CN102843982A - 超声动力外科器械的密封构造 - Google Patents
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Abstract
在一个一般方面，本发明提供了多种实施例，其涉及可在含水环境中使用的超声外科器械。所述器械可包括支撑在中空护套内的切割构件。本发明公开了多种密封构造，用于在所述切割构件与所述护套之间形成基本上的流体密封。
Description
背景技术
本发明总体上涉及超声手术系统，更具体而言，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。这些装置通常包括电源、手柄和一次性使用的端部执行器。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，其中通过内管尖端产生的截断动作切割组织，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，以切割通过外部构件孔隙进入的组织。
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以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。针的超声运动将组织破裂成碎片。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，该探针被遮挡以收窄从探针顶端发出的超声能量束。在一个实施例中，该遮挡部分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。
关节镜手术涉及在关节间隙中施行手术。为进行该手术，通常在关节中填充加压的生理盐水以便扩张和可视化。可用在此类手术中的超声器械必须经受住流体压力而无渗漏。然而，常规的超声器械在使用过程中一般会显著地受力。当前的超声装置密封件通常并不足够强固，难以经受这种环境而无渗漏。
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。
还希望提供用于在关节镜手术的含水环境中进行切割和凝固的超声外科器械的更强固的密封构造。
上述讨论仅仅为了说明在本发明的各种实施例所涉及的领域内当前存在的一些不足，而不应看作是对权利要求范围的否定。
发明内容
结合一个一般方面，提供了一种超声外科器械，其包括可操作地支撑超声换能器组件的外壳。刀片可连接到超声换能器组件，而中空护套可连接到外壳并且在刀片的一部分周围轴向延伸。该器械还可包括用于在刀片的一部分与中空护套之间形成密封的密封组件。在多种实施例中，密封组件可包括连接到刀片的第一环形密封部分。两个轴向密封部分自第一环形密封部分在相对的轴向上轴向延伸超过第一环形密封部分。轴向密封部分可以取向为与中空护套内壁的相应部分柔性密封接触。
结合另一个一般方面，提供了一种超声外科器械，其包括可操作地支撑超声换能器组件的外壳。刀片可连接到超声换能器组件并且在其一部分上具有环形密封件。该器械还可包括中空护套，其包括第一护套段和第二护套段，所述第二护套段可连接到第一护套段，以形成用于在其中接纳刀片一部分的大致中空内腔。第一护套段和第二护套段可以相对于彼此构造，以在中空管内形成环形凹槽，用于在将第一护套段和第二护套段连接在一起并且在中空内腔内接纳刀片的一部分时在其中密封接纳环形密封件。
结合又一个一般方面，提供了一种超声外科器械，其包括在其中支撑超声换能器组件的外壳。刀片可连接到超声换能器组件，而中空护套可连接到外壳并且在刀片的一部分周围轴向延伸。该器械还可包括用于在刀片的一部分与中空护套之间形成密封的密封组件。在多种实施例中，密封组件可包括连接到刀片的环形密封件以及从中空护套的内壁突出的邻近环形密封件近端的第一环形环构件。
结合另一个一般方面，提供了一种超声外科器械，其可包括在其中支撑超声换能器组件的外壳。刀片可连接到超声换能器组件。中空护套可连接到外壳并且在刀片的一部分周围轴向延伸。该器械还可包括连接到刀片的一部分的环形密封件。环形密封件可具有大于中空护套内径的外径并且还具有近侧和远侧，使得当所述刀片的一部分安装在中空护套内时，近侧的一部分与中空护套的内壁密封接合。
结合另一个一般方面，提供了一种在超声外科器械的刀片与该器械的中空护套之间形成基本上的流体密封的方法。该方法的多种形式可包括在切割构件上安装密封件，其中密封件在其中具有环形凹槽，以及使中空护套的一部分形成在密封件中的所述环形凹槽内。
附图说明
多个非限制性实施例的特征在所附权利要求书中详细阐述。然而，结合下述附图参阅随后的说明，可最好地理解关于构成和操作方法的多种非限制性实施例，以及它们的目的和优点。
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是控制系统外壳结构的另一个非限制性实施例的透视图；
图2是手柄的非限制性实施例的剖视图；
图3是与多种非限制性实施例一起使用的超声外科手柄的局部剖视图；
图4是非限制性突鼻件实施例的一部分的剖视图；
图5是非限制性突鼻件实施例的局部分解组件视图；
图6是外科器械手柄的非限制性实施例的局部剖视图；
图7是图6的非限制性外科器械手柄实施例的透视图；
图8是另一个非限制性外科器械手柄实施例的局部剖视图；
图9是另一个非限制性外科器械手柄实施例的局部剖视图；
图10是图9中示出的外科器械手柄实施例的透视图；
图11是将马达连接于换能器组件的非限制性连接组件实施例的局部分解组件视图；
图12是非限制性连接组件实施例的薄板件与传动轴构造的侧视图；
图13是图12的非限制性薄板件实施例的端视图；
图14是另一个非限制性连接组件实施例的非限制性薄板件与传动轴构造的侧视图；
图15是图14的非限制性薄板件实施例的端视图；
图16是另一个非限制性外科器械手柄实施例的局部剖视图；
图17是非限制性外部护套和刀片实施例的局部透视图；
图18是图17中示出的非限制性刀片实施例的局部透视图；
图19是图17和18的刀片的局部底部透视图；
图20是另一个非限制性刀片实施例的一部分的侧视图；
图21是另一个非限制性刀片实施例的一部分的侧视图；
图22是另一个非限制性外部护套与刀片构造的远端的局部透视图；
图23是另一个非限制性外部护套与刀片构造的远端的局部透视图；
图23A是图23中示出的非限制性外部护套实施例的一部分的侧视图；
图24是另一个非限制性刀片实施例的一部分的侧视图；
图25是另一个非限制性刀片实施例的一部分的侧视图；
图26是在另一个非限制性外部护套实施例的远端内的图25的非限制性刀片实施例的局部透视图；
图27是另一个非限制性刀片实施例的一部分的侧视图；
图28是在另一个非限制性外部护套实施例的远端内的图27的非限制性刀片实施例的局部透视图；
图29是图28的非限制性刀片和外部护套实施例的横截面端视图；
图30是另一个非限制性刀片实施例的一部分的侧视图；
图31是在另一个非限制性外部护套实施例的远端内的图30的非限制性刀片实施例的局部透视图；
图32A示出了在图31的外部护套实施例内的图30和31的非限制性刀片实施例的第一旋转位置；
图32B示出了在图31的外部护套实施例内的图30和31的非限制性刀片实施例的第二旋转位置；
图32C示出了在图31的外部护套实施例内的图30和31的刀片实施例的第三旋转位置；
图32D示出了在图31的外部护套实施例内的图30和31的刀片实施例的第四旋转位置；
图33是另一个非限制性刀片实施例的一部分的透视图；
图34是在非限制性外部护套实施例内的图33的刀片实施例的局部透视图；
图34A是另一个非限制性刀片和外部护套实施例的局部透视图；
图35是另一个非限制性刀片实施例的一部分的透视图；
图36是另一个非限制性超声外科器械实施例的局部剖视图；
图36A是本发明的另一个非限制性外科器械实施例的突鼻件部分的局部剖视图；
图37是图36的非限制性外部护套的远端和刀片构造的局部透视图；
图38是正在切割组织的图37所示的外部护套和刀片实施例的远侧部分的剖视图；
图39示出了结合执行椎间盘切除术的图36的外科器械实施例的用途；
图40进一步示出了结合执行椎间盘切除术的图36的外科器械实施例的用途；
图41是其上安装有可选择性缩回的安全护套的图36的外科器械实施例的侧正视图；
图42是开始从关闭位置缩回的图41中示出的可缩回安全护套实施例的局部透视图；
图43是安全护套缩回至打开位置的图41和42中示出的可缩回安全护套实施例的另一个局部透视图；
图44是安全护套缩回至打开位置的图41-43中示出的可缩回安全护套实施例的另一个局部透视图；
图45是安全护套以横截面示出在打开位置的图41-44中示出的外部护套和安全护套实施例的一部分的侧正视图；
图46是另一个非限制性刀片实施例的一部分的透视图；
图47是另一个非限制性实施例的另一个中空外部护套与刀片构造的一部分的侧视图；
图48是另一个非限制性刀片实施例的剖视图；
图49是另一个非限制性刀片实施例的剖视图；
图50是另一个非限制性刀片实施例的剖视图；
图51是另一个非限制性刀片实施例的剖视图；
图52是另一个非限制性外部护套和刀片实施例的局部剖视图；
图53是与身体组织相互作用的图52的外部护套与刀片构造的另一个局部剖视图；
图54是图52和53中示出的与身体组织相互作用的外部护套与刀片构造的端部剖视图；
图55是另一个非限制性外部护套实施例的局部透视图；
图56是另一个非限制性外部护套实施例的局部透视图；
图57是支承另一个非限制性刀片实施例的图56的外部护套实施例的局部剖视图；
图58是另一个非限制性外部护套实施例的局部透视图；
图59是另一个非限制性外部护套和刀片实施例的剖视图；
图60示出了形成在非限制性外部护套实施例上的切割刃之间的角；
图61是另一个非限制性外部护套实施例的透视图；
图62是图61的外部护套和刀片实施例的剖视图；
图63是另一个非限制性外部护套实施例的透视图；
图64是图63的外部护套和刀片实施例的剖视图；
图65是另一个非限制性外部护套实施例的透视图；
图66是图65的外部护套和刀片实施例的剖视图；
图67是另一个非限制性外部护套与刀片构造的横截面端视图；
图68是图67的外部护套与刀片构造的局部侧剖视图；
图69是图67和68的外部护套与刀片构造的远端部分的局部侧视图；
图70是连接于图67-69的外部护套与刀片构造的非限制性手柄外壳实施例的侧视图；
图71示出了一种使用图70的外科器械实施例的方法；
图72示出了另一种使用图70的外科器械实施例的方法；
图73示出了另一种使用图70的外科器械实施例的方法；
图74是另一个非限制性外科器械实施例的局部侧剖视图；
图75是与图74中示出的外科器械实施例一起使用的外部护套与刀片构造的一部分的透视图；
图76是图75的外部护套与刀片构造的端视图；
图77是图75和76的护套和刀片构造的横截面端视图；
图78是另一个非限制性超声外科器械实施例的侧视图；
图79是位于中空护套与超声工具实施例的波导部分之间的非限制性密封件实施例的局部剖视图；
图80是位于中空护套与超声工具实施例的波导部分之间的另一个非限制性密封件实施例的局部剖视图；
图81是位于中空护套与超声工具实施例的波导部分之间的另一个非限制性密封件实施例的局部剖视图；
图82是位于中空护套与超声工具实施例的波导部分之间的另一个非限制性密封件实施例的局部剖视图；
图83是在褶皱就位之前位于中空护套与超声工具实施例的波导部分之间的另一个非限制性密封件实施例的局部剖视图；
图84是在褶皱就位之后图83的密封件实施例的局部剖视图；
图85是位于两件式中空护套与超声工具实施例的波导部分之间的另一个非限制性密封件实施例的局部剖视图；
图86是位于另一个两件式中空护套与超声工具实施例的波导部分之间的另一个非限制性密封件实施例的局部剖面分解组件视图；
图87是图86的两件式中空护套实施例的一部分的局部透视图；
图88是位于中空护套与超声工具实施例的波导部分之间的另一个非限制性密封件实施例的局部剖视图；
图89是位于中空护套与超声工具实施例的波导部分之间的另一个非限制性密封件实施例的局部剖视图；
图90是位于中空护套与超声工具实施例的波导部分之间的另一个非限制性密封件实施例的局部剖视图；
图91A是示出了准备切割坚韧组织的两个切割刃实施例的初始位置的图例；
图91B是图91A的切割刃和组织的第二位置；
图91C是图91A-B的切割刃和组织的第三位置；
图91D是图91A-C的切割刃和组织的第四位置；
图92是非限制性切割刀片和套管实施例的一部分的透视图；
图92A是安装在非限制性外科器械实施例的内部护套中的图92的刀片和套管实施例的一部分的局部剖视图；
图93是在非限制性外科器械实施例中的图92的刀片和套管实施例的一部分的剖视图；
图94是另一个非限制性切割刀片和套管实施例的一部分的透视图；
图95是在非限制性外科器械实施例中的图94的刀片和套管实施例的一部分的剖视图；
图96是非限制性刀片和外部护套实施例的一部分的局部透视图；
图97是图96的刀片和外部护套构造的剖视图；
图98是图97的外部护套与刀片构造的一部分的局部后部透视图；
图99是另一个非限制性外部护套与刀片构造的一部分的局部后部透视图；
图100是另一个非限制性外部护套实施例的局部透视图；
图101是支承其中的切割刀片实施例的图100的外部护套实施例的横截面端视图；以及
图102是另一个非限制性刀片实施例的一部分的透视图。
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，这些专利申请各自的全部内容均以引用方式并入本文：
标题为“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.___________；
标题为“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.________；
标题为“ULTRASONIC SURGICAL INSTRUMENTS WITHROTATABLE BLADE AND HOLLOW SHEATH ARRANGEMENTS”(具有可旋转刀片和中空护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._____________；
标题为“ROTATABLE CUTTING IMPLEMENTARRANGEMENTS FOR 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._________；
标题为“ULTRASONIC SURGICAL INSTRUMENTS WITHPARTIALLY ROTATING BLADE AND FIXED PADARRANGEMENT”(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.________；
标题为“DUAL PURPOSE SURGICAL INSTRUMENT FORCUTTING AND 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.________；
标题为“OUTER SHEATH AND BLADE ARRANGEMENTS FORULTRASONIC SURGICAL INSTRUMENTS”(超声外科器械的外部护套与刀片构造)、代理人案卷号为END6695USNP/090348的美国专利申请No.__________；
标题为“ULTRASONIC SURGICAL INSTRUMENTS WITHMOVING CUTTING IMPLEMENT”(具有移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._________；以及
标题为“ULTRASONIC SURGICAL INSTRUMENT WITH COMB-LIKE TISSUE 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.__________。
多种实施例涉及用于处理组织的设备、系统和方法。对许多特定细节作了阐述，以使读者对说明书中所述和附图中所示的实施例的整体结构、功能、制造和用途有透彻理解。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本实施例。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“多种实施例”、“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“在多种实施例中”、“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他实施例的特征、结构或特性结合。
多种实施例涉及能够用于在外科手术期间施行组织解剖、切割和/或凝固的经改良的超声手术系统和器械，以及因而所采用的切割工具和密封结构。在一个实施例中，超声外科器械设备能够用于开放性手术中，但所述设备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)中。超声能量的选择性使用和切割/凝固工具的选择性旋转，有助于多方面用途的实现。
应当理解，本文使用的术语“近侧”和“远侧”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侧。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。
手术系统
图1以示意方式图解手术系统10的一个非限制性实施例。手术系统10可包括超声发生器12和超声外科器械组件100，后者可包括“独立”超声器械110。如下文将进一步详细讨论，超声发生器12可由电缆14通过位于外科器械组件100的外壳部分102中的滑环组件150连接于独立超声器械110的超声换能器组件114。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连接于控制模块24的电源22，以向其提供例如24V直流电。马达控制模块24可包括由德克萨斯州奥斯汀美国国家仪器公司(National Instruments ofAustin，Texas)制造的型号为NI cRIO-9073的控制模块。然而，也可使用其他马达控制模块。电源22可包括由美国国家仪器公司(NationalInstruments)制造的电源。然而，其他电源也可成功使用。电源22可由电缆25另外连接于马达驱动器26，也向其提供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。控制模块24也可由电缆27连接于马达驱动器26以向其供电。常规的脚踏开关30或其他控制开关装置可由电缆31连接于控制模块24。如在下文中将进一步详细地讨论，超声外科器械100可包括其上结合有编码器194的马达190。马达190可包括由美国国家仪器公司(National Instruments)制造的型号为CTP12ELF10MAA00的马达。编码器194可包括由华盛顿州温哥华市美国数码公司(U.S.Digital ofVancouver，Washington)制造的型号为E2-500-197-I-D-D-B的编码器。然而，也可使用其他马达和编码器。编码器194可通过编码器电缆32连接于马达控制模块24并且马达190可通过电缆33连接于马达驱动器26。手术系统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。
也可在图1中看到，在多种实施例中，马达控制系统20装于外壳21中。为促进便携性，各种部件可通过可拆卸的电缆连接器连接于马达控制系统20。例如，脚踏开关30可通过电缆35连接于可拆卸电缆连接器37，以便于将脚踏开关快速地连接于控制系统20。交流市电可通过普通的带插头电缆50提供给电源22，该带插头电缆附接于与电缆52连接的可拆卸电缆连接器54。计算机40可具有附接于与电缆42连接的可拆卸电缆连接器62的电缆60。编码器194可具有附接于可拆卸连接器72的编码器电缆70。同样地，马达190可具有附接于可拆卸连接器72的电缆74。可拆卸连接器72可通过电缆32连接于控制模块24并且连接器72可通过电缆33连接于马达驱动器26。因而，电缆连接器72用于将编码器194连接于控制模块24并将马达190连接于马达驱动器26。电缆70和74可容纳在共同的护套76中。
在可供选择的实施例中，超声发生器12和控制系统20可容纳在同一外壳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与马达控制系统20电气连通。这样的布置可共享数据链路并共用供电装置(电线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12一体地形成，或可作为电连接于超声发生器12的单独的电路模块而提供(用虚线示出以示出此可选方式)。在一个实施例中，信号发生器模块15可与超声发生器模块13一体地形成。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。仍结合图1，电缆14可包括多个导线以将电加到超声换能器组件114的正(+)和负(-)电极上，如将在下文中进一步详细地讨论。
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日提交的标题为“RotatingTransducer Mount 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(“Methodfor Improving the Start Up of an Ultrasonic System Under Zero LoadConditions”(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 a Loose Blade in a HandleConnected to an Ultrasonic Surgical System”(检测连接于超声手术系统的柄部中刀片松动的方法))；美国专利No.6,626,926(“Method forDriving an Ultrasonic System to Improve Acquisition of Blade ResonanceFrequency at Startup”(用以改进启动时刀片谐振频率获取的超声系统驱动方法))；美国专利No.6,633,234(“Method for Detecting BladeBreakage Using Rate and/or Impedance 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(“Methodfor Detecting Presence of a Blade in an Ultrasonic System”(检测超声系统中刀片存在的方法))；美国专利No.6,678,621(“OutputDisplacement Control Using Phase Margin in an Ultrasonic SurgicalHandle”(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 for Detecting Transverse Vibrations in anUltrasonic 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 for Altering Generator Functionsin an Ultrasonic Surgical System”(用于改变超声手术系统中发生器功能的装置和方法))；美国专利No.6,977,495(“Detection Circuitryfor 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 Transducer Capacitance toDetermine 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”(用以改进启动时刀片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 forAlerting Generator Function in an Ultrasonic Surgical System”(用于警示超声手术系统中发生器功能的装置和方法))。
外科器械
如在图2中可见，超声外科器械手柄100可包括装有马达190、编码器194、滑环组件150以及独立超声外科器械110的外壳102。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)连在一起，并且可由例如聚碳酸酯材料制成。马达190可包括(例如)由美国国家仪器公司(National Instruments)制造的型号为CTP12ELF10MAA00的步进马达。然而，可使用其他马达以实现(例如)独立超声外科器械110相对于外壳102的约1-6000rpm的“显著”旋转运动。编码器194将马达轴192的机械转动转化成电脉冲，而电脉冲将速度和其他马达控制信息提供给控制模块24。
独立超声外科器械110可包括由爱惜康内镜外科公司(EthiconEndo-Surgery)制造和销售的型号为HP054的外科器械。然而，也可成功地使用其他超声器械。应当理解，文中所用的术语“独立”是指超声外科器械除了与外科器械100一起使用外可有效地单独用作超声外科器械。如在图3中更详细地所示，超声外科器械110包括支承压电超声换能器组件114的外壳112，该压电超声换能器组件将电能转化成机械能以产生换能器组件114的末端的纵向振动。超声换能器组件114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。超声换能器组件114可安装在两个圆柱体116和118之间。另外，圆柱体120可附接于圆柱体118，其又在另一个运动零点122处安装到外壳上。喇叭件124也可在一侧附接于零点处，在另一侧附接于连结器126。刀片200可固定在连结器126上。因此，刀片200将通过超声换能器组件114以超声频率在纵向上振动。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，提供最大运动的电流可能随各个器械而变，该电流值被存储在器械的非易失性存储器中因而可供系统使用。
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。具体地讲，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的直径越靠近刀片200越减小，纵向的前后移动被放大。因而，喇叭件124以及刀片/连结器的形状和尺寸可被确定为可放大刀片移动并提供与声学系统其余部分谐振的超声振动，这使靠近刀片200的声学安装喇叭件124的末端产生最大的前后移动。超声换能器组件114处20至25微米的运动可通过喇叭件124放大到约40至100微米的刀片移动。
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)使刀片200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施加的(如通过使用者调节选择的)电力(电流)的量成比例地变化。刀片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微米的范围内纵向移动。刀片200的这种超声振动能够在刀片接触组织时产生热量，即穿过组织的刀片200的加速运动将运动刀片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。刀片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。
如在图2中可见，超声器械110通过尾件驱动适配器130和远侧手柄适配器134支承在外壳102内。尾件驱动适配器130通过近侧轴承132可旋转地支承在外壳102内并且不可转动地连接于马达190的输出轴192上。参见图2。尾件驱动适配器130可被压配在超声器械110的外壳112上或(例如)通过固定螺钉或粘结剂附接于外壳112。远侧手柄适配器134可被压配在手柄外壳112的远端113上或通过固定螺钉或粘结剂连接于手柄外壳的远端上。远侧手柄适配器134可通过安装在外壳102内的远侧轴承136可旋转地支承在外壳102中。
当加电于马达190时，马达190将“显著旋转运动”施加在手柄110上而使超声外科器械110和刀片200绕中心轴线A-A转动。如本文所用，术语“显著旋转运动”与“扭转超声运动”不同，当使用非均匀成形的超声刀片时可实现该扭转超声运动。作为替代，“显著旋转运动”这个用语可涵盖非唯一地由超声换能器组件114导致的旋转运动。
为将来自超声发生器12的电力提供给超声器械110，可使用滑环组件150。如图2中可见，导线151、152附接于超声换能器组件114并延伸通过尾件驱动适配器130的中空杆部132。中空杆部132附装在马达190的传动轴192上并可在滑环组件150内自由旋转。第一内接触件154连接于中空杆部132以随其绕轴线A-A转动。第一内接触件154设置为在滑环组件150内与固定外接触环156旋转接触。接触环154、156可以被设置成同心环的形式。导线157、158连接于固定外接触环156，并构成为发生器电缆14。导线191和193连接于马达并构成为马达电缆74，导线195、197连接于编码器194并构成为编码器电缆70。马达轴192的旋转引起尾件驱动适配器130和与其连接的超声器械110绕轴线A-A旋转。马达传动轴192的旋转还引起内接触件154的旋转。来自超声发生器12的超声信号通过接触也就是在内接触件154和外接触件156之间的“电连通”被传输至内接触件154。这些信号通过导线151、152传输至超声换能器组件114。在其他可供选择的实施例中，滑环组件可使用接合同心接触环的普通弹簧针。也可使用其他滑环装置。
多种实施例还包括远侧突鼻件160，该突鼻件通过紧固件161可拆卸地附接于外壳102的远端103。参见图5。一个或多个垫片构件162可设置在远端103与突鼻件160之间，以便于外壳102和突鼻件160之间的同轴连接。突鼻件160可由(例如)不锈钢或聚碳酸酯制成。在多种实施例中，刀片200的远端202延伸通过套接在内部护套密封件212内的中空连结部210。内部护套密封件212可包括(例如)聚四氟乙烯(“PTFE”)并用于在连结部210与突鼻件160之间建立充分的液密和/或气密密封。还是在图4的实施例中，内部护套220可通过(例如)焊接连接于中空连结部210，或者中空连结部210可构成内部护套220的一体部分。在一个实施例中，刀片销钉/扭转件216可横向延伸通过刀片构件200和中空连结部210，以便于内部护套220与刀片构件200一起运动。一个或多个排放硅树脂套管214套接在刀片200周围以在声学上将刀片200与内部护套220隔离。刀片构件200可具有内部螺接的并能够可拆卸地接合连结器126的螺接部分的近端201。为了便于将刀片200紧固到连结器126上，可设置穿过外壳102的紧固孔108(图2)以使得工具(例如，艾伦扳手)可穿过其中插入到位于尾件驱动适配器130中的孔131中，以防止超声外科器械110和与其连接的连结器126的转动。一旦刀片200被螺接在连结器126上后，使用者可将艾伦扳手或其他工具从孔108、131移除并将螺纹塞(未示出)插入孔108中以防止流体/碎片由其进入外壳102。
同样在多种实施例中，外部护套230可与内部护套220和刀片构件200同轴对齐并通过(例如)焊接、钎焊、包覆成型或压力配合连接于突鼻件160的远端163。如在图4中可见，抽吸口240可附接于突鼻件160与中空护套230连通。柔性管242可附接于抽吸口240并与连接于一般地示为244的真空源的收集容器243连通。因而，外部护套230形成在内部护套220附近延伸的抽吸通道，其始于外部护套230的远侧顶端并从抽吸口240伸出。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，在可供选择的实施例中，可省略内部护套220。
手术系统10的多种实施例提供了选择性地将超声轴向运动施加到刀片200并将显著旋转运动也施加到刀片200的能力。如果需要，临床医生可仅启动超声换能器组件114而不启动马达190。在此类情况下，器械100可仅作为超声器械以超声模式使用。纵向超声运动的频率范围可为约(例如)30-80kHz。相似地，临床医生可能需要仅启动马达190而不启动超声换能器组件114。因而，能够以旋转模式对刀片200施加显著旋转运动而不对其施加纵向超声运动。显著旋转速度可为(例如)约1-6000rpm。在其他应用中，外科医生可能想要以超声和旋转模式使用器械100，其中刀片200将经历来自换能器组件114的纵向超声运动和来自马达的显著旋转运动。可实现(例如)每周期2到10转(720至3600度)的振荡运动或连续单向旋转。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手术系统10的多种实施例。
至少一个非限制性实施例还可包括设在外壳102上的控制装置170。参见图2。控制装置170可通过多芯电缆171与控制模块24连通。控制装置170可包括用于启动/关停包括“超声模式”和“旋转模式”的“双重”模式的第一按钮172。在此类装置中，可预先对控制模块24编程，以将预先设定的显著旋转运动量提供给刀片200。控制装置170还可包括用于启动/关停旋转模式而不启动超声模式的第二按钮174，从而在无止血作用的情况下进行切割。控制装置170还可包括用于启动/关停“凝固模式”的第三按钮176，其中马达190驱动至预设的旋转方位然后“停止”即关停，从而将超声刀片表面暴露在外部护套240的远端，如将在下文中进一步详细地讨论。同样在该模式中，可将超声换能器组件114通电以提供点状凝固，或在一个可供选择的实施例中，临床医生可以仅启动点状凝固按钮77，而该按钮则启动超声换能器组件114一段预设时间例如五秒钟。所述控制装置还可包括在超声和旋转模式之间切换的按钮178。根据多种非限制性实施例，在不脱离本文所公开的多种非限制性实施例以及它们的等同结构的精神和范围的情况下，上述功能/模式的任意组合可通过一个或多个按钮来组合结合和控制。
本领域的普通技术人员一般都了解，外壳构件102以及安装适配器130和134可被构造为可操作地支承其中的多种不同类型和形状的超声手柄，这些超声手柄可脱离外科器械100单独使用。因而，控制系统20和器械100可按不含超声手柄110的“套件形式”提供，以使得购买者能将他们的现有超声手柄安装在其中，而这并不脱离本文所公开的多种非限制性实施例及其等同结构的精神和范围。
图6和图7示出了另一外科器械300，其中先前用以描述上文所讨论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包括装有附接于超声喇叭324的换能器组件314的外壳302。超声喇叭324可按上述方式连接于刀片200的近端201。超声喇叭324可通过远侧轴承336可旋转地支承在外壳302内。突鼻件160可按上述方式通过紧固件161附接于外壳302。
在本实施例中，超声换能器组件314具有嵌入或以其他方式连接于其上的磁体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。导线332、334连接于马达定子环330并穿过共用的护套76以连接于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以形成导线151、152的通道。导线151、152附接于超声换能器组件314和内接触件154。内接触件154附接在中空轴340的一部分上，该中空轴可旋转地伸进滑环组件150，该滑环组件也支承在外壳302内。中空轴340通过近侧轴承342可旋转地支承在外壳302内。滑环组件150固定(即，不可转动)在外壳302内并包括连接于构成如上所述的发生器电缆14的导线157、158的固定外接触件156。马达定子330被供电时，导致转子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的超声信号通过旋转接触或者说在内接触件154与外接触件156之间的电连通被传输至内接触件154。这些信号通过导线151、152传输至超声换能器组件314。外科器械300可包括上述类型的控制装置并用于上述多种模式。可通过抽吸口240在刀片200与外部护套230之间施加负压。收集容器243和抽吸源240可通过管242附接于抽吸口240。刀片的远端通过在外部护套230远端中的窗口露出而将刀片暴露于组织，如将在下文中进一步讨论。
图8示出了另一外科器械400，其中先前用以描述上文所讨论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400包括装有附接于超声喇叭324的超声换能器组件314的外壳302。超声喇叭324可按上述方式连接于刀片200的近端201。超声喇叭324可通过远侧轴承336可旋转地支承在外壳302内。突鼻件160可按上述方式附接于外壳302。
在本实施例中，有刷马达410可一体附接于超声换能器组件314。文中所用的“一体连接”是指直接附接于超声换能器组件314或以其他方式与超声换能器组件一起形成，以随其移动。关于将有刷马达410附接于超声换能器组件314的方式所用的术语“一体连接”不包括其中超声换能器组件经由从动轴装置连接于马达的那些构造。同样在本实施例中，磁体426设置在定子环420中，而定子环固定在外壳302内。导线432、434延伸通过附接于有刷马达410的中空轴340。中空轴340通过近侧轴承342可旋转地支承在外壳302内。马达导线432连接于第一内部马达触点436，马达导线434连接于第二内部马达触点438。第一内部马达触点436和第二内部马达触点438支承在伸进滑环组件(一般地标示为450)的中空轴340部分上。滑环组件450固定(即，不可转动)在外壳302内并包括连接于导线441的第一外部马达触点440和连接于导线443的第二外部马达触点442。导线441、443构成如上所述的马达电缆74。当临床医生想要将显著旋转运动施加给超声换能器组件314并最终施加给刀片200时，临床医生使电力从马达驱动器26提供给有刷马达410。
同样在本实施例中，导线151、152附接于超声换能器组件314并延伸通过中空轴340与附接于中空轴340的内部换能器接触环154连接。滑环组件450包括连接于构成如上所述的发生器电缆14的导线157、158的固定外部换能器接触件156。有刷马达410被供电时，使马达410、超声换能器组件314和马达轴340绕轴线A-A转动。来自超声发生器12的超声信号通过旋转滑动接触或者说在内接触件154与外接触件156之间的电连通被传输至内接触件154。这些信号通过导线151、152传输至超声换能器组件314。外科器械400可包括上述类型的控制装置并用于上述多种模式。应当理解，器械400可用在如上所述的旋转模式、超声模式、旋转和超声模式(“双重模式”)或凝固模式中。可通过抽吸口240在刀片200与外部护套230之间施加负压。收集容器243和抽吸源240可通过管242附接于抽吸口240。刀片的远端通过在外部护套230远端中的窗口露出而将刀片暴露于组织，如将在下文中进一步讨论。
图9-13示出了另一外科器械500，其中先前用以描述上文所讨论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500包括装有附接于超声喇叭324的换能器组件530的外壳302。超声喇叭324可按上述方式连接于刀片200的近端201。超声喇叭324可通过远侧轴承336可旋转地支承在外壳302内。突鼻件160可按上述方式附接于外壳302。
本实施例包括马达510，该马达可包括上述类型和构造的步进马达并且可结合有与上述控制模块24连通的编码器部分。马达510可通过导线511、512接收来自马达驱动器26的电力，这些导线构成延伸通过共用护套76的马达电缆74。马达510具有附接于其上的中空马达轴520，该中空马达轴延伸通过滑环组件150。中空传动轴520通过近侧轴承342可旋转地支承在外壳302内。滑环组件150固定(即，不可转动)在外壳302内，并包括连接于构成如上所述的发生器电缆14的导线157、158的固定外接触件156。内接触件154安装在中空传动轴520上并与外接触件156电接触或连通。导线151、152连接于内接触件154并延伸通过中空传动轴520以附接于超声换能器组件530。
在多种实施例中，为了便于组装并有助于在声学上将马达与超声换能器组件530隔离，中空传动轴520可通过一般地标示为540的连接组件可拆卸地连接于超声换能器层叠件530。如在图9、11和12中可见，连接组件540可包括附接于中空传动轴520的远端521的薄板件542。薄板件542可由在轴向上具有相对低的刚度而在旋转上具有高刚度的材料制成。参见图12。例如，薄板件542可由0.008英寸厚的铝7075-T651制成并且可通过(例如)压力配合或钎焊附接于中空传动轴520的远端521。连接组件540还可包括超声换能器层叠件530的近端块即凸缘部分531。近端块531可包括(例如)由不锈钢制成的通过(例如)螺栓或其他连接方式附接于超声换能器组件530的凸缘。如在图11中可见，近端块531具有其尺寸确定为可在其中接纳薄板件542的孔532。在多种实施例中，薄板件542的尺寸可被确定为可压入孔532中，使得薄板件542绕轴线A-A的旋转能够引起超声换能器组件530绕轴线A-A转动。在其他实施例中，可提供单独的紧固件板(未示出)或按扣环(未示出)或按扣结构(未示出)以保持薄板件542与超声换能器组件530的近端块531不可转动地接合。此类结构用来使从超声换能器组件到马达的声学振动传递最小化。
图14和15示出了可使用的可供选择的薄板件542’。在本实施例中，薄板件542’具有设置在其中的多个径向凹口544以形成径向凸片546。孔532将形成有凹口(未示出)以在其中容纳径向凸片546。这样的结构可减小施加到轴520上的力矩。通过使用薄板件542、542’，可最小化从超声换能器组件530传递到传动轴520的声振动量。
当电力加于马达510时，传动轴520绕轴线A-A旋转，这也使换能器组件530绕轴线A-A旋转。当临床医生想要为超声换能器组件530通电时，将电力从超声发生器12提供给在滑环组件150中的固定接触件156。电力通过旋转滑动接触或者说在内接触件154与外接触件156之间的电连通传输到超声换能器组件530。这些信号通过导线151、152传输至超声换能器组件530。外科器械500可包括上述类型的控制装置并用于上述多种模式。应当理解，器械400可用在如上所述的旋转模式、超声模式、旋转和超声模式(“双重模式”)或凝固模式中。可通过抽吸口240在刀片200与外部护套230之间施加负压。收集容器243和抽吸源240可通过管242附接于抽吸口240。刀片的远端通过在外部护套230远端中的窗口露出而将刀片暴露于组织，如将在下文中进一步讨论。
图16示出了另一外科器械600，其中先前用以描述上文所讨论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600包括装有附接于超声喇叭324的换能器组件314的外壳302。在本实施例中，换能器组件314和超声喇叭324连接于PZT外壳602，后者通过远侧轴承336可旋转地支承在外壳302内。超声喇叭324可按上述方式连接于刀片200的近端。突鼻件160可按上述方式通过紧固件161附接于外壳302。
本实施例包括马达510，其可以包括上述类型和构造的步进马达。马达510可结合有与如上所述的控制模块24(图1)连通的编码器。马达510可通过导线511、512接收来自马达驱动器26(图1)的电力，这些导线构成延伸通过共用护套76的马达电缆74。马达510具有附接于其上的中空马达轴520，该中空马达轴延伸通过滑环组件150。中空传动轴520通过近侧轴承342可旋转地支承在外壳302内。
滑环组件150固定(即，不可转动)在外壳302内并包括连接于构成如上所述的发生器电缆14的导线157、158的固定外接触件156。内接触件154安装在可旋转的中空传动轴520上并与外接触件156电接触或连通。导线151、152连接于内接触件154并延伸通过中空传动轴520以附接于超声换能器组件314。在多种实施例中，为了便于组装并有助于在声学上将马达510与超声换能器组件314隔离，中空传动轴520可通过一般地标示为540的连接组件可拆卸地连接于PZT外壳602。连接组件540可包括附接于中空传动轴520的远端521的薄板件542。如上所讨论，薄板件542可由在轴向上具有相对低的刚度而在旋转上具有高刚度的材料制成。PZT外壳602具有近端部分604，该近端部分具有其尺寸确定为可在其中接纳薄板件542的孔603。在多种实施例中，薄板件542的尺寸可被确定为可压入孔603中，使得薄板件542绕轴线A-A的旋转能够引起PZT外壳602、超声换能器组件314以及超声喇叭324绕轴线A-A转动。在其他实施例中，可提供单独的紧固件板(未示出)或按扣环(未示出)或按扣结构(未示出)以保持薄板件542与PZT外壳602的近端部分604不可转动地接合。本实施例也可使用如上所讨论的薄板件542’。
电力供给到马达510时，传动轴520绕轴线A-A转动，其又引起PZT外壳602和超声换能器组件314绕轴线A-A转动。当临床医生想要为超声换能器组件314通电时，将电力从超声发生器12提供给在滑环组件150中的固定接触件156。电力通过旋转滑动接触或者说在内接触件154与外接触件156之间的电连通传输到超声换能器组件314。这些信号通过导线151、152传输至超声换能器组件314。外科器械500可包括上述类型的控制装置并用于上述多种模式。应当理解，器械400可用在如上所述的旋转模式、超声模式、旋转和超声模式(“双重模式”)或凝固模式中。可通过抽吸口240在刀片200与外部护套230之间施加负压。收集容器243和抽吸源240可通过管242附接于抽吸口240。刀片的远端通过在外部护套230远端中的窗口露出而将刀片暴露于组织，如将在下文中进一步讨论。
为了减小用于器械300、400、500和600每一个中的外壳302的总体尺寸，用于那些相应器械每一个中的超声换能器组件可由物理长度较短的半波换能器代替。
超声刀片和护套实施例
当前的关节镜工具包括冲头、往复式剃刀和射频(RF)动力装置。机械装置(诸如冲头和剃刀)趋于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动力刀片能留下较光滑的切割线并且还能消融大量的软组织。然而，此类装置会比纯机械器械造成更多的组织损伤。上述多种非限制性外科器械实施例提供了许多优于常规RF动力外科器械以及使用旋转组织切割构件的常规机械剃刀的优点。如将在下文中进一步详细地讨论，通过使用多种非限制性实施例独特新颖的刀片和护套构造可实现另外一些优点。
图17-21示出了可结合上述多种外科器械使用的一种形式的刀片200和外部护套230。如在那些图中可见，刀片200可具有远端部分700并且外部护套230可具有远端部分720。刀片200可由(例如)钛制成，并且外部护套230可由(例如)聚醚醚酮(“PEEK”)、Ultem
或不锈钢制成。如上所讨论，刀片200可具有按已知方式被构造成以螺纹或其他方式附接于超声喇叭324(图6-10和16)的波导或近端部分。刀片200的远端部分700可具有形成于其上的弯曲顶端部分702。弯曲顶端702可具有弓形顶部704，该弓形顶部具有形成在每个侧面705上的切割刃706。切割刃706可在远侧终止于共同的、大致尖的远端708。所述尖的远端708可相对较钝，或者所述尖的远端708可具有较为锋利的尖端。如在图20中可见，所述尖的远端708可绕刀片的中心轴线A-A向内弯曲。如在图19中可见，在多个实施例中，切割刃706可不彼此相交而是可被中心部分707分开。如在图20中可见，刀片200可具有从波导或近侧刀片部分712向远侧突出的缩小的颈部710。在颈部710从近侧部分712突出的区域形成节点714。
如在图17中可见，外部护套230也具有远端部分720，该远端部分具有形成在其中的窗口即开口722以露出刀片200的远端部分700。在图17中还可见，外部护套230可包括具有基本上钝的末端724的中空圆柱体。在多种实施例中，窗口722的延伸距离为外部护套230的圆形横截面的一半。这样的窗口构造可形成绕钝的末端724延伸的弓形凸缘725。在多种实施例中，外部护套230可由(例如)聚醚醚酮(“PEEK”)、Ultem
或不锈钢制成。为了防止在刀片200远端部分700上的切割刃706与凸缘725之间的金属间相互接触，可通过例如粘合剂或围绕凸缘724的T形槽附接上聚合物护挡726。参见图17。护挡726可由(例如)Teflon、硅树脂或其他减摩擦或低摩擦材料制成。护挡726的尺寸可被确定成产生与切割刃706和尖的远端708(例如)0.005英寸的过盈配合。
在使用中，当刀片200在外部护套230内绕轴线A-A转动并被引入组织时，组织通过施加在内部护套220(图4)与如上所述的外部护套230之间的负压被吸入窗口722中。然后，当切割刃706旋转经过护挡726时被吸入窗口722中的组织被切割，而被切割的组织可经过内部护套220和外部护套230之间并通过抽吸口240(图4、6-10和16)排出到收集容器243(图4、6-10和16)中。
在另一个实施例中，可通过刀片200的颈部710提供轴向抽吸通道730。参见图20。轴向抽吸通道730可与节点714区域中的横向抽吸通道732连通。因而，被切割的组织可穿过通道730、732并经过内部护套220和外部护套230之间并通过抽吸口240(图4、6-10和16)排出到收集容器243(图4、6-10和16)中。图21示出了可供选择的实施例，其中两个退出通道734、736与轴向通道730连通并以一定的角度从其延伸。在多种实施例中，退出通道734、736可以(例如)四十五(45)度的角度738从轴向通道730延伸。这种构造可用于减少在超声启动期间可能由于通过外部护套230的窗口722吸入的水造成的阻力和功率损失。
在使用中，临床医生可选择在不向刀片200施加超声运动的情况下在外部护套230内旋转刀片。临床医生还可选择向旋转刀片施加超声运动或者临床医生可能希望向停止的(不旋转)刀片施加超声运动以使用暴露在窗口722中的刀片部分来凝固组织。
图22示出了结合具有远端部分750的外部护套230的刀片200的使用，该远端部分包括向远侧突出的鼻段752。在多种实施例中，鼻段752可具有弧形宽度“W”，该弧形宽度占外部护套230远端部分750的圆周的大约百分之十(10)至百分之三十(30)。鼻段752可从外部护套230的远端部分750的端部向远侧突出可为约(例如)0.25英寸的长度“L”。在可供选择的实施例中，可根据需要将低摩擦护挡即防护件(未示出)设于鼻段752的侧边753上。这些实施例可以与先前实施例类似的方式运行。然而，本实施例具有用暴露的顶端切割组织的附加能力。正如其他实施例一样，临床医生可在没有或有超声运动的情况下将显著旋转运动施加给刀片200。在另一种可供选择的使用方法中，在刀片未旋转或振动时，可使用暴露的刀尖708和部分暴露的切割刃706切割组织。
图23-24示出了另一个非限制性刀片和外部护套实施例。在本实施例中，刀片200的远端部分760基本上类似于上述刀片构造的远端部分700。然而，远侧刀片部分760不向内弯曲相同度数以使得刀尖762不与中心轴线A-A相交。参见图24。如在图23中可见，外部护套230的远端部分720中的窗口722’不延伸从端壁725到钝的顶端724的整个距离。因而，在本实施例中，所述钝的顶端724包括扩展到90°但小于180°(即，图23A中的角“A”大于90°但小于180°)的鼻部。
图25和26示出了另一个非限制性刀片实施例。在本实施例中，刀片200’可基本上类似于刀片200或本文所述的任何其他刀片。在本实施例中，远端700’具有粗糙上表面705’。此粗糙表面705’在刀片200’的远端部分700’与组织之间产生较高的摩擦力，以将组织牵引进外部护套230的远端部分720中的窗口722’(图26)。通过将更多的组织拉入窗口722中，刀片200’的前沿切割刃706’干净地切割组织的可能性可更高。在多种实施例中，例如，所述粗糙表面可通过滚花形成或者可在其上表面涂覆诸如金刚石等硬质材料。
图27-29示出了另一个非限制性刀片实施例。在本实施例中，刀片200”可基本上类似于本文所述的刀片200。在本实施例中，远端700”具有一系列从上表面705”向外突出的径向延伸的切割齿707以当刀片200”在外部护套230内旋转时拉引和切割组织。
图30、31和32A-D示出了另一个非限制性刀片和外部护套实施例。在采用外部护套内的旋转刀片的多种器械的使用中，存在当刀片在其中旋转时组织可能被“逐出”护套窗口的情况。这会由于组织未被充分捕获并保持在切割刃之间而导致切割速率降低。本实施例的刀片800解决了此类可能的缺点。
如在图30中可见，除了在本文提及的差异外，刀片800可基本上与刀片200相同。具体地讲，刀片800可包括终止于远端部分810的颈部803。远端部分810可具有稍微弯曲的刀尖812。一系列的齿817可设置在远端部分810的至少一个侧面813或815上。在图32A-D所示的实施例中，齿817和819分别形成在远端部分810的侧面813、815上。远端部分810还具有稍微呈穹顶形的顶部821。在图30-32D所示的实施例中，齿817包括较为锋利的尖端，它们之间限定有一系列弓形开口823。齿819也包括较为锋利的尖端，这些尖端之间有一系列弓形开口825。如图30所示，可设置通过刀片800的颈部803的轴向抽吸通道805。轴向抽吸通道805可与节点808区域中的横向抽吸通道807连通。因而，被切割的组织可经过通道805、807并在内部护套(未示出)与外部护套850之间出来并以上述方式通过抽吸口排出到收集容器中。也可成功地使用其他抽吸通道构造。
外部护套850可基本上类似于上述外部护套230并具有与其连接的远侧护套顶端850，该远侧护套顶端具有形成在其中的窗口即开口854以露出刀片800的远端部分810。参见图31。外部护套850可包括由(例如)不锈钢制成的中空圆柱体。在多种实施例中，窗口854延伸到外部护套850的圆形横截面的大约一半距离并在其中形成刀片开口858。远侧护套顶端850可由金属(例如，不锈钢)制成，使得较为锋利的切割刃860在刀片开口858附近延伸。所述锋利的切割刃860可具有第一侧向切割刃部862和第二侧向切割刃部864，以便于说明。
图32A-D示出了在外部护套850内刀片800的顺序旋转。首先来看图32A，示出了刀片800正以逆时针“CCW”方向旋转。如在该图中所示，在刀片800第一侧面813上的切割齿817被设置成可剪切位于齿817与切割刃860第一侧向切割刃部862之间的组织(未示出)。当位于该位置时，在齿817之间的弓形开口823露出而共同形成在刀片800与远侧护套顶端850之间的第一侧向抽吸通道870，以使组织能够通过经由抽吸通道805(图30)施加的负压被吸入其中。随着该旋转顺序继续，刀片800的穹顶形上部821覆盖远侧护套顶端850中的开口854，以至于不存在露出的抽吸通道供组织进入开口854。当刀片继续其旋转时，图32C示出了齿819之间的弓形开口825共同地形成位于第二侧向切割刃部864与刀片800之间的第二侧向抽吸通道872，以使得组织能被吸入其中。随着刀片800继续以逆时针方向旋转，第三抽吸通道874露出而使得组织能够被更多地吸入开口854中。因而，此构造使得抽吸通道能够从刀片开口858的一个到另一个侧面顺序打开，以便于更好地切割组织。在使用中，临床医生可选择在不向刀片800施加超声运动的情况下在外部护套850内旋转刀片。临床医生还可选择向旋转刀片施加超声运动，或者临床医生可希望向停止的(不旋转)刀片施加超声运动以用露出于开口854的刀片部分来凝固组织。
图33和34示出了另一个刀片实施例880，本实施例除了下述差异之外可基本上与刀片200相同。具体地讲，刀片880可包括终止于远侧组织切割部884的波导或近侧部分882。刀片880的近侧部分882可被构造为通过螺纹或其他方式附接于上文讨论的多种实施例中任何一个的超声喇叭上。远侧组织切割部884可具有形成在其中的相对的弓形斜槽部分886、888。第一弓形斜槽部分886可限定第一切割刃890而第二弓形斜槽部分888可限定第二切割刃892。本刀片实施例可结合上述的外部护套构造中的任何一个使用。在所示的实施例中，使用例如可类似于外部护套230的中空护套900，并且其包括具有圆形或钝的鼻部902和窗口904的远侧护套顶端901。中空护套900可由(例如)不锈钢制成并且远侧护套顶端901可由金属(例如，不锈钢)制成。窗口904形成与刀片880上的切割刃890、892配合的弓形切割刃906，以当刀片880以上述多种方式在外部护套900内旋转时切断组织。在至少一个实施例中，刀片880的近侧部分882的尺寸可确定成相对于中空护套900在其间形成间隙，以例如能够按上述方式在间隙处施加负压。如在图34中可见，当刀片880旋转时(由箭头“R”表示)，弓形斜槽部分886、886限定了在刀片880的远端884与远侧护套顶端901的壁之间的开口894、896，以使得组织能够通过施加到外部护套900的内壁与刀片800的颈部882之间区域的负压(由箭头“S”表示)被吸入其中。还将认识到，刀片880可按逆时针或顺时针方向旋转或选择性地在这两个旋转方向之间摆动并仍然有效地切割吸入其中的组织。图34A示出了由金属材料(例如不锈钢)制成的可供选择的护套顶端实施例901’，其具有一系列形成在每个切割刃890’、892’上的锯齿状切割齿905’。
图35示出了另一个刀片实施例910，本实施例除了下述差异之外可基本上与刀片200相同。具体地讲，刀片910可包括终止于远侧组织切割部914的波导或近侧部912。刀片910的近侧部912可被构造为通过螺纹或其他方式附接于上文讨论的多种实施例中任何一个的超声喇叭上。远侧组织切割部914可具有形成在其中并且配合以限定第一切割刃920和第二切割刃922的相对的斜槽部分916。本刀片实施例可结合上述多种外部护套构造任一种而使用，并被设计成仅以单个方向“R”旋转来切割组织。与上述实施例一样，弓形斜槽部分916限定在刀片910的组织切割部914与远侧护套顶端的内壁之间的开口，以在负压被施加到近侧部912与外部护套的内壁之间的区域时组织能够被吸入其中。
图36示出了另一个外科器械2000，其中先前用以描述上文所讨论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2000包括装有附接于超声喇叭324的超声换能器组件314的外壳302。在本实施例中，超声换能器组件314和超声喇叭324可按已知的方式不可旋转地支承在外壳302内。可将电控制信号通过导线151、152从超声发生器12提供给超声换能器组件314。超声发生器12的启动能够使超声换能器组件314将超声运动施加给超声喇叭324。在本实施例中，中空护套2010附接于超声喇叭324以接收来自超声喇叭的超声运动。例如，在多种实施例中，外部护套2010可通过螺纹连接或其他合适的紧固构造附接于超声喇叭324。
本实施例包括可旋转的刀片2020，其可旋转地支承在外部护套2010内并连接于支承在外壳302内的马达510。马达510可包括(例如)上述类型和构造的步进马达。马达510可结合有与如上所述的控制模块24(图1)连通的编码器。刀片2020可具有中空远侧部分2022和实心近侧部分2024。参见图36A。实心近侧部分2024可通过螺纹或其他合适的连接方式附接于马达传动轴520。马达传动轴520可通过近侧轴承342可旋转地支承在外壳302内。当将控制信号提供给马达510时，传动轴520绕轴线A-A旋转，这也引起刀片2020在外部护套2010内绕轴线A-A旋转。
图36A中还可见，中空护套2010被支承于其中具有抽吸口240的中空突鼻件160内。柔性管242可附接于抽吸口240并与连接于一般地示为244的真空源的收集容器243连通。中空护套2010可通过近侧密封件2013和远侧密封件2015支承在突鼻件160内，所述近侧密封件和远侧密封件位于如图36A所示的抽吸口240的两侧并用来在其间形成液密密封。中空护套2010设置有与近侧密封件2013和远侧密封件2015之间的抽吸口240配准的至少一个近侧护套开口2014。另外，刀片2020的中空远侧部分2022通过至少一个近侧刀片密封件2025和远侧刀片密封件2027可旋转地支承在中空护套2010内。至少一个刀片排放口2028可通过刀片2020的中空部分2022设置在近侧刀片密封件2025和远侧刀片密封件2027之间，以排放到至少一个近侧护套开口2014中。
同样在多种实施例中，中空护套的远端部分2011封闭并且至少一个开口或窗口2012设于其中，以露出刀片2020的远侧组织切割部2025。在至少一个实施例中，窗口2012包括细长狭槽并且远侧组织切割部也包括刀片2020中的细长狭槽2026(图37和38)。因而，负压可通过抽吸口240、近侧护套开口2014和刀片排放口2028从抽吸源244施加到刀片2020的中空部分中。当远侧开口2026、2012相迭合时，组织“T”可被抽吸到刀片2020的中空远侧部分2022中，如图38所示。组织“T”的切断部分可通过刀片2020的中空远侧部分2022，由开口2028、2014排出到收集容器243中。
在使用中，临床医生可启动旋转刀片2020以切割和排出组织。当遇到易出血者时，临床医生可启动超声换能器组件314以将超声运动发送给外部护套2010以实现凝固目的。例如，由于多种疾病状态，脊柱融合手术需要移除椎间盘材料。很多时候，该材料变得坚韧并需要用常规器械施加相当大的力以使椎间盘破碎并移除其碎片。一旦移除了椎间盘材料，就必须刮擦终板以显露新生表面，从而促进终板与融合器(cage)的融合。终板还须形成合适的形状，以与所用类型的融合器良好贴合。常规器械通常需要外科医生在非常靠近关键结构处施加大力。在其他实施例中，可连接马达以转动超声换能器组件并且可将刀片如上所述附接于超声换能器组件，以使得刀片转动并可具有施加于其上的超声运动。
当进行(例如)如图39和40所示的椎间盘切除术时，使用上述外科器械2000可能特别有利。如这些附图所示，外部护套2010可插入椎间盘“D”中。旋转刀片2020可用来刮掉椎间盘的碎片并将碎片吸出。这种构造可免除重复地插入/移除外科工具之需。所述装置也可用来制备椎体终板。在图41-45所示的实施例中，旋转切割刀片2020具有一系列的形成在远侧开口2026至少一侧上的锯齿状齿2021，以进一步有助于切割通过外部护套2010中的开口2012吸入的组织。同样在本实施例中，可缩回的防护罩2040可移动地安装在外部护套2010上并可选择性地从基本上覆盖外部护套2010中的开口2012的关闭位置移动到暴露开口2012的打开位置(图43和44)。在靠近重要神经和其他关键组织插入和移除外部护套2010的过程中，这种构造可将刀片2020上的齿2021覆盖。为了便于安全护套2040在外部护套2010上的移动，可在安全护套2040的近端上形成拇指控制键2042(图41和45)以使得临床医生能够向其施加滑动推力。另外，在多种实施例中，可在安全护套2040上形成保持凸起2044，以接合设置在外部护套2010中的至少一个卡位或凹槽2046以将安全护套2040保持在对应的打开或关闭位置。例如，一个卡位或凹槽2046可对应于关闭位置(其中安全护套2040覆盖开口2012)，另一个卡位或凹槽2046’可对应于部分打开位置(其中开口2012露出一部分)，并且另一个卡位或凹槽2046”可对应于完全打开位置(其中开口2012全部露出)。
图46-51示出了具有几乎直的远侧组织切割部942的刀片940。当将刀片940用在含水环境中时，与用于该环境的多种其他刀片构造的阻力和功率要求相比，这种刀片构造可减小可能的阻力和功率增加。也就是说，此类相对直的刀片设计可需要较少的动力即能在含水环境中运行。当刀片940结合上述外部护套230使用时，刀片940可具有圆的或钝的远端944以及形成切割刃947、948以切割组织的凹槽946。凹槽的长度“L”可为(例如)一(1)英寸。刀片942也可具有上述类型和构造的抽吸通道730。如图47所示，可在外部护套230的外露远端部分720附近使用上述类型和构造的低摩擦护挡即垫片726。图48-51示出了刀片940的可供选择的横截面形状，其中采用了不同成形的凹槽946。
图52-55示出了另一个非限制性刀片和护套实施例。本实施例采用中空护套950，其可通过任何合适的紧固方法或连接构造附接于任何上述外科器械的突鼻件或超声换能器组件。如在图55中可见，外部护套950具有封闭的修圆或修钝的鼻部952以及细长的矩形窗口即开口954。在一个实施例中，例如，矩形窗口954的宽度“W”为中空护套950圆周的约四分之一、长度为约0.25英寸。外部护套950可由(例如)不锈钢制成。
本实施例也采用可结合任何上述外科器械实施例或其他实施例使用的刀片960。例如，波导或刀片的近侧部分可被构造成可通过螺纹或其他连接方式附接于器械的超声喇叭或马达传动轴。如在图52-54中可见，刀片960具有一对形成于其上的径向相对的锋利切割刃962，其用于切割被抽吸到外部护套950的窗口954中的组织“T”。在多种实施例中，刀片960可由(例如)钛制成并且其尺寸相对于外部护套950确定成使得在外部护套950的内壁951与径向相对的锋利切割刃962的顶端之间形成间隙“C”。参见图54。在一些实施例中，例如，间隙“C”可为约0.001英寸。在本实施例中，刀片960可由(例如)钛制成并具有平的远端964。在使用中，当将显著旋转运动以上述多种方式中的任一种施加到刀片960上并且在中空护套950内加负压时，组织“T”通过窗口954被抽吸进来并捕获在刀片960与外部护套950的内壁951之间。当例如所述装置被用在将于下文中进一步详细讨论的含水环境中时，该动作可分离出其长度足以切割的组织“T”。在一些实施例中，切割刃962可以是锯齿状的。在其他实施例中，切割刃962不是锯齿状的。
图57示出了另一个非限制性刀片和护套实施例。本实施例采用中空护套970，其可附接于上述多种器械中任一种的突鼻件或超声换能器组件。如在图56中可见，外部护套970具有修圆或修钝的鼻部972和在鼻部972中形成刀片出入孔976的细长窗口即开口974以及两个径向相对的侧向窗口部978。在例如其中外部护套970的外径为约0.157英寸的一个实施例中，刀片出入孔976的直径可为约0.125英寸。侧向窗口部978的宽度“W”可各为约0.090英寸并且长度“L”为约0.25英寸。可采用其他的窗口尺寸/构造。外部护套970可由(例如)不锈钢制成。
本实施例也可采用刀片980，其具有被造成可通过螺纹或其他合适的连接方式附接于上述多种外科器械实施例中任一种的超声喇叭324或马达传动轴的波导或近侧部分。在多种实施例中，刀片980可基本上与上述刀片960(具有径向相对的锋利切割刃982)相同，不同的是刀片980具有通过外部护套970中的刀片出入孔976突出的修圆/大致修钝的远侧顶端部分984。参见图57。在多种实施例中，刀片980可由(例如)钛制成并且其尺寸相对于外部护套970确定成使得在外部护套970的内壁971与径向相对的锋利切割刃962的顶端之间形成间隙。在一些实施例中，例如，间隙可为约0.001英寸。在使用中，当将显著旋转运动以上述多种方式任一种施加到刀片980上并且在中空护套970内施加负压时，组织通过窗口部分978被抽吸进来并捕获在刀片980与外部护套970的内壁971之间。当例如所述装置被用在将于下文中进一步详细讨论的含水环境中时，该动作可分离出长度足以供切割的组织。同样在本实施例中，当刀片980接通超声动力时，临床医生能使用暴露的远侧顶端部分984实现纤维组织点消融或点凝固的目的。在一些实施例中，切割刃982可以是锯齿状的。在其他实施例中，切割刃982不是锯齿状的。
图59示出了另一个非限制性刀片和护套实施例。本实施例采用中空外部护套990，其可通过任何合适的紧固方法或连接构造附接于任何上述外科器械的突鼻件或超声换能器组件。如在图58中可见，外部护套990具有封闭的修圆或修钝的鼻部992和细长的矩形窗口即开口994。在一个实施例中，例如，矩形窗口994的宽度“W”为约0.100英寸以及长度为约0.25英寸。外部护套990可由(例如)聚酰胺或不引起刀片1000与其接触而产热的类似材料制成。窗口994可由锋利刃口995、997限定。如在图60中可见，刃口995、997其间可具有角“B”。在一些实施例中，角“B”可为约110度。
这些实施例也采用刀片1000，其具有能够通过螺纹或其他合适的连接构造附接于任何上述外科器械或其他器械的超声喇叭或马达传动轴的波导或近侧部分。如在图59中可见，刀片1000可具有一对形成于其上的径向相对的锋利切割部1002，其用于切割被抽吸到外部护套990的窗口994内的组织。在多种实施例中，刀片1000可由(例如)钛制成。刀片1000的切割部1002可具有形成于其上的锋利的切割角1003。在一些实施例中，切割角1003可以是锯齿状的。在其他实施例中，切割角1003不是锯齿状的。切割部1002的尺寸可相对于外部护套990确定，以当刀片1000在外部护套990内来回转动或摆动时在切割角1003与窗开口994的锋利刃口995、996之间建立组织剪切动作。刀片1000的尺寸可相对于外部护套990确定，以在其间建立滑动配合，而这以另一种方式防止了组织被夹入在这两个部件之间。刀片990可来回(箭头“D”)转动或沿单一方向(箭头“E”)转动，并且在需要时可启动超声，如上所讨论。参见图59。在使用中，当将显著旋转运动以上述多种方式中的任一种施加到刀片1000上并且在中空外部护套990内加负压时，组织“T”通过窗口994被抽吸进来并捕获在刀片1000与外部护套990的内壁999之间。当例如所述装置被用在将于下文中进一步详细讨论的含水环境中时，该动作可分离出长度足以供切割的组织。
图62示出了另一个非限制性刀片和护套实施例。本实施例采用中空护套1010，其可通过任何合适的紧固方法或连接构造附接于任何上述外科器械的突鼻件或超声换能器组件。如在图61中可见，外部护套1010可具有封闭的修圆或修钝的鼻部1012和细长的矩形窗口即开口1014。在一个实施例中，例如，窗口1014具有第一模制或凹陷刃口1016和第二模制或凹陷刃口1018，限定宽度“W”可为约0.100英寸的开口1019。窗口1014的长度可为约0.25英寸。外部护套1010可由(例如)不锈钢制成。
这些实施例也采用刀片1020，其具有能够通过螺纹或其他合适的连接方式附接于任何上述外科器械或其他器械的超声喇叭或马达传动轴的波导或近侧部分。如在图62中可见，刀片1020可具有一对形成于其上的径向相对的锋利切割部1022、1024。刀片1020可由(例如)钛制成并具有形成于每个切割部1022、1024上的较锋利的切割角1025。在一些实施例中，切割角1025可以是锯齿状的。在其他实施例中，切割角1025不是锯齿状的。切割部1022、1024的尺寸可相对于外部护套1010确定，以当刀片1020在外部护套1010内转动或摆动时在凹陷刃口1016、1018与切割角1025之间建立组织剪切动作。此构造形成相对小的局部区域以减轻刀片与外部护套之间的接触问题，同时也可促进对于组织的剪切作用。在使用中，当将显著旋转运动以上述多种方式任一种施加到刀片1020上并且在中空护套1010内加负压时，组织通过窗口1019被抽吸进来并捕获在刀片1020与外部护套1010的内壁1011之间。当例如所述装置被用在将于下文中进一步详细讨论的含水环境中时，该动作可分离出长度足以供切割的组织。
图64示出了另一个非限制性刀片和护套实施例。本实施例采用中空护套1030，其可附接于任何上述外科器械的突鼻件或超声换能器组件。如在图63中可见，外部护套1030可具有封闭的修圆或修钝的鼻部1032和细长的矩形窗口即开口1034。本实施例可以还包括一对锋利的刀片1036、1038。刀片1036、1038可由(例如)硬化不锈钢制成并通过(例如)焊接附着在中空护套1030内。窗口1034的宽度“W”可为约0.100英寸并且长度可为约0.25英寸。外部护套1030可由(例如)不锈钢制成。
这些实施例也可采用刀片1040，其具有能够通过螺纹或其他合适的连接方式附接于本文所述的任何外科器械或其他器械的超声喇叭或马达传动轴的波导或近侧部分。如在图64中可见，刀片1040具有一对形成于其上的径向相对的切割部1042，其具有较锋利的切割角1043。在一些实施例中，切割角1043可以是锯齿状的。在其他实施例中，切割角1043不是锯齿状的。在多种实施例中，刀片1040可由(例如)钛制成并且其尺寸相对于刀片1036、1038确定，以当刀片1020在中空护套1030内转动或摆动时在锋利的切割角1043与切割部1042之间建立组织剪切动作。刀片1020的外径小于外部护套1030的内径，以在运转过程中为刀片1040提供间隙。唯一的接触情况会沿着窗开口1034(其中通过抽吸拉入了组织)发生在刀片1040的切割部1042和刀片1036、1038之间。
图66示出了另一个非限制性刀片和护套实施例。本实施例采用中空护套1110，其可通过任何合适的紧固方法或连接构造附接于上述任何外科器械的突鼻件或超声换能器组件。如在图65中可见，外部护套1110可具有封闭的修圆或修钝的鼻部1112和细长的矩形窗口即开口1114。在本实施例中，窗口1114的侧向刃口部1116、1118向内模制或凹陷。窗口1014的宽度“W”可为约0.10英寸并且长度可为约0.25英寸。
这些实施例也采用刀片1120，其具有被构造成通过螺纹或其他合适的连接构造附接于任何上述外科器械实施例或其他实施例的超声喇叭或马达传动轴的波导或近侧部分。如在图66中可见，刀片1120具有一对形成于其上的径向相对的切割部1122，其具有较锋利的切割角1023。在一些实施例中，切割角1023可以是锯齿状的。在其他实施例中，切割角1023不是锯齿状的。在多种实施例中，刀片1020可由(例如)钛制成并且其尺寸相对于凹陷刃口1116、1118确定，以当刀片1120转动或摆动时在锋利的切割角1023与切割部1122之间建立组织剪切动作。此类构造限定刀片1120的切割部1122与外部护套1110的内壁1111之间的较大间隙C1。为在侧向刃口1116、1118与切割部1122之间形成组织剪切动作，提供了小于C1的间隙C2。
图67-69示出了另一个非限制性刀片和护套实施例。本实施例采用中空护套1210，其附接于上述任何外科器械的突鼻件或超声换能器组件。中空护套1210具有远侧鼻部1212，其包括用于限定弓形横侧部1216、1218的上开口1214和下开口1215。远侧鼻部1212还可具有在横向侧部1216、1218之间延伸的封闭端1219。
本实施例还包括刀片1220，其具有被构造成附接于任何上述外科器械的超声换能器组件的波导或近侧部分。刀片1220还具有远端部分1221，该远端部分具有腔体1222，用于限定在中空护套1210的弓形横侧部1216、1218上方延伸的一对弓形切割部1224、1226。切割部1224、1226中的一者或二者可具有锯齿形齿1227或二者都不具有锯齿形齿。在图67所示的实施例中，腔体1222具有大致类似于平底“C”的横截面形状。然而，腔体1222也可具有其他横截面形状。如图所示，至少一个抽吸通道1230可设置为穿过刀片1220。该抽吸通道可与抽吸源(未示出)连通。
在多种实施例中，刀片1220可由(例如)钛制成并且其尺寸相对于中空护套1210的远侧鼻部1212确定，使得刀片1220的底部1232向下延伸出鼻部1212的侧面1216、1218。同样地，弓形侧部1224、1226的切割刃延伸到侧面1216、1218的上方，如图67所示。刀片1220的外露底部1232可用来(例如)凝固组织，而切割刃1224、1226可用于切割和切断组织。
中空护套1210的近端1211从手柄外壳1240突出，如图70所示。手柄外壳1240内装有如上所述的超声换能器组件、马达和滑环组件并连接于控制系统10。手柄外壳1240可包括使临床医生能够在第一“超声”模式1242、第二“剃刀”模式1244和第三“注射”模式1246之间切换的选择开关1241。切换机构1241与控制系统10连通以自动将刀片1220按所需的旋转方位取向。例如，为了以超声模式1242使用装置1200，临床医生将选择开关1241切换到超声模式位置1242(图71中示为动作1250)。当处于第一超声构造1242时，马达将转动刀片1220至图67和68所示的位置(图71中示为动作1252)然后停在该位置以通过中空护套1210露出刀片1220的底部1232(图71中示为动作1254)。当处于该位置时，启动超声换能器组件以使得底部1232能被用于实现止血(图71中示为动作1257)。更具体地讲，当处于超声模式1242时，临床医生可相对于正在出血的组织对底部1232取向，然后用刀片1220的外露部1232向组织施加稳定的力(图71中示为动作1256)。然后，临床医生启动超声换能器组件以实现止血(图71中示为动作1258)。在可供选择的实施例中，装置1200可设有如上所述的与控制系统连通的一系列开关/按钮，使得开启一个开关可引发转动。开启另一个开关可引发旋转摆动，开启又一个开关可配合控制系统将刀片转动至超声位置并停止，其后启动超声换能器组件，或者在其他实施例中，超声换能器组件可由另一个单独的开关启动。所有此类可供选择的构造均在本文所公开的多种非限制性实施例及其相应的等同结构的范围内。
图72示出了当处于剃刀模式1244时装置1200的使用。具体地讲，将选择开关1241移动到剃刀位置1242(图72中示为动作1260)。当处于该位置时，马达在中空护套1210内连续转动刀片1220(图72中示为动作1262)。在其他实施例中，马达可在外部护套1210内可旋转地来回摆动刀片1220，或者在其他实施例中选择开关可移动到引发旋转式摆动的另一位置。在任一种情况下，临床医生可随后用旋转或摆动的刀片(1220)接触组织以使得组织被刮掉并通过抽吸通道1230排出(图72中示为动作1264)。
图73示出了当处于注射模式1246时装置1200的使用。具体地讲，将选择开关1241移动到注射位置1246(图73中示为动作1270)。当处于该位置时，刀片1220被保持在停止位置(图73中示为动作1272)。然后，临床医生可将刀片取向在所需的位置然后注射所需的药剂(图73中示为动作1274)。一种可注射的药剂形式例如可包括以商标“Carticel”销售的细胞生成药物。然而，也可使用其他药物和药剂。通过以下方式可完成注射动作：将刀片1220在外部护套1210内取向到某一位置，使得延伸通过刀片1220的药剂通道1284通过外部护套1210露出来，以使药剂能够被有利地施加到邻近位点。然后，可通过启动与药剂源1282连通的泵1280注射药剂。参见图70。在多种实施例中，装置1200可具有与泵1280连通的注射扳机1249，使得注射扳机1249的启动能够使泵1280将药剂通过通道1284射出(图68)。在可供选择的实施例中，药剂可通过(例如)注射器人工注射进与刀片1220中的药剂通道1284连通的口(未示出)。
图74-77示出了另一个非限制性外科器械实施例1300。装置1300可包括上述手柄装置300、400、500中的任何一个。例如，装置1300可包括具有下述差异的手柄300。手柄300包括具有附接于超声换能器组件的波导或近侧部分的刀片200，超声换能器组件被启动时将超声运动加于刀片200。如上所述，刀片200还可由手柄300内装有的马达装置转动。刀片200可延伸通过从手柄300突出的内部护套1320。刀片200在内部护套1320内处于自由状态，可选择性地振动和转动。一个或多个密封构件1322可设置在刀片200与内部护套1320之间，以防止流体和组织进入内部护套1320与刀片200之间的区域。密封构件1322可由例如硅橡胶(silastic silicone)制成。
装置1300还可包括可移动地接纳在内部护套1320上的外部护套1330。外部护套1330的尺寸可相对于内部护套1320确定，使得抽吸管1350可在一部分内部护套1320与一部分外部护套1330之间延伸。抽吸管1350可与一般地示为1352的抽吸源连通。参见图74。如在图74-77中可见，外部护套1330可包括从外部护套1330的远端部分1331向远侧突出的摆臂部1332。摆臂1332可为相对直的(图75)或可具有稍微弯曲的远端1334(图76)。如在图76中可见，远端1334可具有在其上的锋利切割面1336。同样在图74-76中可见，在一些实施例中，刀片200可具有弯曲的刀尖1360，该弯曲的刀尖具有一对形成于其上的侧向切割刃1362。在其他实施例中，刀尖1360可以是直的。在一些实施例中，刀片200可以上述多种方式旋转。在其他实施例中，刀片200可不旋转。在此类实施例中，例如，临床医生可选择不启动使刀片旋转的马达或者手柄可以是不包括用于转动刀片的马达的手柄。
在使用中，摆臂部1332可覆盖刀片200的远端1360的某些部分。在一种使用模式中，外部护套1330被保持到位，其中摆臂部1332覆盖刀片200的后侧，如图74所示。此构造将弯曲的刀尖1360露出。当处于该位置时，例如，可采用弯曲的刀尖1360横切组织，例如半月板。在第二操作模式中，摆臂部1332处于移动中。
在图74-77所示的实施例中，采用抽吸管1350以向刀尖1360牵拉松散组织，同时在切割过程中移除被横切组织的碎片。在其他实施例中，抽吸可发生在位于护套1320、1330之间的环形空间。在其他实施例中，刀片200可具有延伸通过其中的最终与上述抽吸源连通的抽吸通道(未示出)。此抽吸通道将很可能在近端的节点处退出刀片200。还有一些其他实施例中，不采用抽吸。
在一些实施例中，摆臂部1332可长久保持在对着刀片200的位置。还有一些实施例中，可将润滑的或低摩擦的垫片(未示出)容纳在摆臂部1332上，使得垫片与刀片200接触。在其他实施例中，可在摆臂部1332与刀片200之间设置0.002″-0.010″的间隙。在其他实施例中，摆臂部1332绕刀片200的弯曲部分的长度延伸，使得整个刀片200被从后侧覆盖。
上文所述的多种非限制性实施例可结合多种不同的外科应用有效地应用，并尤其适于在关节镜手术的含水环境中切割和凝固组织然而在此类应用中，如果流体在刀片或波导与内部护套之间经过，则流体可能进入外壳并损坏其中的部件。已知多种密封构造可与超声动力外科器械一起使用。例如，美国专利No.5,935,144和美国专利No.5,944,737(它们的公开内容均以引用方式全文并入本文)均公开了在传统的腹腔镜手术和开腹手术环境(即，非水性环境)中与超声外科器械一起使用的多种密封构造。然而，下文讨论的多种非限制性实施例采用可更适于用在含水环境中的改良的密封构造。
更具体地讲并结合图78，其示出了包括外壳1402的超声装置1400，该外壳可旋转地支承其中的超声换能器组件1404。例如，超声换能器组件1404可由一系列的轴承(未示出)可旋转地支承在外壳1402内。超声喇叭1406可被连接于超声换能器组件1404，并且其上附接有超声工具1410，所述附接通过通常可包括螺纹构造的常规手段实现。如本文所用，术语“超声工具”可涵盖本文所述的刀片和切割构件实施例中的任何一种。超声工具1410附接于超声喇叭1406的部分可称为波导部分1412。波导1412可构成超声工具1410的一体部分或可包括通过(例如)螺纹连接与之附接的单独部件。在图78所示的实施例中，超声工具1410延伸通过中空外部护套1420。护套1420和超声工具1410的远端可按上文所述的多种刀片和护套构造以及其他构造中的任何一种进行构造。
如在图78中可见，近侧轴1430附接于超声换能器组件1404。从动齿轮1432连接于近侧轴1430，所述从动齿轮与传动齿轮1434啮合，传动齿轮则连接于马达1440的输出轴1436。超声电信号和马达控制信号可通过上述类型和构造的滑环组件1450由控制系统10提供。装置1400还可包括上述多种控制按钮构造，使得装置可用于超声模式、非超声模式(例如，旋转剃刮模式)以及此类模式的组合。与上述多种器械不同，马达1440不与超声换能器组件同轴对齐。
图79示出了可用在超声工具1410的波导或近侧部分1412与外部护套1420之间的密封组件1470的非限制性实施例。密封件1470包括可由硅或其他材料(例如，Ultem
)制成的环形构件，其在节点“N”处包覆成型或以其他方式密封附接于波导1412上。密封件1470可具有在节点“N”处成型在波导1412上的第一环形密封部分1472以及在相对的轴向上轴向延伸超过第一环形密封部分1472并由凹槽1478分离的两个轴向密封部分1474、1476。凹槽1478可使两个轴向密封部分1474、1476能够在与外部护套1420的密封接触中相对于彼此稍微折曲。在提供密封件1470与外部护套1420接触的较宽接触面积的同时，较窄的第一环形密封部分1472可避免过量聚热。
图80示出了可用在超声工具1410的波导或近侧部分1412与外部护套1420之间的密封件1480的非限制性实施例。密封件1480包括可由硅或其他材料(例如，Ultem
)制成的环形构件，其在节点“N”处包覆成型或以其他方式密封附接于波导1412上。密封件1480可被布置为与形成在外部护套1420上的向内伸出的环形邻接环1490邻接。密封件1480相对于邻接环1490位于远侧。当流体压力在外部护套1420的远端内增强时，密封件1480被迫靠贴于邻接环1490，从而增强密封件的强度。外部护套1420可由(例如)不锈钢制成。
图81示出了可用在刀片1410的波导部分1412与外部护套1420之间的密封件1500的非限制性实施例。密封件1500包括可由硅或其他材料(例如，Ultem
)制成的环形构件，其在节点“N”处包覆成型或以其他方式密封附接于波导1412上。密封件1480可被布置为接纳在设置于外部护套1420中的环形凹槽1423内。外部护套1420可由(例如)不锈钢制成。
图82示出了可用在超声工具1410的波导或近侧部分1412与外部护套1420之间的密封件1510的非限制性实施例。密封件1510包括可由硅或其他材料(例如，Ultem
)制成的环形构件，其在节点“N”处包覆成型或以其他方式密封附接于波导1412上。密封件1510可具有在节点“N”处成型在波导1412上的内缘部分1512以及在相对的轴向上轴向延伸超过内缘部分1512并由凹槽1518分离的两个轴向密封部分1514、1516。轴向部分1514、1516的尺寸确定成可伸进设置于外部护套1420中的凹槽1520。如在图82中可见，凹槽1520具有其尺寸确定成可伸进密封件1510中的凹槽1518的向内突出的环1522。在所示的实施例中，环1522具有形成于其上的斜面1524，其允许密封件1510在组装过程中在其上滑动然后锁定就位。外部护套1420可由(例如)Ultem
制成。
图83和84示出了可用在超声工具1410的波导或近侧部分1412与外部护套1420之间的密封件1530的非限制性实施例。密封件1530包括可由硅或其他材料(例如，Ultem)制成的环形构件，其在节点“N”处包覆成型或以其他方式密封附接于波导1412上。密封件1530可具有如图83所示的在其中的凹槽1532。再有，外部护套1420形成褶皱从而挤压密封件1530，如图84所示。外部护套1420可绕整个圆周均匀地形成褶皱，或者可在离散的位置上形成褶皱。例如，可采用四个均匀间隔(例如，90度间隔)的褶皱。在此类实施例中，外部护套1420可由(例如)不锈钢制成。
图85示出了外部护套1540的一部分，其具有适于通过(例如)焊接、压力配合、螺接或扣接而互连的近侧轴向部分1542和远侧轴向部分1544。如在图85中可见，远侧轴向部分1544具有其尺寸确定成可接合环形密封件1550的一部分的凹槽部分1546，所述环形密封件在节点“N”处包覆成型或以其他方式密封安装在超声工具1410的波导或近侧部分1412上。因而，当连接在一起时，近侧轴向部分1542和远侧轴向部分1544用来在其间拦住并压缩密封件1550的一部分。在可供选择的实施例中，凹槽部分1546可设置在近侧轴向部分1542中，或每个部分1542、1544都可具有相互配合以在其中容纳环形密封件1550的凹槽部分。
图86示出了一般地标示为1560的由两个侧向半块1562、1564构成的护套的一部分。每个侧向半块1562、1564具有形成在其中的半环形凹槽部分1566。参见图87。半环形凹槽部分1566形成环形凹槽1568，其尺寸确定成可在侧向半块1562、1564接合而形成中空外部护套1560时接纳环形密封件1570，所述环形密封件以包覆成型或以其他方式附着在波导或近侧部分1412上。如果在组装过程中必须沿着外部护套1560推动波导1412，则通过构造两件式外部护套15601560，密封件1570可具有比通常大得多的对外部护套15601560的阻碍。两个护套半块1562、1564可通过焊接、按扣配合或其他合适的方法连接在一起。因而，可首先将密封件1570安装在波导1412上。其后，可将两个半块1562、1564围着波导1412合拢，使得密封件1570卡入凹槽1568内。然后，在该位置将半块1562、1564紧固在一起。
图88示出了可用在超声工具的波导部分1412与外部护套1420之间的密封件1580的非限制性实施例。密封件1580包括可由硅或其他材料(例如，Ultem
)制成的环形构件，其在节点“N”处包覆成型或以其他方式密封附接于波导或近侧部分1412上。密封件1580可通过近侧环1590和远侧环1592固定在适当的位置。近侧环1590可构成外部护套1420的一体部分或可包括压入外部护套1420或以其他方式附接于其上的单独构件。远侧环1592可被胶接、压配或以其他方式附接于外部护套1420上。远侧环1592在安装时可在密封件1580上形成压缩。这会增加密封件1580与波导1412之间的力，从而进一步减少经过密封件1580的流体移动。环1590、1592可包括有开口的环或在其中无开口的环。另外，如在图88中可见，环1590、1592的尺寸可相对于波导1412确定，使得在其间设置一定量的间隙“C”。
图89示出了可用在超声工具1410的波导或近侧部分1412与外部护套1420之间的密封件1600的非限制性实施例。密封件1600包括可由硅或其他材料(例如，Ultem
)制成的环形构件，其在节点“N”处包覆成型或以其他方式密封附接于波导1412上。密封件1600的外径可大于外部护套1420的内径。密封件1600还可具有近侧1602和远侧1604。当组装时，密封件1600的近侧1602的外面部分与外部护套1420的内壁1421密封接触。因而，当流体压力“P”在密封件1600的远侧上增加时，将进一步促使密封件1600与外部护套1420密封接触，从而在波导1412与外部护套1420之间形成更好的密封。
图90示出了可用在刀片的波导或近侧部分1412与外部护套1420之间的密封件1610的非限制性实施例。密封件1610包括可由硅或其他材料(例如，Ultem
)制成的环形构件，其被成型或以其他方式附接于外部护套1420上，如图所示。在本实施例中，可在波导1412中设置环形凹槽1620，以在其中接纳密封件1610的一部分。在可供选择的实施例中，不设置凹槽。会进一步理解到，在不脱离本文所公开的多种非限制性实施例及其相应等同物的精神和范围的情况下，图79-82所示的密封件可同样附接于外部护套而不是所示的切割刀片或工具的波导或近侧部分。另外，会进一步理解到，本文所述的多种密封件实施例可与任何上述外科器械实施例一起有效地使用。也就是说，本文所公开的多种非限制性密封件构造及其相应的等同结构可有效地用于实现超声刀片或波导与相应的内部护套之间的密封。在那些采用内部护套和外部护套但在其间不施加负压的实施例中，本文所公开的多种非限制性密封件构造及其相应的等同物还可有效地用于实现内部护套与外部护套之间充分的液密密封。在其他非限制性实施例中，密封件可用在超声刀片与外部护套之间，其中超声刀片不进行相对于外部护套的显著旋转运动。在此类实施例中，密封件可刚性地附着于超声刀片和外部护套上。在其他非限制性实施例中，超声刀片可在外部护套内摆动。例如，超声刀片可摆动通过90度的弧(中心轴线的每侧上各45度)。在此类实施例中，密封件可通过(例如)粘合剂、褶皱等方式刚性地附着于外部护套和超声刀片上。密封材料可包括能够适应±45度范围内的密封件扭转的弹性橡胶材料等。在此类实施例中，密封件经受的拉伸可以有助于使刀片返回至零度的中间位置(与中心轴线对齐)。
多种上述实施例采用了用于剪断在刀片上形成的切割刃与周围外部护套的棱边之间的组织的旋转刀片。虽然此类构造在切割大多数组织时非常有效，但却难以有效地切割诸如肌腱组织的坚韧组织，因为其往往会挤到刀片与外部护套之间。此问题类似于使用剪刀切割诸如皮革的坚韧材料时遇到的问题。简言之，剪刀片发生分离而材料却未被切割。这种现象在图91A-D中图示说明。如在那些图中可见，用两个切割刀片1700来切断坚韧的组织“T”。当刀片1700朝组织“T”向内移动时，组织“T”移入刀片1700之间并使刀片分离。
在本文所公开的多种刀片和护套实施例中，可有利的是，最小化外部护套的切割部与刀片的切割刃之间的间隙量。例如，可能理想的是，将外部护套的切割部与刀片上的切割刃之间的间隙量保持在0.001″至0.005″的范围内。在其他非限制性实施例中，一个切割刃或切割部比另一切割部更硬。例如，刀片上的切割刃可比外部护套的切割部硬，反之亦然。还有，可在使用或不使用超声的情况下启动马达，以在切割刃/切割部之间达到近乎零间隙。除了此类方法之外或作为此类方法的替代，其他实施例可能采用在外部护套内将刀片的至少远侧部分以“偏心”构造偏置而仍便于刀片在其中旋转的结构。更具体地讲并结合图92-93，示出了延伸通过外部护套组件3000的上述类型和构造的刀片200。在所示实施例中，外部护套组件3000结合可按上述任何方式构造的外科器械3001使用，以选择性地向刀片200施加显著旋转运动以及选择性地向其施加超声运动。
在图93所示的实施例中，刀片200轴向延伸通过安装在器械外壳3010的一部分内的内部护套3020。外部护套组件3000附接于器械外壳3010并具有在其中有窗口即开口3004的远侧顶端部分3002。如上所讨论，窗口3004使组织能够被抽吸到形成在远侧顶端部分3002内的顶端腔体3006中。可通过与抽吸源244连通的外部护套组件3000的远侧顶端部分3002中的抽吸口3007，将负压施加到顶端腔体3006。在这些实施例中，刀片200具有一些柔韧性并且可由(例如)钛制成。另外，刀片200的波导部分或近侧部分延伸通过安装在节点“N”位置处的内部护套3020内的衬套3030。在多种实施例中，内部护套3020可由基本上刚性的并抗弯曲的材料制成。例如，内部护套3020可由Ultem或类似材料制成。衬套3030可由(例如)Ultem
制成并通过(例如)不锈钢不可旋转地保持在内部护套3020内。
如在图92A和93中可见，刀片200的波导或近侧部分701延伸通过衬套3030中的孔3032。衬套孔3032的中心线CL-CL与外部护套3000限定的中心轴线A-A偏离(即不同轴)。衬套孔3032的尺寸相对于刀片200的近侧部分701确定，以允许近侧部分701在其中自由转动，还用来使刀片200的远端部分700偏离外部护套3000的中心轴线A-A，使得刀片200的组织切割远端705与窗开口3004限定的切割棱3005保持旋转式接触。在一些实施例中，例如，刀片200可偏离中心的距离可高达0.030″。由于将刀片200的组织切割远端705以此方式偏置，远端705能抵抗切割坚韧组织时遇到的力，否则这种力会使远端705上的切割刃706从窗开口3004的切割棱3005移开。
图94和95示出了另一个实施例，其中刀片200的近侧部分701同轴延伸通过衬套3040，其可由例如硅橡胶(silastic silicone)或Ultem
制成并通过(例如)滑动配合保持在内部护套3020内。与上述实施例一样，衬套3040可沿刀片200的波导或近侧部分并位于节点“N”处。然而，在本实施例中，远侧部分711(即，从衬套3040向远侧延伸的刀片200的部分)稍微弯曲，以将刀片200的组织切割远端705偏置到窗开口3004的切割棱3005内。例如，刀片200的远侧部分711可偏离中心弯曲大约0.030英寸(图95中的距离OS)。此构造促使刀片200的组织切割远端705抵抗切割坚韧组织时遇到的力，否则这种力会使刀片200上的切割刃706从窗开口3004的切割棱3005移开。
图96-97示出了另一个非限制性外部护套3040和刀片200的实施例。在本实施例中，采用了远侧护套顶端3050。远侧护套顶端3050可由金属(例如，不锈钢)制成并具有延伸进外部护套3060的开放远端3062的近侧轴承部分3052。外部护套3060可由(例如)不锈钢制成并可通过紧固件、粘合剂等连接于远侧护套顶端3050。外部护套3060的近端3062附接于上述器械外壳的一部分上。所述器械可包括许多上文详细描述的将显著旋转运动提供给刀片200以及向其提供超声运动的多种器械实施例。
刀片200的波导或近侧部分701可附接于超声喇叭(未示出)并按上述多种方式延伸通过内部护套3070。刀片200的近侧部分701可通过上述衬套3040可旋转地支承在内部护套3070内。刀片200的远侧部分711可旋转地延伸通过在远侧护套顶端3050中的内腔3054。参见图97。窗口3056形成在远侧护套顶端3050中以露出刀片200的组织切割远端705。与上述多种实施例一样，窗口3056可限定与刀片200的旋转组织切割远端705相互作用的至少一个切割棱3057，以切割被吸入窗口3056的组织。在本实施例中，刀片200的组织切割远端部分705的外径“OD”在刀片200的远端705向远侧突出到窗开口3056中的位置处大于内腔3054的内径“ID”。在一些实施例中，例如，内部内腔直径“ID”可为约0.140″并且刀片“OD”可为约0.150″。此构造在刀片200的组织切割远端705与远侧护套顶端3050之间造成干涉。在此构造中，刀片200的远侧部分711基本上构成悬臂梁，其引起刀片200的组织切割远端705被远侧护套顶端3050下推(图97)。
在图92-97所示的实施例中，可能理想的是，在远侧护套顶端3050的远端3058与刀片200的弯曲顶端部分702间设置一定量的间隙。该间隙“C”在图97中示出。此间隙使刀片200的超声运动能够顺畅进行。然而，可能理想的是，最小化此间隙“C”以减少弯曲顶端部分702附近的负压损失，这种损失可能妨碍所述装置的组织切割能力。
另外，为了便于将组织抽吸进窗开口3056中，必须按上述多种方式从抽吸源(未示出)将负压施加在远侧护套顶端3050内。在本实施例中，例如，在远侧护套顶端3050中设置抽吸通道3080，如图97和98所示。密封件3090套接在刀片200的远侧部分711上以在刀片200的远侧部分711退出内部护套3070的位置建立液密密封。参见图97。同样在本实施例中，内部护套2070的远端3072延伸进在远侧护套顶端3050的轴承部分3052中的开口3055，以向其提供相对的刚性支承。如在图98中可见，抽吸通道3080在由开口3055限定的内部护套支承表面3057中形成间断。图99示出了可供选择的远侧护套顶端3050’，其中抽吸通道3080’不延伸进支承内部护套3070的远端3072的开口3055’。
采用外部护套和旋转式切割构件构造的多种超声外科器械，还面临着由于在那两个部件之间的热量和大接触力而产生外部护套和刀片变形的挑战。通过将顶端材料改变成金属可减少外部护套的远侧顶端部分的变形，但是这会导致因磨损而损坏刀片的不良效果，其可最终导致刀片破坏和极其有限的刀片寿命。此护套顶端刀片磨损损坏可由于在刀片与护套顶端之间的金属间接触而发生。当切割诸如肌腱等坚韧组织时，这种状况可能加剧。如上文所讨论，此类坚韧组织可将切割刃彼此偏置并迫使刀片的相对切割刃或表面与护套顶端接触，从而导致磨损。
本文所述的多种非限制性实施例及其相应的等同物可在形成在外部护套的远侧顶端部分内的顶端腔体的内壁上使用薄的减摩擦材料，或在可供选择的实施例中，可将低摩擦或减摩擦垫片固定在顶端腔体内以保护刀片。一个示例性实施例在图100和101中示出。如在那些图中可见，上述外部护套900’中具有减摩擦聚合物涂层或垫片3100。在多种实施例中，外部护套900’的远侧顶端部分902’可由金属(例如不锈钢)制成，并且减摩擦材料或垫片3100可由(例如)聚酰亚胺、碳填充聚酰亚胺、Teflon
、Teflon-陶瓷等制成。在使用垫片的那些实施例中，垫片可通过(例如)粘合剂或燕尾榫构造固定在顶端部分902’内。垫片3100优选地能够匹配刀片的相应几何形状。例如，如图101所示，可能基本上类似于上述刀片200的刀片3110具有远端部分3112，该远端部分具有分离两个切割面3116、3118的中部3114。切割面3116、3118具有弓形形状并具有形成在其每个边缘上的切割刃3120。在该实施例中，聚合物垫片3100也具有类似弓状成形的上表面3101。此概念的优点在于其保持了利于切割坚韧组织的硬质金属切割刃(例如不锈钢)。当垫片3100由能够以另外的方式支承施加到刀片上的力的较软材料制成时，该垫片还可保护刀片200的宽切割面3116、3118。另外的或可供选择的方式是，顶端部分902’的内壁903’可涂覆上述类型的减摩擦涂层3130。涂层3130可包括通过粘合剂固定在适当位置的单独构件或可包括直接粘附到顶端部分902’的内表面903’的沉积涂层。例如，可通过气相沉积将Teflon
材料施加到内壁903’的某些部分上。在将顶端902’暴露于气相沉积过程之前，用已知的遮蔽技术遮蔽无需涂层的顶端902’的部分。
图102示出了可涂覆相对硬的低摩擦材料以增加表面硬度和减少摩擦的组织切割刀片末端3112’。具体地讲，如在该图中可见，切割面3116’、3118’的至少某些部分涂覆有涂层材料3130。在一些实施例中，例如，涂层材料可包括诸如氮化钛、类金刚石涂层、氮化铬、Graphit iCTM等的涂层材料。刀片3060’可结合由金属(例如不锈钢)制成的护套顶端使用，以避免刀片磨损和可能发生的刀片损坏。在可供选择的实施例中，刀片的整个远侧组织切割末端均可涂覆有涂层材料3130。
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，或者在即将施行手术操作前由手术队组装。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。
在所并入的材料与现有定义、陈述或本公开所述的其他公开材料不产生冲突的范围内，本说明书中提及的所有上述美国专利和美国专利申请以及已公布的美国专利申请均以引用方式全文并入本文。同样地并且在必要的程度下，本文明确阐述的公开内容取代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：
外壳；
支撑在所述外壳内的超声换能器组件；
连接到所述超声换能器组件的刀片；
连接到所述外壳并且在所述刀片的一部分周围轴向延伸的中空护套；以及
用于在所述刀片的一部分与所述中空护套之间形成密封的密封组件，所述密封组件包括：
连接到所述刀片的第一环形密封部分；以及
两个轴向密封部分，所述两个轴向密封部分自所述第一环形密封部分在相对的轴向上轴向延伸超过所述第一环形密封部分并且与所述中空护套内壁的相应部分柔性密封接触。
2.根据权利要求1所述的超声外科器械，还包括所述两个轴向密封部分之间的环形凹槽。
3.根据权利要求2所述的超声外科器械，其中所述中空护套的一部分延伸到所述环形凹槽内。
4.根据权利要求2所述的超声外科器械，其中所述两个轴向密封部分延伸到在所述中空护套中形成的相应环形护套凹槽内。
5.根据权利要求4所述的超声外科器械，还包括所述护套凹槽中的向内突出的环部分，所述向内突出的环部分具有形成于其上的斜侧部，以用于在将所述刀片安装到所述中空护套内的过程中与所述轴向密封部分中的至少一个滑动接合。
6.根据权利要求1所述的超声外科器械，其中所述第一环形密封部分在所述刀片中的节点处连接到所述刀片。
7.一种超声外科器械，包括：
外壳；
支撑在所述外壳内的超声换能器组件；
连接到所述超声换能器组件的刀片；
所述刀片的一部分上的环形密封件；以及
中空护套，所述中空护套包括：
第一护套段；以及
第二护套段，所述第二护套段能够连接到所述第一护套段，以形成用于在其中接纳所述刀片的所述部分的大致中空内腔，所述第一护套段和所述第二护套段相对于彼此构造，以在所述中空管内形成环形凹槽，用于在将所述第一护套段和所述第二护套段连接在一起并且在所述中空内腔内接纳所述刀片的所述部分时，在所述环形凹槽中密封接纳所述环形密封件。
8.根据权利要求7所述的超声外科器械，其中所述第一护套段包括近侧中空管段，并且其中所述第二护套段包括远侧中空管段，其能够用于连接到所述近侧中空护套段的远端。
9.根据权利要求7所述的超声外科器械，其中所述第一护套段包括第一细长护套半块，并且其中所述第二护套段包括第二细长护套半块，其能够用于连接到所述第一细长护套半块。
10.根据权利要求7所述的超声外科器械，其中所述第一护套段通过紧固件配置连接到所述第二护套段，所述紧固件配置选自由焊接、粘结剂、卡扣结构、压力配合配置和螺纹连接配置组成的紧固件配置组。
11.一种超声外科器械，包括：
外壳；
支撑在所述外壳内的超声换能器组件；
连接到所述超声换能器组件的刀片；
连接到所述外壳并且在所述刀片的一部分周围轴向延伸的中空护套；以及
用于在所述刀片的一部分与所述中空护套之间形成密封的密封组件，所述密封组件包括：
连接到所述刀片的环形密封件；以及
邻近所述环形密封件近端的从所述中空护套的内壁突出的第一环形环构件。
12.根据权利要求11所述的超声外科器械，其中所述第一环形环构件与所述中空护套一体地形成。
13.根据权利要求11所述的超声外科器械，还包括邻近所述环形密封件远端的从所述中空护套的内壁突出的第二环形环构件。
14.根据权利要求13所述的超声外科器械，其中所述环形密封件被压缩在所述第一环形环构件与所述第二环形环构件之间。
15.根据权利要求13所述的超声外科器械，其中所述第一环形环构件和所述第二环形环构件中的至少一个包括压入所述中空护套内的开口环。
16.根据权利要求13所述的超声外科器械，还包括：当所述刀片被接纳在所述中空护套内并且所述环形密封件被捕获在所述第一环形环构件与所述第二环形环构件之间时，所述第一环形环构件和所述第二环形环构件中的每一个与所述刀片之间的环形间隙量。
17.一种超声外科器械，包括：
外壳；
支撑在所述外壳内的超声换能器组件；
连接到所述超声换能器组件的刀片；
连接到所述外壳并且在所述刀片的一部分周围轴向延伸的中空护套；以及
连接到所述刀片的一部分的环形密封件，所述环形密封件的外径大于所述中空护套的内径，所述环形密封件具有近侧和远侧，使得当所述刀片的所述部分安装在所述中空护套内时，所述近侧的一部分与所述中空护套的内壁密封接合。
18.一种在超声外科器械的切割构件与所述器械的中空护套之间形成基本上的流体密封的方法，所述方法包括：
在所述切割构件上安装密封件，其中所述密封件具有在其中的环形凹槽；以及
使所述中空护套的一部分形成在所述密封件中的所述环形凹槽内。
19.根据权利要求18所述的方法，其中所述形成包括使所述中空护套的一部分卷曲到所述密封件中的所述环形凹槽内。
20.根据权利要求19所述的方法，其中所述卷曲包括在离散环形位置上将所述中空护套的所述部分卷曲到所述密封件中的环形凹槽内。
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| PCT/US2011/024190 WO2011100321A2 (en) | 2010-02-11 | 2011-02-09 | Seal arrangements for ultrasonically powered surgical instruments |
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2011
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- 2011-02-09 EP EP11706978.1A patent/EP2533712B1/en active Active
- 2011-02-09 JP JP2012552949A patent/JP5813668B2/ja active Active
- 2011-02-09 CA CA 2788685 patent/CA2788685A1/en not_active Abandoned
- 2011-02-09 WO PCT/US2011/024190 patent/WO2011100321A2/en active Application Filing
- 2011-02-09 CN CN201180018463.5A patent/CN102843982B/zh not_active Expired - Fee Related
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2015
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| CN107205763B (zh) * | 2015-07-23 | 2020-11-10 | 奥林巴斯株式会社 | 超声波处置器具和超声波处置组件 |
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| CN110662496A (zh) * | 2017-05-22 | 2020-01-07 | 爱惜康有限责任公司 | 具有带远侧重叠注塑构件的超声波导的组合超声和电外科器械 |
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| CN102843982B (zh) | 2015-11-25 |
| WO2011100321A3 (en) | 2011-11-10 |
| US20150250495A1 (en) | 2015-09-10 |
| EP2533712A2 (en) | 2012-12-19 |
| BR112012020115A2 (pt) | 2018-07-17 |
| EP2533712B1 (en) | 2017-11-01 |
| AU2011215909B2 (en) | 2015-07-09 |
| BR112012020115B1 (pt) | 2020-06-02 |
| US11369402B2 (en) | 2022-06-28 |
| CA2788685A1 (en) | 2011-08-18 |
| JP2013519436A (ja) | 2013-05-30 |
| US9649126B2 (en) | 2017-05-16 |
| US20150123348A1 (en) | 2015-05-07 |
| WO2011100321A2 (en) | 2011-08-18 |
| US8951272B2 (en) | 2015-02-10 |
| US10117667B2 (en) | 2018-11-06 |
| US20110196398A1 (en) | 2011-08-11 |
| US20190053822A1 (en) | 2019-02-21 |
| JP5813668B2 (ja) | 2015-11-17 |
| AU2011215909A1 (en) | 2012-08-23 |
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