Analog device for radio frequency ablation tester and testing method

Abstract

The application belongs to the technical field of testing, and specifically provides a simulation device and a testing method for radio frequency ablation instrument testing. The simulation device for radio frequency ablation instrument testing comprises a water pool, a test model, a clamping mechanism and a driving mechanism. The test model is fixed in the water pool, and the driving mechanism drives the catheter to reciprocate along the test channel formed by the test model through the clamping mechanism to perform bending fatigue testing. The test model comprises a first test section and a second test section which are continuous but have opposite bending directions. During testing, the test section of the catheter can be subjected to bending fatigue testing in the first test section and the second test section in turn by changing the stroke range of the reciprocating motion of the test section of the catheter through the driving mechanism, and the rotation or re-clamping of the catheter is not required during the whole process. In this way, the manual operation steps are eliminated, which helps to realize the automation of the testing process, and the unattended operation can be realized during long-term durability testing.

Description

Technical Field

[0001] This application belongs to the field of testing technology, specifically a simulation device and testing method for testing radiofrequency ablation devices. Background Technology

[0002] Radiofrequency ablation is an interventional medical device used to treat diseases such as arrhythmia. In practical applications, it is necessary to use a radiofrequency ablation catheter to reach the lesion site such as the heart through a complex vascular path, and then deliver precise radiofrequency energy to the area through the radiofrequency ablation catheter to ablate abnormal tissue.

[0003] During the process of a radiofrequency ablation catheter (hereinafter referred to as the catheter) moving from the human blood vessel to the lesion site, the catheter will be subjected to repeated bending stress. In order to ensure product quality, relevant departments will conduct bending fatigue performance tests on radiofrequency ablation catheters, requiring that the catheter must not show any failure phenomena such as cracking or breakage after repeated push-pull and rotation tests simulating the in vivo environment.

[0004] In the prior art, the testing method for radiofrequency ablation device catheters is as follows: In a physiological saline environment at 37°C, the catheter is placed in a bending model with an inner diameter of about five millimeters. It is first pushed and pulled back and forth a specified number of times, and then the catheter is rotated at a certain angle (such as 180 degrees) and pushed and pulled back and forth again. This is to comprehensively simulate and evaluate the fatigue resistance of the catheter under bidirectional bending conditions.

[0005] like Figure 1 As shown, there are currently specialized bending fatigue testing devices available on the market for performing this test. These include a water tank, a vascular model with at least a 180° bend within the tank, and catheter clamps. After the clamps hold the catheter, the operator manually pushes and pulls the test end of the catheter back and forth within the model. After a specified number of pushes and pulls, the clamps are released, the catheter is rotated 180° to change the bending direction, the clamps are tightened, and the test is repeated. During this test, the operator needs to manually change the direction of the catheter and re-clamp it, which is inconvenient. Summary of the Invention

[0006] Based on the above-mentioned technical problems, this application provides a simulation device and testing method for testing radiofrequency ablation devices, in order to solve the technical problem that the existing technology requires manual completion of catheter reversal and re-clamping operations, which leads to inconvenience in operation.

[0007] To achieve the above objectives, the technical solution adopted in this application is as follows: In a first aspect, this application provides a simulation device for testing a radiofrequency ablation device, comprising: A water tank for holding 0.9% saline solution; A test model is set inside the water tank. The test model has a hollow test channel with an inner diameter of no more than 5 mm. The test channel has a first test section and a second test section arranged in sequence. The first test section and the second test section are both arc segments with a bending angle of no less than 90 degrees. The bending directions of the first test section and the second test section are opposite. A clamping mechanism, located at the inlet side of the test model, is used to clamp the catheter of the radiofrequency ablation device to be tested; and A drive mechanism, located above the water tank, is used to drive the clamping mechanism to reciprocate along the test direction.

[0008] In one possible implementation, the clamping mechanism includes: A first mounting bracket is disposed on the entrance side of the test model, and the drive mechanism is connected to the first mounting bracket; Two clamping blocks are disposed opposite to each other on the first mounting bracket. Each clamping block has a clamping groove on its adjacent side, forming a clamping space between the two clamping grooves for accommodating the conduit. A first driving member, disposed on the first mounting bracket, is used to drive the two clamping blocks to move closer or further apart from each other.

[0009] In one possible implementation, the clamping mechanism further includes: Two conveying wheels are disposed opposite to each other on the first mounting frame. The conveying wheels and the clamping block are spaced apart along the axial direction of the conduit. The conveying wheels and the first mounting frame rotate around a vertical axis, and a conveying space for accommodating the conduit is formed between the two conveying wheels. The second driving component, located on the first mounting bracket, is used to drive the two conveying wheels to rotate about their respective axes.

[0010] In one possible implementation, the water tank is provided with a guide rail along the testing direction, and the driving mechanism slides in cooperation with the guide rail; the radiofrequency ablation instrument testing simulation device further includes an imaging mechanism, which includes: A shooting rig is mounted above the pool; and A camera is mounted on the shooting bracket and positioned above the entrance side of the test model, with the camera's shooting end facing downwards; and The third driving component is located in the water tank and is used to drive the driving mechanism to move along the guide rail; During the test, for every preset number of reciprocating movements performed by the drive mechanism, the third drive component performs one reciprocating movement. The movement speed of the third drive component is less than that of the drive mechanism. During the reciprocating movement of the third drive component, the test portion of the conduit completely enters the effective shooting area of ​​the camera.

[0011] In one possible implementation, the radiofrequency ablation device testing simulation device further includes a temperature control mechanism, the temperature control mechanism comprising: A heater is provided in the water tank; and A circulating pump, wherein the inlet and outlet of the circulating pump are respectively connected to the water tank.

[0012] In one possible implementation, the circulating pump is a peristaltic pump, with the inlet of the peristaltic pump located at the outlet side of the test model.

[0013] In one possible implementation, the bottom of the pool is provided with a plurality of positioning blocks spaced apart in a preset arrangement, the positioning blocks being wheel-shaped components with vertically arranged axes; the test model is a flexible tube, the flexible tube being wound around the corresponding positioning block along a preset path to form the test channel; the sidewall of the positioning block has a positioning groove for accommodating the flexible tube.

[0014] In one possible implementation, the bottom of the pool has a mounting hole, and the bottom of the positioning block has a screw that is threaded into the mounting hole.

[0015] Compared with the prior art, the advantages of the simulation device for testing radiofrequency ablation devices provided in this application are: The radiofrequency ablation device testing simulation device provided in this application includes a water tank, a test model, a clamping mechanism, and a driving mechanism. The test model is fixed in the water tank. The driving mechanism drives the catheter to reciprocate along the test channel formed by the test model through the clamping mechanism to perform bending fatigue testing. The test model includes a continuous first test segment and a second test segment with opposite bending directions. This application integrates two bending test segments with different directions into the same fixed physical model. During testing, the travel range of the reciprocating motion of the catheter test section can be changed by the driving mechanism, allowing the test section of the catheter to undergo bending fatigue testing successively in the first and second test segments. No manual intervention is required to rotate or reclamp the catheter throughout the process. This setup eliminates the need for manual operation, facilitating the automation of the testing process and enabling unattended, unmanned operation during long-term durability testing.

[0016] Secondly, this application provides a method for testing a radiofrequency ablation device, using the simulation device for testing a radiofrequency ablation device described in any of the above implementations, comprising the following steps: The test model is fixed in the water tank along a preset path, and physiological saline with a concentration of 0.9% is added to the water tank so that the physiological saline completely submerges the test model. The catheter of the radiofrequency ablation device to be tested is clamped onto the clamping mechanism, and the clamping mechanism is driven to move the catheter back and forth, and the first stage test and the second stage test are performed in sequence. During the first stage of testing, the drive mechanism drives the test section of the conduit to reciprocate between the beginning and end positions of the first test segment through the clamping mechanism, until a preset number of times are performed. During the second stage of testing, the drive mechanism drives the test section of the catheter to reciprocate between the beginning and end positions of the second test segment through the clamping mechanism, until a preset number of times.

[0017] In one possible implementation, during testing, an image of the duct's appearance is captured by a camera and the image is saved on a local storage medium or uploaded to the cloud.

[0018] The radiofrequency ablation device testing method provided in this application is implemented using the radiofrequency ablation device testing simulation device described in any of the above implementation methods, and has the same technical effect as it, so it will not be described again here. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 A schematic diagram of the bending fatigue testing device for a prior art radiofrequency ablation instrument; Figure 2 A perspective view of a simulation device for testing a radiofrequency ablation device provided in one embodiment of this application; Figure 3 A top view of a simulation device for testing a radiofrequency ablation device provided in one embodiment of this application; Figure 4 This is a schematic diagram of the positioning block in one embodiment of this application; Figure 5 A perspective view of a simulation device for testing a radiofrequency ablation device provided in another embodiment of this application; Figure 6 for Figure 5 Enlarged view of part A in the middle; Figure 7 This is a partial schematic diagram of the clamping mechanism in one embodiment of this application; Figure 8 This is a diagram showing the movement path of the catheter during the first phase of testing. Figure 9 This is a diagram showing the movement path of the catheter during the second phase of testing. Explanation of reference numerals in the attached figures: 10. Water tank; 11. Guide rail; 12. Positioning block; 121. Screw; 13. Mounting hole; 20. Test model; 21. First test section; 22. Second test section; 30. Clamping mechanism; 31. First mounting bracket; 32. Clamping block; 33. First driving component; 34. Conveyor wheel; 35. Second driving component; 40. Driving mechanism; 50. Shooting mechanism; 41. Shooting bracket; 42. Camera; 43. Third driving component; 60. Temperature control mechanism; 61. Heater; 62. Circulating pump. Detailed Implementation

[0021] To make the technical problems, technical solutions, and beneficial effects to be solved by this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and are not intended to limit the scope of this application.

[0022] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on or indirectly on that other component. When a component is referred to as being "connected to" another component, it can be directly connected to or indirectly connected to that other component.

[0023] It should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0024] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" or "several" means two or more, unless otherwise explicitly specified.

[0025] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0026] Figure 1 This is a schematic diagram of a prior art radiofrequency ablation device bending fatigue testing apparatus. It can be seen that the existing testing apparatus includes a test slot, a unidirectional bending model, and a clamp. After clamping, the clamp is manually moved back and forth to achieve the push-pull test of the catheter within the model. This testing apparatus and method require high manual skill, is prone to fatigue with numerous tests, and has a low degree of automation.

[0027] Please refer to the following: Figures 2 to 9 The following describes the simulation device and testing method for radiofrequency ablation instrument provided in the embodiments of this application.

[0028] In a first aspect, embodiments of this application provide a simulation device for testing a radiofrequency ablation device, including a water tank 10, a test model 20, a clamping mechanism 30, and a driving mechanism 40. The water tank 10 is used to hold 0.9% physiological saline; the test model 20 is disposed within the water tank 10, and the test model 20 has a hollow test channel with an inner diameter not greater than 5mm. The test channel has a first test segment 21 and a second test segment 22 arranged sequentially, both of which are arc segments with a bending angle of not less than 90 degrees, and the bending directions of the first test segment 21 and the second test segment 22 are opposite; the clamping mechanism 30 is disposed on the inlet side of the test model 20 and is used to clamp the catheter of the radiofrequency ablation device to be tested; the driving mechanism 40 is disposed above the water tank 10 and is used to drive the clamping mechanism 30 to reciprocate along the test direction.

[0029] Pool 10 is an open container, made of stainless steel, tempered glass, or other corrosion-resistant materials, used to hold an appropriate amount of 0.9% physiological saline test solution to simulate the internal environment of the human body. The overall shape of pool 10 is rectangular, and its internal space should be sufficient to accommodate the test model 20 and allow for the reciprocating movement of the catheter.

[0030] The test model 20 is fixedly installed inside the water tank 10 and can be secured using screws or other detachable methods. The main body of the test model 20 is a tube with a hollow inner cavity, which forms a test channel for simulating vascular pathways. The test channel consists of at least two sequentially connected curved sections, designated as the first test section 21 and the second test section 22. Each test section is an arc-shaped tube with a bending angle of not less than 90 degrees (e.g., 90°, 135°, 180°). The test model 20 can be made of fluorinated ethylene propylene or similar materials, and can be a flexible tube or a rigid tube (such as a glass tube). The inner wall is relatively smooth to ensure smooth sliding of the catheter. The material of the test model 20 is preferably transparent to facilitate observation of the catheter's movement path. The inner diameter of the test channel is designed to be no greater than 5 mm (e.g., it can be selected within the range of 2 mm to 5 mm, preferably 5 mm) to simulate the vascular environment within the human body.

[0031] like Figure 8 and Figure 9 As shown, the first test segment 21 and the second test segment 22 have opposite bending directions. For example, the first test segment 21 is curved in a clockwise direction, while the second test segment 22 is curved in a counterclockwise direction, thus forming an approximately "S" shaped path in space.

[0032] The clamping mechanism 30 is located on the outside of the inlet end (i.e., the catheter insertion end) of the test model 20, and is used to clamp the radiofrequency ablation device catheter to be tested. It can move as a whole under the drive mechanism 40. The clamping mechanism 30 can be a clamp or clamping robot that is already available on the market.

[0033] The drive mechanism 40 is mounted on the upper or side frame of the water tank 10 to provide power for linear reciprocating motion. Its output end is connected to the clamping mechanism 30, thereby driving the clamped conduit to reciprocate push-pull motion along its axial direction (i.e., the test direction, usually horizontal). The specific form of the drive mechanism 40 can be an electric linear module, a cylinder, a hydraulic cylinder, or a crank-slider mechanism, etc.

[0034] During testing, the catheter of the radiofrequency ablation device to be tested is clamped onto the clamping mechanism 30. The clamping mechanism 30 is driven to move the catheter back and forth, performing the first and second stage tests sequentially. Figure 8 As shown, during the first stage of testing, the clamping mechanism 30 drives the test portion of the catheter to reciprocate between the beginning and end positions of the first test section 21 until a preset number of reciprocations is reached. During the second stage of testing, the clamping mechanism 30 drives the test portion of the catheter to reciprocate between the beginning and end positions of the second test section 22 until a preset number of reciprocations is reached.

[0035] Compared with the prior art, the beneficial effects of the radiofrequency ablation device testing simulation device provided in this application embodiment are: The radiofrequency ablation device testing simulation device provided in this application includes a water tank 10, a test model 20, a clamping mechanism 30, and a driving mechanism 40. The test model 20 is fixed in the water tank 10. The driving mechanism 40 drives the catheter to reciprocate along the test channel formed by the test model 20 through the clamping mechanism 30 to perform bending fatigue testing. The test model 20 includes a first test segment 21 and a second test segment 22 that are continuous but have opposite bending directions. This application integrates two bending test segments with different directions into the same fixed physical model. During testing, the driving mechanism 40 only needs to change the travel range of the reciprocating motion of the catheter test section to allow the catheter test section to undergo bending fatigue testing successively in the first test segment 21 and the second test segment 22. No manual intervention is required to rotate or reclamp the catheter throughout the process. This setup eliminates the need for manual operation, helps to automate the testing process, and enables unattended, unmanned operation during long-term durability testing.

[0036] Please see Figure 6 and Figure 7 In some possible embodiments, the clamping mechanism 30 includes a first mounting frame 31, two clamping blocks 32, and a first driving member 33. The first mounting frame 31 is located on the entrance side of the test model 20, and the driving mechanism 40 is connected to the first mounting frame 31; the two clamping blocks 32 are disposed opposite to each other on the first mounting frame 31, and clamping grooves are respectively formed on the side of the two clamping blocks 32 adjacent to each other, forming a clamping space for accommodating the conduit between the two clamping grooves; the first driving member 33 is located on the first mounting frame 31 and is used to drive the two clamping blocks 32 to move closer or further apart from each other.

[0037] The first mounting bracket 31 is a rigid frame structure, fixedly connected to the motion output end (such as a slider, piston rod, etc.) of the drive mechanism 40 via connectors. Two clamping blocks 32 are positioned opposite each other on the first mounting bracket 31. Each clamping block 32 has a clamping groove on its side surface adjacent to the other. These two clamping grooves can be V-shaped grooves, arc-shaped grooves, or semi-circular grooves. When the two clamping blocks 32 are brought together, their clamping grooves together form a clamping space for accommodating and holding the catheter under test. The clamping blocks 32 should preferably be made of engineering plastic, nylon, or metal blocks with a rubber / silicone coating to prevent damage to the catheter's outer surface. The clamping force should be applied to ensure a stable clamping while minimizing damage to the catheter's outer surface.

[0038] The first driving element 33 is fixed on the first mounting bracket 31 and is used to provide driving force to make the two clamping blocks 32 move in opposite directions or in opposite directions. The first driving element 33 may be a two-way acting cylinder, a hydraulic cylinder, an electric push rod, or a mechanism in which a motor drives a lead screw and nut pair to drive the two clamping blocks 32 to move synchronously in opposite directions.

[0039] During the first and second phases of testing, the length of the catheter inserted into the test model 20 differs. When the clamping position remains constant, the clamping position of the clamping mechanism 30 should ensure that the test portion of the catheter can reach the target area. Figure 9 The second test segment 22 is shown. However, during the first stage of testing, due to the short length of the catheter inserted into the test model 20 and the long distance between the clamping position and the test model 20, the catheter may be bent or deformed, affecting the accuracy of the test.

[0040] To solve the above problems, the best way is to make the clamping position adjustable, that is, the clamping mechanism 30 is in different clamping positions during the first stage test and the second stage test, so that both clamping positions are close to the entrance side of the test model 20.

[0041] To achieve the above functionality, please refer to [link / reference]. Figure 6 and Figure 7Furthermore, the clamping mechanism 30 also includes a conveying wheel 34 and a second driving member 35. The two conveying wheels 34 are disposed opposite to each other on the first mounting frame 31. The conveying wheels 34 and the clamping block 32 are spaced apart along the axial direction of the conduit. The conveying wheels 34 and the first mounting frame 31 are rotatably engaged around a vertical axis, and a conveying space for accommodating the conduit is formed between the two conveying wheels 34. The second driving member 35 is disposed on the first mounting frame 31 and is used to drive the two conveying wheels 34 to rotate around their respective axes.

[0042] The second driving component 35 can be a motor, which drives the two conveying wheels 34 to rotate synchronously through common transmission methods such as gear transmission and chain transmission. The outer edge of the conveying wheel 34 is in contact with the conduit, and the friction force drives the conduit to move axially. It should be noted that when the conveying wheel 34 is running, the first driving component 33 controls the two clamping blocks 32 to be in the open state, releasing the conduit. After the conveying wheel 34 stops running, the first driving component 33 controls the two clamping blocks 32 to be in the clamping state, re-clamping and fixing the conduit.

[0043] The length of the catheter moved by the conveyor wheel 34 can be achieved through existing technologies such as counting the number of rotations of the conveyor wheel 34, capturing and identifying the movement position of the catheter by the camera 42, and setting multiple monitoring sensors at intervals along the extension direction on the outside of the test model 20. The monitoring sensors can be magnetic induction sensors, which can identify the position of the metal part at the head of the catheter and thus determine the insertion length of the catheter. The structure, installation, and usage of the above-mentioned technologies are all existing technologies and will not be described in detail here.

[0044] Please see Figure 2 In some possible embodiments, the water tank 10 is provided with a guide rail 11 along the test direction, and the drive mechanism 40 slides in cooperation with the guide rail 11; the radiofrequency ablation instrument testing simulation device also includes an imaging mechanism 50, which includes an imaging bracket 41, a camera 42, and a third drive member 43. The imaging bracket 41 is located above the water tank 10; the camera 42 is located on the imaging bracket 41 and above the inlet side of the test model 20, with the imaging end of the camera 42 facing downwards; the third drive member 43 is located in the water tank 10 and is used to drive the drive mechanism 40 to move along the guide rail 11.

[0045] During the test, for every preset number of reciprocating movements performed by the drive mechanism 40, the third drive component 43 performs one reciprocating movement. The movement speed of the third drive component 43 is less than that of the drive mechanism 40. During the reciprocating movement of the third drive component 43, the test part of the conduit completely enters the effective shooting area of ​​the camera 42.

[0046] In this embodiment, the guide rail 11 is mounted and fixed on the edge or upper support of the water tank 10 along the direction of the reciprocating motion of the conduit. The drive mechanism 40 forms a sliding engagement with the guide rail 11, enabling it to not only perform reciprocating push-pull actions but also slide along the guide rail 11 as a whole. The imaging mechanism 50 consists of an imaging bracket 41 and a camera 42. The imaging bracket 41 is fixed above the water tank 10. The camera 42 (such as an industrial CCD or CMOS camera 42) is mounted on the imaging bracket 41, with its lens (imaging end) facing vertically downwards, directly above the inlet area of ​​the test model 20, ensuring that its effective imaging area can cover the part of the conduit that may be exposed outside the test model 20.

[0047] The third drive unit 43 is mounted on the pool 10 or the base and is used to drive the entire drive mechanism 40 (together with the clamping mechanism 30 and the clamped conduit) to move slowly along the guide rail 11. The third drive unit 43 can be a combination of a linear motor, an electric slide, or a lead screw stepper motor.

[0048] In this embodiment, the working logic of the imaging mechanism 50 is as follows: During the test, the drive mechanism 40 performs reciprocating push-pull motion of the catheter within the model at a relatively fast speed, such as once every 1-2 seconds. After completing a preset number of reciprocations (such as ten or twenty times), the third drive component 43 is activated, driving the entire drive mechanism 40 and the catheter to slowly move one stroke along the guide rail 11 (so that the test part of the catheter that may be fatigued is completely moved into the field of view of the camera 42). During this slow movement, the camera 42 performs continuous or fixed-point shooting to record the surface state of the catheter. Subsequently, the third drive component 43 moves back to its original position. The movement speed of the third drive component 43 is much lower than the reciprocating speed of the drive mechanism 40. This ensures clear images and avoids water ripples on the saline surface caused by excessively fast movement, which would affect the shooting effect.

[0049] There are no specific restrictions on the operating speeds of the drive mechanism 40 and the third drive component 43. Users can choose the appropriate speed according to their actual needs to achieve the desired purpose. For example, the moving speed of the drive mechanism 40 can be 1 m / s, and the moving speed of the third drive component 43 can be 0.1 m / s.

[0050] Please see Figure 2 , Figure 3 and Figure 5 In some possible embodiments, the simulation device for testing radiofrequency ablation instruments further includes a temperature control mechanism 60, which includes a heater 61 and a circulation pump 62. The heater 61 is disposed in the water tank 10; the inlet and outlet of the circulation pump 62 are respectively connected to the water tank 10.

[0051] Heater 61 is placed in the physiological saline in pool 10 to heat and maintain the saline at a constant temperature, such as 37±0.5℃ (simulating human body temperature). Heater 61 can be an immersion electric heating rod, heating coil, etc., and is usually equipped with a temperature sensor (such as PT100).

[0052] The inlet and outlet of the circulation pump 62 are connected to different areas of the water tank 10 via pipes to promote the circulation of physiological saline in the water tank 10, thereby ensuring uniform water temperature and simulating the blood flow environment in the body. The circulation pump 62 can be a centrifugal pump, magnetic pump, etc.

[0053] In one specific embodiment, the circulation pump 62 is a peristaltic pump. The inlet of the peristaltic pump is located on the outlet side of the test model 20, and can be directly connected to the test model 20 or located near the outlet of the test model 20. The purpose is to generate a fluid flow similar to the blood flow inside a vein within the test model 20, thereby improving the realism of the simulation.

[0054] Please refer to 2 to Figure 5 In some possible embodiments, the bottom of the pool 10 is provided with a plurality of positioning blocks 12 at intervals along a preset arrangement. The positioning blocks 12 are wheel-shaped components with their axes set vertically. The test model 20 is a flexible tube, which is wound around the corresponding positioning block 12 along a preset path to form a test channel. The side wall of the positioning block 12 has a positioning groove for accommodating the flexible tube.

[0055] The bottom of the pool 10 has multiple mounting holes 13 arranged in a preset pattern. Positioning blocks 12 are correspondingly mounted on each mounting hole 13, and the bottom of each positioning block 12 has a screw 121 that threadedly engages with the mounting hole 13. The mounting holes 13 can be arranged in a rectangular or other pattern, allowing the flexible tube to be wound around different positioning frames. This changes the shape of the test channel by altering the path of the flexible tube. The height of the positioning blocks 12 can be adjusted using the screws, raising part of the flexible tube. This allows the test channel to bend not only horizontally but also vertically in the horizontal plane, providing a wider range of possible angles.

[0056] In this embodiment, the flexible tube is sequentially wound around or through the positioning grooves on the corresponding positioning block 12 according to a preset bending path, so that a test channel with a specific bending shape and direction (including the first test segment 21 and the second test segment 22) can be easily formed in three-dimensional space. By changing the position of the positioning block 12 or the winding method of the flexible tube, different test models 20 can be quickly reconstructed to more realistically simulate the blood vessel path in the human body.

[0057] Secondly, embodiments of this application provide a method for testing a radiofrequency ablation device, using a simulation device for testing a radiofrequency ablation device provided in any of the above embodiments, including the following steps: The test model 20 is fixed in the water tank 10 along the preset path. A 0.9% physiological saline solution is added to the water tank 10 so that the physiological saline solution completely submerges the test model 20 and ensures that there are no air bubbles inside the test channel. The temperature control mechanism 60 is turned on to heat the physiological saline solution and stabilize it at 37±0.5℃.

[0058] The catheter of the radiofrequency ablation device to be tested is clamped onto the clamping mechanism 30, and the clamping mechanism 30 is driven to move the catheter back and forth, and the first stage test and the second stage test are performed in sequence.

[0059] like Figure 8 As shown, during the first stage of testing, the clamping mechanism 30 drives the test section of the conduit to reciprocate between the beginning (point a) and the end (point b) of the first test segment 21 until the preset number of reciprocations is reached; Figure 9 As shown, when the second stage test is performed, the clamping mechanism 30 drives the test part of the conduit to move back and forth between the beginning (point b) and the end (point c) of the second test section 22 until the preset number of times.

[0060] During the test, after each preset number of tests (e.g., 15 times), the third drive component 43 performs a reciprocating movement once, capturing an image of the duct's appearance via camera 42, and saving the image to local storage or uploading it to the cloud. These images are used for subsequent inspection of the duct to check for defects such as surface roughness, cracks, and coating peeling during the fatigue test.

[0061] The captured images can be transmitted in real time via the network to the tester's receiving terminal (such as a mobile phone or computer), allowing the tester to analyze and judge the test results by viewing the images. In addition to setting up camera 42 at the top, camera 40 can also be set up to the side or at an angle above for shooting from different angles.

[0062] The radiofrequency ablation instrument testing simulation device provided in this application embodiment has multiple moving / actuating components during operation, such as a circulating pump 62, a cylinder, a motor, a sensor, a controller, etc. The operation of the above-mentioned electronic devices can be automatically controlled by the controller or manually operated by the control panel.

[0063] It should be noted that the core innovation of this application lies in the innovative mechanical structure, spatial layout, and interconnection and coordination of the aforementioned physical components. The aim is to solve the problem mentioned in the background art where "operators need to manually perform the reversal and re-clamping of the conduit, which is inconvenient" through structural integration and optimization. The specific controller and control scheme used to coordinate the operation of these components are common existing technologies in the field of automation control. Based on the mechanical structure, functional description of the actuators, and testing procedures disclosed in this application, those skilled in the art can select and configure appropriate controllers and sensors according to actual needs. Therefore, even if this application does not describe the specific model, circuit diagram, or control code of the controller in detail, it will not prevent the technical solution from being understood and implemented, and its integrity remains unaffected. The core contribution of this application is to provide a novel mechanical structure device and its testing method to solve specific operational inconvenience problems.

[0064] It is understood that the parts in the above embodiments can be freely combined or deleted to form different combined embodiments. The specific contents of each combined embodiment will not be repeated here. After this description, it can be considered that the present invention specification has recorded each combined embodiment and can support different combined embodiments.

[0065] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A simulation device for testing radiofrequency ablation instruments, characterized in that, include: Pool (10) is used to hold physiological saline. The test model (20) is set in the water tank (10). The test model (20) has a hollow test channel. The test channel has a first test section (21) and a second test section (22) arranged in sequence. The first test section (21) and the second test section (22) are both arc segments with a bending angle of not less than 90 degrees. The bending directions of the first test section (21) and the second test section (22) are opposite. A clamping mechanism (30), located at the inlet side of the test model (20), is used to clamp the catheter of the radiofrequency ablation device to be tested; and A drive mechanism (40) is located above the water tank (10) and is used to drive the clamping mechanism (30) to reciprocate along the test direction.

2. The simulation device for testing radiofrequency ablation devices according to claim 1, characterized in that, The clamping mechanism (30) includes: The first mounting bracket (31) is located on the entrance side of the test model (20), and the drive mechanism (40) is connected to the first mounting bracket (31); Two clamping blocks (32) are disposed opposite to each other on the first mounting bracket (31). Clamping grooves are respectively formed on the sides of the two clamping blocks (32) adjacent to each other, and a clamping space for accommodating the conduit is formed between the two clamping grooves; and A first drive element (33), disposed on the first mounting bracket (31), is used to drive the two clamping blocks (32) to move closer or further apart from each other.

3. The simulation device for testing radiofrequency ablation devices according to claim 2, characterized in that, The clamping mechanism (30) further includes: Two conveying wheels (34) are disposed opposite to each other on the first mounting frame (31). The conveying wheels (34) and the clamping block (32) are spaced apart along the axial direction of the conduit. The conveying wheels (34) and the first mounting frame (31) rotate around a vertical axis, and a conveying space for accommodating the conduit is formed between the two conveying wheels (34). The second drive element (35), located on the first mounting bracket (31), is used to drive the two conveying wheels (34) to rotate about their respective axes.

4. The simulation device for testing radiofrequency ablation devices according to claim 1, characterized in that, The water tank (10) is provided with a guide rail (11) along the test direction, and the drive mechanism (40) slides in cooperation with the guide rail (11); the radiofrequency ablation instrument test simulation device also includes an imaging mechanism (50), which includes: A shooting bracket (41) is positioned above the pool (10); and A camera (42) is mounted on the shooting bracket (41) and positioned above the entrance side of the test model (20), with the shooting end of the camera (42) facing downwards; and The third driving component (43) is provided in the water tank (10) and is used to drive the driving mechanism (40) to move along the guide rail (11); During the test, the third drive (43) performs a reciprocating movement once for every preset number of reciprocating movements performed by the drive mechanism (40). The movement speed of the third drive (43) is less than that of the drive mechanism (40). During the reciprocating movement of the third drive (43), the test part of the conduit is completely inside the effective shooting area of ​​the camera (42).

5. The simulation device for testing radiofrequency ablation devices according to claim 1, characterized in that, The radiofrequency ablation instrument testing simulation device further includes a temperature control mechanism (60), which includes: A heater (61) is provided in the water tank (10); and A circulation pump (62) is connected to the water tank (10) at its inlet and outlet ends.

6. The simulation device for testing radiofrequency ablation devices according to claim 5, characterized in that, The circulating pump (62) is a peristaltic pump, and the inlet of the peristaltic pump is located on the outlet side of the test model (20).

7. The simulation device for testing radiofrequency ablation devices according to claim 1, characterized in that, The bottom of the pool (10) is provided with a plurality of positioning blocks (12) arranged at intervals along a preset pattern. The positioning blocks (12) are wheel-shaped components with their axes set vertically. The test model (20) is a flexible tube, which is wound around the corresponding positioning block (12) along a preset path to form the test channel. The side wall of the positioning block (12) has a positioning groove for accommodating the flexible tube.

8. The simulation device for testing radiofrequency ablation devices according to claim 7, characterized in that, The bottom of the pool (10) is provided with an installation hole (13), and the bottom of the positioning block (12) has a screw (121) that is threaded into the installation hole (13).

9. A testing method for a radiofrequency ablation device, characterized in that, The simulation device for testing radiofrequency ablation devices according to any one of claims 1 to 8 includes the following steps: The test model (20) is fixed in the water tank (10) along a preset path, and physiological saline with a concentration of 0.9% is added to the water tank (10) so that the physiological saline completely submerges the test model (20). The catheter of the radiofrequency ablation device to be tested is clamped onto the clamping mechanism (30), and the clamping mechanism (30) is driven to move the catheter back and forth, and the first stage test and the second stage test are carried out in sequence. When the first stage test is performed, the drive mechanism (40) drives the test part of the conduit to move back and forth between the beginning and end positions of the first test segment (21) through the clamping mechanism (30) until the preset number of times; When the second stage test is performed, the drive mechanism (40) drives the test part of the conduit to move back and forth between the beginning and end positions of the second test section (22) through the clamping mechanism (30) until the preset number of times.

10. The radiofrequency ablation device testing method according to claim 9, characterized in that, During the test, the appearance of the catheter is captured by a camera (42), and the image is saved on a local storage medium or uploaded to the cloud.

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