Duct power injection flow and bursting pressure tester

Abstract

The utility model discloses a catheter power injection flow and bursting pressure tester, which comprises a constant-temperature water tank, an equipment main body and a balloon expansion diameter measuring jig, the constant-temperature water tank comprises a heating main body, a metal protective shell is fixed at the top of the heating main body, a constant-temperature water outlet pipe is arranged on the heating main body, and a display screen and a switch are arranged on the heating main body. A power plug is mounted on the heating main body; the utility model relates to the technical field of medical instrument inspection, in particular to a catheter power injection flow and bursting pressure tester, which comprises a balloon expansion diameter measuring jig and a pressure tube fixing block, and is characterized in that the balloon expansion diameter measuring jig comprises a hand screw used for placing a tested product, and the tested product is provided with the pressure tube fixing block. The problems that an existing tester is complex in system, large in equipment size, large in weight, high in cost and poor in durability; later-stage maintenance is difficult, and use cannot be achieved in special environments; operation is complex, small products cannot be tested, and danger coefficient after aging is high; and the problems of inaccurate or uncontrollable pressure and flow control, incomplete functions, loud noise and the like are solved.

Description

Technical Field

[0001] This utility model relates to the field of medical device testing technology, specifically a catheter dynamic injection flow rate and burst pressure tester. Background Technology

[0002] In clinical applications, catheter-based products are commonly used to rapidly and stably deliver contrast agents, high-concentration drugs, and other liquids into patients under high pressure to achieve clinical purposes such as angiography and treatment. Common dynamic injection catheters include angiography catheters, microcatheters, support catheters, central venous catheters, implantable drug delivery devices, and some peripheral catheters with cannula-like structures. However, there are many types of dynamic injection catheters used in clinical applications, with significant differences in catheter size and injection pressure, requiring further research and development of specific testing protocols and experimental devices. Appendix F of the medical device industry standard YY0285.1-2017 provides a standardized overview of the test requirements for burst pressure testing under static conditions. During the test, the test fluid must be supplied to the test catheter at a stable rate. If the fluid cannot be supplied at a stable flow rate, fluctuations in flow rate may cause pressure fluctuations, leading to leakage or bursting of the test catheter, resulting in inaccurate test results. Meanwhile, when testing the burst pressure of the conduit under static conditions, the fluid in the test chamber needs to be kept at a constant temperature during the test, and reliable preventive and safety precautions need to be taken for the conduit to protect the test operator from the dangers of pressurization system failure and fluid leakage under high pressure.

[0003] Existing technologies suffer from the following drawbacks and shortcomings: Existing catheter-based dynamic injection flow and burst pressure testing instruments are cumbersome to operate manually and lack complete functionality; the equipment is too heavy and bulky, unsuitable for operation or transportation in small rooms; they require external air, hydraulic, and high-pressure power sources, resulting in stringent environmental requirements and poor environmental compatibility; the mechanical structure is complex, costly, and difficult to maintain; they are noisy, and pose safety hazards after structural aging; and the structure is not rigorous enough, resulting in poor durability. Therefore, we propose a catheter-based dynamic injection flow and burst pressure testing instrument to address these problems. Utility Model Content

[0004] To address the shortcomings of existing technologies, this invention provides a catheter dynamic injection flow rate and burst pressure tester, which solves the existing problems.

[0005] To achieve the above objectives, this utility model provides the following technical solution: a catheter dynamic injection flow rate and burst pressure tester, comprising a constant temperature water tank, a main body of the device, and a balloon expansion diameter measuring fixture.

[0006] The constant temperature water tank includes a heating body, a metal protective shell fixed to the top of the heating body, a constant temperature water outlet pipe installed on the heating body, a display screen and a switch installed on the heating body, and a power plug installed on the heating body.

[0007] The balloon inflation diameter measuring fixture includes a hand-tightening screw for placing the product under test and a stainless steel base. A pressure tube fixing block is installed on the product under test, and a hand-tightening screw is installed on the pressure tube fixing block. A dial indicator mounting block is fixed on the stainless steel base, and a dial indicator is installed on the dial indicator mounting block.

[0008] The main body of the device includes a stainless steel shell, on which a printer and a touch screen are installed. A high-voltage connecting pipe is installed on the stainless steel shell, and a conduit connector is installed on the high-voltage connecting pipe. An instrument switch, an instrument fuse, and an instrument power plug are installed on the back of the stainless steel shell.

[0009] A device mounting plate is fixed inside the stainless steel casing. A stepper motor is fixed on the device mounting plate. A reducer is installed at the output end of the stepper motor. The reducer is mounted on a reducer mounting block. A lead screw fixing seat is fixed inside the stainless steel casing. A lead screw nut seat is provided on one side of the lead screw fixing seat. A sensor stop is provided on one side of the lead screw nut seat. A lead screw nut is installed on the lead screw nut seat. A ball screw is internally threaded into the lead screw nut. One end of the ball screw passes through the lead screw fixing seat and is connected to the output end of the reducer via a metal chain-sprocket transmission. A piston rod is fixed on the lead screw nut seat. One end of the piston rod is installed inside a compression cylinder. A pressure transmitter is installed on the compression cylinder. A first high-pressure fluid valve and a second high-pressure fluid valve are installed on the compression cylinder. The second high-pressure fluid valve is installed on one side of the compression cylinder. An outlet and an inlet are installed on the compression cylinder.

[0010] Preferably, anti-slip pads are fixed to the four corners of the lower wall of the stainless steel shell.

[0011] Preferably, the outlet and inlet are fixed on the inlet / outlet fixing block, which is used to fix the outlet and inlet to prevent them from sliding.

[0012] Preferably, an upper limit switch and a lower limit switch are installed inside the stainless steel housing to limit the forward and backward safe travel of the ball screw.

[0013] Preferably, the device mounting plate is equipped with a stepper motor controller, a 24V power supply and a microcontroller control board. The stepper motor controller is used to control the output of the stepper motor, the 24V power supply is used to power the stepper motor and other components, and the microcontroller control board is used to control the operation of the device.

[0014] Preferably, the stepper motor controller, the 24V power supply, and the microcontroller control board are fixed with an electrical protective frame for their protection.

[0015] Beneficial effects

[0016] This invention provides a catheter-based dynamic injection flow rate and burst pressure tester. Compared with the prior art, it has the following advantages:

[0017] 1. This catheter-based dynamic injection flow rate and burst pressure tester, with a constant temperature water tank including a metal protective shell and a heating element, has the following functions:

[0018] Function 1: Placing the test product in a constant temperature water tank during the explosion test can prevent water from spraying everywhere after the explosion.

[0019] Function 2: Placing the test product in a constant temperature water tank during the explosion test can prevent loud noise and the risk of injury after the explosion;

[0020] Function 3: The equipment can provide a constant temperature solution when performing the "power injection flow and pressure test".

[0021] 2. This catheter-based dynamic injection flow rate and burst pressure tester, the main body of which includes a stainless steel shell, printer, etc., has the following functions:

[0022] 1) Equipped with a touch screen, the program can be written to set the product model, test items, etc. For example, when testing burst pressure, the time will be generated; the pressure value curve will be read and recorded after bursting; when testing flow rate, pressure value and flow rate curve will be generated; equipped with a printer, the test report will be printed out on paper after each test; equipped with wireless communication, it is convenient to remotely control during later maintenance or updates.

[0023] 2) This equipment features a compact internal aperture, high space utilization, and stable connections between components. The use of a metal chain-sprocket drive ensures strength while preventing leakage caused by misalignment between the piston rod and cylinder due to dimensional deviations during assembly or processing. It also reduces friction between components, significantly extending the equipment's lifespan. The use of a stepper motor with a high-strength, high-reduction-ratio reducer generates high-torque power output, avoiding the problem of excessively large or heavy stepper motors or reducers under high torque conditions. The axial force output section employs a high-strength lead screw nut and ball screw with a shaft diameter of 20mm. Ball bearings at both ends of the lead screw limit its sway and prevent physical damage to surrounding components. The ball screw and piston rod are coaxial and output force in the same direction, avoiding structural lever force losses and minimizing force transmission losses, greatly improving instrument stability. Upper and lower limit switches are added during ball screw movement to prevent physical damage caused by overtravel.

[0024] 3. This catheter dynamic injection flow and burst pressure tester, by setting a balloon expansion diameter measuring fixture, including the product to be tested, a hand-tightening screw, etc., is suitable for the change of the diameter of the balloon at the head of the catheter under pressure. The pressure gauge accuracy is 0.001mm. When in use, the product to be tested is placed in the stainless steel base groove, and the balloon is located below the test block under the dial gauge.

[0025] This utility model solves the problems of existing solutions, such as complex systems, large and heavy equipment, high cost, poor durability, difficult maintenance, inability to be used in special environments, complicated operation, inability to test small products, high risk factor after aging, inaccurate or uncontrollable pressure and flow control, or incomplete functions and high noise. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of the overall structure of this utility model;

[0027] Figure 2 This is a schematic diagram of the overall structure of the constant temperature water tank of this utility model;

[0028] Figure 3 This is a schematic diagram of the overall structure of the balloon inflation diameter measuring fixture of this utility model;

[0029] Figure 4 This is a first-view structural diagram of the main body of the device of this utility model;

[0030] Figure 5 This is a second-view structural diagram of the main body of the device of this utility model;

[0031] Figure 6 This is a schematic diagram of the internal structure of the main body of the device of this utility model.

[0032] In the diagram: 1. Constant temperature water tank; 11. Metal protective casing; 12. Heating unit; 13. Constant temperature water outlet pipe; 14. Display screen; 15. Switch; 16. Power plug; 2. Equipment body; 21. Stainless steel casing; 22. Printer; 23. Touch screen; 24. High-pressure connecting pipe; 25. Conduit connector; 26. Anti-slip pad; 27. Instrument switch; 28. Instrument fuse; 29. ​​Instrument power plug; 219. Lead screw fixing seat; 220. Lead screw nut seat; 221. Upper limit switch; 222. Sensor stop; 223. Lead screw nut; 224. Ball screw; 225. Lower limit switch; 226. Piston rod; 227. Compression cylinder; 22 8. Pressure transmitter; 229. First high-pressure fluid valve; 230. Second high-pressure fluid valve; 231. Wireless receiver; 232. Liquid outlet; 233. Liquid inlet; 234. Liquid inlet / outlet fixing block; 235. Metal chain-sprocket; 236. Reducer mounting block; 237. Reducer; 238. Device mounting plate; 239. Stepper motor; 240. Electrical protective frame; 241. Stepper motor controller; 242. 24V power supply; 243. Microcontroller control board; 3. Balloon inflation diameter measuring fixture; 31. Product under test; 32. Pressure tube fixing block; 33. Hand screw; 34. Stainless steel base; 35. Dial indicator mounting block; 36. Dial indicator. Detailed Implementation

[0033] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0034] Please see Figure 1-6 The present invention provides the following technical solution:

[0035] A catheter-based dynamic injection flow rate and burst pressure tester includes a constant temperature water tank, a main body of the device, and a fixture for measuring the inflation diameter of a balloon.

[0036] The constant temperature water tank includes a heating body, a metal protective shell fixed to the top of the heating body, a constant temperature water outlet pipe installed on the heating body, a display screen and a switch installed on the heating body, and a power plug installed on the heating body.

[0037] The balloon inflation diameter measuring fixture includes a hand-tightening screw for placing the product under test and a stainless steel base. A pressure tube fixing block is installed on the product under test, and a hand-tightening screw is installed on the pressure tube fixing block. A dial indicator mounting block is fixed on the stainless steel base, and a dial indicator is installed on the dial indicator mounting block.

[0038] The main body of the equipment includes a stainless steel shell, on which a printer and a touch screen are installed. A high-pressure connecting pipe is installed on the stainless steel shell, and a conduit connector is installed on the high-pressure connecting pipe. The instrument switch, instrument fuse, and instrument power plug are installed on the back of the stainless steel shell.

[0039] A device mounting plate is fixed inside the stainless steel casing. A stepper motor is fixed on the device mounting plate, and a reducer is installed at the output end of the stepper motor. The reducer is mounted on a reducer mounting block. A lead screw fixing seat is fixed inside the stainless steel casing. A lead screw nut seat is provided on one side of the lead screw fixing seat. A sensor stop is provided on one side of the lead screw nut seat. A lead screw nut is installed on the lead screw nut seat. A ball screw is internally threaded into the lead screw nut. One end of the ball screw passes through the lead screw fixing seat and is connected to the output end of the reducer via a metal chain-sprocket drive. A piston rod is fixed on the lead screw nut seat. One end of the piston rod is installed inside a compression cylinder. A pressure transmitter is installed on the compression cylinder. A first high-pressure fluid valve and a second high-pressure fluid valve are installed on the compression cylinder. The second high-pressure fluid valve is installed on one side of the compression cylinder. An outlet and an inlet are installed on the compression cylinder.

[0040] The device mounting plate is equipped with a stepper motor controller, a 24V power supply, and a microcontroller control board. The stepper motor controller is used to control the output of the stepper motor, the 24V power supply is used to power the stepper motor and other components, and the microcontroller control board is used to control the operation of the equipment. The stepper motor controller, the 24V power supply, and the microcontroller control board are all fixed with an electrical protective frame for their protection.

[0041] In this embodiment:

[0042] (I) Test of burst pressure under static conditions (testing other small cavity products requires the use of corresponding fixing clamps; this test focuses on intravascular catheters)

[0043] 1. Connect the high-pressure connecting pipe to the liquid outlet of the equipment, connect the conduit to the high-pressure connecting pipe, open the constant temperature water tank, and immerse the conduit and the end of the high-pressure connecting pipe into the constant temperature water tank together;

[0044] 2. Power on the constant temperature water tank and the main body of the equipment respectively, and turn on the equipment switch to put the equipment into standby mode (solenoid valves 1 and 2 are both closed);

[0045] 3. Connect the test tubing to the high-pressure connection tubing (the connector is a 2-point male male thread to Luer female thread male connector);

[0046] 4. Click the liquid addition button on the touch screen (at this time, the liquid addition solenoid valve inside the main body of the equipment is in the open state, the liquid outlet control solenoid valve is in the closed state, and the screw returns to the set liquid addition point). The solution flows from top to bottom into the steel body and fills the entire pipeline. Visually observe that no air bubbles are generated in the guide tube and after a certain time (this time is obtained during debugging, and the liquid addition completion time is longer than the actual time), the liquid addition solenoid valve closes, the guide tube is sealed, and the entire guide tube and the high-pressure connection pipe end are submerged into the constant temperature water tank and the water tank lid is closed.

[0047] 4. Connect the test tubing to the high-pressure connecting pipe (the connector is a 2-point male male to Luer female male thread connector) and immerse the entire tubing and the tail of the high-pressure connecting pipe into the constant temperature water tank and close the water tank lid.

[0048] 5. Click the test button. At this time, the internal motor of the equipment starts to rotate, and the sprocket and chain drive the lead screw slider to pressurize the pressure bar. The pressure transmitter transmits the received data to the control center in real time and displays the specific values ​​and time and pressure curves on the touch screen until the pressure reaches the product's pressure resistance limit, the conduit ruptures, the pressure data returns to zero or drops sharply, the system identifies and records the peak difference, and automatically stops running after the set time (the later period of operation is to continue to replenish the end solution lost due to the explosion, so that it is in a full state, and when adding liquid again, only the liquid lost in the cylinder needs to be replenished). This equipment is set with two stopping methods: stopping after a certain time and stopping when the lower limit is triggered by the switch. After stopping, the pressure value returns to zero, the liquid adding solenoid valve opens, the motor reverses and the water flow automatically follows, causing the motor to return to the origin, the liquid adding solenoid valve closes, and waits for the second test.

[0049] (II) Testing of flow rate and pressure during dynamic injection

[0050] 1. Connect the high-pressure connecting pipe to the liquid outlet of the equipment, connect the conduit to the high-pressure connecting pipe, turn on the constant temperature water bath, and set its temperature value;

[0051] 2. Power on the constant temperature water tank and the main body of the equipment respectively, and turn on the equipment switch to put the equipment into standby mode (solenoid valves 1 and 2 are both closed);

[0052] 3. Place the constant temperature water tank at a position slightly higher than the main body of the equipment, and connect the solution in the constant temperature water tank to the liquid inlet of the equipment;

[0053] 4. Connect the test tubing to the high-pressure connecting pipe (the connector is a 2-point male male to Luer female male thread adapter) and place the entire tubing and the tail of the high-pressure connecting pipe together on the test base.

[0054] 5. Click the liquid filling button on the touch screen (at this time, the liquid filling solenoid valve inside the main body of the equipment is in the open state, the liquid outlet control solenoid valve is in the closed state, and the screw returns to the set liquid filling point). The constant temperature solution flows from top to bottom into the steel body and fills the entire pipeline. After a period of time, the internal temperature of the pipeline is consistent with that of the constant temperature chamber, and then the liquid filling solenoid valve closes.

[0055] 6. Secure the tubing in the water tank.

[0056] 7. Click the test button. At this time, the internal motor of the device starts to rotate and the sprocket and chain drive the lead screw slider to start pressurizing the pressure bar. The pressure transmitter transmits the received data to the control center in real time and displays the specific values ​​and time and pressure curves on the touch screen until the pressure reaches the nominal pressure of the product. The pressure output is adjusted in real time according to the pressure status. After the test is completed, the solution mass is recorded and the flow rate is calculated.

[0057] (III) Liquid Leakage Test under Pressure

[0058] 1. Connect the high-pressure connecting pipe to the liquid outlet of the equipment, connect the conduit to the high-pressure connecting pipe, turn on the constant temperature water bath, and set its temperature value;

[0059] 2. Power on the constant temperature water tank and the main body of the equipment respectively, and turn on the equipment switch to put the equipment into standby mode (solenoid valves 1 and 2 are both closed);

[0060] 3. Place the constant temperature water tank at a position slightly higher than the main body of the equipment, and connect the solution in the constant temperature water tank to the liquid inlet of the equipment;

[0061] 4. Connect the test tubing to the high-pressure connecting pipe (the connector is a 2-point male male to Luer female male thread adapter) and place the entire tubing and the tail of the high-pressure connecting pipe together on the test base.

[0062] 5. Click the liquid addition button on the touch screen (at this time, the liquid addition solenoid valve inside the main body of the equipment is in the open state, the liquid outlet control solenoid valve is in the closed state, and the screw returns to the set liquid addition point). The constant temperature solution flows from top to bottom into the steel body and fills the entire pipeline. After a period of time, the internal temperature of the pipeline is consistent with that of the constant temperature chamber. Then the liquid addition solenoid valve closes and the conduit is sealed.

[0063] 6. Click the test button. At this time, the internal motor of the device starts to rotate, and the sprocket and chain drive the lead screw slider to start pressurizing the pressure bar. The pressure transmitter transmits the received data to the control center in real time and displays the specific values ​​and time-pressure curves on the touch screen until the pressure reaches the product's nominal pressure (e.g., 300KP, refer to standard YY 0285.1-2017) and holds for 30 seconds. Check the catheter / socket assembly (if any) and the catheter tubing for liquid leakage, for example, the formation of one or more droplets. Record whether any leakage has occurred (for hydrated intravascular catheters, the state before and after hydration should be considered).

[0064] Furthermore, any content not described in detail in this specification is existing technology known to those skilled in the art.

[0065] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0066] Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the present invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A catheter dynamic injection flow rate and burst pressure tester, comprising a constant temperature water tank (1), a main body (2), and a balloon expansion diameter measuring fixture (3), characterized in that: The constant temperature water tank (1) includes a heating body (12), a metal protective shell (11) is fixed on the top of the heating body (12), a constant temperature water outlet pipe (13) is installed on the heating body (12), a display screen (14) and a switch (15) are installed on the heating body (12), and a power plug (16) is installed on the heating body (12). The balloon inflation diameter measuring fixture (3) includes a hand-tightening screw (33) for placing the product under test (31) and a stainless steel base (34). A pressure tube fixing block (32) is installed on the product under test (31), and a hand-tightening screw (33) is installed on the pressure tube fixing block (32). A dial indicator mounting block (35) is fixed on the stainless steel base (34), and a dial indicator (36) is installed on the dial indicator mounting block (35). The main body (2) of the device includes a stainless steel shell (21), on which a printer (22) and a touch screen (23) are installed. A high-pressure connecting pipe (24) is installed on the stainless steel shell (21), and a conduit connector (25) is installed on the high-pressure connecting pipe (24). An instrument switch (27), an instrument fuse (28), and an instrument power plug (29) are installed on the back of the stainless steel shell (21). A device mounting plate (238) is fixed inside the stainless steel housing (21). A stepper motor (239) is fixed on the device mounting plate (238). A reducer (237) is installed at the output end of the stepper motor (239). The reducer (237) is mounted on a reducer mounting block (236). A lead screw fixing seat (219) is fixed inside the stainless steel housing (21). A lead screw nut seat (220) is provided on one side of the lead screw fixing seat (219). A sensor stop block (222) is provided on one side of the lead screw nut seat (220). A lead screw nut (223) is installed on the lead screw nut seat (220). A ball screw (223) is internally threaded into the lead screw nut (223). 24) One end of the ball screw (224) passes through the screw fixing seat (219) and is connected to the output end of the reducer (237) by a metal chain-sprocket (235). A piston rod (226) is fixed on the screw nut seat (220). One end of the piston rod (226) is installed in the compression cylinder (227). A pressure transmitter (228) is installed on the compression cylinder (227). A first high-pressure fluid valve (229) and a second high-pressure fluid valve (230) are installed on the compression cylinder (227). A second high-pressure fluid valve (230) is installed on one side of the compression cylinder (227). An outlet (232) and an inlet (233) are installed on the compression cylinder (227).

2. The catheter dynamic injection flow rate and burst pressure tester according to claim 1, characterized in that: Anti-slip pads (26) are fixed to the four corners of the lower wall of the stainless steel shell (21).

3. The catheter dynamic injection flow rate and burst pressure tester according to claim 1, characterized in that: The outlet (232) and inlet (233) are fixed on the inlet / outlet fixing block (234), which is used to fix the outlet (232) and inlet (233) to prevent them from sliding.

4. The catheter dynamic injection flow rate and burst pressure tester according to claim 1, characterized in that: The stainless steel housing (21) is equipped with an upper limit switch (221) and a lower limit switch (225) to limit the forward and backward safe travel of the ball screw (224).

5. The catheter dynamic injection flow rate and burst pressure tester according to claim 1, characterized in that: The device mounting plate (238) is equipped with a stepper motor controller (241), a 24V power supply (242), and a microcontroller control board (243). The stepper motor controller (241) is used to control the output of the stepper motor (239), the 24V power supply (242) is used to supply power to the stepper motor (239) and other components, and the microcontroller control board (243) is used to control the operation of the device.

6. The catheter dynamic injection flow rate and burst pressure tester according to claim 5, characterized in that: The stepper motor controller (241), 24V power supply (242) and single-chip microcomputer control board (243) are all fixed with an electrical protective frame (240) for their protection.

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