方向上的轴向平移导致砧座组合件58相对于再装载件40的关闭。
如图1和5所示，再装载件40被配置成用于可操作地连接到适配器组合件30且被配置成起动和形成手术钉的环形阵列，并切断组织环。再装载件40包含具有近侧端部分42a和远端部分42b的壳体42以及固定地紧固到壳体42的远端部分42b的钉仓44。壳体42的近侧端部分42a被配置成用于选择性连接到适配器组合件30的远端部分30c且包含用于确保再装载件40相对于适配器组合件30径向对齐或对准的装置。
参考图5，再装载件40的壳体42包含外圆柱形部分42c和内圆柱形部分42d。再装载件40的外圆柱形部分42c和内圆柱形部分42d是同轴的且限定凹槽46。再装载件40的凹槽46包含从其内表面凸出的多个纵向延伸的脊状部或花键48，所述内表面被配置成在钉合程序期间将砧座组合件58相对于再装载件40径向对齐。
现参看图6A-8，适配器组合件30包含电气组合件60，其安置在适配器组合件内且配置成用于与手柄组合件20和再装载件40电连接且在手柄组合件20与再装载件40之间电连接。电气组合件60提供通过电插座29与手柄组合件20的主控制器38的连通(例如，识别数据、寿命周期数据、系统数据、负荷感测信号)。
电气组合件60包含电连接器32、具有带状电缆的近侧线束组合件62、具有带状电缆的远侧线束组合件64、负荷感测组合件66和远侧电连接器67。电气组合件60还包含远侧电连接器67，其配置成选择性地以机械和电气方式连接到再装载件40的芯片组合件(未示出)。
电气组合件60的电连接器32支撑在适配器组合件30的近侧端部分30b内。电连接器32包含电触点34，其能够实现电连接到手柄组合件20。近侧线束组合件62电连接到布置在印刷电路板35上的电连接器32。
负荷感测组合件66经由近侧和远侧线束组合件62、64电连接到电连接器32。负荷感测组合件还经由传感器弯曲电缆电连接到远侧线束组合件64。如图6A和6B所示，联接到套管针构件50的致动组合件52延伸通过负荷感测组合件66。负荷感测组合件66提供在夹持、钉合、切割和其它机械致动期间当联接到砧座组合件58时套管针构件50的移动期间对适配器组合件30施加的应变测量。
对于包含适配器组合件和再装载件的示例性供电式手术钉合器的详细描述，可以参考Contini等人的2016年4月12日提交的标题为“手持式机电手术系统(HandheldElectromechanical Surgical System)”的美国专利申请公开第2016/0310134号，其以引用方式并入上文中。
参考图9-13，负荷感测组合件66包括具有平台70的传感器主体68和从平台70延伸距离“d”的管状部分72。传感器主体68还限定了穿过平台70的内腔73和管状部分72，从而将平台70分成第一部分74和第二部分76。内腔73允许致动组合件52从中穿过。传感器主体68可以由诸如不锈钢的任何合适的材料形成，其允许传感器主体68在受应力时发生弹性变形。在实施例中，传感器主体68可以由不锈钢制成，例如热处理到H-900标准的17-4不锈钢。
管状部分72可具有任何合适的形状，例如圆柱形、刻面或其组合，如图10所示。更具体地，管状部分72包括通过圆角角部72b互连的多个侧壁72a。管状部分72还包括底部接触表面72c。平台70还包括顶(例如远侧)表面78和底(例如近侧)表面80(图10)以及限定在平台70的第一部分74内的第一狭槽82和限定穿过平台70的第二部分76的第二狭槽84。狭槽82和84与传感器主体68的设计结合工作，以在加载时提供均匀的弯曲。均匀的负荷和所产生的应变输出导致负荷感测组合件66的负荷传感器电路86(图11和12)以在平台70的第一部分74处提供线性应变输出，该线性应变输出由负荷传感器电路86测量，该负荷传感器电路固定在第一部分74上并被盖88覆盖，如图11所示。
参考图6A和6B，负荷感测组合件66安置在支撑块54与连接器套筒56之间。特别地，底部接触表面72c上的传感器主体68的管状部分72搁置在支撑块54上，并且平台70的顶表面78邻接连接器套筒56的近端。在手术装置10的操作(即夹持、钉合和切割)期间，传感器主体68与施加到支撑块54和连接器套筒56的力成比例地弹性变形(类似于支撑梁)。特别地，传感器主体68的挠曲向负荷传感器电路86(图11和图12)施加力，其发生变形，导致其电阻增加，这反映在其测量信号中。测量信号的基线的变化指示施加在支撑块54和连接器套筒56上的力，这些力通常描述了在夹持、钉合和切割期间遇到的力。
参考图16，适配器组合件30还包括布置在管状部分72上方的万向架81。万向架81可以由任何高抗拉强度的材料形成，例如不锈钢和其他金属。万向架81具有管状形状，其具有宽度“d”、厚度“t”和半径“r”。宽度“d”基本上等于距离“d”。万向架81包括顶(例如远侧)表面83a和底(例如近侧)表面83b。顶表面83a和底表面83b中的每一个具有分别具有一个或多个波形85a和85b的波状形状。波形85a和85b可以具有基于万向架81的半径“r”的波长，即“πr”，和基本上等于万向架81的厚度“t”的振幅。波形85a和85b中的每一个分别包括多个峰87a和87b。
万向架81设置在平台70的底表面80与支撑块54之间。更具体地，万向架81的顶表面83a与平台70的底表面80接触，并且万向架81的底表面83b与支撑块54的远侧表面接触。由于顶表面83a和底表面83b中的每一个分别包括峰87a和87b，因此峰87a和87b与它们各自的表面即底表面80和支撑块54接触。
当负荷感测组合件66被压缩在支撑块54和连接器套筒56之间时，支撑块54在万向架81上施加压力。除了纵向压力外，万向架81还消除了支撑块54的横向运动。这是因为由于顶表面83a和底表面83b具有起伏形状造成的万向架81的双重摇摆构造。特别地，万向架81绕顶表面83a和底表面83b与传感器主体68的底表面80和支撑块54之间的接触点即峰87a和87b旋转。在顶表面83a和底表面83b中的每个上包括两个峰87a和87b，通过防止离轴负荷，即在垂直于由传感器主体68限定的纵向轴线X-X的平面中施加的应力，隔离传感器主体68，由负荷传感器电路86测量所述应力。这允许负荷传感器电路86仅测量在纵向方向上施加的应力，这提供了精确的测量。
在实施例中，万向架81可以布置在传感器主体68的远侧。更具体地，万向架81可以设置在连接器套筒56和传感器主体68的顶表面78之间。因此，管状部分72可以设置在顶表面78上而不是底表面80上。在远侧构造中，万向架81可以围绕管状部分72布置并且以与上述近侧构造相同的方式起作用。
在进一步的实施例中，传感器主体68可以设置在两个万向架81之间，即，在支撑块54和/或连接器套筒56之间。在另外的实施例中，管状部分72可以是任何合适的固定结构，诸如柱、凹陷等，其将允许将万向架81固定到传感器主体68。
在另外的实施例中，万向架81可以具有平坦的顶表面83a和底表面83b，并且与万向架接触的表面，例如平台70的底表面80和支撑块54的远侧表面，可以具有起伏形状，其具有一个或多个波形85a和85b，如上所述。
参考图17和18，适配器组合件30可以包括支撑块154和传感器主体168。可以使用支撑块154和传感器主体168来代替支撑块54以及传感器主体68和万向架81，以隔离传感器组合件66。支撑块154包括凸表面特征，即具有弯曲横截面的脊突156。传感器主体168包括对应的凹入表面特征，即弯曲凹槽170。弯曲凹槽170形成在管状部分72的近侧表面上。弯曲凹槽170和脊突156沿着横向于纵向轴线X-X的枢转轴线Y-Y布置。弯曲凹槽170和脊突156具有基本相同的半径r2，使得脊突156装配在弯曲凹槽170内，从而允许传感器主体168绕枢转轴线Y-Y相对于支撑块154枢转。枢转轴线Y-Y穿过限定脊突156和弯曲凹槽170的弧的中心。脊突156和弯曲凹槽170的枢转配置通过防止离轴负荷，即在垂直于位于轴线Y-Y上的纵向轴线X-X的平面上施加的应力，使传感器主体168隔离，从所述应力由负荷传感器电路86测量。这允许负荷传感器电路86仅测量在纵向方向上施加的应力，这提供了施加在适配器组合件30上的应变的精确测量。
参考图19和20，适配器组合件30可以包括支撑块254和传感器主体268。可以使用支撑块254和传感器主体268代替支撑块54以及传感器主体68和万向架81以隔离传感器组合件66。图19和20的实施例类似于图17和18的实施例，其中凹表面和凸表面的位置相反。特别地，支撑块254包括凹表面特征，即具有弯曲横截面的弯曲凹槽270。传感器主体268包括对应的凸表面特征，即脊突256。脊突256和弯曲凹槽270沿着横向于纵向轴线X-X的枢转轴线Y-Y设置。脊突256和弯曲凹槽270具有基本相同的半径r2，使得弯曲凹槽270装配在脊突256内，从而允许传感器主体268绕着枢转轴线Y-Y相对于支撑块254枢转。弯曲凹槽270和脊突256的枢转配置通过防止离轴负荷，即在垂直于位于轴线Y-Y上的纵向轴线X-X的平面上施加的应力，使传感器主体268隔离，从所述应力由负荷传感器电路86测量。这允许负荷传感器电路86仅测量在纵向方向上施加的应力，这提供了施加在适配器组合件30上的应变的精确测量。
参考图21和22，适配器组合件30可以包括支撑块354和传感器主体368。可以使用支撑块354和传感器主体368代替支撑块54以及传感器主体68和万向架81以隔离传感器组合件66。图21和22的实施例类似于图19和20的实施例。特别地，支撑块354也包括凹表面特征，即具有弯曲横截面的弯曲凹槽370。另外，万向架181设置在支撑块354与传感器主体368之间。万向架181包括对应的凸表面特征，即设置在第一接触表面181a上的脊突356。脊突356和弯曲凹槽370沿着横向于纵向轴线X-X的枢转轴线Y-Y设置。脊突356和弯曲凹槽370具有基本相同的半径r2，使得弯曲凹槽370装配在脊突356内，从而允许万向架181绕着枢转轴线Y-Y相对于支撑块354枢转。
此外，万向架181还包括一个或多个凹表面特征，即具有弯曲横截面的弯曲凹槽183。弯曲凹槽183设置在与第一接触表面181a相对的第二接触表面181b上。传感器主体368包括对应的凸表面特征，即脊突456。脊突456和弯曲凹槽183沿着横向于纵向轴线X-X和枢转轴线Y-Y的枢转轴线Z-Z设置。脊突456和弯曲凹槽183具有基本相同的半径r3，使得弯曲凹槽183装配在脊突456内，从而允许万向架181绕着枢转轴线Z-Z相对于传感器主体368枢转。万向架181相对于支撑块354和传感器主体368的双重枢转构造通过防止离轴负荷，即在垂直于在在Y-Y和Z-Z轴线上的纵向轴线X-X的平面上施加的应力，提供了传感器主体268的隔离，由负荷传感器电路86测量该应力。这允许负荷传感器电路86仅测量在纵向方向上施加的应力，这提供了施加在适配器组合件30上的应变的精确测量。
参考图23，示出了万向架281的另一实施例。参考图23，适配器组合件30还包括布置在管状部分72上方的万向架281。万向架281可以由任何弹性的适形的材料形成，例如硅橡胶。合适的硅橡胶包括室温硫化(RTV)硅橡胶；高温硫化(HTV)硅橡胶和低温硫化(LTV)硅橡胶。这些橡胶是已知的并且容易商购，例如均来自Dow Corning的
735黑RTV和
732RTV；和均来自通用电气的106RTV硅橡胶和90RTV硅橡胶。其他合适的硅氧烷材料包括硅烷，硅氧烷(例如聚二甲基硅氧烷)，例如氟硅氧烷，二甲基硅氧烷，液态硅橡胶，例如乙烯基交联的可热固化橡胶或硅烷醇室温交联的材料等。万向架81包括顶(例如远侧)表面283a和底(例如近侧)表面283b。
万向架281设置在传感器主体68和支撑块54之间。更具体地，万向架281的顶表面283a与传感器主体68的管状部分72接触，并且万向架281的底表面283b与支撑块54的远侧表面接触。当负荷感测组合件66被压缩在支撑块54和连接器套筒56之间时，支撑块54在万向架281上施加压力。除了纵向压力之外，由于万向架281的压缩，支撑块54的横向运动被抵消。
关于图17-23的实施例，传感器主体68、万向架181和281、凹表面和凸表面特征的方向可以颠倒，可以布置在传感器主体68的远侧，使得界面布置在传感器主体68的远侧。更具体地，上述凹面或凸面特征可以形成在连接器套筒56和传感器主体68的顶表面78上而不是管状部分72上。
参考图11、12和25，负荷传感器电路86耦合到信号处理电路90，该信号处理电路包括具有接触部分94和信号处理电路部分96的柔性电路板92。接触部分94经由柔性带98与信号处理电路部分96互连，并且包括多个第一直通接触件100。信号处理电路90包括模拟和数字电路组件(例如，控制器130)，其被配置为对来自负荷传感器电路86的信号进行信号处理并将测量信号输出至手柄组合件20。
柔性电路板92可以是任何合适的介电多层柔性材料，例如可从特拉华州威尔明顿的杜邦公司获得的
材料、液晶聚合物材料等。在实施例中，柔性电路板92可以包括附加的介电层，其使柔性电路板92变硬，使得沿着柔性电路板92定位的组件的焊料连接不会由于热膨胀和/或负荷感测组合件66的机械运动而经受不期望的运动。在实施例中，柔性电路板92可以以平坦状态制造(图25)，并且在焊接到传感器主体68(图11)期间形成。在另外的实施例中，可以使用带有或不带有热量的固定装置来预弯曲柔性电路板92，以形成图11中所示的期望形状。
接触部分94被配置为联接至负荷传感器电路86，该负荷传感器电路包括通过多个迹线或其他导体互连的一个或多个负荷感测装置102。在实施例中，负荷感测装置102可以是应变计、压力传感器(例如，压力感测膜)或被配置为测量机械力和/或应变并响应于此输出电信号的任何其他合适的换能器装置。当负荷感测电路86结合到传感器主体68上使得在负荷感测组合件66弹性变形时负荷感测装置102位于线性应变输出的各个区域中时实现了信号输出。
负荷传感器电路86可以是单个电路板，例如柔性电路板，其中负荷感测装置102设置在其上并且经由内部迹线电互连。负荷感测装置102还经由迹线电联接到多个第二直通接触件101。在实施例中，负荷感测装置102可以单独地而不是通过负荷感测器电路86附接到平台70的第一部分74，然后布线在一起以提供电耦合。
可以以各种配置将多个负荷感测装置102布置在负荷传感器电路86上以实现温度补偿或其他电阻器网络，例如惠斯通电桥，其中两个负荷感测装置102被布置为响应于负荷感测组合件66的张力而移动，并且两个负荷感测装置102被布置为响应于负荷感测组合件66的压缩而移动。如图25所示，四个负荷感测装置102的配置可以提供最大信号输出和温度补偿，并且被称为全桥电路。
参考图13，第一部分74还包括具有测量表面106的凹穴104，用于连接负荷传感器电路86和信号处理电路90的接触部分94。在实施例中，负荷传感器电路86可以结合到测量表面106，使得信号处理电路90响应于传感器主体68输出测量信号。凹穴104还包括狭槽108，该狭槽具有穿过其中的多个引脚110。
如图11所示，狭槽108穿过凹穴104到达底表面80。引脚110通过多个第二直通接触件101(图25)电连接至信号处理电路90。特别地，当负荷传感器电路86结合到凹穴104时，第二直通接触件101被插入到引脚110上方。此后，接触部分94的第一直通接触件100也插入到引脚110上。第一和第二直通接触件100和101被对准，使得在将引脚110焊接到其上之后，信号处理电路90和负荷传感器电路86被电联接至引脚110并且彼此电联接。在实施例中，可以存在四个引脚110，其中引脚110中的两个充当通信线，其余两个引脚110提供用于向负荷传感器电路86和信号处理电路90通电的电力。焊接之后，柔性电路板92可以布置成装配在盖88内。
在实施例中，柔性电路板92可以如图11和12所示折叠和/或弯曲。在另外的实施例中，支撑结构112可以设置在凹穴104内。支撑结构112包括柔性电路板92附接到其上的一个或多个表面114。支撑结构112可以具有任何合适的形状，以使得柔性电路板92符合支撑结构112的形状。柔性电路板92可以以任何合适的方式固定到支撑结构112，例如，粘结、紧固件等。
在另外的实施例中，包裹物116可以设置在柔性电路板92上，以使信号处理电路部分96的电子组件绝缘，并且如果柔性电路板92接触盖88的内表面则防止短路。包裹物116可以是聚酰亚胺胶带或离聚物树脂胶带，例如分别来自特拉华州威尔明顿的杜邦公司的
和
收缩包装，聚异戊二烯膜，低硬度灌封化合物，聚对二甲苯涂层，以及其他适用于绝缘电子电路的介电材料和应用。
参考图10-13，引脚110固定在头部118内，头部118在底表面80处气密地密封凹穴104。如图24所示，每个引脚110被封装在玻璃套筒120中，然后每个玻璃套筒被嵌入外围壳体122中。一旦头部118在平台的底表面80处结合到狭槽108，则该构造将盖88和凹穴104的内部与外部密封。头部118可以结合(例如，焊接)到底表面80。
可以通过将引脚110穿过其各自的玻璃套筒120来形成气密密封，之后，将引脚110及其玻璃套筒120插入到头部118的外围壳体122的相应孔中。引脚110、玻璃套筒120和外围壳体122的整个组合件被加热。在加热时，可由任何合适的金属(例如，不锈钢)形成的外围壳体122的孔扩大，并且玻璃套筒120填充该空隙。由金属形成的引脚110最小地膨胀，并且在冷却时，玻璃套筒120围绕它们各自的引脚110和外围壳体122的孔提供压缩密封。如图8所示，引脚110联接到挠性电缆65，挠性电缆又联接到远侧线束组合件64。
参考图13，凹穴104还包括沿着凹穴104的整个周边的台阶124。台阶124的尺寸和形状对应于盖88的凸缘126，如图14和15所示，以允许形成气密密封。另外，凸缘126被配置为装配在台阶124内并且与台阶124共面。这允许凸缘126位于台阶124的平坦表面部分上。
盖88可以由与传感器主体68类似的材料形成。盖88可以以任何合适的方式固定到传感器主体68，以确保信号处理电路90被气密地密封在盖88内。在实施例中，盖88和传感器主体68可以由诸如不锈钢的金属形成，并且盖88可以围绕它们各自的周边焊接(例如，通过激光)到平台70。盖88可以使用深拉工艺制造，这提供了经济的制造。在实施例中，可以使用诸如机械加工、金属注射成型、3-D打印之类的任何合适方法制造传感器主体68和盖88。
继续参考图14和15，盖88包括顶壁89、一对相对的侧壁91a和91b，它们通过一对相对的壁93a和93b连接。壁93a和93b可以具有弓形形状以容纳信号处理电路90。在实施例中，壁89、91a、91b、93a、93b可以具有用于包围信号处理电路90的任何合适的形状。更具体地，壁89、91a、91b、93a、93b限定了内部空腔95，其装配在信号处理电路90上方。内部空腔95还可将信号处理电路90封装在热管理材料中。在实施例中，内部空腔95可以例如通过使用预定计量的注射器填充有热管理材料。然后将附接到传感器主体68的信号处理电路90插入到填充的内部空腔95中，之后如上所述将盖88固定到传感器主体68。在固定盖88之后，热管理材料可以在空腔95和与空腔95流体连通的凹穴104内流动。
参考图25和26，信号处理电路90包括具有存储设备132的控制器130，该存储设备可以是电可擦除可编程只读存储器(“EEPROM”)或任何其他合适的非易失性存储设备。控制器130可以是任何合适的微控制器或任何其他处理器，例如可从英国剑桥的ARM公司获得的
微控制器。控制器130可以包括模数转换器、数模转换器、计时器、时钟、看门狗计时器以及其他使控制器130能够处理来自负荷感测装置102的模拟测量信号的功能组件。特别地，控制器130被配置为放大来自负荷传感器电路86的负荷感测装置102的信号，对模拟信号进行滤波，并将模拟信号转换为数字信号。控制器130还被配置为将数字信号传输至手柄组合件20的主控制器38，该主控制器基于指示所感测到的机械负荷的数字信号控制手术装置10的操作。
控制器130是可编程的，以允许对用于处理模拟信号的增益和偏移参数进行调整。特别地，控制器130在存储设备132中存储零平衡值以及相应的增益和偏移参数。在负荷感测组合件66组装之后，负荷传感器电路86被校准。在实施例中，可以周期性地重新校准负荷传感器电路86以确保精确的测量。校准可以在零平衡下执行，即，当负荷传感器电路86被卸载时。如果负荷传感器电路86即使在未加载状态下也正在输出任何信号，或者相反地，响应于加载状态未输出足够的信号，则对控制器130进行编程以补偿这种差异。这通过调节控制器130的增益和偏移参数来实现，这允许控制器130调节模拟信号以对应于零平衡状态。可以通过主控制器38对控制器130进行编程，如上所述，主控制器38通过引脚110联接至控制器130。
应理解，可对目前公开的适配器组合件的实施例进行各种修改。因此，以上描述不应解释为限制性的，而仅仅是作为实施例的例证。本领域的技术人员将设想在本公开的范围和精神内的其它修改。
Claims (13)
1.一种适配器组合件，其包括：
管状壳体，所述管状壳体具有近端部分和远端部分并且限定纵向轴线；和
负荷感测组合件，其布置在所述管状壳体内，在近侧表面和远侧表面之间接触，所述近侧表面和所述远侧表面中的每一个均垂直于所述纵向轴线，所述负荷感测组合件配置成测量施加在所述管状壳体上的负荷，所述负荷感测组合件包括传感器主体，其中所述近侧表面或所述远侧表面中的至少一个包括第一表面特征，并且所述传感器主体包括与第一表面特征接合的第二表面特征。
2.根据权利要求1所述的适配器组合件，其中所述第一表面特征是凸表面特征和所述第二表面特征是凹表面特征。
3.根据权利要求2所述的适配器组合件，其中所述第一表面特征是具有第一弯曲横截面的脊突。
4.根据权利要求3的适配器组合件，其中所述第二表面特征是具有第二弯曲横截面的凹槽。
5.根据权利要求4所述的适配器组合件，其中所述第一弯曲横截面和所述第二弯曲横截面具有相同的半径。
6.根据权利要求5所述的适配器组合件，其中所述传感器主体被配置成绕着横向于所述传感器主体限定的纵向轴线的枢转轴线枢转。
7.根据权利要求6所述的适配器组合件，其中所述枢转轴线由所述脊突限定并且穿过第一弯曲横截面和第二弯曲横截面的每个中心。
8.根据权利要求1所述的适配器组合件，其中所述第一表面特征是凹表面特征和所述第二表面特征是凸表面特征。
9.根据权利要求8所述的适配器组合件，其中所述第一表面特征是具有第一弯曲横截面的凹槽。
10.根据权利要求9的适配器组合件，其中所述第二表面特征是具有第二弯曲横截面的脊突。
11.根据权利要求10所述的适配器组合件，其中所述第一弯曲横截面和所述第二弯曲横截面具有相同的半径。
12.根据权利要求11所述的适配器组合件，其中所述传感器主体被配置成绕着横向于所述传感器主体限定的纵向轴线的枢转轴线枢转。
13.根据权利要求6所述的适配器组合件，其中所述枢转轴线由所述脊突限定并且穿过第一弯曲横截面和第二弯曲横截面的每个中心。
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| US16/790,327 | 2020-02-13 | ||
| US16/790,327 US11219461B2 (en) | 2019-03-08 | 2020-02-13 | Strain gauge stabilization in a surgical device |
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| Publication number | Publication date |
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| EP3705057A1 (en) | 2020-09-09 |
| EP3705057B1 (en) | 2023-08-23 |
| US20200281597A1 (en) | 2020-09-10 |
| US11219461B2 (en) | 2022-01-11 |
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