Testing equipment for artificial vein valve

Abstract

The utility model provides testing equipment for an artificial vein valve, and relates to the technical field of medical instruments. The utility model relates to a first test pipeline and a second test pipeline which are respectively connected to two ends of a to-be-tested pipeline used for arranging a to-be-tested artificial vein valve. The first liquid storage device provides test liquid for the first test pipeline or receives the test liquid, a piston is arranged in the first liquid storage device, and the piston is used for increasing or decreasing the volume of the test liquid in the first liquid storage device; the second liquid storage device is used for providing test liquid for or receiving test liquid from the second test pipeline; and the pressure regulating pipeline is connected with the first liquid storage device and the second liquid storage device, and the pressure regulating pipeline is provided with a flow control mechanism used for regulating the internal flow of the pressure regulating pipeline.

Description

Technical Field

[0001] This specification relates to the field of medical device technology, and in particular to a testing device for artificial venous valves. Background Art

[0002] Veins carry blood from all parts of the body back to the heart. To prevent blood from flowing backward, veins contain valves. When open, these valves allow blood to flow back toward the heart, and when closed, they prevent blood from flowing backward. Venous valves are the "one-way valves" that ensure the veins can transport blood back to the heart. Damage or disease to these valves can cause venous backflow, leading to venous hypertension and, in turn, chronic venous disease (CVD).

[0003] Some scientists have proposed creating artificial venous valves to replace diseased venous valves. These valves can be implanted at the target location of the vein (such as a damaged or diseased native venous valve), replacing the native valve to prevent blood backflow.

[0004] Currently, there is no mature testing method for the key performance parameters of artificial valves. Summary of the Invention

[0005] One or more embodiments of the present specification provide a testing device for an artificial venous valve, such as an impact resistance and fatigue testing device for an artificial venous valve, which is used to obtain key performance parameters of an artificial venous valve, such as for testing the impact resistance and / or fatigue performance of an artificial venous valve, and comprises: a first test pipe and a second test pipe, which are respectively connected to the two ends of the pipe to be tested for arranging the artificial venous valve to be tested; a first liquid storage device, which provides test liquid to the first test pipe or receives test liquid from the first test pipe, and a piston is provided inside the first liquid storage device, and the piston increases or decreases the volume of the test liquid inside the first liquid storage device by displacement; a second liquid storage device, which provides test liquid to the second test pipe or receives test liquid from the second test pipe; a pressure regulating pipe, which connects the first liquid storage device and the second liquid storage device, and the pressure regulating pipe is provided with a flow control mechanism for regulating the internal flow of the pressure regulating pipe.

[0006] The artificial venous valve testing device according to some embodiments of this specification further includes: a linear drive mechanism, which drives the piston to perform reciprocating motion.

[0007] According to the artificial venous valve testing device described in some embodiments of this specification, the pipeline to be tested is a silicone tube or a biological blood vessel, and the liquid to be tested is water, glutaraldehyde solution, or formalin solution.

[0008] According to the artificial venous valve testing device described in some embodiments of this specification, the diameter of the pipe to be tested ranges from 2 to 30 mm, and the operating frequency of the piston ranges from 0 to 30 Hz.

[0009] The artificial venous valve testing device according to some embodiments of this specification further includes: a test liquid container, which is connected to the second liquid storage device.

[0010] According to some embodiments of the present specification, the artificial venous valve testing device further includes: an environmental simulation container, which is provided outside the pipeline to be tested and is used to simulate the working environment of the pipeline to be tested, and the environmental simulation container includes a temperature control device.

[0011] According to the artificial venous valve testing device described in some embodiments of this specification, the pipeline to be tested is arranged inside the environmental simulation container, and the first test pipeline and the second test pipeline pass through the environmental simulation container and are detachably connected to both ends of the pipeline to be tested.

[0012] According to the artificial venous valve testing device described in some embodiments of this specification, the first testing pipe and the pipe to be tested, and the second testing pipe and the pipe to be tested are detachably connected via quick-change connectors.

[0013] According to the artificial venous valve testing equipment described in some embodiments of this specification, the temperature control device includes: a heating device for heating the test liquid in the environmental simulation container, and a temperature sensor for monitoring the temperature of the test liquid.

[0014] According to the artificial venous valve testing device described in some embodiments of this specification, the temperature of the test liquid in the environmental simulation container ranges from 0 to 42°C.

[0015] According to the artificial venous valve testing device according to some embodiments of this specification, the environmental simulation container is provided by the test liquid container.

[0016] The test device for artificial venous valves according to some embodiments of the present specification further includes: a first air cavity, which is directly or indirectly connected to the first test pipe, for receiving a portion of the test liquid from the first test pipe, and for providing pressure-regulated gas in the direction of the first test pipe; and / or a second air cavity, which is directly or indirectly connected to the second test pipe, for receiving a portion of the test liquid from the second test pipe, and for providing pressure-regulated gas in the direction of the second test pipe.

[0017] According to the artificial venous valve testing device described in some embodiments of this specification, the first air cavity is provided at the upper end of the first testing pipe, and the second air cavity is provided at the upper end of the second testing pipe.

[0018] According to the testing equipment for artificial venous valves described in some embodiments of this specification, the piston moves in a horizontal direction or a substantially horizontal direction; the first liquid storage device includes a first liquid storage space and a second liquid storage space that are interconnected, and the piston is arranged in the second liquid storage space; the piston reciprocates inside the second liquid storage space.

[0019] According to the artificial venous valve testing equipment described in some embodiments of this specification, the first liquid storage device includes a first shell and a second shell fixedly connected, the first shell provides the first liquid storage space, and the second shell provides the second liquid storage space.

[0020] According to the test equipment for artificial venous valves described in some embodiments of this specification, the first air cavity and / or the second air cavity further includes: a detachable interface directly or indirectly connected to the first test pipe or the second test pipe; and a Luer connector directly or indirectly connected to the air source.

[0021] According to the testing equipment for artificial venous valves described in some embodiments of the present specification, the first test pipe and the second test pipe both include: a tubular structure, the pipe structure has a three-way structure, the three-way structure has a first interface connected to the first liquid storage device or the second liquid storage device, a second interface connected to the first air cavity or the second air cavity, and a third interface connected to the pipe to be tested.

[0022] According to the testing equipment for artificial venous valves described in some embodiments of this specification, the first air cavity and the second air cavity include: an elastic membrane, which separates the first air cavity or the second air cavity into a first accommodating space and a second accommodating space, and the first accommodating space is located on the upper side of the second accommodating space.

[0023] According to the artificial venous valve testing device described in some embodiments of this specification, the elastic membrane is in a closed setting or an open setting; the outer edge of the elastic membrane is fixedly connected to the inner wall of the first air cavity or the second air cavity.

[0024] According to the artificial venous valve testing device described in some embodiments of this specification, a hole is opened on the elastic membrane.

[0025] The artificial venous valve testing device according to some embodiments of the present specification includes one hole; or includes multiple holes, wherein the multiple holes are arranged in a circular array.

[0026] According to the artificial venous valve testing device described in some embodiments of this specification, the elastic membrane includes a first area and a second area, the first area is opposite to the detachable interface, and the hole is opened in the second area.

[0027] The artificial venous valve testing device according to some embodiments of the present specification includes: a first pressure measuring device provided on the first test pipe, and a second pressure measuring device provided on the second test pipe.

[0028] According to the artificial venous valve testing equipment described in some embodiments of this specification, a first pressure measuring hole for connecting to the first pressure measuring device is opened on the first testing pipe, and a second pressure measuring hole for connecting to the second pressure measuring device is opened on the second testing pipe.

[0029] According to the testing equipment for artificial venous valves described in some embodiments of this specification, the distance between the first pressure measuring hole and the first liquid storage device is greater than 10 times the pipe diameter of the first test pipe, and the distance between the second pressure measuring hole and the second liquid storage device is greater than 10 times the pipe diameter of the second test pipe.

[0030] According to the artificial venous valve testing equipment described in some embodiments of this specification, the distance between the first pressure measuring hole and the artificial venous valve to be tested is greater than 5 times the pipe diameter of the first test pipe, and the distance between the second pressure measuring hole and the artificial venous valve to be tested is greater than 5 times the pipe diameter of the second test pipe.

[0031] According to the artificial venous valve testing device according to some embodiments of this specification, the diameter of the first testing pipe is equal to the diameter of the second testing pipe.

[0032] According to the artificial venous valve testing equipment described in some embodiments of this specification, the first pressure measuring device is connected to the first pressure measuring hole through a first pressure measuring pipe, and the second pressure measuring device is connected to the second pressure measuring hole through a second pressure measuring pipe.

[0033] According to the testing equipment for artificial venous valves described in some embodiments of this specification, the aperture range of the first pressure measuring hole and the second pressure measuring hole is 1-6 mm, the length of the first pressure measuring pipe is greater than twice the diameter of the first pressure measuring hole, and the length of the second pressure measuring pipe is greater than twice the diameter of the second pressure measuring hole.

[0034] According to some embodiments of the present specification, the artificial venous valve testing device further includes: a control module, the control module is connected to the motor signal, the control module is connected to the first pressure measuring device and the second pressure measuring device signal, and the control module includes a wireless transmission module and a wired transmission module.

[0035] According to the artificial venous valve testing device described in some embodiments of this specification, the control module calculates pressure differential data based on data provided by the first pressure measuring device and the second pressure measuring device. The control module adjusts the stroke of the motor based on the pressure differential data to maintain a stable pressure differential. The control module is signal-connected to the temperature control device.

[0036] According to the artificial venous valve testing device described in some embodiments of this specification, a rectifier is provided on the second testing pipe.

[0037] According to the artificial venous valve testing equipment described in some embodiments of this specification, a one-way valve is provided on the pressure regulating pipeline. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] This specification will be further described in the form of exemplary embodiments, which will be described in detail with reference to the accompanying drawings. The same numbers in the drawings represent the same structures or steps.

[0039] Figure 1 is a perspective view of a testing device for an artificial venous valve according to some embodiments of the present specification.

[0040] Figure 2 It is a partially enlarged view of a testing device for an artificial venous valve according to some embodiments of this specification.

[0041] Figure 3 is a side view of a testing device for an artificial venous valve according to some embodiments of the present specification.

[0042] Figure 4 4 is a top view of a testing device for an artificial venous valve according to some embodiments of the present specification.

[0043] Figure 5 is a cross-sectional view of a testing device for an artificial venous valve according to some embodiments of the present specification.

[0044] Figure 6 It is a cross-sectional view of an embodiment of the first air cavity and the second air cavity of the test device for the artificial venous valve shown in some embodiments of this specification.

[0045] Figure 7 It is a cross-sectional view of another embodiment of the first air cavity and the second air cavity of the test device for the artificial venous valve shown in some embodiments of this specification.

[0046] Figure 8 Schematic diagram of an elastic membrane in a closed arrangement of a test device for an artificial venous valve according to some embodiments of the present specification.

[0047] Figure 9 Schematic diagram of an elastic membrane with holes in a testing device for an artificial venous valve according to some embodiments of the present specification.

[0048] Figure 10 It is a schematic diagram of the working state of the test equipment of the artificial venous valve shown in some embodiments of this specification.

[0049] Figure 11 1 is a schematic diagram of the assembly of a rectifier and a one-way valve of a test device for an artificial venous valve according to some embodiments of this specification.

[0050] Figure 12 、 Figure 13 yes Figure 11 A partial enlarged schematic diagram.

[0051] Figure 14 4 is a schematic cross-sectional view of a rectifier of a test device for an artificial venous valve according to some embodiments of the present specification.

[0052] Markings in the figure: 11 first test pipe; 12 second test pipe; 2 pipe to be tested; 31 first liquid storage device; 311 first shell; 312 second shell; 313 third shell; 32 second liquid storage device; 41 piston; 42 motor; 5 pressure regulating pipe; 51 flow control mechanism; 6 test liquid container; 61 heating device; 62 temperature sensor; 63 liquid supply pipe; 71 first air cavity; 72 second air cavity; 73 elastic membrane; 74 hole; 75 Luer connector; 76 detachable interface; 81 tubular structure; 82 three-way structure; 91 first pressure measuring device; 92 second pressure measuring device; 93 first pressure measuring pipe; 94 second pressure measuring pipe; 101 rectifier; 102 one-way valve; 103 bracket; 104 base; 105 controller; 106 host computer. DETAILED DESCRIPTION

[0053] To more clearly illustrate the technical solutions of the embodiments of this specification, the embodiments will be described in detail below with reference to the accompanying drawings. Obviously, the following descriptions are some examples or embodiments of this specification, and those skilled in the art can apply the technical solutions or methods disclosed in this specification to other scenarios based on these technical contents without inventive effort.

[0054] Unless otherwise specified, technical terms used in this specification to describe components, elements, and the like do not necessarily refer to the singular but may include the plural. Generally speaking, terms such as "include" and "comprising" only indicate the inclusion of the steps, elements, or components specifically identified, and these steps, elements, and components do not constitute an exclusive list. For example, the method or device being described may also include other steps or components.

[0055] Chronic venous disease (CVD) often occurs in the lower extremities. It is caused by damaged venous valves, leading to venous backflow and venous hypertension. Data shows that the current prevalence of lower extremity venous disease in my country is 8.89%, representing nearly 100 million patients.

[0056] The human body contains three types of blood vessels: veins, arteries, and capillaries. Only veins have valves, as they carry blood from all parts of the body back to the heart. To prevent this, veins have valves. When open, these valves allow blood to flow back toward the heart, while when closed, they prevent reverse flow. Venous valves are the one-way valves that ensure the veins carry blood back to the heart. Damage to these valves can cause venous backflow, leading to venous hypertension and, in turn, chronic venous disease.

[0057] Since the 1980s, scientists have proposed the creation of artificial venous valves to replace diseased venous valves. However, to date, no artificial venous valve has been approved for clinical use, and therefore there are no relevant standards or mature testing methods for the key performance parameters of artificial venous valves.

[0058] To this end, some embodiments of this specification provide a testing device for an artificial venous valve, which is used to test key performance parameters of the artificial venous valve, such as impact resistance or fatigue performance.

[0059] Figure 1 is a perspective view of a test device for an artificial venous valve according to some embodiments of this specification, such as Figure 1As shown, the test equipment for artificial venous valves provided in some embodiments of the present specification includes: a first test pipe 11, a second test pipe 12, a first liquid storage device 31, a second liquid storage device 32, and a pressure-regulating pipe 5, wherein the first test pipe 11 and the second test pipe 12 are respectively connected to the two ends of the pipe to be tested 2 for arranging the artificial venous valve to be tested; the first liquid storage device 31 provides test liquid to the first test pipe 11 or receives test liquid from the first test pipe 11, and a piston 41 is provided inside the first liquid storage device 31, and the piston 41 is used to increase or decrease the volume of the test liquid inside the first liquid storage device 31; the second liquid storage device 32 provides test liquid to the second test pipe 12 or receives test liquid from the second test pipe 12; the pressure-regulating pipe 5 connects the first liquid storage device 31 and the second liquid storage device 32, and the pressure-regulating pipe 5 is provided with a flow control mechanism 51 for adjusting the internal flow of the pressure-regulating pipe 5.

[0060] It should be noted that the test liquid can form pressures within the first test conduit 11 and the second test conduit 12. For example, a first pressure is formed within the first test conduit 11, and a second pressure is formed within the second test conduit 12. That is, the first pressure and the second pressure are present on both sides of the artificial venous valve to be tested. The first pressure is measured to obtain a first pressure curve P1, and the second pressure is measured to obtain a second pressure curve P2. The first pressure curve P1 and the second pressure curve P2 are calculated to obtain a pressure difference curve P3. By analyzing the first pressure curve P1, the second pressure curve P2, and the third pressure curve P3, the operating state of the artificial venous valve to be tested can be obtained, thereby obtaining the performance of the artificial venous valve to be tested. It should be noted that the first pressure curve P1, the second pressure curve P2, and the third pressure curve P3 are waveform curves that change periodically according to the operating cycle of the artificial venous valve to be tested. The period of the waveform curve is related to the opening and closing of the artificial venous valve to be tested, and is also related to the displacement period of the piston 41. For example, when the artificial venous valve to be tested is closed, the pressure on at least one side thereof increases. When the artificial venous valve to be tested is opened, the pressure difference between the two sides decreases sharply or even approaches zero.

[0061] In some embodiments, the piston 41 is retracted and moves away from the artificial venous valve to be tested (eg, toward the Figure 1 (moves to the right in the figure), the piston 41 provides negative pressure to the interior of the first liquid storage device 31. When the artificial venous valve to be tested is functioning normally, the artificial venous valve to be tested opens, and the test liquid enters the second test pipe 12 from the second liquid storage device 32, enters the pipe to be tested 2 through the second test pipe 12, enters the first test pipe 11 through the artificial venous valve to be tested in the pipe to be tested 2, and then enters the first liquid storage device 31.

[0062] In some embodiments, the piston 41 is extended and moves toward the artificial venous valve to be tested (for example, toward Figure 1(left movement in the figure), the piston 41 provides a first positive pressure to the interior of the first liquid storage device 31, so that the test liquid has a tendency to enter the first test pipeline 11 from the first liquid storage device 31 and further enter the pipeline 2 to be tested. When the artificial venous valve to be tested is working normally, the artificial venous valve to be tested is closed, and the test liquid is blocked by the artificial venous valve to be tested. Therefore, the test liquid can only enter the pressure-regulating pipeline 5 through the first liquid storage device 31 and further enter the second liquid storage device 32 for pressure relief.

[0063] Through the reciprocating motion of the piston 41, the artificial venous valve in the pipeline to be tested is periodically opened and closed to check the fatigue of the artificial venous valve to be tested, and the test liquid is passed through the artificial venous valve to be tested in the open state, or the test liquid applies pressure to the closed artificial venous valve to be tested to check whether the "one-way valve port" of the artificial venous valve to be tested is functioning normally and the impact resistance of the artificial venous valve.

[0064] In some embodiments, the artificial venous valve to be tested in the test pipe 2 may have a specific installation direction, and the installation direction of the artificial venous valve to be tested may be configured according to the flow direction of the test liquid. For example, the test liquid is moved in the first direction (for example, toward the test fluid) by a second positive pressure (similar to the first positive pressure). Figure 1 Left movement in the middle), a second direction (e.g. towards Figure 1 If the artificial venous valve to be tested moves in the second direction (rightward movement in the second direction), the artificial venous valve to be tested is configured to allow the test liquid moving in the second direction to pass through, and to prevent the test liquid moving in the first direction from flowing back. In this embodiment, the operating mode of the artificial venous valve to be tested is close to that in an actual working environment.

[0065] In some other embodiments, the artificial venous valve to be tested may also have the opposite installation direction.

[0066] The aforementioned positive pressure and negative pressure can be achieved by the reciprocating motion of the piston 41 relative to the first liquid storage device 31 .

[0067] In some embodiments, the test device for the artificial venous valve may further include a motor 42 , such as a linear motor, and the motor 42 drives the piston 41 to move, for example, the motor 42 drives the piston 41 to reciprocate.

[0068] Wherein, the pipe to be tested 2 can be a silicone tube or a biological blood vessel, and the liquid to be tested can be water, glutaraldehyde solution or formalin solution, etc. In some embodiments, the diameter of the pipe to be tested 2 can range from 2 to 30 mm, for example, 5 to 25 mm. Exemplarily, the diameter of the pipe to be tested 2 can be 2 mm, 2.5 mm, 5 mm, 6.8 mm, 10 mm, 12 mm, 18.8 mm, 24 mm, 28 mm, 30 mm. In some embodiments, the operating frequency of the piston 41 can range from 0 to 30 Hz, for example, 10 to 22 Hz. Exemplarily, the operating frequency of the piston 41 can be 0.1 Hz, 1 Hz, 1.5 Hz, 5 Hz, 8 Hz, 10 Hz, 15 Hz, 20 Hz, 22.5 Hz, 28 Hz, 30 Hz.

[0069] The pressure regulating pipe 5 is configured to connect the first liquid storage device 31 and the second liquid storage device 32. A portion of the test liquid can be transferred from the first liquid storage device 31 to the second liquid storage device 32 or from the second liquid storage device 32 to the first liquid storage device 31 via the pressure regulating pipe 5. The pressure regulating pipe 5 diverts the test liquid to adjust the pressure of the test liquid passing through the pipeline 2 to be tested.

[0070] The pressure-regulating pipeline 5 is provided with a flow control mechanism 51 for regulating the flow rate within the pressure-regulating pipeline 5. In some embodiments, the flow control mechanism 51 can be a flow-control valve, such as a throttle valve, specifically a ball valve or a gate valve, which functions to regulate the flow of the test liquid through the pressure-regulating pipeline 5. By adjusting the flow control mechanism 51, the flow rate of the test liquid within the pressure-regulating pipeline 5 is controlled, thereby adjusting the pressure of the test liquid entering the first test pipeline 11.

[0071] It should be noted that, first, the pressure-regulating pipe 5 allows the test liquid in the first liquid storage device 31 to escape from the first liquid storage device 31 when the artificial venous valve under test is closed, preventing excessive pressure from building up on the side of the artificial venous valve under test that is under pressure. Second, the pressure-regulating pipe 5 diverts the flow of test liquid in the first and second test pipes 11, 12 during the movement of the piston 41, thereby reducing the overall operating pressure within the first and second test pipes 11, 12 (and, of course, within the test pipe 2) during the test process. This prevents the entire system from operating in a high-pressure environment, ensuring a safe operating environment for the system and allowing the test pipe 2 and the test artificial venous valve to be tested to be tested at appropriate operating pressures. Third, because the pressure-regulating pipe 5 reduces the operating pressures in the first and second test pipes 11, 12, the first and second pressure curves P1, P2 have smaller amplitudes when acquired, making them easier to display, observe, and calculate.

[0072] One or more embodiments of the present specification may further include: a test liquid container 6 , which is connected to the second liquid storage device 32 , contains a test liquid, and is used to provide the test liquid to the second liquid storage device 32 .

[0073] One or more embodiments of the present specification may further include: an environmental simulation container, which is provided outside the pipeline 2 to simulate the working environment of the pipeline 2 to be tested, and includes a temperature control device.

[0074] In some embodiments, the pipe to be tested 2 is arranged inside an environmental simulation container, and the first test pipe 11 and the second test pipe 12 pass through the environmental simulation container and are detachably connected to both ends of the pipe to be tested 2. Exemplarily, the first test pipe 11 and the pipe to be tested 2, and the second test pipe 12 and the pipe to be tested 2 can be detachably connected via quick-change connectors. The environmental simulation container is specifically used to simulate the in vivo environment in which the pipe to be tested 2 works, for example, to simulate the in vivo blood environment, and / or to simulate the in vivo temperature, so that the test environment of the artificial venous valve to be tested is closer to the actual working environment, thereby obtaining more accurate test results. In addition, when the pipe to be tested 2 is selected as a biogenic blood vessel, the test environment will also have an impact on the biogenic blood vessel, such as affecting the contraction or relaxation of the biogenic blood vessel. Therefore, by simulating the in vivo environment, the biogenic blood vessel has a more stable working environment, thereby obtaining more accurate test results.

[0075] In some embodiments, the temperature control device for the environmental simulation container may include: a heating device 61 for heating the test liquid in the environmental simulation container, and a temperature sensor 62 for monitoring the temperature of the test liquid. The heating strategy of the heating device 61 is adjusted based on the data fed back by the temperature sensor 62, so that the temperature in the environmental simulation container reaches a set temperature or stabilizes within a certain range of the set temperature. In some embodiments, the temperature of the test liquid in the environmental simulation container may range from 0-42°C, for example, 35-40°C, or 36-38°C.

[0076] In some embodiments, the environmental simulation container can be provided by the test liquid container 6. For example, the environmental simulation container can be the test liquid container 6, or the environmental simulation container is a part of the test liquid container 6. In this embodiment, the test liquid container 6 is connected to the second liquid storage device 32 via a liquid supply pipe 63. The test liquid container 6 contains a test liquid at a first temperature, and the test liquid enters the second liquid storage device 32 from the test liquid container 6 to implement the test, or receives the test liquid from the second liquid storage device 32. At the same time, the pipeline 2 to be tested is immersed in the test liquid at the first temperature of the test liquid container 6 to achieve environmental simulation. The temperature of the test liquid is adjusted and maintained by the heating device 61 and the temperature sensor 62. In this embodiment, the liquid in the test liquid container 6 has both the function of testing and the function of environmental simulation.

[0077] In other embodiments, an environmental simulation container and a test liquid container may be included that are independent of each other. The environmental simulation container contains environmental simulation liquid, and the test liquid container contains test liquid. Exemplarily, the environmental simulation container includes a first temperature control device, which includes a first heating device and a first temperature sensor, so that the environmental simulation liquid is at the environmental simulation temperature, and the pipe 2 to be tested is immersed in the environmental simulation liquid at the environmental simulation temperature. Exemplarily, the test liquid container includes a second temperature control device, which includes a second heating device and a second temperature sensor, so that the test liquid is at the test temperature, and the test liquid container is connected to the second liquid storage device via a liquid supply pipe. In some embodiments, the environmental simulation liquid and the test liquid may be the same or different. In some embodiments, the environmental simulation temperature and the test temperature may be the same or different.

[0078] In one or more embodiments of the present specification, the first liquid storage device 31 may include a first liquid storage space and a second liquid storage space that are interconnected. The piston 41 is disposed within the second liquid storage space and reciprocates within the second liquid storage space. In some embodiments, the first liquid storage device 31 includes a first housing 311 and a second housing 312 that are fixedly connected. The first housing 311 provides the first liquid storage space, the second housing 312 provides the second liquid storage space, and the piston 41 reciprocates within the second housing 312.

[0079] In some embodiments, the second liquid storage device 32 includes a third housing 313. In some embodiments, the first housing 311, the second housing 312, and the third housing 313 are each secured to the base 104 via a bracket 103. The first housing 311, the second housing 312, and the third housing 313 can be cylindrical structures disposed transversely in the axial direction, and the bracket 103 has a semi-arc-shaped receiving surface that matches the lower surface of the cylindrical structure. In some embodiments, the bracket 103 and the first housing 311, the bracket 103 and the second housing 312, and the bracket 103 and the third housing 313 are fixedly connected via fasteners.

[0080] One or more embodiments of the present specification may also include: at least one of a first air cavity 71 and a second air cavity 72, the first air cavity 71 being directly or indirectly connected to the first test pipe 11, the first air cavity 71 being used to receive a portion of the test liquid from the first test pipe 11, and the first air cavity 71 being used to provide pressure-regulated gas in the direction of the first test pipe 11; the second air cavity 72 being directly or indirectly connected to the second test pipe 12, the second air cavity 72 being used to receive a portion of the test liquid from the second test pipe 12, and the second air cavity 72 being used to provide pressure-regulated gas in the direction of the second test pipe 12.

[0081] In some embodiments, the first air chamber 71 is disposed at the upper end of the first test pipe 11, and the second air chamber 72 is disposed at the upper end of the second test pipe 12. Both the first test pipe 11 and the second test pipe 12 are disposed horizontally. In some embodiments, the piston 41 moves in a horizontal or substantially horizontal direction. The direction in which the piston 41 applies positive or negative pressure to the test liquid is perpendicular or substantially perpendicular to the direction in which the air chamber provides pressure regulation to the test liquid. Therefore, the air chambers, such as the first air chamber 71 or the second air chamber 72, do not directly absorb the positive or negative pressure provided by the piston 41 (the air chambers are not disposed directly opposite the impact direction of the piston 41). Instead, they adjust the pressure within the pipes, such as the first test pipe 11 or the second test pipe 12, by absorbing the lateral positive or negative pressure of the test liquid.

[0082] At least one of the first air cavity 71 and the second air cavity 72 includes: a detachable interface 76 directly or indirectly connected to the first test pipe 11 or the second test pipe 12 , and a Luer connector 75 directly or indirectly connected to the gas source.

[0083] In some embodiments, the air cavity, such as the first air cavity 71 or the second air cavity 72, is directly connected to a test pipe, such as the first test pipe 11 or the second test pipe 12. In other embodiments, the air cavity, such as the first air cavity 71 or the second air cavity 72, is connected to a liquid storage device, such as the first liquid storage device 31 or the second liquid storage device 32, thereby indirectly connecting to the first test pipe 11 or the second test pipe 12.

[0084] The detachable interface 76 allows the air cavity, such as the first air cavity 71 or the second air cavity 72, to be easily detached from or connected to the connected structure, such as the first test pipe 11 or the second test pipe 12, so as to facilitate the adjustment or replacement of the air cavity according to actual needs. For example, in some test environments, the first air cavity 71 and / or the second air cavity 72 of different volumes can be replaced, or the first air cavity 71 and / or the second air cavity 72 of different cross-sectional areas can be replaced to adjust the pressure regulation effect. The pressure regulation effect includes but is not limited to adjusting the pressure regulation range, the pressure regulation response speed, etc., which can be achieved by adjusting the amount of gas (the capacity of the air cavity) and the pressure of the gas (adjusting the capacity and cross-sectional area of ​​the air cavity without adjusting the gas source).

[0085] In some embodiments, the Luer connector 75 is used to supply gas to a gas cavity, such as the first gas cavity 71 or the second gas cavity 72 (pre-supplied with gas before the device is operated, or further supplied with gas during operation). This allows multiple gas cavities of different shapes to be connected to the same gas pipeline (through which a gas source supplies gas to the gas cavity). This also facilitates adjustment or replacement of the gas cavity according to actual needs. In some embodiments, the gas source can be a gas storage device, such as a tank or storage tank, for storing gas. In some embodiments, the gas is stored in a compressed liquid form and the pressure is adjusted by a pressure regulating mechanism before being supplied to the gas cavity. In some embodiments, the gas provided by the gas source has a pressure greater than atmospheric pressure.

[0086] In some embodiments, a three-way valve capable of opening, closing, or switching the gas passage may be disposed between the Luer connector 75 and an air cavity, such as the first air cavity 71 or the second air cavity 72. In some embodiments, the three-way valve may include a first port connected to the air cavity, a second port connected to the Luer connector 75, and a third port that can be connected to an exhaust device. In some embodiments, a gas source provides gas to the air cavity via the second port and the first port. In some embodiments, gas within the air cavity may be exhausted via the first port and the third port to reduce the internal air pressure of the air cavity.

[0087] It should be noted that, first, the air cavity provides a buffering effect on pressure variations in the test fluid within the test tube. As previously described, based on the operating conditions of the artificial venous valve under test, the first and second pressure curves P1, P2 on either side can be obtained, and the pressure differential curve P3 can be calculated. The buffering effect provided by the air cavity reduces instantaneous pressure variations within the test tube. Parameter-wise, this tends to eliminate jagged edges in the first and second pressure curves P1, P2, facilitating the calculation of a more stable and smooth pressure differential curve P3, facilitating performance analysis. Second, by adjusting the amount of gas within the air cavity, the gas stiffness can be adjusted, thereby adjusting the buffering capacity and response speed to pressure variations in the test fluid. Increasing or decreasing the gas stiffness, as needed, increases or decreases (usually, decreases) the amplitude of individual jagged edges in the first and second pressure curves P1, P2, resulting in smoother first and second pressure curves P1, P2, without affecting the inherent trends of the first and second pressure curves P1, P2. (Excessive buffering capacity can affect the inherent trends of the pressure curves, in which case increasing the gas stiffness is necessary to reduce the buffering capacity.) Third, the air cavity cooperates with the pressure regulating pipe 5 to further reduce the working pressure of the first test pipe 11 and the second test pipe 12, so that when obtaining the first pressure curve P1 and the second pressure curve P2, the first pressure curve P1 and the second pressure curve P2 have smaller amplitudes, making it easier to display, observe and calculate.

[0088] In one or more embodiments of the present specification, the first test pipe 11 and the second test pipe 12 may both include: a tubular structure 81, the pipe structure 81 having a three-way structure 82, the three-way structure 82 having a first interface connected to the first liquid storage device 31 or the second liquid storage device 32, a second interface connected to the first air cavity 71 or the second air cavity 72, and a third interface connected to the pipe to be tested 2. In some embodiments, see Figures 1 to 5 As shown, the tubular structure 81 is arranged horizontally or approximately horizontally, the first interface is arranged downward, the second interface is arranged upward, and the third interface is arranged in a horizontal direction.

[0089] See also Figure 6 、 Figure 7 As shown, in one or more embodiments of the present specification, the first air cavity 71 and / or the second air cavity 72 may further include: an elastic membrane 73, the elastic membrane 73 separates the first air cavity 71 or the second air cavity 72 into a first accommodating space and a second accommodating space, and the first accommodating space is located on the upper side of the second accommodating space.

[0090] In some embodiments, the elastic membrane 73 is configured to be closed or open, with the outer edge of the elastic membrane 73 fixedly connected to the inner wall of the first air cavity 71 or the second air cavity 72. The elastic membrane 73 is used to adjust the stiffness of the gas within the air cavity. Compared to an air cavity without the elastic membrane 73, the air cavity with the elastic membrane 73 has a higher stiffness.

[0091] In some embodiments, see Figure 8 As shown, the elastic membrane 73 is in a closed configuration. The closed elastic membrane helps to prevent the test liquid and the pressure-regulated gas from mixing, and can also prevent the test liquid from erupting from the test pipe into the first accommodating space when suddenly pressurized, thereby affecting gas delivery.

[0092] In other embodiments, see Figure 9 As shown, the elastic membrane 73 is provided with a hole 74. For example, the elastic membrane 73 may have one hole 74. For example, the elastic membrane 73 may have multiple holes 74. Exemplarily, the holes 74 are arranged in a circular array. The holes 74 allow gas to flexibly flow from the first accommodation space into the second accommodation space in the presence of the elastic membrane 73, thereby achieving a wider pressure adjustment range. The elastic membrane 73 may also be used to adjust the stiffness in some situations.

[0093] In some cases, the pressure-regulated gas can be understood as a spring that applies elastic force to the test liquid. The elasticity of the spring can be adjusted by the gas pressure (specifically by adjusting the gas amount, volume, cross-sectional area, etc.) or by arranging the elastic membrane 73.

[0094] In some further embodiments, the elastic membrane 73 includes a first region and a second region. The first region is aligned with the detachable interface of the first air cavity 71 or the detachable interface of the second air cavity 72, and the hole 74 is defined in the second region. In this embodiment, the test liquid can be prevented from being ejected directly from the test pipe into the second accommodating space in the event of sudden pressure, while still retaining the advantages of a porous elastic membrane 73.

[0095] The test equipment shown in one or more embodiments of this specification may also include: a first pressure measuring device 91 provided on the first test pipe 11, and a second pressure measuring device 92 provided on the second test pipe 12. It should be noted that the first pressure measuring device 91 and the second pressure measuring device 92 are used to measure the static pressure in the corresponding test pipes. In some embodiments, static pressure refers to the pressure measured inside the test liquid that is not affected by the flow rate. It is the pressure generated by the irregular motion of the molecules of the test liquid hitting the wall of the test pipe. It is only related to the density of the test liquid and the acceleration of gravity. The static pressure is equal in all directions and is directed along the inner normal direction of the action surface.

[0096] Illustratively, the first test conduit 11 includes a first pressure tap for connecting to the first pressure measuring device 91, and the second test conduit 12 includes a second pressure tap for connecting to the second pressure measuring device 92. The distance between the first pressure tap and the first liquid storage device 31 can be greater than 5 to 15 times (e.g., 10 times) the diameter of the first test conduit 11, and the distance between the second pressure tap and the second liquid storage device 32 can be greater than 5 to 15 times (e.g., 10 times) the diameter of the second test conduit 12. Similarly, the distance between the first pressure tap and the artificial venous valve to be tested can be greater than 3 to 8 times (e.g., 5 times) the diameter of the first test conduit 11, and the distance between the second pressure tap and the artificial venous valve to be tested can be greater than 3 to 8 times (e.g., 5 times) the diameter of the second test conduit 12.

[0097] Based on the distance arrangement of the above-mentioned pressure measuring holes, such as the first pressure measuring hole or the second pressure measuring hole, relative to the liquid storage device, such as the first liquid storage device or the second liquid storage device, and the distance arrangement of the above-mentioned pressure measuring holes and the artificial venous valve to be tested, the dynamic pressure generated by the test liquid impacting the inner wall of the liquid storage device or impacting the artificial venous valve to be tested can be avoided, or the dynamic pressure generated by the eddy current generated at the connection between the liquid storage device and the test pipe or on one side of the artificial venous membrane to be tested can be avoided. In some embodiments, the dynamic pressure refers to the pressure generated by the kinetic energy per unit area of ​​the test liquid, and the dynamic pressure is related to the motion state of the test liquid. Since the test liquid has kinetic energy when it impacts or forms a eddy current, and the kinetic energy changes in real time, the measured pressure is unstable and has no reference value, which affects the calculation of the first pressure curve and the second pressure curve.

[0098] In some embodiments, the diameter of the first test pipe 11 may be equal to the diameter of the second test pipe 12 .

[0099] In some embodiments, the first pressure measuring device 91 is connected to the first pressure measuring hole via a first pressure measuring pipe 93, and the second pressure measuring device 92 is connected to the second pressure measuring hole via a second pressure measuring pipe 94. The apertures of the first and second pressure measuring holes can range from 1 to 6 mm, for example, from 3 to 5 mm. The length of the first pressure measuring pipe 93 can be greater than twice the diameter of the first pressure measuring hole, and the length of the second pressure measuring pipe 94 can be greater than twice the diameter of the second pressure measuring hole.

[0100] Based on the above-mentioned pressure measuring holes, such as the aperture arrangement of the first pressure measuring hole or the second pressure measuring hole, and the length arrangement of the first pressure measuring pipe 93 and the second pressure measuring pipe 94, it is possible to avoid the test liquid from generating eddies when passing through the first pressure measuring hole and the second pressure measuring hole. In view of the fact that there are additional pressures provided by kinetic energy in multiple directions when eddies are formed, which causes the measured pressure value to be too large or too small, affecting the measurement results, it is required that the first pressure measuring hole, the second pressure measuring hole, the first pressure measuring pipe 93, and the second pressure measuring pipe 94 be arranged so that no eddies are generated at the measuring positions of the first pressure measuring device 91 and the second pressure measuring device 92, and static pressure can be measured. Specifically, a smaller aperture setting makes it less likely that eddies will form, while a longer pressure measuring pipe away from the pipe branch further avoids the pressure measuring device from measuring the dynamic pressure at the eddies.

[0101] In one or more embodiments of this specification, see Figure 10 As shown, it can also include: a control module, the control module is connected to the motor signal, the control module is connected to the first pressure measuring device 91 and the second pressure measuring device 92 signal, the control module includes a wireless transmission module and a wired transmission module, and then realizes wired signal transmission or wireless signal transmission with the motor, the first pressure measuring device 91 and the second pressure measuring device 92. In some embodiments, the control module can calculate the pressure difference data based on the pressure data provided by the first pressure measuring device 91 and the second pressure measuring device 92, for example, the pressure difference curve P3 is calculated by the first pressure curve P1 and the second pressure curve P2. In some embodiments, during the test process, the control module can adjust the stroke of the motor 42 according to the pressure difference data to adjust the pressure difference to reach the set range or keep the pressure difference stable. In some embodiments, the control module can also be connected to the temperature control device such as the heating device 61 and the temperature sensor 62 signal, for receiving the temperature data provided by the temperature sensor 62, or for sending a temperature increase or decrease instruction to the heating device 61.

[0102] In some embodiments, see Figure 10 As shown, it also includes a controller 105 and a host computer 106 . The controller 105 provides the aforementioned control module, and the host computer 106 is used to display the first pressure curve P1 , the second pressure curve P2 , and the pressure difference curve P3 , or to send instructions to the controller 105 .

[0103] In one or more embodiments of this specification, see Figure 11 、 Figure 12 As shown, the second test pipe 12 may also be provided with a rectifier 101. Figure 14FIG. 1 shows a cross section of a rectifier 101. The rectifier 101 is disposed in the middle of the second test pipe 12 and divides the second test pipe 12 into two areas. The two areas are connected through a hole on the rectifier 101. The rectifier 101 allows the test liquid to pass through while providing a certain resistance to the passage of the test liquid. Specifically, the rectifier 101 is provided when the piston 41 moves toward the test pipe 12. Figure 11 The right side movement, the artificial venous valve to be tested opens, and the test fluid flows to Figure 11 The test liquid is allowed to pass through during the transportation to the right side of the piston 41. Figure 11 In the process of leftward movement, closure of the artificial venous valve to be tested, and inability of the test liquid to pass through, part of the test liquid that enters the second liquid storage device 32 through the pressure regulating pipe 5 and has a tendency to move to the right side of the second test pipe 12 is blocked as much as possible to avoid the test liquid from forming excessive pressure on the left side of the artificial venous valve to be tested and affecting the closure of the artificial venous valve to be tested.

[0104] See also Figure 11 、 Figure 13 As shown, a one-way valve 102 is provided on the pressure regulating pipe 5. By arranging the one-way valve 102, the piston 41 is Figure 11 During the right movement in the process, the test liquid can only pass through the pipe to be tested 2 and cannot pass through the pressure regulating pipe 5, thereby preventing the opening of the pressure regulating pipe 5 from affecting the test data (for example, causing the descending phase of the pressure waveform to slow down abnormally).

[0105] The beneficial effects that may be brought about by the embodiments of this specification include but are not limited to: (1) regulating the pressure on both sides of the artificial venous valve to be tested by the pressure regulating pipe, so as to avoid the entire device from operating under high pressure and thus avoid damage to the entire device. (2) jointly regulating the pressure on both sides of the artificial venous valve to be tested by the pressure regulating pipe and the first air cavity and the second air cavity, so that the amplitude of the pressure curve obtained is within a range that is easy to display and calculate. (3) providing a buffer for the test fluid by the first air cavity and the second air cavity, reducing the jaggedness of the pressure curve. (4) adjusting the stiffness of the pressure regulating gas provided by the first air cavity and the second air cavity by setting the elastic membrane. (5) preventing the test liquid from being sprayed into the air cavity and causing oscillation on the data of the test system, preventing the measured pressure from being greatly disturbed, and preventing the test liquid from mixing with the pressure regulating gas by setting the elastic membrane. (6) by setting the position of the hole on the elastic membrane, a large buffer adjustment range can still be achieved while minimizing the test liquid from being sprayed into the air cavity. (7) simulating the actual working environment of the test pipe and the artificial venous valve to be tested by the environmental simulation container. (8) By integrating the test liquid container and the environmental simulation container to reduce the number of equipment components, the entire system can be lightweight.

[0106] It should be noted that different embodiments may produce different beneficial effects. In different embodiments, the beneficial effects that may be produced may be any one or a combination of the above, or any other possible beneficial effects. The above only lists the beneficial effects of some embodiments of this specification. The beneficial effects of more technical features of the embodiments of this specification can be found in the relevant descriptions of the corresponding embodiments and are not listed here one by one.

[0107] While the basic concepts have been described above, it will be apparent to those skilled in the art that the detailed disclosure is merely illustrative and does not limit this specification. Although not explicitly stated herein, various modifications, improvements, and revisions to this specification may be made by those skilled in the art. Such modifications, improvements, and revisions are taught in this specification and remain within the spirit and scope of the exemplary embodiments of this specification.

Claims

1. A test device for an artificial venous valve, characterized in that: include: A first test pipe and a second test pipe, which are respectively connected to two ends of a pipe to be tested for arranging an artificial venous valve to be tested; a first liquid storage device, which provides a test liquid to the first test pipe or receives the test liquid from the first test pipe, and has a piston disposed therein, the piston increasing or decreasing the volume of the test liquid in the first liquid storage device by displacement; a second liquid storage device, which provides a test liquid to the second test pipe or receives a test liquid from the second test pipe; A pressure regulating pipeline, wherein the pressure regulating pipeline connects the first liquid storage device and the second liquid storage device, and the pressure regulating pipeline is provided with a flow control mechanism for regulating the internal flow of the pressure regulating pipeline.

2. The test device for artificial venous valve according to claim 1, characterized in that: Also includes: A test liquid container is connected to the second liquid storage device.

3. The test device for artificial venous valve according to claim 2, characterized in that: Also includes: An environmental simulation container is provided outside the pipeline to be tested and is used to simulate the working environment of the pipeline to be tested. The environmental simulation container includes a temperature control device.

4. The test device for artificial venous valve according to claim 3, characterized in that: The environmental simulation container is provided by the test liquid container.

5. The test device for artificial venous valve according to claim 1 or 2, characterized in that: Also includes: a first air cavity, directly or indirectly connected to the first test pipe, for receiving a portion of the test liquid from the first test pipe and for providing pressure-regulated gas in the direction of the first test pipe; and / or The second air cavity is directly or indirectly connected to the second test pipe, and is used for receiving a portion of the test liquid from the second test pipe and for providing pressure-regulated gas in the direction of the second test pipe.

6. The test device for artificial venous valve according to claim 5, characterized in that: At least one of the first air cavity and the second air cavity comprises: a detachable interface directly or indirectly connected to the first test pipe or the second test pipe; A Luer connector that is connected directly or indirectly to a gas source.

7. The test device for artificial venous valve according to claim 5, characterized in that: The first test pipeline and the second test pipeline both include: The tubular structure has a three-way structure, and the three-way structure has a first interface connected to the first liquid storage device or the second liquid storage device, a second interface connected to the first air cavity or the second air cavity, and a third interface connected to the pipeline to be tested.

8. The test device for artificial venous valve according to claim 5, characterized in that: The first air cavity and / or the second air cavity further comprises: An elastic membrane separates the first air cavity or the second air cavity into a first accommodating space and a second accommodating space, wherein the first accommodating space is located above the second accommodating space.

9. The artificial venous valve testing device according to claim 8, characterized in that: The elastic film is provided with holes.

10. The artificial venous valve testing device according to claim 9, characterized in that: The elastic membrane includes a first region and a second region; At least one of the first air cavity and the second air cavity includes a detachable interface directly or indirectly connected to the first test pipe or the second test pipe, the first area is opposite to the detachable interface, and the hole is opened in the second area.

11. The artificial venous valve testing device according to claim 9, characterized in that: include: A first pressure measuring device is provided on the first test pipe, and a second pressure measuring device is provided on the second test pipe.

12. The test device for artificial venous valve according to claim 1, characterized in that: The second testing pipe is provided with a rectifier.

13. The test device for artificial venous valve according to claim 1, characterized in that: A one-way valve is provided on the pressure regulating pipeline.

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