CN113274169B

CN113274169B - Radially-enhanced textile-based artificial heart valve

Info

Publication number: CN113274169B
Application number: CN202110537902.9A
Authority: CN
Inventors: 王璐; 陈诗萍; 魏岑; 秦思瑜; 林婧; 李超婧; 陶慧
Original assignee: Donghua University
Current assignee: Donghua University
Priority date: 2021-05-18
Filing date: 2021-05-18
Publication date: 2022-06-17
Anticipated expiration: 2041-05-18
Also published as: CN113274169A

Abstract

The invention relates to a radially-enhanced textile-based artificial heart valve, which comprises a textile-based valve leaflet, wherein radial yarns of the textile-based valve leaflet comprise enhancement yarns and high polymer yarns; the radial yarns refer to yarns in the radial direction of the textile base lobe; the reinforced yarn is a metal wire or a composite yarn formed by the metal wire and polymer fibers; the invention takes the polymer yarn and the metal wire as raw materials, improves the motion stability, the mechanical support property, the bending resilience and the fatigue resistance of the valve leaflet on the premise of ensuring that the valve leaflet is light and thin and has certain flexibility, and has more excellent mechanical property, hemodynamics property and durability compared with the valve which is not enhanced.

Description

Radially-enhanced textile-based artificial heart valve

Technical Field

The invention belongs to the technical field of medical instruments, and relates to a radially-enhanced textile-based artificial heart valve.

Background

In China, the incidence rate of valvular heart disease is 2.5-3.2%, about 400 million patients exist, more than 20 million patients needing valvular surgery every year account for the first adult heart surgery at present. When the heart valve is diseased to a certain extent, it cannot be repaired by surgery, mainly by artificial heart valve replacement, so as to restore or improve the valve function. At present, the artificial heart valves widely used clinically comprise mechanical valves and biological valves, but the mechanical valves are easy to generate thrombus, and patients need to take anticoagulant drugs for life; the biological valve is easy to be calcified and decayed, and has poor durability. The Transcatheter Aortic Valve Replacement (TAVR) which is clinically practiced for more than ten years has the characteristics of small risk, small trauma, quick operation, quick recovery of patients after operation and the like, provides more suitable selection for elderly and high-risk patients who are difficult to perform thoracotomy, and can benefit low-age and mild patients in the future. At present, the transcatheter artificial heart valve used clinically is mainly composed of a self-expanding/balloon-expanding metal stent and biological tissues (bovine pericardium, porcine aortic valve, etc.) similar to surgical valves, so that the transcatheter artificial heart valve not only has the defect that the biological tissues are easy to calcify, but also is easy to be damaged by compression and folding in the loading process, and is degraded before being used, so that the durability of the material is further reduced. In addition, to meet the requirements for transcatheter implantation, leaflet materials are generally required to be of small thickness to increase their foldability.

The current focus of research includes a new generation of prosthetic heart valves that utilize various polymeric materials to overcome the drawbacks of biological and mechanical valves and facilitate TAVR procedures. Common valve leaflet base material forms comprise a high molecular film and a micro-nano fiber base material, and the processing modes comprise a plastic forming technology, an electrostatic spinning technology, a 3D printing technology, a textile technology and the like. From the mechanism of opening and closing the heart valve, when the proper artificial heart valve makes differential pressure response to any side, the valve needs to be opened and closed easily, namely, when the valve is opened, the flow resistance borne by blood is extremely small, the blood can flow out smoothly, the valve can be closed immediately under smaller differential pressure, and the closed backflow is very small. Since the opening time is very short and the blood flow is in a high speed state, the thin and flexible leaflet is more advantageous for the increase of the orifice area and the smooth outflow of blood. Studies have shown that leaflets of extremely small thickness and excellent flexibility, while flexible in movement, tend not to open and close in a controlled manner. The diastolic valve leaf is easy to collapse and prolapse due to insufficient supporting force, so that adverse phenomena such as massive blood backflow and the like are caused, and the functionality of the valve is lost; in the opening and closing process, the valve blades can be transmitted from the bottom to the free edge to generate traveling waves, so that poor flapping motion (or shaking) is generated; the cyclic loading process tends to cause severe stress concentrations in mechanically deficient leaflets and eventually leads to the formation of holes and cracks, or induces calcification that affects the functionality and durability of the valve. On the other hand, the thick leaflet has high mechanical strength and good mechanical support, but is insensitive to opening and closing movements, has a small flap opening area, and is not smooth in blood outflow. Therefore, proper control of the thickness, structure, and mechanical properties of the leaflet material is critical to improving the hemodynamic performance and durability of the valve.

The textile-based artificial heart valve processed by the textile technology has a plurality of advantages, can accurately control the composition, thickness, structure and the like of a stent material to optimize the interventional process and realize the adjustment of the final geometric shape and biomechanical property of the product, and has wide application prospect in the fields of surgical valves, transcatheter valves, valved pipelines, tissue engineering valves and the like. Compared with a mechanical valve, the valve has good flexibility and biocompatibility; compared with biological valves, the biological valve is not easy to decay due to calcification, and raw materials are easier to obtain, so that the difference among batches is reduced, and batch production is realized; compared with a transcatheter valve taking biological tissues as valve leaflet materials, the valve has more excellent folding and compression resistance on the premise of smaller thickness and easy compression into a sheath, and can retain the original mechanical properties to a greater extent; compared with tissue engineering valves made of other materials, the tissue engineering valve can reasonably regulate and control the porosity and the pore size, is convenient for the planting and growth of cells, has high mechanical strength, can ensure the physiological stability after transplantation, and has unique advantages in the aspect of constructing fully-degradable and partially-degradable materials.

The leaflet materials of textile-based prosthetic heart valves of prior research are typically pure fabrics or fabric-reinforced polymer-based composites composed of flexible polymer yarns. However, the viscoelastic material has a hysteresis effect, and is difficult to respond to the pressure difference change quickly, and the fatigue resistance of the polymer material generally has certain limitations. The literature discloses a heart valve prosthesis which is prepared by taking superelastic shape memory nickel-titanium alloy wires as raw materials, adopting a weaving technology for forming and combining a tissue engineering technology. The pulsating flow test result shows that the effective opening area of the valve is 1.70-1.79 times of that of a commercial biological valve (bovine pericardium) of a control group, and the valve has excellent elasticity and compliance. Although the nickel-titanium alloy wire has good compliance, strong deformation recovery capability and good fatigue resistance, the pure metal valve leaflet has large overall mass and rigidity compared with a pure flexible polymer material, is not beneficial to the valve leaflet to keep the flexibility of movement in an opening and closing cycle and present a good joint form during diastole closing, and is not suitable for being implanted through a catheter, thereby limiting the application range of the valve leaflet; in addition, the interfacial bond strength between nitinol wires and polymers is also to be improved.

In view of the above, there is a need to develop a textile-based prosthetic heart valve that combines the advantages of polymer yarns and shape memory alloy wires.

Disclosure of Invention

The invention aims to solve the technical problem of providing a radial reinforced textile-based artificial heart valve, which is characterized in that a weaving technology is utilized to prepare a fabric in a textile-based valve leaflet, the radial direction and the circumferential direction of the valve leaflet both contain flexible high polymer yarns, so that good flexibility is provided, the valve is favorably implanted through a catheter and the valve can be flexibly opened and closed in a cardiac cycle; the metal wires are selectively woven in the radial direction of the valve leaflet (which means various centrosymmetric distribution modes and a penetrating interval), so that excellent mechanical strength, bending resilience and fatigue resistance are provided, and the hemodynamic performance and durability of the valve are improved, thereby having important clinical application value. Compared with the unreinforced textile-based artificial heart valve, the hemodynamics of the radially reinforced textile-based artificial heart valve is obviously improved, and important technical indexes such as effective opening area, reflux fraction, average trans-valve pressure difference and the like all meet the GB 12279 + 2008 national standard and the ISO 5840 international standard and are improved to different degrees; finite element analysis results show that the equivalent stress and equivalent strain values of the high polymer material part are reduced due to the weaving of the metal wires, the stress concentration phenomenon on the high polymer material is effectively relieved, and the method has important significance for improving the durability of the valve.

In order to achieve the purpose, the technical scheme of the invention is as follows:

a radially-reinforced textile-based prosthetic heart valve comprises a textile-based valve leaflet, wherein radial yarns of the textile-based valve leaflet comprise reinforcing yarns and high polymer yarns.

The radial yarns refer to yarns in the radial direction of the textile base lobe;

the reinforced yarn is a metal wire or a composite yarn formed by the metal wire and polymer fibers.

As a preferred technical scheme:

a radially reinforced textile-based prosthetic heart valve as described above, said radial yarns consisting of said reinforcing yarns and polymeric yarns; the number of the reinforcing yarns accounts for 1-50% (preferably 10-30%) of the total number of the radial yarns; the number of the reinforcing yarns is too small, so that the reinforcing yarns have no obvious effect on the enhancement of the hemodynamic performance and durability of the valve; too many, which results in too large mass and poor flexibility of the valve leaflet, is not favorable for flexible opening and closing and quick response to pressure difference change.

A radially-reinforced textile-based prosthetic heart valve as described above, comprising two or three of said textile-based leaflets, said reinforcing yarns being distributed centrally-symmetrically within the same textile-based leaflet.

The arrangement mode is one of the following:

the first arrangement is uniform distribution, i.e. the reinforcing yarns are uniformly distributed in the radial yarns;

the second arrangement is that the cells are uniformly distributed, i.e. the cells are uniformly distributed in the radial yarns; the unit consists of a plurality of adjacent reinforcing yarns or a plurality of adjacent reinforcing yarns and a few polymer yarns spaced among the adjacent reinforcing yarns; the number of the plurality of the reinforcing yarns is more than 50% of the total number of the yarns in the unit; the total number of the yarns in the unit is 3-20% of the total number of the radial yarns; the minority means that the number of the high molecular yarns does not exceed 50% of the sum of the numbers of the reinforcing yarns in the unit;

the third mode of arrangement is that the units are symmetrically distributed, namely the units change from the middle to two sides according to a certain rule; the change according to a certain rule is that: the width of the units, the space between the units or the number of the reinforcing yarns in the units, the diameter of the reinforcing yarns in the units are monotonically increased or monotonically decreased, or the types of the reinforcing yarns in the units are changed; the reinforcing yarn includes a metal wire or a polymer fiber contained therein.

For example: (1) the width of each unit is the same, the interval between the units is not changed, but the number (or thickness or type) of the reinforcing yarns is changed; (2) the individual cells are identical, but the spacing between the cells varies; (3) the pitch between the cells is the same, the thickness or kind of the reinforcing yarn is the same, but the number of reinforcing yarns or the width of the cells is changed.

A radially reinforced textile-based prosthetic heart valve as described above, the textile-based leaflet being formed by the radial yarns interwoven with circumferential yarns; the circumferential yarns are yarns in the circumferential direction of the textile base valve leaflet, and the circumferential yarns are high molecular yarns.

The polymer yarn is monofilament, multifilament, core-spun yarn, covered yarn, braided yarn, nano electrostatic spun yarn or filament/nanofiber covered yarn;

the raw material of the high polymer yarn is one or the combination of a non-degradable material and a degradable material;

the non-degradable material is one or more of polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polytrimethylene terephthalate (PTT), Polytetrafluoroethylene (PTFE), Polyamide (PA), polypropylene (PP), Polyethylene (PE), Polyurethane (PU), ultrahigh molecular weight polyethylene (UHMWPE) and real silk;

the degradable material is one or more of Polycaprolactone (PCL), polylactic acid (PLA), levorotatory polylactic acid (PLLA), Polyglycolide (PGA), polylactic acid-glycolic acid copolymer (PLGA), polydioxanone (PPDO), polytrimethylene sebacate (PGS), Polyglycolide (PGLA), silk fibroin, collagen, hyaluronic acid and gelatin.

The fabric in the textile base lobe may be non-degradable or partially degradable;

the non-degradable fabric comprises reinforcing yarns and non-degradable high molecular yarns;

the partially degradable fabric must contain reinforcing yarns and degradable polymeric yarns, and not necessarily non-degradable polymeric yarns.

In the valve capable of being partially degraded, the degradable part is replaced by the new tissue, and the non-degradable part can be used as a permanent mechanical support, so that the reliability is higher.

A radially reinforced textile-based prosthetic heart valve as described above, said metal wire being a shape memory alloy wire. The shape memory alloy wire comprises a copper-based shape memory alloy wire and a nickel titanium-based shape memory alloy wire (preferably, the nickel titanium-based shape memory alloy wire is hereinafter referred to as the nickel titanium alloy wire); the shape memory alloy wire has super elasticity (or called pseudo elasticity), the sample can generate strain which is far larger than the elastic limit strain amount of the sample under the action of the external force, and the strain can be automatically recovered when the sample is unloaded; the nickel-titanium alloy wire has a stretch rate of more than 20 percent and a fatigue life of 1 multiplied by 10⁷The damping characteristic is 10 times higher than that of the common spring, and the corrosion resistance of the spring is superior to that of the best medical stainless steel at present.

A radially-reinforced textile-based prosthetic heart valve as described above, said textile-based leaflets being divided into four regions, a base, a belly, a commissure region, and a free edge; the reinforcing yarns extend at least through the abdomen.

A radially reinforced textile-based prosthetic heart valve as described above, said reinforcing yarns extending continuously at least through the fundus and the abdomen.

On the premise of weaving a light and thin (0.05-0.3 mm) fabric, the reinforcing yarns have four functions:

(1) the excellent motion stability of the valve blades in the opening and closing process is ensured, the good motion form is kept, and the flapping/shaking phenomenon is avoided;

(2) the mechanical support of the valve leaf is increased, so that the valve leaf has good mechanical property and can keep a tight joint state in diastole, and the valve leaf is prevented from being broken and prolapsed under higher aortic pressure;

(3) the composite load under the stretching, bending and shearing actions in the process of cyclically opening and closing the valve leaflets is assisted to bear, and the durability of the valve leaflets is improved;

(4) under the prerequisite of guaranteeing that leaflet bending stiffness is less, easily closing under reverse blood pressure effect, increase the bending resilience of leaflet for the leaflet has the trend of initiatively reverting to the open mode by the closed condition in the shrink phase, can the change of quick response pressure differential, open rapidly and the valve opening area is big, thereby makes the blood flow out fast, smoothly.

In achieving this, the reinforcing yarns may be present only in the leaflets, or in the leaflets and the fabric used as an attachment that is co-woven with the leaflets. The appendage and leaflet demarcate a leaflet base. When the reinforcing yarn is present only in the lobes, the above-described effects (1) to (3) are provided; the reinforcing yarn is continuously present in the leaflet and its attachments, and then functions (1) to (4) described above are provided. This can be done when the reinforcing yarn is continuously passed through the bottom and abdomen of the appendage and the leaflet (1) - (4). This can be achieved when the reinforcing yarn penetrates the web of the leaflet but does not penetrate the base of the leaflet, as described above in relation to (1) to (3).

The radially-reinforced textile-based artificial heart valve comprises the textile-based valve leaflet, wherein in a planar state, the included angle between the radial yarn and the radial central symmetry axis of the valve leaflet is 0 degree, 30 degrees or 45 degrees.

The tissue structure has a certain relationship with the matching of the included angles.

(1) The included angle of 0 degree corresponds to a conventional plane or tubular woven fabric, and the direction of the metal wire is parallel to the radial central line of the valve leaf; errors within 3 ° exist in valve molding;

(2) the 45-degree included angle corresponds to the conventional plane woven fabric, and the direction of the metal wire forms a 45-degree included angle with the radial center line of the valve leaflet; errors within 3 degrees exist during valve molding;

(3) the 30 degree included angle corresponds to a plane three-way fabric, the direction of the metal wire and the radial central line of the valve leaflet form the 30 degree included angle, and an error within 3 degrees exists during valve molding.

When the included angle of the metal wire and the radial central line is within the range of 0-45 degrees, the improvement of the bending resilience of the valve leaflet and the stability (avoiding the shaking/flapping phenomenon) of maintaining the opening and closing movement have obvious effects.

A radially-reinforced textile-based prosthetic heart valve as described above, said textile-based leaflet being constructed of bi-directional fabric or planar tri-directional fabric; the weave structure of the bidirectional fabric comprises one or more of plain weave, twill weave, satin weave, plain weave change, twill change, satin change, heavy weave, double-layer weave and multi-layer weave; the weave structure of the plane three-way fabric comprises one or more of plain three-way weave, twill three-way weave and double plain three-way weave.

When the textile-based artificial heart valve is woven, the upper warp density is 150-2000 pieces/10 cm, and the upper weft density is 150-2000 pieces/10 cm. When the fabric tightness is high, the water permeability of the fabric is low, coating treatment is not needed, and the fabric is generally used as a permanent replacement valve; when the tightness of the fabric is not high, the water permeability of the fabric is high, and coating treatment is needed to reduce leakage, so that the fabric can be used as a valve for permanent replacement and a tissue engineering valve with regeneration capacity.

According to the 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 yarns and the polymer yarns are smaller than 0.2 mm. Compared with the textile base valve leaflet without radial reinforcement, the textile base valve leaflet provided by the invention has similar thickness and slightly larger bending rigidity, but the mechanical strength, modulus, bending resilience and fatigue resistance are obviously improved, and the improvement on the hemodynamic performance and durability of the subsequently manufactured artificial heart valve is positively influenced.

The composite yarn can be divided into woven yarn, plied yarn and covered yarn according to yarn types; the polymer fibers in the composite yarn can be divided into filaments and short fibers according to the geometric length; the composite yarn has the advantages that the friction force between the metal wires in the composite yarn and the adjacent or crossed high polymer yarns can be obviously increased, so that certain weavability is ensured, and the structural stability is improved.

The length of the free edge of the textile base valve leaf is more than 5% larger than the diameter of the valve, and the textile base valve leaf has the minimum length required by closing the valve; the free edge is curved (including straight or curved) in shape, wherein the curved shape provides sufficient material to seal against fluid reversal at the center with a minimum area of coaptation as compared to a straight line to minimize damage to red blood cells in the blood between the contact surfaces and to prevent the cusps from sticking and obstructing the opening of the leaflets; the free edge has a stabilizing structure and is smooth and flat; the fabric used as the free edge has five forming modes:

(1) selvage in the weaving process is adopted.

If the radial direction of the valve leaf corresponds to the weft direction of the fabric and the circumferential direction of the valve leaf corresponds to the warp direction of the fabric, the free edge is the conventional warp selvage. On one hand, the problem of separation possibly caused by cutting is avoided, the stability of the fabric structure is kept, the operation is simplified, on the other hand, the characteristic of the cloth edge enables the free edge to bear smaller bending deformation in the repeated loading process of the valve leaflet, and the valve has good fatigue resistance. The significance of the warp-wise cloth edge in the weaving process is that the warp-wise cloth edge bears the action of various external forces and protects the edge of the fabric from being damaged; the characteristics of the selvedge are as follows: the strength is high, the cloth is straight and smooth, the thickness is consistent with or close to that of the cloth body, and the tightness is consistent with or slightly tight to that of the cloth body;

if the valve leaf corresponds to the fabric warp direction in the radial direction and the valve leaf corresponds to the fabric weft direction in the circumferential direction, the free edge is a special weft-direction selvage. The shedding phenomenon (recorded in the prior art) possibly caused by cutting is avoided, and the stability of the fabric structure is favorably maintained.

(2) Formed using laser cutting or ultrasonic cutting.

(3) Bonding the coating layer by mechanical cutting, laser cutting or ultrasonic cutting;

(4) before weaving, a plurality of yarns with lower melting points than thermoplastic polymer yarns, such as low-melting spandex and degradable yarns with low melting points and long degradation period, are arranged near the cutting part of the free edge, so that the free edge can be subjected to melt edge sealing while the thermoplastic polymer yarns are subjected to heat setting after being taken off the machine; the purpose of the heat setting is to improve the structural stability of the fabric.

(5) After weaving, when cutting the free edge, keeping a section of fabric without metal wires, wherein, one end connected with the fabric used as the valve leaflet is used as the free edge of the valve leaflet, folding the free edge in half along the radial direction, and sewing the free end of the free edge to the fabric used as the valve leaflet or the valve leaflet main body by using a sewing line; the fabric without metal wires is 1.5-4 mm long in the radial direction.

The radially reinforced textile-based prosthetic heart valve comprises, in addition to textile-based leaflets, a skirt, stent, or vascular prosthesis attached to the textile-based leaflets with sutures;

a radially reinforced textile-based prosthetic heart valve as described above, manufactured in the following manner:

the method comprises the following steps: the sheet fabric is cut into two or three independent or connected semilunar valve leaflets, and then the semilunar valve leaflets are combined with the skirt to be sewn on the stent or sewn in the artificial blood vessel.

The method 2 comprises the following steps: the sheet fabric is heat set into two or three curved shapes with the leaflets in a "zero pressure" condition (just as the leaflets engage each other) and then sewn in conjunction with the skirt onto the stent or into the vascular prosthesis.

The method 3 comprises the following steps: two sides of the sheet-shaped fabric are sewn together to form a tubular fabric, and the tubular fabric and a Single Point Attached Composites (SPAC) sewing mode are utilized to be sewn on the stent in combination with the skirt edge or sewn in the artificial blood vessel.

The method 4 comprises the following steps: constructing a seamless tubular fabric by a weaving technique; the skirt is sewn on the stent or sewn in the artificial blood vessel by using a tubular fabric and Single Point Attached (SPAC) sewing mode.

The method 5 comprises the following steps: the curved surface shape of the three flaps just jointed is obtained by utilizing tubular fabric, combining a mould and a heat setting process, and then the three flaps are combined with a skirt edge to be sewed on the bracket or to be sewed in an artificial blood vessel.

The method 6 comprises the following steps: two sides of the sheet-shaped fabric are sewn together to form a tubular fabric, the tubular fabric is folded inwards or outwards to form an inner layer tube and an outer layer tube, the inner layer tube and the outer layer tube are sewn together along the axial direction to form two or three longitudinal sewing connecting lines, and therefore the inner layer is limited into two or three valve leaf shapes which are rectangular under the state that the two layers are attached and are bag-shaped under the separated state. Wherein one side of the inner tube as a free edge is not connected with the outer layer. Finally, the outer layer tube is sewed on the stent or the artificial blood vessel;

the method 7 comprises the following steps: sewing two sides of the sheet fabric to form a tubular fabric, folding the tubular fabric inwards or outwards to form an inner layer tube and an outer layer tube, and sewing two or three connected and complete valve leaflet bottom curves to better define the geometric shape of the valve leaflets; wherein one side of the inner tube as a free edge is not connected with the outer layer. Finally, the outer layer tube is sewed on the stent or the artificial blood vessel;

the method 8 comprises the following steps: in another embodiment, the mode of sewing connection in 6 can be changed into connection by interweaving warp and weft in the weaving process, and the connection strength is similar to the strength of the fabric. That is, in a double-width fabric or a multilayer tubular fabric, a straight seamless connecting line is formed by binding warp and weft yarns up and down.

The reinforcing yarns play a positive role in the mechanical performance of valve leaflets and the hemodynamic performance and durability of valves, and the test results of various performances are as follows:

1. mechanical properties of the leaflets

The radially-reinforced textile-based artificial heart valve has the advantages that the bending rigidity of the radially-reinforced textile-based valve leaflet is 0.8-2.5 mN.mm; the breaking strength is 5-577 MPa, and the elastic modulus is 5-1286 MPa; the radially reinforced textile base leaflet exhibits different degrees of improvement in radial mechanical properties compared to the control: the bending rigidity is 1.06-1.23 times of that of the comparison sample, the acute elastic recovery angle is 10-80 degrees larger than that of the comparison sample, the breaking strength is 1.10-1.37 times of that of the comparison sample, and the elastic modulus is 1.19-2.51 times of that of the comparison sample; the control sample only differs from the textile base leaflet by replacing the reinforcing yarn with the polymeric yarn.

Therefore, the bending performance result shows that the bending rigidity of the valve leaflet is not obviously increased and is kept in a small range, which indicates that the flexibility of the valve leaflet is not greatly influenced by the weaving of the reinforcing yarns, so that the valve leaflet can be easily closed under the aortic pressure in the diastole and has no large influence on the flow return; the acute elastic recovery angle is obviously increased, which shows that the bending resilience of the valve leaf is obviously increased, the valve can quickly respond to the change of the pressure difference at two sides in the contraction period, and is quickly opened and has a large opening area, so that blood can quickly and smoothly flow out, and the effective opening area in the hemodynamic parameters is increased and the average cross-valve pressure difference is reduced; the tensile property result shows that the fracture strength of the valve leaf is increased to a certain extent, the elastic modulus is obviously increased, the mechanical support property of the valve leaf is favorably enhanced, the valve leaf can bear high blood pressure in diastole, and the adverse phenomena of cracking, prolapsing, collapse and the like do not occur; in addition, the obvious increase of the elastic modulus has positive influence on improving the stability of the valve blades in opening and closing movement, and the shaking/beating phenomenon can be avoided when the thickness is very small.

2. Hemodynamic performance of valves

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 1.5-2.8 cm through detection of an in-vitro pulsating flow performance tester²The reflux fraction is less than 15 percent, the average trans-petal pressure difference is less than 10mmHg, and the national standard GB 12279-; compared with a comparison sample, the hemodynamic performance indexes of the radially-enhanced textile-based artificial heart valve are improved to different degrees: the Effective Opening Area (EOA) is 1.05-1.36 times of that of the comparison sample, and the average cross-petal pressure difference (MDP) is 0.68-1.00 times of that of the comparison sample; the change of the pressure difference between two sides can be quickly responded in the contraction period: the opening area at the same time is 1.00-1.42 times of that of the comparison sample, and the time for maintaining the maximum opening area is 1.10-1.50 times of that of the comparison sample.

3. Durability of valve

In a radially reinforced textile-based prosthetic heart valve as described above, the stress and strain values of the polymer material portion obtained by finite element analysis show different reductions compared to the control sample: the maximum equivalent stress is 0.39-0.87 times of the comparison sample, and the maximum equivalent strain is 0.46-0.85 times of the comparison sample.

The fatigue strength of the nickel-titanium alloy wire is more than 558MPa (the cycle period is more than 10)⁷) Compared with common medical polymer materials, the high-polymer material has extremely excellent fatigue strength, so that the introduction of the reinforcing yarns effectively relieves the stress concentration phenomenon on the polymer materials, and has important influence on the improvement of the valve durability.

The mechanism of the invention is as follows:

the main body fabric in the textile basic lobe is prepared by a weaving technology, and takes high molecular yarns and metal wires as raw materials. In particular, most of the yarns are polymeric yarns, which give the leaflet material a very 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.

Compared with the non-reinforced valve leaflet, a small amount of reinforcing yarns are selectively woven in the radial direction of the valve leaflet, and the characteristics of super elasticity, high strength, high modulus, high fatigue resistance, high flexibility and the like of the valve leaflet play positive roles in the mechanical properties of the valve leaflet and the hemodynamic properties and the fatigue resistance of the valve leaflet:

(1) the high modulus of the metal wire is utilized to increase the elastic modulus after radial reinforcement, so that excellent motion stability of the valve leaflet in the opening and closing process is ensured, a good motion form is kept, and the fluctuation/flapping phenomenon is avoided;

(2) the high strength and high modulus of the metal wire are utilized to increase the fracture strength and elastic modulus after radial reinforcement, thereby improving the mechanical support of the valve leaflet and avoiding the undesirable phenomena of rupture, prolapse or collapse and the like under the aortic pressure with higher diastole;

(3) the high fatigue resistance of the metal wire is utilized to assist in bearing the composite load of the polymer material part in the valve leaflet under the stretching, bending and shearing actions in the cyclic opening and closing process, so that the stress and strain are reduced, and the durability of the valve leaflet is improved;

(4) by utilizing the high flexibility and the super elasticity of the metal wire, the bending rigidity of the valve leaflet is kept in a small numerical range, and on the premise of being easy to close under the action of reverse blood flow pressure, the crease recovery angle of the valve leaflet is increased, so that the bending resilience of the valve leaflet is increased, the valve leaflet has the tendency of actively recovering from a closing state to an opening state in the early contraction period, the change of differential pressure is quickly responded, the effective opening area at the same moment is larger, the time for reaching the maximum opening area is shorter, and blood flow flows out quickly and smoothly.

On the other hand, different penetration intervals of the wire will give the leaflet different mechanical and hemodynamic properties. (1) The above-mentioned

actions

1, 2, 3 can be provided when the wire is present only in the leaflet, in which case the different penetration intervals of the wire in the leaflet will produce different effects: firstly, when the metal wire only penetrates through the bottom and the abdomen of the valve leaflet, the joint area and the free edge are formed by interweaving high molecular yarns, the valve leaflet is flexible and light in weight, the closing speed of the valve leaflet is higher in diastole, the valve leaflet is more tightly jointed, and the flow returning quantity is less; when the metal wire penetrates from the bottom of the valve leaflet to the free edge, the metal wire can assist in bearing the load of the joint area and the free edge, and the durability of the valve leaflet is improved; (2) the

functions

1, 2, 3, 4 may be provided when the wire is continuously present in the leaflet and its appendages.

Advantageous effects

(1) The invention relates to a radially-reinforced textile-based artificial heart valve, which takes non-degradable metal wires and non-degradable or degradable high molecular yarns as raw materials, wherein non-degradable valve leaflets are used as permanent artificial heart valves, and partially degradable valve leaflets are used as tissue engineering heart valves; on the other hand, the textile base valve leaflet is connected with a surgical valve, a stent of an interventional valve or an artificial blood vessel with a valve duct, and the application range can be further widened;

(2) the invention takes the macromolecule yarn and the metal wire as raw materials, and improves the motion stability, the mechanical support property, the bending resilience and the fatigue resistance of the valve leaflet on the premise of ensuring that the valve leaflet is light and thin and has certain flexibility, thereby leading the valve to have better mechanical property, hemodynamics property and durability.

Drawings

FIG. 1 is a schematic view of the overall construction of a radially reinforced textile-based prosthetic heart valve of the present invention;

FIG. 2 is a schematic representation of the connection of regions of a radially reinforced textile-based prosthetic heart valve of the present invention;

figure 3 is a schematic view of a distribution a of reinforcing yarns on the leaflet of the present invention;

figure 4 is a schematic view of the distribution B of reinforcing yarns on the leaflet of the present invention;

figure 5 is a schematic view of the distribution E of reinforcing yarns on the leaflet of the present invention;

fig. 6 is a structural view illustrating a penetration pattern I of reinforcing yarns on the leaflet of the present invention;

fig. 7 is a structural view illustrating a penetration pattern II of reinforcing yarns on the leaflet of the present invention;

fig. 8 is a schematic view of the positional relationship W1 of the radial yarns on the leaflet and the radial center axis of the leaflet of the present invention;

FIG. 9 is a schematic view of the relationship W2 between the radial yarn on the leaflet and the radial center axis of the leaflet of the present invention

Fig. 10 is a schematic view of the positional relationship W3 of the radial yarns on the leaflet and the radial center axis of the leaflet of the present invention;

fig. 11 is a schematic view of the relationship W4 between the radial yarn on the leaflet and the radial center axis of the leaflet of the present invention;

fig. 12 is a schematic view of the positional relationship W5 of the radial yarns on the leaflet and the radial center axis of the leaflet of the present invention;

fig. 13 is a schematic view of the positional relationship W6 of the radial yarns on the leaflet and the radial center axis of the leaflet of the present invention;

fig. 14 is a schematic view of the relationship W7 between the radial yarn on the leaflet and the radial center axis of the leaflet of the present invention;

fig. 15 is a schematic view of the relationship W8 between the radial yarn on the leaflet and the radial center axis of the leaflet of the present invention;

FIG. 16 is a schematic view showing the structure of the assembled heart valve prosthesis of example 1;

fig. 17 is a top view of the three leaflets of example 1 in a closed position;

fig. 18 is an oblique view of the three leaflets of example 1 in a closed state;

FIG. 19 is an SEM image of the fabric of example 1 at 50 times magnification; wherein, the inside of the black dotted line frame is reinforced yarn;

FIG. 20 is a graph of the fluid mechanics of a radially reinforced textile-based prosthetic heart valve of the present invention;

wherein, 1-joint, 2-free edge, 3-joint zone, 4-belly, 5-bottom, 6-high molecular yarn, 7-yarn gap, 8-reinforced yarn, 9-unit, 10-valve leaf, 11-skirt and 12-support.

Detailed Description

The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Further, it should be understood that various changes or modifications of the present invention may be made by those skilled in the art after reading the teaching of the present invention, and such equivalents may fall within the scope of the present invention as defined in the appended claims.

The test method adopted in the invention is as follows:

(1) tensile Property test of leaflets

Prosthetic heart valves according to GB 12279 & 2008 cardiovascular implant and ISO 5840-1:2015 cardiovascular implant heart valve prosthesis. part 1: general requirements, the breaking strength and elastic modulus of key mechanical property indexes in the artificial heart valve need to meet certain conditions, so the radial direction of the valve leaflet material is tested on a YG (B)026G type electronic fabric strength instrument. Randomly selecting 5 areas, shearing a sample with the thickness of 5mm multiplied by 20mm in each area, setting the stretching speed to be 50mm/min and the pre-tension to be 0.1N, stretching the sample until the sample is broken, calculating the breaking strength and the elastic modulus according to test data, and averaging the results.

(2) Bending Performance test of valve leaflets

The radial bending rigidity of the valve leaflet is measured by using a cantilever bending tester (ASTM D1388-07A), and the radial bending deformation capacity of the valve leaflet is quantitatively characterized. Rectangular samples (10mm for leaflet circumference and 75mm for leaflet radius) were selected with dimensions of 10 x 75mm, each sample placed on a smooth, low friction horizontal platform at one end and an adjustable bend angle pointer 41.5 "(0.724 rad) below the other end. The weighted slide was placed on the sample and advanced at a constant rateAnd then. When the leading edge of the sample protrudes from the platform, it will bend under its own mass. Once the material has bent to a sufficient extent to contact the bend angle indicator, the test is stopped. Measuring the length of the bend and according to B_exp＝W·C³Calculating the flexural modulus, where W is the fabric weight (N/mm)²) C is the bending length (mm), B_expBending stiffness obtained experimentally.

(3) Wrinkle elasticity test of valve leaflets

The radial direction of the leaflet material was tested using a YG541L model digital fabric wrinkle elasticity meter according to GB/T3819 and 1997 method for measuring the recovery angle of the crease of textile fabric. 5 samples of each fabric were selected and tested, and the fabric was cut into a 40mm × 15mm triangular shape with a pressure load of 10cN and a pressing time of 5 min. In order to prevent the adhesion phenomenon of the test sample in the test process from influencing the measurement result, 1 piece of paper or plastic film with the thickness of less than 0.02mm is placed between the two wings at the position 2mm away from the crease line.

(4) Hydrodynamic testing of prosthetic heart valves

According to GB 12279 + 2008 < cardiovascular implant prosthetic heart valve > and ISO 5840-1:2015 < cardiovascular implant. General requirements, the prepared artificial heart valve is subjected to hemodynamic performance detection by using an MPD-1000 type modular artificial heart valve pulsatile flow performance testing machine of shanghai heart valve testing equipment ltd. The test temperature was 37 ℃ and the fluid used was normal saline. The heart rate was set at 70beat/min, the simulated cardiac output at 5L/min, the mean aortic pressure at 100mmHg (ensuring aortic systolic pressure at 120mmHg and diastolic pressure at 80mmHg), and the systolic (ante-pulsatile flow) percentage at 35%. And detecting a simulation period within 10min, and calculating pulsating flow characteristic parameters of the biological valve under the parameter conditions by using test software, wherein the pulsating flow characteristic parameters comprise effective opening area, reflux percentage, average trans-valve pressure difference and the like. The test procedure was recorded by a high speed camera and the area of the opening at a certain time during the contraction period was calculated using IamgeJ image processing software. The starting point of the contraction period is 0cs, the valve opening area under the 3.6cs (early contraction), 20.1cs (peak contraction) and 32.5cs (end contraction) is calculated, and the time for basically maintaining the maximum opening area is used for showing the effect of rapid response differential pressure of the valve leaf after radial reinforcement.

In the embodiment of the invention, in the same textile basic lobe, the reinforcing yarns are distributed in a central symmetry mode, and the specific distribution mode can be as follows:

distribution A: even distribution, i.e. the reinforcing yarns 8 are evenly distributed in the radial yarns (as shown in fig. 3), wherein the enlarged view is the distribution of the polymer yarns 6, and the yarn gaps 7 are between the polymer yarns 6;

distribution B: the cells are uniformly distributed, i.e. the cells 9 are uniformly distributed in the radial yarns; the unit is composed of a plurality of adjacent reinforcing yarns 8; the number of the plurality of finger reinforced yarns accounts for more than 50% of the total number of the yarns in the unit; the total number of the yarns in the unit is 3-20% of the total number of the radial yarns; the minority indicates that the number of the high molecular yarns 6 is not more than 50 percent of the sum of the numbers of the reinforcing yarns 8 in the unit (shown in figure 4);

distribution C: the cells are uniformly distributed, i.e. the cells are uniformly distributed in the radial yarns; the unit consists of a plurality of adjacent reinforced yarns and a few high molecular yarns spaced among the adjacent reinforced yarns; the number of the plurality of finger reinforced yarns accounts for more than 50% of the total number of the yarns in the unit; the total number of the yarns in the unit is 3-20% of the total number of the radial yarns; the number of the minority-mean high molecular yarns is not more than 50% of the total number of the reinforcing yarns in the unit;

distribution D: the units are symmetrically distributed, namely the units change from the middle to two sides according to a certain rule; the change according to a certain rule is that: the width of the unit, the space between the units, the number of the reinforcing yarns in the unit and the diameter of the reinforcing yarns in the unit are monotonically increased or monotonically decreased.

Distribution E: the units are symmetrically distributed, namely the units 9 are changed from the middle to the two sides according to a certain rule; the change according to a certain rule is that: the number of said reinforcing yarns 8 in the unit varies according to a certain law (as shown in figure 5); the kind of the reinforcing yarn includes the kind of the metal wire or the polymer fiber contained therein.

In the embodiment of the invention, the textile base valve leaflet has an included angle of 0 °, 30 ° or 45 ° between the radial yarn and the radial central symmetry axis (i.e. the radial central line in the figure) of the valve leaflet in a plane state, specifically:

positional relationship W1: when the included angle is 0 degree, the woven fabric belongs to a conventional woven fabric structure, and the interweaving angle of the warp yarns and the weft yarns is 90 degrees, as shown in figure 8;

positional relationship W2: when the included angle is 0 degrees, on the basis of the position relation W1, the warp and weft yarns are reversed in sequence (as shown in figure 9);

positional relationship W3: when the included angle is 45 degrees, the fabric belongs to a conventional woven fabric structure, and the interweaving angle of the warp yarns and the weft yarns is 90 degrees, as shown in figure 10;

positional relationship W4: when the included angle is 45 degrees, on the basis of the position relation W3, the warp and weft yarns are reversed in sequence (as shown in figure 11);

positional relationship W5: when the included angle is 30 degrees, the fabric belongs to a planar three-dimensional fabric structure, two systems of warp yarns (both radial yarns) + one system of weft yarns (as shown in figure 12) are adopted, and the angle of intersection of the yarns is 60 degrees;

positional relationship W6: when the included angle is 30 degrees, a planar three-dimensional fabric structure is adopted, two systems of warp yarns + one system of weft yarns (as shown in fig. 13) are adopted, the angle of mutual intersection of the yarns is 60 degrees, and the warp yarns of the one system and the weft yarns of the one system are radial yarns.

Positional relationship W7: when the included angle is 30 degrees, the fabric belongs to a plane three-way fabric structure, one system of warp yarns and two systems of weft yarns (as shown in figure 14) are adopted, and one system of warp yarns and one system of weft yarns are radial yarns;

positional relationship W8: when the included angle is 30 degrees, the fabric belongs to a plane three-way fabric structure, and one system of warp yarns and two systems of weft yarns (both radial yarns) are adopted (as shown in figure 15);

in the embodiment of the invention, the reinforcing yarn has 6 penetration modes on the valve leaflet, specifically:

the penetration mode I: continuously throughout the bottom (length a) + belly (length b), as shown in fig. 6;

through mode II: continuously throughout the bottom (length a) + belly (length b) + land (length c);

mode III for the present invention: continuously through the bottom (length a) + belly (length b) + landing zone (length c) + free edge (length d) as shown in fig. 7;

a penetration mode IV: continuously penetrates the abdomen (length b) + the junction (length c) + the free edge (length d);

a penetration mode V: continuously throughout the abdomen (length b) + landing zone (length c);

mode VI: continuously throughout the abdomen (length b);

wherein a, b, c, d represent the length of the bottom 5, web 4, land 3 and free edge 2, respectively, in the radial direction.

Example 1

A radial reinforced textile-based artificial heart valve is used as a transcatheter artificial heart valve, as shown in figures 16-18, the diameter of the artificial heart valve is 21mm, and the manufacturing method is method 5, the radial reinforced textile-based artificial heart valve comprises a self-expanding nickel-titanium alloy bracket 13, three textile-based valve leaflets 10 and a skirt 11 inside the bracket, and the three parts are connected together through sewing points (three points which are sewn at the far end and evenly distributed on the circumference form a connecting part 1 between the valve leaflets), so that the structural stability and the opening and closing functions of the valve are realized; as shown in fig. 1-2, the textile base leaflet is divided into four areas, namely a bottom area, an abdomen area, a joint area and a free edge, and is made of a fabric formed by interweaving radial yarns in the radial direction of the textile base leaflet and circumferential yarns in the circumferential direction of the textile base leaflet (the tissue structure is shown in table 3); the radial yarns consisted of reinforcing yarns (see tables 1 and 3) and polymeric yarns (see tables 2 and 3); when weaving, the warp density of the upper machine is 600 pieces/10 cm, and the weft density of the upper machine is 500 pieces/10 cm; in addition, when the textile base valve leaf is in a plane state, the included angle between the radial yarn and the radial central symmetry axis of the valve leaf is 0 degree (the position relation is W1), and the number of the reinforcing yarn accounts for 10 percent of the total number of the radial yarn; in the same textile basic lobe, the reinforced yarns are distributed in a centrosymmetric manner in a uniform distribution mode A; the penetrating mode of the reinforcing yarns on the valve leaflets is a penetrating mode III; fig. 17 and 18 are a top view and an oblique view of three leaflets, respectively, in a closed state.

The free edge of the textile base valve leaf is arc-shaped; the thickness of the textile base valve leaf is 0.12 mm;

the bending rigidity of the radially reinforced textile base valve leaflet is 1.2 mN.mm; the breaking strength is 41.81MPa, and the elastic modulus is 568.10 MPa; the radial mechanical properties of the radially reinforced textile base leaflet showed different improvements compared to the control: the bending rigidity is 1.09 times of that of a comparison sample, the acute elastic recovery angle is 30 degrees larger than that of the comparison sample, the breaking strength is 1.15 times of that of the comparison sample, and the elastic modulus is 1.59 times of that of the comparison sample; the control only differs from the textile base leaflet by replacing the reinforcing yarns with polymeric yarns. The bending performance result shows that the bending rigidity of the valve leaf is almost unchanged and has small value, which shows that the flexibility of the valve leaf is not greatly influenced by the weaving of the reinforced yarn, and the valve leaf can be easily closed under the aortic pressure in diastole; the sharp elastic recovery angle is obviously increased, which shows that the bending resilience of the valve leaf is obviously increased, the valve can quickly respond to the change of pressure difference at two sides in the contraction period, and the valve can be quickly opened and has large opening area, so that blood can quickly and smoothly flow out; the tensile property result shows that the fracture strength of the valve leaflet is increased to a certain extent, the elastic modulus is obviously increased, the mechanical support property of the valve leaflet is favorably enhanced, the valve leaflet can bear high blood pressure in diastole, and the adverse phenomena of fracture, prolapse, collapse and the like do not occur; in addition, the obvious increase of the elastic modulus has positive influence on improving the stability of the valve blades in opening and closing movement, and the shaking/beating phenomenon can be avoided when the thickness is very small.

As shown in FIG. 20, the radially reinforced textile-based prosthetic heart valve has excellent hemodynamic performance, and the effective opening area of the radially reinforced textile-based prosthetic heart valve is 1.98cm as detected by an in vitro pulsating flow performance tester²The reflux fraction is 10.58 percent, the average cross-valve pressure difference is 4.12mmHg, and the national standard GB 12279-2008 and the international standard ISO 5840 are both met; matched with various mechanical property test results of valve leaflets, the radially enhanced textile-based artificial heart valve has the advantages of large effective opening area, small average trans-valve pressure difference (easy opening in the contraction phase), small reflux fraction (easy closing in the diastole phase), stable motion and good mechanical support (no trembling)Phenomena of movement and collapse). The hemodynamic performance index showed different improvements compared to the control: the Effective Open Area (EOA) is 1.13 times that of the control sample, and the average transpetal pressure difference (MDP) is 0.95 times that of the control sample; the change of the pressure difference between two sides can be quickly responded in the contraction period: the opening area at the same moment is 1.00-1.42 times of that of the comparison sample, the relation between the opening area at each moment and the multiple of the comparison sample is shown in table 4, and the time for maintaining the maximum opening area is 1.15 times of that of the comparison sample.

The stress and strain values for the polymeric material portion of the radially reinforced textile-based prosthetic heart valve obtained from the finite element analysis showed different reductions compared to the control: the maximum equivalent stress is 0.76 times that of the control, and the maximum equivalent strain is 0.75 times that of the control. This shows that the introduction of the reinforcing yarn effectively relieves the stress concentration phenomenon on the polymer material, and has an important influence on the improvement of the valve durability.

Example 2

A radially reinforced textile-based heart valve prosthesis for use as a surgical valve, the heart valve prosthesis having a diameter of 21mm and comprising three textile-based leaflets, wherein the textile-based leaflets are divided into four regions, namely a bottom region, a belly region, a coaptation region and a free edge, and a fabric is formed by interweaving radial yarns in the radial direction of the textile-based leaflets and circumferential yarns in the circumferential direction of the textile-based leaflets (the structure is shown in Table 3); the radial yarns consisted of reinforcing yarns (see tables 1 and 3) and polymeric yarns (see tables 2 and 3); when weaving, the warp density on the machine is 450 pieces/10 cm, and the weft density on the machine is 450 pieces/10 cm; in addition, when the textile base valve leaf is in a plane state, the included angle between the radial yarn and the radial central symmetry axis of the valve leaf is 0 degree (the position relation is W3), and the number of the reinforcing yarn accounts for 5 percent of the total number of the radial yarn; in the same textile basic lobe, the reinforced yarns are distributed in a centrosymmetric manner in a uniform distribution mode A; the penetrating mode of the reinforcing yarns on the valve leaflets is a penetrating mode II;

the free edge of the textile base valve leaf is arc-shaped; the thickness of the textile base valve leaf is 0.13 mm;

the bending rigidity of the radially reinforced textile base valve leaflet is 0.8 mN.mm; the breaking strength is 50.43MPa, and the elastic modulus is 206.76 MPa; the radial mechanical properties of the radially reinforced textile-based leaflets show different degrees of improvement compared to the control: the bending rigidity is 1.06 times of that of the comparison sample, the acute elastic recovery angle is 10 degrees larger than that of the comparison sample, the breaking strength is 1.10 times of that of the comparison sample, and the elastic modulus is 1.19 times of that of the comparison sample; the control only differs from the textile base leaflet by replacing the reinforcing yarn with a polymeric yarn;

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 2.08cm through the detection of an in vitro pulsating flow performance tester²The reflux fraction is 8.20 percent, the average cross-valve pressure difference is 2.96mmHg, and the national standard GB 12279-; the radially enhanced textile-based prosthetic heart valve is quickly closed in diastole and easily opened in systole, and has no shaking and collapse phenomena; compared with a comparison sample, the hemodynamic performance indexes of the radially enhanced textile-based artificial heart valve are improved to different degrees: the Effective Open Area (EOA) is 1.05 times of that of the comparative sample, and the average transpetal pressure difference (MDP) is 1.00 times of that of the comparative sample; the change of the pressure difference between two sides can be quickly responded in the contraction period: the opening area at the same moment is 1.00-1.42 times of that of the comparison sample, and the relation between the opening area at each moment and the multiple of the comparison sample is shown in a table 4; the time for maintaining the maximum opening area is 1.10 times of that of the comparison sample; compared with a comparison sample, the stress and strain values of the polymer material part obtained by finite element analysis show different degrees of reduction: the maximum equivalent stress is 0.87 times that of the control sample, and the maximum equivalent strain is 0.85 times that of the control sample.

Example 3

A radially reinforced textile-based prosthetic heart valve for use as a transcatheter prosthetic heart valve, the prosthetic heart valve having a diameter of 23mm and comprising three textile-based valve leaflets; the textile base valve leaf is divided into four areas, namely a bottom area, an abdomen area, a joint area and a free edge, and is made of a fabric formed by interweaving radial yarns in the radial direction of the textile base valve leaf and circumferential yarns in the circumferential direction of the textile base valve leaf (the weave structure is shown in table 3); the radial yarns consisted of reinforcing yarns (see tables 1 and 3) and polymeric yarns (see tables 2 and 3); when weaving, the upper warp density of the warp yarns of the two systems is 350 pieces/10 cm, and the upper weft density is 350 pieces/10 cm; and the textile basic valve leaf is in a plane state, the included angle between the radial yarn and the radial central symmetry axis of the valve leaf is 30 degrees (the position relation is W5), and the number of the reinforced yarn accounts for 15 percent of the total number of the radial yarn; in the same textile basic lobe, the reinforced yarns are distributed in a centrosymmetric manner in a unit uniform distribution B; the penetrating mode of the reinforcing yarns on the valve leaflets is a penetrating mode I;

the free edge of the textile base valve leaf is a straight line; the thickness of the textile base valve leaf is 0.13 mm;

the bending rigidity of the radially reinforced textile base valve leaflet is 1.6 mN.mm; the breaking strength is 576.97MPa, and the elastic modulus is 1285.45 MPa; the radial mechanical properties of the radially reinforced textile base leaflet showed different improvements compared to the control: the bending rigidity is 1.11 times of that of a comparison sample, the acute elastic recovery angle is 44 degrees larger than that of the comparison sample, the breaking strength is 1.19 times of that of the comparison sample, and the elastic modulus is 1.74 times of that of the comparison sample; the control only differs from the textile base leaflet by replacing the reinforcing yarn with a polymeric yarn;

the radially enhanced textile-based prosthetic heart valve has excellent hemodynamic performance, and the effective opening area of the radially enhanced textile-based prosthetic heart valve is 2.13cm through the detection of an in vitro pulsating flow performance tester²The reflux fraction is 10.76 percent, the average cross-valve pressure difference is 3.98mmHg, and the national standard of GB 12279-; the radially enhanced textile-based prosthetic heart valve is quickly closed in diastole and easily opened in systole, and has no shaking and collapse phenomena; compared with the comparison sample, the hemodynamic performance indexes of the radially enhanced textile-based artificial heart valve are improved to different degrees: the Effective Open Area (EOA) was 1.19 times that of the control, and the average transpetal differential pressure (MDP) was 0.89 times that of the control; the change of the pressure difference between two sides can be quickly responded in the contraction period: the opening area at the same moment is 1.00-1.42 times of that of the comparison sample, and the relation between the opening area at each moment and the multiple of the comparison sample is shown in a table 4; the time for maintaining the maximum opening area is 1.21 times that of the comparative sample; compared with the control sampleThe stress and strain values of the polymer material part obtained by finite element analysis show reduction in different degrees: the maximum equivalent stress is 0.65 times that of the control sample, and the maximum equivalent strain is 0.69 times that of the control sample.

Example 4

A radially reinforced textile-based prosthetic heart valve for use as a surgical valve, the prosthetic heart valve having a diameter of 25mm and comprising two textile-based valve leaflets; the textile base valve leaf is divided into four areas, namely a bottom area, an abdomen area, a joint area and a free edge, and is made of a fabric formed by interweaving radial yarns in the radial direction of the textile base valve leaf and circumferential yarns in the circumferential direction of the textile base valve leaf (the weave structure is shown in table 3); the radial yarns consisted of reinforcing yarns (see tables 1 and 3) and polymeric yarns (see tables 2 and 3); when weaving, the warp density of the machine is 300 pieces/10 cm, and the weft density of the machine is 300 pieces/10 cm; in addition, when the textile basic valve leaflet is in a plane state, the included angle between the radial yarn and the radial central symmetry axis of the valve leaflet is 45 degrees (the position relation is W3), and the number of the reinforcing yarn accounts for 20 percent of the total number of the radial yarn; in the same textile basic lobe, the reinforced yarns are distributed in a central symmetry way, and the distribution mode is that the units are uniformly distributed C; the penetrating mode of the reinforcing yarns on the valve leaflets is a penetrating mode IV;

the free edge of the textile base valve leaf is arc-shaped; the thickness of the textile base valve leaf is 0.18 mm;

the bending rigidity of the radially reinforced textile base valve leaflet is 2.3 mN.mm; the breaking strength is 187.09MPa, and the elastic modulus is 58.90 MPa; the radial mechanical properties of the radially reinforced textile base leaflet showed different improvements compared to the control: the bending rigidity is 1.13 times of that of a comparison sample, the acute elastic recovery angle is 59 degrees larger than that of the comparison sample, the breaking strength is 1.22 times of that of the comparison sample, and the elastic modulus is 1.98 times of that of the comparison sample; the control only differs from the textile base leaflet by replacing the reinforcing yarn with a polymeric yarn;

the radially enhanced textile-based prosthetic heart valve has excellent hemodynamic performance, and the effective opening area of the radially enhanced textile-based prosthetic heart valve is 1.56cm through the detection of an in vitro pulsating flow performance tester²The reflux fraction was 12.98%, and the average transvalvular pressure difference was7.85mmHg, which both meet the national standard GB 12279-; the radially enhanced textile-based prosthetic heart valve is quickly closed in diastole and easily opened in systole, and has no shaking and collapse phenomena; compared with a comparison sample, the hemodynamic performance indexes of the radially enhanced textile-based artificial heart valve are improved to different degrees: the Effective Open Area (EOA) was 1.10 times that of the control sample, and the average transpetal differential pressure (MDP) was 0.82 times that of the control sample; the change of the pressure difference between two sides can be quickly responded in the contraction period: the opening area at the same moment is 1.00-1.42 times of that of the comparison sample, and the relation between the opening area at each moment and the multiple of the comparison sample is shown in a table 4; the time for maintaining the maximum opening area is 1.27 times that of the comparison sample; compared with a comparison sample, the stress and strain values of the polymer material part obtained by finite element analysis show different degrees of reduction: the maximum equivalent stress is 0.60 times that of the control sample, and the maximum equivalent strain is 0.62 times that of the control sample.

Example 5

A radially reinforced textile-based prosthetic heart valve for use as a tissue-engineered heart valve, for minimally invasive intervention, the prosthetic heart valve having a diameter of 21mm and comprising three textile-based valve leaflets; the textile base valve leaf is divided into four areas, namely a bottom area, an abdomen area, a joint area and a free edge, and is made of a fabric formed by interweaving radial yarns in the radial direction of the textile base valve leaf and circumferential yarns in the circumferential direction of the textile base valve leaf (the weave structure is shown in table 3); the radial yarns consisted of reinforcing yarns (see tables 1 and 3) and polymeric yarns (see tables 2 and 3); when weaving, the warp density of the machine is 200 pieces/10 cm, and the weft density of the machine is 300 pieces/10 cm; in addition, when the textile base valve leaf is in a plane state, the included angle between the radial yarn and the radial central symmetry axis of the valve leaf is 0 degree (the position relation is W1), and the number of the reinforcing yarn accounts for 8 percent of the total number of the radial yarn; and in the same textile base lobe; the reinforced yarns are distributed in a centrosymmetric manner in a unit uniform distribution mode D; the penetrating mode of the reinforcing yarns on the valve leaflets is a penetrating mode III;

the free edge of the textile base valve leaf is arc-shaped; the thickness of the textile base valve leaf is 0.3 mm;

the bending rigidity of the radially reinforced textile base valve leaflet is 1.5 mN.mm; the breaking strength is 5.80MPa, and the elastic modulus is 5.09 MPa; the radial mechanical properties of the radially reinforced textile base leaflet showed different improvements compared to the control: the bending rigidity is 1.07 times of that of a comparison sample, the acute elastic recovery angle is 22 degrees larger than that of the comparison sample, the breaking strength is 1.12 times of that of the comparison sample, and the elastic modulus is 1.35 times of that of the comparison sample; the control only differs from the textile base leaflet by replacing the reinforcing yarn with a polymeric yarn;

the radially enhanced textile-based prosthetic heart valve has excellent hemodynamic performance, and the effective opening area of the radially enhanced textile-based prosthetic heart valve is 1.82cm through the detection of an in vitro pulsating flow performance tester²The reflux fraction is 6.29 percent, the average cross-valve pressure difference is 3.69mmHg, and the national standard of GB 12279-; the radially enhanced textile-based prosthetic heart valve is quickly closed in diastole and easily opened in systole, and has no shaking and collapse phenomena; compared with a comparison sample, the hemodynamic performance indexes of the radially enhanced textile-based artificial heart valve are improved to different degrees: the Effective Open Area (EOA) is 1.05 times of that of the comparative sample, and the average transpetal pressure difference (MDP) is 0.97 times of that of the comparative sample; the change of the pressure difference between two sides can be quickly responded in the contraction period: the opening area at the same moment is 1.00-1.42 times of that of the comparison sample, and the relation between the opening area at each moment and the multiple of the comparison sample is shown in a table 4; the time for maintaining the maximum opening area is 1.13 times that of the comparative sample; compared with a comparison sample, the stress and strain values of the polymer material part obtained by finite element analysis show different degrees of reduction: the maximum equivalent stress is 0.54 times that of the control sample, and the maximum equivalent strain is 0.81 times that of the control sample.

Example 6

A radial reinforced textile-based heart valve prosthesis is used as a tissue engineering heart valve and intervenes in a minimally invasive manner, has the diameter of 25mm, comprises three textile-based valve leaflets, wherein the textile-based valve leaflets are divided into four areas, namely a bottom area, an abdomen area, a joint area and a free edge, and is made of a fabric formed by interweaving radial yarns in the radial direction of the textile-based valve leaflets and circumferential yarns in the circumferential direction of the textile-based valve leaflets (the tissue structure is shown in table 3); the radial yarns consisted of reinforcing yarns (see tables 1 and 3) and polymeric yarns (see tables 2 and 3); when weaving, the warp density of the upper machine is 150 pieces/10 cm, and the weft density of the upper machine is 150 pieces/10 cm; in addition, when the textile basic valve leaflet is in a plane state, the included angle between the radial yarn and the radial central symmetry axis of the valve leaflet is 45 degrees (the position relation is W3), and the number of the reinforcing yarn accounts for 30 percent of the total number of the radial yarn; in the same textile basic lobe, the reinforced yarns are distributed in a centrosymmetric manner in a uniform distribution mode A; the penetrating mode of the reinforcing yarns on the valve leaflets is a penetrating mode V;

the free edge of the textile base valve leaf is a straight line; the thickness of the textile base leaflet is 0.16 mm;

the bending rigidity of the radially reinforced textile base valve leaflet is 1.8 mN.mm; the breaking strength is 10.94MPa, and the elastic modulus is 13.89 MPa; the radial mechanical properties of the radially reinforced textile base leaflet showed different improvements compared to the control: the bending rigidity is 1.16 times of that of a comparison sample, the acute elastic recovery angle is 64 degrees larger than that of the comparison sample, the breaking strength is 1.25 times of that of the comparison sample, and the elastic modulus is 2.20 times of that of the comparison sample; the control only differs from the textile base leaflet by replacing the reinforcing yarn with a polymeric yarn;

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 2.69cm when the in vitro pulsating flow performance tester detects that²The reflux fraction is 14.65 percent, the average cross-valve pressure difference is 8.88mmHg, and the national standard GB 12279-2008 and the international standard ISO 5840 are both met; the radially enhanced textile-based prosthetic heart valve is quickly closed in diastole and easily opened in systole, and has no shaking and collapse phenomena; compared with a comparison sample, the hemodynamic performance indexes of the radially enhanced textile-based artificial heart valve are improved to different degrees: the Effective Open Area (EOA) was 1.24 times that of the control, and the average transpetal pressure difference (MDP) was 0.78 times that of the control; the change of the pressure difference between two sides can be quickly responded in the contraction period: the opening area at the same moment is 1.00-1.42 times of that of the comparison sample, and the relation between the opening area at each moment and the multiple of the comparison sample is shown in a table 4; the time for maintaining the maximum opening area is the control1.33 times; compared with a comparison sample, the stress and strain values of the polymer material part obtained by finite element analysis show different degrees of reduction: the maximum equivalent stress is 0.49 times that of the control sample, and the maximum equivalent strain is 0.57 times that of the control sample.

Example 7

A radial reinforced textile-based heart valve prosthesis is used as a tissue engineering heart valve and intervenes in a minimally invasive manner, has the diameter of 23mm, comprises three textile-based valve leaflets, wherein the textile-based valve leaflets are divided into four areas, namely a bottom area, an abdomen area, a joint area and a free edge, and is made of a fabric formed by interweaving radial yarns in the radial direction of the textile-based valve leaflets and circumferential yarns in the circumferential direction of the textile-based valve leaflets (the tissue structure is shown in table 3); the radial yarns consisted of reinforcing yarns (see tables 1 and 3) and polymeric yarns (see tables 2 and 3); when weaving, the warp density of the upper machine is 2000 pieces/10 cm, and the weft density of the upper machine is 2000 pieces/10 cm; in addition, when the textile basic valve leaflet is in a plane state, the included angle between the radial yarn and the radial central symmetry axis of the valve leaflet is 0 degree (the position relation is W1), and the number of the reinforcing yarn accounts for 50 percent of the total number of the radial yarn; in the same textile basic lobe, the reinforced yarns are distributed in a centrosymmetric manner in a unit uniform distribution mode D; the penetrating mode of the reinforcing yarns on the valve leaflets is a penetrating mode VI;

the free edge of the textile base valve leaf is arc-shaped; the thickness of the textile base valve leaf is 0.06 mm;

the bending stiffness of the radially reinforced textile base leaflet is 2.5 mN.mm; the breaking strength is 13.98MPa, and the elastic modulus is 16.32 MPa; the radial mechanical properties of the radially reinforced textile base leaflet showed different improvements compared to the control: the bending rigidity is 1.23 times of that of a comparison sample, the acute elastic recovery angle is 80 degrees larger than that of the comparison sample, the breaking strength is 1.37 times of that of the comparison sample, and the elastic modulus is 2.51 times of that of the comparison sample; the control only differs from the textile base leaflet by replacing the reinforcing yarn with a polymeric yarn;

the radially enhanced textile-based prosthetic heart valve has excellent hemodynamic performance, and the effective opening area of the radially enhanced textile-based prosthetic heart valve is 2.78c detected by an in vitro pulsating flow performance testerm²The reflux fraction is 13.90 percent, the average cross-valve pressure difference is 9.71mmHg, and the national standard GB 12279-2008 and the international standard ISO 5840 are both met; the radially enhanced textile-based prosthetic heart valve is quickly closed in diastole and easily opened in systole, and has no shaking and collapse phenomena; compared with a comparison sample, the hemodynamic performance indexes of the radially enhanced textile-based artificial heart valve are improved to different degrees: the Effective Open Area (EOA) was 1.36 times that of the control, and the average transpetal differential pressure (MDP) was 0.68 times that of the control; the change of the pressure difference between two sides can be quickly responded in the contraction period: the opening area at the same moment is 1.00-1.42 times of that of the comparison sample, and the relation between the opening area at each moment and the multiple of the comparison sample is shown in a table 4; the time for maintaining the maximum opening area is 1.50 times that of the control sample; compared with a comparison sample, the stress and strain values of the polymer material part obtained by finite element analysis show different degrees of reduction: the maximum equivalent stress is 0.39 times that of the control sample, and the maximum equivalent strain is 0.46 times that of the control sample.

Example 8

A radial reinforced textile-based heart valve prosthesis used as a valved conduit, the diameter of the heart valve prosthesis is 23mm, the heart valve prosthesis comprises three textile-based valve leaflets, wherein the textile-based valve leaflets are divided into four areas of a bottom part, an abdomen part, a joint area and a free edge, and the textile-based valve leaflets are made of fabrics formed by interweaving radial yarns in the radial direction of the textile-based valve leaflets and circumferential yarns in the circumferential direction of the textile-based valve leaflets (the tissue structure is shown in a table 3); the radial yarns consisted of reinforcing yarns (see tables 1 and 3) and polymeric yarns (see tables 2 and 3); when weaving, the warp density of the upper machine is 1500 pieces/10 cm, and the weft density of the upper machine is 1800 pieces/10 cm; in addition, when the textile base valve leaf is in a plane state, the included angle between the radial yarn and the radial central symmetry axis of the valve leaf is 0 degree (corresponding position relation W1), and the number of the reinforcing yarn accounts for 40 percent of the total number of the radial yarn; in the same textile basic lobe, the reinforced yarns are distributed in a centrosymmetric manner in a unit uniform distribution mode E; the penetrating mode of the reinforcing yarns on the valve leaflets is a penetrating mode II;

the free edge of the textile base valve leaf is a straight line; the thickness of the textile base leaflet is 0.08 mm;

the bending rigidity of the radially reinforced textile base valve leaflet is 2.4 mN.mm; the breaking strength is 106.82MPa, and the elastic modulus is 49.75 MPa; the radial mechanical properties of the radially reinforced textile base leaflet showed different improvements compared to the control: the bending rigidity is 1.20 times of that of a comparison sample, the acute elastic recovery angle is 72 degrees larger than that of the comparison sample, the breaking strength is 1.29 times of that of the comparison sample, and the elastic modulus is 2.39 times of that of the comparison sample; the control only differs from the textile base leaflet by replacing the reinforcing yarn with a polymeric yarn;

the radially enhanced textile-based prosthetic heart valve has excellent hemodynamic performance, and the effective opening area of the radially enhanced textile-based prosthetic heart valve is 2.56cm through the detection of an in vitro pulsating flow performance tester²The reflux fraction is 13.78 percent, the average cross-valve pressure difference is 9.05mmHg, and the national standard GB 12279-2008 and the international standard ISO 5840 are both met; the radially enhanced textile-based prosthetic heart valve is quickly closed in diastole and easily opened in systole, and has no shaking and collapse phenomena; compared with a comparison sample, the hemodynamic performance indexes of the radially enhanced textile-based artificial heart valve are improved to different degrees: the Effective Open Area (EOA) was 1.29 times that of the control, and the average transpetal differential pressure (MDP) was 0.72 times that of the control; the change of the pressure difference between two sides can be quickly responded in the contraction period: the opening area at the same moment is 1.00-1.42 times of that of the comparison sample, and the relation between the opening area at each moment and the multiple of the comparison sample is shown in a table 4; the time for maintaining the maximum opening area is 1.40 times that of the control sample; compared with a comparison sample, the stress and strain values of the polymer material part obtained by finite element analysis show different degrees of reduction: the maximum equivalent stress is 0.43 times that of the control sample, and the maximum equivalent strain is 0.52 times that of the control sample.

TABLE 1 reinforcing yarns and their numbering in examples 1-8

TABLE 2 Polymer yarns and their numbering in examples 1 to 8

TABLE 3 raw materials of yarns of examples 1 to 8, their texture and parameters

TABLE 4

Claims

1. A radially reinforced textile-based prosthetic heart valve comprising textile-based leaflets, characterized by: the radial yarns of the textile base valve leaf comprise reinforcing yarns and high polymer yarns;

the textile base valve leaflet is formed by interweaving the radial yarns and the circumferential yarns; the radial yarns refer to yarns in the radial direction of the textile base valve leaf, and the circumferential yarns refer to yarns in the circumferential direction of the textile base valve leaf;

the reinforced yarn is a metal wire or a composite yarn formed by the metal wire and polymer fibers;

the number of the reinforced yarns accounts for 1-50% of the total number of the radial yarns;

the radially-reinforced textile-based prosthetic heart valve comprises two or three textile-based valve leaflets, and the reinforcing yarns are distributed in a central symmetry manner in the same textile-based valve leaflet;

in the planar state of the textile base valve leaflet, the included angle between the radial yarn and the radial central symmetry axis of the valve leaflet is 0 degree, 30 degrees or 45 degrees;

the textile base valve leaf is divided into four areas, namely a bottom area, an abdomen area, a jointing area and a free edge; the reinforcing yarns extend at least through the abdomen.

2. The radially reinforced textile-based prosthetic heart valve of claim 1, wherein the radial yarns are comprised of the reinforcing yarns and polymeric yarns.

3. The radially-reinforced textile-based prosthetic heart valve of claim 1, wherein the circumferential yarns are polymeric yarns.

4. A radially reinforced textile-based prosthetic heart valve according to claim 1, wherein the metal wire is a shape memory alloy wire.

5. A radially reinforced textile-based prosthetic heart valve according to claim 1, wherein the reinforcing yarns are continuous throughout at least the base and the abdomen.

6. The radially-reinforced, textile-based prosthetic heart valve of claim 5, wherein said textile-based leaflet is comprised of bi-directional fabric or planar tri-directional fabric; the weave structure of the bidirectional fabric comprises one or more of plain weave, twill weave, satin weave, plain weave change, twill change, satin change, heavy weave, double-layer weave and multi-layer weave; the weave structure of the plane three-way fabric comprises one or more of plain three-way weave, twill three-way weave and double plain three-way weave.

7. The radially reinforced textile-based prosthetic heart valve of claim 1, wherein the textile-based leaflet is woven with a warp density of 150-2000 threads/10 cm and a weft density of 150-2000 threads/10 cm.

8. The radially reinforced textile-based prosthetic heart valve of claim 1, wherein the textile-based leaflet has a thickness of 0.05-0.3 mm, and the reinforcing yarn and the polymeric yarn each have a diameter of less than 0.2 mm.