CN1120805A - 有创去除组织的方法和装置 - Google Patents
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Abstract
一种用于最低限度创伤的组织去除方法和装置,设想出一个系统,它包括一个具有可在经皮引入的套管(15)内往复运动的由一个电机驱动的切割切片(16)的组织切割用具(10)。根据本发明的一种方法,切割刀片的往复运动频率被调到待切除组织的特征频率上。该系统的另一方面具有系统的抽吸(22)和冲洗(23)回路的反馈控制,这些回路与用户可设置的输入相连接,以使得外科医生可以控制该系统以便将组织“拨”入到切割开口内,可控阀(32)和压力传感器(33)允许使用者设置抽吸真空和冲洗压力并将它们保持在优选值上。
Description
本发明涉及用于切除和去除多种组织的外科手术方法及装置。本发明用于包括下列部位在内的高精细手术,如神经、脊柱、矫形外科、眼科、牙科、妇科、胃肠、泌尿、耳鼻喉以及心血管,还有体内其它一些在组织去除中需要极为小心的部位。虽然本发明可用于多种手术,但下面公开的内容主要涉及在矫形外科或脊柱外科手术领域中所采用的最低限度侵害技术。
在脊柱外科手术领域,一个经常要被诊断和治疗的问题就是椎间盘变性或椎间盘突出。在椎间盘中发生结构上的改变,这可能是由于超负荷条件或随年龄的正常变性的缘故。椎间盘问题可能会简单得象一大部分人都体验过的慢性腰痛,或者严重得象椎间盘组织最终不起作用的状况。过去,治疗椎间盘疾病需要复杂而且高度侵害的外科手术。这些手术常常需要在损伤的椎间盘相邻的两个脊椎之间进行某种程度的融合。
近十年来,已经开发出了经皮椎间盘切除术。在授予Onik的美国再颁专利第33,258号以及在1992年刊登在“矫形外科进展杂志”(Journal of Advance in Orthopadic Surgery)上的题为自动经皮腰椎间盘切除术的文章中描述了这样一个系统。在Onik的装置中,待去除组织通过被抽吸进一个外部切割套筒的中心孔内而被拉出来。一个气动内切割套筒象环状刀一样进行操作以切除椎间盘组织,让椎间盘组织悬浮在盐冲洗液中,这也有助于通过内切割套筒切除的推间盘组织的抽吸。
虽然有关用在椎间盘经皮切除术中的这种或其它类似装置的经验是有益的,但是在用于最低限度侵害的组织去除的方法和装置方面还存在改进的余地。采用这些装置的手术比以前的手术方法具有更小的创伤,而且还需要降低在经皮椎间盘切除术以及类似手术中进行组织去除所需的时间。既使是已有技术中的系统也只能在5分钟内去除约0.7克的组织,更快的组织去除意思是说需要更快的手术过程,且还要降低侵害及创伤的危险。此外,正如涉及体内组织切除的任何手术方法一样,本发明的用于组织切除的系统也存在着将与要切除的不需要的组织不同的需要的组织切除的危险。最后,虽然所有的外科手术方法均涉及对周围组织的某些伤害,但正如本发明所要做的,明显需要更进一步的减小与经皮椎间盘切除术有关的创伤的量。
目前,已有技术的组织去除系统一般包括采用自动的气动环状刀或旋转型刀。这些系统存在的一个问题是:组织通常是被撕开的而不是被干净利落地切割。采用旋转式刀,使组织具有“卷绕”或缠绕在刀或驱动轴周围的可能,进而塞满刀具并使刀失效。这些系统还包括重力输注盐水装置,以便对刀具端部提供冲洗液。通过改变输液源的高度来手动控制冲洗液的流动。在缺少可控制的输液源情况下,为了使一个已知手术获得足够的液体,这些已有系统就需要必要的冲洗液源。而且,这些已有系统还要通过蠕动泵或隔膜泵的方式提供一个抽吸真空。这些已有的真空系统通常不能充分地将组织吸进切割孔中并且当过多的组织被吸入到切割孔中时容易出现堵塞。已有技术装置在冲洗和抽吸方面的低效率常常限制组织去除能力,使得已有技术的装置常常无法去除足够多的组织以减轻患者的(例如)椎间盘突出及有关病痛。
已有系统的这些特性导致了在去除组织以及组织去除速度的能力方面的固有的局限性。本发明指出已有技术装置的这些和其它问题以极大地推进最低限度侵害的经皮组织去除领域的发展。
虽然本发明的焦点在于脊柱或矫形外科应用上,但在其它敏感或精细部位组织去除中可以采用类似的组织去除方法和装置。一个实例就是用于神经外科手术,并且具体地用于去除肿瘤、血块、损害、动脉瘤或膜。已经发现已有技术装置通常在神经外科应用中是低效率的。本发明的更广泛应用的实例是用在去除前列腺的泌尿领域、去除卵巢及损伤的妇科手术,去除胆囊结石或肾/胆结石的胃肠外科手术、去除斑块的心血管外科手术,以及活疗白内障的眼科手术中。
图1是根据本发明的最低限度侵害的组织去除系统的一个最佳实施例的一个示意图。
图2是根据本发明而采用的图1所示切割装置的部分剖示的侧视图。
图3是图2所示切割装置头部的一个放大的部分剖面图。
图4是用于图1所示系统的切割器的切割头部的一个变换实施例的一个放大的侧视图。
图5是与图1所示系统结合使用的切割用具的切割器的另一个变换实施例的一个侧视图。
图6是用于图1所示系统的一个实施例中的电路图。
图7是与图1所示系统一起使用的液体系统的一个变换实施例的示意图,该变换实施例为提供给切割器的冲洗液提供了压力反馈控制。
本发明试图提供一种用于最低限度侵害地经皮组织去除的采用手持切割用具的系统。切割用具包括一个手柄和一个支承在手柄上且大小适于经皮引入体内的细长的套管(或者可以在开放式外科手术中使用相同的切割用具)。套管在其远端限定了一个切割开口和一个由近端至切割开口贯穿其中的抽吸通道。一把切割刀片可滑动地安装在靠近远端的套管内,用于横穿切割开口,并且该刀片往复穿过切割开口,以便切除伸入到开口内的组织。采用一个抽吸回路将被切除的组织去除,该回路包括一个废物容器和产生真空的真空发生装置,以便将被切除组织吸入到废物容器内。
该系统还具有一个冲洗回路,该回路包括一个冲洗液源和用来使加压的冲洗液由液源流向套管远端的装置。设有一个主控装置,用于根据操作人员预置的抽吸真空度及冲洗压力的数值控制真空发生装置和加压装置。控制器包括用于根据预置的数值产生抽吸控制信号和压力控制信号的电路系统。设置相应于抽吸控制信号的装置,以便控制真空发生装置产生并保持一种与预置的抽吸真空度数值相等的真空。同样,还设有压力控制信号响应装置,以控制加压装置加压并将冲洗液压力保持在预置的压力值上。
根据本发明的系统,用于抽吸回路的真空发生装置和用于冲洗回路的加压装置都具有与高压气源相连的可控阀。每个阀可控地降低入口处气体的高压,以便在各自的出口处排放相对降低了压力的气体。在抽吸回路中的阀出口与一个真空发生器相连,该真空发生器根据其从可控阀接收到的气体的压力产生一个真空。在冲洗回路中,冲洗液装在一个被压力套筒围绕的弹性容器内。压力套筒从其对应的可控阀接收降低了压力的气体,以便使得套筒中的压力压迫弹性容器及包含在其内的液体。
在一个具体实施例中,在组织切割用具内设有用来感应冲洗回路中的液体压力并将该感应到的液体压力反馈给控制器的装置。控制器将感应到的液体压力与预先设定的冲洗压力值相比较以确定是要增加还是减小冲洗回路中的液体压力以满足预置的数值。
在本发明的另一个方面,主控器为外科医生或操作人员提供了控制抽吸电路系统以有助于将组织“戏弄”到切割开口内的装置。尤其是,本发明试图提供操作人员控制装置,用于可变地控制真空发生装置以产生不超过预置值的可变真空。在采用该系统的方法中,操作人员可以利用增加或减小通过抽吸回路的真空而有选择地将组织吸入到切割开口中。业已发现,真空处于全开或全关状态的已有技术装置将不是太多就是太少的组织吸入到切割开口中。由于本发明的这一特性,外科医生可以交替地控制切割部位的抽吸速率及抽吸状况,以便将最适量的组织吸入到切割开口中,进而提高组织去除过程的效率和速度。
本发明还试图提供一种新颖的采用切割工具从身体中去除目标组织的方法,该工具具有一个往复运动电机驱动的,横穿经皮引入的套管中的一个切割开口的切割刀片。在该方法中,外科医生首先确定对如何切除组织产生影响的目标组织及周围组织的某些特性。这些组织特性包括两者的弹性及强度。这些组织特性与目标组织和周围组织的特性频率相互关连。根据该方法,控制切割用具的速度以使切割刀片以目标组织的特性频率往复横穿切割开口。业已发现,以该组织的特定的特性频率进行的往复运动增加了组织去除速度。或许最重要的是,该谐振的组织切割基本上防止了切割周围组织。本发明的方法还可包括控制抽吸/真空,以便以一个最佳速率将组织吸入到切割用具中。
在本发明的进一步特征中,设置了用于经皮组织去除的手术锉。锉刀构成了上述类型的电机驱动切割用具的一部分。为锉刀提供往复运动的驱动轴在其间限定了一个冲洗通道。锉刀包括多个齿并在与冲洗通道相通的齿之间限定了多个开孔。这些开孔允许加压冲洗液通过其中以便从齿之间排出被切除的组织。在一个具体实施例中,手术锉的外套管包括一个圆头,切割开口伸入到该圆头中,以便使一部分锉刀暴露到套管远端以外。
本发明还提供了一个用于经皮或开放式组织去除的组织分碎器。该组织分碎器也具有类似的手柄和驱动电机。由于这一特征,套管在其远端具有组织引入开口和一个朝向引入开口的在远端上的端面。一个与往复电机驱动轴相连的组织压紧装置具有一个与套管的端面相反设置的压紧表面。当压紧装置被电机往复驱动时,吸入到引入开口内的组织被置于端面和压紧表面之间。
为了增强对本发明原理的理解,现在将对附图中所示实施例的标号并用特定语言对其进行描述。然而应该理解,不打算因此对本发明的范畴做出限制,对于所示装置的变化及进一步改进,以及象图中所示的本发明原理的进一步应用,对于本发明所涉及领域的普通技术人员来说,都将被认为是正常的。
按照本发明的组织去除系统的一个优选实施例,如图1所示,提供了一个组织切割用具10,它包括一个与手柄11相连的一次性切割部件12。该一次性切割器12具有一个外套管15和一个适于在组织去除部位被引入的切割端16。切割器12具有一个用于连接手柄11的连接底部18,和一个用于连接套管15的一体的套管支承体19。连接底部18包括一个从其中延伸出的冲洗口22,而套管支座19具有一个抽吸口23。如这里将要更详细描述的,这两个口被用来在一次性切割器12的切割端16提供冲洗液及抽吸真空。或者,可以通过一个设置在套管15附近并限定了一个外部冲洗通道的独立的引入套管来提供冲洗。
该系统还具有一个废物收集器25,它通过一条抽吸入口管26从切割器接收被切除的组织。入口管26与一次性切割器12的抽吸口22相连。采用一条真空管道29将真空发生器28与废物收集器25相连以便在收集器25内产生真空并沿着抽吸入口管26,按照箭头26a的方向实施抽吸。真空发生器28通过一条压力管道33与可控阀32相连。与真空发生器28结合在一起的可控阀32为连续调节并线性控制实际施加在废物收集器25且最终施加在一次性切割器12的切割端16处的真空值提供了属于本发明范畴内的一种手段。在一个具体实施例中,真空值可以从0至25时汞柱变化。已有装置只是利用了开-关型真空发生器以便使当发生器打开时,向切割器提供抽吸,而当其关闭时,无法进行进一步抽吸。而且,已有装置利用的是在获得设置最大真空值之前产生固有滞后并且在切割部位产生高真空值方面通常不太有效的蠕动泵或膜泵。本发明在驱动时提供了几乎是即时的为操作者预置值的真空,这是由于存在可控阀的缘故。这种阀的一个例子就是由Proportionaire Inc.销售的no.BB1型。
该系统还包括一个通过一条液体出口管道36与节流阀37相连的冲洗液袋35。节流阀37的出口通过液体入口管道38与一次性切割器12的冲洗口22相连。冲洗液袋35中一般包含一种均衡的消毒盐溶液(BSS),将这种液体送入一次性切割器12并送达切割器的切割端16。可以控制节流阀37以改变从液体袋流入到切割器12的冲洗口22的液体流量。该冲洗系统当在必要时用一种吹入气代替BSS以使操作部位膨胀并保持时,可以同样工作很好。
冲洗液袋35被一个压力套筒40所包围。套筒40与可控阀42相连,该阀为液体袋周围的套筒40提供压力。由可控阀42增加到套筒40内的压力使得施加在液体袋35上的压力增加,并接着增加流向一次性切割器12的冲洗液的压力和流速。类似于美国第4,735,613号专利中所示的压力输注装置的一种系统可以与可控压力阀(如阀42)结合起来使用。优选地,阀42的作用是保持由操作者预置的压力值。
通过从压力调节器44延伸出来的压力出口管45向可控阀32和42提供加压空气,或压缩的惰性气体。可以通过入口管46向压力调节器44提供室内空气。由于在一般的手术场所可得到以70-120psi.提供的室内空气,根据本发明的一个具体实施例,压力调节器44将由出口管45提供的压力保持在约70psi.上并以此压力提供给两个阀32和42。
该系统还包括一个电控装置50,它接收信号并将信号提供给各种不同部件以控制或监视它们的操作。控制器50还包括一个带有多个开关和显示器的控制台51。控制装置50还通过一条电机驱动控割线53向手柄11提供控制信号。优选实施例中的手柄11基本上类似于授予本申请共同发明人之一的第4,911,161号美国专利中所示装置。不象已有装置的气动操作,该手柄采用一种磁驱动传感器,或声控线圈来向一次性切割器12的切割器具提供往复运动。手柄和电机的结构和使用在收编于此作为参考的说明书第5列第4-6行和第6列第2行中作了部分描述。为了本公开的目的,可以指出的是,驱动控制线53上的信号向声控线圈电机提供不同的电压和电流以控制其振荡的幅度和速率。
控制装置50还包括通过线54的节流阀控制以确定阀37何时工作并工作多久以限定流入切割用具10的入口线38的液体线流量。一条抽吸阀控制线55从控制装置50延伸到给真空发生器28提供压力的可控阀32。通过线55传到可控阀32的信号被用来控制施加到废物收容器25和抽吸系统的残余物的真空量。一条压力调节控制线57将压力调节器44与电控装置50的控制系统联为一体。这一特征使得压力值可被预置并自动保持。
一条冲洗阀控制线56从控制装置50延伸到第二可控阀42。通过线56传输的信号以压力套筒40的方式控制施加到冲洗液袋35的压力的量,随后压力套筒还控制冲洗液流入组织去除部位处的切割器的压力和流量。
控制器50还从系统的各个部件接收电信号。例如,一个与抽吸可控阀32相关的压力传感器65沿着线66将信号送到控制器。同样,与冲洗可控阀42相关的压力传感器67沿着线68将信号送至控制器。这两种信号均代表通过两个阀提供给其相应部件(分别为废物收集器25和压力套筒40)的压力。因此,传感器为控制器提供了即时反馈,控制器再将信号提供给压力调节器44,抽吸可控阀32、冲洗可控阀42和节流阀37。例如,如果冲洗压力传感器67感应到的压力低于一个期望值的话,则线68上的一个反馈信号就直接传给控制器50以便将调整信号送回到线56上的可控阀42。类似的反馈还施加在可控阀32上。在该具体实施例中,压力传感器65间接地感应所施加的真空,因为真空发生器28产生一个与由可控阀32施加其上的空气压力间接地成比例的真空。
使用者可以利用脚踏板60和控制板51上的旋钮通过向控制器输入的方式预置系统的操作参数。可以踩下脚踏板60来依次起动多个开关。在该次序中的第一个开关是冲洗控制开关61,第二个是抽吸控制开关62,最后一个是切割控制开关63。当踩下脚踏板时,它首先接触并闭合冲洗控制开关61的电路。进一步踩下脚踏板60会造成抽吸/吸入控制开关62的闭合,从而立即产生真空并以线性速率增加。最后,当脚踩开关完全被踩下,用于切割控制的最后一个开关63被闭合。以此方式,这些在一次性切割器12处的动作次序是预先确定的。首先提供冲洗液,随后是切割部位处的吸入/抽吸。一旦完成这两个先行操作,进一步踩下脚踏板时则会开始切割步骤。抽吸作用继续由脚踏板可变化地控制。
通过控制板51上的控制旋钮70和71可以实现对系统的进一步控制。一个控制旋钮70控制冲洗压力,而第二个旋钮71控制切割器具10的速度,两者都是通过控制驱动电机的速度和频率来实现的。可以设想,这两个旋钮70和71的每一个都操纵一个改变施加在线56和53上的电压的相应的变阻器。或者,控制器50可以是一种电子控制器,在这种情况下,旋钮70和71可以向控制器提供一个信号,以产生一组用于冲洗液的压力和用于切割器的操作速度。传感器65和67的信号可以与由旋钮70和71产生的设置点相比较。电子控制器50中的其它电路或软件则向可控阀32和42以及节流阀37提供适当的信号以调节它们的操作并保持操作者的预置值。在一个具体实施例中,线54上至节流阀37的信号是一个由操作者控制的脚踏板产生的开/关信号。
控制板51包括操作指示灯72,每一个代表一次性切割器的一种功能。当踩下脚踏板60时,每一个代表冲洗、抽吸和切割的相应的灯被点亮。控制板51还包括一个模拟显示器73,以显示适当的设置压力和速度。例如,显示器73具有用来表示施加在冲洗液上的正向压力的一种显示器,一个表示切割操作速度的显示器以及表示通过系统的抽吸电路施加的真空量的第三个显示器。冲洗压力和抽吸真空显示器接收来自各自的传感器67和65的信号,而在一个具体实施例中的切割速度显示器直接与旋钮71相连。或者,可以在手柄上安装一个速度传感器以便直接确定电机和切割器的速度。
参照图2表示出了一次性切割器12的详细结构。如前所述。按照第4,911,161号美国专利中所述切割装置,一次性切割器12适于与手柄11相连接。为使一次性切割器12与手柄11成为一体,设置了一个驱动连接体75,它包括一个连接夹具76,这类似于收编在此作为参考的′161号专利中第6列第32-38行所描述的套柄。连接夹具76与冲洗口22一起被固定在一个口连接体77上。口22通过一次性切割器12的连接座18中的槽20延伸。应当理解,连接夹具76与手柄11的声控线圈电机相接,以产生振荡的线性运动。由于冲洗口22与振荡连接夹具76相连,它还将在连接座18内前后移动。槽20容纳了口22的这种往复运动。或者,口22可将液体送到底座18中的一个独立的封闭腔中,而使驱动部件由腔室端部的垫圈支撑。在该变换实施例中,由于口22将保持与底座18固定,槽20可以取消。
驱动连接体还包括一个驱动导管78,它与口连接体77相连以便也象声控线圈电机一样振荡。(注意:当通过一个外接套管提供冲洗液时,导管78可以由一个实芯驱动杆代替)。驱动导管在远端通过套管15延伸并在一端由安装在套管支撑体19内的垫圈79封闭。驱动导管78通过外套管15的整个长度延伸,而其自由端80设在切割器12的切割端16。驱动导管78的内通道78a则在该端80处是敞开的,以使冲洗液直接从冲洗口22一直流向装置的切割端。驱动导管78的冲洗液流出端80由切割刀片85支撑,该刀片85在切割端16处的外套管15内滑动。
一次性切割器12还具有套管支撑体19,其内装有外套管15。套管支撑体19作为一次性切割器组件12的一部分与连接器座18相接。套管支撑体19限定了一个与沿着外套管15的整个长度延伸的抽吸通道82相连通的抽吸腔81。通道82、腔81和吸入口23构成了施加在用具10的切割端16的吸入抽吸或真空的真空回路的一部分。
一个冲洗口87形成在外套管15的顶端以向切割部位注入已通过口22、口连接体77和驱动导管78的冲洗液。一次性切割器12还包括一个固定在驱动导管78端部的切割刀片85。该刀片85具有的外径几乎等于抽吸通道82的内径,由此在驱动导管78的端部产生某种程度的密封效果以使得施加在套管15侧面的切割开口89上的抽吸真空尽可能地接近期望的真空值。切割刀片85具有一个面向后的切割刀刃86(即面向手柄),刀片85的每一次往复,切割刀刃86就切割组织。如图3更详细示出的,在优选实施例中的切割刀片85具有一个切割运动距离90,该距离90稍大于切割开口89的宽度以使得切割下来的全部组织均能被取出。或者,如果,如,抽吸是通过驱动导管78来完成的,则刀片可被设计成在向前的冲程时切割。
再参照图3,说明一次性切割器12的操作情况。如前所述,冲洗液由口87通过驱动导管78并存在于外套管15端部。当踩下脚踏板60(图1)时,首先接通冲洗控制开关61,则操作的第一步是向切割部位引入冲洗液。在本发明的一个很重要的方面,电控器50允许操作者利用控制旋钮70改变冲洗压力。控制器50接收沿着由可控阀42的线68传来的来自压力传感器67的信号,然后在来自传感器的反馈基础上调整通过可控阀传向压力套筒40的空气压力。以此方式,施加到冲洗液袋35上的压力,以接着通过通道82的冲洗液的压力和流速得以调整并保持在预置的压力上。操作者可以根据某种特殊应用的需要,通过调节控制旋钮70来改变该冲洗液的流量。冲洗液压力/流速过大会在切割部位发生旋涡而使得组织T不能全部进入到切割开口89内。冲洗液压力/流速太小也可能导致类似的结果。没有冲洗压力控制的已有装置由于旋涡和湍流的缘故还会造成组织损伤。由于已有技术的装置无法进行可变控制,因此需要有一个大的冲洗液容器以便在整个过程中提供充足的冲洗液。
当进一步踩下脚踏板60时,抽吸控制开关62闭合,使得真空发生器28在抽吸通道82中产生抽吸真空。该真空具有将冲洗液和组织T均吸入到切割开口89中的趋势。尽管冲洗压力一般可恒定地保持在由控制旋钮70设置的压力值上,但是按照本发明,可以预料抽吸或真空值是可以改变的。具体地,如前所述,当脚踏板60将开关62闭合时,抽吸系统被启动。抽吸控制开关62还包括一个可变电阻开关部件62a,该部件根据脚踏板60被踩下的量,向抽吸可控阀32施加一个可变电压。以此方式,手术医生只需改变脚踏板60上的压力就可控制由抽吸通道82施加的抽吸量。
由本发明的这一特征所获得的一个特别的益处就是将组织“拨”入到切割开口89内的能力。在已有系统中,真空或开或关,且一般是设在一个固定的真空值上,因此,这些系统易于产生过量的液体流动并在切割开口处产生旋涡,这不仅降低了切割过程的效率,而且还增加了损伤周围组织的可能性。许多已有装置效率低,因为它们趋向于将组织推离切割器,这就迫使外科医生去“捕捉”被切下的组织。本发明通过提高组织进入到切割开口89中的“可追随性”而解决了这一问题。在本发明实施例的实验中已经发现由本发明装置切割的组织在切割开口的区域自身反折,进而不断地将组织抽入到开口内。
通过控制器50,可控阀32和42以及可变开关62,就可以在注入到切割部位的冲洗液以及通过将组织抽入切割开口内并抽吸组织的切割片段而施加的真空之间保持一种有效的平衡。有了脚踏板60和可变开口62a,当切割刀片85在外套管15的抽吸通道82内往复运动时操作者可以根据需要不断地改变真空值以便将大比例的组织T的片段抽入到切割开口中。显示器73使操作者有机会调整和预置冲洗压力和抽吸真空并在手术过程中将这些值保持在优选水平上。
一旦完成了冲洗和抽吸/吸入,进一步踩下脚踏板60使切割控制开关63闭合从而起动切割器10中的声控线圈电机。(可以设想用一种独立的踏板来控制电机和切割器速度)。当操作者为了冲洗控制而改变可变开关62a上的压力时,切割控制开关63被按下并运行。控制旋钮71改变声控线圈电机的频率,进而控制往复运动的切割刀片85。一种适合于声控线圈电机的控制电路可以是如在收编在此作为参考的′161号专利的图3所示的以及在说明书第6列第54-59行中所述的那样。实质上,声控线圈使切割刀片85振荡以使切割刀片前后通过切割开口89。在一个具体实例中,声控线圈电机可以在1和500Hz之间驱动切割刀片85。声控线圈振荡的幅度直接转化为切割器的移动或行程90。优选的行程应稍宽于切割开口89的最大宽度,使刀片离开开口朝向远端,以便允许通过抽吸通道82中的真空将组织抽入到开口中,并移动得足够远,以便穿过开口朝向近端(手柄端),以便在切割开口89的边缘处整齐地切削组织。
本发明方法的一个重要特征是通过由切割速度控制旋钮71和控制器50控制的切割刀片的可变速度来实现的。已发现人体组织具有选择性切割特性,以便可以以一个特定频率最佳地切割人体组织。该频率将根据被切割组织的类型-即膜、皮肤、肌肉、静脉或动脉,器官等而改变。本发明的一个至今为止已有技术装置没有满足的目标就是提供一种平滑、整齐、无撕裂的组织T的切割。此外,几个已有技术装置中还未满足的另一个目的就是能够只切割需要被切割的组织而不会造成意外地切割邻近好组织的任何危险。已经发现不同组织的选择性切割特性是实现并达到这些目的中的每一个的一个重要特征。可以相信,组织的选择性切割特性基于组织的弹性、纤维含量及软/硬度。所有这些特性产生了一个特定的“共振”频率,在该频率下,组织以最佳地切削或切割动作被切割。这些不同组织特定的切割频率可以通过用多种切割刀片进行测试获得。还发现该频率在某种程度上还受刀片85和切割开口89的几何形状的影响。切割开口89的几何形状确定了将要抽入到开口内的组织的“咬合尺寸”。对于粗糙的纤维组织来说,需要更大的切割面积,以使切割开口89能够略大于纤维组织含量少的组织的切割开口。
人体组织的“共振”频率特性可以通过试图实时改变切割刀片85的速度的本发明而很容易实现。当要切割例如,椎间盘组织时,可以通过设置旋钮71以使切割刀片以适合于该组织类型的速度振荡。以此方式,大大减少了对周围组织损伤的危险。行程长度90和切割开口89的尺寸的适当组合进一步增加了一次性切割器12对咬合尺寸的组织片段进行平滑、整齐、无撕裂、直线切割的能力。
如前面已经讨论过的,遁过开关70和可变开关62A获得了冲洗压力和抽吸真空之间的统一。可以通过由前述脚踏开关驱动的节流阀37提供进一步的控制。操作者可以打开或关闭节流阀来按需要起动或终止真空以便将组织T拨入到切割开口89中。在切割部位处的优选的液压值是很重要的,它有助于拨开组织T。通过图7所示的一个压力反馈系统可以获得其它优点。在该系统中,压力感应管道120接入与液体袋35相连的液体出口管道36中。液压沿着感应管道120传送到压力缓冲器121,其作用是将下游部件与液体绝缘。一个传感器入口122为压力传感器123提供了一个压力信号,所述传感器123优选地安装在控制板51内。传感器123产生一个送到调节电路125的电信号。通过确定操作者预置冲洗压力值的冲洗控制旋钮70和开/关开关126为电路125提供进一步输入。电路125综合这些电信号以产生传向电磁节流阀130的控制信号。
在操作中,压力传感器123产生一个表示将被提供给手柄10的液压信号。当该压力信号通过控制旋钮70设定的预置值改变时,电路125改变电磁节流阀130的状态,以使更多或更少的液体流到手柄。优选地,节流阀130上游液压大于使用者预置值。如果手柄处压力高于期望的预置值的话,则该更高的压力则可由节流阀130准确地降低。虽然在该具体实施例中公开了液压管道120,但可以设想在切割顶端处设置独立的传感器,将信号直接送到传感器123或电路125。
虽然本发明的流体学及控制系统的一个基本应用是用在切割刀片85上,但可以设想采用其它类型的切割头。例如,如图4所示,表示一个锉型切割刀片106在外套管15中往复运动。锉型切割刀片106包括锯齿107,它们只适合于配备椎间盘的终板。在多种椎间盘手术中。有必要降低脊椎终板至“出血骨”以便于脊椎间的融合。锉型切割刀片106与冲洗导管108一体或固定在其上,而导管108与驱动机构相连。出口109是在锯齿107之间形成的并与导管108相连通。通过该出口109的液体不仅冲洗切割部位,而且还有助于清洗每次循环去除下来的在锯齿107上的组织。外套管105的形状具有一个斜边端110,以使锯齿107当切割刀片106在斜边110两端振荡时完全暴露出来。
图5表示了另一种切割用具,它具有一个在外套管110内振荡的组织分碎刀片111。分碎刀片111包括一个碰撞面112。分碎刀片与冲洗导管113一体或固定在其上,而导管113在碰撞面112上有一个开口。外套管110具有一个大得足以使大量组织抽入到外套管110中的组织开口。套管还具有一个一体的相对的碰撞面115,以使组织在分碎刀片111和碰撞面115之间被分碎。施加在外套管内的真空有助于将组织保持在组织开口114内,这种组织分碎刀片115可用于柔软或坚硬织织。
现在参考图6,表示本发明的一个具体实施例的电路图。在该图中,与图1所示的相同的附图标号表示相同的部件。电路板119具有多个电阻及线路,以集合各种开关、可控元件、及传感器输入。控制旋钮70和71与其可变电阻或变阻元件一起被示出,而这些元件被用于调节施加在各自的可控阀32和42上的电压。直到脚踏板60被踩到足以闭合开关61的程度进而将信号传至开关70的变阻元件上时,控制旋钮70才被启动。同样,直到通过踩下脚踏板60使开关63被驱动时,切割速度控制旋钮71才被启动。
抽吸/真空控制设置由于其具有两个开关而被更多些地涉及到。当通过踩下脚踏板60而被驱动时,第一个开关62只启动传到可控阀32的信号线。可变开关62A沿着阀控制线55将信号传给可控阀32,以使操作者直接调节由真空发生器28产生的真空度。
系统的电路允许接收来自抽吸压力传感器65和冲洗压力传感器67的感应信号。在该图中,抽吸压力传感器65被表示成接入到真空发生器28和废物收集器25之间的真空线29中。确定沿着线66的传感器输出信号,该信号与施加在系统抽吸回路中的真空值直接相关。沿着线66从压力传感器65通至控制元件的感应信号为可控电源121提供了即时反馈;以便将真空保持在由可变开关62A设置的值上。同样,沿着线66从冲洗压力传感器67传来的感应信号为可编程电源121提供了反馈,以便将冲洗压力和流速保持在由控制旋钮70设置的值上。如前面所讨论的,节流阀37同样也是由沿着线54的一个信号所控制的。
根据本发明的具体实施例,电源120包括可变或可编程电源121,它可以改变施加给电路板119和系统其它元件上的电压。电源120还直接为手柄53提供了能量,以驱动手柄内的声控线圈电机。
虽然在附图及前面的描述中已详细说明和描述了本发明,但是这都应被适当地视为是示意性的和非限定性的,应该理解的是,这里只表示和描述了优选实施例,希望所有属于本发明精神范畴内的改变和改进都能得到保护。
Claims (12)
1.一个用于最低限度创伤的经皮组织去除系统,包括:a)一个组织切割用具,具有:
一个手柄;
一个细长套管,其大小适于被经皮引入体内并具有一个近端和一个相对的远端,所述套管在所述近端由所述手柄支撑着并在所述远端限定了一个切割开口,所述套管还限定了一个贯穿所述近端到所述切割开口的抽吸通道;
一个切割刀片,它被可滑动地安装在所述远端附近的所述套管内,以便通过所述切割开口;
与所述切割刀片相配合的驱动装置,用来使所述切割刀片跨越所述切割开口往复运动,进而伸入到所述切割开口内的组织被通过开口的所述切割刀片切下,被切下的组织被送到所述抽吸通道;b)一个抽吸回路,包括:
一个用来容纳被所述切割刀片切下的组织的废物容器;
一个将所述抽吸通道与所述废物容器相连的管道,用来将被切下组织从所述抽吸通道送至所述废物容器内;以及
真空发生装置,用来通过废物容器,所述导管和所述抽吸通道产生一个真空,以便将被切下组织抽入到其中;c)一个冲洗回路,包括:
一个冲洗液源;
用于使冲洗液从所述液源流到所述套管的所述远端的装置;和
加压装置,用来对从所述液源流至所述套管的所述远端的冲洗液进行加压;和d)控制装置,用于控制所述真空发生器和所述加压装置,包括:
输入装置,用来为抽吸真空值和冲洗压力提供预置值;
用来根据来自所述输入装置的所述预置值产生一个抽吸控制信号和一个冲洗控制信号的电路;
响应于所述抽吸控制信号的装置,用于控制所述真空发生装置产生并保持与所述预置的抽吸真空值相等的真空;以及
响应于所述压力控制信号的装置,用于控制所述加压装置对冲洗液进行加压并保持在所述预置压力值上。
2.如权利要求1所述的组织去除系统,其中:
所述真空发生装置包括用来产生一个响应于由所述真空发生装置接收到的气体压力的真空;以及
所述控制装置包括:
一个高压气源;
一个第一可控阀,它具有一个入口和一个出口,并将所述入口与所述高压气源相接,所述第一阀具有响应于所述抽吸控制信号的装置,用来可控制地降低所述入口处接收到的高压气体的压力并相对地将在出口处释放相对降低了压力的气体;和
一个将所述第一阀的所述出口连到所述真空发生装置上的连接装置,用于将降低了压力的气体提供给所述真空发生装置。
3.如权利要求2所述的组织去除系统,其中所述冲洗液源包括一个内含大量液体的弹性容器,它具有一个与所述的用于使冲洗液流动的装置相连接的出口;和
所述控制装置进一步包括;
一个圈绕所述弹性容器并具有一个接收加压液体的入口的压力套筒;和
一个第二可控阀,它具有一个入口和一个出口并在所述入口处与所述高压气源相接,所述第二阀具有响应于所述压力控制信号的装置,以便可控制地降低在入口处接收到的高压气体的压力并在所述出口处释放相对降低了压力的气体;
所述第二阀的所述出口与所述压力套筒的所述入口相连,以便向所述套筒提供所述降低了压力的气体,进而所述套筒内的压力对所述弹性容器及其内所含液体进行加压。
4.如权利要求3所述的组织去除系统,其中所述控制装置包括:
用于感应在所述组织切割用具处的所述冲洗回路内的液体压力并响应于所述感应到的液体压力而产生一个信号的装置;及
用来将所述感应的压力信号与所述的预置的冲洗压力值进行比较的装置,如果所述感应的压力信号小于所述预置值的话就增加冲洗液压力,而如果所述感应压力信号超过所述预置值的话就降低冲洗液压力。
5.一种用于最低限度创伤的经皮组织去除系统,包括:a)一个组织切割用具,包括:
一个手柄;
一个由所述手柄支撑的电机,所述的手柄具有产生线性往复运动的装置;
一个细长的套管,其大小适合于被经皮引入体内,并具有一个近端和一个相对的远端,所述套管由所述手柄的所述近端支撑并在所述远端处限定了一个切割开口,所述套管还限定了一个贯穿所述近端到所述切割开口的抽吸通道;
一个可滑动地安装在所述远端附近的所述套管内的切割刀片,用于穿过所述切割开口;
与所述切割刀片相配合的驱动装置,用来使所述切割刀片穿越所述切割开口往复运动,进而使伸入到所述切割开口中的组织被通过开口的所述切割刀片切下,将被切下的组织送到所述抽吸通道;b)一个抽吸回路,包括:
一个用来容纳被所述切割刀片切下的组织的废物容器;
一个将所述抽吸通道与所述废物容器相连的管道,用来将被切下组织从所述抽吸通道送到所述废物容器;以及
真空发生装置,用来通过废物容器,所述导管和所述抽吸通道产生一个真空,以便将被切下的组织抽入到其中;c)一个冲洗回路,包括:
一个冲洗液源;
用于使冲洗液从所述液源流至所述套管的所述远端的装置;和
加压装置,用来对从所述液源流至所述套管的所述远端的冲洗液进行加压;以及d)用于控制所述真空发生器的控制装置,包括:
输入装置,用来为抽吸真空水平提供一个预置值;
用来根据来自所述输入装置的所述预置值产生一个抽吸控制信号的电路;
响应于所述抽吸控制信号的装置,用于控制所述真空发生装置产生一个等于所述预置值的真空;以及
操作者控制装置,用来可变地控制所述真空发生装置,以便产生一个最高达所述预置值的可变真空,以使操作者能够利用通过所述抽吸回路的可变真空有选择地将组织抽入到所述切割开口内。
6.一种采用一个具有驱动切割刀片穿过在经皮引入套管内的一个切割开口的往复运动电机的切割用具,从人体中切除目标组织的方法,包括:
确定目标组织和周围组织的特性,这些特性包括目标组织和周围组织的弹性和强度;
根据相应组织的特性确定目标组织和周围组织的特征频率;
控制切割用具电机,以使切割刀片以目标组织的特征频率穿过切割开口往复运动,进而切割抽入到切割开口内的目标组织而不会切割周围组织。
7.如权利要求6所述的目标组织切除方法,其中切割用具包括一个在切割开口附近具有其入口的抽吸回路,该方法还包括一个步骤:当切割刀片切割目标组织时向抽吸回路提供真空抽吸,以去除被切下的组织。
8.如权利要求6所述的目标组织切除方法,其中提供真空抽吸的步骤包括可变地控制抽吸回路中的真空,以便可控制地将组织抽入到切割用具的切割开口中。
9.一种用于经皮组织去除的手术锉刀,包括:
一个手柄;
一个由手柄支撑的电机,该手柄具有产生线性往复运动的装置;
一个细长套管,其尺寸适于被引入到人体内,所述套管具有一个近端和一个远端,所述套管在其近端由所述手柄支撑,且在其远端处具有一个切割开口,
一个与所述电机相连并通过所述套管延伸到所述切割开口的管状驱动轴,所述驱动轴在其中限定了一个冲洗通道;
用于通过所述冲洗通道提供冲洗液的冲洗装置;以及
一个安装在所述驱动轴上的锉刀刀片,所述锉刀刀片包括多个锯齿并在所述锯齿之间限定了几个与所述冲洗通道相连通的开口,其中所述锉刀刀片可滑动地设置在所述远端处的所述套管内,而所述多个锯齿通过所述切割开口延伸。
10.权利要求9所述的手术锉刀,其中所述套管具有一个圆形顶端,并且所述切割开口伸入到该圆形顶端内以使所述锉刀刀片的一部分暴露到所述套管的所述远端以外。
11.一种用于经皮组织切除的组织分碎器,包括:
一个手柄;
一个由所述手柄支撑的电机,该手柄具有产生线性往复运动的装置;
一个细长的套管,其大小适于被引入到人体内,所述套管具有一个近端和一个远端,所述套管在其近端由所述手柄支撑而在其远端具有一个组织引入开口,并且在朝向所述引入开口的所述远端处还具有一个端面;
一个与所述电机相连并通过所述套管伸入到所述引入开口的管状驱动轴;以及
一个与所述驱动轴相接并具有一个相对于所述套管的所述端面设置的碰撞表面的组织碰撞器,进而当所述碰撞器被所述电机驱动而往复运动时,伸入到所述引入开口的组织被夹在所述端面和所述碰撞表面之间。
12.如权利要求11所述的组织分碎器,还具有一个抽吸回路,它包括:
一个真空源;
一个被限定在所述套管或所述驱动轴内的抽吸管道,所述管道与所述真空源液体耦连,并在所述组织引入开口处具有一个入口开口,进而由所述真空源通过所述抽吸管道施加的真空将通过所述套管内的所述引入开口的组织以及在所述端面和所述碰撞表面之间的组织抽入。
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Cited By (19)
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Also Published As
Publication number | Publication date |
---|---|
EP0686013A4 (en) | 1997-12-29 |
AU6172394A (en) | 1994-09-14 |
US5403276A (en) | 1995-04-04 |
JPH08509397A (ja) | 1996-10-08 |
US5685840A (en) | 1997-11-11 |
WO1994018894A1 (en) | 1994-09-01 |
JP3558634B2 (ja) | 2004-08-25 |
EP0686013A1 (en) | 1995-12-13 |
US5669876A (en) | 1997-09-23 |
ZA94865B (en) | 1994-08-23 |
CA2156189A1 (en) | 1994-09-01 |
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