Angiographic catheter application performance detection system and method

Abstract

The invention relates to the field of angiographic catheter performance detection, is used for solving the problem that the ability to detect the change condition in the catheter detection process is insufficient when the angiographic catheter performance is tested, and particularly relates to an angiographic catheter application performance detection system and method. Testing a tail-section acquisition module and a process result output module; in the angiographic catheter testing process, the angiographic catheter parameters in the process are continuously collected, the real-time change condition of the angiographic catheter in the whole testing process is obtained, the defects that in traditional detection, data at a single time point are in one piece, and the dynamic performance of the catheter cannot be reflected are overcome, meanwhile, the deformation degree of the catheter is collected, and the accuracy of the dynamic performance of the catheter is improved. The out-of-round situation of the angiographic catheter in the using process is simulated, the situation that deformation of the angiographic catheter is not uniform when the angiographic catheter bears pressure can be known more accurately, and the situation that thrombus formation is increased due to the fact that deformation of the angiographic catheter is not uniform in the actual using process is prevented.

Description

Technical Field

[0001] The present invention relates to the field of performance detection of contrast catheters, and specifically to a system and method for detecting the application performance of contrast catheters. Background Art

[0002] Angiography is a method of rapidly injecting a contrast agent through a catheter into the heart cavity or blood vessels, so that the heart and blood vessel cavities are visualized under X-ray irradiation. At the same time, methods such as rapid radiography, television photography, or magnetic tape recording are used to photograph the visualization process of the heart and blood vessel cavities. From the visualization results, the blood flow sequence containing the contrast agent and the filling condition of the heart blood vessels can be seen. It is a very valuable method for diagnosing heart and blood vessel diseases.

[0003] A contrast catheter is a key device for percutaneous angiography. It should have appropriate hardness, elasticity, flexibility, and torsion, as well as good X-ray penetration performance, good shape memory, a smooth tube wall, high contrast performance, and the thrombus formation performance should be controlled within the lowest range. Therefore, a contrast catheter should meet the following basic conditions: the inner tube is smooth and can generate high flow, high imaging performance, a non-invasive tip, and extremely high performance in maintaining the original shape and not being easily deformed, and it can easily accommodate a guide wire to pass through, etc.

[0004] However, diagnostic contrast catheters can be divided into selective contrast catheters and non-selective contrast catheters. Among them, common non-selective contrast catheters include: multi-side hole pigtail contrast catheters and multi-side hole straight tip contrast catheters; Therefore, the contrast catheter is the basis of angiography, and the performance of the contrast catheter is related to the effect and safety of angiography. The traditional contrast catheter detection technology still uses common mechanical detection equipment to detect the mechanical bearing limit of the catheter, ignoring the changes in the contrast catheter during the detection process. During the use of the contrast catheter, the change in the diameter of the catheter may directly affect its thrombus formation performance, which is directly related to the life of the patient. Therefore, a detection method that can more accurately obtain the changes in the contrast catheter during the detection process is needed. Summary of the Invention

[0005] During the testing process of the contrast catheter of the present invention, on the one hand, the testing limit of the contrast catheter is monitored, and the testing continues when the contrast catheter has not reached the limit. At the same time, during the process when the contrast catheter reaches the testing limit, the parameters of the contrast catheter during the process are continuously collected, and real-time analysis is carried out based on the collected results. According to the analysis results, the real-time changes of the contrast catheter throughout the test are obtained, avoiding the defect that the data at a single time point in traditional detection is one-sided and cannot reflect the dynamic performance of the catheter, and solving the problem of insufficient detection ability for the changes in the contrast catheter during the catheter detection process during the performance test of the contrast catheter, and a system and method for detecting the application performance of the contrast catheter are proposed.

[0006] The object of the present invention can be achieved by the following technical solutions: A contrast catheter application performance detection system, including a performance test module, which obtains the initial parameters of the contrast catheter by manual input, executes through a set performance test process, and automatically monitors the operating parameters of the contrast catheter during the execution process to confirm the usability of the catheter according to the operating parameters; A test middle section acquisition module, which acquires catheter parameters during the catheter test process and records the acquired catheter parameters as middle section parameters; A test end section acquisition module, which acquires catheter parameters at the moment when the performance test of the contrast catheter is completed, records them as end instantaneous parameters, and continues to acquire catheter parameters for a certain period of time after the performance test is completed, and records them as end continuous parameters; A process result output module, which obtains middle section parameters through the test middle section acquisition module, obtains end instantaneous parameters and end continuous parameters through the test end section acquisition module, and selects and analyzes the middle section parameters, end instantaneous parameters and end continuous parameters to generate a variation performance curve and a limit performance curve; A final result output module, which obtains the initial parameters of the contrast catheter through the performance test module, and comprehensively outputs according to the variation performance curve and the limit performance curve to obtain the contrast catheter application performance test result.

[0007] As a preferred embodiment of the present invention, the initial parameters of the contrast catheter obtained by the performance test module include the initial length, initial thickness and initial inner diameter of the contrast catheter. During the performance test process, the performance test module obtains the real-time catheter parameters of the contrast catheter, and the real-time catheter parameters of the contrast catheter include the pressure inside the tube, the inner diameter of the tube and the thickness of the tube; The performance test module continuously records the pressure inside the tube, draws a pressure variation curve with time as the horizontal axis and the pressure inside the tube as the vertical axis. The performance test module compares the pressure variation curve with the pressurization curve during the test process, and compares the part of the pressure variation curve below the pressurization curve with a set threshold. If the pressure on the pressure variation curve below the pressurization curve exceeds the set threshold, a pressure leakage signal is generated and the performance test is stopped; The performance test module respectively compares the inner diameter and thickness of the tube in the real-time catheter parameters with the inner diameter and thickness of the tube in the initial parameters to obtain an inner diameter deviation and a tube deviation. If the inner diameter deviation is greater than the corresponding threshold, or the tube deviation is greater than the corresponding threshold, a test failure signal is generated and the performance test is stopped.

[0008] As a preferred embodiment of the present invention, the catheter parameters collected by the middle-stage acquisition module and the end-stage acquisition module of the test include catheter inner diameter, catheter thickness, and catheter deformation degree; When the middle-stage acquisition module and the end-stage acquisition module of the test obtain catheter parameters each time, they are obtained at multiple different positions of the catheter to be tested and are respectively recorded as the i-th group of catheter parameters, where i = 1, 2, 3…, n; The middle-stage acquisition module of the test records the i-th catheter parameter obtained each time, thereby forming the i-th catheter parameter set.

[0009] As a preferred embodiment of the present invention, the middle-stage acquisition module of the test selects the catheter inner diameter in the i-th catheter parameter set, calculates the difference between the inner diameters of adjacent two groups according to the time arrangement order, records the difference as the catheter inner diameter change value, and generates a curve of the catheter inner diameter change value varying with the test time; The middle-stage acquisition module of the test selects both the catheter thickness and the catheter deformation degree in the i-th catheter set, and similarly generates a curve of the catheter thickness change value varying with time and a curve of the catheter deformation degree varying with the test time.

[0010] As a preferred embodiment of the present invention, the middle-stage acquisition module of the test fits the curves of the i-th group of catheter inner diameter change values varying with the test time to obtain an inner diameter change mean curve, and the inner diameter change mean curve represents the change of the inner diameter change mean of the contrast catheter with the test time; The middle-stage acquisition module of the test respectively fits the curves of the i-th group of catheter thickness change values varying with time and the curves of the i-th group of catheter deformation degrees varying with the test time to obtain a thickness change mean curve and a deformation degree mean curve.

[0011] As a preferred embodiment of the present invention, the method for obtaining the catheter deformation degree is as follows: During the test, the middle-stage acquisition module of the test compares the figure formed by the inner diameter of the contrast catheter with a standard perfect circle, obtains the area enclosed by the figure formed by the inner diameter and the standard perfect circle, calculates the ratio of the area of the region to the area of the selected standard perfect circle to obtain the catheter deformation degree. When the inner diameter of the contrast catheter still maintains a perfect circle, the catheter deformation degree is 0.

[0012] As a preferred embodiment of the present invention, the process result output module combines the inner diameter change mean curve, the thickness change mean curve, and the deformation degree mean curve into the same coordinate system and records them as a change performance curve; The process result output module creates a coordinate system, records the end instantaneous parameters and the end continuous parameters in the coordinate system, and performs minimum value fitting on i pipe inner diameter curves, pipe thickness curves and pipe deformation of the pipe inner diameter in the coordinate system, thereby generating three limit performance curves.

[0013] As a preferred implementation of the present invention, the method for performing minimum value fitting by the process result output module is: The process result output module selects i ordinates corresponding to the same abscissa on i curves, retains the lowest group of i ordinates, and performs the above operation on each abscissa, thereby completing the lowest value fitting.

[0014] The present invention also provides a method for detecting the application performance of angiography catheter, comprising the following steps: Step 1: Catheter testing process parameter monitoring; Step 2: End the test when the parameter exceeds the standard; Step 3: Test process parameter collection and analysis result visualization output; Step 4: End parameter and end rebound parameter collection; Step 5: Process parameters and end parameters are combined to generate process results; Step 6: Output the process results.

[0015] Compared with the prior art, the present invention has the following beneficial effects: 1. In the present invention, during the test of the angiography catheter, on the one hand, the test limit of the angiography catheter is supervised, and the test is continued when the angiography catheter has not reached the limit. At the same time, when the angiography catheter reaches the test limit, the angiography catheter parameters in the process are continuously collected, and the collected results are analyzed in real time. According to the analysis results, the real-time changes of the angiography catheter throughout the test are obtained, avoiding the defects of the traditional detection that the data at a single time point is one-sided and cannot reflect the dynamic performance of the catheter.

[0016] 2. In the present invention, when testing the catheter, in addition to collecting direct data on the thickness and inner diameter of the catheter, the deformation of the catheter is also collected, thereby simulating the out-of-roundness of the angiographic catheter during use, and being able to more accurately understand the uneven deformation of the angiographic catheter when it is under pressure, thereby preventing the increase in thrombogenicity caused by the uneven deformation of the angiographic catheter during actual use. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to facilitate understanding by those skilled in the art, the present invention is further described below with reference to the accompanying drawings.

[0018] Figure 1 is a system flow chart of the present invention; Figure 2 It is the system block diagram of the present invention; Figure 3 It is the method flowchart of the present invention. Specific embodiments

[0019] Next, the technical solution of the present invention will be clearly and completely described in conjunction with the embodiments. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work belong to the scope of protection of the present invention.

[0020] Embodiment 1: Please refer to Figure 1 - Figure 3 As shown, a performance detection system for the application performance of a contrast catheter includes a performance test module, a middle-section acquisition module for testing, an end-section acquisition module for testing, a process result output module, and a final result output module; The performance test module obtains the initial parameters of the contrast catheter through manual input and executes through a set performance test process. The initial parameters of the contrast catheter obtained by the performance test module include the initial length, initial thickness, and initial inner diameter of the contrast catheter. During the performance test, the performance test module obtains the real-time catheter parameters of the contrast catheter. The real-time catheter parameters of the contrast catheter include the pressure inside the catheter, the inner diameter of the catheter, and the thickness of the catheter, and determines the availability of the catheter according to the operating parameters; The method for judging the availability of the catheter is as follows: The performance test module continuously records the pressure inside the catheter, plots a pressure change curve with time as the horizontal axis and the pressure inside the catheter as the vertical axis. The performance test module compares the pressure change curve with the pressure increase curve during the test process, and compares the part of the pressure change curve below the pressure increase curve with a set threshold. If the pressure on the pressure change curve corresponding to the same abscissa is lower than the pressure on the pressure increase curve by more than the set threshold, a pressure leakage signal is generated and the performance test is stopped; The performance test module separately compares the inner diameter and thickness of the catheter in the real-time catheter parameters with the inner diameter and thickness of the catheter in the initial parameters to obtain an inner diameter deviation and a catheter deviation. If the inner diameter deviation is greater than the corresponding threshold, or the catheter deviation is greater than the corresponding threshold, it indicates that the change degree of the inner diameter of the contrast catheter is greater than the maximum degree allowed by the standard or the change degree of the thickness of the contrast catheter is greater than the maximum degree allowed by the standard, indicating that the contrast catheter has failed, and a test failure signal is generated and the performance test is stopped. Among them, the corresponding threshold is determined by the tester according to the catheter model, industry standard, and test standard to be tested.

[0021] Embodiment 2: Please refer to Figure 1 - Figure 3As shown, during the catheter test, the middle-section acquisition module collects catheter parameters and records the collected catheter parameters as middle-section parameters. The end-section acquisition module collects catheter parameters at the moment when the performance test of the contrast catheter is completed, records them as end-instantaneous parameters, and continues to collect catheter parameters for a certain period of time after the performance test is completed, and records them as end-continuous parameters; The catheter parameters collected by the middle-section acquisition module and the end-section acquisition module include catheter inner diameter, catheter thickness, and catheter deformation degree; Each time the middle-section acquisition module and the end-section acquisition module obtain catheter parameters, they are obtained at multiple different parts of the catheter under test, so as to increase the sample size, and are respectively recorded as the i-th group of catheter parameters, where i = 1, 2, 3…, n; The middle-section acquisition module records the i-th catheter parameters obtained each time, thereby forming the i-th catheter parameter set; The middle-section acquisition module selects the catheter inner diameters in the i-th catheter parameter set, calculates the difference between the adjacent two groups of catheter inner diameters according to the time arrangement order, records the difference as the catheter inner diameter change value, and generates a curve of the catheter inner diameter change value changing with the test time; The middle-section acquisition module selects both the catheter thickness and the catheter deformation degree in the i-th catheter set, and performs difference calculation in accordance with the same method according to the time sequence, and generates a curve of the catheter thickness change value changing with time and a curve of the catheter deformation degree changing with the test time according to the difference; The middle-section acquisition module fits the curves of the i-group catheter inner diameter change values changing with the test time to obtain an inner diameter change mean curve, and the inner diameter change mean curve represents the change of the inner diameter change mean of the contrast catheter with the test time; The middle-section acquisition module respectively fits the curves of the i-group catheter thickness change values changing with time and the curves of the i-group catheter deformation degrees changing with the test time to obtain a thickness change mean curve and a deformation degree mean curve; The method for obtaining the catheter deformation degree is: During the test, the middle-section acquisition module compares the shape formed by the inner diameter of the contrast catheter with a standard perfect circle, obtains the area enclosed by the shape formed by the inner diameter and the standard perfect circle, and calculates the ratio of the area of the region to the area of the selected standard perfect circle to obtain the catheter deformation degree. When the inner diameter of the contrast catheter still maintains a perfect circle, the catheter deformation degree is 0; The process result output module obtains the middle-section parameters through the middle-section acquisition module, and obtains the end-instantaneous parameters and the end-continuous parameters through the end-section acquisition module; The process result output module combines the inner diameter change mean curve, the thickness change mean curve, and the deformation degree mean curve into the same coordinate system and records them as the change performance curve; The process result output module creates a coordinate system, records the end instantaneous parameters and end duration parameters in the coordinate system, and performs minimum value fitting on the i pipeline inner diameter curves, pipeline thickness curves, and pipeline deformation degrees of the inner diameter of the pipeline in the coordinate system, thereby generating three limit performance curves; The method for the process result output module to perform minimum value fitting is as follows: The process result output module selects the i ordinates corresponding to the same abscissa on the i curves, retains the lowest group among the i ordinates, and performs the above operations on each abscissa, thereby completing the minimum value fitting; The final result output module obtains the initial parameters of the contrast catheter through the performance test module, and performs comprehensive output based on the variable performance curve and the limit performance curve to obtain the application performance test result of the contrast catheter.

[0022] Embodiment 3: Please refer to Figure 1 - Figure 3 As shown, the present invention also proposes a method for detecting the application performance of a contrast catheter, including the following steps: Step 1: Detect the parameters of the catheter thickness, inner diameter, and internal pressure during the catheter test; Step 2: Calculate the changes in the catheter thickness, catheter inner diameter, and internal pressure. When the changes exceed the set standard, it is determined that the test fails and the test ends; Step 3: When the test is not over, collect the parameters of the pipeline inner diameter, pipeline thickness, and pipeline deformation degree during the test, calculate the dynamic change range of the collected results, and visually output the calculation results through a chart; Step 4: Collect the end instantaneous parameters and end duration parameters after the test is completed; Step 5: Conduct a comprehensive analysis of the process parameters and end parameters to generate the process performance and limit performance of the catheter test; Step 6: Output the process results.

[0023] The preferred embodiments of the present invention disclosed above are only used to help explain the present invention. The preferred embodiments do not describe all the details in detail, nor do they limit the invention to only the specific implementation manners. Obviously, many modifications and variations can be made according to the content of this specification. These embodiments are selected and specifically described in this specification to better explain the principles and practical applications of the present invention, so that those skilled in the relevant technical fields can understand and utilize the present invention well. The present invention is only limited by the claims and their full scope and equivalents.

Claims

1. A performance detection system for contrast catheters, characterized in that, It includes a performance test module. The performance test module obtains the initial parameters of the contrast catheter through manual input, executes through a set performance test process, automatically monitors the operating parameters of the contrast catheter during the execution process, and confirms the availability of the catheter according to the operating parameters; A test middle-section acquisition module. The test middle-section acquisition module acquires catheter parameters during the catheter test process and records the acquired catheter parameters as middle-section parameters; A test end-section acquisition module. The test end-section acquisition module acquires catheter parameters at the moment when the performance test of the contrast catheter is completed, records them as end instantaneous parameters, and continues to acquire catheter parameters for a certain period of time after the performance test is completed, and records them as end continuous parameters; A process result output module. The process result output module obtains middle-section parameters through the test middle-section acquisition module, obtains end instantaneous parameters and end continuous parameters through the test end-section acquisition module, and selects and analyzes the middle-section parameters, end instantaneous parameters and end continuous parameters to generate a variation performance curve and a limit performance curve; A final result output module. The final result output module obtains the initial parameters of the contrast catheter through the performance test module, and comprehensively outputs according to the variation performance curve and the limit performance curve to obtain the application performance test result of the contrast catheter.

2. The performance detection system for the application of a contrast catheter according to claim 1, wherein The initial parameters of the contrast catheter obtained by the performance test module include the initial length, initial thickness and initial inner diameter of the contrast catheter. During the performance test process, the performance test module obtains the real-time catheter parameters of the contrast catheter, and the real-time catheter parameters of the contrast catheter include the pressure inside the tube, the inner diameter of the tube and the thickness of the tube; The performance test module continuously records the pressure inside the tube, takes time as the horizontal axis and the pressure inside the tube as the vertical axis to draw a pressure variation curve. The performance test module compares the pressure variation curve with the pressurization curve during the test process, and compares the part of the pressure variation curve lower than the pressurization curve with a set threshold. If the pressure on the pressure variation curve lower than the pressurization curve exceeds the set threshold, a pressure leakage signal is generated and the performance test is stopped; The performance test module separately compares the inner diameter and thickness of the tube in the real-time catheter parameters with the inner diameter and thickness of the tube in the initial parameters to obtain an inner diameter deviation and a tube deviation. If the inner diameter deviation is greater than the corresponding threshold, or the tube deviation is greater than the corresponding threshold, a test failure signal is generated and the performance test is stopped.

3. The performance detection system for the application of a contrast catheter according to claim 1, wherein The catheter parameters collected by the test middle-section acquisition module and the test end-section acquisition module include the inner diameter of the catheter, the thickness of the catheter and the degree of catheter deformation; Each time the test middle-section acquisition module and the test end-section acquisition module obtain catheter parameters, they are obtained at multiple different parts of the catheter to be tested and are respectively recorded as the i-th group of catheter parameters, i = 1, 2, 3…, n; The test middle-section acquisition module records the i-th catheter parameter obtained each time, thereby forming the i-th catheter parameter set.

4. The performance detection system for the application of a contrast catheter according to claim 3, wherein The test middle-section acquisition module selects the inner diameter of the catheter in the i-th catheter parameter set, calculates the difference between the inner diameters of two adjacent groups in the order of time arrangement, records the difference as the catheter inner diameter change value, and generates a curve of the catheter inner diameter change value varying with the test time; The test middle-section acquisition module selects both the catheter thickness and the catheter deformation degree in the i-th catheter set, and similarly generates a curve of the catheter thickness change value varying with time and a curve of the catheter deformation degree varying with the test time.

5. The performance detection system for the application of a contrast catheter according to claim 4, characterized in that, The test middle-section acquisition module fits the curves of the i-group catheter inner diameter change values varying with the test time to obtain an inner diameter change mean curve, and the inner diameter change mean curve represents the variation of the inner diameter change mean of the contrast catheter with the test time; The test middle-section acquisition module respectively fits the curves of the i-group catheter thickness change values varying with time and the curves of the i-group catheter deformation degrees varying with the test time to obtain a thickness change mean curve and a deformation degree mean curve.

6. The performance detection system for a contrast catheter application according to claim 4, wherein, The method for obtaining the catheter deformation degree is as follows: During the test, the test middle-section acquisition module compares the shape formed by the inner diameter of the contrast catheter with a standard perfect circle, obtains the area enclosed by the shape formed by the inner diameter and the standard perfect circle, calculates the ratio of the area of the region to the area of the selected standard perfect circle to obtain the catheter deformation degree. When the inner diameter of the contrast catheter still maintains a perfect circle, the catheter deformation degree is 0.

7. The performance detection system for the application of a contrast catheter according to claim 1, characterized in that, The process result output module combines the inner diameter change mean curve, the thickness change mean curve, and the deformation degree mean curve into the same coordinate system and records it as a change performance curve; The process result output module creates a coordinate system, records the end instantaneous parameter and the end duration parameter in the coordinate system, and performs the lowest value fitting on the i inner diameter curves, the pipe thickness curves, and the pipe deformation degrees of the pipe inner diameter in the coordinate system, thereby generating three limit performance curves.

8. The performance detection system for application of a contrast catheter according to claim 7, wherein, The method for the process result output module to perform the lowest value fitting is as follows: The process result output module selects the i ordinates corresponding to the same abscissa on the i curves and retains the lowest group among the i ordinates. The above operation is performed for each abscissa to complete the lowest value fitting.

9. A method for detecting the application performance of a contrast catheter, which uses a contrast catheter application performance detection system as described in any one of claims 1-8, characterized in that, It includes the following steps: Step 1: Monitor the process parameters of the catheter test; Step 2: End the test when the parameters exceed the standard; Step 3: Collect the process parameters of the test and visually output the analysis results; Step 4: Collect the end parameters and the end rebound parameters; Step 5: Comprehensively generate the process result from the process parameters and the end parameters; Step 6: Output the process result.

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