CN1422139A - 用于心脏病治疗和矫正的心室内部装置 - Google Patents

用于心脏病治疗和矫正的心室内部装置 Download PDF

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CN1422139A
CN1422139A CN01807988A CN01807988A CN1422139A CN 1422139 A CN1422139 A CN 1422139A CN 01807988 A CN01807988 A CN 01807988A CN 01807988 A CN01807988 A CN 01807988A CN 1422139 A CN1422139 A CN 1422139A
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法拉兹保罗
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Cube S. R. L.
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Abstract

本发明包括一种装置,致力于优化患有心力衰竭病人的心脏几何结构。上述装置包括在朝着心室内部的径向方向上有一个或多个弹性元件,在上述心室的横向方向上发生塑性变形,上述元件还带有将其连接到心室内壁上的装置。

Description

用于心脏病治疗和矫正的心室内部装置
技术领域
本发明涉及一种治疗心力衰竭的病人的心室内部装置,上述心力衰竭可能由于不同的病因(自发性,局部缺血,瓣膜)产生,并伴有连续机能障碍和/或带有二尖瓣缺损的左心室膨胀;本发明还涉及一种可以优化心脏病困扰的心脏舒张和收缩活动。本发明尤其还致力于一种心室内部装置,对于伴有环状膨胀的二尖瓣缺损引发的心脏病和其它类型的心脏病,可以重建环状组织尺寸而不需要去除任何心脏质量,并且如果不能够实施上述技术的话,它还能够优化心脏几何结构,作为一种可替换的移植和/或机械心室的辅助手段。
本发明的潜在问题
心力衰竭是由于心脏,尤其是心肌组织的机能障碍导致的。其副作用就是向生命器官的供血不足。这种心血循环的不足就会更加恶化病人的病情。
心力衰竭的心脏病人有着各不相同的病因(器官疾病,自发性,心脏病,瓣膜疾病,局部缺血和同性疾病)。
心脏病会导致心脏及其腔室膨胀,降低心脏收缩功能(喷射次数),减少心脏输出,增加左心室壁压力,以及持续增加心脏末端舒张压力。
在过去的二十年中,心脏学和心脏外科(也许更多其它的专门学科)都获得了令人瞩目的诊断和治疗成果。在很多发展中国家,都明显延长了预期的平均寿命;这些进步都很大的改变了心血管疾病的治愈程度。而作为本发明的目的,平均寿命的延长却使患有心力衰竭病人的数量增加,而且目前只能部分被治愈。心力衰竭的一个特点就是左心室心脏舒张和收缩功能的退化;而对应这种血液动力变化的机械组织结构目前还并不完全被人们所知。这只能部分地归结于恶性循环,也就是对应于保持体内平衡(左心室的肥大和补偿膨胀,增加了血管紧张素和交感神经系统活动)的生理组织加速了这种心室的机能障碍。
无论什么病因导致的机能障碍,都认为这些补偿系统会导致心脏细胞收缩性的机能障碍将进一步恶化和/或退化加速以及自身细胞的损失。
对于左心室的机能障碍,不管什么病因,都会产生心脏结构的变化以及心脏几何形状的连续变形。
左心室除了生理椭圆形的形状都会导致机械负作用,结果侧壁的张力增加,从而引发机械组织进一步变化,达不到预期效果。
左心室的进一步膨胀使病人会从表面毫无症状的心脏机能不良恶化到慢性心力衰竭。
对于上述方法,心力衰竭是一种发展迅速的流行病学问题:这也是对于超过65岁的病人最普遍的诊断方法,而在美国第四普遍的原因是住院治疗;而且其并发症状实际上也会产生经济上的影响。
直到几年前,传统的外科(也就是冠状动脉旁路嫁接和瓣膜置换)对于心肌不良的病人还是禁忌的。在这种情况下,心脏移植被认为是一种有效的介入手段。
但是,心脏移植的应用由于捐赠人数量很少(只有10%)而受到局限,而且还有很多绝对的禁忌要求。
技术描述
目前治疗心力衰竭提出了新的理论和方法。
一种流行的理念就是病人可以进行外科治疗来改善心脏功能,从而更有效的选择药物疗法。
对于环状膨胀的二尖瓣缺损,由于不同的瓣膜方法,适于环状包容的通常办法就是应用几种环圈,并都由非生理特性例如刚度,局部弹性来限定。
治疗患有局部缺血心脏疾病的心力衰竭最普遍的“介入”方法目前就是冠状动脉旁路嫁接(CABG)。
心脏机能不良的表现和慢性心力衰竭总是被认为是冠状外科的冒险因素。所以手术前评估和手术前治疗采取的一些新方法就会使由于上述“介入”造成的死亡大大减少。
通过诱发压力测试,根据改善的心脏功能,局部缺血或心肌生存力证明就有可能获得良好的外科血管再生结果。
在更严格界定为心室机能不良的情况下,解释瓣膜心脏疾病机能不良的相同新颖理念允许通过应用新的心肌保护方法和新的外科技术,使用外科方法来解决。
其中最引人注目的实例就是二尖瓣缺损,可以通过使用小弥补环的保守和补偿疗法来治疗。这种小弥补环能够减小较晚产生的环状组织和改善二尖瓣小叶的缩窄。
已经证明,心肌血管再生和瓣膜修补能够改善左心室的功能。
目前的技术努力通过针对减少或增加心室数量的心脏外科方法,主要集中在改进左心室的功能上。
在过去的几十年里,我们已经知道,伴有左心室动脉瘤的心力衰竭病情在左心室动脉瘤切除术之后能够大大得以改善。
这种理念目前已经应用在心室以及非运动区域的重构方面。
目前取得的丰富经验使心室的这种重构进展可以涉及到从线性修复动脉瘤到更复杂的针对排斥血管梗塞的和/或隔膜或自由侧壁的非运动区域。(Jatene-Dor procedure)
参照Laplace法则,动脉瘤切除术和梗塞去除术可以明显的显示出保持心室心肌层的恢复功能(侧壁压力=心室内压力×左心室半径/2×壁厚)。
Laplace的观点已经被Batista应用在和Chagas疾病一样的自发性膨胀心脏病或瓣膜病因性膨胀心脏病的治疗上。
Bolling认为应用限制环状装置是为了能够矫正经常发生膨胀的二尖瓣膜缺损以及根据Batista程序相同原则,能够改善机能不良心室的心脏功能。
使用治疗心力衰竭的外科程序(通过长期的实践和实验)仍然受到很大局限,结果也备受争论,而且也不能限定一个清楚的介入方法来治疗代谢失调的患者。
但是,可以从长期的结果或理论解释推知到目前为止长期实践中存在的技术缺陷。
为了增加心脏肌肉的可收缩能力,限定心脏舒张和减少心脏侧壁压力,已经提出了很多方法和装置。
专利申请WO9829041描述了一种针对通过减小侧壁压力来治疗代谢失调心脏的装置。
在其主要实施例中,装置包括有通过插入的连接铁条,其设计成可以牵引至少两个互相对着的心脏腔室;而且还描述了一种在心脏中定位上述装置的方法。
如下所述,对应于本发明,这种在前技术的不利之处在于在心外膜应用连接铁条会干涉到冠状动脉;而且,由于上述元件都是较大的销钉,会压缩侧壁之间的两点,所以它们会在直线的方向上减小心室部分的直径,但是却不减小上述部分的周长。
上述使用在前技术的装置的进一步不利之处就是它可能引起并发的混乱以及不可能很容易的和其它治疗所需的矫正措施相结合。
而且,连接铁条的刚性还可能影响心脏的舒张功能。
WO9814136公开了一种心脏肌肉外表面的X形网络和这种应用的方法。相对于本发明,该装置的缺点就是应用在心外膜上有可能影响到冠状动脉,以及和WO9829041情况一样会引起慢性心包炎。
而且,X形网络有着明显的固有缺点就是和这些心脏病患者相连的时候,会影响到心脏的舒张功能。
在文献US5192314中公开了一种插入到心室中的顶盖,但是上述盖子不能减小赤道直径,而且也不能达到储存优化了的心室几何结构的目的。
专利申请WO9944534描述了一种心外膜带,其缺点就是它们会影响心脏的舒张功能,而且和上述提及的文献中的连接铁条和X形网络一样还会产生更大量的压缩。
而且,上述带组成了一种静态装置,不可能存储优化的心室几何结构。
在专利申请WO9956655中涉及了一种左心室再成型的方法(外科方法,和Jatene和Dor叙述的外科方法相类似),这种方法使用了没有任何固有弹性的刚性材料。所以它也有着和上述提及文献以及外科方法相同的潜在缺点。
在专利申请WO9829041还描述了一种环,既不连在心室侧壁上,也不连在二尖瓣环状组织上,也就是具有足够的刚性来保持次二尖瓣装置只作为一种限制性装置。
在专利US5674280公开了一种瓣膜环状套环,其主要特点就是由低弹性金属合金制成,从而就不可能直接在心室上活动。
发明描述
本发明的目的就是建立一种装置来克服基于现有技术的上述装置的缺点。它包括一种有弹性的心内装置,通过减少心室二尖瓣环状组织和/或赤道的周长和/或顶端,被设计成可以减少直径以及心室内的体积。
这个弹性装置的特点就是径向可以弹性变形,轴向塑性变形。
上述结构的特点在从心脏收缩阶段到心脏舒张阶段,还有利于使心脏收缩功能和渐进增加的弹性的多重模块化。相对于对末端心脏的舒张压力,弹性的增加是非线性的,这样就防止了更大体积的压缩和可能产生的连续心脏舒张干扰。
本发明装置的进一步优点就是不需要减少心脏的质量。
其轴向弹性变形能力可以调节心内侧壁,从而修复左心室为原始形状。
通过本发明的弥补装置,就能够重建优化心脏腔室的几何结构使弥补材料和心脏侧壁上的侧壁压力再重新分布。
上述装置根据非线性规律,由设计的弹性来限定。
上述非线性弹性使本发明的装置在收缩阶段作为心脏收缩功能的一种帮助手段;就心脏舒张功能而言,和弹性件的非线性规律相同就意味着上述装置不会影响到心脏的舒张功能:实际上,尽管需要克服膨胀逐渐增加的阻力,就像WO9814136和WO9944534公开的装置那样,上述装置在生理限制内阻碍其膨胀,不会静态压缩心脏。
而且,上述装置和其它疾病所必需的心外膜和心脏内的治疗措施(二尖瓣膜切开术,二尖瓣膜置换,主动脉瓣置换,CABG等)相结合也成为可能,基于患者心室的功能,体积和几何特点,通过不同方法(不同的数量和大小)使用上述装置就有可能进行人格化修复心室。
附图叙述
通过附图能够更好的理解本发明装置的各个实施例。
图1是带有定位于不同位置的本发明装置的心室腔截面图;
图2所示的是装置的第一类型;
图3所示的是装置的第二类型;
图4所示的是装置的第三类型;
图5所示的是装置的第四类型;
图6所示的是装置的第五类型;
图7所示的是装置的第六类型;
图8所示的是装置的第七类型;
图9所示的是带有和轴向弹性件相连的本发明装置的心室腔截面图;
图10所示的是带有和轴向以及径向弹性件相连的本发明装置的心室腔截面图;
图11所示的带有盖子的本发明装置;
图12所示的带有盖子的另一类型本发明装置;
图13所示的带有盖子的另一类型本发明装置;
图14所示的是本发明装置的固定装置。
图1所示的是心室腔/左心室1,在其顶部可以看见主动脉9;本发明的装置插在心室腔1的心内膜2上。包括基本上椭圆形,圆形或不对称的装置6,7或8(参看图2-8),对于心内膜2内周长的不同部分3,4或5来说是可调的,数量上取决于机能不良心室的特性。
如果不修改本发明的功能,装置可以有不同的形状和不同的结构。为了分离心室的正常功能区域,它们同样可以是开放的或闭合的,分别如图2-8所示。
上述装置的大小取决于心室的尺寸和相同心室各部分的不同直径。
实际上,参看图1,装置6可以设置在相对于二尖瓣环3的直径上,或装置7可以设置在赤道直径4上,装置8可以设置在顶部半径5上。
参看图2,各个装置都可以有矩形实体截面,从中央可以看出来,而且如左侧图,也可以是一条开口带;如右侧图,也可以是一个封闭环。
参看图3,各个装置都可以有圆形实体截面,从中央可以看出来,而且如左侧图,也可以是一条开口带;如右侧图,也可以是一个封闭环。
参看图4,各个装置都可以有中空的波纹管圆形截面,从中央可以看出来,而且如左侧图,也可以是一条开口带;如右侧图,也可以是一个封闭环。
参看图5,各个装置都可以是由平面弹簧制成的开口或封闭带,可以是连续的,也可以是不连续的。
参看图6,各个装置都可以是由螺旋弹簧制成的开口或封闭带,可以是连续的,也可以是不连续的。
如上所述,在心室轴线的方向,上述装置都是塑性的(参见图7和8),在心室径向的方向,都是弹性的:由于上述装置的恢复能力,这就产生一个积极的心脏舒张膨胀。在心室内部压力下,使其径向膨胀到一个有益的范围,同时弹性势能的积累:在其最大负载点,上述装置返回到其静止尺寸,这样就可以由于其弹性力进行一个积极的心脏收缩过程。
上述装置的弹性并不是线性的,在心脏舒张阶段,它们必须保持对膨胀几乎没有任何阻力;材料的弹性必须以和心室内部压力相反的关系减小,这样就能够确保上述装置当其朝着最大直径扩张时,相对膨胀能够产生更大的阻力,这个阻力和末端心脏舒张压力最大值相同。具有弹性势能的上述装置就会在最大膨胀点反转运动方向并开始收缩:缝合心室内壁或者通过心肌侧壁,它就会施加一个径直向内的力作用在其自身侧壁上,这就会有助于心室的收缩(心脏收缩阶段)。
如图9所示的实施例,装置6,7和8通过弹性件10相连接,以便于产生沿着心室1轴线的有着预定强度的应力;上述应力可以是对称的,也可以是不对称的。弹性件10和装置6,7和8相连,或和心室1的侧壁相连。
参看图10,装置6,7和8可以通过弹性件10在它们周围不同的点相连,其径向和轴向元件被指定产生预定强度的力。
在优选的实施例中,参考图10,11,12和13,它们由护套或编织盖遮盖住的生物材料和不排斥材料构造成,这些护套或编织盖生物材料具有适于缝合的两个唇部或侧翼;构成上述编织盖的材料例如可以是自体固有的心包膜,或异体构造的心包膜,或一种市场上的非凝血生物不排斥材料(聚四氟乙烯,涤纶织物,硅树脂)。
本发明构造一种生物不排斥材料的装置是可能的,其通过沿着周长交替改变尺寸来完成,并部分缩小以便于适合直接缝合到心内膜上而并不需要护套。
应用上述装置的方法就是使用分离的缝针,缝合上述遮盖或护套的唇部,通过可能是U形的涤纶织物或其他上述的生物不排斥材料的加强件来加强。
使用这种方法,上述缝针不会和组成弥补装置的弹性以及柔性件相互干涉。
上述缝合过程必须彻底:也就是,对于每个装置分离缝针的两个外围缝合必须完成彻底,除非针脚已经透壁。
实施本发明的另一种方法就是垫式缝合,通过开口环/带穿过肌肉壁厚度和预定测量顶部的接头出来完成。
应用在弥补元件上的横向和纵向连接的缝合都有预定的弹性。
上述装置的任何元件都必须通过使用材料(金属弹簧)固有的不透辐射性或弹性材料内部额外的不透辐射元件或复盖材料来加以限定。
通过上述的装置,能够达到下列目的:
(a)增加喷射次数,也就意味着增加在末端心脏舒张量之间的比率,加大末端心脏舒张量和末端心脏收缩量的差别。
(b)通过保持自然环状的生理弹性来消除二尖瓣的缺损,
(c)通过使用上述装置内在的应力来帮助加强心脏收缩功能,
(d)可以预调的心脏扩张,
(e)上述装置和心脏功能的长期射线控制。
在相同创造理念的范围内,能够直接导出本发明装置可以有不同的形式和实施例。

Claims (24)

1、通过矫正左心室(1)的几何结构,而不需要去除心脏质量的一种治疗膨胀性心脏病的心室内部装置,其特征在于上述装置(6,7和8)包括至少一个形状和其施加在的心内部位周长基本相类似的元件,并在朝向心室内部的径向方向上易于弹性变形,在上述心室横向的方向上塑性变形,所述元件带有将其和心室内壁和/或二尖瓣环状组织相连的装置(12)。
2、根据权利要求1所述的装置,其特征在于,上述元件由生物材料或不排斥材料制成的编织盖遮盖住,上述编织盖具有一个平面构件和外部构件(12)突出于上述元件的两侧,上述两个构件通过编织盖的平面构件连接到心室(1)的内侧壁(2)和/或通过缝合连接到二尖瓣环状组织(3)上。
3、根据权利要求2所述的装置,其特征在于,构成上述编织盖的材料是聚四氟乙烯,涤纶织物或戈尔特克斯纤维。
4、根据权利要求2所述的装置,其特征在于,构成上述编织盖的生物材料是人或动物的心包膜。
5、根据权利要求1所述的装置,其特征在于,所述元件带有将其和心室(1)内壁和/或二尖瓣环状组织(3)相连的装置,所述装置包括至少一个沿着其表面横截面变窄区域,上述横截面变窄区域易于直接和上述心室内壁和/或二尖瓣环状组织缝合在一起。
6、根据前述权利要求所述的装置,其特征在于,上述元件包括有封闭或开口环。
7、根据前述权利要求所述的装置,其特征在于,上述元件的横截面为矩形,或圆形,或椭圆形,或半圆形,或半椭圆形。
8、根据前述权利要求所述的装置,其特征在于,上述元件包有封闭或开口带。
9、根据权利要求1-7所述的装置,其特征在于,其由线性带组成。
10、根据权利要求1-5所述的装置,其特征在于,其由封闭或开口的螺旋弹簧组成。
11、根据权利要求1-5所述的装置,其特征在于,其由封闭或开口的平面弹簧组成。
12、根据权利要求1所述的装置,其特征在于,上述弹性变形和心内压力为非线性关系。
13、根据权利要求12所述的装置,其特征在于,上述弹性变形当心内压力增加的时候减小。
14、根据权利要求13所述的装置,其特征在于,上述弹性变形可以连续限制心脏舒张膨胀。
15、根据权利要求2-5所述的装置,其特征在于,缝合针脚可以通过生物材料或不排斥材料的加强件来加强。
16、根据权利要求1所述的装置,其特征在于,上述装置包括不止一个用弹性件径向联接的元件。
17、根据权利要求1所述的装置,其特征在于,上述元件包括直接相连的弹性件(10)。
18、根据权利要求17所述的装置,其特征在于,其包括不止一个由弹性件(10)轴向联接的元件。
19、根据权利要求1所述的装置,其特征在于,上述元件带有能够穿过心肌侧壁的装置和其连接。
20、根据权利要求1所述的装置,其特征在于,装置(6,7和8)由垫式缝合来实现,通过开口环/带穿过肌肉壁厚度和预定测量顶部的接头处来完成。
21、根据权利要求1所述的装置,其特征在于,上述装置的任何元件都必须通过使用材料(金属弹簧)固有的不透辐射性或弹性材料内部额外的不透辐射元件或复盖材料来加以限定。
22、根据权利要求1所述的装置,其特征在于,上述装置能够在心脏收缩阶段释放弹性势能。
23、根据权利要求1所述的装置,其特征在于,上述装置设置有一个或多个沿着心室不同平面的径向弹性元件,以及横向变形的可以调节上述心室几何结构;对应于权利要求12,13和14,在心内压力的作用下,上述元件扩张。
24、根据权利要求1所述的装置,其特征在于,上述装置设置有不止一个径向弹性元件,由线性弹性件径向和/或轴向的连接;上述元件沿着心室不同平面而且横向变形的可以调节上述心室几何结构;对应于权利要求12,13和14,在心内压力的作用下,上述元件扩张,通过上述线性弹性件,分配心室侧壁的压力。
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