A device for testing the balloon slippage force of a balloon catheter.

Abstract

This invention discloses a device for testing the balloon slippage force of a balloon catheter, belonging to the field of medical device testing. The device includes: a test container, which can contain a constant-temperature liquid maintained at 37℃±1℃; the balloon catheter to be tested passes through the test container and is fixed by a clamping mechanism; and a loading assembly, which includes an actuator, a mechanical sensor module, and an inflation device. The actuator is connected to the guidewire port of the balloon catheter through the mechanical sensor module, and the inflation device is connected to the water inlet of the balloon catheter for controlling the inflation and deflation of the balloon catheter. The device for testing the balloon slippage force of a balloon catheter provided by this invention simulates a constant-temperature liquid and artificial blood vessel environment, and can quantitatively output the slippage force curve of the balloon catheter, significantly improving the accuracy and repeatability of the test.

Description

Technical Field

[0001] This utility model relates to a device for testing the balloon slippage force of a balloon catheter, belonging to the field of medical device testing. Background Technology

[0002] In interventional vascular treatment, balloon catheters are commonly used to dilate narrowed or blocked segments of blood vessels to restore local blood flow. Common causes of vascular stenosis or occlusion include plaque deposition due to atherosclerosis, thrombosis, and vascular wall calcification. Because the inner wall of diseased blood vessels often contains uneven plaque buildup or sclerotic tissue, and because balloon catheters, with their relatively low coefficient of friction due to their intima-covered surface and the flexible material of the balloon itself, are prone to axial slippage or displacement within the vessel during high-pressure dilation. When encountering thrombi or calcified segments, the balloon is more likely to deviate from its intended dilation position due to uneven local stress. This slippage not only reduces the dilation effect but may also lead to inaccurate dilation of the lesion, increasing surgical risks and even causing vascular injury or secondary stenosis.

[0003] Currently, testing methods for the anti-slip performance of balloon catheters during dilation remain limited. Most tests focus only on the balloon's dilation diameter, pressure tolerance, or compliance, lacking a systematic and quantitative assessment method for the balloon's slippage tendency and anti-slippage ability during dilation. Therefore, there is an urgent need for a testing device that can simulate the vascular environment and quantitatively detect the slippage force of the balloon during dilation. By monitoring and analyzing the force conditions during dilation in real time, the anti-slip performance of balloon catheters can be objectively and accurately evaluated, providing a more reliable reference for product design improvement and clinical application. Utility Model Content

[0004] To address the current lack of testing devices capable of simulating the vascular environment and quantitatively detecting the slippage force of a balloon during inflation, this invention provides a device for testing the balloon slippage force of a balloon catheter, comprising: A test container, the interior of which can contain a constant-temperature liquid and maintain it at 37 ℃±1 ℃, through which the balloon catheter to be tested passes and is fixed by a clamping mechanism; The loading component includes an actuator, a mechanical sensor module, and an inflation device. The actuator is connected to the guidewire port of the balloon catheter through the mechanical sensor module, and the inflation device is connected to the water inlet of the balloon catheter for controlling the inflation, deflation, and pressure measurement of the balloon catheter.

[0005] Furthermore, the test container is a closed test cavity structure (artificial blood vessel) with openings at both ends, and the openings are fitted with matching end caps, with the clamping structure mounted on the end caps.

[0006] Furthermore, the clamping structure is a soft bushing, which is used to protect the balloon catheter from being crushed and to prevent slippage.

[0007] Furthermore, the actuator is a linear drive device, which can be an electric push rod.

[0008] Furthermore, the mechanical sensor module is a detachable structure that can be plugged into and connected to the proximal end of the balloon catheter and the actuator, respectively.

[0009] The beneficial effects of this utility model are: By setting up the test container, the environment of constant temperature liquid and artificial blood vessels can be simulated, which is closer to the clinical reality. At the same time, the balloon catheter is clamped and installed on the test container by the clamping mechanism. The balloon catheter is filled with liquid and vented by the inflation device. Then, the actuator provides power to pull the balloon catheter with the dynamic sensor module to perform anti-dislodgement force test. This solves the problem that the existing technology lacks a test device that can simulate the vascular environment and realize quantitative detection of balloon slippage force during expansion. The balloon slippage force test device of this utility model application has a compact structure, is easy to operate, and can quantitatively output the slippage force curve of the balloon catheter, which significantly improves the accuracy and repeatability of the test. Attached Figure Description

[0010] Figure 1 This is a schematic diagram of the overall structure of the device for testing the balloon slippage force of a balloon catheter provided by this utility model; Figure 2 This is a front view of the device for testing the balloon slippage force of a balloon catheter provided by this utility model; Figure 3 This is a top view of the device for testing the balloon slippage force of a balloon catheter provided by this utility model; Explanation of reference numerals in the attached figures: 1. Test container; 2. End cap; 3. Clamping mechanism; 4. Balloon catheter; 5. Actuator; 6. Mechanical sensor module; 7. Filling device; 8. Electronic box. Detailed Implementation

[0011] The following is a detailed description of this utility model.

[0012] Example 1 This embodiment provides a device for testing the balloon slippage force of a balloon catheter. See [link to relevant documentation]. Figures 1 to 3 As shown, the device includes a test container and a loading component: Test container 1 is a closed test chamber structure (artificial blood vessel) with openings at both ends. Test container 1 is made of metal or transparent plexiglass, with matching end caps 2 covering the openings. The end caps 2 are disc-shaped and fixed to the openings of test container 1. The test chamber structure can contain a constant-temperature liquid and maintain it at 37℃±1℃ to simulate actual clinical conditions. The constant-temperature liquid can be constant-temperature water. The temperature measuring container 1 is maintained at a constant temperature by a heating element or a constant-temperature water jacket surrounding its outer wall, and a temperature controller.

[0013] The balloon catheter 4 to be tested is installed inside an artificial blood vessel model, which penetrates the opening of the test container 1 and is clamped and fixed by the clamping structure 3. The artificial blood vessel is a silicone or polyurethane tube containing calcified stenosis and a calcified model, and its interior is filled with static liquid to simulate the internal environment of human blood vessels. The end cap 2 has a central through-hole. The clamping mechanism 3 is fitted onto the outside of the balloon catheter 4, passes through this central through-hole, and is fixed in place. An O-ring is provided at the through-hole to seal the gap between the artificial blood vessel model containing the balloon catheter 4 and the end cap 2. Specifically, the clamping mechanism 3 can be a soft bushing, which can be made of soft silicone or PU material. This soft bushing protects the balloon catheter 4 from pressure damage and prevents slippage.

[0014] The loading component includes an actuator 5, a force sensor module 6, and an inflation device 7. The actuator 5 is a linear drive device, which can be an electric actuator, such as a combination of a drive motor and a lead screw / linear slide. The force sensor module 6 can be an S-beam tension / compression sensor, used to measure the slippage force of the balloon catheter during inflation in real time. The force sensor module 6 is fixedly installed at the output end of the actuator 5 and is detachable, allowing it to be plugged into both the proximal end of the balloon catheter 4 and the actuator 5. Both ends have standard Luer interfaces, allowing it to be inserted between the proximal end of the catheter and the actuator, enabling force measurement without being fixed to the catheter body, facilitating testing with different models of balloon catheters. The inlet of the balloon catheter 4 is connected to one end of the inflation device 7, used to control the inflation, deflation, and pressure measurement of the balloon catheter 4. The second end of the inflation device 7 can be connected to a syringe or a micro-pump (for inflating the balloon catheter 4).

[0015] Furthermore, a temperature sensor is installed inside the test chamber to monitor the temperature of the liquid inside the chamber in real time. An electronic box 8 is also installed inside the test container. The electronic box 8 includes a power module, a signal amplification module, a controller module, and a display module. The power module provides power to the mechanical sensor module 6 and the temperature sensor. The data collected by the sensor modules is amplified and processed by the signal amplification module before being sent to the controller module for further processing. The slip force and temperature data are then displayed in real time on the screen.

[0016] The advantages of the device for testing the balloon slippage force of a balloon catheter disclosed in this utility model application are as follows: 1) It can simulate the environment of constant temperature liquid and artificial blood vessels, which is closer to the clinical reality; 2) The balloon catheter model can be quickly replaced and can be adapted to healthy blood vessel models and various diseased blood vessel models (such as calcification, thrombosis, etc.). 3) The mechanical sensor module adopts a detachable structure, which facilitates rapid switching between different balloon catheters and improves testing efficiency; 4) The overall device has a compact structure and is easy to operate. It can quantitatively output the slippage force curve of the balloon catheter, which significantly improves the accuracy and repeatability of the test.

[0017] The working principle of this utility model: During testing, the balloon catheter 4 is first placed inside the artificial blood vessel model. The inflation device 7 inflates the balloon catheter 4 with water, expanding and fixing it within the model. Then, the actuator 5 provides a linear driving force to stretch the balloon catheter 4 proximally. The mechanical sensor module 6 pulls the balloon catheter 4, causing it to slip out of the artificial blood vessel model. The slippage force throughout the process is monitored and collected by the mechanical sensor module 6, enabling the quantitative output of the balloon catheter 4's slippage force curve, significantly improving the accuracy and repeatability of the test.

[0018] Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make various modifications and alterations without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention should be determined by the claims.

Claims

1. An apparatus for testing balloon slippage force of a balloon catheter, characterized by, It includes: A test container, the interior of which can contain a constant-temperature liquid and maintain it at 37 ℃±1 ℃, through which the balloon catheter to be tested passes and is fixed by a clamping mechanism; The loading component includes an actuator, a mechanical sensor module, and an inflation device. The actuator is connected to the proximal guidewire port of the balloon catheter via the mechanical sensor module. The inflation device is connected to the water inlet of the balloon catheter and is used to control the inflation, deflation, and pressure measurement of the balloon catheter.

2. The device for testing balloon slippage force of a balloon catheter according to claim 1, wherein The test container is a closed test cavity structure with openings at both ends. The openings are fitted with matching end caps, and the clamping mechanism is mounted on the end caps.

3. The device for testing balloon slippage force of a balloon catheter according to claim 1, wherein The clamping mechanism is a soft bushing, which is used to protect the balloon catheter from being crushed and to prevent slippage.

4. The device of claim 1, wherein, The actuator is a linear drive device, which can be an electric push rod.

5. The device of claim 1, wherein, The mechanical sensor module is a detachable structure that can be plugged into and connected to the proximal guidewire port of the balloon catheter and the actuator, respectively.

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