Microcatheter sizing device and control method

Abstract

The application discloses a microcatheter shaping device and a control method, wherein the microcatheter shaping device comprises a hot air output module for generating and outputting hot air with controllable temperature and flow rate; a hot steam output module for generating and outputting hot steam with controllable temperature and flow rate; a mixing cavity connected with the hot air output module and the hot steam output module respectively, for receiving the hot air and the hot steam and mixing them to form a gas-steam mixture which is then output to a microcatheter placement area; and a control unit connected with the hot air output module and the hot steam output module respectively, for coordinating and controlling the output parameters of the hot air and the hot steam to realize the collaborative shaping of the hot air and the hot steam. In the scheme, the control unit can adjust the output parameters of the hot air and the hot steam, and the mixing cavity can uniformly mix the two media, thereby effectively avoiding the shaping defects of the microcatheter caused by local temperature or humidity unevenness, and improving the shaping quality and the finished product qualification rate of the microcatheter.

Description

Technical Field

[0001] This application generally relates to the field of interventional surgical catheter technology. More specifically, this application relates to a microcatheter shaping device; further, this application also relates to a microcatheter shaping control method. Background Technology

[0002] Microcatheters are key instruments in interventional medicine, primarily used to deliver interventional devices and drugs within narrow cavities such as blood vessels. Their manufacturing precision directly impacts the safety and effectiveness of interventional procedures. During microcatheter production, the shaping process is crucial, requiring precise control of the temperature field and airflow to ensure the microcatheter material reaches its predetermined shape and solidifies stably.

[0003] Currently, most existing microcatheter shaping devices employ either single hot air or single hot steam shaping methods. Single hot air shaping uses heated air to generate hot air for heating and shaping the microcatheter; however, this method can easily lead to excessively rapid drying of the microcatheter surface. If temperature control is improper, stress concentration and deformation can easily occur, potentially damaging the microcatheter in severe cases. Single hot steam shaping typically uses saturated steam, whose temperature is fixed and difficult to precisely adjust, resulting in longer heating times and lower shaping efficiency. Furthermore, the dimensional stability of the shaped microcatheter is poor; even slight stress can damage the already shaped microcatheter, affecting product quality.

[0004] There is an urgent need for a microcatheter shaping device and control method to combine the advantages of hot air and hot steam and achieve synergistic control of the microcatheter shaping quality. Summary of the Invention

[0005] In order to at least solve one or more of the technical problems mentioned above, this application proposes a microcatheter shaping device and control method in several aspects.

[0006] In a first aspect, this application provides a microcatheter shaping device, comprising: a hot air output module for generating and outputting hot air with controllable temperature and flow rate; a hot steam output module for generating and outputting hot steam with controllable temperature and flow rate; a mixing chamber connected to the hot air output module and the hot steam output module respectively, for receiving hot air and hot steam and mixing them to form a gas-steam mixture, which is then output to the microcatheter placement area; and a control unit connected to the hot air output module and the hot steam output module respectively, for coordinating and controlling the output parameters of the hot air and hot steam to achieve coordinated shaping of the hot air and hot steam.

[0007] In some embodiments, the hot air output module includes: a hot air chamber communicating with the mixing chamber and having a first heating element disposed therein; an air intake motor disposed at the inlet of the hot air chamber and communicating with the hot air chamber; and a first temperature sensor and a first flow sensor disposed at the air outlet of the hot air chamber, which are respectively used to detect the temperature and flow rate of the hot air in real time and feed back the detection signals to the control unit; the control unit adjusts the heating power of the first heating element using a PID control algorithm based on the feedback signal from the first temperature sensor; and adjusts the air intake speed of the air intake motor using a PID control algorithm based on the feedback signal from the first flow sensor.

[0008] In some embodiments, the hot steam output module includes: a steam chamber communicating with the mixing chamber and having a second heating element disposed therein; a water tank for storing water; a water pump motor having its inlet connected to the water tank and its outlet connected to the inlet of the steam chamber; a second temperature sensor and a second flow sensor, both disposed at the outlet of the steam chamber, and used to detect the temperature and flow rate of the hot steam in real time, respectively, and to feed the detection signals back to the control unit; the control unit adjusts the heating power of the second heating element using a PID control algorithm based on the feedback signal from the second temperature sensor; and adjusts the speed of the water pump motor using a PID control algorithm based on the feedback signal from the second flow sensor.

[0009] In some embodiments, the system further includes a third temperature sensor and a third flow sensor, both disposed at the output end of the mixing chamber, for detecting the temperature and flow rate of the mixed gas-vapor mixture; the control unit corrects the output parameters based on the detection signals from the third temperature sensor and the third flow sensor, combined with a preset time function.

[0010] In some embodiments, the control unit integrates a calibration database, which stores shaping process parameters corresponding to different models of microcatheters. The shaping process parameters include at least temperature setpoints, flow rate setpoints, and time setpoints.

[0011] In some embodiments, the control unit further includes a time alarm module, which is used to automatically shut down the hot air output module and switch to only the hot steam output module when the setting time reaches a preset temperature-time threshold, and trigger an alarm prompt at the same time.

[0012] In some embodiments, the control unit is configured to: simultaneously activate the hot air output module and the hot steam output module during a first time period according to a preset time-segmented control strategy, so as to output a mixture of hot air and hot steam; after the first time period ends and a second time period begins, the control unit shuts down the hot air output module and keeps the hot steam output module working so as to output only hot steam.

[0013] In some embodiments, the hot air temperature setpoint during the first time period is higher than the hot steam temperature setpoint during the second time period.

[0014] In some embodiments, the control unit is further configured with a temperature-time curve generation module for generating a temperature setting curve that changes over time based on the model information of the microcatheter; the control unit dynamically adjusts the output temperature of the hot air output module and / or the hot steam output module according to the temperature setting curve.

[0015] In some embodiments, the mixing chamber is provided with spiral stirring blades, which rotate under the action of the driving component to stir and mix the hot air and hot steam entering the mixing chamber, forming a rotating airflow to achieve uniform mixing of hot air and hot steam.

[0016] In some embodiments, an emergency protection module is also included, which includes an emergency controller, a relay, and an electromagnetic shut-off valve installed on the pipe between the air outlet of the hot air output module and the mixing chamber. The emergency controller is signal-connected to the temperature sensor and control unit of the hot air output module and is used to monitor the hot air temperature and the working status of the control circuit in real time. When the hot air temperature exceeds a preset alarm threshold or the control circuit malfunctions, the emergency controller controls the relay to cut off the power supply to the first heating element of the hot air output module and the power supply to the air intake motor, and simultaneously closes the electromagnetic shut-off valve to cut off the hot air delivery channel.

[0017] In a second aspect, this application provides a microcatheter shaping control method applied to the aforementioned microcatheter shaping device, comprising the following steps: receiving microcatheter model information and target shaping parameters; retrieving corresponding shaping process parameters from a calibration database based on the model information; controlling the hot air output module and the hot steam output module to output hot air and hot steam at preset temperatures and preset flow rates respectively; mixing the hot air and hot steam in a mixing chamber and then delivering them to the microcatheter placement area for shaping; real-time detection of the hot air temperature, hot steam temperature, and temperature after mixing, and performing PID closed-loop control based on the detection signal and a preset time function to correct the output parameters; when the hot air temperature is detected to be too high or to reach the shaping time threshold, executing an emergency protection action, cutting off the hot air output and issuing an alarm.

[0018] In some embodiments, the temperature after mixing is detected in real time, and PID closed-loop control is performed based on the detection signal and a preset time function to correct the output parameters. This includes: the control unit acquiring the real-time detection signals from the mixing outlet temperature sensor and the mixing outlet flow sensor, and recording the duration since the start of the shaping process; the control unit determining the temperature difference compensation value between the estimated temperature of the microcatheter placement area at the current moment and the temperature detected by the mixing outlet temperature sensor based on the preset time function; and the control unit dynamically adjusting the output parameters of the hot air output module and / or the hot steam output module based on the temperature difference compensation value to make the actual temperature of the microcatheter placement area approach the target shaping temperature.

[0019] Using the microcatheter shaping device provided above, this embodiment of the application uses a control unit to issue control commands, causing hot air and hot steam to mix uniformly in the mixing chamber, thereby generating a shaping medium that combines temperature uniformity and humidity stability. This mixing method effectively overcomes the stress concentration and deformation problems easily caused by single hot air shaping, as well as the difficulties in temperature control and poor dimensional stability after shaping caused by single hot steam shaping. The shape retention performance of the shaped microcatheter is significantly improved, and the protection effect on the hydrophilic coating is enhanced, while damage to the surface coating is greatly reduced. Furthermore, the control unit can precisely adjust the output parameters of hot air and hot steam according to the process requirements of different microcatheters, achieving personalized and precise collaborative shaping of various types of microcatheters, significantly improving the shaping quality and finished product yield of the microcatheters. Attached Figure Description

[0020] The above and other objects, features, and advantages of exemplary embodiments of this application will become readily understood by reading the following detailed description with reference to the accompanying drawings. In the drawings, several embodiments of this application are illustrated by way of example and not limitation, and the same or corresponding reference numerals denote the same or corresponding parts, wherein:

[0021] Figure 1 A microcatheter shaping device according to an embodiment of this application is shown; Figure 2 A data flow diagram of an embodiment of this application is shown.

[0022] In the diagram: 100, microcatheter shaping device; 101. Hot air output module; 1011. Hot air chamber; 1012. Air intake motor; 1013. First temperature sensor; 1014. First flow sensor; 102. Hot steam output module; 1021. Steam chamber; 1022. Water pump motor; 1023. Water tank; 1024. Second temperature sensor; 1025. Second flow sensor; 103. Mixing chamber; 1031. Third temperature sensor; 1032. Third flow sensor. Detailed Implementation

[0023] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this application. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0024] It should be understood that the terms "comprising" and "including" used in the specification and claims of this application indicate the presence of the described features, integrals, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, integrals, steps, operations, elements, components and / or collections thereof.

[0025] It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the application. As used in this specification and claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used in this specification and claims refers to any combination and all possible combinations of one or more of the associated listed items, and includes such combinations.

[0026] As used in this specification and claims, the term "if" may be interpreted, depending on the context, as "when," "once," "in response to determination," or "in response to detection." Similarly, the phrase "if determined" or "if [described condition or event] is detected" may be interpreted, depending on the context, as "once determined," "in response to determination," "once [described condition or event] is detected," or "in response to detection of [described condition or event]."

[0027] The specific embodiments of this application will now be described in detail with reference to the accompanying drawings.

[0028] like Figure 1As shown, in some embodiments, this application provides a microcatheter shaping device 100, including: a hot air output module 101, which generates and outputs hot air with controllable temperature and flow rate; a hot steam output module 102, which generates and outputs hot steam with controllable temperature and flow rate; a mixing chamber 103, which is connected to the hot air output module 101 and the hot steam output module 102 respectively, for receiving hot air and hot steam and mixing them to form a gas-steam mixture, which is then output to the microcatheter placement area; and a control unit, which is signal-connected to the hot air output module 101 and the hot steam output module 102 respectively, for coordinating and controlling the output parameters of hot air and hot steam to achieve coordinated shaping of hot air and hot steam.

[0029] In this application, the microcatheter shaping device 100 includes a hot air output module 101, a hot steam output module 102, a mixing chamber 103, and a control unit. The hot air output module 101 generates and outputs hot air with controllable temperature and flow rate, while the hot steam output module 102 generates and outputs hot steam with controllable temperature and flow rate. The mixing chamber 103 is connected to both the hot air output module 101 and the hot steam output module 102, receiving the hot air from the hot air output module 101 and the hot steam from the hot steam output module 102, mixing the hot air and hot steam to form a uniform gas-vapor mixture, and then outputting it to the microcatheter placement area for shaping the microcatheter. The control unit is signal-connected to both the hot air output module 101 and the hot steam output module 102, coordinating and controlling the hot air parameters output by the hot air output module 101 and the hot steam parameters output by the hot steam output module 102, thereby achieving coordinated control of the hot air and hot steam to complete the coordinated shaping of the microcatheter.

[0030] Those skilled in the art will understand that hot air can rapidly raise the temperature, helping the microcatheter to quickly reach the shaping temperature and improve the shaping efficiency; while hot steam provides a mild and humid environment, which can prevent high-temperature hot air from causing thermal damage to the hydrophilic coating on the surface of the microcatheter, thereby protecting the integrity of the coating while ensuring the shaping effect.

[0031] The solution in this application uses a control unit to issue commands that uniformly mix hot air and hot steam within the mixing chamber 103, forming a shaping medium with uniform and stable temperature and humidity. This shaping medium effectively avoids the problems of stress concentration and deformation that easily occur with single-hot-air shaping, and the difficulty in accurately controlling the temperature and poor dimensional stability of single-hot-steam shaping, thus improving shaping efficiency and product quality. Furthermore, the control unit can precisely adjust the output parameters of hot air and hot steam according to the process requirements of different microcatheters, achieving personalized and precise collaborative shaping, significantly improving the shaping quality and finished product qualification rate of the microcatheters.

[0032] In one specific implementation, the hot air output module 101 includes: a hot air chamber 1011, which is connected to the mixing chamber 103 and has a first heating element disposed therein; an air intake motor 1012, which is disposed at the inlet of the hot air chamber 1011 and connected to the hot air chamber 1011; and a first temperature sensor 1013 and a first flow sensor 1014, which are disposed at the air outlet of the hot air chamber 1011 and are used to detect the temperature and flow rate of the hot air in real time, and feed the detection signals back to the control unit; the control unit adjusts the heating power of the first heating element using a PID (Proportion Integral Differential) control algorithm based on the feedback signal of the first temperature sensor 1013; and adjusts the air intake speed of the air intake motor 1012 using a PID control algorithm based on the feedback signal of the first flow sensor 1014.

[0033] In this application, the hot air output module 101 includes a hot air chamber 1011, an intake motor 1012, a first temperature sensor 1013, and a first flow sensor 1014. The hot air chamber 1011 is connected to the mixing chamber 103 and contains a first heating element to heat the air entering the hot air chamber 1011 to form hot air. The intake motor 1012 is located at the inlet of the hot air chamber 1011 and is connected to it. Under the control of the control unit, it blows air into the hot air chamber 1011, and the airflow can be controlled by adjusting its rotation speed. The first temperature sensor 1013 and the first flow sensor 1014 are both located at the outlet of the hot air chamber 1011, specifically on the pipe connecting the hot air chamber 1011 and the mixing chamber 103. They are used to detect the temperature and flow rate of the hot air in real time and feed the detected signals back to the control unit in real time.

[0034] After receiving the feedback signal from the first temperature sensor 1013, the control unit compares the measured temperature value with a preset target temperature value (based on a given value), calculates the error using a PID control algorithm, and then dynamically adjusts the heating power of the first heating element based on the calculation result. This achieves precise closed-loop control of the hot air temperature, ensuring that the hot air temperature remains stable within the preset range and preventing temperature fluctuations from affecting the shaping effect of the microduct. Simultaneously, based on the feedback signal from the first flow sensor 1014, the control unit compares the measured flow rate value with a preset target flow rate value and adjusts the speed of the intake motor 1012 using a PID control algorithm. This precisely controls the intake air velocity and hot air flow rate to adapt to the differentiated airflow requirements of microducts of different specifications.

[0035] This application's solution achieves precise control of hot air temperature by setting up a hot air chamber 1011 and its internal first heating element, combined with real-time feedback from the first temperature sensor 1013 and PID adjustment of the control unit. This ensures that the hot air can be quickly and stably maintained within the preset temperature range, avoiding stress concentration, deformation, or even thermal damage to the microducts caused by excessive temperature or fluctuations, significantly improving the temperature stability of the setting process. Furthermore, by setting up an inlet motor 1012 and utilizing feedback signals from the first flow sensor 1014 and PID adjustment of the control unit to dynamically adjust the speed of the inlet motor 1012, the beneficial effect of precisely controlling the hot air output flow rate is achieved. This allows the device to flexibly adjust the airflow according to the process requirements of microducts of different specifications, ensuring that the heat exchange efficiency and airflow impact force are at their optimal state during the setting process. This solution guarantees the reliability of the microduct-assisted setting process and the consistency of the final product's quality, effectively overcoming the problems of uncontrollable temperature, difficult airflow adjustment, and excessively rapid surface drying in existing single hot air setting processes.

[0036] In one specific implementation, the hot steam output module 102 includes: a steam chamber 1021, which is connected to the mixing chamber 103 and has a second heating element disposed therein; a water tank 1023 for storing water; a water pump motor 1022, the inlet of which is connected to the water tank 1023 and the outlet of which is connected to the inlet of the steam chamber 1021; a second temperature sensor 1024 and a second flow sensor 1025, which are disposed at the outlet of the steam chamber 1021 and are used to detect the temperature and flow rate of the hot steam in real time, and feed the detection signals back to the control unit; the control unit adjusts the heating power of the second heating element using a PID control algorithm based on the feedback signal of the second temperature sensor 1024; and adjusts the speed of the water pump motor 1022 using a PID control algorithm based on the feedback signal of the second flow sensor 1025.

[0037] In this application, the hot steam output module 102 includes a steam chamber 1021, a water tank 1023, a water pump motor 1022, a second temperature sensor 1024, and a second flow sensor 1025. The steam chamber 1021 is connected to the mixing chamber 103 and contains a second heating element for heating the water entering the steam chamber 1021 to generate hot steam. The water tank 1023 stores water at room temperature, providing a water source for steam generation. The inlet of the water pump motor 1022 is connected to the water tank 1023, and its outlet is connected to the inlet of the steam chamber 1021. Under the control of the control unit, it pumps water from the water tank 1023 into the steam chamber 1021, and the water flow rate and steam generation rate can be controlled by adjusting the motor speed. The second temperature sensor 1024 and the second flow sensor 1025 are both located at the outlet of the steam chamber 1021, and are used to detect the temperature and flow rate of the hot steam in real time, respectively, and feed the detected signals back to the control unit in real time.

[0038] After receiving the feedback signal from the second temperature sensor 1024, the control unit compares the measured temperature value with the preset target steam temperature value and calculates the error using a PID control algorithm. Based on the calculation result, it dynamically adjusts the heating power of the second heating element to achieve precise closed-loop control of the hot steam temperature. This ensures the hot steam temperature remains stable within the preset range, preventing temperature fluctuations from affecting the shaping effect of the microconduit or damaging the hydrophilic coating. Simultaneously, based on the feedback signal from the second flow sensor 1025, the control unit compares the measured steam flow rate with the preset target flow rate value and uses a PID control algorithm to adjust the speed of the water pump motor 1022. This precisely controls the amount of water entering the steam chamber 1021, thereby adjusting the steam generation rate and output flow rate to meet the varying steam flow requirements of different sized microconduits.

[0039] The solution proposed in this application incorporates both temperature and flow rate into closed-loop control, enabling the hot steam output module 102 to respond to control commands independently and accurately. This provides a stable and controllable steam source for subsequent co-mixing with hot air in the mixing chamber 103, thereby ensuring the reliability of the micro-conduit co-forming process and the quality stability of the final product. It effectively overcomes the problems of uncontrollable temperature, difficult flow rate adjustment, and poor dimensional stability after forming in existing single hot steam forming processes.

[0040] In one specific implementation, it further includes: a third temperature sensor 1031 and a third flow sensor 1032, both disposed at the output end of the mixing chamber 103, for detecting the temperature and flow rate of the mixed gas-vapor mixture; the control unit corrects the output parameters based on the detection signals of the third temperature sensor 1031 and the third flow sensor 1032, combined with a preset time function.

[0041] In this application, the microcatheter shaping device 100 further includes a third temperature sensor 1031 and a third flow sensor 1032, both of which are located at the output end of the mixing chamber 103. These sensors are used to detect in real time the temperature and flow rate of the gas-vapor mixture formed after the hot air and hot steam are mixed within the mixing chamber 103 during actual output. The control unit is signal-connected to the third temperature sensor 1031 and the third flow sensor 1032, receives the detected temperature and flow signals, and dynamically corrects the output parameters based on these detected signals and a preset time function.

[0042] Those skilled in the art will understand that during the microcatheter shaping process, there is usually a certain difference between the temperature collected by the sensor at the outlet of the mixing chamber 103 and the actual temperature of the microcatheter placement area. This difference is mainly due to two factors: First, because there is a certain spatial distance between the outlet of the mixing chamber 103 and the microcatheter placement area, the gas-vapor mixture will experience temperature attenuation due to heat dissipation during transmission, resulting in the actual temperature of the placement area being lower than the outlet detection value. Second, under actual operating conditions, the microcatheter placement area will accumulate heat due to continuous heat input, and even if the control system remains stable, the temperature in this area may slowly rise over time. If control is based solely on the temperature at the outlet of the mixing chamber 103, the controller may mistakenly assume that the outlet temperature has not met the requirements when the placement area temperature has not yet reached the set value or has exceeded the set value, thus affecting the shaping effect.

[0043] To address this issue, this solution introduces a time function to correct the detected values: A time function model is established by pre-testing the time required for the gas-vapor mixture to travel from the outlet of the mixing chamber 103 to the microcatheter placement area under different flow rates and temperatures. Based on real-time data from the third temperature sensor 1031 and the third flow sensor 1032, the control unit uses this time function to calculate the actual temperature of the microcatheter placement area and compares it with a preset target temperature. Then, using a PID control algorithm, the output parameters of the hot air output module 101 and the hot steam output module 102 are adjusted in reverse until the temperature of the microcatheter placement area stabilizes within the preset range.

[0044] The solution proposed in this application achieves real-time monitoring of the actual output state of the mixed gas-vapor mixture by setting a third temperature sensor 1031 and a third flow sensor 1032, providing an accurate data basis for subsequent parameter correction and avoiding process runaway caused by unknown output state.

[0045] In addition, the solution of this application corrects the output parameters by the control unit based on the detection signals of the third temperature sensor 1031 and the third flow sensor 1032, combined with a preset time function. This effectively compensates for the temperature difference between the outlet of the mixing chamber 103 and the microcatheter placement area, solves the problem of deviation between the actual shaping temperature and the set value caused by heat loss during airflow transmission, ensures that the process temperature of the microcatheter placement area is highly consistent with the preset target, and significantly improves the accuracy of the shaping process and product consistency.

[0046] In one specific implementation, the control unit integrates a calibration database that stores shaping process parameters corresponding to different models of microcatheters. The shaping process parameters include at least temperature setpoints, flow rate setpoints, and time setpoints.

[0047] In this application, the control unit integrates a calibration database that stores the shaping process parameters for different models of microcatheters. Specifically, the shaping process parameters include at least temperature setpoints, flow rate setpoints, and time setpoints. Because microcatheters from different manufacturers and of different models differ in material properties, coating types, geometric dimensions, and target shaping angles, their requirements for the required hot air temperature, flow rate, and action time during the shaping process also vary. By conducting pre-process experiments on each model of microcatheter, the optimal combination of shaping parameters is obtained and stored in the calibration database. When shaping a specific model of microcatheter is required, the operator only needs to input or select the corresponding model information, and the control unit can automatically retrieve the corresponding process parameters from the calibration database and precisely control the hot air output module 101 and the hot steam output module 102 based on these parameters.

[0048] This solution, through the aforementioned structure, enables rapid and precise adaptation to different models of microcatheters, avoiding shaping defects caused by improper manual parameter settings, and significantly improving the intelligence level, ease of operation, and consistency and repeatability of the shaping process of the equipment.

[0049] In one specific implementation, the control unit further includes a time alarm module, which is used to automatically shut down the hot air output module 101 and switch to only the hot steam output module 102 when the setting time reaches a preset temperature-time threshold, and at the same time trigger an alarm prompt.

[0050] In this application, the control unit also integrates a time alarm module. This module monitors the hot air exposure time to protect the hydrophilic coating on the microcatheter surface from damage caused by prolonged hot air erosion. Specifically, the time alarm module has preset temperature-time thresholds for different setting temperatures. These thresholds are calibrated based on experimental data of different types of microcatheters' tolerance to hot air exposure at different temperatures and are stored in a calibration database. When the microcatheter setting process is started, the control unit records the working time of the hot air output module 101 in real time and compares the current setting temperature with the corresponding temperature-time threshold.

[0051] When the setting time reaches the preset temperature-time threshold, the time alarm module determines that the potential risk of damage to the microduct coating by hot air has increased, and then automatically triggers protective actions: First, the control unit sends a shutdown command to the hot air output module 101 to cut off the hot air output; at the same time, the control unit keeps the hot steam output module 102 working, so that the device switches to setting only by hot steam, using the mild characteristics of hot steam to keep the microduct warm and set, avoiding coating cracking, increased roughness or performance degradation caused by prolonged hot air action; in addition, the time alarm module triggers an alarm prompt at the same time to inform the operator that the process has entered the stage where hot air is turned off and only steam is working. This alarm prompt is usually a prompt audible and visual signal that is different from a fault alarm.

[0052] It is worth noting that the preset temperature-time threshold in this solution does not refer to a single timing duration, but rather to the maximum allowable duration of continuous hot air action at a specific setting temperature. Specifically, after the microcatheter setting process is started, the control unit monitors the operating status of the hot air output module 101 in real time and records the duration of the current setting temperature. Once the duration at a certain temperature is detected to have reached the preset threshold corresponding to that temperature, the time alarm module immediately triggers an alarm to inform the operator that the current hot air action time has reached the critical value.

[0053] The time alarm module provided in this application realizes intelligent segmented control of the shaping process. It fully utilizes the advantage of rapid shaping in the early stage of hot air, and avoids the overuse of hot air by limiting the time threshold. Thus, while ensuring the shaping effect of the micro-duct, it maximizes the protection of the integrity of the hydrophilic coating and significantly improves the shaping quality and yield of the product.

[0054] In some embodiments of this application, the control unit also supports a flexible time-segmented control strategy. Multiple time-segmented control modes can be preset within the control unit to suit the material properties and coating tolerances of different types of microcatheters.

[0055] For example, in a typical rapid shaping mode, the control unit is configured to simultaneously activate the hot air output module and the hot steam output module within the first 10 seconds after shaping begins (the first time period). This allows the hot air and hot steam to be uniformly mixed in the mixing chamber before being output to the microcatheter placement area. During this stage, the hot air temperature is set to 120℃~150℃, and the hot steam temperature is set to 100℃~110℃. The efficient heat transfer capability of the hot air enables the microcatheter to quickly reach the shaping temperature, while the hot steam provides a humid environment to prevent surface drying and cracking.

[0056] After the first 10 seconds, the control unit automatically shuts off the hot air output module, leaving only the hot steam output module running for 10-20 seconds (the second time period). During this stage, only pure hot steam is output, and the temperature can drop to 80℃-100℃. The pure hot steam stage is used to gently shape and maintain the humidity of the molded microducts, further releasing internal stress, protecting the hydrophilic coating, and preventing coating aging or embrittlement caused by continuous hot air action.

[0057] In another optional implementation, the control unit can also dynamically adjust the duration ratio and temperature difference between the two time periods according to the different microcatheter models. For example, for microcatheters with thicker coatings, the time of the pure hot steam stage can be appropriately extended and the steam temperature reduced; for thin-walled microcatheters that require rapid shaping, the mixing stage time can be shortened and the hot air temperature increased.

[0058] In addition, the control unit also supports temperature-time curve control mode. Operators can input or select a temperature-time curve (such as linear heating, stepped heating, heat preservation platform, etc.), and the control unit adjusts the heating power of the hot air output module and hot steam output module in real time according to the curve to achieve precise temperature control curve tracking and meet the requirements of complex shaping processes.

[0059] In one specific implementation, the mixing chamber 103 is provided with a spiral stirring blade. The spiral stirring blade rotates under the action of the driving component to stir and mix the hot air and hot steam entering the mixing chamber 103, forming a rotating airflow to achieve uniform mixing of hot air and hot steam.

[0060] In this application, a spiral stirring blade (not shown in the figure) is provided inside the mixing chamber 103. The spiral stirring blade is fixedly installed in the mixing chamber 103 and extends spirally along the airflow direction. When the hot air output from the hot air output module 101 and the hot steam output from the hot steam output module 102 enter the mixing chamber 103 through pipes, the two airflows are forced to rotate and advance along the inner wall of the chamber under the guidance of the spiral stirring blade, forming a rotating airflow. During the rotation, the hot air and hot steam shear and mix with each other, thereby achieving uniform mixing and forming a gas-vapor mixture with a consistent temperature and humidity field distribution.

[0061] In one specific implementation, an emergency protection module is also included. The emergency protection module includes an emergency controller, a relay, and an electromagnetic shut-off valve installed on the pipe between the air outlet of the hot air output module 101 and the mixing chamber 103. The emergency controller is signal-connected to the temperature sensor and control unit of the hot air output module 101 and is used to monitor the hot air temperature and the working status of the control circuit in real time. When the hot air temperature exceeds a preset alarm threshold or the control circuit malfunctions, the emergency controller controls the relay to cut off the power supply to the first heating element of the hot air output module 101 and the drive power supply to the air intake motor 1012, and simultaneously closes the electromagnetic shut-off valve to cut off the hot air delivery channel.

[0062] In this application, the microcatheter shaping device 100 also includes an emergency protection module, which provides reliable safety protection in case of abnormal hot air output or control unit failure. Specifically, the emergency protection module includes an emergency controller, a relay, and an electromagnetic shut-off valve. The electromagnetic shut-off valve is installed on the connecting pipe between the air outlet of the hot air output module 101 and the mixing chamber 103, and is used to physically block the hot air delivery channel in an emergency. The emergency controller is connected to the temperature sensor and control unit signal in the hot air output module 101, respectively, to monitor the hot air temperature output by the hot air output module 101 and the operating status of the control unit in real time.

[0063] Under normal operating conditions, the emergency controller is in a standby monitoring state. When the emergency controller detects that the hot air temperature exceeds the preset alarm threshold through the temperature sensor of the hot air output module 101, it determines that the system is in an over-temperature abnormal state; or, when the emergency controller detects a fault in the control unit, such as a control unit crash, voltage runaway, abnormal signal, or failure to output a normal heartbeat signal for a long time, it determines that the control unit has failed. When any of the above abnormal situations occur, the emergency controller immediately triggers a protection action: on the one hand, the emergency controller sends a control signal to the relay, which performs a cut-off action to quickly disconnect the power supply to the first heating element in the hot air output module 101 and the drive power supply to the air intake motor 1012, stopping the generation of hot air from the source; on the other hand, the emergency controller simultaneously sends a closing signal to the electromagnetic shut-off valve, which quickly closes, physically cutting off the airflow channel between the hot air output module 101 and the mixing chamber 103, preventing any residual hot air from entering the mixing chamber 103 and the subsequent micro-conduit placement area.

[0064] The emergency protection module provided in this solution is a hardware safety redundancy system independent of the control unit. It can independently, quickly and reliably cut off the hot air source when the main control system fails or the hot air temperature runs out of control. It achieves dual protection of logical power failure and physical gas cutoff, effectively preventing irreversible thermal damage to the microconductor caused by overheated hot air. At the same time, it avoids more serious safety accidents caused by continuous abnormal operation of the equipment, and significantly improves the overall safety and reliability of the device.

[0065] In one specific implementation, it further includes: a barometer, which is signal-connected to the control unit for measuring the ambient air pressure; the control unit compensates the output parameters of the hot air output module 101 and / or the hot steam output module 102 according to the detection signal of the barometer, so that the temperature and flow rate of the gas-vapor mixture output to the microduct placement area remain stable under different air pressure conditions.

[0066] In this application, the microcatheter shaping device 100 also includes a barometer, which is signal-connected to the control unit and used to measure the ambient air pressure of the environment in which the device is used in real time. Since the ambient air pressure varies at different altitudes or in different seasons and weather conditions within the same region, and changes in air pressure directly affect the density, heat capacity, and heat exchange efficiency of the gas, this influences the airflow characteristics output by the hot air output module 101 and the hot steam output module 102. Consequently, even with the same control parameters, the actual temperature and flow rate of the gas-vapor mixture output to the microcatheter placement area may deviate, thus affecting the stability and consistency of the shaping effect.

[0067] To address the aforementioned issues, this solution employs a barometer to collect ambient air pressure data in real time and feeds the detection signal back to the control unit. The control unit has a pre-set air pressure compensation algorithm or compensation coefficient table. Based on the received actual air pressure value, it automatically and dynamically adjusts the output parameters of the hot air output module 101 and / or the hot steam output module 102. Specifically, when a low ambient air pressure is detected, the control unit can adjust parameters such as the heating power of the first heating element, the speed of the intake motor 1012, the heating power of the second heating element, or the speed of the water pump motor 1022 to ensure that the gas-vapor mixture ultimately output to the microduct placement area remains stably maintained within the preset target temperature and flow rate range under different air pressure conditions.

[0068] Through the above structure, this solution effectively eliminates the interference of environmental air pressure changes on the microcatheter shaping process, enabling the device to adapt to the usage requirements of different altitude regions and complex climatic conditions, and significantly improving the environmental adaptability and process stability of the equipment.

[0069] It is worth noting that this application does not specify the number of controllers in the control unit. In practical applications, the control unit may only have one main controller, which uniformly receives feedback signals from each temperature sensor and flow sensor, centrally processes the data and performs PID calculations, and issues control commands to the relevant actuators of the hot air output module 101, the hot steam output module 102, and the mixing chamber 103 to achieve overall coordinated control. As another optional implementation, such as Figure 2 As shown, the control unit can also be configured as three independent controllers, respectively used to control the gas-steam mixture output from the hot air output module 101, the hot steam output module 102, and the mixing chamber 103. Specifically, the first controller is dedicated to adjusting the heating power of the hot air output module 101 and the speed of the intake motor 1012 based on feedback signals from the first temperature sensor 1013 and the first flow sensor 1014; the second controller is dedicated to adjusting the heating power of the hot steam output module 102 and the speed of the water pump motor 1022 based on feedback signals from the second temperature sensor 1024 and the second flow sensor 1025; and the third controller is used to perform correction calculations based on feedback signals from the third temperature sensor 1031 and the third flow sensor 1032 located at the outlet of the mixing chamber 103, combined with a preset time function, and sends coordinated control commands to the first and second controllers to achieve precise adjustment of the final output gas-steam mixture. Through this flexible control architecture, this application can select the most suitable controller configuration scheme according to the actual control accuracy requirements and system complexity, simplifying the data processing burden of a single main controller and improving the system's response speed and control reliability through multi-controller collaboration.

[0070] In some embodiments, this application provides a microcatheter shaping control method applied to the aforementioned microcatheter shaping device 100, comprising the following steps: receiving microcatheter model information and target shaping parameters; retrieving corresponding shaping process parameters from a calibration database based on the model information; controlling the hot air output module 101 and the hot steam output module 102 to output hot air and hot steam at preset temperatures and preset flow rates respectively; mixing the hot air and hot steam in the mixing chamber 103 and then delivering them to the microcatheter placement area for shaping; real-time detection of the hot air temperature, hot steam temperature, and temperature after mixing, and performing PID closed-loop control based on the detection signal and a preset time function to correct the output parameters; when the hot air temperature is detected to be too high or the shaping time threshold is reached, an emergency protection action is executed, cutting off the hot air output and issuing an alarm.

[0071] In this application, the microcatheter shaping control method is applied to the aforementioned microcatheter shaping device 100, achieving efficient, precise, and safe shaping of the microcatheter through an intelligent control process. The method includes the following steps: First, the control unit receives the microcatheter model information and the target calibration parameters set by the user, which may include basic target values ​​such as the expected calibration temperature and flow rate. After receiving the above information, the control unit automatically retrieves the calibration process parameters corresponding to the microcatheter model from the internally integrated calibration database. These process parameters are the optimal values ​​obtained from previous experimental optimizations and include at least the temperature setpoint, flow rate setpoint, and time setpoint.

[0072] Subsequently, based on the retrieved shaping process parameters, the control unit sends control commands to the hot air output module 101 and the hot steam output module 102, respectively. The control unit controls the hot air output module 101 to generate and output hot air at a preset temperature and flow rate, and simultaneously controls the hot steam output module 102 to generate and output hot steam at a preset temperature and flow rate. The hot air and hot steam enter the mixing chamber 103 through pipes, where they are thoroughly mixed to form a gas-vapor mixture with a uniformly distributed temperature and humidity field. This gas-vapor mixture is then transported to the microcatheter placement area for shaping of the microcatheter placed therein.

[0073] During the finalization process, the temperatures of the hot air output from the hot air output module 101, the hot steam output from the hot steam output module 102, and the temperature of the gas-steam mixture after mixing at the output of the mixing chamber 103 are monitored in real time, and these monitoring signals are fed back to the control unit in real time. Based on these feedback signals and a preset time function, the control unit performs PID closed-loop control to dynamically correct the output parameters of the hot air output module 101 and the hot steam output module 102, compensating for the temperature difference between the outlet of the mixing chamber 103 and the microcatheter placement area, ensuring that the actual process temperature in the microcatheter placement area remains stable within the preset range.

[0074] In addition, the system simultaneously performs safety monitoring and process optimization control throughout the entire finalization process. When the hot air temperature exceeds the preset alarm threshold, or a control circuit malfunction is detected, the system immediately triggers emergency protection actions, executes emergency protection procedures, quickly cuts off the power supply to the heating wire of the hot air output module 101 and the drive power supply to the air intake motor 1012, and simultaneously closes the electromagnetic shut-off valve installed on the pipeline to physically block the hot air delivery channel. At the same time, a fault alarm signal is issued to prompt the operator to handle the situation. On the other hand, when the finalization time reaches the preset temperature-time threshold, the system automatically performs process switching, shuts down the hot air output module 101 and switches to only the hot steam output module 102 to continue working. At the same time, a status alarm is issued to inform the operator that the coating protection stage, in which hot air is shut off and only steam is working, has been entered.

[0075] This application achieves intelligent control of the entire process, from parameter retrieval and collaborative output to precise temperature control and safety protection, through the aforementioned control method, effectively improving the efficiency, quality and safety of microcatheter shaping.

[0076] In one specific implementation, the temperature after mixing is detected in real time, and PID closed-loop control is performed based on the detection signal and a preset time function to correct the output parameters. This includes: the control unit acquiring the real-time detection signals from the mixing outlet temperature sensor and the mixing outlet flow sensor, and recording the duration since the start of the shaping process; the control unit determining the temperature difference compensation value between the estimated temperature of the microcatheter placement area and the temperature detected by the mixing outlet temperature sensor at the current moment based on the preset time function; and the control unit dynamically adjusting the output parameters of the hot air output module 101 and / or the hot steam output module 102 based on the temperature difference compensation value, so that the actual temperature of the microcatheter placement area approaches the target shaping temperature.

[0077] In the scheme of this application, during the process of real-time detection of the mixed temperature and PID closed-loop control based on the detection signal and a preset time function to correct the output parameters, the control unit specifically performs the following steps: First, the control unit acquires the detection signals from the mixing outlet temperature sensor and the mixing outlet flow sensor located at the output end of the mixing chamber 103 in real time, and records the duration since the start of the shaping process. Because there is a spatial distance between the outlet of the mixing chamber 103 and the actual placement area of ​​the microcatheter, the gas-vapor mixture experiences temperature decay due to environmental heat dissipation during transmission. Simultaneously, the microcatheter placement area experiences heat accumulation under continuous heat input, resulting in a difference between the actual temperature in this area and the detected value at the outlet of the mixing chamber 103. This difference fluctuates regularly with time and flow rate changes.

[0078] To address the aforementioned issues, the control unit has a pre-defined time function calibrated based on experimental data. This time function describes the variation of the temperature difference between the detected temperature at the outlet of the mixing chamber 103 and the actual temperature in the microcatheter placement area under different flow conditions over time. Based on the duration of the current moment and the reading from the mixing outlet flow sensor, the control unit calls the corresponding time function to calculate and determine the temperature difference compensation value between the estimated temperature of the microcatheter placement area and the temperature detected by the mixing outlet temperature sensor at the current moment.

[0079] Subsequently, the control unit dynamically adjusts the output parameters of the hot air output module 101 and / or the hot steam output module 102 based on the temperature difference compensation value. Specifically, the control unit takes the estimated temperature of the microcatheter placement area as the actual controlled object, compares it with the preset target shaping temperature, and calculates the required adjustment amount through a PID control algorithm. Then, it adjusts the heating power of the first heating element, the speed of the air intake motor 1012, the heating power of the second heating element, or the speed of the water pump motor 1022 to ensure that the actual temperature of the microcatheter placement area continuously approaches and stabilizes within the target shaping temperature range.

[0080] Through the above steps, this application achieves indirect and precise control of the temperature in the microcatheter placement area, effectively compensating for temperature deviations caused by transmission distance and heat accumulation effects, ensuring that the microcatheter remains in the optimal process temperature environment throughout the entire shaping cycle, and significantly improving the accuracy of the shaping process and product consistency.

[0081] While numerous embodiments of this application have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Many modifications, alterations, and alternatives will arise for those skilled in the art without departing from the spirit and intent of this application. It should be understood that various alternatives to the embodiments of this application described herein may be employed in the practice of this application. The appended claims are intended to define the scope of protection of this application and therefore cover equivalents or alternatives within the scope of these claims.

Claims

1. A microcatheter shaping device, characterized in that, include: Hot air output module, which is used to generate and output hot air with controllable temperature and flow rate; A hot steam output module is used to generate and output hot steam with controllable temperature and flow rate; The mixing chamber is connected to the hot air output module and the hot steam output module respectively, and is used to receive hot air and hot steam and mix them to form a gas-vapor mixture, which is then output to the microcatheter placement area. as well as The control unit is connected to the hot air output module and the hot steam output module respectively, and is used to coordinate and control the output parameters of hot air and hot steam to achieve coordinated shaping of hot air and hot steam.

2. The microcatheter shaping device according to claim 1, characterized in that, The hot air output module includes: A hot air chamber, which is connected to the mixing chamber, and is equipped with a first heating element inside; An air intake motor is disposed at the inlet of the hot air chamber and communicates with the hot air chamber; and A first temperature sensor and a first flow sensor are disposed at the air outlet of the hot air chamber and are used to detect the temperature and flow rate of the hot air in real time, respectively, and feed the detection signals back to the control unit. The control unit adjusts the heating power of the first heating element using a PID control algorithm based on the feedback signal from the first temperature sensor; and adjusts the air intake speed of the air intake motor using a PID control algorithm based on the feedback signal from the first flow sensor.

3. The microcatheter shaping device according to claim 1, characterized in that, The hot steam output module includes: A steam chamber, which is connected to the mixing chamber, and a second heating element is provided inside; Water tanks are used to store water; The water pump motor has its inlet connected to the water tank and its outlet connected to the inlet of the steam chamber. The second temperature sensor and the second flow sensor are located at the outlet of the steam chamber and are used to detect the temperature and flow rate of the hot steam in real time, respectively, and feed the detection signals back to the control unit. The control unit adjusts the heating power of the second heating element using a PID control algorithm based on the feedback signal from the second temperature sensor; and adjusts the speed of the water pump motor using a PID control algorithm based on the feedback signal from the second flow sensor.

4. The microcatheter shaping device according to any one of claims 1-3, characterized in that, Also includes: The third temperature sensor and the third flow sensor are located at the output end of the mixing chamber and are used to detect the temperature and flow rate of the mixed gas-vapor mixture. The control unit is also connected to the output signal of the mixing chamber, and corrects the output parameters based on the detection signals of the third temperature sensor and the third flow sensor, combined with a preset time function.

5. The microcatheter shaping device according to claim 4, characterized in that, The control unit integrates a calibration database, which stores the shaping process parameters corresponding to different models of microcatheters. The shaping process parameters include at least temperature setpoints, flow rate setpoints, and time setpoints.

6. The microcatheter shaping device according to claim 5, characterized in that, The control unit also includes a time alarm module, which is used to automatically shut down the hot air output module and switch to only the hot steam output module when the setting time reaches a preset temperature-time threshold, and at the same time trigger an alarm prompt.

7. The microcatheter shaping device according to claim 1, characterized in that, The control unit is configured to: simultaneously activate the hot air output module and the hot steam output module during a first time period according to a preset time-segmented control strategy, so as to output a mixture of hot air and hot steam; after the first time period ends, in the second time period, the control unit shuts down the hot air output module and keeps the hot steam output module working, so as to output only hot steam.

8. The microcatheter shaping device according to claim 7, characterized in that, The hot air temperature setting value during the first time period is higher than the hot steam temperature setting value during the second time period.

9. The microcatheter shaping device according to claim 1, characterized in that, The control unit is also equipped with a temperature-time curve generation module, which is used to generate a temperature setting curve that changes over time based on the model information of the microcatheter; the control unit dynamically adjusts the output temperature of the hot air output module and / or the hot steam output module according to the temperature setting curve.

10. The microcatheter shaping device according to claim 1, characterized in that, The mixing chamber is equipped with spiral stirring blades, which rotate under the action of the driving component to stir and mix the hot air and hot steam entering the mixing chamber, forming a rotating airflow and achieving uniform mixing of hot air and hot steam.

11. The microcatheter shaping device according to claim 1, characterized in that, It also includes an emergency protection module, which includes an emergency controller, a relay, and an electromagnetic shut-off valve installed on the pipe between the air outlet of the hot air output module and the mixing chamber. The emergency controller is connected to the first temperature sensor of the hot air output module and the control unit for real-time monitoring of the hot air temperature and the working status of the control circuit. When the hot air temperature exceeds the preset alarm threshold or the control circuit malfunctions, the emergency controller controls the relay to cut off the power supply to the first heating element of the hot air output module and the power supply to the air intake motor, and simultaneously closes the electromagnetic shut-off valve to cut off the hot air delivery channel.

12. A microcatheter shaping control method, applied to the microcatheter shaping device according to any one of claims 1-11, characterized in that, Includes the following steps: Receive the model information and target design parameters of the microcatheter; Based on the model information, retrieve the corresponding finalization process parameters from the calibration database; The hot air output module and the hot steam output module are controlled to output hot air and hot steam at preset temperatures and preset flow rates, respectively. Hot air and hot steam are mixed in the mixing chamber and then delivered to the microcatheter placement area for shaping; The system monitors the hot air temperature, hot steam temperature, and mixed temperature in real time, and performs PID closed-loop control based on the detection signals and a preset time function to correct the output parameters. When the hot air temperature is detected to be too high or to reach the setting time threshold, an emergency protection action is executed, cutting off the hot air output and issuing an alarm.

13. The microcatheter shaping method according to claim 12, characterized in that, The system monitors the temperature after mixing in real time and performs PID closed-loop control based on the detected signal and a preset time function, correcting output parameters including: The control unit acquires the real-time detection signals from the mixed outlet temperature sensor and the mixed outlet flow sensor, and records the duration since the start of the design process; The control unit determines the temperature difference compensation value between the estimated temperature of the microcatheter placement area and the temperature detected by the mixing outlet temperature sensor at the current moment, based on a preset time function. The control unit dynamically adjusts the output parameters of the hot air output module and / or hot steam output module according to the temperature difference compensation value, so that the actual temperature of the microcatheter placement area approaches the target shaping temperature.

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