Aortic valve simulation device and extracorporeal circulation simulation system

Abstract

An aortic valve simulation device and an extracorporeal circulation simulation system comprise an inlet flange, an artificial valve and an outlet flange, the artificial valve is clamped between the inlet flange and the outlet flange and used for simulating an active valve, and a catheter pump can penetrate into a first flow channel of the inlet flange from the outlet flange. Therefore, the relative position of the catheter pump and the aortic valve is reflected. The artificial valve comprises at least two valve leaflets, and a gap is formed between every two adjacent valve leaflets, so that the valve leaflets on the artificial valve are mutually independent, do not interfere with each other and are easier to open or close; meanwhile, a supporting rod is arranged at one end, facing the artificial valve, of the inner side wall of the inlet flange, the gap can be blocked, and simulation of the one-way valve characteristic of the aortic valve is achieved. According to the aortic valve simulation device, the valve leaflets on the artificial valve are easier to open or close, the trans-valve pressure of the aortic valve simulation device is reduced, the valve opening pressure difference is lower, and the left ventricular pressure and aortic pressure waveforms can be more perfectly reproduced when the cardiovascular state of the human body is simulated when a catheter pump assists.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an aortic valve simulation device and an extracorporeal circulation simulation system. Background Art

[0002] For patients with end-stage heart failure, drug therapy is ineffective, and the most effective treatment is heart transplantation. Since the demand for heart transplantation is far greater than the number of heart donors, most patients with severe heart failure need to endure a long waiting time before heart transplantation, and many patients even lose their precious lives at this stage. In addition, heart failure may also occur as a complication or acute symptom. For example, patients with high-risk coronary artery lesions need to undergo percutaneous coronary intervention. Such patients often have acute heart failure, and symptoms such as myocardial ischemia or arrhythmia may occur during treatment, and there is a risk of malignant hemodynamics. Therefore, cardiac assistance is required to maintain left ventricular function during treatment.

[0003] Among them, cardiogenic shock is an extreme manifestation of heart failure. Severe heart failure can cause acute peripheral circulatory failure. This sudden disease urgently requires a rapid auxiliary device to help heart failure patients restore ventricular function and save their lives. Unlike traditional left ventricular assist devices (LVADs), which have long usage time and low replacement rate, interventional ventricular assist devices (PVADs) have short auxiliary treatment time, are convenient and efficient to implant, have low surgical trauma, and to a certain extent reduce the difficulty and time of doctors' operation during PCI surgery, greatly reducing the surgical risk of heart failure patients. Therefore, interventional treatment of heart failure is also known as the next wave in the field of cardiovascular system intervention.

[0004] After the catheter pump is implanted in the human body, it works together with the heart of the heart failure patient to maintain the normal blood circulation of the human body. Therefore, before actual clinical application, it is necessary to build a pulsating environment that simulates the physical state of heart failure patients to test the performance and operating stability of the catheter pump. Because the catheter pump cannula implanted in the human body is located in a transvalvular position, and the inflow chamber passes through the aortic valve and is located in the left ventricle, based on this, the pulsating test environment needs to build a module that simulates the positional relationship and interaction between the aortic valve and the catheter pump. Generally speaking, mechanical valves are rigid parts and are not suitable for the above application scenarios. The transvalvular pressure difference of the silicone valve is large and cannot accurately reflect the aortic pressure waveform. Although the shape and performance of the biological valve can meet the use requirements, it is expensive, difficult to maintain, and easy to damage, and is not suitable for simulating the aortic valve in a pulsating test environment.

[0005] In summary, various structural modes of the current aortic valve simulation devices have some problems to a greater or lesser extent, and it is difficult to meet the test requirements of the catheter pump in a pulsating environment. Therefore, how to improve the technical defects existing in the prior art has always been a problem that ordinary technicians in this field need to solve. Utility Model Content

[0006] The purpose of the present application is to provide an aortic valve simulation device and an extracorporeal circulation simulation system, which can not only reflect the relative position of the catheter pump and the aortic valve, but also reflect the real waveforms of the left ventricular pressure and the aortic pressure when the catheter pump is assisted.

[0007] The technical solutions provided by this application are as follows:

[0008] An aortic valve simulation device, comprising:

[0009] Inlet flange, prosthetic valve, and outlet flange;

[0010] A first flow channel for fluid to flow in is formed in the inlet flange, a second flow channel for fluid to flow out is formed in the outlet flange, and the artificial valve is clamped between the inlet flange and the outlet flange;

[0011] The artificial valve comprises at least two leaflets, and there is a gap between every two adjacent leaflets; and at least two support rods are provided at one end of the inner side wall of the inlet flange facing the artificial valve, and the support rods can block the gap.

[0012] In some embodiments, the artificial valve further comprises a fixing frame, wherein the fixing frame has an annular structure;

[0013] The leaflet has a leaflet root and a leaflet tip, and the leaflet root portion is connected to the inner side wall of the fixing frame to fix the leaflet to the fixing frame.

[0014] In some embodiments, the artificial valve is made by an integrated molding process, and the artificial valve is configured with a cutting line formed by cutting, wherein the cutting line divides the artificial valve into the fixing frame and the leaflets;

[0015] Wherein, the leaflet root is separated from the fixing frame at two ends in the circumferential direction of the fixing frame.

[0016] In some embodiments, a center plate is further provided at one end of the inlet flange facing the artificial valve;

[0017] The support rod extends in the radial direction of the inlet flange, and one end of the support rod is arranged on the inner side wall of the inlet flange, and the other end is arranged on the center plate, so as to fix the center plate in the first flow channel;

[0018] A through hole is provided on the center plate, and a notch is provided at the tip of the leaflet of the leaflet. The notches of all the leaflets on the artificial valve are together arranged to form a circular hole. The circular hole is coaxially arranged with the through hole and is suitable for a catheter pump to pass through.

[0019] In some embodiments, a sealing ring is provided in the via hole.

[0020] In some embodiments, at least one rib is provided between every two adjacent support rods, and the rib is an arc-shaped plate extending along the circumference of the inlet flange.

[0021] In some embodiments, the cross-sectional dimensions of the support rods are equal everywhere;

[0022] or

[0023] The cross-sectional size of the support rod gradually increases from an end connected to the center plate toward an end connected to the inner side wall of the inlet flange.

[0024] In some embodiments, the connection between the support rod and the inner side wall of the inlet flange adopts an arc transition;

[0025] and / or

[0026] The connection between the support rod and the rib plate adopts arc transition.

[0027] In some embodiments, the outer side wall of one end of the inlet flange facing the artificial valve is provided with a first clamping portion, and the outer side wall of one end of the outlet flange facing the artificial valve is provided with a second clamping portion, and the first clamping portion and the second clamping portion are used to clamp the fixing frame;

[0028] The first clamping part, the second clamping part and the fixing frame are all provided with fastening holes, and fasteners pass through the fastening holes on the first clamping part, the second clamping part and the fixing frame to fix the inlet flange, the artificial valve and the outlet flange.

[0029] The present application also provides an extracorporeal circulation simulation system, comprising the aortic valve simulation device described in any one of the above items.

[0030] The technical effects of this application are:

[0031] 1. In this application, the inlet flange, artificial valve and outlet flange are arranged in sequence, the fluid flows in through the inlet flange, passes through the artificial valve and then flows out through the outlet flange, and the artificial valve is used to simulate the active valve. At this time, the relative position of the catheter pump and the aortic valve can be reflected by inserting the catheter pump from the outlet flange into the first flow channel of the inlet flange. In addition, in this application, there is a gap between each two adjacent leaflets, so that the leaflets on the artificial valve are independent of each other, do not interfere with each other, and are easier to open or close; at the same time, a support rod is provided on one end of the inner wall of the inlet flange facing the artificial valve, which can block the gap and realize the simulation of the "one-way valve" characteristics of the aortic valve. This application reduces the transvalvular pressure of the aortic valve simulation device by making the leaflets on the artificial valve easier to open or close, and the valve opening pressure difference is lower, which can more perfectly reproduce the left ventricular pressure and aortic pressure waveforms when simulating the cardiovascular state of the human body.

[0032] 2. In the present application, both ends of the leaflet root in the circumferential direction of the fixed frame are separated from the fixed frame, and the leaflet is connected to the fixed frame only through the middle part of the leaflet root in the circumferential direction of the fixed frame. Under the premise that the leaflet is not easy to fall off from the fixed frame, it can be opened or closed more easily and quickly under the impact of the fluid, thereby further reducing the transvalvular pressure of the aortic valve simulation device, so that the aortic valve simulation device can more accurately reflect the true waveform of the left ventricular pressure and the aortic pressure when assisted by the catheter pump.

[0033] 3. In the present application, a notch is provided on the tip of the valve leaflet to avoid the catheter pump, so that the valve leaflet will not interfere with the catheter pump during the opening or closing process and will not be easily affected by resistance, thereby making the opening or closing of the valve leaflet easier to achieve. It can also reduce the transvalvular pressure of the aortic valve simulation device to a certain extent, making the valve opening pressure difference lower, thereby more perfectly reproducing the left ventricular pressure and aortic pressure waveforms.

[0034] 4. In the present application, the support rods on the inlet flange extend radially along the inlet flange, and the ribs arranged between two adjacent support rods extend circumferentially along the inlet flange, forming a radial grid structure centered on the center plate. On the one hand, it can ensure that the inlet flange has a larger flow area and a smaller fluid flow resistance, thereby reducing the transvalvular pressure difference when the fluid flows through the aortic valve simulation device; on the other hand, the support rods and ribs are not easy to break under the scouring effect of the fluid, and the structure has good stability, good durability, and strong practicality. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The present application is further described in detail below with reference to the accompanying drawings and specific implementation methods:

[0036] Figure 1 is a plan view of the aortic valve simulation device provided in the embodiment of the present application;

[0037] Figure 2 yes Figure 1 a cross-sectional view of the structure shown;

[0038] Figure 3 yes Figure 1 The structure shown is a plan view as viewed from the outlet flange;

[0039] Figure 4 is a schematic diagram of the three-dimensional structure of an inlet flange provided in an embodiment of the present application;

[0040] Figure 5 is a plan view of an artificial valve provided in an embodiment of the present application;

[0041] Figure 6 yes Figure 4 a plan view of the structure shown;

[0042] Figure 7 is a plan view of an inlet flange provided in another embodiment of the present application;

[0043] Figure 8 4 is a plan view of an inlet flange provided in yet another embodiment of the present application.

[0044] Description of Figure Numbers:

[0045] 100, inlet flange; 110, first flow channel; 120, support rod; 130, center plate; 131, through hole; 140, rib plate; 150, first clamping part;

[0046] 200, artificial valve; 210, leaflet; 211, leaflet root; 212, leaflet tip; 220, gap; 230, fixing frame; 240, cutting line; 250, circular hole;

[0047] 300, outlet flange; 310, second flow channel; 320, second clamping portion;

[0048] 401. Fastening holes. DETAILED DESCRIPTION

[0049] In the following description, specific details such as specific system structures, technologies, etc. are provided for the purpose of illustration rather than limitation, so as to provide a thorough understanding of the embodiments of the present application. However, it should be clear to those skilled in the art that the present application may also be implemented in other embodiments without these specific details. In other cases, detailed descriptions of well-known systems, devices, circuits, and methods are omitted to prevent unnecessary details from obstructing the description of the present application.

[0050] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the specific implementation methods of the present application will be described below with reference to the accompanying drawings. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings and other implementation methods can be obtained based on these drawings without creative work.

[0051] In order to simplify the drawings, only the parts related to the present application are schematically shown in each figure, and they do not represent the actual structure of the product. In addition, in order to simplify the drawings and facilitate understanding, in some figures, only one of the parts with the same structure or function is schematically drawn or marked.

[0052] In this document, it should be noted that, unless otherwise clearly specified and limited, the term "connection" should be understood in a broad sense, for example, it can be a fixed connection, or a detachable connection, or an integral connection; or it can be a mechanical connection, or it can be an electrical connection; or it can be a direct connection, or it can be indirectly connected through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0053] In the embodiments shown in the drawings, directional indications (such as up, down, left, right, front, and back, etc.) are not absolute but relative when describing the structure and movement of each component, and are not used to limit the direction of the product in actual use.

[0054] In addition, in the description of the present application, ordinal numbers, such as "first", "second", etc., are only used to distinguish and describe related objects, and cannot be understood as indicating or implying the relative importance or order between the related objects.

[0055] As an interventional ventricular assist device, the catheter pump works with the heart of the heart failure patient to maintain normal blood circulation after being implanted in the human body. Therefore, before actual clinical application, it is necessary to build a pulsating environment that simulates the physical state of heart failure patients to test the performance and operating stability of the catheter pump.

[0056] Generally speaking, mechanical valves are rigid and cannot simulate the softness of the human aortic valve, so they are not suitable for the above application scenarios; and the transvalvular pressure difference of silicone valves is large and cannot accurately reflect the aortic pressure waveform. Although the shape and performance of biological valves can meet the simulation requirements of the human aortic valve, they are expensive, difficult to maintain, and easy to damage, making them unsuitable for simulating the aortic valve in a pulsating test environment.

[0057] In this regard, the present application provides an aortic valve simulation device, the valve on which can not only simulate the human aortic valve, reflect the relative position of the catheter pump and the aortic valve, but also reflect the true waveform of the left ventricular pressure and aortic pressure when the catheter pump is assisted.

[0058] For example, see Figures 1 to 5 An aortic valve simulation device includes an inlet flange 100, an artificial valve 200 and an outlet flange 300. The inlet flange 100 is connected to a left ventricle simulation device, the outlet flange 300 is connected to an aortic simulation device, and the artificial valve 200 is sandwiched between the inlet flange 100 and the outlet flange 300 to simulate the human aortic valve. A first flow channel 110 for fluid inflow is formed in the inlet flange 100, and a second flow channel 310 for fluid outflow is formed in the outlet flange 300. A catheter pump can be inserted from the outlet flange 300 into the first flow channel 110 of the inlet flange 100 to reflect the relative position of the catheter pump and the aortic valve. The artificial valve 200 includes at least two leaflets 210, and there is a gap 220 between each two adjacent leaflets 210. By setting the gap 220, the leaflets 210 on the artificial valve 200 can be independent of each other and do not interfere with each other, making it easier to open or close; at the same time, a support rod 120 is provided on one end of the inner wall of the inlet flange 100 facing the artificial valve 200 to block the gap 220.

[0059] Specifically, when the fluid pressure of the left ventricle simulation device is greater than the fluid pressure of the aorta simulation device, the fluid flows into the first flow channel 110 of the inlet flange 100, and under the driving effect of the fluid, the leaflets 210 on the artificial valve 200 will open, and the fluid will flow through the artificial valve 200 to the second flow channel 310 of the outlet flange 300. At this time, the fluid will continue to flow through the aortic valve simulation device until the fluid pressure of the left ventricle simulation device is lower than the fluid pressure of the aorta simulation device. When the fluid pressure of the left ventricle simulation device is lower than the fluid pressure of the aorta simulation device, under the effect of the pressure difference, the leaflets 210 on the artificial valve 200 will close and gather toward the side where the inlet flange 100 is located. At this time, due to the blocking effect of the support rod 120, the leaflets 210 will fit on the support rod 120, and the gaps 220 between the leaflets 210 on the artificial valve 200 can also be covered by the support rod 120. In this way, the fluid flow path (the first flow channel 110 and the second flow channel 310) of the aortic valve simulation device will be completely closed and blocked. Even if there is a pressure difference, the fluid cannot flow back from the outlet flange 300 to the inlet flange 100, thereby realizing the simulation of the "one-way valve" characteristics of the human aortic valve.

[0060] Under the action of pressure difference, the leaflets 210 on the aortic valve simulation device provided in this embodiment will open and close periodically, simulating the motion state of the aortic valve more realistically. In addition, this embodiment reduces the transvalvular pressure of the aortic valve simulation device by making the leaflets 210 on the artificial valve 200 easier to open or close, and the valve opening pressure difference is lower, so that the aortic valve simulation device can more perfectly reproduce the left ventricular pressure and aortic pressure waveforms when simulating the cardiovascular state of the human body.

[0061] The outer diameter of the outlet flange 300 is similar to the diameter of the human artery, usually 23-35 mm, and the artificial valve 200 is made of soft rubber with a thickness of about 1 mm, which can simulate the soft characteristics of the human aortic valve.

[0062] Since the leaflet 210 is made of a soft material and is easier to open and close, the transvalvular pressure difference of the aortic valve simulator can be further reduced to a certain extent, making the left ventricular pressure and aortic pressure waveforms reflected by the aortic valve simulator during the simulation process more realistic and reliable.

[0063] As a preference, see Figure 3 and Figure 5 The number of leaflets 210 on the artificial valve 200 is 3, which can simulate the normal human aortic valve morphology. In contrast, the number of support rods 120 on the inlet flange 100 should be a multiple of 3, such as 3, 6, 9, etc., to ensure that the gaps 220 between the three leaflets 210 can be completely covered by the support rods 120 on the inlet flange 100.

[0064] Of course, in actual production, the number of leaflets 210 can also be 2 or 4. At the same time, the number of support rods 120 can correspond to multiples of 2 or 4. They are not elaborated here one by one and are all within the protection scope of this application.

[0065] Further, see Figure 4 The end of the inlet flange 100 facing the artificial valve 200 is also provided with a center plate 130, and the support rod 120 extends along the radial direction of the inlet flange 100, and one end of the support rod 120 is fixed to the inner wall of the inlet flange 100, and the other end of the support rod 120 is connected to the edge of the center plate 130, so as to fix the center plate 130 in the first flow channel 110. Among them, the center plate 130 is provided with a through hole 131, and the through hole 131 can be passed through by the catheter pump, and the catheter pump is fixed at the center position of the inlet flange 100 to reflect the relative position of the catheter pump and the aortic valve, so as to facilitate the aortic valve simulation device to reflect the real waveforms of the left ventricular pressure and the aortic pressure when the catheter pump is assisted.

[0066] In a specific embodiment, the inner diameter of the through hole 131 on the center plate 130 is consistent with the maximum outer diameter of the catheter pump, so that the catheter pump can be clamped on the center plate 130, so that the catheter pump is fixed at the center position of the inlet flange 100. Alternatively, a sealing ring can be arranged in the through hole 131 on the center plate 130, and the inner diameter of the sealing ring is smaller than the maximum outer diameter of the catheter pump, so that the catheter pump can be clamped on the center plate 130 and play a sealing role at the same time, and no further restrictions are made here, and all are within the protection scope of the present application.

[0067] Preferably, see Figure 5 The leaflet 210 has a leaflet root 211 and a leaflet tip 212, and a notch is provided on the leaflet tip 212, and the gap 220 between each two adjacent leaflets 210 is preferably in a fan-shaped structure, so that the notches of all the leaflets 210 on the artificial valve 200 can be jointly surrounded to form a circular hole 250, and the circular hole 250 is coaxially arranged with the through hole 131 on the center plate 130, which can avoid the catheter pump, so that the leaflet 210 will not interfere with the catheter pump during the opening or closing process, and is not easily affected by resistance, thereby making it easier to open or close the leaflet 210, further reducing the transvalvular pressure of the aortic valve simulation device, making the valve opening pressure difference lower, thereby more perfectly reproducing the left ventricular pressure and aortic pressure waveforms.

[0068] Among them, the diameter of the circular hole 250 can be consistent with the maximum outer diameter of the catheter pump; or, the diameter of the circular hole 250 is slightly larger than the maximum outer diameter of the catheter pump and smaller than the outer contour size of the center plate 130, which can further avoid interference between the leaflet 210 and the catheter pump, and at the same time, will not affect the "one-way valve" characteristics of the artificial valve 200.

[0069] Further, see Figure 4 At least one rib plate 140 is provided between each two adjacent support rods 120, and the rib plate 140 is an arc-shaped plate extending along the circumference of the inlet flange 100, forming a radial grid structure centered on the center plate 130, and the fluid can flow through the grid structure. On the one hand, the support rod 120 and the rib plate 140 cooperate with each other, and when the fluid pressure of the left ventricle simulation device is lower than the fluid pressure of the aorta simulation device, the valve leaf 210 can be blocked together, so that the valve leaf 210 fits on the grid formed by the support rod 120 and the rib plate 140, and is less likely to be flushed open by the fluid under the action of the pressure difference, and the artificial valve 200 can more perfectly simulate the "one-way valve" characteristics of the human aortic valve. On the other hand, the provision of the rib plate 140 can improve the structural strength and anti-fluid scouring ability of the support plate to a certain extent, reduce the risk of the support rod 120 breaking under the scouring action of the fluid, and make the aortic valve simulation device have good structural stability, good durability, and strong practicality.

[0070] Specifically, see Figure 4 The support rods 120 on the inlet flange 100 are evenly spaced along the circumference of the inlet flange 100, and a rib plate 140 is arranged between every two adjacent support rods 120. The rib plates 140 on the inlet flange 100 together form an annular structure. The annular structure formed by the rib plates 140, the center plate 130, and the through holes 131 on the center plate 130 are all coaxially arranged.

[0071] Further, see Figure 7 The connection between the support rod 120 and the inner wall of the inlet flange 100 and / or the connection between the support rod 120 and the rib 140 adopts an arc transition, which can reduce the erosion of the fluid on the connection between the support rod 120 and the inner wall of the inlet flange 100 and / or the connection between the support rod 120 and the rib 140, reduce the wear of the support rod 120 and the rib 140, and further improve the durability of the aortic valve simulation device.

[0072] In one example embodiment, see Figure 5 The artificial valve 200 further includes a fixing frame 230, which is annular in structure. At this time, the leaflet root 211 is only partially connected to the inner wall of the fixing frame 230 to fix the leaflet 210 to the fixing frame 230. Specifically, the artificial valve 200 is made by an integrated molding process, and the artificial valve 200 is configured with a cutting line 240 formed by cutting, which divides the artificial valve 200 into the above-mentioned fixing frame 230 and the leaflet 210, and the leaflet root 211 is separated from the fixing frame 230 after cutting at both ends of the fixing frame 230 in the circumferential direction.

[0073] Among them, the width of the leaflet root 211 in the circumferential direction of the fixed frame 230 is 3-10mm. In this embodiment, the leaflet 210 is connected to the fixed frame 230 only through the middle part of the leaflet root 211 in the circumferential direction of the fixed frame 230. Under the premise of ensuring that the leaflet 210 is not easy to fall off from the fixed frame 230, it can be opened or closed more easily and quickly under the impact of the fluid, further reducing the transvalvular pressure of the aortic valve simulation device, so that the aortic valve simulation device can more accurately reflect the real waveform of the left ventricular pressure and the aortic pressure when assisted by the catheter pump.

[0074] In a specific embodiment, see Figure 4 and Figure 6 There are 9 support rods 120 on the inlet flange 100, and the cross-sectional size of each support rod 120 gradually increases from the end connected to the center plate 130 toward the end connected to the inner wall of the inlet flange 100. The structural stability is high enough and has good durability. It is suitable for the construction of extracorporeal circulation pipelines and the measurement of hemodynamic performance of interventional catheter pumps.

[0075] Or, in a specific embodiment, see Figure 7 The number of support rods 120 on the inlet flange 100 is 3, and the cross-sectional size of each support rod 120 gradually increases from the end connected to the center plate 130 toward the end connected to the inner wall of the inlet flange 100 .

[0076] In this embodiment, the support rods 120 on the inlet flange 100 are fewer in number and thinner in width than in the previous specific embodiment, so that the grid-like structure on the inlet flange 100 is smaller in volume, which helps to increase the flow area of ​​the inlet flange 100 and reduce flow resistance, thereby further reducing the trans-valvular pressure difference when the fluid flows through the aortic valve simulation device, so that the aortic valve simulation device can more accurately reflect the true waveform of the left ventricular pressure and the aortic pressure when assisted by the catheter pump.

[0077] Or, in a specific embodiment, see Figure 8 , the number of support rods 120 on the inlet flange 100 is 3 or 6, and the cross-sectional dimensions of each support rod 120 are all equal, presenting a thin rod structure with equal diameter in the radial direction of the inlet flange 100. Compared with the previous two specific embodiments, the structural arrangement of the support rod 120 of this embodiment ensures that the inlet flange 100 can have a larger flow area, small flow resistance, less pressure drop (that is, energy change, that is, pressure drop caused by energy loss when the fluid flows in the pipe), and no stress concentration exists, and the support rod 120 is less likely to break during operation and has good stability.

[0078] Specifically, see Figures 2 to 5 The outer wall of one end of the inlet flange 100 facing the artificial valve 200 is provided with a first clamping portion 150, and the outer wall of one end of the outlet flange 300 facing the artificial valve 200 is provided with a second clamping portion 320 (the outer diameter of the outlet flange 300 in the foregoing text is similar to the diameter of the human artery, excluding the outer diameter of the second clamping portion 320, which is the outer diameter of the outlet flange 300 after removing the second clamping portion 320). The first clamping portion 150 and the second clamping portion 320 are used to clamp the fixed frame 230. The first clamping portion 150, the second clamping portion 320 and the fixed frame 230 are all provided with fastening holes 401, and the fasteners pass through the fastening holes 401 on the first clamping portion 150, the second clamping portion 320 and the fixed frame 230 to fix the inlet flange 100, the artificial valve 200 and the outlet flange 300.

[0079] In actual use, the fastening holes 401 on the inlet flange 100, the fastening holes 401 on the artificial valve 200, and the fastening holes 401 on the outlet flange 300 can be aligned first, and then fixed by screws to complete the assembly of the aortic valve simulation device. Among them, in addition to screws, the fasteners can also be bolts, screws, rivets, etc., which are not described in detail here and are all within the scope of protection of this application. Then, the catheter pump is inserted from one side of the outlet flange 300, through the circular hole 250 on the artificial valve 200 and the through hole 131 on the center plate 130, and penetrated into the first flow channel 110 of the inlet flange 100.

[0080] Since the catheter pump is fixed in the through hole 131 on the center plate 130, the leaflet 210 avoids the position of the catheter pump, thereby eliminating the interference of the leaflet 210 with the catheter pump when opening and closing. Moreover, since the material of the leaflet 210 is soft, it is easier to open and close the leaflet 210, that is, the transvalvular pressure of the aortic valve simulation device is reduced, and the valve opening pressure difference is low, so the left ventricular pressure and aortic pressure waveforms can be perfectly reproduced when simulating the cardiovascular state of the human body.

[0081] The aortic valve simulation device provided by the present application not only simulates the characteristics of the human aortic valve, but is also applicable to the special test scenarios of the interventional catheter pump. Moreover, the inlet flange 100, the artificial valve 200 and the outlet flange 300 in the aortic valve simulation device provided by the present application have the characteristics of simple structure, simple process, low cost, good stability and durability, and can be widely used in the construction of extracorporeal circulation pipelines and the measurement of the hemodynamic performance of interventional catheter pumps, and are highly practical.

[0082] The present application also provides an extracorporeal circulation simulation system, comprising the aortic valve simulation device provided in any of the above embodiments.

[0083] In the above embodiments, the description of each embodiment has its own emphasis. For parts that are not described or recorded in detail in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.

[0084] It should be noted that the above embodiments can be freely combined as needed. The above are only preferred implementations of the present application. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application, and these improvements and modifications should also be regarded as the protection scope of the present application.

Claims

1. An aortic valve simulation device, It is characterized in that include: Inlet flange, prosthetic valve, and outlet flange; A first flow channel for fluid to flow in is formed in the inlet flange, a second flow channel for fluid to flow out is formed in the outlet flange, and the artificial valve is clamped between the inlet flange and the outlet flange; The artificial valve comprises at least two leaflets, and there is a gap between every two adjacent leaflets; and at least two support rods are provided at one end of the inner side wall of the inlet flange facing the artificial valve, and the support rods can block the gap.

2. The aortic valve simulation device according to claim 1, It is characterized in that The artificial valve further comprises a fixing frame, and the fixing frame is in an annular structure; The leaflet has a leaflet root and a leaflet tip, and the leaflet root portion is connected to the inner side wall of the fixing frame to fix the leaflet to the fixing frame.

3. The aortic valve simulation device according to claim 2, It is characterized in that The artificial valve is made by an integrated molding process, and the artificial valve is provided with a cutting line formed by cutting, wherein the cutting line divides the artificial valve into the fixing frame and the valve leaflets; Wherein, the leaflet root is separated from the fixing frame at two ends in the circumferential direction of the fixing frame.

4. The aortic valve simulation device according to claim 1, It is characterized in that The end of the inlet flange facing the artificial valve is also provided with a center plate; The support rod extends in the radial direction of the inlet flange, and one end of the support rod is arranged on the inner side wall of the inlet flange, and the other end is arranged on the center plate, so as to fix the center plate in the first flow channel; A through hole is provided on the center plate, and a notch is provided at the tip of the leaflet of the leaflet. The notches of all the leaflets on the artificial valve are together arranged to form a circular hole. The circular hole is coaxially arranged with the through hole and is suitable for a catheter pump to pass through.

5. The aortic valve simulation device according to claim 4, It is characterized in that A sealing ring is arranged in the via hole.

6. The aortic valve simulation device according to claim 4, It is characterized in that At least one rib is provided between each two adjacent support rods, and the rib is an arc-shaped plate extending along the circumference of the inlet flange.

7. The aortic valve simulation device according to claim 4, It is characterized in that The cross-sectional dimensions of the support rods are equal everywhere; or The cross-sectional size of the support rod gradually increases from an end connected to the center plate toward an end connected to the inner side wall of the inlet flange.

8. The aortic valve simulation device according to claim 6, It is characterized in that The connection between the support rod and the inner wall of the inlet flange adopts an arc transition; and / or The connection between the support rod and the rib plate adopts arc transition.

9. The aortic valve simulation device according to claim 2 or 3, It is characterized in that The outer side wall of one end of the inlet flange facing the artificial valve is provided with a first clamping portion, and the outer side wall of one end of the outlet flange facing the artificial valve is provided with a second clamping portion, and the first clamping portion and the second clamping portion are used to clamp the fixing frame; The first clamping part, the second clamping part and the fixing frame are all provided with fastening holes, and fasteners pass through the fastening holes on the first clamping part, the second clamping part and the fixing frame to fix the inlet flange, the artificial valve and the outlet flange.

10. An extracorporeal circulation simulation system, It is characterized in that The invention comprises the aortic valve simulation device as described in any one of claims 1 to 9.

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