Suture preparation method of polymer valve and related product

Abstract

The invention discloses a suturing preparation method of a polymer valve and a related product, and belongs to the technical field of heart valves.The method comprises the steps that hole sites in the midpoint positions of the three edges of a valve leaflet and the low position of a sewn second valve seat are folded, the valve leaflet is continuously sutured to the second valve seat part through the punching positions, and the valve leaflet is obtained; after the folded reserved part is sewn, a sewing thread is wound around the valve seat wrapping cloth and penetrates out; folding the sewn second valve frame and the sewn second valve seat, extending three hole site stitches to the vertex of the second valve seat, alternately sewing the stitches through the valve frame wrapping cloth, the valve leaflet reserved hole sites and the valve seat wrapping cloth in sequence until the vertex of the second valve seat is reached, and knotting and fixing to obtain a valve main body; and fixing the valve below a second valve seat in the valve main body in a looping manner to obtain the polymer valve. According to the scheme, the valve sewing precision can be improved, and the structural strength of the reinforced sewing area is enhanced.

Description

Technical Field

[0001] The present application relates to the field of heart valves, and in particular to a suturing preparation method of a polymer valve and related products. Background Art

[0002] Artificial heart valve replacement surgery is an important means of treating heart valve disease, and the choice of artificial 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, artificial heart valves mainly include two categories: mechanical valves and biological valves. Both types of valves show their own technical limitations in clinical applications. Mechanical valves are made of artificial materials such as titanium alloys and pyrolytic carbon, and their leaflet opening and closing mechanisms usually include a variety of structural forms such as single leaflets, double leaflets or ball cages. Since mechanical valves have excellent mechanical properties and durability, their theoretical service life can reach more than 20 years. However, the key technical defect of mechanical valves is that the blood compatibility of the surface of their artificial materials is poor, which easily induces platelet aggregation and coagulation factor activation, resulting in a significantly increased risk of thrombosis. In order to prevent thromboembolic complications, patients who undergo mechanical valve replacement must take anticoagulants such as warfarin for life, which not only increases the risk of bleeding, but also brings a large medication burden and inconvenience to patients. Bioprosthetic valves use specially treated xenogeneic pericardium (such as bovine pericardium, porcine pericardium) or autologous tissue to make valve leaflets. Their tissue structure is similar to the natural valves of the human body and has good blood compatibility. Patients usually do not need long-term anticoagulation. However, the main technical difficulty of bioprosthetic valves is their lack of durability. After implantation in the body, they are prone to calcification and tissue degeneration, and often require reoperation within 10-15 years. In addition, the preparation process of existing bioprosthetic valves is complex, quality control is difficult, and the production cost is high, which also restricts their further promotion and use.

[0003] In recent years, researchers have disclosed new artificial heart valve technology routes based on polymer materials in response to the inherent defects of mechanical valves and biological valves. Polymer valves try to achieve a balance between durability and blood compatibility by selecting synthetic materials with specific mechanical properties and biocompatibility, such as polyurethane and polycarbonate, and using precision processing technology to make leaflet structures. The leaflet materials of this type of valve can be optimized through molecular design and surface modification technology, and in theory, mechanical properties and blood compatibility close to those of natural valves can be obtained. At present, researchers have developed a variety of improved polymer valves, including the use of nanocomposites to enhance leaflet degree, the use of surface patterning technology to improve anti-thrombotic properties, and the introduction of bioactive molecules to promote endothelialization. However, the actual performance of polymer valves depends largely on the accuracy and controllability of their manufacturing process. Especially at the connection between the leaflet and the stent, the current manual sewing method has problems such as insufficient operating accuracy and uneven connection strength, which easily forms stress concentration areas and leads to early damage to the leaflet. At the same time, polymer materials may experience aging phenomena such as fatigue damage and stress relaxation under long-term cyclic loads, and their durability evaluation and prediction still face challenges.

[0004] Therefore, there is an urgent need for a technical solution that can improve the valve sewing accuracy and enhance the structural strength of the reinforced suture area. Summary of the invention

[0005] In order to solve the deficiencies of the prior art, the present application discloses a method for preparing a polymer valve by suturing and related products. The present application solves the technical problems of the prior art such as uneven connection strength and easy formation of stress concentration areas.

[0006] The embodiment of the present application discloses a method for suturing and preparing a polymer valve, comprising: cutting a valve seat wrapping cloth, folding it in half and ironing it to shape, cross-stitching it into a tube, placing a first valve seat in the sewed tube and fixing it with back stitching, folding the excess part and continuously stitching it to obtain a sewn second valve seat; making a valve frame wrapping cloth according to the unfolded three-dimensional model of the first valve frame, aligning the connection with back stitching with an oblique line and ironing it, placing the first valve frame in it and back stitching it to obtain a sewn second valve frame; aligning the hole positions at the midpoints of the three sides of the valve leaflet with the second valve frame after sewing The lowest part of the seat is aligned, and the sutures are continuously sutured from the midpoints of the three sides through other holes evenly preset on each side to the top of the second valve seat. After folding and suturing the reserved part of the leaflet, the sutures are wrapped around the valve seat wrapping cloth and passed out; the sewn second valve frame and the sewn second valve seat are aligned, and the sutures are extended to the apex of the second valve seat through the holes at the midpoints of the three sides of the leaflet, and alternately sutured through the valve frame wrapping cloth, the reserved holes of the leaflet, and the valve seat wrapping cloth until the apex of the second valve seat is reached and knotted to obtain the valve body; the valve ring is sutured and fixed below the second valve seat in the valve body to obtain a polymer valve. In a possible implementation, the petal seat wrapping cloth is cut, folded in half, and ironed to shape, cross-stitched to form a tube, the first petal seat is placed in the sewn tube and fixed by back stitching, and the excess part is folded and continuously stitched to obtain a sewn second petal seat, including: cutting the petal seat wrapping cloth according to the three-dimensional shape characteristics of the first petal seat so that one edge of the petal seat is longer than the other edge; folding the petal seat wrapping cloth in half and ironing the crease with an ironing device; opening the petal seat wrapping cloth and cross-stitching the left and right ends of the petal seat wrapping cloth to form a tube-shaped structure; placing the first petal seat in the tube-shaped petal seat wrapping cloth and fixing it by back stitching; folding the excess petal seat wrapping cloth and fixing it to the petal seat wrapping cloth by continuous stitching to obtain a sewn second petal seat.

[0007] In a possible implementation, a petal frame wrapping cloth is made according to the unfolded view of the three-dimensional model of the first petal frame, the connection points are sewn with diagonal lines and ironed, the first petal frame is placed therein and fixed with back stitches to obtain a sewn second petal frame, including: establishing a three-dimensional surface model according to the width and circumference of the first petal frame and unfolding it into a plane view to make the petal frame wrapping cloth; folding the petal frame wrapping cloth in half according to the number of wrapping layers and ironing out marks; using diagonal lines to connect and back stitch at the joints of the petal frame wrapping cloth; unfolding the triangular cloth formed at the joints, ironing it flat and then cutting off the excess parts; ironing the connection points again according to the marks, and placing the first petal frame into the petal frame wrapping cloth; and fixing the two folded ends with back stitches to leave a gap between the petal frame wrapping cloth and the first petal frame to obtain a sewn second petal frame.

[0008] In a possible implementation method, the holes at the midpoints of the three sides of the leaflet are aligned with the lowest point of the sewn second petal seat, and the three sides are continuously sutured to the top of the second petal seat through other holes uniformly preset on each side, and the sutures are wrapped around the petal seat wrapping cloth after the reserved part of the leaflet is folded in half and sutured, including: aligning the holes at the midpoints of the three sides of the leaflet with the lowest point of the second petal seat respectively; passing the sutures from the holes at the midpoints of each side of the leaflet and the aligned petal seat wrapping cloth, and using Use the two ends of the suture to pass through other holes evenly preset on each side of the leaflet, and sew the leaflet and the second leaflet seat together until the two ends of each suture pass through the first hole at both ends of each side of the leaflet; fold the suture that passes through the first hole and pass it through the second and third holes of the reserved part of the leaflet on the side adjacent to the first hole, and tie a knot when the sutures meet; wrap the knotted threads around the corresponding leaflet seat wrapping cloth at the top of the second leaflet seat from opposite directions, and pass it through the corresponding vertex hole of the leaflet.

[0009] In a possible implementation, the sewn second valve frame is aligned with the sewn second valve seat, and the suture is extended to the apex of the second valve seat through the holes at the midpoints of the three sides of the leaflet, and is alternately sutured through the valve frame wrapping cloth, the reserved holes of the leaflet, and the valve seat wrapping cloth in sequence until the apex of the second valve seat is reached and knotted and fixed, including: three sutures of equal length are respectively passed through the holes at the midpoints of the three sides of the leaflet; the suture needle passes through the valve frame wrapping cloth, the reserved holes of the leaflet, and the valve seat wrapping cloth in sequence to complete the first stitch; the second stitch is performed starting from the second valve seat through the leaflet and the second valve frame; the suturing steps are repeated until the suture passes through the apex of the second valve seat and is knotted and fixed.

[0010] In a possible implementation, the valve ring is sutured and fixed below the second valve seat in the valve body to obtain a polymer valve, including: aligning the short ends of the valve ring wrapping cloth and continuously sewed into a ring shape, placing the valve ring in the middle of the valve ring wrapping cloth, sewing the valve ring into the valve ring wrapping cloth using the needle hiding method, tightening the sutures to form a wrapped felt valve ring; aligning the wrapped felt valve ring with the bottom of the second valve seat; and using the continuous suturing method to continuously pass the sutures through the reserved holes of the felt valve ring and the second valve seat for suturing and fixing.

[0011] In a possible implementation, a three-dimensional surface model is established according to the width and circumference of the first petal frame and unfolded into a plane graph to produce a petal frame wrapping cloth, including: establishing a three-dimensional geometric body of the petal frame through control point coordinates and Bernstein basis functions, and converting it into a quadrilateral mesh model; establishing a Riemann metric tensor component calculation model, and unfolding the three-dimensional surface into a two-dimensional plane graph in combination with the cutting path; calculating the actual circumference of the petal frame, and determining the cutting size and margin of the cloth according to the number of wrapping layers.

[0012] In one possible implementation, a three-dimensional geometric body of the valve frame is established through control point coordinates and Bernstein basis functions, and converted into a quadrilateral mesh model, including: using Bezier surface equations to construct a continuous and differentiable three-dimensional geometric body of the valve frame; calculating the position vector of any point through control point coordinates and Bernstein basis functions; converting the continuous surface into a quadrilateral mesh model; and locally encrypting the mesh of local features on the surface of the valve frame.

[0013] In one possible implementation, a Riemann metric tensor component calculation model is established, and the three-dimensional surface is unfolded into a two-dimensional plane diagram in combination with the cutting path, including: determining the minimum strain energy cutting path of the valve frame surface; establishing a Riemann metric tensor component calculation model; unfolding the three-dimensional surface along the determined cutting path; and calculating the two-dimensional coordinates of the grid nodes with the unfolding reference point as the starting point.

[0014] The embodiments of the present application also disclose a polymer valve using the suturing preparation method as described in any of the above embodiments, including: a valve ring, a first valve seat, a first valve frame, valve leaflets, and a valve frame wrapping cloth and a valve seat wrapping cloth; the valve ring is arranged at the bottom of the valve, adopts an annular structure, and its upper surface is connected to the first valve seat; the first valve seat is an annular step-shaped structure, and the bottom outer peripheral wall cooperates with the valve ring; the upper surface of the first valve seat is provided with a positioning structure that cooperates with the first valve frame, and the first valve frame is composed of three pillars, the lower ends of the pillars are fixedly connected to the positioning structure on the first valve seat, and the upper ends are connected to each other to form a supporting structure; the valve leaflets are made of polymer material, in the form of thin sheets, and a plurality of holes are reserved on the edges, which are fixedly connected to the first valve seat and the first valve frame by sutures; the valve frame wrapping cloth covers the surface of the first valve frame and is fixed by back-stitching; the valve seat wrapping cloth is covered on the outer surface of the first valve seat and is fixed by back-stitching.

[0015] In the suture preparation method and related products of a polymer valve disclosed above, the embodiments of the present application achieve more precise structural control by introducing a multi-layer three-dimensional wrapping structure and a special suturing process, which can improve the valve sewing accuracy and enhance the structural strength of the reinforced suture area. Further, in some embodiments, by setting a size difference between the inner and outer sides and combining a special tension-free cross-stitching process, the smoothness of the wrapping structure on a microscopic scale is ensured, and the optimal balance between structural stability and material stress distribution is achieved. Further, in some embodiments, through a three-point positioning and progressive suturing scheme, that is, by setting a specific punching position above the bottom edge of the valve seat, combined with precise tension control, the structural stability of the leaflet during fixation is ensured. In particular, at the vertex connection, a bidirectional cross-stitching technology is used, and uniform stress distribution is achieved by controlling the suturing depth and uniform needle spacing. This process not only improves the structural strength, but more importantly, it avoids the common local deformation problem in traditional processes through tension control. Furthermore, in some embodiments, the problem of thread accumulation at the seams in the traditional process is effectively solved by using a diagonal line connection method of backstitching, setting a suitable inclination angle, and using special-specification sutures for backstitching. Combined with the ironing process under specific temperature conditions, the flatness of the seams is ensured, and the mechanical properties of the overall structure are improved by reserving appropriate operating margins. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0017] Figure 1 A schematic diagram of a process for preparing a polymer valve suture disclosed in an embodiment of the present application; Figure 2 A schematic diagram of a valve component disclosed in an embodiment of the present application; Figure 3 A schematic diagram of another valve component disclosed in an embodiment of the present application; Figure 4 A schematic diagram of a petal seat wrapping cloth folded in half disclosed in an embodiment of the present application; Figure 5 This is a schematic diagram of aligning a petal seat wrapping cloth disclosed in an embodiment of the present application; Figure 6 A schematic diagram of a sewn petal seat disclosed in an embodiment of the present application; Figure 7 A schematic diagram of a sewn valve frame disclosed in an embodiment of the present application; Figure 8 A schematic diagram of sewing a valve leaflet and a valve seat disclosed in an embodiment of the present application; Fig. 9 A schematic diagram of a valve frame fixation disclosed in an embodiment of the present application; Fig.10 This is a schematic diagram of the process of wrapping a valve ring and suturing the wrapped valve ring to the valve body to obtain a polymer valve disclosed in an embodiment of the present application.

[0018] Explanation of the reference numerals: 110, valve ring; 120, first valve seat; 130, first valve frame; 140, valve leaf; 141, first hole position; 142, valve leaf reserved portion; 143, second hole position; 144, third hole position; 145, apex hole position; 150, valve ring wrapping cloth; 210, valve frame wrapping cloth; 220, valve seat wrapping cloth; 221, valve seat wrapping cloth fold; 222, valve seat wrapping cloth suture line; 310, second valve seat; 320, second valve frame. DETAILED DESCRIPTION

[0019] 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 components and steps, numerical expressions and numerical values ​​set forth in these embodiments do not limit the scope of the present disclosure unless otherwise specifically stated.

[0020] Those skilled in the art can understand that the terms "first", "second" and the like in the embodiments of the present disclosure are only used to distinguish different steps, devices or modules, etc., and neither represent any specific technical meaning nor represent the necessary logical order between them. It should also be understood that in the embodiments of the present disclosure, "multiple" can refer to two or more, and "at least one" can refer to one, two or more. It should also be understood that for any component, data or structure mentioned in the embodiments of the present disclosure, in the absence of explicit limitation or contrary revelation given in the context, it can generally be understood as one or more. In addition, the term "and / or" in the present disclosure is only a description of the association relationship of the associated objects, indicating that there can be three relationships, for example, A and / or B can represent: A exists alone, A and B exist at the same time, and B exists alone. In addition, the character " / " in the present disclosure generally indicates that the associated objects before and after are an "or" relationship. It should also be understood that the description of each embodiment in the present disclosure emphasizes the differences between the embodiments, and the same or similar parts can refer to each other. For the sake of brevity, they will not be repeated one by one.

[0021] At the same time, it should be understood that, for ease of description, the sizes of the various parts shown in the drawings are not drawn according to the actual proportional relationship. The following description of at least one exemplary embodiment is actually only illustrative and is by no means intended to limit the present disclosure and its application or use. The techniques, methods and devices known to ordinary technicians in the relevant fields may not be discussed in detail, but where appropriate, the techniques, methods and devices should be considered part of the specification. It should be noted that similar numbers and letters represent similar items in the following drawings, so once an item is defined in one drawing, it does not need to be further discussed in subsequent drawings.

[0022] In order to make the purpose, technical solution and advantages of the embodiments of the present application clearer, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0023] Figure 1 A schematic flow chart of a method for suturing and preparing a polymer valve disclosed in an embodiment of the present application.

[0024] It should be understood that the polymer valve is a new type of valve, between the biological valve and the mechanical valve. It is a new type of valve, and its main components refer to Figure 2 and Figure 3 , Figure 2 is a schematic diagram of a three-dimensional structure of a valve component disclosed in an embodiment of the present application, Figure 3 This is another schematic diagram of a valve component disclosed in an embodiment of the present application. Specifically, the valve components may include: a valve ring 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. Among them, the valve leaflet 140 is made of a polymer material. Therefore, in addition to material selection, the sewing method is particularly critical to sewing a high-quality valve.

[0025] like Figure 1As shown, in step S101, the petal seat wrapping cloth 220 is cut, folded in half, and ironed to shape, and cross-stitched to form a tube, the first petal seat 120 is placed in the sewn tube, and fixed by back stitching, and the excess part is rolled up and fixed by continuous stitching to obtain the sewn second petal seat 310. The process includes: cutting the petal seat wrapping cloth 220 according to the three-dimensional shape characteristics of the first petal seat 120 so that one side edge is longer than the other side edge; folding the petal seat wrapping cloth in half and ironing it at the fold using an ironing device; opening the petal seat wrapping cloth, and cross-stitching the left and right ends of the petal seat wrapping cloth into a tube structure; placing the first petal seat 120 in the tube-shaped petal seat wrapping cloth, and fixing it by back stitching; rolling up the excess petal seat wrapping cloth, and fixing it on the petal seat wrapping cloth 220 by continuous stitching to obtain the sewn second petal seat 310.

[0026] For sewing and wrapping the petal seat 120, in one embodiment, a petal seat wrapping cloth of a corresponding size is cut according to the shape of the first petal seat 120, and the cut petal seat wrapping cloth is first folded in half, such as Figure 3 As shown, the inner side and the outer side are bounded by the fold 221 of the petal seat wrapping cloth 220, and the inner side is longer than the outer side.

[0027] Figure 4 This is a schematic diagram of folding a petal seat wrapping cloth disclosed in an embodiment of the present application. Figure 5 This is a schematic diagram of aligning a petal seat wrapping cloth disclosed in an embodiment of the present application. Figure 6 This is a schematic diagram of a sewn petal seat disclosed in an embodiment of the present application. Figure 4 , align the left and right ends of the folded petal seat wrapping cloth 220 and iron them to make a mark, and then refer to Figure 5 After the petal seat wrapping cloth is opened, the left and right ends are aligned and cross-stitched to obtain the petal seat wrapping cloth suture line 222, and the petal seat wrapping cloth is sewn into a barrel shape, the petal seat 120 is placed at the fold 221 in the petal seat wrapping cloth, and then the petal seat is wrapped along the fold 221, and the petal seat 120 is fixed in the petal seat wrapping cloth by back stitching, and then the excess petal seat wrapping cloth is rolled up, and then the petal seat wrapping cloth is folded. Figure 6 , and continuously sewed onto the petal seat wrapping cloth 220 to obtain the sewn petal seat 310.

[0028] Preferably, the petal seat wrapping cloth of corresponding size is cut according to the three-dimensional shape characteristics of the first petal seat 120. In actual operation, the inner edge of the petal seat wrapping cloth should be about 4.5-5.0 mm longer than the outer edge. This size difference ensures smoothness after wrapping. Fold the cut petal seat wrapping cloth in half, and use a medical ironing device to iron along the crease for about 15-20 seconds at a temperature of about 121°C to form a positioning mark. Unfold the petal seat wrapping cloth, ensure that the left and right ends are aligned, and then use a tension-free cross-stitching process to sew the cloth into a tubular structure. When suturing, the stitch length is maintained between 3.0-3.5 mm, and the suture is 2.5-3.0 mm away from the edge of the cloth. Place the first petal seat 120 at the fold 221 of the tubular petal seat wrapping cloth, and use 5-0 non-damaging sutures to fix it with back stitches. After fixation, fold the excess petal seat wrapping cloth inwards, and the folding width is usually controlled between 5.0-5.5 mm. Finally, fix the folded edge to the petal seat wrapping cloth 220 with continuous suturing.

[0029] At step S102, a petal frame wrapping cloth is made according to the unfolded view of the three-dimensional model of the first petal frame 130, and the connection is sutured by back stitching with an oblique line and ironed, and the first petal frame 130 is placed in the petal frame wrapping cloth and fixed by back stitching to obtain the sewn second petal frame 320. This includes: establishing a three-dimensional curved surface model according to the width and perimeter of the first petal frame 130 and unfolding it into a plane view to make the petal frame wrapping cloth; folding the petal frame wrapping cloth in half according to the number of wrapping layers and ironing out marks; using oblique lines to connect and suture back stitching at the joint of the petal frame wrapping cloth 210; unfolding the triangular cloth formed at the joint and ironing it flat, and then cutting off the excess part; ironing the connection again according to the mark, and placing the first petal frame 130 in the petal frame wrapping cloth; and fixing the two ends after folding in half by back stitching, so that there is a gap between the petal frame wrapping cloth and the first petal frame 130, so as to obtain the sewn second petal frame 320.

[0030] Furthermore, a three-dimensional curved surface model is established according to the width and perimeter of the first petal frame 130 and unfolded into a plane view to produce a petal frame wrapping cloth, including: Firstly, the three-dimensional geometry of the valve frame is established through the control point coordinates and Bernstein basis functions, and then converted into a quadrilateral mesh model; this includes: constructing a continuous and differentiable three-dimensional geometry of the valve frame using Bezier surface equations; calculating the position vector of any point through the control point coordinates and Bernstein basis functions; converting the continuous surface into a quadrilateral mesh model; and locally encrypting the mesh of the local features of the valve frame surface.

[0031] Then, a Riemann metric tensor component calculation model is established, and the three-dimensional surface is unfolded into a two-dimensional plane diagram in combination with the cutting path; this includes: determining the minimum strain energy cutting path of the valve frame surface; establishing a Riemann metric tensor component calculation model; unfolding the three-dimensional surface along the determined cutting path; and calculating the two-dimensional coordinates of the grid nodes with the unfolding reference point as the starting point.

[0032] Finally, the actual perimeter of the flap frame is calculated, and the cutting size and margin of the fabric are determined according to the number of wrapping layers. This includes: calculating the actual perimeter based on the flap target radius and local curvature deviation; marking the dimensions on the plane and reserving operating margins; calculating the actual cutting size of the fabric based on the number of wrapping layers; and adding overlap and folding margins in the circumferential dimension and vertical direction.

[0033] Specifically, for valve frame modeling, in one implementation scenario, a three-dimensional surface modeling method can be used to construct the valve frame structure. The valve frame is regarded as a three-dimensional geometric body with a continuous and guidable surface, and is described using the Bezier surface equation. , whose position vector is determined by the following equation: ,in, are the control point coordinates, and They are nth and mth Bernstein basis functions respectively. By adjusting the position of the control points, the surface meets the geometric feature requirements of the first petal frame 130. In actual operation, 16 control points are selected to construct a quartic Bezier surface, and the control point spacing is maintained between 2.15-2.35 mm.

[0034] The surface was then discretized to convert the continuous surface into a triangular mesh model. A quadrilateral meshing scheme with a mesh size of 0.25-0.30 mm was used to ensure that the mesh density in areas with large curvature changes was increased accordingly. During the mesh generation process, the size ratio of adjacent mesh units did not exceed 1.08 to avoid mesh distortion. For local features on the surface of the valve frame, such as chamfers and transition areas at the connection, local encryption was used to reduce the mesh size to 0.15-0.18 mm.

[0035] Then the 3D mesh model is converted into a 2D plane. First, the minimum strain energy cutting path of the valve frame surface is determined, which is obtained by minimizing the following energy functional: , where gij and Gij are the Riemann metric tensor components before and after deformation, αi is the weight coefficient, ij represents the row and column index of the control point, i ranges from 0 to n (n=4, quartic Bezier surface), j ranges from 0 to m (m=4, quartic Bezier surface). The cutting path is determined by iterative calculation, and the three-dimensional surface is unfolded along the path. During the unfolding process, for the first petal frame 130 with a nominal size of 19 mm, the coordinates of the unfolding reference point are set to (0,0), and the two-dimensional coordinates of the grid nodes are calculated in sequence along the circumference.

[0036] The actual size is determined based on the unfolded plan view. For different specifications of the petal frame width within the range of 19-31 mm, a parametric model is established for size conversion. Taking the 19 mm specification as an example, the actual circumference L of the first petal frame 130 is calculated by the following correction formula: , where r is the nominal radius of the valve frame, is the local curvature deviation, and is the correction coefficient, which is 0.0625 and 0.0278 respectively. For valve frames of different specifications, the correction coefficient is adjusted accordingly. Based on the calculation results, the key dimensions are marked on the plan view, and an operating margin of 4.0-4.5 mm is reserved.

[0037] After determining the plane unfolding size, calculate the actual cutting size of the fabric according to the three-layer wrapping structure required by ISO 5840 standard. Considering the overlapping area between the wrapping layers, add an additional 6.0-6.5 mm overlap on the basis of the circumferential size. For the vertical dimension, add 8.5-9.0 mm folding allowance on the base height. The cut fabric is precisely folded along the set folding line. The position of the folding line is determined by laser positioning, and the positioning accuracy is controlled within 0.05 mm. Finally, ironing is performed under the condition of constant temperature control at 121°C, and the ironing pressure is maintained at 0.18-0.20 MPa for 15-20 seconds.

[0038] Returning to the step of sewing the first petal frame 130, after modeling, the first petal frame 130 is unfolded into a plane diagram according to its width and circumference, and then folded in half according to the number of wrapping layers and ironed to produce a mark. Preferably, in one embodiment, after completing the three-dimensional modeling of the first petal frame 130, it is necessary to carry out a plane unfolding according to its actual size parameters. The main parameters of the first petal frame 130 include the design width range of the nominal valve size of 19-31 mm and the corresponding circumference. According to the requirements of the ISO 5840 standard, the number of wrapping layers is determined to be 3 layers, and an operating margin of 4.0-4.5 mm is reserved on the unfolded diagram. The cut fabric is folded in half and ironed at a temperature controlled at 121°C for 15-20 seconds to ensure that the creases are clear. In this process, the fabric must be folded accurately, and the deviation should not exceed 0.5 mm to ensure the accuracy of subsequent processing.

[0039] Figure 7 The schematic diagram of a sewn petal frame disclosed in an embodiment of the present application is a method of sewing the petal frame wrapping joint with a back stitch sewed by connecting the two ends with an oblique line to avoid thread accumulation. After suturing, the two triangular cloths are unfolded, the seams are unfolded with an iron, ironed, and the excess parts are cut off. In one embodiment, a special oblique line connection process is used at the joint of the petal frame wrapping cloth 210, mainly to avoid thread accumulation at the seams. The specific operation is to form an inclination angle of 30 degrees at both ends, and use a 6-0 specification suture to perform back stitch suturing connection. The stitch length during suturing is controlled between 2.5-3.0 mm, and the depth of each stitch is maintained at 2.0-2.5 mm. After the suturing is completed, the two triangular cloths formed are unfolded, and the unfolding angle of the cloth should be maintained between 165-170 degrees, so as to ensure that the seams are flat and wrinkle-free. Use a medical iron at 121°C to iron the sutures a second time, holding each position for about 15-20 seconds, then use sterile surgical scissors to trim off the excess fabric, leaving a 2.5-3.0 mm margin.

[0040] Iron the connection again according to the mark, place the first petal frame 130 in the petal frame wrapping cloth, and use back stitch to sew the two ends after folding. Leave a length of 1.5-2.0 mm between the petal frame wrapping cloth and the first petal frame 130 to facilitate the subsequent fixation of the leaflet 140. In one embodiment, the fabric at the connection is folded again according to the previously ironed mark. Place the first petal frame 130 in the petal frame wrapping cloth, and pay attention to maintaining a gap of 1 mm between the first petal frame 130 and the petal frame wrapping cloth. Use 5-0 specification sutures to back stitch and fix the two ends after folding. When suturing, the spacing between each stitch should be maintained between 3.0-3.5 mm, and the suture depth should be controlled within the range of 2.5-3.0 mm. Add reinforcement sutures at key stress positions, and the stitch length of the reinforcement sutures should be maintained at 2.0-2.5 mm. The sewn petal frame 320 is as follows Figure 7 shown.

[0041] A plurality of reserved holes are evenly arranged on the three sides of the leaflet 140 for threading during suturing.

[0042] In step S103, the holes at the midpoints of the three sides of the leaflet 140 are aligned with the lowest point of the sewn second leaflet seat 310, and the three sides are continuously sutured to the top of the second leaflet seat 310 through other holes evenly distributed and preset on each side. After the reserved part 142 of the leaflet is folded in half and sutured, the suture is wrapped around the leaflet seat wrapping cloth 220 and passed out. The steps include: aligning the holes at the midpoints of the three sides of the leaflet 140 with the lowest point of the second leaflet seat 310 respectively; passing sutures through the holes at the midpoints of each side of the leaflet 140 and the corresponding leaflet seat wrapping cloth 220, and using the two ends of the sutures to pass through other holes evenly distributed on the sides of the leaflet 140 to sew the leaflet 140 and the second leaflet seat 310 together until the two ends of each suture pass through the first hole 141 at both ends of each side of the leaflet 140; folding the sutures passing through the first hole 141 in half and passing them through the second hole 143 and the third hole 144 of the leaflet reserved part 142 on the side adjacent to the first hole 141, and knotting the met sutures; wrapping the knotted lines around the corresponding leaflet seat wrapping cloth 220 at the top of the second leaflet 310 from opposite directions, and passing them out from the corresponding vertex hole 145 of the leaflet 140.

[0043] Figure 8 This is a schematic diagram of sewing a valve leaflet and a valve seat disclosed in an embodiment of the present application, referring to Figure 8 , for fixing the leaflets 140 on the sewn second leaflet seat 310, specifically, use the wrapped leaflet seat, align the holes at the midpoints of the three leaflets 140 with the lowest point of the sewn second leaflet seat 310, and use the thread to pass through the fixed position through the punching position, and sew continuously to the top of the sewn second leaflet seat 310 on both sides, and stop at the second hole to reserve the thread for use. In one embodiment, during the fixing process of the leaflets 140, it is first necessary to use the sewn second leaflet seat 310 to align the lowest point of the three leaflets 140 with the lowest point of the sewn leaflet seat 310. The position deviation of each leaflet 140 should not exceed 0.5 mm to ensure the symmetry of the overall structure. Use a special cardiac surgical suture needle to pass a 7-0 specification suture from the preset punching position, which is usually 4.0-4.5 mm above the bottom edge of the leaflet seat. The suture length should be reserved for about 120-150 mm. The suture thread passing through the punching position should be continuously sutured toward the top of both sides of the sewn second petal seat 310, and the tension of the suture thread should be maintained between 0.8-1.2 Newtons. It stops and reserves the suture thread until it reaches the second hole position.

[0044] Sew the part of the outer side of the second petal seat 310 reserved from the leaflet 140 from the outside to the inside, fold the reserved part inward, and pass it to the inside. Similarly, after the inner line passes outward, tie three knots with the two lines. In one embodiment, when processing the sutures on the outside of the second petal seat 310, it is necessary to start from the reserved part of the leaflet 140 and adopt a suturing method from the outside to the inside. The suture depth should be controlled between 2.0-2.5 mm, and the spacing between each stitch should be maintained at 2.5-3.0 mm. Fold the reserved part inward, and the folded width is usually between 4.0-4.5 mm. Process the other two sutures in the same way to ensure that the operating parameters on both sides remain consistent. When the two sutures meet in the middle, it is necessary to use a standard surgical knotting method to tie five knots in a row, and the spacing between each knot is maintained at 2.0 mm, so that sufficient structural strength can be disclosed.

[0045] The knotted thread is then wrapped around the valve seat wrapping cloth in two opposite directions and passed out from the hole punched at the apex. In one embodiment, the knotted suture needs to be fixed around the valve seat wrapping cloth on both sides. The direction of the suture should be parallel to the texture of the valve seat wrapping cloth to avoid local stress concentration. Finally, the suture is passed through the hole punched at the apex, and the angle during the passing should be maintained at 90 degrees, which can reduce the friction between the suture and the cloth. A circular reinforcement area with a diameter of 4.0-4.5 mm is added near the passing point.

[0046] At step S104, the sewn second flap frame 320 is aligned with the sewn second flap seat 310, and the suture is extended through the holes at the midpoints of the three sides of the leaflet 140 to the apex of the second flap seat 310, and the suture is alternately sutured through the flap frame wrapping cloth 210, the reserved holes of the leaflet 140, and the flap seat wrapping cloth 220 in sequence until the apex of the second flap seat 310 is reached and knotted to obtain the valve body. This includes: three equal-length sutures are respectively passed through the holes at the midpoints of the three sides of the leaflet 140; the suture needle passes through the flap frame wrapping cloth 210, the reserved holes of the leaflet 140, and the flap seat wrapping cloth 220 in sequence to complete the first stitch; the second stitch is performed from the second flap seat 310 through the leaflet 140 and the second flap frame 320; the suture steps are repeated until the suture passes through the apex of the second flap seat 310 and is knotted to obtain the valve body.

[0047] Fig. 9 FIG. 1 is a schematic diagram of fixing a petal frame disclosed in an embodiment of the present application. For the fixed sewing of the petal leaf 140, the sewn second petal frame 320, and the sewn second petal seat 310, refer to FIG. Fig. 9, the lines at the three vertices can be passed upward and through the apex of the sewn second petal seat 310, prepare three equal-length lines, find the three lowest points of the sewn second petal seat 310, the leaflet 140, and the sewn second petal frame 320, and after the lines pass through the holes of the leaflet 140, they are respectively passed to both sides according to the holes of the leaflet 140, and the suture needle passes through the leaflet from the petal frame, and the petal seat is wrapped with cloth to complete the first stitch, and then the second petal seat 310 passes through the leaflet 140, and the second petal frame 320 is wrapped and passed out to complete the second stitch, and thus reciprocate until the suture is sutured to the apex of the sewn second petal seat 310 and knotted. Preferably, after the sutures at the three vertices are fixed, these sutures need to be extended upward to the apex of the sewn petal seat 310. Prepare three 6-0 specification sutures with a length between 150-180 mm, and find the lowest points of the leaflet 140, the sewn second petal frame 320, and the sewn second petal seat 310. Starting from the punching point of the leaflet 140, the suture needle needs to pass through the second flap frame 320, the leaflet 140 and the second flap seat 310 in sequence, and the depth of each needle should be maintained between 2.5-3.0 mm. After the first stitch is completed, the second stitch is performed starting from the second flap seat 310, through the leaflet 140 and the first flap frame 130, and this is performed alternately until the apex of the sewn second flap seat 310 is reached, and finally the valve body is obtained. During the suturing process, the tension of the suture should be maintained between 1.0-1.2 Newtons, which can ensure the stability of the structure without affecting the flexibility of the valve. When tying a knot at the apex, the diameter of the node is controlled between 2.5-3.0 mm.

[0048] At step S105, the valve ring 110 is sutured and fixed below the second valve seat 310 in the valve body to obtain a polymer valve. This includes: aligning the short ends of the valve ring wrapping cloth 150, suturing continuously into a ring shape, placing the valve ring 110 in the middle of the valve ring wrapping cloth 150, suturing the valve ring 110 in the valve ring wrapping cloth 150 by hiding the needle method, tightening the suture to form a wrapped felt valve ring; then, aligning the wrapped felt valve ring with the bottom of the second valve seat 310; suturing and fixing the suture through the reserved holes of the felt valve ring and the second valve seat 310 by continuous suturing; adding reinforcement sutures in high stress areas to obtain a polymer valve. Fig.10 The present invention discloses a process of wrapping a valve ring and sewing the wrapped valve ring to the valve body to obtain a polymer valve. In one implementation scenario, the valve ring 110 can be fixed by directly sewing the cut valve ring 110 to the bottom of the second valve seat 310 of the valve body according to the holes punched in the second valve seat 310, and the valve ring 110 is fixed by back-stitching. Preferably, the pre-prepared valve ring 110 cut from medical-grade felt is positioned according to the punching position of the second valve seat 310, wherein the thickness of the valve ring 110 is between 2.5-3.0 mm. Fig.10As shown, the short ends of the valve ring wrapping cloth 150 are aligned and sutured continuously into a ring shape, the valve ring 110 is placed in the middle of the valve ring wrapping cloth 150, the valve ring 110 is sutured into the valve ring wrapping cloth 150 by the needle hiding method, the suture is tightened to form a wrapped felt valve ring, and the wrapped valve ring 110 or the felt valve ring is fixed under the second valve seat 310 by back stitching with 5-0 specification sutures. The needle distance during suturing is controlled between 2.5-3.0 mm, and the depth is maintained at 2.0-2.5 mm. During the suturing process, attention should be paid to maintaining uniform tension, usually between 0.8-1.0 Newtons, so as to avoid local deformation. Reinforcement sutures are added in high stress areas, and the needle distance of the reinforcement sutures should be maintained at 2.0-2.5 mm. After the fixation is completed, the entire valve ring 110 needs to be fully inspected in accordance with the ISO 5840 standard.

[0049] It should be understood that the structures shown in the drawings of the embodiments of the present application are exemplary and non-restrictive. This means that the structures involved are not limited to a specific form or design, but are presented as examples. In other words, the structures shown in the drawings can be regarded as a way of expression to clearly describe related concepts and relationships, and do not exclude other forms of structures. Therefore, when interpreting the structures in the pictures, it should be understood that the purpose is to disclose an exemplary description rather than a restrictive provision on a specific form.

[0050] The embodiment of the present application discloses a polymer valve using the suture preparation method described in any of the above embodiments, comprising: a valve ring 110, a first valve seat 120, a first valve frame 130, a valve leaflet 140, and a valve frame wrapping cloth and a valve seat wrapping cloth; the valve ring 110 is arranged at the bottom of the valve, adopts an annular structure, and its upper surface is connected to the valve seat 120; the valve seat 120 is an annular step-shaped structure, and its inner side wall is provided with a groove for installing the valve leaflet 140, and the outer peripheral wall is matched with the valve ring 110; the upper surface of the valve seat 120 is provided with a positioning structure that cooperates with the valve frame 130, and the positioning structure includes a plurality of bosses uniformly distributed along the circumference of the valve seat 120. The valve frame 130 is composed of three pillars, the lower ends of the pillars are fixedly connected to the positioning structure on the valve seat 120, and the upper ends are connected to each other to form a supporting structure; the valve leaflet 140 is made of polymer material, in the form of a thin sheet, and its edge is fixedly connected to the valve seat 120 and the valve frame 130 through sutures. The valve frame wrapping cloth 210 covers the surface of the valve frame 130 and is fixed by back-stitching; the valve seat wrapping cloth 220 covers the outer surface of the valve seat 120 and is fixed by back-stitching.

[0051] In one specific embodiment, the production process of the petal seat wrapping cloth adopts a special sewing process: first, the cut petal seat wrapping cloth is folded in half so that the inner edge is slightly longer than the outer edge by about 2 mm, and then the left and right ends are aligned and ironed to form a crease. After the petal seat wrapping cloth is unfolded, the left and right ends are sewed by cross stitching to form a barrel-shaped structure. After the petal seat 120 is placed in the petal seat wrapping cloth, the petal seat 120 is fixed inside the petal seat wrapping cloth by a back stitching process, and the stitch length of the suture line is maintained between 1.5 and 2.5 mm. After the excess petal seat wrapping cloth is rolled and folded, it is fixed to the surface of the original petal seat wrapping cloth by continuous stitching. The installation of the petal frame wrapping cloth needs to consider the seam processing: the oblique line connection back stitching method is used at the joint. After the stitching is completed, the two triangular fabrics are unfolded and ironed to ensure that the seam is flat. When the petal frame 130 is placed in the petal frame wrapping cloth, a gap of about 1 mm is maintained between it and the petal seat wrapping cloth. This design facilitates the subsequent fixation of the leaflet 140.

[0052] During the installation of the leaflets 140, a positioning suture technique is used: first, align the lowest point of the three leaflets 140 with the lowest point of the valve seat 120, and pass the suture through the special positioning hole and temporarily fix it. Subsequently, continuous sutures are performed along the top of both sides of the valve seat 120, and the sutures are paused at the second positioning hole and reserved. The sutures on the left side of the valve seat 120 need to be sutured from left to right from the reserved part of the leaflet 140, and the reserved part is folded inward and passed to the right side; the sutures on the right side need to be passed to the left, and the two sutures are finally knotted and fixed. After the fixation is completed, the sutures are then wrapped around the valve seat wrapping cloth from the left and right sides, and finally passed through the positioning hole at the apex. In the triple fixation process of the leaflets 140, the valve frame 130 and the valve seat 120, first prepare three sutures of equal length, find the lowest point of the three components, and pass the sutures through the positioning holes of the leaflets 140. The suture needle needs to pass through the valve frame 130, the valve leaflets 140 and the valve seat wrapping cloth in a specific path to form the first suture; then pass through the valve leaflets 140 and the valve frame 130 from the valve seat 120, and pass out in a winding manner to complete the second suture, and repeat this process until the suture is made to the top of the valve frame 130 and tied and fixed. Finally, the pre-cut valve ring 110 is fixed under the valve seat 120 through the positioning hole on the valve seat 120 by back stitching, completing the assembly of the entire valve.

[0053] Furthermore, an embodiment of the present application also discloses a three-dimensional modeling device for a valve frame, comprising: a processor, a memory, and a system bus; the processor and the memory are connected via the system bus; the memory is used to store one or more programs, and the one or more programs include instructions, which, when executed by the processor, enable the processor to execute any of the above methods.

[0054] Furthermore, an embodiment of the present application also discloses a computer program product, which, when executed on a terminal device, enables the terminal device to execute any of the above methods.

[0055] It can be known from the description of the above implementation mode that those skilled in the art can clearly understand that all or part of the steps in the above-mentioned embodiment method can be implemented by means of software plus a necessary general hardware platform. Based on such an understanding, the technical solution of the present application can be essentially or partly embodied in the form of a software product that contributes to the prior art. The computer software product can be stored in a storage medium such as ROM / RAM, a disk, an optical disk, etc., including several instructions for enabling a computer device (which can be a personal computer, a server, or a network communication device such as a media gateway, etc.) to execute the methods described in the various embodiments of the present application or certain parts of the embodiments.

[0056] It should be noted that the various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments, and the same or similar parts between the various embodiments can be referred 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 parts can be referred to the method part description.

[0057] It should also be noted that, in the embodiments of the present application, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply that there is any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that the process, method, article or equipment including a series of elements includes not only those elements, but also includes other elements that are not clearly listed, or also includes elements inherent to such process, method, article or equipment. In the absence of more restrictions, the elements limited by the statement "comprise one..." do not exclude the presence of other identical elements in the process, method, article or equipment including the elements.

[0058] The above description of the disclosed embodiments enables professionals and technicians in the field to implement or use the present application. Various modifications to these embodiments will be apparent to professionals and technicians in the field, and the general principles defined in the embodiments of the present application can be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application will not be limited to these embodiments shown in the embodiments of the present application, but will conform to the widest range consistent with the principles and novel features disclosed in the embodiments of the present application.

Claims

1. A method for suturing and preparing a polymer valve, characterized in that: include: The petal seat wrapping cloth (220) is cut, folded in half, ironed and shaped, and cross-stitched to form a tube; the first petal seat (120) is placed in the sewn tube and fixed by back stitching; the excess part is rolled up and fixed by continuous stitching to obtain a sewn second petal seat (310); According to the unfolded view of the three-dimensional model of the first petal frame (130), a petal frame wrapping cloth (210) is produced, the connection is sewn with back stitches using oblique lines and ironed, the first petal frame (130) is placed therein and fixed with back stitches to obtain a sewn second petal frame (320); Align the holes at the midpoints of the three sides of the leaflet (140) with the lowest point of the sewn second leaflet seat (310), and sew continuously from the midpoints of the three sides through other holes uniformly preset on each side to the top of the second leaflet seat (310), and after folding and sew- ing the reserved part (142) of the leaflet, wrap the suture around the leaflet seat wrapping cloth (220) and pass it out; Aligning the sewn second flap frame (320) with the sewn second flap seat (310), extending the suture through the holes at the midpoints of the three sides of the flap (140) toward the apex of the second flap seat (310), and alternately sew through the flap frame wrapping cloth (210), the reserved holes of the flap (140), and the flap seat wrapping cloth (220) in sequence until the apex of the second flap seat (310) is reached and knotted to secure, thereby obtaining a valve body; The valve ring (110) is sutured and fixed below the second valve seat (310) in the valve body to obtain a polymer valve.

2. The suture preparation method according to claim 1, characterized in that: in, The petal seat wrapping cloth (220) is cut and folded in half and ironed to shape, and then cross-stitched to form a tube shape, the first petal seat (120) is placed in the sewn tube shape and fixed by back stitching, and the excess part is rolled and fixed by continuous stitching to obtain the sewn second petal seat (310), including: Cutting the petal seat wrapping cloth (220) according to the three-dimensional shape characteristics of the first petal seat (120) so that one side edge thereof is longer than the other side edge; After the petal seat wrapping cloth (220) is folded in half, the fold is ironed using an ironing device; Opening the petal seat wrapping cloth (220), and sewing the left and right ends of the petal seat wrapping cloth (220) into a tubular structure by cross-stitching; The first petal seat (120) is placed in a cylindrical petal seat wrapping cloth (220) and fixed by back stitching; The excess petal seat wrapping cloth (220) is rolled up and fixed to the petal seat wrapping cloth (220) by continuous sewing, so as to obtain a sewn second petal seat (310).

3. The suture preparation method according to claim 1, characterized in that: in, According to the unfolded view of the three-dimensional model of the first petal frame (130), a petal frame wrapping cloth (210) is produced, the connection is sewn with back stitches using oblique lines and ironed, the first petal frame (130) is placed therein and fixed with back stitches to obtain a sewn second petal frame (320), comprising: Establishing a three-dimensional curved surface model according to the width and perimeter of the first petal frame (130) and unfolding it into a plane diagram to produce a petal frame wrapping cloth (210); Fold the petal frame wrapping cloth (210) in half according to the number of wrapped layers and iron it to create a mark; The joint of the flap frame wrapping cloth (210) is connected by an oblique line and sutured with a back stitch; Unfold the triangular cloth formed at the joint, iron it flat, and then cut off the excess part; Iron the connection again according to the mark, and place the first petal frame (130) into the petal frame wrapping cloth (210); The two ends of the folded flap are fixed by back stitching, so that a gap is left between the flap frame wrapping cloth (210) and the first flap frame (130), thereby obtaining a sewn second flap frame (320).

4. The suture preparation method according to claim 1, characterized in that: in, The holes at the midpoints of the three sides of the leaflet (140) are aligned with the lowest point of the sewn second leaflet seat (310), and the three sides are continuously sutured to the top of the second leaflet seat (310) through other holes uniformly distributed and preset on each side, and the suture is wrapped around the leaflet seat wrapping cloth (220) and passed out after the reserved part (142) of the leaflet is folded in half and sutured, including: Align the holes at the midpoints of the three sides of the leaflet (140) with the lowest point of the second leaflet seat (310) respectively; Passing sutures through the holes at the midpoint of each side of the leaflet (140) and the corresponding leaflet seat wrapping cloth (220), and using the two ends of the sutures to pass through other holes uniformly preset on each side of the leaflet (140), the leaflet (140) and the second leaflet seat (310) are sutured together until the two ends of each suture pass through the first holes (141) at both ends of each side of the leaflet (140); The suture thread passing through the first hole position (141) is folded in half and passed through the second hole position (143) and the third hole position (144) of the leaflet reserved portion (142) adjacent to the first hole position (141), and the suture threads that meet are knotted; The knotted threads are respectively wound around the corresponding second petal seat wrapping cloth (220) at the top end of the second petal seat (310) from opposite directions, and passed through the corresponding vertex hole (145) of the leaflet (140).

5. The suture preparation method according to claim 1, characterized in that: in, The sewn second petal frame (320) is aligned with the sewn second petal seat (310), and the suture is extended through the holes at the midpoints of the three sides of the petal leaf (140) toward the apex of the second petal seat (310), and the suture is alternately sutured through the petal frame wrapping cloth (210), the reserved holes of the petal leaf (140), and the petal seat wrapping cloth (220) in sequence until the apex of the second petal seat (310) is reached and knotted and fixed, including: Pass three sutures of equal length through the holes at the midpoints of the three sides of the leaflet (140); The suture needle sequentially passes through the valve frame wrapping cloth (210), the reserved hole of the valve leaflet (140), and the valve seat wrapping cloth (220) to complete the first stitch; Perform a second stitch from the second petal seat (310) through the petal leaflet (140) and the second petal frame (320); The suturing step is repeated until the suture passes through the apex of the second petal seat (310) and is tied and fixed.

6. The suture preparation method according to claim 1, characterized in that: in, The valve ring (110) is sutured and fixed below the second valve seat (310) in the valve body to obtain a polymer valve, including: aligning the short ends of the valve ring wrapping cloth (150), continuously suturing them into a ring shape, placing the valve ring (110) in the middle of the valve ring wrapping cloth (150), suturing the valve ring (110) into the valve ring wrapping cloth (150) by using a needle hiding method, and tightening the suture to form a wrapped felt valve ring; The wrapped felt valve ring is aligned with the bottom of the second valve seat (310); and a continuous suturing method is used to continuously pass sutures through the reserved holes of the felt valve ring and the second valve seat (310) to sew and fix them.

7. The suture preparation method according to claim 3, characterized in that: in, A three-dimensional surface model is established according to the width and perimeter of the first petal frame and unfolded into a plane view to produce a petal frame wrapping cloth, including: The three-dimensional geometry of the valve frame is established by using the control point coordinates and Bernstein basis functions, and is converted into a quadrilateral mesh model; Establish a Riemann metric tensor component calculation model and combine the cutting path to unfold the three-dimensional surface into a two-dimensional plane graph; Calculate the actual circumference of the flap frame and determine the cutting size and allowance of the fabric according to the number of wrapped layers.

8. The suture preparation method according to claim 7, characterized in that: in, The three-dimensional geometry of the valve frame is established through the control point coordinates and Bernstein basis functions, and converted into a quadrilateral mesh model, including: The Bezier surface equation is used to construct the continuous and differentiable three-dimensional geometry of the valve frame; Calculate the position vector of any point through the control point coordinates and Bernstein basis function; Convert continuous surfaces into quadrilateral mesh models; The local features of the valve frame surface are locally encrypted.

9. The suture preparation method according to claim 7, characterized in that: in, Establish a Riemann metric tensor component calculation model, and combine the cutting path to unfold the three-dimensional surface into a two-dimensional plane graph, including: Determine the minimum strain energy cutting path on the valve frame surface; Establish a Riemannian metric tensor component calculation model; Unfold the three-dimensional surface along the determined cutting path; The two-dimensional coordinates of the mesh nodes are calculated using the unfolding reference point as the starting point.

10. A polymer valve using the suture preparation method according to any one of claims 1 to 9, characterized in that: include: A valve ring (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); the valve ring (110) is arranged at the bottom of the valve and adopts an annular structure, and its upper surface is connected to the first valve seat (120); the first valve seat (120) is an annular step-shaped structure, and the bottom peripheral wall is matched with the valve ring (110); the upper surface of the first valve seat (120) is provided with a positioning structure that cooperates with the first valve frame (130), and the first valve frame (130) consists of three The first petal seat (120) and the first petal frame (130) are composed of a plurality of pillars, the lower ends of the pillars are fixedly connected to the positioning structure on the first petal seat (120), and the upper ends are connected to each other to form a supporting structure; the leaflets (140) are made of polymer material and are in the form of thin sheets, and a plurality of holes are reserved at the edges thereof, and are fixedly connected to the first petal seat (120) and the first petal frame (130) by sutures; the petal frame wrapping cloth (210) covers the surface of the first petal frame (130) and is fixed by back stitching; the petal seat wrapping cloth (220) covers the outer surface of the first petal seat (120) and is fixed by back stitching.

Images