System for preparing high-elastic high-strength artificial heart valve leaflets

Abstract

A system for preparing high-elasticity, high-strength artificial heart valve leaflets includes a yarn pretreatment unit, a braiding unit, a leaflet cutting unit, a leaflet forming unit, and a process control unit. The yarn pretreatment unit pretreats spandex monofilaments to obtain a first yarn; the braiding unit braids the first yarn to obtain a first leaflet fabric; the leaflet cutting unit cuts the first leaflet fabric into a preset first shape to obtain a second leaflet fabric; the leaflet forming unit heat-sets the second leaflet fabric to obtain the target leaflet; the process control unit is communicatively connected to the braiding unit and controls the braiding process through a data-driven mechanism. This invention achieves flexible expansion and precise control of the braiding process, closed-loop control and real-time parameter correction, ensuring consistency in leaflet braiding accuracy and mechanical properties. The synergy between yarn pretreatment and forming processes enhances the high-elasticity and high-strength characteristics of the leaflets, enabling precise leaflet forming and multi-model adaptation.

Description

Technical Field

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

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

[0003] Mechanical valves are typically made of metal alloys (such as cobalt-chromium alloys, carbon materials, etc.), which have the advantages of long service life and high structural stability, and can maintain valve function in the body for a long time. However, the interface between the metal material and blood is not conducive to endothelialization, requiring patients to undergo lifelong anticoagulation therapy, which increases the risk of bleeding and thrombotic complications.

[0004] Bioprosthetic valves are primarily derived from xenogeneic animal pericardium (such as bovine or porcine) or autologous tissue, exhibiting good biocompatibility and a low tendency to thrombosis. However, because natural tissues or biomimetic materials are prone 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. This is especially true in young patients who require frequent replacements, and the difficulty in mass-producing them consistently limits their widespread application.

[0005] In addition, traditional valve manufacturing materials cannot simultaneously meet key performance requirements such as flexibility, durability, mechanical adaptability, and individual adjustability.

[0006] Therefore, the existing technology has problems and needs further improvement and development. Summary of the Invention

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

[0008] (II) Technical Solution: To solve the above-mentioned technical problems, this technical solution provides a preparation system for a high-elasticity and high-strength artificial heart valve leaflet, including a yarn pretreatment unit, a braiding unit, a leaflet cutting unit, a leaflet forming unit, and a process control unit.

[0009] The yarn pretreatment unit pretreats the spandex monofilament to obtain the first yarn;

[0010] The weaving unit weaves the first yarn to obtain the first leaf-shaped fabric;

[0011] The leaf cutting unit cuts the first leaf fabric into a preset first shape to obtain the second leaf fabric.

[0012] The leaflet forming unit heat-sets the second leaflet fabric to obtain the target leaflet.

[0013] The process control unit is communicatively connected to the weaving unit and controls the weaving process through a data-driven mechanism.

[0014] The high-elasticity and high-strength artificial heart valve leaflet preparation system includes a spandex monofilament with a diameter of 10–30 μm; and a first yarn made of 2–4 strands of the spandex monofilament twisted together.

[0015] The high-elasticity and high-strength artificial heart valve leaflet preparation system includes a yarn pretreatment unit comprising 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; and the twist control module twists the dried spandex monofilament into the first yarn with a twist of 120–250 T / m.

[0016] The high-elasticity and high-strength artificial heart valve leaflet preparation system includes a washing module comprising a primary washing device, a secondary washing device, and a tertiary washing device connected in series. The detergent in the washing module flows counter-currently through the spandex monofilament for washing, forming a tertiary counter-current washing of the spandex monofilament.

[0017] In the preparation system for the high-elasticity and high-strength artificial heart valve leaflet, the detergent flows into the washing module from the three-stage washing device and passes sequentially through the three-stage washing device, the two-stage washing device, and the one-stage washing device, with the detergent continuously flowing in the opposite direction at a flow rate of 450 mL / min-550 mL / min.

[0018] The fabrication system for the high-elasticity, high-strength artificial heart valve leaflets includes a process control unit comprising a data storage module, a description module, a scheduling module, and a closed-loop control module.

[0019] The configuration data storage module stores structured configuration data, which includes weaving step identifiers and corresponding process parameters.

[0020] The description module registers step descriptions for multiple weaving steps. The step descriptions include the execution logic and process parameter interfaces of the weaving steps. The execution logic and process parameter interfaces are decoupled through interface isolation.

[0021] The scheduling module obtains the corresponding configuration data and the corresponding step description of the 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.

[0022] 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.

[0023] The high-elasticity, high-strength artificial heart valve leaflet fabrication system includes a weaving unit comprising a yarn guiding mechanism, a double-needle plate actuator, and a tension sensor. The specific process by which the weaving unit weaves the first yarn is as follows:

[0024] The weaving unit obtains the step description and configuration data of the weaving steps output by the scheduling module from the process control unit;

[0025] Yarn tension control: The yarn guiding mechanism adjusts the air pressure valve of the yarn guiding hook through the closed-loop control module according to the tension threshold in the configuration data, and uses a proportional-integral control algorithm to stabilize the tension at the standard tension value;

[0026] Double-needle plate rib knitting: The double-needle plate actuator calls the double-needle plate execution logic and process parameter interface in the preset step description, driving the needle plate to perform knitting according to the process of transitioning from rib to plain weave;

[0027] The tension sensor sends the yarn tension data to the closed-loop control module in real time.

[0028] The high-elasticity and high-strength artificial heart valve leaflet fabrication system includes a leaflet cutting unit comprising 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 the first leaflet fabric, the second laser cutting module is used for cutting the first leaflet fabric, and the cutting adjustment module controls the focal distance between the two laser beams of the first and second laser cutting modules through XYZ three-axis displacement.

[0029] The high-elasticity and high-strength artificial heart valve leaflet preparation system includes a leaflet forming unit comprising a first mold device, a second mold device, a sleeve, and a heating module. The sleeve is fitted around the outer periphery of the first mold device and the second mold device. The first mold device includes a multi-leaflet combination shape that matches the second leaflet fabric. The second mold device matches the top surface shape of the multi-leaflet combination shape of the first mold device. A leaflet space for accommodating the second leaflet fabric is formed between the first mold device and the second mold device.

[0030] 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 fabric to obtain the target leaflet.

[0031] The fabrication system for the high-elasticity and high-strength artificial heart valve leaflet, wherein 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 transmits the process parameters serialized through a tag interface, and the identifier of the step object enables the step object to be serialized.

[0032] The fabrication system for the high-elasticity, high-strength artificial heart valve leaflet, wherein the scheduling module implements step description matching based on reflection matching, and is implemented through the Java reflection API, specifically including:

[0033] 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. The execution logic in the target step that matches the process parameter interface is obtained by obtaining the declaration method in the step file, and the weaving step is dynamically executed by calling the command.

[0034] (III) Beneficial effects: The present invention provides a preparation system for high elasticity and high strength artificial heart valve leaflets. The dynamic modular design of the process control unit enables flexible expansion and precise control of the weaving process. Closed-loop control and real-time parameter correction ensure the consistency of leaflet weaving accuracy and mechanical properties. The yarn pretreatment and molding process work together to enhance the high elasticity and high strength characteristics of the leaflets, and achieve precise leaflet molding and multi-model adaptation. Attached Figure Description

[0035] Figure 1 This is a schematic diagram of the steps in preparing the target leaflet using the high-elasticity, high-strength artificial heart valve leaflet preparation system of the present invention;

[0036] Figure 2 This is a schematic diagram of the process in which the scheduling module drives the weaving unit to execute corresponding steps according to the weaving task in the fabrication system of the high elasticity and high strength artificial heart valve leaflet of the present invention.

[0037] Figure 3 This is a schematic diagram of the fabrication system for the high-elasticity, high-strength artificial heart valve leaflet of the present invention. Detailed Implementation

[0038] The present invention will be further described in detail below with reference to preferred embodiments. More details are set forth in the following description in order to provide a full understanding of the present invention. However, the present invention can obviously be implemented in many other ways different from those described herein. Those skilled in the art can make similar extensions and derivations based on actual application situations without departing from the spirit of the present invention. Therefore, the scope of protection of the present invention should not be limited by the content of this specific embodiment.

[0039] The accompanying drawings are schematic diagrams of embodiments of the present invention. It should be noted that these drawings are for illustrative purposes only and are not drawn to scale, and should not be construed as limiting the actual scope of protection of the present invention.

[0040] A fabrication system for highly elastic and high-strength artificial heart valve leaflets, such as... Figure 3 As shown, it includes a yarn pretreatment unit, a braiding unit, a leaf cutting unit, a leaf forming unit, and a process control unit. Figure 1 As 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 petal-shaped fabric. The petal-shaped cutting unit cuts the first petal-shaped fabric into a preset first shape to obtain a second petal-shaped fabric. The petal-shaped forming unit heat-sets the second petal-shaped fabric to obtain the target petal. The process control unit is communicatively connected to the weaving unit, the petal-shaped cutting unit, and the petal-shaped forming unit, and controls the weaving, cutting, and forming processes through a data-driven mechanism.

[0041] The process control unit can communicate in real time with the braiding unit, the leaf cutting unit, and the leaf forming unit via industrial Ethernet (PROFINET protocol), with a data transmission delay of ≤10ms. The process control unit, as the core control module, is connected to the braiding unit through a dual-channel redundant communication link to ensure high reliability of the braiding process.

[0042] 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; and the twist control module twists the dried spandex monofilament into the first yarn.

[0043] The spandex monofilament is a spandex monofilament with a diameter ranging from 10 to 30 μm, a breaking strength ≥8 cN / dtex, and an elastic recovery rate ≥95% after 100% stretching. Here, a medical-grade spandex monofilament with a diameter of 20 μm and a tolerance of ±1 μm is used as an example. The first yarn is a ply yarn made by twisting 2–4 of the spandex monofilaments; here, a ply yarn made by twisting 3 of the spandex monofilaments is used as an example. The washing module uses a low-residual solvent to wash the spandex monofilament. Low-residual solvent refers to a non-toxic solvent that meets the requirements of cytotoxicity testing, such as 0.9% sterile saline.

[0044] The twist control module twists the dried spandex monofilament into a yarn with a twist of 120–250 T / m, a linear density of 50–80 dtex, and a breaking elongation of 300–400%, which is the first yarn. The yarn with a twist of 120–250 T / m has a uniform axial orientation.

[0045] 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 120–250 T / m.

[0046] The washing module includes a primary washing device, a secondary washing device, and a tertiary washing device connected in series. The detergent in the washing module flows in the opposite direction through the spandex monofilament for washing, forming a three-stage countercurrent washing of the spandex monofilament.

[0047] Therefore, the detergent is a low-residue solvent, such as 0.9% sterile saline. The detergent flows counter-currently through the spandex monofilament at a rate of 450 mL / min-550 mL / min, with a total washing time of 10-20 minutes. Preferably, the flow rate is 500 mL / min, and the total washing time is 15 minutes. The washing temperature of the washing module is 35-39℃, with an optimal temperature of 37℃. By using the counter-current flow of detergent and spandex monofilament, spinning oil on the surface of the spandex monofilament is efficiently removed. Simultaneously, a multi-stage gradient concentration difference is utilized to improve washing efficiency and reduce solvent consumption.

[0048] The primary, secondary, and tertiary washing devices can specifically be washing tanks or washing chambers, without specific limitations. The detergent flows into the washing module through the inlet of the tertiary washing device, passing sequentially through the tertiary, secondary, and primary washing devices. The detergent with the lowest impurity concentration flows through the tertiary washing device, the impurity concentration increases through the secondary washing device, and the impurity concentration is highest through the primary washing device. The spandex monofilament first enters the primary washing device with the highest impurity concentration, where most of the spinning oil on its surface is initially dissolved. As the spandex monofilament enters the secondary and tertiary washing devices, the impurity concentration of the detergent it comes into contact with gradually decreases. At this point, the small amount of oil remaining on the surface of the spandex monofilament diffuses into the solvent due to the concentration difference, achieving deep removal. The detergent flows continuously in the opposite direction at a flow rate of 450 mL / min-550 mL / min, ensuring that the surface oil concentration of the spandex monofilament is always greater than the gradient difference of the detergent oil concentration in each washing device, thus avoiding reverse adsorption of impurities.

[0049] The drying module can be a vacuum drying oven with a vacuum degree ≤-0.09MPa, a temperature of 45℃±5℃, a drying time of 2h, and a moisture content controlled at ≤0.5%, such as the vacuum drying oven model DZF-6050.

[0050] The twist control module is a double-spindle twisting machine driven by a servo motor, with an adjustable speed of 0–3000 r / min. It adjusts the twist in real time through tension feedback (accuracy ±0.5 cN) to ensure that the twist uniformity variation coefficient of the ply yarn is ≤5%.

[0051] The knitting unit includes a yarn guiding mechanism, a double-needle plate actuator, and a tension sensor. The knitting unit obtains the knitting step description and configuration data output by the scheduling module from the process control unit. Yarn guiding tension control: Based on the tension threshold in the configuration data, the yarn guiding mechanism adjusts the yarn guide hook air pressure valve through the closed-loop control module and uses a proportional-integral control algorithm to stabilize the tension at a standard tension value of 5–8 cN. Double-needle plate rib knitting: The double-needle plate actuator calls the double-needle plate execution logic and process parameter interface in the preset step description, driving the needle plate to perform knitting according to the transition from rib to plain weave. The tension sensor sends the yarn guiding tension data to the closed-loop control module in real time, and the closed-loop control module controls the yarn guiding mechanism to maintain a constant tension on the first yarn.

[0052] In yarn tension control, the process control unit issues configuration data (e.g., tension threshold 5±0.5cN). The pneumatic valve of the yarn guiding mechanism adjusts the air pressure using a proportional-integral (PI) control algorithm (proportional coefficient Kp=2.5, integral time Ti=0.5s) to stabilize the tension within the standard range, with fluctuation amplitude ≤±0.3cN.

[0053] In double-needle rib knitting, the double-needle plate actuator invokes the double-needle plate execution logic described in the step description, driving the needle plate to execute according to the following parameters:

[0054] Ribbed section: needle plate transverse speed 300mm / s, coil density 20 coils / cm;

[0055] Transition section (5cm length): Coil density increases linearly to 30 coils / cm;

[0056] Plain weave section: needle plate reciprocating frequency 5Hz, weaving speed 0.5m / min.

[0057] The yarn guiding mechanism is also used to guide the first yarn into the knitting area, and the yarn guiding mechanism includes a yarn guide hook. The double needle plate actuator includes a front needle plate and a rear needle plate arranged opposite each other, used to perform rib knitting.

[0058] The yarn guiding mechanism comprises 16 independent yarn guide hooks, all made of TC4 titanium alloy with a surface roughness Ra ≤ 0.8 μm. Each yarn guide hook is equipped with a precision pneumatic valve, and a closed-loop control module dynamically adjusts the air pressure of the valve to achieve dynamic adjustment of the tension of the first yarn. The precision pneumatic valve has an adjustment range of 0.01–0.5 MPa and a response time ≤ 10 ms; for example, it may be an SMC ITV2030 precision pneumatic valve.

[0059] The front and rear needle plates of the dual-needle plate actuator are made of medical-grade stainless steel, with dimensions of 200mm × 150mm, a needle pitch of 0.5mm, and a total needle count of up to 400. The needle plates are driven by a linear motor with a maximum speed of 500mm / s and a positioning accuracy of ±0.01mm.

[0060] The tension sensor can be a miniature tension / compression 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 installed 5 mm from the exit end of the yarn guide hook to collect the tension data of the first yarn in real time, i.e., the actual tension value PV of the first yarn, such as a miniature tension / compression sensor of model HBM U9B.

[0061] 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.

[0062] The tension is stabilized at the standard tension value by adjusting the air pressure valve of the yarn guide hook through a closed-loop control module and using a proportional-integral control algorithm. The specific steps include the following:

[0063] 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 using the following formula:

[0064] e(t) = SP - PV(t),

[0065] 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.

[0066] The closed-loop control module calculates the adjustment amount of the pressure valve based on the tension deviation e(t) at the current time through proportional P and integral I links, and outputs a control signal u(t):

[0067] Proportional P stage: Outputs adjustment amount based on deviation e(t) The calculation formula is as follows:

[0068] ,

[0069] Among them, the proportionality coefficient Kp determines the response intensity. This represents the output adjustment amount of the proportional element in PI control, and is one of the direct control signals for driving the air pressure valve of the yarn guide hook.

[0070] Integral I stage: Calculate the integral adjustment based on the continuous deviation e(t) on the time axis. :

[0071] ,

[0072] Among them, integral adjustment It is the control signal output by the integral element, used to eliminate static error; The integral coefficient is... ; The symbol is definite integral, which is the cumulative summation of the deviation from time 0 to the current time tt; The deviation function, i.e., the integral variable, represents the integral variable. The tension deviation at any given moment; The time differential element is a tiny interval of the integration time (continuous time domain), which is discretized by the sampling period Δt. When the sampling frequency is 1kHz, Δt=0.001s.

[0073] Since stabilizing the tension at the standard tension value eliminates the need to rely on predictions of the rate of change of deviation, therefore...

[0074] The formula for calculating the total adjustment is as follows:

[0075] .

[0076] Specifically, the total adjustment amount is due to the following reasons: ,

[0077] The differential element is used to predict the deviation trend of the lag system, but the tension sensor has a high sampling frequency (sampling frequency not less than 1kHz), fast response (closed-loop delay <10ms), no significant lag to compensate for, and the core requirement is the elimination of static error, so PI has already met the requirements.

[0078] The differential element has a significant amplification effect on high-frequency noise (such as sensor fluctuations of ±0.1cN), which will lead to frequent fine-tuning of the air pressure valve, disrupting tension stability and conflicting with the requirements of the weaving process.

[0079] PID controllers cannot meet the requirements of medical devices for no overshoot and low noise due to differential oscillations.

[0080] The knitting unit also includes a starting mechanism and a width control mechanism. The starting mechanism includes a starting comb and a counterweight assembly for shaping the first leaf fabric during knitting. The width control mechanism presets and adjusts the knitting width of the first leaf fabric during knitting.

[0081] When the weaving unit weaves the first yarn, it includes the following steps:

[0082] (1) The first yarn is passed through the yarn guide hook by the yarn guide mechanism. The closed-loop control module adjusts the tension of the first yarn in real time. After the tension of the first yarn is the first preset tension value, the yarn guide hook feeds the first yarn into the front needle plate and the rear needle plate of the double needle plate knitting module and fixes it to ensure that the first yarn maintains a constant tension during the weaving process.

[0083] (2) Start the needle-starting mechanism, which introduces the first yarn into the knitting area and completes the fabric start-up and shaping through the needle-starting comb and the weight assembly; at the same time, the width control mechanism sets the width of the first leaf fabric according to the preset first width parameter to complete the initial knitting preparation;

[0084] (3) The front and rear needle plates of the double needle plate actuator work together to interweave according to the rib knitting execution logic to form a dense inner structure. During this process, the width control unit monitors the fabric size in real time to ensure that the knitting width meets the design requirements.

[0085] (4) The double needle plate actuator repeats step (3) until the width control mechanism detects that the fabric has reached the first preset size, and the first leaf greige fabric is obtained.

[0086] The leaflet cutting unit uses laser cutting to cut the first leaflet fabric into a preset first shape to obtain the second leaflet fabric.

[0087] 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 morphology data of the valve leaflets, including the standard contour dimensions of the aortic, mitral, and tricuspid valves. The first laser cutting module pre-cuts and positions the first leaflet fabric according to the preset contour morphology data in the cutting parameter database. The second laser cutting module is used for cutting the first leaflet fabric. The cutting adjustment module controls the focal distance between the two laser beams from the first and second laser cutting modules through XYZ three-axis displacement.

[0088] The first cutting module is an infrared laser emitter with a wavelength of 1064nm, and the second laser cutting module is an ultraviolet laser emitter with a wavelength of 355nm.

[0089] The leaf cutting unit further includes a fabric tension feedback module and an adjustment module. The fabric tension feedback module includes multiple fiber optic sensors evenly spaced along the feed direction of the first leaf fabric. These fiber optic sensors monitor the tension fluctuation of the first leaf fabric in real time during the cutting process. The adjustment module dynamically adjusts the feed roller speed based on the tension fluctuation of the first leaf fabric, keeping the tension fluctuation amplitude in the cutting area within ±3%.

[0090] The petal forming unit heat-sets the second petal fabric to form a preset three-dimensional shape, thus obtaining the target petal. The heat-setting temperature is controlled above the glass transition temperature and below the melting temperature of the spandex yarn, i.e., 80-120℃, and the processing time is 10-30 minutes.

[0091] The petal forming unit includes a first mold device, a second mold device, and a sleeve. The sleeve is fitted around the outer periphery of the first mold device and the second mold device. The first mold device includes a multi-petal combination shape that matches the second petal fabric. The second mold device matches the top surface shape of the multi-petal combination shape of the first mold device. A petal space for accommodating the second petal fabric is formed between the first mold device and the second mold device.

[0092] The leaflet forming unit further 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 fabric to obtain the target leaflet.

[0093] 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, including weaving step identifiers and corresponding process parameters. The description module registers step descriptions for multiple weaving steps, each including the execution logic and process parameter interface of the weaving step. Specifically, the description module decouples the execution logic and process parameter interface through interface isolation. The scheduling module, based on the weaving task, retrieves the corresponding configuration data and the corresponding weaving step description from the configuration data and step descriptions using reflection matching. It then calls the corresponding weaving step description 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. 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 configuration data exceeds a first preset value, parameter correction is triggered.

[0094] Structured configuration data is stored on an industrial-grade SD card with a read / write speed of ≥100MB / s and supports power-loss data protection.

[0095] The description module decouples the execution logic and process parameter interfaces through the interface isolation principle, specifically including:

[0096] The process control unit defines an abstract interface for the knitting steps of the execution logic. The abstract interface includes an abstract method and a unified type identifier for the process parameter interface. The abstract method is used to declare the execution logic entry point of the knitting step. The abstract interface limits the specific behaviors in the execution logic. For example, yarn tension control is a specific behavior in the execution logic. When defining the abstract interface for yarn tension control, only the control of the yarn tension is defined.

[0097] The process parameter interface is encapsulated as a step object, meaning each process parameter interface is encapsulated as a separate step object, and each step object corresponds to a marker interface for a process parameter. The marker interface is the encapsulation rule for the step object. For example, the process parameter interface can be encapsulated as an independent step object, which implements a language interface. The step object includes structured storage fields for the process parameters, such as: tension thresholds minTension and maxTension, in cN; fabric density, in needles per inch, etc. The step object can read and write parameters and serialize parameter data for cross-module transmission.

[0098] When the execution unit performs a specific action, the weaving unit obtains the required process parameters through the step object.

[0099] Furthermore, the step object serializes and transmits process parameters through the marker interface, and the identifier of the step object enables the step object to be serialized.

[0100] The description module can also dynamically decouple and update the interface between the execution logic and the process parameters:

[0101] When a new knitting step needs to be added, a step description for the new knitting step is uploaded to the description module through the input unit. The step description of the new knitting step overwrites the step description of the same knitting step. For example, when adding a new knitting step, the user uploads a step description file through the input unit, the system automatically verifies the interface matching, and if the verification is successful, it overwrites the original step description of the same step.

[0102] The scheduling module implements step description matching based on reflection matching, specifically including:

[0103] Based on the step identifier in the configuration data, the execution logic of the corresponding weaving step is invoked, and the step file of the corresponding weaving step is loaded. The execution logic of the target step matching the process parameter interface is obtained through the method of obtaining the declaration in the step file, and the weaving step is dynamically executed by invoking commands. The step file can be the step file of the corresponding weaving step.

[0104] In the configuration data storage module, step identifiers use a structured naming convention with a prefix followed by numbers, for example:

[0105] Ribbed knitting steps: WEAVING_RIB_001;

[0106] Plain texture transition steps: WEAVING_PLAIN_002;

[0107] Each step identifier is stored in a mapping table in the relational database of the process control unit and associated with the corresponding fully qualified step name.

[0108] like Figure 2 As shown, the task is parsed to locate the target step: the scheduling module parses the step identifier from the configuration data and finds the fully qualified name of the corresponding knitting step.

[0109] Specifically, the input is the structured step identifier in the configuration data; the mapping relationship is queried by accessing the relational database of the configuration data storage module, querying the mapping table between the step identifier and the fully qualified name of the step, and verifying version compatibility (e.g., the configuration data version V1.2 needs to match the version number of the step description); the output is the fully qualified name (unique identifier) ​​of the target step and the path of the step file.

[0110] Securely load the step file and generate the step object: The scheduling module calls the step loader to load the step file of the target step, and generates the step object after verifying its integrity.

[0111] Specifically, the process involves: loading the step file, where the step loader reads the step file based on the path and converts it into a step object; and performing a security check, which calculates the SHA-256 value of the bytecode and compares it with the hash value stored in the configuration data.

[0112] Signature Verification: Verifies the digital signature of the procedure document, trusting only signatures issued by the process control unit. Exception Handling: Triggers an alarm upon verification failure and attempts to load an alternative version of bytecode. Output: The procedure object that passes verification.

[0113] Matching execution logic with process parameter interface: The scheduling module queries the description module to extract the execution logic from the step object and verify its compatibility with the process parameter interface.

[0114] Specifically, the target method is extracted by obtaining the execution logic method, and the parameter type is the predefined process parameter interface in the description module; the interface matching and verification is performed by the description module providing interface metadata (such as the fully qualified name of the interface and the method signature), and the scheduling module verifying whether the parameters are consistent with the interface required by the configuration data; the output is the successfully matched execution logic object (execution logic entry point) and the list of parameter interfaces.

[0115] Dynamically invoke execution logic to drive the weaving unit: The scheduling module calls the weaving step instance, drives the weaving unit to execute the weaving logic, and monitors the process.

[0116] Specifically, the process involves: instantiating the knitting step: creating a target step instance; passing in the process parameter interface implementation step: extracting process parameters (such as tension threshold of 5cN, speed of 300mm / s) from the configuration data, instantiating the implementation step of the process parameter interface, and encapsulating the implementation step object into a parameter array; reflecting and calling the method: the knitting unit drives the yarn guiding mechanism and the double needle plate actuator according to the method logic, and during the execution, real-time feedback monitoring data is sent to the process control unit; exception handling and closed-loop control: when the reflection is abnormal, the call is automatically retried ≤3 times, and if it fails, it switches to the backup step; for process parameter deviation, the closed-loop control module collects data in real time, and if the deviation exceeds the threshold (such as tension > 5.5cN), it triggers parameter correction and re-execution.

[0117] When the scheduling module calls the behavior unit, it points to the specific implementation step object through the interface reference and passes the serialized step object as a parameter, thereby realizing the decoupled call of abstract interface call + general parameter injection.

[0118] Achieving highly compliant mechanical responsiveness in artificial heart valve leaflets to adapt to the periodic high-frequency opening and closing load of the heart; ensuring that the fabricated artificial heart valve leaflets have good structural weaving properties and dimensional controllability, facilitating the three-dimensional structural design and individualized customization of artificial heart valve leaflets; and providing excellent fatigue life and biocompatibility to meet the requirements for long-term implantation and stable operation.

[0119] The specific implementation of the yarn guiding mechanism and yarn tension control includes the following: the closed-loop control module of the process control unit collects the yarn tension in real time through the tension sensor. When the detected value deviates from the 5-8cN range in the configuration data, it sends a command to the yarn guiding mechanism. The stepper motor of the yarn guiding mechanism drives the yarn hook to move vertically until the tension returns to the standard tension value.

[0120] The specific process of rib weaving by the dual-needle plate actuator includes: after the scheduling module of the process control unit calls the member method of the dual-needle plate rib weaving class, the dual-needle plate actuator drives the needle plate to move laterally and rise and fall through the triangular trajectory control module of the dual-needle plate actuator according to the parameters in the configuration data (such as front needle bed density of 16 needles / inch and rear needle bed density of 14 needles / inch) to complete the cyclic weaving of the rib structure; at the same time, the coil density detector of the dual-needle plate actuator triggers a detection every 10 rows of weaving, and feeds back the data to the closed-loop control module to correct the needle bed displacement accuracy.

[0121] By leveraging data-driven and reflective scheduling mechanisms from the process control unit, the automation and parameter controllability of the weaving process are ensured.

[0122] The scheduling module also includes a step description verification unit, which verifies the legality of the registered step description before matching the target step. The verification content includes: whether the member method parameter list of the step description matches the process parameter interface (such as tension threshold, fabric width) in the configuration data, and whether the method return value type is a preset "execution status code" (0=success, 1=parameter abnormality, 2=equipment failure).

[0123] The reflection mechanism supports polymorphic calls: when multiple knitting steps implement the same interface, the scheduling module dynamically binds specific sub-steps according to the step identifier in the configuration data. For example, double-needle plate rib knitting corresponds to machine knitting, and plain weave transition corresponds to plain weave structure knitting. When the sub-step rewrites the interface method, it must include adaptive logic for process parameters (such as automatically adjusting the needle bed density according to the yarn diameter).

[0124] The scheduling module is coupled with the process parameter caching unit. When the member method of the target step is called by reflection, the recently used process parameters (such as the tension threshold of the last 3 "yarn tension control") are read from the caching unit first. If the deviation between the cached data and the configuration data is ≤1%, the cached parameters are directly reused to reduce the calculation delay.

[0125] 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.

[0126] The data unit and the action unit communicate asynchronously through a message queue: the data unit encapsulates process parameters (such as tension threshold 5–8 cN) into messages and sends them to the message queue; the action unit triggers execution logic by listening to messages in the queue, and when message consumption fails, it automatically enters the dead letter queue, which is then resubmitted after manual intervention.

[0127] The data units described in the steps are stored using structured configuration files, which can be in XML format. This includes: the behavior unit reads the XML file through a DOM parser, thereby decoupling the format from the data unit.

[0128] Decoupling is enhanced through a dependency injection (DI) container: The process control unit has a built-in inversion of control container that injects data units into action units, and the inversion of control container automatically manages the lifecycle of step objects (e.g., creation → use → destruction), avoiding coupling caused by action units directly instantiating data units.

[0129] The high-elasticity and high-strength artificial heart valve leaflet fabrication system features three major innovations: dynamic modular control of reflection scheduling, closed-loop tension and double-needle plate weaving process, and high-precision yarn pretreatment and molding synergy. These innovations solve the technical problems of difficult process solidification and expansion, poor mechanical property consistency, and high cost of multi-model adaptation in the traditional artificial heart valve leaflet fabrication process. As a result, the fabricated leaflets show significant improvements in elastic recovery rate, dimensional accuracy, and fatigue life.

[0130] 1. Achieve full-process automated integration, improve the collaborative response speed of each unit, reduce the communication failure rate, and ensure continuous production; precisely control the knitting process parameters to improve product stability.

[0131] 2. Meets the fatigue requirements of heart valve circulation and is suitable for high-frequency opening and closing; improves the tear resistance of yarn, avoids yarn loosening during weaving, and uniformly increases the fabric surface density; effectively removes spinning oil, avoids residual impurities from causing inflammatory reactions, reduces low moisture content, and extends the yarn storage life.

[0132] 3. Reduce yarn wear and tension fluctuations to avoid the risk of leaflet tearing caused by localized stress concentration; precisely control the loop density of rib and plain weave transitions 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.

[0133] 4. No machine downtime is required when adding new weaving steps, shortening the expansion cycle; the interface matching and verification method improves the success rate of calls; the coupling between execution logic and parameter interface is reduced, reducing system maintenance costs; the yarn tension stabilization time is shortened, and the correction response speed when the parameter deviation in the weaving process exceeds the threshold is greatly improved.

[0134] 5. The leaflet size error is small, meeting individualized customization needs and with high cutting efficiency; the three-dimensional shape fixation rate of the leaflet is improved, the thermal shrinkage rate is reduced, and the risk of paravalvular leakage caused by size changes after implantation is avoided.

[0135] 6. The process parameters have high traceability and the data storage life is long, meeting the GMP requirements for the full life cycle management of medical products; it improves the mean time between failures (MTBF) of the system and enhances the efficiency of troubleshooting.

[0136] The high-elasticity and high-strength artificial heart valve leaflet fabrication system adapts to different leaflet structure design requirements; it improves the accuracy of key parameters such as guide yarn tension control and double needle plate positioning, and enhances the consistency of leaflet mechanical properties; it adopts high-molecular polymer materials and aseptic pretreatment process to reduce the incidence of post-implantation inflammatory response and extend implantation life.

[0137] The above description illustrates preferred embodiments of the present invention and helps those skilled in the art to more fully understand the technical solution of the present invention. However, these embodiments are merely illustrative and should not be construed as limiting the specific implementation of the present invention to these embodiments. For those skilled in the art, several simple deductions and modifications can be made without departing from the inventive concept, and all such modifications should be considered within the protection scope of the present invention.

Claims

1. A system for fabricating high-elasticity, high-strength artificial heart valve leaflets, characterized in that, It includes a yarn pretreatment unit, a braiding unit, a leaf cutting unit, a leaf forming unit, and a process control unit. The yarn pretreatment unit pretreats the spandex monofilament to obtain the first yarn; The weaving unit weaves the first yarn to obtain the first leaf-shaped fabric; The leaf cutting unit cuts the first leaf fabric into a preset first shape to obtain the second leaf fabric. The leaflet forming unit heat-sets the second leaflet fabric to obtain the target leaflet. The process control unit is communicatively connected to the weaving unit and controls the weaving process through a data-driven mechanism. 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, which includes weaving step identifiers and corresponding process parameters. The description module registers step descriptions for multiple weaving steps. The step descriptions include the execution logic and process parameter interfaces of the weaving steps. The execution logic and process parameter interfaces are decoupled through interface isolation. The scheduling module obtains the corresponding configuration data and the corresponding step description of the 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.

2. The fabrication system for high-elasticity and high-strength artificial heart valve leaflets 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 ply yarn made of 2–4 of the spandex monofilaments twisted together.

3. The fabrication system for high-elasticity, high-strength artificial heart valve leaflets according to claim 1, characterized in that, 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 120–250 T / m.

4. The fabrication system for high-elasticity and high-strength artificial heart valve leaflets according to claim 3, characterized in that, The washing module includes a primary washing device, a secondary washing device, and a tertiary washing device connected in series. The detergent in the washing module flows in the opposite direction through the spandex monofilament for washing, forming a three-stage countercurrent washing of the spandex monofilament.

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

6. The fabrication system for high-elasticity and high-strength artificial heart valve leaflets according to claim 1, characterized in that, The knitting unit includes a yarn guiding mechanism, a double-needle plate actuator, and a tension sensor. The specific process by which the knitting unit knits 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 tension control: The yarn guiding mechanism adjusts the air pressure valve of the yarn guiding hook through the closed-loop control module according to the tension threshold in the configuration data, and uses a proportional-integral control algorithm to stabilize the tension at the standard tension value; Double-needle plate rib knitting: The double-needle plate actuator calls the double-needle plate execution logic and process parameter interface in the preset step description, driving the needle plate to perform knitting according to the process of transitioning from rib to plain weave; The tension sensor sends the yarn tension data to the closed-loop control module in real time.

7. The fabrication system for 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 fabric, the second laser cutting module is used for cutting the first leaflet fabric, 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.

8. The fabrication system for high-elasticity and high-strength artificial heart valve leaflets according to claim 1, characterized in that, The petal forming unit includes a first mold device, a second mold device, a sleeve, and a heating module. The sleeve is fitted around the outer periphery of the first mold device and the second mold device. The first mold device includes a multi-petal combination shape that matches the second petal fabric. The second mold device matches the top surface shape of the multi-petal combination shape of the first mold device. A petal space for accommodating the second petal fabric 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 fabric to obtain the target leaflet.

9. The fabrication system for high-elasticity and high-strength artificial heart valve leaflets according to claim 1, 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 transmits the process parameters serialized through a tag interface. The identifier of the step object enables the step object to be serialized.

10. The fabrication system for high-elasticity and high-strength artificial heart valve leaflets according to claim 1, 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. The execution logic in the target step that matches the process parameter interface is obtained by obtaining the declaration method in the step file, and the weaving step is dynamically executed by calling the command.

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