CN101522118A - 医疗器械 - Google Patents

医疗器械 Download PDF

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CN101522118A
CN101522118A CNA2007800366162A CN200780036616A CN101522118A CN 101522118 A CN101522118 A CN 101522118A CN A2007800366162 A CNA2007800366162 A CN A2007800366162A CN 200780036616 A CN200780036616 A CN 200780036616A CN 101522118 A CN101522118 A CN 101522118A
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blade
instruments
medical apparatus
nozzle component
clamping surface
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CN101522118B (zh
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弗朗茨·盖泽尔哈特
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Erbe Elecktromedizin GmbH
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Erbe Elecktromedizin GmbH
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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
    • A61B17/320016Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3201Scissors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1442Probes having pivoting end effectors, e.g. forceps
    • A61B18/1445Probes having pivoting end effectors, e.g. forceps at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
    • A61B18/1447Probes having pivoting end effectors, e.g. forceps at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod wherein sliding surfaces cause opening/closing of the end effectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1482Probes or electrodes therefor having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A61B2017/00473Distal part, e.g. tip or head
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/07285Stapler heads characterised by its cutter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B2017/320064Surgical cutting instruments with tissue or sample retaining means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1442Probes having pivoting end effectors, e.g. forceps
    • A61B2018/1452Probes having pivoting end effectors, e.g. forceps including means for cutting
    • A61B2018/1457Probes having pivoting end effectors, e.g. forceps including means for cutting having opposing blades cutting tissue grasped by the jaws, i.e. combined scissors and pliers

Abstract

在用于夹持和切割组织的医疗管轴器械中,安全的操作模式绝对必要。尤其重要的是始终向手术医师提供充足的信息从而使他能够判断是否已经成功地切断了待断开的组织。根据本发明,器械上设置有电极,因此能够以电学的方式判定刀片(51)与相关联的切割表面(12)之间的机械接触。

Description

医疗器械
技术领域
本发明涉及一种用于切割组织的医疗器械,具体为管轴器械。
背景技术
在现代医学中,通常力图使对完整组织的损伤保持到最小程度。因此,当情况允许时,微创手术常常是用来进行手术介入的优选方法。对组织的小切口和微创伤使得患者术后痛感低并使患者得以快速恢复和快速活动。这同样适用于在腹腔中实施复杂手术期间的腹腔镜手术。
这种手术以及这种手术所需要的器械给医疗器械制造商提出了特殊的挑战,因为大多数手术步骤是在非常有限的空间中进行的而且没有直接的视觉接触。因此所使用的医疗器械必须不仅能够在最小的空间中操作而且功能必需非常可靠使得无需视觉监控。这种器械优选构造成使得即使没有视觉接触实施手术的外科医生仍然一直获得使他能够对手术进展做出结论的反馈。
这尤其适用于所有适于分离组织的器械。由于具有敞开刀片的手术刀——如果有刀片的话——不适合用于微创手术,(参见DE 44 44 166A1),因此常常采用带有嘴部件的剪式或钳式器械,这些器械一方面在插入时遮盖刀片另一方面行使保持待切割的组织的功能。然后刀片在嘴部件内前后移位从而进行切割。
在钳式器械中,刀片或手术刀通常被相关联的嘴部件完全遮盖。因此,往往更难于对所夹持的组织是否已经通过一下或多下切割运动完全分离做出结论。然而,这一认知对于手术的有利进程而言至关重要。
另一方面,当组织已经分离时额外地使刀片运动会很快导致器械磨损。因此必需不断检查器械的切割能力并更换磨损的刀片。这种形式的维护不但昂贵而且耗费时间。通常不能更换器械的单个元件,这也是为什么更换整个器械的原因。
发明内容
从这样的现有技术出发,本发明的目的是提供一种医疗器械,该医疗器械确保可靠地分离组织并长久地保持功能。
该目的由根据本权利要求1所述的医疗器械来实现。
具体地,该目的由这样一种医疗器械来实现,该医疗器械具有:第一和第二嘴部件,其各自具有用于将组织固定和/或定位在固定平面中的至少一个夹紧表面;切割装置,其具有刀片,刀片与嘴部件中的一个相对地设置以便切割组织并能够在预定切割路径上基本平行于固定平面移位;第一电极和第二电极,其以能够通过连接至电极的处理单元来确定刀片与夹紧表面之间的机械接触的方式设置在切割装置和/或夹紧表面上。
因此本发明的基本理念是在用于分离组织的医疗器械中通过电极来确定刀片与相关联的夹紧表面之间的机械接触。能够以电学的方式或通过开关来确定这种机械接触。处理单元接收相应的信号并评估这些信号。
在优选实施方式中,刀片包括第一电极,夹紧表面包括第二电极,并且处理单元包括用于确定电极之间的电阻的装置。因此,第一电极由导电刀片或刀片的导电部分形成。第二电极为导电夹紧表面或夹紧表面的导电部分。处理单元测量第一电极与第二电极之间的电阻。优选地,当该阻抗低于预定的阈限时处理单元则判定紧位于刀片下面的组织被分离。这种情况是必然的,原因为待切割的组织具有一定的电导率因而当组织没有分离时第一电极与第二电极之间已然存在高电阻接触。通过指定阈值,能够区分经由待切割的组织形成的接触回路和两个电极之间的直接接触回路。该直接接触回路是刀片与夹紧表面之间进行机械接触的指示。
优选地,处理单元以能够确定切割路径上的阻抗曲线的方式设计。切割路径限定处理单元的观测间隔并且可以包括例如刀片在嘴部件的远端部分与近端部分之间的前后运动。
能够手动检测刀片的运动。因此在刀片在致动装置作用下的运动过程中机械限制止挡件能够提供关于行经的距离或行经的切割路径的信息。优选地,处理单元包括用于检测刀片平行于夹紧表面的位移的行程传感器和/或电开关。所述切割装置以其能够平行于夹紧表面沿医疗器械的纵轴线前后运动的方式设计。因此优选地,刀片应该不只是在一个位点处而是在沿纵向位移的整个切割区域上分离组织。为了有效地判断该区域中组织是否完全被分离,有利的是记录整个观测间隔或观测路径上刀片的运动并判断刀片与夹紧表面之间是否存在连续的机械接触。既可以直接地通过行程传感器来确定刀片的运动,也可以间接地通过位于切割范围的端部处的开关来判断刀片是否已经从第一开关移动到第二开关。在这里也是当刀片与夹紧表面之间在整个间隔期间或在整个切割路径范围内即刀片从第一开关运动到第二开关期间都存在机械接触或电接触尤其是低电阻接触时才能认定组织已经完全分离。
优选地,两个嘴部件各自包括用于使所固定的组织凝结的凝结电极。因此,能够在通过刀片进行机械分离之前利用高频电流使组织凝结。确保了机械分离之前的血管的安全封闭。此外,可以将两个凝结电极中的一个连接至处理单元从而用于判定所述机械接触。为了形成凝结电极,嘴部件至少局部导电或者在面向组织的一侧具有导电涂层。
优选地,至少一个嘴部件包括刀片引导装置。刀片引导装置用于在切割运动期间稳定刀片。此外,刀片引导装置可具有所述开关或行程传感器以便确定刀片的运动。
优选地,医疗器械具有用于发射信号的装置,当整个切割路径上的阻抗都下降到低于预定的最小值时就发射信号。因此,这种显示形式不仅能够用于判断阻抗进而判断进行组织分离时的刀片在某一点或某一位置处的进展,而且能够用于判断在整个切割路径上组织的完全分离。
根据其它从属权利要求形成其它有利的实施方式。
附图说明
下面将基于将通过附图更加详细地说明的实施方式来描述本发明。
附图中:
图1示出用于分离组织的管轴器械;
图2示出图1的管轴器械的工具头,其中工具头包括第一嘴部件和第二嘴部件;
图3示出第二嘴部件的立体侧视图;
图4示出第二嘴部件的俯视图;
图5示出第二嘴部件的侧视图;
图6示出第一嘴部件的立体侧视图;
图7示出第一嘴部件的俯视图;
图8示出第一嘴部件的侧视图;
图9示出两种不同铰接装置的示意图;
图10示出具有切割装置的图2的工具头的剖视图;
图11示出切割装置的示意图;
图12示出位于管轴器械的管轴中的切割装置的示意图;
图13至图15示出切割刀片的三种实施方式;
图16示出切口监控装置的框图;
图17示出处于张开位置的工具头的立体图;
图18示出处于闭合位置的图17的工具头;
图19示出具有张力带的第二嘴部件;以及
图20示出管轴器械的示意性侧视图。
具体实施方式
在以下描述中相同的附图标记用于同样的部件和以同种方式发生效用的部件。
图1提供了根据本发明的管轴器械的实施方式的大致概观。其示出了管轴器械的三个功能性部件:手柄110、稍长的管轴24以及设置在管轴24的远端上的工具头30。工具头30提供管轴器械的实际功能。工具头用于切割和/或凝结组织。手柄110控制工具头30的运动。具体地,可以通过手柄110使嘴部件10、10’(参见图2)闭合和张开以便固定、凝结以及切割组织。
图2示出了根据本发明的工具头30的实施方式,工具头30包括第一嘴部件10和第二嘴部件10’。第一嘴部件10是椭圆体,在其面向管轴24的侧部上具有刚性接合到所述管轴24的适配器25。第二嘴部件10’通过铰接装置40附连到第一嘴部件10并且能够从用于抓持组织的张开位置进入用于固定组织的闭合位置。铰接装置40设计成使得虚拟支轴1或枢轴位于第一嘴部件10和第二嘴部件10’外部。因此,与用于这种器械的常规铰接装置40不同,支轴1不是在管轴24中或嘴部件10、10’相接合的区域中定位地靠近管轴24的纵轴线。示出的铰接装置40的机构表现为使得虚拟支轴1形成在管轴器械的面向第二嘴部件10’的一侧上方。
在图9的示意图的基础上示出了这种重新定位的支轴1的具体优点。左上角中示出的是常规铰接装置,其支轴1大体定位在嘴部件10和10’的纵轴线上。在张开位置,第二嘴部件10’的末端16’相对于第一嘴部件10的末端16朝后偏。然而,图9的另外两幅图中示意性地示出的根据本发明的铰接装置40却不是这种情况。其中支轴1明显位于两个椭圆形嘴部件10、10’的纵轴线上方。即使在张开状态下,在由第一嘴部件10相对于第二嘴部件10’所形成的角度开度相同的情况下,第二嘴部件10’的末端16’仍然基本定位在经过第一嘴部件10的末端16的垂直直线上或前方。因此如果第二嘴部件10’相对于第一嘴部件10张开,那么第二嘴部件10’不仅具有其间第二嘴部件10’相对于第一嘴部件10的相对布置发生改变的旋转位移而且具有向远侧定向的纵向位移,即,沿第一嘴部件10的末端16的方向平行于第一嘴部件10的纵轴线的位移。反之,在嘴部件10、10’的闭合运动过程中,第二嘴部件10’具有沿近侧方向的纵向位移。因此,最终将位于两个嘴部件10、10’之间的组织拽入工具头30中。此外,在张开角度相同的情况下,根据本发明,第二末端16’的升距——即第一末端16与第二末端16’之间的距离——明显较大(参见图9,右侧)。在一种实施方式中,嘴部件10、10’的长度相对于第一嘴部件10的纵轴线到支轴的距离之比约为10:1。
虽然在图9中为清晰起见而通过竖直地附连在嘴部件10、10’的近端上的延伸部来实现支轴1的重新定位,但是在优选实施方式中支轴1的形成完全是虚拟的。这种虚拟设计由以下基于图3至图8进行说明的槽孔式引导系统来实现。因此,如图3所示,第二嘴部件10’在其与末端16’相反的近端上具有两个弯曲的铰接导轨41、41’。从上面看(参见图4),这些铰接导轨41、41’基本平行地沿第二嘴部件10’的纵轴线延伸,并且间隔开以形成通道。
从侧面看(参见图5),第二嘴部件10’具有勺状轮廓。因而,第二嘴部件10’——具体为铰接导轨41、41’——的近端各自在它们的上侧具有与第一嘴部件10接合的凹部43、43’。如图6所示,为此该嘴部件10具有两个铰接导销42、42’,每个铰接导销具有凸起结构部。在嘴部件10、10’张开和闭合运动的过程中,第一铰接导轨41的凹部43在相邻的、第一铰接导销42的凸部上面滑动,而第二铰接导轨41’的凹部43’在相邻的、第二铰接导销42’的凸部上面滑动。两个铰接导轨41、41’的凹部43、43’和铰接导销42、42’的对应部分的曲率决定了虚拟支轴1的位置。与弯曲较不明显的情况相比,在弯曲较明显的情况下支轴1更靠近工具头30。对应于较明显或较不明显的情况产生根据图9所描述的效果。
与仅具有单点连接的铰接装置相比,引导机构或铰接装置40还具有高稳定性的优点。由于凸部和凹部彼此接合,因而形成大面积的接触区域并且与具有单点连接的铰接装置相比铰接装置40能够吸收明显更多的力。为了进一步稳定铰接装置40,第一嘴部件10包括第一铰接导向轴承46和第二铰接导向轴承46’。和铰接导销42、42’相同,铰接轴承46、46’交替地附连在第一嘴部件10的侧壁的内侧。
第一铰接导向轴承46和第一导销42间隔开,使得它们在它们之间的空间中容置第一铰接导轨41。第一铰接导向轴承46具有与第一铰接导轨41的凸部44接合的凹入截面。当张开和闭合工具头30时,第一铰接导轨41由第一导销42和第一铰接导向轴承46引导着绕支轴1旋转。
同样,第二铰接导轨41’由第二导销42’和第二铰接导向轴承46’引导着绕支轴1旋转。为此,第二铰接导轨41’、第二铰接导销42’、第二铰接导向轴承46’以及第二铰接导轨41’的凸部44’与第一铰接导轨41、第一铰接导销42、第一铰接导向轴承46以及第一铰接导轨41的凸部44设计并设置成对称的。
如图10所示,在第二嘴部件10’的近端上附连有张力带27。更准确地,张力带大约附连在铰接导轨41、41’的凸部44、44’的中间。为此,铰接导轨41、41’具有用于形成对接边缘2(图5)的轮廓。优选地,该对接边缘2不是沿平行于支轴1的直线延伸而是设计成半圆形的(参见图19)。由于沿该长形的对接边缘2焊接第二嘴部件10’和张力带27,因此使力均匀地传递到张力带17中并且显著地提高了焊缝的拉伸及弯曲承载能力。在替代实施方式中,能够想到提供可比拟结果的锐角焊缝或具有多个细齿的焊缝。张力带27的平行于支轴1的宽度实质大于其厚度。这确保张力带27在第二嘴部件10’旋转时的弹性和可弯曲性。然而,张力带27在管轴器械的纵向上是相对刚性的,使得还能够产生剪切力。
通过将张力带27的第一端部附连到铰接导轨41、41’的凸部44、44’,确保了通过张力带27施加的张力总是与弯曲的铰接导轨41、41’绕支轴1的圆周运动大体相切地作用。因而确保了力不依赖于张开角度而均匀传递。张力带27的第二端部可操作地连接至手柄110,并且能够通过设置在手柄110上的控制装置移位。如已说明的,由于虚拟支轴1位于嘴部件10、10’的外部和上方,因此支轴1与张力带27的第一端部之间的距离显著大于通过普通铰接装置所得到的距离。因此所述管轴器械的实施方式具有明显较大的杠杆作用,能够借杠杆作用通过张力带27使第二嘴部件10’运动。
两个嘴部件10、10’均具有用于固定组织的夹紧表面12、12’。因而第一嘴部件10在远端部分上具有面朝上的第一夹紧表面12。第一夹紧表面12大体形成为横穿第一嘴部件10的纵轴线的凹面。当工具头30处于闭合状态时,第二嘴部件10’的凸出的第二夹紧表面12’基本平行于该第一夹紧表面12放置。
在所述实施方式中,这些夹紧表面12、12’不仅适于牢靠地固定以后待进行切割的组织,而且还形成用于凝结处理的电极。为此,夹紧表面12、12’的部分是导电的并经由印刷导体连接至同样能够通过手柄110控制的高频电源。因此,可以在切割程序之前将所夹持的组织烧灼至能够在不流血的情况下实现分离的程度。优选地,至少嘴部件10、10’的部分由陶瓷材料通过注塑模制方法制成。因此易于形成铰接装置40的引导元件,具体为铰接导轨41、41’和铰接导销42、42’。陶瓷材料的铰接装置40形成嘴部件10、10’之间——具体是它们的用于进行凝结的电极之间——的电绝缘。
在本实施方式中,实际的机械切割过程发生在凝结之后。为此,切割装置50平行于由夹紧表面12、12’所限定的固定平面x-y(参考图11)运动。除引线52之外,该切割装置50还包括用于分离组织的刀片51,刀片51能够通过引线52沿管轴器械的纵向(x轴)移位。
在切割过程之前,将刀片51朝管轴24向回拉足够远使得不会过早伤到组织。优选地,第一嘴部件10中的刀片处于铰接导销42、42’的层面上。以此为起点,刀片51经由一体结合在第二嘴部件10’中的坡道55(为此参见图4)进到固定平面x-y上。该坡道55位于两个铰接导轨41、41’之间。第二嘴部件10’提供了用于刀片51或刀具进行移位的刀片引导装置53。该刀片引导装置53是沿第二嘴部件10’的纵轴线延伸的椭圆开口。为了将刀片51保持成垂直于固定平面x—y,第二嘴部件10’在其中间区域中具有侧部件60、60’,侧部件以它们形成纵向延伸的通道的方式彼此平行地设置。在该通道中引导刀片51或刀具。
因此,在嘴部件10、10’闭合之后,刀片51从坡道55上面滑出其起始位置并滑入所述通道中,并且可以在所述通道中拉着远离或推着接近组织。相对于固定平面x-y对刀片51进行预加载,从而确保这种移位逐步地将组织分离。预加载装置施加垂直于固定平面x-y的力,从而挤压刀片51抵靠所述平面。该力通过引线52的弹力及其弯曲形成。如图12所示,引线52在由刀片51预加载的平面中垂直于固定平面x-y弯曲。在引线52的前部设置有弯折部56。弯折部56以这种方式一体结合在引线52中,即,使切割装置50处于完全伸出的状态即当刀片52位于嘴部件10、10’的远端时,管轴24中的弯折部同样位于所述轴的远端。弯折部56用于将由于引线52垂直于固定平面x-y弯曲而施加的力的至少一部分传递至管轴24,并且弯折部56具有相应的接触点。引线52的弯曲设置成使得如果引线的近端平行于管轴24延伸,那么未进行附连的引线52的远端向下弯曲并使刀片51至少部分地位于固定平面x-y下方。引线52以使刀片51能够通过手柄110在工具头30中来回运动的方式可操作地连接至手柄110。
就刀片51的设计而言能够想到多种变化的实施方式。以下将基于图13、图14以及图15描述这些实施方式。本发明的一种构思是刀片51具有基本平行于固定平面x-y进而平行于被固定的组织延伸的至少一部分。因此,在切割过程中,刀片51滑动穿过组织直至组织完全分离。因此与常规切割过程中不同,这样能够确保即使当刀片51变钝时组织仍将能够得以分离且不会因机械压力而压伤。切割刀片的平行于固定平面x-y形成的该部分还具有使刀片51并非仅在一点处而是通常在较长的区域范围上置于组织上的优点。因此防止刀片51在某一点处破损。
图13示出了具有凸形弯曲部的半圆形刀片51。刀片51设置在引线52的下侧。刀片51并且具有远离和靠近管轴器械的刀片弯曲部54。
图14示出了包括彼此前后设置的两个半圆部的刀片51。
图15示出了具有远端刀片弯曲部54和垂直于引线52的近端部分的刀片51。
优选地,刀片51是整体带有细齿的。
在替代性实施方式中(例如参见图10),引线52是轨道。轨道可以以其具有与引线52相同的功能的方式设计。能够通过轨道内在的弹性或通过独立装置(例如,弹簧)实现相对于固定平面x-y的预加载。
尽管到目前为止已经结合有利的铰接形状描述了本发明的有利的切割装置50。然而,还可以将两项发明彼此分开来实施。
因此,例如图17和图18示出了位于工具头30中的切割装置50,由此第二嘴部件10’不是通过槽孔式引导系统与第一嘴部件10操作性地连接。在此支轴1基本位于嘴部件10、10’的纵轴线上。
在根据本发明的一种实施方式中,管轴器械还包括切割监控装置。该切割监控装置判断两个夹紧表面12、12’之间的组织何时完全被分离。在该实施方式中,当组织彻底分离时刀片51搁置在第一夹紧表面12上。由于夹紧表面12包括用于凝结的电极,因此至少其局部是导电的。根据本发明,刀片51的在组织分离时机械接触分离表面12的至少一部分同样由导电材料形成。刀片51与夹紧表面12之间的电接触通过切割监控装置来判断。在经由第二嘴部件10’的末端16’直至坡道55的完整的切割远动的过程中当刀片51与夹紧表面12之间存在连续的电接触时则视为所夹持的组织完全被分离。如图16所示,切割监控装置包括处理单元100、显示装置101、开关103以及用于确定和显示切割过程的进展的行程传感器102。行程传感器102确定刀片51的位置或位移从而有助于限定出优选覆盖完整的刀片运动的观测期。在最简单的情形中,开关103通过导电的刀片51和第一夹紧表面12形成。由于待切割的组织具有一定的导电性,因此只有当夹紧表面12与刀片51之间存在低电阻连接时才认为电开关103是闭合的。在处理单元100的上游连接有相应装置。如果处理单元100确定在整个观测期期间刀片51和夹紧表面12之间存在连续的低电阻接触,那么它通过显示装置101向使用者指示所夹持的组织已经彻底分离。由于刀片51在其与夹紧表面12之间没有组织被夹入的情况下在夹紧表面12上移位会损坏切割装置,因此小心地对待切割装置50。
可替代地,还可以不断地向使用者指示刀片51与夹紧表面12之间是否存在直接的机械接触。由于使用者手动操作刀片51的运动,因此他能够独立地得出组织是否充分分离的结论。
在另一种实施方式中,行程传感器102包括在刀片引导装置53的远端和近端上的两个电接触区域,并且所述两个电接触区域以能够判断刀片51与远接触区域以及刀片51与近接触区域之间的接触的方式设计。于是处理单元100能够确定观测间隔的起点与终点。
图20示出了图1的手柄110的示意性详细视图。手柄110包括手柄体117,在手柄体117下面一体形成有第一手柄杆122。该手柄杆122具有用于容置多个手指——优选为中指、无名指以及小指——的开口。第二手柄杆122’以可旋转的方式靠近第一手柄杆122接合到手柄体117。可以通过使第二手柄杆122’相对于第一手柄杆122靠近和远离的移位来张开和闭合工具头30的嘴部件10、10’。手柄杆122、122’形成手触发器120因而能够抓握在使用者的手中使得能够凭借一只手来操纵整个管轴器械。为此,手环绕手柄杆122、122’的部分。接合在齿条124中的延伸部位于第二手柄杆122’的背对手柄体117的端部上。该齿条124在第一手柄杆122的背对手柄体117的端部上以直角附连到第一手柄杆122的纵轴。齿条24的齿型以这样的方式设计:即,使第二手柄杆122’能够逐步地朝手柄杆122运动并且在不持续施力的情况下相应设定的位置保持不变。为了松开手柄杆122、122’彼此之间的这种紧固,以使齿条124和延伸部125不再啮合的方式按压齿条124远离延伸部125。
另外,手柄110具有同样以可旋转的方式附连到手柄体117的指触发器130。可以通过操作指触发器130使具体为刀片51的切割装置50朝远处移位。手柄体117内部的弹性元件(未示出)使指触发器130在操作后回复至其起始位置,因此使切割装置朝近处移位。以能够在抓握手柄杆122、122’的同时由第一指来操作指触发器130的方式来将指触发器130在远侧处设置在第一手柄杆122前面。
手柄110在手柄体117的近侧具有控制凝结电流的瞬时接触开关116。在替代性实施方式中,能够将瞬时接触开关116替换成提供具有多个致动元件的控制装置,可以通过该控制装置对多种凝结模式进行选择和操作。还能够想到在手柄体117上设置显示装置101。
在根据本发明的一种实施方式中,管轴24和手柄110以管轴24能够以可拆卸的方式插入手柄110中的方式设计。为此,在手柄110的侧部上设置有能够通过罩盖封闭的接收口112。
因此,在操作之前,将具有合适的工具头30和切割装置50的一次性消毒管轴24插入并锁定在可重复使用的手柄110中。不想重复使用管轴24以及相关联装置。手柄体117具有用于机械地连接工具头30、切割装置51以及管轴24的第一耦联元件或耦联元件114、第二耦联元件或耦联元件114’以及第三耦联元件114”或耦联元件。设置在管轴24的近端上的环以使管轴刚性连接至手柄体117的方式与第三耦联元件114’接合。第一内管适配器22通过同样设置在近端上的环与第一耦联元件114接合,第一耦联元件114与第二手柄杆122’操作性地连接。第二手柄杆122’的位移通过设置在手柄体117内部的机构传递至第一耦联元件114进而将该位移传递至第一内管适配器22。该第一内管适配器通过张力带27直接或间接地机械结合到第二嘴部件10’。因此第一内管适配器22相对于管轴24的纵向移位使嘴部件10、10’张开和闭合。
第二内管适配器22’以能够相对于第一内管适配器22的运动的方式设置在所述第一内管适配器22内。该内管适配器22’操作性地连接至引线52并使刀片51移动。管轴24插入手柄体117中使位于第二内管适配器22’的近端上的环与第二耦联元件114’接合,并且将通过指触发器130施加的力或位移传递至切割装置50。
为了使得更容易插入一次性管轴24,在管轴24上设置有可拆除的紧固装置,该紧固装置将内管适配器22、22’相对于管轴保持在预定位置,并且以使环容易插入耦联元件114、114’、114”中的方式设计。
耦联元件114、114’、114”以使管轴24能够相对于手柄110旋转的方式设计。因此能够自由调节工具头30相对于手柄110的对齐。在旋转过程中,内管适配器22、22’和管轴24的环在耦联元件114、114’、114”中旋转从而形成铰接。
附图标记列表
1         支轴
2         对接边缘
10、10’  嘴部件
12、12’  夹紧表面
16、16’  末端
22、22’  内管适配器
24        管轴
25        适配器
27        张力带
30        工具头
40        铰接装置
41、41’          铰接导轨
42、42’          铰接导销
43、43’          铰接导轨的凹部
44、44’          铰接导轨的凸部
46、46’          铰接导向轴承
50                切割装置
51                刀片
52                引线
53                刀片引导装置
54                刀片弯曲部
55                坡道
56                弯折部
60、60’          侧部件
100               处理单元
101               显示装置
102               行程传感器
103               开关
110               手柄
112               接收口
114、114’、114” 耦联元件
116               瞬时接触开关
117               手柄体
120           手触发器
122、122’    手柄杆
124           齿条
125           延伸部
130           指触发器
x             x轴
y             y轴
z             z轴

Claims (17)

1.医疗器械,具体为管轴器械,所述医疗器械包括:
-第一和第二嘴部件(10、10’),所述第一和第二嘴部件(10、10’)各自具有用于将组织固定和/或定位在固定平面(x-y)中的至少一个夹紧表面(12、12’);
-切割装置(50),所述切割装置(50)具有刀片(51),所述刀片与所述嘴部件(10、10’)中的一个相对地设置以便切割组织,并且所述刀片能够经由可预先确定的切割路径基本平行于所述固定平面(x-y)移位;
第一电极和第二电极,所述第一和第二电极以以下方式设置在所述切割装置(50)和/或所述夹紧表面(12)上:所述刀片(51)与所述夹紧表面(12)之间的机械接触能够通过连接至所述电极的处理单元(100)来确定。
2.如权利要求1所述的医疗器械,其特征在于,
所述刀片(51)包括所述第一电极,所述夹紧表面(12)包括所述第二电极,并且所述处理单元(100)包括用于确定所述电极之间的电阻的装置。
3.如前述权利要求中任一项所述的、特别是如权利要求2所述的医疗器械,其特征在于,
所述处理单元(100)以能够确定所述切割路径上的阻抗曲线的方式设计。
4.如前述权利要求中任一项所述的医疗器械,其特征在于,
所述处理单元(100)包括用于检测所述刀片(51)平行于所述夹紧表面(12)的位移的行程传感器(102)和/或电开关。
5.如前述权利要求中任一项所述的医疗器械,其特征在于,
两个嘴部件(10、10’)各自包括用于使所固定的组织凝结的凝结电极。
6.如前述权利要求中任一项所述的医疗器械,其特征在于,
至少一个嘴部件(10’)包括刀片引导装置(53)。
7.如前述权利要求中任一项所述的医疗器械,其特征在于,
所述医疗器械具有用于发射信号的装置,当整个所述切割路径上的阻抗下降到低于预定的最小值时则发射所述信号。
8.用于分离组织的医疗器械,具体为电手术管轴器械,其特征在于,所述医疗器械包括:
结合到所述嘴部件(10、10’)的管轴(24),
由此,所述刀片(51)能够通过致动装置以基本平行于所述固定平面(x-y)移位的方式被引导,并且由预加载装置(56)预加载成在切割过程中抵靠所述固定平面(x-y)
9.如前述权利要求中任一项所述的、特别是如权利要求8所述的医疗器械,其特征在于,
所述预加载装置(56)包括具有弯度的弹性引线(52),由此,所述引线(52)基本刚性地结合到所述刀片(51),并且以沿所述固定平面(x-y)的方向使所述刀片(51)相对于所述管轴进行预加载的方式在所述管轴(24)中被引导。
10.如前述权利要求中任一项所述的、特别是如权利要求8或9所述的医疗器械,其特征在于,
所述预加载装置(56)包括弯折部,所述弯折部设置在所述引线(52)中使得在所述刀片(51)被朝前推动时所述弯折部向所述管轴(24)的远端靠近。
11.如前述权利要求中任一项所述的、特别是权利要求8至10中任一项所述的医疗器械,其特征在于,包括:
特别是坡道形状的刀片引导装置(53),所述刀片引导装置(53)设计并设置成其使得所述刀片(51)通过沿所述切割方向(x)运动而从离开所述固定平面(x-y)一定距离的起始位置到所述固定平面(x-y)上。
12.如前述权利要求中任一项所述的、特别是权利要求8至11中任一项所述医疗器械,其特征在于,
所述嘴部件(10、10’)设置成能够相对于彼此旋转,并且所述刀片引导装置(53)设计成使得所述刀片(51)能够进入靠近所述嘴部件(10、10’)的支轴的起始位置。
13.如前述权利要求中任一项所述的医疗器械,具体为用于夹持和/或凝结和/或分离组织的管轴器械,其特征在于,包括:
管轴(24),所述管轴(24)用于容置所述嘴部件(10、10’);以及
至少一个铰接装置(40),所述铰接装置(40)用于以使所述嘴部件(10、10’)能够从张开位置进入闭合位置从而利用所述夹紧表面(12、12’)固定所述组织的方式可旋转地支撑所述嘴部件(10、10’),由此,所述铰接装置(40)以所述铰接装置(40)的支轴(1)位于所述嘴部件(10、10’)外部并且至少一个嘴部件(10、10’)的远端能够在张开时远离所述管轴(24)的远端进行移位的方式设计。
14.如前述权利要求中任一项所述的、特别是如权利要求13所述的医疗器械,其特征在于,
所述铰接装置(40)包括槽孔式引导系统。
15.如前述权利要求中任一项所述的、特别是如权利要求13或14所述的医疗器械,其特征在于,
所述铰接装置(40)包括位于两个嘴部件(10、10’)中的一个上的铰接引导装置和位于所述两个嘴部件(10、10’)中的另一个上的至少一个轨道或槽。
16.如前述权利要求中任一项所述的、特别是权利要求14至16中任一项所述的医疗器械,其特征在于,
设置有至少两个部分铰接装置(40、40’),所述部分铰接装置(40、40’)彼此间隔开以形成优选设置于所述部分铰接装置(40、40’)中间的通道。
17.如前述权利要求中任一项所述的医疗器械,其特征在于,
为了打开和闭合待移位的嘴部件(10’),设置有能够大体沿直线移位的带,所述带通过弹性的端部附连在待移位的所述嘴部件(10’)上。
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