CN1195460C - 假体的二尖瓣心脏瓣膜 - Google Patents

假体的二尖瓣心脏瓣膜 Download PDF

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CN1195460C
CN1195460C CNB018143555A CN01814355A CN1195460C CN 1195460 C CN1195460 C CN 1195460C CN B018143555 A CNB018143555 A CN B018143555A CN 01814355 A CN01814355 A CN 01814355A CN 1195460 C CN1195460 C CN 1195460C
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heart valve
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CN1447670A (zh
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约瑟夫·扬森
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Adiam Life Science AG
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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

Abstract

假体的二尖瓣心脏瓣膜，它由具有基环(15)的支持壳体(10)构成，该基环(15)支持两个基本上指向环轴线方向、经由用于固定两柔性的叶瓣的弧形壁(13、14)连接的侧柱，各侧柱的自由端形成叶瓣的内部支持，其中从俯视图观察，基环具有封闭的非圆形形状，该非圆形形状包括一共同的纵向轴线，但两个不等尺寸的半横轴线。各侧柱位于纵向轴线上并且形成从一半形状至另一半形状的过渡点。为了避免促使紊流的下部凹陷而建议，各侧柱末端(18、19)的连线(17)和侧柱基环形状的共同纵向轴线所在的平面相对于通过共同纵向轴线的、位于垂直于由基环形成的表面(21)的平面倾斜一10°至20°，优选为15°的角度，并且较大曲率的壁支持着具有较小面积的壁形的叶瓣，该叶瓣相对于由基环形成的表面成一倾斜更大的角度设置。

Description

假体的二尖瓣心脏瓣膜
技术领域
本发明涉及一种假体的二尖瓣心脏瓣膜，它由具有基环的支持壳体构成，该基环支持两个基本上指向环轴线方向、经由用于固定两个柔性的叶瓣的弧形壁连接的侧柱，各侧柱的自由端形式叶瓣的内部支持，其中从俯视图观察，基环具有封闭的非圆形形状，该非圆形形状包括一共同的纵向轴线，但两个不等尺寸的半横轴线，各侧柱位于纵向轴线上并且形成从一半形状至另一半形状的过渡点。
背景技术
一种这样的二尖瓣心脏瓣膜由WO 97/49355是已知的。为了避免心脏和心瓣的可能的相互的功能损害，在该公开文本中建议，较小曲率的壁不同于较大曲率的壁支持一以向着基环底面倾斜较大角度设置的面积较小的(壁形的)叶瓣。因此基环的两半形状形成一扩张体，它具有D形或肾形的形状，该形状应该在相当大程度上接近心脏的真(natuerlich)二尖瓣心脏瓣膜。为了减少支持壳体和收缩的心室内壁的干涉和可能的损害的危险，还建议应该使主流方向从正常方向向着壁形的叶瓣倾斜10°至25°，优选为15°。叶瓣应该形成一明显的漏斗形孔道，该孔道具有比主动脉瓣较小的孔横截面。虽然该二尖瓣心脏瓣膜的设置和结构确保从心房向心室的有利的生理流动导向和与至今按现有技术已知的具有圆形的或对称的椭圆形支持壳体横截面的实施形式相比具有较小构造高度的心脏瓣膜，但不能完全避免穿流时的紊流，该紊流出现在扩张内壁对于穿流方向形成下部凹陷(Hinterschneidung)的区域，亦即位于后面凸出的边缘并形成相对于穿流通路的凹室(Nischen)的区域，该凹室促使所不希望的紊流的形成。
发明内容
本发明的目的是，通过结构上的改变改进所述的二尖瓣心脏瓣膜，使其避免这样的促使紊流的下部凹陷。
这个目的通过按照本发明的假体的二尖瓣心脏瓣膜来达到，其特征在于，各侧柱尖端的连线和封闭的基环形状的共同纵向轴线所在的平面相对于通过共同纵向轴线的、位于垂直于由基环形成的表面的平面倾斜10°至20°，优选为15°，以及较大曲率的壁支持着面积较小的壁形的叶瓣，该叶瓣相对于由基环形成的表面成一倾斜更大的角度设置。通过这样的措施构造一支持壳体，其流动方向通过壁相对于基环轴线方向适当地倾斜10°至20°，优选为15°的角度来形成。相对于由WO 97/49355已知的D形或肾形形状，本发明产生转过180°的D形或肾形形状，该形状达到从心房通过心瓣向心室的生理流动。
这样，优选由支持壳体内表面限定的流动方向相对于基环底面倾斜70°至80°，优选为75°。这意味着，朝流动方向稍成圆锥形延伸的支持壳体内壁相对于由各侧柱尖端的连线和流动方向或与其相应的平行平面形成的表面总是倾斜15°。
按照本发明的另一结构，基环底面的两个半横轴线的长度的比值为1.5至2.5∶1。特别是在半轴线比值约为2∶1时可达到在相当大程度上接近真二尖瓣心脏瓣膜的形状。支持壳体的两个不同的半椭圆的共同纵向轴线的长度在10mm与45mm之间。优选各侧柱厚度相同地结合于壁中，即在上述的侧柱的区域内壁内上伸出，特别是向至少基本上尖的端面的侧柱末端伸出，但其尖端优选是倒圆的。为了叶瓣在连合区域不受过强的负荷，按照本发明的另一结构各叶瓣的连线设置成使其与壁的上面的内边缘总是位于一个平面内。
本二尖瓣心脏瓣膜，尤其是相对于作为二尖瓣心脏瓣膜代用品的这样的假体，它按照本发明在病人的凝固障碍药物治疗的全部情况的50％中是需要的，它的特别优点是使用本发明的二尖瓣心脏瓣膜假体的病人可以放弃服药，因为新结构在相当大程度上防止了机械的血液损伤。
在本发明的范围内也包括这样的实施形式，其中由生理真材料制成的叶瓣固定在由塑料制成的支持壳体上。
附图说明
在各附图中示出本发明的一个实施例。附图中：
图1至3    本发明的二尖瓣心脏瓣膜在不同的视角下的各个透视图；
图4和6    由两面(从上和从下)观察的二尖瓣心脏瓣膜的各个俯视图；以及
图5和7    二尖瓣心脏瓣膜的两个侧视图。
具体实施方式
假体的二尖瓣心脏瓣膜由一支持壳体10构成，该支持壳体具有在两个(未示出的)由塑料优选为聚氨酯或由真材料制成的叶瓣，它固定在与各侧柱成一体的壁13、14的端面上。支持壳体10由热塑性塑料，优选由聚氨酯制成，它以轻微弯曲弹性体的方式例如通过注塑制成。该支持壳体为单件并具有基环15，其内边缘向外以按照现有技术已知的方式制成圆形的。为了改进接缝环的固定，该基环具有槽形凹部16。然而相反于WO 97/49355中所述的二尖瓣心脏瓣膜，壁13、14不是统一地垂直于基环底面定位，而是倾斜一约为15°的角度α(特别参见图5)。这样的斜度的特征在于，各侧柱末端18和19的连线17和假体基环形状的共同纵向轴线20所在的平面相对于通过共同纵向轴线的、位于垂直于由基环形成的表面的平面倾斜15°。较大曲率的壁支持着面积较小的壁形的叶瓣，该叶瓣相对于由基环15形成的表面成一倾斜更大的角度设置。相对于由WO 97/49355已知的形状，这里在按照图4的俯视图中产生一镜象反向的D形形状，其中在基环的俯视图中较长的半轴线22位于右边而较短的半轴线23位于左边。通过由线17和20形成的平面相对于垂直方向的几何“倾斜”产生一由支持壳体内表面限定的流动方向24，该方向相对于基环底面倾斜75°。半横轴线22、23的长度的比值在1.5至2.5∶1的范围内。共同的纵向轴线20的长度在10mm与45mm之间。在上述实施例中各侧柱厚度相同地结合于壁13和14中，其中端面的侧柱末端18、19至少基本上成尖端伸出。各叶瓣的连线与壁13、14的上面的内边缘11、12总是位于一个平面内。如由图5显而易见的，倾斜较小的主动脉叶瓣倾斜约γ＝40°，而倾斜较大的壁形的叶瓣倾斜约β＝55°。
表示与流动方向相反的俯视图的图6示出内边缘11和12的投影图同样具有肾形或D形的轮廓形状，但相对于由基环面构成的轮廓形状再度镜象对称地构成，亦即在此较短的半轴线设在右边，以及在流动外侧的区域内叶瓣支持面的结构仍保持为由WO 97/49355描述和图示的形状。

Claims (8)

1.假体的二尖瓣心脏瓣膜，它由具有基环(15)的支持壳体(10)构成，该基环(15)支持两个基本上指向环轴线方向、经由用于固定两个柔性的叶瓣的弧形壁(13、14)连接的侧柱，各侧柱的自由端形成叶瓣的内部支持，其中从俯视图观察，基环具有封闭的非圆形形状，该形状包括一共同的纵向轴线、但两个不等尺寸的半横轴线，各侧柱位于纵向轴线上并且形成从一半形状至另一半形状的过渡点；其特征在于，各侧柱末端(18、19)的连线(17)和侧柱基环形状的共同纵向轴线所在的平面相对于通过共同纵向轴线的、位于垂直于由基环形成的表面(21)的平面倾斜一10°至20°的角度(α)，并且较大曲率的壁支持着面积较小的壁形的叶瓣，该叶瓣相对于由基环形成的表面成一倾斜更大的角度设置。
2.按照权利要求1所述的二尖瓣心脏瓣膜，其特征在于，由支持壳体内表面限定的流动方向(24)相对于基环底面倾斜一70°至80°的角度。
3.按照权利要求1或2所述的二尖瓣心脏瓣膜，其特征在于，由各叶瓣的连线与壁的上面的内边缘的位置确定的叶瓣斜角分别相对于基环底面对于倾斜较小的、即主动脉的叶瓣在25°与45°之间而对于倾斜较大的、即壁形的叶瓣在55°与70°之间，同时倾斜较大的叶瓣比倾斜较小的叶瓣大至少10°地倾斜。
4.按照权利要求1所述的二尖瓣心脏瓣膜，其特征在于，半横轴线(22、23)的长度的比值为1.5至2.5∶1。
5.按照权利要求1所述的二尖瓣心脏瓣膜，其特征在于，共同的纵向轴线(20)的长度(1)在10mm与45mm之间。
6.按照权利要求1所述的二尖瓣心脏瓣膜，其特征在于，各侧柱厚度相同地结合于壁中。
7.按照权利要求6所述的二尖瓣心脏瓣膜，其特征在于，端面的侧柱末端(18、19)至少基本上成尖端伸出。
8.按照权利要求1所述的二尖瓣心脏瓣膜，其特征在于，各叶瓣的连线与壁(13、14)的上面的内边缘(11、12)总是位于一个平面内。
CNB018143555A 2000-09-19 2001-08-25 假体的二尖瓣心脏瓣膜 Expired - Fee Related CN1195460C (zh)

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WO2002024117A1 (de) 2002-03-28
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ATE296070T1 (de) 2005-06-15
BR0113966A (pt) 2003-07-29
CN1447670A (zh) 2003-10-08
US6780200B2 (en) 2004-08-24
MXPA03002317A (es) 2005-09-15
ES2243545T3 (es) 2005-12-01
US20040102842A1 (en) 2004-05-27
DE10046550A1 (de) 2002-03-28
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EP1318774B1 (de) 2005-05-25
EP1318774A1 (de) 2003-06-18

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