CN1316889A - 三尖瓣与三尖瓣整复术 - Google Patents
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Abstract
本发明涉及患有瓣膜返流疾患的心脏二尖瓣与三尖瓣整复术,所述心脏导管具有适宜于插入人体心脏二尖瓣或三尖瓣区的适当尺寸,所述瓣叶施术器件具有可通过所述心脏导管插入和能结扎对置的部分心脏瓣叶的适当尺寸,穿过相应瓣叶(122)和(124)的缝合线(120)可在体外系好。缝合线(120)可用一根或多根可通过心脏导管(126)引入和抽回的缝针进行定位,夹持器件(402)可夹持瓣叶(122)、(124)。
Description
一般而言,本发明涉及患有瓣膜返流疾患的心脏二尖瓣与三尖瓣整复术。更具体地说,涉及一种侵害性较小的心脏二尖瓣与三尖瓣整复术所采用的装置和方法。
二尖瓣返流,即血液在心脏二尖瓣出现返流,会导致心博效率降低。心室肥大和扩张等一类代偿性机制建议为防止心室功能进行性恶化而实施早期治疗手段。二尖瓣返流的图象化诊断可应用超声心动图法或经食管超声心动图法进行。特别是检测有缺陷瓣叶的接合情况以及返流点和返流方向有助于诊断和评价疾患的可能模式。
二尖瓣脱垂,即二尖瓣叶的黏液瘤变性,是北美地区诱发二尖瓣返流的最为常见的主要原因。三十多年前,风湿性心脏病在美国是诱发二尖瓣返流的最主要原因,它至今在发展中国家仍然是二尖瓣返流的最主要病因。慢性风湿性心脏病会导致一个或两个二尖瓣瓣尖的缩短、变形和僵硬,以及引起连合肌、乳头肌和腱索肌的结构性异常。贫血性二尖瓣返流(IMR),即因对瓣膜组织的动脉供血不足所造成的瓣膜组织贫血,是引发二尖瓣返流的占第二位的主要原因。研究表明,环状组织不规则和后乳头肌纤维变性及在下层心室壁产生瘢痕等有可能伴随IMR出现。二尖瓣返流在许多病例中都可通过一般称为瓣膜整复术的方法对原来瓣膜进行修整而达到整复。典型的整复方法涉及在采取心肺旁路措施下进行开胸手术和对前瓣叶的周边切除。整复还涉及到对索缚瓣叶的腱索重新接合或清除一些瓣叶组织以整复畸形和肿大的瓣叶。在某些情况下,瓣膜基底用环状整复环固定。对病致损伤严重和钙化明显的瓣膜需要进行更换。
除了这些整复技术外,另外一种可供选择的方法是进行前后二尖瓣瓣叶的边缘对边缘缝合术。边缘对边缘缝合在不对前瓣叶进行周边切除的情况下保证了瓣叶的接合,通常将其称之为“蝴蝶领结”整复术。“蝴蝶领结”整复一般采用居中缝合,虽然也可以使缝合靠近某一连合,或采用多重缝合来进行。居中缝合造成一种类似蝴蝶结的双口型瓣膜。
通过将病人置于体外循环状态,蝴蝶领结整复术可以在侵害性较小的情况下实施。进行开刀手术,以便可通过刀口施术于心脏的左心房。缝合后,闭合心房。这种整复可明显减少二尖瓣返流,同时相应增加射血的喷排量。
首先,本发明涉及一套包括心脏导管和瓣叶结扎施术器的手术器具。所述心脏导管具有适当尺寸,可插入到人体心脏的二尖瓣和三尖瓣区并实施手术操作。所述瓣叶结扎施术器的尺寸允许通过所述心脏导管插入并能将相对心脏瓣膜的施术部分结扎起来。
其次,本发明涉及一种对博跳心脏的二尖瓣和三尖瓣的整复方法,所述方法包括:
A)将所述心脏导管的末端插入心脏以便对瓣膜施术;以及
B)用通过所述导管插入的瓣叶结扎器将施术瓣叶结扎到起来。
第三,本发明涉及一套包括心脏导管和瓣叶结扎施术器的手术器具。所述心脏导管具有施术端、末端和能插进心脏的适当尺寸。所述瓣叶结扎施术器通过所述心脏导管插入,施术驱动器件由所述导管的施术端伸出,结扎器件由所述导管的末端伸出。
第四,本发明涉及一种包括两对夹臂的心脏瓣叶结扎器。每对夹臂具有将心脏瓣叶结扎起来的适当尺寸。两对夹臂可将两个相邻的瓣叶结扎起来。
第五,本发明涉及一种包括夹持器和结扎器的心脏瓣膜夹持器/结扎器型施术器,其中所述夹持器和结扎器由同一个苘轴伸出。
第六,本发明涉及一种包括两个对置颌叉的心脏瓣叶结扎器。其中一个颌叉有用于承载扣钉的结构,另一个颌叉上有用于承载扣帽的结构。
第七,本发明涉及一种包括可在内轴上滑动的柱塞和有适当尺寸可用于夹持心脏瓣叶的夹臂的夹持器。通过柱塞的滑动,使得心脏瓣叶与柱塞之间的相互作用将瓣叶推向夹臂。
第八,本发明涉及一种结扎器件,包括第一茼轴,具有可用于刺穿心脏瓣叶的尖钉的夹扣第一部件,可在第一茼轴上滑动的第二苘轴,以及具有可与夹扣第一部件尖钉相配合的开口的夹扣第二部件。夹扣的第二部件可在第一苘轴上滑动但不能在第二茼轴上滑动,使得第二茼轴可引导夹扣的第二部件趋向第一部件。
图1为心脏导管的一个实施例的侧视图。
图2为图1中心脏导管施术端透视图。
图3为将两个瓣叶夹持到一起的缝合线结的侧面图。
图4为线结推进杆的侧面图。
图5为用缝合夹夹持心脏瓣叶的透视图,截去部分心脏导管以便展示导管的内含结构。
图6为用内窥剪剪断缝合线的透视图。
图7为用夹持钢丝夹持心脏瓣叶的透视图,钢丝的另一端连有缝合线。
图8为每个瓣叶均被一根倒钩针所刺穿的心脏瓣叶的侧视图,倒钩针通过缝合线互相连接。
图9为图8中倒钩针的放大视图。
图10为用于推进和施放图8中倒钩针的推进杆的侧视图。
图11为带有软线的倒钩针的侧视图。
图12为被图11所示倒钩针刺穿的心脏瓣叶侧视图,推进杆抓住连接两个倒钩针的缝合线。
图13A为施术展开前一个带有相应施术器件的结扎器插入两个心脏瓣叶之间的侧视图。
图13B为图13A中结扎器件的夹臂在心脏瓣叶两侧展开的侧视图。
图13C为图13A中结扎器件的夹臂被推压和夹持瓣叶的侧视图。
图13D为结扎器件和施术器件到达锁定位置并使瓣叶紧密结合的侧视图。
图13E为施术器件取走后瓣叶被图13A结扎器固定在预定位置的侧视图。
图13F为用于表明将图13A中结扎器件同用于放置结扎器件的施术器件联结和脱离配合机制的剖视图。
图14A为一个由心脏导管引入的带有弹性预应力夹臂的夹持/结扎器件的透视图,部分心脏导管被切断拿开以便展示其内含结构。
图14B为图14A夹持/结扎器件的两个具有弹性预应力的夹臂脱离心脏导管束缚的透视图,部分心脏导管被切断拿开以便展示其内含结构。
图14C为施术器件释放后图14A有弹性预应力的结扎器件固定瓣叶的透视图,部分心脏导管被切断拿开以便展示其内含结构。
图14D为有弹性预应力夹臂的结扎器的另一实施例透视图,其中夹臂被制成弯曲型。
图15为连同抽吸夹持器件的针型结扎器的侧视图。
图16为朝向心脏瓣叶的配置于结扎施术器件旁边的夹持器件的侧视图。
图17为图16中夹持器件和结扎施术器件的放大视图。
图18A为图17夹持器件的剖视图。
图18B为图18A夹持器件另一实施例的部件分解视图,在这一实施例中应用了一个偏心轮,对杆状结构和可开合的颌叉进行了拆分。
图18C为图18B所示实施例的侧视图。
图18D为由茼轴施术端向颌叉端看过去的视图,其中表明了偏心轮在开、合两种状态下的位置。
图19A-C为图17结扎施术器件的剖视图,其中图19B的剖视取向与图19A和图19C相差一个直角,表面看不到的结构用虚线表示。
图19D为图19A扣钉与扣帽联结配合的侧视图,用虚线表示。
图20为有柱塞的夹持器件的侧视图,柱塞用于将瓣叶引向夹持器件的夹臂。
图21为有弹簧预应力夹臂和气囊柱塞的夹持器另一实施例侧视图,气囊柱塞可将瓣叶引向有弹簧预应力的夹臂。
图22为将尖钩作为夹持器件组成部分的侧视图。
图23为带有抽吸夹持器件的弹性结扎器的侧视图。
图24为用图23弹性结扎器结扎心脏瓣叶的侧视图。
图25为由施术器件承载的用于结扎心脏瓣叶的夹扣透视图。
图25A为第一施术器件中尖钉的侧视图。
图26为图25中夹扣与其引入装置的侧视图,其中夹扣的两个部分已相互对准。
图27为图26夹扣第一部件的前视图。
图28为图26夹扣第一部件的侧视图。
图29为图26夹扣第二部件的侧视图。
图30为图26夹扣第二部件的后视图。
图31为图26夹扣第二部件的侧视图,其取向与图29的取向相差90度。
图32为图26夹扣两个部件密切配合的侧视图。
图33为弹性预应力环处在负荷状态的剖视图。
图34为图33弹性预应力环处于伸展状态的剖视图。
图35为卷叠环处于非卷压状态的侧视图。
图36为图35卷叠环卷压之后的侧视图。
图37为弹性结扎器件被施术器件送向心脏瓣叶施术位置的透视图,其中部分心脏导管被截断取走以便展示其内含结构。
图38为图37施术器放置环型结扎器件后的透视图。
图39为置于心脏瓣叶附近的自动缝合装置的一个实施例的侧视图。
图40为图39自动缝合装置用针夹持心脏瓣叶的侧视图。
图41为图39自动缝合装置中一根针的剖视图。
图42为图39自动缝合装置所用超声焊接器件处于进行最后焊接位置的剖视图。
图43为自动缝合装置另一实施例的侧视图。
图44为图43自动缝合装置的透视图。
最佳实施例详述
为实施侵害性较小的二尖瓣整复发展了一些方法。虽然讨论集中在二尖瓣整复,这种整复术通过对所述程序和器具的修改也可用于三尖瓣整复。特别是,在不必将病人置于心肺旁路循环的情况下对搏动心脏实施整复术。
通过保持一个由体外到体内心脏区的通道,使得可对左心房和左心室施术,从而可实现二尖瓣的整复。用经过通道插入的适当器具可将二尖瓣叶夹起并将瓣叶的边缘夹持和结扎到一起。在本发明的某些实施例中,夹起、夹持和结扎程序可以同时实施,或者它们也可分别实施。可采用适当的图象化手段对操作进行观测和引导。对二尖瓣的整复操作可在超声或荧光透视手段的监测下进行,以观测和引导器具到施术的正确部位,保证整复的有效性。
将器具引入心脏的一种直接法是通过一个穿通心壁的通道直接引入。为将这一通道或心脏导管插入体内,需要在胸部开一个较小的刀口。如下面将要说明的,一般需采用导管定位手段引导心脏导管到心脏的适当位置。在引入心脏导管时选用适当的引导和定位器具可减少心脏所受的创伤。二尖瓣整复术完成后,所用器具由心脏导管中取出,心脏导管由体内取出,对心壁上的刀口进行整复,例如进行缝合。
或者,还可以通过脉管法将器具引入心脏。在这种方法中,导管被引入动脉或静脉然后引导到心脏。这类脉管法将在后面叙述。
适用的夹持和结扎器具应具有适当的尺寸,能通过心脏导管对心脏施术。一般说来,这类器具在施术端和末端之间有一个柔性的管状结构。器具的末端通过心脏导管插入心脏。夹持和结扎器件位于器具的末端。一个或多个驱动器件位于施术端。
在某些实施例中,由单一器件实现夹持和结扎功能。换句话说,结扎器件在结扎过程中也能夹持组织,没有分立的专门用于夹持的器件。例如,可对穿过瓣叶的缝合线做适当布置,拉紧缝合线时也使瓣叶两部分聚拢。
或者,夹持和结扎器件也可为截然分开的分立器件。在某些实施例中,功能上截然不同的夹持和结扎器件可整合为一个器件,从而仅需要一个茼轴。或者使不同的夹持和结扎器件位于各有茼轴的不同器具之中。如果夹持和结扎器件位于不同的器具中,器具的茼轴尺寸应能使这两个茼轴同时通过一个心脏导管引入。或者,还可以将另外的一个或多个心脏导管引入心脏,为不同的夹持和结扎器件以及其他便利施术的器件提供通道。同时,也可用另外的一个或多个心脏导管为形象化观测和引导提供手段。器具
二尖瓣整复器具通常包括夹持/结扎器件、心脏导管和其他适用导管。心脏导管一般包括可伸缩的茼轴及有端口的施术端和末端。例如,心脏导管可以是一个标准的可置于脉管之中的导管或类似器件。心脏导管126的一个实施例如图1所示。如图2所示,施术端102包括端口104,夹持器/结扎器等施术器件通过它引入。施术端102最好还要包括一个止血伐106,以防止血液从心脏导管流出。用于导管技术中的标准设计可施用于止血伐。
心脏导管100的茼轴108最好是柔性的,以便能被引导到体内预期部位。一般而言,茼轴108的长度在4-15cm左右,直径为3-10mm左右,较为适用的直径大约为3-8mm。苘轴108可根据具体操作选择适当的长度。苘轴108的一端最好形成锥形110,便于将心脏导管100顺利引入到心脏中。
夹持/结扎施术器件可以是同时完成夹持和结扎两种功能的一个施术器件(如图19所示),或者是一个用于实现夹持功能、另一个用于实现结扎功能的两个施术器件(如图17所示)。两个功能器件可以整合为一个器具,也可作为通过心脏导管引入的两个分立器具进行操作。按需要和设想,可以应用一个或多个心脏导管。具体实施例将在以下进行叙述。
第一种夹持/结扎施术器为实施夹持和结扎两种功能的一个器具。第一种夹持/结扎施术器基于将瓣叶结扎到一起的缝合。
参阅图3,穿过相应瓣叶122和124的缝合线120可在体外系好。缝合线120可用一根或多根可通过心脏导管126引入和抽回的缝针进行定位。一个线结推进器件130(图4)用于将在体外系好的线结推向瓣叶,从而使线结将瓣叶拉到一起。有各种线结推进器件和缝针的设计可用于达到这一目标。或者如图5所示,不用打结而是用缝合夹132来拉紧缝合线。用一个缝合夹推进器件134将缝合夹132推到接近瓣叶122和124的位置。缝合夹132的结构使得缝合线只能在一个方向上穿过缝合夹132。一旦缝合线120被系好或夹住之后,缝合线120可用内窥剪136或其他类似器件剪断,如图6所示。
图7描述了另外一种基于缝合的夹持/结扎器件的实施例。不是使缝合线穿过每个瓣叶,而是用一段一端连接缝合线150的钢丝152将缝合线150固定在瓣叶122和124的边缘。钢线152可以是像起博器导程那样的尖锐螺旋钢线,可旋入瓣叶122和124之中。如上所述,缝合线可在心脏外系好,线结可被推向瓣叶,然后将缝合线剪断。
单一夹持/结扎施术器件的另一实施例涉及应用带倒钩的针。参阅图8,带倒钩的针200穿透每个瓣叶122和124。如果整复要求对瓣叶做更进一步的束缚,则可应用更多的倒钩针。倒钩针200通过缝合线206相互相连。每个倒钩针200可以有多个倒钩208(图9)。每个倒钩针200都可应用一个推进杆210(图10)进行推动。推进杆210一般具有操作倒钩针200的能够张合的颌叉212。颌叉212由位于推进杆210手柄端216中的杠杆驱动。或者应用其他推进杆或驱动机制来操作倒钩针200,例如应用弹簧的驱动机制。
为了用尽可能短的的缝合线206来缝合瓣叶并有足够的柔性来操作倒钩针200,图8所示实施例可修改为如图11所示。每个倒钩针222有一个由针上延伸出来的钢丝224。两个钢丝224通过缝合线226相连。可按图8所述的同样方法对倒钩针222进行操作。参阅图12,带有颌叉212或类似结构的推进杆210可通过心脏导管126引入心脏并抓住缝合线226。推进杆210被旋转时将使缝合线226卷绕,最终使钢丝224卷绕。钢丝224的卷绕将倒钩针222拉紧,从而拉近瓣叶122和124。钢丝224最好由不锈钢等材料制作,它们要有足够的韧性,在由缝合线传送力的作用下可以卷绕,同时又要有足够刚度,不会在瓣叶122、124的负荷下松绕。
或者,缝合线可以直接连在每个倒钩针上且环绕其他针形成闭环。拉紧缝合线将会使倒钩针彼此拉近。另外的线结可通过心脏导管126由体外推下,使两个缝合线固定连接在一起。
在另外的一个单一的夹持/结扎施术器件的实施例中,应用了一个可展开的夹持/结扎施术器件。例如参阅图13A,一个可伸缩的杆筒状结构250通过心脏导管126引入。外筒套254使夹臂256、258、260、262贴附在内芯264上。可伸缩的杆筒结构250插入到瓣叶122和124之间。参阅图13B,当外筒套254由束缚夹臂256、258、260和262的位置拉开后,不再受外筒套254束缚的夹持器件得以展开。
随着夹臂256、258、260和262在瓣叶122、124的两侧展开,按箭头266(图13C)所示方向内芯264向内拉,外筒套254向外推,使夹臂相互压紧,从而使瓣叶得到夹持。参阅图13D,夹臂256、258、260和262将瓣叶夹持到位。夹臂256、258、260和262沿内芯264的相对位置由挡销270限定。夹臂256、258、260和262的展开程度超过平衡位置,恢复力的作用是将夹臂拉向内芯264。参阅图13E,内芯264的端头272在夹持住瓣叶122和124时通过解开一个锁定机制而同内芯的主体部分分离,从而使瓣叶夹持在夹持器件上,然后将内芯264通过心脏导管126取出。锁定机制可由各种可夹持瓣叶122和124的传统结构来实现。图13F描述了一种适用的锁定机制,枢轴锁舌280锁定在凸缘282中,金属线284可用于使锁舌280脱离凸缘282。夹臂256、258、260和262的长度一般为2-10mm左右。内芯直径一般为1-8mm。
图14表明本发明的一个类似实施例。在一个夹持/结扎施术器件中,夹臂302、304、306和308带有弹性预应力。当夹臂302、304、306和308由心脏导管126的端口300中推出时,弹性预应力使它们得以展开。在图14B中,描述了带有展开夹臂302和306的夹持/结扎施术器件300。夹臂302和306具有可刺穿瓣叶122和124的尖锐尖头314。如图14C所示,当夹臂304和308脱离心脏导管126的束缚后,在瓣叶122和124一侧展开的夹臂304和308与在瓣叶另一侧展开的夹臂302和306将瓣叶122和124夹持起来。夹臂304、308具有可使尖头314、316紧密连接的扣钩322、324,从而使夹臂302、304、306、308可将瓣叶122、124紧密夹持在中间。通过旋转旋钮328使旋钮328穿过基座332中的通道330,可使夹持/结扎器件300同施术器件326分离。在另外一个实施例中,夹臂302、304、306、308如图14D所示制成弯曲形状。
第二类夹持/结扎施术器具包括夹持器件和结扎器件等两个分立器件。夹持器件和结扎器件可分置于两个不同茼轴的末端。对某些实施例来说,夹持器件和结扎器件可集合在一个筒套中但可分别操作,以适应施术中夹持和结扎的操作要求。这样,通过心脏导管引入的是一个筒套。
图15描述了两个不同的夹持和结扎器件集合在一个筒套中的实施例。夹持/结扎施术器件具有一个沿内管344盘绕的螺旋针342。第一步通过开口346经内管344内腔的抽吸将瓣叶夹起和保持在内管附近的一个位置。当瓣叶被抽吸夹持后,螺旋针旋转向前。外筒套343的旋转使螺旋针342穿通瓣叶122、124。螺旋针342固定在可围绕内管344旋转的外筒套343上。外筒套可刻有螺纹以提供适当的螺距和转数。为将瓣叶夹持在适当位置,通过解开位于外筒套343端部345上的夹片等一类器件使螺旋针342同外筒套343分离。如果需要,螺旋针可叠扎起来以保持持久附着。如图15所示基于抽吸作用的夹持器件也可同其它型式的结扎器件连用。
参阅图16-17,施术器具400包括由茼轴406中伸出的夹持器件402和结扎器件404。如图17所示,夹持器件402和结扎器件404可以配置在相邻位置。夹持器件402和结扎器件404可在一个导管、导轨或类似结构中运动,从而产生相对位移。夹持器件402和结扎器件404的相对位置可以掉换。在图17中,结扎器件404处于由末端抽回的位置,夹持器件402可夹持瓣叶122、124。然后,结扎器件404在退后位置张开并向前运动,将扣钉装在被夹持的瓣叶边缘。因此,夹持器件402相对于瓣叶122、124的定位最好如图16所示。
夹持器件402的一个实施例如图18A所示。在这一实施例中,蟹钳形夹持器件412具有对置的可开合的颌叉414、416,在闭合状态其锯齿形边缘418和420相互咬合。锯齿形边缘有助于对瓣叶122和124的夹持。杆状结构422的伸缩运动通过杠杆424的动作改变颌叉414的相对位置。杆状结构422由茼轴406中向苘轴406的末端伸出,使得施术者可在病人体操作外杆状结构422。颌叉414、416的长度应当满足在瓣叶122、124之间间距为最大预期值时仍能夹持瓣叶122和124。如果需要,夹持器件412可用不同于引入结扎器件的另一个茼轴引入。用于夹持瓣叶122、124的夹持器件412的设计如图16、17和18所示。
图18D描述了一个与图18A所示应用杠杆机制不同的另一实施例,采用一个偏心轮来旋转颌叉。具体地说,颌叉411围绕支轴413转动。杆状结构415的旋转改变了球417相对于杆状结构415的位置。球417与颌叉411末端的导轨419相配合,也与杆状结构415末端的一个不在中心位置的槽口相配合,从而杆状结构415的转动可使球417上下运动。球向下运动导致颌叉411相对于颌叉421张开。利用杠杆423使杆状结构415转动,如图18D所示。一般而言,杆状结构415转半周相当于使颌叉411由其闭合状态转变为张开状态。
如图17所示,结扎器件404使用了一个结扎元件,例如一个扣钉。有关结扎器件404的细节可参阅图19。结扎器件404分别有装载扣钉424和扣帽426的凹槽。当颌叉428、430由于杠杆432按图19A中箭头431所示方向运动而张开时,杆状结构434将扣钉424滑入导轨436中的适当位置同扣帽426相互对准,如图19B和图19C所示。颌叉428、430通过杠杆臂438或偏心轮等其他机械连接作用而产生相对转动。当颌叉428、430随后闭合时,扣钉424与扣帽426相互配合,如图19D所示,从而将瓣叶122和124结扎在一起。颌叉428、430可以张开以施放扣钉424从而将瓣叶122、124结扎在一起。
上述夹持器件和结扎器件可用于心房法和心室法,其他有些夹持器件是为在心房法中用于夹持瓣叶而设计的。参阅图20,夹持器件438具有用于夹持瓣叶122和124的夹持结构440。为将瓣叶推向夹持结构440,柱塞446包括两个或多个臂450、452。在图21所示的另一实施例中,使用了气囊柱塞454。气囊柱塞在通过心脏导管放置和取走器具时被抽瘪,在心脏内被充涨以用于将瓣叶引向夹持结构440。
在使用柱塞的这两个实施例中,都可拉动茼轴456而将有弹性预应力的夹持器件440拉向柱塞446或454,从而使瓣叶122、124被夹持在夹持结构440中。或者,柱塞446或454可将瓣叶122、124推向夹持结构440。在任何一种情况下,当柱塞446或454到达相对于夹持结构440某一特定位置使得夹持结构440可接触到瓣叶122和124时,将茼轴456拉回使得夹持结构440回缩,夹持结构440将瓣叶122、124扣定在在夹持结构440夹持管441之间。在瓣叶122、124被扣定之后,气囊446、454即可收回。在瓣叶122、124被夹持之后,可通过茼轴456的伸缩施放夹持结构440,使夹持器件438缩回。夹持结构440的长度应小于10mm。夹持结构可以是弯曲型的。
图22描述了另一种由心房侧夹持瓣叶的方法。钩针470、472通过心脏导管126引入,用于夹持瓣叶122、124。钩针470、472最好具有无倒钩的针尖480、482。一旦瓣叶122、124被夹持在一个适当位置,所叙述的各种结扎器件都可用来结扎瓣叶122和124。在瓣叶122、124被良好结扎后,通过推动和转动钩针470、472使其与相应瓣叶122、124脱离并将其取出,转动钩针470、472是使其在回收过程中不会再钩住瓣叶122、124。
用某种夹持器件的实施例夹起瓣叶,一般都可用另一种夹持器件来替换它夹持瓣叶。有各式各样的夹持器件可适用于夹持已被夹起的瓣叶。这样,如果愿意的话,一种结扎施术器可与多种适用的夹持器件连用。换另一角度说,对于要结扎的瓣叶可用多种夹持器件来进行夹持。例如,图22所示的钩针可用于夹持一个瓣叶,而图18D所示颌叉可用于夹持其他瓣叶。再如,也可使用两套颌叉,每一个用于夹持一个瓣叶。
关于结扎施术器具,图23-24描述了一个弹性结扎器件的实施例。在类似图15所述器件的抽吸作用下,瓣叶122、124被抽吸到空腔500、502中。通过腔管504可造成真空抽吸状态。通过旋转苘轴508可使弹簧506转动和对它进行推压。如图24所示,弹簧506的端头510钩住瓣叶,旋转弹簧506使得弹簧506通过瓣叶122、124卷绕,从而将瓣叶122、124结扎在一起。弹簧506通过瓣叶放置完毕之后,将腔管504抽出,真空释放。
参阅图25-32,结扎器件的另一个实施例使用了结扎夹扣540,它包括第一部件542和第二部件544。参阅图27-28,第一部件542包括由基体550的第一表面548中延伸出来的尖钉546。基体550在其第二表面554的边缘有凹槽552,位于相对于尖钉546旋转90度之处。在基体中心有一开孔556,开孔556带有朝向凹槽552的两个翼孔558。第二表面554包括位于开孔556附近朝向尖钉546的凹槽。
参阅图29-31,第二部件544包括直径等于或略小于尖钉546的孔眼566。凸缘568由基体572的第一表面570延伸而出。基体572包括带有两翼580的开孔578。考虑到凸缘568的结构,基体572不是绝对的圆周形。
图32表明第一部件542与第二部件分544联结配合的情况。当第一和第二部件542与544联结配合时,尖钉546插入孔眼566,凸缘568卡进凹槽552。瓣叶被夹持在基体550和572之间。
参阅图25,为施放夹扣540,使用第一施术器件580将第一部件542送到位。如图25A所示,第一施术器件580包括一个一端带有旋钮584的内芯582。在第一部件置于第一施术器件之上时,旋钮584与凹槽560相互配合,并且在取向适当时可穿过翼孔558,以便可取出第一施术器件580。第一施术器件580还包括可沿内芯582滑动的管状结构588。当旋钮584与凹槽560相互配合及管状结构588与第一表面548配合时,第一部件542被第一施术器件580牢固夹持。在用夹持器件夹持瓣叶之前,第一部件542最好置于接近瓣叶的位置。一旦夹起了瓣叶,第一部件542的尖钉546既可将瓣叶刺穿。
在尖钉546插入瓣叶之后,管状结构588可通过心脏导管126抽出。然后,第二施术器件590如图26所示沿内芯582滑动。第二施术器件590可将第二部件544推到相应位置,或者,在反向拉动第一部件542时,第二施术器件590可用线或夹板等夹持第二部件544。在第二部件544与第一部件542互相配合时,第二施术器件可通过心脏导管126抽出。使第一旋钮584穿过翼孔558和580,可将内芯582取出。夹扣540仍留在原处夹持着二尖瓣瓣叶。
结扎器的另一个实施例使用了变形环。可以应用各种型式的变形环。图33和图34描述了弹性变形环的一个实施例。图33和图34描述了弹性变形环的第一个实施例。弹性环610在新月型构件604的端部具有第一尖钉602。第二尖钉606原位于新月型构件604的空腔608内。弹性环610位于第二尖钉606和表面612之间。在展开使用弹性环600之前,一个夹扣锁定构件614将第二尖钉606保持在新月型构件604中。当锁定构件614释放后,第一尖钉602和第二尖钉606刺穿瓣叶并将它们夹持在一起。在弹性环的另外一些实施例中,可使用尖钉分别由各弹簧推动的双环结构。或者在需要时也可将尖钉作成可回收的,这样可利用变形环来夹持瓣叶,而采用其它结扎方法对瓣叶进行结扎。
参阅图35和图36,卷叠环630包括尖钉632、634和曲柄636、638。在曲柄636和38之间有一个凹槽641。如图36所示,凹槽641在使尖钉632和634互相接近的卷叠中起着弱弯曲部位的作用。卷叠环630放置在接近需要夹持的瓣叶附近。然后反向转动曲柄636和638使卷叠环处于如图36所示的闭合位置,尖钉632、634从而刺穿相应瓣叶。
弹性环600和卷叠环630等变形环可通过施术器件640进行放置和使用,如图37和图38所示。变形环642被引入到接近瓣叶122和124的位置,然后变形,利用尖钉等将瓣叶122、124刺穿。施术器件641包括杠杆臂650或其它适用结构,以有助于变形环600和630的放置和使用。例如,对弹性变形环600,使用杠杆臂650或其它结构以释放锁定结构;对卷叠环630,使用杠杆臂650来抓住曲柄636、638并使它们转动,将尖钉632、634拉近使得卷叠环成闭合形。
一种自动缝合装置可被用于作为结扎器。专利权人为Egan的美国专利5,417,700号描述了自动缝合装置的一个实施例,附录在此以供参考。参阅图39-42,缝合装置658包括可旋转刺穿瓣叶122、124的空心针660、662。缝合线664(图42)穿过空心针660和662中的针沟666(图41)。缝合线664可通过在砧底668和砧角670之间形成的超声焊接加以固定。在进行焊接前可将缝合线拉紧。
自动缝合装置的另一实施例如图43和图44所示。缝合装置700包括一个弯针702。弯针702具有针尖704和钝头706。弯针702放置在沟槽708中。缝合线710穿过针钩712。缝合线710由针钩712中穿出,穿过对面的开口进入沟槽708,然后系于弯针702-的钝头706。
拉动缝合线710使针702旋转,则针尖704会刺穿和钉住瓣叶122、124。为使针702穿过瓣叶122和124,针702大致要转动360度。在完成针的转动后,缝合线710对瓣叶122、124进行缝合。通过心脏导管回收缝合装置700将拉动穿过瓣叶122、124的缝合线710。如以上在图3中所述,缝合线710也可打结,以固定瓣叶122、124。或者如图5所示,用一个缝合夹132来固定缝合线710。
所有上述的装置和器件都可用标准的具有生物相容性的材料制作,包括不锈钢、钛等金属材料和多硫化物等聚合物材料。应针对具体应用选择合适的材料。此外,结扎器件的表面可有镀层或涂层,例如使用聚四氟乙烯(即泰福隆)以改善表面性质和采用银及银合金等抗菌金属镀层。关于抗菌金属镀层,在Ogle等人的美国专利申请流水号No.08/974,992标题为《带有抗菌金属附着物的医学物品》中有详细叙述,在此提及以便参考。
手术操作程序
在操作程序的最佳实施例中,整复是在心脏保持博动的情况下进行的。或者,也可选择在施术中使心脏停止跳动的方法。通过给心肌施用含钾冷溶液等一些化学药物可诱导心麻痹,即终止心脏收缩。化学药物导致的心麻痹要求将病人的心脏和主动脉同病人血管系统的其它部分进行隔离。一般不大愿意采用心麻痹的方法,因为它要求有心肺旁路,会增加病人的风险程度。
对基于心脏导管的一些实施例,要用到在病人胸部的一个或多个引入点,引入点一般开在相邻肋骨之间。引入点提供了可对心脏施术的通口。通过开刀手术制造引入点。像在腹腔镜操作程序中使用的套针鞘等器件可方便引入点的使用,在公开的PCT申请WO94/18881(StanfordSurgical Technologies,Inc.)中对此有详细描述,在此提及以便参考。或者,也可采用儿科开胸手术使用的软组织牵拉器等方法来帮助使用引入点。应根据要用的夹持/结扎器件及其合适途径来选择适当的引入点。
一旦触及心脏,可通过心壁插入一根引导线,或者通过心尖附近插入左心室,或者通过心脏顶部附近插入左心房。通过引导线滑入扩张器以扩张到心脏的通路。Daig Corp.,Minnetonka,MN可提供适用的引导线和扩张器。上面已做说明的带有止血阀的心脏导管随扩张器插入心区,以施放整复器件和器具。
或者,心脏导管也可由心壁上一个要求部位的刀口引入。像通常套管插入术一样,在心脏导管进入心脏后,可对导管的进入点做捆扎等处理,以减少出血。例如,捆扎处理可采用一段两端带针的缝合线。可通过夹、镊等对针进行操作。处理完成后,可用内窥剪将针剪断。如果需要,可在心脏附近和心脏中引入另外的心脏导管。
心脏导管到位后,夹持/结扎器件即可对二尖瓣或三尖瓣实施整复。所有这些器件和器具均经特别设计,使得保健专业人员可在心脏导管的施术端正确操作。
在“蝴蝶领结”整复完成后,将心脏导管取出。这种引入心脏导管的程序在不严重撕裂组织的情况下又能使组织分离,因而可减少对心肌的损害。对心脏导管进入心壁的进入口可用缝合、结扎等方法闭合。对心脏施术完成后,闭合通入胸腔的刀口。
或者,可采用侵害性较小的经皮脉管法。有两种可供选择的经皮脉管法可用于医疗程序中的导管置入。一种是使导管通过标准的插管器鞘进入股动脉,然后进入主动脉,再通过主动脉瓣进入左心室,使导管端口位于二尖瓣环之下。一般将这种方法称为“逆行法”。
另外一种一般称为经中隔法,是使导管通过经中隔插管鞘进入右股静脉,然后经下腔静脉进入右心房。通过穿刺动脉中隔卵圆窝使器具进入左心房,取走套针和扩张器件,将管鞘留在左心房中的适当位置。一旦将器具置于可对瓣叶施术的位置,即可按上述操作完成整复术。同需要进行腱索缩短、切除、腱索移位和人工腱索置换等复杂的和手术要求较高的方法比较而言,边缘对边缘二尖瓣整复术提供了一种简便和有效的整复技术。针对严重的离析性二尖瓣返流和在同冠状动脉旁路手术联合应用时,这种边缘对边缘的整复术更为有效。这种方法的优点在于:边缘对边缘整复不会带来打开心脏手术那样大的创伤,无须心肺旁路设施。因此,本程序可以伴随冠性动脉旁路移植(CABG)实施,或者在心脏导管插入技术实验室作为门诊程序而独立实施。其优点包括减少成本、住院时间和病人的康复时间。这种方法对病人的损伤较小,因此应在病情发展到严重程度前较早实行整复术,以免到病情严重时要做更多和侵害性更大的手术操作。
上述器具可成套提供。一套器具中一般包括一个结扎施术器和一个适用的心脏导管或一个适用于脉管法的导管。在这套器具中可能还包括一个可与结扎器联合使用的适当夹持器件。或者,一套器具中只有一个结扎器件(结扎施术器)和/或一个夹持器件。在成套器具中,最好还包括有说明二尖瓣和/或三尖瓣整复术的说明书,其中特别是含有具体使用结扎施术器和夹持器的操作规程。
虽然为说明起见描述了本发明的最佳实施例,但熟悉本门技术的人们都会了解,在不超出本发明所申明的权利要求的范围和要义下,在形式和细节上对本发明作出修改是可能的。
Claims (35)
1、一套包括心脏导管和瓣叶结扎施术器件的器具,所述心脏导管具有适宜于插入人体心脏二尖瓣或三尖瓣区的适当尺寸,所述瓣叶施术器件具有可通过所述心脏导管插入和能结扎对置的部分心脏瓣叶的适当尺寸。
2、如权利要求1所述器具,其中所述结扎器件包括对置的颌叉,一个所述颌叉具有放置和施用扣钉的结构,第二个颌叉具有放置和使用扣帽的结构。
3、如权利要求1所述器具,其中所述结扎施术器件包括夹扣。
4、如权利要求1所述器具,其中所述结扎施术器件包括穿过瓣叶的针和线。
5、如权利要求1所述器具,其中所述结扎施术器件包括具有适宜于固定心脏瓣叶合适尺寸的一些相互对置的夹臂。
6、如权利要求1所述器具,其中所述结扎施术器件包括一个环形器件。
7、如权利要求1所述器具,其中所述结扎施术器件包括夹扣,所述夹扣包括具有尖钉第一部件和扣合的第二部件。
8、如权利要求1所述器具,进一步包括一个夹持器件,所述夹持器件包括一个具有施术端和末端的管件,位于所述管件末端的夹臂,和位于所述管件施术端的驱动器件,所述驱动器件的动作可改变所述夹臂的相对位置。
9、如权利要求1所述器具,进一步包括一个夹持器件,所述夹持器件具有适当的开口可对心脏瓣叶产生抽吸作用。
10、如权利要求1所述器具,进一步包括说明所述心脏导管和所述瓣叶结扎施术器件使用方法的指导材料。
11、一种整复搏动心脏瓣膜的方法,所述方法包括:
A)将一导管的末端插入心脏以便对所述瓣膜施术;和
B)使用通过所述导管插入的瓣叶结扎器件将所述瓣膜的部分瓣叶结扎到一起。
12、如权利要求11所述方法,其中所述导管通过在所述搏动心脏心壁上的一个切口引入。
13、如权利要求11所述方法,其中所述导管通过血管引入到心脏。
14、如权利要求11所述方法,其中所述对瓣叶的结扎包括用尖锐突出物穿过所述瓣叶。
15、如权利要求11所述方法,其中所述多瓣叶的结扎包括将所述对置瓣叶缝合到一起。
16、如权利要求11所述方法,进一步包括在结扎所述瓣叶前用于夹持所述瓣叶的夹持器件。
17、如权利要求16所述方法,其中所述夹持器件包括一个具有施术端和末端的苘轴,对置的夹臂位于所述茼轴的末端,驱动器件位于所述茼轴的施术端,所述驱动器件的动作可改变所述夹臂的相对位置。
18、如权利要求16所述方法,其中所述夹持器件具有一个可对心脏瓣叶起抽吸作用的适当开口。
19、如权利要求11所述方法,进一步包括通过所述心壁引入一根线以启动一个开口,所述心脏导管通过所述开口插入。
20、如权利要求11所述方法,进一步包括为插入所述心脏导管在所述心壁开一刀口。
21、一种包括心脏导管和瓣叶结扎施术器件的器具,所述心脏导管具有施术端、末端和可插入心脏的适当尺寸,所述瓣叶结扎施术器件通过所述心脏导管引入,施术驱动器件由所述导管的所述施术端伸出,结扎器件由所述导管的末端伸出。
22、如权利要求21所述器具,其中所述施术驱动器件包括一段延伸到所述瓣叶结扎施术器件的所述末端的缝合线。
23、如权利要求21所述器具,其中所述施术驱动器件包括一个控制结扎器件施放的杠杆。
24、如权利要求21所述器具,进一步包括一个由所述心脏导管引入的夹持器件,所述夹持器件的夹持部件由所述末端伸出而驱动器件由所述施术端伸出,其中所述驱动期间控制所述夹持部件。
25、一种包括两对夹臂的心脏瓣叶结扎器件,所述每对夹臂具有适宜于结扎所述心脏瓣叶的适当尺寸,所述两对夹臂可结扎两个相邻瓣叶。
26、如权利要求25所述心脏瓣叶结扎器件,其中所述夹臂可向内芯折曲,所述结扎器件具有使一对所述夹臂在弹性应力下聚拢的一个锁定位置。
27、如权利要求26所述心脏瓣叶结扎器件,其中所述每对夹臂中有一个夹臂具有可刺穿一个瓣叶的突尖。
28、一种包括一个夹持器件和一个结扎器件的心脏瓣叶夹持/结扎施术器件,其中所述夹持器件和所述结扎器件由一个茼轴中伸出。
29、如权利要求28所述夹持/结扎施术器件,其中所述夹持器件包括两个对置的颌叉。
30、如权利要求28所述夹持/结扎施术器件,其中所述结扎器件包括两个对置的颌叉,所述一个颌叉具有放置扣钉的凹坑,所述另一个颌叉具有放置扣帽的凹坑。
31、一种包括两个对置颌叉的心脏瓣叶结扎施术器件,其中所述一个颌叉具有放置扣钉的凹坑,所述另一个颌叉具有放置扣帽的凹坑。
32、如权利要求31所述心脏瓣叶结扎施术器件,其中所述具有放置扣钉的凹坑的颌叉进一步包括一个凹槽,所述扣钉可在所述凹槽中滑动到与所述放置扣帽的凹坑相对应的位置。
33、一种包括一个可在内茼轴上滑动的柱塞和具有夹持心脏瓣叶适当尺寸的夹臂组成的夹持器件,其中所述柱塞的滑动可使所述柱塞与心脏瓣叶之间的相互作用将所述瓣叶推向所述夹臂。
34、如权利要求33所述夹持器件,其中所述柱塞为可抽瘪和充涨的气囊柱塞。
35、一种结扎施术器件,包括第一茼轴,具有可刺穿心脏瓣叶的尖头结构的扣夹第一部件,可在所述第一苘轴上滑动的第二苘轴,以及所述扣夹的第二部件。所述扣夹的第二部件具有可与所述扣夹第一部件的尖头相配合的开口,所述扣夹的第二部件可在所述第一茼轴上滑动但不能在所述第二茼轴上滑动,从而使所述第二苘轴可将所述扣夹第二部件引向所述第一茼轴。
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1999
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- 1999-06-23 WO PCT/US1999/014063 patent/WO2000003759A2/en active Application Filing
- 1999-06-23 EP EP99928841A patent/EP1096886B1/en not_active Expired - Lifetime
- 1999-06-23 AU AU45820/99A patent/AU4582099A/en not_active Abandoned
- 1999-06-23 CA CA002337089A patent/CA2337089C/en not_active Expired - Fee Related
- 1999-06-23 ES ES99928841T patent/ES2379338T3/es not_active Expired - Lifetime
- 1999-06-23 BR BR9912107-7A patent/BR9912107A/pt not_active Application Discontinuation
- 1999-06-23 JP JP2000559893A patent/JP2002520125A/ja active Pending
-
2000
- 2000-04-05 US US09/543,076 patent/US6695866B1/en not_active Expired - Lifetime
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2004
- 2004-02-23 US US10/784,674 patent/US20040167539A1/en not_active Abandoned
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
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CN107205817A (zh) * | 2014-12-04 | 2017-09-26 | 爱德华兹生命科学公司 | 用于修复心脏瓣膜的经皮夹具 |
US10524792B2 (en) | 2014-12-04 | 2020-01-07 | Edwards Lifesciences Corporation | Percutaneous clip for repairing a heart valve |
CN105902286A (zh) * | 2016-05-11 | 2016-08-31 | 中国人民解放军第七五医院 | 一种订书机式内镜缝合器 |
CN105902286B (zh) * | 2016-05-11 | 2018-11-02 | 中国人民解放军第一七五医院 | 一种订书机式内镜缝合器 |
CN109640836A (zh) * | 2016-08-18 | 2019-04-16 | 4科技有限公司 | 带有用于插入心包腔中的柔性尖端的组织锚 |
CN111163730A (zh) * | 2017-08-21 | 2020-05-15 | 爱德华兹生命科学公司 | 用于人工心脏瓣膜的密封构件 |
CN111163730B (zh) * | 2017-08-21 | 2021-10-01 | 爱德华兹生命科学公司 | 用于人工心脏瓣膜的密封构件 |
Also Published As
Publication number | Publication date |
---|---|
CA2337089A1 (en) | 2000-01-27 |
AU4582099A (en) | 2000-02-07 |
EP1096886A2 (en) | 2001-05-09 |
CA2337089C (en) | 2007-07-17 |
WO2000003759A3 (en) | 2000-04-20 |
JP2002520125A (ja) | 2002-07-09 |
US6165183A (en) | 2000-12-26 |
US20040167539A1 (en) | 2004-08-26 |
BR9912107A (pt) | 2001-04-24 |
WO2000003759A2 (en) | 2000-01-27 |
ES2379338T3 (es) | 2012-04-25 |
US6695866B1 (en) | 2004-02-24 |
EP1096886B1 (en) | 2012-01-11 |
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