CN113375880B - Micro-catheter axial rigidity detection device and axial rigidity evaluation method - Google Patents

Micro-catheter axial rigidity detection device and axial rigidity evaluation method Download PDF

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Publication number
CN113375880B
CN113375880B CN202110607430.XA CN202110607430A CN113375880B CN 113375880 B CN113375880 B CN 113375880B CN 202110607430 A CN202110607430 A CN 202110607430A CN 113375880 B CN113375880 B CN 113375880B
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sliding block
catheter
movable
fixed
micro
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CN113375880A (en
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纪静
黄健
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Taizhou Jianlang Medical Devices Co ltd
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Taizhou Jianlang Medical Devices Co ltd
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01MTESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M5/00Investigating the elasticity of structures, e.g. deflection of bridges or air-craft wings
    • G01M5/0041Investigating the elasticity of structures, e.g. deflection of bridges or air-craft wings by determining deflection or stress
    • G01M5/005Investigating the elasticity of structures, e.g. deflection of bridges or air-craft wings by determining deflection or stress by means of external apparatus, e.g. test benches or portable test systems
    • G01M5/0058Investigating the elasticity of structures, e.g. deflection of bridges or air-craft wings by determining deflection or stress by means of external apparatus, e.g. test benches or portable test systems of elongated objects, e.g. pipes, masts, towers or railways
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01MTESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M5/00Investigating the elasticity of structures, e.g. deflection of bridges or air-craft wings
    • G01M5/0066Investigating the elasticity of structures, e.g. deflection of bridges or air-craft wings by exciting or detecting vibration or acceleration

Abstract

The invention discloses a device for detecting the axial rigidity of a micro-catheter, which is provided with a test platform and: a horizontal slide rail; a polygonal positioning hole for placing the tested micro catheter is formed in one side of the fixed sliding block, which faces the movable sliding block, and a scale is arranged between the movable sliding block and the fixed sliding block; the movable sliding block is connected to the horizontal sliding rail and slides, the movable sliding block is driven to slide by the power loading device, and a movable test hole position is arranged at the position corresponding to the polygonal positioning hole; a force sensor is fixed on an output shaft of the power loading device; and the control device is used for acquiring and displaying the stress data F of the micro catheter to be tested, and a counter is arranged in the control device, so that the sliding time of the micro catheter to be tested and the moving speed of the power loading device are acquired to obtain the deformation displacement of the micro catheter. According to the axial stiffness detection device and the evaluation method, the axial stiffness of the microcatheter is detected in advance during product design and development, so that the intravascular microcatheter with better axial stiffness is produced, and evaluation is established, so that the safety of the microcatheter during placement is ensured.

Description

Micro-catheter axial rigidity detection device and axial rigidity evaluation method
Technical Field
The invention relates to the technical field of the structure and strength of a micro-catheter, in particular to a micro-catheter axial rigidity detection device and an axial rigidity evaluation method.
Background
Interventional therapy is a minimally invasive treatment using modern high-tech means. Under the guidance of medical imaging equipment, special precise medical instruments such as catheters, guide wires and the like are introduced into a human body to diagnose and locally treat internal pathological conditions.
Percutaneous Transluminal Angioplasty (PTA) is a vascular stenosis or occlusive lesion caused by atherosclerosis or other reasons after dilation with a catheter or other devices. This therapy was started in the 60 s and mainly applied to limb vessels, and gradually expanded to internal arteries such as renal arteries and coronary arteries in the 80 s, and developed from arteries to veins, such as dilatation to treat stenosis of vena cava, and further to treat stenosis or occlusion of artificial blood vessels and transplanted blood vessels.
Microcatheters, guide catheters, contrast catheters, and the like are common percutaneous transluminal angioplasty devices. Such intravascular catheters are typically of a three-layer construction including an inner teflon lubricious coating, a middle metal braided reinforcement layer, and an outermost outer sheath. The sheath is typically made of a series of block polyamides of varying hardness, decreasing in hardness from the operating end to the patient. The clinical use of such intravascular catheters is generally as follows: (1) a sedinger operation is adopted to firstly establish a percutaneous access path of an intravascular device; (2) placing a guide wire through the sheath; (3) after the guide wire is positioned at a preset position, the intravascular catheter is placed along the guide wire, and subsequent treatment is carried out.
Axial stiffness of the catheter is an important property during catheter placement, which refers to the ability of the catheter to resist axial bending during placement along the guidewire into the body. The axial rigidity of the catheter is low, and the catheter is easy to bend axially in the process of placement, so that the catheter fails, the catheter needs to be replaced, and economic loss and even delay of treatment are caused to patients.
Disclosure of Invention
In order to overcome the defects of the prior art, the invention provides the microcatheter axial rigidity testing system which can measure the critical axial bending force of the microcatheter, evaluate the axial rigidity of the microcatheter, produce the intravascular catheter with axial bending resistance and quickly and efficiently detect the axial rigidity of the microcatheter.
The technical scheme adopted by the invention is as follows: little pipe axial rigidity detection device has test platform, detection device still includes:
the horizontal sliding rail is fixed on the test platform and is connected with the fixed sliding block and the movable sliding block;
the fixed sliding block is fixed on the horizontal sliding rail, one side of the fixed sliding block, which faces the movable sliding block, is provided with a polygonal positioning hole for placing the micro-catheter to be tested, and a scale is arranged between the movable sliding block and the fixed sliding block;
the movable sliding block is connected to the horizontal sliding rail to slide, is driven by the power loading device to slide on the horizontal sliding rail in a direction close to or far away from the fixed sliding block, and is also provided with a movable test hole position corresponding to the position of the polygonal positioning hole for the other end of the tested micro catheter to be inserted and positioned;
The output shaft of the power loading device is fixedly provided with a force sensor which is used for detecting the force F applied to the tested micro-catheter between the movable sliding block and the fixed sliding block; the electric connection control device;
the control device acquires and displays stress data F of the micro-catheter to be tested, a counter is arranged in the control device, and the sliding time of the micro-catheter to be tested and the moving speed of the power loading device are acquired to obtain the deformation displacement of the micro-catheter;
the scale ruler is fixedly connected to the movable sliding block, and the zero point is arranged on one side close to the movable sliding block.
Preferably, the dynamic test position is a blind hole which is coaxial with the polygonal positioning hole along the long axis direction and is arranged on one side close to the fixed sliding block.
Preferably, one side of the movable sliding block, which is close to the power loading device, is provided with a movable connecting hole to be connected with the output shaft, and a fixed connecting hole is arranged in a direction perpendicular to the movable connecting hole and is used for being in through connection with a shaft connecting through hole of the output shaft through a fixed part of the movable sliding block.
Preferably, the fixed sliding block is provided with a fixed sliding block fixed connection hole in the vertical direction, and the fixed sliding block fixing piece penetrates through the fixed sliding block fixed connection hole and the horizontal sliding rail to be fixedly connected.
Preferably, the bottom of the fixed connecting hole of the fixed sliding block is of a conical structure.
Preferably, the control device is further connected with a display device for displaying the detected force data F of the tested micro-catheter and inputting and displaying the axial displacement of the tested micro-catheter under a plurality of force states.
Preferably, the test platform is supported and placed by a test support.
Preferably, the control device has:
the acceleration key module is used for increasing the loading speed of the power loading device;
the speed reduction key module is used for reducing the loading speed of the power loading device;
and the zero-returning button module is used for zero-returning the data in the control device.
Preferably, the power loading device is also driven by the power slide block to slide on the horizontal slide rail.
The method for evaluating the axial rigidity of the microcatheter uses the device for detecting the axial rigidity of the microcatheter as claimed in the claim to evaluate, and the specific evaluation steps at least comprise:
s1: placing the micro-catheter to be tested in the polygonal positioning hole of the fixed sliding block, starting the control device at the same time, and pressing the zero returning button module;
s2: adjusting the movable sliding block until the tested micro-catheter in the step S1 is inserted into the movable testing hole of the movable sliding block and the tested micro-catheter can not slide any more;
s3: in the process of loading force by the power loading device, the acceleration key module is adjusted to accelerate the moving speed of the movable slide block; the deceleration key module decelerates the moving speed of the movable slide block;
S4: when the movable sliding block is at a certain distance from the zero point, the start-stop button is pressed down, and the movement of the movable sliding block is stopped in time;
s5: observing the displacement and stress relation of the movable sliding block, wherein the axial force borne by the movable sliding block is gradually increased along with the increase of the displacement and reaches a peak value at a certain displacement; at the moment, the movable sliding block further moves, when the stress is suddenly reduced by more than 0.2N compared with the peak value, the sliding block displacement of the force reduction point is recorded, namely Euler bending displacement, and the Euler bending displacement is not less than 25mm, the axial rigidity of the tested micro-catheter is judged to meet the puncture requirement of the operation, and the micro-catheter meeting the requirement is not easy to break in the process of implantation.
Compared with the prior art, the invention has the beneficial effects that:
the axial rigidity detection device and the evaluation method for the microcatheter are designed and established in order to evaluate the axial rigidity of the microcatheter during the product design and development period and produce the intravascular microcatheter with better axial rigidity, and the axial rigidity of the produced microcatheter is tested in advance to ensure the safety of catheter implantation and more smoothly finish the operation.
The testing device has the advantages of high automation degree, low manufacturing cost, simple and convenient operation and quick and accurate detection result.
Drawings
FIG. 1 is a front view of a microcatheter axial stiffness sensing device;
FIG. 2 is a schematic structural diagram of one embodiment of a control device;
FIG. 3 is a connection structure diagram of the movable slide block and the power loading device;
FIG. 4 is a block diagram of one embodiment of a graduated scale 90;
fig. 5 is a connection structure diagram of the fixed slider 80 mounted on the horizontal slide rail 70;
FIG. 6 is an isometric view of the embodiment of FIG. 1;
wherein: 10-a test support, 20-a test platform, 30-a control device, 31-a ship-shaped switch, 32-a start-stop button, 33-an acceleration key module A, 34-an acceleration key module B, 35-a deceleration key module A, 36-a deceleration key module B, 37-a zero-return button module; 40-a display device, 50-a power loading device, 51-an output shaft, 52-a shaft connecting through hole, 53-a force sensor and 54-; 60-a display device, 61-a dynamic test hole position, 62-a dynamic connecting hole, 63-a dynamic sliding block fixing part and 64-a dynamic sliding block fixing part; 70-horizontal sliding rail, 80-fixed sliding block, 81-polygonal positioning hole, 82-fixed sliding block fixing connecting hole and 83-fixed sliding block fixing piece; 90-scale ruler, 100-power slide block and 110-micro conduit to be tested.
Detailed Description
Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the accompanying drawings are illustrative only for the purpose of explaining the present invention and are not to be construed as limiting the present invention.
In the description of the present invention, it is to be understood that the terms "center", "upper", "lower", "front", "rear", "left", "right", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the combination or element referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, are not to be construed as limiting the present invention. In addition, in the description process of the embodiment of the present invention, the positional relationships of the devices such as "upper", "lower", "front", "rear", "left", "right", and the like in all the drawings are based on fig. 1.
As shown in fig. 1 and 6, the microcatheter axial stiffness detection device includes a test platform 20, and the detection device further includes:
the horizontal sliding rail 70 is fixed on the test platform 20, is connected with the fixed sliding block 80 and the movable sliding block 60, and can be made of self-lubricating Teflon material with good wear resistance;
the fixed sliding block 80 is fixed on the horizontal sliding rail 70, one side facing the movable sliding block 60 is provided with a polygonal positioning hole 81 for placing the micro-catheter to be tested, and a scale 90 is arranged between the movable sliding block 60 and the fixed sliding block 80; the fixed sliding block 80 can be made of stainless steel material and used for simulating the axial stress of the tested micro-catheter, and the polygonal positioning hole 81 can be designed to be a coaxial blind hole with the radius of 3mm and the depth of 50mm along the long axis direction.
The movable sliding block 60 is connected to the horizontal sliding rail 70 to slide, and is driven by the power loading device 50 to slide on the horizontal sliding rail 70 in a direction close to or far away from the fixed sliding block 80; with reference to fig. 3 and 5, the movable slider 60 is further provided with a movable testing hole 61 corresponding to the polygonal positioning hole 81 for inserting and positioning the other end of the micro-catheter to be tested, so that the design has the advantage that both ends of the micro-catheter to be tested can be fixed to keep a better stress point;
as shown in fig. 1, the force sensor 53 is fixed on the output shaft 51 of the power loading device 50, and is used for detecting the stressed data F applied to the tested micro-catheter 110 between the movable slider 60 and the fixed slider 70, the range of the force sensor is usually selected to be not less than 5N, and the precision is not more than 0.005N; an electric connection control device 30;
the control device 30 acquires and displays the stress data F of the tested micro-catheter 110, a counter is arranged in the control device, and the deformation displacement of the micro-catheter can be directly calculated through the sliding time of the movable sliding block and the speed of the power loading device 50;
in combination with fig. 1 and 4, the graduated scale 90 is fixedly connected to the movable slider 60, and a zero point is disposed at a side close to the movable slider 60, so as to visually observe the length deformation displacement of the microcatheter when the axial stiffness of the microcatheter is measured.
As seen in FIG. 3, the dynamic test site 61 is a blind hole coaxial with the polygonal positioning hole 81 along the long axis direction and is disposed at a side close to the fixed slider 80, and the dynamic test site 61 is a coaxial blind hole with a radius of 3mm and a depth of 50mm in the preferred embodiment, so that the positioning and the force application can be better realized. In practice, the traveling block 60 may be made of stainless steel material to apply an axial force to the catheter. The dynamic testing position 61 can be a coaxial blind hole with the radius of 3mm and the depth of 50mm along the long axis direction, and is positioned at one side close to the fixed sliding block 80.
The movable connecting position 62 is a circular blind hole which is horizontal and coaxial with the movable testing position 61, and the inner diameter of the movable connecting position 62 is the same as the outer diameter of the connecting shaft 51.
As also shown in fig. 3, the movable slider 60 is provided with a movable connecting hole 62 near one side of the power loading device 50 to connect with the output shaft 51; the fixed connecting hole 63 is arranged in the direction perpendicular to the movable connecting hole 62, the fixed connecting hole 63 is used for supplying the movable sliding block fixing piece 64 and the shaft connecting through hole 52 of the output shaft 51 for penetrating connection, so that the movable sliding block 60 and the output shaft of the power loading device 50 are fixedly connected, the connecting structure is simple and feasible, and the configuration is reasonable and convenient. The movable sliding block 60 is connected with the power loading device 50 according to the scheme, and is driven by the power loading device 50 to do uniform reciprocating motion along the horizontal track direction at a set speed. The power loading device 50 may be one of a cylinder, an oil cylinder, a motor and the like.
In fig. 5, the fixed block 80 of the microcatheter axial stiffness detecting device is vertically provided with a fixed block fixing connection hole 82, and a fixed block fixing member 83 penetrates through the fixed block fixing member to be fixedly connected with the horizontal slide rail 70, so as to be fixedly connected to the horizontal slide rail, and a cross section of the fixed block fixing connection hole 82 can be set to be a polygonal structure, such as a triangle, a quadrangle, a pentagon, a hexagon, and the like.
The bottom of the fixed sliding block fixing connecting hole 82 is of a conical structure, so that the fixing strength of the fixed sliding block fixing connecting hole is improved.
The control device 30 is further connected to the display device 40 for displaying the detected force data F of the microcatheter under test 110 and for inputting and displaying the axial displacement of the microcatheter under test 110 under several force conditions, so as to facilitate recording and analyzing each force condition of the microcatheter under test, and to provide for sufficient preparation for evaluating the microcatheter under test.
The test platform 20 is supported and placed by the test support 10, so that the whole device can be used independently without limitation.
As shown in fig. 2, the control device 30 includes:
the acceleration key module is used for increasing the loading speed of the power loading device 50, and in the specific implementation process, the acceleration key module a33 and the acceleration key module B with different accelerations can be arranged, or only one acceleration key module can be arranged, but two or more acceleration key modules can be arranged with different accelerations, so that the control and adjustment use are convenient, and the arrangement principle and the method of the deceleration key module are the same as those of the acceleration key module;
The deceleration key module can be set as a plurality of deceleration key modules A35 and B36 with different deceleration speeds in the specific implementation process, and is used for reducing the loading speed of the power loading device 50, or only one deceleration key module can be set, and the deceleration key module is selected according to the detection condition;
a zero-back button module 37 for clearing data within the control device 30, including but not limited to data displayed by the display device and force sensor data;
the modules are used for controlling the power loading device 50 to drive the movable sliding block 60 to perform pressure adjustment control on the micro-catheter to be tested, and specifically can realize gradual pressurization, pressure reduction and zero clearing pressure on the micro-catheter to be tested, and in addition, the control device 30 also has a ship-shaped switch 31 and a start-stop button 32 in a specific implementation process, and is used for realizing power control and start-stop state control on the control device.
The power loading device 50 is also driven by the power slider 100 to slide on the horizontal slide rail 70, so that the micro-catheters with different lengths can be tested, and the application range is wider.
The method for evaluating the axial rigidity of the microcatheter uses the device for detecting the axial rigidity of the microcatheter to evaluate, and comprises the following specific evaluation steps:
S1: placing the micro-catheter to be tested in the polygonal positioning hole 81 of the fixed sliding block 80, starting the control device 30 at the same time, and pressing the zero returning button module 37;
s2: adjusting the movable sliding block 60 until the tested micro-catheter in the step S1 is inserted into the movable testing hole 61 of the movable sliding block 60 and the tested micro-catheter can not slide any more;
s3: in the process of loading force by the power loading device 50, the acceleration key modules 33 and 34 are adjusted to accelerate the moving speed of the movable slide block; the deceleration key modules 35 and 36 are used for decelerating the moving speed of the movable slide block;
s4: when the movable sliding block 60 is at a certain distance from the zero point, the start-stop button 32 is pressed down to stop the movement of the movable sliding block in time;
s5: observing the displacement and stress relation of the movable sliding block 60, wherein the axial force borne by the movable sliding block 60 is gradually increased along with the increase of the displacement and reaches a peak value at a certain displacement; at this time, the movable slider 60 moves further, when the stress is suddenly reduced by more than 0.2N compared with the peak value, the slider displacement of the force reduction point is recorded, namely the Euler bending displacement, and the Euler bending displacement is not less than 25mm, and the axial rigidity of the tested micro-catheter is judged to meet the puncture requirement of the operation.
In the implementation of the above evaluation method, the microcatheter to be tested is generally selected by cutting a tube body about 170mm from the proximal end of the microcatheter as a sample and lightly inserting the sample into the positioning test position 81, and the speeds of the acceleration key module and the deceleration key module can be set to be 1mm/s to 5mm/s, and can be set to be 0.1 mm/s to 0.5 mm/s.
The embodiments of the present invention are disclosed as the preferred embodiments, but not limited thereto, and those skilled in the art can easily understand the spirit of the present invention and make various extensions and changes without departing from the spirit of the present invention.

Claims (10)

1. Little pipe axial rigidity detection device, including test platform (20), its characterized in that: the detection device further comprises:
the horizontal sliding rail (70) is fixed on the test platform (20) and is connected with the fixed sliding block (80) and the movable sliding block (60);
the fixed sliding block (80) is fixed on the horizontal sliding rail (70), one side facing the movable sliding block (60) is provided with a polygonal positioning hole (81) for placing the tested micro-catheter, and a scale (90) is arranged between the movable sliding block (60) and the fixed sliding block (80);
the movable sliding block (60) is connected to the horizontal sliding rail (70) to slide, and is driven by the power loading device (50) to slide on the horizontal sliding rail (70) in the direction close to or far away from the fixed sliding block (80), and a movable test hole position (61) is arranged at the position corresponding to the polygonal positioning hole (81) and used for inserting and positioning the other end of the micro-catheter to be tested;
The power loading device (50) is characterized in that a force sensor (53) is fixed on an output shaft (51) of the power loading device (50) and used for detecting stress data F borne by a tested micro-catheter (110) applied between a movable sliding block (60) and a fixed sliding block (70); an electrical connection control device (30);
the control device (30) acquires and displays stress data F of the tested micro-catheter (110), a counter is arranged in the control device, and the sliding time of the tested micro-catheter and the moving speed of the power loading device (50) are acquired to obtain the deformation displacement of the micro-catheter;
the scale (90) is fixedly connected to the movable sliding block (60), and the zero point is arranged on one side close to the movable sliding block (60).
2. The axial stiffness detecting device according to claim 1, wherein: the dynamic test hole position (61) is a blind hole which is coaxial with the polygonal positioning hole (81) along the long axis direction and is arranged at one side close to the fixed sliding block (80).
3. The axial stiffness detecting device according to claim 2, wherein:
one side of the movable sliding block (60), which is close to the power loading device (50), is provided with a movable connecting hole (62) to be connected with the output shaft (51), and a fixed connecting hole (63) is arranged in a direction vertical to the movable connecting hole (62);
And the fixed connecting hole (63) is used for supplying the shaft connecting through hole (52) of the movable sliding block fixing piece (64) and the output shaft (51) to be connected in a penetrating way.
4. The axial rigidity detection device according to claim 1, characterized in that:
the fixed sliding block (80) is provided with a fixed sliding block fixed connecting hole (82) in the vertical direction, and a fixed sliding block fixing piece (83) penetrates through the fixed sliding block fixed connecting hole and is fixedly connected with the horizontal sliding rail (70).
5. The axial rigidity detection device according to claim 4, wherein:
the bottom of the fixed connecting hole (82) of the fixed sliding block is of a conical structure.
6. The axial rigidity detection device according to claim 1, characterized in that:
the control device (30) is also connected with a display device (40) and is used for displaying the detected stress data F of the tested micro-catheter (110) and inputting and displaying the axial displacement of the tested micro-catheter (110) under a plurality of stress states.
7. The axial rigidity detection device according to claim 1, characterized in that:
the test platform (20) is supported and placed through the test support (10).
8. The axial stiffness detecting device according to any one of claims 1 to 7, wherein:
The control device (30) comprises:
an acceleration key module for increasing a loading speed of the power loading device (50);
a deceleration key module for reducing a loading speed of the power loading device (50);
and a zero-return button module (37) for clearing data in the control device (30).
9. The axial stiffness detecting device according to any one of claims 1 to 7, wherein:
the power loading device (50) is also driven to slide on the horizontal sliding rail (70) through the power sliding block (100).
10. The method for evaluating the axial rigidity of the microcatheter is characterized by comprising the following steps: the microcatheter axial stiffness test device of claim 9 is used for evaluation, and the specific evaluation steps at least comprise:
s1: placing the micro-catheter to be tested in a polygonal positioning hole (81) of a fixed sliding block (80), starting a control device (30) at the same time, and pressing a zero returning button module (37);
s2: adjusting the movable sliding block (60) until the tested micro-catheter in the step S1 is inserted into the movable testing hole (61) of the movable sliding block (60) and the tested micro-catheter can not slide any more;
s3: in the process of loading force by a power loading device (50), adjusting the moving speed of an acceleration key module for accelerating a movable slide block; the speed reduction key module reduces the moving speed of the movable sliding block;
S4: when the movable sliding block (60) is away from the zero point by a certain distance, the start-stop button (32) is pressed down, and the movement of the movable sliding block is stopped in time;
s5: and observing the displacement and stress relation of the movable sliding block (60):
the axial force borne by the movable sliding block (60) is gradually increased along with the increase of the displacement and reaches a peak value at a certain displacement; at the moment, the movable sliding block (60) moves further, when the stress is suddenly reduced by more than 0.2N compared with the peak value, the sliding block displacement of the force reduction point is recorded, namely Euler bending displacement, and the Euler bending displacement is not less than 25mm, so that the axial rigidity of the tested micro-catheter can be judged to meet the puncture requirement of the operation.
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