Leakage and impact resistance detection device of duplex accessory system for peritoneal dialysis

Abstract

The utility model relates to the technical field of medical instrument detection, and particularly discloses a leakage and impact resistance detection device of a duplex accessory system for peritoneal dialysis, which is characterized in that the maximum negative pressure which can be borne by the duplex accessory system for peritoneal dialysis is simulated by utilizing the liquid level differential pressure of a communicating vessel; the impact resistance of the duplex accessory system for peritoneal dialysis is tested according to whether leakage occurs after free falling impact, calculation is assisted by reading of an air pump pressure gauge, and accurate evaluation of the impact resistance of the duplex accessory system for peritoneal dialysis in a falling scene bearing certain negative pressure is achieved. The device can realize automatic operation, can reduce personal errors, is simple and quick to operate, is favorable for realizing automatic recording of test data, shortens test time, saves human resources, improves credibility of the measurement data, and is convenient for tracing product quality.

Description

Technical Field

[0001] The utility model relates to the technical field of medical device detection, and more specifically, to a detection device for the leakage and impact resistance of a double - connection accessory system for peritoneal dialysis. Background Technique

[0002] The double - connection accessory system for peritoneal dialysis, as a core component in the peritoneal dialysis treatment process, has a delicate structure design and comprehensive functions. This system usually consists of a double - lumen tube, a connector, a drainage bag, and a series of sealing devices, aiming to achieve the precise injection of peritoneal dialysis fluid and the smooth discharge of waste fluid. Its overall role is to simplify the peritoneal dialysis operation process, improve dialysis efficiency, and ensure the safety and comfort of patients. In terms of technical requirements, the double - connection accessory system for peritoneal dialysis not only needs to have good sealing performance but also be able to withstand a certain negative or positive pressure to avoid damage and leakage, resulting in the loss of dialysis fluid, an increased risk of infection, and air mixing into the dialysis fluid.

[0003] During the actual use process, the double - connection accessory system for peritoneal dialysis faces complex and variable environmental factors. Whether patients perform peritoneal dialysis independently at home or receive professional care in a clinic, problems such as the system falling or squeezing the drainage bag due to careless operation or unexpected situations may occur. These external impacts may not only damage the system structure but also affect the normal functioning of its functions, and even endanger the safety of patients. Therefore, the double - connection accessory system for peritoneal dialysis products need to conduct impact resistance performance tests before being put on the market. However, the existing medical device sealing testers still have limitations when evaluating the performance of the double - connection accessory system for peritoneal dialysis. Most of these testers focus on detecting the compressive capacity of the system in a static state, ignoring the impact and vibration and other dynamic factors in scenarios such as falling on the compressive capacity.

[0004] The current detection standard YY / T 1760 - 2021 "Disposable Peritoneal Dialysis Drainage Devices" does not contain a detection method for impact resistance. The current detection standard YY 0489 - 2004 "Disposable Sterile Drainage Catheters and Auxiliary Instruments" records the requirements for impact resistance detection, but does not give specific experimental schemes and devices.

[0005] Therefore, it is particularly important to develop a testing device and a testing method that can comprehensively evaluate the impact resistance performance of the double - connection accessory system for peritoneal dialysis in a moving state. This new type of testing device should be able to simulate the dynamic conditions in a falling scenario and test whether the system leaks and cracks under these conditions. With the help of this device, the actual performance of the double - connection accessory system for peritoneal dialysis can be evaluated more accurately, filling the gaps in the industry detection standards, providing a scientific basis for the optimal design of products, and ensuring the safety and comfort of patients during use. Content of the Utility Model

[0006] The present utility model aims to overcome at least one of the above-mentioned deficiencies of the prior art, and provides a detection device for the leakage and impact resistance of a double - connection accessory system for peritoneal dialysis, which is used to accurately evaluate the impact resistance of the double - connection accessory system for peritoneal dialysis under a falling scenario with a certain negative pressure, facilitating the observation of the actual performance of the product and providing a scientific basis for the optimal design of the product.

[0007] The technical solution adopted by the present utility model is to provide a detection device for the leakage and impact resistance of a double - connection accessory system for peritoneal dialysis, including:

[0008] The double - connection accessory system for peritoneal dialysis;

[0009] An air pump for providing negative pressure;

[0010] A control device for setting the pressure and controlling the air pump;

[0011] A buffer container, which is a sealed container, filled with liquid inside and having an air cavity;

[0012] A pressure gauge for monitoring the air pressure inside the buffer container;

[0013] A support frame for respectively installing the buffer container and the double - connection accessory system for peritoneal dialysis, the installation position of the buffer container being higher than that of the double - connection accessory system for peritoneal dialysis; and a release device is also provided for releasing the double - connection accessory system for peritoneal dialysis;

[0014] A connecting hose, one end of which is connected to the double - connection accessory system for peritoneal dialysis and the other end is connected to the buffer container; and

[0015] An impact plane for receiving the double - connection accessory system for peritoneal dialysis.

[0016] This solution's detection device is used to test the impact resistance of a double - connection accessory system for peritoneal dialysis when it bears a certain negative pressure. The principle is as follows. Let the target negative pressure borne by the double - connection accessory system for peritoneal dialysis when it is impacted be P0. The detection device includes a buffer container and a double - connection accessory system for peritoneal dialysis. The two are connected by a connecting hose to form a communicating vessel. Their positions are at different heights, with a liquid level difference H1. There is a tendency for the liquid to flow from the higher - placed buffer container to the lower - placed double - connection accessory system for peritoneal dialysis, but the air pump provides a negative pressure P1 to keep the liquid relatively static, and the negative pressure P1 is large enough to make the double - connection accessory system for peritoneal dialysis bear the target negative pressure P0. When the double - connection accessory system for peritoneal dialysis is under negative pressure, it deforms, and its elastic force has a tendency to make the liquid flow into the double - connection accessory system for peritoneal dialysis, and the deformation elastic force is equal to the absolute value of the target negative pressure P0 it receives. Since the double - connection accessory system for peritoneal dialysis is a soft and airtight container, and there is no gas in the connecting hose and the double - connection accessory system for peritoneal dialysis, both of them are subject to 1 unit of atmospheric pressure (1 atm), and the atmospheric pressure has a tendency to make the liquid flow back to the buffer container. To sum up, when the liquid level of the communicating vessel is stable and motionless, the forces in both the inflow and the back - flow directions reach equilibrium, that is, the sum of the liquid - level difference pressure and the elastic tension (i.e., the absolute value of the target negative pressure P0 received by the double - connection accessory system for peritoneal dialysis) is equal to the sum of the absolute value of the air - pump negative pressure and 1 unit of atmospheric pressure. Let the liquid density be ρ and the acceleration due to gravity be g, then the absolute value of the air - pump negative pressure |P1| = ρgH1+|P0| - 1 atm.

[0017] When the double - connection accessory system for peritoneal dialysis is released and freely drops onto the impact plane, the double - connection accessory system for peritoneal dialysis is impacted while bearing the maximum negative pressure, and its components should maintain tightness and should not leak. After standing still for 60 - 120 s after landing, if there is liquid leakage, the air pressure in the buffer container will drop, and the dropped value is recorded as the vacuum - degree loss value △P. If the vacuum - degree loss value is greater than 1% - 2% of the pressure value after the first drop, the impact resistance is unqualified.

[0018] This solution uses the liquid - level difference pressure of the communicating vessel to simulate the maximum negative pressure that the double - connection accessory system for peritoneal dialysis can bear, and tests the impact resistance of the double - connection accessory system for peritoneal dialysis by whether there is leakage after free - fall impact. Assisted by the reading of the air - pump pressure gauge for calculation, the operation and calculation are simple, and it realizes the accurate evaluation of the impact resistance of the double - connection accessory system for peritoneal dialysis in the falling scenario with a certain negative pressure.

[0019] Furthermore, the installation height of the double - connection accessory system for peritoneal dialysis is 0.5 - 1 m. This height range is used to simulate the height at which the double - connection accessory system for peritoneal dialysis drops from a table or chair in the clinical use scenario.

[0020] Preferably, the installation height of the double - connection accessory system for peritoneal dialysis is 0.7 m.

[0021] Further, the height difference between the buffer container and the double - connection accessory system for peritoneal dialysis does not exceed 1.2 m. The above - mentioned height difference does not affect the height difference after free fall, so it can be adjusted as needed. The height difference not exceeding 1.2 m can prevent the detection device from being higher than the ceiling, facilitating the test.

[0022] Further, the overall length of the hose is 0.5 - 2.2 m; the hose has a redundant part that can be extended and straightened, with a length of 0.5 - 1 m. The length of the hose should be greater than the height difference between the buffer container and the double - connection accessory system for peritoneal dialysis, and there should still be redundancy after the double - connection accessory system for peritoneal dialysis lands.

[0023] Further, a height - measuring device and a height - adjusting device are provided on the support frame. This facilitates the automatic recording of test data.

[0024] Further, the negative pressure provided by the air pump ranges from 0 to - 90 kPa, and the negative - pressure adjustment accuracy reaches - 0.1 kPa.

[0025] Further, the detection device further includes an ambient - temperature detection device and a timer. According to the current detection standard, the test is carried out at 20 - 30 °C.

[0026] The usage method of the above - mentioned detection device includes the following steps:

[0027] S1. Inject liquid into the connecting hose and the double - connection accessory system for peritoneal dialysis and discharge the gas. Inject liquid into the buffer container and retain the gas. Connect one end of the connecting hose to the double - connection accessory system for peritoneal dialysis, and fix the other end below the liquid level of the buffer container; connect the top of the buffer container to the air pump and the pressure gauge.

[0028] S2. Place the double - connection accessory system for peritoneal dialysis on the impact plane. Install the buffer container above the impact plane through the support frame. The height difference between the liquid level of the buffer container and the impact plane is H1. Let the liquid density be ρ, the gravitational acceleration be g, and the target negative pressure borne by the bag during landing impact be P0. Set the negative pressure P1 of the air pump in the control device, |P1| = ρgH1+|P0| - 1 atm. Turn on the air pump, and turn off the air pump after the pressure - gauge reading stabilizes.

[0029] S3. Lift the double - connection accessory system for peritoneal dialysis and install it at a height H2 above the impact plane through the support frame, and H1 > H2. Remove the double - connection accessory system for peritoneal dialysis and let it freely fall from the height H2 to the impact plane at normal temperature, and no leakage should occur.

[0030] S4. Measure and record the pressure - gauge reading P2 after 60 - 120 s after the impact, and calculate the vacuum - degree loss value △P = P1 - P2. If △P is not greater than 1% - 2% of P1, the impact resistance is qualified.

[0031] Further, the range of the target negative pressure P0 is -50 kPa ≤ P0 ≤ -90 kPa.

[0032] Further, the range of the height H2 is 0.5 m ≤ H2 ≤ 1 m.

[0033] Compared with the prior art, the beneficial effects of the present utility model are as follows:

[0034] The detection device for leakage and impact resistance of the double - connection accessory system for peritoneal dialysis provided by this solution uses the pressure difference of the liquid levels in a communicating vessel to simulate the maximum negative pressure that the double - connection accessory system for peritoneal dialysis can withstand. By checking whether there is leakage after free - fall impact, the impact resistance of the double - connection accessory system for peritoneal dialysis is tested. With the assistance of the reading of the air - pump pressure gauge for calculation, the accurate evaluation of the impact resistance of the double - connection accessory system for peritoneal dialysis in a falling scenario with a certain negative pressure is achieved. This device can achieve automated operation, reduce human error, is simple and fast to operate, is conducive to automatically recording test data, shortening the test time, saving human resources, improving the credibility of measurement data, and facilitating product quality traceability. Description of the Drawings

[0035] Figure 1 It is a schematic structural diagram of Embodiment 1 of the present utility model.

[0036] Label description: double - connection accessory system 1 for peritoneal dialysis, air pump 2, buffer container 3, pressure gauge 4, support frame 5, height scale 6, connecting hose 7, impact plane 8. Detailed Embodiments

[0037] The drawings of the present utility model are only for illustrative purposes and should not be construed as a limitation to the present utility model. For better illustrating the following embodiments, some components in the drawings may be omitted, enlarged or reduced, which do not represent the dimensions of the actual product; for those skilled in the art, it is understandable that some well - known structures and their descriptions in the drawings may be omitted.

[0038] Embodiment 1

[0039] As Figure 1 shown, this embodiment provides a detection device for leakage and impact resistance of a double - connection accessory system for peritoneal dialysis, including:

[0040] Double - connection accessory system 1 for peritoneal dialysis;

[0041] Air pump 2, used to provide negative pressure;

[0042] Control device (not shown in the figure), used to set the pressure and control the air pump 2;

[0043] Buffer container 3, which is a sealed container, filled with liquid and having an air cavity inside;

[0044] A pressure gauge 4 for monitoring the air pressure in the buffer container 3;

[0045] A support frame 5 for respectively installing the buffer container 3 and the double - connection accessory system 1 for peritoneal dialysis. The installation position of the buffer container 3 is higher than that of the double - connection accessory system 1 for peritoneal dialysis; and a release device is also provided for releasing the double - connection accessory system 1 for peritoneal dialysis;

[0046] A connecting hose 7, one end of which is connected to the double - connection accessory system 1 for peritoneal dialysis, and the other end is connected to the buffer container 3; and

[0047] An impact plane 8 for receiving the double - connection accessory system 1 for peritoneal dialysis.

[0048] The detection device provided in this embodiment is used to test the impact resistance of the double - connection accessory system 1 for peritoneal dialysis when it bears a certain negative pressure. The principle is as follows. Let the target negative pressure borne by the double - connection accessory system 1 for peritoneal dialysis when it is impacted be P0. The detection device includes a buffer container 3 and a double - connection accessory system 1 for peritoneal dialysis. The two are connected by a connecting hose 7 to form a communicating vessel. Their positions are at different heights, with a liquid level difference H1. There is a tendency for the liquid to flow from the higher - positioned buffer container 3 to the lower - positioned double - connection accessory system 1 for peritoneal dialysis, but the air pump 2 provides a negative pressure P1 to keep the liquid relatively static, and the negative pressure P1 is large enough to make the double - connection accessory system 1 for peritoneal dialysis receive the target negative pressure P0. When the double - connection accessory system 1 for peritoneal dialysis is subjected to the negative pressure and deforms, its elastic force has a tendency to make the liquid flow into the double - connection accessory system 1 for peritoneal dialysis, and the deformation elastic force is equal to the absolute value of the target negative pressure P0 it receives. Since the double - connection accessory system 1 for peritoneal dialysis is a soft and airtight container, and there is no gas in the connecting hose 7 and the double - connection accessory system 1 for peritoneal dialysis, both of them are subjected to 1 unit of atmospheric pressure (1 atm), and the atmospheric pressure has a tendency to make the liquid flow back to the buffer container 3. To sum up, when the liquid level in the communicating vessel is stable and motionless, the forces in both the inflow and the back - flow aspects reach equilibrium, that is, the sum of the liquid - level difference pressure and the elastic tension (i.e., the absolute value of the target negative pressure P0 received by the double - connection accessory system 1 for peritoneal dialysis) is equal to the sum of the absolute value of the negative pressure of the air pump 2 and 1 unit of atmospheric pressure. Let the liquid density be ρ and the acceleration due to gravity be g, then the absolute value of the negative pressure of the air pump 2 |P1| = ρgH1+|P0| - 1 atm.

[0049] When the double - connection accessory system 1 for peritoneal dialysis is released and freely drops onto the impact plane 8, the double - connection accessory system 1 for peritoneal dialysis is impacted while bearing the maximum negative pressure, and its components should maintain airtightness and should not leak. After standing for 60 - 120 s after landing, if there is liquid leakage, the air pressure in the buffer container 3 will drop, and the drop value is recorded as the vacuum - degree loss value △P. If the vacuum - degree loss value is greater than 1% - 2% of the pressure value after the first drop, the impact resistance is unqualified.

[0050] In this embodiment, the maximum negative pressure that the double - connection accessory system 1 for peritoneal dialysis can withstand is simulated by the pressure difference of the liquid levels in a communicating vessel. The impact resistance of the double - connection accessory system 1 for peritoneal dialysis is tested by whether there is leakage after free - fall impact. The reading of the pressure gauge 4 of the air pump 2 is used to assist in the calculation. The operation and calculation are simple, and the accurate evaluation of the impact resistance of the double - connection accessory system 1 for peritoneal dialysis in a falling scenario with a certain negative pressure is realized.

[0051] The installation height of the double - connection accessory system 1 for peritoneal dialysis is 0.7 m. This height range is used to simulate the height at which the double - connection accessory system 1 for peritoneal dialysis falls from a table or chair in a clinical use scenario.

[0052] The height difference between the buffer container 3 and the double - connection accessory system 1 for peritoneal dialysis does not exceed 1.2 m. The above - mentioned height difference does not affect the height difference after free - fall, so it can be adjusted as needed. The height difference not exceeding 1.2 m can prevent the detection device from being higher than the ceiling, which is convenient for the test to be carried out.

[0053] The overall length of the hose is 2.2 m; there is a redundant part on the hose that can be extended and straightened, with a length of 1 m. The length of the hose should be greater than the height difference between the buffer container 3 and the double - connection accessory system 1 for peritoneal dialysis, and there should still be redundancy after the double - connection accessory system 1 for peritoneal dialysis lands.

[0054] The support frame 5 is provided with a height scale 6 and a height adjustment device. It is convenient to automatically record test data.

[0055] The negative pressure provided by the air pump 2 ranges from 0 to - 90 kPa, and the negative - pressure adjustment accuracy reaches - 0.1 kPa.

[0056] The detection device further includes an environmental temperature detection device and a timer. According to the current detection standard, the test is carried out at 20 - 30 °C.

[0057] The usage method of the above - mentioned detection device includes the following steps:

[0058] S1. Inject liquid into the connecting hose 7 and the double - connection accessory system 1 for peritoneal dialysis and discharge the gas. Inject liquid into the buffer container 3 and retain the gas. Connect one end of the connecting hose 7 to the double - connection accessory system 1 for peritoneal dialysis, and fix the other end below the liquid level of the buffer container 3; connect the top of the buffer container 3 to the air pump 2 and the pressure gauge 4;

[0059] S2. Place the double - connection accessory system 1 for peritoneal dialysis on the impact plane 8. Install the buffer container 3 above the impact plane 8 through the support frame 5. The height difference between the liquid level of the buffer container 3 and the impact plane 8 is H1. Let the liquid density be ρ and the acceleration due to gravity be g. Let the target negative pressure that the bag bears during the landing impact be P0. Set the negative pressure P1 of the air pump 2 in the control device, |P1| = ρgH1+|P0| - 1 atm. Open the air pump 2 and close the air pump 2 after the reading of the pressure gauge 4 stabilizes.

[0060] S3. Lift the double - connection accessory system 1 for peritoneal dialysis and install it at a height H2 above the impact plane 8 through the support frame 5, and H1 > H2. Remove the double - connection accessory system 1 for peritoneal dialysis and freely drop it from the height H2 to the impact plane 8 at normal temperature. There should be no leakage.

[0061] S4. Measure and record the reading of the pressure gauge 4 after 60 - 120 s after the impact as P2. Calculate the vacuum degree loss value △P = P1 - P2. If △P is not greater than 1% - 2% of P1, the impact resistance is qualified.

[0062] The range of the target negative pressure P0 is - 50 kPa ≤ P0 ≤ - 90 kPa.

[0063] The range of the height H2 is 0.5 m ≤ H2 ≤ 1 m.

[0064] The detection device for the leakage and impact resistance of the double - connection accessory system 1 for peritoneal dialysis provided in this embodiment uses the pressure difference of the liquid levels in the communicating vessels to simulate the maximum negative pressure that the double - connection accessory system 1 for peritoneal dialysis can bear. It tests the impact resistance of the double - connection accessory system 1 for peritoneal dialysis by whether there is leakage after free - fall impact, and assists in the calculation through the reading of the pressure gauge 4 of the air pump 2, realizing the accurate evaluation of the impact resistance of the double - connection accessory system 1 for peritoneal dialysis in the falling scenario under a certain negative pressure. This device can realize automatic operation, reduce human error, is simple and fast to operate, is conducive to the automatic recording of test data, shortens the test time, saves human resources, improves the credibility of measurement data, and is convenient for product quality traceability.

[0065] Obviously, the above - mentioned embodiments of the present utility model are only examples for clearly explaining the technical solutions of the present utility model, rather than limitations on the specific implementation manners of the present utility model. Any modifications, equivalent replacements, and improvements made within the spirit and principle of the claims of the present utility model shall be included within the protection scope of the claims of the present utility model.

Claims

1. A detection device for leakage and impact resistance of a double - connection accessory system for peritoneal dialysis, characterized in that, Comprising: A dual - connection accessory system for peritoneal dialysis; An air pump for providing negative pressure; A control device for setting pressure and controlling the air pump; A buffer container, which is a sealed container, filled with liquid inside and having an air cavity; A pressure gauge for monitoring the air pressure inside the buffer container; A support frame for respectively installing the buffer container and the dual - connection accessory system for peritoneal dialysis, the installation position of the buffer container being higher than that of the dual - connection accessory system for peritoneal dialysis; and a release device is also provided for releasing the dual - connection accessory system for peritoneal dialysis; A connecting hose, one end of which is connected to the dual - connection accessory system for peritoneal dialysis and the other end is connected to the buffer container; And An impact plane for receiving the dual - connection accessory system for peritoneal dialysis.

2. The leakage and impact resistance detection device for a double - connection accessory system for peritoneal dialysis according to claim 1, characterized in that, The installation height of the dual - connection accessory system for peritoneal dialysis is 0.5 - 1 m.

3. The leakage and impact resistance detection device for a double - connection accessory system for peritoneal dialysis according to claim 1, characterized in that, The height difference between the buffer container and the dual - connection accessory system for peritoneal dialysis does not exceed 1.2 m.

4. The leakage and impact resistance detection device for a double - tube attachment system for peritoneal dialysis according to claim 1, wherein, The overall length of the hose is 0.5 - 2.2 m; the hose has a redundant part that can be extended and straightened, with a length of 0.5 - 1 m.

5. The detecting device for leakage and shock resistance of a double - connection accessory system for peritoneal dialysis according to claim 1, characterized in that, The support frame is provided with a height measuring device and a height adjusting device.

6. The detection device for leakage and impact resistance of a double - connection accessory system for peritoneal dialysis according to claim 1, characterized in that, The negative pressure provided by the air pump ranges from 0 to - 90 kPa, and the negative pressure adjustment accuracy reaches - 0.1 kPa.

7. The leakage and impact resistance detection device for a double - connection accessory system for peritoneal dialysis according to claim 1, characterized in that, It also includes an ambient temperature detection device and a timer.

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