A quality inspection method for injection molding of vascular intervention balloon

Abstract

The present invention belongs to the technical field of quality inspection of vascular intervention balloon injection molding, and relates to a quality inspection and detection method for vascular intervention balloon injection molding. The present invention obtains the test precautions of vascular intervention balloons in advance by analyzing the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each vascular intervention balloon sample belonging to the target batch, improves the accuracy and reliability of the test results, and improves the treatment success rate, reduces the incidence of complications, and reduces medical accidents and losses caused by product failures by analyzing the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each vascular intervention balloon belonging to the target batch. By automatically generating a comprehensive quality inspection report for the vascular intervention balloon belonging to the target batch, it helps to prevent products that do not meet performance standards from entering the market, reduce potential risks, and also helps to compare the performance differences of different batches of vascular intervention balloons.

Description

Technical Field

[0001] The invention belongs to the technical field of quality inspection of vascular intervention balloon injection molding, and relates to a quality inspection method for vascular intervention balloon injection molding. Background Art

[0002] Vascular intervention balloon is a medical device, which is mainly used for dilation treatment of lesions such as vascular stenosis and heart valve stenosis. By using a catheter with a dilation balloon at the end, the doctor can accurately locate the lesion and expand the balloon by pressurizing the liquid to achieve the purpose of treatment. This treatment method has the advantages of less trauma, simple operation, and fewer complications, which greatly reduces the patient's pain and recovery time. With the improvement of people's living standards and the acceleration of the pace of life, the incidence of cardiovascular and cerebrovascular diseases has increased year by year, and it is showing a trend of younger age. Due to the key role of vascular intervention balloons in treatment, the requirements for their quality are also extremely strict. Therefore, the quality inspection system for vascular intervention balloon injection molding is of great significance and role.

[0003] The existing quality inspection system for vascular interventional balloon injection molding can basically meet the needs, but there are still certain shortcomings: on the one hand, the existing quality inspection system for vascular interventional balloon injection molding is to uniformly inspect the produced vascular interventional balloons, but the existing quality inspection system for vascular interventional balloon injection molding lacks random sampling from the produced vascular interventional balloons to obtain the testing precautions of the vascular interventional balloons in advance, and thus cannot achieve standardization and normalization of the inspection process, nor can it improve the accuracy and reliability of the inspection results.

[0004] On the other hand, the existing quality inspection system for vascular interventional balloon injection molding ignores the compilation of the inspection data and analysis results of the same batch of vascular interventional balloons, which is not conducive to comparing the performance differences between different batches of vascular interventional balloons, and is not conducive to identifying performance bottlenecks and technical bottlenecks, thereby promoting product research and development and technological upgrades. Summary of the invention

[0005] In view of this, in order to solve the problems raised in the above background technology, a quality inspection method for vascular intervention balloon injection molding is proposed.

[0006] The objective of the present invention can be achieved through the following technical scheme: The present invention provides a quality inspection method for vascular interventional balloon injection molding, including: S1, sampling performance data collection: used to record the vascular interventional balloons produced in the same batch to be inspected as the vascular interventional balloons belonging to the target batch, and randomly sample the vascular interventional balloon samples belonging to the target batch, and further perform performance testing on them to obtain the biological performance data, functional performance data and physical performance data of the vascular interventional balloon samples belonging to the target batch.

[0007] S2. Sampling performance data analysis: Analyze the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each vascular intervention balloon sample belonging to the target batch, and then obtain the comprehensive performance compliance rate of the vascular intervention balloon samples belonging to the target batch based on this analysis.

[0008] S3. Determine the need for re-inspection: Analyze the need for re-inspection of the vascular intervention balloons of the target batch. If re-inspection is required, execute S1; otherwise, execute S4.

[0009] S4. Comprehensive collection of performance data: used to record each vascular intervention balloon except for each vascular intervention balloon sample in the target batch as a designated vascular intervention balloon, and obtain the biological performance data, functional performance data and physical performance data of each designated vascular intervention balloon.

[0010] S5. Comprehensive analysis of performance data: Analyze the biological performance qualification indicators, functional performance qualification indicators and physical performance qualification indicators of each designated vascular intervention balloon, and provide feedback.

[0011] S6. Comprehensive analysis of performance data: Analyze the biological performance compliance rate, functional performance compliance rate, physical performance compliance rate and comprehensive performance compliance rate of the target batch of vascular interventional balloons, and automatically generate a comprehensive quality inspection report for the target batch of vascular interventional balloons and provide feedback.

[0012] Compared with the prior art, the beneficial effects of the present invention are as follows: 1. The present invention obtains the biological performance data, functional performance data and physical performance data of each vascular intervention balloon sample belonging to the target batch, thereby providing data support for the subsequent analysis of biological performance qualification indicators, functional performance qualification indicators, physical performance qualification indicators and comprehensive performance compliance rate.

[0013] 2. The present invention analyzes the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each vascular intervention balloon sample belonging to the target batch, and obtains the comprehensive performance compliance rate of the vascular intervention balloon samples belonging to the target batch, which helps to obtain the testing precautions of the vascular intervention balloon belonging to the target batch in advance, is conducive to the standardization and normalization of the detection process, and improves the accuracy and reliability of the detection results.

[0014] 3. The present invention helps to detect and analyze the quality of vascular intervention balloons from multiple dimensions such as biological performance, functional performance and physical performance by analyzing the biological performance qualification indicators, functional performance qualification indicators and physical performance qualification indicators of each designated vascular intervention balloon, thereby ensuring that the vascular intervention balloon will not cause adverse reactions such as biological toxicity and immune response to patients during use, which is beneficial to improving the treatment success rate, reducing the incidence of complications, and helping to reduce medical accidents and losses caused by product failures.

[0015] 4. The present invention analyzes the biological performance compliance rate, functional performance compliance rate, physical performance compliance rate and comprehensive performance compliance rate of the target batch of vascular interventional balloons, and automatically generates a comprehensive quality inspection report for the target batch of vascular interventional balloons. This helps to promptly discover and identify products or batches that do not meet performance standards, prevent them from entering the market, and reduce potential risks. It also helps to compare the performance differences of different batches of vascular interventional balloons, which is conducive to identifying performance bottlenecks and technical bottlenecks, thereby promoting product research and development and technological upgrades. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for describing the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying creative work.

[0017] Figure 1 It is a schematic diagram for implementing the method steps of the present invention.

[0018] Figure 2 It is a schematic diagram of the vascular intervention balloon of the present invention. DETAILED DESCRIPTION

[0019] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only 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 creative work are within the scope of protection of the present invention.

[0020] See also Figure 1As shown, the present invention provides a quality inspection method for vascular interventional balloon injection molding, and the specific steps are as follows: S1, sampling performance data collection: it is used to record the vascular interventional balloons produced in the same batch to be inspected as the vascular interventional balloons belonging to the target batch, and randomly sample the vascular interventional balloon samples belonging to the target batch, and further perform performance testing on them to obtain the biological performance data, functional performance data and physical performance data of the vascular interventional balloon samples belonging to the target batch.

[0021] It is necessary to further explain that the schematic diagram of the vascular intervention balloon is as follows Figure 2 shown.

[0022] As a preferred feasible embodiment, the biological performance data includes toxicity and skin allergy.

[0023] It is necessary to further explain that the reasons for using toxicity and skin allergy as biological performance data are: (1) Toxicity and skin allergy are important biological performance indicators. Vascular intervention balloons are medical devices that come into direct contact with human tissue and blood. If the balloon material is toxic, it may release harmful substances after implantation into the human body, causing damage to human cells, tissues and organs. If the material of the vascular intervention balloon causes skin allergies, it will not only cause discomfort and pain to the patient, but may also affect the treatment effect.

[0024] For example, vascular intervention balloons may be mixed with heavy metal ions, organic solvent residues, or incompletely polymerized monomers during the production process. These substances may interfere with the normal physiological functions of the human body, cause cytotoxic reactions, organ dysfunction, and even endanger life.

[0025] (2) In the development of vascular intervention balloons, it is necessary to select appropriate materials to meet clinical needs. By testing the presence of toxicity and skin allergy, the biosafety of different materials can be evaluated, providing a basis for material selection. At the same time, based on the test results, the materials can be optimized and improved to improve the biocompatibility of the materials and reduce the risk of toxicity and allergies.

[0026] It needs to be further explained that the specific method of obtaining the toxicity and skin allergy of each vascular interventional balloon sample belonging to the target batch is: soaking the material in a culture medium for a period of time, then culturing cells with the soaking solution, and observing the cell growth; if the cells cannot grow normally, the toxicity of each vascular interventional balloon sample belonging to the target batch is recorded as the presence of toxicity; if the cells grow normally, the toxicity of each vascular interventional balloon sample belonging to the target batch is recorded as the absence of toxicity.

[0027] Place each vascular intervention balloon sample belonging to the target batch on the skin of the test animals respectively, wait for the set period of time, and observe the skin reaction of the test animals corresponding to each vascular intervention balloon sample belonging to the target batch. If there is no abnormality on the skin of the test animal corresponding to a vascular intervention balloon sample belonging to the target batch, the skin allergy of the vascular intervention balloon sample belonging to the target batch will be recorded as no skin allergy; if there is an allergic reaction on the skin of the test animal corresponding to a vascular intervention balloon sample belonging to the target batch, the skin allergy of the vascular intervention balloon sample belonging to the target batch will be recorded as skin allergy.

[0028] It should be explained that the allergic reaction includes but is not limited to rash, erythema, itching and swelling.

[0029] The functional performance data include sealing degree, expansion speed, expansion uniformity and retractility evaluation index.

[0030] It should be further explained that the reasons for using sealing degree, expansion speed, expansion uniformity and retractility evaluation index as functional performance data are: (1) Sealing degree refers to whether there is leakage when the balloon is inflated. In vascular intervention surgery, the sealing degree of the balloon is directly related to the success of the surgery. Sealing degree assessment can ensure that the balloon can effectively seal the blood vessels after inflation and prevent blood leakage, thereby ensuring the safety and effectiveness of the surgery.

[0031] The expansion rate refers to the time required for the balloon to reach its maximum expansion state from the start of inflation. The expansion rate is one of the important indicators of the performance of vascular intervention balloons. An appropriate expansion rate can ensure that the balloon does not cause excessive impact or damage to the blood vessel wall during the expansion process, and can quickly achieve the expected expansion effect. Evaluating the expansion rate helps to understand the response speed and stability of the balloon during surgery, so as to select a balloon product that suits the surgical needs.

[0032] (3) Expansion uniformity refers to whether the balloon can expand evenly when inflated, rather than locally protruding or deforming. Expansion uniformity refers to the consistency of deformation of each part of the balloon during the expansion process. For vascular intervention balloons, uniform expansion can ensure that the vessel wall is subjected to uniform pressure, avoiding local over-expansion or under-expansion. Assessing expansion uniformity helps ensure that the balloon can evenly expand the blood vessel during the expansion process, improve surgical results, and reduce the occurrence of complications.

[0033] (4) Retractility refers to the ability of the balloon to return to its original state after expansion, that is, whether the balloon can return to its original size and shape after deflation. The retractility assessment index is used to measure the ability of the balloon to return to its original shape or size after expansion. This is crucial for vascular interventional surgery because the balloon needs to be quickly and completely retracted after surgery to avoid continued compression or damage to the blood vessel wall. Assessing retractility can help doctors understand the balloon's ability to recover after surgery, ensure that the balloon can be safely and effectively withdrawn from the blood vessel, and reduce surgical risks.

[0034] It needs to be further explained that the specific method of obtaining the sealing degree of each vascular intervention balloon sample belonging to the target batch is: immerse each vascular intervention balloon sample belonging to the target batch in water, and observe whether bubbles are generated. If no bubbles are generated in a vascular intervention balloon sample belonging to the target batch, the sealing degree of the vascular intervention balloon sample belonging to the target batch is recorded as 1; if bubbles are generated in a vascular intervention balloon sample belonging to the target batch, the sealing degree of the vascular intervention balloon sample belonging to the target batch is recorded as 0, thereby obtaining the sealing degree of each vascular intervention balloon sample belonging to the target batch.

[0035] The specific method for obtaining the expansion speed of each vascular intervention balloon sample belonging to the target batch is: connecting each vascular intervention balloon sample belonging to the target batch to a device that can accurately control the inflation rate, starting from zero pressure, and gradually increasing the pressure until the maximum expansion state is reached, recording the time required for each vascular intervention balloon sample belonging to the target batch to reach the maximum expansion state from the beginning of inflation and the balloon length in the maximum expansion state, and further dividing the balloon length in the maximum expansion state of each vascular intervention balloon sample belonging to the target batch by the corresponding time required from the beginning of inflation to reach the maximum expansion state, and recording the quotient as the expansion speed of each vascular intervention balloon sample belonging to the target batch.

[0036] The specific method for obtaining the expansion uniformity of each vascular intervention balloon sample belonging to the target batch is as follows: each vascular intervention balloon sample belonging to the target batch is connected to a device that can accurately control the inflation rate, starting from zero pressure, and gradually increasing the pressure until the maximum expansion state is reached, using a deployed high-speed camera to record the size changes of each vascular intervention balloon sample belonging to the target batch during the expansion process, and using image analysis software to obtain the expansion area of ​​each sub-region corresponding to each expansion of each vascular intervention balloon sample belonging to the target batch during the expansion process ,in , is the serial number of each vascular intervention balloon sample belonging to the target batch, is the number of vascular intervention balloon samples in the target batch, , is the number of each expansion, is the number of expansions, , is the number of each sub-region, is the number of sub-regions, and the expansion uniformity of each vascular intervention balloon sample in the target batch is analyzed. ,in The difference in the permitted expansion area is set.

[0037] For example, , indicating that the expansion area of ​​each sub-region is allowed to have a difference of 0.01%.

[0038] The specific method for obtaining the retractility evaluation index of each vascular intervention balloon sample belonging to the target batch is as follows: inflate each vascular intervention balloon sample belonging to the target batch to a predetermined pressure, maintain it for a period of time, and further slowly deflate it until it is no longer in its original state, use a deployed high-speed camera to record the recovery process of each vascular intervention balloon sample belonging to the target batch, and use image analysis software to obtain the balloon diameter of each vascular intervention balloon sample belonging to the target batch after deflation. and balloon length , analyze the retractility evaluation index of each vascular intervention balloon sample in the target batch .

[0039] The physical property data include peak tensile force, burst pressure, balloon diameter and balloon length.

[0040] It should be further explained that the peak tension, bursting pressure, balloon diameter and balloon length are used as physical performance data because: (1) Peak tension refers to the force limit that a balloon dilatation catheter can withstand when subjected to maximum tension. In vascular interventional surgery, a balloon dilatation catheter needs to pass through a winding path in the blood vessel to reach the lesion site. During this process, it needs to withstand friction from the blood vessel wall and pulling force during operation. The magnitude of the peak tension determines the stability and durability of the balloon catheter during surgery, preventing breakage or failure due to excessive tension.

[0041] (2) Burst pressure refers to the maximum pressure that the balloon can withstand under specific conditions. If this pressure is exceeded, the balloon will rupture. In vascular interventional surgery, the balloon needs to be inflated to dilate the blood vessels or compress the lesion. The burst pressure is an important parameter to ensure that the balloon will not rupture due to excessive pressure during the operation. It is directly related to the safety of the operation and avoids serious complications such as vascular damage and bleeding caused by balloon rupture.

[0042] (3) Balloon diameter refers to the diameter of the balloon in its fully expanded state. The choice of balloon diameter directly affects the effect of the surgery. Balloons of different diameters are suitable for vascular lesions of different sizes and locations. The appropriate balloon diameter can ensure that the balloon fits tightly against the vessel wall, achieving the desired expansion effect while reducing damage to the surrounding normal vascular tissue.

[0043] (4) Balloon length refers to the length of the balloon when it is fully expanded. The choice of balloon length also has an important impact on the surgical outcome. Longer balloons can cover longer lesion areas and are suitable for vascular lesions with long-segment stenosis or occlusion. Shorter balloons are suitable for short-segment lesions or situations where precise control of the expansion range is required. Reasonable choice of balloon length helps improve surgical accuracy and treatment outcomes.

[0044] It needs to be further explained that the specific method of obtaining the peak tensile force, bursting pressure, balloon diameter and balloon length of the target batch of vascular interventional balloon samples is: fix the target batch of vascular interventional balloon samples on a tensile testing machine, gradually increase the tensile force longitudinally, and record the maximum tensile force of the target batch of vascular interventional balloon samples before they break, which is recorded as the peak tensile force of the target batch of vascular interventional balloon samples.

[0045] Fix the vascular intervention balloon samples belonging to the target batch on the pressure testing device, gradually increase the inflation pressure, record the maximum inflation pressure of the vascular intervention balloon samples belonging to the target batch before rupture, and record it as the bursting pressure of the vascular intervention balloon samples belonging to the target batch.

[0046] The vascular intervention balloon samples belonging to the target batch are inflated to a fully expanded state, and the diameter and length of the vascular intervention balloon samples belonging to the target batch in the fully expanded state are measured using a vernier caliper. The obtained diameter and length are recorded as the balloon diameter and balloon length of the vascular intervention balloon samples belonging to the target batch.

[0047] The present invention obtains the biological performance data, functional performance data and physical performance data of each vascular intervention balloon sample belonging to the target batch, thereby providing data support for the subsequent analysis of the biological performance qualification indicators, functional performance qualification indicators, physical performance qualification indicators and the comprehensive performance compliance rate.

[0048] S2. Sampling performance data analysis: Analyze the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each vascular intervention balloon sample belonging to the target batch, and then obtain the comprehensive performance compliance rate of the vascular intervention balloon samples belonging to the target batch based on this analysis.

[0049] As a preferred feasible embodiment, the biological performance qualified index of each vascular intervention balloon sample belonging to the target batch is specifically analyzed in the following manner: extract the toxicity existence of each vascular intervention balloon sample belonging to the target batch; if the toxicity existence of a vascular intervention balloon sample belonging to the target batch is toxicity, then the toxicity existence index of the vascular intervention balloon sample belonging to the target batch is recorded as 1; if the toxicity existence of a vascular intervention balloon sample belonging to the target batch is non-toxicity, then the toxicity existence index of the vascular intervention balloon sample belonging to the target batch is recorded as 0, thereby obtaining the toxicity existence index of each vascular intervention balloon sample belonging to the target batch. ,in , is the serial number of each vascular intervention balloon sample belonging to the target batch, is the number of vascular intervention balloon samples belonging to the target batch.

[0050] The skin allergy index of each vascular intervention balloon sample belonging to the target batch is extracted. If the skin allergy index of a vascular intervention balloon sample belonging to the target batch is skin allergy, the skin allergy index of the vascular intervention balloon sample belonging to the target batch is recorded as 1. If the skin allergy index of a vascular intervention balloon sample belonging to the target batch is skin non-allergy, the skin allergy index of the vascular intervention balloon sample belonging to the target batch is recorded as 0, thereby obtaining the skin allergy index of each vascular intervention balloon sample belonging to the target batch. .

[0051] Analyze the biological performance indicators of each vascular intervention balloon sample in the target batch .

[0052] As a preferred feasible embodiment, the functional performance qualified index of each vascular intervention balloon sample of the target batch is specifically analyzed by extracting the sealing degree, expansion speed, expansion uniformity and retraction evaluation index of each vascular intervention balloon sample of the target batch, which are respectively recorded as , analyze the functional performance qualified indicators of each vascular intervention balloon sample in the target batch ,in are the standard expansion speed, standard expansion uniformity and retractility assessment index threshold of the vascular intervention balloon extracted from the database, are the allowable difference between the set expansion speed and the standard expansion speed, and the allowable difference between the expansion uniformity and the standard expansion uniformity, respectively. is a natural constant.

[0053] It should be further explained that the allowable difference between the expansion speed and the standard expansion speed and the allowable difference between the expansion uniformity and the standard expansion uniformity are both set to 0.0001, indicating that the allowable difference between the expansion speed and the standard expansion speed and the allowable difference between the expansion uniformity and the standard expansion uniformity may have a deviation of 0.01%.

[0054] As a preferred feasible embodiment, the physical performance qualified index of each vascular intervention balloon sample of the target batch is specifically analyzed by extracting the peak tension, bursting pressure, balloon diameter and balloon length of each vascular intervention balloon sample of the target batch, and recording them as , analyze the physical performance qualified indicators of each vascular intervention balloon sample in the target batch ,in are the peak tension threshold and burst pressure threshold of the vascular intervention balloon extracted from the database, They are the standard balloon diameter and standard balloon length of vascular intervention balloons extracted from the database, respectively.

[0055] As a preferred feasible embodiment, the comprehensive performance compliance rate of the target batch of vascular intervention balloon samples is specifically analyzed by extracting the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each vascular intervention balloon sample of the target batch, and then analyzing the qualified indicators according to the screening model. Obtain the comprehensive performance compliance of each vascular intervention balloon sample in the target batch ,in , is a non-sign, They are the set functional performance qualification index thresholds and physical performance qualification index thresholds respectively.

[0056] It needs to be further explained that This means that the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of the vascular intervention balloon samples are all up to standard.

[0057] Record the vascular intervention balloon samples of the target batch that meet the comprehensive performance standards as the vascular intervention balloon samples that meet the standards of the target batch, and count the number of vascular intervention balloon samples that meet the standards of the target batch. , analyze the comprehensive performance compliance rate of the target batch of vascular intervention balloon samples .

[0058] The present invention analyzes the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each vascular intervention balloon sample belonging to the target batch, and obtains the comprehensive performance compliance rate of the vascular intervention balloon samples belonging to the target batch, which helps to obtain the testing precautions of the vascular intervention balloon belonging to the target batch in advance, is conducive to the standardization and normalization of the detection process, and improves the accuracy and reliability of the detection results.

[0059] S3. Determine the need for re-inspection: Analyze the need for re-inspection of the vascular intervention balloons of the target batch. If re-inspection is required, execute S1; otherwise, execute S4.

[0060] As a preferred feasible embodiment, the need for re-inspection of the vascular interventional balloons belonging to the target batch is specifically judged in the following manner: extracting the comprehensive performance compliance rate of the vascular interventional balloon samples belonging to the target batch; if it is greater than the set comprehensive performance compliance rate threshold, the need for re-inspection of the vascular interventional balloons belonging to the target batch is recorded as a need not to re-inspect; otherwise, the need for re-inspection of the vascular interventional balloons belonging to the target batch is recorded as a need to re-inspect.

[0061] It needs to be further explained that the vascular intervention balloons obtained through multiple random inspections in the target batch are collectively referred to as vascular intervention balloon samples belonging to the target batch.

[0062] Specifically, if the need for re-inspection of the vascular interventional balloons belonging to the target batch is recorded as the need for re-inspection, then the vascular interventional balloon samples belonging to the target batch obtained in the first inspection will be recorded as the first-inspected vascular interventional balloon samples belonging to the target batch, and the vascular interventional balloon samples belonging to the target batch obtained in the second inspection will be recorded as the second-inspected vascular interventional balloon samples belonging to the target batch. At this time, each vascular interventional balloon sample belonging to the target batch is the accumulation of each first-inspection vascular interventional balloon sample belonging to the target batch and each second-inspection vascular interventional balloon sample belonging to the target batch.

[0063] S4. Comprehensive collection of performance data: used to record each vascular intervention balloon except for each vascular intervention balloon sample in the target batch as a designated vascular intervention balloon, and obtain the biological performance data, functional performance data and physical performance data of each designated vascular intervention balloon.

[0064] It is necessary to further explain that the matters that should be noted when obtaining the biological performance data, functional performance data and physical performance data of each designated vascular intervention balloon are as follows: extract the peak tension and burst pressure of each vascular intervention balloon sample in the target batch, and screen out the minimum peak tension and minimum burst pressure of the vascular intervention balloon samples in the target batch, and record them as the peak tension warning value and burst pressure warning value respectively. The tension and pressure used in each test when obtaining the biological performance data, functional performance data and physical performance data of each designated vascular intervention balloon should be less than the peak tension warning value and burst pressure warning value.

[0065] S5. Comprehensive analysis of performance data: Analyze the biological performance qualification indicators, functional performance qualification indicators and physical performance qualification indicators of each designated vascular intervention balloon, and provide feedback.

[0066] As a preferred feasible embodiment, the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each designated vascular intervention balloon, and its specific analysis method include: the method of obtaining the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each vascular intervention balloon sample belonging to the same target batch, and similarly, the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each designated vascular intervention balloon can be obtained.

[0067] The present invention helps to detect and analyze the quality of vascular intervention balloons from multiple dimensions such as biological performance, functional performance and physical performance by analyzing the biological performance qualification indicators, functional performance qualification indicators and physical performance qualification indicators of each designated vascular intervention balloon, thereby ensuring that the vascular intervention balloon will not cause adverse reactions such as biological toxicity and immune response to patients during use, which is beneficial to improving the treatment success rate, reducing the incidence of complications, and helping to reduce medical accidents and losses caused by product failures.

[0068] S6. Comprehensive analysis of performance data: Analyze the biological performance compliance rate, functional performance compliance rate, physical performance compliance rate and comprehensive performance compliance rate of the target batch of vascular interventional balloons, and automatically generate a comprehensive quality inspection report for the target batch of vascular interventional balloons and provide feedback.

[0069] As a preferred feasible embodiment, the biological performance compliance rate, functional performance compliance rate, physical performance compliance rate and comprehensive performance compliance rate of the vascular interventional balloons belonging to the target batch are specifically analyzed in the following manner: extracting the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each vascular interventional balloon sample randomly inspected belonging to the target batch and the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each designated vascular interventional balloon from the database, which are collectively referred to as the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each vascular interventional balloon belonging to the target batch.

[0070] Then, according to the predefined principles, the target batch of vascular access balloons with qualified biological performance, qualified functional performance and qualified physical performance is screened, and the number of vascular access balloons with qualified biological performance in the target batch is further counted. , Number of vascular access balloons that meet functional performance standards Number of vascular access balloons meeting physical performance standards .

[0071] It needs to be further explained that the specific contents according to the predefined principles include: if the biological performance qualified index of a vascular intervention balloon belonging to the target batch is 1, then the vascular intervention balloon belonging to the target batch will be recorded as the biological performance qualified vascular intervention balloon belonging to the target batch, and then the biological performance qualified vascular access balloons belonging to the target batch will be obtained.

[0072] If the functional performance qualified index of a vascular intervention balloon belonging to the target batch is greater than or equal to the functional performance qualified index threshold, the vascular intervention balloon belonging to the target batch will be recorded as the vascular intervention balloon with qualified functional performance belonging to the target batch, and then the vascular access balloons with qualified functional performance belonging to the target batch will be obtained.

[0073] If the qualified physical performance index of a vascular intervention balloon belonging to the target batch is greater than or equal to the qualified physical performance index threshold, the vascular intervention balloon belonging to the target batch will be recorded as the qualified physical performance vascular intervention balloon belonging to the target batch, and then all the qualified physical performance vascular access balloons belonging to the target batch will be obtained.

[0074] Calculate the biological performance compliance rate of the target batch of vascular intervention balloons ,in is the number of vascular intervention balloons in the target batch.

[0075] Similarly, the functional performance compliance rate and physical performance compliance rate of the target batch of vascular intervention balloons can be obtained.

[0076] The specific analysis method of the comprehensive performance compliance rate of the vascular intervention balloon samples belonging to the same target batch can obtain the comprehensive performance compliance rate of the vascular intervention balloon belonging to the target batch.

[0077] As a preferred feasible embodiment, the automatically generating a comprehensive quality inspection report of the target batch of vascular intervention balloons specifically includes: automatically generating a comprehensive quality inspection report of the target batch of vascular intervention balloons.

[0078] Among them, the comprehensive quality inspection report includes the testing methods and data results of the biological performance data, functional performance data and physical performance data of each vascular interventional balloon belonging to the target batch, as well as the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each vascular interventional balloon belonging to the target batch, and the biological performance compliance rate, functional performance compliance rate, physical performance compliance rate and comprehensive performance compliance rate of the vascular interventional balloon belonging to the target batch.

[0079] It needs to be explained that the vascular intervention balloons belonging to the target batch are a general term for the vascular intervention balloon samples belonging to the target batch and the designated vascular intervention balloons.

[0080] It needs to be further explained that, based on the comprehensive quality inspection report of the vascular interventional balloons belonging to the target batch, the specific reasons for the unqualified biological performance, unqualified functional performance and unqualified physical performance of each vascular interventional balloon belonging to the target batch are further analyzed.

[0081] It should be further explained that the specific reasons for the unqualified biological performance, unqualified functional performance and unqualified physical performance of each vascular intervention balloon belonging to the target batch of analysis include: (1) In view of the unqualified biological performance, check the source of raw materials, production technology and sterilization process to ensure that the product is sterile and non-toxic.

[0082] (2) In response to substandard functional performance, optimize product design to improve the balloon's sealing, expansion speed, expansion uniformity, and retractility to ensure that it meets clinical use requirements.

[0083] (3) In response to physical properties that do not meet the standards, strengthen the inspection and testing of product materials to ensure that the physical properties of the materials, such as peak tensile force, bursting pressure, balloon diameter and balloon length, meet the standards.

[0084] The present invention analyzes the biological performance compliance rate, functional performance compliance rate, physical performance compliance rate and comprehensive performance compliance rate of the vascular interventional balloons belonging to the target batch, and automatically generates a comprehensive quality inspection report for the vascular interventional balloons belonging to the target batch. This helps to promptly discover and identify products or batches that do not meet performance standards, prevent them from entering the market, and reduce potential risks. It also helps to compare the performance differences of different batches of vascular interventional balloons, which is conducive to identifying performance bottlenecks and technical bottlenecks, thereby promoting product research and development and technological upgrades.

[0085] The above contents are merely examples and explanations of the concept of the present invention. Those skilled in the art may make various modifications or additions to the specific embodiments described or replace them in a similar manner. As long as they do not deviate from the concept of the invention or exceed the scope defined by the present invention, they shall all fall within the protection scope of the present invention.

Claims

1. A quality inspection method for vascular intervention balloon injection molding, characterized in that: include: S1. Sampling performance data collection: used to record the vascular intervention balloons produced in the same batch to be tested as the vascular intervention balloons belonging to the target batch, randomly sample the vascular intervention balloon samples belonging to the target batch, further perform performance testing on them, and obtain the biological performance data, functional performance data, and physical performance data of the vascular intervention balloon samples belonging to the target batch; S2. Sampling performance data analysis: Analyze the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each vascular intervention balloon sample of the target batch, and then obtain the comprehensive performance compliance rate of the vascular intervention balloon samples of the target batch based on this analysis; S3. Determination of re-inspection demand: Analyze the re-inspection demand of the target batch of vascular intervention balloons. If re-inspection is required, execute S1; otherwise, execute S4. Among them, if its comprehensive performance compliance rate is greater than the set comprehensive performance compliance rate threshold, the re-inspection demand of the target batch of vascular intervention balloons is recorded as no need for re-inspection demand; otherwise, the re-inspection demand of the target batch of vascular intervention balloons is recorded as need for re-inspection demand; S4. Comprehensive performance data collection: used to record each vascular intervention balloon except each vascular intervention balloon sample in the target batch as a designated vascular intervention balloon, and obtain the biological performance data, functional performance data and physical performance data of each designated vascular intervention balloon; S5. Comprehensive analysis of performance data: Analyze the biological performance qualification indicators, functional performance qualification indicators and physical performance qualification indicators of each designated vascular intervention balloon and provide feedback; S6. Comprehensive analysis of performance data: Analyze the biological performance compliance rate, functional performance compliance rate, physical performance compliance rate and comprehensive performance compliance rate of the target batch of vascular intervention balloons, and automatically generate a comprehensive quality inspection report of the target batch of vascular intervention balloons and provide feedback; Among them, the specific analysis method of the comprehensive performance compliance rate of the target batch of vascular intervention balloon samples is as follows: Extract the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each vascular intervention balloon sample of the target batch, and then Obtain the comprehensive performance compliance of each vascular intervention balloon sample in the target batch ,in , is a non-sign, They are the set functional performance qualification index threshold and physical performance qualification index threshold; , , They are the biological performance qualified indicators, functional performance qualified indicators, and physical performance qualified indicators of each vascular intervention balloon sample; This means that the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of the vascular intervention balloon samples are all up to standard; Record the vascular intervention balloon samples of the target batch that meet the comprehensive performance standards as the vascular intervention balloon samples that meet the standards of the target batch, and count the number of vascular intervention balloon samples that meet the standards of the target batch. , analyze the comprehensive performance compliance rate of the target batch of vascular intervention balloon samples , is the number of vascular intervention balloon samples belonging to the target batch.

2. A quality inspection method for vascular intervention balloon injection molding according to claim 1, characterized in that: The biological performance data include toxicity presence and skin sensitization; The functional performance data include sealing degree, expansion speed, expansion uniformity and retraction evaluation index; The physical property data include peak tensile force, burst pressure, balloon diameter and balloon length.

3. A quality inspection method for vascular intervention balloon injection molding according to claim 2, characterized in that: The specific analysis method of the qualified biological performance indicators of each vascular intervention balloon sample of the target batch is as follows: Extract the toxicity existence of each vascular intervention balloon sample belonging to the target batch. If the toxicity existence of a vascular intervention balloon sample belonging to the target batch is toxic, the toxicity existence index of the vascular intervention balloon sample belonging to the target batch is recorded as 1. If the toxicity existence of a vascular intervention balloon sample belonging to the target batch is non-toxic, the toxicity existence index of the vascular intervention balloon sample belonging to the target batch is recorded as 0, thereby obtaining the toxicity existence index of each vascular intervention balloon sample belonging to the target batch. ,in , The serial number of each vascular intervention balloon sample belonging to the target batch; The skin allergy index of each vascular intervention balloon sample belonging to the target batch is extracted. If the skin allergy index of a vascular intervention balloon sample belonging to the target batch is skin allergy, the skin allergy index of the vascular intervention balloon sample belonging to the target batch is recorded as 1. If the skin allergy index of a vascular intervention balloon sample belonging to the target batch is skin non-allergy, the skin allergy index of the vascular intervention balloon sample belonging to the target batch is recorded as 0, thereby obtaining the skin allergy index of each vascular intervention balloon sample belonging to the target batch. ; Analyze the biological performance indicators of each vascular intervention balloon sample in the target batch .

4. A quality inspection method for vascular intervention balloon injection molding according to claim 3, characterized in that: The specific analysis methods for the functional performance qualified indicators of each vascular intervention balloon sample of the target batch include: The sealing degree, expansion speed, expansion uniformity and retraction evaluation index of each vascular intervention balloon sample of the target batch were extracted and recorded as , analyze the functional performance qualified indicators of each vascular intervention balloon sample in the target batch ,in are the standard expansion speed, standard expansion uniformity and retractility assessment index threshold of the vascular intervention balloon extracted from the database, are the allowable difference between the set expansion speed and the standard expansion speed, and the allowable difference between the expansion uniformity and the standard expansion uniformity, respectively. is a natural constant.

5. A quality inspection method for vascular intervention balloon injection molding according to claim 4, characterized in that: The specific analysis method of the qualified physical performance indicators of each vascular intervention balloon sample of the target batch is as follows: The peak tension, bursting pressure, balloon diameter and balloon length of each vascular intervention balloon sample of the target batch are extracted and recorded as , analyze the physical performance qualified indicators of each vascular intervention balloon sample in the target batch ,in are the peak tension threshold and burst pressure threshold of the vascular intervention balloon extracted from the database, They are the standard balloon diameter and standard balloon length of vascular intervention balloons extracted from the database, respectively.

6. A quality inspection method for vascular intervention balloon injection molding according to claim 1, characterized in that: The specific analysis methods of the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each designated vascular intervention balloon include: The biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each vascular intervention balloon sample belonging to the same target batch are obtained. Similarly, the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each designated vascular intervention balloon can be obtained.

7. A quality inspection method for vascular intervention balloon injection molding according to claim 6, characterized in that: The specific analysis methods for the biological performance compliance rate, functional performance compliance rate, physical performance compliance rate and comprehensive performance compliance rate of the target batch of vascular intervention balloons include: Extract the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each vascular intervention balloon sample of each random inspection belonging to the target batch and the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each designated vascular intervention balloon from the database, and collectively refer to them as the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each vascular intervention balloon belonging to the target batch; Then, according to the predefined principles, the target batch of vascular access balloons with qualified biological performance, qualified functional performance and qualified physical performance is screened, and the number of vascular access balloons with qualified biological performance in the target batch is further counted. , Number of vascular access balloons that meet functional performance standards Number of vascular access balloons meeting physical performance standards ; Calculate the biological performance compliance rate of the target batch of vascular intervention balloons ,in The number of vascular intervention balloons in the target batch; Similarly, the functional performance compliance rate and physical performance compliance rate of the target batch of vascular intervention balloons can be obtained; The specific analysis method of the comprehensive performance compliance rate of the vascular intervention balloon samples belonging to the same target batch can obtain the comprehensive performance compliance rate of the vascular intervention balloon belonging to the target batch.

8. A quality inspection method for vascular intervention balloon injection molding according to claim 7, characterized in that: The automatic generation of a comprehensive quality inspection report for the target batch of vascular intervention balloons specifically includes: Automatically generate comprehensive quality inspection reports for the target batch of vascular intervention balloons; Among them, the comprehensive quality inspection report includes the testing methods and data results of the biological performance data, functional performance data and physical performance data of each vascular interventional balloon belonging to the target batch, as well as the biological performance qualified indicators, functional performance qualified indicators and physical performance qualified indicators of each vascular interventional balloon belonging to the target batch, and the biological performance compliance rate, functional performance compliance rate, physical performance compliance rate and comprehensive performance compliance rate of the vascular interventional balloon belonging to the target batch.

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