CN1190175C - 瓣膜成形用假体 - Google Patents

瓣膜成形用假体 Download PDF

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CN1190175C
CN1190175C CNB001037749A CN00103774A CN1190175C CN 1190175 C CN1190175 C CN 1190175C CN B001037749 A CNB001037749 A CN B001037749A CN 00103774 A CN00103774 A CN 00103774A CN 1190175 C CN1190175 C CN 1190175C
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valvoplasty
ring
artificial body
core silk
silk
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CN1269201A (zh
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W·马尔佐兹
R·考夫曼
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GEOSTRA MEDICAL TECHNOLOGY Co Ltd
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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
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • A61F2/2448—D-shaped rings
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility

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  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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  • Prostheses (AREA)
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Abstract

本发明涉及一种用于二尖瓣和三尖瓣的心脏瓣膜的瓣膜成形用假体，其形状是一环(1)，该环(1)具有一在环平面内分区段的不同弯曲柔韧性的芯丝(10)，其特征为，该环(1)的形状是一开口环或是一关闭至一间隙的环，该环(1)被分成在运动主平面内具有不同弯曲柔韧性的三个区段(2，3，4)。

Description

瓣膜成形用假体
技术领域
本发明涉及一种用于二尖瓣和三尖瓣的心脏瓣膜的瓣膜成形用假体，其形状是一开口的或关闭至一间隙的环。
背景技术
在心脏瓣膜机能不全时采用瓣膜成形用假体来避免植入一人造的心脏瓣膜。瓣膜成形用假体的使用可能与瓣膜的修复、乳头状腱束的缩短或移位或者乳头肌的缩短结合在一起。
房室环是一动态结构，它在心动周期中改变其大小和形状。在收缩期间，尤其是二尖瓣的中间环的直径由于后环收缩而减小，而前环长度几乎保持不变。如果出现收缩的前环运动(systolic anteriormotion，SAM)，此外存在太大的后瓣尖的话，则可能会导致左室流出束的阻塞。(left ventricular outflow tract obstruction，LVOTO)。
首先，非狭窄引起的搏出量的损失属于用瓣膜成形术可治疗的机能不全症。上述搏出量的损失是由相应心房中血液通过二尖瓣或三尖瓣瓣膜的过高的收缩期的回流引起的。对于这些机能不全可能有慢性原因，如瓣膜脱出、左右室扩张、肺动脉扩张过度或损害三尖瓣瓣膜功能的左室瓣膜疾病。这些症状例如是由风湿性发热、冠状疾病、环的钙化、马方氏综合症、乳头肌功能缺陷和狼疮引起的。然而对于这些机能不全可能也有急性原因，例如由于乳头腱束破裂(粘液瘤、心内膜炎、创伤)和乳头肌破裂(梗塞、创造)以及瓣尖穿孔(心内膜炎)而致的瓣膜脱出。
最近，二尖瓣或三尖瓣瓣膜通过植入一瓣膜成形假体的修复旨在形成一尽可能宽的瓣尖互适应面和在收缩期减轻组织负荷以及在舒张期有良好的血液动力性。这些包括校正环的扩张和/或变形，有选择地还原瓣尖已变形的部位以及预防重复扩张和变形。迄今为止使用刚性的或柔性的二尖瓣修复环(carpentier-或Duranringe)来还原二尖瓣膜的环，从而提高关闭性能。刚性瓣膜成形用假体，如在US-A3656185中所公开的，其特征是有高的形状稳定性。相反，柔性的瓣膜成形用假体则具有周期性变形的优点。它显示出高的结构扭转性和极小的圆周扩张性。这保证了对房室环明显的组织减荷。计算机模拟和用三维回波心动图检查法的实际测量已明显证明柔性环相对于较长期以来已知的刚性瓣膜成形用环具有优点。在收缩期加压的整个瓣膜面积减少约25％(Kunzelmann K.S.等写的文章“用于僧帽瓣阀的环形扩张的柔性和刚性瓣膜成形术的比较：一种有限元模型”-杂志Heart Valve Dis.1998；7，1：108-116和YamauraY等写的文章“在病人身上装有瓣膜成形用的环的僧帽瓣环的形状和动态的三维回波心动图的评价”-杂志：Heart Valve Dis.1997；6.1：43-47。)
相反，对于舒张期心室充盈要比完全刚性的瓣膜成形环具有更大的房室开启面积和更小的流入阻力。在植入柔性的瓣膜成形环后，出现SAM-综合征也要比植入刚性环后明显少得多。然而，周长上完全柔性的瓣膜成形环的缺点是，在植入后首先在连合区域出现瓣尖的周期性的折叠运动和膨胀。上述植入必须在已减荷的和静止的环旁进行。
发明内容
本发明旨在提出一种瓣膜成形用假体，它具有柔性瓣膜成形环的优点而没有其缺点。
上述目的是用一个二尖瓣和三尖瓣的心脏瓣膜的瓣膜成形用假体来完成，其形状是一环，该环具有一在环平面内分区段的不同弯曲柔韧性的芯丝，其特征为，该环的形状是一开口环或是一关闭至一间隙的环，该环被分成在运动主平面内具有不同弯曲柔韧性的三个所述区段。
具有不同柔性区域的瓣膜成形用假体虽然已由WO97/16135所公开，但是这一柔性是由或多或少地打开的环形断面来达到。然而，本发明的瓣膜成形用假体既可以是封闭的环，也可以是打开的环，但都具有要求的柔韧性。因此，芯丝在中间部即后二尖瓣瓣尖范围可以具有高的弯曲柔韧性，在瓣膜连合范围可以具有高的弯曲刚度。这例如可以如此实现，即芯丝在其整个长度上具有不同剖面的区段。其中，不同剖面连续或不连续地相互过渡。
已知柔性瓣膜成形环的周期性变形和已知刚性瓣膜成形环的良好的形状稳定性按简单的方式通过本发明瓣膜成形环芯丝的区段成型的机械性能而结合在一起。
如果芯丝由统一的材料制成，则有特殊的优点。芯丝的断裂可靠性要比接合的芯丝更容易控制。作为芯丝的材料尤其考虑金属或合金，最好是钛合金。这里，芯丝最好可以由圆形丝或多边形丝制成。然后，芯丝的不同剖面可以由丝的冷压加工制成。通过丝的冷变形，丝具有比热变形更高的韧性。
该丝至少部分可以具有一大体矩形的横截面，其中，横截面的高度和宽度在丝的长度上变化。根据丝的压平方向，柔韧性克服力的作用在环平面内变化。如果芯丝在瓣膜成形环的径向只具有小的厚度，则整个环在这一区域是很容易弯曲的。相反，在环平面压平的芯丝导致芯丝高的径向刚度，因此，瓣膜成形环在这些区域只允许小的弯曲。通过改变剖面高度与宽度的比例可以相对于来改变的剖面改变芯丝的平面惯性矩至40％。
在一有利的实施例中，芯丝由一生物兼容的包皮例如一由膨胀的聚四氟乙烯制成的软管包覆。在芯丝和包皮之间可以设置一例如由聚酯织物制成的垫层。
如果该环从环平面沿着血液通流方向向前即沿心房方向拱起，则有其它的优点。
附图说明
下面借助于附图进一步说明本发明瓣膜成形环的一个优选实施例。其中：
图1开启的瓣膜成形环的主平面视图；
图2图1的瓣膜成形环从下方看去的视图；
图3沿着图1的瓣膜成形环的剖面线III-III的剖面；
图4沿着图1的瓣膜成形环的剖面线IV-IV的剖面；
图5沿着图1的瓣膜成形环的剖面线V-V的剖面；
图6表示轴向平面惯性短与比例H/B有关的曲线；
图7在心脏瓣膜舒张期形状时与图1相应的瓣膜成形环的视图；
图8在心脏瓣膜收缩期形状时瓣膜成形环的与图7相应的视图；
具体实施方式
图1中C形瓣膜成形环1具有一对称轴22。该轴22与通过最大环形扩张区域延伸的轴5垂直相交。轴5和对称轴22位于运动主平面。瓣膜成形环1为了通过心脏外科容易定位在其端部6，在最大环形扩张部位7和在对称轴22的交接处8设有标记。标记6、7、8例如可以由染色的、编结的聚酯缝合线制成。线16表示瓣膜成形环的中性纤维的走向，在弹性变形时不承受延伸。该线是几何控制力，用来计算瓣膜成形环1的区段的面积惯性矩。
图2表示瓣膜成形环1从主平面沿血液通流方向向前拱起，即沿心房方向凸起。图2中的轴9与图1中的轴5和2正交，并沿Z方向表示。在该方向上平面惯性矩为Iz。
图1中的环1在运动主平面内被分成不同弯曲柔韧度的区段2、3、4。环1在对称设置的区段2中具有最大的刚度，在区段4内具有最小的刚度。区段3是平均刚度的区域。不同的刚度是通过环1内部所含的芯丝10实现的，该芯丝在区段2、3和4中具有不同的剖面。这表示在图3～5中。芯丝10由一圆形丝构成，图4所示的圆形横截面形状在区段3中保持不变。
图3表示瓣膜成形环1(图1)针对动力主平面中的力加固的区段2的剖面。对称轴14a和15a平行于轴9或主平面定向。它们始终与中心线16正交和它们自己相交。通过瓣膜成形环1的芯丝10的剖面10a的高度H与宽度B的比例形成要比不变的图形剖面10b要高的面积惯性矩Iz，如图6所示。上述高度与宽度的比例例如可以在0.35～1之间。这样相对于作用在主平面内的外力具有较大的刚度。在所示的实施例中，区段成形的芯线10由一由膨胀的聚四氟乙烯制成的软管13包覆。作为由膨胀的聚四氟乙烯制的外包皮11下的垫层12可以采用聚酯织物。
在图4中表示了瓣膜成形环1具有未改变的芯丝横截面区段3的剖面。对称轴14b和15b平行于轴9(图2)或平行于主平面(图1)定向。它们也正交于中心线16延伸并相互相交。通过瓣膜成形环1的芯丝剖面10b的高度H与宽度B的比例产生比区段2中要小的面积惯性矩Iz(图6)和相对于作用在主平面内的外力要小的刚度。
在图5中表示了瓣膜成形环1在高的柔韧性的区段4(图1)中的剖面。对称轴14c和15c又平行于轴9(图2)和平行于主平面定向。它们同样正交于中心线16延伸和相互相交。芯丝剖面10c具有高度H与宽度B大的比例，例如在1～2.86之间，从而与图4中未改变的剖面10b相比形成较小的面积惯性矩(Iz)和相对于作用在主平面内的外力较小的刚度。
在图6中表示了在直径为1.2mm的压平的圆形丝的实施例中与高度-宽度比例H/B有关的轴向面积惯性矩(Iz)的内插的曲线。内插法是基于三个测得的、可由圆形丝的冷变形制成的H/B比例(参见图6曲线中的点23、24、25)。
对于未变形的区段3中的圆形丝(图1和图4)，H＝B＝芯丝的直径，Iz用下式计算(点24)：
Iz圆形＝0.049·B4
对于区段2中的加固的芯丝(图1和3)可产生最小的比例H/B＝0.35，因此，Iz可按下式近似给出(点23)：
IzRechteck＝0.083·H·B3
对于区段4中(图1和图5)局部柔韧的芯丝可制成最大的比例H/B＝2.86，因此，Iz(点25)同样可以如点23一样近似计算。
具有从圆形丝至冷变形的四边形丝的几何横截面过渡的面积惯性矩Iz在0.35≤H/B≤2.86和未变型的材料的预定丝的直径D为1.2mm时允许按普通内插公式计算(图6)：
Iz＝D·(-0.214+0.225·e0.287·B/H)mm4
在其它丝的直径时，所使用的指数函数的参数必须用新的控制点(23、24、25)重新计算。
图7表示在舒张期在二尖瓣17的环上的瓣膜成形环1。该瓣膜成形环1如同其植入时一样没有受到主平面中的力的作用，具有未变形的中心线16。
相反，图8表示本发明的瓣膜成形环1的二尖瓣实施柔性适配于前心脏瓣尖21和后心脏瓣尖22的收缩期形状，因此有最佳的互适应线26。中心线16柔性弯曲成新的形状18。后瓣尖20上的区段4(图1)承受最大的形状改变。瓣膜成形环1的最大的刚度位于相对的区段2中的互适应线26两端的连合区域。两端的弯曲宽度19可按下式给出：
           Δs＝λ·q·14/(E·Iz)
其中，E是芯丝材料的弹性模量，q(1)是作用在主平面的周向负荷，它从组织经过接缝作用到环上，1是从轴22看去的中心线的长度，λ是与中心线的几何形状有关的比例系数。

Claims (11)

1.用于二尖瓣和三尖瓣的心脏瓣膜的瓣膜成形用假体，其形状是一环(1)，该环(1)具有一在环平面内分区段的不同弯曲柔韧性的芯丝(10)，其特征为，该环(1)的形状是一开口环或是一关闭至一间隙的环，该环(1)被分成在运动主平面内具有不同弯曲柔韧性的三个所述区段(2，3，4)。
2.按照权利要求1的瓣膜成形用假体，其特征为，所述区段(2，3，4)在所述芯丝(10)的整个长度上具有不同剖面。
3.按照权利要求2的瓣膜成形用假体，其特征为，不同的剖面(10a，10b，10c)连续或不连续地相互过渡。
4.按照权利要求1～3中之一的瓣膜成形用假体，其特征为，芯丝(10)由一种统一的材料制成。
5.按照权利要求4的瓣膜成形用假体，其特征为，芯丝(10)由金属或钛合金制成的丝制成。
6.按照权利要求5的瓣膜成形用假体，其特征为，芯丝(10)由一圆形丝或一多边形丝制成。
7.按照权利要求6的瓣膜成形用假体，其特征为，芯丝(10)的不同的剖面(10a，10b，10c)由冷压加工的丝制成。
8.按照权利要求6的瓣膜成形用假体，其特征为，芯丝至少部分具有一矩形的横截面(10a，10c)，其中，横截面的高度(H)和宽度(B)在芯丝的长度上是变化的。
9.按照权利要求1～3中之一的瓣膜成形用假体，其特征为，芯丝(10)被一生物兼容的包皮(11)包覆。
10.按照权利要求9的瓣膜成形用假体，其特征为，在芯丝(10)和包皮(11)之间设置一由聚酯织物制作的垫层(12)。
11.按照权利要求1～3中之一的瓣膜成形用假体，其特征为，环(1)从环平面起沿着血液通流方向沿心房方向凸起。
CNB001037749A 1999-03-09 2000-03-09 瓣膜成形用假体 Expired - Fee Related CN1190175C (zh)

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DE19910233A1 (de) 2000-09-21
EP1034753A1 (de) 2000-09-13
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ATE289186T1 (de) 2005-03-15

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