CN102781349A - 具有移动切割工具的超声外科器械 - Google Patents

具有移动切割工具的超声外科器械 Download PDF

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CN102781349A
CN102781349A CN2011800094126A CN201180009412A CN102781349A CN 102781349 A CN102781349 A CN 102781349A CN 2011800094126 A CN2011800094126 A CN 2011800094126A CN 201180009412 A CN201180009412 A CN 201180009412A CN 102781349 A CN102781349 A CN 102781349A
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cutter
surgical instruments
hollow sleeve
drive system
opening
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CN102781349B (zh
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T·G·迪茨
G·W·约翰逊
S·P·康伦
D·J·穆莫
J·R·摩根
W·D·丹那赫尔
O·J·瓦克哈里亚
R·W·蒂姆
M·C·米勒
G·C·罗伯特森
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Ethicon Endo Surgery Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00296—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means mounted on an endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320069—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic for ablating tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320071—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with articulating means for working tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320089—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic node location
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A61B2017/320095—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw with sealing or cauterizing means

Abstract

本发明在多种实施例中提供了一种在含水环境中操作的外科器械。在至少一个实施例中，所述外科器械可包括中空外套和至少部分地设置在所述外套内的刀具。至少一个超声换能器可连接到所述刀具，所述超声换能器可继而连接于驱动系统。所述驱动系统可被构造成将全部轴向运动传递给所述刀具，使得当所述驱动系统被启动时所述刀具相对于所述中空外套平移。因此，组织可由所述刀具以刀具的全部轴向运动和/或由所述超声换能器提供的超声振动进行切割。在可供选择的实施例中，所述刀具可轴向旋转而不是相对于所述中空外套平移。

Description

具有移动切割工具的超声外科器械
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手术中。关节镜手术涉及在关节间隙中进行外科手术。为进行该外科手术，通常在关节中填充加压的生理盐水以便扩张和可视。
上述装置通常由电源、手柄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刃口切割组织。内管可连续转动或摆动。另外，此装置可使用穿过内管内部的抽吸通道。例如，授予McGurk-Burleson等人的美国专利No.4,970,354公开了一种包括以剪切动作切割材料的旋转切割器的非超声动力外科切割器械。其使用可在外管中旋转的内部切割构件。
授予Peyman等人的美国专利No.3,776,238公开了一种眼科器械，其中通过内管尖端的劈砍动作来切割组织，该内管抵靠着外管末端的内表面而移动。授予Kajiyama等人的美国专利No.5,226,910公开了另一种具有内部构件的外科切割器械，该内部构件相对于外部构件移动，以切割穿入外部构件孔隙的组织。
授予Wuchinich等人的美国专利No.4,922,902公开了一种用超声抽吸器进行内窥镜式组织移除的方法和装置。该装置使用超声探针，该探针使适形的组织破裂并通过狭孔将其吸出。授予Spinosa等人的美国专利No.4,634,420公开了一种从动物上移除组织的装置和方法并包括具有针或探针的细长器械，该针或探针在横向上以超声频率振动。所述针的超声振动使组织裂成碎片。可通过针内导管的抽吸将组织碎片从处理区域移除。授予Banko的美国专利No.3,805,787还公开了另一种具有探针的超声器械，该探针具有遮挡部，以缩小从探针顶端发出的超声能量束。在一个实施例中，该遮挡部延伸越过探针的自由端以防止探针与组织接触。授予Davis的美国专利No.5,213,569公开了一种聚焦超声能量的超声乳化针。聚焦面可被倾斜、弯曲或小平面化。授予Wuchinich的美国专利No.6,984,220和授予Easley的美国专利公布No.US 2005/0177184公开了超声组织解剖系统，该系统通过使用纵扭共振器来提供纵向和扭转组合运动。授予Zhou等人的美国专利公布No.US 2006/0030797A1公开了一种整形外科装置，该装置具有驱动马达以驱动超声换能器和喇叭件。在驱动马达和换能器之间设有适配器以将超声能量信号提供给换能器。
虽然使用超声动力的外科器械较之于传统机械动力的锯、钻和其他器械具有若干优点，但是由于在骨头/组织界面的摩擦发热导致的骨头和相邻组织中的温度上升仍然是一个显著的问题。当前的关节镜手术工具包括冲头、往复式剃刀和射频(RF)装置。机械装置(诸如冲头和剃刀)产生最小的组织损伤，但是有时候会留下不可取的参差不齐的切割线。RF装置可产生平滑的切割线，也能消融大量的软组织；然而它们却易于造成比机械装置更多的组织损伤。因此，需要有能够在形成光滑切割表面的同时提高切割精度而不产生过多组织损伤的装置。
以上讨论仅仅意图说明本发明所属领域的现状，而不应视为是对权利要求范围的否定。
发明内容
在多种实施例中，提供了一种外科器械。在至少一个实施例中，该外科器械可包括中空外套、至少部分置于中空外套内的刀具、可操作地连接到刀具的至少一个超声换能器以及驱动系统。在这些实施例中，该驱动系统可与换能器连通以将轴向运动传递给刀具使得当驱动系统被启动时刀具相对于中空外套平移。
在至少一个实施例中，提供了一种外科器械，该外科器械可包括中空外套、至少部分置于中空外套内的刀具、连接到刀具的至少一个超声换能器以及驱动系统。在这些实施例中，该驱动系统可与换能器连通以将旋转运动传递给刀具使得当驱动系统被启动时刀具相对于中空外套旋转。另外，在这些实施例中，中空外套可包括在其中的至少一个开口和设于该开口中的至少一个齿。此外，在这些实施例中，所述齿可被构造成可夹住位于开口内的组织。
在至少一个实施例中，提供了一种外科器械，其包括：在其中包括至少一个开口的中空外套、至少部分位于中空外套内的刀具、连接到刀具的超声换能器、可由中空轴可动地支撑的组织夹持构件以及连接到组织夹持构件的驱动系统。在这些实施例中，该驱动系统可被构造成可将轴向运动传递给组织夹持构件，使得当驱动系统被启动时组织夹持构件相对于中空外套平移。
附图说明
本申请所述实施例的新颖特征在所附权利要求书中进行了详细描述。然而，对组织和操作方法的实施例而言，皆可以通过参照以下具体实施方式(结合附图)更好地理解。
图1是手术控制系统的非限制性实施例的示意图。
图1A是控制系统外壳的非限制性实施例的透视图。
图1B是控制系统外壳装置的另一个非限制性实施例的透视图。
图2是使用线性驱动系统的手持式外科器械的非限制性实施例的局部剖视图。
图3是外科器械的非限制性实施例的远侧部的俯视图。
图4是图3的外科器械的远侧部的侧剖视图。
图5是外科器械的非限制性实施例的远侧部的侧剖视图。
图6A是沿着线6A-6A截取的图5外科器械远侧部的前剖视图。
图6B是沿着线6B-6B截取的图5外科器械远侧部的另一个前剖视图。
图7A是外科器械的非限制性实施例的远侧部的侧剖视图；所述器械的刀具被示出为位于第一轴向位置。
图7B是图7A的外科器械远侧部的另一个侧剖视图；所述刀具被示出为轴向平移至第二轴向位置。
图8是图7A的外科器械的远侧部的俯视图。
图9是外科器械的非限制性实施例的远侧部的透视图。
图10A是图9外科器械的中空外套的远侧部的透视图。
图10B是图9外科器械的刀具的远侧部的透视图。
图10C是图9外科器械的剪切板的透视图。
图11是图9外科器械的远侧部的侧剖视图。
图12A-12C是图9外科器械的远侧部的一系列侧剖视图，示出了当刀具相对于中空外套平移时在不同轴向位置的刀具。
图13是用于外科器械(例如图2的外科器械)的线性驱动系统的非限制性实施例的侧视图。
图14是用于外科器械(例如图2的外科器械)的另一个线性驱动系统的非限制性实施例的侧视图。
图15是用于外科器械(例如图2的外科器械)的另一个线性驱动系统的非限制性实施例的侧视图。
图16是使用另一个线性驱动系统的外科器械的非限制性实施例的局部剖视图。
图17是在中空外套中包括多个开口的外科器械的非限制性实施例的远侧部的透视图；组织被示出为正被吸入开口。
图18是图17的外科器械的远侧部的部分剖面图，示出了带齿刀具。
图19是在中空外套中包括多个开口的外科器械的另一个非限制性实施例的远侧部的透视图。
图20A-20B是用于外科器械(例如图17-19的外科器械)的带齿刀具远侧部的侧剖视图。
图21A-21C是可与带齿刀具一起使用的各个齿的侧剖视图。
图22是使用两个抽吸内腔的外科器械的非限制性实施例的局部剖视图。
图23是图22的外科器械的远侧部的透视图。
图24A和24B是外科器械(例如图22的外科器械)的刀具远侧部的侧视图。
图25是使用旋转驱动系统的外科器械的非限制性实施例的局部剖视图。
图26是图25的外科器械的透视图。
图27是外科器械的非限制性实施例的远侧部的侧剖面图，该外科器械包括用以咬住组织的限定于中空外套开口中的齿。
图28-29是可用于外科器械(例如图27的外科器械)的一些齿的局部视图。
图30是外科器械(例如图27的外科器械)的突鼻部和关联部件的侧剖视图。
图31是包括可旋转刀具的外科器械的非限制性实施例的远侧部的侧视图。
图32是沿线32-32截取的图31外科器械的剖视图。
图33A是沿线33A-33A截取的图31外科器械刀具的剖视图。
图33B是沿线33B-33B截取的图31外科器械刀具的剖视图。
图34是用于外科器械(例如图31的外科器械)的刀具的另一个非限制性实施例的剖视图。
图35是用于外科器械(例如图31的外科器械)的刀具的另一个非限制性实施例的侧剖视图。
图36是沿线36-36截取图35刀具的剖视图。
图37是包括质量平衡刀具的外科器械的非限制性实施例的远侧部的前剖视图。
图38是包括具有螺旋面的刀具的外科器械的非限制性实施例的远侧部的俯视图。
图39是图38外科器械的刀具的远侧部的俯视图。
图40是包括可移动组织夹持构件的外科器械的非限制性实施例的局部剖视图。
图41是沿线41-41截取的图40的外科器械的中空外套、缆线和刀具的剖视图。
图42A是图40的外科器械的远侧部的透视图；组织夹持构件被示出为处于伸出位置。
图42B是图40的外科器械的远侧部的透视图；组织夹持构件被示出为处于回缩位置。
图43是沿图42A中线43-43截取的图40外科器械的中空外套、缆线和刀具的剖视图。
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，这些专利各自的全部内容以引用方式并入本文：
题为“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._______；
题为“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.________；
题为“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的美国专利申请No.__________；
题为“ULTRASONIC SURGICAL INSTRUMENTS WITH ROTATABLEBLADE AND HOLLOW SHEATH ARRANGEMENTS”(具有可旋转刀具和中空外套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.__________；
题为“ROTATABLE CUTTING IMPLEMENT ARRANGEMENTS FORULTRASONIC 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._______；
题为“ULTRASONIC SURGICAL INSTRUMENTS WITH PARTIALLYROTATING BLADE AND FIXED PAD ARRANGEMENT”(具有部分旋转刀具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._________；
题为“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.________；
题为“OUTER SHEATH AND BLADE ARRANGEMENTS FORULTRASONIC SURGICAL INSTRUMENTS”(超声外科器械的外部外套和刀具构造)、代理人案卷号为END6695USNP/090348的美国专利申请No._______；以及
题为“ULTRASONIC SURGICAL INSTRUMENT WITH COMB-LIKETISSUE TRIMMING DEVICE”(具有梳状组织修剪装置的超声外科器械)、代理人案卷号为END6686USNP/090367的美国专利申请No.________。
现在将描述某些实施例，以提供对本发明所公开的结构、功能、制造的原理、设备的用途和方法的全面理解。这些实施例的一个或多个例子在附图中示出。本领域普通技术人员将会理解，本文具体描述并在附图中示出的装置和方法是非限制性的实施例，并且这些实施例的范围完全由权利要求书来限定。结合一个实施例进行图解说明或描述的部件可以与其他实施例的部件进行组合。此外，当指出一过程中的步骤顺序时，根据需要，这样的顺序可以重新安排，或者步骤可以同时进行，除非不合逻辑或明确要求所列出的顺序。这样的修改形式和变型形式旨在纳入所附权利要求书的范围内。
在下面的描述中，在若干视图中，相同的附图标记指示相同或对应的部件。另外，在下面的描述中，应当理解，诸如“向前”、“向后”、“前”、“后”、“右”、“左”、“在…上方”、“在…下方”、“顶部”、“底部”、“向上”、“向下”、“近侧”、“远侧”等词是便利性用语，不应认为是限制性术语。下面的描述是为描述多种实施例之目的，并非意图限制所附权利要求。
各种实施例涉及被构造成适于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，超声外科器械设备被构造为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(诸如腹腔镜、内窥镜和机器人辅助手术)。有选择地使用超声能量、有选择的显著轴向移动和/或转动切割/凝固工具，以及/或者在附近和/或通过切割/凝固工具而施加的抽吸，这些有助于多方面用途的实现。
应当理解，本文使用的术语“近端”和“远端”是相对于紧握手柄组件的临床医生而言的。因此，端部执行器相对于较近的手柄组件而言处于远端。还应当理解，为方便和清晰起见，本文根据临床医生紧握手柄组件的情况也使用诸如“顶部”和“底部”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以示意方式示出了外科系统10的一个非限制性实施例。外科系统10可包括超声发生器12和超声外科器械组件100，后者包括超声产生部件。下文将更详细地讨论，超声发生器12可由电缆14连接到外科器械组件100的外壳部分102中的超声换能器组件114上。换能器组件114可包括一个或多个能够产生超声振动的超声换能器。另外，喇叭件124可连接到超声换能器组件114以放大和/或集中由换能器组件114产生的超声运动。刀具200可连接到喇叭件124，该刀具至少部分地位于从外壳部分102伸出的中空外套230内。在一个实施例中，系统10还包括马达控制系统20，该马达控制系统包括由电缆23连接到控制模块24的电源22以向其提供例如24V直流电。马达控制模块24可包括由美国国家仪器公司(NationalInstruments)制造的型号为No.NI cRIO-9073的控制模块。然而，可使用其他马达控制模块。许多电源均可有效地用作电源22。电源22还可由电缆25连接到马达驱动器26以向其提供24V直流电。马达驱动器26可包括由美国国家仪器公司(National Instruments)制造的马达驱动器。然而，其他马达驱动器也可有效使用。控制模块24也可由电缆27连接到马达驱动器26以向其提供电力。常规的脚踏开关30或其他控制开关装置可用电缆31附接于控制模块24。如在下文中进一步详细地讨论，超声外科器械100可包括驱动系统，该驱动系统可包括马达190，该马达具有与其相联的编码器194。驱动系统可通过转动-直线移动转换器150(下文说明)与换能器组件114连通，以将全部轴向运动传送至刀具200，使得当驱动系统被启动时刀具相对于中空外套平移。马达190可包括由美国国家仪器公司(NationalInstruments)制造的型号为No.CTP12ELF10MAA00的马达。然而，可使用其他马达。编码器194可包括由美国数字公司(US Digital)制造的型号为No.E2-500-197-I-D-D-B的线性编码器。然而，可使用其他马达和编码器。编码器194可通过编码器电缆32连接到马达控制模块24并且马达190可通过电缆33连接到马达驱动器26。外科系统10还可包括可通过以太网电缆42与马达控制模块24连通的计算机40。
图1中还示出，在各种实施例中，马达控制系统20可装在外壳21中。为促成系统的易携带性，多个部件可通过可移除的电缆连接器连接到马达控制系统20。例如，脚踏开关30可通过电缆35连接到可拆卸电缆连接器37，以便于将脚踏开关快速地连接到控制系统20。交流电能可通过常规的带插头电缆50提供给电源22，该常规的带插头电缆连接到可拆卸电缆连接器54而该电缆连接器又连接到电缆52。计算机40可具有连接到可拆卸电缆连接器62的电缆60，该可拆卸电缆连接器又连接到电缆42。编码器194可具有连接到可拆卸连接器72的编码器电缆70。同样，马达190可具有连接到可拆卸连接器72的电缆74。可拆卸连接器72可通过电缆32连接到控制模块24并且连接器72可通过电缆33连接到马达驱动器26。因而，电缆连接器72用于将编码器194连接到控制模块24并将马达190连接到马达驱动器26。电缆70和74可装在共同的外套76中。
在可供选择的实施例中，超声发生器12和控制系统20可装在相同的外壳105中。参见图1A。在另一个实施例中，超声发生器12可通过跨接电缆107电连接到马达控制系统20。这样的构成可共享数据链接以及共同的供电装置(电缆50)。参见图1B。
在多种实施例中，超声发生器12可包括超声发生器模块13和信号发生器模块15。参见图1。超声发生器模块13和/或信号发生器模块15可各自与超声发生器12形成为一体，或可作为电连接到超声发生器12的单独的电路模块而提供(以虚线示出此选择方案)。在一个实施例中，信号发生器模块15可与超声发生器模块13形成为一体。超声发生器12可包括位于发生器12控制台的前面板上的输入装置17。输入装置17可包括以已知方式产生适于对发生器12的操作进行编程的信号的任何合适装置。还是参照图1，电缆14可包括多个电导体(诸如铜线)以将电能施加到超声换能器组件114的正(+)和负(-)电极，下文将更详细地讨论。
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日提交的题为“Rotating Transducer MountFor 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。其他此类装置公开于以下的一个或多个美国专利(它们全部以引用方式并入本文)，所述美国专利有：美国专利No.6,480,796(“Method for Improving the Start Up of anUltrasonic 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 for Detecting aLoose Blade in a Handle Connected to an Ultrasonic Surgical System”(检测连接于超声外科系统的柄部中刀具松动的方法))；美国专利No.6,626,926(“Method for Driving an Ultrasonic System to Improve Acquisition of BladeResonance Frequency at Startup”(驱动超声系统以在启动时改进对刀具谐振频率的获取的方法))；美国专利No.6,633,234(“Method for DetectingBlade Breakage Using Rate and/or Impedance Information”(利用速率和/或阻抗信息检测刀具破损的方法))；美国专利No.6,662,127(“Method forDetecting Presence of a Blade in an Ultrasonic System”(检测超声系统中刀具存在的方法))；美国专利No.6,678,621(“Output Displacement ControlUsing Phase Margin in an Ultrasonic Surgical Handle”(超声手术手柄中利用相补角的输出位移控制))；美国专利No.6,679,899(“Method forDetecting Transverse Vibrations in an Ultrasonic Handle”(检测超声手柄中横向振动的方法))；美国专利No.6,908,472(“Apparatus and Method forAltering Generator Functions in an Ultrasonic Surgical System”(用于改变超声外科系统中发生器功能的装置和方法))；美国专利No.6,977,495(“Detection Circuitry for Surgical Handpiece System”(手术手柄系统的检测电路))；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”(用以改进启动时刀具谐振频率获取的超声系统驱动方法))；以及美国专利No.7,273,483(“Apparatus and Method for Alerting GeneratorFunction in an Ultrasonic Surgical System”(用于警示超声外科系统中发生器功能的装置和方法))。
如在图2中可见，超声外科器械100可包括装有马达190、编码器194、超声换能器组件114以及喇叭件124的外壳102。换能器组件114可通过常规直线轴承104(例如滚柱)可移动地支承于外壳102内。刀具200可从喇叭件124伸出，其穿过中空外套230直到限定在其中的窗口或开口231。如图2所示，刀具200的远端202在位于外科器械100远侧部250的开口231处可见。外壳102可以由两个或更多个部分形成，它们通过紧固件(诸如螺钉、按扣结构等)和/或通过一种或多种粘接剂连在一起，并且可由例如聚碳酸酯、不锈钢或其他材料制成。马达190可安装到外壳102中，并可通过包括齿条构件153和小齿轮154的转动-直线移动转换器150与超声换能器机械地连接。可根据需要在小齿轮154和齿条构件153之间添加额外的齿轮以实现所需的齿轮减速。另外，齿条构件153可保持编码器194并可连接到换能器组件114。因此，马达190的启动可转动小齿轮154，并因而在与中空外套的纵向轴线A-A平行或共轴的近侧方向“PD”或远侧方向“DD”上驱动齿条153、编码器194、换能器组件114、喇叭件124以及刀具200。马达190可包括(例如)由美国国家仪器公司(NationalInstruments)制造的型号为No.CTP12ELF10MAA00的步进马达。然而，其他马达(诸如无刷直流或其他类型)也可用于完成(例如)刀具200相对于中空外套230的大约1至15mm的“总”轴向移动。编码器194可将齿条构件154的位置和/或速度转换成电脉冲，所述电脉冲将位置、速度和/或其他控制信息提供给控制模块24。另外，编码器194可包括内嵌式力传感器(未示出，例如压电传感器)，其可测量刀具远端202所经受的并传递到齿条构件153的载荷，例如外科器械用于外科手术时组织所施加的载荷。
仍参见图2，超声换能器组件114可包括支承压电超声换能器115的外壳118，压电超声换能器用于将电能转换成机械能，机械能则引起换能器115末端的纵向振动。超声换能器115可包括陶瓷压电元件的叠堆，其运动零点在沿着该叠堆的某一点处。超声换能器115可被安装在近端件116和远端件117之间。此外，喇叭件124可在一侧装于零点处的远端件117上并在另一侧装于刀具200上。因此，刀具200将通过超声换能器组件114以超声频率纵向振动。当超声换能器组件114以换能器谐振频率和最大电流驱动时，超声换能器组件114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，实现最大运动的电流会随各个器械而不同，并且电流值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。
外科器械100的部件可被设计成使得其组合将以相同的谐振频率摆动。具体而言，这些元件可被调整为使得每个这种元件的所得长度为半波长或半波长的倍数。因为声学安装喇叭件124的的直径越靠近刀具200越减小，纵向的前后移动被放大。因而，喇叭件124以及刀具200的形状和尺寸可被适当确定以放大刀具移动并提供与声学系统其余部分谐振的超声振动，这使靠近刀具200的声学安装喇叭件124的末端产生最大的前后运动。超声换能器115处20至25微米的移动可通过喇叭件124放大到约40至100微米的刀具移动。
再简略地参见图1，当电力通过操作脚踏开关30或其他开关装置而施加到超声器械110时，控制系统20可(例如)使刀具200以大约55.5kHz的频率纵向振动，并且纵向运动的量将随所施加的(如由使用者可调节地选择的)驱动电力(电流)的量成比例地变化。刀具200可被设计成在施加较高的切割电力时，以超声振动频率在约40至100微米的范围内纵向运动。刀具200的这种超声振动能够在刀具接触组织时产生热量，即穿过组织的刀具200的加速运动将运动刀具200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，这能够减少或消除小血管(如直径小于一毫米的血管)的出血。刀具200的切割效率以及止血程度会随所施加的驱动功率电平、外科医生加于刀具的切割速率或力度、组织类型的性质和组织的血管分布而变化。
再次参见图2，当将电力施加到马达190时，马达190通过小齿轮154将“全部轴向运动”加给齿条构件153而使超声换能器组件114和刀具200相对于中空外套230平移。如本文所用，“全部轴向运动”等用语应与可通过超声换能器组件实现的“超声运动”等区别开。“全部轴向运动”这个用语于是涵盖非唯一地由超声换能器组件114导致的平移运动。
为向超声器械110提供来自超声发生器12的电力(见图1)，可使用多段连接的护套110。如在图2中可见，导体151、152被连接到超声换能器组件114并穿过外壳102伸出器械。另外，护套110可在一端连接到器械外壳102并在另一端连接到换能器组件外壳118。导体151、152可穿过在换能器组件外壳中的一个或多个孔。因此，超声发生器12产生的超声信号通过导体151、152被传送到超声换能器115。护套110可防止导体151、152在马达190启动时被器械100的机械部件损坏或夹断。
仍参见图2，多个实施例还包括远侧突鼻件160，该突鼻件通过紧固件和/或粘接剂(未示出)可拆卸地附接于外壳102的远端。突鼻件160可由(例如)不锈钢、铝或塑料制成。在多种实施例中，刀具200的远端202延伸通过突鼻件160的中空部分210。中空外套230可同样地延伸通过中空部分210。中空部分210可包括环形槽，其中近侧密封件212可抵靠着中空外套230的末端并抵靠着刀具200固定。密封件212可包括(例如)硅树脂O形环、钎焊或压配合密封件并用于在突鼻件160、刀具200和中空外套230之间建立充分的液密和/或气密密封。
同样在多种实施例中，中空外套230可与刀具200同轴对齐并通过(例如)焊接、压配合、螺纹啮合和用胶水或其他粘接剂粘附等连接到突鼻件160的中空部分210。如在图2中可见，抽吸口240可被连接到突鼻件160以与中空外套230中的近侧孔232连通。柔性管242可连接到抽吸口240并与连接到一般地示为244的抽吸源的收集容器243连通。因而，中空外套230形成围绕刀具200而延伸的抽吸通道，其始于外部外套230的远侧部250(例如在开口231处)并通过孔232穿出而到达抽吸口240。本领域的普通技术人员一般都知道还可以有其他可供选择的抽吸通道。另外，类似于近侧密封件212，远侧密封件213可被固定在突鼻件160中并有助于进一步密封其中的中空外套230，使得从开口231通过外套230伸出孔232并通过抽吸口240的抽吸通道被维持成没有或仅有最少的空气从所述通道外部进入。
外科系统10(参见图1)的多种实施例提供了选择性地将超声轴向运动施加到刀具200以及将全部轴向运动施加到刀具200的能力。如果需要，临床医生可在不启动马达190的情况下仅启动超声换能器组件114。在此类情况下，器械100可仅作为超声器械以超声方式使用。纵向超声运动的频率范围可为约(例如)30-80kHz。同样地，临床医生会需要在不启动超声换能器组件114的情况下启动马达190。因而，全部轴向运动将以平移模式施加给刀具200而不对其施加纵向超声运动。显著轴向速度可为(例如)约0.25英寸/秒至5英寸/秒。在其他应用中，临床医生会需要同时以超声方式和平移方式使用器械100，其中刀具200将经历来自换能器组件114的纵向超声运动和来自马达190的全部轴向运动。另外，通过将马达的输出反转，刀具200可在中空外套230内前后平移。举例来说，马达190可首先使刀具200在远侧方向DD上移动。编码器194然后可感测到或计算出刀具200到达中空外套230远端的时间，接着提供反馈以使马达190倒转，从而在近侧方向PD上移动刀具200直到编码器194再次感测或计算出刀具200已在近侧方向PD上充分移动，然后编码器194可再次提供反馈以使马达再次倒转。从而可实现多种这样的显著平移振动或往复运动。此外，本领域的普通技术人员一般不难认识到可结合关节镜以及其他外科应用有效地使用外科系统10的多种实施例。
外科器械100可具有多种远侧部250。图3和图4示出了外科器械的另一个非限制性实施例的远侧部450的例子，其中先前用以描述上文公开的多种实施例的相同标号用来标出相同的部件。在这些实施例中，外科器械包括中空外套430、至少部分设置在中空外套430内的刀具200、可操作地连接到刀具的超声换能器(未示出，参见图2中的换能器115)以及驱动系统(也未示出，参见图2中的马达190)，该驱动系统与换能器连通以将轴向运动传递给刀具200，使得当驱动系统被启动时刀具200(例如)分别在近侧和远侧方向(PD和DD)上相对于中空外套430平移。在此类实施例中，刀具200可具有管状外形，并且在组织通过经由中空外套430的开口431的抽吸而被吸入和/或穿过时可切割组织。因此，可通过启动超声换能器以产生刀具200的超声运动和/或通过启动马达以使刀具200相对于中空外套430以全部轴向运动平移，对抽吸进外套430的组织进行切割。可通过将刀具200的远端202成形为具有锋利刃口或扇贝形状以增强切割。后一形状可有助于切割坚韧的组织。
图5-6B示出了外科器械的另一个非限制性实施例的远侧部550的另一个例子，其中先前用以描述上文公开的多种实施例的相同标号用来标出相同部件。图5是沿中空外套530的纵向轴线截取的剖视图以及图6A和图6B是沿图5中它们各自的剖切线截取的剖视图。在这些实施例中，隔板260可将中空外套530的内部分隔成抽吸部分“A”和刀具部分“B”。抽吸部分A可与抽吸口(未示出，参见上述开口240)连通。另外，隔板260可被分为打孔部分261和无孔部分262，这两部分可与中空外套530形成为一体。作为另外一种选择，隔板260的所有部分均可被打孔。在任何情况下，可对器械进行抽吸，使得在外科手术期间可通过打孔部分261将组织拉向抽吸部分A。此类构造可有助于适当地定位穿过开口531的组织，使得刀具200′可移入并切过被保持在位的组织。另外，参见图5，靠垫226可被固定于外套530和/或隔板260上以提供切割表面，当刀具200′移动至与组织接触时，刀具200′可抵靠着该切割表面切割组织。另外如图6B中可见，刀具200′可包括U形部分以减少质量。
仍参见图5-6B，在至少一个实施例中，可如下切割组织。首先，将负压加到中空外套530的抽吸部分A使得组织被抽吸进开口531。第二，超声换能器可使得刀具200′超声振动。第三，刀具200′可在远侧方向DD上推进使得刀具200′通过全部轴向运动和超声振动这两种运动切割组织。第三，可在保持负压的同时将刀具200′缩回，从而捕获和/或抽吸被切下的组织进入中空外套530的抽吸部分A。
图7A-8示出了外科器械的另一个非限制性实施例的远侧部650的另一个例子，其中先前用以描述上文公开的多种实施例的相同标号用来标出相同部件。图7A和7B为器械远侧部650的纵向剖视图，其中刀具200″在图7A中处于第一位置以及在图7B中处于第二位置。图8是示出中空外套630中的泪滴状开口631的远侧部650的俯视图。在这些实施例中，刀具200″还可包括内腔205，也可通过该内腔施加负压。因此，刀具200″可包括远侧孔206和近侧孔207(参见图2)。如图2中最清楚地看出，近侧孔207可设置在突鼻件160内(参见图2)。在任何情况下，再参见图7A-7B，可通过内腔205施加负压，使得当刀具200″处于第一轴向位置时，组织“T”可通过远侧孔206被抽吸进刀具200″中，参见图7A。当组织被抽吸进刀具200″中后(参见图7A)，可通过将刀具200″在近侧方向平移至第二轴向位置而将组织T夹在远侧孔206和开口631的狭窄部分632之间，参见图7B。其后，可通过启动超声换能器切割组织，如上所述。所述开口的狭窄部分632，加之将组织夹持于其中，可有助于通过刀具200″的超声振动更容易地切断组织。
图9-12C示出了外科器械的另一个非限制性实施例的远侧部750的另一个例子，其中先前用以描述上文公开的多种实施例的相同标号用来标出相同部件。在这些实施例中，中空外套730还可包括倾斜的剪切表面735，靠着该表面刀具200″′可在开口731处切割组织。倾斜的剪切表面735与单个齿类似，类似之处在于其提供锋利刃口，组织可对着该刃口被切割。图9为外科器械的远侧部750的透视图。图10A为中空外套的远侧部的透视图，图10B为刀具200″′的远侧部的透视图，图10C为剪切板736的透视图。剪切表面735可与外套730形成为一体或附装于其上。在至少一个实施例中，剪切表面735可由剪切板736的一部分形成。在此类实施例中，剪切板可通过压销、环氧树脂、按扣结构等在中空外套200″′上固定就位。如在图10A中所见，中空外套730可包括凹进部737和从其伸出的凸起738以接纳剪切板736。另外，图11给出的剖视图中清晰可见，刀具200″′还可包括与倾斜剪切表面735互补的锋利面209。另外，靠近锋利面209，在刀具200″′和中空外套730的内表面之间存在有足够的空隙“C”，使得抽吸负压可从抽吸口(未示出，参见图2中的开口240)连通到开口731。另外，在刀具200″′和外套730之间的空隙C可足够大以使组织能够通过中空外套730被抽吸。
另外，如上所述，刀具200″′可轴向地移过开口731。例如，图12A-12C为外科器械远侧部750的一系列侧剖视图，其中示出刀具200″′相对于中空外套730平移时刀具200″′位于不同的轴向位置。图12A示出了位于最远侧轴向位置的刀具200″′，图12B示出了位于中间位置的刀具200″′，图12C示出了位于近侧位置的刀具200″′。在至少一个实施例中，所述器械可如下工作。首先，当刀具轴向地移过开口731时，刀具200″′可接纳来自一个或多个超声换能器(参见图2中的换能器115)的超声运动，如上所述。另外，在刀具移动前或移动时，负压可被施加于中空外套730。当两个剪切表面735、209彼此接近时，它们可切割悬挂在开口731中的组织原纤。然后被切断的组织片段可通过刀具200″′与中空外套730之间的间隙空间C移动并最后通过上述抽吸口从器械排出。
再简略参见图2，虽然上述驱动系统使用齿条-小齿轮装置作为所述器械的转动-直线移动转换器150，但是也可使用其他转换器。例如，现在参见图13，转换器150′可包括被构造成可将电动马达190′产生的旋转驱动转换成线性运动的滑块-曲柄机构。在此类实施例中，转换器150′可包括连接于第一曲柄构件154′的滑动构件153′，该第一曲柄构件继而连接于与马达轴相连的第二曲柄构件155′。当马达使第二曲柄构件155′沿顺时针“CW”或逆时针“CCW”方向转动时，第一曲柄构件154′使得滑动构件153′分别在近侧或远侧方向(PD或DD)上滑动。如上所述，可连接于超声换能器组件(参见图2中的组件114)的滑动构件153′因此可实现换能器组件以及刀具的全部轴向运动。注意，在本例和转动-直线移动转换器的下述的其他例中，为清楚起见省略了外科器械的多个部件例如外壳。另外，刀具可相对于中空外套显著地往复运动，因为当马达190′使第二曲柄构件155′转动时，滑动构件153′可向近侧然后向远侧移动。
作为另一例，转动-直线移动转换器150″可包括蜗轮。参见图14，示出了马达190″，其轴155″朝换能器组件114伸出。连接于轴155″的可以是与螺纹构件153″螺合的蜗轮154″。螺纹构件153″随后联接于换能器组件114。因此，启动马达190″可使蜗轮154″绕其轴线转动，从而驱动螺纹构件153″，并因此最后分别在近侧或远侧方向(PD或DD)上驱动换能器组件114和刀具(未示出)。
另一个示例性转动-直线移动转换器150″′可包括丝杆。参见图14，示出了马达190″′，而丝杆155″′用作它的轴。丝杆155″′可与连接到支撑构件153″′的螺母154″′螺合。因此，启动马达190″′可使丝杆155″′绕其轴线相对于螺母154″转动，因而驱动螺母154″′、支撑构件153″′、换能器组件114(以虚线显示)，并最后分别在近侧或远侧方向(PD或DD)上驱动刀具。
另外，虽然上述驱动系统使用了马达，但是也可使用手动驱动系统。例如，参见图16，示出了外科器械100′的非限制性实施例的另一个例子，其中先前用以描述上文公开的多种实施例的相同标号用来标出相同部件。在这些实施例中，扳机191可通过枢轴销192枢转地连接于外壳102。所述扳机还可包括在其中接纳换能器组件114的凸起193的槽195。因此，在第一旋转方向RD′上移动扳机191可使得换能器组件114和刀具200在远侧方向DD上移动。在第二旋转方向RD″上移动扳机也可使得换能器组件114和刀具200在近侧方向PD上移动。在使用中，使用者可握住外壳102并用他或她的拇指或其他手指扣动扳机191。
在多种实施例中，可使用器械远侧部(例如远侧部250，参见图2)的其他开口构造。现在将关注点转向一个非限制性实施例，图17-18示出了外科器械的另一个非限制性实施例的远侧部850的另一个例子，其中先前用以描述上文公开的多种实施例的相同标号用来标出相同部件。图17是在中空外套830中包括多个开口831的远侧部850的透视图。组织“T”被示出正在通过与中空外套830连通的抽吸口(未示出，参见图2中的口240)被抽吸或抽吸进开口831中。图18为外科器械远侧部850的局部剖切视图。在这些实施例中，多个开口831可优于一个单独开口，在使组织T稳定的同时将纤维组织T拉过开口并与刀具800接触以供刀具800切割。开口831可在中空外套830中形成为穿孔或孔网。作为另外一种选择，参见图19，开口831′可形成为远侧部850′的外套830′中的狭缝。
另外，在至少一个实施例中，刀具800可仅接纳超声轴向运动，如上所述。因此，也如上所述，可无需驱动系统(包括，例如马达和/或扳机)。然而，参见图18，在可供选择的实施例中，刀具800可接纳全部轴向运动并可操作地连接于驱动系统以使刀具分别在近侧或远侧方向(PD或DD)上移动。
另外，锉刀或带齿刀具可进一步提高器械的切割能力。例如，参见图18，刀具800可包括朝开口831突出并相对于其设置的齿801，使得齿可接触被抽吸进开口831中的组织。齿还可具有变化的外形。现在参见图20A-21C，示出了多种刀齿外形801′、801″、801″′、801″″、801″″′。上述齿外形可为刀具(诸如刀具800、800′和/或800″)提供有利的切割能力。
虽然上述一些实施例包括一个抽吸口，但是在各种实施例中也可使用其他抽吸构造。现在将关注点转向一个非限制性实施例，图22-23示出了外科器械100″的另一个例子，其中先前用以描述上文公开的多种实施例的相同标号用来标出相同部件。图22是使用两个抽吸内腔和两个抽吸口的外科器械100″的一部分的局部剖视图，图23是外科器械100″的远侧部950的透视图。参见图22，外科器械除了其他以外可包括容纳连接到喇叭件124的换能器组件114的外壳102。如上所讨论，喇叭件可以被续接于刀具900。另外，突鼻件160′可包括可通过柔性管242、242′连接到独立的收集容器243、243′和/或真空源244、244′的第一抽吸口240和第二抽吸口241。中空外套930还可包括将中空外套的内部分成第一内腔963和第二内腔964的隔板960。隔板960可延伸到中空外套的近端并紧靠近侧密封件212。第一抽吸口240可与第一内腔963连通并且第二抽吸口241可与第二内腔964连通。参见图23，可看见第一内腔963和第二内腔964分别延伸到中空外套的开口931。因此，对抽吸口240、241(见图22)施加抽吸负压可形成两个抽吸通道(通过第一内腔963和第二内腔964)，这两个通道与开口931连通以将负压加于其上。通过将不同的负压量加到第一抽吸口240和第二抽吸口241，可进一步改变在开口931处的抽吸动力。
刀具900可至少部分地设置在第一抽吸内腔963内。另外，刀具900的远端902可延伸越过开口931。另外，可将抽吸管965加到第二内腔964以提高施加在开口931处或其附近的抽吸力。在任何情况下，对一个或两个抽吸口240、241施加抽吸负压时，组织可向第一内腔963和/或第二内腔964抽吸。双抽吸内腔963、964可在液体环境(例如在关节镜手术期间经历的环境)下提供增强的组织接触和抽吸。两个内腔963、964可提供能够将纤维组织拉入并从中排出碎片的可靠装置。
参见图24A，其示出了刀具900的远侧部的侧视图，刀具900可以是锉刀或包括靠近其远端902处的一些齿901。通过增加优化的表面以在液体环境中发生摩擦，齿901可有助于改善组织消融。另外，刀具900可连接到超声换能器，例如容纳在超声换能器组件114(参见图22)中的一个或多个超声换能器，使得刀具900可经历超声振动，同时如上所述刀具900也可连接到被构造为向其施加全部轴向运动的驱动系统，从而增强刀具900的切割能力。另外，在至少一个实施例中(参见图23)，刀具的远端902可通过驱动系统缩回至中空外套930中，使得刀具不意外地切割组织直到需要刀具切割时，届时刀具可通过开口931再伸出。
作为另外一种选择，可使用其他刀具构造。例如，参见图24B，刀具900′可含有靠近其远端902′的平坦表面901′。在此类实施例中，该表面自身可在向其施加超声振动时产生足够大的摩擦力以切割组织。
虽然上述实施例中的一些已公开了刀具的全部轴向运动以提供多种优点，但是也可通过代之以利用刀具的显著旋转运动的外科器械来获得类似的优点。现在将关注点转向一个非限制性实施例，图25-26示出了另一个外科器械300，其中先前用以描述上文公开的多种实施例的相同标号用来标出相同部件。在这些实施例中，外科器械300包括装有连接到超声喇叭324的换能器组件314的外壳302。超声喇叭324可连接到刀具200的近端，如上所讨论。超声喇叭324可通过远侧轴承336可旋转地支承于外壳302内。突鼻件160可按上述方式通过紧固件161连接到外壳302。
在此实施例中，可提供与换能器组件314连通以向其递送旋转运动的驱动系统，使得当驱动系统被启动时刀具相对于中空外套230旋转。例如，超声换能器组件314可具有嵌装的或以其他方式附装于其上的磁体316以形成一体式马达转子，一般地标示为320。马达定子环330安装在外壳302内，如图所示。导体332、334连接到马达定子环330并穿过共用的外套76以连接到如上所述的控制系统20中的马达电缆33。中空轴340延伸通过马达转子320以形成导体151、152的通道。导体151、152连接到超声换能器组件314和内接触环2154。内接触环2154连接到可旋转地延伸进滑环组件2150的中空轴340的一部分上，该滑环组件也被支承在外壳302内。中空轴340通过近侧轴承342可旋转地支承于外壳302内。滑环组件2150固定(即，不可转动)在外壳302内，并包括连接到构成发生器电缆14的导体2157、2158的固定外触头2156。马达定子330被供电时，使转子320和一体式超声换能器314绕轴线A-A转动。来自超声发生器12的超声信号借助于内接触环2154与外触头2156之间的旋转接触或电连通被传输至内接触环2154。这些信号通过导体151、152传输至超声换能器组件314。可通过抽吸口240在刀具200与中空外套230之间施加负压。收集容器243和抽吸源240可通过管242连接到抽吸口240。刀具的远端在器械的远侧部250通过中空外套230远端中的窗口露出以使刀具暴露于组织，这将在下文中进一步讨论。
关于外科器械300的补充细节以及具有旋转刀具的外科器械的其他实施例可见于与本申请同一日期提交的题为“ULTRASONIC SURGICALINSTRUMENTS WITH ROTATING CUTTING IMPLEMENT”(具有旋转切割工具的超声外科器械)的美国专利申请No.________(代理人案卷号END6688USNP/090341)，该专利以引用方式全部并入本文。
在至少一个实施例中，外科器械的远侧部可被构造为夹持正被切割的组织。现在将关注点转向一个非限制性实施例，图27示出了外科器械的远侧部1050的例子，其中先前用以描述上文公开的多种实施例的相同标号用来标出相同部件。中空外套1030可包括设置在其中的开口1031，使得组织可被抽吸进该开口并与刀具1000接触。开口1031还可包括被构造成可咬住位于开口1031内的组织的一个或多个齿1032。另外，开口1031可离开刀具1000而突出，或以其他方式被成形为增加开口的表面积以在向器械施加负压时增加开口1031处的抽吸力，如上所述。因而，当刀具1000被超声致动和/或被显著地平移或转动时，图示为正被朝向开口1031抽吸的组织“T”可被器械更好地固定。在刀具切割时固定或夹持组织T，可有利于防止组织T绕过刀具1000的刀刃1006。
所述齿1032可为如图27中所示的环状肋。作为另外一种选择，参见示出了多种齿的可选方案的图28-29，齿1032可为钩1032′、鱼鳞状扣袢1032″或粗糙表面(未示出)。图29示出了正被扣袢1032″咬住的组织T。
再有，如上指出，刀具可通过上述的驱动系统相对于中空轴显著地地转动或平移。另外，在至少一个实施例中，刀具1000可以是中空的并在其中限定内腔1005，通过该内腔可施加负压以将组织朝刀具抽吸并使之与刀具接触。在至少一个实施例中，抽吸口240(参见图25-26)可只与内腔1005连通。换句话讲，可将抽吸通道限制为内腔1005并且不包括中空外套1030与刀具1000之间的空间。详见图30，其示出了突鼻件160和多种相关部件的实施例，中空外套1030被支承于其中具有抽吸口240的中空突鼻件160内。柔性管242可连接到抽吸口240并与连接到一般地示为244的抽吸源的收集容器243连通。中空外套1030可通过近侧密封件1013和远侧密封件1015支承于突鼻件160内，所述近侧密封件和远侧密封件位于抽吸口240的两侧并用于在其间建立液密密封。中空外套1030设置有与近侧密封件1013和远侧密封件1015之间的抽吸口240配准的至少一个近侧开口1014。另外，刀具1000可至少通过近侧刀具密封件1025和远侧刀具密封件1027可旋转地支承于中空外套1030内。至少一个刀具排放口1028可通过刀具1000的内腔1005设置在近侧刀具密封件1025和远侧刀具密封件1027之间以排放进至少一个近侧外套开口1014中。
在多种实施例中，在旋转式外科器械(如上述外科器械300)中，可能需要减小刀具的质量来优化旋转切割速度。因而，在至少一个非限制性实施例中，现在注意看图31-32，刀具1100的形状可以为桨叶形。图31是包括可旋转刀具1100的外科器械的远侧部1150的侧视图，图32是沿线32-32截取的远侧部1150的剖视图。中空外套1130可包括开口1131，如上所讨论。刀具1100可至少部分地设置在中空外套1130内并包括宽阔部分1101和狭窄部分1102。狭窄部分1102可向近侧延伸并连接到喇叭件324(参见图25)。刀具1100的宽阔部分1102可朝开口1131延伸和/或进入开口。
在至少一个实施例中，参见图32，刀具1100可包括一个或多个凹面1103以在刀具1100沿顺时针“CW”或逆时针“CCW”方向旋转时进一步减小转动惯性。另外，凹面1103可沿着刀具1100的横截面变化以增强刀具的切割能力。现在参见图33A和33B，可看见分别沿线33A-33A和33B-33B截取的刀具1100的剖视图。凹面1103的远侧部(参见图33A)可厚于和高于凹面的近侧部(参见图33B)。作为另外一种选择，参见图34，可通过沿着刀具1100′的纵向轴线形成孔1105而减小刀具1100′的质量。在至少一个实施例中，孔1105可被磨削成刀具1100′。
在至少一个实施例中，参见图35-36，可与上述中空外套1130一起使用的刀具1200的质量可通过使用包括间隙1206的刀具得以减小，间隙的设置方式使得其可在外套1130的开口1131内对齐，参见图31。再次参见图35，刀具1200可包括狭窄部分1202和宽阔部分1201。宽阔部分1201可进一步在其中限定间隙1206，间隙的设置方式可使得当将刀具1200与外套1130一起使用时，间隙1206与开口1131邻近或吻合，参见图31。宽阔部分1201的长度“D”可使得长度D至少与开口1131的长度一样，参见图31。如上所述并再次参见图36，刀具1200的宽阔部分1201可包括凹面1203以减小刀具质量。作为另外一种选择，通过包括被质量平衡成使其具有偏离旋转轴线的椭圆中心的刀具，刀具的质量可进一步减小。例如，图37的外科器械的远侧部1350的轴向或前剖视图包括示出为设置在中空外套1130内的刀具1300，如上所述。刀具1300可被构造为绕轴线“A”旋转。然而，凹面1303可不关于该轴线对称。例如，刀具1300的第一侧面1307可宽于第二侧面1308。在此类实施例中，椭圆中心“B”可偏离旋转轴线A。因此，刀具可由非均质材料制成，使得关于旋转轴线A的质量分布得以平衡并且刀具可高速旋转而不损坏自身或中空外套1130。
可以有替代的旋转刀具构造。例如，参见图38-39，提供了非限制性实施例，其中刀具1400可包括靠近中空外套730中的开口731设置的螺旋面1403。外套730可类似于图9中所见并如上文所讨论的外套730。例如，外套730还可包括具有设置在开口731中的倾斜剪切表面735的剪切板736，如上所讨论。同样如上指出，倾斜剪切表面735可类似于单个齿，类似之处在于其提供锋利刃口，靠着该刃口组织可被切割。在任何情况下，螺旋面1403可像螺旋钻一样运行并当刀具1400旋转时，螺旋面1403可朝剪切板736牵拉组织以增强对组织的切割。
在多种实施例中，可用活动的组织夹持构件来夹持组织，以增强对组织的切割。现在将关注点转向一个非限制性实施例，图40-43示出了另一个外科器械300′，其中先前用以描述上文公开的多种实施例的相同标号用来标出相同部件。图40为外科器械300′的局部剖视图。例如，至少除了还包括具有枢转地连接于突鼻件160的扳机391的驱动系统，而所述扳机又续接于组织夹持构件1550并构造成可使之相对于中空外套1530移动(参见图42A-42B)之外，外科器械300′可类似于如上所述的并如图25所见的外科器械300。另外，如上所述，刀具1500被构造成可至少部分地在中空外套1530内旋转。
如上所述，该驱动系统可被构造成可将轴向运动传递给组织夹持构件1540，使得当驱动系统被启动时组织夹持构件相对于中空外套1530平移。更详细地，现在注意看图42A-42B，图42A是组织夹持构件1540示出在延伸位置的外科器械300′的远侧部1550的透视图，图42B是组织夹持构件1540示出在缩回位置的远侧部1550的透视图。中空外套1530可包括朝远侧方向DD开口的远侧开口1531。另外，组织夹持构件1540可从开口1531伸出。至少一根和任选地两根承载缆线1551、1552可连接到组织夹持构件1540并从其向近侧方向PD延伸。如本文所用，缆线可包括实芯缆线、绞合缆线、链、带、绳等以及任何其他承载构件。参见图43，其示出了沿图42A中的线43-43截取的中空外套1530、缆线1551、1552和刀具1500的剖视图，在中空外套1530内可为尺寸和构造适于在其中接纳缆线1535、1536的通道1535、1536。所述通道可在位于或靠近外套开口1531的远侧开口(未示出)处敞开，但未作图示。仍参见图43，刀具1500可包括如上讨论的凹面1503以有助于切割组织；或者刀具还可包括也如上所述的螺旋面。再参见图40和图41，图41示出了沿位于或靠近外套1550近端的线41-41截取的中空外套1550、缆线1551、1552以及刀具1500的剖视图。如在图41中可见，在突鼻件160内，缆线1551、1552可通过限定在中空外套1530中的孔1537、1538穿过中空外套的通道1535、1536。所述缆线可连接在枢转地安装于突鼻件的扳机391上。因此，使用者移动扳机391可使缆线1551、1552并且随后使组织夹持构件1540相对于中空外套1530轴向移动或平移。
外科器械300′可按如下方式使用。首先，使用者可操控扳机391以延伸组织夹持构件1540，如在图42中所见。接下来，使用者可将组织置于中空外套1530和夹持构件1540之间。任选地，可向抽吸口240施加负压以有助于定位组织。然后，使用者可移动扳机391使得夹持构件1540缩回到如图42B所示的位置，从而将组织牵拉到中空外套1530中并与刀具1500接触。与此同时或缩回夹持构件1540之后，使用者可启动超声换能器组件314以将超声振动加到刀具1500上。任选地，也可给马达定子330供电，以使转子320、一体式超声换能器314和刀具1500绕轴线A-A旋转。因此，可通过刀具1500的超声振动和显著旋转运动中的一者或两者切割被夹持的组织。在切割组织后，残留物可通过抽吸口240被抽吸到器械300′之外，如上所述。可重复上述示例性步骤来切割更多组织。
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团队组装。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多种实施例。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，将器械置于封闭并密封的容器中，例如塑料或TYVEK
Figure BPA00001596274600261
口袋中。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。
在多种实施例中，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。
以引证方式全部或部分地并入本申请的任何专利、公布、或其他公开材料仅在所并入的材料不与本发明所述的现有定义、陈述、或其他公开材料相冲突的范围内并入本申请。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)

1.一种外科器械，包括：
中空外套；
至少部分地设置在所述中空外套内的刀具；
可操作地连接到所述刀具的至少一个超声换能器；以及
驱动系统，所述驱动系统与所述至少一个换能器连通以将全部轴向运动传递给所述刀具，使得当所述驱动系统被启动时所述刀具相对于所述中空外套平移。
2.根据权利要求1所述的外科器械，还包括：
在所述中空外套中的多个开口；
在所述刀具上的至少一个齿；以及
与所述中空外套连通的抽吸口，其中所述抽吸口被构造成便于将负压加到所述多个开口使得组织被抽吸进所述多个开口中。
3.根据权利要求1所述的外科器械，其中所述中空外套包括在其中的至少一个开口、第一抽吸内腔和第二抽吸内腔，其中所述第一抽吸内腔和所述第二抽吸内腔与所述至少一个开口连通以对其施加负压，并且其中所述外科器械还包括：
至少部分地设置在所述第一抽吸内腔内的刀具。
4.根据权利要求3所述的外科器械，还包括与所述第一抽吸内腔连通的第一抽吸口和与所述第二抽吸内腔连通的第二抽吸口。
5.根据权利要求3所述的外科器械，其中所述刀具延伸通过所述至少一个开口。
6.根据权利要求1所述的外科器械，其中所述中空轴还包括位于其中的隔板，其中所述隔板包括打孔部分。
7.根据权利要求1所述的外科器械，其中所述刀具还包括在其中限定的内腔。
8.根据权利要求1所述的外科器械，其中所述中空外套包括具有倾斜剪切表面的至少一个开口。
9.根据权利要求1所述的外科器械，其中所述驱动系统包括连接到齿条-小齿轮机构、滑块-曲柄机构、涡轮机构和丝杆机构中的一者的马达。
10.根据权利要求1所述的外科器械，其中所述驱动系统包括可操作地与所述至少一个超声换能器接合的扳机。
11.一种外科器械，包括：
中空外套，所述中空外套包括位于其中的至少一个开口和设置在开口中的至少一个齿，其中所述至少一个齿被构造成夹持位于所述至少一个开口中的组织；
至少部分地设置在所述中空外套内的刀具；
连接于所述刀具的至少一个超声换能器；以及
驱动系统，所述驱动系统与所述至少一个换能器连通以将旋转运动传递给所述刀具，使得当所述驱动系统被启动时所述刀具相对于所述中空外套转动。
12.根据权利要求11所述的外科器械，其中所述刀具包括靠近所述至少一个开口设置的凹面。
13.根据权利要求12所述的外科器械，其中所述刀具包括偏离所述刀具的旋转轴线的椭圆中心。
14.根据权利要求11所述的外科器械，其中所述至少一个齿包括倾斜剪切表面。
15.根据权利要求11所述的外科器械，其中所述刀具包括被设置成靠近所述至少一个开口的螺旋面。
16.根据权利要求11所述的外科器械，其中所述刀具还包括在其中限定的内腔。
17.根据权利要求11所述的外科器械，其中所述刀具的形状为桨叶形。
18.一种外科器械，包括：
包括位于其中的至少一个开口的中空外套；
至少部分地设置在所述中空外套内的刀具；
连接于所述刀具的至少一个超声换能器；
由所述中空轴可动地支撑的组织夹持构件；
连接到所述组织夹持构件的驱动系统，其中所述驱动系统被构造成将全部轴向运动传递给所述组织夹持构件，使得当所述驱动系统被启动时所述组织夹持构件相对于所述中空外套平移。
19.根据权利要求18所述的外科器械，其中所述刀具包括凹面。
20.根据权利要求18所述的外科器械，其中至少一根缆线将所述组织夹持构件连接到所述驱动系统。
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US9962182B2 (en) 2018-05-08
US8961547B2 (en) 2015-02-24
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