CN1119418A - 经由尿道的针式切除装置和方法 - Google Patents
经由尿道的针式切除装置和方法 Download PDFInfo
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- CN1119418A CN1119418A CN94191468A CN94191468A CN1119418A CN 1119418 A CN1119418 A CN 1119418A CN 94191468 A CN94191468 A CN 94191468A CN 94191468 A CN94191468 A CN 94191468A CN 1119418 A CN1119418 A CN 1119418A
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- needle electrode
- parts
- distal head
- prostate
- sheath
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Abstract
一种利用射频能治疗男性前列腺的经由尿道的针式切除装置(31),它包括一个鞘(32),此鞘具有在其中延伸的内腔(36);一个可滑动地安装在该鞘腔中的导管组件(51,52),该导管组件有一个在其中延伸的内腔;一个可滑动地安装在导管组件内腔(84)中的针电极(116)。一个隔离套管(83)设置在针电极周围,并且使针电极的远端头露出,这样当鞘被置于尿道中且其远端头位于前列腺附近时,可以推进针电极穿过尿道壁,进入前列腺的组织中,从而能将射频能施加到包围着针电极的前列腺组织上以便在前列腺中形成一个损伤。
Description
本申请是1993年8月19日递交的申请号为08/109,190的申请的一个部分继续申请,该08/109,190号申请是1993年5月13日递交的申请号为08/061,647和08/062,364的申请的一个部分继续申请,08/061,647号和08/062,364号申请是1993年2月2日递交的申请号为08/012,370的申请的部分继续申请,而08/012,370号申请是已放弃的、在1992年8月12日递交的申请号为07/929,638申请的一个部分继续申请。
本发明涉及用于治疗男性前列腺病的一种带膀胱镜的经尿道的针式切除装置和方法。
良性前列腺肥大或增生(简称BPH)是男性老年人的一种常见病。在此之前用于治疗这种病的外科手术一直很昂贵、费时而且使病人感到痛苦。此外,这种外科手术还会造成许多不利的副作用。因此需要有一种克服这种缺陷的装置和方法。
总体上来说,本发明的目的是提供一种带膀胱镜的经尿道的针式切除装置和方法,可以用来治疗男性前列腺病,尤其是BPH。
本发明的另一个目的是提供一种具有上述特征的应用射频能量的装置和方法。
本发明的另一个目的是提供一种具有上述特征的装置和方法,其中在施行切除手术期间尿道受到保护以免受射频能的损伤。
本发明的另一个目的是提供一种具有上述特征的装置和方法,其中针电极不会穿透隔离套管。
本发明的另一个目的是提供一种具有上述特征的装置和方法,其中设置了组织免遭不希望的破坏的控制部件。
本发明的另一个目的是提供一种具有上述特征的装置和方法,其中提供了许多安全性的特征。
本发明的另一个目的是提供一种具有上述特征的装置和方法,其中可以在针电极不移动位置的情况下撤回隔离套管。
本发明的另一个目的是提供一种具有上述特征的装置和方法,其中尿道壁的撑张减至最小程度。
本发明的另一个目的是提供一种具有上述特征的装置和方法,其中在将该装置引入病人体内之前,可以预先设定暴露在前列腺内的针电极的长度和隔离套管相对于针电极的位置。
本发明的另一个目的是提供一种具有上述特征的装置和方法,其中设置了一种制动机构,用于在缩回隔离套管时使针电极保持在其位置上。
本发明的另一个目的是提供一种能够被实施该手术的医生容易地使用的装置和方法。
本发明的另一个目的是提供一种具有上述特征的装置和方法,它能够采用常规的膀胱镜。
本发明的另一个目的是提供一种具有上述特征的装置和方法,其中配置一个整体的膀胱镜。
本发明的另一个目的是提供一种具有上述特征的装置和方法,它侵入性极小,有效且成本低。
本发明的另一个目的是提供一种具有上述特征的装置和方法,它能够用来有选择地切除前列腺组织。
本发明的另一个目的是提供一种具有上述特征的装置和方法,它能够将低水平的射频功率直接输送到前列腺的一个局部区域上。
本发明的另一个目的是提供一种具有上述特征的装置和方法,其中,可以用径直肠的超声波或者肉眼直接观测方式使装置定位。
本发明的另一个目的是提供一种具有上述特征的装置和方法,其中通过监测尿道的温度来保证了安全。
本发明的另一个目的是提供一种具有上述特征的装置和方法,其中能够实现严重的凝结性局部坏死的大损伤。
本发明的另一个目的是提供一种具有上述特征的装置和方法,其中病人能够不用麻醉(除了可能的使用一种局部麻醉剂外)而进行治疗。
本发明的另一个目的是提供一种装置和方法,其中,针电极能够沿与导管纵轴线大体成直角的方向引入并使之穿透尿道壁,直接延伸到前列腺组织中。
本发明的另一个目的是提供一种具有上述特征的装置和方法,其中至少能够在前列腺组织中基本上同时地造成两个损伤。
本发明的另一个目的是提供一种具有上述特征的装置和方法,其中针电极能够很容易地重新布置,以便在同一前列腺中产生另外的损伤。
本发明的另一个目的是提供一种具有上述特征的装置和方法,其中形成损伤的切除操作能够极其精确地实施。
本发明的其它目的和特征在以下的说明书中给出,此处结合附图对本发明的最佳实施例进行描述。
图1是一个桥接件的一个侧视图,此桥接件上连接一个鞘,该鞘装有一个常规的膀胱镜。
图2是一个手柄和导管组件与图1中所示的桥接件以及装有一个常规膀胱镜的鞘一起使用时的一个侧视图,这种配合提供了包含本发明的一种经尿道的切除装置。
图3是沿图2中3-3线观看的一个顶视图。
图4是图2中所示导管组件的远端头在箭头4-4所圈的部分的一个放大的局部剖视图。
图5是导管组件的远端头沿图6中的5-5线截取的局部剖视放大详图。
图6是沿图5中6-6线截取的一个剖面图。
图7是沿图5和8中的7-7线截取的一个剖面图。
图8是包含本发明的一个导管组件的另一个实施例的远端头的一个局部剖视图。
图9是沿图1的9-9线截取的一个剖视图。
图10是沿图1的10-10线着的一个视图。
图11是沿图10的11-11线截取的一个剖视图。
图12是沿图2的12-12线看的一个视图。
图13是沿图2的13-13线看的一个视图。
图14是沿图15的14-14线截取的一个类似于图13的放大视图,其中一些部分被截掉。
图15是沿图14的15-15线截取的一个剖视图。
图16是沿图15的16-16线的一个剖视图。
图17是沿图16的17-17线取的一个剖视图。
图18是沿图17的18-18线取的一个剖视图。
图19是沿图13的19-19线取的手柄组件的一个剖视图,它示出处在工作状态的安全机构。
图20是类似于图19的一个剖视图,但示出处于脱离啮合状态的安全机构。
图21是沿图19的21-21线截取的一个剖视图。
图22是沿图19的22-22线截取的一个剖视图。
图23是沿图19的23-23线观看的一个视图。
图24是图23中所示机构的一个等角分解图。
图25是沿图24的25-25线截取的一个剖视图。
图26是沿图15的26-26线截取的一个部分剖视图。
图27是沿图26的27-27线截取的一个剖视图。
图28是沿图26的28-28线截取的一个剖视图。
图29是表示应用经尿道的针式切除装置实施一个切除手术的方式的一个示意图。
图30是经尿道的针式切除装置的远端头的一个放大剖视图,示出了在切除手术期间针电极定位的情况。
图31是沿图30的线31-31看的一个视图。
图32是一个放大的剖视图,它示出了其中一个针电极穿透尿道壁并产生一种撑张效应。
图33是一个类似于32的剖视图,但它示出了隔离套管相对于针电极处于缩回状态并消除了尿道壁中的撑张效应。
图34是一个湿度梯度图,示出了在一个切除手术期间前列腺组织中出现的温度。
图35是本发明的一个经尿道的针式切除装置的另一个实施例的一个视图。
图36是沿图35的36-36线截取的一个剖视图。
图37是沿图35的37-37线截取的一个剖视图。
图38是沿图37的38-38线截取的一个剖视图。
从总体上来说,该经尿道的针式切除装置应用射频电源的射频能治疗男性的前列腺。所述的男性具有一个带底部的膀胱,一个前列腺和一个阴茎,该阴茎中有一条由尿道壁形成的尿道,尿道从膀胱底部沿着前列腺的纵轴线延伸,穿过前列腺和阴茎。前列腺有包围着尿道壁的前列腺组织。该装置包括一个鞘,该鞘有一个近端头和一个远端头以及一个从近端头延伸到远端头的内腔。鞘的内腔中装有一个可滑动的导管组件,该导管组件有一个近端头和一个远端头和一个纵轴线。在导管组件的腔中装有一个可滑动的针电极(或称电极针),该针电极有近端头和远端头,导管组件腔内还有一个围绕针电极设置的隔离套管,该隔离套管有近端头和远端头,其远端头设置在能使针电极暴露出来的位置处。设有可供人手握住的手柄部件。一个桥接件固定在手柄部件上并连接到鞘的近端头上,以便将手柄连接到鞘的近端头上。在手柄和桥接件上装有与导管组件相连的部件,用于从位于鞘的远端头内的一个缩回位置和远离鞘的远端头的一个伸出位置移动导管组件的远端头。装在手柄部件上并连到导管组件的部件用于使导管组件的远端头相对于其纵轴成弯曲一个角度,由此使导管组件中的腔定向而面对尿道壁。装在手柄上并与针电极和隔离套管相连的部件,用于使针电极相对于导管组件进行伸缩。使针电极与射频电源相连的部件,以便当鞘位于尿道中并且其远端头在前列腺附近时将射频电源的射频能施加到针电极上,使前列腺组织中造成一个损伤(烧蚀)。
本发明的治疗男性前列腺良性肥大的方法(此处所述男性有一个带底部的膀胱,一个前列腺和一个阴茎,阴茎中有一条由尿道壁构成的尿道,它从膀胱底部延伸,沿着一个纵轴线穿过前列腺和阴茎,前列腺具有包围着尿道壁的组织)包括以下步骤:将针电极插入尿道并在尿道的纵向上沿纵轴线伸进,直到靠近前列腺。然后将针电极沿着一个与尿道壁纵轴线成相当大的角度的方向推进,以便穿透尿道壁而延伸到前列腺组织中。将射频能在一个足够大的功率水平下施加到针电极上并维持足够的时间,以便提高在针电极附近的前列腺组织的温度,从而在前列腺组织中造成一个损伤。
更具体地,如图1-31中所示,可以称为TUNA III的经尿道的针式切除装置包含一个刚性的鞘32,它可以是一种合适类型和大小的鞘,例如它可以是22号法国(French)导液管状的输送装置,其长度为25厘米。鞘32可以用一种合适的材料制成,例如用不锈钢,并且有近端头33和远端头34以及从近端头延伸到远端头的一个腔36(见图9)。尤其如图1中所示,远端头34有一个向前和向上延伸的曲面38,一个倾斜口39穿过该曲面38(见图33)。远端头34还具有一个增厚部分34a,为鞘32提供一个钝的头,使之能在后面要描述的切除过程中进入前列腺中的尿道中。
在鞘32的近端头33上装有一个套节41,该套节41的相对两侧上都装有一个小龙头42。一个锁环43可转动地装在套节41上,锁环上还设有一个柄杆44,可以用于安装鞘32的近端头33,如后面要描述的那样。
第一和第二导管组件51和52被可滑动地装在鞘32的腔36中。两个导管组件51和52基本上是相同的,并且如图所示是并排设置在腔36中,并用合适的材料如焊料53固定在一起。
图6中示出导管组件51的一个横截面视图。如图中所示,该导管组件51以及类似的导管组件52是由一个用一种合适材料(如不锈钢)制作的具有15号量规(15gauge)的壁厚且外径为0.072英寸和内径为0.060英寸的外导管56组成。该外导管56具有近端头57和远端头58。近端头57处装有一个凸缘59。一起纵向相间的、沿周向延伸的L形缝口61设置在外导管56的远端头的最远端处,例如在最后的1.5厘米范围中。缝口61所对的角小于360°,并具有一个合适的宽度,例如0.012英寸,相互相间的一个适合的间距,例如0.033英寸。缝口61是L形的,并具有一个长度为0.010英寸的趾部或短腿部61a。缝口61不是径向错开设置的,因此提供了一个沿外导管56纵向延伸的支柱或肋62。外导管56具有合适的长度,例如14英寸,缝口61设在最远端的0.5英寸的部分58a中。一个内导管66设置在外导管56的远端头58内,并具有一个合适的长度,例如0.7英寸。它也是用一种合适规格例如17号厚度的不锈钢制作的,并且外径和内径分别为0.059英寸和0.041英寸。一些纵向相间的、沿周向延伸的L形缝口67设置在内导管66中并且它们的尺寸与外导管36中的缝口61相同。缝口67在纵向与缝口61对齐。缝口67也在轴向上对齐,因此支柱68与支柱62对齐(见图6)。内导管66在其外表面上有一个在其长度上延伸的平面71。当内导管66安装在外导管56中后,在外导管56的内表面和平面71之间就形成一个横截面呈弓形的空隙72(见图6),以提供设置一个拉带76的空间。拉带76的远端头76a与固定在外导管56的远端头58内的一个横跨77相搭接(见图5)。上述导管组件51和52采用一种在共同待审的专利申请(申请号08/174791,申请日1993年12月29日)中公开的结构。
隔离管组件81和82被可滑动地安装在导管组件51和52中。这两个组件81和82基本上是相同的。隔离管组件81包含一个用一种合适材料例如19号厚度薄壁管(常称为皮下注射管)不锈钢制成的隔离管83,其外径为0.043英寸,内径为0.033英寸。管83有一个大的内腔84(见图5和6)。一个由合适材料例如11号尼龙制成的套管86顶接在不锈钢钢管83的远端头上,并提供了一个大腔87和一个较小的腔88,这些腔通向管83的大腔84。套管86以合适的方式,例如用一种粘胶剂(未示出)固定在管83和一个收缩管89(热套管)上,该收缩管89在套管86的近端头和管83的几乎整个长度上延伸,亦即距离管83的径向延伸的凸缘90的距离为0.25英寸之内的范围上延伸,通过在套管86的远端头上加热而形成例如用11号尼龙材料制成的隔离管的管头91,管头内有一个内腔92与腔87对齐。管头91有一个锥形表面93,它向内向前朝着远端头延伸,在240°的周面上的向前延伸的长度约小于管头91总长的一半。一个锥度更缓的锥面94,约与水平方向或15℃,设置在其余的120°的周面上,并在管头91的长度上延伸,如图5中所示。
一个热电偶(96)埋设在管头91内并与带绝缘的导体97相连。该导体穿过套管86中的腔88和管83的腔84。
为了在隔离管组件81的远端头弯曲时避免蠕变,收缩管89的内部粘接在不锈钢管83上并且也粘接在隔离套管86的外部上。
可以替代组件81和82的一个隔离套组件的另一个实施例示于图7和图8中。在图中所示的隔离管组件101包含一个与前述皮下注射管83类似的皮下注射管102,并且有一个穿过组件101的腔103。一个隔离管112装配在皮下注射管102的远端头上并在其中有一个腔113,该腔能容纳皮下注射管102的远端头。隔离管112的远端头配有一个附加的腔114,该腔中设有一个足够大小的心轴(未示出),用于容纳热电偶96的两个导体97。类似地,在远离皮下注射管102的腔113中设置另一个心轴,以提供一个合适大小的腔,例如0.018英寸。当装入心轴以及将其近端头夹紧在皮下注射管102的远端头上后,隔离管112在低热下伸展到原始长度的大约150%。然后将心轴移来。热电偶96可以安装在腔114中,端部用适当的方式例如用一种热密封件进行密封。热电偶上的导体97在腔114的近端处延伸通过一个设在隔离管112中的孔115(见图8),从而热电偶导体97可以进入皮下注射管102的内腔103。已经发现,隔离管112的这种伸展是有益的,因为伸展使在隔离管中应用的塑料树脂定向。因此,隔离管具有一个较高的挠曲模量和一个较高的拉伸屈服强度。这种伸展也增大了管112的耐温度强度,几乎提高30℃。此外,伸展使隔离管尺寸缩小,因此它能很好地装配在不锈钢皮下注射管102的端部上。利用这种结构可以取消前实施例中的收缩管89。
一个针电极116被可滑动地安装在隔离管83的腔84中并延伸穿过管头91的内腔92。针电极116用一种合适的材料制作,如一种具有超弹性特性的镍钛合金,因此当它被弯曲后可以恢复到原始形状,如后述的那样。它有一个尖端117,可以容易地穿透组织。针电极116有一个合适的直径,例如略小于内腔87和92,例如直径为0.017英寸。
经尿道的针式切除装置31(见图1)也包含形状为手柄121的手柄部件,其大小设计得能为成人的手所握住。手柄121有近端头和远端头或称前端头122和后端头123。设有将导管组件51和52以及隔离套组件81和82的手柄121的各近端头相接的部件,以便提供一个如图2中所示的手柄和导管组件124,如后文要描述的那样,壳126的下部126b上设有横向延伸、纵向相间的齿形面127,便于用手保持住壳126。
手柄121包含一个由一个上部126a和一个下部126b构成的壳126(见图15)。该壳126由一种合适的塑料制成,例如用聚碳酸酯制做。四个滑动控制件131,132,133和134(由左至后数)被可滑动地安装在壳126的顶面135上(见图13和15),并能在表面135的纵向上移动。为了使滑动控制件之间相互能区别开来,可以对滑动控制件做颜色编码和做成不同的形状便于用触觉来区分。这样,可以为它们配置竖立的凸起,其中外侧的滑动控制件131和134分别配置了竖立的顶部、截断的三角部分131a和134a。类似地,滑动控制件132和133具有三角形的竖立部分132a和133a。当采用颜色编码时,两个外侧滑动控制件131和134可以作成蓝色的,而内侧滑动控制件132和133可以作成灰色的。
两个外侧滑动控制件131和134可以用来控制隔离套组件81和82的移动,类似地,滑动控制件132和133可以用来控制针电极116的移动。滑动控制件131-134配置有向内延伸的凸起部分131b,132b,133b和134b(见图14),它们穿过纵向延伸的、相间的并成形于上部或盖126a中的平行缝口136(见图14)。缝口136通入四个纵向延伸并相间的平行凹槽137中(见图14),这些凹槽形成于向下和纵向延伸的、与上部或盖126a构成一体的肋138之间。滑动件141、滑动件组件142和143和滑动件144被可滑动地安装在凹槽137(见图14)中。以便做纵向移动,滑动件141和144设计成镜面对称的。类似地,滑动件组件142和143也设计成镜面对称的。滑动件和组件141,142,143和144都配置长条形凹槽146(见图14),凸起部分131b,132b,133b和134b扣接在这些凹槽中,与之形成摩擦配合。
滑动件141和144配有突出部分151,它们置于插进肋138的下面并横过滑动件组件142或143的近端头(见图14)。还设有置于滑动件组件142或143下面的支承部分152和一个悬垂部分153。滑动件组件142或143包含一个滑动件156,它的一端有一个支承部分157,该支承部分157置于滑动件141或144下面。滑动件156中加工有相邻的长条形凹槽158和159,且前者比后者深。另一个弧形凹槽161成形于滑动件156中长条形的凹槽158的底部,该凹槽161中的两个相对的端部处设置制动件162和163,它们用一种合适的材料制成(例如聚碳酸酯),它们之间装有一个螺旋弹簧166。一个盖166(见图14)设置在凹槽158和159中并可以在凹槽158和159中滑动,以便利用两个销167在凹槽158和159的纵向上移动。销167固定在滑动件156中的盖166的相对的两侧并被可滑动地安装在盖166中。盖166有一个悬垂部分166a(见图17),它可以滑动地支承在凹槽159中并能使盖166做前后移动,例如移动0.004英寸,以将制动机构从一个制动位置移到一个非制动位置。因此,如后文所述的那样,通过移动盖166,制动件162和163可以在制动啮合位置和非制动啮合位置之间移动。
滑动件156的另一端配有一个向下延伸的突出部分168和一个横向延伸的隔离止动释放臂169,该臂用于后文要描述的一个目的。
一个也是用聚碳酸酯材料制成的U形夹持件171固定在上部或用热桩固定在与壳顶部126a形成一体的柱件172处,并置于滑动件141和144和滑动件组件142和143下面。U形夹持件171配有向上延伸的突出部分173,如后文要描述的那样,在启动滑动控制件131-134期间,这些突出部分173能与斜面174相啮合(见图17)。
提供了将隔离套组件81和82固定到滑动控制件141和144上的部件,该部件包含焊接到正好在隔离管89近端处的不锈钢管83上的金属薄片181。这些薄片181用螺丝182固定在滑动件141和144的支承部分152上。
提供了将针电极116固定到滑动件组件142和143上的部件,该部件包含焊接到正好在隔离管118的近端处的电极116上的金属薄片186。这些薄片186固定到滑动件156的支承部件157上。带绝缘的电导体191固定在螺钉187上,从而它们与薄片186和针电极116处于电接触状态。导体191延伸穿过一个设置在壳121中的孔圈192和一个与壳121相连的电缆193。类似地,两组热电偶线97延伸穿过电缆193和孔圈192进入一个带螺旋狭缝的保护套194,然后进入一个套筒196。在电缆193中,热电偶线97分叉进入另一根电缆197(见图29)。
壳126上支承一个由两部分构成的壳延长部分198,它由一种聚碳酸脂制成,用于后文要描述的目的。该延长部分198由具有凸缘的部分126c和126d夹紧在壳126上并支承在围绕壳延长部分198延伸的一个凹槽199中(见图20-21)。壳延长部分198配有一个圆柱形延伸部201,它可以用一种合适的材料例如聚碳酸脂制成。壳126的圆柱形延伸部201可以与后文描述的一个桥接件206相配接,该桥接件上安装了前面所述的鞘32。圆柱形延伸部201有一个内腔211(见图11和23),导管组件51和52的近端头进入该内腔211中并且向外张开,如图所示(见图3)。
提供有连到导管组件51和52的近端头上的部件,用来启动装在其上的拉带76,并装在手柄上且与导管组件相连接,用来使导管组件51和52的远端头相对于纵轴线弯曲一定的角度。该部件包含设置在壳126的相对的两侧上的第一和第二杆组件216和217,这两个组件是相同的,因此只描述其中的一个组件。杆组件216包含一个圆柱形钮218,它由一个螺丝219可转动地安装在一个臂220的一端上。臂220与可转动的部件221做成一体,部件221中有一个方孔222(见图19)。一个齿销盘226可转动地安装在壳延长部分198中的一个圆柱形凹槽224中(见图24)。盘226上设有一些沿圆周上相间的齿228,它们可以与柱塞229啮合,柱塞229受一弹簧作用而被可缩进地向外推,进入一个圆柱形螺纹部件231中,该螺纹部件231旋入壳延长部分198中的一个螺纹孔232中。盘226上有一个方形凸起234,它穿过壳延长部分198的壁,装配在圆柱形部件221的方形孔222中,从而能够通过在两个顺时针和逆时针极端位置之间移动杆臂220而转动销盘226。盘220还有一个竖立的销236,该销236设置在一个横向延伸的位于一个矩形滑块238中的缝口237中,滑块238可滑动地安装在一个位于圆柱形凹槽227上方的长条形凹槽241中,以便做往复运动。滑块238有一个在其纵向延伸的缝口242,该缝口242与壳126中的一个弓形缝口243对齐,弓形缝口243通入圆柱形延伸部201的内腔202中。
外导管56的近端头的近端凸缘59装在壳延长部分198的一个缝口240中。在凸缘59附近延伸的启动带或拉带76延伸到一个调节块246中的一个孔244内,调节块246有一个可以在缝口242中纵向移动的腿247。提供了将启动带76保持在孔244中的部件,它包含一个用合适材料如不锈钢制成的管形件249,可以用压配合安装在孔244中,将拉带(76)的近端头保持在其中。
提供了用于相对于滑块238调节拉带的部件,它包含一个有帽螺钉251,该螺钉可以经螺纹旋入滑块238中的螺纹孔252中。调节块246有缝口254,它与螺纹孔252对齐并有一个横向延伸的缝口256位于缝口254两端的中间,用于容纳有帽螺钉251的头部。因此可以用普通的螺丝刀来调节有帽螺钉251,就可以调节调节块246相对于滑块238的纵向位置,从而调节启动带76的长度和弯曲度,这种弯曲在移动杆臂组件216或217的杆臂220时可能会发生。
在工作中,可以看到,使有帽螺钉251逆时针转动以松动螺钉时,将使调节块246缩回或将其从滑块238处推开,由此张紧拉带76。在反向上转动有帽螺钉则使相反的情况发生。在作了适当的调节后,可以看到,杆臂220的转动将使销236滑入缝口237中,以调节滑块238,从而它在长条形凹槽241的纵向上移动,引起带的移动,而使相联的导管组件的远端头弯曲,如后面描绘的那样。弹簧加载的柱塞229与齿228相啮合,部分地限制了盘226的转动并用作当臂220被转动到所出现的角度值(例如从0°至30°,从60°至90°等等)时给医生一个物理提示。
桥接件206包含一个桥接壳261,该壳由一种合适的材料如聚碳酸脂制成(见图1,10和11)。套263安装在该壳中,套263可通知一种合适的材料如不锈钢制做。套的远端头上有一个外螺纹延伸部264(见图1),它能与鞘32的近端头33上的锁环43相配。套263有一个在其中延伸的圆柱形内腔(未示出),用于容纳一个普通的膀胱镜271。该膀胱镜271典型情况下是一种能重复使用的直接观测装置,其上配有一个圆柱形不锈钢光管272,该光管可以以滑动配合装在桥接件206的套263内。这种光管272对于本领域专业人员是公知的,它含有一些棒状光学元件(未示出),以提供在管272远端头273处的良好的可观测性。管272的大小被选定得能将其容易地装配在鞘32的腔36中,并且能使远端头273设置在紧靠近鞘32远端头处的变曲表面38的后面(见图30)。接头274设置在管272的近端头上并有一个口277,它可以连接上一个光导管278,该光导管连接到一个常规光源279中(见图29)。一个目镜281装在接头274上。
桥接件206中还配有一个向下悬垂的双叉管286,它由两个部分286a和286b构成。双叉管286配有一个通道287,用于容纳导管组件51和52。由图1可见,通道287是一个逐渐变化的曲线形状,它与鞘32中的腔36的下端头对齐,从而导管组件51和52可以容易地进入腔36中并被推进到鞘32的远端头34处,如图30中所示。
相互结合的部件安装在桥接件206和手柄121上,防止在手柄121与桥接件206结合之前针电极116和隔离套组件81和82散开。这种部件包含一个向下延伸的部件296,它在圆柱形延伸部201的纵向延伸。部件296的横截面是矩形的,具有相同的平行的侧表面297和298。它还有一个斜表面301,该斜表面从侧面沿近端方向延伸到从一个前表面302延伸边的侧表面297处。在部件296中设有第一和第二相间平行的缝口303和304,它们向上延伸,穿过侧表面297和298。
一个按钮组件306有一个圆柱形柱塞体307,此柱塞体由一种合适的材料如塑料制成。它被可滑动地安装在相间的、互相对齐的孔308中,孔308开口朝向一个空腔309。柱塞体307有一些设置在空腔309中的相间的凸缘311。弹簧312装在柱塞体307上,其一端支持在凸缘311上,另一端支持在形成空槽309的壁上。这样,弹簧312可收缩地将柱塞体307保持在凹腔309中的一个中点位置上。柱塞体307有一个中心部分307a,该部分大体是矩形截面,其宽度略小于缝口303和304的宽度。中心部分307a配有截面为矩形的槽口316和317,其沿轴向的高度略大于部件296的厚度,其深度大于部件296的宽度。柱塞体307还配有圆柱形按钮部分307b和307c,它们延伸到桥接件206的侧面之外,因此医生可以接触到。
这样,可以看到,当导管组件51和52经内腔288引入通道287,然后推入鞘32的腔36中后,圆柱形延伸部201可以推进到内腔288中,从而斜面301将向侧边顶推按钮柱塞体307,从而克服弹簧312的力使槽口317与部件296啮合。随着圆柱形延伸部201继续向前推进,中心部分307a将与第一槽口303啮合,中心部分307a将在弹簧312的力的作用下从侧边返回与缝口303啮合,从而阻止圆柱形延伸部201进一步向内进入内腔288中。圆柱形延伸部20进一步向内进入内腔288中的情况只有在克服弹簧312的弹力使按钮柱塞体307向侧边推挤后才会出现,从而槽口317或316又被带入与横条296相对齐的状态,之后可以促使圆柱形延伸部201连续地向内移动,直到在弹簧312的力的作用下柱塞体部分307再次移动到槽口304中。
设置了锁定装置以防止如前所述的那样在手柄121与桥接件206相连之前滑动控制件131,132,133和134产生动作。该装置包含一个凸轮释放轴321(见图19),该轴的横截面可以是矩形的,它在手柄121中的一个通道322中延伸。凸轮释放轴321的远端头有一个小柱塞326,它被可滑动地安装在壳126中的一个凹腔327中。
一个第一凸轮件331上支承一些绕枢轴转动地安装在壳126中的销332(见图22)。凸轮件331有一个槽333,它移动面与滑动杆246啮合和脱开。当滑动杆246与槽相啮合时,滑动杆246不能移动。凸轮释放轴321有一个销336,它设置在凸轮件331中的一个缝口337中移动,从而启动凸轮件331。因此凸轮件331可以称为前端或远端凸轮件,而另一个也与凸轮释放轴321相联的凸轮件341可称为后端或近端凸轮释放件。凸轮释放件341上支承一个绕枢轴转动地安装在壳126中的销342(见图21)。凸轮释放件341由一个穿过凸轮释放轴321的销343连接到凸轮释放轴321上,销343在凸轮件341中的一个缝口344中移动,使凸轮件341与U形摩擦轨171啮合和脱开,以将摩擦轨171保持在这样的位置,使得其上的凸轮173不会越过滑动件142或143的斜面174的前端面(见图19)。凸轮件341有两个相同的凸角341a和341b(见图21),它们可以与U形摩擦轨171的两个腿相啮合。凸轮释放轴321的最近端头有一个台肩346,它与一个安装在手柄壳126中的一个凹腔348内的压缩弹簧347的一端相啮合。
这样,可以看到,当销326被支承在内腔288中的圆柱形延伸部201和与销326相啮合的桥接件206克服弹簧347的弹力而压入凹腔327中后,前端凸轮件或第一凸轮件331则被移动,从而槽口334不再与滑动杆238相啮合(见图20),从而允许滑动杆238移动。同时,第二或后端凸轮释放件341被移动到图20中所示位置,以释放摩擦轨171,从而支承在其上的凸轮173能从斜面174上移动过去,由此允许移动拉带76,而能使导管组件51和52的远端头弯曲,并且能使滑动控制件131-134移动,如后文所述的那样。应当认识到前端和后端凸轮件331和341虽然结构上是一致的,但具有横跨壳126宽度的长度,从而手柄121的左右手两侧都通过操作与手柄121两侧上的对应部分相啮合的凸轮331和341来控制(见图21和22),由此控制两个导管组件51和52。
设有在实施后文所述的切除过程中对针电极116的延伸量做可能的预先设定的部件,它也用于预先调节在切除过程中开始应用射频能量之前能够拉出隔离套组件81和82的距离。这种预设置部件包含一个可调节的前端按钮351,它用作后文要述的一种隔离管止动件,和一个可调节的后端按钮352,它用作一种后文要述的针电极止动件,它们安装在壳126中且在该壳的每一侧外(见图2和13)。按钮351和352具有横截面为矩形的心柱353和354,它们穿过壳126的侧壁中的缝口356和357。心柱353和354与按钮351和352是整体件,其上有与之成一体的矩形件366和367,并分别设有齿368和369,这些齿能够与在形成壳126的内壁上的齿371和372相啮合。齿371和372形成互相间隔的静止齿条,它能够与齿368和379相啮合。设置了合适的部件有弹性地将部件366和367朝壳126的外壁方向推进,从而使部件366和367上的齿368和369与齿371和372相啮合。含有与壳126成一体的由一种合适材料如塑料制成的壁部分376和377。当需要使部件366和367上的齿368和369与壳126上的齿371和372脱开时,通过向内压推按钮351和352可以克服这种有弹性的力。
一个紧固臂381支承在部件366上并与之成一体,它也是用一种合适材料如塑料制作的。类似地,一个紧固臂361安装在部件367上。紧固臂361有一个向内延伸的三角形凸起386,该凸起有两个相邻的沿相反方向倾斜的斜面388和389。紧固臂381也有一个安置在其远端头上的向内延伸的凸起391,它提供了一个面对着凸起386的表面389的台肩392和一个沿离开台肩382的方向并与之成一定角度相面对的斜面393。
一个紧固臂382设有一个向内延伸的凸起396,它提供了一个台肩397。在啮合臂部分376和377的区域中的部件366和367设有半圆缺口378和379,用于当部件366和367以及壁部分376和377在缝口356和357中滑动期间以及在对隔离管止动按钮351和针电极止动按钮352定位期间减少部件366和367与壁部分376和377之间的摩擦接触,与按钮351和352一起使用的标尺398和399可以设置在壳126的合适表面上,例如沿着如图13中所示的侧壁上。
在对患有良性前列腺肥大(BPH)的男性病人实施一次手术时,对经尿道的针式切除装置31的操作和使用,现在可以简述如下。接受手术的男性病人401部分地示于图29中,在该图中示出了所涉及的解剖部分,如图所示,它包含一个有一个底部或膀胱颈口403的膀胱402,膀胱颈口通向一个尿道404,尿道404可以看成包括两部分,即前列腺部分404a和阴茎部分404b。前列腺尿道部分404a被前列腺406包围着,该前列腺406是直接位于膀胱下面的腺器官或纤维肌性器官。尿道404的阴茎部分404a通过阴茎407的全长。尿道404由一个尿道壁408构成,它穿过阴茎和前列腺406延伸到膀胱402中。前列腺406可以认为包括五个叶:即前叶、后叶、中叶、左横叶和右横叶。前列腺406也有一个精阜,它是在后文描述的手术期间对本发明的装置31进行定位时在前列腺中的一个特征。
假设在手术准备时,已预先分析了男性病人401的前列腺,用一种数字式直肠检查和径直肠超声波检测了前列腺的大小,在这一检查过程中,通常测量平均和最小尿流量,排泄容积,残余容积和前列腺特种抗原体。典型情况下,该方法最适合于测量横向直径在31毫米和64毫米之间的前列腺。
假设病人的治疗前的评估认为能使用后面要描述的经尿道的针式切除(简称为TUNA)手术,则可以将病人带到一个门诊部或医院的手术室中。脱掉病人401的衣服并在一个手术台上采取一个斜倚的姿势。病人的腿放置在合适的镫子上,以便医生能方便地接近病人的阴部。一个常规的中性电极或接地电极411(见图29)粘在病人的背侧上,使之与病人的皮肤有良好的电接触。该电极用电缆412直到控制台和射频发生器413中。控制台413有一个斜的面板414,其上有适当的数字读出415。一个常规的脚动开关416由电缆417接到控制台内,用于控制后文所述的对频射能量的应用。装置31的手柄121由电缆193和197连到控制台413。
典型地,构成装置31的一部分的鞘32和桥接件206以及膀胱镜271是可重复使用的部件,它们可以在治疗病人的门诊医院或综合医院里获得。只有手柄和导管组件124可为是可处理掉的一类部件,并在使用一次后被处理掉。因此,在手术开始时,手柄和导管组件124从制造商提供的消毒包中取出,了解到要治疗的前列腺406大小的医生对手柄壳126的相对两侧上的可调的前后止动按钮351和352做适当的设置。这样,可调的后止动按钮352结合手柄前端面上的一个标尺399一起设置,标尺399是根据一个TUNA治疗数据表预先由制造商加工在手柄的前端面上,由此设定一个外径为0.017英寸的针电极116的长度,范围为6-20毫米,用于治疗横向尺寸范围为31-64毫米的前列腺。可调的前隔离止动按钮351的位置将配合标尺398来设置,确定隔离套81缩回的量,该套81对上述同样尺寸的前列腺而言其超出尿道壁的范围为4-8毫米。
在操纵按钮351和352中,克服壁部分376和377的可屈服的力而将它们向内推入。一旦按钮351或352被推按到足够远时,例如当按钮351向内推按到使对其支承的部件366上的齿368移动到与壳126上的齿371相啮合时,隔离止动按钮351就可以在壳的纵向上移动到相对于标尺的所希望的位置上,引起紧固臂381移动。一旦按钮351前移到按照标尺398的所希望的立置上,就可以释放开该按钮351,以允许部件366上的齿368再次与壳126的壁上的齿371重新啮合。
类似地,通过向内推按按钮352,使部件367上的齿369移动克服壁部件377的可屈服力而与壳126的壁上的齿372脱离啮合,从而能够调节针电极的止动按钮352。一旦结束这一过程,按钮352能够携带紧固臂382前移到与标尺399所示的所希望的位置上。
在通过对按钮351和352的操纵而做了合适的止动设置后,可以将手柄和导管组件124与桥接件206连接起来,即将导管组件51和52的远端头穿过桥接件206和鞘32的腔36。继续前移导管组件51和52,使圆柱形延伸部206和它们具有斜的凸轮面301的部件296与柱塞体307的部分307a相啮合,克服弹簧312的力使柱塞体307向侧边移动,以使槽口317与部件296对准,从而允许部件296进一步前移进入桥接件206中,直到离开槽口303,弹簧312沿一方向推动部件307,使其部分307a移动到槽口303中,阻止圆柱形延伸部201进一步内移到内腔288中,直到鞘32已经插入尿道404之后为止,如后文所述。假设膀胱镜271已经通过桥接件206引入到鞘32中,从而其远端头也位于鞘32的远端头处,此时经尿道的针式切除装置31就准备好即可以使用了。
然后医生将一种凝胶润滑剂和一局部麻醉剂如利多可因(Lidocaine)用注射器(未示出)注入阴茎的尿道404中,以便尿道能容纳22法国管(French)号大小的鞘32。在病人尿道较小时,可能要用一系列的扩张器(来示出)。开始时先用最小的扩张器,直到大小接近法国的22号法国管的扩张器引入尿道中为止。此后,医生一手握着阴茎407,另一只手握住装置31的手柄121,将鞘32的远端头引入阴茎的尿道中,并将鞘32逐渐推进,同时通过膀胱镜271的目镜281观察前移的情况。在插入过程中,导管组件51和52的远端头或顶端正好在鞘32的曲面38的近端处,从而尿道壁避免受到导管组件51和52的远端头的损伤。它们上面装有针电极116,针电极116伸出一个短的距离,例如距隔离管86的远端头1-2毫米。换言之,导管组件51和52的顶端或远端头藏在鞘32的远端头下面。有利之处还在于导管组件51和52的无端头不会干扰医生通过膀胱镜的视线,使医生在鞘32前移时能够判定尿道内的生理特征,例如在膀胱之前的前列腺中的精阜和括约肌。和用这些有关男人解剖构造部分的信息,医生能够正确判定他实施切除手术的前列腺中的位置,并转动手柄121,使得要设置的针电极116进入前列腺的适当的叶中。
一旦鞘32处于前列腺406中的合适位置后,例如图29中所示的位置,医生就通过向内推按左侧按钮部分307b,或右侧按钮部分307a,来操纵按钮柱塞体307,以克服弹簧312的力,在所希望的方向上推动柱塞体307,使其中的一个槽口316或317移动与部件296对准,而使圆柱形延伸部206进一步插入内腔288中,从而桥接件206与销326啮合,克服弹簧347的力,将凸轮释放轴321向下向后移动,而操纵凸轮件331和341。导管组件51和52的远端头将设置或定位在离开鞘32远端头的地方,准备将其弯曲。
可以看到,利用两个槽口303和304完成圆柱形延伸部201在桥接件206内腔288中的接合所需要的两个步骤提供了一个安全特征,即它防止了不适时地定位和弯曲导管组件51和52以及针电极116的远端头,而这会在鞘32插入期间损伤尿道壁408。
一旦导管组件51和52的远端头超过鞘32的远端头,导管组件51和52的远端头就可以弯曲,从而它们相对于其纵轴线成一角度(最好为90°)地延伸(如图30所示),而且装在其上的针电极116沿着一个大致垂直于前列腺尿道壁408的方向延伸。这是通过按推按钮218使杆组件217和218前移而完成的。医生在推按按钮218的同时,通过膀胱镜观测导管组件51和52远端头定位的情况。如前所述,由于导管组件51和52的远端头是开有缝口的结构,可以在所希望的90°的角度上将导管组件51和52弯曲在一个小直径上,例如5-10毫米或更小,而仍能超过鞘32的远端头。典型情况下,导管组件51和52弯曲的远端头相互间以一定的角度设置在一个大致相同的平面中,所述角度例如为30~75°,最好约为60°。
可以将滑动控制件131-134作为不同的两组向前推进,其中一组是控制件131和132,另一组是控制件133和134。如前所述,滑动控制件132和133控制针电极116的定位。同时滑动控制件132和133沿向前方向的移动也使沿动控制件131和134同时移动,后者控制隔离管86的定位,以致于对针电极116的定位引起隔离管86同时地前移,而针电极116和包围着该针电极的隔离管86之间的相对定位的结果是使针电极只突出一段很小的距离,例如超过隔离管86的远端头1-2毫米。引起这种同时移动的原因是滑动控制件131引起滑动件41移动,该滑动件41上有一个接头151,它延伸横过滑动件142的后部。因此,在滑动控制件131和132前移期间,导致针电极116穿过被隔离管86紧跟着的尿道壁408(见图34)。尿道壁408被这种方式穿透造成尿道壁撑起(如图34所示),这种撑起或张开随着针116和隔离管86前移进入前列腺406组织中而继续发生。这种前移继续到滑动控制件132和133遇到由可调节的前按钮352提供的适当的止动部分为止。这确定了针电极116穿透到前列腺中的最大深度,如前所述是根据对按钮352的设定量而确定的。这个针止档由图26所示的结构提供,在该结构中,紧固臂382的凸起396上的台肩397被针电极滑动件156的部分157后个表面啮合。在隔离滑动件141和144的前移中,可以很容易地由部分153将滑动件推过紧固件臂183的端头,部分153与凸轮面393啮合,将臂381从路径上推开,并允许部分153支承在台肩392和凸起386上的斜面389之间的空间内。
一旦滑动控制件131-134被前推到它们由按钮确定的最前的位置时,滑动控制件131和134就被缩回,使隔离管86撤回。滑动控制件131和134的这种缩回一直继续到它们达到由前按钮351确定的最后端头为止。隔离滑动件141和144的向后移动由于隔离滑动件141和144的部分153与紧固臂381的台肩392进入啮合而被阻止。当撤回隔离管86后,先前在尿道壁408中出现的撑起现象由于拉回隔离管86而消除,针电极116保留在所要求的已伸出的位置上。但是,如后面描述的那样,隔离套管86只被足够地缩回,使得隔离套管86仍保持穿过尿道壁408,而保护该尿道壁408,如后文件所要描述的那样。在缩回该隔离管86期间,滑动控制件132和133由于与相邻的滑动件131和134磨擦接触而具有与之一起移动的趋势。但是,滑动件组件142和143不会从前面由可调节的前按钮351确定的最前端位置沿向后的方向移动,因为与相关联的肋138可屈服地摩擦接合的制动件162和163所提供的制动作用,使得滑动件156受摩擦力作用而保持住。
这些步骤过程完成以后,病人就可以准备接受供给针电极116上的射频能了。此时针电极116位于前列腺406的恰当的叶中的组织内并且是处在所要求的正确位置上。医生通过操纵脚开关416从控制台和射频发生器413处供给射频能(见图29)。这样,具有所要求的频率和功率水平(由医生预先调节)的射频能就被供到置于前列腺组织406中的针电极116上。
已经发现,为了使针电极116的性能最佳化,最好在两个不是互为谐波频率的不同射频下将射频能供给两个电极116。典型地,射频范围可以为300千赫兹至1光兆赫兹(mkz),尽管需要时也可以用范围为250千赫兹至2兆赫兹的频率。作为例子,曾经发现在将460.8千赫兹的射频能供给一个电极而将482.4千赫兹的射频能供给另一个电极时可以获得所需要的可变的性能。
射频能是在功率水平可以为2~9瓦的范围和针的表面积在0~30平方毫米的范围下供给的。因此,作为例子,一个直径为0.0为7英寸和所暴露的长度为6~22毫米的针电极可以具有3~26平方毫米的表面积。施加射频能的时间可以为2~15分钟,但是典型地,已经发现4~5分钟的长度是恰当的。作为例子,初始功率可以为在4瓦下供给1分钟,然后在供给射频能的第二分钟将功率调节到5瓦,随后在第三、第四和第五分钟内供给射频能时将功率调节到6瓦。
在治过程期间观测到一个缓慢地稳定上升的套管温度即5~8℃(典型地)。如果温度上升小于每分钟5℃,那么射频功率则增加大约1瓦。相反,如果温度上升大于8℃/分,或者阻抗突增,那么供给的射频功率则减小大约1瓦。
设置在针电极116上的可伸缩套管86用于保护尿道壁408免受射频能的损伤。设置在隔离套管组件81和82末端处的热电偶监测前列腺尿道壁408的温度。此外,该热电偶还监测靠近由针电极产生的损伤处的前列腺温度。这些损伤是在从针电极116暴露在前列腺组织中的外表面、经该组织进入病人射体内到达接地电极411,然后回到射频功率源413所完成的射频能的电回路中传导射频能时形成的。在每个电极116的周围形成一个损伤429,同时由隔离管86保护尿道壁408免受所产生的热损害。
通过从针电极施加的射频能而在针电极116周转形成损伤的情况是可以解释的,因为人体组织主要是电解质、脂肪和钙,并且在不同的波长下与电磁辐射产生不同的相互作用。由于组织中相当均匀地渗透着一种具有定常浓度电解质的含盐溶液,因此组织起着一个弱导体的作用。如果施加在人体组织上的电场的波长相对人体尺寸是长波(在500千赫兹时它为600米),那么相互作用的结果将主要是在电热频率下移动离子和水分子时的损失。电流越高,分子活动就越激烈,温度在给定时间里就上升越高。如果电场强加在两个相同尺寸的电极之间,那么电极的每单位面积的电流量(定义为电流密度)在两个电极处是相似的。如果一个电极非常小但总的电流量仍量流过,那么电流密度就会非常高,相应地,小电极处的温度就较高,例如在针电极处。如果组织被加热到干燥点,则不再存在导电性能,组织变成一个不导电的介质并且电流以及加热会议上。这表现在组织的电阻大大增加。利用诸如本发明的装置31这样的装置施加射频能而产生的代表性结果在于产生平均尺寸为12×7毫米的局部损伤,如果需要,也可以形成较大的损伤,表现为平均尺寸为30×15毫米的广泛凝结和坏死,施加的功率为4~15瓦,时间约为3分钟。
图34中示出了一个具有代表性的温度梯度图,其中等温线431代表着在用装置31产生一个损伤的期间认为要在前列腺组织406中碰到的不同温度。由图34可以看到,等温线形成了大体上为卵形的包络线,它们围绕着针电极116的前端沿朝着返回电极411的方向延伸,开始的温度是100℃,位于电极116的最近处。等温线431表明,前列腺组织中的温度是通过温度为90℃,80℃和60℃的等温梯度线逐渐地下降的,这些温度范围大体上代表了为了形成一个损伤而前列腺组织中产生的坏死的总体积。典型地,从针电极116的表面到所产生的损伤的外表面的平均梯度大约为每毫米50℃,此时最大平均温度大约为100℃。如本领域的专业人员所公知的那样,在低于约55℃的温度下,前列腺组织没有受到有害的破坏。
观察图34中的等温梯度线431,可以看到,通过仔细地控制前列腺组织中所达到的温度,有可能相当精确地控制所产生的损伤的大小。在本例中,这是由放置在隔离套组件81和82远端头处的热电偶96来做的。应当认识到,如果能进行所要求的附加的温度测量,例如利用设置在紧靠近前列腺的一个直肠探测器,则将保证不会产生不当的加热。应当意识到射频发生器413配置有控制器,它们将在热电偶探测到温度过分高时自动地切断射频功率源。
已经发现,针上暴露的表面大小和施加的能量多少以及施加能量的时间之间存在直接的关系,因此,作为举例,施加大约2-3瓦的功率可以产生2-4毫米的小损伤,基本上与针电极暴露的毫米长度无关。但是,当增大施加的功率时,例如3-8瓦且时间为1分钟,可以在针暴露长度为5-10毫米下获得宽度为4~7毫米的中等尺度的损伤。当施加3-12瓦范围的射频功率且持续时间2~4分钟时,而电极针暴露的长度为10毫米或更长时,可以获得更大的但仍为中等尺寸的损伤,其范围为4~8毫米。范围为8-10毫米宽的大损伤可以通过施加5~15瓦的功率的射频能,时间持续3~5分钟并且在针电极暴露15毫米或更长情况下获得。非常大的损伤,例如宽度大于10毫米的损伤,可以通过施加5~15瓦的功率,时间持续4分钟以上,在针电极暴露长度大于15毫米下获得。
因此,为了利用前述方法获取更加特殊的结果,将两个成60°的锐角设置的针电极116引入到前列腺的其中的一个横叶中。在将4~15瓦的射频能施加了3分钟后,靠近损伤处的温度为大约40~50℃,而损伤的中心温度大约为80~100℃。尿道壁408处的温度平均值为37~42℃,远小于可能产生尿道壁408热损害的温度值55℃。通过在预定的时间内有控制地施加射频能,应用本方法可以保护尿道壁,也可以维持包围前列腺的包囊的完整。换言之,损伤完全产生于横叶内而与尿道壁和前列腺包囊相间隔开。
当通过两个针电极116形成两个损伤而治疗了前列腺406横叶中的一个横叶后,医生在使用膀胱镜271的同时将控制针电极116定位的滑动控制件131和134往回拉,这种向回拉动滑动控制件132和133使滑动件组件142和143向后移动,它克服制动件162和163的制动作用使滑动件组件142和143与接头151啮合,也造成滑动控制件131和134的回缩。
通过从紧固臂381上释放的隔离滑动件141和144可以使滑动件组件142和143带着针电极116和隔离滑动件一起向后移动。在从紧固臂381上释放隔离滑动件141和144时,要将针电极滑动件组件142和143上的隔离止动释放臂169与凸起386上的凸面388相啮合,将紧固臂381向外朝着壳126的侧壁方向顶推,而释放开隔离滑动件141和144上的部分153(见图26),之后就允许滑动件组件142和143继续后移,并带着滑动件141和144移动,直到达到一个最后的位置。此时向回拉动杆组216和217可以拉直导管组51和52。
假设针电极116在一个平面例如一个正好在膀胱颈下面的一个平面中被引入到前列腺406的一个横叶中,则可以将鞘32与针电极116和隔离管86一起收回,使它们收回到尿道壁408的后面。然后使鞘转动例如120℃,使得电极116的远端头保持在相同平面中但相对着前列腺的另一个横叶。一旦完成这种重新定位后,可以操纵杆组件216和217,使导管组件51和52的远端头按前述方式再次弯曲。然后按前述方式启动滑动控制件131-134,使针电极116和隔离套管86穿透尿道壁408并推进到另一个横叶中的前列腺组织中。假设在这另一个横叶中采用了相同的预先设置,针电极116延伸到另一个横叶组织中所要求的位置,并且通过拉回隔离管86使针电极暴露合适的长度。隔离管86使针电极暴露出来,但它设置得仍然超过尿道壁408一段距离,以便在手术过程中保护尿道壁408。在此之后,以合适的功率水平和时间再次施加射频能,以便在另一个横叶中产生两个损伤。完全这一过程后,可以按前述方式撤回针电极116和隔离管86,使之缩回到尿道壁408后面。之后,如果要在前列腺406中的不同平面内产生附加的损伤,医生握住手柄121可以对鞘32的远端头重新定位到一个下平面,对下一个平面中的两个横叶重复相同的手术过程。
已经发现,要在其中产生损伤的治疗平面或平面的数目取决于要治疗的前列腺的大小。因此,当精阜至膀胱颈之间的距离小于3厘米时,则通常只需要一个单一的治疗平面,该平面位于精阜和膀胱颈之间的中点。当精阜和膀胱颈之间的距离超过3~4厘米,一般要用两个治疗平面,其中近平面大约距精阜2厘米,另一个治疗平面大约距精阜1厘米。当精阜至膀胱颈的距离大于4厘米时,典型地,要在距精阜前面1,2和3厘米处设定三个横向治疗平面。
当前列腺组织406中已经形成的所要求的数目的损伤后,可以向后移动滑动控制件131-134,之后可以向后拉动控制杆组件216和217的钮218,以消除导管组件51和52远端头中的90°弯曲部分。按动按钮307b或307c使其中的一个槽口316或317与横条296对准,使得手柄和导管组件124能部分地缩回,从而使导管组件51和52的远端头缩回到鞘中,即收缩到鞘32的远端头之内。一旦这种操作完成后,就可以将整个经尿道的针式切除装置31从阴茎407的尿道404中取出,由此完成TUNA手术过程。
此时,医生可以选择一种抗菌素注入尿道404中,以有助于防止发生感染。手术过程结束后,典型地,病人可以休息片刻,然后离开手术室回家去。
在TUNA手术过程中,针电极总是定位在至少距离前列腺的包囊6毫米之外,以保证TUNA手术过程不会损坏包囊的完整性。类似地,隔离管86定位得超过尿道壁一个距离,其范围在4~6毫米,也是为了保证TUNA手术过程不会损坏包囊的完整性。穿透尿道壁的小孔在TUNA手术过程后很容易愈合。
典型地,一个已经接受了TUNA手术而在此之前有排尿困难的病人在手术之后会感觉到某种平滑肌组织松驰,其结果是降低了尿道的收缩力。这样,在一个很短的时期内,即从几个小时至24~48小时的范围内,病人感受到尿流有一定程度的改善。在一个较长的时期上已经发现病人不需要实施插管导尿,而且病人在一个相当短的时期内即1-4天内就感受到尿流的改善。接受TUNA手术的病人的长时期的结果已经表明,在6~12周后,病人已经大大地改善了尿流,并且在TUNA手术后的6~9月后就经历了与年青男子的尿流相当的尿流。
关于本发明的TUNA手术,已经发现,为了在前列腺组织中形成不可回复的组织损伤,以提供前述的持久性临床好处,如果该温度作用了一段较长的时间的话那么45℃以上的温度会造成一些细胞组织的坏死,但是,为了实现与本TUNA手术相关的热切除,最好用60℃和更高的温度,以便将施加射频能的时间缩短到合理的时间范围。因此,即使在前列腺组织中产生多个损伤,利用TUNA装置31也可以典型地在15~25分钟内完成整个手术过程。在针电极116周围的局部处可以很容易达到范围为80~100℃的大大超过60℃的高温,该高温只需要施加3~5分钟。因此,尽管在隔离管86顶端处测量的温度可以高达75℃,但在针电极后端处的温度典型地要高出30~45℃。如前所述的主要坏死性损伤是可以获得的,该损伤展现出广泛的凝结坏死,其在TUNA手术后大约30天这种坏死的尺寸宏观上肉眼上)看为15×8毫米,微观上(显微镜下)看为30×15毫米。
电磁波在前列腺组织中的穿透度取决于它们的频率,频率越低,穿透度越高。与TUNA装置31相关而采用的射频能应用的是在490千赫兹附近的射频,它提供了比300~3000兆赫兹的微波更深的穿透度和更均匀的温度分布。TUNA装置能够应用很低的功率水平亦即5~10瓦产生具有精确确定的边界的损伤。这是因为从针列损伤的外周面之间具有很徒的温度梯度。这是与经尿道的微波疗法进行比较,这种疗法在靠近尿道的损伤区中的几个毫米上产生5~15℃的温度梯度,在包囊附近为每毫米1-2℃。另一方面,TUNA装置利用在490千赫兹附近的射频能,从而能够提供更陡的梯度,在针电极116的近端头(在尿道壁的附近区域)为58℃/毫米,在针顶端附近为30℃/毫米(在前列腺囊附近区域)。
由前面所述的内容可以看到,应用本发明的TUNA装置的TUNA手术过程能够非常有选择地控制前列腺中的局部切除区域。它维持了前列腺包囊和尿道壁的完整性。在手术过程中发生在尿道壁上的小孔会迅速地愈合,出血程度被降至最低,而且大大降低了受感染的潜在性。虽然在任何一个前列腺中可以需要做多到8-12个损伤,手术仍能在20~40分钟内完成。这种手术能够用不高的费用在门诊部做,它只需要做一次局部麻醉。因此,可以看到,TUNA手术是对在此之前用于治疗良性前列腺肥大的常规手术(或治疗方法)的一种可行的费用不高的替代手术。
TUNA装置的另一个实施例(可以称为TUNA IV)示于图35-38中,并记为装置451。该装置包含一个手柄和导管组件452,它与前面在TUNA III中描述的手柄和导管组件124非常相似。组件452可以与一个桥接件456相接合,该桥接件456也是前面TUNA III中所述的那种类型的桥接件。一个鞘461按照与鞘32相同的方式连接到桥接件456上。但鞘461是一个较小尺寸的,例如是16号法国管(French),而不是鞘32所采用的22号法国管,使之能够进行进入阴茎的尿道中,而不需要象鞘32所要求的对尿道进行额外的大扩展。鞘461有一个腔462,其中设置一个直径小于管272的光纤管466,它与导管组件51和52相连,提供一个大体上为三角形的外廓,如图37中所示。光纤管466有一个0.05英寸外径的不锈钢外管468,一个聚酰亚胺做的内管467设置在管468中并包住一个内空有圆柱形光纤维束721,该束721包围一个探视纤维束472。含有一个带内台阶的圆柱形透镜槽477的透镜组件476在每一端装有一个平凸透镜478。透镜槽477的一端用一个由一种紫外线凝固的粘胶剂形成的接头481与探视纤维束472的远端头相接。透镜槽477支撑在光纤维束471的远端头内,光纤维束471由内外聚酰亚胺鞘483和484支持,后者用粘胶剂固定在一个接头486上,以安装管486和聚酰亚胺鞘469。透镜槽和它的平凸透镜478一起提供了一个较宽的视野。
鞘461除了用不锈钢制作外,也可以用塑料做,但典型地说,薄壁不锈钢管更适合于获得所要求的刚度,以便于将TUNA IV装置引入尿道中,而在将鞘引入前列腺中的同时使尿道提起和伸直。
光纤维管466构成膀胱镜491的一部分,后者有一个目镜492。膀胱镜491穿过一个安装在桥接件456近端头上的一个三接头496。该三接头496有第一和第二口497和498,其中第一口497用于引入光,而第二口498用于引入一种液体。
一个调节机构501配置在膀胱镜491上,以便在桥接件456的纵向上调节膀胱镜,从而平凸镜478能够相对于鞘461的远端头恰当地定位。这种调节机构包含一个连接在三接头本体504的一个延伸部503上的螺纹帽502。一个光接头506可滑动地安装在本体中的一个凹腔507中,并且有一个位于帽502下面的径向延伸的凸缘508。光接头506延伸通过帽502中的一个孔509,并有一个螺纹部分506a,其上装有一个螺母511,使接头506保持在帽502。光纤管466与接头506相连,并与接头506一起移动。接头506装有探视纤维472和光传输纤维471。可以看到,当在本体504的纵向调节有帽螺钉502时,它将带动光纤管466,从而装有平凸镜478的远端头可以相对于461的远端头精确地调节,以使装置451的探视能力达到最佳化。
TUNAIV装置451可以按照TUNAIII装置31在前述实施TUNA手术中的相同方式来使用。TUNAIV装置的主要优点是它能够用于具有较小尿道的男性病人,或者另一种情况,即可以用于不需广泛扩张病人尿道壁的男性病人。它也配置有调节机构,使光线视觉效果最佳化。
Claims (18)
1.一种经由尿道的针式切除装置,该装置利用一个射频电源的射频能来治疗男性前列腺,所述男性有一个带颈口的膀胱,一个前列腺和一个阴茎,其中有一个由尿道壁形成的尿道,该尿道从膀胱颈口开始延伸,沿着前列腺的一条纵轴穿过该前列腺和阴茎,前列腺在膀胱颈口附近有包围着尿道壁的前列腺组织,所述装置的特征在于:包括一个鞘,该鞘有一个近端头和一个远端头以及一个从近端头延伸到远端头的内腔;一个导管组件,该导管组件可滑动地安装在鞘的内腔中并有一个近端头和一个远端头和一个从近端头延伸到远端头的内腔以及一个纵轴;一个针电极,该针电极被可滑动地安装在导管组件的内腔中等有一个近端头和一个远端头;一个隔离套管,该隔离套管围住针电极设置并有一个远端头,该远端头所处的位置能使针电极的远端头露出来;一个手柄,该手柄能由人手握住,在手柄上安装鞘的近端头的部件;装在手柄上并与导管组件相连的部件,该部件用于从导管组件的远端头位于鞘的远端头之内的一个缩回位置和导管组件的远端头位于远端鞘的一个伸出位置移动该导管组件的远端头,装在手柄上并与导管组件相连的部件,该部件用于使导管组件的远端头相对于纵轴线弯曲成一定的角度,由此使导管组件中的内腔能够定向而指向尿道壁;连接到针电极上的部件,该部件能够连到射频功率源上以将射频能供到针电极上;装在手柄上并连接到针电极和隔离套管上的部件,该部件用于相对于导管使针电极前移和缩回,由此当鞘定位到尿道中并且其远端头位于前列腺附近时,可以将针电极推进穿透尿道壁进入前列腺组织中由此可以将射频能施加到围绕针电极的前列腺组织上而在前列腺中造成一个损伤。
2.按权利要求1的装置,其中,装在手柄上并与针电极和隔离套管相连的部件包含使隔离套管和针电极之间产生相对滑动的部件。
3.按权利要求1的装置,其中包括装在手柄上的部件,一起防止导管组件的远端头在它延伸到鞘的远端头之外以前受到弯曲。
4.按权利要求1的装置,其中,所述装在手柄上并连接到针电极和隔离套上的部件包含可滑动地安装在手柄上的第一和第二滑动件,将针电极连接到第一滑动件上的部件,将隔离套连接到第二滑动件上的部件,所述第一和第二滑动件能够在前端位置和后端位置之间移动。
5.按权利要求4的装置,其中还包括制动部件,它连接到第一滑动件上并与手柄啮合,用于在第二滑动件朝着一个前端位置缩回到防止第一滑动件移动。
6.按权利要求4的装置,其中还包含可调节的止动部件,它装有手柄上,可以与第一滑动件啮合,用于预先设定针电极的最大的定位距离,还包含另外的可调节的止档部件,可以与第二滑动件相啮合,用于预先设定隔离套管相对于针电极所缩回的距离。
7.按权利要求1的装置,其中,将鞘的近端头安装在手柄上的部件包含一个桥接件,该桥接件固定到鞘的近端头上和手柄上,包含将手柄连到桥接件上的部件,该部件包含能够占据两个不同位置的相互配合的部件,其中在第一位置时,导管组件的远端头被置于鞘的远端头之内,当在第二位置时,导管组件的远端头被置于鞘的远端头之外的位置上。
8.按权利要求7的装置,其中所述相互配合的部件包含一个装在手柄上的圆柱形延伸部分,其中桥接件中有一个内腔,该内腔可以容纳此圆柱形延伸部分,和装有桥接件上和圆柱形延伸部分上的配合带齿部件,能够将所述内腔中的圆柱形延伸部分锁住在所述的两个不同的位置上。
9.按权利要求8的装置,其中,相配合的带齿部件包含一个能够让人手操纵该带齿部件的部件,以使相互配合的部件从第一位置移动到第二位置。
10.按权利要求7的装置,其中还包含装在手柄上的安全部件,用于防止针电极和隔离套管移动,直到相互配合的部件占据了第二位置为止。
11.按权利要求10的装置,其中,所述安全部件包含一个装在手柄上的释放部件,能够在相互配合的部件占据第二位置时操纵该释放部件,以使针电极和隔离套管能够移动。
12.按权利要求11的装置,其中,防止针电极和隔离套管移动的部件包含与释放部件从运行上相连的凸轮件,用于防止滑动件移动。
13.按权利要求1的装置,其中还包含一个另外的导管组件,它可滑动地安装在鞘的内腔中,并且可以按照第一导管线组件相同的方式移动,用于在与第一导管组件产生的前列腺损伤的不同位置上产生前列腺中的另一个损伤。
14.按权利要求16的装置,其中,用于向针电极供给射频能的部件包含将射频能供给另外的导管组件的针电极的部件,所述施加到第一针电极和另外的针电极上的射频能具有互不谐振的不同频率。
15.一种治疗男性前列腺良性肥大的方法,所述男性有一个带底部(或颈)的膀胱,一个前列腺和一个阴茎,以及一条由尿道壁形成的尿道,该尿道沿着一条纵轴穿过前列腺和阴茎延伸,前列腺有包围着尿道壁的前列腺组织,本方法应用具有一个远端头的针电极治疗前列腺,其特征在于:包括以下步骤:将针电极引入尿道,沿所述纵轴线推进针电极,直到针电极处于前列腺附近,然后将针电极的远端头沿着一个与尿道轴线成相当大角度方向弯曲,使之对着尿道壁,推进针电极的远端头使之穿透尿道壁并伸入到前列腺组织中,将射频能供到电极上使得一股电流以足够的功率水平和足够的时间经前列腺组织的导电性而流过,从而使针电极附近以及一个限定的区域中的前列腺组织的温度升高,以便在前列腺组织中造成一个损伤,损伤所处的位置与尿道壁和前列腺囊间隔一定距离的。
16.按权利要求15的方法,其中还包含以下步骤:从前列腺组织中和尿道壁上撤回针电极,重新将针电极定向进入尿道中的一个不同位置,然后推进针电极使之穿过尿道壁进到前列腺中的一个不同位置,将射频能供到针电极上,使电流经传导流过前列腺组织从而以相同的方式在前列腺组织中形成另一个损伤。
17.按权利要求15的方法,其中还包含以下步骤:将另一个针电极按相同的方式引入前列腺组织中并供给两个不同频率的射频能,这两个频率不是谐波相关的频率,以便在前列腺组织中同时造成两个损伤。
18.按权利要求15的方法,其中针电极包封在一个隔离套管中,隔离套管和针电极能够相互相对地移动,所述方法还包含以下步骤:将隔离套管和针电极一起推入前列腺组织中,然后收缩回隔离套管而将针电极保持在预定的位置上,以暴露出针电极,但使隔离套管延伸超出尿道壁一足够的距离,从而在将射频能施加到针电极期间保护尿道壁。
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FR2716365A1 (fr) | 1995-08-25 |
DE4423216A1 (de) | 1995-08-03 |
CA2155217A1 (en) | 1994-08-18 |
FR2716365B1 (fr) | 1997-05-30 |
WO1994017856A1 (en) | 1994-08-18 |
US5807309A (en) | 1998-09-15 |
AU6133194A (en) | 1994-08-29 |
AU718834B2 (en) | 2000-04-20 |
DE9410653U1 (de) | 1994-10-27 |
US6241702B1 (en) | 2001-06-05 |
DE4423216B4 (de) | 2006-11-02 |
IL108532A0 (en) | 1994-08-26 |
TW286271B (zh) | 1996-09-21 |
EP0631514A1 (en) | 1995-01-04 |
AU6189698A (en) | 1998-07-09 |
US5549644A (en) | 1996-08-27 |
US5762626A (en) | 1998-06-09 |
AU685086B2 (en) | 1998-01-15 |
JPH08506259A (ja) | 1996-07-09 |
EP0631514A4 (en) | 1995-04-26 |
IL108532A (en) | 1997-07-13 |
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