CN1596090A - 僧帽瓣假体 - Google Patents
僧帽瓣假体 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
- A61F2/2457—Chordae tendineae prostheses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
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Abstract
本发明涉及一种僧帽瓣假体,其包括具有弯曲接合表面的柔性小叶状元件(24,25)以及用于在插入僧帽环时保持瓣膜连续性的装置(36),其能模拟乳突状肌肉(12),索腱(10),僧帽瓣小叶和天然瓣膜的僧帽环之间的连续性。本发明还涉及一种将这种假体安装在患者心脏上的方法。
Description
本发明的领域
本发明涉及一种僧帽瓣假体,并且涉及将这种假体安装至患者心脏上的方法。
背景技术
僧帽瓣能够控制在左心房(从肺脏流出的血液的接收腔室)和使血液注入主动脉(通过其支路绕身体分配血液的主动脉)的左心室(心脏的高压肌肉泵送腔室)间孔口处的血流。当左心室肌肉松弛时,左心室的腔室膨胀以通过打开的僧帽瓣接收血液(图1);当左心室4的肌肉收缩时,僧帽瓣小叶6,7闭合并且经打开的主动脉瓣15,将左心室4中的血液排入主动脉14(图2)。当左心室收缩时,僧帽瓣具有防止血液回流入左心房8内的功能。
僧帽瓣具有两个主小叶-前侧和后侧小叶6,7(在这两者之间可能存在较小的小叶)。所述小叶是柔性的并且固定至环(环绕僧帽瓣的孔口的坚韧、纤维状区域)。由小叶产生纤维状带(索腱)。这些索腱中最重要的部分(主要索腱10)从小叶6,7的自由边缘延伸至被称为前部-侧向和后部-中间乳突状肌肉12的左心室肌肉的两个特定的增厚区域。前侧和后侧小叶的中央半个部分固定至后部-中间乳突状肌肉上,而前侧和后侧小叶的横向半体固定至前部-侧向乳突状肌肉上。乳突状肌肉12可具有多个头,但是,通常对于每一块肌肉而言,主肌肉体是可以辨认出的。
由于先天线性畸形(不常见)的原因或由于风湿热或变性疾病的原因,僧帽瓣可能出现异常现象。当瓣膜结疤时,增厚或钙化(在风湿性病患者的瓣膜中较为常见)的瓣膜会变得狭窄(功能性狭窄)并且会阻碍血液流动,结果会使肺脏充血,从而导致患者呼吸困难。在使瓣膜膨胀时或使索断裂时,瓣膜泄露,从而导致左心房中的压力增加并且肺脏充血,并且导致心率下降。
虽然在外科手术中可以修复许多异常的僧帽瓣,但是,大量的异常情况则是不可能修复的。更换装置(假体)为大致两类:生物瓣膜来自于动物并且与正常的主动脉瓣极为相似,从而可以采用猪的主动脉瓣或由小牛的心包制成的类似装置(安装在构架并且被适当处理以确保无菌和相当耐久的装置);机械瓣膜由金属合金或碳制成,与天然瓣膜不相似。机械瓣膜通常采用倾斜的盘或双叶片(两个一半的盘),在该处使封闭盘或一半的盘保持或铰接在圆形壳体内,该壳体本身由一个织物缝制环包围,以有助于一旦已除去病变的瓣膜,便可以缝制在僧帽瓣孔口内。
适于临床植入的目前的假体瓣膜的设计通常都不理想。除了存在与心脏瓣膜相关的通常问题(生物型式易于变质和钙化并且特别是在年轻患者中耐久性是有限的;机械型式则需要终身防止凝血以使他们产生血液凝结和血栓栓塞的危险性降至最小),当在僧帽位置处使用它们时,则会产生另外的问题。在主动脉的位置处,通过上述两种类型的假体的流动非常接近正常的流动(特别是对于结构上与天然主动脉瓣膜非常相似的生物假体而言)。在僧帽的位置处,流动更为复杂,其包括不能由目前的假体再现的在左心室腔室中的涡流。其通常可很好地有助于僧帽假体的附加凝血酶原(thrombogencity)。由于损失了索的功能,因此,临床假体瓣膜与天然僧帽瓣是不同的,从而在经过一定时间后会对左心室功能造成不良影响。与主动脉瓣膜更换相比,在僧帽位置处会增强与机械瓣膜所需的抗凝血治疗相关的问题。生物假体以对心室肌肉造成直接损害的可能伸入心室内。在心脏学上的研究有希望消除心房纤维性颤动,一种需要抗凝血治疗的僧帽瓣疾病的常见并发症。其能够使非凝血酶原僧帽瓣膜得到更广泛的应用。
已披露了多种可能的僧帽瓣假体。在1960年(Braunwald NS,CooperT,Morrow AG.Experimental replacement of the mitral valve with aflexible polyurethane foam prosthesis.Trans Am Soc Artif InternOrgans 1960;6:312-322)对模拟天然僧帽瓣的假体作了最早的说明。瓣膜小叶由开孔单元聚氨酯泡沫塑料(其由细织涤纶织物加强)制成。在修整了小叶的形状后,将由纺织聚四氟乙烯织物带制成的索缝合至小叶上。在对狗进行的试验性植入研究期间,通过在乳突状肌肉插入物附近的心室壁固定索,并且在狗仍处于局部灌注时,对所述索进行手动调节,随后利用聚四氟乙烯毡件将其固定至心室壁肌肉上。对五名患者(Braunwald NS,Cooper T,Morrow AG.Clinical and ExperimentalReplacement of the Mitral Valve.In:Merendino KA(Ed.),“Prosthesic Valves for Cardiac Surgery”,CharlesThomas,Springfield,Illinois,1961,pp 307-399.)中已进行了这种瓣膜的临床应用。三名患者因手术的并发症而死亡。另一个患者存活了14个小时,并发展为难以治疗的血压过低。未能确定导致死亡的特定原因。第5名患者在手术后存活了三个月。同样,仍没能确定导致死亡的特定原因,并且没有记录与瓣膜相关的病理学。但记录了与这种设计的索张紧的方法相关的并发症,其包括不可控制的从患者心室的出血。
国际专利WO 149217A(美国专利5,910,169),Total mitralheterologous bioprosthesis to be used in mitral tricuspid heartreplacement,Peredo MOV,披露了一种由动物原材料获得的天然僧帽瓣瓣膜(异种移植),外加用以支承瓣膜环的心包组织。所述瓣膜由索和所包括的乳突状肌肉获得。通过一个补片强化切去的乳突状肌肉。还描述了未固定的同种移植瓣膜。瓣膜的尺寸与受体相匹配。
美国专利US 5,415,667,Mitral Heart Valve Replacement,FraterRW披露了一种完全柔性的非弹性生物可结合的未扩张的置换僧帽瓣,其没有伸入心室腔内的刚性部分。虽然以D形环对这种瓣膜进行了说明,但是,它们最好使用梯形以避免在打开和闭合期间小叶结构产生弯曲/褶叠或折皱。所述瓣膜具有四个尖瓣:一个在前部;一个在后部以及两个在侧面,并且索从小叶边缘延伸至乳突状肌肉。任何一个独立的索均通过缝合至尖瓣边缘上固定,或者,最好通过整体乳突状肌肉固定件与小叶尖瓣形成一体。尖瓣、索和乳突状肌肉固定件如图所示,由从尖瓣延伸至固定件的非弹性材料加强:类似的加强件如图所示,沿尖瓣的自由边缘或中部延伸。所使用的瓣膜材料为心包或非生物材料:加强件应使用压制的聚四氟乙烯(ePTFE)缝合来防止伸展。在两种情况下,瓣膜的材料应允许具有纤维状组织的材料和内皮能够过度生长以使假体完全由正常的宿主组织覆盖。尖瓣的总表面区域越过由缝合环限定的区域,以便在瓣膜打开时,乳突状肌肉会牵引所述索并且尖瓣彼此偏离。瓣膜为一种四-小叶瓣膜,其具有固定至小叶尖瓣的边缘上或从小叶尖瓣的边缘上伸出的索,并且可以带有小叶材料的表面加强件。
美国专利US 5,344,442,Cardiac Valve,Deac R披露了一种僧帽瓣假体,其由锥形管形状形成并且没有独立的小叶。自由端部为椭圆形并且可以带有具有不等尺寸的多个整体舌瓣。所述管件由心包膜或缝合在一起的其它适当的生物或合成织物构成。管形形状从环向下延伸至乳突状肌肉上,乳突状肌肉在两个“整体舌瓣”处直接固定至索的剩余部分上。瓣膜在配合僧帽位置时,与正常的僧帽瓣膜形状并不相似并且不具有索的功能。通过缝合由管状瓣膜的缝合缝保留的缝合距离形成乳突状肌肉的固定,并且所述组织由标准的聚四氟乙烯导线固定。
美国专利US 4,275,469,Prosthetic Heart Valve,Gabbay S披露了一种具有大致均匀剖面的或多或少为管状的僧帽瓣,其与上面提到的Deac专利相似,但是具有一个用以形成瓣膜开口的延伸的单舌瓣。所述管件可以具有一根用以防止小叶脱垂的支承杆。瓣膜的材料本身是生物性的并且其设计不能模拟天然瓣膜。不具有索。管件通过传统的缝合术直接固定至至乳突状肌肉上。
德国专利DE4234127 A1(Heart Valve Prosthesis,ReichartB&Vetter H)披露了一种能够借助塑料补片固定在心脏壁上的分配僧帽瓣。所披露的僧帽瓣由从人或动物中获取的天然僧帽瓣获得。将一个塑料补片(最好为PTFE)放置在乳突状肌肉的头部上(带有天然瓣膜的切除的剩余物)作为植入辅助器。天然的索是完整的并且所述固定不限制在受体心脏的乳突状肌肉部位上。利用一根导引针,将一根塑料线穿过小叶,从缝制环向下导引至在固定点处的塑料补片,还可以加强生物组织。此处所描述的瓣膜实质上是一种移植的天然瓣膜,其具有一些保护和支承组织的附加物。
本发明的目的在于提供一种改进的心脏瓣膜假体。
发明概述
根据本发明的第一个方面,提供了一种心脏瓣膜假体,其包括:
一个适于与僧帽环相配合的支承件;
一个瓣膜件,其与所述支承件相配合并可以在打开位置和闭合位置之间移动;
至少一个连续元件,其一端与所述支承件相连以及另一端与乳突状肌肉相连;以及
约束装置,其用于将连续元件固定至心脏肌肉的一个区域上并且允许调节心脏外部的连续元件。
在使用中,本发明的一个显著优点在于:通过设置至少一个连续元件,能够维持乳突状肌肉和僧帽环之间的连续性,以便维持左心室的功能。另外,由于连续元件的调节作用,可以使连续性得到最佳。这种连续性的损失在除去病变僧帽瓣膜以及随后利用传统的假体心脏瓣膜进行更换的操作中是固有的。
根据本发明的第二个方面,提供了一种心脏瓣膜假体,其包括:
一个适于与僧帽环相配合的支承件;
第一和第二瓣膜件,这些瓣膜件与所述支承件相配合并可以在打开位置和闭合位置之间移动,这些瓣膜件限定弯曲的接合表面,每一表面均具有至少两个弯曲点;以及
至少一个连续元件,其一端与所述支承件相连而另一端适于与乳突状肌肉相连。
本发明的第二个方面提供了一种允许血流通过打开的瓣膜假体而流动的形式,尽管使用了比较坚硬的合成材料来形成瓣膜元件,但是,这种形式的瓣膜元件能够提供与天然瓣膜的打开流动区域相比的打开的流动区域。
所述支承件最好具有环状构件。所述支承件可以包括一个半刚性构件,并且可包括一种合适的金属。
可以方便地将所述支承件安装在一个织物缝制环。所述织物缝制环最好由聚四氟乙烯或类似物制成。这种缝制环有助于一旦已除去病变或有缺陷的瓣膜,便能将僧帽瓣膜假体缝制在心脏的僧帽口内。
优选设置多个瓣膜元件。这些瓣膜元件可以是柔性的,并且最好应能模拟体内工作的生物瓣膜的前侧和后侧小叶。假体最好包括两个形式为前侧小叶和后侧小叶的柔性瓣膜元件。最好所述瓣膜元件包括细长的加强件,所述加强件的形式可采用单丝或复丝(扭绞或编织)绳或纤维,最好采用坚固但具有柔性的生物兼容性材料,如聚四氟烯(PTFE)、聚丙烯或碳纤维。该绳通常绕支承件固定并且从该处呈辐射状分布。这些主加强绳可以通过辅助绳相互配合,这些辅助绳最好环绕所述主绳以形成网状结构。最好将该网植入形成瓣膜元件表面的柔性材料内或使其与这种柔性材料结合。可以根据与加强绳相匹配的柔性和机械特性选择所述材料。最好将所述网植入一种生物稳定的聚合物(例如,聚氨酯,聚丙烯)内或适合的生物聚合物内。所述网状构件的尺寸和形状对应于在体内发现的瓣膜小叶。
作为可选择的方案,可使用具有高纵横比的较短绳的不连续纤维,以便利用适当的合成材料(如聚砜、聚氨酯或碳纳米管)来提供小叶的辅助加强件。可以方便地利用适合的材料合成物的无纺织物,例如,碳纤维或以前提到的材料来加强小叶。
最好,将主加强绳植入柔性小叶材料的单一平面内或者在两个或更多单独的平面内构成所述加强带并且在其之间设置柔性聚合物材料,以便能够保护纤维免于因相邻纤维之间的磨损而产生长期损坏。
最好主加强绳伸出瓣膜元件并且具有适于连接至乳突状肌肉的端部;因此,这些绳能够起到所述连续元件的功能。因此,本发明的这种最佳形式能够模拟乳突状肌肉,索腱,僧帽瓣小叶和僧帽环之间的天然连续性。另外,本发明的这种最佳形式能够保持通过瓣膜并且在左侧心室内接近正常的血液流动,从而减小出现血栓栓塞的危险性并且能够减小出现与传统假体瓣膜相关的血栓栓塞的危险性。
心脏瓣膜假体可还包括一个用于接收连续元件另一端的管状件,以便连接至乳突状肌肉上。最好所述管状件采用刚性或半刚性结构,其由合适的聚合物材料或例如金属合金(如钛)或形状记忆合金(如镍钛诺)制成。所述管件的前端通常采用套针的形式,其适于被推动通过心脏肌肉(通常是乳突状肌肉的最厚部分)到达心脏的外侧。因此,管件通常出现在心脏的左心室的下部外表面。优选,所述管状件具有打开的网状结构,以允许组织向内生长并合拢,从而加强在索固定位置处的心室肌肉组织。更理想的是,瓣膜可以涂覆一种用以提高血液相容性的材料,例如水凝胶和含氟聚合物原浆。
本发明的瓣膜元件具有一种几何形状,该几何形状能模拟体内工作的生物瓣膜的前侧和后侧小叶的功能并且其最适于允许血液能有效地流过处于打开状态的瓣膜,而在瓣膜处于闭合状态时,保持封闭并且不产生泄漏。更理想的是,瓣膜元件的自由边缘包括一个或多个褶皱。最好,瓣膜元件在一个或两个瓣膜元件的自由边缘处包括切除区。可以方便地设置切除区以减小自由边缘处的压力,并且使因每一瓣膜元件在接合区相互磨耗所产生的瓣膜磨损降至最小程度。优选,切除区可适于一个小叶或者适用于在两个小叶中更换褶皱。
最好,利用三维仿形曲线构成瓣膜元件的自由边缘的设计。可以以方便的方式,利用6th级多项式方程限定自由边缘曲线的一半,当其以二维形式投影至标准的笛卡儿平面上时,其相对于中心平面对称。例如,笛卡儿平面为x-y平面,x-z平面以及y-z平面。中心平面为y-z平面。通常,对于例如为1-褶皱,2-褶皱,3-褶皱的任意方案而言,用于限定自由边缘曲线的6th级等式如下所示:
f(t)=at6+bt5+ct4+dt3+et2+ft+g
其中:t为一个点沿自由边缘曲线的x-,y-或z-坐标,f(t)为该点的函数,而a-g为系数。
所述假体可还包括约束装置,其用以将连续元件固定至选择的心脏的某一区域上。最好,约束装置包括一个可压缩的卷缩卡箍,该卡箍本身由一个垫圈约束。一般情况下,所述可压缩的卷缩卡箍和垫圈由一种聚合物或类似材料制成。在其它的方案中,可以采用其它形式的约束装置,它们包括其它的机械固定装置或非机械装置。
作为可选择的方案,约束装置可以与管状件一体形成。作为可选择的方案,约束装置可包括一个允许从心室内侧设置管状件的垫圈以及一个独立的垫圈,该垫圈是之后加设的以便从心室的外侧设置管状件。
在本发明的第三个方面,提供了一种插入心脏瓣膜假体的方法,所述心脏瓣膜假体包括一个适于结合至僧帽环的支承件;一个瓣膜件,其与所述支承件结合并可以在打开位置和闭合位置之间移动;以及至少一个连续元件,其一端与所述支承件相连以及另一端与乳突状肌肉结合,其中,所述连续元件伸出瓣膜元件并且包括绳,所述绳与天然瓣膜的索腱极为相似并且是可以分别调节的,所述方法包括以下步骤:
(i)将所述支承件固定至心脏的僧帽口上;
(ii)使所述连续元件通过心脏的乳突状肌肉;以及
(iii)将所述连续元件固定至所述乳突状肌肉上。
本发明的术语“心脏”意味着哺乳动物的心脏,特别是人的心脏。
在本发明的另一个方面,提供了一种插入心脏瓣膜假体的方法,所述心脏瓣膜假体包括一个适于结合至僧帽环地支承件;一个瓣膜件,其适于与所述支承件结合并可以在打开位置和闭合位置之间移动;以及至少一个连续元件,其一端与所述支承件相连以及另一端与乳突状肌肉结合,其中,所述连续元件伸出瓣膜元件并且包括绳,所述带与天然瓣膜的索腱极为相似并且是可以分别调节的,所述方法包括以下步骤:
(a)从患者体内切除病变的瓣膜,其中,乳突状肌肉的端部和在僧帽口处的小叶组织边缘在左侧是完整的;
(b)测量患者瓣膜腔的尺寸;
(c)确定在患者乳突状肌肉内部的适当位置以接收心脏瓣膜假体的连续元件;
(d)在确定的乳突状肌肉处刺穿患者的心脏;
(e)将所述支承件固定至心脏的僧帽口上;
(f)使所述连续元件通过心脏的乳突状肌肉;以及
(g)将连续元件固定至所述乳突状肌肉上。
可以推动一个管状件通过乳突状肌肉或另外将其设置在乳突状肌肉上以接收连续元件。最好,利用一根较长的针或其它适合的医疗装置在尽可能接近乳突状肌肉端部的预定位置处刺穿心脏,以接收连续元件。通常,使一根柔软的导引线通过刺穿的位置处并且可根据需要,将其用于导引扩张器通过,最终导引包括连续元件的管状件通过该位置。最后,将心脏瓣膜假体固定至适当的位置处,以模拟天然瓣膜。优选,通过将支承件缝合在心脏的僧帽口上来实现支承件的固定。其有利于通过将环绕所述支承件的织物缝制环缝合在心脏的僧帽口上来实现。更为理想的是,将支承装置缝合在僧帽环上。利用本领域已知的技术和/或根据外科优先选择和实际操作来实现缝合。
最好在位于心脏中时调节连续元件。应理解,本发明的术语“调节”意味着放松和张紧。通过在心脏仍打开的情况下,根据对瓣膜元件的检查进行初始调节,可实现对连续元件的准确调节。随后,在闭合胸腔之前,在心脏闭合且正常跳动的情况下,对连续元件的调节进行细微的调整。最好利用心回波描记术或一些其它的本领域技术人员已知的方法检验心脏瓣膜假体的功能。通过卷缩连续元件上的可压缩卷缩卡箍或其它约束件,可以保持连续元件的张紧,该卡箍位于乳突状肌肉的外侧。最好使卷缩卡箍靠近也设置在乳突状肌肉外侧上的垫圈或旋钮。在垫圈上的自然张紧有助于防止出血。
如上所述,通过对受者心脏的特定部位进行心回波描记控制,可以实现连续元件的张紧。其实质上有利于允许例如在瓣膜环的平面内对优选的瓣膜元件对的正常接合。换句话说,防止瓣膜元件脱垂入心脏的左心房内,还能够确保以充分的相互接触面积闭合。更为理想的是,通过以不会过分放松以致瓣膜元件脱垂入心脏的心房内的程度进行放松来调节连续元件。相反,张紧所述连续元件时应避免过度张紧,从而避免可能与瓣膜元件的接合产生干涉。
优选,设置多个连续元件,最好,各个连续元件或连续元件中的各个元件可例如由色标编码识别;其有助于可选择地张紧瓣膜元件和小叶的特定部分以实现最佳的小叶形状。
在本发明的另一个实施例中,可以使多个连续元件(它们通过跨过心脏肌肉壁的本发明的管状件)进一步通过横穿体壁的进出管件。当根据本领域熟知的外科技术,在打开心脏的手术之后,将被正常安装至患者时,可以使进出管件与胸腔排出管结合。其有助于允许从手术区的外侧适当地调节可独立识别的连续元件,以实现适当的张紧。可暂时卷缩连续元件,直至对连续元件的卷缩进行最终的调节。例如,通过环绕延伸通过进出管的连续元件的套索状绳,可以实现暂时的卷缩。最好使套索状绳靠近心脏的出口的点。最好,通过张紧或放松套索状绳(其经在与连续元件相同的进出管内的通道通向身体外侧)的端部,可以张紧或放松套索状绳。
通常,由外科医生手动进行连续元件的调节。作为可选择的方案,利用已知技术的心回波描记成象(例如,心回波描记成象法,经食道的(transoesophageal)心回波描记成象法或其它形式的成象法),有助于进行连续元件的调节。在闭合胸腔之前,可以在手术室中进行连续元件或所述连续元件的的各个绳或索的调节。通过调节在身体外侧的连续元件(其已通过横穿体壁的管件),在最初的手术后的几天,在闭合胸腔后,可有利于调节连续元件。其可避免重新打开胸腔壁并且直接在连续元件跨过心脏壁的位置处调节连续元件。
一旦实现在身体外侧的适当调节,便完成了连续元件的固定。利用任何适当的装置或机构,可以从身体外侧进行固定。例如,连续元件通过的心脏外表面上的旋钮可带有一个强弹性的C形卡箍,其由一个设置在卡箍端部之间的刚性部分保持打开。最好,一旦确实已进行了最终调节,通过进出管便取出该部分,结果,C形卡箍形成O形并且能够固定连续元件或其各个绳的位置。
一旦实现了心脏瓣膜假体中连续元件的固定,便可以分开多余的各个绳或索并将它们与通过体壁的管件一起除去。其实现方式可以采用:通过在无菌条件下、在皮肤附近打开进出管,切除各个绳的端部或索,并且在以传统的胸腔排出管所使用的方式,抽出进出管之前,将多余的索材料推入身体内部。
附图的简要说明
下面,将参照附图,通过例子说明本发明的实施例,其中:
图1为在心脏舒张(左心室舒张)期间,心脏左侧的示意图;
图2为心脏收缩(左心室收缩)期间,心脏左侧的示意图;
图3为由左侧心房所示的正常僧帽瓣的示意图;
图4为心脏的正常前侧小叶的示意图;
图5为心脏的正常后侧小叶的示意图;
图6,7和8为本发明一个实施例的瓣膜的示意图;
图9为图6中瓣膜的示意图,其进一步说明了一个心外约束垫圈和卷缩卡箍;
图10为固定至心脏的乳突状肌肉上的图6的瓣膜的示意图;
图11a-11d为本发明最佳实施例的心脏瓣膜假体的示意图,这些附图显示了在闭合位置且由利用三维仿形曲线构成的假体,所述三维仿形曲线显示了在(a)x-y平面,(b)y-z平面,(c)x-z平面以及(d)在后视图的假体;
图12a-12c为描绘三维仿形曲线的每一个平面的二维图,所述三维仿形曲线限定了图11中瓣膜的瓣膜元件的自由边缘,其中:(a)x-y平面,(b)x-z平面,(c)y-z平面;
图13a-13d为本发明实施例的心脏瓣膜假体的示意图,这些假体以闭合位置所示,由利用三维仿形曲线构成且在瓣膜的自由边缘设计中带有一个或多个褶皱,特别是,(a)基本的1-褶皱形状;(b)2-褶皱形状;(c)3-褶皱形状以及(d)在后侧小叶具有另外的切除部分的2-褶皱形状;
图14a和14b为在闭合位置所示的本发明一个实施例的心脏瓣膜假体的示意图,并且描述了
(a)闭合瓣膜的流入侧,以及
(b)闭合的瓣膜的流出侧;
图15为在打开状态下所示的本发明一个实施例的心脏瓣膜假体的示意图;
图16a和16b为在(a)闭合和(b)打开位置的本发明实施例的心脏瓣膜假体的示意图;
图17a和17b为在闭合状态下并由流出侧所示的本发明实施例的心脏瓣膜假体的示意图;
图18a和18b为在(a)闭合和(b)打开位置、由流出侧所示的本发明实施例的心脏瓣膜假体的示意图。
对附图的详细说明
首先参见图1,其显示了在心脏舒张(左心室4舒张)期间,健康人心脏2的左侧;僧帽瓣小叶6,7是打开的,以允许血液从左心房8流向左心室4,并且将小叶6固定至乳突状肌肉12上的索10是松弛的。
图2示出了在心脏收缩(左心室4收缩)期间的心脏2的左侧;僧帽瓣小叶6,7是闭合的并且使索10张紧(防止僧帽瓣小叶6,7脱垂至左心房8内并确保血液不会返回左心房8,反而使其注入主动脉14内)。
图3,4和5示出了正常的前侧和后侧小叶6,7。与后侧小叶7相比,前侧小叶6具有固定至环上的较小的固定件。每一小叶均具有固定至乳突状肌肉12上的主索腱10。
参见图6和7,这些附图示出了本发明一个实施例的心脏瓣膜假体20,并且示出了一个前侧瓣膜元件25,而图8还示出了后侧瓣膜元件24。
假体20包括一个形式为环26的支承件,其安装在一个织物缝制环28内。在该实施例中所示的缝制环2 8由聚四氟乙烯制成,并且如后面将描述的那样,有助于外科医生将心脏瓣膜假体缝合至心脏的僧帽瓣内。每一瓣膜元件24,25的特征均在于由环状支承环26伸出并固定在支承环26上的主加强绳30。绳30由强柔性材料(在该实施例中为聚四氟乙烯(PTFE))制成。主绳30由辅助绳32连接,以形成尺寸和形状均对应于相应的正常僧帽瓣小叶6,7的网状结构。将每一网状结构植入一个由柔性生物聚合物(在该实施例中为聚氨酯)制成的薄层34内。使用这种生物聚合物的优点在于在体内使用瓣膜时无需抗凝血剂。
加强绳30伸出瓣膜件24,25并且聚集在一起形成两个通过相应管件38的连续元件36。如将描述的那样,元件36往往能够起到与正常瓣膜的主索腱10相似的功能。每一根管38均具有一个有助于刺穿乳突状肌肉12的形式的前端40;管38采用套针的形式,其能够被推动通过心脏肌肉,最好能通过乳突状肌肉12的最厚部分。
参见图9,其示出了用于连续元件36的约束装置46,该装置在每一元件36上均包括一个垫圈48以及一个可压缩的卷缩卡箍50。约束装置46往往设置在心脏的外侧并且在使元件36通过管38时,能够接收连续元件38。
图10示出了固定至心脏的乳突状肌肉12上的心脏瓣膜假体20。可以理解:连续元件36由已被推动通过乳突状肌肉12的管38接收。
在使用中,通过由外科医生调节连续元件36的各条绳30的张力,可获得分别模仿心脏的正常小叶6,7的功能的前侧和后侧瓣膜元件25和24的最佳形状。可压缩的卷缩卡箍50能够相对于垫圈48约束所述绳,从而一旦适当地张紧连续元件36的绳30,外科医生便能着手进行卡箍50的压缩。
在心脏仍打开的情况下,根据对瓣膜元件25和24的检查,通过进行初始调节,可以实现连续元件36的准确张紧,并且利用用以使瓣膜实现其功能的心回波描记术,在闭合胸腔之前,在心脏闭合且正常跳动的情况下,可以很好地协调连续元件36的准确张紧。通过在使卡箍50卷缩之前,可选择地使连续元件36的各条绳或索张紧,由此实现跳动工作的心脏中的最佳小叶形状。
在垫圈48上的张力能够防止血流过管件38,并且对前侧和后侧瓣膜元件25和24的纤维强化处理分别允许在通过收缩的左心室4对扩张的瓣膜元件加载时,能够从扩张的瓣膜元件均匀地传递力。另外,通过假体20并且在左心室内均有近似正常的血流,甚至在僧帽处(在该处血流更复杂,其包括在左心室腔中的涡流)也有近似正常的血流。实际上,与传统的心脏瓣膜假体相比,由于这种更正常血流的结果,就会降低血栓栓塞的形成,从而降低了与假体瓣膜相关的血栓栓塞形成的危险性。重要的是,心脏瓣膜假体44能够保持正常的在左心室-环状的连续性,并能维护左心室的功能。通过连续元件36的可选择张紧,心脏假体的调节能力还允许例如,通过在手术台上进行心回波描记控制,为各个患者定制心脏瓣膜假体20。
为了清楚起见,图11~18所示的心脏瓣膜假体示出了在闭合状态下的假体,并且在瓣膜元件的前部和后部自由边缘之间具有较小的间隙;实际上,在闭合状态下,自由边缘是接触的。
图11a-11d示出了由三维仿形曲线所设计的本发明一个实施例的心脏瓣膜假体的各种视图。图11(a)示出了心脏瓣膜假体的x-y平面,所述心脏瓣膜假体包括一个前部瓣膜元件125,后部瓣膜元件124,缝制环128以及主加强件130。加强件130伸出瓣膜件124,125并且聚集在一起形成两个通过相应管件152的连续元件136。每一管件152均包括整体垫圈154,这些垫圈用于使管件相对于患者心脏的心室的内侧和外侧定位。
图13a-13d分别示出了本发明实施例的各种心脏瓣膜假体220,320,420,520,这些心脏瓣膜假体分别包括前部和后部瓣膜假体225,224,325,324,425,424,525,524并且显示了在自由边缘的一个或多个褶皱。图13(a)显示了瓣膜的基本形状,其最精确地模拟了天然瓣膜,并且包括一个褶皱254,以便每一个瓣膜元件224,225均限定有具有三个弯曲点的接合面。图13(b)显示了一种2-褶皱式设计,其具有两个褶皱354,356,以便每一瓣膜元件324,325均具有五处弯曲。图13(c)显示了一种3-褶皱式设计:第一褶皱454,第二褶皱456,以及第三褶皱458。图13(d)显示了一种2-褶皱式结构,其在后侧瓣膜元件524中具有第一褶皱554,第二褶皱556以及切除部分560。
图14-18显示了在自由边缘处具有一个或多个褶皱的本发明实施例的心脏瓣膜假体的各种视图。图14a和14b显示了1-褶皱式设计。图15的特征在于2-褶皱式设计。图16a和16b显示了一种假体,其特征在于单一的褶皱,但是在后侧小叶624中具有切除部分。应理解:在使用中,与图14中没有切除部分的1-褶皱小叶相比,在图16b的1-褶皱瓣膜的后侧小叶624中引入切除部分能够提供更大的孔口面积。其允许在闭合瓣膜时,在不会产生血液泄露的情况下,更多的血液能够流过该孔口。
图17a和17b分别显示了具有2-褶皱和3-褶皱形状的心脏瓣膜假体。图18a和18b显示了一种具有2-褶皱形状的心脏瓣膜假体,其在后侧小叶中带有切除部分。这些实施例的特征还在于具有类似网状结构的管状元件664,其有助于组织的向内生长。
在不脱离本发明保护范围的情况下,可对前面所述的实施例作出各种改进。
例子
在闭合位置的瓣膜结构的数学模型。
以数学形式模拟的僧帽瓣设计是以由伍德金属(Wood metal)模制成的本发明一个实施例的僧帽瓣的物理模型为基础。这些设计均是相对于中央线对称的,以便足以构成后侧和前侧小叶的一半,并且随后对它们进行镜像处理以形成这些设计。例如,后侧半个小叶(图11)按以下方式构成。首先,从中心线位置向与所述前部区域相交的接合处绘制环状周边曲线部分。随后,从环状曲线中心点处的直角上绘制中心线曲线。最后,绘制三维曲线以将中心线连接至接合处。该三维曲线为小叶的自由边缘的半个部分并且由三条二维界面曲线构成。利用这三条界面曲线,可以形成表示小叶半个部分的三维表面。对该表面进行镜像处理以形成所述小叶。以相似的方式构成前侧的半个部分。为了进一步沿小叶对曲线进行局部控制,可使用辅助导引或约束曲线。
1.自由边缘
利用三维仿形曲线构成僧帽瓣结构的自由边缘。由于仿形曲线通过三维区域,因此,难以获得对其进行确定的单一等式。已经限定了表示自由边缘曲线在投射至标准笛卡儿平面上时的自由边缘曲线的6th级多项式方程,即x-y平面,x-z平面,以及y-z平面。
这三个二维等式表示限定自由边缘的三维仿形曲线。这些等式表示小叶自由边缘的一半,其相对于中央平面(即,y-z平面)对称。
已将在三维仿形曲线上的点的(x,y,z)坐标绘制成表。每一个平面的二维图均准确地表示了图12所示的曲线。第6级多项式的趋势线由图表表示,并通过重新作出这些曲线的图表且与原始模型相比较,检验这些趋势线的等式。对于所述三个平面而言,在图12中表示了用于1-褶皱小叶设计的典型曲线。可以调节系数以使趋势线与原始模型的配合达到最佳。
对于任何实施例而言,表示所述自由边缘的通常的6th级等式为:
f(t)=at6+bt5+ct4+dt3+et2+ft+g
其中:t为一个点沿自由边缘曲线的x-,y-或z-坐标,f(t)为该点的函数,而a-g为系数。
所述6级等式允许一定设计范围的变化,并且可以在小叶的自由边缘设计中加入一个或更多的褶皱(从流出侧直视瓣膜,从x-y平面可以清楚地看到),切除部分(从x-z平面可以清楚地看到),或它们的任意结合。可以通过适当地改变等式的系数来设计曲线。例如,如图13所示,这些方案的四个例子是:(a)基本的1-褶皱形状;(b)2-褶皱形状;(c)3-褶皱形状以及(d)在后侧小叶具有辅助切除部分的2-褶皱形状。
为了清楚起见,在图13所示的所有设计均显示了后侧和前侧自由边缘之间的较小间隙。在实际中,这些设计表示瓣膜的闭合结构并且自由边缘将接触,因此,相应的多项式方程将是相同的。例如,在后侧小叶带有多个切除部分而前侧小叶没有切除部分的情况下,所得的等式将是不同的,并且前侧小叶保持没有切除部分的等式。可以对一个或两个小叶实施切除。
x-y平面
通过改进常规等式的系数,可以获得许多复杂的设计。下面的表格说明了表示1-,2-,3-褶皱的小叶设计的系数值:
系数 | 设计 | ||
1-褶皱小叶 | 2-褶皱小叶 | 3-褶皱小叶 | |
abcdefg | 0.009×10-5-3.35×10-50.0017-0.02780.1-0.199124.0 | -1.54×10-591.8×10-5-0.01950.1721-0.570.715.8 | 1.93×10-5-90×10-50.0133-0.054-0.150.3715.8 |
系数g的数值表示在中心线的y-坐标,即,其限定了在前侧环的最低点处,在y-方向偏置原点的距离。从该平面不能清楚地看到自由边缘的切除部分。切除部分的最佳观察平面为x-z平面。
x-z平面
下面的表格显示了在具有切除部分和没有切除部分的情况下,由x-z平面限定自由边缘等式的系数值。
系数 | 设计 | |
没有切除部分 | 带有切除部分 | |
abcdefg | -1.0×10-550×10-5-0.0090.0693-0.2650.32120.0 | 1.93×10-5-90×10-50.133-0.053-.020.1520.0 |
从该平面可以看到,具有多个褶皱的设计与具有一个褶皱的设计相似。并且,系数g表示离开原点的偏置,即,沿中心线,在z-方向的偏置距离。其等于自由边缘距离环的最大深度。
y-z平面
下面的表格显示了表示关于1-,2-,3-褶皱的小叶设计的实施例的自由边缘等式的系数值:
系数 | 设计 | ||
1-褶皱小叶 | 2-褶皱小叶 | 3-褶皱小叶 | |
abcdefg | 0.3×10-5-18.6×10-50.0043-0.0450.245-0.511.0 | 0.22×10-5-7×10-5-8×10-50.0155-0.070.2511.0 | -0.01×10-540×10-5-0.00070.01110.238-0.5611.0 |
系数g表示y-坐标,在该处曲线开始于环,即小叶的接合处。
可出现这样的情况,即:自由边缘曲线的一个或多个系数(a,b等)为零值,其会导致6th级等式的相关项趋向于零。
2.中心线的曲线
中心线的曲线沿z-方向、从环伸出以与自由边缘三维曲线的起始处交叉。对于后侧和前侧小叶而言,该曲线是大不相同的,但它们均仅处于y-z平面内,并且可通过表示二维曲线的单一等式限定。
并且,可以将该曲线表示为所述形式的6th-级多项式方程:
y=az6+bz5+cz4+dz3+ez2+fz+g
但是,该曲线通常并不复杂,并且对于大多数实施例而言,更大的项具有趋向于零的系数。下面的表格说明了适用于1-,2-,3-褶皱的小叶设计的后侧和前侧中心曲线的系数:
系数 | 设计 | |||
后侧小叶 | 前侧小叶 | |||
1-褶皱 | 2-和3-褶皱 | 1-褶皱 | 2-和3-褶皱 | |
abcdefg | 0.00.00.0003-0.0150.026-1.828.0 | 0.00.00.0005-0.0260.49-4.028.0 | 0.00.0-0.00120.058-1.027.50.0 | 0.00.0-0.00090.042-0.694.940.0 |
与前面的多项式方程一样,系数g的数值表示在与环交叉处的起始y坐标。因此,后侧曲线的起始位置位于环上的最大高度,即28。后侧曲线起始于原点。
3.约束曲线
如前面所提到的那样,三种界面条件足以形成小叶的表面,即,自由边缘曲线,中心线曲线,以及环的边界。通过引入多个导引或约束条件,曲线,可以实现对该表面内的区域的进一步控制。虽然从2D-3D并以任意的方向,它们可以采用任意数量的方位,但是,对于实际应用而言,它们仍通常与中心线曲线平行并且偏向于接合边缘。虽然它们类似于中心线曲线,但是在系数上将具有较小的变化,以计算出在环上的起始y坐标以及在自由边缘的端部位置。
僧帽瓣假体
插入的方法:
切去病变的瓣膜,包括前侧和后侧小叶以及索,留下乳突状肌肉端部和在僧帽瓣口无损伤部分处的小叶组织的边缘。与两个叉形件(它们起到用以对新索插入位置进行定位的导引件的作用)一起,使用由形状与假体的环形状相似的环构成的瓣膜筛选器来判断新假体的索插入点的适当尺寸、方向和位置。利用一根较长的针在尽可能靠近乳突状肌肉的预定腱插入点处刺穿心脏,从而允许使一根柔软的导引线从心脏的内侧通向外侧。其用于在需要时导引扩张器通过,并且最终使两根管插入,在固定缝制环之前,使新瓣膜的索通过这两个管。
根据外科医生的优先选择和实际操作,以其它人工心脏瓣膜所用的标准方式,通过将新瓣膜假体的缝制环缝合至心脏的僧帽环上,从而可以以适当的方位(模拟正常瓣膜的方位)固定新的瓣膜。
随后,使已通过管状插入件到达心脏外侧的两组人造索通过横穿体壁的管件(与常规使用的胸腔排出管件相似)。其允许大致从手术区域的外侧张紧所述索以使瓣膜假体的小叶在瓣膜环的平面内均匀闭合,同时不会过分松弛以致小叶脱垂至心房内或过度崩紧以致与小叶接合产生妨碍作用,如由外科医生所判断的那样。随后,在心脏的外侧暂时夹紧索,以保持其张紧直至进行最终调节。以所述标准方式完成所述操作。
判断瓣膜的方法:
通过利用心回波描述成象法,在瓣膜插入后,可以对瓣膜进行调整。借助(例如)经食道的(transoesophageal)心回波描记成象,在闭合胸腔之前,在手术室中进行这种调节,或者通过张紧或放松人造索、利用心回波描记成象(或其它形式的成象)在最初的手术后几天内进行这种调节。若需要实现由心回波描记成象术或其它成象术所限定的最佳小叶接合,则可单独或成组张紧或放松经管件(由外科医生插入)通向体外的索。一旦已实现最佳程度的张紧,则通过一个由身体外侧操纵的适当装置,将索固定至心脏的表面,并且与通过体壁的管件一起,分开并除去在心脏外侧的多余的索。
Claims (50)
1.一种心脏瓣膜假体,其包括:
一个适于与僧帽环结合的支承件;
一个瓣膜元件,其与所述支承件结合并可以在打开位置和闭合位置之间移动;
至少一个连续元件,其一端与所述支承件结合而另一端与乳突状肌肉结合;以及
约束装置,其用于将连续元件固定至心脏肌肉的一个区域上并且允许调节心脏外部的连续元件。
2.一种心脏瓣膜假体,其包括:
一个适于与僧帽环结合的支承件;
第一和第二瓣膜元件,这些瓣膜元件与所述支承件结合并可以在打开位置和闭合位置之间移动,这些瓣膜元件限定弧形接合表面,每一表面均具有至少两处弯曲;以及
至少一个连续元件,其一端与所述支承件结合而另一端乳突状肌肉结合。
3.根据权利要求1或2所述的假体,其特征在于:所述支承件具有一个环状结构。
4.根据在前权利要求中任意一项所述的假体,其特征在于:所述支承件包括一个半刚性结构。
5.根据在前权利要求中任意一项所述的假体,其特征在于:所述支承件安装在一个织物缝制环中。
6.根据权利要求5所述的假体,其特征在于:所述织物缝制环由聚四氟乙烯制成。
7.根据在前权利要求中任意一项所述的假体,其特征在于:所述瓣膜元件是柔性的。
8.根据在前权利要求中任意一项所述的假体,其特征在于:设有多个瓣膜元件。
9.根据在前权利要求中任意一项所述的假体,其特征在于:设有两个柔性瓣膜元件。
10.根据权利要求9所述的假体,其特征在于:所述瓣膜元件的形成和设置应能模拟体内工作的生物瓣膜的前侧和后侧小叶的功能。
11.根据在前权利要求中任意一项所述的假体,其特征在于:所述瓣膜元件包括细长的加强件。
12.根据权利要求11所述的假体,其特征在于:所述加强件的形式为细长的绳。
13.根据权利要求12所述的假体,其特征在于:所述绳为复丝。
14.根据权利要求11~13中任意一项所述的假体,其特征在于:所述加强件由聚四氟乙烯(PTFE)、聚丙烯以及碳纤维中的至少一种构成。
15.根据权利要求11~14中任意一项所述的假体,其特征在于:所述加强件绕所述支承件固定并且从该处辐射伸出。
16.根据权利要求11~15中任意一项所述的假体,其特征在于:所述加强绳植入所述瓣膜元件内的单一平面内。
17.根据权利要求11~15中任意一项所述的假体,其特征在于:所述加强绳位于至少两个独立的平面内,并且在其间具有聚合物材料。
18.根据权利要求15所述的假体,其特征在于:所述加强件包括沿一个方向延伸的主元件以及沿另一方向延伸的辅助元件。
19.根据权利要求11~18中任意一项所述的假体,其特征在于:所述加强件包括具有高纵横比的较短的绞合不连续纤维。
20.根据权利要求19所述的假体,其特征在于:所述高纵横比的较短的绞合不连续纤维为纳米管。
21.根据权利要求18所述的假体,其特征在于:通过辅助元件相互结合主元件以形成网状结构。
22.根据权利要求21所述的假体,其特征在于:所述网状构件与形成瓣膜元件的至少一个表面的柔性材料相结合。
23.根据权利要求21或22所述的假体,其特征在于:将所述网状构件植入一种生物稳定的聚合物内。
24.根据权利要求23所述的假体,其特征在于:所述聚合物包括聚氨酯。
25.根据权利要求21~24中任意一项所述的假体,其特征在于:所述网状构件的尺寸和形状与瓣膜元件相对应。
26.根据权利要求11~25中任意一项所述的假体,其特征在于:所述加强件伸出瓣膜元件并且元件的端部形成连续元件。
27.根据在前权利要求中任意一项所述的假体,其还包括:约束装置,其包括一个用于接收连续元件的另一端部分的管状件。
28.根据权利要求27所述的假体,其特征在于:所述管状件是一根至少是半刚性的管。
29.根据权利要求27所述的假体,其特征在于:所述管状件由一种金属合金制成。
30.根据权利要求29所述的假体,其特征在于:所述合金为钛。
31.根据权利要求29所述的假体,其特征在于:所述合金为镍钛诺。
32.根据权利要求27~31中任意一项所述的假体,其特征在于:所述管状件具有打开的网状结构。
33.根据权利要求32所述的假体,其特征在于:所述打开的网状结构适于允许组织向内生长。
34.根据权利要求27~33中任意一项所述的假体,其特征在于:所述管状件包括至少一个整体凸缘。
35.根据权利要求34所述的假体,其特征在于:所述整体凸缘包括一个网状结构。
36.根据在前权利要求中任意一项所述的假体,其特征在于:所述假体涂覆有一种可选择以提高血液相容性的材料。
37.根据权利要求36所述的假体,其特征在于:所述用以提高血液相容性的材料为水凝胶和含氟聚合物原浆中的一种。
38.根据权利要求28所述的假体,其特征在于:所述管的前端采用套针的形式,其适于被推动通过乳突状肌肉。
39.根据在前权利要求中任意一项所述的假体,其还包括:约束装置,其用于将所述连续元件固定至心脏肌肉的一个区域并且允许对心脏外部的连续元件进行调节。
40.根据权利要求39所述的假体,其特征在于:所述约束装置包括一个可压缩的卷缩卡箍。
41.根据权利要求39或40所述的假体,其特征在于:所述约束装置包括一个凸缘。
42.根据在前权利要求中任意一项所述的假体,其至少包括第一和第二瓣膜元件,这些元件具有限定至少一个褶皱的自由端。
43.根据权利要求42所述的假体,其特征在于:所述瓣膜元件在至少一个瓣膜元件的自由边缘处包括切除区。
44.根据权利要求43所述的假体,其特征在于:所述切除区设置在两个瓣膜元件中的交错褶皱中。
45.根据在前权利要求中任意一项所述的假体,其特征在于:利用三维仿形曲线构成瓣膜元件的自由边缘。
46.根据权利要求45所述的假体,其特征在于:将具有至少一个褶皱的自由边缘曲线限定为:
f(t)=at6+bt5+ct4+dt3+et2+ft+g
其中:t为一个点沿自由边缘曲线的x-,y-或z-坐标,f(t)为该点的函数,而a-g为系数。
47.一种插入心脏瓣膜假体的方法,所述心脏瓣膜假体包括:一个支承件;一个瓣膜元件,其与所述支承件结合并可以在打开位置和闭合位置之间移动;以及至少一个一端与所述支承件结合的连续元件,所述方法包括以下步骤:
(i)将所述支承件固定至心脏的僧帽口上;
(ii)使所述连续元件的另一端通过心脏的乳突状肌肉;以及
(iii)调节在心脏外部的连续元件。
48.一种插入心脏瓣膜假体的方法,所述心脏瓣膜假体包括:一个支承件;一个瓣膜元件,所述瓣膜元件与所述支承件结合并可以在打开位置和闭合位置之间移动;以及至少一个一端与所述支承件结合的连续元件,所述方法包括以下步骤:
(a)从患者体内切除病变的瓣膜,其中,乳突状肌肉的端部和在僧帽口处的小叶组织边缘保留不动;
(b)测量患者瓣膜腔的尺寸;
(c)确定在患者乳突状肌肉内部的适当位置以接收连续元件;
(d)在确定的乳突状肌肉处刺穿患者的心脏;
(e)将所述支承件固定至心脏的僧帽口上;
(f)使所述连续元件通过心脏的乳突状肌肉;
(g)调节在心脏外部的连续元件;以及
(h)将连续元件固定至所述乳突状肌肉上。
49.根据权利要求47或48所述的方法,其还包括以下步骤:
闭合患者的胸腔;随后,调节所述连续元件。
50.根据权利要求47,48或49所述的方法,其还包括以下步骤:单独调节连续元件的绳。
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GBGB0125925.8A GB0125925D0 (en) | 2001-10-29 | 2001-10-29 | Mitral valve prosthesis |
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Also Published As
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EP1439800A2 (en) | 2004-07-28 |
WO2003037227A2 (en) | 2003-05-08 |
WO2003037227A3 (en) | 2003-10-16 |
US20050075727A1 (en) | 2005-04-07 |
CA2464744A1 (en) | 2003-05-08 |
GB0125925D0 (en) | 2001-12-19 |
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