CN101052359A - 可植入的人工瓣膜 - Google Patents
可植入的人工瓣膜 Download PDFInfo
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Abstract
本发明提供了一种瓣膜假体,其适合于最初被压缩成适于通过体导管到达目标位置的插管术的狭窄构造,并适合于在目标位置展开。
Description
相关申请
本申请要求于2004年4月23日提交的美国临时申请第60/565,118号的优先权。
技术领域
本发明涉及可植入装置。更具体地说,本发明涉及用于心脏移植的心瓣膜假体装置。本发明还可以应用于其他体腔、血管或体管。
背景技术
人体中生命必需的流体输送主要是通过瓣膜调节。生理性瓣膜用来防止例如血液、淋巴液、尿液、胆汁等的体液的回流,由此保持身体的流体动力学单向性,进而获得合适的体内稳态。例如,静脉瓣维持血液向上流动,尤其从下肢回流到心脏,而淋巴管瓣防止淋巴管内,尤其是四肢的淋巴管内的淋巴液的回流。
由于它们的共同功能,尽管相对大小变化,但瓣膜共有某些解剖特点。心瓣膜是体内最大瓣膜之一,其直径可以超过30mm,而较小静脉的瓣膜可以具有不大于零点几毫米的直径。然而,与它们的大小无关,许多生理性瓣膜位于称为窦的特殊解剖结构。瓣膜窦可以描述为容纳瓣膜的血管壁内的扩张或膨胀。窦的几何结构在瓣膜的工作和流体动力学中起作用。一种功能是引导流体流动,以便产生涡流,该涡流防止瓣膜小叶在流速峰值时例如在心缩期粘附到血管壁上。窦几何结构的另一种功能是产生电流,其促进在回流压强开始时小叶的精确闭合。窦几何结构在降低下述压力方面也是重要的,即,在瓣膜小叶或尖打开和闭合时,由差分流体流动压力施加在其上的压力。
因此,例如,在天然主动脉根中的瓦尔萨尔瓦窦内出现的涡流,已经显示出在心缩期结束时在产生平滑的、逐渐的和平缓的主动脉瓣闭合方面的重要性。血液被容许沿窦的曲线轮廓运行并运行到瓣膜小叶上而影响它们的闭合,从而降低直接液流作用于瓣膜小叶的压力。瓦尔萨尔瓦窦还包含冠状口,其是供给心肌的动脉的流出开口。当瓣膜窦包含这些流出开口时,它们还起着在整个心动周期内向这些脉管提供血流的作用。
当瓣膜由于瓣膜疾病或损伤的结果而显示异常的解剖特征和功能时,它们用来调节的生理性流体的单向流动则被破坏,这导致增加的流体静力压。例如,静脉瓣膜异常导致血液回流和汇聚在小腿内,这导致疼痛、肿胀和水肿、肤色改变、以及极难治疗的皮肤溃疡。淋巴管瓣功能不全会导致组织纤维化的淋巴水肿和被感染的身体部分严重膨胀。心瓣膜疾病可以导致肺动脉高压和水肿、心房纤颤、以及在二尖瓣和三尖瓣狭窄情况下的右心力衰竭;或者肺充血、左心室收缩性损伤、以及在二尖瓣反流和主动脉狭窄情况下的充血性心力衰竭。不论其病因如何,所有瓣膜疾病导致狭窄,其中瓣膜不适当打开,从而阻碍流体流过并引起流体压力升高,或者功能不全/反流,其中瓣膜并不适当闭合并且流体漏回穿过瓣膜,从而产生回流。一些瓣膜被狭窄和功能不全困扰,这种情况下瓣膜既不完全打开也不完全闭合。
由于瓣膜疾病潜在严重的临床后果,在许多书籍和文献中描述和说明了瓣膜置换术正成为广泛使用的医学程序。当需要进行瓣膜置换时,患病或异常的瓣膜通常被切掉并且用机械瓣膜或组织瓣膜置换。传统的心瓣膜置换术涉及通过胸部的纵向切口进入患者胸腔内的心脏。例如,正中胸骨切开术要求切入胸骨并且强迫胸廓的两个相对的一半分开,以允许进入胸腔和心脏内部。患者然后要接受心肺转流术,其涉及阻止心脏跳动以允许进入内腔。这种心内直视手术是尤其侵入性的并需要漫长和艰难的痊愈阶段。因此,降低或消除病人外科手术时间是目前临床最首要的目标。
用于缩短外科手术时间的一种策略是消除或减少将置换瓣膜缝合到恰当位置的需求。为此,允许用最小或不缝合植入的瓣膜组件是非常有利的。将瓣膜例如组织瓣膜贴附在支承结构诸如支架上,可实现最小或不缝合的植入的瓣膜组件。重要的是,这样的瓣膜结构成一定构造,以致在收缩或扩张状态、或在两种状态期间,组织小叶或支承瓣膜并不能与支承结构接触,从而防止摩擦。这种接触能在瓣膜小叶上造成不希望的应力。此外,有利地,这样的支承结构成一定构造以适当支承具有圆齿形(或波形)流入环面的组织瓣膜,如在美国专利申请序列第09/772,526号中所公开的,上述专利申请的全部内容以引用方式结合于本文。
因此,需要这样一种瓣膜置换系统,其包括能够以最小或无缝合地被固定在恰当位置的可收缩和扩张的瓣膜组件;有利于瓣膜的最优解剖学位置;为可能被置于该瓣膜窦内的脉管的其他脉管开口保留开口路径;以及最小化或降低对组织瓣膜小叶的压力。本发明的瓣膜可以包括多个连接的小叶,并具有相应数目的接合小片(commissural tab)。然而,通常期望的瓣膜包含2至4个小叶以及接合小片。其他合适的瓣膜的实例披露于美国专利申请09/772,526、09/853,463、09/924,970、10/121,208、10/122,035、10/153,286、10/153,290中,其全部内容以引用方式结合于本文。此外,于2004年4月23日提交的美国专利申请10/831,771所披露的系统和方法也以引用方式全部结合于本文。
如上所述,直视心瓣膜置换是冗长的过程。对于主动脉位置的人造生物瓣的植入,外科医生通常打开主动脉并切除天然瓣膜。外科医生随后通过主动脉壁内的开口插入人工瓣膜并将该假体固定在主动脉与左心室接合处。瓣膜的流入环面向左心室,相对于外科医生的观察,可称为远端环,而瓣膜的流出环面向主动脉并可称为近端环。
用于进入左心房和主动脉或二尖瓣的可替换程序是通过血管内导管插入,从股静脉穿过分开右心房和左心房的心脏隔膜。用于进入左心房和主动脉或二尖瓣的又一可替换程序是通过血管内导管插入,从股动脉向上穿过主动脉瓣。
Andersen等人在美国专利第6,582,462号(其全部内容以引用方式结合于本文)中披露了一种用于植入具有内壁的体腔内的瓣膜假体,该假体包括径向可收缩和可扩张的圆柱形支架,所述支架包括具有圆柱体表面的圆柱形支承装置;以及具有缝合点的可收缩和可扩张瓣膜,所述瓣膜在缝合点安装到支架上,其中支架和瓣膜成一定构造以通过导管插入术方法被植入体内。本发明的一个方面是利用与组织瓣膜耦合的可扩张的气囊支架。在本发明中利用可扩张气囊支架的一种可替换的实施方式是利用自扩张支架。本发明利用可扩张气囊支架的又一可替换的实施方式是利用可以用机械装置扩张的支架。
Sterman等人在美国专利第6,283,127(其全部内容以引用方式结合于本文)中披露了装置系统和方法,其有利于介入心脏或较大血管而无需正中胸骨切开术或其他形式的大的胸廓切开术,显著地减少了患者的外伤、并发症的危险、痊愈时间以及疼痛。利用该发明的装置系统和方法,可以通过在患者胸廓的肋骨间区域穿透皮肤进行外科手术,而无需切断、切除、或显著移位患者的任何肋骨或胸骨。这些装置系统和方法尤其适合于心瓣膜的修复和置换,有利于患者胸腔的造影、修复或切除患者的原瓣膜、以及必要时将置换瓣膜贴附在原瓣膜位置。
Haluck在美国专利第6,685,724号(其全部内容以引用方式结合于本文)中披露了用于进行内窥镜手术并具有手柄和细长管件的手术器械,其中细长管件具有与用于外部处置解剖腔的手柄相结合的近端,以及用于设置在解剖腔内的远端。该远端进一步包括一对相对的、可相对活动的爪,其形成通过操作手柄可操作的抓住部分,以可拆地抓住可拆套管针。该可拆套管针具有互补成形的杆(shank),一个相对尖的尖端,且该可拆套管针可包括从套管针的外部表面向外突出的一对钝边缘的组织分离器。
内窥的和最低程度侵入的外科手术,例如腹腔镜检查,已被普遍采用于外科和疾病诊断。这是由于降低了患者的外伤并减少了住院时间。存在其他的用于在体腔内产生工作空间的技术。在多数腹腔镜检查开始时,要制作小的切口,接着在组织壁的剩余层内制作小(约1cm)口,以便能进入体腔。
Hunsberger在美国专利第6,613,063号(其全部内容以引用方式结合于本文)中,披露了套管针组件,其包括具有远端和近端的杆,以及具有两个充分平的面和切削轮廓的平面刺穿刀片,其中刺穿刀片一体连接在杆的远端。杆朝向刺穿刀片的相对的平面向内地逐渐变细。
另外,McFarlane在美国专利第6,478,806号(其全部内容以引用方式结合于本文)中,披露了用于医学领域类型的组织穿透器械,并且其可以或可以不实施为与套管针组件相关的闭塞器的形式,其中所述器械包括具有一长杆,该长杆在其一端安装有穿透尖端。穿透尖端包括固定到该轴一端的座,以及与该座纵向地向外分隔开并形成顶点的远端,该顶点可以被限定成点或其他专门形状的结构,以促进对身体组织的穿透或刺穿。
Spenser等人在美国专利申请09/975,750、10/270,252和10/637,882(其全部内容以引用方式结合于本文)中披露了一种可植入的人工瓣膜,该瓣膜包含支承支架,在初始时卷曲在狭窄构造中以适于通过体内导管导入到目标位置。
消除或减少将置换瓣膜保持于恰当位置的缝合的任何瓣膜的关键特征为:耐久性、瓣膜两侧的低的压梯度、瓣膜周围充分密封以防止瓣膜周的泄漏、以及防止迁移。因此,希望提供具有以下特征的可植入瓣膜:增加耐久性、降低瓣膜两侧的压力梯度,并提供瓣膜周围充分密封和防止迁移。
发明内容
本发明提供瓣膜假体,在一种实施方式中其包含支承支架,该支承支架由可展开结构组成,该可展开结构最初被压褶(缩)成狭窄形状,其适用于穿过体导管到达目标位置的导管插入术,并适于通过展开装置从内部施加足够的径向力而在目标位置被展开成展开状态,该支承支架设有固定长度的多个纵向刚性支承梁;以及瓣膜组件,其包括具有入口端和出口的柔性管,由连接到支承梁的柔韧性材料制成,其提供在管的出口处的可收缩松弛部分,由此当允许经过瓣膜假体装置从入口流到出口的流动时,该瓣膜组件保持在敞开状态,而逆向流动被阻止,因为该瓣膜组件的可收缩松弛部分向内收缩而提供了对逆向流动的阻挡。
在本发明的另一种实施方式中,所述支承支架包括环形框架。
在本发明的又一实施方式中,所述支承支架由不锈钢制成。
在本发明的又一实施方式中,所述瓣膜组件具有三尖瓣构造。
在本发明的又一实施方式中,所述瓣膜组件由生物相容性材料制成。
在本发明的又一实施方式中,所述瓣膜组件由心包组织或其他生物组织制成。
在本发明的又一实施方式中,所述瓣膜组件由生物相容性聚合物组成。
在本发明的又一实施方式中,所述瓣膜组件是由选自由聚氨酯和聚对苯二甲酸乙二酯组成的组的材料制成。
在本发明的又一实施方式中,所述瓣膜组件包括由聚对苯二甲酸乙二酯制成的主体和由聚氨酯制成的小叶。
在本发明的又一实施方式中,所述支承支架由镍钛合金制成。
在本发明的又一实施方式中,所述支承梁基本是等距离的并且基本上平行,以便为瓣膜组件提供固定支座。
在本发明的又一实施方式中,所述支承梁设有穿孔以便可以将瓣膜组件缝合或绑系在梁上。
在本发明的又一实施方式中,所述支承梁未设有穿孔,以便使瓣膜支承结构具有额外的刚性。
在本发明的又一实施方式中,所述支承梁被化学粘附至支承支架。
在本发明的又一实施方式中,所述瓣膜组件被铆接至支承梁。
在本发明的又一实施方式中,所述梁通过利用模具注射或通过机加工来制造。
在本发明的又一实施方式中,所述瓣膜组件在入口侧被卷在支承支架上。
在本发明的又一实施方式中,所述瓣膜装置是利用锻造技术或浸渍技术来制造。
在本发明的又一实施方式中,所述瓣膜组件小叶长于恰巧闭合出口所需要的尺寸,因此当它们处于收缩状态时,小叶的很大部分彼此叠合以产生更好的密封。
在本发明的又一实施方式中,所述瓣膜组件由聚合物的线圈(coil)制成,其涂覆了相同聚合物的涂层。
在本发明的又一实施方式中,所述聚合物是聚氨酯。
在本发明的又一实施方式中,所述支承支架装备有重金属标记物(marker),以便可以跟踪并测定所述瓣膜装置的位置和方向。
在本发明的又一实施方式中,所述重金属标物记选自金、铂、铱、钽、钴、铬、以及钛合金。
在本发明的又一实施方式中,所述瓣膜组件小叶在出口处装备有不透射线物质,以便帮助跟踪体内的瓣膜装置的操作。
在本发明的又一实施方式中,所述不透射线物质包括金丝。
在本发明的又一实施方式中,所述支承支架当完全展开时的直径为约15至约33mm。
在本发明的又一实施方式中,所述支承支架的直径可以从约4mm扩展到约25mm。
在本发明的又一实施方式中,所述支承支架的直径可以从约10mm扩展到约25mm。
在本发明的又一实施方式中,所述支承梁设有穿孔,并且其中所述瓣膜组件通过U形刚性构件被连接到支承梁上,所述U形刚性构件被紧固到瓣膜组件上并设有穿进在支承梁上的匹配穿孔的挤压部分。
在本发明的又一实施方式中,所述支承梁包括形式为框架结构的刚性支承梁,并且所述瓣膜组件柔性材料通过框架中的间隙被插入,并且固紧棒通过在该柔性材料和框架之间形成的袋被插入,并且保持瓣膜在适当的位置。
在本发明的又一实施方式中,所述瓣膜组件的主体由覆盖涂料的绕线(coiled wire)制成。
在本发明的又一实施方式中,所述绕线和涂料由聚氨酯制成。
在本发明的又一实施方式中,一加强线被交织在瓣膜组件内该导管的出口处,以便确定一个分界线(fault line),该瓣膜组件的可收缩松弛部分可以以此分界线进行折叠。
在本发明的又一实施方式中,所述加强线由镍钛合金制成。
在本发明的又一实施方式中,提供了适于植入体导管的瓣膜假体装置,该装置包括具有入口和出口的主管体以及连接在出口的柔性小叶,使得当流体经过管从入口流向出口时,小叶处于敞开状态以允许流体从出口流出,并且当流体反向时小叶收缩而阻挡出口,其中该主体由聚对苯二甲酸乙二酯制成并且可收缩小叶由聚氨酯制成。
在本发明的又一实施方式中,由聚氨酯制成的支承梁设置在主体上,且其中所述小叶在支承梁处连接到主体上。
在本发明的又一实施方式中,所述支承梁被化学粘附到主体。
在本发明的又一实施方式中,提供了适于植入体管内的瓣膜假体装置,该装置包括:
支承支架,该支承支架由可展开结构构成,该可展开结构适于在起初被压缩成狭窄形状并适用于穿过体导管到达目标位置的导管插入术,并适于在目标位置通过展开装置从内部施加足够的径向力而被展开成展开状态,该支承支架设有固定长度的多个纵向刚性支承梁;
瓣膜组件,其包含由柔性材料制成的具有入口和出口的柔性管,并且被连接到支承梁上,从而在管的出口处提供可收缩松弛部分;以及
基本等距离的刚性支承梁,其交织或粘附到瓣膜组件材料的松弛部分,并沿纵向布置。
在本发明的又一实施方式中,通过手柄(杆)和传送装置(transmission)同时移动多个板。
在本发明的又一实施方式中,提供了用于在进入患者心肌左心室的自然主动脉瓣的位置上展开可植入假体瓣膜装置的方法,该方法包括以下几个步骤:
(a)提供气囊导管,其具有近端和远端,具有第一和第二独立可充气部分,所述第一可充气部分位于导管的远端,并且所述第二可充气部分邻近地在第一可充气部分的后面;
(b)提供用于在患者脉管系统内引导气囊导管的导向工具;
(c)提供适合安装在气囊导管的第二可充气部分的可展开可植入的瓣膜假体装置;
(d)使用导向工具引导气囊导管通过患者的主动脉,瓣膜装置安装在气囊导管的第二可充气部分,直到气囊导管的第一可充气部分被插入到左心室,而气囊导管的第二可充气部分被安置在自然主动脉瓣的位置;
(e)充气该气囊导管的第一可充气部分,以便基本阻塞血液流过自然主动脉瓣,并将气囊导管的远端固定在适当的位置;
(f)充气该气囊导管的第二可充气部分,以便在自然主动脉瓣位置的适当位置上展开可植入的假体瓣膜装置;
(g)对该气囊导管的第一和第二可充气部分进行放气;以及
(h)收回气囊导管并从患者的体内移开气囊导管。
在本发明的又一实施方式中,所述导向工具包括导线(guidewire)。
在一些其他实施方式中,本发明提供了用于在进入患者心肌左心室的自然主动脉瓣的位置上展开可植入假体瓣膜装置的方法,该方法包括以下步骤:
(a)提供具有近端和远端、具有第一和第二独立可充气部分的气囊导管,所述第一可充气部分位于导管的远端,并且所述第二可充气部分邻近地在第一可充气部分的后面;
(b)提供用于在患者脉管系统内引导气囊导管的导向工具;
(c)提供适合于安装在气囊导管的第一可充气部分的可展开可植入的瓣膜假体装置,以及适合安装在气囊导管的第二可充气部分上的可展开的环形支架装置,可展开可植入的瓣膜假体装置和可展开的环形支架装置保持相隔预定的距离;
(d)使用导向工具引导气囊导管通过患者的主动脉,瓣膜装置被安装在气囊导管的第一可充气部分上,而可展开的环形支架被安装在气囊导管的第二可充气部分,直到气囊导管的第一可充气部分被置于自然主动脉瓣位置;
(e)给该气囊导管的第二可充气部分充气,以便可展开支架装置在主动脉内展开,从而将可展开环形支架以及连接的瓣膜装置固定在适当位置;
(f)给该气囊导管的第一可充气部分充气,以便在自然主动脉瓣位置的适当位置上展开可植入假体瓣膜装置;
(g)给该气囊导管的第一和第二可充气部分放气;以及
(h)收回气囊导管并将其从患者的体内移开。
在本发明中描述的瓣膜装置的一个目的是提出一种将组织瓣膜放在支承结构上的新型装置。将组织瓣膜放在支承结构上的装置可以增加瓣膜的耐用性、降低横穿瓣膜的压力梯度、在瓣膜周围提供密封以防止瓣膜周围的泄漏并防止迁移。本发明的瓣膜可以包括多个与接合小片数目对应的相连接的小叶。然而,通常,需要的瓣膜将包含2至4个小叶和接合小片。
在本发明的一种实施方式中,瓣膜与披露于美国专利申请09/772,526、09/853,463、09/924,970、10/121,208、10/122,035、10/153,286、10/153,290中的瓣膜相类似,上述美国专利申请的全部内容以引用方式结合于本文。在这些申请中描述的瓣膜直径可以等于或小于瓣膜支承结构的孔直径。
在本发明的又一实施方式中,在美国专利申请09/772,526、09/853,463、09/924,970、10/121,208、10/122,035、10/153,286、10/153,290中披露的瓣膜,瓣膜尺寸设置成使得有效瓣膜的直径小于瓣膜支承结构的孔直径1~5mm。这种尺寸将有助于防止瓣膜小叶碰撞支承结构。
在本发明的又一实施方式中,所述瓣膜由马心包膜制成。
在本发明的又一实施方式中,瓣膜组件的翻边(例如,织物)部分在入口处包在支承支架周围。这可以提高支架的稳定性,但是另外,本发明中描述的翻边部分可以用于连接缝合处。最重要地,本发明的翻边部分能降低瓣膜周围的瓣周漏。利用这种翻边在瓣膜结构和主动脉之间产生密封,可以防止瓣周漏,并对于其环(或瓣膜接触区)被钙化或不规则的患者是特别重要的。该翻边还可以防止瓣膜的迁移,因为瓣膜装置和周围之间的摩擦被增大。利用织物翻边还可以诱导组织向内生长。织物在暴露于血液时,该织物最初会使血凝结。该织物可以进一步诱导内皮和成纤维细胞,因此组织向内长入织物翻边。
在本发明的又一实施方式中,所述织物翻边在覆盖在瓣膜组件的入口部分的薄织物和厚织物之间产生台阶,该薄织物过渡至组件的稍微下游的厚得多的织物翻边上。这种“唇缘”或“台阶”可以帮助定位并将瓣膜假体固定在恰当位置上。
在本发明的又一实施方式中,描述于美国申请09/772,526、09/853,463、09/924,970、10/121,208、10/122,035、10/153,286、10/153,290中的圆齿状的流入边缘被缝合在上面所描述的瓣膜组件的翻边(cuff)部分。因此,所述翻边的另一应用是允许具有圆齿状的流入边缘的瓣膜连接到非圆齿状的支架。
在本发明的又一实施方式中,所述支架的支承梁在流入部分附近被延伸,以容纳较长瓣膜的长度,例如在美国申请09/772,526、09/853,463、09/924,970、10/121,208、10/122,035、10/153,286、10/153,290中描述的瓣膜。
在本发明的又一实施方式中,所述支承梁在流出边缘上形成孔眼,其中描述于美国申请09/772,526、09/853,463、09/924,970、10/121,208、10/122,035、10/153,286、10/153,290的瓣膜小片可以连接到该边缘。该瓣膜小片可以沿孔眼的周围缝合到孔眼上。这种结构有助于将应力分布于小片的周围,并降低对瓣膜接缝柱(commissural posts)的磨损和拉扯。
在本发明的又一实施方式中,上面描述的支承梁孔眼被织物覆盖。用织物覆盖孔眼和小片可以帮助诱导组织向内生长。
在本发明的又一实施方式中,所述瓣膜装置被如此制成以致它不会被压缩至小于典型股动脉或股静脉的直径(其中导管通常不大于8mm)。换句话说,瓣膜装置被如此制成以致其不能通过股动脉或股静脉被植入。
在本发明的又一实施方式中,所述瓣膜装置在其被生产后就被压缩,并在压缩状态下从制造商处被运送到医院或将要进行植入的地方。
在本发明的又一实施方式中,所述支架由形状记忆金属或形状记忆聚合物制成。
在本发明的又一实施方式中,所述瓣膜装置的支架被制成是气囊可扩展的。
在本发明的又一实施方式中,所述瓣膜装置的支架被制成是可自行扩展的。
本发明提供了用于生理瓣膜置换的系统和装置。在本发明的一种实施方式中,置换瓣膜组件适合于充分地安置在瓣膜窦内。由于本发明提供的装置和方法消除或减少缝合的需要,所以显著减少了外科手术花费的时间,并且将与手术相关的风险降至最低。另外,本发明的装置适合于通过套管或导管递送。
在本发明的又一实施方式中,所述瓣膜装置的支架被如此制成以致在气囊膨胀期间扩张到窦区域。
在本发明的又一实施方式中,所述瓣膜装置的支架被如此制成以致在自行膨胀期间扩张到窦区域。
在本发明的一个实施方式中,提供了瓣膜固定结构,其尺寸足以充分地置于瓣膜窦内。在该实施方式中,瓣膜固定结构基本上延伸穿过瓣膜窦区域的长度。
在本发明的又一实施方式中,提供了瓣膜组件,其包括瓣膜和固定结构,其中所述瓣膜包括具有近端和远端的主体、在近端的入口、以及在远端的出口。所述入口包括带有圆齿边或直边的流入环状部。出口包括多个在远端受到固定装置支承的小片。在本发明的一种实施方式中,多个小片沿瓣膜的周围被均匀地隔开。
在本发明的又一实施方式中,提供了瓣膜组件,其中在瓣膜和固定结构之间存在最小接触或没有接触。
在本发明的另一实施方式中,提供了瓣膜组件,其中瓣膜能完全打开并能完全闭合,而不接触固定结构。
在本发明的又一实施方式中,提供了瓣膜组件,其中固定结构的垂直构件被限制在窦腔之间的接缝柱,从而使机械构件和流体之间的接触降低到最低程度,并提供向位于瓣膜窦内的血管的流动。
在本发明的另一实施方式中,提供了瓣膜,其稳固地连接至瓣膜窦,从而无需缝合来固定瓣膜的位置。
在本发明的进一步实施方式中,提供了瓣膜组件,其中固定结构可以收缩到其最大直径的至少50%。
在本发明的另一实施方式中,提供了膨胀和收缩装置,以促进瓣膜和固定结构的植入。
在又一实施方式中,本发明提供了用于将瓣膜组件固定在瓣膜窦内的粘合装置。
在本发明的又一实施方式中,提供了用于天然瓣膜尺寸的非侵入性测定的瓣膜尺寸调整装置。
附图说明
为了更好地理解本发明并理解其实际应用,提供了下面的附图和在下文加以参照。应当注意到,给出的附图仅仅是示例性的而不是限制本发明的范围。
图1示出了从侧面观察的瓣膜结构、支架、或框架。
图2示出了从侧面观察的瓣膜结构、支架、或框架。
图3示出了从等视轴角度观察的瓣膜结构、支架、或框架。
图4示出了从顶部(即,在流出侧)观察的瓣膜结构、支架、或框架。
图5示出了在流入边缘周围具有织物覆盖的框架。
图6示出了在流入边缘周围具有织物覆盖的框架。
图7示出了在流入边缘周围具有织物覆盖的框架。
图8示出了在流入边缘周围具有织物覆盖的框架。
图9示出了在流入边缘周围具有织物覆盖的框架。所述瓣膜也附在该图中。瓣膜的小片与框架的孔眼对齐。
图10示出了在流入边缘周围具有织物覆盖的框架。所述瓣膜也附在该图中。瓣膜的小片与框架的孔眼对齐。
图11示出了在流入边缘周围具有织物覆盖的框架。所述瓣膜也附在该图中。瓣膜的小片与框架的孔眼对齐。
图12示出了在流入边缘周围具有织物覆盖的框架。所述瓣膜也附在该图中。瓣膜的小片与框架的孔眼对齐。
图13示出了在流入边缘周围具有织物覆盖的框架。所述瓣膜也附在该图中。瓣膜的小片与框架的孔眼对齐。织物已被加入并保持将瓣膜小片连接到框架孔眼。
图14示出了在流入边缘周围具有织物覆盖的框架。所述瓣膜也附在该图中。瓣膜的小片与框架的孔眼对齐。织物已被加入并保持将瓣膜小片连接到框架孔眼。
图15示出了在流入边缘周围具有织物覆盖的框架。所述瓣膜也附在该图中。瓣膜的小片与框架的孔眼对齐。织物已被加入并保持将瓣膜小片连接到框架孔眼。
图16示出了在流入边缘周围具有织物覆盖的框架。所述瓣膜也附在该图中。瓣膜的小片与框架的孔眼对齐。织物已被加入并保持将瓣膜小片连接到框架孔眼。
图17示出了描述于美国申请09/772,526、09/853,463、09/924,970、10/121,208、10/122,035、10/153,286、10/153,290中的一种小叶,并且示出了其如何与框架和框架孔眼对齐。为了清楚显示,已将环绕流入边缘的织物翻边去除。
图18示出了原型瓣膜假休的流出侧面。
图19示出了原型瓣膜假体的流入侧面。
图20示出了原型瓣膜假体的侧视图。
图21示出了压褶(被压缩)到7.5mm的瓣膜组件支架。
图22示出了瓣膜小片组装到框架孔眼。
图23示出了小片/孔眼组件的最终织物覆盖。
具体实施方式
本发明的主要方面是介绍几种可植入假体瓣膜的新型设计。本发明的另一方面是公开了几种用于制造根据本发明的可植入假体瓣膜的制造方法。本发明的又一方面是提供适合于本发明瓣膜的新的展开和定位技术。
本发明的可植入假体瓣膜基本上包括叶状瓣膜组件,优选三尖瓣但不仅限于三尖瓣,其包括具有入口端和出口的导管,由柔韧性材料制成,以致在出口处呈现可收缩壁。该瓣膜组件被安装在支承结构,例如适合定位在体导管内目标位置的支架上,并通过使用展开装置例如气囊导管或类似装置来展开该瓣膜组件。在适合于安全且方便的经皮定位和展开的实施方式中,环形框架可以处于两种状态,即,压缩状态,在该状态导管通道的横断面较小,以便允许将该装置推进至其目标位置,以及展开状态,在该状态框架被自内部施加的力径向展开(通过展开装置),以便给体导管壁提供支承,将瓣膜固定在适当位置并使其自动打开以便使流体能流过导管。
该瓣膜组件可以由生物物质制成,例如天然组织、心包组织或其他生物组织。可替换地,该瓣膜组件可以由生物相容性聚合物或类似材料制成。同种移植生物瓣膜需要不定时的更换(通常在5~14年内)并且当根据患者类型选择适合的瓣膜植入物时,外科医生必须要考虑这一点。金属机械瓣膜具有更好的耐用特性,但存在长期抗凝治疗的相关风险。
该框架可以由形状记忆合金制成,例如镍钛(例如以商标名Nitinol销售的镍钛形状记忆合金或NiTi)、或其他生物相容性金属。本发明的可植入瓣膜的经皮可植入的实施方式必须适合于压缩成狭窄的形状,以便定位并可扩展到较宽的展开形状,这样便可以锁定在希望的目标位置。
支承支架优选为环形的,但也可以是其他形状,这取决于所希望的目标位置通道的横截面形状。
本发明的可植入假体瓣膜的制造可以使用各种方法,例如浸渍、注入、电纺丝(electrospinning)、旋转、挤拉(ironing)、或按压(pressing)。
瓣膜组件与支承支架的连接可以以几种方式来实现,例如通过将它缝合到支承支架上的几个固定点、或铆接它、或扣住它、或粘附它,以提供浇铸或模制在支承支架上的瓣膜组件,或利用任何其他适合的附着方法。
为了防止从入口的泄漏,可选地可以将入口的部分松弛壁卷起在框架的边缘上,从而在入口提供卷起的袖子状部分。
另外,可以加入浮动支承(架)以提高装置的稳定性,并防止它翻过来。
本发明的一些实施方式的一个重要方面是提供与支承支架结合的刚性支承梁,该支承支架保持其纵向尺寸,而整个支承支架可以纵向或横向延伸。
以下参考附图讨论和解释上述实施方式及其他实施方式、制造方法、不同设计以及不同类型的装置。注意,附图仅用来理解本发明,并提供本发明的一些优选的实施方式,但并不以任何方式限制如在所附权利要求中所规定的本发明的范围。
现在参考图1,其例举了处于展开状态的瓣膜支承结构或框架。该框架具有入口侧9和出口侧10。该框架被设置成网状框架,其可以均匀压缩以便呈现窄的形状,并且可以径向展开,以便扩展从而占据体导管内用于植入的目标位置处的通道。支承梁3设在环形支承支架2上以提供刚性以及瓣膜的固定支座。支承梁3可以设有穿孔以为瓣膜提供附着。在该图中,所述支承梁是实心的,以便为该支架提供额外的刚性。该支承梁3在流出侧的一边变成椭圆孔眼1。
图2至图4示出了图1所示的同一框架从不同角度的视图。
注意,整个瓣膜结构适合于径向压缩以及径向地扩展,这有利于在装置定位期间该装置通过脉管的狭小通道的移动和在最终位置的充分展开。通过提供可收缩支承支架结构,使得上述变为可能。然而,支承梁一直维持相同长度。由于支承梁保持相同长度,所以在压缩和膨胀状态,在流入侧边缘和瓣膜小片附件之间的距离保持不变。这使得瓣膜可以恰当地发挥其功能。在现有技术的可植入瓣膜装置中,整个支承结构从初始的第一压缩状态到最后展开状态会改变其尺寸,这意味着,将该瓣膜组件附着到支承结构时必须考虑这些尺寸变化并留下松弛的材料,以致当该装置展开时,该瓣膜组件并不撕裂或变形。在本发明的瓣膜装置中,在瓣膜组件和支承梁(沿着装置的纵向中心轴)之间不存在相对运动。结果,本发明的瓣膜装置获得更大的耐久性并且能承受心脏内部呈主导性的苛刻条件。本发明的瓣膜装置的新型设计产生纵向强度和刚性,而其可收缩支承结构导致径向柔软性。
图5示出了在支架流入侧边缘的织物翻边(4和5)。该织物翻边可以由薄的织物翻边5和厚的织物翻边4构成,由此在这两个翻边之间的交接处形成唇缘11。这种“唇缘”或“台阶”可以帮助将瓣膜假体定位并固定在适当位置上。例如,当置于主动脉位置时,它可以帮助将瓣膜假体保持在流入环面上。
图6~8示出了图5所示的相同框架和组织翻边从不同视角的视图。
图9示出了披露于美国专利申请09/772,526、09/853,463、09/924,970、10/121,208、10/122,035、10/153,286、10/153,290中的一种瓣膜6。瓣膜的小片7与支承梁的孔眼1对齐。孔眼1的整体大小与小片7的大小匹配。瓣膜6被附着在框架的流入侧9,并且被缝合到织物翻边5和4上。
图10~12示出了图9所示的相同瓣膜组件从不同视角的视图。
图13示出了整个瓣膜组件。在该图中,小片7和孔眼1用织物8覆盖。用织物翻边覆盖小片7可以诱导组织内生长。当暴露于血液时,织物最初可以凝结。该织物可进一步诱导内皮细胞向内生长和成纤维细胞向内生长,因此诱导组织向内生长。诱导组织向内生长将降低施加到支架的载荷。以这种方式用织物8覆盖小片7和孔眼1,还有助于将接缝柱承受的载荷分布在整个小片上,从而降低对瓣膜接缝柱的磨损和拉扯。
图14~16示出了图13所示的相同瓣膜组件从不同视角的视图。
图17示出了描述于美国申请09/772,526、09/853,463、09/924,970、10/121,208、10/122,035、10/153,286、10/153,290中的一种小叶12,并且示出了其如何对齐框架15和框架孔眼13。为了清楚起见,已除去流入侧边缘周围的织物翻边。在图17中显而易见的另一实施方式是如何相对于支架15的入口来定位小叶14的圆齿状边缘。
图18~20示出了已装配好的样品瓣膜的图片。
图21示出了支架被压缩到7.5mm的图片。
图22示出了将瓣膜小片组装到框架孔眼。
图23示出了小片/孔眼组件的最终织物覆盖。
主动脉人工瓣膜的典型尺寸为直径约19至约31mm。插入股动脉的导管的最大尺寸应是直径不大于8mm。本发明引入了一种装置,该装置能使其直径在约4至约33mm内变化。人工瓣膜不是新的,然而,根据本发明的人工瓣膜具有为了递送而改变形状和尺寸的能力,其同样也是新的。这些用新方法设计的瓣膜需要新的生产方法和技术发明以及改进,其部分内容在本文已有描述。
如上所述,本发明的一种实施方式是使得支架不可能被压缩至小于股动脉或静脉的尺寸。换句话说,可以造成机械止挡或添加组织或织物,这样来防止支架被压缩至小于股动脉或静脉尺寸。以这种方式,支架被如此制成,以致有意地不能使用它通过股静脉或股动脉入口。产生对瓣膜组件的这种尺寸限制使得可以产生更坚固的装置以延长瓣膜组件的寿命。这种装置可以通过心尖被植入,如在于2004年4月23日提交的题为“Method and System for CardiacValve Delivery”的美国专利申请中所详细描述的。同时提交了此文献的早期版本作为最近的临时申请。目前暂未得到其申请号。该申请附加于此临时专利申请,因此,其全部内容包含于本申请中。
如上所述,制备瓣膜的材料可以是生物或人造材料。无论如何,需要新技术来制造这种瓣膜。
为了将瓣膜附着到体内,血管确定了在递送期间的尺寸,以及为使其有效工作应满足的要求,所以需要将其安装在可收缩结构上,所述可收缩结构可以压缩至较小尺寸、扩张至较大尺寸、以及足够坚固以作为瓣膜功能的支持。这种结构,其有点类似于大的“支架”,可以由不同材料制成,例如镍钛形状记忆合金、生物相容性不锈钢、聚合材料或所有上述材料的组合。对于支架的特殊要求是本文讨论的某些实施方式的主题。
瓣膜在可收缩支架上的安装是新领域的问题。本文描述了解决这种问题的新方法。
本发明的瓣膜设计的另一主要方面是附着在身体上。
瓣膜装置的另一主要方面是附着瓣膜到框架上。
在传统做法中,瓣膜通过复杂的缝合操作被缝合在适当的位置。在经皮手术的情况下,没有进入植入部位的直接通路,因此需要不同的附着技术。
本文解决的另一个新问题是递送步骤,其是新的并且独特的。在体内以精确的位置和方向对装置进行定位,需要装置和手术点的特别的标记和测量方法,这在本文有所披露。
当保持在架子上时,人工聚合物瓣膜需要特殊处理和特殊条件,以及特殊的杀菌步骤。架子处理的一个结果是在植入手术期间需要压褶瓣膜。本文披露了一系列装置和发明以使得可以进行压褶步骤。
应当明了,在此说明书中对具体实施方式和附图的描述仅是用来更好地理解本发明,而不是限制权利要求所涵盖的本发明的范围。
Claims (1)
1.一种人工瓣膜组件,包括:
(a)瓣膜,所述瓣膜具有入口端和出口,并由柔韧性材料制成,以致在所述出口处提供可收缩壁;以及
(b)支承结构,所述支承结构适合于定位在体导管内的目标位置,并通过利用展开装置展开所述瓣膜组件。
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2005
- 2005-04-22 BR BRPI0510107-7A patent/BRPI0510107A/pt not_active Application Discontinuation
- 2005-04-22 CN CNA2005800202479A patent/CN101052359A/zh active Pending
- 2005-04-22 US US11/112,757 patent/US20060025857A1/en not_active Abandoned
- 2005-04-22 JP JP2007509662A patent/JP5290573B2/ja not_active Expired - Fee Related
- 2005-04-22 EP EP05739319A patent/EP1753374A4/en not_active Withdrawn
- 2005-04-22 WO PCT/US2005/013746 patent/WO2005102015A2/en active Application Filing
- 2005-04-22 AU AU2005234793A patent/AU2005234793B2/en not_active Ceased
-
2007
- 2007-03-12 US US11/685,025 patent/US9775704B2/en active Active
-
2010
- 2010-03-23 JP JP2010066964A patent/JP2010188140A/ja active Pending
-
2012
- 2012-12-21 JP JP2012280031A patent/JP2013066772A/ja active Pending
-
2017
- 2017-08-24 US US15/685,395 patent/US20180036122A1/en not_active Abandoned
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CN102481189A (zh) * | 2009-06-05 | 2012-05-30 | 美敦力Ats医药股份有限公司 | 带有具有凹入着陆区域的锚固结构的心瓣膜 |
CN102481189B (zh) * | 2009-06-05 | 2014-12-10 | 美敦力Ats医药股份有限公司 | 带有具有凹入着陆区域的锚固结构的心瓣膜 |
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CN103228231A (zh) * | 2010-09-23 | 2013-07-31 | 科利柏心脏瓣膜有限责任公司 | 带有具有近腔定位组织膜的框体的可经皮递送的心脏或血管瓣膜 |
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CN105578991B (zh) * | 2013-05-29 | 2017-11-14 | M阀门技术有限公司 | 装配有瓣膜瓣叶心脏瓣膜支撑装置 |
WO2020207332A1 (zh) * | 2019-04-08 | 2020-10-15 | 北京佰仁医疗科技股份有限公司 | 一种支架和瓣叶的连接结构及应用该连接结构的介入瓣中瓣和介入主动脉瓣 |
WO2020207331A1 (zh) * | 2019-04-08 | 2020-10-15 | 北京佰仁医疗科技股份有限公司 | 一种支架和瓣叶的连接结构及应用该连接结构的介入肺动脉瓣和介入主动脉瓣 |
RU2712041C1 (ru) * | 2019-07-16 | 2020-01-24 | Общество с ограниченной ответственностью "Специальное конструкторское бюро медицинской тематики" (ООО "СКБ МТ") | Каркас для биологического протеза клапана сердца |
Also Published As
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US20070270944A1 (en) | 2007-11-22 |
JP5290573B2 (ja) | 2013-09-18 |
EP1753374A4 (en) | 2010-02-10 |
JP2010188140A (ja) | 2010-09-02 |
JP2007534381A (ja) | 2007-11-29 |
US9775704B2 (en) | 2017-10-03 |
US20180036122A1 (en) | 2018-02-08 |
US20060025857A1 (en) | 2006-02-02 |
BRPI0510107A (pt) | 2007-09-25 |
AU2005234793A1 (en) | 2005-11-03 |
JP2013066772A (ja) | 2013-04-18 |
WO2005102015A2 (en) | 2005-11-03 |
EP1753374A2 (en) | 2007-02-21 |
WO2005102015A3 (en) | 2007-04-19 |
AU2005234793B2 (en) | 2012-01-19 |
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