A valve

Abstract

This application discloses a valve comprising a valve frame, a valve seat, valve leaflets, and a suture ring. The suture ring includes an annular body connected to the valve seat frame. A suture edge for connection with the human body is fixed on the annular body. The suture edge is closedly connected to the valve seat frame. The suture edge is a closed, flexible annular body, and the suture edge and valve leaflets are located on the same side of the annular body. This application improves the compatibility of the valve with the recipient's heart during use, and is primarily applicable to mitral valve replacement surgery, addressing mitral valve and aortic septal stenosis, and better resolving mitral valve replacement-induced aortic regurgitation and stenosis replacement problems. It is especially suitable for individuals aged 0-15 years, as the morphology of the replaced valve does not change with human growth.

Description

Technical Field

[0001] The present application relates to the field of artificial heart valves, and in particular to a valve. Background Art

[0002] The human heart has four valves that control the direction of blood flow. The aortic valve and mitral valve are located on the left side of the heart, controlling the flow of oxygen-rich arterial blood from the lungs to the whole body. The pulmonary valve and tricuspid valve are located on the right side of the heart, controlling the flow of arterial blood with very little oxygen from the whole body back to the lungs. The aortic valve is located between the left ventricle and the aorta, and the pulmonary valve is located between the right ventricle and the pulmonary artery, preventing blood from flowing back from the ventricle. The mitral valve and tricuspid valve are located between the atria and ventricles, preventing blood flowing into the ventricles from flowing back into the atria.

[0003] The left ventricle is the main chamber of the heart that supplies blood to the whole body, so dysfunction of the aortic valve and mitral valve on the left side of the heart is often more serious than that caused by the other two valves. When a patient's heart valve is pathologically narrowed, the valve cannot open normally, or is incompletely closed, the valve does not close completely, causing blood to flow back. Both situations will increase the burden on the heart and accelerate heart failure. There are generally two treatment options: one is to repair the original valve while retaining it, and the other is to replace the original diseased valve with an artificial heart valve.

[0004] There are two basic types of artificial heart valves: mechanical valves with a long service life and biological valves made of biological tissue materials. The basic structure of an artificial heart valve includes a valve frame, a valve seat, a valve leaflet and a sewing ring. The sewing ring is the part that sews the artificial valve to the human heart valve ring, and is now made of knitted materials; the valve seat and valve frame are now basically made of stainless steel, titanium, cobalt-nickel alloy or other superhard metals to provide rigid support for the valve leaflet.

[0005] Reference Figure 1 and Figure 2 , the mitral valve 13 is located between the left atrium 11 and the left ventricle 12. When the mitral valve 13 is diseased, an artificial valve needs to be implanted. Three valve frames are connected to the valve seat of the artificial valve. Each valve frame is provided with a valve angle at one end away from the valve seat. The valve angle and the outer side of the valve frame are wrapped with fibers for connection. The portion indicated by the valve frame 4 in the figure is the valve frame 4 wrapped with fibers. The valve frame 4 is a V-shaped frame with its opening facing the valve seat. Leaflets 5 are arranged in pairs between the valve frames. The valve seat is wrapped with a suture ring 2. Only the wrapped suture ring 2 can be shown in the figure, and the valve seat cannot be shown. When the leaflets 5 are in use, the three leaf angles on the valve seat 3 are inserted into the left ventricle 12 from the left atrium 11, and then the suture ring 2 is sutured to the tissue part of the mitral valve 13 to achieve a fixed connection between the artificial valve and the human tissue.

[0006] The above-mentioned prior art solutions have the following defects: Figure 3, some patients have a smaller left ventricle 12. After the valve frame 4 is inserted from the left atrium 11 into the left ventricle 12, there is a risk that the valve corners on the valve frame 4 will contact with the ventricular tissue, causing damage to the ventricular tissue; some patients have a slightly smaller annular space for accommodating the valve corners at the mitral valve position, while the valve seat and the valve frame have a fixed diameter, so the three valve corners cannot be completely passed through the annular space of the mitral valve, making it difficult to sew the suture ring 2 and the mitral valve; after the suture ring 2 is sutured with human tissue, since the suture ring 2 is rigidly connected to the valve seat, if the patient's heart continues to grow, the tissue at the mitral valve is connected to the suture ring 2, and tissue growth is hindered, posing a safety hazard to the patient; some patients have hardened tissue at the mitral valve position, and it is difficult to sew the suture ring 2 with the mitral valve tissue.

[0007] At the same time, clinical observations have found that the shape of a normal mitral valve is saddle-shaped when contracted and flat when relaxed. When the suture ring of the artificial valve is directly connected to the tissue near the mitral valve, the rigid frame on the valve seat will always maintain a stable flat shape. Summary of the invention

[0008] The purpose of the present application is to provide a valve which has the effect of improving the compatibility of the valve with the recipient's heart during use.

[0009] The above technical objectives of this application are achieved through the following technical solutions:

[0010] A valve comprises a valve frame, a valve seat, a valve leaflet and a sewing ring, wherein the valve frame, the valve seat and the valve leaflet are connected to each other, and the sewing ring comprises a ring body connected to the valve seat, and a sewing edge fixed to the ring body for connecting to human tissue;

[0011] The connection between the suture edge and the valve seat is closed, and the suture edge is a closed flexible ring.

[0012] By adopting the above technical solution, the end of the flexible suture edge away from the ring body is connected to the tissue near the mitral valve. At this time, the suture edge is located in the atrium, and the part of the valve angle of the valve seat extends into the left ventricle. At this time, the length of the valve angle of the valve seat extending into the left ventricle can be significantly reduced, reducing the risk of the valve angle on the valve seat contacting the ventricular tissue and causing damage to the ventricular tissue.

[0013] Since only a portion of the valve seat's petal angle extends into the left ventricle, even if the annular space at the patient's mitral valve position that accommodates the insertion of three petal angles is slightly smaller, the end of the valve seat's petal angle away from the frame can still be inserted into the annular space at the mitral valve position, thereby ensuring the use of the valve seat;

[0014] At the same time, even if the patient's heart continues to grow, the flexible suture edge has a certain degree of ductility, reducing the impact of the suture edge on the growth of heart tissue;

[0015] Even if the tissue near the patient's mitral valve hardens, the doctor can still sew the suture edge to the rest of the patient's left atrium;

[0016] The flexible suture edge can deform according to tissue deformation when the heart contracts, and adapt to the normal state of human tissue.

[0017] Optionally, the distance from one end of the suture edge away from the ring body to the ring body is smaller than the maximum distance from the leaflet to the ring body.

[0018] Optionally, the suture edge is a circular ring.

[0019] By adopting the above technical solution, the circular suture edge is easy to produce and process, thereby reducing production costs; when the patient's heart grows, the valve moves away from the original leaflet point, ensuring that the valve is stable in the left atrium.

[0020] Optionally, the outer diameter of the suture edge is the outer diameter of the suture ring.

[0021] Optionally, the inner diameter of the end of the suture edge away from the ring body is larger than the inner diameter of the connecting end of the suture edge and the ring body.

[0022] By adopting the above technical solution, the inner diameter of the suture edge away from the end of the ring body is larger, which is convenient for suturing the suture edge with tissue; at the same time, the ductility of the suture edge is improved, which is convenient for suturing with other tissues of the left atrium.

[0023] Optionally, a connecting flange is provided on the outer side of one end of the suture edge away from the ring body.

[0024] By adopting the above technical solution, the connection flange is convenient for medical staff to perform suturing operations and determine the width of the connection flange.

[0025] Optionally, the suture edge and the ring body are connected by fibers made of polyethylene terephthalate.

[0026] By adopting the above technical solution, the suture edge and the ring body are sutured and connected by fibers that do not have a rejection reaction with the human body.

[0027] Optionally, the valve leaflets are bioprosthetic valves.

[0028] By adopting the above technical solutions, artificial bioprosthetic valves are more suitable for use by teenagers.

[0029] A valve comprises a valve frame, a valve seat, a valve leaflet and a suture ring. The valve frame, the valve seat and the valve leaflet are connected to each other. The suture ring comprises a suture edge. The connection between the suture edge and the valve seat is closed. The suture edge is used to connect to human tissue and is a closed flexible ring.

[0030] By adopting the above technical solution, based on most of the current valve seat materials, the frame of the valve seat needs to be wrapped. When the valve seat material does not need to be wrapped, the suture edge can be directly fixed to the frame of the valve seat to use the valve.

[0031] Optionally, the suture edge is detachably connected to the valve frame.

[0032] By adopting the above technical solution, when using leaflets of biological tissue, the leaflets need to be replaced regularly. If the valve is replaced directly, the suture edge needs to be sutured to the human tissue again. Through the detachable connection between the suture edge and the valve seat, the valve seat and the leaflets can be directly replaced, and then the valve seat and the suture edge can be connected, thereby reducing the operation of suturing the suture edge and the human body.

[0033] In summary, the beneficial effects of this application are:

[0034] 1. Connect the end of the flexible suture edge away from the ring body to the tissue near the mitral valve. At this time, the suture edge is located in the atrium, and the part of the valve angle of the valve seat extends into the left ventricle. At this time, the length of the valve angle of the valve seat extending into the left ventricle can be significantly reduced, reducing the risk of the valve angle on the valve seat contacting the ventricular tissue and causing damage to the ventricular tissue;

[0035] Since only a portion of the valve seat's petal angle extends into the left ventricle, even if the annular space at the patient's mitral valve position that accommodates the insertion of three petal angles is slightly smaller, the end of the valve seat's petal angle away from the frame can still be inserted into the annular space at the mitral valve position, thereby ensuring the use of the valve seat;

[0036] At the same time, even if the patient's heart continues to grow, the flexible suture edge has a certain degree of ductility, reducing the impact of the suture edge on the growth of heart tissue;

[0037] Even if the tissue near the patient's mitral valve hardens, the doctor can still sew the suture edge to the rest of the patient's left atrium;

[0038] The flexible suture edge can deform according to the deformation of the tissue when the heart contracts, and it can fit into the normal state of human tissue;

[0039] It is mainly suitable for mitral valve replacement surgery to solve the stenosis of the mitral valve and aortic septum, and better solve the problem of aortic regurgitation and stenosis replacement caused by mitral valve replacement. It is especially suitable for people under 0-15 years old, and the shape of the replaced valve will not change as the human body grows. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 It is a schematic diagram of the structural relationship between the left atrium, left ventricle and mitral valve;

[0041] Figure 2 It is a schematic diagram of the structure of an artificial valve in the prior art;

[0042] Figure 3 It is a schematic diagram of an artificial valve placed in the left atrium and left ventricle in the prior art;

[0043] Figure 4 is a schematic diagram of the overall structure of the first embodiment;

[0044] Figure 5 is a cross-sectional structural schematic diagram showing the connection relationship between the valve seat and the sewing ring in the first embodiment;

[0045] Figure 6 is a cross-sectional structural schematic diagram showing the connection relationship between the valve seat and the sewing ring in the second embodiment;

[0046] Figure 7 It is a schematic cross-sectional structure diagram showing the connection relationship between the valve seat and the sewing ring in the fourth embodiment.

[0047] In the figure, 11, left atrium; 12, left ventricle; 13, mitral valve; 2, suture ring; 21, ring body; 22, suture edge; 23, connecting flange; 3, valve seat; 4, valve frame; 5, valve leaflet. DETAILED DESCRIPTION

[0048] The present application is further described in detail below in conjunction with the accompanying drawings.

[0049] Embodiment 1

[0050] Reference Figure 4 and Figure 5 , the present application discloses a valve, including a valve seat 3, a valve frame 4, a valve leaflet 5 and a suture ring 2. The valve seat 3 is a valve seat structure made of existing titanium alloy metal materials, the valve seat 3 is a circular ring structure, the valve frame 4 is a V-shaped opening facing the valve seat 3, the valve frame 4 is provided with three valves evenly distributed along the circumference of the valve seat 3, the end of the valve frame 4 facing away from the valve seat 3 is provided with a valve angle, the valve angle is a triangular sleeve body sleeved on the outside of the end of the valve frame 4 facing away from the valve seat 3, the valve frame 4, the valve angle and the valve seat 3 are wrapped with a sutured fiber layer on the outside for connection and fixation, the fiber layer is a fiber connection made of polyethylene terephthalate, for the convenience of illustration, the valve frame 4 is shown as a triangular entity in the drawings, the valve frame 4 and the valve angle are shown as a whole, and are not distinguished from the limiting layer wrapped on the outside, the outer side of the fiber layer included in the valve frame 4 is surrounded by a truncated cone structure, and the present application does not make improvements to the existing valve frame 4 and the valve angle. The valve leaflet 5 is an existing artificial biological valve. In another embodiment, the leaflet 5 is a mechanical membrane.

[0051] The material of the sewing ring 2 is an existing material, and in this embodiment, it is polytetrafluoroethylene and polyester filament fabric. The sewing ring 2 includes a ring body 21 and a sewing edge 22. The ring body 21 is connected to the valve seat 3, and the ring body 21 wraps the valve seat 3. The ring body 21 is fixed with a sewing edge 22 for connecting with the human body. In this embodiment, the sewing edge 22 and the ring body 21 are integrally formed to achieve a closed connection between the sewing edge 22 and the valve seat 3. Here, closed means that the blood can be blocked from flowing and penetrating.

[0052] The suture edge 22 is a closed flexible ring. Here, closed means that the blood can be blocked from flowing and penetrating. The suture edge 22 and the valve leaf 5 are located on the same side of the ring body 21. In another embodiment, the suture edge 22 and the valve leaf 5 are respectively located on both sides of the ring body 21. The suture edge 22 is a circular ring. The outer diameter of the suture edge 22 is equal to the outer diameter of the ring body 21. The outer diameter of the ring body 21 is the maximum diameter of the outer side of the suture edge 22.

[0053] In another embodiment, the suture edge 22 is a truncated cone-shaped shell, and the inner diameter of the suture edge 22 gradually increases in the direction away from the ring body 21, so that the inner diameter of the suture edge 22 at the end away from the ring body 21 is larger than the inner diameter of the end connecting the ring edge and the ring body 21. The inner diameter of the suture edge 22 at the end away from the ring body 21 is larger, which is convenient for suturing the suture edge 22 with tissues, and at the same time, the ductility of the suture edge 22 is improved, which is convenient for suturing with other tissues of the left atrium 11.

[0054] In this embodiment, the distance from the end of the suture edge 22 away from the ring body 21 to the ring body 21 is less than the maximum distance from the leaflets 5 to the ring body 21, and is also less than the minimum distance from the valve frame 4 to the ring body 21. In another embodiment, the distance from the end of the suture edge 22 away from the ring body 21 to the ring body 21 is equal to the maximum distance from the leaflets 5 to the ring body 21. In another embodiment, the distance from the end of the suture edge 22 away from the ring body 21 to the ring body 21 is greater than the maximum distance from the leaflets 5 to the ring body 21, and is also greater than the minimum distance from the valve frame 4 to the ring body 21. When in use, the suture edge 22 can be cut according to surgical needs.

[0055] The implementation principle of the above embodiment is:

[0056] The end of the flexible suture edge 22 away from the ring body 21 is connected to the tissue near the mitral valve 13. At this time, the suture edge 22 is located in the left atrium 11, and the valve seat 3 partially extends into the left ventricle 12. At this time, the length of the valve frame 4 extending into the left ventricle 12 can be significantly reduced, reducing the risk of the valve angle of the valve frame 4 contacting the ventricular tissue and causing damage to the ventricular tissue;

[0057] Since the valve frame 4 only partially extends into the left ventricle 12, even if the annular space at the position of the patient's mitral valve 13 that accommodates three valve frames 4 is slightly smaller, the end of the valve frame 4 away from the frame body can still be inserted into the annular space at the position of the mitral valve 13, thereby ensuring the use of the valve seat 3;

[0058] At the same time, even if the patient's heart continues to grow, the flexible suture edge 22 has a certain degree of ductility, reducing the influence of the suture edge 22 on the growth of heart tissue;

[0059] Even if the tissue near the patient's mitral valve 13 is hardened, the doctor can still sew the suture edge 22 to the remaining tissue of the patient's left atrium 11;

[0060] The flexible suture edge 22 can be deformed according to tissue deformation when the heart contracts, and is closer to the normal state of human tissue.

[0061] Embodiment 2

[0062] Reference Figure 6 , a valve, which is different from the embodiment 1 in that a connecting flange 23 is integrally provided at one end of the suture edge 22 away from the ring body 21, and the overall shape of the connecting flange 23 is a circular ring with the same shape as the suture edge 22, and the connecting flange 23 is located outside the suture edge 22. The cross section of the connecting flange 23 in this embodiment is a semicircular flange formed by folding the suture edge 22 outward and contacting and suturing the outer side of the suture edge 22. In another embodiment, the connecting flange 23 is a flange with a rectangular cross section. The connecting flange 23 can facilitate the suturing operation of medical staff and facilitate the medical staff to determine the width of the connecting flange 23.

[0063] Embodiment 3

[0064] A valve, which is different from Example 1 in that a support bar with a certain rigidity is fixed on the valve seat 3, the support bar is not shown in the accompanying drawings, the material of the support bar is the same as that of the valve seat 3, the connection between the support bar and the valve seat 3 can produce stable bending deformation after being subjected to force, the support bar is connected and fixed to the suture edge 22, the suture edge 22 completely wraps the support bar, and the length of the support bar is less than the length of the suture edge 22, and three support bars are evenly distributed along the circumference of the valve seat 3.

[0065] The support strip can support the suture edge 22 . When the patient's heart grows, the end of the support strip away from the valve seat 3 can expand to a certain extent, thereby ensuring that the suture edge 22 is stable in the left atrium 11 .

[0066] Embodiment 4

[0067] Reference Figure 7 , a valve, which is different from the second embodiment in that the suture ring 2 includes a suture edge 22 which is closed and connected to the valve seat 3, and the end of the suture edge 22 away from the frame of the valve seat 3 is used for connecting with human tissue.

[0068] The implementation principle of the above embodiment is:

[0069] When the material of the valve seat 3 does not need to be wrapped, the suture edge 22 can be directly fixed to the frame of the valve seat 3 to use the valve.

[0070] Embodiment 5

[0071] A valve, which is different from the fourth embodiment in that the suture edge 22 is detachably connected to the valve seat 3, and the valve seat 3 includes an upper frame body connected to the valve frame 4 and a lower frame body detachably connected to the upper frame body, and the upper frame body and the lower frame body are both annular frames, and the upper frame body and the lower frame body are snap-connected. After placing one end of the suture edge 22 between the upper frame body and the lower frame body, the upper frame body and the lower frame body are snap-connected to achieve a detachable connection between the frame body and the suture edge 22.

[0072] When using leaflets 5 of biological tissue, the leaflets 5 need to be replaced regularly. If the valve is replaced directly, the suture edge 22 needs to be sutured to the human tissue again. Through the detachable connection between the suture edge 22 and the valve seat 3, the valve seat 3 and the leaflets 5 can be directly replaced, and then the valve seat 3 is connected to the suture edge 22, which reduces the operation of suturing the suture edge 22 and the human body.

[0073] This specific embodiment is merely an explanation of the present application and is not a limitation of the present application. After reading this specification, those skilled in the art may make modifications to the present embodiment without any creative contribution as needed, but such modifications are protected by the patent law as long as they are within the scope of the claims of the present application.

Claims

1. A valve, characterized in that: The invention comprises a valve frame (4), a valve seat (3), a valve leaflet (5) and a suture ring (2), wherein the valve frame (4), the valve seat (3) and the valve leaflet (5) are connected to each other, the valve frame (4) comprises a truncated cone structure surrounded by the outer side of a fiber layer, and the suture ring (2) comprises a ring body (21) connected to the valve seat (3) and a suture edge (22) fixed to the ring body (21) for connecting to human tissue; The connection between the suture edge (22) and the valve seat (3) is closed, and the suture edge (22) is a closed flexible ring; The outer diameter of the suture edge (22) is the outer diameter of the suture ring (2); The end of the suture edge (22) away from the ring body (21) is used to connect with tissue near the mitral valve, and the suture edge (22) and the leaflet (5) are located on the same side of the ring body (21); the distance from the end of the suture edge (22) away from the ring body (21) to the ring body (21) is greater than the maximum distance from the leaflet (5) to the ring body (21), and is also greater than the minimum distance from the valve frame (4) to the ring body (21).

2. A valve according to claim 1, characterized in that: The suture edge (22) is a circular ring.

3. A valve according to claim 1, characterized in that: A connecting flange (23) is arranged on the outer side of one end of the suture edge (22) away from the ring body (21).

4. A valve according to claim 1, characterized in that: The suture edge (22) and the ring body (21) are connected by fibers made of polyethylene terephthalate.

5. A valve according to any one of claims 1 to 4, characterized in that: The valve leaflet (5) is an artificial biological valve.

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