Artificial valve shaping treatment device and shaping treatment method

Abstract

The invention relates to an artificial valve shaping treatment device which is characterized in that a liquid supply pipe is mounted on a peristaltic pump, the liquid inlet end of the liquid supply pipe is connected with a lower container, and the liquid outlet end of the liquid supply pipe is connected with an upper container; shaping liquid is arranged in the upper container and the lower container; the artificial valve loading assembly is arranged in the lower container and immersed by the shaping liquid in the lower container, the top of the artificial valve loading assembly is communicated with the lower container, an artificial valve is loaded in the artificial valve loading assembly, one end of the shaping pipe is connected with the bottom of the upper container, and the other end of the shaping pipe is connected with the lower container. The other end of the shaping tube is connected with the bottom of the artificial valve loading assembly; the opening direction of valve leaflets of the artificial valve faces the bottom of the artificial valve loading assembly, so that the artificial valve is reversely loaded in the artificial valve loading assembly. The valve shape is closer to the natural state of the human body, the opening and closing effect of the valve is better, the fluid mechanical property is better, and the valve is greatly beneficial to doctors and patients. The invention further provides an artificial valve shaping treatment method.

Description

Technical Field

[0001] This patent relates to the field of medical device technology, and specifically, to an artificial valve shaping processing device and shaping processing method. Background Art

[0002] Valve replacement surgery is to replace the patient's diseased valve by implanting an artificial valve. Under normal circumstances, the leaflets of a normal heart valve are open when blood flows in the forward direction, and they should be completely closed when blood flows in the reverse direction, so as to effectively block the backflow of blood. Based on this, the artificial valve implanted in valve replacement surgery is required to have the same function as the normal valve of the human body, that is, it should also be completely closed when subjected to reverse pressure from blood.

[0003] The leaflets of artificial valves are sutured by hand. After suturing, the leaflets lack a pocket-shaped structure, and the morphological structure may be irregular and unstable, and the coaptation effect is poor, which affects the function and fluid dynamics of the valve. To solve the above problems, after the valve is sutured, a special shaping device is used to shape the valve, optimize the leaflet morphology, enhance the valve structure, improve the valve opening and closing effect, and improve the fluid dynamics of the valve, thereby extending the clinical service life of the valve. Summary of the invention

[0004] The purpose of this patent is to provide an artificial valve shaping processing device and shaping processing method to overcome the above-mentioned existing defects.

[0005] In order to achieve the above-mentioned purpose of this patent, the following technical solutions are adopted:

[0006] In a first aspect, the present application provides an artificial valve shaping processing device, comprising a peristaltic pump, a liquid supply tube, an upper container, a lower container, an artificial valve loading component and a shaping tube;

[0007] The liquid supply pipe is installed on the peristaltic pump, the liquid inlet end of the liquid supply pipe is connected to the lower container, and the liquid outlet end of the liquid supply pipe is connected to the upper container;

[0008] The upper container and the lower container are both provided with setting liquid;

[0009] The artificial valve loading assembly is arranged in the lower container, the artificial valve loading assembly is immersed in the shaping liquid in the lower container, the top of the artificial valve loading assembly is connected to the lower container, the artificial valve is loaded in the artificial valve loading assembly, one end of the shaping tube is connected to the bottom of the upper container, and the other end of the shaping tube is connected to the bottom of the artificial valve loading assembly;

[0010] The opening direction of the leaflets of the artificial valve is set toward the bottom of the artificial valve loading component so that the flow direction of the setting liquid flowing through the artificial valve is opposite to the opening direction of the leaflets, thereby allowing the artificial valve to be reversely loaded in the artificial valve loading component.

[0011] Further, the artificial valve loading assembly includes a valve loading tube, a hollow plug, and a valve loading tube quick-connect connector;

[0012] The valve loading tube is vertically arranged in the lower container, the valve loading tube is loaded with an artificial valve, the hollow plug is located at the top of the valve loading tube, and the valve loading tube quick connector is located at the bottom of the valve loading tube;

[0013] The other end of the shaping tube is connected to the valve loading tube quick-connect joint.

[0014] Furthermore, the valve loading tube and the artificial valve are assembled together by interference fit to fix the artificial valve;

[0015] The hollow plug is assembled with the valve inflow end of the artificial valve in an interference fit manner to fix the valve inflow end.

[0016] Further, the valve loading tube quick connector is connected to the valve loading tube via an O-ring, or the valve loading tube quick connector is directly connected to the valve loading tube via an interference fit.

[0017] Furthermore, it also includes a mounting bracket, the mounting bracket is arranged in the lower container, the artificial valve loading assembly is installed on the mounting bracket, and the mounting bracket is provided with through holes at positions corresponding to the valve loading tube quick-connect joints of each artificial valve loading assembly;

[0018] The mounting bracket is a height-adjustable bracket;

[0019] The shaping tube is arranged on the inner side of the lower container and is connected with the quick-connect connector.

[0020] Furthermore, the valve loading tube quick-connect connector of each artificial valve loading assembly is exposed outside through the bottom of the lower container;

[0021] The shaping tube is arranged on the outside of the lower container and is connected to the quick-connect joint of the valve loading tube which is exposed outside.

[0022] Furthermore, a flow regulating switch is provided on the shaping tube.

[0023] Furthermore, it also includes an upper container drainage pipe, one end of which is connected to the side wall of the upper container through a pipeline quick-connect joint, and the other end of the upper container drainage pipe is connected to the lower container.

[0024] In a second aspect, the present application further provides an artificial valve shaping processing method using the artificial valve shaping processing device, comprising the following steps:

[0025] Step S10: reversely loading the artificial valve into the artificial valve loading assembly;

[0026] Step S20: Turn on the flow regulating switch on the shaping tube, and the shaping liquid in the upper container enters the interior of the artificial valve loading component from the bottom of the artificial valve loading component through the shaping tube. The shaping liquid in the upper container flows through the artificial valve from bottom to top, exerting an upward reverse pressure F on the leaflet. 瓣叶， Keep the valve leaflets closed;

[0027] Step S30: turning on the peristaltic pump to pump the setting liquid in the lower container into the upper container, and the setting liquid in the upper container flows into the lower container through the setting pipe and the upper container drain pipe; controlling the flow rate of the peristaltic pump to stabilize the liquid levels of the setting liquid in the upper container and the lower container to form a dynamic balance;

[0028] Step S40: The height difference Δh between the liquid levels in the upper container and the lower container is the reverse pressure applied to the leaflet during the shaping process; the magnitude of the reverse pressure applied to the leaflet can be adjusted by adjusting the value of Δh, so that the leaflet shaping can achieve the desired effect;

[0029] Step S50: The shaping liquid chemically modifies the closed leaflets for a certain period of time to complete shaping of the leaflets.

[0030] Furthermore, the reverse pressure F exerted on the leaflet is 瓣叶 =ρgsΔh, where ρ is the density of the setting liquid; g is the acceleration due to gravity; s is the cross-sectional area after the leaflet is closed; and Δh is the height difference between the liquid levels in the upper container and the lower container.

[0031] Furthermore, in step S10, reverse loading the artificial valve into the artificial valve loading component means that the opening direction of the leaflets of the artificial valve is set toward the bottom of the artificial valve loading component so that the flow direction of the shaping liquid flowing through the artificial valve is opposite to the opening direction of the leaflets.

[0032] Furthermore, the reverse pressure value required for leaflet shaping can be determined according to the usage scenario of the artificial valve.

[0033] By adopting the above technical solution, this patent has the following beneficial effects:

[0034] The artificial valve shaping processing device of the present application is, before starting shaping, a liquid supply tube is installed on a peristaltic pump, the liquid inlet end of the liquid supply tube is connected to a lower container, and the liquid outlet end of the liquid supply tube is connected to an upper container; both the upper container and the lower container are filled with shaping liquid, the artificial valve is reversely loaded into the artificial valve loading component, so that the opening direction of the valve leaflets is set toward the bottom of the artificial valve loading component, the artificial valve loading component is set in the lower container, one end of the shaping tube is connected to the bottom of the upper container, and the other end of the shaping tube is connected to the bottom of the artificial valve loading component, the shaping liquid in the upper container enters the artificial valve loading component from the bottom of the artificial valve loading component through the shaping tube, the shaping liquid in the shaping tube flows through the artificial valve in a bottom-up manner, and applies an upward reverse pressure to the valve leaflets, so that the valve leaflets are in a closed state, the shaping liquid chemically modifies the closed valve leaflets, and completes the shaping of the valve leaflets.

[0035] The shaping liquid in the upper container passes through the shaping tube and flows through the artificial valve from bottom to top. The flow of the shaping liquid in the shaping tube is smoother and more controllable, which helps to save debugging time and quickly achieve balance between the downward liquid pressure on the leaflets and the upward liquid pressure on the leaflets.

[0036] The artificial valve shaping processing device of the present application can close the leaflets under the action of liquid reverse pressure, and the shaping liquid chemically modifies the leaflets in the closed state to shape the leaflets.

[0037] The back pressure shaped leaflets form a pocket-like structure, and the depth of the base of each leaflet is increased, which is closer to the shape of the human body's own valve. One of the functions of the pocket-like structure is that when the leaflet is closed, it can buffer the pressure generated by the reverse flow of blood and increase the service life of the artificial valve; in addition, it can also reduce the vortex generated by the blood and reduce the risk of thrombosis.

[0038] The free edge curvature of each leaflet becomes longer after back pressure shaping, and the junction of the three leaflets, i.e., the leaflet junction, becomes smaller; the leaflets are flatter, and their size and structure are more stable; the relative positions of the leaflets are more stable and consistent, the valve opening and closing effects are better, and the degree of regurgitation is lower, which makes the artificial valve have better hemodynamic characteristics.

[0039] The artificial valve shaping processing device of the present application can effectively reduce the leaflet wrinkles, poor consistency of leaflet coaptation, unstable morphological structure and other phenomena existing in existing artificial valves. The shaping process is simple to operate, has good product consistency, high efficiency, and a more stable structure. It is closer to the natural state of the human body, making the valve opening and closing effect better, the fluid mechanics performance better, and the long-term effect of clinical application better, which is of great benefit to doctors and patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] In order to more clearly illustrate the specific implementation methods of this patent or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of this patent. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0041] Figure 1 This is a schematic structural diagram of the first artificial valve shaping and processing device of the present application;

[0042] Figure 2 for Figure 1 A partial enlarged view of the middle A;

[0043] Figure 3 This is a schematic structural diagram of the artificial valve loading assembly of the present application;

[0044] Figure 4 A schematic diagram of the structure of the artificial valve of the present application;

[0045] Figure 5 This is a schematic diagram showing that the opening direction of the valve leaflet of the present application is opposite to the flow direction of the setting liquid in the upper container of the artificial valve;

[0046] Figure 6 This is a schematic structural diagram of a first artificial valve shaping processing device of the present application, in which the artificial valve loading assembly is provided in plurality;

[0047] Figure 7 This is a schematic structural diagram of a mounting bracket in the first artificial valve shaping and processing device of the present application;

[0048] Figure 8 This is a schematic structural diagram of multiple artificial valve loading components on a mounting bracket in the first artificial valve shaping processing device of the present application;

[0049] Fig. 9 for Figure 6 A partial enlarged view of point B in the middle;

[0050] Fig.10 This is a schematic structural diagram of a second artificial valve shaping and processing device of the present application;

[0051] Fig.11 for Fig.10 A partial enlarged view of point C in the middle;

[0052] Fig.12 This is a schematic diagram of the structure of the pipeline quick-connect connector of this application;

[0053] Fig.13Schematic diagram of the height difference Δh of the liquid levels in the upper container and the lower container of the present application;

[0054] Fig.14 This is a schematic diagram of the morphology of the pocket-like structure on the leaflet of a human autologous valve;

[0055] Fig.15 Schematic diagram of the morphology and blood flow direction of a normally functioning valve.

[0056] Fig.16 A schematic flow chart of the artificial valve shaping method provided in Example 3 of the present application.

[0057] Figure markings: 1-peristaltic pump; 2-liquid supply pipe; 3-upper container; 4-pipeline quick connector; 5-forming tube; 6-flow regulating switch; 7-upper container discharge pipe; 8-lower container; 9-valve loading tube; 10-valve loading tube quick connector; 17-sealing screw washer; 11-hollow plug; 111-plug hole; 12-O-ring; 13-mounting bracket; 16-support frame; 20-artificial valve loading assembly; 30-artificial valve; 31-leaflet; 32-pocket-shaped structure; 161-support rod; 162-upper support plate; 163-lower support plate. DETAILED DESCRIPTION

[0058] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0059] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0060] like Figure 1-Figure 15 As shown, the artificial valve shaping processing device of the present application includes a peristaltic pump 1, a liquid supply tube 2, an upper container 3, a lower container 8, an artificial valve loading component 20 and a shaping tube 5;

[0061] The liquid supply pipe 2 is installed on the peristaltic pump 1, the liquid inlet end of the liquid supply pipe 2 is connected to the lower container 8, and the liquid outlet end of the liquid supply pipe 2 is connected to the upper container 3;

[0062] The upper container 3 and the lower container 8 are both filled with setting liquid;

[0063] The artificial valve loading assembly 20 is arranged in the lower container 8, the artificial valve loading assembly 20 is immersed in the shaping liquid in the lower container 8, the top of the artificial valve loading assembly 20 is connected to the lower container 8, the artificial valve 30 is loaded in the artificial valve loading assembly 20, one end of the shaping tube 5 is connected to the bottom of the upper container 3, and the other end of the shaping tube 5 is connected to the bottom of the artificial valve loading assembly 20;

[0064] The opening direction of the leaflets 31 of the artificial valve 30 is set toward the bottom of the artificial valve loading component 20, so that the flow direction of the molding liquid flowing through the artificial valve 30 is opposite to the opening direction of the leaflets 31, thereby allowing the artificial valve 30 to be reversely loaded in the artificial valve loading component 20.

[0065] The artificial valve shaping processing device of the present application, before starting shaping, installs the liquid supply tube 2 on the peristaltic pump 1, the liquid inlet end of the liquid supply tube 2 is connected to the lower container 8, and the liquid outlet end of the liquid supply tube 2 is connected to the upper container 3;

[0066] The upper container 3 and the lower container 8 are both filled with setting liquid. The artificial valve 30 is reversely loaded into the artificial valve loading assembly 20, so that the opening direction of the valve leaflets 31 is set toward the bottom of the artificial valve loading assembly 20. The artificial valve loading assembly 20 is set in the lower container 8. Since the top of the artificial valve loading assembly 20 is connected to the lower container 8, the setting liquid in the lower container 8 can enter the interior of the artificial valve loading assembly 20 and apply a downward liquid pressure to the valve leaflets 31.

[0067] One end of the shaping tube 5 is connected to the bottom of the upper container 3, and the other end of the shaping tube 5 is connected to the bottom of the artificial valve loading assembly 20. The shaping liquid in the upper container 3 enters the artificial valve loading assembly 20 from the bottom of the artificial valve loading assembly 20 through the shaping tube 5. The shaping liquid in the shaping tube 5 flows through the artificial valve 30 from bottom to top and applies an upward liquid pressure to the valve leaflet 31.

[0068] Since there is a height difference between the liquid levels of the shaping liquid in the upper container 3 and the shaping liquid in the lower container 8, the upward liquid pressure on the leaflet 31 is greater than the downward liquid pressure on the leaflet 31, and since the opening direction of the leaflet 31 is opposite to the flow direction of the shaping liquid in the upper container 3 flowing through the artificial valve 30, the leaflet 31 is subjected to a reverse liquid pressure opposite to the opening direction of the leaflet 31. Under the action of this reverse liquid pressure, the leaflet 31 can be in a closed state, and the shaping liquid chemically modifies the leaflet 31 in the closed state to shape the leaflet 31.

[0069] During the shaping process of the leaflet 31, the internal space of the artificial valve 30 at the valve inlet end is filled with the shaping liquid in the lower container 8, and the internal space of the artificial valve 30 at the valve outlet end is filled with the shaping liquid in the upper container 3, so the artificial valve 30 will not be deformed.

[0070] The shaping liquid in the upper container 3 passes through the shaping tube 5 and flows through the artificial valve 30 from bottom to top. The flow of the shaping liquid in the shaping tube 5 is smoother and more controllable, which is beneficial to saving debugging time and making the downward liquid pressure on the leaflet 31 and the upward liquid pressure on the leaflet 31 quickly reach equilibrium.

[0071] The artificial valve shaping processing device of the present application can close the leaflets under the action of liquid reverse pressure, and the shaping liquid chemically modifies the leaflets in the closed state to shape the leaflets.

[0072] The back pressure shaped leaflets 31 form a pocket-shaped structure, and the depth of the base of each leaflet 31 is increased, which is closer to the shape of a human natural valve. One of the functions of the pocket-shaped structure 32 is that when the leaflets 31 are closed, they can buffer the pressure generated by the reverse flow of blood and increase the service life of the artificial valve 30; in addition, they can also reduce the vortex generated by the blood and reduce the risk of thrombosis.

[0073] The free edge curvature of each leaflet 31 formed by back pressure becomes longer, and the junction of the three leaflets 31, i.e., the junction of the leaflets 31, becomes smaller; the leaflets 31 are flatter, and the size and structure are more stable; the relative positions of the leaflets 31 are more stable and consistent, the valve opening and closing effects are better, and the degree of regurgitation is lower, so that the artificial valve 30 has better hemodynamic characteristics.

[0074] The artificial valve shaping processing device of the present application can effectively reduce the leaflet wrinkles, poor consistency of leaflet coaptation, unstable morphological structure and other phenomena existing in existing artificial valves. The shaping process is simple to operate, has good product consistency, high efficiency, and a more stable structure. It is closer to the natural state of the human body, making the valve opening and closing effect better, the fluid mechanics performance better, and the long-term effect of clinical application better, which is of great benefit to doctors and patients.

[0075] It should be noted that: since the leaflets 31 of the artificial valve 30 cannot be completely closed, and since the upward liquid pressure on the leaflets 31 is greater than the downward liquid pressure on the leaflets 31, the setting liquid in the upper container 3 will leak from the closed leaflets 31 and enter the lower container 8, thereby increasing the liquid level of the setting liquid in the lower container 8. The main function of the peristaltic pump 1 is to transport the increased setting liquid in the lower container 8 to the upper container 3, thereby maintaining the liquid level difference between the upper container 3 and the lower container 8 unchanged, thereby ensuring that the reverse liquid pressure on the leaflets 31 remains constant.

[0076] Specifically, Figure 1 , Figure 2 , Figure 6 , Fig. 9 , Fig.10 , Fig.11 , Fig.13 The arrow in the figure indicates the overall circulation flow direction of the shaping liquid during the shaping process of the leaflet 31 .

[0077] Specifically, Figure 4 The arrow in , indicates the opening direction of the leaflet 31 .

[0078] Preferably, a flow regulating switch 6 is provided on the shaping tube 5, and the flow rate of the shaping liquid in the shaping tube 5 can be adjusted by the flow regulating switch 6, which further ensures the flow rate and flow velocity of the shaping liquid flowing out of the shaping tube 5, so that the shaping liquid flowing into the artificial valve 30 is more stable and smooth.

[0079] Preferably, the shaping time of the leaflet 31 is 72 hours.

[0080] Preferably, the fixing solution is a phosphate buffer solution, a low concentration glutaraldehyde solution, a HEPES buffer solution, or one of them or a mixture of two or more thereof.

[0081] Specifically, Figure 2 , Figure 3 , Figure 4 , Figure 5 As shown, the artificial valve loading assembly 20 includes a valve loading tube 9, a hollow plug 11, and a valve loading tube quick-connect connector 10;

[0082] The valve loading tube 9 is vertically arranged in the lower container 8, the valve loading tube 9 is loaded with an artificial valve 30, the hollow plug 11 is located at the top of the valve loading tube 9, and the valve loading tube quick connector 10 is located at the bottom of the valve loading tube 9;

[0083] The other end of the molding tube 5 is connected to the valve loading tube quick connector 10 .

[0084] The present application installs and fixes the artificial valve 30 through the valve loading tube 9. The setting liquid in the lower container 8 enters the interior of the valve loading tube 9 through the hollow plug 11, and applies a downward liquid pressure to the leaflet 31; the setting liquid in the upper container 3 enters the interior of the valve loading tube 9 through the setting tube 5 and the valve loading tube quick connector 10. The setting liquid in the setting tube 5 flows through the artificial valve 30 from bottom to top, and applies an upward liquid pressure to the leaflet 31. This arrangement allows the downward liquid pressure on the leaflet 31 and the upward liquid pressure on the leaflet 31 to quickly reach equilibrium. At the same time, it is convenient to control parameters, reduce debugging difficulty, save debugging time, and improve the efficiency of this process.

[0085] Specifically, the valve loading tube 9 and the artificial valve 30 are assembled together by interference fit to fix the artificial valve 30;

[0086] The hollow plug 11 is assembled with the valve inflow end of the artificial valve 30 by interference fit, so as to fix the valve inflow end.

[0087] Preferably, the valve loading tube 9 is made of a silicone hose with high transparency or a PC hard tube with high transparency.

[0088] The present application fixes the circumferential and axial position of the artificial valve 30 to prevent the artificial valve 30 from moving in the valve loading tube 9, thereby improving the shaping efficiency and success rate of the leaflets 31 and avoiding adverse phenomena such as paravalvular leakage.

[0089] Specifically, the valve loading tube quick connector 10 is connected to the valve loading tube 9 via an O-ring 12, or the valve loading tube quick connector 10 is directly connected to the valve loading tube 9 via an interference fit.

[0090] Preferably, the valve loading tube 9 and the valve loading tube quick connector 10 are connected by an O-ring 12, which is easy to assemble and disassemble, and convenient to clean and replace. The O-ring 12 can be one or more, and using two or more O-rings 12 is conducive to providing better connection strength and sealing performance. Alternatively, the valve loading tube 9 is made of high-elasticity silicone, and is connected to the valve loading tube quick connector 10 by interference fit.

[0091] Preferably, the O-ring 12 is made of silicone, but may also be made of other elastomeric materials.

[0092] Specifically, the hollow plug 11 is provided with a plug hole 111 , and the setting liquid in the lower container 8 enters into the interior of the valve loading tube 9 through the plug hole 111 .

[0093] The installation method of the artificial valve loading assembly 20 and the lower container 8 can be selected from the following two methods:

[0094] The first one:

[0095] like Figure 1 , Figure 6 As shown, it also includes a mounting bracket 13, which is arranged in the lower container 8, and the artificial valve loading assembly 20 is installed on the mounting bracket 13. The mounting bracket 13 is provided with through holes corresponding to the positions of the valve loading tube quick-connect connectors 10 of each artificial valve loading assembly 20; the mounting bracket 13 is a height-adjustable bracket.

[0096] Install the artificial valve loading assembly 20 onto the mounting bracket 13, then pass the valve loading tube quick connector 10 through the through hole on the mounting bracket 13 and connect it to the molding tube 5, finally put the assembled whole into the lower container 8, the molding tube 5 is arranged on the inner side of the lower container 8 and connected to the valve loading tube quick connector 10; a plurality of through holes can be arranged on the mounting bracket 13 to facilitate the installation of a plurality of artificial valve loading assemblies 20; the corresponding plurality of artificial valve loading assemblies 20 need to be equipped with a plurality of molding tubes 5, the number of artificial valve loading assemblies 20 is consistent with the number of molding tubes 5, and a flow regulating switch 6 is arranged on the plurality of molding tubes 5.

[0097] In the above embodiment, the artificial valve loading assembly 20 is installed by the mounting bracket 13, which facilitates the installation of the artificial valve loading assembly 20 and the overall placement after shaping. The mounting bracket 13 can select different support feet, and the bolt support feet are equipped with nuts, so that the height of the mounting bracket 13 can be adjusted.

[0098] Second type:

[0099] like Fig.10 As shown, by opening a hole at the bottom of the lower container 8, the valve loading tube quick-connect connector 10 of each artificial valve loading assembly 20 is passed through the bottom of the lower container 8 and exposed.

[0100] The molding tube 5 is arranged on the outside of the lower container 8 and connected to the exposed valve loading tube quick-connect joint 10; multiple holes can be set at the bottom of the lower container 8 at the same time to facilitate the installation of multiple artificial valve loading components 20; the corresponding multiple artificial valve loading components 20 need to be equipped with multiple molding tubes 5, the number of artificial valve loading components 20 is consistent with the number of molding tubes 5, and the multiple molding tubes 5 are all provided with flow regulating switches 6.

[0101] In the above embodiment, the artificial valve loading assembly 20 is directly connected to the lower container 8, and a sealing washer 17 is sleeved on the valve loading tube quick connector 10. The valve loading tube quick connector 10 and the hole at the bottom of the lower container 8 are sealed by the sealing washer 17 to prevent liquid leakage. This method can directly and quickly realize the installation of the device.

[0102] Specifically, Figure 1 , Figure 6 , Fig.10 As shown, it also includes an upper container drainage pipe 7, one end of which is connected to the side wall of the upper container 3 through a pipeline quick-connect joint 4, and the other end of the upper container drainage pipe 7 is connected to the lower container 8.

[0103] When the shaping liquid in the upper container 3 is full, it flows into the lower container 8 through the upper container discharge pipe 7, so that the liquid level is stable. After stabilization, there is no liquid flow, and the required liquid pressure is achieved. At this time, the shaping timing can be officially started.

[0104] The function of the upper container drain pipe 7 is to ensure that the liquid level in the upper container 3 is stable and accurate during the shaping process.

[0105] Preferably, Fig.11 As shown, the pipeline quick connector 4 is provided with a threaded structure (or a plug-in structure) and a pagoda structure. The pipeline quick connector 4 can be connected to the upper container 3 and the lower container 8 through the threaded structure (or the plug-in structure). The optional methods include direct threaded connection, or a combination of thin nuts and silicone flat washers. The pagoda structure of the pipeline quick connector 4 is interference-connected with the upper container drain pipe 7. The pagoda structure ensures that the connection between the pipeline quick connector 4 and the upper container drain pipe 7 has excellent connection strength and sealing performance. The connection and disassembly of the pipeline quick connector 4 and the upper container drain pipe 7 are simple and convenient, and the cleaning and replacement of each part are very convenient, which meets the performance requirements of the liquid circuit.

[0106] Preferably, the length of the pagoda-shaped structure of the pipe quick-connect joint 4 is greater than 20 mm, which is conducive to better ensuring the connection strength and sealing performance.

[0107] In the above embodiment, the upper container 3 is arranged above the lower container 8 via a supporting structure.

[0108] Specifically, Figure 1 As shown, the support structure may be a support frame 16, which includes a support rod 161 and an upper support plate 162 and a lower support plate 163 mounted on the support rod 161. The upper container 3 is placed on the upper support plate 162, and the lower container 8 is placed on the lower support plate 163. The installation positions of the upper support plate 162 and the lower support plate 163 on the support rod 161 are adjustable. By adjusting the distance between the upper support plate 162 and the lower support plate 163, the height difference between the liquid levels of the setting liquid in the upper container 3 and the lower container 8 reaches the target height difference value.

[0109] For example, when the artificial valve 30 is a pulmonary valve, the height difference between the liquid levels in the upper container 3 and the lower container 8 is 18 cm to 34 cm.

[0110] For example, when the artificial valve 30 is an active valve, the height difference between the liquid levels in the upper container 3 and the lower container 8 is 135 cm ± 15 cm.

[0111] For example, when the artificial valve 30 is a mitral valve, the height difference between the liquid levels in the upper container 3 and the lower container 8 is 165 cm±15 cm.

[0112] For example, when the artificial valve 30 is a tricuspid valve, the height difference between the liquid levels in the upper container 3 and the lower container 8 is 25 cm to 48 cm.

[0113] Preferably, the support frame 16 is a stainless steel support.

[0114] Embodiment 2:

[0115] Embodiment 2 of the present application provides an artificial valve shaping processing method using the artificial valve shaping processing device of embodiment 1, such as Fig.16 As shown, the following steps are included:

[0116] Step S10: reversely loading the artificial valve 30 into the artificial valve loading assembly 20;

[0117] Step S20: Turn on the flow regulating switch 6 on the shaping tube 5, and the shaping liquid in the upper container 3 enters the interior of the artificial valve loading assembly 20 from the bottom of the artificial valve loading assembly 20 through the shaping tube 5. The shaping liquid in the upper container 3 flows through the artificial valve 30 from bottom to top, exerting an upward reverse pressure F on the leaflet 31. 瓣叶， The leaflet 31 is in a closed state;

[0118] Step S30: Turn on the peristaltic pump 1 to pump the setting liquid in the lower container 8 into the upper container 3, and the setting liquid in the upper container 3 flows into the lower container 8 through the setting tube 5 and the upper container drain tube 7; control the flow rate of the peristaltic pump 1 to stabilize the liquid levels of the setting liquid in the upper container 3 and the lower container 8 to form a dynamic balance;

[0119] Step S40: The height difference Δh between the liquid levels in the upper container and the lower container is the reverse pressure applied to the leaflet during the shaping process; the magnitude of the reverse pressure applied to the leaflet can be adjusted by adjusting the value of Δh, so that the leaflet shaping can achieve the desired effect;

[0120] Step S50: The shaping liquid chemically modifies the closed leaflets for a certain period of time (preferably 72 hours) to complete shaping of the leaflets.

[0121] Through the shaping method of the present application, under the action of liquid reverse pressure, the leaflets can be in a closed state, and the shaping liquid chemically modifies the leaflets in the closed state to shape the leaflets.

[0122] The back pressure shaped leaflets 31 form a pocket-shaped structure, and the depth of the base of each leaflet 31 is increased, which is closer to the shape of a human natural valve. One of the functions of the pocket-shaped structure 32 is that when the leaflets 31 are closed, they can buffer the pressure generated by the reverse flow of blood and increase the service life of the artificial valve 30; in addition, they can also reduce the vortex generated by the blood and reduce the risk of thrombosis.

[0123] The free edge curvature of each leaflet 31 formed by back pressure becomes longer, and the junction of the three leaflets 31, i.e., the junction of the leaflets 31, becomes smaller; the leaflets 31 are flatter, and the size and structure are more stable; the relative positions of the leaflets 31 are more stable and consistent, the valve opening and closing effects are better, and the degree of regurgitation is lower, so that the artificial valve 30 has better hemodynamic characteristics.

[0124] The artificial valve shaping method of the present application can effectively reduce the leaflet wrinkles, poor consistency of leaflet coaptation, unstable morphological structure and other phenomena existing in existing artificial valves. The shaping process is simple to operate, has good product consistency, high efficiency, and a more stable structure. It is closer to the natural state of the human body, making the valve opening and closing effect better, the fluid mechanics performance better, and the long-term effect of clinical application better, which is of great benefit to doctors and patients.

[0125] Specifically, refer to Fig.13 The reverse pressure F of the leaflet 31 is described. 瓣叶 =ρgsΔh, where ρ is the density of the setting liquid; g is the acceleration due to gravity; s is the cross-sectional area after the leaflet is closed; and Δh is the height difference between the liquid levels in the upper container and the lower container.

[0126] Specifically, in step S10, reverse loading the artificial valve 30 into the artificial valve loading component 20 means that the opening direction of the leaflets 31 of the artificial valve 30 is set toward the bottom of the artificial valve loading component 20, so that the flow direction of the shaping liquid flowing through the artificial valve 30 is opposite to the opening direction of the leaflets 31.

[0127] Preferably, the reverse pressure value required for shaping the leaflet 31 can be determined according to the usage scenario of the artificial valve 30.

[0128] It should be noted that: the usage scenario of the artificial valve 30 refers to: the artificial valve 30 is divided into an artificial valve for the left heart and an artificial valve for the right heart.

[0129] For the liquid pressure values ​​required for shaping the corresponding leaflets 31 of the artificial valves for the left heart and the artificial valves for the right heart, please refer to the peak pressure difference across the closed valve in the industry standard document: YY / T1449.3-2016 / ISO 5840-3:2013.

[0130] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of this patent, rather than to limit it. Although this patent has been described in detail with reference to the aforementioned embodiments, ordinary technicians in this field should understand that they can still modify the technical solutions recorded in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. These modifications or replacements do not cause the essence of the corresponding technical solution to deviate from the scope of the technical solutions of the embodiments of this patent.

Claims

1. An artificial valve shaping and processing device, characterized in that: It includes a peristaltic pump, a liquid supply tube, an upper container, a lower container, an artificial valve loading component and a molding tube; The liquid supply pipe is installed on the peristaltic pump, the liquid inlet end of the liquid supply pipe is connected to the lower container, and the liquid outlet end of the liquid supply pipe is connected to the upper container; The upper container and the lower container are both provided with setting liquid; The artificial valve loading assembly is arranged in the lower container, the artificial valve loading assembly is immersed in the shaping liquid in the lower container, the top of the artificial valve loading assembly is connected to the lower container, the artificial valve is loaded in the artificial valve loading assembly, one end of the shaping tube is connected to the bottom of the upper container, and the other end of the shaping tube is connected to the bottom of the artificial valve loading assembly; The opening direction of the leaflets of the artificial valve is set toward the bottom of the artificial valve loading component so that the flow direction of the setting liquid flowing through the artificial valve is opposite to the opening direction of the leaflets, thereby allowing the artificial valve to be reversely loaded in the artificial valve loading component.

2. The artificial valve shaping and processing device according to claim 1, characterized in that: The artificial valve loading assembly comprises a valve loading tube, a hollow plug, and a valve loading tube quick-connect joint; The valve loading tube is vertically arranged in the lower container, the valve loading tube is loaded with an artificial valve, the hollow plug is located at the top of the valve loading tube, and the valve loading tube quick connector is located at the bottom of the valve loading tube; The other end of the shaping tube is connected to the valve loading tube quick-connect joint.

3. The artificial valve shaping and processing device according to claim 2, characterized in that: The valve loading tube and the artificial valve are assembled together by interference fit, and are used to fix the artificial valve; The hollow plug is assembled with the valve inflow end of the artificial valve in an interference fit manner to fix the valve inflow end.

4. The artificial valve shaping and processing device according to claim 2, characterized in that: The valve loading tube quick connector is connected to the valve loading tube via an O-ring, or the valve loading tube quick connector is directly connected to the valve loading tube via an interference fit.

5. The artificial valve shaping and processing device according to claim 2, characterized in that: It also includes a mounting bracket, which is arranged in the lower container, the artificial valve loading assembly is installed on the mounting bracket, and the mounting bracket is provided with through holes at positions corresponding to the valve loading tube quick-connect joints of each artificial valve loading assembly; The mounting bracket is a height-adjustable bracket; The shaping tube is arranged on the inner side of the lower container and is connected with the quick-connect connector.

6. The artificial valve shaping and processing device according to claim 2, characterized in that: The valve loading tube quick-connect connector of each artificial valve loading assembly is exposed outside through the bottom of the lower container; The shaping tube is arranged on the outside of the lower container and is connected to the quick-connect joint of the valve loading tube which is exposed outside.

7. The artificial valve shaping and processing device according to claim 1, characterized in that: The shaping tube is provided with a flow regulating switch.

8. The artificial valve shaping and processing device according to claim 1, characterized in that: It also includes an upper container drainage pipe, one end of which is connected to the side wall of the upper container through a pipeline quick-connect joint, and the other end of the upper container drainage pipe is connected to the lower container.

9. A method for shaping an artificial valve using the artificial valve shaping device according to any one of claims 1 to 8, characterized in that: The steps include: Step S10: reversely loading the artificial valve into the artificial valve loading assembly; Step S20: Turn on the flow regulating switch on the shaping tube, and the shaping liquid in the upper container enters the interior of the artificial valve loading component from the bottom of the artificial valve loading component through the shaping tube. The shaping liquid in the upper container flows through the artificial valve from bottom to top, exerting an upward reverse pressure F on the leaflet. 瓣叶， Keep the valve leaflets closed; Step S30: turning on the peristaltic pump to pump the setting liquid in the lower container into the upper container, and the setting liquid in the upper container flows into the lower container through the setting pipe and the upper container drain pipe; controlling the flow rate of the peristaltic pump to stabilize the liquid levels of the setting liquid in the upper container and the lower container to form a dynamic balance; Step S40: The height difference Δh between the liquid levels in the upper container and the lower container is the reverse pressure applied to the leaflet during the shaping process; the magnitude of the reverse pressure applied to the leaflet can be adjusted by adjusting the value of Δh, so that the leaflet shaping can achieve the desired effect; Step S50: The shaping liquid chemically modifies the closed leaflets for a certain period of time to complete shaping of the leaflets.

10. The artificial valve shaping method according to claim 9, characterized in that: The reverse pressure F on the leaflet 瓣叶 =ρgsΔh, where ρ is the density of the setting liquid; g is the acceleration due to gravity; s is the cross-sectional area after the leaflet is closed; and Δh is the height difference between the liquid levels in the upper container and the lower container.

11. The artificial valve shaping method according to claim 9, characterized in that: In step S10, reverse loading the artificial valve into the artificial valve loading component means that the opening direction of the leaflets of the artificial valve is set toward the bottom of the artificial valve loading component so that the flow direction of the shaping liquid flowing through the artificial valve is opposite to the opening direction of the leaflets.

12. The artificial valve shaping method according to claim 9, characterized in that: The reverse pressure value required for leaflet shaping can be determined according to the usage scenario of the artificial valve.

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