Bidirectional valve and ventricular assist intervention device

Abstract

The application relates to the technical field of medical devices, and provides a bidirectional valve and a ventricular assist intervention device. The bidirectional valve comprises a valve body, the valve body is a tubular structure with a proximal end and a distal end, a first window is formed in the side wall of the valve body, and the inner side wall of the area close to the distal end of the first window is provided with a thickened part; a valve clack is rotatably arranged in the valve body, and the valve clack can rotate between a first state position and a second state position; in the first state position, the valve clack closes the proximal end of the valve body, and the distal end is in communication with the first window; in the second state position, the valve clack closes the first window, and the valve clack abuts against the thickened part, and the proximal end is in communication with the distal end. According to the technical scheme, when the valve clack rotates to the second state position, the blood flow unstable area close to the first window area on the inner side of the main catheter can be avoided, so that the stability of the valve clack is improved, the shear stress of the bidirectional valve on the blood cells in the blood is optimized, hemolysis is reduced, and the influence on the assist intervention is small.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a bidirectional valve and a ventricular assist intervention device. BACKGROUND

[0002] At present, in the medical field, the ventricular assist intervention device is a commonly used auxiliary device for Percutaneous Coronary Intervention (PCI), such as a Percutaneous Ventricular Assist Device (pVAD), which is inserted into the body (femoral artery, etc.) through the skin (percutaneously), and then connected to the heart to help or take over the blood pumping function of the heart, increase blood flow, enhance blood perfusion, reduce myocardial oxygen consumption, and can help acute heart failure patients enhance the heart pumping function in the short term. In the above device, the bidirectional valve on the in-vivo catheter located in the external aorta is a key structure for the whole device to deliver blood. The existing bidirectional valve of the ventricular assist intervention device usually sets a rotatable valve flap structure at the opening of the valve body. When the heart contracts, blood enters the catheter through the front end of the catheter extending into the heart and is pumped outwards through the bidirectional valve. At this time, the valve flap is pushed by the blood and closes the valve body opening. When the heart relaxes, the blood is pumped back to the heart by the extracorporeal pump. At this time, the valve flap of the bidirectional valve opens the valve body window and can guide the blood to flow into the ascending aorta through the valve body window, thereby generating additional blood flow. However, the existing bidirectional valve has some drawbacks in structural design. When the blood flows out, the valve flap rotates to close the valve body window, and the valve flap and the unstable area near the valve body window cause the valve flap to shake and be unstable under the impact of the blood flow, thereby adversely affecting the auxiliary treatment. SUMMARY

[0003] In order to solve the problem of instability of the valve flap of the bidirectional valve of the ventricular assist intervention device in the blood flow process and the adverse effect on the auxiliary intervention, the present application provides a bidirectional valve and a ventricular assist intervention device.

[0004] In the embodiment of the first aspect of the application, a bidirectional valve is provided, comprising: a valve body, the valve body being a tubular structure, and the valve body having a proximal end and a distal end arranged oppositely, a first window being formed on one side wall of the valve body in a first direction perpendicular to the axial direction of the valve body, and the inner side wall of the region of the first window close to the distal end having a thickened portion protruding towards the inside of the valve body; a valve disc rotatably arranged in the valve body and corresponding to the first window, the shape of the valve disc being adapted to the first window, and the valve disc being rotatable between a first state position and a second state position relative to the valve body; wherein, in the first state position, the valve disc closes the proximal end of the valve body, and the distal end is in communication with the first window; in the second state position, the valve disc closes the first window, and the valve disc abuts against the thickened portion, and the proximal end is in communication with the distal end.

[0005] In further embodiments of the application, the valve disc comprises a first arc segment and a second arc segment connected to each other, the first arc segment being close to the proximal end relative to the rotation axis of the valve disc, and the second arc segment being close to the distal end relative to the rotation axis; wherein, in a plane perpendicular to the rotation axis, the first arc segment and the second arc segment form a first included angle, the first included angle being on the side of the valve disc away from the first window, and the first included angle being in the angle range of (90°, 180°].

[0006] In further embodiments of the application, the second direction is perpendicular to the first direction and perpendicular to the axial direction of the valve body, the inner side walls of both sides of the valve body in the second direction have first connecting structures, and in the first direction, the first connecting structures are arranged opposite to the edge of the first window close to the proximal end; the valve disc is a one-piece structure, and the two sides of the valve disc in the second direction have second connecting structures respectively, and the second connecting structures are rotatably connected with the corresponding first connecting structures; wherein, one of the first connecting structure and the second connecting structure is a connecting column, and the other is a connecting hole or a connecting groove.

[0007] In further embodiments of the application, in the plane perpendicular to the rotation axis, the length of the second arc segment is greater than the length of the first arc segment; wherein, in the first direction, the rotation axis corresponds to one end of the first window close to the proximal end.

[0008] In further embodiments of the application, in the first state position, the region of the first arc segment away from the second arc segment abuts against the edge of the first window close to the proximal end, the second arc segment abuts against the inner side wall of the valve body away from the first window in the first direction, and the valve disc closes the proximal end in the axial direction of the valve body; in the second state position, the region of the first arc segment close to the second arc segment abuts against the edge of the first window close to the proximal end, the second arc segment abuts against the inner side of the thickened portion, and the valve disc closes the first window.

[0009] In a further embodiment of the present application, the end of the second arc segment away from the first arc segment has a chamfer structure, and the chamfer structure forms a second included angle with the side of the second arc segment away from the first window; wherein the angle of the second included angle ranges from 120° to 155°; and / or the length of the chamfer structure ranges from 0.5 mm to 1.8 mm.

[0010] In a further embodiment of the present application, the inner side of the thickened portion is an arc-shaped surface that is adapted to the valve disc, and the thickened portion can form a surface contact with the valve disc.

[0011] In a further embodiment of the present application, the inner side of the thickened portion has a flexible buffer layer that can abut against the valve disc.

[0012] In a further embodiment of the present application, in the first direction, the maximum distance by which the thickened portion protrudes towards the inner side of the valve body ranges from 0.3 mm to 1 mm; and / or the maximum thickness of the valve disc ranges from 0.1 mm to 0.3 mm.

[0013] In a further embodiment of the present application, the portion of the valve body between the proximal end and the distal end is a middle portion of the valve body, and the thickness of the middle portion of the valve body is greater than the thickness of the proximal end and the thickness of the distal end; wherein the thickness of the proximal end and the thickness of the distal end each ranges from 0.1 mm to 0.28 mm, and the thickness of the middle portion of the valve body ranges from 0.1 mm to 0.3 mm.

[0014] In an embodiment of the second aspect of the technical solution of the present application, a ventricular assist intervention device is also provided, comprising: a catheter assembly, the catheter assembly comprising a catheter front end, a bidirectional valve according to any of the above embodiments, and a main catheter connected in sequence; a diaphragm pump, one end of the diaphragm pump being connected to an end of the main catheter away from the bidirectional valve; and a host device, the host device being connected to an end of the diaphragm pump away from the main catheter, and the host device being configured to drive the diaphragm pump to pump blood into the bidirectional valve.

[0015] The beneficial effects of the above technical solutions of the present application are as follows:

[0016] According to the bidirectional valve in the present application, through the improvement and optimization of the structure, when the blood flows from the proximal end to the distal end of the valve body, the valve disc rotates to the second state position and abuts against the thickened portion on the inner side of the edge of the first window, which can avoid the unstable blood flow area near the inner side of the main catheter in the region of the first window, so that the valve disc can maintain a stable state, the first window always remains closed, and the shear stress of the bidirectional valve on the blood cells in the blood is optimized, which is beneficial to reducing hemolysis and reducing the adverse effects on the assist intervention effect. BRIEF DESCRIPTION OF DRAWINGS

[0017] Figure 1 is a top view of the bidirectional valve in an embodiment of the present application (the valve disc is in the first state position);

[0018] Figure 2 perspective view of a bidirectional valve according to an embodiment of the present application (the valve flap is in the first state position);

[0019] Figure 3 cross-sectional view of a bidirectional valve according to an embodiment of the present application (the valve flap is in the first state position);

[0020] Figure 4 left view of a bidirectional valve according to an embodiment of the present application;

[0021] Figure 5 right view of a bidirectional valve according to an embodiment of the present application;

[0022] Figure 6 schematic view of a ventricular assist intervention device according to an embodiment of the present application;

[0023] Figure 7 schematic view of the in-vivo portion of the catheter assembly of a ventricular assist intervention device according to an embodiment of the present application (wherein the right side of the figure is a partial area view of the bidirectional valve);

[0024] Figure 8 top view of a bidirectional valve according to an embodiment of the present application (the valve flap is in the second state position);

[0025] Figure 9 perspective view of a bidirectional valve according to an embodiment of the present application (the valve flap is in the second state position);

[0026] Figure 10 cross-sectional view of a bidirectional valve according to an embodiment of the present application (the valve flap is in the second state position);

[0027] Figure 11 left view of a bidirectional valve according to another embodiment of the present application;

[0028] Figure 12 right view of a bidirectional valve according to another embodiment of the present application;

[0029] Figure 13 cross-sectional view of a bidirectional valve according to another embodiment of the present application (the valve flap is in the first state position);

[0030] Figure 14 cross-sectional view of a bidirectional valve according to another embodiment of the present application (the valve flap is in the second state position).

[0031] In the above figures, arrow F1 represents the first direction, arrow F2 represents the second direction, and arrow F3 represents the axial direction of the valve body;

[0032] In the above Figure 3 and Figure 10In the figure, the dotted arrow indicates the direction of blood flow.

[0033] Reference signs:

[0034] 100 bidirectional valve, 1 valve body, 10 middle part of valve body, 11 proximal end, 12 distal end, 13 first window, 14 thickened part, 16 connecting column, 2 valve flap, 21 first arc segment, 22 second arc segment, 23 connecting hole, 24 chamfer structure;

[0035] 300 ventricular assist intervention device, 310 catheter assembly, 311 catheter front end, 312 main catheter, 313 second window, 320 diaphragm pump, 330 main device;

[0036] 410 heart, 420 ascending aorta, 421 aortic arch; a first included angle, b second included angle. DETAILED DESCRIPTION

[0037] The application will be further described below in detail with specific embodiments and the accompanying drawings. In different embodiments, similar elements are associated with similar element reference numbers. In the following embodiments, many details are described in order to make the application better understood. However, those skilled in the art can easily recognize that some features can be omitted in different cases, or can be replaced by other elements, materials, methods. In some cases, some operations related to the application are not shown or described in the specification, in order to avoid the core part of the application being overwhelmed by too much description, and it is not necessary to describe these related operations in detail for those skilled in the art according to the description in the specification and general technical knowledge in the art.

[0038] In addition, the features, operations or characteristics described in the specification can be combined in any appropriate way to form various embodiments, and the operation steps involved in each embodiment can also be sequentially adjusted or adjusted in a manner that is obvious to those skilled in the art. Therefore, the specification and drawings are only for the purpose of clearly describing one embodiment, and do not mean that the composition and / or order is necessary.

[0039] In this paper, the serial number of the component itself, such as "first", "second", etc., is only used to distinguish the described object, and has no technical meaning. Unless otherwise specified, "connection" and "coupling" in this application include direct and indirect connection (coupling).

[0040] The bidirectional valve provided in the application can be assembled in a catheter of a ventricular assist intervention device to generate additional blood flow during a cardiac intervention treatment, and switching between communication of a distal end of the catheter with a proximal end of the catheter or communication of the distal end of the catheter with an ascending aorta is realized by rotation of the bidirectional valve, and the switching frequency is adapted to the frequency of cardiac blood pumping, thereby realizing an auxiliary blood supply function.

[0041] Some embodiments of the bidirectional valve and the ventricular assist intervention device provided in the application are described below in combination with the accompanying drawings.

[0042] In the embodiments of the first aspect of the application, a bidirectional valve 100 is provided, as shown in Figure 1 、 Figure 2 and Figure 3 , the bidirectional valve 100 comprises a valve body 1 and a valve flap 2. The valve body 1 adopts a tubular structure, a first window 13 is formed on a side wall of the valve body 1, and the first window 13 is located on one side wall in a first direction perpendicular to the axial direction of the valve body 1; the valve flap 2 is arranged in the valve body 1 at a position corresponding to the first window 13 and is rotationally connected with the valve body 1, as shown in Figure 3 、 Figure 4 and Figure 5 , the valve flap 2 is shaped to be adapted to the first window 13, and the valve flap 2 can rotate relative to the valve body 1 to switch between a first state position and a second state position in the valve body 1, thereby opening or closing the first window 13. In the axial direction of the valve body 1, one end of the valve body 1 is a proximal end 11, and the other end of the valve body 1 is a distal end 12; when applied to a ventricular assist intervention device 300, as shown in Figure 6 and Figure 7 , the proximal end 11 of the valve body 1 is used to connect a catheter front end 311 to be able to extend into a ventricle, and the distal end 12 of the valve body 1 is used to connect a main catheter 312 to be able to connect an extracorporeal diaphragm pump 320 and a main device 330 through the main catheter 312. When the valve flap 2 rotates to the first state position, the proximal end 11 is closed, as shown in the state in Figure 3 , at this time, the distal end 12 communicates with the first window 13; when the valve flap 2 rotates to the second state position, as shown in the state in Figure 8 、 Figure 9 and Figure 10 , the first window 13 is closed by the valve flap 2, at this time, the proximal end 11 communicates with the distal end 12. As shown in Figure 3 and Figure 10 , the inner side wall of the area of the first window 13 close to the distal end 12 of the valve body 1 has a thickened portion 14, and the thickened portion 14 protrudes inwardly along the first direction to the valve body 1; when the valve flap 2 rotates to the second state position, the valve flap 2 abuts against the thickened portion 14, as shown in Figure 10The state shown in the figure is such that there is a certain gap between the valve disc 2 and the outer wall of the valve body 1, thereby avoiding contact between the valve disc 2 and the unstable area on the side wall of the valve body 1, which helps to enhance the stability of the valve disc 2 during blood flow.

[0043] When using, such as Figure 6 and Figure 7 In the example shown, the catheter tip 311 extends into the left ventricle, and the bidirectional valve 100 is located within the ascending aorta 420 (e.g., the region of the aortic arch 421 in the illustration). When the heart 410 contracts, blood flows from the ventricle into the catheter tip 311. Upon passing through the bidirectional valve 100, the valve valve 2 rotates to the second position, at which point the first window 13 is closed, and the proximal end 11 and distal end 12 of the valve body 1 communicate, allowing blood to flow through the bidirectional valve 100 and the main guide tube 312 into the external diaphragm pump 320. The blood flow direction is as follows: Figure 10 As shown by the dashed arrow, when the heart 410 relaxes, the valve disc 2 of the bidirectional valve 100 rotates to the first position. At this time, the proximal end 11 and distal end 12 of the valve body 1 are closed, while the first window 13 is opened. Blood from the diaphragm pump 320 enters the bidirectional valve 100 through the main tube 312 and flows into the ascending aorta 420 through the first window 13, thus completing one blood pumping cycle. Once the main tube 312 is filled with blood, it is connected to the diaphragm pump 320 and the main unit 330. The pumping frequency of the main unit 330 and the diaphragm pump 320 is coordinated with the heart rate to push the medium, thus forming a blood pumping operation.

[0044] It is understandable that after the bidirectional valve 100 is connected to the main tube 312, the area on the inner side of the main tube 312 near the first window 13 is prone to forming an unstable blood flow area. When the blood flows from the proximal end 11 to the distal end 12, if the valve disc 2 is close to the edge of the first window 13 and the inner side of the valve disc 2 is basically parallel to the direction of blood flow, the valve disc 2 will be too close to the unstable blood flow area on the inner edge of the first window 13. Under the impact of blood flow, the valve disc 2 is prone to shaking and affecting the working stability.

[0045] In this embodiment, the bidirectional valve 100, through structural improvements and optimizations, allows the valve disc 2 to rotate to a second state position and abut against the thickened portion 14 on the inner side of the edge of the first window 13 when blood flows from the proximal end 11 to the distal end 12 of the valve body 1. This avoids the unstable blood flow area near the first window 13 on the inner side of the main tube 312, enabling the valve disc 2 to maintain a stable state and the first window 13 to remain closed. At the same time, the bidirectional valve 100 optimizes the shear stress on blood cells in the blood, which helps reduce hemolysis and minimizes adverse effects on the interventional effect.

[0046] It should be noted that in actual applications, the shape and size of the first window 13 can be set according to the specific shape, size and application scenario of the bidirectional valve 100, for example, the first window 13 can be set to a circular, oval or other shape, and correspondingly, the valve disc 2 can adopt a shape structure that matches the first window 13 to be able to close the first window 13.

[0047] In further embodiments of the present application, as shown in Figures 1 to 3 In the bidirectional valve 100, the valve disc 2 includes a first arc segment 21 and a second arc segment 22, and the first arc segment 21 is located near the proximal end 11 of the valve body 1, and the second arc segment 22 is located near the distal end 12 of the valve body 1, that is, one end of the first arc segment 21 is near the proximal end 11 of the valve body 1, the other end of the first arc segment 21 is connected with the second arc segment 22, and the end of the second arc segment 22 away from the first arc segment 21 is near the distal end 12 of the valve body 1. In a plane perpendicular to the rotation axis of the valve disc 2, as an example in Figure 3 and Figure 10 The first arc segment 21 and the second arc segment 22 form a first included angle a, and the first included angle a is located on the side of the valve disc 2 away from the first window 13. Wherein, the first included angle a is in the angle range of (90°, 180°], that is, the angle range of the first included angle a is 90°<first included angle a≤180°, so that the second arc segment 22 of the valve disc 2 corresponds to the thickened part 14 near the distal end 12 of the first window 13, and the first arc segment 21 of the valve disc 2 corresponds to the edge near the proximal end 11 of the first window 13, so as to adapt to the first window 13, and to be able to open or close the first window 13 by switching the positions of the first arc segment 21 and the second arc segment 22 of the valve disc 2 relative to the first window 13. In particular, when the first included angle a is equal to 180°, the first arc segment 21 and the second arc segment 22 of the valve disc 2 are in a parallel state, at this time the valve disc 2 forms a one-piece structure; in actual applications, the position of the rotation axis can be adjusted adaptively, so that the valve disc can both open and close the first window 13 when the first included angle a is equal to 180°, and the first arc segment 21 can also be kept in abutment with the end of the first window 13 near the proximal end 11, to avoid the gap between the first arc segment 21 and the first window 13 causing blood outflow.

[0048] Further, as shown in Figure 3In the example, when valve disc 2 is in the first state position, the first arc segment 21 abuts against the edge of the first window 13 near the proximal end 11, and the abutment point is located in the region of the first arc segment 21 near the proximal end 11. The second arc segment 22, forming a first angle α with the first arc segment 21, abuts against the inner wall of the valve body 1 on the side away from the first window 13 in the first direction. This closes the channel between the proximal end 11 and the distal end 12 of the valve body 1 through valve disc 2, while simultaneously opening the first window 13. The distal end 12 of the valve body 1 communicates with the first window 13, allowing blood to flow from the distal end 12 of the valve body 1 and through the first window 13 towards the ascending aorta 420. When valve disc 2 is in the second state position, as... Figure 10 In the example, valve disc 2 is relative to Figure 3 The valve body 1 rotates counterclockwise by a certain angle. At this time, the first arc segment 21 is still in contact with the edge of the first window 13 near the proximal end 11, but the contact point is transferred to the area of ​​the first arc segment 21 near the second arc segment 22. The second arc segment 22 rotates to contact the thickened part 14 and blocks the first window 13 together with the first arc segment 21 and the second arc segment 22, so that the first window 13 is in a closed state. At this time, the proximal end 11 and the distal end 12 of the valve body 1 are connected, and the blood in the ventricle can flow from the proximal end 11 to the distal end 12 through the valve body 1, and then flow to the diaphragm pump 320 outside the body through the main tube 312. That is, when the valve disc 2 is in the first state position, the second state position, and in between, the first arc segment 21 always abuts against the edge of the first window 13 near the proximal end 11, only the specific position of the abutment point is different; when the valve disc 2 is in the second state position, the surface of the second arc segment 22 abuts against the thickened part 14; when the valve disc 2 is in the first state position or in between the first state position and the second state position, the second arc segment 22 separates from the thickened part 14, and the closer the valve disc 2 is to the first state position, the larger the opening of the first window 13.

[0049] Furthermore, in one embodiment, such as Figures 3 to 5 as well as Figure 11 , Figure 12 In the example, in a second direction perpendicular to the axial direction of the valve body 1 and perpendicular to the first direction, a first connecting structure is correspondingly provided on the inner sidewalls of both sides of the valve body 1, and a second connecting structure is correspondingly provided on both sides of the valve disc 2, with the first connecting structure and the second connecting structure on the corresponding side forming a rotatable connection; wherein, of the first connecting structure and the second connecting structure, one can be a connecting post, and the other can be a connecting hole or a connecting groove. For example, as shown... Figures 3 to 5In the example shown in FIG. 1 and FIG. 2, the first connecting structure on the inner side wall of the two sides of the valve body 1 is a connecting column 16, and the two connecting columns 16 are coaxially arranged; correspondingly, the second connecting structure on the two sides of the valve disc 2 is a connecting hole 23 matched with the connecting column 16, and the connecting hole 23 is rotationally connected with the corresponding connecting column 16. The valve disc 2 can rotate relative to the valve body 1 around the connecting column 16, and the two sides of the valve disc 2 can be supported by the connecting column 16, so that the force on the two sides of the valve disc 2 is relatively balanced. It should be noted that the connecting column 16 and the connecting hole 23 can be interchanged, and the connecting hole 23 can be replaced by a connecting groove. The valve disc 2 adopts an integrated structure, which can be integrally formed in the machining and manufacturing process, without the need for subsequent assembly, which is beneficial to simplify the process flow. In addition, the thickened portion 14 abuts against the second arc segment 22, which correspondingly shortens the rotation stroke of the second arc segment 22, and the force required for the rotation of the valve disc 2 is correspondingly reduced, so that the area of the first window 13 on the valve body 1 can be increased to further increase the flow of blood pumped to the heart, which is beneficial to further improve the heart pump burden of the patient.

[0050] Further, in an embodiment, as shown in Figure 3 and Figure 10 In the example shown in FIG. 1 and FIG. 2, the length of the second arc segment 22 is greater than the length of the first arc segment 21 in the plane perpendicular to the rotation axis of the valve disc 2, so that the second arc segment 22 corresponds to most of the area of the first window 13. In the first direction, the rotation axis of the valve disc 2 is arranged corresponding to one end of the first window 13 close to the proximal end 11, that is, in the axial direction of the valve body 1, the rotation axis of the valve disc 2 is closer to one end of the first window 13 towards the proximal end 11, and away from one end of the first window 13 towards the distal end 12, so as to further increase the opening of the first window 13, so as to increase the blood flow when the blood flows through the first window 13 from the distal end 12 of the valve body 1.

[0051] Further, in an embodiment, as shown in Figure 13 and Figure 14 Further, in an embodiment, as shown in Figure 13 and Figure 14 The second arc segment 22 of the valve disc 2 has a chamfer structure 24, which is located at one end of the second arc segment 22 away from the first arc segment 21, and the chamfer structure 24 is arranged inclined relative to the second arc segment 22, so that a second included angle b is formed between the chamfer structure 24 and the second arc segment 22, and the second included angle b is away from the first window 13. The angle range of the second included angle b is 120° to 155°, that is, on the side towards the first window 13, the chamfer structure 24 is arranged inclined relative to the extension line of the second arc segment 22 by 25° to 60°. When the valve disc 2 is in the first state position, the blood enters the valve body 1 from the distal end 12 of the valve body 1, and contacts the chamfer structure 24 and the second arc segment 22, and the blood flows to the first window 13 under the guidance of the chamfer structure 24 and the second arc segment 22, and flows to the ascending aorta 420 through the first window 13.

[0052] It can be understood that, since the second arc segment 22 is mainly used to abut against the thickened portion 14 to block the first window 13, for the valve disc 2 without the cut corner structure 24, when the valve disc 2 is in the first state position, the inclination of the second arc segment 22 relative to the first direction is large, and when the blood passes through the first window 13 along the surface of the second arc segment 22, the bleeding direction is towards the outside of the first window 13 close to the proximal end 11, forming an oblique bleeding; compared with the valve disc without the cut corner structure 24, when the valve disc 2 is in the first state position, the cut corner structure 24 can guide the blood to pass through the first window 13, and the flow direction of the blood is closer to the central region of the first window 13, which can reduce the impact on the ascending aorta 420, and the blood can enter the ascending aorta 420 more smoothly. In the process of switching the valve disc 2 from the first state position to the second state position, since the second arc segment 22 is provided with the cut corner structure 24, the blood flowing from the proximal end 11 to the distal end 12 forms pressure on the second arc segment 22 and the cut corner structure 24 at the same time, and since the cut corner structure 24 is inclined, the cut corner structure 24 is subjected to greater pressure of the blood, so that the rotational torque of the valve disc 2 is increased, and the valve disc 2 can rotate to the second state position more quickly, and the response speed is faster. In the process of switching the valve disc 2 from the second state position to the first state position, since the second arc segment 22 is provided with the cut corner structure 24, the blood flowing from the distal end 12 to the proximal end 11 forms pressure on the cut corner structure 24 at the same time, so that the rotational torque required by the valve disc 2 is reduced, the rotational inertia of the system is reduced correspondingly, and the response speed of the valve disc 2 when opening is faster.

[0053] Further, as examples in Figure 13 and Figure 14 The length of the cut corner structure 24 is in the range of 0.5mm to 1.8mm, so that the cut corner structure 24 can maintain sufficient action surface to guide the blood, and at the same time, the length of the cut corner structure 24 can be prevented from being too large to reduce the blood flow between the proximal end 11 and the distal end 12 when the valve disc 2 is in the second state position.

[0054] In further embodiments of the present application, as examples in Figures 8 to 12 In the first direction, the inner side of the thickened portion 14 is in an arc surface shape, and the arc surface shape is matched with the shape of the valve disc 2; when the valve disc 2 rotates to the second state position, the valve disc 2 forms a surface contact with the thickened portion 14, that is, the valve disc 2 can abut against the thickened portion 14 in the circumferential direction of the arc surface, so as to completely close the region of the first window 13 close to the distal end 12, and avoid affecting the blood pumping due to the gap.

[0055] In a further embodiment of the present application, the inner side of the thickened portion 14 is provided with a flexible buffer layer in the first direction, so that when the valve disc 2 rotates to abut against the thickened portion 14, the flexible buffer layer can buffer the valve disc 2 to reduce the impact force and prevent the valve disc 2 from being deformed. At the same time, the flexible buffer layer can also seal with the valve disc 2 to further prevent the possibility of a gap between the valve disc 2 and the thickened portion 14.

[0056] It should be noted that in actual applications, the flexible buffer layer and the thickened portion 14 can be a split structure, the flexible buffer layer is made of a flexible material, and the thickened portion is made of a hard material. The hard material can be a metal material or a hard polymer material, wherein the hard polymer material can be selected from PEEK (polyether ether ketone), PE (polyethylene), PC (polycarbonate), ABS (acrylonitrile-butadiene-styrene plastic), etc. The flexible buffer layer can be connected to the inner side of the thickened portion 14 by a corresponding connection method (such as coating, bonding, etc.). Of course, the thickened portion 14 and the flexible buffer layer can also be an integral molding structure, for example, the thickened portion 14 is made of a flexible material as a whole, wherein the flexible material can be a soft polymer material such as silicone rubber, PEBAX (block polyether amide resin), TPU (thermoplastic polyurethane rubber), etc., which can simultaneously play a buffering and sealing role. Similarly, the thickened portion 14 and the valve body 1 can also be a split structure and be connected and assembled by a corresponding connection method, or the thickened portion 14 and the valve body 1 can be an integral molding structure.

[0057] In a further embodiment of the present application, as shown in Figure 3 and Figure 10 In the valve body 1, the thickened portion 14 protrudes towards the inner side of the valve body 1 along the first direction, and the maximum protrusion distance is in the range of 0.3mm to 1mm, so that in the second state position, when the valve disc 2 abuts against the thickened portion 14, it can not only avoid the unstable area near the first window 13 edge of the main conduit 312, but also avoid the valve disc 2 being too close to the inner side of the valve body 1 to cause excessive blockage of the blood flowing from the proximal end 11 to the distal end 12, so as to prevent the blood flow from being reduced and affecting the normal pumping of the heart.

[0058] In an embodiment of the present application, as shown in Figures 1 to 5 and Figures 8 to 12In the example shown in FIG. 1, the valve body 1 specifically comprises a proximal end 11, a valve body middle part 10 and a distal end 12 connected in sequence along the axial direction; the valve body middle part 10 is located between the proximal end 11 and the distal end 12, and the first window 13 is formed on the sidewall of the valve body middle part 10. Among them, the thickness of the valve body middle part 10 is greater than the thickness of the proximal end 11, and also greater than the thickness of the distal end 12. For example, in a preferred example, the proximal end 11 and the distal end 12 of the valve body 1 are both tubular structures with a thickness in the range of 0.1mm to 0.28mm, while the valve body middle part 10 is a tubular structure with a thickness in the range of 0.1mm to 0.3mm, and the inner diameters of the proximal end 11, the valve body middle part 10 and the distal end 12 are consistent, so that the valve body 1 as a whole forms a tubular structure with relatively thin ends and a thick middle part. When the bidirectional valve 100 is applied to the ventricular assist intervention device 300, the catheter front end 311 can be sleeved outside the proximal end 11 of the valve body 1, and the main catheter 312 can be sleeved outside the distal end 12 of the valve body 1, thereby completing the assembly of the bidirectional valve 100 with the catheter front end 311 and the main catheter 312, Figure 6 The state after assembly is shown in FIG. 1, and by virtue of the feature that the thicknesses of the proximal end 11 and the distal end 12 are less than the thickness of the valve body middle part 10, the outer sidewalls of the catheter front end 311 and the main catheter 312 can be flush with the valve body middle part 10 after the bidirectional valve 100 is assembled.

[0059] In the embodiment of the second aspect of the present application, a ventricular assist intervention device 300 is provided, as shown in Figure 1 , Figure 6 The ventricular assist intervention device 300 comprises a catheter assembly 310, a diaphragm pump 320 and a main device 330. The catheter assembly 310 comprises a catheter front end 311, the bidirectional valve 100 in any of the embodiments of the first aspect described above and a main catheter 312 connected in sequence. The proximal end 11 of the bidirectional valve 100 is connected to the catheter front end 311, and the distal end 12 of the bidirectional valve 100 is connected to the main catheter 312; one end of the main catheter 312 away from the bidirectional valve 100 is connected to one end of the diaphragm pump 320, and the other end of the diaphragm pump 320 is connected to the main device 330 through a pipeline. The diaphragm pump 320 is used to store the blood pumped from the ventricle, and the main device 330 drives the blood in the diaphragm pump 320 to flow back to the catheter assembly 310 by delivering medium to the diaphragm pump 320.

[0060] In use, as shown in Figure 6 and Figure 7In the example shown, the catheter tip 311 extends into the left ventricle, and the bidirectional valve 100 is located within the ascending aorta 420 (e.g., the region of the aortic arch 421 in the illustration). When the heart 410 contracts, blood flows from the ventricle into the catheter tip 311. Upon passing through the bidirectional valve 100, the valve valve 2 rotates to the second position, at which point the first window 13 is closed, and the proximal end 11 and distal end 12 of the valve body 1 communicate, allowing blood to flow through the bidirectional valve 100 and the main guide tube 312 into the external diaphragm pump 320. The blood flow direction is as follows: Figure 10 As shown by the dashed arrow, when the heart 410 relaxes, the valve disc 2 of the bidirectional valve 100 rotates to the first position. At this time, the proximal end 11 and distal end 12 of the valve body 1 are closed, while the first window 13 is opened. Blood from the diaphragm pump 320 enters the bidirectional valve 100 through the main tube 312 and flows into the ascending aorta 420 through the first window 13, thus completing one blood pumping cycle. Once the main tube 312 is filled with blood, it is connected to the diaphragm pump 320 and the main unit 330. The pumping frequency of the main unit 330 and the diaphragm pump 320 is coordinated with the heart rate to push the medium, thus forming a blood pumping operation.

[0061] It should be noted that the catheter tip 311 can be a tubular structure with an open end or a closed end, and a corresponding second window 313 is provided on the side wall of the catheter tip 311, such as... Figure 6 In the example, when the heart 410 contracts, blood in the ventricles can flow from the catheter tip 311 into the bidirectional valve 100, and then from the main tube 312 into the diaphragm pump 320.

[0062] The following describes specific examples of the bidirectional valve 100 and the ventricular assist device 300 of this application with reference to the accompanying drawings.

[0063] like Figures 1 to 14As shown, in the bidirectional valve 100 of the ventricular assist intervention device 300, the valve body 1 and the valve disc 2 adopt a hollow tubular structure made of titanium alloy or 316L stainless steel; the thickness of the valve body middle part 10 is 0.1mm to 0.3mm, the thickness of the proximal end 11 and the distal end 12 of the valve body 1 is 0.1mm to 0.28mm, and the thickness of the valve body middle part 10 is greater than the thickness of the proximal end 11 and the thickness of the distal end 12; the diameter of the valve body 1 is 4.2mm to 5.0mm, the shape of the first window 13 of the valve body 1 adopts an elliptical or circular cross-section smooth shape, and the area of the first window 13 is 25mm² to 40mm²; the maximum protruding distance of the thickened part 14 in the first direction is 0.3mm to 1mm, that is, the thickened part 14 protrudes by a distance of 0.3mm to 1mm towards the inside of the valve body 1. The valve disc 2 is a one-piece structure, specifically a one-piece design; the maximum thickness of the valve disc 2 is 0.3mm to 1mm, the width of the valve disc 2 is 2mm to 5mm, and the length of the valve disc 2 is 6mm to 8mm. Among them, the first angle a is formed between the first arc segment 21 and the second arc segment 22, the first angle a is away from the first window 13, and the first angle a is in the range of 90° to 180°, preferably in the range of 120° to 160°; the second arc segment 22 of the valve disc 2 has a chamfer structure 24 near the position of the distal end 12, the second angle b is formed between the chamfer structure 24 and the second arc segment 22, the second angle b is away from the first window 13, and the second angle b is in the range of 120° to 155°, and the length of the chamfer structure 24 is 0.5mm to 1.8mm.

[0064] As Figure 3 the example in the valve body 1 inside the second direction on both sides of the inner side wall is provided with coaxial connecting column 16, the two sides of the valve disc 2 through the corresponding connecting hole 23 and the corresponding connecting column 16 rotationally connected, then the center line of the connecting column 16 is the rotation axis of the valve disc 2. Among them, as Figures 3 to 5 the example in the first direction, the connecting column 16 is located in the middle position in the valve body 1, and the connecting column 16 is correspondingly arranged with one end of the first window 13 close to the proximal end 11; the size of the two sides of the valve disc 2 gradually shrinks towards the direction close to the rotation axis, so that the two sides of the valve disc 2 form a structure similar to an inverted triangle.

[0065] As Figure 6 the example, the diaphragm pump 320 of the ventricular assist intervention device 300, the diaphragm pump 320 has a blood chamber capable of containing blood and a medium chamber capable of containing medium, the blood chamber and the medium chamber are separated by a diaphragm, and the diaphragm can be flexibly deformed. Among them, the blood chamber is connected with the main conduit 312, and the medium chamber is connected with the main machine device 330 through the pipeline.

[0066] For a patient in need of a ventricular assist intervention, a femoral artery of the patient can be punctured and a guide wire used to guide a catheter assembly 310 into the patient's aorta such that the second window 313 of the catheter tip 311 is located in the left ventricle and the bi-directional valve 100 is located in the region of the aortic arch 421 outside the heart 410 (e.g. Figure 7 When the blood fills the main catheter 312, the main catheter 312 and the extracorporeal membrane pump 320 and the main unit 330 are connected, and the main unit 330 pushes the medium in coordination with the heart rate, thereby pumping blood.

[0067] For example, as Figure 6 and Figure 7In the example in the heart 410 systole, the blood in the heart 410 through the conduit front end 311 of the second window 313 into the conduit front end 311 and flow to the bidirectional valve 100, at this time the blood push valve 2 close to the valve body 1 inner surface, the second arc segment 22 of valve 2 is attached to the first window 13 near the thickening part 14 of the distal end 12, and the first window 13 of the bidirectional valve 100 is closed, the blood from the heart 410 to the blood chamber of the diaphragm pump 320 is unobstructed, and the blood is stored in the blood chamber of the diaphragm pump 320. Among them, because the second arc segment 22 of the valve 2 is slightly depressed by the thickening part 14, it is not directly attached to the inner side of the valve body 1 parallel to the first window 13, so that the valve 2 is away from the unstable area of the main conduit 312 near the first window 13 segment, and the valve 2 is more stable in work. In the diastolic phase of the heart 410, the host device 330 pumps the medium into the medium chamber of the diaphragm pump 320, at this time the fluid medium gradually fills, and the diaphragm in the diaphragm pump 320 is also pushed to deform, pushing the blood in the blood chamber into the conduit assembly 310; At this time, the valve 2 is driven by gravity and other forces to rotate away from the inner surface of the valve body 1 opposite the first window 13, so that the first arc segment 21 abuts against one end of the first window 13 near the proximal end 11, which can block the blood from flowing outwards and stabilize the valve 2; The region of the second arc segment 22 away from the first arc segment 21 abuts against the side wall of the valve body 1 away from the first window 13, so that the valve 2 blocks the passage between the proximal end 11 and the distal end 12 inside the valve body 1, that is, it blocks the passage of blood backflow in the conduit assembly 310; At this time, the blood pumped by the diaphragm pump 320 into the bidirectional valve 100 flows into the ascending aorta 420 under the guidance of the valve 2. Among them, the cutting angle structure 24 at one end of the second arc segment 22 away from the first arc segment 21 can quickly open the first window 13 during the blood flow from the distal end 12, so that the distal end 12 is communicated with the first window 13, and the blood flow direction is closer to the middle area of the first window 13 when the blood flows through the first window 13, so that the blood can enter the ascending aorta 420 more stably. The blood flows from the valve body 1 into the ascending aorta 420 to generate additional blood flow for the patient, forming a primary circulation. Among them, the diaphragm pump 320 pumps back and forth once per heart beat, and the host device 330 controls the pushing frequency of the medium according to the heart beat frequency of the patient, thereby realizing the function of assisting the ventricle to pump blood.

[0068] The ventricular assist intervention device 300 in the embodiment can avoid the unstable blood flow area near the first window 13 in the main conduit 312 by improving and optimizing the structure of the bidirectional valve 100, so that the valve disc 2 can keep a stable state, the first window 13 always keeps a closed state, and the shear stress of the blood cells in the blood by the bidirectional valve 100 is optimized, which is beneficial to reduce hemolysis and reduce the adverse effect on the assist intervention effect. Moreover, the second arc segment 22 is shortened by the abutment of the thickened part 14 and the second arc segment 22, the force required for the rotation of the valve disc 2 is also reduced, so that the area of the first window 13 on the valve body 1 can be increased to further increase the blood flow to the heart assist pump, which is beneficial to further improve the heart blood pumping burden of the patient.

[0069] In addition, the ventricular assist intervention device 300 in the embodiment also has all the beneficial effects of the bidirectional valve 100 in any of the above embodiments, which will not be repeated here.

[0070] The above application of specific examples is used to help understand the application and does not limit the application. For those skilled in the art to which the application belongs, according to the idea of the application, a number of simple deductions, deformations or substitutions can be made.

Claims

1. A two-way valve, characterized in that, include: The valve body is a tubular structure with a proximal end and a distal end arranged opposite to each other. In a first direction perpendicular to the axial direction of the valve body, a first window is provided on one side wall of the valve body. The inner side wall of the region of the first window near the distal end has a thickened portion. The thickened portion is integrally formed with the valve body. The thickened portion protrudes towards the inner side of the valve body. In the first direction, the maximum distance of the thickened portion protruding towards the inner side of the valve body is in the range of 0.3mm to 1mm. In the direction along the axial direction of the valve body from the distal end to the proximal end, the thickened portion gradually extends towards the inner side of the valve body. A valve disc is rotatably disposed within the valve body and corresponding to the first window. The shape of the valve disc is adapted to the first window, and the valve disc is capable of rotating relative to the valve body between a first state position and a second state position. The inner side of the thickened portion has an arc-shaped surface that is adapted to the valve disc; In the first state position, the valve disc closes the proximal end of the valve body, and the distal end communicates with the first window; In the second state position, the valve flap closes the first window, and the valve flap abuts against the thickened portion, and the thickened portion forms a surface contact with the valve flap in the circumferential direction, with the proximal end communicating with the distal end.

2. The bidirectional valve according to claim 1, characterized in that, The valve disc includes a first arc segment and a second arc segment connected to each other. The first arc segment is closer to the proximal end relative to the rotation axis of the valve disc, and the second arc segment is closer to the distal end relative to the rotation axis. In a plane perpendicular to the axis of rotation, the first arc segment and the second arc segment form a first angle, the first angle being located on the side of the valve disc facing away from the first window, and the first angle being within the angle range of (90°, 180°).

3. The bidirectional valve according to claim 2, characterized in that, The second direction is perpendicular to the first direction and perpendicular to the axial direction of the valve body. The valve body has a first connecting structure on both inner sidewalls in the second direction. In the first direction, the first connecting structure is disposed opposite to the edge of the first window near the proximal end. The valve disc is an integral structure, and the valve disc has a second connecting structure on each side in the second direction, and the second connecting structure is rotatably connected to the corresponding first connecting structure. In the first connection structure and the second connection structure, one is a connecting post and the other is a connecting hole or a connecting groove.

4. The bidirectional valve according to claim 2, characterized in that, In a plane perpendicular to the axis of rotation, the length of the second arc segment is greater than the length of the first arc segment; In the first direction, the rotation axis is set to correspond to the end of the first window near the proximal end.

5. The bidirectional valve according to claim 2, characterized in that, In the first state position, the area on the first arc segment away from the second arc segment abuts against the edge of the first window near the proximal end, the second arc segment abuts against the inner wall of the valve body away from the first window in the first direction, and the valve disc closes the proximal end in the axial direction of the valve body; In the second state position, the area on the first arc segment near the second arc segment abuts against the edge of the first window near the proximal end, the second arc segment abuts against the inner side of the thickened portion, and the valve flap closes the first window.

6. The bidirectional valve according to claim 2, characterized in that, The end of the second arc segment away from the first arc segment has a chamfered structure, and the chamfered structure forms a second angle with the side of the second arc segment facing away from the first window. Wherein, the angle range of the second included angle is 120° to 155°; and / or, The length of the chamfered structure is in the range of 0.5mm to 1.8mm.

7. The bidirectional valve according to claim 1, characterized in that, The inner side of the thickened portion has a flexible buffer layer, which can abut against the valve disc.

8. The bidirectional valve according to claim 1, characterized in that, The maximum thickness of the valve disc is in the range of 0.1 mm to 0.3 mm.

9. The bidirectional valve according to claim 1, characterized in that, The portion of the valve body located between the proximal end and the distal end is the middle part of the valve body, and the thickness of the middle part of the valve body is greater than the thickness of the proximal end and the thickness of the distal end. The thickness of the proximal end and the distal end is in the range of 0.1 mm to 0.28 mm, and the thickness of the middle part of the valve body is in the range of 0.1 mm to 0.3 mm.

10. A ventricular assist interventional device, characterized in that, include: A catheter assembly comprising a catheter tip, a bidirectional valve as described in any one of claims 1 to 9, and a main tube connected in sequence; A diaphragm pump, one end of which is connected to the end of the main pipe away from the bidirectional valve; A main unit is connected to the end of the diaphragm pump away from the main tube, and the main unit is used to drive the diaphragm pump to pump blood into the bidirectional valve.

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