CN1173118A - 带膀胱镜的经尿道针释放器械及治疗尿失禁的方法 - Google Patents

带膀胱镜的经尿道针释放器械及治疗尿失禁的方法 Download PDF

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CN1173118A
CN1173118A CN95197452A CN95197452A CN1173118A CN 1173118 A CN1173118 A CN 1173118A CN 95197452 A CN95197452 A CN 95197452A CN 95197452 A CN95197452 A CN 95197452A CN 1173118 A CN1173118 A CN 1173118A
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斯图尔特·D·爱德华兹
罗纳德·G·拉克斯
休·R·夏基
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Medtronic Vidamed Inc
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1475—Electrodes retractable in or deployable from a housing
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
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Abstract

一医疗器械(20),其包括一细长探头部件(22),该部件的尺寸大小适于进入女性尿道内,其远端(22b)置于尿道周围组织的靶区附近,而近端位于尿道之外。该细长探头部件(22)具有一自近端(22a)向远端(22b)延伸的通道(31)。至少一个空心探针(41)置于通道(31)内,其具有第一端和第二端(41a,41b)以及沿其长度方向自第一端(41a)伸向位于该探针(41)的第二端(41b)上的至少一个开口(43)的液流通路(42)。一控制柄(61)固定于细长探头部件(22)的近端(22a),以使空心探针(41)在通道(31)内移动。导向通路(58)可使探针(41)沿曲线路径相对纵轴(27)以某一角度伸展。供药装置(96)装在细长探头部件(22)的近端(22a)上且和探针(41)上的液流通路(42)连通,以将药剂导入液流通路(42)。并提供一种使用器械(20)的方法。

Description

带膀胱镜的经尿道探针释放 器械及治疗尿失禁的方法
概括地说，本发明涉及一种治疗尿失禁的经尿道医疗器械，特别涉及一种具有用于穿入女性尿道的探针的经尿道医疗器械。
患尿失禁的人有许多，这其中包括大量的老年妇女和护理站病人。妇女生产后或男性前列腺术后，常常会出现压力性尿失禁，它是指咳嗽、打喷嚏、锻炼或活动时因腹压增加而造成的尿液突然渗露。目前，虽然已有一些治疗尿失禁的办法，但在已有的病例中，尚未发现哪一种办法令人十分满意。因此，有必要提供一种治疗尿失禁的器械和方法，以克服存在的问题。
总的来说，本发明的目的是提供一种治疗尿失禁的器械和方法。
本发明的另一目的在于提供一种治疗尿失禁的器械和方法，其中，将药剂导入尿道周围的组织中以强化对括约肌的支持。
本发明的另一目的在于提供一种治疗尿失禁的器械和方法，其中，将药剂导入组织间隙中。
本发明的另一目的在于提供一种治疗尿失禁的器械和方法，其中，将药剂导入采用射频切除方法形成的组织间隙中。
本发明的另一目的在于提供一种治疗尿失禁的器械和方法，其中，在将药剂导入组织的过程中将药剂加热，以防止药剂未导入时发生凝固。
本发明的另一目的在于提供一种治疗尿失禁的器械和方法，其中，在将药剂导入组织的靶区后将其加热，以加速药剂在靶区内的凝固。
本发明的另一目的在于提供一种治疗尿失禁的器械和方法，其中，利用射频能量将导入靶区内的药剂进行加热。
本发明的另一目的在于提供一种治疗尿失禁的器械和方法，其中，将药剂同时导入尿道周围组织中的多个靶区。
通过下面进行的描述，可以看出本发明的其它目的和特征，这里，参照附图详细地叙述了几个优选实施例。
图1为本发明的经尿道探针释放器械的一个实施例的透视图；
图2为沿图1中的2-2线所取的图1的经尿道探针释放器械的剖视图；
图3为沿图2中的3-3线所取的图1的经尿道探针释放器械的剖视图；
图4为沿图3中的4-4线所取的图1的经尿道探针释放器械的剖视图；
图5为沿图2中的5-5线所取的图1的经尿道探针释放器械的放大后的等角投影图，其局部已被剖开；
图6示出了图1所示的经尿道探针释放器械的一部分置入女性尿道时的情况；
图7为本发明的经尿道探针释放器械的另一个实施例的透视图；
图8为沿图7的8-8线所取的图7的经尿道探针释放器械的剖视图；
图9为沿图8的9-9线所取的图7的经尿道探针释放器械的剖视图；
图10示出了图7所示的经尿道探针释放器械的一部分置入女性尿道时的情况。
本发明的经尿道探针释放医疗器械20用于治疗尿失禁，尤其用于治疗女性的压力性尿失禁。器械20用于将诸如混合物21之类的药剂或药物注射到位于尿道括约肌正上方或正下方的尿道周围的组织中。图1-5所示的释放器械20包括一个最大可为26French的导管状细长管式探头22，探头的尺寸介于4至12cm之间。如图2或图3所示，主体或探头22具有近端22a和远端22b，其侧壁26的横截面大致呈圆形。纵轴27过近端22a和远端22b，侧壁26用于形成沿探头22纵向伸展的通道31。通道31于远端22b由一钝头33封闭。在探头22的远端22b，至少有一个贯穿侧壁26的通孔36，在图1中，有四个这样的通孔沿周向间隔分布。
探头22上装有至少一个空心射频探针或电极41，在图1-3中示出了四个这样的探针，探针大致位于和纵轴27大致垂直的一个平面内，它相对于探头可滑动地安装。电极41由不锈钢之类的导电材料制成，其上有一通路42，见图4，通路沿纵向在探针的第一端，即近端41a和第二端，即远端41b之间伸展。电极41的横截面基本为圆形，其内截面的面积大小取决于混合物21的粘度等因素。更具体地说，每个电极41的外径为0.3至1.2mm，内径为0.2至1.0mm，最好为0.5mm左右。在每个电极41的远端部分41b至少有一个侧口43，在附图中示出了沿纵向间隔分布的几个侧口43。侧口43贯通每个电极的侧壁47以和它的液流通路42连通。如图4所示，每个电极41有一个封闭的尖端51。
由诸如塑料之类的合适的绝缘材料制成的护套或套管52和每一电极41同轴置放以相对于电极沿其长度方向滑动。绝缘护套52有适当的壁厚，如约为0.05mm，它具有第一端即近端52a和第二端即远端52b。
探头22中具有一导向装置，它为导向管56，用于在通道31内沿曲线路径对电极41和绝缘护套52导向，从而使自由端即远端41b和52b沿期望的方向自探头侧壁26向外伸出。导向管56或内插管56由不锈钢之类的合适的材料制成，它具有第一端部即近端部56a和第二端部即远端部56b。每一导向管在探头22内依一曲线沿伸，曲线的两端部之间约成90°角。近端部56a在探头内大致沿纵向伸展，并用诸如粘合剂57之类的适当的方法将其封住或固定住。采用诸如粘合剂(未示出)之类的任何合适的方法使远端部56b连接或固定在侧壁26的开口36内，使之和侧壁26的外表面大致平齐(见图2和图3)。每个导向管56上具有一自近端部56a向远端部56b沿长度方向伸展的导路或管腔58，用于将绝缘套管52滑动地插入。电极41可滑动地装在该绝缘套管内。这样，导向管56容纳于器械20之中，它可使电极41沿曲线路径和纵轴27成等一角度伸出。
本发明的导向装置也可以是固定在探头22内部或和探头形成一个整体的整体模制元件(未示出)，它具有和管腔58类似的管腔。
控制柄61固定于探头22的近端22a上。更具体地说，控制柄61和探头22形成一整体，它具有一端壁62。
操作装置63和控制柄61相连，它用于使电极41和绝缘套管52在管腔58内动作。操作装置63包括一由诸如黄铜之类合适的材料制成的汇流盘66，它在通道31内和纵轴27垂直置放，它和与电极41相对的一端或近端41a焊接在一起或以其它适当的方法连在一起。一大致呈锥形的歧管67可由诸如塑料或钢之类的任何适当的材料制成，用粘合剂或其它适当的方法(未示出)将歧管固定于汇流盘66的近侧端。由不锈钢或其它任何合适的导电材料制成的细长管子71和歧管67的收缩近端的中心部以压配合连接或以其它适当的方式连接，且沿纵轴27延伸通过端壁62的中心部的开口。管子71的近端和第一把手或称探针展开把手72以压配合连接，也可以其它适当的方式连接，并沿图2所示的方向可纵向移动，其中探针展开把手可由任何适当的材料制成，如塑料。
操作装置63还包括一盘形套衬或活塞81，它横置于通道31中且位于导向管56和歧管67之间。活塞81由塑料或其它合适的材料制成，其上有排列整齐的四个纵向通孔，以便使电极41的近端41a可以穿过。绝缘套管52的近端52a和活塞81的孔82压配合连接，也可以其它方式固定。具有近端部83a和远端部83b的由不锈钢或其它合适材料制成的推/拉杆83从端壁62的开孔86和歧管67的开孔87中穿过。推/拉杆的远端部83b以压配合方式或以其它适当的方式固定在活塞82上，其近端部83a以同样的方式固定在第二把手或称绝缘把手91上，第二把手由塑料或其它合适的材料制成，它位于端壁62和探针把手72之间。绝缘把手91的中心部开有通孔92，以便使该把手按图2所示方向沿穿过其通孔92的管子71轴向滑动。
供药装置装在探头22的近端22a，用于将混合物21导入电极41的液流通路42，供药装置上有一配件96连于管子71的近端。如图5所示，管子71的中心有一管腔93，以便将混合物21送入歧管67上的分流通路97中，见图2。分流通路97和汇流盘66上的几个通孔是连通的，且和电极41的液流通路42也是通的。
一直列式加热装置106和管子71同轴安装在一起，它装在器械20内，用于对流经管子71的混合物进行加热。加热装置106包括一个电阻覆层107，由氧化铁之类的适当材料组成，它将一部分管子71沿周向包绕起来，其外套108由不锈钢或其它合适的导体材料组成，用它把覆层107裹住。外套108被绝热层或绝缘层(未示出)包住，以防止有害电流和传递的热量影响组织。电引线111和112分别和管子71和管形外套108相连，包含引线111和112的导线116伸出侧壁26，导线的一端装有一插头117，以便向加热装置106提供电能。器械20具有第一热传感装置，它至少包括一个装在电极41的液流通路42内的第一热电偶118，当液流自侧口43(见图4)流出时，用它可以监测混合物21的温度。引线119自热电偶伸向探头22的近端22a，图4中示出了引线119的一部分。
也可以使用电导线(未示)对混合物21进行加热。使电导线纵向沿伸并使其固定在管子71的中心腔93内。电导线通电时，它即可向流经管腔93的混合物提供热量。
可用其它引线或导线121向电极41提供射频能、微波能或电能，导线穿过侧壁26和歧管67而和汇流盘66电连接。导线121的末端装有插头122，用于和适当的发生器或电源连接(未示出)。在器械20装有一第二温度传感装置，它至少包括一个装在绝缘套筒52的顶端部的第二热电偶123，用于监测电极41处人体组织的温度。一引线(未示出)自第二热电偶伸向探头22的近端22a。
器械20还包括一个膀胱镜126，其上有光纤元件或杆式光学元件127在通道31中沿纵向穿过歧管67，分流盘66和活塞81。探头22的钝头一端33上形成有开孔131，光学元件127的远端伸入此开孔。在膀胱镜126的光学元件127的近端装有一配件132，配件132上装有一目镜133。
尽管图中所示的器械20上所安装的绝缘护套或套管52可沿电极41的长度方向滑动，但在器械20的另一个实施例中，套管52可固定地安装在每一电极41上而不滑动。以后将对此实施例进行描述。在本发明的这一实施例中，可用粘合剂等任何合适的方法将活塞81固定在探头22的内侧，图中未示。推/拉杆83和绝缘把手91去掉。
下面简要地描述对患有压力性尿失禁的女性患者进行治疗时经尿道探针释放器械20的操作和使用过程。图6示出了接受治疗的女性患者141的局部，给出了重点部位的解剖结构。从图中可看出，解剖结构中包括膀胱142，它具有一膀胱底或膀胱颈143，用于将尿排入尿道146。尿道146由内皮层或尿道壁147形成，尿道壁延伸到外尿道口148即体外。尿道壁147周围的组织151有脂肪组织152，尿道括约肌153和脂肪组织156。
假定在病人的预治疗方案中确定病人要进行下面的经尿道治疗，将病人送至医院门诊部或手术室。术前，使病人处于背侧膀胱切石手术时的位置，并在其身上盖上布。若要通过电极41施加射频能量或其它电能，可在患者的臀部装一个中性或接地电极(未示出)，以使其牢固地固定并和患者的皮肤有良好的电接触性能。导线116的插头117和导线121的插头122连至控制台电源和射频发生器或其它发生器上(未示出)。使用器械20前，将把手72和91向后拉，使电极41和绝缘套管52完全缩入导向管56中。
然后，医生用注射器(未示出)将润滑脂和局部麻醉剂如Lidocaine一起注入尿道146，以便使尿道中放入探头22。然后将探头22的远端22b导入尿道146中并逐渐向前推，同时借助膀胱镜126的目镜133观察探头所处的位置。根据由膀胱镜126对女性尿道解剖结构的观察，医生可正确地判定尿道中需要实施治疗的部位。例如，在图6中，探头的开口36处于脂肪组织156中的靶区157附近。可以看出，探头22的直径使其能够进入尿道146中，探头的长度使其远端22b位于组织151的靶区157附近而使其近端22a位于尿道146之外。
一旦探头22的远端22b在尿道146内适当地定位，例如图6所示的那样，相对于控制柄61将探针把手72和绝缘把手91向前推，从而使开有孔的电极41和绝缘套管52伸出导向管56并伸出侧壁26上的开孔36之外。推动把手72和91使电极41，紧接着是绝缘套管52大致沿径向自纵轴27辐射伸展并穿过尿道壁147。然后沿纵向相对于控制柄61调整把手72和91，直至电极的尖端51自侧壁26伸出某一预定的长度，从而至少使具有侧口43的电极远端41b部分向前伸出绝缘套管52的端部。由于套管52和电极41可沿纵方向作相对运动，最好是先将绝缘套管52的远端52b向前移动，然后再相对于电极41回缩，从而使尿道壁的创伤尽量减小。
可以在管子71的近端和杆83的近端部83a上刻上适当的标记(未示出)，以便根据其相对于控制柄61的端壁62的位置来相应表示电极41和绝缘套管52相对于侧壁26的位置。可以看出，电极41可相对于套管52向内和向外移动，绝缘套管可相对于侧壁26向内和向外作相对移动，从而使电极41和绝缘套管52定位于组织151的靶区157。
当电极41和绝缘套管52如此进入组织151内时，它们的远端41b和52b大致在一组平面内沿径向伸出探头52之外。电极和绝缘套管绕纵轴27沿周向间隔分布，且和纵轴约成90°角。
然后，可通过导线121向电极41提供射频能量，以灼除电极远端41b周围的组织151，从而使组织151形成空腔。射频能量由控制台和射频发生器(未示出)提供。典型地，射频频率为300KHz至26MHz。传送射频能量时，其能级为2W至80W，作用时间为5秒至5分钟，在某些治疗过程中可以延长。间隙158的大小取决于药剂施加部位的数目、尿道内所需的收缩量等因素。在进行灼除时，已经进入尿道壁147的绝缘套管52可保护尿道壁使之不会被射频灼除。第二热电偶或热电偶123通过测量灼除电极周围组织151的温度可对电极41输出的能量进行监控。
用上面所述的方法形成组织间隙158后，如果要对局部组织进行麻醉，以使患者觉得舒服些，可通过电极41向间隙内注入Lidocaine之类的适当的麻醉剂。然后将一种适当的混合物或与机体相容的树脂通过配件96，管子71，分流通路97，通孔98，液流通路42和电极41的侧口43导入间隙158中，这种树脂比如说是一种侧链可结晶(SCC)聚合物，如由加州的Landec公司生产的“lntelimer”Scc聚合物。电极探针41上的若干个侧口43有利于使混合物21均匀分布在各间隙内。本领域的技术人员可以认识到，可在高于人体正常体温的温度下将SCC聚合物之类的混合物以非结晶或粘性状态释放，在温度冷却至体温时再结晶。利用器械20的加热装置106，当混合物通过探头22导入时，通过将聚合物的温度保持在高于人体体温的某一期望温度，可以释放这种SCC聚合物。聚合物未导入组织151时，第一热电偶118可对聚合物的温度进行监控，以确保聚合物的温度高于其熔点。一旦SCC到达间隙158，随着其温度降至人体体温，它便开始结晶或凝固。
将上述SCC聚合物之类的混合物21用这样的方法注入间隙158和组织156后，它可以支持注射的局部区域的括约肌153。这种混合物可向尿道壁147提供集中的机械压力，增加尿道146的括约肌产生的闭合力。这样，通过括约肌153而延伸的尿道的直径得以减小，使尿道变窄，减轻了经尿道的尿液随意流失。将混合物21向尿道的四周注射，可使尿道及周围组织有足够的柔韧性，在自然放松状态下相当容易地闭合，而且膀胱收缩时，可使尿液很容易地流出。将混合物21注入组织间隙158，可防止在尿道146周围的组织内混合物的不希望的位置移动。
混合物21注入组织156后，把手72和92相对于控制柄61后退，以便使电极41和绝缘套管完全退回到导向管56内。然后，如果医生认为必要，可将器械20在尿道内旋转45°，再以类似方法使电极41和绝缘套管52送入；使组织156内形成间隙158并再次注入混合物21。目前认为，在一个给定疗程中，可向4至12个靶区内注射混合物21。另外，还有一种认识是，如果医生乐意，也可以将探头22的远端22b插入尿道更深一些，以用上述方法向脂肪组织152甚至向括约肌153导入或注射混合物21。
一旦将混合物21释放到组织151的预期的靶区157内，使电极41和绝缘套管完全返回到导向管56内，并将探头22自尿道146取出。治疗过程结束后，患者可稍加休息后再离开治疗室回家。
虽然在上面描述的方法中，要通过电极41向组织151施加射频能量以形成间隙158，但可以认识到，也可将混合物21注射到组织151的靶区157内而不必先形成间隙。这也落在本发明的范围之内。在这种过程中，将混合物21直接注入没有形成间隙158的组织151内。药剂导入组织151后，若不须向电极41提供射频能量将其加热，本发明的器械可用不导电涂层或不可滑动的绝缘套管52来包复电极41。
还可用本发明的器械20将混合物21如在人体温度下处于非结晶状态或粘性状态的可交连的胶原释放，加热以后，混合物发生交连或凝固。利用器械20，可将混合物导入如紧贴尿道壁147的粘膜下层组织159内，而不必使用加热装置106。虽然装置20将注射的胶原滞留在粘膜下层组织159内，不作进一步处理，但后来对电极41提供的射频、微波或其它电能将对胶原加热而使之聚合并凝固。胶原的固化会阻止其移动，从而增强了对括约肌153的支持作用。第二热电偶123可对组织151进行温度监控，以确保尿道壁147不被灼伤等等。胶原对括约肌123的作用机理和前面所述相同，可减轻尿液的随意流失。应当理解，治疗时可用其它的方法对混合物21加热，如感应加热，超声加热，电阻加热，用适当的化学物质起反应而进行化学加热或电磁加热等。这些方法都落在本发明的范围之内。这种治疗过程不必形成组织间隙158即可完成。
应当明白，在本发明的范围之内，可将上面所述的本发明的方法结合起来，或将某一方法作一些改动。例如，可使用器械20向粘膜下层组织注入SCC聚合物，然后将胶原注入该组织内，事先可形成间隙158，也可不形成间隙158。
图7至10示出了本发明的经尿道探针释放器械的另一个实施例。图中器械171和器械20大体上类似。附图中，相同的参考数字表示相同的部件。器械171包括至少一个空心探针或电极。更具体地说，器械171具有第一组空心探针或电极172，它们和器械20的电极41类似。此电极具有两相对端，即第二端或近端172a和第一端或远端172b，见附图。每个第一电极172具有一延伸于远端172a和近端172b之间的液流通路173，由图9中局部示出。每个电极172的自由端或近端172a至少具有一个开孔，在开孔177处有一尖端176，液流通路173延伸至此尖端。
同轴安装的电极172和绝缘套管52彼此可相对滑动，且它们可滑动地安装在导向管56内。第一电极的另一端或远端172b固定在汇流盘66上，汇流盘装在歧管178上，歧管178和歧管67大致相同。绝缘套管52的第一端或远端52b安装在活塞81上。歧管178和活塞81允许电极172和绝缘套管52可相对于通孔36和探头远端22b滑动，从而使电极和绝缘套管大致在一个平面内自探头伸展，电极和各自的套管在所在的平面内以大约90°分开。
器械171还包括另外一组，或称第二组四个空心探针或电极181，它和第一电极172基本相同，它安装在探头22上并和第一电极172邻近。和绝缘套管52基本上相同的第二绝缘套管182和第二电极181同轴可滑动地安装，第二电极和绝缘套管可滑动地安装在第二导向管183内。探头22上开有第二组四个通孔186。通孔186绕纵轴27沿周向以大约90°间隔分布，各第二导向管183的近端均固定在相应的通孔186中。
器械171的操作装置191和器械20的操作装置63基本相同。操作装置191既可使电极172，181以及套管52，182同时伸展，又可使它们同时后退。如同操作装置63一样，器械171的操作装置允许其电极和相应的绝缘套管作相对运动。
操作装置191包括前面所述的探针，绝缘把手72和把手91，汇流盘66，歧管178和活塞81。它还包括第二汇流盘192和歧管193，它们大致和汇流盘66和歧管67相同，第二电极181安装在该汇流盘和歧管上，从而将电极驱动。第二绝缘套管182安装在第二活塞196上，活塞196大致和装有器械171的绝缘套管52的活塞81相同。由不锈钢之类的合适材料制成的推/拉杆197在探头22中沿纵向穿过活塞81和196，汇流盘66和192。杆197固定在歧管178和193上，并固定在探针把手72上，以便使电极172和181在相应的导向管56和183上移动。把手72和心杆198同心可滑动地装在一起，心杆198安装在端壁62的中央并大致上沿纵轴27延伸。把手72上有一供心杆198穿过的中心孔。探头22的远端22b里的沿纵向伸缩的回复弹簧201迫使器械171的第一和第二探针电极171和181向其远端位置移动或向回缩位置移动。弹簧201的近端固定在形成在歧管178上的舌片202上，远端固定在位于探头22的钝端33的尖部之内的小环203上。
由不锈钢等适当材料制成的第二推/拉杆201沿纵向穿过滑动地装在器械171的探头22内的第二汇流盘192和歧管193，并由适当的方法如粘合剂将其固定在器械内的活塞196和81上。杆201的近端穿过控制柄61的端壁62、探针把手72并可滑动，并固定在绝缘把手91上，从而可使器械171的绝缘套管展开和缩入。把手91可滑动地安装在中央心杆198上，其中具有中央通孔供心杆198穿过。
器械171包括一连接于探针22的近端22a上的装置，用于将混合物21导入电极172和181的液流通路。此装置，或称供药装置，具有沿纵向穿过器械171的管子211，管子211具有一和歧管178内的分流通路196和第二歧管193上的类似分流通路(未示出)相连通的中心管腔(未示出)。管子211的近端部211a穿过侧壁26上的一纵长形槽212，其端部装有一配件213。槽212使得管子211的近端部211a和歧管178和193可一起相对于探头22远近移动。
器械171和器械20的使用方式基本相同，不同之处在于，医生拉动而不是推动相应的把手72和/或91，使器械171的操作装置191将电极172、181和/或绝缘套管52和182展开。反之，向着控制柄61的方向推动器械171的把手72和91使得电极和绝缘套管缩入。
和上述器械20相比，附加电极181使得器械171可一次向组织151导入更多的混合物21。器械171的展开效率增加，使得治疗过程缩短，对病人141有益。采用这种拉式展开结构布局，在器械171中易于加入第二电极181。如图10所示，器械171特别适于将混合物21一次导入或注射到脂肪组织152和156中。
应该看到，在本发明的范围内，这里所提供的经尿道探针释放器械也可采用不同的结构布局。其一和探头22相似，但仅有一个空心探针或电极41，并在其远端处有相应的绝缘套管52。使用该器械时，随着器械在尿道146的预期部位绕纵轴顺序旋转，该单个电极和绝缘套管多次扎进组织151并向其释放药剂。另外，该器械的每个电极阵面中设置多于或少于四个电极都不超出本发明的范围。
尽管上面描述的本发明的经尿道探针释放器械和方法用于治疗女性的尿失禁，但应该看到，用该器械和/或方法对男性尿失禁进行治疗也属于本发明的范围。而且，在不涉及注射混合物21的过程中，用器械20或171对组织151进行射频灼除也落入本发明的范围。
上面已经给出了治疗尿失禁的器械和方法。利用此器械和方法可将药剂导入尿道周围的组织，增加对括约肌的支持。可采用射频灼除方法形成组织间隙，将药剂导入间隙内，并在导入过程中将其加热，以防止药剂在导入前发生凝固。如果必要的活，可在药剂导入组织靶区后利用射频能量或其它能量将药剂加热，以利于其在靶区内的固化。利用此器械和方法，可将药剂一次导入尿道周围组织内的多个靶区。

Claims (16)

1.一种用于女性体内的医疗器械，它向人体尿道周围的组织包括约肌组织的靶区释放一种药剂，尿道由自膀胱向体外延伸的尿道壁形成，所述器械包括：一细长探头部件，它具有一近端、一远端和一纵轴，所述细长探头部件的尺寸适于进入尿道，当其远端处于组织的靶区附近时，其近端位于尿道之外，所述探头部件具有自其近端向远端延伸的通道；至少一个空心探针置于所述通道内，所述探针具有第一端、第二端和液流通路，该通路自第一端沿纵向向所述至少一个空心探针的第二端上的至少一个开口延伸；一控制柄，它固定在所述细长探头部件的近端；操作装置，它装在所述控制柄上，并和所述至少一个空心探针的第一端连接，以便使所述至少一个空心探针沿通道运动；一装置，它安装于细长探头部件上，用以使所述至少一个空心探针沿一曲线路径和纵轴成某一角度伸展；一装置，它安装在细长探头部件的近端并和所述探针的液流通路连通，用于将药剂导入液流通路，从而在所述操作装置的控制下，当所述至少一个空心探针被扎进而穿过尿道壁时，所述空心探针的第二端上至少有一个开口进入靶区，以使药剂通过液流通路和空心探针上的开口进入靶区，从而增加对括约肌的支持。
2.如权利要求1所述的器械，其特征在于，所述至少一个空心探针为一由导电材料做成的电极，一绝缘套管和该导电电极同轴安装。
3.如权利要求2所述的器械，其特征在于，操作装置和绝缘套管连接，从而使绝缘套管和导电电极相对运动。
4.如权利要求1所述的器械，其特征在于，安装在细长探头部件内的所述装置使得所述至少一个空心探针沿一曲线路径移动而沿径向自纵轴放射状伸展。
5.如权利要求1所述的器械，其特征在于，所述至少一个空心探针上包括多个和液流通路连通的侧口。
6.如权利要求1所述的器械，其特征在于，所述至少一个空心探针涵盖了具有第二端的多个空心探针，操作装置和多个空心探针相连，装在细长探头部件上的装置使空心探针沿和纵轴成某一角度延伸的曲线路径运动，从而使探针的第二端大致在和纵轴基本垂直的平面内沿周向间隔分布。
7.如权利要求6所述的包括具有第二端的第二组多个空心探针的器械，其中，操作装置和第二组多个空心探针相连，装在细长探头部件上的装置使第二组多个空心探针沿曲线路径和纵轴成某一角度伸展，从而使第二组多个空心探针的第二端大致在和纵轴基本垂直的第二平面内沿周向间隔分布，该第二平面和第一平面沿纵向隔开一定距离。
8.如权利要求1所述的包括第二空心探针的器械，其中，操作装置和第二空心探针相连，装在细长探头部件上的装置使第二空心探针沿曲线路径和纵轴成某一角度伸展，该曲线路径和所述至少一个空心探针的曲线路径纵向间隔开。
9.一种用于女性体内的医疗器械，它向尿道周围的组织内的靶区释放一种药剂，尿道由自膀胱向体外延伸的尿道壁形成，所述器械包括：一细长探头部件，它具有一近端、一远端和一纵轴，所述细长探头部件的尺寸适于进入尿道，当其远端处于组织的靶区附近时，其近端处于尿道之外，所述细长探头部件的侧壁上具有若干个沿周向间隔分布的通孔以及一自探头近端伸向远端的通道；若干个导向管置于通道内，其具有第一端部和第二端部，每一导向管都具有自第一端部向第二端部延伸并与侧壁上的开孔连通的管腔；由导电材料制成的空心射频电极，它置于管腔内且具有沿其长度延伸的液流通路，每一空心射频电极具有一自由端，其上有多个和液流通路连通的侧口，电极还具有一闭合尖端；一绝缘套管，它和每一个空心射频电极同轴安装；一控制柄，安装在细长探头部件的近端；操作装置，它装在控制柄上并和空心射频电极及绝缘套管连在一起，使空心射频电极和绝缘套管在每一管腔内运动；一装置，它装在细长探头部件的近端并和空心射频电极的液流通路连通，用于将药剂导入液流通路，从而，在操作装置的控制下，当绝缘套管和空心射频电极自侧壁上的通孔扎入时，空心射频电极扎入尿道壁，以使具有侧口的空心射频电极的自由端的至少一部分进入靶区并暴露于靶区，而且，当空心射频电极的自由端的一部分暴露于靶区时，绝缘套管穿入尿道壁，这样，当向空心射频电极供给射频能量时可灼除该电极的自由端部分附近的靶区内的组织而形成间隙，与此同时，绝缘套管可保护尿道壁不受射频灼除的影响，通过空心射频电极的液流通路和侧口可将药剂导入间隙内。
10.一种向人体尿道周围组织中的靶区内释放药剂的方法，该组织包括括约肌以及由膀胱伸向体外的尿道壁形成的尿道，该方法包括：将其自由端上至少具有一个开口的空心探针扎入尿道壁周围的组织内，从而使开口处于靶区内并将药剂导入靶区，以增加对括约肌的支持。
11.如权利要求10所述的方法，还包括：将靶区灼除以使之形成间隙并将药物导入该间隙中。
12.如权利要求10所述的方法，还包括：通过细长探头部件向空心探针提供药剂，并且当药剂通过所述细长探头部件时以高于体温的温度将药剂加热。
13.如权利要求10所述的方法，还包括：药剂导入组织的靶区后再将其加热。
14.如权利要求10所述的方法，其中，扎入和导入步骤包括：将其自由端上具有至少一个开口的多个空心探针沿一组大致的平面扎入尿道周围的组织，从而使开口处于靶区内，并将药剂导入靶区。
15.如权利要求10所述的方法，还包括：将其自由端上具有至少一个开口的附加空心探针扎入尿道壁周围的组织，该组织和先前所述空心探针同时扎入的组织沿尿道纵向隔开一定距离。
16.如权利要求10所述的方法，其中，扎进步骤包括：将其自由端上具有至少一个开口的空心探针扎入女性尿道周围的组织。
CN95197452A 1994-12-01 1995-11-30 带膀胱镜的经尿道针释放器械及治疗尿失禁的方法 Pending CN1173118A (zh)

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CN107485778A (zh) * 2017-08-07 2017-12-19 梁靖华 一种肛肠止痛仪及留置装置

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EP0797409B1 (en) 2004-06-16
CA2206304A1 (en) 1996-06-06
US5588960A (en) 1996-12-31
EP0797409A1 (en) 1997-10-01
JP2001527428A (ja) 2001-12-25
WO1996016606A1 (en) 1996-06-06
AU4411496A (en) 1996-06-19
EP0797409A4 (en) 1999-10-27
DE69533172T2 (de) 2005-07-14
DE69533172D1 (de) 2004-07-22

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