A spin-type artificial mechanical heart valve

Abstract

The application provides a rotating type artificial mechanical heart valve, and belongs to the technical field of heart valves, and comprises: a valve ring; a valve leaflet group, which is rotationally arranged in the valve ring; when the valve leaflet group is in an open state, a spiral channel is formed in the valve ring; and when the valve leaflet group is in a closed state, the valve leaflet group limits blood flow through the valve ring; the rotating type artificial mechanical heart valve of the application forms a spiral channel with the same rotation direction as the blood rotation flow state when the valve leaflet group is in the open state; the spiral channel is arranged to effectively rotate the blood flow, generate corresponding spiral flow state, and the rotation of the outlet blood flow is beneficial to the full flow and development of the blood flow in the aorta, reduces the turbulence, stagnation area and damage to the normal rotation flow state in the aorta, and the heart valve provided by the application has excellent hemodynamic characteristics and can effectively inhibit the aortic dilation complication caused by aortic valve replacement.

Description

Technical Field

[0001] This invention relates to the field of heart valve technology, and specifically to a rotating artificial mechanical heart valve. Background Technology

[0002] The heart is a slightly flattened cone-shaped body composed of atria and ventricles. The atrial septum and ventricular septum separate the atria and ventricles into the left atrium and left ventricle, and the right atrium and right ventricle, respectively. The atrioventricular valve located between the left atrium and left ventricle is called the mitral valve; the valve between the right atrium and right ventricle is the tricuspid valve; the valve between the left ventricle and aorta is the aortic valve; and the valve between the right ventricle and pulmonary artery is the pulmonary valve. The main function of the heart valves is to ensure unidirectional blood flow during heart contraction and relaxation, propelling blood through the body.

[0003] Patients with aortic stenosis or insufficiency due to rheumatic heart disease, valvular calcification in the elderly, or congenital valvular malformations often require aortic valve replacement surgery. Artificial valves can be divided into mechanical valves and bioprosthetic valves based on their materials. Although the use of bioprosthetic valves has become more common in recent years, considering the durability of biological tissues, the international recommendation is still for mechanical valves for patients under 50 years of age. Furthermore, due to the low prevalence of bioprosthetic valves in China and the relatively lagging development of related medical devices, the current usage rate of mechanical valves in China is approximately 80%. Because bileaflet valves have superior hemodynamic performance, they are the mainstream type of mechanical valve.

[0004] Similar to bicuspid aortic valve malformation, aortic dilatation and aortic aneurysm are among the medium- to long-term complications of aortic valve replacement surgery. Compared to a normal aortic valve, the implantation of a mechanical valve alters the jet flow pattern of blood entering the aorta, which may disrupt the normal swirling flow pattern of the aorta, change the erosion pattern of the vessel wall, cause abnormal local shear forces, affect the normal physiological function of the aorta, and lead to aortic dilatation. Summary of the Invention

[0005] Therefore, the technical problem to be solved by the present invention is to overcome the defects of existing mechanical valve implantation, which changes the jet state of blood entering the aorta, thereby potentially disrupting the normal swirling flow state of the aorta, changing the scouring pattern of the vessel wall, causing abnormal local shear force, affecting the normal physiological function of the aorta, and causing aortic dilation. Thus, the present invention provides a swirling artificial mechanical heart valve.

[0006] To address the aforementioned technical problems, the present invention provides a rotary artificial mechanical heart valve, comprising:

[0007] Lobe ring;

[0008] The leaflet assembly is rotatably disposed within the valve annulus. When the leaflet assembly is in the open state, a spiral channel is formed within the valve annulus. When the leaflet assembly is in the closed state, the leaflet assembly restricts blood flow through the valve annulus.

[0009] Optionally, the leaflet group includes:

[0010] The first leaflet is hinged to the inner wall of the valve ring;

[0011] The second leaflet is hinged to the inner wall of the valve ring, and the second leaflet and the first leaflet are arranged opposite to each other; when the first leaflet and the second leaflet are in the open state, they form the spiral channel in the valve ring.

[0012] Optionally, when the first and second leaflets are in the open state, a first channel is formed between the first leaflet and the inner wall of the valve ring, a second channel is formed between the first and second leaflets, and a third channel is formed between the second leaflet and the inner wall of the valve ring. The first, second, and third channels are all spiral channels.

[0013] Optionally, both the first and second leaflets include:

[0014] An inlet section is located on the inlet side of the valve annulus;

[0015] The flow guide is smoothly connected to the inlet section and is located on the outlet side of the valve ring. The flow guide has a curved structure and is used to form the spiral channel.

[0016] Optionally, the inlet section has a planar structure.

[0017] Optionally, the first and second leaflets have the same structure, and the second leaflet is installed on the opposite side of the first leaflet after being rotated 180° around the central axis of the valve ring.

[0018] Optionally, mounting surfaces are formed on both sides of the first and second leaflets, and a valve column is provided on the mounting surface. The inner wall of the valve annulus has a limiting pivot hole for inserting the valve column.

[0019] Optionally, the mounting surface is a plane, the inner wall of the valve ring has a mating plane that mates with the mounting surface, and the limiting pivot hole is disposed on the mating plane.

[0020] Optionally, the valve column is a flat structure, the limiting pivot hole is a groove-shaped structure with an aspect ratio greater than one, and the two ends of the limiting pivot hole in the length direction have space for the valve column to swing; the valve column has a first limit position in the limiting pivot hole to swing to one side to open the first and second valve leaves, and a second limit position to swing to the other side to close the first and second valve leaves.

[0021] Optionally, the valve annulus and leaflet assembly are made of pyrolytic carbon material, and the valve annulus is covered with a suture ring.

[0022] The technical solution of this invention has the following advantages:

[0023] 1. The swirl-type artificial mechanical heart valve provided by this invention, when the leaflet assembly is in the open state, forms a spiral channel within the valve annulus with the same swirling direction as the blood circulates. The spiral channel allows the blood to effectively swirl as it flows through, generating a corresponding spiral flow pattern. The swirl of the outgoing blood flow is beneficial for the full flow and development of blood in the aorta, reducing turbulence, stagnation zones, and disruption of the normal swirling flow pattern within the aorta. The heart valve provided by this invention has excellent hemodynamic characteristics and can effectively inhibit aortic dilation complications caused by aortic valve replacement surgery.

[0024] 2. The first and second leaflets provided by the present invention have a better hemodynamic performance due to the arrangement of the two sets of leaflets. After the first and second leaflets are opened, the formation of the spiral channel ensures the swirling of blood flow and reduces disruption of the normal swirling flow state.

[0025] 3. The first and second leaflets provided by the present invention, after opening, form a first channel, a second channel and a third channel, all of which are spiral in shape. The outlet ends of the first channel, the second channel and the third channel are spiral channels with the same direction of rotation as the blood swirling flow. The arrangement of the three sets of channels allows the blood to swirl in each channel when it passes through, resulting in better effect.

[0026] 4. The first and second leaflets provided by the present invention both include an inlet portion and a guide portion that are smoothly connected. When the first and second leaflets are fully open, the inlet portion with a planar structure is more conducive to the stable inflow of blood into the blood flow channel, and the guide portion with a curved structure can better form a spiral channel, which is conducive to the swirling of blood flow. The smooth transition between the inlet portion and the guide portion further stabilizes the swirling of blood flow, and the combination with the large opening angle can effectively reduce flow separation.

[0027] 5. The first and second leaflets provided by the present invention have the same structure. The second leaflet is installed on the opposite side of the first leaflet after being rotated 180° around the central axis of the valve ring. This makes the starting environment space of the first channel and the third channel the same, avoiding excessive difference that may disturb blood flow.

[0028] 6. The valve column and limiting pivot hole provided by the present invention allow the first and second leaflets to rotate around the valve column to form a blood flow channel. The mounting surfaces of the first and second leaflets, and the mating planes on the inner wall of the valve annulus, ensure that the contact surface between the leaflets and the valve annulus is planar during leaflet rotation. This planar design ensures that the first and second leaflets can rotate at a large angle without interference. The large opening angle helps to increase the blood flow rate in each channel, especially the second channel. While increasing the effective opening area, it makes the blood flow more approximately central, resulting in smoother blood flow. It effectively reduces flow separation caused by leaflet tilt angle, providing a better environment for blood flow swirl. The increased effective opening area helps to reduce peak flow velocity, making blood flow smoother and achieving better hemodynamic characteristics.

[0029] 7. The valve column rotates in the limiting pivot hole. The first and second limit positions in the limiting pivot hole restrict the degree of rotation of the first and second valve leaves. No additional limiting components are required. The structure is simple and easy to manufacture. Attached Figure Description

[0030] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0031] Figure 1 A perspective view of a specific embodiment of the rotary artificial mechanical heart valve provided in the embodiments of the present invention;

[0032] Figure 2 for Figure 1 A top-view structural diagram;

[0033] Figure 3 for Figure 1 A three-dimensional structural diagram of the second lobe in the middle;

[0034] Figure 4 for Figure 1 Schematic diagram of the middle valve annulus;

[0035] Figure 5 for Figure 1 A schematic diagram of the frontal structure of the second lobe of the middle lobe;

[0036] Figure 6 for Figure 4 Front sectional view;

[0037] Figure 7 for Figure 2 Front sectional view;

[0038] Figure 8 for Figure 7 A schematic diagram showing the first and second leaflets in their second extreme positions.

[0039] Figure 9 This is a three-dimensional structural schematic diagram of another specific embodiment of the rotating artificial mechanical heart valve provided in the embodiments of the present invention.

[0040] Explanation of reference numerals in the attached figures:

[0041] 1. Valve annulus; 2. Valve leaflet assembly; 4. Suture ring; 11. Limiting pivot hole; 12. Mating plane; 21. First leaflet; 22. Second leaflet; 23. Valve column; 31. First channel; 32. Second channel; 33. Third channel; 111. First extreme position; 112. Second extreme position; 211. Inlet section; 212. Guide section; 213. Mounting surface. Detailed Implementation

[0042] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0043] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0044] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0045] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0046] The rotating artificial mechanical heart valve provided in this embodiment is used for aortic valve replacement.

[0047] like Figure 1 As shown, this is a specific implementation of the rotating artificial mechanical heart valve provided in this embodiment, including a valve annulus 1 and a leaflet group 2 rotatably disposed within the valve annulus 1. When the leaflet group 2 is in the open state, a spiral channel is formed within the valve annulus 1. When the leaflet group 2 is in the closed state, the leaflet group 2 restricts blood flow through the valve annulus 1.

[0048] The annulus 1 is a channel for blood flow. When the leaflet group 2 is in the open state, the channel for blood flow in the annulus 1 is in a flowing state, and this channel is a spiral channel. The spiral channel design allows the blood to effectively swirl as it flows through, generating a corresponding spiral flow pattern. The swirl of the outgoing blood flow is conducive to the full flow and development of blood in the aorta, reducing turbulence, stagnation areas, and disruption of the normal swirling flow pattern of the aorta. The heart valve provided in this embodiment has excellent hemodynamic characteristics and can effectively inhibit aortic dilation complications caused by aortic valve replacement surgery.

[0049] like Figure 1 As shown, in the rotating artificial mechanical heart valve provided in this embodiment, the leaflet assembly 2 includes: a first leaflet 21 and a second leaflet 22 respectively hinged to the inner wall of the valve annulus 1. The first leaflet 21 and the second leaflet 22 are arranged opposite to each other, and the spiral channel is opened or closed by rotating on the inner wall of the valve annulus 1. In addition, as an alternative implementation, the leaflet assembly 2 can also be other structures, such as a combination of three leaflets.

[0050] like Figure 2 As shown, in the spiral-type artificial mechanical heart valve provided in this embodiment, when the first leaflet 21 and the second leaflet 22 are in the open state, a first channel 31 is formed between the first leaflet 21 and the inner wall of the valve annulus 1, a second channel 32 is formed between the first leaflet 21 and the second leaflet 22, and a third channel 33 is formed between the second leaflet 22 and the inner wall of the valve annulus 1. The first channel 31, the second channel 32, and the third channel 33 are all spiral channels. The arrangement of the first channel 31 and the third channel 33 allows the blood flow on both sides to quickly spiral, while the arrangement of the second channel 32 allows the blood flow in the middle to spiral out after flowing out from this channel. The arrangement of the three channels ensures that the blood flow in each channel spirals simultaneously, resulting in smoother blood flow without excessive disturbance. Furthermore, as an alternative implementation, the number of channels can vary with the number of leaflets.

[0051] like Figure 2 As shown, in the rotating artificial mechanical heart valve provided in this embodiment, the first leaflet 21 and the second leaflet 22 have the same structure. The second leaflet 22 is installed on the opposite side of the first leaflet 21 after rotating 180° around the central axis of the valve annulus 1. This ensures that the rotating environment space of the channels on both sides of the first leaflet 21 and the second leaflet 22 is the same, avoiding excessive differences that could disturb blood flow. Furthermore, as an alternative implementation, the structural size of the first leaflet 21 and the second leaflet 22 can be adjusted according to their relative positions.

[0052] like Figure 3 As shown, in the swirl-type artificial mechanical heart valve provided in this embodiment, both the first leaflet 21 and the second leaflet 22 include an inlet portion 211 and a guide portion 212. The inlet portion 211 has a planar structure, and the guide portion 212 has a spiral curved surface structure. The inlet portion 211 is located on the inlet side of the valve annulus 1, and the guide portion 212 is located on the outlet side of the valve annulus 1. When blood enters the channel, it first passes through the inlet portion 211 and then through the curved guide portion 212. The guide portion 212 causes the blood flow to swirl. The planar structure of the inlet portion 211 is more conducive to the stable flow of blood into the blood flow channel. The smooth transition between the inlet portion 211 and the guide portion 212 ensures the stability of the blood flow swirl. In this embodiment, when the first leaflet 21 and the second leaflet 22 rotate from the closed state to the open state, the angle between the first leaflet 21 and the second leaflet 22 and the inlet side end face of the valve annulus 1 is the opening angle. When the first leaflet 21 and the second leaflet 22 rotate from the closed state to the maximum open state limit position, the opening angle at this time is the maximum opening angle, which is 85° to 90°. This large opening angle can effectively reduce blood flow separation. In addition, as an alternative embodiment, the guide portion 212 can also be other curved surface structures that form a spiral channel.

[0053] like Figure 3 and Figure 4As shown, in the rotating artificial mechanical heart valve provided in this embodiment, mounting surfaces 213 are formed on both sides of the first leaflet 21 and the second leaflet 22. The mounting surfaces 213 are planar structures, and valve columns 23 are provided on the mounting surfaces 213. The inner wall of the valve annulus 1 has a mating plane 12 that cooperates with the mounting surfaces 213. The mating plane 12 has a limiting pivot hole 11 for inserting the valve column 23. When the first leaflet 21 and the second leaflet 22 rotate, the mounting surfaces 213 rotate on the mating plane 12. The planar setting ensures that the first leaflet 21 and the second leaflet 22 can rotate to the maximum opening angle and do not interfere during the rotation. The large opening angle is conducive to increasing the blood flow in each channel, especially the second channel 32. While increasing the effective opening area, it makes the blood flow more approximately central, making the blood flow more stable, effectively reducing the flow separation caused by the leaflet tilt angle, providing a better environment for blood flow to rotate. The increased effective opening area is conducive to reducing the peak flow velocity, making the blood flow more gentle, and achieving better hemodynamic characteristics. Alternatively, as an alternative implementation, the mounting surface 213 can be other structures that allow the first leaflet 21 and the second leaflet 22 to rotate.

[0054] like Figure 5 As shown, in the rotating artificial mechanical heart valve provided in this embodiment, the top and bottom surfaces of the first leaflet 21 and the second leaflet 22 are both sloping surfaces. This sloping surface design ensures that when the first leaflet 21 and the second leaflet 22 are in the closed state, the contact points between the first leaflet 21 and the inner wall of the valve annulus 1, the contact points between the second leaflet 22 and the inner wall of the valve annulus 1, and the contact points between the first leaflet 21 and the second leaflet 22 are all in a close fit. This allows for perfect contact between the first leaflet 21, the second leaflet 22, and the valve annulus 1, effectively reducing regurgitation. Alternatively, as an alternative implementation, the top and bottom surfaces of the first leaflet 21 and the second leaflet 22 can also be other structures, such as curved surfaces.

[0055] like Figure 5 As shown, in the rotating artificial mechanical heart valve provided in this embodiment, the valve column 23 has a flat structure. The valve column 23 can be configured as a combination of a straight groove column, a half-cylinder, and two quarter-spheres. The thickness of the straight groove column is consistent with the diameter of the spheres and cylinders. The straight groove column smoothly transitions with the cylinders and spheres. This structure effectively disperses the load generated when the valve column 23 contacts and collides with the side of the limiting pivot hole 11, enhancing the mechanical strength of the valve column 23. The surface of the valve column 23 that contacts the bottom surface of the limiting pivot hole 11 is spherical, reducing the contact area between the valve column 23 and the bottom surface of the limiting pivot hole 11, thereby reducing friction and wear. Alternatively, as an alternative implementation, the valve column 23 can also be other structures, such as a semi-cylinder.

[0056] like Figure 6-8As shown, in the rotating artificial mechanical heart valve provided in this embodiment, the limiting pivot hole 11 is a groove-shaped structure with an aspect ratio greater than one. Both ends of the limiting pivot hole 11 in the length direction have space for the valve column 23 to swing. The valve column 23 has a first extreme position 111 within the limiting pivot hole 11, swinging to one side to open the first leaflet 21 and the second leaflet 22, and a second extreme position 112, swinging to the other side to close the first leaflet 21 and the second leaflet 22. The groove-shaped structure with an aspect ratio greater than one ensures the rotation space of the valve column 23 within the limiting pivot hole 11. The limiting pivot hole 11 can be a waist-shaped groove structure adapted to the valve column 23, or it can be a groove formed by two isosceles trapezoids arranged opposite each other to adapt to the valve column 23. The edges are all rounded transitions. The isosceles trapezoidal combined groove structure has a narrower retractable structure in the middle, which makes the valve column 23 more stable within it, avoiding large shaking of the valve column 23 during rotation and affecting blood flow. The groove-shaped structure is an open structure that allows blood to flush it out, preventing thrombus formation. The first limit position 111 and the second limit position 112 in the limiting pivot hole 11 restrict the degree of rotation of the first leaflet 21 and the second leaflet 22, eliminating the need for additional limiting components. The structure is simple and easy to manufacture.

[0057] In the rotating artificial mechanical heart valve provided in this embodiment, the valve annulus 1 and the leaflet assembly 2 are made of pyrolytic carbon material. Pyrolytic carbon material has good mechanical properties, which improves the service life of the mechanical heart valve. Figure 9 As shown, the valve annulus 1 is covered with a suture ring 4, and the heart valve provided in this embodiment is sutured to the aorta through the suture ring 4.

[0058] This embodiment can adapt to the blood flow swirl in the aorta by adjusting the curvature of the first leaflet 21 and the second leaflet 22, and can also achieve better hemodynamic characteristics by adjusting the position of the limiting pivot orifice 11 and the valve column 23.

[0059] Working process: Blood enters the first channel 31, the second channel 32 and the third channel 33 inside the valve annulus 1 from the inlet side. The blood first passes through the inlet section 211 in the channel, and then passes through the curved guide section 212 to start swirling, generating a corresponding spiral flow state. This reduces the disruption of the normal swirling flow state of blood in the aorta and has excellent hemodynamic characteristics, which can effectively inhibit the aortic dilation complications caused by aortic valve replacement surgery.

[0060] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A rotating artificial mechanical heart valve, characterized in that, include: Lobe ring (1); The leaflet group (2) is rotatably disposed within the valve annulus (1). When the leaflet group (2) is in the open state, a spiral channel is formed within the valve annulus (1). When the leaflet group (2) is in the closed state, the leaflet group (2) restricts blood flow through the valve annulus (1). The leaflet group (2) includes: The first leaflet (21) is hinged to the inner wall of the valve ring (1); The second leaflet (22) is hinged to the inner wall of the valve ring (1), and the second leaflet (22) and the first leaflet (21) are arranged opposite to each other; when the first leaflet (21) and the second leaflet (22) are in the open state, they form the spiral channel in the valve ring (1); When the first leaflet (21) and the second leaflet (22) are in the open state, a first channel (31) is formed between the first leaflet (21) and the inner wall of the petiole ring (1), a second channel (32) is formed between the first leaflet (21) and the second leaflet (22), and a third channel (33) is formed between the second leaflet (22) and the inner wall of the petiole ring (1). The first channel (31), the second channel (32) and the third channel (33) are all spiral channels. The first leaflet (21) and the second leaflet (22) both include: An inlet section (211) is provided on the inlet side of the valve ring (1); The guide section (212) is smoothly connected to the inlet section (211) and is located on the outlet side of the valve ring (1). The guide section (212) has a curved surface structure and is used to form the spiral channel.

2. The rotary artificial mechanical heart valve according to claim 1, characterized in that, The inlet section (211) has a planar structure.

3. The rotary artificial mechanical heart valve according to claim 2, characterized in that, The first leaflet (21) and the second leaflet (22) have the same structure. The second leaflet (22) is installed on the opposite side of the first leaflet (21) after being rotated 180° around the central axis of the leaflet ring (1).

4. The rotary artificial mechanical heart valve according to claim 3, characterized in that, The first leaflet (21) and the second leaflet (22) have mounting surfaces (213) on both sides respectively. A valve column (23) is provided on the mounting surface (213). The inner wall of the valve ring (1) has a limiting pivot hole (11) for inserting the valve column (23).

5. The rotary artificial mechanical heart valve according to claim 4, characterized in that, The mounting surface (213) is a plane, and the inner wall of the valve ring (1) has a mating plane (12) that mates with the mounting surface (213). The limiting pivot hole (11) is disposed on the mating plane (12).

6. The rotary artificial mechanical heart valve according to claim 5, characterized in that, The valve column (23) is a flat structure, and the limiting pivot hole (11) is a groove-shaped structure with an aspect ratio greater than one. The two ends of the limiting pivot hole (11) in the length direction have space for the valve column (23) to swing. The valve column (23) has a first limit position (111) in the limiting pivot hole (11) to swing to one side to open the first leaflet (21) and the second leaflet (22), and also has a second limit position (112) to swing to the other side to close the first leaflet (21) and the second leaflet (22).

7. The rotary artificial mechanical heart valve according to any one of claims 1-6, characterized in that, The valve ring (1) and the leaflet group (2) are made of pyrolytic carbon material, and the valve ring (1) is covered with a suture ring (4).

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