CN105188610A - 多股热定形瓣膜成形环 - Google Patents
多股热定形瓣膜成形环 Download PDFInfo
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- 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
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- 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
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Abstract
一种用于心脏瓣膜环修复的瓣膜成形术修复段。在一个实施方式中,对于三尖瓣和二尖瓣二者,多股索替代实芯丝。索允许用于微创外科手术(MIS)植入物的更大的展开柔性,同时仍保持所需的强度和实芯丝相似的拉伸性质。标准索提供在x-y平面中具有足够柔性的MIS瓣膜成形环,以允许外科医生将环挤压进小切口,比如能够穿过18Fr或更小的导管,同时在由心动周期施加于植入环上的力下维持结构刚性。使用热定形过程固定瓣膜成形环的特定形状。
Description
相关申请
本申请根据35U.S.C.§119(e)要求在2013年3月14日提交的临时申请号61/784,010的优先权。
技术领域
本发明一般地涉及心脏植入物,并且具体地涉及柔性瓣膜成形环,其具有热定形为期望形状的成股(stranded)芯构件。
背景技术
在脊椎动物中,心脏是具有四个泵送室的中空肌肉器官:左和右心房以及左和右心室,每个都提供有其自身的单向瓣膜。天然的心脏瓣膜被确定为主动脉瓣、僧帽瓣(或二尖瓣)、三尖瓣和肺动脉瓣,并且每个都被固定在瓣环(annulus)中,所述瓣环包括直接或间接地连接至心房和心室肌纤维的致密纤维环。每个瓣环限定流动孔口。
人工瓣膜成形环被用于修复或重建损坏或病变的心脏瓣膜环。瓣膜成形环被设计为支持在心动周期期间发生的功能变化:维持小叶(leaflet)接合和瓣膜完整性以防止逆流,同时在顺流期间允许良好的血流动力学。瓣膜成形术技术可以协同其它修复技术一起使用。环部分地或完全地围绕瓣膜,并且可以是刚性的、柔性的或选择性柔性的。
尽管二尖瓣修复和置换可成功地治疗许多患有二尖瓣闭锁不全的患者,但是当前使用的技术伴有显著的发病率和死亡率。大多数瓣膜修复和置换手术需要胸廓切开术,以便进入患者的胸腔。心脏内的外科手术常常需要使用心肺转流机(cardiopulmonarybypassmachine)将心脏和冠状动脉血管与动脉系统其余部分隔离和将心脏功能停滞。使用具有大胸骨开口的开胸技术。经历这样技术的那些患者通常具有瘢痕化收缩、瓣膜小叶的撕裂或融合以及瓣膜下结构(subvalvularapparatus)的紊乱。
自然地,手术患者希望以最少量地侵入身体进行手术。近来,为减少与传统开心瓣膜置换手术相关联的创伤和风险已进行了大量的研究。特别地,微创外科手术(MIS)和经皮外科手术领域自20世纪90年代早期至中期已进行了探索,其中多个装置现在被提出在无需打开胸腔的情况下能够实现瓣膜修复,并且一些甚至不需要旁路。借助内窥镜或其它这样的可视化技术,经由被引入通过胸部中一个或更多个小进入切口的细长管或插管,完成提出的MIS心脏瓣膜修复手术。例如,参见Cosgrove的美国专利号6,602,288。这样的微创手术通常以较少的疼痛和身体创伤为患者提供较快的恢复,从而减少医疗费用和对患者生命的整体破坏。微创方法也通常导致更小的切口,并且因此导致更小的瘢痕化,这是吸引大多数患者的美学优势。
所需要的是用于实施减少当前技术所伴随的创伤、风险、恢复时间和疼痛的心脏瓣膜修复的装置和方法。
发明内容
本申请提供包括柔性编织索(braidedcable)的瓣膜成形环,所述柔性编织索以闭合或开放的形状围绕环的整个外周延伸。本文公开的瓣膜成形环可具有包括多股编织索的柔性芯构件。期望地,多股编织索在横截面中具有至少七个编织索,并且可包括编织在一起的至少两种不同金属的股(strands)。
在一个实施方式中,对于三尖瓣和二尖瓣瓣膜二者,多股索替代实芯丝(solidcorewire)。索对于微创外科手术(MIS)植入物允许更大的展开柔性,同时仍维持所需的强度和实芯丝的相似拉伸特性。索导致MIS瓣膜成形环在x-y平面中具有足够的柔性以允许外科医生将环挤入1cm×1cm的切口,同时在由心动周期施加于植入的环上的力下维持结构刚性,并且允许不对称的偏转被设计到产品中。内芯构件的大部分长度具有第一弹性模量,其足够柔性而使得芯构件能够从其松弛的环形状压缩为适于通过管状进入装置的狭窄形状。
在本发明的一个实施方式中,考虑用于形成瓣膜成形环的方法,其包括提供由编织金属索形成的柔性芯构件。该芯构件保持为瓣膜成形环的期望的外周形状,并且然后加热超过它的奥氏体终点温度(austeniticfinaltemperature)。维持该温度一段时间,并且然后迅速地冷却芯构件。围绕柔性芯构件添加缝线可透过的(suture-permeable)外罩以形成瓣膜成形环。金属芯构件优选地由多股编织索形成,所述多股编织索是由缠绕成多股编织物的多个丝股形成的,其中多股编织物被编织成多股编织索。在一些实施方式中,多股编织索在横截面中具有至少七个多股编织物,并且具有足够的柔性以使得它能够被操纵成为细长的形状以适合在小的管状进入装置内。芯构件的外周形状可以是闭合的或开放具有两个自由端的,并且如果是开放的,则方法可包括加帽或焊接两个自由端以覆盖单个股末端。编织金属索可以由MP35NLT或镍钛合金(Nitinol)制成。
可以提供保持夹具(夹紧装置,holdingfixture),该夹具具有基底构件和至少一个夹紧构件。基底构件和夹紧构件具有互补的槽,它们一起提供用于瓣膜成形环的期望的外周形状的三维模具。保持芯构件的步骤包括将芯构件放置在基底构件和至少一个夹紧构件之间。在一些情况中,瓣膜成形环的期望的外周形状是开放具有两个自由端的。在这样的情况中,保持夹具优选地具有三个夹紧构件:第一个用于芯构件的闭合侧,并且其它两个用于两个自由端。首先使用第一夹紧构件并且第二和第三使用两个其它夹紧构件,将夹紧构件顺序地放置在芯构件上。
瓣膜成形环的期望的外周形状可以是三维的,并且基底构件和三个夹紧构件具有凸起的区域,以便于槽限定三维的外周形状。在一些情况中,夹紧构件栓至基底构件以将芯构件稳固地保持在槽中。
在另一个实施方式中,提供了包括柔性芯构件的瓣膜成形环,所述柔性芯构件包括编织金属索。该索由通过下述已经被热定形的金属形成:暴露于在其奥氏体终点温度之上的温度一段时间以引起晶体结构从马氏体改变为奥氏体,以及引起降低奥氏体-马氏体转变温度的变化,以便于分子在室温下处于奥氏体相。芯构件优选地成形用于二尖瓣或三尖瓣植入,并且包括围绕柔性芯构件的缝线可透过的外罩。
在一个实施方式中,瓣膜成形环的芯构件限定了具有后部和前部二者的马鞍形状,所述前部由从左侧和右侧向上上升的两个自由端限定。芯构件可在两个自由端上包括帽或焊接点以覆盖单个股末端。
在一些实施方式中,芯构件由多股编织索制成,所述多股编织索是由缠绕成多股编织物的多个丝股形成的,其中多股编织物被编织成多股编织索。多股编织索在横截面中具有至少七个多股编织物,并且具有足够的柔性以使得它能够被操纵成为细长的形状以适合在小的管状进入装置内。金属芯优选地由MP35NLT或镍钛合金制成。
参考说明书的其余部分和附图,本发明的性质和优势的进一步理解将会变得显而易见。
附图说明
图1是示例性的开放瓣膜成形环的透视图,其在二尖瓣环处植入并具有延伸显著超过连合(commissure)标记物的自由端;
图2A和2B分别是图1中所示的示例性瓣膜成形环的平面和立面图;
图3A-3C分别是由热定形编织索形成的图1的瓣膜成形环的示例性内芯构件的后面、前面和侧面立面图;
图4是沿图2B的线4-4截取的通过示例性瓣膜成形环的剖视图;
图5是沿图3B的线5-5截取的通过瓣膜成形环内芯构件的剖面图;
图6A和6B分别是示例性内芯构件的平面和后面立面图,所述内芯构件具有用于闭合二尖瓣瓣膜成形环的编织索;
图7A和7B分别是示例性内芯构件的平面和后面立面图,所述内芯构件具有用于闭合的不对称二尖瓣瓣膜成形环的编织索;
图8A和8B分别是示例性内芯构件的平面和中隔立面图,所述内芯构件具有用于开放的三尖瓣瓣膜成形环的编织索;
图9A是来自图3A-3C的芯构件的透视图,所述芯构件可见与用于在热定形程序期间将芯保持在期望形状的示例性夹具分解;
图9B是装配的用于在热定形程序期间将芯保持在期望形状的夹具的透视图;
图10A-10G显示出可以使用的多种不同的可能编织索配置;
图11A是闭合环的芯构件的示意图,所述芯构件被挤压为细长的形状并穿过递送管;和
图12A和12B是开放环的芯构件的示意图,所述芯构件被延伸为细长的形状并穿过递送管。
具体实施方式
本发明提供许多不同的瓣膜成形环或修复段。应当理解的是,术语瓣膜成形环或修复段指的是可连接至天然(native)瓣膜环并在瓣环修复中使用的任何大体上细长的结构,不论是直的或是弯曲的。例如,瓣膜成形环常规被理解为提供完整的或基本完整的圈(loop),其尺寸被设置为纠正畸形的和/或扩张的天然瓣环,并且其缝合于或以其它方式连接于纤维瓣环,瓣膜小叶自所述纤维瓣环延伸。在许多情况下,部分环或甚至直的修复段可仅仅围绕部分瓣环比如围绕后缘使用。
图1和2A-2B中图解了本发明的第一实施方式,其中二尖瓣瓣膜成形环20限定了后部22和前部24,所述前部24具有跨越缺口隔开的自由端24a、24b。按照惯例,瓣膜成形环20有些类似开放的D形,其中向外凸出的后部22和自由端24a、24b一起限定基本直的前部,所述前部大体在瓣环的连合处或可能是三角之间延伸。瓣膜成形环20通常包括下面更详细描述的缝线可透过的外罩26,用于使用缝线将环连接至瓣环。
有必要说明关于二尖瓣解剖学的词语。二尖瓣包括包围二尖瓣的大约三分之二周长的后小叶PL的和占据大约三分之一的瓣环周长的前小叶AL,二者在二尖瓣环MA处连接于它们的外部周围。这两个小叶的传统表示法显示后小叶在前小叶下方,它们在流动流中的接合线或接触线如微笑形曲线。二尖瓣连合处限定了明显的区域,其中前小叶和后小叶在它们的插入瓣环处联合在一起——其可以被想象为微笑形接合线的转角。事实上,二尖瓣瓣膜成形环20包括连合标记物28,其帮助外科医生记录或放置环在围绕二尖瓣环MA的适当位置处。标记物28可以是彩色螺旋线,而外罩26通常是白色织物。来自激光打印系统的油墨、调色剂或甚至编织为布的纱也可被用作标记物。可在环的后部22的中点处提供第三标记物30。
二尖瓣环的前部连接至纤维三角,并且通常比后瓣环对撕裂更有抗性且更少可能拉伸或延长。右纤维三角RT是二尖瓣、三尖瓣、主动脉环的无冠状瓣和膜性中隔之间的致密连接区域。左纤维三角LT位于主动脉瓣和二尖瓣的左纤维边界的连接处。尽管三角和连合处是互相紧邻的,但是它们不是处于精确相同的位置。事实上,因为三角的坚韧的纤维性质,示例性瓣膜成形环20的自由端24a、24b延伸基本上越过连合标记物28,进入三角RT、LT的区域。在优选的实施方式中,自由端24a、24b中的每个延伸越过各自的连合标记物28(并且因而越过天然连合处)长度L,在图2B中其指示为大约7-9mm之间。
参阅图2B的后面立面图,并且还参阅图3A-3C中所示的立面图,将描述瓣膜成形环20的三维轮廓,并且特别是内芯构件40。芯构件40为环20提供了骨架,并且仅仅覆盖有贴合其形状的柔性硅氧烷和/或织物。因此,将参考芯构件40的形状描述瓣膜成形环20的形状。芯构件40具有整体马鞍形,具有后部22和通过自由端24a、24b从左和右侧42向上上升在之间限定的前部。尽管在自由端24a和24b之间存在缺口,但是它们通常限定朝向彼此延伸的向上倾斜。自由端24a、24b的向上上升相当于邻近主动脉瓣膜的前瓣环,并且避免具有伸入左心室流出道内的结构,在所述左心室流出道中所述结构可能阻碍流出主动脉瓣膜。此形状还维护二尖瓣的前小叶的天然马鞍形,减小收缩期间对二尖瓣小叶的应力。而且,可在自由端24a、24b之间画出通常平滑且连续的虚构延伸,并且限定了比后部22的上升弧(upwardarc)上升更高的上升弧,比如图2A-2B中以虚线所示的。芯构件40的前部和后部22的相对高度在图3C的侧面立面图中是最明显的。
在这一点上,为用于限定环形状的各种方向定义坐标轴是有益的。这些定义被包括以帮助本领域普通技术人员理解环在体内和体外二者中的几何结构。关于图解的环和其它非圆形或非平面的环的术语“轴”或“中心轴”44指的是大体垂直于环的线,当在平面图(即,图2A)中查看时,其穿过环的面积质心(areacentroid)。“轴的”或“轴”的方向还可被视为平行于瓣膜孔口内血流的大致方向,并且因而当环被植入其中时平行于环内血流的大致方向;如本领域普通技术人员已知的,血流正常地以正向从右心房通过三尖瓣并进入右心室;血流正常地以正向从左心房通过二尖瓣并进入左心室。因而,换句话说,植入的瓣膜成形环围绕沿着通过瓣膜环的正常血流的平均方向对齐的中心流动轴(flowaxis)定向。尽管本发明的环通常是3维的且马鞍形的,但是其部分可以是平面的并垂直于流动轴。
因此,参阅图2A-2B和3A-3C,芯构件40的左和右侧42轴向地位于低点处,而后部22的中点在那一侧上轴向地上升至高点,并且两个自由端24a、24b上升至前部上的轴向高点。在低点和高点之间,芯构件40具有渐进曲线。芯构件40当处于其松弛的、无应力状态时成形为类似于可从加利福尼亚州Irvine的EdwardsLifesciences获得的Carpentier-PhysioIITM瓣膜成形环。如将在下面中清楚的,芯构件40的开放性质和从而形成的瓣膜成形环20允许外科医生将该结构打开成为细长股,用于递送通过如将在下面描述的小管,比如导管或插管。
图3A和3B图解了在芯构件40的自由端上形成的帽或焊接点46。这对帮助阻止梯度(gradient)的磨损,并且还对最小化末端处围绕的缝线可透过罩的磨耗来说是必要的。取决于材料,激光或等离子焊接可被用于在末端46处熔化和形成焊道(bead)。可选地,可首先焊接末端,然后是用于圆化或其它方式均平焊接点的型模(swagedie)(例如,Fenn型锻机)。可选地,平滑或圆化的帽可被焊接或粘合至末端。
图4和5分别显示了环20和示例性芯构件40的横截面。环20包括上述被缝线可透过界面50,比如硅橡胶管环绕的芯构件40。界面50紧密地环绕芯构件40,并且环绕界面50的是织物罩52。
如图5中所示的,图解的芯构件40期望地包括编织索,其具有在它们自身之中编织的编织股56的多个索54。此构造在本领域中也被称为多股编织索。在图解的实施方式中,编织图案包括19个单独的编织索54,其各自有七股56,或19×7图案。其它的多股编织物可能具有7×7、7×19、19×7或甚至7×7×7编织索。实际上,甚至可使用简单的索构造,比如1×3、1×7或1×19。这些可能的编织构造中的每个参见图10A-10G,并且将在下面更详细地描述。材料的一个实例是来自FortWayneMetals(FWM)的1058埃尔吉洛伊非磁性合金的索,其是具有0.062英寸(1.57mm)的总体直径的19×7股排列。另一个是MP35NLT(也来自FWM)的7×7的0.069英寸(0.175mm)直径股排列,其具有0.062英寸(1.57mm)的总体直径。
在图6A和6B中图解了瓣膜成形环芯构件的第二实施方式,其中柔性二尖瓣瓣膜成形环的芯构件60限定了后部62和前部64。如之前的,芯构件60类似具有向外凸出的后部62和基本直的前部64的D形。然而,与图3A-3B相比,芯构件60具有闭合的外周形状。包括芯构件60的瓣膜成形环也可以具有缝线可透过的外罩(未显示),比如环绕芯构件60的有机硅管,其然后被织物管环绕,比如图4中所见的。芯构件60当处于其松弛的、无应力状态时期望地具有与可从EdwardsLifesciences获得的Carpentier-Physio瓣膜成形环相同的形状。
在图7A和7B中显示了本发明的仍进一步的实施方式。柔性二尖瓣瓣膜成形环的芯构件70限定后部72和前部74。芯构件70具有改进的D形,其中向外凸出的后部72在右侧被内拉以便是非对称的。图7B显示了在76处向下下沉的后部的右侧。如同图6A-6B一样,芯构件70具有闭合的外周形状,但在此实施方式中,处于无应力状态,模拟也可从EdwardsLifesciences获得的Carpentier-McCarthy-AdamsIMRETlogixTM瓣膜成形环的形状。
图8A和8B显示了三尖瓣瓣膜成形环形状的仍进一步的芯构件80。如在较早的实施方式中,没有示出外部组件比如硅氧烷界面和织物罩以更好地图解柔性芯构件80。芯构件80包括具有两个自由端84a、84b的柔性编织索82。芯构件80在平面图中具有经典的三尖瓣形状,在第一自由端84a开始并以顺时针方向围绕第一段延伸,所述第一段在前小叶的主动脉部分中的点86处结束。邻近第一段的是对应于前小叶的其余部分的第二段,所述第二段在后间隔(posteroseptal)连合处88结束。最后,第三段90从后间隔连合处88延伸至第二自由端84b,其是沿着隔叶的中间位置(mid-way)。如图8B中所示的,第三段90相对于流动轴(未显示)向下成一角度。这些段的命名法取自围绕三尖瓣环的标准解剖学命名法。芯构件80当处于其松弛的、无应力配置时与可从EdwardsLifesciences获得的EdwardsMC3瓣膜成形术系统的形状相同。可选地,尽管未显示,但无应力配置可与Carpentier-Edwards理疗三尖瓣瓣膜成形环具有相同形状,比如2011年8月30日提交的美国专利公开号2012/0071970中所述,其内容在此通过引用明确地并入。
可用于本文所述的瓣膜成形环的芯构件的多种编织索具有很大程度的弹性和柔性,并且在任何特殊加工前,其不能够形成上面所述的三维环形状。也就是说,它们倾向于弹性回复为其原始的编织形状,即通常是线形的。因此,本申请考虑热定形芯构件以固定其中的特定的期望形状。热定形或更多的一般的热处理涉及升高金属芯构件的温度,同时使用夹具将它维持在环形的中性位置,在淬火和从夹具移出后保留该形状。更具体而言,施加的加热可引发“热记忆效应”,当材料被热处理以保持具体形式时,其本质上不同于原始的几何结构。在材料已经被加热、冷却和恢复至室温后,它将自然地保持受约束的形状。下面提供了该技术的一些术语,其中镍钛合金作为潜在的候选材料:
As(奥氏体起点温度):材料开始转化为奥氏体的温度。内部晶体结
构开始改变。对于镍钛合金,此改变正常地发生在500℃附近。
Af(奥氏体终点温度):材料已经完全地转化为奥氏体的温度。
加工的目的是使得芯构件材料在被加热至特定温度范围,比如从500℃至600℃一段时间后,保持其奥氏体形式。芯构件将被严格地以其期望的形状约束并被热处理。将金属暴露至奥氏体终点温度之上的温度一段时间以引起其晶体结构从马氏体改变为奥氏体,并且其奥氏体-马氏体转变温度被降低,以便于分子在室温下处于奥氏体相。热处理本质上“松弛”最初在材料内的应力,使得它不弹性回复为其未成形的形状。冷却应当是迅速的,以避免老化效应;例如可能需要水淬或空气冷却。加热的持续时间应当充足,以便于芯构件遍及其横截面达到期望的温度,这取决于保持夹具的质量、材料以及加热方法。
对在心脏植入物中使用的为良好候选的金属进行了多项研究。下面的表I指示了两种NiTi索样品的性能参数,所述样品在500℃-600℃的温度范围下在环夹具中加热。在表I中对应力消除的(STR)和未应力消除的(NonSTR)NiTi样品记录了所得到的形状保持性和其它相关注释。测试的NiTi由大约56%的镍和44%的钛组成。在热处理后从它们的新的中性位置拉伸环样品,并且释放以查看它们是否在热处理期间回到其约束的形状。这些测试揭示550℃的处理温度对任一种材料都导致良好的形状保持性。
表I-热处理镍钛合金(NiTi)的结果
除了NiTi样品的表征外,还使用由FortWayneMetals(FWM)研发的命名为MP35NLT的新合金的样品进行了热成形表征。MP35NLT是主要为镍、铬和钼的组合物。在500℃、600℃和700℃下处理样品。700℃显示出最大的形状保持性并证明MP35NLT也可以被热成形。
根据这些测试,NiTi和MP35NLT索二者都显示出希望。然而,虽然对永久变形具有高度抵抗性,但是NiTi索有可能在热成形期间损失它们的钝化层,这使得它与MP35NLT索类型相比成为次理想的索选择。一个可能性是为了特定的性能成果,由编织在一起的至少两种不同金属的股形成芯构件。NiTi是可以不需要编织构造以获得3-D形状的高度柔性材料,其可以弯曲以通过1cm的导管。另一方面,对于CoCr合金(例如,MP35NLT),编织结构是必需的。然而,MP35NLT与NiTi相比具有优异的抗疲劳性,其对于在大多数的患者剩余寿命(平均10-20年)来说在必须每年弯曲40000次的系统中是重要因素。因此,CoCr合金是优选的,其中MP35NLT是特别期望的。
在瓣膜成形环的优选的实施方式中,比如图3A-3C中所示的芯构件40被热定形以具有以下特性:
短轴对长轴的百分比比率是75%±10%。后部22的高度相对于长轴尺寸的百分比比率是5±2%。自由端24a、24b相距的距离或其间的缺口相对于长轴尺寸是52±5%。使用的材料是获取自FortWayneMetals的MPMP35NLT的7×7成股索。最后,环的成比例形状在具有24-44mm的标称尺寸的一组环上变化。首先,自由端24a、24b的高度相对于长轴尺寸的百分比比率对于24-28mm的环尺寸是5±3%,并且对于30-44mm的较大环尺寸是15±3%。同样地,平面图形状在一组环上变化,其中短轴对长轴的比率对30mm及以上的环尺寸优选地增大,以从大体D形变为更圆。
热定形芯构件40的示例性方法是将其放置在775摄氏度下的真空炉中的夹具中20分钟。然后,氩气充满腔室,持续最少一分钟。将芯构件留在保持夹具中并使用水淬火,然后移出并使其干燥。此时,将芯构件40的自由端焊接和/或加帽,并且将整个芯构件电解抛光。然后进行合适的清洁过程以确保自制造物(fabrication)去除任何金属颗粒。随后,如图4中所指示的,添加缝线可透过的罩。
图9A和9B图解了芯构件40的示例性保持夹具100的分解和装配的视图。夹具包括具有大体上矩形外周的基底构件102,并且在其中限定了保持芯构件40的槽104的形状。当然,芯构件40最初作为直的或略弯曲的索开始,并且被放置在正向(朝向读者)开始的槽104内。在基底构件102之上,显示了三个夹紧构件106和108a、108b。使用螺栓110等将夹紧构件106、108紧固至基底构件102。在芯构件40的近端侧坐落于槽104内后,将较大的夹紧构件106放置在其上,并固定至基底构件102。夹紧构件106覆盖基底构件102的大约一半面积。此时,芯构件40的自由端从基底构件102和正面(front)的夹紧构件106之间突出出来。较小的夹紧构件108a、108b是对称的,并且形状适合于每个压紧芯构件40的自由端之一。因而,每次一个下推每个自由端进入槽104的对应部分,并且将夹紧构件108a、108b中的一个固定至基底构件102。以此方法,装载芯构件40进入保持夹具100的过程是容易分段完成的。
应当注意的是,基底构件102具有为芯构件40的最终形状提供模具的三维轮廓。例如,基底构件102的前端110显示了轻微向上的弧,以便于可将相同的曲线给予芯构件40的后部。同样地,后端112具有凸起轮廓的特征,其可给予芯构件40的自由端向上的曲率。芯构件40的精确模具形状由大体遵照基底构件102轮廓的槽104所限定。尽管未显示,槽的相对一半被提供在夹紧构件106、108的下侧中,以便于芯构件40被环绕其整个外周大体圆柱形的槽围绕。这阻止了在热定形过程中的任何移动并给予芯构件40精确的形状。芯构件的热定形因此固定限定的最终形状中所期望的弯曲。
图10A-10G显示可以使用的大量的不同编织丝配置。这些包括:图10A中简单的1×3索、图10B中简单的1×7索和图10C中简单的1×19索。多股索包括互相编织的多条编织索,并且包括:图10D中7×7索、图10E中7×19索、图10F中19×7索和图10G中7×7×7索。这些索中的每个包括彼此缠绕的许多单个股,然而实芯丝由单股组成。即使对二者可以使用多种材料和合金,但是由于对不同股可以使用不同合金、可以使用不同股数和几何布置、和可以使用不同量的螺旋,所以索比实芯丝用途更多。这与仅可以使用单一合金的实芯丝的基本性质形成对照。因为这种独特的几何结构,索通常提供强度和柔性的更好的平衡。当从两端拉紧索时,由于不同股都沿相同方向被拉动,索与丝类似地起作用。然而,当弯曲索时,索中每个股的最外层表面上的应力与股的直径成比例。由于索中的每个股比具有相同总直径的实心丝小得多,所以弯曲应力和对弯曲力的抗性极大地减小。相比于相同总直径的实心丝,此差异为多股索提供了增加的柔性以及改进的疲劳性能。正是索的这种独特性质使其对于微创外科手术的瓣膜成形环而言成为实芯丝的有吸引力的替代物。有关医用级索的更多信息可从总部位于印第安纳州FortWayne的FortWayneMetals获得。特别地,一些索可以涂布有惰性聚合物以便具有更大的生物相容性。
应当理解的是,本文所述的成股索芯构件是足够弹性的,以便于从如所示的松弛形状被拉伸和加应力成为更线形的配置,用于递送通过进入管。本文所述的环因而具有松弛或无应力的形状,和有应力的递送形状。如附图中所示的无应力的形状一般描述了植入后的形状——尽管来自周围瓣环的外力可以少许偏转该无应力的形状。期望地,在允许环拉伸用于递送而同时能够以一定程度重塑与松弛形状一致的具体瓣环之间存在平衡。传统的重塑环包括更刚性的芯,比如固体钛(solidtitanium),而整体柔性环通常由硅氧烷/布组合或仅仅由PET或PTFE布组成,它们均不适合于本目的。实芯环不能变形以通过非常小的切口(例如1cm),而完全柔性的环不能给予纠正通常由疾病过程所变平的病理瓣膜中的解剖学结构的形状。结果,本环使瓣环恢复了三维正常解剖学形状,其可减少在天然小叶中可见的应力。
图11A示意性地图解了本申请的闭合的瓣膜成形环114的芯构件,所述芯构件被挤压为细长的形状以适合在管状进入装置116内。柔性索118有助于从D形转变为线形,使得环114可以通过进入装置116被引入至植入部位。进入装置114可以是插管或引导管或其它相似的权宜手段(expedient)。
图12A和12B示意性地图解了用于以微创方式递送具有芯构件120的瓣膜成形环的技术。因为芯构件120的开放性质,利用两个自由端,环可以在如图12A中所见的应力状态下相对直地打开或伸展,并且插入管状进入装置122内。可以将进入装置122插入通过患者胸部中的进入口,例如,使得其远端被定位在三尖瓣环处。芯构件120在图12B中被观察到正从进入装置122的一端排出,并且立即开始呈现其松弛的无应力状态。实践中,环将从进入装置122的远端排出以便于在大约适当的植入位置中呈现无应力的环形状,在这时,可使用缝线或钉将环连接至瓣环。
这些递送方法通过本文所述的多股索能够实现,所述多股索具有适应大量弯曲而不永久变形的柔性。期望地,本文所述的成股索环可以穿过具有18Fr、16Fr、14Fr或甚至更小尺寸的较少侵入性(less-invasive)的进入导管等。然而,索的缺点是其不容易永久成形为环。这个问题通过热定形芯构件以固定所期望的限定的弯曲而解决。
尽管本申请考虑使用简单的(即单一编织的)索和多股的(即多条编织物相互缠绕的)索二者,多股索被认为更适用于MIS递送方案。对于开放环,简单的索可能容易地线性拉伸以通过进入管,但是一旦被允许松弛并恢复瓣膜成形环形状,这些简单的索可能不具有瓣环重塑所必需的刚性。因此,更大量的弯曲将必须使用,这可能对整体环性能加以不期望的限制。而且,形成为闭合环的简单索不能在未扭结为永久弯曲的情况下挤压为线形形状。另一方面,多股索由于它们通常较小的单个股以及那些股相对于彼此滑动的能力而在弯曲方面更具柔性。而且,在开放环中,多股索在环平面中保持较大的刚性,以提供良好的重塑。并不是说简单的索从本申请排除,不通过小的进入口递送的瓣膜成形环可以由简单的索制成,其被热定形为特定形状并适当地进行。
FortWayneMetals索样品的初步评估
A.索样品的半定量分析
一系列索样品由FortWayneMetals(FWM)提供,所述索样品代表生物医学应用的典型标准产品。表II总结了样品的物理性质。应当注意的是,这些不是仅有的考虑的材料,合适材料的清单包括不锈钢合金、钛、钛合金、钴铬、镍钛合金(NiTi)和镍合金。进一步地,可利用这些各种材料的掺合物或组合获得具体的性能特性。排列的数量本质上是无限的。
表II-FWM提供的索样品
样品 | 材料 | 直径(英寸) | 股数 |
1 | Ti 6Al 4V ELI | 0.0375 | 19×7 |
2 | Ti 6Al 4V ELI | 0.0423 | 7×7 |
3 | L-605 | 0.0625 | 19×7 |
4 | L-605 | 0.080 | 7×7 |
5 | FWM-1058 | 0.062 | 7×19 |
6 | 316LVM | 0.078 | 7×7 |
7 | 316LVM | 0.0475 | 1×19 |
8 | 316LVM | 0.0425 | 1×7 |
9 | MP35N | 0.063 | 7×7 |
10 | FWM-1058 | 0.125 | 7×19 |
对这些样品进行初步的半定量分析以确定索材料、直径和股数的问题。通过将索样品弯回到其本身上直至永久变形发生或索股开始分离而在视觉上确定最小弯曲直径。在此方位,通过测径器进行测量。保持此最小弯曲直径所需的力通过在在实验室规模上索静止时手动施加必需的负荷来估计。此外,评估索样品的中度变形的最小弯曲直径(定义为移除负荷后索中保持的大约10度弯曲)以及“稳固性(robustness)”,这基于定性观察索能够经受住多少弯曲/变形而不遭受永久损坏(扭结、股分离或永久变形)。此初步分析的结果提供在表3中。
表III-对FWM提供的索样品的半定量分析的结果
样品 | 最小直径(mm) | 力(g) | 稳固性 | 变形直径(mm) |
1 | 6.9 | 48 | F | 4.8 |
2 | 9.5 | 130 | G | 6.5 |
3 | 14.9 | 228 | G | 9.4 |
4 | 25.4 | 460 | G | 13.7 |
5 | 12.1 | 185 | G | 8 |
6 | 20.4 | 560 | G | 12 |
7 | 16.2 | 480 | F | 10.7 |
8 | 22.8 | 580 | P | 20 |
9 | 17.6 | 385 | G | 9.9 |
10 | 16.5 | 410 | G | 10.5 |
表III中的结果可以针对用于MIS瓣膜成形环所必需的特征分类以鉴定良好(G)、可接受或普通(F)和差(P)的值。如先前所讨论的,理想的特性是索足够柔性来压缩用于递送通过导管,但在展开状态下保持刚性。鉴于此,具有<10mm的最小弯曲直径的样品被认为是良好的,而具有>20mm的最小弯曲直径的样品被认为是差的。虽然维持此弯曲直径的力不是索弯曲模量的直接度量,但它是合理的间接度量;由于此原因,>400g的任意值被认为是良好的,而<200g的任意值被认为是差的。一个明显的结果是,与较高股数的索相比,低股数的索(#7和#8)相对较不稳固。
在这些索样品中,样品2、3、9和10具有刚性、压缩性和稳固性的最佳整体相对组合。虽然形成具体索的选择建议是不成熟的,但定性观察和此数据表明,与7×7、7×19或19×7股数组合的小于0.08英寸的索直径最适用于瓣膜成形环应用。
B.索选择的考虑事项
FWM样品的初步评估与计算机模拟的结果一致,二者均表明多种索材料可被用于瓣膜成形环应用。由于最终的芯形状将规定给定索类型的有效模量,所以材料选择不受索材料固有刚性的约束。可能的索选择策略是:
·基于可得性/熟悉度选择材料。
·选择索直径与当前“实芯”环的直径相似。
·选择具有中等股数和低弯曲模量的标准现货供应索,以实现最大压缩来递送通过导管。
·如果局部最大位移太大,则以更大的股数重复。
因而,柔性索提供具有足够柔性以压缩来递送通过导管同时在展开状态下保持刚性的环。已经采用此策略构建原型(prototype)。也可能组合多种索类型来实现用于展开的高弯曲以及高展开后刚性的组合。
虽然上述是本发明的优选实施方式的完整描述,但是可以使用各种可选物、改进和等同物。而且,显而易见的是,某些其它改进可以在所附权利要求的范围内实施。
Claims (20)
1.形成瓣膜成形环的方法,其包括:
提供包括编织金属索的柔性芯构件;
保持所述芯构件处于所述瓣膜成形环的期望的外周形状;
加热所述芯构件超过其奥氏体终点温度并维持该温度一段时间;
迅速地冷却所述芯构件;和
围绕所述柔性芯构件添加缝线可透过的外罩。
2.权利要求1所述的方法,其中所述芯构件包括多股编织索,所述多股编织索是由缠绕成多股编织物的多个丝股形成的,其中所述多股编织物被编织成所述多股编织索。
3.权利要求2所述的方法,其中所述多股编织索在横截面中具有至少七个多股编织物。
4.权利要求1所述的方法,其中所述编织索具有足够的柔性以使得它能够被操纵成为细长的形状以适合在管状进入装置内。
5.权利要求1所述的方法,其中所述外周形状是闭合的。
6.权利要求1所述的方法,其中所述外周形状是开放的,其具有两个自由端。
7.权利要求6所述的方法,其中所述方法包括加帽或焊接所述两个自由端以覆盖单个股末端。
8.权利要求1所述的方法,其中所述金属是MP35NLT。
9.权利要求1所述的方法,其中所述金属是镍钛合金。
10.权利要求1所述的方法,进一步包括提供具有基底构件和至少一个夹紧构件的保持夹具,其中所述基底构件和夹紧构件在其中具有互补的槽,它们一起提供用于所述瓣膜成形环的所述期望的外周形状的三维模具,并且其中保持所述芯构件的步骤包括将所述芯构件放置在所述基底构件和所述至少一个夹紧构件之间。
11.权利要求10所述的方法,其中所述期望的外周形状是开放的,其具有两个自由端,并且所述保持夹具具有三个夹紧构件:第一个用于所述芯构件的闭合侧,并且其它两个用于所述两个自由端,并且其中所述方法包括首先使用第一夹紧构件并且第二和第三使用两个其它夹紧构件,将所述夹紧构件顺序地放置在所述芯构件上。
12.权利要求11所述的方法,其中所述期望的外周形状是三维的,并且所述基底构件和三个夹紧构件具有凸起的区域,以便于所述槽限定所述三维的外周形状。
13.权利要求11所述的方法,其中夹紧构件栓至所述基底构件以将所述芯构件稳固地保持在所述槽中。
14.一种瓣膜成形环,其包括:
包括编织金属索的柔性芯构件,所述索由通过下述被热定形的金属形成:暴露于在其奥氏体终点温度之上的温度一段时间以引起晶体结构从马氏体改变为奥氏体,并且引起降低奥氏体-马氏体转变温度的变化,以便于分子在室温下处于奥氏体相,所述芯构件被成形用于二尖瓣或三尖瓣植入;和
围绕所述柔性芯构件的缝线可透过的外罩。
15.权利要求14所述的瓣膜成形环,其中所述芯构件限定了具有后部和前部二者的马鞍形状,所述前部由从左侧和右侧向上上升的两个自由端限定。
16.权利要求14所述的瓣膜成形环,其中所述芯构件包括多股编织索,所述多股编织索是由缠绕成多股编织物的多个丝股形成的,其中所述多股编织物被编织为所述多股编织索。
17.权利要求16所述的方法,其中所述多股编织索在横截面中具有至少七个多股编织物。
18.权利要求14所述的瓣膜成形环,其中所述编织索具有足够的柔性以使得它能够被操纵成为细长的形状以适合在管状进入装置内。
19.权利要求14所述的瓣膜成形环,其中所述金属是MP35NLT或镍钛合金。
20.权利要求15所述的瓣膜成形环,进一步包括在所述两个自由端上的帽或焊接点以覆盖单个股末端。
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