CN1223562A - 人造二尖瓣心脏瓣膜 - Google Patents

人造二尖瓣心脏瓣膜 Download PDF

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CN1223562A
CN1223562A CN97195809A CN97195809A CN1223562A CN 1223562 A CN1223562 A CN 1223562A CN 97195809 A CN97195809 A CN 97195809A CN 97195809 A CN97195809 A CN 97195809A CN 1223562 A CN1223562 A CN 1223562A
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wall
heart valve
pillar
mitral heart
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CN1143659C (zh
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约瑟弗·詹森
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Adiam Medizintechnik GmbH and Co KG
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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

本发明涉及一种人造二尖瓣心脏瓣膜,它由一个带基环的支承壳体(stent)构成,基环支承两个基本上朝基环轴线方向的、通过圆弧形的、用来固定两个柔软的帆的壁连接的支柱,支柱的自由端构成帆的内托架。为了避免心脏和瓣膜潜在的相互功能损害,基环(12)－在顶视图内看—具有一个封闭的、具有一个共同的纵轴(15),及两个但是不同大小的横半轴(16,17)的非圆形状,其中支柱(18,19)位于纵轴上,并构成从一个半形到另一个半形的过渡部位,其中具有较小曲率的壁(13)支承比具有较大曲率的壁(14)相对于基环底面成更大倾角设置的面积小的腔壁的帆(11)。

Description

人造二尖瓣心脏瓣膜
本发明涉及一种人造二尖瓣心脏瓣膜，由一个带基环的支承壳体(stent体)，它支承两个基本上朝环轴线方向的、通过弧形的、用来固定两个软帆的壁连接的支柱，其自由端构成帆(Segel)的内托架。
这种二尖瓣心脏瓣膜借助于一个固定在基环上的缝合环缝在身体组织内。
第一个按现有技术状况的二尖瓣心脏瓣膜具有圆管形瓣膜壳体，其中设有二个帆，其中一个具有从圆柱体表面截下来的形状，在闭合状态它们相互支承，而在开启状态则靠在瓣膜壳体的圆柱形壁上。如在DE 2742 681 B2中已经提到过的那样，这种心脏瓣膜的闭合能力不是很好。其次需要比较长的瓣膜壳体。这里为了得到改进，在上述资料中建议，代替两个帆仅仅采用一个膜片，它相当于椭圆柱表面被一个圆柱体切下来的部分。瓣膜壳体应该做成由椭圆柱和一个90°角相交的圆管，其中膜片沿这个截交线的半个周边固定在相当于开头所述的支柱的两个端点之间。在这种结构形式时，虽然由于放弃使用两个帆可防止在闭合状态下两个相互靠在一起的帆的折皱，但是由此可能无法防止瓣膜的不充分闭合。
在人造心脏瓣膜中变化的生理学载荷状态以不同的闭合压差的形式显现出另一个问题，它必须与心脏瓣膜相匹配。由于这种闭合压差径向分力通过帆作用在开头所述的支柱上，由此它径向向瓣膜中心变形。当闭合压差增大时帆可能逆流动方向凹陷，相互内陷，并沿其自由边缘相互贴合，这可能导致帆的完全叠合，从而按希望的那样使瓣膜封闭，但是在压差很大时，也可能造成帆自由边缘过大的重叠，从而产生不希望的帆折皱。为了减小与stent体尖端相邻的、相当于天然连合的帆的上部区域很大的应力，已经建议，支柱在上部设计成柔性的，但是这可能导致不希望的蠕变现象，从而造成过早的材料疲劳。为了限制支柱向内沿瓣膜轴线的径向变形，在DE4222610A1中建议，支柱的自由端做成刚性的，特别是通过材料的积聚支柱自由端内形成棱柱形内托架，它的横截面呈三角形。棱柱形内托架应该朝stent-基底，亦即朝心脏瓣膜的入口区域中凹形收缩。
本发明的目的在于：通过新的造型和一种新的设计结构将开头所述的二尖瓣心脏瓣膜改进到这样的程度，使得避免心脏和瓣膜潜在的对功能的相互损害。
这个目的通过按权利要求1的人造二尖瓣心脏瓣膜来解决，本发明的瓣膜的特征是：基环-在顶视图内看-具有一个具有共同纵轴的、但却有两个不同大小横半轴的封闭的非圆形状，其中支柱位于纵轴上，并构成从一个半形到另一个过渡部位，其中具有较小曲率的壁与具有较大曲率的壁相比，支承一个相对于基环底面设置得具有更大倾角的表面较小(腔壁的)帆。因此两个半形构成一个stent体，它非常接近于具有D形或腰形形状的天然二尖瓣瓣膜。在这方面例如在US-A-5415667中所谓的无stent生物学二尖瓣瓣膜与按本发明的二尖瓣心脏瓣膜相比有这样的区别：主动脉的(aortal)帆配属于较小曲率的帆的一侧，而腔壁的帆位于具有较大曲率的区域内。半形可以是半椭圆，双曲线或其他形状，其中作为边界条件特别是应该保证：两个半形的交接点是连续可微的。
对于倾角较小的主动脉的(aortal)帆来说由帆与壁的上内棱边的连线确定的分别相对于基底的帆倾角最好在25°到45°之间，而对于倾角较大的(腔壁的)帆则在40°到65°之间。倾角较大的帆至少比倾角较小的帆的倾角大5°。
按照本发明的另一种结构造型主流动方向相对于腔壁的帆的法线倾斜10°至25°，最好是倾斜15°。通过这一措施减小支承壳体和收缩的心室内壁受干扰的危险和可能出现的损害。帆形成一个具有与主动脉瓣(Aortenklappe)相比较小开口横截面的明显的漏斗形开口通道。所述结构造型保证生理学最合理的从前庭到心室的流道。此外所示的按本发明的心脏瓣膜可以制造出比按现有技术状况已知的结构更小的结构高度。特别对于在横截面内是圆形或对称的椭圆形支承壳体是这样。
在一种优先的结构形式中支承壳体半椭圆横半轴长度之比为1.5至2.5∶1。特别是在半轴比为2∶1时可以达到完全按天然二尖瓣构造的形状。
支承壳体的两个不同半椭圆的共同的纵轴长度在10mm到45mm之间。
支柱最好厚度相同地内置在壁内，亦即支柱相对于壁突出不很多，而是壁在上述支柱区域内向上延伸到末端，尤其是形成一个尖的或削平的支柱末端。
如原理上已经在DE4222610A1中说明的，作为一种选择方案支柱可以做成前面所说的棱柱形结构。支柱向其自由端方向逐渐加厚成为所谓的端面尺寸，尤其是连续地加厚。相反支柱朝基底方向楔形地逐渐收缩，其中它在入口区，亦即在基环底边的前面通过向那里的基环壁厚过渡而终止。
为了防止支承壳体在帆开合时随出现的压差而变形，在支柱之间的区域内，即在帆底处的基环的壁厚大于在支柱附近区域，尤其是厚度选择得大1.4至2.3倍。
为了防止瓣膜帆在连合区内受到太大的负荷，按照本发明的另一种结构造型帆与壁的上内棱边的连线在每一侧都这样地布置，使它位于一个平面内。通过这种用于固定帆的壁一端面的结构造型避免太大的应力。
如果支承体的支柱这样地设置，使其纵轴大改沿主流动方向，即相对于基底倾斜0°至20°，可以在流通横截面，结构高度和其稳定性方面进一步改善二尖瓣心脏瓣膜。
用所述的二尖瓣心脏瓣膜与由现有技术状况已知的结构相比可以避免多方面的与结构和材料有关的风险。通过按本发明的二尖瓣心脏瓣膜的结构达到更接近于天然二尖瓣瓣膜的结构造型。与作为二尖瓣瓣膜代用品的、按经验在50％的情况下使患者需要服用防凝固药物的生物假体不同，按本发明的人造二尖瓣瓣膜可以不需要药物维持工作，因为它通过与帆的定位、开口横截面以及流动方向的结合所建立的流道大大降低了对血液的机械损害。
在附图中表示本发明的一个实施例。其中表示：
图1．人造二尖瓣心脏瓣膜的透视图，
图2．按图1的心脏瓣膜的俯视图，
图3．沿A-A线的剖视，
图4．另一种人造二尖瓣心脏瓣膜的透视图，和
图5．按图4的心脏瓣膜的俯视图。
人造二尖瓣心脏瓣膜由一个带两个帆11(Segel)的支承壳体10组成。支承壳体10借助于一个在瓣膜环内的缝合环23缝在患者组织内。支承壳体10由一种热塑性塑料如尼龙，例如通过注塑制成一个弯曲弹性小的物体，接着配上聚氨酯外涂层。整体的支承壳体10具有一个基环12，它的内棱边按现有技术状况已知的方法直至外表面倒圆。为使缝合环23更好地固定基环在外壳面上可以有一个凸耳。基本上垂直于基环底面的壁分为具有较小曲率的第一壁13和一个具有较大曲率的第二壁14，在朝基底的俯视图内看它们形成两个具有共同纵轴15的半形。按此两个横半轴16和17长度不同，它们的长度比最好是1∶2。直到在基环区域内也许有的凸耳为止壁13和14的外壳面是弯曲的，但却是光滑表面弯曲。相应地除后面还要说明的支柱18、19以外对于壁13、14的内表面也是这样。
壁13和14的壁厚是不同的，并向支柱附近区域逐渐减小，或者说在中间区域最大，在支柱之间的中间区域的壁厚最好是在支柱附近区域的两倍。帆固定在其上面的壁13和14的上端面向外倒斜，并直到支柱区域为止基本上展布成交线的形状，此交线由各个半形和一个与此成一个斜角的平面相交产生。为了粘接预制好的帆，帆与壁13和14的上内棱边的连线在一个平面内，它对于壁13的上棱边而言相对于基环底面成一个约56°的角分布，对于壁14的上棱边而言成一个41.5°角分布。但是端面也可以与一个平面相切，有关的帆在闭合状态下占有此平面。壁13和14的上内棱边在一个各自以不同的角度安装的平面内的结构提供了这样的优点：两个帆可以由一个平面形塑料膜片切割成，并可以无拉应力地或者无形成折皱的危险地粘贴在直到支柱附近区域的壁的上棱边上。
作为帆的材料可以考虑按现有技术状况已知的塑料膜片，尤其是热塑性弹性体或具有弹性体性能的塑料膜片，帆最好由柔软的聚氨酯膜片制成。
支柱18和19均匀加宽形成它的上端面20，在支承壳体10内壁的顶视图中看支柱做成V形，并楔形地终止于基环底面之上支承壳体10的入口区域内。支柱纵轴21相对于基环底面不是垂直分布，而是相对于表面法线略微倾斜，例如形成一个65°角。支柱的端面20相对于基环底面也有一个最好是15°的相应倾斜。支柱18、19或其端面20代替在天然瓣膜中有的连合帆，并以其大致等边的三角形的边作为帆11的内托架，在等边三角形的边到壁13和14的过渡区内支承壳体倒成圆角。帆11在壁板13和14上棱边外与支承壳体粘接在一起，并这样地相接，使得它在闭合状态下在等边支柱侧边处和位于支柱18和19之间的区域内几乎直线形地贴合在对面的帆上。由支柱18和19造成的连合区防止帆的击穿渗漏(durchschlagen)，并与沿纵轴15分布的帆11的重叠区一起用作帆的支承。由于帆11在壁13和14上的直到连合区的连线位于同一个平面内造成帆11和支承壳体10之间力的均匀分布，特别是有效地避免在支柱端部或支柱附近区域内很大的径向拉应力，这种拉应力在按现有技术状况已知的结构中导致支承壳体材料的疲劳，所谓的蠕变(Kriechen)。
支承壳体10的结构与天然的D形或腰形形状完全吻合，其中腔壁(Mural)帆以较陡的安装角装在壁13的上棱边上，而主动脉的(aortale)帆以较平缓的安装角装在壁14上。由此得到二尖瓣心脏瓣膜的较小的结构高度，它的主流动方向不是同心分布，而是与此倾斜15°分布。
图4表示二尖瓣心脏瓣膜的可供选择的结构形式，其中上面所述的支柱完全不再以实体形式出现。而是在这种结构形式中支柱等厚地(deckengleich)内置在壁23内。壁在相对的一端上向上延伸直到形成端侧的支柱末端24，支柱末端可以是尖的，或者如图所示是倒平的。
从基环到壁的上棱边壁厚d可以连续地减小，如由图5可以较清楚地看到，壁23的厚度d，在基环高度方向测量，在支柱区域内最小并逐步增加到一个最大值。在这个具体实施例中厚度尺寸为d1 2.57mm，厚度尺寸d2 2.34mm和厚度尺寸d3(在两个支柱区域)1.4mm。
在制造所述心脏瓣膜时各自制好的帆可以通过粘接或焊接固定在支承壳体的端面上。此外作为一种选择也可以借助于按现有技术状况已知的注塑方法包括双组分注塑制造心脏瓣膜，其中首先制造支承壳体，接着通过注塑在它上面做上帆。另一种可能性是应用所谓的浸润技术(Tauchtechnik)。为此例如由尼龙制成的支承壳体在涂上聚氨酯以后套在一个具有帆形状表面的相应浸润芯轴上，接着浸润芯轴连同支承壳体浸入液态的塑料溶液(聚氨酯)内，一直摆动，直至达到所希望的厚度分布。在摆动过程中塑料硬化。
本发明还延伸到人造血泵(人工心脏)，血管瓣膜植入、生物假体或机械假体之类，其中支承壳体是管状壳体或软管的一体组成部分。

Claims (13)

1．人造二尖瓣心脏瓣膜，由一个带一个基环(12)的stent支承壳体(10)组成，基环支承两个基本上朝基环轴线方向的、通过圆弧形的、用来固定两个柔软的帆(11)的壁(13、14)连接的支柱(18、19)，其自由端构成帆(11)的内托架，其特征在于：
基环(12)在顶视图内具有一个封闭的、带一个共同纵轴(15)，和两个但是大小不等的横半轴(16,17)的非圆形状，其中支柱(18,19)位于纵轴(15)上，并构成从一个半形到另一个半形的过渡部位，其中具有较小曲率的壁(13)比具有较大曲率的壁(14)支承一个与基环底面成更大倾角设置的表面较小的腔壁的帆(11)。
2．按权利要求1的二尖瓣心脏瓣膜，其特征在于：对于倾斜较小的主动脉的帆而言由帆(11)与壁(13,14)上内棱边的连线位置确定的帆各自相对于基底的倾角在25°到45°之间，而对于倾斜较大的腔壁的帆而言倾角在40°到65°之间，同时倾斜较大的帆比倾斜较小的帆的倾角至少大5°。
3．按权利要求1或2的二尖瓣心脏瓣膜，其特征在于：主流动方向相对于腔壁的帆的法线倾斜10°至25°，最好是15°。
4．按权利要求1至3之任一项的二尖瓣心脏瓣膜，其特征在于：横半轴(16,17)长度之比为1.5至2.5∶1。
5．按权利要求1至4之任一项的二尖瓣心脏瓣膜，其特征在于：共同的纵轴(15)长度在10mm至45mm之间。
6．按权利要求1至5之任一项的二尖瓣心脏瓣膜，其特征在于：支柱等厚地内置在壁(23)内。
7．按权利要求6的二尖瓣心脏瓣膜，其特征在于：端侧的支柱末端成尖端或削平延伸。
8．按权利要求1至7之任一项的二尖瓣心脏瓣膜，其特征在于：从基环到壁的上棱边壁厚(d)减小，最好是连续逐渐地减小。
9．按权利要求1至5之任一项的二尖瓣心脏瓣膜，其特征在于：支柱(18,19)朝其自由端方向加厚成为端面尺寸，最好是连续加厚。
10．按权利要求9的二尖瓣心脏瓣膜，其特征在于：支柱(18,19)到基底表面为止并在基底前入口区域内终止地楔形缩小。
11．按权利要求1至10之任一项的二尖瓣心脏瓣膜，其特征在于：基环(12)在支柱(18,19)之间区域内壁(13,14)的厚度，即帆的底部处的厚度大于支柱附近区域，最好大1.4至2.3倍。
12．按权利要求1至11之任一项的二尖瓣心脏瓣膜，其特征在于：帆(11)与壁(13,14)上内棱边的连线各自位于一个平面之内。
13．按权利要求3至12之任一项的二尖瓣心脏瓣膜，其特征在于：支柱纵轴(21)大致沿主流动方向分布。
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JP2000513248A (ja) 2000-10-10
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BR9709967A (pt) 2000-02-15
CA2258967A1 (en) 1997-12-31
DE19625202A1 (de) 1998-01-02
EP0910313B1 (de) 2003-11-05
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US6086612A (en) 2000-07-11
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