CN109172047B - Prosthetic heart valve function test system - Google Patents
Prosthetic heart valve function test system Download PDFInfo
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- CN109172047B CN109172047B CN201811087517.3A CN201811087517A CN109172047B CN 109172047 B CN109172047 B CN 109172047B CN 201811087517 A CN201811087517 A CN 201811087517A CN 109172047 B CN109172047 B CN 109172047B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2472—Devices for testing
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- External Artificial Organs (AREA)
Abstract
The invention provides a function test system of a heart valve prosthesis, which comprises a human body simulation test mechanism, a monitoring mechanism and a control mechanism, wherein the human body simulation test mechanism comprises a heart simulation pump and a blood circulation simulation loop, the control mechanism is connected with the monitoring mechanism and the heart simulation pump, and the monitoring mechanism is also connected with the heart simulation pump and the blood circulation simulation loop. The artificial heart valve function test system provided by the invention can simulate the real human physiological environment, improves the scientificity and accuracy of the test, has high accuracy of the test, and can meet the valve test requirements under different test environments.
Description
Technical Field
The invention relates to the technical field of testing the hydrodynamic performance of a prosthetic heart valve, in particular to a prosthetic heart valve function testing system.
Background
Heart valve disease is a common heart disease, and the incidence of this disease is increasing with the prolongation of human life and aging of the population. Heart valve disease is irreversible and only progressively aggravated, and prosthetic heart valve replacement surgery is an effective method of treating severe heart valve disease. More than 30 tens of thousands of patients need valve surgery each year, accounting for the first place of heart surgery in adults. Whether mechanical or biological valves are used prior to clinical application, stringent in vitro, animal and clinical tests are required. The in vitro test is an important content of the performance evaluation of the artificial heart valve, and aims to obtain the performance parameters of the valve, evaluate the quality of the valve and provide a basis for the performance optimization of the valve. Among them, the in vitro functional test of the artificial heart valve is an important means for evaluating the hydrodynamic performance of the valve.
At present, artificial heart valve function test equipment which is independently developed in China is used, a traditional simple design method is adopted, only the principle is considered when the psychological environment is simulated, the cardiovascular structure of a human body is not considered, the device is unstable in operation, unreliable in performance, inaccurate in parameter control and complex in operation. The foreign imported equipment has stable performance but high price, so that the research and development cost of the valve is high, and the research and development and popularization of the valve are not facilitated.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides the artificial heart valve function test system which can simulate the real physiological environment of a human body, improves the scientificity and the accuracy of the test, has high blog precision and can meet the valve test requirements under different test environments.
In order to achieve the above object, the present invention provides a system for testing the function of a prosthetic heart valve, comprising a human body simulation test mechanism, a monitoring mechanism and a control mechanism, wherein the human body simulation test mechanism comprises a heart simulation pump and a blood circulation simulation loop, the control mechanism is connected with the monitoring mechanism and the heart simulation pump, and the monitoring mechanism is also connected with the heart simulation pump and the blood circulation simulation loop;
the blood circulation simulation loop comprises a ventricular cavity, a shunt block, an aortic stent, a valve mounting table, an aortic cavity, a first flow guide pipe, a second flow guide pipe, a damping valve, an atrial cavity, a one-way mechanical valve and a compliance cavity; the heart simulating pump is connected to one side of the ventricular cavity, the shunt block is fixed to the top of the ventricular cavity, and a first channel for conducting the ventricular cavity and the shunt block is formed by the bottom surface of the shunt block and the top surface of the ventricular cavity; the aortic stent and the atrial chamber are respectively fixed on two sides of the top surface of the shunt block, a second channel for conducting the atrial chamber and the shunt block is formed between the atrial chamber and the shunt block, and the one-way mechanical valve is arranged on the second channel; the valve mounting table is fixed on the top of the aortic support, the aortic cavity is fixed on the top of the valve mounting table, a third channel which conducts the aortic cavity and the shunt block is formed between the aortic support and the shunt block through the valve mounting table, the valve mounting table comprises a valve mounting frame, and the valve mounting frame is detachably fixed on the third channel; the lower part of the aortic cavity is communicated with the atrial cavity through the first guide pipe, and the damping valve is arranged on the first guide pipe; an upper portion of the aortic lumen communicates with the compliant lumen through the second flow conduit.
Preferably, the heart simulation pump comprises a shell, an alternating current servo motor, a screw pushing cylinder, a piston and a cylinder body, wherein the cylinder body and the alternating current servo motor are fixed in the shell, the screw pushing cylinder is in transmission connection with the alternating current servo motor, and the piston is fixed at one end of the screw pushing cylinder far away from the alternating current servo motor and can be matched with the piston on the inner wall of the cylinder body in a reciprocating manner along the transmission direction of the screw pushing cylinder; one end of the cylinder body, which is far away from the alternating current servo motor, is communicated with the ventricular cavity.
Preferably, the transmission direction of the screw pushing cylinder is a horizontal direction, and the cylinder body and the screw pushing cylinder are coaxially arranged.
Preferably, the monitoring mechanism comprises a temperature control device, a flowmeter, at least one flow sensor, a signal amplifier, a first pressure sensor, a second pressure sensor and a plurality of displacement sensors; the temperature control device is connected with the blood circulation simulation loop; the flowmeter is connected with the flow sensor, and the flow sensor is arranged in the third channel between the aortic stent and the shunt block; the signal amplifier is connected with the first pressure sensor and the second pressure sensor, the first pressure sensor is arranged on the shunt block, and the second pressure sensor is arranged in the aortic cavity; the flowmeter and the signal amplifier are connected with the control mechanism; the displacement sensor is arranged on the screw rod pushing cylinder and is connected with the control mechanism.
Preferably, the control mechanism comprises an alternating current servo controller, a data acquisition card and an upper computer, wherein the upper computer is connected with the data acquisition card, the data acquisition card is connected with the alternating current servo controller, the flowmeter, the signal amplifier and the displacement sensor, and the alternating current servo controller is connected with the alternating current servo motor.
Preferably, the split block forms a split cavity along the horizontal direction, two ends of the split cavity form an opening respectively, and the openings are respectively provided with a sealing end cover.
Preferably, the aortic stent and the atrial chamber are arranged on two sides of the top of the shunt block along the axial direction of the shunt chamber and symmetrically arranged on two sides of the first channel.
Preferably, the bottom of the chamber forms a drain port provided with a drain cap.
Preferably, the atrial chamber is made of a transparent material.
The invention adopts the technical proposal, which has the following beneficial effects:
the human body simulation test mechanism can simulate the human body physiological environment comprehensively considering the conditions of heart structure, blood circulation environment, damping, compliance and the like, simulate the real human body physiological environment and improve the scientificity and accuracy of the test. By matching the human body simulation test mechanism, the monitoring mechanism and the control mechanism, the automatic artificial heart valve function test can be realized. The damping valve is used for adjusting the resistance in the blood circulation simulation process, and improving the simulation degree of human body environment, so that the accuracy of the test result is improved. The compliance cavity is used for adjusting the compliance of the system by changing the air volume above the liquid level in the compliance cavity, simulating the real physiological environment and improving the precision of the test result. The valve mounting frame is detachably fixed on the third channel, and measurement of the prosthetic heart valve to be measured with different specifications can be met by replacing the valve mounting frames with different models. The atrial chamber is made of transparent materials, so that the open and closed states and the movement conditions of the artificial heart valve to be detected can be conveniently and intuitively observed.
Drawings
FIG. 1 is a schematic diagram of a prosthetic heart valve function testing system in accordance with an embodiment of the present invention;
FIG. 2 is a schematic diagram of a prosthetic heart valve functional testing system in accordance with an embodiment of the present invention;
FIG. 3 is a schematic diagram of a blood circulation simulation circuit according to an embodiment of the present invention;
fig. 4 is a schematic diagram of a heart simulation pump according to an embodiment of the present invention.
Detailed Description
The following description of the preferred embodiments of the present invention will be given with reference to fig. 1 to 4, so that the functions and features of the present invention can be better understood.
Referring to fig. 1 and 2, a system for testing functions of a prosthetic heart valve according to an embodiment of the present invention includes a human body simulation test mechanism 1, a monitoring mechanism 2 and a control mechanism 3, wherein the human body simulation test mechanism 1 includes a heart simulation pump 11 and a blood circulation simulation loop 12, the control mechanism 3 is connected to the monitoring mechanism 2 and the heart simulation pump 11, and the monitoring mechanism 2 is further connected to the heart simulation pump 11 and the blood circulation simulation loop 12.
The human body simulation test mechanism 1 can simulate the physiological environment of a human body by comprehensively considering the conditions of heart structure, blood circulation environment, damping, compliance and the like, simulate the real physiological environment of the human body and improve the scientificity and accuracy of the test. By matching the human body simulation test mechanism 1, the monitoring mechanism 2 and the control mechanism 3, the automatic artificial heart valve function test can be realized.
In this embodiment, the heart simulation pump 11 has a position closed-loop control function, and has high accuracy of the pulsations, so as to meet the valve testing requirements under different testing environments.
Referring to fig. 2 and 3, the blood circulation simulation circuit 12 includes a ventricular chamber 1201, a shunt block 1202, an aortic stent 1203, a valve mount 1204, an aortic chamber 1205, a first flow guide 1206, a second flow guide 1207, a damping valve 1208, an atrial chamber 1209, a one-way mechanical valve 1210, and a compliance chamber 1211; one side of the ventricular chamber 1201 is connected with the heart simulation pump 11, the shunt block 1202 is fixed on the top of the ventricular chamber 1201, and a first channel for conducting the ventricular chamber 1201 and the shunt block 1202 is formed by the bottom surface of the shunt block 1202 and the top surface of the ventricular chamber 1201; the aortic stent 1203 and the atrial chamber 1209 are respectively fixed on two sides of the top surface of the shunt block 1202, a second channel for conducting the atrial chamber 1209 and the shunt block 1202 is formed between the atrial chamber 1209 and the shunt block 1202, and the unidirectional mechanical valve 1210 is arranged on the second channel; the valve mounting table 1204 is fixed on top of the aortic stent 1203, the aortic lumen 1205 is fixed on top of the valve mounting table 1204, the aortic lumen 1205 forms a third channel for conducting the aortic lumen 1205 and the shunt block 1202 between the valve mounting table 1204 and the aortic stent 1203 and the shunt block 1202, the valve mounting table 1204 comprises a valve mounting frame 12041, and the valve mounting frame 12041 is detachably fixed on the third channel; the lower part of the aortic cavity 1205 is communicated with the atrial cavity 1209 through a first guide pipe 1206, and a damping valve 1208 is arranged on the first guide pipe 1206; the upper portion of the aortic lumen 1205 is in communication with the compliant chamber 1211 through a second flow conduit 1207.
The damping valve 1208 is used for adjusting the resistance in the blood circulation simulation process and improving the simulation degree of the human body environment, so that the accuracy of the test result is improved. The compliance chamber 1211 is used to simulate a real physiological environment by varying the volume of air above the fluid level within the compliance chamber 1211, regulating the compliance of the system, and improving the accuracy of the test results. In this embodiment, the compliance cavity 1211 is secured to the heart simulating pump 11. The valve mounting frame 12041 is detachably fixed on the third channel, and the measurement of the prosthetic heart valve 4 to be measured with different specifications can be satisfied by replacing the valve mounting frame 12041 with a different model.
In this embodiment, the split block 1202 forms a split cavity along the horizontal direction, two ends of the split cavity form an opening respectively, and the openings are provided with a sealing end cap 1212 respectively.
The aortic stent support 1203 and the atrial chamber 1209 are disposed on both sides of the top of the shunt block 1202 in the axial direction of the shunt chamber and symmetrically disposed on both sides of the first channel.
The bottom of the chamber 1201 forms a drain opening provided with a drain cap 1213. The atrial chamber 1209 is made of a transparent material, and in this embodiment, the transparent material is made of a transparent sub-force gram, so that the open/close state and the movement condition of the prosthetic heart valve 4 to be tested can be conveniently and intuitively observed.
Referring to fig. 2 and 4, the heart-simulating pump 11 includes a housing 111, an ac servo motor 112, a screw pushing cylinder 113, a piston 114 and a cylinder 115, wherein the cylinder 115 and the ac servo motor 112 are fixed in the housing 111, the screw pushing cylinder 113 is in transmission connection with the ac servo motor 112, and the piston 114 is fixed at one end of the screw pushing cylinder 113 away from the ac servo motor 112 and is reciprocally matched with the piston 114 on the inner wall of the cylinder 115 along the transmission direction of the screw pushing cylinder 113; the end of cylinder 115 remote from ac servo motor 112 is in communication with ventricular chamber 1201.
The transmission direction of the screw pushing cylinder 113 is a horizontal direction, and the cylinder body 115 and the screw pushing cylinder 113 are coaxially arranged.
In this embodiment, the monitoring mechanism 2 includes a temperature control device 21, a flowmeter 22, at least one flow sensor 23, a signal amplifier 24, a first pressure sensor 25, a second pressure sensor 26 and a plurality of displacement sensors 27; the temperature control device 21 is connected with the blood circulation simulation loop 12; the flow meter 22 is connected with the flow sensor 23, and the flow sensor 23 is arranged in a third channel between the aortic stent 1203 and the split flow block 1202; the signal amplifier 24 is connected with a first pressure sensor 25 and a second pressure sensor 26, the first pressure sensor 25 is arranged on the shunt block 1202, and the second pressure sensor 26 is arranged on the aortic cavity 1205; the flowmeter 22 and the signal amplifier 24 are connected with the control mechanism 3; the displacement sensor 27 is mounted on the screw pushing cylinder 113 and is connected to the control mechanism 3.
In addition, the control mechanism 3 includes an ac servo controller 31, a data acquisition card 32 and a host computer 33, the host computer 33 is connected with the data acquisition card 32, the data acquisition card 32 is connected with the ac servo controller 31, the flowmeter 22, the signal amplifier 24 and the displacement sensor 27, and the ac servo controller 31 is connected with the ac servo motor 112. In this embodiment, the data acquisition card 32 includes an I/O module and a data acquisition module, and the host computer 33 sends instructions to the I/O module of the data acquisition card 32 through the USB bus, and then the pulse output port of the I/O module sends pulse data to the ac servo controller 31, so as to control the reciprocating motion of the heart simulating pump 11. Meanwhile, the frequency and the number of pulse outputs can be set by the upper computer 33, and the pulsation frequency and the pulsation amount of the heart simulating pump 11 can be accurately controlled.
Referring to fig. 2 to 4, an operation method of a prosthetic heart valve function test system according to an embodiment of the present invention is as follows:
firstly, the prosthetic heart valve 4 to be tested is fixed on the valve mounting frame 12041, and then the blood simulation liquid 5 is injected through a liquid injection port formed at the upper end of the atrium cavity 1209, and the blood simulation liquid 5 fills the cavity of the whole blood circulation simulation circuit 12 because the blood circulation simulation circuit 12 is in a communicated state. The fill port is then sealed with an end cap. Then, a temperature environment similar to that of a human body is simulated by the temperature control device 21, and the blood simulation solution 5 is maintained at 37 ℃.
Then, the power supply (not shown) is turned on, and the medical three-way valve can be used to perform pressure calibration on the first pressure sensor 25 and the second pressure sensor 26 by communicating with the atmosphere before testing. After calibrating the pressure, the first pressure sensor 25 and the second pressure sensor 26 can be put in communication with the blood circulation simulation circuit 12 by switching the three-way valve. The heart simulation pump 11 is started by the upper computer 33, whether the lead screw pushing cylinder 113 is at the preset origin position or not is observed by the displacement sensor 27, then a test is started, and the piston 114 directly applies force to the blood simulation liquid 5 under the action of the heart simulation pump 11. When the piston 114 moves forwards to simulate the diastole, the blood simulation liquid 5 transmits the load to the artificial heart valve 4 to be tested, so that the artificial heart valve 4 to be tested is opened, the one-way mechanical valve 1210 is closed, the blood simulation liquid 5 is pumped out of the ventricular chamber 1201, enters the aortic chamber 1205 through the artificial heart valve 4 to be tested, and flows into the atrial chamber 1209 through the first guide pipe 1206 and the damping valve 1208; when the piston 114 moves backward, the ventricular chamber 1201 is reduced in pressure, the prosthetic heart valve 4 to be measured is closed, the one-way mechanical valve 1210 is opened, and the blood-simulating fluid 5 flows back from the atrial chamber 1209 to the ventricular chamber 1201. After the test is completed, the drain end cap 1213 at the lower end of the ventricular chamber 1201 is opened to drain the blood simulation liquid 5.
The flow sensor 23, the flowmeter 22, the first pressure sensor 25 and the second pressure sensor 26 can monitor the hydrodynamic performance of the prosthetic heart valve 4 to be tested in real time; the data acquisition module of the data acquisition card 32 acquires the voltage signal processed by the signal amplifier 24 and the signal of the flowmeter 22, and can be displayed in a curve and data form on the upper computer 33, and the data required by aortic pressure, ventricular pressure, average valve-crossing pressure difference, blood flow and return flow, effective opening area and the like can be measured through calculation processing.
The artificial heart valve function test system provided by the embodiment of the invention has the advantages that the test result is accurate, the cardiovascular structure is optimally simulated, the physiological environment of the valve is reproduced in principle and morphology, the test error can be reduced, and the accuracy of the test result is improved.
The present invention has been described in detail with reference to the embodiments of the drawings, and those skilled in the art can make various modifications to the invention based on the above description. Accordingly, certain details of the illustrated embodiments are not to be taken as limiting the invention, which is defined by the appended claims.
Claims (9)
1. The artificial heart valve function test system is characterized by comprising a human body simulation test mechanism, a monitoring mechanism and a control mechanism, wherein the human body simulation test mechanism comprises a heart simulation pump and a blood circulation simulation loop, the control mechanism is connected with the monitoring mechanism and the heart simulation pump, and the monitoring mechanism is also connected with the heart simulation pump and the blood circulation simulation loop;
the blood circulation simulation loop comprises a ventricular cavity, a shunt block, an aortic stent, a valve mounting table, an aortic cavity, a first flow guide pipe, a second flow guide pipe, a damping valve, an atrial cavity, a one-way mechanical valve and a compliance cavity; the heart simulating pump is connected to one side of the ventricular cavity, the shunt block is fixed to the top of the ventricular cavity, and a first channel for conducting the ventricular cavity and the shunt block is formed by the bottom surface of the shunt block and the top surface of the ventricular cavity; the aortic stent and the atrial chamber are respectively fixed on two sides of the top surface of the shunt block, a second channel for conducting the atrial chamber and the shunt block is formed between the atrial chamber and the shunt block, and the one-way mechanical valve is arranged on the second channel; the valve mounting table is fixed on the top of the aortic support, the aortic cavity is fixed on the top of the valve mounting table, a third channel which conducts the aortic cavity and the shunt block is formed between the aortic support and the shunt block through the valve mounting table, the valve mounting table comprises a valve mounting frame, and the valve mounting frame is detachably fixed on the third channel; the lower part of the aortic cavity is communicated with the atrial cavity through the first guide pipe, and the damping valve is arranged on the first guide pipe; an upper portion of the aortic lumen communicates with the compliant lumen through the second flow conduit.
2. The prosthetic heart valve function test system of claim 1, wherein the heart simulating pump comprises a housing, an ac servo motor, a lead screw pushing cylinder, a piston and a cylinder, the cylinder and the ac servo motor being fixed within the housing, the lead screw pushing cylinder being in driving connection with the ac servo motor, the piston being fixed at an end of the lead screw pushing cylinder remote from the ac servo motor and reciprocally coupled with the piston of the cylinder inner wall in a driving direction of the lead screw pushing cylinder; one end of the cylinder body, which is far away from the alternating current servo motor, is communicated with the ventricular cavity.
3. The prosthetic heart valve function testing system of claim 2, wherein the lead screw pushing cylinder drive direction is horizontal and the cylinder body is coaxially disposed with the lead screw pushing cylinder.
4. The prosthetic heart valve function testing system of claim 2 or 3, wherein the monitoring mechanism comprises a temperature control device, a flow meter, at least one flow sensor, a signal amplifier, a first pressure sensor, a second pressure sensor, and a plurality of displacement sensors; the temperature control device is connected with the blood circulation simulation loop; the flowmeter is connected with the flow sensor, and the flow sensor is arranged in the third channel between the aortic stent and the shunt block; the signal amplifier is connected with the first pressure sensor and the second pressure sensor, the first pressure sensor is arranged on the shunt block, and the second pressure sensor is arranged in the aortic cavity; the flowmeter and the signal amplifier are connected with the control mechanism; the displacement sensor is arranged on the screw rod pushing cylinder and is connected with the control mechanism.
5. The prosthetic heart valve function test system of claim 4, wherein the control mechanism comprises an ac servo controller, a data acquisition card and a host computer, the host computer is connected to the data acquisition card, the data acquisition card is connected to the ac servo controller, the flow meter, the signal amplifier and the displacement sensor, and the ac servo controller is connected to the ac servo motor.
6. The system of claim 5, wherein the diverter block defines a diverter chamber in a horizontal direction, wherein each of the diverter chamber defines an opening at each end, and wherein each of the openings is provided with a sealing end cap.
7. The prosthetic heart valve function testing system of claim 6, wherein the aortic stent and the atrial chamber are disposed on top of the shunt block on both sides and symmetrically disposed on both sides of the first channel along an axial direction of the shunt chamber.
8. The prosthetic heart valve function testing system of claim 7, wherein the bottom of the ventricular chamber defines a drain opening, the drain opening being provided with a drain cap.
9. The prosthetic heart valve function testing system of claim 8, wherein the atrial chamber is formed of a transparent material.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201811087517.3A CN109172047B (en) | 2018-09-18 | 2018-09-18 | Prosthetic heart valve function test system |
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| CN201811087517.3A CN109172047B (en) | 2018-09-18 | 2018-09-18 | Prosthetic heart valve function test system |
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| CN109172047A CN109172047A (en) | 2019-01-11 |
| CN109172047B true CN109172047B (en) | 2023-09-15 |
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| CN201811087517.3A Active CN109172047B (en) | 2018-09-18 | 2018-09-18 | Prosthetic heart valve function test system |
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| CN111789700B (en) * | 2020-06-30 | 2022-10-25 | 成都赛拉诺医疗科技有限公司 | Valve function testing device |
| CN114005344B (en) * | 2021-11-29 | 2023-04-25 | 江苏大学 | Multifunctional combined simulation circulation experiment table |
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