Two-way valve and ventricle auxiliary device

Abstract

The invention relates to the technical field of medical instruments, and discloses a two-way valve and a ventricle assisting device. The two-way valve comprises a valve body, the valve body is of a tubular structure with a proximal end and a telecentric end, a window is formed in the side wall of one side of the valve body, and a first contact area is arranged on the edge of the end, close to the telecentric end, of the window on the inner side wall of the valve body; the valve clack is rotatably arranged in the valve body, a concave part is arranged on the side, facing the window, of a telecentric arc section of the valve clack, a valve clack contact area is arranged at the position, opposite to the first contact area, of the valve clack, and the valve clack can rotate between a first state position and a second state position relative to the valve body. The opening window is opened or closed. According to the technical scheme, when the valve clack rotates to the first state position, the blood outflow path is increased due to the concave part of the telecentric arc section of the valve clack, so that the blood outflow amount is further increased, and the effect of assisting in pumping out blood is improved.

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 device. BACKGROUND

[0002] Heart failure is a disease caused by dysfunction of the heart to transport blood, which means that the heart cannot maintain normal blood transport capacity to meet the body's demand for oxygen and nutrients. Heart failure is the only heart disease with a growing trend worldwide, and there are currently more than 260 million heart failure patients worldwide. Studies have shown that the incidence of heart failure in the population is 3%, while the incidence in the elderly population is 10-20%, and most of the patients are indeed elderly people over 65 years old. Because the number of heart failure patients is increasing year by year, and chronic heart failure is the end stage of various cardiovascular diseases, the incidence is also increasing year by year, and it has become a serious problem in clinical practice. If early heart failure patients do not pay attention and miss the best diagnosis opportunity, as heart failure worsens, when the heart cannot transport enough blood to maintain the normal work of the body, in this case, the heart needs to be assisted by a ventricular assist device to pump blood.

[0003] The most advanced percutaneous coronary intervention (PCI) technology of the present era provides treatment strategies and solutions for an increasing number of heart failure (HF) and complex coronary artery disease patients. Patients with left ventricular dysfunction, or those with complex anatomy and severe complications who are delayed for surgery can only be eligible for percutaneous treatment. However, even in this case, PCI is still a high-risk operation, which is prone to major complications and even causes the death of patients. The purpose of percutaneous mechanical circulatory support (MCS) is to reduce the mechanical and energy load of the failing ventricle by reducing left ventricular pressure and volume and increasing coronary blood flow (CBF). Patients with advanced atrial fibrillation and severely impaired left ventricular systolic function are most likely to be affected and therefore most likely to benefit from MCS.

[0004] Percutaneous ventricular assist device (pVAD) is a device that helps the heart work for a short time, or temporarily replaces the work of the heart when the heart cannot work. It is usually inserted into the body through the skin (percutaneously) and then connected to the heart to help or take over the pumping function of the heart. It is used in emergency situations such as intraoperative and postoperative short-term cardiac support for high-risk percutaneous coronary intervention (PCI) patients and cardiogenic shock patients. Therefore, the design of pVAD focuses more on miniaturization, convenience and minimally invasive.

[0005] The problem of the prior art is that in the prior art, due to the diameter restriction of the bidirectional valve caused by the inherent diameter of the blood vessel, the flow of the auxiliary heart blood pumping is insufficient. And in the prior art, when the bidirectional valve is opened, the distal end side of the valve disc abuts against the inside of the valve body, and then forms a certain angle with the inside of the valve body, so that the pumped blood cannot keep (relative to the valve body) vertical outflow to the blood vessel wall. Such inclined outflow angle will generate a reaction force, which may push the bidirectional valve and the catheter together to displace in the blood vessel, and after time accumulation, it may cause the risk of ectopia of the bidirectional valve and disengagement of the front end of the catheter from the original position, and then produce the consequences of insufficient assistance, reduce the treatment effect and delay the treatment opportunity.

[0006] The purpose of the application is to solve the problem of insufficient flow of the auxiliary heart blood pumping of the bidirectional valve component of the left ventricular assist device.

[0007] More specifically, the technical scheme of the application mainly relates to an improved bidirectional valve composed of a valve body and a valve disc. The most important technical point is that the valve disc is designed in one piece, the proximal end side of which is connected to the valve body through a shaft, and the distal end side of the valve disc is designed as a structure with a concave arc towards the windowed part. SUMMARY

[0008] In order to solve the problem of insufficient flow of the auxiliary heart blood pumping of the one-piece valve disc in the bidirectional valve component of the left ventricular assist device in the prior art, the application provides a bidirectional valve and a ventricular assist device.

[0009] The embodiment of the application discloses a bidirectional valve, characterized in that it comprises:

[0010] a valve body, the valve body being a tubular structure, and the valve body having oppositely arranged proximal and distal ends, a windowed opening 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 wall of the valve body having a first contact area at the edge of the windowed opening close to the distal end;

[0011] A valve disc is rotatably arranged in the valve body and corresponds to the opening window, and the valve disc has a second contact area opposite to the first contact area, and the side of the valve disc facing the opening window has a recess structure extending to the second contact area; the valve disc can be connected and relatively moved in the valve body, and the valve disc can rotate relative to the valve body between a first state position and a second state position; in the first state position, the valve disc closes the proximal end of the valve body, the distal end is in communication with the opening window; in the second state position, the valve disc closes the opening window, the second contact area is in contact with the first contact area, and the proximal end is in communication with the distal end.

[0012] Further, the valve disc comprises two arc segments connected with each other, i.e. a proximal arc segment and a distal arc segment, the proximal arc segment is close to the proximal end relative to the rotation axis, and the distal arc segment is close to the distal end relative to the rotation axis; in the projection plane perpendicular to the rotation axis, the projection of the proximal arc segment forms a first included angle with the projection of the distal arc segment, the first included angle is on the side of the valve disc facing the valve body, and the first included angle is in the angle range of (90°, 180°].

[0013] Further, the second direction is perpendicular to the first direction and the axial direction of the valve body, the valve body has a first connecting structure on the inner side wall on both sides in the second direction, and in the first direction, the first connecting structure is arranged opposite to the edge of the opening window close to the proximal end.

[0014] Further, the valve disc is a one-piece structure, and the valve disc has a second connecting structure on both sides in the second direction, and the second connecting structure is rotationally connected with the corresponding first connecting structure; 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.

[0015] Further, in the first state position, the proximal arc segment is in contact with the edge of the opening window close to the proximal end, the distal arc segment is in contact with the inner side wall of the valve body away from the opening window in the first direction, and the valve body closes the proximal end in the axial direction of the valve body.

[0016] Further, in the second state position, the area close to the proximal arc segment on the proximal arc segment is in contact with the edge of the opening window close to the proximal end, the distal arc segment is in contact with the first contact area, and the valve disc closes the opening window.

[0017] Further, the far end of the telecentric arc segment has a cut corner structure, and the cut corner structure and the side of the telecentric arc segment away from the window form a second included angle; wherein the second included angle ranges from 120° to 155°.

[0018] Further, the length of the cut corner structure ranges from 0.5 mm to 1.8 mm.

[0019] Further, the second contact area of the valve disc contact area and / or the first contact area of the valve body contact area is a flexible structure.

[0020] Further, the material of the flexible structure can be polyvinyl chloride (PVC) or polyamide (PA).

[0021] Further, the recessed structure has a deepest recessed distance in the first direction, and the deepest recessed distance ranges from 0.1 mm to 3 mm.

[0022] Further, the area of the recessed structure ranges from 10 mm to 40 mm 2 .

[0023] The embodiment of the second technical solution of the present application also provides a ventricular assist device, which comprises: a catheter assembly, the catheter assembly comprising a catheter front end, a bidirectional valve as described above, and a catheter connected in sequence; a diaphragm pump, one end of the diaphragm pump being connected to the end of the catheter away from the bidirectional valve; and a main machine, the main machine being connected to the end of the diaphragm pump away from the catheter, and the main machine being used to drive the diaphragm pump to pump blood into the catheter assembly.

[0024] The bidirectional valve of the present application has the following advantages: the valve disc is designed in a one-piece manner, the proximal end side of the valve disc is connected to the valve body through a shaft, and the part of the distal end side of the valve disc facing the window is designed as a structure with a recessed curvature. The improved technical solution can improve the flow rate of the auxiliary heart pump and make the heart assistance more sufficient. BRIEF DESCRIPTION OF DRAWINGS

[0025] The accompanying drawings are included to provide a further understanding of the preferred embodiments and are incorporated in and constitute a part of this specification. The drawings are not intended to be restrictive in any way, and like reference numerals are used throughout the various views of the drawings, in which:

[0026] Figure 1 is a perspective view of the bidirectional valve

[0027] Figure 2 is a top view of the bidirectional valve

[0028] Figure 3 is a cross-sectional view of the bidirectional valve in the systolic phase according to an embodiment of the present application

[0029] Figure 4Cross-sectional view of a diastolic bidirectional valve according to an embodiment of the present application

[0030] Figure 5 Cross-sectional view of a systolic bidirectional valve according to another embodiment of the present application

[0031] Figure 6 Cross-sectional view of a diastolic bidirectional valve according to another embodiment of the present application

[0032] Figure 7 System diagram of a ventricular assist device

[0033] In the above figures, arrow F1 represents a first direction, arrow F2 represents a second direction, and arrow F3 represents an axial direction of the valve body

[0034] Legend of reference signs:

[0035] 10: valve body, 101: middle section of valve body, 102: proximal end, 103: distal end, 104: windowed opening, 105: first contact area, 106: first connecting structure

[0036] 20: valve leaflet, 201: proximal arc section, 202: distal arc section, 203: second contact area, 204: second connecting structure, 205: chamfer structure, 206: recess structure

[0037] 30: ventricular assist device, 301: catheter, 302: bidirectional valve, 303: catheter front end, 304: diaphragm pump, 305: main unit DETAILED DESCRIPTION

[0038] Exemplary embodiments of the present disclosure will be described in greater detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it is understood that the present disclosure can be embodied in various forms without being limited by the embodiments set forth herein. Rather, these embodiments are provided so that the present disclosure will be thoroughly and completely understood, and will fully convey the scope of the present disclosure to those skilled in the art.

[0039] It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises", "comprising", "includes", "including" and "has" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their

[0040] Although the terms first, second, third, etc. can be used herein to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first", "second", and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

[0041] Spatially relative terms, such as "inner", "outer", "inward", "outward", "lower", "bottom", "top", "upper", and the like, can be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. Such spatially relative terms can encompass different orientations of the device in use or operation in addition to the orientations depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the exemplary term "below" can encompass both an orientation of above and below. The device can be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0042] In the description of this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0043] Furthermore, in the description of this invention, "proximal end" refers to the side closer to the heart after the structure shown in the technical solution is inserted into the human body; while "distal end" refers to the side further away from the heart after the structure shown in the technical solution is inserted into the human body.

[0044] The bidirectional valve 302 provided in this application can be installed in the catheter 301 of the ventricular assist device to generate additional blood flow during cardiac interventional treatment. The rotation of the bidirectional valve 302 enables the switching between the distal end 103 and the proximal end 102 of the catheter 301 or between the distal end 103 of the catheter 301 and the aorta, and the switching frequency is adapted to the frequency of the heart pumping pulse, thereby realizing the auxiliary blood supply function.

[0045] The following describes some embodiments of the bidirectional valve 302 and ventricular assist device provided in this application with reference to the accompanying drawings.

[0046] An embodiment of the first aspect of this application provides a two-way valve 302, such as Figures 1 to 4 As shown, it includes: a valve body 10, which is a tubular structure and has a proximal end 102 and a distal end 103 disposed opposite to each other. In a first direction perpendicular to the axial direction of the valve body 10, an opening window 104 is provided on one side wall of the valve body 10, and a first contact area 105 is provided on the inner side wall of the valve body 10 at the edge of the opening window 104 near the distal end 103.

[0047] The valve disc 20 is rotatably disposed within the valve body 10 and correspondingly disposed with the opening window 104. The valve disc 20 has a second contact area 203 at a position opposite to the first contact area 105. The valve disc 20 has a recessed structure 206 on the side facing the opening window 104, and the recessed structure 206 extends all the way to the second contact area 203. The valve disc 20 can move relative to the valve body 10 through a certain connection method, and the valve disc 20 can rotate relative to the valve body 10 between a first state position and a second state position.

[0048] In the first state position, the valve disc 20 closes the proximal end 102 of the valve body 10, the distal end 103 communicates with the windowed opening 104; in the second state position, the valve disc 20 closes the windowed opening 104, the second contact area 203 abuts against the first contact area 105, and the proximal end 102 communicates with the distal end 103.

[0049] The valve disc 20 comprises two arc segments connected with each other, i.e., a proximal arc segment 201 and a distal arc segment 202, the proximal arc segment 201 is close to the proximal end 102 relative to the rotation axis, and the distal arc segment 202 is close to the distal end 103 relative to the rotation axis; wherein, in the projection plane perpendicular to the rotation axis, the projection of the proximal arc segment 201 forms a first included angle with the projection of the distal arc segment 202, the first included angle is located on the side of the valve disc 20 facing the valve body 10, and the first included angle is in the angle range of (90°, 180°].

[0050] The valve disc 20 is of an integral structure, and the valve disc 20 has a second connecting structure 203 on each side in the second direction, and the second connecting structure 203 is rotationally connected with the corresponding first connecting structure 106; wherein, one of the first connecting structure 106 and the second connecting structure 203 is a connecting column, and the other is a connecting hole or a connecting groove. It should be noted that the connecting column and the connecting hole can be interchanged, and the connecting hole can be replaced by the connecting groove. Wherein, the valve disc 20 adopts an integral structure, which can be integrally formed in the process of manufacturing, without the need for assembly in the later stage, which is beneficial to simplify the process flow.

[0051] In the first state position, the proximal arc segment 201 abuts against the edge of the windowed opening 104 close to the proximal end 102, the distal arc segment 202 abuts against the inner side wall of the valve body 10 in the first direction away from the windowed opening 104, and the proximal end 102 is closed in the axial direction of the valve body 10. In the second state position, the area close to the proximal arc segment 201 on the proximal arc segment 201 abuts against the edge of the windowed opening 104 close to the proximal end 102, the distal arc segment 202 abuts against the first contact area 105, and the valve disc 20 closes the windowed opening 104.

[0052] In an embodiment, as shown in Figures 3 to 4, the distal arc segment 202 of the bidirectional valve 302 has a concave structure 206 that is concave to the inside of the valve body 10, but the distal side of the distal arc segment 202 is still tilted towards the window 104. Specifically, during the systole of the heart, the blood in the heart enters the catheter 301 through the window 104 at the front end 303 of the catheter, at this time the blood pushes the valve disc 20 close to the inner surface of the valve body 10, and the distal arc segment 202 of the valve disc 20 is attached to the inside of the valve body 10. The distal arc segment 202 has a concave structure 206 that is concave to the inside of the valve body 10, but the distal side of the distal arc segment 202 is still tilted towards the window 104, so that the window 104 of the bidirectional valve 302 can be closed, and the tilted part can block the gap between the inside of the valve body 10 and the window 104 when the valve disc 20 is closed, so that during the systole of the heart, blood does not leak out of the bidirectional valve 302, thereby affecting the stability of the operation of the valve disc 20. During this period, the blood in the catheter 301 flows unimpeded from the heart to the blood cavity of the extracorporeal diaphragm pump 304, and the blood is stored in the blood cavity of the extracorporeal diaphragm pump 304. During the diastole of the heart, the pumping medium in the extracorporeal host 305 is pumped into the medium cavity of the extracorporeal diaphragm pump 304, at this time the fluid medium gradually fills, and the diaphragm is also pushed to deform, pushing the blood in the blood cavity into the catheter 301, and the blood flows from the distal end 103 to the proximal end 102. When the valve disc 20 is in the first state position, the blood enters the valve body 10 from the distal end 103 of the valve body 10, and due to the gravity of the bidirectional valve disc 20 described in the present scheme, it falls to the opposite side of the valve body 10 to the inside surface of the valve body 10 at the window 104, and the blood flows to the window 104 under the guidance of the distal arc segment 202, and flows to the aorta through the window 104. At this time, the valve disc 20 blocks in the valve body 10, blocking the path of the blood in the catheter 301 from flowing back. After the valve disc 20 falls, the window 104 of the valve body 10 is opened, connecting the inside of the catheter 301 and the aorta, and due to the concave structure 206 of the distal arc segment 202 of the valve disc 20, the angle of the blood coming from the distal end 103 of the diaphragm pump 304 is changed, and the blood can flow out to the artery at a more gentle angle, reducing the possibility of movement of the bidirectional valve 302 in the artery, making it more stable in the blood vessel. Further, the presence of the concave structure 206 increases the volume of blood flow, increasing the flow to the aorta during diastole. During this cycle, blood can be pushed from the extracorporeal diaphragm pump 304 into the catheter 301, but because the valve disc 20 blocks the blood from flowing back to the heart, the blood flows out of the window 104 of the valve body 10 and into the aorta, generating additional blood flow for the patient, forming a cycle.

[0053] In yet another embodiment, as Figures 5 to 6, the distal arc segment 202 of the valve disc 20 has a concave structure 206 that is concave to the inner side of the valve body 10, but the distal side of the distal arc segment 202 is bent to the side of the opening window 104 of the valve body 10, and the side of the distal arc segment 202 facing the opening window 104 is arc-shaped or beveled. Specifically, during the systole of the heart, the blood in the heart enters the catheter 301 through the opening window 104 of the catheter front end 303, at this time the blood pushes the valve disc 20 close to the inner surface of the valve body 10, and the distal arc segment 202 of the valve disc 20 is attached to the inner side of the valve body 10. The distal arc segment 202 has a concave structure 206 that is concave to the inner side of the valve body 10, but the distal side of the distal arc segment 202 is still tilted to the side of the opening window 104, so that the opening window 104 of the two-way valve 302 can be closed, and the tilted part can block the gap between the inner part of the valve body 10 and the opening window 104 when the valve disc 20 is closed, so that blood does not leak from the two-way valve 302 during the systole of the heart, thereby affecting the operation stability of the valve disc 20. During this period, the blood in the catheter 301 flows from the heart to the blood cavity of the extracorporeal diaphragm pump 304 without obstruction, and the blood is stored in the blood cavity of the extracorporeal diaphragm pump 304. During the diastole of the heart, the pumping medium in the extracorporeal host 305 is pumped into the medium cavity of the extracorporeal diaphragm pump 304, at this time the fluid medium is gradually filled, and the diaphragm is also pushed to deform, pushing the blood in the blood cavity into the catheter 301, and the blood flows from the distal end 103 to the proximal end 102. The distal arc segment 202 of the valve disc 20 has a cut corner structure 205, which is located at one end of the distal arc segment 202 away from the proximal arc segment 201, and is inclined relative to the distal arc segment 202, so that a second included angle is formed between the cut corner structure 205 and the distal arc segment 202, and the second included angle is away from the opening window 104. The angle of the second included angle is in the range of 120° to 155°, i.e. on the side facing the opening window 104, the cut corner structure 205 is inclined to the distal arc segment 202 by 25° to 60°.

[0054] Further, in the present embodiment, since the telecentric arc segment 202 is provided with the cut corner structure 205, and the cut corner structure 205 is bent to the side away from the window 104, the blood flow from the proximal end 102 to the distal end 103 at the same time produces a thrust on the telecentric arc segment 202 and the cut corner structure 205, so that the rotation angle of the valve disc 20 is raised, which is more conducive to the response of the valve disc 20 to the direction of blood flow. When the valve disc 20 is in the first state position, the blood enters the valve body 10 from the distal end 103 of the valve body 10, and contacts the cut corner structure 205 and the telecentric arc segment 202. The blood flowing into the valve body 10 from the distal end 103 forms a pressure on the cut corner structure 205, so that the valve disc 20 can effectively convert the blood pressure into a torque on the rotation shaft, thereby significantly reducing the blood pressure required for the valve disc 20 to open, and making the response speed of the valve disc 20 when opening faster. And because of the gravity of the valve disc 20 of the bidirectional valve 302 described in the present solution, the valve disc 20 falls to the inner surface of the valve body 10 on the opposite side of the window 104 of the valve body 10. The blood flows to the window 104 under the guidance of the cut corner structure 205 and the telecentric arc segment 202, and flows to the aorta through the window 104. At this time, the valve disc 20 blocks inside the valve body 10, blocking the passage of blood backflow in the catheter 301. After the valve disc 20 falls, the window 104 of the valve body 10 is opened, connecting the passage between the inside of the catheter 301 and the aorta, and because of the concave structure 206 of the telecentric arc segment 202 of the valve disc 20, the angle of the blood flowing out from the distal end 103 of the diaphragm pump 304 is changed, and the blood can flow out to the artery at a more gentle angle, reducing the possibility of movement of the bidirectional valve 302 in the artery, making it more stable in the blood vessel.

[0055] Further, the presence of the concave structure 206 increases the volume of blood flow, which increases the flow to the aorta during diastole. In addition, when the valve disc 20 is in the first state position, the valve disc 20 with the cut corner structure 205 can guide the blood to flow through the window 104 more close to the center of the window 104, which can reduce the impact on the aorta and make the blood flow more smoothly into the aorta. According to actual needs, the cut corner structure 205 can be set as a slope or an arc towards the side of the window 104, so that the blood flowing through the cut corner structure 205 to the window 104 can be more stable and smooth. During the rotation of the valve disc 20 from the first state position to the second state position, the telecentric arc segment 202 receives a large blood thrust, and because of its large torque, it can speed up the response speed of the valve disc 20, so that the valve disc 20 can rotate to the second state position more quickly. In summary, in such a cycle, blood can be pushed from the extracorporeal diaphragm pump 304 into the catheter 301, but because the valve disc 20 blocks the blood from flowing back to the heart, the blood flows out from the window 104 of the valve body 10 and flows into the aorta, generating additional blood flow for the patient and forming a cycle.

[0056] In yet another embodiment, the second contact area 203 is a flexible structure on the distal side of the distal arc segment 202 of the valve disc 20. When the valve disc 20 is rotated to the first state position to close the proximal end 102, as shown in the state shown in Figure 3 or Figure 5 the distal end 103 communicates with the window 104; when the valve disc 20 is rotated to the second state position, the window 104 is closed by the valve disc 20, and the proximal end 102 communicates with the distal end 103. In this embodiment, the inner side wall of the valve body 10 has a first contact area 105, and the first contact area 105 is located at the edge of the window 104 towards the distal end 103; correspondingly, the valve disc 20 has a second contact area 203 corresponding to the first contact area 105 near the distal end 103, and the second contact area 203 is a flexible structure. When the valve disc 20 is rotated to the second state position, the second contact area 203 abuts against the first contact area 105, and the flexible structure absorbs a part of the impact force, so that the opening and closing process of the valve disc 20 is more stable, and the efficiency and stability of blood delivery are improved.

[0057] The ratio of the symmetry axes of the proximal end segment 201 and the distal end segment 202 of the valve disc 20 along the central axis of the valve body 10 ranges from 1.1 to 2. The area ratio of the proximal end segment 201 and the distal end segment 202 of the valve disc 20 ranges from 1.1 to 2.5.

[0058] In the embodiment of the second aspect of the present application, a ventricular assist device is provided, as shown in Figure 7As shown, the device includes: a catheter assembly comprising a catheter tip 303, a bidirectional valve 302 as described above, and a catheter 301 connected in sequence; a diaphragm pump 304, one end of which is connected to the end of the catheter 301 away from the bidirectional valve 302; and a main unit 305, which is connected to the end of the diaphragm pump 304 away from the catheter 301, and the main unit 305 is used to drive the diaphragm pump 304 to pump blood into the catheter assembly. In use, the catheter tip 303 extends into the left ventricle, and the bidirectional valve 302 is located within the aorta. When the heart contracts, blood flows from the ventricle into the catheter tip 303. When passing through the bidirectional valve 302, the valve disc 20 rotates to the second position, at which point the opening window 104 is closed, and the proximal end 102 and distal end 103 of the valve body 10 are connected, allowing blood to flow through the bidirectional valve 302 and the catheter 301 into the external diaphragm pump 304. The blood flows from the proximal end 102 to the distal end 103. When the heart relaxes, the valve disc 20 of the bidirectional valve 302 rotates to the first position. At this time, the channel between the proximal end 102 and the distal end 103 of the valve body 10 is closed, and the opening window 104 is opened. After the blood in the diaphragm pump 304 enters the bidirectional valve 302 through the catheter 301, it can flow into the aorta through the opening window 104. The blood flows from the distal end 103 to the proximal end 102, thus completing one blood pumping cycle. In this process, once the catheter 301 is filled with blood, the catheter 301 is connected to the diaphragm pump 304 and the main unit 305. The pumping frequency of the main unit 305 and the diaphragm pump 304 is coordinated with the heart rate to push the medium, thereby forming a blood pumping operation.

[0059] It should be noted that the catheter tip 303 can be a tubular structure with open ends or a closed end, and a corresponding window is provided on the side wall of the catheter tip 303 so that when the heart contracts, the blood in the ventricle can flow from the catheter tip 303 into the bidirectional valve 302, and then from the catheter 301 into the diaphragm pump 304.

[0060] The following describes specific examples of the bidirectional valve and ventricular assist device of this application with reference to the accompanying drawings.

[0061] like Figures 1 to 6 As shown, the valve body 10 and valve disc 20 of the bidirectional valve 302 in this application are made of at least titanium alloy or stainless steel 316L. The valve body 10 is a hollow tube with a thickness of 0.5 to 0.3 mm in the middle section. The thickness of each end, from the proximal end 102 to the distal end 103, is reduced to 0.07 to 0.3 mm, primarily for connecting the conduit 301. The inner diameter of the valve body 10 ranges from 4.5 to 5.07 mm. The opening 104 of the valve body 10 should be elliptical, circular, or otherwise smoothly shaped, with an area ranging from 20 to 45 mm². 2The thickness of the valve disc 20 is 0.1-0.3 mm, and the overall profile shape of the valve disc 20 can cover the opening window 104 of the valve body 10, so that the valve disc 20 can completely block the opening window 104 of the valve body 10 during the systole of the heart, and blood cannot flow out. The valve disc 20 is divided into the near-center arc segment 201 and the far-center arc segment 202. The near-center side of the near-center arc segment 201 is fixed to the near-center end 102 of the opening window 104 of the valve body 10 by a pin shaft or other rotatable fixing means. The near-center arc segment 201 and the far-center arc segment 202 of the valve disc 20 are integrally formed. The depth of the first direction of the concave structure 206 of the far-center arc segment 202 is 0.1-3 mm, and the area of the arc surface is 10-40 mm 2 .

[0062] In another embodiment, the valve disc 20 of the far-center arc segment 202 has a cut corner structure 205 on the far-center side. The angle of the cut corner structure 205 is 15°-45°, and the length is 1.3-2.5 times the inner diameter of the valve body 10. The cut corner structure 205 is designed to accommodate the blood flow pushed back during the diastole of the heart, and quickly open the opening window 104 of the valve body 10 to the aorta in response to the change of the flow direction.

[0063] In another embodiment, the film is made of a high-molecular material with certain toughness and hardness, such as polyvinyl chloride (PVC) and polyamide (PA). The thickness of the film is 0.3-0.5 mm, and the area size of the film is 3-8 mm 2 .

[0064] As shown in the example of Figure 2 , coaxial connecting columns are arranged on the inner side walls on both sides of the valve body 10 in the second direction. The two sides of the valve disc 20 are rotationally connected to the corresponding connecting columns through corresponding connecting holes. The center line of the connecting column is the rotation axis of the valve disc 20. In the example of Figures 1 to 5 , in the first direction, the connecting column is located at the middle position in the valve body 10, and the connecting column is arranged corresponding to the end of the opening window 104 close to the near-center end 102.

[0065] As shown in the example of Figure 7 , the diaphragm pump 304 of the ventricular assist intervention device 30 has a blood chamber and a medium chamber. The blood chamber and the medium chamber are separated by a diaphragm, and the diaphragm can be flexibly deformed. The blood chamber is connected to the main conduit 301, and the medium chamber is connected to the main device 305 through a pipeline.

[0066] For a patient in need of ventricular assistance, a puncture can be made from the femoral artery of the patient, and a guide wire is used to guide the catheter 301 assembly into the aorta of the patient, so that the front end window of the front end 303 of the catheter is located in the left ventricle, and the bidirectional valve 302 is located in the aorta outside the heart. After the blood fills the main catheter 301, the main catheter 301 and the extracorporeal diaphragm pump 304 and the main machine 305 device are connected, and the main machine 305 device cooperates with the heart rate to push the medium, and then pumps the blood.

[0067] The above merely provides the preferred embodiments of the present application, but the protection scope of the present application is not limited thereto, and any person skilled in the art can easily think of the changes or replacements within the technical scope disclosed by the present application, which should be covered within the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the protection scope of the claims.

Claims

1. A two-way valve, characterized in that, include: The valve body is a tubular structure and has a proximal end and a distal end that are arranged opposite to each other. In a first direction perpendicular to the axial direction of the valve body, an opening window is provided on one side wall of the valve body, and a first contact area is provided on the inner side wall of the valve body at the edge of the opening window near the distal end. A valve disc is rotatably disposed within the valve body and correspondingly disposed with respect to the opening window. The valve disc has a second contact area at a position opposite to the first contact area. The valve disc has a recessed structure on the side facing the opening window, and the recessed structure extends to the second contact area. The valve disc can be moved relative to the valve body through a certain connection method and can rotate between a first state position and a second state position relative to the valve body. In the first state position, the valve disc closes the proximal end of the valve body, and the distal end is connected to the opening window; In the second state position, the valve flap closes the opening window, the second contact area abuts against the first contact area, and the proximal end is connected to the distal end.

2. The bidirectional valve according to claim 1, characterized in that, The valve disc includes two interconnected arc segments, namely a proximal arc segment and a distal arc segment. The proximal arc segment is closer to the proximal end relative to the rotation axis, and the distal arc segment is closer to the distal end relative to the rotation axis. In the projection plane perpendicular to the rotation axis, the projection of the proximal arc segment and the projection of the distal arc segment form a first angle. The first angle is located on the side of the valve disc facing the valve body, and the first angle is 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 the axial direction of the valve body. The valve body has a first connecting structure on the inner sidewalls on both sides in the second direction. In the first direction, the first connecting structure is disposed opposite to the edge of the opening 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 the first state position, the proximal arc segment abuts against the edge of the opening window near the proximal end, the distal arc segment abuts against the inner wall of the valve body away from the opening window in the first direction, and the valve body closes the proximal end in the axial direction of the valve body. In the second state position, the area near the proximal arc segment abuts against the edge of the opening window near the proximal end, the distal arc segment abuts against the first contact area, and the valve flap closes the opening window.

5. The bidirectional valve according to claim 1, characterized in that, The end of the distal arc segment away from the distal arc segment has a chamfered structure, and the chamfered structure forms a second angle with the side of the distal arc segment facing away from the window; wherein the angle of the second angle ranges from 120° to 155°.

6. The bidirectional valve according to claim 5, characterized in that, 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 valve disc contact area, the second contact area, and / or the valve body contact area, the first contact area, are flexible structures.

8. The bidirectional valve according to claim 1, characterized in that, The recessed structure has a deepest recess distance in the first direction, which is in the range of 0.1 to 3 mm.

9. The bidirectional valve according to claim 1, characterized in that, The area of ​​the recessed structure ranges from 10 to 40 mm. 2 Within the range.

10. A ventricular assist 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 catheter connected in sequence; A diaphragm pump, one end of which is connected to the end of the conduit away from the bidirectional valve; A host unit is connected to the end of the diaphragm pump away from the catheter, and the host unit is used to drive the diaphragm pump to pump blood into the catheter assembly.

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