CN101674779B - 超声外科器械及其软骨和骨成型刀片 - Google Patents
超声外科器械及其软骨和骨成型刀片 Download PDFInfo
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Abstract
一种超声外科刀片，其包括具有治疗区域的刀片主体。在刀片主体的治疗区域中可以形成有至少一个缺口，其中每个缺口与刀片主体的外表面形成组织切割边缘。缺口可以包括一个或多个孔、内腔、凹槽、凹坑或这种结构的组合。在多种实施方式中，一个或多个抽吸内腔被设置在外科刀片中并最终与超声外科器械的抽吸内腔或通道相连通。
Description
相关申请的交叉引用
本申请与下述共同拥有的与本申请同时提交的美国专利申请相关，所述申请整体通过引用包含于此：
(1)美国专利申请序列号为11/726,620，题为SURGICALINSTRUMENTS，代理人案件目录编号为060877/END6050USNP；
(2)美国专利申请序列号为11/726,625，题为ULTRASONICSURGICAL INSTRUMENTS，代理人案件目录编号为060878/END6051USNP；以及
(3)美国专利申请序列号为11/726,760，题为SURGICALINSTRUMENTS，代理人案件目录编号为060879/END6052USNP。
技术领域
本发明整体涉及超声外科器械，且更特别地涉及被配置用于去除骨和/或使软骨成型的超声外科器械和刀片。
背景技术
在多种整形外科手术中，通常需要去除小层的皮质骨。已经开发出几种不同的工具以完成这一任务以及准备骨表面和/或使骨表面成型。例如，通常使用槌子来向诸如凿子的医疗工具施加冲击力以去除骨片。虽然槌子略有效用，但冲击力必须被小心地施加以防止去除过量的骨或者不注意地错误地去除骨片。此外，施加到凿子上的力必须以足够准确的方式施加，以避免对邻近组织和/或器官的损坏。
同样已经开发了被称为骨钻的其他外科工具用于去除皮质骨层以及使骨和软骨成型。但是，这些装置一般必须非常精确地使用以保证只去除需要量的骨且周围组织没有被不合需要地损坏或损伤。但是，这些骨钻和类似器械不能提供控制出血的措施且容易给治疗组织留下粗糙表面。基于无线电频率的装置被开发以致力于解决这些问题。
基于无线电频率的装置使得外科医生能够在去除、调整或雕刻软组织的同时密封住血管。它们特别适用于主要由胶原构成且遇热收缩的结缔组织。但是，这些基于无线电频率的装置可能造成不合需要的组织深度热损伤。
已开发的用于有效地切割和凝结器官组织的其他器械使用以超声频率被传递至外科端部执行器的机械振动。当超声振动被以合适的能量水平以及使用合适的端部执行器传递至器官组织时，超声振动能被用于切割、解剖、抬升或凝结组织或者从骨上剥离肌肉组织。由于能够从超声换能器通过波导管传递至外科端部执行器的超声能量的量，使用实心技术的超声器械是特别有利的。
以超声频率将这类器械的端部执行器(例如切割刀片)激活或激发导致在邻近组织内产生局部发热的纵向振动，帮助切割和凝结。由于超声器械的本质，特定的超声致动的端部执行器可以被设计为执行包括诸如切割和凝结的多种功能。
由例如对换能器进行电激发而导致在外科端部执行器中形成超声振动。换能器可以由器械手持件中的一个或多个压电或磁致伸缩元件构成。换能器部分产生的振动通过从换能器部分延伸至外科端部执行器的超声波导管传递到外科端部执行器。波导管和端部执行器被设计为以与换能器同样的频率共振。因此，当端部执行器被连接到换能器时，整个系统的频率与换能器自身的频率一致。然而，本领域技术人员将理解，系统可以被设计为换能器和刀片以不同的频率共振且当接合时系统以需要的频率共振。
端部执行器的尖端处的纵向超声振动的幅值d表现为以共振频率的简单正弦曲线，如下所示：
d＝A sin(ωt)
其中：
ω为弧度频率，等于循环频率f乘以2π；且
A为零到峰值的幅值。
纵向偏移定义为峰峰(peak-to-peak)幅值，为正弦波幅值的两倍或2A。
多年来已经开发了多种不同的超声刀片配置。倾向于擅长凝结方面(因此将组织变成易于整形的粘性凝结物)的刀片会倾向于不擅长切割。一些这种刀片通常具有球形的主体和基本平滑的外表面。图2和图3示出了过去已经被使用的这类型的球形刀片10。虽然这种刀片设计擅长于凝结方面，但由于其形状并不特别适合骨去除或组织整形应用。其他更适于切割组织的现有刀片没有这么适合于组织凝结和整形。这些问题在只能为目标组织或骨提供有限入口且刀片必须在水相环境下工作的关节镜操作中被进一步加重了。
因此，将有利的是设计一种既能用于使诸如软骨或半月板的软组织成型、又能给骨剥除皮质的超声外科器械。将更加有利的是设计一种既能用于给骨剥除皮质或抽吸、又能帮助组织整形和组织点状凝固的超声外科器械。本发明的多种实施方式包含了对现有超声器械的改进以提供这些有利条件。前述讨论仅意于描述当前本发明领域中存在的一些缺点，而不应被理解为对于权利要求书的范围的否认。
发明内容
在本发明的一个方面，提供了一种包括超声外科刀片的外科器械，超声外科刀片包括具有治疗区域的刀片主体。在多种实施方式中，刀片主体的治疗区域中形成有至少一个缺口，其中每个缺口与刀片主体的外表面形成组织切割边缘。
在本发明的多种实施方式的另一个基本的方面，提供了一种超声外科刀片。在多种实施方式中，刀片具有包括基本为球形的治疗区域的刀片主体。球形治疗区域的至少一部分上可以形成有至少一个基本锋利的边缘。
在本发明的多种实施方式的又一个基本的方面，提供了一种包括具有近端、远端的超声传递构件的超声外科器械以及连接到传递构件远端的超声致动刀片。在多种实施方式中，刀片具有刀片主体，刀片主体具有治疗区域。刀片主体的治疗区域中可以形成有至少一个缺口。每个缺口与刀片主体的外表面形成组织切割边缘。
根据附图及其描述，本发明的这些以及其他目的和优点将得以清楚。
附图说明
本发明的多种实施方式的新颖特征在后附的权利要求书中被特别陈述。但是，结合附图参照下述描述能够最大程度地理解本发明的多种实施方式的组织和操作方法及其进一步的目的和优点，附图中：
图1为本发明的多种实施方式的外科器械的部分剖视图；
图2为现有超声外科刀片的一部分的部分透视图；
图3为图2中示出的现有刀片的远端的正视图；
图4为本发明的超声外科刀片实施方式的一部分的透视图；
图5为图4中的超声外科刀片的远端的正视图；
图6为沿着图5中的线6-6截取的图4和图5中示出的超声外科刀片的一部分的剖视图；
图7为本发明的另一种超声外科刀片实施方式的一部分的透视图；
图8为图7的超声外科刀片的远端的正视图；
图9为沿着图8中的线9-9截取的图7和图8中示出的超声外科刀片的部分的剖视图；
图10为本发明的另一种超声外科刀片实施方式的一部分的透视图；
图11为图10的超声外科刀片的远端的正视图；
图12为沿着图11中的线12-12截取的图10和图11中示出的超声外科刀片的部分的剖视图；
图13为本发明的另一种超声外科刀片实施方式的一部分的透视图；
图14为图13的超声外科刀片的远端的正视图；
图15为沿着图14中的线15-15截取的图13和图14中示出的超声外科刀片的一部分的剖视图；
图16为本发明的另一种超声外科刀片实施方式的一部分的透视图；
图17为图16的超声外科刀片的俯视图；
图18为本发明的另一种超声外科刀片实施方式的一部分的透视图；
图19为图18的超声外科刀片的远端的正视图；
图20为沿着图19中的线20-20截取的图18和图19中示出的超声外科刀片的部分的剖视图；
图21为本发明的另一种超声外科刀片实施方式的一部分的透视图；
图22为图21的超声外科刀片的所述部分的俯视图；
图23为本发明的另一种超声外科刀片实施方式的一部分的俯视图；
图24为图23的超声外科刀片的远端的正视图。
具体实施方式
在具体解释本发明之前，应当注意本发明的应用或使用并不限于附图和说明书中所描述的零件的构造和布置的细节。本发明的说明性的实施方式可以被应用或结合到其他实施方式、变型或改型中，并且可以通过多种方式被实践或实行。例如，下文公开的外科器械和刀片结构仅作为说明性的，而并不意于限制本发明的范围或应用。此外，除非另有指明，这里使用的术语和表达方式是出于描述本发明的说明性的实施方式的目的以便于读者理解而选用的，而不应用于限制本发明的目的。
本发明的多种实施方式整体涉及用于与超声外科器械一起使用的超声外科刀片，且更特别地，涉及用于改进的骨和组织的去除、抽吸和凝结特征的超声外科刀片和器械。根据本发明的多种实施方式的刀片可以在需要在去除皮质骨和/或组织的同时控制出血的整形外科操作中特别有用。公开了可以用于开放式和腹腔镜应用的多种不同的刀片构造。
超声外科器械的示例在专利号为5,322,055和5,954,736的美国专利中公开，与之结合使用的超声刀片和外科器械在例如专利号为6,309,400B2、6,278,218B1、6,283,981B1以及6,325,811B1中公开，上述专利其整体均通过引用包含于此。这些参考文献公开了激发刀片纵向的反节点(anti-node)的超声外科器械设计和刀片设计。由于一个或多个不对称部，这些刀片显示出横向和/或扭转运动，其中这些非纵向运动的“波长”特性小于刀片及其延伸部分的基本纵向运动的“波长”。因此，非纵向运动的波形将沿着其组织执行器提供横向/扭转运动的节点位置，而活动刀片沿着其组织执行器的净运动不为零(即沿着从其远端(纵向运动的一个反节点)到从组织执行器部分向近侧的第一个纵向运动节点位置延伸的长度至少具有纵向运动)。本领域普通技术人员还将理解横向和/或扭转运动的组合与纵向运动结合能够加强切割动作。现在将描述一些示例性的实施方法以提供对于这里所公开的结构、功能、制造以及装置和方法的使用的全面的理解。这些实施方式的一个或多个实例在附图中示出。本领域普通技术人员将理解，这里明确描述以及在附图中具体示出的装置和方法是非限制性的示例性的实施方式，且本发明的多种实施方式的范围仅由权利要求书限定。根据一种示例性的实施方式来说明或描述的特征可以与其他实施方式的特征相结合。这些变型和改型均意于被包含在本发明的范围内。
图1示出了根据本发明的超声系统10，超声系统10包括具有超声换能器14的超声信号发生器12、手持件壳体16和刀片100。一般被称为“朗之万堆叠(Langevin stack)”的超声换能器14通常包括换能部分18、第一共振器或末端盖20、第二共振器或前端盖22以及辅助组件。如后文将更具体描述地，超声换能器14的长度优选为二分之一系统波长的整数倍(nλ/2)。声学部件24包括超声换能器14、底座26、速度转换器28以及表面30。
末端盖20的远端与换能部分18的近端连接，且前端盖22的近端与换能部分18的远端连接。前端盖22和末端盖20的长度根据若干变量确定，这些变量包括换能部分18的厚度、用于制造末端盖20和前端盖22的材料的密度和弹性模量以及超声换能器14的共振频率。前端盖22可以从其近端到远端向内渐缩以像速度转换器28一样增大超声振动的幅值，或者可选地可以不进行增幅。
换能器可以由器械手持件中的一个或多个压电或磁致伸缩元件构建。通过例如对可由器械手持件中的一个或多个压电或磁致伸缩元件构建的换能器进行电激励而导致外科端部执行器中形成超声振动。换能器部分产生的振动被通过从换能器部分延伸至外科端部执行器的超声波导管传递至外科端部执行器。
在示出的实施方式中，换能器由压电元件40构建。压电元件40可以由诸如锆-钛酸铅、偏铌酸铅、钛酸铅或其他压电晶体材料的任何合适的材料制成。正极42、负极44和压电晶体40均具有穿过中心延伸的孔。正极42和负极44分别与导线46和导线48电联接。导线46和导线48被包装在线缆50中并且可以与超声系统10的超声信号发生器12电连接。
声学部件24的超声换能器14将来自超声信号发生器12的电信号转换成主要导致超声换能器14和刀片100以超声频率纵向振动的机械能量。合适的信号发生器可以使用俄亥俄州辛辛那提市EthiconEndo-Surgery，Inc.的型号GEN04。当声学部件24被供电，声学部件24中产生振动驻波。沿着声学部件24任意点的振动幅值可以取决于沿着声学部件24测量振动的位置。振动驻波中最小或为零的交叉处一般被称为节点(node)(即移动通常是最小处)，而驻波中绝对值最大或峰值处一般被称为反节点(anti-node)。反节点和最近的节点之间的距离为四分之一波长(λ/4)。
导线46和导线48将电信号从超声信号发生器12传递至正极42和负极44。为了响应脚开关60，超声信号发生器12提供电信号给压电晶体40供电以在声学部件24中产生声学驻波。电信号导致压电晶体40以反复微小位移的形式进行扰动，从而导致材料内大的压缩力。反复微小位移导致压电晶体40沿着电压梯度的轴线以连续方式扩张和收缩，产生超声能量的纵向波。超声能量通过声学部件25被传递至刀片100。
声学部件24为了将能量传递给刀片100，声学部件24的所有组件必须与刀片100声学联接。超声换能器14的远端可以在表面30处通过诸如双头螺栓90的螺纹连接与超声波导管80的近端声学联接。
声学部件24的组件优选为被声学调整，使得任何组件的长度为二分之一波长的整数倍(nλ/2)，其中波长λ为声学部件24的预选的或操作的纵向振动驱动频率fd的波长，n为任意正整数。也可以想到声学部件24可以包含任何适合的声学元件布置。
此外，可以提供诸如晶体乳化器的抽吸换能器，在换能器中包括中央内腔以允许穿过换能器的后部抽吸组织和流体。中央内腔可以被穿过切口插入并且超声振动以使组织液体化。被乳化的组织经由内腔、穿过换能器的后部通过抽吸被去除。现代的抽吸器也执行冲洗。这些抽吸/冲洗器械具有双通道或内腔，一条用于冲洗而另一条用于抽吸。通道通常是同轴的，内通道由刚性或半刚性套管构成，而外通道具有由可以为弹性的套筒构成的远侧部分。末端的一个或多个组件可以从器械的手持件去除以选择适合的或需要的末端，以及用于末端的替换。
图4至图6示出了本发明的一种可以与上述超声器械10一起使用的超声外科刀片的实施方式。但是，虽然继续进行具体描述，本领域普通技术人员将理解，在不脱离本发明的精神和范围的条件下，这里公开的多种超声外科刀片的实施方式及其任何等同结构都是可想到地能够与其他现有超声外科器械一起有效地使用。因此，对这里公开的多种超声外科刀片的实施方式的保护不应被限制于仅与上述示例性的超声外科器械一起使用的情况。
如图4至图6中可以看到，超声外科刀片100具有刀片主体110，刀片主体110具有非常适于组织凝结和整形应用的基本平滑的外表面122。由于能够将超声激活的大且钝的表面抵靠在组织上，平滑的外表面非常适于组织凝结。这允许在没有切割的风险下进行热传递，允许组织形成密封血管的粘性凝结物。刀片110可以由诸如Ti6Al4V(一种包括铝和钒的钛合金)、铝、不锈钢或其他现有材料的适于传递超声能量的材料制成。刀片主体110可以包括一般由120标示的基本为球形的治疗区域，以及从治疗区域120的近侧部分121伸出的颈部或过渡部分130。如上文所指出，颈部130可以通过诸如双头螺栓、焊接、胶粘或其他现有方法连接到波导管80。在可选的实施方式中，颈部130和波导管80可以包括单个单元。超声波导管80可以具有例如基本等于二分之一系统波长(λ/2)的整数倍的长度。超声波导管80可以优选地由实心轴制成，由诸如钛合金(即Ti-6Al-4V)或例如铝合金的能够有效地传递超声能量的材料构建。超声波导管80也可以被配置为如本领域已知地将传递至超声刀片100的机械振动增幅。
在可选的实施方式中，超声传递波导管可以被制造为空心的。在其他的实施方式中，超声外科刀片可以包括保护患者组织不受超声传递波导管影响的外护套。在这种实施方式中，可以在外护套和外科刀片之间纵向延伸的空间内提供内腔。内腔可以被用于穿过位于刀片和外护套之间的内腔来冲洗或抽吸组织。
超声刀片100可以具有基本等于二分之一系统波长(λ/2)的整数倍的长度。超声刀片100的远端被设置在靠近反节点处以提供远端最大的纵向偏移。当换能器部件被供电，超声刀片100的远端124可以被配置为在例如约10至150微米的峰峰值的范围内、且优选为在约30至100微米的范围内以预定的55.5kHz的振动频率移动。超声刀片100可以被配置为以一个幅值以形成在2米/秒至30米/秒之间的刀片速度的特定频率振动。
虽然本示例性的实施方式中治疗区域基本为球形，本领域普通技术人员将理解，刀片主体110可以具有提供基本平滑且倒圆的外周边的其他形状。例如，刀片主体可以包括具有倒圆的远端的略呈细长圆柱体状的构件。
如图1，在多种实施方式中，抽吸内腔140可以被设置成穿过治疗区域120和颈部130并且可以被配置为最终与独立的抽吸/冲洗模块、安装到塔的抽吸模块90和/或冲洗模块92(图1)或例如手术室中的整体式超声发生器/抽吸/冲洗模块连通。同样有利的是将抽吸/冲洗控制器(如喇叭形阀等)和选择抽吸或冲洗功能的工具集成在装置手柄中。
如图4和图6所示，抽吸内腔140可以在治疗区域120的远端124形成开口150。在多种实施方式中，开口150由形成于治疗区域120的外表面122中的组织切割边缘152限定。切割边缘152可以被用于组织切割和整形并且也可以作为用于去除皮质骨的支撑面或边缘。当组织和/或骨材料被切割边缘152切除或取出时，材料可以通过外科器械中的内腔140和抽吸通道从手术部位中去除。在至少一种实施方式中，球形治疗区域110和相对平滑周边的外表面122非常适于组织凝结和整形。更特别地，由于基本为球形的外表面122，表面122能够被用于在例如不切割组织的条件下加热和处理组织，使得当组织冷却时能够保持被重新配置的形状。边缘152也可以给外科医生提供用于组织切割和成型以及去除小片骨的工具，这代表着在现有球形超声刀片上的一大改进。本实施方式也提供能够抽吸手术部位并从中去除组织和小片骨的附加的特征。
图7至图9示出了本发明的另一种超声外科刀片200。图中可以看出，刀片200具有刀片主体210，刀片主体210具有相对平滑的外表面222并且可以由任何前述材料制成。刀片主体210可以包括一般由220标示的基本为球形的治疗区域，以及从治疗区域220的近侧部分221伸出的颈部或过渡部分230。颈部230可以通过诸如双头螺栓、焊接、胶粘或其他现有方法来连接至波导管(未示出)。在可选的实施方式中，颈部230和波导管可以包括单个单元。
在多种实施方式中，抽吸内腔240可以被设置成穿过治疗区域220和颈部230并且最终与独立的抽吸/冲洗模块、安装到塔的抽吸模块90和/或冲洗模块92(图1)或例如手术室中的整体式超声发生器/抽吸/冲洗模块连通。本领域普通技术人员将理解抽吸模块可以被使用来从手术部位吸走组织或流体，而冲洗模块可以被用来向手术部位提供冲洗流体。在本实施方式中，抽吸内腔240具有在治疗区域220的远端224形成开口250的渐缩部分242。开口250由形成于治疗区域220的外表面222中的组织切割边缘252限定，切割边缘252可以被用于组织形成和整形，且也可以辅助皮质骨的去除。在多种实施方式中，边缘252可以是相对锋利的以辅助组织和/或骨的去除。当组织和/或骨材料被切除或取出时，可以通过抽吸内腔250从手术部位去除。渐缩部分的一个优点是它首先允许球面上的锐角，形成比直孔更加锋利的边缘。此外，渐缩部分242使得切割孔变窄以最小化切割产生的微粒的尺寸。这增加了微粒的尺寸比中央内腔小的可能性并且因此使得微粒被堵在内腔中的可能性最小化。
在可选的实施方式中，渐缩部分242可以由具有与制造刀片主体210的材料的一种/多种性质不同的一种或多种性质的材料制造。例如，这种渐缩部分242可以被压入内腔240和/或通过焊接、螺纹或其它适合的固定方法安装在适合的位置。在多种实施方式中，可以基于抗拉强度、疲劳强度和/或保持边缘的能力或其他需要的性质来选择第二种材料。
图10至图12示出了本发明的另一种超声外科刀片300。图中可以看出，刀片300具有刀片主体310，刀片主体具有相对平滑的外表面322并且可以由任何前述材料制成。刀片主体310可以包括一般由320标示的基本为球形的治疗区域。颈部或过渡部分330从治疗区域320的近侧部分321伸出。颈部330可以通过诸如双头螺栓、焊接、胶粘或其他现有方法来连接到波导管(未示出)。在可选的实施方式中，颈部330和波导管可以包括单个单元。
在多种实施方式中，第一抽吸内腔340可以沿着纵向轴线A-A被设置在治疗区域320和颈部330中并且最终与独立的抽吸/冲洗模块、安装到塔的抽吸模块90和/或冲洗模块92(图1)或例如手术室中的整体式超声发生器/抽吸/冲洗模块连通。在本实施方式中，第一抽吸内腔340与治疗区域320中的沿着与轴线A-A交叉的轴线B-B的第二抽吸内腔342交叉。在多种实施方式中，轴线B-B可以基本垂直于轴线A-A，如图10和图12所示。第二抽吸内腔342可以在治疗区域320中形成两个径向相对的开口344、346。在本实施方式中，开口344由边缘345限定而开口346由边缘347限定。边缘345、347可以被用于组织形成和整形，且也可以辅助皮质骨的去除。在多种实施方式中，一个或两个边缘345、347可以是相对锋利的以辅助组织和/或骨的去除。当组织和/或骨材料被边缘345切割或取出时，材料可以通过内腔340和342从手术部位去除。在可选的实施方式中，一个或两个开口344、345可以形成前述布置的渐缩部分。
图13至图15描述了本发明的另一种超声外科刀片400。图中可以看出，刀片400具有刀片主体401，刀片主体具有相对平滑的外表面422且可以有任何前述材料制成。刀片主体410可以包括一般由420标示的基本为球形的治疗区域。在本实施方式中，沿着治疗区域420的周边设置有环状的凹槽450。凹槽450可以如图所示具有倒圆的底部或者可以具有尖的底部或方形的底部等。在示出的实施方式中，周向延伸的环形凹槽450在基本平滑的外表面422中形成了两个平行边缘452、454用于组织切割和成型以及用于提供去除骨和组织的支撑面。颈部或过渡部分430可以从治疗区域420的近侧部分421伸出。颈部430可以通过诸如双头螺栓、焊接、粘接或其他现有方法连接到波导管(未示出)。在可选的实施方式中，颈部430和波导管可以包括单个单元。
在多种实施方式中，抽吸内腔440可以被设置在治疗区域420和颈部430中并且最终与独立的抽吸/冲洗模块、安装到塔的抽吸模块90和/或冲洗模块92(图1)或例如手术室中的整体式超声发生器/抽吸/冲洗模块连通。在本实施方式中，至少一个(但优选为两个)交叉内腔442、444可以从内腔440的闭合端441以径向相对的方向延伸并且如图所示地通向环形凹槽450。当组织和/或骨材料被边缘452切除或取出时，材料可以通过内腔444、442和440从手术部位去除。在图13至图15示出的实施方式中，示出了一条环形凹槽450。在示出的实施方式中，凹槽沿着周边延伸使得凹槽基本垂直于颈部。在其他的实施方式中，一个或多个凹槽可以绕着主体形成使得凹槽不垂直于颈部，即凹槽竖直地延伸。在可选的实施方式中，可以使用多个环形凹槽。在又一些其他的实施方式中，在相对平滑的外表面412上可以提供多个分离的凹槽。这些分离的凹槽可以沿着基本平行的轴线布置，或者可以沿着单个轴线轴向对准。本领域普通技术人员将理解可以使用一个、两个或多于两个的交叉内腔。这些交叉内腔可以通向凹槽或者外表面422以及也可以通向抽吸内腔430。在又一些其他的实施方式中，一个或多个交叉内腔可以通向凹槽，且一个或多个其他的交叉内腔可以经由表面422开口。本领域普通技术人员将理解，在仅使用一个交叉内腔的实施方式中，这种布置可能导致刀片的不平衡，从而产生不合需要的横向运动。在又一些仅使用一个交叉内腔的其他的实施方式中，由于单个交叉内腔导致的“第一”不平衡可以由在刀片的其他部分提供空腔或者类似区域(“第二”不平衡)来抵消，或者可以将交叉内腔制成足够小以使得形成的不平衡最小化。在图16和图17所示的实施方式中，刀片主体400中不设置内腔。
图18至图20示出了本发明的另一种超声外科刀片500。图中可以看出，刀片500具有刀片主体510，刀片主体具有相对平滑的外表面522并且可以由任何前述材料制成。刀片主体510可以包括一般由520标示的基本为球形的治疗区域。在这种实施方式中，在治疗区域中提供至少一个离散的孔550。在图18至图20所示出的实施方式中，示出了四个孔550。在多种实施方式中，孔550的数量和布置可以变化。每个孔550可以在治疗区域520上形成开口552，开口552在外表面422上形成可以用于组织形成和整形以及辅助皮质骨的去除的组织切割边缘544。孔550可以如图所示具有平的底部555，或者底部可以是倒圆的、尖形的等。一个或多个孔550可以具有渐缩部分551以进一步帮助形成锋利的边缘554。在示出的实施方式中，从治疗区域520的近侧部分521可伸出颈部或过渡部分530。颈部530可以通过例如双头螺栓、焊接、胶粘或其他现有方法来连接到波导管(未示出)。在可选的实施方式中，颈部530和波导管可以包括单个单元。
图21和图22示出了本发明的另一种超声外科刀片600。如图中可以看出，刀片600具有刀片主体610，刀片主体610具有基本平滑的外表面622且可以由任何上述材料制成。刀片主体610可以包括基本为球形的治疗区域，一般由620标示出。在本实施方式中，治疗区域620中设置有至少一个凹坑。在图21和图22所示的实施方式中，示出了四个凹坑650。在多种实施方式中，凹坑650的数量和布置可以变化。每个凹坑650可以在外表面622中形成组织切割边缘652，用于组织切割和整形以及辅助皮质骨的去除。在示出的实施方式中，从治疗区域620的近侧部分伸出颈部或过渡部分630。颈部630可以通过例如双头螺栓、焊接、胶粘或其他现有方法来连接到波导管(未示出)。在可选的实施方式中，颈部630和波导管可以包括单个单元。
图23和图24示出了本发明的另一种超声外科刀片700。如图中可以看出，刀片700具有刀片主体710，刀片主体710具有倒圆的远端712以及由侧表面718隔开的两个相对平的表面714和716。刀片700可以由任何前述材料制成。主体710可以包括一般由720标示出的治疗区域。在本实施方式中，主体710的侧面718中设置有至少一个孔750。在图23和图24所示的实施方式中，示出了三个孔750。在多种实施方式中，孔750的数量和布置可以变化。每个孔750可以在主体部分710中形成开口752，开口752形成组织切割边缘752，用于组织切割和整形以及辅助皮质骨的去除。在一种实施方式中，孔750可以与中央内腔流体连通以用于在切割过程中的组织冲洗和抽吸。孔750可以如图所示具有平的底面，或者底面可以是倒圆的，尖形的等。在示出的实施方式中，从治疗区域720的近侧部分伸出颈部或过渡部分730。颈部730可以通过例如双头螺栓、焊接、胶粘或其他现有方法来连接到波导管(未示出)。在可选的实施方式中，颈部730和波导管可以包括单个单元。
在这里所描述的本发明的多种实施方式及其等同结构代表了在现有超声外科刀片技术上的改进。例如这里公开的几种实施方式包括形状基本为球形的治疗区域，且治疗区域具有相对平滑外表面，可以有利地被用于组织凝结和整形。此外，这里公开的几种实施方式具有形成于其治疗区域内的一个或多个组织切割边缘，可以被用于组织切割和剔除，并且也可以当以传统方式(槌子等)向器械施加冲击力时起用于接合和去除部分皮质骨的支撑面的作用。这些边缘可以有利地用锉刀或其他传统锐化工具磨锐，或者如果需要的话边缘也可以是相对较钝的。已经公开了多种不同的结构来在主体部分的平滑的外表面上形成边缘。边缘一般由主体部分的外表面内的缺口形成。如背景中所使用的，术语“缺口”可以包括诸如离散的孔(即不完全穿过主体的任何部分的孔)、在主体部分的外表面内形成开口的内腔或通道、凹坑和/或这些缺口的任意组合。在不脱离本发明的精神和范围的条件下，并且只要保持所需数量的相对平滑的外表面以用于组织凝结和成型，也可以改变这种“缺口”的数量和方向。
因此，根据前文可以理解，本发明的多种实施方式提供了用于去除皮质骨的更快捷和更加精确的方法。这些布置也比现有的骨去除方法需要更小的力以去除骨。此外，本发明的多种实施方式独特而新颖的特征也能在不使用可能对组织造成深度热损伤的基于无线电频率的工具的情况下帮助定位组织凝结。
虽然已经描述了本发明的若干实施方式，但是，应当清楚本领域技术人员可以想到实现本发明部分或全部优点的这些实施方式的多种改型、变型和变化。例如，根据多种实施方式，单个组件可以被多个组件替换，例如多个组件可以由单个组件替换，以执行给定的功能。因此在不脱离由后附的权利要求书所限定的本发明的范围和精神的条件下，本申请意于覆盖所有这些改型、变型和变化。
这里公开的刀片和装置可以被设计为在单次使用之后丢弃，或者可以被设计为可多次使用的。但是，在任何一种情况下，在至少一次使用后装置可以通过修整以重新使用。修整可以包括下述步骤的组合：分解装置、然后是对特定元件进行清洁或替换、然后是重新组装。特别地，装置可以被重新组装，且装置的任意数量的特定元件或组件可以以任意组合被选择性地替换或去除。对特定元件进行清洁和/或替换之后，装置可以在修整设施或者医疗组在手术前立即被重新组装以备下次使用。本领域普通技术人员将理解，装置的修整可以使用多种不同的技术来进行分解、清洁/替换以及重新组装。这些技术的应用，以及得到的被修整的装置，都落在本发明的范围内。
优选地，这里所描述的发明将在手术之前进行处理。首先，获取一个新的或用过的器械，并且如果有必要的话进行清洁。然后将器械除菌。在一种除菌技术中，器械被放置在诸如塑料或高密度聚乙烯合成纸(TYVEK
)袋的闭合且密封的容器内。然后将容器和器械放置能够穿透容器的辐射场中，例如伽马射线、x射线或高能量电子。辐射杀死器械上和容器内的细菌。然后无菌的器械可以被储存在无菌的容器内。密封容器可保持器械无菌直至其在医疗设施中被打开。
优选地装置被杀菌。这可以通过包括贝塔或伽马射线、臭氧、蒸汽、高压蒸汽消毒、消毒液浸泡或其他现有方式的本领域已知的任意数量的方法来完成。
通过引用包含于此的任何专利、出版物或其他公开材料其部分或整体仅仅在所包含的材料与现有定义、声明或本公开中所陈述的其他公开材料不冲突的程度上包含于此。这样，在必要的程度上，这里明确陈述的公开取代通过引用包含于此得的任何冲突材料。通过引用包含于此、但是与现有的任何材料或定义、声明或所陈述的其部分冲突的任何材料或其部分仅仅在所包含的材料与现有公开材料之间没有产生不冲突的程度上包含于此。
本发明的保护范围不应解释为限制于所公开的特定的实施方式。因此这些实施方式应当被认为是说明性的而不是限制性的。在不脱离本发明精神的条件下，其他人可以进行变型和改变。因此，明确认定本发明包括如权利要求书中所限定地落在本发明的精神和范围内的所有这些等价物、变型和改变。
Claims (30)
1.一种超声外科刀片，包括：
刀片主体，具有基本为球形的治疗区域；以及
至少一个缺口，形成于所述刀片主体的所述治疗区域内，其中每个所述缺口与所述刀片主体的外表面形成组织切割边缘。
2.如权利要求1所述的超声外科刀片，其中，所述至少一个缺口从包括孔、内腔、凹槽和凹坑的组中选择。
3.如权利要求2所述的超声外科刀片，其中，所述凹槽包括一系列凹槽段。
4.如权利要求1所述的超声外科刀片，其中，所述治疗区域基本为球形。
5.如权利要求1所述的超声外科刀片，其中，所述至少一个缺口包括孔，所述孔具有与所述刀片主体的外表面形成所述组织切割边缘的渐缩部分。
6.如权利要求5所述的超声外科刀片，其中，所述刀片主体由第一材料制成且其中所述渐缩部分由与所述第一材料不同的第二材料制成。
7.如权利要求1所述的超声外科刀片，其中，所述至少一个缺口包括延伸穿过所述刀片主体的内腔，所述内腔形成穿过所述刀片主体的外表面的开口，使得所述开口的周边形成所述组织切割边缘。
8.如权利要求1所述的超声外科刀片，其中，所述至少一个缺口包括延伸穿过所述刀片主体的内腔，所述内腔具有渐缩远端，所述渐缩远端在所述治疗区域形成开口，所述开口与所述刀片主体的所述外表面形成所述组织切割边缘。
9.如权利要求1所述的超声外科刀片，还包括：
颈部，从所述治疗区域的一部分沿着纵向轴线伸出；
第一内腔，穿过所述刀片主体的一部分和所述颈部延伸；以及
至少一个第二内腔，穿过所述刀片主体的另一部分延伸并且与所述第一内腔相交以与第一内腔流体连通，每个所述第二内腔形成穿过所述刀片主体的外表面的至少一个开口，每个所述开口与所述外表面形成组织切割边缘。
10.如权利要求9所述的超声外科刀片，其中，所述至少一个第二内腔形成穿过所述刀片主体的所述外表面的径向相对的开口。
11.如权利要求9所述的超声外科刀片，其中，所述至少一个缺口包括在所述刀片主体的所述外表面中的至少一个凹槽，且其中所述凹槽与至少一个所述开口连通。
12.如权利要求9所述的超声外科刀片，其中，所述至少一个第二内腔沿着与所述纵向轴线基本垂直的轴线延伸。
13.如权利要求1所述的超声外科刀片，其中，所述至少一个缺口包括至少一个内腔，所述至少一个内腔形成于所述刀片主体中并且形成穿过所述刀片主体的外表面的至少一个开口，以使得所述开口的周边形成所述组织切割边缘，所述至少一个内腔在所述刀片主体中形成第一不平衡。
14.如权利要求13所述的超声外科刀片，还包括第二不平衡，所述第二不平衡形成在所述刀片主体中，以抵消所述第一不平衡。
15.如权利要求7所述的超声外科刀片，还包括与所述至少一个内腔连通的抽吸构件。
16.如权利要求7所述的超声外科刀片，其中，所述至少一个内腔与抽吸模块和冲洗模块中的至少一个流体连通。
17.一种超声外科刀片，包括：
刀片主体，具有基本为球形的治疗区域；以及
至少一个基本锋利的边缘，形成在所述球形的治疗区域的至少一部分上。
18.如权利要求17所述的超声外科刀片，其中，所述至少一个基本锋利的边缘包括由所述基本为球形的治疗区域中的凹槽形成的至少一个环形锋利边缘。
19.如权利要求17所述的超声外科刀片，还包括在所述刀片主体中的至少一个内腔通道。
20.如权利要求19所述的超声外科刀片，其中，所述至少一个内腔通道在所述刀片主体中形成不平衡。
21.如权利要求20所述的超声外科刀片，还包括与所述至少一个内腔通道连通的抽吸构件。
22.如权利要求21所述的超声外科刀片，其中，所述至少一个内腔通道与抽吸模块和冲洗模块中的至少一个流体连通。
23.如权利要求20所述的超声外科刀片，其中，所述至少一个内腔通道通入到所述凹槽中。
24.如权利要求17所述的超声外科刀片，还包括至少一个内腔通道，所述至少一个内腔通道在所述基本为球形的治疗区域中，且其中形成有所述至少一个基本锋利的边缘，其中所述内腔通道的渐缩部分穿过所述基本为球形的治疗区域的远端。
25.如权利要求17所述的超声外科刀片，还包括至少一个孔，所述至少一个孔在所述基本为球形的治疗区域中，且其中所述至少一个基本锋利的边缘由所述孔的渐缩部分形成，所述孔穿过所述基本为球形的治疗区域的外表面。
26.一种超声外科器械，其包括：
超声传递构件，具有近端和远端；以及
超声致动刀片，连接到所述超声传递构件的远端，其中刀片包括：
刀片主体，具有基本为球形的治疗区域；以及
至少一个缺口，形成在所述刀片主体的所述治疗区域中，其中每个所述缺口与所述刀片主体的外表面形成组织切割边缘。
27.如权利要求26所述的超声外科器械，其中，所述至少一个缺口从包括孔、内腔、凹槽和凹坑的组中选择。
28.如权利要求26所述的超声外科器械，其中，所述治疗区域基本为球形。
29.如权利要求26所述的超声外科器械，其中，所述超声传递构件能够将纵向运动、横向运动和扭转运动中的至少一种从与其连通的所述纵向运动、横向运动和扭转运动的相应来源传递至所述超声致动刀片。
30.如权利要求29所述的超声外科器械，其中，所述超声传递构件能够将所述纵向运动、横向运动和扭转运动的组合传递至所述超声致动刀片。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US11/726,621 | 2007-03-22 | ||
| US11/726,621 US20080234709A1 (en) | 2007-03-22 | 2007-03-22 | Ultrasonic surgical instrument and cartilage and bone shaping blades therefor |
| PCT/US2008/057325 WO2008118685A1 (en) | 2007-03-22 | 2008-03-18 | Ultrasonic surgical instrument and cartilage and bone shaping blades therefor |
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| Publication Number | Publication Date |
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| CN101674779A CN101674779A (zh) | 2010-03-17 |
| CN101674779B true CN101674779B (zh) | 2012-07-25 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN2008800145376A Expired - Fee Related CN101674779B (zh) | 2007-03-22 | 2008-03-18 | 超声外科器械及其软骨和骨成型刀片 |
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| Country | Link |
|---|---|
| US (3) | US20080234709A1 (zh) |
| EP (1) | EP2131758B1 (zh) |
| JP (1) | JP5389678B2 (zh) |
| CN (1) | CN101674779B (zh) |
| AU (1) | AU2008231160B2 (zh) |
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| AU2008231160B2 (en) | 2014-01-23 |
| US20080234709A1 (en) | 2008-09-25 |
| US9050124B2 (en) | 2015-06-09 |
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| EP2131758B1 (en) | 2018-01-03 |
| EP2131758A4 (en) | 2012-12-19 |
| EP2131758A1 (en) | 2009-12-16 |
| WO2008118685A1 (en) | 2008-10-02 |
| US20130012970A1 (en) | 2013-01-10 |
| US8236019B2 (en) | 2012-08-07 |
| JP2010522030A (ja) | 2010-07-01 |
| AU2008231160A1 (en) | 2008-10-02 |
| CN101674779A (zh) | 2010-03-17 |
| JP5389678B2 (ja) | 2014-01-15 |
| US20100179577A1 (en) | 2010-07-15 |
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