A fatigue testing device for cardiac occluder

By providing a fatigue testing device for a cardiac occluder, the fluid delivery unit and the clamping unit simulate the physiological environment of the cardiac occluder at the ventricular septal defect, the problem of difficulty in testing the stability performance of the cardiac occluder in the prior art is solved, and an effective evaluation of the position stability and structural fatigue of the cardiac occluder is achieved.

CN119309944BActive Publication Date: 2025-04-25BEIHANG UNIV

Patent Information

Application Number
CN202411874873.5
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-12-19
Publication Date
2025-04-25
Estimated Expiration
2044-12-19

AI Technical Summary

Technical Problem

The prior art is difficult to effectively test whether the cardiac occluder meets the requirements of position stability during long-term service and the structural damage after long-term resistance to blood flow shock.

Method used

A fatigue testing device for a cardiac occluder is provided, including a liquid supply unit and a clamping unit. The liquid supply unit controls the temperature of the test solution through the temperature control element, and adjusts the pressure on both sides of the heart occluder through the power mechanism to simulate the physiological environment of the heart occluder at the ventricular septal defect. The clamping unit clamps the heart occluder through the first and second joints to form a test chamber to observe liquid ooze and damage.

Benefits of technology

The device can simulate the physiological environment in which the cardiac occluder is in vitro for a long time in service in the body, evaluate the position stability and structural fatigue performance of the cardiac occluder, and provide convenient stability performance evaluation.

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Abstract

The present invention discloses a fatigue test device for a cardiac occluder, comprising a liquid supply unit and a clamping unit. The liquid supply unit comprises a liquid storage mechanism capable of containing a test solution, and the liquid storage mechanism can be connected to a power mechanism; the clamping unit comprises a first joint and a second joint. The cardiac occluder of the cardiac occluder is placed between the first joint and the second joint, and the cardiac occluder to be tested is fixed after the first joint is connected to the second joint, and a test solution is injected into the liquid storage mechanism. A temperature control element can control the temperature of the test solution to meet the test conditions. The first joint is connected to the liquid storage mechanism, and the power mechanism is used to transport the test solution into the liquid storage mechanism, and the pressure on both sides of the cardiac occluder is adjusted to simulate the elastic state of the cardiac occluder directly contacting the soft tissue at the ventricular septal defect, and the liquid seepage at the cardiac occluder and the damage of the cardiac occluder after the test are observed, so as to obtain the fatigue performance data of the cardiac occluder.
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Description

Technical Field

[0001] The invention relates to the technical field of testing the stability and fatigue performance of implantable medical devices, and in particular to a fatigue testing device for a cardiac occluder. Background Art

[0002] Ventricular septal defect is a common congenital heart disease. Since the pressure in the left ventricle is higher than that in the right ventricle, when a ventricular septal defect occurs, the blood in the left ventricle of the child will flow into the right ventricle through the defect and into the pulmonary artery, causing pulmonary hypertension, which in turn leads to serious consequences such as developmental delay, heart failure, and even death. Currently, more than 50% of complex congenital heart diseases are accompanied by ventricular septal defect. The main clinical treatment for this disease is interventional therapy with a cardiac occluder, which is less invasive, simple to operate, and has fewer complications. It is the mainstream medical treatment.

[0003] The types of occluders on the market include non-degradable nickel-titanium alloy heart occluders, partially degradable biofilm heart occluders, and fully degradable occluders such as high-molecular polylactic acid. Although the materials of these occluders are different, their structures generally include a left-side flow-blocking membrane, a right-side flow-blocking membrane, and a waist connection in the middle. Due to the different pressures in the left and right ventricles, the pressure in the left ventricle is 50-110 mmHg higher than that in the right ventricle. When the ventricular septal defect heart occluder is working, it is mainly subjected to pressure from the left side of the ventricle. This requires that the support force of the left-side flow-blocking membrane is sufficient to resist the impact of blood flow, and its stability can still be guaranteed under long-term impact.

[0004] The fatigue test of the cardiac occluder is an important test to evaluate the functionality and structural integrity of the occluder after long-term implantation. It is to evaluate its durability and stability under the influence of long-term blood flow impact and heart beat. As an important part of the cardiac occluder, the long-term stability test of the cardiac occluder is crucial to ensure the safety and effectiveness of the occluder. Summary of the invention

[0005] The purpose of the present invention is to provide a fatigue testing device for a cardiac occluder to solve the problems existing in the above-mentioned prior art and simulate the physiological environment under the state of ventricular septal defect in vivo. After the cardiac occluder is fixed on the fatigue testing device, it can be tested in vitro whether the cardiac occluder meets the position stability performance requirements of the ventricular septal defect cardiac occluder during long-term service in vivo and whether the structural damage of the cardiac occluder after long-term resistance to blood flow impact.

[0006] To achieve the above object, the present invention provides the following solutions:

[0007] The present invention provides a fatigue testing device for a cardiac occluder, comprising:

[0008] A liquid supply unit, the liquid supply unit comprising a liquid storage mechanism capable of containing a test solution, wherein a temperature control element is arranged in the liquid storage mechanism to control the temperature of the test solution in the liquid storage mechanism; the liquid storage mechanism can be connected to a power mechanism to drive the test solution in the liquid storage mechanism;

[0009] A clamping unit, the clamping unit includes a first joint and a second joint, one end of the first joint is connected to the liquid storage mechanism, the other end of the first joint is detachably connected to the second joint, the first joint and the second joint cooperate to clamp the heart occluder to be tested, the heart occluder to be tested blocks the connection between the first joint and the second joint, the heart occluder to be tested and the inner cavity of the first joint form a first test cavity, and the heart occluder to be tested and the inner cavity of the second joint form a second test cavity.

[0010] Preferably, the liquid storage mechanism comprises a liquid storage tank and a sealing cover arranged on the top of the liquid storage tank, the liquid storage tank and the sealing cover are detachably connected, and a sealing ring is arranged between the two; and an exhaust port is arranged on the sealing cover.

[0011] Preferably, the liquid storage tank is a cylindrical structure, and the temperature control element is coaxially arranged with the liquid storage tank;

[0012] The number of the clamping units is multiple groups, and the clamping units are evenly distributed around the axis of the liquid storage tank;

[0013] The liquid storage tank is connected to the sealing cover by means of fixing screws. There are a plurality of fixing screws, and the fixing screws are evenly distributed circumferentially around the axis of the liquid storage tank.

[0014] Preferably, the first joint comprises a first interface tube, a first test tube and a first fixed tube which are connected in sequence, and the first interface tube is detachably connected to the liquid storage mechanism;

[0015] The second joint comprises a second test tube and a second fixed tube which are connected in sequence, and an end of the second test tube away from the second fixed tube is a sealed end;

[0016] The first fixing tube and the second fixing tube are both provided with installation positions capable of accommodating the cardiac occluder to be tested at their tube openings, and a sealing gasket is provided between the first fixing tube and the second fixing tube, and the sealing gasket is an annular structure;

[0017] The first test tube and the second test tube can both be connected to a testing instrument.

[0018] Preferably, the first interface pipe is threadedly connected to the liquid storage mechanism.

[0019] Preferably, both the first test tube and the second test tube have a sensor interface for installing a test sensor.

[0020] Preferably, the first connector and the second connector are both made of transparent material.

[0021] Preferably, the clamping unit is arranged to be gradually tilted downward from the connection point between the first joint and the liquid storage mechanism toward the second joint.

[0022] Preferably, the clamping unit further comprises a clamp, and the first joint and the second joint are detachably connected by the clamp.

[0023] Preferably, the clamp includes two semicircular clamping rings, one end of the two clamping rings are hinged, and a locking pin is provided at the other end of the two clamping rings. One end of the locking pin is hinged to one of the clamping rings, and the other end of the locking pin has a locking section, and the other clamping ring has a locking groove matched with the locking section. The locking pin is rotated to make the locking section extend into the locking groove to achieve the locking of the clamp.

[0024] Compared with the prior art, the present invention achieves the following technical effects: the fatigue testing device for a cardiac occluder of the present invention comprises a liquid supply unit and a clamping unit, the liquid supply unit comprises a liquid storage mechanism capable of accommodating a test solution, a temperature control element is arranged in the liquid storage mechanism to control the temperature of the test solution in the liquid storage mechanism; the liquid storage mechanism can be connected to a power mechanism to drive the test solution in the liquid storage mechanism; the clamping unit comprises a first joint and a second joint, one end of the first joint is connected to the liquid storage mechanism, the other end of the first joint is detachably connected to the second joint, the first joint and the second joint cooperate to clamp the cardiac occluder to be tested, the cardiac occluder to be tested blocks the connection between the first joint and the second joint, the inner cavity of the cardiac occluder to be tested and the first joint enclose a first test cavity, and the inner cavity of the cardiac occluder to be tested and the second joint enclose a second test cavity.

[0025] The fatigue testing device for a cardiac occluder of the present invention places the cardiac occluder of the cardiac occluder between a first joint and a second joint, fixes the cardiac occluder to be tested after the first joint is connected to the second joint, injects a test solution into a liquid storage mechanism, and a temperature control element can control the temperature of the test solution to meet the test conditions. The first joint is connected to the liquid storage mechanism, and the test solution enters the first test cavity. Due to the obstruction of the cardiac occluder, the test solution cannot enter the second joint, but the cardiac occluder is made of elastic material, and the pressure in the second test cavity is still affected by the pressure in the first test cavity and the deformation of the cardiac occluder. The power mechanism is used to transport the test solution into the liquid storage mechanism, and the pressure on both sides of the cardiac occluder is adjusted to simulate the elastic state of the cardiac occluder directly contacting the soft tissue at the ventricular septal defect, observe the liquid seepage at the cardiac occluder and the damage of the cardiac occluder after the test, so as to obtain the fatigue performance data of the cardiac occluder, and provide convenience for the stable performance evaluation of the cardiac occluder. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0027] Figure 1 It is a structural schematic diagram of a fatigue testing device for a cardiac occluder disclosed in an embodiment of the present invention;

[0028] Figure 2 A schematic diagram of the structure of a liquid storage tank of a fatigue testing device for a cardiac occluder disclosed in an embodiment of the present invention;

[0029] Figure 3 A schematic cross-sectional structure diagram of a liquid storage tank of a fatigue testing device for a cardiac occluder disclosed in an embodiment of the present invention;

[0030] Figure 4 A schematic structural diagram of a clamping unit of a fatigue testing device for a cardiac occluder disclosed in an embodiment of the present invention;

[0031] Figure 5 It is a schematic diagram of the disassembly of a part of the structure of the clamping unit of the fatigue testing device of the cardiac occluder disclosed in the embodiment of the present invention;

[0032] Figure 6 A schematic structural diagram of a first joint of a fatigue testing device for a cardiac occluder disclosed in an embodiment of the present invention;

[0033] Figure 7This is a schematic structural diagram of a second joint of a fatigue testing device for a cardiac occluder disclosed in an embodiment of the present invention.

[0034] In the figure: 100, fatigue testing device for cardiac occluder;

[0035] 1. Liquid supply unit; 2. Clamping unit; 3. Temperature control element; 4. First joint; 5. Second joint; 6. Liquid storage tank; 7. Sealing cover; 8. Exhaust port; 9. Fixing screw; 10. First interface tube; 11. First test tube; 12. First fixed tube; 13. Second test tube; 14. Second fixed tube; 15. Mounting position; 16. Sealing gasket; 17. Sensor interface; 18. Clamp; 19. Snap ring; 20. Locking pin; 21. Locking section; 22. Locking groove. DETAILED DESCRIPTION

[0036] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. 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.

[0037] The purpose of the present invention is to provide a fatigue testing device for a cardiac occluder to solve the problems existing in the above-mentioned prior art and simulate the physiological environment under the state of ventricular septal defect in vivo. After the cardiac occluder is fixed on the fatigue testing device, it can be tested in vitro whether the cardiac occluder meets the position stability performance requirements of the ventricular septal defect cardiac occluder during long-term service in vivo and whether the structural damage of the cardiac occluder after long-term resistance to blood flow impact.

[0038] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0039] Embodiment 1

[0040] The present embodiment provides a fatigue testing device 100 for a cardiac occluder, comprising a liquid supply unit 1 and a clamping unit 2. The liquid supply unit 1 comprises a liquid storage mechanism capable of accommodating a test solution. A temperature control element 3 is arranged in the liquid storage mechanism to control the temperature of the test solution in the liquid storage mechanism. The liquid storage mechanism can be connected to a power mechanism to drive the test solution in the liquid storage mechanism. The clamping unit 2 comprises a first joint 4 and a second joint 5. One end of the first joint 4 is connected to the liquid storage mechanism, and the other end of the first joint 4 is detachably connected to the second joint 5. The first joint 4 and the second joint 5 cooperate to clamp the cardiac occluder to be tested. The cardiac occluder to be tested blocks the connection between the first joint 4 and the second joint 5. The inner cavity of the cardiac occluder to be tested and the first joint 4 forms a first test cavity, and the inner cavity of the cardiac occluder to be tested and the second joint 5 forms a second test cavity.

[0041] The fatigue testing device 100 of the cardiac occluder of the present invention places the cardiac occluder of the cardiac occluder between the first joint 4 and the second joint 5. After the first joint 4 is connected to the second joint 5, the cardiac occluder to be tested is fixed, and a test solution is injected into the liquid storage mechanism. The temperature control element 3 can control the temperature of the test solution to meet the test conditions. The first joint 4 is connected to the liquid storage mechanism, and the test solution enters the first test cavity. Due to the obstruction of the cardiac occluder, although the test solution cannot enter the second joint 5, the cardiac occluder is made of elastic material, and the pressure in the second test cavity is still affected by the pressure in the first test cavity and the deformation of the cardiac occluder. The power mechanism is used to transport the test solution into the liquid storage mechanism, and the pressure on both sides of the cardiac occluder is adjusted to simulate the elastic state of the cardiac occluder directly contacting the soft tissue at the ventricular septal defect, and observe the liquid seepage at the cardiac occluder and the damage of the cardiac occluder after the test, so as to obtain the fatigue performance data of the cardiac occluder, which facilitates the evaluation of the stability performance of the cardiac occluder.

[0042] In this specific embodiment, the temperature control element 3 can adjust the temperature of the test solution, for example, heating the test solution to keep it at 37 degrees Celsius, a human body temperature, so as to better simulate the physiological environment of the body under the condition of ventricular septal defect. In other achievable specific embodiments of the present invention, the working state of the temperature control element 3 can also be adjusted according to specific test requirements to meet different test requirements. For example, when accelerated fatigue testing is required, the temperature control element 3 can be adjusted to maintain the temperature of the test solution above 50 degrees Celsius. In addition, the power mechanism can select a pump body, and the type and specification of the pump body can be selected according to actual test requirements to meet different test conditions.

[0043] It should be explained here that the test solution and device specifications can be adjusted according to the actual test needs to simulate the physiological environment of the heart occluder at the ventricular septal defect as realistically as possible, including defect size, physiological temperature, blood flow impact pressure, frequency and liquid environment such as pH value, osmotic pressure, etc., in accordance with the requirements of YY / T1553-2017 "Cardiovascular Implant Heart Occluder" for the stability test environment of the heart occluder. By adjusting the working parameters of the power mechanism and controlling the impact pressure and impact frequency of the heart occluder, the stability and long-term fatigue of the heart occluder at the defect site can be tested simply and quickly.

[0044] Among them, the liquid storage mechanism includes a liquid storage tank 6 and a sealing cover 7 arranged on the top of the liquid storage tank 6. The liquid storage tank 6 and the sealing cover 7 are detachably connected, and a sealing ring is arranged between the two. The liquid storage mechanism is a split structure, which is convenient for cleaning and maintenance of the liquid storage mechanism and provides convenience for subsequent tests. A sealing ring is arranged between the liquid storage tank 6 and the sealing cover 7 to ensure the sealing of the liquid storage mechanism and avoid leakage. In practical applications, the sealing cover 7 can be made of a transparent material to facilitate observation of the operation of the liquid storage mechanism. In addition, an exhaust port 8 is also arranged on the sealing cover 7 to discharge the gas in the liquid storage mechanism to avoid affecting the test results of the device.

[0045] In this specific embodiment, the liquid reservoir 6 is a cylindrical structure, and the temperature control element 3 is coaxially arranged with the liquid reservoir 6, which is conducive to ensuring the temperature uniformity of the test solution in the liquid reservoir 6. The liquid reservoir 6 is made of polytetrafluoroethylene material, which is resistant to high pressure, high temperature, acid and alkali corrosion, and prolongs the service life of the liquid reservoir 6.

[0046] In practical applications, the number of the clamping units 2 can be set to multiple groups to improve the test efficiency and test accuracy. The clamping units 2 are evenly distributed around the axis of the liquid storage tank 6 to ensure uniform liquid inlet.

[0047] It should also be noted that the liquid storage tank 6 and the sealing cover 7 are connected by fixing screws 9, which are tightly connected and easy to disassemble and assemble. There are multiple fixing screws 9, and the fixing screws 9 are evenly distributed around the axis of the liquid storage tank 6 to ensure uniform force on the liquid storage tank 6 and the sealing cover 7.

[0048] Specifically, the first connector 4 includes a first interface tube 10, a first test tube 11 and a first fixed tube 12 which are connected in sequence, and the first interface tube 10 is detachably connected to the liquid storage mechanism; the first connector 4 is connected to the liquid storage mechanism by means of the first interface tube 10. In the present specific embodiment, the first interface tube 10 is connected to the side wall of the liquid storage tank 6 to realize the connection between the first connector 4 and the liquid storage mechanism.

[0049] Correspondingly, the second joint 5 includes a second test tube 13 and a second fixed tube 14 which are connected in sequence, and one end of the second test tube 13 away from the second fixed tube 14 is a sealed end.

[0050] In order to enhance the fixing effect of the first joint 4 and the second joint 5 on the cardiac occluder, the tube openings of the first fixing tube 12 and the second fixing tube 14 are provided with mounting positions 15 capable of accommodating the cardiac occluder to be tested, and a sealing gasket 16 is provided between the first fixing tube 12 and the second fixing tube 14. The sealing gasket 16 is an annular structure, and the first fixing tube 12 and the second fixing tube 14 are in contact with and squeezed with the sealing gasket 16 to ensure the sealed connection between the first fixing tube 12 and the second fixing tube 14.

[0051] In this specific embodiment, the sealing gasket 16 is a ring-shaped silicone gasket, which is used as a material in direct contact with the heart occluder, so as to better simulate the mechanical state of the surrounding soft tissue of the heart occluder in service. In addition, by replacing the first connector 4 and the second connector 5 of different specifications, the stability and fatigue performance of the heart occluder with different defect diameters in the ventricular septum can be tested at the same time. In practical applications, the sealing gasket 16 can be an O-ring or other annular sealing structure to avoid affecting the contact between the heart occluder and the test solution.

[0052] More specifically, both the first test tube 11 and the second test tube 13 can be connected to a test instrument to facilitate detection of the pressure states in the first test cavity and the second test cavity, providing convenience for testers.

[0053] In this specific embodiment, the first interface tube 10 is threadedly connected to the liquid storage mechanism, and the connection is tight and convenient for assembly and disassembly. A sealed threaded connection can be selected to avoid leakage.

[0054] In practical applications, both the first test tube 11 and the second test tube 13 have a sensor interface 17 for installing a test sensor. By installing the pressure sensor on the sensor interface 17, the pressure changes in the first test cavity and the second test cavity can be conveniently monitored. It should also be noted here that in practical applications, a three-way connector can be installed through the sensor interface 17 on the second test tube 13. After the three-way connector is installed, while meeting the test sensor installation requirements, the second test tube 13 can also be connected to other mechanisms, such as an external pressurizing mechanism, etc. The external pressurizing mechanism can be used to pressurize the cardiac occluder from one side of the second test tube 13 to meet different detection requirements and further improve the flexibility and adaptability of the device. Similarly, the sensor interface 17 of the first test tube 11 can also be equipped with additional connectors to meet different detection conditions.

[0055] It should also be noted that the first connector 4 and the second connector 5 are both made of transparent material, and acrylic material may be selected to facilitate observation of damage to the cardiac occluder and displacement changes of the cardiac occluder under pressure.

[0056] When testing, a heart occluder to be tested is set at the installation position 15, and pressure test points are selected on both sides of the heart occluder. A first pressure test point is selected on one side of the first test tube 11 to simulate whether the left atrial or left ventricular pressure meets the requirements, and a second pressure test point is selected on one side of the second test tube 13 to simulate whether the right atrial or right ventricular pressure meets the requirements. The displacement change of the heart occluder can be observed through the first test tube 11 and the second test tube 13 made of transparent materials; when the heart occluder is damaged, the first test tube 11 is connected to the second test tube 13, and the pressure value of the first pressure test point is equal to the pressure value of the second pressure test point.

[0057] Furthermore, the clamping unit 2 is gradually tilted downward from the connection point between the first joint 4 and the liquid storage mechanism toward the second joint 5, which is used for exhausting the first joint 4. When the device generates pressure through the power mechanism, the pressure measurement accuracy at the sensor interface 17 can be guaranteed. In this specific embodiment, the angle between the axis of the first joint 4 and the horizontal direction is 15°. In practical applications, the tilt angle can also be adjusted according to actual working conditions.

[0058] Furthermore, the clamping unit 2 further comprises a clamp 18, and the first joint 4 and the second joint 5 are detachably connected by the clamp 18, and the clamp 18 is firmly fixed and easy to operate.

[0059] In this specific embodiment, the clamp 18 includes two semicircular clamps 19, one end of the two clamps 19 is hinged, and the other end of the two clamps 19 is provided with a locking pin 20, one end of the locking pin 20 is hinged with a clamp 19, the other end of the locking pin 20 has a locking section 21, and the other clamp 19 has a locking groove 22 adapted to the locking section 21, and the locking pin 20 rotates to make the locking section 21 extend into the locking groove 22 to achieve the locking of the clamp 18, and the clamp 18 is convenient to lock and disassemble. In practical applications, other structures of the clamp 18 can also be selected, such as a bolt locking clamp, or a buckle clamp, etc., to improve the flexibility and adaptability of the device.

[0060] The fatigue testing device 100 of the cardiac occluder of the present invention can simulate the physiological environment of a ventricular septal defect in vivo, including pressure, frequency, temperature, defect location diameter, pH value, osmotic pressure, etc. After the cardiac occluder is fixed on the testing device, it can be tested in vitro whether the cardiac occluder meets the position stability performance requirements of the ventricular septal defect cardiac occluder during long-term service in vivo and the structural damage of the cardiac occluder after long-term resistance to blood flow impact.

[0061] Embodiment 2

[0062] The fatigue test device 100 of the cardiac occluder of this embodiment has the same structure as that of the first embodiment. When testing, the device is fixed on the power mechanism, tilted downward to connect the clamping unit 2, and slowly inject PBS phosphate buffer solution into the liquid storage mechanism to ensure that there is no liquid leakage in the device. The sealing cover 7 and the liquid storage tank 6 are connected by fixing screws 9, and the gas in the device is discharged through the exhaust port 8 to ensure that the device is sealed and there is no gas interference. The pressure sensor is connected through the sensor interface 17 to monitor the pressure on both sides of the cardiac occluder. The temperature control mechanism is adjusted to ensure that the test environment temperature is 37°C, and the power mechanism is adjusted to control the pressure on both sides of the cardiac occluder. The liquid seepage at the second joint 5 and the damage of the cardiac occluder after the test are observed.

[0063] The present invention uses specific examples to illustrate the principles and implementation methods of the present invention. The above examples are only used to help understand the method and core ideas of the present invention. At the same time, for those skilled in the art, according to the ideas of the present invention, there will be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as limiting the present invention.

Claims

1. A fatigue testing device for a cardiac occluder, characterized in that: include: A liquid supply unit, the liquid supply unit comprising a liquid storage mechanism capable of containing a test solution, wherein a temperature control element is arranged in the liquid storage mechanism to control the temperature of the test solution in the liquid storage mechanism; the liquid storage mechanism can be connected to a power mechanism to drive the test solution in the liquid storage mechanism; A clamping unit, the clamping unit comprising a first joint and a second joint, one end of the first joint being connected to the liquid storage mechanism, the other end of the first joint being detachably connected to the second joint, the first joint and the second joint being able to cooperate to clamp the cardiac occluder to be tested, the cardiac occluder to be tested blocks the connection between the first joint and the second joint, the inner cavity of the cardiac occluder to be tested and the first joint enclose a first test cavity, and the inner cavity of the cardiac occluder to be tested and the second joint enclose a second test cavity; The liquid storage mechanism comprises a liquid storage tank and a sealing cover arranged on the top of the liquid storage tank, the liquid storage tank and the sealing cover are detachably connected, and a sealing ring is arranged between the two; the sealing cover is provided with an exhaust port; The liquid storage tank is a cylindrical structure, and the temperature control element is coaxially arranged with the liquid storage tank; The number of the clamping units is multiple groups, and the clamping units are evenly distributed around the axis of the liquid storage tank; The liquid storage tank is connected to the sealing cover by fixing screws, the number of the fixing screws is multiple, and the fixing screws are evenly distributed around the axis of the liquid storage tank; The clamping unit is gradually tilted downward from the connection point between the first joint and the liquid storage mechanism toward the second joint; The first joint comprises a first interface tube, a first test tube and a first fixed tube which are connected in sequence, and the first interface tube is detachably connected to the liquid storage mechanism; The second joint comprises a second test tube and a second fixed tube which are connected in sequence, and an end of the second test tube away from the second fixed tube is a sealed end; The first fixing tube and the second fixing tube are both provided with installation positions capable of accommodating the cardiac occluder to be tested at their tube openings, and a sealing gasket is provided between the first fixing tube and the second fixing tube, and the sealing gasket is an annular structure; The first test tube and the second test tube can both be connected to a test instrument; The first interface pipe is threadedly connected to the liquid storage mechanism; The first test tube and the second test tube both have a sensor interface for installing a test sensor; The first connector and the second connector are both made of transparent material.

2. The fatigue testing device for the cardiac occluder according to claim 1, characterized in that: The clamping unit further includes a clamp, and the first connector and the second connector are detachably connected by the clamp.

3. The fatigue testing device for the cardiac occluder according to claim 2, characterized in that: The clamp includes two semicircular clamping rings, one end of the two clamping rings are hinged, and a locking pin is arranged at the other end of the two clamping rings. One end of the locking pin is hinged to one of the clamping rings, and the other end of the locking pin has a locking section, and the other clamping ring has a locking groove matched with the locking section. The locking pin is rotated to make the locking section extend into the locking groove to realize the locking of the clamp.

Citation Information

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