CN103153231A - 用于退变性疾病的二尖瓣成形术的简化方法的瓣环成形术带 - Google Patents
用于退变性疾病的二尖瓣成形术的简化方法的瓣环成形术带 Download PDFInfo
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Abstract
本发明基本上涉及一种用于修复心瓣膜的装置,并且更具体地涉及一种由半刚性敞开的带构成的改进的瓣环成形术带,半刚性敞开的带包括护套和布置在护套中的大体上弯曲的硬化半刚性元件,所述硬化半刚性元件从邻近前-侧三角的第一端延伸到邻近后-中三角的第二端,用以限定非平坦(非共面)复合C-曲线形状,以便在前侧和后侧模仿鞍状。
Description
技术领域
本发明基本上涉及一种用于修复心脏瓣膜的装置,并且更具体地说涉及一种改进的瓣环成形术带。
背景技术
大体上分类为瓣环成形术环或瓣环成形术带的瓣环成形术假体结合瓣膜重构手术一起使用,以有助于修正诸如狭窄和瓣膜功能不全的心瓣膜缺陷。在心脏中存在两个心房-心室瓣膜。在心脏的左侧上的心房-心室瓣膜称作二尖瓣,并且在右侧上的心房-心室瓣膜称作三尖瓣。在解剖学上来说,每个瓣膜类型都形成或限定瓣膜环与瓣叶。为此目的,二尖瓣与三尖瓣在解剖学上显著不同。然而二尖瓣的环略呈“D”形,三尖瓣的环更接近圆形。
两个瓣膜都可能受到或者招致损伤,这要求它们必须被修复或替换。瓣功能障碍的影响不同。对于患者来说二尖瓣回流比三尖瓣回流(其少量能够被容忍)具有更加严重的生理学后果。许多缺点与瓣膜环的扩张有关。该扩张不仅妨碍瓣膜功能而且还导致瓣口的正常形状的变形。因此对于二尖瓣上的大部分重构程序来说瓣膜环的重构是重点。在这点上,临床经验示出当技术上可能时,与瓣膜替换相比,瓣膜的修复产生更好的长期结果。
已经描述了多个程序以修正瓣叶及其相关的腱索及***肌的病理学。在二尖瓣的修复中,认为保持两个纤维三角之间的正常距离是重要的。三角几乎跨坐瓣膜环的前瓣叶部分。
三角间距离的显著手术减少可能造成左心室的流出障碍。因此,在二尖瓣修复手术过程中及其之后保持自然三角间距离是极为理想的。
因此,当修复二尖瓣时(后瓣叶或前瓣叶),结果通常是二尖瓣环的后部尺寸的减小。由于修复二尖瓣的一部分,瓣环的涉及部分减小(即收紧)以使瓣叶可以正确地接合封闭,并且使瓣膜环稳定以防止发生手术后扩张。这往往通过将假体环或假体带植入到上述环位置而实现。假体环或假体带的目的是限定和/或支撑瓣膜环以修正和/或防止瓣膜功能不全。然而,重要的是不过度限制瓣膜环否则可能导致不能接受的瓣膜狭窄。
如上所述,瓣环成形术环和瓣环成形术带可用于对于房室瓣的修复。
在其它瓣环成形术环中,由美国美敦力公司(Medtronic Inc.)生产的商标为“DURAN(TM)”的柔性瓣环成形术环是可获得的。一般地说,瓣环成形术环完全地包围瓣膜环的前部和后部。后部通常患病或扩张并且不能由心脏组织很好地支撑。对比之下,前部由周围的心脏组织很好地支撑。因此,可能的是瓣环成形术环可能过度地支撑否则健康的前部,极可能导致组织损伤。
在另一个方面,瓣环成形术带,具体地设计为主要地仅包围瓣膜环的一部分。例如,二尖瓣瓣环成形术带通常地构造为仅包围二尖瓣环的后部,因此促进后部的自然移动。除了方便瓣膜环的健康部分的自然移动以外,由于需要较少的合缝,因此瓣环成形术带比瓣环成形术环可以更快地植入。在US5824066和WO2000/74603中示出了瓣环成形术带的实例。尽管可行,但是瓣环成形术带存在其它问题。例如,如果将瓣环成形术带仅锚定在脆性瓣膜环组织中,则所担心的是瓣环成形术带可能相对于瓣膜环过分地枢转。此外,现有技术的瓣环成形术带的轮廓(例如厚度)理论上足够大,以致于限定或妨碍血液流动。
此外,从US7371259可知,瓣环成形术带适于给瓣膜环提供加强的附接,并且已知方便其植入的保持件和分选件。
在瓣环成形术假体领域,众所周知的是需要瓣环成形术环或瓣环成形术带的持久结果,任何类型的瓣环成形术环消除环形移动,并且内三角距离不会改变。
鞍:主动脉-二尖瓣交汇处
在发生心脏收缩的环形收缩期间,使得瓣膜口狭窄,合缝区域被下拉以加重前二尖瓣鞍以及容纳膨胀的根部(Adams and coll.Curr.Cardiology Reports2008;10:226-32)。
大动脉和二尖瓣环形区域具有联系的相互动作:大动脉面积扩张可以方便二尖瓣面积扩张,并且反之亦然(Veronesi and coll.Circ Cardiovasc Imaging 2009;2:24-31)。
在心脏周期过程中两个瓣膜之间的角度改变,以当两个瓣膜环朝向彼此移动时,将支撑纤维连续性的作用作为锚锢点(Veronesi and coll.Circ CardiovascImaging 2009;2:24-31)。
瓣膜环心脏收缩动力学基本上是:
-中隔-侧距离=-23%
-合缝处-合缝处距离=-12%
-内-三角距离=+11%
鞍状的重要性是基于多个优点:保持瓣叶曲率致使瓣叶应力和弦应力减小(Ryan et al.e Ann Thorac Surg 2008;86:749-760);减小前瓣叶上的应力(JimenezJTCVS 2007;134:1562-8;Jensen Circulation 2008;118:S250-55);减小两个瓣叶上的应力(Salgo et al.Circulation 2002;106:711-7)。
出于全部这些原因,因为更加正常的生理学将使瓣膜成形术的手术更持久和有效,所以在手术后保持或再建立正常的鞍状是重要的。
本发明大体上涉及用于具有鞍状的二尖瓣成形术的改进的瓣环成形术带,由此获得了敞开的带与所述鞍状的优点。
附图说明
仅通过非限定实例,参照示出了本发明的优选实施方式的附图,基于下面的详细描述将获得对本发明的更好的理解。
在附图中:
图1是根据本发明的具有鞍状的敞开的带的3D视图。
具体实施方式
敞开的带的优点
敞开的带的使用很重要以便:避免前瓣叶折叠或变形;避免不必要的缝合位置;对于弦布置为外科医生留有足够的空间。
更具体地说,在MICS(微创方法)情形中避免不必要的缝合位置是非常有利的,因为其减小了瓣叶撕裂以及干扰主动脉根的风险(参照下面的再植入术)。
此外,需要指出的是开放环是快速、有效、更宽大(没有折痕、没有撕裂、没有变形)的,并且具有较大的口面积。
在另一个方面,公认的是敞开的带如何能够实现闭合环的全部功能,并且特别地:
已知半刚性带(或敞开环)恢复环形几何形状,即恢复D-形状(Redmond etal.J Heart valve Dis 2008;17:115-8);
不妨碍鞍的前部运动(Redmond J Heart valve Dis 2008;17:115-8.Timek et al.Ann Thorac Surg 2001;72:966-74)。
敞开的带的植入提供了持久的结果(Salvador et al.J Thorac Cardiovsc Surg2008;135:1280-1287.)
具有鞍状的全环的作用
本着重构鞍状的目的设计出具有鞍状的全环。然而这种环的的缺点在于所述鞍状在心脏收缩中和在心脏舒张中都是固定的,并且在心脏周期期间其形状不会改变。此外,全环的使用使得二尖瓣的前部像瓣膜环的其它部分一样随着时间硬化。具体地说,环的这个部分还干扰主动脉的基部。事实上已经报道在再植入过程中(用于替换主动脉根的程序),由于二尖瓣环使右侧和非冠状主动脉瓣尖点变形,所以有必要移除二尖瓣环(Redmond和coll.讨论中的莫尔)。
鞍状和敞开的带
对于鞍状和敞开的带来说,应该指出在植入斯格罗夫带(Cosgrove band)以后鞍状便恢复(Timek et al.Ann Thorac Surg 2001;72:966-74);鞍状实际上是环形高度与C-C(合缝处-合缝处)宽度之间的比率。当C-C恢复时,该比率将明显增加。此外,已经证明在心脏周期过程中仅部分环保持前部环形弯曲(Dagum et al.JTCVS 2001;122:665-73)。实际上其保持前部MA(二尖瓣角)提升和前后MA弯曲。
目前,用于瓣修复的已知的装置是全环(有或者没有鞍状)或平坦的敞开的带。存在两种类型的敞开的带:一种仅在植入以后呈现它们的形状(完全柔软不具有任何刚性)并且另一种(未来-带)是半刚性且平坦的。
用于心瓣膜修复的已知装置具有多个缺点,其中已经描述了闭合环(具有或不具有鞍状)但是基本地涉及它们与二尖瓣的前部的干扰,所述干扰在心脏周期过程中不能保持其移动并且负面地影响主动脉根的生理性移动。关于现有的敞开的带,它们:
i.不具有鞍状(前或后)
ii.不存在与合缝处相应的标记部分以及与三角相应的另一个标记部分
iii.在它们端部处的不存在曲率或者曲率太锐利。
根据本发明,提供了一种如图1中示意性示出的由敞开鞍1(由于生理学上具有“C”的形状,此后还表示为“理疗-C(Physio-C)”)构成的装置。
有利地,理疗C或敞开鞍1具有用于增加尺寸的优化形状(从D形到与称作“理疗II”的装置类似的更圆的圆形)以及在合缝处的优化曲率。
此外,根据本发明的装置是半刚性的并且在三角处具有初始鞍状,从而获得用于三角(LT和RT)处和用于合缝(LC和RC)处的清楚的定位。
本发明的特有特征在于所述鞍状设置到前侧和后侧。
敞开鞍1的“C”形的两个端部是圆形的,并且随着装置尺寸的增加,其通常的形状从更椭圆的形状改变到更圆形的形状:换句话说,当尺寸增加时,那么前-后直径逐渐地增加到大于侧-侧直径。
与已知的理疗II不同,
-其不固定主动脉-二尖瓣交汇处
-其允许鞍的周期性移动
-其允许鞍可能的后部位移。
因此,本发明的敞开的鞍1保持鞍但是不会将其固定在心脏收缩中:因此,其结合了敞开的带与鞍环的优点。
尽管已知的斯格罗夫-爱德华兹(Cosgrove-Edwards)瓣环成形术是完全柔软的,但是具有根据本发明的鞍状的敞开的带包括保持所述弯曲(鞍状)形状的内硬化元件。
Claims (5)
1.一种修复心瓣膜的装置,其特征在于,所述装置由半刚性敞开的带(1)构成,所述半刚性敞开的带(1)包括护套和布置在所述护套内大体上弯曲的硬化半刚性元件,所述硬化半刚性元件从邻近前-侧三角的第一端延伸到邻近后-中三角的第二端,用以限定非平面(非共面)复合C-曲线形状,以便在前侧和后侧模仿鞍状。
2.根据权利要求1所述的装置,其中所述敞开的带的C-状的两个端部是圆形的;由此获得用于三角(左三角,LT;右三角,RT)以及合缝处(左合缝处,LC;右合缝处,RC)的清楚的定位。
3.根据权利上述权利要求所述的装置,其特征在于,随着所述装置尺寸的增加,其通常的形状从更椭圆的形状改变到更圆形的形状的事实。
4.根据上述权利要求所述的装置,其特征在于,其在三角处具有初始的鞍状。
5.根据上述权利要求所述的装置,其特征在于,在所述护套内设置识别合缝处和三角的标注器。
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PCT/IT2010/000347 WO2012017455A1 (en) | 2010-08-02 | 2010-08-02 | Annuloplasty band for a simplified approach to mitral valvuloplasty for degenerative diseases |
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US (1) | US20130150958A1 (zh) |
EP (1) | EP2600797A1 (zh) |
CN (1) | CN103153231A (zh) |
CA (1) | CA2810301A1 (zh) |
WO (1) | WO2012017455A1 (zh) |
Cited By (1)
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CN107847319A (zh) * | 2015-06-09 | 2018-03-27 | 爱德华兹生命科学有限责任公司 | 不对称的二尖瓣瓣环成形带 |
Families Citing this family (3)
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AU2007254929A1 (en) * | 2006-06-02 | 2007-12-13 | Medtronic, Inc. | Annuloplasty ring and method |
US7993395B2 (en) * | 2008-01-25 | 2011-08-09 | Medtronic, Inc. | Set of annuloplasty devices with varying anterior-posterior ratios and related methods |
EP3013262B1 (en) * | 2013-06-26 | 2020-04-22 | Strait Access Technologies Holdings (PTY) LTD | Orientation device for use in mitral valve repair |
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- 2010-08-02 EP EP10763461.0A patent/EP2600797A1/en not_active Withdrawn
- 2010-08-02 CA CA2810301A patent/CA2810301A1/en not_active Abandoned
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CN111529132A (zh) * | 2015-06-09 | 2020-08-14 | 爱德华兹生命科学有限责任公司 | 不对称的二尖瓣瓣环成形带 |
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Also Published As
Publication number | Publication date |
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CA2810301A1 (en) | 2012-02-09 |
EP2600797A1 (en) | 2013-06-12 |
WO2012017455A1 (en) | 2012-02-09 |
US20130150958A1 (en) | 2013-06-13 |
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