CN102143715A - 超声外科刀片 - Google Patents
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Abstract
本发明公开了一种超声外科刀片,其包括具有外表面、至少一个刀刃和远端的主体。在至少一个实施例中,所述刀刃可由第一和第二表面限定,在所述第一和第二表面之间限定了角度。在各实施例中,所述刀刃的至少一部分包括锋利点。在其它实施例中,所述刀刃和表面的至少一部分包括锋利点和/或斜表面。
Description
相关专利申请的交叉引用
本申请要求于2008年9月3日提交的美国临时申请No.61/093,836的优先权,该申请的内容以引用方式并入本文。关于联邦资助研发项目的声明
不适用。
技术领域
各实施例总体上涉及用于外科器械中的超声外科刀片,更具体地讲,涉及具有改进的切割和凝结特征的超声外科刀片。
背景技术
包括空芯器械和实芯器械在内的超声器械用于安全有效地治疗许多病症。超声器械,尤其是实芯超声器械是有利的,因为它们可以向外科端部执行器传输超声频率的机械振动,以这种形式的能量切割和/或凝结有机组织。当以合适的能量级传输至有机组织并且使用合适的端部执行器时,超声振动可用于切除、解剖、拉升或烧灼组织或用于使肌肉组织与骨骼分离。由于可以通过波导管从超声换能器传输至外科端部执行器的超声能量的量,使用实芯技术的超声器械尤其有利。此类器械可以用于开放式手术或微创手术,例如内窥镜手术或腹腔镜手术,其中端部执行器穿过套管针到达外科部位。
以超声频率激活或激励此类器械的端部执行器(例如,切割超声刀)可以引发纵向振动,该纵向振动在相邻组织内产生局部热量,从而有助于切割和凝结。由于超声器械的该特性,因此特定的超声致动的端部执行器设计可用于执行许多功能,包括(例如)切割和凝结。
例如,通过电激励换能器在外科端部执行器中引发超声振动。换能器可由器械手柄中的一个或多个压电元件或磁致伸缩元件构成。由换能器部分产生的振动通过超声波导管传输至外科端部执行器,该超声波导管从换能器部分延伸至外科端部执行器。将波导管和端部执行器设计成以与换能器相同的频率共振。因此,当端部执行器连接到换能器时,整个***的频率与换能器自身的频率相同。
用于超声外科器械中的超声外科刀片或端部执行器的形状可限定该器械的至少四个重要方面。它们是:(1)端部执行器的可见性及其在手术野中的相对位置;(2)端部执行器进入或接近目标组织的能力;(3)超声能量耦合到组织以进行切割和凝结的方式;和(4)用超声未激活的端部执行器操纵组织的方式。提供一种在器械的至少这四个方面优化的改进的外科器械超声刀或端部执行器将是有利的。
实芯超声外科器械可以分为两种类型,即具有单元件端部执行器的器械和具有多元件端部执行器的器械。具有单元件端部执行器的器械包括诸如解剖刀和球形凝结器的器械。当组织柔软并且被松散地支承时,单元件端部执行器器械使超声刀向组织施加压力的能力是有限的。要有效地将超声能量作用到组织上,必须提供较大压力。这样无法夹住组织的结果会进一步导致在施加超声能量时不能够完全接合组织表面,从而导致无法完成预期的止血和组织接合。多元件端部执行器(例如夹紧凝固器)的使用包括将组织压在超声刀上的机构,可以克服这些缺点。
超声夹紧凝结器提供用于切割/凝结组织,尤其是松散无支撑组织的改进超声外科器械,其中超声刀与对组织施加压缩力或偏置力的夹具一起使用,使得组织的凝结和切割更快并且超声刀运动的衰减较少。
目前的超声刀设计是针对软组织优化的。在存在软组织(例如内脏)至硬组织(例如软骨)的连续组织的情况下,目前的超声刀设计优先切割软组织。当超声刀碰到更坚固或更硬的组织时,超声刀趋于从这些组织偏离并沿着阻力最小的路径继续前进。这种性能对于在组织平面之间进行解剖来说是优选的,但是难以切割硬组织,例如软骨。
因此,对于能够切割不同的组织类型的超声刀存在显著需求。本发明提供这种超声装置。
附图说明
本发明的新颖特征在所附权利要求书中特别地加以阐明。然而,引用以下描述并结合附图可以最好地理解本发明本身的构造和操作方法,在这些附图中:
图1示出了超声外科***的一个实施例;
图2是现有技术的超声刀的透视图;
图3是本发明的一个实施例的透视图;
图4是本发明的一个实施例的替代表现形式的透视图;
图5是本发明实施例的一个表现形式的正视局部剖面图;
图6是本发明实施例的替代表现形式的正视局部剖面图;
图7是本发明实施例的替代表现形式的正视局部剖面图;
图8是本发明实施例的替代表现形式的部分平面图;
图9是示出了近端锯齿的本发明的替代实施例的透视图;
图10是本发明的替代实施例的平面图;以及
图11是本发明的替代实施例的平面图。
具体实施方式
在详细阐述本发明之前,应该指出的是,实施例的应用或使用并不局限于附图和具体实施方式中详细示出的部件的构造和布置。示例性实施例可以单独实施,或与其他实施例、变更形式和修改形式结合实施,并可以多种方式实施或执行。例如,以下公开的外科器械和超声刀构造仅为示例性的,而并非旨在限制它们的范围或应用。此外,除非另外指明,否则本文所用的术语和公式是为了方便读者而对示例性实施例进行描述目的所选的,并非限制其范围。
各实施例总体上涉及用于外科器械中的超声外科刀片,更具体地讲,涉及具有改进的切割和凝结特征的超声外科刀片。由于其切割和凝结特性,根据各实施例的超声刀在整形手术方面有着特定的有益效果等,在整形手术中为了将肌肉组织从骨骼上去除,希望在控制出血的同时去除诸如软骨的硬组织和/或组织。根据各实施例的超声刀可减少使用者在将肌肉从骨骼上去除所需的力,并且在一个实施例中,可用于同时止血密封或烧灼组织。减小操作外科器械所需的力可减小使用者疲劳,提高精确性和减小不期望的组织损伤。
但是,所述超声刀还可用于普通的软组织切割和凝结(例如,在诸如隆胸或缩胸的整形手术中)。对于外科医生来说,软组织常常难以悬挂和张紧,从而可有效地施加超声工具压力以实现有效的切割行为。本发明的各实施例允许外科医生抵靠超声刀的刀刃抓住并有效地张紧组织。
根据各种实施例的超声刀可用于脊椎外科手术,特别是在从骨骼上去除肌肉时帮助从背部进入。本发明所公开的多种不同的超声刀构型对于开腹和腹腔镜两种应用非常有用。
超声外科器械的例子在美国专利No.5,322,055和No.5,954,736中公开,其与例如美国专利No.6,278,218B1、No.6,283,981B1、No.6,309,400B2、No.6,325,811B1和No.6,423,082B1,以及共同所有、共同待审的美国专利申请No.11/726,625(名称为“超声外科器械”(Ultrasonic Surgical Instruments),提交于2007年3月22日)和No.11/998,543(名称为“超声外科器械刀片”(Ultrasonic Surgical Instrument Blades),提交于2007年11月30日)中公开的超声刀和外科器械相结合。
现在描述某些示例性实施例,以得到对本文所公开的装置和方法的结构、功能、制造和使用的原理的全面理解。这些实施例的一个或多个实例在附图中示出。本领域的普通技术人员将会理解,本文特别描述和在附图中示出的器械和方法为非限制性的示例性实施例,并且多个实施例的范围仅由权利要求书限定。此外,应当理解,下述实施例、实施例表达、实例等中的任何一个或多个可与下述其他实施例、实施例表达、实例等中的任何一个或多个结合。这种修改形式和变化形式旨在包括在权利要求书的范围之内。
图1示出了超声***10的一个代表性实施例。超声***10的一个实施例包括耦合到超声换能器14的超声信号发生器12、包括手柄壳体16的手柄组件60以及端部执行器50。超声换能器14(称为“Langevin叠堆”)通常包括换能部分18、第一共振器或端罩20、第二共振器或前罩22以及辅助部件。超声换能器14的长度优选地为二分之一***波长的整数倍(nλ/2),如下文将详细描述的。声波组件24包括超声换能器14、安装座26、速率变换器28和表面30。这样的超声***10的构造很好地记录在先前以引用方式并入的参考文献中,并且是本领域技术人员所熟知的,因此其细节将参见这些记录并且不在本文中展开。
应当理解,本文使用的术语“近端”和“远端”是相对于握住手柄组件60的临床医生而言的。因此,端部执行器50相对于较近的手柄组件60而言处于远端。还应该理解,为方便和清晰起见,本文根据临床医生握住手柄组件60来使用诸如“顶部”和“底部”的空间术语。然而,外科器械在多个取向和位置使用,并且这些术语并非意图进行限制,也并非绝对。
参照图2,仅作为示例,将根据在美国专利No.6,423,082B1中公开的超声刀来描述本发明,并且并非意图进行限制,也并非绝对。美国专利6,423,082公开了一种超声外科刀片110,其包括顶表面、底表面和刀刃136。超声刀110是一种平衡弯曲超声刀,其中其纵向运动大于其总运动(包括横向运动)的97%。刀刃136由介于顶表面和底表面之间的切割表面限定,并且顶表面的宽度大于底表面的宽度。超声刀可以是直的或弯曲的。在本发明的一个实施例中,切割表面的至少一部分基本平行于顶表面的至少一部分。在本发明的另一实施例中,第一和第二侧壁与顶表面相交以形成可能锋利或钝的第一和第二刀刃。作为替代,第二刀刃138可由介于顶表面和底表面之间的第二切割表面限定。根据中间的切割表面和顶表面之间的角度,刀刃可以是锋利或钝的。
参照图3,其示出了本发明的第一实施例的第一表现形式。图2的现有技术超声刀被修改为在锋利刀刃136上具有多个锋利点140。锋利点140随着超声刀被按压进入或顶着组织而与组织产生高压接触点。锋利点140由切割半径限定,切割半径继而确定相邻锋利点之间的间距。小切割半径在给定距离内限定更加锋利的点140,大切割半径在给定距离内限定较不锋利的点140。切割半径可从约0.010英寸变化至约0.060英寸。作为另外一种选择,一个锋利点140与另一个锋利点的切割半径可不同。
锋利点140引发解剖线,其允许使用者精确地切割而不管组织是何类型。锋利点140可存在于一条锋利刀刃136上,或者作为另外一种选择,锋利点140可存在于锋利刀刃136和138二者上。此外,图示锋利点140位于超声外科刀片110的远端;但是,超声刀110可被修改为在锋利刀刃136和/或138的近端或中部包括锋利点140。此外,锋利点140可沿着锋利刀刃136和/或138的整个长度存在。
现在参照图4-7,其示出了本发明的第一实施例的第二表现形式。图示为与斜刀刃146a-c结合的锋利点142a-c。斜刀刃由相对于超声刀110的法平面的斜面角度以及斜面的切割半径限定。本领域技术人员应当理解,斜面角度可为大于0°至90°。图3的实施例示出了没有斜面的锋利点,因此斜面角度为0°。优选地,在实施例的这个表现形式中,斜面角度为约35°至约50°,并且更优选地至约40°。切割半径可在约0.010英寸至约0.060英寸之间变化,更优选地在约0.020英寸至约0.050英寸之间变化。
如图4中所示,锋利点142a为斜刀刃146a和146b之间共有;锋利点142b为斜刀刃146b和146c之间共有;锋利点142c仅为斜刀刃146c所有。斜刀刃146a-c可存在于一个锋利刀刃136上,或者作为另外一种选择,斜刀刃146a-c可存在于锋利刀刃136和138二者上。此外,图示斜刀刃146a-c位于超声外科刀片110的远端;但是,超声刀110可被修改为在锋利刀刃136和/或138的近端或中部包括斜刀刃146a-c。此外,斜刀刃146a-c可沿着锋利刀刃136和/或138的整个长度存在。此外,仅为了进行示意性的说明示出了锋利点142a-c和斜刀刃146a-c的数量,而并非意图按任何方式限制本发明的范围。意料之外的是,发明人发现包括锋利点和斜刀刃二者的超声刀在切割软组织和硬组织二者时性能提高。这些超声刀相对于那些相同但不具有锋利点和斜面的超声刀显示出提高的切割效率。在软组织(例如脂肪和皮肤)中,锋利点和/或斜面特征使得能够通过超声刀几何形状直接施加张力于组织,而不是只依赖组织的二次张紧。在软骨中,所述点允许超声刀引发切口并且允许斜刀刃完成切割。
在当前表现形式的替代表现形式中,锋利点142a-c和斜刀刃146a-c具有硬化的表面涂层。这样的涂层可为提交于2007年11月30日的名称为“超声外科刀片”(Ultrasonic Surgical Blades)的共同所有、共同待审的美国临时专利申请61/004,961中所公开的那种,该申请的内容以引用方式全文并入本文。
现在参见图8,其示出了第一实施例的第三表现形式,其中斜刀刃不共享锋利点,而是斜刀刃148a-c通过刀刃间距150a-b隔开。刀刃间距150a-b根据应用而变化,但是在一个示例性实施例中,刀刃间距150a-c为约0.001英寸至约0.10英寸。此外,刀刃间距150a-c不一定是常数,而是在距离上可以变化。
斜刀刃148a-c和刀刃间距150a-b可存在于一个锋利刀刃136上,或者作为另外一种选择,斜刀刃148a-c和刀刃间距150a-c可存在于锋利刀刃136和138二者上。此外,图示斜刀刃148a-c和刀刃间距150a-b位于超声外科刀片110的远端;但是,超声刀110可被修改为在锋利刀刃136和/或138的近端或中部包括斜刀刃148a-c和刀刃间距150a-b。此外,斜刀刃148a-c和刀刃间距150a-b可沿着锋利刀刃136和/或138的整个长度存在。
图9公开了本发明的替代实施例。超声外科刀片210公开了包括顶表面、底表面以及刀刃236和238的端部执行器250。端部执行器250限定了类似勺子的形状,其在远端具有窄的宽度尺寸,在近端具有窄的宽度,并且在近端和远端之间具有大于近端或远端处的宽度尺寸的宽度。
示出的是与斜刀刃248a-c结合的锋利点242a-c。斜刀刃由相对于超声刀210的法平面的斜面角度和斜面的切割半径限定。本领域技术人员应当理解,斜面角度可为大于0°至90°。图9的实施例示出了没有斜面的锋利点,因此,斜面角度为0°。作为另外一种选择,斜面角度可为约35°至约50°。切割半径可在约0.010英寸至约0.060英寸之间变化,更优选地在约0.020英寸至约0.050英寸之间变化。
斜刀刃248a-c可存在于一个锋利刀刃236上,或者作为另外一种选择,斜刀刃248a-c可存在于锋利刀刃236和238二者上。此外,图示斜刀刃248a-c位于超声端部执行器250的近端;但是,端部执行器250可被修改为在锋利刀刃236和/或238的远端或中部包括斜刀刃248a-c。此外,斜刀刃248a-c可沿着锋利刀刃236和/或238的整个长度存在。
图10示出了本发明的替代实施例。超声外科刀片310公开了包括顶表面、底表面以及刀刃336和338的端部执行器350。端部执行器350限定了具有刀刃342的弓形远端340。在远端340与刀刃336和338之间有斜刀刃348a-b和锋利点342a-d。斜刀刃由相对于超声刀310的法平面的斜面角度和斜面的切割半径限定。本领域技术人员应当理解,斜面角度可为0°至90°。
图11示出了本发明的替代实施例。超声外科刀片410公开了包括顶表面、底表面以及刀刃436和438的端部执行器450。端部执行器450限定了具有刀刃442的弓形远端440。在刀刃440与刀刃436和438之间有锋利点442a-b。
尽管已经通过描述若干实施例说明了本发明,但申请人并非旨在将所附权利要求书的精神和范围限定或限制到这些细节上。在不脱离本发明的范围的条件下,本领域的技术人员可以进行许多变型、更改和替代。此外,作为另外一种选择,可将与本发明相关的每一个元件的结构描述为用于提供由该元件进行的功能的方式。因此,本发明旨在仅受随附权利要求书的精神和范围的限制。
Claims (23)
1.一种超声外科刀片,包括:
a.主体,其具有外表面、能够通过施加于其上的振动相对于纵向轴线移动的远端以及具有远侧部分和近侧部分的刀刃,其中所述刀刃的至少一部分包括锋利点。
2.根据权利要求1所述的超声外科刀片,其中所述锋利点位于所述远侧部分。
3.根据权利要求1所述的超声外科刀片,其中所述锋利点位于所述近侧部分。
4.根据权利要求1所述的超声外科刀片,其中所述刀片包括具有远侧部分和近侧部分的第二刀刃,其中所述第二刀刃的至少一部分包括锋利点。
5.根据权利要求1所述的超声外科刀片,其中所述刀刃是直的。
6.根据权利要求1所述的超声外科刀片,其中所述刀刃是弯曲的。
7.根据权利要求1所述的超声外科刀片,其中所述刀刃由第一表面和第二表面限定,在所述第一表面和所述第二表面之间限定角度。
8.根据权利要求1所述的超声外科刀片,其中所述远端限定斜切割表面。
9.一种超声外科刀片,包括:
a.主体,其具有外表面、能够通过施加到其上的振动相对于纵向轴线移动的远端以及具有远侧部分和近侧部分的刀刃,其中所述刀刃的至少一部分包括斜表面。
10.根据权利要求9所述的超声外科刀片,其中所述斜表面位于所述远侧部分。
11.根据权利要求9所述的超声外科刀片,其中所述斜表面位于所述近侧部分。
12.根据权利要求9所述的超声外科刀片,其中所述刀片包括具有远侧部分和近侧部分的第二刀刃,其中所述第二刀刃的至少一部分包括斜表面。
13.根据权利要求9所述的超声外科刀片,其中所述刀刃是直的。
14.根据权利要求9所述的超声外科刀片,其中所述刀刃是弯曲的。
15.根据权利要求9所述的超声外科刀片,其中所述远端限定斜切割表面。
16.一种超声外科刀片,包括:
a.主体,其具有外表面、能够通过施加到其上的振动相对于纵向轴线移动的远端以及具有远侧部分和近侧部分的刀刃,其中所述刀刃的至少一部分包括锋利点和斜表面。
17.根据权利要求16所述的超声外科刀片,其中所述斜表面和锋利点位于所述远侧部分处。
18.根据权利要求16所述的超声外科刀片,其中所述斜表面和锋利点位于所述近侧部分处。
19.根据权利要求16所述的超声外科刀片,其中所述刀片包括具有远侧部分和近侧部分的第二刀刃,其中所述第二刀刃的至少一部分包括斜表面。
20.根据权利要求16所述的超声外科刀片,其中所述刀刃是直的。
21.根据权利要求16所述的超声外科刀片,其中所述刀刃是弯曲的。
22.根据权利要求19所述的超声外科刀片,其中所述第二刀刃包括锋利点。
23.根据权利要求16所述的超声外科刀片,其中所述远端限定斜切割表面。
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WO2017211210A1 (zh) * | 2016-06-08 | 2017-12-14 | 江苏水木天蓬科技有限公司 | 一种超声骨刀刀头 |
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WO2019076086A1 (zh) * | 2017-10-19 | 2019-04-25 | 以诺康医疗科技(苏州)有限公司 | 一种超声波手术刀头、刀杆及超声波手术刀 |
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JP2012501735A (ja) | 2012-01-26 |
AU2009288258A1 (en) | 2010-03-11 |
WO2010027888A1 (en) | 2010-03-11 |
CA2734501A1 (en) | 2010-03-11 |
EP2334244A1 (en) | 2011-06-22 |
JP5539358B2 (ja) | 2014-07-02 |
US20100057118A1 (en) | 2010-03-04 |
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