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具有局部旋转刀和固定垫结构的超声外科器械

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CN102843981B
CN102843981B CN 201180018460 CN201180018460A CN102843981B CN 102843981 B CN102843981 B CN 102843981B CN 201180018460 CN201180018460 CN 201180018460 CN 201180018460 A CN201180018460 A CN 201180018460A CN 102843981 B CN102843981 B CN 102843981B
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fixed
surgical
arrangement
instruments
pad
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CN 201180018460
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CN102843981A (zh )
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G·C·罗伯特森
R·W·蒂姆
C·T·戴维斯
D·J·穆莫
J·R·摩根
M·C·米勒
W·D·丹纳赫
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伊西康内外科公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0266Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320016Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • A61B2017/320028Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments with reciprocating movements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320783Atherectomy 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
    • A61B2017/320791Atherectomy 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 with cutter extending outside the cutting window

Abstract

本发明提供了一种超声外科器械,所述超声外科器械支撑可相对于彼此选择性地转动的超声激活刀和外护套,以使所述刀的远侧切割顶端与在所述外护套的远端上形成的至少一个切割表面接触。在一些实施例中,所述远侧切割顶端可与位于所述外护套中开口的相对侧上的两个切割表面接触,所述远侧切割顶端突出于所述开口。组织垫可与所述切割表面连接。多种实施例还包括至少一个抽吸内腔。

Description

具有局部旋转刀和固定垫结构的超声外科器械

[0001] 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。

[0002] 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 器组成。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锐利边缘切割组 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公开了一种包括用于以剪切动作切割材 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。

[0003] 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,以切割进入外部构件中的小孔的组织。

[0004] 授予Wuchinich等人的美国专利No. 4, 922, 902公开了一种利用超声抽吸器进行 内窥镜式组织移除的方法和设备。该装置使用超声探针,该探针将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公开了另一种具有探针的超声器械,该探针具有屏蔽层, 以缩小从探针顶端发出的超声能量束。在一个实施例中,该屏蔽层延伸过探针的自由端以 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。可将聚焦表面倾斜、弯曲或小平面化。授予michinich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,所述系统 通过使用纵向扭转谐振器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。

[0005] 需要提供一种可在关节镜式环境中快速地和止血地切割和移除组织的外科器械。

[0006] 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

[0007] 在一个大体方面,多种实施例涉及一种包括用于支撑外护套的外壳的超声外科器 械。外护套中可具有远侧刀开口,该开口限定至少一个切割表面。外护套还可具有至少一 个穿过其中的抽吸内腔,该抽吸内腔与远侧刀开口连通。超声换能器组件可由外壳支撑并 且具有与其连接的刀。刀可延伸穿过外护套使得刀的远侧顶端延伸进刀开口中。刀远侧顶 端的组织切割部分可径向地突出于刀开口。马达可由外壳支撑并且连接到超声换能器组件 和外护套之一以向其施加旋转运动,以使刀的组织切割部分与外护套上的所述至少一个切 割表面接触。

[0008] 结合本发明的另一个普遍方面,提供了一种切割组织的方法。该方法的一种形式 包括将外科器械的刀插入到患者身体中,其中刀附接到超声运动源并且延伸穿过中空外护 套,使得刀的组织切割顶端通过外护套中的刀开口而露出。刀和外护套之一可相对于另一 个选择性地转动。该方法还可包括定位刀和外护套使得刀开口邻近患者体内的目标组织, 以及通过外护套施加抽吸以将目标组织牵引到刀开口中。该方法还可包括将刀和外护套之 一相对于另一个摆动使得刀的组织切割顶端接触和捕获被牵引到位于切割顶端和外护套 上的切割表面之间的刀开口中的目标组织的一部分。

[0009] 结合本发明的另一个普遍方面,提供了一种包括支撑外护套的外壳的超声外科器 械。外护套中可具有远侧刀开口,该开口限定至少一个切割表面。超声换能器组件可由外 壳旋转地支撑。刀可连接至超声换能器组件并且延伸穿过外护套使得刀的远侧顶端延伸到 远侧刀开口中,其中其组织切割部分径向地突出于该远侧刀开口。马达可由外壳支撑并且 连接到超声换能器组件以向其施加旋转运动,以使刀的组织切割部分与所述至少一个切割 表面接触。该器械还可包括用于限制所述刀的组织切割部分在与切割表面接触时所经受的 扭转量的装置。

附图说明

[0010] 各种实施例的特征在所附权利要求书中进行了详细描述。然而,通过参考以下结 合如下附图所作的说明可最好地理解所述多个实施例(有关手术组织和方法)及其进一步 的目的和优点。

[0011] 图1是本发明的非限制性外科控制系统实施例的示意图;

[0012] 图2是本发明的非限制性手持件实施例的剖视图;

[0013] 图3是可随本发明的多种非限制性实施例一起使用的超声外科手持件的局部剖 视图;

[0014] 图4是本发明的非限制性突鼻件实施例的一部分的剖视图;

[0015] 图5是本发明的非限制性突鼻件实施例的局部分解组件视图;

[0016] 图6是刀的组织切割顶端位于一个位置的本发明的非限制性外护套和远侧护套 顶端实施例的一部分的透视图;

[0017]图7是刀位于另一个位置的图6的外护套和远侧护套顶端实施例的另一个透视 图;

[0018] 图8A是刀位于中心位置的图6和图7的外护套和刀结构的局部剖面端视图;

[0019] 图8B是刀位于组织切割位置的图8A的外护套和刀结构的另一个局部剖面端视 图;

[0020] 图8C是刀位于另一个组织切割位置的图8A和图8B的外护套和刀结构的另一个 局部剖面端视图;

[0021] 图9是本发明的另一个非限制性外护套和刀实施例的局部剖面端视图;

[0022] 图10是本发明的另一个非限制性外科器械实施例的局部侧剖视图;

[0023] 图11是本发明的另一个非限制性外科器械实施例的局部侧剖视图;

[0024] 图12是本发明的另一个非限制性外科器械实施例的局部侧剖视图;

[0025] 图13是图12的外科器械的非限制性突鼻件实施例的一部分的剖视图;

[0026] 图14是外护套位于组织切割位置的图12和图13的外科器械的外护套和刀结构 的局部剖面端视图;

[0027] 图15是外护套位于另一个组织切割位置的图12和图13的外科器械的外护套和 刀结构的另一个局部剖面端视图;

[0028] 图16是本发明的另一个非限制性外科器械实施例的局部侧剖视图;

[0029] 图17是图16的外科器械的非限制性突鼻件实施例的一部分的剖视图;

[0030] 图18是图16和图17的外科器械的外护套和刀结构的剖视图;

[0031] 图19是图18的刀和护套结构的一部分的侧视图;

[0032] 图20是图18和图19的刀和护套结构的一部分的透视图;

[0033] 图21是本发明的非限制性组织垫实施例的透视图;

[0034] 图22是本发明的非限制性刀实施例的侧正视图;

[0035] 图23是本发明的抽吸控制系统实施例和控制系统实施例的一部分以示意图形式 示出的图16的外科器械的一部分的剖面端视图;

[0036] 图24是刀位于第一中心位置的图23的刀和护套结构的一部分的透视图;

[0037] 图25是刀位于组织切割位置的图24的刀和护套结构的一部分的透视图;以及

[0038] 图26是刀位于另一个组织切割位置的图24和图25的刀和护套结构的一部分的 透视图。

具体实施方式

[0039] 本专利申请的所有者还拥有与本专利同一日期提交的以下美国专利申请,这些专 利申请以引用方式相应地全部并入本文:

[0040] 题为"ULTRASONICALLYPOWEREDSURGICALINSTRUMENTSWITHROTATING ⑶TTING MPLEMENT"(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._;

[0041] 题为"METHODSOFUSINGULTRASONICALLYPOWEREDSURGICALINSTRUMENTSWITH ROTATABLE⑶TTING MPLEMENTS"(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._,

[0042] 题为 "SEALARRANGEMENTSFORULTRASONICALLYPOWEREDSURGICAL 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._;

[0043] 题为 "ULTRASONICSURGICALINSTRUMENTSWITHROTATABLEBLADEANDHOLLOW SHEATH ARRANGEMENTS"(具有可旋转刀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._;

[0044] 题为"ROTATABLECUTTINGIMPLEMENTARRANGEMENTSFORULTRASONIC 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._;

[0045] 题为"DUAL PURPOSE SURGICAL INSTRUMENT FOR CUTTING 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._;

[0046]题为"OUTER SHEATH AND BLADE ARRANGEMENTS FOR ULTRASONIC SURGICAL INSTRUMENTS"(超声外科器械的外护套和刀构造)、代理人案卷号为END6695USNP/090348 的美国专利申请No._;

[0047]题为"ULTRASONIC SURGICAL INSTRUMENTS WITH MOVING CUTTING MPLEMENT"(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

[0048]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._。

[0049] 在详细说明超声外科器械的多个实施例之前,应该指出的是,示例性实施例的应 用或使用并不局限于附图和具体实施方式中示出的部件的构造和布置的细节。示例性实施 例可以单独实施,也可以与其他实施例、变更形式和修改形式结合在一起实施,并可以通过 多种方式实践或执行。此外,除非另外指明,否则本文所用的术语和表达是为了方便读者而 对示例性实施例进行描述而所选的,并非为了限制性的目的。还希望下述实施例、实施例表 达、实例中的任何一个或多个可与下述其他实施例、实施例表达和实例中的任何一个或多 个结合。

[0050] 各种实施例均涉及改进的超声外科系统和器械,其被构造为在外科手术中使组织 解剖、切割和/或凝固更有效。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。选择性使用超声能量和选择性旋转切割/凝固工具有利于多用途使用。

[0051] 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,本文关于临床医生紧握手持件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。

[0052] 图1以示意图形式示出了本发明的外科系统10的一个实施例。外科系统10可包 括超声发生器12以及超声外科器械组件100,而后者可包括"自备式的"超声器械110。如 将在下文中进一步详细地讨论,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连接至自备式的超声器械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可包括由德克萨斯奥 斯丁美国国家仪器公司(National Instruments of Austin,Texas)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。电源22可包括由美国国家仪器 公司(National Instruments)制造的电源。然而,可成功使用其他电源。电源22还可由 电缆25连接到马达驱动器26以同样向其提供24V直流电。马达驱动器26可包括由美国 国家仪器公司(National Instruments)或其他公司制造的马达驱动器。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或其他控制开关构 造可由电缆31连接到控制模块24。如将在下文中进一步详细地讨论,超声外科器械100 可包括马达190,该马达具有与其相关的编码器194。如将在下文中进一步详细地解释,马 达190可与扭转弹簧300连接,在一个实施例中,该扭转弹簧与滑环组件150连接。在一 个实施例中,马达190可包括由美国国家仪器公司(National Instruments)制造的型号 为No. CTP12ELF10MAA00的步进电机。编码器194可包括由华盛顿温哥华美国数字公司 (U.S. Digital of Vancouver,Washington)制造的型号为 No. E2-500-197-I-D-D-B 的编码 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。

[0053] 如同样可在图1中所见,在多个实施例中,马达控制系统20封装在机罩21中。为 方便系统的易携带性,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以利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插头/电缆50提供给电源22,该常规插头/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可封装在共同的护套76中。

[0054] 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整体地 形成,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(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15可与超声发生器模块13整体地形成。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可包括多个电导体以将电能施加到超声换能器组件114的正(+)和负(-)电极,如将在 下文中进一步详细地讨论。

[0055] 已知各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 Mount For Ultrasonic Surgical Instruments"(超声外科器械的旋转换能器架)的共有的美国专利申请 No. 12/503,770中有所公开,该专利申请以引用的方式全文并入本文。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 Up of an Ultrasonic System Under Zero Load Conditions"(改进超声系统在零负载条件下的启动的方法));美国 专利 No. 6, 537,291 ( "Method for Detecting a Loose Blade in a Handle Connected to an Ultrasonic Surgical System"(在连接至超声外科系统的柄部中检测松懈的刀 的方法));美国专利 No. 6, 626,926( "Method for Driving an Ultrasonic System to Improve Acquisition of Blade Resonance Frequency at Startup"(驱动超声系统 以在启动时改进对刀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/orlmpedance Information"(利用速率和 /或阻抗信息检测刀破损的方法));美国专利No. 6, 662, 127( "Method for Detecting Presence of a Blade in an Ultrasonic System"(在超声系统中检测刀的存在的方法)); 美国专利 No. 6, 678, 621 ("Output Displacement Control Using Phase Margin in an Ultrasonic 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 Transverse Vibrations 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 Altering Generator 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( "Detection Circuitry 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 Transducer Capacitance 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 an Ultrasonic System to Improve Acquisition of Blade Resonance Frequency at Startup"(驱动超声系统以在启动时改进对刀谐振频 率的获取的方法));以及美国专利 No. 7, 273, 483 ("Apparatus and Method for Alerting Generator Function in an Ultrasonic Surgical System"(在超声外科手术系统中警不 发生器功能的设备和方法))。

[0056] 如在图2中可见,超声外科器械手持件100可包括封装马达190、编码器194、滑环 组件150以及自备式的超声外科器械110的外壳102。外壳102可以两个或更多个部分提 供,它们通过紧固件(诸如螺钉、按扣结构等)连接在一起,并且可由例如聚碳酸酯、聚醚酰 亚胺(GE Ultem® )或金属(例如铝、钛或钢)制成。马达190可包括(例如)由美国国家 仪器公司(National Instruments)制造的步进电机。然而其他马达也可用于完成(例如) 自备式的超声外科器械110相对于外壳102的约l-6000rpm的"大幅度"旋转运动。编码 器194将马达轴192的机械转动转化成电脉冲,该电脉冲将速度和其他马达控制信息提供 给控制模块24。

[0057] 该自备式的超声外科器械110可包括由Ethicon Endo-Surgery (爱惜康内镜外科 公司)制造和销售的型号为No. HP054的外科器械。然而,可成功地使用其他超声器械。应 当理解,本文所用的术语"自备式的"意思是该超声外科器械除了与外科器械100 -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 撑压电超声换能器组件114的外壳112,该压电超声换能器组件用于将电能转化成机械能 以使换能器组件114的末端进行纵向振动。超声换能器组件114可包括陶瓷压电元件的 叠堆,其运动零点位于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可与圆柱体118连接,圆柱体118继而在另一个运动零 点122处安装到外壳上。喇叭件124也可在一个侧面上的零点处连接,并且可连接到另一 侧面上的耦合器126。刀200可固定到耦合器126上。因此,刀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 最大运动的电流将因器械而异,并且是存储在器械的非易失性存储器中的值,因而系统可 以使用所述电流。

[0058] 可设计超声器械110的各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124的刀200的直径减小,纵向前后运动增大。因而,可制定喇叭件124以及刀/耦 合器的形状和尺寸以便扩大刀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 刀200的声学安装喇叭件124的末端产生最大前后运动。超声换能器组件114处20至25 微米的运动可通过喇叭件124扩大为约40至100微米的刀运动。

[0059] 当通过操作脚踏开关30或其他开关构造而施加电力到超声器械110时,控制系统 20可(例如)使刀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应 用的(如通过用户可调节地选择的)驱动电力(电流)的量成比例地变化。当应用相对高 的切割电力时,可设计刀200按超声振动速率在约40至100微米的范围内纵向运动。刀 200的该超声振动将在刀接触组织时产生热量,即通过组织的刀200的加速将使运动刀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,这将 减少或消除小血管诸如直径小于一毫米的那些血管的出血。刀200的切割效率以及止血程 度将随所应用的驱动电力水平、外科医生施加给刀的切割速率或力度、组织类型的性质和 组织的血管分布而变化。

[0060] 如在图2中可见,超声器械110通过尾端件驱动衔接子130和远侧手持件衔接子 134支撑在外壳102中。尾端件驱动衔接子130通过近侧轴承132可旋转地支撑在外壳102 中并且不可旋转地连接到马达190的输出轴192上。参见图2。尾端件驱动衔接子130可 被按压在超声器械110的外壳112上。远侧手持件衔接子134可被按压在手持件外壳112 的远端113上。远侧手持件衔接子134通过安装在外壳102中的远侧轴承136可旋转地支 撑在外壳102中。

[0061] 当电力施加到马达190上时,马达190将"大幅度旋转运动"施加到手持件110上 以促使超声外科器械110和刀200绕中心轴线A-A转动。如本文所用,术语"大幅度旋转运 动"与"扭转超声运动"不同,当使用非均匀成形的超声刀时可实现该扭转超声运动。相反, 术语"大幅度旋转运动"涵盖不仅由超声换能器组件114的运行而产生的旋转运动。

[0062] 为提供动力来自超声发生器12的超声器械110,可使用滑环组件150。如图2中 可见,导体151、152连接到超声换能器组件114并延伸穿过尾端件驱动衔接子130的空心 干部分132。空心干部分132与连接到马达190的传动轴192的扭转弹簧300连接。空心 干部分132在滑环组件150中自由旋转。第一内部触点154与空心干部分132连接以随其 绕轴线A-A旋转移动。第一内部触点154设置为在滑环组件150中与固定式外部触点156 旋转接触。触点154、156可以同心排列环的形式设置。导体157、158连接到固定式外部触 点156并形成发生器电缆14。导体191和193连接至马达并形成马达电缆74,导体195、 197连接至编码器194并形成编码器电缆70。马达轴192的旋转使尾端件驱动衔接子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的旋转还引起内部触点154 的旋转。来自超声发生器12的超声信号借助内部触点154和外部触点156之间的接触或 "电连通"而被传输至内部触点154。通过导体151、152将那些信号传输至超声换能器组件 114〇

[0063] 如上指出,多种实施例使用安装在马达190的输出轴192和连接到尾端件驱动衔 接子130的远侧轴段301之间的扭转弹簧300。然而,可使用其他扭转弹簧300。如本文所 用,术语"扭转弹簧"是指沿圆形通道施加压力的那些形式的弹簧并且应与沿轴向施力的压 缩弹簧不同。下文将解释扭转弹簧300的用途。

[0064] 多种实施例还可包括远侧突鼻件160,其通过紧固件161可拆卸地连接到外壳102 的远端103。参见图5。一个或多个垫构件162可设置在远端103和突鼻件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)聚碳酸酯、聚醚酰亚 胺(GE Ultem®)或金属(例如,铝、钛或钢)制成。在多种实施例中,刀200的远端202延 伸穿过套接在内部护套密封件212中的中空耦合器段210。内部护套密封件212可用于在 耦合器段210和突鼻件160之间建立大体上流体密封和/或空气密封。同样在图4的实施 例中,内部护套220可通过(例如)螺纹连接而连接至中空耦合器段210,或中空耦合器段 210可包括内部护套220的整体部分。在一个实施例中,刀销/扭矩构件216可横向延伸穿 过刀构件200和中空耦合器段210以利于内部护套220与刀构件200 -起移动。可将一个 或多个开孔硅树脂套管214套接在刀200周围以在声学上将刀200与内部护套220隔离。 刀构件200可具有内部螺接的并适于可拆卸地接合耦合器126的螺纹部分的近端201。为 了有利于将刀200紧固到耦合器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)能够穿过其中插入到位于尾端件驱动衔接子130中的孔131中以 防止超声外科器械110和与其连接的耦合器126的转动。一旦刀200已螺纹连接到耦合器 126上,用户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/碎片由此进入外壳102。

[0065] 同样在各种实施例中,外护套230可与内部护套220和刀构件200同轴对齐并通 过(例如)焊接或其他适合的方法连接到突鼻件160的远端163上。如在图4中可见,抽 吸口 240可被连接到突鼻件160上以与中空外护套230连通。柔性管242可连接到抽吸口 240并与连接到大体上示为244的真空源的收集容器243连通。因而,外护套230形成围绕 内部护套220而延伸的抽吸通道,其始于外护套230的远侧顶端并且伸出抽吸口 240。本领 域的普通技术人员将会知道可供选择的抽吸通道也是可能的。另外,在可供选择的实施例 中,省略内部护套220。

[0066] 如在图6和图7中可见,示出了可连接到外护套230的远端231的远侧顶端部分 400。在多种实施例中,外护套230可由(例如)铝、钛、铝合金、钢、陶瓷等制成。远侧顶端 部分400可通过(例如)焊接、粘合剂等连接到外护套230的远端231上。如在图6和图 7中所示,远侧顶端部分400限定了两个切割表面402、404,所述两个切割表面在形成于其 中的刀开口 410的每一侧面上形成切板表面。

[0067] 图8示出了形成于或以其他方式设置在刀200上的一种形式的远侧组织切割顶端 250。如在该图中可见,远侧组织切割顶端250上形成有一对组织切割刃252、254。在多种 实施例中,刀250可由(例如)钛制成。在图6和图7所示的实施例中,远侧刀顶盖260可 与刀200的远侧组织切割顶端250的远端251连接。可将远侧刀顶盖260设计成具有适当 尺寸以可旋转地支撑在形成于远侧顶端部分400中的顶端腔412中,使得刀200可绕纵向 轴线A-A来回摆动(由图6和图7中的箭头"B"表示)。

[0068] 外科系统10的多种实施例提供了可选择性地将超声运动施加到刀200和将大幅 度旋转运动施加到刀200的能力。在一些实施例中,例如,纵向超声运动的频率范围可为约 (例如)30-80kHz。在优选的使用方法中,刀200可旋转地来回摆动使得组织接近于刀刃 252、254和切割表面402、404之间(图6和图7)。在多种实施例中,由(例如)聚四氟乙 烯或类似材料制成的组织垫270可通过(例如)粘合剂或其他适合的紧固件结构与切割表 面402、404连接。因而,组织可接近于刀刃252、254和切割表面402、404或组织垫270之 间。在使用中,刀200和组织均可立即停止以使刀将力施加到组织上,并且垫270在相对侧 面上提供"切板"表面。在多种实施例中,超声驱动刀200可随组织上所需的压力和时间量 而作动。从而,可编程控制系统的计算机处理器40以在刀200捕获垫270上的组织经过一 段预定驻留时间后使马达190停止。这将增加递送到组织的能量,因而潜在地提高了切割 速度或止血效果。在多种实施例中,例如,可成功地使用在5毫秒至10秒范围内的驻留时 间。在捕获组织之前或紧接着组织在刀刃252、254和组织垫270之间被捕获之后,可激活 超声换能器组件114以将超声运动提供至刀。

[0069] 在切割过程中,可通过抽吸源244将抽吸施加到外护套230中使得组织被牵引进 刀开口 410。如图8A-8C所示,当刀200位于图8A所示的中心位置时,可将组织"T"、"T'" 牵引进刀开口 410的两侧410R、410L中。当刀200摆动以将组织"T"捕获在刀刃252和组 织垫270之间并且在该切割位置保持预定量的驻留时间时,此驻留时间允许其他组织"T' " 被牵引进如图8B所示的刀开口 410的部分410L中。相似地,当刀200摆动以将组织"T'" 捕获在刀刃254和组织垫270之间并且在该位置保持预定驻留时间时,其他组织"T"可被 牵引进刀开口 410的部分410R中。据信使用旋转刀以切割被牵引进护套开口中的组织的 其他装置在组织正被牵引进开口中时趋于将组织"驱出"。本发明的多种实施例的摆动刀 据信比连续转动的刀更快地切割组织,因为当刀停止时有时间将组织牵引进开口的相对侧 中,从而当刀在切割时使组织不太可能"驱出"。

[0070] 本发明提供的另一个独特和新颖的优点是控制在刀/垫界面处产生的力度的能 力。例如,上述的实施例使用扭转弹簧与步进电机和编码器相结合以控制施加到刀/垫界 面上的力度。通过控制经过刀/垫接触点的马达的转动而引起扭转弹簧以某一角度发生位 移或"装载",这使得预定大小的扭转力被施加到刀上。例如,力=[扭转弹簧比率]X [角 度偏移]/[从旋转中心到刀刃的距离]。因此,在一些非限制性实施例中,例如,优选的力在 1. 5至5镑的范围内。在可供选择的实施例中,马达190可包括伺服马达并且可结合适当编 码器使用。在另一个实施例中,可省略扭转弹簧并且马达输出转轴192可直接与尾端件驱 动衔接子130连接。在这些实施例中,马达190包括基于所用的电流产生所需扭矩量的伺 服马达。在另一个实施例中,控制系统将测量马达电路中的阻抗量以控制摆动速度。当致 力于切割组织时,马达将牵引高负荷。因而,在本实施例中,当负荷超过预定阈值时,马达将 减速以使超声刀切开组织。

[0071] 图9示出了可供选择的刀实施例200'。如在该图中可见,刀200'具有由一对钝的 组织切割刃252'、254'形成的远侧顶端250'。

[0072] 图10示出了使用手持件502的本发明的另一个外科器械实施例500。在该实施例 中,手持件502包括封装连接到超声喇叭件324的换能器组件530的外壳302。超声喇叭件 324可通过螺接或其他适合的连接与刀200的近端201连接。超声喇叭件324可通过远侧 轴承336可旋转地支撑在外壳302中。突鼻件160可以上述方式连接到外壳302。

[0073] 该实施例包括马达510,该马达可包括上述类型和构造的步进电机并且可具有与 之相关的通过上述电缆70与控制模块24(图1)连通的编码器部分194。马达510可通过 导体511、512接收来自马达驱动器26(图1)的动力,所述导体包括延伸穿过共用护套76 的马达电缆74。马达510具有可通过第一近侧轴承521可旋转地支撑在外壳302中的输出 转轴520。输出转轴可与扭转弹簧540连接。扭矩弹簧540与可通过第二近侧轴承551可 旋转地支撑在外壳302中的中空传动轴段550连接。传动轴段550的远侧部552延伸穿过 滑环组件150。滑环组件150固定(即,不可转动)在外壳302内,并包括连接到构成上述 发生器电缆14 (图1)的导体157、158的固定式外部触点156。内部触点154安装在中空传 动轴段550上并且与外部触点156电接触或连通。导体151、152与内部触点154连接并且 延伸穿过中空传动轴520而与超声换能器组件530连接。

[0074] 该实施例还使用可具有与其上述远端231连接的远侧顶端部分400的外护套230。 刀可具有上述的远侧组织切割顶端250。当将电力提供到马达510时,传动轴520绕轴线 A-A旋转,这也促使换能器组件530绕轴线A-A旋转。因为刀200与喇叭件324连接,所以 它也随超声换能器组件530 -起转动。如上所讨论,结合步进电机510和编码器190,扭转 弹簧540控制施加到刀/垫界面的力度(即,当与切割表面/垫接触时,刀的组织切割部分 经受的扭转量)。

[0075] 当临床医生想要提供电力给超声换能器组件530时,电力从超声发生器12 (图1) 提供给滑环组件150中的固定式触点156。电力借助内部触点154和外部触点156之间的 旋转滑动接触或电连通被传输至超声换能器组件530。通过导体151、152将那些信号传输 至超声换能器组件530。可通过抽吸口 240将抽吸施加在刀200和外护套230之间。收集 容器243和抽吸源244可通过管242连接到抽吸口 240。刀远端通过外护套230的远端中 的窗口露出以将刀200的远侧组织切割顶端250露出给上述组织。因而,该实施例可以与 上述超声外科器械组件100相同的方式运行。

[0076] 图11示出了在设计和操作上与上述器械500基本上类似的可供选择的外科器 械实施例500',不同的是该实施例使用扭转载荷传感器560代替扭转弹簧540和编码 器194。例如,可使用由加利福尼亚州尔湾市(Irvine,California)的Futek Advanced Technologies制造的型号为No. TRD300的该类型扭转载荷传感器以及其他扭转载荷传感 器。如在图11中可见,例如,扭转载荷传感器560可与马达510的输出转轴520以及中空 传动轴段550连接。扭转载荷传感器560可以已知方式通过导体561、562与计算机处理器 40连通以使临床医生能够基于扭转载荷传感器560测得的扭矩量控制马达510。因而,临 床医生可预定要施加到刀200的所需扭矩量,然后编程该计算机处理器以将适当的马达控 制信号提供给马达以保持该扭矩水平。

[0077] 图12和图13示出了使用手持件601的本发明的另一外科器械实施例600。在该 实施例中,外科器械600包括手持件601,该手持件包括封装连接到超声喇叭件606的换能 器组件604的外壳602。超声喇叭件606可通过螺接或其他适合的连接与刀200的近端201 连接。在其他实施例中,刀200可与喇叭件606整体地形成。超声换能器组件604和超声 喇叭件606不可旋转地安装在外壳602中。

[0078] 该实施例包括马达610,该马达可包括上述类型和构造的步进电机并且可具有与 之相关的以上述方式通过导体614、616与控制模块24连通的编码器部分612。马达610可 通过延伸穿过共用护套76的导体618、620接收来自马达驱动器26的动力。马达610不可 旋转地支撑在外壳602中并且具有输出转轴630,该输出转轴上具有第一传动齿轮632。第 一传动齿轮632与安装在护套传动轴634上的第二齿轮636啮合。护套传动轴634可支撑 在多种轴承结构中以在外壳602中转动。在图12和图13所示的实施例中,护套传动轴634 可转动地支撑在近侧轴承640和远侧轴承642 (图13)中。第三传动齿轮650与护套传动 轴634的远端连接。第三传动齿轮650与安装在外护套660的近端部分662上的护套齿轮 652啮合,该外护套绕刀200可旋转地延伸并且基本上与其共延。如在图12中可见,外护套 660的近端662上可形成有凸缘664,凸缘664可旋转地容纳在鞍形部分670中,该鞍形部 分通过协同外壳602上的支脚672而形成。此结构在使外护套660绕轴线A-A旋转时防止 外护套660相对于外壳602轴向移动。

[0079] 该实施例还使用有些类似于上述突鼻件结构的突鼻件680。突鼻件680可通过螺 钉681或其他适合的紧固件结构可拆卸地连接到外壳602上。在本实施例中,外护套660可 旋转地延伸穿过突鼻件680中的通道682。近侧密封件684和远侧密封件686在建立其间 的流体密封时可旋转地支撑通道682中的外护套660。参见图13。抽吸口 240可设置在突 鼻件690中并且通过柔性管242与收集容器243连通,收集容器243连接至大体上被示为 244的真空源。将外护套660设计为相对于刀200具有适当尺寸,以在外护套660和刀200 间形成抽吸通道690。至少一个抽吸开口 664穿过外护套660设置在抽吸口 240的位置使 得当外护套通过将在下文中进一步详细讨论的预定范围的弓形运动而可旋转地摆动时,抽 吸开口 664使得通过通道690被牵引到外护套660和刀200之间的组织碎片能够通过开口 664和抽吸口 240退出抽吸通道690至收集容器243中。内部密封件668也设置在刀200 和旋转外护套660之间接近所示的抽吸开口 664的位置。

[0080] 该实施例也可使用上述类型和构造的远侧顶端部分400和上述的在图8和图9中 所示的远侧切割顶端构型250、250'。然而,在该实施例中,刀顶端250、250'是固定的并且 远侧顶端部分400 (和外护套660)可旋转地前后摆动以切割在刀刃252、254之间的组织 "T"、"T' "。参照图14和图15。外护套660可通过控制马达610的启动以任何上述的多种 形式可旋转地摆动。正如上述实施例,外护套660可旋转地摆动至一个切割位置并且在该 位置保持预定驻留时间。在该驻留时间期间,可将其他组织牵引到刀开口的相对侧中。在 驻留时间期满之后,刀可旋转地摆动至刀开口的另一侧以在类似驻留时间等期间切割所述 其他组织。

[0081] 当临床医生想要提供电力给超声换能器组件530时,电力从超声发生器12 (图1) 提供给滑环组件150中的固定式触点156。电力借助内部触点154和外部触点156之间的 旋转滑动接触或电连通而被传输至超声换能器组件530。通过导体151、152将这些信号传 输至超声换能器组件530。可通过抽吸口 240将抽吸施加在刀200和外护套230之间。收 集容器243和抽吸源244可通过管242连接到抽吸口 240。刀远端通过在外护套230的远 端中的窗口露出以将刀200的远侧组织切割顶端250露出给上述组织。因而,该实施例可 以与上述超声外科器械组件100相同的方式运行。

[0082] 图16-26示出了本发明的另一外科器械实施例700。该实施例可使用上述类型和 构造的手持件502以及采用上述可旋转摆动刀的任何变型。在其他可供选择的实施例中, 还可使用在先前已以引用的方式并入本文的下述的共同拥有的美国专利申请中公开的那 些适合的手持件。

[0083] 在多种实施例中,刀200的远端202可延伸穿过套接在内部护套密封件212中的 中空耦合器段210。参见图17。内部护套220可通过(例如)压力配合、钎焊、焊接、环氧 树脂、螺纹等连接到中空耦合器段210上,或中空耦合器段210可包括内部护套220的整体 部分。在一个实施例中,刀销/扭矩构件216可横向延伸穿过刀构件200和中空耦合器段 210以利于内部护套220与刀构件200 -起移动。可将一个或多个开孔硅树脂套管214套 接在刀200周围以在声学上将刀200与内部护套220隔离。刀构件200可具有以上述的多 种方式内部螺接和能够可拆卸地接合耦合器126的螺纹部分的近端201。在可供选择的实 施例中,刀的近端201可直接连接到超声喇叭件324或它可包括其整体部分。

[0084] 本实施例可使用固定在突鼻件160上的外护套710。在多种实施例中,外护套710 可由(例如)共挤出的聚酸亚胺或轧制焊接金属制成,并且通过(例如)焊接、粘合剂等连 接到突鼻件160。外护套710可由主内腔712和两个垫内腔714、716构成,如图18中所示。 如在图19和图20中可见,外护套710的远端750具有钝端752和与刀200延伸穿过的主 内腔712连通的刀开口 754。第一垫内腔714由第一垫凸缘713限定并且第二垫内腔716 由第二垫凸缘715限定,如图18所示。第一垫凸缘713和第二垫凸缘715相对于彼此以角 度"A"取向,如图18所示。在所示的实施例中,角度"A"为大约135度。如将在下文中所 讨论,角度"A"限定了刀200可在其中移动的弓形通道。在其他实施例中,角度"A"可具有 不同大小。

[0085] 如在图20中可见,第一组织垫760可与第一垫凸缘713连接并且第二组织垫770 可与第二垫凸缘715连接。在多种实施例中,组织垫760、770可由(例如)聚四氟乙烯或 类似材料制成,并且具有在其上形成的锯齿状的组织夹持表面762、772。在可供选择的实施 例中,组织表面762、772可为平的。垫760、770可通过(例如)过盈配合、粘合剂或机械紧 固件分别与垫表面713、715连接。垫760可具有穿过其中的与相应的第一抽吸孔717连通 的至少一个真空口 764,该第一抽吸孔延伸穿过第一垫表面713并且进入到第一垫内腔714 中。同样,第二组织垫770可具有穿过其中的与相应的第二抽吸孔719连通的至少一个真 空口 774,该第二抽吸孔延伸穿过第二垫表面715并且进入到第二垫内腔716中。真空口 764、774可具有任何适合的几何形状,例如孔形、星形、矩形狭缝、加号形等。

[0086] 如在图22中可见,刀200具有可以上述的多种方式连接到耦合器126的近端201。 在可供选择的实施例中,刀200可与超声喇叭件整体地形成。刀200还具有形成于其上的 弓形组织切割部分780。可使用其他刀构型。在多种实施例中,刀200可由(例如)钛、黄 铜、铝或不锈钢制成。

[0087] 如在图17和23中可见,第一抽吸口 790可与突鼻件160连接并且与抽吸控制系 统850 (图23)连通,如将在下文中进一步解释。第一抽吸口 790可与主内腔712连通以通 过连接到收集系统850中的第一收集线路852的柔性管或软管792从主内腔排出组织和流 体。第二抽吸口 800可与突鼻件160连接并且与抽吸控制系统850连通。第二抽吸口 800 可与第一垫内腔714连通以向其提供抽吸。第二抽吸口 800通过第二柔性管或软管802与 收集系统850中的第二收集线路854连通。第三抽吸口 810可与突鼻件160连接并且与抽 吸控制系统850连通。第三抽吸口 810可与第二垫内腔716连通以向其提供抽吸。第二抽 吸口 810通过第三柔性管或软管812与收集系统850中的第三收集线路856连通。

[0088] 如在图23中进一步可见,第一控制阀858连接在第一收集线路854和与抽吸源 890连接的收集容器880之间。第一控制阀858可通过第一导体860与控制系统中的计算 机控制器40连通。第二控制阀862连接在第二收集线路854和收集容器880之间并且通 过导体864与计算机控制器40连通。第三控制阀868连接在第三收集线路856和收集容 器880之间并且通过导体870与计算机控制器40连通。

[0089] 图24-26示出了器械700的一种使用方法。为了开始使用该装置,将外护套710 的远端插入患者体腔内并且将刀200的组织切割部分780定位在窗口开口 754的中心,如 图24所示。其后,临床医生可通过使用脚踏开关(图1)或其他开关机构激活超声换能器 组件530(图16)。临床医生也可用在打开位置的全部三个控制阀858、862、868激活抽吸源 以将抽吸施加到主内腔712和第一和第二垫内腔714、716上。然而,在一个优选的实施例 中,一次只打开用于垫内腔714、716的控制阀862、868之一,如将在下文中进一步讨论。然 后,临床医生可使外护套710的远端750与目标组织接触以使得目标组织被牵引到组织垫 760、770之一者或两者上。组织原纤将由真空通过抽吸口 764、774在组织垫760、770上固 定就位。然后,临床医生可激活马达510 (图16)以转动刀200使得其组织切割部分780转 动到组织垫760、770之一上的组织上。图25示出了转动到邻近第二组织垫770的位置的 组织切割部分780,并且省去了组织以便清晰可见。控制系统10自动地或临床医生可手动 地将在该位置的组织切割部分780保留预定驻留时间以确保横切原纤/组织。驻留时间可 为(例如)大约三(3)秒。然而,其他驻留时间可被采用并且可取决于要横切的组织类型。

[0090] 一旦驻留时间期满,则停止对接触刀200的组织切割部分780的垫内腔的抽吸。 在图25所示的实例中,将控制阀868移动至排放位置,其中抽吸线路812以及垫内腔716 通向大气。这可通过控制系统10或连接到控制阀868的手动开关(未示出)自动地完成。 然后,组织切割部分780可通过激活马达510回到图24所示的中心位置。这可通过控制系 统10或临床医生手动激活手动开关(未示出)自动地完成。将刀200的组织切割部分780 转动到中心位置并且停止对垫内腔716的抽吸将使保留在组织垫770上的任何组织碎片通 过主内腔712被抽吸。控制系统可将刀顶端780在中心位置保留第二预定驻留时间,从而 为通过主内腔712、线路792、线路852、阀858排出并且进入到收集容器880中的组织碎片 提供时间。其后,一旦第二驻留时间期满,则控制系统可打开控制阀862以将抽吸施加到垫 内腔714上。在其他实施例中,一旦临床医生观察到垫770不含组织碎片,那么临床医生可 通过手动地激活开关(未示出)而打开控制阀862。

[0091] 当将抽吸施加到垫内腔714上时,组织将被牵引到垫760上。然后,组织切割顶端 780可转动到垫760上的组织上,如图26所示。控制系统10自动地或临床医生可手动地将 组织切割部分780在该位置保留第三预定驻留时间以确保横切原纤/组织。第三驻留时间 可为(例如)大约三(3)秒。然而,可采用其他第三驻留时间并且其可取决于要横切的组 织类型。

[0092] -旦第三驻留时间期满,则停止对垫内腔760的抽吸。这可通过将控制阀862移 动至排放位置而完成,其中抽吸线路802以及垫内腔714具有通向大气的孔。这可通过控 制系统10或连接到控制阀862的手动开关(未示出)自动地完成。然后,刀200的组织切 割部分780可通过激活马达510回到图24所示的中心位置。这可通过控制系统10或通过 临床医生手动激活手动开关(未示出)自动地完成。将刀200的组织切割部分780转动到 中心位置并且停止对垫内腔714的抽吸将使保留在组织垫760上的任何组织碎片通过主内 腔712抽吸。控制系统可将刀顶端780在中心位置保留第二预定驻留时间,从而为通过主 内腔712、线路792、线路852、阀858排出并且进入到收集容器880中的组织碎片提供时间。 其后,一旦该驻留时间期满,则控制系统可重复上述过程直到已横切所需组织量为止。

[0093] 在多种实施例中,刀200快速地来回转动(例如,每分钟二十(20)转(RPM's))以 达到相当于当使用现有机械系统时通常所达到的切割速度。另外,然而本发明的多种实施 例提供额外的止血的优点。例如,如果遇到易出血者,刀200的组织切割顶端780在被激活 时(即,从换能器组件530接收超声运动)可被固定地保持在窗口 754的中心并且随后被 施加到易出血者上以促进止血。刀顶端780可摩擦易出血者的区域并且使组织脱落。

[0094] 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件以及随后组装。 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件或 零件。清洗和/或置换某些零件后,该装置可以在重新恢复设施处重新组装以供随后使用, 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。

[0095] 优选地,在外科手术前处理本文所述的各种实施例。首先,获取新的或用过的器 械,并在必要时对器械进行清洁。然后对器械进行消毒。在一种消毒技术中,将该器械置于 闭合并密封的容器中,例如塑料或TYVEK袋中。然后将容器和器械置于可穿透该容器的辐 射区,例如y辐射、X-射线或高能电子。辐射将器械上和容器中的细菌杀死。然后将灭菌 后的器械存储在消毒容器中。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 为止。消毒也可通过本领域技术人员已知的任何种方式进行,包括e辐射或Y辐射、环氧 乙烷和/或蒸汽消毒。

[0096] 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,而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。

[0097] 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。

[0098] 在本说明书中涉及的所有上述的美国专利和美国专利申请以及出版的美国专利 申请均以引用的方式全文并入本文,但仅在所并入材料与本文所述的现有定义、陈述或其 他公开材料不冲突的程度下才将其并入本文。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 (17)

1. 一种超声外科器械,包括: 外壳; 由所述外壳支撑并且从所述外壳突出的外护套,所述外护套中具有限定至少一个切割 表面的远侧刀开口,所述外护套具有穿过其中并且与所述远侧刀开口连通的至少一个抽吸 内腔; 由所述外壳支撑的超声换能器组件; 刀,所述刀与所述超声换能器组件连接并且延伸穿过所述外护套使得所述刀的远侧顶 端延伸到所述远侧刀开口中,其中所述刀的组织切割部分径向地突出所述远侧刀开口;以 及 马达,所述马达由所述外壳支撑并且连接到所述超声换能器组件和所述外护套之一以 向其施加旋转运动,以使所述刀的所述组织切割部分与所述外护套上的所述至少一个切割 表面接触。
2. 根据权利要求1所述的超声外科器械,还包括与所述至少一个切割表面的每一个连 接的组织垫。
3. 根据权利要求2所述的超声外科器械,其中每个所述组织垫上具有组织夹持表面。
4. 根据权利要求1所述的超声外科器械,其中所述至少一个抽吸内腔包括: 延伸穿过所述外护套的主抽吸内腔;以及 垫内腔,所述垫内腔延伸穿过所述外护套并且通过所述至少一个切割表面中的相应一 者与至少一个抽吸孔连通。
5. 根据权利要求4所述的超声外科器械,还包括在所述至少一个切割表面中的所述相 应一者上的组织垫并且具有通过所述切割表面与所述至少一个抽吸孔中的相应一者连通 的另一个抽吸孔。
6. 根据权利要求1所述的超声外科器械,其中所述至少一个切割表面包括: 在所述刀开口的一个侧面上的第一切割表面;以及 在所述刀开口的另一个侧面上的第二切割表面,并且其中将旋转运动施加到所述超声 换能器和所述外护套之一上使得所述刀的所述组织切割部分与所述第一切割表面和所述 第二切割表面中的每一个接触。
7. 根据权利要求6所述的超声外科器械,还包括在所述第一切割表面和所述第二切割 表面中的每一个上的组织垫。
8. 根据权利要求6所述的超声外科器械,其中所述至少一个抽吸内腔包括: 第一垫内腔,所述第一垫内腔延伸穿过所述外护套并且通过所述第一切割表面与至少 一个第一抽吸孔连通; 第二垫内腔,所述第二垫内腔延伸穿过所述外护套并且通过所述第二切割表面与至少 一个第二抽吸孔连通;以及 主抽吸内腔,所述主抽吸内腔延伸穿过所述外护套并且与所述刀开口连通。
9. 根据权利要求8所述的超声外科器械,还包括与所述第一垫内腔和所述第二垫内腔 和所述主抽吸内腔连通的抽吸控制系统。
10. 根据权利要求9所述的超声外科器械,其中所述抽吸控制系统包括: 抽吸源; 与所述抽吸源连通的收集容器; 与所述收集容器和所述第一垫内腔连接的第一抽吸供给线路; 与所述收集容器和所述第二垫内腔连接的第二抽吸供给线路; 与所述收集容器和所述主抽吸内腔连接的主抽吸供给线路; 在所述第一抽吸供给线路中的第一阀; 在所述第二抽吸供给线路中的第二阀;以及 在所述主抽吸供给线路中的第三阀。
11. 根据权利要求1所述的超声外科器械,其中所述刀的所述远侧顶端具有弓形形状。
12. 根据权利要求6所述的超声外科器械,其中所述刀的所述组织切割部分具有与所 述第一切割表面相对应的第一组织切割刃和与所述第二切割表面相对应的第二组织切割 刃。
13. 根据权利要求12所述的超声外科器械,其中所述第一组织切割刃和所述第二组织 切割刃是钝刃。
14. 一种超声外科器械,包括: 外壳; 由所述外壳支撑并且从所述外壳突出的外护套,所述外护套中具有限定至少一个切割 表面的远侧刀开口; 由所述外壳旋转地支撑的超声换能器组件; 刀,所述刀连接到所述超声换能器组件并且延伸穿过所述外护套,使得所述刀的远侧 顶端延伸到所述刀开口中,其中所述刀的组织切割部分径向地突出所述刀开口; 马达,所述马达由所述外壳支撑并且连接到所述超声换能器组件以向其施加旋转运 动,以使所述刀的所述组织切割部分与所述至少一个切割表面接触;以及 用于限制所述刀的所述组织切割部分在与所述切割表面接触时所经历的扭转量的装 置。
15. 根据权利要求14所述的超声外科器械,其中所述用于限制的装置包括可操作地连 接到所述马达和所述超声换能器组件的扭转弹簧。
16. 根据权利要求14所述的超声外科器械,其中所述用于限制的装置包括可操作地连 接到所述马达和所述超声换能器的扭转载荷传感器。
17. 根据权利要求14所述的超声外科器械,其中所述马达包括步进马达,编码器可操 作地与所述步进马达连接。
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