CN102781351A - 具有梳状组织修剪装置的超声外科器械 - Google Patents

具有梳状组织修剪装置的超声外科器械 Download PDF

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CN102781351A
CN102781351A CN201180009415XA CN201180009415A CN102781351A CN 102781351 A CN102781351 A CN 102781351A CN 201180009415X A CN201180009415X A CN 201180009415XA CN 201180009415 A CN201180009415 A CN 201180009415A CN 102781351 A CN102781351 A CN 102781351A
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T·G·戴茨
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Abstract

在一个整体方面，各种实施例涉及具有超声刀片的超声外科器械，所述超声刀片从至少一个超声换能器伸出，所述超声换能器可动地支撑在柄部外壳内。所述超声刀片通过连接到所述柄部外壳的外部套管组件伸出。所述外部套管的远端部分具有至少一个在其上形成的梳状部分。在一些实施例中，所述超声刀片的远端能够靠近所述至少一个梳状部分轴向运动。在其他实施例中，所述超声刀片的所述远端能够靠近所述至少一个梳状部分旋转。

Description

具有梳状组织修剪装置的超声外科器械
背景技术
本发明整体涉及超声外科系统，更具体地讲，涉及允许外科医生执行组织切割和凝固的超声系统。
多年以来，人们已开发出许多不同类型的非超声动力的切割器和剃刮装置以施行外科手术。其中一些装置使用旋转式切割器械而其他装置使用往复式切割构件。例如，剃刀被广泛使用在关节镜外科手术中。这些装置通常由电源、手持件和一次性端部执行器构成。端部执行器通常具有内管和外管。内管相对于外管转动并以其锋利刀刃切割组织。内管可连续转动或摆动。然而，这些装置通常不能凝固组织，并且它们通常不适用于修剪软骨结构。
希望提供克服当前器械的某些缺陷的超声外科器械。本文所述的超声外科器械克服了许多这些缺陷。
上述讨论仅仅为了举例说明技术领域内目前存在的一些不足，而不应看作是对权利要求范围的否定。
发明内容
在一个整体方面，各种实施例涉及可包括柄部外壳的超声外科器械，所述柄部外壳具有从其伸出的外部套管组件。外部套管组件可以具有至少一个远端部分，所述远端部分具有从其伸出的至少两个间隔开的齿构件。至少一个超声换能器能够由柄部外壳可动地支撑。超声刀片可以从至少一个超声换能器伸出，使得其能够随之运动。超声刀片可以具有靠近外部套管组件的至少一个远端部分运动的远端。驱动系统可以与至少一个超声换能器组件交互作用，用于向其选择性施加致动运动，以引起至少一个超声换能器组件在柄部外壳内运动。
结合本发明的另一个整体方面，提供了可包括柄部外壳的超声外科器械，所述柄部外壳具有从其伸出的外部套管组件。外部套管组件可以具有一对间隔梳状构件，每个梳状构件具有从其伸出的至少两个间隔开的齿构件。至少一个超声换能器能够由柄部外壳可动地支撑，便于在柄部外壳中选择性轴向行进。超声刀片可以从至少一个超声换能器伸出，并且能够随之轴向运动。超声刀片可具有能够在一对间隔梳状构件之间运动的远端。触发器可操作地连接到柄部组件，并且能够与至少一个超声换能器交互作用，以向其选择性施加轴向致动运动。
结合本发明的又一个整体方面，提供了可包括柄部外壳的超声外科器械，所述柄部外壳具有从其伸出的外部套管组件。外部套管组件可以包括一对间隔梳状构件，每个梳状构件具有从其伸出的至少两个间隔开的齿构件。至少一个超声换能器可旋转地支撑在柄部外壳内。超声刀片可以从至少一个超声换能器伸出，并且能够随之旋转。超声刀片可具有用于在一对间隔梳状构件之间旋转的远端。触发器可操作地连接到柄部组件，并且与一系列齿轮交互作用，该系列齿轮与至少一个超声换能器和触发器接合，使得触发器的致动引起该系列齿轮向至少一个超声换能器施加旋转运动。
附图说明
各种实施例的特征在所附权利要求书中进行了特别描述。然而结合以下描述和如下附图才能最好地理解多个实施例(有关手术的组织和方法)以及其他目的和优点。
图1是本发明的非限制性外科器械的平面图；
图2是图1的外科器械的局部剖视图；
图3是本发明的非限制性外部套管组件与超声刀片构造的端视图；
图4是本发明的非限制性超声刀片实施例远端部分的局部侧正视图；
图5是图4的超声刀片远端部分的平面图；
图6是本发明的非限制性外部套管与超声刀片构造的局部平面图；
图7是本发明的另一个非限制性外科器械实施例的局部剖视图，为了清楚起见，省略了部分驱动系统；
图8是图7的外科器械实施例的另一个剖视图；
图9是本发明的非限制性外部套管与超声刀片构造的剖视图；
图10是图9的外部套管与超声刀片构造的一部分的侧正视图；
图11是本发明的另一个非限制性外部套管与超声刀片构造的剖视图；
图11A是本发明的另一个非限制性超声刀片构造的剖视图；
图11B是本发明的另一个非限制性超声刀片构造的剖视图；
图12是本发明的另一个非限制性外部套管与超声刀片构造的末端正视图；以及
图13是图12的外部套管与超声刀片构造的侧正视图。
具体实施方式
本专利申请的所有者也拥有与本专利同一日期提交的以下美国专利申请，这些专利以引用方式相应地全部并入本文：
名称为“ULTRASONICALLY POWERED SURGICAL INSTRUMENTSWITH ROTATING CUTTING IMPLEMENT”(具有旋转切割工具的超声动力外科器械)、代理人案卷号为END6688USNP/090341的美国专利申请No._________；
名称为“METHODS OF USING ULTRASONICALLY POWEREDSURGICAL INSTRUMENTS WITH ROTATABLE CUTTINGIMPLEMENTS”(使用具有旋转切割工具的超声动力外科器械的方法)、代理人案卷号为END6689USNP/090342的美国专利申请No.________；
名称为“SEAL ARRANGEMENTS FOR ULTRASONICALLYPOWERED SURGICAL INSTRUMENTS”(超声动力外科器械的密封构造)、代理人案卷号为END6690USNP/090343的美国专利申请No._______；
名称为“ULTRASONIC SURGICAL INSTRUMENTS WITHROTATABLE BLADE AND HOLLOW SHEATH ARRANGEMENTS”(具有可旋转刀片和中空套管构造的超声外科器械)、代理人案卷号为END6691USNP/090344的美国专利申请No._________；
名称为“ROTATABLE CUTTING IMPLEMENT ARRANGEMENTSFOR ULTRASONIC SURGICAL INSTRUMENTS”(超声外科器械的可旋转切割工具构造)、代理人案卷号为END6692USNP/090345的美国专利申请No.________；
名称为“ULTRASONIC SURGICAL INSTRUMENTS WITHPARTIALLY ROTATING BLADE AND FIXED PAD ARRANGEMENT”(具有部分旋转刀片和固定垫片构造的超声外科器械)、代理人案卷号为END6693USNP/090346的美国专利申请No._______；
名称为“DUAL PURPOSE SURGICAL INSTRUMENT FOR CUTTINGAND COAGULATING TISSUE”(用于切割和凝固组织的两用外科器械)、代理人案卷号为END6694USNP/090347的美国专利申请No._______；
名称为“OUTER SHEATH AND BLADE ARRANGEMENTS FORULTRASONIC SURGICAL INSTRUMENTS”(超声外科器械的外部套管和刀片构造)、代理人案卷号为END6695USNP/090348的美国专利申请No._______；以及
名称为“ULTRASONIC SURGICAL INSTRUMENTS WITH MOVINGCUTTING IMPLEMENT”(具有运动切割工具的超声外科器械)、代理人案卷号为END6687USNP/090349的美国专利申请No.________。
各种实施例涉及用于处理组织的设备、系统和方法。示出了许多特定的细节，从而得到对说明书中所述和附图中所示的实施例的整体结构、功能、制造和用途的彻底理解。然而，本领域技术人员将会理解，可以在没有这样的特定细节的情况下实施该实施例。在其他实例中，没有详细描述熟知的操作、部件和元件，以免使说明书中描述的实施例模糊不清。本领域普通技术人员将会理解，本文所述和所示的实施例是非限制性的实例，从而可以认识到，本文所公开的特定结构和功能细节可能是代表性的，并且不必限制实施例的范围，实施例的范围仅仅由所附的权利要求限定。
本说明书通篇引用的“各种实施例”、“一些实施例”、“一个实施例”或“实施例”等，意味着结合所述实施例描述的具体特征、结构或特性包括在至少一个实施例中。因此，本说明书通篇出现的短语“在各种实施例中”、“在一些实施例中”、“在一个实施例中”或“在实施例中”等并不一定都指相同的实施例。此外，在一个或多个实施例中，可按照任何合适的方式组合具体特征、结构或特性。因此，在没有限制的情况下，结合一个实施例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它实施例的特征、结构或特性结合。
多个实施例涉及能够在外科手术期间施行组织解剖、切割和/或凝固的改良超声外科系统和器械以及因而所采用的切割工具。在一个实施例中，超声外科器械设备能够用于开放性外科手术，但所述设备也可应用于其他类型的手术(诸如关节镜、腹腔镜、内窥镜和机器人辅助手术)。超声能量的选择性使用、切割/凝固工具和/或保护性套管的选择性旋转有利于多用途使用。
应当理解，本文使用的术语“近端”和“远端”是相对于紧握手持件组件的临床医生而言的。因此，端部执行器相对于较近的手持件组件而言处于远端。还应当理解，为方便和清晰起见，本文根据临床医生紧握手持件组件的情况也使用诸如“顶部”和“底部”、“上部”和“下部”之类的空间术语。然而，外科器械在多个取向和位置中使用，并且这些术语并非意图进行限制，也并非绝对。
图1和2示出了本发明的外科器械10，该外科器械包括柄部外壳12，该柄部外壳可包括把手部分14和活动触发器20形式的驱动系统。在各种实施例中，外壳12可以两个或更多个通过紧固件(例如螺钉、按扣结构等)连接在一起的部分提供，并且能够由例如聚碳酸酯、聚醚酰亚胺(GEUltem
Figure BPA00001596271200051
)或金属(例如铝、钛或不锈钢)制成。超声换能器组件30可动地支撑在外壳12内，用于将电能转化为机械能，从而引起换能器组件30末端的纵向振动运动。超声换能器组件30可包括至少一个、优选地例如四至八个陶瓷压电元件或“超声换能器”32的叠堆，其运动零点在沿着该叠堆的某一点处。超声换能器组件30还可包括超声喇叭件34，所述喇叭件在一侧连接到零点处，并且在另一侧连接到联轴器36。
能够由例如钛制成的超声刀片40可以固定到联轴器36。在可供选择的实施例中，超声刀片40可与超声喇叭件34整体地形成。在任何一种情况下，超声刀片40都将与超声换能器组件30一起以超声频率在纵向上振动。当超声换能器组件30以换能器谐振频率和最大电流驱动时，超声换能器组件30的末端实现最大运动而叠堆的一部分构成无运动节点。然而，提供最大运动的电流将随各器械而变化，并为存储在器械的非易失性存储器中因而系统可以使用的值。
可设计超声器械10的部件使得其组合将以相同的谐振频率摆动。尤其是，可调整元件使得每个此类元件的所得长度为波长的二分之一或其倍数。随着更靠近声学安装喇叭件34的超声刀片40的直径减小，纵向往复运动增大。因而，可制定超声喇叭件34以及刀片/联轴器的形状和尺寸以便扩大刀片运动并提供与声学系统其余部分谐振的超声振动，其使靠近超声刀片40的声学安装喇叭件34的末端产生最大往复运动。压电元件32处20至25微米的运动可通过喇叭件34扩大为约40至100微米的超声刀片运动。
超声换能器组件可连接到超声控制信号源，所述源可包括常规超声发生器50。在多种实施例中，超声发生器50可包括超声发生器模块52和信号发生器模块54。参见图2。超声发生器模块52和/或信号发生器模块54可各自与超声发生器50整体地形成，或可作为电连接到超声发生器50的单独的电路模块而提供(显示为虚线，以示出此选择)。在一个实施例中，信号发生器模块54可与超声发生器模块52整体地形成。超声发生器50可包括位于发生器50控制台的前面板上的输入装置56。输入装置56可包括以已知方式产生适于对发生器50的操作进行编程的信号的任何合适装置。超声发生器50可通过线缆58连接到外科器械10。线缆58可包括多个电导体，所述电导体用于将电能应用至超声换能器组件30的正(+)电极和负(-)电极。
已知多种形式的超声发生器、超声发生器模块和信号发生器模块。例如，此类装置在2007年7月15日提交的名称为“Rotating TransducerMount For Ultrasonic Surgical Instruments”(超声外科器械的旋转换能器架)的共同拥有的美国专利申请No.12/503,770中有所公开。其他此类装置在以下全部以引用方式并入本文的一个或多个美国专利中有所公开，所述美国专利有：美国专利No.6,480,796(“Method for Improving the Start Upof an Ultrasonic System Under Zero Load Conditions”(在零负载条件下改进超声系统的启动的方法))；美国专利No.6,537,291(“Method forDetecting a Loose Blade in a Handle Connected to an Ultrasonic SurgicalSystem”(在连接至超声外科系统的柄部中检测松懈的刀片的方法))；美国专利No.6,626,926(“Method for Driving an Ultrasonic System toImprove Acquisition of Blade Resonance Frequency at Startup”(驱动超声系统以在启动时改进对刀片谐振频率的获取的方法))；美国专利No.6,633,234(“Method for Detecting Blade Breakage Using Rate and/orImpedance Information”(利用速率和/或阻抗信息检测刀片破损的方法))；美国专利No.6,662,127(“Method for Detecting Presence of a Bladein an Ultrasonic System”(在超声系统中检测刀片的存在的方法))；美国专利No.6,678,621(“Output Displacement Control Using Phase Margin in anUltrasonic Surgical Handle”(在超声外科柄部中利用相补角的输出位移控制))；美国专利No.6,679,899(“Method for Detecting TransverseVibrations in an Ultrasonic Handle”(在超声柄部中检测横向振动的方法))；美国专利No.6,908,472(“Apparatus and Method for AlteringGenerator Functions in an Ultrasonic Surgical System”(在超声外科系统中改变发生器功能的设备和方法))；美国专利No.6,977,495(“DetectionCircuitry for Surgical Handpiece System”(用于外科手持件系统的检测电路))；美国专利No.7,077,853(“Method for Calculating TransducerCapacitance to Determine Transducer Temperature”(计算换能器电容以确定换能器温度的方法))；美国专利No.7,179,271(“Method for Driving anUltrasonic System to Improve Acquisition of Blade Resonance Frequency atStartup”(驱动超声系统以在启动时改进对刀片谐振频率的获取的方法))；以及美国专利No.7,273,483(“Apparatus and Method for AlertingGenerator Function in an Ultrasonic Surgical System”(在超声外科手术系统中警示发生器功能的设备和方法))。
在多种实施例中，脚踏开关或其他开关构造60也可用于控制施加到超声换能器组件30的电力。当电力通过操作脚踏开关60或其他开关构造而施加到超声换能器组件30时，超声发生器50可(例如)使超声刀片40以大约55.5kHz的频率在纵向上振动，并且纵向运动的量将随所应用的(如通过用户可调节地选择的)电力(电流)的量成比例地变化。当应用相对高的电力时，可设计超声刀片40按超声振动速率在约40至100微米的范围内纵向运动。刀片40的该超声振动将在刀片接触组织时产生热量，即通过组织的超声刀片40的加速将运动超声刀片40的机械能在非常狭窄而局限的区域中转换成热能。该局部热量产生狭窄的凝结区域，这将减少或消除小血管的出血，诸如直径小于一毫米的那些血管。超声刀片40的切割效率以及止血程度将随应用的驱动电力水平、外科医生施加给刀片的切割速率或力度、组织类型的性质和组织的血管分布而变化。
当进行软骨的关节镜切割时，软骨的卷须通常需要修剪成与软骨结构整体解剖的表面对齐。本发明的多种实施例还将梳状结构或外部套管组件80用于捕获软骨卷须，所述捕获的方式可允许超声刀片40有利地剪断卷须。如本文所用，术语“梳状”是指具有多个(至少两个)间隔一定距离的齿构件的结构。如下面所进一步阐述，齿构件可类似于头发梳的齿，或在可供选择的实施例中，齿状构件可以在结构中心轴线的相对侧伸出。如本文所用，术语“梳状”不旨在涵盖其上具有标准凸边或粗糙区域的刀片和/或套管部件，术语“梳状”也不旨在涵盖有棱纹的套管或有棱纹的管材。
仍然参见图1和2，在一个实施例中，外部套管组件80可包括远端部分，该远端部分包括至少一个、优选地两个梳状构件，该梳状构件用于将软骨卷须捕获和定位在适当位置，其中它们可以随着超声刀片40向其邻近处轴向运动而剪断。所描述的实施例(例如)包括上部梳状构件82和下部梳状构件84，该下部梳状构件与上部梳状构件82间隔开，以在其间滑动地接纳超声刀片40。上部梳状构件82和下部梳状构件84可以由例如整体构件制成，所述整体构件由聚醚醚酮(PEEK)、Ultem
Figure BPA00001596271200091
或填充聚合物例如玻璃填充尼龙(如Grivory)制得，并且每个梳状构件具有一系列伸出的齿构件，所述齿构件被开口分隔，使得从上面观察时(图1)，上部和下部梳状构件82、84彼此基本上相同。作为另外一种选择，梳状构件可以由聚合物例如特氟隆制成，并面向超声构件，该超声构件由刚性外部金属构件支撑，该金属构件机械支撑聚合物构件。
例如，从图1中可以看出，上部和下部梳状构件82、84中的每个都具有一系列在其中形成的三个齿构件86、92和98。然而，在不脱离本发明精神和范围的情况下，其他实施例可具有少至两个齿构件或多于三个齿构件。齿构件可以在中心轴线A-A的同侧伸出，或它们可以交替从中心轴线A-A的两侧伸出。在所描述的实施例中，第一或最远侧齿构件86在其中具有第一开口88，使得第一齿构件86可具有钩状外形。第一齿构件86的第一基座部分90位于外部套管组件80限定的中心轴线A-A的第一侧面上。第二齿构件92具有位于中心轴线A-A的第二侧面上的第二基座部分94。第二齿构件92内还具有第二开口96，其开口方向为中心轴线A-A的第一侧面。第三齿构件98具有位于中心轴线A-A的第一侧面上的第三基座部分100。第三齿构件98内还具有第三开口102，其开口方向为中心轴线A-A的第二侧面。此外，第四开口104将第三齿98与相应上部和下部梳状构件82、84的末端106分隔开。例如，在图1示出的实施例中，齿构件以螺线型构造取向。此外，从图4和5中可以看出，超声刀片40的远端42可以是基本上平面的，并且其中可以形成弓形凹陷44，该凹陷用于接触贯穿各种齿构件之间开口的卷须。
如上指出，超声换能器组件30可动地支撑在柄部外壳12内。在各种实施例中，柄部外壳12可构造为支撑换能器组件30，以用于沿轴A-A的选择性“整体轴向运动”。如本文所用，术语“整体轴向运动”不旨在涵盖仅仅由向超声换能器施加超声控制信号而引起的轴向或纵向运动。如本文所用，术语“整体轴向运动”涵盖通过适当驱动系统向超声换能器组件施加力或轴向运动引起的轴向运动。例如，在所描述的实施例中，驱动系统包括可枢转地连接到柄部外壳12的可人工致动的触发器20。触发器20其上可形成有轭22，用于与凸缘21接合，该凸缘居中位于换能器组件30上的节点“N”，使得当使用者朝着和远离把手部分14绕枢轴转动触发器20时，超声换能器组件30及连接于其上的超声刀片40轴向往复运动。因此，在使用中随着超声刀片40在上部和下部梳状构件82、84之间轴向运动，软骨卷须可捕获在齿之间的开口中。上部和下部梳状构件82、84提供相对的剪切刃口，配合超声刀片40的远端42剪断捕获的卷须。
图6描述了可连接到外壳12并且以类似于上述外部套管组件80的方式发挥功能的替代外部套管组件110。外部套管组件110可具有远端部分，所述远端部分包括上部梳状构件112和下部梳状构件114，所述下部梳状构件与上部梳状构件112分隔开以接纳滑动超声刀片40插入其间。上部梳状构件112和下部梳状构件114可以由例如聚醚醚酮(PEEK)、Ultem
Figure BPA00001596271200101
或填充聚合物例如玻璃填充尼龙(如Grivory)制成，并且每个梳状构件具有一系列齿构件，所述齿构件被开口分隔，使得从上面观察时，上部和下部梳状构件112、114彼此基本上相同。例如，从图6中可以看出，上部和下部梳状构件112、114中的每个都具有一系列在其中形成的三个齿构件116、122和128。然而，在不脱离本发明精神和范围的情况下，其他实施例可具有少至两个齿构件或多于三个齿构件。在所描述的实施例中，第一或最远侧齿构件116通过第一开口120与第二齿构件118分隔。第二齿构件118通过第二开口124与第三齿构件122分隔。第三齿构件122通过开口128与相应上部和下部梳状构件112、114的端部126分隔。从图6中可以看出，所有开口120、124、128位于中心轴线A-A的第一侧面。作为另外一种选择，梳状构件可以由聚合物例如特氟隆制成，并面向超声构件，该超声构件由刚性外部金属构件支撑，该金属构件机械支撑聚合物构件。
图7和8示出了本发明的另一种外科器械200，该外科器械包括柄部外壳212，该柄部外壳可包括把手部分214和活动触发器220，其目的将在下面更详细地描述。在各种实施例中，外壳212可以两个或更多个通过紧固件(例如螺钉、按扣结构等)连接在一起的部分提供，并且能够由例如可注模聚合物如玻璃填充聚碳酸酯制成。压电超声换能器组件230可动地支撑在外壳212内，用于将电能转化为机械能，从而引起换能器组件30末端的纵向振动运动。超声换能器组件230可包括至少一个、优选地例如四个陶瓷压电元件232的叠堆，其运动零点在沿着该叠堆的居中位置。超声换能器组件230还可包括超声喇叭件234，所述喇叭件在一侧连接到零点处，并且在另一侧连接到联轴器236。能够由例如钛、铝或其他低声阻尼材料制成的超声刀片300可以固定到联轴器236。在可供选择的实施例中，超声刀片300可与超声喇叭件234整体地形成。
超声换能器组件230可支撑在换能器外壳240内，而换能器外壳可动地支撑在外壳212内。在各种实施例中，换能器外壳240能够由例如铝或优选地具有高变形温度和高热导率的材料制成，并且能够可旋转地支撑柄部外壳212内的超声换能器组件230。例如，在一个实施例中，换能器外壳240的近端242可具有从其伸出的轴244，所述轴被接纳在轴承246内，所述轴承支撑在外壳212内。此外，换能器外壳240的近端248可具有在其上形成的凸缘250，所述凸缘能够可旋转地接纳在外壳212中形成的凹槽252内。超声喇叭件234和联轴器236通过换能器外壳240中的开口254伸出。因此，换能器外壳240能够在柄部外壳212内绕轴A-A旋转。
在各种实施例中，超声换能器组件230通过滑环构造260从超声控制信号源50获得超声控制信号。更具体地讲，从图7和8中可以看出，第一接触环262可以安装到换能器外壳240的周边，并且通过导体264连接到换能器组件230。相似地，第二接触环266可以安装到换能器外壳240的周边，并且通过导体266连接到换能器组件。第一接触环262定位为与第一固定触头270滑动旋转接触，所述第一固定触头固定地安装在柄部外壳212内，并且通过导体272与超声发生器50连通。同样，第二接触环266定位为与第二固定触头274滑动旋转接触，所述第二固定触头通过导体276与超声发生器50连通。此类滑动环构造260有利于将来自超声发生器50的超声控制信号施加到超声换能器组件230，同时使超声换能器组件230能够绕轴A-A旋转。也可以使用其他滑动环构造。
换能器外壳240和换能器组件230绕中心轴线A-A的选择性“整体旋转”可通过人工致动的驱动系统(笼统地指定为280)实现。如本文所用，术语“整体旋转”是指由驱动系统施加旋转致动运动或力所引起的超声换能器组件和超声刀片的旋转，并且不旨在涵盖超声换能器组件可能受到的仅通过向其施加超声控制信号而产生的旋转运动。例如，在各种实施例中，驱动系统280可包括安装到换能器外壳240周边的第一齿轮282。第一齿轮282可与居中安装到换能器叠堆的凸缘(未示出)接合，所述换能器叠堆包括超声换能器组件230。因此，凸缘和第一齿轮282位于换能器组件230上的节点“N”。第一齿轮282可与第二传动齿轮284啮合，所述第二传动齿轮由柄部外壳212可旋转地支撑。例如，第二传动齿轮284的轴颈可旋转地支撑在销286上，所述销从柄部外壳212的部分向内伸出。驱动系统280还可以包括与第二传动齿轮284啮合、并且连接到触发器220的第三传动齿轮288。触发器220可绕销222枢转地安装到柄部外壳212，使得触发器220可相对于把手部分214绕枢轴转动，如图8中的箭头所示出。因此，通过使触发器220相对于把手214绕枢轴转动，使用者可使换能器外壳240绕中心轴线A-A旋转。
同样在各种实施例中，超声刀片300可通过外部套管310旋转地伸出，所述外部套管连接到柄部外壳212或从中伸出。在一些实施例中，外部套管310能够由例如聚醚醚酮(PEEK)、Ultem
Figure BPA00001596271200121
或填充聚合物例如玻璃填充尼龙(如Grivory)制成，并且具有梳状远端部分312。作为另外一种选择，梳状构件可以由聚合物例如特氟隆制成，并面向超声构件，该超声构件由刚性外部金属构件支撑，该金属构件机械支撑聚合物构件。超声刀片300可通过一个或多个密封件311旋转地支撑在外部套管310内，所述密封件位于沿着超声刀片300的一个或多个节点处。在各种实施例中，可使用名称为“SEAL ARRANGEMENTS FOR ULTRASONICALLY POWEREDSURGICAL INSTRUMENTS”(超声动力外科器械的密封构造)、代理人案卷号为END6690USNP/090343的共同未决的美国专利申请No._________中所描述的类型的一种或多种密封件311，该专利全文以引用方式并入本文。然而，也可使用其他密封件构造。从图9和10中可以看出，梳状远端部分312可形成弓形托架314，所述弓形托架在间隔开的梳状齿318的第一侧面系列316和间隔开的梳状齿326的第二侧面系列324之间分隔开。在各种实施例中，齿318的第一侧面系列316包括至少两个间隔距离320的齿318。可使用其他多个齿318。齿326的第二系列324包括与齿318的数量匹配、并且基本上与其横向对齐的多个齿326。齿326可通过所示出的开口328分隔。
从图7-10中还可以看出，超声刀片300可以具有远端部分304，所述远端部分的横截面大于刀片300的细长主体部分302。尤其是从图9中可以看出，远端部分304相对于主体部分302偏心安装。远端部分304的各种旋转位置在图9中以虚线显示。图11示出了可供选择的超声刀片实施例，其中远端304’具有椭圆形横截面形状。图11A和11B示出了其他超声刀片实施例，其中远端304”具有椭圆形横截面形状，其上形成有切割齿或凹口305。凹口可为精密加工的脊，使超声手术中刃口的有效锋利程度在制造期间设定。图12和13示出了可供选择的外部套管310’与超声刀片构造300”。从这些图中可以看出，齿318’、326’的系列316’、324’更长，并且在其间形成槽314’。第一齿318’通过开口320’分隔，第二齿326’通过开口328’分隔。超声刀片300”的远端304”具有基本上圆形的横截面，该横截面大小可旋转地贴合在槽314’中。
在使用中，临床医生可使外部套管310的远端312接触要切割的软骨。可将超声电力施加到超声换能器组件230和超声刀片230。然后，临床医生可将触发器220相对于把手214绕枢轴转动，使超声刀片230旋转。当超声刀片300的远端部分304在托架314内旋转时，刀片300的远端304可接触刀片架，使各种卷须在齿的系列316、324之间“梳理”，并且通过刀片300的有动力远端部分304切割。在可供选择的实施例中，临床医生可在向其施加超声运动之前旋转超声刀片300。
可将本发明所公开的装置设计为单次使用后即进行处理，或者可将它们设计为可多次使用。然而在任一种情况下，该装置均可重新恢复，以在至少一次使用后再次使用。重新恢复可包括如下步骤的任意组合：拆卸该装置、然后清洗或置换某些部分以及随后组装。特别是，该装置可以拆卸，并且可以任意组合选择性地置换或移除任意数目的某些部分或零件。清洗和/或置换某些部分后，该装置可以在重新恢复设施处重新组装以随后使用，或者在即将进行外科手术操作前由外科手术队组装。本领域的技术人员将会知道，装置的重新恢复可利用多种用于组装、清洁/置换和重新组装的技术。这些技术的使用以及所得的修复装置均在本发明的范围内。
优选地，在外科手术前实施本文所述的各种实施例。首先，获取新的或用过的装置，并在必要时对装置进行清洁。然后对装置进行消毒。在一种消毒技术中，将该装置置于闭合并密封的容器中，例如塑料或TYVEK袋中。然后将容器和装置置于能够穿透该容器的辐射区，例如γ辐射、x-射线或高能电子。辐射将装置上和容器中的细菌杀死。然后将灭菌后的装置保存在消毒容器中。该密封容器将器械保持无菌，直到在医疗设备中打开该容器。消毒也能够通过本领域技术人员已知的任何种方式进行，包括β辐射或γ辐射、环氧乙烷和/或蒸汽消毒。
在各种实施例中，可将下述超声外科器械提供给外科医生，其中波导和/或端部执行器已可操作地连接外科器械的换能器。在至少一个此类实施例中，外科医生或其他临床医生可从消毒包中移出超声外科器械、将该超声器械插入到发生器中(如上文所概述)、并且在外科手术操作期间使用该超声器械。这种系统可无需外科医生或其他临床医生动手而将波导和/或端部执行器装配至超声外科器械。在已使用超声外科器械之后，外科医生或其他临床医生可将超声器械置于可密封包中，其中可将所述包运送至消毒设施。在消毒设施处，可对超声器械消毒，其中任何耗费部件都可被丢弃和更换，任何可重复使用的部件都可被消毒和再次使用。其后，超声器械可进行重新组装、测试、置于消毒袋中和/或在置于消毒袋中之后进行消毒。一旦经过消毒，该重新处理的超声外科器械就可再次使用。
虽然本文已描述了多种实施例，但可以对这些实施例进行多种修改和变型。例如，可采用不同类型的端部执行器。另外，凡是公开了用于某些元件的材料的，均可使用其他材料。上述具体实施方式和下述权利要求旨在涵盖所有这样的修改和变型形式。
本说明书中涉及的所有上述美国专利和美国专利申请和公布的美国专利申请全文以引用方式并入本文中，但仅限于所并入的材料与本发明所述的现有定义、陈述或其他公开材料没有冲突。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了以引用方式并入本文的任何冲突材料。如果任何材料或其部分据述以引用方式并入本文，但与本文所述的现有定义、陈述或其他公开材料相冲突，那么仅在所并入的材料和现有公开材料之间不产生冲突的程度下才将其并入本文。

Claims (20)

1.一种超声外科器械，包括：
柄部外壳；
从所述柄部外壳伸出的外部套管组件，所述外部套管组件具有至少一个梳状远端部分，所述梳状远端部分具有从其伸出的至少两个间隔开的齿构件；
由所述外壳可动地支撑的至少一个超声换能器；
从所述至少一个超声换能器伸出并且能够随之运动的超声刀片，所述超声刀片具有靠近所述外部套管组件的所述至少一个远端部分运动的远端；以及
驱动系统，所述驱动系统与所述至少一个超声换能器组件交互作用，用于向其选择性施加致动运动，以引起所述至少一个超声换能器组件在所述柄部外壳内运动。
2.根据权利要求2所述的超声外科器械，其中所述外部套管组件具有一对间隔开的梳状远端部分，所述梳状远端部分具有至少两个间隔开的齿构件，并且其中所述超声刀片的所述远端能够在所述外部套管组件的所述一对间隔开的远端部分之间运动。
3.根据权利要求1所述的超声外科器械，其中每个所述梳状远端部分上的所述至少两个间隔开的齿构件以螺线型构造取向。
4.根据权利要求1所述的超声外科器械，其中所述至少一个超声换能器可动地支撑在所述柄部外壳内，便于在其中选择性整体轴向行进。
5.根据权利要求1所述的超声外科器械，其中所述至少一个超声换能器可动地支撑在所述柄部外壳内，便于在其中选择性整体旋转。
6.根据权利要求1所述的超声外科器械，其中所述驱动系统包括触发器，所述触发器可动地连接到所述柄部外壳并且与所述至少一个超声换能器接合，使得向所述触发器施加致动运动引起所述至少一个换能器在所述柄部外壳内运动。
7.根据权利要求6所述的超声外科器械，其中所述驱动系统还包括一系列齿轮，所述齿轮与所述触发器和所述至少一个超声换能器可操作地接合。
8.根据权利要求1所述的超声外科器械，其中所述超声刀片具有细长中部，所述细长中部的横截面形状基本上是圆形，并且其中所述远端部分从所述细长中部偏心地伸出。
9.根据权利要求1所述的超声外科器械，其中所述超声刀片的所述远端基本上是平面的。
10.根据权利要求1所述的超声外科器械，其中所述超声刀片的所述远端的横截面形状基本上是圆形。
11.一种超声外科器械，包括：
柄部外壳；
从所述柄部外壳伸出的外部套管组件，所述外部套管组件具有一对间隔开的梳状构件，每个所述梳状构件具有从其伸出的至少两个间隔开的齿构件；
至少一个超声换能器，所述至少一个超声换能器能够由所述外壳可动地支撑，便于在其中选择性整体轴向行进；
从所述至少一个超声换能器伸出并且能够随之轴向运动的超声刀片，所述超声刀片具有用于在所述一对间隔开的梳状构件之间运动的远端；以及
触发器，所述触发器可操作地连接到所述柄部组件并且与所述至少一个超声换能器接合以向其选择性施加整体轴向致动运动。
12.根据权利要求11所述的超声外科器械，其中所述一对间隔开的梳状构件由聚合材料制成。
13.根据权利要求11所述的超声外科器械，其中每个所述梳状构件限定中心轴线，其中至少一个所述齿构件在所述中心轴线的一侧上伸出，并且其中另一个所述齿构件从所述中心轴线的另一侧伸出。
14.根据权利要求11所述的超声外科器械，其中所述超声刀片的所述远端基本上是平面的，并且具有在其中形成的弓形凹陷。
15.一种超声外科器械，包括：
柄部外壳；
从所述柄部外壳伸出的外部套管组件，所述外部套管组件具有一对间隔开的梳状构件，每个所述梳状构件具有从其伸出的至少两个间隔开的齿构件；
至少一个超声换能器，所述至少一个超声换能器支撑在所述柄部外壳内，便于在其中整体旋转；
从所述至少一个超声换能器伸出并且能够随之旋转的超声刀片，所述超声刀片具有用于在所述一对间隔开的梳状构件之间旋转的远端；
可操作地连接到所述柄部组件的触发器；以及
一系列齿轮，所述系列齿轮与所述至少一个超声换能器和所述触发器接合，使得所述触发器的致动引起所述系列齿轮向所述至少一个超声换能器施加整体旋转运动。
16.根据权利要求15所述的超声外科器械，其中所述至少一个超声换能器支撑在换能器外壳内，所述换能器外壳支撑在所述柄部外壳内便于整体旋转，并且其中所述系列齿轮包括：
在所述换能器外壳上支撑的第一从动齿轮；
与所述第一从动齿轮啮合的第二从动齿轮；以及
由所述触发器支撑并且与所述第二从动齿轮啮合的第三从动齿轮。
17.根据权利要求16所述的超声外科器械，还包括在超声控制信号源和所述至少一个超声换能器之间接合的滑动环组件。
18.根据权利要求17所述的超声外科器械，其中所述滑动环组件包括：
在所述柄部外壳上支撑并且与所述超声控制信号源连通的第一固定触头；
在所述柄部外壳上支撑并且与所述超声控制信号源连通的第二固定触头；
在所述换能器外壳上的第一可动触头，所述第一可动触头在运动中接触所述第一固定触头，并且与所述至少一个超声换能器连通；以及
在所述换能器外壳上的第二可动触头，所述第一可动触头在运动中接触所述第二固定触头，并且与所述至少一个超声换能器连通。
19.根据权利要求15所述的超声外科器械，其中所述超声刀片具有细长中部，所述细长中部的横截面形状基本上是圆形，并且其中所述远端部分从所述细长中部偏心地伸出。
20.根据权利要求19所述的超声外科器械，其中所述超声刀片的所述远端部分的横截面形状是椭圆形。
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JP5766722B2 (ja) 2015-08-19
AU2011215981A1 (en) 2012-08-23
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US20110196405A1 (en) 2011-08-11

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