Two-way valve and ventricular assist system

Abstract

The invention relates to the technical field of medical instruments, and discloses a two-way valve and a ventricular assist system. 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, the upper part of a near-center arc section of the valve clack is hollowed out, a second contact area is arranged at the position, opposite to the first contact area of the valve body, 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 so as to open or close the window. According to the technical scheme, on the premise that the proximal arc section of the valve clack is hollowed out, enough balance weight is provided and the force arm is increased, the telecentric arc section and the corresponding opening window can also be correspondingly enlarged, and therefore the blood outflow amount can be further increased, and the blood pumping assisting effect is improved.

Description

Technical Field

[0001] This invention relates to the technical field of medical devices, and in particular to a bidirectional valve and a ventricular assist system. Background Technology

[0002] Heart failure is a disease caused by impaired cardiac function in pumping blood, meaning the heart is unable to maintain its normal blood-pumping capacity, thus failing to meet the body's needs for oxygen and nutrients. Heart failure is the only heart disease worldwide with an increasing trend, currently affecting over 26 million people globally. Studies show that the prevalence of heart failure in the general population is 3%, while in the elderly it is 10%–20%, with the majority of patients indeed over 65 years of age. Because the number of heart failure patients is increasing year by year, and chronic heart failure, as the end-stage of various cardiovascular diseases, is also showing a rising incidence, it has become an increasingly serious clinical problem. If early-stage heart failure patients do not pay attention and miss the optimal diagnostic window, as heart failure worsens and the heart is unable to pump enough blood to maintain normal bodily functions, a ventricular assist device (VAM) is needed to assist the heart in pumping blood.

[0003] The most advanced percutaneous coronary intervention (PCI) techniques of our time offer treatment strategies and solutions for a growing number of patients with heart failure (HF) and complex coronary artery disease. Patients eligible for PCI are those whose surgery has been delayed due to left ventricular dysfunction, complex anatomy, or severe complications. However, even in these cases, PCI remains a high-risk procedure, prone to serious complications and even death. Percutaneous mechanical circulatory support (MCS) aims to alleviate the mechanical and energy load on 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 likely to be most affected and therefore most likely to benefit from MCS.

[0004] A percutaneous ventricular assist device (pVAD) is a device that provides short-term assistance to the heart or temporarily replaces its function when the heart is unable to function. It is typically inserted through the skin (percutaneously) and then connects to the heart to assist or take over the heart's pumping function. It is used in emergency situations, such as providing short-term cardiac support during and after percutaneous coronary intervention (PCI) for high-risk patients and patients in cardiogenic shock. Therefore, pVADs are designed with a focus on miniaturization, convenience, and minimal invasiveness.

[0005] The problem with the existing technology is that, due to the inherent diameter of the blood vessel and the limitation of the bidirectional valve's inner diameter, insufficient blood flow may occur in assisting the heart's pumping function. Furthermore, in the existing technology, the connection of the valve's rotating shaft on the side closest to the heart has a large rotational arm, causing the bidirectional valve to be unstable and prone to vibration during operation, which may affect the auxiliary pumping effect. The speed or disturbance of blood flow can all become factors affecting valve stability.

[0006] Purpose of the invention: The solution proposed in this application is mainly intended to solve the problem of insufficient blood flow and inadequate assistance in the heart pumping by the bidirectional valve component of the left ventricular assist device.

[0007] More specifically, the technical solution of this application mainly relates to an improved bidirectional valve, which consists of a valve body and a valve disc. The most important technical point is that the valve disc is a one-piece design, with its proximal end connected to the valve body via a shaft, and the upper part of the proximal arc segment of the valve disc is hollowed out. Summary of the Invention

[0008] To address the problem of insufficient blood flow and inadequate assistance in the heart pumping process of a single-piece valve in the bidirectional valve component of existing left ventricular assist devices, this application provides a bidirectional valve and a ventricular assist system.

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

[0010] 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.

[0011] A valve disc is rotatably disposed within the valve body and correspondingly positioned to the opening window. The valve disc has a second contact area opposite to the first contact area, and a hollow portion with a certain proportion of area on its proximal end side. The valve disc can move relative to the valve body via a specific 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 communicates with the opening window. In the second state position, the valve disc closes the opening window, the second contact area abuts against the first contact area, and the proximal end communicates with the distal end, allowing blood to flow through the hollow portion.

[0012] Furthermore, 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. The hollow portion is located on the proximal arc segment. In a 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°, 160°).

[0013] Furthermore, 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, and in the first direction, the first connecting structure is disposed opposite to the edge of the opening window near the proximal end.

[0014] Furthermore, 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; wherein, of the first connecting structure and the second connecting structure, one is a connecting post and the other is a connecting hole or connecting groove.

[0015] Further, in the first state position, the proximal arc segment is close to the edge of the proximal end of the opening window, 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 of ​​the proximal arc segment close to the proximal arc segment abuts against the edge of the opening window close to the proximal end, the distal arc segment abuts against the first contact area, and the valve disc closes the opening window.

[0016] Furthermore, 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 opening window; wherein the angle range of the second angle is 90° to 165°.

[0017] Furthermore, the length of the chamfered structure is in the range of 0.5 mm to 3 mm.

[0018] Furthermore, the second contact area of ​​the valve disc contact area and / or the first contact area of ​​the valve body contact area are flexible structures.

[0019] Furthermore, the flexible structure can be made of a polymer material with a certain degree of toughness and hardness.

[0020] Furthermore, both the proximal arc segment and the distal arc segment have the longest length in the axial direction, and the ratio of the axial length of the proximal arc segment to the distal arc segment is in the range of 0.2 to 1.5.

[0021] Furthermore, the hollow portion occupies a certain area on the proximal arc segment, and the ratio of the area of ​​the hollow portion to the area of ​​the proximal arc segment is in the range of 0.8 to 2.5.

[0022] An embodiment of the second technical solution of this application also provides a ventricular assist system, comprising: a catheter assembly, the catheter assembly including a catheter tip, 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 host unit, the host unit being connected to the end of the diaphragm pump away from the catheter, the host unit being used to drive the diaphragm pump to pump blood into the catheter assembly.

[0023] The advantages of this application are as follows: The bidirectional valve of this application has a one-piece valve disc design, with its proximal end connected to the valve body via a shaft, and the proximal arc segment of the valve disc has a certain proportion of hollowed-out area. The improvement of this technical solution can increase the flow rate of blood pumped by the assisting heart, making the cardiac assistance more sufficient. Attached Figure Description

[0024] The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Furthermore, the same reference numerals are used to identify the same parts throughout the drawings. In the drawings:

[0025] Figure 1 Appearance drawing of a two-way valve

[0026] Figure 2 This is a cross-sectional view of a systolic bidirectional valve according to an embodiment of this application.

[0027] Figure 3 This is a view of the proximal end of a systolic bidirectional valve according to an embodiment of this application.

[0028] Figure 4 This is a cross-sectional view of a diastolic bidirectional valve according to an embodiment of this application.

[0029] Figure 5 A cross-sectional view of a systolic bidirectional valve according to another embodiment of this application.

[0030] Figure 6 A cross-sectional view of a diastolic bidirectional valve according to another embodiment of this application.

[0031] Figure 7 This is a distal end view of a diastolic bidirectional valve according to another embodiment of this application.

[0032] Figure 8 This is an overall view of the valve disc according to another embodiment of this application.

[0033] Figure 9 This is a view of the valve disc proximal end according to another embodiment of this application.

[0034] Figure 10 Diagram of a ventricular assist system device

[0035] In the above figures, arrow F1 indicates the first direction, arrow F2 indicates the second direction, and arrow F3 indicates the axial direction of the valve body.

[0036] Explanation of reference numerals in the attached figures:

[0037] 10: Valve body; 101: Valve body middle section; 102: Proximal end; 103: Distal end; 104: Opening window; 105: First contact area; 106: First connection structure;

[0038] 20: Valve disc; 201: Proximal arc segment; 202: Distal arc segment; 203: Second contact area; 204: Second connection structure; 205: Chamfered structure; 206: Hollowed-out part;

[0039] 30: Ventricular assist device; 301: Catheter; 302: Two-way valve; 303: Catheter tip; 304: Diaphragm pump; 305: Main unit. Detailed Implementation

[0040] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0041] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also mean including the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a specific order as described or illustrated, unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0042] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0043] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, in addition to those depicted in the figure. For example, if the device in the figure is flipped, then an element described as "below other elements or features" or "below other elements or features" will subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] The following describes some embodiments of the bidirectional valve 302 and ventricular assist system provided in this application with reference to the accompanying drawings.

[0048] 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.

[0049] The valve disc 20 is rotatably disposed inside the valve body 10 and is correspondingly disposed in 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 hollow portion 206 with a certain proportion of area on the proximal end 102 side. The valve disc 20 can be moved relative to the valve body 10 through a certain connection method. The valve disc 20 can rotate relative to the valve body 10 between a first state position and a second state position.

[0050] In the first state position, the valve disc 20 closes the proximal end 102 of the valve body 10, and the distal end 103 is connected to the opening window 104; in the second state position, the valve disc 20 closes the opening window 104, the second contact area 203 abuts against the first contact area 105, and the proximal end 102 is connected to the distal end 103.

[0051] The valve disc 20 includes two interconnected arc segments, namely a proximal arc segment 201 and a distal arc segment 202. The proximal arc segment 201 is closer to the proximal end 102 relative to the rotation axis, and the distal arc segment 202 is closer to the distal end 103 relative to the rotation axis. The hollow portion 206 is located on the proximal arc segment 201. In the projection plane perpendicular to the rotation axis, the projection of the proximal arc segment 201 and the projection of the distal arc segment 202 form a first angle. The first angle is located on the side of the valve disc 20 facing inward toward the valve body 10, and the first angle is within the angle range of (90°, 160°). The second direction is perpendicular to the first direction and the axial direction of the valve body 10. The valve body 10 has a first connecting structure 106 on the inner sidewalls on both sides in the second direction. In the first direction, the first connecting structure 106 is disposed opposite to the edge of the opening window 104 near the proximal end 102.

[0052] The valve disc 20 is a one-piece structure, and each of its two sides in the second direction has a second connecting structure 203, which is rotatably connected to the corresponding first connecting structure 106. Of the first connecting structure 106 and the second connecting structure 203, one is a connecting post, and the other is a connecting hole or connecting groove. It should be noted that the connecting post and the connecting hole can be interchanged, and the connecting hole can also be replaced by a connecting groove. The valve disc 20's one-piece structure allows it to be integrally formed during manufacturing, eliminating the need for subsequent assembly and simplifying the process.

[0053] In the first position, the proximal arc segment 201 abuts against the edge of the opening window 104 near the proximal end 102, and the distal arc segment 202 abuts against the inner wall of the valve body 10 away from the window 104 in a first direction, and the valve body 10 closes the proximal end 102 in the axial direction of the valve body 10. In the second position, the area of ​​the proximal arc segment 201 near the proximal arc segment 201 abuts against the edge of the opening window 104 near the proximal end 102, the distal arc segment 202 abuts against the first contact area 105, and the valve disc 20 closes the opening window 104.

[0054] In one embodiment, such as Figures 2 to 4The proximal arc segment 201 of the bidirectional valve 302 has a valve disc perforation of a certain area, namely, the perforated portion 206. In the second state, the part of the proximal arc segment 201 that abuts against the valve body 10 has a certain solid portion. Specifically, during the systolic phase of the heart, blood from the heart enters the catheter 301 through the opening window 104 of the catheter tip 303. At this time, the blood pushes the proximal arc segment 201 of the valve disc 20 away from the solid portion on the side of the window 104, causing the proximal arc segment 201 to press down, and at the same time pushes the distal arc segment 202 closer to the inner surface of the valve body 10, causing the valve disc 20 to close the opening window 104 of the bidirectional valve 302 connecting to the aorta. During this period, blood flows out of the heart, enters the catheter 301 through the catheter tip 303, and passes through the perforated portion 206 of the proximal arc segment 201 to the blood chamber of the external diaphragm pump 304 without obstruction. The blood is stored in the blood chamber of the external diaphragm pump 304. During the diastolic phase of the heart, the external host 305 pumps the medium into the medium chamber of the external diaphragm pump 304. At this time, the fluid medium gradually fills the chamber, and the diaphragm is also pushed to deform, pushing the blood in the blood chamber into the catheter 301. The blood flows from the distal end 103 to the proximal end 102, causing the valve 20 to switch to the first state position. This process is as follows: blood enters the valve body 10 from the distal end 103, and due to the gravity of the bidirectional valve 20 described in this scheme, it falls onto the inner surface of the valve body 10 opposite to the opening window 104. The blood flow pushes the proximal arc segment 201 away from the solid part on the side of the window 104, pushing it towards the opening window 104. As blood rushes in from the distal end 103, the distal arc segment 202 rotates along its axis with the valve disc 20 on the proximal end 102 side, causing it to fall close to the opposite side of the valve body 10 opening window 104, contacting its inner surface and supporting the valve disc 20 on the proximal end 102 side. This stabilizes the blood flow, blocking the passage for blood to return to the ventricle. After the valve disc 20 falls, the valve body 10 opening window 104 opens, connecting the passage between the inside of the catheter 301 and the aorta. Furthermore, the proximal arc segment 202 provides a fulcrum for the distal arc segment 202 to close the opening window 104 during cardiac systole, as it is close to the inner side of the valve body opposite the opening window. Simultaneously, during cardiac diastole, the entire proximal arc segment 201 rests against the proximal end 102 side of the opening window 104. This design allows the proximal arc segment 201 to act as a counterweight while ensuring that the distal arc segment 202, despite its increased area, can respond promptly to changes in blood flow direction, controlling the opening and closing of the bidirectional valve 302 and guiding blood outflow. Simultaneously, the hollow portion 206 of the proximal arc segment 201 does not impede blood flow; instead, it allows for a longer design of the proximal arc segment 201, increasing the lever arm and reducing the force required to rotate the valve disc 20. Therefore, the distal arc segment 202 can be designed to be larger, which in turn allows for a larger opening 104 in the valve body 10, increasing the flow rate of blood pumped by the assisting heart and thus improving the effect of reducing the patient's cardiac workload.Simultaneously, while the proximal arc segment 201 features a hollow section 206, the proximal end 102 of the hollow section 206 has a partially solid blocking area. This blocking area, located near the inner side of the valve body 10 during cardiac systole, is solid and can fall to the opposite side of the opening window 104 due to gravity, providing a fulcrum for the distal arc segment 202. During cardiac diastole, it can block some blood flowing from the distal end 103, causing it to rise towards the opening window 104. Simultaneously, the distal arc segment 202 falls, completing the opening process of the opening window 104. During this stage, the blocking area of ​​the proximal arc segment 201 allows for more timely opening and closing of the bidirectional valve 302. Within this cycle, blood can be pushed into the catheter 301 from the external diaphragm pump 304, but because the valve valve 20 prevents blood from returning to the heart, blood flows out from the opening window 104 of the valve body 10 and into the aorta, generating additional blood flow for the patient and forming one cycle.

[0055] In yet another embodiment, such as Figures 5 to 6The proximal arc segment 201 of the two-way valve 302 has a valve disc hollowed out with a certain area, namely: hollowed-out part 206. In the second state, the part of the proximal arc segment 201 that abuts against the valve body 10 has a certain solid part, but the distal side of the valve disc 20 has a chamfered structure 205 that bends inward toward the valve body 10. The chamfered structure 205 is bent toward the side opposite to the opening window 104, and the side of the chamfered structure 205 facing the opening window 104 is an arc surface or a slope. Specifically, during cardiac systole, blood from the heart enters catheter 301 through the opening 104 of catheter tip 303. At this time, the blood pushes the proximal arc segment 201 of valve 20 away from the solid part on the side of the opening 104, causing the proximal arc segment 201 with the hollow part 206 to press down, and at the same time pushes the distal arc segment 202 closer to the inner surface of valve body 10, so that valve 20 closes the opening 104 of bidirectional valve 302 connecting to the aorta. During this period, blood flows out of the heart and enters catheter 301 through catheter tip 303. During this period, the blood passes through the hollow part 206 of the proximal arc segment 201 to the blood chamber of the external diaphragm pump 304 without obstruction, and the blood is stored in the blood chamber of the external diaphragm pump 304. During the diastolic phase of the heart, the external host 305 pumps the medium into the medium chamber of the external diaphragm pump 304. At this time, the fluid medium gradually fills the chamber, and the diaphragm is also pushed and deformed, pushing the blood in the blood chamber into the catheter 301. The blood flows from the distal end 103 to the proximal end 102. Because the valve disc 20 of the bidirectional valve 302 described in this embodiment has a chamfered structure 205 at the distal arc segment 202, and the valve disc 20 has its own weight, it falls onto the inner surface of the valve body 10 opposite to the opening window 104. The blood flow pushes the proximal arc segment 201 away from the solid segment on the side of the opening window 104, pushing it towards the opening window 104. At this point, the proximal arc segment 201 is in contact with the inner side of the valve body 10 (near the opening window 104); and the distal arc segment 202, due to the blood rushing in from the distal end 103, rotates along its axis with the proximal arc segment 201, causing it to fall and come into contact with the inner surface of the valve body 10 opening window 104, supporting the proximal arc segment 201 and stably blocking blood flow, thus blocking the passage for blood to return to the ventricle. After the valve valve 20 falls, the valve body 10 opening window 104 opens, connecting the passage between the inside of the catheter 301 and the aorta. Blood can be pushed into the catheter 301 from the external diaphragm pump 304, but because the valve valve 20 blocks blood from returning to the heart, blood rushes out from the valve body 10 opening window 104 and flows into the aorta, generating additional blood flow for the patient and forming one cycle. Furthermore, the distal arc segment 202 of the valve disc 2 has a chamfered structure 205, which is located at the end of the distal arc segment 202 away from the proximal arc segment 201. The chamfered structure 205 is inclined relative to the distal arc segment 202, so that a second included angle is formed between the chamfered structure 205 and the distal arc segment 202, and the second included angle is away from the opening window 104.The second included angle ranges from 90° to 165°, meaning that on the side facing the opening window 104, the chamfered structure 205 is inclined at 15° to 90° relative to the centroidal arc segment 202.

[0056] In the technical solution of this embodiment, there is a chamfered structure 205 on one side of the distal end 103 of the distal arc segment 202. During the diastolic phase of the heart, it can respond more quickly to the change in blood flow direction from the distal end 103 to the proximal end 102. During this stage, the chamfered structure 205 of the distal arc segment 202 and the solid blocking area of ​​the proximal arc segment 201 cooperate to make the opening and closing of the bidirectional valve 302 more timely.

[0057] In another embodiment, the second contact area 203 on the distal side of the distal arc segment 202 of the valve disc 20 is a flexible structure. When the valve disc 20 rotates to the first state position, it closes the proximal end 102, as shown in the example. Figure 4 or Figure 6 The state shown in the figure indicates that the distal end 103 is connected to the opening window 104; when the valve disc 20 rotates to the second state position, the opening window 104 is closed by the valve disc 20, as shown in the figure. Figure 2 or Figure 5 In the state shown, the proximal end 102 and the distal end 103 are connected, and there is no obstruction through the hollow portion 206 of the proximal arc segment 201 to the blood chamber of the external diaphragm pump 304. The valve body 10 has a first contact area 105 on its inner wall, located at the edge of the opening window 104 facing the distal end 103. Correspondingly, the valve disc 20 has a second contact area 203 near the distal end 103, corresponding to the first contact area 105, and the second contact area 203 is a flexible structure. When the valve disc 20 rotates to the second state position, the second contact area 203 abuts against the first contact area 105. The flexible structure acts as a buffer, absorbing some of the impact force, making the opening and closing process of the valve disc 20 more stable, and also improving the efficiency and stability of blood delivery.

[0058] Furthermore, both the proximal arc segment 201 and the distal arc segment 202 have the longest length in the axial direction, and the ratio of the axial length of the proximal arc segment 201 to the distal arc segment 202 is within the range of 0.2 to 1.5. In addition, the hollow part 206 occupies a certain area on the proximal arc segment 201, and the ratio of the area of ​​the hollow part 206 to the area of ​​the proximal arc segment 201 is within the range of 0.8 to 2.5.

[0059] In an embodiment of the second aspect of this application, a ventricular assist system is provided, such as Figure 10As 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.

[0060] 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.

[0061] The following describes specific examples of the bidirectional valve and ventricular assist device of this application with reference to the accompanying drawings.

[0062] like Figures 1 to 9 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 valve 20 is divided into a proximal arc segment 201 and a distal arc segment 202, with a thickness of 0.1 to 0.3 mm. The overall outline of the valve 20 can cover the opening window 104 of the valve body 10, ensuring that the valve 20 can completely block the opening window 104 of the valve body 10 during cardiac systole, preventing blood from flowing out. The valve 20 is divided into a proximal arc segment 201 and a distal arc segment 202. The proximal side of the proximal arc segment 201 is fixed to the proximal end 102 of the opening window 104 of the valve body 10 by a pin or other rotatable fixing method. The proximal arc segment 201 and the distal arc segment 202 of the valve 20 are integrally formed. The hollowed-out portion 206 occupies a certain area on the proximal arc segment 201. The ratio of the area of ​​the hollowed-out portion 206 to the area of ​​the proximal arc segment 201 is within the range of 0.8 to 2.5. It can be understood that there are no restrictions on the shape and number of hollowed-out portions 206. Their shape can be elliptical, arc-shaped, circular, or other shapes that can be manufactured. Their number can be one or more. However, there is a limit to the ratio of the total hollowed-out area to the area of ​​the proximal arc segment 201. The ratio range is as shown above.

[0063] In another embodiment, the valve 20 of the distal arc segment 202 has a chamfered structure 205 on the distal side. The chamfered structure 205 has an angle of 15° to 90° and a length of 1.3 to 2.5 times the inner diameter of the valve body 10. This chamfered structure 205 is designed to accommodate the blood flow that pushes back during the diastolic phase of the heart and respond to changes in flow direction by quickly opening the valve body 10 opening window 104 leading to the aorta.

[0064] In another embodiment, the film is made of a polymer material with certain toughness and hardness, such as polyvinyl chloride (PVC) or polyamide (PA). The thickness of the film ranges from 0.3 to 0.5 mm, and the area of ​​the film ranges from 1 to 8 mm². 2 .

[0065] like Figure 2 In the example, coaxial connecting posts are provided on the inner sidewalls of both sides of the valve body 10 in the second direction. The two sides of the valve disc 20 are rotatably connected to the corresponding connecting posts through corresponding connecting holes. Therefore, the centerline of the connecting post is the rotation axis of the valve disc 20. For example, Figures 1 to 9 In the example, in the first direction, the connecting post is located in the middle position inside the valve body 10, and the connecting post is set to correspond to the end of the opening window 104 near the proximal end 102.

[0066] like Figure 10 In the example, the diaphragm pump 304 of the ventricular assist device 30 has a blood chamber for containing blood and a medium chamber for containing a medium. The blood chamber and the medium chamber are separated by a diaphragm that can flexibly deform. The blood chamber is connected to the main tube 301, and the medium chamber is connected to the main unit 305 through a tubing.

[0067] For patients requiring ventricular assist, a puncture can be performed through the femoral artery. A guidewire guides the catheter assembly 301 into the patient's aorta, positioning the distal end window 303 within the left ventricle and the bidirectional valve 302 within the aorta outside the heart. Once the main catheter 301 is filled with blood, it is connected to the external diaphragm pump 304 and the main unit 305. The main unit 305 then pumps blood in accordance with the heart rate to deliver the medium.

[0068] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the 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. The valve disc is rotatably disposed in the valve body and correspondingly disposed in 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 hollow portion with a certain proportion of area on the proximal end side. The valve disc can be connected in a certain way and can rotate relative to the valve body. The valve disc 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, allowing blood to flow through the hollow portion.

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. The hollow portion is located on the proximal arc segment. 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°, 160°).

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 is close to the edge of the proximal end of the opening window, 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 90° to 165°.

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 3mm.

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, Both the proximal arc segment and the distal arc segment have the longest axial length, and the ratio of the axial length of the proximal arc segment to the distal arc segment is in the range of 0.2 to 1.

5.

9. The bidirectional valve according to claim 1, characterized in that, The hollowed-out portion occupies a certain area on the proximal arc segment, and the ratio of the area of ​​the hollowed-out portion to the area of ​​the proximal arc segment is in the range of 0.8 to 2.

5.

10. A ventricular assist system, 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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