CN113274169B - Radially-enhanced textile-based artificial heart valve - Google Patents

Abstract

Translated fromChinese

本发明涉及一种径向增强的纺织基人工心脏瓣膜，包括纺织基瓣叶，所述纺织基瓣叶的径向纱线中包括增强纱线和高分子纱线；所述径向纱线指纺织基瓣叶径向上的纱线；所述增强纱线为金属丝或者所述金属丝与高分子纤维构成的复合纱线；本发明以高分子纱线和金属丝为原料，在保证瓣叶轻薄、具有一定柔韧性的前提下提高瓣叶的运动稳定性、力学支撑性、弯曲回弹性以及耐疲劳性，相较于未增强的瓣膜而言，具备更为优异的机械性能、血流动力学性能和耐久性。

The invention relates to a radially reinforced textile-based artificial heart valve, comprising a textile-based valve leaflet, and radial yarns of the textile-based valve leaflet include reinforcing yarns and polymer yarns; the radial yarns refer to Textile yarns in the radial direction of the base leaflet; the reinforcing yarns are metal wires or composite yarns composed of the metal wires and polymer fibers; the present invention uses polymer yarns and metal wires as raw materials to ensure the valve leaflet. On the premise of being thin and flexible, it improves the motion stability, mechanical support, bending resilience and fatigue resistance of the valve leaflet. Compared with the unreinforced valve, it has better mechanical properties, hemodynamics performance and durability.

Description

Translated fromChinese

一种径向增强的纺织基人工心脏瓣膜A radially reinforced textile-based artificial heart valve

技术领域technical field

本发明属医疗器械技术领域，涉及一种径向增强的纺织基人工心脏瓣膜。The invention belongs to the technical field of medical devices, and relates to a radially reinforced textile-based artificial heart valve.

背景技术Background technique

在我国，瓣膜性心脏病的发病率为2.5～3.2％，患者约有400万人，每年需要进行瓣膜手术的患者达20多万例，目前占成人心脏手术的第一位。当心脏瓣膜病变到一定程度时，无法通过手术修复，主要通过人工心脏瓣膜置换进行治疗，以此恢复或改善瓣膜功能。目前，临床上广泛使用的人工心脏瓣膜包括机械瓣和生物瓣，但是机械瓣易产生血栓，患者需终身服用抗凝药物；生物瓣易发生钙化衰败，耐久性较差。经过十多年临床实践的经导管主动脉瓣置换术(Transcatheter aortic valve replacement,TAVR)由于具备风险小、创伤小、手术快、患者术后恢复快等特点，为难以进行开胸手术的高龄、高危患者提供了更加合适的选择，未来还可能惠及低龄、轻症患者。目前，临床上使用的经导管人工心脏瓣膜主要由自膨胀式/球囊扩张式金属支架及类似于外科瓣的生物组织(牛心包、猪心包、猪主动脉瓣等)构成，因此其不仅存在生物组织本身易钙化的缺陷，且在装载过程生易受到压缩折叠损伤，使用前便已发生降解，导致材料耐久性进一步降低。另外，为满足经导管植入的要求，一般要求瓣叶材料厚度小，以增加其可折叠性。In my country, the incidence of valvular heart disease is 2.5% to 3.2%, and there are about 4 million patients. More than 200,000 patients need valve surgery every year, which currently ranks first in adult heart surgery. When the heart valve disease reaches a certain level and cannot be repaired by surgery, it is mainly treated by artificial heart valve replacement to restore or improve the valve function. At present, the artificial heart valves widely used in clinic include mechanical valve and biological valve, but mechanical valve is prone to thrombus, and patients need to take anticoagulant drugs for life; biological valve is prone to calcification and decay, and its durability is poor. After more than ten years of clinical practice, transcatheter aortic valve replacement (TAVR) has the characteristics of low risk, small trauma, quick operation, and quick postoperative recovery of patients. High-risk patients provide more suitable options, and it may also benefit younger and milder patients in the future. At present, the clinically used transcatheter artificial heart valves are mainly composed of self-expanding/balloon-expandable metal stents and biological tissues similar to surgical valves (bovine pericardium, porcine pericardium, porcine aortic valve, etc.), so they not only exist The biological tissue itself is prone to calcification, and is easily damaged by compression and folding during the loading process, and degrades before use, resulting in a further reduction in the durability of the material. In addition, in order to meet the requirements of transcatheter implantation, the thickness of the leaflet material is generally required to be small to increase its foldability.

目前的研究热点包括利用各种高分子材料来克服生物瓣和机械瓣的缺陷并有利于TAVR手术的新一代人工心脏瓣膜。常见的瓣叶基材形式包括高分子薄膜及微纳尺度的纤维基材料，加工方式包括塑料成型技术、静电纺丝技术、3D打印技术和纺织技术等。从心脏瓣膜启闭机理出发，合适的人工心脏瓣膜在对任意一侧做出压差响应时，需要很容易地打开和关闭，也就是说，瓣膜打开时，血液所受流动阻力极小，能够顺利流出，且在较小的压差下就能立即关闭，关闭返流量很小。由于开启时间非常短，血流处于高速状态，因此薄而柔韧的瓣叶更有利于瓣口面积的增大以及血液的顺利流出。有研究表明，厚度极小、柔韧性极好的瓣叶虽然运动灵活，但往往不会以受控的方式打开和关闭。舒张期瓣叶易因支撑力不足而产生塌陷、脱垂，造成血液大量返流等不良现象，从而丧失瓣膜的功能性；开闭过程中瓣叶可能由底部向自由边传递产生行波，产生不良的拍打运动(或称抖动)；循环加载过程易使得机械性能不足的瓣叶产生严重的应力集中现象并最终导致孔洞和裂纹的形成，或是诱导钙化，从而影响瓣膜的功能性和耐久性。另一方面，厚度大的瓣叶虽然机械强度高、力学支撑性好，但开合运动不灵敏，且瓣口面积小，血液流出不畅。因此，合理控制瓣叶材料的厚度、结构和机械性能对瓣膜的血流动力学性能和耐久性的提升至关重要。Current research hotspots include a new generation of artificial heart valves that utilize various polymer materials to overcome the defects of biological and mechanical valves and facilitate TAVR surgery. Common forms of leaflet substrates include polymer films and micro- and nano-scale fiber-based materials, and processing methods include plastic molding technology, electrospinning technology, 3D printing technology, and textile technology. Starting from the opening and closing mechanism of the heart valve, a suitable artificial heart valve needs to be easily opened and closed when it responds to the pressure difference on either side. It flows out smoothly, and it can be closed immediately under a small pressure difference, and the closed backflow is very small. Since the opening time is very short and the blood flow is at a high speed, the thin and flexible valve leaflets are more conducive to the increase of the valve area and the smooth outflow of blood. Studies have shown that leaflets that are extremely thin and extremely flexible, although flexible, often do not open and close in a controlled manner. During the diastole, the valve leaflets are prone to collapse and prolapse due to insufficient support, resulting in a large amount of blood backflow and other undesirable phenomena, thereby losing the function of the valve; Poor flapping motion (or jitter); the cyclic loading process tends to cause severe stress concentrations in the mechanically deficient leaflets and eventually lead to the formation of holes and cracks, or induce calcification, thereby affecting the function and durability of the valve . On the other hand, although the valve leaflet with large thickness has high mechanical strength and good mechanical support, the opening and closing movement is not sensitive, and the valve opening area is small, and the blood outflow is not smooth. Therefore, rational control of the thickness, structure and mechanical properties of the valve leaflet material is crucial for the improvement of the hemodynamic performance and durability of the valve.

利用纺织技术加工得到的纺织基人工心脏瓣膜具备众多优势，其能够精确地控制支架材料的组成、厚度和结构等来优化介入过程并实现产品最终几何形状和生物力学性能的调节，并在外科瓣、经导管瓣膜、带瓣管道、组织工程瓣膜等领域有着广泛的应用前景。相较于机械瓣而言，其具备良好的柔韧性和生物相容性；相较于生物瓣而言，其不易因钙化导致衰败，且原料更易获取，有利于减少批次间的差异和实现批量化生产；相较于以生物组织为瓣叶材料的经导管瓣膜而言，其在具有较小厚度、易于压缩进入鞘管的前提下，具备更为优异的耐折叠压缩性，可在更大程度地保留原有机械性能；相较于其他材料的组织工程瓣膜而言，其能合理调控孔隙率和孔径，便于细胞的种植和生长，且机械强度高，可保证移植后的生理稳定性，此外，在构建全降解和部分降解材料方面亦具备独特的优势。The textile-based artificial heart valve processed by textile technology has many advantages. It can precisely control the composition, thickness and structure of the stent material to optimize the intervention process and realize the adjustment of the final geometry and biomechanical properties of the product. , transcatheter valve, valved pipeline, tissue engineering valve and other fields have broad application prospects. Compared with mechanical valves, it has good flexibility and biocompatibility; compared with biological valves, it is not prone to decay due to calcification, and the raw materials are easier to obtain, which is conducive to reducing batch-to-batch variation and realization Mass production; compared with the transcatheter valve using biological tissue as the leaflet material, it has better resistance to folding and compression under the premise of having a smaller thickness and being easy to compress into the sheath. Retain the original mechanical properties to a large extent; compared with other tissue engineering valves, it can reasonably control the porosity and pore size, which is convenient for cell planting and growth, and has high mechanical strength, which can ensure the physiological stability after transplantation In addition, it also has unique advantages in constructing fully degradable and partially degradable materials.

现有研究中的纺织基人工心脏瓣膜的瓣叶材料一般是由柔性聚合物纱线构成的纯织物或织物增强聚合物基复合材料。不过粘弹性材料具有滞后效应，很难对压差变化做出快速响应，且聚合物材料的耐疲劳性普遍存在一定的局限性。有文献公开了以超弹性形状记忆镍钛合金丝为原料、采用机织技术成型并结合组织工程技术制备的人工心脏瓣膜。脉动流测试结果表明，其有效开口面积是对照组的商用生物瓣(牛心包)的1.70～1.79倍，具有优异的弹性和顺应性。尽管镍钛合金丝的顺应性好、回复形变能力强、耐疲劳性好，但纯金属瓣叶相对纯柔性聚合物材料而言整体质量和刚度大，不利于瓣叶在开合循环中保持运动的灵活性和在舒张期闭合时呈现出良好的接合形态，也不适合经导管植入，因而限制了其应用范围；此外，镍钛合金丝与聚合物的界面结合强度也有待提高。The leaflet materials of textile-based artificial heart valves in existing research are generally pure fabrics or fabric-reinforced polymer-based composite materials composed of flexible polymer yarns. However, viscoelastic materials have a hysteresis effect, which makes it difficult to respond quickly to changes in pressure difference, and the fatigue resistance of polymer materials generally has certain limitations. A document discloses an artificial heart valve prepared from superelastic shape memory nickel-titanium alloy wire, formed by weaving technology and combined with tissue engineering technology. The pulsatile flow test results show that its effective opening area is 1.70-1.79 times that of the commercial biological valve (bovine pericardium) of the control group, and it has excellent elasticity and compliance. Although nickel-titanium alloy wire has good compliance, strong recovery deformation ability, and good fatigue resistance, the overall mass and stiffness of pure metal valve leaflets are higher than that of pure flexible polymer materials, which is not conducive to the valve leaflets maintaining movement during opening and closing cycles. It is not suitable for transcatheter implantation, which limits its application scope; in addition, the interfacial bonding strength of nitinol wire and polymer also needs to be improved.

综上所述，亟待开发出一种结合聚合物纱线和形状记忆合金丝优势的纺织基人工心脏瓣膜。In conclusion, there is an urgent need to develop a textile-based artificial heart valve that combines the advantages of polymer yarns and shape memory alloy wires.

发明内容SUMMARY OF THE INVENTION

本发明所要解决的技术问题是提供一种径向增强的纺织基人工心脏瓣膜，利用机织技术制备纺织基瓣叶中的织物，瓣叶的径向与周向上均含有柔性高分子纱线，提供良好的柔韧性，有利于瓣膜经导管植入且在心动周期内保持灵活开闭；在瓣叶的径向上选择性(指各种中心对称分布方式以及贯穿区间)地织入金属丝，提供优异的机械强度、弯曲回弹性以及耐疲劳性，从而改善瓣膜的血流动力学性能和耐久性，因而具有重要的临床应用价值。与未增强的纺织基人工心脏瓣膜相比，径向增强的纺织基人工心脏瓣膜的血流动力学性有显著提升，有效开口面积、返流分数和平均跨瓣压差等重要技术指标均满足GB 12279-2008国家标准和ISO 5840国际标准，且均有不同程度的改善；有限元分析结果表明，金属丝的织入使得高分子材料部分的等效应力和等效应变数值均有下降，有效缓解了高分子材料上的应力集中现象，对瓣膜耐久性的提高具有重要意义。The technical problem to be solved by the present invention is to provide a radially reinforced textile-based artificial heart valve. The fabric in the textile-based valve leaflets is prepared by weaving technology, and the radial and circumferential directions of the valve leaflets contain flexible polymer yarns. Provides good flexibility, which is beneficial to the transcatheter implantation of the valve and maintains flexible opening and closing during the cardiac cycle; selectively woven into the metal wire in the radial direction of the valve leaflet (referring to various center-symmetric distribution patterns and throughout the interval), providing Excellent mechanical strength, flexural resilience and fatigue resistance can improve the hemodynamic performance and durability of the valve, and thus have important clinical application value. Compared with the unreinforced textile-based artificial heart valve, the hemodynamics of the radially reinforced textile-based artificial heart valve are significantly improved, and the important technical indicators such as effective opening area, regurgitation fraction and average transvalvular pressure difference all meet the requirements. GB 12279-2008 national standard and ISO 5840 international standard, and both have different degrees of improvement; the finite element analysis results show that the equivalent stress and equivalent strain values of the polymer material are reduced by the weaving of the metal wire, which is effective The stress concentration phenomenon on the polymer material is alleviated, which is of great significance to the improvement of the valve durability.

为实现上述目的，本发明的技术方案如下：For achieving the above object, technical scheme of the present invention is as follows:

一种径向增强的纺织基人工心脏瓣膜，包括纺织基瓣叶，所述纺织基瓣叶的径向纱线中包括增强纱线和高分子纱线。A radially reinforced textile-based artificial heart valve comprises a textile-based valve leaflet, and radial yarns of the textile-based valve leaflet include reinforcing yarns and polymer yarns.

所述径向纱线指纺织基瓣叶径向上的纱线；The radial yarns refer to yarns in the radial direction of the textile base leaflet;

所述增强纱线为金属丝或者所述金属丝与高分子纤维构成的复合纱线。The reinforcing yarns are metal wires or composite yarns composed of the metal wires and polymer fibers.

作为优选的技术方案：As the preferred technical solution:

如上所述的一种径向增强的纺织基人工心脏瓣膜，所述径向纱线由所述增强纱线和高分子纱线组成；所述增强纱线的根数占比为所述径向纱线总根数的1～50％(优选10～30％)；所述增强纱线的根数太少，对瓣膜血流动力学性能和耐久性的增强无明显作用；根数太多，会导致瓣叶的质量过大且柔韧性变差，不利于其灵活开闭、快速响应压差的变化。A radially reinforced textile-based artificial heart valve as described above, wherein the radial yarns are composed of the reinforcing yarns and the polymer yarns; the number of the reinforcing yarns accounts for the radial direction 1 to 50% of the total number of yarns (preferably 10 to 30%); the number of the reinforcing yarns is too small, and it has no obvious effect on the enhancement of the hemodynamic performance and durability of the valve; This will lead to excessive mass of the valve leaflet and poor flexibility, which is not conducive to its flexible opening and closing and rapid response to changes in pressure difference.

如上所述的一种径向增强的纺织基人工心脏瓣膜，所述径向增强的纺织基人工心脏瓣膜包括两个或三个所述纺织基瓣叶，在同一纺织基瓣叶中，所述增强纱线呈中心对称分布。A radially reinforced textile-based artificial heart valve as described above, the radially reinforced textile-based artificial heart valve comprises two or three of the textile-based valve leaflets, and in the same textile-based valve leaflet, the The reinforcing yarns are distributed centrally symmetrically.

其排布方式为下列之一：Its arrangement is one of the following:

第一种排布方式为均匀分布，即所述增强纱线均匀地分布在所述径向纱线中；The first arrangement is uniform distribution, that is, the reinforcing yarns are evenly distributed in the radial yarns;

第二种排布方式为单元均匀分布，即单元均匀地分布在所述径向纱线中；所述单元由多根相邻的所述增强纱线组成，或者由多根邻近的所述增强纱线及其间间隔的少数所述高分子纱线组成；所述多根指所述增强纱线根数占所属单元内纱线总根数的50％以上；所述单元内纱线总根数为径向纱线总根数的3～20％；所述少数指所述高分子纱线的根数不超过所属单元内所述增强纱线根数总和的50％；The second arrangement is the uniform distribution of units, that is, the units are uniformly distributed in the radial yarns; the unit is composed of a plurality of adjacent reinforcing yarns, or a plurality of adjacent reinforcing yarns Yarn and a small number of the polymer yarns spaced between them; the plurality of yarns means that the number of reinforcing yarns accounts for more than 50% of the total number of yarns in the unit; the total number of yarns in the unit It is 3-20% of the total number of radial yarns; the minority means that the number of the polymer yarns does not exceed 50% of the total number of the reinforcing yarns in the unit to which it belongs;

第三种排布方式为单元对称分布，即单元由中间向两侧按一定规律变化；所述按一定规律变化是指：所述单元的宽度、所述单元间的间距或所述单元内的所述增强纱线的根数、所述单元内所述增强纱线的直径大小呈单调递增或单调递减，或者所述单元内所述增强纱线的种类发生改变；所述增强纱线的种类包括其包含的金属丝或高分子纤维的种类。The third arrangement is the symmetrical distribution of units, that is, the units change according to a certain rule from the middle to the two sides. The number of the reinforcing yarns and the diameter of the reinforcing yarns in the unit are monotonically increasing or decreasing, or the types of the reinforcing yarns in the unit are changed; the types of the reinforcing yarns Including the type of metal wire or polymer fiber it contains.

例如：(1)各个单元的宽度相同，单元间的间隔不变，但是增强纱线的根数(或粗细或种类)在变化；(2)各个单元相同，但是单元间的间距改变；(3)单元间的间距相同，增强纱线的粗细或种类相同，但是增强纱线的根数或单元的宽度改变。For example: (1) the width of each unit is the same, the spacing between the units is unchanged, but the number (or thickness or type) of reinforcing yarns is changing; (2) the units are the same, but the spacing between the units changes; (3) ) The spacing between the units is the same, the thickness or type of the reinforcing yarn is the same, but the number of reinforcing yarns or the width of the unit is changed.

如上所述的一种径向增强的纺织基人工心脏瓣膜，所述纺织基瓣叶由所述径向纱线与周向纱线交织而成的；所述周向纱线是指纺织基瓣叶周向上的纱线，所述周向纱线为高分子纱线。A radially reinforced textile-based artificial heart valve as described above, wherein the textile-based valve leaflets are interwoven with the radial yarns and the circumferential yarns; the circumferential yarns refer to the textile-based valve Yarns in the circumferential direction of the leaf, the circumferential yarns are polymer yarns.

所述高分子纱线为单丝、复丝、包芯纱、包覆纱、编织纱、纳米静电纺纱线或者长丝/纳米纤维包覆纱；The polymer yarn is monofilament, multifilament, core-spun yarn, covered yarn, braided yarn, nano-electrospinning yarn or filament/nanofiber covered yarn;

所述高分子纱线的原料为不可降解材料和可降解材料中的一种或两者的组合；The raw material of the polymer yarn is one or a combination of non-degradable materials and degradable materials;

不可降解材料为聚对苯二甲酸乙二醇酯(PET)、聚对苯二甲酸丁二醇酯(PBT)、聚对苯二甲酸丙二醇酯(PTT)、聚四氟乙烯(PTFE)、聚酰胺(PA)、聚丙烯(PP)、聚乙烯(PE)、聚氨酯(PU)、超高分子量聚乙烯(UHMWPE)、真丝中的一种或几种；Non-degradable materials are polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polytrimethylene terephthalate (PTT), polytetrafluoroethylene (PTFE), poly One or more of amide (PA), polypropylene (PP), polyethylene (PE), polyurethane (PU), ultra-high molecular weight polyethylene (UHMWPE) and silk;

可降解材料为聚己内酯(PCL)、聚乳酸(PLA)、左旋聚乳酸(PLLA)、聚乙交酯(PGA)、聚乳酸-羟基乙酸共聚物(PLGA)、聚对二氧环己酮(PPDO)、聚癸二酸丙三醇酯(PGS)、聚乙丙交酯(PGLA)、丝素蛋白、胶原蛋白、透明质酸、明胶中的一种或几种。The degradable materials are polycaprolactone (PCL), polylactic acid (PLA), L-polylactic acid (PLLA), polyglycolide (PGA), polylactic acid-co-glycolic acid (PLGA), poly-p-dioxane One or more of ketone (PPDO), polyglycerol sebacate (PGS), polyglycolide (PGLA), silk fibroin, collagen, hyaluronic acid, and gelatin.

所述纺织基瓣叶中的织物可以是不可降解的或可部分降解的；The fabric in the textile-based leaflet may be non-degradable or partially degradable;

所述不可降解的织物包含增强纱线和不可降解的高分子纱线；The non-degradable fabric comprises reinforcing yarns and non-degradable polymer yarns;

所述可部分降解的织物必须包含增强纱线和可降解的高分子纱线，不必要包含不可降解的高分子纱线。The partially degradable fabric must contain reinforcing yarns and degradable polymer yarns, not necessarily non-degradable polymer yarns.

可部分降解的瓣膜中，可降解部分被新生组织取代，不可降解部分将作为永久性的力学支撑，可靠性更高。In the partially degradable valve, the degradable part is replaced by new tissue, and the non-degradable part will serve as a permanent mechanical support, with higher reliability.

如上所述的一种径向增强的纺织基人工心脏瓣膜，所述金属丝为形状记忆合金丝。形状记忆合金丝包含铜基形状记忆合金丝和镍钛基形状记忆合金丝(优选镍钛基形状记忆合金丝，后续简称为镍钛合金丝)；所述形状记忆合金丝具有超弹性(或称伪弹性)，试样在外力作用下能产生远大于其弹性极限应变量的应变，在卸载时应变可自动恢复；所述镍钛合金丝的伸缩率在20％以上，疲劳寿命达1×10⁷，阻尼特性比普通的弹簧高10倍，其耐腐蚀性优于目前最好的医用不锈钢。In the radially reinforced textile-based artificial heart valve as described above, the metal wire is a shape memory alloy wire. The shape memory alloy wire includes a copper-based shape memory alloy wire and a nickel-titanium-based shape memory alloy wire (preferably a nickel-titanium-based shape memory alloy wire, hereinafter referred to as a nickel-titanium alloy wire); the shape memory alloy wire has superelasticity (or Pseudo-elasticity), the sample can generate a strain far greater than its elastic limit strain under the action of external force, and the strain can automatically recover when unloaded; the expansion ratio of the nickel-titanium alloy wire is more than 20%, and the fatigue life reaches 1 × 10^7. The damping characteristic is 10 times higher than that of ordinary springs, and its corrosion resistance is better than that of the best medical stainless steel at present.

如上所述的一种径向增强的纺织基人工心脏瓣膜，所述纺织基瓣叶分为底部、腹部、接合区和自由边四个区域；所述增强纱线至少贯穿于腹部。A radially reinforced textile-based artificial heart valve as described above, the textile-based valve leaflet is divided into four regions: the bottom, the abdomen, the coaptation area and the free edge; the reinforcing yarn at least runs through the abdomen.

如上所述的一种径向增强的纺织基人工心脏瓣膜，所述增强纱线至少连续贯穿于底部和腹部。In the radially reinforced textile-based artificial heart valve as described above, the reinforcing yarn at least continuously penetrates the bottom and the abdomen.

在织造轻薄(0.05～0.3mm)织物的前提下，本发明中的增强纱线有四个作用：On the premise of weaving light and thin (0.05-0.3mm) fabrics, the reinforcing yarn in the present invention has four functions:

(1)保证瓣叶在开闭过程中具备优异的运动稳定性，保持良好的运动形态，无拍打/抖动现象；(1) Ensure that the valve leaflets have excellent movement stability during the opening and closing process, maintain a good movement shape, and have no flapping/jitter phenomenon;

(2)增加瓣叶的力学支撑性，使其具备良好的力学性能并能在舒张期保持紧密的接合状态，避免在较高的主动脉压力下破裂、脱垂；(2) Increase the mechanical support of the valve leaflets, so that they have good mechanical properties and can maintain a tight joint state during diastole to avoid rupture and prolapse under high aortic pressure;

(3)辅助承受瓣叶循环开闭过程中的拉伸、弯曲和剪切作用下的复合载荷，提高瓣叶的耐久性；(3) Auxiliary to bear the composite load under the action of stretching, bending and shearing during the cyclic opening and closing of the valve leaflet to improve the durability of the valve leaflet;

(4)在保证瓣叶弯曲刚度较小、在反向血流压力作用下易关闭的前提下，增加瓣叶的弯曲回弹性，使得瓣叶在收缩期具有主动由关闭状态回复至打开状态的趋势，能够快速响应压差的变化，迅速打开且瓣口面积大，从而使得血流快速、顺利地流出。(4) On the premise of ensuring that the valve leaflet has a small bending stiffness and is easy to close under the action of reverse blood flow pressure, the bending resilience of the valve leaflet is increased, so that the valve leaflet has the ability to actively return from the closed state to the open state during systole. It can quickly respond to changes in pressure difference, open quickly and have a large valve area, so that blood can flow out quickly and smoothly.

在实现上述作用时，增强纱线可以仅存在于瓣叶中，也可存在于瓣叶以及与瓣叶共同织造出的被用作附件的织物中。所述附件与瓣叶是以瓣叶底部作为分界线的。当所述增强纱线仅存在于瓣叶中，那么具备上述作用(1)～(3)；增强纱线连续存在于瓣叶及其附件中，那么具备上述作用(1)～(4)。当增强纱线连续贯穿于附件及瓣叶中的底部和腹部时，这样可以起到上述作用(1)～(4)。当增强纱线贯穿于瓣叶的腹部却未贯穿底部时，这样可以起到上述作用(1)～(3)。In achieving the above effects, the reinforcing yarns may exist only in the leaflets, or in the leaflets and the fabric co-woven with the leaflets that are used as accessories. The appendix and the leaflet are separated by the bottom of the leaflet. When the reinforcing yarn only exists in the valve leaflet, it has the above-mentioned functions (1) to (3); if the reinforcing yarn exists continuously in the valve leaflet and its accessories, it has the above-mentioned functions (1) to (4). When the reinforcing yarn continuously penetrates the base and abdomen of the appendages and the leaflets, the above-mentioned functions (1) to (4) can be achieved. When the reinforcing yarn penetrates through the abdomen of the leaflet but not through the bottom, the above-mentioned functions (1) to (3) can be achieved.

如上所述的一种径向增强的纺织基人工心脏瓣膜，所述纺织基瓣叶在平面状态下，径向纱线与瓣叶径向中心对称轴的夹角为0°、30°或45°。A radially reinforced textile-based artificial heart valve as described above, in the plane state of the textile-based valve leaflet, the included angle between the radial yarn and the radial center symmetry axis of the valve leaflet is 0°, 30° or 45° °.

组织结构与夹角的选配存在一定的关系。There is a certain relationship between organizational structure and the selection of included angles.

(1)0°夹角对应于常规平面或管状机织物，金属丝的方向与瓣叶径向中心线平行；在瓣膜成型时中存在3°以内的误差；(1) The included angle of 0° corresponds to a conventional plane or tubular woven fabric, and the direction of the metal wire is parallel to the radial centerline of the valve leaflet; there is an error within 3° during valve molding;

(2)45°夹角对应于常规平面机织物，金属丝的方向与瓣叶径向中心线成45°夹角；在瓣膜成型时存在3°以内的误差；(2) The included angle of 45° corresponds to the conventional plane woven fabric, and the direction of the metal wire forms an included angle of 45° with the radial centerline of the valve leaflet; there is an error within 3° during valve molding;

(3)30°夹角对应于平面三向织物，金属丝的方向与瓣叶径向中心线成30°夹角，在瓣膜成型时存在3°以内的误差。(3) The included angle of 30° corresponds to the plane three-way fabric, and the direction of the metal wire forms an included angle of 30° with the radial centerline of the valve leaflet, and there is an error within 3° during valve molding.

当金属丝与径向中心线的夹角在0～45°范围内时，对瓣叶的弯曲回弹性的提高和维持开合运动的稳定性(避免抖动/拍打现象)均有较为显著的效果。When the angle between the metal wire and the radial centerline is in the range of 0 to 45°, it has a significant effect on improving the bending resilience of the valve leaflet and maintaining the stability of the opening and closing movement (avoiding jitter/beating). .

如上所述的一种径向增强的纺织基人工心脏瓣膜，所述纺织基瓣叶由二向织物或平面三向织物构成；二向织物的组织结构包括平纹组织、斜纹组织、缎纹组织、平纹变化组织、斜纹变化组织、缎纹变化组织、重组织、双层组织及多层组织中的一种或几种；平面三向织物的组织结构包括平纹三向组织、斜纹三向组织和双平纹三向组织的一种或几种。A radially reinforced textile-based artificial heart valve as described above, the textile-based valve leaflet is composed of two-way fabric or plane three-way fabric; the tissue structure of the two-way fabric includes plain weave, twill weave, satin weave, One or more of plain weave, twill weave, satin weave, heavy weave, double-layer weave and multi-layer weave; the weave structure of flat three-way fabric includes plain weave three-way weave, twill three-way weave and double weave One or several types of plain weave three-way weave.

如上所述的一种径向增强的纺织基人工心脏瓣膜，织造所述纺织基瓣叶时，上机经密为150～2000根/10cm，上机纬密为150～2000根/10cm。当织物紧度高时，织物的水渗透率低，可以不需要进行涂层处理，一般用作永久置换的瓣膜；当织物紧度不高时，织物的水渗透率较高，需要进行涂层处理，以减少渗漏量，既可用作永久置换的瓣膜，也可用作具备再生能力的组织工程瓣膜。For the above-mentioned radially reinforced textile-based artificial heart valve, when weaving the textile-based valve leaflets, the upper machine warp density is 150-2000 pieces/10cm, and the upper machine weft density is 150-2000 pieces/10cm. When the fabric tightness is high, the water permeability of the fabric is low, and coating treatment is not required, and it is generally used as a valve for permanent replacement; when the fabric tightness is not high, the water permeability of the fabric is high, and coating is required. Treated to reduce leakage, both as a valve for permanent replacement and as a tissue-engineered valve with regenerative capabilities.

如上所述的一种径向增强的纺织基人工心脏瓣膜，所述纺织基瓣叶的厚度为0.05～0.3mm，所述增强纱线和所述高分子纱线的直径均小于0.2mm。本发明的纺织基瓣叶与无径向增强的纺织基瓣叶相比，具备相近的厚度和略大的弯曲刚度，但机械强度和模量、弯曲回弹性、耐疲劳性均有显著性的提高，对后续制得的人工心脏瓣膜的血流动力学性能和耐久性的改善均有积极的影响。In the above radially reinforced textile-based artificial heart valve, the thickness of the textile-based valve leaflet is 0.05-0.3 mm, and the diameters of the reinforcing yarn and the polymer yarn are both less than 0.2 mm. Compared with the textile base leaflet without radial reinforcement, the textile base leaflet of the present invention has similar thickness and slightly larger bending stiffness, but the mechanical strength and modulus, bending resilience and fatigue resistance are all significantly improved. The improvement has a positive impact on the improvement of the hemodynamic performance and durability of the artificial heart valve produced subsequently.

所述复合纱线按纱线类型可分为编织纱、合股纱和包覆纱；所述复合纱线中的高分子纤维按几何长度可分为长丝和短纤维；所述复合纱线的优势在于能够显著增加其内金属丝与相邻或相交高分子纱线间的摩擦力，从而保证其具有一定的可织性且提高结构稳定性。The composite yarn can be divided into braided yarn, plied yarn and covered yarn according to the yarn type; the polymer fibers in the composite yarn can be divided into filament and short fiber according to the geometric length; The advantage is that the friction force between the inner metal wire and the adjacent or intersecting polymer yarn can be significantly increased, so as to ensure a certain weavability and improve the structural stability.

所述纺织基瓣叶的自由边的长度比瓣膜直径大5％以上，具有关闭瓣膜所需的最小长度；所述自由边的形状为曲线(包括直线或弧形)，其中，弧形相较于直线而言，能够以最小的接合面积在中心处提供足够材料来密封反向流体，以使血液中的红细胞在接触面之间的损坏最小，又使得瓣尖不致粘住而阻碍瓣叶的开启；所述自由边具有稳定化结构，且光滑、平整；所述作为自由边的织物，有五种形成方式：The length of the free side of the textile-based valve leaflet is more than 5% larger than the valve diameter, and has the minimum length required to close the valve; the shape of the free side is a curve (including a straight line or an arc), wherein the arc is relatively In a straight line, sufficient material can be provided at the center with a minimal coaptation area to seal the reverse fluid to minimize damage to red blood cells in the blood between the contact surfaces, yet keep the valve cusps from sticking and obstructing the leaflets. Open; the free edge has a stabilized structure, and is smooth and flat; the fabric as the free edge has five forming methods:

(1)采用织造过程中的织边。(1) Adopt selvedge in the weaving process.

①若瓣叶径向对应于织物纬向，瓣叶周向对应于织物经向，那么自由边为常规的经向织边。一方面避免了切割可能导致的脱散现象，有利于保持织物结构的稳定性且简化了操作，一方面布边本身的特性使得自由边在瓣叶反复加载过程中可承受较小的弯曲变形，具有良好的耐疲劳性能。所述经向布边在织造过程中的意义在于承受各种外力的作用，保护织物的边缘不受损伤；所述布边的特性是：强度高、平直光洁，厚度与布身一致或接近，紧度与布身一致或稍紧；①If the radial direction of the leaflet corresponds to the weft direction of the fabric, and the circumferential direction of the leaflet corresponds to the warp direction of the fabric, then the free edge is a conventional warp selvedge. On the one hand, it avoids the detachment phenomenon that may be caused by cutting, which is conducive to maintaining the stability of the fabric structure and simplifies the operation. Has good fatigue resistance. The significance of the warp selvedge in the weaving process is to withstand the action of various external forces and protect the edge of the fabric from damage; the characteristics of the selvage are: high strength, straight and smooth, and the thickness is consistent with or close to the cloth body , the tightness is the same as the cloth body or slightly tighter;

②若瓣叶径向对应于织物经向，瓣叶周向对应于织物纬向，那么自由边为特殊的纬向织边。避免了切割可能导致的脱散现象(现有技术中已有记载)，有利于保持织物结构的稳定性。②If the radial direction of the leaflet corresponds to the warp direction of the fabric, and the circumferential direction of the leaflet corresponds to the weft direction of the fabric, then the free edge is a special weft selvedge. The detachment phenomenon that may be caused by cutting is avoided (recorded in the prior art), which is beneficial to maintain the stability of the fabric structure.

(2)利用激光切割或超声切割形成。(2) It is formed by laser cutting or ultrasonic cutting.

(3)利用机械切割、激光切割或超声切割结合涂层形成；(3) Formed by mechanical cutting, laser cutting or ultrasonic cutting combined with coating;

(4)在织造前于自由边切割处附近配置多根熔点较热塑性高分子纱线低的纱线，例如低熔点氨纶、低熔点且降解周期长的可降解纱线，便于下机后在对热塑性高分子纱线进行热定型的同时对自由边进行熔融封边；所述热定型的目的是提高织物的结构稳定性。(4) Arrange multiple yarns with a lower melting point than thermoplastic polymer yarns near the free edge cut before weaving, such as low-melting spandex, degradable yarns with low melting point and long degradation cycle, so that it is convenient to adjust the yarn after getting off the machine. The thermoplastic polymer yarn is heat-set while the free edge is melt-sealed; the purpose of the heat-setting is to improve the structural stability of the fabric.

(5)织造完成后，在切割自由边时，保留一段不含金属丝的织物，其中，与作为瓣叶的织物相连接的一端被当作瓣叶的自由边，将其沿径向对折，利用缝合线将其游离的末端缝合至作为瓣叶或瓣叶主体的织物上；所述不含金属丝的织物在径向方向上长1.5～4mm。(5) After weaving is completed, when cutting the free edge, keep a piece of fabric without metal wires, wherein the end connected with the fabric as the leaflet is regarded as the free edge of the leaflet, and it is folded in half along the radial direction, The free ends thereof are sutured to the fabric serving as the leaflet or the body of the leaflet with sutures; the wire-free fabric is 1.5-4 mm long in the radial direction.

所述径向增强的纺织基人工心脏瓣膜除包含纺织基瓣叶外，还包含与所述纺织基瓣叶利用缝合线连接的裙边、支架或者人造血管；The radially reinforced textile-based artificial heart valve includes, in addition to the textile-based valve leaflet, a skirt, a stent or an artificial blood vessel that is connected with the textile-based valve leaflet by a suture;

如上所述的一种径向增强的纺织基人工心脏瓣膜，所述径向增强的纺织基人工心脏瓣膜的制造方式有以下几种：A kind of radially reinforced textile-based artificial heart valve as described above, the manufacturing methods of the radially reinforced textile-based artificial heart valve are as follows:

方法1：将片状织物裁剪为两或三片独立或相连的半月形瓣叶，然后结合裙边缝合至支架上，或缝合至人工血管内。Method 1: The sheet-like fabric is cut into two or three independent or connected half-moon-shaped valve leaflets, and then combined with the skirt and sutured to the stent, or sutured into the artificial blood vessel.

方法2：将片状织物热定型为两或三个具有瓣叶“零压力”状态下(瓣叶刚好相互接合时)的曲面形状，然后结合裙边缝合至支架上，或缝合至人工血管内。Method 2: Heat-set the sheet fabric into two or three curved shapes with leaflets in a "zero pressure" state (when the leaflets are just engaged with each other), and then sutured to the stent with the skirt, or sutured into the artificial blood vessel .

方法3：将片状织物的两侧缝合起来形成管状织物，利用管状织物和单点连接(Single point attached commissures,SPAC)缝合方式，结合裙边缝合至支架上，或缝合至人工血管内。Method 3: sew the two sides of the sheet fabric together to form a tubular fabric, and use the tubular fabric and the single point attached commissures (SPAC) suturing method to sew the skirt to the stent, or sew into the artificial blood vessel.

方法4：通过机织技术构建无缝管状织物；利用管状织物和单点连接(Singlepoint attached commissures,SPAC)缝合方式，结合裙边缝合至支架上，或缝合至人工血管内。Method 4: Constructing seamless tubular fabrics by weaving technology; using tubular fabrics and single point attached commissures (SPAC) sutures, combined with skirts and sutured to stents, or sutured into artificial blood vessels.

方法5：利用管状织物，结合模具和热定型工艺，得到三片瓣叶刚好接合时的曲面形状，然后，结合裙边缝合至支架上，或缝合至人工血管内。Method 5: Using a tubular fabric, combined with a mold and a heat-setting process, the curved shape of the three leaflets when they are just joined is obtained, and then combined with the skirt and sutured to the stent, or sutured into the artificial blood vessel.

方法6：将片状织物的两侧缝合起来形成管状织物，将管状织物向内或向外对折，形成内层管和外层管，沿轴向将内外层缝合起来，形成两条或三条纵向缝合连接线，从而将内层限定为了两或三个在两层贴合状态下为矩形、分离状态下呈“袋状”的瓣叶形状。其中，内层管中作为自由边的一边未与外层连接。最后将外层管缝合至支架上或人工血管内；Method 6: Sew the two sides of the sheet fabric together to form a tubular fabric, fold the tubular fabric inward or outward to form an inner tube and an outer tube, and sew the inner and outer layers along the axial direction to form two or three longitudinal strips The connecting lines are sutured, thereby defining the inner layer into two or three leaflet shapes that are rectangular in the two-layered state and "pocket-like" in the separated state. Among them, the free side of the inner layer tube is not connected to the outer layer. Finally, the outer tube is sutured to the stent or artificial blood vessel;

方法7：将片状织物的两侧缝合起来形成管状织物，将管状织物向内或向外对折，形成内层管和外层管，缝合出具有两或三个相连的、完整的瓣叶底部曲线，从而更好地限定瓣叶的几何形状；其中，内层管中作为自由边的一边未与外层连接。最后将外层管缝合至支架上或人工血管内；Method 7: Sew the two sides of the sheet fabric together to form a tubular fabric, fold the tubular fabric inwards or outwards to form an inner tube and an outer tube, and sew out the bottom with two or three connected, complete leaflets curve to better define the geometry of the leaflets; wherein the side of the inner tube that is a free edge is not connected to the outer layer. Finally, the outer tube is sutured to the stent or artificial blood vessel;

方法8：在另一种实施例中，还可以将6中的缝合连接的方式改为在织造过程中通过经纬交织进行连接，连接强度与织物强度相近。即，在双幅织物或多层管状中，利用经纬纱上下接结的方式构成直线无缝连接线。Method 8: In another embodiment, the suture connection in 6 can also be changed to connect by warp and weft interlacing during the weaving process, and the connection strength is similar to the strength of the fabric. That is, in a double-width fabric or a multi-layered tubular shape, a straight seamless connection line is formed by using the warp and weft yarns to be bound up and down.

本发明的增强纱线对瓣叶的机械性能以及瓣膜的血流动力学性能和耐久性起到了积极作用，各项性能测试结果如下：The reinforcing yarn of the present invention has played a positive role in the mechanical properties of the valve leaflets and the hemodynamic performance and durability of the valve, and the performance test results are as follows:

1、瓣叶的机械性能1. Mechanical properties of leaflets

如上所述的一种径向增强的纺织基人工心脏瓣膜，径向增强的纺织基瓣叶的抗弯刚度为0.8～2.5mN·mm；断裂强度为5～577MPa，弹性模量为5～1286MPa；所述径向增强的纺织基瓣叶与对比样相比，径向机械性能表现出不同程度的提高：抗弯刚度为对比样的1.06～1.23倍，急弹性回复角比对比样大10～80°，断裂强度为对比样的1.10～1.37倍，弹性模量为对比样的1.19～2.51倍；所述对比样与所述纺织基瓣叶的区别仅在于用所述高分子纱线替换所述增强纱线。A radially reinforced textile-based artificial heart valve as described above, the radially reinforced textile-based valve leaflet has a bending stiffness of 0.8 to 2.5 mN mm, a breaking strength of 5 to 577 MPa, and an elastic modulus of 5 to 1286 MPa Compared with the control sample, the radially reinforced textile base leaflet shows different degrees of improvement in radial mechanical properties: the bending stiffness is 1.06-1.23 times that of the control sample, and the acute elastic recovery angle is 10-10 times larger than that of the control sample. 80°, the breaking strength is 1.10-1.37 times that of the comparison sample, and the elastic modulus is 1.19-2.51 times that of the comparison sample; the difference between the comparison sample and the textile base leaflet is only that the polymer yarn is used to replace the Reinforcing yarn.

由此可知，弯曲性能结果表明，瓣叶的抗弯刚度增加不明显且保持在较小范围内，说明增强纱线的织入对瓣叶的柔韧性的影响不大，使得瓣叶仍能在舒张期的主动脉压下较易闭合，对返流量的影响不大；急弹性回复角明显增大，说明瓣叶的弯曲回弹性显著增加，瓣膜在收缩期可快速响应两侧压差的变化，迅速打开且开口面积大，使得血液快速、顺利流出，表现为血流动力学参数中的有效开口面积增大且平均跨瓣压差减小，另外，与对比样相比，同一时刻开口面积更大且维持最大开口面积的时间长；拉伸性能结果表明，瓣叶的断裂强度在一定程度上有所增加，弹性模量显著增加，有利于增强瓣叶的力学支撑性，使其能够承受舒张期较高的血压，不出现破裂、脱垂、塌陷等不良现象；另外，弹性模量的显著增加对提高瓣叶在开合运动中的稳定性有积极影响，可避免厚度很小时出现抖动/拍打现象。It can be seen that the bending performance results show that the bending stiffness of the valve leaflet does not increase significantly and remains within a small range, indicating that the weaving of the reinforcing yarn has little effect on the flexibility of the valve leaflet, so that the valve leaflet can still be The aortic pressure in diastole is easier to close, and has little effect on the regurgitant flow; the sharp elastic recovery angle increases significantly, indicating that the bending resilience of the valve leaflets increases significantly, and the valve can quickly respond to changes in the pressure difference on both sides during systole , which opens rapidly and has a large opening area, which makes the blood flow out quickly and smoothly, which is manifested as an increase in the effective opening area in the hemodynamic parameters and a decrease in the average transvalvular pressure difference. In addition, compared with the control sample, the opening area at the same time It is larger and maintains the maximum opening area for a long time; the tensile performance results show that the breaking strength of the leaflet increases to a certain extent, and the elastic modulus increases significantly, which is beneficial to enhance the mechanical support of the leaflet and enable it to withstand High blood pressure during diastole, no adverse phenomena such as rupture, prolapse, and collapse; in addition, the significant increase in elastic modulus has a positive effect on improving the stability of valve leaflets during opening and closing movements, which can avoid jitter when the thickness is very small /slap phenomenon.

2、瓣膜的血流动力学性能2. Hemodynamic performance of the valve

如上所述的一种径向增强的纺织基人工心脏瓣膜，所述径向增强的纺织基人工心脏瓣膜具有优异的血流动力学性能，经体外脉动流性能测试机检测，径向增强的纺织基人工心脏瓣膜的有效开口面积为1.5～2.8cm²，返流分数＜15％，平均跨瓣压差＜10mmHg，均满足GB 12279-2008国家标准和ISO 5840国际标准；所述径向增强的纺织基人工心脏瓣膜与对比样相比，血流动力学性能指标表现出不同程度的提高：有效开口面积(EOA)为对比样的1.05～1.36倍，平均跨瓣压差(MDP)为对比样的0.68～1.00倍；在收缩期可快速响应两侧压差的变化：同一时刻下的开口面积为对比样的1.00～1.42倍，维持最大开口面积的时间为对比样的1.10～1.50倍。A radially reinforced textile-based artificial heart valve as described above, the radially reinforced textile-based artificial heart valve has excellent hemodynamic performance, and is detected by an in vitro pulsatile flow performance testing machine. The effective opening area of the basic artificial heart valve is 1.5-2.8 cm² , the regurgitation fraction is less than 15%, and the average transvalvular pressure difference is less than 10 mmHg, all of which meet the GB 12279-2008 national standard and ISO 5840 international standard; the radially enhanced Compared with the control sample, the hemodynamic performance indicators of the textile-based artificial heart valve showed different degrees of improvement: the effective opening area (EOA) was 1.05-1.36 times that of the control sample, and the mean transvalvular pressure difference (MDP) was the control sample. 0.68-1.00 times of the pressure difference between the two sides during systole: the opening area at the same time is 1.00-1.42 times that of the control sample, and the time to maintain the maximum opening area is 1.10-1.50 times that of the control sample.

3、瓣膜的耐久性3. Durability of the valve

如上所述的一种径向增强的纺织基人工心脏瓣膜，与对比样相比，有限元分析所得高分子材料部分的应力、应变数值表现出不同程度的降低：最大等效应力为对比样的0.39～0.87倍，最大等效应变为对比样的0.46～0.85倍。For a radially reinforced textile-based artificial heart valve as described above, compared with the control sample, the stress and strain values of the polymer material obtained by the finite element analysis show different degrees of reduction: the maximum equivalent stress is the control sample. 0.39-0.87 times, and the maximum equivalent effect becomes 0.46-0.85 times that of the control sample.

镍钛合金丝的疲劳强度大于558MPa(循环周期＞10⁷)，相较于普通医用高分子材料而言具有极其优异的疲劳强度，故增强纱线的引入有效缓解了高分子材料上的应力集中现象，对瓣膜耐久性的提高具有重要影响。The fatigue strength of nickel-titanium alloy wire is greater than 558MPa (cycle period>10⁷ ), which is extremely excellent compared to ordinary medical polymer materials. Therefore, the introduction of reinforcing yarns can effectively alleviate the stress concentration on polymer materials. This phenomenon has an important impact on the improvement of valve durability.

本发明的机理如下：The mechanism of the present invention is as follows:

本发明的纺织基瓣叶中的主体织物利用机织技术制得，且以高分子纱线和金属丝为原料。特别地，多数纱线为高分子纱线，赋予瓣叶材料极薄的厚度和良好的柔韧性(薄而柔韧)，从而有利于瓣膜经导管植入且在心动周期内保持灵活开闭。The main fabric in the textile base leaflet of the present invention is made by weaving technology, and uses polymer yarn and metal wire as raw materials. In particular, most of the yarns are polymer yarns, which endow the leaflet material with extremely thin thickness and good flexibility (thin and flexible), thereby facilitating transcatheter implantation of the valve and maintaining flexible opening and closing during the cardiac cycle.

相较于未增强的瓣叶，在瓣叶径向选择性地织入少量增强纱线，利用其超弹性、高强度、高模量、高耐疲劳性和高柔顺性等特性对瓣叶的机械性能和瓣膜的血流动力学性能、耐疲劳性起到以下四个方面的积极作用：Compared with the unreinforced valve leaflet, a small amount of reinforcing yarn is selectively woven into the valve leaflet in the radial direction, and its superelasticity, high strength, high modulus, high fatigue resistance and high flexibility are used to improve the valve leaflet. The mechanical properties, hemodynamic properties and fatigue resistance of the valve play a positive role in the following four aspects:

(1)利用金属丝的高模量，使得径向增强后的弹性模量增加，从而保证瓣叶在开合过程中具备优异的运动稳定性，保持良好的运动形态，避免出现波动/拍打现象；(1) The high modulus of the metal wire is used to increase the elastic modulus after radial reinforcement, so as to ensure that the valve leaflets have excellent movement stability during the opening and closing process, maintain a good movement shape, and avoid the phenomenon of fluctuation/beating ;

(2)利用金属丝的高强度和高模量，使得径向增强后的断裂强度和弹性模量增加，从而提高瓣叶的力学支撑性，避免其在舒张期较高的主动脉压力下出现破裂、脱垂或塌陷等不良现象；(2) Utilize the high strength and high modulus of the metal wire to increase the fracture strength and elastic modulus after radial enhancement, thereby improving the mechanical support of the valve leaflet and avoiding its appearance under the high aortic pressure during diastole. Undesirable phenomena such as rupture, prolapse or collapse;

(3)利用金属丝的高耐疲劳性，辅助承受瓣叶中高分子材料部分在循环开闭过程中所承受的拉伸、弯曲和剪切作用下的复合载荷，降低应力和应变，从而提高其耐久性；(3) Utilize the high fatigue resistance of the metal wire to assist in bearing the composite load under the tensile, bending and shearing action of the polymer material part in the valve leaflet during the cyclic opening and closing process, reduce stress and strain, and improve its performance. durability;

(4)利用金属丝的高柔顺性和超弹性，使得瓣叶弯曲刚度保持在较小数值范围内、在反向血流压力作用下较易关闭的前提下，增加瓣叶的折皱回复角，从而增加其弯曲回弹性，使得瓣叶在收缩早期具有主动由关闭状态回复至打开状态的趋势，快速响应压差的变化，同一时刻下的有效开口面积更大，且达到最大开口面积的时间更短，血流快速、顺利地流出。(4) Using the high flexibility and superelasticity of the metal wire, the bending stiffness of the valve leaflet is kept within a small value range, and under the premise that it is easier to close under the action of reverse blood flow pressure, the crease recovery angle of the valve leaflet is increased, Thereby increasing its bending resilience, so that the leaflet has a tendency to actively return from the closed state to the open state in the early stage of contraction, and responds quickly to the change of pressure difference, the effective opening area at the same time is larger, and the time to reach the maximum opening area is longer Short, the blood flow out quickly and smoothly.

另一方面，金属丝不同的贯穿区间将赋予瓣叶不同的机械性能和血流动力学性能。(1)当金属丝仅存在于瓣叶中时，可以具备上述作用1、2、3，此时，金属丝在瓣叶中的贯穿区间不同又将产生不同的效果：①当金属丝仅贯穿于瓣叶底部和腹部时，接合区和自由边均由高分子纱线交织而成，柔韧且质量轻，瓣叶在舒张期关闭速度更快且接合得更加紧密，返流量更少；②当金属丝由瓣叶底部贯穿至自由边时，可辅助承受接合区和自由边的载荷，提高瓣叶的耐久性；(2)当金属丝连续存在于瓣叶及其附件中，可以具备作用1、2、3、4。On the other hand, the different penetration intervals of the wire will give the valve leaflets different mechanical and hemodynamic properties. (1) When the metal wire only exists in the valve leaflet, it can have theabove functions 1, 2, and 3. At this time, different penetration intervals of the metal wire in the valve leaflet will produce different effects: ① When the metal wire only penetrates through the valve leaflet At the bottom and abdomen of the valve leaflet, the coaptation area and the free edge are interwoven with polymer yarns, which are flexible and light in weight. When the metal wire penetrates from the bottom of the leaflet to the free edge, it can assist in bearing the load of the coaptation area and the free edge, and improve the durability of the valve leaflet; (2) When the metal wire continuously exists in the valve leaflet and its accessories, it can play arole 1 , 2, 3, 4.

有益效果beneficial effect

(1)本发明的一种径向增强的纺织基人工心脏瓣膜，以不可降解的金属丝与不可降解或可降解的高分子纱线为原料，不可降解瓣叶将作为永久性的人工心脏瓣膜使用，可部分降解瓣叶将作为组织工程心脏瓣膜使用；另一方面，纺织基瓣叶与外科瓣、介入瓣的支架，或者带瓣管道的人造血管相连接，还可进一步扩宽应用范围；(1) A radially reinforced textile-based artificial heart valve of the present invention uses non-degradable metal wire and non-degradable or degradable polymer yarn as raw materials, and the non-degradable valve leaflet will be used as a permanent artificial heart valve When used, the partially degradable valve leaflet will be used as a tissue-engineered heart valve; on the other hand, the textile-based valve leaflet is connected to a surgical valve, a stent for an interventional valve, or an artificial blood vessel with a valved conduit, which can further expand the scope of application;

(2)本发明以高分子纱线和金属丝为原料，在保证瓣叶轻薄、具有一定柔韧性的前提下提高瓣叶的运动稳定性、力学支撑性、弯曲回弹性以及耐疲劳性，从而使得瓣膜具备更好的机械性能、血流动力学性能和耐久性。(2) The present invention uses polymer yarn and metal wire as raw materials, and improves the motion stability, mechanical support, bending resilience and fatigue resistance of the valve leaflet under the premise of ensuring that the valve leaflet is light and thin, and has a certain flexibility, thereby The valve has better mechanical properties, hemodynamic performance and durability.

附图说明Description of drawings

图1为本发明的径向增强的纺织基人工心脏瓣膜的整体结构示意图；1 is a schematic diagram of the overall structure of the radially reinforced textile-based artificial heart valve of the present invention;

图2为本发明的径向增强的纺织基人工心脏瓣膜的各区域的连接关系示意图；2 is a schematic diagram of the connection relationship of each region of the radially reinforced textile-based artificial heart valve of the present invention;

图3为本发明的瓣叶上增强纱线的分布A的示意图；Fig. 3 is the schematic diagram of the distribution A of the reinforcing yarn on the leaflet of the present invention;

图4为本发明的瓣叶上增强纱线的分布B的示意图；4 is a schematic diagram of the distribution B of reinforcing yarns on the leaflet of the present invention;

图5为本发明的瓣叶上增强纱线的分布E的示意图；5 is a schematic diagram of the distribution E of the reinforcing yarns on the leaflet of the present invention;

图6为本发明的瓣叶上增强纱线的贯穿方式I的结构示意图；Fig. 6 is the structural representation of the penetration mode I of the reinforcing yarn on the leaflet of the present invention;

图7为本发明的瓣叶上增强纱线的贯穿方式II的结构示意图；7 is a schematic structural diagram of the penetration mode II of the reinforcing yarn on the leaflet of the present invention;

图8为本发明的瓣叶上径向纱线与瓣叶径向中心轴的位置关系W1的示意图；8 is a schematic diagram of the positional relationship W1 of the radial yarn on the leaflet and the radial central axis of the leaflet of the present invention;

图9为本发明的瓣叶上径向纱线与瓣叶径向中心轴的位置关系W2的示意图9 is a schematic diagram of the positional relationship W2 between the radial yarns on the leaflet and the radial central axis of the leaflet according to the present invention

图10为本发明的瓣叶上径向纱线与瓣叶径向中心轴的位置关系W3的示意图；10 is a schematic diagram of the positional relationship W3 of the radial yarn on the leaflet and the radial central axis of the leaflet of the present invention;

图11为本发明的瓣叶上径向纱线与瓣叶径向中心轴的位置关系W4的示意图；11 is a schematic diagram of the positional relationship W4 of the radial yarn on the leaflet and the radial central axis of the leaflet of the present invention;

图12为本发明的瓣叶上径向纱线与瓣叶径向中心轴的位置关系W5的示意图；12 is a schematic diagram of the positional relationship W5 of the radial yarn on the leaflet and the radial central axis of the leaflet of the present invention;

图13为本发明的瓣叶上径向纱线与瓣叶径向中心轴的位置关系W6的示意图；13 is a schematic diagram of the positional relationship W6 of the radial yarn on the leaflet and the radial central axis of the leaflet of the present invention;

图14为本发明的瓣叶上径向纱线与瓣叶径向中心轴的位置关系W7的示意图；14 is a schematic diagram of the positional relationship W7 of the radial yarn on the leaflet and the radial central axis of the leaflet of the present invention;

图15为本发明的瓣叶上径向纱线与瓣叶径向中心轴的位置关系W8的示意图；15 is a schematic diagram of the positional relationship W8 of the radial yarn on the leaflet and the radial central axis of the leaflet of the present invention;

图16为实施例1中组装后的人工心脏瓣膜的结构示意图；16 is a schematic structural diagram of the assembled artificial heart valve in Example 1;

图17为实施例1中的三片瓣叶在闭合状态下的俯视图；17 is a top view of the three leaflets in Example 1 in a closed state;

图18为实施例1中的三片瓣叶在闭合状态下的斜视图；Figure 18 is a perspective view of the three leaflets in Example 1 in a closed state;

图19为实施例1中织物放大50倍后的SEM图；其中，黑色虚线框内为增强纱线；Figure 19 is the SEM image of the fabric in Example 1 aftermagnification 50 times; wherein, the black dotted frame is the reinforcing yarn;

图20为本发明的径向增强的纺织基人工心脏瓣膜的流体力学曲线图；Figure 20 is a hydrodynamic curve diagram of a radially reinforced textile-based artificial heart valve of the present invention;

其中，1-连接处，2-自由边，3-接合区，4-腹部，5-底部，6-高分子纱线，7-纱线间隙，8-增强纱线，9-单元，10-瓣叶，11-裙边，12-支架。Among them, 1-joint, 2-free edge, 3-joint area, 4-abdomen, 5-bottom, 6-polymer yarn, 7-yarn gap, 8-reinforced yarn, 9-unit, 10- Leaflet, 11-skirt, 12-stent.

具体实施方式Detailed ways

下面结合具体实施方式，进一步阐述本发明。应理解，这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解，在阅读了本发明讲授的内容之后，本领域技术人员可以对本发明作各种改动或修改，这些等价形式同样落于本申请所附权利要求书所限定的范围。The present invention will be further described below in conjunction with specific embodiments. It should be understood that these examples are only used to illustrate the present invention and not to limit the scope of the present invention. In addition, it should be understood that after reading the content taught by the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the appended claims of the present application.

本发明中所采用的测试方法如下：The test method adopted in the present invention is as follows:

(1)瓣叶的拉伸性能测试(1) Tensile performance test of valve leaflets

根据GB 12279-2008《心血管植入物人工心脏瓣膜》和ISO 5840-1:2015《心血管植入物.心脏瓣膜假体.第1部分：通用要求》，人工心脏瓣膜中关键的力学性能指标断裂强力和弹性模量需要满足一定的条件，故在采用YG(B)026G型电子织物强力仪上对瓣叶材料的径向进行测试。随机选取5个区域，每个区域剪取5mm×20mm的试样，设定拉伸速度为50mm/min，预加张力为0.1N，对试样进行拉伸直至断裂，根据测试数据计算出断裂强度和弹性模量，结果取平均值。According to GB 12279-2008 "Cardiovascular Implants Artificial Heart Valves" and ISO 5840-1:2015 "Cardiovascular Implants. Heart Valve Prostheses. Part 1: General Requirements", the key mechanical properties of artificial heart valves The index breaking strength and elastic modulus need to meet certain conditions, so the radial direction of the valve leaflet material is tested on the YG(B)026G electronic fabric strength tester. Randomly select 5 areas, cut a 5mm × 20mm sample from each area, set the tensile speed to 50mm/min, and the pre-tension to 0.1N, stretch the sample until it breaks, and calculate the break according to the test data. Strength and elastic modulus, the results are averaged.

(2)瓣叶的弯曲性能测试(2) Bending performance test of valve leaflets

采用悬臂弯曲测试仪(ASTM D1388-07A)，测量瓣叶径向的弯曲刚度，定量地表征其径向的弯曲变形能力。选取尺寸为10×75mm的矩形样品(10mm对应瓣叶周向，75mm对应瓣叶径向)，每个样品的一端放置在光滑的低摩擦水平平台上，另一端下方有41.5”(0.724rad)的可调弯曲角度指示针。将加重的载玻片放在样品上，并以恒定速率前进。当样品的前缘从平台突出时，它会在自身质量的作用下弯曲。一旦材料弯曲到足以接触弯曲角度指示器的程度，就停止测试。测量弯曲的长度，并根据B_exp＝W·C³计算弯曲模量，其中W＝织物重量(N/mm²),C＝弯曲长度(mm)，B_exp＝实验所得的弯曲刚度。A cantilever bending tester (ASTM D1388-07A) was used to measure the radial bending stiffness of the leaflet and quantitatively characterize its radial bending deformation capacity. Select a rectangular sample with a size of 10×75mm (10mm corresponds to the leaflet circumferential direction, 75mm corresponds to the leaflet radial direction), one end of each sample is placed on a smooth low friction horizontal platform, and the other end is 41.5” (0.724rad) below The adjustable bend angle indicator pin. Place the weighted glass slide on the sample and advance at a constant rate. As the leading edge of the sample protrudes from the platform, it bends under the action of its own mass. Once the material is bent enough The degree of contact with the bend angle indicator, just stop the test. Measure the length of the bend, and calculate the flexural modulus according to B_exp = W · C³ , where W = fabric weight (N/mm² ), C = bending length (mm) , B_exp = experimental bending stiffness.

(3)瓣叶的折皱弹性测试(3) Wrinkle elasticity test of valve leaflets

采用YG541L型数字式织物折皱弹性仪，按照GB/T 3819-1997《纺织品织物折痕回复性的测定回复角法》，对瓣叶材料的径向进行测试。每种织物选取5块试样进行试验，裁剪成40mm×15mm的品字形，压力负荷为10cN，加压时间为5min。为防止测试过程中试样有黏附现象，影响测量结果，在两翼之间离折痕线2mm处放置1张厚度小于0.02mm的纸片或塑料薄膜。YG541L digital fabric crease elasticity tester was used to test the radial direction of the valve leaflet material in accordance with GB/T 3819-1997 "Determination of Recovery Angle Method for Crease Recovery of Textile Fabrics". Five samples of each fabric were selected for testing, cut into a 40mm × 15mm shape, the pressure load was 10cN, and the pressurization time was 5min. In order to prevent the sample from sticking during the test and affecting the measurement results, a piece of paper or plastic film with a thickness of less than 0.02mm is placed between the two wings at a distance of 2mm from the crease line.

(4)人工心脏瓣膜的流体力学性能测试(4) Hydrodynamic performance test of artificial heart valve

根据GB 12279-2008《心血管植入物人工心脏瓣膜》和ISO 5840-1:2015《心血管植入物.心脏瓣膜假体.第1部分：通用要求》，采用上海心瓣测试设备有限公司的MPD-1000型模块化人工心脏瓣膜脉动流性能测试机对制备的人工心脏瓣膜进行血流动力学性能检测。测试温度为37℃，使用的流体为生理盐水。设置心率＝70beat/min，模拟心输出量＝5L/min，平均主动脉压力＝100mmHg(保证主动脉收缩压＝120mmHg且舒张压＝80mmHg)，心脏收缩期(脉动前向流)百分比＝35％。检测10min内的模拟周期，由测试软件计算出生物瓣膜在上述参数条件下的脉动流特征参数，包括有效开口面积、返流百分比、平均跨瓣压差等。测试过程通过高速摄像机记录下来，利用IamgeJ图像处理软件计算收缩期内某一时刻下的开口面积。将收缩期的起点即为0cs，计算出第3.6cs(收缩早期)、20.1cs(收缩峰值)和32.5cs(收缩末期)下的瓣膜开口面积，以及基本维持最大开口面积的时间，用以表现径向增强后瓣叶快速响应压差的效果。According to GB 12279-2008 "Cardiovascular Implants and Prosthetic Heart Valves" and ISO 5840-1:2015 "Cardiovascular Implants. Heart Valve Prostheses. Part 1: General Requirements", using Shanghai Heart Valve Testing Equipment Co., Ltd. The MPD-1000 modular artificial heart valve pulsatile flow performance testing machine is used to test the hemodynamic performance of the prepared artificial heart valve. The test temperature was 37°C, and the fluid used was normal saline. Set heart rate=70beat/min, simulated cardiac output=5L/min, mean aortic pressure=100mmHg (guaranteed aortic systolic pressure=120mmHg and diastolic pressure=80mmHg), systolic (pulsatile forward flow) percentage=35% . The simulation period within 10 minutes was detected, and the pulsatile flow characteristic parameters of the biological valve under the above parameters were calculated by the test software, including the effective opening area, the percentage of regurgitation, and the average transvalvular pressure difference. The test process was recorded by a high-speed camera, and the opening area at a certain moment in the systolic period was calculated using the IamgeJ image processing software. The starting point of the systolic period is 0cs, and the valve opening area at 3.6cs (early systole), 20.1cs (peak systole) and 32.5cs (end systole), and the time to basically maintain the maximum opening area are calculated to express The effect of radial enhancement of the leaflet in rapid response to differential pressure.

在本发明的实施例中，在同一纺织基瓣叶中，增强纱线呈中心对称分布，具体的分布方式可以有以下几种：In the embodiment of the present invention, in the same textile base leaflet, the reinforcing yarns are distributed symmetrically in the center, and the specific distribution modes can be as follows:

分布A：均匀分布，即所述增强纱线8均匀地分布在所述径向纱线中(如图3所示)，其中放大图为高分子纱线6的分布，高分子纱线6之间为纱线间隙7；Distribution A: Uniform distribution, that is, the reinforcingyarns 8 are evenly distributed in the radial yarns (as shown in FIG. 3 ), wherein the enlarged view is the distribution of thepolymer yarns 6 . between is theyarn gap 7;

分布B：单元均匀分布，即单元9均匀地分布在所述径向纱线中；单元由多根相邻的增强纱线8组成；多根指增强纱线根数占所属单元内纱线总根数的50％以上；单元内纱线总根数为径向纱线总根数的3～20％；少数指高分子纱线6的根数不超过所属单元内所述增强纱线8根数总和的50％(如图4所示)；Distribution B: The units are evenly distributed, that is, the units 9 are evenly distributed in the radial yarns; the unit is composed of multiple adjacent reinforcingyarns 8; the number of multiple reinforcing yarns accounts for the total number of yarns in the unit. More than 50% of the number of yarns; the total number of yarns in the unit is 3-20% of the total number of radial yarns; a minority means that the number ofpolymer yarns 6 does not exceed the 8 reinforcing yarns in the unit. 50% of the sum of the numbers (as shown in Figure 4);

分布C：单元均匀分布，即单元均匀地分布在径向纱线中；单元由多根邻近的增强纱线及其间间隔的少数高分子纱线组成；多根指增强纱线根数占所属单元内纱线总根数的50％以上；单元内纱线总根数为径向纱线总根数的3～20％；少数指高分子纱线的根数不超过所属单元内所述增强纱线根数总和的50％；Distribution C: The units are uniformly distributed, that is, the units are evenly distributed in the radial yarns; the unit is composed of multiple adjacent reinforcing yarns and a few polymer yarns spaced between them; the number of multiple reinforcing yarns accounts for the unit to which they belong. More than 50% of the total number of inner yarns; the total number of yarns in a unit is 3-20% of the total number of radial yarns; a minority means that the number of polymer yarns does not exceed the reinforcing yarns in the unit to which they belong 50% of the total number of wires;

分布D：单元对称分布，即单元由中间向两侧按一定规律变化；按一定规律变化是指：单元的宽度、单元间的间距、单元内的增强纱线的根数、单元内增强纱线的直径大小呈单调递增或单调递减。Distribution D: The unit is symmetrically distributed, that is, the unit changes according to a certain rule from the middle to the two sides; the change according to a certain rule refers to: the width of the unit, the spacing between the units, the number of reinforcing yarns in the unit, and the reinforcing yarns in the unit. The size of the diameter is monotonically increasing or monotonically decreasing.

分布E：单元对称分布，即单元9由中间向两侧按一定规律变化；按一定规律变化是指：单元内所述增强纱线8的数量按照一定规律变化(如图5所示)；增强纱线的种类包括其包含的金属丝或高分子纤维的种类。Distribution E: The unit is symmetrically distributed, that is, the unit 9 changes according to a certain law from the middle to the two sides; the change according to a certain law means: the number of the reinforcingyarns 8 in the unit changes according to a certain law (as shown in Figure 5); The kind of yarn includes the kind of metal wire or polymer fiber it contains.

在本发明的实施例中，纺织基瓣叶在平面状态下，径向纱线与瓣叶径向中心对称轴(即图中的径向中心线)的夹角为0°、30°或45°，具体地：In the embodiment of the present invention, when the textile base leaflet is in a plane state, the angle between the radial yarn and the radial center symmetry axis of the leaflet (ie, the radial centerline in the figure) is 0°, 30° or 45° °, specifically:

位置关系W1：当夹角为0°时，属于常规机织物结构，经纱和纬纱的交织角度为90°，如图8所示；Positional relationship W1: when the included angle is 0°, it belongs to the conventional woven fabric structure, and the interlacing angle of warp and weft is 90°, as shown in Figure 8;

位置关系W2：当夹角为0°时，在位置关系W1的基础上，将经纬纱颠倒了顺序(如图9所示)；Positional relationship W2: When the included angle is 0°, on the basis of the positional relationship W1, the warp and weft yarns are reversed (as shown in Figure 9);

位置关系W3：当夹角为45°时，属于常规机织物结构，经纱和纬纱的交织角度为90°，如图10所示；Positional relationship W3: when the included angle is 45°, it belongs to the conventional woven fabric structure, and the interlacing angle of warp and weft is 90°, as shown in Figure 10;

位置关系W4：当夹角为45°时，在位置关系W3的基础上，将经纬纱颠倒了顺序(如图11所示)；Positional relationship W4: When the included angle is 45°, on the basis of the positional relationship W3, the warp and weft yarns are reversed (as shown in Figure 11);

位置关系W5：当夹角为30°时，属于平面三向织物结构，采用两个系统的经纱(均为径向纱线)+一个系统的纬纱(如图12所示)，各纱线相互相交的角度为60°；Positional relationship W5: When the included angle is 30°, it belongs to a plane three-way fabric structure, using two systems of warp yarns (both radial yarns) + one system of weft yarns (as shown in Figure 12), each yarn is mutually The angle of intersection is 60°;

位置关系W6：当夹角为30°时，属于平面三向织物结构，采用两个系统的经纱+一个系统的纬纱(如图13所示)，各纱线相互相交的角度为60°，一个系统的经纱和一个系统的纬纱为径向纱线。Positional relationship W6: When the included angle is 30°, it belongs to a planar three-way fabric structure, using two systems of warp yarns + one system of weft yarns (as shown in Figure 13), the angle at which each yarn intersects is 60°, and one The warp yarns of a system and the weft yarns of a system are radial yarns.

位置关系W7：当夹角为30°时，属于平面三向织物结构，采用一个系统的经纱+两个系统的纬纱(如图14所示)，一个系统的经纱和一个系统的纬纱为径向纱线；Positional relationship W7: When the included angle is 30°, it belongs to a plane three-way fabric structure, using one system of warp yarns + two systems of weft yarns (as shown in Figure 14), one system of warp yarns and one system of weft yarns are radial yarn;

位置关系W8：当夹角为30°时，属于平面三向织物结构，采用一个系统的经纱+两个系统的纬纱(均为径向纱线)(如图15所示)；Positional relationship W8: when the included angle is 30°, it belongs to a plane three-way fabric structure, using one system of warp yarns + two systems of weft yarns (both radial yarns) (as shown in Figure 15);

在本发明的实施例中，增强纱线在瓣叶上有6种贯穿方式，具体为：In the embodiment of the present invention, the reinforcing yarn has 6 kinds of penetration modes on the leaflet, specifically:

贯穿方式I：连续贯穿底部(长度为a)+腹部(长度为b)，如图6所示；Penetration method I: continuous through the bottom (length a) + abdomen (length b), as shown in Figure 6;

贯穿方式II：连续贯穿底部(长度为a)+腹部(长度为b)+接合区(长度为c)；Penetration mode II: continuous penetration through the bottom (length a) + abdomen (length b) + junction (length c);

贯穿方式III：连续贯穿底部(长度为a)+腹部(长度为b)+接合区(长度为c)+自由边(长度为d)，如图7所示；Penetration mode III: continuous penetration through the bottom (length is a) + abdomen (length is b) + joint area (length is c) + free edge (length is d), as shown in Figure 7;

贯穿方式IV：连续贯穿腹部(长度为b)+接合区(长度为c)+自由边(长度为d)；Penetration mode IV: continuous through the abdomen (length is b) + junction area (length is c) + free edge (length is d);

贯穿方式V：连续贯穿腹部(长度为b)+接合区(长度为c)；Penetration method V: continuous through the abdomen (length b) + junction (length c);

贯穿方式VI：连续贯穿腹部(长度为b)；Penetration method VI: continuous through the abdomen (length is b);

其中，a、b、c、d分别代表底部5、腹部4、接合区3和自由边2在径向方向上的长度。Among them, a, b, c, d represent the lengths of thebottom 5, theabdomen 4, thejoint area 3 and thefree edge 2 in the radial direction, respectively.

实施例1Example 1

一种径向增强的纺织基人工心脏瓣膜，作为经导管人工心脏瓣膜使用，如图16～18所示，该人工心脏瓣膜直径为21mm，其制造方式为方法5，包括自膨胀式镍钛合金支架13、支架内部的三个纺织基瓣叶10和裙边11，通过缝合点将三者连接在一起(远心端缝合的在圆周上均分分布的三点构成瓣叶间的连接处1)，从而实现瓣膜的结构稳定性和开闭功能；其中，该纺织基瓣叶，如图1～2所示，分为底部、腹部、接合区和自由边四个区域，由纺织基瓣叶径向上的径向纱线与纺织基瓣叶周向上的周向纱线交织而成的织物(组织结构见表3)；径向纱线由增强纱线(见表1和表3)和高分子纱线(见表表2和表3)组成；织造时，上机经密为600根/10cm，上机纬密为500根/10cm；且纺织基瓣叶在平面状态下，径向上的纱线与瓣叶径向中心对称轴的夹角为0°(位置关系为W1)，且增强纱线的根数占比为径向纱线总根数的10％；且在同一纺织基瓣叶中，增强纱线呈中心对称分布，且分布方式为均匀分布A；且增强纱线在瓣叶上的贯穿方式为贯穿方式III；图17、18分别为三片瓣叶在闭合状态下的俯视图和斜视图。A radially reinforced textile-based artificial heart valve, used as a transcatheter artificial heart valve, as shown in Figures 16-18, the artificial heart valve has a diameter of 21 mm, and its manufacturing method ismethod 5, including self-expanding nickel-titanium alloys The stent 13, the three textile-basedvalve leaflets 10 and theskirt 11 inside the stent are connected together by suture points (the three points sutured at the distal end that are equally distributed on the circumference constitute the connection between the valve leaflets 1 ). ), thereby realizing the structural stability and opening and closing function of the valve; wherein, the textile-based valve leaflet, as shown in Figures 1-2, is divided into four regions: the bottom, the abdomen, the commissure area and the free edge. The fabric in which the radial yarns on the radial direction are interwoven with the circumferential yarns on the circumference of the textile base leaflet (see Table 3 for the organization structure); the radial yarns are made of reinforcing yarns (see Table 1 and Table 3) and high Molecular yarns (see Table 2 and Table 3) are composed; when weaving, the warp density of the upper machine is 600 pieces/10cm, and the weft density of the upper machine is 500 pieces/10cm; The angle between the yarn and the axis of symmetry of the radial center of the leaflet is 0° (the positional relationship is W1), and the number of reinforcing yarns accounts for 10% of the total number of radial yarns; and in the same textile base petal In the leaflet, the reinforcing yarns are distributed symmetrically in the center, and the distribution mode is uniform distribution A; and the penetration mode of the reinforcing yarns on the leaflet is the penetration mode III; Figures 17 and 18 are the three leaflets in the closed state, respectively. Top view and oblique view.

纺织基瓣叶的自由边为弧形；纺织基瓣叶的厚度为0.12mm；The free edge of the textile base leaflet is arc-shaped; the thickness of the textile base leaflet is 0.12mm;

该径向增强的纺织基瓣叶的抗弯刚度为1.2mN·mm；断裂强度为41.81MPa，弹性模量为568.10MPa；径向增强的纺织基瓣叶与对比样相比，径向机械性能表现出不同程度的提高：抗弯刚度为对比样的1.09倍，急弹性回复角比对比样大30°，断裂强度为对比样的1.15倍，弹性模量为对比样的1.59倍；对比样与所述纺织基瓣叶的区别仅在于用高分子纱线替换增强纱线。弯曲性能结果表明，瓣叶的抗弯刚度几乎不变并数值小，说明增强纱线的织入对瓣叶的柔韧性的影响不大，瓣叶在舒张期的主动脉压下仍能较易闭合；急弹性回复角明显增大，说明瓣叶的弯曲回弹性显著增加，瓣膜在收缩期可快速响应两侧压差的变化，迅速打开且开口面积大，使得血液快速、顺利流出；拉伸性能结果表明，瓣叶的断裂强度在一定程度上有所增加，弹性模量显著增加，有利于增强瓣叶的力学支撑性，使其能够承受舒张期较高的血压，不出现破裂、脱垂、塌陷等不良现象；另外，弹性模量的显著增加对提高瓣叶在开合运动中的稳定性有积极影响，可避免厚度很小时出现抖动/拍打现象。The flexural stiffness of the radially reinforced textile base leaflet is 1.2 mN mm; the breaking strength is 41.81 MPa, and the elastic modulus is 568.10 MPa; It shows different degrees of improvement: the flexural stiffness is 1.09 times that of the control sample, the rapid elastic recovery angle is 30° larger than that of the control sample, the breaking strength is 1.15 times that of the control sample, and the elastic modulus is 1.59 times that of the control sample. The textile base leaflets differ only by replacing the reinforcing yarns with polymeric yarns. The bending performance results show that the bending stiffness of the valve leaflet is almost unchanged and the value is small, indicating that the weaving of the reinforcing yarn has little effect on the flexibility of the valve leaflet, and the valve leaflet can still be easier under the aortic pressure during diastole. Closed; the acute elastic recovery angle increased significantly, indicating that the bending resilience of the valve leaflets increased significantly, the valve can quickly respond to changes in the pressure difference on both sides during systole, and the valve opens quickly and has a large opening area, allowing blood to flow out quickly and smoothly; stretching The performance results show that the breaking strength of the valve leaflets has increased to a certain extent, and the elastic modulus has increased significantly, which is conducive to enhancing the mechanical support of the valve leaflets, enabling them to withstand high blood pressure during diastole without rupture and prolapse. , collapse and other undesirable phenomena; in addition, the significant increase in the elastic modulus has a positive impact on improving the stability of the valve leaflet in the opening and closing movement, which can avoid the jitter/beat phenomenon when the thickness is very small.

如图20所示，径向增强的纺织基人工心脏瓣膜具有优异的血流动力学性能，经体外脉动流性能测试机检测，径向增强的纺织基人工心脏瓣膜的有效开口面积为1.98cm²，返流分数为10.58％，平均跨瓣压差为4.12mmHg，均满足GB 12279-2008国家标准和ISO 5840国际标准；与瓣叶的各项力学性能测试结果相匹配，径向增强的纺织基人工心脏瓣膜的有效开口面积大且平均跨瓣压差小(在收缩期易打开)，返流分数小(在舒张期较易关闭)，运动稳定且力学支撑性好(不存在抖动、坍塌现象)。与对比样相比，其血流动力学性能指标表现出不同程度的提高：有效开口面积(EOA)为对比样的1.13倍，平均跨瓣压差(MDP)为对比样的0.95倍；在收缩期可快速响应两侧压差的变化：同一时刻下的开口面积为对比样的1.00～1.42倍，各时刻的开口面积与对比样的倍数关系见表4，维持最大开口面积的时间为对比样的1.15倍。As shown in Figure 20, the radially reinforced textile-based artificial heart valve has excellent hemodynamic performance, and the effective opening area of the radially reinforced textile-based artificial heart valve is 1.98 cm² detected by the in vitro pulsatile flow performance testing machine. , the regurgitation fraction is 10.58%, and the average transvalvular pressure difference is 4.12mmHg, all of which meet the national standard of GB 12279-2008 and the international standard of ISO 5840; match the test results of various mechanical properties of the valve leaflets, and the radially reinforced textile base The prosthetic heart valve has a large effective opening area and a small average transvalvular pressure difference (easy to open in systole), small regurgitation fraction (easy to close in diastole), stable movement and good mechanical support (no shaking or collapse). ). Compared with the control sample, its hemodynamic performance indicators showed different degrees of improvement: the effective opening area (EOA) was 1.13 times that of the control sample, and the mean transvalvular pressure difference (MDP) was 0.95 times that of the control sample; It can quickly respond to the change of the pressure difference between the two sides: the opening area at the same time is 1.00 to 1.42 times that of the control sample. The relationship between the opening area at each time and the multiple of the control sample is shown in Table 4, and the time to maintain the maximum opening area is the control sample. 1.15 times.

与对比样相比，有限元分析所得径向增强的纺织基人工心脏瓣膜中高分子材料部分的应力、应变数值表现出不同程度的降低：最大等效应力为对比样的0.76倍，最大等效应变为对比样的0.75倍。这说明具备增强纱线的引入有效缓解了高分子材料上的应力集中现象，对瓣膜耐久性的提高具有重要影响。Compared with the control sample, the stress and strain values of the polymer material in the radially reinforced textile-based artificial heart valve obtained by finite element analysis showed different degrees of reduction: the maximum equivalent stress was 0.76 times that of the control sample, and the maximum equivalent strain It is 0.75 times of the comparison sample. This shows that the introduction of reinforced yarns can effectively alleviate the stress concentration phenomenon on the polymer material, which has an important impact on the improvement of valve durability.

实施例2Example 2

一种径向增强的纺织基人工心脏瓣膜，作为外科瓣使用，该人工心脏瓣膜直径为21mm，包括三个纺织基瓣叶，其中，该纺织基瓣叶，分为底部、腹部、接合区和自由边四个区域，由纺织基瓣叶径向上的径向纱线与纺织基瓣叶周向上的周向纱线交织而成的织物(组织结构见表3)；径向纱线由增强纱线(见表1和表3)和高分子纱线(见表2和表3)组成；织造时，上机经密为450根/10cm，上机纬密为450根/10cm；且纺织基瓣叶在平面状态下，径向上的纱线与瓣叶径向中心对称轴的夹角为0°(位置关系为W3)，且增强纱线的根数占比为径向纱线总根数的5％；且在同一纺织基瓣叶中，增强纱线呈中心对称分布，且分布方式为均匀分布A；且增强纱线在瓣叶上的贯穿方式为贯穿方式II；A radially reinforced textile-based artificial heart valve, used as a surgical valve, the artificial heart valve has a diameter of 21 mm, and includes three textile-based valve leaflets, wherein the textile-based valve leaflet is divided into bottom, abdomen, commissure area and The four areas of the free edge are a fabric formed by interweaving the radial yarns in the radial direction of the textile base leaflet with the circumferential yarns in the circumferential direction of the textile base leaflet (see Table 3 for the organization structure); the radial yarns are made of reinforcing yarns yarn (see Table 1 and Table 3) and polymer yarn (see Table 2 and Table 3); when weaving, the warp density of the upper machine is 450 pieces/10cm, and the weft density of the upper machine is 450 pieces/10cm; When the leaflet is in a plane state, the angle between the radial yarn and the axis of symmetry of the radial center of the leaflet is 0° (the positional relationship is W3), and the number of reinforcing yarns accounts for the total number of radial yarns and in the same textile base leaflet, the reinforcing yarns are distributed symmetrically in the center, and the distribution mode is uniform distribution A; and the penetration mode of the reinforcing yarns on the leaflet is the penetration mode II;

纺织基瓣叶的自由边为弧形；纺织基瓣叶的厚度为0.13mm；The free edge of the textile base leaflet is arc-shaped; the thickness of the textile base leaflet is 0.13mm;

该径向增强的纺织基瓣叶的抗弯刚度为0.8mN·mm；断裂强度为50.43MPa，弹性模量为206.76MPa；径向增强的纺织基瓣叶与对比样相比，径向机械性能表现出不同程度的提高：抗弯刚度为对比样的1.06倍，急弹性回复角比对比样大10°，断裂强度为对比样的1.10倍，弹性模量为对比样的1.19倍；对比样与所述纺织基瓣叶的区别仅在于用高分子纱线替换增强纱线；The flexural rigidity of the radially reinforced textile base leaflet is 0.8 mN mm; the breaking strength is 50.43 MPa, and the elastic modulus is 206.76 MPa; compared with the control sample, the radial mechanical properties of the radially reinforced textile base leaflet It shows different degrees of improvement: the flexural stiffness is 1.06 times that of the control sample, the rapid elastic recovery angle is 10° larger than that of the control sample, the breaking strength is 1.10 times that of the control sample, and the elastic modulus is 1.19 times that of the control sample. The textile base leaflet differs only in that the reinforcing yarn is replaced with a polymer yarn;

径向增强的纺织基人工心脏瓣膜具有优异的血流动力学性能，经体外脉动流性能测试机检测，径向增强的纺织基人工心脏瓣膜的有效开口面积为2.08cm²，返流分数为8.20％，平均跨瓣压差为2.96mmHg，均满足GB 12279-2008国家标准和ISO 5840国际标准；径向增强的纺织基人工心脏瓣膜在舒张期快速关闭，在收缩期易打开，且不存在抖动、坍塌现象；径向增强的纺织基人工心脏瓣膜与对比样相比，血流动力学性能指标表现出不同程度的提高：有效开口面积(EOA)为对比样的1.05倍，平均跨瓣压差(MDP)为对比样的1.00倍；在收缩期可快速响应两侧压差的变化：同一时刻下的开口面积为对比样的1.00～1.42倍，各时刻的开口面积与对比样的倍数关系见表4；维持最大开口面积的时间为对比样的1.10倍；与对比样相比，有限元分析所得高分子材料部分的应力、应变数值表现出不同程度的降低：最大等效应力为对比样的0.87倍，最大等效应变为对比样的0.85倍。The radially-enhanced textile-based artificial heart valve has excellent hemodynamic performance, and the effective opening area of the radially-enhanced textile-based artificial heart valve is 2.08cm² and the regurgitation fraction is 8.20 as detected by the in vitro pulsatile flow performance testing machine. %, the average transvalvular pressure difference is 2.96mmHg, which both meet the national standard of GB 12279-2008 and the international standard of ISO 5840; the radially reinforced textile-based artificial heart valve closes rapidly in diastole, easy to open in systole, and there is no jitter Compared with the control sample, the radially reinforced textile-based artificial heart valve showed different degrees of improvement in the hemodynamic performance indicators: the effective opening area (EOA) was 1.05 times that of the control sample, and the average transvalvular pressure difference (MDP) is 1.00 times that of the control sample; it can quickly respond to changes in the pressure difference on both sides during systole: the opening area at the same time is 1.00 to 1.42 times that of the control sample. Table 4; the time to maintain the maximum opening area is 1.10 times that of the control sample; compared with the control sample, the stress and strain values of the polymer material obtained by the finite element analysis show different degrees of reduction: the maximum equivalent stress is the control sample 0.87 times, the maximum equivalent effect becomes 0.85 times that of the control sample.

实施例3Example 3

一种径向增强的纺织基人工心脏瓣膜，作为经导管人工心脏瓣膜使用，该人工心脏瓣膜直径为23mm，包括三个纺织基瓣叶；其中，该纺织基瓣叶，分为底部、腹部、接合区和自由边四个区域，由纺织基瓣叶径向上的径向纱线与纺织基瓣叶周向上的周向纱线交织而成的织物(组织结构见表3)；径向纱线由增强纱线(见表1和表3)和高分子纱线(见表表2和表3)组成；织造时，两个系统的经纱的上机经密均为350根/10cm，上机纬密为350根/10cm；且纺织基瓣叶在平面状态下，径向上的纱线与瓣叶径向中心对称轴的夹角为30°(位置关系为W5)，且增强纱线的根数占比为径向纱线总根数的15％；且在同一纺织基瓣叶中，增强纱线呈中心对称分布，且分布方式为单元均匀分布B；且增强纱线在瓣叶上的贯穿方式为贯穿方式I；A radially reinforced textile-based artificial heart valve, used as a transcatheter artificial heart valve, the artificial heart valve has a diameter of 23mm, and includes three textile-based valve leaflets; wherein, the textile-based valve leaflet is divided into bottom, abdomen, The four areas of the junction area and the free edge are a fabric formed by interweaving the radial yarns in the radial direction of the textile base leaflet with the circumferential yarns in the circumferential direction of the textile base leaflet (see Table 3 for the organization structure); radial yarns It is composed of reinforcing yarn (see Table 1 and Table 3) and polymer yarn (see Table 2 and Table 3); when weaving, the warp density of the warp yarns of the two systems is 350/10cm, The weft density is 350 pieces/10cm; and the textile base leaflet is in a planar state, the angle between the radial yarn and the radial center symmetry axis of the leaflet is 30° (the positional relationship is W5), and the root of the reinforcing yarn is In the same textile base leaflet, the reinforcing yarns are distributed symmetrically in the center, and the distribution method is uniform distribution B; and the reinforcing yarns on the leaflet are distributed symmetrically. The penetration method is penetration method I;

纺织基瓣叶的自由边为直线；纺织基瓣叶的厚度为0.13mm；The free edge of the textile base leaflet is a straight line; the thickness of the textile base leaflet is 0.13mm;

该径向增强的纺织基瓣叶的抗弯刚度为1.6mN·mm；断裂强度为576.97MPa，弹性模量为1285.45MPa；径向增强的纺织基瓣叶与对比样相比，径向机械性能表现出不同程度的提高：抗弯刚度为对比样的1.11倍，急弹性回复角比对比样大44°，断裂强度为对比样的1.19倍，弹性模量为对比样的1.74倍；对比样与所述纺织基瓣叶的区别仅在于用高分子纱线替换增强纱线；The flexural stiffness of the radially reinforced textile base leaflet is 1.6 mN mm; the breaking strength is 576.97 MPa, and the elastic modulus is 1285.45 MPa; the radial mechanical properties of the radially reinforced textile base leaflet are compared with the control sample It shows different degrees of improvement: the flexural stiffness is 1.11 times that of the control sample, the rapid elastic recovery angle is 44° larger than that of the control sample, the fracture strength is 1.19 times that of the control sample, and the elastic modulus is 1.74 times that of the control sample. The textile base leaflet differs only in that the reinforcing yarn is replaced with a polymer yarn;

径向增强的纺织基人工心脏瓣膜具有优异的血流动力学性能，经体外脉动流性能测试机检测，径向增强的纺织基人工心脏瓣膜的有效开口面积为2.13cm²，返流分数为10.76％，平均跨瓣压差为3.98mmHg，均满足GB 12279-2008国家标准和ISO 5840国际标准；径向增强的纺织基人工心脏瓣膜在舒张期快速关闭，在收缩期易打开，且不存在抖动、坍塌现象；径向增强的纺织基人工心脏瓣膜与对比样相比，血流动力学性能指标表现出不同程度的提高：有效开口面积(EOA)为对比样的1.19倍，平均跨瓣压差(MDP)为对比样的0.89倍；在收缩期可快速响应两侧压差的变化：同一时刻下的开口面积为对比样的1.00～1.42倍，各时刻的开口面积与对比样的倍数关系见表4；维持最大开口面积的时间为对比样的1.21倍；与对比样相比，有限元分析所得高分子材料部分的应力、应变数值表现出不同程度的降低：最大等效应力为对比样的0.65倍，最大等效应变为对比样的0.69倍。The radially-enhanced textile-based artificial heart valve has excellent hemodynamic performance. The effective opening area of the radially-enhanced textile-based artificial heart valve is 2.13 cm² and the regurgitation fraction is 10.76 as measured by the in vitro pulsatile flow performance testing machine. %, the average transvalvular pressure difference is 3.98mmHg, which both meet the national standard of GB 12279-2008 and the international standard of ISO 5840; the radially reinforced textile-based artificial heart valve closes rapidly in diastole, easy to open in systole, and there is no jitter Compared with the control sample, the radially reinforced textile-based artificial heart valve showed different degrees of improvement in the hemodynamic performance indicators: the effective opening area (EOA) was 1.19 times that of the control sample, and the average transvalvular pressure difference (MDP) is 0.89 times that of the control sample; it can quickly respond to changes in the pressure difference between the two sides during systole: the opening area at the same time is 1.00 to 1.42 times that of the control sample. Table 4; the time to maintain the maximum opening area is 1.21 times that of the control sample; compared with the control sample, the stress and strain values of the polymer material obtained by the finite element analysis show different degrees of reduction: the maximum equivalent stress is the control sample 0.65 times, the maximum equivalent effect becomes 0.69 times that of the control sample.

实施例4Example 4

一种径向增强的纺织基人工心脏瓣膜，作为外科瓣使用，该人工心脏瓣膜直径为25mm，包括两个纺织基瓣叶；其中，该纺织基瓣叶，分为底部、腹部、接合区和自由边四个区域，由纺织基瓣叶径向上的径向纱线与纺织基瓣叶周向上的周向纱线交织而成的织物(组织结构见表3)；径向纱线由增强纱线(见表1和表3)和高分子纱线(见表表2和表3)组成；织造时，上机经密为300根/10cm，上机纬密为300根/10cm；且纺织基瓣叶在平面状态下，径向上的纱线与瓣叶径向中心对称轴的夹角为45°(位置关系为W3)，且增强纱线的根数占比为径向纱线总根数的20％；且在同一纺织基瓣叶中，增强纱线呈中心对称分布，且分布方式为单元均匀分布C；且增强纱线在瓣叶上的贯穿方式为贯穿方式IV；A radially reinforced textile-based artificial heart valve used as a surgical valve, the artificial heart valve has a diameter of 25 mm, and includes two textile-based valve leaflets; wherein, the textile-based valve leaflet is divided into a bottom, an abdomen, a commissure area and a The four areas of the free edge are a fabric formed by interweaving the radial yarns in the radial direction of the textile base leaflet with the circumferential yarns in the circumferential direction of the textile base leaflet (see Table 3 for the organization structure); the radial yarns are made of reinforcing yarns yarn (see Table 1 and Table 3) and polymer yarn (see Table 2 and Table 3); when weaving, the warp density of the upper machine is 300 pieces/10cm, and the weft density of the upper machine is 300 pieces/10cm; In the plane state of the base leaflet, the angle between the radial yarn and the radial center symmetry axis of the leaflet is 45° (the positional relationship is W3), and the number of reinforcing yarns accounts for the total number of radial yarns. 20% of the number; and in the same textile base leaflet, the reinforcing yarns are distributed symmetrically in the center, and the distribution mode is the uniform distribution of cells C; and the penetration mode of the reinforcing yarns on the leaflet is the penetration mode IV;

纺织基瓣叶的自由边为弧形；纺织基瓣叶的厚度为0.18mm；The free edge of the textile base leaflet is arc-shaped; the thickness of the textile base leaflet is 0.18mm;

该径向增强的纺织基瓣叶的抗弯刚度为2.3mN·mm；断裂强度为187.09MPa，弹性模量为58.90MPa；径向增强的纺织基瓣叶与对比样相比，径向机械性能表现出不同程度的提高：抗弯刚度为对比样的1.13倍，急弹性回复角比对比样大59°，断裂强度为对比样的1.22倍，弹性模量为对比样的1.98倍；对比样与所述纺织基瓣叶的区别仅在于用高分子纱线替换增强纱线；The flexural stiffness of the radially reinforced textile base leaflet is 2.3 mN mm; the breaking strength is 187.09 MPa, and the elastic modulus is 58.90 MPa; It shows different degrees of improvement: the flexural stiffness is 1.13 times that of the control sample, the rapid elastic recovery angle is 59° larger than that of the control sample, the breaking strength is 1.22 times that of the control sample, and the elastic modulus is 1.98 times that of the control sample. The textile base leaflet differs only in that the reinforcing yarn is replaced with a polymer yarn;

径向增强的纺织基人工心脏瓣膜具有优异的血流动力学性能，经体外脉动流性能测试机检测，径向增强的纺织基人工心脏瓣膜的有效开口面积为1.56cm²，返流分数为12.98％，平均跨瓣压差为7.85mmHg，均满足GB 12279-2008国家标准和ISO 5840国际标准；径向增强的纺织基人工心脏瓣膜在舒张期快速关闭，在收缩期易打开，且不存在抖动、坍塌现象；径向增强的纺织基人工心脏瓣膜与对比样相比，血流动力学性能指标表现出不同程度的提高：有效开口面积(EOA)为对比样的1.10倍，平均跨瓣压差(MDP)为对比样的0.82倍；在收缩期可快速响应两侧压差的变化：同一时刻下的开口面积为对比样的1.00～1.42倍，各时刻的开口面积与对比样的倍数关系见表4；维持最大开口面积的时间为对比样的1.27倍；与对比样相比，有限元分析所得高分子材料部分的应力、应变数值表现出不同程度的降低：最大等效应力为对比样的0.60倍，最大等效应变为对比样的0.62倍。The radially reinforced textile-based prosthetic heart valve has excellent hemodynamic performance. The radially reinforced textile-based prosthetic heart valve has an effective opening area of 1.56 cm² and a regurgitation fraction of 12.98 as measured by an in vitro pulsatile flow performance tester. %, the average transvalvular pressure difference is 7.85mmHg, which both meet the national standard of GB 12279-2008 and the international standard of ISO 5840; the radially reinforced textile-based artificial heart valve closes rapidly in diastole, easy to open in systole, and there is no jitter Compared with the control sample, the radially reinforced textile-based artificial heart valve showed different degrees of improvement in the hemodynamic performance indicators: the effective opening area (EOA) was 1.10 times that of the control sample, and the average transvalvular pressure difference (MDP) is 0.82 times that of the control sample; it can quickly respond to changes in the pressure difference on both sides during systole: the opening area at the same time is 1.00-1.42 times that of the control sample. Table 4; the time to maintain the maximum opening area is 1.27 times that of the control sample; compared with the control sample, the stress and strain values of the polymer material obtained by the finite element analysis show different degrees of reduction: the maximum equivalent stress is the control sample 0.60 times, the maximum equivalent effect becomes 0.62 times that of the control sample.

实施例5Example 5

一种径向增强的纺织基人工心脏瓣膜，作为组织工程心脏瓣膜使用，以微创方式介入，该人工心脏瓣膜直径为21mm，包括三个纺织基瓣叶；其中，该纺织基瓣叶，分为底部、腹部、接合区和自由边四个区域，由纺织基瓣叶径向上的径向纱线与纺织基瓣叶周向上的周向纱线交织而成的织物(组织结构见表3)；径向纱线由增强纱线(见表1和表3)和高分子纱线(见表表2和表3)组成；织造时，上机经密为200根/10cm，上机纬密为300根/10cm；且纺织基瓣叶在平面状态下，径向上的纱线与瓣叶径向中心对称轴的夹角为0°(位置关系为W1)，且增强纱线的根数占比为径向纱线总根数的8％；且在同一纺织基瓣叶中；且增强纱线呈中心对称分布，且分布方式为单元均匀分布D；且增强纱线在瓣叶上的贯穿方式为贯穿方式III；A radially reinforced textile-based artificial heart valve, used as a tissue-engineered heart valve and intervening in a minimally invasive manner, the artificial heart valve has a diameter of 21 mm, and includes three textile-based valve leaflets; wherein, the textile-based valve leaflets are divided into It is a fabric formed by interweaving the radial yarns in the radial direction of the textile base leaflet with the circumferential yarns in the circumferential direction of the textile base leaflet (see Table 3 for organizational structure) ; Radial yarn is composed of reinforcing yarn (see Table 1 and Table 3) and polymer yarn (see Table 2 and Table 3); when weaving, the warp density of the upper machine is 200/10cm, and the weft density of the upper machine is 200 pieces/10cm. It is 300/10cm; and when the textile base leaflet is in a plane state, the angle between the radial yarn and the radial center symmetry axis of the leaflet is 0° (the positional relationship is W1), and the number of reinforcing yarns accounts for The ratio is 8% of the total number of radial yarns; and in the same textile base leaflet; and the reinforcing yarns are distributed symmetrically in the center, and the distribution method is uniform distribution of units D; and the penetration of the reinforcing yarns on the leaflets The way is through way III;

纺织基瓣叶的自由边为弧形；纺织基瓣叶的厚度为0.3mm；The free edge of the textile base leaflet is arc-shaped; the thickness of the textile base leaflet is 0.3mm;

该径向增强的纺织基瓣叶的抗弯刚度为1.5mN·mm；断裂强度为5.80MPa，弹性模量为5.09MPa；径向增强的纺织基瓣叶与对比样相比，径向机械性能表现出不同程度的提高：抗弯刚度为对比样的1.07倍，急弹性回复角比对比样大22°，断裂强度为对比样的1.12倍，弹性模量为对比样的1.35倍；对比样与所述纺织基瓣叶的区别仅在于用高分子纱线替换增强纱线；The flexural stiffness of the radially reinforced textile base leaflet is 1.5 mN mm; the breaking strength is 5.80 MPa, and the elastic modulus is 5.09 MPa; It shows different degrees of improvement: the flexural stiffness is 1.07 times that of the control sample, the rapid elastic recovery angle is 22° larger than that of the control sample, the breaking strength is 1.12 times that of the control sample, and the elastic modulus is 1.35 times that of the control sample. The textile base leaflet differs only in that the reinforcing yarn is replaced with a polymer yarn;

径向增强的纺织基人工心脏瓣膜具有优异的血流动力学性能，经体外脉动流性能测试机检测，径向增强的纺织基人工心脏瓣膜的有效开口面积为1.82cm²，返流分数为6.29％，平均跨瓣压差为3.69mmHg，均满足GB 12279-2008国家标准和ISO 5840国际标准；径向增强的纺织基人工心脏瓣膜在舒张期快速关闭，在收缩期易打开，且不存在抖动、坍塌现象；径向增强的纺织基人工心脏瓣膜与对比样相比，血流动力学性能指标表现出不同程度的提高：有效开口面积(EOA)为对比样的1.05倍，平均跨瓣压差(MDP)为对比样的0.97倍；在收缩期可快速响应两侧压差的变化：同一时刻下的开口面积为对比样的1.00～1.42倍，各时刻的开口面积与对比样的倍数关系见表4；维持最大开口面积的时间为对比样的1.13倍；与对比样相比，有限元分析所得高分子材料部分的应力、应变数值表现出不同程度的降低：最大等效应力为对比样的0.54倍，最大等效应变为对比样的0.81倍。The radially reinforced textile-based prosthetic heart valve has excellent hemodynamic performance. The radially reinforced textile-based prosthetic heart valve has an effective opening area of 1.82 cm² and a regurgitation fraction of 6.29 as measured by an in vitro pulsatile flow performance tester. %, the average transvalvular pressure difference is 3.69mmHg, which both meet the national standard of GB 12279-2008 and the international standard of ISO 5840; the radially reinforced textile-based artificial heart valve closes rapidly in diastole, easy to open in systole, and there is no jitter Compared with the control sample, the radially reinforced textile-based artificial heart valve showed different degrees of improvement in the hemodynamic performance indicators: the effective opening area (EOA) was 1.05 times that of the control sample, and the average transvalvular pressure difference (MDP) is 0.97 times that of the control sample; it can quickly respond to changes in the pressure difference on both sides during systole: the opening area at the same time is 1.00 to 1.42 times that of the control sample. Table 4; the time to maintain the maximum opening area is 1.13 times that of the control sample; compared with the control sample, the stress and strain values of the polymer material obtained by the finite element analysis show different degrees of reduction: the maximum equivalent stress is the control sample 0.54 times, the maximum equivalent effect becomes 0.81 times that of the control sample.

实施例6Example 6

一种径向增强的纺织基人工心脏瓣膜，作为组织工程心脏瓣膜使用，以微创方式介入，该人工心脏瓣膜直径为25mm，包括三个纺织基瓣叶，其中，该纺织基瓣叶，分为底部、腹部、接合区和自由边四个区域，由纺织基瓣叶径向上的径向纱线与纺织基瓣叶周向上的周向纱线交织而成的织物(组织结构见表3)；径向纱线由增强纱线(见表1和表3)和高分子纱线(见表表2和表3)组成；织造时，上机经密为150根/10cm，上机纬密为150根/10cm；且纺织基瓣叶在平面状态下，径向上的纱线与瓣叶径向中心对称轴的夹角为45°(位置关系为W3)，且增强纱线的根数占比为径向纱线总根数的30％；且在同一纺织基瓣叶中，增强纱线呈中心对称分布，且分布方式为均匀分布A；且增强纱线在瓣叶上的贯穿方式为贯穿方式V；A radially reinforced textile-based artificial heart valve, used as a tissue-engineered heart valve and intervened in a minimally invasive manner, the artificial heart valve has a diameter of 25 mm, and includes three textile-based valve leaflets, wherein the textile-based valve leaflets are divided into It is a fabric formed by interweaving the radial yarns in the radial direction of the textile base leaflet with the circumferential yarns in the circumferential direction of the textile base leaflet (see Table 3 for organizational structure) ; Radial yarn is composed of reinforcing yarn (see Table 1 and Table 3) and polymer yarn (see Table 2 and Table 3); when weaving, the warp density of the upper machine is 150 pieces/10cm, and the weft density of the upper machine is 150 pieces/10cm. It is 150/10cm; and when the textile base leaflet is in a plane state, the angle between the yarn in the radial direction and the axis of symmetry of the radial center of the leaflet is 45° (the positional relationship is W3), and the number of reinforcing yarns accounts for The ratio is 30% of the total number of radial yarns; and in the same textile base leaflet, the reinforcing yarns are distributed centrally symmetrically, and the distribution mode is uniform distribution A; and the penetration mode of the reinforcing yarns on the leaflet is Penetration mode V;

纺织基瓣叶的自由边为直线；纺织基瓣叶的厚度为0.16mm；The free edge of the textile base leaflet is a straight line; the thickness of the textile base leaflet is 0.16mm;

该径向增强的纺织基瓣叶的抗弯刚度为1.8mN·mm；断裂强度为10.94MPa，弹性模量为13.89MPa；径向增强的纺织基瓣叶与对比样相比，径向机械性能表现出不同程度的提高：抗弯刚度为对比样的1.16倍，急弹性回复角比对比样大64°，断裂强度为对比样的1.25倍，弹性模量为对比样的2.20倍；对比样与所述纺织基瓣叶的区别仅在于用高分子纱线替换增强纱线；The flexural stiffness of the radially reinforced textile base leaflet is 1.8 mN mm; the breaking strength is 10.94 MPa, and the elastic modulus is 13.89 MPa; It shows different degrees of improvement: the flexural stiffness is 1.16 times that of the control sample, the rapid elastic recovery angle is 64° larger than that of the control sample, the breaking strength is 1.25 times that of the control sample, and the elastic modulus is 2.20 times that of the control sample. The textile base leaflet differs only in that the reinforcing yarn is replaced with a polymer yarn;

径向增强的纺织基人工心脏瓣膜具有优异的血流动力学性能，经体外脉动流性能测试机检测，径向增强的纺织基人工心脏瓣膜的有效开口面积为2.69cm²，返流分数为14.65％，平均跨瓣压差为8.88mmHg，均满足GB 12279-2008国家标准和ISO 5840国际标准；径向增强的纺织基人工心脏瓣膜在舒张期快速关闭，在收缩期易打开，且不存在抖动、坍塌现象；径向增强的纺织基人工心脏瓣膜与对比样相比，血流动力学性能指标表现出不同程度的提高：有效开口面积(EOA)为对比样的1.24倍，平均跨瓣压差(MDP)为对比样的0.78倍；在收缩期可快速响应两侧压差的变化：同一时刻下的开口面积为对比样的1.00～1.42倍，各时刻的开口面积与对比样的倍数关系见表4；维持最大开口面积的时间为对比样的1.33倍；与对比样相比，有限元分析所得高分子材料部分的应力、应变数值表现出不同程度的降低：最大等效应力为对比样的0.49倍，最大等效应变为对比样的0.57倍。The radially reinforced textile-based prosthetic heart valve has excellent hemodynamic performance. The radially reinforced textile-based prosthetic heart valve has an effective opening area of 2.69 cm² and a regurgitation fraction of 14.65 as measured by an in vitro pulsatile flow performance tester. %, the average transvalvular pressure difference is 8.88mmHg, which both meet the national standard of GB 12279-2008 and the international standard of ISO 5840; the radially reinforced textile-based artificial heart valve closes rapidly in diastole, easy to open in systole, and there is no jitter Compared with the control sample, the radially reinforced textile-based artificial heart valve showed different degrees of improvement in the hemodynamic performance indicators: the effective opening area (EOA) was 1.24 times that of the control sample, and the average transvalvular pressure difference (MDP) is 0.78 times that of the control sample; it can quickly respond to changes in the pressure difference on both sides during systole: the opening area at the same time is 1.00 to 1.42 times that of the control sample. Table 4; the time to maintain the maximum opening area is 1.33 times that of the control sample; compared with the control sample, the stress and strain values of the polymer material obtained by the finite element analysis show different degrees of reduction: the maximum equivalent stress is the control sample 0.49 times, the maximum equivalent effect becomes 0.57 times that of the control sample.

实施例7Example 7

一种径向增强的纺织基人工心脏瓣膜，作为组织工程心脏瓣膜使用，以微创方式介入，该人工心脏瓣膜直径为23mm，包括三个纺织基瓣叶其中，该纺织基瓣叶，分为底部、腹部、接合区和自由边四个区域，由纺织基瓣叶径向上的径向纱线与纺织基瓣叶周向上的周向纱线交织而成的织物(组织结构见表3)；径向纱线由增强纱线(见表1和表3)和高分子纱线(见表表2和表3)组成；织造时，上机经密为2000根/10cm，上机纬密为2000根/10cm；且纺织基瓣叶在平面状态下，径向上的纱线与瓣叶径向中心对称轴的夹角为0°(位置关系为W1)，且增强纱线的根数占比为径向纱线总根数的50％；且在同一纺织基瓣叶中，增强纱线呈中心对称分布，且分布方式为单元均匀分布D；且增强纱线在瓣叶上的贯穿方式为贯穿方式VI；A radially reinforced textile-based artificial heart valve, used as a tissue-engineered heart valve and intervened in a minimally invasive manner, the artificial heart valve has a diameter of 23 mm, and includes three textile-based valve leaflets, wherein the textile-based valve leaflet is divided into The four areas of the bottom, abdomen, joint area and free edge, the fabric made of the radial yarns in the radial direction of the textile base leaflet and the circumferential yarns in the circumferential direction of the textile base leaflet (see Table 3 for the organization structure); The radial yarn is composed of reinforcing yarn (see Table 1 and Table 3) and polymer yarn (see Table 2 and Table 3); when weaving, the warp density of the upper machine is 2000 pieces/10cm, and the weft density of the upper machine is 2000/10cm; and the textile base leaflet is in a plane state, the angle between the radial yarn and the radial center symmetry axis of the leaflet is 0° (the positional relationship is W1), and the number of reinforcing yarns accounts for is 50% of the total number of radial yarns; and in the same textile base leaflet, the reinforcing yarns are distributed symmetrically in the center, and the distribution mode is the uniform distribution of units D; and the penetration mode of the reinforcing yarns on the leaflet is Through mode VI;

纺织基瓣叶的自由边为弧形；纺织基瓣叶的厚度为0.06mm；The free edge of the textile base leaflet is arc-shaped; the thickness of the textile base leaflet is 0.06mm;

径向增强的纺织基瓣叶的抗弯刚度为2.5mN·mm；断裂强度为13.98MPa，弹性模量为16.32MPa；径向增强的纺织基瓣叶与对比样相比，径向机械性能表现出不同程度的提高：抗弯刚度为对比样的1.23倍，急弹性回复角比对比样大80°，断裂强度为对比样的1.37倍，弹性模量为对比样的2.51倍；对比样与所述纺织基瓣叶的区别仅在于用高分子纱线替换增强纱线；The bending stiffness of the radially reinforced textile base leaflet is 2.5 mN mm; the breaking strength is 13.98 MPa, and the elastic modulus is 16.32 MPa; the radial mechanical performance of the radially reinforced textile base leaflet compared with the control sample Different degrees of improvement: the flexural stiffness is 1.23 times that of the control sample, the rapid elastic recovery angle is 80° larger than that of the control sample, the breaking strength is 1.37 times that of the control sample, and the elastic modulus is 2.51 times that of the control sample. The difference of the textile base leaflet is only that the reinforcing yarn is replaced by the polymer yarn;

径向增强的纺织基人工心脏瓣膜具有优异的血流动力学性能，经体外脉动流性能测试机检测，径向增强的纺织基人工心脏瓣膜的有效开口面积为2.78cm²，返流分数为13.90％，平均跨瓣压差为9.71mmHg，均满足GB 12279-2008国家标准和ISO 5840国际标准；径向增强的纺织基人工心脏瓣膜在舒张期快速关闭，在收缩期易打开，且不存在抖动、坍塌现象；径向增强的纺织基人工心脏瓣膜与对比样相比，血流动力学性能指标表现出不同程度的提高：有效开口面积(EOA)为对比样的1.36倍，平均跨瓣压差(MDP)为对比样的0.68倍；在收缩期可快速响应两侧压差的变化：同一时刻下的开口面积为对比样的1.00～1.42倍，各时刻的开口面积与对比样的倍数关系见表4；维持最大开口面积的时间为对比样的1.50倍；与对比样相比，有限元分析所得高分子材料部分的应力、应变数值表现出不同程度的降低：最大等效应力为对比样的0.39倍，最大等效应变为对比样的0.46倍。The radially reinforced textile-based prosthetic heart valve has excellent hemodynamic performance. Tested by an in vitro pulsatile flow performance testing machine, the radially reinforced textile-based prosthetic heart valve has an effective opening area of 2.78cm² and a regurgitation fraction of 13.90. %, the average transvalvular pressure difference is 9.71mmHg, which both meet the national standard of GB 12279-2008 and the international standard of ISO 5840; the radially reinforced textile-based artificial heart valve closes rapidly in diastole, easy to open in systole, and there is no jitter Compared with the control sample, the radially reinforced textile-based artificial heart valve showed different degrees of improvement in the hemodynamic performance indicators: the effective opening area (EOA) was 1.36 times that of the control sample, and the average transvalvular pressure difference (MDP) is 0.68 times that of the control sample; it can quickly respond to changes in the pressure difference on both sides during systole: the opening area at the same time is 1.00 to 1.42 times that of the control sample. The relationship between the opening area at each time and the multiple of the control sample is shown in Table 4; the time to maintain the maximum opening area is 1.50 times that of the control sample; compared with the control sample, the stress and strain values of the polymer material obtained by the finite element analysis show different degrees of reduction: the maximum equivalent stress is the control sample 0.39 times, the maximum equivalent effect becomes 0.46 times that of the control sample.

实施例8Example 8

一种径向增强的纺织基人工心脏瓣膜，作为带瓣管道使用，该人工心脏瓣膜直径为23mm，包括三个纺织基瓣叶，其中，该纺织基瓣叶，分为底部、腹部、接合区和自由边四个区域，由纺织基瓣叶径向上的径向纱线与纺织基瓣叶周向上的周向纱线交织而成的织物(组织结构见表3)；径向纱线由增强纱线(见表1和表3)和高分子纱线(见表表2和表3)组成；织造时，上机经密为1500根/10cm，上机纬密为1800根/10cm；且纺织基瓣叶在平面状态下，径向上的纱线与瓣叶径向中心对称轴的夹角为0°(对应位置关系W1)，且增强纱线的根数占比为径向纱线总根数的40％；且在同一纺织基瓣叶中，增强纱线呈中心对称分布，且分布方式为单元均匀分布E；且增强纱线在瓣叶上的贯穿方式为贯穿方式II；A radially reinforced textile-based artificial heart valve, used as a valved conduit, the artificial heart valve has a diameter of 23 mm, and includes three textile-based valve leaflets, wherein the textile-based valve leaflet is divided into a bottom, an abdomen, and a coaptation area and the four areas of the free edge, a fabric formed by interweaving the radial yarns in the radial direction of the textile base leaflet with the circumferential yarns in the circumferential direction of the textile base leaflet (see Table 3 for the organization structure); the radial yarns are reinforced by Yarn (see Table 1 and Table 3) and polymer yarn (see Table 2 and Table 3); when weaving, the warp density of the upper machine is 1500 pieces/10cm, and the weft density of the upper machine is 1800 pieces/10cm; and In the plane state of the textile base leaflet, the angle between the radial yarn and the axis of symmetry of the radial center of the leaflet is 0° (corresponding to the positional relationship W1), and the number of reinforcing yarns accounts for the total number of radial yarns. 40% of the number of roots; and in the same textile base leaflet, the reinforcing yarns are distributed symmetrically in the center, and the distribution mode is the unit uniform distribution E; and the penetration mode of the reinforcing yarns on the leaflet is the penetration mode II;

纺织基瓣叶的自由边为直线；纺织基瓣叶的厚度为0.08mm；The free edge of the textile base leaflet is a straight line; the thickness of the textile base leaflet is 0.08mm;

该径向增强的纺织基瓣叶的抗弯刚度为2.4mN·mm；断裂强度为106.82MPa，弹性模量为49.75MPa；径向增强的纺织基瓣叶与对比样相比，径向机械性能表现出不同程度的提高：抗弯刚度为对比样的1.20倍，急弹性回复角比对比样大72°，断裂强度为对比样的1.29倍，弹性模量为对比样的2.39倍；对比样与所述纺织基瓣叶的区别仅在于用高分子纱线替换增强纱线；The flexural stiffness of the radially reinforced textile base leaflet is 2.4 mN mm; the breaking strength is 106.82 MPa, and the elastic modulus is 49.75 MPa; It shows different degrees of improvement: the flexural stiffness is 1.20 times that of the control sample, the rapid elastic recovery angle is 72° larger than that of the control sample, the breaking strength is 1.29 times that of the control sample, and the elastic modulus is 2.39 times that of the control sample. The textile base leaflet differs only in that the reinforcing yarn is replaced with a polymer yarn;

径向增强的纺织基人工心脏瓣膜具有优异的血流动力学性能，经体外脉动流性能测试机检测，径向增强的纺织基人工心脏瓣膜的有效开口面积为2.56cm²，返流分数为13.78％，平均跨瓣压差为9.05mmHg，均满足GB 12279-2008国家标准和ISO 5840国际标准；径向增强的纺织基人工心脏瓣膜在舒张期快速关闭，在收缩期易打开，且不存在抖动、坍塌现象；径向增强的纺织基人工心脏瓣膜与对比样相比，血流动力学性能指标表现出不同程度的提高：有效开口面积(EOA)为对比样的1.29倍，平均跨瓣压差(MDP)为对比样的0.72倍；在收缩期可快速响应两侧压差的变化：同一时刻下的开口面积为对比样的1.00～1.42倍，各时刻的开口面积与对比样的倍数关系见表4；维持最大开口面积的时间为对比样的1.40倍；与对比样相比，有限元分析所得高分子材料部分的应力、应变数值表现出不同程度的降低：最大等效应力为对比样的0.43倍，最大等效应变为对比样的0.52倍。The radially reinforced textile-based prosthetic heart valve has excellent hemodynamic performance. The radially reinforced textile-based prosthetic heart valve has an effective opening area of 2.56 cm² and a regurgitation fraction of 13.78 as measured by an in vitro pulsatile flow performance tester. %, the average transvalvular pressure difference is 9.05mmHg, which both meet the national standard of GB 12279-2008 and the international standard of ISO 5840; the radially reinforced textile-based artificial heart valve closes rapidly in diastole, easy to open in systole, and there is no jitter Compared with the control sample, the radially reinforced textile-based artificial heart valve showed different degrees of improvement in the hemodynamic performance indicators: the effective opening area (EOA) was 1.29 times that of the control sample, and the average transvalvular pressure difference (MDP) is 0.72 times that of the control sample; it can quickly respond to changes in the pressure difference between the two sides during systole: the opening area at the same time is 1.00 to 1.42 times that of the control sample. Table 4; The time to maintain the maximum opening area is 1.40 times that of the control sample; compared with the control sample, the stress and strain values of the polymer material obtained by the finite element analysis show different degrees of reduction: the maximum equivalent stress is the control sample 0.43 times, the maximum equivalent effect becomes 0.52 times that of the control sample.

表1实施例1～8中的增强纱线及其编号Reinforcing yarns and their numbers in Table 1 Examples 1-8

表2实施例1～8中的高分子纱线及其编号Table 2 Polymer yarns and their numbers in Examples 1 to 8

表3实施例1～8中的纱线原料及其组织结构、参数Table 3 Yarn raw materials and their organizational structures and parameters in Examples 1 to 8

表4Table 4

Claims (8)

Translated fromChinese

1.一种径向增强的纺织基人工心脏瓣膜，包括纺织基瓣叶，其特征是：所述纺织基瓣叶的径向纱线中包括增强纱线和高分子纱线；1. a radially reinforced textile-based artificial heart valve, comprising a textile-based valve leaflet, characterized in that: the radial yarn of the textile-based valve leaflet includes a reinforcing yarn and a polymer yarn;所述纺织基瓣叶由所述径向纱线与周向纱线交织而成的；所述径向纱线指纺织基瓣叶径向上的纱线，所述周向纱线是指纺织基瓣叶周向上的纱线；The textile base leaflet is formed by interweaving the radial yarn and the circumferential yarn; the radial yarn refers to the yarn in the radial direction of the textile base leaflet, and the circumferential yarn refers to the textile base. Yarns in the circumferential direction of the leaflets;所述增强纱线为金属丝或者所述金属丝与高分子纤维构成的复合纱线；The reinforcing yarn is a metal wire or a composite yarn composed of the metal wire and the polymer fiber;所述增强纱线的根数占比为所述径向纱线总根数的1~50%；The number of the reinforcing yarns accounts for 1-50% of the total number of the radial yarns;所述径向增强的纺织基人工心脏瓣膜包括两个或三个所述纺织基瓣叶，在同一纺织基瓣叶中，所述增强纱线呈中心对称分布；The radially reinforced textile-based artificial heart valve comprises two or three of the textile-based valve leaflets, and in the same textile-based valve leaflet, the reinforcing yarns are centrally symmetrically distributed;所述纺织基瓣叶在平面状态下，径向纱线与瓣叶径向中心对称轴的夹角为0°、30°或45°；In the plane state of the textile base leaflet, the included angle between the radial yarn and the axis of symmetry of the radial center of the leaflet is 0°, 30° or 45°;所述纺织基瓣叶分为底部、腹部、接合区和自由边四个区域；所述增强纱线至少贯穿于腹部。The textile base leaflet is divided into four regions: the bottom, the abdomen, the joint area and the free edge; and the reinforcing yarn at least runs through the abdomen.2.根据权利要求1所述的一种径向增强的纺织基人工心脏瓣膜，其特征在于，所述径向纱线由所述增强纱线和高分子纱线组成。2 . The radially reinforced textile-based artificial heart valve according to claim 1 , wherein the radial yarns are composed of the reinforcing yarns and polymer yarns. 3 .3.根据权利要求1所述的一种径向增强的纺织基人工心脏瓣膜，其特征在于，所述周向纱线为高分子纱线。3 . The radially reinforced textile-based artificial heart valve according to claim 1 , wherein the circumferential yarn is a polymer yarn. 4 .4.根据权利要求1所述的一种径向增强的纺织基人工心脏瓣膜，其特征在于，所述金属丝为形状记忆合金丝。4 . The radially reinforced textile-based artificial heart valve according to claim 1 , wherein the metal wire is a shape memory alloy wire. 5 .5.根据权利要求1所述的一种径向增强的纺织基人工心脏瓣膜，其特征在于，所述增强纱线至少连续贯穿于底部和腹部。5 . The radially reinforced textile-based artificial heart valve according to claim 1 , wherein the reinforcing yarn at least continuously runs through the bottom and the abdomen. 6 .6.根据权利要求5所述的一种径向增强的纺织基人工心脏瓣膜，其特征在于，所述纺织基瓣叶由二向织物或平面三向织物构成；二向织物的组织结构包括平纹组织、斜纹组织、缎纹组织、平纹变化组织、斜纹变化组织、缎纹变化组织、重组织、双层组织及多层组织中的一种或几种；平面三向织物的组织结构包括平纹三向组织、斜纹三向组织和双平纹三向组织的一种或几种。6 . The radially reinforced textile-based artificial heart valve according to claim 5 , wherein the textile-based valve leaflet is composed of a bidirectional fabric or a planar tridirectional fabric; the tissue structure of the bidirectional fabric comprises plain weave. 7 . One or more of weave, twill weave, satin weave, plain weave, twill weave, satin weave, heavy weave, double-layer weave and multi-layer weave; One or more of three-way weave, twill weave and double-plain weave.7.根据权利要求1所述的一种径向增强的纺织基人工心脏瓣膜，其特征在于，织造所述纺织基瓣叶时，上机经密为150~2000根/10cm，上机纬密为150~2000根/10cm。7. a kind of radially reinforced textile-based artificial heart valve according to claim 1, is characterized in that, when weaving described textile-based valve leaflet, the upper machine warp density is 150～2000/10cm, and the upper machine weft density is 150～2000 pieces/10cm. 150~2000 pieces/10cm.8.根据权利要求1所述的一种径向增强的纺织基人工心脏瓣膜，其特征在于，所述纺织基瓣叶的厚度为0.05~0.3mm，所述增强纱线和所述高分子纱线的直径均小于0.2mm。8. The radially reinforced textile-based artificial heart valve according to claim 1, wherein the thickness of the textile-based valve leaflet is 0.05-0.3 mm, and the reinforcing yarn and the polymer yarn have a thickness of 0.05-0.3 mm. The diameters of the wires are all less than 0.2 mm.

Images