Sinus tube and artificial heart valved sinus tube

Abstract

The invention provides a sinus tube and an artificial heart valved sinus tube. The sinus tube is provided with a proximal edge and a telecentric edge which are oppositely arranged in the length direction of the sinus tube. The sinus tube comprises a main tube body, the main tube body comprises a first opening edge, a second opening edge and three sinus bodies, the first opening edge and the second opening edge are oppositely arranged in the length direction of the main tube body, the first opening edge is close to the proximal edge, the second opening edge is close to the telecentric edge, and the three sinus bodies are all located between the first opening edge and the second opening edge and are rotationally symmetrical about the center axis of the sinus tube. Each sinus body comprises a valve leaflet attachment edge and two valve leaflet junction attachment edges, the valve leaflet attachment edges are close to the first mouth edge, and the two valve leaflet junction attachment edges are connected to the two opposite ends of the valve leaflet attachment edges in the circumferential direction of the main pipe body and extend in the direction from the first mouth edge to the second mouth edge; and one valve leaflet junction attachment edges of two adjacent sinus bodies coincide with each other.

Description

Technical Field

[0001] The present application relates to the technical field of artificial heart valves, and particularly to a sinus tube and an artificial heart valved sinus tube. Background Art

[0002] For patients with severe valvular heart disease, replacing the artificial heart valve is one of the most effective treatment methods. Currently, the artificial valves used clinically can be classified into mechanical valves (made of pyrolytic carbon (valve leaf) and alloy (valve annulus)) and biological valves (made of biological tissues from pigs, cows, etc.) according to the valve materials. The designed service life of mechanical valves is longer (more than 50 years), but due to the need to take anticoagulant drugs for life, adverse events such as bleeding or thromboembolism are likely to occur. The service life of biological valves is short, with an average life of 5 to 15 years, and they are prone to degenerative changes and eventually lose function due to calcification. Therefore, an artificial heart valved sinus tube with a long service life and reliable performance is needed. Summary of the Invention

[0003] The present application provides a sinus tube and an artificial heart valved sinus tube to solve the problems of bleeding or thromboembolism in the existing artificial heart valved sinus tube. The artificial heart valved sinus tube has a long service life and reliable performance.

[0004] The present application provides a sinus tube for use in an artificial heart valved sinus tube. The sinus tube has a proximal edge and a distal edge. Along the length direction of the sinus tube, the proximal edge and the distal edge are arranged in opposite directions. The sinus tube includes a main body, and the main body includes a first orifice edge, a second orifice edge, and three sinus bodies. Along the length direction of the main body, the first orifice edge and the second orifice edge are arranged in opposite directions. The first orifice edge is close to the proximal edge, and the second orifice edge is close to the distal edge. The three sinus bodies are all located between the first orifice edge and the second orifice edge, and are rotationally symmetric about the central axis of the sinus tube and all protrude in the direction away from the central axis of the sinus tube. Each sinus body includes a leaflet attachment edge and two leaflet junction attachment edges. The leaflet attachment edge is close to the first orifice edge. Along the circumferential direction of the main body, the two leaflet junction attachment edges are respectively connected to the opposite ends of the leaflet attachment edge, extend in the direction from the first orifice edge to the second orifice edge, and are connected to the second orifice edge. One of the leaflet junction attachment edges of two adjacent sinus bodies coincides.

[0005] Wherein, each sinus body is mirror-symmetric about the central plane of the sinus body. In each sinus body, the leaflet attachment edge is mirror-symmetric about the central plane of the sinus body, and the two leaflet junction attachment edges are mirror-symmetric about the central plane of the sinus body;

[0006] Wherein, the intersection line of the central planes of the three sinus bodies coincides with the central axis of the sinus tube.

[0007] Among them, the radius of the proximal edge is R, the radius of the distal edge is r, r=R*(0.8~1.1), the height of the sinus tube is Hh, Hh=R*(1.7~3), the height of each sinus body is hs, hs=R*(1.2~2.1), and the radius of each sinus body is ds, ds=R*(1.1~2).

[0008] Wherein, the sinus tube further comprises a ventricular-aortic transition section, the ventricular-aortic transition section is connected to the first opening edge, and the end of the ventricular-aortic transition section away from the first opening edge is the proximal edge.

[0009] Wherein, the sinus tube further comprises a sinus tube junction section, the sinus tube junction section is connected to the second opening edge, and the end of the sinus tube junction section away from the second opening edge is the distal edge.

[0010] Wherein, the sum of the heights of the sinus body and the junction section of the sinus tube is H, and H=R*(1.5-2.4).

[0011] Wherein, the main body, the ventricle-aorta transition section and the sinotubular junction section are integrally formed.

[0012] Wherein, the cross section of the sinus body is a parabola or a Bezier curve.

[0013] Wherein, the rotational symmetry angle of the three sinus bodies about the central axis of the sinus tube is 120 degrees.

[0014] The present application also provides an artificial heart with a valved sinus tube, comprising a valve and any of the above-mentioned sinus tubes, wherein the valve comprises three leaflets, and the three leaflets are all installed in the main body and are rotationally symmetrical about the central axis of the sinus tube. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the technical solution of the embodiments of the present application, the drawings required for use in the embodiments of the present application will be described below.

[0016] Figure 1 This is a schematic structural diagram of a first artificial heart with a valved sinus tube provided in an embodiment of the present application;

[0017] Figure 2 yes Figure 1 The schematic diagram of the structure of the artificial heart with valve sinus tube at another angle is shown;

[0018] Figure 3 yes Figure 1 The schematic diagram of the structure of the sinus tube in the artificial heart with valve;

[0019] Figure 4 yes Figure 3Schematic diagram of the structure of the sinus tube shown from another angle;

[0020] Figure 5 is Figure 4 Schematic diagram of the cross-sectional structure of the sinus tube shown after being cut along the I-I position;

[0021] Figure 6 is Figure 1 Schematic diagram of the leaflets of the valve in the artificial heart valved sinus tube shown;

[0022] Figure 7 It is a schematic diagram of the structure of the second artificial heart valved sinus tube provided by the embodiment of the present application. Detailed implementation manners

[0023] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application.

[0024] Please refer to Figure 1 and Figure 2 , Figure 1 is a schematic diagram of the structure of the first artificial heart valved sinus tube 500 provided by the embodiment of the present application, Figure 2 is Figure 1 Schematic diagram of the structure of the artificial heart valved sinus tube 500 shown from another angle.

[0025] The artificial heart valved sinus tube 500 has a central axis O, and the artificial heart valved sinus tube 500 is rotationally symmetric about the central axis O, and the rotational symmetry angle is 120 degrees. Among them, the artificial heart valved sinus tube 500 is made of a polymer material. Exemplarily, the artificial heart valved sinus tube 500 is made of a flexible material such as a high-strength polymer material or fiber.

[0026] The artificial heart valved sinus tube 500 includes a sinus tube 200 and a valve 100. The valve 100 is installed inside the sinus tube 200 and is connected to the inner wall surface of the sinus tube 200. Exemplarily, the valve 100 can be connected to the inner wall surface of the sinus tube 200 by means of suture, ultrasonic welding, adhesion or fitting. The sinus tube 200 includes a proximal edge 201 and a distal edge 202. Along the height direction of the sinus tube 200, the proximal edge 201 and the distal edge 202 are arranged in opposite directions.

[0027] It should be noted that in the human body, the aortic valve is located between the left ventricle and the ascending aorta, and opens as the left ventricle contracts. The normal aortic valve includes three semilunar leaflets, and the blood of the heart is pumped into the ascending aorta through the aortic valve, and is supplied to the whole body through the ascending aorta. When the artificial heart valved sinus tube 500 is used in the human body, the proximal edge 201 is close to the heart of the human body, and the distal edge 202 is far away from the heart of the human body. The blood of the heart can enter the interior of the sinus tube 200 from the proximal edge 201, the blood can impact the valve 100 to open the valve 100, and the blood can pass through the valve 100 and output from the artificial heart valved sinus tube 500 from the distal edge 202 to be pumped into the ascending aorta, thereby supplying the whole body. At this time, there will be a central blood flow from the proximal side 201 to the distal side 202 and a reverse blood flow from the distal side 202 to the proximal side 201 inside the sinus tube 200. The central blood flow will push the valve 100 to open, and the reverse blood will flow along the sinus wall of the sinus tube 200 to the proximal side 201 to push the valve 100 to close. When the pressure of the central blood flow is higher than the pressure of the reverse blood flow, the valve 100 opens, and when the pressure of the central blood flow is lower than the pressure of the reverse blood flow, the valve 100 closes. The artificial heart valved sinus tube 500 uses the pressure difference between the central blood flow and the reverse blood flow to achieve normal operation.

[0028] It can be understood that since the pressure difference between the central blood flow and the reverse blood flow is smaller, the impact force on the valve 100 is smaller, which reduces the impact damage to the valve 100 caused by the pressure difference between the central blood flow and the reverse blood flow, helps to extend the service life of the valve 100, and thereby improves the service life of the artificial heart with valve sinus tube 500.

[0029] See also Figures 3 to 5 , Figure 3 yes Figure 1 The structure diagram of the sinus tube 200 in the artificial heart with a valve sinus tube 500 is shown. Figure 4 yes Figure 3 The schematic diagram of the structure of the sinus tube 200 at another angle is shown. Figure 5 yes Figure 4 The cross-sectional structure diagram of the sinus tube 200 after being cut along II is shown.

[0030] In this embodiment, the sinus tube 200 is made of polyester material. The sinus tube 200 is rotationally symmetric about the central axis O. Among them, the rotational symmetry angle of the sinus tube 200 is 120 degrees. The sinus tube 200 includes a main body tube 21, a ventricle-aorta transition section 23, and a sinus tube junction section 25. Along the height direction of the sinus tube 200, the ventricle-aorta transition section 23 and the sinus tube junction section 25 are respectively connected to opposite ends of the main body tube 21. When the artificial heart valve sinus tube 500 is used in the human body, both the ventricle-aorta transition section 23 and the sinus tube junction section 25 are sutured to blood vessels. Among them, one end of the ventricle-aorta transition section 23 facing away from the main body tube 21 is the proximal edge 201, and one end of the sinus tube junction section 25 facing away from the main body tube 21 is the distal edge 202.

[0031] The main body tube 21 includes a first orifice edge 213 and a second orifice edge 215. Along the length direction of the main body tube 21, the first orifice edge 213 and the second orifice edge 215 are arranged in opposite directions. Among them, the first orifice edge 213 is connected to the ventricle-aorta transition section 23, and the second orifice edge 215 is connected to the sinus tube junction section 25. Exemplarily, the main body tube 21 can be connected to the ventricle-aorta transition section 23 and the sinus tube junction section 25 by means such as suturing or ultrasonic welding. Alternatively, the main body tube 21, the ventricle-aorta transition section 23, and the sinus tube junction section 25 can be integrally formed.

[0032] In addition, the main body tube 21 includes three sinus bodies 22, and all three sinus bodies 22 are located between the first orifice edge 213 and the second orifice edge 215. Specifically, the three sinus bodies 22 are arranged around the central axis O and are rotationally symmetric about the central axis O, and the rotational symmetry angle is 120 degrees. Exemplarily, the three sinus bodies 22 are evenly distributed along the cross-section of the main body tube 21. That is, around the circumference of the main body tube 21, the three sinus bodies 22 are connected end to end in sequence.

[0033] Each sinus body 22 protrudes away from the central axis O towards the outside of the main body tube 21 and each has a central plane S 1 , and each sinus body 22 is 1 mirror symmetric about the central plane S. Among them, the intersection line of the central planes S 1 of the three sinus bodies 22 coincides with the central axis O. Specifically, each sinus body 22 is generally in the shape of a convex hull, and the cross-section is an arc (parabolic or Bezier curve). Each sinus body 22 is formed by the wall of the main body tube 21 protruding radially and away from the central axis O to form a convex hull shape protruding outside the main body tube 21. Among them, the inner surface and the outer surface of the sinus body 22 are both outwardly convex arc surfaces away from the central axis O.

[0034] In addition, each sinus body 22 includes a leaflet attachment edge 221 and two leaflet junction attachment edges 222. The leaflet attachment edge 221 is 1Mirror symmetry. The attachment edge 221 of the valve leaflet is close to the proximal edge 201 and protrudes towards the proximal edge 201. The attachment edges 222 of the two valve leaflet junctions both extend from the proximal edge 201 towards the distal edge 202, respectively connect the opposite ends of the attachment edge 221 of the valve leaflet, and are both connected to the second orifice edge 215. The two attachment edges 222 of the valve leaflet junctions are mirror symmetric about the central plane S 1 Mirror symmetry. Among them, in two adjacent sinus bodies 22, one attachment edge 222 of the valve leaflet junction of one sinus body 22 coincides with one attachment edge 222 of the valve leaflet junction of the other sinus body 22.

[0035] In this embodiment, the radius of the proximal edge 201 is R, the radius of the distal edge 202 is r, the height of the sinus tube 200 is Hh, the height of each sinus body 22 is hs, the radius of each sinus body 22 is ds, and the total height of the junction segment 25 between the sinus body 22 and the sinus tube is H. It should be noted that the radius R of the proximal edge 201 is approximately equal to the radius of the human body's own blood vessel. Therefore, based on the radius R of the proximal edge 201, the various parameters of the artificial heart valved sinus tube 500 are designed accordingly. Among them, r = R*(0.8 - 1.1), Hh = R*(1.7 - 3), hs = R*(1.2 - 2.1), ds = R*(1.1 - 2), H = R*(1.5 - 2.4).

[0036] Please refer to Figure 2 and Figure 6 , Figure 6 is Figure 1 the schematic structural diagram of the valve leaflet 10 of the valve 100 in the artificial heart valved sinus tube 500 shown.

[0037] The valve 100 is rotationally symmetric about the central axis O, and the rotational symmetry angle is 120 degrees. The valve 100 includes three valve leaflets 10, and the three valve leaflets 10 are relatively independent. The three valve leaflets 10 are rotationally symmetric about the central axis O, and the rotational symmetry angle is 120 degrees. In this embodiment, the valve leaflet 10 is made of polyurethane material. Each valve leaflet 10 is in a thin sheet shape. Each valve leaflet 10 has a symmetry plane (not shown in the figure), and each valve leaflet 10 is mirror symmetric about the symmetry plane of the valve leaflet 10. Among them, each valve leaflet 10 includes a ventricular surface 101 and an aortic surface 102, and along the thickness direction of the valve leaflet 10, the ventricular surface 101 and the aortic surface 102 are arranged in opposite directions.

[0038] The valve 100 is installed inside the main body tube 21 and is connected to the inner wall surface of the main body tube 21. In this embodiment, the three valve leaflets 10 are all connected to the inner wall surface of the main body tube 21 and respectively correspond to the three sinus bodies 22. Among them, the symmetry plane of each valve leaflet 10 coincides with the central plane S of one sinus body 22 1Coplanar. The ventricular surface 101 of each leaflet 10 faces the proximal edge 201 of the sinus tube 200, and the aortic surface 102 of each leaflet 10 faces the distal edge 202 of the sinus tube 200, and is spaced and oppositely arranged with the inner wall surface of the sinus tube 200.

[0039] When the artificial heart valve sinus tube 500 is used in the human body, the blood of the heart intermittently enters the interior of the artificial heart valve sinus tube 500 from the proximal edge 201. The blood is in a pulsed state and can impact the valve 100. The blood acts on the ventricular surface 101 of the three leaflets 10, causing the three leaflets 10 to deform and move away from each other. The three leaflets 10 enclose to form a gap, and the valve 100 opens. The blood can pass through the gap of the valve 100 and be output from the distal edge 202 of the artificial heart valve sinus tube 500. When the blood of the heart flows forward and impacts the upper part of the sinus body, the blood inside the artificial heart valve sinus tube 500 will produce a reverse flow. The reverse flow of blood will flow along the inner wall surface of the sinus body 22 through the aortic surface 102 of the leaflet 10 to the proximal edge 201. The reverse flow of blood pushes the leaflet 10 to recover its deformation, and the valve 100 closes, preventing the reverse flow of blood from flowing back into the heart from the proximal edge 201 of the artificial heart valve sinus tube 500. It should be noted that when the blood flow ejected from the ventricle to the aorta acts on the ventricle of the leaflet 10, the thrust formed by the blood flowing back in the sinus body acts on the aortic surface 102 of the leaflet 10, and the pressure difference between the two determines the opening and closing of the leaflet 10.

[0040] The leaflet 10 adopted by the artificial heart valve sinus tube 500 in the embodiment of the present application can quickly close after the blood passes through, preventing blood backflow, and thus preventing heart failure caused by increased ventricular preload.

[0041] Please refer to Figure 7 , Figure 7 which is a schematic structural diagram of the second artificial heart valve sinus tube 500 provided by the embodiment of the present application.

[0042] The difference between the artificial heart valve sinus tube 500 shown in this embodiment and the artificial heart valve sinus tube 500 shown in the above first embodiment is that the sinus tube 200 includes a main tube 21 and a ventricle-aorta transition section 23. The structure of the main tube 21, the structure of the ventricle-aorta transition section 23, and the cooperation relationship between the main tube 21 and the ventricle-aorta transition section 23 can all refer to the relevant descriptions of the above first artificial heart valve sinus tube 500, and will not be repeated here. Among them, one end of the main tube 21 away from the ventricle-aorta transition section 23 is the distal edge 202.

[0043] Among them, the valve is an independent integrally formed structure, and the sinus tube 200 is an independent integrally formed mechanism. The integrally formed method includes weaving or injection molding. After the valve is installed in the sinus tube 200, the aortic surface faces the sinus body 22 and the centrifugal edge 202, and the aortic surface smoothly transitions with the inner wall surface of the sinus body 22. The valve 100 and the sinus tube 200 of this embodiment can be separately and independently formed and then assembled, which can improve the assembly accuracy.

[0044] Among them, the connection methods between the above two independent objects (such as valve leaflets, valves, sinus tube 200) include suture, ultrasonic welding, adhesion, and pressing, etc., and will not be introduced one by one.

[0045] The above description is only the specific implementation manner of the present application, but the protection scope of the present application is not limited thereto. Any person skilled in the art within the technical scope disclosed in the present application can easily think of changes or substitutions, which should all be covered within the protection scope of the present application; without conflict, the embodiments of the present application and the features in the embodiments can be combined with each other. Therefore, the protection scope of the present application shall be subject to the protection scope of the claims.

Claims

1. A sinus tube for use in an artificial heart with a valved sinus tube, characterized in that, the sinus tube has a proximal edge and a distal edge, along the length direction of the sinus tube, the proximal edge and the distal edge are arranged in opposite directions, the sinus tube includes a main body, the main body includes a first orifice edge, a second orifice edge and three sinus bodies, along the length direction of the main body, the first orifice edge and the second orifice edge are arranged in opposite directions, the first orifice edge is close to the proximal edge, the second orifice edge is close to the distal edge, all three sinus bodies are located between the first orifice edge and the second orifice edge, and are rotationally symmetric about the central axis of the sinus tube, and all protrude in a direction away from the central axis of the sinus tube, each sinus body includes a leaflet attachment edge and two leaflet junction attachment edges, the leaflet attachment edge is close to the first orifice edge, along the circumference of the main body, the two leaflet junction attachment edges are respectively connected to opposite ends of the leaflet attachment edge, and extend in the direction from the first orifice edge to the second orifice edge and are connected to the second orifice edge, and one of the leaflet junction attachment edges of two adjacent sinus bodies coincides.

2. The sinus tube according to claim 1, characterized in that, each sinus body is mirror-symmetric about the central plane of the sinus body, in each sinus body, the leaflet attachment edge is mirror-symmetric about the central plane of the sinus body, and the two leaflet junction attachment edges are mirror-symmetric about the central plane of the sinus body; wherein, the intersection line of the central planes of the three sinus bodies coincides with the central axis of the sinus tube.

3. The sinus tube according to claim 1 or 2, characterized in that, the radius of the proximal edge is R, the radius of the distal edge is r, r = R*(0.8 - 1.1), the height of the sinus tube is Hh, Hh = R*(1.7 - 3), the height of each sinus body is hs, hs = R*(1.2 - 2.1), and the radius of each sinus body is ds, ds = R*(1.1 - 2).

4. The sinus tube according to claim 1, characterized in that, the sinus tube further includes a ventricle-aorta transition section, the ventricle-aorta transition section is connected to the first orifice edge, and the end of the ventricle-aorta transition section facing away from the first orifice edge is the proximal edge.

5. The sinus tube according to claim 4, characterized in that, the sinus tube further includes a sinus tube junction section, the sinus tube junction section is connected to the second orifice edge, and the end of the sinus tube junction section facing away from the second orifice edge is the distal edge.

6. The sinus tube according to claim 5, characterized in that, the total height of the sinus body and the sinus tube junction section is H, H = R*(1.5 - 2.4).

7. The sinus tube according to claim 4 or 5, characterized in that, the main body, the ventricle-aorta transition section and the sinus tube junction section are integrally formed.

8. The sinus tube according to claim 1, characterized in that, the cross-section of the sinus body is a parabola or a Bessel curve.

9. The sinus tube according to claim 1, characterized in that, the rotational symmetry angle of the three sinus bodies about the central axis of the sinus tube is 120 degrees.

10. An artificial heart with a valved sinus tube, characterized in that, Comprising a valve and a sinus tube as described in any one of claims 1 to 9, the valve includes three valve leaflets, and all three valve leaflets are installed within the main tube body and are rotationally symmetric about the central axis of the sinus tube.

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