WO2015122636A1

WO2015122636A1 - Prosthetic heart valve and manufacturing method therefor

Info

Publication number: WO2015122636A1
Application number: PCT/KR2015/000834
Authority: WO
Inventors: 신경민; 홍강선
Original assignee: (주) 태웅메디칼; 신경민
Priority date: 2014-02-17
Filing date: 2015-01-27
Publication date: 2015-08-20
Also published as: KR101525921B1

Abstract

The present invention relates to a prosthetic heart valve which maintains the same structure as a human heart valve by a stent made of a metal material having good flexibility, and improves the durability against fatigue due to valve functions and increases tightly supporting force by fitting valve leaflets into elongated holes of the stent without stitching seam portions where the stent and the valve leaflets come in contact with each other, and to a manufacturing method therefor. More specifically, the prosthetic heart valve comprises: a metal stent having three protruding posts, downward curvature ends which are recessed downwardly and are connected between the posts, valve holes which are formed around both sides of an elongated hole formed in the center of each post, and a plurality of stitch holes formed along a cylindrical-shaped body below the valve holes; a fabric inserted into the metal stent, covering the entire outer surface of the metal stent, stitched along the stitch holes, and having cutout holes which are cut so as to communicate with the elongated holes; and three valve leaflets made of bovine pericardium or porcine pericardium and stitched in the inside of the metal stent covered with the fabric while passing stitching thread through the stitch holes, wherein each valve leaflet has a coupling end fitted into the elongated hole, both the distal ends of the coupling end projecting from the elongated hole are stitched to the valve holes, and the remaining part (the upper end of the valve leaflet) is freely located. Accordingly, since seam portions where the stent and the valve leaflets come in contact with each other are not stitched, the present invention has advantages in that a crack or breakage is prevented and durability is improved, compared to a woven type prosthetic heart valve.

Description

Artificial heart valve and its manufacturing method

The present invention relates to an artificial heart valve, and in particular, a flexible metal stent maintains a structure such as a human heart valve, and the fatigue durability due to the valve function is inserted into the stent hole of the stent without being sewn into a joint portion where the valve leaves are in contact with each other. The present invention relates to an artificial heart valve and a method of manufacturing the same, which improves and increases adhesion.

In general, artificial heart valves are used for surgical replacement in the event that a human heart valve is damaged or functionally defective. It is also used to prevent the backflow of blood in the recently developed artificial heart or ventricular assist device.

Artificial heart valves can be divided into mechanical valves, tissue valves, and polymer valves according to the composition of the main material, and the mechanical valves prevent the reverse flow of blood by restricting the movement of circular or semi-circular hinges in one direction to the annular frame. The tissue valve is made of a structure similar to the heart valve of the animal or pericardium surrounding the heart (pericardium) and the aortic valve (pulmonic valve) of the heart (Pulmonic valve). The polymer valve may be used by molding a medical polymer into a form similar to the aortic valve, or may be manufactured in a structure that serves as a one-way check valve.

Here, the structure of the aorta or pulmonary artery valve has three membranes having a flexible structure that prevents blood backflow, thereby preventing blood flow. This is called a trileaflet valve, and conventional tissue valves and polymer valves are mainly manufactured similarly to this type. have.

In addition, the leaflets of the artificial heart valves are similar to the leaflets of the biological heart valves, and durability is an important material selection criterion because they have to operate in the body for a long period of time. In addition, since it is in direct contact with blood, it is necessary to select a material suitable for blood or use a material having added blood compatibility.

Such a conventional trileaflet polymer valve has two steps. First, the parts corresponding to the valve leaf are first manufactured.

This process produces a mold similar to the leaflet (leaflet), immersed in a polymer solution, and then repeated to dry the process to separate the polymer film from the mold to produce a leaflet shape. Next, the method is completed by bonding three valve leaves inside the valve conduit surrounding the manufactured valve leaves. At this time, the valve conduit is advantageous to form a sinus for each valve leaf to minimize the stagnant area of blood when the valve is closed, and the thickness is 2 to 20 times that of the valve leaf in consideration of the aortic thickness in vivo. It may be thick enough and have sufficient strength in vivo.

As described above, the process of manufacturing a conventional trileaflet polymer valve has undergone a process of separately manufacturing and adhering the valve conduit injected with a polymer in a solution state or molded by another method, and the production time takes several days or more, It is difficult to expect a uniform quality because the immersion and bonding process is performed by hand, and the productivity is not high, so it has low practicality.

In order to solve this problem, a stent valve has been proposed as Korean Patent Registration No. 10-0850035.

The stent valve according to the prior art as described above comprises: a) a single radially expanding vessel stent having a diameter, a proximal end and a distal end; b) a valve having a proximal end of the valve and a distal end of the valve and at least partially located within the stent, the valve proximal end defining a valve opening disposed at the proximal end of the stent, the valve of blood At least two bladder structures for preventing flow, the bladder structures disposed within the stent, the bladder structures including a flexible portion cooperating to form a valve opening adjacent the proximal end of the stent, the flexible The gender portion has an outer end connected to the stent and extending inwardly from the stent to form a valve opening, wherein each bag structure includes a layer extending from the nipple of the bag structure toward the proximal end of the stent, wherein The layer is sutured to the inner surface of the stent to cover the inner surface of the stent. That is configured adjacent the distal end of the stent.

Such a stent valve according to the prior art is inserted into the interior of the blood vessel stent so that the two pocket structures to perform the function of the valve is connected to the blood flow in the heart direction but does not escape from the heart, when used for a long time The tearing occurs at the portion where the vessel stent and the pocket structure are connected, and when the elasticity of the pocket structure is extinguished, a problem of losing the function of the valve may occur.

In addition, Korean Patent Application Publication No. 10-2008-0103510 has proposed a stent-valve for valve replacement and related methods and systems for surgery.

Such a valve according to the prior art, such as a valve component (valve) component; And a stent component comprising a first section, a second section for housing the valve component, and a third section, wherein the first section comprises an annular groove.

However, the valve according to the prior art as described above has a problem in that the manufacturing process is complicated by manufacturing in the form of a valve integral, thereby increasing the manufacturing cost, as well as tearing in the connected portion when used in conjunction with the wire stent.

In addition, US patent registration No. 5713953 has been proposed to replace the artificial heart valves aortic valve.

The valve according to the prior art as described above is made of bovine pericardium and sutures the inner sheet consisting of three semicircular forms and the outer sheet made of bovine pericardium and then rolls in a cylindrical shape to suture both ends.

However, the valve according to the prior art as described above had a problem that the tear occurs in the connected portion when used in combination with a separate wire stent.

In addition, the artificial heart valve has been proposed in the Republic of Korea Patent Publication No. 2002-0082217.

The valve according to the prior art as described above has an inner face, an outer face, an inflow edge, an outlet edge, and a side edge, respectively, and is sealed together along at least one portion of the side edge to substantially have an inlet end and an outlet end. To form a tubular valve structure, and the side edges of adjacent leaflets are sufficiently aligned in a straight line so that the inner faces of the electrical leaflets are arranged in engagement with adjacent side edges of each other. The electrical valve structure is thin and flexible that is movable between the closed state where the outflow edges of adjacent leaflets are engaged with each other and the open state apart from each other except for the side edges where the outflow edges of the adjacent leaflets are partially closed with sutures. It comprises a plurality of leaflets.

However, the artificial valve according to the prior art as described above has a problem that the tearing occurs in the portion connected to the metal stent during long time use, and when the elasticity of the valve leaf disappears due to continuous shear stress, the valve function loses its function.

Accordingly, the present invention has been made in view of the problems of the prior art as described above to provide an artificial heart valve and a method for manufacturing the artificial leaf valve to insert the valve leaf in the stent hole of the stent so that the valve leaf is not sewn on the joint portion in contact with each other. have.

In addition, another object of the present invention is to prevent the incision or breakage and improve durability than the weaving method because the seams of the stent and valve leaf are not sewn as a whole.

In addition, another object of the present invention is to wrap the metal stent with a cloth to reduce the heterogeneity with the human tissue, to improve the support, and to block blood leakage.

In addition, another object of the present invention is to form a suture ring on the outer surface of the metal stent by sewing a roll of cloth.

In order to achieve the above object of the present invention, in the artificial valve, between the three protruding post and the post is connected to the lower curvature end recessed downward, the valve is formed around both sides of the long hole formed in the center of the post And a metal stent having a plurality of needle holes formed along a cylindrical body at a lower portion of the valve hole, and inserted into the metal stent to enclose the entire outer surface and sewed along the needle holes. A cloth is formed to form an incision hole to be in communication with each other, and is formed of a small pericardium or a pig pericardium into the inside of the metal stent covered with the cloth. Artificial core, characterized in that it consists of three valve lobes sewn and freely positioned There is provided a valve and a method of manufacturing the same.

As described above, the present invention has an effect of preventing incision or breakage and improving durability than the weaving method by inserting the valve leaf into the stent hole 13 of the stent so that the valve leaf is not sewn to the joint portion in contact with each other.

In addition, there is an effect to remove the heterogeneity with the human tissue and to improve the frictional support to the metal stent with a cloth.

In addition, there is an effect of forming a ring shape on the outer surface of the metal stent by sewing the rolled cloth.

1 is a perspective view showing a metal stent of the artificial heart valve according to the present invention,

Figure 2 is a side view showing a metal stent of the artificial heart valve according to the present invention,

3 is an exploded perspective view of a cloth bonded to a metal stent of an artificial heart valve according to the present invention;

Figure 4 is a perspective view of a cloth stitched on the metal stent of the artificial heart valve according to the present invention,

5 is a perspective view of the suture ring after sewing a cloth to the metal stent of the artificial heart valve according to the present invention,

6 is a cross-sectional view of the stitching portion formed with a cloth and a suture ring on the metal stent of the artificial heart valve according to the present invention;

7 is a perspective view combining the valve leaf after sewing the cloth and suture hook on the metal stent,

8 is a perspective view of cutting the protruding area of the valve leaf and sewing the combined end on the metal stent and cloth to complete the artificial heart valve,

In Figure 9, the cross section sewn with threaded thread through the valve holes, respectively passing through the long hole,

In FIG. 10, a is a block diagram showing three separate leaflets, and b is a block diagram showing an integral valve leaf and two leaf valves integrally connected to each other, and FIG. Diagram showing an integral valve leaf connected by

11 is a cross-sectional view sewn into the weaving thread through the valve hole by pressing the center of the coupling end passing through the long hole,

12 is an operation diagram showing a state in which the blood of the heart is discharged through the aorta through the artificial heart valve,

13 is an operation diagram showing a state in which blood flowing back to the heart through the artificial heart valve is blocked by the valve leaf.

The preferred embodiment of the present invention as described above will be described in detail based on the accompanying drawings.

As shown in FIG. 8, the artificial heart valve of the present invention and a method of manufacturing the same include a metal stent 10 having three posts 11 formed thereon, and a cloth wrapped around the metal stent 10 in the artificial valve. 20, and the artificial heart valve 100 is composed of the valve leaf 30 woven in the inner side of the metal stent 10 is wrapped cloth (20).

As shown in Figure 1 to 9, the artificial heart valve 100 is connected between the three protruding post 11 and the post 11 by a downward curvature end 12 recessed downward, the post A valve hole 14 formed around both sides of the long hole 13 formed at the center of the 11 and a needle hole 16 along the cylindrical body 15 at the lower portion of the valve hole 14 are formed. A plurality of metal stents 10 are formed.

At this time, the body (15) is inclined at an angle of 6 ~ 8 ° inward to the post 11 is formed in the upright arrangement of the plurality of valve holes 14 in the periphery on both sides of the vertically formed long hole 13 in the center to the top It protrudes and is formed.

Here, the reason why the post 11 is tilted 6 to 8 ° inwardly is to increase the adhesion between the valve leaves 30 when they are combined and to disperse the concentration of repetitive stress generated during the operation of the valve function and to reduce the degree of fatigue. To reduce.

The lower end where the post 11 is positioned forms an upward curvature stage 17 recessed upward.

In addition, between the downward curvature stage 12 and the upward curvature stage 17, a plurality of needle holes 16 are formed along the body 15 in a citron arrangement.

Here, the needle hole 16 is configured in a pair at both ends, the metal stent 10 is configured in the form of a crown.

Meanwhile, the fabric 20 is inserted into the metal stent 10 to cover the entire outer surface and sewed along the needle hole 16, and cut to communicate with the long hole 13 to form the cut hole 21. To form.

Here, the cloth 20 may be divided into an upper end 20b wrapped downward through an upper portion of the metal stent 10 and a lower end 20a wrapped upward through a lower portion, and the upper and lower ends ( 20b) 20a are brought into contact with each other at the positions where the sewing holes 16 are formed, and then stitched along the sewing holes 16 using sewing threads to connect with the metal stent 10.

At this time, the lower end of the extra fabric 20 remaining after wrapping the metal stent 10 forms a suture ring 22 which is rolled in a ring shape and is positioned below the outer circumferential surface of the metal stent 10.

The suture ring 22 may be formed by inserting a shape yarn 23 made of the same material as the cloth 20 in a ring shape or by inserting a silicon ring 24.

In addition, the suture ring 22 is located in the lower portion is woven with the sewing hole 16 by the sewing thread, the upper portion of the suture ring 22 is a cloth 20 to wrap the outer surface of the metal stent 10 with a needle thread. ) And connect them in a circle.

Such, the suture ring 22 is configured to perform the function to support the artificial heart valve 100 is not detached when the installation using the lumen and the suture of the aorta, the formation position is a sewing hole ( 16 is installed close to the center portion of the metal stent 10 is described as an example in the present invention, but the position of the suture ring 22 may be formed at the lower end or the upper side of the metal stent 10. have.

That is, when the formation position of the suture ring 22 is located at the center or the upper side of the metal stent 10, the end of the metal stent 10 may be partially inserted into the contraction portion of the cardiac aorta and then operated. If the position of the suture loop 22 is the end of the metal stent 10, the suture ring 22 is configured to be treated at the entrance of the contraction portion of the heart aorta.

On the other hand, the cloth 20 is formed of a small pericardium or pig pericardium into the inner side of the metal stent 10 is covered with a sewing thread through the sewing hole 16 and sewn and passed through the long hole 13 and the incision hole 21 The coupling end 32 is sewn into the valve hole 14 and the remaining part consists of three valve leaves 30 freely located.

This, the valve leaf 30 is a pair of protruding outward to be sewn in the opposite valve hole 14 through the long hole 13 and the incision hole 21 at both ends of the rectangular valve body 31 Combination end of the 32 is formed in a 'tt' shape.

As another embodiment, as shown in FIGS. 10 and 11, the valve leaf 30 has two valve blades 30 side by side and the coupling end 32 facing each other is integrally connected to form a 'ㅠ' shape. It may be configured as an integral valve leaf 30, wherein the integrated valve leaf 30 is configured in a pair with a general valve leaf 30.

In yet another embodiment, the valve leaf 30 is connected to the coupling end 32 facing each other with the three valve leaf 30 side by side as a '일체' shaped integral valve leaf 33 It can also be configured.

That is, the integral valve leaf 30 has a convenience in manufacturing and passes through the long hole 13 and the incision hole 21 in a state in which the coupling ends 32 connected to each other are bilaterally folded and then folded at the combined ends ( Both ends pressurizing 32 to form a 'T' are sewn into the valve hole 14 and the remaining parts constitute three valve leaves 30 which are freely positioned.

At this time, the lower end protruding to the lower bend end 12 and the lower bend end 17 of the body 15 of the valve leaf 30 exposed to the lower portion of the metal stent 10 is covered with the cloth (20) It is configured by cutting.

Subsequently, the end of the upper end 20b of the remaining cloth 20 after wrapping the metal stent 10 is lifted upward to surround the metal stent 10 and then removed along the downward bend end 12, and then the metal stent 10 is sewn with thread. ) To be sewn with a cloth (20) surrounding.

Referring to the operation and effects of the present invention configured as described above are as follows.

As shown in Figures 1 to 9, 12 and 13, the artificial heart valve 100 is inserted into the inner and outer surface of the metal stent 10 formed in the center of the three protruding post (11) To be wrapped with a cloth 20, the cloth 20 is divided into an upper end (20b) wrapped to the bottom through the top of the metal stent 10 and a lower end (20a) wrapped to the upper through the bottom, The upper and lower ends 20b and 20a are brought into contact with each other at the positions where the sewing holes 16 are formed, and then stitched along the sewing holes 16 using sewing threads to connect with the metal stent 10.

Here, the fabric 20 is sewn with a sewing thread while being pulled in close contact with the post 11 and the upper and lower curvature ends 12, 17 of the metal stent 10, the needle hole 16 at both ends It is composed of a pair is characterized in that the area of the metal stent 10 is tightly connected in the wide body 15 to prevent the movement phenomenon.

At this time, the sewing thread for sewing the metal stent 10 and the cloth 20 is harmless to the human body and passed through the outer and the inner side of the needle hole 16 with two sewing threads, weaving so that the shape of the sewing thread is eight characters. do.

Thereafter, the cloth 20 is cut to form a cutting hole 21 communicating with the long hole 13 formed in the post 11.

Here, the incision hole 21 is cut to form a size that can pass in the state in which the coupling end 32 of the valve leaf 30 overlaps two.

Next, the two ends of the three valve leaf 30 through each of the incision hole 21, the long hole 13, the incision hole 21 to be in close contact with the fabric 20 to both sides and then to the fabric 20 and The valve hole 14 and sewn together to form an X-shaped connection.

That is, the valve leaf 30 is exposed to the outside through the incision hole 21 in the state in which the coupling end 32 of the adjacent valve leaf 30 is in close contact with each other, each coupling end 32 is mutually Spread in the opposite direction and close to the cloth 20 is to weave through the coupling end 32 and the cloth 20 through the valve hole 14 to connect in the order of the cloth 20 by using a sewing thread.

Subsequently, the valve body 31 of the valve leaf 30 is formed in a quadrangular shape so as to pass through the downward curvature end 12 and the upward curvature end 17 of the metal stent 10. Is cut along the shapes of the down curvature stage 12 and the up curvature stage 17.

Subsequently, the lower end of the valve body 31 of the valve leaf 20 is sewn together with a fabric 20 surrounding the down curvature end 12 and the up curvature end 17 using a sewing thread to be fixed in an elliptical shape. As a result, the upper ends of the three valve leaves 20 can be in contact with each other (occlusal), thereby closely blocking the leakage of blood.

That is, the valve leaf 30 is characterized by increasing the durability of the valve body 31 that operates only to the coupling end 32 to the metal stent 10 and the sewing thread to perform the function of the valve.

Subsequently, the lower end of the excess fabric 20 remaining after wrapping the metal stent 10 forms a suture ring 22 positioned below the outer circumferential surface of the metal stent 10 in a ring shape, and then the suture ring ( 22 is fixed to the lower portion is sewn into the threaded portion of the sewing hole 16 and the sewing loop, the upper portion of the suture ring 22 is interwoven with a cloth 20 surrounding the outer surface of the metal stent 10 with a needle thread. Connect to form a circle.

In addition, the interior of the suture ring 22 is characterized in that the shape of the suture ring 22 by inserting the form yarn 23 made of the same material as the cloth 20 in the form of a ring or by inserting a silicon ring 24. In this case, the suture ring 22 is characterized by having a function to complete the manufacture of the artificial heart valve 100, without slipping in the lumen of the blood vessels without slipping during the procedure.

Next, the upper end 20b of the excess fabric 20 remaining after wrapping the metal stent 10 is wrapped around the metal stent 10 on which the cloth 20 is wrapped and the upper end 20b of the remaining fabric 20. ) End is removed by the upper bend end 12 to wrap up the metal stent 10 and then sewn with a cloth 20 surrounding the metal stent 10 with a sewing thread.

That is, since the finishing ends wrapped with cloth 20 without exposing the coupling end 32 of the valve leaf 30 to the outside, the coupling end 32 is prevented from coming into contact with the lumen of the human body.

Thus, the completed artificial heart valve 100 is inserted into the aorta (200) connected to the heart lumen and then connect the suture ring 22 and the lumen inner wall with a suture, the post 11 is the blood is discharged to flow Facing upwards, the upward curvature stage 17 is inserted facing the heart side.

Thereafter, the suture ring 22 and the inner wall of the blood vessel of the aorta are laced together using a suture to complete the procedure of the artificial heart valve 100.

In this way, the artificial heart valve 100 is completed, the upper portion of the valve body 31 of the valve leaf 30 is not connected to the metal stent 10 and the sewing thread 25 is less fatigue for the valve action It does not cause cracks or breakage and has a feature that can be used for a long time.

In the above, the present invention has been illustrated and described with reference to specific preferred embodiments, but the present invention is not limited to the above-described embodiments and is not limited to the spirit of the present invention. Various changes and modifications can be made by those who have

10: metal stent 11: post

12: downward curvature stage 13: long hole

14 valve hole 15 body

16: needle hole 17: the upper curvature stage

20: cloth 21: incision hole

22: suture ring 23: morph yarn

24: silicone ring 25: sewing thread

30: valve leaf 30a: protruding area

31: valve body 32: coupling end

33: integral valve leaf 100: artificial heart valve

200: aorta

Claims

In artificial valve,

Between the three protruding post 11 and the post 11 is connected to the downward curvature end 12 recessed downward, the valve formed around both sides of the long hole 13 formed in the center of the post 11 A hole 14 and a metal stent 10 having a plurality of needle-holes 16 formed along the cylindrical body 15 at the lower portion of the valve hole 14,

It is inserted into the inside of the metal stent (10) is wrapped around the entire outer surface of the needle hole (16), and forms a cloth (20) formed with a cutting hole 21 is cut to communicate with the long hole (13) ,

The inner end of the metal stent 10 covered with the cloth 20 is formed as a small pericardium or porcine pericardium and stitched through the sewing hole 16 with a sewing thread and passed through the long hole 13 and the incision hole 21. An artificial heart valve, characterized in that (32) is sewn into the valve hole (14) and the remaining part consists of three valve lobes (30) freely located.
According to claim 1, wherein the body (15) has a post hole (11) formed in the upright arrangement of the plurality of valve holes 14 in the periphery on both sides of the longitudinally formed in the center (13) in the center 6 to 8 ° It is inclined to protrude upwards,

The lower end where the post 11 is located forms an upward curvature stage 17 recessed upwardly,

An artificial heart valve, comprising a plurality of needle-holes 16 in a citron arrangement along the body 15 between the downward curvature stage 12 and the upward curvature stage 17.
3. The heart valve of claim 2, wherein the needle holes (16) comprise a pair at both ends.
According to claim 1, wherein the valve leaf 30 is passed through the long hole 13 and the incision hole 21 at both ends of the rectangular valve body 31 to the outside to be sewn in the opposite valve hole 14 Artificial heart valve, characterized in that configured to form a 'TT' formed with a pair of protruding coupling end (32).
The artificial heart valve according to claim 1, characterized in that the lower end of the body (15) of the valve leaf (30) exposed to the lower portion of the metal stent (10) on which the cloth (20) is covered is cut.
According to claim 1, wherein the lower end (20a) of the extra fabric 20 remaining after wrapping the metal stent (10) is formed in a ring-shaped suture ring 22 which is located in the lower peripheral surface of the metal stent (10) and,

The end of the upper end (20b) of the remaining cloth 20 after wrapping the metal stent 10 is raised to the top to surround the metal stent (10) and removed according to the downward bend end 12, and then the metal stent (10) with a sewing thread Artificial heart valve, characterized in that configured to be sewn with a cloth 20.
The method of claim 6, wherein the interior of the suture ring 22 is formed by inserting a shape yarn 23 made of the same material as the cloth 20 in the form of a ring or by inserting a silicone ring 24. Heart valves.
The method of claim 6 or 7, wherein the suture ring 22 is located in the lower portion of the sewing thread 16 and the interwoven with the sewing hole 16, the upper portion of the suture ring 22 is a stent thread metal stent (10) Artificial heart valve, characterized in that to connect to form a circular weave cloth (20) surrounding the outer surface of the.
In the manufacturing method of artificial valve,

After inserting the inner side and the outer surface of the metal stent 10 formed in the center of the three protruding post 11 to wrap the inner and outer surfaces with a cloth 20, the needle hole formed in the body 15 of the metal stent 10 I sew the upper and lower parts of the cloth 20 located at (16), respectively,

The fabric 20 is cut to form an incision hole 21 in communication with the long hole 13 formed in the post 11,

Pass the coupling ends 32 of the three valve leaves 30 in the order of the incision hole 21, the long hole 13, and the incision hole 21, respectively, closely contacting the cloth 20 to both sides, and then the cloth 20. A method for manufacturing an artificial heart valve, characterized in that the stitched in the valve hole (14) together.
According to claim 9, The body 15 has a post hole 11 formed in the upright arrangement of the plurality of valve holes 14 in the periphery on both sides of the longitudinally formed long hole 13 in the center 6 to 8 ° inwards It is inclined to protrude upwards,

The lower end where the post 11 is located forms an upward curvature stage 17 recessed upwardly,

Method for producing an artificial heart valve between the downward curvature end (12) and the upward curvature end (17) comprises a plurality of needle holes (16) in the citron arrangement along the body (15).
11. The method of claim 10 wherein the needle hole (16) is a method for manufacturing an artificial heart valve, characterized in that composed of a pair at both ends.
10. The valve leaf 30 of claim 9, wherein the valve leaf 30 passes through the long hole 13 and the incision hole 21 at both upper ends of the rectangular valve body 31 so as to be sewn into opposite valve holes 14 in opposite directions. Method of manufacturing an artificial heart valve, characterized in that configured to form a 'TT' formed with a pair of protruding coupling end (32).
10. The method according to claim 9, wherein the lower end of the body (15) of the valve leaf (30) exposed to the lower portion of the metal stent (10) on which the cloth (20) is covered is cut and configured.
10. The method of claim 9, wherein the lower end (20a) of the extra fabric 20 remaining after wrapping the metal stent (10) is formed in a ring-shaped suture ring (22) located in the lower peripheral surface of the metal stent (10) and,

The end of the upper end (20b) of the remaining cloth 20 after wrapping the metal stent 10 is raised to the top to surround the metal stent (10) and removed according to the downward bend end 12, and then the metal stent (10) with a sewing thread Method for producing an artificial heart valve, characterized in that the fabric to be wrapped and sewn (20).
10. The method of claim 9, wherein the interior of the suture ring 22 is formed by inserting a shape yarn 23 made of the same material as the cloth 20 in the form of a ring or by inserting a silicone ring 24. Heart valve manufacturing method.
The method of claim 14 or 15, wherein the suture ring 22 is connected to the lower thread through the sewing hole 16 with a sewing thread, the upper portion of the suture ring 22 is a needle thread of the metal stent (10) Artificial heart valve manufacturing method, characterized in that the connection to form a circular weave cloth (20) surrounding the outer surface.
According to claim 1 or 4, The valve leaf 30 is the coupling end (32) facing each other with two valve leaves 30 side by side integrally connected '?' Shape or three valve leaves ( 30) side by side coupled to each other coupling end 32 is an artificial heart valve, characterized in that consisting of the integral valve leaf 33 of the '┬┬┬' shape.
According to claim 9 or 12, wherein the valve leaf 30 is the coupling end 32 facing each other with two valve leaf 30 side by side connected integrally '?' Shape or three valve leaf ( 30) side by side coupling ends facing each other, the artificial heart valve manufacturing method, characterized in that the integral valve leaf 33 of the '┬┬┬' configuration by connecting integrally.