CN1897893A - 人工瓣膜装置,特别是用于心脏的人工瓣膜装置 - Google Patents
人工瓣膜装置,特别是用于心脏的人工瓣膜装置 Download PDFInfo
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Abstract
一种人工瓣膜装置(10),特别是用于心脏的人工瓣膜装置。该装置(10)包括固定在缝合环(30)之上的人工瓣膜(20)。该装置(10)进一步提供了通过多个磁铁(21d,30b)固定于缝合环(30)之上的人工瓣膜(20),磁铁在两组件间提供吸力。
Description
技术领域
本发明总体上涉及医疗人工装置领域,具体地说,总体上涉及一种能够被植入人或哺乳动物的机体区域内的人工瓣膜装置。
背景技术
本发明的范围属于医学领域,且尤其属于心外科手术领域,其旨在对先天或后天瓣膜疾病的治疗,对于这些疾病,据指示需用人工瓣膜替换由于不同病因的病理过程不可逆地损伤的一或多个天然心脏瓣膜。
用人工瓣膜替换一或多个心脏瓣膜是长期以来被普遍接受的一种方法。该种外科治疗方法通常需要使用体外血液循环,其能够实现在心脏停跳且处于无血状态时对心腔的进入。
但是,尽管心外科领域发展非常快,可以说这类手术依然无法避免可能的一些可引发手术患者的疾病甚至死亡的并发症。
按照通常的分类,目前有主要两类的心脏瓣膜的人工替换物是临床可使用的:
(1)机械人工瓣膜;和
(2)生物人工瓣膜。
专业科学文献详细描述了人工瓣膜的种类,选择的有关说明,植入的外科技术,可能的并发症及结果。
然而,为了理解本发明所包含的主题及其创新之处,提供关于本领域状态的简短介绍似乎是有用的。
在第一类的机械人工瓣膜中,从中通过的血流由一或多个阀门控制,这些阀门由金属刚体组成,这些刚体以一定的方式组装由此能够在相应的刚性金属支撑环上周期性摆动。
相反,在第二种情形,即生物人工瓣膜(所谓“生物瓣膜”)中,血流是由装配在刚性支撑上的生物组织形成的条带控制的。
在生物瓣膜中,使用的组织通常是动物性来源的(牛心包膜或猪心瓣膜的天然条带),这些组织经预防性的化学处理使之成为免疫学惰性的且结构稳定的。
在用于心脏瓣膜构建的生物组织中,一种从金枪鱼角膜基质中提取的新的生物材料最近得到有益地推介,其目的在与降低或消除生物瓣膜随时间结构老化的可能性。
在所有情形下(机械或生物装置),包括了作为瓣膜装置的结构组件的一组件(所谓的“缝合环”),该组件装配在瓣膜装置基座的外周边缘,以缝合的方式将人工瓣膜安装并固定在取代先前被切除的天然瓣膜的同位瓣膜位置。
不言自明,该位于人工瓣膜装置基座外周边缘的缝合环的存在大大减少了瓣膜孔有效面积。
此外,很明显的,生物条带的支撑物(所谓“瓣膜支架”或简称“支架”)也大大限制了瓣膜的血动力学流动(haemodynamicdisengagement),造成人工瓣膜开口的有用面积的减少。
为使生物人工瓣膜装置在解剖学上更类似于天然心脏瓣膜,并提高其血动力学流动,很多结构上的改进被陆续采用,产生了没有支撑物的生物人工瓣膜亚型(所谓的“无支架瓣膜”)且该亚型的缝合环位于瓣膜基部水平而不是瓣膜外周边缘水平。
诸等改进使该种生物人工心脏瓣膜比起传统有支撑物的人工生物瓣膜具有更大的瓣膜孔有效面积。然而,应用此种无支撑物的生物瓣膜尽管有显著的血液动力学好处,植入该型人工瓣膜却比有支撑物且缝合环位于支架外周边缘的传统生物人工瓣膜更困难。
这一缺陷特别反映在:手术中心脏停搏及使用体外血液循环的时间需要增长和将人工瓣膜误植在靠近植入点的重要结构上的机率增加。
生物人工瓣膜普遍具有,无支撑物的人工瓣膜尤为明显的另一缺陷是:由于没有任何装置可以使人工瓣膜在缝合环上转动,原位定向(即植入后)无法实现。
此缺陷反映在:手术中在将瓣膜环缝合在解剖植入位点之前,人工瓣膜装置的正确定向是绝对不可或缺的。
在人工瓣膜随时间的耐久性方面,由于构建物质(如镀以热解碳的金属合金)的特性,可以说机械人工瓣膜的使用寿命事实上是没有限制的。
但是,机械人工瓣膜同时也有不利之处:术后患者必须终生服用抗血凝和抗血小板聚集药物来防止非常严重甚至致命的由于血液和金属人工瓣膜物质接触而造成的局部血栓栓塞。
生物人工瓣膜虽无需患者服用抗血凝药,其使用寿命却有限(从对年轻患者的几年到年老患者的最长15年),因为在瓣膜条带上的钙沉积的形成能导致结构故障。
生物人工瓣膜随时间的渐进性损坏使得要动新的手术用另一人工瓣膜替换原人工瓣膜,从而带来了手术患者的致病或死亡的相当大的手术风险。
事实上,心脏外科中对同一患者每隔一段时间实施多次介入以替代损坏了的生物人工瓣膜并非罕见。
因此,运用传统的生物人工瓣膜时经常遇到的问题可归纳如下:
—有限的使用寿命,随后需要更换人工瓣膜;
—瓣膜孔的有效面积(血流通过的有用面积)受到人工瓣膜外部的外周缝合环的存在的限制;
—一旦人工瓣膜被缝合在相应的解剖学结构上之后,就无法依靠转动来调节瓣膜的定向;且
—无支撑物的生物人工瓣膜特别考验植入技巧,需要手术者特殊的技艺。
因此本发明的目的在于克服与目前存在且临床上得到应用的人工心脏瓣膜相关的重要问题。
而且,根据本发明的主要方面,通过本发明引入的结构改造使得植入手术操作更简单,更精确,也更安全。
发明内容
本发明涉及当前的生物学具体实施方式中的心脏人工瓣膜,但并不从概念上排除依照权利要求书中要求的特征限定的机械人工瓣膜的构造。
因此,本发明的具体特征是提供组合式人工瓣膜装置,特别是用于心脏的人工瓣膜装置,其各结构部件通过磁力以可拆装的方式装配在一起,其具有显而易见的好处。
作为非限定性实施例,以下说明了生物人工瓣膜的可能的具体实施方式,尽管该构思可以被延伸到任何类型的人工瓣膜上。
附图说明
本发明将参照附图进行详细说明,附图单纯地作为非限定性实施例说明和提供具体实施方式,其中:
图1显示了本发明的人工瓣膜装置,特别是用于心脏的人工瓣膜装置的三维立体图;在立体图中,该装置以其“封闭”形式呈现。
图2显示了作为图1装置一部分的缝合环。
图3显示了同样是图1装置一部分的支架的三维立体图。
具体实施方式
为了更好地理解本发明详细说明中使用的术语,简短释义提供如下。
生物人工瓣膜:心脏瓣膜的替代物,其局部或整体由生物来源的物质(通常为动物来源)制成。生物人工瓣膜最重要的结构组件为生物材料(牛心包膜或猪心瓣膜条带)制成的“瓣膜条带”和塑胶材料制成的“支撑结构”(即所谓“支架”);该“支撑结构”(支架)不存在于所谓的无支架人工瓣膜中(无支撑)。
缝合环:它是由合成材料制成的环。
在传统的和已知的人工心脏瓣膜装置中所有这些组件(“瓣膜条带”、“支架”、“缝合环”)在它们的制造中以一定的方式被装配由此形成单一个体,且没有可能在随后的步骤中将这些组件彼此分开而不对该装置发生不可逆的破坏,使得装置无法用于植入目的。
如附图所示,人工瓣膜装置10包括人工瓣膜20和缝合环30。
依次地,人工瓣膜20首先包括支撑结构(支架)21,该支架由在生物人工瓣膜的构建中普遍使用的支架衍生而来。支架21由刚性的或优选地由微弹性的塑胶物质制成。此外,支架21可由任何其它生物相容材料(钢,钛等等)制成。
如具体在图3所示,支架21包括环状部分21a和三个突出部分21b,它们彼此有利地相互间隔120°排列。所述突出部分21b与环状部分21a为一整体。在环状部分21a底部壁上,连续凹槽21c由机械方法制成;所述凹槽21c能够容纳多个彼此间平行置放的永久磁铁21d。
在没有在此呈现的具体实施方式中,取代多个永久磁铁21d,可以提供环状或其他形状的单个永久磁铁。
在此说明的具体实施方式中使用的永久磁铁21d属于具有强吸力的一类磁铁(钕-铁-硼),且镀以一种可防止磁铁随时间氧化的物质(环氧树脂或其它)。多个磁铁的极性沿支架21的整个基底均匀排列,以这样的方式排列以对置于缝合环30上的对应结构产生均一的吸力,该结构将在以下说明。
支架21的基底形状为沿平面轴形成的圆周。在未在此呈现的其它具体实施方式中,承载磁铁21d的支架21的环状部分21a的几何形状及轴可以有所变化。
在目前的具体实施方式中,缝合环30与支架21的环状部分21a的内外径恰相吻合。这是通过沿横轴切割支架21本身的环状部分21a实现的。同样在此例中,如图2中具体所示,凹槽30a通过机械方法获得;为了容纳彼此平行排列的类似的多个磁铁30b且以一定方式定向极性以磁性地吸引置于支架21环状部分21a中的磁铁21d,凹槽30a具有与支架21的环状部分21a中得到的凹槽21c完全相同的尺寸。
此外,缝合环30被涂以合成组织50用于将缝合环30缝合至心脏内解剖学结构(瓣膜环面)(未显示)。
图1所示人工瓣膜20有3个瓣膜条带40,这些条带可由生物或合成来源的任何材料制成。
所述瓣膜条带40可用不同方法装配到支架21上,通常是在制作时用手工缝制的方式。瓣膜条带40亦可装在支架21中,或作为“覆”于支架21外的整体结构的一部分。
有利地,为获得瓣膜条带40,可以使用鱼特别是金枪鱼的角膜基质。
支架21的环状部分21a和缝合环30的表面均优选以一定方式涂以一定厚度的合成组织50,该厚度不影响或不降低磁性吸力,且该方式不会在由人工瓣膜20和缝合环30组成的装置10的两组件之间的随后的磁力耦合过程中制造干扰。
具体地说,置于缝合环30上的合成组织50会向外延伸一小部分以便使其更容易缝合在心脏内结构上(未显示)。
作为实施例,下面将说明在大动脉瓣膜置换中装配两个主要组件即人工瓣膜20和缝合环30的标准方式。对于本领域技术人员而言显而易见的是,相同的教导可被用于体内的任何管状结构特别是任何心脏瓣膜(大动脉瓣,二尖瓣,三尖瓣,肺动脉瓣)。
手术通常以胸骨正中切开方式进行,但其他心脏进入方式如侧面胸廓切开或其它已知的方式也是可行的。在把导管插入心血管结构实施体外血循环之后,通过灌流心脏冷冻液使心脏停止跳动。
在心脏停跳和缺血状态下,上行大动脉被横向切开至足够的范围以充分看到大动脉瓣膜和大动脉环面(外周环状解剖学部分,在该处三个大动脉瓣膜条带被固定在左心室和大动脉起始处之间的转换点)。将位于瓣膜环面嵌入部分的(病变)瓣膜条带切除后,用适当工具(定径机)精确测量瓣膜环面的准确直径已选定具有匹配直径的人工瓣膜装置10。
接下来的特别是与本发明相关的过程包括用手术线将装置10的磁性缝合环30(组件号1)缝于大动脉瓣膜环面。此过程中,需特别注意将缝合环30含磁铁一面朝向远离心脏一侧,以便接下来能够磁性吸引人工瓣膜20(组件号2)。
对于本领域技术人员而言显而易见的是,将缝合环30缝于大动脉瓣膜环面的手术时间远比根据现有技术将整个人工瓣膜装置缝于环面的传统技术更简便也更快捷。同样磁性的人工瓣膜20(组件号2)随后靠近此前已被固定于环面的缝合环30(组件号1),如所述的,由于分别沿具有相同直径的组件号1和组件号2的整个圆周正确定向的磁铁21d及30b的存在,引起相互磁性吸引产生。
通过磁力的耦合因此是即时的、安全的,在两组件号1和2间没有干扰,两组件耦合且彼此直径一致。如此装配的该组合式人工瓣膜装置具有优点:组件号2具有在原位相对于组件号1(已被固定)调节定向的能力。这种调节定向可在所述组件之间不丧失磁性接触的状况下,通过施加轻微的力引发组件号2沿相同轴在组件号1上的滑动来完成。对大动脉流和邻近冠状动脉口的最优灌流而言,人工瓣膜20(组件号2)相对于缝合环30(组件号1)的原位转动的可能性对正确定向是特别有益的。此外,装置10没有位于支架基部外周的缝合环,使得人工瓣膜的植入比起传统装置拥有更大的有效直径,具有植入的血液动力学性能的明显优势。
在可替换的具体实施方式中(在此未显示),人工瓣膜装置可通过导管植入,即无需采用传统的心脏外科手术。
在该可替换的具体实施方式中,如以上已说明的具体实施方式中一样,人工瓣膜装置包括两主要组件(组件号1和组件号2),即人工瓣膜(组件号2)和缝合环(组件号1)。
在此例中,人工瓣膜(组件号2)的基部不再是如以上所述的具体实施方式中的其中插入磁铁的刚性结构,而是将磁铁缝入生物组织基部,从而可能暂时性减小人工瓣膜基部的直径使其可被插入直径比人工瓣膜的原始直径小的导管。
此例中的缝合环(组件号1)亦非刚性的,而是将磁铁装在同样薄且易变形的合成材料(聚酯)中。
因此,在该例中,同样可能同时减小缝合环的直径使其能被插入直径比缝合环的原始直径适当小的导管。
操作中,通过压缩两磁性组件号1和2被同时减小尺寸并被次第插入合适的导管。在不变的血管造影术的控制下,携带组件号1和2的导管插入外周动脉或静脉(例如股动脉或股静脉)。
一旦到达心脏(特别是植入位置、大动脉瓣、肺动脉瓣、二尖瓣、三尖瓣),缝合环被释放并膨胀(导管系统内包括气囊),直至呈现原始直径。所述缝合环被固定在植入点(瓣膜环面)。
由于位于组件号1的外周的钩的存在,可以促进该磁性缝合环的固定。
紧接着,真正的人工瓣膜被释放,并同样伴随导管气囊该装置膨胀直至恢复其原始直径,该直径与缝合环的直径精确匹配。通过磁性吸引,两组件号1和2一定方式耦合,该方式与结合第一具体实施方式说明的方式精确相似,如所述,该方式中使用了传统的手术技术。
总而言之,本发明人工瓣膜装置的优势如下:
(a)可通过极为简便、快捷和可靠的技术将其植入;
(b)当需要时其可被更换,其具有特别简化的手术过程、短的手术时间和降低的患者风险;
(c)其可被以极简单和无创伤的方式(在植入后)原位旋以得到正确的解剖学定向;
(d)其比现有的人工瓣膜具有更好的血液动力学性能(源于更大的瓣膜孔有效面积);
(e)无需将缝合环(组件号1)从天然瓣膜环面上切下,更换人工瓣膜的能力(特别地,组件号2,其上的瓣膜条带40通常会结构损坏);将组件号1留于原位更换组件号2,施加与两组件的磁性吸引相反的力足以导致两者的分离(拆分);很明显,比起通过非常简单和非常快捷的磁性吸引方式从组件号1上仅仅更换组件号2,将人工瓣膜缝合环从心脏上的切下和新的人工瓣膜的缝合所必须的手术过程造成更长的时间,更大的风险和错误的可能性。
(f)使用导管插入植入人工瓣膜的介入的实施为手术患者带来了相当的好处;所述植入技术无需采用胸骨正中切开或胸廓切开的方法以对心脏的手术进入,也无需切开心腔,因此无需提供实现体外循环的植入;进一步的,导管植入的另一明显好处在于其较传统方法确保了更快的恢复时间。
Claims (14)
1.一种人工瓣膜装置,特别是用于心脏的人工瓣膜装置,装置(10),其包括装在缝合环(30)上的人工瓣膜(20);其特征在于所述人工瓣膜(20)通过磁性装置(21d,30b)固定在所述缝合环(30)上。
2.根据权利要求1所述的人工瓣膜装置(10),其特征在于所述磁性装置(21d,30b)包含于各自的连续凹槽(21c,30a)中,所述凹槽分别在所述人工瓣膜(20)和所述缝合环(30)上得到。
3.根据权利要求2所述的装置(10),其特征在于至少一部分所述磁性装置(21d)包含于在支架(21)中得到的连续凹槽(21c,30a)内,该支架为所述人工瓣膜(20)的一部分。
4.根据权利要求2或3所述的装置(10),其特征在于所述磁性装置(21d,30b)包括多个磁铁(21d,30b)。
5.根据权利要求2或3所述的装置(10),其特征在于所述磁性装置(21d,30b)包括环状磁铁。
6.根据以上权利要求中任意一项所述的装置(10),其特征在于所述人工瓣膜(20)包括支架(21)和瓣膜条带(40)。
7.根据权利要求6所述的装置(10),其特征在于所述瓣膜条带(40)由生物材料制成。
8.根据权利要求7所述的装置(10),其特征在于所述生物材料来自角膜基质,特别是来自金枪鱼的角膜基质。
9.根据以上权利要求中任意一项所述的装置(10),其特征在于至少一部分所述人工瓣膜(20)和至少一部分所述缝合环(30)涂以合成组织(50),该组织能够促进所述人工瓣膜(20)和所述缝合环(30)的缝合。
10.根据权利要求1所述的装置(10),其特征在于所述人工瓣膜和所述缝合环由可变形材料制成由此使它们通过导管插入患者体内,即无需采用传统的心脏外科手术。
11.根据权利要求10所述的装置(10),其特征在于磁铁埋在所述可变形材料中。
12.根据权利要求10或11所述的装置(10),其特征在于缝合环由合成材料,特别是聚酯制成。
13.根据权利要求10,11或12所述的装置(10),其特征在于缝合环带有多个钩,该钩能够促进缝合环固定在植入位点中。
14.一种在人体中植入人工瓣膜装置的系统,该装置包括易压缩变形的磁性人工瓣膜和磁性缝合环;所述植入系统包括以下步骤:
(a)通过压缩暂时性减小磁性人工瓣膜(组件号2)和磁性缝合环(组件号1)的尺寸,以这样的方式实现它们在导管中的插入,该导管能够将所述组件号1和组件号2运送至植入位点;
(b)在稳定血管造影术控制下,将携带所述组件号1和2的所述导管插入外周静脉或动脉;
(c)一旦达到植入位点,释放缝合环,该缝合环膨胀直至呈现原始尺寸;
(d)将所述缝合环固定在植入点;
(e)一旦达到植入位点,释放人工瓣膜,该人工瓣膜膨胀直至呈现原始尺寸;和
(f)将所述的人工瓣膜磁性地固定于所述缝合环上。
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2003
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-
2004
- 2004-10-21 US US10/576,483 patent/US20070255400A1/en not_active Abandoned
- 2004-10-21 AT AT04769710T patent/ATE477771T1/de not_active IP Right Cessation
- 2004-10-21 ES ES04769710T patent/ES2353016T3/es active Active
- 2004-10-21 DE DE602004028749T patent/DE602004028749D1/de active Active
- 2004-10-21 CN CNA2004800388098A patent/CN1897893A/zh active Pending
- 2004-10-21 BR BRPI0415839-3A patent/BRPI0415839A/pt not_active IP Right Cessation
- 2004-10-21 EP EP04769710A patent/EP1682047B1/en not_active Not-in-force
- 2004-10-21 WO PCT/IB2004/003480 patent/WO2005039452A1/en active Application Filing
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CN105142574A (zh) * | 2013-03-15 | 2015-12-09 | 爱德华兹生命科学公司 | 带瓣主动脉管道 |
CN103705315A (zh) * | 2013-12-12 | 2014-04-09 | 宁波健世生物科技有限公司 | 防止瓣周漏的主动脉瓣膜支架 |
CN108992209A (zh) * | 2015-11-06 | 2018-12-14 | 麦克尔有限公司 | 二尖瓣假体 |
US11207177B2 (en) | 2015-11-06 | 2021-12-28 | Micor Limited | Mitral valve prosthesis implantation |
US11304799B2 (en) | 2015-11-06 | 2022-04-19 | Micor Limited | Mitral valve prosthesis |
CN114082001A (zh) * | 2021-10-27 | 2022-02-25 | 浙江清华柔性电子技术研究院 | 植入式液体转运装置及液体转运控制系统 |
CN114082001B (zh) * | 2021-10-27 | 2024-03-26 | 浙江清华柔性电子技术研究院 | 植入式液体转运装置及液体转运控制系统 |
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WO2005039452A1 (en) | 2005-05-06 |
ATE477771T1 (de) | 2010-09-15 |
BRPI0415839A (pt) | 2007-01-02 |
ITBO20030631A1 (it) | 2005-04-24 |
EP1682047A1 (en) | 2006-07-26 |
EP1682047B1 (en) | 2010-08-18 |
US20070255400A1 (en) | 2007-11-01 |
ES2353016T3 (es) | 2011-02-24 |
DE602004028749D1 (de) | 2010-09-30 |
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