CN101600393B - 用于切割和凝结的超声装置 - Google Patents

用于切割和凝结的超声装置 Download PDF

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CN101600393B
CN101600393B CN200880002258.8A CN200880002258A CN101600393B CN 101600393 B CN101600393 B CN 101600393B CN 200880002258 A CN200880002258 A CN 200880002258A CN 101600393 B CN101600393 B CN 101600393B
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ultrasonic surgical
surgical instrument
end effector
ultrasonic
external jacket
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CN101600393A (zh
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A·C·沃格勒
D·W·普赖斯
J·A·威德三世
K·M·鲁普
M·A·纽罗赫
N·I·克罗舍
S·A·伍德拉夫
S·E·艾希曼
T·A·麦克法兰
T·D·洛佩斯
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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
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • 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
    • A61B17/00234—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
    • A61B2017/00336—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means with a protective sleeve, e.g. retractable or slidable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0042—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A61B2017/2927—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft
    • A61B2017/2929—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft with a head rotatable about the longitudinal axis of the shaft
    • 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
    • A61B2017/320072—Working tips with special features, e.g. extending parts
    • A61B2017/320074—Working tips with special features, e.g. extending parts blade
    • A61B2017/320075—Working tips with special features, e.g. extending parts blade single edge blade, e.g. for cutting
    • 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
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A61B2090/309—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using white LEDs

Abstract

本发明公开了一种用于切割和凝结的超声外科器械，其能够允许选择性地设置用于切割和凝结组织的端部执行器和由器械承载的用于选择性地给端部执行器供能的能量致动开关之间的相对距离。在一种例子中，端部执行器能够改变相对于致动开关的位置，替代地，致动开关相对于端部执行器运动，更进一步，端部执行器和致动开关能够相对于彼此运动。

Description

用于切割和凝结的超声装置
相关申请的引用
本申请要求享有2007年8月28日提交的序列号为60/968357以及2007年1月16日提交的序列号为60/885086的美国临时专利申请的优先权，这两个申请都通过引用结合入本文。
技术领域
本发明总的涉及超声外科系统，更具体而言，本发明涉及一种超声装置，该装置允许医生进行诸如整形外科等精确且精细的外科手术过程所需的切割、凝结和精细解剖。
背景技术
由于超声外科器械的独特性能，这种器械在外科手术中得到了越来越广泛的应用。根据具体的器械构造和操作参数，超声外科器械可以基本上同时提供组织的切割和通过凝结止血，从而使对患者的损伤最小。切割动作通常是通过位于器械远端处的端部执行器或者刀末端来实现的，其向与端部执行器接触的组织传递超声能量。这种特性的超声器械可以被构造成用于开放式外科应用、腹腔镜或内窥镜外科手术过程(包括机器人辅助的手术)。
进行一般的整形外科过程(例如，腹部整形术、乳房再造术/缩小术和面部除皱术)涉及到患者需要较长的恢复期和发生例如血清肿和血肿的术后并发症的风险。恢复期包括在手术后另外到诊所看医生，这影响了患者的满足感并减少了医生可用于外科手术的时间。先进的能量器械(代替传统的单极电外科器械-“bovie”)能够提供更加简单的恢复经历并会缩短术后恢复期。但是，目前可用的先进的能量器械并不是特别为整形外科手术设计的。它们缺乏这种手术所要求的舒适性和多样性。
例如，目前可用的能量器械仅是固定长度的。这对于很多整形外科手术来说是一个问题，因为医生喜欢在手术开始时用短刀来进行表面作业，而在后来的手术过程中用更长的刀来更深地进入组织。在目前的器械下，要求医生在手术过程中转换器械，而这在时间上和成本上都是不允许的。
一些外科器械利用超声能量来进行精确切割和受控的凝结。超声能量利用比电外科术利用的更低的温度来进行切割和凝结。通过高频(例如，每秒钟55500次)振动，超声刀改变组织中的蛋白质的性质以形成粘性凝块。刀表面施加到组织上的压力压倒血管并允许凝块形成止血密封。切割和凝结的精确度通过医生的技术和调节能量水平、刀刃、组织牵引和刀压力来控制。
目前的一些超声外科装置采用脚踏板来为外科器械供应能量。医生在向手柄上施加压力以将组织压在刀上的同时操作脚踏板，以致动提供能量的发生器，所述能量被传递给切割刀用于切割和凝结组织。这类器械致动的致命缺陷包括在医生寻找脚踏板时会分散医生在手术部位上的注意力，脚踏板妨碍了医生在手术过程中进行运动并且在长的手术过程中医生的腿容易疲劳。
因此，需要提供一种超声外科器械，其能够克服目前的器械的一些缺陷。此处描述的超声外科器械能够克服这些缺陷。
发明内容
体现本发明原理的超声外科器械组件被构造成允许在外科手术过程中选择性地进行组织的解剖、切割、凝结和夹紧。
超声外科器械的第一实施方式的第一表现形式是：被构造成接收换能器并进一步限定纵向轴线的外壳；设置在外壳上用于由使用者的一个或者多个手指致动的第一开关，该第一开关还电连接到发生器上，用于向发生器提供电信号，以控制由换能器传输的超声能量的第一水平。
超声外科器械的第一实施方式的第二表现形式是：设置在外壳上由使用者的一个或者多个手指致动的第二开关，该第二开关还电连接到发生器上，用于向发生器提供电信号，以控制由换能器传输的超声能量的第二水平。
超声外科器械的第二实施方式的第一表现形式是：沿外壳的纵向轴线延伸并被构造用于沿着该纵向轴线移动或者伸缩的刀。该部件允许使用者具有一个器械，但却具有多个刀长度。调节致动按钮相对于刀的远端的距离并由此在短刀位置提供精确控制并在更长的位置深度接近。这也允许更少的器械更换，从而减少了手术过程的时间。
第二实施方式的第二表现形式是封装刀且能够沿着纵向轴线移动的护套。
第二实施方式的第三表现形式是封装刀且能够相对于外壳旋转的护套。
超声外科器械的第三实施方式的第一表现形式是用于防止刀和/或护套沿着纵向轴线移动的锁定机构。
第三实施方式的第二表现形式是用于防止刀相对于外壳旋转的锁定机构。
附图说明
在后附的权利要求中具体地提出本发明的新颖特征。但是，通过参考结合附图的以下描述，可以最好地理解发明本身操作的模式和方法，其中：
图1A是示出了根据本发明的超声外科器械的一种实施方式的立体分解装配图；
图1B-C是图1A的装配好的器械的替代立体图；
图2A是本发明的一种实施方式的局部剖视立体图，其具有多个开关以支持刀的移动，且端部执行器处于最远位置；
图2B是本发明的一种实施方式的局部剖视立体图，其使用多个开关以支持刀移动，且端部执行器处于最近位置；
图2C是示出了利用定位部件的旋转机构的一种实施方式的分解剖视立体图；
图2D是具有多个开关的手动开关电路的一种替代实施方式的电路图；
图2E是移动机构的一种实施方式的剖视图，其利用了螺旋柔性电路，且端部执行器处于远侧位置；
图2F是移动机构的一种实施方式的剖视图，其利用了螺旋柔性电路，且端部执行器处于近侧位置；
图2G是具有螺旋柔性电路的电连接的一种实施方式的放大正视图；
图2H是本发明的一种实施方式的放大正视图，示出了利用定位部件的旋转机构的一种实施方式；
图2I是移动机构的一种实施方式的剖视立体图，其利用了电轨道连接器，且端部执行器处于近侧位置；
图2J是利用了电轨道的电连接的一种替代实施方式的放大图；
图2K是移动机构的一种实施方式的剖视立体图，其利用了电轨道连接器，且端部执行器处于远侧位置；
图2L是利用了圆形定位部件的旋转机构的一种实施方式的放大剖视立体图；
图2M是利用带套管的同心圆柱的电连接的一种实施方式的放大剖视立体图；
图2N是示出了带套管的同心圆柱的电连接的一种实施方式的分解装配图；
图3A是利用刀护套上的螺旋的移动和旋转机构的一种替代实施方式的分解立体图；
图3B是利用摩擦锁定的移动和旋转机构的一种实施方式的剖视立体图；
图3C-D分别是摩擦锁定旋钮的一种实施方式的正视图和侧视图；
图3D是摩擦锁定旋钮的一种实施方式的侧视图；
图3E是摩擦锁定旋钮的一种替代实施方式的侧视图和截面图；
图3F是利用摩擦锁定的移动和旋转机构的一种替代实施方式的分解图；
图4A是本发明的一种替代实施方式的正视图，示出了用于凝结的手指垫；
图4B是本发明的一种替代实施方式的侧视图，示出了用于凝结的手指垫；
图4C是本发明的一种替代实施方式的立体图，示出了棒上的用于凝结的手指垫；
图5A是刀和销组件的一种实施方式的剖视正视图；
图5B是刀和销组件的一种实施方式的分解装配图；
图6是本发明的利用了照明系统的一种替代实施方式的立体图；
图7A是本发明的包含了触摸环状致动组件的一种实施方式的立体图；
图7B是触摸环状致动组件的分解立体图；
图8A是平衡机构的一种实施方式的正视图；
图8B是平衡机构的一种实施方式的正视图；
图8C是具有可动配重的平衡机构的一种替代实施方式的正视图；
图8D是包含可动配重和齿轮系统的平衡机构的一种替代实施方式的正视图；
图9A是本发明的具有通过磁连接器连接的可滑动致动按钮的一种替代实施方式的立体图；
图9B是本发明的一种实施方式的剖视正视图，示出了磁轨道连接器；
图9C是通过磁连接器连接的致动按钮组件的一种实施方式的放大立体图；
图10是手动开关电路的电路图；
图11A是根据本发明的手动扳手的立体图；
图11B是图11A的手动扳手的正视图；
图11C是手动扳手的远端的截面端视图，其示出了悬臂和齿的几何结构；
图11D是适配器的截面图，示出了花键齿轮的几何结构。
具体实施方式
在详细解释本发明之前，应注意，本发明不将其应用或使用限制为在附图和说明书中描述的结构和零部件的布置的细节。本发明的示例性实施方式可在其它实施方式、变型和修改中执行或包含在其它实施方式、变型和修改中，并可以各种方式实践或实施。此外，除非另外指明，为方便读者，这里采用的术语和表述是为描述本发明的示例性实施方式的目的而选，而不是出于限制本发明的目的。
此外，应理解，下面描述的实施方式、实施方式的表现形式、实施例等的任何一个或多个可与下面描述的其它实施方式、实施方式的表现形式、实施例等的任何一个或多个组合。
本发明特别地涉及改进的超声外科器械，其被构造为在包括诸如整形外科手术等精细外科手术在内的外科手术过程中实现组织解剖、切割和/或凝结。本器械可以被构造为用在开放式外科手术中，但也可用在例如腹腔镜等其它类型的外科手术中。多样化的使用是通过选择性地使用超声能量来实现的。当器械的超声部件未受激励时，可以根据需要对组织进行操作，而不切割或损伤组织。当超声部件受到激励时，超声能量用于组织切割和凝结。
此外，本发明依照仅是刀的器械来公开。该特征不是用于限制，因为此处公开的实施方式可同等地应用于如美国专利No.5873873和6773444中示例性公开的夹钳凝结器械。
如从以下的描述中可清楚看到的，由于本发明的外科器械的简单结构，其被特别构造为一次性使用。同样，可以设想该器械与外科系统的超声发生器单元结合使用，由此，来自发生器单元的超声能量为本发明的外科器械提供所需的超声致动。应当理解，体现本发明原理的外科器械能够被构造为非一次性使用或者是多次使用的，并且与相关联的超声发生器单元不可拆卸地形成一体。然而，对于单个患者使用该器械来说，该外科器械与相关联的超声发生器单元的可拆卸连接在目前是优选的。
现在具体参照图1A-C，其示出了外科系统19的一种实施方式，该外科系统19包括根据本发明的超声外科器械100。外科系统19包括超声发生器300和超声外科器械100，超声发生器300经由线缆22连接到超声换能器50上。应当注意，在许多应用中，超声换能器50也被称作“手持组件”或者“手持件”，因为外科系统19的外科器械被构造为使得医生可在各种手术和操作过程中抓住并操作超声换能器50。合适的发生器是美国俄亥俄州辛辛那提的EthiconEndo-Surgery公司出售的GEN04(也称作Generator 300)。合适的换能器在2006年10月10日提交的序列号为No.11/545784的题为“MEDICAL ULTRASOUND SYSTEM AND HANDPIECE ANDMETHODS FOR MAKING AND TUNING”的共同未决美国专利申请中公开。
超声换能器50和超声波导管80一起提供了本外科系统19的声学组件，当声学组件由发生器300供能时，声学组件提供用于外科手术的超声能量。外科器械100的声学组件一般包括第一声学部分和第二声学部分。在本实施方式中，第一声学部分包括超声换能器50的超声驱动部分，第二声学部分包括传输组件71的超声驱动部分。此外，在本实施方式中，第一声学部分的远端例如通过螺纹连接可操作地连接到第二声学部分的近端。
超声外科器械100包括多件式手柄组件68，其适于使操作者与容纳在换能器50中的声学组件的振动隔开。手柄组件68的形状可以形成为能够由使用者以传统方式握持，但可以想到，该超声外科器械100主要以由器械的手柄组件提供的铅笔状设置被握持和操作，如下所述。尽管图示了多件式的手柄组件68，但该手柄组件68可以包括单个或一体的部件。通过将换能器插入到手柄组件68中，超声外科器械100的近端接收超声换能器50的远端并与该远端装配在一起。超声外科器械100可以作为一个单元从超声换能器50上拆装。超声外科器械100可以包括手柄组件68，该手柄组件68包括配合的外壳部分69、70和超声传输组件71。超声外科器械100的细长传输组件71从器械手柄组件68垂直地延伸。
手柄组件68可以由诸如聚碳酸酯或液晶聚合物等耐用塑料制成。还可以想到手柄组件68可以替代地由包括其它塑料、陶瓷或金属在内的多种材料制成。
传输组件71包括波导管80和刀79。应当注意，在一些应用中，传输组件有时被称作“刀组件”。适于将超声能量从换能器50传输至刀79的末端的波导管80可以是挠性的、半挠性的或刚性的。如本领域所公知的，波导管80还可以被构造为放大通过波导管80传输至刀79的机械振动。波导管80还可以进一步具有控制沿着波导管80的纵向振动的增益的部件和将波导管80调节到系统谐振频率的部件。具体来说，波导管80可以具有任何适当的横截面尺寸。例如，波导管80可以具有基本上均匀的横截面，或者波导管80可以在不同的部分逐渐变细或者可以沿着其整个长度变细。超声波导管80的长度例如可以基本上等于二分之一系统波长的整数倍(nλ/2)。优选地，超声波导管80和刀79可以由实心轴制造，该实心轴由诸如钛合金(即，Ti-6Al-4V)、铝合金、蓝宝石、不锈钢或任何其它声学相容材料等能够有效传播超声能的材料制成。
超声波导管80还可以包括至少一个径向孔或窗孔66，该径向孔或窗孔66基本上垂直于波导管80的纵向轴线延伸穿过波导管。可以定位在节点处的窗孔66被构造为接收连接器销27，如下所述，该连接器销27将波导管80连接至外部护套72。近侧的O形圈67a和远侧的O形圈67b在节点附近装配到传输组件71上。
刀79可以与波导管80形成为一体并形成为单个单元。在当前实施方式的替代表现形式中，刀79可以通过螺纹连接、焊接接头或其它连接机构来连接。刀79的远端或者刀末端79a设置为靠近腹点，以在没有用组织加载声学组件时将声学组件调节到优选的谐振频率fo。当超声换能器50被供给能量时，刀末端79a被构造为例如在55500Hz的预定振动频率fo下并且例如在大约10至500微米、优选在大约20至大约200微米的峰-峰范围内基本上沿纵向(沿x轴)运动。刀末端79a还优选沿y轴以沿x轴运动的大约1％至大约10％振动。
波导管80和刀79的一种实施方式是由美国俄亥俄州辛辛那提的Ethicon Endo-Surgery公司出售的编码为HF 105的产品，其在题为“ULTRASONIC SURGICAL BLADE WITH IMPROVED CUTTINGAND COAGULATION FEATURES”的美国专利No.6423082中进一步公开。也可以想到其它刀设计与本发明一起使用，包括EthiconEndo-Surgery公司销售的编码为DH105的产品，其在题为“ULTRASONIC SCALPEL BLADE AND METHODS OFAPPLICATION”的美国专利No.5324299中进一步公开。如本领域技术人员已知的，也可以使用其它超声刀设计。
波导管80设置在外部护套72内并借助销27保持就位。优选地，销27由诸如不锈钢或钛之类的任何相容性金属或者例如聚碳酸酯或液晶聚合物等耐用塑料制成。在一种实施方式的第一表现形式中，销27部分地涂覆有弹性材料，例如销27的延伸穿过波导管80的部分29涂覆有硅酮。硅酮使孔66的整个长度与振动刀隔离。从而能高效操作，几乎不会出现过热并且在用于切割和凝结的刀末端处得到最大超声输出功率。
外部护套72穿过释放按钮200的窗孔210。弹簧220设置在释放按钮下方并且在外壳部分69内，该弹簧220在释放按钮200上施加向上的力。该向上的力引起窗孔210向外部护套72稳固地施加压力并由此防止外部护套72和波导管80和刀79在手柄68内旋转或者相对于手柄68轴向移动。当使用者向释放按钮200上施加向下的力时，弹簧被压缩并不再在外部护套72上施加保持力。使用者然后可以使外部护套72和波导管80以及刀79相对于手柄68轴向移动和/或使外部护套72和波导管80以及刀79相对于手柄68旋转。
手柄68包括近端、远端和在其中纵向地延伸的腔59。腔59能够接收开关组件300和换能器组件50。在本实施方式的一种表现形式中，换能器50的远端螺纹连接到传输杆80的近端上。换能器50的远端也与开关组件300接合，以便向医生提供对外科器械19的手指致动控制。
换能器50包括第一传导环400和第二传导环410，它们如在序列号为No.11/545784的共同未决专利申请中描述的那样被稳固地设置在换能器主体50内。开关组件300包含按钮组件310、电路组件330、开关外壳350、第一销式导体360和第二销式导体370(见图10)。开关外壳350呈环形并通过开关外壳350和外壳部分69、70上的相应支撑安装座支撑在手柄组件68内。
还是参照图10，销360和370在一端分别经由导体337和335与薄膜开关332和334电连接，在第二端与换能器50的远端电连接。销360和370中的每个具有与换能器50接合的弹簧加载的末端。每个端部弹簧加载的末端的工作行程为0.050英寸，以允许与被装配的零件的叠加相关联的制造公差。
电路330经由换能器50在按钮321、322和发生器300之间提供了机电接合。电路330包括两个薄膜开关332和334，通过分别压下按钮321或322来机械地启动薄膜开关332和334。薄膜开关332和334是电接触开关，当被压下时，它们提供电信号至发生器300，如图10的电连接示意图所示。电路330还包含位于二极管封装336中的两个二极管以及本领域技术人员所公知的导体335和337，导体335和337分别连接到销360和370，销360和370又提供电接触至环导体400和410(未示出)，环导体400和410又连接至线缆22中的导体，线缆22连接至发生器300。
容易理解，通过压下按钮321和322，相应的接触表面压靠相应的薄膜开关332和334，以启动图10所示的电路。当医生压下按钮321时，发生器将以一定的能量水平(例如最大(“max”)功率设定)作为响应；当医生压下按钮322时，发生器将以一定的能量水平(例如最小(“min”)功率设定)作为响应，这符合用于按钮位置和相应功率设定的已经被接受的产业实践。
现在还参考图11A-D，图示了两件式转矩扳手450。转矩扳手包括手动扳手500和适配器550。在一种实施方式中，手动扳手500设有围绕手动扳手500的中心线以环形方式设置的悬臂501。悬臂501包括齿501a，齿501a在一种实施方式中以相对于悬臂501向内垂直的方式设置。在本发明的一种实施方式中，齿501a被设置成使得凸轮斜面501b相对于臂501和齿501a之间的直角成25°角。腔502在手动扳手500的整个长度上延伸，用于接收适配器550。
适配器550具有纵轴552，在纵轴552的远端设有悬臂翼片554。在轴552的近端是花键齿轮556，花键齿轮556沿着轴552的外圆周垂直地突出。花键齿轮556包括凸轮斜面556a，凸轮斜面556a被设置成相对于轴552的外圆周与花键齿轮556之间的直角成大约23°至大约28°的角。适配器还包括交接面560，交接面560与轴552刚性连接并且限定用于刚性接合外部护套72的远端的开口。
在装配中，转矩扳手开口502与轴552对准，并基本上沿着轴552的整个长度引导直到翼片554向内弯曲并且接合手动扳手500的远端处的肩形部505。凸轮斜面501b可滑动地接合保持器凸轮斜面556a。转矩扳手组件450可滑动地接合外部护套72的远端并且被刚性地保持在适当的位置。交接面560的平坦表面与位于外部护套72的远端处的平坦表面(未示出)配合。
顺时针方向环向运动或转矩通过叶片504施加至手动扳手500。转矩通过臂501和齿501a传递至齿轮556，齿轮556又将转矩分别经由绝缘销27、外部护套72传递至波导管80。当使用者施加5-12lbs的转矩时，斜面501b和556致使臂501运动或偏离扳手500的中心线，确保使用者不会将波导管80过度地拧紧在换能器50上。当经由叶片504向扳手500施加逆时针方向的转矩时，齿501a和556的垂直平面侧抵接，允许使用者向波导管80和换能器50之间的交接面提供与施加至叶片的力成比例的转矩，以辅助从换能器50上移去器械100。转矩扳手450可以由例如聚碳酸酯或液晶聚合物的耐用塑料制成。还可以想到，扳手450可以替代地由包括其它塑料、陶瓷或金属的多种材料制成。
在另一种实施方式(未示出)中，叶片和悬臂组件可以是单独的部件，它们可以通过诸如粘合或胶粘等机械或化学方法来连接。
优选地，在外科手术前对上述超声器械100进行如下处理。首先，获得新的或用过的超声器械100，如果有必要对该器械进行清洁。然后，可以对超声器械进行消毒。在一种消毒技术中，超声器械被放置在闭合且密封的容器中，例如塑料袋或高密度聚乙烯合成纸袋(TYVEK袋)。可选择地，超声器械能够与包括转矩扳手450的其它部件作为成套器具捆在容器内。容器、超声器械以及任何其它部件随后被放置在能够穿透容器的诸如伽玛辐射、x射线或高能电子的辐射场内。辐射线能杀死超声器械上和容器内的细菌。然后，经过消毒的超声器械能被存储在无菌容器内。密封容器保持超声器械无菌，直到它在医疗设备中打开。
按钮致动
图2A-B示出了致动按钮和手持件之间的电连接的一种替代表现形式。致动按钮422固定在外壳169a上。刀和护套组件400包含两个独立的薄膜开关位置，每个薄膜开关位置包含两个薄膜开关432a、432b和434a、434b。刀组件400移动以允许翘板式按钮422来致动通过近侧薄膜开关432或者远侧薄膜开关434的装置。当使用薄膜开关432时，端部执行器79b相对于外壳169a延伸。当使用薄膜开关434时，端部执行器79b相对于装置外壳169a缩回。图2D的电路图示出了并联电连接的两组开关。
参照图2E-G，图示了利用螺旋柔性电路640在手持件50和致动开关之间进行电连接的一种替代表现形式。螺旋柔性电路640承载了图2D的开关和手持件50之间的连接线。薄膜开关622通过螺旋柔性电路640连接到手持件连接器642上。螺旋柔性电路640允许护套180在薄膜开关和按钮622在外壳169b上保持固定时相对于外壳169b移动。薄膜开关622始终借助螺旋柔性电路640保持与换能器50连接。
电连接的另一种表现形式示出在图2I-K的轨道设计644中。电刷680用于通过电轨道644保持致动按钮625和手持件连接器646之间的电连接。轨道644在护套180在远侧位置650b和近侧位置650a之间移动时保持连接。
轴向移动
现在参照图2E-F，在护套180上具有用于移动的部件。定位部件650a和650b在刀护套180上间隔开并为端部执行器79b形成相对于外壳169b的两个位置。刀护套180还可以包含另外的定位部件，其可以为端部执行器79b形成另外的位置。定位夹635将轴180锁定到近侧定位位置650a或者远侧定位位置650b。使用者使定位夹635脱离接合并允许轴180从锁定位置650a移动到650b或者从650b移动到650a。这些定位部件用于使端部执行器79b相对于外壳169b移动。
旋转
参照图2C，为了允许端部执行器相对于外壳169a旋转，刀护套172包含与指状件610接合的均匀间隔开的4个定位部件630。指状件610运动进出定位部件630。这使端部执行器79b能够旋转并锁定在以90度间隔开的4个不同位置。图2H示出了旋转的一种替代表现形式。连接到护套180的销665能够在定位部件660a中旋转。定位部件660a包括在连接器655中均匀间隔开的5个部件。660a的任一侧上的槽660b和660c能够提供所需的定位转矩，以使端部执行器79b相对于外壳169b旋转。
如图2L所示，定位轮组件670用于使端部执行器79b能够进行360度旋转并利用了图2I-K的轨道部件。不可滑动的连接器672相对于轨道644可旋转地固定。翼片673间隔180度地设置在连接器672上并与设置在护套185上的定位轮676接触。定位齿678绕着定位轮676均匀间隔开。当端部执行器79b相对于外壳169c旋转时，翼片673运动进出齿678，从而将端部执行器79b锁定在合适的位置。这使得使用者能够改变使用的端部执行器相对于外壳169c的角度。两个电套管682a和682b设置在连接器672(未示出)的开口内，并且与静止的轨道644和同心的圆柱形组件690接触。圆柱形组件690包括护套185上的近侧圆柱形连接器691a。电圆柱形元件691b同心地配合在连接器691a周围，且圆柱形绝缘件691c同心地配合在电元件691b周围，电圆柱形元件691d配合在绝缘件691c周围。电套管682a和682b分别与位于一个连接点上的圆柱形元件691b和位于相对的连接点处的轨道644上的圆柱形元件691d接触。电套管682a和682b向手持件50提供电连接，因此在按钮625和手持件50之间提供持续的电连接。
现在参照图3A-F和图1，示出了用于使端部执行器79b伸缩和旋转的替代实施方式。刀护套772包含螺旋形式的槽702。槽702与端盖700以与螺母和螺栓相同的方式相互作用。护套772、槽702和端盖700都包含在外壳半部269a和269b内。随着护套772旋转，端部执行器79b将相对于外壳269前进和回缩。旋转和移动同步地发生且并不彼此独立。本实施方式的替代表现形式表现在护套775。护套775包含槽705，其节距分别在近端706a和远端706b附近发生改变。该节距的改变允许端部执行器79b相对于外壳269最大和最小延伸量得以进一步准确化。尽管旋转和移动仍然依靠彼此，但槽705为使用者给出了端部执行器79b相对于外壳269更多的位置。
现在参照图3B-F，其示出了摩擦锁定机构的另一种实施方式。旋钮720包含以180度均匀间隔开的齿705。旋钮720配合到外壳270的远端中。外壳270内的倾斜表面710用作斜面并在旋钮720旋转时与向内弯曲的齿705发生干涉。该干涉形成压缩力并使刀护套相对于外壳270锁定到合适位置。当干涉被释放时，刀护套利用前面讨论的任一种移动和旋转实施方式自由移动和旋转。旋钮720的一种替代表现形式是旋钮721。旋钮721包含齿706，齿706在旋钮721上切出并铰接在旋钮721上。当旋钮721在外壳270内旋转时，齿706向内弯曲并形成压缩力，从而将刀护套相对于护套270锁定。
摩擦锁定的一种替代表现形式是旋钮730。当旋钮730旋转时，其在外壳271a和271b之间形成干涉。该干涉引起旋钮730偏转，并向护套776施加压缩力和摩擦将其锁定在合适的位置。当旋钮730不形成干涉时，端部执行器79b能够相对于外壳271移动和旋转。
图7A和7B示出了致动按钮的一种替代实施方式。超声器械100b包含环状致动按钮组件810。环状致动按钮组件810包含8个部分810b。至少两个按钮部分810b必须接触以启动超声器械100b中的谐波能。超声器械100b能够适应不同的使用者握持。根据使用者拿持装置所用的手指数，器械100b能够在使用者与第二环部分810b接触时或者在使用者与第三环部分810b接触之后被致动。环形致动按钮组件810使超声器械100b能够容易地在医生手中旋转，同时向目标区域保持谐波能。
现在参照图9A-C，在一种替代实施方式中，可拆卸的致动按钮组件835沿着由超声外科器械100C承载的金属轨道842纵向移动。如本领域技术人员很清楚的，磁轨道电连接到手持件或者换能器50上。致动按钮组件835包含一个或者多个磁体840，以锚固到金属轨道842上并与金属轨道842形成电连接。磁体840覆盖在导电材料中并连接到薄膜开关838。薄膜开关例如通过翘板式按钮837致动；但是，本领域技术人员已知的任何类型的开关都是可用的。致动按钮组件835能够在超声外科器械100c上旋转以转换翘板式按钮837的最大和最小位置。致动按钮组件835还能够以滑动的方式运动到超声外科器械100c上的任何位置，磁体840在此处将组件835保持在金属轨道842上的合适位置。这使得端部执行器79c和致动组件835之间的距离可变。在该实施方式的一种表现形式中，端部执行器79c和轴180b相对于外壳68a固定，如图9A中所示；替代地，端部执行器79c和轴180b能够相对于外壳68a运动，如图9B中所示(端部执行器处于近侧位置)。
图5A和5B中示出了对准销27的一种替代表现形式。孔66b和后缓冲器62被再次定位在刀81b上的最小位移的位置。后缓冲器62利用例如硅酮的弹性材料包覆成型到刀81b上。通孔66的内壁也利用例如硅酮的弹性材料插入成型。对准销129不再包覆材料，并被压迫穿过刀护套73、后缓冲器62和刀81b。这个过程能够在对准销上节省成本，因为其涉及到消除了对准销的二次插入成型步骤。由于包覆成型的后缓冲器62和销129都可以放置在最小位移的位置处，因此也改进了声学并轻微减少了热量。
现在参照图8A-D，超声外科器械100的另一种实施方式是平衡部件820。在第一实施方式中，平衡部件820保持在外壳815内的固定位置，并且提供了器械100关于手持件50b相对于外壳815的多个位置的静态平衡。一种替代表现形式利用环形或者不对称形状形式的平衡件820b。
平衡系统的另一种表现形式是器械100关于手持件50b相对于外壳815的多个位置的动态平衡。平衡件820c通过带823和柱824在外壳815内滑动。带823连接到手持件50b。随着手持件50b向近侧缩回，通过手持件50b绕着柱824拉动带823，平衡件820c向远侧运动。一旦调节好，平衡件820c距离手持件50b更远地定位，以更好地平衡超声器械100c。随着手持件50b向远侧延伸，平衡件820c向近侧朝着系统的质量中心运动。
图8D的平衡件820d是可动平衡机构的一种替代表现形式。随着手持件50b向近侧和远侧收缩，平衡件820d借助小齿轮828和齿条829移动。小齿轮828连接到手持件50b。小齿轮828也可以连接到超声外科器械100c的其它部件上。平衡件820d的这种运动将平衡手持件50b的重量。该平衡系统将给出装置关于端部执行器相对于致动按钮的所有位置的最佳平衡。这在操作装置时给了使用者更好的精度。
现在参照图6和图1A，示出了包括LED环60的超声外科器械100a的一种替代实施方式。LED环60包括在外壳70的远端上均匀间隔开的一个或多个LED或者其它低能量光源。本领域的技术人员可以确定替代的光源或者结构来实现在谐波刀端部执行器79a的方向上指出光的目的。LED环60可以由外部电源或者电池组供能。LED环60可以利用也致动发生器300的按钮332和334启动。LED环60也可以持续地处于启动状态或者通过独立的开关启动。
与装置配套的套件的零件可以包括更好地凝结脉管的部件。现在参照图4A-C，本领域技术人员选择Teflon或者其它的相容材料构成手持的组织垫800来与谐波刀相互作用。垫800附着到指孔805并驻留在医生的非惯用手上。垫800用来向着闭合血管的刀端部执行器79a向血管施加压力。一种替代的表现形式包括棒807上的垫802。棒807由医生的非惯用手握持并用于向着闭合血管的刀端部执行器79a向血管施加压力。这能够改善止血和刀的多功能性。
虽然已通过多种实施方式的描述对本发明进行了说明，但本发明的申请人并不是想将后附的权利要求书的精神和范围限制得如此详细。许多改变、变化和替代可在不背离本发明的精神的前提下由本领域技术人员进行。此外，与本发明相关的每个元件的结构能够替代地描述为用于提供由该元件所执行功能的装置。由此，意图在于仅通过后附的权利要求书的精神和范围来限制本发明。

Claims (13)

1.一种超声外科器械，包括限定纵向轴线的外壳组件、从所述外壳组件向远侧延伸的外部护套、具有近端和远端并通过销连接到所述外部护套且设置于外部护套内的波导管、位于所述波导管远端的端部执行器、连接到所述波导管近端的换能器、与所述端部执行器以第一距离分开的能量致动元件、以及用于使所述端部执行器、所述波导管和所述外部护套沿着所述纵向轴线移动，从而使所述能量致动元件与所述端部执行器从以所述第一距离分开变为以可变第二距离分开的移动元件。
2.根据权利要求1所述的超声外科器械，其中，所述能量致动元件是固定的。
3.根据权利要求1所述的超声外科器械，其中，所述端部执行器是固定的。
4.根据权利要求1所述的超声外科器械，其中，所述端部执行器相对于所述纵向轴线移动。
5.根据权利要求1所述的超声外科器械，其中，所述端部执行器相对于所述能量致动元件旋转。
6.根据权利要求1所述的超声外科器械，其中：
所述外部护套由所述外壳组件可滑动地支撑并具有近端和远端。
7.根据权利要求6所述的超声外科器械，还包括由所述外壳组件支撑的锁定元件，该锁定元件提供防止所述外部护套相对于外壳组件移动的止动件。
8.根据权利要求7所述的超声外科器械，其中，所述锁定元件相对于外壳组件旋转。
9.根据权利要求7所述的超声外科器械，其中，所述锁定元件沿垂直于所述纵向轴线的方向运动。
10.根据权利要求6所述的超声外科器械，其中，所述外壳组件旋转地支撑所述外部护套。
11.根据权利要求10所述的超声外科器械，其中，所述外部护套包括槽。
12.根据权利要求6所述的超声外科器械，还包括照明组件。
13.根据权利要求6所述的超声外科器械，还包括平衡组件，该平衡组件提供抵消所述外部护套的运动的配重。
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JP5165696B2 (ja) 2013-03-21
WO2008089174A2 (en) 2008-07-24
CN101600393A (zh) 2009-12-09
EP2111166B1 (en) 2021-03-03
EP2111166A2 (en) 2009-10-28
WO2008089174A3 (en) 2008-10-02
US20080200940A1 (en) 2008-08-21
AU2008206385A1 (en) 2008-07-24
US20140222054A1 (en) 2014-08-07
BRPI0806674A2 (pt) 2014-05-13
JP2010515558A (ja) 2010-05-13
EP2111166A4 (en) 2012-12-19
US20160166275A1 (en) 2016-06-16
CA2675770A1 (en) 2008-07-24
CA2675770C (en) 2016-04-12

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