Full-process performance detection method and device for slender puncture needle

Abstract

The invention provides a full-process performance detection method and device for a slender puncture needle. The full-process performance detection method comprises the following steps: (1) pretreatment; (2) geometric parameter detection; (3) surface quality detection; (5) integrating the detection results of the geometric parameters, the material performance, the surface quality and the functional performance measured in the steps (1)-(4), evaluating the performance of a single puncture needle, performing statistical analysis on the detection data of a plurality of puncture needles at the same time, and evaluating the consistency and the reliability of the puncture needles; and (6) quality evaluation and feedback. According to the full-process performance detection method and device for the slender puncture needle, all high-precision detection tasks are completed on the same machine, the detection precision and efficiency are remarkably improved, and the safety and reliability of the puncture needle in clinical application are ensured.

Description

Technical Field

[0001] The present invention relates to the field of medical device testing, and in particular to a method and a device for testing the full-process performance of a slender puncture needle which can be completed on the same machine. Background Art

[0002] Thin and long puncture needles are widely used in medical operations, such as establishing access, biopsy, infusion and blood drawing. Existing detection methods usually require the use of multiple devices, and have problems such as insufficient precision, complex detection process and low efficiency. Therefore, there is an urgent need for a method and device that can complete all detection tasks on the same machine to improve detection precision, simplify the process and improve efficiency. Summary of the invention

[0003] The technical problem to be solved by the present invention is to improve the detection of multiple puncture needles in the prior art, which requires the coordination of multiple devices and has the problems of insufficient precision, complicated detection process, low efficiency, etc.

[0004] The present invention adopts the following technical solution: a full-process performance detection method for a slender puncture needle, characterized in that it includes the following steps:

[0005] (1) Pretreatment: Clean and disinfect the puncture needle to ensure that it is free of impurities and contamination, and inspect the surface of the puncture needle through a built-in microscope to ensure that the puncture needle has no cracks or defects;

[0006] (2) Geometric parameter detection: The length, diameter, and tip angle of the puncture needle are accurately measured using a laser interferometry system, and a three-dimensional model of the puncture needle is obtained using a three-dimensional scanner;

[0007] (3) Surface quality inspection: The surface morphology and roughness of the puncture needle are measured by white light interferometry technology to provide a three-dimensional surface image. The profile and roughness of the puncture needle surface are measured using a stylus or optical profilometer. Laser scanning technology is used to obtain a high-resolution image of the puncture needle surface morphology and roughness, which is suitable for the inspection of complex surface structures.

[0008] (4) Functional performance testing: simulate the puncture operation, test the puncture force and puncture depth of the puncture needle, and test the rigidity and toughness of the puncture needle;

[0009] (5) Comprehensive performance evaluation: The test results of geometric parameters, material properties, surface quality and functional performance measured in steps (1)-(4) are integrated to evaluate the performance of a single puncture needle. At the same time, statistical analysis is performed on the test data of multiple puncture needles to evaluate the consistency and reliability of the puncture needles.

[0010] (6) Quality evaluation and feedback: Based on the comprehensive performance evaluation results of a single puncture needle in step (5), unqualified puncture needles are marked and removed, and the test results of multiple puncture needles are fed back to the production line to optimize and improve the production process and ensure the stability of subsequent product quality.

[0011] Preferably, the test control range of the test on the rigidity of the puncture needle in step (4) includes nominal specifications, tube wall, angle, print setting, test, left swing, right swing, time and calibration.

[0012] Preferably, the test control range of the test on the toughness of the puncture needle in step (4) includes nominal specifications, tube wall, span, set load, maximum deflection, print setting, test, up, down, time and calibration.

[0013] A detection device according to the full-process performance detection method for a slender puncture needle, characterized in that it includes the following functional modules:

[0014] Pretreatment module: Cleaning and disinfection unit: automatically cleans and disinfects the puncture needle to ensure that it is free of impurities and contamination; Microscopic inspection unit: inspects the surface of the puncture needle through a built-in microscope to ensure that it is free of cracks and defects;

[0015] Geometric parameter detection module: Laser measurement unit: uses a laser interferometer measurement system to accurately measure the length, diameter and tip angle of the puncture needle; 3D scanning unit: uses a 3D scanner to obtain a 3D model of the puncture needle for comprehensive geometric parameter analysis;

[0016] Surface quality inspection module: White light interferometer: Use white light interferometer technology to measure surface morphology and roughness, and provide a three-dimensional surface image; Profilometer: Use a stylus or optical profilometer to measure the profile and roughness of the surface; Laser confocal microscope: Use laser scanning technology to obtain high-resolution images of surface morphology and roughness, suitable for the inspection of complex surface structures;

[0017] Functional performance testing module: Automatic puncture test unit: simulates puncture operation, tests the puncture force and puncture depth of the puncture needle; Automatic rigidity test unit: measures the rigidity of the puncture needle; Automatic toughness test unit: measures the toughness of the puncture needle;

[0018] Comprehensive performance evaluation module: Data processing unit: Comprehensively evaluates the test results of geometric parameters, material properties, surface quality and functional performance; Big data analysis unit: Uses big data analysis and machine learning algorithms to perform statistical analysis on the test data and evaluate the consistency and reliability of the puncture needle;

[0019] Quality assessment and feedback module: Quality assessment unit: based on the comprehensive performance evaluation results, unqualified puncture needles are marked and removed; Feedback control unit: Feedback the test results to the production line, optimize and improve the production process, and ensure the stability of subsequent product quality.

[0020] Preferably, the preprocessing module, geometric parameter detection module, surface quality detection module, functional performance detection module, comprehensive performance evaluation module and quality evaluation and feedback module are all integrated on the same machine.

[0021] Preferably, the test control range of the automatic rigidity test unit includes nominal specifications, pipe wall, angle, print setting, test, left swing, right swing, time and calibration.

[0022] Preferably, the test control range of the automatic toughness test unit includes nominal specifications, pipe wall, span, set load, maximum deflection, print setting, test, up, down, time and calibration.

[0023] The present invention has the following beneficial effects: The present invention provides a full-process performance detection method and device for slender puncture needles. By completing various high-precision detection tasks on the same machine, the detection accuracy and efficiency are significantly improved, ensuring the safety and reliability of the puncture needle in clinical applications. The present invention uses laser interferometry, three-dimensional scanning, and other high-precision detection equipment to ensure higher detection precision. By optimizing the detection steps, the performance qualification rate of the puncture needle can be controlled to the greatest extent with the least steps, reducing the work difficulty and workload of the operator or maintenance personnel. Through automated detection equipment and big data analysis, the detection efficiency is significantly improved. The present invention comprehensively covers geometric parameters, material properties, surface quality and functional performance to ensure that the comprehensive performance of the puncture needle reaches the best state. The device provides an innovative solution for the quality control of medical devices, with broad application prospects and significant economic benefits. Integrated design: All detection functions are integrated on the same machine, simplifying the detection process. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0025] Figure 1 It is the operation flow chart of the present invention;

[0026] Figure 2 is an operation flow chart of the pre-processing module of the present invention;

[0027] Figure 3 It is an operation flow chart of the geometric parameter detection module of the present invention;

[0028] Figure 4 This is an operation flow chart of the surface quality detection module of the present invention;

[0029] Figure 5 This is an operation flow chart of the functional performance detection module of the present invention;

[0030] Figure 6 It is an operation flow chart of the comprehensive performance evaluation module and the quality evaluation and feedback module of the present invention. DETAILED DESCRIPTION

[0031] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work belong to the scope of protection of the present invention. Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the invention claimed for protection, but merely represents the selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work belong to the scope of protection of the present invention.

[0032] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0033] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0034] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0035] In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0036] Example

[0037] The following are only preferred implementations of the present invention. The protection scope of the present invention is not limited to the following embodiments. All technical solutions under the concept of the present invention belong to the protection scope of the present invention.

[0038] Reference Manual Attached Figure 1 , a full-process performance testing method for a slender puncture needle, comprising the following steps:

[0039] (1) Pretreatment: Clean and disinfect the puncture needle to ensure that it is free of impurities and contamination, and inspect the surface of the puncture needle through a built-in microscope to ensure that the puncture needle has no cracks or defects;

[0040] (2) Geometric parameter detection: The length, diameter, and tip angle of the puncture needle are accurately measured using a laser interferometry system, and a three-dimensional model of the puncture needle is obtained using a three-dimensional scanner;

[0041] (3) Surface quality inspection: The surface morphology and roughness of the puncture needle are measured by white light interferometry technology to provide a three-dimensional surface image. The profile and roughness of the puncture needle surface are measured using a stylus or optical profilometer. Laser scanning technology is used to obtain a high-resolution image of the puncture needle surface morphology and roughness, which is suitable for the inspection of complex surface structures.

[0042] (4) Functional performance test: simulate the puncture operation, test the puncture force and puncture depth of the puncture needle, and test the rigidity and toughness of the puncture needle; the test control range of the puncture needle rigidity test includes nominal specifications, tube wall, angle, print setting, test, left swing, right swing, time and calibration; the test control range of the puncture needle toughness test includes nominal specifications, tube wall, span, set load, maximum deflection, print setting, test, up, down, time and calibration.

[0043] (5) Comprehensive performance evaluation: The test results of geometric parameters, material properties, surface quality and functional performance measured in steps (1)-(4) are integrated to evaluate the performance of a single puncture needle. At the same time, statistical analysis is performed on the test data of multiple puncture needles to evaluate the consistency and reliability of the puncture needles. The specific evaluation method is as follows:

[0044] Evaluation of a single puncture needle: The data processing unit compares the measurement results of each parameter with the standard value to evaluate whether the performance of a single puncture needle is qualified. Consistency and reliability analysis of multiple puncture needles: The big data analysis unit uses big data analysis and machine learning algorithms to perform statistical analysis (such as mean, standard deviation, coefficient of variation, etc.) on the measurement data of multiple puncture needles, and evaluates the consistency of puncture needles and reliability between batches by specifying standard values ​​after data processing.

[0045] Table 1 Statistics of measurement data of multiple puncture needles

[0046]

[0047] Through the above steps, the performance of a single puncture needle can be systematically evaluated, and the test data of multiple puncture needles can be statistically analyzed to comprehensively evaluate the consistency and reliability of the puncture needles. This can help manufacturers and users ensure product quality and performance stability.

[0048] (6) Quality evaluation and feedback: Based on the comprehensive performance evaluation results of a single puncture needle in step (5), unqualified puncture needles are marked and removed, and the test results of multiple puncture needles are fed back to the production line to optimize and improve the production process and ensure the stability of subsequent product quality.

[0049] Reference Manual Attached Figure 2-6 According to the detection device for the full-process performance detection method of the slender puncture needle, the detection device includes the following functional modules:

[0050] Pretreatment module: Cleaning and disinfection unit: automatically cleans and disinfects the puncture needle to ensure that it is free of impurities and contamination; Microscopic inspection unit: inspects the surface of the puncture needle through a built-in microscope to ensure that it is free of cracks and defects;

[0051] Geometric parameter detection module: Laser measurement unit: uses a laser interferometer measurement system to accurately measure the length, diameter and tip angle of the puncture needle; 3D scanning unit: uses a 3D scanner to obtain a 3D model of the puncture needle for comprehensive geometric parameter analysis;

[0052] Surface quality inspection module: White light interferometer: Use white light interferometer technology to measure surface morphology and roughness, and provide a three-dimensional surface image; Profilometer: Use a stylus or optical profilometer to measure the profile and roughness of the surface; Laser confocal microscope: Use laser scanning technology to obtain high-resolution images of surface morphology and roughness, suitable for the inspection of complex surface structures;

[0053] Functional performance testing module: Automatic puncture test unit: simulates puncture operation, tests the puncture force and puncture depth of the puncture needle; Automatic rigidity test unit: measures the rigidity of the puncture needle; Automatic toughness test unit: measures the toughness of the puncture needle; The test control range of the automatic rigidity test unit includes nominal specifications, pipe wall, angle, print setting, test, left swing, right swing, time and calibration. The test control range of the automatic toughness test unit includes nominal specifications, pipe wall, span, set load, maximum deflection, print setting, test, up, down, time and calibration.

[0054] Comprehensive performance evaluation module: Data processing unit: Comprehensively evaluates the test results of geometric parameters, material properties, surface quality and functional performance; Big data analysis unit: Uses big data analysis and machine learning algorithms to perform statistical analysis on the test data and evaluate the consistency and reliability of the puncture needle;

[0055] Quality assessment and feedback module: Quality assessment unit: based on the comprehensive performance evaluation results, unqualified puncture needles are marked and removed; Feedback control unit: Feedback the test results to the production line, optimize and improve the production process, and ensure the stability of subsequent product quality.

[0056] The preprocessing module, geometric parameter detection module, surface quality detection module, functional performance detection module, comprehensive performance evaluation module and quality evaluation and feedback module are all integrated on the same machine.

[0057] The above embodiments are only for illustrating the technical concept and features of the present invention, and their purpose is to enable people familiar with the technology to understand the content of the present invention and implement it accordingly, and they cannot be used to limit the protection scope of the present invention. Any equivalent changes or modifications made according to the spirit of the present invention should be included in the protection scope of the present invention.

Claims

1. A full-process performance testing method for a slender puncture needle, characterized in that: The steps include: (1) Pretreatment: Clean and disinfect the puncture needle to ensure that it is free of impurities and contamination, and inspect the surface of the puncture needle through a built-in microscope to ensure that the puncture needle has no cracks or defects; (2) Geometric parameter detection: The length, diameter, and tip angle of the puncture needle are accurately measured using a laser interferometry system, and a three-dimensional model of the puncture needle is obtained using a three-dimensional scanner; (3) Surface quality inspection: The surface morphology and roughness of the puncture needle are measured by white light interferometry technology to provide a three-dimensional surface image. The profile and roughness of the puncture needle surface are measured using a stylus or optical profilometer. Laser scanning technology is used to obtain a high-resolution image of the puncture needle surface morphology and roughness, which is suitable for the inspection of complex surface structures. (4) Functional performance testing: simulate the puncture operation, test the puncture force and puncture depth of the puncture needle, and test the rigidity and toughness of the puncture needle; (5) Comprehensive performance evaluation: The test results of geometric parameters, material properties, surface quality and functional performance measured in steps (1) to (4) are integrated to evaluate the performance of a single puncture needle. At the same time, statistical analysis is performed on the test data of multiple puncture needles to evaluate the consistency and reliability of the puncture needles. (6) Quality evaluation and feedback: Based on the comprehensive performance evaluation results of a single puncture needle in step (5), unqualified puncture needles are marked and removed, and the test results of multiple puncture needles are fed back to the production line to optimize and improve the production process and ensure the stability of subsequent product quality.

2. The full-process performance testing method for a slender puncture needle according to claim 1, characterized in that: The test control range of the test on the rigidity of the puncture needle in the step (4) includes nominal specifications, tube wall, angle, print setting, test, left swing, right swing, time and calibration.

3. The full-process performance testing method for a slender puncture needle according to claim 1, characterized in that: The test control range of the test on the toughness of the puncture needle in the step (4) includes nominal specifications, tube wall, span, set load, maximum deflection, print setting, test, up, down, time and calibration.

4. A detection device for the full-process performance detection method of a slender puncture needle according to claims 1-3, characterized in that: Includes the following functional modules: Pretreatment module: Cleaning and disinfection unit: automatically cleans and disinfects the puncture needle to ensure that it is free of impurities and contamination; Microscopic inspection unit: inspects the surface of the puncture needle through a built-in microscope to ensure that it is free of cracks and defects; Geometric parameter detection module: Laser measurement unit: uses a laser interferometer measurement system to accurately measure the length, diameter and tip angle of the puncture needle; 3D scanning unit: uses a 3D scanner to obtain a 3D model of the puncture needle for comprehensive geometric parameter analysis; Surface quality inspection module: White light interferometer: Use white light interferometer technology to measure surface morphology and roughness, and provide a three-dimensional surface image; Profilometer: Use a stylus or optical profilometer to measure the profile and roughness of the surface; Laser confocal microscope: Use laser scanning technology to obtain high-resolution images of surface morphology and roughness, suitable for the inspection of complex surface structures; Functional performance testing module: Automatic puncture test unit: simulates puncture operation, tests the puncture force and puncture depth of the puncture needle; Automatic rigidity test unit: measures the rigidity of the puncture needle; Automatic toughness test unit: measures the toughness of the puncture needle; Comprehensive performance evaluation module: Data processing unit: Comprehensively evaluates the test results of geometric parameters, material properties, surface quality and functional performance; Big data analysis unit: Uses big data analysis and machine learning algorithms to perform statistical analysis on the test data and evaluate the consistency and reliability of the puncture needle; Quality assessment and feedback module: Quality assessment unit: based on the comprehensive performance evaluation results, unqualified puncture needles are marked and rejected; Feedback control unit: Feedback the test results to the production line, optimize and improve the production process, and ensure the stability of subsequent product quality.

5. The detection device according to claim 4, characterized in that: The preprocessing module, geometric parameter detection module, surface quality detection module, functional performance detection module, comprehensive performance evaluation module and quality evaluation and feedback module are all integrated on the same machine.

6. The detection device according to claim 4, characterized in that: The test control range of the automatic rigidity test unit includes nominal specifications, pipe wall, angle, print setting, test, left swing, right swing, time and calibration.

7. The detection device according to claim 4, characterized in that: The test control range of the automatic toughness test unit includes nominal specifications, pipe wall, span, set load, maximum deflection, print setting, test, up, down, time and calibration.

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