WO2019154124A1

WO2019154124A1 - Prosthetic valve and prosthetic valve device

Info

Publication number: WO2019154124A1
Application number: PCT/CN2019/073156
Authority: WO
Inventors: 史欢欢; 周庆亮; 可大年; 孟坚
Original assignee: 北京迈迪顶峰医疗科技有限公司
Priority date: 2018-02-06
Filing date: 2019-01-25
Publication date: 2019-08-15
Also published as: CN108125732A

Abstract

A prosthetic valve (300) and a prosthetic valve device (400). The prosthetic valve (300) comprises a sealing membrane (110) and a valve leaflet (210). The sealing membrane (110) has a cylindrical shape, and both ends thereof are respectively provided with an outward expansion port. The ends of the outward expansion ports have tooth-shaped structures. A middle part of the sealing membrane (110) is a straight cylinder. The inner diameter of the outward expansion ports is greater than the inner diameter of the middle part of the sealing membrane (110). The sealing membrane (110) is formed by suturing at least three sealing membrane units (100). The valve leaflet (210) is a circular structure formed by suturing and connecting at least three valve leaflet units (200). The valve leaflet (210) is provided at the middle part of the sealing membrane (110). The prosthetic valve device (400) comprises the prosthetic valve (300) and a valve support (500). The aim of the present invention is to provide a prosthetic valve (300) and a prosthetic valve device (400) for improving pulmonary regurgitation, and to improve safety and efficacy of use.

Description

Artificial valve and prosthetic valve device

The present invention claims priority from the applicant's application, which is filed on February 6, 2018, with the application number of CN201810116225.1, entitled "Prosthetic Valve and Prosthetic Valve Device". The entire contents of the above application are hereby incorporated by reference in its entirety.

Technical field

The invention relates to a heart valve technology in the field of medical instruments, and belongs to the field of interventional treatment instruments, in particular to a prosthetic valve and a prosthetic valve device.

Background of the invention

Congenital heart disease is a congenital cardiovascular system malformation caused by abnormal heart and blood vessels during fetal period. It is the most common heart disease in childhood. According to statistics, 6 to 7 out of every 1,000 newborns have congenital heart malformations. According to demographers, there are about 10 million people suffering from congenital heart disease in China, and about 200,000 children with congenital heart disease are added each year, of which complex congenital heart disease accounts for about 20%. Many complex congenital heart disease lesions can seriously affect the right ventricular outflow tract and require surgical reconstruction. Pulmonary valve regurgitation or restenosis often occurs after surgery, so the right ventricular outflow tract needs to be reconstructed again by surgery.

Transcatheter pulmonary valve replacement can not only correct stenosis, but also treat valvular regurgitation. This technique is used to place the artificial valve stent through the catheter into the autologous pulmonary valve through the peripheral venous approach, replacing the lost pulmonary valve to achieve treatment. purpose.

The causes of pulmonary regurgitation are as follows: 1 complete congenital pulmonary valve malformation: can be completely missing, single-leaf pulmonary valve and other malformations, common in patients with tetralogy of Fallot. 2 Ma Fang Syndrome: The lesion mainly involves the aortic valve and the mitral valve, but it has been reported that about 26.9% of the patients have pulmonary valve involvement and pulmonary regurgitation. 3 cardiac tumors: papillary fibroelastoma is closely related to pulmonary valve disease, showing that the tumor has multiple lobes and is attached to the endocardium through the pedicle. Common in the aortic valve or pulmonary valve ventricle. Increased adherent tumor volume may result in moderate to severe pulmonary regurgitation, with or without pulmonary stenosis. 4 pulmonary valve annulus dilatation: such as long-term pulmonary hypertension can lead to pulmonary artery and annulus dilatation, leading to pulmonary regurgitation. In patients with stenosis of the right ventricular outflow tract (RVOT) and obstruction, the stenosis may expand and expand the annulus, causing pulmonary regurgitation. 5 iatrogenic: It is the most clinically significant and most common factor in the clinic, and it is also the most suitable group for percutaneous pulmonary valve implantation (PPVI). In China, patients with pulmonary stenosis such as tetralogy of Fallot have undergone RVOT transvalvular surgery (RVOT, longitudinal incision of the pulmonary artery and then patch to enlarge the diameter of the lumen) to relieve pulmonary stenosis. However, it will enlarge the pulmonary valve annulus, and the valve leaflets will be poorly combined, resulting in obvious pulmonary shunt. Many foreign heart centers will place valved artificial blood vessels in the ROVT, although there will be no pulmonary regurgitation in the short term, but long-term After application, the artificial blood vessels will be calcified and cause outflow obstruction, and the biological valve will be degraded and cause valve insufficiency or stenosis. This type of population is currently the main application group of PPVI.

In October 2000, Bonhoeffer's team reported the first clinical use of PPVI, which successfully performed a PPVI procedure in a 12-year-old patient with pulmonary stenosis and reflux after Fello-Fed disease repair. This technique was then used for more patients. In 2005, Bonhoeffer reported on PPTV in 100 patients with congenital diseases such as pulmonary regurgitation or RVOT obstruction aged 16-35 years during the TCT meeting. There was no death after 0.5-5 years of follow-up, and the right ventricular pressure decreased significantly after surgery. The exercise tolerance is significantly improved.

The advantages of percutaneous pulmonary valve replacement compared with surgical thoracotomy are: (1) no long-term anticoagulation is required; (2) near normal hemodynamics after replacement; (3) maintenance of long-term histological and functional integrity Sex; (4) small trauma and light injury.

There are two types of prosthetic heart valves commonly used in percutaneous heart valve replacement: one is Medtronic's Melody balloon dilatation interventional valve. The Melody device is a three-lobed bovine jugular vein valve sewed on a platinum-rhodium balloon-expandable alloy stent. The inner diameter of the implanted valve during expansion is varied from 10 to 22 mm, which is attributed to the good elasticity of the leaflets made by the venous valve and the larger leaflet interface. The conventional size is 18 to 22 mm. The other is Edwards' SAPIEN balloon dilatation interventional valve. The stent of the SAPIEN valve is made of stainless steel and uses a durable bovine pericardium as the leaflet material, while the seal cuff is also made higher to reduce the occurrence of paravalvular leakage. The valve is currently available in 23mm, 26mm and other models. Their structures are straight and the pulmonary annulus is 16 to 22 mm in diameter, which is not suitable for patients with pulmonary valve annulus and major pulmonary malformations.

Summary of the invention

The technical problem to be solved by the present invention is to provide a prosthetic valve and a prosthetic valve device for improving pulmonary regurgitation, and to improve the safety and effectiveness of transcatheter reconstruction of a pulmonary valve.

The prosthetic valve of the present invention comprises a sealing membrane and a leaflet, the sealing membrane is in the shape of a cylinder, and an outer flare is provided at each end of the sealing membrane, and the port of the outer flare is a toothed structure. The middle portion of the sealing film has a straight cylindrical shape, the inner diameter of the outer flare is larger than the inner diameter of the middle portion of the sealing film, and the sealing film is stitched by at least three sealing film units, and the leaflets are at least three petals The leaf unit is sutured to form an annular structure, the leaflets being disposed in the middle of the sealing film.

In the artificial valve of the present invention, the upper and lower ends of the sealing film unit are respectively inclined outwardly, and the upper and lower ends of the sealing film unit are respectively provided with reinforcing ears, and the reinforcing ears constitute the outer flare port The toothed structure has a rectangular shape in a middle portion of the sealing film unit, and both sides of the sealing film unit are stitched edges.

The prosthetic valve of the present invention, wherein the sewn edge penetrates from the upper end of the sealing film unit to the lower end of the sealing film unit.

The prosthetic valve of the present invention, wherein the sewn side is a groove-like side having a width of 0.5 to 3 mm.

The prosthetic valve of the present invention, wherein the leaflet unit comprises an upper rectangular shape and a lower rectangular shape, wherein the upper rectangular shape and the lower rectangular shape are connected by respective long sides, and the long side length of the upper rectangular shape is larger than The length of the long side of the rectangle is described, and the two corners of the lower side of the lower rectangle are removed and rounded, the two short sides of the upper rectangle are the stitching ears, and the edges of the lower rectangle are fixed edges.

In the artificial valve of the present invention, the width of the fixed side is 0.5 to 3 mm.

The prosthetic valve of the present invention, wherein the leaflet unit of the leaflet is evenly arranged in the circumferential direction of the middle portion of the sealing film.

In the artificial valve of the present invention, the sealing film is sutured by three sealing film units, and the leaflets are formed by suturing and connecting three leaflet units.

In the artificial valve of the present invention, the suturing manner of the suture edges of two adjacent sealing film units is a spiral stitching method or a rack stitching method in which two sides are alternately passed or a matrix stitching method or a cross stitching method.

In the artificial valve of the present invention, in the suturing manner of the suture edges of two adjacent sealing film units, the distance between the adjacent two needle insertion points along the sewn side is 1 to 4 mm.

In the artificial valve of the present invention, the suturing manner of the suture edges of two adjacent sealing film units is a manner in which the ferrule is knotted, and the distance between adjacent two knotting nodes is 1 to 4 mm.

In the artificial valve of the present invention, the suture method of the leaflet on the sealing film is a rack stitching method or a spiral stitching method or a matrix stitching method in which the fixed edge of the leaflet unit alternates between the sealing film and the leaflet. Or zigzag stitching.

In the artificial valve of the present invention, in the suturing manner of the leaflets on the sealing film, the distance between the adjacent two needle insertion points along the fixed side is 1 to 4 mm.

In the artificial valve of the present invention, the suture of the leaflet on the sealing film is alternately passed between the sealing film and the leaflet along the fixed edge of the leaflet so that each node is T-shaped, and two adjacent nodes are The distance between them is 1 to 4 mm.

The prosthetic valve device of the present invention comprises a prosthetic valve and a valve frame, wherein the valve frame has a lattice structure in which both ends are in a lotus shape and a straight tube in the middle, and the leaf frame is upper, middle and lower in order from top to bottom. The upper part and the lower part are in the shape of a lotus flower, and the middle part is in the shape of the straight tube, each part is formed by a plurality of rhomboids connected to each other, the artificial valve is the artificial valve described above, and the sealing film is two The outer flares of the ends are respectively matched with the lotus-like ends of the valve holder, the middle portion of the sealing film is matched with the middle portion of the valve holder, and the sealing film is sewn to the inner wall of the valve holder.

The prosthetic valve device of the present invention, wherein the upper and middle portions of the valve holder and between the middle portion and the lower portion are connected by a rigid vertical rod.

In the artificial valve device of the present invention, the rigid vertical rod connecting the upper portion and the middle portion is evenly arranged along the circumferential direction of the valve holder, and the rigid vertical rod connecting the middle portion and the lower portion is arranged in a one-to-one correspondence between the rhomboid shape in the middle portion and the rhomboid portion in the lower portion. between.

In the artificial valve device of the present invention, both ends of the sealing film are respectively sutured at one end of the valve frame in a one-to-one manner in a wrapped manner.

In the artificial valve device of the present invention, the suture manner of the artificial valve on the valve frame is a manner in which the upper and lower ends are knotted by the ferrule, and the remaining positions are the steps of the rhomboid rod along the valve frame. The semi-annular way is stitched around the rod.

In the prosthetic valve device of the present invention, the suture is wound around the rod in a stepped semi-annular manner, and the distance between adjacent two half rings is 1 to 5 mm.

The prosthetic valve of the present invention is different from the prior art in that the prosthetic valve sutures the leaflet in the interior of the sealing film having a bowl-shaped end, and the highest point of the leaflet is lower than the upper edge of the sealing film. The leaflets are completely wrapped in the sealing membrane. When the leaflets are closed, the blood returning from the upper end of the prosthetic valve is completely confined in the space formed by the sealing membrane and the closed leaflets, improving the pulmonary valve regurgitation. The flow, the outward lotus-like structure at both ends (ie, the external flare of the toothed structure) can be applied to lesions of pulmonary enlargement or deformity. The leaflet structure of the prosthetic valve conforms to the fluid dynamic structure, and the suture of the prosthetic valve is firm and reliable, improving the safety and effectiveness of use.

In order to improve the deficiencies of the prior art, the present invention also provides a prosthetic valve device which is simple in structure, has a fixed artificial valve suture, and can reduce blood reflux.

The invention will now be further described with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a schematic view showing the structure of a sealing film unit in the present invention;

2 is a schematic structural view of a sealing film in the present invention;

3 is a schematic structural view of a leaflet unit in the present invention;

Figure 4 is a schematic view showing the structure of the leaflets in the present invention;

Figure 5 is a schematic view showing the structure of a prosthetic valve in the present invention;

Figure 6 is a schematic structural view of a prosthetic valve device in the present invention;

Figure 7 is a schematic view showing the manner in which the ferrule is knotted and stitched in the present invention;

Figure 8 is a schematic view of a spiral stitching method in the present invention;

Figure 9 is a schematic view showing a rack-shaped suturing method in the present invention;

Figure 10 is a schematic view of a matrix stitching method in the present invention;

Figure 11 is a schematic view of a cross stitching method in the present invention;

Figure 12 is a schematic view showing a zigzag stitching manner in the present invention;

Figure 13 is a schematic view of a T-shaped suture method in the present invention;

Figure 14 is a schematic view of a stepped semi-annular suture in the present invention.

Among them, the various reference numerals in the figure:

100-sealing membrane unit, 101-sealing edge of sealing film unit, 102-reinforcing ear of sealing film unit, 103-matching edge with bracket, 110-seal film, 111-seal upper edge, 112-seal lower edge , 113-sealing film splicing line, 114- sealing film at the middle and the end of the boundary line, 200-valve unit, 201-sewed ear, 202-valve unit fixed side, 203-valve unit free side, 210-valve , 211-stitched ear splicing section, 212-valve fixed edge, 300-prosthetic valve, suture path of 301-valve leaf in sealing membrane, 400-prosthetic valve device, 500-valve.

Mode for carrying out the invention

As shown in FIG. 5, and in conjunction with FIG. 1-4, the prosthetic valve of the present invention includes a sealing film 110 and a leaflet 210. The sealing film 110 has a cylindrical shape, and each end of the sealing film 110 has an external expansion. The port of the outer flared port has a tooth-shaped structure. Thus, both ends of the sealing film 110 are in the shape of a lotus flower, and the middle portion of the sealing film 110 has a straight cylindrical shape, and the inner diameter of the outer flared opening is larger than the inner diameter of the middle portion of the sealing film 110. The sealing film 110 is sewn by at least three sealing film units 100. The leaflets 210 are an annular structure in which at least three leaflet units 200 are stitched and connected, and the leaflets 210 are disposed in the middle of the sealing film 110.

As shown in FIG. 2, in the prosthetic valve of the present invention, the upper and lower ends of the sealing membrane unit 100 are respectively inclined outwardly, and the upper and lower ends of the sealing membrane unit 100 are respectively provided with reinforcing ears 102, and the reinforcing ears 102 constitute an external flare. The tooth-shaped structure at the port can be seen that the sealing film unit 100 has a crown shape with both ends outward, the middle portion of the sealing film unit 100 is rectangular, the two sides of the sealing film unit 100 are the stitching edges 101, and the stitching edges 101 are wide. Groove-like sides of 0.5 to 3 mm.

As shown in FIG. 3, the prosthetic valve of the present invention, wherein the leaflet unit 200 comprises an upper rectangle and a lower rectangle integrally formed, the upper rectangle and the lower rectangle are connected by respective long sides, and the long side length of the upper rectangle is larger than the lower rectangle. The length of the long side, the two corners of the lower side of the lower rectangle are removed and rounded, the two short sides of the upper rectangle are the stitching ears 201, the edges of the lower rectangle are the fixed sides 202, and the width of the fixed side 202 is 0.5~ 3mm.

The prosthetic valve in the present invention, in which the leaflet unit 200 of the leaflet 210 is evenly arranged in the circumferential direction of the central portion of the sealing film 110.

As shown in FIG. 8-11, in the artificial valve of the present invention, the suturing manner of the suture edge 101 of two adjacent sealing film units is a spiral stitching method or a rack stitching method or a matrix stitching method or a cross which alternately passes through two sides. Stitching method.

As shown in FIG. 7 , in the prosthetic valve of the present invention, the suturing manner of the suture edge 101 of two adjacent sealing membrane units is a manner in which the ferrule is knotted, and the distance between two adjacent knotting nodes is 1 to 4 mm. .

8, 9, 10, 12, the prosthetic valve of the present invention, wherein the suture of the leaflet 210 on the sealing membrane 110 is alternated between the sealing membrane 110 and the leaflet 210 along the fixed edge 202 of the leaflet unit Through the rack stitching or spiral stitching or matrix stitching or zigzag stitching.

In the stitching manner of the leaflets 210 on the sealing film 110, the distance between the adjacent two needle insertion points along the fixed side 202 is 1 to 4 mm.

As shown in FIG. 13, the prosthetic valve of the present invention, wherein the leaflet 210 is sutured on the sealing film 110, alternately passes between the sealing film 110 and the leaflet 210 along the leaflet fixed edge 202 so that each node is T-shaped, the distance between two adjacent nodes is 1 to 4 mm, and the above-mentioned suture method is a T-shaped suture method.

As shown in FIG. 6, the prosthetic valve device 400 of the present invention includes a prosthetic valve 300 and a valve holder 500. The valve holder 500 has a lattice structure in which both ends are lotus-shaped and have a straight cylindrical shape in the middle, and the valve holder 500 is from top to bottom. The upper part, the middle part and the lower part are in the shape of a lotus flower, and the upper part and the lower part are in a lotus shape, and the middle part is a straight tube shape, and each part is formed by a plurality of rhomboids connected to each other. The artificial valve 300 is the above-mentioned artificial valve, and the outer ends of the sealing film 110 are expanded. The mouths are respectively matched with the lotus-like ends of the valve holder 500, the middle portion of the sealing film 110 is matched with the middle portion of the valve holder 500, and the sealing film 110 is sewn to the inner wall of the valve holder 500.

The prosthetic valve device 400 of the present invention, wherein the upper and middle portions of the valve holder 500 and between the middle portion and the lower portion are connected by a rigid vertical rod, and the rigid vertical rods connecting the upper portion and the middle portion are evenly arranged along the circumferential direction of the valve holder 500. The connecting central portion and the lower rigid vertical rod are arranged in one-to-one correspondence between the rhomboid shape in the middle portion and the rhomboid shape in the lower portion, as shown in FIG. 6, that is, the rhomboids corresponding to the middle portion and the lower portion pass through a rigidity. The vertical rods are connected, and the two ends of the sealing film 110 are respectively sutured in a one-to-one manner on the two ends of the valve holder 500. The suture manner of the artificial valve 300 on the valve holder 500 is a manner in which the upper and lower ends are knotted by the ferrule. (As shown in Fig. 7), the remaining positions are the rhomboid-shaped rods along the valve holder 500, which are stitched around the rod in a stepped semi-annular manner (as shown in Fig. 14), and the distance between adjacent two half rings is 1~. 5mm.

The prosthetic valve 300 of the present invention sutures the leaflets 210 inside the sealing film 110 having a bowl-shaped end, and the highest point of the leaflets 210 is lower than the upper end edge of the sealing film 110, so that the leaflets 210 are completely wrapped Among the sealing films 110, when the leaflets 210 are closed, the blood returning from the upper end of the prosthetic valve 300 is completely confined in the space formed by the sealing membrane 110 and the closed leaflets 210, improving pulmonary regurgitation, The outward lotus-like structure at both ends (ie, the flared outer shape of the toothed structure) can be applied to lesions of pulmonary artery enlargement or deformity. The leaflet structure of the prosthetic valve conforms to the fluid dynamic structure, and the suture of the prosthetic valve is firm and reliable, improving the safety and effectiveness of use.

As shown in Fig. 6, in order to improve the deficiencies of the prior art, the present invention also provides a prosthetic valve device 400 which is simple in structure, has a fixed artificial valve suture, and can reduce blood reflux.

The sealing film 110 in this embodiment is formed by stitching the stitching edges 101 on the three sealing film units two by two, and the leaflets 210 are stitched and connected by three leaflet units 200, and the stitching edge 101 of the sealing film unit is The upper end of the sealing film unit 100 is penetrated to the lower end of the sealing film unit 100. The central portion of the sealing film 110 is provided with a leaflet 210 in a straight cylindrical shape. The leaflet 210 is an annular structure formed by stitching the stitching ears 201 on the leaflet unit 200. The suture path of the leaflet 210 on the sealing film 110 is the fixed side 202 of the leaflet unit, and the suture ears 201 after the leaflet unit 200 are connected are evenly distributed in the circumferential direction of the middle of the sealing film 110. The sealing membrane 110 and the suture ears 201 of the leaflets 210 are both fixed on the valve holder 500 which is straight in the shape of a lotus flower at both ends, and the valve holder 500 has a mesh structure; the valve holder 500 is composed of three parts from top to bottom. Each part is made up of several rhomboids connected to each other. The prosthetic valve 300 is sutured to a matching valve holder 500 to form a prosthetic valve device 400.

A plurality of reinforcing portions (i.e., the reinforcing ears 102 described above) are distributed at both ends of the sealing film unit 100, and the reinforcing portions are sewn to the opposite ends of the corresponding valve holder 500.

The leaflet unit 200 is in the shape of a flower pot. The fixed side 202 is a crescent-shaped side formed by the stitching ear 201 at one end of the leaflet unit 200 along the lower end curve to the other end, and the fixed side is 0.5 to 3 mm wide.

The leaflet unit 200 of the leaflets is evenly distributed in the circumferential direction of the central portion of the sealing film 110.

The stitching manner of the two sealing film unit stitching edges 101 is a ferrule tying manner or a spiral stitching method or a rack stitching method in which two sides are alternately passed or a matrix stitching method or a cross stitching method.

Preferably, the stitching manner of the two sealing film unit stitching edges 101 is a manner in which the ferrule is knotted, and the distance between adjacent two knotting nodes is 1 to 4 mm.

The suture pattern of the leaflet 210 on the sealing film 110 is a rack stitching method or a spiral stitching method or a stitching method along the fixed side matrix or a sawtooth pattern along the fixed leaf edge of the sealing film 110 and the leaflet 210 along the fixed edge 202 of the leaflet unit. Shape stitching or T-stitching.

Preferably, the suture of the leaflet 210 on the sealing membrane 110 is alternately passed between the sealing membrane 110 and the leaflet 210 along the leaflet fixed edge 212 so that each node is T-shaped, and the distance between two adjacent nodes is 1 to 4 mm.

The upper and lower portions of the valve holder 500 are outwardly shaped like a lotus flower, and the central portion of the valve holder 500 is tubular.

The three portions of the valve holder 500 are connected by a rigid vertical rod, wherein the connection between the upper portion and the middle portion is a non-one-to-one uniform distribution, that is, the rigid vertical rod connecting the upper portion and the middle portion is evenly arranged along the circumferential direction of the valve holder 500, the middle portion The full connection with the lower connection is a one-to-one correspondence, that is, the central and lower rigid vertical rods are arranged in one-to-one correspondence between the middle rhomboid and the lower rhomboid, as shown in FIG. 6, that is, the middle portion The rhomboids corresponding to the lower portions are each connected by a rigid vertical rod which helps to improve the compliance of the valve holder 500 in the release position.

The lotus shape at both ends of the sealing film 110 is matched with the lotus shape of the upper and lower portions of the valve holder 500, and both ends of the sealing film 110 are stitched to the valve holder 500 in a one-to-one manner in a wrapped manner.

The suture mode of the prosthetic valve 300 on the valve frame 500 is such that the upper and lower ends are knotted by the ferrule, and the rest of the positions are stitched around the rod in a stepped semi-annular manner along all the rods of the valve holder 500, and the adjacent two half rings The distance is 1 to 5 mm.

The invention is further described below in conjunction with the drawings. The present invention mainly relates to a prosthetic valve, the unique lotus-like structure at both ends of the invention makes the invention more suitable for patients with pulmonary artery enlargement or deformity. The upper end of the prosthetic valve is its blood outflow channel and the lower end is its blood inflow channel.

First Embodiment: As shown in FIG. 1-2, the sealing film 110 in this embodiment is formed by stitching three sealing film units 100 through two stitching edges 101, due to the two ends of the sealing film unit. The crown-like structure is such that the entire sealing film after stitching exhibits a lotus-like shape at both ends and a straight cylindrical structure at the center, and a splicing line 113 is formed. The stitching edge 101 is a recessed groove-like structure, and the upper and

lower edges

111, 112 of the sealing film have a toothed structure. 114 is a boundary line between the straight section of the sealing film and the lotus-shaped section, and a leaflet 210 is disposed between the two boundary lines 114. The reinforcing portion on the sealing film unit 100, that is, the reinforcing ear 102, is designed to increase the strength and stability of the sealing film when it is sewn to the valve frame, and is designed with a matching edge 103 to the valve holder.

The stitching at the seam edge between the sealing film units has a ferrule knotting method or a spiral stitching method or a rack stitching method or a matrix stitching method or a cross stitching method in which two sides are alternately passed, as shown in Fig. 7-14. The quilting of the ferrule is accomplished by using a suture to tie the two stitching edges at each needle point, which makes the connection between the sealing film units more secure. The spiral stitching method is to pass a suture thread from the same direction through the two stitching edges, and the path is substantially a spiral shape. The racking method in which the two sides alternately pass through is that the suture passes through the exposed faces of the two stitching edges in sequence. The matrix stitching method is formed by reciprocating the rack stitching method once. The cross stitching method is formed by spiral stitching once and for all. In the above stitching method, the distance between adjacent two needle insertion points along the stitching edge is 1 to 4 mm.

As shown in FIG. 3-5, the leaflets 210 disposed between the sealing film boundary lines 114 are formed by stitching the three leaflet unit 200 through the stitching ears 201 thereon, forming three stitching ear splicing segments. 211, and the fixed edges of the three leaflet units are spliced to form the leaflet fixed edge 212. The suture ear splice segment 211 and the leaflet fixed edge 212 are the suture path 301 of the leaflet 210 in the sealing film 110, and the prosthetic valve can control the blood flow direction by relying on the free edge 203 of each leaflet unit. The stitching manner of the stitching path 301 is a rack stitching method or a spiral stitching method in which two sides alternately pass through, or a fixed edge matrix stitching method or a zigzag stitching method or a T-shaped stitching manner, as shown in FIG. The rack stitching method, the spiral stitching method, and the stitching along the fixed side matrix are the same as the sealing film stitching manner. The zigzag stitching method is derived from the matrix stitching method, that is, the needle point is alternately shifted up and down. The T-stitching method is formed by alternately passing a suture between the two faces.

As shown in FIG. 5, the leaflet 210 sewn in the sealing film 110 and the upper end of the sealing film (ie, the blood outlet end of the prosthetic valve) form a space with good sealing performance, which can effectively reduce the paravalvular leakage and reflux. .

The second embodiment: as shown in FIG. 6, the artificial valve 300 is installed in the valve holder 500 having the shape memory effect and can be self-expanded to form the artificial valve device 400. The suture method of the artificial valve on the valve frame is The upper and lower ends are the way of ferrule tying, and the rest of the positions are stitched around the rod in a stepped semi-annular manner along all the rods of the bracket (as shown in Fig. 14), and the distance between adjacent two half rings is 1 to 5 mm. Each rod of the valve holder is sewn together with a sealing membrane of the prosthetic valve. The prosthetic valve of the first embodiment uses the prosthetic valve of the first embodiment.

The embodiments described above are only intended to describe the preferred embodiments of the present invention, and are not intended to limit the scope of the present invention, and various embodiments of the present invention may be made by those skilled in the art without departing from the spirit of the invention. Modifications and improvements are intended to fall within the scope of the invention as defined by the appended claims.

Industrial applicability

The prosthetic valve and the prosthetic valve device of the embodiment of the invention suture the leaflets in the interior of the sealing membrane with a bowl-shaped mouth at both ends, and the highest point of the leaflets is lower than the upper edge of the sealing membrane, so that the leaflets are completely wrapped Among the sealing membranes, when the leaflets are closed, the blood returning from the upper end of the prosthetic valve is completely confined in the space formed by the sealing membrane and the closed leaflets, improving the pulmonary valve regurgitation, and the outward lotus at both ends The structure can be applied to lesions of pulmonary artery enlargement or deformity. The leaflet structure of the prosthetic valve conforms to the fluid dynamic structure, and the suture of the prosthetic valve is firm and reliable, improving the safety and effectiveness of use. The prosthetic valve and prosthetic valve device of the embodiments of the present invention can be mass-produced.

Claims

A prosthetic valve comprising: a sealing film and a leaflet, wherein the sealing film has a cylindrical shape, and each of the two ends of the sealing film is provided with an external flare, and the port of the external flare is toothed a structure in which a middle portion of the sealing film has a straight cylindrical shape, an inner diameter of the outer flare is larger than an inner diameter of a middle portion of the sealing film, and the sealing film is sewn by at least three sealing film units, and the leaflets are at least three The leaflet unit is sutured to form an annular structure, and the leaflet is disposed in the middle of the sealing film.
The prosthetic valve according to claim 1, wherein the upper and lower ends of the sealing film unit are respectively inclined outwardly, and the upper and lower ends of the sealing film unit are respectively provided with reinforcing ears, and the reinforcing ear is configured The toothed structure at the outer flare port, the middle portion of the sealing film unit is rectangular, and both sides of the sealing film unit are stitched edges.
The prosthetic valve according to claim 2, wherein the sewn edge penetrates from the upper end of the sealing film unit to the lower end of the sealing film unit.
The prosthetic valve according to claim 3, wherein the sewn side is a groove-like side having a width of 0.5 to 3 mm.
The prosthetic valve according to claim 4, wherein the leaflet unit comprises an upper rectangular shape and a lower rectangular shape, the upper rectangular shape and the lower rectangular shape being connected by respective long sides, the upper rectangular shape The length of the long side is greater than the length of the long side of the lower rectangle, and the two corners of the lower side of the lower rectangle are removed and rounded, and the two short sides of the upper rectangle are the stitching ears, and the edges of the lower rectangle It is a fixed side.
The prosthetic valve according to claim 5, wherein the fixed side has a width of 0.5 to 3 mm.
The prosthetic valve according to claim 6, wherein the leaflet unit of the leaflet is evenly arranged in the circumferential direction of the central portion of the sealing film.
The prosthetic valve according to claim 7, wherein the sealing film is sewn by three sealing film units, and the leaflets are stitched and joined by three leaflet units.
The prosthetic valve according to claim 8, wherein the suturing manner of the suture edges of two adjacent sealing film units is a spiral stitching method or a rack stitching method in which two sides are alternately passed or a matrix stitching method or a cross stitching method. the way.
The prosthetic valve according to claim 9, wherein in the suturing manner of the suture edges of two adjacent sealing film units, the distance between adjacent two needle insertion points along the sewn side is 1 to 4 mm.
The prosthetic valve according to claim 8, wherein the suturing manner of the suture edges of two adjacent sealing film units is a manner in which the ferrule is knotted, and the distance between two adjacent knotting nodes is 1 to 4mm.
The prosthetic valve according to claim 9 or 11, wherein the suture of the leaflet on the sealing membrane is alternately passed between the sealing membrane and the leaflet along the fixed edge of the leaflet unit. Rack stitching or spiral stitching or matrix stitching or zigzag stitching.
The prosthetic valve according to claim 12, wherein in the suturing manner of the leaflets on the sealing film, the distance between adjacent two needle insertion points along the fixed side is 1 to 4 mm.
The prosthetic valve according to claim 9 or 11, wherein the suture of the leaflet on the sealing membrane is alternately passed between the sealing membrane and the leaflet along the fixed edge of the leaflet to make each node It is T-shaped, and the distance between two adjacent nodes is 1 to 4 mm.
The invention relates to a prosthetic valve device, which comprises a prosthetic valve and a valve frame, wherein the valve frame is a lattice structure with lotus flowers at both ends and a straight tube shape in the middle, and the valve frame is upper and middle in order from top to bottom. And the lower part, wherein the upper part and the lower part are in the shape of a lotus flower, and the middle part is in the shape of the straight tube, each part is formed by connecting a plurality of rhomboids, and the artificial valve is any one of claims 1 to 8. In the artificial valve, the outer flares at both ends of the sealing film are respectively matched with the lotus-shaped ends of the valve holder, and the middle portion of the sealing film is matched with the middle portion of the valve holder, and the sealing film Stitched to the inner wall of the valve holder.
The prosthetic valve device according to claim 15, wherein the upper and middle portions of the valve holder and between the middle portion and the lower portion are connected by a rigid vertical rod.
The prosthetic valve device according to claim 16, wherein the rigid vertical rod connecting the upper portion and the middle portion is evenly arranged along the circumferential direction of the valve holder, and the rigid rods connecting the middle portion and the lower portion are in one-to-one correspondence It is arranged between the rhomboid in the middle and the rhomboid in the lower part.
The prosthetic valve device according to claim 17, wherein both ends of the sealing film are respectively sutured in a one-to-one manner at both ends of the valve holder.
The prosthetic valve device according to claim 18, wherein the suture manner of the prosthetic valve on the valve frame is such that the upper and lower ends are knotted by the ferrule, and the remaining positions are along the composition of the valve holder. The rhomboid-shaped rod is stitched around the rod in a stepped semi-annular manner.
The prosthetic valve device according to claim 19, wherein said suture is wound around the rod in a stepped semi-annular manner, and the distance between adjacent two half rings is 1 to 5 mm.