CN215954616U - Instrument testing system - Google Patents
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- CN215954616U CN215954616U CN202121565775.5U CN202121565775U CN215954616U CN 215954616 U CN215954616 U CN 215954616U CN 202121565775 U CN202121565775 U CN 202121565775U CN 215954616 U CN215954616 U CN 215954616U
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Abstract
The utility model relates to an instrument testing system, which comprises an in-vitro simulation unit, a detection unit and a control unit, wherein: the in-vitro simulation unit comprises a heart simulation device, a simulation blood vessel communicated with a loop of the heart simulation device, and an inflow check valve and an outflow check valve which are respectively arranged on an inflow end and an outflow end of the simulation blood vessel, wherein the simulation blood vessel comprises a simulation test part; the detection unit includes a bubble detector for detecting bubbles in the simulation test part; the control unit comprises a controller, the heart simulator is connected with the controller, and the controller is used for controlling the pulse cycle of the heart simulator. The utility model aims to provide an automatic instrument testing system which is efficient and reliable in testing result.
Description
Technical Field
The utility model relates to the technical field of interventional medical instruments, in particular to an instrument testing system.
Background
A catheter intervention implant instrument system belongs to a third class of medical instruments, and is characterized in that an instrument system with a preloaded implant is punctured into a blood vessel in a catheter intervention mode, and the implant in the instrument system is conveyed to a lesion part through a blood vessel channel, so that the target tissue part is prevented or treated with lesions. Wherein, the implant in the instrument system is generally a super elastic instrument, and is assembled in the delivery device of the instrument system in a preloading mode after being compressed, so that a certain fit clearance exists between the implant and the inner cavity of the delivery device, and the fit clearance can be filled with air. Before the instrument system is used clinically, a doctor needs to inject physiological saline into the implant instrument system so as to fully exhaust air in a gap between an implant and a cavity of a conveyor and simultaneously infiltrate the implant instrument. When a doctor uses the apparatus system in the cardiovascular system of a human body, air bubbles are prevented from being introduced into the cardiovascular system of the human body as much as possible in the using process so as to prevent the air embolism of a blood circulation system (the air embolism means that air enters the cardiovascular system (artery or vein) by mistake and blocks the far end of the blood vessel along with the flow of blood to cause embolism, so that a series of pathological changes caused by ischemia and anoxia of local tissues are caused, and the disease is also called as air embolism. The air embolism can completely interrupt the effective blood circulation, so that the body has the condition of ischemia and hypoxia, and finally, the patient has permanent injury and even acute sudden death. Therefore, during the design process of the catheter intervention implant instrument system, a researcher needs to test the designed instrument system preloaded with the implant, so as to evaluate the safety of the implant instrument system according to the test result and further optimize the instrument system design scheme according to the test result.
However, in the current research and development iteration process of the catheter intervention implant instrument system product, an automatic testing system and method for generating bubbles in the simulation use of the instrument system are still blank. Although the simulated release test of the instrument system can be simply carried out in the test system for simulating the blood flow condition, the whole process is that the implant is observed by naked eyes in the simulated release process, the number of generated bubbles is manually recorded, and the artificial mode has visual errors, so that the bubbles with small diameters can not be identified, the accuracy of an observation result is seriously influenced, and the accurate number and the accurate diameter of the bubbles can not be tested, therefore, a system which can accurately and effectively carry out the automatic test is urgently needed to be developed.
SUMMERY OF THE UTILITY MODEL
Based on the above, the utility model provides an automatic instrument testing system which is efficient and reliable in testing result.
Apparatus test system, including external analog unit, detecting element and the control unit, wherein:
the in-vitro simulation unit comprises a heart simulation device, a simulation blood vessel communicated with a loop of the heart simulation device, and an inflow check valve and an outflow check valve which are respectively arranged on an inflow end and an outflow end of the simulation blood vessel, wherein the simulation blood vessel comprises a simulation test part;
the detection unit includes a bubble detector for detecting bubbles in the simulation test part;
the control unit comprises a controller, the heart simulator is connected with the controller, and the controller is used for controlling the pulse cycle of the heart simulator.
In one embodiment, the inflow check valve and/or the outflow check valve is configured as an inflow cusp valve and/or an outflow cusp valve having a valve-like structure.
In one embodiment, the in vitro simulation unit further comprises a monitoring subunit arranged on the simulated blood vessel flow path, and the monitoring subunit is connected with the controller; the monitoring subunit is used for monitoring circulation information on the simulated blood vessel and transmitting the circulation information to the controller, and the controller is also used for controlling the pulse cycle of the heart simulation device according to the circulation information.
In one embodiment, the monitoring subunit comprises a pressure sensor arranged on the simulated blood vessel, and the pressure sensor is connected with the controller; the pressure sensor is used for collecting pressure information on the simulated blood vessel and transmitting the pressure information to the controller, and the controller is used for adjusting the pulse cycle of the heart simulation device according to the pressure information; and/or the presence of a gas in the gas,
the monitoring subunit comprises a flow sensor arranged on the simulated blood vessel, and the flow sensor is connected with the controller; the flow sensor is used for collecting flow information flowing through the simulated blood vessel and transmitting the flow information to the controller, and the controller is used for adjusting the pulse period of the heart simulation device according to the flow information.
In one embodiment, the monitoring subunit is disposed upstream and near the simulation test portion.
In one embodiment, the extracorporeal simulation unit further comprises a constant temperature subunit arranged on the flow path of the simulated blood vessel, and the constant temperature subunit is used for enabling the temperature of the liquid in the simulated blood vessel to be in a certain temperature range.
In one embodiment, the constant temperature subunit comprises a confluence cavity communicated with the simulated blood vessel, and a temperature sensor and a heating device which are arranged in the confluence cavity, wherein the temperature sensor and the heating device are both connected with the controller; the temperature sensor is used for collecting the temperature of the liquid and transmitting the temperature information to the controller, and the controller is used for controlling the heating device to be opened or closed according to the temperature information.
In one embodiment, the temperature range is 37 ± 2 ℃.
In one embodiment, the control unit further comprises a control panel connected to the controller;
the bubble detector is connected with the controller, the bubble detector is used for sending bubble detection information to the controller, and the control panel is used for visually displaying the bubble detection information received by the controller.
In one embodiment, the heart simulator comprises a simulated heart pulsation pump, and/or the bubble detector comprises an ultrasound bubble counter.
The instrument testing system provided by the utility model establishes a simulation environment in vitro, performs simulated release in the simulation environment, and performs automatic detection through the bubble detector in the release process, so that the diameter and the quantity of bubbles generated by the implant instrument system in the simulated use process are efficiently and accurately detected, the whole process is simple and convenient, the precision is high, the test result is closer to clinical conditions, and the risk assessment is more sufficient.
Drawings
FIG. 1 is a system diagram of an exemplary instrument testing system of the present invention;
FIG. 2 is a schematic cross-sectional view of a closed cusp valve having a valve-like configuration in an exemplary instrumentation system of the present invention;
FIG. 3 is a schematic cross-sectional view of an open cusp valve having a valve-like configuration in an exemplary instrumentation system of the present invention.
Detailed Description
Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the utility model are shown in the drawings, it should be understood that the utility model can be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the utility model to those skilled in the art, and are not intended to be limiting.
Referring to fig. 1, the present invention exemplarily provides an instrument testing system 100 including an in vitro simulation unit 10, a detection unit 20, and a control unit 30. The in-vitro simulation environment is established through the in-vitro simulation unit 10, then, the device sample A to be tested is punctured into the simulated blood vessel 12 in the in-vitro simulation environment to release the implant in the sample, bubbles are generated in the simulated blood vessel 12 in the release process, meanwhile, the detection unit 20 detects the generated bubbles and obtains bubble information, and the whole system is controlled through the control unit 30. By the aid of the instrument testing system, the size and the number of bubbles generated by the instrument under positive pressure and negative pressure conditions in the releasing process can be rapidly and accurately detected, so that quantitative instrument system bubble generation conditions are obtained, and possible air embolism risks caused by the instrument are further evaluated.
Specifically, referring to fig. 1, the in-vitro simulation unit 10 includes a heart simulation device 11, a simulated blood vessel 12, check valves (13a, 13b), a monitoring subunit 14, and a constant temperature subunit 15.
The heart simulator 11 comprises a simulated heart pulse pump. Illustratively, the simulated cardiac pulsation pump includes a voice coil motor or servo motor that operates to produce a pulsating motion that provides a power source for the entire test system. Illustratively, as shown in fig. 1, the simulated heart pulsation pump further comprises a hydraulic cylinder, the hydraulic pressure comprises a cylinder body and a piston, the motor drives the piston to move, and the volume of the cylinder body is changed during the movement of the piston, so that positive pressure and negative pressure are formed.
The simulated blood vessel 12 is in circuit communication with the heart simulator 11. The simulated blood vessel 12 has an inflow end and an outflow end, and both the inflow end and the outflow end of the simulated blood vessel 12 are connected with the heart simulator 11, so as to realize loop communication with the heart simulator 11. Preferably, the simulated blood vessel 12 is over-designed with a circular arc at the corners to create a steady-state flow of liquid, effectively reducing the generation of turbulent bubbles.
In order to further simulate the diseased blood vessel environment, a diseased simulated test part 12a is locally arranged on the whole section of the simulated blood vessel 12, in the process of puncture test, an instrument sample A to be tested is punctured into the simulated test part 12a and then releases an implant in the sample, and in the release process of the implant, air bubbles are generated in the diseased simulated test part 12 a. Illustratively, the diseased simulated test portion 12a is an expanded simulated hemangioma.
In other embodiments, in order to clearly observe the releasing process and the generation process of the bubbles, the simulation test portion 12a is made of a transparent material to form a transparent simulation test portion 12a, and the tester can visually observe the internal environment and the generation and change process of the bubbles during the test process through the arrangement of the transparent simulation test portion 12 a. In some embodiments, the entire simulated vessel 12 may be formed of a transparent material for ease of fabrication.
The check valves (13a, 13b) include an inflow check valve 13a and an outflow check valve 13 b. The inflow check valve 13a is provided at the inflow end of the dummy blood vessel 12 for controlling the inflow of the liquid only in one direction. The outflow check valve 13b is arranged at the outflow end of the simulated blood vessel 12 and is used for controlling the liquid to flow out only in one direction.
In some embodiments, in order to realize automatic control, a check valve that only allows one-way flow of liquid is connected to the controller 31, as shown in fig. 1, the inflow check valve 13a and the outflow check valve 13b are respectively connected to the controller 31, and the opening and closing of the inflow check valve 13a and the outflow check valve 13b are respectively controlled by the controller 31.
In other embodiments, the inflow check valve 13a and the outflow check valve 13b are not connected to the controller 31, and the inflow check valve 13a and the outflow check valve 13b are self-opened or self-closed directly by the pressure change of the fluid flow.
Illustratively, referring to fig. 1, 2 and 3 together, as a preferred embodiment in which the inflow check valve 13a and the outflow check valve 13b are self-opened or self-closed directly by the pressure change of the fluid flow, the check valves (13a, 13b) are both cusp valves having a valve-like structure, i.e., the inflow check valve 13a is configured as an inflow cusp valve having a valve-like structure, and the outflow check valve 13b is configured as an outflow cusp valve having a valve-like structure. The cusp valve with the similar valve structure enables the established in vitro environment to better meet the test requirements, and the valve structure can effectively reduce turbulence. It should be noted that the inflow check valve 13a and the outflow check valve 13b may be alternatively configured as cusp valves having valve-like structures, or may be configured as cusp valves having valve-like structures, and the specific selection manner is set according to needs. In addition, based on the above-described manner of control by the controller 31, it is also possible to connect one check valve configured as a cusp valve having a valve-like structure, which is selected as needed from the inflow check valve 13a and the outflow check valve 13b, and another check valve not having a cusp valve having a valve-like structure, to the controller 31, with the opening and closing being controlled by the controller 31. It should be understood that the above-described manner is illustrative only and not limiting.
Illustratively, a structure of a one-way valve having a valve-like structure may be as shown in fig. 2 and 3, the cusp valve including a support structure 131 and flexible leaflets 132, the support structure 131 defining apertures for blood flow, the flexible leaflets 132 connecting the support structure 131, wherein the leaflets are movable relative to the support structure 131 between an open state in which the leaflets allow blood flow through the apertures in the support structure 131 and a closed state in which the leaflets restrict blood flow through the apertures in the support structure 131. It should be noted that this structure is only an exemplary illustration of a cusp valve, and is not limited thereto.
The monitoring subunit 14 is arranged on the circulation path of the simulated blood vessel 12, and the monitoring subunit 14 is connected with the controller 31; the monitoring subunit 14 is configured to monitor circulation information on the simulated blood vessel 12 and transmit the circulation information to the controller 31, and the controller 31 is further configured to control the pulse period of the heart simulator 11 according to the circulation information.
Illustratively, the monitoring subunit 14 includes a pressure sensor 14a disposed on the simulated blood vessel 12, the pressure sensor 14a being connected to the controller 31; the pressure sensor 14a is used for collecting pressure information on the simulated blood vessel 12 and transmitting the pressure information to the controller 31, and the controller 31 is used for adjusting the pulse period of the heart simulator 11 according to the pressure information.
Illustratively, the monitoring subunit 14 includes a flow sensor 14b disposed on the simulated blood vessel 12, the flow sensor 14b being connected to the controller 31; the flow sensor 14b is used to collect flow information flowing through the simulated vessel 12 and transmit the flow information to the controller 31, and the controller 31 is used to adjust the pulse period of the heart simulator 11 according to the flow information.
Wherein, the monitoring and controlling process is as follows: a certain monitoring parameter or monitoring parameter range is preset in the controller 31, for example, a certain pressure value and flow value, or a certain pressure range and flow range, after the monitoring subunit 14 transmits the monitored pressure information and flow information on the simulated blood vessel 12 to the controller 31, the controller 31 compares the received pressure information and flow information with the preset monitoring parameter or monitoring parameter range, and if the difference between the received pressure information and flow information and the monitored parameter is not equal to or exceeds an expected value, or is not within the parameter range, the heart simulator 11 is controlled to adjust the pulsation cycle and adjust the output volume of the fluid, so that the flow and pressure of the fluid meet the requirements.
It should be noted that the pressure sensor 14a and the flow sensor 14b in the monitoring subunit 14 may be alternatively arranged, and of course, may also be arranged at the same time in order to improve the monitoring accuracy. In addition, besides the pressure sensor 14a and the flow sensor 14b, other monitoring devices may be provided according to the needs, and the connection and control process thereof can be referred to the pressure sensor 14a and the flow sensor 14b, but is not limited thereto.
Because the monitoring subunit 14 monitors the local circulation information of the simulated blood vessel 12, in order to further ensure that the simulated environment during the local puncture release process better meets the simulation requirement, in other embodiments, the monitoring subunit 14 is disposed near the upstream of the simulated testing portion 12a, which ensures that the circulation information near the simulated testing portion 12a meets the simulation data requirement before testing as much as possible, so that the testing result is more real.
The thermostat unit 15 is disposed on the flow path of the simulated blood vessel 12, and the thermostat unit 15 is used for keeping the temperature of the liquid in the simulated blood vessel 12 within a certain temperature range. Preferably, the temperature range is 37. + -. 2 ℃ that is, the range is 35 ℃ or more and 39 ℃ or less. It should be noted that the setting of this temperature range is based on the testing requirement, and the temperature range of 37 ± 2 ℃ in this embodiment is only an exemplary illustration based on the simulated human body temperature, and is not limited thereto, and the range kept in the testing requirement is within the protection scope of this application. For example, in order to be closer to the human environment, the temperature range may be required to be 36 ℃ to 37.6 ℃, and the constant temperature subunit 15 ensures the stability of the temperature in the test process and effectively ensures the test accuracy.
Illustratively, the thermostatic subunit 15 comprises a confluence cavity 15a communicated with the simulated blood vessel 12, and a temperature sensor 15b and a heating device 15c arranged in the confluence cavity 15a, wherein the temperature sensor 15b and the heating device 15c are both connected with the controller 31; the temperature sensor 15b is used for monitoring the temperature of the liquid and transmitting the temperature information to the controller 31, and the controller 31 is used for controlling the heating device 15c to be turned on and off according to the temperature information.
Illustratively, the constant temperature can be realized by means of a water bath, for example, the constant temperature subunit 15 includes a box, and a temperature sensor 15b and a heating device 15c arranged in the box, and the box is filled with liquid. The simulated blood vessel 12 can pass through the box body, so that a section of the simulated blood vessel 12 is placed in liquid in the box body, and the temperature sensor 15b and the heating device 15c are both connected with the controller 31; the temperature sensor 15b is used for monitoring the temperature of the liquid in the box body and transmitting the temperature information to the controller 31, and the controller 31 is used for controlling the heating device 15c to be turned on and off according to the temperature information, so that the temperature of the liquid in the simulated blood vessel 12 can be kept within a certain temperature range, and the stability of the simulated environment is further ensured.
When the thermostating is achieved by means of a water bath, the heart simulator 11 and the thermostat subunit 15 can be placed in one housing S, as shown in fig. 1.
Similarly, since the constant temperature subunit 15 monitors the local temperature of the simulated blood vessel 12, in order to further ensure that the simulated environment during the local puncture release process meets the simulation requirement, in other embodiments, the constant temperature subunit 15 is disposed near the upstream of the simulated test portion 12a, and this arrangement ensures that the temperature of the liquid near the simulated test portion 12a is within the required temperature range as much as possible before the test, so that the test result is more realistic.
In some embodiments, in order to further improve the accuracy of monitoring the temperature, a plurality of temperature sensors 15b may be disposed at intervals along the circulation path of the simulated blood vessel 12, the plurality of temperature sensors 15b monitor simultaneously and transmit temperature information to the controller 31, and the controller 31 processes the plurality of temperature information simultaneously, so as to make a judgment on whether to start heating and on the heating temperature, which avoids the inaccuracy caused by local monitoring and effectively ensures the stability and precision of monitoring.
It should be noted that the specific configuration of the thermostat subunit 15 is only an exemplary one, and is not limited thereto, and any implementation of the thermostat control process is within the scope of the present application.
Specifically, as shown in fig. 1, the detection unit 20 includes a bubble detector 20, and the diameter and number distribution of bubbles can be detected by the bubble detector 20. Illustratively, the bubble detector 20 comprises an ultrasonic bubble counter, as shown in FIG. 1, which employs pulsed ultrasonic detection techniques, wherein ultrasonic energy is transmitted from an ultrasonic transmitter 21, the signal is attenuated by passing through a bubble in the medium, and the resulting signal is picked up by an ultrasonic receiver probe 22, thus achieving non-contact detection, and providing reliable, non-invasive, non-destructive, and non-destructive detection of bubbles for patients and other equipment. Compared with the visual observation, the high-precision ultrasonic bubble detector can more efficiently and accurately detect the diameter and the quantity of bubbles generated by the implant mechanical system in the simulated use process, and can output the distribution relation between the diameter and the quantity of the bubbles by connecting with the control unit; the relationship between the amount of bubbles generated during release and the release time can also be analyzed to assess at which site of the implant the most amount of bubbles are generated when released. Therefore, the space structure of the implant instrument product can be effectively optimized by research personnel, and residual air bubbles in the implant instrument system can be reduced through an effective air exhaust design. Preferably, the bubble detector 20 is disposed around the simulation test part 12a so that generated bubbles can be effectively covered in time to ensure the detection effect.
Specifically, the control unit 30 includes a controller 31 and a control panel 32. The controller 31 is connected to the heart simulator 11 for controlling the pulse cycle of the heart simulator 11. The controller 31 is also connected to the monitoring subunit 14 and the thermostat subunit 15 for acquiring monitoring information and temperature information to control the pulse cycle of the heart simulator 11.
The control panel 32 is connected to the controller 31, and the control panel 32 is used for visually displaying information. In addition, the operator can input a control signal through the control panel 32 to perform human-computer interaction.
In other embodiments, the bubble detector 20 is connected to the controller 31, the bubble detector 20 is configured to send bubble detection information to the controller 31, and the control panel 32 is configured to visually display the bubble detection information received by the controller 31. Illustratively, the visual display can directly display the number and the size of the detected bubbles, and can also be displayed in a chart mode, and the visual display can be set according to specific needs.
The device testing system uses the voice coil motor or the servo motor pump system as a power source for simulating the heart pulsation pump, the fluid pipeline is matched with the one-way valve function of the simulated valve structure, the periodic contraction and relaxation of the heart can be simulated, and the pressure and flow monitoring is configured at the same time, so that the pulsating blood pressure in the blood vessel can be simulated more truly and accurately, and the device simulated release testing process is closer to the in-vivo clinical effect; in addition, the air bubble is more favorably separated from the implant instrument system under the negative pressure condition, and for instrument research personnel, residual air in the instrument can be more comprehensively evaluated by the aid of the test system. The simulated blood pressure range of the test system can cover a range from-200 mmHg to 200mmHg, the pressure monitoring range in the test process is wider, and the application range of the detection method is wider.
Referring to fig. 1, the operation of the exemplary instrument testing system of the present invention is:
the liquid with a certain volume is periodically output through the reciprocating motion of a voice coil motor or a servo motor pump of a simulated heart pulsation pump power source and flows in the simulated blood vessel 12. When the piston 11a is pushed forwards, the inflow check valve 13a is opened, the outflow check valve 13b is closed, and liquid flows in the pipeline at a certain pressure and flow rate through the inflow check valve 13a to generate anticlockwise motion; when the piston 11a returns to its motion, the inflow check valve 13a closes, the return outflow check valve 13b opens, and fluid continues to flow back into the motor chamber in a counterclockwise direction. The motor reciprocates to drive the liquid in the simulated cardiovascular vessel to move at a certain flow rate and pressure, so that the liquid movement in the cardiovascular vessel in a pulsation period is simulated.
Under the environment condition of the simulated pulsation cycle, the simulated human body average blood pressure and blood flow velocity, the fluid temperature and the motion frequency of the simulated heart pulsation pump are preset on the control unit 30. When the test system is operated, the control unit 30 adjusts the output of the simulated cardiac pulsation pump according to the preset fluid parameters, so that the test system stably operates under the set parameter conditions (pressure and flow rate).
And (3) penetrating a sample puncture sealing gasket of the implant instrument system to a position simulating hemangioma lesion, simulating to release the sample, detecting bubbles generated in the process by using an ultrasonic bubble detector, and outputting the diameter and the quantity of the generated bubbles. Wherein, different parameters can be set by adjustment, different pressure and flow parameters can be simulated respectively, and the bubble generation result of the sample of the implant instrument system can be detected.
The process of testing using the exemplary instrument testing system of the present invention is:
firstly, filling oxygen-removing water into a test system, comprising a heart pulsation simulation pump, operating the test system, starting a heating device 15c in the constant temperature subunit 15 to heat and keep the water temperature at 37 +/-2 ℃, and removing bubbles generated in the system.
The pressure sensor 14a and the flow sensor 14b in the monitoring subunit 14 collect pressure information and flow information and transmit the pressure information and the flow information to the control unit 30, the control unit 30 further controls the output of the heart pulsation simulation pump according to the received pressure information and flow information, and the effect of controlling the pressure and the flow is achieved by adjusting the stroke and the frequency of the motor.
Taking out an instrument sample A to be tested, and performing air exhaust operation by using deoxidized water according to an instrument use instruction; after wetting the sample surface, the puncture seal a1 was simulated in the simulated test portion 12 a. Wherein, sealed pad A1 adopts the slot hole silica gel pad of certain length to carry out radial locking sealed, guarantees that the sheath pipe reaches totally sealed nothing to leak at the propelling movement release in-process, can not introduce the bubble, prevents to reveal and bubble production.
The implant instrument system delivery sheath slowly releases under the regulated specified pressure condition (positive pressure or negative pressure) according to the operation requirements of the product use instruction, the quantity and the size of bubbles generated in the simulated release process are detected by an ultrasonic bubble counter, and the bubble information data are transmitted to the control unit 30 for visual display.
The instrument testing system provided by the utility model establishes a simulation environment in vitro, performs simulated release in the simulation environment, and performs automatic detection through the bubble detector in the release process, so that the diameter and the quantity of bubbles generated by the implant instrument system in the simulated use process are efficiently and accurately detected, the whole process is simple and convenient, the precision is high, the test result is closer to clinical conditions, and the risk assessment is more sufficient.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the appended claims.
Claims (10)
1. Apparatus test system, its characterized in that, including external analog unit, detecting element and the control unit, wherein:
the in-vitro simulation unit comprises a heart simulation device, a simulation blood vessel communicated with a loop of the heart simulation device, and an inflow check valve and an outflow check valve which are respectively arranged on an inflow end and an outflow end of the simulation blood vessel, wherein the simulation blood vessel comprises a simulation test part;
the detection unit includes a bubble detector for detecting bubbles in the simulation test part;
the control unit comprises a controller, the heart simulator is connected with the controller, and the controller is used for controlling the pulse cycle of the heart simulator.
2. The instrumented testing system of claim 1, wherein the inflow and/or outflow check valves are configured as inflow and/or outflow cusp valves having a valve-like structure.
3. The device testing system of claim 1 or 2, wherein the extracorporeal simulation unit further comprises a monitoring subunit disposed on the simulated vascular flow path, the monitoring subunit being connected to the controller; the monitoring subunit is used for monitoring circulation information on the simulated blood vessel and transmitting the circulation information to the controller, and the controller is also used for controlling the pulse cycle of the heart simulation device according to the circulation information.
4. The device testing system of claim 3, wherein the monitoring subunit includes a pressure sensor disposed on the simulated blood vessel, the pressure sensor being coupled to the controller; the pressure sensor is used for collecting pressure information on the simulated blood vessel and transmitting the pressure information to the controller, and the controller is used for adjusting the pulse cycle of the heart simulation device according to the pressure information; and/or the presence of a gas in the gas,
the monitoring subunit comprises a flow sensor arranged on the simulated blood vessel, and the flow sensor is connected with the controller; the flow sensor is used for collecting flow information flowing through the simulated blood vessel and transmitting the flow information to the controller, and the controller is used for adjusting the pulse period of the heart simulation device according to the flow information.
5. The instrument testing system of claim 3 wherein said monitoring subunit is disposed adjacent and upstream of said simulated test portion.
6. The device testing system of claim 1 or 2, wherein the extracorporeal simulation unit further comprises a thermostat subunit disposed on the simulated blood vessel flow path, the thermostat subunit being configured to maintain a temperature of the fluid within the simulated blood vessel within a temperature range.
7. The device testing system of claim 6, wherein the thermostatic subunit comprises a manifold chamber in communication with the simulated blood vessel, and a temperature sensor and a heating device disposed in the manifold chamber, the temperature sensor and the heating device both being connected to the controller; the temperature sensor is used for collecting the temperature of the liquid and transmitting the temperature information to the controller, and the controller is used for controlling the heating device to be opened or closed according to the temperature information.
8. The instrument testing system of claim 6, wherein the temperature range is 37 ± 2 ℃.
9. The instrument testing system of claim 1, wherein the control unit further comprises a control panel connected to the controller;
the bubble detector is connected with the controller, the bubble detector is used for sending bubble detection information to the controller, and the control panel is used for visually displaying the bubble detection information received by the controller.
10. The instrumentation test system of claim 1, wherein said heart simulating means comprises a simulated cardiac pulsation pump and/or said bubble detector comprises an ultrasound bubble counter.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN115672431A (en) * | 2022-10-18 | 2023-02-03 | 哈尔滨工业大学（威海） | Extracorporeal circulation and intraluminal intervention isolated blood vessel constant temperature auxiliary device |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN115672431A (en) * | 2022-10-18 | 2023-02-03 | 哈尔滨工业大学（威海） | Extracorporeal circulation and intraluminal intervention isolated blood vessel constant temperature auxiliary device |
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