Preparation system of high-elasticity and high-strength artificial heart valve leaflet

Abstract

The preparation system of the high-elasticity and high-strength artificial heart valve leaflet comprises a yarn pretreatment unit, a weaving unit, a leaflet cutting unit, a valve forming unit and a process control unit, the yarn pretreatment unit pretreats spandex monofilaments to obtain first yarn; weaving the first yarns by a weaving unit to obtain first valve leaf gray cloth; a valve leaflet cutting unit cuts the first valve leaflet gray cloth into a preset first form to obtain second valve leaflet gray cloth; the valve leaflet forming unit carries out heat setting treatment on the second valve leaflet gray cloth to obtain a target valve leaflet; the process control unit is in communication connection with the knitting unit and controls the knitting process through a data driving mechanism. Flexible expansion and precise control, closed-loop control and real-time parameter correction in the weaving process are achieved, the consistency of the weaving precision and mechanical properties of the valve leaflet is guaranteed, yarn pretreatment and the forming process are coordinated, the high-elasticity and high-strength characteristics of the valve leaflet are enhanced, and precise forming and multi-model adaptation of the valve leaflet are achieved.

Description

Technical Field

[0001] The present invention relates to the field of measurement technology, and more specifically, to a system for preparing high-elasticity and high-strength artificial heart valve leaflets. Background Art

[0002] At present, artificial heart valves widely used in clinical practice are mainly divided into two categories: mechanical valves and biological valves.

[0003] Mechanical valves are typically constructed from metal alloys (such as cobalt-chromium alloys and carbon materials), offering advantages such as long service life and high structural stability, enabling long-term valve function in vivo. However, the metal-blood interface is not conducive to endothelialization, requiring lifelong anticoagulation therapy and increasing the risk of bleeding and thrombotic complications.

[0004] Bioprosthetic valves are primarily derived from xenogeneic animal pericardium (e.g., bovine or porcine) or autologous tissue, and possess excellent biocompatibility and low thrombogenicity. However, because natural tissue or biomimetic materials are susceptible to fatigue damage, calcification, or delamination under long-term, repeated deformation and high-shear blood flow, bioprosthetic valves generally suffer from insufficient mechanical strength and poor durability. Frequent replacement is particularly necessary in young patients, and consistent mass production is difficult, limiting their widespread application.

[0005] In addition, traditional valve manufacturing materials are difficult to simultaneously meet key performance requirements such as flexibility, durability, mechanical adaptability and individual controllability.

[0006] Therefore, the problems existing in the prior art need to be further improved and developed. Summary of the Invention

[0007] (1) Purpose of the invention: In order to solve the problems existing in the above-mentioned prior art, the purpose of the present invention is to provide a system for preparing high-elasticity and high-strength artificial heart valve leaflets.

[0008] (II) Technical Solution: In order to solve the above technical problems, this technical solution provides a system for preparing high-elasticity and high-strength artificial heart valve leaflets, including a yarn pretreatment unit, a weaving unit, a leaflet cutting unit, a valve molding unit, and a process control unit. The yarn pretreatment unit pretreats the spandex monofilament to obtain a first yarn; The weaving unit weaves the first yarn to obtain a first leaflet fabric; The leaflet cutting unit cuts the first leaflet blank into a preset first shape to obtain a second leaflet blank; The leaflet forming unit performs heat setting treatment on the second leaflet blank to obtain a target leaflet; The process control unit is in communication with the weaving unit and controls the weaving process through a data-driven mechanism.

[0009] The system for preparing the high-elasticity and high-strength artificial heart valve leaflets, wherein the spandex monofilament is a spandex monofilament with a diameter of 10-30 μm; and the first yarn is a plied yarn formed by twisting 2-4 spandex monofilaments.

[0010] The preparation system of the high-elasticity and high-strength artificial heart valve leaflets, wherein the yarn pretreatment unit includes a washing module, a drying module and a twist control module connected in sequence, the washing module washes the spandex monofilament; the drying module vacuum dries the washed spandex monofilament; the twist control module twists the dried spandex monofilament into the first yarn with a twist of 120-250T / m.

[0011] The preparation system of the high-elasticity and high-strength artificial heart valve leaflets, wherein the washing module includes a first-stage washing device, a second-stage washing device and a third-stage washing device connected in series in sequence, and the detergent in the washing module flows reversely through the spandex monofilament for washing, forming a three-stage countercurrent washing of the spandex monofilament.

[0012] The preparation system of the high-elasticity and high-strength artificial heart valve leaflets, wherein the detergent flows from the three-stage washing device into the washing module, passes through the three-stage washing device, the two-stage washing device, and the one-stage washing device in sequence, and the detergent continuously flows in reverse at a flow rate of 450mL / min-550mL / min.

[0013] The manufacturing system of the high-elasticity and high-strength artificial heart valve leaflet, wherein the process control unit includes a configuration data storage module, a description module, a scheduling module and a closed-loop control module, The configuration data storage module stores structured configuration data, wherein the configuration data includes weaving step identifiers and corresponding process parameters; The description module registers step descriptions of multiple knitting steps, wherein the step descriptions include execution logic and process parameter interfaces of the knitting steps, and the execution logic and process parameter interfaces are decoupled through interface isolation; The scheduling module obtains the corresponding configuration data and the step description of the corresponding weaving step based on reflection matching according to the configuration data and step description of the weaving task; calls the step description of the corresponding weaving step, and drives the weaving unit to execute the corresponding step according to the execution logic, process parameter interface and configuration data in the step description of the corresponding weaving step; The closed-loop control module collects process parameters during the weaving process in real time and compares them with the configuration data. When the deviation between the process parameters and the process data in the configuration data exceeds a first preset value, parameter correction is triggered.

[0014] The system for preparing the high-elasticity and high-strength artificial heart valve leaflets, wherein the weaving unit includes a yarn guide mechanism, a double needle plate actuator and a tension sensor, and the specific process of the weaving unit weaving the first yarn is as follows: The weaving unit obtains the step description and configuration data of the weaving steps output by the scheduling module from the process control unit; Yarn guide tension control: The yarn guide mechanism adjusts the yarn guide hook air pressure valve through the closed-loop control module according to the tension threshold in the configuration data, and uses the proportional-integral control algorithm to stabilize the tension at the standard tension value; Double needle plate rib weaving: The double needle plate actuator calls the double needle plate execution logic and process parameter interface in the preset step description to drive the needle plate to perform weaving according to the process of transition from rib structure to plain weave; The tension sensor sends the yarn guide tension data to the closed-loop control module in real time.

[0015] The preparation system of the high-elasticity and high-strength artificial heart valve leaflets, wherein the leaflet cutting unit includes a first laser cutting module, a second laser cutting module and a cutting adjustment module, the first laser cutting module is used for pre-cutting and positioning of the first leaflet blank, the second laser cutting module is used for cutting the first leaflet blank, and the cutting adjustment module controls the focal point distance between the two laser beams of the first laser cutting module and the second laser cutting module through XYZ three-axis displacement.

[0016] The system for preparing the high-elasticity and high-strength artificial heart valve leaflets, wherein the leaflet molding unit includes a first mold device, a second mold device, a sleeve, and a heating module, the sleeve is sleeved on the outer periphery of the first mold device and the second mold device, the first mold device includes a plurality of leaflet combination shapes matching the second leaflet blank, the second mold device matches the top surface shape of the plurality of leaflet combination shapes of the first mold device, and a leaflet space for accommodating the second leaflet blank is formed between the first mold device and the second mold device; The mold assembly consisting of the first mold device, the second mold device, and the sleeve is placed in the heating module, and the heating module performs heat setting treatment on the second leaflet blank to obtain the target leaflet.

[0017] The preparation system of the high-elasticity and high-strength artificial heart valve leaflets, wherein the execution logic and the process parameter interface in the step description are decoupled through interface isolation: an abstract interface of the weaving steps is defined for the execution logic, the process parameter interface is encapsulated as a step object, and the step object transmits the process parameters in a serialized manner through a marking interface, and the identifier of the step object enables the step object to be serialized.

[0018] The preparation system of the high-elastic high-strength artificial heart valve leaflet, wherein the scheduling module realizes step description matching based on reflection matching, and the realization is achieved through a Java reflection API, and specifically includes the following steps: Based on the step identification in the configuration data, the execution logic in the corresponding weaving step is called, the step file of the corresponding weaving step is loaded, the execution logic in the target step matched with the process parameter interface is obtained in the step file through the declared method, and the weaving step is dynamically executed through the calling command.

[0019] (Three) beneficial effects: the preparation system of the high-elastic high-strength artificial heart valve leaflet is provided, the dynamic modular design of the process control unit is realized, the flexible expansion and accurate control of the weaving process are realized, the closed-loop control and real-time parameter correction are realized, the consistency of the weaving precision and mechanical properties of the leaflet is ensured, the yarn pretreatment and forming process are coordinated, the high-elastic high-strength characteristics of the leaflet are enhanced, and the precise forming and multi-model adaptation of the leaflet are realized. BRIEF DESCRIPTION OF DRAWINGS

[0020] Figure 1 is a step schematic diagram of the preparation target leaflet of the preparation system of the high-elastic high-strength artificial heart valve leaflet of the application; Figure 2 is a process schematic diagram in which the scheduling module drives the weaving unit to execute corresponding steps according to the weaving task in the preparation system of the high-elastic high-strength artificial heart valve leaflet of the application; Figure 3 is a structure schematic diagram of the preparation system of the high-elastic high-strength artificial heart valve leaflet of the application. DETAILED DESCRIPTION

[0021] The application will be further described below in conjunction with preferred embodiments, and more details are set forth in the following description in order to fully understand the application, but the application can be implemented in various ways different from the description, and a person skilled in the art can make similar generalization and deduction according to actual application without departing from the connotation of the application, so the protection scope of the application should not be limited by the specific embodiments.

[0022] The accompanying drawings are schematic diagrams of embodiments of the application, and it should be noted that the drawings are only examples and are not drawn according to the condition of the same scale, and should not be used as a limitation on the actual claimed protection scope of the application.

[0023] A preparation system of a high-elastic high-strength artificial heart valve leaflet, as shown in Figure 3 , includes a yarn pretreatment unit, a weaving unit, a leaflet cutting unit, a valve forming unit and a process control unit. Figure 1As shown, the yarn pretreatment unit pretreats the spandex monofilament to obtain a first yarn. The weaving unit weaves the first yarn to obtain a first leaflet blank. The leaflet cutting unit cuts the first leaflet blank into a preset first shape to obtain a second leaflet blank. The leaflet molding unit performs heat setting treatment on the second leaflet blank to obtain a target leaflet. The process control unit is in communication with the weaving unit, the leaflet cutting unit, and the leaflet molding unit, and controls the weaving, cutting, and molding processes through a data-driven mechanism.

[0024] The process control unit can achieve real-time communication with the weaving unit, the leaflet cutting unit, and the leaflet molding unit through industrial Ethernet (PROFINET protocol), and the data transmission delay is ≤10ms. The process control unit serves as the core control module and is connected to the weaving unit through a dual-channel redundant communication link to ensure high reliability of the weaving process.

[0025] The yarn pretreatment unit includes a washing module, a drying module, and a twist control module connected in sequence. The washing module washes the spandex monofilaments; the drying module vacuum dries the washed spandex monofilaments; and the twist control module twists the dried spandex monofilaments into the first yarn.

[0026] The spandex monofilament has a diameter range of 10–30 μm, a breaking strength ≥8 cN / dtex, and an elastic recovery rate ≥95% after 100% stretching. Here, a medical spandex monofilament with a diameter of 20 μm and a tolerance of ±1 μm is used as an example. The first yarn is a plied yarn formed by twisting 2–4 of the spandex monofilaments. Here, a plied yarn formed by twisting 3 of the spandex monofilaments is used as an example. The washing module washes the spandex monofilaments using a low-residual solvent. A low-residual solvent is defined as a solvent that meets the non-toxic requirements of cytotoxicity testing, such as 0.9% sterile saline.

[0027] The twist control module twists the dried spandex monofilament into a yarn having a twist of 120-250 T / m, a linear density of 50-80 dtex, and an elongation at break of 300-400%, namely the first yarn. The yarn having a twist of 120-250 T / m has a uniform axial orientation.

[0028] The yarn pretreatment unit includes a washing module, a drying module, and a twist control module connected in sequence. The washing module washes the spandex monofilaments. The drying module vacuum dries the washed spandex monofilaments. The twist control module twists the dried spandex monofilaments into the first yarn with a twist of 120-250 T / m.

[0029] The washing module comprises a first-stage washing device, a second-stage washing device and a third-stage washing device connected in series, and the washing agent in the washing module flows reversely through the spandex filaments to form a three-stage reverse flow washing of the spandex filaments.

[0030] Therefore, the washing agent is a low-residual solvent, for example, 0.9% sterile normal saline. The flow rate of the washing agent in the washing device flowing reversely through the spandex filaments is 450 mL / min-550 mL / min, and the total washing time is 10-20 min. Preferably, the flow rate is 500 mL / min, and the total washing time is 15 min. The washing temperature of the washing module is 35-39℃, and the optimal temperature is 37℃. Through the reverse flow of the washing agent and the spandex filaments, the spinning oil on the surface of the spandex filaments is effectively removed, and the washing efficiency is improved and the solvent consumption is reduced by using a multi-stage gradient concentration difference.

[0031] The first-stage washing device, the second-stage washing device and the third-stage washing device can be washing tanks or washing cavities, which are not specifically limited here. The washing agent flows into the washing module through the flow inlet of the third-stage washing device, and then sequentially passes through the third-stage washing device, the second-stage washing device and the first-stage washing device. The impurity concentration of the washing agent flowing through the third-stage washing device is the lowest, the impurity concentration of the washing agent flowing through the second-stage washing device is increased, and the impurity concentration of the washing agent flowing through the first-stage washing device is the highest. The spandex filaments first enter the first-stage washing device with the highest impurity concentration, and most of the spinning oil on the surface of the spandex filaments is preliminarily dissolved. As the spandex filaments enter the second-stage washing device and the third-stage washing device, the impurity concentration of the washing agent they contact gradually decreases. At this time, a small amount of oil remaining on the surface of the spandex filaments will diffuse into the solvent due to the concentration difference, achieving deep removal. The washing agent continuously flows reversely at a flow rate of 450 mL / min-550 mL / min, ensuring that there is always a gradient difference between the oil concentration on the surface of the spandex filaments and the oil concentration in the washing agent in each stage of the washing device, thereby avoiding the reverse adsorption of impurities.

[0032] The drying module can be a vacuum drying oven with a vacuum degree of ≤-0.09 MPa, a temperature of 45℃±5℃, a drying time of 2 h and a water content of ≤0.5%, for example, a vacuum drying oven with a model of DZF-6050.

[0033] The twist control module is a double-spindle twisting machine driven by a servo motor with an adjustable speed of 0-3000 r / min. The twist is adjusted in real time through tension feedback (accuracy ±0.5 cN) to ensure that the uniformity variation coefficient of the ply yarn twist is ≤5%.

[0034] The weaving unit includes a yarn guide mechanism, a double needle plate actuator, and a tension sensor. The weaving unit obtains the step description and configuration data of the weaving steps output by the scheduling module from the process control unit. Yarn guide tension control: The yarn guide mechanism adjusts the yarn guide hook air pressure valve through the closed-loop control module based on the tension threshold in the configuration data, and uses a proportional-integral control algorithm to stabilize the tension at a standard tension value of 5–8 cN. Double needle plate rib weaving: The double needle plate actuator calls the double needle plate execution logic and process parameter interface in the preset step description to drive the needle plate to perform weaving according to the process of transitioning from rib structure to plain weave. The tension sensor sends the yarn guide tension data to the closed-loop control module in real time, and the closed-loop control module controls the yarn guide mechanism to maintain constant tension on the first yarn.

[0035] In the yarn guide tension control, the process control unit sends configuration data (for example, a tension threshold of 5±0.5 cN), and the air pressure valve of the yarn guide mechanism adjusts the air pressure (proportional coefficient Kp=2.5, integral time Ti=0.5s) through the proportional-integral control algorithm (PI algorithm), stabilizing the tension within the standard range with a fluctuation range of ≤±0.3 cN. In double needle plate rib weaving, the double needle plate actuator calls the double needle plate execution logic in the step description and drives the needle plate to execute according to the following parameters: Rib section: needle plate traverse speed 300 mm / s, coil density 20 coils / cm; Transition section (5 cm length): coil density increases linearly to 30 coils / cm; Plain weave section: needle plate reciprocating frequency 5Hz, weaving speed 0.5m / min.

[0036] The yarn guide mechanism is also used to guide the first yarn into the knitting area, and the yarn guide mechanism includes a yarn guide hook. The double needle plate execution mechanism includes a front needle plate and a rear needle plate arranged opposite to each other, and is used to execute the knitting of the rib structure.

[0037] The yarn guide mechanism includes 16 independent yarn guide hooks made of TC4 titanium alloy with a surface roughness of Ra ≤ 0.8 μm. Each yarn guide hook is equipped with a precision air pressure valve. A closed-loop control module dynamically adjusts the air pressure of the precision air pressure valve to achieve dynamic adjustment of the first yarn tension. The precision air pressure valve has an adjustment range of 0.01–0.5 MPa and a response time of ≤ 10 ms. An example of a precision air pressure valve is the SMC ITV2030.

[0038] The front and rear needle plates of the double needle plate actuator are made of medical-grade stainless steel, measuring 200mm x 150mm, with a needle pitch of 0.5mm and a total needle count of 400. The needle plates are driven by a linear motor with a maximum speed of 500mm / s and a positioning accuracy of ±0.01mm.

[0039] The tension sensor can be a miniature tension and pressure sensor with a range of 0–50 cN, an accuracy of ±0.1 cN, and a sampling frequency of 1 kHz. The tension sensor is mounted 5 mm from the yarn guide outlet and collects real-time tension data of the first yarn, i.e., the actual tension value PV of the first yarn. For example, a miniature tension and pressure sensor model HBM U9B can be used.

[0040] The closed-loop control module is preset with a standard tension value SP, which is any value between 5 and 8 cN, preferably SP=5 cN.

[0041] The yarn guide hook air pressure valve is adjusted through the closed-loop control module, and the proportional-integral control algorithm is used to stabilize the tension at the standard tension value. The specific steps include the following: When the tension sensor feeds back the actual tension value PV to the closed-loop control module of the process control unit, the closed-loop control module calculates the current tension deviation e. The calculation formula is: e(t)=SP-PV(t), t is the current time, e(t) is the tension deviation at the current time, and PV(t) is the actual tension value at the current time.

[0042] The closed-loop control module calculates the adjustment amount of the air pressure valve according to the current tension deviation e(t) through the proportional P and integral I links, and outputs the control signal u(t): Proportional P link: output adjustment amount according to deviation e(t) , the calculation formula is, , Among them, the proportional coefficient Kp determines the response intensity, It indicates the output adjustment amount of the proportional link in PI control and is one of the direct control signals for driving the yarn guide hook air pressure valve.

[0043] Integral I link: Calculate the integral adjustment amount based on the continuous deviation e(t) on the time axis : , Among them, the integral adjustment amount It is the control signal output by the integral link, which is used to eliminate static error; is the integration coefficient, ; is the definite integral symbol, which is the cumulative sum of the deviation from time 0 to the current time tt; is the deviation function, that is, the integral variable, which represents the integral variable Tension deviation at the moment; is the time differential element, is the small interval of integral time (continuous time domain), which is discretized by sampling period Δt, when the sampling frequency is 1 kHz, Δt = 0.001 s.

[0044] Since the tension is stabilized at the standard tension value, it is not necessary to rely on the deviation change rate prediction, When calculating the total adjustment amount, the calculation formula is, .

[0045] Specifically, the total adjustment amount is , The differential element predicts the trend of the deviation of the lag system, but the sampling frequency of the tension sensor is high (the sampling frequency is not less than 1 kHz), the response is fast (the closed-loop delay is < 10 ms), there is no significant lag to be compensated, and the core requirement is to eliminate static error, so PI has met the requirement; The differential element significantly amplifies the effect of high-frequency noise (such as sensor fluctuation ± 0.1 cN), which can cause the air pressure valve to frequently fine-tune and damage the tension stability, which conflicts with the requirements of the weaving process; PID cannot meet the requirements of medical devices without overshoot and low noise due to differential oscillation.

[0046] The weaving unit also includes a needle lifting mechanism and a width control mechanism. The needle lifting mechanism includes a needle lifting comb and a weight assembly for the starting and shaping of the first leaflet fabric during weaving. The width control mechanism presets and adjusts the weaving width of the first leaflet fabric during weaving.

[0047] When the weaving unit weaves the first yarn, the following steps are included, (1) The first yarn is threaded through the guide hook through the yarn guide mechanism, the closed-loop control module adjusts the tension of the first yarn in real time, so that the tension of the first yarn is the first preset tension value, and then the guide hook feeds the first yarn into the lower part of the front needle plate and the rear needle plate of the double needle plate knitting module and fixes it, ensuring that the first yarn maintains constant tension during weaving; (2) Start the needle lifting mechanism, the needle lifting mechanism introduces the first yarn into the knitting area, and the starting and shaping of the fabric is completed through the needle lifting comb and the weight assembly; at the same time, the width control mechanism sets the width of the first leaflet fabric according to the preset first width parameter, and completes the initial weaving preparation; (3) The front needle plate and the rear needle plate of the double needle plate actuator work cooperatively, interweave according to the rib organization weaving execution logic, and form an inner dense structure; during this process, the width control unit monitors the fabric size in real time to ensure that the weaving width meets the design requirements.

[0048] (4) The double needle plate actuator repeatedly performs step (3) until the width control mechanism detects that the fabric reaches a first preset size, thereby obtaining a first leaflet blank.

[0049] The leaflet cutting unit uses laser cutting to cut the first leaflet blank into a preset first shape to obtain a second leaflet blank.

[0050] The leaflet cutting unit includes a first laser cutting module, a second laser cutting module, a cutting adjustment module and a cutting parameter database. The cutting parameter database stores preset contour morphological data of the valve leaflets, including standard contour sizes of the aortic valve, mitral valve and tricuspid valve. The first laser cutting module pre-cuts and positions the first leaflet blank according to the preset contour morphological data in the cutting parameter database, the second laser cutting module is used for cutting the first leaflet blank, and the cutting adjustment module controls the focal point distance between the two laser beams of the first laser cutting module and the second laser cutting module through XYZ three-axis displacement.

[0051] The first cutting module is an infrared laser emitter with a wavelength of 1064 nm, and the second laser cutting module is an ultraviolet laser emitter with a wavelength of 355 nm.

[0052] The leaflet cutting unit also includes a fabric tension feedback module and an adjustment module. The fabric tension feedback module includes multiple fiber optic sensors spaced evenly along the feed direction of the first leaflet fabric. These sensors monitor tension fluctuations in the first leaflet fabric during cutting in real time. The adjustment module dynamically adjusts the feed roller speed based on the first leaflet fabric tension fluctuations, keeping the tension fluctuation amplitude in the cutting area within ±3%.

[0053] The leaflet forming unit heat-sets the second leaflet fabric to form a predetermined three-dimensional shape, thereby obtaining a target leaflet. The heat-setting temperature is controlled to be above the glass transition temperature and below the melting temperature of the spandex yarn, i.e., 80-120°C, and the treatment time is 10-30 minutes.

[0054] The leaflet molding unit includes a first mold device, a second mold device and a sleeve, the sleeve is arranged on the outer periphery of the first mold device and the second mold device, the first mold device includes a plurality of leaflet combination shapes matching the second leaflet blank, the second mold device matches the top surface shape of the plurality of leaflet combination shapes of the first mold device, and a leaflet space for accommodating the second leaflet blank is formed between the first mold device and the second mold device.

[0055] The leaflet molding unit also includes a heating module. The mold assembly consisting of the first mold device, the second mold device, and the sleeve is placed in the heating module. The heating module performs heat setting treatment on the second leaflet blank to obtain the target leaflet.

[0056] The process control unit includes a configuration data storage module, a description module, a scheduling module, and a closed-loop control module. The configuration data storage module stores structured configuration data, wherein the configuration data includes a weaving step identifier and corresponding process parameters. The description module registers step descriptions of multiple weaving steps, wherein the step descriptions include the execution logic and process parameter interface of the weaving steps, and the description module decouples the execution logic and the process parameter interface from each other. Specifically, the execution logic and the process parameter interface are decoupled through interface isolation. The scheduling module obtains the corresponding configuration data and the step description of the corresponding weaving step based on reflection matching in the configuration data and step description of the weaving task; calls the step description of the corresponding weaving step, and drives the weaving unit to execute the corresponding step according to the execution logic, process parameter interface, and configuration data in the step description of the corresponding weaving step. The closed-loop control module collects the process parameters of the weaving process in real time and compares them with the configuration data. When the deviation between the process parameters and the configuration data exceeds a first preset value, parameter correction is triggered.

[0057] Structured configuration data is stored in an industrial-grade SD card with a read and write speed of ≥100MB / s and supports power-off data protection.

[0058] The description module decouples the execution logic and the process parameter interface from each other through the interface isolation principle, specifically including: The process control unit defines an abstract interface for the weaving steps of the execution logic, wherein the abstract interface includes an abstract method, the abstract interface includes a unified type identifier of the process parameter interface, and the abstract method is used to declare the execution logic entry of the weaving steps; the specific behaviors in the execution logic are defined through the abstract interface, for example, yarn guide tension control is a specific behavior in the execution logic. When defining the abstract interface of yarn guide tension control, only the yarn guide tension control is defined to control the tension of the yarn guide.

[0059] The process parameter interface is encapsulated into a step object, that is, each process parameter interface is encapsulated into a step object, and each step object corresponds to a marking interface of a process parameter. The marking interface is an encapsulation rule of the step object. For example, the process parameter interface is encapsulated into an independent step object, the step object implements a language interface, the step object includes a structured storage field of the process parameter, for example, a tension threshold minTension, maxTension, a unit cN, a fabric density density, a unit needle / inch, and the like. The step object can implement reading and writing of the parameter, and the parameter data is serialized for cross-module transmission.

[0060] When the execution unit executes a specific behavior, the weaving unit obtains the required process parameter through the step object And the step object transmits the serialized process parameter through the marking interface, and the identification of the step object enables the step object to be serialized.

[0061] The description module can also dynamically decouple and update the execution logic and the process parameter interface: When a weaving step needs to be added, the step description of the added weaving step is uploaded to the description module through the input unit, and the step description of the added weaving step covers the step description of the same weaving step. For example, when a weaving step is added, the user uploads a step description file through the input unit, and the system automatically checks the interface matching, and covers the original same step description after the verification is passed.

[0062] The scheduling module implements step description matching based on reflection matching, specifically including: Based on the step identification in the configuration data, the execution logic in the corresponding weaving step is called, and the step file of the corresponding weaving step is loaded. In the step file, the execution logic in the target step matched with the process parameter interface is obtained through the declared method, and the weaving step is dynamically executed through the calling command. The step file can be a step file of the corresponding weaving step.

[0063] In the configuration data storage module, the step identification adopts a structured naming of prefix plus number, for example: Ribbon weaving step: WEAVING_RIB_001; Plain transition step: WEAVING_PLAIN_002; Each step identification is stored in a relational database of the process control unit through a mapping table and is associated to a corresponding step fully qualified name.

[0064] As Figure 2 shown, the weaving task is parsed, and the target step is located: the scheduling module parses the step identification from the configuration data, and finds the corresponding weaving step fully qualified name.

[0065] Specifically, input: structured step identifiers in the configuration data; query mapping relationship: access the relational database of the configuration data storage module, query the mapping table between step identifiers and step fully qualified names, and verify version compatibility (for example, configuration data version V1.2 must match the version number of the step description); output: target step fully qualified name (unique identifier) ​​and step file path.

[0066] Safely load the step file and generate the step object: The scheduling module calls the step loader, loads the step file of the target step, and generates the step object after verifying the integrity.

[0067] Specifically, step file loading: The step loader reads the step file according to the path and converts it into a step object. Security verification: Hash verification calculates the bytecode SHA-256 value and compares it with the hash value stored in the configuration data. Signature verification verifies the digital signature of the step file, trusting only the signature issued by the process control unit. Exception handling: If verification fails, an alarm is triggered and an attempt is made to load an alternative version of the bytecode. Output: The step object that passes verification.

[0068] Matching execution logic with process parameter interface: The scheduling module queries the description module, extracts the execution logic from the step object, and verifies its compatibility with the process parameter interface.

[0069] Specifically, extract the target method: obtain the execution logic method, the parameter type is the process parameter interface predefined in the description module; interface matching verification: the description module provides interface metadata (such as the fully qualified name of the interface, method signature), and the scheduling module verifies whether the parameters are consistent with the interface required by the configuration data; output: the successfully matched execution logic object (execution logic entry) and the parameter interface list.

[0070] Dynamically call execution logic and drive weaving unit: The scheduling module calls the weaving step instance, drives the weaving unit to execute the weaving logic and monitor the process.

[0071] Specifically, instantiate the weaving steps: create a target step instance; pass in the process parameter interface implementation steps: extract the process parameters (such as tension threshold 5cN, speed 300mm / s) from the configuration data, instantiate the process parameter interface implementation steps, and encapsulate the implementation step objects as parameter arrays; reflective call method: the weaving unit drives the yarn guide mechanism and the double needle plate actuator according to the method logic. During the execution process, the monitoring data is fed back to the process control unit in real time; exception handling and closed-loop control: when the reflection is abnormal, it automatically retries the call ≤3 times, and switches to the backup step if it fails; process parameter deviation, the closed-loop control module collects data in real time. If the deviation exceeds the threshold (such as tension > 5.5cN), the parameter correction is triggered and re-execution is performed.

[0072] The scheduling module points to a specific implementation step object through an interface reference when calling a behavior unit, and passes the serialized step object as a parameter to realize decoupling calling of abstract interface calling and general parameter injection.

[0073] The highly compliant mechanical responsiveness of the artificial heart valve leaflet is achieved, the artificial heart valve leaflet has good structural weaving and size controllability, the three-dimensional structure design and individual customization of the artificial heart valve leaflet are facilitated, and excellent fatigue life and biological safety are achieved, meeting the requirements of long-term implantation and stable operation.

[0074] The specific implementation of the yarn guide mechanism and the yarn tension control includes that the closed loop control module of the process control unit collects the yarn tension in real time through the tension sensor, sends an instruction to the yarn guide mechanism when the detected value deviates from the 5-8 cN interval in the configuration data, and drives the step motor of the yarn guide mechanism to vertically displace the yarn guide hook until the tension returns to the standard tension value.

[0075] The specific process of the double needle plate actuator for rib weaving includes that after the scheduling module of the process control unit calls the member method of the double needle plate rib weaving class, the double needle plate actuator drives the needle plate to move horizontally and lift according to the parameters (such as the front needle bed density of 16 needles / inch and the back needle bed density of 14 needles / inch) in the configuration data through the triangular trajectory control module of the double needle plate actuator to complete the cycle weaving of the rib structure; at the same time, the loop density detector of the double needle plate actuator triggers detection once every 10 rows of weaving, and feeds back data to the closed loop control module to correct the needle bed displacement accuracy.

[0076] Through the data-driven and reflection scheduling mechanism of the process control unit, the automation and parameter controllability of the weaving process are ensured.

[0077] The scheduling module further includes a step description verification unit, which performs legality verification on the registered step description before matching the target step, and the verification content includes whether the member method parameter list of the step description matches the process parameter interface (such as the tension threshold and the fabric width) in the configuration data, and the method return value type is the preset “execution status code” (0=success, 1=parameter exception, 2=device failure).

[0078] The reflection mechanism supports polymorphic calling: when multiple weaving steps implement the same interface, the scheduling module dynamically binds the specific sub-step according to the step identifier in the configuration data, for example, the double needle plate rib weaving corresponds to the woven fabric, the plain weave transition corresponds to the plain weave weaving, and the sub-step rewrites the interface method and needs to include the process parameter adaptive logic (such as automatically adjusting the needle bed density according to the yarn diameter).

[0079] The scheduling module is coupled with the process parameter cache unit. When the member method of the target step is reflectively called, the recently used process parameters (such as the tension threshold of the "yarn guide tension control" for the last three times) are read from the cache unit first. If the deviation between the cached data and the configuration data is ≤1%, the cached parameters are directly reused to reduce calculation delay.

[0080] The reflection mechanism also includes an exception capture and rollback unit: when a non-existent step method or illegal access is triggered during the reflection call process, it automatically rolls back to the previous weaving step, records the exception stack information through the log framework, and sends a "step retry instruction" to the process control unit.

[0081] The data unit and the behavior unit achieve asynchronous communication through a message queue: the data unit encapsulates process parameters (such as a tension threshold of 5–8 cN) as a message and sends it to the message queue; the behavior unit triggers the execution logic by listening to queue messages, and when message consumption fails, it automatically enters the dead letter queue and is redelivered after manual intervention.

[0082] The data unit in the step description is stored in a structured configuration file, which may be in XML format, including: the behavior unit reads the XML file through a DOM parser to achieve format decoupling from the data unit.

[0083] Decoupling is enhanced through dependency injection (DI) container: the process control unit has a built-in control inversion container, which injects the data unit into the behavior unit. The control inversion container automatically manages the life cycle of the step objects (e.g., create → use → destroy), avoiding coupling caused by the behavior unit directly instantiating the data unit.

[0084] The preparation system of high-elasticity and high-strength artificial heart valve leaflets, with three major innovations: dynamic modular control of reflective scheduling, closed-loop tension and double-needle plate weaving process, and high-precision yarn pretreatment and molding collaboration, solves the technical problems in the preparation of traditional artificial heart valve leaflets, such as the difficulty in expanding process curing, poor consistency of mechanical properties, and high cost of adapting multiple models. The prepared leaflets have shown significant improvements in elastic recovery rate, dimensional accuracy and fatigue life.

[0085] 1. Realize full-process automated integration, improve the coordinated response speed of each unit, reduce communication failure rate, and ensure continuous production; accurately control weaving process parameters and improve product stability.

[0086] 2. Meet the requirements of heart valve cycle fatigue and adapt to high-frequency opening and closing; improve the yarn tear resistance, avoid loose yarn during weaving, and evenly increase the fabric surface density; effectively remove spinning oil, avoid residual impurities causing inflammatory reactions, reduce low moisture content, and extend the storage life of the yarn.

[0087] 3. Reduce yarn wear rate and tension fluctuations to avoid the risk of leaflet tearing caused by local stress concentration; accurately control the coil density of rib and plain transition weaving to ensure the gradient distribution of mechanical properties between the leaflet edge and center area; provide real-time feedback of tension data to improve adjustment efficiency.

[0088] 4. New weaving steps can be added without stopping the machine, shortening the expansion cycle; the interface matching verification method improves the call success rate; the coupling between the execution logic and the parameter interface is reduced, reducing the system maintenance cost; the yarn guide tension stabilization time is shortened, and the correction response speed when the parameter deviation in the weaving process exceeds the threshold is greatly improved.

[0089] 5. The leaflet size error is small, meeting the needs of individual customization and high cutting efficiency; the leaflet three-dimensional shape fixation rate is improved and the thermal shrinkage rate is reduced, avoiding the risk of paravalvular leakage caused by size changes after implantation.

[0090] 6. High traceability of process parameters and long data storage life meet GMP requirements for the full life cycle management of medical products; improve the system's mean troubleshooting time and enhance troubleshooting efficiency.

[0091] The preparation system for high-elasticity and high-strength artificial heart valve leaflets can adapt to the design requirements of different leaflet structures; it improves the accuracy of key parameters such as guide yarn tension control and double needle plate positioning, and improves the consistency of leaflet mechanical properties; it uses high molecular polymer materials + sterile pretreatment process to reduce the incidence of inflammatory reactions after leaflet implantation and increase the implant life.

[0092] The above content is an explanation of the preferred embodiments of the present invention, which can help those skilled in the art to more fully understand the technical solutions of the present invention. However, these embodiments are merely illustrative, and it cannot be determined that the specific implementation methods of the present invention are limited to the description of these embodiments. For those skilled in the art of the present invention, without departing from the concept of the present invention, several simple deductions and transformations can be made, which should be deemed to fall within the scope of protection of the present invention.

Claims

1. A system for preparing high-elasticity and high-strength artificial heart valve leaflets, characterized in that: It includes yarn pretreatment unit, weaving unit, leaflet cutting unit, valve molding unit and process control unit. The yarn pretreatment unit pretreats the spandex monofilament to obtain a first yarn; The weaving unit weaves the first yarn to obtain a first leaflet fabric; The leaflet cutting unit cuts the first leaflet blank into a preset first shape to obtain a second leaflet blank; The leaflet forming unit performs heat setting treatment on the second leaflet blank to obtain a target leaflet; The process control unit is in communication with the weaving unit and controls the weaving process through a data-driven mechanism.

2. The system for preparing the high-elasticity and high-strength artificial heart valve leaflet according to claim 1, characterized in that: The spandex monofilament is a spandex monofilament with a diameter of 10-30 μm; the first yarn is a plied yarn formed by twisting 2-4 spandex monofilaments.

3. The system for preparing the high-elasticity and high-strength artificial heart valve leaflet according to claim 1, characterized in that: The yarn pretreatment unit comprises a washing module, a drying module and a twist control module connected in sequence, wherein the washing module washes the spandex monofilament; and the drying module vacuum dries the washed spandex monofilament. The twist control module twists the dried spandex monofilament into the first yarn with a twist of 120-250 T / m.

4. The system for preparing the high-elasticity and high-strength artificial heart valve leaflet according to claim 3, characterized in that: The washing module comprises a primary washing device, a secondary washing device and a tertiary washing device connected in series in sequence. The detergent in the washing module flows countercurrently through the spandex monofilaments to wash them, forming a three-stage countercurrent washing of the spandex monofilaments.

5. The system for preparing the high-elasticity and high-strength artificial heart valve leaflet according to claim 4, characterized in that: The detergent enters the washing module from the three-stage washing device, passes through the three-stage washing device, the two-stage washing device, and the one-stage washing device in sequence, and the detergent continuously flows in the reverse direction at a flow rate of 450 mL / min-550 mL / min.

6. The system for preparing high-elasticity and high-strength artificial heart valve leaflets according to claim 1, characterized in that: The process control unit includes a configuration data storage module, a description module, a scheduling module and a closed-loop control module. The configuration data storage module stores structured configuration data, wherein the configuration data includes weaving step identifiers and corresponding process parameters; The description module registers step descriptions of multiple knitting steps, wherein the step descriptions include execution logic and process parameter interfaces of the knitting steps, and the execution logic and process parameter interfaces are decoupled through interface isolation; The scheduling module obtains the corresponding configuration data and the step description of the corresponding weaving step based on reflection matching according to the configuration data and step description of the weaving task; calls the step description of the corresponding weaving step, and drives the weaving unit to execute the corresponding step according to the execution logic, process parameter interface and configuration data in the step description of the corresponding weaving step; The closed-loop control module collects process parameters during the weaving process in real time and compares them with the configuration data. When the deviation between the process parameters and the process data in the configuration data exceeds a first preset value, parameter correction is triggered.

7. The system for preparing the high-elasticity and high-strength artificial heart valve leaflet according to claim 6, characterized in that: The weaving unit includes a yarn guide mechanism, a double needle plate actuator and a tension sensor. The specific process of the weaving unit weaving the first yarn is as follows: The weaving unit obtains the step description and configuration data of the weaving steps output by the scheduling module from the process control unit; Yarn guide tension control: The yarn guide mechanism adjusts the yarn guide hook air pressure valve through the closed-loop control module according to the tension threshold in the configuration data, and uses the proportional-integral control algorithm to stabilize the tension at the standard tension value; Double needle plate rib weaving: The double needle plate actuator calls the double needle plate execution logic and process parameter interface in the preset step description to drive the needle plate to perform weaving according to the process of transition from rib structure to plain weave; The tension sensor sends the yarn guide tension data to the closed-loop control module in real time.

8. The system for preparing high-elasticity and high-strength artificial heart valve leaflets according to claim 1, characterized in that: The leaflet cutting unit includes a first laser cutting module, a second laser cutting module and a cutting adjustment module. The first laser cutting module is used for pre-cutting and positioning of the first leaflet blank, the second laser cutting module is used for cutting the first leaflet blank, and the cutting adjustment module controls the focal point distance between the two laser beams of the first laser cutting module and the second laser cutting module through XYZ three-axis displacement.

9. The system for preparing high-elasticity and high-strength artificial heart valve leaflets according to claim 1, characterized in that: The leaflet molding unit includes a first mold device, a second mold device, a sleeve, and a heating module. The sleeve is sleeved on the outer periphery of the first mold device and the second mold device. The first mold device includes a plurality of leaflet combination shapes matching the second leaflet blank. The second mold device matches the top surface shape of the plurality of leaflet combination shapes of the first mold device. A leaflet space for accommodating the second leaflet blank is formed between the first mold device and the second mold device. The mold assembly consisting of the first mold device, the second mold device, and the sleeve is placed in the heating module, and the heating module performs heat setting treatment on the second leaflet blank to obtain the target leaflet.

10. The system for preparing high-elasticity and high-strength artificial heart valve leaflets according to claim 6, characterized in that: The execution logic and process parameter interface in the step description are decoupled through interface isolation: an abstract interface for weaving steps is defined for the execution logic, the process parameter interface is encapsulated as a step object, and the step object serializes and transmits the process parameters through the tag interface, and the identifier of the step object enables the step object to be serialized.

11. The system for preparing high-elasticity and high-strength artificial heart valve leaflets according to claim 6, characterized in that: The scheduling module implements step description matching based on reflection matching, specifically including: Based on the step identifier in the configuration data, the execution logic in the corresponding weaving step is called, and the step file of the corresponding weaving step is loaded. In the step file, the execution logic in the target step that matches the process parameter interface is obtained by obtaining the declaration method, and the weaving step is dynamically executed by calling the command.

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