An in vitro cytotoxicity testing device for anesthesia breathing circuit and its working method

Abstract

The present invention discloses an in vitro cytotoxicity testing device for anesthesia breathing circuit and a working method thereof, which belongs to the field of medical device inspection technology. The testing device includes a gas power control device, an in vitro artificial lung breathing system and a gas condensate collection device. The gas power control device includes a cylinder simulating breathing movement, the in vitro artificial lung breathing system includes a gas storage container, an air bag is arranged inside the gas storage container, an airtight water sealing device is arranged below the gas storage container, and the in vitro artificial lung breathing system is located in an insulated box; the gas condensate collection device includes a condenser tube and a condensate collection bottle. The technical solution of the example of the present invention truly simulates the actual clinical use situation to test the cytotoxicity index of the gas pipeline, and the collected gas condensate can be used for other biocompatibility testing needs, fundamentally solving the problem of biocompatibility testing of medical devices such as gas pipelines for anesthesia breathing.

Description

Technical Field

[0001] The present invention relates to the technical field of medical device inspection and detection, and in particular to an in vitro cytotoxicity test of an anesthetic breathing tube, specifically an in vitro cytotoxicity test device for an anesthetic breathing tube and a working method thereof. Background Art

[0002] Anesthesia breathing circuits are medical gas products used in conjunction with anesthesia machines, ventilators, dehumidifiers, and nebulizers. Their purpose is to connect endotracheal tubes and breathing masks to the above machines to form a set of anesthesia breathing equipment. Anesthesia breathing circuits are large-volume and widely used medical consumables and are medical devices directly related to the patient's life. Anesthesia breathing equipment is a Class III high-risk medical device that requires strict control of its potential biological risks. Unlike conventional medical device products, anesthesia breathing circuits are in contact with the human respiratory tract and alveoli through gas. Therefore, the cytotoxicity test using the conventional extraction method cannot truly reflect the biocompatibility of the product, and it is necessary to design corresponding professional equipment for precise testing.

[0003] Cytotoxicity testing is a test item that must be conducted for all medical devices that come into contact with the human body. At present, the cytotoxicity test of respiratory anesthesia circuits in the industry is to first cut the sample to be tested into pieces, and then prepare the test solution according to the mass-to-volume ratio or surface-to-volume ratio for testing. Although this method can detect the cytotoxic components in the extractables in the device materials, it is not possible to perform product cytotoxicity detection and evaluation under conditions that simulate the actual clinical use of respiratory circuits. The test results often cannot truly reflect the actual toxic effects of the product. On the one hand, false positive results are prone to occur, and on the other hand, volatile toxic substances are easily missed. Therefore, if a cytotoxicity testing device that can simulate the actual clinical use status can be designed, and the quality inspection and evaluation of anesthesia respiratory circuit products can be carried out first in the industry, it will fill the gap in key testing technologies in this field and have great practical application value and significance.

[0004] Based on the above practical needs, designing a test device for the cytotoxicity of anesthesia breathing circuits is an issue that needs to be urgently addressed. Summary of the invention

[0005] In order to address the deficiencies in the above-mentioned prior art, the purpose of the present invention is to provide an in vitro cytotoxicity testing device for anesthesia breathing circuits and a working method thereof. The testing device and the working method thereof can truly simulate actual clinical usage to test the cytotoxicity index of the gas pipeline, and the collected gas condensate can be used for other biocompatibility testing needs, thereby fundamentally solving the problem of biocompatibility testing of medical devices such as gas pipelines for anesthesia breathing.

[0006] The technical solution adopted by the present invention to solve the technical problem includes:

[0007] In one aspect, the present invention provides an in vitro cytotoxicity testing device for anesthesia breathing circuits, comprising:

[0008] a gas power control device, the gas power control device including a cylinder that simulates the breathing movement;

[0009] An extracorporeal artificial lung breathing system, the extracorporeal artificial lung breathing system comprises an air storage container, an air bag is arranged inside the air storage container, an airtight water seal device is arranged below the air storage container, an exhalation pipeline and an inhalation pipeline are arranged inside the airtight water seal device; the air storage container is connected with the air flow inlet and outlet of the gas power control device through a gas power pipeline; one end of the exhalation pipeline is connected to the air bag, and the other end of the exhalation pipeline is passed into the water of the airtight water seal device; one end of the inhalation pipeline is used to connect a test sample to be tested, and the other end of the inhalation pipeline is passed into the water of the airtight water seal device; the part above the water surface of the airtight water seal device is also respectively provided with an exhalation outlet and an inhalation outlet, the exhalation outlet is connected to the test sample to be tested, and the inhalation outlet is connected to the air bag; the extracorporeal artificial lung breathing system is located in an insulated box;

[0010] A gas condensate collection device, the gas condensate collection device comprises a condenser and a condensate collection bottle, one end of the condenser is connected to an end of the test sample to be tested away from the extracorporeal artificial lung breathing system, and the other end of the condenser is connected to the condensate collection bottle; the condensate collection bottle is also connected to a heat and moisture exchanger connecting pipe.

[0011] Furthermore, the cylinder in the gas power control device includes a control cylinder and an actuator cylinder, the moving part of the control cylinder is connected to the piston rod of the actuator cylinder, and the control cylinder is controlled by a solenoid valve to perform reciprocating motion.

[0012] Furthermore, the airtight water seal device includes a water storage container, which forms a sealing connection with a cover plate at its opening, and a longitudinal partition is provided inside the water storage container; the side edge of the partition is fixedly connected to the inner wall of the water storage container, the upper edge of the partition is tightly fitted with the cover plate, and the lower edge of the partition extends below the water surface of the water storage container; an exhalation hole and an inhalation hole are provided on the partition, and the exhalation hole and the inhalation hole are both located below the water surface, the exhalation pipe is connected to the exhalation hole, and the inhalation pipe is connected to the inhalation hole.

[0013] Furthermore, valve chambers are respectively provided on both sides of the partition at the top of the water storage container, the connection between the exhalation line and the airbag and the inhalation outlet are located in one valve chamber, and the connection between the inhalation line and the test sample to be tested and the exhalation outlet are located in another valve chamber; a first one-way valve is provided at the connection between the exhalation line and the airbag to limit the flow of gas from the airbag to the exhalation line, a second one-way valve is provided at the inhalation outlet to limit the flow of gas from the water storage container to the airbag, a third one-way valve is provided at the connection between the inhalation line and the test sample to be tested to limit the flow of gas from the test sample to the inhalation line, and a fourth one-way valve is provided at the exhalation outlet to limit the flow of gas from the water storage container to the test sample to be tested.

[0014] Furthermore, a heating element and a first temperature sensor for measuring water temperature are provided inside the water storage container, the heating element extends below the water surface, and a regulator of the heating element is connected to the first temperature sensor.

[0015] Furthermore, a heat light source lighting element and a second temperature sensor for detecting the air temperature in the box are provided in the heat-insulating box, and a regulator of the heat light source lighting element is connected to the second temperature sensor.

[0016] Furthermore, the condenser is a serpentine condenser, and / or the condensate collecting bottle is a round-bottom flask.

[0017] Furthermore, an air filter is provided at the opening of the condensate collecting bottle.

[0018] Furthermore, the condenser is equipped with a cooling distilled water circulation container and a circulation pump, and the circulation container, the circulation pump and the outer tube of the condenser constitute a circulation pipeline for the cooling distilled water.

[0019] On the other hand, the present invention also provides a working method of the above-mentioned in vitro cytotoxicity testing device for anesthesia breathing circuit, comprising:

[0020] Add liquid to the airtight water seal device to a suitable liquid level to ensure the airtightness of the extracorporeal artificial lung breathing system, and connect the gas power control device and the extracorporeal artificial lung breathing system;

[0021] The liquid in the airtight water seal device and the air in the extracorporeal artificial lung breathing system reach the set temperature;

[0022] Simulate the breathing rate of the frequency-setting gas-powered control device used clinically;

[0023] Connect one end of the test sample to the extracorporeal artificial lung breathing system and the other end to the condenser tube;

[0024] The gas power control device is operated to input gas into the extracorporeal artificial lung breathing system in a manner simulating the frequency of clinical use. The gas is heated and humidified by the extracorporeal artificial lung breathing system. After the warm and humidified gas is condensed into liquid by the condenser tube, the condensate is collected in a condensate collection bottle.

[0025] After the in vitro cytotoxicity test device for anesthesia breathing circuit has been running for 72 h±2 h, the test is terminated;

[0026] The gas condensate in the condensate collection bottle was collected, mixed with 10% serum-containing cell culture medium at a ratio of 1:1, and a cytotoxicity test was performed to obtain the test results.

[0027] Compared with the prior art, the present invention has the following beneficial effects:

[0028] 1. The in vitro cytotoxicity test device for anesthesia breathing circuit of the present invention uses a gas power control device to generate gas source conditions (oxygen and air mixed in proportion) that are the same as the gas source and parameters when the patient uses an anesthesia breathing circuit clinically. It can truly simulate the clinical use of anesthesia breathing circuits, and the data obtained from the test are more referenceable and effective.

[0029] 2. The in vitro cytotoxicity testing device for anesthesia breathing circuits exemplified in the present invention uses an in vitro artificial lung breathing system for the first time to simulate clinical use for testing, and uses a gas condensate collection device to collect volatile toxic substances (VOCs) in the anesthesia breathing system to be tested for cytotoxicity testing, so as to more scientifically and accurately evaluate the biocompatibility of anesthesia breathing circuit products.

[0030] 3. In the in vitro cytotoxicity testing device for anesthesia breathing circuit of the present invention, the gas power control device adopts a dual cylinder structure of a control cylinder and an actuator cylinder. The control cylinder is controlled by an electromagnetic valve to generate power to drive the actuator cylinder to generate gas. The control cylinder is equivalent to the active cylinder, and the actuator cylinder is equivalent to the driven cylinder. The principle is similar to the driving wheel and driven wheel on a car, which is convenient for controlling the frequency of the gas source.

[0031] 4. In the in vitro cytotoxicity test device for anesthesia breathing circuit of the present invention, the in vitro artificial lung breathing system is arranged in an insulating box, and a heating element, a heat light source lighting element, a first temperature sensor, a second temperature sensor and other temperature adjustment devices are arranged inside the insulating box to make the temperature of the liquid in the test circuit reach the target temperature, such as (37±1)°C, so that the test liquid is closer to the human body temperature and maintains this temperature during the test, thereby improving the accuracy of the test results.

[0032] 5. In the in vitro cytotoxicity test device for anesthesia breathing circuit of the present invention, a partition is provided in the water storage container, and a one-way valve is provided at the air flow inlet and outlet of each pipeline to reliably control the flow direction of the air flow and prevent the air flow from diffusing to other parts and affecting the test effect.

[0033] 6. In the in vitro cytotoxicity testing device for anesthesia breathing circuits of the present invention, a condenser adopts a serpentine condenser with a spiral inner core tube, which increases the length of the glass tube, increases the cooling area, and retains more condensate, making it suitable for gas condensation recovery; a condensate collection bottle adopts a round-bottom flask with a thinner mouth to prevent liquid from flowing out, and the inner wall of the round-bottom flask is a smooth curve to reduce the residual condensate inside.

[0034] 7. In the in vitro cytotoxicity test device for anesthesia breathing circuit of the present invention, an air filter is provided at the opening of the condensate collection bottle to ensure the sterility of the gas condensate collected in the condensate collection bottle and the accuracy of the test results.

[0035] 8. The in vitro cytotoxicity test device for anesthesia breathing circuit of the present invention is provided with a circulating container and a circulating pump for cooling distilled water. During use, ice packs are regularly added to the cooling distilled water. The cooling distilled water can be reused, which saves resources and improves the condensation effect.

[0036] 9. The working method of the in vitro cytotoxicity testing device for anesthesia breathing circuit of the example of the present invention keeps the frequency of gas passing through the anesthesia breathing circuit to be tested similar to that in actual clinical use, simulates the actual breathing conditions of clinical patients for testing, and can collect condensate containing volatile substances in the anesthesia circuit to be tested and use it for experimental analysis, thereby achieving comprehensive and accurate testing of the cytotoxicity of the anesthesia breathing circuit. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Other features, objects and advantages of the present application will become more apparent by reading the detailed description of non-limiting embodiments made with reference to the following drawings:

[0038] Figure 1 It is a schematic diagram of the overall structure of an embodiment of the present invention;

[0039] Figure 2 This is a front view of the airtight water sealing device according to an embodiment of the present invention;

[0040] Figure 3 for Figure 2 Left view of

[0041] Figure 4 This is a schematic diagram of the structure of a partition in an airtight water seal device according to an embodiment of the present invention;

[0042] Figure 5It is a schematic structural diagram of a cover plate in an airtight water sealing device according to an embodiment of the present invention.

[0043] In the figure: 1-gas storage container joint, 2-heat and moisture exchanger connecting pipe, 3-first temperature sensor, 4-condenser, 5-insulated box, 6-heating element, 7-second temperature sensor, 8-heat light source lighting element, 9-pipeline joint, 10-gas power pipeline, 11-Duck valve, 12-gas storage container, 13-air bag, 14-cover plate, 15-valve chamber, 16-partition plate, 17-water storage container, 18-pipeline, 181-expiratory pipeline, 182-inspiratory pipeline, 19-sealing ring, 20-air flow inlet and outlet, 21-air outlet, 22-dry air inlet, 23-condensate collection bottle, 24-test sample to be tested, 25-circulation container and circulation pump, 26-expiratory through hole, 27-inspiratory through hole, 28-air bag hole, 29-tracheal jack, 30-heating element jack, 31 first temperature sensor jack;

[0044] A-gas power control device, B-extracorporeal artificial lung breathing system, C-gas condensate collection equipment. DETAILED DESCRIPTION

[0045] The technical solution of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all of the embodiments.

[0046] The components of the embodiments of the present invention generally described and shown in the drawings herein may be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the present invention.

[0047] Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative work shall fall within the scope of protection of the present invention.

[0048] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0049] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0050] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. It should also be noted that, for ease of description, only the parts related to the invention are shown in the drawings.

[0051] like Figure 1 As shown, on the one hand, an embodiment of the present invention provides an in vitro cytotoxicity testing device for an anesthesia breathing circuit, comprising:

[0052] A gas power control device A, the gas power control device A includes a cylinder simulating a breathing movement;

[0053] The extracorporeal artificial lung breathing system B comprises an air storage container 12, an air bag 13 is arranged inside the air storage container 12, an airtight water seal device is arranged below the air storage container 12, and two pipelines 18 are arranged inside the airtight water seal device. Specifically, the pipeline 18 comprises an exhalation pipeline 181 and an inhalation pipeline 182; the air storage container 12 is connected to the air flow inlet and outlet 20 of the gas power control device A through the gas power pipeline 10; one end of the exhalation pipeline 181 is connected to the The airbag 13, the other end of the exhalation pipeline 181 is connected to the water of the airtight water seal device; one end of the inhalation pipeline 182 is used to connect the test sample 24 to be tested, and the other end of the inhalation pipeline 182 is connected to the water of the airtight water seal device; the part above the water surface of the airtight water seal device is also provided with an exhalation outlet and an inhalation outlet, the exhalation outlet is connected to the test sample 24 to be tested, and the inhalation outlet is connected to the airbag 13; the components of the extracorporeal artificial lung breathing system B are located in the insulated box 5;

[0054] The gas condensate collection device C comprises a condenser 4 and a condensate collection bottle 23, one end of the condenser 4 is connected to one end of the test sample 24 away from the extracorporeal artificial lung breathing system B, and the other end of the condenser 4 is connected to the condensate collection bottle 23; the condensate collection bottle 23 is also connected to a heat and moisture exchanger connecting tube 2.

[0055] Specifically, the cylinder in the gas power control device A includes a control cylinder and an actuator cylinder, the moving part of the control cylinder is connected to the piston rod of the actuator cylinder, and the control cylinder is controlled by a solenoid valve to perform a reciprocating motion. Controlling the reciprocating motion of the cylinder by a solenoid valve belongs to the prior art content, and those skilled in the art can master it skillfully, and its specific wiring method is not repeated here.

[0056] like Figure 2 , Figure 3 As shown, the airtight water seal device includes a water storage container 17, and the water storage container 17 forms a sealing connection with the cover plate 14 at its opening. To ensure the sealing of the cover plate 14, a sealing ring 19 is provided at the matching position of the cover plate 14 and the water storage container 17. A longitudinal partition 16 is provided inside the water storage container 17, and the side edge of the partition 16 is fixedly connected to the inner side wall of the water storage container 17. The upper edge of the partition 16 is tightly fitted with the cover plate 14, and the lower edge of the partition 16 extends below the water surface of the water storage container 17. The partition 16 divides the part above the water surface in the water storage container 17 into two spaces.

[0057] like Figure 4 As shown, the partition 16 is provided with an exhalation hole 26 and an inhalation hole 27, both of which are located below the water surface, the exhalation pipe 181 is connected to the exhalation hole 26, and the inhalation pipe 182 is connected to the inhalation hole 27.

[0058] The top of the water storage container 17 is provided with valve chambers 15 on both sides corresponding to the partition 16, the connection between the exhalation line 181 and the airbag 13 and the inhalation outlet are located in one valve chamber, and the connection between the inhalation line 182 and the test sample 24 to be tested and the exhalation outlet are located in another valve chamber; the connection between the exhalation line 181 and the airbag 13 is provided with a first one-way valve for limiting the flow of gas from the airbag 13 to the exhalation line 181, the inhalation outlet is provided with a second one-way valve for limiting the flow of gas from the water storage container 17 to the airbag 13, the connection between the inhalation line 182 and the test sample 24 to be tested is provided with a third one-way valve for limiting the flow of gas from the test sample 24 to the inhalation line 182, and the exhalation outlet is provided with a fourth one-way valve for limiting the flow of gas from the water storage container 17 to the test sample 24. The one-way valve is provided to reliably control the flow direction of the airflow to prevent the airflow from diffusing to other parts and affecting the test effect.

[0059] In order to truly simulate the environment inside the human body, the test device of this embodiment is provided with a temperature control system. Specifically, a heating element 6 and a first temperature sensor 3 for measuring the water temperature are provided inside the water storage container 17. The heating element 6 extends below the water surface, and the regulator of the heating element 6 is connected to the first temperature sensor 3. A heat light source lighting element 8 and a second temperature sensor 7 for detecting the air temperature inside the box are provided inside the heat-insulating box 5, and the regulator of the heat light source lighting element 8 is connected to the second temperature sensor 7.

[0060] The heating element 6 can be an electric heating rod, and the heat light source lighting element 8 can be a heat light source bulb, which is installed in the heat-insulating box 5 through a lamp holder. The first temperature sensor 3 and the second temperature sensor 7 can be pt100 temperature sensors, and the temperature control can be PID regulated to ensure that the test liquid and the test environment meet the set requirements. Liquid temperature control: 37℃±0.5℃; air temperature control: 37℃±1℃.

[0061] The structure of the cover plate 14 is as follows Figure 5 As shown, the cover plate 14 is provided with an airbag hole 28, an air tube insertion hole 29, a heating element insertion hole 30 and a first temperature sensor insertion hole 31. The airbag hole 28 is for the pipeline connected to the airbag 13 to pass through, the air tube insertion hole 29 is for the pipeline connected to the test sample 24 to pass through, the heating element insertion hole 30 is for the heating element 6 to pass through, and the first temperature sensor insertion hole 31 is for the first temperature sensor 3 to pass through.

[0062] In this embodiment, the water storage container 17 is a beaker, the condenser 4 is a serpentine condenser, the serpentine condenser has a size of 300 / 24*2 standard port connected to the test sample connection assembly, and the condensate collection bottle 23 is a round bottom flask. An air filter is provided at the opening of the condensate collection bottle 23.

[0063] The condenser 4 is equipped with a cooling distilled water circulation container and a circulation pump 25. The circulation container, the circulation pump and the outer tube of the condenser 4 constitute a circulation pipeline for cooling distilled water. The cooling distilled water uses zero-degree distilled water. The circulation container and the circulation pump 25 are set. During use, ice bags are regularly added to the cooling distilled water. The cooling distilled water can be reused, which saves resources and improves the condensation effect.

[0064] The heat and moisture exchanger connecting tube 2 has an inner diameter of 8mm, an outer diameter of 11mm, and a length of (95±5)mm. Its dry air inlet 22 is connected to dry air supplied according to the clinical use ratio, (23±1)℃, and <1mgH2O per liter of air. The gas power control device A can be set to simulate the breathing frequency used in clinical practice, with an adjustable interval of 0 to 9.9S and an adjustment accuracy of 0.1S. The gas power control device A uses PLC plus touch screen control. The parameters can be set directly on the touch screen and can be adjusted manually. The control part can refer to the control system of the ventilator. The gas power pipeline 10 is used to connect the gas power control device A to the extracorporeal artificial lung breathing system B.

[0065] The position where the connecting pipe of the air bag 13 on the air bag 12 extends out is provided with the air bag joint 1 to achieve a leak-free connection. The air bag hole 28 on the cover plate 14 is provided with a Duck valve 11, which has low back pressure and good sealing performance.

[0066] On the other hand, this embodiment also provides a working method of the above-mentioned in vitro cytotoxicity testing device for anesthesia breathing circuit, including:

[0067] S1: Add liquid to the airtight water seal device to a suitable liquid level to ensure the airtightness of the extracorporeal artificial lung breathing system B, and connect the air flow inlet and outlet 20 of the gas power control device A and the gas storage container 12 of the extracorporeal artificial lung breathing system B through the gas power pipeline 10;

[0068] S2: The liquid in the airtight water seal device and the air in the extracorporeal artificial lung breathing system B are made to reach the set temperature through the temperature control related components; specifically, the liquid temperature is controlled at: 37℃±0.5℃; the air temperature is controlled at: 37℃±1℃;

[0069] S3: Simulate the clinical use of frequency setting gas power control device A breathing rate;

[0070] S4: Connect one end of the test sample 24 to the extracorporeal artificial lung breathing system B, and the other end to the condenser tube 4;

[0071] S5: The gas power control device A operates to input gas into the extracorporeal artificial lung breathing system B at a frequency similar to clinical use. The gas is heated and humidified by the extracorporeal artificial lung breathing system B. The warm and humidified gas is condensed into liquid by the condenser 4, and the condensate is collected in the condensate collection bottle 23;

[0072] S6: After the in vitro cytotoxicity test device for anesthesia breathing circuit has been running for 72 h±2 h, the test is terminated;

[0073] S7: Collect the gas condensate in the condensate collection bottle 23, mix it with 10% serum-containing cell culture medium in a ratio of 1:1, perform a cytotoxicity test, and obtain the test results.

[0074] Among them, in S5, the specific process of the gas power control device A running and the extracorporeal artificial lung breathing system B simulating human breathing is:

[0075] S5-1: In the gas power control device A, the piston rod of the execution cylinder moves forward to generate a positive pressure airflow, which enters the gas storage container 12. The air pressure in the gas storage container 12 increases, and the compression airbag 13 contracts to simulate the exhalation process of the human body, and the gas is pressed out. The gas pressed out by the airbag 13 enters the water in the water storage container 17 through the exhalation pipe 181, and the gas in the exhalation pipe 181 emerges from the exhalation through hole 26, and is heated and humidified by the water in the water storage container 17 to simulate the state of the gas exhaled by the human body. Since the density of the gas is small, it will rise to the water surface. After the gas rises to the water surface, the air pressure in the area will increase, so the gas will flow out from the exhalation outlet, flow through the test sample 24 to be tested, the condenser 4 and the condensate collection bottle 23, and finally be discharged through the air outlet 21 of the heat and moisture exchanger connecting pipe 2, simulating the exhalation process of the human body.

[0076] S5-2: In the gas power control device A, the piston rod of the execution cylinder moves in the reverse direction to generate a negative pressure airflow, which enters the gas storage container 12. The air pressure in the gas storage container 12 decreases, and the airbag 13 expands to simulate the human body's inhalation process. Under the action of air pressure, the dry air provided by the dry air source enters the heat and moisture exchanger connecting pipe 2 through the dry air inlet 22, and enters the air intake pipe 182 through the heat and moisture exchanger. Under the guidance of the air intake pipe 182, the dry air enters the water in the water storage container 17. The gas in the air intake pipe 182 emerges from the air intake hole 26, and is heated and humidified by the water in the water storage container 17 to simulate the state of the gas inhaled by the human body. Due to the small density of the gas, it will rise to the water surface. After the gas rises to the water surface, the air pressure in the area will rise, so the gas will flow out from the air intake outlet and enter the airbag 13, simulating the human body's inhalation process.

[0077] The steps S5 - 1 and S5 - 2 of the working process are repeated alternately until the test is completed. In S5 - 1 , the warm and humid gas simulating the exhaled gas is condensed into liquid through the condenser 4 , and the condensed liquid is collected in the condensed liquid collection bottle 23 .

[0078] Among them, in S7, the specific steps of conducting the cytotoxicity test are to conduct the cytotoxicity test according to the MTT method specified in Appendix C of the national standard GB / T16886.5-2017 "Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Test" and determine the test results.

[0079] The above description is only a preferred embodiment of the present application and an explanation of the technical principles used. Those skilled in the art should understand that the scope of the invention involved in the present application is not limited to the technical solution formed by a specific combination of the above technical features, but should also cover other technical solutions formed by any combination of the above technical features or their equivalent features without departing from the inventive concept. For example, the above features are replaced with (but not limited to) technical features with similar functions disclosed in the present application.

[0080] Except for the technical features described in the specification, the remaining technical features are known technologies to those skilled in the art. In order to highlight the innovative features of the present invention, the remaining technical features will not be described here in detail.

Claims

1. An in vitro cytotoxicity test device for anesthesia breathing circuit, characterized in that: include: a gas power control device, the gas power control device including a cylinder that simulates the breathing movement; An extracorporeal artificial lung breathing system, the extracorporeal artificial lung breathing system comprises an air storage container, an air bag is arranged inside the air storage container, an airtight water seal device is arranged below the air storage container, an exhalation pipeline and an inhalation pipeline are arranged inside the airtight water seal device; the air storage container is connected with the air flow inlet and outlet of the gas power control device through a gas power pipeline; one end of the exhalation pipeline is connected to the air bag, and the other end of the exhalation pipeline is passed into the water of the airtight water seal device; one end of the inhalation pipeline is used to connect a test sample to be tested, and the other end of the inhalation pipeline is passed into the water of the airtight water seal device; the part above the water surface of the airtight water seal device is also respectively provided with an exhalation outlet and an inhalation outlet, the exhalation outlet is connected to the test sample to be tested, and the inhalation outlet is connected to the air bag; the extracorporeal artificial lung breathing system is located in an insulated box; A gas condensate collection device, the gas condensate collection device comprising a condenser and a condensate collection bottle, one end of the condenser is connected to an end of the test sample to be tested away from the extracorporeal artificial lung breathing system, and the other end of the condenser is connected to the condensate collection bottle; the condensate collection bottle is also connected to a heat and moisture exchanger connecting pipe; The airtight water seal device comprises a water storage container, the water storage container is sealedly connected with a cover plate at its opening, a longitudinal partition is arranged inside the water storage container; the side edge of the partition is fixedly connected to the inner side wall of the water storage container, the upper edge of the partition is tightly fitted with the cover plate, and the lower edge of the partition extends below the water surface of the water storage container; an exhalation through hole and an inhalation through hole are arranged on the partition, both of which are located below the water surface, the exhalation through hole is connected to the exhalation through hole, and the inhalation through hole is connected to the inhalation through hole; Valve chambers are respectively provided on both sides of the top of the water storage container corresponding to the partition, the connection between the exhalation line and the airbag and the inhalation outlet are located in one valve chamber, and the connection between the inhalation line and the test sample to be tested and the exhalation outlet are located in another valve chamber; a first one-way valve is provided at the connection between the exhalation line and the airbag to limit the flow of gas from the airbag to the exhalation line, a second one-way valve is provided at the inhalation outlet to limit the flow of gas from the water storage container to the airbag, a third one-way valve is provided at the connection between the inhalation line and the test sample to be tested to limit the flow of gas from the test sample to be tested to the inhalation line, and a fourth one-way valve is provided at the exhalation outlet to limit the flow of gas from the water storage container to the test sample to be tested; A heating element and a first temperature sensor for measuring water temperature are arranged inside the water storage container. The heating element extends below the water surface, and a regulator of the heating element is connected to the first temperature sensor.

2. The in vitro cytotoxicity testing device for anesthesia breathing circuit according to claim 1, characterized in that: The cylinder in the gas power control device includes a control cylinder and an actuator cylinder. The moving part of the control cylinder is connected to the piston rod of the actuator cylinder. The control cylinder is controlled by a solenoid valve to perform reciprocating motion.

3. The in vitro cytotoxicity testing device for anesthesia breathing circuit according to claim 1, characterized in that: The heat-insulating box is provided with a heat light source lighting element and a second temperature sensor for detecting the air temperature in the box, and the regulator of the heat light source lighting element is connected to the second temperature sensor.

4. The in vitro cytotoxicity testing device for anesthesia breathing circuit according to claim 1, characterized in that: The condenser is a serpentine condenser, and / or the condensate collecting bottle is a round-bottom flask.

5. The in vitro cytotoxicity testing device for anesthesia breathing circuit according to claim 1 or 4, characterized in that: An air filter is arranged at the opening of the condensate collecting bottle.

6. The in vitro cytotoxicity testing device for anesthesia breathing circuit according to claim 5, characterized in that: The condenser is equipped with a cooling distilled water circulation container and a circulation pump, and the circulation container, the circulation pump and the outer tube of the condenser constitute a circulation pipeline for the cooling distilled water.

7. A method for operating the in vitro cytotoxicity testing device for anesthesia breathing circuit according to any one of claims 1 to 6, characterized in that: include: Add liquid to the airtight water seal device to a suitable liquid level to ensure the airtightness of the extracorporeal artificial lung breathing system, and connect the gas power control device and the extracorporeal artificial lung breathing system; The liquid in the airtight water seal device and the air in the extracorporeal artificial lung breathing system reach the set temperature; Simulate the breathing rate of the frequency-setting gas-powered control device used clinically; Connect one end of the test sample to the extracorporeal artificial lung breathing system and the other end to the condenser tube; The gas power control device is operated to input gas into the extracorporeal artificial lung breathing system in a manner simulating the frequency of clinical use. The gas is heated and humidified by the extracorporeal artificial lung breathing system. After the warm and humidified gas is condensed into liquid by the condenser tube, the condensate is collected in a condensate collection bottle. After the in vitro cytotoxicity test device for anesthesia breathing circuit has been running for 72 h±2 h, the test is terminated; The gas condensate in the condensate collection bottle was collected and mixed with 10% serum-containing cell culture medium in a ratio of 1:1 to perform a cytotoxicity test and obtain the test results.

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