Pulsation intervention type ventricular auxiliary device and two-way valve thereof

Abstract

The invention relates to the technical field of ventricular auxiliary devices, in particular to a two-way valve and a pulse intervention type ventricular auxiliary device adopting the two-way valve. The two-way valve comprises a valve body, an inner cavity with a near port and a far port is formed in the valve body in the axial direction in a penetrating mode, and a window communicated with the inner cavity and the exterior of the valve body is formed in the valve body; the valve clack is arranged in the inner cavity and rotationally connected with the valve body, the valve clack comprises a first valve blade and a second valve blade which are connected at an obtuse angle, the first valve blade is arranged at the window, and the second valve blade is arranged on one side, close to the inner cavity, of one end, close to the near port, of the first valve blade; the valve clack is impacted by the blood flow axially flowing in the inner cavity to rotate and switch back and forth between an opening position and a closing position; at the opening position, the first valve blade and the second valve blade jointly separate the near port from the far port, and the window is opened and communicated with the far port; and at the closing position, the first valve blade closes the opening window, and the near port is communicated with the far port. Better switching response and sealing effects can be achieved, and better blood flow guiding capacity is achieved.

Description

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] The interventional ventricular assist device (pVAD) has the advantages of less trauma, fewer complications and simple operation. By effectively supporting the circulatory system, it can correct the rapidly deteriorating hemodynamic disorders, improve tissue perfusion, and gain precious rescue time for patients. The pVAD is a device for short- and medium-term use, and its indications mainly target intraoperative support for high-risk PCI patients and rehabilitation treatment for cardiogenic shock patients.

[0003] The interventional ventricular assist device usually connects a ventricular assist pump to the left ventricle through an interventional catheter, sets a two-way valve on the interventional catheter, and locates the two-way valve in the ascending aorta. The external diaphragm pump with a set pulse frequency and the catheter connected through a connector are used to extract and reinject blood, and cooperate with the two-way valve to achieve blood flow guidance: when extracting blood, the blood in the left ventricle flows into the external diaphragm pump through the interventional catheter and the two-way valve; when reinjecting blood, the blood in the diaphragm pump flows into the interventional catheter under pressure. At this time, the two-way valve automatically changes direction due to the pressure, so that the blood is ejected from the catheter into the aorta. Thus, left ventricular assistance is achieved.

[0004] Therefore, the performance of the two-way valve is crucial to the operation effect of the interventional ventricular assist device. By improving the two-way valve to enhance and optimize its commutation response and sealing effect, the working ability and operation effect of the interventional ventricular assist device can be improved and optimized. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a two-way valve with stable opening and closing, having better commutation response and sealing effect.

[0006] To solve the above technical problem, the present invention adopts the following technical solutions:

[0007] The present invention provides a two-way valve, comprising: a valve body, which is axially penetrated inside to form an inner cavity having a near port and a far port, and an opening window is provided on the valve body between the near port and the far port, and the opening window communicates the inner cavity with the outside of the valve body; a valve flap, which is arranged in the inner cavity and rotatably connected to the valve body, the valve flap includes a first valve leaf and a second valve leaf connected at an obtuse angle, the first valve leaf is arranged at the opening window, and the second valve leaf is arranged at one end of the first valve leaf close to the near port and on the side of the first valve leaf close to the inner cavity; the valve flap is impacted by the blood flow axially flowing in the inner cavity and rotates back and forth between an open position and a closed position; in the open position, the first valve leaf and the second valve leaf together block the near port and the far port, and the opening window is opened and communicates with the far port; in the closed position, the first valve leaf closes the opening window, and the near port and the far port are communicated.

[0008] Preferably, both the first valve leaf and the second valve leaf are arc-shaped sheet structures. In the closed position, the first valve leaf protrudes toward the outside of the opening window, the second valve leaf protrudes toward the near port, and there is a smooth transition between the first valve leaf and the second valve leaf.

[0009] Preferably, in the open position, the first side edge of the first valve leaf away from the second valve leaf is tangent to the inner cavity wall, and the second side edge of the second valve leaf away from the first valve leaf contacts the inner cavity wall and closes one end of the opening window close to the near port.

[0010] Preferably, the opening window includes a first inclined cutting opening surface, a flat cutting opening surface, and a second inclined cutting opening surface that are successively connected and formed by continuously cutting on the valve body. The first inclined cutting opening surface and the second inclined cutting opening surface form an angle or are parallel to each other. There are two flat cutting opening surfaces, and both flat cutting opening surfaces are parallel to the axis of the valve body and symmetric about a symmetry center line.

[0011] Preferably, connecting parts are respectively provided at both ends of the first valve leaf, and the connecting parts are rotatably connected to the valve body through a pin shaft. The axis of the pin shaft is perpendicular to the plane where the axis of the valve body and the symmetry center line of the two flat cutting opening surfaces are located. The axis of the pin shaft is offset to the side of the valve body away from the opening window, or the axis of the pin shaft intersects with the axis of the valve body.

[0012] Preferably, there is a gap between the connecting part and the inner cavity wall.

[0013] Preferably, the valve body has a middle section part, the opening window is arranged in the middle section part, the cross-sectional shape of the outer peripheral contour of the middle section part is a shape with an arc and the maximum diameter distance is D, and the size of the gap is D / 50 - D / 100.

[0014] Preferably, the included angle between the first beveled window surface and the vertical plane perpendicular to the axis of the valve body is 0-45°, and the included angle between the second beveled window surface and the vertical plane perpendicular to the axis of the valve body is 0-80°; the valve body has a middle section, the window opening is provided in the middle section, the cross-sectional shape of the outer peripheral contour of the middle section is a shape with an arc and the maximum diameter distance is D, the length of the flat window surface extending along the axial direction of the valve body is P, the value of the length P is 0.5D-1.5D, the maximum length of the window opening extending along the axial direction of the valve body is O, the value of the length O is 0.8D-2D, and the ratio of the length P to the length O is 1 / 4-1.

[0015] Preferably, in the closed position, the side of the first valve flap away from the second valve flap abuts against the inner cavity wall.

[0016] Preferably, the included angle between the first valve flap and the second valve flap is 100°-160°.

[0017] Preferably, the rotation angle of the first valve flap from the position parallel to the axis of the valve body to the open position is 20°-60°.

[0018] The present invention also provides a pulsatile interventional ventricular assist device using the two-way valve as described above.

[0019] Compared with the prior art, the present invention has significant progress:

[0020] For the two-way valve of the present invention, when the blood flow direction changes, the blood flow impacts the first valve flap and the second valve flap of the valve flap, driving the valve flap to rotate, so that the valve flap automatically rotates and switches between the closed position and the open position in cooperation with the change of the blood flow direction, and timely and reliable switching response can be achieved. At the same time, by closing the window opening on the valve body in the closed position and separating the near port and the far port of the inner cavity in the open position by the valve flap, and keeping the valve flap in the closed position or the open position by the impact of the blood flow, a reliable and stable sealing effect can be achieved. 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

[0021] Figure 1 is a three-dimensional structural schematic diagram of the valve body of the two-way valve according to an embodiment of the present invention.

[0022] Figure 2 is a front view schematic diagram of the valve body of the two-way valve according to an embodiment of the present invention.

[0023] Figure 3 is a three-dimensional structural schematic diagram of one perspective of the valve flap of the two-way valve according to an embodiment of the present invention.

[0024] Figure 4 is a three-dimensional structural schematic diagram of another perspective of the valve flap of the two-way valve according to an embodiment of the present invention.

[0025] Figure 5 It is the front view schematic diagram of the valve flap of the two-way valve according to the embodiment of the present invention.

[0026] Figure 6 It is the top view schematic diagram of the valve flap of the two-way valve according to the embodiment of the present invention.

[0027] Figure 7 It is the three-dimensional schematic diagram of the two-way valve according to the embodiment of the present invention when the valve flap is in the open position.

[0028] Figure 8 It is the top view schematic diagram of the two-way valve according to the embodiment of the present invention when the valve flap is in the open position.

[0029] Figure 9 It is Figure 8 The cross-sectional schematic diagram along the A-A direction in

[0030] Figure 10 It is the left view schematic diagram of the two-way valve according to the embodiment of the present invention when the valve flap is in the open position.

[0031] Figure 11 It is the three-dimensional schematic diagram of the two-way valve according to the embodiment of the present invention when the valve flap is in the closed position.

[0032] Figure 12 It is the top view schematic diagram of the two-way valve according to the embodiment of the present invention when the valve flap is in the closed position.

[0033] Figure 13 It is Figure 12 The cross-sectional schematic diagram along the B-B direction in

[0034] Figure 14 It is the left view schematic diagram of the two-way valve according to the embodiment of the present invention when the valve flap is in the closed position.

[0035] Figure 15 It is the cross-sectional schematic diagram of the two-way valve according to the embodiment of the present invention when the first valve leaf of the valve flap is parallel to the axis of the valve body.

[0036] Figure 16 It is the left view schematic diagram of the two-way valve according to the embodiment of the present invention when the first valve leaf of the valve flap is parallel to the axis of the valve body.

[0037] Figure 17 It is the structural schematic diagram of the pulsatile interventional ventricular assist device according to the embodiment of the present invention.

[0038] Among them, the reference numerals are explained as follows:

[0039] 1 Valve body

[0040] 10 Inner cavity

[0041] 1a Near port

[0042] 1b Distal port

[0043] 1c Window opening

[0044] 1c1 First beveled window surface

[0045] 1c2 Flat window surface

[0046] 1c3 Second beveled window surface

[0047] 11 Middle section

[0048] 12 Proximal section

[0049] 13 Distal section

[0050] 2 Flap

[0051] 21 First valve leaf

[0052] 21a First side edge

[0053] 21b Connecting part

[0054] 211 First arc convex surface

[0055] 212 First arc concave surface

[0056] 22 Second valve leaf

[0057] 22a Second side edge

[0058] 221 Second arc convex surface

[0059] 222 Second arc concave surface

[0060] 3 Pin shaft

[0061] 4 Gap

[0062] 100 Ventricular catheter

[0063] 200 Two-way valve

[0064] 300 Peripheral catheter

[0065] 400 Pump

[0066] 500 Femoral artery

[0067] 600 Heart

[0068] 700 Aorta Detailed implementation manners

[0069] The following further elaborates the detailed implementation manners of the present invention in conjunction with the accompanying drawings. These implementation manners are only used to illustrate the present invention and are not intended to limit the present invention.

[0070] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "center", "longitudinal", "transverse", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present invention. In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.

[0071] In the description of the present invention, it should be noted that unless otherwise clearly specified and defined, the terms "installed", "connected", and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

[0072] In addition, in the description of the present invention, unless otherwise stated, the meaning of "a plurality of" is two or more.

[0073] As Figures 1 to 16 shown, it is an embodiment of the two-way valve provided by the present invention. The two-way valve of this embodiment includes a valve body 1 and a valve flap 2.

[0074] Among them, an inner cavity 10 is formed axially through inside the valve body 1. The inner cavity 10 has a near port 1a and a far port 1b that are opposite and communicate with each other along the axial direction of the valve body 1. An opening window 1c is provided on the valve body 1 between the near port 1a and the far port 1b. The opening window 1c communicates the inner cavity 10 of the valve body 1 with the outside of the valve body 1.

[0075] The valve flap 2 is arranged inside the inner cavity 10 of the valve body 1, and the valve flap 2 is rotatably connected to the valve body 1. The valve flap 2 includes a first valve leaf 21 and a second valve leaf 22 that are connected at an obtuse angle. The first valve leaf 21 is arranged at the opening window 1c of the inner cavity 10 of the valve body 1, and the first valve leaf 21 is used to close the opening window 1c. The second valve leaf 22 is arranged at one end of the first valve leaf 21 close to the near port 1a of the inner cavity 10 of the valve body 1, and the second valve leaf 22 is located on the side of the first valve leaf 21 close to the inner cavity 10 of the valve body 1. The valve flap 2 is impacted by the blood flow flowing axially in the inner cavity 10 and rotates back and forth between the open position and the closed position.

[0076] See 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 open window 1c close to the near port 1a of the inner cavity 10 of the valve body 1, and the first valve leaf 21 of the valve flap 2 is located in the inner cavity 10 of the valve body 1. The first valve leaf 21 and the second valve leaf 22 of the valve flap 2 jointly block the near port 1a and the far port 1b of the inner cavity 10, and the open window 1c is opened and connected to the far port 1b. At this time, the inner cavity 10 of the valve body 1 is not conducting, and the blood entering the valve body 1 from the far port 1b can flow out from the open window 1c. At this time, the two-way valve guides the blood flow to flow from the far port 1b of the inner cavity 10 to the open window 1c. Through the impact of the blood flow on the first valve leaf 21 of the valve flap 2, the valve flap 2 can be kept in the open position. When the blood flow direction changes to flow from the near port 1a of the inner cavity 10 to the far port 1b, the blood flow reversely impacts the first valve leaf 21 of the valve flap 2, giving the first valve leaf 21 a force to rotate outwardly of the inner cavity 10, causing the valve flap 2 to rotate towards the closed position. During the rotation process, the second valve leaf 22 rotates inwardly of the inner cavity 10 and gradually intervenes in the blood flow, which can also play a role in blocking the flow, and can further drive the valve flap 2 to rotate faster until it reaches the closed position.

[0077] See Figures 11 to 14 , in the closed position, the first valve leaf 21 of the valve flap 2 is located at the open window 1c, and the second valve leaf 22 of the valve flap 2 is located in the inner cavity 10 of the valve body 1. The first valve leaf 21 of the valve flap 2 closes the open window 1c, and the near port 1a and the far port 1b are connected, so that the inner cavity 10 of the valve body 1 is conducting, and the blood can flow axially through the valve body 1 from inside the inner cavity 10. At this time, the two-way valve guides the blood flow to flow from the near port 1a of the inner cavity 10 to the far port 1b. Through the impact of the blood flow on the second valve leaf 22 of the valve flap 2, the valve flap 2 can be kept in the closed position. When the blood flow direction changes to flow from the far port 1b of the inner cavity 10 to the near port 1a, the blood flow reversely impacts the second valve leaf 22 of the valve flap 2, giving the second valve leaf 22 a force to rotate outwardly of the inner cavity 10, causing the valve flap 2 to rotate towards the open position. During the rotation process, the first valve leaf 21 rotates inwardly of the inner cavity 10 and gradually intervenes in the blood flow, which can also play a role in blocking the flow, and can further drive the valve flap 2 to rotate faster until it reaches the open position.

[0078] Thus, for the two-way valve of this embodiment, when the blood flow direction changes, the blood flow impacts the first valve leaf 21 and the second valve leaf 22 of the valve flap 2, driving the valve flap 2 to rotate, so that the valve flap 2 automatically rotates and switches between the closed position and the open position in cooperation with the change of the blood flow direction, and timely and reliable switching response can be achieved. At the same time, by the valve flap 2 closing the open window 1c on the valve body 1 in the closed position and blocking the near port 1a and the far port 1b of the inner cavity 10 in the open position, and keeping the valve flap 2 in the closed position or the open position by the impact of the blood flow, a reliable and stable sealing effect can be achieved. Therefore, the two-way valve of this embodiment can achieve stable opening and closing, better switching response and sealing effect, and has better blood flow guiding ability.

[0079] The two-way valve of this embodiment can be used in an implantable ventricular assist device. When in use, the two-way valve is installed on an interventional catheter and placed in the aorta. The near port 1a of the inner cavity 10 of the valve body 1 is connected to the left ventricle through a section of interventional catheter, and the far port 1b of the inner cavity 10 of the valve body 1 is connected to the ventricular assist pump through another section of interventional catheter. The opening window 1c on the valve body 1 faces the aorta. When the ventricular assist pump pumps out blood, the blood in the left ventricle flows from the near port 1a of the inner cavity 10 of the valve body 1 to the far port 1b, causing the valve flap 2 to rotate to and remain in the closed position. The two-way valve guides the blood flow to flow from the left ventricle through the near port 1a and the far 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 far port 1b of the inner cavity 10 of the valve body 1 to the near port 1a, causing the valve flap 2 to rotate to and remain in the open position. The two-way valve guides the blood flow to spray from the ventricular assist pump through the far port 1b of the inner cavity 10 of the valve body 1 and the opening window 1c of the valve body 1 into the aorta, thereby realizing blood circulation assistance.

[0080] See Figures 3 to 6 , in this embodiment, preferably, both the first valve leaf 21 and the second valve leaf 22 are arc-shaped sheet structures. In the closed position, the first valve leaf 21 protrudes toward the outside of the opening window 1c, so the first valve leaf 21 has a first arc convex surface 211 facing the outside of the opening window 1c and a first arc concave surface 212 facing the inside of the inner cavity 10 of the valve body 1; the second valve leaf 22 protrudes toward the near port 1a of the inner cavity 10 of the valve body 1, so the second valve leaf 22 has a second arc convex surface 221 facing the near port 1a of the inner cavity 10 and a second arc concave surface 222 facing the far port 1b of the inner cavity 10. The first valve leaf 21 and the second valve leaf 22 are smoothly transitioned. The first arc convex surface 211 of the first valve leaf 21 and the second arc convex surface 221 of the second valve leaf 22 are smoothly transitionally connected. The first arc concave surface 212 of the first valve leaf 21 and the second arc concave surface 222 of the second valve leaf 22 are smoothly transitionally connected. Thus, the blood flow can be relatively gentle during each flushing, and at the same time, the generation of thrombus in the narrow space can be reduced.

[0081] See Figure 9 , in the open position, the first arc convex surface 211 of the first valve leaf 21 serves as a flow blocking surface. Impacted by the blood flow flowing in from the far port 1b of the inner cavity 10, the valve flap 2 is kept in the open position and guides the blood flow to flow from the far port 1b of the inner cavity 10 to the opening window 1c. When the blood flow direction changes to flow from the near port 1a of the inner cavity 10 to the far port 1b, the first arc concave surface 212 of the first valve leaf 21 serves as a flow blocking surface. Impacted by the blood flow, the valve flap 2 is driven to rotate toward the closed position. During the rotation process, the second valve leaf 22 gradually intervenes in the blood flow and the second arc convex surface 221 of the second valve leaf 22 plays a flow blocking role until the valve flap 2 rotates to the closed position.

[0082] See Figure 13, in the closed position, the second arc-shaped convex surface 221 of the second valve flap 22 serves as a flow-blocking surface, and is impacted by the blood flow flowing from the near port 1a to the far port 1b in the inner cavity 10 of the valve body 1, keeping the valve flap 2 in the closed position. When the blood flow direction changes to flow from the far port 1b to the near port 1a in the inner cavity 10, the second arc-shaped concave surface 222 of the second valve flap 22 serves as a flow-blocking surface, and is impacted by the blood flow, driving the valve flap 2 to rotate towards the open position. During the rotation process, the first valve flap 21 gradually intervenes in the blood flow, and the first arc-shaped convex surface 211 of the first valve flap 21 plays a role in blocking the blood flow until the valve flap 2 rotates to the open position.

[0083] Both the first valve flap 21 and the second valve flap 22 adopt an arc-shaped sheet structure, so that the surface blocking 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 shunting, minimizing the damage and influence on the blood flow to the greatest extent, being able to simplify the flow channel on the premise of meeting the function, being more in line with hemodynamics, and reducing the risk of thrombus formation.

[0084] See Figures 3 to 6 , for the valve flap 2 of this embodiment, its arc-shaped sheet-like first valve flap 21 has a first side edge 21a far from the second valve flap 22, and the arc-shaped sheet-like second valve flap 22 has a second side edge 22a far from the first valve flap 21.

[0085] See Figure 9 and Figure 10 , when the valve flap 2 is in the open position, the first side edge 21a of the first valve flap 21 is tangent to the inner wall of the inner cavity 10 of the valve body 1 at the lower part far from the open window 1c, and the second side edge 22a of the second valve flap 22 is in contact with the inner wall of the inner cavity 10 at the upper part close to the open window 1c and closes one end of the open window 1c close to the near port 1a of the inner cavity 10, so that both the first side edge 21a of the first valve flap 21 and the second side edge 22a of the second valve flap 22 are just obliquely cut and in contact with the inner wall of the inner cavity 10. Thus, the first valve flap 21 and the second valve flap 22 of the valve flap 2 jointly cut off the near port 1a and the far port 1b of the inner cavity 10, which can ensure the blocking effect, is beneficial to the blood ejected from the ventricular assist pump when reinjecting blood to be sprayed into the aorta, preventing the blood from flowing back into the left ventricle and avoiding additional load on the heart.

[0086] See Figure 9 , in this embodiment, preferably, when the valve flap 2 is in the open position, the second valve flap 22 is located at one end of the open window 1c close to the near port 1a of the inner cavity 10 and occupies part of the space of the open window 1c, and one end of the open window 1c close to the far port 1b of the inner cavity 10 is communicated with the far port 1b of the inner cavity 10 for the blood flow to spray out of the open window 1c. In a preferred embodiment, as Figure 9As shown, the second side edge 22a of the second valve leaf 22 just fits and contacts the inner side of one end of the opening window 1c close to the near port 1a of the inner cavity 10 of the valve body 1, so as to seal one end of the opening window 1c close to the near port 1a of the inner cavity 10 and ensure the sealing effect, preventing blood from re-entering the inner cavity 10 of the valve body 1 from one end of the opening window 1c close to the near port 1a of the inner cavity 10 when the blood is ejected from the opening window 1c, that is, preventing blood from flowing back into the left ventricle from the opening window 1c when reinjecting blood. In other embodiments, one side of the second valve leaf 22 away from the first valve leaf 21 may have an overlapping length with the wall of the inner cavity 10 of the valve body 1 along the axial direction. This overlapping length enables the second valve leaf 22 to abut against the wall of the inner cavity 10 when rotating outward to the outside of the inner cavity 10, thereby positioning the second valve leaf 22 in the open position, and one side of the second valve leaf 22 away from the first valve leaf 21 seals one end of the opening window 1c close to the near port 1a of the inner cavity 10 and ensures the sealing effect.

[0087] See Figure 13 and Figure 14 , when the valve flap 2 is in the closed position, one side of the first valve leaf 21 close to the second valve leaf 22 is located inside one end of the opening window 1c close to the near port 1a of the inner cavity 10, and one side of the first valve leaf 21 away from the second valve leaf 22 is located inside one end of the opening window 1c close to the far port 1b of the inner cavity 10 and seals one end of the opening window 1c close to the far port 1b. Thus, the first valve leaf 21 of the valve flap 2 seals the opening window 1c, which can ensure the sealing effect, is beneficial to the blood in the left ventricle flowing into the ventricular assist pump when pumping out blood, and prevents blood from being ejected into the aorta.

[0088] See Figure 13 , in this embodiment, when the valve flap 2 is in the closed position, preferably there is a spaced space between one side of the first valve leaf 21 close to the second valve leaf 22 and one end side of the opening window 1c close to the near port 1a of the inner cavity 10, which is beneficial to the valve flap 2 rotating and switching positions, and enables the connecting part of the first valve leaf 21 and the second valve leaf 22 not to exceed the outer contour of the valve body 1 during the rotation process, so as to avoid damaging the inner wall of the blood vessel during the rotation of the valve flap 2. There is a very small blood leakage amount at this spaced space, which does not affect the blood in the left ventricle flowing into the ventricular assist pump when pumping out blood.

[0089] See Figure 14, in this embodiment, when the first side edge 21a of the first valve leaf 21 and the second side edge 22a of the second valve leaf 22, which are tangent to the inner cavity wall 10 at the open position of the valve flap 2, rotate to the closed position of the valve flap 2, there are gaps between them and the inner cavity wall 10, which is conducive to the smooth rotation of the valve flap 2 in 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 21a of the first valve leaf 21 and the inner cavity wall 10 does not affect the closing of the opening window 1c by the first valve leaf 21, and there is a very small proportion of blood leakage at the gap between the second side edge 22a of the second valve leaf 22 and the inner cavity wall 10, which does not affect the inflow of blood in the left ventricle into the ventricular assist pump when pumping blood.

[0090] In this embodiment, the cross-sectional shape of the inner cavity wall 10 of the valve body 1 is preferably circular, then the contour of the first side edge 21a of the first valve leaf 21 and the contour of the second side edge 22a of the second valve leaf 22 are both ellipses that can be obliquely cut and fitted with the inner cavity wall 10.

[0091] See Figure 9 , in this embodiment, preferably, the included angle between the first valve leaf 21 and the second valve leaf 22 of the valve flap 2 is β, and this included angle β is the included angle between the first arc convex surface 211 of the first valve leaf 21 and the second arc convex surface 221 of the second valve leaf 22, and also the included angle between the first arc concave surface 212 of the first valve leaf 21 and the second arc concave surface 222 of the second valve leaf 22. The value of the included angle β is preferably 100° - 160°, which is more conducive to relatively gentle blood flow scouring each time and reducing the generation of thrombus in the narrow space.

[0092] In this embodiment, to better match the opening window 1c of the valve body 1 with the arc-shaped first valve leaf 21 and the second valve leaf 22 of the valve flap 2, see Figure 1 and Figure 2, preferably, the opening window 1c of the valve body 1 includes a first inclined cutting opening surface 1c1, a flat cutting opening surface 1c2, and a second inclined cutting opening surface 1c3 that are successively connected and formed by continuous cutting on the valve body 1. The first inclined cutting opening surface 1c1 and the second inclined cutting opening surface 1c3 form an angle or are parallel to each other. The first inclined cutting opening surface 1c1 is close to the near port 1a of the inner cavity 10 of the valve body 1, and the second inclined cutting opening surface 1c3 is close to the far port 1b of the inner cavity 10 of the valve body 1. There are two flat cutting opening surfaces 1c2 formed between the first inclined cutting opening surface 1c1 and the second inclined cutting opening surface 1c3. The first inclined cutting opening surface 1c1, the two flat cutting opening surfaces 1c2, and the second inclined cutting opening surface 1c3 are connected to form a closed ring. The two flat cutting opening surfaces 1c2 are both parallel to the axis of the valve body 1, and the two flat cutting opening surfaces 1c2 are symmetric about a symmetry center line. When the valve flap 2 is in the open position, the second side edge 22a of the second valve leaf 22 is in contact with the inner wall of the inner cavity 10 on the inner side of the first inclined cutting opening surface 1c1 of the opening window 1c, which can ensure the closing effect. 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 inside the second inclined cutting opening surface 1c3 of the opening window 1c and closes one end of the opening window 1c close to the far port 1b. The arc-shaped first valve leaf 21 can form a relatively complete inner cavity 10 cavity with the valve body 1 at the opening window 1c, improving the blood discharge volume when pumping out blood.

[0093] In this embodiment, referring to Figure 3 , connection parts 21b are respectively provided at both ends of the first valve leaf 21. The two ends of the first valve leaf 21 refer to the two ends of the profile line (arc) of the arc-shaped first valve leaf 21. The first side edge 21a of the first valve leaf 21 and the second side edge 22a of the second valve leaf 22 are connected through the edges of the two connection parts 21b to form a closed edge profile. Referring to Figure 8 and Figure 9 , the two connection parts 21b of the first valve leaf 21 are respectively rotationally connected to the valve body 1 through a pin shaft 3. The axis of the pin shaft 3 is perpendicular to the axis of the valve body 1 and the plane where the symmetry center line of the two flat cutting opening surfaces 1c2 is located. In a preferred embodiment, the axis of the pin shaft 3 is offset to the side of the valve body 1 away from the opening window 1c. The pin shaft 3 is eccentrically arranged with respect to the axis of the valve body 1 on the side of the valve body 1 away from the opening window 1c, which can facilitate the valve flap 2 to rotate and switch positions better under the impact of blood flow. In particular, it can increase the blood flow impact torque received by 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, which is beneficial for the valve flap 2 to quickly rotate to the closed position and stably maintain in the closed position. Referring to Figure 9 , the distance between the axis of the pin shaft 3 and the axis of the valve body 1 on the side of the valve body 1 away from the opening window 1c is e. The value of the distance e is preferably 0.1 mm - 1 mm. In other embodiments, the axis of the pin shaft 3 can also intersect with the axis of the valve body 1, that is, the value of the distance e is zero.

[0094] See Figure 8 and Figure 12 , there is a gap 4 between the two connecting parts 21b of the first valve leaf 21 and the cavity wall of the inner cavity 10 of the valve body 1. This gap 4 exists both when the valve flap 2 is in the open position and the closed position. This gap 4 can prevent the formation of thrombus in the stagnant area where blood is prone to coagulation between the valve flap 2 and the cavity wall of the inner cavity 10 of the valve body 1. At the same time, when the valve flap 2 is in the open position, the blood flow can pass through the gap 4 to wash the stagnant area where blood is prone to coagulation again, further reducing the formation of thrombus. When the valve flap 2 is in the open position, there is a very small proportion of blood leakage at the gap 4, which does not affect the inflow of blood in the ventricular assist pump into the opening window 1c and being ejected into the aorta when reinjecting blood.

[0095] In this embodiment, to prevent the first valve leaf 21 of the valve flap 2 from rotating from the open position to the closed position and causing damage to the inner wall of the blood vessel when the first valve leaf 21 of the valve flap 2 extends beyond the outer contour of the valve body 1, a limiting structure is provided at the opening window 1c of the valve body 1 to limit the rotation of the first valve leaf 21 of the valve flap 2 towards the outside of the inner cavity 10, that is, to define the closed position. In this embodiment, see Figure 13 , preferably, in the closed position, the side of the first valve leaf 21 away from the second valve leaf 22 abuts against the cavity wall of the inner cavity 10. Specifically, the side of the first arc convex surface 211 of the first valve leaf 21 close to the first side edge 21a abuts against the cavity wall of the inner cavity 10 on the inner side of the second oblique cutting surface 1c3 of the opening window 1c, so as to prevent the first valve leaf 21 from continuing to rotate towards the outside of the inner cavity 10 after the valve flap 2 rotates to the closed position, keep the valve flap 2 positioned with the valve body 1 in the closed position, and be located inside the inner cavity 10 of the valve body 1 without extending beyond the outer contour of the valve body 1. Thus, both the closed position of the valve flap 2 can be defined, and the side of the first valve leaf 21 away from the second valve leaf 22 can abut against the cavity wall of the inner cavity 10 to achieve that the side of the first valve leaf 21 away from the second valve leaf 22 closes the end of the opening window 1c close to the far port 1b, that is, the first valve leaf 21 closes the opening window 1c when the valve flap 2 is in the closed position.

[0096] See Figure 15 and Figure 16 , in this embodiment, when the valve flap 2 rotates to the position where the first valve leaf 21 is parallel to the axis of the valve body 1, the first valve leaf 21 is close to the closed position. At this time, there is an overlapping length X along the axial direction between the side of the first valve leaf 21 away from the second valve leaf 22 and the cavity wall of the inner cavity 10 of the valve body 1. This overlapping length X can enable the first valve leaf 21 to abut against the cavity wall of the inner cavity 10 when rotating towards the outside of the inner cavity 10, thereby limiting the first valve leaf 21 in the closed position.

[0097] Combined with Figure 15 and Figure 9, in this embodiment, the rotation angle of the first valve leaf 21 of the valve flap 2 from the position parallel to the axis of the valve body 1 to the open position is α. The first valve leaf 21 of the valve flap 2 rotates an angle α from the position parallel to the axis of the valve body 1 towards the inner side of the inner cavity 10 of the valve body 1 to reach the open position. The inclination angle of the first valve leaf 21 relative to the wall of the inner cavity 10 of the valve body 1 in the open position is α. This angle α ranges from 20° to 60°, which is beneficial for the blood flow to gently pass through the first arc-shaped convex surface 211 of the first valve leaf 21 of the valve flap 2 and spray from the opening window 1c of the valve body 1 into the aorta when the valve flap 2 is in the open position, ensuring the fluidity of the blood flow in the channel from the far port 1b to the opening window 1c of the inner cavity 10 of the valve body 1.

[0098] In this embodiment, preferably, the first valve leaf 21 and the second valve leaf 22 of the valve flap 2 are integrally formed as one piece.

[0099] See Figure 15 , in this embodiment, preferably, the valve body 1 has a middle section 11, and the opening window 1c is provided in the middle section 11. The outer peripheral contour of the middle section 11 is in an arc shape with a maximum diameter distance of D. Preferably, the cross-sectional shapes of the inner peripheral contour and the outer peripheral contour of the middle section 11 are both circular, that is, the middle section 11 is a hollow cylindrical shape. Both 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 one piece. The proximal section 12 and the distal section 13 are respectively used to connect the interventional catheter. The inner peripheral contours and the outer peripheral contours of the proximal section 12 and the distal section 13 are both circular to facilitate the assembly with the interventional catheter. The outer peripheral contour of the middle section 11 protrudes from the outer peripheral contours of the proximal section 12 and the distal section 13, thus forming steps between the proximal section 12 and the distal section 13. When the outer peripheral contour of the middle section 11 is circular, the maximum diameter distance of the outer peripheral contour of the middle section 11 is the diameter of the circular outer peripheral contour, which is D. The diameter D is adapted to the outer diameter of the interventional catheter, preferably 10Fr - 24Fr, and optimally 14Fr - 21Fr. The diameters of the outer peripheral contours of the proximal section 12 and the distal section 13 are the same, both being d. The value of the diameter d is preferably 0.7D - 0.95D, which can facilitate the bonding of the valve body 1 with the interventional catheter through the proximal section 12 and the distal section 13. The diameters of the inner peripheral contours of the proximal section 12, the middle section 11, and the distal section 13 are the same and jointly form the wall of the inner cavity 10 of the valve body 1. In this embodiment, preferably, the size of the gap 4 between the two connecting parts 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 to ensure that the proportion of the blood leakage amount at the gap 4 is very small. As Figure 15 shown, when the valve flap 2 is in the position where the first valve leaf 21 is parallel to the axis of the valve body 1, the maximum length of the valve flap 2 extending along the axial direction of the valve body 1 is N. The value of the length N is preferably 0.8D - 1.5D; the maximum height of the valve flap 2 extending along the radial direction of the valve body 1 is M. The value of the height M is preferably 0.8D - 1.5D.

[0100] See Figure 2 , in this embodiment, the included angle δ between the first beveled cutting window surface 1c1 of the window 1c on the valve body 1 and the vertical plane perpendicular to the axis of the valve body 1 should not be too large, so that when the valve flap 2 is in the open position, the second side edge 22a of the second valve leaf 22 is in contact with the inner cavity wall of the inner side of the first beveled cutting window surface 1c1 of the window 1c, and at the same time, the height M of the valve flap can be limited to avoid excessive blood flow resistance of the second valve leaf 22 when the valve flap 2 is in the closed position. Therefore, the included angle δ is preferably 0 - 45°. The included angle ε between the second beveled cutting window surface 1c3 of the window 1c on the valve body 1 and the vertical plane perpendicular to the axis of the valve body 1 is preferably 0 - 80°. The length P of the flat cutting window surface 1c2 of the window 1c on the valve body 1 extending along the axial direction of the valve body 1 is preferably 0.5D - 1.5D. The length P, the included angle δ, and the included angle ε together determine the size of the window 1c on the valve body 1, and the size of the window 1c on the valve body 1 determines the amount of blood discharged each time. The maximum length O of the window 1c on the valve body 1 extending along the axial direction of the valve body 1 is preferably 0.8D - 2D, and the ratio of the length P to the length O is preferably 1 / 4 - 1.

[0101] Of course, the above-mentioned dimensional parameters of the two-way valve in this embodiment are not limited and can be further adjusted and optimized according to the actual use situation.

[0102] Based on the two-way valve of the present invention, the present invention also provides a pulsatile interventional ventricular assist device. As Figure 17 shown, it is an embodiment of the pulsatile interventional ventricular assist device provided by the present invention. The pulsatile interventional ventricular assist device of this embodiment adopts the above-mentioned two-way valve of this embodiment. Since this two-way valve can achieve stable opening and closing, better switching response and sealing effect, and has better blood flow guiding ability, the working ability and operation effect of the pulsatile interventional ventricular assist device of this embodiment have been effectively improved and optimized.

[0103] Specifically, the pulsatile interventional ventricular assist device of this 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 extraction and reinfusion of blood by the pump 400, which are connected in sequence. The two-way valve 200 adopts the two-way valve of the present invention and can be the two-way valve described above in this embodiment. The ventricular catheter 100 is delivered to the left ventricle of the heart 600 through the femoral artery 500. One end of the ventricular catheter 100 communicates with the left ventricle, and the other end of the ventricular catheter 100 is preferably connected to the proximal portion 12 of the two-way valve 200 by bonding or injection molding, so as to communicate with the near 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 is the same as that of the ventricular catheter 100. One end of the peripheral catheter 300 is preferably connected to the distal portion 13 of the two-way valve 200 by bonding or injection molding, so as to communicate with the far port 1b of the inner cavity 10 of the valve body 1, and the other end of the peripheral catheter 300 is preferably connected to the pump 400 by bonding. The pump 400 is preferably a diaphragm pump, which extracts and reinfuses blood at a set pulsatile frequency under the control and drive of the external control device. The diaphragm pump and its external control device can both adopt existing devices and will not be elaborated herein.

[0104] The working principle of the pulsatile interventional ventricular assist device of this embodiment is that the external control device provides a set pulse to the pump 400, so that the blood flow direction changes during the process of the pump 400 extracting and reinfusing blood. The pulsation set by the external control device synchronously "pushes and pulls" the pump 400 with the heart 600 to achieve blood extraction and reinfusion. During the myocardial contraction period, the blood flow enters the two-way valve 200 through the tip of the ventricular catheter 100 located in the left ventricle. The blood flow flows from the near port 1a of the inner cavity 10 of the valve body 1 to the far port 1b. The blood flow impacts the first arc-shaped concave surface 212 of the first valve leaf 21 and the second arc-shaped convex surface 221 of the second valve leaf 22 of the valve flap 2, driving the first valve leaf 21 of the valve flap 2 to rotate around the pin shaft 3 to the outside of the inner cavity 10 of the valve body 1 to the closed position, closing the opening window 1c of the valve body 1. The blood flow flows from the near port 1a of the inner cavity 10 of the valve body 1 to the far port 1b and is sucked into the pump 400 through the peripheral catheter 300. The external control device sets a pulse for the pump 400, so that the blood flow in the pump 400 is reinfused into the peripheral catheter 300 and enters the two-way valve 200. When the blood just enters the far 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 flow reversely flows into the inner cavity 10 of the valve body 1, it impacts the second arc-shaped concave surface 222 of the second valve leaf 22 and the first arc-shaped convex surface 211 of the first valve leaf 21 of the valve flap 2, driving the first valve leaf 21 of the valve flap 2 to rotate around the pin shaft 3 to 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 laterally ejected from the opening window 1c of the valve body 1 into the aorta 700 to complete a cycle.

[0105] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the technical principle of the present invention, several improvements and substitutions can be made, and these improvements and substitutions should also be regarded as the protection scope 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) and a second valve leaf (22) connected at an obtuse angle, the first valve leaf (21) being disposed at the opening window (1c), the second valve leaf (22) being disposed at an end of the first valve leaf (21) close to the proximal port (1a) and located at 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 first valve leaf (21) and the second valve leaf (22) 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, wherein 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) protrudes toward the outer side of the opening window (1c), and the second valve leaf (22) protrudes toward the proximal port (1a). There is a smooth transition between the first valve leaf (21) and the second valve leaf (22).

3. The two-way valve according to claim 2, characterized in that, In the open position, the first side edge (21a) of the first valve leaf (21) away from the second valve leaf (22) is tangent to the wall of the inner cavity (10), and the second side edge (22a) of the second valve leaf (22) away from the first valve leaf (21) 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, wherein The window (1c) comprises a first oblique cut window surface (1c1), a flat cut window surface (1c2) and a second oblique cut window surface (1c3) which 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; two flat cut window surfaces (1c2) are formed; both of the two flat cut window surfaces (1c2) are parallel to the axis of the valve body (1) and symmetrical about a symmetry center line.

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

6. The two-way valve according to claim 5, characterized in that, There is a gap (4) between the connecting part (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 (1c) is provided in 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 4, characterized in that, The included angle between the first inclined cut window (1c1) and the vertical plane perpendicular to the axis of the valve body (1) is 0 - 45°. The included angle between the second inclined cut window (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 (1c) is provided in 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 P of the flat cut window (1c2) extending along the axial direction of the valve body (1) ranges from 0.5D to 1.5D. The maximum length O of the opening (1c) extending along the axial direction of the valve body (1) ranges from 0.8D to 2D. The ratio of the length P to the length O is 1 / 4 - 1.

9. 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).

10. 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°.

11. The two-way valve according to any one of claims 1 to 6, characterized in that, The rotation angle of the first valve leaf (21) from the position parallel to the axis of the valve body (1) to the open position is 20° - 60°.

12. A pulsatile percutaneous ventricular assist device, characterized in that, Adopt the two-way valve according to any one of claims 1 to 11.

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