CN102781352A - 超声外科器械的外部护套和刀片构造 - Google Patents
超声外科器械的外部护套和刀片构造 Download PDFInfo
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Abstract
本发明在多种实施例中提供了一种在含水环境中操作的外科器械。在至少一个实施例中,所述外科器械(100)可包括中空护套(230)、至少部分地置于所述中空护套内并延伸穿过所述外皮内开口(231)的刀片(200)以及可操作地连接到所述刀片的至少一个超声换能器(115)。所述刀片可包括多边形横截面形状并且所述顶端(202)可远离所述外皮的纵向轴线(A-A)而突出。在另一个实施例中,所述外科器械(1100)可包括通过其设置抽吸(240)的刀片(1200)以及可操作地连接到所述刀片的至少一个超声换能器(115)。所述刀片可包括设置在刀片开口(1204)上方的切刃(1205)。另外,所述切刃可远离所述刀片的纵向轴线而突出。
Description
背景技术
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。
多年以来,人们已开发出多种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。关节镜外科手术涉及在关节间隙中进行外科手术。为进行该外科手术,通常在关节中填充加压的生理盐水以便扩张和可视。
上述装置通常由电源、手持件和一次性端部执行器构成。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。
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小孔的组织。
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以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设备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。针的超声移动将组织破裂成片。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还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Wuchinich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,该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。
虽然使用超声动力的外科器械较之于传统机械动力的锯、钻和其他器械具有若干优点,但是由于在骨头/组织界面的摩擦生热导致的骨头和相邻组织中的温度上升仍然会是一个显著的问题。当前的关节镜外科工具包括冲头、往复式剃刀和射频(RF)装置。机械装置(诸如冲头和剃刀)产生最小的组织损伤,但是有时候会留下不可取的参差不齐的切割线。RF装置可产生平滑的切割线,也能消融大体积的软组织;然而它们却往往会造成比机械装置更多的组织损伤。因此,能在不产生过多组织损伤的情况下形成光滑切割表面的同时提供增加的切割精度的装置将是可取的。
以上讨论仅仅意图说明本发明所属领域的现状,而不应视为是对权利要求范围的否定。
发明内容
在多种实施例中,提供了一种外科器械。在至少一个实施例中,该外科器械可包括含有开口的中空护套、至少部分置于中空护套内并延伸通过开口的刀片以及可操作地连接到刀片的至少一个超声换能器。在这些实施例中,中空护套可限定纵向轴线,而刀片可包括顶端以及与顶端相邻的为多边形的横截面形状。此外,在这些实施例中,顶端可远离纵向轴线而突出。
在至少一个实施例中,提供了一种外科器械,该外科器械可包括限定纵向轴线的刀片、抽吸口以及可操作地连接到刀片的至少一个超声换能器。在这些实施例中,刀片可包括远端、内腔、邻近远端的第一开口以及设置在第一开口上方的第一切刃。此外,在这些实施例中,第一开口可与内腔连通。另外,第一切刃可远离纵向轴线而突出。此外,在这些实施例中,刀片能够允许从抽吸口至第一开口地施加抽吸。
在至少一个实施例中,提供了一种外科器械,该外科器械可包括限定纵向轴线的刀片、抽吸口以及可操作地连接到刀片的至少一个超声换能器。在这些实施例中,刀片可包括远端、内腔、第一开口、设置在第一开口上方的第一切刃、第二开口以及设置在第二开口上方的第二切刃。此外,在这些实施例中,第一开口和第二开口可与内腔连通。另外,第一切刃和第二切刃可远离纵向轴线而突出,并且第二切刃可邻近第一切刃。此外,在这些实施例中,刀片能够允许从抽吸口至第一开口地施加抽吸。
附图说明
本申请所述实施例的新颖特征在所附权利要求书中进行了详细描述。然而,对机构和操作方法的实施例而言,皆可以通过参照以下具体实施方式(结合附图)更好地理解。
图1是外科手术控制系统实施例的非限制性实施例的示意图。
图2是使用刀片和中空护套的手持式外科器械的非限制性实施例的部分剖视图。
图3是图2的外科器械远侧部的透视图。
图3A是沿图3中的线3A-3A截取的图2外科器械远侧部的剖视图。
图4是图2外科器械远侧部的可供选择实施例的透视图。
图5是图2外科器械远侧部的另一个可供选择实施例的透视图。
图6是图2外科器械的刀片的远侧部的侧视图。
图6A是沿线6A-6A截取的图6刀片的剖视图;为了清晰起见,省略了剖面线。
图7是使用向其施加了抽吸的刀片的手持式外科器械的非限制性实施例的部分剖视图。
图8是图7外科器械的远侧部的透视图。
图9是图7外科器械的远侧部的前视图。
图10是图7外科器械的刀片的远侧部的侧剖视图;该刀片示为正在切割组织以产生随后通过在近侧方向的抽吸而排出的组织碎片。
图11是图7外科器械的刀片的远侧部的透视图;该刀片示为随超声运动而振动。
图12示出了结合进行椎间盘切除术的图7外科器械的用途。
图13示出了结合进行椎间盘切除术的图7外科器械的进一步用途。
图14是图7外科器械刀片远侧部的可供选择实施例的透视图。
图15是图12刀片的远侧部的前视图。
图16是图7外科器械的刀片远侧部的另一个可供选择实施例的透视图。
图17是图14刀片的远侧部的前视图。
图18是图14刀片的远侧部的侧剖视图;该刀片示为正在切割组织以产生随后通过在近侧方向的抽吸而排出的组织碎片。
具体实施方式
本专利申请的所有者也拥有与本专利同一日期提交的以下美国专利申请,这些专利以引用方式相应地全部并入本文:
题为“ULTRASONICALLY POWERED SURGICAL INSTRUMENTSWITH ROTATING CUTTING IMPLEMENT”(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.________;
题为“METHODS OF USING ULTRASONICALLY POWEREDSURGICAL INSTRUMENTS WITH ROTATABLE CUTTINGIMPLEMENTS”(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._______;
题为“SEAL ARRANGEMENTS FOR ULTRASONICALLY POWEREDSURGICAL 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._______;
题为“ULTRASONIC SURGICAL INSTRUMENTS WITH ROTATABLEBLADE AND HOLLOW SHEATH ARRANGEMENTS”(具有可旋转刀片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.________;
题为“ROTATABLE CUTTING IMPLEMENT ARRANGEMENTS FORULTRASONIC 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._______;
题为“ULTRASONIC SURGICAL INSTRUMENTS WITH PARTIALLYROTATING BLADE AND FIXED PAD ARRANGEMENT”(具有部分旋转刀片和固定垫片构造的超声外科器械)、代理人案卷号为END6693USNP/090346的美国专利申请No._______;
题为“DUAL PURPOSE SURGICAL INSTRUMENT FOR CUTTINGAND 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.________;
题为“ULTRASONIC SURGICAL INSTRUMENTS WITH MOVINGCUTTING IMPLEMENT”(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
题为“ULTRASONIC SURGICAL INSTRUMENT WITH COMB-LIKETISSUE 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.________。
现在将描述某些实施例,以提供对本发明所公开的结构、功能、制造的原理、设备的用途和方法的全面理解。这些实施例的一个或多个例子在附图中示出。本领域普通技术人员将会理解,本文具体描述并在附图中示出的装置和方法是非限制性的实施例,并且这些实施例的范围完全由权利要求书来限定。结合一个实施例进行图解说明或描述的部件可以与其他实施例的部件进行组合。此外,当指出一过程中的步骤顺序时,根据需要,这样的顺序可以重新安排,或者步骤可以同时进行,除非不合逻辑或明确要求所列出的顺序。这样的修改形式和变型形式旨在纳入所附权利要求书的范围内。
在下面的描述中,在若干视图中,相同的附图标记指示相同或对应的部件。另外,在下面的描述中,应当理解,诸如“向前”、“向后”、“前”、“后”、“右”、“左”、“在...上方”、“在...下方”、“顶部”、“底部”、“向上”、“向下”、“向近侧”、“向远侧”等词是方便型用语,不应认为是限制性术语。下面的描述是为描述各种实施例之目的,并非意图限制所附权利要求。
多个实施例涉及能够在外科手术期间施行组织解剖、切割和/或凝固的改良超声外科系统和器械以及因而所采用的切割工具。在一个实施例中,超声外科器械设备能够用于开放性外科手术,但所述设备也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)。超声能量的选择性使用和/或靠近和/或通过切割/凝固工具而施加的抽吸有利于多用途使用。
应当理解,本文使用的术语“近侧”和“远侧”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,包括例如切割/凝固工具,相对于较近的手持件组件而言处于远侧。还应当理解,为方便和清晰起见,本文根据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。
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,而后者可包括超声产生部件。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连接到外科器械组件100的外壳部分102中的超声换能器组件114上。换能器组件114可包括一个或多个能够产生超声振动的超声换能器。另外,喇叭件124可连接到超声换能器组件114以放大和/或集中由换能器组件114产生的超声移动。刀片200可连接到喇叭件124,该刀片至少部分地位于从外壳部分102延伸的外部中空护套230内。在至少一个实施例中,喇叭件124和刀片200可以由同一块材料一体和整体地形成。在另一个实施例中,喇叭件124和刀片200可为附接到一起的单独部件。
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(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(诸如铜线)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。
已知多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 MountFor Ultrasonic Surgical Instruments”(超声外科器械的旋转换能器架)的共同拥有的美国专利申请No.12/503,770中有所公开。其他此类装置在以下全部以引用方式并入本文的一篇或多篇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 anUltrasonic System Under Zero Load Conditions”(在零负载条件下改进超声系统的启动的方法));美国专利No.6,537,291(“Method for Detecting aLoose 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片的方法));美国专利No.6,626,926(“Method for Driving an Ultrasonic System to Improve Acquisitionof Blade Resonance Frequency at Startup”(驱动超声系统以在启动时改进对刀片谐振频率的获取的方法));美国专利No.6,633,234(“Method forDetecting Blade Breakage Using Rate and/or Impedance Information”(利用速率和/或阻抗信息检测刀片破损的方法));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片的存在的方法));美国专利No.6,678,621(“OutputDisplacement 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 UltrasonicHandle”(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 UltrasonicSurgical 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 HandpieceSystem”(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 TransducerTemperature”(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 ImproveAcquisition of Blade Resonance Frequency at Startup”(驱动超声系统以在启动时改进对刀片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 UltrasonicSurgical System”(在超声外科手术系统中警示发生器功能的设备和方法))。
如在图2中可见,超声外科器械100可包括封装超声换能器组件114和喇叭件124的外壳102。换能器组件114可通过支架104固定地支撑在外壳102内。刀片200可从喇叭件124延伸,其穿过中空护套230直到限定在其中的窗口或开口231。如图2所示,刀片200的远侧顶端202可通过位于外科器械100的远侧部250的开口231而看见。外科器械100的刀片顶端202和/或远侧部250可被视为器械100的“端部执行器”。如将在下文中更详细地说明,在与中空护套的纵向轴线A-A平行或共轴的近侧方向“PD”或远侧方向“DD”上相对于组织移动器械时,刀片200可沿与其横向的方向或两者之间的任何方向切割组织。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)和/或通过一种或多种粘接剂连在一起,并且可由例如聚碳酸酯、不锈钢或其他材料制成。
仍参见图2,超声换能器组件114可包括支撑压电超声换能器115的外壳118,而压电超声换能器用于将电能转换成机械能,机械能则引起换能器115末端的纵向振动运动。超声换能器115可包括陶瓷压电元件的叠堆,其运动零点在沿着该叠堆的某一点处。超声换能器115可安装在近端件116和远端件117之间。另外,喇叭件124可在一侧被安装到零点处的远端件117以及在另一侧被安装到刀片200。因此,刀片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随各器械而变化,并为存储在器械的非易失性存储器中因而系统可以使用的值。
可设计外科器械100的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的刀片200的直径减小,纵向前后运动增大。因而,可制定喇叭件124以及刀片200的形状和尺寸以便扩大刀片运动并提供与声学系统其余部分谐振的超声振动,其使靠近刀片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115处20至25微米的运动可通过喇叭件124扩大为约40至100微米的刀片运动。
简略地回顾图1,当电力通过开关构造而施加到超声器械110时,超声发生器12可(例如)使刀片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,可设计刀片200按超声振动速率在约40至100微米的范围内纵向运动。刀片200的该超声振动将在刀片接触组织时产生热量,即通过组织的刀片200的加速将运动刀片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固区域,这将减少或消除小血管的出血,诸如直径小于一毫米的那些血管。刀片200的切割效率以及止血程度将随应用的驱动电力水平、外科医生施加给刀片的切割速率或力度、组织类型的性质和组织的血管分布而变化。
再次参见图2,外科器械100以及继而刀片200可由用户相对于要切割的组织作大幅度移动。如本文所用,术语“大幅度运动”等将不同于可通过超声换能器组件实现的“超声运动”等。相反,术语“大幅度运动”涵盖不仅由超声换能器组件114的运行而产生的平移和旋转运动。
为向超声器械110提供来自超声发生器12的电力(参见图1),可使用柔性线槽或多段连接的保护器110。如在图2中可见,导体151、152被连接到超声换能器组件114并穿过外壳102伸出器械。另外,保护器110可在一端连接到器械外壳102并在另一端连接到换能器组件外壳118。导体151、152可穿过换能器组件外壳中的一个或多个孔。因此,来自超声发生器12的超声信号通过导体151、152被传送到超声换能器115。例如当制造器械100时,保护器110可防止导体151、152在外壳102内被损坏或挤压。
仍参见图2,多个实施例还包括远侧突鼻件160,该突鼻件通过紧固件和/或粘接剂(未示出)可拆卸地连接到外壳102的远端。突鼻件160可由(例如)不锈钢、铝或塑料制成。在多种实施例中,刀片200的远端202延伸通过突鼻件160的中空部分210。中空护套230可同样地延伸通过中空部分210。中空部分210可包括环形槽,在其中近侧密封件212可抵靠着中空护套230的末端并抵靠着刀片200而固定。密封件212可包括(例如)硅树脂O形环、和/或钎焊或压力配合密封件,并用于在突鼻件160、刀片200和中空护套230之间建立基本上的流体密封和/或空气密封。
同样在多种实施例中,中空护套230可与刀片200同轴对齐并通过(例如)焊接、压力配合、螺接和用胶水或其他粘接剂粘附等连接到突鼻件160的中空部分210。如在图2中可见,抽吸口240可被连接到突鼻件160以与中空护套230中的近侧孔232连通。柔性管242可连接到抽吸口240并与连接到通常示为244的真空源的收集容器243连通。因而,中空护套230形成围绕刀片200而延伸的抽吸通道,其始于外部护套230的远侧部250(诸如在开口231处)并从孔232伸出直到抽吸口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,类似于近侧密封件212,远侧密封件213也可被固定在突鼻件160中并可有助于进一步密封其中的中空护套230,使得从开口231通过护套230伸出孔232并通过口240的抽吸通道保持最少的或无上述通道外部的空气进入。作为另外一种选择,突鼻件中可省略抽吸口,并且外科器械可在不向开口231施加抽吸的情况下运行。
外科系统10(参见图1)的多种实施例提供了向刀片200选择性施加超声轴向运动的能力。如果需要,临床医生可在用刀片200切割组织之前或切割组织时激活超声换能器组件114。纵向超声运动的频率范围可为约(例如)30-80kHz。相似地,临床医生可能想要在不激活超声换能器组件114的情况下移动器械100以及继而移动刀片200。因而,可将大幅度运动施加给刀片200而不对其施加纵向超声运动。在其他应用中,临床医生可能想要通过激活超声换能器组件114以及通过相对于要切割的组织大幅度移动刀片200两者而使用器械100。在此类实施例中,刀片200将经历来自换能器组件114的纵向超声运动和来自临床医生移动的大幅度运动。此外,本领域的普通技术人员将容易认识到可结合关节镜以及其他外科应用有效地使用外科系统10的多种实施例。
外科器械100可具有多种远侧部。图3和图3A示出了外科器械的非限制性实施例的远侧部250的例子,其中先前用以描述上文公开的多种实施例的相同标号用来标出相同的部件。图3是外科器械的远侧部250的透视图,图3A是沿图3中的线3A-3A截取的远侧部250的剖视图。在这些实施例中,外科器械包括含有开口231的薄中空护套230、至少部分置于中空护套230内并延伸通过开口231的刀片200以及可操作地连接到刀片200的至少一个超声换能器(未示出,参见图2中的换能器115)。
如在图3和图3A中可见,在多种实施例中,刀片200可包括远侧顶端202,该远侧顶端远离护套的纵向轴线A-A而突出以有利于组织切割。更详细地,远侧顶端202可远离中空护套纵向轴线A-A而突出L1的距离。距离L1可具有足够大小以增加刀片的切割效力。在至少一个实施例中,L1可为至少0.25英寸。在另一个实施例中,L1可小于或等于0.75英寸。在另一个实施例中,L1可在0.25英寸和0.75英寸之间(包括0.25英寸和0.75英寸),换句话讲,1/4≤L1≤3/4″。
另外,中空护套可被构造为暴露刀片200的多个部分以进一步有利于各种情形的组织切割。例如,仍参见图3,在至少一个实施例中,护套的开口231可限定一个平面,该平面与纵向轴线A-A相交并且不横向于该纵向轴线。如本文所用,术语“横向”意指与纵向轴线成直角。换句话讲,开口231与纵向轴线成一角度,从而仅在中空护套230的一侧215暴露刀片。在此类实施例中,刀片的背面215,即与刀片顶端202突出的方向相对的侧面215,可由护套230遮蔽以使得不会在该侧面215上无意地切割组织。另外,如上所述,护套230可较薄,并能够使得其包覆模制在刀片230上。在此类实施例中,刀片200和护套230之间的空隙(参见图3A)可最小化。
作为另外一种选择,现在参见图4,在至少一个实施例中,外科器械的远侧部350的中空护套330可包括开口331,其允许刀片200从中突出,同时暴露刀片200的背面215以增加可用于切割组织的切割表面和/或切刃。在此类实施例中,开口331可限定第一平面P1和与第一平面相交的第二平面P2,并且刀片可延伸通过第一平面P1。第一平面P1可与纵向轴线A-A垂直,并且当第二平面P2与第一平面P1相交时,第二平面P2可与第一平面成一角度。
在另一个可供选择的实施例中,外科器械的远侧部450的中空护套450可包括保护性唇缘433,其可进一步避免刀片200无意地切割组织。更详细地,虽然刀片可延伸通过开口431,但可能仍期望防止在刀片的背面215上切割组织。因此,保护性唇缘433可朝顶端202延伸并远离纵向轴线A-A,从而遮蔽(例如)比图3中所示更大的刀片200的部分。
在多种实施例中,现在参见图6和图6A,刀片200可包括多种结构以增强其切割和/或凝固能力。更详细地,图6是刀片200的远侧部的侧视图,图6A是沿线6A-6A截取的刀片200的剖视图。注意,在图6A中,为了清晰起见,省略了剖面线。在至少一个实施例中,如在图6中可见,刀片200在邻近顶端202处可发生弯曲。简略地回顾图3,可看到刀片200通过开口231而弯曲。刀片200的弯曲形状可使得在顶端202附近沿刀片200形成光滑的切割。更具体地讲,刀片可弯曲设定的量,使得顶端相对于中空轴的轴线A-A成某一角度突出(参见图3)。关注于图6,刀片200可限定第一轴线A′-A′。如在图3A中可见,在中空轴内,第一轴线A′-A′可与中空轴的轴线A-A共线或平行。不管怎样,回顾图6,刀片200还可限定穿过顶端202的第二轴线B-B。第二轴线A-A可与顶端处或顶端附近的刀片曲线相切。第一和第二轴线可限定角度θ,该角度等于或大于60度,但等于或小于90度。换句话讲,60°≤θ≤90°。此类顶端角可为刀片200提供增强的切割功能。
刀片的顶端202和/或横截面的形状可进一步增强刀片200的切割能力。例如,在多种实施例中,现在参见图6A,刀片200可通过使用邻近顶端202的为多边形的平面形状而增加其提供的切割表面数。更具体地讲,在至少一个实施例中,多边形横截面形状可为四边形,并且甚至更具体地讲,为菱形或等边平行四边形。通俗地讲,菱形形状可以被看作金刚石形状。此类形状可允许刀片提供锋利的顶点,诸如在图6A中所见的在侧面203、204、205和206之间限定的顶点207、208、209和210,这些顶点形成刀片的切刃的一部分。顶点(诸如顶点207)的锋利程度可如下限定。在菱形的一边(诸如边203)和菱形的中心线(诸如中心线“CL”)之间限定的角度α可等于或大于10度但等于或小于25度。换句话讲,10°≤α≤25°。通过使用此类锋利边缘,如由菱形形状的顶点所限定,刀片200可使打磨的需要降低。
另外,刀片的横截面形状可使刀片降低穿过含水或其他流体的阻力,以在这样的环境中更好地运行。例如,在至少一个实施例中,横截面菱形形状可在一个方向较长并且在另一个方向较短。更详细地,菱形形状可通常分别沿近侧和远侧方向PD和DD较长。具体地讲,菱形的其中两个顶点207和209还可限定轴线C-C(参见图6A),该轴线与刀片的纵向轴线共面(参见图3A)。因此,当分别沿近侧和远侧方向PD和DD移动刀片时,在流体环境中刀片经历的阻力得以降低。另外,可将刀片制作得较薄,使得刀片200具有0.020英寸至0.040英寸的从顶点208至顶点210的宽度L2。换句话讲,0.020″≤L2≤0.040″。在至少一个实施例中,L2可为0.030英寸。
在多种实施例中,顶端202还可包括逐渐变细至一个点的多边形横截面形状。例如,在至少一个实施例中,参见图6,顶端的形状可为锥形。因此,顶端的尖端和顶端锥形形状的边缘均可有助于增强的切割点和/或切刃。
另外,在至少一个实施例中,刀片200可(例如)沿着其整个长度或至少沿着也驻留在中空护套230内的刀片200的一部分为多边形,参见图3A。通过沿着刀片长度的至少一部分使用均匀横截面,可减少制造成本和资源。
外科器械可使用其他刀片和/或护套构造以在流体环境中实现增强的切割和/或凝固。例如,在多种实施例中,外科器械可利用抽吸以增强从外科目标的切割和被切断组织的移除。更详细地,图7-11示出了外科器械1100的非限制性实施例的另一个例子,其中先前用以描述上文公开的多种实施例的相同标号用来标出相同的部件。图7是向其施加了抽吸的刀片1200的手持式外科器械1100的部分剖视图。外壳102、换能器组件114、喇叭件124和相关部件可类似于上文相对于外科器械100所述的那些。至少一个超声换能器,诸如换能器组件114中的换能器115,可以通过喇叭件124可操作地连接到刀片1200。刀片1200可限定纵向轴线A-A,其也类似于上述的纵向轴线A-A。另外,刀片1200可包括主体1201,该主体在其中限定内腔1220并包括远端1202。邻近远端1202处可为开口1204,该开口与内腔1202连通。此外,可将第一切刃1205设置在开口1204的上方。第一切刃1205也可远离纵向轴线A-A而突出,以进一步增强组织切割,如在下文中更详细地说明。
外科器械1100可进一步包括连接到突鼻件1160或与突鼻件一起形成的抽吸口240。抽吸口240可通过在刀片1200中形成、设置在突鼻件1160内并与口240对齐的抽吸孔1221而与内腔1220连通。柔性管242可连接到抽吸口240并与连接到真空源244的收集容器243连通。因此,刀片1200可形成延伸通过刀片1200的抽吸通道,其始于外科器械1100的远侧部1250,诸如在开口1204处,沿着内腔1220的至少一部分行进,并从抽吸孔1221伸出直到抽吸口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,近侧密封件1212和远侧密封件1213可被固定在围绕口240的突鼻件1160中的环形槽内,并可有助于进一步密封其中的刀片1200,使得从开口1204通过刀片1200伸出孔1221并通过口240的抽吸通道保持最少的或无上述通道外部的空气进入。因此,刀片1200从而能够允许从抽吸口240至开口1204地施加抽吸。
另外,在至少一个实施例中,可使用外部中空护套1230,其可起到安全屏蔽的作用,以在从外科手术部位引入和/或移除外科器械1100时至少覆盖刀片1200的切刃1205和/或开口1204。可回缩的中空护套1230可被活动安装在刀片1200上,并可从基本上覆盖开口1204和/或切刃1205的闭合位置选择性地移动至暴露开口1204的打开位置(参见图8)。这种构造可在靠近重要的神经和其他关键组织插入和移除与刀片1200的过程中覆盖刀片1200上的切刃1205和/或开口1204。为了有利于刀片1200上的中空护套1230的移动,可在中空护套1230的近端上形成拇指控制片1232(图7)以使临床医生能够向其施加滑动致动力。
在多种实施例中,可使用不同的刀片构型以增强从外科目标的组织切割和排出。现在关注于外科器械1250的远侧部,其在图8中可最清楚地看见,刀片的形状可为管状。另外,可看见切刃1205被设置在开口1204上方并远离刀片的纵向轴线A-A而突出。在至少一个这样的实施例中,现在关注于由图9所提供的远侧部1250的前视图,可看见切刃限定了一个弧形。因此,可平滑地切割组织(诸如椎间盘组织)并使其沿着弧形切刃1205成形。
通过关注于图10-11可发现有关刀片1200的进一步细节。图10示出刀片1200的远侧部的侧剖视图,图11示出刀片1200的远侧部的透视图。切刃1205可由与刀片的主体1201整体地形成或以其他方式连接到其上的切割护罩1210限定。如在图10中可见,护罩1210和切刃1205可远离纵向轴线A-A以及远离主体1201而突出。另外,护罩的横截面形状(也在图10中所见)可与主体1201成一角度突出,以将切刃1205更好地呈现给组织T。另外,如在图10中可见,刀片的切刃1205示为正在切割组织“T”以产生组织碎片“TF”,其随后通过沿近侧方向PD的抽吸而拉进穿过开口1204并排出,如上所讨论。可在沿远侧方向DD推进刀片1200时切割组织,使得切刃1205抵靠着组织T而将其自身嵌入或以其他方式刮擦组织的表面。作为另外一种选择,可通过施加到开口1204的抽吸将组织吸入切刃1205内。另外,在存在抽吸的情况下,组织碎片TF可被清除出外科目标区域,从而消除或减少对患者反复插入和移除外科器械的需要。另外,如图11所示,刀片1200随着由一个或多个超声换能器115(参见图7)所产生的超声运动而振动,以进一步增强切刃切断和/或消融组织的能力。
回顾图7,在使用中,临床医生可激活真空源244以切割和排出组织。当遇到易出血的患者时,临床医生可激活超声换能器组件114以向刀片1200发送超声运动以用于凝固目的。例如,由于多种疾病状态,脊柱融合外科手术需要移除椎间盘材料。很多时候,该材料变得坚韧并需要用常规器械施加相当大的力以使椎间盘破碎并移除其碎片。一旦移除了椎间盘材料,就必须刮擦终板以显露新生表面,从而促进板与融合器(cage)的融合。还必须制定板的形状以与所用类型的融合器良好贴合。常规器械通常需要来自外科医生的非常靠近关键结构的高强度力。
当进行(例如)图12和图13所示的椎间盘切除术时,使用上述外科器械1100可特别有利。如在这些附图中可见,可将刀片1200插入椎间盘“D”。刀片1200可用于刮掉小的椎间盘碎片并将其吸出。此类构造将消除反复插入/移除外科工具的需要。该装置也可用于制备椎体终板。通过采用穿过刀片1200的抽吸、提供给刀片1200的超声运动和/或独特的刀片构型,可减小临床医生制备终板时必须施加的输入力的量。相似地,可降低破碎并移除椎间盘材料所需的外部力的量。另外,可减少外科手术过程中的器械交换次数。
外科器械1100可具有各种来自上文所提供的刀片。例如,图14示出了外科器械1100(参见图7)的刀片1300的远侧部的可供选择实施例的透视图,图15示出了刀片1300的远侧部的前视图。在至少一个实施例中,刀片1300可类似于上述的刀片1200,不同的是,其可包括不止一个开口和/或切刃,它们可有利地设置在刀片上。更详细地,刀片可限定纵向轴线A-A并可包括远端1302、内腔(未示出,参见图7中的内腔1220)以及邻近远端1302并与内腔连通的第一开口1304。刀片1300可包括第一切刃1305,其设置在第一开口1304上方并远离纵向轴线A-A突出,类似于上文所述的切刃1204。另外,刀片1300还可包括也与内腔连通的第二开口1309,以及设置在第二开口1309上方并远离纵向轴线A-A突出的第二切刃1306。第一开口1304和第二开口1309均可位于沿刀片1200的同一相对纵向位置处。换句话讲,开口1304、1309两者沿着纵向轴线A-A距远端1302的距离可以相同,然而,开口1304、1309两者沿着刀片主体1301的角位置可以不同。
添加不止一个开口可增加刀片1300可切割组织的位置数。因此,在至少一个实施例中,刀片1300可进一步包括第三开口1307以进一步增加刀片的切割位置数。更详细地,第三开口也可与内腔连通并与其他开口1304、1309设置在相同的纵向位置。第三切刃1307可设置在第三开口1314上方并且也可远离纵向轴线A-A突出。各切刃1305、1306、1307可分别由切割护罩1310、1311、1312限定,这些护罩可类似于上文所述的护罩1210。另外,开口1304、1309、1314、切刃1305、1306、1307和/或护罩1310、1311、1312中的每一者均可关于纵向轴线对称并设置成彼此等距。参见例如图15。
虽然上述实施例中的一些已示出了一个或多个面向远侧的切刃,但是外科器械1100可包括具有一个或多个面向近侧的切刃的刀片。例如,图16示出了外科器械1100(参见图7)的刀片1400的远侧部1400的另一个可供选择实施例的透视图,图17示出了刀片1400的远侧部的前视图,而图18示出了刀片1400的远侧部的侧剖视图,此时刀片1400正在切割组织T以产生组织碎片TF,其随后通过近侧方向的抽吸而被排出,与上文所述的类似。在至少一个实施例中,刀片1400可类似于上文所述的刀片1200,不同的是其可包括不止一个开口和/或切刃,它们可彼此并置。
更详细地,刀片可限定纵向轴线A-A并且可包括远端1402、内腔1420以及邻近远端1402并与内腔1420连通的第一开口1404。刀片1400可包括设置在第一开口1404上方并远离纵向轴线A-A而突出的第一切刃1405,其类似于上文所述的切刃1204。另外,刀片1400也可包括第二开口1409,其邻近第一开口和/或邻近第一切刃1405。第二开口1409也可与内腔1420连通。另外,第二切刃1406可设置在第二开口1409上方并远离纵向轴线A-A而突出。第一开口1404和第二开口1409可位于沿着刀片1400的不同纵向位置处,但两者可位于沿着刀片主体1401的相同角位置处。换句话讲,开口1404、1409可位于刀片1400的相同侧。在至少一个实施例中,切刃1405、1406可由相同的切割护罩1410限定。在此类实施例中,护罩1410可设置在开口1404、1409两者的上方。
参见图18,可在沿着远侧方向DD推进刀片1400时切割组织,使得面向远侧的第一切刃1405抵靠着组织T将其自身嵌入或以其他方式刮擦组织的表面。另外,可在沿近侧方向将刀片1400缩回时切割组织,使得面向近侧的第二切刃1406抵靠着组织T将其自身嵌入或以其他方式刮擦组织的表面。作为另外一种选择,可通过施加到开口1404、1409的抽吸将组织吸入切刃1405、1406的一者或多者内,如上所述。另外,在存在抽吸的情况下,组织碎片TF可被清除出外科目标区域,从而消除或减少对患者反复插入和移除外科器械的需要。另外,刀片1400可随着由一个或多个超声换能器115(参见图7)所产生的超声运动而振动,以进一步增强切刃切断和/或消融组织的能力。
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分以及随后组装。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分或零件。清洗和/或置换某些部分后,该装置可以在重新恢复设施处重新组装以随后使用,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。
优选地,在外科手术前实施本文所述的各种实施例。首先,获取新的或用过的装置,并在必要时对装置进行清洁。然后对器械进行灭菌。在一种灭菌技术中,将器械置于封闭并密封的容器中,例如塑料或TYVEK口袋中。然后将容器和装置置于能够穿透该容器的辐射区,例如γ辐射、x-射线或高能电子。辐射将装置上和容器中的细菌杀死。然后将灭菌后的装置保存在无菌容器中。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。灭菌也能够通过本领域技术人员已知的任何种方式进行,包括β辐射或γ辐射、环氧乙烷和/或蒸汽灭菌。
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灭菌包装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装中,其中可将所述包装运送至灭菌设施。在灭菌设施处,可对超声器械消毒,其中任何耗费部件都可被丢弃和更换,任何可重复使用的部件都可被灭菌和再次使用。其后,超声器械可进行重新组装、测试、置于无菌包装中和/或在置于无菌包装中之后进行灭菌。一旦经过灭菌,该重新处理的超声外科器械就可再次使用。
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。
以引证方式全部或部分地并入本申请的任何专利、公布、或其他公开材料仅在所并入的材料不与本发明所述的现有定义、陈述、或其他公开材料相冲突的范围内并入本申请。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 (20)
1.一种外科器械,包括:
具有开口的中空护套,其中所述中空护套限定纵向轴线;
至少部分置于所述中空护套内并延伸通过所述开口的刀片,其中所述刀片包括顶端以及邻近所述顶端的为多边形的横截面形状,并且其中所述顶端远离所述纵向轴线而突出;以及
可操作地连接到所述刀片的至少一个超声换能器。
2.根据权利要求1所述的外科器械,其中所述开口限定一个平面,所述平面与所述纵向轴线相交并且不横向于所述纵向轴线。
3.根据权利要求1所述的外科器械,其中所述开口限定第一平面和与所述第一平面相交的第二平面,其中所述刀片延伸通过所述第一平面。
4.根据权利要求1所述的外科器械,其中所述中空护套还包括朝所述顶端延伸的保护性唇缘。
5.根据权利要求1所述的外科器械,其中所述刀片还包括顶端,所述顶端远离所述纵向轴线至少0.25英寸,但远离所述纵向轴线不超过0.75英寸。
6.根据权利要求1所述的外科器械,其中所述刀片靠近所述顶端发生弯曲,其中所述刀片限定所述中空护套内的第一轴线和穿过所述顶端的第二轴线,其中所述第一轴线和第二轴线限定一个角度,并且其中所述角度等于或大于60度,但等于或小于90度。
7.根据权利要求1所述的外科器械,其中所述顶端包括锥形形状。
8.根据权利要求1所述的外科器械,其中所述多边形是四边形。
9.根据权利要求8所述的外科器械,其中所述四边形是菱形。
10.根据权利要求9所述的外科器械,其中所述菱形在所述菱形的一边和所述菱形的中心线之间限定一个角度,其中所述角度等于或大于10度,但等于或小于25度。
11.根据权利要求9所述的外科器械,其中所述菱形包括四个顶点,其中所述顶点中的两个顶点限定与所述刀片的纵向轴线共面的轴线。
12.根据权利要求1所述的外科器械,还包括:
与所述中空护套连通的抽吸口,其中所述中空护套能够允许从所述抽吸口至所述开口地施加抽吸。
13.一种外科器械,包括:
限定纵向轴线的刀片,其中所述刀片包括远端、内腔、邻近所述远端并与所述内腔连通的第一开口、以及设置在所述第一开口上方并远离所述纵向轴线突出的第一切刃;
与所述内腔连通的抽吸口,其中所述刀片能够允许从所述抽吸口至所述第一开口地施加抽吸;以及
可操作地连接到所述刀片的至少一个超声换能器。
14.根据权利要求13所述的外科器械,其中所述第一切刃限定弧形。
15.根据权利要求13所述的外科器械,其中所述第一开口位于所述刀片上的第一纵向位置处,并且其中所述刀片还包括:
位于所述第一纵向位置处的第二开口,所述第二开口与所述内腔连通;以及
设置在所述第二开口上方并远离所述纵向轴线突出的第二切刃。
16.根据权利要求15所述的外科器械,其中所述刀片还包括:
位于所述第一纵向位置处的第三开口,所述第三开口与所述内腔连通;以及
设置在所述第三开口上方并远离所述纵向轴线突出的第三切刃。
17.根据权利要求13所述的外科器械,其中所述刀片还包括:
邻近所述第一开口的第二开口,所述第二开口与所述内腔连通;以及
设置在所述第二开口上方并远离所述纵向轴线突出的第二切刃。
18.根据权利要求17所述的外科器械,其中所述第一切刃和第二切刃由切割护罩限定。
19.一种外科器械,包括:
限定纵向轴线的刀片,其中所述刀片包括远端、内腔、与所述内腔连通的第一开口、设置在所述第一开口上方并远离所述纵向轴线突出的第一切刃、与所述内腔连通的第二开口以及设置在所述第二开口上方并远离所述纵向轴线突出的第二切刃,其中所述第二切刃在所述第一切刃近侧;
与所述内腔连通的抽吸口,其中所述刀片能够允许从所述抽吸口至所述第一开口地施加抽吸;以及
可操作地连接到所述刀片的至少一个超声换能器。
20.根据权利要求19所述的外科器械,其中所述刀片还包括与所述内腔连通的第三开口以及设置在所述第三开口上方的第三切刃。
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JP2013519441A (ja) | 2013-05-30 |
CN102781352B (zh) | 2016-06-15 |
BR112012020166A2 (pt) | 2020-08-25 |
BR112012020166B1 (pt) | 2021-05-04 |
US20110196403A1 (en) | 2011-08-11 |
WO2011100338A3 (en) | 2011-12-08 |
CA2789478A1 (en) | 2011-08-18 |
US20140066962A1 (en) | 2014-03-06 |
EP3597127A1 (en) | 2020-01-22 |
EP2533707B1 (en) | 2019-09-18 |
AU2011215926A1 (en) | 2012-08-23 |
JP5875991B2 (ja) | 2016-03-02 |
US9510850B2 (en) | 2016-12-06 |
WO2011100338A2 (en) | 2011-08-18 |
EP2533707A2 (en) | 2012-12-19 |
US8579928B2 (en) | 2013-11-12 |
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