Pulsatile percutaneous ventricular assist device and two-way valve thereof

Abstract

A two-way valve and a pulsatile percutaneous ventricular assist device using same. The two-way valve comprises: a valve body (1) with an inner cavity (10) passing through, the inner cavity being provided with a proximal port (1a) and a distal port (1b), and the valve body (1) being provided with an open window (1c) in communication with the inner cavity (10) and the outside of the valve body (1); and a valve flap (2) arranged in the inner cavity (10) and rotationally connected to the valve body (1), the valve flap (2) comprising a first valve leaf (21), a second valve leaf (22), and a third valve leaf (23), which are connected at an obtuse angle, the first valve leaf (21) being arranged at the open window (1c), the second valve leaf (22) being arranged on one side close to the inner cavity (10) at one end of the first valve leaf (21) close to the proximal port (1a), and the third valve leaf (23) being arranged on one side close to the inner cavity at one end of the first valve leaf close to the distal port (1b). The valve flap (2) is impacted by blood flow axially flowing in the inner cavity (10) and is rotationally switched back and forth between an open position and a closed position. In the open position, the three valve leaves together partition the proximal port (1a) and the distal port (1b), and the open window (1c) is opened and in communication with the distal port (1b). In the closed position, the first valve leaf (21) closes the open window (1c), and the proximal port (1a) is in communication with the distal port (1b), thereby achieving better switching response and sealing effects.

Description

Pulsatile interventional ventricular assist device and its bidirectional valve Technical Field

[0001] The present invention relates to the technical field of ventricular assist devices, and in particular to a two-way valve and a pulsatile interventional ventricular assist device using the two-way valve. Background Art

[0002] Interventional ventricular assist devices (pVADs) offer advantages such as minimal trauma, few complications, and ease of use. By effectively supporting the circulatory system, they can correct acute hemodynamic disturbances, improve tissue perfusion, and buy patients valuable time for rescue. pVADs are intended for short- to medium-term use, primarily for intraoperative support of high-risk PCI patients and rehabilitation therapy for patients with cardiogenic shock.

[0003] An interventional ventricular assist device typically connects a ventricular assist pump to the left ventricle via an interventional catheter. A two-way valve is installed on the interventional catheter, positioned in the ascending aorta. An external diaphragm pump with a set pulse frequency and a catheter connected via a connector pumps out and reinjects blood. The two-way valve directs blood flow: during blood withdrawal, blood in the left ventricle flows through the interventional catheter and the two-way valve into the external diaphragm pump. During blood reinjection, pressurized blood in the diaphragm pump flows into the interventional catheter, where the two-way valve automatically reverses direction due to pressure, ejecting blood from the catheter into the aorta. This achieves left ventricular assistance.

[0004] Therefore, the performance of the bidirectional valve is crucial to the operation of the interventional ventricular assist device. Improving the bidirectional valve to enhance and optimize its switching response and sealing effect can enhance and optimize the working capacity and operation of the interventional ventricular assist device.

[0005] Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide a two-way valve that can be opened and closed stably and has better switching response and sealing effect.

[0007] In order to solve the above technical problems, the present invention adopts the following technical solutions:

[0008] The present invention provides a two-way valve, comprising: a valve body, the interior of which is axially penetrated to form an inner cavity with a proximal port and a distal port, a window being provided on the valve body between the proximal port and the distal port, the window connecting the inner cavity with the outside of the valve body; a valve flap, arranged in the inner cavity and rotatably connected to the valve body, the valve flap comprising a first valve leaf arranged at the window opening, a second valve leaf connected to an end of the first valve leaf close to the proximal port at an obtuse angle on a side of the first valve leaf close to the inner cavity, and a third valve leaf connected to an end of the first valve leaf close to the distal port at an obtuse angle on a side of the first valve leaf close to the inner cavity; the valve flap is impacted by the axially flowing blood flow in the inner cavity and rotates back and forth between an open position and a closed position; in the open position, the second valve leaf, the first valve leaf and the third valve leaf jointly separate the proximal port and the distal port, the window opening is opened and connected to the distal port; in the closed position, the first valve leaf closes the window opening, and the proximal port and the distal port are connected.

[0009] Preferably, the first valve leaf and the second valve leaf are both arc-shaped sheet-like structures. In the closed position, the first valve leaf is convex toward the outside of the window opening, and the second valve leaf is convex toward the proximal port, with a smooth transition between the first valve leaf and the second valve leaf; the third valve leaf is an arc-shaped sheet-like structure. In the closed position, the third valve leaf is convex toward the distal port, with a smooth transition between the first valve leaf and the third valve leaf; or, the third valve leaf is a slightly arched flat sheet-like structure. In the closed position, the third valve leaf is slightly convex toward the proximal port; or, the third valve leaf is a flat sheet-like structure.

[0010] Preferably, the edge of the first valve leaf and the edge of the third valve leaf are connected to form a first side edge away from the second valve leaf, and the second valve leaf has a second side edge away from the first valve leaf. In the open position, the first side edge is tangent to the inner cavity wall, and the second side edge contacts the inner cavity wall and closes the end of the window close to the proximal port.

[0011] Preferably, the window includes a first beveled window surface, a flat cut window surface and a second beveled window surface which are connected in sequence and formed by continuous cutting on the valve body. The first beveled window surface and the second beveled window surface form an angle or are parallel to each other. There are two flat cut window surfaces, and both flat cut window surfaces are parallel to the axis of the valve body and symmetrical about a center line of symmetry.

[0012] Preferably, a connecting part is provided at each end of the first valve leaf, and the connecting part is rotatably connected to the valve body through a pin. The axis of the pin is perpendicular to the axis of the valve body and the plane where the symmetrical center lines of the two flat-cut window surfaces are located. The axis of the pin intersects with the axis of the valve body, or the axis of the pin is offset to the side of the axis of the valve body away from the window.

[0013] Preferably, there is a gap between the connecting portion and the wall of the inner cavity.

[0014] Preferably, the valve body has a middle section, the window is provided in the middle section, the cross-sectional shape of the outer peripheral contour of the middle section is an arc shape with a maximum diameter distance of D, and the size of the gap is D / 50-D / 100.

[0015] Preferably, the valve body has a middle section, and the window is arranged in the middle section. The cross-sectional shape of the outer peripheral contour of the middle section is an arc shape and the maximum diameter distance is D. In the closed position, the maximum length of the valve disc as a whole extending along the axial direction of the valve body is 1.5D-2D, and the maximum height of the valve disc as a whole extending along the radial direction of the valve body is 0.5D-0.7D. The distance between the side tip of the end of the third valve leaf away from the first valve leaf and the axis of the pin shaft along the axial direction of the valve body is 1D-1.7D.

[0016] Preferably, the angle between the first oblique cut window surface and the vertical plane perpendicular to the axis of the valve body is 0-45°, and the angle between the second oblique cut window surface and the vertical plane perpendicular to the axis of the valve body is 0-80°; the valve body has a middle section, and the window is provided in the middle section. The cross-sectional shape of the outer peripheral contour of the middle section is an arc shape with a maximum diameter distance of D. The length of the flat cut window surface extending along the axial direction of the valve body is P, and the length P is 0.5D-1.5D. The maximum length of the window extending along the axial direction of the valve body is O, and the length O is 0.8D-2D. The ratio of the length P to the length O is 1 / 4-1.

[0017] Preferably, in the closed position, a side of the first valve leaf away from the second valve leaf abuts against the wall of the inner cavity.

[0018] Preferably, the included angle between the first valve leaf and the second valve leaf is 100°-160°.

[0019] Preferably, the included angle between the first valve leaf and the third valve leaf is 120°-175°.

[0020] Preferably, the valve body has a middle section, and the window is arranged in the middle section. The cross-sectional shape of the outer peripheral contour of the middle section is circular and has a diameter of D. The length of the first valve leaf is 0.5D-1.5D, the length of the second valve leaf is 0.1D-0.6D, and the length of the third valve leaf is 0.1D-0.8D. The ratio of the length of the second valve leaf to the length of the third valve leaf is 1 / 5-1 / 2.

[0021] Preferably, the valve flap rotates from the closed position to the open position through an angle of 25°-60°.

[0022] The present invention also provides a pulsatile interventional ventricular assist device, which uses the bidirectional valve described above.

[0023] Compared with the prior art, the present invention has significant improvements:

[0024] The two-way valve of the present invention drives the valve flap to rotate by the blood flow impacting the first and second valve leaves of the valve flap when the blood flow direction changes, so that the valve flap automatically rotates and switches between the closed position and the open position in accordance with the change in blood flow direction, thereby achieving timely and reliable switching response. In particular, by arranging a third valve leaf at one end of the first valve leaf near the distal end of the inner cavity of the valve body, the angle of attack of the first valve leaf to the blood flow is increased when blood flows from the distal end of the inner cavity to the proximal end, thereby increasing the force and torque applied to the valve flap under the action of blood flow, making the response speed of the valve flap rotating from the closed position to the open position faster; at the same time, the valve flap closes the window on the valve body in the closed position and separates the proximal end and the distal end of the inner cavity in the open position, and the blood flow impact causes the valve flap to remain in the closed position or the open position, thereby achieving a reliable and stable sealing effect. Therefore, the two-way valve of the present invention can achieve stable opening and closing, better switching response and sealing effect, and has better blood flow guiding ability. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] FIG1 is a schematic diagram of the three-dimensional structure of a valve body of a two-way valve according to a first embodiment of the present invention.

[0026] FIG2 is a schematic front view of the valve body of the two-way valve according to the first embodiment of the present invention.

[0027] FIG3 is a schematic diagram of the three-dimensional structure of the valve disc of the two-way valve according to the first embodiment of the present invention.

[0028] FIG4 is a schematic front view of the valve disc of the two-way valve according to the first embodiment of the present invention.

[0029] FIG5 is a schematic top view of the valve disc of the two-way valve according to the first embodiment of the present invention.

[0030] FIG6 is a cross-sectional schematic diagram of the valve disc of the two-way valve in the closed position according to the first embodiment of the present invention.

[0031] FIG7 is a perspective schematic diagram of the two-way valve according to the first embodiment of the present invention, with the valve flap in the open position.

[0032] FIG8 is a top view of the two-way valve according to the first embodiment of the present invention, with the valve flap in the open position.

[0033] FIG9 is a schematic cross-sectional view along the AA direction in FIG8 .

[0034] FIG10 is a left side schematic diagram of the two-way valve of the first embodiment of the present invention, when the valve disc is in the open position.

[0035] FIG11 is a three-dimensional schematic diagram of the two-way valve according to the first embodiment of the present invention, with the valve flap in the closed position.

[0036] FIG12 is a top view of the two-way valve according to the first embodiment of the present invention, with the valve disc in the closed position.

[0037] FIG13 is a schematic cross-sectional view along line BB in FIG12 .

[0038] FIG14 is a left side schematic diagram of the two-way valve of the first embodiment of the present invention, when the valve disc is in the closed position.

[0039] FIG15 is a schematic diagram of the two-way valve of the first embodiment of the present invention, in which the valve disc rotates and switches between the closed position and the open position.

[0040] FIG16 is a schematic diagram of the three-dimensional structure of the valve disc of the two-way valve according to the second embodiment of the present invention.

[0041] FIG17 is a schematic front view of the valve disc of the two-way valve according to the second embodiment of the present invention.

[0042] FIG18 is a schematic top view of the valve disc of the two-way valve according to the second embodiment of the present invention.

[0043] FIG19 is a cross-sectional schematic diagram of the valve flap of the two-way valve in the closed position according to the second embodiment of the present invention.

[0044] FIG20 is a cross-sectional view of a two-way valve according to a second embodiment of the present invention, with the valve flap in an open position.

[0045] FIG21 is a cross-sectional schematic diagram of the two-way valve of the second embodiment of the present invention, when the valve disc is in the closed position.

[0046] FIG22 is a schematic structural diagram of a pulsatile interventional ventricular assist device according to a third embodiment of the present invention.

[0047] : The reference numerals are described as follows: 1 valve body 10 inner cavity 1a proximal port 1b distal port 1c window 1c1 first oblique window surface 1c2 flat window surface 1c3 second oblique window surface 11 middle section 12 proximal section 13 distal section 2 valve disc 21 first valve leaf 2a first side edge 21b connecting portion 211 first arcuate convex surface 212 first arcuate concave surface 22 second valve leaf 2b second side edge 221 second arcuate convex surface 222 second arcuate concave surface 23 third valve leaf 231 first surface 232 second surface 3 pin 4 gap 100 ventricular catheter 200 two-way valve 300 peripheral catheter 400 pump 500 femoral artery 600 heart 700 aorta DETAILED DESCRIPTION

[0048] The following is a further detailed description of the specific embodiments of the present invention in conjunction with the accompanying drawings. These embodiments are only used to illustrate the present invention, and are not intended to limit the present invention.

[0049] In the description of the present invention, it should be noted that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "back," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer" and the like, indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely to facilitate and simplify the description of the present invention. They are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation, and therefore should not be construed as limiting the present invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0050] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediate medium; and internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0051] Furthermore, in the description of the present invention, unless otherwise specified, “plurality” means two or more.

[0052] Example 1

[0053] As shown in Figures 1 to 15 , a first embodiment of a two-way valve provided by the present invention is shown. The two-way valve of this embodiment 1 includes a valve body 1 and a valve flap 2 .

[0054] The valve body 1 has an axially continuous inner cavity 10, which includes a proximal port 1a and a distal port 1b that are axially opposed and connected to each other. A window 1c is provided between the proximal port 1a and the distal port 1b, connecting the inner cavity 10 of the valve body 1 with the exterior of the valve body 1.

[0055] The valve flap 2 is disposed within the inner cavity 10 of the valve body 1 and is rotatably connected to the valve body 1. The valve flap 2 includes a first valve leaf 21, a second valve leaf 22, and a third valve leaf 23. The second valve leaf 22, the first valve leaf 21, and the third valve leaf 23 are connected in sequence, with the first valve leaf 21 and the second valve leaf 22 connected at an obtuse angle, and the first valve leaf 21 and the third valve leaf 23 connected at an obtuse angle. The first valve leaf 21 is disposed at the window 1c of the inner cavity 10 of the valve body 1 and is used to close the window 1c. The second valve leaf 22 is disposed at the end of the first valve leaf 21 near the proximal end 1a of the inner cavity 10 of the valve body 1 and is located on the side of the first valve leaf 21 near the inner cavity 10 of the valve body 1. The third valve leaf 23 is disposed at the end of the first valve leaf 21 near the distal end 1b of the inner cavity 10 of the valve body 1 and is located on the side of the first valve leaf 21 near the inner cavity 10 of the valve body 1. The valve flap 2 is impacted by the blood flow axially flowing in the inner cavity 10 and rotates back and forth between the open position and the closed position.

[0056] Referring to Figures 7 to 10, in the open position, the second valve leaf 22 of the valve flap 2 is located at one end of the opening window 1c close to the proximal port 1a of the inner cavity 10 of the valve body 1, and the first valve leaf 21 and the third valve leaf 23 of the valve flap 2 are located in the inner cavity 10 of the valve body 1. The second valve leaf 22, the first valve leaf 21 and the third valve leaf 23 of the valve flap 2 jointly separate the proximal port 1a and the distal port 1b of the inner cavity 10, and the opening window 1c is opened and connected to the distal port 1b. At this time, the inner cavity 10 of the valve body 1 is not conductive, and the blood entering the valve body 1 from the distal port 1b can flow out from the opening window 1c. At this time, the two-way valve guides the blood flow from the distal port 1b of the inner cavity 10 to the opening window 1c. The impact of the blood flow on the third valve leaf 23 and the first valve leaf 21 of the valve flap 2 can keep the valve flap 2 in the open position. When the blood flow direction changes to flow from the proximal port 1a of the inner cavity 10 to the distal port 1b, the blood flow impacts the first valve leaf 21 and the third valve leaf 23 of the valve flap 2 in the opposite direction, giving the first valve leaf 21 and the third valve leaf 23 a force to rotate toward the outside of the inner cavity 10, causing the valve flap 2 to rotate toward the closed position. During the rotation process, the second valve leaf 22 rotates toward the inside of the inner cavity 10 and gradually intervenes in the blood flow, which can also play a flow-blocking role, and can further drive the valve flap 2 to rotate faster until it reaches the closed position.

[0057] Referring to Figures 11 to 14 , in the closed position, the first valve leaf 21 of the valve flap 2 is located at the window 1c, and the second and third valve leaves 22, 23 of the valve flap 2 are both located within the inner cavity 10 of the valve body 1. The first valve leaf 21 of the valve flap 2 closes the window 1c, connecting the proximal port 1a and the distal port 1b. This allows the inner cavity 10 of the valve body 1 to flow axially from the inner cavity 10 through the valve body 1. At this point, the two-way valve directs blood flow from the proximal port 1a to the distal port 1b of the inner cavity 10. The impact of the blood flow on the second and third valve leaves 22, 23 of the valve flap 2 maintains the valve flap 2 in the closed position. When the blood flow direction changes to flow from the distal port 1b of the inner cavity 10 to the proximal port 1a, the angle area between the side of the third valve leaf 23 facing the outside of the inner cavity 10 and the wall of the inner cavity 10 forms a flow blocking area, which constitutes the angle of attack of the first valve leaf 21 to the blood flow. The blood flow enters the flow blocking area and impacts the third valve leaf 23 of the valve flap 2 in the reverse direction, giving the third valve leaf 23 a force to rotate toward the inside of the inner cavity 10, causing the valve flap 2 to rotate toward the open position. During the rotation process, the first valve leaf 21 rotates toward the inside of the inner cavity 10 and gradually intervenes in the blood flow, which can also play a flow blocking role, and can further drive the valve flap 2 to rotate faster until it reaches the open position.

[0058] Thus, the two-way valve of the first embodiment of the present invention drives the valve flap 2 to rotate by the blood flow impacting the first valve leaf 21 and the third valve leaf 23 of the valve disc 2 when the blood flow direction changes, so that the valve flap 2 automatically rotates and switches between the closed position and the open position in accordance with the change in blood flow direction, thereby achieving timely and reliable switching response. In particular, by providing the third valve leaf 23 at the end of the first valve leaf 21 near the distal port 1b of the inner cavity 10 of the valve body 1, the angle of attack of the first valve leaf 21 to the blood flow is increased when blood flows from the distal port 1b of the inner cavity 10 to the proximal port 1a, thereby increasing the force and torque applied to the valve flap 2 under the action of the blood flow, thereby accelerating the response speed of the valve flap 2 from the closed position to the open position. At the same time, the valve flap 2 closes the window 1c on the valve body 1 in the closed position and separates the proximal port 1a and the distal port 1b of the inner cavity 10 in the open position, and the valve flap 2 is maintained in the closed position or the open position by the impact of the blood flow, thereby achieving a reliable and stable sealing effect. Therefore, the two-way valve of the first embodiment can achieve stable opening and closing, better switching response and sealing effect, and has better blood flow guiding capability.

[0059] The two-way valve of the first embodiment can be used for an interventional ventricular assist device. When in use, the two-way valve is installed on an interventional catheter and placed in the aorta. The proximal port 1a of the inner cavity 10 of the valve body 1 is connected to the left ventricle through a section of the interventional catheter, and the distal port 1b of the inner cavity 10 of the valve body 1 is connected to the ventricular assist pump through another section of the interventional catheter. The window 1c on the valve body 1 faces the aorta. When the ventricular assist pump draws out blood, the blood in the left ventricle flows from the proximal port 1a of the inner cavity 10 of the valve body 1 to the distal port 1b, causing the valve flap 2 to rotate to and remain in the closed position, and the two-way valve guides the blood flow from the left ventricle through the proximal port 1a and the distal port 1b of the inner cavity 10 of the valve body 1 into the ventricular assist pump; when the ventricular assist pump reinjects blood, the blood in the ventricular assist pump flows from the distal port 1b of the inner cavity 10 of the valve body 1 to the proximal port 1a, causing the valve flap 2 to rotate to and remain in the open position, and the two-way valve guides the blood flow from the ventricular assist pump through the distal port 1b of the inner cavity 10 of the valve body 1 and the window 1c of the valve body 1 to be ejected to the aorta, thereby achieving blood circulation assistance.

[0060] 3 to 6, in the first embodiment, preferably, the first valve leaf 21, the second valve leaf 22 and the third valve leaf 23 are all arc-shaped sheet structures. In the closed position, the first valve leaf 21 is convex toward the outside of the window 1c, and the first valve leaf 21 has a first arc-shaped convex surface 211 facing the outside of the window 1c and a first arc-shaped concave surface 212 facing the inside of the inner cavity 10 of the valve body 1 in the closed position; the second valve leaf 22 is convex toward the proximal port 1a of the inner cavity 10 of the valve body 1, and the second valve leaf 22 has a first arc-shaped concave surface 212 facing the proximal port 1a of the inner cavity 10 of the valve body 1 in the closed position. 1a and a second arc-shaped convex surface 221 facing the distal port 1b of the inner cavity 10 and a second arc-shaped concave surface 222 facing the distal port 1b of the inner cavity 10; the third valve leaf 23 has a first surface 231 facing the distal port 1b of the inner cavity 10 and a second surface 232 facing the proximal port 1a of the inner cavity 10. The arc-shaped sheet-shaped third valve leaf 23 is convex toward the distal port 1b of the inner cavity 10 of the valve body 1. When the third valve leaf 23 is in the closed position, the first surface 231 is an arc-shaped convex surface convex toward the distal port 1b of the inner cavity 10, and the second surface 232 is an arc-shaped concave surface recessed toward the proximal port 1a of the inner cavity 10. The first valve leaf 21 and the second valve leaf 22 have a smooth transition: the first curved convex surface 211 of the first valve leaf 21 and the second curved convex surface 221 of the second valve leaf 22 are smoothly connected, and the first curved concave surface 212 of the first valve leaf 21 and the second curved concave surface 222 of the second valve leaf 22 are smoothly connected. The first valve leaf 21 and the third valve leaf 23 have a smooth transition: the first curved convex surface 211 of the first valve leaf 21 and the first surface 231 of the third valve leaf 23 are smoothly connected, and the first curved concave surface 212 of the first valve leaf 21 and the second surface 232 of the third valve leaf 23 are smoothly connected. This ensures relatively gentle blood flow during each flushing, while reducing the formation of blood clots in narrow spaces.

[0061] Referring to Figure 9 , in the open position, the first curved convex surface 211 of the first valve leaf 21 and the first surface 231 of the third valve leaf 23 act as flow-blocking surfaces, impacted by blood flow flowing in from the distal port 1b of the inner cavity 10. This keeps the valve flap 2 in the open position and guides blood flow from the distal port 1b of the inner cavity 10 to the fenestration 1c. When the blood flow changes from the proximal port 1a of the inner cavity 10 to the distal port 1b, the first curved concave surface 212 of the first valve leaf 21 and the second surface 232 of the third valve leaf 23 act as flow-blocking surfaces, impacted by the blood flow, driving the valve flap 2 to rotate toward the closed position. During this rotation, the second valve leaf 22 gradually intersects the blood flow, and the second curved convex surface 221 of the second valve leaf 22 also acts as a flow-blocking surface until the valve flap 2 rotates to the closed position.

[0062] Referring to Figure 13 , in the closed position, the second curved convex surface 221 of the second valve leaf 22 and the second surface 232 of the third valve leaf 23 act as flow-blocking surfaces, impacted by blood flow from the proximal port 1a to the distal port 1b of the inner cavity 10 of the valve body 1, maintaining the valve flap 2 in the closed position. When the blood flow changes direction, from the distal port 1b to the proximal port 1a of the inner cavity 10, the first surface 231 of the third valve leaf 23 acts as a flow-blocking surface, impacted by the blood flow, driving the valve flap 2 to rotate toward the open position. During this rotation, the first valve leaf 21 gradually engages the blood flow, and the first curved convex surface 211 of the first valve leaf 21 also acts as a flow-blocking surface until the valve flap 2 rotates to the open position.

[0063] The first valve leaf 21, the second valve leaf 22 and the third valve leaf 23 all adopt an arc-shaped sheet structure, so that the surface that blocks the blood flow is an arc-shaped convex surface or an arc-shaped concave surface, which is beneficial to improving the blood flow blocking effect, realizing continuous diversion, minimizing the damage and impact on the blood flow, and is beneficial to blood flow stability and blood flow permeability, and is not prone to turbulence. It can simplify the flow channel while meeting the functional requirements, is more in line with hemodynamics, and can reduce the risk of thrombosis.

[0064] Referring to Figures 3 to 6, the valve flap 2 of the first embodiment of the present invention has an arc-shaped first valve leaf 21 and an edge connected to the edge of the arc-shaped third valve leaf 23 to form a first side edge 2a away from the second valve leaf 22, and the arc-shaped second valve leaf 22 has a second side edge 2b away from the first valve leaf 21.

[0065] 9 and 10 , when the valve flap 2 is in the open position, the first side edge 2a of the valve flap 2 is tangent to the wall of the inner cavity 10 at the lower part of the inner cavity 10 of the valve body 1 away from the window 1c, and the second side edge 2b of the valve flap 2 is in contact with the wall of the inner cavity 10 at the upper part of the inner cavity 10 close to the window 1c and closes the end of the window 1c close to the proximal port 1a of the inner cavity 10, so that the first side edge 2a and the second side edge 2b of the valve flap 2 are just in contact with the wall of the inner cavity 10 at an angle, thereby realizing that the first valve leaf 21, the second valve leaf 22 and the third valve leaf 23 of the valve flap 2 jointly separate the proximal port 1a and the distal port 1b of the inner cavity 10, thereby ensuring the sealing effect, which is beneficial for the blood pushed out of the ventricular assist pump to be ejected into the aorta when reinjecting blood, preventing blood from flowing back into the left ventricle, and avoiding additional load on the heart.

[0066] Referring to Figure 9, in this embodiment 1, preferably, when the valve flap 2 is in the open position, the second valve leaf 22 is located at one end of the window opening 1c close to the proximal port 1a of the inner cavity 10 and occupies part of the space of the window opening 1c, and the end of the window opening 1c close to the distal port 1b of the inner cavity 10 is connected to the distal port 1b of the inner cavity 10, so that blood can be ejected out of the window opening 1c. In a preferred embodiment, as shown in Figure 9, in the open position, the side of the second valve leaf 22 away from the first valve leaf 21 has an overlapping length in the axial direction with the wall of the inner cavity 10 of the valve body 1. The overlapping length allows the second valve leaf 22 to abut against the wall of the inner cavity 10 when it rotates toward the outside of the inner cavity 10, thereby positioning the second valve leaf 22 in the open position, and the side of the second valve leaf 22 away from the first valve leaf 21 closes the end of the opening window 1c close to the proximal port 1a of the inner cavity 10, and ensures the sealing effect, which can prevent blood from being ejected from the opening window 1c from re-entering the inner cavity 10 of the valve body 1 from the end of the opening window 1c close to the proximal port 1a of the inner cavity 10, that is, preventing blood from flowing back into the left ventricle from the opening window 1c when reinjecting blood. In other embodiments, the second side edge 2b of the second valve leaf 22 of the valve flap 2 may also just coincide with the inner side of the end of the window opening 1c close to the proximal end 1a of the inner cavity 10 of the valve body 1, thereby closing the end of the window opening 1c close to the proximal end 1a of the inner cavity 10 and ensuring the sealing effect.

[0067] 13 and 14 , when the valve flap 2 is in the closed position, a side portion of the first valve leaf 21 close to the second valve leaf 22 is located on the inner side of an end of the window opening 1c close to the proximal port 1a of the inner cavity 10, and a side portion of the first valve leaf 21 away from the second valve leaf 22 is located on the inner side of an end of the window opening 1c close to the distal port 1b of the inner cavity 10 and closes an end of the window opening 1c close to the distal port 1b, thereby achieving the closure of the window opening 1c by the first valve leaf 21 of the valve flap 2, which can ensure the sealing effect and facilitate the blood in the left ventricle to flow into the ventricular assist pump when blood is drawn out, preventing blood from being ejected into the aorta.

[0068] Referring to Figure 13, in this embodiment 1, when the valve flap 2 is in the closed position, a spacing space is preferably left between a side of the first valve leaf 21 close to the second valve leaf 22 and an end side of the opening window 1c close to the proximal port 1a of the inner cavity 10, so as to facilitate the rotation and switching position of the valve flap 2, and ensure that the connection between the first valve leaf 21 and the second valve leaf 22 does not exceed the outer contour of the valve body 1 during the rotation process, so as to avoid the valve flap 2 causing damage to the inner wall of the blood vessel during the rotation process. There is a very small amount of blood leakage in the spacing space, which does not affect the flow of blood in the left ventricle into the ventricular assist pump when blood is drawn out.

[0069] Referring to FIG. 14 , in this first embodiment, a gap is formed between the first side edge 2a, which is tangential to the wall of the inner cavity 10 in the open position of the valve flap 2, and the second side edge 2b, which is rotated to the closed position of the valve flap 2, and the wall of the inner cavity 10. This facilitates smooth rotation of the valve flap 2 within the inner cavity 10 of the valve body 1. When the valve flap 2 is in the closed position, the gap between the first side edge 2a and the wall of the inner cavity 10 does not affect the sealing of the window 1c by the first valve leaf 21. A very small amount of blood leaks from the gap between the second side edge 2b and the wall of the inner cavity 10, which does not affect the flow of blood from the left ventricle into the ventricular assist pump during blood withdrawal.

[0070] In the first embodiment of the present invention, the cross-sectional shape of the wall of the inner cavity 10 of the valve body 1 is preferably circular, and the edge contour of the first valve leaf 21 and the edge contour of the third valve leaf 23 constituting the first side edge 2a and the second side edge 2b contour of the second valve leaf 22 are all ellipses that can be obliquely cut and matched with the wall of the inner cavity 10.

[0071] Referring to Figure 6, in this embodiment 1, the angle between the first valve leaf 21 and the second valve leaf 22 of the valve disc 2 is β1. The angle β1 is the angle between the first curved convex surface 211 of the first valve leaf 21 and the second curved convex surface 221 of the second valve leaf 22, and is also the angle between the first curved concave surface 212 of the first valve leaf 21 and the second curved concave surface 222 of the second valve leaf 22. The value of the angle β1 is preferably 100°-160°, which is more conducive to relatively smooth blood flow each time and reducing the formation of blood clots in narrow spaces.

[0072] Referring to Figure 6, the angle between the first valve leaf 21 and the third valve leaf 23 of the valve disc 2 is β2. In the first embodiment, the angle β2 is the angle between the first curved convex surface 211 of the first valve leaf 21 and the first surface 231 of the third valve leaf 23, and is also the angle between the first curved concave surface 212 of the first valve leaf 21 and the second surface 232 of the third valve leaf 23. The value of the angle β1 is preferably 120°-175°, which is more conducive to relatively smooth blood flow each time and reducing the formation of thrombus in a small space.

[0073] In the first embodiment of the present invention, in order to make the window opening 1c of the valve body 1 better adapt to the arc-shaped first valve leaf 21 and second valve leaf 22 of the valve disc 2, referring to Figures 1 and 2, preferably, the window opening 1c of the valve body 1 includes a first oblique cut window surface 1c1, a flat cut window surface 1c2 and a second oblique cut window surface 1c3 that are connected in sequence and formed by continuous cutting on the valve body 1. The first oblique cut window surface 1c1 and the second oblique cut window surface 1c3 form an angle or are parallel to each other. The first oblique cut window surface 1c1 is close to the proximal end 1a of the inner cavity 10 of the valve body 1, and the second oblique cut window surface 1c3 is close to the distal end 1b of the inner cavity 10 of the valve body 1. Two flat window surfaces 1c2 are formed between the first beveled window surface 1c1 and the second beveled window surface 1c3. The first beveled window surface 1c1, the two flat window surfaces 1c2, and the second beveled window surface 1c3 are connected to form a closed annular shape. Both flat window surfaces 1c2 are parallel to the axis of the valve body 1 and are symmetrical about a centerline of symmetry. When the valve disc 2 is in the open position, the side of the second valve leaf 22 away from the first valve leaf 21 abuts against the wall of the inner cavity 10 inside the first beveled window surface 1c1 of the window 1c, ensuring a sealed seal. When the valve flap 2 is in the closed position, the side of the first valve leaf 21 away from the second valve leaf 22 is located on the inner side of the second oblique window surface 1c3 of the window opening 1c and closes the end of the window opening 1c close to the distal end 1b. The arc-shaped sheet-like first valve leaf 21 can form a relatively complete inner cavity 10 with the valve body 1 at the window opening 1c, thereby increasing the blood discharge volume when blood is drawn out.

[0074] In this first embodiment, referring to FIG3 , the first valve leaf 21 is provided with connecting portions 21b at each end. The two ends of the first valve leaf 21 refer to the two ends of the arc-shaped profile (arc) of the first valve leaf 21. The first side edge 2a and the second side edge 2b of the valve disc 2 are connected by the edges of the two connecting portions 21b to form a closed edge profile. Referring to FIG8 and FIG9 , the two connecting portions 21b of the first valve leaf 21 are rotatably connected to the valve body 1 via a pin 3. The axis of the pin 3 is perpendicular to the axis of the valve body 1 and the plane containing the symmetric centerlines of the two flat-cut window surfaces 1c2. In a preferred embodiment, the axis of the pin 3 intersects the axis of the valve body 1. The axis of the pin 3 (i.e., the rotation center of the valve disc 2) is positioned on the axis of the valve body 1. This fully considers the structure and movement of the valve disc 2 while also taking into account the fluid dynamics of the valve disc 2, thereby ensuring smooth rotation and switching of the valve disc 2. In other embodiments, the axis of the pin 3 can also be offset to the side of the axis of the valve body 1 away from the window 1c. The pin 3 is eccentrically arranged with respect to the axis of the valve body 1 on the side of the axis of the valve body 1 away from the window 1c, which is beneficial to increase the blood flow impact torque exerted on the second arc-shaped convex surface 221 of the second valve leaf 22 that gradually intervenes in the blood flow during the rotation of the valve flap 2 from the open position to the closed position, so that the valve flap 2 rotates quickly to the closed position and stably remains in the closed position. The distance that the pin 3 deviates from the axis of the valve body 1 on the side of the axis of the valve body 1 away from the window 1c is preferably 0.1mm-1mm.

[0075] Referring to Figures 10 and 14 , a gap 4 is defined between the two connecting portions 21b of the first valve leaf 21 and the wall of the inner cavity 10 of the valve body 1 . This gap 4 exists when the valve flap 2 is in both the open and closed positions. This gap 4 prevents the formation of thrombi in the stagnant area between the valve flap 2 and the wall of the inner cavity 10 of the valve body 1 , where blood is prone to coagulation. Furthermore, when the valve flap 2 is in the open position, blood flow can re-flushe this stagnant area through the gap 4 , further reducing thrombosis. When the valve flap 2 is in the open position, a very small amount of blood leaks through this gap 4 , which does not affect the flow of blood from the ventricular assist pump into the fenestration 1c and into the aorta during reinjection.

[0076] In the first embodiment, to prevent the first valve leaf 21 of the valve flap 2 from extending beyond the outer contour of the valve body 1 and damaging the inner wall of the blood vessel when the valve flap 2 rotates from the open position to the closed position, a limiting structure is provided in the window 1c of the valve body 1 to limit the rotation of the first valve leaf 21 of the valve flap 2 toward the outside of the inner cavity 10, that is, to define the closed position. In the first embodiment, referring to FIG13 , preferably, in the closed position, a side of the first valve leaf 21 away from the second valve leaf 22 abuts against the wall of the inner cavity 10. Specifically, a side of the first curved convex surface 211 of the first valve leaf 21 near the first side edge 2a abuts against the wall of the inner cavity 10 on the inner side of the second oblique window surface 1c3 of the window 1c. This prevents the first valve leaf 21 from continuing to rotate toward the outside of the inner cavity 10 after the valve flap 2 rotates to the closed position, so that the valve flap 2 remains positioned relative to the valve body 1 in the closed position and is located within the inner cavity 10 of the valve body 1, without extending beyond the outer contour of the valve body 1. This not only limits the closed position of the valve flap 2, but also allows the side of the first valve leaf 21 away from the second valve leaf 22 to abut against the wall of the inner cavity 10, thereby enabling the side of the first valve leaf 21 away from the second valve leaf 22 to close the end of the window 1c near the distal end 1b, that is, the first valve leaf 21 closes the window 1c when the valve flap 2 is in the closed position. In this first embodiment, in the closed position, the side of the first valve leaf 21 away from the second valve leaf 22 and the wall of the inner cavity 10 of the valve body 1 have an axial overlap length X. This overlap length X allows the first valve leaf 21 to abut against the wall of the inner cavity 10 when it rotates outward from the inner cavity 10, thereby limiting the first valve leaf 21 to the closed position.

[0077] Referring to Figure 15, in this embodiment 1, the rotation angle of the valve flap 2 from the closed position to the open position is α, and the value of the angle α is preferably 25°-60°, which is conducive to the valve flap 2 allowing the blood to flow smoothly through the first curved convex surface 211 of the first valve leaf 21 of the valve flap 2 and be ejected from the valve body 1 window 1c to the aorta when the valve flap 2 is in the open position, thereby ensuring the fluidity of the blood flow in the channel from the distal end 1b of the inner cavity 10 of the valve body 1 to the window 1c.

[0078] In the first embodiment, preferably, the first valve leaf 21 , the second valve leaf 22 and the third valve leaf 23 of the valve disc 2 are integrally formed as a single piece.

[0079] Referring to Figure 15, in this first embodiment, preferably, the valve body 1 has a middle section 11, and the window 1c is provided in the middle section 11. The outer contour of the middle section 11 is an arc shape with a maximum diameter distance D. Preferably, the cross-sectional shapes of the inner contour and the outer contour of the middle section 11 are both circular, that is, the middle section 11 is a hollow cylinder. The two ends of the middle section 11 of the valve body 1 are respectively provided with a proximal section 12 and a distal section 13. The proximal section 12, the middle section 11 and the distal section 13 are integrally formed as a single piece. The proximal section 12 and the distal section 13 are respectively used to connect to the interventional catheter. The inner contour and the outer contour of the proximal section 12 and the distal section 13 are both circular to facilitate assembly with the interventional catheter. The outer contour of the middle section 11 protrudes from the outer contours of the proximal section 12 and the distal section 13, thereby forming a step between the proximal section 12 and the distal section 13. When the outer contour of the middle section 11 is circular, the maximum diameter of the outer contour of the middle section 11 is the diameter of the circular outer contour, D. Diameter D is compatible with the outer diameter of the interventional catheter and is preferably between 10Fr and 24Fr, and optimally between 14Fr and 21Fr. The outer contours of the proximal and distal sections 12 and 13 have the same diameter, d. Diameter d is preferably between 0.7D and 0.95D, facilitating bonding of the valve body 1 to the interventional catheter via the proximal and distal sections 12 and 13. The inner contours of the proximal, middle, and distal sections 12, 11, and 13 have the same diameter and together form the wall of the inner cavity 10 of the valve body 1.

[0080] Preferably, the size of the gap 4 between the two connecting portions 21b of the first valve leaf 21 and the wall of the inner cavity 10 of the valve body 1 is D / 50-D / 100, so as to ensure that the blood leakage in the gap 4 is very small.

[0081] Preferably, in the closed position, the axial overlapping length X between the side of the first valve leaf 21 away from the second valve leaf 22 and the wall of the inner cavity 10 of the valve body 1 is preferably 0.1D-0.8D to ensure the limiting function and the sealing effect.

[0082] Referring to Figure 6 , the length of the first valve leaf 21 is L1. The length L1 of the first valve leaf 21 refers to the distance between the end where the first valve leaf 21 is connected to the second valve leaf 22 and the end where the first valve leaf 21 is connected to the third valve leaf 23. The value of length L1 is preferably 0.5D-1.5D. The length of the second valve leaf 22 is L2. The length L2 of the second valve leaf 22 refers to the distance between the end where the second valve leaf 22 is connected to the first valve leaf 21 and the end of the first valve leaf 21 away from the first valve leaf 21. The value of length L2 is preferably 0.1D-0.6D. The length of the third valve leaf 23 is L3. The length L3 of the third valve leaf 23 refers to the distance between the end of the third valve leaf 23 connected to the first valve leaf 21 and the side tip of the third valve leaf 23 away from the first valve leaf 21. The value of length L3 is preferably 0.1D-0.8D. The length L2 of the second valve leaf 22 is less than the length L3 of the third valve leaf 23. The ratio of the length L2 of the second valve leaf 22 to the length L3 of the third valve leaf 23 is preferably 1 / 5-1 / 2. Preferably, the area ratio of the first valve leaf 21 to the second valve leaf 22 is 1 / 5-1 / 7, and the area ratio of the third valve leaf 23 to the first valve leaf 21 is 1 / 3-1 / 6.

[0083] 6 , a rounded corner with a radius of r1 is formed between the first and second valve leaves 21 and 22, with a preferred range of D / 4 to D / 9. A rounded corner with a radius of r2 is formed between the third valve leaf 23 and the first valve leaf 21, with a preferred range of D / 5 to D / 8.

[0084] 6 , in the closed position, the maximum length of the valve disc 2 as a whole extending axially along the valve body 1 is N, and the length N is preferably 1.5D-2D; the maximum height of the valve disc 2 as a whole extending radially along the valve body 1 is M, and the height M is preferably 0.5D-0.7D; the spacing between the side tip of the end of the third valve leaf 23 away from the first valve leaf 21 and the axis of the pin 3 along the axial direction of the valve body 1 is L4, and the spacing L4 is also the farthest distance of the third valve leaf 23 from the axis of the pin 3 along the axial direction of the valve body 1, and the spacing L4 is preferably 1D-1.7D; the spacing between the side tip of the end of the second valve leaf 22 away from the first valve leaf 21 and the axis of the pin 3 along the axial direction of the valve body 1 is L5, and the spacing L5 is also the farthest distance of the second valve leaf 22 from the axis of the pin 3 along the axial direction of the valve body 1. The sum of the spacings L4 and L5 is the maximum length N of the valve disc 2 as a whole extending axially along the valve body 1.

[0085] Referring to Figure 2 , in this first embodiment, the angle δ between the first oblique cut window surface 1c1 of the window opening 1c of the valve body 1 and a vertical plane perpendicular to the axis of the valve body 1 is preferably 0. This angle δ should not be too large, so that the second side edge 2b of the second valve leaf 22 can be in contact with the inner cavity 10 wall inside the first oblique cut window surface 1c1 of the window opening 1c when the valve flap 2 is in the open position. This angle δ also limits the height M of the valve flap, preventing the second valve leaf 22 from obstructing blood flow excessively when the valve flap 2 is in the closed position. Therefore, the angle δ is preferably between 0 and 45°. The angle ε between the second oblique cut window surface 1c3 of the window opening 1c of the valve body 1 and a vertical plane perpendicular to the axis of the valve body 1 is preferably 0 to 80°. The flat cut window surface 1c2 of the window opening 1c of the valve body 1 extends along the axial direction of the valve body 1 for a length P, preferably between 0.5D and 1.5D. Length P, angle δ, and angle ε collectively determine the size of window 1c of valve body 1, which in turn determines the amount of blood discharged during each stroke. The maximum axial length of window 1c of valve body 1 is O, with length O preferably ranging from 0.8D to 2D. Furthermore, the ratio of length P to length O is preferably 1 / 4 to 1.

[0086] Of course, the above-mentioned dimensional parameters of the two-way valve of the first embodiment are not limited and can be further adjusted and optimized according to actual usage.

[0087] Example 2

[0088] As shown in Figures 16 to 21, a second embodiment of the two-way valve provided by the present invention is provided. This second embodiment is substantially identical to the first embodiment, and the similarities are not repeated here. The difference is that the shape of the third valve leaf 23 of the valve disc 2 in this second embodiment is different from that in the first embodiment. Specifically, in this second embodiment, the third valve leaf 23 is a slightly arched, planar, sheet-like structure. In the closed position, the third valve leaf 23 is slightly convex toward the proximal end 1a of the inner cavity 10 of the valve body 1. That is, the third valve leaf 23 is a planar sheet-like structure that is slightly convex toward the proximal end 1a of the inner cavity 10 of the valve body 1. In this way, when the third valve leaf 23 is in the closed position, the first surface 231 of the third valve leaf 23 is a substantially flat surface that is slightly concave toward the distal end 1b of the inner cavity 10, and the second surface 232 is a substantially flat surface that is slightly convex toward the proximal end 1a of the inner cavity 10. At this time, the length of the third valve leaf 23 is L3, which refers to the interval length between the end of the third valve leaf 23 connected to the first valve leaf 21 and the side tip of the end of the third valve leaf 23 away from the first valve leaf 21. The angle β2 between the first valve leaf 21 and the third valve leaf 23 is the angle between the length extension line of the third valve leaf 23 and the first valve leaf 21.

[0089] In other embodiments, the third valve leaf 23 may also be a planar sheet structure, in which case both the first surface 231 and the second surface 232 of the third valve leaf 23 are planes.

[0090] Compared with the third valve leaf 23 in Example 1 which adopts an arc-shaped sheet structure, the third valve leaf 23 in this Example 2 adopts a micro-arched flat sheet structure or a flat sheet structure, which can further increase the angle of attack of the first valve leaf 21 to the blood flow when the blood flows from the distal port 1b of the inner cavity 10 to the proximal port 1a, reduce blood flow diversion, and make the valve flap 2 subject to greater force and torque under the action of blood flow, and the response speed of the valve flap 2 to switch from the closed position to the open position is faster and more agile.

[0091] Example 3

[0092] Based on the two-way valve of the present invention, the present invention also provides a pulsating interventional ventricular assist device. As shown in Figure 22, Example 3 provides an embodiment of the pulsating interventional ventricular assist device of the present invention. The pulsating interventional ventricular assist device of this embodiment 3 adopts any of the two-way valves described in the above-mentioned Examples 1 and 2. Since the two-way valve can achieve stable opening and closing and better switching response and sealing effect, it has better blood flow guiding ability, so that the working ability and operating effect of the pulsating interventional ventricular assist device of this embodiment 3 are effectively improved and optimized.

[0093] Specifically, the pulsatile interventional ventricular assist device of the third embodiment includes a ventricular catheter 100, a two-way valve 200, a peripheral catheter 300, a pump 400, and an external control device (not shown in the figure) that controls the pump 400 to extract and reinject blood, which are connected in sequence. The two-way valve 200 adopts the two-way valve of the present invention and can be any of the two-way valves described in the above-mentioned embodiments one and two. The ventricular catheter 100 is delivered to the left ventricle of the heart 600 via the femoral artery 500. One end of the ventricular catheter 100 is connected to the left ventricle, and the other end of the ventricular catheter 100 is preferably connected to the proximal section 12 of the two-way valve 200 by bonding or injection molding, thereby communicating with the proximal port 1a of the inner cavity 10 of the valve body 1. The two-way valve 200 is located in the aorta 700. The diameter of the peripheral catheter 300 matches that of the ventricular catheter 100. One end of the peripheral catheter 300 is preferably bonded or injection-molded to the distal portion 13 of the two-way valve 200, thereby communicating with the distal port 1b of the inner cavity 10 of the valve body 1. The other end of the peripheral catheter 300 is preferably bonded to the pump 400. The pump 400 is preferably a diaphragm pump, which is controlled and driven by an external control device to pump blood out and reinject blood at a set pulsating frequency. Both the diaphragm pump and its external control device can be existing devices and are not described in detail herein.

[0094] The operating principle of the pulsatile interventional ventricular assist device of this third embodiment is as follows: an external control device provides a set pulse to the pump 400, causing the pump 400 to change the direction of blood flow during blood extraction and reinjection. The pulse set by the external control device synchronizes with the heart 600 to "push and pull" the pump 400, achieving blood extraction and reinjection. During myocardial contraction, blood flows through the tip of the ventricular catheter 100 located in the left ventricle and enters the two-way valve 200. Blood flows from the proximal port 1a of the inner cavity 10 of the valve body 1 to the distal port 1b. The blood impacts the first curved concave surface 212 of the first leaflet 21 of the valve disc 2, the second surface 232 of the third leaflet 23, and the second curved convex surface 221 of the second leaflet 22. This drives the first leaflet 21 of the valve disc 2 to rotate about the pin 3 toward the outside of the inner cavity 10 of the valve body 1 to a closed position, sealing the window 1c of the valve body 1. Blood then flows from the proximal port 1a of the inner cavity 10 of the valve body 1 to the distal port 1b and is drawn into the pump 400 through the peripheral catheter 300. The external control device sets a pulse for the pump 400, so that the blood in the pump 400 is returned to the peripheral catheter 300 and enters the two-way valve 200. When the blood just enters the distal port 1b of the inner cavity 10 of the valve body 1, the valve flap 2 is still in the closed position. When the blood flows back into the inner cavity 10 of the valve body 1, it impacts the first surface 231 of the third valve leaf 23 of the valve flap 2 and the first curved convex surface 211 of the first valve leaf 21, driving the first valve leaf 21 of the valve flap 2 to rotate around the pin 3 toward the inner side of the inner cavity 10 of the valve body 1 to the open position. At this time, when the myocardium relaxes, the blood is ejected laterally from the open window 1c of the valve body 1 to the aorta 700, completing a cycle.

[0095] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and substitutions can be made without departing from the technical principles of the present invention. These improvements and substitutions should also be regarded as the scope of protection of the present invention.

Claims

1. A two-way valve, characterized in that, include: A valve body (1) is axially penetrated to form an inner cavity (10) having a proximal port (1a) and a distal port (1b); a window (1c) is provided on the valve body (1) between the proximal port (1a) and the distal port (1b); the window (1c) communicates the inner cavity (10) with the outside of the valve body (1); a valve flap (2) disposed in the inner cavity (10) and rotatably connected to the valve body (1), the valve flap (2) comprising a first valve leaf (21) disposed at the opening window (1c), a second valve leaf (22) connected at an obtuse angle to an end of the first valve leaf (21) close to the proximal port (1a) on a side of the first valve leaf (21) close to the inner cavity (10), and a third valve leaf (23) connected at an obtuse angle to an end of the first valve leaf (21) close to the distal port (1b) on a side of the first valve leaf (21) close to the inner cavity (10); The valve flap (2) is impacted by the blood flow axially flowing in the inner cavity (10) and rotates back and forth between an open position and a closed position; In the open position, the second valve leaf (22), the first valve leaf (21) and the third valve leaf (23) jointly separate the proximal port (1a) and the distal port (1b), and the opening window (1c) is opened and communicated with the distal port (1b); In the closed position, the first valve leaf (21) closes the open window (1c), and the proximal port (1a) and the distal port (1b) are in communication.

2. The two-way valve according to claim 1, characterized in that, The first valve leaf (21) and the second valve leaf (22) are both arc-shaped sheet structures. In the closed position, the first valve leaf (21) is convex toward the outer side of the opening window (1c), and the second valve leaf (22) is convex toward the proximal port (1a). There is a smooth transition between the first valve leaf (21) and the second valve leaf (22); The third valve leaf (23) is an arc-shaped sheet structure. In the closed position, the third valve leaf (23) is convex toward the distal end (1b), and there is a smooth transition between the first valve leaf (21) and the third valve leaf (23); Alternatively, the third valve leaf (23) is a slightly arched flat sheet structure, and in the closed position, the third valve leaf (23) is slightly protruding toward the proximal port (1a); Alternatively, the third valve leaf (23) is a planar sheet structure.

3. The two-way valve according to claim 2, characterized in that, The edge of the first valve leaf (21) and the edge of the third valve leaf (23) are connected to form a first side edge (2a) away from the second valve leaf (22), and the second valve leaf (22) has a second side edge (2b) away from the first valve leaf (21). In the open position, the first side edge (2a) is tangent to the wall of the inner cavity (10), and the second side edge (2b) is in contact with the wall of the inner cavity (10) and closes one end of the opening window (1c) close to the proximal port (1a).

4. The two-way valve according to claim 2, characterized in that, The opening window (1c) includes a first beveled opening surface (1c1), a flat opening surface (1c2), and a second beveled opening surface (1c3) that are successively connected and formed by continuous cutting on the valve body (1). The first beveled opening surface (1c1) and the second beveled opening surface (1c3) form an angle or are parallel to each other. There are two flat opening surfaces (1c2), and both of the two flat opening surfaces (1c2) are parallel to the axis of the valve body (1) and symmetric about a symmetry center line.

5. The two-way valve according to claim 4, characterized in that, Connecting portions (21b) are respectively provided at both ends of the first valve leaf (21). The connecting portions (21b) are rotatably connected to the valve body (1) through a pin shaft (3). The axis of the pin shaft (3) is perpendicular to the plane where the axis of the valve body (1) and the symmetry center line of the two flat opening surfaces (1c2) are located. The axis of the valve body (1) intersects with the axis of the valve body (1), or the axis of the pin shaft (3) is offset to the side of the axis of the valve body (1) away from the opening window (1c).

6. The two-way valve according to claim 5, characterized in that, There is a gap (4) between the connecting portion (21b) and the wall of the inner cavity (10).

7. The two-way valve according to claim 6, characterized in that, The valve body (1) has a middle section (11). The opening window (1c) is provided on the middle section (11). The cross-sectional shape of the outer peripheral contour of the middle section (11) is an arc-shaped shape with a maximum diameter distance of D. The size of the gap (4) is D / 50 - D / 100.

8. The two-way valve according to claim 5, characterized in that, The valve body (1) has a middle section (11). The opening window (1c) is provided on the middle section (11). The cross-sectional shape of the outer peripheral contour of the middle section (11) is an arc-shaped shape with a maximum diameter distance of D. In the closed position, the maximum length of the valve flap (2) extending along the axial direction of the valve body (1) as a whole is 1.5D - 2D, the maximum height of the valve flap (2) extending along the radial direction of the valve body (1) as a whole is 0.5D - 0.7D, and the axial distance between the tip of the end side of the third valve leaf (23) away from the first valve leaf (21) and the axis of the pin shaft (3) is 1D - 1.7D.

9. The two-way valve according to claim 4, characterized in that, The angle between the first beveled opening surface (1c1) and the vertical plane perpendicular to the axis of the valve body (1) is 0 - 45°. The angle between the second beveled opening surface (1c3) and the vertical plane perpendicular to the axis of the valve body (1) is 0 - 80°. The valve body (1) has a middle section (11). The opening window (1c) is provided on the middle section (11). The cross-sectional shape of the outer peripheral contour of the middle section (11) is an arc-shaped shape with a maximum diameter distance of D. The length of the flat opening surface (1c2) extending along the axial direction of the valve body (1) is P, and the value of the length P is 0.5D - 1.5D. The maximum length of the opening window (1c) extending along the axial direction of the valve body (1) is O, and the value of the length O is 0.8D - 2D. The ratio of the length P to the length O is 1 / 4 - 1.

10. The two-way valve according to any one of claims 1 to 6, characterized in that, In the closed position, the side of the first valve leaf (21) away from the second valve leaf (22) abuts against the wall of the inner cavity (10).

11. The two-way valve according to any one of claims 1 to 6, characterized in that, The included angle between the first valve leaf (21) and the second valve leaf (22) is 100° - 160°.

12. The two-way valve according to any one of claims 1 to 6, characterized in that, The included angle between the first valve leaf (21) and the third valve leaf (23) is 120° - 175°.

13. The two-way valve according to any one of claims 1 to 6, characterized in that, The valve body (1) has a middle section (11), the opening window (1c) is provided on the middle section (11), the cross-sectional shape of the outer peripheral contour of the middle section (11) is circular and the diameter is D, the length of the first valve leaf (21) is 0.5D - 1.5D, the length of the second valve leaf (22) is 0.1D - 0.6D, the length of the third valve leaf (23) is 0.1D - 0.8D, and the ratio of the length of the second valve leaf (22) to the length of the third valve leaf (23) is 1 / 5 - 1 / 2.

14. The two-way valve according to any one of claims 1 to 6, characterized in that, The rotation angle of the valve flap (2) from the closed position to the open position is 25° - 60°.

15. A pulsatile percutaneous ventricular assist device, characterized in that, Adopt the two-way valve according to any one of claims 1 to 14.

Images