CN119868015A

CN119868015A - Suture preparation method of polymer valve and related products

Info

Publication number: CN119868015A
Application number: CN202510368383.6A
Authority: CN
Inventors: 马艳; 张晓玉; 臧美娜; 王翔宇
Original assignee: National Cerebral and Cardiovascular Center
Current assignee: National Cerebral and Cardiovascular Center
Priority date: 2025-03-27
Filing date: 2025-03-27
Publication date: 2025-04-25

Abstract

The present application discloses a method for preparing a polymer valve by suturing and related products, belonging to the field of heart valve technology, the method comprising: aligning the holes at the midpoints of the three sides of the leaflet with the lower part of the sewn second valve seat, suturing continuously to the second valve seat through the punching position, folding the reserved part and suturing it, and then wrapping the suture around the valve seat wrapping cloth and passing it out; aligning the sewn second valve frame and the sewn second valve seat, and extending the three hole sutures to the apex of the second valve seat, and alternately suturing through the valve frame wrapping cloth, the reserved hole positions of the leaflet, and the valve seat wrapping cloth in turn, until the apex of the second valve seat and tying and fixing it to obtain the valve body; fixing the valve ring under the second valve seat in the valve body to obtain the polymer valve. Through the scheme of the present application, the valve sewing accuracy can be improved and the structural strength of the reinforced suture area can be enhanced.

Description

Suture preparation method of polymer valve and related products

Technical Field

The application relates to the field of heart valves, in particular to a suture preparation method of a polymer valve and a related product.

Background

Prosthetic heart valve replacement surgery is an important means of treating heart valve lesions, where the choice of prosthetic heart valve is directly related to the long-term effect of the surgery and the quality of life of the patient. In the prior art, the artificial heart valve mainly comprises two major types of mechanical valves and biological valves, and the two types of valves have respective technical limitations in clinical application. The mechanical valve is made of titanium alloy, pyrolytic carbon and other artificial materials, and the valve She Kaige mechanism of the mechanical valve usually comprises a single blade, a double blade or a ball cage type and other structural forms. Because the mechanical flap has excellent mechanical property and durability, the theoretical service life can reach more than 20 years. However, a key technical disadvantage of mechanical petals is that their artificial material surfaces are poorly hemocompatible, easily inducing platelet aggregation and coagulation factor activation, leading to a significant increase in the risk of thrombosis. In order to prevent thromboembolic complications, patients receiving mechanical valve replacement must take anticoagulant drugs such as warfarin for life, which not only increases the risk of bleeding, but also brings great medication burden and inconvenience to life to the patients. The biological valve is made of special treated heteropericardium (such as bovine pericardium and porcine pericardium) or autologous tissue, and has tissue structure similar to natural valve, good blood compatibility, and long-term anticoagulation is not needed. However, the main technical difficulty of the biological valve is that the biological valve is insufficient in durability, calcification and tissue degeneration are easy to occur after the biological valve is implanted into a body, and the biological valve is often required to be operated again within 10-15 years. In addition, the existing biological valve has complex preparation process, high quality control difficulty and high production cost, and is restricted to be further popularized and used.

In response to the inherent shortcomings of mechanical and biological valves, researchers have recently disclosed novel prosthetic heart valve technology routes based on polymeric materials. The high molecular valve adopts a precise processing technology to manufacture the valve leaflet structure by selecting synthetic materials with specific mechanical properties and biocompatibility, such as polyurethane, polycarbonate and the like, so as to try to achieve the balance between durability and blood compatibility. The valve leaflet material of the valve can be optimized through molecular design and surface modification technology, and the mechanical property and blood compatibility close to those of the natural valve can be obtained theoretically. At present, researchers have developed various improved polymer valves, including technical schemes of reinforcing the valve She Du by using a nanocomposite material, improving antithrombotic property by using a surface patterning technology, introducing bioactive molecules to promote endothelialization, and the like. However, the actual performance of a polymeric valve is largely dependent on the accuracy and controllability of its fabrication process. Particularly, at the connection part of the valve leaflet and the bracket, the current manual sewing method has the problems of insufficient operation precision, uneven connection strength and the like, and a stress concentration area is easy to form, so that the valve leaflet is damaged early. Meanwhile, the high polymer material may have fatigue damage, stress relaxation and other aging phenomena under long-term cyclic load, and the durability evaluation and prediction of the high polymer material still face challenges.

Therefore, a technical solution is needed to improve the sewing accuracy of the valve and strengthen the structural strength of the reinforced sewing region.

Disclosure of Invention

In order to solve the defects in the prior art, the embodiment of the application discloses a suture preparation method of a polymer valve and related products. The application solves the technical problems of uneven connection strength, easy formation of stress concentration areas and the like in the prior art.

The embodiment of the application discloses a sewing preparation method of a polymer valve, which comprises the steps of cutting valve seat wrapping cloth, folding, ironing and shaping, adopting cross sewing to form a cylinder, placing a first valve seat in the cylinder formed by sewing, adopting a back needle for sewing and fixing, continuously sewing and fixing redundant parts after being folded to obtain a sewn second valve seat, manufacturing valve seat wrapping cloth according to a three-dimensional model unfolding diagram of the first valve seat, adopting oblique lines to stitch and iron a joint of a back needle for sewing, placing the first valve seat in the valve seat and fixing the back needle for sewing so as to obtain the sewn second valve seat, sewing holes at the middle points of three sides of a valve leaf with the lowest part of the sewn second valve seat, continuously sewing other holes preset at each side from the middle points of the three sides to the top end of the second valve seat, threading the suture wrapping cloth out of the valve seat after being folded and sewn, enabling the suture to extend to the top of the second valve seat through holes at the middle points of three sides of the valve leaf to the top of the second valve seat after sewing, sequentially fixing the valve seat through the hole positions of the middle points of the three sides of the valve leaf to the top of the second valve seat, and fixing the valve seat after sewing, and fixing the valve seat to obtain a main body after sewing. In one possible implementation, the flap seat wrapping cloth is cut, folded, ironed and shaped, a cross stitch is adopted to manufacture a cylinder, a first flap seat is arranged in the stitched cylinder, a back stitch is adopted to stitch and fix, and the redundant part is continuously stitched and fixed after being folded, so as to obtain a second flap seat after being sewn, the method comprises the steps of cutting the flap seat wrapping cloth according to the three-dimensional shape characteristics of the first flap seat, and enabling one side edge of the flap seat wrapping cloth to be longer than the other side edge; the method comprises the steps of folding flap seat wrapping cloth in half, ironing at folds by adopting ironing equipment, opening the flap seat wrapping cloth, sewing the left end and the right end of the flap seat wrapping cloth into a cylindrical structure by adopting cross stitching, putting a first flap seat into the cylindrical flap seat wrapping cloth, sewing and fixing by adopting a needle return, folding redundant flap seat wrapping cloth, and fixing on the flap seat wrapping cloth by adopting continuous sewing to obtain a second sewn flap seat.

In one possible implementation, the method comprises making a valve frame wrapping cloth according to a three-dimensional model unfolding diagram of a first valve frame, sewing and ironing a joint by adopting diagonal stitch and needle return sewing and fixing the first valve frame in the joint to obtain a sewn second valve frame, and comprises building a three-dimensional curved surface model according to the width and circumference of the first valve frame and unfolding the model into a plan diagram to make the valve frame wrapping cloth; folding the flap frame wrapping cloth according to the wrapping layer number and ironing out marks, adopting oblique line connection to close a return needle to stitch at the joint of the flap frame wrapping cloth, unfolding triangular cloth formed at the joint and ironing the joint to be flat, cutting redundant parts, ironing the joint again according to the marks, placing the first flap frame into the flap frame wrapping cloth, and adopting the return needle to stitch and fix the two folded ends so as to ensure that a gap is reserved between the flap frame wrapping cloth and the first flap frame, thereby obtaining a second flap frame after sewing.

In an implementation mode, a hole site at the midpoint of three sides of the valve leaflet is matched with the lowest position of a sewn second valve seat, other hole sites which are preset on each side are uniformly distributed from the midpoints of the three sides, the suture is continuously sewn to the top end of the second valve seat, the suture wound around the valve seat is wrapped out after being folded and sewn from the valve She Yuliu part, the hole site at the midpoint of the three sides of the valve leaflet is matched with the lowest position of the second valve seat respectively, a suture is threaded from the hole site at the midpoint of each side of the valve leaflet and the matched valve seat wrapping cloth, the two ends of the suture are utilized to stitch the valve leaflet and the second valve seat together through uniformly distributed other hole sites which are preset on each side of the valve leaflet until the two ends of each suture pass through the first hole site of each side of the valve leaflet, the suture which passes through the first hole site is respectively threaded from the second hole site and the third hole site of the reserved part of the valve leaflet on the side adjacent to the first hole site, the knotted suture is respectively knotted, the knotted thread is wound around the corresponding second valve seat top end from the opposite directions, and the suture is wrapped out from the top end of the valve seat She Duiying of the valve seat.

In an implementation mode, a second sewn valve frame and a second sewn valve seat are combined, a suture thread extends to the vertex of the second valve seat through hole sites at the middle points of three edges of the valve leaf, alternate suturing is conducted through valve frame wrapping cloth, reserved hole sites of the valve leaf and valve seat wrapping cloth in sequence until the vertex of the second valve seat is knotted and fixed, the suture thread penetrates out of the hole sites at the middle points of the three edges of the valve leaf respectively, the suture needle sequentially penetrates through the valve frame wrapping cloth, the reserved hole sites of the valve leaf and the valve seat wrapping cloth to complete first suture, second suture is conducted through the valve leaf and the second valve frame from the second valve seat, and the suturing step is repeated until the suture thread penetrates through the vertex of the second valve seat and is knotted and fixed.

In one possible implementation, the method for sewing and fixing the valve annulus below the second valve seat in the valve main body to obtain the polymer valve comprises the steps of aligning the short ends of the valve annulus wrapping cloth, continuously sewing the valve annulus into a ring shape, placing the valve annulus in the middle of the valve annulus wrapping cloth, sewing the valve annulus into the valve annulus wrapping cloth by a needle hiding method, tightening a suture line to form a wrapped felt valve annulus, aligning the wrapped felt valve annulus with the bottom of the second valve seat, and continuously sewing and fixing the suture line through the felt valve annulus and a reserved hole of the second valve seat by a continuous sewing method.

In one possible implementation, a three-dimensional curved surface model is built according to the width and the circumference of a first valve frame and is unfolded into a plan view to manufacture a valve frame wrapping cloth, wherein the method comprises the steps of building a valve frame three-dimensional geometric body through control point coordinates and a Bernstein basis function and converting the valve frame three-dimensional geometric body into a quadrilateral grid model, building a Riemann metric tensor component calculation model, unfolding a three-dimensional curved surface into a two-dimensional plan view in combination with a cutting path, calculating the actual circumference of the valve frame, and determining the cutting size and the allowance of the cloth according to the wrapping layer number.

In one possible implementation, the method comprises the steps of establishing a valve frame three-dimensional geometric body through control point coordinates and a Bernstein basis function, and converting the valve frame three-dimensional geometric body into a quadrilateral mesh model, wherein the method comprises the steps of adopting a Bessel curved surface equation to construct a continuously-conductive valve frame three-dimensional geometric body, calculating a position vector of any point through the control point coordinates and the Bernstein basis function, converting a continuous curved surface into the quadrilateral mesh model, and carrying out mesh local encryption processing on local features of the valve frame surface.

In one possible implementation, a Riemann metric tensor component calculation model is established, and a three-dimensional curved surface is unfolded into a two-dimensional plan view in combination with a cutting path, wherein the method comprises the steps of determining a minimum strain energy cutting path of a valve frame surface, establishing the Riemann metric tensor component calculation model, unfolding the three-dimensional curved surface along the determined cutting path, and calculating two-dimensional coordinates of grid nodes by taking an unfolding reference point as a starting point.

The embodiment of the application also discloses a polymer valve applying the suturing preparation method according to any one of the embodiments, which comprises an annulus, a first valve seat, a first valve frame, valve leaves, valve frame wrapping cloth and valve seat wrapping cloth, wherein the annulus is arranged at the bottom of the valve, an annular structure is adopted, the upper surface of the annulus is connected with the first valve seat, the first valve seat is of an annular step structure, the outer peripheral wall of the bottom is matched with the annulus, the upper surface of the first valve seat is provided with a positioning structure matched with the first valve frame, the first valve frame is composed of three struts, the lower ends of the struts are fixedly connected with the positioning structure on the first valve seat, the upper ends of the struts are mutually connected to form a supporting structure, the valve leaves are made of polymer materials, the edges of the valve leaves are reserved with a plurality of holes and are fixedly connected with the first valve seat and the first valve frame through sutures, the valve frame wrapping cloth covers the surface of the first valve frame and is fixed in a needle-back suturing mode, and the valve seat wrapping cloth is wrapped on the outer surface of the first valve seat through a needle-back suturing mode.

In the method for preparing the high polymer valve by sewing and related products disclosed above, the embodiment of the application realizes more accurate structural control by introducing the multi-layer three-dimensional package structure and the special sewing process, can improve the sewing precision of the valve and strengthen the structural strength of a reinforced sewing region. Further, in some embodiments, by providing dimensional differences on the inside and outside, in combination with a special tension-free crisscross stitching process, smoothness of the wrapped structure on a microscopic scale is ensured, and optimal balance of structural stability and material stress distribution is achieved. Further, in some embodiments, structural stability during leaflet fixation is ensured by a three-point positioning and progressive suturing scheme, i.e., by providing specific perforation locations above the valve seat bottom edge, in combination with precise tension control. In particular, the two-way cross stitching technology is adopted at the joint of the vertexes, and the stress is uniformly distributed by controlling the stitching depth and the uniform stitch length. The process not only improves the structural strength, but also avoids the problem of local deformation common in the traditional process by tension control. Further, in some embodiments, a proper inclination angle is set by a diagonal connection stitch sewing method, and a special specification stitch is adopted for stitch sewing connection, so that the problem of pile up of thread ends at a joint in the traditional process is effectively solved. The ironing process under the specific temperature condition is combined, so that the flatness of the joint is ensured, and meanwhile, the mechanical property of the whole structure is improved by reserving proper operation allowance.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, and it is obvious that the drawings in the following description are some embodiments of the present application, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic flow chart of a method for preparing a polymer valve by suturing according to an embodiment of the present application;

FIG. 2 is a schematic illustration of a valve component according to an embodiment of the present disclosure;

FIG. 3 is a schematic view of another valve component disclosed in an embodiment of the present application;

FIG. 4 is a schematic illustration of a folded flap seat wrap according to an embodiment of the present application;

FIG. 5 is a schematic illustration of an alignment of a flap seat wrap in accordance with an embodiment of the present application;

FIG. 6 is a schematic view of a sewn flap seat according to an embodiment of the present application;

FIG. 7 is a schematic view of a sewn flap holder according to an embodiment of the present application;

FIG. 8 is a schematic diagram of sewing a leaflet and a leaflet seat according to an embodiment of the present application;

FIG. 9 is a schematic view of a valve frame fixation according to an embodiment of the present application;

Fig. 10 is a schematic diagram of a process for wrapping an annulus and suturing the wrapped annulus to a valve body to obtain a polymeric valve according to an embodiment of the present application.

The reference numerals indicate 110, annulus, 120, first valve seat, 130, first valve frame, 140, valve leaflet, 141, first hole site, 142, valve She Yuliu, 143, second hole site, 144, third hole site, 145, vertex hole site, 150, annulus wrapping cloth, 210, valve frame wrapping cloth, 220, valve seat wrapping cloth, 221, valve seat wrapping cloth crease, 222, valve seat wrapping cloth suture, 310, second valve seat, 320, second valve frame.

Detailed Description

Various exemplary embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. It should be noted that the relative arrangement of the components and steps, numerical expressions and numerical values set forth in these embodiments do not limit the scope of the present disclosure unless it is specifically stated otherwise.

It will be appreciated by those of skill in the art that the terms "first," "second," etc. in embodiments of the present disclosure are used merely to distinguish between different steps, devices or modules, etc., and do not represent any particular technical meaning nor necessarily logical order between them. It should also be understood that in embodiments of the present disclosure, "plurality" may refer to two or more, and "at least one" may refer to one, two or more. It should also be appreciated that any component, data, or structure referred to in the presently disclosed embodiments may be generally understood as one or more without explicit limitation or the contrary in the context. In addition, the term "and/or" in this disclosure is merely an association relation describing the association object, and indicates that three kinds of relations may exist, for example, a and/or B may indicate that a exists alone, and a and B exist together, and B exists alone. In addition, the character "/" in this disclosure generally indicates that the related object is an or relationship, and it should be further understood that the description of the embodiments in this disclosure emphasizes the differences between the embodiments, and the same or similar features may be referred to each other, so that they will not be repeated for brevity.

Meanwhile, it should be understood that the sizes of the respective parts shown in the drawings are not drawn in actual scale for convenience of description. The following description of at least one exemplary embodiment is merely illustrative in nature and is in no way intended to limit the disclosure, its application, or uses. Techniques, methods, and apparatus known to one of ordinary skill in the relevant art may not be discussed in detail, but are intended to be part of the specification where appropriate. It should be noted that like reference numerals and letters refer to like items in the following figures, and thus once an item is defined in one figure, no further discussion thereof is necessary in subsequent figures.

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present application more apparent, the technical solutions of the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application, and it is apparent that the described embodiments are some embodiments of the present application, but not all embodiments of the present application. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

Fig. 1 is a schematic flow chart of a method for preparing a polymer valve according to an embodiment of the present application.

It should be understood that the polymer valve is a novel valve, which is interposed between a biological valve and a mechanical valve, and the main components of the valve are shown in fig. 2 and 3, fig. 2 is a schematic perspective view of a valve component according to an embodiment of the present application, and fig. 3 is a schematic view of another valve component according to an embodiment of the present application, specifically, the components of the valve may include an annulus 110, a first valve seat 120, a first valve frame 130, a valve leaflet 140, a valve frame wrapping cloth 210, and a valve seat wrapping cloth 220. Wherein, the valve leaflet 140 is made of polymer material. Thus, how to stitch a high quality valve is particularly critical, except for the choice of materials.

As shown in fig. 1, at step S101, the flap seat wrapping cloth 220 is cut, folded, ironed and shaped, a cross stitch is adopted to make a tube shape, the first flap seat 120 is placed in the tube shape made by the stitch, and the needle return stitch is adopted to fix, and the redundant part is folded and then continuously stitched and fixed, so as to obtain the second flap seat 310 after sewing. The method comprises the steps of cutting flap seat wrapping cloth 220 according to the three-dimensional shape characteristics of a first flap seat 120, enabling one side edge to be longer than the other side edge, ironing the flap seat wrapping cloth at a crease by adopting ironing equipment after folding the flap seat wrapping cloth, opening the flap seat wrapping cloth, sewing the left end and the right end of the flap seat wrapping cloth into a cylindrical structure by adopting cross stitching, placing the first flap seat 120 into the cylindrical flap seat wrapping cloth, sewing and fixing the first flap seat 120 by adopting a back needle, folding the redundant flap seat wrapping cloth, and fixing the redundant flap seat wrapping cloth on the flap seat wrapping cloth 220 by adopting continuous sewing to obtain a sewn second flap seat 310.

For sewing the wrapped flap seat 120, in one embodiment, a flap seat wrapping cloth of a corresponding size is cut out according to the shape of the first flap seat 120, and the cut flap seat wrapping cloth is folded in half first, and as shown in fig. 3, the inner side and the outer side are bounded by a crease 221 of the flap seat wrapping cloth 220, and the inner side is longer than the outer side.

Fig. 4 is a schematic diagram of folding a flap seat wrapping cloth according to an embodiment of the present application, fig. 5 is an alignment schematic diagram of the flap seat wrapping cloth according to an embodiment of the present application, and fig. 6 is a schematic diagram of a sewn flap seat according to an embodiment of the present application. Referring to fig. 4, a stamp is formed by aligning and ironing the left and right ends of the folded flap seat wrapping cloth 220, referring to fig. 5 again, after the flap seat wrapping cloth is opened, the left and right ends are aligned and sewn by a cross stitch to obtain flap seat wrapping cloth sewing threads 222, the flap seat wrapping cloth is sewn into a barrel shape, the flap seat 120 is placed at the position of a crease 221 in the flap seat wrapping cloth, the flap seat is wrapped in the crease 221, the flap seat 120 is fixed in the flap seat wrapping cloth by a needle return sewing, and after the redundant flap seat wrapping cloth is folded, referring to fig. 6, the flap seat is continuously sewn on the flap seat wrapping cloth 220 to obtain the sewn flap seat 310.

Preferably, the valve seat wrap of a corresponding size is cut according to the three-dimensional shape characteristics of the first valve seat 120. In practice, the inside edge of the flap seat wrap should be about 4.5-5.0 mm longer than the outside edge, and this dimensional difference ensures smoothness after wrapping. The cut flap seat wrapping cloth is folded in half, and is ironed for about 15-20 seconds along folds by using medical ironing equipment at the temperature of about 121 ℃ to form the positioning mark. Unfolding the flap seat wrapping cloth, ensuring that the left end and the right end are aligned, and sewing the cloth into a cylindrical structure by adopting a tension-free crisscross sewing process. During sewing, the stitch length is kept between 3.0 and 3.5 mm, and the stitch length is 2.5 to 3.0 mm away from the edge of the cloth. The first valve seat 120 is placed at the crease 221 of the cylindrical valve seat wrapping cloth, the non-invasive suture with 5-0 specification is adopted for back stitch sewing and fixing, after fixing, the redundant valve seat wrapping cloth is folded inwards, the folding width is controlled between 5.0-5.5 mm, and finally the folding edge is fixed on the valve seat wrapping cloth 220 in a continuous sewing mode.

At step S102, a flap frame wrapping cloth is manufactured according to the three-dimensional model unfolding diagram of the first flap frame 130, the joint is sewn and ironed by adopting diagonal stitch and needle return, and the first flap frame 130 is placed in the flap frame wrapping cloth and needle return is sewn and fixed, so that the sewn second flap frame 320 is obtained. The method comprises the steps of building a three-dimensional curved surface model according to the width and the circumference of a first valve frame 130, unfolding the model into a plan view to manufacture valve frame wrapping cloth, folding the valve frame wrapping cloth according to the wrapping layer number, ironing marks, sewing a joint of the valve frame wrapping cloth 210 by adopting oblique lines, unfolding triangular cloth formed at the joint, ironing the joint to be flat, cutting redundant parts, ironing the joint again according to the marks, placing the first valve frame 130 into the valve frame wrapping cloth, sewing and fixing the folded two ends by adopting the back lines, so that a gap is reserved between the valve frame wrapping cloth and the first valve frame 130, and obtaining a sewn second valve frame 320.

Further, wherein the three-dimensional curved surface model is built according to the width and circumference of the first valve frame 130 and unfolded into a plan view to make the valve frame wrapping cloth, comprising:

firstly, a valve frame three-dimensional geometrical body is established through control point coordinates and a Bernstein base function and is converted into a quadrilateral mesh model, wherein the method comprises the steps of adopting a Bessel curved surface equation to construct a continuously-conductive valve frame three-dimensional geometrical body, calculating a position vector of any point through the control point coordinates and the Bernstein base function, converting a continuous curved surface into the quadrilateral mesh model, and carrying out mesh local encryption processing on local features of the valve frame surface.

Then, establishing a Riemann metric tensor component calculation model, expanding the three-dimensional curved surface into a two-dimensional plan view by combining the cutting paths, wherein the method comprises the steps of determining a minimum strain energy cutting path of the surface of the valve frame, establishing the Riemann metric tensor component calculation model, expanding the three-dimensional curved surface along the determined cutting path, and calculating the two-dimensional coordinates of the grid nodes by taking an expansion datum point as a starting point.

And finally, calculating the actual circumference of the valve frame, and determining the cutting size and the allowance of the cloth according to the number of wrapping layers. The method comprises the steps of calculating the actual circumference according to the target radius of the flap and the local curvature deviation, marking the dimension on a plan view, reserving an operation allowance, calculating the actual cutting dimension of cloth according to the wrapping layer number, and increasing the overlapping amount and the flanging allowance in the circumferential dimension and the vertical direction.

Specifically, for valve frame modeling, in one implementation scenario, a three-dimensional curved surface modeling method may be employed to construct a valve frame structure. The valve frame is regarded as a three-dimensional geometric body with a continuous conductive curved surface, and is described by using a Bessel curved surface equation. For any pointIts position vector is determined by the following equation: , wherein, In order to control the coordinates of the points,AndRespectively, the n-th and m-th order of the binstein basis function. By adjusting the control point positions, the curved surface meets the geometric feature requirements of the first valve frame 130. In actual operation, 16 control points are selected, four bezier curved surfaces are constructed, and the distance between the control points is kept between 2.15 and 2.35 millimeters.

And then carrying out surface discretization treatment to convert the continuous surface into a triangular mesh model. The quadrilateral mesh division scheme with the mesh size of 0.25-0.30 mm is adopted, so that the mesh density of the area with larger curvature change is ensured to be correspondingly improved. In the grid generation process, the size ratio of adjacent grid cells is not more than 1.08, so that grid distortion is avoided. For local features of the valve frame surface, such as the chamfer and transition area of the connecting part, local encryption treatment is adopted, and the mesh size is reduced to 0.15-0.18 mm.

The three-dimensional mesh model is then converted to a two-dimensional plan. First, a minimum strain energy cutting path of the valve frame surface is determined, wherein the path is obtained by minimizing the following energy functional: Wherein Gij and Gij are Riemann metric tensor components before and after deformation, αi is a weight coefficient, ij represents a row-column index of the control point, i ranges from 0 to n (n=4, four bezier surfaces), and j ranges from 0 to m (m=4, four bezier surfaces). Determining a cutting path through iterative calculation, and expanding the three-dimensional curved surface along the path. In the expansion process, for a standard of the nominal size of the first valve frame 130 of 19 mm, the expansion reference point coordinates are set to be (0, 0), and the two-dimensional coordinates of the grid nodes are calculated sequentially in the circumferential direction.

And determining the actual size according to the unfolded plan view. For different specifications of the valve frame width in the range of 19-31 mm, a parameterized model is established for size conversion. Taking the 19 mm specification as an example, the actual circumference L of the first valve leaflet 130 is calculated by the following correction formula: Wherein r is the nominal radius of the valve frame, In the event of a local curvature deviation,AndFor correction coefficients, values 0.0625 and 0.0278 were taken, respectively. And correspondingly adjusting correction coefficients for the valve frames with different specifications. Based on the calculation result, critical dimensions are marked on the plan view, and an operation margin of 4.0-4.5 mm is reserved.

After determining the planar unfolded size, the actual cut size of the cloth was calculated according to the three-layer wrap structure required by the ISO 5840 standard. The overlap between the wrapping layers is considered, and the overlap amount of 6.0-6.5 mm is additionally increased on the basis of the circumferential dimension. For the dimension in the vertical direction, the hemming margin of 8.5-9.0 mm is increased on the reference height. And precisely folding the cut cloth along a set folding line, determining the position of the folding line through laser positioning, and controlling the positioning precision within 0.05 mm. Finally, ironing and shaping is carried out under the condition that the temperature is constantly controlled at 121 ℃, and the ironing pressure is kept at 0.18-0.20 megapascals for 15-20 seconds.

Returning to the step of sewing the first flap frame 130, after the molding, the first flap frame 130 is unfolded into a plan view according to the width and circumference of the first flap frame 130, and the first flap frame is folded in half according to the number of wrapping layers, and then the marks are ironed. Preferably, in one embodiment, after the three-dimensional modeling of the first valve leaflet frame 130 is completed, a planar deployment is required according to its actual dimensional parameters. The primary parameters of the first valve frame 130 include the design width range of the nominal valve size 19-31 millimeters and the corresponding circumference. The number of wrapping layers is determined to be 3 according to the requirements of the ISO 5840 standard, and an operation allowance of 4.0-4.5 mm is reserved on the unfolded view. And folding the cut cloth in half, ironing at the temperature of 121 ℃ for 15-20 seconds to ensure that folds are clear. In this process, the doubling of the cloth must be accurate, and the deviation should not exceed 0.5 mm, to ensure accuracy of subsequent processing.

Fig. 7 is a schematic diagram of a sewn flap frame according to an embodiment of the present application, wherein a flap frame wrapping joint is sewn by a stitch sewing method using diagonal connection at both ends to avoid thread end accumulation, two triangular cloths are unfolded after sewing, the sewn part is unfolded by an iron, ironing is performed, and redundant parts are cut off. In one embodiment, a special diagonal joining process is used at the joints of the flap frame wrap 210, primarily to avoid pile-up of thread ends at the seams. The specific operation is that an inclined angle of 30 degrees is formed at two ends, and 6-0 specification suture is adopted for suture connection of the closing needle. The stitch length during stitching is controlled to be 2.5-3.0 mm, and the depth of each needle is kept to be 2.0-2.5 mm. After the sewing is completed, the two formed triangular cloth materials are unfolded, and the unfolding angle of the cloth materials is kept between 165 and 170 degrees, so that the seam is smooth and wrinkle-free. The sewn parts were twice ironed using a medical iron at 121C, each position was maintained for about 15-20 seconds, and then excess cloth was trimmed off using sterile surgical scissors, reserving a margin of 2.5-3.0 mm.

Ironing the joint again according to the marks, placing the first valve frame 130 in the valve frame wrapping cloth, sewing the two folded ends by adopting a needle return, and reserving the length of 1.5-2.0 mm between the valve frame wrapping cloth and the first valve frame 130, so that the valve leaflet 140 can be conveniently fixed for use later. In one embodiment, the cloth at the junction is folded again according to the previously ironed imprint. The first valve leaflet frame 130 was placed in the valve leaflet frame wrapper with care being taken to maintain a gap distance of 1 millimeter between the first valve leaflet frame 130 and the valve leaflet frame wrapper. The two ends of the suture are fixed after the suture is folded by adopting the suture with 5-0 specification, the distance between each needle is kept between 3.0 and 3.5 mm during the suture, and the suture depth is controlled within the range of 2.5 to 3.0 mm. Reinforcing stitching is added at the critical stress position, the stitch length of the reinforcing stitching should be kept between 2.0 and 2.5 mm, and the sewn valve frame 320 is shown in fig. 7.

A plurality of reserved holes are uniformly arranged on three sides of the leaflet 140 for threading when suturing.

At step S103, the hole at the midpoint of the three sides of the leaflet 140 is matched with the lowest position of the sewn second leaflet seat 310, and is continuously sewn to the top end of the second leaflet seat 310 from the midpoint of the three sides by uniformly distributing other hole positions preset on each side, and the suture is folded and sewn from the leaflet She Yuliu part 142 and then passed out of the suture wound leaflet seat wrapping cloth 220. The method comprises the steps of respectively matching the hole positions at the midpoint positions of three sides of the valve leaflet 140 with the lowest position of the second valve seat 310, penetrating out the suture from the hole positions at the midpoint positions of each side of the valve leaflet 140 and the matched valve seat wrapping cloth 220, sewing the valve leaflet 140 and the second valve seat 310 together by uniformly distributing other hole positions preset on each side of the valve leaflet 140 by utilizing the two ends of the suture until the two ends of each suture pass through the first hole positions 141 at the two ends of each side of the valve leaflet 140, respectively doubling the suture passing through the first hole positions 141 from the second hole positions 143 and the third hole positions 144 of the valve She Yuliu part 142 at the side adjacent to the first hole positions 141, and performing knotting on the encountered suture, respectively winding the knotted thread around the valve seat wrapping cloth 220 at the top end of the corresponding second valve seat 310 from the opposite direction, and penetrating out the corresponding vertex hole positions 145 of the valve leaflet 140.

Fig. 8 is a schematic diagram of sewing a leaflet and a leaflet seat according to an embodiment of the present application, referring to fig. 8, for fixing the leaflet 140 on a second leaflet seat 310 after sewing, specifically, using a wrapped leaflet seat, aligning the hole at the midpoint position of 3 leaflets 140 with the lowest position of the second leaflet seat 310 after sewing, threading the thread through the fixing positions through the punching positions after threading the thread out, continuously sewing the top end of the second leaflet seat 310 after sewing on both sides, and stopping the thread at the second hole for standby. In one embodiment, during the fixation of the leaflet 140, it is first necessary to align the lowest point of the three leaflets 140 with the lowest point of the sewn leaflet seat 310 using the sewn second leaflet seat 310. The positional deviation of each leaflet 140 should not exceed 0.5mm to ensure symmetry of the overall structure. Using a special cardiac surgical suture needle, 7-0 gauge suture is threaded from a preset perforation location, typically 4.0-4.5 mm above the bottom edge of the valve seat, with a suture length of about 120-150 mm reserved. The suture passing through the perforation location is continuously sewn toward the top ends of both sides of the sewn second flap seat 310 while maintaining the tension of the suture between 0.8-1.2 newtons until the second perforation location is reached, the suture is stopped and reserved.

The portion of the thread outside the second valve seat 310 left from the leaflet 140 is sewn from outside to inside, the left portion is folded in half inwardly and is threaded to the inside, and similarly, the two threads are threaded to the outside and three knots are tied. In one embodiment, in handling the outer suture of the second valve seat 310, an outside-in suture is required starting from the reserved portion of the leaflet 140. The suturing depth should be controlled between 2.0-2.5 mm, and the spacing between each needle should be kept between 2.5-3.0 mm. The reserved portion is folded inwardly, typically to a width of between 4.0 and 4.5 mm. The other two sutures were treated in the same manner to ensure that the operating parameters of both sides remained consistent. When two sutures meet at an intermediate location, it is necessary to tie five knots in succession using standard surgical knots, with the spacing between each knot maintained at 2.0 mm, which reveals sufficient structural strength.

The knotted thread is wrapped by the valve seat wrapping cloth in two opposite directions and is penetrated out from the vertex punching position. In one embodiment, the knotted suture is secured by wrapping around the valve seat wrap on both sides. The trend of the suture lines is parallel to the texture of the flap seat wrapping cloth, so that local stress concentration is avoided. Finally, the suture is penetrated out from the punching position of the vertex, and the angle of the suture during penetrating out is kept at 90 degrees, so that friction between the suture and the cloth can be reduced. A circular reinforcing area with the diameter of 4.0-4.5 mm is added near the passing-out point.

At step S104, the second sewn valve frame 320 and the second sewn valve seat 310 are combined, the suture line extends to the vertex of the second valve seat 310 through the hole positions at the middle points of the three sides of the valve leaflet 140, and the suture line is sewn alternately through the valve frame wrapping cloth 210, the reserved hole positions of the valve leaflet 140 and the valve seat wrapping cloth 220 in sequence until the vertex of the second valve seat 310 is knotted and fixed, so as to obtain the valve main body. The method comprises the steps of penetrating three equal-length sutures from the hole sites at the midpoint positions of three sides of the valve leaflet 140 respectively, sequentially penetrating the needle through the valve frame wrapping cloth 210, the reserved hole sites of the valve leaflet 140 and the valve seat wrapping cloth 220 to finish first needle sewing, starting from the second valve seat 310, performing second needle sewing through the valve leaflet 140 and the second valve frame 320, and repeating the sewing step until the sutures penetrate through the top points of the second valve seat 310 and are knotted and fixed to obtain the valve main body.

Fig. 9 is a schematic diagram of fixing a leaflet frame according to the present application, for fixing and sewing the leaflet 140, the second leaflet frame 320 after sewing, and the second leaflet seat 310 after sewing, referring to fig. 9, the lines at the three vertices may be penetrated upward from the vertices of the second leaflet seat 310 after sewing, three equal length lines are prepared, the second leaflet seat 310 after sewing is found, the leaflet 140, the three lowest points of the second leaflet frame 320 after sewing are penetrated from the perforation positions of the leaflet 140, and then the two sides are respectively perforated according to the leaflet 140, the sewing needle penetrates the leaflet from the leaflet frame, the first needle sewing is completed after the leaflet seat is wrapped with the cloth, and then the second needle sewing is completed by the second leaflet seat 310 through the leaflet 140, and the second leaflet frame 320 is wound and penetrated out, thereby reciprocating until the sewing to the vertices of the second leaflet seat 310 after sewing is completed, and knotting is completed. Preferably, after the stitch fixation at the three vertices is completed, the stitches need to be extended up to the sewn flap seat 310 vertices. Three 6-0 gauge sutures with lengths between 150 and 180 mm are prepared, and the lowest points of the leaflet 140, the second valve frame 320 after sewing and the second valve seat 310 after sewing are found. Starting from the perforation of the leaflet 140, the needle needs to pass through the second leaflet frame 320, the leaflet 140 and the second leaflet seat 310 in sequence, each needle having a depth of between 2.5 and 3.0 millimeters. After the first needle is completed, a second needle suture is performed through the leaflet 140 and the first frame 130 from the second valve seat 310, and so on, alternately until reaching the apex of the second valve seat 310 after the suture, and finally the valve body is obtained. During the suturing process, the tension of the suture should be maintained between 1.0 and 1.2 newtons, which ensures structural stability without affecting the flexibility of the valve. When knotting at the vertex, the diameter of the knot is controlled between 2.5 and 3.0 mm.

At step S105, the annulus 110 is sutured secured under the second valve seat 310 in the valve body to obtain a polymeric valve. The method comprises the steps of aligning short ends of an annuloplasty wrapping cloth 150, continuously sewing the annuloplasty wrapping cloth 150 into a ring shape, placing the annuloplasty 110 in the middle of the annuloplasty wrapping cloth 150, sewing the annuloplasty 110 into the annuloplasty wrapping cloth 150 by needle hiding, tightening the suture lines to form a wrapped felt annuloplasty, aligning the wrapped felt annuloplasty with the bottom of a second valve seat 310, sewing and fixing the suture lines through the felt annuloplasty and preformed holes of the second valve seat 310 by adopting a continuous sewing method, and adding reinforcing sewing in a high stress area to obtain the polymer valve. Fig. 10 is a schematic diagram of a process for wrapping an annulus and suturing the wrapped annulus to a valve body to obtain a polymeric valve according to an embodiment of the present application. In one implementation, the annulus 110 fixation may be performed by sewing the trimmed annulus 110 directly under the second valve seat 310 of the valve body according to the second valve seat 310 perforation, using a needle-back suture to fix the annulus 110. Preferably, the pre-prepared annulus 110 formed by cutting a medical grade felt is positioned according to the perforated position of the second valve seat 310, wherein the annulus 110 has a thickness of between 2.5-3.0 mm. As shown in fig. 10, the short ends of the annuloplasty wrap 150 are aligned and continuously sewn into a ring shape, the annulus 110 is placed in the middle of the annuloplasty wrap 150, the annulus 110 is sewn into the annulus wrap 150 by needle hiding, the stitches are tightened to form a wrapped felt annulus, the wrapped annulus 110 or the felt annulus is fixed under the second valve seat 310 by needle returning sewing with 5-0 specification stitches, the needle pitch during sewing is controlled to be 2.5-3.0 mm, and the depth is kept to be 2.0-2.5 mm. Care should be taken to maintain a uniform tension during suturing, typically between 0.8 and 1.0 newtons, so that localized deformation is avoided. Reinforcing stitching is added in the high stress area, and the stitch length of the reinforcing stitching is kept between 2.0 and 2.5 mm. After the fixation is completed, the entire annulus 110 needs to be checked in all directions in accordance with the ISO 5840 standard.

It should be understood that the structures shown in the drawings of the embodiments of the present application are illustrative and not limiting. It is intended that the structure referred to is not limited to a particular form or design, but is presented as an example. In other words, the structure shown in the drawings may be regarded as an expression for clearly describing the related concepts and relations, and not excluding other forms of structure. Therefore, in explaining the structure in the drawings, it should be understood that it is intended to disclose an exemplary description, not a restrictive definition of a particular form.

The embodiment of the application discloses a polymer valve applying the suture preparation method according to any one of the above embodiments, which comprises an annulus 110, a first valve seat 120, a first valve frame 130, valve leaflets 140, a valve frame wrapping cloth and a valve seat wrapping cloth, wherein the annulus 110 is arranged at the bottom of the valve, an annular structure is adopted, the upper surface of the annulus 110 is connected with the valve seat 120, the valve seat 120 is of an annular step-shaped structure, the inner side wall of the annulus 120 is provided with a groove for installing the valve leaflets 140, the outer peripheral wall of the annulus is matched with the annulus 110, the upper surface of the valve seat 120 is provided with a positioning structure matched with the valve frame 130, and the positioning structure comprises a plurality of bosses uniformly distributed along the circumferential direction of the valve seat 120. The valve frame 130 is composed of three struts, the lower ends of the struts are fixedly connected with the positioning structure on the valve seat 120, the upper ends of the struts are mutually connected to form a supporting structure, the valve blades 140 are made of high polymer materials and are in a sheet shape, and the edges of the valve blades are fixedly connected with the valve seat 120 and the valve frame 130 through suture lines. The valve frame wrapping cloth 210 covers the surface of the valve frame 130 and is fixed by a needle-back stitching mode, and the valve seat wrapping cloth 220 covers the outer surface of the valve seat 120 and is fixed by a needle-back stitching mode.

In one embodiment, the flap seat wrapping cloth is made by a special sewing process by folding the cut flap seat wrapping cloth in half to make the inner side edge slightly longer than the outer side edge by about 2mm, and then aligning the left and right ends and ironing to form folds. After the flap seat wrapping cloth is unfolded, the left end and the right end are sewn in a crisscross sewing mode to form a barrel-shaped structure. After the valve seat 120 is placed in the valve seat wrapping cloth, the valve seat 120 is fixed inside the valve seat wrapping cloth through a back needle sewing process, and the needle pitch of the sewing thread is kept between 1.5 and 2.5 millimeters. The redundant flap seat wrapping cloth is fixed on the surface of the original flap seat wrapping cloth in a continuous sewing mode after being folded. The installation of the flap frame wrapping cloth needs to consider the joint treatment, namely, a diagonal connection and butt joint backstitch sewing method is adopted at the joint, and after the sewing is completed, two triangular cloth materials are unfolded and ironed, so that the joint is ensured to be flat. When the leaflet frame 130 is placed in the leaflet frame wrapper, a gap of about 1 millimeter is maintained between the leaflet frame and the leaflet seat wrapper, which is designed to facilitate subsequent fixation of the leaflet 140.

In the mounting process of the leaflet 140, a positioning suture technique is adopted, namely, firstly, the lowest point of the three leaflets 140 is aligned with the lowest position of the valve seat 120, and the suture thread is penetrated out through a special positioning hole and is temporarily fixed. Subsequently, a continuous suture is applied along the top of both sides of the valve seat 120, and the suture is suspended and reserved at the second pilot hole. The left suture of the valve seat 120 needs to be sewn from left to right at the reserved part of the valve leaflet 140, the reserved part is folded inwards and then is penetrated out to the right, the right suture needs to be penetrated out to the left, and the two sutures are finally knotted and fixed. The suture after the fixation is wrapped by the wrapping cloth of the valve seat by the left side and the right side, and finally the suture passes through the positioning hole at the vertex. In the triple fixation of the leaflet 140, the leaflet frame 130 and the valve seat 120, three equal-length sutures are first prepared, the lowest points of the three members are found, and the sutures are threaded out from the positioning holes of the leaflet 140. The needle needs to sequentially pass through the valve frame 130, the valve leaflet 140 and the valve seat wrapping cloth according to a specific path to form a first suture, then pass through the valve leaflet 140 and the valve frame 130 from the valve seat 120, and pass out in a winding way to complete a second suture, and the steps are repeated until the suture is sewn at the top point of the valve frame 130 and knotted and fixed. Finally, the pre-cut annulus 110 is fixed below the valve seat 120 by a needle-back stitching mode through a positioning hole on the valve seat 120, and the whole valve is assembled.

Further, the embodiment of the application also discloses a three-dimensional modeling device of the valve frame, which comprises a processor, a memory and a system bus, wherein the processor and the memory are connected through the system bus, and the memory is used for storing one or more programs, and the one or more programs comprise instructions which when executed by the processor, cause the processor to execute any one of the methods.

Further, embodiments of the present application also disclose a computer program product which, when run on a terminal device, causes the terminal device to perform any of the methods described above.

From the above description of embodiments, it will be apparent to those skilled in the art that all or part of the steps of the above described example methods may be implemented in software plus necessary general purpose hardware platforms. Based on such understanding, the technical solution of the present application may be embodied essentially or in a part contributing to the prior art in the form of a software product, which may be stored in a storage medium, such as ROM/RAM, a magnetic disk, an optical disk, etc., including several instructions for causing a computer device (which may be a personal computer, a server, or a network communication device such as a media gateway, etc.) to execute the method described in the embodiments or some parts of the embodiments of the present application.

It should be noted that, in the present description, each embodiment is described in a progressive manner, and each embodiment is mainly described in a different manner from other embodiments, and identical and similar parts between the embodiments are all enough to refer to each other. For the device disclosed in the embodiment, since it corresponds to the method disclosed in the embodiment, the description is relatively simple, and the relevant points refer to the description of the method section.

It should also be noted that in embodiments of the present application, relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises an element.

The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present application. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined in the embodiments of the application may be applied to other embodiments without departing from the spirit or scope of the application. Thus, the present application is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A method for preparing a suture of a polymer valve, comprising:

Cutting, folding, ironing and shaping the flap seat wrapping cloth (220), and sewing the flap seat wrapping cloth into a cylinder by adopting cross stitching, placing the first flap seat (120) in the cylinder which is sewn and fixed by adopting a backstitch stitching, and continuously sewing and fixing the redundant part after the redundant part is folded so as to obtain a sewn second flap seat (310);

Manufacturing a valve frame wrapping cloth (210) according to a three-dimensional model unfolding diagram of the first valve frame (130), sewing and ironing a joint by adopting oblique line to a return needle, placing the first valve frame (130) in the joint, and sewing and fixing the return needle to obtain a second valve frame (320) after sewing;

the hole sites at the middle points of the three sides of the valve leaflet (140) are matched with the lowest part of the sewn second valve seat (310), the middle points of the three sides are continuously sewn to the top end of the second valve seat (310) through other hole sites which are uniformly distributed and preset on each side, and the suture thread wound valve seat wrapping cloth (220) is penetrated out after the valve She Yuliu part (142) is folded and sewn;

The sewn second valve frame (320) and the sewn second valve seat (310) are combined, a suture line extends to the vertex of the second valve seat (310) through the hole positions at the middle points of the three sides of the valve leaflet (140), and the suture line alternately sews through the valve frame wrapping cloth (210), the reserved hole positions of the valve leaflet (140) and the valve seat wrapping cloth (220) until the vertex of the second valve seat (310) is knotted and fixed, so that a valve main body is obtained;

an annulus (110) is sutured secured under a second valve seat (310) in the valve body to obtain a polymeric valve.

2. The sewing preparation method according to claim 1, wherein the flap seat wrapping cloth (220) is cut, folded, ironed and shaped, a cross stitch is adopted to form a cylinder, the first flap seat (120) is placed in the cylinder formed by the stitch, and is fixed by a backstitch stitch, and the redundant part is folded and continuously stitched and fixed to obtain a sewn second flap seat (310), comprising:

cutting the flap seat wrapping cloth (220) according to the three-dimensional shape characteristics of the first flap seat (120) so that one side edge of the flap seat wrapping cloth is longer than the other side edge of the flap seat wrapping cloth;

folding the flap seat wrapping cloth (220) in half, and ironing at the crease by adopting ironing equipment;

Opening the flap seat wrapping cloth (220), and sewing the left end and the right end of the flap seat wrapping cloth (220) into a cylindrical structure by adopting cross stitching;

The first valve seat (120) is put into a cylindrical valve seat wrapping cloth (220) and is fixed by adopting a back needle suture;

And rolling the redundant flap seat wrapping cloth (220) and adopting continuous stitching to fix the flap seat wrapping cloth (220) so as to obtain a stitched second flap seat (310).

3. The sewing preparation method according to claim 1, wherein the manufacturing of the flap frame wrapping cloth (210) according to the three-dimensional model development of the first flap frame (130), sewing the joint with the stitch back with oblique lines and ironing, placing the first flap frame (130) therein and stitch back and fixing the stitch back to obtain the sewn second flap frame (320), comprises:

establishing a three-dimensional curved surface model according to the width and the circumference of the first valve frame (130) and expanding the model into a plan view to manufacture a valve frame wrapping cloth (210);

folding the flap frame wrapping cloth (210) according to the wrapping layer number and ironing out marks;

the joint of the flap frame wrapping cloth (210) is sewn by adopting oblique line connection and a folding needle;

spreading the triangular cloth formed at the joint, ironing and flattening, and then cutting redundant parts;

ironing the joint again according to the imprint, placing the first petal holder (130) into a petal holder wrapper (210);

And (3) fixing the two folded ends by adopting a back stitch suture, so that a gap is reserved between the flap frame wrapping cloth (210) and the first flap frame (130) to obtain a second flap frame (320) after sewing.

4. The suture preparation method according to claim 1, wherein the hole sites at the midpoint positions of the three sides of the leaflet (140) are matched with the lowest part of the second leaflet seat (310) after sewing, the hole sites are continuously sutured to the top end of the second leaflet seat (310) from the midpoint positions of the three sides by uniformly distributing other hole sites preset on each side, and the suture is wound around the leaflet seat wrapping cloth (220) after the leaflet She Yuliu is folded and sutured in half from the leaflet part (142), and the suture preparation method comprises the steps of:

respectively closing the hole sites at the middle points of the three sides of the valve leaflet (140) with the lowest part of the second valve seat (310);

A suture thread is penetrated from a hole site at the midpoint position of each side of the valve leaflet (140) and a folded valve seat wrapping cloth (220), and the two ends of the suture thread are utilized to suture the valve leaflet (140) and the second valve seat (310) together through other hole sites which are uniformly distributed and preset on each side of the valve leaflet (140) until the two ends of each suture thread pass through the first hole sites (141) at the two ends of each side of the valve leaflet (140);

Respectively doubling the suture passing through the first hole site (141) out of the second hole site (143) and the third hole site (144) of the valve She Yuliu part (142) on the adjacent side of the first hole site (141), and knotting the encountered suture;

And respectively winding the knotted wires around the valve seat wrapping cloth (220) at the top end of the corresponding second valve seat (310) from opposite directions, and penetrating out from the vertex hole sites (145) corresponding to the valve leaflets (140).

5. The sewing preparation method according to claim 1, wherein the sewing of the second valve frame (320) and the second valve seat (310) after sewing are performed, the sewing thread extends to the vertex of the second valve seat (310) through the hole positions at the middle points of the three sides of the valve leaflet (140), and the sewing is performed alternately by sequentially passing through the valve frame wrapping cloth (210), the reserved hole positions of the valve leaflet (140), and the valve seat wrapping cloth (220) until the vertex of the second valve seat (310) is knotted and fixed, and the method comprises:

three equal-length sutures are respectively penetrated out from the hole sites at the midpoint positions of three sides of the valve leaflet (140);

The stitching needle sequentially passes through the valve frame wrapping cloth (210), the reserved hole site of the valve leaflet (140) and the valve seat wrapping cloth (220) to finish the first stitching;

performing a second needle stitch through the leaflet (140) and the second leaflet frame (320) starting from the second leaflet seat (310);

The suturing step is repeated until the suture passes through the apex of the second valve seat (310) and is secured by knotting.

6. The sewing preparation method according to claim 1, wherein the sewing of the annulus (110) under the second valve seat (310) in the valve body to obtain the polymer valve comprises aligning the short ends of the annulus wrapping cloth (150), continuously sewing into a ring shape, placing the annulus (110) in the middle of the annulus wrapping cloth (150), sewing the annulus (110) into the annulus wrapping cloth (150) by needle hiding method, tightening the suture, forming a wrapped felt annulus;

and continuously threading a suture thread through the felt annulus and a reserved hole of the second valve seat (310) to suture and fix the felt annulus and the second valve seat (310) by adopting a continuous suture method.

7. The suture preparation method of claim 3, wherein creating a three-dimensional curved surface model from the first valve frame width and circumference and expanding into a plan view to produce the valve frame wrap comprises:

establishing a valve frame three-dimensional geometrical body through control point coordinates and a Bernstein basis function, and converting the valve frame three-dimensional geometrical body into a quadrilateral mesh model;

establishing a Riemann metric tensor component calculation model, and expanding the three-dimensional curved surface into a two-dimensional plan view by combining a cutting path;

Calculating the actual circumference of the valve frame, and determining the cutting size and the allowance of the cloth according to the number of wrapping layers.

8. The suture preparation method of claim 7, wherein creating a valve frame three-dimensional geometry by controlling point coordinates and a bernstein basis function and converting it into a quadrilateral mesh model comprises:

constructing a continuously-conductive valve frame three-dimensional geometrical body by adopting a Bessel curved surface equation;

calculating the position vector of any point through the control point coordinates and the Bernstein basis function;

Converting the continuous curved surface into a quadrilateral mesh model;

and carrying out grid local encryption processing on the local features of the surface of the valve frame.

9. The stitch preparation method as recited in claim 7, wherein creating a Riemann metric tensor component computation model, in combination with the cut path, expands the three-dimensional surface into a two-dimensional plan view, comprises:

Determining a minimum strain energy cutting path for the valve frame surface;

Establishing a Riemann metric tensor component calculation model;

Unfolding the three-dimensional curved surface along the determined cutting path;

two-dimensional coordinates of the mesh nodes are calculated with the expansion reference points as starting points.

10. The macromolecule valve applying the suturing preparation method according to any one of claims 1-9 is characterized by comprising an annulus (110), a first valve seat (120), a first valve frame (130), valve leaves (140), valve frame wrapping cloth (210) and valve seat wrapping cloth (220), wherein the annulus (110) is arranged at the bottom of the valve, an annular structure is adopted, the upper surface of the annulus is connected with the first valve seat (120), the first valve seat (120) is of an annular step-shaped structure, the outer peripheral wall of the bottom is matched with the annulus (110), the upper surface of the first valve seat (120) is provided with a positioning structure matched with the first valve frame (130), the first valve frame (130) is composed of three struts, the lower ends of the struts are fixedly connected with the positioning structure on the first valve seat (120), the upper ends of the struts are mutually connected to form a supporting structure, the valve leaves (140) are made of macromolecule materials, the edges of the annulus are reserved with a plurality of holes and are fixedly connected with the first valve seat (120) and the first valve frame (130) through sutures, the upper surface of the annulus is fixedly connected with the first valve seat (120), the valve frame (210) through sutures, and the needle wrapping cloth (220) is fixedly covered on the outer surface of the first valve seat (120) through the suture needle wrapping needle.