CN106456144B - 二尖瓣环扎手术所使用的组织保护器具 - Google Patents
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Abstract
本发明涉及一种二尖瓣环扎手术所使用的组织保护器具,更详细地说,本发明涉及一种在对二尖瓣返流症患者实施的二尖瓣环扎手术中防止身体(心脏)内的组织受环扎线伤害的组织保护器具。本发明的二尖瓣环扎手术所使用的组织保护器具是用来插入环扎线(10a、10b)的中空圆柱型管,圆柱型管的一侧侧面形成有孔(22)而使得进入冠状静脉窦的用来插入冠状静脉窦的环扎线(10a)从上述圆柱型管出来,上述孔的下侧插入三尖瓣并保护三尖瓣与心室中隔的组织。
Description
技术领域
本发明涉及一种二尖瓣环扎手术所使用的组织保护器具,更详细地说,本发明涉及一种在对二尖瓣返流症患者实施的二尖瓣环扎手术中防止身体(心脏)内的组织受环扎线伤害的组织保护器具。
背景技术
心脏是一种扮演血液泵角色的器官。为了让肌肉所构成的该泵(心脏)动作,需要具备让血流不返流而朝一定方向流动的瓣(valve)。心脏具有两个心房(atrium)与两个心室(ventricle)等4个房室,这些房室与大动脉、静脉、肺动脉、肺静脉等4种血管连接。
位于左心房与左心室之间的瓣是二尖瓣(mitral valve,MV),位于右心房与右心室之间的瓣是三尖瓣(tricuspid valve,TV),位于左心室与大动脉之间的瓣是大动脉瓣(aortic valve),位于右心室与肺动脉之间的瓣是肺动脉瓣(pulmonary valve,PV)。
瓣应该根据心脏搏动而完全开放或闭合。如果出现没有完全闭合或没有完全开放之类的情形,就会让液体返流或者流动不良。这是心脏瓣病。心脏瓣疾病主要区分为,瓣需要闭合时却没有完全闭合而使得血液泄漏的疾病(返流,regurgitation)、瓣需要开放时却没有完全开放的疾病(狭窄,stenosis)。
所谓的二尖瓣返流症是一种这样的疾病,当作为左心房与左心室之间的瓣的二尖瓣需要闭合时却没有完全闭合而使得血液返流,该结果造成心脏负担而降低心脏功能,最后导致心功能不全。
目前为止,二尖瓣返流症的标准治疗是打开胸部的胸骨并切开心脏后修补二尖瓣或置换人造瓣的手术式治疗。其治疗效果虽然优异,但手术本身是一种可能导致5%患者死亡的危险的高侵袭性治疗方法。由于该限制,目前为止只有非常严重的二尖瓣返流症才会进行手术治疗。在这样的背景下,近来针对经皮二尖瓣成形术的开发做了很多研究,该成形术通过利用导管的较简单手术修补二尖瓣,而且该成形术不是要求打开患者胸部后切开心脏的手术。作为该国际性研究的一环,本发明人近来在国际论文发表了二尖瓣环扎手术(Mitral cerclage coronary sinus annuloplasty)(MVA),该手术对二尖瓣环(mitralannulus,MA)周围施加圆形压力而证明了优异的治疗效果。上述论文的内容已经申请了国际专利申请(国际申请号:PCT/US2007/023836)并且目前由国际事务局做了国际公开(国际公开号:WO2008/060553)。
下面针对上述论文与上述专利申请所说明的经皮二尖瓣成形术(二尖瓣环扎手术)予以简单说明,通过颈静脉接近右心房后让导管(catheter)位于“冠状静脉窦”,让环扎所需线通过“近端心室中隔静脉(proximal septal vein)”。该线能够轻易地从“右心室的肺动脉瓣下部(right ventricular outflow tract,RVOT)”之一处出来,本申请人将该手术方法命名为单纯二尖瓣环扎成形(simple mitral cerclage annuloplasty)手术。该线能够轻易地拉到右心房而使得环扎线位于二尖瓣环(mitral annulus)周围的组织。此时对该线施加压力就能发挥出勒紧二尖瓣环的效果,如此就能让二尖瓣的两个瓣叶更加接近地相接而得以减少瓣的非完全闭锁(incomplete closure)。该原理所达到的效果和直接勒紧二尖瓣环的手术式治疗非常相似,这样就能立刻减少通过二尖瓣返流的血液,从而得到治疗效果。
然而,三尖瓣(TV)因为环扎线(cerclage suture)横穿心脏内而可能会伤到瓣功能、造成瓣与其附属物受损。作为保护该身体(心脏)内组织的技术,本发明人构想了冠状静脉窦与三尖瓣的组织保护器具并且将其申请专利后得到注册(注册号:10-1116867,2012.02.08注册)。
发明内容
发明所要解决的技术课题
本发明改善了本发明人所申请的韩国专利第10-1116867号的发明,本发明的目的是提供一种二尖瓣环扎手术所使用的组织保护器具,其结构更加简单并且能像先前技术一样地在环扎手术中防止身体内的组织受环扎线伤害。
解决课题的技术方案
本发明能够达到上述目的,本发明的二尖瓣环扎手术所使用的组织保护器具是用来插入环扎线的中空圆柱型管,圆柱型管的一侧侧面形成有孔(hole)而使得进入冠状静脉窦的用来插入冠状静脉窦的环扎线从上述圆柱型管出来,上述孔的下侧插入三尖瓣并保护三尖瓣与心室中隔的组织。
根据优选实施例,上述圆柱型管包括:上部的干部;支持部,连接到上述干部并且在侧面形成孔,是上述孔的上下预设部位而且比三尖瓣插入部坚硬(rigid);及三尖瓣插入部,连接到上述支持部并保护三尖瓣与心室中隔的组织。更优选地,上述支持部的管的厚度比上述三尖瓣插入部更厚地形成。
根据优选实施例,上述圆柱型管的一侧侧面形成有突出部以便得知冠状静脉窦的位置。
根据优选实施例,上述用来插入冠状静脉窦的环扎线与上述用来插入三尖瓣的环扎线互相连接,上述用来插入冠状静脉窦的环扎线比上述用来插入三尖瓣的环扎线更坚硬(rigid)地形成。
根据优选实施例,上述圆柱型管的下端部形成有能防止深入心肌内的阻挡件,优选地,上述阻挡件是环形突出部。
根据优选实施例,上述组织保护器具为了包裹心室中隔内的环扎线而具有越到末端越细的结构。
有益效果
如前所述,本发明的二尖瓣环扎手术所使用的组织保护器具利用更简单的结构在对二尖瓣返流症患者实施的二尖瓣环扎手术中保护身体,不仅实现了手术的便利性,还能确保手术的稳定性。
附图说明
图1是根据本发明优选实施例的二尖瓣环扎手术所使用的组织保护器具的概略立体图。
图2是示出安装了根据本发明优选实施例的二尖瓣环扎手术所使用的组织保护器具的情形的心脏局部剖切虚拟图。
图3是根据本发明优选实施例的二尖瓣环扎手术所使用的组织保护器具的局部剖视图。
具体实施方式
下面结合附图详细说明本发明的二尖瓣环扎手术中使用的组织保护器具。
图1是根据本发明优选实施例的二尖瓣环扎手术所使用的组织保护器具的概略立体图,图2是示出安装了根据本发明优选实施例的二尖瓣环扎手术所使用的组织保护器具情形的心脏局部剖切虚拟图。
环扎线(cerclage suture)10指的是二尖瓣环扎手术(Mitral cerclagecoronary sinus annuloplasty,MVA)中使用的、其厚度大约为0.014"以下的非常细的线,由于一缕线如同画着圆形地围绕冠状静脉窦(coronary sinus,CS)部分与三尖瓣(tricuspid valve,TV)部分、心室中隔部分后来到体外而命名,来到体外时成为一侧末端与另一侧端的2缕线。亦即,图1所示环扎线虽然被区分为用来插入冠状静脉窦的环扎线10a与用来插入三尖瓣的环扎线10b,但如图所示地是画着圆形地连接成一体的线。环扎线的材质可以使用诸如尼龙之类的合成树脂或金属制(不锈钢、金属制上涂敷尼龙等)丝(wire)等。而且,也可以使用多个细丝搓捻后制成的丝等。环扎线10如果是由多条线(丝)搓捻而成的形态,也称为“环扎绳”、“环扎丝”,其也是一种环扎线。
组织保护器具20是用来插入环扎线10a和10b的中空圆柱型管。组织保护器具20为中空圆柱型管,亦即具备内腔,其粗细被制成大约为4Fr诊断用导管。材质则使用具软性(soft)、柔性(flexible)的橡胶材料乃至合成树脂材料。或者也可以使用涂敷了具生物相容性的合成树脂的金属制弹簧。
按照各部分区分的话,组织保护器具20由上部的干部23、中间的支持部26、下部的三尖瓣插入部24构成并且形成了一个较长的中空圆柱型管的形状。
本发明的组织保护器具在预设部位的侧面形成孔22,上述孔22是让进入冠状静脉窦的用来插入冠状静脉窦的环扎线10a从圆柱型管出来的部分。以孔22为中心的上下一定高度为支持部26,支持部的上部是干部23,支持部的下部是用来保护三尖瓣与心室中隔的三尖瓣插入部24。
用来插入冠状静脉窦的环扎线10a与用来插入三尖瓣的环扎线10b互相连接。插入冠状静脉窦的环扎线10a在冠状静脉窦内没有被管包裹,因此为了保护冠状静脉窦组织而比用来插入三尖瓣的环扎线10b更坚硬(rigid)地形成较佳。用来插入冠状静脉窦的环扎线10a比用来插入三尖瓣的环扎线10b更厚地形成以防止用来插入冠状静脉窦的环扎线导致冠状静脉窦组织受损。
支持部26在侧面形成有让用来插入冠状静脉窦的环扎线10a从组织保护器具20出来的孔22,支持部26连接到干部23并且形成于干部23的下部。
优选地,支持部26比干部23或三尖瓣插入部24更坚硬(rigid)地形成。这是为了在用来插入冠状静脉窦的环扎线10a通过孔出来时能够更稳定地给予支持。
图3是根据本发明优选实施例的二尖瓣环扎手术所使用的组织保护器具的局部剖视图。
如图3所示,支持部26的管的厚度比三尖瓣插入部24更厚地形成。这是因为支持部26比三尖瓣插入部24更坚硬(rigid)地形成较佳,作为其中的一个方法,让支持部26的管的厚度比三尖瓣插入部24更厚地形成而得以更坚硬地形成。当然,也可以让支持部的外径更厚地形成或者以其它材质形成而得以更坚硬地形成。
连接到支持部26的三尖瓣插入部26用来从插入三尖瓣的环扎线10b保护三尖瓣与心室中隔的组织。
圆柱型管的下端部(亦即,三尖瓣插入部的下端部)形成阻挡件24a以防止组织保护器具深入心肌内。阻挡件24a如图所示地是环形突出部。而且如图所示,圆柱型管的下端部(亦即,三尖瓣插入部的下端部)为了包裹心室中隔内的环扎线10b而具有越到末端越细的结构。
三尖瓣插入部26预先选择阻挡件(RVOT stopper)24a与孔22之间的长度以便让该长度成为利用预先得到的患者影像图等资料测量的右心室流出道(RVOT exit)与冠状静脉窦开口的距离的2倍左右的更长长度。亦即,让孔22到阻挡件24a之间的长度大约为阻挡件到末端部之间的长度的2倍左右地设计。为此,虽然可以在三尖瓣插入部26内改变阻挡件位置,但是当然也可以备妥孔22与阻挡件24a之间的长度互不相同的各种组织保护器具。
从组织保护器具20出来的用来插入冠状静脉窦的环扎线10a插入冠状静脉窦的话,孔(hole)22部分被CS入口的边缘卡住。这样的话,三尖瓣插入部26的阻挡件(RVOT exitstopper)24a与孔22部分被固定,其间的三尖瓣插入部26按照其长度维持“倒转的C(reverse'C')”形状,其不紧靠在三尖瓣TV周边而呈浮起的状态。其作用为防止环扎线10造成三尖瓣的损伤(erosion),还能较不限制瓣瓣叶的动作。
另一方面,组织保护器具20可以如图所示地在外面形成突出部27。突出部27除了被身体内的组织卡住而使得组织保护器具无法进一步插入以外,还能在三尖瓣插入部26形成“倒转的C(reverse‘C’)”型形状时作为对一侧给予支持的部分。
前文说明的内容仅是较佳实施例,不能由上述实施例限定本发明的权利范畴。本发明的技术范畴显示在权利要求书,本领域技术人员可以在权利要求书所记载的发明思想或范畴内实现各种变化、置换及修改。
产业上的用途
本发明涉及一种二尖瓣环扎手术所使用的组织保护器具,更详细地说,本发明可应用于在对二尖瓣返流症患者实施的二尖瓣环扎手术中防止身体(心脏)内的组织受环扎线伤害的组织保护器具领域。
Claims (9)
1.一种二尖瓣环扎手术所使用的组织保护器具,其特征在于,其为用来供冠状静脉窦环扎线(10a)及三尖瓣环扎线(10b)的环扎线(10)插入的中空圆柱型管,圆柱型管的一侧侧面形成有孔(22),并且通过所述孔(22)使得进入冠状静脉窦的用来插入冠状静脉窦的冠状静脉窦环扎线(10a)从上述圆柱型管出来,从而冠状静脉窦环扎线(10a)从上述圆柱型管出来后进入冠状静脉窦中,并且所述冠状静脉窦环扎线(10a)在冠状静脉窦中不被所述中空圆柱型管包裹,
上述孔的下侧形成为被插入三尖瓣并保护三尖瓣与心室中隔的组织。
2.根据权利要求1所述的二尖瓣环扎手术所使用的组织保护器具,其特征在于,上述圆柱型管包括:
上部的干部(23);
支持部(26),连接到上述干部并且在侧面形成孔,所述支持部(26)是上述孔的上下预设部位而且比三尖瓣插入部坚硬;
三尖瓣插入部(24),连接到上述支持部并保护三尖瓣与心室中隔的组织。
3.根据权利要求2所述的二尖瓣环扎手术所使用的组织保护器具,其特征在于,上述支持部的管的厚度比上述三尖瓣插入部厚。
4.根据权利要求1所述的二尖瓣环扎手术所使用的组织保护器具,其特征在于,上述圆柱型管的一侧侧面形成有突出部(27)以便得知冠状静脉窦的位置。
5.根据权利要求1所述的二尖瓣环扎手术所使用的组织保护器具,其特征在于,上述用来插入冠状静脉窦的冠状静脉窦环扎线(10a)与上述用来插入三尖瓣的三尖瓣环扎线(10b)互相连接,上述用来插入冠状静脉窦的冠状静脉窦环扎线(10a)比上述用来插入三尖瓣的三尖瓣环扎线(10b)更坚硬地形成。
6.根据权利要求1所述的二尖瓣环扎手术所使用的组织保护器具,其特征在于,上述圆柱型管的下端部形成有能防止深入心肌内的阻挡件(24a)。
7.根据权利要求6所述的二尖瓣环扎手术所使用的组织保护器具,其特征在于,上述阻挡件(24a)是环形突出部。
8.根据权利要求1所述的二尖瓣环扎手术所使用的组织保护器具,其特征在于,上述组织保护器具为了包裹心室中隔内的环扎线而具有越到末端越细的结构。
9.根据权利要求6所述的二尖瓣环扎手术所使用的组织保护器具,其特征在于,上述孔与上述阻挡件之间的组织保护器具在进行环扎手术时成为倒转的C形状地不紧靠在三尖瓣周边而呈浮起的状态。
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